Coverage of Certain Preventive Services Under the Affordable Care Act

Federal RegisterFeb 2, 2023

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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.

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):

Electronically.

You may submit electronic comments on this regulation to

https://www.regulations.gov.

Follow the “Submit a comment” instructions.

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.

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 (

www.dol.gov/ebsa

). 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 (

www.cms.gov/cciio

), and information on health care reform can be found at

www.HealthCare.gov.

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:

https://www.regulations.gov.

Follow the search instructions on that website to view public comments. CMS will not post on

regulations.gov

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.

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).

1 2

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.

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).

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.

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)).

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).

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

https://www.dol.gov/sites/dolgov/files/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf

and

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf.

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 https://www.hrsa.gov/womens-guidelines-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 https://www.hrsa.gov/womens-guidelines-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 https://www.hrsa.gov/womens-guidelines/index.html.

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

Johnson,

6:22-cv-201-JDK (E.D. Tex. Aug. 12, 2022).

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.

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:

See

section II.B of the preamble for a description of the applicable guidance.

• 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;

• 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;

• 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;

• 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

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;

• 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;

• 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,

and established the process for participating issuers to seek a user fee adjustment under the applicable accommodations;

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).

• 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

Burwell

(

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;

Wheaton College

Burwell,

134 S. Ct. 2806, 573 U.S. 958, 189 L. Ed. 2d 856 (2014).

• 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

Hobby Lobby Stores, Inc.;

Burwell

Hobby Lobby Stores, Inc.,

134 S. Ct. 2751, 573 U.S. 682, 189 L. Ed. 2d 675 (2014).

• 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;

• 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

Burwell;

Zubik

Burwell,

136 S. Ct. 1557 (2016).

• 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)

and that alternative accommodations were not feasible;

42 U.S.C. 2000bb-1,

et seq.

FAQs About Affordable Care Act Implementation Part 36 (Jan. 17, 2017), available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-36.pdf

and

https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/aca-faqs-part36_1-9-17-final.pdf.

• 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;

• 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;

• 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;

• 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;

• 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;

FAQs About Affordable Care Act Implementation Part 48 (Aug. 16, 2021), available at

https://www.cms.gov/files/document/faqs-part-48.pdf

and

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-48.pdf.

• 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;

and

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

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-51.pdf

and

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf.

• Frequently Asked Questions on July 28, 2022 (FAQs Part 54), which further clarified the contraceptive coverage requirement and currently applicable guidance.

FAQs About Affordable Care Act Implementation Part 54 (July 28, 2022), available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf

and

https://www.cms.gov/files/document/faqs-part-54.pdf.

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

Hobby Lobby Stores, Inc.

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

a compelling governmental interest.

In response to

Hobby Lobby,

the July 2015 final rules allowed closely held for-profit companies to access the existing accommodation process.

Burwell

Hobby Lobby Stores, Inc,

134 S. Ct. 2751 (2014).

Id.

at 2775-79.

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

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.

The Court anticipated that, on remand, the Courts of Appeals would “allow the parties sufficient time to resolve any outstanding issues between them.”

The Departments issued the July 2016 RFI to gather public comments in response to the

Zubik

decision.

Zubik

Burwell,

136 S. Ct. 1557, 1560 (2016).

Id.

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.

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.

578 U.S. 901.

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

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).

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.

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.

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.”

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.”

March for Life

Burwell,

128 F. Supp. 3d 116 (D.D.C. 2015).

Id.

at 134.

Real Alternatives

Sec'y of HHS,

150 F. Supp. 3d 419,

affirmed

867 F. 3d 338 (3d Cir. 2017).

Id.

at 349.

Id.

at 350.

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.

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.

82 FR 47856-47857.

83 FR 57627.

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.

They all asked the courts to enjoin the interim final rules.

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.

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.

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

that the Departments did not follow proper procedures in issuing the interim final rules, and that the interim final rules contradict the statute.

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.

California

Azar,

281 F. Supp. 3d 806 (N.D. Cal. 2017),

affirmed,

911 F.3d 558 (9th Cir. 2018).

See Pennsylvania

Trump,

281 F. Supp. 3d 553 (E.D. Pa. 2017),

affirmed,

930 F.3d 543 (3d Cir. 2019).

See Pennsylvania

Trump,

351 F. Supp. 3d 791 (E.D. Pa. 2019),

affirmed,

930 F.3d 543 (3d Cir. 2019); and

California

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).

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.

83 FR 57536, 57537-38.

In January 2020, the Supreme Court granted petitions for writ of certiorari in the

Trump

Pennsylvania

and

Little Sisters of the Poor Saints Peter and Paul Home

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.

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.

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.

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.

Little Sisters of the Poor Saints Peter & Paul Home

Pennsylvania,

140 S. Ct. 918 (2020).

Little Sisters of the Poor Saints Peter & Paul Home

Pennsylvania,

140 S. Ct. 2367, 2386 (2020).

Id.

at 2383-84.

See

appellees supplemental brief,

State of California

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 . . .”)

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

Azar,

and issued a permanent injunction covering a class of individuals and a class of employers, which was ultimately vacated by the Fifth Circuit.

DeOtte

Azar,

393 F. Supp. 3d 490 (N.D. Tex. 2019),

DeOtte

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

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.

The U.S. District Court for the District of Massachusetts ruled that the November 2018 final rules were neither arbitrary and capricious nor unconstitutional.

The

Massachusetts

litigation (now on appeal) is currently being held in abeyance, while

California

Becerra

and

Pennsylvania

Biden

are stayed.

See

Mem. & Order (Op.),

Massachusetts

Dept. of Health & Human Services,

No. 17-cv-11930 (D. Mass. Jan. 15, 2021), ECF No. 139.

Id.

See

Stay Order,

Massachusetts

Dept. of Health & Human Services,

No. 21-1076 (1st Cir. Mar. 12, 2021); Joint Status Report,

California

Becerra,

No. 4:17 cv 5783-HSG (N.D. Cal. Oct. 29, 2021); and Stay Order,

Pennsylvania

Biden,

No. 2:17-cv-04540-WB (E.D. Pa. March 8, 2021).

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,

regardless of religious affiliation.

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.

The contraceptive coverage requirement has resulted in more women using contraception, especially long-acting reversible contraceptives (LARCs), such as intrauterine devices (IUDs) and implants.

Without health insurance or other health coverage, contraception can be prohibitively expensive,

and the cost may deter women from obtaining needed care.

Unintended pregnancies have negative health consequences for both women and children.

Poor and low-income women are most likely to have an unintended pregnancy

and are also more likely to be unable to afford contraception. Further, the U.S. Supreme Court's decision in

Dobbs

Jackson Women's Health Organization,

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

contraception at no cost (other than the premium or contribution paid for health coverage

) 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.

Daniels, K., Mosher, W., & Jones, J. (2013). Contraceptive Methods Women Have Ever Used: United States, 1982-2010.

National Health Statistics Reports,

62: 1-15.

Jones, R.K. (2020). People of all Religions Use Birth Control and Have Abortions.

Guttmacher Institute. https://www.guttmacher.org/print/article/2020/10/people-all-religions-use-birth-control-and-have-abortions.

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

https://www.cdc.gov/nchs/products/databriefs/db388.htm.

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.

https://doi.org/10.1016/j.whi.2018.01.005.

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

https://www.healthaffairs.org/doi/10.1377/hlthaff.2015.0127.

Sonfield, A. (2011). “The Case for Insurance Coverage of Contraceptive Services and Supplies Without Cost-Sharing.”

Guttmacher Policy Review,

14(1): 7-15.

“Preventing Unplanned Pregnancy.”

National Conference of State Legislatures

(2021). Available at:

https://www.ncsl.org/research/health/preventing-unplanned-pregnancy.aspx.

Guttmacher Institute (2019). “Unintended Pregnancy in the United States.” Available at

https://www.guttmacher.org/sites/default/files/factsheet/fb-unintended-pregnancy-us.pdf.

Dobbs

Jackson Women's Health Organization,

No. 19-1392, 597 U.S. __(2022).

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.

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.

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.

Low-income women also have the least access to contraception through employer-sponsored health insurance.

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.

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.

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.

https://www.kff.org/womens-health-policy/issue-brief/womens-sexual-and-reproductive-health-services-key-findings-from-the-2020-kff-womens-health-survey/.

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. https://www.kff.org/wp-content/uploads/2019/10/Issue-Brief-Financing-Family-Planning-Services-for-Low-income-Women-1.pdf

Sawhill, I. & Guyot, K. (2019). “Preventing unplanned pregnancy: Lessons from the states.”

Brookings. https://www.brookings.edu/research/preventing-unplanned-pregnancy-lessons-from-the-states/.

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.

Payne, C., & Fanarjian, N. (2014). Seeking causes for race-related disparities in contraceptive use.

Virtual Mentor, 16

(10), 805-809.

https://doi.org/10.1001/virtualmentor.2014.16.10.jdsc1-1410.

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.

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.

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.

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.

https://doi.org/10.1097/AOG.0000000000004224.

See

The White House. (2022). White House Blueprint for Addressing the Maternal Health Crisis.

https://www.whitehouse.gov/wp-content/uploads/2022/06/Maternal-Health-Blueprint.pdf. 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.

https://doi.org/10.1001/jamainternmed.2018.4696.

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

https://iwpr.org/wp-content/uploads/2020/07/B381_Contraception-Access_Final.pdf.

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).

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.

The ACA is fundamentally “designed to broaden access to healthcare and insurance coverage.”

Further, the Women's Health Amendment was designed to expand access to the preventive care and screenings that

women require.

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.

86 FR 7793 (February 2, 2021).

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.

Religious Sisters of Mercy

Azar,

513 F. Supp. 3d 1113 (D.N.D. 2021).

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.

Also, on January 28, 2021, President Biden issued a Memorandum on “Protecting Women's Health at Home and Abroad.”

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.

86 FR 33077.

On April 5, 2022, President Biden issued Executive Order 14070, “Continuing to Strengthen Americans' Access to Affordable, Quality Health Coverage” (E.O. 14070).

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.

87 FR 20689.

On July 8, 2022, President Biden issued Executive Order 14076, “Protecting Access to Reproductive Healthcare Services (E.O. 14076).”

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.

87 FR 42053.

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.

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.

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.

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,

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.

See

Section VI.B.2. of this preamble, under the Benefits heading.

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

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

(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).

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.

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

comprehensive guidelines supported by HRSA for purposes of section 2713(a)(4) of the PHS Act. The currently applicable

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,

effective family planning practices, and sterilization procedures to prevent unintended pregnancy and improve birth outcomes.

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.

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

https://www.hrsa.gov/womens-guidelines.

The Departments note that the FDA approves, clears, and grants contraceptive products and not methods.

See https://www.hrsa.gov/womens-guidelines-2019.

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

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.

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.

The FDA does not and never has approved, granted, or cleared contraceptive methods, only contraceptive products.

See

FN 4,

supra.

See

Q14, available at

https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xii.pdf

and

www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_implementation_faqs12.html. See also

FN 61.

Id.

at Q15.

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.

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.

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

https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf.

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 https://www.hrsa.gov/womens-guidelines.

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 § 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.

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

is not an objecting entity or objecting individual. The preamble to the November 2018 final rules specified this prohibition with respect to exempt entities,

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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.

105

83 FR 57536, 57565.

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

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

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.

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.

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Little Sisters of the Poor Saints Peter and Paul Home

Pennsylvania,

140 S. Ct. 2367 (2020).

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

Corporation of Presiding Bishop of Jesus Christ of Latter-Day Saints

Amos,

483 U.S. 327, 339, 107 S. Ct. 2862 (1987).

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.

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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.

110

March for Life

Burwell,

128 F. Supp. 3d 116 (D.D.C. 2015).

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.

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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.

111

83 FR 57592, 57625 (November 15, 2018).

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.

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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

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.

112

83 FR 57536, 57602.

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.'

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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.

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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

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.

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.

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

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.

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).

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.

117

In 45 CFR 147.131, these proposed rules would eliminate reserved paragraphs (a) and (b), and redesignate paragraph (c) as paragraph (a).

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.

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.”)

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.

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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

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.

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.

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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).

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

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).

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

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

contraceptive services would be permitted to seek reimbursement from a participating issuer as defined under 45 CFR 156.50,

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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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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.

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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.

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.

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85 FR 71142, 71174.