*This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display at or published in the Federal Register. This document may vary slightly from the published document if minor editorial changes are made during the OFR review process. The document published in the Federal Register is the official HHS-approved document. *Individuals using assistive technology may not be able to fully access information in this document. For assistance, please contact the Office for Civil Rights at (800) 368-1019 or (800) 537-7697 (TDD). 4153-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services 42 CFR Parts 438, 440, and 460 Office of the Secretary 45 CFR Parts 86, 92, 147, 155, and 156 RIN 0945-AA11 Nondiscrimination in Health and Health Education Programs or Activities, Delegation of Authority AGENCY: Centers for Medicare & Medicaid Services (CMS); Office for Civil Rights (OCR), Office of the Secretary, HHS. ACTION: Final rule. SUMMARY: The Department of Health and Human Services (“the Department” or “HHS”) is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). After considering public comments, in this final rule, the Department revises its Section 1557 regulations, Title IX regulations, and specific regulations of the Centers for Medicare & Medicaid Services (“CMS”) as proposed, with minor and primarily technical corrections. This will better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, *This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display at or published in the Federal Register. This document may vary slightly from the published document if minor editorial changes are made during the OFR review process. The document published in the Federal Register is the official HHS-approved document. *Individuals using assistive technology may not be able to fully access information in this document. For assistance, please contact the Office for Civil Rights at (800) 368-1019 or (800) 537-7697 (TDD). reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability. DATES: This rule is effective [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. FOR FURTHER INFORMATION CONTACT: Luben Montoya, Supervisory Civil Rights Analyst, HHS Office for Civil Rights, at (800) 368-1019 or (800) 537-7697 (TDD). SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose B. Summary of Major Provisions 1) Changes to the Section 1557 Regulation a. Elimination of Overbroad Provisions Related to Sex and Gender Identity b. Clarification of Scope of Covered Entities c. Elimination of Unnecessary or Duplicative Language on Civil Rights Enforcement d. Elimination of Unnecessary Regulatory Burdens e. Other Clarifications and Minor Modifications 2) Related and Conforming Amendments to Other Regulations a. Title IX b. CMS C. Summary of the Costs and Benefits of the Major Provisions II. Background III. Response to Public Comments on the Proposed Rule A. General Comments B. Section 1557 Regulation, Subpart A: General Requirements and Prohibitions 1) Proposed Repeal of Definitions in § 92.4 of the 2016 Rule 2 *This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display at or published in the Federal Register. This document may vary slightly from the published document if minor editorial changes are made during the OFR review process. The document published in the Federal Register is the official HHS-approved document. *Individuals using assistive technology may not be able to fully access information in this document. For assistance, please contact the Office for Civil Rights at (800) 368-1019 or (800) 537-7697 (TDD). 2) General Changes to 2016 Rule a. Purpose of Regulation, Revising § 92.1 of the 2016 Rule b. Effective Date c. Severability d. Summary of Regulatory Changes 3) Scope of Application in Proposed § 92.3; Repeal of § 92.208 a. Generally b. § 92.3(a): Covered Programs and Activities c. § 92.3(b): Scope of the Term “health program or activity” d. § 92.3(c) Health Insurance and Healthcare e. Summary of Regulatory Changes 4) Nondiscrimination Requirements in Proposed Revisions to § 92.2, and Repeal of § 92.8(d), 92.101, 92.206, 92.207, 92.209, and Appendix B of the 2016 Rule a. Discrimination on the Basis of Race, Color, or National Origin i. Generally ii. Repeal of Notice and Taglines Provisions at § 92.8(d) and Appendix B of the 2016 Rule b. Discrimination on the Basis of Disability c. Discrimination on the Basis of Age d. Discrimination on the Basis of Sex i. Generally ii. Gender Identity, including Single-Sex Services under § 92.206 of the 2016 Rule iii. Termination of Pregnancy iv. Sexual Orientation v. Scrutiny for Sex-Based Classifications (Repeal of § 92.101(b)(3)(iv) of the 2016 Rule) vi. Disparate Impact under § 92.101(b)(3)(iii) of the 2016 Rule vii. Insurance Coverage in § 92.207 of the 2016 Rule e. Discrimination on the Basis of Association, Repeal of § 92.209 of the 2016 Rule f. Multiple Protected Statuses g. Examples of Discriminatory Practices (Repeal of § 92.207 of the 2016 Rule) h. Summary of Regulatory Changes 3 *This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display at or published in the Federal Register. This document may vary slightly from the published document if minor editorial changes are made during the OFR review process. The document published in the Federal Register is the official HHS-approved document. *Individuals using assistive technology may not be able to fully access information in this document. For assistance, please contact the Office for Civil Rights at (800) 368-1019 or (800) 537-7697 (TDD). 5) Assurances in Proposed § 92.4, and Repeal of § 92.5 of the 2016 Rule 6) Enforcement Mechanisms in Proposed § 92.5, and Repeal of §§ 92.6, 92.7, 92.8, 92.101, 92.301, 92.302, 92.303, and Appendices A and C of the 2016 Rule a. Enforcement Procedures and Underlying Regulations in § 92.5(a) (Repeal of § 92.302 and § 92.6(a) of the 2016 Rule) b. Compensatory Damages (Repeal of § 92.301(b) of the 2016 Rule) c. Implied Private Rights of Action (Repeal of § 92.302(d) of the 2016 Rule) d. Voluntary Action (Repeal of § 92.302(c) and § 92.6(b) of the 2016 Rule) e. Access to Records of Compliance (Repeal of § 92.303(c) of the 2016 Rule) f. Prohibitions on Intimidation and Retaliation (Repeal of § 92.303(d) of the 2016 Rule) g. Perpetuating Discrimination by Assistance and Utilizing Criteria or Methods of Administration (Repeal of § 92.101(b)(1)(ii), (b)(3)(ii), and (b)(4)(ii) of the 2016 Rule) h. Notices of Nondiscrimination Rights and Statement of Nondiscrimination under the 2016 Rule (Repeal of § 92.8 of the 2016 Rule) i. Summary of Regulatory Changes 7) Relationship to Other Laws in Proposed § 92.6, and Repeal of § 92.2(b) and 92.3 of the 2016 Rule a. Conscience Laws b. Religious Freedom Restoration Act c. Title IX d. Other Laws and Cases e. Summary of Regulatory Changes C. Section 1557 Regulation, Subpart B: Specific Applications to Health Programs or Activities (Sections 92.201–92.205 of the 2016 Rule) 1) Meaningful Access for Individuals with Limited English Proficiency (45 CFR 92.101) 2) Effective communication for individuals with disabilities (45 CFR 92.102) 3) Accessibility standards for buildings and facilities (45 CFR 92.103) 4) Accessibility of information and communication technology (45 CFR 92.104) 5) Requirement to make reasonable modifications (45 CFR 92.105) 6) Summary of Regulatory Changes D. Title IX Regulations 4 *This HHS‐approved document is being submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display at or published in the Federal Register. This document may vary slightly from the published document if minor editorial changes are made during the OFR review process. The document published in the Federal Register is the official HHS-approved document. *Individuals using assistive technology may not be able to fully access information in this document. For assistance, please contact the Office for Civil Rights at (800) 368-1019 or (800) 537-7697 (TDD). 1) Nomenclature, Rules of Appearance, Effective Date Modifications to Rules at 45 CFR 86.31 and 86.71 2) Abortion Neutrality of 20 U.S.C. 1688 in 45 CFR 86.2 and 86.18 3) Summary of Regulatory Changes E. Conforming Amendments to CMS Regulations 1) Generally 2) Delivery of Medicaid Services (42 CFR 438.3(d)(4), 438.206(c)(2), 440.262)) 3) General Standards for Exchanges, QHPs for Exchanges, and Health Plan Issuers (45 CFR 155.120(c)(ii)),156.200(e)) 4) Guaranteed Coverage (45 CFR 147.104(e)) 5) Enrollment in QHPs through Exchanges By Agents or Brokers (45 CFR 155.220(j)(2)(i)) 6) Enrollment in QHPs and Exchanges By QHP Issuers (45 CFR 156.1230(b)(2)) 7) Summary of Regulatory Changes IV. Regulatory Impact Analysis A. Executive Orders 12866 and Related Executive Orders on Regulatory Review 1) Consideration of Regulatory Alternatives 2) Considerations for Cost-Effective Design 3) Methodology for Cost-Benefit Analysis 4) Cost-Benefit Analysis a.