Coverage of Certain Preventive Services Under the Affordable Care Act, 7236-7281 [2023-01981]

Download as PDF 7236 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules 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 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. AGENCY: 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 nongrandfathered 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 khammond on DSKJM1Z7X2PROD with PROPOSALS2 SUMMARY: VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 accordance with the individual contraceptive arrangement for eligible individuals would be able to be reimbursed for its costs by entering into an arrangement with an issuer on a Federally-facilitated Exchange or State Exchange on the Federal platform, which in turn may seek a user fee adjustment. DATES: To be assured consideration, comments must be received at one of the addresses provided below, by April 3, 2023. ADDRESSES: In commenting, please refer to file code CMS–9903–P. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–9903–P, P.O. Box 8016, Baltimore, MD 21244–8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–9903–P, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Jason Sandoval, Internal Revenue Service, Department of the Treasury, at (202) 317–5500; Beth Baum or Matthew Meidell, Employee Benefits Security Administration, Department of Labor, at (202) 693–8335; David Mlawsky, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at (410) 786–6851; for matters related to financial support, Allison Yadsko, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at (410) 786–1740. Customer Service Information: Individuals interested in obtaining information from the Department of Labor (DOL) concerning employmentbased 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/ PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 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. E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 Section 2713 of the PHS Act, as added by the ACA and incorporated into ERISA and the Code, requires nongrandfathered group health plans and health insurance issuers offering nongrandfathered 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.3 As relevant here, the 2011 HRSA-Supported Guidelines included sterilization procedures, patient education and counseling for women with reproductive capacity, and all Food and Drug Administration (FDA)-approved, cleared, or granted contraceptives, as prescribed by a health care provider (collectively, contraceptive services).4 1 In addition to the specified preventive services addressed in section 2713 of the PHS Act, section 3203 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), enacted on March 27, 2020, requires non-grandfathered group health plans and health insurance issuers offering nongrandfathered group or individual health insurance to cover any qualifying coronavirus preventive service without cost sharing, pursuant to section 2713(a) of the PHS Act (including the regulations under 26 CFR 54.9815–2713, 29 CFR 2590.715– 2713, and 45 CFR 147.130 (or any successor regulations)). 2 The final regulations generally provide that plans and issuers must cover a preventive service pursuant to a new or changed recommendation starting with the first plan year (or, in the individual market, policy year) that begins on or after the date that is one year after the date on which the new recommendation is issued. 26 CFR 54.9815–2713(b)(1); 29 CFR 2590.715–2713(b)(1); 45 CFR 147.130(b)(1). Coverage of qualifying coronavirus preventive services must begin on an expedited timeline. Public Law 116–136, 3203, 134 Stat. 367 (2020); 26 CFR 54.9815–2713T(b)(3); 29 CFR 2590.715–2713(b)(3); 45 CFR 147.130(b)(3). 3 The references to ‘‘women’’ in these proposed rules should be considered to include any individual potentially capable of becoming pregnant, including cisgender women, transgender men, and non-binary individuals. Plans and issuers are required to cover contraceptive services for all such individuals consistent with the requirements in 26 CFR 54.9815–2713, 29 CFR 2590.715–2713, and 45 CFR 147.130. See FAQs About Affordable Care Act Implementation (Part XXVI) (May 11, 2015), Q5, available at 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-andFAQs/Downloads/aca_implementation_faqs26.pdf. 4 The references in this document to ‘‘contraception,’’ ‘‘contraceptive,’’ ‘‘contraceptive coverage,’’ or ‘‘contraceptive services’’ generally include all contraceptives, sterilization, and related VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 Except as discussed later in this section, non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual 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 femalecontrolled U.S. Food and Drug Administrationapproved 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 awarenessbased methods, including the lactation amenorrhea method.’’ See https://www.hrsa.gov/womensguidelines-2016/. 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/. 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. TiceHarouff v. Johnson, 6:22–cv–201–JDK (E.D. Tex. Aug. 12, 2022). PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 7237 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 HRSASupported Guidelines as amended in 2019. HHS, DOL, and the Department of the Treasury (collectively, the Departments) previously issued rules and guidance implementing section 2713 of the PHS Act, including guidance specific to coverage of contraceptive services.5 The Departments also previously issued rules providing exemptions from the contraceptive coverage requirement for entities and individuals with moral or religious objections to contraceptive coverage, and accommodations through which objecting entities are not required to contract, arrange, pay, or provide a referral for contraceptive coverage while at the same time ensuring that participants, beneficiaries, and enrollees enrolled in coverage sponsored or arranged by an objecting entity could separately obtain contraceptive services at no cost. Specifically, the Departments have issued: • 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 5 See section II.B of the preamble for a description of the applicable guidance. E:\FR\FM\02FEP2.SGM 02FEP2 7238 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 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, 6 and established the process for participating issuers to seek a user fee adjustment under the applicable accommodations; • Interim final rules on August 27, 2014, at 79 FR 51092 (August 2014 interim final rules), which amended the July 2013 final rules in light of the United States Supreme Court’s interim order in connection with an application for an injunction in Wheaton College v. Burwell 7 (Wheaton interim order), and provided an alternative process that an eligible organization may use to provide notice of its religious objection to the coverage of contraceptive services; • Proposed rules on August 27, 2014, at 79 FR 51118 (August 2014 proposed rules), which proposed potential changes to the definition of ‘‘eligible organization’’ for purposes of the accommodation process in light of the Supreme Court’s decision in Burwell v. Hobby Lobby Stores, Inc.; 8 • Final rules on July 14, 2015, at 80 FR 41317 (July 2015 final rules), which 6 That accommodation process, which was the only process by which certain employers could avoid the contraceptive coverage requirement under the July 2013 final rules, now forms the basis for what is instead an optional accommodation process under final rules published on November 15, 2018, at 83 FR 57536 (November 2018 Religious Exemption final rules). 7 Wheaton College v. Burwell, 134 S. Ct. 2806, 573 U.S. 958, 189 L. Ed. 2d 856 (2014). 8 Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 573 U.S. 682, 189 L. Ed. 2d 675 (2014). VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 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 v. Burwell; 9 • Frequently Asked Questions on January 9, 2017 (FAQs Part 36), which summarized alternative potential accommodations and stated that the Departments were not modifying the existing accommodations because the Departments continued to be of the view that the existing accommodations were consistent with the Religious Freedom Restoration Act (RFRA) 10 and that alternative accommodations were not feasible; 11 • 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 9 Zubik v. Burwell, 136 S. Ct. 1557 (2016). U.S.C. 2000bb–1, et seq. 11 FAQs About Affordable Care Act Implementation Part 36 (Jan. 17, 2017), available at https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part36.pdf and https://www.cms.gov/cciio/resources/ fact-sheets-and-faqs/downloads/aca-faqs-part36_19-17-final.pdf. 10 42 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 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; 12 • Frequently Asked Questions on January 10, 2022 (FAQs Part 51), which acknowledged complaints received about compliance with the contraceptive coverage requirement and clarified currently applicable guidance; 13 and • Frequently Asked Questions on July 28, 2022 (FAQs Part 54), which further clarified the contraceptive coverage requirement and currently applicable guidance.14 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 nonreligious moral convictions. These lawsuits first led to the Supreme Court’s ruling in Burwell v. Hobby Lobby Stores, Inc.15 The Supreme Court ruled in Hobby Lobby that, under RFRA, the contraceptive coverage requirement could not be applied to closely held forprofit corporations because doing so imposed a substantial burden on the owners’ exercise of religion and was not the least restrictive means of advancing 12 FAQs About Affordable Care Act Implementation Part 48 (Aug. 16, 2021), available at https://www.cms.gov/files/document/faqs-part48.pdf and https://www.dol.gov/sites/dolgov/files/ EBSA/about-ebsa/our-activities/resource-center/ faqs/aca-part-48.pdf. 13 FAQs About Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementations (Jan. 10, 2022), available at 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-andFAQs/Downloads/FAQs-Part-51.pdf. 14 FAQs About Affordable Care Act Implementation Part 54 (July 28, 2022), available at https://www.dol.gov/sites/dolgov/files/EBSA/aboutebsa/our-activities/resource-center/faqs/aca-part54.pdf and https://www.cms.gov/files/document/ faqs-part-54.pdf. 15 Burwell v. Hobby Lobby Stores, Inc, 134 S. Ct. 2751 (2014). E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules a compelling governmental interest.16 In response to Hobby Lobby, the July 2015 final rules allowed closely held forprofit companies to access the existing accommodation process. Later, a second series of legal challenges were filed by religious nonprofit organizations that argued that the accommodation itself impermissibly burdened their religious beliefs. On May 16, 2016, the Supreme Court issued a per curiam decision in Zubik v. Burwell, vacating the judgments of the Courts of Appeals—most of which had ruled in the Departments’ favor—and remanding the cases ‘‘in light of the substantial clarification and refinement in the positions of the parties’’ that had been supplied in supplemental briefs.17 The Court anticipated that, on remand, the Courts of Appeals would ‘‘allow the parties sufficient time to resolve any outstanding issues between them.’’ 18 The Departments issued the July 2016 RFI to gather public comments in response to the Zubik decision. FAQs Part 36 summarized the public comments and suggestions regarding the accommodation process. In Zubik, the Court suggested that the parties submit to the court information about whether cost-free contraceptive coverage could be provided to employees, through the objecting employers’ health insurance issuers, without the employers having to provide any notice to the issuers or the Government.19 Some comments received in response to the July 2016 RFI suggested that such an accommodation process would not be acceptable to some employers with religious objections, and some comments suggested that it would create significant administrative and operational challenges that would potentially undermine individuals’ seamless access to full and equal health coverage, including contraceptive coverage. Commenters also noted that the process would not work for selfinsured 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. Beginning in 2015, lawsuits challenging the contraceptive coverage requirement were also filed by non16 Id. at 2775–79. v. Burwell, 136 S. Ct. 1557, 1560 (2016). 17 Zubik 18 Id. 19 578 U.S. 901. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 religious organizations with moral objections to contraceptive coverage. In one case, March for Life v. Burwell, a nonprofit, non-religious organization and two of the organization’s individual employees filed a complaint claiming that the contraceptive coverage requirement (1) violated the equal protection component of the Due Process Clause of the Fifth Amendment, (2) violated the individual employees’ rights under RFRA, (3) violated the individuals’ rights under the First Amendment’s Free Exercise Clause, and (4) was arbitrary and capricious under the Administrative Procedure Act (APA).20 Challenges by non-religious, nonprofit organizations led to conflicting opinions among Federal courts. On August 31, 2015, the District Court for the District of Columbia agreed with the March for Life plaintiffs on the organization’s equal protection claim and the employees’ RFRA claims, and while not ruling on the APA claim, issued a permanent injunction against the Departments.21 That injunction remains in place. Conversely, in another case, the U.S. Court of Appeals for the Third Circuit (Third Circuit) on August 4, 2017 held that Real Alternatives—a non-religious section 501(c)(3) nonprofit organization and a moral objector—was not similarly situated to a religious organization and was therefore not entitled to an exemption.22 The Third Circuit concluded that ‘‘a secular antiabortion group mirrors a single-issue interest group and not a religious organization that takes advantage of the Exemption.’’ 23 In refusing to extend the exemption to a secular nonprofit organization, the Third Circuit recognized the ‘‘vast history of legislative protections that single out and safeguard religious freedom but not moral philosophy.’’ 24 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 20 March for Life v. Burwell, 128 F. Supp. 3d 116 (D.D.C. 2015). 21 Id. at 134. 22 Real Alternatives v. Sec’y of HHS, 150 F. Supp. 3d 419, affirmed 867 F. 3d 338 (3d Cir. 2017). 23 Id. at 349. 24 Id. at 350. PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 7239 Exemption interim final rules, with respect to the new exemption for nonreligious nonprofit organizations, the Departments were aware of two small nonprofit organizations that had filed lawsuits raising non-religious moral objections to coverage of some contraceptives. HHS noted in the 2017 Moral Exemption interim final rules that both of those entities had fewer than five employees enrolled in health coverage, and both required all of their employees to agree with their opposition to the coverage as a condition of employment.25 In the November 2018 Moral Exemption final rules, without data available to estimate the actual number of entities that would make use of the expanded exemption for for-profit entities without publicly traded ownership interests and that object to the contraceptive coverage requirement based on sincerely held moral convictions, the Departments estimated that fewer than 10 entities, if any, would do so.26 Numerous states filed lawsuits challenging the October 2017 interim final rules, contending that the October 2017 interim final rules were both procedurally invalid and arbitrary and capricious, and thus violated the APA. Pennsylvania and New Jersey sued in the Eastern District of Pennsylvania, while Massachusetts sued in the District of Massachusetts, and California, Delaware, Maryland, New York, and Virginia sued in the Northern District of California.27 They all asked the courts to enjoin the interim final rules. Two Federal district courts issued preliminary injunctions blocking the October 2017 interim final rules nationwide. The Northern District of California did so based on the states’ likelihood of success on their procedural APA claim—that the interim final rules were invalid for failing to follow notice and comment rulemaking.28 On appeal, the Ninth Circuit affirmed the district court decision though it limited the geographic scope of the injunction to the five states that were then plaintiffs in the case. The Eastern District of Pennsylvania enjoined the interim final rules nationwide, holding that plaintiffs were likely to succeed on their claims 25 82 FR 47856–47857. FR 57627. 27 Nine other states later joined the California litigation: Connecticut, Hawaii, Illinois, Minnesota, North Carolina, Rhode Island, Vermont, Washington, and Oregon, along with the District of Columbia, and an additional three states (Colorado, Michigan, and Nevada) moved to intervene in June 2019. 28 California v. Azar, 281 F. Supp. 3d 806 (N.D. Cal. 2017), affirmed, 911 F.3d 558 (9th Cir. 2018). 26 83 E:\FR\FM\02FEP2.SGM 02FEP2 7240 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 that the Departments did not follow proper procedures in issuing the interim final rules, and that the interim final rules contradict the statute.29 While the preliminary injunctions were on appeal, the Departments issued the November 2018 Religious Exemption final rules and the November 2018 Moral Exemption final rules (together, the November 2018 final rules). The district courts in California and Pennsylvania both enjoined enforcement of the November 2018 final rules, and the courts of appeals upheld those injunctions.30 The November 2018 Religious Exemption final rules ultimately expanded existing exemptions for individuals and entities with religious objections to coverage of contraceptive services. All nonprofit and for-profit employers with sincerely held religious objections to contraceptive coverage became eligible for religious exemptions, as did private universities and colleges with religious objections with respect to student health insurance coverage. Those rules retained the existing accommodation process but made it optional.31 In January 2020, the Supreme Court granted petitions for writ of certiorari in the Trump v. Pennsylvania and Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania cases and consolidated them, to review whether the Departments had the authority to promulgate rules exempting employers with religious or moral objections from the requirement to cover contraceptive services.32 The Court held that the Departments have broad authority to identify and create both moral and religious exemptions and that the final rules were not procedurally invalid.33 The Court indicated that it was proper for the Departments to take RFRA into account when considering religious exemptions, but the Court did not decide whether the rules violated the APA’s arbitrary-and-capricious standard.34 In litigation following the Supreme Court’s decision, some plaintiffs continue to argue that the Departments did not sufficiently weigh 29 See Pennsylvania v. Trump, 281 F. Supp. 3d 553 (E.D. Pa. 2017), affirmed, 930 F.3d 543 (3d Cir. 2019). 30 See Pennsylvania v. Trump, 351 F. Supp. 3d 791 (E.D. Pa. 2019), affirmed, 930 F.3d 543 (3d Cir. 2019); and California v. Azar, 351 F. Supp. 3d 1267 (N.D. Cal. 2019) (enjoining the final rules with respect to 14 plaintiff states and the District of Columbia); affirmed, 941 F.3d 410 (9th Cir. 2019). 31 83 FR 57536, 57537–38. 32 Little Sisters of the Poor Saints Peter & Paul Home v. Pennsylvania, 140 S. Ct. 918 (2020). 33 Little Sisters of the Poor Saints Peter & Paul Home v. Pennsylvania, 140 S. Ct. 2367, 2386 (2020). 34 Id. at 2383–84. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 the benefits of expanded employer exemptions against the harms of depriving more women of contraceptive coverage.35 Individuals also filed lawsuits claiming that the contraceptive coverage requirement forced them to choose between (1) purchasing health insurance that forces them to subsidize abortion or (2) forgoing health insurance. The District Court for the Northern District of Texas agreed with the plaintiffs in a class action lawsuit, DeOtte v. Azar, and issued a permanent injunction covering a class of individuals and a class of employers, which was ultimately vacated by the Fifth Circuit.36 The states continue to challenge the November 2018 final rules as arbitrary and capricious in three lawsuits. In Massachusetts v. Dept. of Health & Human Services, Massachusetts argued that the moral exemption is overbroad, and that the Departments failed to consider the reliance interests of women who stand to lose contraceptive coverage due to either of the exemptions.37 The U.S. District Court for the District of Massachusetts ruled that the November 2018 final rules were neither arbitrary and capricious nor unconstitutional.38 The Massachusetts litigation (now on appeal) is currently being held in abeyance, while California v. Becerra and Pennsylvania v. Biden are stayed.39 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 35 See appellees supplemental brief, State of California v. Azar, Nos. 19–15072, 19–15118, 19– 15150 (9th Cir., Aug. 28, 2020). (‘‘For example, the court will have to determine . . . whether defendants’ justifications are implausible because the Exemption Rules are not tailored to address the purported problems that the Rules identify . . .’’) 36 DeOtte v. Azar, 393 F. Supp. 3d 490 (N.D. Tex. 2019), DeOtte v. Nevada, No. 19–10754 (5th Cir. Dec. 17, 2021). 37 See Mem. & Order (Op.), Massachusetts v. Dept. of Health & Human Services, No. 17-cv-11930 (D. Mass. Jan. 15, 2021), ECF No. 139. 38 Id. 39 See Stay Order, Massachusetts v. Dept. of Health & Human Services, No. 21–1076 (1st Cir. Mar. 12, 2021); Joint Status Report, California v. Becerra, No. 4:17 cv 5783–HSG (N.D. Cal. Oct. 29, 2021); and Stay Order, Pennsylvania v. Biden, No. 2:17–cv–04540–WB (E.D. Pa. March 8, 2021). PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 their lifetime, 40 regardless of religious affiliation.41 The Centers for Disease Control and Prevention (CDC) found that 65.3 percent of American women aged 15 to 49 years were using contraception from 2017 to 2019.42 The contraceptive coverage requirement has resulted in more women using contraception, especially long-acting reversible contraceptives (LARCs), such as intrauterine devices (IUDs) and implants.43 Without health insurance or other health coverage, contraception can be prohibitively expensive,44 and the cost may deter women from obtaining needed care.45 Unintended pregnancies have negative health consequences for both women and children.46 Poor and low-income women are most likely to have an unintended pregnancy 47 and are also more likely to be unable to afford contraception. Further, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, 48 which allows for Federal and State laws that significantly limit access to abortion and thus removes one key option for women in making health care decisions, has placed a heightened importance on access to contraceptive services nationwide. Ensuring access to 40 Daniels, K., Mosher, W., & Jones, J. (2013). Contraceptive Methods Women Have Ever Used: United States, 1982–2010. National Health Statistics Reports, 62: 1–15. 41 Jones, R.K. (2020). People of all Religions Use Birth Control and Have Abortions. Guttmacher Institute. https://www.guttmacher.org/print/article/ 2020/10/people-all-religions-use-birth-control-andhave-abortions. 42 National Center for Health Statistics, Current Contraceptive Status Among Women Aged 15–49: United States, 2017–2019. Daniels, K., & Abma, J.C. (2020) Current contraceptive status among women aged 15–49: United States, 2017–2019. NCHS Data Brief, no 388. Hyattsville, MD: National Center for Health Statistics. Available at https://www.cdc.gov/ nchs/products/databriefs/db388.htm. 43 Snyder, A. H., Weisman, C. S., Liu, G., Leslie, D., & Chuang, C. H. (2018). The Impact of the Affordable Care Act on Contraceptive Use and Costs among Privately Insured Women. Women’s health issues: official publication of the Jacobs Institute of Women’s Health, 28(3), 219–223. https://doi.org/ 10.1016/j.whi.2018.01.005. 44 Becker, N.V. & Polsky, D. (2015). Women Saw Large Decrease in Out-Of-Pocket Spending for Contraceptives After ACA Mandate Removed Cost Sharing. Health Affairs, 34(7): 1204–1208. Available at https://www.healthaffairs.org/doi/10.1377/ hlthaff.2015.0127. 45 Sonfield, A. (2011). ‘‘The Case for Insurance Coverage of Contraceptive Services and Supplies Without Cost-Sharing.’’ Guttmacher Policy Review, 14(1): 7–15. 46 ‘‘Preventing Unplanned Pregnancy.’’ National Conference of State Legislatures (2021). Available at: https://www.ncsl.org/research/health/ preventing-unplanned-pregnancy.aspx. 47 Guttmacher Institute (2019). ‘‘Unintended Pregnancy in the United States.’’ Available at https://www.guttmacher.org/sites/default/files/ factsheet/fb-unintended-pregnancy-us.pdf. 48 Dobbs v. Jackson Women’s Health Organization, No. 19–1392, 597 U.S. __(2022). E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 contraception at no cost (other than the premium or contribution paid for health coverage 49) is a national public health imperative, as it is a means to prevent unintended pregnancies and help provide better health and economic outcomes for women, so that they can exercise control over their reproductive health and family planning decisions, particularly in states with prohibitions or tight restrictions on abortion. In previous rulemakings, the Departments established exemptions and accommodations for a variety of entities. Although the November 2018 final rules expanded religious exemptions, the Departments have concluded that these rulemakings did not give sufficient consideration to women’s significant interests in access to contraceptive services. Requiring individuals with low incomes to pay out-of-pocket for contraceptive services creates a disproportionate financial burden and unnecessary barrier to care for those individuals who must spend a greater percentage of their income on contraceptive services.50 The exemptions also ignore the government interest in promoting coverage for contraceptive services and assuring access to contraception. Furthermore, section 1 of Executive Order 13985, ‘‘Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government’’ (E.O. 13985), instructs the Federal Government to consider ways to affirmatively advance equity, civil rights, racial justice, and equal opportunity, with an emphasis on including historically marginalized communities and individuals. As noted previously, requiring individuals to pay out-of-pocket for contraceptive services will disproportionately burden lowwage workers. A considerable percentage of low-income women in the U.S. already rely on safety-net clinics 49 For ease of reference, this preamble describes the proposed individual contraceptive arrangement as providing access to contraceptive services ‘‘at no cost.’’ However, individuals eligible for the individual contraceptive arrangement would typically have to pay a premium or contribution to enroll in the group health plan or health insurance coverage sponsored, arranged, or provided by an objecting entity. 50 Although many women try and use multiple contraceptive methods for various reasons, nearly one in five women (18 percent) say they are not currently using their preferred method of birth control. The primary reason women say they are not using their preferred method of contraception is because they cannot afford it. See Frederiksen, B., Ranji, U., Salganikoff, A., & Long, M., (2021), Women’s Sexual and Reproductive Health Services: Key Findings from the 2020 KFF Women’s Health Survey. https://www.kff.org/womens-health-policy/ issue-brief/womens-sexual-and-reproductivehealth-services-key-findings-from-the-2020-kffwomens-health-survey/. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 7241 for contraception services.51 Lowincome women also have the least access to contraception through employer-sponsored health insurance.52 Given that non-white women are overrepresented among low-wage workers, exemptions for employers of low-wage workers from requiring coverage for contraceptive services could further disproportionately burden non-white women by limiting their access to contraceptive coverage and reproductive care through employersponsored coverage. This decrease in access to health care has also resulted in an increase in the prevalence of unplanned pregnancies for non-white and low-income individuals.53 In addition, historically marginalized communities and individuals are disproportionately affected by racial biases in health care. Racial bias has led to more skepticism about the safety of women’s health care and less knowledge about the efficacy of various forms of birth control for family planning among non-white women.54 The disparities in maternal health among women of different races can be addressed in part by removing financial barriers to accessing contraceptive services. Racial-ethnic disparities in access to reproductive health care, including contraceptive services, are widespread.55 Improving access to contraceptive services is critical to narrowing disparities in reproductive health access and outcomes, as well as longer-term outcomes. Access to postpartum contraception is important to increase spacing between pregnancies, as short intervals between pregnancies can be associated with adverse health outcomes.56 Access to contraceptive services without cost sharing increases knowledge about safe and effective forms of birth control planning and decreases financial constraints that prevent continuation of appropriate contraception use for women in marginalized communities. Additionally, access to contraceptive services has wide-ranging economic effects for women, from increased educational attainment to increases in labor force participation and lifetime earnings.57 In addition to addressing the policy objectives discussed previously, these proposed rules are consistent with meeting the objectives of several Executive Orders and a Presidential Memorandum issued by President Biden. On January 28, 2021, President Biden issued Executive Order 14009, ‘‘Strengthening Medicaid and the Affordable Care Act’’ (E.O. 14009).58 Section 3 of E.O. 14009 directs HHS, and the heads of all other executive departments and agencies with authorities and responsibilities related to Medicaid and the ACA, to review all existing regulations, orders, guidance documents, policies, and any other similar agency actions to determine whether they are inconsistent with policy priorities described in section 1 of E.O. 14009, to include protecting and strengthening the ACA and making high-quality health care accessible and affordable for all individuals.59 The ACA is fundamentally ‘‘designed to broaden access to healthcare and insurance coverage.’’ 60 Further, the Women’s Health Amendment was designed to expand access to the preventive care and screenings that 51 Ranji, U., Salganicoff, A., Sobel, L., & Gomez, I. (2017). Financing family planning services for low-income women: The role of public programs. The Henry J. Kaiser Family Foundation. https:// www.kff.org/wp-content/uploads/2019/10/IssueBrief-Financing-Family-Planning-Services-for-Lowincome-Women-1.pdf 52 Sawhill, I. & Guyot, K. (2019). ‘‘Preventing unplanned pregnancy: Lessons from the states.’’ Brookings. https://www.brookings.edu/research/ preventing-unplanned-pregnancy-lessons-from-thestates/. 53 Finer, L. & Zolna, M. (2016). ‘‘Declines in Unintended Pregnancy in the United States, 2008– 2011.’’ N Engl J Med, 374(9):843–52 and Behn, M., Pace, LE. et al.(2019). ‘‘The Trump Administration’s Final Regulations Limit Insurance Coverage of Contraception.’’ Women’s Health Issues, 29(2): 103– 106. 54 Payne, C., & Fanarjian, N. (2014). Seeking causes for race-related disparities in contraceptive use. Virtual Mentor, 16(10), 805–809. https:// doi.org/10.1001/virtualmentor.2014.16.10.jdsc11410. 55 Sutton, M. Y., Anachebe, N. F. & Skanes H. (2021). ‘‘Racial and Ethnic Disparities in Reproductive Health Services and Outcomes, 2020.’’ Obstetrics and gynecology, 137(2), 225–233. https://doi.org/10.1097/AOG.0000000000004224. 56 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. 57 See Bernstein, Anna and Kelly M. Jones (2019). ‘‘The Economic Effects of Contraceptive Access: A Review of the Evidence.’’ Institute for Women’s Policy Research. Available at https://iwpr.org/wpcontent/uploads/2020/07/B381_ContraceptionAccess_Final.pdf. 58 86 FR 7793 (February 2, 2021). 59 E.O. 14009 also revoked Executive Order 13765 of January 20, 2017 (Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal). The Departments adopted the moral exemption and accommodation in part to further this now revoked Executive Order by relieving a regulatory burden imposed on entities with moral convictions opposed to providing certain contraceptive coverage. 60 Religious Sisters of Mercy v. Azar, 513 F. Supp. 3d 1113 (D.N.D. 2021). PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7242 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules women require.61 HHS issued the HRSA-Supported Guidelines pursuant to the Women’s Health Amendment that included contraceptives as a category of preventive services recommended for women. If finalized, these proposed rules would better align the preventive services regulations with the policy priorities described in section 1 of E.O. 14009 by expanding access to contraceptive services without cost sharing to individuals whose health plans currently do not or would not offer such coverage due to a religious or moral objection. Also, on January 28, 2021, President Biden issued a Memorandum on ‘‘Protecting Women’s Health at Home and Abroad.’’ 62 Section 1 of the Memorandum stated ‘‘[w]omen should have access to the healthcare they need. For too many women today, both at home and abroad, that is not possible . . . The Federal Government must take action to ensure that women at home and around the world are able to access complete medical information, including with respect to their reproductive health.’’ These proposed rules would, if finalized, help to support women’s access to reproductive health care services at home. On April 5, 2022, President Biden issued Executive Order 14070, ‘‘Continuing to Strengthen Americans’ Access to Affordable, Quality Health Coverage’’ (E.O. 14070).63 Section 2 of E.O. 14070 requires the heads of appropriate agencies to, in addition to taking the actions directed pursuant to E.O. 14009, take several other actions, including examine policies or practices that make it easier for all consumers to enroll in and retain coverage, understand their coverage options, and select appropriate coverage; that strengthen benefits and improve access to health care providers; that improve the comprehensiveness of coverage and protect consumers from low-quality coverage; that expand eligibility and lower costs for coverage in the ACA Exchanges, Medicaid, Medicare, and other programs; that help improve linkages between the health care system and other stakeholders to address health-related needs; and that help reduce the burden of medical debt on 61 To implement the Women’s Health Amendment, HRSA commissioned the independent Institute of Medicine, now known as the National Academy of Medicine, to conduct a scientific review and provide recommendations on specific preventive measures that meet women’s health needs. 62 86 FR 33077. 63 87 FR 20689. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 households. These proposed rules would further the goals of E.O. 14070. On July 8, 2022, President Biden issued Executive Order 14076, ‘‘Protecting Access to Reproductive Healthcare Services (E.O. 14076).’’ 64 Section 3 of E.O. 14076 requires the Secretary of HHS to submit a report to the President identifying potential actions to ‘‘protect and expand access to the full range of reproductive healthcare services, including actions to enhance family planning services such as access to emergency contraception’’ and ‘‘identifying ways to increase outreach and education about access to reproductive healthcare services, including by launching a public awareness initiative to provide timely and accurate information about such access, which shall include promoting awareness of and access to the full range of contraceptive services.’’ These proposed rules would take critical steps to further the goals in E.O. 14076 by expanding access to the full range of contraceptive services for women enrolled in coverage established or maintained by an objecting entity, or in health insurance coverage offered or arranged by an objecting entity. In addition to addressing the directives in the Executive Orders discussed above, these proposed rules also address the concerns about limiting access to contraception that have been raised by litigants. The Supreme Court remanded the Little Sisters cases to the U.S. Courts of Appeals for the Third and Ninth Circuits, respectively, to consider whether the November 2018 final rules adequately considered women’s health and access to contraceptives or were arbitrary and capricious. Under the current exemptions, objectors are not required to inform participants, beneficiaries, or enrollees that the plan or coverage does not cover contraceptive services or invoke the optional accommodation, and no alternative mechanisms provide contraceptive coverage for affected women—leaving many women without coverage.65 Given that the November 2018 final rules allow, but do not require, objecting entities to invoke the accommodation process, many women in plans subject to an exemption may be unable to access contraceptive services due to 64 87 FR 42053. 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. 65 In PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 financial, logistical, or administrative barriers. These proposed rules seek to ensure that women who are enrolled in either a group health plan established or maintained by an objecting entity, or in health insurance coverage offered or arranged by an objecting entity, including an employer, institution of higher education, or health insurance issuer, have access to cost-free contraceptive coverage, even when the objecting entity claims the regulatory exemption without voluntarily using the accommodation process. This proposed approach would further the government’s interest in protecting women’s health and their right to make reproductive decisions. In light of these considerations, the Departments are issuing these proposed rules to further the government’s interest in promoting coverage for contraceptive services for all women,66 and in eliminating barriers to access, while respecting the religious objections of employers, health insurance issuers, and institutions of higher education to coverage of contraceptive services. 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 66 See Section VI.B.2. of this preamble, under the Benefits heading. E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules 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 VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 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 religiousobjector entities is available to entities that are institutions of higher education. While these proposed rules would maintain the religious exemption rule, they also would provide an independent pathway through which women enrolled in plans or coverage sponsored, arranged, or provided by objecting entities can access contraceptive services at no cost. With respect to participants and beneficiaries in insured or self-insured group health plans sponsored by an exempt entity, or enrollees in individual health insurance coverage (including student health insurance coverage) arranged or provided by an exempt entity, and that does not invoke the optional accommodation (if eligible), these proposed rules would create a pathway, independent from the employer, group health plan, plan sponsor, or issuer, through which individuals could obtain at no cost from a willing provider of contraceptive services 67 (that meets certain requirements), contraceptive services for which their plan or issuer would otherwise be required to provide coverage absent the religious exemption. These proposed rules refer to this pathway as the individual contraceptive arrangement. This individual contraceptive arrangement would be available to the participant, beneficiary, or enrollee without the plan sponsor or issuer having to take any action that would facilitate the coverage to which it objects. Simply put, the action is undertaken by the individual, for the individual. Through the individual contraceptive arrangement, a provider of contraceptive services, who provides these services at no cost to the women receiving them, would be able to seek reimbursement from an issuer with whom it has a signed agreement for the cost of providing contraceptive services to women covered under these plans. These proposed rules also would amend 45 CFR 156.50(d) so that a qualified health plan (QHP) issuer that has agreed to reimburse an eligible provider of contraceptive services that participates in the individual contraceptive 67 These proposed rules refer to providers, consistent with the proposed definition of the term ‘‘provider of contraceptive services,’’ as including both health care providers and facilities. This definition is discussed later in this preamble. PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 7243 arrangement would be eligible for an adjustment to the issuer’s Federallyfacilitated 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). 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 nonreligious 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 E:\FR\FM\02FEP2.SGM 02FEP2 7244 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 comprehensive guidelines supported by HRSA for purposes of section 2713(a)(4) of the PHS Act. The currently applicable 68 HRSA-Supported Guidelines, as updated on December 17, 2019, include a guideline that adolescent and adult women have access to the full range of femalecontrolled FDA-approved contraceptive methods,69 effective family planning practices, and sterilization procedures to prevent unintended pregnancy and improve birth outcomes.70 The currently applicable HRSA-Supported Guidelines state that contraceptive care should include contraceptive counseling, initiation of contraceptive use, and follow-up care (for example, management and evaluation as well as changes to, and removal or discontinuation of, the contraceptive method), and that instruction in fertility awareness-based methods, including the lactation amenorrhea method, should be provided for women desiring an alternative method. The Departments have clarified in guidance the obligation of a plan or issuer to provide coverage of contraceptive services in accordance with these HRSA-Supported Guidelines. On February 20, 2013, the Departments issued FAQs about Affordable Care Act Implementation Part XII (FAQs Part XII) stating that the HRSA-Supported Guidelines ensure women’s access to the full range of FDA-approved contraceptive methods 71 including, but not limited to, barrier methods, hormonal methods, and implanted devices, as well as patient education and counseling, as prescribed by a health care provider.72 The FAQs further clarified that plans and issuers may use reasonable medical management techniques to control costs and promote efficient delivery of care, such as covering a generic drug without cost sharing and imposing cost sharing for equivalent branded drugs. However, FAQs Part XII stated that, in these 68 As explained in FN 4, in December 2021, HRSA approved updates to the contraception guidelines that apply to plan years (in the individual market, policy years) starting on and after December 30, 2022. See changes at https://www.hrsa.gov/womensguidelines. 69 The Departments note that the FDA approves, clears, and grants contraceptive products and not methods. 70 See https://www.hrsa.gov/womens-guidelines2019. 71 The FDA does not and never has approved, granted, or cleared contraceptive methods, only contraceptive products. See FN 4, supra. 72 See Q14, available at 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-andFAQs/aca_implementation_faqs12.html. See also FN 61. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 instances, a plan or issuer must accommodate any individual for whom a particular drug (generic or brand name) would be medically inappropriate, as determined by the individual’s health care provider, by having a mechanism for waiving the otherwise applicable cost sharing for the brand or non-preferred brand version. The FAQs also clarified that contraceptive products that are generally available over-the-counter are required to be covered only if they are both FDA-approved, cleared, or granted and prescribed by a health care provider.73 On May 11, 2015, the Departments issued FAQs about Affordable Care Act Implementation Part XXVI (FAQs Part XXVI) clarifying that plans and issuers must cover, without cost sharing, at least one form of contraception in each category that is identified by the FDA in its Birth Control Guide.74 The FAQs further clarified that, to the extent plans and issuers use reasonable medical management techniques within a 73 Id. at Q15. Q2 and Q3, available at https:// www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/ our-activities/resource-center/faqs/aca-partxxvi.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 HRSASupported Guidelines do not include male sterilization. See https://www.hrsa.gov/womensguidelines. See also Preamble to Final Rules regarding coverage of certain preventive services at 78 FR 39870 (July 2, 2013). 74 See PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 specified category of contraception, plans and issuers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or provider (or other individual acting as a patient’s authorized representative) to ensure coverage without cost sharing of any service or FDA-approved item within the specified category of contraception. FAQs Part XXVI stated that if an individual’s attending provider recommends a particular service or FDA-approved item based on a determination of medical necessity with respect to that individual, the plan or issuer must cover that service or item without cost sharing. The FAQs made clear that a plan or issuer must defer to the determination of the attending provider. FAQs Part XXVI stated that medical necessity may include considerations such as severity of side effects, differences in permanence and reversibility of contraceptives, and ability to adhere to the appropriate use of the item or service, as determined by the attending provider. The FAQs also clarified that the exceptions process must provide for making a determination of the claim according to a timeframe and in a manner that takes into account the nature of the claim (for example, pre-service or post-service) and the medical exigencies involved for a claim involving urgent care. FAQs Part XXVI additionally clarified that a plan or issuer cannot limit sex-specific recommended preventive services based on an individual’s sex assigned at birth, gender identity, or recorded gender.75 On April 20, 2016, the Departments issued FAQs about Affordable Care Act Implementation Part 31, Mental Health Parity Act Implementation, and Women’s Health and Cancer Rights Act Implementation (FAQs Part 31) stating that if a plan or issuer utilizes reasonable medical management techniques within a specified method of contraception, the plan or issuer may develop and utilize a standard exception form and instructions as part of its steps to ensure that it provides an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individual acting as a patient’s authorized representative).76 The FAQs suggested that the Medicare Part D Coverage Determination Request Form may serve as a model for plans and 75 Id. at Q5. Q2, available at https://www.dol.gov/sites/ dolgov/files/EBSA/about-ebsa/our-activities/ resource-center/faqs/aca-part-31.pdf and https:// www.cms.gov/CCIIO/Resources/Fact-Sheets-andFAQs/Downloads/FAQs-31_Final-4-20-16.pdf. 76 See E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 issuers when developing a standard exception form.77 On January 10, 2022, the Departments issued FAQs about Affordable Care Act Implementation Part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act Implementation (FAQs Part 51) that reiterated previously issued guidance related to coverage of contraceptive services and provided examples of practices reported to the Departments that denied contraceptive coverage to participants, beneficiaries, and enrollees.78 The FAQ also clarified that if an individual’s attending provider determines that a particular service or FDA-approved, cleared, or granted contraceptive product is medically appropriate for such individual, a plan or issuer must cover that service or product without cost sharing, whether or not the service or product is in a category of contraception specifically identified in the current HRSA-Supported Guidelines. On July 28, 2022, the Departments issued FAQs about Affordable Care Act Implementation Part 54 (FAQs Part 54) on additional aspects of contraceptive coverage, reiterating and clarifying the types of items and services required to be covered under PHS Act section 2713 and its implementing regulations. Specifically, these FAQs explained that plans and issuers are required to cover, without any cost sharing, items and services that are integral to the furnishing of a recommended preventive service, such as anesthesia necessary for a tubal ligation procedure or pregnancy tests needed before provision of certain forms of contraceptives, such as an intrauterine device (also known as an IUD), regardless of whether the item or service is billed separately.79 FAQs Part 54 also addressed contraceptive products and services that are not included in a category of contraception described in the HRSA-Supported Guidelines, reiterating that plans and issuers must cover any contraceptive services and FDA-approved, cleared, or granted contraceptive products that an individual and their attending provider 77 A copy of the Medicare Part D Coverage Determination Request Form is available at https:// www.cms.gov/Medicare/Appeals-and-Grievances/ MedPrescriptDrugApplGriev/ CoverageDeterminations-. 78 See Q9, 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-andFAQs/Downloads/FAQs-Part-51.pdf. 79 See Q1, available at https://www.dol.gov/sites/ dolgov/files/EBSA/about-ebsa/our-activities/ resource-center/faqs/aca-part-54.pdf and at https:// www.cms.gov/files/document/faqs-part-54.pdf. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 have determined to be medically appropriate for the individual, whether or not those services or products are specifically identified in the categories listed in the HRSA-Supported Guidelines.80 Additionally, the FAQs reiterated the requirement to cover FDAapproved emergency contraception, including emergency contraception that is available over-the-counter (OTC), when prescribed, and encouraged plans and issuers to cover OTC emergency contraceptive products with no cost sharing when purchased without a prescription. The FAQs also state that a health savings account, health flexible spending arrangement, or health reimbursement arrangement can reimburse expenses incurred for OTC contraception obtained without a prescription.81 Further, the FAQs addressed instruction in fertility awareness-based methods and encouraged plans and issuers to cover the dispensing of a 12-month supply of contraception without cost sharing.82 FAQs Part 54 also addressed the use of reasonable medical management techniques as applied to contraceptive products or services, including explaining that plans and issuers may use reasonable medical management techniques for contraceptive products or services not included in the categories described in the HRSA-Supported Guidelines only if multiple, substantially similar services or products that are not included in a category are available and are medically appropriate for an individual.83 For contraceptive products or services included in the categories described in the HRSA-Supported Guidelines, the FAQs reiterate that plans and issuers may utilize reasonable medical management techniques only within a specified category of contraception and only to the extent the HRSA-Supported Guidelines do not specify the frequency, method, treatment, or setting for the provision of a recommended preventive service that is a contraceptive service or FDA-approved, cleared, or granted product.84 The FAQs offered guidance on how to determine whether a medical management technique is reasonable for purposes of the requirements under PHS Act section 2713, including examples of unreasonable medical management techniques, such as imposing an age limit on contraceptive coverage instead of providing these benefits to all individuals with reproductive 7245 capacity.85 In addition, FAQs Part 54 offered guidance on what constitutes an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or their provider and explained that the Departments will consider an exceptions process to be easily accessible if plan documentation includes relevant information regarding the exceptions process under the plan or coverage, including how to access the exceptions process without initiating an appeal pursuant to the plan’s or issuer’s internal claims and appeals procedures, the types of information the plan or issuer requires as part of a request for an exception, and contact information for a representative of the plan or issuer who can answer questions related to the exceptions process.86 The FAQs state that a plan or issuer may not require a participant, beneficiary, or enrollee to appeal an adverse benefit determination using the plan or issuer’s internal claims and appeals process as the means for an individual to obtain an exception.87 As explained in FAQs Part 51 and FAQs Part 54, the Departments have received a number of complaints and reports regarding potential violations of the contraceptive coverage requirement. The Departments are committed to ensuring consumers have access to the contraceptive benefits, without cost sharing, that they are entitled to under the ACA and implementing regulations. In addition to previously issued clarifications, the Departments are continuing to assess what changes to existing regulations or guidance may be needed to better ensure individuals receive the coverage to which they are entitled under the law and will issue additional guidance, as warranted. The Departments solicit comments regarding whether any other clarifications or additional guidance is needed in these proposed rules to help ensure that women covered under group health plans or health insurance coverage have access to contraceptive services at no cost. Moreover, stakeholders who have information regarding potential noncompliance with these requirements should contact the Departments as the Departments continue to consider what additional oversight and enforcement actions could be taken to ensure health plans and issuers are complying with the contraceptive benefits guaranteed under the ACA.88 85 Id. 80 Id. at Q2. 81 Id. at Q5 and Q6. 82 Id. at Q4 and Q7. 83 Id. at Q3. 84 Id. at Q8. PO 00000 Frm 00011 Fmt 4701 86 Id. at Q9. at Q10. 88 As stated in FAQs Part 54, Q14, consumers who have fully-insured coverage and who have 87 Id. Continued Sfmt 4702 E:\FR\FM\02FEP2.SGM 02FEP2 7246 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules However, these proposed rules would not alter these coverage standards applicable to contraceptive services. Rather, these proposed rules focus on the religious and moral objections of entities otherwise subject to those coverage standards, and participants’, beneficiaries’, and enrollees’ access to contraceptive services without cost sharing when their plan or coverage excludes coverage for these services based on religious objections and does not adopt the existing optional accommodation. No new Federal processes, resources, data systems, or reporting mechanisms are anticipated for monitoring and tracking entities’ objections, or the identities of entities availing themselves of these exemptions. Therefore, the Departments propose only minor changes to 26 CFR 54.9815–2713, 29 CFR 2590.715–2713, and 45 CFR 147.130. 2. Addition of the Phrase ‘‘EvidenceInformed’’ khammond on DSKJM1Z7X2PROD with PROPOSALS2 The Departments propose to add the phrase ‘‘evidence-informed’’ immediately before ‘‘comprehensive’’ in 26 CFR 54.9815–2713(a)(1)(iv), 29 CFR 2590.715–2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), so that the reference in the paragraph would be to evidenceinformed comprehensive guidelines supported by HRSA. Section 2713(a) of the PHS Act specifies that the preventive services that must be covered without cost sharing are: (1) evidence-based items or services that have in effect a rating of ‘‘A’’ or ‘‘B’’ in the current recommendations of the United States Preventive Services Task Force (USPSTF) with respect to the individual involved; (2) immunizations that have in effect a recommendation from the Advisory Committee on Immunization Practices of the CDC with respect to the individual involved; (3) with respect to infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the concerns about their health insurance issuer’s compliance with these requirements may contact their State Department of Insurance (for more information, visit https://content.naic.org/state_ web_map.htm). Consumers who are covered by a private-sector, employer-sponsored group health plan and have concerns about their plan’s compliance with these requirements may contact the Department of Labor at https://www.dol.gov/ agencies/ebsa/about-ebsa/ask-a-question/ask-ebsa or by calling toll free at 1–866–444–3272. Consumers who are covered by a non-Federal public-sector employer-sponsored plan (such as a State or local government employee plan) and have concerns about their plan’s compliance with these requirements may contact the Center for Consumer Information and Insurance Oversight at (888) 393– 2789 or contraception_complaints@cms.hhs.gov for further assistance with a question or issue. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 comprehensive guidelines supported by HRSA; and (4) with respect to women, such additional preventive care and screenings not described in the aforementioned recommendations by USPSTF as provided for in comprehensive guidelines supported by HRSA for purposes of section 2713(a)(4) of the PHS Act.89 The reference to ‘‘evidence-informed’’ preventive care and screenings in comprehensive HRSA-Supported Guidelines was removed in the October 2017 Religious Exemption interim final rules to align with the statutory text.90 However, because the statute requires that the USPSTF recommendations relate to ‘‘evidence-based’’ items and services, and because the statute also requires that HRSA’s guidelines for infants, children, and adolescents be ‘‘evidenceinformed,’’ the Departments are of the view that it is consistent with the general purpose of section 2713 of the PHS Act that, with respect to women, the additional preventive care and screenings provided for in comprehensive guidelines supported by HRSA be evidence-informed.91 Furthermore, the Departments recognize that section 2713 of the PHS Act establishes special coverage requirements for certain services that have been shown by evidence to have benefits as preventive services.92 Most studies suggest that removing cost89 In addition, under section 3203 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act and its implementing regulations, plans and issuers must cover, without cost-sharing requirements, any qualifying coronavirus preventive service pursuant to section 2713(a) of the PHS Act and its implementing regulations (or any successor regulations). The term ‘‘qualifying coronavirus preventive service’’ means an item, service, or immunization that is intended to prevent or mitigate coronavirus disease 2019 (COVID–19) and that is, with respect to the individual involved (1) an evidence-based item or service that has in effect a rating of ‘‘A’’ or ‘‘B’’ in the current USPSTF recommendations; or (2) an immunization that has in effect a recommendation from ACIP (regardless of whether the immunization is recommended for routine use). On November 6, 2020, the Departments published interim final rules with a request for comment regarding this requirement, Additional Policy and Regulatory Revisions in Response to the COVID–19 Public Health Emergency (85 FR 71142). 90 The explanation for why the reference to ‘‘evidence-informed’’ was removed, that is, to align with the statutory text, was provided in the November 2018 Religious Exemption final rules. See 83 FR 57536, 57557 (November 15, 2018). 91 The Departments interpret ‘‘evidence-based’’ to require that the standards be based solely on scientific ‘‘evidence,’’ while, as discussed later in this preamble, ‘‘evidence-informed’’ means that they are informed by a consideration of scientific evidence, but such evidence need not be the only basis for its standards. As the Court held in Little Sisters, HRSA is also authorized to consider the propriety of including exemptions based upon religious or moral objections. 140 S. Ct. at 2381. 92 See section 2713(a)(1) and (3) of the PHS Act. PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 sharing barriers to these items and services helps to increase access and utilization by participants, beneficiaries, and enrollees who might otherwise delay or skip care due to financial barriers.93 However, coverage, without cost sharing, of recommended preventive items and services and the resulting increases in utilization can increase costs to consumers in the form of increased premiums, unless those costs are offset by savings. By reinstating the requirement that the HRSA-Supported Guidelines be evidence-informed, these proposed rules would help ensure that plans and issuers are required to cover recommended preventive items and services, without cost sharing, only when evidence supports the items’ or services’ value as preventive care. Thus, this proposed amendment would help to limit overutilization of services and promote efficiencies in care delivery while ensuring that participants, beneficiaries, and enrollees have access to critical women’s preventive services. Additionally, this proposed change would better reflect current practice. HRSA’s process for developing clinical guidelines for women’s preventive services is, and has historically been, evidence-based. In establishing the HRSA-Supported Guidelines, HHS, acting through HRSA, depends on the work of the Women’s Preventive Services Initiative (WPSI). According to WPSI, its recommendations are intended to guide clinical practice and coverage of services for HRSA and other stakeholders.94 The recommendation development process of the WPSI is based on adaptation of the eight criteria for evidence-based clinical practice guideline development as articulated in the 2011 report, Clinical Practice Guidelines We Can Trust from the National Academy of Medicine (formerly the Institute of Medicine [IOM]).95 The WPSI clinical recommendations are based on reaching a threshold of supportive evidence, similar to the 2011 IOM Panel.96 The WPSI bases recommendations on evidence of both benefits and harms of an intervention or service and an assessment of the balance between 93 Norris, HCH. C., Richardson, HM., et al. (2021). ‘‘H. M., Benoit, M. C., Shrosbree, B., Smith, J. E., & Fendrick, A. M. (2022). Utilization Impact of Cost-Sharing Elimination for Preventive Care Services: A Rapid Review.’’ Medical Care Research and Review. Available at, 79(2), 175–197. https:// journals.sagepub.com/doi/pdf.org/10.1177/ 10775587211027372. 94 See WPSI’s Methodology Summary at https:// www.womenspreventivehealth.org/wp-content/ uploads/WPSI-Methodology-1.pdf. 95 Id. 96 Id. E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules them.97 As part of the WPSI process, an evidence report on an approved topic is presented to its multidisciplinary steering committee (MSC), and is used as the basis for recommendation development.98 The MSC is then asked to consider the evidence in depth and to formulate a recommendation.99 Recommendations, which include this evidence review, that are approved by 75 percent of the MSC are submitted to HRSA by December 1 of the given calendar year.100 If approved by HHS, acting through the HRSA Administrator, the WPSI Clinical Recommendation is added to the HRSA-Supported Guidelines.101 Thus, HRSA-Supported Guidelines, as currently developed, are evidence-informed. The proposed addition of the term ‘‘evidenceinformed’’ in 26 CFR 54.9815– 2713(a)(1)(iv), 29 CFR 2590.715– 2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv) would more precisely describe the process through which the HRSA-Supported Guidelines are established and ensure the Guidelines continue to be evidence-informed in the future. For these reasons, the Departments propose to codify that standard. The Departments do not anticipate that this proposed amendment would alter the existing processes through which the HRSA-Supported Guidelines are developed, as these processes, as stated previously, already include a robust consideration of evidence. The Departments seek comment on this proposal. khammond on DSKJM1Z7X2PROD with PROPOSALS2 3. Conforming Edits As discussed in section II.C.2 of this preamble, the Departments also propose to eliminate the exemption for entities with moral objections to contraceptive coverage at 45 CFR 147.133, and therefore to also make conforming edits to remove references to 45 CFR 147.133 that appear in paragraph (a)(1) of 45 CFR 147.130 and paragraph (a)(1)(iv) of 26 CFR 54.9815–2713, 29 CFR 2590.715–2713 and 45 CFR 147.130. Finally, HHS proposes to remove from 45 CFR 147.130(a)(1) references to 45 CFR 147.131 and 45 CFR 147.132. Those references also appear in paragraph (a)(1)(iv), for the same purpose, and therefore are duplicative and unnecessary in 45 CFR 147.130(a)(1). 97 Id. 98 Id. 99 Id. 100 Id. 101 Id. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 C. Exemptions in Connection With Coverage of Contraceptive Services (45 CFR 147.132 and 147.133) 1. Religious Exemptions This proposed rule would maintain the religious exemption from the November 2018 Religious Exemption final rules. Each of the proposed changes made to the regulations with respect to religious objections is either technical in nature or codifies the intent specified in the preamble to the November 2018 Religious Exemption final rules. The proposed changes in no way narrow the scope of the exemption or further restrict the types of religious entities that may use the exemption. Under the regulations at 26 CFR 54.9815–2713(a)(1)(iv), 29 CFR 2590.715–2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), a non-grandfathered group health plan, or a health insurance issuer offering non-grandfathered group or individual health insurance coverage, must provide coverage for, and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for, with respect to women, such additional preventive care and screenings as provided for in comprehensive guidelines supported by HRSA, subject to the exemptions and accommodations related to contraceptive coverage. The November 2018 Religious Exemption final rules at 45 CFR 147.132(a)(1) state that guidelines issued under 45 CFR 147.130(a)(1)(iv) by HRSA must not provide for or support the requirement of coverage or payments for contraceptive services with respect to a group health plan established or maintained by an objecting entity, to the extent of the objections specified in the regulations. The Departments note that the regulations require HRSA to include an exemption in its guidelines. Although the Supreme Court held in Little Sisters that the ACA ‘‘gives HRSA broad discretion to define preventive care and screenings and to create the religious and moral exemptions,’’ it also concluded that ‘‘the plain language of the statute clearly allows the Departments to create the preventive care standards as well as the religious and moral exemptions’’ 102 103 (emphasis 102 Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania, 140 S. Ct. 2367, 2382 (2020); see also id. at 2374–75, 2377–78 (recounting the Departments’ history of deciding what should be included in the HRSA-Supported Guidelines). 103 Exempting the types of objecting entities listed in the November 2018 final rules from any guideline requirements that relate to the provision of contraceptive services is consistent with the Departments’ proposed requirement (discussed in section II.B of this preamble) that the PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 7247 added). This is understandable because the HRSA Administrator exercises authority delegated from and subject to the control of the Secretary of HHS.104 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 nongovernmental 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 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. E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7248 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules is not an objecting entity or objecting individual. The preamble to the November 2018 final rules specified this prohibition with respect to exempt entities,105 but the provision was not included in the regulatory text. This prohibition would apply to all health insurance issuers, whether or not the issuer is an exempt or non-exempt entity. The Departments have identified no reason to treat exempt and nonexempt 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. 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 HRSASupported 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 105 83 FR 57536, 57565. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 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 PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 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 E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules 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. khammond on DSKJM1Z7X2PROD with PROPOSALS2 2. Moral Exemptions Under 45 CFR 147.133, the HRSASupported 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 nonreligious 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 106 83 FR 57592, 57598. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 individuals.107 In Little Sisters, the Supreme Court concluded that it was appropriate for HRSA to consider the prevalence of RFRA claims, and the possibility of required exemptions under RFRA, as a reason for establishing the religious exemption.108 The Departments have done so, and these proposed rules continue to provide exemptions for religious organizations, employers and institutions of higher education, and health insurance issuers with sincerely held religious objections to providing, sponsoring, or arranging coverage of contraceptive services. 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 In considering whether to propose removing the moral exemption, the Departments considered past litigation and settlements related to non-religious moral objections to the requirement that plans and issuers provide coverage of certain preventive services. The Departments are aware that one entity, March for Life, has obtained a permanent injunction preventing the enforcement of the contraceptive coverage requirement against it because of its non-religious moral objections. The District Court for the District of Columbia in that case reasoned that there was no rational basis for the Departments to distinguish between religious and moral objections.110 The Departments respectfully disagree with 107 83 FR 57592, 57627. The November 2018 Moral Exemption final rules assumed that nine nonprofit entities and nine for-profit entities would avail themselves of the moral exemption, and estimated that approximately 15 women may incur contraceptive costs due to use of the moral exemption by for-profit entities. 108 Little Sisters of the Poor Saints Peter and Paul Home v. Pennsylvania, 140 S. Ct. 2367 (2020). 109 Corporation of Presiding Bishop of Jesus Christ of Latter-Day Saints v. Amos, 483 U.S. 327, 339, 107 S. Ct. 2862 (1987). 110 March for Life v. Burwell, 128 F. Supp. 3d 116 (D.D.C. 2015). PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 7249 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 nonreligious moral exemption, because there is no moral-exemption statute similar to RFRA. The Departments are of the view that few entities make use of the moral exemption at this time. In the November 2018 Moral Exemption final rules, without data available to estimate the actual number of entities that would make use of the exemption for entities with sincere moral objections, the Departments assumed that the moral exemption would be used by nine nonprofit entities and nine for-profit entities.111 These assumptions were made in the absence of data. Thus, the Departments seek comment on how many women lost contraceptive coverage without cost sharing based on the moral exemption rule, and how many would regain access to such coverage by rescinding the availability of the moral exemption. The Departments seek evidence of the quantitative harms from the moral exemption rule. The Departments note, however, that eliminating the moral exemption is likely justified even if more entities than previously estimated make use of the moral exemption. In the November 2018 Moral Exemption final rules, the Departments noted that the organizations that have sued seeking a moral exemption have adopted longstanding moral tenets opposed to certain FDA-approved contraceptives and hire only employees who share this view. Commenters on the October 2017 Moral Exemption interim final rules made similar points and also suggested that therefore requiring coverage of contraceptive services by a group health plan or coverage sponsored, arranged, or provided by an objecting entity subject to a moral exemption would yield no benefits, because that entity’s employees would neither want nor use contraception. At the time, the Departments concluded that employees of these organizations would not benefit from the requirement to provide contraceptive services coverage.112 Yet, although employees of these organizations may typically share the views of the organizations, it is not necessarily true that all employees of these organizations share all of these 111 83 112 83 E:\FR\FM\02FEP2.SGM FR 57592, 57625 (November 15, 2018). FR 57536, 57602. 02FEP2 7250 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 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. In the preamble to the November 2018 Moral Exemption final rules, the Departments referred to a number of Federal statutes demonstrating Congress’ historical desire and intent to protect non-religious moral objections to abortion and other activities. For example, the Departments referred at length to the Church Amendments. The preamble to the November 2018 Moral Exemption final rules stated: The Church Amendments specifically provide conscience protections based on sincerely held moral convictions, not just religious beliefs. Among other things, the amendments protect the recipients of certain federal health funds [under the Public Health Service Act (42 U.S.C.A. 201 et seq.), the Community Mental Health Centers Act (42 U.S.C.A. 2689 et seq.), the Developmental Disabilities Assistance, or the Bill of Rights Act of 2000 (42 U.S.C.A. 15001 et seq.)] from being required to perform, assist, or make their facilities available for abortions or sterilizations if they object ‘on the basis of religious beliefs or moral convictions,’ and they prohibit recipients of certain federal health funds from discriminating against any personnel ‘because he refused to perform or assist in the performance of such a procedure or abortion on the grounds that his performance or assistance in the performance of the procedure or abortion would be contrary to his religious beliefs or moral convictions.’ Later additions to the Church Amendments protect other conscientious objections, including some objections on the basis of moral conviction to ‘any lawful health service,’ or to ‘any part of a health service program.’ In contexts covered by those sections of the Church Amendments, the provision or coverage of certain contraceptives, depending on the circumstances, could constitute ‘any lawful health service’ or a ‘part of a health service program.’ 113 113 83 FR 57592, 57599 (internal citations removed). VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 However, the Departments now find it significant that Congress chose not to apply those statutory provisions to private entities that typically do not accept funds from or do business with the government, that is, entities that are, in that respect, similar to sponsors of private group health plans.114 The Departments also note that the Church Amendments primarily address the imposition of employment responsibilities or personal service requirements that would infringe upon an individual’s moral beliefs, which is not directly relevant to an employer’s, college’s or university’s, or health insurance issuer’s moral objections to contraceptive coverage. The Departments also find it significant that those statutory provisions were enacted before the Supreme Court’s opinion in Dobbs. Given that decision and the consequent threat to women’s access to abortion and their ability to exercise control over their reproductive health care decisions, it is now all the more critical that women have access to contraceptive coverage. In fact, the Departments noted in the November 2018 Moral Exemption final rules that ‘‘[t]he Church Amendments were enacted in the wake of the Supreme Court’s decision in Roe v. Wade.’’ 115 At that time, Congress was acting in an environment in which there were, or were about to be, fewer restrictions on reproductive health. 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 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. PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 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 E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules 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. D. Alternate Availability of Certain Preventive Health Services (26 CFR 54.9815–2713A, 29 CFR 2590.715– 2713A, and 45 CFR 147.131) khammond on DSKJM1Z7X2PROD with PROPOSALS2 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 nonreligious 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. In the same paragraph, the Departments propose to add a crossreference 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 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). 117 In 45 CFR 147.131, these proposed rules would eliminate reserved paragraphs (a) and (b), and redesignate paragraph (c) as paragraph (a). VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 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. 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 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.’’) PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 7251 2590.715–2713A(c)(2)(ii), and redesignated 45 CFR 147.131(b)(2)(ii). The current cross-reference establishes that, when an insured group health plan avails itself of the optional accommodation, its health insurance issuer must provide separate payments for contraceptive services in a manner that is consistent with, among others, the patient protection requirements under section 2719A of the PHS Act. Section 2719A of the PHS Act provided that if a plan or issuer requires or provides for designation by a participant, beneficiary, or enrollee of a participating primary care provider, individuals may designate any participating primary care providers available to accept them, including pediatricians, and prohibits the plan or issuer from requiring authorization or referral for obstetrical or gynecological care. Section 102 of title I of Division BB of the Consolidated Appropriations Act, 2021 (CAA) 119 amended section 2719A of the PHS Act to include a sunset provision effective for plan years beginning on or after January 1, 2022, when the new protections under the No Surprises Act took effect. Additionally, the No Surprises Act recodified the patient protections regarding choice of health care professional from section 2719A(a), (c), and (d) of the PHS Act at new section 9822 of the Code, section 722 of ERISA, and section 2799A–7 of the PHS Act.120 The Departments are of the view that it would be appropriate to continue to require that, when making separate payments for contraceptive services through the optional accommodation for insured plans, an issuer must make those payments in a manner that is consistent with these patient protections. The Departments seek comment on the circumstances under which contraceptive services would constitute emergency services,121 as well as whether to continue to apply the protections for emergency services, which were set forth under section 2719A of the PHS Act, and subsequent to that provision sunsetting, are now set 119 Title I of Division BB of the CAA is also known as the No Surprises Act. 120 Section 2719A(b) of the PHS Act and the Departments’ implementing regulations established requirements applicable to group health plans and health insurance issuers offering group or individual health insurance related to the coverage of emergency services, which are also covered under the CAA’s sunset provision. The No Surprises Act added section 9816 of the Code, section 716 of ERISA, and section 2799A–1 of the PHS Act, which expand the patient protections related to emergency services under section 2719A of the PHS Act, in part, by providing additional consumer protections related to balance billing. 121 The term emergency services is defined in regulations at 26 CFR 54.9816–4T(c)(2), 29 CFR 2590.716–4(c)(2), and 45 CFR 149.110(c)(2). E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7252 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules 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. 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 VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 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 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 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 thirdparty administrators (TPAs) that have provided contraceptive coverage on behalf of an eligible employer. 86 FR 24140, 24229 (May 5, 2021). PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 women enrolled in a health plan established or maintained or arranged by an objecting entity with an alternative mechanism for obtaining contraceptive services with no cost sharing if the entity did not choose to use the accommodation. Additionally, the November 2018 final rules did not require objecting entities or their health plans to notify eligible individuals that the coverage offered excludes contraceptive services. The Departments have determined that it is necessary to provide these women with an alternative pathway to obtaining contraceptive services at no cost (other than the premium or contribution paid for health coverage) because of the public health interest in ensuring women’s access to reproductive health care and contraceptive services without cost sharing, particularly in light of the Supreme Court’s opinion in Dobbs v. Jackson Women’s Health Organization. Specifically, the Departments propose to amend 26 CFR 54.9815–2713A, 29 CFR 2590.715–2713A, and 45 CFR 147.131 to create an individual contraceptive arrangement for women enrolled in a group health plan or health insurance coverage sponsored, offered, or arranged by an objecting entity that does not provide contraceptive coverage and that elects not to use the existing optional accommodations with respect to some or all contraceptive services. By enabling individuals to directly receive contraceptive services at no cost, this proposal would provide them with access to all contraceptive services the plan or coverage would otherwise be required to cover, absent the exemption. Critically, this would be accomplished independent of any action by the objecting entity, which would not be required to take any steps to facilitate this provision of contraceptive services. Under these proposed rules, an eligible individual may voluntarily, and independent of any actions by the objecting entity, elect this individual contraceptive arrangement. Under proposed 26 CFR 54.9815–2713A(e), 29 CFR 2590.715–2713A(e), and 45 CFR 147.131(d), a provider of contraceptive services would furnish contraceptive services to the eligible individual without imposing any fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof.123 The provider of 123 Under these proposed rules, the provider of contraceptive services would furnish contraceptive services to the eligible individual in a manner that is totally independent of any costs that are associated with a group health plan or health insurance coverage sponsored, arranged, or provided by an objecting entity. The Departments E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 contraceptive services would be permitted to seek reimbursement from a participating issuer as defined under 45 CFR 156.50,124 with which the provider has a signed agreement for the costs of providing these contraceptive services. The Departments expect that administrative costs incurred by participating providers of contraceptive services would be included in the amounts they submit to issuers for reimbursement. The issuer in turn would be able to receive a reduction equal to this amount (plus an administrative allowance for costs and margin) to the issuer’s FFE or SBE–FP user fees pursuant to 45 CFR 156.50(d). See section III of this preamble for a discussion of how a provider of contraceptive services would be reimbursed through such an adjustment. Participation in an individual contraceptive arrangement would be entirely voluntary for the provider of contraceptive services. A willing provider of contraceptive services would also be reimbursed for items and services that are integral to the furnishing of the contraceptive service, for an amount agreed to by the provider and eligible issuer, regardless of whether the provider would typically bill for the item or service separately. Reimbursing for the items and services that are integral to the furnishing of the contraceptive service, regardless of whether the provider would typically bill for the item or service separately, is consistent with how the Departments have interpreted section 2713 of the PHS Act as applied to group health plans and health insurance issuers offering group or individual health insurance coverage.125 For purposes of this individual contraceptive arrangement, these note that, because the individual contraceptive arrangement would be completely separate from a plan or coverage sponsored, arranged, or provided by an objecting entity, the provision of the proposed rules that would require a provider of contraceptive services to furnish contraceptive services to eligible individuals without imposing any fee or charge of any kind would mean that the provider of contraceptive services would not collect any amounts that would typically be associated with an eligible individual’s plan or coverage, such as any premiums, cost-sharing requirements, or other similar amounts. 124 45 CFR 156.50 defines participating issuer as any issuer offering a plan that participates in the specific function that is funded by user fees. This term may include: health insurance issuers, QHP issuers, issuers of multi-State plans (as defined in 45 CFR 155.1000(a), issuers of stand-alone dental plans (as described in 45 CFR 155.1065), or other issuers identified by an Exchange. 125 85 FR 71142, 71174. See also FAQs about Affordable Care Act Implementation Part 54 (July 28, 2022), Q1, 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. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 proposed rules would define an eligible individual under 26 CFR 54.9815– 2713A(a)(3), 29 CFR 2590.715– 2713A(a)(3), and 45 CFR 147.131(a)(3) as a participant or beneficiary enrolled in a group health plan established or maintained, or an enrollee in individual health insurance coverage offered or arranged, by an objecting entity described in 45 CFR 147.132(a) that, to the extent eligible, has not invoked the accommodation, and who confirms to a provider of contraceptive services (that agrees to meet certain criteria) that the individual is enrolled in a group health plan or group or individual health insurance coverage sponsored, provided, or arranged by an objecting entity that does not provide coverage for all or a subset of contraceptive services as generally required for non-objecting entities under 26 CFR 54.9815– 2713(a)(1)(iv), 29 CFR 2590.715– 2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv). The individual may make this confirmation by producing any documentation that may include the relevant information, such as a summary of benefits (for example, a summary of benefits and coverage (SBC) that includes the relevant information), or through other methods, such as by providing an attestation.126 The provider of contraceptive services would have discretion on choosing what confirmation method to accept. The Departments seek comment on additional sources of information that participants, beneficiaries, and enrollees could provide for this confirmation, including what documentation plans and issuers may already be providing to participants, beneficiaries, and enrollees independent of any Federal requirements. Excluded from the proposed definition of eligible individual are a participant or beneficiary enrolled in a group health plan established or maintained, or an enrollee in individual health insurance coverage offered or arranged, by an objecting entity that has invoked the optional accommodation. The Departments do not expect many such participants, beneficiaries, or enrollees would avail themselves of the individual contraceptive arrangement, even if they were eligible, as it would likely be easier for them to obtain contraceptive services through the accommodation. However, the Departments recognize that it may be challenging for an individual or a 126 The Departments are proposing to add sample attestation language for this purpose to the regulations at 26 CFR 54.9815–2713A(e)(2), 29 CFR 2590.715–2713A(e)(2), and 45 CFR 147.131(d)(2). PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 7253 provider of contraceptive services to distinguish between an eligible individual, as defined under these proposed rules, and a participant or beneficiary enrolled in a group health plan established or maintained, or an enrollee in individual health insurance coverage offered or arranged, by an objecting entity that has invoked the optional accommodation. Therefore, the Departments seek comment on whether these individuals should be included within the definition of eligible individual. The Departments acknowledge that grandfathered health plans are not required to comply with section 2713 of the PHS Act, including the implementing regulations. However, because there are relatively few grandfathered plans and coverage still in existence,127 and these plans and issuers providing grandfathered coverage may voluntarily, or as required by State law, provide contraceptive coverage, the Departments are not proposing to apply the proposed individual contraceptive arrangement to women enrolled in grandfathered plans. These proposed rules, if finalized, would not place any additional obligations on a plan or health insurance issuer. Under this individual contraceptive arrangement, an exempt entity would not have to provide any verbal or written documentation to an eligible individual, a provider of contraceptive services, a health insurance issuer, a third party administrator, a government agency, or any other person or entity, that an exempt entity would not already be required to provide by virtue of sponsoring, arranging, or offering health coverage in general.128 Under these 127 In 2020, the Departments estimated that there are 2.5 million ERISA-covered plans offered by private employers that cover an estimated 136.2 million participants and beneficiaries in those private employer-sponsored plans. Similarly, the Departments estimated that there were 84,087 State and local governments that offer health coverage to their employees, with an estimated 32.8 million participants and beneficiaries in those employersponsored plans. The Departments estimated that, of firms offering health benefits, 400,000 sponsor ERISA-covered plans that are grandfathered (or include a grandfathered benefit package option) and cover 19.1 million participants and beneficiaries. The Departments further estimated there are 13,454 State and local governments offering at least one grandfathered health plan and 4.6 million participants and beneficiaries covered by a grandfathered State or local government plan. See 85 FR 81097, 81108. The Departments expect that those numbers are now somewhat lower. 128 However, these proposed rules would not prohibit an eligible individual from requesting that the plan or coverage provide documentation showing the plan or coverage does not cover all or a subset of contraceptive services as generally required under 26 CFR 54.9815–2713(a)(1)(iv), 29 E:\FR\FM\02FEP2.SGM Continued 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7254 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules receive women’s health care. As the Departments have explained, however, they have been unable to identify a mechanism that would achieve seamless coverage while addressing the religious objections to the contraceptive coverage requirement and the existing accommodations as well as resolving the long-running litigation.129 Nonetheless, the proposed individual contraceptive arrangement would be more effective than the existing regulations at advancing the goals of the Women’s Health Amendment, because the current regulations provide no pathway to obtain contraceptive services at no cost for women whose employers, institutions of higher education, or health insurance issuers exercise a religious exemption and either opt not to or are not eligible to invoke the accommodation. The Departments propose to codify the proposed individual contraceptive arrangement in the same section of the regulations as the existing optional accommodation for exempt entities, as both would operate to ensure that women enrolled in coverage sponsored or offered or arranged by an exempt entity have access to contraceptive services otherwise required to be covered, without cost sharing. Therefore, the Departments propose to change the titles of 26 CFR 54.9815– 2713A, 29 CFR 2590.715–2713A, and 45 CFR 147.131 from ‘‘Accommodations in connection with coverage of certain preventive health services,’’ to ‘‘Alternate availability of certain preventive health services.’’ The Departments seek comment on all aspects of these proposed amendments. proposed rules, an eligible individual may voluntarily, without the objecting entity’s knowledge, and independent of any actions by the objecting entity, elect this individual contraceptive arrangement. The individual contraceptive arrangement option would therefore operate independently of any health plan or health insurance arrangement that involves or implicates an objecting entity. The Departments seek comment on adequate ways to ensure individuals are aware of the individual contraceptive arrangement, can learn if they are eligible, and can find participating providers to access contraceptive services at no cost. These proposed rules would also add a definition of provider of contraceptive services for purposes of 26 CFR 54.9815–2713A, 29 CFR 2590.715– 2713A, and 45 CFR 147.131 in new paragraphs 26 CFR 54.9815– 2713A(g)(2), 29 CFR 2590.715– 2713A(g)(2), and 45 CFR 147.131(g)(2). The term ‘‘provider of contraceptive services’’ would mean any health care provider (including a clinician, pharmacy, or other facility) acting within the scope of that provider’s license, certification, or authority under applicable law to provide contraceptive services. This definition is intended to be interpreted broadly to encompass any provider or facility authorized to provide any contraceptive services, including when provided via telehealth or mail. The Departments specifically seek comment on whether there are any entities that would be equipped to facilitate the individual contraceptive arrangement that would not be included within this definition. The Departments acknowledge that this proposal would not achieve the Women’s Health Amendment’s goal of ensuring that women have seamless cost-free coverage of contraceptives, because the individual contraceptive arrangement would require some additional action by the affected women and could require them to obtain contraceptive care from providers other than those from whom they typically To facilitate the proposed individual contraceptive arrangement, HHS proposes to amend 45 CFR 156.50(d) to allow a participating issuer 130 on the FFE or an SBE–FP to receive an FFE or SBE–FP user fee adjustment for reimbursing a provider of contraceptive services for the costs of providing contraceptive services pursuant to the individual contraceptive arrangement.131 Additionally, for purposes of 45 CFR 156.50(a), HHS proposes that ‘‘provider of contraceptive services’’ would have the same meaning as ‘‘provider of contraceptive services’’ under proposed 45 CFR 147.131(g)(2). Under this definition, a provider of contraceptive services would not be required to be located in an FFE or SBE– FP State, but a participating issuer would need to be subject to FFE or SBE– FP user fees to be eligible to receive a user fee adjustment. In other words, a provider of contraceptive services would be able to seek reimbursement from a participating issuer in another State. To summarize, a provider of contraceptive services that incurs costs for furnishing contraceptive services pursuant to the individual contraceptive arrangement would be able to seek reimbursement of these costs from a participating issuer, with the issuer in turn receiving a reduction equal to this amount, plus an administrative allowance for costs and margin, of the issuer’s FFE or SBE–FFP user fees as discussed in detail in this section of the preamble: • In order to receive reimbursement for contraceptive services provided pursuant to the individual contraceptive arrangement, a provider of contraceptive services would be required to enter into a signed agreement with a participating issuer to reimburse the provider for the cost of furnishing contraceptive services. • For the participating issuer to receive the user fee adjustment and for the provider of contraceptive services to receive reimbursement from the participating issuer as a result of the participating issuer’s user fee adjustment, the participating issuer would be required to submit to HHS: (1) a copy of the signed agreement it entered into with the provider of CFR 2590.715–2713(a)(1)(iv), or 45 CFR 147.130(a)(1)(iv). The Departments note that a plan or coverage would be required to comply with generally applicable disclosure requirements. For example, if an individual requests that the plan or coverage provide them with a copy of their SBC, the plan or coverage would be required to furnish the SBC in accordance with existing regulations. See 26 CFR 54.9815–2715(a)(1), 29 CFR 2590.715– 2715(a)(1), and 45 CFR 147.200(a)(1). Additionally, group health plans covered by ERISA are required to provide a summary plan description to participants and beneficiaries that describe, in terms understandable to the average plan participant, the rights, benefits, and responsibilities of participants and beneficiaries. See ERISA section 102 and 29 CFR 2520.104b–2. 129 See FAQs Part 36, 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/FactSheets-and-FAQs/Downloads/ACA-FAQs-Part36_19-17-Final.pdf. 130 Under 45 CFR 156.50(a), a participating issuer means any issuer offering a plan that participates in the specific function that is funded by user fees. This term may include: health insurance issuers, QHP issuers, issuers of multi-State plans (as defined in 45 CFR 155.1000(a)), issuers of stand-alone dental plans (as described in 45 CFR 155.1065), or other issuers identified by an Exchange. The references to ‘‘participating issuer’’ in this section would mean a participating issuer on the FFE or an SBE–FP. 131 HHS notes it is not proposing to change the substantive requirements on participating issuers and third party administrators when participating issuers make payments to third party administrators, nor is HHS proposing to make substantive changes related to information and documentation requirements on third party administrators and participating issuers that have made arrangements with each other. To conform with proposed changes for the individual contraceptive arrangement, HHS would amend 45 CFR 156.50 to include references to the individual contraceptive arrangement and re-designate paragraphs to include references to the individual contraceptive arrangement provisions. These changes are discussed in more detail in the following paragraphs. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 III. Overview of Proposed Rules— Department of Health and Human Services Financial Support (45 CFR 156.50) PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 contraceptive services; (2) information that identifies the provider of contraceptive services it reimbursed or will reimburse; and (3) the total dollar amount of the payments it made or will make to reimburse the provider of contraceptive services for the costs of furnishing contraceptive services to eligible individuals pursuant to the individual contraceptive arrangement. • If the necessary conditions are met, the participating issuer would receive an adjustment to its user fee obligation equal to the total amount of costs of furnishing contraceptive services for each provider of contraceptive services in accordance with the individual contraceptive arrangement, plus an allowance for administrative costs and margin.132 If the adjustment exceeds the user fees owed in the month of the initial adjustment or in any later month, any excess adjustment would be carried over to later months. • Under these proposed rules and the current regulation, the administrative allowance—which would be at least 10 percent of the total dollar amount of the costs of furnishing contraceptive services pursuant to the individual contraceptive arrangement 133—would be specified by HHS in the annual HHS notice of benefit and payment parameters or other rulemaking. If the administrative allowance for an applicable year is not specified in that year’s HHS notice of benefit and payment parameters or other rulemaking, then the administrative allowance would be the amount last specified in rulemaking. • The participating issuer may pay the provider of contraceptive services as soon as the contraceptive services are delivered pursuant to the individual contraceptive arrangement, but the participating issuer would be required to pay the provider, no later than within 60 days of receipt of any adjustment of a user fee. No payment would be 132 The allowance for administrative costs and margin is intended to cover a participating issuer’s administrative costs associated with reimbursing providers of contraceptive services, such as the costs associated with entering into arrangements with such providers and submitting documentation to seek a reduction in the user fee obligation, as well as provide a margin to ensure that participating issuers receive appropriate compensation for providing such reimbursements. See 78 FR 39870, 39884. 133 Pursuant to 45 CFR 156.50(d)(3)(ii), the minimum administrative allowance permitted for the existing third party administrator optional accommodation is also at least 10 percent of the total dollar amount of payments for contraceptive services. See 78 FR 39870, 39885. Per the HHS Notice of Benefit and Payment Parameters for 2015 (‘‘2015 Payment Notice’’), HHS set the administrative allowance for the existing third party administrator optional accommodation at 15 percent. See 79 FR 13743, 13809 (March 11, 2014). VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 required with respect to the allowance for administrative costs and margin. This proposal sets the latest date on which the participating issuer must reimburse the provider of contraceptive services. This proposal would not preclude the participating issuer and provider of contraceptive services from agreeing that the participating issuer would reimburse the provider at more frequent intervals, such as on a monthly or quarterly basis, or upfront for the full cost of services provided during the applicable benefit year rather than in the following benefit year in which the issuer receives the monthly user fee adjustment. Each of the items from the preceding list laying out this proposed user fee adjustment is discussed in more detail in the following paragraphs. HHS proposes to add paragraph (d)(1)(iii) to 45 CFR 156.50 to require that a provider of contraceptive services and a participating issuer enter into an agreement for that issuer to seek a user fee adjustment as a result of reimbursing the provider’s costs pursuant to the individual contraceptive arrangement. An agreement between the participating issuer and the provider of contraceptive services would be a condition of participation in the individual contraceptive arrangement and required to receive reimbursement for the costs of furnishing contraceptive services. HHS proposes to amend 45 CFR 156.50(d)(2)(i) to establish the information and documentation a participating issuer that is eligible for a user fee adjustment must provide to HHS to receive a user fee adjustment as a result of reimbursement of (or intention to reimburse pursuant to proposed 45 CFR 156.50(d)(5)) the cost of furnishing contraceptive services incurred by a provider of contraceptive services. HHS proposes to amend 45 CFR 156.50(d)(2)(i)(A) to require that, to receive a user fee adjustment under the individual contraceptive arrangement, a participating issuer must submit to HHS identifying information on each provider of contraceptive services it reimbursed (or will reimburse pursuant to proposed 45 CFR 156.50(d)(5)). Additionally, HHS proposes to add 45 CFR 156.50(d)(2)(i)(D) and (E) to require the participating issuer offering a plan through the FFE or an SBE–FP to submit: (1) documentation that demonstrates that the participating issuer and the provider of contraceptive services have entered into an agreement through which the participating issuer would reimburse the provider for the costs of contraceptive services furnished under the individual contraceptive arrangement; and (2) the total dollar PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 7255 amount of the payments the participating issuer made (or will make) to reimburse the provider for the costs of furnishing those contraceptive services already provided under the individual contraceptive arrangement. To facilitate the individual contraceptive arrangement, HHS proposes that providers of contraceptive services and participating issuers, as a condition for participating in this individual contraceptive arrangement, must enter into a signed agreement and that the participating issuer must submit a copy of this agreement to HHS to satisfy the proposed submission requirements at 45 CFR 156.50(d)(2)(i)(A) and (D). HHS proposes that this signed agreement must include identifying information of the provider of contraceptive services, such as the name and contact information for the provider’s practice or facility or, if applicable, the provider’s National Provider Identifier.134 In addition, the agreement would need to include the signatures of individuals with the authority to legally and financially bind the provider of contraceptive services and the participating issuer. The agreement would need to demonstrate that the provider of contraceptive services and participating issuer have entered into an arrangement through which the participating issuer will reimburse the provider for the costs of furnishing contraceptive services in accordance with the individual contraceptive arrangement at proposed 26 CFR 54.9815–2713A(e), 29 CFR 2590.715– 2713A(e), and 45 CFR 147.131(d), and that the participating issuer will seek a user fee adjustment for the amount of those eligible costs (plus an administrative allowance as specified at proposed 45 CFR 156.50(d)(3)(iii)). HHS notes that other terms of the agreement between a provider of contraceptive services and a participating issuer, such as the period of time over which the agreement is effective, are at the discretion of the participating issuer and provider. HHS also notes that, to facilitate the individual contraceptive arrangement, a single participating issuer may enter into separate agreements with more than one provider of contraceptive services. Additionally, providers of contraceptive services may enter into separate agreements with more than one participating issuer. HHS recognizes that there may be additional 134 See ‘‘NPI: What You Need to Know’’ (March 2021), available at https://www.cms.gov/Outreachand-Education/Medicare-Learning-Network-MLN/ MLNProducts/Downloads/NPI-What-You-Need-ToKnow.pdf. E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7256 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules forms of documentation that could satisfy these proposed submission requirements; thus, HHS seeks comment on the types of documentation HHS should accept. HHS also seeks comment on the types of information participating issuers must submit to adequately identify the providers of contraceptive services with which the participating issuers have entered into such arrangements. HHS proposes to add 45 CFR 156.50(d)(2)(i)(E) to require a participating issuer to submit the total dollar amount of the provider’s costs of furnishing contraceptive services under the individual contraceptive arrangement and for which a participating issuer would be able to receive a user fee adjustment (plus an administrative allowance as specified at proposed 45 CFR 156.50(d)(3)(iii)). HHS recognizes that the costs of furnishing contraceptive services under the individual contraceptive arrangement would vary based on the specific contraceptive service provided and the time it takes to provide that service. Because of this cost variance, HHS proposes to allow a provider of contraceptive services to calculate its actual costs of furnishing these contraceptive services and to provide that calculation of actual costs to the participating issuer offering a plan through the FFE or an SBE–FP with which the provider has entered into an arrangement for reimbursement of these costs. Consistent with how the Departments have interpreted section 2713 of the PHS Act as applied to group health plans, and health insurance issuers offering group or individual health insurance coverage,135 HHS proposes that the actual costs of the provider of contraceptive services would include items and services that are integral to the furnishing of the contraceptive service, for an amount agreed to by the provider and eligible issuer, regardless of whether the provider would typically bill for the item or service separately. This would include the administrative costs incurred by participating providers of contraceptive services to deliver the contraceptive services. HHS seeks comment on the costs a provider of contraceptive services could include in its calculation of actual costs provided to the participating issuer with which it has entered into an arrangement for reimbursement of these costs. In 135 85 FR 71142, 71174. See also FAQs Part 54, Q1, available at https://www.dol.gov/sites/dolgov/ files/EBSA/about-ebsa/our-activities/resourcecenter/faqs/aca-part-54.pdf and https:// www.cms.gov/files/document/faqs-part-54.pdf. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 determining how a provider’s costs should be calculated for reimbursement under the individual contraceptive arrangement, HHS considered whether costs should be calculated using a standard methodology. However, due to the wide variation in costs depending on the specific contraceptive services provided and how the service is delivered, HHS determined that permitting a provider of contraceptive services to calculate its actual costs would allow the provider to receive a more accurate cost reimbursement. HHS seeks comment on whether the reimbursement should be equal to the provider’s actual costs of furnishing contraceptive services to eligible individuals or whether HHS should instead establish a standard methodology to calculate costs. HHS seeks comment on benchmarks HHS could use to establish a reimbursement rate. Additionally, HHS proposes to revise 45 CFR 156.50(d)(3)(ii) to permit a participating issuer that satisfies the requirements as proposed in 45 CFR 156.50(d)(2) to receive a user fee adjustment equal to the total dollar amount of a provider’s costs of furnishing contraceptive services plus the administrative allowance. HHS proposes to re-designate the administrative allowance provision at existing 45 CFR 156.50(d)(3)(ii) to new paragraph (d)(3)(iii), and amend it to establish that the allowance should be calculated as a percentage of the sum of the total dollar amount of the payments for contraceptive services provided to a third party administrator as calculated at 45 CFR 156.50(d)(3)(i) and the provider’s costs of furnishing contraceptive services as calculated at proposed 45 CFR 156.50(d)(3)(ii). HHS is of the view that it is appropriate to provide an administrative allowance because participating issuers will incur additional administrative costs to providers of contraceptive services for the actual cost of furnishing contraceptive services. As established in the 2015 Payment Notice,136 the current administrative allowance is 15 percent for issuers that have entered into agreements with third party administrators to reimburse the cost of contraceptive services with respect to women getting non-contraceptive coverage through eligible organizations.137 Consistent with the 2015 Payment Notice administrative allowance for third party administrators, HHS proposes an administrative allowance of at least 10 percent for 136 79 137 79 PO 00000 FR 13743. FR 13743 at 13809. Frm 00022 Fmt 4701 issuers that enter into agreements with providers of contraceptive services pursuant to the individual contraceptive arrangement. HHS proposes a 15 percent administrative allowance for this adjustment, similar to the administrative allowance set in the 2015 Payment Notice for third party administrators. Additionally, for clarification and consistency with current practice, HHS proposes to clarify at 45 CFR 156.50(d)(3)(iii) that, unless a new allowance for administrative costs and margin is specified in the applicable year’s HHS notice of benefit and payment parameters or other rulemaking, HHS will, for a particular calendar year, maintain the allowance that was last specified in rulemaking. HHS believes this proposal makes clear the allowance and the mechanism HHS would use to propose any changes to the allowance. While HHS is proposing to maintain that the administrative allowance must be at least 10 percent, as set forth in the 2015 Payment Notice, the current, applicable administrative allowance is 15 percent.138 HHS is not proposing making changes to this percentage in this rulemaking. HHS also proposes to amend 45 CFR 156.50(d)(5) to provide that a participating issuer may provide payments for contraceptive services as soon as they are delivered, but must provide payments within 60 days to a third party administrator or a provider of contraceptive services. Such payments must be made within 60 days of receipt of any adjustment of a user fee in an amount that is no less than the portion of the adjustment attributable to the total dollar amount of the payments for contraceptive services submitted by the third party administrator or provider of contraceptive services. This proposed amendment to 45 CFR 156.50(d)(5) is intended to clarify and codify in regulation the current policy as applied to the existing optional accommodation with respect to a third party administrator, as well as to extend this policy to providers of contraceptive services pursuant to the individual contraceptive arrangement. The adjustments to a participating issuer’s user fee through the FFE or an SBE–FP for a given year are based on data submitted by third party administrators to HHS regarding the prior benefit year, and adjustments to a participating issuer’s current user fee charges are made on a monthly basis based on the data received to date regarding the payments for contraceptive services from the prior year. For example, a 138 79 Sfmt 4702 E:\FR\FM\02FEP2.SGM FR 13743 at 13809. 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules participating issuer and a provider of contraceptive services could agree that, prior to and in anticipation of receiving a user fee adjustment as specified at 45 CFR 156.50(d)(3), the participating issuer would reimburse the provider on a monthly or quarterly basis in an amount equal to the provider’s costs of furnishing contraceptive services in accordance with the individual contraceptive arrangement. However, HHS notes that if any monthly user fee adjustment that a participating issuer receives does not cover the full costs of contraceptive services provided by the provider of contraceptive services or the full payment for contraceptive services made or arranged for by the third party administrator for the applicable benefit year, then the provider may not receive full reimbursement for all contraceptive services furnished during the applicable calendar year within 60 days of when the participating issuer has first received an adjustment to its FFE or SBE–FP user fee. Thus, HHS proposes that the signed agreement between a participating issuer and a provider of contraceptive services must define the terms for payment to the provider. Next, HHS proposes to amend 45 CFR 156.50(d)(6) to establish that, for 10 years following the calendar year for which the user fee adjustment is received, a participating issuer must retain documentation demonstrating that it timely paid each provider of contraceptive services for which it received any user fee adjustment. These proposals align with the existing recordkeeping requirements for a participating issuer under the third party administrator contraceptive user fee adjustment process. In addition, HHS proposes to add 45 CFR 156.50(d)(8) to establish recordkeeping requirements with which providers must comply as a condition of participating in the individual contraceptive arrangement. HHS proposes to require that, for 10 years following the contraceptive service being provided, providers of contraceptive services must maintain documentation showing the actual costs of furnishing contraceptive services in compliance with the requirements of the individual contraceptive arrangement and documentation supporting the total dollar amount of those costs, and must make this documentation available upon request to HHS, the HHS Office of the Inspector General, the Comptroller General, and their designees. This timeframe is similar to the standard used for third party administrators under the existing optional accommodation and the standards used for other Exchange programs. We solicit VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 comment on this timeframe and whether the timeframe should be tied to the issuer payment instead of the timeframe from when the contraceptive service is being provided. As explained previously, an eligible individual would be able to access the individual contraceptive arrangement without the exempt entity providing any documentation to an issuer, third party administrator, or HHS. Nevertheless, a provider of contraceptive services seeking to furnish contraceptive services pursuant to the individual contraceptive arrangement would be required to confirm an individual’s eligibility for the individual contraceptive arrangement. As explained earlier in this preamble, the individual may make this confirmation by producing a summary of benefits, such as an SBC that includes the relevant information or through other methods, such as by providing an attestation. The provider of contraceptive services would have discretion on choosing what confirmation method to accept. HHS expects that providers would choose to document receiving this representation in a variety of ways, such as by making a notation in a specific eligible individual’s medical chart. HHS is of the view that allowing providers of contraceptive services to choose how they document an eligible individual’s representation would decrease operational barriers related to these recordkeeping requirements and would thereby allow a greater number of interested providers to furnish contraceptive services under the individual contraceptive arrangement. Recognizing the various types of representations a provider of contraceptive services could receive from or on behalf of an individual to demonstrate that individual’s eligibility for the individual contraceptive arrangement, HHS proposes to add 45 CFR 156.50(d)(9) and (10). These proposals would preserve, if certain reliance requirements are met, a provider’s ability to receive reimbursement for contraceptive services furnished, as well as a participating issuer’s ability to receive a user fee adjustment, if the representation as to the individual’s eligibility for the individual contraceptive arrangement is later determined to be incorrect. Specifically, proposed 45 CFR 156.50(d)(9) would establish that if a provider of contraceptive services relies reasonably and in good faith on a representation that the individual is eligible to receive contraceptive services pursuant to the individual contraceptive arrangement, and the representation is later PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 7257 determined to be incorrect, then the provider of contraceptive services would be considered to have received a representation by an eligible individual for purposes of receiving a reimbursement for contraceptive services furnished by a participating issuer, and would meet any requirements related to maintaining documentation of this representation. Similarly, 45 CFR 156.50(d)(10), if finalized, would establish that if a participating issuer relies reasonably and in good faith on the provider’s representation that the provider of contraceptive services furnished contraceptive services for an eligible individual, and the representation the provider received from or on behalf of the individual is later determined to be incorrect, then the participating issuer would meet any requirements that involve the provider’s receipt of such representation. HHS also proposes to add 45 CFR 156.50(d)(11) to preserve, if certain requirements are met, the ability of a participating issuer to receive a user fee adjustment if the provider’s representation to the participating issuer that the provider furnished contraceptive services in accordance with the individual contraceptive arrangement is later determined to be incorrect. First, proposed 45 CFR 156.50(d)(11) would establish that if a participating issuer relies reasonably and in good faith on a provider’s representation that the provider furnished contraceptive services in accordance with the individual contraceptive arrangement, and the representation by the provider of contraceptive services is later determined to be incorrect, then the participating issuer’s good faith reliance on that incorrect representation would meet any requirements that involve that representation. Second, the proposal at 45 CFR 156.50(d)(11) would apply only when a participating issuer has already reimbursed a provider of contraceptive services for any amount of its costs of furnishing contraceptive services as specified in proposed 45 CFR 156.50(d)(2)(i)(E). HHS is of the view that it is appropriate to limit this proposal to instances in which the participating issuer has already paid the provider of contraceptive services. If the participating issuer has not yet paid the provider of contraceptive services at the time the provider’s representation is determined to be incorrect, the participating issuer will not have incurred a financial loss by no longer having the ability to receive a user fee adjustment. E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7258 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules To participate in the individual contraceptive arrangement, proposed 45 CFR 147.131(d)(1) would require that a provider of contraceptive services furnish contraceptive services to the eligible individual without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof. Consistent with this requirement, HHS proposes to include in new 45 CFR 156.50(d)(1)(iii), (d)(10), and (d)(11) that a provider of contraceptive services must furnish contraceptive services to the eligible individual ‘‘without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof.’’ Finally, HHS proposes technical corrections to 45 CFR 156.50(d)(1)(ii), (d)(2)(i)(A) and (B), (d)(2)(ii), (d)(2)(iii)(B), and (d)(7)(i) to align with these proposed changes. First, HHS proposes a technical correction to 45 CFR 156.50(d)(1)(ii), (d)(2)(i)(A) and (B), (d)(2)(ii), (d)(2)(iii)(B), and (d)(7)(i) to update cross-references to 26 CFR 54.9815–2713A(a)(4) and 29 CFR 2590.715–2713A(a)(4), which have been re-designated to 26 CFR 54.9815– 2713A(a)(1)(iii) and 29 CFR 2590.715– 2713A(a)(1)(iii), respectively. Second, HHS proposes a technical correction to 45 CFR 156.50(d)(1)(ii) to clarify that a participating issuer participating on an SBE–FP is eligible to receive an adjustment to its Federal user fee amounts that reflect the value of contraceptive services it has agreed to reimburse to third party administrators or has agreed to reimburse to providers for the providers’ actual costs of furnishing contraceptive services consistent with this individual contraceptive arrangement. In the HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards final rule,139 HHS explained that issuers participating through an SBE–FP have been able to qualify for user fee adjustments as provided for in the HHS Notice of Benefit and Payment Parameters for 2017,140 and amended 45 CFR 156.50 to make explicit that issuers are eligible to receive SBE–FP user fee adjustments.141 Thus, HHS proposes to make a conforming amendment to 45 CFR 156.50(d)(1)(ii). HHS notes that it is not proposing to raise the FFE or SBE–FP user fee rates finalized in the HHS Notice of Benefit 139 86 FR 24140 at 24229 (May 5, 2021). FR 12203 at 12293 (March 8, 2016). 141 86 FR 24229. 140 81 VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 and Payment Parameters for 2023 142 to offset the FFE and SBE–FP user fee adjustments, and HHS estimates reimbursements for contraceptive services will represent only a small portion of total FFE user fees. HHS is of the view that the proposed amendment to 45 CFR 156.50(d)(2)(i)(A) and the proposed addition of 45 CFR 156.50(d)(2)(i)(D), which would require participating issuers, but not providers of contraceptive services, to submit documentation demonstrating the agreement, would mitigate the operational burden on providers of providing contraceptive services through the individual contraceptive arrangement, without materially increasing the burden for participating issuers that are already familiar with the process of submitting information to HHS as part of the existing conditions for receiving a user fee adjustment through an arrangement with a third party administrator, pursuant to the requirements of 45 CFR 156.50(d). To facilitate the individual contraceptive arrangement, HHS proposes to make available to providers of contraceptive services a list of participating issuers that have previously participated in the third party administrator optional contraceptive user fee adjustment process under current 45 CFR 156.50(d). HHS seeks comment on this proposal, including whether prior participating issuers or issuers that intend to participate in these arrangements in future years would have concerns with HHS making this public disclosure. HHS seeks comment on the proposed amendments to 45 CFR 156.50(d). As mentioned in section I.B of this preamble, section 3 of E.O. 14009 directs HHS and other heads of agencies to review all agency actions, such as the FFE or SBE–FP user fees, to determine whether they are inconsistent with policy priorities described in section 1 of E.O. 14009, to include protecting and strengthening the ACA and making high-quality health care accessible and affordable for all individuals.143 142 See 87 FR 27208 at 27288. In part 3 of the HHS Notice of Benefit and Payment Parameters 2022 final rule, HHS finalized the repeal of the Exchange Direct Enrollment (DE) option and the removal of 45 CFR 155.221(j). See 86 FR 53412 at 53429 (September 27, 2021). To align with these actions, HHS finalized in the 2023 Payment Notice conforming amendments to 45 CFR 156.50(c) and (d) to remove references to 45 CFR 155.221(j) and the Exchange DE option. 143 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 PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 Collectively, these proposed rules on the user fee adjustment would further the goals of E.O. 14009 by making highquality health care that is inclusive of contraceptive services accessible and affordable for more individuals. Under the current rules, participants, beneficiaries, and enrollees enrolled in a group health plan or coverage sponsored, arranged, or provided by an objecting entity subject to a moral exemption lack contraceptive coverage and access to contraceptive services without cost sharing. The Departments lack the data to accurately estimate the number of, or demographics of, participants, beneficiaries, or enrollees who have been affected by previous rules, as objecting employers, institutions of higher education, and issuers are not required to notify HHS of their objection. However, as discussed earlier in this preamble, lowincome women face a disproportionate burden of out-of-pocket spending on contraceptive services.144 Also, as noted in section I.B, section 3 of E.O. 14076 requires the Secretary of HHS to submit a report to the President that is focused on, among other priorities, ‘‘protect[ing] and expand[ing] access to the full range of reproductive healthcare services, including actions to enhance family planning services such as access to emergency contraception,’’ and ‘‘promoting awareness of and access to the full range of contraceptive services.’’ Collectively, these proposed rules are consistent with the objectives of E.O. 14076 by protecting and expanding access to the full range of reproductive health care services and enhancing family planning services, and promoting access to the full range of contraceptive services. IV. Severability It is the Departments’ intent that if any provision of these proposed rules, if finalized, is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, the rules shall be construed so as to continue to give maximum effect to the rules as permitted by law, unless the holding shall be one of utter invalidity or unenforceability. In the event a provision is found to be utterly invalid or unenforceable, the provision shall be severable from these proposed rules as finalized, as well as the final rules they amend, and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. opposed to providing certain contraceptive coverage. 144 See FN 54. E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules V. Response to Comments Because of the large number of public comments that the Departments normally receive on Federal Register documents, the Departments are not able to acknowledge or respond to them individually. The Departments will consider all comments received by the date and time specified in the DATES section of this preamble, and, when the Departments proceed with a subsequent document, the Departments will respond to the comments in the preamble to that document. khammond on DSKJM1Z7X2PROD with PROPOSALS2 VI. Economic Impact and Paperwork Burden A. Summary These proposed rules would expand access to contraceptive services without cost sharing for women through the provision of a new individual contraceptive arrangement, whereby an eligible individual would be able to obtain contraceptive services from willing providers of contraceptive services at no cost to the individual, and the providers of contraceptive services would be reimbursed for the costs of furnishing contraceptive services by a participating issuer on the FFE or an SBE–FP through an adjustment to the FFE or SBE–FP user fee for the participating issuer. These proposed rules would maintain the existing exemptions and optional accommodations for eligible entities and individuals claiming a religious objection to providing contraceptive coverage. These proposed rules would also expand access to contraceptive services without cost sharing by eliminating the exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs. The Departments have examined the effects of these proposed rules as required by Executive Order 13563 (76 FR 3821, January 21, 2011, Improving Regulation and Regulatory Review); Executive Order 12866 (58 FR 51735, October 4, 1993, Regulatory Planning and Review); the Regulatory Flexibility Act (September 19, 1980, Pub. L. 96– 354); section 1102(b) of the Social Security Act (42 U.S.C. 1102(b)); section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995, Pub. L. 104–4); Executive Order 13132 (64 FR 43255, August 10, 1999, Federalism); and the Congressional Review Act (5 U.S.C. 804(2)). B. Executive Orders 12866 and 13563 Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. Section 3(f) of Executive Order 12866 defines a ‘‘significant regulatory action’’ as an action that is likely to result in a rule: (1) having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities (also referred to as ‘‘economically significant’’); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects (for example, $100 million or more in any one year), and a ‘‘significant’’ regulatory action is subject to review by the Office of Management and Budget (OMB). The Departments anticipate that this regulatory action is not likely to have economic impacts of $100 million or more in at least 1 year and is therefore not expected to be economically significant under Executive Order 12866. OMB has determined, however, that the actions are significant within the meaning of section 3(f)(4) of the Executive Order. Therefore, the Departments have provided an assessment of the potential costs, benefits, and transfers associated with these proposed rules. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by OMB. 1. Need for Regulatory Action Previous rules, regulations, and court decisions have left many women without contraceptive coverage and access to contraceptive services without cost sharing. These proposed rules, if finalized, seek to resolve the longrunning litigation with respect to religious objections to providing contraceptive coverage, by honoring the objecting entities’ religious objections, PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 7259 while also ensuring that women enrolled in a group health plan established or maintained, or in health insurance coverage offered or arranged, by an objecting entity described in 45 CFR 147.132(a) have the opportunity to obtain contraceptive services at no cost. These proposed rules would also eliminate the exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs, which prevents access to contraceptive services without cost sharing. 2. Summary of Impacts These proposed rules would expand access to contraceptive services without cost sharing and reduce out-of-pocket spending on contraceptive services for individuals eligible for the individual contraceptive arrangement. Issuers that reimburse providers of contraceptive services for the costs of furnishing contraceptive services for individuals eligible for the individual contraceptive arrangement and in turn seek an adjustment to the FFE or SBE–FP user fee would incur administrative costs, which would be offset by Federal payments in the form of user fee adjustments. Providers of contraceptive services would also incur administrative costs associated with furnishing the contraceptive services and entering into a signed agreement with a participating issuer on the FFE or an SBE–FP to receive reimbursement for the contraceptive services furnished, and individuals might incur costs related to finding providers of contraceptive services willing to participate in the program. These proposed rules would also expand access to contraceptive services without cost sharing and reduce out-ofpocket spending on contraceptive services for individuals by eliminating the exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs. However, as noted later in the Transfers discussion of this section the Departments do not have information on the number of entities and individuals that have claimed a moral exemption to providing contraceptive coverage, and are therefore uncertain of the amount of the potential transfer from plans and issuers to participants, beneficiaries, and enrollees due to reduced out-ofpocket spending on contraceptive services associated with the proposed elimination of the exemption for entities and individuals that object to contraceptive coverage based on nonreligious moral beliefs. In accordance with Executive Order 12866, the Departments are of the view E:\FR\FM\02FEP2.SGM 02FEP2 7260 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules that the benefits of this regulatory action justify the costs. The expected benefits, costs, and transfers associated with these proposed rules are summarized in Table 1 and discussed in detail later in this section. TABLE 1—ACCOUNTING TABLE Benefits: Qualitative: • Expansion of access to contraceptive services without cost sharing for eligible individuals through the creation of a new individual contraceptive arrangement. • Expansion of access to contraceptive services without cost sharing for participants, beneficiaries, and enrollees through the elimination of the exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs. • Potential increase in health equity, given the expected reduction in out-of-pocket spending on contraceptive services by individuals. • Potential reduction in unintended pregnancies and improved health outcomes for individuals. Costs: Estimate (million) Year dollar Discount rate (percent) Period covered $30.11 30.11 2022 2022 7 3 2023–2027 2023–2027 Annualized Monetized ($/year) ........................................................................ Quantitative: • Administrative costs of approximately $4.7 million annually to participating providers of contraceptive services related to signing agreements with issuers. These costs would likely be included in the service charges of providers of contraceptive services and ultimately incurred by the Federal Government. • Administrative costs of approximately $14.5 million annually to participating providers of contraceptive services associated with verifying eligibility for the proposed individual contraceptive arrangement, submitting amounts to participating issuers on the FFE or an SBE–FP to receive reimbursement for the contraceptive services furnished, and maintaining records. These costs would likely be included in the service charges of providers of contraceptive services and ultimately incurred by the Federal Government. • Administrative costs and margin of approximately $10.4 million annually to participating issuers associated with signing agreements with participating providers of contraceptive services, processing amounts requested from participating providers of contraceptive services, submitting required information to HHS, and maintaining records. These administrative costs would be offset by Federal payments in the form of adjustments to FFE and SBE–FP user fees. • Costs of approximately $590,077 annually to eligible individuals that participate in the individual contraceptive arrangement to confirm eligibility to their provider of contraceptive services. Qualitative: • Potential costs to eligible individuals associated with finding providers of contraceptive services that are willing to participate in the individual contraceptive arrangement. • Potential reduction in health care costs due to a reduction in unintended pregnancies and improved health outcomes. • Potential cost savings to states associated with reduced spending on State-funded programs that provide contraceptive services. • Potential cost savings to states associated with a reduction in unintended pregnancies that would otherwise impose costs to states. Transfers: Estimate (million) Year dollar Discount rate (percent) Period covered $49.9 49.9 2022 2022 7 3 2023–2027 2023–2027 Annualized Monetized ($/year) ........................................................................ Quantitative: • Transfer of $49.9 million annually from the Federal Government to eligible individuals who would spend less out-of-pocket on contraceptive services, in the form of user fee adjustments to participating issuers who would reimburse providers of contraceptive services for the costs of furnishing participants, beneficiaries, and enrollees with contraceptive services as a result of the individual contraceptive arrangement. Qualitative: • Potential transfer from plans and issuers to participants, beneficiaries, and enrollees who would gain access to contraceptive services without cost sharing as a result of the elimination of the exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs and who spend less out-of-pocket on contraceptive services as a result. khammond on DSKJM1Z7X2PROD with PROPOSALS2 Number of Affected Entities The Departments lack the data to accurately estimate the number of eligible individuals who would participate in the individual contraceptive arrangement. In the October 2017 Religious Exemption interim final rules and the November 2018 Religious Exemption final rules, the Departments noted that the 122 nonprofit entities that had filed litigation challenging the accommodation process and the 87 VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 closely held for-profit entities that had filed suit challenging the contraceptive coverage requirement in general could have been affected by the November 2018 Religious Exemption final rules, but were uncertain how many of these organizations would use the expanded exemption provided under the November 2018 Religious Exemption final rules and how many of these entities would use the optional accommodation process. The Departments assumed that slightly more PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 than half of these entities, or 109 organizations, would use the expanded exemption. The Departments previously estimated that between 70,500 and 126,400 individuals would be affected by the November 2018 Religious Exemption final rules. Since the implementation of the November 2018 Religious Exemption final rules, additional entities may have claimed a religious exemption to contraceptive coverage without participating in the E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules optional accommodation process. For this reason, the Departments view the estimate of 126,400 individuals to be the lower bound estimate of the number of eligible individuals and 109 health plans to be the lower bound estimate of the number of exempt entities. The Departments seek comment on the number of entities that have claimed a religious exemption to providing contraceptive coverage without using the optional accommodation process and the number of individuals who might receive contraceptive coverage through the provision of the individual contraceptive arrangement. Eligible individuals would need to find providers of contraceptive services that would be willing to participate in the individual contraceptive arrangement. The Departments lack sufficient information to accurately estimate the number of providers of contraceptive services that would participate. The Departments assume that at least 10 pharmacy chains (including mail order pharmacies) would participate. The Departments also assume that for each exempt entity, the participants, beneficiaries, and enrollees in its health plan or coverage are located in the same geographical area, and there would be, on average, 20 providers of contraceptive services (10 clinicians or facilities, and at least 10 retail pharmacies) in the area that would participate in the individual contraceptive arrangement.145 Based on these assumptions, for the participants, beneficiaries, and enrollees in the plans for the 109 exempt entities, there would be approximately 2,180 participating providers of contraceptive services (1,090 retail pharmacies and 1,090 clinicians and facilities) that would participate in the individual contraceptive arrangement. If these providers of contraceptive services already participate in the health plan’s provider network, an eligible individual would be able to receive contraceptive services from one of their regular providers of contraceptive services or another in-network provider of contraceptive services. However, it is possible that an eligible individual would need to find a provider of contraceptive services other than the provider or providers from whom the individual typically receives care in order to access contraceptive services at no cost. The Departments seek comment on the number of providers of contraceptive services that would 145 Although pharmacies are generally licensed as facilities, for purposes of this regulatory impact analysis, the Departments treat them separately. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 participate in the individual contraceptive arrangement. These proposed rules would also eliminate the exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs. 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 nonreligious moral objections, the Departments assumed that the exemption would be used by nine nonprofit entities and nine for-profit entities and that approximately 15 women may incur contraceptive costs due to for-profit entities using the moral exemption. The Departments do not have any data on how many individuals object to contraceptive coverage based on non-religious moral beliefs. Benefits These proposed rules would increase access to contraceptive services without cost sharing through the individual contraceptive arrangement for eligible individuals and the elimination of the exemption for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs. As stated in section I.B of this preamble, 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. Prior to the implementation of the ACA, outof-pocket expenses for contraceptive services represented a significant portion, estimated to range from 30 percent to 44 percent, of a woman’s total out-of-pocket health care spending.146 It has been estimated that the implementation of the ACA contraceptive coverage requirement led to out-of-pocket savings to consumers on contraceptive pills of approximately $1.4 billion between 2012 and 2013.147 Additionally, several studies have found that the ACA contraceptive coverage requirement increased access to and utilization of contraceptives.148 The 146 Nora B. & Polsky, D. (2015). ‘‘Women Saw Large Decrease in Out-Of-Pocket Spending for Contraceptives After ACA Mandate Removed Cost Sharing.’’ Health Affairs; 34(7): 1204–1211. 147 Becker, N. & Polsky, D. (2015). ‘‘Women Saw Large Decrease In Out-Of-Pocket Spending For Contraceptives After ACA Mandate Removed Cost Sharing.’’ Health Affairs, 34(7): 1204–1211. See also Sobel, L., Salganicoff, A. et al. (2018). ‘‘New Regulations Broadening Employer Exemptions to Contraceptive Coverage: Impact on Women.’’ KFF Issue Brief. Available at https://www.kff.org/healthreform/issue-brief/new-regulations-broadeningemployer-exemptions-to-contraceptive-coverageimpact-on-women/. 148 Becker, N. (2018). ‘‘The Impact of Insurance Coverage on Utilization of Prescription PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 7261 coverage of contraceptive services has been shown to improve the consistent use of the most effective short-acting methods of contraception, and the removal of cost sharing also increases the use of more effective LARC methods.149 One study found that following the implementation of the ACA contraceptive coverage requirement, the discontinuation of use of oral contraceptive pills fell and that nonadherence to brand-name oral contraceptive pills also declined.150 Another study reported that having no copayment on contraceptive services assisted 80 percent of women in affording and using birth control, helped 60 percent choose a better method, and helped 71 percent use contraceptive services more consistently.151 These proposed rules would have similar effects, as they would increase access to contraceptive services for eligible individuals who currently do not have access to contraceptive services without cost sharing. More than half of pregnancies in 2008 (51 percent or approximately 3.4 million) were estimated to be unintended; by 2011 this number had declined to 45 percent,152 and by 2020 it had declined further to an estimated 39.5 percent,153 which may be due to a change in the frequency and type of contraceptive use over time. Studies indicate that some groups tend to have higher rates of unintended pregnancies; Contraceptives: Evidence from the Affordable Care Act.’’ Journal of Policy Analysis and Management, 37(3): 571–601; Nora, B., Keating, N. et al. (2021). ‘‘ACA Mandate Led to Substantial Increase in Contraceptive Use Among Women Enrolled in High-Deductible Health Plans.’’ Health Affairs, 40(4): 579–586; Snyder, A., Weisman, C., et al. (2018). ‘‘The Impact of the Affordable Care Act on Contraceptive Use and Costs among Privately Insured Women.’’ Women’s Health Issues, 28(3): 219–223; Weisman, C., Chuang, C., et al. (2019). ‘‘ACA’s Contraceptive Coverage Requirement: Measuring Use and Out-of-Pocket Spending.’’ Health Affairs, 38(9): 1537–1541. 149 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. 150 Pace, L., Dusetzina, S., et al. (2016). ‘‘Early Impact of the Affordable Care Act on Oral Contraceptive Cost Sharing, Discontinuation, and Nonadherence.’’ Health Affairs, 35(9): 1616–1624. 151 Bearak, J.& Johns, R. (2017). ‘‘Did Contraceptive Use Patterns Change after the Affordable Care Act? A Descriptive Analysis.’’ Women’s Health Issues, 27(3): 316–321. 152 Finer, L. & Zolna, M. (2016) ‘‘Declines in Unintended Pregnancy in the United States, 2008– 2011.’’ N Engl J Med, 374(9):843–52. 153 Permanency Risk Assessment Monitoring System: Prevalence of Selected Maternal and Child Health Indicators for all Pregnancy Risk Assessment Monitoring System (PRAMS) Sites, 2016–2020. Available at: https://www.cdc.gov/prams/pramsdata/mch-indicators/states/pdf/2020/All-SitesPRAMS-MCH-Indicators-508.pdf. E:\FR\FM\02FEP2.SGM 02FEP2 7262 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules for example, one study found that 75 percent of pregnancies among teens aged 15 to 19 years of age were unplanned,154 and another study reported that nearly 70 percent of pregnancies among unmarried women aged 20 to 29 years of age were unplanned.155 In 2008, unplanned pregnancies of those covered by Medicaid or the Children’s Health Insurance Program (CHIP) were estimated to have cost Federal and State taxpayers between $9.6 billion and $12.6 billion, and without publicly funded family planning the costs would have been an estimated $25 billion.156 In addition to the costs associated with unintended pregnancies, unintended pregnancies can pose increased health risks to both mother and baby. Women with unplanned pregnancies are less likely to receive prenatal care and have higher rates of postpartum depression and mental health problems later in life.157 Unplanned pregnancies have also been associated with increases in low birthweight and preterm births, and children born due to an unplanned pregnancy are more likely to fare worse in school achievement, have social and emotional disorders, and have less success in the labor market later in life.158 One study found evidence of a decrease in births following the elimination of cost sharing for contraceptives under the ACA; further, it showed a 22.2 percent reduction in birth rates for women in the lowest income group between 2014 and 2018 (from 8 to 6.2 per 100 women).159 These proposed rules would reduce 154 See FN 173. E., & Thomas, A. (2011). ‘‘Unintended Pregnancy and Taxpayer Spending.’’ Perspectives on Sexual & Reproductive Health, 43(2), 88–93; and Sonfield, A. and Kost, K. (2013). ‘‘Public Costs from Unintended Pregnancies and the Role of Public Insurance Programs in Paying for Pregnancy and Infant Care: Estimates for 2008.’’ Guttmacher Institute. Available at: https://www.guttmacher.org/ pubs/public-costs-of-UP.pdf. Kaye, K., Gootman, J.A., Ng, A.S., & Finley, C. (2014). ‘‘The Benefits of Birth Control in America: Getting the Facts Straight.’’ The National Campaign to Prevent Teen and Unplanned Pregnancy. Available at: https://powertodecide.org/sites/ default/files/resources/primary-download/benefitsof-birth-control-in-america.pdf. 156 Sonfield, A. & Kost, K. (2013). ‘‘Public Costs from Unintended Pregnancies and the Role of Public Insurance Programs in Paying for Pregnancy and Infant Care: Estimates for 2008.’’ Guttmacher Institute. Available at: https://www.guttmacher.org/ pubs/public-costs-of-UP.pdf. 157 ‘‘Preventing Unplanned Pregnancy.’’ National Conference of State Legislatures (2021). Available at: https://www.ncsl.org/research/health/ preventing-unplanned-pregnancy.aspx. 158 Id. 159 Dalton, V., Moniz, M., et al. (2020). ‘‘Trends in Birth Rates After Elimination of Cost Sharing for Contraception by the Patient Protection and Affordable Care Act.’’ JAMA Network Open, 3(11): e2024398. khammond on DSKJM1Z7X2PROD with PROPOSALS2 155 Monea, VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 unintended pregnancies and lead to better health outcomes for eligible individuals by increasing access to contraceptive services. Finally, these proposed rules would increase health equity, given the disproportionate burden of out-ofpocket spending on contraceptive services currently faced by low-income individuals (as those individuals with lower incomes must spend a greater percentage of their incomes on contraceptive services). As discussed earlier in this section, prior to the implementation of the ACA, out-ofpocket expenses for contraceptives represented a significant portion, estimated to range from 30 percent to 44 percent, of a woman’s total out-ofpocket health care spending.160 A recent study found that people of color (and low-income people) are more likely to live in areas in which the proportion of reproductive-aged residents have a lack of, or difficulty obtaining, reproductive and contraceptive health care—referred to as ‘‘contraception deserts.’’ 161 The study found that the proportion of the population living within these types of areas ranges from approximately 17 percent in California to approximately 50 percent in Texas. One study has shown that in 2011, women with incomes below 100 percent of the Federal poverty level had unplanned pregnancies at a rate seven times higher than those at or above 200 percent of the Federal poverty level. Unplanned pregnancies were also more common in women who have low incomes or are racial or ethnic minorities.162 The enactment of the ACA has been shown to provide gains in coverage and access to women’s reproductive health services and accompanying reduced costs for women who would otherwise be without health coverage or face large out-of-pocket costs. As noted in a recent study, even in some cases where ‘‘medical insurance is available among women in the same socioeconomic strata, unexplained disparities persist and suggest that racism and other social and clinician-level issues are factors’’ that can still result in unequal access to 160 Becker, N., & Polsky, D. (2015). ‘‘Women Saw Large Decrease in Out-Of-Pocket Spending for Contraceptives After ACA Mandate Removed Cost Sharing.’’ Health Affairs; 34(7): 1204–1211. 161 Kreitzer, R.J., Watts Smith, C., et al. (2021). ‘‘Affordable but Inaccessible? Contraception Deserts in the US States.’’ Journal of Health Politics, Policy and Law 46(2): 277–304. 162 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. PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 health care and distrust of physicians.163 Although it is believed that these proposed rules would have marginal effects on the overall level of health inequity, the presence of barriers to contraceptive coverage would be more burdensome on insured women with lower incomes and reducing those barriers could have the potential to reduce socioeconomic, racial, and ethnic disparities in health outcomes.164 Costs Participating providers of contraceptive services and issuers would need to enter into signed agreements for reimbursement of costs associated with the provision of contraceptive services to eligible individuals and would therefore incur related administrative costs. In order to estimate these costs, providers of contraceptive services have been divided into two broad categories— clinicians or facilities, and pharmacies. For each signed agreement between clinicians or facilities and issuers, the Departments estimate that, on average, senior managers would spend 4 hours (at $110.82 per hour 165), lawyers would spend 40 hours (at $142.34 per hour), legal secretaries would spend 40 hours (at $50.52 per hour), a clinician would spend 1 hour (at $284.82 per hour), and a chief executive officer would spend 15 minutes (at $204.82 per hour). The total burden for each signed agreement would be 85.25 hours, with an associated cost of approximately $8,494. There would be an estimated 1,090 signed agreements between 1,090 participating clinicians or facilities and issuers. The total estimated cost for all signed agreements between clinicians or facilities and issuers would be approximately $9.3 million. The number of signed agreements and related costs could be lower if multiple facilities are owned by the same entity. For each signed agreement between pharmacy chains and issuers, the Departments estimate that senior managers would spend 4 hours (at $110.82 per hour), lawyers would spend 40 hours (at $142.34 per hour), legal 163 Sutton, M.Y., Anachebe, F., et al. (2021) Racial and Ethnic Disparities in Reproductive Health Services and Outcomes, 2020. Obstetrics & Gynecology: 137(2): 225–233. 164 Behn, M., Pace, L.E., et al. (2019). The Trump Administration’s Final Regulations Limit Insurance Coverage of Contraception. Women’s Health Issues, 29(2): 103–106. 165 The Departments generally used data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for fringe benefits and other indirect costs). May 2021 Bureau of Labor Statistics, Occupational Employment Statistics, National Occupational Employment and Wage Estimates, available from https:// www.bls.gov/oes/current/oes_nat.htm. E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules secretaries would spend 40 hours (at $50.52 per hour), and chief executive officers would spend 30 minutes (at $204.82 per hour). The total burden for each signed agreement would be 84.5 hours, with an associated cost of approximately $8,260. There would be an estimated 10 signed agreements between 10 participating pharmacy chains and issuers. The total estimated cost for all signed agreements between pharmacy chains and issuers would be approximately $82,601. The total cost of 1,100 signed agreements between all providers of contraceptive services and issuers would be approximately $9.3 million in the first year. The Departments assume that half of these costs would be incurred by participating providers of contraceptive services and half by issuers (approximately $4.7 million each). Providers of contraceptive services are likely to incorporate these costs into their fees for providing the contraceptive services, while costs to 7263 issuers would be offset by Federal payments in the form of user fee adjustments. The annual costs of renegotiating and signing agreements in future years might be lower, unless providers of contraceptive services enter into new agreements with different issuers. The Departments seek comment on the number of signed agreements that would be executed annually and the magnitude of the potential administrative costs to providers of contraceptive services and issuers. TABLE 2—ANNUAL COSTS RELATED TO SIGNED AGREEMENTS Estimated number of signed agreements khammond on DSKJM1Z7X2PROD with PROPOSALS2 Entities Estimated cost per signed agreement Total estimated cost Clinicians/Facilities and Issuers ................................................................................................... Pharmacies and Issuers .............................................................................................................. 1,090 10 $8,494 8,260 $9,258,138 82,601 Total ...................................................................................................................................... 1,100 ........................ 9,340,739 Participating providers of contraceptive services would also incur administrative costs related to eligibility verification, submission of claims, and document retention. These costs are estimated to be approximately $14.5 million annually and are discussed in detail later in the HHS Paperwork Reduction Act section, section VI.D of this preamble. Participating issuers would also incur administrative costs related to processing of amounts received from participating providers of contraceptive services, and submission of required information to HHS. As mentioned previously in this preamble, HHS proposes to reimburse participating issuers an administrative allowance of 15 percent for administrative costs and margin. Therefore, the estimated administrative costs and margin to issuers would be approximately $10.4 million,166 which would be offset by Federal payments in the form of user fee adjustments. This total includes the estimated approximately $11,866 in costs related to the submission of required information to HHS as detailed later in the HHS Paperwork Reduction Act section, section VI.D of this preamble, and approximately $4.7 million in costs related to signing agreements discussed earlier in this section. Individuals would incur costs associated with finding providers of 166 Estimated total amount = cost of contraceptive services ($49.9 million) + administrative costs to providers of contraceptive services (= $14.5 million + $4.7 million) = $69 million. 15 percent of $69 million = $10.4 million approximately. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 contraceptive services that would be willing to participate in the individual contraceptive arrangement. Some individuals might have to switch providers of contraceptive services if their usual providers of contraceptive services are not willing to participate in the individual contraceptive arrangement. The Departments seek comment on ways to mitigate search costs for eligible individuals and how access to the individual contraceptive arrangement can best be promoted. One option could be to make a list of participating providers publicly available on a public website. The Departments also seek comment on whether making provider information publicly available might deter provider participation in the individual contraceptive arrangement. Additionally, as discussed previously, people of color and low-income people are more likely to live in areas considered contraception deserts. If eligible individuals live in contraception deserts, they might have to spend more time and money traveling longer distances in order to meet with a participating provider of contraceptive services. The Departments seek comment on the number of eligible individuals without access to contraceptive services without cost sharing under their existing plan or coverage or living in contraception deserts and the potential search costs of these proposed rules on such individuals. There would also be a reduction in health care costs for individuals who gain access to contraceptive services PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 and for group health plans and coverage sponsored, arranged, or provided by exempt entities if these proposed rules lead to a reduction in unintended pregnancies or improved health outcomes. Individuals who do not currently have contraceptive coverage through group health plans and coverage sponsored by exempt entities may turn to State-funded programs to obtain contraceptive services. States may also currently incur costs related to unintended pregnancies resulting from a lack of access to contraceptive services for these individuals. These proposed rules may therefore lead to cost savings for states, to the extent that states are currently incurring costs to provide or fund contraceptive services or birth and maternity care for individuals who would gain access to contraceptive services as a result of these proposed rules. The Departments seek comment on the potential impacts of these proposed rules on states and State finances. Transfers These proposed rules would result in a transfer from the Federal Government, via the provision of user fee adjustments to issuers that would then reimburse providers of contraceptive services for the costs of furnishing contraceptive services, to individuals who would now have access to contraceptive services without cost sharing and no longer incur out-of-pocket spending on contraceptive services. As discussed previously in the Number of Affected Entities discussion of this section, it is estimated that at least 126,400 E:\FR\FM\02FEP2.SGM 02FEP2 7264 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules individuals would be eligible to participate in the individual contraceptive arrangement. Based on the limited information available from the 2019 user fee adjustment data,167 the Departments estimate that the average annual cost of contraceptive services for one individual is approximately $395. Therefore, the Departments estimate that the provision of the individual contraceptive arrangement could lead to a transfer from the Federal Government to individuals (via issuers to providers of contraceptive services) of approximately $49.9 million annually.168 This estimate is uncertain due to the limited information available in the 2019 user fee adjustment data, and the Departments seek comment on the estimated average annual cost of contraceptive services per individual. Assuming these proposed regulations are finalized and become applicable during 2023, transfers might be lower in 2023, since 2023 transfers would include services furnished during only part of the year. In addition, a reduction in unintended pregnancies or improved health outcomes could lead to a reduction in premiums. The Departments also expect that the proposed elimination of the exemption for entities and individuals that object to contraceptive coverage based on nonreligious moral beliefs could lead to a transfer from plans and issuers to participants, beneficiaries, and enrollees due to reduced out-of-pocket spending on contraceptive services. However, the Departments do not have information on the number of entities and individuals that have claimed a moral exemption to providing contraceptive coverage and seek comment on the number of entities and individuals that would be affected by this proposed change. khammond on DSKJM1Z7X2PROD with PROPOSALS2 Uncertainty Although the Departments expect that these proposed rules would expand access to contraceptive services without cost sharing, as noted earlier in this section, there are several areas of uncertainty regarding the potential impacts of these proposed rules. The Departments are uncertain how many providers of contraceptive services, issuers, and eligible individuals would participate in the individual contraceptive arrangement. The Departments seek comment on potential barriers that might prevent providers, issuers, and eligible 167 HHS used 2019 data for this estimate to better reflect claims experience outside of the COVID–19 public health emergency. 168 126,400 × $395 = $49.9 million approximately. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 individuals from participating in the individual contraceptive arrangement. The Departments anticipate that the administrative allowance—which would be expected to cover participating issuers’ administrative costs and provide a margin to ensure that participating issuers receive appropriate compensation for providing reimbursements—would incentivize issuers to participate in the individual contraceptive arrangement. The Departments expect that administrative costs incurred by participating providers of contraceptive services to deliver the services would be included in the amounts they submit to issuers for reimbursement (as noted earlier in this section), and therefore would not be a deterrent to participation in the individual contraceptive arrangement. The Departments are unable to estimate these costs precisely because these costs are expected to vary. These costs might be lower for larger providers, due to larger economies of scale, and for providers that might currently have contracts with participating issuers. The Departments are uncertain as to how the number of participating providers might vary (for example, across rural and urban areas) and how this variation might affect access to services under the individual contraceptive arrangement. Due to the lack of data, the Departments are unable to develop a precise estimate of the number of eligible individuals who might participate in the individual contraceptive arrangement because the Departments do not know how many entities have claimed an exemption under the November 2018 Religious Exemption final rules. Further, take-up of the individual contraceptive arrangement by eligible individuals would be affected by, among other things, awareness of the individual contraceptive arrangement, the number of providers of contraceptive services that participate in the individual contraceptive arrangement, and the amount of time and effort it would take an individual to find a participating provider. The Departments are unable to develop a more accurate estimate of the transfers and cost to the Federal Government (discussed earlier in this section) as there is uncertainty regarding the total amounts for contraceptive services that would be submitted by providers of contraceptive services to issuers for reimbursement, and therefore the total amount of the transfer from the Federal Government to eligible individuals, and the total amounts of the administrative costs incurred by PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 participating providers and issuers. Finally, this overall lack of data leads to uncertainty regarding the magnitudes of the total cost savings to eligible individuals and any resulting potential cost savings to states (associated with reduced spending on State-funded programs that provide contraceptive services or a potential reduction in the number of unintended pregnancies that would otherwise impose costs to states). The Departments seek comment on all of these areas of uncertainty regarding the impacts of these proposed rules. C. Regulatory Alternatives In developing these proposed rules, the Departments considered various alternative approaches. The Departments considered maintaining the exemption (along with the existing accommodations and the proposed individual contraceptive arrangement) with respect to group health plans, health insurance issuers, and institutions of higher education that have a non-religious moral objection to contraceptive coverage. The Departments, however, are of the view that neither RFRA nor any other Federal statute compels such an exemption, and propose eliminating this exemption for several reasons, especially given the strong public interest in assuring contraceptive coverage to women enrolled in group health plans, or group or individual (including student) health insurance coverage. With respect to individuals enrolled in coverage through entities that have a religious objection to contraceptive coverage, the Departments considered an approach under which contraceptive coverage would be available through separate individual insurance policies that cover only contraceptives and in which participants, beneficiaries, and enrollees would have to separately enroll if they desired contraceptive coverage. Because separate contraception-only coverage would not comply with the individual market reforms, it would be necessary for the Departments to create, by regulation, a new excepted benefit category for individual contraceptive-only coverage.169 Under this approach, issuers of this coverage would receive FFE or SBE–FP user fee reductions to pay for this coverage, as the issuer generally would not realize offsetting savings in pregnancy-related costs when providing coverage separate from the plan or coverage offered by the objecting entity. If the issuer of this coverage did not participate in the FFE or an SBE–FP, 169 See, for example, section 2791(c)(2)(C) of the PHS Act. E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules it could partner with an FFE or SBE–FP issuer to receive the user fee adjustment. The Departments decided against this option for a number of reasons. The Departments are concerned that issuers would not offer these products to a sufficient extent to ensure access nationwide, as commenters on the July 2016 RFI explained that it would be costly and administratively burdensome for issuers to develop and implement new eligibility, enrollment, and claimsadjudication systems for contraceptiononly coverage, as they would differ from their existing systems. Additionally, some State regulators might not have authority or capacity to approve singlebenefit insurance policies (other than dental or vision or disease-specific excepted benefits policies) within a relatively short period of time after Federal rules would permit these policies. Cost-free contraception policies would also not satisfy some State laws conditioning policy approval on a ‘‘reasonable premium’’ or the existence of valid contracts because the prospective policyholder would not provide consideration in exchange for the coverage. The Departments also considered an approach under which, if an objecting entity designs or contracts for a health plan without contraceptive coverage, the contraceptive coverage requirement would apply directly to the issuer, in the case of a fully insured plan (that is, the issuer would not be exempted from the requirement on the basis of the objecting entity’s objection), or the third party administrator, in the case of a selfinsured plan. The issuer or third party administrator would then be required to fulfill its separate and independent obligation to provide contraceptive coverage, in the same manner as it is required to do so with respect to a nonexempt entity. However, the Departments are of the view that there would not be legal authority for imposing this obligation on a third party administrator. With respect to issuers, the Departments decided to solicit comment on this approach, as further described in section II.C.1 of this preamble. With respect to the proposed changes to 45 CFR 156.50(d), in addition to the proposed submission requirements on the part of the participating issuer, HHS VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 considered whether to condition a provider of contraceptive services’ participation in the individual contraceptive arrangement for eligible individuals on the provider of contraceptive services’ agreement to submit to HHS identifying information for itself and the participating issuer, the total dollar amount of the cost of furnishing contraceptive services pursuant to the individual contraceptive arrangement, and an attestation that the costs for furnishing such services were incurred in compliance with the requirements of the individual contraceptive arrangement. However, HHS is of the view that conditioning participation in the individual contraceptive arrangement on compliance with a separate submission requirement for providers of contraceptive services would create significant additional burden on providers of contraceptive services and could deter participation in the individual contraceptive arrangement, reducing access to contraceptive services for eligible individuals. D. Paperwork Reduction Act— Department of Health and Human Services In addition to an arrangement with a participating issuer on the FFE or an SBE–FP, HHS considered whether to allow a provider of contraceptive services to arrange with a third party administrator to submit documentation to HHS on their behalf under 45 CFR 156.50(d). Under this arrangement, a third party administrator entering into an agreement with a provider of contraceptive services would partner with an FFE or SBE–FP issuer to receive reimbursement for its costs of furnishing contraceptive services and then the third party administrator would pay the provider of contraceptive services. Establishing a direct contractual relationship between providers of contraceptive services and third party administrators was rejected as more administratively complex because providers and third party administrators do not have the same existing contractual agreements to deliver these services as providers and issuers do. In contrast, the proposed approach of direct agreements between providers of contraceptive services and participating issuers on the FFE or an SBE–FP builds upon existing relationships between providers and issuers. 1. Wage Estimates PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 7265 Under the Paperwork Reduction Act of 1995 (PRA), HHS is required to provide 60-days’ notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to OMB for review and approval. To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that HHS solicit comment on the following issues: • The need for the information collection and its usefulness in carrying out the proper functions of the agency. • The accuracy of HHS’ estimate of the information collection burden. • The quality, utility, and clarity of the information to be collected. • Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. HHS generally uses data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for the cost of fringe benefits and other indirect costs) for estimating the burden associated with the information collection requirements (ICRs).170 Table 3 presents the mean hourly wage, the cost of fringe benefits and other indirect costs, and the adjusted hourly wage. As indicated, employee hourly wage estimates have been adjusted by a factor of 100 percent. This is necessarily a rough adjustment, both because the cost of fringe benefits and other indirect costs vary significantly across employers, and because methods of estimating these costs vary widely across studies. Nonetheless, there is no practical alternative, and HHS is of the view that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. 170 See May 2021 Bureau of Labor Statistics, Occupational Employment Statistics, National Occupational Employment and Wage Estimates, available at https://www.bls.gov/oes/current/oes_ nat.htm. E:\FR\FM\02FEP2.SGM 02FEP2 7266 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules TABLE 3—ADJUSTED HOURLY WAGES USED IN BURDEN ESTIMATES Mean hourly wage ($/hour) Cost of fringe benefits and other indirect costs ($/hour) Adjusted hourly wage ($/hour) Occupation title Occupational code All Occupations ............................................... Actuary ............................................................ Insurance Claims and Policy Processing Clerks. Medical Secretaries and Administrative Assistants. 00–0000 ......................................................... 15–2011 ......................................................... 43–9041 ......................................................... $28.01 60.24 22.02 $28.01 60.24 22.02 $56.02 120.48 44.04 43–6013 ......................................................... 19.11 19.11 38.22 2. ICRs Regarding Adjustment of Exchange User Fees—Participating Issuers (45 CFR 156.50(d)(2)) The proposed provisions would require a participating issuer on the FFE or an SBE–FP seeking a user fee adjustment to submit to HHS, in the year following the calendar year in which the contraceptive services for which reimbursement pursuant to the proposed individual contraceptive arrangement were furnished, the following: (A) identifying information for the participating issuer and each provider of contraceptive services with respect to which the participating issuer seeks an adjustment of any user fee; (B) documentation, with respect to each provider of contraceptive services, demonstrating that the participating issuer and provider of contraceptive services have agreed that the participating issuer will seek an adjustment of the user fee to reimburse the provider of contraceptive services for the costs of furnishing contraceptive services; and (C) for each provider of contraceptive services, the total dollar amount of the costs of the contraceptive services that were furnished during the applicable calendar year pursuant to the proposed individual contraceptive arrangement. The proposed amendments also require that a participating issuer on the FFE or an SBE–FP receiving an adjustment to any user fee under 45 CFR 156.50(d) for a particular calendar year must maintain documentation for 10 years demonstrating that it timely paid each provider of contraceptive services, with respect to which it received such adjustment, any amount required under paragraph 45 CFR 156.50(d)(5). Approximately 40 QHP issuers have entered into arrangements with third party administrators under the third party administrator optional accommodation.171 HHS anticipates that all (or some subset) of those issuers that have already entered into arrangements with third party administrators would be most likely to enter into arrangements with providers of contraceptive services because they would already be familiar with the process for seeking a user fee adjustment related to payments for contraceptive services. HHS anticipates there would be an increase in burden associated with these proposed data submission requirements for those issuers that participate in the individual contraceptive arrangement. HHS would collect the required data elements for participating issuers on the FFE or an SBE–FP to receive a user fee adjustment under the proposed individual contraceptive arrangement through the same web form online tool and at the same time as participating issuers complete the data submission process for the third party administrator optional accommodation. HHS previously estimated that for the issuers that enter into arrangements with third party administrators, each issuer needs approximately 3 hours of actuarial work, 5 hours of work by claims and policy processing clerks, 2 hours for legal counsel, and 1 hour for a top executive.172 For issuers that would participate in arrangements with providers of contraceptive services, HHS estimates that each issuer would incur an additional burden of 1 hour of work by an actuary (at $120.48 per hour), and 4 hours of work by claims and policy processing clerks (at $44.04 per hour) including time for recordkeeping. The total additional burden for each issuer would be 5 hours annually, with an equivalent cost of approximately $297. Therefore, if all 40 issuers enter into arrangements with providers of contraceptive services, the total annual burden associated with this requirement would be approximately 200 hours, at a cost of approximately $11,866. These costs would be offset by Federal payments in the form of user fee adjustments. khammond on DSKJM1Z7X2PROD with PROPOSALS2 TABLE 4—ANNUAL BURDEN AND COSTS FOR PARTICIPATING ISSUERS Estimated number of respondents Estimated number of responses Estimated burden per response (hours) Total annual burden (hours) Total estimated cost 40 40 5 200 $11,866 HHS will revise the information collection currently approved under OMB control number 0938–1285 (CMS– 10492), to account for this new burden. 3. ICRs Regarding Adjustment of Exchange User Fees—Participating Providers of Contraceptive Services (45 CFR 156.50(d)(8)) The proposed provisions require that, as a condition of participation in the 171 See 78 FR 39870 at 39875 through 39886 for additional background on the third party administrator optional accommodation. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 172 This burden is currently approved under OMB control number 0938–1285 (CMS–10492, Coverage of Certain Preventive Services Under the Affordable PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 proposed individual contraceptive arrangement, providers of contraceptive services would be required to maintain documentation for 10 years demonstrating that the costs of furnishing contraceptive services were Care Act: Data Submission Requirements to Receive the Federally-facilitated Exchange User Fee Adjustment). E:\FR\FM\02FEP2.SGM 02FEP2 7267 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules made in compliance with the individual contraceptive arrangement, including a representation by (or on behalf of) the individual demonstrating the individual’s eligibility for the individual contraceptive arrangement, and the total dollar amount of the costs of the contraceptive services furnished. As discussed previously in section VI.B.2 of this preamble, HHS estimates that at least 2,180 providers of contraceptive services (1,090 pharmacies, and 1,090 clinicians and facilities), and 126,400 individuals would participate in the individual contraceptive arrangement. Eligible individuals could receive contraceptive services from more than one provider of contraceptive services (1,090 pharmacies, and 1,090 clinicians or facilities). HHS anticipates that eligible individuals would likely receive contraceptive services from more than one provider of contraceptive services (for example, during a visit to a clinician or facility and during a visit to a pharmacy to fill a prescription) and more than once a year. HHS therefore estimates that each provider of contraceptive services would furnish contraceptive services to approximately 116 eligible individuals annually, on average. HHS assumes that a provider of contraceptive services (for example, clinician, facility, or pharmacy) would confirm eligibility for each individual only once annually and submit all claims for all eligible individuals together to the issuer. HHS estimates that for each provider of contraceptive services, a medical secretary would need, on average, approximately 1.5 hours (at $38.22 per hour) to record each representation demonstrating an individual’s eligibility for the individual contraceptive arrangement, calculate and record the costs associated with the contraceptive services furnished throughout the year, submit the amounts to the participating issuer on the FFE or an SBE–FP, and maintain records. The total burden for each provider of contraceptive services would be, on average, 1.5 hours for each individual, with an associated cost of $57.33. For 2,180 providers of contraceptive services, the total burden related to furnishing contraceptive services to 126,400 individuals (assuming each individual receives contraceptive services from 2 providers on average each year) would be 379,200 hours with an associated cost of approximately $14.5 million. These estimates constitute the lower bound, as burden and costs would be higher if the number of eligible individuals is higher, or if eligible individuals see more than two providers of contraceptive services in a year. Providers of contraceptive services would be likely to incorporate these costs into their fees for providing the contraceptive services. TABLE 5—ANNUAL BURDEN AND COSTS FOR PARTICIPATING PROVIDERS OF CONTRACEPTIVE SERVICES Estimated number of respondents Provider or facility type Estimated burden per response (hours) Estimated number of responses Total annual burden (hours) Total estimated cost Clinicians or Facilities .......................................................... Pharmacies .......................................................................... 1,090 1,090 126,400 126,400 1.5 1.5 189,600 189,600 $7,246,512 7,246,512 Total .............................................................................. 2,180 252,800 1.5 379,200 14,493,024 HHS will revise the information collection currently approved under OMB control number 0938–1285 (CMS– 10492), to account for this new burden. 4. ICRs Regarding Confirmation of Eligibility for the Individual Contraceptive Arrangement (45 CFR 147.131(a)(3)(ii)) Individuals could confirm their eligibility for the individual contraceptive arrangement with a provider of contraceptive services by providing a summary of benefits that includes the relevant information provided under the plan, or by providing an attestation. These proposed rules include, in 45 CFR 147.131(d)(2), an example of language that could be used by participants, beneficiaries and enrollees or their authorized representatives to confirm eligibility. The Departments estimate that at least 126,400 individuals would be eligible for the individual contraceptive arrangement and would need to confirm their eligibility, and that each eligible individual would need, on average, 5 minutes (at an equivalent cost of $56.02 per hour) to do so. The total burden for all individuals to confirm their eligibility for the individual contraceptive arrangement to their provider of contraceptive services would be approximately 10,533 hours with an equivalent cost of approximately $590,077. The Departments consider these estimates to be a lower bound, as the total burden and costs would be higher if the number of eligible individuals that take part in the individual contraceptive arrangement is higher. As HHS, DOL, and the Department of the Treasury share jurisdiction, HHS would account for 50 percent of the burden, or approximately 5,267 hours annually, with an equivalent annual cost of $295,039. DOL and the Department of the Treasury would each account for 25 percent of the burden, as discussed in section VI.E of this preamble. khammond on DSKJM1Z7X2PROD with PROPOSALS2 TABLE 6—ANNUAL BURDEN AND COSTS FOR INDIVIDUALS Estimated number of respondents Estimated number of responses Estimated burden per response (hours) Total annual burden (hours) Total estimated cost 63,200 63,200 0.08 5,267 $295,039 VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 E:\FR\FM\02FEP2.SGM 02FEP2 7268 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules HHS will revise the information collection currently approved under OMB control number 0938–1344 (CMS– 10653),173 to account for this new burden. 5. ICRs Regarding the Existing Optional Accommodation for Exempt Entities (45 CFR 147.131(b)) An entity seeking to be treated as an eligible organization for the existing optional accommodation may selfcertify (by using EBSA Form 700), prior to the beginning of the first plan year to which an accommodation is to apply, that it meets the definition of an eligible organization. An eligible organization may submit a notification to HHS as an alternative to submitting the EBSA Form 700 to the eligible organization’s health insurance issuer or third party administrator. The burden related to this optional accommodation is currently approved under OMB Control Number: 0938–1344 (CMS–10653). HHS will revise this information collection to update the EBSA Form 700 and model notice to HHS to reflect the proposal to remove the moral exemption. However, the burden estimates would not be affected by the provisions in these proposed rules as the Departments did not previously expect any entities with nonreligious moral objections to use the existing optional accommodation. 6. ICRs Regarding Notice of Availability of Separate Payments for Contraceptive Services (45 CFR 147.131(c)) A health insurance issuer or third party administrator providing or arranging separate payments for services for participants and beneficiaries in insured plans (or student enrollees and covered dependents in student health insurance coverage) of eligible organizations exercising the existing optional accommodation is required to provide a written notice to the plan participants and beneficiaries (or student enrollees and covered dependents) informing them of the availability of these payments. As discussed previously in section II.D.1 of this preamble, the Departments propose to amend the model language for this notice. The burden related to this notice is currently approved under OMB Control Number: 0938–1344 (CMS– 10653). HHS will revise this information collection to update the model notice to reflect this proposed amendment. The Departments previously estimated that 109 respondents will incur an annual burden of 136.25 hours with an equivalent cost of approximately $7,000, and materials and mailing cost of approximately $358,000 annually to comply with this ICR. The burden and cost estimates would not be affected by the proposed change in model language for the notice. 7. Summary of Annual Burden Estimates for Proposed Information Collection Requirements TABLE 7—ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS OMB control No. Regulation section 45 CFR § 156.50(d)(2) ............. 45 CFR § 156.50(d)(8) ............. 45 CFR § 147.131(a)(3)(ii) ....... khammond on DSKJM1Z7X2PROD with PROPOSALS2 Total .................................. Respondents Responses Burden per response (hours) Total annual burden (hours) Total cost 40 2,180 63,200 40 252,800 63,200 5 1.5 0.08 200 379,200 5,267 $59.33 38.22 56.02 $11,866 14,493,024 295,039 $11,866 14,493,024 295,039 .................... 65,420 63,200 .................. 384,667 .................. 14,799,928 14,799,928 ICR-related comments are due April 3, 2023. HHS has submitted a copy of these proposed rules to OMB for its review of the rule’s information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB. To obtain copies of the supporting statement and any related forms for the proposed collections, please visit CMS’s website at https://www.cms.gov/ Regulations-and-Guidance/Legislation/ PaperworkReductionActof1995/PRAListing. HHS invites public comments on these potential information collection requirements. If you wish to comment, please submit your comments electronically as specified in the ADDRESSES section of these proposed rules and identify the rule (CMS–9903– P), the ICR’s CFR citation, CMS ID number, and OMB control number. E. Paperwork Reduction Act— Department of Labor and Department of the Treasury 173 OMB Control Number: 0938–1344 (CMS– 10653, Coverage of Certain Preventive Services Under the Affordable Care Act). 18:46 Feb 01, 2023 Total labor cost of reporting 0938–1285 0938–1285 0938–1285 8. Submission of PRA-Related Comments VerDate Sep<11>2014 Average hourly labor cost of reporting Jkt 259001 As part of their continuing effort to reduce paperwork and respondent burden, the Department of Labor and the Department of the Treasury conduct a preclearance consultation program to allow the general public and Federal agencies to comment on proposed and continuing collections of information in accordance with the PRA.174 This helps to ensure that the public understands the Departments’ collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Departments can properly assess the 174 44 PO 00000 impact of collection requirements on respondents. Currently, the Department of Labor and the Department of the Treasury are soliciting comments concerning the proposed information collection request (ICR) included in the Coverage of Certain Preventive Services under the Affordable Care Act—Private Sector. To obtain a copy of the ICR, contact the PRA addressee shown below or go to https://www.RegInfo.gov. The Departments have submitted a copy of these proposed rule to OMB in accordance with 44 U.S.C. 3507(d) for review of its information collections. The Departments and OMB are particularly interested in comments that: • Evaluate whether the collection of information is necessary for the functions of the agency, including whether the information will have practical utility; U.S.C. 3506(c)(2)(A) (1995). Frm 00034 Fmt 4701 Sfmt 4702 E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules khammond on DSKJM1Z7X2PROD with PROPOSALS2 • Evaluate the accuracy of the agency’s estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected and minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (for example, permitting electronically delivered responses). Commenters may send their views on the Departments’ PRA analysis in the same way they send comments in response to the proposed rule as a whole (for example, through the www.regulations.gov website), including as part of a comment responding to the broader proposed rule. Comments are due by April 3, 2023 to ensure their consideration. PRA Addressee: Address requests for copies of the ICR to James Butikofer, Office of Research and Analysis, U.S. Department of Labor, Employee Benefits Security Administration, 200 Constitution Avenue NW, Room N– 5718, Washington, DC 20210; or send to ebsa.opr@dol.gov. 1. ICRs Regarding Confirmation of Eligibility for the Individual Contraceptive Arrangement (26 CFR 54.9815–2713A(a)(3)(iii), 29 CFR 2590.715–2713A(a)(3)(iii)) Individuals could confirm their eligibility for the individual contraceptive arrangement with a provider of contraceptive services by providing a summary of benefits that includes the relevant information provided under the plan, or by providing an attestation. The Departments propose, in 26 CFR 54.9815–2713A(a)(3)(iii) and 29 CFR 2590.715–2713A(a)(3)(iii), an example of language that could be used by participants, beneficiaries, and enrollees or their authorized representatives to confirm eligibility. The Departments estimate that at least 126,400 individuals would be eligible for the individual contraceptive arrangement and would need to confirm their eligibility, and that each eligible individual would need, on average, 5 minutes (at an equivalent cost of $68.96 per hour) to do so. The total burden for all individuals to confirm their eligibility for the individual contraceptive arrangement to their provider of contraceptive services would be approximately 10,533 hours with an equivalent cost of VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 approximately $726,356. The Departments consider these estimates to be a lower bound, as the total burden and costs would be higher if the number of eligible individuals that take part in the individual contraceptive arrangement is higher. As HHS, DOL, and the Department of the Treasury share jurisdiction, HHS would account for 50 percent of the burden, as discussed in section VI.D of this preamble and DOL and the Department of the Treasury would each account for 25 percent of the burden, or approximately 2,633 hours annually with an equivalent annual cost of $181,572. The burden related to the confirmation of eligibility for the individual contraceptive arrangement will be included under OMB Control Number: 1210–0150 (Coverage of Certain Preventive Services under the Affordable Care Act—Private Sector). The information collection has a current expiration date of November 30, 2024. 2. ICRs Regarding the Existing Optional Accommodation for Exempt Entities (26 CFR 54.9815–2713A, 29 CFR 2590.715– 2713A) An entity seeking to be treated as an eligible organization for the existing optional accommodation may selfcertify (by using EBSA Form 700), prior to the beginning of the first plan year to which an accommodation is to apply, that it meets the definition of an eligible organization. An eligible organization may submit a notification to HHS as an alternative to submitting the EBSA Form 700 to the eligible organization’s health insurance issuer or third party administrator. The burden related to this optional accommodation is currently approved under OMB Control Number: 1210–0150 (Coverage of Certain Preventive Services under the Affordable Care Act—Private Sector). The Departments will revise this information collection to update the EBSA Form 700 and model notice to HHS to reflect the proposal to remove the moral exemption. However, the burden estimates would not be affected by the provisions in these proposed rules, as the Departments did not previously expect entities with nonreligious moral objections to use the existing optional accommodation. The information collection has a current expiration date of November 30, 2024. 3. ICRs Regarding Notice of Availability of Separate Payments for Contraceptive Services (26 CFR 54.9815–2713A, 29 CFR 2590.715–2713A) A health insurance issuer or third party administrator providing or PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 7269 arranging separate payments for contraceptive services for participants and beneficiaries in insured plans (or student enrollees and covered dependents in student health insurance coverage) of eligible organizations exercising the existing optional accommodation is required to provide a written notice to such plan participants and beneficiaries (or such student enrollees and covered dependents) informing them of the availability of such payments. The Departments propose to amend the model language for this notice. The burden related to this notice is currently approved under OMB Control Number: 1210–0150 (Coverage of Certain Preventive Services under the Affordable Care Act—Private Sector). The Departments will revise this information collection to update the model notice to reflect this proposed amendment. The Departments previously estimated that 109 respondents will incur an annual burden of 136.25 hours with an equivalent cost of approximately $7,000, and materials and mailing cost of approximately $358,000 annually to comply with this ICR. The burden and cost estimates would not be affected by the proposed change in model language for the notice. The information collection has a current expiration date of November 30, 2024. 4. Summary of Annual Burden Estimates for Proposed Information Collection Requirements A summary of paperwork burden estimates follows: Type of Review: Revision. Agency: Employees Benefits Security Administration, U.S. Department of Labor. Title: Coverage of Certain Preventive Services under the Affordable Care Act—Private Sector. OMB Control Number: 1210–0150. Affected Public: Individuals and households, Businesses or other forprofits, Not-for-profit institutions. Estimated Number of Respondents: 31,630. Estimated Number of Annual Responses: 329,255. Frequency of Response: Annual. Estimated Total Annual Burden Hours: 2,669. Estimated Total Annual Burden Cost: $80,873. Agency: Internal Revenue Service, Department of the Treasury. Title: Coverage of Certain Preventive Services under the Affordable Care Act—Private Sector. OMB Control Number: 1545–NEW. Affected Public: Individuals and households, Businesses or other forprofits, Not-for-profit institutions. E:\FR\FM\02FEP2.SGM 02FEP2 7270 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules Estimated Number of Respondents: 31,630. Estimated Number of Annual Responses: 329,255. Frequency of Response: Annual. Estimated Total Annual Burden Hours: 2,669. Estimated Total Annual Burden Cost: $80,873. khammond on DSKJM1Z7X2PROD with PROPOSALS2 F. Regulatory Flexibility Act The Regulatory Flexibility Act, (5 U.S.C. 601, et seq.), requires agencies to prepare an initial regulatory flexibility analysis to describe the impact of proposed rules on small entities, unless the head of the agency can certify that the rules will not have a significant economic impact on a substantial number of small entities. The RFA generally defines a ‘‘small entity’’ as (1) a proprietary firm meeting the size standards of the Small Business Administration (SBA), (2) a not-forprofit organization that is not dominant in its field, or (3) a small government jurisdiction with a population of less than 50,000. States and individuals are not included in the definition of ‘‘small entity.’’ The Departments use a change in revenues of more than 3 to 5 percent as its measure of significant economic impact on a substantial number of small entities. The provisions in these proposed rules would affect health insurance issuers and providers that furnish contraceptive services (including clinicians, facilities, and pharmacies). Health insurance issuers would be classified under the North American Industry Classification System (NAICS) code 524114 (Direct Health and Medical Insurance Carriers). According to SBA size standards, 175 entities with average annual receipts of $41.5 million or less are considered small entities for this NAICS code. Issuers could possibly be classified in 621491 (HMO Medical Centers) and, if this is the case, the SBA size standard would be $39 million or less. The Departments expect that few, if any, insurance companies underwriting comprehensive health insurance policies (in contrast, for example, to travel insurance policies or dental discount policies) fall below these size thresholds. Based on data from medical loss ratio (MLR) annual report 176 submissions for the 2020 MLR reporting year, approximately 78 out of 481 issuers of health insurance coverage nationwide had total premium revenue of $41.5 million or less. This estimate 175 https://www.sba.gov/document/support-table-size-standards, as of October 2022. 176 Available at https://www.cms.gov/CCIIO/ Resources/Data-Resources/mlr.html. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 may overstate the actual number of small health insurance companies that may be affected, since over 72 percent of these small companies belong to larger holding groups, and many, if not all, of these small companies are likely to have non-health lines of business that will result in their revenues exceeding $41.5 million. In addition, costs incurred by issuers would be offset by Federal payments in the form of user fee adjustments. Clinicians and facilities would be classified under either NAICS code 621111 (Offices of Physicians) with a size standard of $14 million or less or NAICS code 621399 (Offices of All Other Miscellaneous Health Practitioners) with a size standard of $9 million or less. Facilities could also be classified under NAICS code 621410 (Family Planning Centers), with a size standard of $16.5 million or less. The Departments estimate that approximately 1,090 clinicians and facilities would participate in the individual contraceptive arrangement and would incur costs related to signing agreements with participating issuers, eligibility verification, and recordkeeping. Most, if not all, participating clinicians and facilities might be considered small entities. As discussed earlier in section VI.D of this preamble, these costs per clinician or facility are estimated to be approximately $10,895 annually 177 and would likely be accounted for in amounts submitted to participating issuers for reimbursement by the Federal Government. The Departments assume that clinicians or facilities would not participate in the individual contraceptive arrangement if it results in a decline in their revenues or profitability. Pharmacies would be classified under NAICS code 446110 (Pharmacies and Drug Stores) with a size standard of $30 million or less. The Departments assume that 10 pharmacy chains would participate in the individual contraceptive arrangement and would incur costs related to signing agreements with participating issuers, eligibility verification, and recordkeeping. As discussed earlier in section VI.D of this preamble, these costs per pharmacy chain are estimated to be approximately $728,781 annually.178 These costs 177 Total administrative costs for 1,090 clinicians and facilities = $4,629,069 in administrative costs for signed agreements + $7,246,512 in administrative costs related to providing contraceptive services = $11,875,581. Average administrative costs for each clinician or facility = $10,895. 178 Total administrative costs for 10 pharmacy chains = $41,300 in administrative costs for signed PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 would likely be accounted for in amounts submitted to participating issuers for reimbursement by the Federal Government. The major pharmacy chains would not fall below this size threshold. The Departments assume that independent pharmacies or small pharmacy chains would not participate in the individual contraceptive arrangement if it results in a decline in their revenues or profitability. Therefore, the Departments do not anticipate that participation in the individual contraceptive arrangement would have a significant effect on a substantial number of small entities. The Departments seek comment on this analysis. In addition, section 1102(b) of the Social Security Act requires HHS to prepare a regulatory impact analysis if a rule may have a significant economic impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. This rule is not subject to section 1102 of the Social Security Act, HHS does not expect that these proposed rules would have a significant economic impact on the operations of a substantial number of small rural hospitals. Some providers of contraceptive services might be affiliated with small rural hospitals, and these providers might choose to participate in the individual contraceptive arrangement and therefore incur related costs, which would ultimately be reimbursed by the Federal Government. G. Unfunded Mandates Reform Act Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a proposed rule or any final rule for which a general notice of proposed rulemaking was published that includes any Federal mandate that may result in expenditures in any 1 year by State, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2022, that threshold is approximately $165 million. As discussed earlier in section VI of this preamble, providers of contraceptive services and issuers that choose to participate in the individual contraceptive arrangement would incur costs to comply with the proposed provisions of these proposed rules, agreements + $7,246,512 in administrative costs related to providing contraceptive services = $7,287,812. Average administrative costs for each pharmacy chain = $728,781. E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules which would likely be reimbursed and ultimately incurred by the Federal Government. The Departments estimate the combined impact on State, local, or Tribal governments and the private sector would not be above the threshold. H. Federalism Executive Order 13132 outlines fundamental principles of federalism. It requires adherence to specific criteria by Federal agencies in formulating and implementing policies that have ‘‘substantial direct effects’’ on the states, the relationship between the national government and states, or on the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must consult with State and local officials and describe the extent of their consultation and the nature of the concerns of State and local officials in the preamble to the proposed rules. The Departments do not anticipate that these proposed rules would have any federalism implications or limit the policy making discretion of the states, in compliance with the requirement of Executive Order 13132. While developing this rule, the Departments attempted to balance the states’ interests in regulating health insurance issuers with the need to ensure market stability. By doing so, the Departments complied with the requirements of Executive Order 13132. List of Subjects 26 CFR Part 54 Excise taxes, Health care, Health insurance, Pensions, Reporting and recordkeeping requirements. khammond on DSKJM1Z7X2PROD with PROPOSALS2 29 CFR Part 2590 Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements. 45 CFR Part 147 Aged, Citizenship and naturalization, Civil rights, Health care, Health insurance, Individuals with disabilities, Intergovernmental relations, Reporting and recordkeeping requirements, Sex discrimination. 45 CFR Part 156 Administrative practice and procedure, Advertising, Advisory committees, Aged, Alaska, Brokers, Citizenship and naturalization, Civil rights, Conflicts of interests, Consumer protection, Grant programs-health, Grants administration, Health care, VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 Health insurance, Health maintenance organizations (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Intergovernmental relations, Loan programs-health, Medicaid, Organization and functions (Government agencies), Prescription drugs, Public assistance programs, Reporting and recordkeeping requirements, Sex discrimination, State and local governments, Sunshine Act, Technical assistance, Women, Youth. DEPARTMENT OF THE TREASURY Internal Revenue Service Accordingly, the Treasury Department and the IRS propose to amend 26 CFR part 54 as follows: PART 54—PENSION EXCISE TAXES Paragraph 1.The authority citation for part 54 continues to read as follows: ■ Authority: 26 U.S.C. 7805 * * * Par 2. Section 54.9815–2713 is amended by revising paragraphs (a)(1) introductory text and (a)(1)(iv) to read as follows: ■ § 54.9815–2713 Coverage of preventive health services. (a) * * * (1) In general. Beginning at the time described in paragraph (b) of this section, a group health plan, or a health insurance issuer offering group health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for— * * * * * (iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in evidence-informed comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to 45 CFR 147.131 and 147.132. * * * * * ■ Par 3. Section 54.9815–2713A is revised to read as follows: § 54.9815–2713A Alternate availability of certain preventive health services. (a) Organizations eligible for optional accommodations and individuals eligible for individual contraceptive arrangements. (1) An eligible organization is an organization that meets the criteria of paragraphs (a)(1)(i) through (iii) of this section. (i) The organization is an objecting entity described in 45 CFR 147.132(a)(1)(i) through (iii); PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 7271 (ii) Notwithstanding its exempt status under 45 CFR 147.132(a), the organization voluntarily seeks to be considered an eligible organization to invoke the optional accommodation under paragraph (b) or (c) of this section; and (iii) The organization self-certifies in the form and manner specified by the Secretary of Labor or provides notice to the Secretary of Health and Human Services as described in paragraph (b) or (c) of this section. To qualify as an eligible organization, the organization must make such self-certification or notice available for examination upon request by the first day of the first plan year to which the accommodation in paragraph (b) or (c) of this section applies. The self-certification or notice must be executed by a person authorized to make the certification or provide the notice on behalf of the organization and must be maintained in a manner consistent with the record retention requirements under section 107 of ERISA. (2) An eligible organization may revoke its use of the accommodation under paragraph (b) or (c) of this section, and its issuer or third party administrator must provide participants and beneficiaries written notice of the revocation; the eligible organization’s revocation of the accommodation will 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. (3) An eligible individual is an individual who— (i) Is a participant or beneficiary enrolled in a group health plan established or maintained by an objecting entity described in 45 CFR 147.132(a) that, to the extent eligible, has not invoked the optional accommodation under paragraph (b) or (c) of this section; and (ii) Confirms (such as by making an attestation) to a provider of contraceptive services that agrees to meet the conditions in paragraph (d)(1) of this section that the individual is enrolled in a group health plan or group health insurance coverage that does not provide coverage for all or a subset of contraceptive services as generally required under § 54.9815–2713(a)(1)(iv). (b) Optional accommodation—selfinsured group health plans. (1) A group health plan established or maintained by an eligible organization that provides benefits on a self-insured basis may voluntarily elect an optional accommodation under which its third party administrator(s) will provide or arrange payments for all or a subset of contraceptive services for one or more E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7272 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules plan years. To invoke the optional accommodation process: (i) Except as provided in paragraph (b)(5) of this section, the eligible organization or its plan must contract with one or more third party administrators. (ii) The eligible organization must provide either a copy of the selfcertification to each third party administrator it contracts with to provide administrative services in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its objection as described in 45 CFR 147.132 to coverage of all or a subset of contraceptive services. (A) When a copy of the selfcertification is provided directly to a third party administrator, the selfcertification must include a notice that obligations of the third party administrator are set forth in in 29 CFR 2510.3–16 and this section. (B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services the eligible organization objects to covering, if applicable), but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is student health insurance coverage within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of section 414(e) or section 3(33) of ERISA); and the name and contact information for any of the plan’s third party administrators. If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of Health and Human Services for the optional accommodation process to remain in effect. The Department of Labor (working with the Department of Health and Human Services) will send a separate notification to each of the plan’s third party administrators informing the third party administrator that the Secretary of Health and Human Services has received a notice under paragraph (b)(1)(ii) of this section and describing the obligations of the third party administrator under 29 CFR 2510.3–16(c) and this section. (2) If a third party administrator receives a copy of the self-certification from an eligible organization or a notification from the Department of Labor, as described in paragraph VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 (b)(1)(ii) of this section and is willing to enter into or remain in a contractual relationship with the eligible organization or its plan to provide administrative services for the plan, then the third party administrator will provide or arrange payments for contraceptive services, using one of the following methods— (i) Provide payments for the contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries; or (ii) Arrange for an issuer or other entity to provide payments for contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. (3) If a third party administrator provides or arranges payments for contraceptive services in accordance with either paragraph (b)(2)(i) or (ii) of this section, the costs of providing or arranging such payments may be reimbursed through an adjustment to the Federally-facilitated Exchange or State Exchange on the Federal platform user fees for a participating issuer pursuant to 45 CFR 156.50(d). (4) A third party administrator may not require any documentation other than a copy of the self-certification from the eligible organization or notification from the Department of Labor described in paragraph (b)(1)(ii) of this section. (5) Where an otherwise eligible organization does not contract with a third party administrator and it files a self-certification or notice under paragraph (b)(1)(ii) of this section, the obligations under paragraph (b)(2) of this section do not apply, and the otherwise eligible organization is not required to provide coverage or payments for contraceptive services to which it objects. The plan administrator for that otherwise eligible organization may, if it and the otherwise eligible organization choose, arrange for payments for contraceptive services from an issuer or other entity in accordance with paragraph (b)(2)(ii) of this section, and such issuer or other entity may receive reimbursements in accordance with paragraph (b)(3) of this section. PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 (6) Where an otherwise eligible organization is a church plan within the meaning of section 3(33) of ERISA or section 414(e) and it files a selfcertification or notice under paragraph (b)(1)(ii) of this section, the obligations under paragraph (b)(2) of this section do not apply, and the otherwise eligible organization is under no requirement to provide coverage or payments for contraceptive services to which it objects. The third party administrator for that otherwise eligible organization may, if it and the otherwise eligible organization choose, provide or arrange payments for contraceptive services in accordance with paragraph (b)(2)(i) or (ii) of this section, and receive reimbursements in accordance with paragraph (b)(3) of this section. (c) Optional accommodation— insured group health plans—(1) A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers may voluntarily elect an optional accommodation under which its health insurance issuer(s) will provide payments for all or a subset of contraceptive services for one or more plan years. To invoke the optional accommodation process: (i) The eligible organization or its plan must contract with one or more health insurance issuers. (ii) The eligible organization must provide either a copy of the selfcertification to each issuer it contracts with to provide coverage in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its objection as described in 45 CFR 147.132 to coverage for all or a subset of contraceptive services. (A) When a copy of the selfcertification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 54.9815– 2713(a)(1)(iv). (B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable), but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is student health insurance coverage within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules section 414(e) or section 3(33) of ERISA); and the name and contact information for any of the plan’s health insurance issuers. If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of Health and Human Services for the optional accommodation to remain in effect. The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the issuer that the Secretary of Health and Human Services has received a notice under paragraph (c)(1)(ii) of this section and describing the obligations of the issuer under this section. (2) If an issuer receives a copy of the self-certification from an eligible organization or the notification from the Department of Health and Human Services as described in paragraph (c)(1)(ii) of this section and does not have an objection as described in 45 CFR 147.132 to providing the contraceptive services identified in the self-certification or the notification from the Department of Health and Human Services, the issuer will provide payments for contraceptive services as follows— (i) The issuer must expressly exclude contraceptive coverage from the group health insurance coverage provided in connection with the group health plan and provide separate payments for any contraceptive services required to be covered under § 54.9815–2713(a)(1)(iv) for plan participants and beneficiaries for so long as they remain enrolled in the plan. (ii) With respect to payments for contraceptive services, the issuer may not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. The issuer must segregate premium revenue collected from the eligible organization from the monies used to provide payments for contraceptive services. The issuer must provide payments for contraceptive services in a manner that is consistent with the requirements under sections 2706, 2709, 2711, 2713, and 2719 of the PHS Act, as incorporated into section 9815, and section 9822. If the group health plan of the eligible organization provides coverage for some but not all of any contraceptive services required to be covered under § 54.9815– 2713(a)(1)(iv), the issuer is required to provide payments only for those VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 contraceptive services for which the group health plan does not provide coverage. However, the issuer may provide payments for all contraceptive services at the issuer’s option. (3) A health insurance issuer may not require any documentation other than a copy of the self-certification from the eligible organization or the notification from the Department of Health and Human Services described in paragraph (c)(1)(ii) of this section. (d) Notice of availability of separate payments for contraceptive services— self-insured and insured group health plans. For each plan year to which the optional accommodation in paragraph (b) or (c) of this section is to apply, a third party administrator required to provide or arrange payments for contraceptive services pursuant to paragraph (b) of this section, and an issuer required to provide payments for contraceptive services pursuant to paragraph (c) of this section, must provide to plan participants and beneficiaries written notice of the availability of separate payments for contraceptive services contemporaneous with (to the extent possible), but separate from, any application materials distributed in connection with enrollment (or re-enrollment) in group health coverage that is effective beginning on the first day of each applicable plan year. The notice must specify that the eligible organization does not administer or fund contraceptive benefits, but that the third party administrator or issuer, as applicable, provides or arranges separate payments for contraceptive services, and must provide contact information for questions and complaints. The following model language, or substantially similar language, may be used to satisfy the notice requirement of this paragraph (d): ‘‘Your employer has certified that your group health plan qualifies for an accommodation with respect to the Federal requirement to cover contraceptive services for women, including all Food and Drug Administration-approved, cleared, or granted contraceptives, as prescribed by a health care provider, without cost sharing. This means that your employer will not contract, arrange, pay, or refer for contraceptive coverage. Instead, [name of third party administrator/ health insurance issuer] will provide separate payments for contraceptive services that you use, without cost sharing and at no other cost, for so long as you are enrolled in your group health plan. Your employer will not administer or fund these payments. If you have any questions about this notice, contact PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 7273 [contact information for third party administrator/health insurance issuer].’’ (e) Individual contraceptive arrangements for eligible individuals. (1) An eligible individual may elect an individual contraceptive arrangement under which a willing provider of contraceptive services furnishes the eligible individual with contraceptive services that a group health plan or health insurance issuer would have been required to cover pursuant to § 54.9815–2713(a)(1)(iv), if not for the plan’s or issuer’s exempt status under 45 CFR 147.132(a). Under this individual contraceptive arrangement, the willing provider of contraceptive services must furnish contraceptive services (including items and services that are integral to the furnishing of the contraceptive services) to the eligible individual without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof, except that the provider of contraceptive services may seek payment from, and be reimbursed by, an issuer for the costs of providing the items and services through an adjustment to the issuer’s Federally-facilitated Exchange or State Exchange on the Federal platform user fees pursuant to 45 CFR 156.50(d). (2) The following language may, but is not required to, be used by a participant or beneficiary (or an authorized representative of a participant or beneficiary) to confirm to a provider of contraceptive services that the plan or coverage is sponsored, provided, or arranged by an objecting entity and does not provide coverage for all or a subset of contraceptive services as generally required under § 54.9815–2713(a)(1)(iv): ‘‘I certify that I am enrolled (or am an authorized representative of a person who is enrolled) in an employersponsored health plan or health insurance coverage that does not provide coverage for all or a subset of contraceptive services as generally required under the Affordable Care Act.’’ A participant or beneficiary (or an authorized representative of a participant or beneficiary) may use other means to confirm to a provider of contraceptive services that the plan or coverage is sponsored, provided, or arranged by an objecting entity and does not provide coverage for all or a subset of contraceptive services. (f) Reliance—insured group health plans. (1) If an issuer reasonably and in good faith relies on a representation by an eligible organization indicating that the organization is eligible for the accommodation in paragraph (c) of this section, and the representation is later E:\FR\FM\02FEP2.SGM 02FEP2 7274 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules determined to be incorrect, the issuer is considered to comply with any applicable requirement under § 54.9815–2713(a)(1)(iv) to provide contraceptive coverage if the issuer complies with the obligations under this section applicable to such issuer. (2) A group health plan is considered to comply with any applicable requirement under § 54.9815– 2713(a)(1)(iv) to provide contraceptive coverage if the plan complies with its obligations under paragraph (c) of this section, without regard to whether the issuer complies with the obligations under this section applicable to such issuer. (g) Definitions. (1) For the purposes of this section, reference to ‘‘contraceptive’’ services, benefits, or coverage includes contraceptive or sterilization items, procedures, or services, or related patient education or counseling, to the extent specified for purposes of § 54.9815–2713(a)(1)(iv). (2) For the purposes of this section, the term ‘‘provider of contraceptive services’’ means any health care provider (including a clinician, pharmacy, or other facility) acting within the scope of that provider’s license, certification, or authority under applicable law to provide contraceptive services (as defined in paragraph (g)(1) of this section). (h) Severability. Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. DEPARTMENT OF LABOR khammond on DSKJM1Z7X2PROD with PROPOSALS2 Employee Benefits Security Administration For the reasons stated in the preamble, the Department of Labor proposes to amend 29 CFR part 2590 as set forth below: PART 2590—RULES AND REGULATIONS FOR GROUP HEALTH PLANS 4. The authority citation for part 2590 continues to read as follows: ■ Authority: 29 U.S.C. 1027, 1059, 1135, 1161–1168, 1169, 1181–1183, 1181 note, 1185, 1185a–n, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Pub. L.104–191, 110 Stat. 1936; sec. 401(b), Pub. L. 105–200, 112 Stat. VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110–343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111–148, 124 Stat. 119, as amended by Pub. L. 111–152, 124 Stat. 1029; Division M, Pub. L. 113–235, 128 Stat. 2130; Pub. L. 116–260 134 Stat. 1182; Secretary of Labor’s Order 1–2011, 77 FR 1088 (Jan. 9, 2012). 5. Section 2590.715–2713 is amended by revising paragraphs (a)(1) introductory text and (a)(1)(iv) to read as follows: ■ § 2590.715–2713 health services. Coverage of preventive (a) * * * (1) In general. Beginning at the time described in paragraph (b) of this section, a group health plan, or a health insurance issuer offering group health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for— * * * * * (iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in evidence-informed comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to 45 CFR 147.131 and 147.132; and * * * * * ■ 6. Section 2590.715–2713A is revised to read as follows: § 2590.715–2713A Alternate availability of certain preventive health services. (a) Organizations eligible for optional accommodations and individuals eligible for individual contraceptive arrangements. (1) An eligible organization is an organization that meets the criteria of paragraphs (a)(1)(i) through (iii) of this section. (i) The organization is an objecting entity described in 45 CFR 147.132(a)(1)(i) through (iii); (ii) Notwithstanding its exempt status under 45 CFR 147.132(a), the organization voluntarily seeks to be considered an eligible organization to invoke the optional accommodation under paragraph (b) or (c) of this section; and (iii) The organization self-certifies in the form and manner specified by the Secretary or provides notice to the Secretary of Health and Human Services as described in paragraph (b) or (c) of this section. To qualify as an eligible organization, the organization must make such self-certification or notice available for examination upon request PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 by the first day of the first plan year to which the accommodation in paragraph (b) or (c) of this section applies. The self-certification or notice must be executed by a person authorized to make the certification or provide the notice on behalf of the organization and must be maintained in a manner consistent with the record retention requirements under section 107 of ERISA. (2) An eligible organization may revoke its use of the accommodation under paragraph (b) or (c) of this section, and its issuer or third party administrator must provide participants and beneficiaries written notice of the revocation; the eligible organization’s revocation of the accommodation will 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. (3) An eligible individual is an individual who— (i) Is a participant or beneficiary enrolled in a group health plan established or maintained by an objecting entity described in 45 CFR 147.132(a) that, to the extent eligible, has not invoked the optional accommodation under paragraph (b) or (c) of this section; and (ii) Confirms (such as by making an attestation) to a provider of contraceptive services that agrees to meet the conditions in paragraph (d)(1) of this section that the individual is enrolled in a group health plan or group health insurance coverage that does not provide coverage for all or a subset of contraceptive services as generally required under § 2590.715– 2713(a)(1)(iv). (b) Optional accommodation—selfinsured group health plans. (1) A group health plan established or maintained by an eligible organization that provides benefits on a self-insured basis may voluntarily elect an optional accommodation under which its third party administrator(s) will provide or arrange payments for all or a subset of contraceptive services for one or more plan years. To invoke the optional accommodation process: (i) Except as provided in paragraph (b)(5) of this section, the eligible organization or its plan must contract with one or more third party administrators. (ii) The eligible organization must provide either a copy of the selfcertification to each third party administrator it contracts with to provide administrative services in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules organization and of its objection as described in 45 CFR 147.132 to coverage of all or a subset of contraceptive services. (A) When a copy of the selfcertification is provided directly to a third party administrator, the selfcertification must include a notice that obligations of the third party administrator are set forth in § 2510.3– 16 of this chapter and this section. (B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services the eligible organization objects to covering, if applicable), but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is student health insurance coverage within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of section 414(e) of the Internal Revenue Code or section 3(33) of ERISA); and the name and contact information for any of the plan’s third party administrators. If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of Health and Human Services for the optional accommodation process to remain in effect. The Department of Labor (working with the Department of Health and Human Services) will send a separate notification to each of the plan’s third party administrators informing the third party administrator that the Secretary of Health and Human Services has received a notice under paragraph (b)(1)(ii) of this section and describing the obligations of the third party administrator under § 2510.3– 16(c) of this chapter and this section. (2) If a third party administrator receives a copy of the self-certification from an eligible organization or a notification from the Department of Labor, as described in paragraph (b)(1)(ii) of this section and is willing to enter into or remain in a contractual relationship with the eligible organization or its plan to provide administrative services for the plan, then the third party administrator will provide or arrange payments for contraceptive services, using one of the following methods— (i) Provide payments for the contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries; or (ii) Arrange for an issuer or other entity to provide payments for contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. (3) If a third party administrator provides or arranges payments for contraceptive services in accordance with either paragraph (b)(2)(i) or (ii) of this section, the costs of providing or arranging such payments may be reimbursed through an adjustment to the Federally-facilitated Exchange or State Exchange on the Federal platform user fees for a participating issuer pursuant to 45 CFR 156.50(d). (4) A third party administrator may not require any documentation other than a copy of the self-certification from the eligible organization or notification from the Department of Labor described in paragraph (b)(1)(ii) of this section. (5) Where an otherwise eligible organization does not contract with a third party administrator and it files a self-certification or notice under paragraph (b)(1)(ii) of this section, the obligations under paragraph (b)(2) of this section do not apply, and the otherwise eligible organization is not required to provide coverage or payments for contraceptive services to which it objects. The plan administrator for that otherwise eligible organization may, if it and the otherwise eligible organization choose, arrange for payments for contraceptive services from an issuer or other entity in accordance with paragraph (b)(2)(ii) of this section, and such issuer or other entity may receive reimbursements in accordance with paragraph (b)(3) of this section. (c) Optional accommodation— insured group health plans. (1) A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers may voluntarily elect an optional accommodation under which its health insurance issuer(s) will provide payments for all or a subset of contraceptive services for one or more plan years. To invoke the optional accommodation process: PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 7275 (i) The eligible organization or its plan must contract with one or more health insurance issuers. (ii) The eligible organization must provide either a copy of the selfcertification to each issuer it contracts with to provide coverage in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its objection as described in 45 CFR 147.132 to coverage for all or a subset of contraceptive services. (A) When a copy of the selfcertification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 2590.715– 2713(a)(1)(iv). (B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable), but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is student health insurance coverage within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of section 414(e) of the Internal Revenue Code or section 3(33) of ERISA); and the name and contact information for any of the plan’s health insurance issuers. If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of Health and Human Services for the optional accommodation to remain in effect. The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the issuer that the Secretary of Health and Human Services has received a notice under paragraph (c)(1)(ii) of this section and describing the obligations of the issuer under this section. (2) If an issuer receives a copy of the self-certification from an eligible organization or the notification from the Department of Health and Human Services as described in paragraph (c)(1)(ii) of this section and does not have an objection as described in 45 CFR 147.132 to providing the contraceptive services identified in the self-certification or the notification from the Department of Health and Human Services, the issuer will provide E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7276 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules payments for contraceptive services as follows— (i) The issuer must expressly exclude contraceptive coverage from the group health insurance coverage provided in connection with the group health plan and provide separate payments for any contraceptive services required to be covered under § 2590.715–2713(a)(1)(iv) for plan participants and beneficiaries for so long as they remain enrolled in the plan. (ii) With respect to payments for contraceptive services, the issuer may not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. The issuer must segregate premium revenue collected from the eligible organization from the monies used to provide payments for contraceptive services. The issuer must provide payments for contraceptive services in a manner that is consistent with the requirements under sections 2706, 2709, 2711, 2713, and 2719 of the PHS Act, as incorporated into section 715 of ERISA, and section 722 of ERISA. If the group health plan of the eligible organization provides coverage for some but not all of any contraceptive services required to be covered under § 2590.715–2713(a)(1)(iv), the issuer is required to provide payments only for those contraceptive services for which the group health plan does not provide coverage. However, the issuer may provide payments for all contraceptive services at the issuer’s option. (3) A health insurance issuer may not require any documentation other than a copy of the self-certification from the eligible organization or the notification from the Department of Health and Human Services described in paragraph (c)(1)(ii) of this section. (d) Notice of availability of separate payments for contraceptive services— self-insured and insured group health plans. For each plan year to which the optional accommodation in paragraph (b) or (c) of this section is to apply, a third party administrator required to provide or arrange payments for contraceptive services pursuant to paragraph (b) of this section, and an issuer required to provide payments for contraceptive services pursuant to paragraph (c) of this section, must provide to plan participants and beneficiaries written notice of the availability of separate payments for contraceptive services contemporaneous with (to the extent possible), but separate from, any application materials VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 distributed in connection with enrollment (or re-enrollment) in group health coverage that is effective beginning on the first day of each applicable plan year. The notice must specify that the eligible organization does not administer or fund contraceptive benefits, but that the third party administrator or issuer, as applicable, provides or arranges separate payments for contraceptive services, and must provide contact information for questions and complaints. The following model language, or substantially similar language, may be used to satisfy the notice requirement of this paragraph (d): ‘‘Your employer has certified that your group health plan qualifies for an accommodation with respect to the Federal requirement to cover contraceptive services for women, including all Food and Drug Administration-approved, cleared, or granted contraceptives, as prescribed by a health care provider, without cost sharing. This means that your employer will not contract, arrange, pay, or refer for contraceptive coverage. Instead, [name of third party administrator/ health insurance issuer] will provide separate payments for contraceptive services that you use, without cost sharing and at no other cost, for so long as you are enrolled in your group health plan. Your employer will not administer or fund these payments. If you have any questions about this notice, contact [contact information for third party administrator/health insurance issuer].’’ (e) Individual contraceptive arrangements for eligible individuals. (1) An eligible individual may elect an individual contraceptive arrangement under which a willing provider of contraceptive services furnishes the eligible individual with contraceptive services that a group health plan or health insurance issuer would have been required to cover pursuant to § 2590.715–2713(a)(1)(iv), if not for the plan’s or issuer’s exempt status under 45 CFR 147.132(a). Under this individual contraceptive arrangement, the willing provider of contraceptive services must furnish contraceptive services (including items and services that are integral to the furnishing of the contraceptive services) to the eligible individual without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof, except that the provider of contraceptive services may seek payment from, and be reimbursed by, an issuer for the costs of providing the items and services PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 through an adjustment to the issuer’s Federally-facilitated Exchange or State Exchange on the Federal platform user fees pursuant to 45 CFR 156.50(d). (2) The following language may, but is not required to, be used by a participant or beneficiary (or an authorized representative of a participant or beneficiary) to confirm to a provider of contraceptive services that the plan or coverage is sponsored, provided, or arranged by an objecting entity and does not provide coverage for all or a subset of contraceptive services as generally required under § 2590.715– 2713(a)(1)(iv): ‘‘I certify that I am enrolled (or am an authorized representative of a person who is enrolled) in an employer-sponsored health plan or health insurance coverage that does not provide coverage for all or a subset of contraceptive services as generally required under the Affordable Care Act.’’ A participant or beneficiary (or an authorized representative of a participant or beneficiary) may use other means to confirm to a provider of contraceptive services that the plan or coverage is sponsored, provided, or arranged by an objecting entity and does not provide coverage for all or a subset of contraceptive services. (f) Reliance—insured group health plans. (1) If an issuer reasonably and in good faith relies on a representation by an eligible organization indicating that the organization is eligible for the accommodation in paragraph (c) of this section, and the representation is later determined to be incorrect, the issuer is considered to comply with any applicable requirement under § 2590.715–2713(a)(1)(iv) to provide contraceptive coverage if the issuer complies with the obligations under this section applicable to such issuer. (2) A group health plan is considered to comply with any applicable requirement under § 2590.715– 2713(a)(1)(iv) to provide contraceptive coverage if the plan complies with its obligations under paragraph (c) of this section, without regard to whether the issuer complies with the obligations under this section applicable to such issuer. (g) Definitions. (1) For the purposes of this section, reference to ‘‘contraceptive’’ services, benefits, or coverage includes contraceptive or sterilization items, procedures, or services, or related patient education or counseling, to the extent specified for purposes of § 2590.715–2713(a)(1)(iv). (2) For the purposes of this section, the term ‘‘provider of contraceptive services’’ means any health care provider (including a clinician, pharmacy, or other facility) acting E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules within the scope of that provider’s license, certification, or authority under applicable law to provide contraceptive services (as defined in paragraph (g)(1) of this section). (h) Severability. Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. DEPARTMENT OF HEALTH AND HUMAN SERVICES For the reasons stated in the preamble, the Department of Health and Human Services proposes to amend 45 CFR parts 147 and 156 as set forth below: PART 147—HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS 7. The authority citation for part 147 continues to read as follows: ■ Authority: 42 U.S.C. 300gg through 300gg– 63, 300gg–91, 300gg–92, and 300gg–111 through 300gg–139, as amended, and section 3203, Pub. L. 116–136, 134 Stat. 281. 8. Section 147.130 is amended by revising paragraphs (a)(1) introductory text and (a)(1)(iv) to read as follows: ■ khammond on DSKJM1Z7X2PROD with PROPOSALS2 § 147.130 services. Coverage of preventive health (a) * * * (1) In general. Beginning at the time described in paragraph (b) of this section, a group health plan, or a health insurance issuer offering group or individual health insurance coverage, must provide coverage for and must not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible) for— * * * * * (iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in evidence-informed comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to §§ 147.131 and 147.132; and * * * * * ■ 9. Section 147.131 is revised to read as follows: VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 § 147.131 Alternate availability of certain preventive health services. (a) Organizations eligible for optional accommodations and individuals eligible for individual contraceptive arrangements. (1) An eligible organization is an organization that meets the criteria of paragraphs (a)(1)(i) through (iii) of this section. (i) The organization is an objecting entity described in § 147.132(a)(1)(i) through (iii); (ii) Notwithstanding its exempt status under § 147.132(a), the organization voluntarily seeks to be considered an eligible organization to invoke the optional accommodation under paragraph (b) of this section; and (iii) The organization self-certifies in the form and manner specified by the Secretary of Health and Human Services or provides notice to the Secretary of Health and Human Services as described in paragraph (b) of this section. To qualify as an eligible organization, the organization must make such self-certification or notice available for examination upon request by the first day of the first plan year to which the accommodation in paragraph (b) of this section applies. The selfcertification or notice must be executed by a person authorized to make the certification or provide the notice on behalf of the organization and must be maintained in a manner consistent with the record retention requirements under section 107 of ERISA. (2) An eligible organization may revoke its use of the accommodation under paragraph (b) of this section, and its issuer must provide participants and beneficiaries written notice of the revocation; the eligible organization’s revocation of the accommodation will 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. (3) An eligible individual is an individual who— (i) Is a participant or beneficiary enrolled in a group health plan established or maintained, or an enrollee in individual health insurance coverage offered or arranged, by an objecting entity described in § 147.132(a) that, to the extent eligible, has not invoked the optional accommodation under paragraph (b) of this section; and (ii) Confirms (such as by making an attestation) to a provider of contraceptive services that agrees to meet the conditions in paragraph (d)(1) of this section that the individual is enrolled in a group health plan or group or individual health insurance coverage that does not provide coverage for all or PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 7277 a subset of contraceptive services as generally required under § 147.130(a)(1)(iv). (b) Optional accommodation— insured group health plans. (1) A group health plan established or maintained by an eligible organization that provides benefits through one or more group health insurance issuers may voluntarily elect an optional accommodation under which its health insurance issuer(s) will provide payments for all or a subset of contraceptive services for one or more plan years. To invoke the optional accommodation process: (i) The eligible organization or its plan must contract with one or more health insurance issuers. (ii) The eligible organization must provide either a copy of the selfcertification to each issuer it contracts with to provide coverage in connection with the plan or a notice to the Secretary of Health and Human Services that it is an eligible organization and of its objection as described in § 147.132 to coverage for all or a subset of contraceptive services. (A) When a copy of the selfcertification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 147.130(a)(1)(iv). (B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in § 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable), but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is student health insurance coverage within the meaning of § 147.145(a) or a church plan within the meaning of section 3(33) of ERISA or section 414(e) of the Internal Revenue Code); and the name and contact information for any of the plan’s health insurance issuers. If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of Health and Human Services for the optional accommodation to remain in effect. The Department of Health and Human Services will send a separate notification to each of the plan’s health insurance issuers informing the issuer that the Secretary of Health and Human Services has received a notice under paragraph (b)(1)(ii) of this section and E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7278 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules describing the obligations of the issuer under this section. (2) If an issuer receives a copy of the self-certification from an eligible organization or the notification from the Department of Health and Human Services as described in paragraph (b)(1)(ii) of this section and does not have an objection as described in § 147.132 to providing the contraceptive services identified in the selfcertification or the notification from the Department of Health and Human Services, the issuer will provide payments for contraceptive services as follows— (i) The issuer must expressly exclude contraceptive coverage from the group health insurance coverage provided in connection with the group health plan and provide separate payments for any contraceptive services required to be covered under § 147.130(a)(1)(iv) for plan participants and beneficiaries for so long as they remain enrolled in the plan. (ii) With respect to payments for contraceptive services, the issuer may not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. The issuer must segregate premium revenue collected from the eligible organization from the monies used to provide payments for contraceptive services. The issuer must provide payments for contraceptive services in a manner that is consistent with the requirements under sections 2706, 2709, 2711, 2713, 2719, and 2799A–7 of the PHS Act. If the group health plan of the eligible organization provides coverage for some but not all of any contraceptive services required to be covered under § 147.130(a)(1)(iv), the issuer is required to provide payments only for those contraceptive services for which the group health plan does not provide coverage. However, the issuer may provide payments for all contraceptive services at the issuer’s option. (3) A health insurance issuer may not require any documentation other than a copy of the self-certification from the eligible organization or the notification from the Department of Health and Human Services described in paragraph (b)(1)(ii) of this section. (c) Notice of availability of separate payments for contraceptive services— insured group health plans and student health insurance coverage. For each plan year to which the optional accommodation in paragraph (b) of this VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 section is to apply, an issuer required to provide payments for contraceptive services pursuant to paragraph (b) of this section must provide to plan participants and beneficiaries written notice of the availability of separate payments for contraceptive services contemporaneous with (to the extent possible), but separate from, any application materials distributed in connection with enrollment (or reenrollment) in group health coverage that is effective beginning on the first day of each applicable plan year. The notice must specify that the eligible organization does not administer or fund contraceptive benefits, but that the issuer provides separate payments for contraceptive services, and must provide contact information for questions and complaints. The following model language, or substantially similar language, may be used to satisfy the notice requirement of this paragraph (c): ‘‘Your [employer/ institution of higher education] has certified that your [group health plan/ student health insurance coverage] qualifies for an accommodation with respect to the Federal requirement to cover contraceptive services for women, including all Food and Drug Administration-approved, cleared, or granted contraceptives, as prescribed by a health care provider, without cost sharing. This means that your [employer/institution of higher education] will not contract, arrange, pay, or refer for contraceptive coverage. Instead, [name of health insurance issuer] will provide separate payments for contraceptive services that you use, without cost sharing and at no other cost, for so long as you are enrolled in your [group health plan/student health insurance coverage]. Your [employer/ institution of higher education] will not administer or fund these payments. If you have any questions about this notice, contact [contact information for health insurance issuer].’’ (d) Individual contraceptive arrangements for eligible individuals. (1) An eligible individual may elect an individual contraceptive arrangement under which a willing provider of contraceptive services furnishes the eligible individual with contraceptive services that a group health plan or health insurance issuer would have been required to cover pursuant to § 147.130(a)(1)(iv), if not for the plan’s or issuer’s exempt status under § 147.132(a). Under this individual contraceptive arrangement, the willing provider of contraceptive services must furnish contraceptive services (including items and services that are PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 integral to the furnishing of the contraceptive services) to the eligible individual without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof, except that the provider of contraceptive services may seek payment from, and be reimbursed by, an issuer for the costs of providing the items and services through an adjustment to the issuer’s federally-facilitated Exchange or State Exchange on the Federal platform user fees pursuant to § 156.50(d) of this subchapter. (2) The following language may, but is not required to, be used by a participant, beneficiary, or enrollee (or an authorized representative of a participant, beneficiary, or enrollee) to confirm to a provider of contraceptive services that the plan or coverage is sponsored, provided, or arranged by an objecting entity and does not provide coverage for all or a subset of contraceptive services as generally required under § 147.130(a)(1)(iv): ‘‘I certify that I am enrolled (or am an authorized representative of a person who is enrolled) in an employersponsored health plan or individual health insurance coverage that does not provide coverage for all or a subset of contraceptive services as generally required under the Affordable Care Act.’’ A participant, beneficiary, or enrollee (or an authorized representative of a participant, beneficiary, or enrollee) may use other means to confirm to a provider of contraceptive services that the plan or coverage is sponsored, provided, or arranged by an objecting entity and does not provide coverage for all or a subset of contraceptive services. (e) Reliance. (1) If an issuer reasonably and in good faith relies on a representation by an eligible organization indicating that the organization is eligible for the accommodation in paragraph (b) of this section, and the representation is later determined to be incorrect, the issuer is considered to comply with any applicable requirement under § 147.130(a)(1)(iv) to provide contraceptive coverage if the issuer complies with the obligations under this section applicable to such issuer. (2) A group health plan is considered to comply with any applicable requirement under § 147.130(a)(1)(iv) to provide contraceptive coverage if the plan complies with its obligations under paragraph (b) of this section, without regard to whether the issuer complies with the obligations under this section applicable to such issuer. E:\FR\FM\02FEP2.SGM 02FEP2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules (f) Rule of construction. In the case of student health insurance coverage, this section is applicable in the same manner as it is applicable to group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor that is an employer, and references to ‘‘plan participants and beneficiaries’’ will be interpreted as references to student enrollees and their covered dependents. (g) Definitions. (1) For the purposes of this section, reference to ‘‘contraceptive’’ services, benefits, or coverage includes contraceptive or sterilization items, procedures, or services, or related patient education or counseling, to the extent specified for purposes of § 147.130(a)(1)(iv). (2) For the purposes of this section, the term ‘‘provider of contraceptive services’’ means any health care provider (including a clinician, pharmacy, or other facility) acting within the scope of that provider’s license, certification, or authority under applicable law to provide contraceptive services (as defined in paragraph (g)(1) of this section). (h) Severability. Any provision of this section held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, shall be construed so as to continue to give maximum effect to the provision permitted by law, unless such holding shall be one of utter invalidity or unenforceability, in which event the provision shall be severable from this section and shall not affect the remainder thereof or the application of the provision to persons not similarly situated or to dissimilar circumstances. ■ 10. Section 147.132 is amended by revising paragraphs (a)(1)(i) introductory text, (a)(1)(iv), and (b) to read as follows: khammond on DSKJM1Z7X2PROD with PROPOSALS2 § 147.132 Religious exemptions in connection with coverage of certain preventive health services. (a) * * * (1) * * * (i) A group health plan and health insurance coverage provided in connection with a group health plan, to the extent the non-governmental sponsor of the plan or coverage objects as specified in paragraph (a)(2) of this section. Such non-governmental plan sponsors include the following entities— * * * * * (iv) A health insurance issuer offering group or individual health insurance coverage to the extent the issuer objects as specified in paragraph (a)(2) of this section. Where a health insurance issuer VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 providing group health insurance coverage is exempt under this paragraph (a)(1)(iv), the group health plan established or maintained by the plan sponsor with which the health insurance issuer contracts remains subject to any requirement to provide coverage for contraceptive services under guidelines issued under § 147.130(a)(1)(iv) unless it is also exempt from that requirement. Notwithstanding §§ 146.150 of this subchapter and 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 under paragraph (a) or (b) of this section, respectively. * * * * * (b) Objecting individuals. (1) Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services Administration must not provide for or support the requirement of coverage or payments for contraceptive services with respect to an individual who objects to coverage or payments for some or all contraceptive services based on sincerely held religious beliefs. Thus, the following entities will be exempt from any Health Resources and Services Administration guidelines requirements that relate to the provision of contraceptive services with respect to such an individual: (i) A health insurance issuer offering group or individual health insurance coverage willing to provide the plan sponsor (with respect to the individual) or individual, as applicable, with a separate policy, certificate, or contract of insurance; or (ii) A group health plan willing to provide the individual a separate group health plan or benefit package option. (2) For purposes of this paragraph (b), if an individual objects to some but not all contraceptive services and the issuer, to the extent permitted by applicable State law, and the plan sponsor, as applicable, are 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. * * * * * § 147.133 ■ [Removed] 11. Section 147.133 is removed. PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 7279 PART 156—HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES 12. The authority citation for part 156 continues to read as follows: ■ Authority: 42 U.S.C. 18021–18024, 18031– 18032, 18041–18042, 18044, 18054, 18061, 18063, 18071, 18082, and 26 U.S.C. 36B. 13. Section 156.50 is amended in paragraph (a) by adding the definition of ‘‘provider of contraceptive services’’ in alphabetical order and revising paragraph (d) to read as follows: ■ § 156.50 Financial support. (a) * * * Provider of contraceptive services has the meaning given to the term in § 147.131(g)(2) of this subchapter. * * * * * (d) Adjustment of Exchange user fees. (1) A participating issuer offering a plan through a Federally-facilitated Exchange or State Exchange on the Federal platform may qualify for an adjustment of the federally-facilitated Exchange user fee specified in paragraph (c)(1) of this section or the State Exchange on the Federal platform user fee specified in paragraph (c)(2) of this section, to the extent that the participating issuer— (i) Made payments for contraceptive services on behalf of a third party administrator pursuant to 26 CFR 54.9815–2713A(b)(2)(ii) or 29 CFR 2590.715–2713A(b)(2)(ii); (ii) Seeks an adjustment in the Federally-facilitated Exchange user fee or State Exchange on the Federal platform user fee with respect to a third party administrator that, following receipt of a copy of the self-certification referenced in 26 CFR 54.9815– 2713A(a)(1)(iii) or 29 CFR 2590.715– 2713A(a)(1)(iii), made or arranged for payments for contraceptive services pursuant to 26 CFR 54.9815– 2713A(b)(2)(i) or (ii) or 29 CFR 2590.715–2713A(b)(2)(i) or (ii); or (iii) Seeks an adjustment in the federally-facilitated Exchange user fee or State Exchange on the Federal platform user fee with respect to a provider of contraceptive services that, following receipt of a representation by or on behalf of an individual that the individual is an eligible individual (as defined in 26 CFR 54.9815–2713A(a)(3), 29 CFR 2590.715–2713A(a)(3), or § 147.131(a)(3) of this subchapter), furnished contraceptive services to the eligible individual, without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 7280 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules and services or any portion thereof pursuant to 26 CFR 54.9815–2713A(e), 29 CFR 2590.715–2713A(e), or § 147.131(d) of this subchapter. (2) For a participating issuer described in paragraph (d)(1) of this section to receive an adjustment of a user fee under this section— (i) The participating issuer must submit to HHS, in the manner and timeframe specified by HHS, in the year immediately following the calendar year in which the contraceptive services for which payments pursuant to 26 CFR 54.9815–2713A(b)(2) or (e), 29 CFR 2590.715–2713A(b)(2) or (e), or § 147.131(d) of this subchapter were provided— (A) Identifying information for the participating issuer and each third party administrator that received a copy of the self-certification referenced in 26 CFR 54.9815–2713A(a)(1)(iii) or 29 CFR 2590.715–2713A(a)(1)(iii), whether or not the participating issuer was the entity that made the payments for contraceptive services, and each provider of contraceptive services that furnished contraceptive services in compliance with 26 CFR 54.9815– 2713A(e), 29 CFR 2590.715–2713A(e), or 45 CFR 147.131(d) to an eligible individual (as defined in 26 CFR 54.9815–2713A(a)(3), 29 CFR 2590.715– 2713A(a)(3), or § 147.131(a)(3) of this subchapter), with respect to which the participating issuer seeks an adjustment of the user fee specified in paragraph (c)(1) or (2) of this section, as applicable; (B) Identifying information for each self-insured group health plan with respect to which a copy of the selfcertification referenced in 26 CFR 54.9815–2713A(a)(1)(iii) or 29 CFR 2590.715–2713A(a)(1)(iii) was received by a third party administrator, and with respect to which the participating issuer seeks an adjustment of the user fee specified in paragraph (c)(1) or (2) of this section, as applicable; (C) For each such self-insured group health plan, the total dollar amount of the payments that were made pursuant to 26 CFR 54.9815–2713A(b)(2) or 29 CFR 2590.715–2713A(b)(2) for contraceptive services that were provided during the applicable calendar year. If such payments were made by the participating issuer directly as described in paragraph (d)(1)(i) of this section, the total dollar amount should reflect the amount of the payments made by the participating issuer; if the third party administrator made or arranged for such payments, as described in paragraph (d)(1)(ii) of this section, the total dollar amount should reflect the amount reported to the VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 participating issuer by the third party administrator; (D) Documentation, with respect to each provider of contraceptive services, demonstrating that the participating issuer and the provider of contraceptive services have a signed written agreement providing that the participating issuer will reimburse (or has reimbursed) the provider of contraceptive services for the costs of furnishing contraceptive services during the applicable calendar year in compliance with 26 CFR 54.9815– 2713A(e), 29 CFR 2590.715–2713A(e), or § 147.131(d) of this subchapter, and will seek an adjustment of the user fee specified in paragraph (c)(1) or (2) of this section as a result of the agreement to reimburse the provider’s costs under 26 CFR 54.9815–2713A(e), 29 CFR 2590.715–2713A(e), or § 147.131(d) of this subchapter; and (E) For each provider of contraceptive services as specified in paragraph (d)(2)(i)(A) of this section, the total dollar amount of the costs of furnishing contraceptive services during the applicable calendar year pursuant to 26 CFR 54.9815–2713A(e), 29 CFR 2590.715–2713A(e), or § 147.131(d) of this subchapter. (ii) Each third party administrator that intends to seek an adjustment on behalf of a participating issuer of the Federallyfacilitated Exchange user fee or the State-based Exchange on the Federal platform user fee based on payments for contraceptive services, must submit to HHS a notification of such intent, in a manner specified by HHS, by the 60th calendar day following the date on which the third party administrator receives the applicable copy of the selfcertification referenced in 26 CFR 54.9815–2713A(a)(1)(iii) or 29 CFR 2590.715–2713A(a)(1)(iii). (iii) Each third party administrator identified in paragraph (d)(2)(i)(A) of this section must submit to HHS, in the manner and timeframe specified by HHS, in the year following the calendar year in which the contraceptive services for which payments were made pursuant to 26 CFR 54.9815– 2713A(b)(2) or 29 CFR 2590.715– 2713A(b)(2) were provided— (A) Identifying information for the third party administrator and the participating issuer; (B) Identifying information for each self-insured group health plan with respect to which a copy of the selfcertification referenced in 26 CFR 54.9815–2713A(a)(1)(iii) or 29 CFR 2590.715–2713A(a)(1)(iii) was received by the third party administrator and with respect to which the participating issuer seeks an adjustment of the user PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 fee specified in paragraph (c)(1) or (2) of this section, as applicable; (C) The total number of participants and beneficiaries in each such selfinsured group health plan during the applicable calendar year; and (D) For each such self-insured group health plan with respect to which the third party administrator made payments pursuant to 26 CFR 54.9815– 2713A(b)(2) or 29 CFR 2590.715– 2713A(b)(2) for contraceptive services, the total dollar amount of such payments that were provided during the applicable calendar year. If such payments were made by the participating issuer directly as described in paragraph (d)(1)(i) of this section, the total dollar amount should reflect the amount reported to the third party administrator by the participating issuer; if the third party administrator made or arranged for such payments, as described in paragraph (d)(1)(ii) of this section, the total dollar amount should reflect the amount of the payments made by or on behalf of the third party administrator. (E) An attestation that the payments for contraceptive services were made in compliance with 26 CFR 54.9815– 2713A(b)(2) or 29 CFR 2590.715– 2713A(b)(2). (3) If the requirements set forth in paragraph (d)(2) of this section are met, the participating issuer will be provided a reduction in its obligation to pay the user fee specified in paragraph (c)(1) or (2) of this section, as applicable, equal in value to the sum of the following: (i) The total dollar amount of the payments for contraceptive services submitted by the applicable third party administrators, as described in paragraph (d)(2)(iii)(D) of this section; (ii) The total dollar amount of the costs of furnishing contraceptive services submitted by the participating issuer on behalf of applicable providers of contraceptive services, described in paragraph (d)(2)(i)(E) of this section; and (iii) An allowance for administrative costs and margin. The allowance will be no less than 10 percent of the total dollar amount of the payments for contraceptive services and the costs of furnishing contraceptive services specified in paragraphs (d)(3)(i) and (d)(3)(ii) of this section. Unless a new allowance is specified for an applicable year in the HHS notice of benefit and payment parameters or other rulemaking, HHS will maintain the allowance that was last specified in rulemaking. (4) If the amount of the adjustment under paragraph (d)(3) of this section is greater than the amount of the participating issuer’s obligation to pay E:\FR\FM\02FEP2.SGM 02FEP2 khammond on DSKJM1Z7X2PROD with PROPOSALS2 Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / Proposed Rules the user fee specified in paragraph (c)(1) or (2) of this section, as applicable, in a particular month, the participating issuer will be provided a credit in succeeding months in the amount of the excess. (5) The participating issuer may reimburse each third party administrator and provider of contraceptive services for payments for contraceptive services submitted by the third party administrator or the provider of contraceptive services’ costs of furnishing contraceptive services, as described in paragraphs (d)(2)(iii)(D) and (d)(2)(i)(E) of this section, as soon as the services are delivered. The participating issuer must pay, within 60 days of receipt of any adjustment of a user fee under this section, each third party administrator and provider of contraceptive services with respect to which it received any portion of such adjustment an amount that is no less than the portion of the adjustment attributable to the total dollar amount of the payments for services submitted by the third party administrator or the provider of contraceptive services’ costs of furnishing contraceptive services, as described in paragraphs (d)(2)(iii)(D) and (d)(2)(i)(E) of this section. No payment to a third administrator or provider of contraceptive services is required with respect to the allowance for administrative costs and margin described in paragraph (d)(3)(iii) of this section. This paragraph does not apply if the participating issuer made the payments for contraceptive services on behalf of the third party administrator, as described in paragraph (d)(1)(i) of this section, or is in the same issuer group as the third party administrator. (6) A participating issuer that receives an adjustment in the user fee specified in paragraph (c)(1) or (2) of this section for a particular calendar year must maintain for 10 years following that year, and make available upon request to HHS, the Office of the Inspector General, the Comptroller General, and their designees, documentation demonstrating that it timely paid each third party administrator and provider with respect to which it received any such adjustment any amount required to be paid to the third party administrator or provider under paragraph (d)(5) of this section. (7) A third party administrator of a plan with respect to which an adjustment of the user fee specified in paragraph (c)(1) or (2) of this section is VerDate Sep<11>2014 18:46 Feb 01, 2023 Jkt 259001 received under this section for a particular calendar year must maintain for 10 years following that year, and make available upon request to HHS, the Office of the Inspector General, the Comptroller General, and their designees, all of the following documentation: (i) A copy of the self-certification referenced in 26 CFR 54.9815– 2713A(a)(1)(iii) or 29 CFR 2590.715– 2713A(a)(1)(iii) for each self-insured plan with respect to which an adjustment is received. (ii) Documentation demonstrating that the payments for contraceptive services were made in compliance with 26 CFR 54.9815–2713A(b)(2) or 29 CFR 2590.715–2713A(b)(2). (iii) Documentation supporting the total dollar amount of the payments for contraceptive services submitted by the third party administrator, as described in paragraph (d)(2)(iii)(D) of this section. (8) A provider of contraceptive services that has furnished contraceptive services in compliance with the individual contraceptive arrangement, with respect to which a participating issuer received an adjustment of the user fee specified in paragraph (c)(1) or (2) of this section for a particular calendar year must, as a condition of participating in the individual contraceptive arrangement, maintain for 10 years following the contraceptive service being provided, and make available upon request to HHS, the Office of the Inspector General, the Comptroller General, and their designees, all of the following documentation: (i) Documentation demonstrating that the provider of contraceptive services furnished contraceptive services in compliance with 26 CFR 54.9815– 2713A(e), 29 CFR 2590.715–2713A(e), or § 147.131(d) of this subchapter. (ii) Documentation supporting the total dollar amount of the costs of furnishing contraceptive services submitted by the provider of contraceptive services under paragraph (d)(2)(i)(E) of this section. (9) If a provider of contraceptive services relies reasonably and in good faith on a representation by or on behalf of an individual that the individual is an eligible individual (as defined in 26 CFR 54.9815–2713A(a)(3), 29 CFR 2590.715–2713A(a)(3), or § 147.131(a)(3) of this subchapter), and the representation is later determined to be incorrect, the provider of contraceptive PO 00000 Frm 00047 Fmt 4701 Sfmt 9990 7281 services is considered to comply with the applicable requirements under paragraphs (d)(1)(iii), (d)(2)(i)(A), and (d)(8)(i) of this section. (10) If a participating issuer relies reasonably and in good faith on a representation by a provider of contraceptive services that the provider of contraceptive services furnished contraceptive services to an eligible individual (as defined in 26 CFR 54.9815–2713A(a)(3), 29 CFR 2590.715– 2713A(a)(3), or § 147.131(a)(3) of this subchapter), without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof, and the representation that the provider of contraceptive services received from or on behalf of the individual is later determined to be incorrect, the participating issuer is considered to comply with the applicable requirements under paragraphs (d)(1)(iii) and (d)(2)(i)(A) of this section. (11) If a participating issuer relies reasonably and in good faith on a representation by a provider of contraceptive services that the provider of contraceptive services furnished contraceptive services to an eligible individual (as defined in 26 CFR 54.9815–2713A(a)(3), 29 CFR 2590.715– 2713A(a)(3), or § 147.131(a)(3) of this subchapter), without imposing a fee or charge of any kind, directly or indirectly, on the eligible individual or any other entity for the cost of the items and services or any portion thereof, and the representation by the provider of contraceptive services is determined to be incorrect after the participating issuer has paid the provider of contraceptive services the amount described in (d)(2)(i)(E) of this section, the participating issuer is considered to comply with the applicable requirements under paragraphs (d)(1)(iii) and (d)(2)(i)(A) of this section. Melanie R. Krause, Acting Deputy Commissioner for Services and Enforcement, Internal Revenue Service. Lisa M. Gomez, Assistant Secretary, Employee Benefits Security Administration, Department of Labor. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2023–01981 Filed 1–30–23; 11:15 am] BILLING CODE 4150–28–P E:\FR\FM\02FEP2.SGM 02FEP2

Agencies

[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Proposed Rules]
[Pages 7236-7281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01981]



[[Page 7235]]

Vol. 88

Thursday,

No. 22

February 2, 2023

Part IV





Department of the Treasury





-----------------------------------------------------------------------





Internal Revenue Service





-----------------------------------------------------------------------





26 CFR Part 54





Department of Labor





-----------------------------------------------------------------------





Employee Benefits Security Administration





-----------------------------------------------------------------------

29 CFR Part 2590





Department of Health and Human Services





-----------------------------------------------------------------------

45 CFR Parts 147 and 156





Coverage of Certain Preventive Services Under the Affordable Care Act; 
Proposed Rule

Federal Register / Vol. 88, No. 22 / Thursday, February 2, 2023 / 
Proposed Rules

[[Page 7236]]


-----------------------------------------------------------------------

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):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-9903-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-9903-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Jason Sandoval, Internal Revenue 
Service, Department of the Treasury, at (202) 317-5500; Beth Baum or 
Matthew Meidell, Employee Benefits Security Administration, Department 
of Labor, at (202) 693-8335; David Mlawsky, Centers for Medicare & 
Medicaid Services, Department of Health and Human Services, at (410) 
786-6851; for matters related to financial support, Allison Yadsko, 
Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, at (410) 786-1740.
    Customer Service Information: Individuals interested in obtaining 
information from the Department of Labor (DOL) concerning employment-
based health coverage laws may call the Employee Benefits Security 
Administration (EBSA) Toll-Free Hotline at 1-866-444-EBSA (3272) or 
visit the DOL's website (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.

[[Page 7237]]

    Section 2713 of the PHS Act, as added by the ACA and incorporated 
into ERISA and the Code, requires non-grandfathered group health plans 
and health insurance issuers offering non-grandfathered group or 
individual health insurance coverage to provide coverage of certain 
specified preventive services without cost sharing, including, under 
section 2713(a)(4) of the PHS Act, benefits for certain women's 
preventive health services as provided for in comprehensive guidelines 
supported by the Health Resources and Services Administration 
(HRSA).^{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.\3\ As relevant 
here, the 2011 HRSA-Supported Guidelines included sterilization 
procedures, patient education and counseling for women with 
reproductive capacity, and all Food and Drug Administration (FDA)-
approved, cleared, or granted contraceptives, as prescribed by a health 
care provider (collectively, contraceptive services).\4\ Except as 
discussed later in this section, non-grandfathered group health plans 
and health insurance issuers offering non-grandfathered group or 
individual health insurance coverage were required to provide coverage 
consistent with the 2011 HRSA-Supported Guidelines, without cost 
sharing, for plan years (or, in the individual market, policy years) 
beginning on or after August 1, 2012. As fully discussed in footnote 4 
of this preamble, the 2011 HRSA-Supported Guidelines have been updated 
several times; plans and issuers are currently required to provide 
coverage without cost sharing consistent with the HRSA-Supported 
Guidelines as amended in 2019.
---------------------------------------------------------------------------

    \1\ In addition to the specified preventive services addressed 
in section 2713 of the PHS Act, section 3203 of the Coronavirus Aid, 
Relief, and Economic Security Act (CARES Act), enacted on March 27, 
2020, requires non-grandfathered group health plans and health 
insurance issuers offering non-grandfathered group or individual 
health insurance to cover any qualifying coronavirus preventive 
service without cost sharing, pursuant to section 2713(a) of the PHS 
Act (including the regulations under 26 CFR 54.9815-2713, 29 CFR 
2590.715-2713, and 45 CFR 147.130 (or any successor regulations)).
    \2\ The final regulations generally provide that plans and 
issuers must cover a preventive service pursuant to a new or changed 
recommendation starting with the first plan year (or, in the 
individual market, policy year) that begins on or after the date 
that is one year after the date on which the new recommendation is 
issued. 26 CFR 54.9815-2713(b)(1); 29 CFR 2590.715-2713(b)(1); 45 
CFR 147.130(b)(1). Coverage of qualifying coronavirus preventive 
services must begin on an expedited timeline. Public Law 116-136, 
3203, 134 Stat. 367 (2020); 26 CFR 54.9815-2713T(b)(3); 29 CFR 
2590.715-2713(b)(3); 45 CFR 147.130(b)(3).
    \3\ The references to ``women'' in these proposed rules should 
be considered to include any individual potentially capable of 
becoming pregnant, including cisgender women, transgender men, and 
non-binary individuals. Plans and issuers are required to cover 
contraceptive services for all such individuals consistent with the 
requirements in 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 
CFR 147.130. See FAQs About Affordable Care Act Implementation (Part 
XXVI) (May 11, 2015), Q5, available at 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.
    \4\ The references in this document to ``contraception,'' 
``contraceptive,'' ``contraceptive coverage,'' or ``contraceptive 
services'' generally include all contraceptives, sterilization, and 
related patient education and counseling recommended by the HRSA-
Supported Women's Preventive Services Guidelines, unless otherwise 
indicated. The Guidelines issued in 2011 referred to ``Contraceptive 
Methods and Counseling'' as ``[a]ll Food and Drug Administration 
approved contraceptive methods, sterilization procedures, and 
patient education and counseling for all women with reproductive 
capacity.'' The Guidelines, as amended in December 2016 refer, under 
the header ``Contraception,'' to: ``the full range of female-
controlled U.S. Food and Drug Administration-approved contraceptive 
methods, effective family planning practices, and sterilization 
procedures,'' ``contraceptive counseling, initiation of 
contraceptive use, and follow-up care (e.g., management, and 
evaluation as well as changes to and removal or discontinuation of 
the contraceptive method),'' and ``instruction in fertility 
awareness-based methods, including the lactation amenorrhea 
method.'' See 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/. The following sentence appears in the 
December 2016 Guidelines: ``Additionally, instruction in fertility 
awareness-based methods, including the lactation amenorrhea method, 
although less effective, should be provided for women desiring an 
alternative method.'' Although that specific sentence does not 
appear in the December 2021 Guidelines, HRSA maintains that other 
language in the December 2021 Guidelines establishes that such 
instruction is included in those Guidelines. Additionally, the U.S. 
District Court for the Eastern District of Texas has issued a 
temporary restraining order and preliminary injunction that the 
effective date of the deletion of that sentence from the December 
2021 Guidelines is delayed until further order of the Court, and as 
a consequence the sentence remains in those Guidelines. The Court 
enjoined HRSA and all persons in active concert or participation 
with them from using or applying the December 2021 Guidelines to 
delete the above language, thereby maintaining that current language 
unless and until it is changed through a final rule issued after 
notice to the public and an opportunity to comment. Tice-Harouff v. 
Johnson, 6:22-cv-201-JDK (E.D. Tex. Aug. 12, 2022).
---------------------------------------------------------------------------

    HHS, DOL, and the Department of the Treasury (collectively, the 
Departments) previously issued rules and guidance implementing section 
2713 of the PHS Act, including guidance specific to coverage of 
contraceptive services.\5\ The Departments also previously issued rules 
providing exemptions from the contraceptive coverage requirement for 
entities and individuals with moral or religious objections to 
contraceptive coverage, and accommodations through which objecting 
entities are not required to contract, arrange, pay, or provide a 
referral for contraceptive coverage while at the same time ensuring 
that participants, beneficiaries, and enrollees enrolled in coverage 
sponsored or arranged by an objecting entity could separately obtain 
contraceptive services at no cost. Specifically, the Departments have 
issued:
---------------------------------------------------------------------------

    \5\ 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

[[Page 7238]]

simultaneously ensuring that certain nonprofit organizations with 
religious objections to contraceptive coverage would not be required to 
contract, arrange, pay, or provide a referral for that coverage;
     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,\6\ and 
established the process for participating issuers to seek a user fee 
adjustment under the applicable accommodations;
---------------------------------------------------------------------------

    \6\ That accommodation process, which was the only process by 
which certain employers could avoid the contraceptive coverage 
requirement under the July 2013 final rules, now forms the basis for 
what is instead an optional accommodation process under final rules 
published on November 15, 2018, at 83 FR 57536 (November 2018 
Religious Exemption final rules).
---------------------------------------------------------------------------

     Interim final rules on August 27, 2014, at 79 FR 51092 
(August 2014 interim final rules), which amended the July 2013 final 
rules in light of the United States Supreme Court's interim order in 
connection with an application for an injunction in Wheaton College v. 
Burwell \7\ (Wheaton interim order), and provided an alternative 
process that an eligible organization may use to provide notice of its 
religious objection to the coverage of contraceptive services;
---------------------------------------------------------------------------

    \7\ Wheaton College v. 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 v. Hobby Lobby Stores, Inc.; \8\
---------------------------------------------------------------------------

    \8\ Burwell v. 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 v. Burwell; \9\
---------------------------------------------------------------------------

    \9\ Zubik v. 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) \10\ and that alternative accommodations were not feasible; 
\11\
---------------------------------------------------------------------------

    \10\ 42 U.S.C. 2000bb-1, et seq.
    \11\ 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; \12\
---------------------------------------------------------------------------

    \12\ 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; \13\ and
---------------------------------------------------------------------------

    \13\ FAQs About Affordable Care Act Implementation Part 51, 
Families First Coronavirus Response Act and Coronavirus Aid, Relief, 
and Economic Security Act Implementations (Jan. 10, 2022), available 
at 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.\14\
---------------------------------------------------------------------------

    \14\ 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 v. Hobby 
Lobby Stores, Inc.\15\ The Supreme Court ruled in Hobby Lobby that, 
under RFRA, the contraceptive coverage requirement could not be applied 
to closely held for-profit corporations because doing so imposed a 
substantial burden on the owners' exercise of religion and was not the 
least restrictive means of advancing

[[Page 7239]]

a compelling governmental interest.\16\ In response to Hobby Lobby, the 
July 2015 final rules allowed closely held for-profit companies to 
access the existing accommodation process.
---------------------------------------------------------------------------

    \15\ Burwell v. Hobby Lobby Stores, Inc, 134 S. Ct. 2751 (2014).
    \16\ 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 v. Burwell, 
vacating the judgments of the Courts of Appeals--most of which had 
ruled in the Departments' favor--and remanding the cases ``in light of 
the substantial clarification and refinement in the positions of the 
parties'' that had been supplied in supplemental briefs.\17\ The Court 
anticipated that, on remand, the Courts of Appeals would ``allow the 
parties sufficient time to resolve any outstanding issues between 
them.'' \18\ The Departments issued the July 2016 RFI to gather public 
comments in response to the Zubik decision.
---------------------------------------------------------------------------

    \17\ Zubik v. Burwell, 136 S. Ct. 1557, 1560 (2016).
    \18\ 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.\19\ Some 
comments received in response to the July 2016 RFI suggested that such 
an accommodation process would not be acceptable to some employers with 
religious objections, and some comments suggested that it would create 
significant administrative and operational challenges that would 
potentially undermine individuals' seamless access to full and equal 
health coverage, including contraceptive coverage. Commenters also 
noted that the process would not work for self-insured plans for which 
there is no issuer with a duty to provide coverage. The Zubik 
plaintiffs alternatively suggested creating contraceptive-only 
insurance policies in which women would affirmatively enroll. Comments 
received in response to the July 2016 RFI expressed, among other 
concerns, that these policies might not be authorized under State 
contract and insurance law.
---------------------------------------------------------------------------

    \19\ 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 v. 
Burwell, a nonprofit, non-religious organization and two of the 
organization's individual employees filed a complaint claiming that the 
contraceptive coverage requirement (1) violated the equal protection 
component of the Due Process Clause of the Fifth Amendment, (2) 
violated the individual employees' rights under RFRA, (3) violated the 
individuals' rights under the First Amendment's Free Exercise Clause, 
and (4) was arbitrary and capricious under the Administrative Procedure 
Act (APA).\20\ Challenges by non-religious, nonprofit organizations led 
to conflicting opinions among Federal courts. On August 31, 2015, the 
District Court for the District of Columbia agreed with the March for 
Life plaintiffs on the organization's equal protection claim and the 
employees' RFRA claims, and while not ruling on the APA claim, issued a 
permanent injunction against the Departments.\21\ That injunction 
remains in place. Conversely, in another case, the U.S. Court of 
Appeals for the Third Circuit (Third Circuit) on August 4, 2017 held 
that Real Alternatives--a non-religious section 501(c)(3) nonprofit 
organization and a moral objector--was not similarly situated to a 
religious organization and was therefore not entitled to an 
exemption.\22\ The Third Circuit concluded that ``a secular 
antiabortion group mirrors a single-issue interest group and not a 
religious organization that takes advantage of the Exemption.'' \23\ In 
refusing to extend the exemption to a secular nonprofit organization, 
the Third Circuit recognized the ``vast history of legislative 
protections that single out and safeguard religious freedom but not 
moral philosophy.'' \24\
---------------------------------------------------------------------------

    \20\ March for Life v. Burwell, 128 F. Supp. 3d 116 (D.D.C. 
2015).
    \21\ Id. at 134.
    \22\ Real Alternatives v. Sec'y of HHS, 150 F. Supp. 3d 419, 
affirmed 867 F. 3d 338 (3d Cir. 2017).
    \23\ Id. at 349.
    \24\ Id. at 350.
---------------------------------------------------------------------------

    In October 2017, the Departments issued the October 2017 Moral 
Exemption interim final rules and the October 2017 Religious Exemption 
interim final rules (together, the October 2017 interim final rules), 
each of which went into effect immediately upon release. Those rules 
expanded exemptions and accommodations to include employers that object 
to contraceptive coverage on nonreligious moral grounds, along with 
expanding the available religious exemptions. As stated in the October 
2017 Moral Exemption interim final rules, with respect to the new 
exemption for non-religious nonprofit organizations, the Departments 
were aware of two small nonprofit organizations that had filed lawsuits 
raising non-religious moral objections to coverage of some 
contraceptives. HHS noted in the 2017 Moral Exemption interim final 
rules that both of those entities had fewer than five employees 
enrolled in health coverage, and both required all of their employees 
to agree with their opposition to the coverage as a condition of 
employment.\25\ In the November 2018 Moral Exemption final rules, 
without data available to estimate the actual number of entities that 
would make use of the expanded exemption for for-profit entities 
without publicly traded ownership interests and that object to the 
contraceptive coverage requirement based on sincerely held moral 
convictions, the Departments estimated that fewer than 10 entities, if 
any, would do so.\26\
---------------------------------------------------------------------------

    \25\ 82 FR 47856-47857.
    \26\ 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.\27\ They all 
asked the courts to enjoin the interim final rules.
---------------------------------------------------------------------------

    \27\ Nine other states later joined the California litigation: 
Connecticut, Hawaii, Illinois, Minnesota, North Carolina, Rhode 
Island, Vermont, Washington, and Oregon, along with the District of 
Columbia, and an additional three states (Colorado, Michigan, and 
Nevada) moved to intervene in June 2019.
---------------------------------------------------------------------------

    Two Federal district courts issued preliminary injunctions blocking 
the October 2017 interim final rules nationwide. The Northern District 
of California did so based on the states' likelihood of success on 
their procedural APA claim--that the interim final rules were invalid 
for failing to follow notice and comment rulemaking.\28\ On appeal, the 
Ninth Circuit affirmed the district court decision though it limited 
the geographic scope of the injunction to the five states that were 
then plaintiffs in the case. The Eastern District of Pennsylvania 
enjoined the interim final rules nationwide, holding that plaintiffs 
were likely to succeed on their claims

[[Page 7240]]

that the Departments did not follow proper procedures in issuing the 
interim final rules, and that the interim final rules contradict the 
statute.\29\ While the preliminary injunctions were on appeal, the 
Departments issued the November 2018 Religious Exemption final rules 
and the November 2018 Moral Exemption final rules (together, the 
November 2018 final rules). The district courts in California and 
Pennsylvania both enjoined enforcement of the November 2018 final 
rules, and the courts of appeals upheld those injunctions.\30\
---------------------------------------------------------------------------

    \28\ California v. Azar, 281 F. Supp. 3d 806 (N.D. Cal. 2017), 
affirmed, 911 F.3d 558 (9th Cir. 2018).
    \29\ See Pennsylvania v. Trump, 281 F. Supp. 3d 553 (E.D. Pa. 
2017), affirmed, 930 F.3d 543 (3d Cir. 2019).
    \30\ See Pennsylvania v. Trump, 351 F. Supp. 3d 791 (E.D. Pa. 
2019), affirmed, 930 F.3d 543 (3d Cir. 2019); and California v. 
Azar, 351 F. Supp. 3d 1267 (N.D. Cal. 2019) (enjoining the final 
rules with respect to 14 plaintiff states and the District of 
Columbia); affirmed, 941 F.3d 410 (9th Cir. 2019).
---------------------------------------------------------------------------

    The November 2018 Religious Exemption final rules ultimately 
expanded existing exemptions for individuals and entities with 
religious objections to coverage of contraceptive services. All 
nonprofit and for-profit employers with sincerely held religious 
objections to contraceptive coverage became eligible for religious 
exemptions, as did private universities and colleges with religious 
objections with respect to student health insurance coverage. Those 
rules retained the existing accommodation process but made it 
optional.\31\
---------------------------------------------------------------------------

    \31\ 83 FR 57536, 57537-38.
---------------------------------------------------------------------------

    In January 2020, the Supreme Court granted petitions for writ of 
certiorari in the Trump v. Pennsylvania and Little Sisters of the Poor 
Saints Peter and Paul Home v. Pennsylvania cases and consolidated them, 
to review whether the Departments had the authority to promulgate rules 
exempting employers with religious or moral objections from the 
requirement to cover contraceptive services.\32\ The Court held that 
the Departments have broad authority to identify and create both moral 
and religious exemptions and that the final rules were not procedurally 
invalid.\33\ The Court indicated that it was proper for the Departments 
to take RFRA into account when considering religious exemptions, but 
the Court did not decide whether the rules violated the APA's 
arbitrary-and-capricious standard.\34\ In litigation following the 
Supreme Court's decision, some plaintiffs continue to argue that the 
Departments did not sufficiently weigh the benefits of expanded 
employer exemptions against the harms of depriving more women of 
contraceptive coverage.\35\
---------------------------------------------------------------------------

    \32\ Little Sisters of the Poor Saints Peter & Paul Home v. 
Pennsylvania, 140 S. Ct. 918 (2020).
    \33\ Little Sisters of the Poor Saints Peter & Paul Home v. 
Pennsylvania, 140 S. Ct. 2367, 2386 (2020).
    \34\ Id. at 2383-84.
    \35\ See appellees supplemental brief, State of California v. 
Azar, Nos. 19-15072, 19-15118, 19-15150 (9th Cir., Aug. 28, 2020). 
(``For example, the court will have to determine . . . whether 
defendants' justifications are implausible because the Exemption 
Rules are not tailored to address the purported problems that the 
Rules identify . . .'')
---------------------------------------------------------------------------

    Individuals also filed lawsuits claiming that the contraceptive 
coverage requirement forced them to choose between (1) purchasing 
health insurance that forces them to subsidize abortion or (2) forgoing 
health insurance. The District Court for the Northern District of Texas 
agreed with the plaintiffs in a class action lawsuit, DeOtte v. Azar, 
and issued a permanent injunction covering a class of individuals and a 
class of employers, which was ultimately vacated by the Fifth 
Circuit.\36\
---------------------------------------------------------------------------

    \36\ DeOtte v. Azar, 393 F. Supp. 3d 490 (N.D. Tex. 2019), 
DeOtte v. Nevada, No. 19-10754 (5th Cir. Dec. 17, 2021).
---------------------------------------------------------------------------

    The states continue to challenge the November 2018 final rules as 
arbitrary and capricious in three lawsuits. In Massachusetts v. Dept. 
of Health & Human Services, Massachusetts argued that the moral 
exemption is overbroad, and that the Departments failed to consider the 
reliance interests of women who stand to lose contraceptive coverage 
due to either of the exemptions.\37\ The U.S. District Court for the 
District of Massachusetts ruled that the November 2018 final rules were 
neither arbitrary and capricious nor unconstitutional.\38\ The 
Massachusetts litigation (now on appeal) is currently being held in 
abeyance, while California v. Becerra and Pennsylvania v. Biden are 
stayed.\39\
---------------------------------------------------------------------------

    \37\ See Mem. & Order (Op.), Massachusetts v. Dept. of Health & 
Human Services, No. 17-cv-11930 (D. Mass. Jan. 15, 2021), ECF No. 
139.
    \38\ Id.
    \39\ See Stay Order, Massachusetts v. Dept. of Health & Human 
Services, No. 21-1076 (1st Cir. Mar. 12, 2021); Joint Status Report, 
California v. Becerra, No. 4:17 cv 5783-HSG (N.D. Cal. Oct. 29, 
2021); and Stay Order, Pennsylvania v. Biden, No. 2:17-cv-04540-WB 
(E.D. Pa. March 8, 2021).
---------------------------------------------------------------------------

B. Basis for Rulemaking

    Section 2713(a)(4) of the PHS Act, also known as the Women's Health 
Amendment, was enacted as part of the ACA to ensure that plans and 
health insurance issuers cover women's preventive health needs. Access 
to contraception is an essential component of women's health care in 
part because contraception is effective at reducing unintended 
pregnancy. Studies report that 99 percent of sexually-active women have 
used at least one method of contraception at some point during their 
lifetime,\40\ regardless of religious affiliation.\41\ The Centers for 
Disease Control and Prevention (CDC) found that 65.3 percent of 
American women aged 15 to 49 years were using contraception from 2017 
to 2019.\42\ The contraceptive coverage requirement has resulted in 
more women using contraception, especially long-acting reversible 
contraceptives (LARCs), such as intrauterine devices (IUDs) and 
implants.\43\ Without health insurance or other health coverage, 
contraception can be prohibitively expensive,\44\ and the cost may 
deter women from obtaining needed care.\45\ Unintended pregnancies have 
negative health consequences for both women and children.\46\ Poor and 
low-income women are most likely to have an unintended pregnancy \47\ 
and are also more likely to be unable to afford contraception. Further, 
the U.S. Supreme Court's decision in Dobbs v. Jackson Women's Health 
Organization, \48\ which allows for Federal and State laws that 
significantly limit access to abortion and thus removes one key option 
for women in making health care decisions, has placed a heightened 
importance on access to contraceptive services nationwide. Ensuring 
access to

[[Page 7241]]

contraception at no cost (other than the premium or contribution paid 
for health coverage \49\) is a national public health imperative, as it 
is a means to prevent unintended pregnancies and help provide better 
health and economic outcomes for women, so that they can exercise 
control over their reproductive health and family planning decisions, 
particularly in states with prohibitions or tight restrictions on 
abortion.
---------------------------------------------------------------------------

    \40\ Daniels, K., Mosher, W., & Jones, J. (2013). Contraceptive 
Methods Women Have Ever Used: United States, 1982-2010. National 
Health Statistics Reports, 62: 1-15.
    \41\ Jones, R.K. (2020). People of all Religions Use Birth 
Control and Have Abortions. Guttmacher Institute. https://www.guttmacher.org/print/article/2020/10/people-all-religions-use-birth-control-and-have-abortions.
    \42\ National Center for Health Statistics, Current 
Contraceptive Status Among Women Aged 15-49: United States, 2017-
2019. Daniels, K., & Abma, J.C. (2020) Current contraceptive status 
among women aged 15-49: United States, 2017-2019. NCHS Data Brief, 
no 388. Hyattsville, MD: National Center for Health Statistics. 
Available at https://www.cdc.gov/nchs/products/databriefs/db388.htm.
    \43\ Snyder, A. H., Weisman, C. S., Liu, G., Leslie, D., & 
Chuang, C. H. (2018). The Impact of the Affordable Care Act on 
Contraceptive Use and Costs among Privately Insured Women. Women's 
health issues: official publication of the Jacobs Institute of 
Women's Health, 28(3), 219-223. https://doi.org/10.1016/j.whi.2018.01.005.
    \44\ Becker, N.V. & Polsky, D. (2015). Women Saw Large Decrease 
in Out-Of-Pocket Spending for Contraceptives After ACA Mandate 
Removed Cost Sharing. Health Affairs, 34(7): 1204-1208. Available at 
https://www.healthaffairs.org/doi/10.1377/hlthaff.2015.0127.
    \45\ Sonfield, A. (2011). ``The Case for Insurance Coverage of 
Contraceptive Services and Supplies Without Cost-Sharing.'' 
Guttmacher Policy Review, 14(1): 7-15.
    \46\ ``Preventing Unplanned Pregnancy.'' National Conference of 
State Legislatures (2021). Available at: https://www.ncsl.org/research/health/preventing-unplanned-pregnancy.aspx.
    \47\ Guttmacher Institute (2019). ``Unintended Pregnancy in the 
United States.'' Available at https://www.guttmacher.org/sites/default/files/factsheet/fb-unintended-pregnancy-us.pdf.
    \48\ Dobbs v. Jackson Women's Health Organization, No. 19-1392, 
597 U.S. __(2022).
    \49\ For ease of reference, this preamble describes the proposed 
individual contraceptive arrangement as providing access to 
contraceptive services ``at no cost.'' However, individuals eligible 
for the individual contraceptive arrangement would typically have to 
pay a premium or contribution to enroll in the group health plan or 
health insurance coverage sponsored, arranged, or provided by an 
objecting entity.
---------------------------------------------------------------------------

    In previous rulemakings, the Departments established exemptions and 
accommodations for a variety of entities. Although the November 2018 
final rules expanded religious exemptions, the Departments have 
concluded that these rulemakings did not give sufficient consideration 
to women's significant interests in access to contraceptive services. 
Requiring individuals with low incomes to pay out-of-pocket for 
contraceptive services creates a disproportionate financial burden and 
unnecessary barrier to care for those individuals who must spend a 
greater percentage of their income on contraceptive services.\50\ The 
exemptions also ignore the government interest in promoting coverage 
for contraceptive services and assuring access to contraception. 
Furthermore, section 1 of Executive Order 13985, ``Executive Order on 
Advancing Racial Equity and Support for Underserved Communities Through 
the Federal Government'' (E.O. 13985), instructs the Federal Government 
to consider ways to affirmatively advance equity, civil rights, racial 
justice, and equal opportunity, with an emphasis on including 
historically marginalized communities and individuals. As noted 
previously, requiring individuals to pay out-of-pocket for 
contraceptive services will disproportionately burden low-wage workers. 
A considerable percentage of low-income women in the U.S. already rely 
on safety-net clinics for contraception services.\51\ Low-income women 
also have the least access to contraception through employer-sponsored 
health insurance.\52\ Given that non-white women are overrepresented 
among low-wage workers, exemptions for employers of low-wage workers 
from requiring coverage for contraceptive services could further 
disproportionately burden non-white women by limiting their access to 
contraceptive coverage and reproductive care through employer-sponsored 
coverage. This decrease in access to health care has also resulted in 
an increase in the prevalence of unplanned pregnancies for non-white 
and low-income individuals.\53\ In addition, historically marginalized 
communities and individuals are disproportionately affected by racial 
biases in health care. Racial bias has led to more skepticism about the 
safety of women's health care and less knowledge about the efficacy of 
various forms of birth control for family planning among non-white 
women.\54\
---------------------------------------------------------------------------

    \50\ Although many women try and use multiple contraceptive 
methods for various reasons, nearly one in five women (18 percent) 
say they are not currently using their preferred method of birth 
control. The primary reason women say they are not using their 
preferred method of contraception is because they cannot afford it. 
See Frederiksen, B., Ranji, U., Salganikoff, A., & Long, M., (2021), 
Women's Sexual and Reproductive Health Services: Key Findings from 
the 2020 KFF Women's Health Survey. https://www.kff.org/womens-health-policy/issue-brief/womens-sexual-and-reproductive-health-services-key-findings-from-the-2020-kff-womens-health-survey/.
    \51\ Ranji, U., Salganicoff, A., Sobel, L., & Gomez, I. (2017). 
Financing family planning services for low-income women: The role of 
public programs. The Henry J. Kaiser Family Foundation. https://www.kff.org/wp-content/uploads/2019/10/Issue-Brief-Financing-Family-Planning-Services-for-Low-income-Women-1.pdf
    \52\ 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/.
    \53\ Finer, L. & Zolna, M. (2016). ``Declines in Unintended 
Pregnancy in the United States, 2008-2011.'' N Engl J Med, 
374(9):843-52 and Behn, M., Pace, LE. et al.(2019). ``The Trump 
Administration's Final Regulations Limit Insurance Coverage of 
Contraception.'' Women's Health Issues, 29(2): 103-106.
    \54\ Payne, C., & Fanarjian, N. (2014). Seeking causes for race-
related disparities in contraceptive use. Virtual Mentor, 16(10), 
805-809. 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.\55\ Improving access to contraceptive services is critical 
to narrowing disparities in reproductive health access and outcomes, as 
well as longer-term outcomes. Access to postpartum contraception is 
important to increase spacing between pregnancies, as short intervals 
between pregnancies can be associated with adverse health outcomes.\56\ 
Access to contraceptive services without cost sharing increases 
knowledge about safe and effective forms of birth control planning and 
decreases financial constraints that prevent continuation of 
appropriate contraception use for women in marginalized communities. 
Additionally, access to contraceptive services has wide-ranging 
economic effects for women, from increased educational attainment to 
increases in labor force participation and lifetime earnings.\57\
---------------------------------------------------------------------------

    \55\ Sutton, M. Y., Anachebe, N. F. & Skanes H. (2021). ``Racial 
and Ethnic Disparities in Reproductive Health Services and Outcomes, 
2020.'' Obstetrics and gynecology, 137(2), 225-233. https://doi.org/10.1097/AOG.0000000000004224.
    \56\ 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.
    \57\ See Bernstein, Anna and Kelly M. Jones (2019). ``The 
Economic Effects of Contraceptive Access: A Review of the 
Evidence.'' Institute for Women's Policy Research. Available at 
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).\58\ Section 3 of E.O. 14009 directs HHS, and the 
heads of all other executive departments and agencies with authorities 
and responsibilities related to Medicaid and the ACA, to review all 
existing regulations, orders, guidance documents, policies, and any 
other similar agency actions to determine whether they are inconsistent 
with policy priorities described in section 1 of E.O. 14009, to include 
protecting and strengthening the ACA and making high-quality health 
care accessible and affordable for all individuals.\59\ The ACA is 
fundamentally ``designed to broaden access to healthcare and insurance 
coverage.'' \60\ Further, the Women's Health Amendment was designed to 
expand access to the preventive care and screenings that

[[Page 7242]]

women require.\61\ HHS issued the HRSA-Supported Guidelines pursuant to 
the Women's Health Amendment that included contraceptives as a category 
of preventive services recommended for women. If finalized, these 
proposed rules would better align the preventive services regulations 
with the policy priorities described in section 1 of E.O. 14009 by 
expanding access to contraceptive services without cost sharing to 
individuals whose health plans currently do not or would not offer such 
coverage due to a religious or moral objection.
---------------------------------------------------------------------------

    \58\ 86 FR 7793 (February 2, 2021).
    \59\ E.O. 14009 also revoked Executive Order 13765 of January 
20, 2017 (Minimizing the Economic Burden of the Patient Protection 
and Affordable Care Act Pending Repeal). The Departments adopted the 
moral exemption and accommodation in part to further this now 
revoked Executive Order by relieving a regulatory burden imposed on 
entities with moral convictions opposed to providing certain 
contraceptive coverage.
    \60\ Religious Sisters of Mercy v. Azar, 513 F. Supp. 3d 1113 
(D.N.D. 2021).
    \61\ To implement the Women's Health Amendment, HRSA 
commissioned the independent Institute of Medicine, now known as the 
National Academy of Medicine, to conduct a scientific review and 
provide recommendations on specific preventive measures that meet 
women's health needs.
---------------------------------------------------------------------------

    Also, on January 28, 2021, President Biden issued a Memorandum on 
``Protecting Women's Health at Home and Abroad.'' \62\ Section 1 of the 
Memorandum stated ``[w]omen should have access to the healthcare they 
need. For too many women today, both at home and abroad, that is not 
possible . . . The Federal Government must take action to ensure that 
women at home and around the world are able to access complete medical 
information, including with respect to their reproductive health.'' 
These proposed rules would, if finalized, help to support women's 
access to reproductive health care services at home.
---------------------------------------------------------------------------

    \62\ 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).\63\ Section 2 of E.O. 14070 requires 
the heads of appropriate agencies to, in addition to taking the actions 
directed pursuant to E.O. 14009, take several other actions, including 
examine policies or practices that make it easier for all consumers to 
enroll in and retain coverage, understand their coverage options, and 
select appropriate coverage; that strengthen benefits and improve 
access to health care providers; that improve the comprehensiveness of 
coverage and protect consumers from low-quality coverage; that expand 
eligibility and lower costs for coverage in the ACA Exchanges, 
Medicaid, Medicare, and other programs; that help improve linkages 
between the health care system and other stakeholders to address 
health-related needs; and that help reduce the burden of medical debt 
on households. These proposed rules would further the goals of E.O. 
14070.
---------------------------------------------------------------------------

    \63\ 87 FR 20689.
---------------------------------------------------------------------------

    On July 8, 2022, President Biden issued Executive Order 14076, 
``Protecting Access to Reproductive Healthcare Services (E.O. 14076).'' 
\64\ Section 3 of E.O. 14076 requires the Secretary of HHS to submit a 
report to the President identifying potential actions to ``protect and 
expand access to the full range of reproductive healthcare services, 
including actions to enhance family planning services such as access to 
emergency contraception'' and ``identifying ways to increase outreach 
and education about access to reproductive healthcare services, 
including by launching a public awareness initiative to provide timely 
and accurate information about such access, which shall include 
promoting awareness of and access to the full range of contraceptive 
services.'' These proposed rules would take critical steps to further 
the goals in E.O. 14076 by expanding access to the full range of 
contraceptive services for women enrolled in coverage established or 
maintained by an objecting entity, or in health insurance coverage 
offered or arranged by an objecting entity.
---------------------------------------------------------------------------

    \64\ 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.\65\ 
Given that the November 2018 final rules allow, but do not require, 
objecting entities to invoke the accommodation process, many women in 
plans subject to an exemption may be unable to access contraceptive 
services due to financial, logistical, or administrative barriers.
---------------------------------------------------------------------------

    \65\ In the November 2018 final rules, the Departments estimated 
that between 70,500 and 126,400 women may have lost contraceptive 
coverage as a result of the November 2018 Religious Exemption final 
rules, and that approximately 15 women may have incurred 
contraceptive costs due to use of the November 2018 Moral Exemption 
final rules by for-profit entities.
---------------------------------------------------------------------------

    These proposed rules seek to ensure that women who are enrolled in 
either a group health plan established or maintained by an objecting 
entity, or in health insurance coverage offered or arranged by an 
objecting entity, including an employer, institution of higher 
education, or health insurance issuer, have access to cost-free 
contraceptive coverage, even when the objecting entity claims the 
regulatory exemption without voluntarily using the accommodation 
process. This proposed approach would further the government's interest 
in protecting women's health and their right to make reproductive 
decisions.
    In light of these considerations, the Departments are issuing these 
proposed rules to further the government's interest in promoting 
coverage for contraceptive services for all women,\66\ and in 
eliminating barriers to access, while respecting the religious 
objections of employers, health insurance issuers, and institutions of 
higher education to coverage of contraceptive services.
---------------------------------------------------------------------------

    \66\ 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

[[Page 7243]]

provided or administered the health coverage furnished by the eligible 
organization, and without financial, logistical, or administrative 
obstacles.
    As explained in section I.A of this preamble, several employers 
challenged the contraceptive coverage accommodation under RFRA. These 
religious-objector employers alleged that the accommodation violated 
RFRA by making them complicit in the provision of contraceptive 
services and care. These employers also asserted that the public 
interest of ensuring women have access to contraceptive coverage can be 
accomplished in a way that complies with RFRA, that is, in a less 
restrictive way than the accommodation. Ultimately, the Departments 
issued the November 2018 final rules, which significantly expanded the 
types of entities eligible for a religious exemption, created an 
exemption for entities with a non-religious moral objection, and made 
the aforementioned accommodation optional.
    As noted previously, a number of states challenged the November 
2018 final rules in court, arguing that these rules are unlawfully 
arbitrary and capricious. In light of this litigation, and upon further 
consideration, the Departments have determined that the November 2018 
final rules failed to adequately account for women's legal entitlement 
to access preventive care, critically including contraceptive services, 
without cost sharing as Congress intended; the impact on the number of 
unintended pregnancies; the costs to states and individuals of such 
pregnancies; and the government's interest in ensuring women have 
access to this coverage.
    These proposed rules, if finalized, seek to resolve the long-
running litigation with respect to religious objections to providing 
contraceptive coverage, by respecting the objecting entities' religious 
objections while also ensuring that women enrolled in plans or coverage 
sponsored, arranged, or provided by objecting entities have the 
opportunity to obtain contraceptive services at no cost. These rules 
propose to maintain the November 2018 final rules' religious exemption 
for entities with sincerely held religious objections to providing 
coverage for contraceptive services, under the preventive services 
guidelines pursuant to 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-
2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv). Additionally, under these 
proposed rules, entities that sponsor insured or self-insured group 
health plans or arrange student health insurance coverage and that are 
exempt based on their religious objections would continue to be able to 
choose to invoke the optional accommodation set forth in the November 
2018 Religious Exemption final rules at 26 CFR 54.9815-2713A, 29 CFR 
2590.715-2713A, and 45 CFR 147.131 (as applicable). These proposed 
rules would confirm that this optional accommodation for exempt 
religious-objector entities is available to entities that are 
institutions of higher education.
    While these proposed rules would maintain the religious exemption 
rule, they also would provide an independent pathway through which 
women enrolled in plans or coverage sponsored, arranged, or provided by 
objecting entities can access contraceptive services at no cost. With 
respect to participants and beneficiaries in insured or self-insured 
group health plans sponsored by an exempt entity, or enrollees in 
individual health insurance coverage (including student health 
insurance coverage) arranged or provided by an exempt entity, and that 
does not invoke the optional accommodation (if eligible), these 
proposed rules would create a pathway, independent from the employer, 
group health plan, plan sponsor, or issuer, through which individuals 
could obtain at no cost from a willing provider of contraceptive 
services \67\ (that meets certain requirements), contraceptive services 
for which their plan or issuer would otherwise be required to provide 
coverage absent the religious exemption. These proposed rules refer to 
this pathway as the individual contraceptive arrangement. This 
individual contraceptive arrangement would be available to the 
participant, beneficiary, or enrollee without the plan sponsor or 
issuer having to take any action that would facilitate the coverage to 
which it objects. Simply put, the action is undertaken by the 
individual, for the individual. Through the individual contraceptive 
arrangement, a provider of contraceptive services, who provides these 
services at no cost to the women receiving them, would be able to seek 
reimbursement from an issuer with whom it has a signed agreement for 
the cost of providing contraceptive services to women covered under 
these plans. These proposed rules also would amend 45 CFR 156.50(d) so 
that a qualified health plan (QHP) issuer that has agreed to reimburse 
an eligible provider of contraceptive services that participates in the 
individual contraceptive arrangement would be eligible for an 
adjustment to the issuer's Federally-facilitated Exchange (FFE) or 
State Exchange on the Federal platform (SBE-FP) fee through the same 
mechanism for the user fee adjustment previously established in 45 CFR 
156.50(d).
---------------------------------------------------------------------------

    \67\ These proposed rules refer to providers, consistent with 
the proposed definition of the term ``provider of contraceptive 
services,'' as including both health care providers and facilities. 
This definition is discussed later in this preamble.
---------------------------------------------------------------------------

    Finally, as discussed in section II.C.2 of this preamble, this 
proposed rule would eliminate the exemption and the availability of the 
optional accommodation for entities that object to contraceptive 
coverage based on non-religious moral beliefs. As more fully explained 
in that section, there have not been a large number of entities that 
have expressed a desire for an exemption based on a non-religious moral 
objection, the Departments are under no legal obligation to provide 
such an exemption, and RFRA would never apply to require such an 
exemption. Additionally, in light of the Supreme Court's decision in 
Dobbs, the Departments have concluded that it is all the more critical 
now to ensure women's access to reproductive health care and 
contraceptive services without cost sharing, and have determined that 
it is necessary to provide women enrolled in plans with respect to 
which the sponsor or issuer has non-religious moral objections to 
contraceptive coverage, with such coverage directly through their plan.
    The Departments are of the view that these proposed rules would 
respect the religious objections to contraceptive coverage of 
employers, institutions of higher education, and health insurance 
issuers, by allowing them to continue to rely upon the religious 
exemptions, while also advancing the public interest of ensuring that 
women enrolled in such plans and coverage have access to contraceptives 
with no cost.

B. Coverage of Preventive Health Services (26 CFR 54.9815-2713, 29 CFR 
2590.715-2713, and 45 CFR 147.130)

1. Background on Requirement To Cover Contraceptive Services
    Pursuant to 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-
2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), a group health plan, or a 
health insurance issuer offering group or individual health insurance 
coverage, generally must provide coverage and must not impose any cost-
sharing requirements (such as a copayment, coinsurance, or a 
deductible) for, with respect to women, such additional preventive care 
and screenings not described in 26 CFR 54.9815-2713(a)(1)(i), 29 CFR 
2590.715-2713(a)(1)(i), and 45 CFR 147.130(a)(1)(i), as provided for in

[[Page 7244]]

comprehensive guidelines supported by HRSA for purposes of section 
2713(a)(4) of the PHS Act. The currently applicable \68\ HRSA-Supported 
Guidelines, as updated on December 17, 2019, include a guideline that 
adolescent and adult women have access to the full range of female-
controlled FDA-approved contraceptive methods,\69\ effective family 
planning practices, and sterilization procedures to prevent unintended 
pregnancy and improve birth outcomes.\70\ The currently applicable 
HRSA-Supported Guidelines state that contraceptive care should include 
contraceptive counseling, initiation of contraceptive use, and follow-
up care (for example, management and evaluation as well as changes to, 
and removal or discontinuation of, the contraceptive method), and that 
instruction in fertility awareness-based methods, including the 
lactation amenorrhea method, should be provided for women desiring an 
alternative method.
---------------------------------------------------------------------------

    \68\ As explained in FN 4, in December 2021, HRSA approved 
updates to the contraception guidelines that apply to plan years (in 
the individual market, policy years) starting on and after December 
30, 2022. See changes at https://www.hrsa.gov/womens-guidelines.
    \69\ The Departments note that the FDA approves, clears, and 
grants contraceptive products and not methods.
    \70\ 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 
\71\ including, but not limited to, barrier methods, hormonal methods, 
and implanted devices, as well as patient education and counseling, as 
prescribed by a health care provider.\72\ The FAQs further clarified 
that plans and issuers may use reasonable medical management techniques 
to control costs and promote efficient delivery of care, such as 
covering a generic drug without cost sharing and imposing cost sharing 
for equivalent branded drugs. However, FAQs Part XII stated that, in 
these instances, a plan or issuer must accommodate any individual for 
whom a particular drug (generic or brand name) would be medically 
inappropriate, as determined by the individual's health care provider, 
by having a mechanism for waiving the otherwise applicable cost sharing 
for the brand or non-preferred brand version. The FAQs also clarified 
that contraceptive products that are generally available over-the-
counter are required to be covered only if they are both FDA-approved, 
cleared, or granted and prescribed by a health care provider.\73\
---------------------------------------------------------------------------

    \71\ The FDA does not and never has approved, granted, or 
cleared contraceptive methods, only contraceptive products. See FN 
4, supra.
    \72\ See Q14, available at 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.
    \73\ 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.\74\ The FAQs further clarified that, to the extent 
plans and issuers use reasonable medical management techniques within a 
specified category of contraception, plans and issuers must have an 
easily accessible, transparent, and sufficiently expedient exceptions 
process that is not unduly burdensome on the individual or provider (or 
other individual acting as a patient's authorized representative) to 
ensure coverage without cost sharing of any service or FDA-approved 
item within the specified category of contraception. FAQs Part XXVI 
stated that if an individual's attending provider recommends a 
particular service or FDA-approved item based on a determination of 
medical necessity with respect to that individual, the plan or issuer 
must cover that service or item without cost sharing. The FAQs made 
clear that a plan or issuer must defer to the determination of the 
attending provider. FAQs Part XXVI stated that medical necessity may 
include considerations such as severity of side effects, differences in 
permanence and reversibility of contraceptives, and ability to adhere 
to the appropriate use of the item or service, as determined by the 
attending provider. The FAQs also clarified that the exceptions process 
must provide for making a determination of the claim according to a 
timeframe and in a manner that takes into account the nature of the 
claim (for example, pre-service or post-service) and the medical 
exigencies involved for a claim involving urgent care. FAQs Part XXVI 
additionally clarified that a plan or issuer cannot limit sex-specific 
recommended preventive services based on an individual's sex assigned 
at birth, gender identity, or recorded gender.\75\
---------------------------------------------------------------------------

    \74\ See Q2 and Q3, available at https://www.dol.gov/sites/
dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/
aca-part-xxvi.pdf and 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 Preamble to Final Rules regarding coverage of 
certain preventive services at 78 FR 39870 (July 2, 2013).
    \75\ Id. at Q5.
---------------------------------------------------------------------------

    On April 20, 2016, the Departments issued FAQs about Affordable 
Care Act Implementation Part 31, Mental Health Parity Act 
Implementation, and Women's Health and Cancer Rights Act Implementation 
(FAQs Part 31) stating that if a plan or issuer utilizes reasonable 
medical management techniques within a specified method of 
contraception, the plan or issuer may develop and utilize a standard 
exception form and instructions as part of its steps to ensure that it 
provides an easily accessible, transparent, and sufficiently expedient 
exceptions process that is not unduly burdensome on the individual or a 
provider (or other individual acting as a patient's authorized 
representative).\76\ The FAQs suggested that the Medicare Part D 
Coverage Determination Request Form may serve as a model for plans and

[[Page 7245]]

issuers when developing a standard exception form.\77\
---------------------------------------------------------------------------

    \76\ See Q2, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-31.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-31_Final-4-20-16.pdf.
    \77\ A copy of the Medicare Part D Coverage Determination 
Request Form is available at https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/CoverageDeterminations-.
---------------------------------------------------------------------------

    On January 10, 2022, the Departments issued FAQs about Affordable 
Care Act Implementation Part 51, Families First Coronavirus Response 
Act and Coronavirus Aid, Relief, and Economic Security Act 
Implementation (FAQs Part 51) that reiterated previously issued 
guidance related to coverage of contraceptive services and provided 
examples of practices reported to the Departments that denied 
contraceptive coverage to participants, beneficiaries, and 
enrollees.\78\ The FAQ also clarified that if an individual's attending 
provider determines that a particular service or FDA-approved, cleared, 
or granted contraceptive product is medically appropriate for such 
individual, a plan or issuer must cover that service or product without 
cost sharing, whether or not the service or product is in a category of 
contraception specifically identified in the current HRSA-Supported 
Guidelines.
---------------------------------------------------------------------------

    \78\ See Q9, 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.
---------------------------------------------------------------------------

    On July 28, 2022, the Departments issued FAQs about Affordable Care 
Act Implementation Part 54 (FAQs Part 54) on additional aspects of 
contraceptive coverage, reiterating and clarifying the types of items 
and services required to be covered under PHS Act section 2713 and its 
implementing regulations. Specifically, these FAQs explained that plans 
and issuers are required to cover, without any cost sharing, items and 
services that are integral to the furnishing of a recommended 
preventive service, such as anesthesia necessary for a tubal ligation 
procedure or pregnancy tests needed before provision of certain forms 
of contraceptives, such as an intrauterine device (also known as an 
IUD), regardless of whether the item or service is billed 
separately.\79\ FAQs Part 54 also addressed contraceptive products and 
services that are not included in a category of contraception described 
in the HRSA-Supported Guidelines, reiterating that plans and issuers 
must cover any contraceptive services and FDA-approved, cleared, or 
granted contraceptive products that an individual and their attending 
provider have determined to be medically appropriate for the 
individual, whether or not those services or products are specifically 
identified in the categories listed in the HRSA-Supported 
Guidelines.\80\ Additionally, the FAQs reiterated the requirement to 
cover FDA-approved emergency contraception, including emergency 
contraception that is available over-the-counter (OTC), when 
prescribed, and encouraged plans and issuers to cover OTC emergency 
contraceptive products with no cost sharing when purchased without a 
prescription. The FAQs also state that a health savings account, health 
flexible spending arrangement, or health reimbursement arrangement can 
reimburse expenses incurred for OTC contraception obtained without a 
prescription.\81\ Further, the FAQs addressed instruction in fertility 
awareness-based methods and encouraged plans and issuers to cover the 
dispensing of a 12-month supply of contraception without cost 
sharing.\82\
---------------------------------------------------------------------------

    \79\ See Q1, available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-54.pdf and at https://www.cms.gov/files/document/faqs-part-54.pdf.
    \80\ Id. at Q2.
    \81\ Id. at Q5 and Q6.
    \82\ Id. at Q4 and Q7.
---------------------------------------------------------------------------

    FAQs Part 54 also addressed the use of reasonable medical 
management techniques as applied to contraceptive products or services, 
including explaining that plans and issuers may use reasonable medical 
management techniques for contraceptive products or services not 
included in the categories described in the HRSA-Supported Guidelines 
only if multiple, substantially similar services or products that are 
not included in a category are available and are medically appropriate 
for an individual.\83\ For contraceptive products or services included 
in the categories described in the HRSA-Supported Guidelines, the FAQs 
reiterate that plans and issuers may utilize reasonable medical 
management techniques only within a specified category of contraception 
and only to the extent the HRSA-Supported Guidelines do not specify the 
frequency, method, treatment, or setting for the provision of a 
recommended preventive service that is a contraceptive service or FDA-
approved, cleared, or granted product.\84\ The FAQs offered guidance on 
how to determine whether a medical management technique is reasonable 
for purposes of the requirements under PHS Act section 2713, including 
examples of unreasonable medical management techniques, such as 
imposing an age limit on contraceptive coverage instead of providing 
these benefits to all individuals with reproductive capacity.\85\ In 
addition, FAQs Part 54 offered guidance on what constitutes an easily 
accessible, transparent, and sufficiently expedient exceptions process 
that is not unduly burdensome on the individual or their provider and 
explained that the Departments will consider an exceptions process to 
be easily accessible if plan documentation includes relevant 
information regarding the exceptions process under the plan or 
coverage, including how to access the exceptions process without 
initiating an appeal pursuant to the plan's or issuer's internal claims 
and appeals procedures, the types of information the plan or issuer 
requires as part of a request for an exception, and contact information 
for a representative of the plan or issuer who can answer questions 
related to the exceptions process.\86\ The FAQs state that a plan or 
issuer may not require a participant, beneficiary, or enrollee to 
appeal an adverse benefit determination using the plan or issuer's 
internal claims and appeals process as the means for an individual to 
obtain an exception.\87\
---------------------------------------------------------------------------

    \83\ Id. at Q3.
    \84\ Id. at Q8.
    \85\ Id.
    \86\ Id. at Q9.
    \87\ Id. at Q10.
---------------------------------------------------------------------------

    As explained in FAQs Part 51 and FAQs Part 54, the Departments have 
received a number of complaints and reports regarding potential 
violations of the contraceptive coverage requirement. The Departments 
are committed to ensuring consumers have access to the contraceptive 
benefits, without cost sharing, that they are entitled to under the ACA 
and implementing regulations. In addition to previously issued 
clarifications, the Departments are continuing to assess what changes 
to existing regulations or guidance may be needed to better ensure 
individuals receive the coverage to which they are entitled under the 
law and will issue additional guidance, as warranted. The Departments 
solicit comments regarding whether any other clarifications or 
additional guidance is needed in these proposed rules to help ensure 
that women covered under group health plans or health insurance 
coverage have access to contraceptive services at no cost. Moreover, 
stakeholders who have information regarding potential noncompliance 
with these requirements should contact the Departments as the 
Departments continue to consider what additional oversight and 
enforcement actions could be taken to ensure health plans and issuers 
are complying with the contraceptive benefits guaranteed under the 
ACA.\88\
---------------------------------------------------------------------------

    \88\ As stated in FAQs Part 54, Q14, consumers who have fully-
insured coverage and who have concerns about their health insurance 
issuer's compliance with these requirements may contact their State 
Department of Insurance (for more information, visit https://content.naic.org/state_web_map.htm). Consumers who are covered by a 
private-sector, employer-sponsored group health plan and have 
concerns about their plan's compliance with these requirements may 
contact the Department of Labor at https://www.dol.gov/agencies/ebsa/about-ebsa/ask-a-question/ask-ebsa or by calling toll free at 
1-866-444-3272. Consumers who are covered by a non-Federal public-
sector employer-sponsored plan (such as a State or local government 
employee plan) and have concerns about their plan's compliance with 
these requirements may contact the Center for Consumer Information 
and Insurance Oversight at (888) 393-2789 or 
[email protected] for further assistance with a 
question or issue.

---------------------------------------------------------------------------

[[Page 7246]]

    However, these proposed rules would not alter these coverage 
standards applicable to contraceptive services. Rather, these proposed 
rules focus on the religious and moral objections of entities otherwise 
subject to those coverage standards, and participants', beneficiaries', 
and enrollees' access to contraceptive services without cost sharing 
when their plan or coverage excludes coverage for these services based 
on religious objections and does not adopt the existing optional 
accommodation. No new Federal processes, resources, data systems, or 
reporting mechanisms are anticipated for monitoring and tracking 
entities' objections, or the identities of entities availing themselves 
of these exemptions. Therefore, the Departments propose only minor 
changes to 26 CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 
147.130.
2. Addition of the Phrase ``Evidence-Informed''
    The Departments propose to add the phrase ``evidence-informed'' 
immediately before ``comprehensive'' in 26 CFR 54.9815-2713(a)(1)(iv), 
29 CFR 2590.715-2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), so that 
the reference in the paragraph would be to evidence-informed 
comprehensive guidelines supported by HRSA.
    Section 2713(a) of the PHS Act specifies that the preventive 
services that must be covered without cost sharing are: (1) evidence-
based items or services that have in effect a rating of ``A'' or ``B'' 
in the current recommendations of the United States Preventive Services 
Task Force (USPSTF) with respect to the individual involved; (2) 
immunizations that have in effect a recommendation from the Advisory 
Committee on Immunization Practices of the CDC with respect to the 
individual involved; (3) with respect to infants, children, and 
adolescents, evidence-informed preventive care and screenings provided 
for in the comprehensive guidelines supported by HRSA; and (4) with 
respect to women, such additional preventive care and screenings not 
described in the aforementioned recommendations by USPSTF as provided 
for in comprehensive guidelines supported by HRSA for purposes of 
section 2713(a)(4) of the PHS Act.\89\ The reference to ``evidence-
informed'' preventive care and screenings in comprehensive HRSA-
Supported Guidelines was removed in the October 2017 Religious 
Exemption interim final rules to align with the statutory text.\90\ 
However, because the statute requires that the USPSTF recommendations 
relate to ``evidence-based'' items and services, and because the 
statute also requires that HRSA's guidelines for infants, children, and 
adolescents be ``evidence-informed,'' the Departments are of the view 
that it is consistent with the general purpose of section 2713 of the 
PHS Act that, with respect to women, the additional preventive care and 
screenings provided for in comprehensive guidelines supported by HRSA 
be evidence-informed.\91\
---------------------------------------------------------------------------

    \89\ In addition, under section 3203 of the Coronavirus Aid, 
Relief, and Economic Security (CARES) Act and its implementing 
regulations, plans and issuers must cover, without cost-sharing 
requirements, any qualifying coronavirus preventive service pursuant 
to section 2713(a) of the PHS Act and its implementing regulations 
(or any successor regulations). The term ``qualifying coronavirus 
preventive service'' means an item, service, or immunization that is 
intended to prevent or mitigate coronavirus disease 2019 (COVID-19) 
and that is, with respect to the individual involved (1) an 
evidence-based item or service that has in effect a rating of ``A'' 
or ``B'' in the current USPSTF recommendations; or (2) an 
immunization that has in effect a recommendation from ACIP 
(regardless of whether the immunization is recommended for routine 
use). On November 6, 2020, the Departments published interim final 
rules with a request for comment regarding this requirement, 
Additional Policy and Regulatory Revisions in Response to the COVID-
19 Public Health Emergency (85 FR 71142).
    \90\ The explanation for why the reference to ``evidence-
informed'' was removed, that is, to align with the statutory text, 
was provided in the November 2018 Religious Exemption final rules. 
See 83 FR 57536, 57557 (November 15, 2018).
    \91\ The Departments interpret ``evidence-based'' to require 
that the standards be based solely on scientific ``evidence,'' 
while, as discussed later in this preamble, ``evidence-informed'' 
means that they are informed by a consideration of scientific 
evidence, but such evidence need not be the only basis for its 
standards. As the Court held in Little Sisters, HRSA is also 
authorized to consider the propriety of including exemptions based 
upon religious or moral objections. 140 S. Ct. at 2381.
---------------------------------------------------------------------------

    Furthermore, the Departments recognize that section 2713 of the PHS 
Act establishes special coverage requirements for certain services that 
have been shown by evidence to have benefits as preventive 
services.\92\ Most studies suggest that removing cost-sharing barriers 
to these items and services helps to increase access and utilization by 
participants, beneficiaries, and enrollees who might otherwise delay or 
skip care due to financial barriers.\93\ However, coverage, without 
cost sharing, of recommended preventive items and services and the 
resulting increases in utilization can increase costs to consumers in 
the form of increased premiums, unless those costs are offset by 
savings. By reinstating the requirement that the HRSA-Supported 
Guidelines be evidence-informed, these proposed rules would help ensure 
that plans and issuers are required to cover recommended preventive 
items and services, without cost sharing, only when evidence supports 
the items' or services' value as preventive care. Thus, this proposed 
amendment would help to limit overutilization of services and promote 
efficiencies in care delivery while ensuring that participants, 
beneficiaries, and enrollees have access to critical women's preventive 
services.
---------------------------------------------------------------------------

    \92\ See section 2713(a)(1) and (3) of the PHS Act.
    \93\ Norris, HCH. C., Richardson, HM., et al. (2021). ``H. M., 
Benoit, M. C., Shrosbree, B., Smith, J. E., & Fendrick, A. M. 
(2022). Utilization Impact of Cost-Sharing Elimination for 
Preventive Care Services: A Rapid Review.'' Medical Care Research 
and Review. Available at, 79(2), 175-197. https://journals.sagepub.com/doi/pdf.org/10.1177/10775587211027372.
---------------------------------------------------------------------------

    Additionally, this proposed change would better reflect current 
practice. HRSA's process for developing clinical guidelines for women's 
preventive services is, and has historically been, evidence-based. In 
establishing the HRSA-Supported Guidelines, HHS, acting through HRSA, 
depends on the work of the Women's Preventive Services Initiative 
(WPSI). According to WPSI, its recommendations are intended to guide 
clinical practice and coverage of services for HRSA and other 
stakeholders.\94\ The recommendation development process of the WPSI is 
based on adaptation of the eight criteria for evidence-based clinical 
practice guideline development as articulated in the 2011 report, 
Clinical Practice Guidelines We Can Trust from the National Academy of 
Medicine (formerly the Institute of Medicine [IOM]).\95\ The WPSI 
clinical recommendations are based on reaching a threshold of 
supportive evidence, similar to the 2011 IOM Panel.\96\ The WPSI bases 
recommendations on evidence of both benefits and harms of an 
intervention or service and an assessment of the balance between

[[Page 7247]]

them.\97\ As part of the WPSI process, an evidence report on an 
approved topic is presented to its multidisciplinary steering committee 
(MSC), and is used as the basis for recommendation development.\98\ The 
MSC is then asked to consider the evidence in depth and to formulate a 
recommendation.\99\ Recommendations, which include this evidence 
review, that are approved by 75 percent of the MSC are submitted to 
HRSA by December 1 of the given calendar year.\100\ If approved by HHS, 
acting through the HRSA Administrator, the WPSI Clinical Recommendation 
is added to the HRSA-Supported Guidelines.\101\ Thus, HRSA-Supported 
Guidelines, as currently developed, are evidence-informed. The proposed 
addition of the term ``evidence-informed'' in 26 CFR 54.9815-
2713(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv), and 45 CFR 
147.130(a)(1)(iv) would more precisely describe the process through 
which the HRSA-Supported Guidelines are established and ensure the 
Guidelines continue to be evidence-informed in the future.
---------------------------------------------------------------------------

    \94\ See WPSI's Methodology Summary at https://www.womenspreventivehealth.org/wp-content/uploads/WPSI-Methodology-1.pdf.
    \95\ Id.
    \96\ Id.
    \97\ Id.
    \98\ Id.
    \99\ Id.
    \100\ Id.
    \101\ Id.
---------------------------------------------------------------------------

    For these reasons, the Departments propose to codify that standard. 
The Departments do not anticipate that this proposed amendment would 
alter the existing processes through which the HRSA-Supported 
Guidelines are developed, as these processes, as stated previously, 
already include a robust consideration of evidence.
    The Departments seek comment on this proposal.
3. Conforming Edits
    As discussed in section II.C.2 of this preamble, the Departments 
also propose to eliminate the exemption for entities with moral 
objections to contraceptive coverage at 45 CFR 147.133, and therefore 
to also make conforming edits to remove references to 45 CFR 147.133 
that appear in paragraph (a)(1) of 45 CFR 147.130 and paragraph 
(a)(1)(iv) of 26 CFR 54.9815-2713, 29 CFR 2590.715-2713 and 45 CFR 
147.130. Finally, HHS proposes to remove from 45 CFR 147.130(a)(1) 
references to 45 CFR 147.131 and 45 CFR 147.132. Those references also 
appear in paragraph (a)(1)(iv), for the same purpose, and therefore are 
duplicative and unnecessary in 45 CFR 147.130(a)(1).

C. Exemptions in Connection With Coverage of Contraceptive Services (45 
CFR 147.132 and 147.133)

1. Religious Exemptions
    This proposed rule would maintain the religious exemption from the 
November 2018 Religious Exemption final rules. Each of the proposed 
changes made to the regulations with respect to religious objections is 
either technical in nature or codifies the intent specified in the 
preamble to the November 2018 Religious Exemption final rules. The 
proposed changes in no way narrow the scope of the exemption or further 
restrict the types of religious entities that may use the exemption.
    Under the regulations at 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 
2590.715-2713(a)(1)(iv), and 45 CFR 147.130(a)(1)(iv), a non-
grandfathered group health plan, or a health insurance issuer offering 
non-grandfathered group or individual health insurance coverage, must 
provide coverage for, and must not impose any cost-sharing requirements 
(such as a copayment, coinsurance, or a deductible) for, with respect 
to women, such additional preventive care and screenings as provided 
for in comprehensive guidelines supported by HRSA, subject to the 
exemptions and accommodations related to contraceptive coverage. The 
November 2018 Religious Exemption final rules at 45 CFR 147.132(a)(1) 
state that guidelines issued under 45 CFR 147.130(a)(1)(iv) by HRSA 
must not provide for or support the requirement of coverage or payments 
for contraceptive services with respect to a group health plan 
established or maintained by an objecting entity, to the extent of the 
objections specified in the regulations.
    The Departments note that the regulations require HRSA to include 
an exemption in its guidelines. Although the Supreme Court held in 
Little Sisters that the ACA ``gives HRSA broad discretion to define 
preventive care and screenings and to create the religious and moral 
exemptions,'' it also concluded that ``the plain language of the 
statute clearly allows the Departments to create the preventive care 
standards as well as the religious and moral exemptions'' 
102 103 (emphasis added). This is understandable because the 
HRSA Administrator exercises authority delegated from and subject to 
the control of the Secretary of HHS.\104\
---------------------------------------------------------------------------

    \102\ Little Sisters of the Poor Saints Peter and Paul Home v. 
Pennsylvania, 140 S. Ct. 2367, 2382 (2020); see also id. at 2374-75, 
2377-78 (recounting the Departments' history of deciding what should 
be included in the HRSA-Supported Guidelines).
    \103\ Exempting the types of objecting entities listed in the 
November 2018 final rules from any guideline requirements that 
relate to the provision of contraceptive services is consistent with 
the Departments' proposed requirement (discussed in section II.B of 
this preamble) that the comprehensive guidelines supported by HRSA 
be evidence-informed. The Departments interpret ``evidence-
informed'' to mean that the Guidelines must be informed by a 
consideration of scientific evidence; however, the implementation of 
the requirement with respect to group health plans or group or 
individual health insurance coverage can also take into account the 
Departments' decisions to provide religious exemptions.
    \104\ See 42 U.S.C. 202 (``The Public Health Service in the 
Department of Health and Human Services shall be administered by the 
Assistant Secretary for Health under the supervision and direction 
of the Secretary.''); Reorganization Plan No. 3 of 1966 Sec.  1, 5 
U.S.C. app 1 (transferring to the Secretary ``all functions of the 
Public Health Service, of the Surgeon General of the Public Health 
Service, and of all other officers and employees of the Public 
Health Service, and all functions of all agencies of or in the 
Public Health Service.''); Health Resources and Services 
Administration; Statement of Organization, Functions, and 
Delegations of Authority, 47 F. R. 38,409 (Aug. 31, 1982). Note that 
HHS is the successor of the U.S. Department of Health, Education, 
and Welfare, the latter of which is referenced in Reorganization 
Plan No. 3 of 1966 mentioned earlier in this footnote.
---------------------------------------------------------------------------

    Paragraph (a)(1)(i) through (iv) of 45 CFR 147.132 lists the types 
of objecting entities that are exempted from the HRSA-Supported 
Guideline requirements that relate to the provision of contraceptive 
services. These proposed rules would make minor technical amendments to 
45 CFR 147.132(a)(1)(i). That paragraph currently reads as follows: ``A 
group health plan and health insurance coverage provided in connection 
with a group health plan to the extent the non-governmental plan 
sponsor objects as specified in paragraph (a)(2) of this section. Such 
non-governmental plan sponsors include, but are not limited to, the 
following entities -.'' These proposed rules would add the phrase ``of 
the plan or coverage'' immediately following ``sponsor'' solely for 
purposes of precision and clarity. Additionally, these proposed rules 
would delete the phrase ``, but are not limited to,''. This change is 
not intended to limit the types of non-governmental plan sponsors that 
may avail themselves of the religious exemption as compared to the 
November 2018 Religious Exemption final rules, but is rather intended 
as a stylistic, grammatical change that is consistent with other 
regulations issued by the Departments.
    In addition, the proposed rules would add language in 45 CFR 
147.132(a)(1)(iv) clarifying that, notwithstanding the guaranteed 
availability requirements in 45 CFR 146.150 and 45 CFR 147.104, a 
health insurance issuer may not offer coverage that excludes some or 
all contraceptive services to any entity or individual that

[[Page 7248]]

is not an objecting entity or objecting individual. The preamble to the 
November 2018 final rules specified this prohibition with respect to 
exempt entities,\105\ but the provision was not included in the 
regulatory text. This prohibition would apply to all health insurance 
issuers, whether or not the issuer is an exempt or non-exempt entity. 
The Departments have identified no reason to treat exempt and non-
exempt issuers differently in this regard. This prohibition is 
important to ensure that entities and individuals that are not 
objecting entities or individuals are not offered coverage that 
excludes some or all contraceptive services from being provided without 
cost sharing. In addition, the Departments are of the view that this 
prohibition properly respects both the interests of ensuring that women 
have the opportunity to obtain coverage for contraceptive services 
without cost sharing and the interests of entities that have religious 
objections to offering contraceptive coverage. By allowing health 
insurance issuers to offer coverage that excludes some or all such 
contraceptive services to entities or individuals that have religious 
objections to involvement with contraceptive services, the November 
2018 final rules provided important protections to objecting entities 
and individuals. On the other hand, by limiting the individuals and 
entities to whom an objecting health insurance issuer can offer the 
coverage, the November 2018 final rules took critical steps to ensure 
that women employed by or who are students of entities that do not have 
an objection to coverage of contraceptive services (or women purchasing 
coverage in the individual market who do not have such an objection) 
continue to have access to contraceptive services as required under 26 
CFR 54.9815-2713, 29 CFR 2590.715-2713, and 45 CFR 147.130. These 
proposed regulations would codify this limitation in regulatory text.
---------------------------------------------------------------------------

    \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

[[Page 7249]]

whether this form of communication would be sufficient for an issuer to 
understand that it must fulfill its separate and independent obligation 
to provide coverage of contraceptive services. The Departments also 
seek comment on whether and how the health insurance issuer, in 
instances in which it does not have its own religious objection to 
covering contraceptive services, should be required to provide the 
contraceptive coverage, and what guardrails should be in place to 
separate the issuer's coverage of contraceptive services from the 
coverage provided under the insured group health plan or student health 
insurance coverage.
2. Moral Exemptions
    Under 45 CFR 147.133, the HRSA-Supported Guidelines must not 
provide for or support the requirement of coverage or payments for 
contraceptive services with respect to a group health plan established 
or maintained by an objecting organization, or health insurance 
coverage offered or arranged by an objecting organization, to the 
extent of the entity's objections, based on its sincerely held moral 
convictions, to its establishing, maintaining, providing, offering, or 
arranging for (as applicable) coverage or payments for some or all 
contraceptive services; or a plan, issuer, or third party administrator 
that provides or arranges such coverage or payments. Similarly, under 
45 CFR 147.133, the HRSA-Supported Guidelines must not provide for, or 
support, the requirement of coverage or payments for contraceptive 
services with respect to individuals who object to coverage or payments 
for some or all contraceptive services based on sincerely held moral 
convictions.
    These proposed rules would remove the ability of entities to claim 
an exemption to establishing, maintaining, providing, offering, or 
arranging for contraceptive coverage based on a non-religious moral 
objection, and would remove the exemption on the basis of moral 
convictions applicable to objecting individuals.
    As the Departments explained in the November 2018 Moral Exemption 
final rule, and as pointed out in section I.A of this preamble, the 
Departments' adoption of the moral exemptions was not legally required 
but rather an exercise of the Departments' discretion to protect moral 
convictions.\106\ Additionally, as noted in the November 2018 Moral 
Exemption final rules, the moral exemption likely affects very few 
individuals.\107\ In Little Sisters, the Supreme Court concluded that 
it was appropriate for HRSA to consider the prevalence of RFRA claims, 
and the possibility of required exemptions under RFRA, as a reason for 
establishing the religious exemption.\108\ The Departments have done 
so, and these proposed rules continue to provide exemptions for 
religious organizations, employers and institutions of higher 
education, and health insurance issuers with sincerely held religious 
objections to providing, sponsoring, or arranging coverage of 
contraceptive services.
---------------------------------------------------------------------------

    \106\ 83 FR 57592, 57598.
    \107\ 83 FR 57592, 57627. The November 2018 Moral Exemption 
final rules assumed that nine nonprofit entities and nine for-profit 
entities would avail themselves of the moral exemption, and 
estimated that approximately 15 women may incur contraceptive costs 
due to use of the moral exemption by for-profit entities.
    \108\ Little Sisters of the Poor Saints Peter and Paul Home v. 
Pennsylvania, 140 S. Ct. 2367 (2020).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \109\ Corporation of Presiding Bishop of Jesus Christ of Latter-
Day Saints v. 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.\110\ The Departments 
respectfully disagree with that conclusion: as noted previously, the 
reason for the distinction is that the Departments can account for the 
prospect of numerous RFRA claims with respect to a religious exemption, 
some of which might be meritorious, but there is no analogous need to 
heed the possibility of successful claims to a non-religious moral 
exemption, because there is no moral-exemption statute similar to RFRA.
---------------------------------------------------------------------------

    \110\ March for Life v. 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.\111\ These assumptions were made in the absence of data. 
Thus, the Departments seek comment on how many women lost contraceptive 
coverage without cost sharing based on the moral exemption rule, and 
how many would regain access to such coverage by rescinding the 
availability of the moral exemption. The Departments seek evidence of 
the quantitative harms from the moral exemption rule. The Departments 
note, however, that eliminating the moral exemption is likely justified 
even if more entities than previously estimated make use of the moral 
exemption.
---------------------------------------------------------------------------

    \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.\112\ Yet, 
although employees of these organizations may typically share the views 
of the organizations, it is not necessarily true that all employees of 
these organizations share all of these

[[Page 7250]]

views, and employees may share these views in general while wishing to 
make personal benefits elections that arguably conflict with certain 
organizational views. This is true regardless of how many, or how few, 
entities object to covering contraceptives based on a moral exemption. 
Furthermore, dependents covered under plans sponsored by these 
organizations may not share the views of these organizations and could 
not be required to share these views as a condition of employment, 
unless they are also employees of the organizations. It is now the 
Departments' view that the potential harm to these individuals was not 
adequately considered when the Departments adopted the November 2018 
Moral Exemption final rules. The Departments seek comment on the 
potential impact to these individuals.
---------------------------------------------------------------------------

    \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.' \113\
---------------------------------------------------------------------------

    \113\ 83 FR 57592, 57599 (internal citations removed).

    However, the Departments now find it significant that Congress 
chose not to apply those statutory provisions to private entities that 
typically do not accept funds from or do business with the government, 
that is, entities that are, in that respect, similar to sponsors of 
private group health plans.\114\ The Departments also note that the 
Church Amendments primarily address the imposition of employment 
responsibilities or personal service requirements that would infringe 
upon an individual's moral beliefs, which is not directly relevant to 
an employer's, college's or university's, or health insurance issuer's 
moral objections to contraceptive coverage. The Departments also find 
it significant that those statutory provisions were enacted before the 
Supreme Court's opinion in Dobbs. Given that decision and the 
consequent threat to women's access to abortion and their ability to 
exercise control over their reproductive health care decisions, it is 
now all the more critical that women have access to contraceptive 
coverage. In fact, the Departments noted in the November 2018 Moral 
Exemption final rules that ``[t]he Church Amendments were enacted in 
the wake of the Supreme Court's decision in Roe v. Wade.'' \115\ At 
that time, Congress was acting in an environment in which there were, 
or were about to be, fewer restrictions on reproductive health.
---------------------------------------------------------------------------

    \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

[[Page 7251]]

sharing.\116\ The Departments also seek comment on whether such an 
approach would introduce unwarranted barriers for women to access 
contraceptive services, as compared to simply eliminating the moral 
exemption.
---------------------------------------------------------------------------

    \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.\120\ The Departments are of the view that it would be 
appropriate to continue to require that, when making separate payments 
for contraceptive services through the optional accommodation for 
insured plans, an issuer must make those payments in a manner that is 
consistent with these patient protections. The Departments seek comment 
on the circumstances under which contraceptive services would 
constitute emergency services,\121\ as well as whether to continue to 
apply the protections for emergency services, which were set forth 
under section 2719A of the PHS Act, and subsequent to that provision 
sunsetting, are now set

[[Page 7252]]

forth in section 2799A-1 of the PHS Act but include different such 
protections, to issuers making separate payments for contraceptive 
services through the optional accommodation for insured plans.
---------------------------------------------------------------------------

    \119\ Title I of Division BB of the CAA is also known as the No 
Surprises Act.
    \120\ Section 2719A(b) of the PHS Act and the Departments' 
implementing regulations established requirements applicable to 
group health plans and health insurance issuers offering group or 
individual health insurance related to the coverage of emergency 
services, which are also covered under the CAA's sunset provision. 
The No Surprises Act added section 9816 of the Code, section 716 of 
ERISA, and section 2799A-1 of the PHS Act, which expand the patient 
protections related to emergency services under section 2719A of the 
PHS Act, in part, by providing additional consumer protections 
related to balance billing.
    \121\ The term emergency services is defined in regulations at 
26 CFR 54.9816-4T(c)(2), 29 CFR 2590.716-4(c)(2), and 45 CFR 
149.110(c)(2).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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 
v. Jackson Women's Health Organization. Specifically, the Departments 
propose to amend 26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A, and 45 
CFR 147.131 to create an individual contraceptive arrangement for women 
enrolled in a group health plan or health insurance coverage sponsored, 
offered, or arranged by an objecting entity that does not provide 
contraceptive coverage and that elects not to use the existing optional 
accommodations with respect to some or all contraceptive services. By 
enabling individuals to directly receive contraceptive services at no 
cost, this proposal would provide them with access to all contraceptive 
services the plan or coverage would otherwise be required to cover, 
absent the exemption. Critically, this would be accomplished 
independent of any action by the objecting entity, which would not be 
required to take any steps to facilitate this provision of 
contraceptive services.
    Under these proposed rules, an eligible individual may voluntarily, 
and independent of any actions by the objecting entity, elect this 
individual contraceptive arrangement. Under proposed 26 CFR 54.9815-
2713A(e), 29 CFR 2590.715-2713A(e), and 45 CFR 147.131(d), a provider 
of contraceptive services would furnish contraceptive services to the 
eligible individual without imposing any fee or charge of any kind, 
directly or indirectly, on the eligible individual or any other entity 
for the cost of the items and services or any portion thereof.\123\ The 
provider of

[[Page 7253]]

contraceptive services would be permitted to seek reimbursement from a 
participating issuer as defined under 45 CFR 156.50,\124\ with which 
the provider has a signed agreement for the costs of providing these 
contraceptive services. The Departments expect that administrative 
costs incurred by participating providers of contraceptive services 
would be included in the amounts they submit to issuers for 
reimbursement. The issuer in turn would be able to receive a reduction 
equal to this amount (plus an administrative allowance for costs and 
margin) to the issuer's FFE or SBE-FP user fees pursuant to 45 CFR 
156.50(d). See section III of this preamble for a discussion of how a 
provider of contraceptive services would be reimbursed through such an 
adjustment.
---------------------------------------------------------------------------

    \123\ Under these proposed rules, the provider of contraceptive 
services would furnish contraceptive services to the eligible 
individual in a manner that is totally independent of any costs that 
are associated with a group health plan or health insurance coverage 
sponsored, arranged, or provided by an objecting entity. The 
Departments note that, because the individual contraceptive 
arrangement would be completely separate from a plan or coverage 
sponsored, arranged, or provided by an objecting entity, the 
provision of the proposed rules that would require a provider of 
contraceptive services to furnish contraceptive services to eligible 
individuals without imposing any fee or charge of any kind would 
mean that the provider of contraceptive services would not collect 
any amounts that would typically be associated with an eligible 
individual's plan or coverage, such as any premiums, cost-sharing 
requirements, or other similar amounts.
    \124\ 45 CFR 156.50 defines participating issuer as any issuer 
offering a plan that participates in the specific function that is 
funded by user fees. This term may include: health insurance 
issuers, QHP issuers, issuers of multi-State plans (as defined in 45 
CFR 155.1000(a), issuers of stand-alone dental plans (as described 
in 45 CFR 155.1065), or other issuers identified by an Exchange.
---------------------------------------------------------------------------

    Participation in an individual contraceptive arrangement would be 
entirely voluntary for the provider of contraceptive services. A 
willing provider of contraceptive services would also be reimbursed for 
items and services that are integral to the furnishing of the 
contraceptive service, for an amount agreed to by the provider and 
eligible issuer, regardless of whether the provider would typically 
bill for the item or service separately. Reimbursing for the items and 
services that are integral to the furnishing of the contraceptive 
service, regardless of whether the provider would typically bill for 
the item or service separately, is consistent with how the Departments 
have interpreted section 2713 of the PHS Act as applied to group health 
plans and health insurance issuers offering group or individual health 
insurance coverage.\125\
---------------------------------------------------------------------------

    \125\ 85 FR 71142, 71174. See also FAQs about Affordable Care 
Act Implementation Part 54 (July 28, 2022), Q1, 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.
---------------------------------------------------------------------------

    For purposes of this individual contraceptive arrangement, these 
proposed rules would define an eligible individual under 26 CFR 
54.9815-2713A(a)(3), 29 CFR 2590.715-2713A(a)(3), and 45 CFR 
147.131(a)(3) as a participant or beneficiary enrolled in a group 
health plan established or maintained, or an enrollee in individual 
health insurance coverage offered or arranged, by an objecting entity 
described in 45 CFR 147.132(a) that, to the extent eligible, has not 
invoked the accommodation, and who confirms to a provider of 
contraceptive services (that agrees to meet certain criteria) that the 
individual is enrolled in a group health plan or group or individual 
health insurance coverage sponsored, provided, or arranged by an 
objecting entity that does not provide coverage for all or a subset of 
contraceptive services as generally required for non-objecting entities 
under 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv), 
and 45 CFR 147.130(a)(1)(iv).
    The individual may make this confirmation by producing any 
documentation that may include the relevant information, such as a 
summary of benefits (for example, a summary of benefits and coverage 
(SBC) that includes the relevant information), or through other 
methods, such as by providing an attestation.\126\ The provider of 
contraceptive services would have discretion on choosing what 
confirmation method to accept. The Departments seek comment on 
additional sources of information that participants, beneficiaries, and 
enrollees could provide for this confirmation, including what 
documentation plans and issuers may already be providing to 
participants, beneficiaries, and enrollees independent of any Federal 
requirements.
---------------------------------------------------------------------------

    \126\ The Departments are proposing to add sample attestation 
language for this purpose to the regulations at 26 CFR 54.9815-
2713A(e)(2), 29 CFR 2590.715-2713A(e)(2), and 45 CFR 147.131(d)(2).
---------------------------------------------------------------------------

    Excluded from the proposed definition of eligible individual are a 
participant or beneficiary enrolled in a group health plan established 
or maintained, or an enrollee in individual health insurance coverage 
offered or arranged, by an objecting entity that has invoked the 
optional accommodation. The Departments do not expect many such 
participants, beneficiaries, or enrollees would avail themselves of the 
individual contraceptive arrangement, even if they were eligible, as it 
would likely be easier for them to obtain contraceptive services 
through the accommodation. However, the Departments recognize that it 
may be challenging for an individual or a provider of contraceptive 
services to distinguish between an eligible individual, as defined 
under these proposed rules, and a participant or beneficiary enrolled 
in a group health plan established or maintained, or an enrollee in 
individual health insurance coverage offered or arranged, by an 
objecting entity that has invoked the optional accommodation. 
Therefore, the Departments seek comment on whether these individuals 
should be included within the definition of eligible individual.
    The Departments acknowledge that grandfathered health plans are not 
required to comply with section 2713 of the PHS Act, including the 
implementing regulations. However, because there are relatively few 
grandfathered plans and coverage still in existence,\127\ and these 
plans and issuers providing grandfathered coverage may voluntarily, or 
as required by State law, provide contraceptive coverage, the 
Departments are not proposing to apply the proposed individual 
contraceptive arrangement to women enrolled in grandfathered plans.
---------------------------------------------------------------------------

    \127\ In 2020, the Departments estimated that there are 2.5 
million ERISA-covered plans offered by private employers that cover 
an estimated 136.2 million participants and beneficiaries in those 
private employer-sponsored plans. Similarly, the Departments 
estimated that there were 84,087 State and local governments that 
offer health coverage to their employees, with an estimated 32.8 
million participants and beneficiaries in those employer-sponsored 
plans. The Departments estimated that, of firms offering health 
benefits, 400,000 sponsor ERISA-covered plans that are grandfathered 
(or include a grandfathered benefit package option) and cover 19.1 
million participants and beneficiaries. The Departments further 
estimated there are 13,454 State and local governments offering at 
least one grandfathered health plan and 4.6 million participants and 
beneficiaries covered by a grandfathered State or local government 
plan. See 85 FR 81097, 81108. The Departments expect that those 
numbers are now somewhat lower.
---------------------------------------------------------------------------

    These proposed rules, if finalized, would not place any additional 
obligations on a plan or health insurance issuer. Under this individual 
contraceptive arrangement, an exempt entity would not have to provide 
any verbal or written documentation to an eligible individual, a 
provider of contraceptive services, a health insurance issuer, a third 
party administrator, a government agency, or any other person or 
entity, that an exempt entity would not already be required to provide 
by virtue of sponsoring, arranging, or offering health coverage in 
general.\128\ Under these

[[Page 7254]]

proposed rules, an eligible individual may voluntarily, without the 
objecting entity's knowledge, and independent of any actions by the 
objecting entity, elect this individual contraceptive arrangement. The 
individual contraceptive arrangement option would therefore operate 
independently of any health plan or health insurance arrangement that 
involves or implicates an objecting entity. The Departments seek 
comment on adequate ways to ensure individuals are aware of the 
individual contraceptive arrangement, can learn if they are eligible, 
and can find participating providers to access contraceptive services 
at no cost.
---------------------------------------------------------------------------

    \128\ However, these proposed rules would not prohibit an 
eligible individual from requesting that the plan or coverage 
provide documentation showing the plan or coverage does not cover 
all or a subset of contraceptive services as generally required 
under 26 CFR 54.9815-2713(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv), 
or 45 CFR 147.130(a)(1)(iv). The Departments note that a plan or 
coverage would be required to comply with generally applicable 
disclosure requirements. For example, if an individual requests that 
the plan or coverage provide them with a copy of their SBC, the plan 
or coverage would be required to furnish the SBC in accordance with 
existing regulations. See 26 CFR 54.9815-2715(a)(1), 29 CFR 
2590.715-2715(a)(1), and 45 CFR 147.200(a)(1). Additionally, group 
health plans covered by ERISA are required to provide a summary plan 
description to participants and beneficiaries that describe, in 
terms understandable to the average plan participant, the rights, 
benefits, and responsibilities of participants and beneficiaries. 
See ERISA section 102 and 29 CFR 2520.104b-2.
---------------------------------------------------------------------------

    These proposed rules would also add a definition of provider of 
contraceptive services for purposes of 26 CFR 54.9815-2713A, 29 CFR 
2590.715-2713A, and 45 CFR 147.131 in new paragraphs 26 CFR 54.9815-
2713A(g)(2), 29 CFR 2590.715-2713A(g)(2), and 45 CFR 147.131(g)(2). The 
term ``provider of contraceptive services'' would mean any health care 
provider (including a clinician, pharmacy, or other facility) acting 
within the scope of that provider's license, certification, or 
authority under applicable law to provide contraceptive services. This 
definition is intended to be interpreted broadly to encompass any 
provider or facility authorized to provide any contraceptive services, 
including when provided via telehealth or mail. The Departments 
specifically seek comment on whether there are any entities that would 
be equipped to facilitate the individual contraceptive arrangement that 
would not be included within this definition.
    The Departments acknowledge that this proposal would not achieve 
the Women's Health Amendment's goal of ensuring that women have 
seamless cost-free coverage of contraceptives, because the individual 
contraceptive arrangement would require some additional action by the 
affected women and could require them to obtain contraceptive care from 
providers other than those from whom they typically receive women's 
health care. As the Departments have explained, however, they have been 
unable to identify a mechanism that would achieve seamless coverage 
while addressing the religious objections to the contraceptive coverage 
requirement and the existing accommodations as well as resolving the 
long-running litigation.\129\ Nonetheless, the proposed individual 
contraceptive arrangement would be more effective than the existing 
regulations at advancing the goals of the Women's Health Amendment, 
because the current regulations provide no pathway to obtain 
contraceptive services at no cost for women whose employers, 
institutions of higher education, or health insurance issuers exercise 
a religious exemption and either opt not to or are not eligible to 
invoke the accommodation.
---------------------------------------------------------------------------

    \129\ See FAQs Part 36, 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.
---------------------------------------------------------------------------

    The Departments propose to codify the proposed individual 
contraceptive arrangement in the same section of the regulations as the 
existing optional accommodation for exempt entities, as both would 
operate to ensure that women enrolled in coverage sponsored or offered 
or arranged by an exempt entity have access to contraceptive services 
otherwise required to be covered, without cost sharing. Therefore, the 
Departments propose to change the titles of 26 CFR 54.9815-2713A, 29 
CFR 2590.715-2713A, and 45 CFR 147.131 from ``Accommodations in 
connection with coverage of certain preventive health services,'' to 
``Alternate availability of certain preventive health services.''
    The Departments seek comment on all aspects of these proposed 
amendments.

III. Overview of Proposed Rules--Department of Health and Human 
Services

Financial Support (45 CFR 156.50)

    To facilitate the proposed individual contraceptive arrangement, 
HHS proposes to amend 45 CFR 156.50(d) to allow a participating issuer 
\130\ on the FFE or an SBE-FP to receive an FFE or SBE-FP user fee 
adjustment for reimbursing a provider of contraceptive services for the 
costs of providing contraceptive services pursuant to the individual 
contraceptive arrangement.\131\ Additionally, for purposes of 45 CFR 
156.50(a), HHS proposes that ``provider of contraceptive services'' 
would have the same meaning as ``provider of contraceptive services'' 
under proposed 45 CFR 147.131(g)(2). Under this definition, a provider 
of contraceptive services would not be required to be located in an FFE 
or SBE-FP State, but a participating issuer would need to be subject to 
FFE or SBE-FP user fees to be eligible to receive a user fee 
adjustment. In other words, a provider of contraceptive services would 
be able to seek reimbursement from a participating issuer in another 
State.
---------------------------------------------------------------------------

    \130\ Under 45 CFR 156.50(a), a participating issuer means any 
issuer offering a plan that participates in the specific function 
that is funded by user fees. This term may include: health insurance 
issuers, QHP issuers, issuers of multi-State plans (as defined in 45 
CFR 155.1000(a)), issuers of stand-alone dental plans (as described 
in 45 CFR 155.1065), or other issuers identified by an Exchange. The 
references to ``participating issuer'' in this section would mean a 
participating issuer on the FFE or an SBE-FP.
    \131\ HHS notes it is not proposing to change the substantive 
requirements on participating issuers and third party administrators 
when participating issuers make payments to third party 
administrators, nor is HHS proposing to make substantive changes 
related to information and documentation requirements on third party 
administrators and participating issuers that have made arrangements 
with each other. To conform with proposed changes for the individual 
contraceptive arrangement, HHS would amend 45 CFR 156.50 to include 
references to the individual contraceptive arrangement and re-
designate paragraphs to include references to the individual 
contraceptive arrangement provisions. These changes are discussed in 
more detail in the following paragraphs.
---------------------------------------------------------------------------

    To summarize, a provider of contraceptive services that incurs 
costs for furnishing contraceptive services pursuant to the individual 
contraceptive arrangement would be able to seek reimbursement of these 
costs from a participating issuer, with the issuer in turn receiving a 
reduction equal to this amount, plus an administrative allowance for 
costs and margin, of the issuer's FFE or SBE-FFP user fees as discussed 
in detail in this section of the preamble:
     In order to receive reimbursement for contraceptive 
services provided pursuant to the individual contraceptive arrangement, 
a provider of contraceptive services would be required to enter into a 
signed agreement with a participating issuer to reimburse the provider 
for the cost of furnishing contraceptive services.
     For the participating issuer to receive the user fee 
adjustment and for the provider of contraceptive services to receive 
reimbursement from the participating issuer as a result of the 
participating issuer's user fee adjustment, the participating issuer 
would be required to submit to HHS: (1) a copy of the signed agreement 
it entered into with the provider of

[[Page 7255]]

contraceptive services; (2) information that identifies the provider of 
contraceptive services it reimbursed or will reimburse; and (3) the 
total dollar amount of the payments it made or will make to reimburse 
the provider of contraceptive services for the costs of furnishing 
contraceptive services to eligible individuals pursuant to the 
individual contraceptive arrangement.
     If the necessary conditions are met, the participating 
issuer would receive an adjustment to its user fee obligation equal to 
the total amount of costs of furnishing contraceptive services for each 
provider of contraceptive services in accordance with the individual 
contraceptive arrangement, plus an allowance for administrative costs 
and margin.\132\ If the adjustment exceeds the user fees owed in the 
month of the initial adjustment or in any later month, any excess 
adjustment would be carried over to later months.
---------------------------------------------------------------------------

    \132\ The allowance for administrative costs and margin is 
intended to cover a participating issuer's administrative costs 
associated with reimbursing providers of contraceptive services, 
such as the costs associated with entering into arrangements with 
such providers and submitting documentation to seek a reduction in 
the user fee obligation, as well as provide a margin to ensure that 
participating issuers receive appropriate compensation for providing 
such reimbursements. See 78 FR 39870, 39884.
---------------------------------------------------------------------------

     Under these proposed rules and the current regulation, the 
administrative allowance--which would be at least 10 percent of the 
total dollar amount of the costs of furnishing contraceptive services 
pursuant to the individual contraceptive arrangement \133\--would be 
specified by HHS in the annual HHS notice of benefit and payment 
parameters or other rulemaking. If the administrative allowance for an 
applicable year is not specified in that year's HHS notice of benefit 
and payment parameters or other rulemaking, then the administrative 
allowance would be the amount last specified in rulemaking.
---------------------------------------------------------------------------

    \133\ Pursuant to 45 CFR 156.50(d)(3)(ii), the minimum 
administrative allowance permitted for the existing third party 
administrator optional accommodation is also at least 10 percent of 
the total dollar amount of payments for contraceptive services. See 
78 FR 39870, 39885. Per the HHS Notice of Benefit and Payment 
Parameters for 2015 (``2015 Payment Notice''), HHS set the 
administrative allowance for the existing third party administrator 
optional accommodation at 15 percent. See 79 FR 13743, 13809 (March 
11, 2014).
---------------------------------------------------------------------------

     The participating issuer may pay the provider of 
contraceptive services as soon as the contraceptive services are 
delivered pursuant to the individual contraceptive arrangement, but the 
participating issuer would be required to pay the provider, no later 
than within 60 days of receipt of any adjustment of a user fee. No 
payment would be required with respect to the allowance for 
administrative costs and margin. This proposal sets the latest date on 
which the participating issuer must reimburse the provider of 
contraceptive services. This proposal would not preclude the 
participating issuer and provider of contraceptive services from 
agreeing that the participating issuer would reimburse the provider at 
more frequent intervals, such as on a monthly or quarterly basis, or 
upfront for the full cost of services provided during the applicable 
benefit year rather than in the following benefit year in which the 
issuer receives the monthly user fee adjustment.
    Each of the items from the preceding list laying out this proposed 
user fee adjustment is discussed in more detail in the following 
paragraphs.
    HHS proposes to add paragraph (d)(1)(iii) to 45 CFR 156.50 to 
require that a provider of contraceptive services and a participating 
issuer enter into an agreement for that issuer to seek a user fee 
adjustment as a result of reimbursing the provider's costs pursuant to 
the individual contraceptive arrangement. An agreement between the 
participating issuer and the provider of contraceptive services would 
be a condition of participation in the individual contraceptive 
arrangement and required to receive reimbursement for the costs of 
furnishing contraceptive services.
    HHS proposes to amend 45 CFR 156.50(d)(2)(i) to establish the 
information and documentation a participating issuer that is eligible 
for a user fee adjustment must provide to HHS to receive a user fee 
adjustment as a result of reimbursement of (or intention to reimburse 
pursuant to proposed 45 CFR 156.50(d)(5)) the cost of furnishing 
contraceptive services incurred by a provider of contraceptive 
services. HHS proposes to amend 45 CFR 156.50(d)(2)(i)(A) to require 
that, to receive a user fee adjustment under the individual 
contraceptive arrangement, a participating issuer must submit to HHS 
identifying information on each provider of contraceptive services it 
reimbursed (or will reimburse pursuant to proposed 45 CFR 
156.50(d)(5)). Additionally, HHS proposes to add 45 CFR 
156.50(d)(2)(i)(D) and (E) to require the participating issuer offering 
a plan through the FFE or an SBE-FP to submit: (1) documentation that 
demonstrates that the participating issuer and the provider of 
contraceptive services have entered into an agreement through which the 
participating issuer would reimburse the provider for the costs of 
contraceptive services furnished under the individual contraceptive 
arrangement; and (2) the total dollar amount of the payments the 
participating issuer made (or will make) to reimburse the provider for 
the costs of furnishing those contraceptive services already provided 
under the individual contraceptive arrangement.
    To facilitate the individual contraceptive arrangement, HHS 
proposes that providers of contraceptive services and participating 
issuers, as a condition for participating in this individual 
contraceptive arrangement, must enter into a signed agreement and that 
the participating issuer must submit a copy of this agreement to HHS to 
satisfy the proposed submission requirements at 45 CFR 
156.50(d)(2)(i)(A) and (D). HHS proposes that this signed agreement 
must include identifying information of the provider of contraceptive 
services, such as the name and contact information for the provider's 
practice or facility or, if applicable, the provider's National 
Provider Identifier.\134\ In addition, the agreement would need to 
include the signatures of individuals with the authority to legally and 
financially bind the provider of contraceptive services and the 
participating issuer. The agreement would need to demonstrate that the 
provider of contraceptive services and participating issuer have 
entered into an arrangement through which the participating issuer will 
reimburse the provider for the costs of furnishing contraceptive 
services in accordance with the individual contraceptive arrangement at 
proposed 26 CFR 54.9815-2713A(e), 29 CFR 2590.715-2713A(e), and 45 CFR 
147.131(d), and that the participating issuer will seek a user fee 
adjustment for the amount of those eligible costs (plus an 
administrative allowance as specified at proposed 45 CFR 
156.50(d)(3)(iii)). HHS notes that other terms of the agreement between 
a provider of contraceptive services and a participating issuer, such 
as the period of time over which the agreement is effective, are at the 
discretion of the participating issuer and provider. HHS also notes 
that, to facilitate the individual contraceptive arrangement, a single 
participating issuer may enter into separate agreements with more than 
one provider of contraceptive services. Additionally, providers of 
contraceptive services may enter into separate agreements with more 
than one participating issuer. HHS recognizes that there may be 
additional

[[Page 7256]]

forms of documentation that could satisfy these proposed submission 
requirements; thus, HHS seeks comment on the types of documentation HHS 
should accept. HHS also seeks comment on the types of information 
participating issuers must submit to adequately identify the providers 
of contraceptive services with which the participating issuers have 
entered into such arrangements.
---------------------------------------------------------------------------

    \134\ See ``NPI: What You Need to Know'' (March 2021), available 
at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/NPI-What-You-Need-To-Know.pdf.
---------------------------------------------------------------------------

    HHS proposes to add 45 CFR 156.50(d)(2)(i)(E) to require a 
participating issuer to submit the total dollar amount of the 
provider's costs of furnishing contraceptive services under the 
individual contraceptive arrangement and for which a participating 
issuer would be able to receive a user fee adjustment (plus an 
administrative allowance as specified at proposed 45 CFR 
156.50(d)(3)(iii)). HHS recognizes that the costs of furnishing 
contraceptive services under the individual contraceptive arrangement 
would vary based on the specific contraceptive service provided and the 
time it takes to provide that service. Because of this cost variance, 
HHS proposes to allow a provider of contraceptive services to calculate 
its actual costs of furnishing these contraceptive services and to 
provide that calculation of actual costs to the participating issuer 
offering a plan through the FFE or an SBE-FP with which the provider 
has entered into an arrangement for reimbursement of these costs. 
Consistent with how the Departments have interpreted section 2713 of 
the PHS Act as applied to group health plans, and health insurance 
issuers offering group or individual health insurance coverage,\135\ 
HHS proposes that the actual costs of the provider of contraceptive 
services would include items and services that are integral to the 
furnishing of the contraceptive service, for an amount agreed to by the 
provider and eligible issuer, regardless of whether the provider would 
typically bill for the item or service separately. This would include 
the administrative costs incurred by participating providers of 
contraceptive services to deliver the contraceptive services. HHS seeks 
comment on the costs a provider of contraceptive services could include 
in its calculation of actual costs provided to the participating issuer 
with which it has entered into an arrangement for reimbursement of 
these costs. In determining how a provider's costs should be calculated 
for reimbursement under the individual contraceptive arrangement, HHS 
considered whether costs should be calculated using a standard 
methodology. However, due to the wide variation in costs depending on 
the specific contraceptive services provided and how the service is 
delivered, HHS determined that permitting a provider of contraceptive 
services to calculate its actual costs would allow the provider to 
receive a more accurate cost reimbursement. HHS seeks comment on 
whether the reimbursement should be equal to the provider's actual 
costs of furnishing contraceptive services to eligible individuals or 
whether HHS should instead establish a standard methodology to 
calculate costs. HHS seeks comment on benchmarks HHS could use to 
establish a reimbursement rate.
---------------------------------------------------------------------------

    \135\ 85 FR 71142, 71174. See also FAQs Part 54, Q1, 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.
---------------------------------------------------------------------------

    Additionally, HHS proposes to revise 45 CFR 156.50(d)(3)(ii) to 
permit a participating issuer that satisfies the requirements as 
proposed in 45 CFR 156.50(d)(2) to receive a user fee adjustment equal 
to the total dollar amount of a provider's costs of furnishing 
contraceptive services plus the administrative allowance. HHS proposes 
to re-designate the administrative allowance provision at existing 45 
CFR 156.50(d)(3)(ii) to new paragraph (d)(3)(iii), and amend it to 
establish that the allowance should be calculated as a percentage of 
the sum of the total dollar amount of the payments for contraceptive 
services provided to a third party administrator as calculated at 45 
CFR 156.50(d)(3)(i) and the provider's costs of furnishing 
contraceptive services as calculated at proposed 45 CFR 
156.50(d)(3)(ii). HHS is of the view that it is appropriate to provide 
an administrative allowance because participating issuers will incur 
additional administrative costs to providers of contraceptive services 
for the actual cost of furnishing contraceptive services. As 
established in the 2015 Payment Notice,\136\ the current administrative 
allowance is 15 percent for issuers that have entered into agreements 
with third party administrators to reimburse the cost of contraceptive 
services with respect to women getting non-contraceptive coverage 
through eligible organizations.\137\ Consistent with the 2015 Payment 
Notice administrative allowance for third party administrators, HHS 
proposes an administrative allowance of at least 10 percent for issuers 
that enter into agreements with providers of contraceptive services 
pursuant to the individual contraceptive arrangement. HHS proposes a 15 
percent administrative allowance for this adjustment, similar to the 
administrative allowance set in the 2015 Payment Notice for third party 
administrators.
---------------------------------------------------------------------------

    \136\ 79 FR 13743.
    \137\ 79 FR 13743 at 13809.
---------------------------------------------------------------------------

    Additionally, for clarification and consistency with current 
practice, HHS proposes to clarify at 45 CFR 156.50(d)(3)(iii) that, 
unless a new allowance for administrative costs and margin is specified 
in the applicable year's HHS notice of benefit and payment parameters 
or other rulemaking, HHS will, for a particular calendar year, maintain 
the allowance that was last specified in rulemaking. HHS believes this 
proposal makes clear the allowance and the mechanism HHS would use to 
propose any changes to the allowance. While HHS is proposing to 
maintain that the administrative allowance must be at least 10 percent, 
as set forth in the 2015 Payment Notice, the current, applicable 
administrative allowance is 15 percent.\138\ HHS is not proposing 
making changes to this percentage in this rulemaking.
---------------------------------------------------------------------------

    \138\ 79 FR 13743 at 13809.
---------------------------------------------------------------------------

    HHS also proposes to amend 45 CFR 156.50(d)(5) to provide that a 
participating issuer may provide payments for contraceptive services as 
soon as they are delivered, but must provide payments within 60 days to 
a third party administrator or a provider of contraceptive services. 
Such payments must be made within 60 days of receipt of any adjustment 
of a user fee in an amount that is no less than the portion of the 
adjustment attributable to the total dollar amount of the payments for 
contraceptive services submitted by the third party administrator or 
provider of contraceptive services. This proposed amendment to 45 CFR 
156.50(d)(5) is intended to clarify and codify in regulation the 
current policy as applied to the existing optional accommodation with 
respect to a third party administrator, as well as to extend this 
policy to providers of contraceptive services pursuant to the 
individual contraceptive arrangement. The adjustments to a 
participating issuer's user fee through the FFE or an SBE-FP for a 
given year are based on data submitted by third party administrators to 
HHS regarding the prior benefit year, and adjustments to a 
participating issuer's current user fee charges are made on a monthly 
basis based on the data received to date regarding the payments for 
contraceptive services from the prior year. For example, a

[[Page 7257]]

participating issuer and a provider of contraceptive services could 
agree that, prior to and in anticipation of receiving a user fee 
adjustment as specified at 45 CFR 156.50(d)(3), the participating 
issuer would reimburse the provider on a monthly or quarterly basis in 
an amount equal to the provider's costs of furnishing contraceptive 
services in accordance with the individual contraceptive arrangement. 
However, HHS notes that if any monthly user fee adjustment that a 
participating issuer receives does not cover the full costs of 
contraceptive services provided by the provider of contraceptive 
services or the full payment for contraceptive services made or 
arranged for by the third party administrator for the applicable 
benefit year, then the provider may not receive full reimbursement for 
all contraceptive services furnished during the applicable calendar 
year within 60 days of when the participating issuer has first received 
an adjustment to its FFE or SBE-FP user fee. Thus, HHS proposes that 
the signed agreement between a participating issuer and a provider of 
contraceptive services must define the terms for payment to the 
provider.
    Next, HHS proposes to amend 45 CFR 156.50(d)(6) to establish that, 
for 10 years following the calendar year for which the user fee 
adjustment is received, a participating issuer must retain 
documentation demonstrating that it timely paid each provider of 
contraceptive services for which it received any user fee adjustment. 
These proposals align with the existing recordkeeping requirements for 
a participating issuer under the third party administrator 
contraceptive user fee adjustment process.
    In addition, HHS proposes to add 45 CFR 156.50(d)(8) to establish 
recordkeeping requirements with which providers must comply as a 
condition of participating in the individual contraceptive arrangement. 
HHS proposes to require that, for 10 years following the contraceptive 
service being provided, providers of contraceptive services must 
maintain documentation showing the actual costs of furnishing 
contraceptive services in compliance with the requirements of the 
individual contraceptive arrangement and documentation supporting the 
total dollar amount of those costs, and must make this documentation 
available upon request to HHS, the HHS Office of the Inspector General, 
the Comptroller General, and their designees. This timeframe is similar 
to the standard used for third party administrators under the existing 
optional accommodation and the standards used for other Exchange 
programs. We solicit comment on this timeframe and whether the 
timeframe should be tied to the issuer payment instead of the timeframe 
from when the contraceptive service is being provided.
    As explained previously, an eligible individual would be able to 
access the individual contraceptive arrangement without the exempt 
entity providing any documentation to an issuer, third party 
administrator, or HHS. Nevertheless, a provider of contraceptive 
services seeking to furnish contraceptive services pursuant to the 
individual contraceptive arrangement would be required to confirm an 
individual's eligibility for the individual contraceptive arrangement. 
As explained earlier in this preamble, the individual may make this 
confirmation by producing a summary of benefits, such as an SBC that 
includes the relevant information or through other methods, such as by 
providing an attestation. The provider of contraceptive services would 
have discretion on choosing what confirmation method to accept. HHS 
expects that providers would choose to document receiving this 
representation in a variety of ways, such as by making a notation in a 
specific eligible individual's medical chart. HHS is of the view that 
allowing providers of contraceptive services to choose how they 
document an eligible individual's representation would decrease 
operational barriers related to these recordkeeping requirements and 
would thereby allow a greater number of interested providers to furnish 
contraceptive services under the individual contraceptive arrangement.
    Recognizing the various types of representations a provider of 
contraceptive services could receive from or on behalf of an individual 
to demonstrate that individual's eligibility for the individual 
contraceptive arrangement, HHS proposes to add 45 CFR 156.50(d)(9) and 
(10). These proposals would preserve, if certain reliance requirements 
are met, a provider's ability to receive reimbursement for 
contraceptive services furnished, as well as a participating issuer's 
ability to receive a user fee adjustment, if the representation as to 
the individual's eligibility for the individual contraceptive 
arrangement is later determined to be incorrect. Specifically, proposed 
45 CFR 156.50(d)(9) would establish that if a provider of contraceptive 
services relies reasonably and in good faith on a representation that 
the individual is eligible to receive contraceptive services pursuant 
to the individual contraceptive arrangement, and the representation is 
later determined to be incorrect, then the provider of contraceptive 
services would be considered to have received a representation by an 
eligible individual for purposes of receiving a reimbursement for 
contraceptive services furnished by a participating issuer, and would 
meet any requirements related to maintaining documentation of this 
representation. Similarly, 45 CFR 156.50(d)(10), if finalized, would 
establish that if a participating issuer relies reasonably and in good 
faith on the provider's representation that the provider of 
contraceptive services furnished contraceptive services for an eligible 
individual, and the representation the provider received from or on 
behalf of the individual is later determined to be incorrect, then the 
participating issuer would meet any requirements that involve the 
provider's receipt of such representation.
    HHS also proposes to add 45 CFR 156.50(d)(11) to preserve, if 
certain requirements are met, the ability of a participating issuer to 
receive a user fee adjustment if the provider's representation to the 
participating issuer that the provider furnished contraceptive services 
in accordance with the individual contraceptive arrangement is later 
determined to be incorrect. First, proposed 45 CFR 156.50(d)(11) would 
establish that if a participating issuer relies reasonably and in good 
faith on a provider's representation that the provider furnished 
contraceptive services in accordance with the individual contraceptive 
arrangement, and the representation by the provider of contraceptive 
services is later determined to be incorrect, then the participating 
issuer's good faith reliance on that incorrect representation would 
meet any requirements that involve that representation. Second, the 
proposal at 45 CFR 156.50(d)(11) would apply only when a participating 
issuer has already reimbursed a provider of contraceptive services for 
any amount of its costs of furnishing contraceptive services as 
specified in proposed 45 CFR 156.50(d)(2)(i)(E). HHS is of the view 
that it is appropriate to limit this proposal to instances in which the 
participating issuer has already paid the provider of contraceptive 
services. If the participating issuer has not yet paid the provider of 
contraceptive services at the time the provider's representation is 
determined to be incorrect, the participating issuer will not have 
incurred a financial loss by no longer having the ability to receive a 
user fee adjustment.

[[Page 7258]]

    To participate in the individual contraceptive arrangement, 
proposed 45 CFR 147.131(d)(1) would require that a provider of 
contraceptive services furnish contraceptive services to the eligible 
individual without imposing a fee or charge of any kind, directly or 
indirectly, on the eligible individual or any other entity for the cost 
of the items and services or any portion thereof. Consistent with this 
requirement, HHS proposes to include in new 45 CFR 156.50(d)(1)(iii), 
(d)(10), and (d)(11) that a provider of contraceptive services must 
furnish contraceptive services to the eligible individual ``without 
imposing a fee or charge of any kind, directly or indirectly, on the 
eligible individual or any other entity for the cost of the items and 
services or any portion thereof.''
    Finally, HHS proposes technical corrections to 45 CFR 
156.50(d)(1)(ii), (d)(2)(i)(A) and (B), (d)(2)(ii), (d)(2)(iii)(B), and 
(d)(7)(i) to align with these proposed changes. First, HHS proposes a 
technical correction to 45 CFR 156.50(d)(1)(ii), (d)(2)(i)(A) and (B), 
(d)(2)(ii), (d)(2)(iii)(B), and (d)(7)(i) to update cross-references to 
26 CFR 54.9815-2713A(a)(4) and 29 CFR 2590.715-2713A(a)(4), which have 
been re-designated to 26 CFR 54.9815-2713A(a)(1)(iii) and 29 CFR 
2590.715-2713A(a)(1)(iii), respectively. Second, HHS proposes a 
technical correction to 45 CFR 156.50(d)(1)(ii) to clarify that a 
participating issuer participating on an SBE-FP is eligible to receive 
an adjustment to its Federal user fee amounts that reflect the value of 
contraceptive services it has agreed to reimburse to third party 
administrators or has agreed to reimburse to providers for the 
providers' actual costs of furnishing contraceptive services consistent 
with this individual contraceptive arrangement. In the HHS Notice of 
Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager 
Standards final rule,\139\ HHS explained that issuers participating 
through an SBE-FP have been able to qualify for user fee adjustments as 
provided for in the HHS Notice of Benefit and Payment Parameters for 
2017,\140\ and amended 45 CFR 156.50 to make explicit that issuers are 
eligible to receive SBE-FP user fee adjustments.\141\ Thus, HHS 
proposes to make a conforming amendment to 45 CFR 156.50(d)(1)(ii).
---------------------------------------------------------------------------

    \139\ 86 FR 24140 at 24229 (May 5, 2021).
    \140\ 81 FR 12203 at 12293 (March 8, 2016).
    \141\ 86 FR 24229.
---------------------------------------------------------------------------

    HHS notes that it is not proposing to raise the FFE or SBE-FP user 
fee rates finalized in the HHS Notice of Benefit and Payment Parameters 
for 2023 \142\ to offset the FFE and SBE-FP user fee adjustments, and 
HHS estimates reimbursements for contraceptive services will represent 
only a small portion of total FFE user fees.
---------------------------------------------------------------------------

    \142\ See 87 FR 27208 at 27288. In part 3 of the HHS Notice of 
Benefit and Payment Parameters 2022 final rule, HHS finalized the 
repeal of the Exchange Direct Enrollment (DE) option and the removal 
of 45 CFR 155.221(j). See 86 FR 53412 at 53429 (September 27, 2021). 
To align with these actions, HHS finalized in the 2023 Payment 
Notice conforming amendments to 45 CFR 156.50(c) and (d) to remove 
references to 45 CFR 155.221(j) and the Exchange DE option.
---------------------------------------------------------------------------

    HHS is of the view that the proposed amendment to 45 CFR 
156.50(d)(2)(i)(A) and the proposed addition of 45 CFR 
156.50(d)(2)(i)(D), which would require participating issuers, but not 
providers of contraceptive services, to submit documentation 
demonstrating the agreement, would mitigate the operational burden on 
providers of providing contraceptive services through the individual 
contraceptive arrangement, without materially increasing the burden for 
participating issuers that are already familiar with the process of 
submitting information to HHS as part of the existing conditions for 
receiving a user fee adjustment through an arrangement with a third 
party administrator, pursuant to the requirements of 45 CFR 156.50(d). 
To facilitate the individual contraceptive arrangement, HHS proposes to 
make available to providers of contraceptive services a list of 
participating issuers that have previously participated in the third 
party administrator optional contraceptive user fee adjustment process 
under current 45 CFR 156.50(d). HHS seeks comment on this proposal, 
including whether prior participating issuers or issuers that intend to 
participate in these arrangements in future years would have concerns 
with HHS making this public disclosure. HHS seeks comment on the 
proposed amendments to 45 CFR 156.50(d).
    As mentioned in section I.B of this preamble, section 3 of E.O. 
14009 directs HHS and other heads of agencies to review all agency 
actions, such as the FFE or SBE-FP user fees, to determine whether they 
are inconsistent with policy priorities described in section 1 of E.O. 
14009, to include protecting and strengthening the ACA and making high-
quality health care accessible and affordable for all individuals.\143\ 
Collectively, these proposed rules on the user fee adjustment would 
further the goals of E.O. 14009 by making high-quality health care that 
is inclusive of contraceptive services accessible and affordable for 
more individuals. Under the current rules, participants, beneficiaries, 
and enrollees enrolled in a group health plan or coverage sponsored, 
arranged, or provided by an objecting entity subject to a moral 
exemption lack contraceptive coverage and access to contraceptive 
services without cost sharing. The Departments lack the data to 
accurately estimate the number of, or demographics of, participants, 
beneficiaries, or enrollees who have been affected by previous rules, 
as objecting employers, institutions of higher education, and issuers 
are not required to notify HHS of their objection. However, as 
discussed earlier in this preamble, low-income women face a 
disproportionate burden of out-of-pocket spending on contraceptive 
services.\144\
---------------------------------------------------------------------------

    \143\ 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.
    \144\ See FN 54.
---------------------------------------------------------------------------

    Also, as noted in section I.B, section 3 of E.O. 14076 requires the 
Secretary of HHS to submit a report to the President that is focused 
on, among other priorities, ``protect[ing] and expand[ing] access to 
the full range of reproductive healthcare services, including actions 
to enhance family planning services such as access to emergency 
contraception,'' and ``promoting awareness of and access to the full 
range of contraceptive services.'' Collectively, these proposed rules 
are consistent with the objectives of E.O. 14076 by protecting and 
expanding access to the full range of reproductive health care services 
and enhancing family planning services, and promoting access to the 
full range of contraceptive services.

IV. Severability

    It is the Departments' intent that if any provision of these 
proposed rules, if finalized, is held to be invalid or unenforceable by 
its terms, or as applied to any person or circumstance, the rules shall 
be construed so as to continue to give maximum effect to the rules as 
permitted by law, unless the holding shall be one of utter invalidity 
or unenforceability. In the event a provision is found to be utterly 
invalid or unenforceable, the provision shall be severable from these 
proposed rules as finalized, as well as the final rules they amend, and 
shall not affect the remainder thereof or the application of the 
provision to persons not similarly situated or to dissimilar 
circumstances.

[[Page 7259]]

V. Response to Comments

    Because of the large number of public comments that the Departments 
normally receive on Federal Register documents, the Departments are not 
able to acknowledge or respond to them individually. The Departments 
will consider all comments received by the date and time specified in 
the DATES section of this preamble, and, when the Departments proceed 
with a subsequent document, the Departments will respond to the 
comments in the preamble to that document.

VI. Economic Impact and Paperwork Burden

A. Summary

    These proposed rules would expand access to contraceptive services 
without cost sharing for women through the provision of a new 
individual contraceptive arrangement, whereby an eligible individual 
would be able to obtain contraceptive services from willing providers 
of contraceptive services at no cost to the individual, and the 
providers of contraceptive services would be reimbursed for the costs 
of furnishing contraceptive services by a participating issuer on the 
FFE or an SBE-FP through an adjustment to the FFE or SBE-FP user fee 
for the participating issuer. These proposed rules would maintain the 
existing exemptions and optional accommodations for eligible entities 
and individuals claiming a religious objection to providing 
contraceptive coverage.
    These proposed rules would also expand access to contraceptive 
services without cost sharing by eliminating the exemption for entities 
and individuals that object to contraceptive coverage based on non-
religious moral beliefs.
    The Departments have examined the effects of these proposed rules 
as required by Executive Order 13563 (76 FR 3821, January 21, 2011, 
Improving Regulation and Regulatory Review); Executive Order 12866 (58 
FR 51735, October 4, 1993, Regulatory Planning and Review); the 
Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354); 
section 1102(b) of the Social Security Act (42 U.S.C. 1102(b)); section 
202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995, Pub. 
L. 104-4); Executive Order 13132 (64 FR 43255, August 10, 1999, 
Federalism); and the Congressional Review Act (5 U.S.C. 804(2)).

B. Executive Orders 12866 and 13563

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). Executive Order 13563 is 
supplemental to and reaffirms the principles, structures, and 
definitions governing regulatory review as established in Executive 
Order 12866.
    Section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule: 
(1) having an annual effect on the economy of $100 million or more in 
any 1 year, or adversely and materially affecting a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local or Tribal governments or communities 
(also referred to as ``economically significant''); (2) creating a 
serious inconsistency or otherwise interfering with an action taken or 
planned by another agency; (3) materially altering the budgetary 
impacts of entitlement grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raising novel 
legal or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects (for example, $100 million or 
more in any one year), and a ``significant'' regulatory action is 
subject to review by the Office of Management and Budget (OMB). The 
Departments anticipate that this regulatory action is not likely to 
have economic impacts of $100 million or more in at least 1 year and is 
therefore not expected to be economically significant under Executive 
Order 12866. OMB has determined, however, that the actions are 
significant within the meaning of section 3(f)(4) of the Executive 
Order. Therefore, the Departments have provided an assessment of the 
potential costs, benefits, and transfers associated with these proposed 
rules. In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by OMB.
1. Need for Regulatory Action
    Previous rules, regulations, and court decisions have left many 
women without contraceptive coverage and access to contraceptive 
services without cost sharing. These proposed rules, if finalized, seek 
to resolve the long-running litigation with respect to religious 
objections to providing contraceptive coverage, by honoring the 
objecting entities' religious objections, while also ensuring that 
women enrolled in a group health plan established or maintained, or in 
health insurance coverage offered or arranged, by an objecting entity 
described in 45 CFR 147.132(a) have the opportunity to obtain 
contraceptive services at no cost. These proposed rules would also 
eliminate the exemption for entities and individuals that object to 
contraceptive coverage based on non-religious moral beliefs, which 
prevents access to contraceptive services without cost sharing.
2. Summary of Impacts
    These proposed rules would expand access to contraceptive services 
without cost sharing and reduce out-of-pocket spending on contraceptive 
services for individuals eligible for the individual contraceptive 
arrangement. Issuers that reimburse providers of contraceptive services 
for the costs of furnishing contraceptive services for individuals 
eligible for the individual contraceptive arrangement and in turn seek 
an adjustment to the FFE or SBE-FP user fee would incur administrative 
costs, which would be offset by Federal payments in the form of user 
fee adjustments. Providers of contraceptive services would also incur 
administrative costs associated with furnishing the contraceptive 
services and entering into a signed agreement with a participating 
issuer on the FFE or an SBE-FP to receive reimbursement for the 
contraceptive services furnished, and individuals might incur costs 
related to finding providers of contraceptive services willing to 
participate in the program.
    These proposed rules would also expand access to contraceptive 
services without cost sharing and reduce out-of-pocket spending on 
contraceptive services for individuals by eliminating the exemption for 
entities and individuals that object to contraceptive coverage based on 
non-religious moral beliefs. However, as noted later in the Transfers 
discussion of this section the Departments do not have information on 
the number of entities and individuals that have claimed a moral 
exemption to providing contraceptive coverage, and are therefore 
uncertain of the amount of the potential transfer from plans and 
issuers to participants, beneficiaries, and enrollees due to reduced 
out-of-pocket spending on contraceptive services associated with the 
proposed elimination of the exemption for entities and individuals that 
object to contraceptive coverage based on non-religious moral beliefs.
    In accordance with Executive Order 12866, the Departments are of 
the view

[[Page 7260]]

that the benefits of this regulatory action justify the costs. The 
expected benefits, costs, and transfers associated with these proposed 
rules are summarized in Table 1 and discussed in detail later in this 
section.

                                            Table 1--Accounting Table
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Benefits:
Qualitative:
     Expansion of access to contraceptive services without cost sharing for eligible individuals through
     the creation of a new individual contraceptive arrangement.................................................
     Expansion of access to contraceptive services without cost sharing for participants, beneficiaries,
     and enrollees through the elimination of the exemption for entities and individuals that object to
     contraceptive coverage based on non-religious moral beliefs................................................
     Potential increase in health equity, given the expected reduction in out-of-pocket spending on
     contraceptive services by individuals......................................................................
     Potential reduction in unintended pregnancies and improved health outcomes for individuals.........
----------------------------------------------------------------------------------------------------------------
Costs:                                              Estimate      Year dollar    Discount rate   Period covered
                                                   (million)                         (percent)
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($/year)...............          $30.11             2022                7        2023-2027
                                                       30.11             2022                3        2023-2027
----------------------------------------------------------------------------------------------------------------
Quantitative:
     Administrative costs of approximately $4.7 million annually to participating providers of
     contraceptive services related to signing agreements with issuers. These costs would likely be included in
     the service charges of providers of contraceptive services and ultimately incurred by the Federal
     Government.................................................................................................
     Administrative costs of approximately $14.5 million annually to participating providers of
     contraceptive services associated with verifying eligibility for the proposed individual contraceptive
     arrangement, submitting amounts to participating issuers on the FFE or an SBE-FP to receive reimbursement
     for the contraceptive services furnished, and maintaining records. These costs would likely be included in
     the service charges of providers of contraceptive services and ultimately incurred by the Federal
     Government.................................................................................................
     Administrative costs and margin of approximately $10.4 million annually to participating issuers
     associated with signing agreements with participating providers of contraceptive services, processing
     amounts requested from participating providers of contraceptive services, submitting required information
     to HHS, and maintaining records. These administrative costs would be offset by Federal payments in the form
     of adjustments to FFE and SBE-FP user fees.................................................................
     Costs of approximately $590,077 annually to eligible individuals that participate in the individual
     contraceptive arrangement to confirm eligibility to their provider of contraceptive services...............
----------------------------------------------------------------------------------------------------------------
Qualitative:
     Potential costs to eligible individuals associated with finding providers of contraceptive services
     that are willing to participate in the individual contraceptive arrangement................................
     Potential reduction in health care costs due to a reduction in unintended pregnancies and improved
     health outcomes............................................................................................
     Potential cost savings to states associated with reduced spending on State-funded programs that
     provide contraceptive services.............................................................................
     Potential cost savings to states associated with a reduction in unintended pregnancies that would
     otherwise impose costs to states...........................................................................
----------------------------------------------------------------------------------------------------------------
Transfers:                                          Estimate      Year dollar    Discount rate   Period covered
                                                   (million)                         (percent)
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($/year)...............           $49.9             2022                7        2023-2027
                                                        49.9             2022                3        2023-2027
----------------------------------------------------------------------------------------------------------------
Quantitative:
     Transfer of $49.9 million annually from the Federal Government to eligible individuals who would
     spend less out-of-pocket on contraceptive services, in the form of user fee adjustments to participating
     issuers who would reimburse providers of contraceptive services for the costs of furnishing participants,
     beneficiaries, and enrollees with contraceptive services as a result of the individual contraceptive
     arrangement................................................................................................
----------------------------------------------------------------------------------------------------------------
Qualitative:
     Potential transfer from plans and issuers to participants, beneficiaries, and enrollees who would
     gain access to contraceptive services without cost sharing as a result of the elimination of the exemption
     for entities and individuals that object to contraceptive coverage based on non-religious moral beliefs and
     who spend less out-of-pocket on contraceptive services as a result.........................................
----------------------------------------------------------------------------------------------------------------

Number of Affected Entities
    The Departments lack the data to accurately estimate the number of 
eligible individuals who would participate in the individual 
contraceptive arrangement. In the October 2017 Religious Exemption 
interim final rules and the November 2018 Religious Exemption final 
rules, the Departments noted that the 122 nonprofit entities that had 
filed litigation challenging the accommodation process and the 87 
closely held for-profit entities that had filed suit challenging the 
contraceptive coverage requirement in general could have been affected 
by the November 2018 Religious Exemption final rules, but were 
uncertain how many of these organizations would use the expanded 
exemption provided under the November 2018 Religious Exemption final 
rules and how many of these entities would use the optional 
accommodation process. The Departments assumed that slightly more than 
half of these entities, or 109 organizations, would use the expanded 
exemption.
    The Departments previously estimated that between 70,500 and 
126,400 individuals would be affected by the November 2018 Religious 
Exemption final rules. Since the implementation of the November 2018 
Religious Exemption final rules, additional entities may have claimed a 
religious exemption to contraceptive coverage without participating in 
the

[[Page 7261]]

optional accommodation process. For this reason, the Departments view 
the estimate of 126,400 individuals to be the lower bound estimate of 
the number of eligible individuals and 109 health plans to be the lower 
bound estimate of the number of exempt entities. The Departments seek 
comment on the number of entities that have claimed a religious 
exemption to providing contraceptive coverage without using the 
optional accommodation process and the number of individuals who might 
receive contraceptive coverage through the provision of the individual 
contraceptive arrangement.
    Eligible individuals would need to find providers of contraceptive 
services that would be willing to participate in the individual 
contraceptive arrangement. The Departments lack sufficient information 
to accurately estimate the number of providers of contraceptive 
services that would participate. The Departments assume that at least 
10 pharmacy chains (including mail order pharmacies) would participate. 
The Departments also assume that for each exempt entity, the 
participants, beneficiaries, and enrollees in its health plan or 
coverage are located in the same geographical area, and there would be, 
on average, 20 providers of contraceptive services (10 clinicians or 
facilities, and at least 10 retail pharmacies) in the area that would 
participate in the individual contraceptive arrangement.\145\ Based on 
these assumptions, for the participants, beneficiaries, and enrollees 
in the plans for the 109 exempt entities, there would be approximately 
2,180 participating providers of contraceptive services (1,090 retail 
pharmacies and 1,090 clinicians and facilities) that would participate 
in the individual contraceptive arrangement. If these providers of 
contraceptive services already participate in the health plan's 
provider network, an eligible individual would be able to receive 
contraceptive services from one of their regular providers of 
contraceptive services or another in-network provider of contraceptive 
services. However, it is possible that an eligible individual would 
need to find a provider of contraceptive services other than the 
provider or providers from whom the individual typically receives care 
in order to access contraceptive services at no cost. The Departments 
seek comment on the number of providers of contraceptive services that 
would participate in the individual contraceptive arrangement.
---------------------------------------------------------------------------

    \145\ Although pharmacies are generally licensed as facilities, 
for purposes of this regulatory impact analysis, the Departments 
treat them separately.
---------------------------------------------------------------------------

    These proposed rules would also eliminate the exemption for 
entities and individuals that object to contraceptive coverage based on 
non-religious moral beliefs. 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 non-
religious moral objections, the Departments assumed that the exemption 
would be used by nine nonprofit entities and nine for-profit entities 
and that approximately 15 women may incur contraceptive costs due to 
for-profit entities using the moral exemption. The Departments do not 
have any data on how many individuals object to contraceptive coverage 
based on non-religious moral beliefs.
Benefits
    These proposed rules would increase access to contraceptive 
services without cost sharing through the individual contraceptive 
arrangement for eligible individuals and the elimination of the 
exemption for entities and individuals that object to contraceptive 
coverage based on non-religious moral beliefs.
    As stated in section I.B of this preamble, 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. Prior to the implementation of the ACA, out-of-
pocket expenses for contraceptive services represented a significant 
portion, estimated to range from 30 percent to 44 percent, of a woman's 
total out-of-pocket health care spending.\146\ It has been estimated 
that the implementation of the ACA contraceptive coverage requirement 
led to out-of-pocket savings to consumers on contraceptive pills of 
approximately $1.4 billion between 2012 and 2013.\147\ Additionally, 
several studies have found that the ACA contraceptive coverage 
requirement increased access to and utilization of contraceptives.\148\ 
The coverage of contraceptive services has been shown to improve the 
consistent use of the most effective short-acting methods of 
contraception, and the removal of cost sharing also increases the use 
of more effective LARC methods.\149\ One study found that following the 
implementation of the ACA contraceptive coverage requirement, the 
discontinuation of use of oral contraceptive pills fell and that 
nonadherence to brand-name oral contraceptive pills also declined.\150\ 
Another study reported that having no copayment on contraceptive 
services assisted 80 percent of women in affording and using birth 
control, helped 60 percent choose a better method, and helped 71 
percent use contraceptive services more consistently.\151\ These 
proposed rules would have similar effects, as they would increase 
access to contraceptive services for eligible individuals who currently 
do not have access to contraceptive services without cost sharing.
---------------------------------------------------------------------------

    \146\ Nora B. & Polsky, D. (2015). ``Women Saw Large Decrease in 
Out-Of-Pocket Spending for Contraceptives After ACA Mandate Removed 
Cost Sharing.'' Health Affairs; 34(7): 1204-1211.
    \147\ Becker, N. & Polsky, D. (2015). ``Women Saw Large Decrease 
In Out-Of-Pocket Spending For Contraceptives After ACA Mandate 
Removed Cost Sharing.'' Health Affairs, 34(7): 1204-1211. See also 
Sobel, L., Salganicoff, A. et al. (2018). ``New Regulations 
Broadening Employer Exemptions to Contraceptive Coverage: Impact on 
Women.'' KFF Issue Brief. Available at https://www.kff.org/health-reform/issue-brief/new-regulations-broadening-employer-exemptions-to-contraceptive-coverage-impact-on-women/.
    \148\ Becker, N. (2018). ``The Impact of Insurance Coverage on 
Utilization of Prescription Contraceptives: Evidence from the 
Affordable Care Act.'' Journal of Policy Analysis and Management, 
37(3): 571-601; Nora, B., Keating, N. et al. (2021). ``ACA Mandate 
Led to Substantial Increase in Contraceptive Use Among Women 
Enrolled in High-Deductible Health Plans.'' Health Affairs, 40(4): 
579-586; Snyder, A., Weisman, C., et al. (2018). ``The Impact of the 
Affordable Care Act on Contraceptive Use and Costs among Privately 
Insured Women.'' Women's Health Issues, 28(3): 219-223; Weisman, C., 
Chuang, C., et al. (2019). ``ACA's Contraceptive Coverage 
Requirement: Measuring Use and Out-of-Pocket Spending.'' Health 
Affairs, 38(9): 1537-1541.
    \149\ 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.
    \150\ Pace, L., Dusetzina, S., et al. (2016). ``Early Impact of 
the Affordable Care Act on Oral Contraceptive Cost Sharing, 
Discontinuation, and Nonadherence.'' Health Affairs, 35(9): 1616-
1624.
    \151\ Bearak, J.& Johns, R. (2017). ``Did Contraceptive Use 
Patterns Change after the Affordable Care Act? A Descriptive 
Analysis.'' Women's Health Issues, 27(3): 316-321.
---------------------------------------------------------------------------

    More than half of pregnancies in 2008 (51 percent or approximately 
3.4 million) were estimated to be unintended; by 2011 this number had 
declined to 45 percent,\152\ and by 2020 it had declined further to an 
estimated 39.5 percent,\153\ which may be due to a change in the 
frequency and type of contraceptive use over time. Studies indicate 
that some groups tend to have higher rates of unintended pregnancies;

[[Page 7262]]

for example, one study found that 75 percent of pregnancies among teens 
aged 15 to 19 years of age were unplanned,\154\ and another study 
reported that nearly 70 percent of pregnancies among unmarried women 
aged 20 to 29 years of age were unplanned.\155\ In 2008, unplanned 
pregnancies of those covered by Medicaid or the Children's Health 
Insurance Program (CHIP) were estimated to have cost Federal and State 
taxpayers between $9.6 billion and $12.6 billion, and without publicly 
funded family planning the costs would have been an estimated $25 
billion.\156\ In addition to the costs associated with unintended 
pregnancies, unintended pregnancies can pose increased health risks to 
both mother and baby. Women with unplanned pregnancies are less likely 
to receive prenatal care and have higher rates of postpartum depression 
and mental health problems later in life.\157\ Unplanned pregnancies 
have also been associated with increases in low birthweight and preterm 
births, and children born due to an unplanned pregnancy are more likely 
to fare worse in school achievement, have social and emotional 
disorders, and have less success in the labor market later in 
life.\158\ One study found evidence of a decrease in births following 
the elimination of cost sharing for contraceptives under the ACA; 
further, it showed a 22.2 percent reduction in birth rates for women in 
the lowest income group between 2014 and 2018 (from 8 to 6.2 per 100 
women).\159\ These proposed rules would reduce unintended pregnancies 
and lead to better health outcomes for eligible individuals by 
increasing access to contraceptive services.
---------------------------------------------------------------------------

    \152\ Finer, L. & Zolna, M. (2016) ``Declines in Unintended 
Pregnancy in the United States, 2008-2011.'' N Engl J Med, 
374(9):843-52.
    \153\ Permanency Risk Assessment Monitoring System: Prevalence 
of Selected Maternal and Child Health Indicators for all Pregnancy 
Risk Assessment Monitoring System (PRAMS) Sites, 2016-2020. 
Available at: https://www.cdc.gov/prams/prams-data/mch-indicators/states/pdf/2020/All-Sites-PRAMS-MCH-Indicators-508.pdf.
    \154\ See FN 173.
    \155\ Monea, E., & Thomas, A. (2011). ``Unintended Pregnancy and 
Taxpayer Spending.'' Perspectives on Sexual & Reproductive Health, 
43(2), 88-93; and Sonfield, A. and Kost, K. (2013). ``Public Costs 
from Unintended Pregnancies and the Role of Public Insurance 
Programs in Paying for Pregnancy and Infant Care: Estimates for 
2008.'' Guttmacher Institute. Available at: https://www.guttmacher.org/pubs/public-costs-of-UP.pdf.
    Kaye, K., Gootman, J.A., Ng, A.S., & Finley, C. (2014). ``The 
Benefits of Birth Control in America: Getting the Facts Straight.'' 
The National Campaign to Prevent Teen and Unplanned Pregnancy. 
Available at: https://powertodecide.org/sites/default/files/resources/primary-download/benefits-of-birth-control-in-america.pdf.
    \156\ Sonfield, A. & Kost, K. (2013). ``Public Costs from 
Unintended Pregnancies and the Role of Public Insurance Programs in 
Paying for Pregnancy and Infant Care: Estimates for 2008.'' 
Guttmacher Institute. Available at: https://www.guttmacher.org/pubs/public-costs-of-UP.pdf.
    \157\ ``Preventing Unplanned Pregnancy.'' National Conference of 
State Legislatures (2021). Available at: https://www.ncsl.org/research/health/preventing-unplanned-pregnancy.aspx.
    \158\ Id.
    \159\ Dalton, V., Moniz, M., et al. (2020). ``Trends in Birth 
Rates After Elimination of Cost Sharing for Contraception by the 
Patient Protection and Affordable Care Act.'' JAMA Network Open, 
3(11): e2024398.
---------------------------------------------------------------------------

    Finally, these proposed rules would increase health equity, given 
the disproportionate burden of out-of-pocket spending on contraceptive 
services currently faced by low-income individuals (as those 
individuals with lower incomes must spend a greater percentage of their 
incomes on contraceptive services). As discussed earlier in this 
section, prior to the implementation of the ACA, out-of-pocket expenses 
for contraceptives represented a significant portion, estimated to 
range from 30 percent to 44 percent, of a woman's total out-of-pocket 
health care spending.\160\ A recent study found that people of color 
(and low-income people) are more likely to live in areas in which the 
proportion of reproductive-aged residents have a lack of, or difficulty 
obtaining, reproductive and contraceptive health care--referred to as 
``contraception deserts.'' \161\ The study found that the proportion of 
the population living within these types of areas ranges from 
approximately 17 percent in California to approximately 50 percent in 
Texas. One study has shown that in 2011, women with incomes below 100 
percent of the Federal poverty level had unplanned pregnancies at a 
rate seven times higher than those at or above 200 percent of the 
Federal poverty level. Unplanned pregnancies were also more common in 
women who have low incomes or are racial or ethnic minorities.\162\
---------------------------------------------------------------------------

    \160\ Becker, N., & Polsky, D. (2015). ``Women Saw Large 
Decrease in Out-Of-Pocket Spending for Contraceptives After ACA 
Mandate Removed Cost Sharing.'' Health Affairs; 34(7): 1204-1211.
    \161\ Kreitzer, R.J., Watts Smith, C., et al. (2021). 
``Affordable but Inaccessible? Contraception Deserts in the US 
States.'' Journal of Health Politics, Policy and Law 46(2): 277-304.
    \162\ 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.
---------------------------------------------------------------------------

    The enactment of the ACA has been shown to provide gains in 
coverage and access to women's reproductive health services and 
accompanying reduced costs for women who would otherwise be without 
health coverage or face large out-of-pocket costs. As noted in a recent 
study, even in some cases where ``medical insurance is available among 
women in the same socioeconomic strata, unexplained disparities persist 
and suggest that racism and other social and clinician-level issues are 
factors'' that can still result in unequal access to health care and 
distrust of physicians.\163\ Although it is believed that these 
proposed rules would have marginal effects on the overall level of 
health inequity, the presence of barriers to contraceptive coverage 
would be more burdensome on insured women with lower incomes and 
reducing those barriers could have the potential to reduce 
socioeconomic, racial, and ethnic disparities in health outcomes.\164\
---------------------------------------------------------------------------

    \163\ Sutton, M.Y., Anachebe, F., et al. (2021) Racial and 
Ethnic Disparities in Reproductive Health Services and Outcomes, 
2020. Obstetrics & Gynecology: 137(2): 225-233.
    \164\ Behn, M., Pace, L.E., et al. (2019). The Trump 
Administration's Final Regulations Limit Insurance Coverage of 
Contraception. Women's Health Issues, 29(2): 103-106.
---------------------------------------------------------------------------

Costs
    Participating providers of contraceptive services and issuers would 
need to enter into signed agreements for reimbursement of costs 
associated with the provision of contraceptive services to eligible 
individuals and would therefore incur related administrative costs. In 
order to estimate these costs, providers of contraceptive services have 
been divided into two broad categories--clinicians or facilities, and 
pharmacies. For each signed agreement between clinicians or facilities 
and issuers, the Departments estimate that, on average, senior managers 
would spend 4 hours (at $110.82 per hour \165\), lawyers would spend 40 
hours (at $142.34 per hour), legal secretaries would spend 40 hours (at 
$50.52 per hour), a clinician would spend 1 hour (at $284.82 per hour), 
and a chief executive officer would spend 15 minutes (at $204.82 per 
hour). The total burden for each signed agreement would be 85.25 hours, 
with an associated cost of approximately $8,494. There would be an 
estimated 1,090 signed agreements between 1,090 participating 
clinicians or facilities and issuers. The total estimated cost for all 
signed agreements between clinicians or facilities and issuers would be 
approximately $9.3 million. The number of signed agreements and related 
costs could be lower if multiple facilities are owned by the same 
entity. For each signed agreement between pharmacy chains and issuers, 
the Departments estimate that senior managers would spend 4 hours (at 
$110.82 per hour), lawyers would spend 40 hours (at $142.34 per hour), 
legal

[[Page 7263]]

secretaries would spend 40 hours (at $50.52 per hour), and chief 
executive officers would spend 30 minutes (at $204.82 per hour). The 
total burden for each signed agreement would be 84.5 hours, with an 
associated cost of approximately $8,260. There would be an estimated 10 
signed agreements between 10 participating pharmacy chains and issuers. 
The total estimated cost for all signed agreements between pharmacy 
chains and issuers would be approximately $82,601.
---------------------------------------------------------------------------

    \165\ The Departments generally used data from the Bureau of 
Labor Statistics to derive average labor costs (including a 100 
percent increase for fringe benefits and other indirect costs). May 
2021 Bureau of Labor Statistics, Occupational Employment Statistics, 
National Occupational Employment and Wage Estimates, available from 
https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------

    The total cost of 1,100 signed agreements between all providers of 
contraceptive services and issuers would be approximately $9.3 million 
in the first year. The Departments assume that half of these costs 
would be incurred by participating providers of contraceptive services 
and half by issuers (approximately $4.7 million each). Providers of 
contraceptive services are likely to incorporate these costs into their 
fees for providing the contraceptive services, while costs to issuers 
would be offset by Federal payments in the form of user fee 
adjustments. The annual costs of renegotiating and signing agreements 
in future years might be lower, unless providers of contraceptive 
services enter into new agreements with different issuers. The 
Departments seek comment on the number of signed agreements that would 
be executed annually and the magnitude of the potential administrative 
costs to providers of contraceptive services and issuers.

                               Table 2--Annual Costs Related to Signed Agreements
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                                                     number of    Estimated cost       Total
                            Entities                                  signed        per signed    estimated cost
                                                                    agreements       agreement
----------------------------------------------------------------------------------------------------------------
Clinicians/Facilities and Issuers...............................           1,090          $8,494      $9,258,138
Pharmacies and Issuers..........................................              10           8,260          82,601
                                                                 -----------------------------------------------
    Total.......................................................           1,100  ..............       9,340,739
----------------------------------------------------------------------------------------------------------------

    Participating providers of contraceptive services would also incur 
administrative costs related to eligibility verification, submission of 
claims, and document retention. These costs are estimated to be 
approximately $14.5 million annually and are discussed in detail later 
in the HHS Paperwork Reduction Act section, section VI.D of this 
preamble.
    Participating issuers would also incur administrative costs related 
to processing of amounts received from participating providers of 
contraceptive services, and submission of required information to HHS. 
As mentioned previously in this preamble, HHS proposes to reimburse 
participating issuers an administrative allowance of 15 percent for 
administrative costs and margin. Therefore, the estimated 
administrative costs and margin to issuers would be approximately $10.4 
million,\166\ which would be offset by Federal payments in the form of 
user fee adjustments. This total includes the estimated approximately 
$11,866 in costs related to the submission of required information to 
HHS as detailed later in the HHS Paperwork Reduction Act section, 
section VI.D of this preamble, and approximately $4.7 million in costs 
related to signing agreements discussed earlier in this section.
---------------------------------------------------------------------------

    \166\ Estimated total amount = cost of contraceptive services 
($49.9 million) + administrative costs to providers of contraceptive 
services (= $14.5 million + $4.7 million) = $69 million. 15 percent 
of $69 million = $10.4 million approximately.
---------------------------------------------------------------------------

    Individuals would incur costs associated with finding providers of 
contraceptive services that would be willing to participate in the 
individual contraceptive arrangement. Some individuals might have to 
switch providers of contraceptive services if their usual providers of 
contraceptive services are not willing to participate in the individual 
contraceptive arrangement. The Departments seek comment on ways to 
mitigate search costs for eligible individuals and how access to the 
individual contraceptive arrangement can best be promoted. One option 
could be to make a list of participating providers publicly available 
on a public website. The Departments also seek comment on whether 
making provider information publicly available might deter provider 
participation in the individual contraceptive arrangement. 
Additionally, as discussed previously, people of color and low-income 
people are more likely to live in areas considered contraception 
deserts. If eligible individuals live in contraception deserts, they 
might have to spend more time and money traveling longer distances in 
order to meet with a participating provider of contraceptive services. 
The Departments seek comment on the number of eligible individuals 
without access to contraceptive services without cost sharing under 
their existing plan or coverage or living in contraception deserts and 
the potential search costs of these proposed rules on such individuals.
    There would also be a reduction in health care costs for 
individuals who gain access to contraceptive services and for group 
health plans and coverage sponsored, arranged, or provided by exempt 
entities if these proposed rules lead to a reduction in unintended 
pregnancies or improved health outcomes.
    Individuals who do not currently have contraceptive coverage 
through group health plans and coverage sponsored by exempt entities 
may turn to State-funded programs to obtain contraceptive services. 
States may also currently incur costs related to unintended pregnancies 
resulting from a lack of access to contraceptive services for these 
individuals. These proposed rules may therefore lead to cost savings 
for states, to the extent that states are currently incurring costs to 
provide or fund contraceptive services or birth and maternity care for 
individuals who would gain access to contraceptive services as a result 
of these proposed rules. The Departments seek comment on the potential 
impacts of these proposed rules on states and State finances.
Transfers
    These proposed rules would result in a transfer from the Federal 
Government, via the provision of user fee adjustments to issuers that 
would then reimburse providers of contraceptive services for the costs 
of furnishing contraceptive services, to individuals who would now have 
access to contraceptive services without cost sharing and no longer 
incur out-of-pocket spending on contraceptive services. As discussed 
previously in the Number of Affected Entities discussion of this 
section, it is estimated that at least 126,400

[[Page 7264]]

individuals would be eligible to participate in the individual 
contraceptive arrangement. Based on the limited information available 
from the 2019 user fee adjustment data,\167\ the Departments estimate 
that the average annual cost of contraceptive services for one 
individual is approximately $395. Therefore, the Departments estimate 
that the provision of the individual contraceptive arrangement could 
lead to a transfer from the Federal Government to individuals (via 
issuers to providers of contraceptive services) of approximately $49.9 
million annually.\168\ This estimate is uncertain due to the limited 
information available in the 2019 user fee adjustment data, and the 
Departments seek comment on the estimated average annual cost of 
contraceptive services per individual. Assuming these proposed 
regulations are finalized and become applicable during 2023, transfers 
might be lower in 2023, since 2023 transfers would include services 
furnished during only part of the year.
---------------------------------------------------------------------------

    \167\ HHS used 2019 data for this estimate to better reflect 
claims experience outside of the COVID-19 public health emergency.
    \168\ 126,400 x $395 = $49.9 million approximately.
---------------------------------------------------------------------------

    In addition, a reduction in unintended pregnancies or improved 
health outcomes could lead to a reduction in premiums.
    The Departments also expect that the proposed elimination of the 
exemption for entities and individuals that object to contraceptive 
coverage based on non-religious moral beliefs could lead to a transfer 
from plans and issuers to participants, beneficiaries, and enrollees 
due to reduced out-of-pocket spending on contraceptive services. 
However, the Departments do not have information on the number of 
entities and individuals that have claimed a moral exemption to 
providing contraceptive coverage and seek comment on the number of 
entities and individuals that would be affected by this proposed 
change.
Uncertainty
    Although the Departments expect that these proposed rules would 
expand access to contraceptive services without cost sharing, as noted 
earlier in this section, there are several areas of uncertainty 
regarding the potential impacts of these proposed rules.
    The Departments are uncertain how many providers of contraceptive 
services, issuers, and eligible individuals would participate in the 
individual contraceptive arrangement. The Departments seek comment on 
potential barriers that might prevent providers, issuers, and eligible 
individuals from participating in the individual contraceptive 
arrangement. The Departments anticipate that the administrative 
allowance--which would be expected to cover participating issuers' 
administrative costs and provide a margin to ensure that participating 
issuers receive appropriate compensation for providing reimbursements--
would incentivize issuers to participate in the individual 
contraceptive arrangement.
    The Departments expect that administrative costs incurred by 
participating providers of contraceptive services to deliver the 
services would be included in the amounts they submit to issuers for 
reimbursement (as noted earlier in this section), and therefore would 
not be a deterrent to participation in the individual contraceptive 
arrangement. The Departments are unable to estimate these costs 
precisely because these costs are expected to vary. These costs might 
be lower for larger providers, due to larger economies of scale, and 
for providers that might currently have contracts with participating 
issuers. The Departments are uncertain as to how the number of 
participating providers might vary (for example, across rural and urban 
areas) and how this variation might affect access to services under the 
individual contraceptive arrangement.
    Due to the lack of data, the Departments are unable to develop a 
precise estimate of the number of eligible individuals who might 
participate in the individual contraceptive arrangement because the 
Departments do not know how many entities have claimed an exemption 
under the November 2018 Religious Exemption final rules. Further, take-
up of the individual contraceptive arrangement by eligible individuals 
would be affected by, among other things, awareness of the individual 
contraceptive arrangement, the number of providers of contraceptive 
services that participate in the individual contraceptive arrangement, 
and the amount of time and effort it would take an individual to find a 
participating provider.
    The Departments are unable to develop a more accurate estimate of 
the transfers and cost to the Federal Government (discussed earlier in 
this section) as there is uncertainty regarding the total amounts for 
contraceptive services that would be submitted by providers of 
contraceptive services to issuers for reimbursement, and therefore the 
total amount of the transfer from the Federal Government to eligible 
individuals, and the total amounts of the administrative costs incurred 
by participating providers and issuers. Finally, this overall lack of 
data leads to uncertainty regarding the magnitudes of the total cost 
savings to eligible individuals and any resulting potential cost 
savings to states (associated with reduced spending on State-funded 
programs that provide contraceptive services or a potential reduction 
in the number of unintended pregnancies that would otherwise impose 
costs to states).
    The Departments seek comment on all of these areas of uncertainty 
regarding the impacts of these proposed rules.

C. Regulatory Alternatives

    In developing these proposed rules, the Departments considered 
various alternative approaches.
    The Departments considered maintaining the exemption (along with 
the existing accommodations and the proposed individual contraceptive 
arrangement) with respect to group health plans, health insurance 
issuers, and institutions of higher education that have a non-religious 
moral objection to contraceptive coverage. The Departments, however, 
are of the view that neither RFRA nor any other Federal statute compels 
such an exemption, and propose eliminating this exemption for several 
reasons, especially given the strong public interest in assuring 
contraceptive coverage to women enrolled in group health plans, or 
group or individual (including student) health insurance coverage.
    With respect to individuals enrolled in coverage through entities 
that have a religious objection to contraceptive coverage, the 
Departments considered an approach under which contraceptive coverage 
would be available through separate individual insurance policies that 
cover only contraceptives and in which participants, beneficiaries, and 
enrollees would have to separately enroll if they desired contraceptive 
coverage. Because separate contraception-only coverage would not comply 
with the individual market reforms, it would be necessary for the 
Departments to create, by regulation, a new excepted benefit category 
for individual contraceptive-only coverage.\169\ Under this approach, 
issuers of this coverage would receive FFE or SBE-FP user fee 
reductions to pay for this coverage, as the issuer generally would not 
realize offsetting savings in pregnancy-related costs when providing 
coverage separate from the plan or coverage offered by the objecting 
entity. If the issuer of this coverage did not participate in the FFE 
or an SBE-FP,

[[Page 7265]]

it could partner with an FFE or SBE-FP issuer to receive the user fee 
adjustment.
---------------------------------------------------------------------------

    \169\ See, for example, section 2791(c)(2)(C) of the PHS Act.
---------------------------------------------------------------------------

    The Departments decided against this option for a number of 
reasons. The Departments are concerned that issuers would not offer 
these products to a sufficient extent to ensure access nationwide, as 
commenters on the July 2016 RFI explained that it would be costly and 
administratively burdensome for issuers to develop and implement new 
eligibility, enrollment, and claims-adjudication systems for 
contraception-only coverage, as they would differ from their existing 
systems. Additionally, some State regulators might not have authority 
or capacity to approve single-benefit insurance policies (other than 
dental or vision or disease-specific excepted benefits policies) within 
a relatively short period of time after Federal rules would permit 
these policies. Cost-free contraception policies would also not satisfy 
some State laws conditioning policy approval on a ``reasonable 
premium'' or the existence of valid contracts because the prospective 
policyholder would not provide consideration in exchange for the 
coverage.
    The Departments also considered an approach under which, if an 
objecting entity designs or contracts for a health plan without 
contraceptive coverage, the contraceptive coverage requirement would 
apply directly to the issuer, in the case of a fully insured plan (that 
is, the issuer would not be exempted from the requirement on the basis 
of the objecting entity's objection), or the third party administrator, 
in the case of a self-insured plan. The issuer or third party 
administrator would then be required to fulfill its separate and 
independent obligation to provide contraceptive coverage, in the same 
manner as it is required to do so with respect to a non-exempt entity. 
However, the Departments are of the view that there would not be legal 
authority for imposing this obligation on a third party administrator. 
With respect to issuers, the Departments decided to solicit comment on 
this approach, as further described in section II.C.1 of this preamble.
    With respect to the proposed changes to 45 CFR 156.50(d), in 
addition to the proposed submission requirements on the part of the 
participating issuer, HHS considered whether to condition a provider of 
contraceptive services' participation in the individual contraceptive 
arrangement for eligible individuals on the provider of contraceptive 
services' agreement to submit to HHS identifying information for itself 
and the participating issuer, the total dollar amount of the cost of 
furnishing contraceptive services pursuant to the individual 
contraceptive arrangement, and an attestation that the costs for 
furnishing such services were incurred in compliance with the 
requirements of the individual contraceptive arrangement. However, HHS 
is of the view that conditioning participation in the individual 
contraceptive arrangement on compliance with a separate submission 
requirement for providers of contraceptive services would create 
significant additional burden on providers of contraceptive services 
and could deter participation in the individual contraceptive 
arrangement, reducing access to contraceptive services for eligible 
individuals.
    In addition to an arrangement with a participating issuer on the 
FFE or an SBE-FP, HHS considered whether to allow a provider of 
contraceptive services to arrange with a third party administrator to 
submit documentation to HHS on their behalf under 45 CFR 156.50(d). 
Under this arrangement, a third party administrator entering into an 
agreement with a provider of contraceptive services would partner with 
an FFE or SBE-FP issuer to receive reimbursement for its costs of 
furnishing contraceptive services and then the third party 
administrator would pay the provider of contraceptive services. 
Establishing a direct contractual relationship between providers of 
contraceptive services and third party administrators was rejected as 
more administratively complex because providers and third party 
administrators do not have the same existing contractual agreements to 
deliver these services as providers and issuers do. In contrast, the 
proposed approach of direct agreements between providers of 
contraceptive services and participating issuers on the FFE or an SBE-
FP builds upon existing relationships between providers and issuers.

D. Paperwork Reduction Act--Department of Health and Human Services

    Under the Paperwork Reduction Act of 1995 (PRA), HHS is required to 
provide 60-days' notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
OMB for review and approval. To fairly evaluate whether an information 
collection should be approved by OMB, section 3506(c)(2)(A) of the PRA 
requires that HHS solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of the agency.
     The accuracy of HHS' estimate of the information 
collection burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
1. Wage Estimates
    HHS generally uses data from the Bureau of Labor Statistics to 
derive average labor costs (including a 100 percent increase for the 
cost of fringe benefits and other indirect costs) for estimating the 
burden associated with the information collection requirements 
(ICRs).\170\ Table 3 presents the mean hourly wage, the cost of fringe 
benefits and other indirect costs, and the adjusted hourly wage.
---------------------------------------------------------------------------

    \170\ See May 2021 Bureau of Labor Statistics, Occupational 
Employment Statistics, National Occupational Employment and Wage 
Estimates, available at https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------

    As indicated, employee hourly wage estimates have been adjusted by 
a factor of 100 percent. This is necessarily a rough adjustment, both 
because the cost of fringe benefits and other indirect costs vary 
significantly across employers, and because methods of estimating these 
costs vary widely across studies. Nonetheless, there is no practical 
alternative, and HHS is of the view that doubling the hourly wage to 
estimate total cost is a reasonably accurate estimation method.

[[Page 7266]]



                             Table 3--Adjusted Hourly Wages Used in Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                  Cost of fringe
                                                                    Mean hourly    benefits and      Adjusted
           Occupation title                 Occupational code      wage ($/hour)  other indirect  hourly wage ($/
                                                                                  costs ($/hour)       hour)
----------------------------------------------------------------------------------------------------------------
All Occupations.......................  00-0000.................          $28.01          $28.01          $56.02
Actuary...............................  15-2011.................           60.24           60.24          120.48
Insurance Claims and Policy Processing  43-9041.................           22.02           22.02           44.04
 Clerks.
Medical Secretaries and Administrative  43-6013.................           19.11           19.11           38.22
 Assistants.
----------------------------------------------------------------------------------------------------------------

2. ICRs Regarding Adjustment of Exchange User Fees--Participating 
Issuers (45 CFR 156.50(d)(2))
    The proposed provisions would require a participating issuer on the 
FFE or an SBE-FP seeking a user fee adjustment to submit to HHS, in the 
year following the calendar year in which the contraceptive services 
for which reimbursement pursuant to the proposed individual 
contraceptive arrangement were furnished, the following: (A) 
identifying information for the participating issuer and each provider 
of contraceptive services with respect to which the participating 
issuer seeks an adjustment of any user fee; (B) documentation, with 
respect to each provider of contraceptive services, demonstrating that 
the participating issuer and provider of contraceptive services have 
agreed that the participating issuer will seek an adjustment of the 
user fee to reimburse the provider of contraceptive services for the 
costs of furnishing contraceptive services; and (C) for each provider 
of contraceptive services, the total dollar amount of the costs of the 
contraceptive services that were furnished during the applicable 
calendar year pursuant to the proposed individual contraceptive 
arrangement. The proposed amendments also require that a participating 
issuer on the FFE or an SBE-FP receiving an adjustment to any user fee 
under 45 CFR 156.50(d) for a particular calendar year must maintain 
documentation for 10 years demonstrating that it timely paid each 
provider of contraceptive services, with respect to which it received 
such adjustment, any amount required under paragraph 45 CFR 
156.50(d)(5).
    Approximately 40 QHP issuers have entered into arrangements with 
third party administrators under the third party administrator optional 
accommodation.\171\ HHS anticipates that all (or some subset) of those 
issuers that have already entered into arrangements with third party 
administrators would be most likely to enter into arrangements with 
providers of contraceptive services because they would already be 
familiar with the process for seeking a user fee adjustment related to 
payments for contraceptive services. HHS anticipates there would be an 
increase in burden associated with these proposed data submission 
requirements for those issuers that participate in the individual 
contraceptive arrangement.
---------------------------------------------------------------------------

    \171\ See 78 FR 39870 at 39875 through 39886 for additional 
background on the third party administrator optional accommodation.
---------------------------------------------------------------------------

    HHS would collect the required data elements for participating 
issuers on the FFE or an SBE-FP to receive a user fee adjustment under 
the proposed individual contraceptive arrangement through the same web 
form online tool and at the same time as participating issuers complete 
the data submission process for the third party administrator optional 
accommodation. HHS previously estimated that for the issuers that enter 
into arrangements with third party administrators, each issuer needs 
approximately 3 hours of actuarial work, 5 hours of work by claims and 
policy processing clerks, 2 hours for legal counsel, and 1 hour for a 
top executive.\172\ For issuers that would participate in arrangements 
with providers of contraceptive services, HHS estimates that each 
issuer would incur an additional burden of 1 hour of work by an actuary 
(at $120.48 per hour), and 4 hours of work by claims and policy 
processing clerks (at $44.04 per hour) including time for 
recordkeeping. The total additional burden for each issuer would be 5 
hours annually, with an equivalent cost of approximately $297. 
Therefore, if all 40 issuers enter into arrangements with providers of 
contraceptive services, the total annual burden associated with this 
requirement would be approximately 200 hours, at a cost of 
approximately $11,866. These costs would be offset by Federal payments 
in the form of user fee adjustments.
---------------------------------------------------------------------------

    \172\ This burden is currently approved under OMB control number 
0938-1285 (CMS-10492, Coverage of Certain Preventive Services Under 
the Affordable Care Act: Data Submission Requirements to Receive the 
Federally-facilitated Exchange User Fee Adjustment).

                                               Table 4--Annual Burden and Costs for Participating Issuers
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Estimated number of            Estimated number of       Estimated burden per response
         respondents                     responses                        (hours)             Total annual burden  (hours)      Total estimated cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                        40                             40                              5                            200                       $11,866
--------------------------------------------------------------------------------------------------------------------------------------------------------

    HHS will revise the information collection currently approved under 
OMB control number 0938-1285 (CMS-10492), to account for this new 
burden.
3. ICRs Regarding Adjustment of Exchange User Fees--Participating 
Providers of Contraceptive Services (45 CFR 156.50(d)(8))
    The proposed provisions require that, as a condition of 
participation in the proposed individual contraceptive arrangement, 
providers of contraceptive services would be required to maintain 
documentation for 10 years demonstrating that the costs of furnishing 
contraceptive services were

[[Page 7267]]

made in compliance with the individual contraceptive arrangement, 
including a representation by (or on behalf of) the individual 
demonstrating the individual's eligibility for the individual 
contraceptive arrangement, and the total dollar amount of the costs of 
the contraceptive services furnished. As discussed previously in 
section VI.B.2 of this preamble, HHS estimates that at least 2,180 
providers of contraceptive services (1,090 pharmacies, and 1,090 
clinicians and facilities), and 126,400 individuals would participate 
in the individual contraceptive arrangement. Eligible individuals could 
receive contraceptive services from more than one provider of 
contraceptive services (1,090 pharmacies, and 1,090 clinicians or 
facilities). HHS anticipates that eligible individuals would likely 
receive contraceptive services from more than one provider of 
contraceptive services (for example, during a visit to a clinician or 
facility and during a visit to a pharmacy to fill a prescription) and 
more than once a year. HHS therefore estimates that each provider of 
contraceptive services would furnish contraceptive services to 
approximately 116 eligible individuals annually, on average.
    HHS assumes that a provider of contraceptive services (for example, 
clinician, facility, or pharmacy) would confirm eligibility for each 
individual only once annually and submit all claims for all eligible 
individuals together to the issuer. HHS estimates that for each 
provider of contraceptive services, a medical secretary would need, on 
average, approximately 1.5 hours (at $38.22 per hour) to record each 
representation demonstrating an individual's eligibility for the 
individual contraceptive arrangement, calculate and record the costs 
associated with the contraceptive services furnished throughout the 
year, submit the amounts to the participating issuer on the FFE or an 
SBE-FP, and maintain records. The total burden for each provider of 
contraceptive services would be, on average, 1.5 hours for each 
individual, with an associated cost of $57.33. For 2,180 providers of 
contraceptive services, the total burden related to furnishing 
contraceptive services to 126,400 individuals (assuming each individual 
receives contraceptive services from 2 providers on average each year) 
would be 379,200 hours with an associated cost of approximately $14.5 
million. These estimates constitute the lower bound, as burden and 
costs would be higher if the number of eligible individuals is higher, 
or if eligible individuals see more than two providers of contraceptive 
services in a year. Providers of contraceptive services would be likely 
to incorporate these costs into their fees for providing the 
contraceptive services.

             Table 5--Annual Burden and Costs for Participating Providers of Contraceptive Services
----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
                                     Estimated       Estimated      burden per     Total annual        Total
    Provider or facility type        number of       number of       response     burden (hours)  estimated cost
                                    respondents      responses        (hours)
----------------------------------------------------------------------------------------------------------------
Clinicians or Facilities........           1,090         126,400             1.5         189,600      $7,246,512
Pharmacies......................           1,090         126,400             1.5         189,600       7,246,512
                                 -------------------------------------------------------------------------------
    Total.......................           2,180         252,800             1.5         379,200      14,493,024
----------------------------------------------------------------------------------------------------------------

    HHS will revise the information collection currently approved under 
OMB control number 0938-1285 (CMS-10492), to account for this new 
burden.
4. ICRs Regarding Confirmation of Eligibility for the Individual 
Contraceptive Arrangement (45 CFR 147.131(a)(3)(ii))
    Individuals could confirm their eligibility for the individual 
contraceptive arrangement with a provider of contraceptive services by 
providing a summary of benefits that includes the relevant information 
provided under the plan, or by providing an attestation. These proposed 
rules include, in 45 CFR 147.131(d)(2), an example of language that 
could be used by participants, beneficiaries and enrollees or their 
authorized representatives to confirm eligibility. The Departments 
estimate that at least 126,400 individuals would be eligible for the 
individual contraceptive arrangement and would need to confirm their 
eligibility, and that each eligible individual would need, on average, 
5 minutes (at an equivalent cost of $56.02 per hour) to do so. The 
total burden for all individuals to confirm their eligibility for the 
individual contraceptive arrangement to their provider of contraceptive 
services would be approximately 10,533 hours with an equivalent cost of 
approximately $590,077. The Departments consider these estimates to be 
a lower bound, as the total burden and costs would be higher if the 
number of eligible individuals that take part in the individual 
contraceptive arrangement is higher. As HHS, DOL, and the Department of 
the Treasury share jurisdiction, HHS would account for 50 percent of 
the burden, or approximately 5,267 hours annually, with an equivalent 
annual cost of $295,039. DOL and the Department of the Treasury would 
each account for 25 percent of the burden, as discussed in section VI.E 
of this preamble.

                                                    Table 6--Annual Burden and Costs for Individuals
--------------------------------------------------------------------------------------------------------------------------------------------------------
     Estimated number of            Estimated number of           Estimated burden  per
         respondents                     responses                   response (hours)         Total annual burden (hours)       Total estimated cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                    63,200                         63,200                           0.08                          5,267                      $295,039
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 7268]]

    HHS will revise the information collection currently approved under 
OMB control number 0938-1344 (CMS-10653),\173\ to account for this new 
burden.
---------------------------------------------------------------------------

    \173\ OMB Control Number: 0938-1344 (CMS-10653, Coverage of 
Certain Preventive Services Under the Affordable Care Act).
---------------------------------------------------------------------------

5. ICRs Regarding the Existing Optional Accommodation for Exempt 
Entities (45 CFR 147.131(b))
    An entity seeking to be treated as an eligible organization for the 
existing optional accommodation may self-certify (by using EBSA Form 
700), prior to the beginning of the first plan year to which an 
accommodation is to apply, that it meets the definition of an eligible 
organization. An eligible organization may submit a notification to HHS 
as an alternative to submitting the EBSA Form 700 to the eligible 
organization's health insurance issuer or third party administrator.
    The burden related to this optional accommodation is currently 
approved under OMB Control Number: 0938-1344 (CMS-10653). HHS will 
revise this information collection to update the EBSA Form 700 and 
model notice to HHS to reflect the proposal to remove the moral 
exemption. However, the burden estimates would not be affected by the 
provisions in these proposed rules as the Departments did not 
previously expect any entities with non-religious moral objections to 
use the existing optional accommodation.
6. ICRs Regarding Notice of Availability of Separate Payments for 
Contraceptive Services (45 CFR 147.131(c))
    A health insurance issuer or third party administrator providing or 
arranging separate payments for services for participants and 
beneficiaries in insured plans (or student enrollees and covered 
dependents in student health insurance coverage) of eligible 
organizations exercising the existing optional accommodation is 
required to provide a written notice to the plan participants and 
beneficiaries (or student enrollees and covered dependents) informing 
them of the availability of these payments. As discussed previously in 
section II.D.1 of this preamble, the Departments propose to amend the 
model language for this notice. The burden related to this notice is 
currently approved under OMB Control Number: 0938-1344 (CMS-10653). HHS 
will revise this information collection to update the model notice to 
reflect this proposed amendment. The Departments previously estimated 
that 109 respondents will incur an annual burden of 136.25 hours with 
an equivalent cost of approximately $7,000, and materials and mailing 
cost of approximately $358,000 annually to comply with this ICR. The 
burden and cost estimates would not be affected by the proposed change 
in model language for the notice.
7. Summary of Annual Burden Estimates for Proposed Information 
Collection Requirements

                                                Table 7--Annual Recordkeeping and Reporting Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                        Average
                                                                                              Burden per     Total      hourly       Total
          Regulation section                OMB  control No.        Respondents    Responses    response    annual       labor       labor    Total cost
                                                                                                (hours)     burden      cost of     cost of
                                                                                                            (hours)    reporting   reporting
--------------------------------------------------------------------------------------------------------------------------------------------------------
45 CFR Sec.   156.50(d)(2)............  0938-1285...............              40          40           5         200      $59.33     $11,866     $11,866
45 CFR Sec.   156.50(d)(8)............  0938-1285...............           2,180     252,800         1.5     379,200       38.22  14,493,024  14,493,024
45 CFR Sec.   147.131(a)(3)(ii).......  0938-1285...............          63,200      63,200        0.08       5,267       56.02     295,039     295,039
                                                                 ---------------------------------------------------------------------------------------
    Total.............................  ........................          65,420      63,200  ..........     384,667  ..........  14,799,928  14,799,928
--------------------------------------------------------------------------------------------------------------------------------------------------------

8. Submission of PRA-Related Comments
    HHS has submitted a copy of these proposed rules to OMB for its 
review of the rule's information collection and recordkeeping 
requirements. These requirements are not effective until they have been 
approved by the OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections, please visit CMS's website at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing. HHS invites public comments on 
these potential information collection requirements. If you wish to 
comment, please submit your comments electronically as specified in the 
ADDRESSES section of these proposed rules and identify the rule (CMS-
9903-P), the ICR's CFR citation, CMS ID number, and OMB control number.
    ICR-related comments are due April 3, 2023.

E. Paperwork Reduction Act--Department of Labor and Department of the 
Treasury

    As part of their continuing effort to reduce paperwork and 
respondent burden, the Department of Labor and the Department of the 
Treasury conduct a preclearance consultation program to allow the 
general public and Federal agencies to comment on proposed and 
continuing collections of information in accordance with the PRA.\174\ 
This helps to ensure that the public understands the Departments' 
collection instructions, respondents can provide the requested data in 
the desired format, reporting burden (time and financial resources) is 
minimized, collection instruments are clearly understood, and the 
Departments can properly assess the impact of collection requirements 
on respondents.
---------------------------------------------------------------------------

    \174\ 44 U.S.C. 3506(c)(2)(A) (1995).
---------------------------------------------------------------------------

    Currently, the Department of Labor and the Department of the 
Treasury are soliciting comments concerning the proposed information 
collection request (ICR) included in the Coverage of Certain Preventive 
Services under the Affordable Care Act--Private Sector. To obtain a 
copy of the ICR, contact the PRA addressee shown below or go to https://www.RegInfo.gov.
    The Departments have submitted a copy of these proposed rule to OMB 
in accordance with 44 U.S.C. 3507(d) for review of its information 
collections. The Departments and OMB are particularly interested in 
comments that:
     Evaluate whether the collection of information is 
necessary for the functions of the agency, including whether the 
information will have practical utility;

[[Page 7269]]

     Evaluate the accuracy of the agency's estimate of the 
burden of the collection of information, including the validity of the 
methodology and assumptions used;
     Enhance the quality, utility, and clarity of the 
information to be collected and minimize the burden of the collection 
of information on those who are to respond, including through the use 
of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology (for example, permitting electronically delivered 
responses).
    Commenters may send their views on the Departments' PRA analysis in 
the same way they send comments in response to the proposed rule as a 
whole (for example, through the www.regulations.gov website), including 
as part of a comment responding to the broader proposed rule. Comments 
are due by April 3, 2023 to ensure their consideration.
    PRA Addressee: Address requests for copies of the ICR to James 
Butikofer, Office of Research and Analysis, U.S. Department of Labor, 
Employee Benefits Security Administration, 200 Constitution Avenue NW, 
Room N-5718, Washington, DC 20210; or send to [email protected].
1. ICRs Regarding Confirmation of Eligibility for the Individual 
Contraceptive Arrangement (26 CFR 54.9815-2713A(a)(3)(iii), 29 CFR 
2590.715-2713A(a)(3)(iii))
    Individuals could confirm their eligibility for the individual 
contraceptive arrangement with a provider of contraceptive services by 
providing a summary of benefits that includes the relevant information 
provided under the plan, or by providing an attestation. The 
Departments propose, in 26 CFR 54.9815-2713A(a)(3)(iii) and 29 CFR 
2590.715-2713A(a)(3)(iii), an example of language that could be used by 
participants, beneficiaries, and enrollees or their authorized 
representatives to confirm eligibility. The Departments estimate that 
at least 126,400 individuals would be eligible for the individual 
contraceptive arrangement and would need to confirm their eligibility, 
and that each eligible individual would need, on average, 5 minutes (at 
an equivalent cost of $68.96 per hour) to do so. The total burden for 
all individuals to confirm their eligibility for the individual 
contraceptive arrangement to their provider of contraceptive services 
would be approximately 10,533 hours with an equivalent cost of 
approximately $726,356. The Departments consider these estimates to be 
a lower bound, as the total burden and costs would be higher if the 
number of eligible individuals that take part in the individual 
contraceptive arrangement is higher. As HHS, DOL, and the Department of 
the Treasury share jurisdiction, HHS would account for 50 percent of 
the burden, as discussed in section VI.D of this preamble and DOL and 
the Department of the Treasury would each account for 25 percent of the 
burden, or approximately 2,633 hours annually with an equivalent annual 
cost of $181,572.
    The burden related to the confirmation of eligibility for the 
individual contraceptive arrangement will be included under OMB Control 
Number: 1210-0150 (Coverage of Certain Preventive Services under the 
Affordable Care Act--Private Sector). The information collection has a 
current expiration date of November 30, 2024.
2. ICRs Regarding the Existing Optional Accommodation for Exempt 
Entities (26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A)
    An entity seeking to be treated as an eligible organization for the 
existing optional accommodation may self-certify (by using EBSA Form 
700), prior to the beginning of the first plan year to which an 
accommodation is to apply, that it meets the definition of an eligible 
organization. An eligible organization may submit a notification to HHS 
as an alternative to submitting the EBSA Form 700 to the eligible 
organization's health insurance issuer or third party administrator.
    The burden related to this optional accommodation is currently 
approved under OMB Control Number: 1210-0150 (Coverage of Certain 
Preventive Services under the Affordable Care Act--Private Sector). The 
Departments will revise this information collection to update the EBSA 
Form 700 and model notice to HHS to reflect the proposal to remove the 
moral exemption. However, the burden estimates would not be affected by 
the provisions in these proposed rules, as the Departments did not 
previously expect entities with non-religious moral objections to use 
the existing optional accommodation. The information collection has a 
current expiration date of November 30, 2024.
3. ICRs Regarding Notice of Availability of Separate Payments for 
Contraceptive Services (26 CFR 54.9815-2713A, 29 CFR 2590.715-2713A)
    A health insurance issuer or third party administrator providing or 
arranging separate payments for contraceptive services for participants 
and beneficiaries in insured plans (or student enrollees and covered 
dependents in student health insurance coverage) of eligible 
organizations exercising the existing optional accommodation is 
required to provide a written notice to such plan participants and 
beneficiaries (or such student enrollees and covered dependents) 
informing them of the availability of such payments. The Departments 
propose to amend the model language for this notice. The burden related 
to this notice is currently approved under OMB Control Number: 1210-
0150 (Coverage of Certain Preventive Services under the Affordable Care 
Act--Private Sector). The Departments will revise this information 
collection to update the model notice to reflect this proposed 
amendment. The Departments previously estimated that 109 respondents 
will incur an annual burden of 136.25 hours with an equivalent cost of 
approximately $7,000, and materials and mailing cost of approximately 
$358,000 annually to comply with this ICR. The burden and cost 
estimates would not be affected by the proposed change in model 
language for the notice. The information collection has a current 
expiration date of November 30, 2024.
4. Summary of Annual Burden Estimates for Proposed Information 
Collection Requirements
    A summary of paperwork burden estimates follows:
    Type of Review: Revision.
    Agency: Employees Benefits Security Administration, U.S. Department 
of Labor.
    Title: Coverage of Certain Preventive Services under the Affordable 
Care Act--Private Sector.
    OMB Control Number: 1210-0150.
    Affected Public: Individuals and households, Businesses or other 
for-profits, Not-for-profit institutions.
    Estimated Number of Respondents: 31,630.
    Estimated Number of Annual Responses: 329,255.
    Frequency of Response: Annual.
    Estimated Total Annual Burden Hours: 2,669.
    Estimated Total Annual Burden Cost: $80,873.
    Agency: Internal Revenue Service, Department of the Treasury.
    Title: Coverage of Certain Preventive Services under the Affordable 
Care Act--Private Sector.
    OMB Control Number: 1545-NEW.
    Affected Public: Individuals and households, Businesses or other 
for-profits, Not-for-profit institutions.

[[Page 7270]]

    Estimated Number of Respondents: 31,630.
    Estimated Number of Annual Responses: 329,255.
    Frequency of Response: Annual.
    Estimated Total Annual Burden Hours: 2,669.
    Estimated Total Annual Burden Cost: $80,873.

F. Regulatory Flexibility Act

    The Regulatory Flexibility Act, (5 U.S.C. 601, et seq.), requires 
agencies to prepare an initial regulatory flexibility analysis to 
describe the impact of proposed rules on small entities, unless the 
head of the agency can certify that the rules will not have a 
significant economic impact on a substantial number of small entities. 
The RFA generally defines a ``small entity'' as (1) a proprietary firm 
meeting the size standards of the Small Business Administration (SBA), 
(2) a not-for-profit organization that is not dominant in its field, or 
(3) a small government jurisdiction with a population of less than 
50,000. States and individuals are not included in the definition of 
``small entity.'' The Departments use a change in revenues of more than 
3 to 5 percent as its measure of significant economic impact on a 
substantial number of small entities.
    The provisions in these proposed rules would affect health 
insurance issuers and providers that furnish contraceptive services 
(including clinicians, facilities, and pharmacies). Health insurance 
issuers would be classified under the North American Industry 
Classification System (NAICS) code 524114 (Direct Health and Medical 
Insurance Carriers). According to SBA size standards,\175\ entities 
with average annual receipts of $41.5 million or less are considered 
small entities for this NAICS code. Issuers could possibly be 
classified in 621491 (HMO Medical Centers) and, if this is the case, 
the SBA size standard would be $39 million or less. The Departments 
expect that few, if any, insurance companies underwriting comprehensive 
health insurance policies (in contrast, for example, to travel 
insurance policies or dental discount policies) fall below these size 
thresholds. Based on data from medical loss ratio (MLR) annual report 
\176\ submissions for the 2020 MLR reporting year, approximately 78 out 
of 481 issuers of health insurance coverage nationwide had total 
premium revenue of $41.5 million or less. This estimate may overstate 
the actual number of small health insurance companies that may be 
affected, since over 72 percent of these small companies belong to 
larger holding groups, and many, if not all, of these small companies 
are likely to have non-health lines of business that will result in 
their revenues exceeding $41.5 million. In addition, costs incurred by 
issuers would be offset by Federal payments in the form of user fee 
adjustments.
---------------------------------------------------------------------------

    \175\ https://www.sba.gov/document/support--table-size-standards, as of October 2022.
    \176\ Available at https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.html.
---------------------------------------------------------------------------

    Clinicians and facilities would be classified under either NAICS 
code 621111 (Offices of Physicians) with a size standard of $14 million 
or less or NAICS code 621399 (Offices of All Other Miscellaneous Health 
Practitioners) with a size standard of $9 million or less. Facilities 
could also be classified under NAICS code 621410 (Family Planning 
Centers), with a size standard of $16.5 million or less. The 
Departments estimate that approximately 1,090 clinicians and facilities 
would participate in the individual contraceptive arrangement and would 
incur costs related to signing agreements with participating issuers, 
eligibility verification, and recordkeeping. Most, if not all, 
participating clinicians and facilities might be considered small 
entities. As discussed earlier in section VI.D of this preamble, these 
costs per clinician or facility are estimated to be approximately 
$10,895 annually \177\ and would likely be accounted for in amounts 
submitted to participating issuers for reimbursement by the Federal 
Government. The Departments assume that clinicians or facilities would 
not participate in the individual contraceptive arrangement if it 
results in a decline in their revenues or profitability.
---------------------------------------------------------------------------

    \177\ Total administrative costs for 1,090 clinicians and 
facilities = $4,629,069 in administrative costs for signed 
agreements + $7,246,512 in administrative costs related to providing 
contraceptive services = $11,875,581. Average administrative costs 
for each clinician or facility = $10,895.
---------------------------------------------------------------------------

    Pharmacies would be classified under NAICS code 446110 (Pharmacies 
and Drug Stores) with a size standard of $30 million or less. The 
Departments assume that 10 pharmacy chains would participate in the 
individual contraceptive arrangement and would incur costs related to 
signing agreements with participating issuers, eligibility 
verification, and recordkeeping. As discussed earlier in section VI.D 
of this preamble, these costs per pharmacy chain are estimated to be 
approximately $728,781 annually.\178\ These costs would likely be 
accounted for in amounts submitted to participating issuers for 
reimbursement by the Federal Government. The major pharmacy chains 
would not fall below this size threshold. The Departments assume that 
independent pharmacies or small pharmacy chains would not participate 
in the individual contraceptive arrangement if it results in a decline 
in their revenues or profitability.
---------------------------------------------------------------------------

    \178\ Total administrative costs for 10 pharmacy chains = 
$41,300 in administrative costs for signed agreements + $7,246,512 
in administrative costs related to providing contraceptive services 
= $7,287,812. Average administrative costs for each pharmacy chain = 
$728,781.
---------------------------------------------------------------------------

    Therefore, the Departments do not anticipate that participation in 
the individual contraceptive arrangement would have a significant 
effect on a substantial number of small entities. The Departments seek 
comment on this analysis.
    In addition, section 1102(b) of the Social Security Act requires 
HHS to prepare a regulatory impact analysis if a rule may have a 
significant economic impact on the operations of a substantial number 
of small rural hospitals. This analysis must conform to the provisions 
of section 604 of the RFA. This rule is not subject to section 1102 of 
the Social Security Act, HHS does not expect that these proposed rules 
would have a significant economic impact on the operations of a 
substantial number of small rural hospitals. Some providers of 
contraceptive services might be affiliated with small rural hospitals, 
and these providers might choose to participate in the individual 
contraceptive arrangement and therefore incur related costs, which 
would ultimately be reimbursed by the Federal Government.

G. Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 
requires that agencies assess anticipated costs and benefits and take 
certain other actions before issuing a proposed rule or any final rule 
for which a general notice of proposed rulemaking was published that 
includes any Federal mandate that may result in expenditures in any 1 
year by State, local, or Tribal governments, in the aggregate, or by 
the private sector, of $100 million in 1995 dollars, updated annually 
for inflation. In 2022, that threshold is approximately $165 million. 
As discussed earlier in section VI of this preamble, providers of 
contraceptive services and issuers that choose to participate in the 
individual contraceptive arrangement would incur costs to comply with 
the proposed provisions of these proposed rules,

[[Page 7271]]

which would likely be reimbursed and ultimately incurred by the Federal 
Government. The Departments estimate the combined impact on State, 
local, or Tribal governments and the private sector would not be above 
the threshold.

H. Federalism

    Executive Order 13132 outlines fundamental principles of 
federalism. It requires adherence to specific criteria by Federal 
agencies in formulating and implementing policies that have 
``substantial direct effects'' on the states, the relationship between 
the national government and states, or on the distribution of power and 
responsibilities among the various levels of government. Federal 
agencies promulgating regulations that have these federalism 
implications must consult with State and local officials and describe 
the extent of their consultation and the nature of the concerns of 
State and local officials in the preamble to the proposed rules.
    The Departments do not anticipate that these proposed rules would 
have any federalism implications or limit the policy making discretion 
of the states, in compliance with the requirement of Executive Order 
13132.
    While developing this rule, the Departments attempted to balance 
the states' interests in regulating health insurance issuers with the 
need to ensure market stability. By doing so, the Departments complied 
with the requirements of Executive Order 13132.

List of Subjects

26 CFR Part 54

    Excise taxes, Health care, Health insurance, Pensions, Reporting 
and recordkeeping requirements.

29 CFR Part 2590

    Continuation coverage, Disclosure, Employee benefit plans, Group 
health plans, Health care, Health insurance, Medical child support, 
Reporting and recordkeeping requirements.

45 CFR Part 147

    Aged, Citizenship and naturalization, Civil rights, Health care, 
Health insurance, Individuals with disabilities, Intergovernmental 
relations, Reporting and recordkeeping requirements, Sex 
discrimination.

45 CFR Part 156

    Administrative practice and procedure, Advertising, Advisory 
committees, Aged, Alaska, Brokers, Citizenship and naturalization, 
Civil rights, Conflicts of interests, Consumer protection, Grant 
programs-health, Grants administration, Health care, Health insurance, 
Health maintenance organizations (HMO), Health records, Hospitals, 
Indians, Individuals with disabilities, Intergovernmental relations, 
Loan programs-health, Medicaid, Organization and functions (Government 
agencies), Prescription drugs, Public assistance programs, Reporting 
and recordkeeping requirements, Sex discrimination, State and local 
governments, Sunshine Act, Technical assistance, Women, Youth.

DEPARTMENT OF THE TREASURY

Internal Revenue Service

    Accordingly, the Treasury Department and the IRS propose to amend 
26 CFR part 54 as follows:

PART 54--PENSION EXCISE TAXES

0
Paragraph 1.The authority citation for part 54 continues to read as 
follows:

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

0
Par 2. Section 54.9815-2713 is amended by revising paragraphs (a)(1) 
introductory text and (a)(1)(iv) to read as follows:


Sec.  54.9815-2713  Coverage of preventive health services.

    (a) * * *
    (1) In general. Beginning at the time described in paragraph (b) of 
this section, a group health plan, or a health insurance issuer 
offering group health insurance coverage, must provide coverage for and 
must not impose any cost-sharing requirements (such as a copayment, 
coinsurance, or a deductible) for--
* * * * *
    (iv) With respect to women, such additional preventive care and 
screenings not described in paragraph (a)(1)(i) of this section as 
provided for in evidence-informed comprehensive guidelines supported by 
the Health Resources and Services Administration for purposes of 
section 2713(a)(4) of the Public Health Service Act, subject to 45 CFR 
147.131 and 147.132.
* * * * *
0
Par 3. Section 54.9815-2713A is revised to read as follows:


Sec.  54.9815-2713A   Alternate availability of certain preventive 
health services.

    (a) Organizations eligible for optional accommodations and 
individuals eligible for individual contraceptive arrangements. (1) An 
eligible organization is an organization that meets the criteria of 
paragraphs (a)(1)(i) through (iii) of this section.
    (i) The organization is an objecting entity described in 45 CFR 
147.132(a)(1)(i) through (iii);
    (ii) Notwithstanding its exempt status under 45 CFR 147.132(a), the 
organization voluntarily seeks to be considered an eligible 
organization to invoke the optional accommodation under paragraph (b) 
or (c) of this section; and
    (iii) The organization self-certifies in the form and manner 
specified by the Secretary of Labor or provides notice to the Secretary 
of Health and Human Services as described in paragraph (b) or (c) of 
this section. To qualify as an eligible organization, the organization 
must make such self-certification or notice available for examination 
upon request by the first day of the first plan year to which the 
accommodation in paragraph (b) or (c) of this section applies. The 
self-certification or notice must be executed by a person authorized to 
make the certification or provide the notice on behalf of the 
organization and must be maintained in a manner consistent with the 
record retention requirements under section 107 of ERISA.
    (2) An eligible organization may revoke its use of the 
accommodation under paragraph (b) or (c) of this section, and its 
issuer or third party administrator must provide participants and 
beneficiaries written notice of the revocation; the eligible 
organization's revocation of the accommodation will 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.
    (3) An eligible individual is an individual who--
    (i) Is a participant or beneficiary enrolled in a group health plan 
established or maintained by an objecting entity described in 45 CFR 
147.132(a) that, to the extent eligible, has not invoked the optional 
accommodation under paragraph (b) or (c) of this section; and
    (ii) Confirms (such as by making an attestation) to a provider of 
contraceptive services that agrees to meet the conditions in paragraph 
(d)(1) of this section that the individual is enrolled in a group 
health plan or group health insurance coverage that does not provide 
coverage for all or a subset of contraceptive services as generally 
required under Sec.  54.9815-2713(a)(1)(iv).
    (b) Optional accommodation--self-insured group health plans. (1) A 
group health plan established or maintained by an eligible organization 
that provides benefits on a self-insured basis may voluntarily elect an 
optional accommodation under which its third party administrator(s) 
will provide or arrange payments for all or a subset of contraceptive 
services for one or more

[[Page 7272]]

plan years. To invoke the optional accommodation process:
    (i) Except as provided in paragraph (b)(5) of this section, the 
eligible organization or its plan must contract with one or more third 
party administrators.
    (ii) The eligible organization must provide either a copy of the 
self-certification to each third party administrator it contracts with 
to provide administrative services in connection with the plan or a 
notice to the Secretary of Health and Human Services that it is an 
eligible organization and of its objection as described in 45 CFR 
147.132 to coverage of all or a subset of contraceptive services.
    (A) When a copy of the self-certification is provided directly to a 
third party administrator, the self-certification must include a notice 
that obligations of the third party administrator are set forth in in 
29 CFR 2510.3-16 and this section.
    (B) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible 
organization; a statement that it objects as described in 45 CFR 
147.132 to coverage of some or all contraceptive services (including an 
identification of the subset of contraceptive services the eligible 
organization objects to covering, if applicable), but that it would 
like to elect the optional accommodation process; the plan name and 
type (that is, whether it is student health insurance coverage within 
the meaning of 45 CFR 147.145(a) or a church plan within the meaning of 
section 414(e) or section 3(33) of ERISA); and the name and contact 
information for any of the plan's third party administrators. If there 
is a change in any of the information required to be included in the 
notice, the eligible organization must provide updated information to 
the Secretary of Health and Human Services for the optional 
accommodation process to remain in effect. The Department of Labor 
(working with the Department of Health and Human Services) will send a 
separate notification to each of the plan's third party administrators 
informing the third party administrator that the Secretary of Health 
and Human Services has received a notice under paragraph (b)(1)(ii) of 
this section and describing the obligations of the third party 
administrator under 29 CFR 2510.3-16(c) and this section.
    (2) If a third party administrator receives a copy of the self-
certification from an eligible organization or a notification from the 
Department of Labor, as described in paragraph (b)(1)(ii) of this 
section and is willing to enter into or remain in a contractual 
relationship with the eligible organization or its plan to provide 
administrative services for the plan, then the third party 
administrator will provide or arrange payments for contraceptive 
services, using one of the following methods--
    (i) Provide payments for the contraceptive services for plan 
participants and beneficiaries without imposing any cost-sharing 
requirements (such as a copayment, coinsurance, or a deductible), 
premium, fee, or other charge, or any portion thereof, directly or 
indirectly, on the eligible organization, the group health plan, or 
plan participants or beneficiaries; or
    (ii) Arrange for an issuer or other entity to provide payments for 
contraceptive services for plan participants and beneficiaries without 
imposing any cost-sharing requirements (such as a copayment, 
coinsurance, or a deductible), premium, fee, or other charge, or any 
portion thereof, directly or indirectly, on the eligible organization, 
the group health plan, or plan participants or beneficiaries.
    (3) If a third party administrator provides or arranges payments 
for contraceptive services in accordance with either paragraph 
(b)(2)(i) or (ii) of this section, the costs of providing or arranging 
such payments may be reimbursed through an adjustment to the Federally-
facilitated Exchange or State Exchange on the Federal platform user 
fees for a participating issuer pursuant to 45 CFR 156.50(d).
    (4) A third party administrator may not require any documentation 
other than a copy of the self-certification from the eligible 
organization or notification from the Department of Labor described in 
paragraph (b)(1)(ii) of this section.
    (5) Where an otherwise eligible organization does not contract with 
a third party administrator and it files a self-certification or notice 
under paragraph (b)(1)(ii) of this section, the obligations under 
paragraph (b)(2) of this section do not apply, and the otherwise 
eligible organization is not required to provide coverage or payments 
for contraceptive services to which it objects. The plan administrator 
for that otherwise eligible organization may, if it and the otherwise 
eligible organization choose, arrange for payments for contraceptive 
services from an issuer or other entity in accordance with paragraph 
(b)(2)(ii) of this section, and such issuer or other entity may receive 
reimbursements in accordance with paragraph (b)(3) of this section.
    (6) Where an otherwise eligible organization is a church plan 
within the meaning of section 3(33) of ERISA or section 414(e) and it 
files a self-certification or notice under paragraph (b)(1)(ii) of this 
section, the obligations under paragraph (b)(2) of this section do not 
apply, and the otherwise eligible organization is under no requirement 
to provide coverage or payments for contraceptive services to which it 
objects. The third party administrator for that otherwise eligible 
organization may, if it and the otherwise eligible organization choose, 
provide or arrange payments for contraceptive services in accordance 
with paragraph (b)(2)(i) or (ii) of this section, and receive 
reimbursements in accordance with paragraph (b)(3) of this section.
    (c) Optional accommodation--insured group health plans--(1) A group 
health plan established or maintained by an eligible organization that 
provides benefits through one or more group health insurance issuers 
may voluntarily elect an optional accommodation under which its health 
insurance issuer(s) will provide payments for all or a subset of 
contraceptive services for one or more plan years. To invoke the 
optional accommodation process:
    (i) The eligible organization or its plan must contract with one or 
more health insurance issuers.
    (ii) The eligible organization must provide either a copy of the 
self-certification to each issuer it contracts with to provide coverage 
in connection with the plan or a notice to the Secretary of Health and 
Human Services that it is an eligible organization and of its objection 
as described in 45 CFR 147.132 to coverage for all or a subset of 
contraceptive services.
    (A) When a copy of the self-certification is provided directly to 
an issuer, the issuer has sole responsibility for providing such 
coverage in accordance with Sec.  54.9815-2713(a)(1)(iv).
    (B) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible 
organization; a statement that it objects as described in 45 CFR 
147.132 to coverage of some or all contraceptive services (including an 
identification of the subset of contraceptive services to which 
coverage the eligible organization objects, if applicable), but that it 
would like to elect the optional accommodation process; the plan name 
and type (that is, whether it is student health insurance coverage 
within the meaning of 45 CFR 147.145(a) or a church plan within the 
meaning of

[[Page 7273]]

section 414(e) or section 3(33) of ERISA); and the name and contact 
information for any of the plan's health insurance issuers. If there is 
a change in any of the information required to be included in the 
notice, the eligible organization must provide updated information to 
the Secretary of Health and Human Services for the optional 
accommodation to remain in effect. The Department of Health and Human 
Services will send a separate notification to each of the plan's health 
insurance issuers informing the issuer that the Secretary of Health and 
Human Services has received a notice under paragraph (c)(1)(ii) of this 
section and describing the obligations of the issuer under this 
section.
    (2) If an issuer receives a copy of the self-certification from an 
eligible organization or the notification from the Department of Health 
and Human Services as described in paragraph (c)(1)(ii) of this section 
and does not have an objection as described in 45 CFR 147.132 to 
providing the contraceptive services identified in the self-
certification or the notification from the Department of Health and 
Human Services, the issuer will provide payments for contraceptive 
services as follows--
    (i) The issuer must expressly exclude contraceptive coverage from 
the group health insurance coverage provided in connection with the 
group health plan and provide separate payments for any contraceptive 
services required to be covered under Sec.  54.9815-2713(a)(1)(iv) for 
plan participants and beneficiaries for so long as they remain enrolled 
in the plan.
    (ii) With respect to payments for contraceptive services, the 
issuer may not impose any cost-sharing requirements (such as a 
copayment, coinsurance, or a deductible), premium, fee, or other 
charge, or any portion thereof, directly or indirectly, on the eligible 
organization, the group health plan, or plan participants or 
beneficiaries. The issuer must segregate premium revenue collected from 
the eligible organization from the monies used to provide payments for 
contraceptive services. The issuer must provide payments for 
contraceptive services in a manner that is consistent with the 
requirements under sections 2706, 2709, 2711, 2713, and 2719 of the PHS 
Act, as incorporated into section 9815, and section 9822. If the group 
health plan of the eligible organization provides coverage for some but 
not all of any contraceptive services required to be covered under 
Sec.  54.9815-2713(a)(1)(iv), the issuer is required to provide 
payments only for those contraceptive services for which the group 
health plan does not provide coverage. However, the issuer may provide 
payments for all contraceptive services at the issuer's option.
    (3) A health insurance issuer may not require any documentation 
other than a copy of the self-certification from the eligible 
organization or the notification from the Department of Health and 
Human Services described in paragraph (c)(1)(ii) of this section.
    (d) Notice of availability of separate payments for contraceptive 
services--self-insured and insured group health plans. For each plan 
year to which the optional accommodation in paragraph (b) or (c) of 
this section is to apply, a third party administrator required to 
provide or arrange payments for contraceptive services pursuant to 
paragraph (b) of this section, and an issuer required to provide 
payments for contraceptive services pursuant to paragraph (c) of this 
section, must provide to plan participants and beneficiaries written 
notice of the availability of separate payments for contraceptive 
services contemporaneous with (to the extent possible), but separate 
from, any application materials distributed in connection with 
enrollment (or re-enrollment) in group health coverage that is 
effective beginning on the first day of each applicable plan year. The 
notice must specify that the eligible organization does not administer 
or fund contraceptive benefits, but that the third party administrator 
or issuer, as applicable, provides or arranges separate payments for 
contraceptive services, and must provide contact information for 
questions and complaints. The following model language, or 
substantially similar language, may be used to satisfy the notice 
requirement of this paragraph (d): ``Your employer has certified that 
your group health plan qualifies for an accommodation with respect to 
the Federal requirement to cover contraceptive services for women, 
including all Food and Drug Administration-approved, cleared, or 
granted contraceptives, as prescribed by a health care provider, 
without cost sharing. This means that your employer will not contract, 
arrange, pay, or refer for contraceptive coverage. Instead, [name of 
third party administrator/health insurance issuer] will provide 
separate payments for contraceptive services that you use, without cost 
sharing and at no other cost, for so long as you are enrolled in your 
group health plan. Your employer will not administer or fund these 
payments. If you have any questions about this notice, contact [contact 
information for third party administrator/health insurance issuer].''
    (e) Individual contraceptive arrangements for eligible individuals. 
(1) An eligible individual may elect an individual contraceptive 
arrangement under which a willing provider of contraceptive services 
furnishes the eligible individual with contraceptive services that a 
group health plan or health insurance issuer would have been required 
to cover pursuant to Sec.  54.9815-2713(a)(1)(iv), if not for the 
plan's or issuer's exempt status under 45 CFR 147.132(a). Under this 
individual contraceptive arrangement, the willing provider of 
contraceptive services must furnish contraceptive services (including 
items and services that are integral to the furnishing of the 
contraceptive services) to the eligible individual without imposing a 
fee or charge of any kind, directly or indirectly, on the eligible 
individual or any other entity for the cost of the items and services 
or any portion thereof, except that the provider of contraceptive 
services may seek payment from, and be reimbursed by, an issuer for the 
costs of providing the items and services through an adjustment to the 
issuer's Federally-facilitated Exchange or State Exchange on the 
Federal platform user fees pursuant to 45 CFR 156.50(d).
    (2) The following language may, but is not required to, be used by 
a participant or beneficiary (or an authorized representative of a 
participant or beneficiary) to confirm to a provider of contraceptive 
services that the plan or coverage is sponsored, provided, or arranged 
by an objecting entity and does not provide coverage for all or a 
subset of contraceptive services as generally required under Sec.  
54.9815-2713(a)(1)(iv): ``I certify that I am enrolled (or am an 
authorized representative of a person who is enrolled) in an employer-
sponsored health plan or health insurance coverage that does not 
provide coverage for all or a subset of contraceptive services as 
generally required under the Affordable Care Act.'' A participant or 
beneficiary (or an authorized representative of a participant or 
beneficiary) may use other means to confirm to a provider of 
contraceptive services that the plan or coverage is sponsored, 
provided, or arranged by an objecting entity and does not provide 
coverage for all or a subset of contraceptive services.
    (f) Reliance--insured group health plans. (1) If an issuer 
reasonably and in good faith relies on a representation by an eligible 
organization indicating that the organization is eligible for the 
accommodation in paragraph (c) of this section, and the representation 
is later

[[Page 7274]]

determined to be incorrect, the issuer is considered to comply with any 
applicable requirement under Sec.  54.9815-2713(a)(1)(iv) to provide 
contraceptive coverage if the issuer complies with the obligations 
under this section applicable to such issuer.
    (2) A group health plan is considered to comply with any applicable 
requirement under Sec.  54.9815-2713(a)(1)(iv) to provide contraceptive 
coverage if the plan complies with its obligations under paragraph (c) 
of this section, without regard to whether the issuer complies with the 
obligations under this section applicable to such issuer.
    (g) Definitions. (1) For the purposes of this section, reference to 
``contraceptive'' services, benefits, or coverage includes 
contraceptive or sterilization items, procedures, or services, or 
related patient education or counseling, to the extent specified for 
purposes of Sec.  54.9815-2713(a)(1)(iv).
    (2) For the purposes of this section, the term ``provider of 
contraceptive services'' means any health care provider (including a 
clinician, pharmacy, or other facility) acting within the scope of that 
provider's license, certification, or authority under applicable law to 
provide contraceptive services (as defined in paragraph (g)(1) of this 
section).
    (h) Severability. Any provision of this section held to be invalid 
or unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this section and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.

DEPARTMENT OF LABOR

Employee Benefits Security Administration

    For the reasons stated in the preamble, the Department of Labor 
proposes to amend 29 CFR part 2590 as set forth below:

PART 2590--RULES AND REGULATIONS FOR GROUP HEALTH PLANS

0
4. The authority citation for part 2590 continues to read as follows:

    Authority: 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-
1183, 1181 note, 1185, 1185a-n, 1191, 1191a, 1191b, and 1191c; sec. 
101(g), Pub. L.104-191, 110 Stat. 1936; sec. 401(b), Pub. L. 105-
200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-
343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148, 
124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 1029; 
Division M, Pub. L. 113-235, 128 Stat. 2130; Pub. L. 116-260 134 
Stat. 1182; Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 
2012).

0
5. Section 2590.715-2713 is amended by revising paragraphs (a)(1) 
introductory text and (a)(1)(iv) to read as follows:


Sec.  2590.715-2713  Coverage of preventive health services.

    (a) * * *
    (1) In general. Beginning at the time described in paragraph (b) of 
this section, a group health plan, or a health insurance issuer 
offering group health insurance coverage, must provide coverage for and 
must not impose any cost-sharing requirements (such as a copayment, 
coinsurance, or a deductible) for--
* * * * *
    (iv) With respect to women, such additional preventive care and 
screenings not described in paragraph (a)(1)(i) of this section as 
provided for in evidence-informed comprehensive guidelines supported by 
the Health Resources and Services Administration for purposes of 
section 2713(a)(4) of the Public Health Service Act, subject to 45 CFR 
147.131 and 147.132; and
* * * * *
0
6. Section 2590.715-2713A is revised to read as follows:


Sec.  2590.715-2713A  Alternate availability of certain preventive 
health services.

    (a) Organizations eligible for optional accommodations and 
individuals eligible for individual contraceptive arrangements.
    (1) An eligible organization is an organization that meets the 
criteria of paragraphs (a)(1)(i) through (iii) of this section.
    (i) The organization is an objecting entity described in 45 CFR 
147.132(a)(1)(i) through (iii);
    (ii) Notwithstanding its exempt status under 45 CFR 147.132(a), the 
organization voluntarily seeks to be considered an eligible 
organization to invoke the optional accommodation under paragraph (b) 
or (c) of this section; and
    (iii) The organization self-certifies in the form and manner 
specified by the Secretary or provides notice to the Secretary of 
Health and Human Services as described in paragraph (b) or (c) of this 
section. To qualify as an eligible organization, the organization must 
make such self-certification or notice available for examination upon 
request by the first day of the first plan year to which the 
accommodation in paragraph (b) or (c) of this section applies. The 
self-certification or notice must be executed by a person authorized to 
make the certification or provide the notice on behalf of the 
organization and must be maintained in a manner consistent with the 
record retention requirements under section 107 of ERISA.
    (2) An eligible organization may revoke its use of the 
accommodation under paragraph (b) or (c) of this section, and its 
issuer or third party administrator must provide participants and 
beneficiaries written notice of the revocation; the eligible 
organization's revocation of the accommodation will 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.
    (3) An eligible individual is an individual who--
    (i) Is a participant or beneficiary enrolled in a group health plan 
established or maintained by an objecting entity described in 45 CFR 
147.132(a) that, to the extent eligible, has not invoked the optional 
accommodation under paragraph (b) or (c) of this section; and
    (ii) Confirms (such as by making an attestation) to a provider of 
contraceptive services that agrees to meet the conditions in paragraph 
(d)(1) of this section that the individual is enrolled in a group 
health plan or group health insurance coverage that does not provide 
coverage for all or a subset of contraceptive services as generally 
required under Sec.  2590.715-2713(a)(1)(iv).
    (b) Optional accommodation--self-insured group health plans. (1) A 
group health plan established or maintained by an eligible organization 
that provides benefits on a self-insured basis may voluntarily elect an 
optional accommodation under which its third party administrator(s) 
will provide or arrange payments for all or a subset of contraceptive 
services for one or more plan years. To invoke the optional 
accommodation process:
    (i) Except as provided in paragraph (b)(5) of this section, the 
eligible organization or its plan must contract with one or more third 
party administrators.
    (ii) The eligible organization must provide either a copy of the 
self-certification to each third party administrator it contracts with 
to provide administrative services in connection with the plan or a 
notice to the Secretary of Health and Human Services that it is an 
eligible

[[Page 7275]]

organization and of its objection as described in 45 CFR 147.132 to 
coverage of all or a subset of contraceptive services.
    (A) When a copy of the self-certification is provided directly to a 
third party administrator, the self-certification must include a notice 
that obligations of the third party administrator are set forth in 
Sec.  2510.3-16 of this chapter and this section.
    (B) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible 
organization; a statement that it objects as described in 45 CFR 
147.132 to coverage of some or all contraceptive services (including an 
identification of the subset of contraceptive services the eligible 
organization objects to covering, if applicable), but that it would 
like to elect the optional accommodation process; the plan name and 
type (that is, whether it is student health insurance coverage within 
the meaning of 45 CFR 147.145(a) or a church plan within the meaning of 
section 414(e) of the Internal Revenue Code or section 3(33) of ERISA); 
and the name and contact information for any of the plan's third party 
administrators. If there is a change in any of the information required 
to be included in the notice, the eligible organization must provide 
updated information to the Secretary of Health and Human Services for 
the optional accommodation process to remain in effect. The Department 
of Labor (working with the Department of Health and Human Services) 
will send a separate notification to each of the plan's third party 
administrators informing the third party administrator that the 
Secretary of Health and Human Services has received a notice under 
paragraph (b)(1)(ii) of this section and describing the obligations of 
the third party administrator under Sec.  2510.3-16(c) of this chapter 
and this section.
    (2) If a third party administrator receives a copy of the self-
certification from an eligible organization or a notification from the 
Department of Labor, as described in paragraph (b)(1)(ii) of this 
section and is willing to enter into or remain in a contractual 
relationship with the eligible organization or its plan to provide 
administrative services for the plan, then the third party 
administrator will provide or arrange payments for contraceptive 
services, using one of the following methods--
    (i) Provide payments for the contraceptive services for plan 
participants and beneficiaries without imposing any cost-sharing 
requirements (such as a copayment, coinsurance, or a deductible), 
premium, fee, or other charge, or any portion thereof, directly or 
indirectly, on the eligible organization, the group health plan, or 
plan participants or beneficiaries; or
    (ii) Arrange for an issuer or other entity to provide payments for 
contraceptive services for plan participants and beneficiaries without 
imposing any cost-sharing requirements (such as a copayment, 
coinsurance, or a deductible), premium, fee, or other charge, or any 
portion thereof, directly or indirectly, on the eligible organization, 
the group health plan, or plan participants or beneficiaries.
    (3) If a third party administrator provides or arranges payments 
for contraceptive services in accordance with either paragraph 
(b)(2)(i) or (ii) of this section, the costs of providing or arranging 
such payments may be reimbursed through an adjustment to the Federally-
facilitated Exchange or State Exchange on the Federal platform user 
fees for a participating issuer pursuant to 45 CFR 156.50(d).
    (4) A third party administrator may not require any documentation 
other than a copy of the self-certification from the eligible 
organization or notification from the Department of Labor described in 
paragraph (b)(1)(ii) of this section.
    (5) Where an otherwise eligible organization does not contract with 
a third party administrator and it files a self-certification or notice 
under paragraph (b)(1)(ii) of this section, the obligations under 
paragraph (b)(2) of this section do not apply, and the otherwise 
eligible organization is not required to provide coverage or payments 
for contraceptive services to which it objects. The plan administrator 
for that otherwise eligible organization may, if it and the otherwise 
eligible organization choose, arrange for payments for contraceptive 
services from an issuer or other entity in accordance with paragraph 
(b)(2)(ii) of this section, and such issuer or other entity may receive 
reimbursements in accordance with paragraph (b)(3) of this section.
    (c) Optional accommodation--insured group health plans. (1) A group 
health plan established or maintained by an eligible organization that 
provides benefits through one or more group health insurance issuers 
may voluntarily elect an optional accommodation under which its health 
insurance issuer(s) will provide payments for all or a subset of 
contraceptive services for one or more plan years. To invoke the 
optional accommodation process:
    (i) The eligible organization or its plan must contract with one or 
more health insurance issuers.
    (ii) The eligible organization must provide either a copy of the 
self-certification to each issuer it contracts with to provide coverage 
in connection with the plan or a notice to the Secretary of Health and 
Human Services that it is an eligible organization and of its objection 
as described in 45 CFR 147.132 to coverage for all or a subset of 
contraceptive services.
    (A) When a copy of the self-certification is provided directly to 
an issuer, the issuer has sole responsibility for providing such 
coverage in accordance with Sec.  2590.715-2713(a)(1)(iv).
    (B) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible 
organization; a statement that it objects as described in 45 CFR 
147.132 to coverage of some or all contraceptive services (including an 
identification of the subset of contraceptive services to which 
coverage the eligible organization objects, if applicable), but that it 
would like to elect the optional accommodation process; the plan name 
and type (that is, whether it is student health insurance coverage 
within the meaning of 45 CFR 147.145(a) or a church plan within the 
meaning of section 414(e) of the Internal Revenue Code or section 3(33) 
of ERISA); and the name and contact information for any of the plan's 
health insurance issuers. If there is a change in any of the 
information required to be included in the notice, the eligible 
organization must provide updated information to the Secretary of 
Health and Human Services for the optional accommodation to remain in 
effect. The Department of Health and Human Services will send a 
separate notification to each of the plan's health insurance issuers 
informing the issuer that the Secretary of Health and Human Services 
has received a notice under paragraph (c)(1)(ii) of this section and 
describing the obligations of the issuer under this section.
    (2) If an issuer receives a copy of the self-certification from an 
eligible organization or the notification from the Department of Health 
and Human Services as described in paragraph (c)(1)(ii) of this section 
and does not have an objection as described in 45 CFR 147.132 to 
providing the contraceptive services identified in the self-
certification or the notification from the Department of Health and 
Human Services, the issuer will provide

[[Page 7276]]

payments for contraceptive services as follows--
    (i) The issuer must expressly exclude contraceptive coverage from 
the group health insurance coverage provided in connection with the 
group health plan and provide separate payments for any contraceptive 
services required to be covered under Sec.  2590.715-2713(a)(1)(iv) for 
plan participants and beneficiaries for so long as they remain enrolled 
in the plan.
    (ii) With respect to payments for contraceptive services, the 
issuer may not impose any cost-sharing requirements (such as a 
copayment, coinsurance, or a deductible), premium, fee, or other 
charge, or any portion thereof, directly or indirectly, on the eligible 
organization, the group health plan, or plan participants or 
beneficiaries. The issuer must segregate premium revenue collected from 
the eligible organization from the monies used to provide payments for 
contraceptive services. The issuer must provide payments for 
contraceptive services in a manner that is consistent with the 
requirements under sections 2706, 2709, 2711, 2713, and 2719 of the PHS 
Act, as incorporated into section 715 of ERISA, and section 722 of 
ERISA. If the group health plan of the eligible organization provides 
coverage for some but not all of any contraceptive services required to 
be covered under Sec.  2590.715-2713(a)(1)(iv), the issuer is required 
to provide payments only for those contraceptive services for which the 
group health plan does not provide coverage. However, the issuer may 
provide payments for all contraceptive services at the issuer's option.
    (3) A health insurance issuer may not require any documentation 
other than a copy of the self-certification from the eligible 
organization or the notification from the Department of Health and 
Human Services described in paragraph (c)(1)(ii) of this section.
    (d) Notice of availability of separate payments for contraceptive 
services--self-insured and insured group health plans. For each plan 
year to which the optional accommodation in paragraph (b) or (c) of 
this section is to apply, a third party administrator required to 
provide or arrange payments for contraceptive services pursuant to 
paragraph (b) of this section, and an issuer required to provide 
payments for contraceptive services pursuant to paragraph (c) of this 
section, must provide to plan participants and beneficiaries written 
notice of the availability of separate payments for contraceptive 
services contemporaneous with (to the extent possible), but separate 
from, any application materials distributed in connection with 
enrollment (or re-enrollment) in group health coverage that is 
effective beginning on the first day of each applicable plan year. The 
notice must specify that the eligible organization does not administer 
or fund contraceptive benefits, but that the third party administrator 
or issuer, as applicable, provides or arranges separate payments for 
contraceptive services, and must provide contact information for 
questions and complaints. The following model language, or 
substantially similar language, may be used to satisfy the notice 
requirement of this paragraph (d): ``Your employer has certified that 
your group health plan qualifies for an accommodation with respect to 
the Federal requirement to cover contraceptive services for women, 
including all Food and Drug Administration-approved, cleared, or 
granted contraceptives, as prescribed by a health care provider, 
without cost sharing. This means that your employer will not contract, 
arrange, pay, or refer for contraceptive coverage. Instead, [name of 
third party administrator/health insurance issuer] will provide 
separate payments for contraceptive services that you use, without cost 
sharing and at no other cost, for so long as you are enrolled in your 
group health plan. Your employer will not administer or fund these 
payments. If you have any questions about this notice, contact [contact 
information for third party administrator/health insurance issuer].''
    (e) Individual contraceptive arrangements for eligible individuals. 
(1) An eligible individual may elect an individual contraceptive 
arrangement under which a willing provider of contraceptive services 
furnishes the eligible individual with contraceptive services that a 
group health plan or health insurance issuer would have been required 
to cover pursuant to Sec.  2590.715-2713(a)(1)(iv), if not for the 
plan's or issuer's exempt status under 45 CFR 147.132(a). Under this 
individual contraceptive arrangement, the willing provider of 
contraceptive services must furnish contraceptive services (including 
items and services that are integral to the furnishing of the 
contraceptive services) to the eligible individual without imposing a 
fee or charge of any kind, directly or indirectly, on the eligible 
individual or any other entity for the cost of the items and services 
or any portion thereof, except that the provider of contraceptive 
services may seek payment from, and be reimbursed by, an issuer for the 
costs of providing the items and services through an adjustment to the 
issuer's Federally-facilitated Exchange or State Exchange on the 
Federal platform user fees pursuant to 45 CFR 156.50(d).
    (2) The following language may, but is not required to, be used by 
a participant or beneficiary (or an authorized representative of a 
participant or beneficiary) to confirm to a provider of contraceptive 
services that the plan or coverage is sponsored, provided, or arranged 
by an objecting entity and does not provide coverage for all or a 
subset of contraceptive services as generally required under Sec.  
2590.715-2713(a)(1)(iv): ``I certify that I am enrolled (or am an 
authorized representative of a person who is enrolled) in an employer-
sponsored health plan or health insurance coverage that does not 
provide coverage for all or a subset of contraceptive services as 
generally required under the Affordable Care Act.'' A participant or 
beneficiary (or an authorized representative of a participant or 
beneficiary) may use other means to confirm to a provider of 
contraceptive services that the plan or coverage is sponsored, 
provided, or arranged by an objecting entity and does not provide 
coverage for all or a subset of contraceptive services.
    (f) Reliance--insured group health plans. (1) If an issuer 
reasonably and in good faith relies on a representation by an eligible 
organization indicating that the organization is eligible for the 
accommodation in paragraph (c) of this section, and the representation 
is later determined to be incorrect, the issuer is considered to comply 
with any applicable requirement under Sec.  2590.715-2713(a)(1)(iv) to 
provide contraceptive coverage if the issuer complies with the 
obligations under this section applicable to such issuer.
    (2) A group health plan is considered to comply with any applicable 
requirement under Sec.  2590.715-2713(a)(1)(iv) to provide 
contraceptive coverage if the plan complies with its obligations under 
paragraph (c) of this section, without regard to whether the issuer 
complies with the obligations under this section applicable to such 
issuer.
    (g) Definitions. (1) For the purposes of this section, reference to 
``contraceptive'' services, benefits, or coverage includes 
contraceptive or sterilization items, procedures, or services, or 
related patient education or counseling, to the extent specified for 
purposes of Sec.  2590.715-2713(a)(1)(iv).
    (2) For the purposes of this section, the term ``provider of 
contraceptive services'' means any health care provider (including a 
clinician, pharmacy, or other facility) acting

[[Page 7277]]

within the scope of that provider's license, certification, or 
authority under applicable law to provide contraceptive services (as 
defined in paragraph (g)(1) of this section).
    (h) Severability. Any provision of this section held to be invalid 
or unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this section and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

    For the reasons stated in the preamble, the Department of Health 
and Human Services proposes to amend 45 CFR parts 147 and 156 as set 
forth below:

PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND 
INDIVIDUAL HEALTH INSURANCE MARKETS

0
7. The authority citation for part 147 continues to read as follows:

    Authority: 42 U.S.C. 300gg through 300gg-63, 300gg-91, 300gg-92, 
and 300gg-111 through 300gg-139, as amended, and section 3203, Pub. 
L. 116-136, 134 Stat. 281.

0
8. Section 147.130 is amended by revising paragraphs (a)(1) 
introductory text and (a)(1)(iv) to read as follows:


Sec.  147.130  Coverage of preventive health services.

    (a) * * *
    (1) In general. Beginning at the time described in paragraph (b) of 
this section, a group health plan, or a health insurance issuer 
offering group or individual health insurance coverage, must provide 
coverage for and must not impose any cost-sharing requirements (such as 
a copayment, coinsurance, or a deductible) for--
* * * * *
    (iv) With respect to women, such additional preventive care and 
screenings not described in paragraph (a)(1)(i) of this section as 
provided for in evidence-informed comprehensive guidelines supported by 
the Health Resources and Services Administration for purposes of 
section 2713(a)(4) of the Public Health Service Act, subject to 
Sec. Sec.  147.131 and 147.132; and
* * * * *
0
9. Section 147.131 is revised to read as follows:


Sec.  147.131  Alternate availability of certain preventive health 
services.

    (a) Organizations eligible for optional accommodations and 
individuals eligible for individual contraceptive arrangements. (1) An 
eligible organization is an organization that meets the criteria of 
paragraphs (a)(1)(i) through (iii) of this section.
    (i) The organization is an objecting entity described in Sec.  
147.132(a)(1)(i) through (iii);
    (ii) Notwithstanding its exempt status under Sec.  147.132(a), the 
organization voluntarily seeks to be considered an eligible 
organization to invoke the optional accommodation under paragraph (b) 
of this section; and
    (iii) The organization self-certifies in the form and manner 
specified by the Secretary of Health and Human Services or provides 
notice to the Secretary of Health and Human Services as described in 
paragraph (b) of this section. To qualify as an eligible organization, 
the organization must make such self-certification or notice available 
for examination upon request by the first day of the first plan year to 
which the accommodation in paragraph (b) of this section applies. The 
self-certification or notice must be executed by a person authorized to 
make the certification or provide the notice on behalf of the 
organization and must be maintained in a manner consistent with the 
record retention requirements under section 107 of ERISA.
    (2) An eligible organization may revoke its use of the 
accommodation under paragraph (b) of this section, and its issuer must 
provide participants and beneficiaries written notice of the 
revocation; the eligible organization's revocation of the accommodation 
will 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.
    (3) An eligible individual is an individual who--
    (i) Is a participant or beneficiary enrolled in a group health plan 
established or maintained, or an enrollee in individual health 
insurance coverage offered or arranged, by an objecting entity 
described in Sec.  147.132(a) that, to the extent eligible, has not 
invoked the optional accommodation under paragraph (b) of this section; 
and
    (ii) Confirms (such as by making an attestation) to a provider of 
contraceptive services that agrees to meet the conditions in paragraph 
(d)(1) of this section that the individual is enrolled in a group 
health plan or group or individual health insurance coverage that does 
not provide coverage for all or a subset of contraceptive services as 
generally required under Sec.  147.130(a)(1)(iv).
    (b) Optional accommodation--insured group health plans. (1) A group 
health plan established or maintained by an eligible organization that 
provides benefits through one or more group health insurance issuers 
may voluntarily elect an optional accommodation under which its health 
insurance issuer(s) will provide payments for all or a subset of 
contraceptive services for one or more plan years. To invoke the 
optional accommodation process:
    (i) The eligible organization or its plan must contract with one or 
more health insurance issuers.
    (ii) The eligible organization must provide either a copy of the 
self-certification to each issuer it contracts with to provide coverage 
in connection with the plan or a notice to the Secretary of Health and 
Human Services that it is an eligible organization and of its objection 
as described in Sec.  147.132 to coverage for all or a subset of 
contraceptive services.
    (A) When a copy of the self-certification is provided directly to 
an issuer, the issuer has sole responsibility for providing such 
coverage in accordance with Sec.  147.130(a)(1)(iv).
    (B) When a notice is provided to the Secretary of Health and Human 
Services, the notice must include the name of the eligible 
organization; a statement that it objects as described in Sec.  147.132 
to coverage of some or all contraceptive services (including an 
identification of the subset of contraceptive services to which 
coverage the eligible organization objects, if applicable), but that it 
would like to elect the optional accommodation process; the plan name 
and type (that is, whether it is student health insurance coverage 
within the meaning of Sec.  147.145(a) or a church plan within the 
meaning of section 3(33) of ERISA or section 414(e) of the Internal 
Revenue Code); and the name and contact information for any of the 
plan's health insurance issuers. If there is a change in any of the 
information required to be included in the notice, the eligible 
organization must provide updated information to the Secretary of 
Health and Human Services for the optional accommodation to remain in 
effect. The Department of Health and Human Services will send a 
separate notification to each of the plan's health insurance issuers 
informing the issuer that the Secretary of Health and Human Services 
has received a notice under paragraph (b)(1)(ii) of this section and

[[Page 7278]]

describing the obligations of the issuer under this section.
    (2) If an issuer receives a copy of the self-certification from an 
eligible organization or the notification from the Department of Health 
and Human Services as described in paragraph (b)(1)(ii) of this section 
and does not have an objection as described in Sec.  147.132 to 
providing the contraceptive services identified in the self-
certification or the notification from the Department of Health and 
Human Services, the issuer will provide payments for contraceptive 
services as follows--
    (i) The issuer must expressly exclude contraceptive coverage from 
the group health insurance coverage provided in connection with the 
group health plan and provide separate payments for any contraceptive 
services required to be covered under Sec.  147.130(a)(1)(iv) for plan 
participants and beneficiaries for so long as they remain enrolled in 
the plan.
    (ii) With respect to payments for contraceptive services, the 
issuer may not impose any cost-sharing requirements (such as a 
copayment, coinsurance, or a deductible), premium, fee, or other 
charge, or any portion thereof, directly or indirectly, on the eligible 
organization, the group health plan, or plan participants or 
beneficiaries. The issuer must segregate premium revenue collected from 
the eligible organization from the monies used to provide payments for 
contraceptive services. The issuer must provide payments for 
contraceptive services in a manner that is consistent with the 
requirements under sections 2706, 2709, 2711, 2713, 2719, and 2799A-7 
of the PHS Act. If the group health plan of the eligible organization 
provides coverage for some but not all of any contraceptive services 
required to be covered under Sec.  147.130(a)(1)(iv), the issuer is 
required to provide payments only for those contraceptive services for 
which the group health plan does not provide coverage. However, the 
issuer may provide payments for all contraceptive services at the 
issuer's option.
    (3) A health insurance issuer may not require any documentation 
other than a copy of the self-certification from the eligible 
organization or the notification from the Department of Health and 
Human Services described in paragraph (b)(1)(ii) of this section.
    (c) Notice of availability of separate payments for contraceptive 
services--insured group health plans and student health insurance 
coverage. For each plan year to which the optional accommodation in 
paragraph (b) of this section is to apply, an issuer required to 
provide payments for contraceptive services pursuant to paragraph (b) 
of this section must provide to plan participants and beneficiaries 
written notice of the availability of separate payments for 
contraceptive services contemporaneous with (to the extent possible), 
but separate from, any application materials distributed in connection 
with enrollment (or re-enrollment) in group health coverage that is 
effective beginning on the first day of each applicable plan year. The 
notice must specify that the eligible organization does not administer 
or fund contraceptive benefits, but that the issuer provides separate 
payments for contraceptive services, and must provide contact 
information for questions and complaints. The following model language, 
or substantially similar language, may be used to satisfy the notice 
requirement of this paragraph (c): ``Your [employer/institution of 
higher education] has certified that your [group health plan/student 
health insurance coverage] qualifies for an accommodation with respect 
to the Federal requirement to cover contraceptive services for women, 
including all Food and Drug Administration-approved, cleared, or 
granted contraceptives, as prescribed by a health care provider, 
without cost sharing. This means that your [employer/institution of 
higher education] will not contract, arrange, pay, or refer for 
contraceptive coverage. Instead, [name of health insurance issuer] will 
provide separate payments for contraceptive services that you use, 
without cost sharing and at no other cost, for so long as you are 
enrolled in your [group health plan/student health insurance coverage]. 
Your [employer/institution of higher education] will not administer or 
fund these payments. If you have any questions about this notice, 
contact [contact information for health insurance issuer].''
    (d) Individual contraceptive arrangements for eligible individuals. 
(1) An eligible individual may elect an individual contraceptive 
arrangement under which a willing provider of contraceptive services 
furnishes the eligible individual with contraceptive services that a 
group health plan or health insurance issuer would have been required 
to cover pursuant to Sec.  147.130(a)(1)(iv), if not for the plan's or 
issuer's exempt status under Sec.  147.132(a). Under this individual 
contraceptive arrangement, the willing provider of contraceptive 
services must furnish contraceptive services (including items and 
services that are integral to the furnishing of the contraceptive 
services) to the eligible individual without imposing a fee or charge 
of any kind, directly or indirectly, on the eligible individual or any 
other entity for the cost of the items and services or any portion 
thereof, except that the provider of contraceptive services may seek 
payment from, and be reimbursed by, an issuer for the costs of 
providing the items and services through an adjustment to the issuer's 
federally-facilitated Exchange or State Exchange on the Federal 
platform user fees pursuant to Sec.  156.50(d) of this subchapter.
    (2) The following language may, but is not required to, be used by 
a participant, beneficiary, or enrollee (or an authorized 
representative of a participant, beneficiary, or enrollee) to confirm 
to a provider of contraceptive services that the plan or coverage is 
sponsored, provided, or arranged by an objecting entity and does not 
provide coverage for all or a subset of contraceptive services as 
generally required under Sec.  147.130(a)(1)(iv): ``I certify that I am 
enrolled (or am an authorized representative of a person who is 
enrolled) in an employer-sponsored health plan or individual health 
insurance coverage that does not provide coverage for all or a subset 
of contraceptive services as generally required under the Affordable 
Care Act.'' A participant, beneficiary, or enrollee (or an authorized 
representative of a participant, beneficiary, or enrollee) may use 
other means to confirm to a provider of contraceptive services that the 
plan or coverage is sponsored, provided, or arranged by an objecting 
entity and does not provide coverage for all or a subset of 
contraceptive services.
    (e) Reliance. (1) If an issuer reasonably and in good faith relies 
on a representation by an eligible organization indicating that the 
organization is eligible for the accommodation in paragraph (b) of this 
section, and the representation is later determined to be incorrect, 
the issuer is considered to comply with any applicable requirement 
under Sec.  147.130(a)(1)(iv) to provide contraceptive coverage if the 
issuer complies with the obligations under this section applicable to 
such issuer.
    (2) A group health plan is considered to comply with any applicable 
requirement under Sec.  147.130(a)(1)(iv) to provide contraceptive 
coverage if the plan complies with its obligations under paragraph (b) 
of this section, without regard to whether the issuer complies with the 
obligations under this section applicable to such issuer.

[[Page 7279]]

    (f) Rule of construction. In the case of student health insurance 
coverage, this section is applicable in the same manner as it is 
applicable to group health insurance coverage provided in connection 
with a group health plan established or maintained by a plan sponsor 
that is an employer, and references to ``plan participants and 
beneficiaries'' will be interpreted as references to student enrollees 
and their covered dependents.
    (g) Definitions. (1) For the purposes of this section, reference to 
``contraceptive'' services, benefits, or coverage includes 
contraceptive or sterilization items, procedures, or services, or 
related patient education or counseling, to the extent specified for 
purposes of Sec.  147.130(a)(1)(iv).
    (2) For the purposes of this section, the term ``provider of 
contraceptive services'' means any health care provider (including a 
clinician, pharmacy, or other facility) acting within the scope of that 
provider's license, certification, or authority under applicable law to 
provide contraceptive services (as defined in paragraph (g)(1) of this 
section).
    (h) Severability. Any provision of this section held to be invalid 
or unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this section and shall not affect the 
remainder thereof or the application of the provision to persons not 
similarly situated or to dissimilar circumstances.
0
10. Section 147.132 is amended by revising paragraphs (a)(1)(i) 
introductory text, (a)(1)(iv), and (b) to read as follows:


Sec.  147.132  Religious exemptions in connection with coverage of 
certain preventive health services.

    (a) * * *
    (1) * * *
    (i) A group health plan and health insurance coverage provided in 
connection with a group health plan, to the extent the non-governmental 
sponsor of the plan or coverage objects as specified in paragraph 
(a)(2) of this section. Such non-governmental plan sponsors include the 
following entities--
* * * * *
    (iv) A health insurance issuer offering group or individual health 
insurance coverage to the extent the issuer objects as specified in 
paragraph (a)(2) of this section. Where a health insurance issuer 
providing group health insurance coverage is exempt under this 
paragraph (a)(1)(iv), the group health plan established or maintained 
by the plan sponsor with which the health insurance issuer contracts 
remains subject to any requirement to provide coverage for 
contraceptive services under guidelines issued under Sec.  
147.130(a)(1)(iv) unless it is also exempt from that requirement. 
Notwithstanding Sec. Sec.  146.150 of this subchapter and 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 under paragraph (a) or (b) of 
this section, respectively.
* * * * *
    (b) Objecting individuals. (1) Guidelines issued under Sec.  
147.130(a)(1)(iv) by the Health Resources and Services Administration 
must not provide for or support the requirement of coverage or payments 
for contraceptive services with respect to an individual who objects to 
coverage or payments for some or all contraceptive services based on 
sincerely held religious beliefs. Thus, the following entities will be 
exempt from any Health Resources and Services Administration guidelines 
requirements that relate to the provision of contraceptive services 
with respect to such an individual:
    (i) A health insurance issuer offering group or individual health 
insurance coverage willing to provide the plan sponsor (with respect to 
the individual) or individual, as applicable, with a separate policy, 
certificate, or contract of insurance; or
    (ii) A group health plan willing to provide the individual a 
separate group health plan or benefit package option.
    (2) For purposes of this paragraph (b), if an individual objects to 
some but not all contraceptive services and the issuer, to the extent 
permitted by applicable State law, and the plan sponsor, as applicable, 
are 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.
* * * * *


Sec.  147.133  [Removed]

0
11. Section 147.133 is removed.

PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE 
CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES

0
12. The authority citation for part 156 continues to read as follows:

    Authority: 42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 
18044, 18054, 18061, 18063, 18071, 18082, and 26 U.S.C. 36B.

0
13. Section 156.50 is amended in paragraph (a) by adding the definition 
of ``provider of contraceptive services'' in alphabetical order and 
revising paragraph (d) to read as follows:


Sec.  156.50  Financial support.

    (a) * * *
    Provider of contraceptive services has the meaning given to the 
term in Sec.  147.131(g)(2) of this subchapter.
* * * * *
    (d) Adjustment of Exchange user fees. (1) A participating issuer 
offering a plan through a Federally-facilitated Exchange or State 
Exchange on the Federal platform may qualify for an adjustment of the 
federally-facilitated Exchange user fee specified in paragraph (c)(1) 
of this section or the State Exchange on the Federal platform user fee 
specified in paragraph (c)(2) of this section, to the extent that the 
participating issuer--
    (i) Made payments for contraceptive services on behalf of a third 
party administrator pursuant to 26 CFR 54.9815-2713A(b)(2)(ii) or 29 
CFR 2590.715-2713A(b)(2)(ii);
    (ii) Seeks an adjustment in the Federally-facilitated Exchange user 
fee or State Exchange on the Federal platform user fee with respect to 
a third party administrator that, following receipt of a copy of the 
self-certification referenced in 26 CFR 54.9815-2713A(a)(1)(iii) or 29 
CFR 2590.715-2713A(a)(1)(iii), made or arranged for payments for 
contraceptive services pursuant to 26 CFR 54.9815-2713A(b)(2)(i) or 
(ii) or 29 CFR 2590.715-2713A(b)(2)(i) or (ii); or
    (iii) Seeks an adjustment in the federally-facilitated Exchange 
user fee or State Exchange on the Federal platform user fee with 
respect to a provider of contraceptive services that, following receipt 
of a representation by or on behalf of an individual that the 
individual is an eligible individual (as defined in 26 CFR 54.9815-
2713A(a)(3), 29 CFR 2590.715-2713A(a)(3), or Sec.  147.131(a)(3) of 
this subchapter), furnished contraceptive services to the eligible 
individual, without imposing a fee or charge of any kind, directly or 
indirectly, on the eligible individual or any other entity for the cost 
of the items

[[Page 7280]]

and services or any portion thereof pursuant to 26 CFR 54.9815-
2713A(e), 29 CFR 2590.715-2713A(e), or Sec.  147.131(d) of this 
subchapter.
    (2) For a participating issuer described in paragraph (d)(1) of 
this section to receive an adjustment of a user fee under this 
section--
    (i) The participating issuer must submit to HHS, in the manner and 
timeframe specified by HHS, in the year immediately following the 
calendar year in which the contraceptive services for which payments 
pursuant to 26 CFR 54.9815-2713A(b)(2) or (e), 29 CFR 2590.715-
2713A(b)(2) or (e), or Sec.  147.131(d) of this subchapter were 
provided--
    (A) Identifying information for the participating issuer and each 
third party administrator that received a copy of the self-
certification referenced in 26 CFR 54.9815-2713A(a)(1)(iii) or 29 CFR 
2590.715-2713A(a)(1)(iii), whether or not the participating issuer was 
the entity that made the payments for contraceptive services, and each 
provider of contraceptive services that furnished contraceptive 
services in compliance with 26 CFR 54.9815-2713A(e), 29 CFR 2590.715-
2713A(e), or 45 CFR 147.131(d) to an eligible individual (as defined in 
26 CFR 54.9815-2713A(a)(3), 29 CFR 2590.715-2713A(a)(3), or Sec.  
147.131(a)(3) of this subchapter), with respect to which the 
participating issuer seeks an adjustment of the user fee specified in 
paragraph (c)(1) or (2) of this section, as applicable;
    (B) Identifying information for each self-insured group health plan 
with respect to which a copy of the self-certification referenced in 26 
CFR 54.9815-2713A(a)(1)(iii) or 29 CFR 2590.715-2713A(a)(1)(iii) was 
received by a third party administrator, and with respect to which the 
participating issuer seeks an adjustment of the user fee specified in 
paragraph (c)(1) or (2) of this section, as applicable;
    (C) For each such self-insured group health plan, the total dollar 
amount of the payments that were made pursuant to 26 CFR 54.9815-
2713A(b)(2) or 29 CFR 2590.715-2713A(b)(2) for contraceptive services 
that were provided during the applicable calendar year. If such 
payments were made by the participating issuer directly as described in 
paragraph (d)(1)(i) of this section, the total dollar amount should 
reflect the amount of the payments made by the participating issuer; if 
the third party administrator made or arranged for such payments, as 
described in paragraph (d)(1)(ii) of this section, the total dollar 
amount should reflect the amount reported to the participating issuer 
by the third party administrator;
    (D) Documentation, with respect to each provider of contraceptive 
services, demonstrating that the participating issuer and the provider 
of contraceptive services have a signed written agreement providing 
that the participating issuer will reimburse (or has reimbursed) the 
provider of contraceptive services for the costs of furnishing 
contraceptive services during the applicable calendar year in 
compliance with 26 CFR 54.9815-2713A(e), 29 CFR 2590.715-2713A(e), or 
Sec.  147.131(d) of this subchapter, and will seek an adjustment of the 
user fee specified in paragraph (c)(1) or (2) of this section as a 
result of the agreement to reimburse the provider's costs under 26 CFR 
54.9815-2713A(e), 29 CFR 2590.715-2713A(e), or Sec.  147.131(d) of this 
subchapter; and
    (E) For each provider of contraceptive services as specified in 
paragraph (d)(2)(i)(A) of this section, the total dollar amount of the 
costs of furnishing contraceptive services during the applicable 
calendar year pursuant to 26 CFR 54.9815-2713A(e), 29 CFR 2590.715-
2713A(e), or Sec.  147.131(d) of this subchapter.
    (ii) Each third party administrator that intends to seek an 
adjustment on behalf of a participating issuer of the Federally-
facilitated Exchange user fee or the State-based Exchange on the 
Federal platform user fee based on payments for contraceptive services, 
must submit to HHS a notification of such intent, in a manner specified 
by HHS, by the 60th calendar day following the date on which the third 
party administrator receives the applicable copy of the self-
certification referenced in 26 CFR 54.9815-2713A(a)(1)(iii) or 29 CFR 
2590.715-2713A(a)(1)(iii).
    (iii) Each third party administrator identified in paragraph 
(d)(2)(i)(A) of this section must submit to HHS, in the manner and 
timeframe specified by HHS, in the year following the calendar year in 
which the contraceptive services for which payments were made pursuant 
to 26 CFR 54.9815-2713A(b)(2) or 29 CFR 2590.715-2713A(b)(2) were 
provided--
    (A) Identifying information for the third party administrator and 
the participating issuer;
    (B) Identifying information for each self-insured group health plan 
with respect to which a copy of the self-certification referenced in 26 
CFR 54.9815-2713A(a)(1)(iii) or 29 CFR 2590.715-2713A(a)(1)(iii) was 
received by the third party administrator and with respect to which the 
participating issuer seeks an adjustment of the user fee specified in 
paragraph (c)(1) or (2) of this section, as applicable;
    (C) The total number of participants and beneficiaries in each such 
self-insured group health plan during the applicable calendar year; and
    (D) For each such self-insured group health plan with respect to 
which the third party administrator made payments pursuant to 26 CFR 
54.9815-2713A(b)(2) or 29 CFR 2590.715-2713A(b)(2) for contraceptive 
services, the total dollar amount of such payments that were provided 
during the applicable calendar year. If such payments were made by the 
participating issuer directly as described in paragraph (d)(1)(i) of 
this section, the total dollar amount should reflect the amount 
reported to the third party administrator by the participating issuer; 
if the third party administrator made or arranged for such payments, as 
described in paragraph (d)(1)(ii) of this section, the total dollar 
amount should reflect the amount of the payments made by or on behalf 
of the third party administrator.
    (E) An attestation that the payments for contraceptive services 
were made in compliance with 26 CFR 54.9815-2713A(b)(2) or 29 CFR 
2590.715-2713A(b)(2).
    (3) If the requirements set forth in paragraph (d)(2) of this 
section are met, the participating issuer will be provided a reduction 
in its obligation to pay the user fee specified in paragraph (c)(1) or 
(2) of this section, as applicable, equal in value to the sum of the 
following:
    (i) The total dollar amount of the payments for contraceptive 
services submitted by the applicable third party administrators, as 
described in paragraph (d)(2)(iii)(D) of this section;
    (ii) The total dollar amount of the costs of furnishing 
contraceptive services submitted by the participating issuer on behalf 
of applicable providers of contraceptive services, described in 
paragraph (d)(2)(i)(E) of this section; and
    (iii) An allowance for administrative costs and margin. The 
allowance will be no less than 10 percent of the total dollar amount of 
the payments for contraceptive services and the costs of furnishing 
contraceptive services specified in paragraphs (d)(3)(i) and (d)(3)(ii) 
of this section. Unless a new allowance is specified for an applicable 
year in the HHS notice of benefit and payment parameters or other 
rulemaking, HHS will maintain the allowance that was last specified in 
rulemaking.
    (4) If the amount of the adjustment under paragraph (d)(3) of this 
section is greater than the amount of the participating issuer's 
obligation to pay

[[Page 7281]]

the user fee specified in paragraph (c)(1) or (2) of this section, as 
applicable, in a particular month, the participating issuer will be 
provided a credit in succeeding months in the amount of the excess.
    (5) The participating issuer may reimburse each third party 
administrator and provider of contraceptive services for payments for 
contraceptive services submitted by the third party administrator or 
the provider of contraceptive services' costs of furnishing 
contraceptive services, as described in paragraphs (d)(2)(iii)(D) and 
(d)(2)(i)(E) of this section, as soon as the services are delivered. 
The participating issuer must pay, within 60 days of receipt of any 
adjustment of a user fee under this section, each third party 
administrator and provider of contraceptive services with respect to 
which it received any portion of such adjustment an amount that is no 
less than the portion of the adjustment attributable to the total 
dollar amount of the payments for services submitted by the third party 
administrator or the provider of contraceptive services' costs of 
furnishing contraceptive services, as described in paragraphs 
(d)(2)(iii)(D) and (d)(2)(i)(E) of this section. No payment to a third 
administrator or provider of contraceptive services is required with 
respect to the allowance for administrative costs and margin described 
in paragraph (d)(3)(iii) of this section. This paragraph does not apply 
if the participating issuer made the payments for contraceptive 
services on behalf of the third party administrator, as described in 
paragraph (d)(1)(i) of this section, or is in the same issuer group as 
the third party administrator.
    (6) A participating issuer that receives an adjustment in the user 
fee specified in paragraph (c)(1) or (2) of this section for a 
particular calendar year must maintain for 10 years following that 
year, and make available upon request to HHS, the Office of the 
Inspector General, the Comptroller General, and their designees, 
documentation demonstrating that it timely paid each third party 
administrator and provider with respect to which it received any such 
adjustment any amount required to be paid to the third party 
administrator or provider under paragraph (d)(5) of this section.
    (7) A third party administrator of a plan with respect to which an 
adjustment of the user fee specified in paragraph (c)(1) or (2) of this 
section is received under this section for a particular calendar year 
must maintain for 10 years following that year, and make available upon 
request to HHS, the Office of the Inspector General, the Comptroller 
General, and their designees, all of the following documentation:
    (i) A copy of the self-certification referenced in 26 CFR 54.9815-
2713A(a)(1)(iii) or 29 CFR 2590.715-2713A(a)(1)(iii) for each self-
insured plan with respect to which an adjustment is received.
    (ii) Documentation demonstrating that the payments for 
contraceptive services were made in compliance with 26 CFR 54.9815-
2713A(b)(2) or 29 CFR 2590.715-2713A(b)(2).
    (iii) Documentation supporting the total dollar amount of the 
payments for contraceptive services submitted by the third party 
administrator, as described in paragraph (d)(2)(iii)(D) of this 
section.
    (8) A provider of contraceptive services that has furnished 
contraceptive services in compliance with the individual contraceptive 
arrangement, with respect to which a participating issuer received an 
adjustment of the user fee specified in paragraph (c)(1) or (2) of this 
section for a particular calendar year must, as a condition of 
participating in the individual contraceptive arrangement, maintain for 
10 years following the contraceptive service being provided, and make 
available upon request to HHS, the Office of the Inspector General, the 
Comptroller General, and their designees, all of the following 
documentation:
    (i) Documentation demonstrating that the provider of contraceptive 
services furnished contraceptive services in compliance with 26 CFR 
54.9815-2713A(e), 29 CFR 2590.715-2713A(e), or Sec.  147.131(d) of this 
subchapter.
    (ii) Documentation supporting the total dollar amount of the costs 
of furnishing contraceptive services submitted by the provider of 
contraceptive services under paragraph (d)(2)(i)(E) of this section.
    (9) If a provider of contraceptive services relies reasonably and 
in good faith on a representation by or on behalf of an individual that 
the individual is an eligible individual (as defined in 26 CFR 54.9815-
2713A(a)(3), 29 CFR 2590.715-2713A(a)(3), or Sec.  147.131(a)(3) of 
this subchapter), and the representation is later determined to be 
incorrect, the provider of contraceptive services is considered to 
comply with the applicable requirements under paragraphs (d)(1)(iii), 
(d)(2)(i)(A), and (d)(8)(i) of this section.
    (10) If a participating issuer relies reasonably and in good faith 
on a representation by a provider of contraceptive services that the 
provider of contraceptive services furnished contraceptive services to 
an eligible individual (as defined in 26 CFR 54.9815-2713A(a)(3), 29 
CFR 2590.715-2713A(a)(3), or Sec.  147.131(a)(3) of this subchapter), 
without imposing a fee or charge of any kind, directly or indirectly, 
on the eligible individual or any other entity for the cost of the 
items and services or any portion thereof, and the representation that 
the provider of contraceptive services received from or on behalf of 
the individual is later determined to be incorrect, the participating 
issuer is considered to comply with the applicable requirements under 
paragraphs (d)(1)(iii) and (d)(2)(i)(A) of this section.
    (11) If a participating issuer relies reasonably and in good faith 
on a representation by a provider of contraceptive services that the 
provider of contraceptive services furnished contraceptive services to 
an eligible individual (as defined in 26 CFR 54.9815-2713A(a)(3), 29 
CFR 2590.715-2713A(a)(3), or Sec.  147.131(a)(3) of this subchapter), 
without imposing a fee or charge of any kind, directly or indirectly, 
on the eligible individual or any other entity for the cost of the 
items and services or any portion thereof, and the representation by 
the provider of contraceptive services is determined to be incorrect 
after the participating issuer has paid the provider of contraceptive 
services the amount described in (d)(2)(i)(E) of this section, the 
participating issuer is considered to comply with the applicable 
requirements under paragraphs (d)(1)(iii) and (d)(2)(i)(A) of this 
section.

Melanie R. Krause,
Acting Deputy Commissioner for Services and Enforcement, Internal 
Revenue Service.
Lisa M. Gomez,
Assistant Secretary, Employee Benefits Security Administration, 
Department of Labor.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-01981 Filed 1-30-23; 11:15 am]
BILLING CODE 4150-28-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.