Nondiscrimination in Health and Health Education Programs or Activities, Delegation of Authority

CourtCenters For Medicare And Medicaid Services
Citation85 FR 37160
Published date19 June 2020
Record Number2020-11758
Federal Register, Volume 85 Issue 119 (Friday, June 19, 2020)
[Federal Register Volume 85, Number 119 (Friday, June 19, 2020)]
                [Rules and Regulations]
                [Pages 37160-37248]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-11758]
                [[Page 37159]]
                Vol. 85
                Friday,
                No. 119
                June 19, 2020
                Part II
                Department of Health and Human Services
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                Centers for Medicare and Medicaid Services
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                42 CFR Parts 438, 440, and 460
                45 CFR Parts 86, 92, 147, et al.
                Nondiscrimination in Health and Health Education Programs or
                Activities, Delegation of Authority; Final Rule
                Federal Register / Vol. 85, No. 119 / Friday, June 19, 2020 / Rules
                and Regulations
                [[Page 37160]]
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                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, Department of Health and
                Human Services (HHS).
                ACTION: Final rule.
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                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,
                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 August 18, 2020.
                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 Sec. 92.4 of the 2016
                Rule
                 (2) General Changes to 2016 Rule
                 a. Purpose of Regulation, Revising Sec. 92.1 of the 2016 Rule
                 b. Effective Date
                 c. Severability
                 d. Summary of Regulatory Changes
                 (3) Scope of Application in Proposed Sec. 92.3; Repeal of Sec.
                92.208
                 a. Generally
                 b. Sec. 92.3(a): Covered Programs and Activities
                 c. Sec. 92.3(b): Scope of the Term ``Health Program or
                Activity''
                 d. Sec. 92.3(c) Health Insurance and Healthcare
                 e. Summary of Regulatory Changes
                 (4) Nondiscrimination Requirements in Proposed Revisions to
                Sec. 92.2, and Repeal of Sec. 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 Sec. 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 Sec.
                92.206 of the 2016 Rule
                 iii. Termination of Pregnancy
                 iv. Sexual Orientation
                 v. Scrutiny for Sex-Based Classifications (Repeal of Sec.
                92.101(b)(3)(iv) of the 2016 Rule)
                 vi. Disparate Impact Under Sec. 92.101(b)(3)(iii) of the 2016
                Rule
                 vii. Insurance Coverage in Sec. 92.207 of the 2016 Rule
                 e. Discrimination on the Basis of Association, Repeal of Sec.
                92.209 of the 2016 Rule
                 f. Multiple Protected Statuses
                 g. Examples of Discriminatory Practices (Repeal of Sec. 92.207
                of the 2016 Rule)
                 h. Summary of Regulatory Changes
                 (5) Assurances in Proposed Sec. 92.4, and Repeal of Sec. 92.5
                of the 2016 Rule
                 (6) Enforcement Mechanisms in Proposed Sec. 92.5, and Repeal of
                Sec. Sec. 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 Sec.
                92.5(a) (Repeal of Sec. 92.302 and Sec. 92.6(a) of the 2016 Rule)
                 b. Compensatory Damages (Repeal of Sec. 92.301(b) of the 2016
                Rule)
                 c. Implied Private Rights of Action (Repeal of Sec. 92.302(d)
                of the 2016 Rule)
                 d. Voluntary Action (Repeal of Sec. 92.302(c) and Sec. 92.6(b)
                of the 2016 Rule)
                 e. Access to Records of Compliance (Repeal of Sec. 92.303(c) of
                the 2016 Rule)
                 f. Prohibitions on Intimidation and Retaliation (Repeal of Sec.
                92.303(d) of the 2016 Rule)
                 g. Perpetuating Discrimination by Assistance and Utilizing
                Criteria or Methods of Administration (Repeal of Sec.
                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 Sec. 92.8 of the
                2016 Rule)
                 i. Summary of Regulatory Changes
                 (7) Relationship to Other Laws in Proposed Sec. 92.6, and
                Repeal of Sec. 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
                 (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
                [[Page 37161]]
                 (1) Consideration of Regulatory Alternatives
                 (2) Considerations for Cost-Effective Design
                 (3) Methodology for Cost-Benefit Analysis
                 (4) Cost-Benefit Analysis
                 a. Overview
                 b. Generally Applicable Benefits and Burdens
                 i. Simplification and Flexibility
                 ii. Policies and Procedures Concerning Gender Identity
                 c. Baseline Assumptions
                 d. Covered Entities
                 i. Entities Covered by Section 1557
                 (A) Entities With a Health Program or Activity, Any Part of
                Which Receives Federal Financial Assistance From the Department
                 (B) Programs or Activities Administered by the Department Under
                Title I of the ACA
                 (C) Entities Established Under Title I of ACA
                 ii. Entities Covered by Title IX
                 e. Cost Savings From Eliminating Notice and Taglines Requirement
                 f. Costs Arising From Removal of Notice and Taglines Requirement
                 g. Cost Savings From Changes to Language Access Plan Provisions
                 h. Cost Savings Attributed to Covered Entities' Handling of
                Certain Grievances
                 i. Additional Costs for Training and Familiarization
                 i. Number of Covered Entities That May Train Workers
                 ii. Number of Individuals Who Will Receive Training
                 iii. Total Costs of Training
                 j. Additional Costs for Revising Policies and Procedures
                 k. Other Benefits or Costs
                 (5) Impact on State, Local, and Tribal Entities under Executive
                Orders 12866, 13132, and 13175
                 a. State and Local Governments
                 b. Tribal Governments
                 (6) Avoidance of Inconsistent, Incompatible, or Duplicative
                Regulations
                 B. Executive Order 13771 on Reducing and Controlling Regulatory
                Costs
                 C. Congressional Review Act
                 D. Unfunded Mandates Reform Act
                 E. Regulatory Flexibility Act and Executive Order 13272 on
                Proper Consideration of Small Entities in Agency Rulemaking
                 F. Executive Order 12250 on Leadership and Coordination of
                Nondiscrimination Laws
                 G. Paperwork Reduction Act
                 (D) Delegation of Authority
                I. Executive Summary
                A. Purpose
                 This regulation finalizes the Department's proposed rule concerning
                Nondiscrimination in Health and Health Education Programs or Activities
                issued in the Federal Register on June 14, 2019 (84 FR 27846), with
                minor and primarily technical corrections. It makes changes to the
                Department's existing regulation \1\ (``2016 Rule'') implementing
                Section 1557 of the ACA, 42 U.S.C. 18116. It makes a related amendment
                to the Department's regulations implementing Title IX of the Education
                Amendments of 1972 (``Title IX''), and it makes conforming amendments
                to nondiscrimination provisions within various CMS regulations.
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                 \1\ 81 FR 31375-473 (May 18, 2016) codified at 45 CFR part 92.
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                 Through Section 1557 of the ACA, Congress applied certain long-
                standing civil rights nondiscrimination requirements to any health
                programs or activities that receive Federal financial assistance, and
                any programs or activities administered by an Executive agency under
                Title I of the ACA or by an entity established under such Title. It did
                so by cross-referencing statutes that specify prohibited grounds of
                discrimination, namely, race, color, national origin, sex, age, or
                disability, in an array of Federally funded and administered programs
                or activities. To ensure compliance, Congress dictated that ``[t]he
                enforcement mechanisms provided for and available under'' such laws
                ``shall apply for purposes of violations of'' Section 1557.\2\
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                 \2\ 42 U.S.C. 18116.
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                 This final rule returns to the enforcement mechanisms provided for,
                and available under, those longstanding statutes and the Department's
                implementing regulations. It eliminates many of the provisions of the
                2016 Rule in order to better comply with the mandates of Congress,
                relieves approximately $2.9 billion in undue regulatory burdens (over
                five years), furthers substantive compliance, reduces confusion, and
                clarifies the scope of Section 1557. It empowers the Department to
                continue its robust enforcement of civil rights laws by making clear
                that the substantive protections of Title VI of the Civil Rights Act of
                1964 (``Title VI''), Title IX, the Age Discrimination Act of 1975
                (``Age Act''), and Section 504 of the Rehabilitation Act of 1973
                (``Section 504'') remain in full force and effect.\3\
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                 \3\ While Section 1557 does not incorporate nondiscrimination
                provisions by reference to Title VII, it provides that nothing in
                Title I of the ACA is to be construed as invalidating or limiting
                the rights, remedies, procedures, or legal standards available under
                certain civil rights laws, and mentions Title VII specifically. 42
                U.S.C. 18116(b).
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                 This final rule is needed because the Department has determined
                that portions of the 2016 Rule are duplicative or confusing, impose
                substantial unanticipated burdens, or impose burdens that outweigh
                their anticipated benefits. Additionally, two Federal district courts
                have determined that the Department exceeded its authority in
                promulgating parts of the regulation, and one has vacated and remanded
                those parts of the 2016 Rule. By substantially repealing much of the
                2016 Rule, including removing the vacated provisions from the Code of
                Federal Regulations, the Department reverts to longstanding statutory
                interpretations that conform to the plain meaning of the underlying
                civil rights statutes and the United States Government's official
                position concerning those statutes.
                 The Department initially estimated the costs from the 2016 Rule at
                over $942 million across the first five years. 81 FR 31458-59. This
                figure, however, significantly underestimated actual costs, according
                to the Department's current estimates. As estimated now, the costs
                derived merely from the 2016 Rule's requirement to provide notices and
                taglines with all significant communications, after accounting for
                electronic delivery, amount to an average annual burden of $585 million
                per year, for a five-year burden of $2.9 billion. Based on the
                Department's re-examination of the burden on regulated entities, and
                after reviewing public comments, the Department has determined that the
                potential public benefits of imposing such requirements are outweighed
                by the large costs those requirements impose on regulated entities and
                other parties.
                B. Summary of Major Provisions
                (1) Changes to the Section 1557 Regulation
                a. Elimination of Overbroad Provisions Related to Sex and Gender
                Identity
                 This final rule eliminates certain provisions of the 2016 Rule that
                exceeded the scope of the authority delegated by Congress in Section
                1557. The 2016 Rule's definition of discrimination ``on the basis of
                sex'' encompassed discrimination on the basis of gender identity (``an
                individual's internal sense of gender, which may be male, female,
                neither, or a combination of male and female''). In line with that
                definition, the 2016 Rule imposed several requirements regarding
                medical treatment and coverage on the basis of gender identity. The
                same definition also encompassed discrimination on the basis of
                ``termination of pregnancy'' without incorporating the explicit
                abortion-neutrality language of 20 U.S.C. 1688 (which some commenters
                referred to as the Danforth Amendment) in Title IX, and it imposed a
                high burden of proof on providers to justify offering gynecological or
                other single-sex medical services.
                 All of these are essentially legislative changes that the
                Department lacked the
                [[Page 37162]]
                authority to make. They purported to impose additional legal
                requirements on covered entities that cannot be justified by the text
                of Title IX, and in fact are in conflict with express exemptions in
                Title IX, even though Title IX provides the only statutory basis for
                Section 1557's provision against discrimination ``on the basis of
                sex.'' For this reason, these provisions have already been vacated and
                remanded by court order. This final rule omits the vacated language
                concerning gender identity and termination of pregnancy, thereby
                bringing the provisions of the Code of Federal Regulations into
                compliance with the underlying statutes and up-to-date as to the effect
                of the court's order.
                 The Department also believes that various policy considerations
                support this action. The 2016 Rule's provisions on sex discrimination
                imposed new requirements for care related to gender identity and
                termination of pregnancy that Congress has never required, and
                prevented covered entities from drawing reasonable and/or medically
                indicated distinctions on the basis of sex. As a result, those
                provisions would have imposed confusing or contradictory demands on
                providers, interfered inappropriately with their medical judgment, and
                potentially burdened their consciences. By contrast, under this final
                rule, each State may balance for itself the various sensitive
                considerations relating to medical judgment and gender identity, within
                the limits of applicable Federal statutes (which are to be read
                according to their plain meaning).
                b. Clarification of Scope of Covered Entities
                 In an additional effort to avoid exceeding the Department's
                statutory authority, this final rule modifies the 2016 Rule's
                definition of entities covered by Section 1557 in order to align it
                more closely with the statutory text.
                c. Elimination of Unnecessary or Duplicative Language on Civil Rights
                Enforcement
                 This final rule also eliminates provisions of the 2016 Rule that,
                by unnecessarily duplicating or overlapping with existing civil rights
                law and regulations, were either inconsistent or redundant with
                existing law and regulations, and so were likely to cause confusion
                about the rights of individuals and the corresponding responsibilities
                of providers. This final rule prohibits any covered entity from
                discriminating on the basis of race, color, national origin, sex, age,
                and disability, according to the meaning of these terms in the
                underlying Federal civil rights statutes that Section 1557
                incorporates, and it commits the Department to enforcing these
                prohibitions through the enforcement mechanisms already available under
                those statutes' respective implementing regulations. It eliminates the
                2016 Rule's definitions of terms and its list of examples of
                discriminatory practices, as well as its provisions related to
                discrimination on the basis of association, disparate impact on the
                basis of sex, health insurance coverage, certain employee health
                benefits programs, notification of beneficiaries' rights under civil
                rights laws, designation of responsible employees and adoption of
                grievance procedures, access granted to OCR for review of covered
                entities' records of compliance, prohibitions on intimidation and
                retaliation, enforcement procedures, private rights of action, remedial
                action, and voluntary action. In all of these matters, this final rule
                will defer to the relevant existing regulations and the relevant case
                law with respect to each of the underlying civil rights statutes, as
                applied to the health context under Section 1557. It will not create,
                as the 2016 Rule did, a new patchwork regulatory framework unique to
                Section 1557 covered entities.
                d. Elimination of Unnecessary Regulatory Burdens
                 This final rule modifies provisions of the 2016 Rule that imposed
                regulatory burdens on covered entities greater than what was needed in
                order to ensure compliance with civil rights law. Specifically, it
                eliminates the burdensome requirement for covered entities to send
                notices and taglines with all significant communications, clarifies
                that the provision of health insurance, as such, is not a ``health
                program or activity,'' brings requirements of meaningful access for
                persons with limited English proficiency (LEP) into conformity with
                longstanding DOJ and HHS guidance, and permits remote English-language
                interpreting services to be audio-based rather than requiring them to
                be video-based.
                 The final rule retains numerous other provisions of the 2016 Rule
                that furthered the goal of civil rights compliance without imposing
                burdens unnecessary to that goal. These include the obligation for
                covered entities to submit assurances of compliance, as well as most of
                the 2016 Rule's provisions ensuring access for individuals with LEP and
                individuals with disabilities.
                e. Other Clarifications and Minor Modifications
                 This final rule modifies the 2016 Rule's discussion of its own
                relation to other laws, offering a clearer commitment to implement
                Section 1557 in conformity with the text of the statutes it
                incorporates, as well as with the text of numerous other applicable
                civil rights and conscience statutes. It also makes other minor
                modifications to the regulatory text.
                (2) Related and Conforming Amendments to Other Regulations
                a. Title IX
                 Because the Department's failure to incorporate the abortion
                neutrality language at 20 U.S.C. 1688 (hereinafter ``abortion
                neutrality'') and the Title IX religious exemption formed part of the
                Franciscan court's reasoning when it vacated parts of the 2016 Rule,
                this final rule amends the Department's Title IX regulations to
                explicitly incorporate relevant statutory exemptions from Title IX,
                including abortion neutrality and the religious exemption.
                b. CMS
                 Ten provisions in CMS regulations, all of which cover entities that
                are also subject to Section 1557, have in recent years had language
                inserted that prohibits discrimination on the basis of sexual
                orientation and gender identity. In light of this final rule's return
                to the plain meaning of ``on the basis of sex'' in the civil rights
                statutes incorporated under Section 1557, and the overarching
                applicability of Section 1557 to these programs, the Department here
                finalizes amendments to those regulations to ensure greater consistency
                in civil-rights enforcement across the Department's different programs
                by deleting the provisions on sexual orientation and gender identity.
                C. Summary of the Costs and Benefits of the Major Provisions
                 This final rule is an economically significant deregulatory action.
                The Department projects that this final rule will result in
                approximately $2.9 billion in cost savings (undiscounted) over the
                first five years after finalization. The Department anticipates that
                the largest proportion of these estimated savings would result from
                repealing the 2016 Rule's provisions related to mandatory notices. The
                Department projects additional savings from eliminating the requirement
                for OCR to weigh the presence or absence of language access plans, and
                from repealing provisions that duplicate existing regulatory
                requirements regarding the
                [[Page 37163]]
                establishment of grievance procedures. The Department estimates that
                there will be some additional costs to covered entities regarding
                training and revision of policies and procedures.
                 The Department believes that the anticipated benefits--which
                include consistency with Federal statutes, appropriate respect for the
                roles of Federal courts and Congress, and reduction or elimination of
                ineffective, unnecessary, or confusing provisions--far outweigh any
                costs or burdens that may arise from the changes.
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                 Provision(s) Savings and benefits Costs
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                Sec. 1557: Elimination of For provisions already vacated, eliminating them No costs are
                 Overbroad Provisions Related to brings the Code of Federal Regulations in line with anticipated for
                 Sex and Gender Identity. current law. For other provisions, eliminating them provisions already
                 restores the rule of law by confining regulation vacated, and any
                 within the scope of the Department's legal possible costs for
                 authority; restores Federalism by leaving to the related provisions are
                 States decisions properly reserved to them; and not calculable based
                 removes unjustified burdens on providers' medical on available data.
                 judgment.
                Sec. 1557: Clarification of Correcting this provision improves the rule of law by Costs are not
                 Scope of Covered Entities. interpreting the statute according to its plain calculable based on
                 meaning as closely as possible. available data.
                Sec. 1557: Elimination of Eliminating these provisions reduces duplication, The Department
                 Unnecessary or Duplicative inconsistency, and possible confusion in the estimates $275.8
                 Language on Civil Rights Department's civil rights regulations, making it million of costs in
                 Enforcement. easier for covered entities and individuals to know the first year for
                 their respective responsibilities and rights. revision of policies
                 and procedures, along
                 with corresponding
                 retraining of
                 employees. (These
                 costs encompass the
                 next listed set of
                 provisions as well.)
                Sec. 1557: Elimination of Eliminating these provisions reduces unnecessary, See above.
                 Unnecessary Regulatory Burdens. unjustified, or excessive burdens on health
                 providers, as well as excessive and confusing paper
                 notices for patients. This will make healthcare more
                 affordable and accessible for Americans and is
                 estimated to save $585 million per year over the
                 first five years.
                Sec. 1557: Other Clarifications Amending these provisions improves the rule of law by No costs are
                 and Minor Modifications. ensuring that regulations remain subject to anticipated, and any
                 statutory protections for conscience and other civil possible costs are not
                 rights, and otherwise contributes to the goals of calculable based on
                 the other regulatory changes listed above. available data.
                Title IX regulations, related This amendment ensures the rule of law by clarifying No costs are
                 amendment. that Title IX regulations are subject to the anticipated, and any
                 statute's own abortion-neutrality language and possible costs are not
                 religious exemption. calculable based on
                 available data.
                CMS regulations, conforming These amendments restore the rule of law by confining Costs are not
                 amendments. regulations within the scope of their legal calculable based on
                 authority, and ensure consistency in civil-rights available data.
                 enforcement across the Department's different
                 programs.
                ----------------------------------------------------------------------------------------------------------------
                II. Background
                 On May 18, 2016, the Department finalized a regulation implementing
                Section 1557 of the ACA. The Department had received 402 comments \4\
                in response to a related request for information in 2015, and 24,875
                comments \5\ in response to the relevant Notice of Proposed Rulemaking,
                80 FR 54172-221 (``2015 NPRM'').
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                 \4\ https://www.regulations.gov/docket?D=HHS-OCR-2013-0007. The
                comment docket identifies 162 submissions, but some submissions to
                the docket aggregated multiple comments.
                 \5\ https://www.regulations.gov/docket?D=HHS-OCR-2015-0006. The
                comment docket identifies 2,188 submissions, but some submissions to
                the docket aggregated multiple comments, and ``the great majority''
                of comments were not electronic but were submitted by mail as part
                of ``mass mail campaigns organized by civil rights/advocacy
                groups.'' 81 FR 31376.
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                 Multiple States and private plaintiffs challenged the 2016 Rule in
                Federal district courts in Texas and North Dakota on the grounds that
                it violated Federal laws, including the Administrative Procedure Act
                (``APA'') and the Religious Freedom Restoration Act (``RFRA'').\6\ On
                December 31, 2016, the U.S. District Court for the Northern District of
                Texas preliminarily enjoined, on a nationwide basis, portions of the
                2016 Rule that had interpreted Section 1557 to prohibit discrimination
                on the basis of gender identity and termination of pregnancy.\7\
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                 \6\ Complaint, Franciscan All., Inc. v. Burwell, No. 7:16-cv-
                00108-O (N.D. Tex. Aug. 23, 2016); Religious Sisters of Mercy v.
                Burwell, No. 3:16-cv-386 (D.N.D. filed Nov. 7, 2016); Catholic
                Benefits Association v. Burwell, No.3:16-cv-432 (D.N.D. filed Dec.
                28, 2016).
                 \7\ See Franciscan All., Inc. v. Burwell, 227 F. Supp. 3d 660,
                696 (N.D. Tex. 2016).
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                 On May 2, 2017, the Department of Justice, on behalf of HHS, filed
                a motion for voluntary remand to reassess the reasonableness,
                necessity, and efficacy of the enjoined provisions. On May 24, 2019,
                HHS issued a notice of proposed rulemaking (``the proposed rule'' or
                ``the 2019 NPRM'') to amend the 2016 Rule, as well as its regulations
                effectuating Title IX,\8\ and to make conforming amendments to certain
                nondiscrimination provisions of CMS regulations \9\ covered by Section
                1557. On June 14, 2019, HHS published the proposed rule in the Federal
                Register \10\ and accepted public comment for 60 days thereafter.
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                 \8\ 20 U.S.C. 1681 et seq.; 45 CFR part 86 (Nondiscrimination on
                the Basis of Sex in Education Programs or Activities Receiving
                Federal Financial Assistance).
                 \9\ 42 CFR 438.3, 438.206, 440.262, 460.98, 460.112; 45 CFR
                147.104, 155.120, 155.220, 156.200, 156.1230.
                 \10\ 84 FR 27846 (June 14, 2019) (``Nondiscrimination in Health
                and Health Education Programs'').
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                 On October 15, 2019, upon motion of the plaintiffs, and adopting
                the reasoning from its preliminary injunction order, the U.S. District
                Court for the Northern District of Texas vacated and remanded the ``the
                unlawful portions'' of the 2016 Rule that had been subject to that
                order.\11\ On
                [[Page 37164]]
                November 21, 2019, the court clarified that ``the Court vacates only
                the portions of the Rule that Plaintiffs challenged in this
                litigation,'' namely, ``insofar as the Rule defines `On the basis of
                sex' to include gender identity and termination of pregnancy . . . The
                remainder of 45 CFR part 92 remains in effect.'' \12\
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                 \11\ Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928, 945
                (N.D. Tex. Oct. 15, 2019) (``Since the Court concludes that ``the
                Rule's conflict with its incorporated statute--Title IX--renders it
                contrary to law under the APA,'' the appropriate remedy is vacatur.
                Order 38, ECF No. 62. Accordingly, the Court VACATES and REMANDS the
                unlawful portions of the Rule for Defendants' further consideration
                in light of this opinion and the Court's December 31, 2016 Order.'';
                id. at 947 (``The Court ADOPTS its prior reasoning from the
                preliminary injunction (ECF No. 62) and now HOLDS that the Rule
                violates the APA and RFRA. Accordingly, the Court VACATES and
                REMANDS the Rule for further consideration.'').
                 \12\ Order, Franciscan Alliance, No. 7:16-cv-00108-O *2 (N.D.
                Tex. filed Nov. 21, 2019).
                ---------------------------------------------------------------------------
                 The Department herein finalizes the proposed rule without change,
                except as set forth below, after careful consideration of and responses
                to public comments.
                III. Response to Public Comments on the Proposed Rule
                 The Department received 198,845 comments in response to the
                proposed rule during the public comment period.\13\ Commenters included
                Members of Congress, State and local governments, State-based
                Exchanges, tribes and tribal governments, healthcare providers, health
                insurers, pharmacies, religious organizations, civil rights groups,
                non-profit organizations, and individuals, among others.
                ---------------------------------------------------------------------------
                 \13\ See https://www.regulations.gov/docket?D=HHS-OCR-2019-0007.
                The comment docket identifies 155,966 submissions, but some
                submissions to the docket aggregated multiple comments. HHS
                estimates the disaggregated number of comments to be 198,845.
                ---------------------------------------------------------------------------
                A. General Comments
                 Comment: Several commenters, including healthcare providers,
                explained that although they support nondiscrimination in healthcare
                and equal access to healthcare for all patients, they have difficulty
                complying with the parameters of the 2016 Rule. They believe that civil
                rights protections should be balanced against the burdens they create.
                Accordingly, these commenters support the proposed regulation as it
                limits the burdens imposed on providers.
                 Response: The Department agrees with these commenters' support of
                nondiscrimination in healthcare and intends to robustly enforce the
                civil rights authorities. The Department is also cognizant of unduly
                burdensome regulations. For example, the 2016 Rule did not anticipate
                some costs to covered entities that range from hundreds of millions to
                billions of dollars as a result of notice and taglines requirements.
                Therefore, this final rule seeks to alleviate certain burdens on
                covered entities while still enforcing the nondiscrimination
                requirements of Title VI, Title IX, the Age Act, and Section 504.
                 Comment: Some commenters said the proposed rule would stabilize
                services for individuals with disabilities and create a more equitable
                distribution of health services.
                 Response: The Department agrees. This final rule maintains
                appropriate protections for individuals with disabilities and will
                provide clarity for providers and individuals.
                 Comment: Several commenters expressed concern that eliminating
                discrimination protections in Section 1557 will cause confusion about
                patients' rights and remove access to administrative remedies that were
                previously available.
                 Response: The Department recommits itself in this rule to enforcing
                nondiscrimination on the basis of all categories protected by statute.
                The Department is confident that the clarity associated with
                maintaining longstanding prohibitions on discrimination under Title VI,
                Title IX, the Age Act, and Section 504, and their respective
                implementing regulations, will outweigh any initial confusion stemming
                from the change.
                 Comment: Some commenters noted the extensive process involved in
                developing the 2016 Rule, which included a request for information, the
                2015 NPRM, and the 2016 Rule, with the Department considering more than
                24,875 public comments. Such commenters suggested this proposed rule
                unnecessarily reopens the 2016 Rule and ignores the reasoned process
                that the Department had previously completed. Also, a commenter asked
                why the Department did not publish a request for information before the
                proposed rule. Others stated that the proposed rule relies
                disproportionately on a single district court case, Franciscan
                Alliance,\14\ to justify a new interpretation of sex. The commenters go
                on to suggest that the Department relied exclusively on Franciscan
                Alliance to open up the entire 2016 Rule for edits while ignoring
                numerous other court cases that come to opposing conclusions regarding
                sex discrimination.\15\
                ---------------------------------------------------------------------------
                 \14\ Franciscan Alliance, Inc. v. Burwell, 227 F. Supp. 3d 660
                (N.D. Tex. 2016).
                 \15\ Commenters cited Boyden v. Conlin, 341 F. Supp. 3d 979
                (W.D. Wisc. 2018) (holding Wisconsin's use of transgender exclusions
                in its state employee health insurance plan constituted sex
                discrimination in violation of Section 1557 and Title VII); Flack v.
                Wis. Dept. of Health Servs., 328 F. Supp. 3d 931, 951 (W.D. Wis.
                2018); Prescott v. Rady Children's Hospital-San Diego, 265 F. Supp.
                3d 1090, 1098-100 (S.D. Cal. 2017) (finding Section 1557's plain
                language bars gender identity discrimination); Tovar v. Essential
                Health, 342 F. Supp. 3d 947, 957 (D. Minn. 2018) (same).
                ---------------------------------------------------------------------------
                 Response: On December 31, 2016, the Franciscan Alliance court
                preliminarily enjoined the 2016 Rule's gender identity and termination
                of pregnancy provisions on a nationwide basis, finding them unlawful
                under the APA and RFRA. A few weeks later, a second Federal district
                court preliminarily stayed enforcement of the 2016 Rule against two
                other plaintiffs, citing the Franciscan decision.\16\ Because of the
                nationwide preliminary injunction, the Department could not enforce
                certain provisions from the 2016 Rule. In the process of reconsidering
                the 2016 Rule, and consistent with applicable Executive Orders and
                deregulatory priorities, the Department examined the rule more broadly
                and concluded that, for the reasons explained in the 2019 NPRM, the
                2016 Rule had significantly underestimated the costs and burdens it
                imposed. Because Section 1557 authorizes, but does not require, the
                creation of new implementing regulations, the Department considered it
                appropriate to repeal certain portions of the 2016 Rule and enforce
                Section 1557 using the underlying regulations the Department has used
                to enforce the relevant civil rights statutes identified in Section
                1557. The Department also considered the Executive Branch's most recent
                statements concerning the interpretation of statutory provisions that
                prohibit discrimination on the basis of sex.
                ---------------------------------------------------------------------------
                 \16\ Religious Sisters of Mercy v. Burwell, Nos. 3:16-cv-386 &
                3:16-cv-432 (D.N.D. Order of January 23, 2017). See 84 FR 27848.
                ---------------------------------------------------------------------------
                 The Department published its proposed rule in the Federal Register
                on June 14, 2019, opening a two-month public comment period. The
                Department received nearly 200,000 comments for its review. Through
                this public comment period, the public was given a full opportunity to
                provide the Department with information regarding the proposal. It is
                not necessary to engage in an additional solicitation of public
                comments through a request for information before the notice of
                proposed rulemaking. The Department also reviewed the 2016 Rule record
                and its public comments in considering this final rule.
                 Through this rulemaking, the Department has provided a
                comprehensive rationale for this final rule. The 2019 NPRM summarized
                the Department's legal authority to change the 2016 Rule along with
                policy rationales for doing so. The quantum of evidence necessary to
                justify rescinding provisions of a rule is not greater than the
                evidence needed for issuing it in the
                [[Page 37165]]
                first place.\17\ Moreover, after publication of the proposed rule, the
                Court in Franciscan Alliance issued its final judgment vacating and
                remanding the unlawful portions of the 2016 Rule for the Department's
                further consideration. The Department has considered that vacatur,
                along with the legal authorities and policy rationales discussed in the
                NPRM and this preamble, and more thoroughly calculated the costs and
                effects of the notice and taglines requirements, to arrive at this
                final rule. Specific responses to comments on its various provisions,
                including on sex discrimination, are found below.
                ---------------------------------------------------------------------------
                 \17\ See 84 FR 27850; F.C.C. v. Fox Television Stations, Inc.,
                556 U.S. 502, 514-15 (2009).
                ---------------------------------------------------------------------------
                 Comment: Some commenters expressed concern that the updated Section
                1557 regulations will have unintended consequences and costs for
                healthcare providers and individuals seeking healthcare and insurance,
                particularly pertaining to access standards for people with LEP and
                communication-based disabilities, in part because the regulatory
                drafting period was shorter than the period for the 2016 Rule.
                 Response: The Department has spent several months carefully
                reviewing comments, providing responses to them in this rule, and
                finalizing the proposed rule. The Department is leaving several
                substantive provisions of the 2016 Rule unchanged or substantially
                unchanged. The changes largely consist of excisions of regulatory text
                as opposed to the addition of new text, so it is unsurprising that the
                regulatory drafting period was shorter than the period for the 2016
                Rule. In many instances where new or modified regulatory text was
                proposed, such text was based on existing guidance or regulatory text.
                The Department considers this to be an adequate process and a
                sufficient period of time to engage in such rulemaking.
                 This final rule maintains vigorous protections for people with LEP
                and communication-based disabilities, as discussed in detail below, and
                the Department intends to continue robust enforcement of those
                protections.
                 Comment: Several commenters indicated that the cost savings cited
                in the proposed rule are unsupported or based on insufficient data.
                Several commenters also contend that the proposed rule ignores the
                costs to individuals, especially LEP individuals, who will allegedly
                encounter additional barriers to accessing healthcare as a result of
                the proposed changes. Some commenters were concerned that the proposed
                rule would help eliminate access to a wide range of affordable
                preventive health services, including cancer screenings, contraception,
                and reproductive health services. The commenters believe this loss of
                access will largely be caused by the proposed changes to the definition
                of sex discrimination. Many commenters expressed concern that the
                proposed rule would remove civil rights protections for a number of
                vulnerable groups, including LEP individuals, LGBT individuals,
                individuals with disabilities, and women seeking reproductive
                healthcare. Such commenters state that the removal of these protections
                would, in turn, result in even greater health disparities for these
                vulnerable populations. Some commenters stated that the proposed rule
                would lead to increased discrimination in healthcare, which would lead
                people to delay or forego healthcare and would result in adverse health
                outcomes and greater overall healthcare costs to individuals. Some of
                these commenters note that based on these anticipated increased
                disparities, the proposed rule is effectively encouraging
                discrimination.
                 Response: This final rule leaves in place all statutory civil
                rights protections for vulnerable groups. Cost savings are treated in
                the Regulatory Impact Analysis below, which discusses the data,
                estimates, and assumptions used to support its calculations. Potential
                health disparities or other alleged costs to individuals or vulnerable
                groups, including those due to discrimination or barriers to access,
                are discussed in the relevant sections below (e.g., potential costs to
                LEP individuals are discussed in comments on those sections of the
                regulation that deal with national-origin discrimination and/or LEP,
                while potential costs relating to the gender identity provision are
                discussed in comments on the section regarding ``discrimination on the
                basis of sex'').
                 Comment: Many commenters expressed their belief that this proposed
                rule diverges from the current body of civil rights laws. These
                commenters believe that limiting protections based on gender identity,
                termination of pregnancy, and LEP, runs contrary to civil rights
                protections.
                 Response: Current civil rights laws and their protections are
                discussed, respectively, in the relevant sections below (e.g., civil
                rights law on gender identity is discussed in the section on
                ``discrimination on the basis of sex,'' because the 2016 Rule had
                classified gender identity discrimination as a form of sex-based
                discrimination).
                 Comment: Some commenters stated that civil rights protections
                should not be eliminated because of compliance costs faced by covered
                entities, and that such balancing runs contrary to the Affordable Care
                Act and the Administrative Procedure Act. Such commenters argue that if
                the Department determines that particular protections are too costly or
                onerous, it should advance more limited protections rather than
                eliminating them entirely.
                 Response: This final rule does not, and could not, repeal or
                eliminate specific protections under any of the four civil rights
                statutes referenced in Section 1557, and it does not remove the
                protections provided by the implementing regulations for those
                statutes.
                 The Department has, however, chosen to reduce some excessive
                burdens that were applied to covered entities by the 2016 Rule, but
                were not required by Section 1557, where the relevant civil rights
                protections could be enforced using the underlying regulations without
                the unnecessary burdens imposed by the 2016 Rule.
                 Comment: Commenters stated that the Department exceeded its
                authority by proposing this rule. Some commenters indicated that the
                Department's positions as advanced in the proposed rule are not worthy
                of deference under the framework established in Chevron, U.S.A., Inc.
                v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984), because the
                proposed rule is contrary to clear congressional intent and is
                inconsistent with the agency's past policies concerning sex
                protections. Many of these commenters assert that the changes set forth
                in the proposed rule run contrary to the requirements of the ACA,
                pointing to 42 U.S.C. 18114 (Section 1554), which states that the
                Department shall not ``promulgate any regulation that--(1) creates any
                unreasonable barriers to the ability of individuals to obtain
                appropriate medical care; (2) impedes timely access to health care
                services. . .'' These commenters also state that the Department is
                attempting to make a legislative change through an administrative
                action. Some commenters contend that the proposed rule runs contrary to
                the general intent of the ACA, namely that all individuals should be
                provided access to healthcare.
                 Response: The 2016 Rule tried to make essentially legislative
                changes through administrative action, and those changes were rightly
                held to be in violation of the APA. The Department does not exceed its
                authority by rescinding the portions of the 2016 Rule that exceeded the
                Department's authority. The Department also does not
                [[Page 37166]]
                violate Section 1554 of the ACA by not including the gender identity
                and termination of pregnancy provisions in this final rule, which were
                not supported by the text of the underlying civil rights laws
                incorporated in Section 1557, and in addition were vacated by court
                order.
                 With respect to both Sections 1554 and 1557, the Department
                interprets the ACA by the plain meaning of its text, and as will be
                shown below, this final rule brings the Department's Section 1557
                regulations in line with a proper understanding of the ACA's text.
                Parts of the 2016 Rule exceeded the Department's authority under the
                ACA, and this final rule formally eliminates those portions from the
                Code of Federal Regulations. The Department believes this approach
                adheres more closely to the text of the statutes referenced in Section
                1557, along with the regulations that the Department has used to
                implement those statutes for decades. Other parts of the 2016 Rule are
                being modified or repealed in order to save providers from unnecessary
                burdens not required by the ACA, so that they are better able to
                achieve the statute's goal of providing healthcare access to all
                Americans. Such a reconsideration and elimination of certain regulatory
                provisions, particularly regulations that the ACA itself did not
                require to be issued, neither ``creates'' unreasonable regulatory
                barriers nor impedes timely access to healthcare. If it were otherwise,
                Section 1554 would essentially serve as a one-way ratchet, preventing
                the Department from ever reconsidering a regulation that could be
                characterized as improving access to healthcare in some sense,
                regardless of the other burdens such regulation may impose on access to
                health care. The Department's approach in this final rule is also
                consistent with the Ninth Circuit's recent interpretation of Section
                1554: ``[t]he most natural reading of Sec. 1554 is that Congress
                intended to ensure that HHS, in implementing the broad authority
                provided by the ACA, does not improperly impose regulatory burdens on
                doctors and patients.'' \18\ As explained throughout the preamble, the
                Department's rule avoids precisely such burdens by bringing the section
                1557 regulations into alignment with the longstanding requirements of
                the applicable civil rights laws and their implementing regulations
                (thereby also avoiding additional conscience burdens that the 2016 Rule
                potentially imposed) and by removing notice and taglines requirements
                that imposed unjustified burdens on the healthcare system as a whole
                (some of which would likely have been passed on to individuals).
                ---------------------------------------------------------------------------
                 \18\ California v. Azar, No. 19-15974, 2020 WL 878528, at *18
                (9th Cir. Feb. 24, 2020 (en banc).
                ---------------------------------------------------------------------------
                 Comment: Commenters said that Section 1557 should be construed
                broadly because throughout the ACA, Congress prohibited a variety of
                forms of discrimination, such as against pre-existing conditions and
                combating health disparities. Commenters also indicated that the ACA is
                intended to reduce the cost of healthcare discrimination against the
                poor, so the Section 1557 rule should implement cost sharing and other
                insurance requirements.
                 Response: In the ACA, Congress labeled several provisions other
                than 1557 as prohibiting discrimination \19\ in healthcare, but did not
                incorporate those other provisions of the ACA into Section 1557. Those
                other provisions are different from the civil rights provisions set
                forth in Section 1557 in substance, implementation, and enforcement.
                This final rule commits the Department to robust enforcement of the
                nondiscrimination grounds applicable under Section 1557.
                ---------------------------------------------------------------------------
                 \19\ See, e.g., ACA Section 2701 (``discriminatory premium
                rates''); Section 2716 (``discrimination based on salary''); Section
                2705 (``discrimination against individual participants and
                beneficiaries based on health status''); Section 2716
                (``discrimination in favor of highly compensated individuals'').
                ---------------------------------------------------------------------------
                 Comment: A commenter contended that the Department provided little
                or no legal, policy, or cost-benefit analysis along with the proposed
                rule and combined too many changes into a single rule. Some commenters
                claimed the proposed rule is arbitrary, capricious, and contrary to
                law, is inconsistent with the agency's mission, and lacks reasoned
                explanations justifying the policy reversals. Other commenters stated
                that HHS failed to account for the extensive history of healthcare
                discrimination, and provided no contrary data to counter the original
                factual findings in the 2016 Rule. Furthermore, they said that
                individuals have reasonably placed their reliance upon the Federal
                government to protect their civil rights as explained in the 2016 Rule.
                 Response: The Department provided ample legal, policy, and cost-
                benefit analysis for the proposed rule and provides additional support
                here for the final rule.\20\ The Department proposed changes to the
                provisions of the 2016 Rule because that rule exceeded the Department's
                authority under Section 1557, adopted erroneous and inconsistent
                interpretations of civil rights law, caused confusion, imposed
                unjustified and unnecessary costs, and conflicted with applicable court
                decisions. It is unfortunate that, by administrative action, the 2016
                Rule may have unreasonably raised expectations about nondiscrimination
                protections that are not found in the underlying statutes, but this
                final rule cannot be held responsible for that. The Department gave
                extensive reasons for its changes in the 2019 NPRM, and gives further
                reasons in response to comments below. The public comment process
                provided adequate opportunity to present legal, policy, and cost-
                benefit analyses, all of which were considered in finalizing this rule,
                as discussed herein.
                ---------------------------------------------------------------------------
                 \20\ See 45 FR at 27875-88.
                ---------------------------------------------------------------------------
                 The Department also updates and discusses the regulatory impact
                analysis based on comments and data received. While there are still
                some questions addressed by this final rule where robust data are
                unavailable, were not found by the Department, or have not been brought
                to the Department's attention, the Department is allowed to engage in
                rulemaking even where the impact of a rule change is difficult or
                impossible to quantify. The Department has diligently considered the
                relevant and significant data of which it is aware.
                 There is no artificial limit on the number of changes a proposed
                rule may contain--or on the number of parts in the Code of Federal
                Regulations that can be addressed in a rulemaking. This final rule
                contains many fewer changes than the 2016 Rule did, and it
                substantially streamlines the existing 1557 regulation as opposed to
                enlarging it. Its inclusion of conforming changes to various CMS
                regulations still gives the final rule a size and scope that is well
                within the range of other significant proposed rules.
                 Comment: Several commentators stated that the proposed rule's
                language that Title IX and Section 1557 must be ``exercised with
                respect for State sovereignty'' runs contrary to the Supreme Court's
                decision that Congress has the authority to prohibit discrimination in
                commercial activity.
                 Response: This final rule does not, nor does the Department intend
                to, remove any protection against State action that Congress has
                provided by statute. It also does not deny States the ability to
                provide protections that exceed those required by Federal civil rights
                law. The reference to State sovereignty simply refers to the
                Department's intention to protect the States by respecting their
                sovereignty to the extent that doing so does not infringe on Federal
                law.
                 Comment: One commenter noted that, after the 2016 Rule was passed,
                the
                [[Page 37167]]
                Department released resources and educational materials, including fact
                sheets, to explain the 2016 Rule. The commenter requested that the
                Department release similar resources and educational materials
                following the finalization of this rule.
                 Response: The Department is providing the responses to comments
                contained in this preamble to clarify issues and answer questions
                concerning this final rule. Furthermore, the Department continues to be
                committed to providing resources and educational materials to explain
                civil rights requirements and to assist covered entities with
                compliance with civil rights statutes and the regulations thereunder,
                including this regulation.
                B. Section 1557 Regulation, Subpart A: General Requirements and
                Prohibitions
                 The Department proposed changes to the Section 1557 rule at 45 CFR
                part 92 to be composed of Subpart A on general requirements and
                prohibitions, and Subpart B on specific applications related to
                disability nondiscrimination and language access.
                (1) Proposed Repeal of Definitions in Sec. 92.4 of the 2016 Rule
                 Comments: A commenter contended that eliminating the definitions
                section in the Section 1557 Regulation would cause confusion,
                misinterpretation, and inconsistency of terms among the regulations
                that currently reference or otherwise rely on the underlying
                definitions in the 2016 Rule.
                 Response: In significant part, the definitions section of the 2016
                Rule duplicates definitions already incorporated into the Section 1557
                regulation by reference, and hence creates either inconsistency or
                redundancy. In other cases, the 2016 Rule contained definitions
                inconsistent with the text of applicable statutes; indeed, on those
                grounds, a Federal district court vacated the 2016 Rule's definition of
                ``on the basis of sex'' insofar as it encompassed gender identity and
                termination of pregnancy. The Department will continue to enforce
                Section 1557 using HHS regulations for the underlying civil rights
                statutes. Many of these regulations have definition sections and
                operate based on longstanding understandings of how the laws are
                enforced.
                 Comments: Some commenters argued that eliminating the phrases
                ``covered entities'' and ``health program or activities'' would allow
                many plans and programs to be exempt from the Section 1557 regulation.
                Other commenters stated that the existing definitions provide clarity
                and consistency for covered entities. Another commenter stated that the
                proposed rule would limit Section 1557's application to the specific
                program or activity that receives Federal assistance, rather than a
                healthcare entity's entire operations.
                 Response: See below, under ``Scope of Application in Proposed Sec.
                92.3,'' for a discussion of the entities subject to this final rule.
                 Comment: Some commenters asked the Department to retain the
                definition of ``auxiliary aids and services'' concerning effective
                communication for individuals with disabilities. They also asserted
                that the Department has altered important definitions related to
                effective communication, without explanation or acknowledgement. While
                some commenters appreciated the Department's efforts to incorporate
                many of the current definitions of Title II of the Americans with
                Disabilities Act \21\ (``ADA''), some claim the Department has erred in
                tracking the language of those definitions.
                ---------------------------------------------------------------------------
                 \21\ 42 U.S.C. 12101 et seq.
                ---------------------------------------------------------------------------
                 Response: The Department is not required to track ADA definitions
                in its Section 1557 regulation. This final rule applies many
                definitions based on those found in the ADA or its regulations
                (including ``disability'' and ``auxiliary aids and services''),
                technical definitions and standards under the ADA, and Uniform Federal
                Accessibility Standards as promulgated; as discussed below, it also
                departs from ADA definitions in certain cases. Additionally, this final
                rule retains effective communication standards for individuals with
                disabilities under Sec. 92.102; these provisions are drawn from
                regulations promulgated by the Department of Justice implementing Title
                II of the ADA.\22\ Specific definitions and provisions related to
                individuals with disabilities are discussed below.
                ---------------------------------------------------------------------------
                 \22\ 42 U.S.C. 12311; see also 28 CFR 35.160-164.
                ---------------------------------------------------------------------------
                 The proposed rule apprised the public of the language the
                Department sought to finalize in the rule, gave the Department's
                reasons for changes relative to the 2016 Rule, and provided an
                opportunity to comment on the proposed language.
                 Comment: Some commenters opposed the proposed removal of the
                definition for ``national origin,'' saying it would lead to confusion
                among providers and recipients as to what constitutes discrimination on
                the basis of national origin.
                 Response: The term ``national origin'' is not specifically defined
                in Title VI or in HHS's implementing regulation, but the Department has
                appropriately enforced the prohibition on national origin
                discrimination under Title VI for decades in accord with relevant case
                law. In implementing this final rule, the Department intends to enforce
                vigorously the prohibition on national origin discrimination in a
                manner consistent with the current interpretation under Title VI,
                including under Lau v. Nichols, as discussed below.\23\
                ---------------------------------------------------------------------------
                 \23\ Lau v. Nichols, 414 U.S. 563 (1974).
                ---------------------------------------------------------------------------
                 Comment: Some commenters asserted that the removal of definitions
                weakens protections for LEP individuals and signals a lack of priority
                for enforcement by the Department.
                 Response: As discussed below, meaningful access for individuals
                with LEP is a key component of the national origin protections under
                Title VI and Section 1557, and will be well protected by this final
                rule. The streamlining of this regulation through the elimination of
                largely redundant definitions will in no way impede the Department's
                strong commitment to meaningful access for LEP individuals.
                 Summary of Regulatory Changes: The Department finalizes its repeal
                of Sec. 92.4 of the 2016 Rule without change. Additional comments
                concerning the definitions of sex, gender identity, and other specific
                definitions are discussed in more detail below.
                (2) General Changes to 2016 Rule
                a. Purpose of Regulation, Revising Sec. 92.1 of the 2016 Rule
                 The Department proposed to revise the statement of the purpose of
                the regulation in Sec. 92.1 from ``implement[ation]'' of Section 1557
                to ``provid[ing] for the enforcement'' of Section 1557. 84 FR at 27861.
                 Comment: A commenter said this change in language allows the
                Department to minimize its involvement in ensuring that
                nondiscrimination protections are effective.
                 Response: This is the opposite of the Department's intention. This
                final rule's title and citation to statutory authority already make
                clear that it is implementing Section 1557. By changing the rule's
                language from ``implement'' to ``provide for the enforcement of,'' the
                Department simply means to emphasize, in terms accessible to a lay
                audience, that it will fully enforce Section 1557 and the underlying
                nondiscrimination laws as they fall within the jurisdiction of the
                Department, according to the text of those laws and their implementing
                regulations.
                [[Page 37168]]
                b. Effective Date
                 The Department proposed that the effective date of the revised
                regulation be 60 days after publication of the final rule, in order to
                relieve significant regulatory burdens, particularly the taglines
                requirements.\24\ The 2016 Rule's effective date was July 18, 2016 (60
                days after publication of the final rule), with the exception of the
                provisions on health insurance and benefit design, which went into
                effect on January 1, 2017 (the first day of the first plan year
                following the effective date).\25\ The new rule does not include a
                different effective date for health insurance and benefit design.
                ---------------------------------------------------------------------------
                 \24\ 84 FR at 27888.
                 \25\ 81 FR at 31378.
                ---------------------------------------------------------------------------
                 Comment: Commenters asked that the Department make the effective
                date several months prior to the plan open enrollment period that
                occurs between November 1 and December 15, in order for the covered
                entities to have sufficient time to incorporate the regulatory changes
                into the next plan year.
                 Response: The Department has endeavored to issue this final rule
                sufficiently in advance of the plan year cycle, so that plans can
                incorporate the regulatory changes into the next plan year. Moreover,
                because this final rule generally relieves regulatory requirements
                rather than adding them, it should be easier for issuers to incorporate
                such changes into the plans they will offer for the next plan year.
                 Comment: Commenters stated that it is inappropriate to finalize the
                change to the definition of sex as it relates to Section 1557 in light
                of current litigation before the Supreme Court, which may be resolved
                by the end of the court's term or before. These commenters note that
                the Supreme Court's ruling in R.G. & G.R. Harris Funeral Homes v. EEOC
                & Aimee Stephens \26\ will determine whether Title VII of the Civil
                Rights Act of 1964 extends sex discrimination protections to
                transgender status, and that the ruling may apply to the definition of
                sex under Title IX as well. Accordingly, these commenters urge the
                Department to wait until the Supreme Court decides Harris Funeral Homes
                before publishing a rule that deals with the same subject matter, or
                allow for commenters to comment again once the case has been decided.
                ---------------------------------------------------------------------------
                 \26\ R.G. & G.R. Harris Funeral Homes, Inc. v. E.E.O.C., 139 S.
                Ct. 1599 (2019).
                ---------------------------------------------------------------------------
                 Response: The Department acknowledges the commenters' point of view
                but respectfully disagrees. The U.S. government has taken the position
                in Harris and other relevant litigation that discrimination ``on the
                basis of sex'' in Title VII and Title IX does not encompass
                discrimination on the basis of sexual orientation or gender
                identity.\27\ The Department shares that position and is permitted to
                issue regulations on the basis of the statutory text and its best
                understanding of the law and need not delay a rule based on speculation
                as to what the Supreme Court might say about a case dealing with
                related issues. The Department also agrees with the Franciscan Alliance
                ruling, according to which the 2016 Rule's extension of sex-
                discrimination protections to encompass gender identity was contrary to
                the text of Title IX and hence not entitled to Chevron deference.\28\
                Moreover, to the extent that a Supreme Court decision is applicable in
                interpreting the meaning of a statutory term, the elimination of a
                regulatory definition of such term would not preclude application of
                the Court's construction.
                ---------------------------------------------------------------------------
                 \27\ As noted elsewhere in this preamble, it has been the
                consistent position of the federal government that ``on the basis of
                sex'' under Section 1557 does not encompass sexual orientation,
                including the decision in the 2016 Rule not to include sexual
                orientation in the definition of that term. See 81 FR at 31390.
                 \28\ Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928, 945
                (N.D. Tex. Oct. 15, 2019) (incorporating its previous ruling at 227
                F. Supp. 3d at 685-87).
                ---------------------------------------------------------------------------
                 The Department continues to expect that a holding by the U.S.
                Supreme Court on the meaning of ``on the basis of sex'' under Title VII
                will likely have ramifications for the definition of ``on the basis of
                sex'' under Title IX.\29\ Title VII case law has often informed Title
                IX case law with respect to the meaning of discrimination ``on the
                basis of sex,'' \30\ and the reasons why ``on the basis of sex'' (or
                ``because of sex,'' as used in Title VII) does not encompass sexual
                orientation or gender identity under Title VII have similar force for
                the interpretation of Title IX. At the same time, as explained below,
                the binary biological character of sex (which is ultimately grounded in
                genetics) takes on special importance in the health context. Those
                implications might not be fully addressed by future Title VII rulings
                even if courts were to deem the categories of sexual orientation or
                gender identity to be encompassed by the prohibition on sex
                discrimination in Title VII. As a result, the Department considers it
                appropriate to finalize this rule, which does not define sex, but
                relies on the plain meaning of the term under Title IX, and does so in
                the health context within which the Department applies Title IX under
                Section 1557.
                ---------------------------------------------------------------------------
                 \29\ See 84 FR 27855.
                 \30\ See, e.g., Yusuf v. Vassar Coll., 35 F.3d 709, 714 (2d Cir.
                1994).
                ---------------------------------------------------------------------------
                 Comment: Commenters disagreed with the Department's reliance on the
                litigation and court order in Franciscan Alliance to justify revisiting
                the rule, because the injunctive order was not permanent, was allegedly
                limited to enforcement actions of HHS, and does not require new
                rulemaking, and because other litigants have intervened in the case to
                defend the 2016 Rule. Some commenters stated that although the U.S.
                District Court in Franciscan Alliance ruled against the 2016 Rule's
                definition of sex, other courts have come to conclusions that suggest
                the opposite, and HHS is not required to alter Department-wide policy
                based on the injunction in Franciscan Alliance. Others argued that the
                Department improperly relied on one legal decision that they said
                conflicts with the clear weight of case law. Another commenter stated
                it would be inappropriate to publish any new rule before a final ruling
                in Franciscan Alliance, as the case is being appealed.
                 Response: Nearly three years after the preliminary injunction, and
                after the comment period on the proposed rule had concluded, the court
                in Franciscan Alliance issued a final ruling vacating the 2016 Rule
                ``insofar as the Rule defines 'On the basis of sex' to include gender
                identity and termination of pregnancy,'' and remanding the Rule for
                further consideration.\31\ This final ruling is binding on the
                Department despite the appellate proceedings still pending in that
                case: The Department's Section 1557 regulation, as currently operative,
                does not contain the 2016 Rule's definition of ``on the basis of sex''
                to encompass gender identity and termination of pregnancy. The
                Franciscan Alliance court's 2016 injunction gave the Department good
                cause to reconsider the 2016 Rule, but neither the injunction nor the
                vacatur was the Department's only reason for revising it, as the
                proposed rule made clear and as the Department's responses to comments
                in this preamble reiterate. Nothing in the appellate litigation
                prohibits the Department from finalizing this rule, which it does for
                the reasons given in this preamble. As for the weight of case law, it
                is discussed below with respect to the respective provisions of this
                final rule.
                ---------------------------------------------------------------------------
                 \31\ Order, Franciscan Alliance, No. 7:16-cv-00108-O *2 (N.D.
                Tex. filed Nov. 21, 2019).
                ---------------------------------------------------------------------------
                 Comment: One commenter noted that the Department's announcement of
                the proposed rule on May 24, 2019 had stated that a fact sheet
                explaining the changes in the proposed rule would be
                [[Page 37169]]
                provided in Spanish. However, no such fact sheet has been provided.
                Accordingly, the commenter requested that the comment period be
                extended until 60 days after the fact sheet is published in Spanish.
                 Response: The proposed rule itself did not purport to offer
                information in Spanish, and the Department was not under a legal
                obligation to offer a separate fact sheet or to translate it. The
                Department's press release indicated that a fact sheet, separately
                created in connection with the press release, would be translated. That
                is not a basis for reopening the comment period on the proposed rule,
                because the proposed rule provided the public with adequate notice and
                a 60-day public comment period, which were legally sufficient.
                c. Severability
                 The Department proposed to repeal the provision in Sec. 92.2(c) of
                the 2016 Rule stating that if a regulatory provision in this part were
                held invalid or unenforceable on its face or as applied to a specific
                person or circumstances, the provision should be construed to the
                maximum effect permissible by law and be severable such that it would
                not affect other persons or circumstances that are dissimilar.
                 Comment: Commenters asked the Department to add a severability
                provision to the final rule. Specific points recommended included
                severing repeal of the provisions related to the notices and taglines,
                and/or the changed scope of applicability, from the sex discrimination
                provisions. Commenters said that the Supreme Court case K-Mart Corp. v.
                Cartier, Inc., 108 S. Ct. 1811 (1988), would allow the Department to
                sever the changes in the taglines provision from the proposed rule and
                implement those changes even in the event that a court delays or
                suspends the proposed rule.
                 Response: In part due to these comments, the Department has decided
                not to finalize the proposal to eliminate the severability provision
                from the 2016 Rule. Instead the Department will retain that
                severability provision, but has moved it to Sec. 92.3(d), because
                Sec. 92.3 is now the provision addressing the application of the rule.
                This change will be discussed again below in the discussion of Sec.
                92.3.
                d. Summary of Regulatory Changes
                 For the reasons described in the proposed rule, and having
                considered the comments received, the Department finalizes the proposed
                Sec. 92.1 without change, and confirms that the effective date of this
                final rule will be 60 days after its publication in the Federal
                Register.
                (3) Scope of Application in Proposed Sec. 92.3; Repeal of Sec. 92.208
                 The Department proposed to repeal Sec. 92.2 of the 2016 Rule, and
                instead address the scope of application of Section 1557 in a new Sec.
                92.3. 84 FR at 27862-63. The Department also proposed to repeal Sec.
                92.208 of the 2016 Rule, which had expanded the scope of the Section
                1557 statutory provision to apply to certain employee health benefits
                programs.\32\
                ---------------------------------------------------------------------------
                 \32\ Compare 45 CFR 92.208 (employer liability for
                discrimination in employee health benefit programs in Section 1557)
                with 45 CFR 86.56 (discrimination on the basis of sex in fringe
                benefits under Title IX. The enforcement Memorandum of Understanding
                (MOU) between OPM and the Department, signed by OCR on 11 January
                2017, is moot upon publication of this final rule.
                ---------------------------------------------------------------------------
                a. Generally
                 Comment: Commenters argued the Department did not provide a
                reasoned legal, policy, or cost-benefit analysis to support the repeal
                of Sec. 92.208, which hindered their ability to provide meaningful
                comments as required by the APA. The commenters maintained that the
                Department's comparison of Sec. 92.208 to Title IX \33\ was flawed, in
                part because HHS's Title IX regulation does not apply to all bases of
                discrimination or many of the same covered entities as addressed under
                Section 1557. Some commenters noted that employees deserve protection
                from discrimination in employer-sponsored plans.
                ---------------------------------------------------------------------------
                 \33\ 84 FR at 27869, n.148 (comparing Sec. 92.208 with 45 CFR
                86.56 (discrimination on the basis of sex in fringe benefits under
                Title IX)).
                ---------------------------------------------------------------------------
                 Response: As seen below in the response to a similar comment on
                Sec. 92.207, Sec. 92.208 appears in the NPRM in a list of sections of
                the 2016 Rule that ``are duplicative of, inconsistent with, or may be
                confusing in relation to the Department's preexisting Title VI, Section
                504, Title IX, and the Age Act regulations.'' \34\ The Department
                repeals Sec. 92.208 for reasons similar to those given at greater
                length below in discussing Sec. 92.207: It seeks to relieve regulatory
                burden and possible confusion by enforcing the relevant
                nondiscrimination statutes through their existing regulations.
                ---------------------------------------------------------------------------
                 \34\ 84 FR 27869.
                ---------------------------------------------------------------------------
                 The Department is not aware of data and methods available to make
                reliable estimates of all economic impacts predicted by various
                commenters. The Department's estimates of regulatory impact are
                discussed below.
                 Comment: Commenters stated that individuals protected by Section
                1557, particularly individuals with disabilities, frequently experience
                discrimination in healthcare. Commenters expressed concerns that the
                narrowed application would reduce the number of covered entities and
                would lead to more discrimination, lack of care, and adverse health
                outcomes, which they argued is contrary to the stated Congressional
                intent and purpose of the ACA to expand access to and end
                discrimination in health insurance. Several State and local government
                commenters expressed concern that the proposed rule would negatively
                affect public health in their States and increase costs to States due
                to more people seeking care through government-funded programs, such as
                Medicaid.
                 Conversely, other commenters were supportive of the proposed rule's
                revised scope and agreed that the 2016 Rule was far too broad in its
                application. They concurred that narrowing the scope of application
                would help rein in the regulatory excess and burden of the 2016 rule.
                 Response: The Department must follow the text of the ACA. To the
                extent that Congressional intent and purpose are relevant, they are
                best determined by looking to the plain meaning of the statutory text.
                This final rule will enforce Section 1557's discrimination requirements
                against the entities that Congress intended them to be enforced
                against. The Department's specific reasoning in interpreting Section
                1557's scope of coverage follows.
                b. Sec. 92.3(a): Covered Programs and Activities
                 The Department proposed in Sec. 92.3(a) that, except as otherwise
                provided in part 92, the Section 1557 rule will apply to (1) any health
                program or activity, any part of which is receiving Federal financial
                assistance (including credits, subsidies, or contracts of insurance)
                provided by the Department; (2) any program or activity administered by
                the Department under Title I of the ACA; or (3) any program or activity
                administered by any entity established under Title I of the ACA.
                 Comment: Some commenters opposed removing the full definition of
                ``Federal financial assistance'' from the 2016 Rule and replacing it
                with the limited text under proposed Sec. 92.3(a)(1). They stated that
                the lack of specificity could lead to ambiguity and confusion.
                Commenters further asserted that the proposed rule was inconsistent
                with the Department's recently promulgated Protecting Statutory
                Conscience Rights in Health
                [[Page 37170]]
                Care (``2019 Conscience Rule''),\35\ which included an expansive
                definition of ``Federal financial assistance.'' \36\
                ---------------------------------------------------------------------------
                 \35\ Protecting Statutory Conscience Rights in Health Care;
                Delegations of Authority, 84 FR 23170-01 (2019).
                 \36\ 45 CFR 88.2.
                ---------------------------------------------------------------------------
                 Response: The Department concludes it is appropriate to have a
                definition of Federal financial assistance that mirrors Section 1557's
                statutory text to include ``credits, subsidies, or contracts of
                insurance.'' In addition, the definitions applicable under the
                preexisting civil rights statutes still apply, and the Department
                believes it is more appropriate to apply those existing definitions
                than to maintain the ones in the 2016 Rule. Section 1557 says the
                enforcement mechanisms provided for and available under the underlying
                civil rights statutes shall apply, and the Department believes
                operating under those mechanisms and the definitions that have long
                been applicable to them, along with the language the Department retains
                in this final rule, is appropriate moving forward. The 2019 Conscience
                Rule was based on different statutes.
                 Comment: Some commenters opposed the proposed rule's exclusion of
                Federal financial assistance that the Department ``plays a role'' in
                providing or administering, which had been included in the 2016 Rule's
                definition of Federal financial assistance. Commenters argued that the
                statute applies to programs or activities administered by ``an
                Executive Agency'' and thus should not be limited to HHS. In
                particular, they objected to the result that qualified health plans
                (QHPs) would no longer be covered under the rule on the basis that HHS
                plays a role in administering tax credits. The commenters argued that
                this interpretation is contrary to a plain reading of the statute,
                which not only uses the broad term ``Federal financial assistance''
                (without a modifier to limit it to assistance directly administered by
                HHS), but also expressly includes ``credits'' as part of Federal
                financial assistance. Further, some commenters noted that the
                Department took an inconsistent and broader approach in its Conscience
                Rule, wherein HHS exerts jurisdiction over statutes and funding also
                administered by the U.S. Departments of Labor and Education.
                 Response: The statutory text of Section 1557 refers simply to ``any
                health program or activity, any part of which is receiving Federal
                financial assistance, including credits, subsidies, or contracts of
                insurance.'' Because the Section 1557 regulation applies only to the
                Department, the 2015 NPRM had reasonably sought to limit its scope to
                Federal financial assistance from the Department, leaving other
                Departments to enforce Section 1557 within their own sphere.\37\ In the
                2016 Rule, however, wishing to encompass tax credits administered under
                Title I, the Department expanded the rule's scope to encompass
                ``Federal financial assistance that the Department plays a role in
                providing or administering.'' \38\ The Department now regards this
                expansion as overbroad. While Section 1557 still applies to any health
                program or activity receiving any Federal financial assistance, this
                final rule prescribes enforcement only by the Department and within the
                Department's jurisdiction. The Department does not consider it
                appropriate in this final rule to apply its provisions to any programs
                that the Department ``plays a role in'' administering.
                ---------------------------------------------------------------------------
                 \37\ 80 FR 54173 (``Section 1557 applies to all health programs
                and activities, any part of which receives Federal financial
                assistance from any Federal Department. However, this proposed rule
                would apply only to health programs and activities any part of which
                receives Federal financial assistance from HHS. This narrowed
                application is consistent with HHS' enforcement authority over such
                health programs and activities, but other Federal agencies are
                encouraged to adopt the standards set forth in this proposed rule in
                their own enforcement of Section 1557.'').
                 \38\ 81 FR 31467, 31384; cf. 80 FR 54216.
                ---------------------------------------------------------------------------
                 Commenters' concerns about covering QHPs are misplaced: These plans
                remain subject to this rule because they are sold on the Exchanges
                established under Title I of the ACA (see Sec. 92.3(a)(3) of this
                final rule). This final rule only prescribes enforcement of Section
                1557 by the Department and within the Department's jurisdiction, so the
                Department believes it is appropriate for this regulation to not
                include activities funded or administered solely by other Federal
                agencies even if Section 1557 may apply in those instances.
                 The 2019 Conscience Rule (as stated above) relied on different
                statutes than the Section 1557 rule, and the Department drafts its
                regulations as appropriate for the underlying statutes.
                 Comment: Commenters disapproved of proposed Sec. 92.3(a)(2), which
                would limit the rule's application in the context of HHS-administered
                programs or activities to only those administered under Title I of the
                ACA. Commenters argued that this interpretation is inconsistent with
                the statutory text of Section 1557, which applies to ``any program or
                activity administered by an Executive Agency or any entity established
                under this title [sc., Title I].'' (emphasis added). Commenters argued
                the proposed Sec. 92.3(a)(2) would incorrectly apply ``under this
                title'' to modify both phrases. Furthermore, they argued that the
                Department did not provide an adequate rationale for its interpretation
                in the proposed rule.
                 Response: As explained in the 2019 NPRM, the statutory text of
                Section 1557 applies to ``any program or activity'' administered by an
                Executive Agency or Title I entities, but does not include the modifier
                ``health'' with respect to those programs or activities.\39\ In the
                2016 Rule, the Department limited its application by adding ``health''
                to ``programs or activities'' because the Department recognized that
                Section 1557 was not intended to apply to every program or activity
                administered by every Executive Agency, whether or not it related to
                health.\40\ The 2016 Rule acknowledged implicitly what the Department
                now states more clearly: The grammar of the relevant sentence in the
                Section 1557 statutory text concerning limits to its scope is less
                clear than it could have been. In resolving the sentence's ambiguity,
                however, the Department no longer agrees with the 2016 Rule's decision
                to add a limiting modifier (i.e., ``health'') that Congress did not
                include in the statutory text. Instead, the Department concludes that
                Congress had already placed a limitation in the text of Section 1557 by
                applying the statute to any program or activity administered by an
                Executive Agency ``under this title'' (meaning Title I of the ACA), as
                well as to any program or activity administered by an entity
                established under such title. The Department believes that either this
                interpretation of the statutory text, or the 2016 Rule's addition of
                the modifier ``health,'' is necessary in order to make sense of the
                statutory text; this final rule offers a technical reading of the text
                that is at least as reasonable as the 2016 Rule's addition of a word
                not present in the text of the statute.
                ---------------------------------------------------------------------------
                 \39\ 42 U.S.C. 18116(a) (applying Section 1557, in relevant
                part, to ``any program or activity that is administered by an
                Executive Agency or any entity established under this title (or
                amendments).''). See also 84 FR at 27861-62 (discussing the
                Department's statutory interpretation).
                 \40\ 45 CFR 92.2 (applying the final rule, in relevant part, to
                ``every health program or activity administered by the Department;
                and every health program or activity administered by a Title I
                entity'') (emphasis added).
                ---------------------------------------------------------------------------
                 Comment: Commenters argued that the proposed interpretation to
                limit coverage to HHS Title I programs or activities would exclude a
                number of important programs and activities operated by HHS and is
                inconsistent with Section 504's application to ``any program or
                activity conducted by an
                [[Page 37171]]
                Executive Agency.'' \41\ They point out that HHS's Section 504
                regulation applies to ``all programs or activities'' conducted by HHS
                and all its components, including CMS, HRSA, CDC, and SAMHSA.\42\
                Further, commenters stated that excluding non-Title I HHS-administered
                programs and activities, contrary to Section 504, will result in
                confusion and cause illogical results, whereby recipients would be
                covered by Section 1557 but the agencies administering the program
                would not be covered. For example, State Medicaid programs would be
                subject to Section 1557, but CMS, which oversees those Medicaid
                programs, would not be covered.
                ---------------------------------------------------------------------------
                 \41\ 29 U.S.C. 794 (applying to ``any program or activity
                receiving Federal financial assistance or under any program or
                activity conducted by any Executive agency or by the United States
                Postal Service'').
                 \42\ 45 CFR, part 85.
                ---------------------------------------------------------------------------
                 Response: Section 1557 is a nondiscrimination statute under the
                ACA, which uniquely applies to healthcare, whereas Section 504 is a
                statute of general applicability. Section 1557 incorporates Section
                504's prohibited grounds of discrimination but not its scope: Section
                1557's scope differs from that of the underlying statutes. For
                instance, Section 504 does not include ``contracts of insurance'' in
                its definition of Federal financial assistance,\43\ but this final rule
                follows the text of Section 1557 by including ``contracts of
                insurance'' within Federal financial assistance.\44\ With respect to
                CMS, it is covered under this final rule to the extent that it either
                administers health programs and activities receiving Federal financial
                assistance or administers programs and activities under Title I. In
                addition, it is important to note that, as a federal agency, CMS has
                long been subject to various constitutional and statutory prohibitions
                on discrimination.
                ---------------------------------------------------------------------------
                 \43\ 45 CFR 84.3(h).
                 \44\ 42 U.S.C. 18116(a).
                ---------------------------------------------------------------------------
                c. Sec. 92.3(b): Scope of the Term ``Health Program or Activity''
                 The Department proposed in Sec. 92.3(b) to clarify that ``health
                program or activity'' encompasses all of the operations of entities
                ``principally engaged in the business of providing healthcare'' that
                receive Federal financial assistance. The Department proposed to
                further clarify that for any entity not principally engaged in the
                business of providing healthcare, such entity's operations are subject
                to the Section 1557 Rule only to the extent any such operation receives
                Federal financial assistance provided by the Department.
                 Comment: Commenters opposed limiting application of the rule when
                the entity is not principally engaged in the business of providing
                healthcare. Commenters argued that this would dramatically limit the
                scope of the rule and is contrary to Congressional intent and the plain
                meaning of the statute, which covers ``any health program or activity,
                any part of which is receiving Federal financial assistance. . . .''
                Commenters stated that the entire entity receiving Federal financial
                assistance should be covered, not just the portion receiving funding.
                Commenters also argued the new framework would cause uncertainty and
                confusion for covered entities, which would have to clarify the extent
                of their own compliance, and also would make it harder for consumers to
                enforce their rights because they would have difficulty determining
                which entities and which portion of their programs or activities are
                subject to the rule. Commenters contended this uncertainty could result
                in lack of access to care, increased health disparities, and increased
                uncompensated care, all of which would increase overall healthcare
                costs.
                 Some commenters stated that the rule incorrectly incorporates the
                Civil Rights Restoration Act (CRRA) \45\ into Section 1557. Commenters
                argued that the CRRA predates the ACA; nothing in the CRRA's text
                applies it to future statutes or Section 1557; Congress did not
                incorporate the CRRA into the Section 1557 statute; and Section 1557
                itself is more expansive than the laws amended by the CRRA. Therefore,
                they say, a broader definition of covered programs and activities
                should apply to include all health insurers as covered entities. Others
                argued that the proposed rule's application of the CRRA contravenes the
                approach taken by Congress in the CRRA. They stated that Congress made
                clear in the CRRA that if any part of a program or activity receives
                Federal financial assistance, the entire program or activity must
                comply with the applicable civil rights laws. Thus, the commenters
                argued that the proposed rule's limited application when entities are
                not principally engaged in the business of healthcare, to cover only
                the specific operation that receives Federal financial assistance, is
                contrary to the CRRA. Another commenter stated that incorporating the
                CRRA into Section 1557 would be subject to judicial review, to the
                extent the Department relies on Section 1557's references to
                ``grounds'' and ``enforcement mechanisms'' of the underlying statutes
                to do so, because the Supreme Court held in Consolidated Rail Corp. v.
                Darrone that a statute's incorporation of another statute's enforcement
                mechanisms does not necessarily incorporate its substantive law.\46\
                ---------------------------------------------------------------------------
                 \45\ Public Law 100-259, 102 Stat. 28 (Mar. 22, 1988).
                 \46\ See Consolidated Rail Corp. v. Darrone, 465 U.S. 624, 635
                (1984) (holding that Section 504's incorporation of the ``remedies,
                procedures, and rights'' set forth in Title VI did not mean that
                Section 504 incorporated Title VI's substantive limitations on
                actionable discrimination).
                ---------------------------------------------------------------------------
                 Conversely, other commenters were supportive of reducing regulatory
                burden by limiting application of the rule in this way. They stated
                that the 2016 Rule defined ``covered entities'' far too broadly, and
                that narrowing the scope will help rein in the regulatory excess of
                that rule. Commenters explained that healthcare entities often provide
                a variety of services and products, such as insurance coverage for
                life, disability, or short-term limited duration insurance coverage,
                and third-party administrative services, which do not receive Federal
                financial assistance. These commenters agreed that Section 1557 is
                intended to apply only to those programs receiving Federal funding and
                not to other parts of the entity's businesses or products when an
                entity is not principally engaged in the business of providing
                healthcare.
                 Response: Section 1557 explicitly incorporates statutes amended by
                the CRRA, and in this final rule the Department is aligning Section
                1557's definition of ``health program or activity'' with the standard
                articulated in the CRRA in order to provide clarity and consistency.
                The CRRA clarified the scope of nondiscrimination prohibitions under
                the civil rights statutes that Section 1557 incorporates. For example,
                with respect to the health sector, it applied those prohibitions to all
                health programs or activities receiving Federal financial assistance,
                but not to all providers of health insurance: It applied ``program or
                activity'' to cover all of the operations of an entity only when that
                entity is ``principally engaged in the business of providing . . .
                health care . . . .'' \47\ This final rule clarifies that the term
                ``health program or activity'' used in Section 1557 should be
                understood in light of the CRRA's limitations on the term ``program or
                activity'' as applied to statutes on which Section 1557 relies. As for
                Consolidated Rail Corp. v. Darrone, Congress specifically and
                intentionally
                [[Page 37172]]
                overturned that case through the passage of the CRRA.\48\
                ---------------------------------------------------------------------------
                 \47\ See, e.g., CRRA Sec. 3(a) (adding Sec. 908(3)(A)(ii) to
                Title IX of the Education Amendments of 1972 (codified at 20 U.S.C.
                1687(3)(A)(ii)).
                 \48\ See McMullen v. Wakulla Cty. Bd. of Cty. Commissioners, 650
                F. App'x 703, 705 (11th Cir. 2016), citing S. Rep. No. 100-64, at 2
                (1988), as reprinted in 1988 U.S.C.C.A.N. 3, 3-4.
                ---------------------------------------------------------------------------
                 The 2016 Rule also articulated a standard for ``health program or
                activity'' that relied upon the ``principally engaged'' prong of the
                CRRA, which was contested neither before nor after that rule's
                publication. In the regulatory text, the 2016 Rule defined ``health
                program or activity'' to apply to all operations of an entity only when
                it is principally engaged in providing or administering health
                services, health insurance coverage, or other health coverage.\49\ The
                2016 Rule preamble clarified that if an entity is not principally
                engaged in providing health benefits, the Department would apply the
                rule to its Federally funded health programs and activities.\50\
                ---------------------------------------------------------------------------
                 \49\ 81 FR at 31467. In the proposed rule, the Department
                disagreed with the 2016 Rule's usage of ``health services, health
                insurance coverage, or other health coverage'' as overbroad and
                inconsistent with the statutory text of the CRRA that uses the term
                ``healthcare.'' See 84 FR at 27862-63. However, the Department
                agrees with the 2016 Rule's limitation based on whether the entity
                is principally engaged.
                 \50\ 81 FR at 31385-86, 31430-32.
                ---------------------------------------------------------------------------
                 The Department believes that by specifying the degree to which the
                Section 1557 regulation covers entities not principally engaged in the
                business of providing healthcare, this final rule more clearly and
                consistently applies the CRRA's limitations on ``health program or
                activity'' across the regulation. The Department agrees with commenters
                who suggest that in doing so this final rule also advances its goal of
                reducing regulatory burdens under the ACA in furtherance of Executive
                Order 13765.
                 Comment: Commenters argued that limiting the application of the
                rule to only the portion of the health program or activity that
                receives Federal financial assistance for entities not principally
                engaged in the business of providing healthcare is not consistent with
                the Department's application of Title VI as set forth in HHS's 2003 LEP
                guidance. This guidance provided that Title VI applies to all parts of
                a covered entity receiving Federal financial assistance, not just the
                portion receiving Federal funds.\51\
                ---------------------------------------------------------------------------
                 \51\ 68 FR 47311, 47313 (Aug. 8, 2003) (``Coverage extends to a
                recipient's entire program or activity, i.e., to all parts of a
                recipient's operations. This is true even if only one part of the
                recipient receives the Federal assistance.'').
                ---------------------------------------------------------------------------
                 Response: As a policy guidance document, the Department's LEP
                guidance cannot be used to create binding standards by which the
                Department will determine compliance with existing regulatory or
                statutory requirements.\52\ Accordingly, the scope of application as
                set forth under the CRRA and this final rule would prevail over any
                conflicting text in the Department's LEP guidance.
                ---------------------------------------------------------------------------
                 \52\ See U.S. Dept. of Justice, Memorandum of the Office of the
                Attorney General, Prohibition on Improper Guidance Documents (Nov.
                16, 2019), https://www.justice.gov/opa/press-release/file/1012271/download; U.S. Dept. of Justice, Memorandum of the Office of the
                Associate Attorney General, Limiting Use of Agency Guidance
                Documents In Affirmative Civil Enforcement Cases (Jan. 25, 2018),
                https://www.justice.gov/file/1028756/download.
                ---------------------------------------------------------------------------
                d. Sec. 92.3(c) Health Insurance and Healthcare
                 The Department proposed in Sec. 92.3(c) to state that an entity
                principally or otherwise engaged in the business of providing health
                insurance would not be considered to be principally engaged in the
                business of providing healthcare, and on that sole basis, subject to
                the Section 1557 regulation. The proposed rule sought comment on
                whether it should define ``healthcare'' in the rule according to the
                statutes cited in the proposed rule.
                 Comment: Several commenters supported the distinction between
                entities principally engaged in the business of providing healthcare
                and those principally engaged in the business of providing health
                insurance. As one commenter stated, ``[p]aying for healthcare is not
                providing healthcare.'' Other commenters were opposed to this
                distinction. They argued that it is not consistent with Section 1557's
                statutory text or the proposed regulatory text at Sec. 92.3(a)(1),
                both of which specifically include ``contracts of insurance'' as an
                example of Federal financial assistance. They also stated that this
                limited application is not consistent with Congressional intent to
                expand access to healthcare and create new nondiscrimination
                protections in health insurance.
                 Some commenters argued that health insurance is inextricably linked
                with the provision of healthcare. They pointed out that the statutory
                definition of ``healthcare'' relied upon in the proposed rule is
                unrelated to either the ACA, health insurance, or discrimination, and
                thus is not intended for or relevant to Section 1557 or health
                insurance.\53\ Further, they argued that the definition of ``health
                insurance coverage'' referenced in the proposed rule, 42 U.S.C. 300gg-
                91, actually bolsters the argument that health insurance includes
                healthcare, as it defines ``health insurance coverage'' to include
                ``benefits consisting of medical care (provided directly, through
                insurance or reimbursement, or otherwise and including items and
                services paid for as medical care)'' (emphasis added). They also
                pointed out that definitions in 42 U.S.C. 300gg-91 are most relevant to
                Section 1557 because Title I of the ACA relied upon this section for
                definitions.
                ---------------------------------------------------------------------------
                 \53\ See 84 FR at 27862 (citing the definition of ``health
                care'' at 5 U.S.C. 5371). Commenters noted that this definition
                pertains to Federal personnel pay rates.
                ---------------------------------------------------------------------------
                 Response: The CRRA defined ``program or activity'' in the
                underlying statutes to apply to all of an entities' operations when it
                is principally engaged in the business of providing ``healthcare.'' On
                the other hand, the 2016 Rule expansively interpreted Section 1557's
                application to ``health programs or activities'' to include all
                operations of entities that ``provide health insurance coverage or
                other health coverage,'' whether or not they provided healthcare. Prior
                to the 2016 Rule, the Department had not interpreted the CRRA's term
                ``healthcare'' to cover the operations of health insurance issuers (as
                such).
                 Commenters are correct that Section 1557 includes ``contracts of
                insurance'' as a type of Federal financial assistance. The Department
                agrees that health programs or activities that receive contracts of
                insurance from the Federal government are covered entities under
                Section 1557. But this does not mean that health insurers, as such, are
                health programs or activities.
                 The Department pointed to 5 U.S.C. 5371, as well as to 45 CFR
                160.103, in order to support its conclusion that the plain meaning of
                ``healthcare'' differs from insurance. And although 42 U.S.C. 300gg-91
                explicitly encompasses payment, ``group health plans,'' and
                ``definitions relating to health insurance'' specifically, it should
                not be taken out of context: It defines ``medical care'' as ``amounts
                paid for'' certain medical services, which is an appropriate definition
                in the health insurance field but not in the healthcare field
                generally. (When a doctor provides ``medical care,'' she is not
                providing ``amounts paid for'' medical services--she is providing the
                services themselves.) Other portions of 42 U.S.C. 300gg-91 also support
                the distinction between healthcare and health insurance: It says that
                ``health insurance coverage means benefits consisting of medical
                care,'' where ``medical care'' is defined as ``amounts paid for . . .
                the diagnosis, cure, mitigation, treatment, or prevention of disease,
                or amounts paid for the purpose of affecting any structure or function
                of the body,'' or
                [[Page 37173]]
                ``amounts paid for transportation primarily for and essential to
                medical care'' in the primary sense just defined, or ``amounts paid for
                insurance covering medical care'' in either the primary sense just
                defined or the secondary sense of transportation for medical care.\54\
                It does not say that health insurance is healthcare, and it twice
                relies on the commonsense distinction between medical care proper and
                the health insurance that covers and pays for such care. It thus
                supports the Department's view that a health insurer is principally
                engaged in the business of providing coverage for benefits consisting
                in healthcare, which is not the same as the business of providing
                healthcare. This final rule brings the 1557 regulation's scope of
                coverage closer to the plain meaning of the 1557 statute, especially as
                read in light of the CRRA's definition of ``program or activity.''
                ---------------------------------------------------------------------------
                 \54\ 42 U.S.C. 300gg-91(b)(1), (a)(2).
                ---------------------------------------------------------------------------
                 Comment: Commenters were concerned that Sec. 92.3(c) would result
                in exempting many of the plans, products, and operations of most health
                insurance issuers, such as self-funded group health plans, the Federal
                Employees Health Benefits (FEHB) Program, third-party administrator
                services, or short-term limited duration insurance plans. Commenters
                feared this would allow health insurance issuers to conduct their other
                activities in a discriminatory manner. Several commenters were
                particularly concerned about excluding short-term limited duration
                insurance plans because these plans have been known to engage in
                discriminatory practices based on disability, age, and sex.
                 Other commenters, in contrast, supported the proposed revisions.
                They stated the 2016 Rule was overly expansive, created an un-level
                playing field, and resulted in disincentives for issuers to participate
                in HHS-funded programs, such as offering QHPs or Medicare Advantage
                plans. This resulted in Section 1557's covering products that Congress
                explicitly excluded from the rest of the ACA, such as excepted benefits
                and short-term limited duration insurance plans. Commenters argued it
                was unlikely that Congress intended Section 1557 to regulate the same
                plans it had excluded from the ACA.
                 Response: The Department agrees with commenters who stated that the
                overly broad reach of the 2016 Rule subjected many insurance products
                that were not intended to be covered by the ACA to burdensome
                regulation, inconsistent with Congressional intent.
                 In the proposed rule, the Department stated that Section 1557 does
                not apply to short-term limited duration insurance as such, but only if
                it were offered by an entity for which all of the entity's activities
                are encompassed by Section 1557, or if such insurance received Federal
                financial assistance.\55\ Under this final rule, where short-term
                limited duration insurance (1) is offered by an entity that is not
                principally engaged in the business of providing healthcare, and (2)
                does not receive Federal financial assistance, the protections of
                Section 1557 would not apply to it. The Department will robustly
                enforce the nondiscrimination requirements for QHPs under Title I of
                the ACA, for Exchange plans established by the ACA, and for any other
                insurance plans that Section 1557 covers. The reasons that this final
                rule does not cover FEHB plans are discussed in the response to the
                next comment.
                ---------------------------------------------------------------------------
                 \55\ The Department notes by way of background that, subsequent
                to publication of the proposed rule, the U.S. District Court for the
                District of Columbia granted summary judgment for the Department,
                upholding its most recent rulemaking on short-term limited duration
                insurance. See Short-Term, Limited-Duration Insurance; Final Rule,
                83 FR 38212 (August 3, 2018). The August 2018 final rule largely
                restored the long-standing definition for short-term limited
                duration insurance to the definition that was in effect from 1997 to
                2016. The Court held that the restored definition was not arbitrary
                or capricious, finding that ``Congress clearly did not intend for
                the [ACA] to apply to all species of individual health insurance.''
                Association for Community Affiliated Plans v. U.S. Department of
                Treasury, 392 F. Supp. 3d 22, 45 (D.D.C. 2019), appeal filed July
                30, 2019.
                ---------------------------------------------------------------------------
                 Comment: The Department received comments related to the exclusion
                of employer plans and excepted benefits as a result of Sec. 92.3(c).
                Several commenters objected to the exclusion of self-funded group
                health plans under the Employee Retirement Income Security Act of 1974
                (ERISA) and the Federal Employees Health Benefits (FEHB) Program.
                Commenters argued that FEHB plans should be covered as a contract of
                insurance with the Federal government. Some suggested that employer
                group health plans, including self-funded plans, receive substantial
                Federal financial assistance in the form of favorable income tax
                treatment and thus should be covered.
                 Other commenters strongly supported excluding employer plans.
                Commenters noted that employers and group health plans are already
                subject to other Federal laws that prohibit discrimination, and that
                few employer-sponsored plans receive Federal financial assistance. They
                stated that the 2016 Rule's broad coverage exceeded statutory
                authority, encumbered the design and operation of employer group health
                plans, invited litigation regarding plan benefits, and increased the
                potential for costly new mandates, all of which were likely to increase
                healthcare costs for employers and employees alike without adding any
                additional protections against discrimination. Some commenters
                expressed support for the provision that third-party administrators of
                self-funded group health plans would no longer be subject to Section
                1557 merely because other portions of their business receive Federal
                funding.
                 Some commenters requested further clarification by recommending
                that the regulatory text at proposed Sec. 92.3(c) be revised to
                specify that other types of plans should not be considered entities
                principally engaged in the business of providing healthcare, including
                self-funded or fully insured group health plans under ERISA; self-
                funded or fully insured group health plans not covered under ERISA that
                are sponsored by either governmental employers (``government plans'')
                or certain religious employers (``church plans'' or ``denominational
                plans''); and benefit plans and programs excepted under the ACA.\56\
                ---------------------------------------------------------------------------
                 \56\ See 42 U.S.C. 300gg-91(c) (defining excepted benefits).
                ---------------------------------------------------------------------------
                 Response: The Department continues to take the position that FEHB
                plans are not covered under this rule. Even if FEHB plans were
                considered ``contracts of insurance,'' as suggested by some commenters,
                they still would not fall under the scope of this rule because the
                contract would be with the Office of Personnel Management (OPM), which
                operates the FEHB Program, not with the Department. As noted above,
                this final rule does not extend the Department's enforcement authority
                to a covered entity that is not principally engaged in the business of
                providing healthcare to the extent of its operations that do not
                receive financial assistance from the Department.
                 The Department agrees that this final rule will accomplish the
                Department's goal of reducing regulatory burden. The Department
                declines to offer further examples of non-covered entities in the
                regulatory text, as the rule's existing parameters are intended to
                broadly address different entities. To the extent that employer-
                sponsored group health plans do not receive Federal financial
                assistance and are not principally engaged in the business of providing
                healthcare (as set forth in the rule), they would not be covered
                entities. The same analysis would apply to employer-sponsored plans not
                covered by ERISA, such as self-insured church plans or
                [[Page 37174]]
                non-Federal governmental plans, as well as to excepted benefits.
                 Comment: Some commenters said that the proposed rule created
                confusion about whether QHPs are subject to the rule. Others requested
                clarification on the proposed rule's application to products offered
                through the Exchange. Others requested clarification on whether stand-
                alone dental plans and catastrophic plans, which are also sold through
                the Exchanges established under Title I, are covered under the rule.
                Another commenter requested confirmation that the proposed rule would
                not apply to individual or small-group market health insurance coverage
                that complies with the ACA but is sold outside of the Exchanges,
                regardless of whether the parent organization also offers on-Exchange
                QHPs. Others requested clarification as to how the rule would apply
                when one health insurance plan includes multiple types of enrollees,
                including subsidized Exchange enrollees, unsubsidized Exchange
                enrollees, and off-Exchange enrollees. The comments expressed concern
                that enrollees in the same plan deserved the same level of
                nondiscrimination protection and that the same standard should be
                applied.
                 Response: Health insurance products are often complex. While the
                Department provides general responses below in an attempt to clarify
                application of the rule, OCR will always engage in an individualized
                fact-based analysis when determining the extent of its jurisdiction
                over these or any other such products.
                 A QHP would be covered by the rule because it is a program or
                activity administered by an entity established under Title I (i.e., an
                Exchange), pursuant to Sec. 92.3(a)(3). A QHP could also be subject to
                Section 1557 if it were a recipient of Federal financial assistance,
                but as stated above, the premium tax credits that the Department plays
                a role in administering would no longer serve to bring an entity under
                the jurisdiction of this Section 1557 regulation.
                 Stand-alone dental plans and catastrophic plans offered through the
                Exchanges would similarly be subject to Sec. 92.3(a)(3), as these
                plans are administered by an Exchange, which is an entity established
                under Title I.
                 Regarding ACA-compliant plans sold off-Exchange, because a health
                insurance issuer is not principally engaged in the business of
                providing healthcare, its operations would be subject to this rule only
                for the portion that receives Federal financial assistance. The
                issuer's components (e.g., off-Exchange plans) that do not directly
                receive Federal financial assistance would not be subject to this rule.
                 Where a health insurance plan includes multiple types of enrollees,
                the Department would have to review the specific circumstance, but
                generally speaking, if a QHP is subject to Section 1557, this rule
                would apply consistently for all enrollees in the plan.
                 Comment: The Department received comments related to how the rule
                would apply to Medicare- and Medicaid-related products. One commenter
                asked whether the proposed limitation under Sec. 92.3(c) would mean
                that Section 1557 would no longer apply to health insurance plans
                managed through Medicare and Medicaid.
                 A few commenters requested clarification on whether the proposed
                rule would apply to Employer Group Waiver Plans (EGWPs) and Medicare
                Part D Retiree Drug Subsidy (RDS) plans, or the employers that sponsor
                the plans. Commenters argued that applying the rule to these plans
                could disincentivize employers from sponsoring them and urged that the
                plans be exempt from the rule. Alternatively, one commenter requested
                that the Department exempt employer sponsors of ``800 series'' EGWPs,
                which are offered by Medicare Advantage Organizations (MAOs) or Part D
                Plan sponsors (PDP sponsors), because the employer is not the entity
                that receives funding from HHS. Finally, some commenters objected to
                excluding Medicare Part B from the rule.
                 Response: To be covered by the rule, a particular entity would have
                to satisfy one of the applicability requirements set forth in Sec.
                92.3. Entities that receive Federal funding through the Department's
                Medicare Part C (Medicare Advantage), Medicare Part D, or Medicaid
                programs would be subject to Section 1557 as recipients of Federal
                financial assistance. This would include Medicare Advantage plans,
                Medicaid managed care plans, EGWPs, or RDS plans, to the extent that
                they receive Federal financial assistance.
                 Pending further details, an employer that does not directly
                contract with CMS but offers an ``800 series'' EGWP through a MAO or
                PDP sponsor would not appear to be subject to this rule under this
                analysis because the employer does not receive the Federal financial
                assistance; meanwhile, the health insurance issuer offering the EGWP
                would be subject to the rule for its EGWP plan, due to receipt of
                either Medicare Part C or Part D funding.
                 As for Medicare Part B, it is not Federal financial assistance.\57\
                This remains unchanged from the 2016 Rule, which also determined that
                Medicare Part B was not Federal financial assistance under Section
                1557.
                ---------------------------------------------------------------------------
                 \57\ 45 CFR pt. 80 App A, No. 121; https://www.hhs.gov/civil-rights/for-individuals/faqs/what-qualifies-as-Federal-financial-assistance/301/index.html. See also 81 FR at 31383, 31385; 84 FR at
                27863 (discussing the applicability of the rule to Medicare Part B
                and clarifying in footnote 100 that ``[t]he Department believes that
                the Federal financial assistance does not include Medicare Part B
                under the Social Security Act. See 2 CFR 200.40(c) (Uniform
                Administrative Requirement, Cost Principles, and Audit Requirements
                for Federal Awards); 45 CFR 75.502(h) (Uniform Administrative
                Requirement, Cost Principles, and Audit Requirements for HHS
                Awards).'').
                ---------------------------------------------------------------------------
                 Comment: Some commenters requested that this final rule be
                accompanied by explicit applicability guidance so that employers and
                plans could be able to ascertain if the final rule impacts their
                business.
                 Response: The Department seeks to provide sufficient clarity in
                this final rule. If OCR receives substantial questions about the rule's
                applicability after publication, OCR will consider issuing additional
                clarification, consistent with applicable law regarding issuance of
                sub-regulatory guidance.\58\
                ---------------------------------------------------------------------------
                 \58\ See, e.g., Executive Order 13892 on Promoting the Rule of
                Law Through Transparency and Fairness in Civil Administrative
                Enforcement and Adjudication, 84 FR 55239 (Oct. 9, 2019); Executive
                Order 13891 on Promoting the Rule of Law Through Improved Agency
                Guidance Documents, 84 FR 55235 (Oct. 9, 2019); U.S. Dept. of
                Justice, Memorandum of the Office of the Associate Attorney General,
                Limiting Use of Agency Guidance Documents In Affirmative Civil
                Enforcement Cases (Jan. 25, 2018), https://www.justice.gov/file/1028756/download; U.S. Dept. of Justice, Memorandum of the Office of
                the Attorney General, Prohibition on Improper Guidance Documents
                (Nov. 16, 2019), https://www.justice.gov/opa/press-release/file/1012271/download.
                ---------------------------------------------------------------------------
                e. Summary of Regulatory Changes
                 For the reasons given in the proposed rule, and having considered
                comments received, the Department finalizes the proposed Sec. 92.3,
                and repeal of Sec. 92.2 of the 2016 Rule, without change, except that,
                as discussed in an earlier section of this preamble, and after
                considering comments on the issue, the Department is not finalizing the
                proposed repeal of Sec. 92.2(c) concerning severability, but is
                retaining that provision and has moved it to Sec. 92.3(d).
                (4) Nondiscrimination Requirements in Proposed Revisions to Sec. 92.2,
                and Repeal of Sec. 92.8(d), 92.101, 92.206, 92.207, 92.209, and
                Appendix B of the 2016 Rule
                 The Department proposed to repeal Sec. 92.8(d), 92.101, 92.206,
                92.207, and Appendix B of the 2016 Rule (which includes repealing
                notice and taglines
                [[Page 37175]]
                provisions), and instead address nondiscrimination requirements in a
                new Sec. 92.2. The Department proposed to repeal provisions that made
                applicable across all protected categories those particular
                requirements, prohibitions, or enforcement mechanisms that had
                previously applied only to particular circumstances.
                 The Department requested comments on all aspects of the proposed
                rule. The Department also specifically requested comment on any
                unaddressed discrimination on the basis of race, color, or national
                origin as applied to State and Federally-facilitated Exchanges, with
                any detailed supporting information. And the Department requested
                comment on whether, and if so how, the proposed rule addresses clarity
                and confusion over compliance requirements and the rights of persons
                protected against discrimination on the basis of race, color, national
                origin, sex, disability, or age.
                 The Department received many comments on these proposed changes.
                The Department will first discuss comments concerning each of the
                grounds in Section 1557: Race, color, national origin, disability, age,
                and sex. Then other grounds of discrimination will be discussed,
                followed by assessment of claims of discriminatory conduct when
                multiple grounds of discrimination are alleged. Comments concerning
                disability and LEP protections will be addressed below in the section
                on Subpart B of the Section 1557 rule.
                a. Discrimination on the Basis of Race, Color, or National Origin
                i. Generally
                 Comment: The Department received support for its commitment to
                continued enforcement of race, color, and national origin protections.
                Commenters stated that these characteristics are clear and simple to
                distinguish, contrasting them with gender identity, which is fluid and
                more difficult to define.
                 Response: The Department appreciates the support for its continued
                commitment to the enforcement of protections against discrimination on
                the basis of race, color, and national origin. The Department agrees
                that gender identity as a category is difficult to define. This is not,
                however, the Department's reason for not viewing gender identity as a
                protected category under Section 1557. The Department enforces
                statutory prohibitions on discrimination on the basis of race, color,
                national origin, age, disability, and sex discrimination because they
                are set forth in the text of statutes incorporated into Section 1557,
                and gender identity is not set forth as a protected category in those
                statutes.
                 Comment: Commenters contended that the proposed changes, including
                repeal of Sec. 92.101 and the specific discrimination it prohibited,
                will lead to confusion among individuals and lead healthcare providers
                to discriminate based on race, color, and national origin. Commenters
                recommended that the Department retain clear, strong language
                prohibiting healthcare providers from discriminating based on race,
                color and national origin.
                 Response: This final rule's Sec. 92.2 retains clear, strong
                language prohibiting discrimination on the basis of race, color, or
                national origin. Covered entities are still required to provide the
                Department with an assurance, and, pursuant to the underlying civil
                rights regulations, to post notices, that they do not so discriminate
                and are in compliance with Federal civil rights law. If the Department
                learns of confusion among covered entities or individuals as to their
                civil rights, it will consider issuing further guidance as needed.
                 Comment: Some commenters contended that the proposed changes will
                negatively impact women of color, who (according to these commenters)
                disproportionately rely on the short-term health plans that this final
                rule does not cover, and are more likely to experience pregnancy-
                related issues that will cause them to suffer from the rollback of
                termination of pregnancy protections.
                 Response: For reasons detailed below, this final rule (a) does not
                generally apply to short-term limited duration health insurance and (b)
                only covers termination of pregnancy to the extent permitted by Title
                IX's abortion-neutrality language, as required by the relevant
                statutes. The Department will vigorously enforce the prohibitions on
                discrimination based on race or sex, including under disparate impact
                analysis with respect to race discrimination as provided for in the
                relevant Title VI regulations, but the Department remains bound by the
                limits of the statutes enacted by Congress. The Department's Office of
                Minority Health also supports outreach to diverse populations and those
                facing particularized or disproportionate health challenges.
                 Comment: One commenter expressed concern that the changes in the
                proposed rule will have a negative impact on access to health
                screenings and vaccinations for patients. The commenter stated that
                removal of nondiscrimination requirements for many health insurance
                providers will leave these populations with little recourse if health
                insurance providers rescind coverage for preventative health services.
                 Response: Because this final rule continues to commit the
                Department to robust enforcement of its prohibitions on discrimination
                on the basis of race, color, national origin, sex, age, and disability,
                the Department does not anticipate that it will impede any population's
                access to preventive care and vaccinations, which (under separate
                provisions of the ACA) must be covered without cost sharing for group
                health plans and health insurance issuers offering group or individual
                health insurance coverage.\59\
                ---------------------------------------------------------------------------
                 \59\ See 42 U.S.C. 300gg-13.
                ---------------------------------------------------------------------------
                ii. Repeal of Notice and Taglines Provisions at Sec. 92.8(d) and
                Appendix B of the 2016 Rule
                 The Department proposed to repeal Sec. 92.8(d) of the 2016 Rule,
                which required a nondiscrimination notice and taglines in all
                significant communications from covered entities, and also proposed to
                repeal the sample taglines notice in Appendix B to Part 92. 84 FR at
                27857-60. The Department stated its assumption that this will
                correspondingly ease the burden of the LEP provision in CMS regulations
                at 45 CFR 155.205(c)(2)(iii)(A), which deemed compliance with the LEP
                provisions of the Section 1557 regulation to constitute compliance with
                CMS's requirements.\60\
                ---------------------------------------------------------------------------
                 \60\ 84 CFR 27887, n. 240, and 27881.
                ---------------------------------------------------------------------------
                 The Department specifically sought comment to identify
                ``significant communications'' under the 2016 Rule sent by covered
                entities that include a notice and taglines but had not been considered
                by the analysis in the proposed rule, as well as the estimated annual
                volume of such communications. The Department also requested comment on
                which communications are significant in healthcare.
                 Comments: Some commenters stated that the removal of the 2016
                Rule's notice and taglines provisions will result in LEP beneficiaries
                having less knowledge of available language assistance services and
                that they will likely rely more on family members to provide oral
                interpretation.
                 Response: The regulations of the underlying statutes referred to in
                Section 1557 (Title VI, Section 504, Title IX, and the Age Act) have
                long mandated that covered entities provide
                [[Page 37176]]
                a notice of nondiscrimination.\61\ This final rule maintains that
                requirement. Moreover, it continues to require covered entities to
                provide taglines whenever such taglines are necessary to ensure
                meaningful access by LEP individuals to a covered program or activity.
                It removes only the unduly broad, sometimes confusing, and inefficient
                requirement that all significant communications contain taglines. This
                requirement caused significant unanticipated expenses, as discussed in
                the regulatory impact analysis (RIA) below. Moreover, as discussed
                below, Sec. 92.101 of this final rule reiterates longstanding criteria
                to help covered entities conduct an individualized assessment of their
                program and ensure meaningful access by persons with LEP, and retains
                the 2016 Rule's prohibition on covered entities' requiring an LEP
                individual to provide his or her own interpreter or relying on an
                accompanying adult to interpret or facilitate communication (except in
                limited circumstances).
                ---------------------------------------------------------------------------
                 \61\ See Title VI (45 CFR 80.6 and Appendix to Part 80), Section
                504 (45 CFR 84.8), Title IX (45 CFR 86.9), and the Age Act (45 CFR
                91.32).
                ---------------------------------------------------------------------------
                 Comment: Some commenters disagreed with the Department's proposal
                to make conforming amendments to the CMS requirements placed on Health
                Insurance Exchanges and Qualified Health Plan (QHP) issuers at 45 CFR
                155.205. These commenters argued that the CMS requirements do not rely
                on the 2016 Rule's taglines provisions, nor does the 2016 Rule prevent
                the implementation of additional requirements in more specific
                programs, such as Medicaid and Medicare. Others agreed with the
                Department's proposal, raising concerns about CMS's requirements at 45
                CFR 155.205, which state that Exchanges and QHP issues are only
                ``deemed'' in compliance with the CMS requirements ``if they are in
                compliance with'' the 2016 Rule's taglines provisions. These commenters
                argued that if the notice and taglines provisions are removed, the CMS
                compliance provision will cross-reference a repealed rule, which would
                require QHP issuers and Exchanges to comply with CMS's taglines rule
                instead. The CMS mandate for 15 taglines for the CMS list of critical
                documents is arguably as burdensome as the 2016 Rule's taglines
                provisions; therefore, these commenters argue that any benefit in
                efficiency yielded by the repeal of the 2016 Rule's taglines provisions
                would be lost for Exchanges and QHP issuers. These commenters suggest
                amending the 2016 Rule's provisions to state that there is no specific
                taglines requirement under Section 1557 and that a covered entity's
                compliance under applicable Federal and State laws will be considered
                under Section 1557's LEP meaningful access standards.
                 Response: The provision at 45 CFR 155.205(c)(2)(iii)(A) and the
                similar requirement placed on QHP issuers (see HHS Notice of Benefit
                and Payment Parameters for 2016; Final Rule, 80 FR 10750, 10788 (Feb.
                27, 2015)), have not been directly amended in this regard.
                Nevertheless, as the Department stated in the proposed rule,\62\ both
                of those requirements depend on or refer to the taglines requirements
                repealed in this final rule. As a result, covered entities are deemed
                compliant with those particular taglines requirements due to this final
                rule. Specifically, 45 CFR 155.205(c)(2)(iii)(A) sets forth taglines
                requirements and then states, ``Exchanges, and QHP issuers that are
                also subject to Sec. 92.8 of this subtitle, will be deemed in
                compliance with paragraph (c)(2)(iii)(A) of this section if they are in
                compliance with Sec. 92.8 of this subtitle.'' The Department informed
                the public of this interpretation in the proposed rule, and after
                reviewing public comments, the Department maintains the same position
                for essentially the same reason. Because this final rule repeals the
                taglines requirements of the 2016 Rule at Sec. 92.8, entities will not
                be out of compliance with those requirements, and therefore they will
                satisfy the condition of the sentence quoted above from 45 CFR
                155.205(c)(2)(iii)(A) that they not be out of compliance with taglines
                requirements in 45 CFR part 92. Although the Department did not propose
                conforming amendments to those two regulations, and therefore cannot
                finalize such amendments in this final rule, the Department will
                consider making appropriate changes to other regulations in the future.
                ---------------------------------------------------------------------------
                 \62\ 84 FR at 27881.
                ---------------------------------------------------------------------------
                 Comment: Commenters, including a health insurance issuer, noted
                that the 2016 Rule's preamble vaguely defined ``significant
                communications'' to include ``not only documents intended for the
                public . . . but also written notices to an individual, such as those
                pertaining to rights or benefits.'' 81 FR 31402. These commenters
                argued that because almost all written communications would be
                considered ``significant'' under this definition, most covered entities
                included a one- to two-page addition containing the nondiscrimination
                notice and taglines with most written communications. One health
                insurance issuer estimated sending the notice and taglines
                approximately 15 million times in 2018, or about five times for every
                individual served. One commenter stated that because the Department
                determined that the notice and taglines requirement in the 2016 Rule
                imposes a significant financial burden on covered entities, the
                Department is within its authority to rescind it, especially because of
                an executive order that limits the effectiveness of subregulatory
                guidance. Others requested that the Department issue further guidance
                on what constitutes ``significant'' documents and communications,
                instead of removing the 2016 Rule's notice and taglines provisions.
                 Response: The Department agrees with comments that stated the 2016
                Rule's notice and taglines requirements were imprecise and overly
                burdensome. The Department declines to retain those requirements while
                merely issuing more guidance on what constitute significant
                communications. First, the requirements are not mandated by statute,
                and although the 2016 Rule is a regulation and not subregulatory
                guidance, the Department has determined that its financial burden on
                covered entities was not justified by the protections or benefits it
                provided to LEP individuals. Second, the Department believes that other
                protections as finalized in this rule (and discussed below) better
                serve the language access needs of LEP individuals and, therefore, are
                more appropriate. Repeal of the notice and taglines requirements in
                this rule does not repeal all other notice and taglines requirements
                that exist under other statutes and rules.
                b. Discrimination on the Basis of Disability
                 The Department is committed under this final rule to enforce
                protections against discrimination on the basis of disability, both in
                specific provisions set forth in Sec. 92.102-92.105, and as applicable
                through the underlying Section 504 regulations, which are more broadly
                applicable under Section 1557 of the ACA. Comments on these issues are
                discussed in the section below on Subpart B of the Section 1557
                regulation.
                c. Discrimination on the Basis of Age
                 Comment: Commenters expressed concerns that the changes in the
                proposed rule will lead to discriminatory practices in health plans. In
                the absence of explicit language prohibiting health plans from
                discriminating based on age as set forth in Sec. 92.207 of the 2016
                Rule, they alleged, health plans may unlawfully
                [[Page 37177]]
                deny, cancel, or limit policies, deny or limit coverage for claims,
                impose additional cost-sharing on coverage, or use discriminatory
                marketing practices or benefit designs because of age. In particular,
                some commenters believe that health insurance plans will offer
                formularies and plan options that deny treatment for older individuals
                who generally have more health complications. For example, they say,
                this practice may already be in place with some health plans that offer
                coverage for hearing aids to children and youths but deny it to older
                adults. Some commenters said the proposed rule will lead to
                discrimination against older LGBT adults, who already have high levels
                of poverty and health disparities, and will contribute to worse health
                outcomes. Some commenters also alleged the proposed rule encourages
                unlawful discrimination against LGBT youth, who are already at
                increased risk of discrimination.
                 Response: This final rule retains clear language prohibiting
                discrimination on the basis of age, as defined in the Age Act and
                enforced through its implementing regulations, in any covered programs
                and activities, including health plan marketing and benefit design.
                Moreover, the ACA has specific provisions which limit the extent to
                which health plans offered under the ACA can charge higher premiums
                based on age, as well as specific provisions which require guaranteed
                issuance, address permissible cost sharing requirements, and establish
                standards for essential benefits and formularies.
                 The Department remains committed to vigorous enforcement of this
                prohibition on behalf of all Americans, including LGBT adults and
                youth. The Department declines to comment on specific cases outside of
                the normal enforcement process but encourages anyone who has
                experienced unlawful discrimination, including with respect to health
                plans, to file a complaint with OCR.
                 Comment: Commenters expressed concern that the proposed rule will
                lead to health plans using their benefit design to discriminate against
                individuals with chronic conditions who are more expensive to insure,
                including children and youth with serious health conditions. One
                commenter represented a 13 year old with Down syndrome who, the
                commenter said, was denied coverage by a private health insurer because
                that health insurer categorically denied coverage for individuals with
                Down syndrome.
                 Response: Many serious health conditions, including Down syndrome,
                qualify as disabilities under Section 504, which Section 1557
                incorporates. The Department will enforce vigorously Section 1557's
                prohibition on discrimination on the basis of disability against all
                covered entities, including when discrimination is alleged to have
                taken place in benefit design. As finalized, the amended Sec. 147.104
                would prohibit health insurance issuers from employing ``benefit
                designs that . . . discriminate based on an individual's race, color,
                national origin, present or predicted disability, age, sex, expected
                length of life, degree of medical dependency, quality of life, or other
                health conditions.'' The ACA also establishes requirements, applicable
                to health insurance issuers offering individual and group health
                insurance, concerning guaranteed issuance and renewal.\63\ Concerns
                about whether private health insurers are covered entities are
                addressed below in the section on this rule's scope of application.
                ---------------------------------------------------------------------------
                 \63\ See 42 U.S.C. 300gg-1, 300gg.2.
                ---------------------------------------------------------------------------
                 Comment: Some commenters contended the proposed rule will allow
                health plans to place age restrictions on certain medications, such as
                age restrictions on contraceptives for youth.
                 Response: To the extent that covered entities (including health
                plans) place restrictions based on age, OCR would assess on a case-by-
                case basis whether such restrictions violate Section 1557's
                incorporation of grounds prohibited under the Age Act. The Age Act does
                not forbid certain age distinctions in Federal, State, or local
                statutes and ordinances, or an action that reasonably takes age into
                account as a factor that is necessary to the normal operation or
                achievement of a statutory objective of a program.\64\
                ---------------------------------------------------------------------------
                 \64\ 45 CFR 90.14, 90.15.
                ---------------------------------------------------------------------------
                d. Discrimination on the Basis of Sex
                i. Generally
                 Comment: Commenters offered different points of view on the
                definition of the term ``sex,'' as this relates to the definition of
                discrimination ``on the basis of sex.''
                 A number of commenters stated that the Department had proposed a
                new definition of ``sex'' for the Section 1557 rule. Some objected that
                any reinterpretation of ``sex'' should be addressed by Congress or left
                to the courts, rather than administrative agencies. Others stated that
                the proposed regulations realign the Department's interpretation with
                several decades of Federal court decisions and with the logical
                interpretation based on the statute's plain meaning of sex (namely sex
                in its biological meaning), which until 2017 had been the consistent
                consensus of the Federal courts.
                 Some commenters said that sex is a binary reality of male and
                female, and that Title IX and Section 1557 apply this historic
                understanding of sex. Some commenters stated that there is no evidence
                in the legislative history of either Title IX or the ACA that Congress
                intended to prohibit gender identity or sexual orientation
                discrimination in Section 1557, and that the purpose of Title IX is to
                ensure women (as biologically distinct from men) equal opportunities in
                Federally funded programs and activities.\65\ Commenters said that the
                2016 Rule exceeded the Department's authority by adopting a new,
                different, or expansive definition of prohibited sex discrimination in
                its Section 1557 regulation, although Congress declined to do so when
                presented with the opportunity and instead incorporated its meaning
                from Title IX which was passed in 1972. Some commenters noted that
                Congress has repeatedly considered adding gender identity and sexual
                orientation as protected categories in nondiscrimination laws related
                to education,\66\ or to employment,\67\ or in bills that would redefine
                discrimination ``on the basis of sex'' \68\ as the 2016 Rule attempted,
                but that Congress has chosen not to do so.\69\ Where Congress has
                chosen to prohibit ``gender identity'' discrimination in other
                statutes, it added the term ``gender identity'' as a
                [[Page 37178]]
                new and separate category of prohibited grounds in addition to ``sex''
                without redefining ``sex'' itself.\70\ Other commenters said that
                reliance on legislative history is an improper method of statutory
                interpretation, and that the Supreme Court has deemed reliance on
                Congressional inaction to be inappropriate.
                ---------------------------------------------------------------------------
                 \65\ Commenters cited 118 Cong. Rec. 5808 (1972); 44 FR at
                71423.
                 \66\ See, e.g., Student Non-Discrimination Act of 2018, H.R.
                5374, 115th Congress, 2nd sess.; online at: https://www.congress.gov/115/bills/hr5374/BILLS-115hr5374ih.pdf: ``No
                student shall, on the basis of actual or perceived sexual
                orientation or gender identity . . . be excluded from participation
                in, or be denied the benefits of, or be subjected to discrimination
                under any program or activity receiving Federal financial
                assistance.''
                 \67\ See, e.g., Employment Non-Discrimination Act of 2013, S.
                815, 113th Congress, 1st sess.; online at: https://www.govtrack.us/congress/bills/113/s815/text: ``It shall be an unlawful employment
                practice for an employer--(1) to fail or refuse to hire or to
                discharge any individual, or otherwise discriminate against any
                individual . . . because of such individual's actual or perceived
                sexual orientation or gender identity . . .''
                 \68\ See, e.g., Equality Act, H.R. 5, 116th Congress, 1st sess.;
                online at: https://www.congress.gov/116/bills/hr5/BILLS-116hr5rfs.pdf; amends Civil Rights Act of 1964 ``by striking `sex,'
                each place it appears and inserting `sex (including sexual
                orientation and gender identity)' . . .''
                 \69\ See H.R. 1652, 113th Cong. (2013); S. 439, 114th Cong.
                (2015). H.R. 3185, 114th Cong. (2015); S. 1858, 114th Cong. (2015);
                H.R. 2015, 110th Cong. (2007); H.R. 2981, 111th Cong. (2009); S.
                811, 112th Cong. (2011); See H.R. 4636, 103rd Cong. (1994).
                 \70\ 18 U.S.C. 249(a)(2).
                ---------------------------------------------------------------------------
                 One commenter cited U.S. Supreme Court cases as setting forth the
                binding legal standard of sex discrimination as a binary biological
                concept. The commenter cited Tuan Anh Nguyen v. I.N.S. as rejecting an
                approach of ``[m]echanistic classification of all our differences as
                stereotypes'' because it obscures the reality that ``physical
                differences between men and women . . . are enduring,'' 533 U.S. 53, 73
                (2001), as well as Justice Ginsburg's majority opinion in United States
                v. Virginia, which held that `` `[T]he two sexes are not fungible; a
                community made up exclusively of one [sex] is different from a
                community composed of both.' '' 518 U.S. at 533 (1996).
                 Some commenters stated that changing cultural preferences should
                not be the standard for interpreting legal texts. Others analogized
                Title IX's lack of a definition of ``sex'' to the lack of a definition
                of ``race'' under the Civil Rights Act of 1964, where courts looked to
                the plain and ordinary meaning to interpret it as based on a person's
                ``family, tribe, people, or nation belonging to the same stock.'' Other
                commenters cited analyses of public meanings at the time of adoption,
                concluding that when ``gender'' was used, which was rare, it was used
                in contrast to sex: Gender referred to socially constructed roles,
                while sex, according to virtually every dictionary of the time,
                referred to biological differences between men and women.\71\ Other
                commenters stated that use of the term ``gender'' (with regard to one's
                identity) as separate from ``sex'' (with regard to one's biology) is
                relatively new and is improperly interpreted today as evidence of
                support for gender-identity legal theories in prior legal precedents or
                decades-old statutes. Some commenters asserted that at the time of the
                passage of the underlying Federal civil rights statutes, ``sex'' and
                ``gender'' were commonly used identically under Title VII, Title IX,
                and the Equal Protection Clause to refer to biological sex.\72\
                However, other commenters disagreed, and stated that historical sources
                demonstrate the variability and complexity of the concept of sex to
                include ``[t]he sum of the morphological, physiological, and behavioral
                peculiarities of living beings.''
                ---------------------------------------------------------------------------
                 \71\ Commenters cited Joanne Meyerowitz, A History of
                ``Gender,'' 113 a.m. Hist. Rev. 1346, 1353 (2008); David Haig, The
                Inexorable Rise of Gender and the Decline of Sex: Social Change in
                Academic Titles, Archives of Sexual Behavior 1945-2001 (Apr. 2004);
                Sari L. Reisner, et al., ``Counting'' Transgender and Gender-
                Nonconforming Adults in Health Research, Transgender Studies
                Quarterly 37 (Feb. 2015); New Oxford Am. Dictionary 721-22, 1600 (3d
                ed. 2010).
                 \72\ See Glenn v. Brumby, 663 F.3d 1312, 1315 (11th Cir. 2011)
                (citing City of Cleburne v. Cleburne Living Ctr., Inc., 473 U.S.
                432, 440-41 (1985). (``In describing generally the contours of the
                Equal Protection Clause, the Supreme Court noted its application to
                this issue, referencing both gender and sex, using the terms
                interchangeably . . .'').
                ---------------------------------------------------------------------------
                 Some commenters stated that the terms male or female apply to
                everyone. Commenters stated that the ``sex'' of an organism is a clear,
                provable, objective, identifiable, biological, and binary reality
                according to relevant textbooks, studies, and articles from various
                specialties in the scientific community, including embryology,
                genomics, psychiatry, clinical anatomy, neuropsychology, developmental
                biology, genetics, endocrinology, neuropsychiatry, radiology,
                organismic and evolutionary biology, neuropharmacology, pediatrics, and
                pathology.\73\ Healthcare providers stated that the reality of sex, as
                male or female, can be identified through advanced chromosomal testing
                such as karyotyping or simple genital identification at birth in
                roughly 99.98% of cases, leaving the remaining 0.02% as diagnoses with
                intersex or ambiguous conditions. Others stated that delineating a
                binary division on the basis of reproductive organs reflected an
                outdated paradigm and was not universally descriptive of transgender,
                transitioning, androgynous, intersex, two-spirit, or questioning
                individuals.
                ---------------------------------------------------------------------------
                 \73\ Commenters cited texts including, e.g., T.W. Sadler, Ph.D.,
                Langman's Medical Embryology (Philadelphia: Lippincott Williams &
                Wilkins, 2004), 40; William J. Larsen, Ph.D., Human Embryology (New
                York: Churchill Livingstone, 2001), 519; Keith L. Moore, Ph.D., DSc,
                and T.V.N. Persaud, M.D., Ph.D. DSc, FRCPath., The Developing Human:
                Clinically Oriented Embryology (Philadelphia: Saunders/Elsevier,
                2003), 35; Maureen L. Condic, Ph.D. and Samuel B. Condic, Ph.D.,
                ``Defining Organisms by Organization,'' National Catholic Bioethics
                Quarterly 5, no. 2 (Summer 2005): 336; Lawrence S. Mayer, Ph.D., and
                Paul R. McHugh, M.D., ``Sexuality and Gender Findings from the
                Biological, Psychological, and Social Sciences,'' New Atlantis 50
                (Fall 2016): 89; Scott F. Gilbert, Ph.D. Developmental Biology
                (Sunderland, Mass.: Sinauer Associates, 2016), 519-20; and William
                J. Larsen, Ph.D., Human Embryology (New York: Churchill Livingstone,
                2001), 307; Nichole Rigby, M.A. and Rob J. Kulathinal, Ph.D.,
                ``Genetic architecture of sexual dimorphism in humans,'' J. of
                Cellular Physiology 230, no. 10 (2015): 2305; Jonathan C.K. Wells,
                Ph.D., ``Sexual dimorphism of body composition,'' Best Practice &
                Research: Clinical Endocrinology & Metabolism 21 (2007): 415; Larry
                Cahill, Ph.D., ``His Brain, Her Brain,'' Scientific American,
                October 1, 2012; Larry Cahill, Ph.D. ``A Half-Truth Is a Whole Lie:
                On the Necessity of Investigating Sex Influences on the Brain,''
                Endocrinology 153 (2012): 2542; Madhura Ingalhalikar, Ph.D., et al.,
                ``Sex differences in the structural connectome of the human brain,''
                Proceedings of the National Academy of Sciences 111 (January 2014):
                823-28.
                ---------------------------------------------------------------------------
                 Some commenters stated that removal of a regulatory definition of
                ``sex'' leaves the regulation ambiguous, and the 2016 Rule was
                justified in clarifying by adding a definition that included gender
                identity and termination of pregnancy. Other commenters stated that the
                public widely understands the state of being either male or female, as
                determined by one's chromosomes or genetics, which leaves no ambiguity.
                 Response: Because Section 1557 incorporates Title IX's prohibition
                on discrimination ``on the basis of sex,'' it presupposes that the
                executive and judicial branches can recognize the meaning of the term
                ``sex.'' This final rule repeals the 2016 Rule's definition of ``on the
                basis of sex,'' but declines to replace it with a new regulatory
                definition. See 84 FR at 27857. Instead, the final rule reverts to, and
                relies upon, the plain meaning of the term in the statute.
                 ``Sex'' according to its original and ordinary public meaning
                refers to the biological binary of male and female that human beings
                share with other mammals. As noted in briefs recently submitted by the
                Federal government to the Supreme Court, discrimination on the basis of
                sex means discrimination on the basis of the fact that an individual is
                biologically male or female.\74\ Several commenters reference various
                sources of legislative history: That of Title IX, of Congress's
                decision to add protections on the basis of sexual orientation and
                gender identity to other statutes alongside protections on the basis of
                sex, and of Congress's repeated refusal to add those protections in
                other cases.\75\ These sources support the plain
                [[Page 37179]]
                meaning of Title IX, but are not the only source of support for the
                Department's understanding of the meaning of the word ``sex.''
                Contemporaneous dictionaries and common usage make clear that ``sex''
                in Title IX means biological sex.\76\ Even today, the article on gender
                dysphoria in the Diagnostic and Statistical Manual of Mental Disorders,
                Fifth Edition defines ``sex'' to ``refer to the biological indicators
                of male and female (understood in the context of reproductive
                capacity), such as in sex chromosomes, gonads, sex hormones, and
                nonambiguous internal and external genitalia.'' \77\ The term
                ``gender'' may sometimes be ambiguous. However, neither Title IX nor
                Section 1557 uses that term, and the ordinary public meaning of the
                term ``sex'' in Title IX is unambiguous. In order to avoid ambiguities
                associated with the term ``gender,'' the Department's regulations and
                guidance have, where relevant, distinguished sex (in its biological
                meaning) from gender, gender identity, or gender expression.\78\
                ---------------------------------------------------------------------------
                 \74\ Bostock v. Clayton Cty. Bd. of Commissioners, 2019 WL
                4014070 at *25 (U.S. 2019) (Brief for the United States as Amicus
                Curiae Supporting Affirmance in No. 17-1618 (Bostock v. Clayton Cty.
                Bd. of Commissioners) and Reversal in No. 17-1623 (Altitude Express
                Inc. v. Zarda)); Statement of Interest for DOJ, Soule v. Conn. Ass'n
                of Schools, 3:20-cv-00201-RNC (D. Conn., filed March 27, 2020) at 4-
                5 (``When Congress enacted Title IX in 1972, the `ordinary,
                contemporary, common meaning' of `sex' was biological sex. . . .
                Title IX consistently uses `sex' as a binary concept capturing only
                two categories: Male and female.'').
                 \75\ Examples of bills where Congress chose not to enact
                prohibitions on discrimination on the basis of sexual orientation or
                gender identity include: The Employment Non-Discrimination Act
                (ENDA), which has been introduced ten times in the U.S. House of
                Representatives but has never proceeded out of committee: H.R. 4636
                (103rd Cong. 1994); H.R. 1863 (104th Cong. 1995); H.R. 1858 (105th
                Cong. 1997); H.R. 2355 (106th Cong. 1999); H.R. 2692 (107th Cong.
                2001); H.R. 3285 (108th Cong. 2003); H.R. 2015 (110th Cong. 2007);
                H.R. 2981 (111th Cong. 2009); H.R. 1397 (112th Cong. 2011); H.R.
                1755 (113th Cong. 2013). Similarly, the Equality Act has been
                introduced in three successive sessions of Congress; it did not
                proceed out of committee in the 114th and 115th Congresses, and it
                passed the House of Representatives on May 17, 2019. See H.R. 3185
                (114th Cong. 2015); S. 1828 (114th Cong. 2015); H.R. 2282 (115th
                Cong. 2017); S. 1006 (115th Cong. 2017); H.R. 5 (116th Cong.)
                (introduced Mar. 3, 2019).
                 \76\ See New Oxford Am. Dictionary 721-22, 1600 (3d ed. 2010).
                Some Federal courts have gone farther, using the legislative history
                to show that ``Congress never considered nor intended'' for sex
                under Title VII (which is often used to interpret Title IX) to apply
                to ``anything other than the traditional concept of sex,'' and that
                coverage for a concept such as transgender status ``surely'' would
                have been mentioned in the legislative history had Congress intended
                such an ``all-encompassing interpretation.'' The Department finds
                the analysis in these Court decisions persuasive, but declines to
                rely on their reasoning. See Ulane v. Eastern Airlines Inc., 742 F.
                2d 1081, 1085 (7th Cir. 1984) (analyzing ``The total lack of
                legislative history supporting the sex amendment coupled with the
                circumstances of the amendment's adoption''); see also Voyles v.
                Ralph K. Davies Medical Center, 403 F. Supp. 456, 457 (N.D. Cal.
                1975), aff'd, 570 F.2d 354 (9th Cir. 1978) (finding a ``void'' in
                the legislative history and concluding that Congress's ``paramount,
                if not sole, purpose in banning employment practices predicated upon
                an individual's sex was to prohibit conduct which, had the victim
                been a member of the opposite sex, would not have otherwise
                occurred. Situations involving transsexuals, homosexuals or bi-
                sexuals were simply not considered.'').
                 \77\ American Psychiatric Ass'n, Diagnostic and Statistical
                Manual of Mental Disorders, 5th ed. (Arlington, VA: American
                Psychiatric Ass'n, 2013), 451-59.
                 \78\ See 45 CFR 411.5; also 79 FR 77771, 84 FR 27854. See NIH,
                Office of Research on Women's Health, ``Sex & Gender,'' https://orwh.od.nih.gov/sex-gender (``NIH is committed to improving health
                by supporting the rigorous science that drives medical advances.
                Sex/gender influence health and disease, and considering these
                factors in research informs the development of prevention strategies
                and treatment interventions for both men and women. `Sex' refers to
                biological differences between females and males, including
                chromosomes, sex organs, and endogenous hormonal profiles. `Gender'
                refers to socially constructed and enacted roles and behaviors which
                occur in a historical and cultural context and vary across societies
                and over time. . . . With continuous interaction between sex and
                gender, health is determined by both biology and the expression of
                gender.'').
                 For these reasons, in general throughout this document the
                Department prefers to use simply the term ``sex'' because the plain,
                ordinary meaning of ``sex'' is already biological, so it is
                generally redundant to use the term ``biological sex.'' Where the
                Department uses the term ``biological sex,'' or similarly
                ``biological male'' or ``biological female,'' it does so merely to
                emphasize this point and for the purposes of clarity in particular
                contexts, and not to imply that there is a distinction between
                biological sex and sex under the plain meaning of the term.
                ---------------------------------------------------------------------------
                 Some commenters challenge the Department's approach by pointing to
                medical conditions that they refer to as ``intersex.'' The term refers
                to rare medical conditions that the medical literature, since 2006, has
                preferred to call ``disorders of sexual development'' (DSD).\79\ DSD
                are estimated to be present in 0.0167%-0.022% of the population. More
                importantly, DSD are ``congenital conditions in which development of
                chromosomal, gonadal, or anatomic sex is atypical.'' \80\ This medical
                definition refers to, and presupposes, the ordinary biological and
                binary meaning of ``sex,'' just as the definition of any medical
                disorder presupposes an understanding of healthy baseline
                functionality.
                ---------------------------------------------------------------------------
                 \79\ R.L.P. Romao, J.L. Pippi Salle, and D.K. Wherett, ``Update
                on the Management of Disorders of Sex Development,'' Pediatric
                Clinics of North America 59 (2012), 853-69; I.A. Hughes, ``Disorders
                of Sex Development: A New Definition and Classification,'' Best
                Practice & Research Clinical Endocrinology & Metabolism 22:1 (2008),
                119-34.
                 \80\ A. Rawal and P. Austin, ``Concepts and Updates in the
                Evaluation and Diagnosis of Common Disorders of Sexual
                Development,'' Current Urology Reports 16:83 (2015), 1-9; I. Hughes
                et al., ``Consequences of the ESPE/LWPES guidelines for diagnosis
                and treatment of disorders of sex development,'' Best Practice &
                Research Clinical Endocrinology & Metabolism 21:3 (2007), 351-65;
                P.A. Lee et al., ``Consensus Statement on Management of Intersex
                Disorders,'' Pediatrics 118:2 (2006), e488-500.
                ---------------------------------------------------------------------------
                 Title IX,\81\ along with its implementing regulations,\82\
                consistently understands ``sex'' to refer to the biological binary
                categories of male and female only.\83\ The Department of Justice has
                recently noted that ``[i]f the term `sex' in Title IX included `gender
                identity'--which, according to the American Psychiatric Association,
                may include `an individual's identification as . . . some category
                other than male or female,' Diagnostic and Statistical Manual of Mental
                Disorders Fifth Edition 451 (2013) (emphasis added)--then multiple
                Title IX provisions would make little sense.'' \84\ Many comments on
                the 2019 NPRM assume that Section 1557's protection against
                discrimination ``on the basis of sex'' covers women's health issues
                including pregnancy, uterine cancer, and prenatal and postpartum
                [[Page 37180]]
                services. That assumption is correct: These issues are protected under
                Section 1557 because of the ordinary and biological meaning of ``sex.''
                ---------------------------------------------------------------------------
                 \81\ See 42 U.S.C. 1681(a)(2)(``both sexes''), (a)(2) (``one
                sex'' and ``other sex''), (a)(6)(B) (``Men's'' and ``Women's''),
                (a)(6)(B) (``Boy'' and ``Girl''); (a)(7)(A) (``Boys'' and
                ``Girls''), (a)(7)(B)(i) (``Boys'' and ``Girls''), (a)(8) (``father-
                son'' ``mother-daughter''), and (a)(8) (``one sex'' and ``other
                sex''). See also 42 U.S.C. 1681(a)(2)(6)(``fraternity'' and
                ``sorority'').
                 \82\ See language such as ``male and female,'' ``both sexes,''
                ``each sex,'' ``one sex . . . the other sex,'' and ``boys'' and
                ``girls,'' at 45 CFR 86.2(s), 86.7, 86.17(b)(2), 86.21(c)(4),
                86.31(c), 86.32(b)(2) and (c)(2), 86.33, 86.37(a)(3), 86.41(b) and
                (c), 86.55(a), 86.58(a) and (b), 86.60(b), and 86.61. See similarly
                Department of Education Title IX regulation at 34 CFR 106.2(s),
                106.7, 106.17(b)(2), 106.21(c)(4), 106.31(c), 106.32(b)(2) and
                (c)(2), 106.33, 106.37(a)(3), 106.41(b) and (c), 106.55(a),
                106.58(a) and (b), 106.60(b), and 106.61; Department of Justice
                Title IX regulation at 28 CFR 54.105, 54.130, 54.230(b)(2),
                54.235(b)(3), 54.300(c)(4), 54.400(c), 54.405(b)(2) and (c)(2),
                54.410, 54.430(a)(3), 54.450(b) and (c)(2), 54.520(a), 54.535(a) and
                (b), 54.545(b), and 54.550. See also DOJ Coordination and Compliance
                Division, Title IX Regulations by Agency, https://www.justice.gov/crt/fcs/Agency_Regulations#2.
                 \83\ Federal courts have also made this observation. See, e.g.,
                Doe v. Boyertown Area Sch. Dist., 897 F.3d 518, 522 (3d Cir. 2018)
                (```Sex' is defined as `the anatomical and physiological processes
                that lead to or denote male or female.' Typically, sex is determined
                at birth based on the appearance of external genitalia.''); Hively
                v. Ivy Tech Cmty. Coll., 853 F.3d 339, 362 (7th Cir. 2017) (``[i]n
                common, ordinary usage in 1964--and now, for that matter--the word
                `sex' means biologically male or female.'') (Sykes, J., dissenting)
                (emphasis in original); cf. id. at 357 (``we, who are judges rather
                than members of Congress, are imposing on a half-century-old statute
                a meaning of `sex discrimination' [to include sexual orientation]
                that the Congress that enacted it would not have accepted.'')
                (Posner, J., concurring); G.G. ex rel Grimm v. Gloucester Cnty. Sch.
                Bd., 822 F.3d 709, 736 (4th Cir. 2016) (``Title IX was enacted in
                1972 and the regulations were promulgated in 1975 and readopted in
                1980, and during that time period, virtually every dictionary
                definition of `sex' referred to the physiological distinctions
                between males and females, particularly with respect to their
                reproductive functions.'') (Niemeyer, J., dissenting); Statement of
                Interest for DOJ, Soule v. Connecticut Association of Schools, 3:20-
                cv-00201-RNC (D. Conn., filed March 27, 2020) at 5 (``Other
                provisions of Title IX employ ``sex'' as a binary term, and thus
                provide further confirmation that the prohibition on ``sex''
                discrimination does not extend to discrimination on the basis of
                transgender status or gender identity.''); Franciscan All., Inc. v.
                Burwell, 227 F. Supp. 3d 660, 687 (N.D. Tex. 2016) (``the meaning of
                sex unambiguously refers to the biological and anatomical
                differences between male and female students as determined at their
                birth,'' quoting Texas v. United States, 201 F. Supp. 3d 810, 833
                (N.D. Tex. 2016)); Johnston v. Univ. of Pittsburgh of Commw. Sys. of
                Higher Educ, 97 F. Supp. 3d 657, 676 (W.D. Pa. 2015) (``[o]n a plain
                reading of the statute, the term `on the basis of sex' in Title IX
                means nothing more than male and female, under the traditional
                binary conception of sex consistent with one's birth or biological
                sex'').
                 \84\ Statement of Interest for DOJ, Soule v. Conn. Ass'n of
                Schools, 3:20-cv-00201-RNC (D. Conn., filed March 27, 2020) at 5.
                ---------------------------------------------------------------------------
                 Prior to the ACA, OCR itself had always applied Title IX in its
                enforcement actions using the biological binary meaning of sex.\85\
                Recently, OCR has resolved a number of Section 1557/Title IX cases of
                discrimination against women in healthcare programs and activities
                funded by the Department, again relying on a biological understanding
                of sex.\86\ The 2016 Rule itself presupposed the biological meaning of
                sex when it permitted ``sex-specific'' health programs that are
                ``restricted to members of one sex,'' when it incorporated
                ``termination of pregnancy'' into discrimination on the basis of sex,
                and when it referred repeatedly to ``sex assigned at birth.'' \87\
                ---------------------------------------------------------------------------
                 \85\ In the 2015 NPRM, the earliest record of the Department's
                new understanding of sex discrimination cited was an OCR letter
                dated 12 July 2012. 80 FR 54176.
                 \86\ U.S. Department of Health and Human Services, ``HHS Office
                for Civil Rights Enters Into Agreement with Oklahoma Nursing Home to
                Protect Patients with HIV/AIDS from Discrimination'' (2018), https://www.hhs.gov/about/news/2017/09/08/hhs-office-for-civil-rights-enters-into-agreement-with-oklahoma-nursing-home.html; ``OCR works
                with DOJ to ensure Federally funded medical center provides
                communication services for deaf and hard of hearing patients''
                (2018), https://www.hhs.gov/about/news/2017/12/20/ocr-works-with-doj-to-ensure-Federally-funded-medical-center-provides-communication-services-for-deaf-and-hard-of-hearing-patients.html;
                ``HHS OCR Secures Agreement with MSU to Resolve Investigation into
                Sexual Abuse by Larry Nassar'' (2019), https://www.hhs.gov/about/news/2019/08/12/hhs-ocr-secures-agreement-msu-resolve-investigation-sexual-abuse-larry-nassar.html (requiring chaperone policies where
                patients can request a chaperone of the same sex, meaning biological
                sex, during sensitive physical examinations).
                 \87\ See 81 FR 31384, 31387, 31406, 31408-09, 31428, 31429,
                31435, 31436, 31467, 31470, 31471, 31472.
                ---------------------------------------------------------------------------
                 Supreme Court case law on Title IX has consistently presupposed the
                biological and binary meaning of ``sex.'' \88\ Even when some lower
                courts have recently extended Title VII or Title IX protections ``on
                the basis of sex'' to encompass gender identity, they have done so only
                by presupposing the ordinary public meaning of ``sex'' as a biological
                binary reality. In Whitaker v. Kenosha Unified Sch. Dist., for example,
                the Seventh Circuit stated: ``Here, the School District's policy cannot
                be stated without referencing sex, as the School District decides which
                bathroom a student may use based upon the sex listed on the student's
                birth certificate. This policy is inherently based upon a
                sex[hyphen]classification and heightened review applies.'' \89\
                Likewise, in Harris Funeral Homes, the Sixth Circuit stated: ``Here, we
                ask whether Stephens would have been fired if Stephens had been a woman
                who sought to comply with the women's dress code. The answer quite
                obviously is no. This, in and of itself, confirms that Stephens's sex
                impermissibly affected Rost's decision to fire Stephens.'' \90\ In
                other words, Stephens ``quite obviously'' is not ``a woman'' because
                ``Stephens's sex'' is male.\91\
                ---------------------------------------------------------------------------
                 \88\ See, e.g., Nat'l Collegiate Athletic Ass'n v. Smith, 525
                U.S. 459, 464 (1999) (Title IX claim based on allegation ``that the
                NCAA discriminates on the basis of sex by granting more waivers from
                eligibility restrictions to male than female postgraduate student-
                athletes''); Cannon v. Univ. of Chicago, 441 U.S. 677, 680 (1979)
                (Title IX claim based on allegation that plaintiff's ``applications
                for admission to medical school were denied . . . because she is a
                woman'').
                 \89\ 858 F.3d 1034, 1051 (7th Cir. 2017).
                 \90\ Equal Emp't Opportunity Comm'n v. R.G. & G.R. Harris
                Funeral Homes, 884 F.3d 560 (6th Cir. 2018), 575. See also certain
                passages during oral argument on appeal at the U.S. Supreme Court,
                e.g.: ``here, Ms. Stephens, was being treated differently because of
                her sex. . . .Yes, if she had not been a--if she had not been
                assigned at birth the sex that she was assigned at birth, she would
                have been treated differently'' (Kagan, J., Transcript of Oral
                Argument at 41, R.G. & G.R. Harris Funeral Homes, Inc. v. E.E.O.C.,
                139 S. Ct. 1599 (2019) (No. 18-107), https://www.supremecourt.gov/oral_arguments/argument_transcripts/2019/18-107_4gcj.pdf); See also
                Mr. Cole, counsel for respondents at oral argument, Id. at 4-5:
                ``None of [our] arguments ask this Court to redefine or, in Judge
                Posner's words, update sex. They assume, arguendo, that sex means at
                a minimum sex assigned at birth based on visible anatomy or
                biological sex.'' Id. at 28: ``[O]ur argument rests on text meaning,
                at a minimum, sex assigned at birth or biological sex, and everybody
                agrees-- . . . [we are] asking you to interpret the statute as it is
                written and as everybody agrees it applies to sex assigned at
                birth.''
                 \91\ Harris 884 F.3d at 575. It is true that the Harris court
                referred to Stephens with female pronouns throughout the rest of its
                ruling, but it appeared to do so based on its concept of gender
                identity, not of sex. Had the Harris court employed female pronouns
                in the quoted passage, it would have visibly undermined the basis of
                its Title IX analysis.
                ---------------------------------------------------------------------------
                 The Department does not deny that some courts have caused confusion
                as to the meaning of sex in civil rights law. Conflicting views in the
                lower courts, however, do not preclude the Department, consistent with
                the position of the U.S. government, as set forth in briefs filed in
                the Supreme Court, from returning to its decades-long practice of
                conforming to the original and ordinary public meaning of ``sex'' in
                Title IX, a meaning that continues to be presupposed even in the same
                rulings that have caused this confusion.
                 Some lower courts have recently held that discrimination ``on the
                basis of sex'' encompasses gender identity or sexual orientation even
                when ``sex'' is understood in its ordinary, biological, and binary
                sense. These views will be addressed below in the relevant subsections.
                 Comment: Some commenters argued that the proposed rule would be
                inconsistent with the purposes of the ACA; that the weight of law
                recognizes sexual orientation and gender identity as forms of sex
                discrimination; and that the proposed rule would undermine Congress's
                intent to expand access to healthcare and healthcare coverage.
                Commenters emphasized that it is unacceptable for a healthcare facility
                to deny medical care to a patient based on the patient's sexual
                orientation or transgender status.
                 Response: The Department does not condone the unjustified denial of
                needed medical care to anyone, and believes that everyone, regardless
                of gender identity or sexual orientation, should be treated with
                dignity and respect. The Department must interpret Congress's purpose
                in passing the ACA by reading that statute's plain text. The ACA sought
                to expand access to healthcare and healthcare coverage through some
                means but not others: in particular, Congress saw fit to incorporate
                into the ACA certain nondiscrimination protections, and not others. For
                example, in the unlikely event that a healthcare provider were to deny
                services to someone based solely on his or her political affiliation,
                the Department would not be able to address such denial of care under
                Section 1557. Under this final rule, OCR is committed to no less than
                full enforcement of the prohibitions on discrimination that Congress
                included in Section 1557, without exceeding the statutory text. Unlike
                other bases of discrimination, the categories of gender identity and
                sexual orientation (as well as political affiliation) are not set forth
                in those statutes.\92\
                ---------------------------------------------------------------------------
                 \92\ The Department responds below to comments with respect to
                sexual orientation and gender identity specifically.
                ---------------------------------------------------------------------------
                 Comment: Some insurers stated that they already took steps to come
                into compliance with prohibitions related to gender identity and
                termination of pregnancy in their plans under the 2016 Rule, and that
                they will incur burdens to change their plans. Other commenters stated
                that the 2016 Rule created burdens that, if unrelieved, would encumber
                their day-to-day affairs and limit their ability to provide healthcare
                services for their patients or healthcare coverage for their employees.
                 Response: As discussed in the Regulatory Impact Analysis below,
                this rule removes certain requirements, without requiring providers to
                incur new burdens related to those requirements. Whether or not the
                Department revises the regulation, the past expenditures incurred by
                insurers and other commenters to come into
                [[Page 37181]]
                compliance with the 2016 Rule are ``sunk costs'' that cannot be
                recovered. With the finalization of this rule, insurers have the
                option--as they have had since December 31, 2016--of providing such
                coverage or not. Presumably some insurers will maintain coverage
                consistent with the 2016 Rule's requirements and some will not. The
                final rule also does not alter the status quo, and thus does not impose
                burdens in this regard, because, independent of the finalization of
                this rule, the 2016 Rule's provisions on gender identity and
                termination of pregnancy have been vacated by a final order and
                decision of a federal court.
                 Comment: Commenters expressed concern that the proposed rule would
                result in lack of information about gender transition-related services
                or termination of pregnancy, leaving patients without information about
                different surgical procedures and prescription options, and in danger
                of harm. Some argued that women, members of the LGBT community, people
                with disabilities, people with LEP, and racial minorities need
                additional specific protections because they will face greater burdens
                accessing healthcare due to ``intersectionality'' theories. Others,
                however, said it was not appropriate or reflective of current civil
                rights law to analogize sexual orientation or gender identity to race
                or other protected categories.
                 Some commenters argued that the 2016 Rule had decreased LGBT
                patients' fears of discrimination, that the proposed rule will lead to
                discrimination against them (including by States, providers,
                marketplaces, agents, and brokers), and that this will increase their
                health disparities, mainly via poorer quality of care, lack of access
                to willing providers especially in rural areas, postponed care
                including preventive care, increased healthcare and insurance costs,
                and impediments to HIV patients' access to medication. Commenters said
                the rule would undermine the President's goal of eradicating HIV.
                Commenters relied on national and statewide reports and studies
                highlighting harm faced by LGBT people due to inadequate healthcare,
                including an increase in substance abuse; worsening psychiatric
                disorders; untreated depression leading to suicide; and higher rates of
                AIDS, HIV and other STIs, cancer, and behavioral health issues. These
                commenters also argued the proposed rule would permit LGBT people to
                suffer discrimination and hence stigmatic injury, which could also
                deter them from disclosing their LGBT status to their physicians and
                seeking proper care. Commenters alleged high rates of mental conditions
                (e.g., depression),\93\ behavioral conditions (e.g., substance use
                disorder),\94\ developmental conditions (e.g., autism, learning
                disabilities), and physical conditions (e.g., HIV, heart disease) among
                the LGBT population. Commenters also expressed concerns about lack of
                communication and consent between providers and patients, and alleged
                that the risk of discrimination is heightened in vulnerable
                populations, including persons with developmental disabilities, persons
                with LEP, elderly patients with diminished capacity, and those who rely
                on surrogates or guardians for making medical decisions on their
                behalf. Others stated that OCR does not have authority to protect all
                forms of discrimination that may negatively impact people, but that it
                must act within its statutory authority.
                ---------------------------------------------------------------------------
                 \93\ Commenters cited Remafedi G, French S, Story M, et al., The
                Relationship Between Suicide Risk and Sexual Orientation: Results of
                a Population-Based Study. Am J Public Health. 1998;88(1):57-60;
                McLaughlin KA, Hatzenbuehler ML, Keyes KM. Responses to
                Discrimination and Psychiatric Disorders Among Black, Hispanic,
                Female, and Lesbian, Gay, and Bisexual Individuals. Am J Public
                Health. 2010;100(8):1477-84.
                 \94\ Commenters cited Banez GE, Purcell DW, Stall R, et al.,
                Sexual Risk, Substance Use, and Psychological Distress in HIV
                Positive Gay and Bisexual Men Who Also Inject Drugs. AIDS. 2005;19
                (suppl. 1):49-55.
                ---------------------------------------------------------------------------
                 Response: The Department is concerned with the health of all
                Americans. It acts to the fullest extent of its statutory authority in
                its efforts to improve the health and wellbeing of all. Under its civil
                rights authority, it enforces Federal laws requiring nondiscrimination
                on specified grounds, which in the case of Section 1557 are race,
                color, national origin, sex, age, and disability. When OCR receives a
                claim alleging multiple grounds of prohibited discrimination, the
                Department analyzes the elements of each claim according to the statute
                applicable to that ground.
                 Consistent with the text of the ACA and, in this case, the
                underlying civil rights statutes incorporated into the ACA, the
                Department seeks, wherever possible, to remove barriers to healthcare.
                Those barriers include regulations that impede providers' ability to
                offer healthcare by interfering with their conscientious medical
                judgments or imposing unnecessary cost burdens on them. By removing
                such provisions from the 2016 Rule, the Department hopes to increase
                the availability of healthcare to all populations.
                 As a matter of policy, the Department recognizes and works to
                address barriers to treatment caused by stigma about depression,
                anxiety, substance use disorder, and other comorbid mental and
                behavioral health conditions.\95\ With regard to HIV, this final rule
                does not alter or affect the longstanding Federal protections against
                discrimination for individuals with HIV: Section 504, and hence also
                this final rule, prohibits discrimination on the basis that an
                individual has HIV.\96\ OCR continues to pursue major enforcement
                actions under its authorities \97\ and to provide the public guidance
                \98\ to protect the rights of persons with HIV or AIDS. HHS remains
                committed to ensuring that those living with HIV or AIDS receive full
                protection under the law, in accordance with full implementation of the
                President's National HIV/AIDS Strategy.\99\
                ---------------------------------------------------------------------------
                 \95\ See, e.g., Pain Management Task Force, ``Pain Management
                Best Practices, Fact Sheet on Stigma'' (Aug. 13, 2019), https://www.hhs.gov/sites/default/files/pmtf-fact-sheet-stigma_508-2019-08-13.pdf (``Compassionate, empathetic care centered on a patient-
                clinician relationship is necessary to counter the suffering of
                patients . . . . Patients with painful conditions and comorbidities,
                such as anxiety, depression or substance use disorder (SUD) face
                additional barriers to treatment because of stigma.'').
                 \96\ See 29 U.S.C. 705(20) (incorporating ADA definition of
                disability into Section 504); 42 U.S.C. 12102(1)-(3); 28 CFR
                35.108(d)(2)(iii)(J).
                 \97\ See, e.g., ``HHS Office for Civil Rights Secures Corrective
                Action and Ensures Florida Orthopedic Practice Protects Patients
                with HIV from Discrimination'' (Oct. 30, 2019), https://www.hhs.gov/about/news/2019/10/30/hhs-ocr-secures-corrective-action-and-ensures-fl-orthopedic-practice-protects-patients-with-hiv-from-discrimination.html; ``HHS Office for Civil Rights Enters Into
                Agreement with Oklahoma Nursing Home to Protect Patients with HIV/
                AIDS from Discrimination'' (Sept. 8, 2017), https://www.hhs.gov/about/news/2017/09/08/hhs-office-for-civil-rights-enters-into-agreement-with-oklahoma-nursing-home.html.
                 \98\ See OCR, ``Know the Rights That Protect Individuals with
                HIV and AIDS,'' https://www.hhs.gov/sites/default/files/ocr/civilrights/resources/factsheets/hivaids.pdf; OCR, ``Protecting the
                Civil Rights and Health Information Privacy Rights of People Living
                with HIV/AIDS,'' https://www.hhs.gov/civil-rights/for-individuals/special-topics/hiv/index.html.
                 \99\ See ``Ending the HIV Epidemic: A Plan for America,''
                https://www.hiv.gov/Federal-response/ending-the-hiv-epidemic/overview.
                ---------------------------------------------------------------------------
                 Regarding commenters' worries about informed consent, this final
                rule does not repeal any informed consent requirements. Besides many
                relevant State laws,\100\ CMS regulations also
                [[Page 37182]]
                require, as a condition of participation in Medicare, that patients (or
                their legal surrogate) have the right to make informed decisions, the
                right to surgical informed consent policies,\101\ and the right to
                properly executed informed consent forms.\102\ Most States' malpractice
                laws address negligent failure to communicate risks and benefits of
                medical treatment options. Basic elements of informed consent with
                respect to participation in a clinical trial, for example, include: (1)
                Providing information needed to make an informed decision; (2)
                facilitating the understanding of what has been disclosed; and (3)
                promoting the voluntariness of the decision about whether or not to
                participate.\103\
                ---------------------------------------------------------------------------
                 \100\ See, e.g., Alaska Stat. Sec. 09.55.556(a); Ark. Code Ann.
                Sec. 16-114-206; Del. Code Ann. tit. 18, Sec. 6852; Ga. Code Ann.
                Sec. 31-9-6.1; Haw. Rev. Stat. Sec. 671-3; Idaho Code Ann. Sec.
                39-4304; Ind. Code Sec. 16-36-1.5-7; Ky. Rev. Stat. Ann. Sec.
                304.40-320; La. Rev. Stat. Ann. Sec. 40:1299.40; Me. Rev. Stat.
                Ann. tit. 24 Sec. 2905; Neb. Rev. Stat. Sec. 44-2816; Nev. Rev.
                Stat. Sec. 449.710; N.Y. Pub. Health Law Sec. 2805-d; N.C. Gen.
                Stat. Sec. 90-21.13; Or. Rev. Stat. Sec. 677.097; 40 Pa. Cons.
                Stat. Sec. 1303.504; Tenn. Code Ann. Sec. 29-26-118; Tex. Rev.
                Civ. Stat. Ann. art. 4590i, Sec. 6.02; Utah Code Ann. Sec. 78-14-
                5; Vt. Stat. Ann. tit. 12, Sec. 1909; Wash. Rev. Code Ann. Sec.
                7.70.050; Wis. Stat. Ann. Sec. 448.30.
                 \101\ 42 CFR 482.51(b)(2).
                 \102\ 42 CFR 482.24(c)(4)(B)(v).
                 \103\ 45 CFR 46.116-117 (HHS Office of Human Research Subject
                regulations).
                ---------------------------------------------------------------------------
                 The Department knows of no data showing that the proper enforcement
                of Federal nondiscrimination law according to statutory text will
                disproportionately burden individuals on the basis of sexual
                orientation and/or gender identity. Because the 2016 Rule explicitly
                declined to make sexual orientation a protected category, and because
                the Rule's gender identity provision has been legally inoperative since
                December 31, 2016, to the extent that LGBT individuals suffer future
                harms, it cannot be attributed to the Department's finalizing this
                rule, as opposed to other causes.
                 Comment: Commenters raised concerns that, without the 2016 Rule's
                provisions, certain insurers, such as those offering short-term limited
                duration insurance plans, would not offer coverage for conditions that
                affect only women, such as uterine cancer. Some commenters stated that
                the underlying Title IX regulatory provisions are insufficient by
                themselves to address access to insurance coverage of procedures
                provided to a single sex in healthcare. Some commenters stated that,
                without the 2016 Rule, women would not be able to afford insurance for
                medical and hospital care.
                 Response: The Department is strongly committed to promoting women's
                health. The Department enforces or implements ACA provisions that
                protect patient access to obstetrical and gynecological care.\104\ The
                Department also enforces other provisions, both within and outside the
                ACA, that, for example, provide for maternity and newborn care as
                essential health benefits,\105\ require coverage of women's preventive
                health services,\106\ establish (as a matter of statute) the HHS Office
                of Women's Health and the Pregnancy Assistance Fund,\107\ and promote
                young women's breast health awareness.\108\
                ---------------------------------------------------------------------------
                 \104\ See, e.g., 42 U.S.C. 300gg-19a(d).
                 \105\ 42 U.S.C. 18022(b)(1)(D).
                 \106\ 42 U.S.C. 300gg-13.
                 \107\ 42 U.S.C. 237a; 42 U.S.C. 18202.
                 \108\ 42 U.S.C. 280m.
                ---------------------------------------------------------------------------
                 The Department's commitment to women's health also includes
                vigorous enforcement of Section 1557's prohibition on sex-based
                discrimination. Under HHS's Title IX regulations, which OCR will use
                for enforcing Section 1557, covered entities must provide medical
                insurance benefits, services, policies, and plans without
                discrimination on the basis of sex. This does not preclude a covered
                entity's providing a covered benefit or service that is used uniquely
                by individuals of one sex or the other, such as uterine cancer
                treatments. However, any plan that includes full-coverage health
                insurance or services must encompass gynecological care.\109\ As
                discussed in the relevant section below, the Department is bound by
                applicable law in determining the extent to which Section 1557 covers
                short-term limited duration insurance.
                ---------------------------------------------------------------------------
                 \109\ See, e.g., 45 CFR 86.39.
                ---------------------------------------------------------------------------
                 Comment: Some commenters said that the Department was wrong to
                claim in the 2019 NPRM that State and local entities are better
                equipped to address issues of gender dysphoria or sexual orientation,
                because they say that fifty percent of the LGBT population lives in
                States without laws prohibiting insurance companies from discriminating
                based on LGBT status. Others said that, because States like New York
                explicitly protect persons who identify as LGBT, the new rule will
                cause confusion for providers and patients about people's rights under
                Federal and State law. Some commenters suggested that including gender
                identity and sexual orientation in the Final Rule would reduce
                ambiguity in its interpretation and implementation.
                 Response: States and localities do indeed manifest a range of
                different views on what specific protections should be accorded to the
                categories of sexual orientation and gender identity in civil rights
                law, including healthcare civil rights law. That is precisely why,
                under our Constitutional Federal system, it is appropriate not to
                preempt States' diverse views on these topics without a clear mandate
                from Congress to do so. This final rule complies with the federalism-
                related portions of Executive Orders 12866 and 13132 by avoiding undue
                interference with State, local, or tribal governments in the exercise
                of their governmental functions. It leaves them free to balance the
                multiple competing considerations involved in the contentious and
                fraught set of questions surrounding gender dysphoria and gender
                identity, and to adopt protections on the basis of sexual orientation
                or gender identity to the extent that they see fit (so long as they
                comply with Federal law).\110\
                ---------------------------------------------------------------------------
                 \110\ Ambiguity in the 2016 Rule's provisions regarding gender
                identity is addressed below. The Department further notes that
                sexual orientation was explicitly rejected as a protected category
                under the 2016 Rule. 81 FR 31390 (``OCR has decided not to resolve
                in this rule whether discrimination on the basis of an individual's
                sexual orientation status alone is a form of sex discrimination.'').
                ---------------------------------------------------------------------------
                 The Department notes, furthermore, that under the guaranteed
                issuance and renewal provisions of the ACA, health insurance issuers
                that offer health insurance coverage in the individual or group market
                in a state must accept every employer and every individual in that
                state that applies for such coverage, and must renew or continue in
                force such coverage at the option of the plan sponsor or the
                individual. See 42 U.S.C. 300gg-1 (guaranteed issuance), 300gg-2
                (guaranteed renewability). Federal law similarly limits the bases on
                which a health insurance issuer can vary premium rates in the
                individual or small group market; such bases are limited to type of
                coverage (individual or family), rating area, age, and tobacco use. 42
                U.S.C. 300gg. Thus, commenters' concern that LGBT individuals could be
                denied coverage if the Section 1557 rule does not include gender
                identity (or sexual orientation) is misplaced.
                 Comment: One commenter expressed concern that the proposed rule
                will have an effect beyond the United States by showing the
                international community that the United States Federal government does
                not recognize protections for individuals based on gender identity or
                sexual orientation in healthcare.
                 Response: The Department is not primarily responsible for the
                United States' foreign relations. Moreover, the Department has an
                obligation to implement the statutes according to the plain language of
                the text passed by Congress (unless unconstitutional), regardless of
                international implications.
                 Comment: Some commenters requested that the Department retain all
                guidance it had issued under the 2016 Rule. Other commenters stated
                that components of HHS continue to offer
                [[Page 37183]]
                inconsistent guidance about the legal interpretation of the 2016 Rule.
                 Response: The Department stated in the preamble to the proposed
                rule that guidance under the 2016 Rule that conflicted with the
                proposed rule was suspended until further notice.\111\ All such
                guidance is hereby withdrawn, effective upon publication of this final
                rule, and is in the process of being removed from the Department's
                website. Pursuant to Executive Order 13891, the Administration is also
                undertaking efforts to comprehensively review guidance documents ``to
                ensure that Americans are subject to only those binding rules imposed
                through duly enacted statutes or through regulations lawfully
                promulgated under them, and that Americans have fair notice of their
                obligations,'' \112\ which also requires removal of inconsistent
                guidance from departmental websites.
                ---------------------------------------------------------------------------
                 \111\ 84 FR 27872 (``Upon publication of this notice of proposed
                rulemaking, the Department will, as a matter of enforcement
                discretion, suspend all subregulatory guidance issued before this
                proposed rule that interprets or implements Section 1557 (including
                FAQs, letters, and the preamble to [the 2016 Rule]) that is
                inconsistent with any provision in this proposed rule (including the
                preamble) or with the requirements of the underlying civil rights
                statutes cross-referenced by Section 1557 or their implementing
                regulations.'').
                 \112\ ``Promoting the Rule of Law Through Improved Agency
                Guidance Documents,'' Exec. Order No. 13891, 84 FR 55235 (Oct. 9,
                2019).
                ---------------------------------------------------------------------------
                ii. Gender Identity, Including Single-Sex Services Under Sec. 92.206
                of the 2016 Rule
                 The Department proposed to repeal the 2016 Rule's definition of
                ``on the basis of sex'' to encompass gender identity, which the 2016
                Rule defined as ``an individual's internal sense of gender, which may
                be male, female, neither, or a combination of male and female, and
                which may be different from an individual's sex assigned at birth.''
                \113\ The Department also proposed to repeal Sec. 92.206 of the 2016
                Rule, which has three elements. First, the section required covered
                entities not to discriminate ``on the basis of sex'' (as defined in
                Sec. 92.4 of the 2016 Rule) in providing access to health programs and
                activities. Second, it required them to ``treat individuals consistent
                with their gender identity.'' Third, it prohibited covered entities
                from ``deny[ing] or limit[ing] health services that are ordinarily or
                exclusively available to individuals of one sex, to a transgender
                individual based on the fact that the individual's sex assigned at
                birth, gender identity, or gender otherwise recorded is different from
                the one to which such health services are ordinarily or exclusively
                available.'' \114\
                ---------------------------------------------------------------------------
                 \113\ 81 FR 31387-88, 31467.
                 \114\ 81 FR 31471.
                ---------------------------------------------------------------------------
                 Comment: Commenters offered varying views on the state of gender-
                identity nondiscrimination protections under current Federal law. Some
                commenters alleged that it is settled law that Section 1557 prohibits
                gender identity discrimination. Others stated that, in other Federal
                court decisions on Title VII and Title IX, the text of the Title IX
                statute and regulation are held to be ``at least susceptible to'' the
                interpretation that it prohibits anti-transgender bias.\115\
                ---------------------------------------------------------------------------
                 \115\ See G.G. ex rel. Grimm v. Gloucester Cty. Sch. Bd., 822
                F.3d 709 (4th Cir. 2016), recalling mandate & issuing stay, 136 S.
                Ct. 2442 (2016).
                ---------------------------------------------------------------------------
                 Other commenters disagreed, stating that the courts are not
                unanimous on the question and pointed to legal precedent saying that
                gender identity is not encompassed by sex discrimination under Federal
                civil rights statutes. Commenters stated that the 2016 Rule had
                departed from existing civil rights law by creating new prohibited
                conduct unsupported by the text of the statutes. Commenters stated that
                Title IX has been interpreted by the courts for decades to apply to
                biological women.\116\ Other commenters stated that the fact that the
                Supreme Court has agreed to consider the legality of the general theory
                proposed in the 2016 Rule demonstrates it is a novel and contested
                legal issue.\117\ Other commenters stated Congress clearly intended
                ``sex discrimination'' to be defined with reference to biological
                classification as male or female, and that is the only understanding
                that is reasonably supported by the text, history, or structure of the
                relevant law. Some criticized the 2016 Rule's reliance on the EEOC's
                opinion in Macy v. Holder, 2012 EEOPUB LEXIS 1181, 112 FEOR (LRP) 257
                (2012) (Title VII).
                ---------------------------------------------------------------------------
                 \116\ See, e.g., N. Haven Bd. of Ed. v. Bell, 456 U.S. 512, 517-
                20, (1982); Cannon v. Univ. of Chi., 441 U.S. 677, 680 (1979).
                 \117\ Order, R.G. & G.R. Harris Funeral Homes v. EEOC, No. 18-
                107 (U.S. Apr. 22, 2019) (granting certiorari).
                ---------------------------------------------------------------------------
                 Response: The Department disagrees with commenters who contend that
                Section 1557 or Title IX encompass gender identity discrimination
                within their prohibition on sex discrimination. Some of the cases
                referenced by such commenters were decided under the Equal Protection
                Clause of the Constitution,\118\ under which courts have applied
                intermediate levels of scrutiny, permitting governments to adopt
                ``discriminatory means'' on the basis of sex only insofar as those
                means are substantially related to the achievement of important
                governmental objectives and are not ``used to create or perpetuate the
                legal, social, and economic inferiority of women.'' \119\ The
                Department does not agree that the Equal Protection cases cited by
                these commenters require Title IX to include a prohibition on gender
                identity discrimination. Unlike the Equal Protection Clause, Title VII
                and Title IX broadly forbid covered entities from discriminating on the
                basis of sex, with limited exemptions expressly provided in statute.
                Title VII exempts covered entities from the prohibition on sex
                discrimination where sex is a ``bona fide occupational qualification.''
                \120\ Title IX exempts covered entities from the prohibition on sex
                discrimination for admissions to historically single-sex colleges,
                school father-son and mother-daughter activities (so long as reasonably
                comparable activities are provided for students of both sexes), beauty
                pageants, certain boys' or girls' conferences, single-sex voluntary
                youth service organizations, fraternities and sororities, and military
                training programs.\121\
                ---------------------------------------------------------------------------
                 \118\ See Glenn v. Brumby, 663 F.3d 1312 (11th Cir. 2011).
                 \119\ United States v. Virginia, 518 U.S. 515, 516 (1996).
                 \120\ 42 U.S.C. 2000e-2(e)(1).
                 \121\ 20 U.S.C. 1681.
                ---------------------------------------------------------------------------
                 The text of Title IX also demonstrates that it is not susceptible
                to an interpretation under which it would prohibit gender identity
                discrimination. The statute permits covered entities to maintain
                ``separate living facilities for the different sexes,'' and it
                expressly presents this, not as an exemption from the nondiscrimination
                requirements, but as an ``interpretation'' of them: Separate-sex living
                facilities are not, as such, discriminatory.\122\ The Department's
                Title IX regulations likewise permit separate-sex housing, intimate
                facilities, physical education and human sexuality courses, and contact
                sports.\123\ The statute presents these distinctions as being fully
                compatible with its nondiscrimination requirement. Nondiscrimination
                requires that separate-sex facilities and programs be (where relevant)
                comparable to one another, but the existence of separate-sex facilities
                and programs is not, as such, discriminatory under Title IX.
                Consequently, the Department does not believe an interpretation of
                Title IX that would prohibit gender identity discrimination is
                compatible with the statute's overall approach towards what
                [[Page 37184]]
                does and does not constitute sex discrimination.
                ---------------------------------------------------------------------------
                 \122\ 20 U.S.C. 1686.
                 \123\ 45 CFR 86.32-34, Sec. 86.41.
                ---------------------------------------------------------------------------
                 Case law under both Title VII and Title IX has likewise recognized
                that these statutes do not forbid reasonable and relevant distinctions
                between the sexes.\124\ As the United States Solicitor General recently
                put it, ``Many commonplace practices that distinguish between the sexes
                do not violate [Title VII] because they account for real physiological
                differences between the sexes without treating either sex less
                favorably.'' \125\ No express statutory carve-out is required in order
                for employers under Title VII to be permitted to impose a sex-specific
                dress code that burdens men and women equally, nor in order for
                educational institutions under Title IX to be permitted to require men
                and women to shower separately from each other. And as compared to the
                fields of employment and of education, the field of healthcare
                necessarily may contain many more ``commonplace practices that
                distinguish between the sexes . . . [by] account[ing] for real
                physiological differences between the sexes without treating either sex
                less favorably.'' As discussed in greater detail later in the
                subsection of this preamble on gender identity, reasonable distinctions
                between the sexes may be called for in numerous areas within the
                Department's expertise, including shared hospital rooms,\126\ sex-
                specific protections for patients' modesty,\127\ specialized medical
                practices related to gynecology,\128\ and medical treatments or
                recommendations relying on sex-based generalizations,\129\ and other
                research situations.\130\ The biological differences between men and
                women are not irrelevant to employment law and education, and they are
                in many ways even more relevant in the health setting.
                ---------------------------------------------------------------------------
                 \124\ See Wittmer v. Phillips 66 Co., 915 F.3d 328, 334 (5th
                Cir. 2019) (Ho, J., concurring); Jespersen v. Harrah's Operating
                Co., 444 F.3d 1104, 1109-10 (9th Cir. 2006) (en banc) (collecting
                cases).
                 \125\ Brief for EEOC, R.G. & G.R. Harris Funeral Homes v. EEOC,
                No. 18-107 (U.S. filed Aug. 16, 2019), at 36.
                 \126\ See Cypress v. Newport News General and Nonsectarian
                Hospital Association, 375 F.2d 648, 658 (4th Cir. 1967) (``Our
                holding is simply that race cannot be a factor in the admission,
                assignment, classification, or treatment of patients in an
                institution like this, which is state-supported and receives federal
                funds. Room assignments may be made with due regard to sex, age,
                type of illness, or other relevant factors, but racial distinctions
                are impermissible, since the law forbids the treatment of
                individuals differently or separately because of their race, color,
                or national origin.''); cf. similar statutory requirements at 10
                U.S.C. 4319 (Army), 10 U.S.C. 6931 (Navy), and 10 U.S.C. * 9319 (Air
                Force) (requiring separation of sleeping and latrine areas for
                ``male'' and ``female'' recruits); 10 U.S.C. 4320 (Army), 10 U.S.C.
                6932 (Navy), and 10 U.S.C. 9320 (Air Force) (limiting after-hours
                access by drill sergeants and training personnel to persons of the
                ``same sex as the recruits'').
                 \127\ See, e.g., OCR Voluntary Resolution Agreement with
                Michigan State University, https://cms-drupal-hhs-prod.cloud.hhs.gov/sites/default/files/vra-between-msu-and-ocr.pdf,
                at IV.D.1.d.iii, IV.D.1.d.v.
                 \128\ See, e.g., Women's Preventive Services Guidelines, Health
                Resources and Services Administration, Dec. 17, 2019 (HRSA) https://www.hrsa.gov/womens-guidelines-2019.
                 \129\ See the Department's Office of Women's Health, https://www.womenshealth.gov/.
                 \130\ See NIH Guidance, Consideration of Sex as a Biological
                Variable in NIH-funded Research (2017), https://orwh.od.nih.gov/sites/orwh/files/docs/NOT-OD-15-102_Guidance.pdf; NIH, Office of
                Research on Women's Health, ``Sex & Gender,'' https://orwh.od.nih.gov/.
                ---------------------------------------------------------------------------
                 In general, a covered entity is permitted to make distinctions on
                the basis of sex that are ``not marked by misconception and prejudice,
                nor . . . show disrespect for either class.'' \131\ In many cases,
                removing or weakening such reasonable sex-based distinctions could
                undermine the equality of the sexes by disproportionately harming
                women.\132\ As discussed further below, case law is still developing as
                to whether covered entities' refusal to draw these distinctions could
                in some cases violate personal privacy interests and so create a
                hostile environment under Title IX.\133\ ``[N]eutral terms can mask
                discrimination that is unlawful,'' while ``gender specific terms can
                mark a permissible distinction.'' \134\ Where the ``[p]hysical
                differences between men and women'' are relevant, sex-neutral policies
                will in some cases ``undoubtedly require alterations'' to make them
                sex-specific, in order ``to afford members of each sex privacy from the
                other sex in living arrangements.'' \135\
                ---------------------------------------------------------------------------
                 \131\ See Tuan Anh Nguyen v. INS, 533 U.S. 73.
                 \132\ See Brief for EEOC, Harris Funeral Homes, at 37-38 (citing
                cases).
                 \133\ See, e.g., Doe v. Luzerne Cty., 660 F.3d 169, 176-77 (3d
                Cir. 2011) (recognizing that an individual has ``a constitutionally
                protected privacy interest in his or her partially clothed body''
                and that this ``reasonable expectation of privacy'' exists
                ``particularly while in the presence of members of the opposite
                sex''); Brannum v. Overton Cty. Sch. Bd., 516 F.3d 489, 494 (6th
                Cir. 2008) (``the constitutional right to privacy . . . includes the
                right to shield one's body from exposure to viewing by the opposite
                sex''); Fortner v. Thomas, 983 F.2d 1024, 1030 (11th Cir. 1993)
                (``[M]ost people have a special sense of privacy in their genitals,
                and involuntary exposure of them in the presence of people of the
                other sex may be especially demeaning or humiliating.''). But see
                Parents for Privacy v. Barr, No. 18-35708, (9th Cir. Feb. 12, 2020)
                (no title IX or constitutional privacy violation for school policy
                allowing student to use bathroom and locker rooms consistent with
                their gender identity).
                 \134\ Tuan Anh Nguyen v. INS, 533 U.S. 64.
                 \135\ United States v. Virginia, 518 U.S. 515, 550 n.19 (1996)
                (emphasis added) (brackets and citation omitted).
                ---------------------------------------------------------------------------
                 Comment: Commenters stated that Price Waterhouse v. Hopkins, 490
                U.S. 228 (1989), and Oncale v. Sundowner Offshore Oil Services, Inc.,
                523 U.S. 75 (1998), fully support or even require the 2016 Rule's
                gender identity provisions or their equivalent. Commenters asked the
                Department to address specific court cases that they stated were
                contrary to the Department's view, such as Doe v. Boyertown Area Sch.
                Dist., 897 F.3d 518 (3d Cir. 2018), Whitaker v. Kenosha Unified Sch.
                Dist. No. 1 Bd. of Educ., 858 F.3d 1034 (7th Cir. 2017), and Glenn v.
                Brumby, 663 F.3d 1312 (11th Cir. 2011).
                 Response: For most of the history of Title IX case law, the
                ``commonplace practices that . . . account for real physiological
                differences between the sexes without treating either sex less
                favorably'' \136\ were uncontroversial and not considered
                discriminatory. In the past five years, two circuit courts have begun
                to question this long-standing precedent in proceedings arising from
                motions for preliminary injunctions, although no circuit court has yet
                done so in a final ruling.\137\
                ---------------------------------------------------------------------------
                 \136\ Brief for EEOC, Harris Funeral Homes, at 36.
                 \137\ Whitaker v. Kenosha Unified Sch. Dist., 858 F.3d 1034,
                1039 (7th Cir. 2017); Dodds v. United States Dep't of Educ., 845
                F.3d 217 (6th Cir. 2016). The ruling in a third related case, G.G.
                v. Gloucester Co. Sch. Bd., 822 F.3d 709 (4th Cir. 2016), was based
                on Auer deference to Department of Education subregulatory guidance
                and has since been vacated after that guidance was withdrawn.
                ---------------------------------------------------------------------------
                 These courts (and some district courts) draw on the Supreme Court's
                reasoning in Price Waterhouse in order to assert that otherwise
                permissible distinctions on the basis of sex must be applied (if at
                all) on the basis of an individual's subjective gender identity. But
                the novel legal theory advanced by these courts represents a serious
                misreading of Price Waterhouse and of Title IX, a reading that has been
                disputed by the decisions of other courts, including Franciscan
                Alliance.
                 Price Waterhouse is a Title VII case and establishes that, `` `[i]n
                forbidding employers to discriminate against individuals because of
                their sex, Congress intended to strike at the entire spectrum of
                disparate treatment of men and women resulting from sex stereotypes.'
                '' \138\
                ---------------------------------------------------------------------------
                 \138\ Price Waterhouse v. Hopkins, 490 U.S. 228, 251 (1989),
                quoting Los Angeles Dept. of Water & Power v. Manhart, 435 U. S.
                702, 707, n. 13 (1978).
                ---------------------------------------------------------------------------
                 When courts have read Price Waterhouse as determining that ``on the
                basis of sex'' encompasses gender identity, they have done so on the
                ground that discrimination on the basis of gender identity is, as such,
                a form of sex stereotyping. But Price Waterhouse should be read in
                light of the Supreme Court definition of a ``stereotype'' about sex
                ``as a frame of mind resulting from
                [[Page 37185]]
                irrational or uncritical analysis.'' \139\ Wherever ``stereotyping
                play[s] a motivating role in an employment decision,'' according to
                Price Waterhouse, the employer has demonstrated an ``impermissible
                motive,'' for stereotypes should not even ``play a part in the
                decisionmaking process.'' \140\
                ---------------------------------------------------------------------------
                 \139\ Tuan Anh Nguyen v. I.N.S., 533 U.S. 53, 68 (2001).
                 \140\ Price Waterhouse, 490 U.S. 252-53, 254-55. The Civil
                Rights Act of 1991 amends the Price Waterhouse standard to say that
                ``an unlawful employment practice is established when the
                complaining party demonstrates that . . . sex . . . was a motivating
                factor for any employment practice, even though other factors also
                motivated the practice,'' but the employer may rebut this claim if
                he or she ``demonstrates that [the employer] would have taken the
                same action in the absence of the impermissible motivating factor.''
                42 U.S.C. 2000e-2(m), Sec. 2000e-5(g)(2)(B).
                ---------------------------------------------------------------------------
                 The Department believes that, unlike stereotypes, reasonable
                distinctions on the basis of sex, as the biological binary of male and
                female, may, and often must, ``play a part in the decisionmaking
                process''--especially in the field of health services. A covered entity
                such as a healthcare provider is not impermissibly stereotyping
                biological males (notwithstanding their internal sense of gender) on
                the basis of sex if it uses pronouns such as ``him''; limits access to
                lactation rooms and gynecological practices to female users and
                patients; or lists a male's sex as ``male'' on medical forms.
                Similarly, a covered health care entity is not impermissibly
                stereotyping biological females (notwithstanding their internal sense
                of gender) on the basis of sex if it uses pronouns such as ``her'';
                warns females that heart-attack symptoms are likely to be quite
                different than those a man may experience; advises women that certain
                medications tend to affect women differently than men; or lists a
                female's sex as ``female'' on medical forms. Finally, it is not
                stereotyping for covered entities to have bathrooms or changing rooms
                designated by reference to sex, or to group patients in shared hospital
                rooms by sex.\141\ Such practices and actions are not rooted in
                stereotypes, but in real biological or physiological differences
                between the sexes. Moreover, none of these examples disadvantages one
                sex over another, and in fact the failure to take sex into account may
                in some cases have a disadvantageous effect.
                ---------------------------------------------------------------------------
                 \141\ See 29 CFR 1910.141(c) (OSHA regulation requiring ``toilet
                rooms separate for each sex'').
                ---------------------------------------------------------------------------
                 As the Supreme Court has noted, ``to fail to acknowledge even our
                most basic biological differences . . . risks making the guarantee of
                equal protection superficial, and so disserving it. Mechanistic
                classification of all our differences as stereotypes would operate to
                obscure those misconceptions and prejudices that are real.'' \142\
                ``[T]here is nothing irrational or improper in the recognition'' of the
                social and other consequences of real physiological differences between
                the sexes; ``[t]his is not a stereotype.'' \143\ Reasonable
                distinctions ``may be based on real differences between the sexes . . .
                so long as the distinctions are not based on stereotyped or generalized
                perceptions of differences.'' \144\ ``Prohibition of harassment on the
                basis of sex requires neither asexuality nor androgyny.'' \145\
                ---------------------------------------------------------------------------
                 \142\ Tuan Anh Nguyen, 533 U.S. at 73. In Sessions v. Morales-
                Santana, 137 S. Ct. 1678 (2017), the Supreme Court struck down, on
                intermediate-scrutiny grounds, a statute that granted U.S.
                citizenship to children born abroad of unwed parents if the child's
                mother had been a U.S. citizen for one year before the birth, but
                required five years in the case of a U.S. citizen father. However,
                the Court did not reject the Nguyen analysis recognizing that sex
                distinctions are real, and that not all such distinctions are based
                on unlawful stereotypes.
                 \143\ Id. at 68.
                 \144\ Faulkner v. Jones, 10 F.3d 226, 232 (4th Cir. 1993).
                 \145\ Oncale v. Sundowner Offshore Oil Services, Inc., 523 U.S.
                75, 81 (1998).
                ---------------------------------------------------------------------------
                 Justice Ginsburg's majority opinion in U.S. v. Virginia sharply
                distinguished sex from other protected classes in this regard:
                ``Supposed `inherent differences' are no longer accepted as a ground
                for race or national origin classifications. Physical differences
                between men and women, however, are enduring: `[T]he two sexes are not
                fungible; a community made up exclusively of one [sex] is different
                from a community composed of both.' . . . `Inherent differences'
                between men and women, we have come to appreciate, remain cause for
                celebration.'' \146\ This recognition of physical (i.e., biological)
                differences between men and women is not stereotyping and in some cases
                will ``undoubtedly require alterations'' to accommodated sex-specific
                differences.\147\
                ---------------------------------------------------------------------------
                 \146\ United States v. Virginia, 518 U.S. 515, 533 (1996)
                (internal citations omitted).
                 \147\ Id. at 550 n.19.
                ---------------------------------------------------------------------------
                 The lower court decisions referenced by commenters held that a
                covered entity which required transgender individuals to abide by
                otherwise permissible distinctions on the basis of sex, such as
                separate-sex bathrooms, would be impermissibly ``imposing its
                stereotypical notions of how sexual organs and gender identity ought to
                align.'' \148\ A few lower courts have relied on these holdings in
                interpreting Section 1557 to require covered entities to override these
                reasonable distinctions based on sex, in deference to an individual's
                gender identity.\149\ The notion that such distinctions on the basis of
                sex amount, as such, to impermissible stereotyping, would be lethal to
                countless reasonable and fully permissible healthcare practices, some
                of which have been identified above. No court has gone so far: These
                lower courts have questioned such distinctions only insofar as these
                distinctions come into conflict with an individual's stated gender
                identity. But Price Waterhouse offers no basis for this regime of
                individualized exceptions to otherwise reasonable distinctions. If it
                is impermissible stereotyping of a female employee to demand that she
                not ``behave aggressively,'' then Price Waterhouse (to the extent that
                it applies) requires companies to stop holding all female employees to
                such a stereotyped standard--not merely to grant exceptions for the
                occasional female employee who objects to that standard.\150\
                Similarly, if it is impermissible stereotyping to assume that ``sexual
                organs . . . ought to align'' with the sex listed on one's hospital
                bracelet, then Price Waterhouse (to the extent that it applies) would
                invalidate the existence of all sex markers on hospital bracelets, not
                merely of those to which a transgender individual has objected. Where a
                covered entity has not stereotyped but has only drawn a reasonable
                distinction, Price Waterhouse is irrelevant.
                ---------------------------------------------------------------------------
                 \148\ Equal Employment Opportunity Comm'n v. R.G. &. G.R. Harris
                Funeral Homes, Inc., 884 F.3d 560, 576 (6th Cir. 2018). See also
                Whitaker v. Kenosha Unified Sch. Dist., 858 F.3d 1034, 1051 (7th
                Cir. 2017) (``the School District treats transgender students like
                Ash, who fail to conform to the sex[hyphen]based stereotypes
                associated with their assigned sex at birth, differently. These
                students are disciplined under the School District's bathroom policy
                if they choose to use a bathroom that conforms to their gender
                identity.''); Glenn v. Brumby, 663 F.3d 1312, 1316 (11th Cir. 2011)
                (``A person is defined as transgender precisely because of the
                perception that his or her behavior transgresses gender
                stereotypes.'').
                 \149\ See Rumble v. Fairview Health Servs., No. 14-cv-037 (SRN/
                FLN), 2017 WL 401940 (D. Minn. Jan. 30, 2017); Prescott v. Rady
                Children's Hospital-San Diego, 265 F. Supp. 3d 1090, 1098-100 (S.D.
                Cal. 2017)
                 \150\ See Price Waterhouse, 490 U.S. at 235, 250-51.
                ---------------------------------------------------------------------------
                 Distinctions based on real differences between men and women do not
                turn into discrimination merely because an individual objects to those
                distinctions. Title IX does not require covered entities to eliminate
                reasonable distinctions on the basis of sex whenever an individual
                identifies with the other sex, or with no sex at all, or with some
                combination of the two sexes
                [[Page 37186]]
                (as under the 2016 Rule).\151\ Rather, Title IX prohibits subjecting a
                person to less favorable treatment because of his or her sex. Thus, if
                a person claims to have been discriminated against on the basis of his
                or her sex, that claim is neither weakened nor strengthened by any
                allegations about his or her ``internal sense of gender.'' Numerous
                lower courts have held that, like any other man or woman, a transgender
                individual may sue under Title VII if he or she is harassed, assaulted,
                terminated, or otherwise discriminated against because of his or her
                sex.\152\ Under Title IX, as under Title VII, ``[t]ranssexuals are not
                genderless, they are either male or female and are thus protected under
                Title VII to the extent that they are discriminated against on the
                basis of sex.'' \153\ The Department will vigorously enforce Section
                1557's prohibition on sex-based discrimination, but that prohibition
                cannot be construed as a prohibition on reasonable sex-based
                distinctions in the health field.
                ---------------------------------------------------------------------------
                 \151\ See Johnston v. Univ. of Pittsburgh of the Commonwealth
                Sys. of Higher Educ., 97 F. Supp. 3d 657 (W.D. Pa. 2015).
                 \152\ Barnes v. City of Cincinnati, 401 F.3d 729 (6th Cir.
                2005); Smith v. City of Salem, 378 F.3d 566 (6th Cir. 2004). These
                cases have been cited, by the 2016 Rule and in some recent court
                cases, in support of the view that sex discrimination encompasses
                discrimination on the basis of gender identity. This is a serious
                misreading pointed out at Johnston v. Univ. of Pittsburgh of Com.
                Sys. of Higher Educ., 97 F. Supp. 3d 657, 675n17 (W.D. Pa. 2015)
                (``In Smith v. City of Salem, . . . the court did not conclude that
                ``transgender'' is a protected class under Title VII, but only that
                a male or female who is also transgender can assert a sex
                stereotyping claim under Title VII for adverse employment actions
                that result from the individual's conformity to their gender
                identity rather than their biological or birth sex. Indeed, the same
                year that the 6th Circuit issued its opinion in Smith, it affirmed,
                in an unpublished opinion, a district court decision holding that
                ``Title VII does not prohibit discrimination based on an
                individual's status as a transsexual,'' in an employment
                discrimination case involving a transgender women's use of a men's
                restroom. Johnson v. Fresh Mark, Inc., 98 Fed. App'x. 461, 462 (6th
                Cir.2004).'').
                 \153\ Tronetti v. TLC HealthNet Lakeshore Hosp., No. 03-CV-
                0375E(SC), 2003 WL 22757935, at *4 (W.D.N.Y. Sept. 26, 2003). See
                Rosa v. Park West Bank Trust Co., 214 F.3d 213, 215-16 (1st Cir.
                2000) (discrimination against a cross-dressing man is sex-based
                discrimination if the entity would have treated a ``similarly
                situated'' woman differently, i.e., if it treats ``a woman who
                dresses like a man differently than a man who dresses like a
                woman'').
                ---------------------------------------------------------------------------
                 Comment: Commenters offered a variety of views on the role that a
                patient's sex and/or gender identity ought to play in medical decision-
                making.
                 Many commenters spoke of the importance of sex-reassignment
                surgeries and cited studies that they said show the value of these
                surgeries in alleviating gender dysphoria. Others cited different
                studies that they said show the opposite. Some clinicians expressed
                concerns about consent and medical appropriateness of pre-pubertal sex
                reassignment with lifelong physical and mental implications (including
                permanent sterility) when children and adolescents lack the requisite
                social, emotional, and intellectual maturity, or life experiences
                necessary for true consent. Commenters also were concerned about
                coercive, peer, adult, and ideological pressures on children and
                adolescents to seek cross-sex hormonal treatment, sex reassignment
                surgery, or other similar services. Some commenters, including parties
                to lawsuits against the Department on the ground that the 2016 Rule
                would require gender transition treatments and therapies for children,
                criticized the 2016 Rule for containing no age limitation. Commenters
                stated that the ``gender-affirming'' model is the most controversial
                form of counseling and, as such, is not used by the Dutch national
                transgender clinic, which they said is considered the international
                flagship of gender dysphoria treatment.
                 Some commenters noted that violations of the 2016 Rule are
                enforceable by termination of Federal financial assistance and that
                violations of State law with respect to healthcare may involve civil
                penalties for negligence or malpractice, etc. In light of this, they
                stated that the 2016 Rule placed providers in an impossible position,
                where compliance with one law means noncompliance with another, and
                either choice results in a steep penalty.
                 Other commenters said that the 2016 Rule's definition of ``on the
                basis of sex'' could prohibit the way OB/GYN practices specialize in
                treating females, and raised the concern that specializing in the
                treatment of female patients could be deemed prohibited discrimination
                against biological males who identify as women. Commenters stated that
                because these services are focused on and tailored to females as a
                single biological sex, they are able to provide a higher quality of
                care to those patients. They noted that it has long been a permissible
                sex-based distinction for OB/GYN doctors to not treat any biological
                males, and this distinction is recognized under HHS Title IX
                regulations. Such commenters found the 2016 Rule overbroad and
                inconsistent with day-to-day affairs in how they practice medicine. But
                other commenters stated that OB/GYNs are not affected by the
                transgender requirements under the 2016 Rule and that pre-existing OB/
                GYN practices are justified by reasonable scientific justifications.
                 Certain providers advocated for removal of the requirement to
                ``treat individuals consistent with their gender identity,'' as this
                provision would violate the conscience rights of healthcare providers,
                and the ethical and foundational convictions that underlie the entire
                way they practice medicine. Other commenters said that repeal of this
                provision leaves no clarity about whether such providers will actually
                provide treatment for transgender patients, and expressed the concern
                that affirming treatment consistent with gender identity is necessary
                for high-value transgender healthcare, as is required for all people in
                the practice of medicine.
                 Some commenters noted their concern that the 2016 Rule requires
                doctors to remove healthy reproductive tissue in sex-reassignment
                surgeries, even if it may be contrary to the patient's medical
                interest. For example, if a surgeon performs mastectomies as part of a
                medically necessary treatment for breast cancer, under the 2016 Rule,
                he or she could also have been required to perform mastectomies for
                sex-reassignment purposes when recommended by a psychologist, even if
                the surgeon believes such treatments are not medically indicated in his
                or her own professional judgment. Similarly, commentators argued that
                some doctors might be forced to perform hysterectomies not only against
                their medical judgment but also outside of their expertise. Other
                commenters contended that certain procedures are not meaningfully
                different when performed on a transgender versus non-transgender
                patient, because the mechanics of the procedures are substantially
                similar. Although genital reassignment surgery is considered a ``gender
                transition service,'' clinicians commented that somewhat similar
                procedures are used for genital reconstruction to repair damaged,
                diseased, or disfigured genital tissue, or in the treatment of
                disorders of sexual development.
                 Commenters also stated that the 2016 Rule would force them to
                provide services damaging to the health of patients, in conflict with
                their mission as a healthcare provider, instead of using these medical
                resources to help patients.\154\
                ---------------------------------------------------------------------------
                 \154\ Commenters cited specific examples of coercion. See Minton
                v. Dignity Health, 2017 WL 7733922 (Cal. Super. Ct. Nov. 2017);
                Robinson v. Dignity Health, No. 16-cv-3035 YGR, 2016 WL 7102832
                (N.D. Cal. Dec. 6, 2016) (on remand from U.S. Supreme Court).
                ---------------------------------------------------------------------------
                 Commenters stated that HHS does not have a compelling interest in
                requiring the medical provision of, or insurance
                [[Page 37187]]
                for, gender transition services or procedures. Other commenters stated
                that access to such services for transgender patients constitutes a
                compelling interest. Some commenters challenged the idea that an
                individual born as one biological sex can in actuality be transformed
                into a person of the other sex, with or without surgeries or hormone
                treatments.
                 Response: The Department recognizes that certain single-sex medical
                procedures, treatments, or specializations are rooted in the binary and
                biological meaning of sex for valid scientific and medical reasons. The
                Department believes the 2016 Rule caused significant confusion and cast
                doubt as to whether such longstanding specialized practices remained
                lawful, as indicated, for example, by the fact that commenters had
                diverging views on how the 2016 Rule impacted OB/GYN practices. The
                Department declines to interfere in these practices, and repeals a
                mandate that was, at least, ambiguous and confusing.
                 The Department appreciates the many comments received on the issue
                of gender identity, gender dysphoria, and the appropriate care for
                individuals with gender dysphoria. The Department believes providers
                should be generally free to use their best medical judgment, consistent
                with their understanding of medical ethics, in providing healthcare to
                Americans. The wide variation in these comments confirms that the
                medical community is divided on many issues related to gender identity,
                including the value of various ``gender-affirming'' treatments for
                gender dysphoria (especially for minors), the relative importance of
                care based on the patient's sex, and the compatibility of gynecological
                practice with a requirement of nondiscrimination on the basis of gender
                identity.\155\
                ---------------------------------------------------------------------------
                 \155\ Comments referring specifically to providers'
                conscientious objections to certain forms of treatment are addressed
                below in the section on ``relation to other laws.''
                ---------------------------------------------------------------------------
                 The Department is also reluctant to pretermit ongoing medical
                debate and study about the medical necessity of gender transition
                treatments. The 2016 Rule assumed that, if a covered entity offers a
                ``categorical coverage exclusion or limitation for all health services
                related to gender transition,'' then that entity must be relying on
                medical judgments that are ``outdated and not based on current
                standards of care.'' \156\ But based on its review of the most recent
                evidence, the Department concludes that this was an erroneous
                assertion, and that there is, at a minimum, a lack of scientific and
                medical consensus to support this assertion, as the comments noted
                above demonstrate. This lack of scientific and medical consensus--and
                the lack of high-quality scientific evidence supporting such
                treatments--is borne out by other evidence. For example, on August 30,
                2016, CMS declined to issue a National Coverage Determination (NCD) on
                sex-reassignment surgery for Medicare beneficiaries with gender
                dysphoria ``because the clinical evidence is inconclusive.'' \157\ CMS
                determined, ``[b]ased on an extensive assessment of the clinical
                evidence,'' that ``there is not enough high quality evidence to
                determine whether gender reassignment surgery improves health outcomes
                for Medicare beneficiaries with gender dysphoria and whether patients
                most likely to benefit from these types of surgical intervention can be
                identified prospectively.'' \158\ Similarly, in a 2018 Department of
                Defense (DOD) report on the diagnosis of gender dysphoria, which
                included input from both transgender individuals and medical
                professionals with experience in the care and treatment of individuals
                with gender dysphoria, DOD found that there is ``considerable
                scientific uncertainty and overall lack of high quality scientific
                evidence demonstrating the extent to which transition-related
                treatments, such as cross-sex hormone therapy and sex reassignment
                surgery--interventions which are unique in psychiatry and medicine--
                remedy the multifaceted mental health problems associated with gender
                dysphoria.'' \159\ Other research has found that children who socially
                transition in childhood faced dramatically increased likelihood of
                persistence of gender dysphoria into adolescence and adulthood.\160\
                The Department does not believe that the nondiscrimination requirements
                in Title IX, incorporated by reference into Section 1557, foreclose
                medical study or debate on these issues. And to the extent that a
                medical consensus develops on these issues, it is not clear that
                regulations of the sort encompassed in the 2016 Rule would be necessary
                to encourage medical professionals to follow such consensus.
                ---------------------------------------------------------------------------
                 \156\ Cf. 81 FR 31472, 31429.
                 \157\ CMS, ``Decision Memo for Gender Dysphoria and Gender
                Reassignment Surgery'' (CAG-00446N) (Aug. 30, 2016) https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=282.
                 \158\ Id.
                 \159\ Department of Defense, ``Report and Recommendations on
                Military Service by Transgender Persons'' (Feb. 22, 2018), 5.
                 \160\ Thomas D. Steensma, Ph.D., Jenifer K. McGuire, Ph.D.
                M.P.H., et al. ``Factors Associated with Desistance and Persistence
                of Childhood Gender Dysphoria: A Quantitative Follow-Up Study,''
                52(6) Journal of the American Academy of Child & Adolescent
                Psychiatry 582-90 (2013).
                ---------------------------------------------------------------------------
                 The Department believes that its approach in the 2016 Rule
                inappropriately interfered with the ethical and medical judgment of
                health professionals. The preamble to the 2016 Rule stated that, under
                that Rule, ``a provider specializing in gynecological services that
                previously declined to provide a medically necessary hysterectomy for a
                transgender man would have to revise its policy to provide the
                procedure for transgender individuals in the same manner it provides
                the procedure for other individuals.'' \161\ This statement raised the
                prospect of forcing a provider to perform irreversible, sterilizing,
                and endocrine-disrupting procedures on what may be, in the provider's
                view, non-diseased and properly functioning organs--including in
                children and youth.\162\ A medical provider may rightly judge a
                hysterectomy due to the presence of malignant tumors to be different in
                kind from the removal of properly functioning and healthy reproductive
                tissue for psychological reasons, even if the instruments used are
                identical. For example, OB/GYNs competent and willing to perform
                dilation and curettage procedures to aid with recovery from a
                miscarriage should not, and legally cannot,\163\ be forced to perform
                dilation and curettage procedures for abortions, because the
                regulatory, ethical, and medical frameworks that apply to abortions are
                radically different from those that apply to recovery from
                miscarriages. Moreover, commenters who offer transition services made
                clear that these often involve specialized cross-sex hormonal
                treatments before and after any sex-reassignment surgeries, and require
                coordination of care with urologists, psychiatrists, and a variety of
                other healthcare professionals in different specialized fields. A
                provider who routinely provides, for example, hysterectomies to address
                uterine cancer should be able reasonably to choose not to be involved
                in what may be the much more medically complicated set of procedures
                involved in sex reassignment.
                ---------------------------------------------------------------------------
                 \161\ 81 FR 31455.
                 \162\ In this regard, the Department distinguishes between the
                situation created by the requirements of 2016 Rule and the in-
                program requirements applied within federally funded grant programs
                where, for example, ``the general rule that the Government may
                choose not to subsidize speech applies with full force,'' even if
                the speech concerns what is allegedly required by medical ethics.
                See, e.g., Rust v. Sullivan, 500 U.S. 173, 200 (1991).
                 \163\ See Church Amendments, 42 U.S.C. 300a-7.
                ---------------------------------------------------------------------------
                [[Page 37188]]
                 Upon reconsidering this issue, the Department now believes that the
                2016 Rule did not offer a sufficient analysis to justify the serious
                effect of requiring providers to perform certain procedures or provide
                certain treatments contrary to their medical judgment. The Department
                does not and need not take a definitive view on any of the medical
                questions raised in these comments about treatments for gender
                dysphoria. The question is whether Title IX and Section 1557 require
                healthcare professionals, as a matter of nondiscrimination, to perform
                such procedures or provide such treatments. The answer is that they do
                not. This final rule does not presume to dictate to medical providers
                the degree to which sex matters in medical decision making, nor does it
                impose the 2016 Rule's vague and overbroad mandate that they ``treat
                individuals consistent with their gender identity.''
                 Nothing in this final rule prohibits a healthcare provider from
                offering or performing sex-reassignment treatments and surgeries, or an
                insurer from covering such treatments and procedures, either as a
                general matter or on a case-by-case basis. The large number of comments
                received from healthcare providers who perform such treatments and
                procedures suggests that there is no shortage of providers willing to
                do so, even without the 2016 Rule's provisions on gender identity
                (which had been enjoined for over two years by the time of the comment
                period).
                 Finally, the Franciscan Alliance court held that HHS had not
                demonstrated a compelling interest in requiring providers with
                sincerely held religious objections to gender transition services,
                notwithstanding their objections, to provide these services. The
                Department sees no compelling interest in forcing the provision, or
                coverage, of these medically controversial services by covered
                entities, much less in doing so without a statutory basis.
                 Comment: Some commenters stated that revising the rule to eliminate
                the court-vacated provisions on gender identity, in conjunction with
                other Federal actions related to gender transition-related services, is
                evidence of animus to transgender individuals, and that the free
                exercise of religion or conscience claims raised by medical
                professionals and insurers are merely ``pretext'' for invidious
                discrimination. Others contended that the proposed rule recognizes the
                human dignity of all because certain surgical procedures and
                medications related to gender identity and abortion do not actually
                serve the health or wellbeing of patients but violate their dignity and
                physical and psychological integrity, especially of children and women
                in crisis pregnancies, and that these providers act out of sincere
                beliefs both as to medical judgment and religious belief in pursuing
                the best interests of patients regardless of their background or stated
                identities.
                 Response: The Department respects the dignity of all individuals.
                It seeks to further the health and well-being of all, but it can do so
                only by implementing the laws as adopted by Congress.
                 Moreover, the Department notes that commenters have provided a
                number of bases for objections to being forced to provide or cover
                certain treatments or surgeries contrary to their sincere medical,
                economic, religious, scientific, ethical, or conscience-based reasons.
                To presume that religious beliefs on these issues are rooted in
                bigotry, animosity, or insincerity would risk unlawfully stereotyping
                people of faith. See Masterpiece Cakeshop v. Colorado Civil Rights
                Comm'n, 138 S. Ct. 1719, 1729 (2018) (``To describe a man's faith as
                `one of the most despicable pieces of rhetoric that people can use' is
                to disparage his religion in at least two distinct ways: By describing
                it as despicable, and also by characterizing it as merely rhetorical--
                something insubstantial and even insincere.'').\164\
                ---------------------------------------------------------------------------
                 \164\ Religious exemptions will be addressed further in the
                section discussing the final rule's relation to other laws.
                ---------------------------------------------------------------------------
                 Comment: Commenters expressed various views on whether transgender
                patients should be treated in accord with their expressed gender
                identity and/or in accord with their sex.
                 Some commenters stated that transgender designations conceal real
                biological sex differences that are relevant to medical risk factors,
                recognition of which is important for effective diagnosis, treatment,
                and disease prevention--including effective treatment for patients who
                identify as transgender. Some added that biological sex differences
                remain present in numerous bodily systems even after a patient has
                undergone hormonal and/or surgical transition therapies, and that
                physicians must be permitted to take these differences into account.
                Healthcare providers commented that critical decisions are made in the
                practice of medicine on the basis of objective biological information
                concerning a person's sex as being male or female because, among other
                reasons, medications and treatments affect males and females
                differently, and only females can become pregnant, regardless of stated
                gender identity. These commenters were concerned that by requiring
                providers to treat patients consistent with gender identity instead of
                biological sex, the patients' health is endangered, with both short-
                and long-term consequences.\165\
                ---------------------------------------------------------------------------
                 \165\ Commenters cited texts including William J. Malone, MD,
                Gender Dysphoria Resource for Providers (3rd Edition); and Michael
                Laidlaw, MD, ``The Gender Identity Phantom,'' International
                Discussion Space for Clinicians and Researchers (Oct. 24, 2018)
                http://gdworkinggroup.org/2018/10/24/the-gender-identity-phantom.
                ---------------------------------------------------------------------------
                 Other commenters stated that the Department has not provided
                sufficient explanation or justification for removing Sec. 92.206 of
                the 2016 Rule with respect to ensuring equal access to healthcare
                services without respect to sex, including prohibitions on
                discriminatory denials of services typically associated with one sex to
                persons who identify as transgender. The commenters stated that the
                Department ignored the text of Sec. 92.206 when it asserted in the
                proposed rule that the 2016 Rule would ``require[e] healthcare entities
                to code as male all persons who self-identify as male, regardless of
                biology, [which] may lead to adverse health consequences.'' \166\
                Commenters said Sec. 92.206 properly prohibits, among other things,
                the arbitrary denial of care based not on clinical considerations but
                solely on the patient's ``sex as assigned at birth'' or as recorded in
                medical or insurance records. Others said that while the biological
                definition of ``sex'' may be appropriate for scientific contexts such
                as National Institutes of Health (``NIH'') studies, the Department's
                nondiscrimination provisions should define the term more broadly.
                ---------------------------------------------------------------------------
                 \166\ See 84 FR 27885, n. 55.
                ---------------------------------------------------------------------------
                 Some commenters commented on a case of a transgender patient with
                abdominal pains who, as a result of being treated according to a male
                gender identity, was not diagnosed as being pregnant as part of the
                triage process and had a stillborn child. Some commenters viewed this
                set of facts as evidence against the 2016 Rule while others claimed it
                was evidence for the 2016 Rule.
                 Response: The Department has long recognized that the practice of
                medicine and biomedical research routinely involves decisions and
                diagnoses that legitimately make distinctions based on sex, including
                decisions made at triage; research studies (including clinical trials);
                questions of medical history; and requests for a medical consultation.
                As discussed at length in the NPRM, substantial scientific literature
                published after the 2016 Rule indicates that sex-specific practices in
                medicine and research exist because biological
                [[Page 37189]]
                (and, derivatively, genetic) differences between males and females are
                real and matter to health outcomes and research.\167\ For example, NIH
                requires research grant applicants to consider sex as a biological
                variable ``defined by characteristics encoded in DNA, such as
                reproductive organs and other physiological and functional
                characteristics.'' \168\ According to an NIH article,
                ---------------------------------------------------------------------------
                 \167\ See, e.g., NIH Research Matters, Gene Linked to Sex
                Differences in Autism (Apr. 14, 2020), https://www.nih.gov/news-events/nih-research-matters/gene-linked-sex-differences-autism; Wei
                Yang, Nicole M. Warrington, et al., Clinically Important Sex
                differences in GBM biology revealed by analysis of male and female
                imaging, transcriptome and survival data, Science Translational
                Medicine (Jan. 21, 2019), https://www.ncbi.nlm.nih.gov/pubmed/30602536S (identifying sex-specific molecular subtypes of
                glioblastoma); Ramona Stone and W. Brent Weber, Male-Female
                Differences in the Prevalence of Non-Hodgkin Lymphoma, 81 Journal of
                Environmental Health 16 (Oct. 2018); https://www.ncbi.nlm.nih.gov/pubmed/28065609; Anke Samulowitz, Ida Gremyr, et al., ``Brave Men''
                and ``Emotional Women'': A Theory-Guided Literature Review on Gender
                Bias in Health Care and Gendered Norms towards Patients with Chronic
                Pain, Pain Research and Management (Feb. 25, 2018), https://www.ncbi.nlm.nih.gov/pubmed/29682130 (stating that ``the response to
                opioid receptor antagonists may generate a difference between men's
                and women's experiences of pain''); Douglas C. Dean III, E.M.
                Planalp, et al., Investigation of brain structure in the 1-month
                infant, Brain Structure and Function 1-18 (Jan. 5, 2018), https://www.ncbi.nlm.nih.gov/pubmed/29305647 (finding differences between
                male and female infants at the age of 1 month); Stefan Ballestri,
                Fabio Nascimbeni, et al., NAFLD as a Sexual Dimorphic Disease: Role
                of Gender and Reproductive Status in the Development and Progression
                of Nonalcoholic Fatty Liver Disease and Inherent Cardiovascular
                Risk, Advances in Therapy (May 19, 2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5487879; Susan Sullivan, Anna
                Campbell, et al., What's good for the goose is not good for the
                gander: Age and gender differences in scanning emotion faces, 72:3
                Journals of Gerontology 441 (May 1, 2017), https://www.ncbi.nlm.nih.gov/pubmed/25969472; Ester Serrano-Saiz, Meital
                Oren-Suissa, et al., Sexually Dimorphic Differentiation of a C.
                Elegans Hub Neuron Is Cell Autonomously Controlled by a Conserved
                Transcription Factor, 27 Current Biology 199 (Jan. 5, 2017).
                 \168\ NIH Guidance, Consideration of Sex as a Biological
                Variable in NIH-funded Research at 1 (2017), https://orwh.od.nih.gov/sites/orwh/files/docs/NOT-OD-15-102_Guidance.pdf.
                [s]ex as a biological variable (SABV) is a key part of the new
                National Institutes of Health (NIH) initiative to enhance
                reproducibility through rigor and transparency. The SABV policy
                requires researchers to factor sex into the design, analysis, and
                reporting of vertebrate animal and human studies. The policy was
                implemented as it has become increasingly clear that male/female
                differences extend well beyond reproductive and hormonal issues.
                Implementation of the policy is also meant to address inattention to
                sex influences in biomedical research. Sex affects: Cell physiology,
                metabolism, and many other biological functions; symptoms and
                manifestations of disease; and responses to treatment. For example,
                sex has profound influences in neuroscience, from circuitry to
                physiology to pain perception.\169\
                ---------------------------------------------------------------------------
                 \169\ Janine Austin Clayton (Office of Research on Women's
                Health, NIH), ``Applying the new SABV (sex as a biological variable)
                policy to research and clinical care.'' Physiology & Behavior 187
                (2018), 2.
                Yet the 2016 Rule required covered entities to ``treat individuals
                consistent with their gender identity'' in virtually every respect. The
                2016 Rule's definition of gender identity does not turn on any
                biological or external indicia of sex, and explicitly disavows any such
                reliance.\170\ Under the 2016 Rule, one can identify as ``male, female,
                neither, or a combination of male and female.'' A person's gender
                identity under the 2016 Rule is determined ultimately by what a person
                says his or her gender identity is, and a covered entity is bound to
                treat all individuals ``consistent with their gender identity'' the
                moment it becomes aware of such a declaration (which must be allowed to
                change under the 2016 Rule). No other Federal statute, agency rule, or
                guidance has ever gone so far on this question.\171\
                ---------------------------------------------------------------------------
                 \170\ 81 FR 31467 (``Gender identity means an individual's
                internal sense of gender'' whose expression ``may or may not conform
                to social stereotypes associated with a particular gender''); 81 FR
                31468 (``[sex] stereotypes can include the expectation that
                individuals will consistently identify with only one gender and that
                they will act in conformity with the gender-related expressions
                stereotypically associated with that gender.'') (emphasis added).
                 \171\ Cf. 18 U.S.C. 249 (Shepard-Byrd Hate Crimes Act) (defining
                gender identity as ``actual or perceived gender-related
                characteristics'').
                ---------------------------------------------------------------------------
                 In this regard, the 2016 Rule risked masking clinically relevant,
                and sometimes vitally important, information by requiring providers and
                insurers to switch from a scientifically valid and biologically based
                system of tracking sex to one based on subjective self-identification
                according to gender identity. By eliminating the transgender provisions
                and definitions from the 2016 Rule, this final rule clarifies that sex,
                according to the Title IX's plain meaning, may be taken into account in
                the provision of healthcare, insurance (including insurance coverage),
                and health research, as was the practice before the 2016 Rule.
                 Section 92.206 of the 2016 Rule required covered entities to
                ``treat individuals consistent with their gender identity'' in every
                respect save one. Namely, ``a covered entity may not deny or limit
                health services that are ordinarily or exclusively available to
                individuals of one sex, to a transgender individual based on the fact
                that the individual's sex assigned at birth, gender identity, or gender
                otherwise recorded is different from the one to which such health
                services are ordinarily or exclusively available.'' This confusingly
                worded exception is premised on the fact that entities may provide
                specific services to ``one sex'' based on biology, yet must grant
                transgender individuals access to such single-sex services regardless
                of how they identify and regardless of their sex (``sex assigned at
                birth''). The 2016 Rule's mandate cannot answer, for example, how a
                provider is to determine whether or when a transgender individual is
                entitled by law to be referred to a women's mental health support
                group, a men's mental health support group, either group, or both at
                the same time.
                 Some providers choose to code and track patients according to their
                biology for some purposes and according to their gender identity for
                other purposes. Under the 2016 Rule, however, if a transgender patient
                self-identifies as male in the medical intake process, yet an examining
                doctor has reason to believe the patient is biologically female, the
                doctor could reasonably assume that he or she is prohibited from
                changing the person's chart to reflect female sex, because that would
                not be treating the person ``consistent with'' her stated gender
                identity.
                 In the 2019 NPRM, the Department cited a 2019 case from a medical
                journal article that concluded that a nurse had applied longstanding
                standards when triaging what the article called a ``man with abdominal
                pain,'' who identified as male and had been classified as such, but who
                was in fact a pregnant woman.\172\ Because indications of pregnancy
                were not manifest, and because the patient was treated according to
                stated gender identity, her pregnancy was not diagnosed early, and the
                child was stillborn.
                ---------------------------------------------------------------------------
                 \172\ See 84 FR 27855, n. 55, citing Daphne Stroumsa, Elizabeth
                F.S. Roberts, et al., ''The Power and Limits of Classification--A 32
                Year Old Man with Abdominal Pain,'' New England Journal of Medicine
                (May 16, 2019), https://www.ncbi.nlm.nih.gov/pubmed/31091369 (a
                patient with an electronic medical record classification as male did
                not receive care to treat ``labor, placental abruption, or
                preeclampsia--urgent conditions presenting a potential emergency'').
                ---------------------------------------------------------------------------
                 This provider was treating the patient according to her stated
                gender identity (male), just as the 2016 Rule demanded. Indeed, the
                provider risked liability under the 2016 Rule for not taking that step.
                The provider did not act unreasonably when, consistent with
                longstanding medical practice, it did not have a policy of asking every
                man with abdominal pain whether he is pregnant.
                 Unlike the many strained hypothetical objections offered in
                opposition to the proposed rule, this case is not based on speculation.
                Rather,
                [[Page 37190]]
                it involved the actual death of an unborn child and attendant trauma
                and anguish for those involved, all potentially because of a
                misdiagnosis resulting from a reliance on stated gender identity as
                opposed to sex. Given that life-and-death decisions are frequently made
                in healthcare settings and often in urgent circumstances, this story
                serves as an example of the consequences that could result from the
                confusion caused by the 2016 Rule and its mandate to treat individuals
                ``consistent with'' stated gender identity.
                 Comment: Commenters stated that it is clear that characteristics
                traditionally protected under antidiscrimination law are those
                inherent, immutable, and readily identifiable. They stated that a
                binary and biological definition of sex enables consistency and clarity
                about who is a member of the protected category, what the prohibited
                conduct is, how covered entities must comply both by inaction and
                action, and when government enforces a right against discrimination.
                Commenters stated that changing the definition of the protected
                category to an identity that is changeable and fluid results in a legal
                standard that is impractical if not impossible to apply to particular
                circumstances. Commenters found that those courts that recognize gender
                identity discrimination apply the prohibitions inconsistently.
                 Healthcare providers submitted comments stating that ``gender
                identity'' is a subjective psychological concept that cannot be
                anatomically located within the brain, and that no MRI or CT scan,
                autopsy, genetic testing, blood test, or pathology report can localize
                an ``internal sense'' and verify whether the gender identity of a
                patient is actually male, female, neither, or a combination of male or
                female.
                 Commenters stated that they did not understand the categories in
                the 2016 Rule's definition of gender identity which are not obviously
                limited in the number of possible permutations nor anchored in biology.
                Commenters were concerned that Title IX's prohibitions against
                disparate treatment of biological women as different from biological
                males may no longer be prohibited or even enforceable. When a protected
                category that was binary now becomes a subjective spectrum, commenters
                did not know what the substantive standard was to establish a facial
                violation, or how to apply it to particular facts. Some commenters
                stated that it contradicts Title IX to treat sex as a non-binary
                concept when the statute explicitly protects persons of either ``one
                sex'' or ``the other sex.'' Commenters stated the 2016 Rule retained
                the words male or female--two categories which have long formed the
                biological and binary concept of sex--but eliminated their substantive
                content. The breadth of the definition of gender identity included both
                exterior (``expression'') and interior (``internal'' sense)
                characteristics; mental (``identity'') and physical (``body
                characteristics''); variable over time (at birth vs. after birth),
                feminine or masculine (binary), both (``some combination''), and
                androgyny (``neither''). Commenters stated that they did not have
                clarity as to how to assess claims of ``either/or'' disparate treatment
                as well as ``both/and.'' Commenters also noted the text also included
                an expansive catchall provision stating that the definition of gender
                identity ``is not limited to'' what was in that enumerated list.
                 Response: The Department agrees that gender identity is difficult
                to define, in some cases difficult to categorize, and frequently very
                difficult to determine with objective certainty. For these and reasons
                stated elsewhere, the 2016 Rule's provisions on gender identity were
                confusing facially and in application. This final rule eliminates that
                confusion by returning to the plain meaning of the underlying statutes,
                relying as it does on the plain meaning of ``sex'' as biologically
                binary.
                 Comment: The Department received comments stating that the proposed
                rule would harm the privacy interests of children with gender dysphoria
                who seek to use restrooms according to gender identity and would
                otherwise encourage bullying. Commenters also alleged that in Federal
                court cases concerning gender identity unrelated to health services,
                courts have rejected arguments about competing privacy concerns of non-
                transgender individuals with respect to bathroom access for transgender
                individuals.
                 Response: These comments show that, although the preamble to the
                2016 Rule had stated that it was not intended to overrule ``existing
                Federal, State and local laws, rules or regulations'' such as Title IX
                or its regulations, under which ``certain types of sex-specific
                facilities such as restrooms may be permitted'' such as bathrooms or
                intimate facilities,\173\ even the 2016 Rule's supporters can
                reasonably interpret its provisions as doing precisely that.
                ---------------------------------------------------------------------------
                 \173\ 81 FR 31409.
                ---------------------------------------------------------------------------
                 The Department acknowledges that there is new and developing case
                law on the intersection of privacy concerns of non-transgender
                individuals and bathroom access for transgender individuals.\174\ As
                commenters pointed out, there have been recent Title IX complaints
                regarding access to intimate facilities and associated case law. One
                complaint alleged a sexual assault by a male who identifies as female
                and had been granted access to a single-sex (female) facility based on
                stated gender identity.\175\ Another incident involved dueling
                discrimination and privacy complaints concerning the use of communal
                shower facilities. After filing a complaint, a male who identifies as
                female was granted an exception to live as a female. A group of females
                filed complaints that their privacy rights were violated.\176\ At least
                one Title IX complaint similar to these was denied by a court because
                of the specific facts of the case.\177\ But the case law on such
                complaints is very new and still developing.
                ---------------------------------------------------------------------------
                 \174\ See, e.g., Soule v. Conn. Ass'n of Schools, No. 3:20-cv-
                00201 (D. Conn. filed Feb. 12, 2020).
                 \175\ Moriah Balingit, ``After Alleged Sexual Assault, Officials
                Open Investigation of Transgender Bathroom Policy,'' The Washington
                Post (Oct. 9, 2018), https://www.washingtonpost.com/local/education/after-alleged-sexual-assault-officials-open-investigation-of-transgender-bathroom-policy/2018/10/09/431e7024-c7fd-11e8-9b1c-a90f1daae309_story.html.
                 \176\ See Department of Defense, ``Report and Recommendations,''
                37.
                 \177\ See Doe v. Boyertown Area Sch. Dist., 897 F.3d 518, 531-33
                (3d Cir. 2018).
                ---------------------------------------------------------------------------
                 The Department notes that, regardless of whether Title IX requires
                covered entities to maintain sex-specific bathrooms, the Title IX
                regulations continue to permit policies that regulate intimate
                facilities based on sex. These regulations are consistent both with the
                ordinary, biological understanding of the word ``sex'' as reflected
                throughout the text of Title IX and the ordinary understanding of
                discrimination. Indeed, as the U.S. government has noted, the
                provisions in Title IX stating that nothing in that statute prohibits
                educational institutions from ``maintaining separate living facilities
                for the different sexes'' ``could not sensibly function if `the term
                `sex' includes `gender identity,' which, unlike `sex,' may not be
                limited to two categories.'' \178\ Moreover, it has long been
                understood that, although ``separate bathrooms are obviously not blind
                to sex, they do not discriminate because of sex . . . so long as they
                do not treat men or women disadvantageously compared to the opposite
                sex.'' \179\ In light of experience, including experience since the
                2016 Rule was promulgated, the Department concludes that this final
                rule, by
                [[Page 37191]]
                removing the possibility that the Section 1557 regulations could be
                read as overruling Title IX's regulatory permission to maintain certain
                sex-segregated facilities (a permission consonant with Title IX's
                prohibition on sex discrimination, as explained above), will better
                permit covered entities to balance relevant privacy interests. The
                Department declines to retain a provision that could reasonably be read
                to prohibit covered entities from recognizing the difference between
                men and women or acting to protect men's and women's privacy interests
                in HHS-funded health programs or activities.\180\
                ---------------------------------------------------------------------------
                 \178\ Statement of Interest for DOJ, Soule v. Conn. Ass'n of
                Schools, 3:20-cv-00201-RNC (D. Conn., filed March 27, 2020) at 5.
                 \179\ Brief for EEOC, Harris Funeral Homes, at 36.
                 \180\ See OCR Voluntary Resolution Agreement with The Brooklyn
                Hospital Center (requiring assignment of persons to shared patient
                rooms according to gender identity) (2015), sub-regulatory guidance
                contained therein since abrogated, as discussed above, https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/vra.pdf.
                ---------------------------------------------------------------------------
                 Comment: Some commenters challenged the requirement under the 2016
                Rule that medical professionals must use a patient's preferred pronouns
                based entirely on self-identification, regardless of biological sex or
                the presence or absence of surgery or the use of masculinizing or
                feminizing hormone treatments. Some commenters disagreed with any
                requirement that forces providers to treat patients in a manner other
                than according to their biological sex, including through coerced use
                of pronouns. Others stated that social transition treatment required
                providers to use the preferred pronouns or preferred names of patients,
                and to identify patients according to their preferred sex effectively
                at all times.
                 Response: The 2016 Rule preamble held out a provider's ``persistent
                and intentional refusal to use a transgender individual's preferred
                name and pronoun and insistence on using those corresponding to the
                individual's sex assigned at birth'' as a potential example of hostile-
                environment sex discrimination under Section 1557.\181\ At least one
                district court has held similarly that when a provider allegedly
                ``continuously referred to'' a transgender patient ``with female
                pronouns'' in accordance with her sex, this could be sufficient grounds
                for a sex discrimination claim under Section 1557 in light of the Price
                Waterhouse ``stereotyping'' theory discussed above.\182\ This view,
                again, rested on a misreading of Title IX.
                ---------------------------------------------------------------------------
                 \181\ 81 FR 31406.
                 \182\ See Prescott v. Rady Children's Hospital-San Diego, 265 F.
                Supp. 3d 1090, 1098-100 (S.D. Cal. 2017) (``As other courts have
                recognized, `[b]y definition, a transgender individual does not
                conform to the sex-based stereotypes of the sex that he or she was
                assigned at birth. '. . . The Complaint alleges that the RCHSD staff
                discriminated against Kyler by continuously referring to him with
                female pronouns, despite knowing that he was a transgender boy and
                that it would cause him severe distress. . . . Accordingly, Ms.
                Prescott's claim on behalf of Kyler survives under [Section 1557 of]
                the ACA.'').
                ---------------------------------------------------------------------------
                 Pronouns are not stereotypes. Pronouns reflect the most elementary
                sex-based classification in the English language. They are routinely
                used in scientific contexts to refer to humans as well as any other
                animals that are either male or female. They identify an individual's
                sex, which is an essential element of determining sex-based
                discrimination under Title IX. This final rule does not interfere with
                the medical judgment of any covered entity in treating gender
                dysphoria, but Title IX cannot be used to require covered entities to
                ignore or override the underlying distinctions of sex that Title IX
                itself is premised upon.
                 The Department thus does not believe that Title IX requires
                participants in covered entities to use a pronoun other than the one
                consistent with an individual's sex and does not believe it otherwise
                appropriate to dictate pronoun use or force covered entities to
                recognize a conception of sex or gender identity with which they
                disagree for medical, scientific, religious, and/or philosophical
                reasons. This final rule does not prevent covered entities from
                maintaining or adopting pronoun policies, or endorsing a variety of
                theories of gender identity, to the extent otherwise allowed by
                statutory and constitutional law. This rule also does not prevent State
                and local jurisdictions from imposing such policies to the extent
                allowed by statutory and constitutional law.
                 Comment: A commenter contended that the Department exceeded its
                authority by proposing to roll back protections for transgender
                individuals, noting that a 2012 letter from OCR stated that Section
                1557 protections included gender identity.\183\
                ---------------------------------------------------------------------------
                 \183\ See Letter from Leon Rodriguez, Director, U.S. Dep't of
                Health & Human Servs., Office for Civil Rights, to Maya Rupert,
                Federal Policy Director, National Center for Lesbian Rights (Jul.
                12, 2012), available at https://perma.cc/RB8V-ACZU.
                ---------------------------------------------------------------------------
                 Response: Consistent with the position taken by the Executive
                Branch on Title IX since 2017, the Department has concluded that the
                position stated in the 2012 OCR letter reflected an incorrect
                understanding of Title IX, as incorporated into Section 1557. The
                Department indefinitely suspended the sub-regulatory guidance contained
                in the 2012 letter in light of the proposed changes to the rule. 84 FR
                27872 n.175. Having considered the matters raised fully, the Department
                disavows the views expressed in the 2012 letter that concern the
                coverage of gender identity and sex discrimination under Section 1557.
                Similarly, the Department disavows the views expressed in a voluntary
                resolution agreement entered into with The Brooklyn Hospital Center in
                2015 resolving allegations of gender identity discrimination under
                Section 1557.\184\ To the extent that those views were integrated or
                incorporated into the 2016 Rule with respect to gender identity, they
                are rescinded in this final rule.
                ---------------------------------------------------------------------------
                 \184\ See OCR Voluntary Resolution Agreement with The Brooklyn
                Hospital Center.
                ---------------------------------------------------------------------------
                 Comment: Many commenters asserted that the proposed rule removes
                legal protections for transgender individuals and would allow or
                encourage providers to deny basic healthcare to individuals who
                identify as transgender. Commenters pointed to what they said were
                instances of discrimination on the basis of the identity of the patient
                as a transgender individual, where providers allegedly used excessive
                precautions, avoided touching the patient, engaged in unnecessary
                physical roughness in pelvic examinations, made insensitive jokes,
                intentionally concealed information about options for different
                treatments, asked unnecessarily personal questions, referred to
                transgender patients by pronouns and terms of address based on their
                biological sex rather than their gender identity, and/or disclosed a
                patient's medical history without authorization. Others cited 15 closed
                cases handled by OCR of alleged discrimination against transgender
                individuals in which providers had refused sex-specific care or
                coverage on the basis of discrepancies between the individual's sex and
                stated gender identity.
                 Response: The Department believes that all people should be treated
                with dignity and respect, regardless of their characteristics including
                their gender identity, and they should be given every protection
                afforded by the Constitution and the laws passed by Congress. The
                Department is committed to fully and vigorously enforcing all of the
                nondiscrimination statutes entrusted to it by Congress. For reasons
                explained above, the term ``on the basis of . . . sex'' in Section 1557
                does not encompass discrimination on the basis of gender identity.
                Unprofessional conduct such as inappropriate jokes or questions,
                excessive precautions, or concealment of treatment options, may be
                covered under State medical malpractice, tort, or battery laws.
                 Commenters' concern about denial of basic healthcare to transgender
                [[Page 37192]]
                individuals appears to be based largely on unsubstantiated hypothetical
                scenarios. Although some rare instances have been reported, they are
                not recent, and the Department is unaware of a significant number of
                cases where a transgender individual who has accurately identified his
                or her (biological) sex to a provider has nonetheless been denied
                relevant, non-transition-related healthcare on the basis of his or her
                gender identity. The Department is not aware of any providers claiming
                that they see a need for or wish to make broad, identity-based denials
                of care. To the contrary, many providers who specifically object to the
                2016 Rule's mandates with respect to sex-reassignment treatments and/or
                elective abortion procedures explicitly affirmed in comments their
                commitment to treat all patients without regard to self-identification,
                inclusive of gender identity or sexual orientation. In the anecdotes of
                discrimination reported by commenters, what is often being alleged is
                poor care or insensitive treatment rather than outright denial of care,
                and is often lacking documentation. This lack of substantial evidence
                supports the Department's understanding, in contrast to the allegations
                of some commenters, that denial of basic healthcare on the basis of
                gender identity is not a widespread problem in the U.S. Moreover, to
                the extent that the 2016 Rule provided against denial of basic
                healthcare on the basis of gender identity, those provisions of the
                rule have been preliminarily enjoined since December 2016 and have
                since been vacated; any future mistreatment hypothesized by commenters
                would not, then, be the result of this final rule.
                 Additionally, several of the behaviors alleged by commenters would
                be unlawful even if Title IX and Section 1557 had never been enacted.
                Unnecessary roughness in a pelvic examination, or any other medical
                procedure or examination without a medical basis or appropriate
                informed consent, may be a case of battery or malpractice, which should
                be reported to local law enforcement and/or licensing authorities. If
                such conduct willfully causes bodily injury because of gender identity,
                and is in or affecting interstate commerce, then it could be a Federal
                hate crime.\185\ When OCR becomes aware of any crimes that may violate
                Federal law, it may be required to make a referral to the Department of
                Justice.\186\ The Emergency Medical Treatment and Labor Act (EMTALA)
                also requires stabilization in certain emergency medical situations.
                ---------------------------------------------------------------------------
                 \185\ 18 U.S.C. 249(c)(4) (prohibiting hate crimes that are
                based on ``actual or perceived religion, national origin, gender,
                sexual orientation, gender identity, or disability'').
                 \186\ See 34 U.S.C. 41303 (``All departments and agencies within
                the Federal government . . . shall report details about crime within
                their respective jurisdiction to the Attorney General''); 28 U.S.C.
                535(b) (``any information, allegation, or complaint received in a
                department or agency of the executive branch of government relating
                to violations of title 28 involving Government officers and
                employees shall be expeditiously reported to the Attorney General by
                the head of the department or agency'').
                ---------------------------------------------------------------------------
                 OCR also continues to enforce Federal health information privacy
                laws to ensure the confidentiality of all individuals' protected
                medical information, including information concerning gender dysphoria
                diagnosis or treatment, sexual orientation, or HIV status.\187\
                ---------------------------------------------------------------------------
                 \187\ See U.S. Department of Health and Human Services,
                ``Careless handling of HIV information jeopardizes patient's
                privacy, costs entity $387k'' (May 23, 2017), available at https://www.hhs.gov/about/news/2017/05/23/careless-handling-hiv-information-costs-entity.html (OCR enforcement under HIPAA); see also U.S.
                Department of Health and Human Services, ``HHS Office for Civil
                Rights Secures Corrective Action and Ensures Florida Orthopedic
                Practice Protects Patients with HIV from Discrimination'' (Oct. 30,
                2019), https://www.hhs.gov/about/news/2019/10/30/hhs-ocr-secures-corrective-action-and-ensures-fl-orthopedic-practice-protects-patients-with-hiv-from-discrimination.html (OCR enforcement under
                Section 504 and Section 1557).
                ---------------------------------------------------------------------------
                 The Department, through its Offices of Minority Health, supports
                outreach to diverse populations and those facing particularized or
                disproportionate health challenges.
                 Comment: Commenters alleged that removing the definitions of
                ``gender identity'' and ``on the basis of sex'' (which includes gender
                identity) from the rule would ``erase'' transgender individuals from
                the Code of Federal Regulations.
                 Response: The Department denies that removal of definitional terms
                in one regulation has the wide-ranging impact that commenters allege.
                Under this final rule, transgender individuals remain protected by the
                same civil rights laws as any other individual, and the Department will
                vigorously enforce their statutory and regulatory civil rights. This
                final rule also does not and cannot erase explicit statutory
                protections for individuals on the basis of gender identity, such as in
                hate crimes laws that bar violence committed on the basis of an
                individual's gender identity.\188\
                ---------------------------------------------------------------------------
                 \188\ See 18 U.S.C. 249(c)(4) (prohibiting hate crimes that are
                based on ``actual or perceived religion, national origin, gender,
                sexual orientation, gender identity, or disability'').
                ---------------------------------------------------------------------------
                iii. Termination of Pregnancy
                 Comment: Commenters reacted to the proposed rule's elimination of
                the 2016 Rule's language that had encompassed ``termination of
                pregnancy'' within the definition of ``on the basis of sex.''
                Commenters stated that the Department's declining to take a position
                about the full scope of the meaning of ``termination of pregnancy'' in
                the 2019 NPRM was confusing, and that the point merited clarification.
                Some providers objected to the inclusion of ``termination of
                pregnancy'' under the 2016 Rule to the extent that it referred to
                elective abortions. Other providers interpreted ``termination of
                pregnancy'' to mean both elective abortion and natural termination of
                pregnancies. Others stated that all forms of termination of pregnancy
                should be encompassed in the prohibition on discrimination on the basis
                of sex.
                 Some commenters stated that removing the 2016 Rule's definition of
                ``on the basis of sex'' will allow discrimination against women based
                upon their abortion history. Commenters also identified a variety of
                other women's healthcare services related to pregnancy that may be
                implicated, including prenatal and postpartum services, tubal
                ligations, and birth control (both as a contraceptive and when used to
                treat other medical conditions). They also referred to infertility
                treatments including in vitro fertilization, and pointed to Benitez v.
                North Coast Women's Care Medical Group, Inc.\189\ as a real-world
                example of discrimination in this regard. Commenters said that the
                proposed rule would or could permit discrimination against women
                through denial or restriction of access to treatments such as these, as
                well as treatments prior to, during, or after a miscarriage.
                ---------------------------------------------------------------------------
                 \189\ Benitez v. N. Coast Women's Care Med. Grp., Inc., 106 Cal.
                App. 4th 978 (Mar. 4, 2003).
                ---------------------------------------------------------------------------
                 Response: Under this final rule, the Department will interpret
                Section 1557's prohibition on sex-based discrimination consistent with
                Title IX and its implementing regulations. This final rule ensures that
                the Department's Section 1557 regulations are implemented consistent
                with the abortion neutrality and statutory exemptions in Title IX. The
                regulations are subject to the text of the Title IX statute, so they
                cannot be ``construed to require or prohibit any person, or public or
                private entity, to provide or pay for any benefit or service, including
                the use of facilities, related to an abortion.'' 20 U.S.C. 1688. As
                explained below, this final rule also incorporates that statutory text
                explicitly into the Title IX regulations for the sake of clarity, to
                ensure those regulations are
                [[Page 37193]]
                implemented consistent with the statute.
                 The Franciscan Alliance court vacated the ``termination of
                pregnancy'' language in the 2016 Rule because it failed to incorporate
                the abortion-neutrality language from the Title IX statute.\190\ The
                Court held that ``Congress intended to incorporate the entire statutory
                structure, including the abortion and religious exemptions,'' \191\ and
                concluded that by failing to include these exemptions, the Department
                unlawfully ``expanded the `ground prohibited under' Title IX that
                Section 1557 explicitly incorporated.'' \192\
                ---------------------------------------------------------------------------
                 \190\ Franciscan Alliance, 227 F. Supp. 3d 660, 690-91 (N.D.
                Tex. 2016) (``Title IX prohibits discrimination on the basis of sex,
                but . . . . categorically exempts any application that would require
                a covered entity to provide abortion or abortion-related services.
                20 U.S.C. 1688. . . . Failure to incorporate Title IX's religious
                and abortion exemptions nullifies Congress's specific direction to
                prohibit only the ground proscribed by Title IX. That is not
                permitted.''); Franciscan Alliance, 414 F. Supp. 3d 928, 945, 947
                (N.D. Tex. 2019) (adopting reasoning from preliminary injunction and
                vacating the portions of the rule it deemed unlawful).
                 \191\ Franciscan Alliance, 227 F. Supp. 3d at 690-91.
                 \192\ Id. (citing Corley v. U.S., 556 U.S. 303, 314 (2009)).
                ---------------------------------------------------------------------------
                 The Department is committed to enforcing vigorously the prohibition
                on discrimination on the basis of sex, through its implementing
                regulations (which include provisions on termination of pregnancy), as
                interpreted consistent with the text of Title IX. OCR will fully
                enforce its statutory authorities concerning any discriminatory denial
                of access to women's health services, including those related to
                pregnancy. The Department, however, declines to speculate on particular
                hypotheticals related to termination of pregnancy, and will proceed
                based on the specific facts and circumstances of each case that may
                arise.
                 Comment: Some commenters stated that without the 2016 Rule, there
                would be serious and/or life-threatening results because hospitals
                would not provide abortion care on the basis of religious beliefs,
                referencing ACLU v. Trinity Health Corporation, 178 F. Supp. 3d 614
                (E.D. Mich. 2016), and Means v. U.S. Conference of Catholic Bishops,
                No. 1:15-CV-353, 2015 WL 3970046 (W.D. Mich. 2015). Some alleged that
                the proposed rule does not comply with constitutional law regarding
                abortion or the applicable standard of scrutiny for sex discrimination
                and imposes undue burdens on women. Some stated that the proposed rule
                would hurt women's health by denying or encouraging denial of access to
                abortion.
                 Others submitted evidence challenging the idea that the termination
                of pregnancy provision, if retained (and not enjoined by a court),
                would materially increase abortion access for the average person.
                Specifically, they state that the overwhelming majority of abortions in
                America are performed at high-volume abortion clinics, and that there
                is no reason to suspect that retaining the 2016 Rule would lead to a
                significant increase in hospitals or other institutions willing to
                perform abortions when compared to abortion providers as a whole.
                According to commenters, this is in part because many hospitals and
                medical institutions that do not have a formal position objecting to
                abortion are free to engage in them now yet do not perform them or do
                so only to a limited extent.\193\ Additionally, commenters said that
                the relative dearth of doctors willing to perform abortions at
                institutions appears largely to be a result of independent physician
                choices, not of the policies of institutions that object to abortions.
                ---------------------------------------------------------------------------
                 \193\ As one commenter wrote, ``A 2018 study in the journal
                Contraception found that only 7% of obstetrician-gynecologists in
                private practice had performed an abortion in 2013 or 2014. An older
                study published in 2011 in Obstetrics and Gynecology found that 97%
                of practicing obstetrician-gynecologists encountered patients
                seeking an abortion, though only 14% performed them. Finally, a 2014
                study published in Perspectives on Sexual and Reproductive Health
                found that just 5% of abortions take place in hospitals or
                physicians' offices, demonstrating that the vast majority of
                abortions are not performed by healthcare providers at hospitals or
                physicians' offices.''
                ---------------------------------------------------------------------------
                 Some commenters were concerned that the 2016 Rule's provisions on
                termination of pregnancy devalue human life, both with respect to
                unborn children who lose their lives, and with respect to mothers, as
                many abortions are dangerous and lead to life-threatening complications
                for women. Other commenters stated that HHS has a compelling interest
                in defending the sanctity of innocent human life at all stages. Some
                institutional providers who object to abortion stated that they can and
                do treat women who have had miscarriages, even using techniques that
                are commonly used in abortion (such as dilation and curettage), so long
                as the procedure itself is not intended to and does not result in the
                taking of a human life.
                 Response: The Department appreciates all comments related to the
                highly controversial matter of abortion. The strong views that
                Americans hold on various sides of this question are an important
                policy reason supporting the Congressionally-enacted abortion-
                neutrality language in Federal statutes such as Title IX. Because
                Section 1557 expressly incorporated Title IX--therefore including the
                abortion-neutrality provision--the Department likewise incorporates
                that provision for purposes of the covered entities under Section 1557.
                This final rule also does not add any abortion-related conscience
                protections beyond those that Congress has set down in statute. Those
                statutes have not been held to be unconstitutional. The Department will
                vigorously enforce these and all other Federal civil rights statutes
                under its jurisdiction.
                 This final rule also does not abrogate other longstanding Federal
                laws that may apply to situations related to pregnancy, including
                EMTALA and the Pregnancy Nondiscrimination Act. The Department will
                read all applicable laws and exemptions harmoniously.\194\ In addition,
                the termination of pregnancy provisions of the 2016 Rule have been
                enjoined since December 2016 and are now vacated. Finally, this rule
                does not change the legal ability of providers to offer abortions. The
                Department therefore disagrees with commenters who predict that the
                finalization of this rule will significantly reduce abortion access or
                cause resulting health consequences.
                ---------------------------------------------------------------------------
                 \194\ See 42 U.S.C. 13955dd(c)(1)(ii) (EMTALA); Public Law 95-
                555, 92 Stat. 2076 (Oct. 31, 1978) (Pregnancy Nondiscrimination
                Act).
                ---------------------------------------------------------------------------
                iv. Sexual Orientation
                 Comment: Some commenters stated that the 2016 Rule's Sec. 92.209
                should be removed because Title VII and Title IX do not include sexual
                orientation in their prohibition of sex discrimination. They used as an
                example the fact that the previous Administration treated sex, sexual
                orientation, and gender identity as different concepts in an executive
                order that prohibited discrimination on the basis of sex, sexual
                orientation, and gender identity in Federal hiring, contracting, and
                employment.\195\ They added that Congress has rejected the sexual
                orientation and gender identity provisions in the Employment Non-
                Discrimination Act, the Equality Act, and the Student Non-
                Discrimination Act.
                ---------------------------------------------------------------------------
                 \195\ Exec. Order No. 13672, 79 FR 42971-72 (July 21, 2014),
                https://www.govinfo.gov/content/pkg/FR-2014-07-23/pdf/2014-17522.pdf.
                ---------------------------------------------------------------------------
                 Others said that sexual orientation is a foundational trait of an
                individual and that cannot be separated and/or isolated from his or her
                being and that the proposed rule would enable discrimination based on
                sexual orientation. Other commenters cite a general fear of
                discrimination; abuse or neglect related to sexual orientation; a
                [[Page 37194]]
                lack of inclusive services; social isolation; a sense of invisibility;
                lack of educated providers; and distrust of the healthcare system. They
                argue that these burdens lead to inadequate care, including preventive
                care, and require a Federal response. In support of these claims,
                commenters cited a survey stating that 8% of lesbian, gay, and bisexual
                respondents allege they have been refused care from a healthcare
                provider due to their sexual orientation.\196\ Other commenters,
                however, cited a survey showing that 97% of responding faith-based
                medical professionals attest that they ``care for all patients in need,
                regardless of sexual orientation, gender identification, or family
                makeup, with sensitivity and compassion, even when [they] cannot
                validate their choices.'' \197\ Thus, some commenters argue, the issue
                is not one of refusing to care for certain patients based on identity,
                but instead a matter of declining to participate in a discrete set of
                morally controversial procedures and treatments that are available
                elsewhere.
                ---------------------------------------------------------------------------
                 \196\ See Shabab Ahmed Mirza and Caitlin Rooney, Discrimination
                Prevents LGBTQ People from Accessing Health Care, Center for
                American Progress (January 18, 2018), https://www.americanprogress.org/issues/lgbt/news/2018/01/18/445130/discrimination-prevents-lgbtq-people-accessing-health-care/.
                 \197\ See Freedom2Care, ``Conscience in healthcare: 2019,''
                https://www.freedom2care.org/polling.
                ---------------------------------------------------------------------------
                 Others said that discrimination because of an individual's sexual
                orientation is plainly a species of sex stereotyping that is
                impermissible under Section 1557's sex discrimination prohibition and
                cite Baldwin v. Foxx, an EEOC decision,\198\ in support of the idea
                that the final rule should cover sexual orientation.
                ---------------------------------------------------------------------------
                 \198\ Baldwin v. Foxx, EEOC Appeal No. 0120133080, 2015 WL
                4397641 (July 15, 2015).
                ---------------------------------------------------------------------------
                 Response: OCR may only enforce laws that Congress has enacted and
                the regulations that were promulgated pursuant to that statutory
                authority. The plain meaning of ``sex'' under Title IX encompasses
                neither sexual orientation nor gender identity. Concerning commenters'
                discussion of Congress's failure to add sexual orientation and gender
                identity to contexts encompassed by Title IX or Title VII, the
                Department is guided primarily by its understanding of the plain
                meaning of the statute.\199\ This final rule does not change the status
                quo with respect to sexual orientation, because, as the Department
                stated in the 2019 NPRM preamble, sexual orientation was not explicitly
                included in the 2016 Rule text,\200\ and the Department has concluded
                that it is a category separate from sex and does not fall within the
                ambit of discrimination ``on the basis of sex.''
                ---------------------------------------------------------------------------
                 \199\ The Department agrees that Congressional inaction on this
                issue is supportive of the conclusion that Title IX does not
                encompass sexual orientation or gender identity, although it does
                not rely on this Congressional inaction in interpreting Title IX.
                 \200\ 81 FR 31390 (``OCR has decided not to resolve in this rule
                whether discrimination on the basis of an individual's sexual
                orientation status alone is a form of sex discrimination.'').
                ---------------------------------------------------------------------------
                 The U.S. Attorney General and Solicitor General have persuasively
                argued that Price Waterhouse does not elevate sexual orientation to a
                protected category using a sex stereotyping theory under Title VII,
                just as it fails to make gender identity a protected category under
                Title IX.\201\ Much as the reasonable distinctions on the basis of sex
                discussed above (in the subsection on gender identity) are not
                illegitimate sex stereotypes, so too, distinctions on the basis of
                sexual orientation do not as such constitute sex stereotyping. As an
                initial matter, distinctions on the basis of sexual orientation may be
                sex-neutral and apply equally to both sexes, which would mean that they
                do not burden anyone on the basis of sex. The Eleventh Circuit has
                recently rejected the application of Price Waterhouse to expand ``sex''
                to include ``sexual orientation,'' citing an abundance of case law in
                support.\202\ Additionally, as the Solicitor General has argued,
                distinctions made on the basis of sexual orientation are not
                necessarily based on stereotypes, as they may instead be based on
                ``moral or religious beliefs about sexual, marital, and familial
                relationships.'' \203\ ``There is nothing irrational or improper'' in
                such beliefs.\204\
                ---------------------------------------------------------------------------
                 \201\ See Bostock v. Clayton Cty. Bd. of Commissioners, 2019 WL
                4014070 at *26 (U.S. 2019) (Brief for the United States as Amicus
                Curiae Supporting Affirmance in No. 17-1618 (Bostock v. Clayton Cty.
                Bd. of Commissioners) and Reversal in No. 17-1623 (Altitude Express
                Inc. v. Zarda)) (``Title VII prohibits disparate treatment of men
                and women regardless of sexual orientation. Gay, lesbian, and
                bisexual employees, no less than straight employees, may invoke
                Price Waterhouse if they are subjected to gender-based stereotypes;
                a gay man who is fired for being too effeminate has just as strong a
                claim as a straight man who is fired for that reason.''). See also
                Etsitty v. Utah Transit Authority, 502 F.3d 1215, 1224-25 (10th Cir.
                2007) (explaining that the legal issue ``is whether members of one
                sex are exposed to disadvantageous terms or conditions of employment
                to which members of the other sex are not exposed'').
                 \202\ Evans v. Georgia Reg'l Hosp., 850 F.3d 1248, 1256-57 (11th
                Cir. 2017) (``Price Waterhouse and Oncale are neither clearly on
                point nor contrary to Blum [v. Gulf Oil Corp., 597 F.2d 936 (5th
                Cir. 1979) (``Discharge for homosexuality is not prohibited by Title
                VII. . . .'')]. These Supreme Court decisions do not squarely
                address whether sexual orientation discrimination is prohibited by
                Title VII.'') Id. at 1256-57 (``Finally, even though they disagree
                with the decisions, [the plaintiffs] acknowledge that other circuits
                have held that sexual orientation discrimination is not actionable
                under Title VII. See, e.g., Higgins v. New Balance Athletic Shoe,
                Inc., 194 F.3d 252, 259 (1st Cir. 1999) (``Title VII does not
                proscribe harassment simply because of sexual orientation.'');
                Simonton v. Runyon, 232 F.3d 33, 36 (2d Cir. 2000) (``Simonton has
                alleged that he was discriminated against not because he was a man,
                but because of his sexual orientation. Such a claim remains non-
                cognizable under Title VII.''); Bibby v. Phila. Coca Cola Bottling
                Co., 260 F.3d 257, 261 (3d Cir. 2001) (``Title VII does not prohibit
                discrimination based on sexual orientation.''); Wrightson v. Pizza
                Hut of Am., 99 F.3d 138, 143 (4th Cir. 1996), abrogated on other
                grounds by Oncale v. Sundowner Offshore Servs., 523 U.S. 75, 118 S.
                Ct. 998, 140 L.Ed.2d 201 (1998) (``Title VII does not afford a cause
                of action for discrimination based upon sexual orientation. . .
                .''); Vickers v. Fairfield Med. Ctr., 453 F.3d 757, 762 (6th Cir.
                2006) (``[S]exual orientation is not a prohibited basis for
                discriminatory acts under Title VII.''); Hamner v. St. Vincent Hosp.
                & Health Care Ctr., Inc., 224 F.3d 701, 704 (7th Cir. 2000)
                (``[H]arassment based solely upon a person's sexual preference or
                orientation (and not on one's sex) is not an unlawful employment
                practice under Title VII.''); Williamson v. A.G. Edwards & Sons,
                Inc., 876 F.2d 69, 70 (8th Cir. 1989) (``Title VII does not prohibit
                discrimination against homosexuals.''); Rene v. MGM Grand Hotel,
                Inc., 305 F.3d 1061, 1063-64 (9th Cir. 2002) (``[A]n employee's
                sexual orientation is irrelevant for purposes of Title VII. It
                neither provides nor precludes a cause of action for sexual
                harassment. That the harasser is, or may be, motivated by hostility
                based on sexual orientation is similarly irrelevant, and neither
                provides nor precludes a cause of action.''); Medina v. Income
                Support Div., 413 F.3d 1131, 1135 (10th Cir. 2005) (``Title VII's
                protections, however, do not extend to harassment due to a person's
                sexuality. . . . Congress has repeatedly rejected legislation that
                would have extended Title VII to cover sexual orientation.'')
                (internal quotations omitted). Evans and the EEOC question these
                decisions, in part, because of Price Waterhouse and Oncale. Whether
                those Supreme Court cases impact other circuit's decisions, many of
                which were decided after Price Waterhouse and Oncale, does not
                change our analysis that Blum is binding precedent that has not been
                overruled by a clearly contrary opinion of the Supreme Court or of
                this Court sitting en banc.'').
                 \203\ Bostock v. Clayton Cty. Bd. of Commissioners, 2019 WL
                4014070 at *25 (U.S. 2019) (Brief for the United States as Amicus
                Curiae Supporting Affirmance in No. 17-1618 (Bostock v. Clayton Cty.
                Bd. of Commissioners) and Reversal in No. 17-1623 (Altitude Express
                Inc. v. Zarda)).
                 \204\ See Tuan Anh Nguyen v. INS, 533 U.S. 68. See also
                Obergefell v. Hodges, 135 S. Ct. 2585, 2602 (2015) (referring to
                opinions that are ``based on decent and honorable religious or
                philosophical premises'' and are therefore not ``disparaged here'');
                See Masterpiece Cakeshop v. Colorado Civil Rights Comm'n, 138 S. Ct.
                1719, 1729 (2018) (``To describe a man's faith as `one of the most
                despicable pieces of rhetoric that people can use' is to disparage
                his religion in at least two distinct ways: by describing it as
                despicable, and also by characterizing it as merely rhetorical--
                something insubstantial and even insincere.'').
                ---------------------------------------------------------------------------
                 The Department notes that in Baldwin v. Foxx, the EEOC reversed its
                long-held position that sexual orientation discrimination was not
                protected under Title VII.\205\ The United States government has since
                rejected the
                [[Page 37195]]
                EEOC's novel position.\206\ Given Congress's decision not to extend
                civil rights protections on the basis of sexual orientation in the
                field of health and human services, the Department believes that State
                and local governments are best equipped to balance the multiple
                competing considerations involved in what remain a contentious and
                fraught set of questions.
                ---------------------------------------------------------------------------
                 \205\ See e.g., Angle v. Veneman, EEOC Decision No. 01A32644,
                2004 WL 764265, at *2 (Apr. 5, 2004) (recognizing that the EEOC had
                ``consistently held that discrimination based on sexual orientation
                is not actionable under Title VII''), Marucci v. Caldera, EEOC
                Decision No. 01982644, 2000 WL 1637387, at *2-*3 (Oct. 27, 2000).
                 \206\ See Brief for United States, Bostock v. Clayton Cty. Bd.
                of Commissioners, No. 17-1618 (U.S. filed Aug. 23, 2019).
                ---------------------------------------------------------------------------
                v. Scrutiny for Sex-Based Classifications (Repeal of Sec.
                92.101(b)(3)(iv) of the 2016 Rule)
                 The Department proposed to repeal 92.101(b)(3)(iv) of the 2016
                Rule, which forbids covered entities from operating a health program or
                activity restricted to members of one sex unless they can ``demonstrate
                an exceedingly persuasive justification, that is, that the sex-specific
                health program or activity is substantially related to the achievement
                of an important health-related or scientific objective.'' \207\
                ---------------------------------------------------------------------------
                 \207\ 81 FR 31470.
                ---------------------------------------------------------------------------
                 Comment: Commenters stated that the 2016 Rule's provisions would
                pose an unjustified burden on, and lead to excessive scrutiny of,
                entities operating single-sex facilities in healthcare, as well as
                entities or persons who would claim religious or abortion exemptions
                under Title IX.
                 Response: The Department agrees that the 2016 Rule placed an
                unjustified burden on sex-specific health programs and activities
                conducted by private entities. The ``exceedingly persuasive
                justification'' legal standard under Equal Protection jurisprudence
                sets a limit to governmental actions that discriminate on the basis of
                sex, such as the military draft.\208\ This standard is foreign to Title
                IX jurisprudence.\209\ The 2016 Rule cited no case law in support of
                its decision to import a significantly modified version of this
                standard from constitutional law into its interpretation of ``on the
                basis of sex'' as defined by Title IX.\210\ The express statutory
                exemptions to Title IX's nondiscrimination provisions, such as for
                fraternities and sororities, do not require individual covered entities
                to provide an ``exceedingly persuasive justification'' before being
                able to benefit from the exemption. Title IX also does not require
                religious entities to provide such a justification to qualify for the
                religious exemption from Title IX nondiscrimination provisions. To
                require such a justification in the enforcement of Section 1557 would
                be to impose a significant burden on private entities that the
                statutory text does not contemplate. Government actors are routinely
                subjected to levels of judicial scrutiny that private parties (even
                private parties receiving Federal funds) are not, such as where
                constitutional provisions restrict government action, or where statutes
                allow civil rights actions against State actors. See, e.g., 1st Am.,
                U.S. Const.; 42 U.S.C. 1983; 42 U.S.C. 2000bb, et seq. It would be
                inappropriate to constrain medical professionals' best judgment by
                requiring them to meet the governmental burden of proof every time they
                seek to draw a reasonable distinction on the basis of sex in providing
                healthcare or separate programs or activities for the two sexes.\211\
                As stated above, such distinctions are not inherently discriminatory:
                It is not discriminating against men to exclude them from, for example,
                gynecological services, because men are not similarly situated to women
                for purposes of such services. Providers accordingly should not be
                required to present an ``exceedingly persuasive justification'' for
                providing gynecological services only to women. OCR will, however,
                evaluate, and respond appropriately to, any allegations that a covered
                entity's sex-specific health programs or activities have in fact
                discriminated unlawfully on the basis of sex, including sexual
                harassment.\212\
                ---------------------------------------------------------------------------
                 \208\ See Rostker v. Goldberg, 453 U.S. 57, 69-70 (1981).
                 \209\ See, e.g., the clear distinction at Whitaker v. Kenosha
                Unified Sch. Dist., 858 F.3d 1034, 1046-50 (7th Cir. 2017) (``Title
                IX Claim''), and 1050-54 (``Equal Protection Claim,'' encompassing
                the ``exceedingly persuasive justification'' test).
                 \210\ Cf. 81 FR 31408-09.
                 \211\ See 2016 Rule, 81 FR 31409 (``In all cases, . . . OCR will
                expect a covered entity to supply objective evidence, and empirical
                data if available, to justify the need to restrict participation in
                the program to only one sex.'').
                 \212\ See U.S. Department of Health and Human Services, ``HHS
                OCR Secures Agreement with MSU to Resolve Investigation into Sexual
                Abuse by Larry Nassar'' (2019), https://www.hhs.gov/about/news/2019/08/12/hhs-ocr-secures-agreement-msu-resolve-investigation-sexual-abuse-larry-nassar.html.
                ---------------------------------------------------------------------------
                vi. Disparate Impact Under Sec. 92.101(b)(3)(iii) of the 2016 Rule
                 The Department proposed to repeal 92.101(b)(iii) of the 2016 Rule,
                which prohibited selection of sites or facilities that have an effect
                of discriminating on the basis of sex.\213\
                ---------------------------------------------------------------------------
                 \213\ 81 FR 31470.
                ---------------------------------------------------------------------------
                 Comment: Some commenters opposed repealing language that affirmed a
                disparate impact theory under grounds of nondiscrimination encompassed
                by Section 1557, contending that the civil rights statutes cited in
                Section 1557 authorize disparate impact claims.
                 One commenter asserted that the very existence of Section 1557
                indicates that the ACA intends to extend protections against disparate
                impact discrimination to private rights of action: Title VI already
                applied in the context of healthcare programs and activities, so
                Section 1557 would have been meaningless if it did not also allow for
                private rights of action for disparate impact discrimination. The same
                commenter also took issue with the proposed rule's elimination of
                monetary damages for disparate impact claims.
                 Response: Case law has indicated that certain civil rights statutes
                incorporated by Section 1557 do authorize disparate impact claims:
                Namely, claims with respect to discrimination on the basis of race,
                color, national origin, and disability.\214\ Title IX, however,
                authorizes no such claims regarding discrimination on the basis of sex.
                Similarly, provisions relating to site or facility selection based on
                race, color, national origin, or disability are found in HHS's Title VI
                and Section 504 regulations, but are not found in HHS's Title IX
                regulations.\215\ Insofar as the 2016 Rule added new grounds of
                prohibited discrimination not found in the statute, the Department
                believes it is necessary to revert to the underlying statutes and their
                implementing regulations. As a result, to the extent any of the
                underlying statutes authorize disparate impact claims, this final rule
                will recognize such claims by virtue of its reliance on the governing
                statutes, regulations, guidance and case law applicable to such claims,
                without needing to delineate the availability or lack of availability
                of all possible claims in this final rule. In reviewing all complaints
                that raise a disparate impact claim, the Department will consider the
                circumstances of each complaint and will independently apply each
                statute and underlying regulation, according to its text and any
                applicable court precedents, to the health context under Section
                1557.\216\
                ---------------------------------------------------------------------------
                 \214\ See 45 CFR 84.4(b)(4) (Title VI); 80.3(b)(2) (Section
                504).
                 \215\ See 45 CFR 80.3(b)(3) (Title VI); 84.4(b)(5) (Section
                504).
                 \216\ The Department responds to comments on private rights of
                action and damages below in the section on the enforcement
                mechanisms of the 2016 Rule.
                ---------------------------------------------------------------------------
                 Comment: Some commenters stated that that the proposed rule's
                removal of protections against disparate impact discrimination,
                especially concerning race, color, and national origin, will lead to
                more instances of discrimination and fewer means of recourse.
                [[Page 37196]]
                Commenters cited data about health disparities in LGBT and female
                populations that they asserted were caused by discrimination on the
                basis of gender identity or termination of pregnancy, and stated that
                disparate impact analysis under the 2016 Rule is the appropriate way to
                address such discrimination. Another commenter questioned the
                persuasiveness of assessing the relative proportion of health
                disparities between racial, transgender, and/or female populations and
                other populations. The commenter stated that the available data did not
                provide conclusive evidence that the health disparities were caused by
                discriminatory conduct against LGBT persons and individuals seeking
                abortions, because correlations are not definite evidence of causation.
                The commenter contended that the proposed rule's approach causes
                ambiguity by blurring the distinctions between the two.
                 Response: As an initial matter, the Department wishes to reiterate
                that it will enforce Section 1557 in light of its regulations that
                already protect against disparate impact on the basis of race, color,
                or national origin. With respect to concerns regarding disparate impact
                on LGBT and abortion-seeking populations, the Department notes that
                this final rule conforms the Section 1557 Rule to HHS's Title IX
                regulations, under which the disparate impact standard does not apply.
                This conformity provides a clearer standard for covered entities, which
                are no longer required to have legally sufficient knowledge of the
                causes of statistically disproportionate health disparities on the
                basis of sex or gender identity.
                vii. Insurance Coverage in Sec. 92.207 of the 2016 Rule
                 The 2016 Rule prohibited insurers from ``hav[ing] or implement[ing]
                a categorical coverage exclusion or limitation for all health services
                related to gender transition.'' \217\ Its preamble explained that this
                encompasses a ``range of transition-related services'' to treat gender
                dysphoria that are ``not limited to surgical treatments and may
                include, but [are] not limited to, services such as hormone therapy and
                psychotherapy, which may occur over the lifetime of the individual,''
                and that may be required even if not ``strictly identified as medically
                necessary or appropriate'' insofar as the entity covers other types of
                similarly ``elective'' procedures.\218\
                ---------------------------------------------------------------------------
                 \217\ 81 FR 31472, 31435-36.
                 \218\ Id.
                ---------------------------------------------------------------------------
                 Comment: Commenters indicated support for the 2016 Rule's insurance
                coverage requirements, claiming that the Rule has led to increased
                access to gender transition services for transgender patients, and that
                these services will be lost if the proposed rule is finalized. In
                comments, clinicians provided information about the specific
                procedures, services, or treatments they perform or offer with respect
                to gender identity. Among those who offer medical interventions under
                the category of ``gender transition,'' there was a consensus that such
                interventions included genital sex reassignment surgeries, cross-sex
                hormonal treatment, counseling, and often psychological or psychiatric
                support. Some clinicians stated that only patients with longstanding
                identification as the opposite sex and distress with their biological
                sex sought these services. Beyond these, some (but not all) clinicians
                indicated that gender transition procedures could also include surgery
                for feminization or masculinization of the entire body, which could
                include reduction, augmentation, removal, or transplant of tissue,
                skin, hair, or body fat, as well as ``social transition'' services such
                as voice training.\219\
                ---------------------------------------------------------------------------
                 \219\ Examples of procedures identified were rhinoplasty,
                blepharoplasty, septoplasty, rhytidoplasty, abdominoplasty,
                electrolysis, liposuction, jawline modifications, scalp advancement,
                cheek and chin contouring, fat transfer, pectoral implants, forehead
                or brow lifts, or breast, buttocks, breast, waist, or lip
                augmentation/reduction. See Whitman-Walker Health; Philadelphia
                Transgender Center. HHS-OCR-2019-0007-138335 (Whitman-Walker
                Health). http://www.thetransgendercenter.com/index.php/femaletomale1/ftm-price-list.html; http://www.thetransgendercenter.com/index.php/maletofemale1/mtf-price-list.html.
                ---------------------------------------------------------------------------
                 Some commenters regard transition services (which they said may
                include counseling, hormone therapy, and/or a variety of possible
                surgical treatments) as the governing standard of care. They directed
                the Department to studies on the matter including those cited in the
                2016 Rule preamble, and cited what they said is a consensus of major
                American medical associations \220\ about sex-reassignment surgery,
                cross-sex hormones, and affirmation counseling. Commenters urged the
                Department to follow the 2016 Rule in relying on the standards
                promulgated by the World Professional Association for Transgender
                Health (WPATH).\221\
                ---------------------------------------------------------------------------
                 \220\ Commenters cited Jason Rafferty, ``Ensuring Comprehensive
                Care and Support for Transgender and Gender-Diverse Children and
                Adolescents,'' 142 Pediatrics no. 4 (Oct. 2018) (American Academy of
                Pediatrics policy statement), and noted that the American Medical
                Association, the American College of Physicians, the American
                Psychological Association, the American Psychiatric Association, the
                American Academy of Family Physicians, the Endocrine Society the
                American College of Obstetricians and Gynecologists, and the
                American Academy of Pediatrics, among others, support transition-
                related treatments.
                 \221\ See 81 FR 31429.
                ---------------------------------------------------------------------------
                 Commenters stated that, under the WPATH standards and other
                protocols, treatment for gender dysphoria may require transition-
                related care.\222\ Commenters asserted specific benefits from
                transition-related care in treating gender dysphoria.\223\ For example,
                commenters said that access to transition services leads to decreased
                health disparities, such as lower levels of depression and suicide
                attempts.\224\
                ---------------------------------------------------------------------------
                 \222\ Commenters cited, for example, Wylie C. Hembree et al.,
                Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons:
                An Endocrine Society Clinical Practice Guideline, 102 The Journal of
                Clinical Endocrinology & Metabolism 3869 (2017); Am. Medical Ass'n,
                AMA Policies on GLBT Issues, Patient-Centered Policy H-185.950,
                Removing Financial Barriers to Care for Transgender Patients (2008),
                http://www.imatyfa.org/assets/ama122.pdf; and Am. Psychiatric Ass'n,
                Position Statement on Discrimination Against Transgender and Gender
                Variant Individuals (2012); http://www.dhcs.ca.gov/services/MH/Documents/2013_04_AC_06d_APA_ps2012_Transgen_Disc.pdf (citing WPATH
                Standards); Am. Psychological Ass'n, Policy on Transgender, Gender
                Identity & Gender Expression Non-Discrimination (2008), http://www.apa.org/about/policy/transgender.aspx.
                 \223\ Commenters cited, for example, Ashli A. Owen-Smith, et
                al., Association Between Gender Confirmation Treatments and
                Perceived Gender Congruence, Body Image Satisfaction, and Mental
                Health in a Cohort of Transgender Individuals. J Sexual Medicine
                (Jan. 17, 2018); Gemma L. Witcomb et al., Levels of Depression in
                Transgender People and its Predictors: Results of a Large Matched
                Control Study with Transgender People Accessing Clinical Services,
                J. Affective Disorders (Feb. 2018); and Cecilia Dhejne et al.,
                Mental Health and Gender Dysphoria: A Review of the Literature, 28
                Int'l Rev. Psychiatry 44 (2016).
                 \224\ Commenters cited, for example, Lily Durwood, Katie A.
                McLaughlin, & Kristina R. Olson, Mental Health and Self-Worth in
                Socially Transitioned Transgender Youth, 56 J. Am. Acad. Child
                Adoles. Pyschiatry 116 (2017); Kristina R. Olson et al., Mental
                Health of Transgender Children Who Are Supported in Their
                Identities, 137 Pediatrics (2016); and Stephen T. Russel et al.,
                Chosen Name Use Is Linked to Reduced Depressive Symptoms, Suicidal
                Ideation, and Suicidal Behaviors Among Transgender Youth, 64 J.
                Adolescent Health 503 (2018), https://www.jahonline.org/article/S1054-139X(18)30085-5/fulltext.
                ---------------------------------------------------------------------------
                 With respect to adolescents, some commenters promoted approaches
                that affirm or encourage gender identity variation, including sex
                reassignment, citing data that they said showed it resulted in fewer
                mental health concerns.\225\ Some medical professionals also stated in
                comments that hormone blockers are a safe and reversible way to delay
                puberty, noting
                [[Page 37197]]
                they have been used historically for children experiencing precocious
                puberty, or puberty at a younger age.
                ---------------------------------------------------------------------------
                 \225\ Commenters cited Hill DB, Menvielle E, Sica KM, Johnson A.
                An affirmative intervention for families with gender variant
                children: parental ratings of child mental health and gender. J Sex
                Marital Ther. 36(1):6-23 (2010).
                ---------------------------------------------------------------------------
                 Other commenters disagreed as to whether sex reassignment
                treatments or surgeries, or gender-affirming therapies, are the proper
                care for gender dysphoria, or even whether they are ever medically
                indicated. Instead of surgery, hormones, or cross-sex affirmation
                counseling, some healthcare providers recommended watchful waiting,
                talk therapy that affirms a person's biological sex, or psychological
                or psychiatric treatment of comorbid conditions, as distinct from
                permanent surgical or hormonal interventions.\226\ These providers
                explained that patients with gender dysphoria can work with a
                psychiatrist or counselor to better understand their feelings and
                emotions, and how the incongruence between their psychological identity
                and biological sex causes them distress. Some clinicians stated that
                reinforcing a patient's perception that there is something wrong with
                their body is damaging both to mental and physical health of
                transgender patients.
                ---------------------------------------------------------------------------
                 \226\ Commenters cited sources including Monique Robles,
                ``Observations in a Gender Diversity Clinic,'' 44 Ethics & Medics 2
                (Feb. 2019); and Devita Singh, Ph.D., ``A Follow-up Study of Boys
                with Gender Identity Disorder,'' Department of Human Development and
                Applied Psychology, Ontario Institute for Studies in Education,
                University of Toronto (2012).
                ---------------------------------------------------------------------------
                 Some medical professionals discussed the long-term and irreversible
                physical effects of cross-sex hormones and puberty blockers, pointing
                to permanent deepening of voice, clitoromegaly, jaw enlargement,
                permanent sterility, and sexual dysfunction.\227\ Doctors also
                commented that clinical data have not shown that such hormonal
                treatments improve the long-term psychological functioning of gender
                dysphoric persons. Clinicians stated that certain hormone treatments
                given to persons with gender dysphoria result in glucose and lipid
                metabolism disorders and cardiovascular conditions. Some clinicians
                were critical of the research supporting transition services, stating
                that it does not adequately assess such long-term health consequences
                and ignores a particularly vulnerable population of patients, namely
                the growing population of transitioned individuals who wish to
                transition back but are being ignored or impeded from receiving
                services affirming their biology.\228\ They cited research indicating
                that patients did not need surgical or hormonal transition services
                when less drastic interventions would have been effective.\229\
                Clinicians stated that transition services were burdensome on these
                patients on several levels--financially, physically, and
                psychologically. Commenters concluded that repeal of the 2016 Rule
                would relieve the burden on these transgender individuals by letting
                providers decide, based on their assessment of individuals, what
                surgeries or treatments are appropriate according to their medical
                judgment and without coercive regulatory pressure.
                ---------------------------------------------------------------------------
                 \227\ Commenters cited sources including Talal Alzahrani, M.D.,
                et al., ``Cardiovascular Disease Risk Factors and Myocardial
                Infarction in the Transgender Population,'' Circulation:
                Cardiovascular Quality and Outcomes 12:4 (Apr. 2019), https://www.ncbi.nlm.nih.gov/pubmed/30950651; and Darios Getahun, M.D., et
                al., Cross-sex Hormones and Acute Cardiovascular Events in
                Transgender Persons, Annals of Internal Medicine (July 10, 2018),
                https://www.ncbi.nlm.nih.gov/pubmed/29987313.
                 \228\ Commenters cited, for example, Miroslav L. Djordjevic et
                al., Reversal Surgery in Regretful Male-to-Female Transsexuals After
                Sex Reassignment Surgery, 13 J. of Sexual Med., 1000, 1006 (2016).
                 \229\ Commenters cited, for example, Joe Shute, ``Sex change
                regret: Gender reversal surgery is on the rise, so why aren't we
                talking about it?'' The Telegraph (Oct. 1, 2017), https://www.telegraph.co.uk/health-fitness/body/gender-reversal-surgery-rise-arent-talking.
                ---------------------------------------------------------------------------
                 Some medical providers raised concerns that prescription of sex-
                reassignment procedures and treatments had risked the health of young
                patients under their care due to lack of capacity at young ages to
                fully consent to treatments, difficulties with proper diagnosis during
                changes undergone in adolescence, and the negative impacts on bone mass
                and growth, emotional development, and sexual function.\230\ Some
                clinicians stated that gender dysphoria is not an immutable mental
                health condition and, as such, the appropriate treatment is not
                physical and permanent. Some clinicians stated that current care for
                gender dysphoria includes accommodation counseling, the ``wait and
                see'' approach, and (where indicated) detransition therapy, because
                dysphoria, particularly in children, has a high rates of resolving
                without other interventions. They said that in their medical judgment,
                sex reassignment, cross-sex hormones, and affirming counseling are new
                and controversial treatments with known permanent and negative health
                consequences. Some medical clinicians criticized the WPATH standards
                \231\ for coming to policy conclusions without adequate clinical
                evidence and recommending treatments that are still experimental.\232\
                Other commenters criticized the 2016 Rule for relying on the policy
                recommendations of an international advocacy group to
                [[Page 37198]]
                interpret U.S. nondiscrimination laws and develop policy in the
                American healthcare sector. Other commenters disputed the conclusions
                of medical professional associations referenced above, stating that
                they had mischaracterized the medical data, and that life-altering
                transition interventions are not medically necessary, effective, or
                safe.\233\
                ---------------------------------------------------------------------------
                 \230\ Commenters cited, for example, Lieke Josephina Jeanne
                Johanna Vrouenraets, M.Sc., et al., ``Early Medical Treatment of
                Children and Adolescents With Gender Dysphoria: An Empirical Ethical
                Study,'' Journal of Adolescent Health (Jan. 12, 2015), https://www.ncbi.nlm.nih.gov/pubmed/26119518; and Guido Giovanardi, ``Buying
                time or arresting development? The dilemma of administering hormone
                blockers in trans children and adolescents,'' Porto Biomedical
                Journal (2017).
                 \231\ See Standards of Care for the Health of Transsexual,
                Transgender, and Gender Nonconforming People 16 (7th ed. 2011),
                https://www.wpath.org/publications/soc.
                 \232\ Clinicians stated that the WPATH Standards ignored
                research evidence in support of a ``wait and see'' approach that
                gender dysphoria during childhood has a desistance rate, without
                drastic surgical or medical intervention for sex-reassignment or
                affirmation for social transition. They cited studies including
                Singh, D., ``A Follow Up Study of Boys with Gender Identity
                Disorder,'' doctoral dissertation submitted at University of Toronto
                (2012); Drummond, K. D., Bradley, S. J., Badali-Peterson, M., &
                Zucker, K. J., ``A follow-up study of girls with gender identity
                disorder,'' Developmental Psychology 44:1 (2008), 34-45; Wallien, M.
                S. C., & Cohen-Kettenis, P. T., ``Prediction of adult GID: A follow-
                up study of gender-dysphoric children,'' paper presented at the
                meeting of the World Professional Association of Transgender Health,
                Chicago, IL (2007); and Smith, Y.L., Van Goozen, S.H., & Cohen-
                Kettenis, P. T., ``Adolescents with gender identity disorder who
                were accepted or rejected for sex reassignment surgery: A
                prospective follow-up,'' Journal of the American Academy of Child &
                Adolescent Psychiatry, 40:4 (2001), 472-81.
                 \233\ See Michelle Cretella, ``Gender Dysphoria in Children''
                (November 2018) (American College of Pediatricians policy
                statement); see also James Cantor, ``American Academy of Pediatrics
                Policy and Trans- Kids: Fact-Checking,'' Sexology (Oct. 2018).
                ---------------------------------------------------------------------------
                 Several commenters who expressed objections to the 2016 Rule
                clarified that they do not exclude patients from access to healthcare
                on the basis of the patient's gender identity, but rather objected to
                the rule requiring that they provide treatment that would be
                detrimental to the health and well-being of their patients. Part of
                their medical profession involves recommendations on which treatments
                will appropriately treat medical conditions to improve the health of
                their patients, and the choice not to provide transition surgery or
                abortion is part of those judgments. Some providers indicated that the
                options for treatment they recommend for patients with gender dysphoria
                are therapeutic and accommodative counseling to improve long-term
                health outcomes, particularly of young patients.
                 Other commenters said the Department should rely on the recent
                reviews of the clinical data on sex-reassignment surgery and cross-sex
                hormonal treatment by science and healthcare professionals at HHS and
                DOD.
                 Response: These comments further reinforce the Department's
                conclusion, discussed above in the section on gender identity, that
                there is no medical consensus to support one or another form of
                treatment for gender dysphoria. In the Department's current view, the
                2016 Rule did not give sufficient evidence to justify, as a matter of
                policy, its prohibition on blanket exclusions of coverage for sex-
                reassignment procedures. The Department shares commenters' judgment
                that the 2016 Rule relied excessively on the conclusions of an advocacy
                group (WPATH) rather than on independent scientific fact-finding--such
                as the fact-finding that CMS undertook in deciding to not issue a
                National Coverage Determination with respect to sex-reassignment
                surgeries (as discussed above) due to insufficient proof of medical
                necessity. In addition, commenters identify a lack of clarity in the
                2016 Rule's mandate, because of the lack of medical consensus as to
                what is even encompassed within ``gender transition procedures'' (e.g.,
                whether they include facial reconstruction or hair transplants). All
                these are further reasons why, as a matter of policy, Federal civil
                rights law should not be used to override providers' medical judgments
                regarding treatments for gender dysphoria. But as stated above, even if
                it were appropriate policy, such an end could not be achieved through
                application of Section 1557 and Title IX. There is no statutory
                authority to require the provision or coverage of such procedures under
                Title IX protections from discrimination on the basis of sex.
                 Comment: Some commenters state that the provisions in Sec.
                92.207(b)(3) through (5) of the 2016 Rule were confusing, overbroad,
                unclear, and inconsistent. Commenters stated that specificity in this
                area is necessary for efficient and transparent operation of the health
                insurance coverage to work for all involved. Commenters expressed
                concerns that the 2016 Rule did not address whether insurers are
                required to pay for all such surgeries, including without prior
                approval; approve them absent some standard of medical necessity; or
                approve them even over concerns of later malpractice lawsuits by the
                patient. A commenter reiterated his comments on the 2015 NPRM that the
                2016 Rule's requirements related to gender transition were confusing
                for covered entities. The commenter said the regulatory requirement did
                not address which healthcare providers must provide these surgeries:
                e.g., plastic surgeons, thoracic surgeons, general surgeons, or
                physicians whether or not they ordinarily perform major surgery. Others
                stated that although the 2016 Rule preamble characterized the
                categorical exclusion provision as a ``limited'' exception, the
                provisions on gender transition-related services were very broad and
                could include facial feminization or masculinization surgeries. Some
                commenters interpreted ``gender dysphoria'' as only affecting
                transgender individuals who seek sex re-assignment services, but other
                commenters cited clinical data indicating that men who had genital
                combat injuries and women who had removal of cancerous tissue in
                breasts and have received the diagnosis may also experience body
                dysmorphia.\234\
                ---------------------------------------------------------------------------
                 \234\ Commenters cited M. Jocelyn Elders, et al., ``Medical
                Aspects of Transgender Military Service,'' Armed Forces and Society
                41(2) (Mar. 2014): 199-220.
                ---------------------------------------------------------------------------
                 Other commenters stated that surgical sex reassignment (which may
                also include cross-sex hormonal treatment) may cost up to $22,025 on
                average for those covered by insurers. Still others said that the
                definition of ``gender dysphoria'' itself has changed rapidly and
                unpredictably over the years, leading to confusion, and point to its
                shifting conception as an experience of distress or a personal
                characteristic, to different and changing terms used for diagnosis of
                gender dysphoria in the DSM, and to the varied use of both clinical
                medical terms and sociological identity terms concerning the topic. The
                American Psychiatric Association justified the abandonment of the term
                ``gender identity disorder'' and its replacement with ``gender
                dysphoria'' in the Diagnostic and Statistical Manual of Mental
                Disorders to reduce stigmatization of the particular mental condition,
                but commenters noted that the DSM-5 made no changes to remove the
                classification of ``disorder'' for suicidal ideation, other body
                dysmorphias, or substance use disorder, which mental health advocates
                commented are also stigmatizing and may be comorbid with gender
                dysphoria.
                 Response: The Department agrees that the 2016 Rule made confusing
                and overbroad demands on covered entities, including insurance
                providers, and left unclear to what extent it was requiring providers
                to provide, or health insurance issuers to cover, treatments such as
                facial feminization, Adam's apple reduction, and hair transplants as
                part of ``health services related to gender transition.'' This final
                rule seeks to handle issues involving the exercise of legitimate
                medical judgment (including determinations relating to medical
                necessity and coverage decisions) with greater care, and to provide
                covered entities with greater clarity regarding their regulatory
                obligations.
                 Comment: Some commenters who identified as transgender patients
                opposed the proposed rule on the grounds that they had budgeted and
                planned with the expectation that there would be a limited or no cost
                for transition services due to the 2016 Rule, but they were surprised
                when they had an out-of-pocket cost not covered by their selected
                insurance company or plan. A much higher cost for these services
                resulted in the inability to receive or delay in receiving such
                services. They described surprise billing at multiple steps of the
                process, from reviewing health insurance coverage plans to waiting for
                reimbursements. These commenters stated that they anticipated and
                relied on OCR's 2016
                [[Page 37199]]
                Rule as guaranteeing them insurance coverage because it is provided to
                other patients, and that this was their understanding of the Affordable
                Care Act and their civil rights protections. Other commenters contended
                that the 2016 Rule had caused the reduction of blanket exclusions for
                gender transition in health insurance coverage over the past three
                years.\235\ Others stated that short-term limited duration insurance
                plans do not provide coverage of gender transition-related services,
                and therefore if transgender individuals are covered by such plans,
                they would not be able afford medically necessary services.
                ---------------------------------------------------------------------------
                 \235\ Commenters cited sources including, e.g., Out2Enroll,
                Summary of Findings: 2019 Marketplace Plan Compliance with Section
                1557 (finding that 18.5% of insurers in 2017, 28% of insurers in
                2018, and 94% of the insurers did not include blanket exclusions in
                their plans).
                ---------------------------------------------------------------------------
                 Response: With respect to coverage for gender transition services,
                the Department notes that this final rule makes no changes to what has
                been the status quo since December 2016, when the Department was
                enjoined from enforcement of the gender identity provisions of the 2016
                Rule; such provisions have now been vacated by a court. Any recent
                decrease in blanket exclusions for sex-reassignment coverage is
                therefore more likely to be attributable to health insurance issuer or
                plan sponsor choice. State-level legal requirements concerning gender
                identity coverage have also come into effect in recent years, such as
                State statutes, regulations, guidance,\236\ and court orders \237\--
                this final rule does not affect those changes in any way. But to the
                extent that provisions in the 2016 Rule did pressure any insurers to
                cover services on the basis of gender identity that they previously had
                not covered, such provisions did so without statutory authority, which
                is why they were preliminarily enjoined and vacated.
                ---------------------------------------------------------------------------
                 \236\ See, e.g., Calif. Health and Safety Code 1365.5; Colo.
                Insurance Bulletin No. B-3.49; Conn. Insurance Bulletin IC-34; 79
                Del. Laws Ch. 47; DC Code 31-2231.11; Haw. Rev. Stat. 431:10A-118.3,
                432:1-607.3, 432D-26.3; 50 Ill. Adm. Code 2603.35; Mass. Insurance
                Bulletin 2014-03; Nev. Rev. Stat. 651.070; Nev. Admin. Code
                686A.140(7); 11 New York Codes Rules and Regulations 52.16; New York
                Insurance Code 2607, 3243, 4330; Ore. Rev. Stat. 746.015; Ore.
                Admin. Rules 836-080-0055; 46 Pa. Bulletin 2251; Rhode Island Health
                Insurance Bulletin 2015-3; 8 Va. Stat. Ann. 4724; Vt. Insurance
                Bulletin 174; Wash. Rev. Code 48.30.300.
                 \237\ See, e.g., Outfront v. Piper, No. 62-cv-15-7501 (Minn. D.
                Ct. Nov. 14, 2016) (interpreting the state Constitution as applied
                to MinnesotaCare); Good v. Iowa Dept. of Human Services, No. 18-1158
                (Iowa S. Ct. Mar. 8, 2019) (interpreting the Iowa Civil Rights Act
                as applied medical assistance).
                ---------------------------------------------------------------------------
                 As a policy matter, the Department recognizes that surprise billing
                is a serious problem, but that topic is not a subject of this
                rulemaking. As for short-term limited duration insurance, for reasons
                discussed below, it is generally not regulated under this final rule
                and so is generally not affected by the rule's nondiscrimination
                requirements in any case.
                e. Discrimination on the Basis of Association, Repeal of Sec. 92.209
                of the 2016 Rule
                 The Department proposed to repeal Sec. 92.209 of the 2016 Rule,
                which included a prohibition on discrimination against an individual or
                entity on the basis of being known to or believed to have a
                relationship or association.
                 Comment: Commenters opposed the repeal of prohibitions against
                discrimination based on association with a protected category. These
                commenters contended that removing such protections would cause
                confusion, both for covered entities who will be unsure of their
                responsibilities and for individuals who will be unsure of their
                rights, especially in light of other Federal nondiscrimination laws
                that the Department enforces. For example, the Department enforces
                Title II of the ADA and its implementing regulation, which prohibits
                discrimination against an individual based on his or her association
                with another individual with a disability, as do Titles I and III of
                the ADA.\238\ Commenters said that this also shows that it would defy
                Congressional intent, and cause inconsistency among different
                regulations that covered entities are subject to, if the Department
                were to withdraw associational discrimination protections from patients
                seeking healthcare. Commenters also expressed concern that the proposed
                rule would make it more difficult for those experiencing discrimination
                by association to enforce their rights. Other commenters stated that
                the lack of reference to associational discrimination in the proposed
                rule is inconsistent with existing case law that validates prohibitions
                on associational discrimination, particularly in employment
                discrimination cases brought under Title VII pertaining to race, sex,
                and religion. Others argued that it is incorrect to assume that by
                referencing the grounds protected under previous civil rights laws,
                Section 1557 automatically incorporates the limitations found in those
                laws.
                ---------------------------------------------------------------------------
                 \238\ 28 CFR 35.130(g) (Title II); 42 U.S.C. 12112(b)(4) (Title
                I); 42 U.S.C. 12182(b)(1)(E) (Title III).
                ---------------------------------------------------------------------------
                 Some commenters contended that specific protected populations are
                more susceptible to associational discrimination. In particular,
                commenters stated that deaf and hard-of-hearing patients frequently use
                hearing companions, especially in hospital settings, and may be subject
                to associational discrimination. Commenters also identified potential
                instances of associational discrimination, including an entity's
                refusing to provide medical services to a white individual due to
                association with an African American individual, refusing to provide
                medical services to a child because his parents speak a different
                language, or refusing to provide services to an individual because her
                family members have a specific disability.
                 Response: This final rule neither abrogates nor withdraws any
                protections available under the incorporated civil rights statutes or
                their implementing regulations. It simply declines to use the Section
                1557 regulation to identify protections beyond those specifically
                identified in the text of the relevant statutes and regulations.
                Protections against discrimination on the basis of association will be
                available under this final rule to the extent that they are available
                under those statutes and regulations. As stated above, the Department
                regards this as the best way to decrease confusion. As the Franciscan
                Alliance court noted, the executive branch is obligated to implement
                Section 1557, with the civil rights statutes it incorporates, by
                ``giving the statutory text its plain and ordinary meaning, construing
                the statute as a whole, and giving effect to every word of the
                statute.'' \239\ Courts have held that Section 1557 incorporates the
                limitations of the civil rights statutes referenced in Section
                1557.\240\
                ---------------------------------------------------------------------------
                 \239\ Franciscan Alliance, Inc. v. Burwell, 227 F. Supp. 3d 660,
                690 (N.D. Tex. 2016).
                 \240\ See, e.g., Condry v. UnitedHealth Group, 2018 WL 3203046
                (N.D. Cal. Jun 27, 2018) (``disparate impact claims on the basis of
                sex are not cognizable under section 1557'').
                ---------------------------------------------------------------------------
                 Some instances discussed by commenters would appear to constitute
                discrimination against a person under the underlying civil rights
                statutes even without the 2016 Rule's prohibition on associational
                discrimination. For example, if a covered entity refused to provide
                meaningful access for LEP parents who are legally entitled to make
                medical decisions on behalf of their child, it could constitute
                discrimination on the basis of national origin.
                f. Multiple Protected Statuses
                 The Department received many comments about individuals who may
                have protected status or face discrimination on multiple grounds.
                [[Page 37200]]
                 Comment: One commenter stated that because the 2016 Rule covers
                discrimination based on multiple protected statuses, the proposed rule
                would create a confusing mix of legal standards and available remedies
                and therefore could limit claims of intentional discrimination, while
                the 2016 Rule makes it easier for members of the public to file
                complaints of intersectional discrimination in one place.
                 Response: OCR has long accepted complaints alleging discrimination
                based on more than one protected status. OCR has handled those
                complaints, and will continue to handle them, under the implementing
                regulations of each of its applicable civil rights laws. Nothing in
                this final rule changes that. OCR's complaint form provides the public
                with the option to select multiple forms of prohibited discriminatory
                practices, such as both race and disability. OCR continues to encourage
                the public to file complaints about potentially unlawful
                discrimination, whether on one prohibited basis or on multiple
                prohibited bases.
                 Comment: Commenters stated that the proposed rule would compound
                discrimination faced by individuals with multiple protected
                characteristics, such as people of color who are also LEP or disabled.
                Some commenters said that African Americans are more likely to live
                with disabilities and chronic conditions, and thus would be
                disproportionately affected by relaxing discrimination restrictions for
                health insurance plans.
                 Response: The Department commits itself, in this final rule, to
                fully enforce Section 1557 according to its text and the text of the
                underlying statutes, as well as under the Department's implementing
                regulations for those statutes, as applied to the health context.
                Although the Department is proposing to repeal the nondiscrimination
                provision of the 2016 Rule at Sec. 92.101, this final rule replaces it
                with a general provisions section at Sec. 92.2. The new section will
                maintain the nondiscrimination requirements required by Title VI, Title
                IX, the Age Act, and Section 504. As such, individuals with multiple
                protected characteristics, such as race and disability, would be
                protected under the Department's enforcement of Section 1557 to the
                extent those statutes and regulations apply. Those statutes and
                regulations explain which characteristics are protected.
                 With respect to LEP and disability, this final rule additionally
                contains specific sections clarifying those protections. The underlying
                regulations and guidance for enforcing these statutes establish
                standards that are well-known by covered entities. The Department will
                continue to robustly enforce these statutes, and believes this final
                rule provides appropriate language to ensure that enforcement occurs.
                 Comment: Commenters contend that African American, Asian American
                and Pacific Islander, and Native American women are more likely to die
                from pregnancy-related complications and will be disproportionately
                affected by changes to the interpretation of sex discrimination in the
                proposed rule. Others contend that LGBT people of color will be harmed
                by the proposed regulation; they also state that LGBT people of
                specific national origins, including Native American and Middle
                Eastern, experience high rates of negative experiences in healthcare
                settings related to gender identity. Commenters alleged the proposed
                rule would disproportionately harm Native American women, women of
                color, and transgender individuals who are minorities.
                 Response: As discussed above, the 2016 Rule's definition of ``on
                the basis of sex'' is not included in this final rule because it
                exceeded the Department's statutory authority. In addition, with
                respect to gender identity and termination of pregnancy, the court's
                longstanding preliminary injunction and eventual vacatur of that
                language means that the results some commenters fear from removing such
                language would not be the result of this final rule. The Department is
                not aware of data supporting commenters' assertion that this change
                will have a disparate impact on the basis of race or national origin,
                although even if it did, that disparate impact would be attributable to
                the statutes rather than to this final rule. To the extent that the
                Department learns that individuals suffer barriers to healthcare on the
                basis of race, national origin, or any other protected characteristic,
                it will work to address those barriers within the limits of its
                statutory authority.
                g. Examples of Discriminatory Practices (Repeal of Sec. 92.207 of the
                2016 Rule)
                 The Department proposed to repeal Sec. 92.207 of the 2016 Rule,
                which stipulated that covered entities must not discriminate on the
                prohibited bases in providing or administering health-related insurance
                or other health-related coverage, and listed examples of such
                prohibited discrimination. Comments pertaining to Sec. 92.207(b)(3)-
                (5) related to gender identity are discussed above in the section on
                discrimination on the basis of sex.
                 Comment: Commenters opposed repealing the explicit provisions of
                Sec. 92.207 that prohibit covered entities from discriminating in
                health insurance or other health coverage. Commenters argued that the
                proposed rule did not provide any reasoned legal or policy basis for
                the repeal, which precluded the opportunity to provide public comment
                on the Department's justifications and so violated the APA. While the
                proposed rule discussed repealing provisions that may be duplicative,
                inconsistent, or confusing, commenters argued that the Department did
                not explain under which of these grounds it was repealing Sec. 92.207,
                and that the proposed rule's supporting footnote \241\ listed
                comparator regulatory citations that did not duplicate or contradict
                the provisions of Sec. 92.207.
                ---------------------------------------------------------------------------
                 \241\ 84 FR at 27869 n.147 (comparing 45 CFR 92.207 with ``45
                CFR 80.5 (health benefits under Title VI), 84.43 (health insurance
                under Section 504), 84.52 (health benefits under Section 504), 84.33
                (rule of construction of Section 504 vis-[agrave]-vis validly
                obligated payments from health insurer); 86.39 (health insurance
                benefits and services under Title IX).'').
                ---------------------------------------------------------------------------
                 Commenters also expressed concern that repealing this section would
                allow health insurance issuers to discriminate, particularly with
                regard to benefit design, and could make it harder for people who
                experience discrimination to enforce their rights through
                administrative and judicial complaints. Commenters asserted that, prior
                to the ACA, health insurance issuers avoided covering costly
                individuals by employing the discriminatory practices prohibited by
                Sec. 92.207, and that repealing these explicit prohibitions would
                allow health insurance issuers to again discriminate in a variety of
                ways, including by excluding or denying benefits, applying age limits,
                increasing costs for sicker enrollees, imposing utilization management
                limitations, and designing discriminatory prescription drug
                formularies. Commenters also argued that the ACA was intended to
                increase administrative oversight of private health insurance plans and
                to prevent discrimination in health insurance, particularly in light of
                the underlying civil rights laws' historically limited application to
                private health insurance and benefit design prior to the ACA.
                 Several commenters argued that the removal of specific
                nondiscrimination provisions under Sec. 92.207 would make the
                regulation vague, eliminate guidance for covered entities, and create
                confusion about what is prohibited conduct, thereby increasing legal
                [[Page 37201]]
                uncertainty and risk. This argument was reiterated by some State
                government regulators, who said that the specificity in the law
                provides clarity for both covered entities and the State, with State
                regulators often relying upon the standards in the 2016 Rule to ensure
                nondiscrimination in health insurance. Other commenters said that the
                repeal of Sec. 92.207, compounded with the repeal of language access
                and taglines requirements, would open the door to discrimination based
                on national origin by healthcare providers.
                 Response: The number, breadth, and depth of comments received and
                discussed in this preamble indicate that the public was given an
                adequate opportunity to provide comment on the Department's
                justifications for this final rule.
                 Commenters are correct to note that the ACA has significantly
                expanded the applicability of Federal civil rights laws to private
                health insurance plans. That is why, under this final rule, all health
                insurance programs that remain covered by Section 1557 remain
                prohibited from discriminating on the grounds specified by the statute.
                This final rule has a section on scope at Sec. 92.3, and the
                Department does not believe the rule needs an additional or separate
                section on health insurance in order to make this clear. OCR will
                examine carefully any allegations of discrimination by health insurance
                issuers, including through benefit design, and will vigorously enforce
                Section 1557's prohibitions. The Department also notes that certain
                health insurance issuers remain subject to similar nondiscrimination
                requirements under statutory provisions implemented and the regulations
                issued by CMS's Center for Consumer Information and Insurance Oversight
                (CCIIO). Commenters' specific concerns about national origin
                discrimination are addressed above and below in the relevant sections.
                 The 2019 NPRM listed Sec. 92.207 among passages of the 2016 Rule
                that ``are duplicative of, inconsistent with, or may be confusing in
                relation to the Department's preexisting Title VI, Section 504, Title
                IX, and the Age Act regulations.'' \242\ As the footnote referenced by
                commenters shows, the Department specifically pointed there to
                preexisting HHS regulations under those statutes regarding health
                benefits and health insurance.\243\ The substantive overlap between
                these regulations and Sec. 92.207 is sufficient to show that the
                latter either duplicates them, or is inconsistent with them, or may be
                confusing as to whether it is duplicating them or contradicting them.
                Because Section 1557 does not require a regulation, the Department
                prefers to enforce the relevant statutes, to the extent possible,
                through their existing regulations. The changes in the 1557 regulation
                made by this final rule advance the Administration's goal of reducing
                the regulatory burden of the ACA and of administrative action in
                general.\244\
                ---------------------------------------------------------------------------
                 \242\ 84 FR 27869.
                 \243\ See 84 FR at 27869 n.147.
                 \244\ Executive Order 13765 on Minimizing the Economic Burden of
                the Patient Protection and Affordable Care Act Pending Repeal, 82 FR
                8351 (Jan. 20, 2017); Executive Order 13771 on Reducing Regulation
                and Controlling Costs (Jan. 30, 2017); Executive Order 13777 on
                Enforcing the Regulatory Reform Agenda (Feb. 24, 2017); Executive
                Order 12866 on Regulatory Planning and Review, 58 FR 190 (Oct. 4,
                1993), at Sec. 1(b)(10).
                ---------------------------------------------------------------------------
                 The 2016 Rule's list of examples of prohibited conduct by insurers
                at Sec. 92.207(b) was followed by a catchall provision at Sec.
                92.207(c) stipulating that the enumeration of those specific forms of
                discrimination was no limitation on the general prohibition on
                insurers' discriminating on the prohibited grounds. That catchall
                provision made Sec. 92.207 no less vague, and gave it no less
                potential to cause confusion, than this final rule's general
                prohibition on discrimination by covered entities. The Department
                declines in this preamble to give guidance of this kind to State
                regulators, who must each work within their own State's regulatory
                framework for health insurance. The Department notes that State
                regulators may also rely upon regulations issued by CCIIO, as
                applicable.
                h. Summary of Regulatory Changes
                 For the reasons discussed herein, and considering the comments
                received, the Department finalizes its proposed new Sec. 92.2 without
                change, its repeal of Sec. 92.4 without change, its repeal of the
                notice requirement in Sec. 92.8(d) and Appendix B without change, and
                its repeal of Sec. 92.101, 92.206-92.207, and 92.209 without change.
                (5) Assurances in Proposed Sec. 92.4, and Repeal of Sec. 92.5 of the
                2016 Rule
                 The Department proposed that the 2016 Rule's provision at Sec.
                92.3 requiring an assurance of compliance with Section 1557 be retained
                and redesignated Sec. 92.4. 84 FR at 27863. Here, as throughout the
                proposed rule, the Department also updated the 2016 Rule's term
                ``State-based Marketplace\SM\'' to read ``State Exchange,'' in
                conformity with current CMS regulations. 84 FR at 27871.
                 Comment: Comments contended it is unclear whether submitting
                assurances required under this provision at Sec. 92.4 would also
                fulfill the assurance requirements of Section 504 at 45 CFR 84.5.
                 Response: As under the 2016 Rule, the application package for all
                HHS grant-making agencies continues to include a requirement that the
                applying entity submit a signed assurance form (Form 690), which
                specifically references Section 1557 along with Title VI, Title IX,
                Section 504, and the Age Act. That form is available at https://www.hhs.gov/sites/default/files/forms/hhs-690.pdf. All recipients of
                Federal financial assistance from HHS are required to submit the
                consolidated form that satisfies the assurance requirements for both
                Section 1557 and these four other civil rights statutes.
                 The Department requested comment on whether this proposal struck
                the proper balance by retaining the assurance provisions from the 2016
                Rule, and whether the benefits of these provisions exceed the burdens
                imposed by them.
                 Comment: Some commenters expressed their support for maintaining
                the current assurance of compliance requirement, noting that an
                assurance of compliance is an important step towards ensuring that
                covered entities know their obligations under Section 1557 and remain
                compliant. Additionally, questions were raised regarding which entity
                would be responsible for oversight, enforcement, and corrective action
                should a covered entity violate Section 1557 despite assuring its
                compliance.
                 Response: OCR is responsible for enforcing Section 1557 and will
                provide oversight, enforcement, and corrective action should a covered
                entity violate its obligations under Section 1557. The Department
                agrees that assurances of compliance provide valuable services by
                alerting covered entities of their obligations, and will retain these
                provisions under Sec. 92.4 of this final rule.
                 Summary of Regulatory Changes: For the reasons given in the
                proposed rule, and having considered comments received, the Department
                finalizes its proposed Sec. 92.4, and repeal of Sec. 92.5 of the 2016
                Rule, without change.
                (6) Enforcement Mechanisms in Proposed Sec. 92.5, and Repeal of
                Sec. Sec. 92.6, 92.7, 92.8, 92.101, 92.301, 92.302, 92.303, and
                Appendices A and C of the 2016 Rule
                 The Department proposed provisions on enforcement of Section 1557
                at the new Sec. 92.5, 84 FR at 27863, and proposed to repeal
                Sec. Sec. 92.6, 92.7, 92.8, 92.101, 92.301, 92.302, 92.303, and
                [[Page 37202]]
                Appendices A and C of the 2016 Rule, which also provided for
                enforcement mechanisms and notices.
                a. Enforcement Procedures and Underlying Regulations in Sec. 92.5(a)
                (Repeal of Sec. 92.302 and Sec. 92.6(a) of the 2016 Rule)
                 Proposed Sec. 92.5(a) applies the enforcement mechanisms provided
                for, and available under, Title VI of the Civil Rights Act of 1964,
                Title IX of the Education Amendments of 1972, the Age Discrimination
                Act of 1975, or Section 504 of the Rehabilitation Act of 1973, with
                their respective implementing regulations, to Section 1557.
                 Comment: Various commenters expressed opposition to the
                Department's proposal to replace Sec. 92.301 with Sec. 92.5, and
                requested that the Department retain Sec. 92.301. Others expressed the
                view that by adopting Sec. 92.5, the Department would be incorrectly
                limiting the remedies available under Section 1557. Several commenters
                asserted that enforcement would be more difficult under the proposed
                rule because, they said, it creates a patchwork of legal standards--
                unlike the 2016 Rule, which used a single standard that permitted
                disparate impact claims. They said this would create confusion, hamper
                enforcement, and dilute the protections provided to individuals.
                 Response: This final rule properly limits the remedies available
                under Section 1557. The text of the 2016 Rule, at Sec. 92.301(a),
                stated that the enforcement mechanisms available and provided for under
                Title VI, Title IX, Section 504 and the Age Act shall apply for the
                purposes of Section 1557.\245\ But upon reconsideration of these
                issues, the Department concludes the 2016 Rule applied these mechanisms
                in a confusing and inconsistent manner. For certain covered entities,
                it applied Title VI mechanisms, not only to grounds of discrimination
                prohibited under Title VI, but also to those prohibited under Title IX
                and Section 504, while leaving Age Act mechanisms in place for the
                grounds of discrimination it prohibits; for other covered entities, it
                applied Section 504 mechanisms, not only to grounds of discrimination
                prohibited under Section 504, but also to those prohibited under Title
                VI, Title IX, and the Age Act.\246\ The 2016 Rule's regulatory
                structure blended new standards and preexisting standards from
                underlying civil rights regulations, and imposed those standards
                alongside the underlying regulations, which were left in place. In
                contrast, this final rule adopts the enforcement mechanisms for these
                four statutes and their implementing regulations respectively, each for
                its own statute. The Department believes this minimizes the patchwork
                effect of the 2016 Rule by using a familiar regulatory regime under
                those four statutes. The Department also believes this approach is what
                the statutory text contemplates. Moreover, because OCR has significant
                experience enforcing civil rights claims using these civil rights
                statutes' regulations, the Department expects this change to improve
                enforcement of Section 1557 and, by removing possible confusion, to
                make it easier for both individuals and covered entities to know their
                rights and responsibilities.
                ---------------------------------------------------------------------------
                 \245\ 81 FR 31472.
                 \246\ Id.
                ---------------------------------------------------------------------------
                 Comment: One commenter said that the Department's proposal to
                remove the 2016 Rule's single standard for enforcing claims is
                inconsistent with the Minnesota District Court's finding in Rumble v.
                Fairview Health Services that ``Congress intended to create a new,
                health-specific, anti-discrimination cause of action that is subject to
                a singular standard, regardless of a plaintiff's protected class
                status.'' \247\
                ---------------------------------------------------------------------------
                 \247\ 2015 WL 1197415, at *11 (D. Minn. Mar. 16, 2015).
                ---------------------------------------------------------------------------
                 Response: The Department disagrees with this commenter's suggestion
                that it is inappropriate to finalize the proposed rule's repeal of
                provisions containing certain enforcement mechanisms. The Minnesota
                District Court found the language of the Section 1557 statute to be
                ``ambiguous, insofar as each of the four statutes utilize[s] different
                standards for determining liability, causation, and a plaintiff's
                burden of proof,'' \248\ and concluded that the Department's
                interpretation of Section 1557 was permissible. However, the Minnesota
                District Court view is the minority view and has subsequently been
                rejected by multiple other court rulings that postdate the 2016
                Rule.\249\ The Department agrees with these latter courts' reasoning.
                To the extent that the statutory language could be ambiguous, as the
                Minnesota district court concluded, the Department believes that its
                new interpretation is a better and reasonable interpretation of the
                statute, and is at least an equally permissible statutory
                interpretation, and therefore is entitled to Chevron deference, Chevron
                U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984). That the Department's
                interpretation represents a break with a previous interpretation does
                not preclude the Department from reinterpreting the statute and
                receiving Chevron deference for its new interpretation, see, e.g., Rust
                v. Sullivan, 500 U.S. 173, 186-87 (1991). Here, the Department believes
                that this final rule's approach is the one best suited to reducing
                confusion and robustly enforcing Section 1557's nondiscrimination
                provisions.
                ---------------------------------------------------------------------------
                 \248\ Id. at *10.
                 \249\ See Briscoe v. Health Care Svc. Corp., 281 F. Supp. 3d
                725, 738 (N.D. Ill. 2017) (``Taken together, the first two sentences
                of Sec. 1557 unambiguously demonstrate Congress's intent `to import
                the various different standards and burdens of proof into a Section
                1557 claim, depending upon the protected class at issue.'''),
                quoting Southeastern Pennsylvania Transp. Auth. v. Gilead Sciences
                Inc., 698-99 (E.D. Pa. 2015); York v. Wellmark, Inc., 2017 WL
                11261026, at *18 (S.D. Iowa Sept. 6, 2017) (``Congress clearly
                intended to incorporate the statutes' specific enforcement
                mechanisms rather than create a general catch-all standard
                applicable to all discrimination claims.''). See also Galuten on
                Behalf of Estate of Galuten v. Williamson Med. Ctr., 2019 WL
                1546940, at *5. (M.D. Tenn. Apr. 9, 2019) (same); E.S. by and
                through R.S. v. Regence BlueShield, 2018 WL 4566053, at *4 (W.D.
                Wash. Sept. 24, 2018); Doe v. BlueCross BlueShield of Tennessee,
                Inc., 2018 WL 3625012, at *6 (W.D. Tenn. July 30, 2018).
                ---------------------------------------------------------------------------
                b. Compensatory Damages (Repeal of Sec. 92.301(b) of the 2016 Rule)
                 The Department proposed to repeal Sec. 92.301(b) of the 2016 Rule,
                which provided for compensatory damages for any and all claims under
                Section 1557.
                 Comment: Some commenters opposed the changes to the enforcement
                mechanisms under the proposed rule and asserted that Section 1557 makes
                available to all individuals any of the enforcement mechanisms
                available under any of the four civil rights statutes, including but
                not limited to compensatory damages.
                 Response: Although the 2016 Rule stated that compensatory damages
                are available in appropriate administrative and judicial actions under
                the Section 1557 regulation, the Department has concluded that its
                enforcement of Section 1557 should conform to the Department of
                Justice's Title VI Manual. 84 FR at 27851. The manual states that,
                under applicable Federal case law, compensatory damages are generally
                unavailable for claims based solely on a Federal agency's disparate
                impact regulations.\250\ Consequently, the Department considers it most
                appropriate to finalize this rule by eliminating Sec. 92.301(b) and
                reverting to enforcement under the regulations applicable to Title VI,
                Title IX, the Age Act, or Section 504. To the extent compensatory
                damages are, or are not,
                [[Page 37203]]
                available under those regulations, the regulations will provide for
                enforcement of Section 1557 in applicable circumstances in the same
                way.
                ---------------------------------------------------------------------------
                 \250\ See DOJ Title VI Manual, https://www.justice.gov/crt/fcs/T6Manual9 (citing Alexander v. Sandoval, 532 U.S. 275, 282-83
                (2001), Barnes v. Gorman, 536 U.S. 181, 187 (2002), and Gebser v.
                Lago Vista Indep. Sch., 524 U.S. 274, 87 (1998)).
                ---------------------------------------------------------------------------
                 This approach is consistent with both the best interpretation of
                the text and the court decisions (cited above) indicating that Section
                1557 does not impose a single standard but instead incorporates the
                distinct enforcement mechanisms of each of the four civil rights
                statutes described in Section 1557.\251\
                ---------------------------------------------------------------------------
                 \251\ See Galuten, 2019 WL 1546940, at *5 n.8 (because ``the Age
                Discrimination Act would not authorize [ ] compensatory damages,''
                ``it appears that a Federal court with jurisdiction would be
                constrained to dismiss Plaintiff's claims for compensatory . . .
                damages under the ACA'').
                ---------------------------------------------------------------------------
                c. Implied Private Rights of Action (Repeal of Sec. 92.302(d) of the
                2016 Rule)
                 The Department proposed to repeal Sec. 92.302(d) of the 2016 Rule,
                which stated that an individual or entity may bring a civil action in a
                United States District Court to challenge a violation of Section 1557
                or the 2016 Rule.
                 Comment: Some commenters opposed repeal of this language. Several
                commenters argued that the existence of a private right of action is
                clear from the statutory language in Section 1557, which they say
                explicitly references and incorporates the enforcement mechanisms of
                the four civil rights laws listed, including a private right of action.
                They cited cases that allow for Section 1557 to include enforcement
                mechanisms separate from the mechanisms in underlying statutes.\252\
                Commenters said that the creation of a private right of action within
                Section 1557 is consistent with Congress's intent that civil rights
                laws be broadly interpreted to effectuate the remedial purposes of
                those laws, and that removing Section 1557's private right of action is
                inconsistent with precedent of the United States Supreme Court, which
                has upheld private rights of action under the preexisting civil rights
                laws.
                ---------------------------------------------------------------------------
                 \252\ Commenters cited Edmo v. Idaho Dep't of Corr., No. 1:17-
                cv-00151-BLW, 2018 WL 2745898, at *9 (D. Idaho June 7, 2018)
                (``[C]ross-referencing the statutes and the express incorporation of
                the enforcement mechanisms from those statutes is probative of
                Congressional intent to provide both a private right and a private
                remedy for violations of Section 1557.''); Esparza v. Univ. Med.
                Ctr. Mgmt. Corp., No. 17-4803, 2017 WL 4791185, at *5 (E.D. La. Oct.
                24, 2017) (concluding it was ``abundantly clear to the Court that
                Congress intended to create a private right of action to enforce
                Sec. 1557''); Doe One v. CVS Pharmacy, Inc., 348 F. Supp. 3d 967,
                982 (N.D. Cal. 2018) (finding plaintiffs had not sufficiently
                alleged disparate impact); see also Cannon v. Univ. of Chi., 441
                U.S. 677, 703 (1979) (recognizing that Congress intended to create
                Title IX remedies comparable to those available under Title VI,
                including a private cause of action for victims of the prohibited
                discrimination, and finding that age and advanced degrees criteria
                had a disparate impact on women); Rumble v. Fairview Health Servs.,
                2015 WL 1197415.
                ---------------------------------------------------------------------------
                 Response: Upon reconsideration of this issue, the Department no
                longer intends to take a position in its regulations on the issue of
                whether Section 1557 provides a private right of action. To the extent
                that Section 1557 permits private rights of action, plaintiffs can
                assert claims under Section 1557 itself rather than under the
                Department's Section 1557 regulation.
                 Comment: Commenters requested that the Department adopt a
                regulatory framework for Section 1557 where there is a requirement for
                exhaustion of administrative remedies before a party can bring a
                private right of action.
                 Response: Because the Department is eliminating the language
                specifying a right to sue, the Department does not consider it
                necessary to establish a framework and a requirement for exhaustion of
                administrative remedies before filing suit in court.
                d. Voluntary Action (Repeal of Sec. 92.302(c) and Sec. 92.6(b) of the
                2016 Rule)
                 The Department proposed to repeal Sec. 92.302(c) of the 2016 Rule,
                as well as Sec. 92.6(b), which set forth provisions concerning
                voluntary cooperation with requests for information, and voluntary
                action beyond the requirements of Section 1557. These provisions have
                parallels in the regulations implementing Title VI, Section 504, Title
                IX, and the Age Act,\253\ which the Department will use to enforce
                Section 1557.
                ---------------------------------------------------------------------------
                 \253\ See 45 CFR 80.7(d), Sec. 80.8(c)(1) (Title VI); Sec.
                84.6(b) (Section 504); proposed Sec. 86.71 (Title IX incorporating
                45 CFR 80.7(d)); Sec. 90.49(c) (Age).
                ---------------------------------------------------------------------------
                 The Department did not receive comments specific to these sections.
                e. Access to Records of Compliance (Repeal of Sec. 92.303(c) of the
                2016 Rule)
                 The Department proposed to repeal Sec. 92.303(c) of the 2016 Rule,
                which set forth the Department's obligations to permit access by OCR to
                review records and sources of information, and to otherwise comply with
                OCR investigations under the 2016 Rule.
                 Comment: Commenters expressed concern that the proposed rule
                undermines the Department's enforcement authority concerning compliance
                with Section 1557 by programs and activities administered by the
                Department.
                 Response: The regulations implementing Section 1557's four
                underlying statutes already contain provisions addressing access to
                review of covered entities' records of compliance.\254\ The language in
                the 2016 Rule to this effect was unnecessary, as OCR has the tools to
                review records and sources of information under existing regulations.
                ---------------------------------------------------------------------------
                 \254\ See 45 CFR 90.45, Sec. 91.31 (Age Act) and Sec. 80.6(c)
                (Title VI); 45 CFR 84.61 (Section 504 incorporating 45 CFR 80.6(c));
                Sec. 86.71, as finalized here (Title IX incorporating 45 CFR
                80.6(c)).
                ---------------------------------------------------------------------------
                f. Prohibitions on Intimidation and Retaliation (Repeal of Sec.
                92.303(d) of the 2016 Rule)
                 The Department proposed to repeal Sec. 92.303(d) of the 2016 Rule,
                which concerns intimidation and retaliation provisions that pertain to
                the Department.
                 Comment: Several commenters contended that under the proposed rule,
                those bringing Section 1557 claims would no longer be explicitly
                protected from retaliation and discrimination.
                 Response: The regulations implementing Section 1557's four
                underlying statutes already contain provisions against intimidation and
                retaliation as appropriate.\255\ The language in the 2016 Rule to this
                effect was unnecessary. Moreover, OCR ensures the confidentiality of
                complainants under all the statutes it enforces, to the extent
                permitted by law and consistent with OCR's investigative needs. In some
                cases, the Freedom of Information Act, the APA, or other laws may
                require disclosure of certain information provided by complainants.
                ---------------------------------------------------------------------------
                 \255\ See 45 CFR 80.7(e) (Title VI); Sec. 91.45 (Age Act); 45
                CFR 84.61 (Section 504 incorporating 45 CFR 80.7(e)); Sec. 86.71,
                as finalized here (Title IX incorporating 45 CFR 80.7(e)).
                ---------------------------------------------------------------------------
                g. Perpetuating Discrimination by Assistance and Utilizing Criteria or
                Methods of Administration (Repeal of Sec. 92.101(b)(1)(ii),
                (b)(3)(ii), and (b)(4)(ii) of the 2016 Rule)
                 The Department proposed to repeal Sec. 92.101(b)(1)(ii) and Sec.
                92.101(b)(4)(ii), which prohibited significant assistance to any
                agency, organization, or person that discriminates on the basis of
                race, color, national origin, or age. The Department also proposed to
                repeal Sec. 92.101(b)(3)(ii), which prohibited utilization of criteria
                or methods of administration that have the effect of subjecting
                individuals to discrimination on the basis of sex.
                 Comment: One commenter objected to repealing the prohibition on the
                utilization of criteria or methods of administration that have the
                effect of subjecting individuals to discrimination on the basis of sex.
                Arguing that Section 1557 is its own authority, the commenter stated
                that it is irrelevant that the Title IX regulations do not
                [[Page 37204]]
                contain a disparate impact provision. Some commenters also contended
                that removing the ``significant assistance'' provision would undermine
                enforcement.
                 Response: The prohibition on perpetuating discrimination by
                providing significant assistance to any agency, organization, or person
                that discriminates is identified only in the Title IX and Section 504
                regulations, as applied to sex and disability discrimination claims;
                \256\ the 2016 Rule applied it also to claims on the basis of race,
                color, national origin, or age. Similarly, as discussed above in the
                section on discrimination on the basis of sex, there is no disparate
                impact language in the Department's Title IX regulations, but the 2016
                Rule made such language applicable to sex discrimination claims brought
                under Section 1557. For the reasons given earlier in this section, the
                Department considers it appropriate to rely on the enforcement
                mechanisms appropriate to each underlying civil rights statute, rather
                than to create a new and confusing civil rights regulatory framework
                specific to the enforcement of Section 1557.
                ---------------------------------------------------------------------------
                 \256\ See 45 CFR 84.4(b)(1)(v) (Section 504); Sec. 86.31(b)(6),
                as finalized here (Title IX).
                ---------------------------------------------------------------------------
                h. Notices of Nondiscrimination Rights and Statement of
                Nondiscrimination Under the 2016 Rule (Repeal of Sec. 92.8 of the 2016
                Rule)
                 The Department proposed to repeal Sec. 92.8 of the 2016 Rule,
                which required a notice informing individuals about nondiscrimination
                and accessibility requirements, such as the sample notice and
                nondiscrimination statement at Appendix A to Part 92.
                 Comment: Some commenters contended that HHS did not consider how
                the removal of the 2016 Rule's notice provisions may result in
                decreased access to, and utilization of, healthcare by people with
                disabilities, people with LEP, older adults, people who are LGBT, and
                other vulnerable populations. These commenters argued that with the
                notice provision's removal, these protected populations will be limited
                in knowing their rights under Federal civil rights laws, and in knowing
                how to file complaints with OCR if faced with discrimination in a
                healthcare setting. Others stated that the Department did not provide
                an evidentiary basis for what it deemed would be a ``negligible''
                impact on people with LEP or ``additional societal costs'' as a result
                of removing the notice provisions. Commenters proposed that instead of
                eliminating the notice provision, the Department should consider
                requiring covered entities to provide notice on an annual basis, when
                updated, and upon request, in order to harmonize with the Health
                Insurance Portability and Accountability Act (HIPAA)'s annual notice
                requirements. Other commenters similarly proposed that the Department
                should consider specifying a number of times that a covered entity
                should send notice to individuals over the course of a year.
                 Response: The regulations implementing Section 1557's four
                underlying statutes already contain notice provisions.\257\ The
                language in the 2016 Rule to this effect was unnecessary.
                ---------------------------------------------------------------------------
                 \257\ See 45 CFR 80.6 and Appendix to Part 80 (Title VI), Sec.
                84.8 (Section 504), Sec. 86.9 (Title IX) and Sec. 91.32 (Age Act).
                ---------------------------------------------------------------------------
                 Individuals belonging to any protected category under Section 1557,
                including those with disabilities or LEP, remain covered under existing
                standards regarding notice. The Department is unaware of data
                suggesting that those regulations have been or are inadequate to their
                purpose of making individuals aware of their civil rights. To the
                extent that it discovered such data, it would consider revising each
                regulation as appropriate.
                 Each of the relevant underlying regulations has its own unique
                standards on providing notice, tailored to the purposes of each civil
                rights statute.\258\ Compressing these into a single standard under the
                2016 Rule has led to an unjustifiable burden and understandable
                confusion. The Department's estimates of regulatory burden are
                discussed in the RIA.
                ---------------------------------------------------------------------------
                 \258\ Title VI, 45 CFR 80.6(d), and the Age Act, 45 CFR 91.32,
                contain general requirements to provide notice. Section 504 requires
                more: A covered entity must ``take appropriate initial and
                continuing steps to notify [individuals] that it does not
                discriminate on the basis of [disability]'' and include this
                information in its ``recruitment materials and publications.'' 45
                CFR 84.8. Title IX goes even further: A covered entity must
                ``prominently'' display its notice of nondiscrimination in ``each
                announcement, bulletin, catalog, or application form which it makes
                available to any [covered person], or which is otherwise used in
                connection with the recruitment of students or employees'' and not
                ``distribute a publication . . . which suggests, by text or
                illustration, that such [covered entity] treats applicants,
                students, or employees differently on the basis of sex except as
                such treatment is permitted by [Title IX].'' 45 CFR 86.9.
                ---------------------------------------------------------------------------
                 Comment: Some commenters stated the Department should clarify when
                the notice and taglines requirements will no longer be effective with
                respect to timeframes such as open enrollment for Exchanges, employer-
                sponsored plans, and Medicare. Most of these communications are subject
                to the current notice and taglines requirements under the 2016 Rule.
                Commenters sought clarification from the Department as to whether OCR
                will enforce the notice and taglines requirement against any covered
                entity from the date of the proposed rule (June 14, 2019).
                 Response: The changes made in this final rule will be effective 60
                days from the publication of this final rule in the Federal Register.
                The 2016 Rule is in effect until that time, except as enjoined or
                vacated by courts.
                 Comment: Several commenters requested that the Department retain
                parts of Sec. 92.8 of the 2016 Rule that require the designation of a
                responsible employee and grievance procedures, and the text of sample
                grievance procedures in Appendix C to Part 92. They said that retaining
                these provisions would increase access to healthcare and retain uniform
                responsible employee and grievance procedures.
                 Response: The Department believes it is appropriate to rely on the
                regulatory framework that has already been set forth for Section 1557's
                four underlying statutes. To the extent that those implementing
                regulations have responsible employee and grievance procedures, they
                are sufficient for enforcement of Section 1557.
                i. Summary of Regulatory Changes
                 For the reasons described in the proposed rule and considering the
                comments received, the Department finalizes Sec. 92.5, and the
                proposed repeal of Sec. Sec. 92.6, 92.7, 92.8, 92.101, 92.301, 92.302,
                92.303, and Appendices A and C of the 2016 Rule, without change.
                (7) Relationship to Other Laws in Proposed Sec. 92.6, and Repeal of
                Sec. 92.2(b) and 92.3 of the 2016 Rule
                 The Department proposed to repeal Sec. Sec. 92.2(b) and 92.3 of
                the 2016 Rule, which addressed the application and relationship of
                Section 1557 and the 2016 Rule to other laws. The Department proposed
                instead a new Sec. 92.6. The new Sec. 92.6(a) states that nothing in
                the 1557 regulations shall be construed to invalidate or limit the
                rights, remedies, procedures, or legal standards applicable under Title
                VI, Title VII, Title IX, the Age Act, or Section 504, or to supersede
                State laws that provide additional protections against discrimination
                on any basis described in Sec. 92.2. The new Sec. 92.6(b) states that
                insofar as the application of any requirement under the Section 1557
                regulations would violate, depart from, or contradict definitions,
                exemptions, affirmative rights, or protections provided by any of the
                statutes cited in paragraph (a) of this section or provided
                [[Page 37205]]
                by the Architectural Barriers Act of 1968 (42 U.S.C. 4151 et seq.); the
                Americans with Disabilities Act of 1990, as amended by the Americans
                with Disabilities Act Amendments Act of 2008 (42 U.S.C. 12181 et seq.);
                Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C.
                794d); the Coats-Snowe Amendment (42 U.S.C. 238n); the Church
                Amendments (42 U.S.C. 300a-7); the Religious Freedom Restoration Act
                (42 U.S.C. 2000bb et seq.); Section 1553 of the Patient Protection and
                Affordable Care Act (42 U.S.C. 18113); Section 1303 of the Patient
                Protection and Affordable Care Act (42 U.S.C. 18023); the Weldon
                Amendment (Consolidated Appropriations Act, 2019, Pub. L. 115-245, Div.
                B sec. 209 and sec. 506(d) (Sept. 28, 2018)); or any related,
                successor, or similar Federal laws or regulations, such application
                shall not be imposed or required.
                a. Conscience Laws
                 Comment: Some commenters supported revising the Section 1557 Rule
                to explicitly identify the Federal public consensus that conscience
                statutes reflect, in order to ensure appropriate protection for all
                civil rights. Some noted that the Coats-Snowe and Church Amendments
                were passed by Congress and signed into law on a bipartisan basis,
                reflecting explicit protections from discrimination on the Federal,
                State, or local level if healthcare providers or hospitals seek to be
                exempted from participation in the performance or training for
                abortions.
                 Some commenters supported including references to conscience and
                religious freedom laws in Sec. 92.6(b), stating that protecting the
                conscience rights of healthcare providers also protects patients by
                protecting trust between patients and providers, and allowing providers
                who entered healthcare on the basis of moral convictions to serve those
                who are ill consistent with that ethic. They also stated that providers
                must exercise professional judgment as to what constitutes the best
                interest of the patient. Commenters stated that respect for the
                autonomy of the patient should not be misconstrued to create coercive
                obligations on providers overriding the best interest of the patient.
                Some stated that the 2016 Rule resulted in a ``Hobson's choice'' of
                options for certain providers, who were required under the rule to
                either violate their ethical pledges to Do No Harm or their
                longstanding oaths as physicians, or comply with the 2016 Rule and be
                forced to perform abortions. Some commenters also suggested that if
                those providers complied with laws like Title VII and conscience laws
                that require religious accommodation, they could risk noncompliance
                with the 2016 Rule, or vice versa. Some of those commenters contended
                that coercing providers to compromise their moral integrity negatively
                impacts both provider and patient, and ultimately hurts the provider's
                ability to provide patient care. If facing the threat of coercion, such
                commenters said, providers will continually face escalating moral
                dilemmas in the practice of their job, resulting in stress and burnout
                in a time when physician shortages are already increasing.
                 Other commenters opposed the language in Sec. 92.6(b), saying that
                the proposed rule construes the Federal conscience protections more
                broadly than existing law allows. They contended conscience protections
                and religious liberty are meant for individuals, not entities, and that
                healthcare systems and entities cannot have the right of conscience,
                because the notion of conscience is limited to individuals. Some
                commenters also recommended that instead of removing gender identity
                and termination of pregnancy language and having the language in Sec.
                92.6(b) concerning conscience and religious freedom statutes, the
                Department should merely insert a narrow religious exemption, for they
                asserted that preventing discrimination on the basis of gender identity
                or termination of pregnancy is more critical than religious freedom
                rights, which should be more heavily scrutinized for pretextual
                discrimination. Other commenters stated that conscience and religious
                protections under the current statutes are sufficient and incorporating
                conscience or religious exemptions is unnecessary. Some opposed
                referring to the Coats-Snowe Amendment in Sec. 92.6(b), saying that it
                would allow healthcare providers to decline to make medical care
                available to any patient based on personal beliefs. Some added that the
                Department does not have the authority to interpret statutes such as
                the Coats-Snowe Amendment to limit or supersede Section 1557, which
                should be seen as controlling law. One commenter stated that Federal
                conscience statutes are not applicable to the ACA because they are not
                mentioned in the ACA.
                 Response: Section 1557 and the ACA did not repeal any Federal
                conscience law. Indeed, ACA Sec. 1303 specifically provides that
                ``[n]othing in [the ACA] shall be construed to have any effect on
                Federal laws regarding--(i) conscience protection; (ii) willingness or
                refusal to provide abortion; and (iii) 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.'' 42 U.S.C. 8023(c)(2). At the time of its passage, the
                President stated that ``[u]nder the [ACA], longstanding Federal laws to
                protect conscience (such as the Church Amendment, 42 U.S.C. 300a-7, and
                the Weldon Amendment, section 508(d)(1) of Pub. L. 111-8) remain intact
                and new protections prohibit discrimination against healthcare
                facilities and healthcare providers because of an unwillingness to
                provide, pay for, provide coverage of, or refer for abortions.'' \259\
                New law is to be interpreted consistently with existing law wherever
                possible, and the Department sees no conflict between Section 1557 and
                preexisting Federal conscience statutes.
                ---------------------------------------------------------------------------
                 \259\ Executive Order 13535, ``Patient Protection and Affordable
                Care Act's Consistency with Longstanding Restrictions on the Use of
                Federal Funds for Abortion'' (March 24, 2010).
                ---------------------------------------------------------------------------
                 This final rule emphasizes that the Section 1557 regulation will be
                implemented consistent with various statutes enacted by Congress,
                including conscience and religious freedom statutes. This should not be
                a controversial statement, nor should it even be necessary to add, as
                the Department is always obligated to comply with relevant Federal
                statutes. But the fact that so many commenters found this provision
                objectionable is itself a reminder of why such a provision is needed.
                The fact that the 2016 Rule was the subject of litigation and
                injunctive relief, in part because of plaintiffs' claim that the 2016
                Rule did not clearly state that it would be enforced consistent with
                conscience and religious freedom statutes, is also a reason the
                Department believes it is appropriate to make the issue clearer in this
                final rule. This final rule does not purport to construe the statutes
                referenced in this section, so it cannot be construing them too broadly
                (or too narrowly). It would be inappropriate to replace Sec. 92.6(b)'s
                language with a religious exemption, whether narrow or broad, because
                Sec. 92.6(b) neither adds to nor takes away from the conscience and
                religious freedom statutory language that Congress has enacted.
                 Commenters who discuss the gender identity and termination of
                pregnancy provisions of the 2016 Rule in this context are confusing two
                different issues. As stated above, this final rule eliminates the 2016
                Rule's provisions related to gender identity for numerous
                [[Page 37206]]
                legal and policy reasons that have nothing to do with conscience
                protection, and it eliminates the 2016 Rule's provisions on termination
                of pregnancy because they failed to incorporate Title IX's abortion-
                neutrality language (which goes much farther than any mere protection
                for individual conscientious objectors). In neither case could the
                Department's concerns have been adequately addressed by permitting
                individuals to claim a conscientious exemption from those objectionable
                provisions.
                 Comment: Many providers with conscientious or religious concerns
                stated that their medical judgment is based upon a review of the
                clinical evidence, and that medical ethics requires that they act in
                accordance with their best medical judgment. For example, some
                commenters contended that they have practices, such as in the
                obstetrics and gynecology field, which are specialized to the
                biological sex of females based on a binary distinction between males
                and females. Others had objections because of their moral and religious
                convictions concerning specific procedures that they sincerely
                believed, both in their medical judgment and ethically, would endanger
                the health and wellbeing of a person.
                 Response: By respecting medical professionals' judgment, the
                Department protects their right and responsibility to follow medical
                ethics in treating patients to the best of their ability. In their
                objections to abortion, sex-reassignment procedures, or other
                treatments covered by the 2016 Rule, some providers assert that not
                only their medical judgment but also their conscientious or religious
                beliefs would be burdened by such procedures. The Department believes
                that the best way to avoid such burdens on conscience is, instead of
                requiring individual objectors to assert claims under RFRA or other
                applicable laws, to avoid regulatory requirements that would have
                forced them to provide such procedures in the first place, as well as
                to ensure that remaining requirements are interpreted consonant with
                the applicable Federal conscience statutes.\260\ This will protect both
                providers' medical judgment and their consciences, thus helping to
                ensure that patients receive the high-quality and conscientious care
                that they deserve.
                ---------------------------------------------------------------------------
                 \260\ See California v. Azar, at *24 (``HHS acted well within
                its authority in deciding how best to avoid conflict with the
                Federal conscience laws.'').
                ---------------------------------------------------------------------------
                 Comment: Some commenters argued that religious or conscience
                exemptions were used as a pretext to conceal animus against LGBT
                individuals. Commenters expressed concerns that the proposed rule would
                improperly prioritize conscience and religious freedom rights over LGBT
                rights or civil rights in general. However, others, such as hospital
                associations that expressed support for care regardless of gender
                identity and sexual orientation, explained that they also support
                appropriate protections for the reasonable accommodation of a nurse or
                other provider who may assert a sincere conscientious objection to
                participating in a particular medical procedure. Other providers stated
                that the exemption they seek is from providing certain treatments, not
                from treating certain patients. Some submitted their hospital
                nondiscrimination policies, contending those policies do not include
                blanket denial of healthcare treatment for LGBT individuals, and in
                many cases expressly prohibit discrimination on the basis of gender
                identity or sexual orientation, but that they nonetheless seek limited
                exemptions on the basis of sincerely held religious and moral
                convictions. Some individual, institutional, and religious groups
                affiliated with healthcare providers also provided comments stating
                that both in policy and in practice, they have never refused to care
                for a patient on the grounds of their identity as an LGBT individual.
                They stated that they object to being required to perform services that
                violate sound medical judgment, ethical convictions, or religious
                beliefs about the dignity of human beings. Commenters also submitted
                surveys finding healthcare professionals experienced pressure, coercion
                or punishment for not participating in training, performing a
                procedure, or writing a prescription when they had medical or
                scientific objections.
                 Response: The Department recognizes that members of the public hold
                different opinions concerning conscience and religious freedom laws and
                their interplay with various health contexts, including with respect to
                LGBT concerns. This final rule does not, however, create any new
                conscience or religious freedom exemptions beyond what Congress has
                already enacted.
                 Comment: Some commenters contend that women of color are more
                likely to rely on religious hospitals to receive care, and thus women
                of color will be more likely to be affected by religious exemptions
                that allow religious hospitals to deny certain reproductive care.
                Others opposed inclusion of references to conscience and religious
                freedom laws, stating that the danger of losing Federal funds is the
                only incentive for covered entities to offer more abortion,
                contraception, sterilization, gender identity affirming, or sex
                reassignment services. Other commenters stated that conscience laws
                were intended to protect health professionals from precisely that form
                of government coercion.
                 Some commenters stated that the proposed rule, in particular
                concerning the Church Amendments, 42 U.S.C. 300a-7, is inconsistent
                with EMTALA, because the conscience exemptions would deny emergency and
                stabilizing care, including with respect to abortion or sterilization.
                Other commenters stated that the rule is consistent with EMTALA,
                because EMTALA requires protection of the ``unborn child.''
                 Response: The Department is not aware of any instance to date where
                a facility required to provide emergency care under EMTALA was unable
                to do so because of objections protected by the Church Amendments. This
                final rule does not adopt any stance on how hypothetical conflicts
                between the Church Amendments and EMTALA ought to be resolved. The
                Department intends to read every law passed by Congress in harmony to
                the fullest extent possible, so that all laws are given their fullest
                possible effect. Commenters' other policy concerns about the possible
                healthcare effects of the conscience laws are among the many
                complicated factors that Congress had to balance in the texts of the
                separate statutes, and it is not the Department's job to overturn the
                results of that legislative process.
                 Comment: One commenter compared the proposed rule with the 2019
                Conscience Rule and alleged that the Department's recent actions of
                decreasing protections for patients and increasing protections for
                providers run contrary to actual public sentiment. The commenter
                alleged that between 2008 and January 2018, the Department received
                fewer than 50 complaints regarding violations of Federal religious or
                conscience statutes while receiving 30,000 complaints of other civil
                rights discrimination in 2017 alone. Other commenters stated that the
                2019 Conscience Rule violates EMTALA, and results in the denial of
                transition-related surgeries or abortion services in emergencies,
                because conscience statutes allow exemptions from performance of
                sterilizations or abortions. Commenters also recommended that the
                Department delay finalizing the proposed rule pending the outcome of
                litigation challenging the 2019 Conscience Rule, in order to provide
                clarity and finality, and to reduce litigation risk as regards the
                construction of Section 1557 with conscience statutes.
                [[Page 37207]]
                 Response: This final rule is separate from the 2019 Conscience
                Rule. It does not implement that rule, and it does not implement the
                statutes implemented by that rule. Several courts have vacated the 2019
                Conscience Rule before its effective date, but none of those courts
                issued any order against the conscience statutes themselves,\261\ which
                the Conscience Rule sought to implement and which this final rule
                references. Because this final rule does not refer to or rely on the
                2019 Conscience Rule, there is no reason to delay finalization of this
                rule pending further litigation over the 2019 Conscience Rule.
                ---------------------------------------------------------------------------
                 \261\ See New York v. United States Dep't of Health & Human
                Servs., 414 F. Supp. 3d 475 (S.D.N.Y. 2019); City & Cty. of San
                Francisco v. Azar, 411 F. Supp. 3d 1001 (N.D. Cal. 2019); Washington
                v. Azar, No. 2:19-CV-00183-SAB, 2019 WL 6219541 (E.D. Wash. Nov. 21,
                2019).
                ---------------------------------------------------------------------------
                b. Religious Freedom Restoration Act
                 Comment: Some commenters said that the proposed rule's inclusion of
                the Religious Freedom Restoration Act (``RFRA'') in Sec. 92.6(b) was
                unclear and confusing. Others said that it should be excluded because
                it would allow providers to deny needed healthcare. Other commenters
                supported inclusion of RFRA, agreeing that it is an important
                protection for religious conscience from government-imposed burdens.
                Commenters also pointed out that the Federal government has clearly
                articulated its commitment to RFRA and religious freedom laws under a
                recent executive order \262\ and the subsequent Attorney General
                Memorandum \263\ to executive departments and agencies that ``Congress
                has taken special care with respect to programs touching on abortion,
                sterilization, and other procedures that may raise religious conscience
                protections.'' \264\ One commenter supported the Department's explicit
                acknowledgment that Section 1557 is subject to RFRA, stating that
                religious organizations have had to repeatedly go to court to vindicate
                their conscience rights against the Department's enforcement of the
                2016 Rule. Others said that referring to RFRA accurately reflects
                statutory text and Congressional intent, and would correct a legal
                misinterpretation of Section 1557 that has been recognized as such by
                the Franciscan Alliance court.
                ---------------------------------------------------------------------------
                 \262\ Executive Order 13798 on Promoting Free Speech and
                Religious Liberty, 82 FR 21675 (May 4, 2017).
                 \263\ Memorandum of the Attorney General (Oct. 6, 2017), https://www.justice.gov/opa/press-release/file/1001891/download.
                 \264\ Id.
                ---------------------------------------------------------------------------
                 Response: Congress explicitly stated that RFRA applies to ``all
                Federal law, and the implementation of that law, whether statutory or
                otherwise, and whether adopted before or after November 16, 1993 . . .
                unless such law explicitly excludes such application by reference to
                this chapter.'' \265\ Section 1557 does not explicitly exclude such
                application, so the Department is bound to enforce Section 1557 in
                compliance with RFRA. The Department agrees with the court in
                Franciscan Alliance that particular provisions in the 2016 Rule
                violated RFRA as applied to private plaintiffs.\266\ In order to ensure
                that Section 1557 regulations are now interpreted consistently with,
                and implemented in compliance with, RFRA, the Department considers it
                appropriate to specify this explicitly.
                ---------------------------------------------------------------------------
                 \265\ 42 U.S.C. 2000bb-3.
                 \266\ Franciscan Alliance, 2019 WL 5157100 at *9 (``[T]he Court
                holds that the Rule, which expressly prohibits religious exemptions,
                substantially burdens Private Plaintiffs' religious exercise in
                violation of RFRA.'')
                ---------------------------------------------------------------------------
                 Comment: Some commenters stated that the text of the Section 1557
                statute does not contain a religious exemption, and therefore asked the
                Department not to include a religious exemption, either explicitly or
                by reference in Sec. 92.6(b). Other commenters stated that exemptions
                on religious bases should be blanket exemptions, not case-by-case
                exemptions as outlined in RFRA.
                 Response: This final rule does not craft a religious exemption to
                Section 1557. Congress has already created various religious and
                conscience protections in healthcare by enacting several statutes,
                including RFRA, healthcare conscience statutes, and the religious
                organization exception in Title IX. This final rule simply states that
                the Section 1557 regulation will be implemented consistent with those
                statutes.
                c. Title IX
                 Comment: Some commenters opposed including reference to the Title
                IX statutory religious exemption in Sec. 92.6(b). They said that
                Section 1557 does not require or authorize Title IX religious or
                abortion exemptions, because these are limited to educational
                institutions, and are improper in the healthcare context. Others
                expressed concern that Section 1557 and Title IX would be subject to
                exemptions that HHS does not apply to its rules enforcing Title VI.
                 Other commenters stated that it is unnecessary and unwise to change
                the standard for the religious exemption under Title IX, and pointed to
                the legislative history of Title IX, where the Conference Committee
                rejected an amendment proposed by Senator Hatch to loosen the standard
                for the religious exemption. Commenters stated that Sec. 92.101(c) of
                the 2016 Rule took an inconsistent analysis by failing to incorporate
                Title IX's religious and abortion exemptions, despite incorporating
                exemptions from the other three Federal civil rights laws referenced in
                Section 1557.
                 Still other commenters stated that the Title IX exemption should
                not apply broadly to large religious institutional healthcare
                facilities, or that conscience protections and religious liberty cannot
                apply to institutions like hospitals or healthcare systems because they
                cannot have the right of conscience: They suggested that conscience is
                limited to individuals and that an institution is not a person. Other
                commenters disagreed and pointed to legislative history to recognize
                that the protections under Title IX's religious exemption are not just
                for individuals but for institutions.
                 Response: The text of Title IX applies its religious exemption to
                institutions, so there should be no question that religious exemptions
                can apply to institutions as well as individuals.\267\ As discussed
                above regarding termination of pregnancy, the Franciscan Alliance court
                vacated portions of the 2016 Rule for failing to incorporate Title IX's
                exemption for religious institutions. More generally, the Supreme Court
                in Burwell v. Hobby Lobby held that RFRA can apply to for-profit
                corporations. 573 U.S. 682 (2014). And that holding parallels other
                Supreme Court precedent making clear that organizations may engage in
                exercises of religion protected by the First Amendment. See, e.g.,
                Masterpiece Cakeshop, Ltd. v. Colo. Civil Rights Comm'n, 138 S. Ct.
                1719, 1732 (2018); Hosanna-Tabor Evangelical Lutheran Church & Sch. v.
                EEOC, 565 U.S. 171, 199 (2012); Church of the Lukumi Babalu Aye, Inc.
                v. City of Hialeah, 508 U.S. 520, 525-26, 547 (1993).
                ---------------------------------------------------------------------------
                 \267\ See 20 U.S.C. 1681(a)(3) (``this section shall not apply
                to an educational institution which is controlled by a religious
                organization if the application of this subsection would not be
                consistent with the religious tenets of such organization''); 20
                U.S.C. 1687(4) (excluding ``any operation of an entity which is
                controlled by a religious organization if the application of section
                1681 of this title to such operation would not be consistent with
                the religious tenets of such organization'').
                ---------------------------------------------------------------------------
                 Under the Civil Rights Restoration Act amendments to Title IX, the
                Title IX religious exemption is no longer limited to educational
                institutions controlled by religious organizations: Any educational
                operation of an entity may be exempt from Title IX due to control by a
                religious organization.\268\ Section 1557
                [[Page 37208]]
                incorporates the statutory scope of Title IX, so it is appropriate for
                this rule to incorporate the Title IX statutory language concerning
                religious institutions and abortion neutrality. Although much of Title
                VI case law can be applied to Title IX situations, the parallel is not
                perfect because Title IX contains several important statutory
                exemptions that are absent from Title VI. These are mentioned above in
                the section on discrimination on the basis of sex.\269\
                ---------------------------------------------------------------------------
                 \268\ Id.
                 \269\ 20 U.S.C. 1681(a)(6)(B); 34 CFR 106 et seq.
                ---------------------------------------------------------------------------
                 Comment: Commenters stated that adding the Title IX exemption for
                religious entities violates the Establishment Clause, because it would
                force third parties to subsidize or bear the costs of religious
                exercise, citing Cutter v. Wilkson, 544 U.S. 709 (2005), Lee v.
                Weisman, 505 U.S. 577 (1992), and Estate of Thornton v. Caldor, Inc.
                472 U.S. 703 (1985). Commenters indicated that religious exemptions
                must take an adequate account of the burdens a requested accommodation
                may impose on nonbeneficiaries. Commenters similarly suggested that the
                rule's requirement that the Section 1557 rule be implemented consistent
                with RFRA would violate the Establishment Clause and should be limited
                to instances where no third party is harmed by application of RFRA.
                 Response: Neither RFRA (as applied to Federal government actions),
                nor Title IX's statutory exemptions, have ever been held
                unconstitutional by the Supreme Court. The Court has upheld Title VII's
                statutory exemption for religious organizations,\270\ and has denied
                that statutory exemptions of this type violate the Establishment
                Clause.\271\ The Department will comply with all relevant court
                rulings.
                ---------------------------------------------------------------------------
                 \270\ Corporation of the Presiding Bishop of the Church of Jesus
                Christ of Latter-Day Saints v. Amos, 483 U.S. 327, 338-40 (1987);
                see also Walz v. Tax Commn. of City of New York, 397 U.S. 664 (1970)
                (upholding the constitutionality of a state's statutory property tax
                exemption for religious organizations); Id. at 675 (``The grant of a
                tax exemption is not sponsorship since the government does not
                transfer part of its revenue to churches but simply abstains from
                demanding that the church support the state. No one has ever
                suggested that tax exemption has converted libraries, art galleries,
                or hospitals into arms of the state or put employees `on the public
                payroll.' There is no genuine nexus between tax exemption and
                establishment of religion.'').
                 \271\ Corporation of the Presiding Bishop of the Church of Jesus
                Christ of Latter-Day Saints v. Amos, at 336-37 (``We agree with the
                District Court that this purpose does not violate the Establishment
                Clause. . . . A law is not unconstitutional simply because it allows
                churches to advance religion, which is their very purpose.''); Id.
                at 339 (``It cannot be seriously contended that [Title VII's
                statutory exemption] impermissibly entangles church and state; the
                statute effectuates a more complete separation of the two and avoids
                the kind of intrusive inquiry into religious belief that the
                District Court engaged in in this case.'').
                ---------------------------------------------------------------------------
                d. Other Laws and Cases
                 Comment: The Department received comments supporting the express
                mention of Section 1303 of the ACA \272\ in proposed Sec. 92.6. These
                commenters contended that this helps clarify the prohibition on
                mandating QHPs to provide abortions, and that it could not have been
                Congress's intent to mandate abortion coverage in Section 1557. Section
                1303 expressly leaves it up to issuers of health plans to decide not to
                cover abortion. Other comments stated that Section 1303 should not be
                expressly mentioned in this rule and that termination of pregnancy
                should remain as a prohibited basis of discrimination under the Section
                1557 rule, notwithstanding Section 1303.
                ---------------------------------------------------------------------------
                 \272\ 42 U.S.C. 18023.
                ---------------------------------------------------------------------------
                 Response: In Section 1303, Congress specified that nothing in the
                ACA (therefore including Section 1557) ``shall be construed to have any
                effect on Federal laws regarding (i) conscience protection; (ii)
                willingness or refusal to provide abortion; and (iii) discrimination on
                the basis of willingness or refusal to provide, pay for, cover, or
                refer for abortion or to provide or participate in training to provide
                abortion'' (emphasis added). The Department considers it appropriate to
                finalize Sec. 92.6 to indicate that the Section 1557 regulation will
                be implemented consistent with Section 1303, as that provision is
                relevant to the interpretation of the Federal laws that Section 1557
                incorporates by reference.
                 Comment: The Department received comments from State public
                officials raising concerns about the 2016 Rule's constitutionality.
                State public officials contended that the 2016 Rule violated the
                Spending Clause because the Federal government did not provide adequate
                notice by clear statement and opportunity to agree to the Section 1557
                Rule's new conditions on receipt of Federal financial assistance.
                States also raised objections under the Eleventh Amendment to the
                Department-initiated Section 1557 enforcement actions. States
                identified their obligation to protect the First Amendment rights to
                free exercise of religion of their citizenry. However, these State
                commenters noted that the proposed rule's removal of the definition of
                ``on the basis of sex,'' and the addition of the religious and abortion
                exemptions, would address these concerns.
                 Other commenters stated that when the Department said in the 2019
                NPRM that State and local entities are better suited than the Federal
                government to address gender identity discrimination, this was contrary
                to constitutional law principles and undermined the right to be free
                from discrimination.
                 Response: The Department is not aware of any Supreme Court
                precedent that would call into question the constitutionality of its
                reasoning about federalism as laid out in the 2019 NPRM.\273\ The
                Department believes that this final rule resolves the concerns States
                had about the 2016 Rule's constitutionality.
                ---------------------------------------------------------------------------
                 \273\ See 84 at 27857 (2019 NPRM discussion of ``Sensitive
                Balancing of Competing Interests at the Local Level'' at Part g).
                ---------------------------------------------------------------------------
                 Comment: Some comments from State public officials stated that the
                2016 Rule conflicted with State laws on religious accommodations and
                independent medical judgment of healthcare providers. A different group
                of State public officials submitted a separate joint comment stating
                that their States' civil rights legislation and/or regulations
                prohibited discrimination on the basis of gender identity or sexual
                orientation, and that the proposed rule would remove the consistency of
                their laws with the 2016 Rule. They argued that State insurance
                agencies acted first to promulgate regulations after passage of Section
                1557 in 2010, assuming that Section 1557 prohibited gender identity
                discrimination. Some States also said that the proposed rule's
                incorporation of Federal conscience statutes would result in conflict
                with State laws, or with other Department rules requiring covered
                entities to provide care to all (e.g., vaccination care).
                 Some States said that as employers they had difficulty resolving
                religious accommodation laws with Section 1557. Others stated they had
                no difficulties resolving consumer complaints of discrimination on the
                basis of gender identity.
                 Response: The Department agrees that States have a public interest
                in enforcement of their statutes, including conscience and religious
                freedom statutes. This final rule respects Federalism: It neither
                interferes with State laws on conscience protections and medical
                judgment, nor does it interfere with State laws that provide additional
                protections (so long as these do not violate other Federal statutes).
                The rule also explicitly provides that Section 1557 will not be taken
                to supersede State laws that provide additional protections against
                discrimination on the enumerated grounds. The Department is not aware
                of actual, as opposed to hypothetical, conflicts between the statutes
                incorporated here and other laws or
                [[Page 37209]]
                regulations that the Department enforces.
                 Comment: A commenter supported including the reference to Section
                1553 of the ACA in Sec. 92.6 in order to protect nurses who have
                objections to participating in assisted suicide, promote trust in the
                nurse-patient relationship, and keep the profession open to candidates
                who want to serve as nurses but object to participation in assisted
                suicide.
                 Commenters supported the proposal's specification that the proposed
                regulation not be applied in a manner that conflicts with or supersedes
                exemptions, rights, or protections contained in several civil rights
                statutes, such as the Architectural Barriers Act of 1968, the Americans
                with Disabilities Act of 1990 (as amended by the Americans with
                Disabilities Act Amendments Act of 2008), and Section 508 of the
                Rehabilitation Act of 1973.
                 Some commenters requested that the word ``obligations'' be added in
                order to specify that the proposed regulation not be applied in a
                manner that conflicts with or supersedes the exemptions, rights,
                protections or obligations contained in several civil rights statutes.
                This addition would help clarify that this consideration is intended to
                help reduce redundancy, compliance burdens, and confusion for
                healthcare providers.
                 Response: The Department appreciates all these comments in support
                of the proposed rule. The Department declines to add the word
                ``obligations,'' as the final rule's language adequately addresses its
                interaction with other civil rights statutes.
                 Comment: One commenter noted that a number of provisions in the
                proposed rule seem to contradict portions of the recent Conscience Rule
                published by the Department.\274\ In particular, this proposed rule
                eliminates and narrows definitions advanced by the 2016 Rule, while the
                Conscience Rule expands definitions and protections. This proposed rule
                seeks to drastically cut costs of enforcement by eliminating notice and
                taglines requirements and other costs for providers, while the
                Conscience Rule will impose new costs on providers and individuals.
                Finally, this proposed rule and the Conscience Rule use different
                definitions to define health programs and activities.
                ---------------------------------------------------------------------------
                 \274\ 45 CFR part 88.
                ---------------------------------------------------------------------------
                 Response: The 2019 Conscience Rule and this final rule rely on
                different statutes, and different underlying regulations for those
                statutes, so it is not surprising that there should be differences
                between their respective definitions and protections. The four civil
                rights statutes underlying Section 1557 have implementing regulations
                containing appropriate definitions, protections, and enforcement
                mechanisms. As explained herein, the Department has now deemed most of
                the parallel provisions in the 2016 Rule to be unnecessary,
                superfluous, or unduly burdensome. Therefore the Department considers
                it appropriate to finalize a Section 1557 rule that is shorter than the
                2016 Rule and relies more substantially on those underlying
                regulations. In contrast, the 2019 Conscience Rule (which has been
                vacated and is subject to pending litigation) modified previous
                regulations that are only three sentences long, and that lack the kinds
                of definitions and enforcement mechanisms found in regulations
                implementing other civil rights laws enforced by the Department. In
                promulgating the 2019 Conscience Rule, the Department concluded more
                extensive regulations were needed in the absence of existing
                regulations containing such provisions.
                 Comment: One commenter stated that the proposed rule's changes to
                the relationship to other laws section at Sec. 92.6 are contrary to
                the requirements of Section 1557, because the 2016 Rule stated that
                neither it nor Section 1557 would apply a lesser standard than Title
                VI, Title IX, Section 504, or the Age Act. In contrast, the proposed
                rule expressly states that application of the proposed rule will not be
                required if the proposed rule violates, departs from, or contradicts a
                number of other Federal civil rights laws.
                 Response: The Department seeks to give all laws their fullest
                possible effect. It does not believe that the other laws referenced at
                Sec. 92.6 are generally in conflict with Title VI, Title IX, Section
                504, or the Age Act, except to the extent that some of them (e.g.,
                RFRA) may be specifically designed to limit the applicability of other
                Federal laws and governmental actions.
                e. Summary of Regulatory Changes
                 For the reasons described in the proposed rule and having
                considered the comments received, the Department finalizes Sec. 92.6
                and repeals Sec. Sec. 92.2(b) and 92.3 of the 2016 Rule without
                change.
                C. Section 1557 Regulation, Subpart B: Specific Applications to Health
                Programs or Activities (Sections 92.201-92.205 of the 2016 Rule)
                 The Department requested comment on the proposed retention and
                modification of the provisions in Subpart B of the Section 1557
                regulation, which imposes specific requirements on covered entities as
                regards individuals with LEP or disabilities.
                (1) Meaningful Access for Individuals With Limited English Proficiency
                (45 CFR 92.101)
                 The Department proposed Sec. 92.101(a), which states that any
                entity operating or administering a health program or activity subject
                to the Section 1557 regulation is obligated to take reasonable steps to
                ensure meaningful access to such programs or activities by LEP
                individuals. It also proposed Sec. 92.101(b), which states that OCR
                may assess how an entity balances the following four factors:
                 (1) The number or proportion of LEP individuals eligible to be
                served or likely to be encountered in the eligible service population;
                 (2) the frequency with which LEP individuals come in contact with
                the entity's health program, activity, or service;
                 (3) the nature and importance of the entity's health program,
                activity, or service; and
                 (4) the resources available to the entity and costs.
                 Section Sec. 92.101(b) retains many of the 2016 Rule's provisions
                related to access for LEP individuals. It removes definitions of the
                terms ``qualified bilingual/multilingual staff'' and ``individual with
                limited English proficiency,'' but the 2019 NPRM expressed the
                Department's commitment to interpreting those terms naturally and
                consistently with the 2016 Rule.\275\ It also repeals the 2016 Rule's
                definition of ``national origin.''
                ---------------------------------------------------------------------------
                 \275\ 85 FR 27860-61, 27866.
                ---------------------------------------------------------------------------
                 The Department requested comment on whether the proposed retention
                of some provisions that impose requirements on covered entities under
                the Section 1557 Regulation (which govern health programs or
                activities), but not on entities that only receive HHS funding for
                human services, would cause problems or confusion, and (if so) whether
                this might warrant amendments to the Department's Title VI regulation.
                 Comment: In response to the Department's request for comment
                concerning possible amendments to the underlying civil rights
                regulations, some commenters said that they were unable to provide
                meaningful comments without HHS first providing explanations and
                rationale for any proposed changes, and that unanticipated changes
                could not be
                [[Page 37210]]
                made in a final rule without first giving the public an opportunity to
                comment on those proposed changes.
                 Response: The Department did not propose changes to regulations
                other than those finalized here, but simply invited comment on whether
                to consider doing so. In this final rule, the Department does not
                implement any such changes, and in this respect finalizes the proposed
                rule without change. The Department here finalizes only those changes
                proposed in the 2019 NPRM (with minor and primarily technical changes
                to these).
                 Comment: Some commenters opposed the proposed rule's revisions to
                the requirements for meaningful access for LEP individuals, arguing
                that they weaken nondiscrimination requirements. These commenters noted
                that instead of requiring covered entities to take reasonable steps to
                provide meaningful access for each ``LEP individual eligible to be
                served or likely to be encountered,'' the proposed rule only requires
                covered entities to take steps to ensure meaningful access for ``LEP
                individuals'' generally. These commenters contend that this change will
                result in a number of LEP individuals unable to access healthcare, and
                will contribute to discrimination and to healthcare disparities for LEP
                individuals. Many commenters stated that lack of understanding in a
                medical setting could cause harm and possibly death to patients with
                LEP. One commenter emphasized the facilitative role that interpreters
                play to decrease risk associated with miscommunication between patients
                and providers. A commenter expressed concerns that healthcare services
                would dramatically decrease for individuals with LEP who are unable to
                access an interpreter. Another commenter objected to the notion that
                oral interpretation for patients would not be required. Some commenters
                also oppose the replacement of the 2016 Rule's two-factor test with a
                four-factor test. One commenter recommended replacing the term
                ``reasonable'' in the Department's LEP Guidance meaningful access
                standard with the term ``all,'' saying that the word ``reasonable''
                leaves too much room for ambiguity in its application.
                 Response: The 2016 Rule imposed a stringent requirement on covered
                entities to take reasonable steps to provide meaningful access to each
                LEP individual eligible to be served or likely to be encountered. This
                provision could potentially be interpreted to require a covered entity
                to provide language assistance services to every LEP individual it
                comes into contact with. This final rule instead follows DOJ's
                longstanding LEP guidance (under Executive Order 13166), and HHS's
                corresponding LEP guidance from 2003, by saying that a covered entity
                under Title VI must take reasonable steps to ensure meaningful access
                to its programs or activities by LEP individuals.\276\ Adopting this
                language would apply the same standard to both health and human
                services programs within the Department, and would conform to the other
                Federal agencies that follow DOJ's LEP Guidance, consistent with its
                civil-rights coordinating authority. Because Section 1557 incorporates
                the enforcement mechanisms available under Title VI (which encompasses
                LEP status under Lau v. Nichols),\277\ it is appropriate for this final
                rule to adopt the Title VI standard requiring reasonable steps to
                ensure meaningful access.
                ---------------------------------------------------------------------------
                 \276\ See 67 FR 41455 (June 18, 2002) (DOJ Guidance to Federal
                Financial Assistance Recipients Regarding Title VI Prohibition
                Against National Origin Discrimination Affecting Limited English
                Proficient Persons).
                 \277\ 414 U.S. 563 (1974).
                ---------------------------------------------------------------------------
                 This final rule also incorporates the four-factor test found in the
                DOJ LEP Guidance and reiterated in the Department's own 2003 LEP
                Guidance. That test is ``designed to be a flexible and fact-dependent
                standard,'' \278\ and is meant to strike a balance that ensures
                meaningful access by LEP individuals to critical services while not
                imposing undue burdens on small businesses, small local governments, or
                small nonprofits. As the 2019 NPRM made clear, an individualized case-
                by-case assessment of the four factors is the starting point for
                exercising the Department's enforcement discretion in language access
                cases.\279\
                ---------------------------------------------------------------------------
                 \278\ 68 FR 47314 (Aug. 8, 2003) (HHS Guidance to Federal
                Financial Assistance Recipients Regarding Title VI Prohibition
                Against National Origin Discrimination Affecting Limited English
                Proficient Persons).
                 \279\ 84 FR 27865 (June 14, 2019).
                ---------------------------------------------------------------------------
                 This final rule retains, and the Department will vigorously
                enforce, the underlying legal standard of Title VI: Recipients are
                prohibited from utilizing criteria or methods of administration which
                have the effect of subjecting individuals to discrimination on the
                basis of their race, color, or national origin, or have the effect of
                defeating or substantially impairing accomplishment of the program with
                respect to individuals on the basis of their race, color, or national
                origin. Entities that utilize such criteria or methods of
                administration have failed to take reasonable steps to ensure
                meaningful access to their programs by individuals with LEP and are
                operating their programs in violation of this final rule's prohibition
                against discrimination on the basis of national origin. All covered
                entities remain obligated to submit assurances that they will comply
                with Title VI and all other relevant civil rights law.\280\
                ---------------------------------------------------------------------------
                 \280\ See 84 FR 27860.
                ---------------------------------------------------------------------------
                 The language access provisions in this final rule are consistent
                with Title VI enforcement mechanisms and with the Department's
                longstanding guidance. Title VI enforcement mechanisms are broadly
                known to the regulated community, and the HHS LEP Guidance has been
                effective in helping covered entities comply with the statute and
                implementing regulations. The Department regards the four-factor test,
                employed since 2003, as the best way of balancing the relevant factors
                in ensuring nondiscrimination on the basis of national origin. Under
                this final rule, the Department's LEP Guidance will help covered
                entities assess their programs using the four factors to ensure
                meaningful access to their programs by individuals with LEP. By
                eliminating confusion, inconsistency, redundancy, and unnecessarily
                burdensome compliance costs, this final rule applies proven enforcement
                mechanisms and guidance to ensure access to covered programs by
                individuals with LEP.
                 Comment: Commenters stated that the proposed rule significantly
                reduces the administrative burden placed on providers. For example, the
                proposed rule will allow retail pharmacies to provide patients with
                better quality of care in a more efficient manner. Another comment
                emphasized that under the 2016 Rule, providers are required to
                physically post the information at their facilities, on their websites,
                and in any ``significant'' publications and communications. This
                example underscored that the term ``significant'' has never been
                defined by OCR, which has resulted in providers using taglines notices
                in nearly every document provided to patients. This practice was
                described as administratively burdensome and counterproductive, because
                patients already receive numerous notices mandated by the Department.
                Another commenter expressed support for the proposed rule's empowerment
                of individual entities to take reasonable steps to ensure meaningful
                access.
                 Response: The Department agrees, and recognizes the burdens imposed
                by the 2016 Rule's requirement to post notices and taglines in all
                significant communications and publications, as well as by the
                difficulty of determining the meaning of ``significant'' with
                [[Page 37211]]
                respect to the numerous and diverse types of programs covered by this
                final rule. These requirements were difficult for covered entities to
                implement due to different and overlapping language access requirements
                imposed by the Federal government and by many States.\281\ Stakeholders
                have informed the Department that the repetitive nature of these
                requirements dilutes the messages contained in significant
                communications to the point that some recipients may be disregarding
                the information entirely.\282\ In addition, many beneficiaries do not
                want to receive extra pages of information they have seen many times
                before, due to environmental concerns or annoyance.\283\ Most
                significantly, the Department has found scant evidence to demonstrate
                that repeatedly mailing all beneficiaries of Federal and other health
                programs taglines with 15 or more languages is an efficient use of
                covered entities' language access resources when the overwhelming
                majority of beneficiaries speak English.\284\ Savings from the notice
                and taglines requirements changes are described in more detail in the
                Regulatory Impact Analysis.
                ---------------------------------------------------------------------------
                 \281\ E.g., 42 U.S.C. 300gg-15(b)(2) and 300gg-19(a)(1)(B)
                (requiring standards for ensuring that the Summaries of Benefits and
                Coverage and certain notices are provided in a culturally and
                linguistically appropriate manner); 42 U.S.C. 1396d(p)(5)(A)
                (requiring HHS to distribute to States an application form for
                Medicare cost-sharing in English and 10 non-English languages); 26
                CFR 1.501(r)-4(a)(1), (b)(5)(ii) (requiring a hospital organization
                to translate certain documents, among other requirements, to qualify
                for a tax-exempt status with respect to a hospital facility); 42 CFR
                422.2262(a)(1)-(2) and 422.2264(e) (setting forth Medicare Advantage
                marketing requirements, which include requiring Medicare Advantage
                organizations to translate marketing materials into non-English
                languages spoken by 5% or more of individuals in a plan service
                area), Sec. 423.2262(a)(1)-(2) and Sec. 423.2264(e) (setting forth
                Medicare Part D marketing requirements, which include requiring Part
                D plan sponsors to translate marketing materials into non-English
                languages spoken by 5% or more of individuals in a plan service
                area); 45 CFR 155.205(c)(2)(iii)(A) (Marketplaces must post taglines
                on their websites and include taglines in documents ``critical for
                obtaining health insurance coverage or access to health care
                services through a QHP''); 68 FR 47318 (Aug. 8, 2003)--Guidance to
                Federal Financial Assistance Recipients Regarding Title VI
                Prohibition Against National Origin Discrimination Affecting Limited
                English Proficient Persons (setting forth guidance on translating
                ``vital'' documents).
                 \282\ See Aetna, ``Member Reactions to 1557 Taglines'' (Apr.
                2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0002; American Health Insurance Plans and Blue Cross Blue
                Shield Association (May 5, 2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0003;
                Pharmaceutical Care Management Association (May 2, 2017), available
                at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0006.
                 \283\ See Aetna (May 1, 2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0005;
                Pharmaceutical Care Management Association (Mar. 27, 2017),
                available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0007; American Health Insurance Plans and Blue Cross Blue
                Shield Association (May 5, 2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0003.
                 \284\ See Pharmaceutical Care Management Association (Mar. 27,
                2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0007; American Health Insurance Plans and Blue Cross Blue
                Shield Association (May 5, 2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0003.
                ---------------------------------------------------------------------------
                 Comment: Some commenters stated that the notices and taglines
                requirements of the 2016 Rule are burdensome, but that the Department
                should consult with stakeholders to determine how to most effectively
                and efficiently communicate with LEP individuals, rather than repeal
                the requirements.
                 Response: The Department consulted with the public before and since
                issuing policy guidance to recipients on compliance with the Title VI
                obligation to take reasonable steps to ensure meaningful access to
                their programs by individuals with LEP. The Department also provided
                stakeholders with an opportunity to comment on the proposed rule during
                the public comment period.
                 Comment: The Department received comments opposing the proposed
                rule's revised Sec. 92.101, which requires covered entities to take
                reasonable steps to ensure meaningful access to its programs or
                activities by individuals with LEP. Commenters asserted that the
                proposed change is contrary to congressional intent because the
                language in Section 1557 is clear that ``an individual shall not'' be
                subject to discrimination on the prohibited grounds. Others stated that
                the proposed Sec. 92.101 inappropriately changes the Section 1557
                regulation language and shifts the focus of the regulation from an
                individual's rights to the covered entity's programs or activities,
                thus weakening meaningful access and running contrary to the text of
                Section 1557.
                 Still others recommended that--through sub-regulatory guidance--the
                Department should communicate to providers the flexibility of the LEP
                access requirement.
                 Response: This final rule fully retains all protections offered by
                Section 1557, and it does not shift any focus from an individual's
                rights to the covered entity's programs or activities. It ensures that
                covered entities do not use their programs or activities to
                discriminate on the basis of any individual's national origin, which
                includes (under Lau's disparate impact analysis) requiring those
                entities to provide reasonable access to LEP individuals.
                 Comment: The Department received comments asserting that language
                assistance is necessary for individuals with LEP to access Federally
                funded programs and activities in the healthcare system. Several
                commenters argued that adequate translation services are a civil right
                and an important tool for informing individuals with LEP of their
                healthcare rights. One commenter also expressed concern that informed
                consent is compromised when a language barrier prevents a patient from
                understanding what he or she is consenting to. Many commenters also
                said that individuals with LEP face unique challenges in healthcare
                that are mitigated by language access services, and that the proposed
                rule might weaken access by patients with LEP to quality healthcare,
                resulting in patients' avoiding or postponing the medical care they
                require out of fear of discrimination or mistreatment due to their
                national origin or the language they speak.
                 Response: The Department strongly agrees that language assistance
                is often vital for ensuring access to Federally funded programs and
                activities in the healthcare system by individuals with LEP. The
                Department believes this final rule highlights its commitment to
                ensuring that individuals with LEP receive language access services
                that are appropriate under the circumstances and consistent with
                longstanding enforcement mechanisms and guidance. Accordingly, this
                final rule clarifies throughout Sec. 92.101 that where language
                assistance services are required to be offered by a covered entity,
                they must be no-cost, timely, and accurate; that translators or
                interpreters provided in order to comply with the law must meet
                specific minimum qualifications, including ethical principles,
                confidentiality, proficiency, effective interpretation, and the ability
                to use specialized terminology as necessary in the healthcare setting;
                and that a covered entity may not require an individual with LEP to
                bring his or her own interpreter or rely on a minor child or
                accompanying adult to facilitate communication, except under limited
                exceptions. In addition, the Department expects that the cost savings
                estimated below resulting from repeal of notice and taglines
                requirements will, where applicable, free up resources that entities
                can use to provide more access to LEP individuals.
                 Comment: A commenter said that the proposed rule weakens system-
                wide standards governing access to language assistance services and
                will
                [[Page 37212]]
                disincentivize the broader system from embedding and institutionalizing
                LEP services.
                 Response: The Department knows of no evidence to support this
                assertion and considers it an improbable one, as this final rule simply
                applies the longstanding and well-known enforcement mechanisms of Title
                VI that have proven effective over time in ensuring access by
                individuals with LEP to covered programs.
                 Comment: Commenters said that it would be beneficial if the
                Department contacted providers with educational documents outlining the
                requirements under the proposed rule.
                 Response: It is not Department practice to reach out to all covered
                entities individually upon every regulatory change. At the same time,
                OCR does engage in various kinds of outreach to the regulated
                community. The proposed rule was published in the Federal Register and
                publicized on OCR's website, and this final rule will be publicized
                similarly. The Department expects its changes to reduce confusion among
                covered entities. If OCR sees evidence that this final rule's changes
                are causing any new confusion, OCR will consider issuing relevant
                guidance and education.
                 Comment: The Department received comments opposing the elimination
                of the provision requiring the Director to consider, if relevant,
                whether an entity has developed and implemented an effective written
                language access plan appropriate to its particular circumstances.
                Commenters stated that language access plans are important for
                evaluating compliance with Section 1557 and for planning efforts to
                address the needs of LEP individuals.
                 Response: The HHS LEP Guidance continues to encourage recipients to
                produce language access plans, but does not require them, and offers
                assistance to help ensure that implementation provides meaningful
                access by individuals with LEP. DOJ's LEP Guidance also does not
                require entities to produce such a plan. This final rule brings the
                Department's LEP regulations into closer conformity with the DOJ
                guidance, while Departmental guidance continues to encourage covered
                entities to go beyond minimum regulatory requirements.
                 Comment: One commenter argued that the justifications related to
                costs and resource availability do not supersede the right to
                meaningful access for individuals with LEP. Another commenter objected
                to cost's being the primary determinant for compliance with the
                proposed rule.
                 Response: Cost is not the primary factor in the four-factor
                analysis; no single factor is determinative. The four-factor analysis
                does not supersede the right to meaningful access but rather helps
                determine when an entity has taken reasonable steps to secure that
                right.
                 Comment: Some commenters believe the four-factor analysis under
                Sec. 92.101(b) is too broad, lacks clarity, does not ensure that
                translation and other language services are available under important
                medical circumstances, may require recipients to provide unnecessarily
                expensive services, and/or weakens recipient language access
                obligations to serve persons who speak infrequently encountered
                languages. Others said that the proposed rule does not require a
                medical provider to make any effort to secure translation services when
                a patient faces a dire medical condition. Others supported the proposed
                rule's changes, indicating they would provide more flexibility for
                covered entities while ensuring that LEP persons have meaningful access
                to services. Some indicated that covered entities should not be
                required to provide expensive forms of language assistance, such as
                video remote interpreting services.
                 Response: The Department agrees with commenters who state that the
                four-factor analysis is an appropriate way to allow flexibility for
                covered entities while ensuring meaningful access for LEP individuals.
                As to the specific hypothetical situations described by commenters, OCR
                will evaluate such situations as they are presented to OCR on a case-
                by-case basis. The fact-dependent nature of Title VI analysis makes it
                impossible to make pronouncements on such situations without all the
                relevant facts.
                 Comment: Some commenters requested that this final rule stipulate
                that health insurance plans are in compliance with the four-factor test
                if they incorporate either State LEP requirements or items 4-7 of the
                National Standards for Culturally and Linguistically Appropriate
                Services (CLAS).
                 Response: The ACA instructs the Department to apply to Section 1557
                the enforcement mechanisms available under Title VI, which include
                mechanisms for enforcing language access cases. This final rule relies
                on longstanding Federal practice in enforcing Title VI; it is far from
                clear that the Department would have statutory authority to enforce the
                CLAS standards or State LEP requirements instead. Moreover, recipients
                that provide language assistance in accordance with CLAS standards and
                State LEP requirements may still be utilizing other methods of
                administration that violate the final rule.
                 Comment: Some commenters suggested that administrative burden would
                be relieved by adopting uniform language access policies with other
                components in the Department like CMS, arguing that it would improve
                patient experiences and reduce errors.
                 Response: Because CMS program regulations are often implemented
                under different statutes than are civil rights regulations, and because
                LEP standards under Title VI have been subject to longstanding
                standards under DOJ and HHS guidance, the Department does not believe
                it is necessary at this time to adopt uniform language access standards
                across these different regulations. This final rule addresses
                regulations under Section 1557 and the civil rights statutes it
                incorporates.
                 Comment: Some commenters argued the proposed rule weakens the
                qualifications for language service providers by eliminating the words
                ``qualified'' and ``above average familiarity with'' from the proposed
                description of language interpreters and translators.
                 Response: This final rule does not weaken any qualifications for
                language service providers. It continues to use the term ``qualified''
                six times in its regulatory text to describe ``interpreters,''
                ``translators,'' or ``staff'' as relevant. As stated in the 2019 NPRM,
                this final rule eliminates the term ``qualified'' from the 2016 Rule
                only where it was redundant and clearly implied by the context--namely,
                a list of the translator's/interpreter's mandatory qualifications, a
                list that remains unchanged from the 2016 Rule.\285\ And the 2016 Rule
                expressly declined to include any reference to ``above average
                familiarity.'' \286\
                ---------------------------------------------------------------------------
                 \285\ 84 FR 27860, 27866.
                 \286\ 81 FR 31390-91.
                ---------------------------------------------------------------------------
                 Comment: A commenter asserted that the proposed rule will adversely
                affect the patient-provider dialogue in addiction treatment programs,
                and underscored the importance of transparency in discussions about
                substance use history.
                 Response: The Department is not aware of any evidence to
                demonstrate this assertion, and believes that relying on the
                Department's underlying regulations and guidance will not result in
                such adverse effects.
                 Comment: Commenters expressed concern over the Department's
                proposal to remove requirements on video
                [[Page 37213]]
                interpreting quality standards as it relates to using video remote
                interpreting (VRI) services for LEP individuals or spoken language
                interpreting. Many commenters noted that most VRI services are done on
                the same equipment and through the same network and bandwidth for both
                spoken language and sign language, and that if these standards are
                removed for spoken language interpreters, there will be an unintended
                consequence of lower-quality VRI services for deaf and hard of hearing
                individuals. Other commenters noted that while they appreciated the
                incorporation of the ADA's definition of VRI, they opposed the removal
                of the technical and training requirements for the use of VRI for
                spoken language interpretation.
                 Some commenters recommended that all covered healthcare entities
                prioritize the use of on-site sign language interpreters, limit usage
                of VRI to specific situations, and maintain either a directory of local
                interpreters available for on-site work or a contract with an
                interpreter service provider to secure on-site interpreters when
                needed. Commenters offered detailed suggestions for regulations to
                limit VRI usage.
                 Response: In place of blanket requirements for VRI standards, this
                final rule adopts the four-factor analysis regarding access for LEP
                individuals, which will help covered entities balance competing
                considerations related to VRI quality standards. Where high-quality VRI
                is necessary to provide meaningful access to LEP persons, high-quality
                VRI will be required just as it was under the 2016 Rule. Furthermore,
                as is made clear in the next subsection (on proposed Sec. 92.102),
                this final rule continues to hold covered entities to the ADA Title II
                standards for video interpretive services where these are needed for
                effective communication for deaf or hard of hearing individuals.
                 The Department requested comment on whether HHS's Title VI
                regulations at 45 CFR part 80 should be amended to address the Lau v.
                Nichols \287\ precedent.
                ---------------------------------------------------------------------------
                 \287\ Lau v. Nichols, 414 U.S. 563 (1974).
                ---------------------------------------------------------------------------
                 Comment: A commenter stated that the Department's regulations
                implementing Title VI do not need to be amended to address Lau v.
                Nichols as HHS and DOJ have followed this Supreme Court precedent for
                decades.
                 Response: The Department agrees and will continue to enforce Title
                VI consistent with Federal law.
                 In reviewing Sec. 92.101 and public comments, the Department
                observed that the proposed rule inadvertently omitted the word ``or''
                from the end of paragraph (b)(4)(ii)(A), concerning exceptions to the
                prohibition on using an adult accompanying an individual with LEP to
                interpret or facilitate communication. The ``or'' had been included in
                the parallel provision of the 2016 Rule at Sec. 92.201(e)(2)(i); in
                the preamble to the proposed rule, the Department explained that it
                would apply those exceptions ``[l]ike the current rule'' (meaning as in
                Sec. 92.201(e) of the 2016 Rule). 84 FR at 27866. To correct this, the
                Department finalizes Sec. 92.101 with a technical change to insert
                ``or'' at the end of paragraph (b)(4)(ii)(A).
                (2) Effective Communication for Individuals With Disabilities (45 CFR
                92.102)
                 The Department proposed to retain the 2016 Rule's provisions on
                effective communication for individuals with disabilities. 84 FR at
                27866-67.
                 Comment: A commenter suggested that each Section 1557 covered
                entity should simply comply with the standards that apply to each
                entity under the ADA, in order to reduce burden, confusion, and
                complexity.
                 Response: As a general matter, the Department does not view a
                covered entity's compliance with other Federal regulations, adopted
                with different requirements and for different purposes, as
                determinative of a covered entity's compliance with Section 1557.
                 Comment: The Department received comments expressing concern that
                the proposed rule would cause major harm to people with disabilities,
                affecting their access to effective healthcare, especially for those
                individuals in underserved and rural communities. Commenters suggested
                that because the current rule is working as it was intended, there is
                not sufficient reason to reopen it. Commenters argued that the ability
                to effectively communicate includes the individual patient as well as
                the patient's family/caregivers, and that the inability to effectively
                communicate can have significant adverse effects on an individual's
                access to healthcare. Other commenters expressed support for retaining
                the provisions of 45 CFR 92.202 (redesignated Sec. 92.102), regarding
                effective communication for individuals with disabilities. Commenters
                noted that effective communication is a critical component to accessing
                and receiving healthcare and that often covered entities rely on
                communication methods that are the preference of the covered entity
                rather than the choice of the individual with a disability. Commenters
                stated that giving primary consideration to the choice of aid or
                service requested by an individual with a disability helps to ensure
                effective communication and equal opportunity in the healthcare
                setting. Commenters commended HHS for holding all recipients of Federal
                financial assistance from HHS to the higher ADA Title II standards.
                 Response: Access to care continues to be a critical concern for the
                Department, and access to care clearly requires effective
                communication. The Department does not believe this final rule will
                impede individuals' access to care, but that instead it will assist
                individuals in understanding a covered entity's legal obligations and
                their own rights under Section 1557. In addition, the rule will assist
                the Department in complying with the mandates of Congress and further
                substantive compliance. Finally, because this final rule will lift
                unnecessary regulatory burdens on providers, the Department hopes that
                it will increase access to care, including in underserved and rural
                communities.
                 Comment: Commenters noted that the current regulation's language
                tracks the statutory text of Title I and Title III of the ADA and the
                regulatory language of Title II of the ADA, all of which protect
                against discrimination based on association or relationship with a
                person with a disability. They said that the proposed rule's
                elimination of the 2016 Rule's prohibition on associational
                discrimination will therefore create bewilderment concerning providers'
                responsibilities and individuals' rights. Commenters argued that
                deleting the language will create uncertainty and confusion regarding
                the responsibilities of providers and the rights of persons who
                experience discrimination, and inconsistencies with other regulatory
                requirements that entities are subject to, including the ADA and
                Section 504.
                 Response: As stated above, protections against discrimination on
                the basis of association will be available under this final rule to the
                extent that they are available under the incorporated civil rights
                statutes and their implementing regulations. The Department notes that
                courts have often relied on ADA statutory provisions in their handling
                of Section 504 claims.\288\
                ---------------------------------------------------------------------------
                 \288\ See Memorandum on Coordination of Federal Agencies'
                Implementation of Title II of the Americans with Disabilities Act
                and Section 504 of the Rehabilitation Act, Acting Assistant Attorney
                General (April 24, 2018); see, e.g., Theriault v. Flynn, 162 F.3d
                46, 48 n.3 (1st Cir. 1998); Henrietta D. v. Bloomberg, 331 F.3d
                261,272 (2d Cir. 2003); Helen L. v. DiDario, 46 F.3d 325, 330 n.7
                (3rd Cir. 1995); Baird ex rel. Baird v. Rose, 192 F.3d 462, 468 (4th
                Cir. 1999); Delano-Pyle v. Victoria Cty., Tex., 302 F.3d 567, 574
                (5th Cir. 2002); McPherson v. Michigan High School Athletic Ass 'n,
                Inc., 119 F.3d 453, 459-60 (6th Cir. 1997); Gorman v. Bartch, 152
                F.3d 907, 912 (8th Cir. 1998); Zukle v. Regents of Univ. of Cal.,
                166 F.3d 1041, 1045 n.11 (9th Cir. 1999); Cohan ex rel. Bass v. N.M.
                Dept. of Health, 646 F.3d 717, 725-26 (10th Cir. 2011); Bircoll v.
                Miami-Dade Cty., 480 F.3d 1072, 1088 n.21 (11th Cir. 2007).
                ---------------------------------------------------------------------------
                [[Page 37214]]
                 Comment: Several commenters objected that the definition of
                auxiliary aids and services at proposed Sec. 92.102(b)(1) excludes the
                term ``Qualified'' before ``Interpreters'' in subsection (i) and before
                ``Readers'' in subsection (ii), despite being part of the ADA
                definition at 28 CFR 35.104. Some Commenters strongly encouraged the
                Department to incorporate the ADA definition of ``Qualified Reader'' as
                follows: ``Qualified reader means a person who is able to read
                effectively, accurately, and impartially using any necessary
                specialized vocabulary.'' \289\
                ---------------------------------------------------------------------------
                 \289\ 28 CFR 35.104.
                ---------------------------------------------------------------------------
                 Response: As stated above regarding Sec. 92.101(a), this final
                rule eliminates the term ``qualified'' from the 2016 Rule only where it
                was redundant and clearly implied by the context. In this case,
                subsection (b)(2) clearly lists the mandatory qualifications for
                interpreters required under subsection (b)(1), and it adopts that list
                from the ADA definition at 28 CFR 35.104 and Sec. 36.303(f). It would
                therefore be redundant to describe those interpreters in subsection
                (b)(1) as ``qualified.'' No definition of ``Qualified Reader'' appears
                in the 2016 Rule, so the Department is making no change in that regard.
                But the Department interprets this subsection naturally as requiring
                qualifications for readers that are similar to the expressly stated
                qualifications for interpreters.
                 Comment: Commenters argued that although the proposed rule claims
                to incorporate the definition of auxiliary aids and services from the
                regulations implementing Title II of the ADA, the rule as proposed
                changes the definition of auxiliary aids and services, omitting
                ``acquisition or modification of equipment and devices; and other
                similar services and actions'' from the list of examples of aids and
                services. Commenters noted that this proposed change will confuse
                providers and people with disabilities and will lead both groups to
                assume the list in the proposed rule is exhaustive. Commenters opposed
                these deletions and requested that the Department retain the definition
                of auxiliary aids and services from the 2016 Rule.
                 Response: The Department's definition of auxiliary aids and
                services is consistent with, even if not identical to, that of the ADA.
                The Department does not deem it necessary to incorporate all of the
                ADA's examples, as neither the ADA's list nor this final rule's list
                claims to be exhaustive.
                 Comment: Some commenters expressed concern regarding the narrowing
                of the ``free of charge'' and ``timely manner'' provision at proposed
                Sec. 92.102(b)(2). Commenters noted that the 2016 Rule's language is
                consistent with existing ADA Title II regulations, which provide that
                covered entities may not place a surcharge on a particular individual
                or group of individuals with a disability to cover the costs of the
                provision of auxiliary aids or program accessibility. Commenters
                asserted that the proposed Sec. 92.102(b)(2) significantly narrows
                this provision by stating that ``interpreting service'' shall be
                provided to individuals free of charge and in a timely manner. These
                commenters strongly opposed this change and encourage the Department to
                replace the words ``interpreting service'' with ``auxiliary aids and
                services'' to be consistent with the ADA and to prevent unnecessary
                confusion over the requirement.
                 Response: Like Sec. 92.202 of the 2016 Rule, which it replaces,
                Sec. 92.102 of this final rule continues to incorporate the ADA Title
                II regulations at 28 CFR 35.160-164. The new section also includes new
                language on the qualifications for interpreters, which is where the
                term ``free of charge'' now appears; the term did not appear in Sec.
                92.202 of the 2016 Rule. To the extent that auxiliary aids must be
                provided free of charge under the 2016 Rule, they must still be
                provided free of charge under this final rule.
                 Comment: One commenter asked that the phrase ``in a timely manner''
                as used in Section 92.102(b)(2) of the proposed rule be clarified with
                clear guidance as to what can and cannot be considered ``in a timely
                manner.''
                 Response: Application of the term ``in a timely manner'' requires a
                nuanced analysis that is fact-dependent. Its meaning can be understood
                from the long history of enforcement of Section 504 and the ADA in the
                courts and administratively.
                 Comment: Some commenters supported an exemption from the auxiliary
                aids and services requirement for covered entities with fewer than 15
                employees, stating that it would help alleviate financial and
                administrative burden for smaller physician group practices that may
                already have limited resources. Others said that in some areas of the
                country, especially in small and rural communities, such an exemption
                could effectively bar access to many providers. Commenters said that
                any such exemption would be inconsistent with the standard present in
                Title II \290\ and Title III \291\ of the ADA, which require the same
                businesses to provide auxiliary aids and services to individuals with
                disabilities where necessary to ensure effective communication,
                regardless of the number of employees. They said that the existence of
                two competing regulatory standards will confuse small covered entities
                as to which standard they should follow. Several commenters noted that
                although a small economic burden may be placed on small businesses that
                have to comply with this requirement, there are programs that provide
                tax benefits and funding for the provision of reasonable
                accommodations, significantly reducing the burden placed on these
                entities.\292\ Some commenters noted that because Titles II and III of
                the ADA already provide for sufficient mechanisms for providers to
                request exemptions based on a fundamental alteration in the nature of
                goods and services provided and undue burden, no additional exemption
                is needed through Section 1557.
                ---------------------------------------------------------------------------
                 \290\ 28 CFR 35.104.
                 \291\ See 42 U.S.C. 12182(b)(A)(iii) (under Title III, privately
                operated public accommodations regardless of their size are
                obligated to provide appropriate auxiliary aids and services, when
                necessary to ensure effective communication with individuals with
                disabilities, unless the entity can demonstrate that taking such
                steps would fundamentally alter the nature of their programs,
                services or activities, or would result in undue financial and
                administrative burdens).
                 \292\ Commenters cited U.S. Department of Justice American with
                Disabilities Act Update: A Primer for Small Business. (2010).
                Retrieved from https://www.ada.gov/regs2010/smallbusiness/smallbusprimer2010.htm; Internal Revenue Service. (n.d.); Form 8826,
                Disabled Access Credit. Retrieved from https://www.irs.gov/forms-pubs/about-form-8826.
                ---------------------------------------------------------------------------
                 Response: The Department believes that in the interest of
                uniformity and consistent administration of the law, all employers that
                receive Federal financial assistance from HHS, regardless of their
                size, should be held to the auxiliary aids and services requirement.
                The Department recognizes the importance of individuals being able to
                effectively communicate with their healthcare providers and is aware
                that the inability to effectively communicate can have significant
                adverse effects on individuals' access to effective healthcare. The
                Department's decision to require all entities, regardless of size, to
                provide auxiliary aids and services is consistent with OCR's policy for
                almost two decades,\293\ so covered entities will
                [[Page 37215]]
                be familiar with the obligations being imposed. Title II and Title III
                of the ADA already require public and private healthcare entities to
                provide auxiliary aids and services regardless of the number of
                employees. Both Titles state that an entity is not required to take any
                action that it can demonstrate would result in a fundamental alteration
                in the nature of a service, program, or activity or in undue financial
                and administrative burdens, and Sec. 92.102 incorporates both of those
                limitations through its incorporation of the ADA Title II regulations
                at 28 CFR 35.160-164. Therefore, the Department finds it appropriate
                not to adopt an exemption from the auxiliary aids and services
                requirement for covered entities with fewer than 15 employees.
                ---------------------------------------------------------------------------
                 \293\ See Notice of Exercise of Authority Under 45 CFR
                84.52(d)(2) Regarding Recipients With Fewer Than Fifteen Employees,
                65 FR 79368 (Dec. 19, 2000).
                ---------------------------------------------------------------------------
                 Comment: Commenters said that the ``primary consideration''
                standard has evolved such that patients will demand that a particular
                translator or interpreter be used, regardless of the expense. These
                commenters argued that when patients demand use of a certain company or
                specific commercial service, this creates additional unnecessary costs
                for the covered entity. One commenter stated that Title III of the ADA
                should be the standard that applies to private businesses covered by
                Section 1557 regarding effective communication for individuals with
                disabilities. The commenter asserted that the Title II primary
                consideration standard is not appropriate for use in a clinical setting
                and that treating clinicians or the entities themselves are in the best
                position to determine the types of services necessary to address the
                communication needs of their patients. The commenter argued that
                applying Title II standards to private entities has created significant
                confusion for medical group practices accustomed to following
                longstanding Title III rules.
                 Response: Since the 2015 NPRM, the Department has held that it is
                appropriate, as a condition of receipt of Federal financial assistance
                from HHS, to hold all recipients to the higher 2010 ADA Title II
                standards regarding effective communication with individuals with
                disabilities.\294\ The Department does not consider the commenters'
                concerns to be a sufficient reason to change this policy. Section
                92.102 of this final rule seeks to avoid confusion by providing covered
                entities with clear, specific guidance to help them understand their
                rights and responsibilities regarding effective communication with
                individuals with disabilities. As mentioned above, it also incorporates
                the ``undue burden'' and ``fundamental alteration'' limitations of ADA
                Title II, in order to avoid excessively burdening covered entities.
                ---------------------------------------------------------------------------
                 \294\ 80 FR 54186.
                ---------------------------------------------------------------------------
                (3) Accessibility Standards for Buildings and Facilities (45 CFR
                92.103)
                 The Department proposed at Sec. 92.103(a) to retain the 2016
                Rule's requirement that new construction or alteration of buildings or
                facilities subject to Section 1557 must comply with the 2010 ADA
                Standards for Accessible Design by January 18, 2018, and to retain the
                2016 Rule's allowance of departures from the 2010 ADA standards where
                other methods are permitted that provide substantially equivalent or
                greater access to and usability of the building. 84 FR at 27867. The
                Department proposed at Sec. 92.103(b) to create a safe harbor for new
                construction or alteration of buildings or facilities subject to
                Section 1557, allowing existing facilities which were only required to
                be compliant with the Uniform Federal Accessibility Standards
                (``UFAS''), the 1991 ADA Standards, or the 2010 ADA Standards as of
                July 18, 2016, to be deemed compliant, unless there is new construction
                or alteration after January 18, 2018. Finally, the Department proposed
                at 92.103(c) to identify the three applicable building and facility
                detailed technical accessibility standards by cross-reference to their
                underlying regulations, instead of listing them in a separate
                definitions section.
                 Upon further consideration of this language and the public
                comments, the Department observed a potential ambiguity in Sec. 92.203
                of the 2016 Rule. The rule distinguished between construction or
                alteration commenced ``on or after July 18, 2016'' in the first
                sentence of Sec. 92.203(a), those commenced ``on or before July 18,
                2016'' in the first sentence of Sec. 92.203(b), and those commenced
                ``before July 18, 2016'' in the last sentence of Sec. 92.203(b). This
                potentially left it unclear how the rule would apply to construction or
                alteration commenced on July 18, 2016. To avoid confusion, the
                Department is finalizing Sec. 92.103 with a technical change, by
                deleting the phrase ``on or'' from the first sentence of Sec.
                92.103(a), and adding ``on or'' before the word ``before'' in the last
                sentence of Sec. 92.103(b). This resolves the ambiguity while
                providing leeway to activities commenced on July 18, 2016 where it was
                not clear how the 2016 Rule applied.
                 Comment: Commenters supported the proposal to continue to apply the
                2010 ADA Standards' definition of ``public building or facility'' to
                all entities covered under Section 1557, by retaining the provisions of
                45 CFR 92.203 (redesignated Sec. 92.103) regarding accessibility
                standards for buildings and facilities. Commenters opposed any type of
                additional exemption from the requirements concerning multistory
                building elevators \295\ and Text Telephone (TTY) requirements.\296\
                Some commenters strongly opposed the proposed rule's incorporation of
                the private entity TTY standard from the 2010 ADA Standards, and
                requested the retention of the existing TTY ratios, and the adoption of
                stringent Real-Time Text (RTT) ratios. Others noted that lack of
                accessible medical equipment presents barriers to effective healthcare
                for people with impaired mobility or strength and other disabilities,
                and they requested that the Department require healthcare facilities to
                follow the 2017 Architectural and Transportation Barriers Compliance
                Board (U.S. Access Board) Standards for Accessible Medical Diagnostic
                Equipment.\297\
                ---------------------------------------------------------------------------
                 \295\ See 42 U.S.C. 12101 et seq. Exception 1 of section 206.2.3
                of the 2010 ADA standards exempts multistory buildings besides the
                professional office of a healthcare provider owned by private
                entities from the requirement to provide an elevator to facilitate
                an accessible route throughout the building. This exemption does not
                apply to public entities.
                 \296\ The 2010 ADA Standards also specifies TTY requirements for
                public buildings different from private buildings. Compare ADA 2010
                Standard 217.4.3.1 (public buildings) with ADA 2010 Standard
                217.4.3.2 (private buildings).
                 \297\ See Information and Communication Technology (ICT)
                Standards and Guidelines, 82 FR 5790 (Jan. 18, 2017) (final rule);
                83 FR 2912 (Jan. 22, 2018) (technical edits).
                ---------------------------------------------------------------------------
                 Response: The Department believes that, because the great majority
                of entities covered by the 2016 Rule have already been subject to the
                2010 ADA Standards, an approach that emphasizes uniform application of
                the 2010 Standards will promote conformity with pre-existing civil
                rights statutes while enabling greater consistency among implementing
                agencies. Any significant reevaluation of those standards or adoption
                of new standards is beyond the scope of this regulation. In the case of
                adopting new standards, the Department also declines to make such a
                significant regulatory change without the benefit of notice and public
                comment.
                (4) Accessibility of Information and Communication Technology (45 CFR
                92.104)
                 The Department proposed to retain the 2016 Rule's provisions on
                accessibility of information and communication technology for
                individuals with disabilities. 84 FR at 27867. The Department also
                proposed at 92.104(c) to update the 2016 Rule's
                [[Page 37216]]
                outdated term ``electronic and information technology'' with the term
                ``information and communication technology,'' as defined in the U.S.
                Access Board regulations. 84 FR at 27871.
                 Comment: Commenters expressed concern with the Department's
                proposed change to the definition of ``information and communication
                technology'' (ICT), in proposed Sec. 92.104(c). Commenters noted that
                the critical phrase ``but are not limited to'' has been removed from
                the definition the Department claims to have incorporated from the U.S.
                Access Board's definition for ICT.\298\ The commenters argue that due
                to the difficulty in predicting what technologies will be in place
                moving forward, it is important to maintain flexibility and ensure that
                the regulation keep pace with emerging technologies.
                ---------------------------------------------------------------------------
                 \298\ See 36 CFR app. A Sec. 1194 (2011) (defining ICT as
                ``Information technology and other equipment, systems, technologies,
                or processes, for which the principal function is the creation,
                manipulation, storage, display, receipt, or transmission of
                electronic data and information, as well as any associated content.
                Examples of ICT include but are not limited to: Computers and
                peripheral equipment; information kiosks and transaction machines;
                telecommunications equipment; customer premises equipment;
                multifunction office machines; software; applications; websites;
                videos; and electronic documents.'').
                ---------------------------------------------------------------------------
                 Response: The list of auxiliary aids was not intended as an all-
                inclusive or exhaustive catalogue of possible or available auxiliary
                aids or services--nor could it possibly be, given the new devices that
                will become available with emerging technology. The Department omitted
                the phrase ``but are not limited to'' merely in order to avoid
                unnecessary legal jargon. The plain meaning of ``include'' already
                encompasses ``but are not limited to,'' as it signifies that the listed
                items are only parts of a larger whole.
                 Comment: One commenter requested that the Department require
                recipients of Federal financial assistance to ensure that health
                programs or activities provided through their websites comply with the
                requirements of Title III, rather than Title II, of the ADA, if the
                recipient is otherwise covered by Title III. The commenter argued that
                the burden placed on small practices by having to comply with both
                Title II and Title III would likely outweigh any benefit to individuals
                who require accessible technology.
                 Response: The Department believes that this comment understates the
                benefit of the Title II standards to individuals who require accessible
                technology. Effective communication is a critical component for
                individuals to be able to access and receive healthcare, and this
                includes being able to access covered entities' websites. The
                Department believes that in the interest of uniformity of access for
                individuals with disabilities, all entities that receive Federal
                financial assistance from HHS should be held to the higher information
                and communication technology standards of Title II. The ADA does not
                exempt small providers from this requirement, although Sec. 92.104
                does incorporate the ADA's ``undue financial and administrative
                burden'' and ``fundamental alteration'' exemptions in order to protect
                covered entities from excessive burdens.
                 Comment: Some commenters stated that the Department should cross-
                reference Section 508 in its proposed Sec. 92.104. The commenters
                noted that although the proposed rule tracks the concepts of the
                Section 508 regulations, it does not include the appropriate cross-
                reference, which will cause confusion if and when the Section 508
                regulations are updated.
                 Response: If and when Section 508 regulations are updated, the
                Department will evaluate whether or not to update Sec. 92.104
                accordingly. Because this final rule does not incorporate Section 508
                regulations but merely tracks them, the Department believes that a
                cross reference could cause unnecessary confusion if and when Section
                508 regulations are updated or changed.
                (5) Requirement To Make Reasonable Modifications (45 CFR 92.105)
                 The Department proposed at Sec. 92.105 to retain the 2016 Rule's
                requirement that covered entities make reasonable modifications to
                policies, practices, or procedures when necessary to avoid
                discrimination on the basis of disability, unless the covered entity
                can demonstrate that the modification would fundamentally alter the
                health program or activity. 84 FR at 27868. The Department sought
                comment on whether to include an exemption for ``undue hardship.'' Id.
                 Comment: Commenters strongly opposed an exemption for undue
                hardship in regard to the requirement that covered entities make
                reasonable modifications to policies, practices, or procedures when
                necessary, to avoid discrimination on the basis of disability, except
                if the modification would fundamentally alter the nature of the health
                program or activity. Commenters pointed out that the current
                regulations track Title II of the ADA. Commenters stated that Title III
                does not absolve a covered entity from providing all forms of auxiliary
                aids if providing a particular auxiliary aid would result in undue
                burden, and that a provider has an obligation to find an alternative
                auxiliary aid in such cases. Commenters noted that because Title II and
                III of the ADA already provide mechanisms for providers to request
                exemptions based on an undue burden, no additional exemption is needed.
                Commenters stated that the substitute language proposed is from
                regulations related to employment and ill-fitting and inappropriate in
                a healthcare context. Commenters requested that if an exemption for
                undue hardship is provided, it should mirror the undue burden provision
                of the ADA, to ensure the two Federal laws are in sync and do not
                conflict with one another and lead to confusion.
                 Response: The Department agrees with commenters who ask that the
                regulations continue tracking Title II of the ADA, whose requirement
                for reasonable modifications includes a fundamental alteration
                exemption but no undue hardship exemption. The Department believes that
                this position helps promote continued consistency with pre-existing
                civil rights statutes. The reasonable modification analysis already
                applies to many entities subject to Section 1557 and is well-defined by
                regulation and decades of case law. Continuing to apply the
                ``reasonable modification'' analysis to Section 1557 promotes
                consistency with pre-existing civil rights law and is consistent with
                the U.S. Supreme Court's decision interpreting Section 504 in Alexander
                v. Choate, 469 U.S. 287 (1985), Title II of the ADA, and OCR's
                longstanding interpretation of Section 504.
                 Comment: Commenters objected to substituting the Title II
                reasonable modification language with language stating that covered
                entities ``shall make reasonable accommodation to the known physical or
                mental limitations of an otherwise qualified'' individual with a
                disability. Further, a commenter argued that use of the term ``known,''
                outside the employment context, would suggest an overly narrow
                interpretation of the scope of Section 1557 and introduce an
                unnecessarily burdensome and intrusive process into the healthcare
                context. Commenters expressed concern that importing the ``known
                physical or mental limitation'' language would suggest to covered
                entities that their obligations are limited, and would create an undue
                focus on the measures that entities must take in response to requests
                for modifications.
                 Response: The Department shares the concern that introduction of
                the phrase ``known physical or mental limitations'' may cause covered
                entities to introduce
                [[Page 37217]]
                exceedingly burdensome and intrusive processes into the healthcare
                context. In contrast, the concept of reasonable modification taken from
                Title II has long applied to a wide range of entities covered by
                Section 1557, making such entities familiar with the requirements
                imposed, and is well-defined by regulation and decades of case law. The
                Department believes that continuing to apply the reasonable
                modification analysis to Section 1557 will help promote consistency
                with pre-existing civil rights statutes.
                 Comment: Several commenters noted that the citation for the
                proposed reasonable modification language the Department claims
                conforms to the Department of Justice's Section 504 coordinating
                regulations is to a non-existent portion of the Code of Federal
                Regulations. These commenters argue that these incorrect citations make
                it impossible for the public to analyze the context or case law of the
                proposed imported language and that such uncertainty makes it
                impossible for the public to reliably know what the Department is
                proposing.
                 Response: The Department thanks these commenters for bringing this
                citing error to its attention. For clarity, the Department notes that
                it intended to cite to 28 CFR 42.511, not Sec. 92.205.\299\ But for
                the reasons stated above, the Department has determined that it should
                retain the current Title II reasonable modification language.
                ---------------------------------------------------------------------------
                 \299\ See 84 FR 27868 (citing to 28 CFR 92.205).
                ---------------------------------------------------------------------------
                 Comment: Some commenters recommended that the rule include the
                addition of examples of programmatic modifications that are often
                needed by those with disabilities, such as the modification of wait
                times, office hours, and other business practices that can make
                accessibility to healthcare for people with disabilities difficult.
                 Response: The Department declines to enshrine a list of examples of
                ``programmatic modifications'' needed by those with disabilities.
                Because this final rule applies to a diverse range of covered entities,
                codifying examples would not provide meaningful guidance to the full
                spectrum of regulated covered entities. The Department believes that
                each covered entity ought to determine for itself which programmatic
                modifications with respect to its health programs and activities should
                be undertaken to avoid discrimination on the basis of disability,
                subject to enforcement by OCR in case of a complaint.
                 Comment: Commenters found inappropriate the Department's requesting
                comment on whether it has struck the appropriate balance in proposed
                Sec. Sec. 92.102 through 92.105 with respect to Section 504 rights and
                obligations imposed on the regulated community, as such a balancing
                exercise is not called for by the statute and inserts inappropriate
                regulatory subtlety.
                 Response: In any rulemaking, addressing obstacles that impede
                individuals from exercising their rights should be balanced against
                potentially unnecessary obligations that may be imposed on the
                regulated community. Agencies engage in this type of balancing in order
                to ensure that the interests and issues of both individuals and the
                regulated community are fairly considered during the rulemaking
                process, helping to minimize the burden associated with Federal
                regulations.
                 Comment: A commenter said that in order to promote clarity and
                affirm that VRI quality standards apply in any remote interpreting
                situation that may arise for a person with a disability, Sec. 92.101
                of the proposed rule ought to cross-reference the VRI quality standards
                in Sec. 92.102.
                 Response: Section 92.102 covers individuals with disabilities.
                Sec. 92.101 covers individuals with LEP status, which is not a
                disability. Individuals with disabilities have different needs than LEP
                individuals, and the current regulatory text reflects that difference.
                If an LEP individual happens also to have a disability, then the VRI
                quality standards of Sec. 92.102 will apply to him/her.
                (6) Summary of Regulatory Changes
                 The Department finalizes the proposed sections Sec. 92.101 through
                92.105 without change, except that technical changes are made to add
                the word ``or'' at the end of Sec. 92.101(b)(4)(ii)(A), to delete the
                phrase ``on or'' from the first sentence of Sec. 92.103(a), and to add
                the phrase ``on or'' before the word ``before'' in the last sentence of
                Sec. 92.103(b).
                D. Title IX Regulations
                 The Department proposed to conform its Title IX regulations to
                current statutory provisions.
                (1) Nomenclature, Rules of Appearance, Effective Date Modifications to
                Rules at 45 CFR 86.31 and 86.71
                 The Department proposed to make a nomenclature change to the Title
                IX regulation by replacing ``United States Commissioner of Education''
                with the official's current title, ``Secretary of Education.'' \300\
                The Department also proposed to update the Title IX regulation's
                statutory citations to include the full current text of Title IX as
                amended by the CRRA.
                ---------------------------------------------------------------------------
                 \300\ See 45 CFR 86.2(n).
                ---------------------------------------------------------------------------
                 The Department also proposed to repeal a prohibition on
                discrimination on the basis of ``rules of appearance'' in 45 CFR 86.31.
                The Department further proposed to update the enforcement section in
                the Department's Title IX regulation at 45 CFR 86.71, which currently
                discusses only enforcement procedures for the interim period before the
                issuance of the consolidated Title IX regulation. This final rule
                applies language from the Title IX regulation, which incorporates Title
                VI procedures.
                 Comment: The Department received comments indicating that the rules
                of appearance prohibition is well supported by Title IX and that HHS
                provides no basis for removing the prohibition.
                 Response: This final rule's NPRM explained that currently, the
                Department is the only Federal agency with Title IX regulatory language
                prohibiting discrimination ``against any person in the application of
                any rules of appearance.'' \301\ The phrase ``rules of appearance''
                does not appear in Title IX and was never defined in any agency's Title
                IX regulations. Consequently, the Department believes the phrase may
                cause confusion in the public about Title IX's coverage and compliance
                responsibilities, and has already led to at least one lawsuit. Because
                this language is not in the current regulations of any other agencies,
                this final rule limits the potential for conflicting and inequitable
                Federal agency enforcement of Title IX with respect to ``rules of
                appearance.''
                ---------------------------------------------------------------------------
                 \301\ See, e.g., 47 FR 32527 (July 28, 1982) (Department of
                Education Title IX regulation); 65 FR 52858 (Aug. 30, 2000) (common
                rule adopted by twenty agencies), 66 FR 4627 (Feb. 20, 2001) (common
                rule adopted by Department of Energy); 82 FR 46656 (Oct. 6, 2017)
                (U.S. Department of Agriculture adopting common rule).
                ---------------------------------------------------------------------------
                (2) Abortion Neutrality of 20 U.S.C. 1688 in 45 CFR 86.2 and 86.18
                 The Department also proposed to modify its Title IX regulations, at
                45 CFR 86.18, to reflect the statutory text Congress enacted in Title
                IX. This text includes what some commenters referred to as the Danforth
                Amendment, 20 U.S.C. 1688, which states that Title IX is not to be
                construed to force or require any individual or hospital or any other
                institution, program, or activity receiving Federal funds to perform or
                pay for an abortion; to require or prohibit any person, or public or
                private entity, to provide or pay for any benefit or service, including
                the use
                [[Page 37218]]
                of facilities, related to an abortion; or to permit a penalty to be
                imposed on any person or individual because such person or individual
                is seeking or has received any benefit or service related to a legal
                abortion.\302\ The Department also proposed to add a provision, similar
                to the provision of the Section 1557 regulation discussed above under
                ``relation to other laws,'' ensuring that its Title IX regulation would
                be construed consistently with various religious freedom and conscience
                statutes, including the explicit religious exemptions in the text of
                Title IX itself.
                ---------------------------------------------------------------------------
                 \302\ See Public Law 100-259, 102 Stat. 28, sec. 8 (Mar. 22,
                1988) (codified at 20 U.S.C. 1688).
                ---------------------------------------------------------------------------
                 Comment: One commenter stated that adding Title IX's abortion
                neutrality language in the Department's Title IX regulations would be a
                violation of the plain language of the definition of sex discrimination
                in the regulations, which includes termination of pregnancy. Others
                noted that discrimination based on termination of pregnancy has been
                recognized by courts as sex discrimination and therefore argued that
                the proposed rule is contrary to civil rights laws and constitutional
                principles. Some noted that Title IX itself expressly does not permit
                penalties based on a woman's prior termination of pregnancy.
                 Others, however, supported the incorporation of Title IX's
                religious exemptions and other Federal conscience statutory
                protections, arguing that they are consistent with abortion neutrality.
                Still others stated that discrimination on the basis of sex should not
                include termination of pregnancy at all, under existing law and the
                statutory text of Section 1557 and Title IX. Some submitted legislative
                history from Title IX (Senate Committee Report 100-64) to show that
                Congress intended to allow for abortion exemptions and exclusion of
                health insurance coverage for abortion services, and that Congress did
                not intend to require all hospitals to provide abortion services to the
                general public.\303\ But other commenters were critical of using
                legislative history to interpret a statute.
                ---------------------------------------------------------------------------
                 \303\ See Senate Committee Report 100-64 (``This bill does not
                expand abortion rights. Religiously-controlled organizations will
                continue to be able to apply for, and receive, an exemption from
                Title IX requirements where compliance with those requirements would
                violate their religious tenets. For example, a religiously
                controlled university that wished to exclude insurance coverage of
                abortions from an otherwise comprehensive student health insurance
                policy, could seek a religious exemption. . . . Title IX covers only
                students and employees, and does not reach the public at large.
                Therefore, claims that the bill would require hospitals to provide
                abortion services to the general public are false.'').
                ---------------------------------------------------------------------------
                 Response: This final rule does not remove the language from the
                Department's Title IX regulations that prohibits certain forms of
                discrimination on the basis of ``termination of pregnancy.'' \304\
                However, as stated above in the section on discrimination on the basis
                of sex (subsection on ``termination of pregnancy''), the Title IX
                regulations are governed by the text of the Title IX statute and cannot
                be ``construed to require or prohibit any person, or public or private
                entity, to provide or pay for any benefit or service, including the use
                of facilities, related to an abortion'' (20 U.S.C. 1688). This final
                rule adds language to the Title IX regulations in order to make this
                clear. Although some commenters cite legislative history, the
                Department interprets the statutory text as written. Regardless, the
                Department does not believe there is tension between the legislative
                history and the text.
                ---------------------------------------------------------------------------
                 \304\ See 45 CFR Sec. 86.21(c)(3), 86.40(b)(1), 86.40(b)(4),
                86.40(b)(5), 86.51(b)(2), 86.51(b)(6), 86.57(b), 86.57(c), 86.57(d).
                ---------------------------------------------------------------------------
                 By adding the abortion neutrality language to the Title IX
                regulations, and stating in the Section 1557 regulation that it will be
                applied consistent with Title IX (including that language), this final
                rule ensures compliance with the rationale in Franciscan Alliance,
                where the Court rightly held that the Department's regulations
                forbidding discrimination on the basis of sex must be construed in
                light of the underlying text of Title IX, including abortion
                neutrality.
                 Comment: Commenters stated that religious exemptions would make it
                harder to find healthcare in low provider areas, and that religious
                refusals also harm people who live in rural areas and must travel for
                an abortion. However, other commenters stated that this inclusion of
                various Federal conscience statutes and appropriations riders would
                ensure that healthcare providers who have conscience objections to
                abortion will feel welcome within the healthcare profession and will
                ease retention of healthcare providers already in the field.
                 Some specifically stated their support for the Department's
                inclusion of the First Amendment, and for Department guidance that the
                proposed rule be construed consistent with religious liberty and free
                speech protections, to clarify that the interpretation, application,
                and enforcement of the proposed rule will be consistent with religious
                liberty. Other commenters stated that referring to the First Amendment
                rightly addresses the recent Supreme Court ruling in NIFLA v.
                Becerra.\305\ Commenters were concerned that the 2016 Rule would
                require a faith-based hospital to inform a patient about terminating
                her pregnancy in direct contravention of sincerely-held religious
                beliefs. This would be in conflict with NIFLA, where the Supreme Court
                held that such a mandate ``imposes an unduly burdensome disclosure
                requirement that will chill [] protected speech.'' \306\
                ---------------------------------------------------------------------------
                 \305\ Natl. Inst. of Fam. and Life Advocates v. Becerra, 138 S.
                Ct. 2361 (2018).
                 \306\ Id. at 2378.
                ---------------------------------------------------------------------------
                 Response: The Department agrees that this final rule should be
                construed consistent with the First Amendment, conscience statutes, and
                all relevant statutes and appropriations riders relating to abortion,
                to the extent they remain in effect or applicable. Agency regulations
                are subject to the requirements of the First Amendment in any case, and
                the Department considers it appropriate to say so explicitly here. All
                the other laws referenced establish Congressionally required parameters
                that may apply to the Department's interpretation, implementation, and
                enforcement of Title IX and of this final rule.\307\ Commenters' policy
                objections to these statutory constraints are not a sufficient reason
                for the Department not to finalize this provision of the rule, which
                will ensure compliance with statutory requirements.
                ---------------------------------------------------------------------------
                 \307\ To the extent the relevant provisions are found in an
                appropriations rider, they apply to the Department's interpretation,
                implementation, and enforcement of Title IX every year that they are
                enacted.
                ---------------------------------------------------------------------------
                (3) Summary of Regulatory Changes
                 For the reasons described herein and having considered the comments
                received, the Department finalizes changes to 45 CFR 86.2, 86.18,
                86.31, and 86.71 without change.
                E. Conforming Amendments to CMS Regulations
                 The Department proposed to make conforming amendments to ten
                regulations of CMS that prohibited discrimination on the basis of
                gender identity and/or sexual orientation in the establishment and
                operation of ACA exchanges; in the marketing and design practices of
                health insurance issuers under the ACA; in the administration,
                marketing, and enrollment practices of QHPs under the ACA; in
                beneficiary enrollment and the promotion and delivery of services under
                Medicaid; and in the delivery of services under the PACE program. These
                conforming changes were proposed, among other
                [[Page 37219]]
                reasons, to ensure uniformity across the Department with respect to
                regulations that cover many of the same entities.
                (1) Generally
                 Comment: Several commenters contended that the proposed rule
                exceeds the authority of the Director of OCR by attempting to remove
                references to gender identity and sexual orientation from all HHS
                healthcare regulations, including those issued by other HHS agencies
                unrelated to Section 1557, although the rule purported to be
                promulgated by authority from Section 1557 and other sections within
                the ACA. Commenters stated that the nondiscrimination protections
                proposed to be eliminated from CMS regulations are unrelated to Section
                1557 and its regulation, and that this elimination was proposed without
                sufficient legal, policy, or cost-benefit analyses as well as without
                knowledge of their potential impacts on various CMS programs and on
                LGBT patients, who (commenters said) may be discriminated against if
                these amendments are finalized. Also, commenters contend the conforming
                amendments, if implemented, would affect a wide range of healthcare
                programs, including private insurance and education programs. Some said
                they were unaware of any instances in which inclusion of sexual
                orientation as a basis for nondiscrimination in these CMS rules had
                been challenged or opposed. Others said that it was arbitrary to single
                out sexual orientation and gender identity for elimination, since some
                of the CMS regulations being amended also protect other characteristics
                not expressly enumerated by statute.
                 Response: Both the proposed rule and this final rule are
                promulgated by the Secretary of Health and Human Services, who has
                jurisdiction over all Department regulations, including those falling
                under the jurisdiction of CMS. Moreover, each of the programs,
                activities, or entities in the proposed conforming amendments falls
                within the scope of Section 1557 as entities established under Title I
                of the ACA (for example, Exchanges \308\), entities administered under
                Title I of the ACA (for example, QHPs \309\) or health programs or
                activities receiving Federal financial assistance from the Department,
                including contracts of insurance.\310\ The ACA and certain Federal
                statutes identifying other protected categories provide the bases for
                the nondiscrimination clauses in health programs and activities funded
                or administered by HHS.\311\
                ---------------------------------------------------------------------------
                 \308\ See Public Law 111-148, tit. I, subtit. D, Part II
                (Consumer Choices and Insurance Competition Through Health Benefit
                Exchanges).
                 \309\ See Public Law 111-148, tit. I, subtit. D, Part I
                (Establishment of Qualified Health Plans).
                 \310\ These include Medicare Advantage (Medicare Part C) plans,
                Medicare Part D plans, Medicaid Managed Care Organizations (MCOs),
                Medicaid Prepaid Inpatient Health Plans, (PIHPs), Medicaid Prepaid
                Ambulatory Health Plans (PAHPs), Medicaid Primary Care Case Managers
                (PCCMs), Primary Care Case Management Entities (PCCM-Es) and
                Programs for All-inclusive Care for the Elderly serving Medicare and
                Medicaid beneficiaries (PACE).
                 \311\ See 42 CFR 438.3(d)(4), 438.206(c)(2), 440.262,
                460.98(a)(3), 460.112(a).
                ---------------------------------------------------------------------------
                 The Department has reviewed the legal authorities underlying and
                cited in the nondiscrimination provisions of these CMS regulations and
                the explanations set forth in those rules. Some of them relied on or
                referenced Section 1557, some relied on different statutory provisions,
                and some are cross-referenced in the 2016 Rule. None of the statutory
                authorities underlying the CMS rules amended here explicitly references
                sexual orientation or gender identity. To the extent some of those
                regulations were promulgated based on broad authority to issue
                regulations,\312\ inclusion of nondiscrimination criteria that are not
                explicitly set forth in other applicable civil rights statutes may not
                necessarily exceed the Department's statutory authority. Nevertheless,
                the Department deems it appropriate to pursue a more uniform practice
                concerning nondiscrimination categories across programs and activities
                to which Section 1557 applies, and to do so consistent with the
                government's position concerning discrimination on the basis of sex.
                ---------------------------------------------------------------------------
                 \312\ See, e.g., ACA Section 1321 (42 U.S.C. 18041(a))
                (authorizing the Secretary to ``issue regulations setting standards
                . . . with respect to . . . the establishment and operation of
                Exchanges . . . the offering of qualified health plans through such
                Exchanges . . . and . . . such other requirements as the Secretary
                determines appropriate'').
                ---------------------------------------------------------------------------
                 In addition, for several of the CMS final rules, their
                corresponding proposed rules had not mentioned adding sexual
                orientation and gender identity as nondiscrimination categories.\313\
                Although some of those proposed rules also did not mention adding other
                common nondiscrimination categories, the Department now views the
                addition of sexual orientation and gender identity as nondiscrimination
                categories as having presented different legal and policy concerns from
                other categories. Notably, these nondiscrimination categories are not
                required by applicable law, appear in only a handful of federal
                antidiscrimination statutes, and have been the subject of extensive
                litigation, controversy, and confusion generally. Thus, the Department
                believes the addition of sexual orientation and gender identity as
                nondiscrimination categories in its regulations should have been
                submitted for public comment and, notwithstanding the lack of legal
                challenge to these CMS regulations on this basis, proposes conforming
                amendments for purposes of clarity, consistency, and uniformity.
                ---------------------------------------------------------------------------
                 \313\ See, e.g., 78 FR 13406 (Feb. 27, 2013) (final rule) and 77
                FR 70584, 70585 (Nov. 26, 2012) (NPRM).
                ---------------------------------------------------------------------------
                 Therefore, the Department deems it appropriate to finalize the
                proposed conforming amendments to these CMS regulations without change
                (with the exception of a technical correction described below), in
                order to create a more uniform practice concerning nondiscrimination on
                the basis of sex among HHS programs to which Section 1557 applies, and
                to avoid the possibility that there was insufficient statutory
                authority to impose gender identity or sexual orientation
                nondiscrimination prohibitions through those regulations.
                 The Department is unaware of any data that would make cost-benefit
                analyses for these specific changes possible, and notes that the
                insertion of sexual orientation and gender identity language (repealed
                by these amendments) had already been implemented without any cost-
                benefit analyses. These provisions are eliminated for reasons parallel
                to those put forth here and in the proposed rule with respect to proper
                statutory construction, legal authority, and the Department's policy
                goals.
                 Comment: Some commenters supported proposals to remove the
                provisions prohibiting discrimination on the basis of sexual
                orientation specifically from regulations encompassed by the conforming
                amendments, in order to reflect current law and current regulatory
                policy. They reiterated the 2016 Rule's statement that there is no
                settled statutory law or court-settled law that discrimination on the
                basis of sexual orientation is legally included within the reach of
                Title IX.
                 Response: For the reasons explained above, the Department agrees
                with the 2016 Rule's decision not to include an explicit prohibition on
                sexual orientation discrimination. Similarly, the Department concludes
                it is appropriate to remove such language through these conforming
                amendments.
                (2) Delivery of Medicaid Services (42 CFR 438.3(d)(4), 438.206(c)(2),
                440.262)
                 The Department proposed conforming amendments to multiple
                provisions in Title 42 of the Code of Federal Regulations that apply to
                delivery of
                [[Page 37220]]
                Medicaid services found in Sec. 438.3(d)(4) as applied to MCOs, PIHPs,
                PAHPs, PCCMs or PCCM entities, Sec. 438.206(c)(2) by MCOs, PIHPs, and
                PAHPs participating in State efforts, and Sec. 440.262 by the States
                themselves.
                 Three of the provisions applied to Medicaid managed care. The
                Department proposed on June 1, 2015, and then finalized on May 6, 2016,
                a regulation with several nondiscrimination provisions applicable to
                fee-for-service medical assistance under Medicaid. 80 FR 31098 (June 1,
                2015) (Medicaid NPRM); 81 FR 27895 (May 6, 2016) (Medicaid final rule).
                The Department prohibited discrimination on the basis of ``sexual
                orientation and ``gender identity'' by MCOs, PIHPs, PAHPs, PCCMs, and
                PCCM-Es. 42 CFR 438.3(d)(4). And it required that certain of these
                entities promote access and/or delivery of services ``in a culturally
                competent manner to all enrollees . . . regardless of gender, sexual
                orientation or gender identity.'' 42 CFRSec. 438.206(c)(2).
                 In promulgating these regulations, the Department relied on a
                statute granting general rulemaking authority to the Secretary of HHS
                to make and publish rules and regulations as may be necessary to
                efficiently administer Medicare and Medicaid. Section 1102 of the
                Social Security Act, 42 U.S.C. 1302(a). It also cited provisions of the
                Social Security Act that require Medicaid State plans for medical
                assistance to ``provide . . . such methods of administration . . . as
                are found by the Secretary to be necessary for the proper and efficient
                operation of the plan.'' Section 1902(a)(4) of the Social Security Act
                (42 U.S.C. 1396a(a)). And it cited Section 1902(a)(19) of the Social
                Security Act to justify additional methods of administration and new
                protected categories necessary for the proper operation of a State
                plan, for best interest of the beneficiaries, and for cultural
                competency. 81 FR 27895 (Medicaid final rule). None of these
                authorities prohibits discrimination on the basis of gender identity or
                sexual orientation.
                 In reviewing Sec. 440.262, the Department became aware that in
                proposing a conforming amendment to the first sentence, the proposed
                rule is worded to delete the second sentence of that section, which
                reads ``These methods must ensure that beneficiaries have access to
                covered services that are delivered in a manner that meets their unique
                needs.'' The Department's intent was to make a conforming amendment to
                the first sentence of that section, but not to delete the second
                sentence. Therefore, the Department finalizes the conforming amendment
                to the first sentence of Sec. 440.262 without change, but makes a
                technical correction by finalizing the section to retain the second
                sentence of that section. In other words, the Department is finalizing
                the change to the first sentence of Sec. 440.262, but is not
                finalizing the deletion of the second sentence. In addition, the
                Department corrects the grammar of the second sentence, by changing the
                word ``meet'' to ``meets.'' Medicare's PACE Program Employees and
                Organizations (42 CFR 460.98(b)(3), 460.112(a)).
                 The Department proposed conforming amendments to two provisions
                that apply to PACE, a health program receiving HHS Federal financial
                assistance that is therefore subject to Section 1557.
                 In 2006, the Department promulgated a regulation administering PACE
                that prohibited discrimination on the basis of sexual orientation. 71
                FR 71244 (Dec. 8, 2006) (PACE final rule). Sexual orientation had not
                been identified as a protected category in the statute authorizing
                PACE. See Public Law 98-21, as amended (codified at 42 U.S.C. 1396u-4
                et seq.).
                 In the PACE final rule, in response to a request from two
                commenters to ``broaden the list of categories under which the PACE
                Organization cannot discriminate to include sexual orientation,'' the
                Department agreed to amend 42 CFR 460.98(b)(3) to prohibit
                discrimination on the basis of sexual orientation for Medicare and
                Medicaid participants. The PACE proposed rule also prohibited
                discrimination on the basis of sexual orientation by employees and
                contractors of Medicare-participating PACE programs. 42 CFR 460.112(a)
                (providing that ``[e]ach participant has the right not to be
                discriminated against in the delivery of required PACE services based
                on race, ethnicity, national origin, religion, sex, age, sexual
                orientation, mental or physical disability, or source of payment'').
                 Medicare Part A programs, including PACE, are subject to Title VI,
                Title IX, Section 504, and the Age Act. OCR has the authority to review
                recipient policies and procedures and certify that recipients of
                Federal financial assistance under Medicaid Part A comply with Title
                VI, Title IX, Section 504, and the Age Act, and their implementing
                regulations. CMS now directs applicants to an online attestation portal
                on the OCR website to assure compliance with those four civil rights
                statutes as well as with Section 1557.
                 In reviewing Sec. 460.112(a), the Department became aware that in
                proposing a conforming amendment to the first two sentences, the
                proposed rule is worded to delete the remainder of the subsection. The
                Department's intent was to make a conforming amendment to the first two
                sentences of subsection (a), but not to delete its remainder.
                Therefore, the Department finalizes the conforming amendment to the
                first two sentences of Sec. 460.112(a) without change, but as a matter
                of technical correction does not finalize the deletion of the remaining
                sentences, and instead finalizes subsection (a) to retain the remainder
                of that subsection.
                 Comment: Commenters expressed concern that PACE organizations would
                be allowed to discriminate against LGBTQ people under the proposed
                rule.
                 Response: The Department believes that everyone should be treated
                with dignity and respect and given every protection afforded by the
                Constitution and the laws passed by Congress. None of the statutes
                authorizing the PACE regulations prohibits discrimination on the basis
                of gender identity or sexual orientation.
                (3) General Standards for Exchanges, QHPs for Exchanges, and Health
                Plan Issuers (45 CFR 155.120(c)(ii)), 156.200(e))
                 In 2012, the Department added ``sexual orientation'' and ``gender
                identity'' into certain regulations for the administration of the ACA
                by States, the Exchanges, and QHP issuers. 77 FR 18469 (Mar. 27, 2012)
                (``Administration of Exchanges final rule''). The Department cited
                Section 1321 of the ACA as its authority to add new nondiscrimination
                requirements. 76 FR at 41873, 41897 (July 15, 2011) (``Administration
                of Exchanges proposed rule'').
                 Section 1321 is a general regulatory provision allowing HHS to
                regulate establishment, operation, and standards in Exchanges and for
                QHPs. It does not contain the words ``sexual orientation'' or ``gender
                identity,'' or specify that the authority to set standards includes the
                authority to specify classes protected from discriminatory conduct that
                are not otherwise specified in nondiscrimination statutes.\314\
                Sections 155.120(c)(ii) and 156.200(e) were both later referenced in
                the preamble to the 2016 Rule as nondiscrimination provisions that the
                2016 Rule
                [[Page 37221]]
                ``complements.'' See 81 FR 31376, 31428 (May 18, 2016). The 2016 Rule
                also provided that the States, Exchanges, and issuers are ``obligated
                to comply with both sets of requirements.'' Id.
                ---------------------------------------------------------------------------
                 \314\ Section 1321(a) of the ACA provides that the Secretary of
                the Department of Health and Human Services ``shall, as soon as
                practicable after the date of enactment of this Act, issue
                regulations setting standards for meeting the requirements under
                this title, and the amendments made by this title, with respect to--
                (A) the establishment and operation of Exchanges (including SHOP
                Exchanges); (B) the offering of qualified health plans through such
                Exchanges . . .'' 42 U.S.C. 18041(a)(1)(A)-(B).
                ---------------------------------------------------------------------------
                (4) Guaranteed Coverage (45 CFR 147.104(e))
                 In the February 27, 2013 edition of the Federal Register, the
                Department finalized a new regulation expanding the nondiscrimination
                provisions applicable to QHP issuers, including prohibitions on
                discrimination on the basis of gender identity and sexual orientation,
                citing Section 1321(a) of the ACA as the applicable statutory
                authority. 78 FR 13406 (Guaranteed Coverage final rule, codified at 45
                CFR 147.104(e)). Nevertheless, the language in the final rule
                prohibiting discrimination on the basis of gender identity and sexual
                orientation was not in the proposed rule. See 77 FR 70584, 70613 (Nov.
                26, 2012). It appears that the Department added this language in
                response to a commenter asking that HHS ``broaden[ ] [Sec. 147.104(e)]
                to apply to all forms of discrimination prohibited by the March 27,
                2012 Exchange final rule and section 1557 of the Affordable Care Act,
                such as discrimination based on age, disability, race, ethnicity,
                gender, and sexual orientation, not just discrimination against
                individuals with significant or high cost healthcare needs.'' 78 FR at
                13417.
                 As legal authority, the Department also relied on Section 2702 of
                the Public Health Service Act, as amended by the Affordable Care Act,
                Public Law 111-148 (Mar. 23, 2010), which only required that any
                ``individual or group market in a State must accept every employer and
                individual in the State that applies for such coverage.'' There was no
                explicit reference to categories of individuals protected by
                nondiscrimination laws.
                 The rule administered the ACA's guarantee of coverage in the group
                and individual health insurance markets. See 42 U.S.C. 300gg-1. The
                Department attached the sexual orientation and gender identity
                nondiscrimination provision as part of the requirement for issuers to
                accept every employer and individual in the State who applies for
                coverage, subject to a few exceptions. Section 300gg-1 does not specify
                nondiscrimination criteria, including sexual orientation or gender
                identity.
                 The rule applied not only to the health plan issuer but also to its
                ``officials, employees, agents and representatives.'' 45 CFR
                147.104(e). It prohibited these covered entities from discriminating
                based on a variety of bases, including an individual's sex, sexual
                orientation, or gender identity. Id. In the Guaranteed Coverage final
                rule, the Department justified the 45 CFR 147.104(e) nondiscrimination
                provision on the ground that it ``ensures consistency with . . . the
                non-discrimination standards applicable to QHPs under Sec.
                156.200(e),'' to which sexual orientation and gender identity
                provisions had previously been added (as described above). 78 FR at
                13426. The Guaranteed Coverage final rule was also referenced in the
                preamble to the 2016 Rule, which described it as both ``independent
                of''' and ``complement[ary]'' to Section 1557. 81 FR at 31428.\315\
                ---------------------------------------------------------------------------
                 \315\ See 81 FR 31376, 31428 (May 18, 2016) (``We noted that
                this section [92.207] is independent of, but complements, the
                nondiscrimination provisions that apply to . . . issuers of
                qualified health plans under other Departmental regulations, and
                that entities covered under those provisions and Section 1557 are
                obligated to comply with both sets of requirements.'').
                ---------------------------------------------------------------------------
                 The Department notes that this amendment to the Guaranteed Coverage
                final rule does not negate the rule's requirement that health insurance
                issuers offering group or individual coverage ``must offer to any
                individual or employer in the State all products that are approved for
                sale in the applicable market, and must accept any individual or
                employer that applies for any of those products.'' 45 CFR 147.104(a).
                That requirement applies independent of the explicit nondiscrimination
                categories set forth in Sec. 147.104(a).
                (5) Enrollment in QHPs Through Exchanges by Agents or Brokers (45 CFR
                155.220(j)(2)(i))
                 In the December 2, 2015 edition of the Federal Register, the
                Department proposed a rule that would prohibit agents or brokers from
                discriminating on the basis of sexual orientation and gender identity
                when assisting individuals and employers in applying for or enrolling
                in QHPs sold through a Federally-facilitated Exchange. 80 FR 75488.
                This proposed rule was adopted without change in March of the following
                year. 81 FR 12204 (Mar. 8, 2016) (codified at 45 CFR 155.220(j)(2)(i)).
                The final rule also stated that covered entities must comply with
                ``certain other Federal civil rights laws [that] impose non-
                discrimination requirements,'' such as Section 1557 of the ACA.\316\
                The final rule further directed issuers who seek certification of one
                or more QHPs to the OCR website for information about the Section 1557
                NPRM.\317\
                ---------------------------------------------------------------------------
                 \316\ 81 FR 12312 (``Issuers that receive Federal financial
                assistance, including in connection with offering a QHP on an
                Exchange, are subject to Title VI of the Civil Rights Act of 1964,
                the Age Discrimination Act of 1975, section 504 of the
                Rehabilitation Act of 1973, and section 1557 of the Affordable Care
                Act'').
                 \317\ Id.
                ---------------------------------------------------------------------------
                (6) Enrollment in QHPs and Exchanges by QHP Issuers (45 CFR
                156.1230(b)(2))
                 In the September 6, 2016 edition of the Federal Register, the
                Department proposed a gender identity and sexual orientation
                nondiscrimination provision to rules governing marketing or conduct by
                issuers of individual market QHPs sold through the Federally-
                facilitated Exchanges in the direct enrollment of individuals in a
                manner that is considered to be through the Exchange. 81 FR 61456. The
                rule proposed that QHP issuers would be required to ``refrain from
                marketing or conduct that is misleading . . . coercive, or
                discriminates based on race, color, national origin, disability, age,
                sex, gender identity, or sexual orientation.'' Id. The proposed
                language was finalized that December. 81 FR 94058 (Dec. 22, 2016)
                (codified at 45 CFR 156.1230(b)(3), since redesignated as 45 CFR
                156.1230(b)(2) (see 84 FR 17454, 17568 (Apr. 25, 2019, effective June
                24, 2019))). The Department cited Section 1321 of the ACA as its
                authority to promulgate the nondiscrimination provision. The authority
                section of the regulation also encompasses Section 1311 of the ACA,
                which prohibits QHPs from ``employ[ing] marketing practices or benefit
                designs that have the effect of discouraging the enrollment in such
                plan by individuals with significant health needs.'' \318\
                ---------------------------------------------------------------------------
                 \318\ 42 U.S.C. 18031.
                ---------------------------------------------------------------------------
                (7) Summary of Regulatory Changes
                 The Department finalizes without change the proposed conforming
                amendments at 42 CFR 438.3(d), 438.206(c)(2), and 460.98(b)(3), and 45
                CFRSec. 147.104(e), 155.120(c)(ii), 155.220(j)(2)(i), and 156.200(e).
                It finalizes the proposed conforming amendment of the first sentence of
                Sec. 440.262 without change, but retains the second sentence of that
                section without deleting it, and makes one grammatical correction to
                the second sentence. It finalizes the proposed conforming amendment of
                the first two sentences of Sec. 460.112(a) without change, but retains
                the remainder of that subsection without deleting it.
                 With respect to 45 CFR 156.1230(b)(2), the proposed rule indicated
                it would amend Sec. 156.1230(b)(3), but effective June 24, 2019, Sec.
                156.1230(b)(3) was redesignated as Sec. 156.1230(b)(2). See 84 FR at
                17568.
                [[Page 37222]]
                Therefore, this rule finalizes the change at the redesignated location
                of the text at Sec. 156.1230(b)(2).
                IV. Regulatory Impact Analysis
                 The Department has examined the impacts of this final rule as
                required by Executive Order 12866 on Regulatory Planning and Review, 58
                FR 51735 (Oct. 4, 1993); Executive Order 13563 on Improving Regulation
                and Regulatory Review, 76 FR 3821 (Jan. 21, 2011); Executive Order
                13132 on Federalism, 64 FR 43255 (Aug. 4, 1999); Executive Order 13175
                on Tribal Consultation, 65 FR 67249 (Nov. 6, 2000); Executive Order
                13771 on Reducing Regulation and Controlling Costs, 82 FR 9339 (Jan.
                30, 2017); the Congressional Review Act (Pub. L. 104-121, sec. 251, 110
                Stat. 847 (Mar. 29, 1996)); the Unfunded Mandates Reform Act of 1995,
                Public Law 104-4, 109 Stat. 48 (Mar. 22, 1995); the Regulatory
                Flexibility Act (Pub. L. 96-354, 94 Stat. 1164 (Sept. 19, 1980);
                Executive Order 13272 on Proper Consideration of Small Entities in
                Agency Rulemaking, 67 FR 53461 (Aug. 16, 2002); Executive Order 12250,
                Leadership and Coordination of Nondiscrimination Laws, 45 FR 72995
                (Nov. 2, 1980), and the Paperwork Reduction Act of 1995, 44 U.S.C.
                3501, et seq.
                A. Executive Orders 12866 and Related Executive Orders on Regulatory
                Review
                 Executive Order 12866 directs agencies to assess all costs and
                benefits of available regulatory alternatives and, if regulation is
                necessary, to select regulatory approaches that maximize net benefits
                (including potential economic, environmental, public health and safety
                effects; distributive impacts; and equity). Executive Order 13563 is
                supplemental to Executive Order 12866 and reaffirms the principles,
                structures, and definitions governing regulatory review established
                there.
                 As discussed below, the Department has estimated that this final
                rule will have a beneficial effect on the economy greater than $100
                million in at least one year. Thus, it has been concluded that this
                final rule is economically significant. It has, therefore, been
                determined that this final rule is a ``significant regulatory action''
                under Executive Order 12866 and, accordingly, the Office of Management
                and Budget (OMB) has reviewed this final rule.
                 The executive summary at the beginning of this preamble contains a
                summary of this final rule in its summary of major provisions, and
                describes the reasons it is needed in describing the purpose of this
                final rule.
                (1) Consideration of Regulatory Alternatives
                 The Department carefully considered several alternatives, including
                the option of not pursuing any regulatory changes, but rejected that
                approach for several reasons.
                 First, not pursuing any regulatory changes would be inconsistent
                with the Administration's policies of appropriately reducing regulatory
                burden, in general, with respect to individuals, businesses and others,
                and from the ACA specifically.
                 Second, not pursuing any regulatory change would be inconsistent
                with various court rulings that have rejected or undermined the legal
                positions taken by the Department in the 2016 Rule. It would not, for
                example, ensure that the text of the Code of Federal Regulations
                accurately reflects the vacatur of the provisions including gender
                identity and termination of pregnancy as prohibited grounds of
                discrimination on the basis of sex. It also would not account for the
                decision of the Northern District of Illinois that the ``plain and
                unambiguous'' statutory text of Section 1557 indicated that a plaintiff
                could only use the enforcement mechanism of the underlying civil rights
                statute that corresponds to its claim. Briscoe v. Health Care Serv.
                Corp., 281 F. Supp. 3d 725, 737-38 (N.D. Ill. 2017) (dismissing a
                Section 1557 claim for sex discrimination using a disparate impact
                standard, because plaintiffs cannot bring disparate impact claims under
                Title IX); accord Galuten on Behalf of Estate of Galuten v. Williamson
                Med. Ctr., 2019 WL 1546940, at * (M.D. Tenn. Apr. 9, 2019); E.S. by and
                through R.S. v. Regence BlueShield, 2019 WL 4566053, at *4 (W.D. Wash.
                Sept. 24, 2018); but see Rumble v. Fairview Health Servs., No. 14-cv-
                2037 (SRN/FLN) (D. Minn. Mar. 16, 2017) (declining to determine the
                specific standard on a motion to dismiss and rejecting the implication
                that Congress meant to create a ``new anti-discrimination framework
                completely `unbound by the jurisdiction of the four referenced
                statutes,' '' but concluding Congress ``likely'' intended a single
                standard to avoid ``patently absurd consequences''). In addition, it
                would fail to account for the decisions of Federal courts in
                California, New York, and Iowa that did not recognize disparate impact
                claims for sex discrimination under Section 1557, because such claims
                are not cognizable under Title IX. See Condry v. UnitedHealth Group,
                No. 3:17-cf-00183-VC (N.D. Calif. June 27, 2018) (Slip. Op. at 7);
                Weinreb v. Xerox Business Services, 323 F. Supp. 3d 501, 521 (S.D.N.Y.
                2018); York v. Wellmark, Inc., No. 4:16-cv-00627-RGE-CFB, Slip. Op. at
                *30 (S.D. Iowa Sep. 6, 2017). A court in Pennsylvania similarly
                indicated that there is no disparate impact claim for discrimination on
                the basis of race under Section 1557, because such claims are
                unavailable under Title VI. See Southeastern Pennsylvania v. Gilead,
                102 F. Supp. 3d 688 (E.D. Pa. 2015); but see Callum v. CVS Corp., 137
                F. Supp. 3d 817 (D.S.C. 2015).
                 Third, the Department believes that the status quo would not
                address, much less remedy, public confusion regarding complainants'
                rights and covered entities' legal obligations. The Department believes
                that revisiting the rule will address inconsistences between the
                Department's underlying regulations and the regulations and actions
                taken by other components of the Government. As applied to sex
                discrimination claims, the 2016 Rule set forth a definition of
                discrimination on the basis of sex under Section 1557 implementing
                Title IX that varied from the practice of other Departments. If the
                Department uses interpretations of Title IX that differ from other
                Departments and from the legal interpretation of the U.S. Government as
                set forth by the Department of Justice, it could lead to inconsistent
                outcomes across complainants and covered entities, with the problem
                especially acute in cases involving a single covered entity being
                investigated with respect to the same allegations by multiple
                Departments that come to different conclusions on effectively the same
                question.
                 The Department also considered adding ``gender identity'' and
                ``sexual orientation'' to a definition of ``sex'' or ``on the basis of
                sex'' under Title IX. The Department concluded it is inappropriate to
                do so in light of the ordinary public meaning of discrimination on the
                basis of sex under Title IX. This final rule will also significantly
                restore the ability of States to establish policies in this area, based
                on their weighing of the competing interests at stake. As a policy
                matter, the Department believes State and local entities are better
                equipped to address with sensitivity issues of gender dysphoria, sexual
                orientation, and any competing privacy interests, especially when young
                children or intimate settings are involved. The Department's position
                will not bar covered entities from choosing to grant protections on the
                basis of sexual orientation and gender identity that do not conflict
                with any other Federal law. The Department has also determined that
                economic incentives, performance objectives, or
                [[Page 37223]]
                other related forms of regulation are neither appropriate nor feasible
                solutions to the problems to be solved.
                 The Department also considered simply repealing the 2016 Rule in
                toto and not issuing a replacement regulation. Such an approach would
                be consistent with the Administration's goals of reducing the
                regulatory burden on covered entities, and is allowed under Section
                1557, as that provision does not require the Department to issue
                implementing regulations. However, the Department is committed to
                vigorous enforcement of civil rights and nondiscrimination laws as
                directed by Congress, and considers it worthwhile to set forth that
                commitment in a Section 1557 regulation which takes the position that
                the Department will use the enforcement mechanisms available under the
                statutes cited in Section 1557 and their underlying regulations.
                Additionally, the Department believes that certain provisions--such as
                those addressing the assurance of compliance with Section 1557,
                effective communication and accessibility for individuals with
                disabilities, and certain language access services--address
                applications of civil rights laws without the statutory or legal
                conflicts, or excessive regulatory burdens, entailed by other
                provisions of the current Rule.
                 The Department also considered retaining the provision on visual
                standards for video remote interpreting services for LEP individuals.
                However, the burden of requiring covered entities to provide video
                technology training and utilize expensive software does not appear to
                be justified based on minimal benefit to language speakers who can
                effectively communicate when there is clear audio transmission through
                the remote interpreting service.
                 Accordingly, the Department believes it is appropriate to clarify
                how OCR will enforce the ACA's nondiscrimination protections by
                replacing the 2016 Rule with regulatory provisions (1) applying the
                enforcement mechanisms provided under the civil rights statutes and
                related implementing regulations cited in Section 1557 to the contexts
                identified in Section 1557, (2) vesting enforcement authority under
                Section 1557 with the Director of the Office for Civil Rights, and (3)
                specifying how Section 1557 enforcement shall interact with existing
                laws--while retaining certain language and disability access provisions
                and the assurances provision.
                 With respect to the requirement that covered entities provide
                nondiscrimination notices and taglines, the Department considered
                keeping the requirement but limiting the frequency of required mailings
                to one per year to each person served by the covered entity. To
                estimate the cost of this option, the Department adopted the base
                assumptions described in this Regulatory Impact Analysis regarding the
                number of covered entities and the average unit cost associated with
                the low-end and high-end costs of a notice and taglines mailing
                (materials, postage, and labor).\319\ The Department adjusted the
                volume of mailings based on the average number of individuals served by
                each covered entity.\320\ The Department assumed the same covered
                entity compliance rate for the insurance industry as under this
                Regulatory Impact Analysis but assumed an increased compliance rate for
                non-insurers (assuming 30% instead of 10%) to reflect that more
                entities would likely comply with the requirements if the burden were
                to be significantly reduced to one mailing per customer/patient per
                year. Based on this method, the estimated total cost of this
                alternative is approximately $63 million per year. Although this option
                poses a significantly reduced burden, the Department believes the costs
                under this alternative still outweigh the benefits because such mass
                multi-language taglines mailings would still be received overwhelmingly
                by English speakers and because the requirement to issue
                nondiscrimination notices would be largely duplicative of
                nondiscrimination notice requirements that already exist under Section
                1557's underlying civil rights regulations.\321\
                ---------------------------------------------------------------------------
                 \319\ The average of the low ($0.035) and high ($0.32) unit
                costs is $0.18 per notice and tagline mailing.
                 \320\ The estimated volume is expected to vary based on covered
                entity type. For instance, each of the 180 health insurance issuers
                serve 685,138 individuals on average, based on the number of insured
                individuals (123 million), which equates to 685,138 mailings per
                issuer. Each of the 185,649 physicians' offices serve 1,703
                individuals, based on the average number of individuals (316
                million) associated with 990 million physicians visits. On average,
                each covered entity serves about 3,000 persons per entity, which
                equates to 3,000 mailings per entity, based on 820 million persons
                served by 275,002 covered entities.
                 \321\ See 45 CFR 80.6(d) (Title VI), 84.8 (Section 504), 86.9
                (Title IX), 91.32 (Age Act).
                ---------------------------------------------------------------------------
                (2) Considerations for Cost-Effective Design
                 In this final rule, the Department replaces much of the 2016 Rule,
                to significantly reduce regulatory burdens and to return to the
                longstanding understanding of the underlying nondiscrimination
                obligations imposed by the civil rights laws referenced in Section
                1557.
                 In the preamble to the 2016 Rule, the Department observed that
                there were pre-existing requirements under Federal civil rights laws
                that, ``except in the area of sex discrimination,'' applied to a large
                percentage of entities covered by the 2016 Rule. 81 FR at 31446. Thus,
                in the 2016 Rule the Department concluded it did not expect covered
                entities to undertake additional costs with respect to that rule's
                prohibitions on discrimination on the basis of race, color, national
                origin, age, or disability, ``except with respect to the voluntary
                development of a language access plan.'' Id.
                 By finalizing this rule without the 2016 Rule's definition of sex
                discrimination and eliminating the requirements regarding notices,
                taglines, and visual standards in video remote interpreting services
                for LEP individuals, language access plans, and duplicative grievance
                procedures, the final rule also allows covered entities the freedom to
                order their operations more efficiently, more flexibly, and in a more
                cost-effective manner.
                 Accordingly, returning to the familiar longstanding requirements is
                a cost-effective way of (1) removing the unjustified burdens imposed by
                the 2016 Rule; (2) reducing confusion among the public and covered
                entities; (3) promoting consistent, predictable, and cost-effective
                enforcement; and (4) creating space for innovation in the provision of
                compliant services by covered entities (including flexible and
                innovative language access practices and technology), while faithfully
                and vigorously enforcing Section 1557's civil rights protections.
                (3) Methodology for Cost-Benefit Analysis
                 For purposes of this Regulatory Impact Analysis (RIA), the final
                rule adopts the list of covered entities and other cost assumptions
                identified in the 2016 Rule's RIA and that of the 2019 proposed rule.
                The use of assumptions from the 2016 Rule in the present RIA, however,
                does not mean that the Department adopts those assumptions in any
                respect beyond the purpose of estimating (1) the number of covered
                entities that would be relieved of burden, and (2) cost relief. For
                example, the 2016 Rule based several cost estimates on an expansive
                definition of Federal financial assistance, which significantly
                impacted the number of covered entities currently burdened by the 2016
                Rule; thus, it is appropriate to use that definition for estimating
                cost relief. Such use, however, should not be interpreted as an
                endorsement or
                [[Page 37224]]
                acceptance of the definition for any other purpose.
                 The Department also does not ``carry over'' every assumption from
                the 2016 Rule for this final rule's RIA calculation. Most notably, the
                Department no longer considers its prior estimates of costs imposed due
                to the 2016 Rule's taglines requirement to be accurate or valid, and
                provides a more thorough and accurate estimate for purposes of this
                final rule.
                 Cost savings result from the repeal of (1) the provision on the
                incentive for covered entities to develop language access plans and (2)
                the provisions on notice and taglines. In addition, the Department
                quantitatively analyzes and monetizes the impact that this final rule
                may have on covered entities' voluntary actions to re-train their
                employees on, and adopt policies and procedures to implement, the legal
                requirements of this final rule. The Department analyzes the remaining
                benefits and burdens qualitatively because of the uncertainty inherent
                in predicting other concrete actions that such a diverse scope of
                covered entities might take in response to this final rule.
                 The Department also considered the public comments submitted in
                response to the proposed rule. The Department appreciates the
                information and various perspectives provided in those comments, which
                are summarized below and for which responses are provided.\322\
                ---------------------------------------------------------------------------
                 \322\ The population, labor, and similar statistical data used
                in this RIA are also not changed from those used in the RIA in the
                proposed rule, because updating that data from the time of the
                proposed rule in June 2019 to the time of the publication of this
                final rule would not lead to substantive changes in the analysis.
                ---------------------------------------------------------------------------
                (4) Cost-Benefit Analysis
                a. Overview
                 In the 2016 Rule, the Department estimated $942 million \323\ in
                costs (over five years) due to impacts on personnel training and
                familiarization, enforcement, posting of nondiscrimination notices and
                taglines, and revisions in covered entity policies and procedures. 81
                FR 31446, and 31458-59 (at Table 5). As stated earlier, the Department
                estimated in the 2016 Rule that these costs would arise primarily from
                requirements imposed by the 2016 Rule with which covered entities were
                not already complying.\324\ The Department specifically identified the
                2016 Rule's interpretation of sex discrimination to cover gender
                identity and sex stereotyping,\325\ and the 2016 Rule's consideration
                of language access plans for compliance purposes, as provisions
                triggering the imposition of new costs.\326\ See 81 FR 31459--Table 5.
                ---------------------------------------------------------------------------
                 \323\ Throughout the regulatory impact analysis in the 2016
                Rule, the 2016 estimates used 2014 dollars unless otherwise noted.
                 \324\ 81 FR 31446 (``to the extent that certain actions are
                required under the final rule where the same actions are already
                required by prior existing civil rights regulations, we assume that
                the actions are already taking place and thus that they are not a
                burden imposed by the rule'').
                 \325\ 81 FR 31455 (``Although a large number of providers may
                already be subject to state laws or institutional policies that
                prohibit discrimination on the basis of sex in the provision of
                health services, the clarification of the prohibition of sex
                discrimination in this regulation, particularly as it relates to
                discrimination on the basis of sex stereotyping and gender identity,
                may be new.'').
                 \326\ Although the 2016 Rule did not require covered entities to
                develop a language access plan, the Rule stated that the development
                and implementation of a language access plan is a factor the
                Director ``shall'' take into account when evaluating whether an
                entity is in compliance with Section 1557. 45 CFR 92.201(b)(2).
                Therefore, the Department anticipated that 50% of covered entities
                would be induced to develop and implement a language access plan
                following issuance of the 2016 Rule. 81 FR 31454.
                ---------------------------------------------------------------------------
                 In 2016, the Department estimated that the 2016 Rule's
                nondiscrimination notice requirement would impose approximately $3.6
                million in one-time additional costs on covered entities. 81 FR 31469.
                Regarding these requirements, the Department stated: ``We are uncertain
                of the exact volume of taglines that will be printed or posted, but we
                estimate that covered entities will print and post the same number of
                taglines as notices and therefore the costs would be comparable to the
                costs for printing and disseminating the notice, or $3.6 million.'' 81
                FR 31469. Thus, the total notice and taglines cost was estimated at
                $7.2 million in the first year and was predicted to go down to zero
                after year one, despite the regulatory requirement for covered entities
                to provide notices and taglines to beneficiaries, enrollees, and
                applicants by appending notices and taglines to all ``significant
                publications and significant communications'' larger than postcards or
                small brochures. Compare 81 FR 31458 (Table 5), with 45 CFR 92.8.
                 For reasons explained more fully below, the 2016 estimate of $7.2
                million in one-time costs stemming from the notice and taglines
                requirement was a gross underestimation, and thus this final rule's
                elimination of those requirements would generate a large economic
                benefit of approximately $2.9 billion over five years on the repeal of
                the notice and taglines provision.
                 Table 1 shows the expected cost savings from the repeal of the
                notice and taglines provision and the quantified costs to firms for
                training and revising procedures and policies.
                 Table 1--Accounting Table of Economic Benefits and Costs of All Finalized Changes
                 [In millions]
                ----------------------------------------------------------------------------------------------------------------
                 Year 1 Year 2 Year 3 Year 4 Year 5 Total
                ----------------------------------------------------------------------------------------------------------------
                Savings:
                 Total (undiscounted).......... $643 $614 $585 $556 $528 $2,926
                 Total (3%).................... 624 579 536 494 455 2,688
                 Total (7%).................... 601 536 478 425 376 2,416
                Costs--Quantified Costs:
                 Total (undiscounted).......... 276 0 0 0 0 276
                 Total (3%).................... 269 0 0 0 0 269
                 Total (7%).................... 259 0 0 0 0 259
                 -----------------------------------------------------------------------------
                 Net Total ........... ........... ........... ........... ........... 2,650
                 (undiscounted [bond] $2,319 (3%)
                 3% [bond] 7%)........ $2,157 (7%)
                ----------------------------------------------------------------------------------------------------------------
                Non-quantified benefits and costs are described below.
                [[Page 37225]]
                b. Generally Applicable Benefits and Burdens
                i. Simplification and Flexibility
                 This final rule would result in other tangible benefits for covered
                entities. First, because this final rule is simpler and more easily
                administrable, it would be less likely that covered entities will need
                to pay for legal advice or otherwise expend organizational resources to
                understand their obligations under Section 1557, either in general or
                with respect to any particular situation that arises. Second, this
                final rule reduces the need for covered entities to expend labor and
                money on an ongoing basis to maintain internal procedures for
                mitigating the legal risk that persists due to unresolved controversy
                over the meaning of Section 1557. The Department solicited comment
                regarding the nature and magnitude of such ongoing costs incurred by
                covered entities, and below the Department summarizes and responds to
                significant comments regarding the regulatory impact of changes to the
                notice and taglines requirements.
                 This final rule will also carry intangible benefits, including that
                covered entities would enjoy increased freedom to adapt their Section
                1557 compliance programs to most efficiently address their particular
                needs, benefiting both covered entities and individuals. The value of
                knowledge of civil rights is difficult to quantify. Covered entities
                will be free under the final rule to implement policies and procedures
                that comply with Federal civil rights laws in creative, effective, and
                efficient ways that are tailored to the covered entities and the
                communities that they serve.
                ii. Policies and Procedures Concerning Gender Identity
                 In the proposed rule, the Department anticipated that the 2016 Rule
                likely induced many covered entities to conform their policies and
                operations to reflect gender identity as a protected category under
                Title IX. The Department requested and received public comments on the
                possible benefits and burdens related to changes in the proposed rule.
                 Comment: Many commenters contended that the proposed rule would
                lead covered entities to remove protections from transgender
                individuals in their policies and procedures. Commenters contended that
                these changes would lead to a wide range of burdensome results,
                including discrimination on the basis of gender identity and resulting
                negative health consequences, increased costs for treatment of such
                conditions, cost-shifting to transgender individuals, and increased
                burdens on the public health system due to the changes. Commenters also
                contended that similar results would occur from the Department's
                decision not to include sexual orientation nondiscrimination provisions
                in the proposed rule.
                 Response: The Department does not believe that this final rule will
                lead to significant burdens on entities due to changes to the gender
                identity language from the 2016 Rule, nor that the commenters have
                identified sufficient data to show that these negative consequences
                will occur or the extent to which they will occur. In December 2016,
                the Franciscan Alliance court preliminarily enjoined the gender
                identity provisions of the 2016 Rule on a nationwide basis, and more
                recently the court vacated those provisions. Consequently, this final
                rule's revisions to the provisions addressing gender identity do not
                change covered entities' obligations. Therefore, even though some
                entities may have changed their policies and procedures at the outset
                of the 2016 Rule, the Department concludes that because the gender
                identity provisions of the 2016 Rule have been vacated prior to this
                rule being finalized, it is even less likely than at the time of the
                proposed rule that this final rule will lead to changes in policies and
                procedures concerning gender identity. In addition, as explained above,
                the 2016 Rule did not include language prohibiting discrimination on
                the basis of sexual orientation status standing alone as a form of sex
                discrimination. The Department therefore does not anticipate any
                material change to covered entities' policies concerning sexual
                orientation as a result of this final rule.
                 In addition, it is worth noting that many covered entities are
                located in jurisdictions that prohibit sexual orientation and gender
                identity discrimination under State or local laws. Therefore, such
                entities are unlikely to change their policies, training, or grievance
                procedures concerning gender identity as a result of this final rule.
                Moreover, nothing in this final rule, or in the court decisions,
                prohibits entities from maintaining gender identity nondiscrimination
                policies and procedures voluntarily, and the Department believes some
                covered entities will continue to do so.
                 If some entities change their policies and procedures based on this
                final rule, such a reversion may entail amending organizational
                nondiscrimination policies and training materials, and communicating
                those changes to employees. The process of voluntarily reverting to
                previous practices would likely result in net cost savings to covered
                entities. Otherwise these entities likely would not take such action.
                In addition, the Department believes that, if this final rule led to
                covered entities changing policies and procedures, some covered
                entities may no longer incur costs associated with processing
                grievances related to gender identity discrimination under Title IX,
                because such claims will not be cognizable under this final rule.
                 The Department, however, is uncertain as to the total number of
                covered entities that will change their policies and grievance
                processes to reflect the changes in this final rule. The reasons for
                this uncertainty include, as stated above, the fact that such changes
                would only be indirectly attributable to this rule, not caused by this
                rule, because previous court rulings have negated the gender identity
                provisions from the 2016 Rule for over three years, and this rule has
                no effect on State and local gender identity protections. The
                Department is not aware of data about how many entities might change
                their policies for these indirect reasons.
                 Similarly, the Department also lacks the data necessary to estimate
                the number of individuals who currently benefit from covered entities'
                policies governing discrimination on the basis of gender identity who
                would no longer receive those benefits after publication of this rule--
                nor data to estimate how many of those individuals may experience the
                workplace and health-related negative consequences that many commenters
                contend will result from this final rule. The Department similarly
                lacks data to estimate what greater public health costs, cost-shifting,
                and expenses may result from entities changing their nondiscrimination
                policies and procedures after promulgation of this rule. The Department
                reiterates that it believes these effects will be minimal, again due to
                the fact that gender identity provisions were vacated from the 2016
                Rule by the Franciscan Alliance court before this rulemaking was
                finalized.
                c. Baseline Assumptions
                 The following discussion identifies the economic baselines from
                which the Department measures the expected costs and benefits of this
                final rule. Its baselines includes the cost estimates in the 2016 Rule,
                in addition to data it has gathered since the 2016 Rule was
                implemented, as described in more detail below. The Department also
                considered public comments, and
                [[Page 37226]]
                responds to significant comments in this discussion.
                 Key assumptions track those set forth in the proposed rule and
                include the following: (1) The 2016 Rule triggered significant activity
                on the part of covered entities, generating both costs and benefits;
                (2) under the December 2016 nationwide preliminary injunction in
                Franciscan Alliance, and the October 2019 final judgment in that case,
                the gender identity and termination of pregnancy provisions of the 2016
                Rule have been unenforceable and are now absent from the 2016 Rule,
                without regard to whether this rule is finalized; (3) covered entities
                were already generally complying with civil rights laws and related
                regulations that were in effect before the 2016 Rule, and so this final
                rule generally does not impose any new burden beyond those imposed
                prior to the issuance of the 2016 Rule; \327\ (4) the projected costs
                from the 2016 Rule for years 1 and 2 have been incurred, and the
                projected costs from years 3, 4, and 5 have not been incurred; (5)
                repeal of the 2016 Rule's notice and taglines requirements does not
                affect notice or taglines requirements required by CMS guidance or
                regulations that do not reference, rely on, or depend upon the taglines
                requirements of the 2016 Rule; (6) a relatively small percentage of
                physicians and hospitals currently append notices and taglines to
                billing statements sent to patients, while all insurance companies
                append notices and taglines to their explanations of benefits
                statements; and (7) covered employers are more likely to train
                employees who interact with the public than those who do not.
                ---------------------------------------------------------------------------
                 \327\ OMB Circular A-4 discusses the practice whereby an RIA for
                a rule codifying a policy may include the impacts of that policy,
                even if the effects follow directly from an action by another branch
                of the federal government. The Circular notes that: ``In some cases,
                substantial portions of a rule may simply restate statutory
                requirements that would be self-implementing, even in the absence of
                the regulatory action. In these cases, you should use a pre-statute
                baseline. If you are able to separate out those areas where the
                agency has discretion, you may also use a post-statute baseline to
                evaluate the discretionary elements of the action.'' Although a
                baseline established prior to the Franciscan Alliance court's
                December 2016 and October 2019 orders would be considered analogous
                to the pre-statute baseline discussed in Circular A-4, given the
                existence of the RIA for the 2016 Rule, an assessment relative to a
                pre-Franciscan Alliance baseline would add little to the body of
                relevant analysis, and the longstanding duration of the court orders
                contributes to a lack of new data pertaining to certain alleged
                effects of language falling under those orders. For these reasons,
                the baseline established after December 2016, which isolates the
                effects most directly attributable to certain elements of this
                rule's finalization, is emphasized throughout the relevant parts of
                this RIA.
                ---------------------------------------------------------------------------
                d. Covered Entities
                i. Entities Covered by Section 1557
                 The 2016 Rule and this final rule apply to any entity that has a
                health program or activity, any part of which receives Federal
                financial assistance from the Department, any program or activity
                administered by the Department under Title I of the ACA, or any program
                or activity administered by an entity established under such Title.
                Covered entities under the 2016 Rule's definition \328\ include the
                following:
                ---------------------------------------------------------------------------
                 \328\ As noted above, we use the list and number of covered
                entities and other figures from the 2016 Rule's RIA in this RIA for
                the sake of consistency and convenience, but such use does not mean
                that we adopt or accept any of the underlying analysis, definitions,
                or assumptions from the 2016 Rule's RIA for any other purpose
                related to this final rule.
                ---------------------------------------------------------------------------
                (A) Entities With a Health Program or Activity, Any Part of Which
                Receives Federal Financial Assistance From the Department
                 The RIA for the 2016 Rule stated that the Department, through
                agencies such as the Health Resources and Services Administration
                (HRSA), the Substance Abuse and Mental Health Services Administration
                (SAMHSA), the Centers for Disease Control and Prevention (CDC), and the
                Centers for Medicare & Medicaid Services (CMS), provides Federal
                financial assistance through various mechanisms to health programs or
                activities of local governments, State governments, and the private
                sector. An entity may receive Federal financial assistance from more
                than one component in the Department. For instance, Federally qualified
                health centers receive Federal financial assistance from CMS by
                participating in Medicaid programs and may also receive Federal
                financial assistance from HRSA through grant awards. Because more than
                one funding stream may provide Federal financial assistance to an
                entity, the examples we provide may not uniquely capture entities that
                receive Federal financial assistance from only one component of the
                Department. Under the 2016 Rule, the covered entities consisted of the
                following:
                 (i) Entities receiving Federal financial assistance through their
                participation in Medicare (excluding Medicare Part B) or Medicaid
                (about 133,343 facilities).\329\ Examples of these entities cited in
                the 2016 Rule's RIA include:
                 \329\ CMS, Provider of Service file (June 2014), https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Provider-of-Services/POS2014.html.
                ---------------------------------------------------------------------------
                 Hospitals (includes short-term, rehabilitation, psychiatric,
                and long-term)
                 Skilled nursing facilities/nursing facilities (facility-based
                and freestanding)
                 Home health agencies
                 Physical therapy/speech pathology programs
                 End-stage renal disease dialysis centers
                 Intermediate care facilities for individuals with intellectual
                disabilities
                 Rural health clinics
                 Physical therapy--independent practice
                 Comprehensive outpatient rehabilitation facilities
                 Ambulatory surgical centers
                 Hospices
                 Organ procurement organizations
                 Community mental health centers
                 Federally qualified health centers.
                 (ii) Laboratories that are hospital-based, office-based, or
                freestanding that receive Federal financial assistance through Medicaid
                payments for covered laboratory tests (about 445,657 laboratories with
                Clinical Laboratory Improvement Act certification).
                 (iii) Community health centers receiving Federal financial
                assistance through grant awards from HRSA (1,300 community health
                centers).\330\
                ---------------------------------------------------------------------------
                 \330\ HRSA, Justification of Estimates for Appropriation
                Committee For Fiscal Year 2016, 53, http://www.hrsa.gov/about/budget/budgetjustification2016.pdf.
                ---------------------------------------------------------------------------
                 (iv) Health-related schools in the United States and other health
                education entities receiving Federal financial assistance through grant
                awards to support 40 health professional training programs that include
                oral health, behavioral health, medicine, geriatric, and physician's
                assistant programs.\331\
                ---------------------------------------------------------------------------
                 \331\ HRSA, Justification of Estimates for Appropriation
                Committee For Fiscal Year 2016, 53, http://www.hrsa.gov/about/budget/budgetjustification2016.pdf.
                ---------------------------------------------------------------------------
                 (v) State Medicaid agencies receiving Federal financial assistance
                from CMS to operate CHIP (includes every State, the District of
                Columbia, Puerto Rico, Guam, the Northern Marianas, U.S. Virgin
                Islands, and American Samoa).
                 (vi) State public health agencies receiving Federal financial
                assistance from CDC, SAMHSA, and other HHS components (includes each
                State, the District of Columbia, Puerto Rico, Guam, the Northern
                Marianas, U.S. Virgin Islands, and American Samoa).
                 (vii) QHP issuers receiving Federal financial assistance through
                advance payments of premium tax credits and cost-sharing reductions
                (which include at least the 169 health insurance issuers in the
                Federally-facilitated Exchanges receiving Federal financial assistance
                [[Page 37227]]
                through advance payments of premium tax credits and cost-sharing
                reductions, and at least 11 health insurance issuers operating in the
                State Exchanges).\332\
                ---------------------------------------------------------------------------
                 \332\ Qualified Health Plans Landscape Individual Market Medical
                (2015), https://data.healthcare.gov/dataset/2015-QHP-Landscape-Individual-Market-Medical/mp8z-jtg7.
                ---------------------------------------------------------------------------
                 (viii) Physicians receiving Federal financial assistance through
                Medicaid payments, ``meaningful use'' payments, and other sources, but
                not Medicare Part B payments (Medicare Part B payments to physicians
                are not Federal financial assistance). The Medicare Access and CHIP
                Reauthorization Act amended Section 1848 of the Act to sunset
                ``meaningful use'' payment adjustments for Medicare physicians after
                the 2018 payment adjustment.
                 In the 2016 Rule, the Department estimated that that rule likely
                covered almost all licensed physicians because they accept Federal
                financial assistance from sources other than Medicare Part B. Many
                physicians participate in more than one Federal, State, or local health
                program that receives Federal financial assistance, and many practice
                in several different settings, which increases the possibility that
                they may receive payments constituting Federal financial assistance.
                 For the sake of consistency and convenience, the Department uses
                the 2016 Rule's RIA estimate of the number of physicians receiving
                Federal financial assistance. As the 2016 Rule RIA noted, based on 2010
                Medicaid Statistical Information System data (the latest available),
                about 614,000 physicians accept Medicaid payments and are covered under
                Section 1557 as a result.\333\ This figure represents about 69% of
                licensed physicians in the United States, based on the 890,000 licensed
                physicians reported in the Area Health Resource File.\334\ In addition,
                physicians receiving Federal payments from non-Part B Medicare sources
                will also come under Section 1557. The 2016 RIA noted that, as of
                January 2014, 296,500 Medicare-eligible professionals had applied for
                funds to support their ``meaningful use'' technology efforts.\335\
                Adding the approximately 614,000 physicians who receive Medicaid
                payments to the 296,500 physicians who receive meaningful use payments
                would yield over 900,000 physicians potentially reached by Section 1557
                because they participate in Federal programs other than Part B of
                Medicare. Because physicians can receive both Medicaid and meaningful
                use payments, and these figures are not adjusted for duplication, the
                900,000 result is best interpreted as an upper bound.
                ---------------------------------------------------------------------------
                 \333\ John Holahan and Irene Headen, Kaiser Commission on
                Medicaid and the Uninsured, Medicaid Coverage and Spending in Health
                Reform: National and State-by-State Results for Adults at or Below
                133% FPL (2010), https://kaiserfamilyfoundation.files.wordpress.com/2013/01/medicaid-coverage-and-spending-in-health-reform-national-and-state-by-state-results-for-adults-at-or-below-133-fpl.pdf.
                Estimates are based on data from FY 2010 MSIS.
                 \334\ HRSA, Area Health Resource Files (2015), http://ahrf.hrsa.gov.
                 \335\ Mynti Hossain and Marsha Gold, Mathematical Policy
                Research Inc.: Prepared for The Office of the National Coordinator
                for Health Information Technology, HHS, Monitoring National
                Implementation of HITECH: Status and Key Activity Quarterly Summary
                (Jan. to Mar. 2014), http://www.healthit.gov/sites/default/files/globalevaluationquarterlyreport_januarymarch2014.pdf.
                ---------------------------------------------------------------------------
                 When the Department compared the upper-bound estimated number of
                physicians participating in Federal programs other than Medicare Part B
                (over 900,000) to the number of licensed physicians counted in HRSA's
                Area Health Resource File (approximately 890,000), and allowing for
                duplication in both the Medicare/Medicaid and HRSA numbers,\336\ the
                Department concluded in the 2016 Rule RIA that almost all practicing
                physicians in the United States are reached by Section 1557 because
                they accept some form of Federal remuneration or reimbursement apart
                from Medicare Part B.
                ---------------------------------------------------------------------------
                 \336\ The Area Health Resource File itself double counts
                physicians who are licensed in more than one State.
                ---------------------------------------------------------------------------
                (B) Programs or Activities Administered by the Department Under Title I
                of the ACA
                 This final rule applies to programs or activities administered by
                the Department under Title I of the ACA. Such programs or activities
                include temporary high-risk pools (section 1101), temporary reinsurance
                for early retirees (section 1102), Department mechanisms for
                identifying affordable health insurance coverage options (section
                1103), the wellness program demonstration project (section 1201, adding
                Public Health Service (PHS) Act 2705(l)), the provision of community
                health insurance options (section 1323), and the establishment of risk
                corridors for certain plans (section 1342).
                (C) Entities Established Under Title I of ACA
                 This final rule applies to the health insurance exchanges
                established under Title I of the ACA. Such exchanges currently include
                the 12 State Exchanges (and D.C. Exchange), six State Exchanges on the
                Federal platform and 32 Federally-facilitated Exchanges.\337\ Title I
                additionally establishes State advisory councils concerning community
                health insurance (section 1323) and certain reinsurance entities under
                the transitional reinsurance program (section 1341).
                ---------------------------------------------------------------------------
                 \337\ CMS, State-Based Exchanges for Plan Year 2018 (Nov. 1,
                2019), https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/state-marketplaces.html.
                ---------------------------------------------------------------------------
                ii. Entities Covered by Title IX
                 Title IX applies to recipients of Federal financial assistance for
                education programs or activities. 20 U.S.C. 1681. The population of
                applicable covered entities is defined by the term ``recipient'' in the
                Department's Title IX regulations. The population includes any State or
                political subdivision thereof, or any instrumentality of a State or
                political subdivision thereof, any public or private agency,
                institution, or organization, or other entity, or any person, to whom
                Federal financial assistance is extended directly or through another
                recipient and that operates an education program or activity that
                receives such assistance, including any subunit, successor, assignee,
                or transferee thereof. See, e.g., 45 CFR 86.2. Under the definition of
                program or activity, recipients of Federal financial assistance within
                the scope of Title IX may include colleges, universities, local
                educational agencies, vocational education systems, or other entities
                or organizations principally engaged in the business of providing
                education. See, e.g., 45 CFR part 86, App. A (cross-referencing
                Appendix B to 45 CFR part 80).
                e. Cost Savings From Eliminating Notice and Taglines Requirement
                 The Department's baseline for calculating the savings from
                repealing the notice and taglines requirement includes approximately
                $585 million in additional average annual costs (over the next five
                years) that were not considered in the 2016 Rule. It is important to
                note that, while industry estimates prompted the Department to reassess
                the burdens imposed by the 2016 Rule, the Department conducted and
                relied upon its own cost analysis in developing the RIA for this final
                rule.
                 The 2016 Rule estimated $7.1 million for covered entities and
                $70,400 for the Federal government in combined annual costs for
                printing and distributing nondiscrimination notices and taglines, with
                the costs being apportioned roughly equally between notices and
                taglines. 81 FR at 31453. As explained in detail below, the Department
                estimates the combined notice and taglines requirement has actually
                cost
                [[Page 37228]]
                covered entities hundreds of millions of dollars per year.
                 The 2016 Rule requires covered entities to include a notice and
                taglines for any ``significant'' document or publication, but did not
                define the term ``significant.'' 45 CFR 92.8(f)(1)(i).\338\ Thus,
                covered entities have interpreted this provision to require a notice
                and taglines to accompany many communications from covered entities,
                including annual benefits notices, medical bills from hospitals and
                doctors, explanations of benefits from health insurance companies or
                health plans, and communications from pharmacy benefit managers.
                ---------------------------------------------------------------------------
                 \338\ After publishing the 2016 Rule, OCR issued guidance
                explaining that any significant publication printed on an 8.5 x 11
                sheet of paper is not considered small sized and, thus, must include
                a minimum of 15 taglines. See OCR, Question 23, General Questions
                about Section 1557 (May 18, 2017), https://www.hhs.gov/civil-rights/for-individuals/section-1557/1557faqs/index.html.
                ---------------------------------------------------------------------------
                 This led to an extraordinary amount of mailed or electronically
                delivered communications by entities such as plan administrators and
                pharmacy benefit managers, including with every auto-ship refill
                reminder, formulary notice, and specialty benefit letter. Further, some
                other entities that operate in multiple States have interpreted the
                2016 Rule as requiring them to include taglines for as many as 60
                languages, or have included that many taglines in mailed or
                electronically-delivered communications due to the cost or technical
                barriers to customizing mailing inserts on a State-by-State basis, and
                thus have incurred costs to send up to an additional two double-sided
                pages of notices with each communication.\339\
                ---------------------------------------------------------------------------
                 \339\ Although OCR has issued guidance stating that a covered
                entity may identify the top 15 languages spoken across all the
                States that the entity serves, See https://www.hhs.gov/civil-rights/for-individuals/section-1557/1557faqs/aggregation_tagline/index.html, evidence of notices that some covered entities shared
                with OCR suggests covered entities with beneficiaries in multiple
                States may issue more comprehensive tagline notices with more than
                15 languages, likely because of reasonable interpretations of the
                relevant provisions of the 2016 Rule, and the higher cost of
                attempting to tailor notices and taglines to individuals based on
                their specific State.
                ---------------------------------------------------------------------------
                 To estimate the volume of notices and taglines that accompany an
                annual benefits notice, we began with the approximately 300 million
                persons in the United States who have health insurance,\340\ or
                approximately 91% of the U.S. population. The Department then assumed
                that the annual notice of benefits (that includes a notice and
                taglines) is sent to each policyholder, not to each individual member
                of a covered household, such as covered children. Of the total U.S.
                population, 306 million individuals belong to 117.7 million households.
                For the data set relied on, a ``household'' includes ``all the people
                who occupy a housing unit . . . . The occupants may be a single family,
                one person living alone, two or more families living together, or any
                other group of related or unrelated people \341\ who share living
                arrangements.'' \342\ By implication, 17.3 million individuals do not
                belong to a household,\343\ and live in group quarters.\344\ The
                Department assumed that the percentage of the U.S. population that is
                uninsured, 9%, is the same percentage of U.S. individuals belonging to
                U.S. households that are uninsured. To calculate the number of annual
                benefits notices, the Department added the total number of individuals
                that do not belong to a household (17.3 million) to the total number of
                households (117.7 million), and discounted the sum (135 million) by 9%
                to exclude those individuals who are not insured. The total number of
                annual notices of benefits that include a nondiscrimination notice and
                taglines is therefore approximately 123 million (approximately 91% of
                135 million).
                ---------------------------------------------------------------------------
                 \340\ Calculated by subtracting total uninsured population (28.1
                million as of 2016), See https://www.census.gov/library/publications/2017/demo/p60-260.html, from the total U.S. Population
                (327 million as of March 14, 2018), See https://www.census.gov/popclock.
                 \341\ The calculations do not take into account households where
                two or more unrelated persons have individual coverage, and thus
                receive separate annual notices at the same household. The
                Department believes, however, that this exclusion has only a minor
                impact on the overall figures.
                 \342\ U.S. Census Bureau, American Community Survey and Puerto
                Rico Community Survey 2016 Subject Definitions 76, https://www2.census.gov/programs-surveys/acs/tech_docs/subject_definitions/2016_ACSSubjectDefinitions.pdf (defining ``household'' under
                ``Household Type and Relationship'').
                 \343\ The Department subtracted 306 million individuals
                belonging to a household from the total U.S. population of 323.4
                million individuals. See U.S. Census Bureau, https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk (relied on 2016 population nationally).
                 \344\ U.S. Census Bureau, American Community Survey and Puerto
                Rico Community Survey 2016 Subject Definitions 76, https://www2.census.gov/programs-surveys/acs/tech_docs/subject_definitions/2016_ACSSubjectDefinitions.pdf (``People not living in households
                are classified as living in group quarters.''). ``Group quarters
                include . . . college residence halls, . . . skilled nursing
                facilities, . . . correctional facilities, and workers'
                dormitories.'' U.S. Census Bureau, 2016 American Community Survey/
                Puerto Rico Community Survey Group Quarters Definitions, 1 https://www2.census.gov/programs-surveys/acs/tech_docs/group_definitions/2016GQ_Definitions.pdf.
                ---------------------------------------------------------------------------
                 To estimate the volume of notices and taglines that accompany
                communications from the health insurance Exchanges, the Department
                assumes the Exchanges send communications to the 11.8 million
                individuals enrolled in the individual market.\345\ It assumes that the
                Exchanges send out approximately 1.5 notices per person per year. This
                accounts for the annual re-enrollment communication plus additional
                communications Exchanges will send for special enrollment periods.
                Thus, the total estimated volume of notices and taglines attributable
                to the Exchanges is 17.7 million.
                ---------------------------------------------------------------------------
                 \345\ See CMS, Health Insurance Exchanges 2018 Open Enrollment
                Period Final Report (Apr. 3, 2018), https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-04-03.html.
                ---------------------------------------------------------------------------
                 To estimate the volume of notices and taglines that accompany
                hospital bills and explanations of benefits sent by insurance companies
                (or health plans) for hospital admissions, the Department first
                estimated the total number of hospital bills and explanation of
                benefits that would be sent to patients annually. There are 35 million
                hospital admissions per year.\346\ For the purpose of this estimate,
                the Department assumes that each admission generates three bills from
                one hospital visit--each of which would include a notice and taglines
                document, for a total of 105 million bills, assuming three bills per
                admission.\347\ The Department assumes that 10% of the 105 million
                bills will have a notice and taglines document attached, for a total of
                10.5 million notice and taglines documents.
                ---------------------------------------------------------------------------
                 \346\ CDC, Chartbook on Long-Term Trends in Health (2016),
                http://www.cdc.gov/nchs/data/hus/hus16.pdf#317.
                 \347\ The Department presumes one hospital visit likely will
                generate a bill from the physician and two bills from any
                combination of services, such as anesthesia, ambulance service,
                imaging/radiology, or laboratory or blood work.
                ---------------------------------------------------------------------------
                 For patients who were insured upon admission to the hospital, in
                addition to the three hospital bills they would receive (on average),
                they would receive three associated explanations of benefits from their
                insurer or health plan, each of which would also include notice and
                taglines documents. If more than three service providers bill a patient
                for a hospital visit, then the savings associated with this patient
                encounter will be greater than estimated due to the additional notice
                and taglines documents that the insurer would send with each additional
                explanation of benefits beyond the initial three assumed. If fewer than
                three service providers bill for a hospital visit, then the savings
                will be less due to the decreased volume of notice and taglines
                documents that the insurer would send because the insurer would send
                fewer than three explanation of benefits. Given that approximately 91%
                of the U.S. population is insured, the
                [[Page 37229]]
                Department estimates that approximately 32 million of the 35 million
                hospital admissions are associated with insured patients (91% of 35
                million hospital admissions).\348\ This assumption does not account for
                variation in healthcare consumption between the insured and uninsured
                populations. It is possible that more hospital admissions are
                attributable to the uninsured than the insured population. If such is
                the case, the Department's estimate for the number of notices and
                taglines attributable to explanations of benefits would be lower.
                Further, this estimate does not account for outpatient hospital visits,
                which would increase the volume of notices and taglines. Moreover, if
                the elderly, nearly all of whom are insured by Medicare, make up a
                disproportionate share of hospital admissions, the Department's
                estimate for the number of notices and taglines attributable to
                explanations of benefits would be higher.
                ---------------------------------------------------------------------------
                 \348\ Calculated by subtracting total uninsured population (28.1
                million as of 2016), See https://www.census.gov/library/publications/2017/demo/p60-260.html, from the total U.S. Population
                in 2016 (323,405,935), See https://www.census.gov/popclock. http://news.gallup.com/poll/225383/uninsured-rate-steady-fourth-quarter-2017.aspx?g_source=Well-Being&g_medium=newsfeed&g_campaign=tiles.
                ---------------------------------------------------------------------------
                 As discussed further below, the Department assumes 100% of
                insurance companies are compliant with the notice and taglines
                requirement. Thus, approximately 96 million notice and taglines
                documents are attributable to the explanations of benefits sent by
                insurers (32 million admissions times three explanation of benefits).
                Using rounded values, approximately 107 million additional notices and
                taglines (96 million plus 11 million) are related to hospital
                admissions.
                 To estimate the volume of notices and taglines that accompany
                doctor's bills and explanations of benefits from a physician's visit,
                the Department relied on data showing that individuals visit
                physicians' offices approximately 990 million times each year.\349\
                Given that approximately 9% \350\ of Americans are uninsured, the
                Department assumes (and subtracting an estimated 5% for uninsured
                patients who do not visit the doctor, except in an emergency) that 95%
                of individuals who see doctors every year are insured in some form. The
                Department assumes that each visit to a compliant doctor's office will
                generate at least one bill from the doctor and at least one explanation
                of benefits from the health insurance company. As explained below, it
                also assumes that 10% of doctors and 100% of insurance companies comply
                with the notice and taglines requirement. Thus, approximately 99
                million notices and taglines are attributable to doctors billing the
                patients directly, and approximately 941 million are attributable to
                explanations of benefits sent by insurers, which results in a total of
                1.04 billion additional notices and taglines related to physician
                visits.
                ---------------------------------------------------------------------------
                 \349\ CDC, Ambulatory Care Use and Physician Office Visits
                (2016), https://www.cdc.gov/nchs/fastats/physician-visits.htm. As
                noted above, the Department relies on the 2016 RIA assumption that
                virtually all doctors receive Federal financial assistance and,
                thus, are subject to the 2016 Rule.
                 \350\ Calculated by subtracting total uninsured population (28.1
                million as of 2016), See https://www.census.gov/library/publications/2017/demo/p60-260.html, from the total U.S. Population
                in 2016 (323,405,935), See https://www.census.gov/popclock.
                ---------------------------------------------------------------------------
                 Because experience and substantial feedback from healthcare
                insurers suggests a very high degree of compliance with the notice and
                taglines requirements when it comes to documents such as explanations
                of benefits, the Department presumes 100% compliance for purposes of
                this RIA. Anecdotal evidence, however, suggests that hospital and
                physician compliance with the notice and taglines requirements in the
                documents discussed above is not standard industry practice. The
                Department estimates that, at most, 10% of such covered entities
                include notices and taglines in their significant mailed communications
                with patients. Although, according to the 2016 Rule's RIA, most
                hospitals and physicians are covered entities under Section 1557, the
                Department believes their failure to adopt notices and taglines as a
                standard billing and communication practice may be due to the fact the
                notice and taglines requirement in the 2016 Rule mentions a duty to
                notify ``beneficiaries, enrollees, applicants, and members of the
                public'' and does not explicitly mention ``patients.'' 45 CFR 92.8(a).
                Additionally, the preamble to the 2016 Rule explained that the notice
                and taglines requirement covered communications ``pertaining to rights
                or benefits,'' which insurance companies have universally interpreted
                as applying to significant numbers of communications they send to
                beneficiaries. 81 FR at 31402. For these reasons, the Department's
                calculations presume a 10% compliance rate for hospitals and physicians
                and a 100% compliance rate by health insurance companies concerning the
                notice and taglines requirement as it relates to bills and explanations
                of benefits, respectively.
                 To estimate the volume of notices and taglines that accompany
                pharmacy-related communications, the Department relied on estimates
                from the Pharmaceutical Care Management Association, which, due to the
                nature of its organization, obtained an estimated number of impacted
                beneficiaries from its member organizations. Approximately 173 million
                beneficiaries are being impacted annually by the notice and taglines
                requirement, and these beneficiaries receive between 6 and 28
                communications per year with an accompanying notice and taglines. The
                Department relied on the average of this estimate (17 communications
                per year per beneficiary) to determine that 2.9 billion prescription-
                related communications (e.g., communications from pharmacy benefit
                managers) are sent each year.\351\
                ---------------------------------------------------------------------------
                 \351\ Source: Pharmaceutical Care Management Association (May 2,
                2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0006.
                ---------------------------------------------------------------------------
                 To calculate the costs of the notice and taglines requirement, the
                Department assumes that the underlying communication to which a
                nondiscrimination notice and taglines document is attached is a
                communication that is on average three sheets of paper or less.
                Combined with the nondiscrimination notice and taglines (which
                constitute another 1-4 sides of a page, that is, 1 sheet single-sided
                \352\ to 2 sheets of paper double-sided), the total number of sheets of
                paper that would be transmitted is equivalent to 4-5 sheets of paper or
                less. The associated costs of the notice and taglines requirement are
                (1) materials, (2) postage, and (3) labor. Because of the uncertainty
                around some of the estimates, we report ranges for some values in this
                analysis.
                ---------------------------------------------------------------------------
                 \352\ Although this cost-benefit analysis assumes a lower-bound
                estimate that a notice of nondiscrimination and 15 taglines may be
                printed on one side of one sheet of paper, the Department believes
                that a notice of that length is likely noncompliant with the 2016
                Rule requirement to be posted ``in conspicuously-visible font
                size.'' See also OCR, Sample Notice Informing Individuals About
                Nondiscrimination and Accessibility Requirements and Sample
                Nondiscrimination Statement: Discrimination is Against the Law
                (printed on two sides of one sheet of paper), https://www.hhs.gov/sites/default/files/sample-ce-notice-english.pdf.
                ---------------------------------------------------------------------------
                 For materials, the Department assumes that materials (paper and
                ink) per notice and taglines mailing insert will cost between $0.025
                and $0.10. The Department assumes that low materials cost would be
                $0.025 to print a 1-page notice and taglines on a single sheet of paper
                single-sided, and the high materials cost of $0.10 to print a 4-page
                notice and taglines on 2 sheets of paper double sided.
                 For postage, the Department estimates that the additional weight of
                the notice
                [[Page 37230]]
                and taglines inserts result in a range of no incremental postage costs
                (low-end) to $0.21 per mailing (high-end). For instance, if an
                underlying communication is three sheets of paper or less, a covered
                entity's inclusion of one double-sided page (or shorter) of notice and
                taglines insert would likely weigh one ounce or less (approximately
                four letter-sized pages weigh one ounce).\353\ Consequently, in this
                scenario, the notice and taglines insert would not increase the total
                weight of the mailing beyond the one ounce of postage that a covered
                entity would already expect to incur. If, however, a covered entity
                included 2 sheets of paper double-sided containing the
                nondiscrimination notice and taglines, added to a communication of
                three sheets of paper or more, the total weight of the mailing would
                likely be at least five sheets of paper, and therefore over one ounce.
                The marginal cost of postage for each ounce is $0.20.\354\
                ---------------------------------------------------------------------------
                 \353\ See ``How Many Sheets of Paper Fit in a 1 Ounce Envelope
                for Mailing Purposes,'' https://www.reference.com/business-finance/many-sheets-paper-fit-1-ounce-envelope-mailing-purposes-84ba93a60789c2e1.
                 \354\ See U.S. Postal Service Postage Rates, https://www.stamps.com/usps/current-postage-rates/.
                ---------------------------------------------------------------------------
                 For labor, the Department estimates the burden to download, print,
                and include these notices and taglines with all significant
                communications for an office clerk (Occupation Code No. 43-9061) with a
                mean hourly wage of $16.92/hour \355\ plus an additional $16.92/hour in
                fringe benefits, or $33.84/hour for labor costs.\356\ Based on
                experience, entities can manually fold and insert notices and taglines
                into envelopes at a rate of approximately 360 per hour. Entities that
                use commercial machines can fold and insert notices and taglines as
                fast as 5,400 envelopes per hour.\357\ The Department uses the average
                of 2,880 notices and taglines that can be folded and placed into an
                envelope in an hour. Under these assumptions, the unit labor cost per
                notice and taglines mailing is $0.01.
                ---------------------------------------------------------------------------
                 \355\ BLS, Occupational Employment and Wages (May 2018), https://www.bls.gov/oes/2018/may/oes_nat.htm.
                 \356\ CMS estimates that the labor costs would be a one-time
                cost of $16,244 for Medicaid managed care and a one-time cost of
                $9,669 for CHIP managed care. The Department assumes for its
                calculations that the labor costs for the notice and tagline
                provisions are not one-time but are ongoing costs associated with
                the value of office clerks' time printing and including the notices
                and taglines with significant publications and significant
                communications.
                 \357\ See, e.g., Pitney Bowes, ``Folders and Inserters,''
                https://www.pitneybowes.com/nz/folders-inserters.html.
                ---------------------------------------------------------------------------
                 Considering materials, postage, and labor, the per-unit cost for
                the notice and taglines insert ranges from $0.035 at the low end (for
                one single-sided sheet of paper of notice and taglines) to $0.32 at the
                high end (for two double-sided sheets of paper of notice and taglines),
                if the Department assumes that the average underlying mailer is 3
                sheets of paper.
                 In addition, the Department estimates that some of these costs
                would be mitigated absent this final rule, due to transitions to
                electronic delivery for some communications affected by the 2016 Rule.
                The Department estimated, in the RIA for the Proposed Rule, that
                electronic delivery would reduce costs of affected communications by
                approximately 10-20% absent this final rule, shifting linearly from 10%
                in the first year to 20% in the fifth year following implementation (in
                other words, increasing by 2.5 percentage points each year). Survey
                results from Cognizant \358\ indicate that 70 percent of respondents
                consider it important to be able to view medical care-related
                statements (e.g., explanation of benefits documents) electronically,
                and that 42 percent are able to do so currently. But the same survey
                found that ``[a]doption rates are low for the digital services
                currently offered by health insurers, even for those that respondents
                rated as very important,'' with ``just about half of the members who
                were aware of'' a given digital service having actually ``used it.''
                According to another survey by InstaMed,\359\ 23% of providers offer
                some electronic billing, but even out of those providers who do, 58%
                still provide fewer than half of their bills electronically.\360\
                Moreover, it is likely that younger generations are the ones currently
                enrolling in e-statements; given that a disproportionate amount of
                health care services and products, especially pharmaceuticals, are
                consumed by the elderly, the communications containing the notices and
                taglines affected by this rule may be relatively unlikely to use e-
                statements. Therefore, as one end of a range of electronic delivery
                estimates, the Department maintains the earlier assumption of 10
                percent in the first year, growing linearly to 20 percent in the fifth
                year after finalization, and departs from the preliminary RIA's
                assumption only in that the linear growth is extended past the fifth
                year. At the opposite end of the range of estimates, the electronic
                delivery rate is assumed to be 21 percent upfront (reflecting the
                higher of the two survey results cited above, with adjustment to
                account for the fact that in those surveys, 50% or less of patients
                offered electronic delivery have been accepting it) and 42 percent in
                Year 5 (reflecting the same survey, without such adjustment), with
                subsequent increases continuing at 5.25 percentage points per year.
                ---------------------------------------------------------------------------
                 \358\ See https://www.cognizant.com/InsightsWhitepapers/The-Digital-Mandate-for-Health-Plans-codex1760.pdf.
                 \359\ See https://www.instamed.com/white-papers/trends-in-healthcare-payments-annual-report/.
                 \360\ See https://www.cognizant.com/InsightsWhitepapers/The-Digital-Mandate-for-Health-Plans-codex1760.pdf and https://www.instamed.com/white-papers/trends-healthcare-payments-report-2018/.
                ---------------------------------------------------------------------------
                 In combining the two input ranges for Table 2 below--the cost per
                printed and mailed communication and the electronic delivery rates--the
                low ends are used together and the high ends are used together, to
                reflect that entities facing relatively high costs for printed
                communications would have greater incentive to shift to electronic
                delivery where feasible. The primary estimates relied on for Table 1,
                however, use simply the midpoint of each of the two input ranges.
                 Electronic delivery would eliminate postage costs, but may to a
                certain extent merely shift the costs of paper and printing from the
                entity providing the communication to the consumer/beneficiary/patient,
                given that some consumer/beneficiary/patient recipients of electronic
                communications will print them out and incur costs for the paper and
                ink associated with doing so. The Department has not included such
                consumer/beneficiary/patient costs in its estimates.
                 The Department averages the low and high-end estimates to determine
                a primary estimate of annual cost savings, which results in average
                savings of approximately $0.58 billion per year, over the first five
                years, after adjusting for electronic delivery.
                 As discussed above, the proposed rule noted that, with repeal of
                the 2016 Rule requirements, the Department assumed that two other
                regulatory requirements for taglines would also be fully repealed
                because they depend on, or refer to, the 2016 Rule for authority for
                the taglines requirement. The first is the requirement placed on Health
                Insurance Exchanges (see 45 CFR 155.205(c)(2)(iii)(A)), which the
                Department estimates issue 17.7 million communications per year,
                primarily through eligibility and enrollment communications. The second
                is the requirement placed on QHP issuers (see HHS Notice of Benefit and
                Payment Parameters for 2016; 2016 Rule, 80 FR 10750, 10788 (Feb. 27,
                2015)), whose costs are incorporated into the volume calculations for
                annual notices of benefits, and explanations of benefits discussed in
                more detail above. Those
                [[Page 37231]]
                two other regulations have not yet been amended in this respect, but
                the Department clarified above that because those requirements inform
                entities they will be deemed in compliance if they are in compliance
                with the Section 1557 rule's notice and taglines requirement, and
                because the latter has now been repealed by this final rule, covered
                entities do not need to independently comply with those two other
                regulatory requirements cross referencing the Section 1557 rule. As a
                result, these estimates continue to assume this final rule will result
                in cost savings with respect to those requirements.
                 The Department also assumes that health insurance entities would
                not voluntarily append notices and taglines to routine monthly premium
                statements absent the 2016 Rule, but are doing so because of it (or
                because of a requirement in another regulation that bases its
                requirement on the 2016 Rule's requirement).
                 Table 2--Annual Savings From Repeal of Requirement To Publish and Mail Notices and Taglines, by Volume of
                 Transactions per Type per Year After Accounting for Electronic Delivery
                 [in millions]
                ----------------------------------------------------------------------------------------------------------------
                 Estimated low Savings Estimated high savings
                 Count ($0.035/unit) ($0.32/unit)
                ----------------------------------------------------------------------------------------------------------------
                Exchange eligibility and enrollment 17.7 Year 1: $1................ Year 1: $4.
                 communications. Year 5: $0................ Year 5: $3.
                Annual notice of benefits............... 123 Year 1: $4................ Year 1: $31.
                 Year 5: $3................ Year 5: $23.
                Explanations of Benefits--hospital 96 Year 1: $3................ Year 1: $24.
                 admissions. Year 5: $3................ Year 5: $18.
                Explanations of Benefits--physician's 941 Year 1: $30............... Year 1: $238.
                 visits. Year 5: $26............... Year 5: $175.
                Medical bills--hospital admissions...... 11 Year 1: $0................ Year 1: $3.
                 Year 5: $0................ Year 5: $2.
                Medical bills--physician visits......... 99 Year 1: $3................ Year 1: $25.
                 Year 5: $3................ Year 5: $18.
                Pharmacy-related notices................ 2,900 Year 1: $91............... Year 1: $733.
                 Year 5: $81............... Year 5: $538.
                 -----------------------------------------------------------------------
                 Total, accounting for electronic 4,188 Year 1: $132.............. Year 1: $1,059.
                 communications. Year 5: $117.............. Year 5: $777.
                ----------------------------------------------------------------------------------------------------------------
                 The primary estimate of annual savings is approximately $0.63
                billion in Year 1 and $0.51 billion in Year 5 after accounting for
                electronic delivery. The Department assumes that the nine other CMS
                regulations or guidelines requiring taglines will continue to be in
                effect, and the cost of complying with these CMS requirements would
                need to be subtracted from the total savings that the 2016 Rule's
                rescission generates for the healthcare sector as set forth in Table 2.
                These requirements include (1) Group Health Plans and Health Insurance
                Issuers requirements; \361\ (2) Navigator requirements; \362\ (3) Non-
                Navigator Assistance Personnel requirements; \363\ Medicaid
                requirements; \364\ Medicaid Managed Care requirements; \365\ CHIP
                requirements; \366\ CHIP Managed Care requirements; \367\ Hospitals
                Qualifying for Tax-Exempt Status requirements; \368\ and Medicare
                Advantage (Part C) and Prescription Drug Plans (Part D)
                requirements.\369\
                ---------------------------------------------------------------------------
                 \361\ 45 CFR 147.136(e)(2)(iii) and (e)(3), and Sec.
                147.200(a)(5).
                 \362\ 45 CFR 155.215(c)(4).
                 \363\ 45 CFR 155.215(c)(4).
                 \364\ 42 CFR 435.905(b)(3).
                 \365\ 42 CFR 438.10(d)(2) through (3), (d)(5)(i) and (iii), and
                (j).
                 \366\ 42 CFR 457.340(a).
                 \367\ 42 CFR 457.1207.
                 \368\ 26 CFR 1.501(r) through 1(b)(24)(vi).
                 \369\ Medicare Marketing Guidelines Sec. 30.5.1, https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/FinalPartCMarketingGuidelines.html.
                ---------------------------------------------------------------------------
                 Comment: Some commenters indicated that the notice and taglines
                requirements that the Department proposed for removal led to
                substantial costs that the Department understated. For example, they
                contended costs may be higher than the Department estimated in the
                proposed rule because plans had to revise internal documents, incur
                significant IT costs, and work with outside vendors to implement the
                2016 Rule. Commenters also contended the 2016 Rule resulted in
                significant annual printing costs.
                 One commenter calculated that the costs of the mailings related to
                pharmacy services yielded additional costs of $1 billion a year. The
                commenter supported the Proposed Rule's RIA aggregate estimate that the
                requirement would save plans $101 to $928 million a year and provided a
                specific example in which an affected entity reported incurring $3.9
                million in printing costs and $4 million in operations costs to send
                55.5 million communications.
                 Another company reported almost $1 million in annual increased
                expenses on toner, developer, paper, and postage related to notice and
                taglines requirements. Another commenter stated the costs associated
                with complying with the 2016 Rule's requirement accounts for 4.5% of
                one company's budgeted operating income. Some commenters also stated
                the proposed rule would significantly reduce the administrative burden
                placed on providers, saying that what constitutes a ``significant''
                communication has been insufficiently clear and has resulted in broad
                interpretations and providers using the taglines in almost every
                document.
                 Some commenters estimated that the dental profession has spent over
                $240 million to date on compliance with the 2016 Rule. The commenter
                noted that the time and cost for dental offices to interpret the
                regulations, print documents, alter existing publications, and modify
                websites has been significant. Several dental offices believe repealing
                the notice and taglines requirements will lead to cost savings and will
                allow staff to spend time on appropriate patient care and communication
                instead.
                 One commenter explained that in its Pennsylvania line of business,
                it serves
                [[Page 37232]]
                800,000 persons and sends them 2-page double-sided notices and taglines
                6,205,000 times a year under the 2016 Rule, resulting in $245,175 in
                annual mailing costs. The commenter noted it has similar experiences in
                all of its Medicaid lines of business.
                 Other commenters suggested the Department overestimated the costs
                of the 2016 Rule's notice and taglines requirements. One association
                stated that the Department's estimate in the proposed rule
                overestimated by failing to account for notices generated by a machine,
                included in bulk mailings, or facilitated through the use of computers.
                The commenter also believed that, while electronic delivery would
                eliminate postage costs, it would not shift the cost of paper and
                printing to the consumer/beneficiary/patient, stating it is unlikely
                that a significant percentage of individuals would download and print
                documents sent to them electronically. Similarly, the commenter
                contended the Department failed to account for the significant degree
                to which communications can be provided electronically and the degree
                to which some entities, such as insurance plans, have already been
                doing so for years.
                 Another commenter, however, agreed with OCR's calculation that the
                notice and taglines requirement has resulted in the inclusion of one to
                two sheets of paper. Similarly, one commenter stated it implemented
                multiple versions of the two-page notice and taglines on thousands of
                documents in its businesses, which consumed significant resources. The
                commenter noted that the requirements also impacted covered entity
                partners as well, particularly print vendors.
                 Some commenters asked the Department to separate out costs for
                providing notices as distinct from providing taglines, and for posting
                notices as distinct from mailing them.
                 Response: The Department appreciates the comments regarding the
                costs of the 2016 Rule's notice and taglines requirements. The
                Department agrees with commenters who contend that the requirements
                imposed significant and costly burdens far beyond the estimates set
                forth in the 2016 Rule. The Department finalizes this rule in
                significant part to relieve those burdens.
                 Some commenters contended the Department's estimates in the
                proposed rule were understated, and others contended the Department's
                estimates were overstated. The comments generally provided data from
                specific entities or circumstances.
                 The Department's estimate of the average cost of mailings is based
                on data received from covered entities across the affected industry,
                and generally takes into account processes and methods used in mailings
                such as machines, computers, and bulk handling. Although the Department
                suggested that some patients and beneficiaries might print notices
                electronically mailed to them, the Department did not factor those
                potential costs in its estimate. To the extent that commenters
                contended the Department failed to consider the extent to which notices
                and taglines are delivered electronically, this is incorrect, as the
                Department's preliminary estimates included downward adjustments to its
                estimates based on electronic delivery, and its revised estimates
                reflect a broader range of potential electronic delivery rates.
                Moreover, other commenters contend that they continue to experience
                significant costs based on non-electronic delivery--contending in some
                cases that the Department's estimates of those costs were understated.
                 Commenters were correct to identify that some costs, such as
                revising internal documents, IT costs, and setting up relationships
                with outside vendors, resulted from the 2016 Rule. The Department does
                not estimate that this final rule will lead to cost savings with regard
                to those types of expenses, however, because they are generally sunk
                costs that covered entities incurred at the time of the 2016 Rule and
                will not be able to recover as a result of this final rule. This final
                rule does not prohibit entities from continuing to provide the type and
                number of notices and taglines required by the 2016 Rule, but gives
                covered entities the flexibility to not provide them.
                 The Department declines to accept the suggestion of some commenters
                that the Department separate out the costs of notices from the costs of
                taglines. Information from covered entities indicates that notices and
                taglines are usually provided together, often on overlapping pages.
                Because this final rule removes both requirements, the Department's
                estimates are intended to cover the costs of both notices and taglines.
                 Comment: One commenter stated that the Department improperly relied
                on healthcare corporations for its fact-finding and analysis in the
                proposed rule. In particular, conclusions that the repetitive nature of
                notices and taglines dilute messages, that beneficiaries do not want to
                receive them, and that there is no evidence that more beneficiaries
                have sought language assistance because of the notices, were largely
                gathered from the covered entities themselves.
                 Response: The Department relies on its own data, publicly available
                data, and data submitted by members of the public--including covered
                entities--to attempt to estimate the impact of its regulations. The
                Department takes into consideration the sources of the data it
                considers, and attempts to weigh all such data appropriately based on
                the information the Department has available to it.
                f. Costs Arising From Removal of Notice and Taglines Requirement
                 Repealing the notice and taglines requirement may impose costs,
                such as decreasing access to, and utilization of, healthcare for non-
                English speakers by reducing their awareness of available translation
                services.
                 Comment: Some commenters generally supported the Department's
                assessment that the benefits from the notice and taglines requirements
                were hard to quantify and likely not significant. A health insurance
                plan commenter stated that since the implementation of the 2016 Rule,
                it has not experienced significant changes in its member demographics
                or languages spoken, and has not seen any notable increases in requests
                for translation services. One commenter also stated that its pharmacy
                benefit manager found that since 2017, the volume of valid complaints
                about discrimination are less than 1% overall and could be better
                handled by personnel already in place. The commenter stated further
                that since 2017, it has filled approximately 3.5 billion prescriptions
                and mailed nearly half a billion beneficiary communications. In this
                time period, approximately 0.002% (26 of 14,000) of calls made to the
                discrimination hotline were closely related to a complaint. Several
                commenters stated they did not see a significant increase in requests
                after the 2016 Rule required notices and taglines, but instead
                experienced relatively flat demand.
                 Some commenters also expressed concerns regarding wastefulness of
                the notice and taglines. A commenter calculated that it has spent
                nearly $16 million since 2017 to accommodate the current requirements
                and will save at least $3.5 million annually under the proposed rule.
                One commenter suggested that an analysis of the impact of the notice
                and taglines should take into account the content and frequency of the
                notices, overall consumer health literacy, costs and administrative
                burdens, and whether notices are truly meaningful to consumers.
                [[Page 37233]]
                 Other commenters suggested that the 2016 Rule's notice and taglines
                requirements likely yielded benefits to intended individuals. A
                hospital commented that it observed a 10% increase in the volume of
                interpreter service encounters each year over the last three years.
                Another commenter stated that it saw a 28% reduction on its per-member
                per-month claims cost with its Spanish-speaking population. Several
                commenters from a variety of organizations request an analysis of the
                impact on those who most use the services affected by the proposed
                provision (LEP individuals) and on those who provide services to the
                impacted population. Several organizations, including a State
                government, also contended that LEP individuals are a significant
                portion of the population and tend towards poorer health outcomes. They
                also suggested that removing the notice and taglines requirements may
                cause such individuals to delay care or not receive care until their
                medical issues are more severe and costlier to treat, and they urged
                the Department to estimate such costs.
                 Another commenter stated that even though HHS justified the
                proposed rule in part by citing data that over three-quarters of the
                U.S population over the age of 18 speak only English at home and are
                not well served by taglines or notices, the commenter believes that if
                a quarter of the population does not speak English at home that is an
                argument against repealing the notice and taglines.
                 Several commenters suggested repeal of the taglines provisions may
                negatively impact LEP individuals. One commenter cited a study claiming
                that health inequities cost the U.S. economy $309.3 billion a year.
                 Response: The Department appreciates the comments concerning the
                effectiveness and benefits of the notice and taglines requirements from
                the 2016 Rule. As noted in the proposed rule, previously received
                reports from covered entities are consistent with some public comments
                suggesting that the 2016 Rule's requirements did not appreciably
                increase the use of translation services. One such report indicated
                that utilization of translation services did not appreciably rise after
                the 2016 Rule's imposition of notice and taglines requirements.\370\
                Although some commenters contended that they experienced an increase in
                translation services after the 2016 Rule, others reported a different
                experience. The Department generally agrees with the latter, and the
                difference in reports from different commenters and other sources
                reinforces the Department's view of the difficulty of attempting to
                calculate the 2016 Rule's benefits to individuals needing translation
                services. The Department does not believe it has data enabling it to
                fulfill the request of commenters who urged the Department to calculate
                the value of such benefits lost as the result of this final rule, as
                distinct from data that more generally estimate costs resulting from
                inequality or delay in care.
                ---------------------------------------------------------------------------
                 \370\ See Aetna (May 1, 2017), available at https://www.regulations.gov/document?D=HHS-OCR-2019-0007-0005.
                ---------------------------------------------------------------------------
                 As noted in the proposed rule, there are other reasons to believe
                the 2016 Rule's notice and taglines requirements imposed burdens
                disproportionate to potential benefits for intended beneficiaries. The
                vast majority of recipients of taglines do not require translation
                services. For example, according to Census statistics, as of 2015, over
                three-quarters (79%) of the U.S. population over age five speak only
                English at home, followed by Spanish (13%).\371\ Although a commenter
                contends this statistic provides an argument in favor of maintaining
                multi-language taglines, the Department disagrees regarding a
                requirement to send such taglines where almost 80% of the recipients
                likely speak only English at home, and a majority of the remainder
                spoke English ``very well.'' \372\ Additionally, of persons selecting a
                written language preference when registering for coverage on the
                HealthCare.gov platform for 2017, 90.29% selected English, followed by
                8.23% who selected Spanish.\373\ These data indicate that, for the
                large majority of people who receive them, the required language
                taglines mailings provide little to no benefit because they are already
                proficient English speakers with little need for translation services.
                ---------------------------------------------------------------------------
                 \371\ U.S. Census Bureau, B16007: Age by Language Spoken at Home
                for the Population 5 Years and Over, 2011-2015 American Community
                Survey (American FactFinder) (2017), https://factfinder.census.gov/bkmk/table/1.0/en/ACS/16_5YR/S1601/0100000US. See also Kimberly
                Proctor, Shondelle M. Wilson-Frederick, et al., The Limited English
                Proficient Population: Describing Medicare, Medicaid, and Dual
                Beneficiaries, 2.1 Health Equity 87 (May 1, 2018), http://online.liebertpub.com/doi/10.1089/heq.2017.0036 (identifying Spanish
                as the language of the largest majority of limited English
                proficient speakers in Medicaid and Medicare, according to the 2014
                American Community Survey).
                 \372\ U.S. Census Bureau, B16007: Age by Language Spoken at Home
                for the Population 5 Years and Over, 2011-2015 American Community
                Survey (American FactFinder) (2017), https://factfinder.census.gov/bkmk/table/1.0/en/ACS/16_5YR/S1601/0100000US.
                 \373\ CMS, Race, Ethnicity, and Language Preference in the
                Health Insurance Marketplaces 2017 Open Enrollment Period (April
                2017), https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-Race-Ethnicity-and-Language-Preference-Marketplace.pdf. States that that do not use the HealthCare.gov
                platform, such as California and New York, were not included in this
                report.
                ---------------------------------------------------------------------------
                 Furthermore, the 2016 Rule's requirements added 47 languages to
                existing language access requirements, but that only increased access
                to 0.4% of the entire U.S. population. This was after broadly defining
                ``limited English proficiency'' to include those who speak English
                ``well'' but not ``very well.'' \374\ The Department's Office for Civil
                Rights also produced a list of the top 15 languages in each State;
                however, 26 of the languages on OCR's list are spoken by less than
                0.004 percent of the population. As a result, in some States,
                especially those with sparser populations, the 2016 Rule required
                health insurance issuers to provide taglines services in languages
                spoken by very few people in the State. For instance, in Wyoming,
                issuers needed to provide translation notices in Gujarati and Navajo in
                every significant communication sent to beneficiaries to account for
                approximately 40 Gujarati speakers and 39 Navajo speakers; in Montana
                issuers were required to provide notices to account for approximately
                80 speakers of Pennsylvania Dutch; and in Puerto Rico, issuers had to
                provide taglines notices to account for approximately 22 Korean
                speakers and 22 French Creole speakers.\375\
                ---------------------------------------------------------------------------
                 \374\ See HHS OCR, Frequently Asked Questions to Accompany the
                Estimates of at Least the Top 15 Languages Spoken by Individuals
                with Limited English Proficiency under Section 1557 of the
                Affordable Care Act, Question 2 (Sept. 1, 2016), https://www.hhs.gov/civil-rights/for-individuals/section-1557/1557faqs/top15-languages/index.html (using 2013 year estimates). See U.S.
                Census Bureau, Language Spoken at Home by Ability to Speak English
                for the Population 5 Years and Over, https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ACS_14_5YR_B16001&prodType=table (2016 year
                estimates).
                 \375\ OCR, Resource for Entities Covered by Section 1557 of the
                Affordable Care Act, Estimates of at Least the Top 15 Languages
                Spoken by Individuals with Limited English Proficiency for the 50
                States, the District of Columbia, and the U.S. Territories (Aug.
                2016), https://www.hhs.gov/sites/default/files/resources-for-covered-entities-top-15-languages-list.pdf.
                ---------------------------------------------------------------------------
                 The Department also continues to believe that the notice and
                taglines required by the 2016 Rule imposed burdens on many recipients
                and may interfere in their receipt and understanding of important
                healthcare information. Prior to the proposed rule, the Department
                received many communications from beneficiaries and advocacy groups
                complaining about the excessive amount of paperwork they receive. These
                individuals and groups
                [[Page 37234]]
                explained that few people read the notice and taglines and most ignore
                the last pages of lengthy health documents. Additionally, documents
                that contain a significant number of pages that recipients do not value
                can often induce annoyance or frustration due to perceived wasting of
                time, ignorance of the customers' actual needs or language abilities,
                waste of economic resources, or insensitivity to environmental
                concerns.
                 These communications coincide with the views of some commenters and
                generally support the Department's conclusion that the 2016 Rule has
                resulted in ``cognitive overload,'' where individuals experience a
                diminished ability to process information when inundated with
                duplicative information and paperwork. These frustrations, though
                difficult to quantify, are reasonable to expect given the large volume
                of healthcare communications with notice and taglines that most
                Americans receive. It is also reasonable to expect that repeated
                mailings of taglines to people who do not want them may negatively
                impact their likelihood to read truly significant documents from their
                insurers or doctors, and may negatively impact health outcomes in some
                cases.
                 It is also noteworthy that other rules exist to benefit the persons
                whom the 2016 Rule's notice and taglines requirements intended to
                assist. Regulations under Section 504 of the Rehabilitation Act
                generally require the provision of auxiliary aids and services in
                health programs or activities that receive Federal financial
                assistance. 45 CFR 84.52(d). Because the notice requirement under the
                2016 Rule required frequent mailed notification of the availability of
                auxiliary aids and services, the Department suggested in the proposed
                rule that repealing the notice of nondiscrimination requirement may
                result in additional societal costs, such as decreased utilization of
                auxiliary aids and services by individuals with disabilities due to
                their reduced awareness of such services. Some commenters agreed, but
                they did not suggest any way to reliably calculate such effects, and
                the Department is not aware of any. This impact may also be limited
                because the Section 504 regulations already require recipients of
                Federal financial assistance employing fifteen or more persons to
                provide notice to participants, beneficiaries, applicants, employees,
                and other interested persons of the availability of such aids and
                services. 45 CFR 85.12 and Sec. 84.22(f).
                 Additionally, some commenters contended that repealing the notices
                and taglines may lead to persons not being made aware of their right to
                file complaints with OCR, and that some of those persons may suffer
                remediable grievances but will not complain to OCR absent notices
                informing them of the process. The Department continues, however, to
                not be aware of a way to quantify those potential effects. In addition,
                as noted above, the regulations implementing Section 1557's four
                underlying statutes already contain notice provisions, see 45 CFR 80.6
                and Appendix to Part 80 (Title VI), Sec. 84.8 (Section 504), Sec.
                86.9 (Title IX) and Sec. 91.32 (Age Act), and therefore this potential
                cost may be minimal.
                g. Cost Savings From Changes to Language Access Plan Provisions
                 Although the 2016 Rule did not require covered entities to develop
                a language access plan, the Rule stated that the development and
                implementation of a language access plan is a factor the Director
                ``shall'' take into account when evaluating whether an entity is in
                compliance with Section 1557. 45 CFR 92.201(b)(2). Therefore, the
                Department anticipated that 50% of covered entities would develop and
                implement a language access plan following issuance of the 2016 Rule.
                81 FR at 31454.
                 Comment: One commenter noted that physician group practices report
                financial losses and significant costs when treating patients that
                require interpretation or translation services. The commenter stated
                that providing reimbursement at the Federal level would help offset
                extra costs incurred to provide these services free of charge and
                reimburse group practices for increased upfront costs and time required
                to care for LEP individuals. The commenter contended that face-to-face
                interpretation services cost between $50 and $150 per hour and may
                include a minimum hour requirement and transportation fee. The
                commenter points to one practice that reported being billed nearly $300
                for a single in-person interpreter service this year due to a minimum
                rate and transportation fee. The practice reported paying $1,200 in
                interpretation fees for one month for nine individuals.
                 Response: The Department appreciates these comments. With respect
                to serving LEP patients, this final rule gives more flexibility to
                covered entities, while specific obligations to patients will be
                governed by criteria that has been set forth in longstanding
                guidelines. It is not within the scope of this rule to provide for
                Federal reimbursements.
                 Comment: Several commenters claim the proposed rule failed to
                consider the benefits to LEP individuals that will be lost by repealing
                certain provisions. Such commenters state there are tens of millions of
                LEP people who rely on protections from Section 1557. Another commenter
                notes that four million Medicare beneficiaries are LEP. A commenter
                notes that only 15 States use the Medicaid option to reimburse for
                interpretation. Commenters state that the language access protections
                in the 2016 Rule benefit Latino/a patients, Asian American and AAPI
                patients, LEP gender-based violence victims, low-income LEP patients,
                older adults, people with disabilities, and lower-income older adults.
                 Some commenters contend that the rule will lead to reduced
                awareness of language services by LEP persons and by the general public
                about their rights and protections. One commenter stated that if the
                rule is finalized, organizations like community health centers that are
                not funded or do not receive reimbursement for language services will
                face increased burdens when fewer clients will be aware of their
                language access rights and likely turn to them instead of to covered
                entities.
                 Commenters opposing the proposed rule claimed it would lead to
                inequality and a reduction in the quality of language access available;
                the avoidance of care, leading to worsened conditions and avoidable
                higher-cost hospital services; increased costs due to missed
                appointments, delayed care, and ``non-compliant'' self-care; increased
                Emergency Room use; lower preventive care access and use; malpractice
                costs; avoidable hospital readmissions; higher rates of uninsurance;
                unnecessary tests and procedures; higher rates of mortality;
                misunderstood diagnoses and prognoses leading to poor quality of care;
                and costs due to lower rates of outpatient follow-up, poor medication
                adherence, and lack of understanding of discharge diagnosis and
                instructions.
                 One commenter claimed that HHS's estimate that covered entities
                would save around $17.7 million per year by eliminating references to
                language access plans overlooks larger healthcare savings generated by
                access to interpretation services. Two commenters point to a 2017 study
                finding that easily accessible language interpretation services avoided
                an estimated 119 readmissions that were associated with savings of
                $161,404 per month in an academic hospital. Two commenters pointed to a
                2010 report finding that at least 35 of 1,373 malpractice claims were
                linked to inadequate language access.
                [[Page 37235]]
                 Another commenter cited a report that found that 2.5% of one
                malpractice carrier's closed claims involved language issues that cost
                the carrier over $5 million in damages, settlements, and legal fees.
                Costs included damages paid to patients, legal fees, time lost when
                defending the lawsuit, loss of reputation and patients, fear of
                possible monetary loss, and stress.
                 Response: The Department acknowledges the potential of reduced
                awareness of the availability of language services by LEP individuals
                by the changes made in this rule, or downstream effects on malpractice
                claims due to less awareness. As noted above, however, this final rule
                continues to provide protections for LEP individuals and commits the
                Department to enforcement of Section 1557. The Department believes,
                therefore, that the negative effects predicted by some commenters may
                be mitigated by the continued commitment to enforcement of Section
                1557. The data cited by commenters either do not assess the overall
                impact of the 2016 Rule as compared to a regime with continued
                enforcement of Section 1557, or address information about broader
                matters without providing a method for the Department to specifically
                analyze how this final rule will cause the effects commenters fear may
                occur. In this respect, the Department believes that malpractice
                carriers themselves, not Federal civil rights regulators, are best
                equipped to determine what practices malpractice carriers should
                require for the sake of reducing their own financial risk.
                 Therefore, in consideration of the public comments and the
                Department's analyses, the Department adopts the estimates from the
                proposed rule concerning changes to language access plan provisions.
                 In the proposed rule, OCR estimated that the burden for developing
                a language access plan is approximately three hours of medical and
                health service manager staff time in the first year, and an average of
                one hour of medical and health service manager staff time per year to
                update the plan in subsequent years. Throughout, we assume that the
                total dollar value of labor, which includes wages, benefits, and
                overhead, is equal to 200 percent of the wage rate. The value of an
                hour of time for people in this occupation category, after adjusting
                for overhead and benefits, is therefore estimated to be $109.36 based
                on Bureau of Labor Statistics (BLS) data for 2018.\376\ These are
                within the general range provided by some commenters' description of
                costs they have experienced.
                ---------------------------------------------------------------------------
                 \376\ BLS, Occupational Employment and Wages (May 2018), https://www.bls.gov/oes/2018/may/oes_nat.htm.
                ---------------------------------------------------------------------------
                 The Department estimated that approximately 269,141 entities could
                potentially make changes and develop language access plans in response
                to the 2016 Rule, as part of the requirement to take reasonable steps
                to provide meaningful communication with LEP individuals (calculated by
                reducing the 275,002 affected entities by the 5,861 hospitals and
                nursing care facilities that were already subject to language access
                plan requirements under Medicare Part A). The Department further
                assumed that only 50% of the identified entities would actually make
                changes to implement a language access plan. If the actual compliance
                rate were higher, the costs would be higher. These assumptions imply
                that the total cost of developing language access plans will be
                approximately $44.1 million (269,141 entities multiplied by 50% of
                entities multiplied by 3 hours per entity multiplied by $109.36 per
                hour) in the first year and approximately $14.7 million (269,141
                entities multiplied by 50% of entities multiplied by 1 hour per entity
                multiplied by $109.36 per hour) per year in subsequent years. The
                Department assumes sunk costs cannot be recovered by this rule, and
                therefore that initial language access plan development costs
                attributable to the 2016 Rule cannot be recovered.
                 By repealing the provision of the 2016 Rule regarding the Language
                Access Plans, the Department estimates annual savings are $14.7
                million.
                h. Cost Savings Attributed to Covered Entities' Handling of Certain
                Grievances
                 This final rule repeals the requirement for each covered entity
                with 15 or more employees to have a compliance coordinator and a
                written grievance procedure to handle complaints alleging violations of
                Section 1557. The Department estimates that, under the final rule,
                covered entities no longer have to incur certain labor costs associated
                with processing grievances related to sex discrimination complaints as
                they relate to gender identity as defined under the 2016 Rule because
                such definitions would be repealed and no longer binding. This repeal
                would not, however, affect the independent obligations that entities
                covered by Section 1557 have to comply with Federal regulations under
                Section 504 and Title IX to have written processes in place to handle
                grievances alleging certain disability and sex discrimination claims,
                respectively.\377\
                ---------------------------------------------------------------------------
                 \377\ See, e.g., 45 CFR 84.7(a) (HHS regulations implementing
                Section 504) (requiring a written process to be in place for
                handling grievances alleging disability discrimination), Sec.
                86.8(a) (HHS regulations implementing Title IX) (requiring a written
                process to be in place for handling grievances alleging sex
                discrimination).
                ---------------------------------------------------------------------------
                 For the sake of consistency and convenience, the Department used
                the methodology from the 2016 Rule as a foundation for estimating the
                projected savings from this proposed rule provision.
                 The 2016 Rule estimated that, in years three through five of the
                2016 Rule's implementation, covered entities with 15 or more employees
                would incur $85.5 million in costs annually to handle Section 1557
                grievances. 81 FR at 31458. This estimate assumed that covered entities
                would experience an average increase in grievances equal to OCR's
                projected long-term increase in caseload of about 1%. Id. The 2016 Rule
                monetized this 1% increase in caseload as a labor cost equivalent to 1%
                of the annual median wage for a medical and health service manager
                (occupation code 11-9111). Id. The Department continues to assume that
                OCR's increase in caseload attributed to the 2016 Rule reasonably
                informs the increase in grievance processing that covered entities will
                experience.
                 Based on OCR's tracking of Section 1557 complaints received from
                promulgation of the 2016 Rule (May 18, 2016) until present, OCR
                predicts that its long-term caseload would have increased 5% rather
                than 1% as originally predicted. Further, OCR believes roughly 60% of
                this increase (which equals 3% of the overall increase) would have been
                attributable to discrimination claims based on the 2016 Rule's
                definition of sex discrimination with respect to gender identity and
                sex stereotyping. The Department uses the phrase ``would have'' with
                regard to OCR's caseload because, as described above, the Department
                has been preliminarily enjoined on a nationwide basis by a Federal
                court from enforcing claims based on the 2016 Rule's definition of sex
                discrimination, and those provisions have now been vacated by the same
                court.
                 The 2016 Rule asserted that private parties have the right to
                challenge a violation of Section 1557 or the 2016 Rule in Federal
                court, independent of OCR enforcement or involvement. 45 CFR 92.302(d).
                In the preamble to the 2016 Rule, the Department suggested that the
                ability for private parties to sue
                [[Page 37236]]
                under the 2016 Rule would result in covered entities bearing increased
                compliance costs. 81 FR at 31395 (``the presence of a coordinator and
                grievance procedure enhances the covered entity's accountability and
                helps bring concerns to prompt resolution, oftentimes prior to an
                individual bringing a private right of action.''). The preliminary
                injunction did not apply to suits filed by private parties. Although
                the Supreme Court has recognized a private right of action for some
                civil rights statutes enforced by the Department, under this final rule
                the Department would no longer assert in the regulatory text or the
                preamble to the rule that a private right of action exists for parties
                to sue covered entities for any and all alleged violations. Because the
                issue of whether a person has a right to sue in Federal court under
                Section 1557 is one determined by the courts themselves and not by the
                Department's regulations, the Department does not estimate that this
                change will lead to any economic impact.
                 Although this final rule removes from the 2016 Rule the expansive
                inclusion of gender identity and sex stereotyping in the definition of
                sex discrimination, a court has recently vacated the gender identity
                provisions of the 2016 Rule. Regarding sex stereotyping, to the extent
                the 2016 Rule used that term to encompass gender identity, the sex
                stereotyping provision had no real-world effect after the court
                decision. To the extent sex stereotyping in the 2016 Rule did not
                encompass gender identity, the Supreme Court already recognized a
                degree of relevance of sex stereotyping in sex discrimination claims.
                This is discussed in more detail in the section above on sex-based
                discrimination. Therefore, the Department does not believe there would
                be a direct material economic impact regarding grievance procedures
                from this final rule's change in the definitions concerning sex
                stereotyping.
                 In addition, due to voluntary policies or more stringent State
                requirements, the Department expects that 50% of covered entities would
                likely continue to accept and handle grievances alleging discrimination
                based on gender identity and sex stereotyping as set forth under the
                2016 Rule.
                 In the proposed rule, the Department estimated that covered
                entities would have experienced a 3% increase in gender identity and
                sex stereotyping grievance claims over the long term due to the 2016
                Rule, and half of that caseload (1.5%) could have been due to the 2016
                Rule's language encompassing gender identity and sex stereotyping
                claims in States where covered entities are not otherwise required to
                handle those claims. The proposed rule estimated an annual savings in
                labor attributed to a 1.5% decrease in grievance caseload as $123.4
                million, representing 1.5% of the annual median wage of a medical and
                health service manager ($199,472 fully loaded) multiplied by the 41,250
                covered entities with 15 or more employees.
                 Nevertheless, in this final rule the Department does not estimate a
                cost savings concerning grievance procedures. This is because, as
                stated repeatedly elsewhere, the court order vacating the gender
                identity provisions of the 2016 Rule means that this final rule's
                changes concerning gender identity will have no direct material
                economic impact. The Franciscan Alliance court order forms the new
                legal baseline in this respect, and therefore the primarily-emphasized
                economic baseline, for the purposes of this estimate. To the extent
                sex-stereotyping claims remain viable, they were already authorized by
                the Supreme Court's longstanding interpretation of sex stereotyping.
                i. Additional Costs for Training and Familiarization
                 To comply with the final rule, the Department anticipates that some
                covered entities may incur costs to re-train employees in order to
                realize potential longer-term costs savings from the deregulatory
                aspects of this final rule's changes. The Department assumes that
                employers are most likely to train employees who interact with the
                public, and will therefore likely train between 40% and 60% of their
                employees, as the percentage of employees that interact with patients
                and the public varies by covered entity. For purposes of the analysis,
                the Department assumes that 50% of the covered entity's staff will
                receive one-time training on the requirements of the regulation. It
                uses the 50% estimate as a proxy, given the lack of certain information
                as described below. For the purposes of the analysis, the Department
                does not distinguish between employees whom covered entities will train
                and those who obtain training independently of a covered entity.
                i. Number of Covered Entities That May Train Workers
                 The 2016 Rule estimated that 275,002 covered entities would train
                their employees on the rule's requirements in general (including
                training regarding language access provisions), and used that 275,002
                figure as the basis for calculating costs to covered entities arising
                specifically out of the rule's prohibition on discrimination on the
                basis of sex. See 81 FR at 31450. The Department assumes, for purposes
                of this analysis, that the 2016 Rule's estimate was an accurate and
                reasonable basis for calculating costs arising from the need to provide
                training regarding the 2016 Rule.
                 Table 3--Number of Healthcare Entity Firms Covered by Rule
                ------------------------------------------------------------------------
                 Number of
                 NAIC Entity type firms
                ------------------------------------------------------------------------
                62142.......................... Outpatient mental 4,987
                 health and substance
                 abuse centers.
                621491......................... HMO medical centers.... 104
                621492......................... Kidney dialysis centers 492
                621493......................... Freestanding ambulatory 4,121
                 surgical and emergency
                 centers.
                621498......................... All other outpatient 5,399
                 care centers.
                6215........................... Medical and diagnostic 7,958
                 laboratories.
                6216........................... Home healthcare 21,668
                 services.
                6219........................... All other ambulatory 6,956
                 healthcare services.
                62321.......................... Residential 6,225
                 intellectual and
                 developmental
                 disability facilities.
                6221........................... General medical and 2,904
                 surgical hospitals.
                6222........................... Psychiatric and 411
                 substance abuse
                 hospitals.
                6223........................... Specialty (except 373
                 psychiatric and
                 substance abuse)
                 hospitals.
                6231........................... Nursing care facilities 8,623
                 (skilled nursing
                 facilities).
                44611.......................... Pharmacies and drug 18,852
                 stores.
                6211........................... Offices of physicians.. 185,649
                524114......................... Insurance Issuers...... 180
                [[Page 37237]]
                
                 Navigator grantees..... 100
                 ---------------
                 Total Entities............. ....................... 275,002
                ------------------------------------------------------------------------
                ii. Number of Individuals Who Will Receive Training
                 The first category of healthcare staff that may receive training
                comprises health diagnosing and treating practitioners. This category
                includes physicians, dentists, optometrists, physician assistants,
                occupational, physical, speech and other therapists, audiologists,
                pharmacists, registered nurses, and nurse practitioners. The BLS
                occupational code for this grouping is 29-1000, and the 2018 reported
                count for this occupational group is approximately 5.4 million, with
                average loaded wages of $98.04 per hour.
                 The second category of healthcare staff that the Department assumes
                will receive training comprises degreed technical staff (Occupation
                code 29-2000) and accounts for 3.1 million workers with average loaded
                wages of $46.52 per hour. Technicians work in almost every area of
                healthcare: x-ray, physical, speech, psychiatric, dietetic, laboratory,
                nursing, and records technicians, to name but a few areas.
                 The third category of healthcare staff that the Department assumes
                will receive training comprises non-degreed medical assistants
                (Occupation code 31-0000), and includes psychiatric and home health
                aides, orderlies, dental assistants, and phlebotomists. Healthcare
                support staffs (technical assistants) operate in the same medical
                disciplines as technicians, but often lack professional degrees or
                certificates. The Department refers to this workforce as non-degreed,
                compared to medical technicians who generally have degrees or
                certificates. There are approximately 4.1 million individuals employed
                in these occupations, with average loaded wages of $31.14 per hour.
                 The fourth category of healthcare staff that the Department assumes
                will receive training is healthcare managers (approximately 0.4 million
                based on BLS data for occupation code 11-9111), with average loaded
                wages of $109.36 per hour. Because the Department assesses costs of
                familiarization with the regulation for one manager at each entity, it
                assumes that those managers will have already become familiar with the
                regulation and will not need additional training.
                 The fifth category of healthcare staff that the Department assumes
                will receive training is office and administrative assistants--Office
                and Administrative Support Occupation (Occupation code 43-0000). These
                workers are often the first staff patients encounter in a health
                facility and, because of this, covered entities might find it important
                that staff, such as receptionists and assistants, receive training on
                the regulatory requirements. Approximately 2.8 million individuals were
                employed in these occupations in health facilities in 2018, with
                average loaded wages of $36.50 per hour. The Department assumes that
                outreach workers are included in the five categories listed above,
                especially in the manager category.
                iii. Total Costs of Training
                 The 2016 Rule estimated that covered entities would incur $420.8
                million in undiscounted costs to train employees on the requirements of
                the Rule, distributed roughly evenly over the first two years after the
                2016 Rule's effective date. 81 FR at 31458. This conclusion presumed
                covered entities were already periodically training employees on their
                obligations under Section 1557, but that the 2016 Rule's new sex
                discrimination requirements would induce covered entities to engage in
                additional ``comprehensive training.'' 81 FR at 31447.
                 For the purposes of this regulatory impact analysis, the Department
                assumes covered entities would face similar costs to retrain the
                workforce on this final rule's requirements.\378\ However, because some
                covered entities will avoid incurring training expenses when they are
                not required to (as they will not be subject to the final rule), and
                because several States with large populations already prohibit gender
                identity discrimination in healthcare, the Department further assumes
                that only 50% of covered entities would modify their policies and
                procedures to reflect the changes in the final rule. Moreover, to the
                extent entities were motivated to provide training specifically due to
                the sex discrimination components of the 2016 Rule, a court has already
                vacated the gender identity and termination of pregnancy provisions of
                the 2016 Rule, and this final rule simply amends the Code of Federal
                Regulations to conform to the vacatur in that regard. The Department
                further assumes that 50% of covered entities, or 137,501, would train
                their employees to reflect the changes in this final rule. As in the
                2016 Rule, the Department assumes that approximately half of the
                employees at these covered entities will engage in an average of an
                additional hour of training, and that this will occur in the first year
                of implementing this rule. These assumptions imply total training costs
                of $235.9 million. The 2016 Rule's calculations of training costs did
                not anticipate any ongoing training costs after year one--either in the
                form of annual refresher training for returning employees or training
                for new employees. The Department now believes that covered entities
                likely incur such costs, but assumes that equal costs would also be
                incurred under this final rule. Therefore, the Department has excluded
                ongoing training costs from the calculation of the baseline and from
                the calculation of the projected costs of the proposed rule, because
                such training has a net zero effect on projected costs.
                ---------------------------------------------------------------------------
                 \378\ Training costs in the 2016 Rule relied upon 2014 wages.
                See, e.g., 81 FR at 31451 (estimating the median hourly wage for
                occupation code 29-1000 at $36.26, unloaded, at https://www.bls.gov/oes/special.requests/oesm14nat.zip .
                ---------------------------------------------------------------------------
                j. Additional Costs for Revising Policies and Procedures
                 As discussed above, the Department anticipates that 50% of covered
                entities, or approximately 137,501 entities, would choose to revise
                their policies or procedures to reflect this final rule's clarification
                of the application of Section 1557, while other covered entities may
                retain their policies to ensure compliance with State or local laws.
                The Department assumes that it would take, on average, three to five
                hours for a provider to modify policies and procedures concerning this
                final rule. The Department selects four hours, the midpoint of this
                range, for the analysis. The Department further assumes that an average
                of three of these hours would be spent by a mid-level manager
                equivalent to a first-line
                [[Page 37238]]
                supervisor (Occupation code 43-1011), at a cost of $57.06 per hour
                \379\ after adjusting for overhead and benefits, while an average of
                one hour would be spent by executive staff equivalent to a general and
                operations manager (Occupation code 11-1021), at a cost of $119.12 per
                hour \380\ after adjusting for overhead and benefits. The total cost
                for the estimated 137,501 covered entities to make their policies and
                procedures consistent with the final rule's changes is estimated to be
                approximately $39.9 million following implementation of this rule.
                ---------------------------------------------------------------------------
                 \379\ BLS, Occupational Employment and Wages, May 2018, https://www.bls.gov/oes/2018/may/oes_nat.htm.
                 \380\ Id.
                ---------------------------------------------------------------------------
                 The above estimates of time and number of entities that would
                choose to revise their policies under the regulation are approximate
                estimates based on general BLS data. Due to the wide range of types and
                sizes of covered entities, from complex multi-divisional hospitals to
                small neighborhood clinics and physician offices, the above estimates
                of time and number of entities that would choose to revise their
                policies under the regulation is difficult to calculate precisely.
                k. Other Benefits or Costs
                 The 2016 Rule's regulatory impact analysis did not include an
                economic cost-benefit analysis of the regulation's impact on health
                insurance benefit design. The Department lacks sufficient data on how
                much burden the 2016 Rule has placed on the development and operation
                of insurance benefits policies, and thus is unable to fully assess the
                benefit of removing this requirement.
                 The Department received several comments concerning the impact of
                the proposed rule on issues concerning discrimination on the basis of
                LGBTQ status, sex stereotyping, termination of pregnancy, and other
                provisions.
                 Comment: Many commenters objected that the Department did not
                estimate the potential for increases in the denial, delay, or
                substandard delivery of healthcare services from the rule's changes
                concerning gender identity.
                 One commenter suggested exploring quantitative analysis based on a
                survey by Harvard University and National Public Radio (NPR) in which
                18% of LGBTQ people polled in 2017 reported foregoing care that they
                need, including preventive care, due to fears of or experiences of
                discrimination (including 22% of transgender people).\381\ The comment
                estimated that this regulation will cost $1.4 billion in excess costs
                over the next ten years simply to treat cases of four particular
                cancers that would have been detected and prevented by screening, and
                that there will be an 18% increase in preventable mortality from these
                four cancers among LGBT people. The comment cited the 2016 value of a
                statistical life (VSL) used by the U.S. Department of Transportation to
                estimate these preventable deaths as being worth $39 billion to the
                U.S. economy over the next ten years.
                ---------------------------------------------------------------------------
                 \381\ NPR, ``Discrimination in America: Experiences and Views of
                LGBTQ Americans'' (Nov. 2017), available at https://www.npr.org/documents/2017/nov/npr-discrimination-lgbtq-final.pdf.
                ---------------------------------------------------------------------------
                 Another commenter provided a list of potential sources of economic
                costs the proposed rule could produce concerning transgender patients,
                including out-of-pocket costs shifted because of transgender
                exclusions; increased costs from healthcare issues exacerbated by
                discriminatory delay or denial of care; increased costs related to sex
                coding; or increased costs due to substandard delivery of care. Other
                commenters similarly contended that literature on increased costs due
                to discrimination could be used to estimate economic costs. But such
                commenters did not provide quantitative values of such costs, or of
                ways to attribute the costs or portions thereof to this rulemaking.
                 One healthcare provider stated that they have not incurred any
                unreasonable costs in delivering care to its LGBTQ patients from
                complying with nondiscrimination protections based on sexual
                orientation and gender identity. The commenter added that adopting
                transgender-inclusive healthcare practices can reduce the costs
                associated with complications that arise when care is delayed or denied
                transgender patients due to discrimination.
                 One commenter stated that patients without primary care would
                experience an increase in emergency room visits, which would result in
                increased costs for the healthcare system--including from hospitals'
                and the government's absorbing and subsidizing the costs of uninsured
                patients.
                 Commenters raised similar comments concerning sexual orientation as
                did the commenters discussing gender identity or LGBTQ issues more
                broadly, contending the proposed rule should estimate the impact of not
                including protections against sexual orientation discrimination.
                 Response: The Department appreciates the comments concerning the
                regulatory impact of this final rule's changes concerning gender
                identity.
                 This rule commits the Department to vigorous enforcement of the
                nondiscrimination provisions of Section 1557 and Title IX as
                incorporated therein, according to the plain meaning of the protections
                set forth in those statutes. In addition, the gender identity
                provisions of the 2016 Rule were preliminarily enjoined on a nationwide
                basis by a court from December 2016 until October 2019, when they were
                vacated entirely. As a result, this final rule maintains the status quo
                with respect to gender identity under the enforcement of the Section
                1557 rule.
                 Based on the Department's review of the public comments, the
                commenters did not provide, and the Department is not otherwise aware
                of, reliable data or methods to calculate the economic impacts
                concerning gender identity that they allege would be attributable to
                this final rule. Commenters cited various sources of data, but many
                were either too narrow in not providing a basis to estimate the impacts
                of this rule nationwide, or were too broad in discussing aspects of the
                healthcare system but not impacts of this specific rule. For example,
                citations to data about the percent of transgender persons who forgo
                care due to fears or experiences of discrimination, and a calculation
                of the costs to the healthcare system resulting from such occurrences,
                are not sufficient to estimate the effects of this final rule itself,
                due to court orders preliminarily enjoining and then vacating
                provisions in the 2016 Rule, State and local laws that already provide
                gender identity protections, and other factors that prevent the
                Department from showing that this final rule is causing those effects.
                For example, one poll cited by commenters was conducted in 2017, when
                the 2016 Rule was already in place, but when its gender identity
                provisions were preliminarily enjoined. So it is not clear from that
                poll that the 2016 Rule yielded the benefits the commenters say it did,
                and it is even less clear how this final rule will remove those
                benefits. Generally, the Department's review of comments is that
                concerns about increased costs to LGBT persons from this final rule do
                not offer sufficient quantitative evidence for the Department to
                provide an estimate along these dimensions.
                 Finally, as discussed above, because the 2016 Rule contained no
                prohibition on sexual orientation discrimination in the 2016 Rule, the
                Department does not deem there to be an economic impact resulting from
                this final rule with respect to sexual orientation discrimination.
                [[Page 37239]]
                 Consequently, commenters' warnings of effects of this rule's
                changes on these issues do not give rise to impacts that are properly
                attributable to this rule and that the Department believes can be
                estimated for the purposes of this analysis.
                 Comment: One commenter contended that the Department should include
                analysis of the consequences of removing sex stereotyping language from
                the rule. The commenter suggested that costs of this rescission could
                include increased confusion for patients and covered entities,
                increased discrimination based on sex stereotyping with attendant
                economic and non-economic costs to patients and the public health
                system, increased need for legal advice, and increased litigation.
                 Response: To the extent that sex stereotyping language from the
                2016 Rule was interpreted to encompass gender identity, court orders
                have preliminarily enjoined and now vacated those provisions.
                Therefore, this final rule does not directly induce changes in this
                regard. To the extent that sex stereotyping is a recognized category of
                sex discrimination under longstanding Supreme Court precedent, this
                final rule commits the Department to continuing to vigorously enforce
                Title IX through Section 1557, and therefore the Department estimates
                that this final rule will not have any material effect on the scope of
                sex stereotyping claims as authorized by Title IX and Section 1557.
                 Comment: A commenter objected that the proposed rule did not
                estimate the economic impact of withdrawal of Federal guidance and
                technical support concerning the 2016 Rule.
                 Response: All guidance and technical support concerning the 2016
                Rule was withdrawn by operation of the preamble to the proposed rule,
                which itself is a guidance document--not directly by this final rule.
                The outdated guidance documents are in the process of being removed
                from the Department's websites. The Department is not aware of any data
                that would allow it to estimate the effects of changes to its sub-
                regulatory guidance. To the extent that certain guidance and technical
                support concerned provisions of the 2016 Rule that were enjoined and
                vacated, this final rule is not the direct cause of the Department's
                non-enforcement of those provisions.
                 Comment: Some commenters contended that the proposed rule would
                lead to economic burdens concerning termination of pregnancy for women
                and other patients who are denied access to care. One commenter stated
                that there is well-documented research that shows the significant
                healthcare costs women experience when they face healthcare denials.
                Another commenter stated that women will suffer negative health effects
                or death if they are denied services relating to complications from an
                abortion or a miscarriage. Another commenter stated that there are
                costs to patients facing discrimination as a result of having a
                previous termination of pregnancy.
                 Several commenters contended that the proposed rule would place
                undue costs and burdens on survivors of sexual and domestic violence.
                The commenters stated that healthcare programs provide critical and
                costly care for survivors of domestic violence, sexual assault, and
                human trafficking. The commenters stated that recent data from the CDC
                shows that the lifetime per-victim cost of intimate partner violence
                was $103,767 for women victims, with 59% going to medical costs, and
                that more than 550,000 injuries due to intimate partner violence
                require medical attention each year.
                 Response: The Department appreciates comments in this regard. This
                final rule fully commits the Department to enforcement of Section 1557
                and Title IX to protect women from discrimination on the basis of sex,
                including and especially vulnerable populations such as survivors of
                domestic violence, sexual assault, and human trafficking. As noted
                above, court orders have already enjoined and now vacated the
                termination of pregnancy provisions from the 2016 Rule. Therefore, this
                final rule does not have a direct material economic impact with regard
                to discrimination on the basis of termination of pregnancy. This final
                rule further ensures the Department will enforce Section 1557 and Title
                IX consistent with the statutory provisions of Title IX. The Department
                lacks data or methods enabling it to provide quantitative estimates of
                any alleged economic impacts related to termination of pregnancy
                provisions.
                 Comment: A commenter contended that the Department should conduct a
                cost-benefit analysis specifically on the impact of adopting Title IX's
                religious exemptions, or compliance with RFRA.
                 Response: The Department disagrees. The Title IX statute already
                includes certain exemptions concerning religious groups, and RFRA
                protects certain exercises of religion from substantial burdens. This
                final rule affirms that the Department will only enforce Section 1557
                consistent with the statutory provisions of Title IX and RFRA, and
                amends the Title IX regulations to explicitly include the provisions of
                the Title IX statute concerning religious groups and abortion
                neutrality. As the Department is already bound by statute to implement
                Title IX and Section 1557 consistent with those statutes and with RFRA,
                the Department does not attribute its compliance with those statutes to
                be attributable to this final rule. Economic impacts due to compliance
                with Title IX and RFRA would be attributable, not to this final rule,
                but to those statutes themselves, and are not relevant for this
                regulatory impact analysis.
                 Comment: One commenter stated that the Department should estimate
                the economic impacts of its conforming amendments.
                 Response: Section 1557 encompasses all the CMS programs addressed
                by the conforming amendments, so the Department's estimates of impacts
                of changes to the Section 1557 rule already encompass the impact on
                entities covered by those rules.
                (5) Impact on State, Local, and Tribal Entities Under Executive Orders
                12866, 13132, and 13175
                a. State and Local Governments
                 Executive Order 13132 establishes certain requirements that an
                agency must meet when it issues a rule that imposes substantial direct
                requirement costs on State and local governments, preempts State law,
                or otherwise has Federalism implications. Executive Order 13132, 64 FR
                43255 (Aug. 4, 1999). The Department does not believe that this final
                rule would (1) impose substantial direct requirements costs on State or
                local governments; (2) preempt State law; or (3) otherwise have
                Federalism implications. Section 1557 itself provides that it shall not
                be construed ``to supersede State laws that provide additional
                protections against discrimination on any basis described in subsection
                (a) [of Section 1557].'' 42 U.S.C. 18116(b).
                 The final rule maintains the full force of Federal civil rights
                laws' protections against discrimination, but does not attempt to
                impose a ceiling on how those protections may be observed by States.
                State and local jurisdictions would continue to have the flexibility to
                impose additional civil rights protections.
                 The Department believes that there would be reduced costs to State
                and local entities, by repealing wasteful Federal mandates and giving
                States more flexibility to address the needs of LEP individuals or
                other regional-specific issues.
                 The Department believes that the change to its Title IX regulations
                will
                [[Page 37240]]
                not have a substantial direct effect on the States, on the relationship
                between the national government and the States, on the distribution of
                power and responsibilities among the various levels of government, or
                on tribal self-government or sovereignty. This final rule does not
                subject Title IX funding recipients to new obligations, but rather
                implements Title IX according to its statutory text, and relieves
                potential burdens on the States or tribes that could have resulted from
                any prior interpretation of Title IX by HHS that was inconsistent with
                the statute. This final rule allows States and tribes to adopt or
                continue to provide nondiscrimination protections on the basis of
                sexual orientation, gender identity, or termination of pregnancy, in
                State, local, and tribal law. Therefore, the Department has determined
                that this final rule does not have sufficient Federalism implications
                to warrant the preparation of a Federalism summary impact statement
                under Executive Order 13132, and that the rule would not implicate the
                requirements of Executive Orders 12866 and 13175 with respect to
                tribes.
                 Comment: One commenter stated it was inconsistent for the
                Department to say the 2016 Rule imposed burdens on States but that the
                proposed rule would not impose new burdens.
                 Response: The 2016 Rule imposed or may have imposed burdens
                concerning notices and taglines, as well as gender identity and
                termination of pregnancy provisions beyond the text of Title IX. This
                final rule can relieve such burdens without imposing new burdens. To
                the extent that the gender identity and termination of pregnancy
                provisions were vacated in October 2019, the Department agrees this
                final rule does not relieve such burdens, but to the same extent, this
                final rule does not impose any corresponding burdens.
                 Comment: A commenter stated that HHS points to no evidence of
                substantial burdens on States and localities as regards the provision
                or coverage of medically necessary care related to gender transition.
                 Response: The Department's conclusion that this final rule does not
                impose new burdens on States and localities is independent of the
                Department's suggestion that the 2016 Rule, to the extent it prohibited
                discrimination on grounds exceeding Title IX and State and local law,
                also imposed burdens on such States and localities.
                 Comment: One commenter stated that the proposed rule could impose
                additional costs on States that adopted policies related to private
                insurance and Medicaid based on the 2016 Rule that see an increase in
                healthcare discrimination complaints in their State-level human rights
                commissions, as HHS OCR will no longer receive such complaints, and
                such States may reinstate or maintain exclusions and face costly
                litigation.
                 Response: The court orders preliminarily enjoining and eventually
                vacating the 2016 Rule's gender identity and termination of pregnancy
                provisions have been in effect since December 2016. States have,
                therefore, not been bound by those provisions, and this final rule's
                changes in that regard will not cause States to need to change their
                policies in that regard. States will also not likely see an increase in
                complaints at the State level as a result of this rule, because HHS OCR
                has not been able to enforce those provisions for almost the entire
                lifespan of the 2016 Rule. Finally, this rule does not require States
                to reinstate exclusions from coverage, so litigation that States might
                face as a result of doing so are not directly attributable to this
                final rule.
                b. Tribal Governments
                 Executive Order 12866 directs that significant regulatory actions
                avoid undue interference with State, local, or tribal governments, in
                the exercise of their governmental functions. Executive Order 12866 at
                Sec. 6(a)(3)(B).\382\ Executive Order 13175 further directs that
                Agencies respect Indian tribal self-government and sovereignty, honor
                tribal treaty and other rights, and strive to meet the responsibilities
                that arise from the unique legal relationship between the Federal
                Government and Indian tribal governments. Executive Order 13175 at
                Sec. 2(a). The Department does not believe that the final rule would
                implicate the requirements of Executive Orders 12866 and 13175 with
                respect to tribal sovereignty.
                ---------------------------------------------------------------------------
                 \382\ As stated in the preceding section, the final rule does
                not have Federalism implications.
                ---------------------------------------------------------------------------
                (6) Avoidance of Inconsistent, Incompatible, or Duplicative Regulations
                 Executive Order 12866 requires the Department to avoid issuing
                regulations that are inconsistent, incompatible, or duplicative with
                other regulations that it has issued or that have been issued by other
                Federal agencies. Executive Order 12866 at Sec. 1(b)(10). Section 1557
                itself requires avoidance of duplication by providing that the
                enforcement mechanisms under specifically identified civil rights laws
                ``shall apply for purposes of violations'' of Section 1557. 42 U.S.C.
                18116(a).\383\ The preamble to the 2016 Rule repeatedly stated that,
                with the exception of issues concerning notices, sex discrimination,
                and language access plans, it was merely applying civil rights
                protections that were already applicable and familiar to covered
                entities. See 81 FR at 31446. (``It is important to recognize that this
                final rule, except in the area of sex discrimination, applies pre-
                existing requirements in Federal civil rights laws to various entities,
                the great majority of which have been covered by these requirements for
                years.''); 81 FR at 31464 (``For the most part, because this regulation
                is consistent with existing standards applicable to the covered
                entities, the new burdens created by its issuance are minimal.'').
                ---------------------------------------------------------------------------
                 \383\ For the applicable enforcement mechanisms, See 45 CFR
                parts 80 and 81 (Title VI), 85 (Section 504), 86 (Title IX), 90 and
                91 (Age Act).
                ---------------------------------------------------------------------------
                 With regard to the current 2016 Rule's notice and taglines
                requirement, covered entities are already subject to dozens of
                regulations concerning multi-language taglines or notices concerning an
                individual's right to have documents translated. For example, CMS
                imposes taglines requirements on health insurance marketplaces, QHP
                issuers, group health plans and health insurance issuers, navigators,
                non-navigator assistance personnel, Medicaid, Medicaid managed care,
                Children's Health Insurance Program, Medicare Advantage, and Medicare
                Part D.\384\
                [[Page 37241]]
                Furthermore, a Department of Treasury regulation imposed taglines
                requirements for hospital organizations to qualify for tax-exempt
                status.\385\ Additionally, in 2003, the Department issued guidance
                under Title VI, setting forth a flexible four-factor framework to
                assess the necessity and reasonableness for providing written
                translation for LEP individuals.\386\ Finally, the ACA itself provides
                that each summary of benefits and coverage provided by issuers--perhaps
                the single most important health insurance-related document a person
                receives--must be ``presented in a culturally and linguistically
                appropriate manner.'' 42 U.S.C. 300gg-15(b)(2).
                ---------------------------------------------------------------------------
                 \384\ 45 CFR 147.136(e)(2)(iii) and (e)(3) and Sec.
                147.200(a)(5) (requiring group health plans and QHP issuers to post
                taglines in languages in which 10% of individuals with LEP county-
                wide are exclusively literate on internal claims and appeals
                notices, and requiring QHP issuers to post on its Summary of
                Benefits and Coverage), Sec. 155.215(c)(4) (requiring Navigators
                and non-Navigator personnel in States with Marketplaces operated by
                HHS to ``[p]rovide oral and written notice to consumers with LEP, in
                their preferred language, informing them of their right to receive
                language assistance services and how to obtain them''); 42 CFR
                435.905(b)(3) (Medicaid regulations requiring individuals to be
                ``informed of the availability of language services . . . and how to
                access . . . [them] through providing taglines in non-English
                languages indicating the availability of language services''); Sec.
                438.10(c)(5)(i) through (ii) (Medicaid managed care regulations
                requiring taglines until July 1, 2017); Sec. 438.10(d)(2) through
                (3), (d)(5)(i), (d)(5)(iii) and (d)(5)(j) (Medicaid managed care
                regulations requiring taglines on ``all written materials for
                potential enrollees'' in the prevalent non-English languages in the
                State and requiring notification that ``oral interpretation is
                available for any language and written translation is available in
                prevalent languages'' during the rating period for contracts with
                managed care entities beginning on or after July 1, 2017), Sec.
                457.340(a) (applying certain Medicaid requirements to the Children's
                Health Insurance Program, including Sec. 435.905(b)(3), which
                requires individuals to be ``informed of the availability of
                language services . . . and how to access . . . [them] through
                providing taglines in non-English languages indicating the
                availability of language services''), 457.1207 (applying certain
                Medicaid managed care requirements to Children's Health Insurance
                Program managed care, including Sec. 438.10(c)(5)(i)-(ii) until the
                State fiscal year beginning on or after July, 1, 2018), Sec.
                438.10(d)(2)-(3), (d)(5)(i), (iii), (j) (applying certain Medicaid
                managed care requirements to Children's Health Insurance Program
                managed care, in the State fiscal year beginning on or after July,
                1, 2018); CMS, 2017 Medicare Marketing Guidelines, Sec. 30.5.1,
                Sec. 100.2.2, Sec. 8, Sec. 80-8 (Jun. 10, 2016), https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/Downloads/2017MedicareMarketingGuidelines2.pdf (providing a CMS Multi-Language
                Insert'' for certain Medicare Advantage Plan's and Medicare Part D
                Plan Sponsors' marketing materials meeting the percentage
                translation threshold in Sec. 422.2264(e) and Sec. 423.2264(e) of
                Title 42 of the CFR). As discussed in the RIA section, we presume 45
                CFR 155.205(c)(2)(iii)(A) (requiring Marketplaces and QHP issuers to
                post taglines on their websites and documents ``critical for
                obtaining health insurance coverage or access to health care
                services through a QHP'') and other provisions that depend or refer
                to 45 CFR part 92 for their tagline requirements will no longer
                apply under this final rule.
                 \385\ See 79 FR 78954 (Dec. 31, 2014) (finalizing rule requiring
                the plain language summary of the financial assistance policy for
                hospital organizations to qualify as tax exempt, to indicate, if
                applicable, whether the summary, the financial assistance policy,
                and the application for such assistance are available in other
                languages).
                 \386\ Guidance to Federal Financial Assistance Recipients
                Regarding Title VI Prohibition Against National Origin
                Discrimination Affecting Limited English Proficient Persons, 68 FR
                47315 (Aug. 8, 2003) (HHS LEP Guidance).
                ---------------------------------------------------------------------------
                 Substantially replacing many provisions of the 2016 Rule, including
                removing the notice and taglines requirements, would eliminate
                significant redundancies identified above, while maintaining vigorous
                enforcement of existing Federal civil rights statutes.
                B. Executive Order 13771 on Reducing and Controlling Regulatory Costs
                 This final rule is deemed an E.O. 13771 deregulatory action. The
                Department estimates that this final rule would generate $0.24 billion
                in net annualized savings at a 7% discount rate (discounted relative to
                year 2016, over a perpetual time horizon, in 2016 dollars).
                 Furthermore, Executive Order 13765 states that ``the Secretary of
                Health and Human Services (Secretary) and the heads of all other
                executive departments and agencies (agencies) with authorities and
                responsibilities under the [ACA] shall exercise all authority and
                discretion available to waive, defer, grant exemptions from, or delay
                the implementation of any provision or requirement of the [ACA] that
                would impose a fiscal burden on any State or a cost, fee, tax, penalty,
                or regulatory burden on individuals, families, healthcare providers,
                health insurers, patients, recipients of healthcare services, [or]
                purchasers of health insurance.'' Executive Order 13765, 82 FR 8351,
                8351 (Jan. 24, 2017). In implementing Section 1557 of the ACA, the 2016
                Rule imposed significant regulatory burdens on covered entities,
                including States, healthcare providers, and health insurers, without
                sufficient corresponding benefits for patients or beneficiaries. By
                proposing to substantially replace the 2016 Rule with a regulation that
                requires compliance with pre-existing civil rights laws, the Department
                is acting in accordance with Executive Order 13765 in exercising its
                authority and discretion to address the fiscal burdens on States, and
                the regulatory burdens imposed on individuals, families, healthcare
                providers, health insurers, patients, and recipients of healthcare
                service. The final rule will particularly reduce the economic burden
                imposed on healthcare providers and insurers required to provide
                taglines under the 2016 Rule. Decreasing the burden on these providers
                and insurers will allow them to pass along some of the cost savings to
                individuals, families, patients, and beneficiaries of insurance to whom
                they provide services or coverage. Additionally, eliminating the
                taglines requirement will alleviate burdens on patients and insurance
                beneficiaries that neither need nor want to receive repeated taglines
                mailings.
                C. Congressional Review Act
                 The Congressional Review Act (CRA) defines a ``major rule'' as
                ``any rule that the Administrator of the Office of Information and
                Regulatory Affairs (OIRA) of the Office of Management and Budget finds
                has resulted in or is likely to result in--(A) an annual effect on the
                economy of $100,000,000 or more; (B) a major increase in costs or
                prices for consumers, individual industries, Federal, State, or local
                government agencies, or geographic regions; or (C) significant adverse
                effects on competition, employment, investment, productivity,
                innovation, or on the ability of United States-based enterprises to
                compete with foreign-based enterprises in domestic and export
                markets.'' 5 U.S.C. 804(2). Based on the analysis of this final rule
                under Executive Order 12866, this rule is expected to be a major rule
                for purposes of the CRA because it generates cost savings of over $100
                million. The Department will comply with the CRA's requirements to
                inform Congress.
                D. Unfunded Mandates Reform Act
                 This final rule is not subject to the Unfunded Mandates Reform Act
                because it falls under an exception for regulations that establish or
                enforce any statutory rights that prohibit discrimination on the basis
                of race, color, religion, sex, national origin, age, handicap, or
                disability. 2 U.S.C. 1503(2).
                E. Regulatory Flexibility Act and Executive Order 13272 on Proper
                Consideration of Small Entities in Agency Rulemaking
                 The Regulatory Flexibility Act (RFA) requires agencies to analyze
                regulatory options that would minimize any significant impact of a rule
                on small entities. Public Law 96-354, 94 Stat. 1164 (Sept. 19, 1980)
                (codified at 5 U.S.C. 601 through 612). The RFA requires an agency to
                describe the impact of a rulemaking on small entities by providing an
                initial regulatory flexibility analysis, unless the agency expects that
                the rule will not have a significant economic impact on a substantial
                number of small entities, provides a factual basis for this
                determination, and proposes to certify the statement. 5 U.S.C. 603(a),
                605(b). If an agency must provide an initial regulatory flexibility
                analysis, this analysis must address the consideration of regulatory
                options that would minimize the economic impact of the rule on small
                entities. 5 U.S.C. 603(c).
                 For purposes of the RFA, small entities include small businesses,
                nonprofit organizations, and small governmental jurisdictions. HHS
                considers a rule to have a significant impact on a substantial number
                of small entities if it has at least a three percent impact on revenue
                for at least five percent of small entities.
                 Based on its examination, the Department has concluded that this
                final rule does not have a significant economic impact on a substantial
                number of small entities. The preamble to the 2016 Rule discussed the
                character of small entities impacted by the 2016 Rule in detail. 81 FR
                at 31463-64. Although this final rule will affect numerous small
                entities, it does not create new or expanded requirements,
                [[Page 37242]]
                and, for all the reasons stated in the RIA, it will be reducing
                economic burdens on such entities overall. The changes concerning
                gender identity and termination of pregnancy, having already been
                vacated by court order, are not expected to result in any impact. The
                changes to the Department's Title IX rule would not impose any new
                substantive obligations on Federal funding recipients and, in fact,
                would provide regulatory clarity and relief for any small entities
                previously subject to several of the policies and requirements imposed
                by the Department. The changes made in conforming amendments overlap
                those made in the Section 1557 rule and described in the RIA.
                 To the extent that this final rule imposes economic costs, these
                are generally limited to entities' voluntary choices to revise their
                policies and procedures and conduct training, and the Department
                believes these costs are well below those required to have a
                significant impact on a substantial number of small entities. In
                addition, the majority of the costs associated with this final rule are
                proportional to the size of entities, meaning that even the smallest of
                the affected entities are unlikely to face a substantial impact.
                 For these reasons, the Secretary certifies that the final rule will
                not have a significant impact on a substantial number of small
                entities.
                 Executive Order 13272 on Proper Consideration of Small Entities in
                Agency Rulemaking reinforces the requirements of the RFA and requires
                the Department to notify the Chief Counsel for Advocacy of the Small
                Business Administration if the final rule may have a significant
                economic impact on a substantial number of small entities under the
                RFA. Executive Order 13272, 67 FR 53461 (Aug. 16, 2002). Because the
                economic impact of the proposed rule is not significant under the RFA,
                the Department is not subject to Executive Order 13272's notification
                requirement.
                F. Executive Order 12250 on Leadership and Coordination of
                Nondiscrimination Laws
                 Pursuant to Executive Order 12250, the Attorney General has the
                responsibility to ``coordinate the implementation and enforcement by
                Executive agencies of . . . Title IX of the Education Amendments of
                1972 (20 U.S.C. 1681 et seq.)'' Executive Order 12250 at Sec. 1-2(b),
                45 FR 72995 (Nov. 2, 1980). The proposed rule was reviewed and approved
                by the Attorney General, and this final rule was also reviewed and
                approved by the Attorney General in finalizing the proposed rule
                without change.
                G. Paperwork Reduction Act
                 The Department has determined that this final rule does not impose
                additional reporting or recordkeeping requirements under the Paperwork
                Reduction Act of 1995, 44 U.S.C. 3501 et seq. Under the rule, OCR will
                update and revise its burden analysis by removing the burden associated
                with the posting of a nondiscrimination notice and taglines,
                development and implementation of a language access plan, and
                designation of a compliance coordinator and adoption of grievance
                procedures for covered entities with 15 or more employees. OCR has
                obtained Paperwork Reduction Act approval for this reporting
                requirement via an update to HHS Form 690 (Consolidated Civil Rights
                Assurance Form) \387\ separate from this rulemaking.
                ---------------------------------------------------------------------------
                 \387\ See HHS OCR, Assurance of Compliance Portal, https://ocrportal.hhs.gov/ocr/aoc/instruction.jsf.
                ---------------------------------------------------------------------------
                (D) Delegation of Authority
                 Notice is hereby given that I have delegated to the Director,
                Office for Civil Rights (OCR), with authority to re-delegate,
                enforcement and administration of Section 1557 of the Patient
                Protection and Affordable Care Act [42 U.S.C. 18116]. This delegation
                includes the authority to develop and direct implementation of the
                requirements of Section 1557 of the Patient Protection and Affordable
                Care Act [42 U.S.C. 18116] as applied to the Department and recipients
                of the Department's funds. This delegation supersedes the delegation of
                authority under Section 1557 to the Health Resources and Services
                Administration (HRSA) on April 21, 2016 in 81 FR 25680 (April 29,
                2016).
                List of Subjects
                42 CFR Part 438
                 Civil rights, Discrimination, Grant programs-health, Individuals
                with disabilities, Medicaid, National origin, Nondiscrimination,
                Reporting and recordkeeping requirements, Sex discrimination.
                42 CFR Part 440
                 Civil rights, Discrimination, Grant programs-health, Individuals
                with disabilities, Medicaid, National origin, Nondiscrimination, Sex
                discrimination.
                42 CFR Part 460
                 Age discrimination, Aged, Civil rights, Discrimination, Health
                Incorporation by reference, Individuals with disabilities, Medicare,
                Medicaid, National origin, Nondiscrimination, Religious discrimination,
                Reporting and recordkeeping requirements, Sex discrimination.
                45 CFR Part 86
                 Civil rights, Colleges and universities, Employment, Administrative
                practice and procedure, Buildings and facilities, Education of
                individuals with disabilities, Education, Educational facilities,
                Educational research, Educational study programs, Equal educational
                opportunity, Equal employment opportunity, Graduate fellowship program,
                Grant programs--education, Individuals with disabilities,
                Investigations, Reporting and recordkeeping requirements, Sex
                discrimination, State agreement program, Student aid, Women.
                45 CFR Part 92
                 Administrative practice and procedure, Age discrimination, Civil
                rights, Discrimination, Elderly, Healthcare, Health facilities, Health
                insurance, Health programs or activities, Individuals with
                disabilities, National origin, Nondiscrimination, Reporting and
                recordkeeping requirements, Sex discrimination.
                45 CFR Part 147
                 Age discrimination, Civil rights, Discrimination, Healthcare,
                Health insurance, Individuals with disabilities, National origin,
                Nondiscrimination, Reporting and recordkeeping requirements, Sex
                discrimination, State regulation of health insurance.
                45 CFR Part 155
                 Actuarial value, Administration and calculation of advance payments
                of the premium tax credit, Administrative practice and procedure,
                Advance payments of premium tax credit, Age discrimination, Civil
                rights, Cost-sharing reductions, Discrimination, Healthcare access,
                Health insurance, Individuals with disabilities, National origin,
                Nondiscrimination, Plan variations, Reporting and recordkeeping
                requirements, Sex discrimination, State and local governments.
                45 CFR Part 156
                 Administrative appeals, Administrative practice and procedure,
                Administration and calculation of advance payments of premium tax
                credit, Advertising, Advisory Committees, Age discrimination, Brokers,
                Civil rights, Conflict of interest, Consumer protection, Cost-sharing
                reductions, Discrimination, Grant programs-health, Grants
                administration,
                [[Page 37243]]
                Healthcare, Health insurance, Health maintenance organization (HMO),
                Health records, Hospitals, American Indian/Alaska Natives, Individuals
                with disabilities, Loan programs-health, Organization and functions
                (Government agencies), Medicaid, National origin, Nondiscrimination,
                Payment and collections reports, Public assistance programs, Reporting
                and recordkeeping requirements, Sex discrimination, State and local
                governments, Sunshine Act, Technical assistance, Women, Youth.
                 For the reasons set forth in the preamble, the Department of Health
                and Human Services amends 42 CFR parts 438, 440, and 460 and 45 CFR
                parts 86, 92, 147, 155, and 156 as follows:
                Title 42--Public Health
                PART 438--MANAGED CARE
                0
                1. The authority citation for part 438 continues to read as follows:
                 Authority: 42 U.S.C. 1302.
                0
                2. Amend Sec. 438.3 by revising paragraph (d)(4) to read as follows:
                Sec. 438.3 Standard contract requirements.
                * * * * *
                 (d) * * *
                 (4) The MCO, PIHP, PAHP, PCCM or PCCM entity will not discriminate
                against individuals eligible to enroll on the basis of race, color,
                national origin, sex, or disability and will not use any policy or
                practice that has the effect of discriminating on the basis of race,
                color, or national origin, sex, or disability.
                * * * * *
                0
                3. Amend Sec. 438.206 by revising paragraph (c)(2) to read as follows:
                Sec. 438.206 Availability of services.
                * * * * *
                 (c) * * *
                 (2) Access and cultural considerations. Each MCO, PIHP, and PAHP
                participates in the State's efforts to promote the delivery of services
                in a culturally competent manner to all enrollees, including those with
                limited English proficiency and diverse cultural and ethnic
                backgrounds, disabilities, and regardless of sex.
                * * * * *
                PART 440--SERVICES: GENERAL PROVISIONS
                0
                4. The authority citation for part 440 continues to read as follows:
                 Authority: 42 U.S.C. 1302.
                0
                5. Revise Sec. 440.262 to read as follows:
                Sec. 440.262 Access and cultural conditions.
                 The State must have methods to promote access and delivery of
                services in a culturally competent manner to all beneficiaries,
                including those with limited English proficiency, diverse cultural and
                ethnic backgrounds, disabilities, and regardless of sex. These methods
                must ensure that beneficiaries have access to covered services that are
                delivered in a manner that meets their unique needs.
                PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
                0
                6. The authority citation for part 460 continues to read as follows:
                 Authority: 42 U.S.C. 1302, 1395l, 1395eee(f), and 1396u-4(f)).
                0
                7. Amend Sec. 460.98 by revising paragraph (b)(3) to read as follows:
                Sec. 460.98 Service delivery.
                * * * * *
                 (b) * * *
                 (3) The PACE organization may not discriminate against any
                participant in the delivery of required PACE services based on race,
                ethnicity, national origin, religion, sex, age, mental or physical
                disability, or source of payment.
                * * * * *
                0
                8. Amend Sec. 460.112 by revising paragraph (a) to read as follows:
                Sec. 460.112 Specific rights to which a participant is entitled.
                 (a) Respect and nondiscrimination. Each participant has the right
                to considerate, respectful care from all PACE employees and contractors
                at all times and under all circumstances. Each participant has the
                right not to be discriminated against in the delivery of required PACE
                services based on race, ethnicity, national origin, religion, sex, age,
                mental or physical disability, or source of payment. Specifically, each
                participant has the right to the following:
                 (1) To receive comprehensive health care in a safe and clean
                environment and in an accessible manner.
                 (2) To be treated with dignity and respect, be afforded privacy and
                confidentiality in all aspects of care, and be provided humane care.
                 (3) Not to be required to perform services for the PACE
                organization.
                 (4) To have reasonable access to a telephone.
                 (5) To be free from harm, including physical or mental abuse,
                neglect, corporal punishment, involuntary seclusion, excessive
                medication, and any physical or chemical restraint imposed for purposes
                of discipline or convenience and not required to treat the
                participant's medical symptoms.
                 (6) To be encouraged and assisted to exercise rights as a
                participant, including the Medicare and Medicaid appeals processes as
                well as civil and other legal rights.
                 (7) To be encouraged and assisted to recommend changes in policies
                and services to PACE staff.
                * * * * *
                Title 45--Public Welfare
                PART 86--NONDISCRIMINATION ON THE BASIS OF SEX IN EDUCATION
                PROGRAMS OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
                0
                9. The authority citation for part 86 is revised to read as follows:
                 Authority: 20 U.S.C. 1681 through 1688; Pub. L. 100-259, 102
                Stat. 28 (Mar. 22, 1988).
                0
                10. Amend Sec. 86.2:
                0
                a. In paragraph (a), by adding ``, 1687, 1688'' after ``1686''; and
                0
                b. In paragraph (n), by removing the words ``United States Commissioner
                of Education'' and adding in their place the words ``Secretary of
                Education''.
                0
                11. Add Sec. 86.18 to read as follows:
                Sec. 86.18 Amendments to conform to statutory exemptions.
                 (a) Nothing in this part shall be construed to force or require any
                individual or hospital or any other institution, program, or activity
                receiving Federal funds to perform or pay for an abortion.
                 (b) Nothing in this part shall be construed to require or prohibit
                any person, or public or private entity, to provide or pay for any
                benefit or service, including the use of facilities, related to an
                abortion. Nothing in the preceding sentence shall be construed to
                permit a penalty to be imposed on any person or individual because such
                person or individual is seeking or has received any benefit or service
                related to a legal abortion.
                 (c) This part shall be construed consistently with, as applicable,
                the First Amendment to the Constitution, Title IX's religious
                exemptions (20 U.S.C. 1681(a)(3) and 1687(4)), the Religious Freedom
                Restoration Act (42 U.S.C. 2000b et seq.), and provisions related to
                abortion in the Church Amendments (42 U.S.C. 300a-7), the Coats-Snowe
                Amendment (42 U.S.C. 238n), section 1303 of the Patient Protection and
                Affordable Care Act (42 U.S.C. 18023), and appropriation rider
                provisions relating to abortion, to the extent they remain in effect or
                applicable, such as the Hyde
                [[Page 37244]]
                Amendment (e.g., Consolidated Appropriations Act, 2019, Pub. L. 115-
                245, Div. B, secs. 506-07), the Helms Amendment (e.g., Continuing
                Appropriations Act, 2019, Pub. L. 116-6, Div. F, Title III), and the
                Weldon Amendment (e.g., Consolidated Appropriations Act, 2019, Pub. L.
                115-245, Div. B, sec. 507(d)).
                0
                12. Amend Sec. 86.31 by revising paragraph (b) to read as follows:
                Sec. 86.31 Education programs or activities.
                * * * * *
                 (b) Specific prohibitions. Except as provided in this subsection,
                in providing any aid, benefit, or service to a student, a recipient
                shall not, on the basis of sex:
                 (1) Treat one person differently from another in determining
                whether such person satisfies any requirement or condition for the
                provision of such aid, benefit, or service;
                 (2) Provide different aid, benefits, or services or provide aid,
                benefits, or services in a different manner;
                 (3) Deny any person any such aid, benefit, or service;
                 (4) Subject any person to separate or different rules of behavior,
                sanctions, or other treatment;
                 (5) Apply any rule concerning the domicile or residence of a
                student or applicant, including eligibility for in-State fees and
                tuition;
                 (6) Aid or perpetuate discrimination against any person by
                providing significant assistance to any agency, organization, or person
                which discriminates on the basis of sex in providing any aid, benefit
                or service to students or employees;
                 (7) Otherwise limit any person in the enjoyment of any right,
                privilege, advantage, or opportunity.
                * * * * *
                0
                13. Revise Sec. 86.71 to read as follows:
                Sec. 86.71 Enforcement procedures.
                 For the purposes of implementing this Part, the procedural
                provisions applicable to Title VI of the Civil Rights Act of 1964 (42
                U.S.C. 2000d) are hereby adopted and incorporated herein by reference.
                These procedures may be found at 45 CFR 80.6 through 80.11 and 45 CFR
                part 81.
                0
                14. Revise part 92 to read as follows:
                PART 92--NONDISCRIMINATION ON THE BASIS OF RACE, COLOR, NATIONAL
                ORIGIN, SEX, AGE, OR DISABILITY IN HEALTH PROGRAMS OR ACTIVITIES
                RECEIVING FEDERAL FINANCIAL ASSISTANCE AND PROGRAMS OR ACTIVITIES
                ADMINISTERED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES UNDER
                TITLE I OF THE PATIENT PROTECTION AND AFFORDABLE CARE ACT OR BY
                ENTITIES ESTABLISHED UNDER SUCH TITLE
                Subpart A--General Provisions
                Sec.
                92.1 Purpose.
                92.2 Nondiscrimination requirements.
                92.3 Scope of application.
                92.4 Assurances.
                92.5 Enforcement mechanisms.
                92.6 Relationship to other laws.
                Subpart B--Specific Applications to Health Programs or Activities
                92.101 Meaningful access for individuals with limited English
                proficiency.
                92.102 Effective communication for individuals with disabilities.
                92.103 Accessibility standards for buildings and facilities.
                92.104 Accessibility of information and communication technology.
                92.105 Requirement to make reasonable modifications.
                 Authority: 42 U.S.C. 18116; 5 U.S.C. 301, Pub. L. 100-259, 102
                Stat. 28 (Mar. 22 1988); 42 U.S.C. 2000d et seq. (Title VI of the
                Civil Rights Act of 1964, as amended); 29 U.S.C. 794 (Section 504 of
                the Rehabilitation Act of 1973, as amended); 20 U.S.C. 1681 et seq.
                (Title IX of the Education Amendments of 1972, as amended); 42
                U.S.C. 6101 et seq.; (Age Discrimination Act of 1975, as amended);
                Lau v. Nichols, 414 U.S. 563 (1974).
                Subpart A--General Provisions
                Sec. 92.1 Purpose.
                 The purpose of this part is to provide for the enforcement of
                section 1557 of the Patient Protection and Affordable Care Act, 42
                U.S.C. 18116, prohibiting discrimination under any health program or
                activity receiving Federal financial assistance, or under any program
                or activity administered by an Executive agency, or by any entity
                established, under Title I of such law, on the grounds of race, color,
                national origin, sex, age, or disability, except as provided in Title I
                of such law (or any amendment thereto). Section 1557 requires the
                application of the enforcement mechanisms under Title VI of the Civil
                Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title IX of the Education
                Amendments of 1972 (20 U.S.C. 1681 et seq.), the Age Discrimination Act
                of 1975 (42 U.S.C. 6101 et seq.), and Section 504 of the Rehabilitation
                Act of 1973 (29 U.S.C. 794) for purposes of violations of Section 1557
                and this part.
                Sec. 92.2 Nondiscrimination requirements.
                 (a) Except as provided in Title I of the Patient Protection and
                Affordable Care Act (or any amendment thereto), an individual shall
                not, on any of the grounds set forth in paragraph (b) of this section,
                be excluded from participation in, be denied the benefits of, or be
                subjected to discrimination under any health program or activity, any
                part of which is receiving Federal financial assistance (including
                credits, subsidies, or contracts of insurance) provided by the U.S.
                Department of Health and Human Services; or under any program or
                activity administered by the Department under such Title; or under any
                program or activity administered by any entity established under such
                Title.
                 (b) The grounds are the grounds prohibited under the following
                statutes:
                 (1) Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et
                seq.) (race, color, national origin);
                 (2) Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et
                seq.) (sex);
                 (3) The Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.)
                (age); or
                 (4) Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794)
                (disability).
                Sec. 92.3 Scope of application.
                 (a) Except as otherwise provided in this part, this part applies to
                 (1) Any health program or activity, any part of which is receiving
                Federal financial assistance (including credits, subsidies, or
                contracts of insurance) provided by the Department;
                 (2) Any program or activity administered by the Department under
                Title I of the Patient Protection and Affordable Care Act; or
                 (3) Any program or activity administered by any entity established
                under such Title.
                 (b) As used in this part, ``health program or activity''
                encompasses all of the operations of entities principally engaged in
                the business of providing healthcare that receive Federal financial
                assistance as described in paragraph (a)(1) of this section. For any
                entity not principally engaged in the business of providing healthcare,
                the requirements applicable to a ``health program or activity'' under
                this part shall apply to such entity's operations only to the extent
                any such operation receives Federal financial assistance as described
                in paragraph (a)(1) of this section.
                 (c) For purposes of this part, an entity principally or otherwise
                engaged in the
                [[Page 37245]]
                business of providing health insurance shall not, by virtue of such
                provision, be considered to be principally engaged in the business of
                providing healthcare.
                 (d) Any provision of this part held to be invalid or unenforceable
                by its terms, or as applied to any person or circumstance, shall be
                construed so as to continue to give maximum effect to the provision
                permitted by law, unless such holding shall be one of utter invalidity
                or unenforceability, in which event the provision shall be severable
                from this part and shall not affect the remainder thereof or the
                application of the provision to other persons not similarly situated or
                to other, dissimilar circumstances.
                Sec. 92.4 Assurances.
                 (a) Assurances. An entity applying for Federal financial assistance
                to which this part applies shall, as a condition of any application for
                Federal financial assistance, submit an assurance, on a form specified
                by the Director of the Department's Office for Civil Rights, that the
                entity's health programs or activities will be operated in compliance
                with section 1557 and this part. A health insurance issuer seeking
                certification to participate in an Exchange or a State seeking approval
                to operate a State Exchange to which section 1557 or this part applies
                shall, as a condition of certification or approval, submit an
                assurance, on a form specified by the Director of the Department's
                Office for Civil Rights, that the health program or activity will be
                operated in compliance with section 1557 and this part. An applicant or
                entity may incorporate this assurance by reference in subsequent
                applications to the Department for Federal financial assistance or
                requests for certification to participate in an Exchange or approval to
                operate a State Exchange.
                 (b) Duration of obligation. The duration of the assurances required
                by this subpart is the same as the duration of the assurances required
                in the Department's regulations implementing section 504 at 45 CFR
                84.5(b).
                 (c) Covenants. When Federal financial assistance is provided in the
                form of real property or interest, the same conditions apply as those
                contained in the Department's regulations implementing section 504 at
                45 CFR 84.5(c), except that the nondiscrimination obligation applies to
                discrimination on all bases covered under section 1557 and this part.
                Sec. 92.5 Enforcement mechanisms.
                 (a) The enforcement mechanisms provided for, and available under,
                Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.),
                Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.),
                the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), or Section
                504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), including under
                the Department's regulations implementing those statutes, shall apply
                for purposes of violations of Sec. 92.2 of this part.
                 (b) The Director of the Office for Civil Rights has been delegated
                the authority to enforce 42 U.S.C. 18116 and this part, which includes
                the authority to handle complaints, initiate and conduct compliance
                reviews, conduct investigations, supervise and coordinate compliance
                within the Department, make enforcement referrals to the Department of
                Justice, in coordination with the Office of the General Counsel and the
                relevant component or components of the Department, and take other
                appropriate remedial action as the Director deems necessary, in
                coordination with the relevant component or components of the
                Department, and as allowed by law to overcome the effects of violations
                of 42 U.S.C. 18116 or of this part.
                Sec. 92.6 Relationship to other laws.
                 (a) Nothing in this part shall be construed to invalidate or limit
                the rights, remedies, procedures, or legal standards available to
                individuals aggrieved under Title VI of the Civil Rights Act of 1964
                (42 U.S.C. 2000d et seq.), Title VII of the Civil Rights Act of 1964
                (42 U.S.C. 2000e et seq.), Title IX of the Education Amendments of 1972
                (20 U.S.C. 1681 et seq.), the Age Discrimination Act of 1975 (42 U.S.C.
                6101 et seq.), or Section 504 of the Rehabilitation Act of 1973 (29
                U.S.C. 794), or to supersede State laws that provide additional
                protections against discrimination on any basis described in Sec. 92.2
                of this part.
                 (b) Insofar as the application of any requirement under this part
                would violate, depart from, or contradict definitions, exemptions,
                affirmative rights, or protections provided by any of the statutes
                cited in paragraph (a) of this section or provided by the Architectural
                Barriers Act of 1968 (42 U.S.C. 4151 et seq.); the Americans with
                Disabilities Act of 1990, as amended by the Americans with Disabilities
                Act Amendments Act of 2008 (42 U.S.C. 12181 et seq.), Section 508 of
                the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d), the Coats-
                Snowe Amendment (42 U.S.C. 238n), the Church Amendments (42 U.S.C.
                300a-7), the Religious Freedom Restoration Act (42 U.S.C. 2000bb et
                seq.), Section 1553 of the Patient Protection and Affordable Care Act
                (42 U.S.C. 18113), Section 1303 of the Patient Protection and
                Affordable Care Act (42 U.S.C. 18023), the Weldon Amendment
                (Consolidated Appropriations Act, 2019, Pub. L. 115-245, Div. B sec.
                209 and sec. 506(d) (Sept. 28, 2018)), or any related, successor, or
                similar Federal laws or regulations, such application shall not be
                imposed or required.
                Subpart B--Specific Applications to Health Programs or Activities
                Sec. 92.101 Meaningful access for individuals with limited English
                proficiency.
                 (a) Any entity operating or administering a health program or
                activity subject to this part shall take reasonable steps to ensure
                meaningful access to such programs or activities by limited English
                proficient individuals.
                 (b) Specific applications--(1) Enforcement discretion. In
                evaluating whether any entity to which paragraph (a) of this section
                applies has complied with paragraph (a) of this section, the Director
                of the Department's Office for Civil Rights may assess how such entity
                balances the following four factors:
                 (i) The number or proportion of limited English proficient
                individuals eligible to be served or likely to be encountered in the
                eligible service population;
                 (ii) The frequency with which LEP individuals come in contact with
                the entity's health program, activity, or service;
                 (iii) The nature and importance of the entity's health program,
                activity, or service; and
                 (iv) The resources available to the entity and costs.
                 (2) Language assistance services requirements. Where paragraph (a)
                of this section, in light of the entity's individualized assessment of
                the four factors set forth in paragraph (b)(1) of this section,
                requires the provision of language assistance services, such services
                must be provided free of charge, be accurate and timely, and protect
                the privacy and independence of the individual with limited English
                proficiency. Language assistance services may include:
                 (i) Oral language assistance, including interpretation in non-
                English languages provided in-person or remotely by a qualified
                interpreter for an individual with limited English proficiency, and the
                use of qualified bilingual or multilingual staff to communicate
                directly with individuals with limited English proficiency; and
                 (ii) Written translation, performed by a qualified translator, of
                written content in paper or electronic form into languages other than
                English.
                [[Page 37246]]
                 (3) Specific requirements for interpreter and translation services.
                (i) Where paragraph (a) of this section, in light of the entity's
                individualized assessment of the four factors set forth in paragraph
                (b)(1) of this section, requires the provision of interpreter services,
                they must be provided by an interpreter who:
                 (A) Adheres to generally accepted interpreter ethics principles,
                including client confidentiality;
                 (B) Has demonstrated proficiency in speaking and understanding at
                least spoken English and the spoken language in need of interpretation;
                and
                 (C) Is able to interpret effectively, accurately, and impartially,
                both receptively and expressly, to and from such language(s) and
                English, using any necessary specialized vocabulary, terminology and
                phraseology.
                 (ii) Where paragraph (a) of this section, in light of the entity's
                individualized assessment of the four factors set forth in paragraph
                (b)(1) of this section, requires the provision of translation services
                for written content (in paper or electronic form), they must be
                provided by a translator who:
                 (A) Adheres to generally accepted translator ethics principles,
                including client confidentiality;
                 (B) Has demonstrated proficiency in writing and understanding at
                least written English and the written language in need of translation;
                and
                 (C) Is able to translate effectively, accurately, and impartially
                to and from such language(s) and English, using any necessary
                specialized vocabulary, terminology and phraseology.
                 (iii) If remote audio interpreting services are required to comply
                with paragraph (a) of this section, in light of the entity's
                individualized assessment of the four factors set forth in paragraph
                (b)(1) of this section, the entity to which section 1557 applies (as
                defined in Sec. 92.3 of this part) shall provide:
                 (A) Real-time, audio over a dedicated high-speed, wide-bandwidth
                video connection or wireless connection that delivers high-quality
                audio without lags or irregular pauses in communication;
                 (B) A clear, audible transmission of voices; and
                 (C) Adequate training to users of the technology and other involved
                individuals so that they may quickly and efficiently set up and operate
                the remote interpreting services.
                 (4) Restricted use of certain persons to interpret or facilitate
                communication. If an entity is required by paragraph (a) of this
                section, in light of the entity's individualized assessment of the four
                factors set forth in paragraph (b)(1) of this section, to provide
                interpretation services, such entity shall not:
                 (i) Require an individual with limited English proficiency to
                provide his or her own interpreter;
                 (ii) Rely on an adult accompanying an individual with limited
                English proficiency to interpret or facilitate communication, except
                 (A) In an emergency involving an imminent threat to the safety or
                welfare of an individual or the public, where there is no qualified
                interpreter for the individual with limited English proficiency
                immediately available; or
                 (B) Where the individual with limited English proficiency
                specifically requests that the accompanying adult interpret or
                facilitate communication, the accompanying adult agrees to provide such
                assistance, and reliance on that adult for such assistance is
                appropriate under the circumstances;
                 (iii) Rely on a minor child to interpret or facilitate
                communication, except in an emergency involving an imminent threat to
                the safety or welfare of an individual or the public, where there is no
                qualified interpreter for the individual with limited English
                proficiency immediately available; or
                 (iv) Rely on staff other than qualified bilingual/multilingual
                staff to communicate directly with individuals with limited English
                proficiency.
                 (c) Acceptance of language assistance services is not required.
                Nothing in this section shall be construed to require an individual
                with limited English proficiency to accept language assistance
                services.
                Sec. 92.102 Effective communication for individuals with
                disabilities.
                 (a) Any entity operating or administering a program or activity
                under this part shall take appropriate steps to ensure that
                communications with individuals with disabilities are as effective as
                communications with others in such programs or activities, in
                accordance with the standards found at 28 CFR 35.160 through 35.164.
                Where the regulatory provisions referenced in this section use the term
                ``public entity,'' the term ``entity'' shall apply in its place.
                 (b) A recipient or State Exchange shall provide appropriate
                auxiliary aids and services, including interpreters and information in
                alternate formats, to individuals with impaired sensory, manual, or
                speaking skills, where necessary to afford such persons an equal
                opportunity to benefit from the service in question.
                 (1) Auxiliary aids and services include:
                 (i) Interpreters on-site or through video remote interpreting (VRI)
                services, as defined in 28 CFR 35.104 and 36.303(f); note takers; real-
                time computer-aided transcription services; written materials; exchange
                of written notes; telephone handset amplifiers; assistive listening
                devices; assistive listening systems; telephones compatible with
                hearing aids; closed caption decoders; open and closed captioning,
                including real-time captioning; voice, text, and video-based
                telecommunication products and systems, text telephones (TTYs),
                videophones, and captioned telephones, or equally effective
                telecommunications devices; videotext displays; accessible information
                and communication technology; or other effective methods of making
                aurally delivered information available to individuals who are deaf or
                hard of hearing; and
                 (ii) Readers; taped texts; audio recordings; Braille materials and
                displays; screen reader software; magnification software; optical
                readers; secondary auditory programs; large print materials; accessible
                information and communication technology; or other effective methods of
                making visually delivered materials available to individuals who are
                blind or have low vision.
                 (2) When an entity is required to provide an interpreter under
                paragraph (b) of this section, the interpreting service shall be
                provided to individuals free of charge and in a timely manner, via a
                remote interpreting service or an onsite appearance, by an interpreter
                who
                 (i) Adheres to generally accepted interpreter ethics principles,
                including client confidentiality; and
                 (ii) Is able to interpret effectively, accurately, and impartially,
                both receptively and expressively, using any necessary specialized
                vocabulary, terminology and phraseology.
                 (3) An interpreter for an individual with a disability for purposes
                of this section can include, for example, sign language interpreters,
                oral transliterators (individuals who represent or spell in the
                characters of another alphabet), and cued language transliterators
                (individuals who represent or spell by using a small number of
                handshapes).
                 (c) Disability means, with respect to an individual, a physical or
                mental impairment that substantially limits one or more major life
                activities of such individual; a record of such an impairment; or being
                regarded as having such an impairment, as defined and construed in the
                Rehabilitation Act, 29 U.S.C. 705(9)(B), which incorporates the
                definition of disability in the Americans
                [[Page 37247]]
                with Disabilities Act (ADA), as amended (42 U.S.C. 12102 et seq.).
                Where this part cross-references regulatory provisions that use the
                term ``handicap,'' ``handicap'' means ``disability'' as defined in this
                section.
                Sec. 92.103 Accessibility standards for buildings and facilities.
                 (a) Each facility or part of a facility in which health programs or
                activities are conducted that is constructed or altered by or on behalf
                of, or for the use of, a recipient or State Exchange shall comply with
                the 2010 Standards, if the construction or alteration was commenced
                after July 18, 2016, except that if a facility or part of a facility in
                which health programs or activities are conducted that is constructed
                or altered by or on behalf of, or for the use of, a recipient or State
                Exchange, was not covered by the 2010 Standards prior to July 18, 2016,
                such facility or part of a facility shall comply with the 2010
                Standards if the construction was commenced after January 18, 2018.
                Departures from particular technical and scoping requirements by the
                use of other methods are permitted where substantially equivalent or
                greater access to and usability of the facility is provided. All newly
                constructed or altered buildings or facilities subject to this section
                shall comply with the requirements for a ``public building or
                facility'' as defined in section 106.5 of the 2010 Standards.
                 (b) Each facility or part of a facility in which health programs or
                activities under this part are conducted that is constructed or altered
                by or on behalf of, or for the use of, a recipient or State Exchange in
                conformance with the 1991 Standards at appendix D to 28 CFR part 36 or
                the 2010 Standards shall be deemed to comply with the requirements of
                this section and with 45 CFR 84.23(a) and (b) with respect to those
                facilities, if the construction or alteration was commenced on or
                before July 18, 2016. Each facility or part of a facility in which
                health programs or activities are conducted that is constructed or
                altered by or on behalf of, or for the use of, a recipient or State
                Exchange in conformance with UFAS shall be deemed to comply with the
                requirements of this section and with 45 CFR 84.23(a) and (b), if the
                construction was commenced on or before July 18, 2016 and such facility
                was not covered by the 1991 Standards or 2010 Standards.
                 (c) For purposes of this part:
                 (1) ``1991 Standards'' refers to the 1991 Americans with
                Disabilities Act Standards for Accessible Design at appendix D to 28
                CFR part 36.
                 (2) ``2010 Standards'' refers to the 2010 ADA Standards for
                Accessible Design, as defined in 28 CFR 35.104.
                 (3) ``UFAS'' refers to the Uniform Federal Accessibility Standards
                as promulgated in 49 FR 31528 (Aug. 7, 1984).
                Sec. 92.104 Accessibility of information and communication
                technology.
                 (a) Entities required to comply with Sec. 92.2, unless otherwise
                exempted by this part, shall ensure that their health programs or
                activities provided through information and communication technology
                are accessible to individuals with disabilities, unless doing so would
                result in undue financial and administrative burdens or a fundamental
                alteration in the nature of the health programs or activities. When
                undue financial and administrative burdens or a fundamental alteration
                exist, the covered entity shall provide information in a format other
                than an electronic format that would not result in such undue financial
                and administrative burdens or a fundamental alteration, but would
                ensure, to the maximum extent possible, that individuals with
                disabilities receive the benefits or services of the health program or
                activity that are provided through information and communication
                technology.
                 (b) A recipient or State Exchange shall ensure that its health
                programs or activities provided through websites comply with the
                requirements of Title II of the Americans with Disabilities Act (42
                U.S.C. 12131 through 12165).
                 (c) For purposes of this part, ``information and communication
                technology'' (ICT) means information technology and other equipment,
                systems, technologies, or processes, for which the principal function
                is the creation, manipulation, storage, display, receipt, or
                transmission of electronic data and information, as well as any
                associated content. Examples of ICT include computers and peripheral
                equipment; information kiosks and transaction machines;
                telecommunications equipment; customer premises equipment;
                multifunction office machines; software; applications; websites;
                videos; and, electronic documents.
                Sec. 92.105 Requirement to make reasonable modifications.
                 Any entity to which section 1557 applies (as defined in Sec. 92.3
                of this part) shall make reasonable modifications to its policies,
                practices, or procedures when such modifications are necessary to avoid
                discrimination on the basis of disability, unless the covered entity
                can demonstrate that making the modifications would fundamentally alter
                the nature of the health program or activity. For the purposes of this
                section, the term ``reasonable modifications'' shall be interpreted in
                a manner consistent with the term as set forth in the regulation
                promulgated under Title II of the Americans with Disabilities Act, at
                28 CFR 35.130(b)(7).
                PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND
                INDIVIDUAL HEALTH INSURANCE MARKETS
                0
                15. The authority citation for part 147 continues to read as follows:
                 Authority: 42 U.S.C. 18021, 18031, 18041, 18044, 18054, 18061,
                18063, 18071, and 18082, 26 U.S.C. 36B, 31 U.S.C. 9701.
                0
                16. Amend Sec. 147.104 by revising paragraph (e) to read as follows:
                Sec. 147.104 Guaranteed availability of coverage.
                * * * * *
                 (e) Marketing. A health insurance issuer and its officials,
                employees, agents and representatives must comply with any applicable
                State laws and regulations regarding marketing by health insurance
                issuers and cannot employ marketing practices or benefit designs that
                will have the effect of discouraging the enrollment of individuals with
                significant health needs in health insurance coverage or discriminate
                based on an individual's race, color, national origin, present or
                predicted disability, age, sex, expected length of life, degree of
                medical dependency, quality of life, or other health conditions.
                * * * * *
                PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED
                STANDARDS UNDER THE AFFORDABLE CARE ACT
                Subpart B--General Standards Related to the Establishment of an
                Exchange
                0
                17. The authority citation for part 155 continues to read as follows:
                 Authority: 42 U.S.C. 18021-18024, 18031-18033, 18041-18042,
                18051, 18054, 18071, and 18081-18083.
                0
                18. Amend Sec. 155.120 by revising paragraph (c)(1)(ii) to read as
                follows:
                Sec. 155.120 Non-interference with Federal law and non-discrimination
                standards.
                * * * * *
                 (c) * * *
                 (1) * * *
                [[Page 37248]]
                 (ii) Not discriminate based on race, color, national origin,
                disability, age, or sex.
                * * * * *
                0
                 19. Amend Sec. 155.220 by revising paragraph (j)(2)(i) to read as
                follows:
                Sec. 155.220 Ability of States to permit agents and brokers to assist
                qualified individuals, qualified employers, or qualified employees
                enrolling in QHPs.
                * * * * *
                 (j) * * *
                 (2) * * *
                 (i) Provide consumers with correct information, without omission of
                material fact, regarding the Federally-facilitated Exchanges, QHPs
                offered through the Federally-facilitated Exchanges, and insurance
                affordability programs, and refrain from marketing or conduct that is
                misleading (including by having a direct enrollment website that HHS
                determines could mislead a consumer into believing they are visiting
                HealthCare.gov), coercive, or discriminates based on race, color,
                national origin, disability, age, or sex;
                * * * * *
                PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE
                CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
                0
                20. The authority citation for part 156 continues to read as follows:
                 Authority: 5 U.S.C. 552; 42 U.S.C. 300jj-11 and 300jj-14.
                0
                21. Amend Sec. 156.200 by revising paragraph (e) to read as follows:
                Sec. 156.200 QHP issuer participation standards.
                * * * * *
                 (e) Non-discrimination. A QHP issuer must not, with respect to its
                QHP, discriminate on the basis of race, color, national origin,
                disability, age, or sex.
                * * * * *
                0
                22. Amend Sec. 156.1230 by revising paragraph (b)(2) to read as
                follows:
                Sec. 156.1230 Direct enrollment with the QHP issuer in a manner
                considered to be through the Exchange.
                * * * * *
                 (b) * * *
                 (2) The QHP issuer must provide consumers with correct information,
                without omission of material fact, regarding the Federally-facilitated
                Exchanges, QHPs offered through the Federally-facilitated Exchanges,
                and insurance affordability programs, and refrain from marketing or
                conduct that is misleading (including by having a direct enrollment
                website that HHS determines could mislead a consumer into believing
                they are visiting HealthCare.gov), coercive, or discriminates based on
                race, color, national origin, disability, age, or sex.
                 Dated: May 20, 2020.
                Alex M. Azar II,
                Secretary of Health and Human Services.
                [FR Doc. 2020-11758 Filed 6-12-20; 4:15 pm]
                BILLING CODE 4153-01-P
                

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