# Safeguarding the Rights of Conscience as Protected by Federal Statutes > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2024-00091 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** January 11, 2024 - **Citation:** 89 FR 2078 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 88 RIN 0945-AA18 Safeguarding the Rights of Conscience as Protected by Federal Statutes AGENCY: Office for Civil Rights (OCR), Office of the Secretary, HHS. ACTION: Final rule SUMMARY: The Department of Health and Human Services (HHS or the Department) is issuing this final rule to partially rescind the May 21, 2019, final rule entitled, “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority” (“2019 Final Rule”), while leaving in effect the framework created by the February 23, 2011, final rule entitled, “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws” (“2011 Final Rule”), which has been in effect continuously since March 25, 2011. Though the 2019 Final Rule never took effect, the Department also retains, with some modifications, certain provisions of the 2019 Final Rule regarding federal conscience protections, but eliminates others that are redundant or confusing, that undermine the clarity of the statutes Congress enacted to both safeguard conscience rights and protect access to health care, or because significant questions have been raised as to their legality. DATES: This rule is effective March 11, 2024. FOR FURTHER INFORMATION CONTACT: Office for Civil Rights: David Christensen, Supervisory Policy Advisor, and Gabriela Weigel, Policy Advisor, HHS Office for Civil Rights, (202) 795-7830 or (800) 537-7697 (TDD), or via email at consciencerule@hhs.gov. Assistance to Individuals with Disabilities in Reviewing the Rulemaking Record: Upon request, the Department will provide an accommodation or auxiliary aid to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for the final rule. To schedule an appointment for this type of accommodation or auxiliary aid, please call (202) 795-7830 or (800) 537-7697 (TDD) for assistance or email consciencerule@hhs.gov. SUPPLEMENTARY INFORMATION: Electronic Access This Federal Register document is also available from the Federal Register online database through http://www.govinfo.gov, a service of the U.S. Government Publishing Office. Table of Contents Contents I. Background 900 A. Statutory Background 900 B. Regulatory Background 907 C. Litigation 910 D. The Proposed Rule 911 II. Comments on the Proposed Rule 913 A. General Comments 914 B. Comments Addressing Sections 88.1-88.4 of the Proposed Rule 916 C. Comments Addressing the Proposed Rule's Requests for Comment 941 III. Statutory Authority 971 IV. Overview and Section-by-Section Description of the Final Rule 972 V. Regulatory Impact Analysis 975 A. Introduction 975 B. Requests for Comment 976 C. Detailed Economic Analysis 981 D. Summary of Impacts 989 E. Regulatory Flexibility Analysis 990 Rule Text 993 I. Background A. Statutory Background Several provisions of Federal law protect the conscience rights of certain federally funded health care entities and prohibit recipients of certain Federal funds from requiring individuals and entities to participate in actions they find religiously or morally objectionable. They include the following provisions: The Church Amendments [42 U.S.C. 300a-7] The conscience provisions contained in 42 U.S.C. 300a-7 (collectively known as the “Church Amendments”) were enacted in the 1970s in response to debates over whether receipt of Federal funds required those recipients to perform abortion or sterilization procedures. The Church Amendments consist of five conscience provisions. The first provision, 42 U.S.C. 300a-7(b), provides that “[t]he receipt of any grant, contract, loan, or loan guarantee under [certain statutes implemented by the Department of Health and Human Services] by any individual or entity does not authorize any court or any public official or other public authority to require” (1) the individual to perform or assist in a sterilization procedure or an abortion, if it would be contrary to their religious beliefs or moral convictions; (2) the entity to make its facilities available for sterilization procedures or abortions, if the performance of sterilization procedures or abortions in the facilities is prohibited by the entity on the basis of religious beliefs or moral convictions; or (3) the entity to provide personnel for the performance or assistance in the performance of sterilization procedures or abortions, if it would be contrary to the religious beliefs or moral convictions of such personnel. The second provision, 42 U.S.C. 300a-7(c)(1), prohibits any entity that receives a grant, contract, loan, or loan guarantee under certain Department-implemented statutes from discriminating against any physician or other health care personnel in employment, promotion, termination of employment, or the extension of staff or other privileges because the individual “performed or assisted in the performance of a lawful sterilization procedure or abortion, 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, or because of his religious beliefs or moral convictions respecting sterilization procedures or abortions.” The third provision, 42 U.S.C. 300a-7(c)(2), prohibits any entity that receives a grant or contract for biomedical or behavioral research under any program administered by the Department from discriminating against any physician or other health care personnel in employment, promotion, termination of employment, or extension of staff or other privileges “because he performed or assisted in the performance of any lawful health service or research activity, because he refused to perform or assist in the performance of any such service or activity on the grounds that his performance or assistance in the performance of such service or activity would be contrary to his religious beliefs or moral convictions, or because of his religious beliefs or moral convictions respecting any such service or activity.” The fourth provision, 42 U.S.C. 300a-7(d), provides that “[n]o individual shall be required to perform or assist in the performance of any part of a health service program or research activity funded in whole or in part under a program administered by [the Department] if his performance or assistance in the performance of such part of such program or activity would be contrary to his religious beliefs or moral convictions.” The fifth provision, 42 U.S.C. 300a-7(e), prohibits any entity that receives a grant, contract, loan, loan guarantee, or interest subsidy under certain Departmentally implemented statutes from denying admission to, or otherwise discriminating against “any applicant (including applicants for internships and residencies) for training or study because of the applicant's reluctance, or willingness, to counsel, suggest, recommend, assist, or in any way participate in the performance of abortions or sterilizations contrary to or consistent with the applicant's religious beliefs or moral convictions.” Public Health Service Act Sec. 245, The Coats-Snowe Amendment [42 U.S.C. 238n] Enacted in 1996, section 245 of the Public Health Service Act (PHS Act) prohibits the Federal Government and any State or local governments receiving Federal financial assistance from discriminating against any health care entity on the basis that the entity (1) “refuses to undergo training in the performance of induced abortions, to require or provide such training, to perform such abortions, or to provide referrals for such training or such abortions;” (2) refuses to make arrangements for such activities; or (3) “attends (or attended) a post-graduate physician training program, or any other program of training in the health professions, that does not (or did not) perform induced abortions or require, provide, or refer for training in the performance of induced abortions, or make arrangements for the provision of such training.” For the purposes of this protection, the statute defines “financial assistance” as including “with respect to a government program,” “governmental payments provided as reimbursement for carrying out health-related activities.” In addition, PHS Act Sec. 245 requires that, in determining whether to grant legal status to a health care entity (including a State's determination of whether to issue a license or certificate), the federal government and any State or local governments receiving Federal financial assistance shall deem accredited any post-graduate physician training program that would be accredited, but for the reliance on an accrediting standard that, regardless of whether such standard provides exceptions or exemptions, requires an entity: (1) to perform induced abortions; or (2) to require, provide, or refer for training in the performance of induced abortions, or make arrangements for such training. Medicaid and Medicare The Medicaid and Medicare statutes also include certain conscience provisions. The Balanced Budget Act of 1997, Public Law 105-33, 111 Stat. 251 (1997), provides that Medicaid managed care-managed organizations and Medicare Advantage plans are not required to provide, reimburse for, or cover a counseling or referral service if the organization or plan objects to the service on moral or religious grounds. See id. 40011852(j)(3)(B), 111 Stat. at 295 (codified at 42 U.S.C. 1395w-22(j)(3)(B)) (Medicare Advantage); id. § 4704(b)(3)(B), 111 Stat. at 496-97 (codified at 42 U.S.C. 1396u-2(b)(3)(B)) (Medicaid). The organization or plan must, however, provide sufficient notice of its moral or religious objections to prospective enrollees. 42 U.S.C. 1395w-22(j)(3)(B)(ii) (Medicare Advantage), 1396u-2(b)(3)(B)(ii) (Medicaid managed care). These Medicare and Medicaid statutes also contain conscience provisions related to the performance of advanced directives. See 42 U.S.C. 1395cc(f), 1396a(w)(3), and 14406(2). Additionally, they contain provisions related to religious nonmedical health care providers and their patients. See 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395x(e), 1395x(y)(1), 1396a(a) and 1397j-1(b). For example, Congress prohibited States from excluding Religious Nonmedical Health Care Institutions (RNHCIs) from licensure through implementation of State definitions of “nursing home” and “nursing home administrator,” 42 U.S.C. 1396g(e), and Congress exempted RNHCIs from certain Medicaid requirements for medical criteria and standards. 42 U.S.C. 1396a(a) (exempting RNHCIs from 42 U.S.C. 1396a(a)(9)(A), 1396a(a)(31), 1396a(a)(33), and 1396b(i)(4)). Additionally, section 6703(a) of the Elder Justice Act of 2009 (Pub. L. 111-148, 124 Stat. 119) provides that Elder Justice and Social Services Block Grant programs may not interfere with or abridge an elder person's “right to practice his or her religion through reliance on prayer alone for healing,” when the preference for such reliance is contemporaneously expressed, previously set forth in a living will or similar document, or unambiguously deduced from such person's life history. 42 U.S.C. 1397j-1(b). The Weldon Amendment The Weldon Amendment, originally adopted as section 508(d) of the Labor-HHS Division (Division F) of the 2005 Consolidated Appropriations Act, Public Law 108-447, 118 Stat. 2809, 3163 (Dec. 8, 2004), has been readopted (or incorporated) in each subsequent legislative measure appropriating funds to HHS. See, e.g., Consolidated Appropriations Act, 2023, Public Law 117-328, div. H, title V General Provisions, section 507(d)(1) (Dec 29, 2022). The Weldon Amendment provides that “[n]one of the funds made available in this Act [making appropriations for the Departments of Labor, Health and Human Services, and Education] may be made available to a Federal agency or program, or to a State or local government, if such agency, program, or government subjects any institutional or individual health care entity to discrimination on the basis that the health care entity does not provide, pay for, provide coverage of, or refer for abortions.” It also defines “health care entity” to include “an individual physician or other health care professional, a hospital, a provider-sponsored organization, a health maintenance organization, a health insurance plan, or any other kind of health care facility, organization, or plan.” The Affordable Care Act Passed in 2010, the Patient Protection and Affordable Care Act (ACA), Public Law 111-148, 124 Stat. 119 (2010) (codified at 42 U.S.C. 18001, et seq. ), includes certain conscience provisions in sections 1553, 1303(b)(1)(A), (b)(4), and (c)(2)(A), and 1411(b)(5)(A). Section 1553 prohibits the Federal government, any state or local government, and any health care provider that receives Federal funding under the ACA, or any health plan created under the ACA, from subjecting an individual or health care entity to discrimination on the ground that the individual or entity does not provide services for the purpose of causing or assisting in the death of any individual, including through assisted suicide, euthanasia, and mercy killing. See 42 U.S.C. 18113(a). Section 1553 provides that the Department's Office for Civil Rights (“OCR”) will receive complaints of discrimination related to that section. Id. 18113(d). Section 1303(b)(1)(A) provides that issuers of qualified health plans shall determine whether or not the plan provides coverage of abortion services. Id. 18023(b)(1)(A)(ii). Additionally, Section 1303(b)(4) states that “[n]o qualified health plan offered through an Exchange may discriminate against any health care provider or health care facility because of its unwillingness to provide, pay for, provide coverage of, or refer for abortions.” Id. 18023(b)(4). Additionally, Section 1303(c) states that nothing in the ACA will be understood to preempt or otherwise effect State laws “regarding the prohibition of (or requirement of) coverage, funding, or procedural requirements on abortions, including parental notification or consent for the performance of an abortion on a minor,” 42 U.S.C. 18023(c)(1). Section 1303(c) also states that nothing in the ACA will be understood to have any effect on Federal laws that protect conscience; that regard the willingness or refusal to provide abortion; and that regard “discrimination on the basis of the willingness or refusal to provide, pay for, cover, or refer for abortion or to provide or participate in training to provide abortion.” Id. 18023(c)(2). Section 1303(d) further states that “Nothing in this Act shall be construed to relieve any health care provider from providing emergency services as required by State or Federal law,” including the Emergency Medical Treatment and Labor Act. Id. 18023(d). Section 1411(b)(5)(A) addresses exemptions to the ACA's “individual responsibility requirement.” 42 U.S.C. 18081(b)(5)(A). 1 Under this section, the Department may grant exemptions based on hardship (which the Department has stated includes an individual's inability to secure affordable coverage that does not provide for abortions (84 FR 23172), membership in a particular religious organization, or membership in a “health care sharing ministry”). 1 In 2017 Congress effectively eliminated the penalty for noncompliance by reducing it to zero. See Tax Cuts and Jobs Act of 2017, Public Law 115-97, 11081, 131 Stat. 2092 (codified in 26 U.S.C. 5000A(c)). Federal Conscience and Anti-Discrimination Protections Applying to Global Health Programs The Department administers certain programs under the President's Emergency Plan for AIDS Relief (PEPFAR), to which additional conscience protections apply. Specifically, recipients of foreign assistance funds for HIV/AIDS prevention, treatment, or care authorized by section 104A of the Foreign Assistance Act of 1961 (22 U.S.C. 2151b-2), 22 U.S.C. 7601-7682, or under any amendment made by the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (Pub. L. 110-293), cannot be required, as a condition of receiving such funds, (1) to “endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS,” or (2) to “endorse, utilize, make a referral to, become integrated with, or otherwise participate in any program or activity to which the organization has a religious or moral objection.” 22 U.S.C. 7631(d)(1)(B). The government cannot discriminate against such recipients in the solicitation or issuance of grants, contracts, or cooperative agreements for the recipients' refusal to do any such actions. 22 U.S.C. 7631(d)(2). In addition, recipients of foreign assistance funds under the Foreign Assistance Act of 1961 are prohibited from using those funds for performance or research respecting abortions or involuntary sterilization or to motivate or coerce any person to practice abortions or to coerce or provide any financial incentive to any person to undergo sterilization. 22 U.S.C. 2151b(f). Exemptions From Compulsory Medical Screening, Examination, Diagnosis, or Treatment Additional provisions relating to conscience have also been the subject of previous HHS rulemaking. These include provisions related to mental health treatment, hearing screening programs, vaccination programs, occupational illness testing, and compulsory health care services generally. First, under the Public Health Service Act, certain suicide prevention programs are not to be construed to require “suicide assessment, early intervention, or treatment services for youth” if their parents or legal guardians have religious or moral objections to such services. 42 U.S.C. 290bb-36(f); section 3(c) of the Garrett Lee Smith Memorial Act (Pub. L. 108-355, 118 Stat. 1404, reauthorized by Pub. L. 114-255 at sec. 9008). Second, authority to issue certain grants through the Health Resources and Services Administration (HRSA), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) may not be construed to preempt or prohibit State laws which do not require hearing loss screening for newborn, infants or young children whose parents object to such screening based on religious beliefs. 42 U.S.C. 280g-1(d). Third, in providing pediatric vaccines funded by Federal medical assistance programs, providers must comply with any State laws relating to any religious or other exemptions. 42 U.S.C. 1396s(c)(2)(B)(ii). Fourth, the provisions of the Occupational Safety and Health Act of 1970 are not to be construed to “authorize or require medical examination, immunization, or treatment for those who object thereto on religious grounds, except where such is necessary for the protection of the health or safety of others.” 29 U.S.C. 669(a)(5). Fifth, certain State and local child abuse prevention and treatment programs funded by HHS are not to be construed as creating a Federal requirement that a parent or legal guardian provide a child any medical service or treatment against the religious beliefs of that parent or legal guardian, 42 U.S.C. 5106i(a), and Medicaid and CHIP programs are not to be construed to require a State to compel a person to undergo medical screenings, examination, diagnosis, treatment, health care or services if a person objects on religious grounds, with limited exceptions, 42 U.S.C. 1396(f). Additionally, the Child Abuse Prevention and Treatment Act (CAPTA) specifies that it does not require (though it also does not prevent) a State finding of child abuse or neglect in cases in which a parent or legal guardian relies solely or partially upon spiritual means rather than medical treatment, in accordance with religious beliefs. 42 U.S.C. 5106i(a)(2). B. Regulatory Background No statute requires the promulgation of rules to implement the conscience provisions outlined above. On August 26, 2008, however, the Department exercised its discretion and issued a proposed rule entitled “Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law” (73 FR 50274) (2008 Final Rule) to address the conscience provisions in effect at that time. In the preamble to the 2008 Final Rule, the Department concluded that regulations were necessary in order to: 1. Educate the public and health care providers on the obligations imposed, and protections afforded, by Federal law; 2. Work with state and local governments and other recipients of funds from the Department to ensure compliance with the nondiscrimination requirements embodied in the Federal health care provider conscience protection statutes; 3. When such compliance efforts prove unsuccessful, enforce these nondiscrimination laws through the various Department mechanisms, to ensure that Department funds do not support coercive or discriminatory practices, or policies in violation of Federal law; and 4. Otherwise take an active role in promoting open communication within the health care industry, and between providers and patients, fostering a more inclusive, tolerant environment in the health care industry than may currently exist. “Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law,” 73 FR 78072, 78074. The rule went into effect on January 20, 2009, except for a certification requirement that never took effect, as it was subject to the information collection approval process under the Paperwork Reduction Act, which was never completed. On March 10, 2009, the Department proposed rescinding, in its entirety, the 2008 Final Rule, and sought public comment to determine whether or not to rescind the 2008 Final Rule in part or in its entirety (74 FR 10207). On February 23, 2011, the Department issued a final rule entitled “Regulation for the Enforcement of Federal Health Care Provider Conscience Protection Laws” (2011 Final Rule) (76 FR 9968). Concluding that parts of the 2008 Final Rule were unclear and potentially overbroad in scope, the 2011 Final Rule rescinded much of the 2008 Final Rule, including provisions defining certain terms used in one or more of the conscience provisions and requiring entities that received Department funds, both as recipients and subrecipients, to provide a written certificate of compliance with the 2008 Final Rule. The 2011 Final Rule retained a provision designating OCR to receive and coordinate the handling of complaints of violations of the three conscience provisions that were the subject of the 2008 Final Rule: the Church Amendments, the Weldon Amendment, and the Coats-Snowe Amendment. On January 26, 2018, the Department issued a new proposed rule entitled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority” (83 FR 3880) (2018 proposed rule). Citing a desire to “enhance the awareness and enforcement of Federal health care conscience and associated nondiscrimination laws, to further conscience and religious freedom, and to protect the rights of individuals and entities to abstain from certain activities related to health care services without discrimination or retaliation,” the 2018 proposed rule proposed reinstating several rescinded provisions of the 2008 Final Rule, while also expanding upon that rule in a number of respects. Among other things, the 2018 proposed rule added a number of additional statutes and a detailed provision that would apply to alleged violations of any of the statutes covered by the rule. In response to the 2018 proposed rule, the Department received over 242,000 comments from a wide variety of individuals and organizations, health care providers, faith-based organizations, patient advocacy groups, professional organizations, universities and research institutions, consumer organizations, and State and Federal agencies and representatives. Comments dealt with a range of issues surrounding the proposed rule, including the Department's authority to issue the rule, the need for the rule, what kinds of workers would be protected by the proposed rule, the rule's relationship to Title VII of the Civil Rights Act and other statutes and protections, what services are covered by the rule, whether the regulation might be used to discriminate against patients, how the rule would affect access to care, legal arguments, and the cost impacts and public health consequences of the rule. On May 21, 2019, the Department issued a final rule (84 FR 23170) (2019 Final Rule). The Department concluded that the withdrawal of the 2008 Final Rule had created confusion about the various conscience provisions, citing what the Department determined was a significant increase in complaints alleging violations of a conscience provision that it had received since November 2016. The Department consequently reinstated the 2008 Final Rule while revising and expanding on its provisions, including by (1) adding additional statutory provisions to the rule's enforcement scheme; (2) adopting definitions of various statutory terms; (3) imposing assurance and certification requirements; (4) reaffirming OCR's enforcement authority; (5) imposing record-keeping and cooperation requirements; (6) establishing enforcement provisions and penalties; and (7) adopting a voluntary notice provision. C. Litigation Following issuance of the 2019 Final Rule, a number of States, localities, and non-governmental parties filed lawsuits challenging the rule in the Southern District of New York, the Northern District of California, the Eastern District of Washington, and the District of Maryland. Before the rule took effect, the New York, California, and Washington district courts granted summary judgment to the respective plaintiffs and vacated the rule in its entirety nationwide. See Washington v. Azar, 426 F. Supp. 3d 704 (E.D. Wash. 2019), appeal pending, No. 20-35044 (9th Cir.); San Francisco v. Azar, 411 F. Supp. 3d 1001 (N.D. Cal. 2019), appeal pending, Nos. 20-15398 et al. (9th Cir.); New York v. HHS, 414 F. Supp. 3d 475 (S.D.N.Y. 2019), appeal dismissed without prejudice, Nos. 19-4254 et al. (2d Cir.). The courts' rationales for vacating the 2019 Final Rule were not identical, but each concluded that the rule was defective in a number of respects. One or more courts held that the 2019 Final Rule: (i) exceeded the Department's authority; (ii) was inconsistent in certain respects with the conscience statutes or other statutes, including the Emergency Medical Treatment & Labor Act (EMTALA) and Title VII of the Civil Rights Act; (iii) was arbitrary and capricious in its evaluation of the record, its treatment of the Department's conclusions underlying the 2011 Final Rule and reliance interests of funding recipients, and its consideration of certain issues relating to access to care and medical ethics raised by commenters; (iv) contained a particular definitional provision that was not promulgated in compliance with the notice-and-comment requirements of the Administrative Procedure Act (APA); and (v) had penalties for non-compliance with conscience provisions that violated the separation of powers and the Spending Clause. Because the 2019 Final Rule never took effect: (1) HHS has been continuously operating under the 2011 Final Rule; (2) HHS currently accepts, investigates, and processes complaints under the framework created by the 2011 Final Rule; (3) There are no significant reliance interests stemming from the 2019 Final Rule; (4) No person or entity could have therefore reasonably relied on the 2019 Final Rule's provisions; and (5) Health care providers or individuals have continuously and reasonably relied on the 2011 Final Rule because it has remained operational throughout. D. The Proposed Rule On January 5, 2023, the Department issued a notice of proposed rulemaking entitled, “Safeguarding the Rights of Conscience as Protected by Federal Statutes.” 88 FR 820 (2023 proposed rule). The Department proposed to partially rescind the 2019 Final Rule entitled “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority,” 84 FR 23170 (May 21, 2019) by: (1) leaving in effect the framework created by the 2011 Final Rule (76 FR 9968) and (2) retaining, with some modifications, certain provisions of the 2019 Final Rule. The Department solicited public comment to aid in its proposed rulemaking, specifically seeking comments addressing the following: 1. Information, including specific examples where feasible, addressing the scope and nature of the problems giving rise to the need for rulemaking, and whether those problems could be addressed by different regulations than those adopted in 2019 or by sub-regulatory guidance; 2. Information, including specific examples where feasible, supporting or refuting allegations that the 2019 Final Rule hindered, or would hinder, access to information and health care services, particularly sexual and reproductive health care and other preventive services; 3. Information, including specific examples where feasible, regarding complaints of discrimination on the basis that an individual or health care entity did not provide services for the purpose of causing or assisting in the death of any individual, including through assisted suicide, euthanasia, and mercy killing, as described in section 1553 of the ACA, and comments on whether additional regulations under this authority are necessary; 4. Information, including specific examples where feasible, regarding complaints of discrimination by a qualified health plan under the ACA on the basis that a health care provider or facility refused to provide, pay for, cover, or refer for abortions, as described in section 1303 of the ACA and comments on whether additional regulations under this authority are necessary; 5. Information, including specific examples where feasible, from health care providers regarding alleged violations of the conscience provisions provided for in the Medicaid and Medicare statutes, including the provisions codified at 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395w-22(j)(3), 1395x(e), 1395x(y)(1), 1395cc(f), 1396a(a), 1396a(w)(3), 1396u-2(b)(3), 1397j-1(b), and 14406(2) and comments on whether additional regulations under these authorities are necessary; 6. Information, including specific examples where feasible, regarding alleged violations of any of the other authorities that appeared in the 2019 Final Rule but not the 2011 Final Rule; 7. Comment on whether the 2019 Final Rule provided sufficient clarity to minimize the potential for harm resulting from any ambiguity and confusion that may exist because of the rule, and whether any statutory terms require additional clarification; 8. Comment on whether the provisions added by the 2019 Final Rule are necessary, collectively or with respect to individual provisions, to serve the statutes' or the rule's objectives, including with regard to whether the Department accurately evaluated the need for additional regulation in the 2019 Final Rule, and whether those provisions should be modified, or whether the rule's objectives may also be accomplished through alternative means, such as outreach and education; 9. Comment on the proposal to retain a voluntary notice provision, including comments on whether such notice should be mandatory, and what a model notice should include; and 10. Comment on the proposal to retain portions of the 2019 Final Rule's enforcement provisions in the proposed § 88.2. II. Comments on the Proposed Rule The Department received more than 48,000 comments addressing the 2023 proposed rule. A wide range of individuals and organizations submitted comments, including private citizens, health care workers and institutions, faith-based organizations, patient advocacy groups, civil rights organizations, professional associations, state and local government and elected officials, and members of Congress. These comments covered a variety of issues and points of view responding to the Department's requests for comments, and the Department reviewed and analyzed all of the comments. Most commenters supported the Department's proposed rule. The overwhelming majority of comments were individual comments associated with form letter campaigns from various groups and individuals. Numerous commenters, including civil rights organizations, health organizations, legal associations, and individual commenters, supported the proposed rule as written, while some commenters, including some faith-based organizations, supported the proposed rule as an improvement over the 2011 Final Rule. Some others supportive of the proposed rule, including certain legal associations, faith-based organizations, and individual commenters, requested the Department incorporate additional provisions from the 2019 Final Rule that were not at issue in the litigation over that rule. Still other commenters said they generally supported the proposal to rescind the 2019 Final Rule. Commenters also expressed opposition to the proposed rule for a variety of reasons. Numerous commenters, including some non-profits, legal organizations, faith-based organizations, and individuals opposed this rule because they would like the Department to retain the 2019 Final Rule. Other commenters, including a professional health care organization, a legal organization, and a local Department of Health, opposed the proposed rule on the grounds that they would like the Department to return to the 2011 Final Rule completely. Numerous commenters said they believed that the proposed rule would remove conscience protections, undermine the diversity of views in health care, and cause health care professionals to exit the profession. The Department thanks commenters for sharing their views on the proposed rule. Because the 2019 Final Rule never went into effect, the 2011 Final Rule has been in effect since its enactment. This final rule builds on the 2011 Final Rule and does not remove provisions from it. The Department therefore disagrees that employees would decide to leave the workforce in response to this final rule. The Department responds in greater detail in the following sections to comments requesting additions to the proposed rule text and other comments raising specific points of support for or opposition to this rule. This final rule responds to comments as follows. Subpart A addresses comments expressing concern over access to care; Subpart B addresses comments received on specific sections of the proposed rule; and Subpart C addresses comments in response to the Department's requests for comments in the proposed rule. A. General Comments Concerns Over Access to Care Comment: The Department received numerous comments that raised concerns over access to health care generally. For example, commenters, including reproductive health organizations and major professional health care associations, discussed the negative impact that refusals of care have on people of certain genders, sexes, ages, or races, and individuals with disabilities. The commenters further explained that these refusals exist against the backdrop of barriers many patients already face, especially among Black, Indigenous, and other people of color. These disparities are heightened for individuals living in rural areas, religious minorities, and people with disabilities. Some commenters said that conscience-based refusals to provide certain forms of health care block access to such care and endanger patient's lives. Many reproductive health organizations, individuals and other commenters, discussed the impact on reproductive health care after Dobbs vs. Jackson Women's Health Organization, 142 S. Ct. 2228 (2022), and the confusion for providers and patients that they contended that decision caused, especially in states that have banned, or attempted to ban, abortion. Commenters gave various examples of pregnant women being denied medical treatment for miscarriage management and sterilization procedures. Others were denied, or delayed in obtaining, medications, including emergency contraception. Many commenters, including reproductive health groups, reported that women were forced to wait extended periods or travel across state lines to obtain health care. Others said conscience-based refusals to provide certain kinds of care have negatively impacted the LGBTQI+ community, especially older LGBTQI+ adults. Many of these commenters also cited what they said were specific examples of such denials of care that constituted discrimination against LGBTQI+ individuals, including patients being shamed by doctors for taking pre-exposure prophylaxis (PrEP) medication; denials of gender-affirming care at hospitals; denials of emergency room care; refusals to provide prescription refills for gender dysphoria medication by pharmacists; and refusals of requests from persons with HIV to process lab specimens. Also, a professional health care organization urged the Department to ensure that its efforts to protect conscience not further reduce availability of abortion care, especially in areas where providers retain the ability under state law to provide those services. The organization recommended that while HHS permits individual providers to abide by their conscience, providers should do so in a way that is consistent with patients' immediate needs. Response: The Department thanks commenters for sharing this information. The Department is committed to protecting access to health care and protecting conscience rights as set forth in Federal statutes. 2 OCR works to advance access to health care by enforcing federal civil rights laws, the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, the Patient Safety Act and Rule, and Federal health care conscience statutes, which together protect fundamental rights of nondiscrimination, health information privacy, and conscience. The Federal health care conscience protection statutes represent Congress' attempt to strike a careful balance between maintaining access to health care on the one hand and honoring religious beliefs and moral convictions on the other. 3 Some doctors, nurses, and hospitals, for example, object for religious or moral reasons to providing or referring for abortions or assisted suicide, among other procedures. Respecting such objections honors liberty and human dignity. Patients also have rights and health needs, sometimes urgent ones. The Department will continue to respect the balance Congress struck, work to ensure individuals understand their conscience rights, and enforce the law. 2 See “Nondiscrimination in Health Programs and Activities,” 87 FR 47824 (Aug. 4, 2022). 3 See lengthier discussion of this principle on pages 40-41, below. B. Comments Addressing §§ 88.1-88.4 of the Proposed Rule 1. Comments Addressing § 88.1 General Support and Opposition Comment: Numerous commenters including some non-profit, legal, and faith-based organizations, supported the inclusion of the statutory authorities contained in § 88.1 of the 2019 Final Rule, and that are maintained in the proposed rule, because their inclusion provides clarity and awareness of the various conscience protections and ensures all federal conscience protections follow one clear and transparent process. Response: The Department appreciates the commenters' views. We will finalize and include in this final rule all the authorities providing for conscience protections that were contained in the 2019 Final Rule. Comment: Two reproductive health groups stated that the proposed rule properly relies on HHS's Housekeeping Authority under 5 U.S.C. 301 to create internal processes and guidelines “rather than impose substantial burdens on those regulated by the Church, Coats-Snowe, and Weldon Amendments, which HHS lacks the authority to do.” Another commenter argued that the Department's interpretation of the Federal conscience statutes is not entitled to deference given that “nothing in the Church, Coats-Snowe, and Weldon Amendments suggest that HHS is `charged with administering' them.” Other individual commenters noted that the 2019 Final Rule was justified under the Housekeeping Authority. Two commenters suggested that, in order to be consistent in noting the limited nature of the Housekeeping Authority for this rule, the Department must rescind other rules that exceed the bounds of that authority. Response: The Department thanks the commenters for their views on the scope of the Department's authority, including under the Housekeeping Authority. The Department agrees that it is authorized under its Housekeeping Authority, 5 U.S.C. 301, to establish internal processes for handling complaints raised under the conscience statutes. HHS is obligated to ensure compliance with these statutes because they apply to certain HHS programs and specific funding streams that HHS is expressly charged with administering. 4 Finally, whether any HHS rules outside of the context of the rulemakings for the Federal conscience statutes should be rescinded as beyond the Housekeeping Authority is beyond the scope of this rulemaking. 4 For example, 42 U.S.C. 300a-7(b) regards the receipt of Public Health Service Act funds which are administered by HHS agencies such as the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Healthcare Research and Quality (AHRQ), and the National Institutes of Health (NIH)); 42 U.S.C. 280g-1(d) regards funds for hearing screening which are awarded through the Health Resources and Services Administration (HRSA); 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3)(B) are rules of construction expressly applying to Medicare Advantage and Medicaid Managed Care Organizations which the Department oversees through the Centers for Medicare and Medicaid Services (CMS). Comment: Some commenters, including professional health care organizations and a local governmental entity, expressed opposition to the inclusion of statutes in the 2019 Final Rule that were not in the 2011 Final Rule. 5 The commenters argued: (1) HHS does not adequately justify why it is necessary to reference these statutes; (2) including these statutes will have negative consequences, such as undermining patients' access to medical care and information, imposing barriers to physicians' and health care institutions' ability to provide treatment, legitimizing discrimination against underserved and vulnerable patients, especially as regards abortion and gender-affirming care, and creating confusion and uncertainty among physicians, other health care professionals, and health care institutions about their legal and ethical obligations to treat patients; (3) HHS has not demonstrated that the public lacks awareness about these statutes; and (4) no influx of relevant complaints justifies the inclusion of the statutes. Another commenter noted that many of the conscience provisions have not been traditionally overseen by OCR, meaning they do not share the well-developed body of legal guidance applicable to civil rights complaints and it is therefore unclear which, if any, of the traditional safeguards for civil rights complainants, such as anti-retaliation protection, are available to complainants that refuse to engage in certain activities due to their religious or moral beliefs. Another commenter suggested HHS should not frame the statutes as conscience statutes and instead “accurately describe the scope of possible exemptions, including both religious and secular exemptions” or remove certain provisions from the rule. For example, 42 U.S.C. 18081 covers individuals seeking an exemption “as an Indian, or as an individual eligible for a hardship exemption”; 22 U.S.C. 7631 prevents aid from being provided with a condition that the recipient “endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS”; 29 U.S.C. 669 prevents that chapter from being “deemed to authorize or require medical examination.” 5 The statutes added by the 2019 Final Rule and retained in this final rule are: 42 U.S.C. 18113; 42 U.S.C. 14406(1)) 26 U.S.C. 5000A; 42 U.S.C. 18081; 42 U.S.C. 18023(b)(1)(A) and (b)(4); 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3)(B); 42 U.S.C. 1395cc(f), 1396a(w)(3), and 14406(2); 22 U.S.C. 7631(d); 22 U.S.C. 2151b(f), see, e.g., the Consolidated Appropriations Act, 2019, Public Law 116-6, Div. F, sec. 7018 (the “Helms, Biden, 1978, and 1985 Amendments”); 42 U.S.C. 1396f and 5106i(a); 42 U.S.C. 280g-1(d); 29 U.S.C. 669(a)(5); 42 U.S.C. 1396s(c)(2)(B)(ii); 42 U.S.C. 290bb-36(f); 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395x(e), 1395x(y)(1), 1396a(a), and 1397j-1(b)). 84 FR 23170, 23170 (May 2019). Response: The Department appreciates the concerns raised by commenters. First, the Department notes that this rule clarifies the Department's processes for handling the Federal health care conscience statutes. Second, the Department agrees that access to health care is a significant concern, especially for patients with urgent health care needs or marginalized populations whose care is facing restrictions across the country. As stated in the proposed rule, the Federal health care conscience protection statutes represent Congress' attempt to strike a careful balance. The Department is obligated to ensure compliance with the Federal conscience statutes set forth in this rule and is committed to doing so. At the same time, the Department, through OCR, also enforces civil rights laws that prohibit recipients of HHS federal financial assistance from discriminating on the basis of race, color, national origin, disability, age, sex, and religion in the provision of health care services. In addition to exhibiting the Department's commitment to patient access to care, this guidance is an example of OCR's role in coordinating compliance across various authorities. As explained in the proposed rule, retaining these provisions as part of the rule, and maintaining OCR as the centralized HHS office tasked with receiving and investigating complaints under these provisions, is consistent with OCR's existing role and delegations and will aid the public by: (1) increasing awareness of the rights protected by the various statutes, and (2) providing clear direction on where to file complaints alleging violations of those rights, even where the public is already aware of these authorities. Rather than requiring an affected party to determine which HHS component was responsible for the stream of funding connected to a potential problem, and how to raise their concerns, the rule creates a single intake point for anyone who believes their federally protected conscience rights may have been violated in the context of HHS programs. The Department disagrees that it should not retain the additional conscience statutes from the 2019 Final Rule in this final rule. In addition, the Department disagrees that 42 U.S.C. 18081, 22 U.S.C. 7631(d), and 29 U.S.C. 669(a)(5) are unrelated to conscience and do not belong in this rule. As with each of the other Federal health care conscience statutes, each of the provisions referenced by the commenter provides exemptions for or prohibits discrimination based on an individual or entity's religious or moral (or other) objection to a health care method or service. First, as noted in the proposed rule, 42 U.S.C. 18081(b)(5)(A) addresses exemptions to the ACA's “individual responsibility requirement.” 6 Under this section, the Department may grant exemptions based on hardship, which the Department has stated includes an individual's inability to secure affordable coverage that does not provide for abortions (84 FR 23172), membership in a particular religious organization, or membership in a “health care sharing ministry.” Second, the provisions at 22 U.S.C. 7631(d) state that a faith-based organization or other organization is not required in order to receive such assistance to “endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS;” or “endorse, utilize, make a referral to, become integrated with, or otherwise participate in any program or activity to which the organization has a religious or moral objection.” Finally, the relevant provision at 29 U.S.C. 669(a)(5) clarifies that nothing in that chapter will be deemed to “authorize or require medical examination, immunization, or treatment for those who object thereto on religious grounds.” The text of these statutes makes it clear that these provisions relate to protections for conscience, and so the Department declines to remove them from this rule. 6 In 2017 Congress effectively eliminated the penalty for noncompliance by being reducing it to zero. See Tax Cuts and Jobs Act of 2017, Public Law 115-97, 11081, 131 Stat. 2092 (codified in 26 U.S.C. 5000A(c)). Comment: Some commenters, including a health care organization, requested that the Department ensure the conscience statutes are properly enforced even in the context of enforcing other recent proposed HHS regulations, such as the Section 1557 notice of proposed rulemaking, 87 FR 47824, so that there is not an increase in instances where religious adherents are required to engage in conduct that violates their religious beliefs. These commenters suggested that the Department clarify how they planned to enforce the conscience statutes in light of these other regulations. Response: The final rule will maintain the general framework that OCR has been employing since 2011—enforcing the listed conscience statutes on a case-by-case basis, which respects the balance Congress sought to achieve through these statutes. The Section 1557 proposed rule is beyond the scope of this rulemaking. We note, however, that the proposed rule for Section 1557, for example, contains its own religious and conscience exemption process at proposed § 92.302 for how to raise such claims in the context of that rulemaking, 87 FR 47885-47886. Requests for Technical Changes Comment: Some commenters, including members of Congress, stated § 88.1's list of citations is incomplete without additional context like that provided in the 2019 Final Rule, making it harder for covered entities to have a full understanding of the implications of the law and how they will be applied and enforced. These commenters suggest that the rule “should include the full list of laws with their applicability, requirements, and prohibitions explained, as included in the 2019 rule at 88.3.” A commenter argued it would be unlawful for HHS not to retain language from § 88.1 of the 2019 Final Rule, given this rule's purpose of protecting conscience rights and preventing non-discrimination. Response: The Department thanks the commenters for their views. We have added explanatory text to the preamble of this final rule to elaborate on the full list of the laws included in this final rule. However, we are finalizing this rule without the additional information drawn from § 88.3 of the 2019 Final Rule because, in the Department's view, that explanatory language is not necessary to accomplish the goal of this section, namely clarifying which conscience statutes OCR enforces. We have added the full list of the laws covered by this final rule in the model notice. Additionally, the Department maintains information about the Federal conscience statutes on OCR's website, and has included a link to this web page in the model notice text in Appendix A of this final rule. 7 Moreover, a purpose provision similar to § 88.1 of the 2019 Final Rule is unnecessary given the procedural nature of this final rule. We note in this regard that the court in New York v. U.S. Dep't of Health & Human Servs., 414 F. Supp. 3d 475, 513-14, 523 (S.D.N.Y. 2019), cited language used in the purpose provision of § 88.1 of the 2019 Final Rule in support of its view that that rule was substantive. 7 See U.S. Dep't of Health and Human Servs., Off. for Civil Rights, Conscience and Religious Nondiscrimination, https://www.hhs.gov/conscience/conscience-protections/index.html. Comment: Two commenters requested that the Department correct an error in the preamble of the proposed rule that improperly paraphrased a provision of Section 1303 of the ACA, 42 U.S.C. 18023. The commenters pointed out that, when paraphrasing one provision of Section 1303 of the ACA, 42 U.S.C. 18023(c)(1), the language in the proposed rule did not mirror the language of the statute because the NPRM stated the provision discussed preemption of state laws about conscience, rather than lack of preemption of certain state laws about abortion. Response: OCR has made the noted corrections. Section 1303(c)(1) states that “Nothing in this Act shall be construed to preempt or otherwise have any effect on State laws regarding the prohibition of (or requirement of) coverage, funding, or procedural requirements on abortions, including parental notification or consent for the performance of an abortion on a minor.” 42 U.S.C. 18203(c)(1). The preamble of the final rule uses that language. Comment: A commenter suggested that § 88.1 should explicitly state that the Department's goal is to balance the interests of providers and patients. Another commenter argued that the freedom of conscience and religion should not be extended to facilities or institutions, such as hospital systems or universities, but only to individual providers. Response: The Department maintains that Congress sought to balance provider and patient rights through a variety of statutes and, as we noted in the proposed rule, the Department respects that balance. The Department declines to make changes to the final rule recommended by the commenter but discusses the issue of balancing these rights in greater detail in response to other comments infra at pages 42-43. Finally, regarding facilities or institutions, the Department will refer to each individual conscience statute in determining whether a particular statute applies to a particular entity. Comment: Noting that some of the statutory provisions do not apply to only health care providers, a commenter suggested changing the collective reference to the statutory authorities in § 88.1 and throughout the rule from “health care provider conscience protection statutes” to “health care conscience statutory protections.” Response: The Department agrees with the commenter's concern. For example, 42 U.S.C. 280g-1(d) protects parents of newborns, infants, and young children who object to hearing screenings based on religious beliefs. Likewise, 29 U.S.C. 669(a)(5) protects employees who object to “medical examination, immunization, or treatment . . . on religious grounds.” The Department will revise this provision in the final rule to refer to the statutes as the “Federal health care conscience protection statutes.” Comment: A commenter requested that reference be made to 42 U.S.C. 1395x(ss) within the reference to “certain Medicare and Medicaid provisions” in the list of statutory authorities in § 88.1. Response: OCR has been delegated multiple authorities that relate to protecting Religious Nonmedical Health Care Institutions (RNHCIs), five of which reference 42 U.S.C. 1395x(ss)(1), which defines RNHCIs. Section 1395x(ss)(1) contains the definition of RNHCIs, Section 1395x(ss)(2) covers accreditation of RNHCIs, and Section 1395x(ss)(3) contains a conscience provision that restricts the Secretary from requiring patients of RNHCIs to undergo certain medical services, such as medical screenings and treatment, against their religious beliefs, or from requiring RNHCIs and their personnel from undergoing medical supervision, regulation, or control, against their religious beliefs. Section 1395x(ss) was not delegated to OCR in the 2018 proposed rule's Delegations of Authority. 8 The Department declines to include 1395x(ss) in this final rule but is taking this comment under consideration outside this rulemaking process. 8 “Protecting Statutory Conscience Rights in Health Care; Delegations of Authority,” 83 FR 3880, 3901 (Jan. 26, 2018) 2. Comments Addressing § 88.2 Requests for Clarification Comment: Many commenters, including legal organizations and reproductive health groups, asked OCR to clarify that its enforcement authority is limited to existing provisions—such as those in the proposed rule and HHS's Uniform Administrative Requirements (UAR)—and clarify that it is not creating new mechanisms under this provision. Many commenters asked for clarification regarding the terms “relevant funding” and “appropriate action,” as well as the scope of the terms regarding violations of the proposed rule. Specifically, some commenters urged HHS to clarify that “appropriate action” relates to the enforcement tools of existing regulations (such as the UAR) and suggested establishing a limiting principle for “relevant funding” so that it cannot include all the funds available to an entity. One commenter expressed support for the proposed rule because they believed it removed the authority to initiate compliance reviews, make enforcement referrals to the Department of Justice, and claw back relevant funding. The commenter argued that these enforcement tools went beyond the existing regulations for enforcement that should be used when handling and investigating complaints. Another commenter indicated that in their view, proposed § 88.2(a)(4) in conjunction with proposed § 88.2(d) removes OCR's ability to undertake involuntary enforcement measures. The commenter approved of this perceived change and what they understood in the proposed rule to be a clarification that enforcement will be a voluntary process with flexibility for recipients to work with OCR to correct any findings of violations of the proposed rule. Other commenters asked the Department to modify the proposed rule to clarify that the scope of OCR's authority is limited to seeking voluntary resolution of complaints. Other commenters stated that the Department should not wait for a complaint in order to ensure compliance with the conscience statutes, and so should include the authority to initiate compliance reviews. Additional commenters argued that OCR should release formal findings of fact in any investigation before reconciliation is attempted and that the rule should state that complainants should be informed of other possible avenues for seeking relief when their complaint is resolved. Response: The Department thanks commenters for their views. As noted in the proposed rule, 45 FR 820, 825, the Department decided to retain certain provisions of the 2019 Final Rule with modifications and not to retain others in order to address various concerns, including concerns raised in litigation regarding the lawfulness of certain provisions of the 2019 Final Rule. The Department clarifies, however, that, where authorized by the funding at issue, OCR may initiate compliance reviews when it determines to do so in its enforcement discretion and may refer items to the Department of Justice for appropriate proceedings. Additionally, the provisions included under this rule maintain the authority to seek voluntary compliance. Specifically, the rule provides that matters of noncompliance will, when possible, be resolved using informal means. This does not preclude the Department from using relevant enforcement regulations, including, when necessary, formal means of achieving compliance. These existing enforcement regulations could include, for example, the Department's authority under the Uniform Administrative Requirements, Cost Principles, and Audit Requirements For HHS Awards (UAR; 45 CFR part 75). We also note that “relevant funding” as referenced in § 88.2(c) of the proposed rule is defined by the terms of the Federal conscience statutes. The Department makes several changes to the rule text to clarify its authority. The Department is adding reference to OCR's authority to initiate compliance reviews in § 88.2(a)(2) and a new § 88.2(c). The Department also notes OCR's authority in § 88.2(a)(7) to coordinate additional remedial action as the Department determines to be both necessary and allowed by applicable law and regulation. Additionally, the Department is adding a new paragraph (3) to proposed § 88.2(d), now § 88.2(g) in this final rule, to specify that where a matter is not able to be resolved by informal means, OCR will coordinate with the relevant Departmental component to (1) utilize enforcement regulations, such as those existing applicable to grants, contracts, or other programs and services, or (2) withhold funding as authorized and relevant under the statutes listed in § 88.1. Finally, the Department is also adding in § 88.2(a)(8) a reference to, and a new paragraph in § 88.2(g)(4) regarding, OCR's ability to refer enforcement items to the Department of Justice. Comment: Many commenters, including some non-profits, elected officials, and legal organizations, suggested that the provisions in proposed § 88.2 are not strong enough. Specifically, commenters were concerned that this rule does not include certain enforcement provisions from the 2019 Final Rule and were concerned with the statement that matters “will be resolved by informal means whenever possible.” Some asked the Department to define “informal means” and explain how that will deter future violations of the conscience statutes or prevent retaliation. One commenter stated that HHS should incorporate a formal resolution process in the rule in order to ensure conscience rights are not treated differently than other civil rights. Two commenters stated that the proposed rule was at risk of being unlawful because the Department failed to explain its rationale for not maintaining a formal resolution process similar to the 2019 Final Rule or because the rule was removing additional protections for conscience rights. Another commenter stated that the lack of effective and reasonable enforcement mechanisms would be an obstacle to ensuring compliance with the law. Several commenters stated that the proposed rule's removal of enforcement provisions from the 2019 Final Rule, including the requirement that HHS respond to and resolve conscience complaints, demonstrates clear anti-religious and anti-conscience bias and treats conscience rights as “less-than” or demonstrates “overt hostility on the part of the administration to both conscience rights and to religious liberty of health care professionals.” Many commenters raised the Department's investigation of the University of Vermont Medical Center, the California Department of Managed Health Care, and other recent decisions by the Department as examples of the need for additional provisions to ensure the final rule is adequate for consistently enforcing the Federal health care conscience statutes. Another commenter argued that the enforcement provisions retained in the proposed rule lacked an articulable standard against which any investigation will be conducted. The commenter stated that providers will be uncertain with respect to complaint investigations in this area, but that such uncertainty is preferable to over-regulating in the form of attempting to define violations without sufficiently stated guidance. Other commenters also claimed that the proposed rule will make it harder for any further discrimination claims to be filed, investigated, and remedied. Commenters made various additional requests, including for the rule to contain more rigorous enforcement protections, the explanatory provisions and enforcement mechanisms from the 2019 Final Rule, and clear protections against retaliation. Response: OCR works to achieve voluntary compliance with all the authorities it is delegated to enforce and has found this to be an effective means of ensuring compliance. This includes OCR's approach to enforcement of the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules, to the extent practicable and consistent with law, 9 and Title VI. 10 The Department's approach to the Federal conscience statutes is consistent with this approach. OCR further notes that applying a single “articulable standard,” as requested by a commenter, may not be appropriate given the breadth and variety of conscience statutes OCR is delegated to enforce. Rather than provide a one-size-fits-all standard, OCR will investigate complaints based on the relevant statute at issue. This rule clarifies that OCR is the central office to receive and handle complaints related to the conscience statutes and will coordinate complaints with partner agencies as appropriate on a case-by-case basis. This approach creates a more efficient and powerful method for ensuring compliance with the various statutes. 9 See 45 CFR 160.304. 10 See 28 CFR 42.411 (“Effective enforcement of title VI requires that agencies take prompt action to achieve voluntary compliance in all instances in which noncompliance is found.” (emphasis added)). Many of the other authorities OCR enforces, such as Title IX, Section 1557, Section 504, and the Age Discrimination Act, contain identical requirements. Further, the Department is making several additions to the rule text, similar to procedures contained in the 2019 Final Rule, in response to comments. As discussed in response to other comments, the Department is adding reference to OCR's authority to initiate compliance reviews in § 88.2(a) and a new § 88.2(c). The Department also notes OCR's authority in § 88.2(a)(7) to coordinate other remedial action as the Department deems appropriate and necessary and as allowed by law and applicable regulation. The Department is adding a new paragraph (3) to proposed § 88.2(d), now § 88.2(g) in this final rule, to specify that where a matter is not able to be resolved by informal means, OCR will coordinate and consult with the relevant Departmental component to either utilize enforcement regulations, such as those that existing applicable to grants, contracts, or other programs and services, or withhold funding as authorized and relevant under the statutes listed under § 88.1. Finally, the Department notes its authority in § 88.2(a)(8) to make enforcement referrals to the Department of Justice, and is adding a new paragraph (4) to proposed § 88.2(d), now § 88.2(g) in this final rule, to specify that OCR may, in coordination with the Office of the General Counsel, refer a matter that cannot be resolved informally to the Department of Justice to enforce the Federal health care conscience protection statutes as authorized by law. The Department takes seriously its obligations to comply with the Federal health care conscience protection statutes and has taken numerous actions to defend religious freedom rights, including by supporting the right to exercise faith freely. For example, the Department is participating in the National Strategy to Counter Anti-Semitism, including by providing ongoing OCR trainings on antidiscrimination laws, including the Federal health care conscience statutes, to medical students nationwide and holding listening sessions with chaplains on religious discrimination in healthcare settings. 11 As part of this same initiative, OCR recently released a bulletin on countering antisemitism which explains that, depending on the factual context, Title VI of the Civil Rights Act of 1964 and Section 1557 of the Affordable Care Act may prohibit discrimination against individuals who are or are perceived to be Jewish, Christian, Muslim, Sikh, Hindu, Buddhist, or of another religion, if the discrimination is based on their ancestry or ethnic characteristics. 12 Also, the Department, through the longstanding operation of the HHS Center for Faith-Based and Neighborhood Partnerships, continues efforts to build and support partnerships with faith-based and community organizations in order to better serve individuals, families and communities in need. 13 The Department's regulations state that faith-based organizations are eligible, on the same basis as any other organization, to participate in agency programs and services. 14 11 See Press Release, The White House, Fact Sheet: Biden-Harris Administration Releases First-Ever U.S. National Strategy to Counter Antisemitism (May 25, 2023), https://www.whitehouse.gov/briefing-room/statements-releases/2023/05/25/fact-sheet-biden-harris-administration-releases-first-ever-u-s-national-strategy-to-counter-antisemitism/. 12 See Bulletin, U.S. Dep't of Health and Human Servs., Off. for Civil Rights, Fact Sheet: Protecting Patients and Recipients of Human Services from Discrimination Based on Actual or Perceived Shared Ancestry or Ethnic Characteristics (Sept. 28, 2023), https://www.hhs.gov/civil-rights/for-individuals/special-topics/shared-ancestry-or-ethnic-characteristics-discrimination/index.html. 13 See Off. of Intergovernmental and External Affairs, Ctr. for Faith-based and Neighborhood Partnerships (Partnership Center) Homepage, (updated as of September 21, 2023), https://www.hhs.gov/about/agencies/iea/partnerships/index.html. 14 45 CFR part 87. Comment: One commenter requested that the Department specifically clarify OCR's process for handling complaints and the potential involvement of state health agencies as mentioned in proposed § 88.2(b). Other commenters requested OCR limit the extent to which OCR is permitted to rely on state agencies due to concerns about state laws and policies related to abortion and gender-affirming care potentially interfering with an accurate evaluation of the complaint under applicable federal law, especially where the state health departments involved have a record of hostility towards those seeking reproductive health care and gender-affirming care. They requested that OCR implement protections for the information gathered in the investigative process and clarify which state agencies may provide assistance, whether these agencies will make recommendations regarding resolution of the investigation, and when OCR will engage in independent fact finding. Another commenter suggested that HHS work to implement privacy protections ensuring state agencies cannot weaponize any collected information against any patients. Response: Where appropriate, OCR may coordinate the handling of complaints related to the Federal conscience statutes with State agencies. However, authority for making determinations about the Department's or another entity's compliance with the Federal conscience statutes as it relates to HHS programs and funding ultimately rests with the Department, which will consider all relevant facts and use its independent judgment in making its determination. Comment: Some commenters noted that the proposed rule does not obligate OCR to evaluate every complaint or assure the public of the prompt, transparent, thorough, and reasonable handling of complaints, which undercuts the effectiveness of the proposed rule. In addition, some commenters said the rule should be modified to “permit OCR to adopt a negative inference against an investigated entity for any factual question to which the entity fails to respond.” A couple of commenters questioned whether OCR was truly an independent factfinder without conflicts of interests and argued that more enforcement or compliance tools are needed to demonstrate independence. Response: The Department agrees with the commenters' recommendation on the prompt handling of complaints and has determined to retain, at proposed § 88.2(b), now § 88.2(d) of this final rule, text from § 88.7(d) of the 2019 Final Rule stating that “OCR shall make a prompt investigation” of conscience complaints. Additionally, OCR reviews all complaints it receives and takes into consideration a covered entity's response to questions and data requests to assess if a violation has taken place, or technical assistance can help the entity comply with the law. To clarify this, the Department is finalizing this final rule with the addition of a new § 88.2(e) that notes that, OCR may adopt a negative inference if, absent good cause, an entity that is subject to the Federal health care conscience protection statutes fails to respond to a request for information or to a data or document request within a reasonable timeframe. As noted in the proposed rule, the Department remains committed to educating patients, providers, and other covered entities about their rights and obligations under the conscience statutes and using its independent judgment to ensure compliance. Comment: One commenter recommended that to reduce confusion, the Department should use different forms to collect information on violations of the proposed rule than those used to collect civil rights complaints because conscience claims are legally distinct from civil rights complaints and will likely require different data and information during intake. Response: The Department thanks the commenter for their suggestion. However, OCR's intake forms are beyond the scope of this rulemaking. Comment: Some commenters requested that the rule state that complainants may be represented by legal counsel. Response: OCR's website states that a complaint may be filed on behalf of someone else. 15 We agree that legal counsel may file a complaint on behalf of their client and represent their client throughout the complaint investigation process. The Department is finalizing this final rule with the addition of a new § 88.2(b) which explains that any entity or individual may file a complaint with OCR alleging a potential violation of Federal health care conscience protection statutes, and the entity or individual filing does not have to be the entity or individual whose rights have been violated. 15 See, e.g., U.S. Dep't of Health and Human Servs., Off. for Civil Rights, Complaint Portal Assistant, https://ocrportal.hhs.gov/ocr/smartscreen/main.jsf. Interpretation of Federal Health Care Conscience Statutes Comment: Numerous commenters provided their views on the proper interpretation of the Federal health care conscience statutes with many requesting substantive guidance in the final rule on how OCR will interpret and apply the various statutes included in § 88.1. Two commenters stated that even if the Department lacks authority to issue substantive regulations interpreting any or all of the Federal health care conscience statutes, it cannot pretend that it will not engage in some interpretation of the meaning of those statutes in the course of its enforcement efforts. The commenters argued that therefore, the proposed rule should set out, for internal administrative purposes, and in at least general terms, principles governing how the Department will interpret the federal health care conscience statutes in relation to other laws. In the absence of definitions, the commenters argued that such a provision would provide some guidance to covered entities about how the Department understands the statutes subject to the proposed rule. Response: We appreciate these comments. The Department is committed to applying the relevant conscience statutes on a case-by-case basis, which respects the balance Congress sought to achieve through these statutes. 16 The Department appreciates the recommendation to issue additional guidance outside of this rulemaking and takes these comments under advisement, but it does not agree that there is a need for additional language as to the Department's interpretation of the statutes in this rule at this time given the Department's intended case-by-case approach to enforcing the conscience statutes. The Department consequently declines to add language interpreting the provisions of the conscience statutes to the rule text as it is unnecessary to include such information to clarify OCR's processes by which it enforces these statutes or to enforce the conscience statutes on a case-by-case basis. Additionally, this final rule encompasses a variety of statutes such that certain “general principles,” may not apply to all the statutes contained in this rulemaking. 16 See lengthier discussion of this principle on pages 40-41, below. Comment: Many commenters, including some faith-based organizations, legal organizations, and non-profits, stated the federal conscience rights should not be balanced against other competing interests and that HHS was not delegated authority to balance these interests, especially as against access to abortion. These commenters also expressed concern that a balancing test could result in different levels of protection for different providers based on factors like their geographic location or otherwise result in the arbitrary handling of conscience complaints. Another commenter said it was confusing to speak about a balance between the federal health care conscience statutes and other interests, as the proposed rule did, noting that the conscience statutes set forth absolute protections. The commenter went on to say that the courts that vacated the 2019 rule incorrectly held that the rule's broad construction of the federal health care statutes unlawfully displaced Title VII's application to employment-related religious exercise claims in the health care setting. Another commenter also emphasized that conscience statutes “are themselves a subset of nondiscrimination law.” At the same time, this commenter stressed that it agreed “that patients' autonomy and religious moral convictions must be respected” too. Response: As noted in the proposed rule, the Federal health care conscience protection statutes represent Congress' attempt to strike a careful balance between the rights of both providers and patients, and the Department intends to respect that balance. This statement reflects the balance Congress struck, not the legal requirements specific to each conscience statute set forth in this rule. Each of those conscience statutes contain particular legal requirements that must be met in order for them to apply to any given set of facts, and any determination regarding their application will be made based upon each statute. The Department wishes to affirm that conscience statutes are a subset of nondiscrimination law and to clarify that it understands that the text of the conscience statutes themselves generally does not contain balancing tests. At the same time, these statutes co-exist with others protecting rights of access to health care. As it did in the preamble to the 2011 final rule, the Department continues to affirm that health care entities must comply with the long-established requirements of statutes governing Departmental programs. These statutes strike a careful balance between the rights of patients to access needed health care, and the conscience rights of health care providers. Many of the conscience laws in this rule and the other federal statues have operated side by side, often for many decades. As the 2011 Final Rule stated, “repeals by implication are disfavored and laws are meant to be read in harmony.” The Department will continue to enforce all the laws it has been charged with administering. At the same time, entities must continue to comply with their Title X, Section 330, EMTALA, Medicaid obligations and the federal health care provider conscience protection statutes. 17 17 76 FR 9968, 9973-74 (2011). The Department will bear these points in mind in its investigation of any complaints it may receive. Comment: Many commenters, including professional health care associations and reproductive health groups, stated that the government should ensure that patients' access to care is a top priority and should be appropriately balanced with the needs of health care providers. Another commenter stated that it is important to ensure an exhaustive good faith effort is made to connect patients with care. Response: The Department thanks commenters for raising these concerns and agrees that patients' access to care is a top priority. Protecting the rights of conscience, as directed by Congress in federal statutes, is also a top priority, which the Department is committed to safeguarding as well. As noted elsewhere, the Department will handle complaints related to conscience on a case-by-case basis which respects the balance Congress sought to achieve through these statutes. Comment: One commenter requested that HHS focus its resources on civil rights complaints rather than conscience complaints because, compared to civil rights complaints, violations of conscience rights occur less frequently and rarely result in adverse medical outcomes for the provider. The commenter said that patients who encounter denial of care may be unable to find a suitable provider if they face a denial of care and may suffer adverse health consequences or death due to the denial. On the other hand, the commenter said providers seeking to deny care or that were prevented from denying care are unlikely to face the medical complications or death that can result from denial of care. Response: OCR reviews all the complaints it receives and will continue to do so for each of the authorities it is delegated to enforce. Comment: One commenter recommended that HHS include a provision that states no one served by HHS programs will be denied medically indicated care and impose a penalty for institutions and providers that deny necessary services under the “pretext” of religious freedom. The commenter noted, however, that HHS should restore the enforcement provisions from the 2019 Final Rule to avoid making providers feel they must choose between their religion and livelihood and facing retaliation. Response: The Department thanks the commenter for sharing its views. As discussed in response to other comments, the Department is adding provisions to this final rule similar to some of the enforcement provisions of the 2019 Final Rule. These include: reference to OCR's authority to initiate compliance reviews in § 88.2(a) and a new § 88.2(c); noting OCR's authority in § 88.2(a)(7) to “coordinate other appropriate remedial action as the Department deems necessary and as allowed by law and applicable regulation”; new paragraphs (3) and (4) to proposed § 88.2(d), now § 88.2(g) in this final rule, to specify formal means of enforcement, which may include the withholding of funds and referrals to the Department of Justice. Comment: One commenter recommended requiring that providers, grantees, and other entities subject to the proposed rule ensure patients are able to obtain care, including by being made aware of the treatments and procedures a provider refuses to provide, informed of alternative providers, and referred to alternative providers when failing to do so would harm the patient. Response: The Department agrees that patients should be able to make informed choices about which providers to seek care from, access care broadly, and receive the best care possible. This final rule clarifies OCR's existing authority and process for handling complaints under the conscience statutes. Adding a substantive provision in line with the commenter's request is beyond the scope of this rulemaking. The Department notes, however, that patients will also benefit from awareness of the Federal conscience statutes generated by entities posting a voluntary notice as outlined in this final rule. Comment: Several commenters, including professional health care organizations and a think tank, addressed the importance of having sufficient enforcement provisions in the proposed rule because courts have held that conscience statutes do not contain or imply a private right of action, meaning the government has the central role in enforcing Federal conscience laws and protecting providers from discrimination. Response: The Department agrees with commenters regarding the importance of the Department's role with respect to the Federal conscience statutes. As stated in the proposed rule, 45 FR 820, 826, the Department remains committed to educating patients, providers, and other covered entities about their rights and obligations under the conscience statutes and remains committed to ensuring compliance. As mentioned in response to other comments, this rule is being finalized with additional provisions from the 2019 Final Rule as well as all the authorities that the proposed rule previously incorporated from the 2019 Final Rule to allow for consistent and effective enforcement of the Federal conscience statutes. We believe that this rule simplifies, and therefore strengthens, the Department's approach to ensuring compliance with the underlying statutes. It provides clarity to providers and patients about where and how they may register their concerns. And it provides the Department the ability to apply the specific legal standards and enforcement mechanisms that correspond to the statute at issue. This, in turn, allows the Department to better achieve outcomes consistent with the statutory protections Congress enacted. We also note that in the proposed rule for Section 1557, the Department provided an additional process at proposed § 92.302 for individuals to raise requests for a conscience or religious freedom exemption, 87 FR 47885-47886. 3. Comments Addressing § 88.3 General Support Comment: Many commenters, including a national association of faith-based medical and dental providers and a national hospital association of faith-based providers, expressed support for the voluntary nature of the rule's notice provision. Additionally, a couple of commenters supported the proposed rule for allowing entities to tailor the voluntary notice to “particular circumstances and communities” and combine the notice with other notices. A couple of commenters also supported the proposed rule's inclusion of a recognition that some entities will have a conscience-based objection to posting details about alternative providers that offer services that the posting entity objects to providing. Commenters stated the proposed voluntary notice provision appropriately promotes compliance without undue burden. Response: The Department appreciates the commenters' support. The Department includes the voluntary notice provision, including the provision recognizing that some entities will have a conscience-based objection to posting details about alternative providers in the final rule. Requests for Changes to Rule Text Comment: A commenter argued that the proposed rule does not incentivize entities to post a voluntary notice. This commenter suggested that certain compliance requirements from § 88.6 of the 2019 Final Rule and the provision from §  88.5 of the 2019 Final Rule, which noted that posting the voluntary notice would constitute “non-dispositive evidence of compliance” and support the Department's goal of clarifying what an entity must do to comply with the federal conscience statutes. Response: As noted in the proposed rule, while the Department considers posting a notice to be a best practice and encourages covered entities to post the model notice included in this regulation, this alone does not satisfy the substantive obligations imposed on a covered entity by the underlying statutes. The proposed rule and this final rule modify §  88.5 of the 2019 Final Rule to avoid implying that covered entities can substantively comply with the underlying statute by simply posting a notice because such an implication could undermine the conscience protections provided by the underlying statutes themselves, and therefore the goal of this rule. While the Department does not adopt §  88.5 of the 2019 Final Rule, the Department is finalizing § 88.3 with additional statements that the Department considers posting a notice to be a best practice “towards achieving compliance with and educating the public about the Federal health care conscience statutes” and that “OCR will consider posting a notice as a factor in any investigation or compliance review” to emphasize the importance of posting the voluntary notice. The Department declines, however, to maintain all the compliance requirements from § 88.6 of the 2019 Final Rule. Some commenters raised concerns in response to both the 2018 Proposed Rule and the proposed rule for this rulemaking that the compliance requirements at § 88.6 were overly burdensome on covered entities, especially the record keeping requirements, and not authorized by the conscience statutes. In the Department's view, these concerns raised by commenters warrant additional consideration. Even though the Department declines to maintain the duty to cooperate as specified in § 88.6(c) of the 2019 Final Rule, however, this final rule includes a notice to covered entities in § 88.2(e) that OCR will adopt a negative inference if, absent good cause, an entity that is subject to the Federal health care conscience protection statutes fails to respond to a request for information or to a data or document request within a reasonable timeframe. In the Department's view, this requirement will encourage compliance without creating additional regulatory burden. Comment: One commenter requested that HHS require that notices related to conscience exceptions also be required to comply with the Section 1557 language access and auxiliary aids and services requirements. Response: The Department appreciates this comment. Covered entities are required to comply fully with all applicable language access requirements found in statute or regulation, regardless of whether the requirements overlap with the topics of this regulation. Language of the Notice Comment: Some commenters stated that the model notice should be the same as the model notice proposed in the 2019 Final Rule because it provided more clarity. Other commenters recommended more specific and clear language generally. A commenter said that, while they supported aspects of the proposed notice, such as listing the relevant statutes and dropping the implication that posting the notice would be some evidence of substantive compliance with the underlying statute, the commenter urged HHS to include in the notice a general description of the types of protections these statutes provide. Response: The Department appreciates the commenters' recommendations and has included the following text in the model notice text in response to commenter requests for more clarity: “You may have rights as a provider, patient, or other individual under these Federal statutes, which prohibit coercion or other discrimination on the basis of conscience in certain circumstances.” The Department also notes that § 88.3(d) states that an entity “may tailor its notice to address its particular circumstances and to more specifically address the conscience laws covered by this rule that apply to it.” Finally, the Department has included in the model notice a list of the federal health care conscience protection statutes and a link to the HHS web page where additional resources can be accessed for covered entities and the public to better understand their obligations and rights under the Federal health care conscience statutes. 18 18 See U.S. Dep't of Health and Human Servs., Off. for Civil Rights, Conscience and Religious Nondiscrimination, https://www.hhs.gov/conscience/conscience-protections/index.html. Comment: A commenter argued that the following language in proposed § 88.3(d) was improper: “where possible, and where the recipient does not have a conscience-based objection to doing so, the notice should include information about alternative providers that may offer patients services the recipient does not provide for reasons of conscience.” This commenter maintained that the language is improper because the Coats-Snowe Amendment prohibits a covered entity from requiring a physician or certain other individuals to refer patients, which may be the case where a covered employer does not object to the inclusion of information about alternative providers, but their employee physician does. Another commenter argued that this language was “a prudent observance of the Supreme Court's decision in NIFLA v. Becerra.” Response: The Department disagrees that the challenged language is improper. The provision identified by the commenter does not require recipients to provide information about alternative providers in any notice, nor does it suggest that any recipient may require a health care provider ( e.g., a doctor) to post this information in violation of their rights under applicable health care conscience protection statutes or the Constitution. Comment: A few commenters requested additional language in the voluntary notice that would focus on protecting patients from negative impacts caused by a denial of care under the conscience statutes. These commenters suggested that the voluntary notice provision has two target audiences: employees of providers and members of the public, and so there should be two separate notice provisions for each group, and they should be posted on the health care provider's website. Response: The Department agrees that patients should also be the focus of the voluntary notice and notes that the text of § 88.3 addresses this concern. Section 88.3(d) states that “[w]here possible, and where the recipient does not have a conscience-based objection to doing so, the notice should include information about alternative providers that may offer patients services the recipient does not provide for reasons of conscience,” which gives entities the opportunity to include additional information for the consideration of patients about access to certain health care services. Additionally, the Department in § 88.3(d) states that an entity “may tailor its notice to address its particular circumstances and to more specifically address the conscience laws covered by this rule that apply to it.” The Department is also adding text to the voluntary notice to make clear that the Federal health care conscience statutes also provide certain conscience protections for patients. Finally, the Department notes that § 88.3(b)(1) of both the proposed rule and this final rule recommends the model notice be posted on provider's websites, where both patients and providers may view it. 4. Comments Addressing Section 88.4 Comment: A commenter noted that the preamble to the proposed rule stated that it was repealing the severability provision, but that the provision is retained in the regulation text at § 88.4. Response: The Department thanks the commenter. The statement that OCR was removing the severability provision was a typographical error at 88 FR 820, 825. The error is corrected in this final rule. This rule provides meaningful tools for OCR to enforce the Federal health care conscience protection statutes. Section 88.4 ensures that portions of this rule not found to be unlawful would remain in effect even if a court were to strike down some provision of this final rule. The various complaint handling and investigating provisions at § 88.2, for instance, operate independently of each other. Likewise, the notice provision at § 88.3 can operate independently of the rest of the rule. C. Comments Addressing the Proposed Rule's Requests for Comment 1. Information, Including Specific Examples Where Feasible, Addressing the Scope and Nature of the Problems Giving Rise to the Need for Rulemaking, and Whether Those Problems Could Be Addressed by Different Regulations Than Those Adopted in 2019 or by Sub-Regulatory Guidance Comments Addressing the Scope and Nature of the Problems Giving Rise to the Need for Rulemaking Comment: In support of the need for rulemaking, one legal organization provided court cases related to the Religious Freedom Restoration Act. Another individual commenter cited her own published work which suggests that nurses and nursing students are under the impression that they must set aside their conscientious views to be a nurse. Other commenters highlighted that their religious beliefs and moral convictions are what motivate them to be in the health care field and help them to relate to the spiritual needs of patients who desire a religious perspective. Response: The Department appreciates the concerns raised by the commenters regarding the need for this rulemaking. While the Department does not opine here on any of the cases raised by the commenters, the comments help illustrate that finalizing this rule will provide further clarity about OCR's enforcement authority and processes related to the Federal health care conscience statutes. The Department is committed to applying the text of the relevant conscience statutes on a case-by-case basis, which respects the balance Congress sought to achieve through these statutes, and that commitment is evidenced in part through this new rulemaking. The Department has also taken steps to ensure that the public is aware of the protections under the conscience statutes beyond this rulemaking, including by issuing guidance on the Church Amendments. 19 The Department encourages anyone who believes the Federal health care conscience statutes have been violated to file a complaint with OCR. For detailed instructions on how to file a complaint or to download a complaint form, please visit OCR's website at www.hhs.gov/ocr/complaints. 19 U.S. Dep't of Health and Human Servs., Off. for Civil Rights, “Guidance on Nondiscrimination Protections under the Church Amendments” (Content last reviewed Feb. 3, 2023), https://www.hhs.gov/conscience/conscience-protections/guidance-church-amendments-protections/index.html. Whether the Problems Giving Rise to Rulemaking Could Be Addressed by Different Regulations or by Sub-Regulatory Guidance Comment: A commenter proposed a new framework for evaluating conscience complaints, revolving around requiring objections to be stated in advance, increasing staffing to accommodate objections, and requiring health care entities that object to providing procedures to either (1) facilitate and pay for transferring patients to hospitals that provide procedures or (2) limit their services to patients who share their beliefs and divest facilities where there is no similar sized health care entity within a 30 minute drive that provides all needed services. Another commenter similarly commented that any exceptions based on the Church Amendments should not apply if the provider's refusal to provide care results in serious harm to the patient, and the patient could not schedule another in-network provider. Response: The Department thanks the commenters. We decline to implement the commenters' recommendations in this final rule as they are beyond the scope of this rulemaking. The Department will adhere to the Federal health care conscience statutes and apply them on a case-by-case basis. Comment: Given the lack of explicit enforcement mechanisms in the existing statutes, one commenter urged the Department to consider what additional regulatory language or subsequent guidance it can provide consistent with its authority to ensure that the conscience laws are fully and effectively enforced when violations of conscience rights are found. Response: The Department thanks the commenter for recommending that the Department consider additional regulatory language and subsequent guidance. As discussed in response to other comments, the Department is adding regulatory language to clarify the Department's and OCR's authority to enforce the Federal health care conscience statutes, including through compliance reviews (§ 88.2(a) and a new § 88.2(c)), coordinating other appropriate remedial action (§ 88.2(a)), and OCR's authority to utilize existing enforcement regulations or withhold relevant funding to the extent authorized under the Federal health care conscience statutes where a matter cannot be resolved by informal means (§ 88.2(g)(3)). The commenter did not provide any recommendations on what that guidance should include, but the Department will continue to consider whether additional guidance under the conscience statutes is warranted. 2. Information, Including Specific Examples Where Feasible, Supporting or Refuting Allegations That the 2019 Final Rule Hindered, or Would Hinder, Access to Information and Health Care Services, Particularly Sexual and Reproductive Health Care and Other Preventive Services Comment: Some commenters, including reproductive health groups, claimed that the 2019 Final Rule generally would have had a negative effect on patients by restricting access to care and increasing denials of care. Commenters stated that barriers to health care are compounded in health systems that refuse to provide certain types of care due to religious or moral objections. These commenters said patients do not necessarily know about such limits on care. The commenters further said this occurs more often in rural areas where there are often no alternative providers, impacts those with lower incomes, and impacts pregnant women of color who disproportionately give birth at hospitals that object to abortion and contraception. Numerous commenters, including reproductive health groups and LGBTQI+ rights groups discussed the 2019 Final Rule's potential impact on services and access to care for groups of marginalized or underserved populations, including but not limited to women, older Americans, LGBTQI+ people, people with disabilities, people living in rural areas, Black, Indigenous, and people of color, immigrants, low-income communities, people with HIV, and people with substance use disorder. Numerous commenters discussed general health disparities and heightened discrimination against LGBTQI+ individuals, including access to reproductive health care and technology, that they claimed would have occurred because of the 2019 Final Rule. One commenter tied the fact that LGBTQI+ individuals already experience significant health inequities due to refusals to provide certain forms of care and stated LGBTQI+ individuals often suffer from “health care avoidance” due to facing discrimination in a number of services, including reproductive services, adoption and foster care services, childcare, homeless shelters, and transportation services—as well as physical and mental health care services. A commenter stated the 2019 Final Rule would have allowed providers to object to providing care, especially emergency services, which would disproportionately affect transgender people because of their struggle to access care. Another commenter argued the 2019 Final Rule would have harmed older adults by authorizing discrimination and increasing disparities in Medicare and Medicaid, especially for transgender older adults that would be at the mercy of Medicare Advantage plans hoping the plan contracts with providers who will not refuse them treatment. Additionally, a commenter discussed refusals to provide care that are based on religious or moral objections as particularly impactful to transgender individuals. Numerous commenters described the types of services that they believed the 2019 Final Rule would have negatively impacted, such as contraception, end-of-life care, vaccination, pregnancy and reproductive services, counseling and behavioral health, infertility treatment, pre-exposure prophylaxis (PrEP) and HIV treatment, among others. One commenter said the 2019 Final Rule could have allowed providers to refuse cancer treatment or reproductive services for pregnant individuals. Another commenter discussed the importance of family planning under the Title X program, stating that they believed the 2019 Final Rule would have reduced access to such “sexuality education” and family planning care and would have made it difficult for Title X facilities to hire employees willing to perform core job functions. Other commenters said that by further restricting access, the 2019 Final Rule would have exacerbated existing racial and socio-economic health disparities. A few commenters, including reproductive health organizations, noted that immigrants, ethnic minorities, and LGBTQI+ individuals faced disproportionate barriers accessing reproductive health care before the Dobbs v. Jackson Women's Health Organization, 142 S. Ct. 2228 (2022), decision and the 2019 Final Rule would have increased those barriers. One commenter stated that the 2019 Final Rule targeted people seeking reproductive health care, but even before the 2019 Final Rule, people cited religious beliefs to deny access to services such as abortion, sterilization, certain infertility treatments, and miscarriage management. A commenter stated there are serious physical and socioeconomical impacts on patients who experience discrimination when seeking abortion care, and refusals to provide such care can have profound health consequences for women. Two commenters stated that this partial recission of the 2019 Final Rule comes at an important time in the wake of the Dobbs decision, as abortion services are harder to obtain. Several commenters, including a reproductive health group, stated that the 2019 Final Rule upset the careful balance in Federal laws between patient needs and conscience rights, and that the proposed rule appropriately resets that balance. A professional health care association stated that in the balance between conscience rights and patients' rights, patients' rights must come first as the patient is in the more vulnerable position, meaning there is a duty to refer on the part of the objecting provider. A few commenters argued that the proposed rule is needed to ensure LGBTQI+ patients have access to care, free from discrimination. Two commenters stated that the proposed rule would minimize the frequency of refusals to provide abortions, which especially burden the most vulnerable in our society. The commenter also stated that physicians should have some discretion if they truly believe performing an abortion in certain cases would violate their duties as medical professionals, but those who would be unwilling to perform abortion under any circumstance are not well suited for reproductive health care. Numerous commenters, including a reproductive health organization, urged the Department to eliminate the 2019 Final Rule because it would have allowed almost any worker in a health care facility, insurance plan, or hospital to delay or block patients from getting care because of who they are or the kind of care they seek, including individuals indirectly involved in the provision of health care. One commenter stated that the 2019 Final Rule would have caused massive disruptions to large provider networks because costs of compliance with the 2019 Final Rule would have been astronomical, since losing federal funding for failure to comply would have led to the discontinuation of essential services and even closures. One commenter stated that the 2019 Final Rule failed to account for health care providers who have moral beliefs that motivate them to treat and provide health care, especially abortion, end-of-life care, and gender-affirming care, to patients. Response: The Department thanks commenters for sharing their views. The Department appreciates the concern that patients have full access to health care and as the proposed rule stated, 88 FR 820, 826, the Department maintains that our health care systems must effectively deliver services to all who need them in order to protect patients' health and dignity. The Department is engaging in this rulemaking in part to address the concerns raised by commenters about the impact of the 2019 Final Rule. The Department reiterates its commitment to ensuring that patients are not discriminated against, including by being denied health care on the various bases protected under civil rights laws. In addition, the Department is committed to ensuring compliance with the conscience statutes, including those provisions under the Church Amendments that offer protections for physicians or certain other individuals in certain federally funded health, training, or research programs who have performed or assisted in the performance of, or who are willing to perform or assist in the performance of, a lawful sterilization procedure or abortion. 3. Information, Including Specific Examples Where Feasible, Regarding Complaints of Discrimination on the Basis That an Individual or Health Care Entity Did Not Provide Services for the Purpose of Causing or Assisting in the Death of Any Individual, Including Through Assisted Suicide, Euthanasia, and Mercy Killing, as Described in Section 1553 of the ACA, and Comments on Whether Additional Regulations Under This Authority Are Necessary General Support for Conscience Protections Comment: Some commenters requested that conscience protections for assisted suicide be strengthened due to a recent rise in conscience objections. Some commenters referenced various examples, including cases and state laws from Vermont, Maine, California, and New Mexico and stated that since state laws protect conscience rights to a lesser degree than Section 1553, the Department must ensure compliance with Section 1553 to protect the conscience rights of those providers who object to taking human life. Response: The Department appreciates commenters providing their views regarding conscience rights related to assisted suicide. The Department remains committed to educating patients, providers, and other covered entities about their rights and obligations under the conscience statutes and remains committed to ensuring compliance, including with Section 1553 of the Affordable Care Act. Comment: A commenter noted that assisted suicide or medical aid in dying is not necessary, life-preserving, or lifesaving, so there should be no issue with permitting health care entities to refuse to perform such services for moral or religious objections. A commenter stated that conscientious objections are from the perspective of the objector, meaning it is immaterial how a state defines the “practice” of assisted suicide or whether it disagrees that abortion is a procedure that takes the life of a separate, unique, human being. Response: Each of the conscience statutes contains particular requirements that must be met in order for them to apply to a given set of facts. The Department remains committed to faithfully applying each statute as drafted by Congress on a case-by-case basis. Requests for Technical Changes Comment: One end-of-life patient advocacy group raised concerns about the proposed rule using the term “assisted suicide” as opposed to “medical aid in dying,” arguing that using that term in conjunction with citing Section 1553 of the Affordable Care Act would create barriers preventing terminally ill patients from accessing their right to “medical aid in dying” in states that authorize it and consider it as distinct from assisted suicide. The commenter argued that medical aid in dying is a medical procedure in which a physician writes a prescription for medication for a mentally capable, terminally ill adult who can then decide if they want to self-administer the medication if their suffering becomes too great. The commenter contrasted that with assisted suicide, which it defined as a criminal act in which someone encourages and facilitates the self-inflicted death of an individual irrespective of their life expectancy. The commenter recommended the Department use the term “medical aid in dying” to ensure that patients are informed of the option, and to distinguish between the duty to share information about medical options at the end of life from the act of participating in a medical procedure to which a provider objects. Response: The Department appreciates this comment. The Department notes that the final rule includes reference to Section 1553 of the Affordable Care Act, which uses the terms “assisted suicide,” “euthanasia,” and “mercy killing.” 20 The Department declines, however, to incorporate additional language in the rule text regarding the definition of “assisted suicide” or the other terms in the statute as it is unnecessary to include such language to clarify OCR's processes by which it enforces this statute or to enforce it on a case-by-case basis. 20 “The Federal Government, and any State or local government or health care provider that receives Federal financial assistance under this Act (or under an amendment made by this Act) or any health plan created under this Act (or under an amendment made by this Act), may not subject an individual or institutional health care entity to discrimination on the basis that the entity does not provide any health care item or service furnished for the purpose of causing, or for the purpose of assisting in causing, the death of any individual, such as by assisted suicide, euthanasia, or mercy killing.” 42 U.S.C. 18113(a). 4. Information, Including Specific Examples Where Feasible, Regarding Complaints of Discrimination by a Qualified Health Plan Under the ACA on the Basis That a Health Care Provider or Facility Refused To Provide, Pay for, Cover, or Refer for Abortions, as Described in Section 1303 of the ACA and Comments on Whether Additional Regulations Under This Authority Are Necessary Comment: The Department received a comment in response to this question, but did not receive information regarding complaints of discrimination by a qualified health plan. The commenter expressed concern that patients can either choose their employer's insurance plan or an Affordable Care Act plan but stated that neither type of insurance plan should be allowed to deny care under the federal conscience statutes. The commenter stated that health insurance plans, and hospitals as well, are not people with rights that can be infringed. Response: The Department thanks the commenters for sharing their views, but notes that each of the conscience statutes contains particular requirements and prohibitions that were put in place by Congress. Any determination regarding their application will be made based upon the specifics of each statute. 5. Information, Including Specific Examples Where Feasible, From Health Care Providers Regarding Alleged Violations of the Conscience Provisions Provided for in the Medicaid and Medicare Statutes, Including the Provisions Codified at 42 U.S.C. 1320a-1(h), 1320c-11, 1395i-5, 1395w-22(j)(3), 1395x(e), 1395x(y)(1), 1395cc(f), 1396a(a), 1396a(w)(3), 1396u-2(b)(3), 1397j-1(b), and 14406(2) and Comments on Whether Additional Regulations Under These Authorities Are Necessary Comment: A patient advocacy group generally discussed the importance of advance directives as a health care planning tool for end-of-life medical care. The commenter stated that the Medicare and Medicaid provisions regarding advanced directives should not be construed to allow entities and providers to fail to provide complete information to patients about end-of-life care and advance directives, pointing out that under many state laws providers may refuse to follow advance directives for religious or moral beliefs so long as the physician informs the patient and in many cases assists in the transfer to another provider who will honor the patient's wishes. Another commenter stated that the Department failed to articulate a sufficient reason for expanding the proposed rule to include these Medicare and Medicaid provisions. The commenter stated the proposed rule invalidates the inherent authority of advance directives by allowing providers to ignore these documents if they disagree. The commenter asserted that Section 1395cc(f) and CMS implementing regulations (See 42 CFR 489.102(a)(1)(ii) (2018); 42 CFR 418.52(a)(2) (2018)) require facilities to inform patients and residents of their rights to have completed advance directives, and that facilities should provide their patients and residents with written information about whether or not the provider objects on conscience grounds to honoring the directive. The commenter recommended that the Department require health care entities to provide accessible and prominent notice about all information the health care entity or provider refuses to offer and urged the Department to ensure patients are still timely transferred if a health care provider objects to honoring an advance directive. Response: As the proposed rule stated, retaining the Federal conscience provisions as a part of the rule and maintaining OCR as the centralized HHS office tasked with receiving and investigating complaints under these provisions will aid the public by increasing awareness of the rights protected by these statutes and where to file complaints alleging violations of those rights. The Department declines to include provisions beyond the text of the conscience statutes in this procedural rule as recommended by the commenter or to require entities to post information about services to which they have a conscience objection. The Department notes, however, that the voluntary notice provision of this final rule states that, where possible, and where the recipient does not have a conscience-based objection to doing so, the notice should include information about alternative providers that may offer patients services the recipient does not provide for reasons of conscience. Comment: One commenter referenced the Department's request for comment for examples from providers about discrimination in violation of conscience provisions in the Medicaid and Medicare statutes without directly providing such examples. The commenter stated that public and private insurance should safeguard existing benefits for children and should include reproductive health and related services. The commenter urged HHS to ensure no individuals receiving care through public health insurance are denied access to care or willing providers. Response: The Department thanks the commenter for sharing their concern. Providing such substantive provisions, however, is beyond the scope of this rulemaking. 6. Information, Including Specific Examples Where Feasible, Regarding Alleged Violations of Any of the Other Authorities That Appeared in the 2019 Final Rule But Not the 2011 Final Rule Comment: The Department only identified one comment in response to this question. A commenter offered suggestions on “other relevant authorities” (without citation) in reference to this request for comment and urged HHS to support only organizations that advocate in favor of childhood vaccination and not to make policy changes to weaken measures to immunize health care personnel. Response: The Department thanks the commenter for their response. This final rule clarifies OCR's existing authorities over the Federal conscience statutes in § 88.1, which includes a provision regarding pediatric vaccines (42 U.S.C. 1396s(c)(2)(B)(ii)). 7. Comment on Whether the 2019 Final Rule Provided Sufficient Clarity To Minimize the Potential for Harm Resulting From Any Ambiguity and Confusion That May Exist Because of the Rule, and Whether Any Statutory Terms Require Additional Clarification Whether the 2019 Final Rule Provided Sufficient Clarity To Minimize the Potential for Harm Comment: Numerous commenters, including reproductive health organizations and legal organizations, generally expressed support for the rescission of 2019 Final Rule provisions, stating that the 2019 Final Rule was confusing and redundant, unlawful, overbroad, discriminatory, and ripe for abuse. Many of these commenters also stated that rescinding the 2019 Final Rule would restore OCR's appropriate scope of enforcement. One commenter stated that the proposed rule reflected the appropriate balance between providing [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2024-00091. Public record. Not legal advice.