[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Proposed Rules]
[Pages 47824-47920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16217]



[[Page 47823]]

Vol. 87

Thursday,

No. 149

August 4, 2022

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





Office of the Secretary





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42 CFR Parts 438, 440, et al.

45 CFR Parts 80, 84, 86, et al.





Nondiscrimination in Health Programs and Activities; Proposed Rule

  Federal Register / Vol. 87 , No. 149 / Thursday, August 4, 2022 / 
Proposed Rules  

[[Page 47824]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 438, 440, 457, and 460

Office of the Secretary

45 CFR Parts 80, 84, 86, 91, 92, 147, 155, and 156

[Docket ID: HHS-OS-2022-0012]
RIN: 0945-AA17


Nondiscrimination in Health Programs and Activities

AGENCY: Centers for Medicare and Medicaid Services; Office for Civil 
Rights (OCR), Office of the Secretary, HHS.

ACTION: Notice of proposed rulemaking; notice of Tribal consultation.

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SUMMARY: The Department of Health and Human Services (HHS or the 
Department) is issuing this proposed rule on Section 1557 of the 
Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits 
discrimination on the basis of race, color, national origin, sex, age, 
or disability in certain health programs and activities. Section 
1557(c) of the ACA authorizes the Secretary of the Department to 
promulgate regulations to implement the nondiscrimination requirements 
of Section 1557. The Department is also proposing to revise its 
interpretation regarding whether Medicare Part B constitutes Federal 
financial assistance for purposes of civil rights enforcement and to 
revise nondiscrimination provisions to prohibit discrimination on the 
basis of sexual orientation and gender identity in regulations issued 
by the Centers for Medicare & Medicaid Services (CMS) governing 
Medicaid and the Children's Health Insurance Program (CHIP); Programs 
of All-Inclusive Care for the Elderly (PACE); health insurance issuers 
and their officials, employees, agents, and representatives; States and 
the Exchanges carrying out Exchange requirements; agents, brokers, or 
web-brokers that assist with or facilitate enrollment of qualified 
individuals, qualified employers, or qualified employees; issuers 
providing essential health benefits; and qualified health plan issuers.

DATES: 
    Comments: Submit comments on or before October 3, 2022.
    Meeting: Pursuant to Executive Order 13175, Consultation and 
Coordination with Indian Tribal Governments, the Department of Health 
and Human Services' Tribal Consultation Policy, and the Department's 
Plan for Implementing Executive Order 13175, the Office for Civil 
Rights solicits input by tribal officials as we develop the 
implementing regulations for Section 1557 of the Affordable Care Act at 
45 CFR part 92. The Tribal consultation meeting will be held on August 
31, 2022, from 2 p.m. to 4 p.m. Eastern Daylight Time.

ADDRESSES: You may submit comments, identified by RIN Number 0945-AA17, 
by any of the following methods. Please do not submit duplicate 
comments.
    To participate in the Tribal consultation meeting, you must 
register in advance at https://www.zoomgov.com/meeting/register/vJIsfu-rqzksEl2T8gUp_lDrWBqkU0223CY.
    Federal Rulemaking Portal: You may submit electronic comments at 
https://www.regulations.gov by searching for the Docket ID number HHS-
OS-2022-0012. Follow the instructions for submitting electronic 
comments. If you are submitting comments electronically, the Department 
strongly encourages you to submit any comments or attachments in 
Microsoft Word format. If you must submit a comment in Adobe Portable 
Document Format (PDF), the Department strongly encourages you to 
convert the PDF to ``print-to-PDF'' format, or to use some other 
commonly used searchable text format. Please do not submit the PDF in a 
scanned format. Using a print-to-PDF format allows the Department to 
electronically search and copy certain portions of your submissions to 
assist in the rulemaking process.
    Regular, Express, or Overnight Mail: You may mail written comments 
to the following address only: U.S. Department of Health and Human 
Services, Office for Civil Rights, Attention: 1557 NPRM (RIN 0945-
AA17), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue 
SW, Washington, DC 20201.
    All comments received by the methods and due date specified above 
may be posted without change to content to https://www.regulations.gov, 
which may include personal information provided about the commenter, 
and such posting may occur after the closing of the comment period. 
However, the Department may redact certain non-substantive content from 
comments before posting, including threats, hate speech, profanity, 
graphic images, or individually identifiable information about a third-
party individual other than the commenter. In addition, comments or 
material designated as confidential or not to be disclosed to the 
public will not be accepted. Comments may be redacted or rejected as 
described above without notice to the commenter, and the Department 
will not consider in rulemaking any redacted or rejected content that 
would not be made available to the public as part of the administrative 
record.
    Because of the large number of public comments normally received on 
Federal Register documents, OCR is not able to provide individual 
acknowledgments of receipt.
    Please allow sufficient time for mailed comments to be received 
timely in the event of delivery or security delays.
    Please note that comments submitted by fax or email and those 
submitted after the comment period will not be accepted.
    Docket: For complete access to background documents or posted 
comments, go to https://www.regulations.gov and search for Docket ID 
number HHS-OS-2022-0012.

FOR FURTHER INFORMATION CONTACT:

Office for Civil Rights

    Dylan Nicole de Kervor, (202) 240-3110 or (800) 537-7697 (TDD), or 
via email at hhs.gov">1557@hhs.gov, for matters related to Section 1557.

Centers for Medicare & Medicaid Services

John Giles, (410) 786-5545, for matters related to Medicaid.
Emily King, 410-786-8537, for matters related to CHIP.
Timothy Roe, (410) 786-2006 for matters related to Programs of All-
Inclusive Care for the Elderly.
Becca Bucchieri, (301) 492-4341, Agata Pelka, (667) 290-9979, or Leigha 
Basini, (301) 492-4380, for matters related to 45 CFR 155.120, 155.220, 
156.125, 156.200, and 156.1230.
Lindsey Murtagh, (301) 492-4106, for matters related to 45 CFR 147.104.
Hannah Katch, (202) 578-9581, for general questions related to CMS 
amendments.

    Assistance to Individuals With Disabilities in Reviewing the 
Rulemaking Record: Upon request, the Department will provide an 
accommodation or auxiliary aid to an individual with a disability who 
needs assistance to review the comments or other documents in the 
public rulemaking record for the proposed regulations. To schedule an 
appointment for this type of accommodation or auxiliary aid, please

[[Page 47825]]

call (202) 240-3110 or (800) 537-7697 (TDD) for assistance or email 
hhs.gov">1557@hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Nondiscrimination in Health Programs and Activities
    A. Section 1557 Background and Rulemaking
    B. Summary of the Proposed Rule
II. Reasons for the Proposed Rulemaking
    A. The Scope of the 2020 Rule Is Not the Best Reading of the 
Affordable Care Act and Section 1557's Statutory Text
    B. The 2020 Rule's Preamble Does Not Reflect Recent Developments 
in Sex Discrimination Law
    C. The 2020 Rule Causes Unnecessary Confusion in Compliance
    D. Proposed Changes Are Consistent With the Statute and Will 
Further the Intended Purpose of the Statute
III. Nondiscrimination in Health Programs and Activities
    Subpart A--General Provisions
    Purpose and Effective Date (Sec.  92.1)
    Application (Sec.  92.2)
    Relationship to Other Laws (Sec.  92.3)
    Definitions (Sec.  92.4)
    Assurances Required (Sec.  92.5)
    Remedial Action and Voluntary Action (Sec.  92.6)
    Designation and Responsibilities of a Section 1557 Coordinator 
(Sec.  92.7)
    Policies and Procedures (Sec.  92.8)
    Training (Sec.  92.9)
    Notice of Nondiscrimination (Sec.  92.10)
    Notice of Availability of Language Assistance Services and 
Auxiliary Aids and Services (Sec.  92.11)
    Subpart B--Nondiscrimination Provisions
    Discrimination Prohibited (Sec.  92.101)
    Subpart C--Specific Applications to Health Programs and 
Activities
    Meaningful Access for Limited English Proficient Individuals 
(Sec.  92.201)
    Effective Communication for Individuals With Disabilities (Sec.  
92.202)
    Accessibility for Buildings and Facilities (Sec.  92.203)
    Accessibility of Information and Communication Technology for 
Individuals With Disabilities (Sec.  92.204)
    Requirement To Make Reasonable Modifications (Sec.  92.205)
    Equal Program Access on the Basis of Sex (Sec.  92.206)
    Nondiscrimination in Health Insurance Coverage and Other Health-
Related Coverage (Sec.  92.207)
    Prohibition on Sex Discrimination Related to Marital, Parental, 
or Family Status (Sec.  92.208)
    Nondiscrimination on the Basis of Association (Sec.  92.209)
    Use of Clinical Algorithms in Decision-Making (Sec.  92.210)
    Nondiscrimination in the Delivery of Health Programs and 
Activities Through Telehealth Services (Sec.  92.211)
    Subpart D--Procedures
    Enforcement Mechanisms (Sec.  92.301)
    Notification of Views Regarding Application of Federal 
Conscience and Religious Freedom Laws (Sec.  92.302)
    Procedures for Health Programs and Activities Conducted by 
Recipients and State Exchanges (Sec.  92.303)
    Procedures for Health Programs and Activities Administered by 
the Department (Sec.  92.304)
IV. Change in Interpretation--Medicare Part B Meets the Definition 
of Federal Financial Assistance
V. CMS Amendments
    A. Medicaid and Children's Health Insurance Program (CHIP)
    B. Programs of All-Inclusive Care for the Elderly (PACE)
    C. Insurance Exchanges and Group and Individual Health Insurance 
Markets
VI. Executive Order 12866 and Related Executive Orders on Regulatory 
Review
    A. Regulatory Impact Analysis
    B. Regulatory Flexibility Act--Initial Small Entity Analysis
    C. Executive Order 13132: Federalism
    D. Executive Order 12250 on Leadership and Coordination of 
Nondiscrimination Laws
VII. Request for Comment

I. Background

A. Section 1557 Background and Rulemaking

    In 2010, Congress passed and the President signed into law the 
Patient Protection and Affordable Care Act (ACA) \1\ to reform the 
country's health insurance system, making health care more affordable 
and accessible for tens of millions of persons in the United States. 
Among other things, the ACA provided health care access to many 
individuals by increasing coverage options and prohibiting 
discrimination in health care. Section 1557 of the ACA (Section 1557) 
is one of the government's most powerful tools to ensure access to and 
coverage of health care in a nondiscriminatory manner. Except as 
otherwise provided in Title I of the ACA, Section 1557 prohibits 
discrimination on the basis of race, color, national origin, sex, age, 
or disability in a health program or activity, any part of which is 
receiving Federal financial assistance, including credits, subsidies, 
or contracts of insurance. Section 1557 also prohibits discrimination 
on the basis of race, color, national origin, sex, age, or disability 
under any program or activity that is administered by an Executive 
Agency, or any entity established under Title I of the ACA or its 
amendments. The statute cites Title VI of the Civil Rights Act of 1964 
\2\ (Title VI), Title IX of the Education Amendments of 1972 \3\ (Title 
IX), the Age Discrimination Act of 1975 \4\ (Age Act), and Section 504 
of the Rehabilitation Act of 1973 \5\ (Section 504) to identify the 
grounds of discrimination prohibited by Section 1557. The statute 
further specifies that the enforcement mechanisms provided for and 
available under Title VI, Title IX, the Age Act, or Section 504 shall 
apply for purposes of violations of Section 1557.\6\ The statute 
authorizes the Secretary of the U.S. Department of Health and Human 
Services (HHS or the Department) to promulgate implementing regulations 
for Section 1557.\7\
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    \1\ The Patient Protection and Affordable Care Act, Public Law 
111-148, was enacted on March 23, 2010. The Healthcare and Education 
Reconciliation Act of 2010, Public Law 111-152, which amended and 
revised several provisions of the Patient Protection and Affordable 
Care Act, was enacted on March 30, 2010. In this rulemaking, the two 
statutes are referred to collectively as the ``Patient Protection 
and Affordable Care Act,'' ``Affordable Care Act,'' or ``ACA.''
    \2\ 42 U.S.C. 2000d et seq.
    \3\ 20 U.S.C. 1681 et seq.
    \4\ 42 U.S.C. 6101 et seq.
    \5\ 29 U.S.C. 794.
    \6\ 42 U.S.C. 18116(a).
    \7\ Id. 18116(c).
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    Section 1557 was effective upon enactment, and the Department's 
Office for Civil Rights (OCR) began enforcing the law immediately 
thereafter while drafting implementing regulations.\8\
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    \8\ See, e.g., Bulletin, U.S. Dep't of Health & Human Servs., 
The Brooklyn Hospital Center Implements Non-Discriminatory Practices 
to Ensure Equal Care for Transgender Patients (July 14, 2015), 
https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/statement.pdf; OCR Enforcement under Section 1557 of 
the Affordable Care Act Sex Discrimination Cases, U.S. Dep't of 
Health & Human Servs., https://www.hhs.gov/civil-rights/for-individuals/section-1557/ocr-enforcement-section-1557-aca-sex-discrimination/index.html (last updated Aug. 1, 2016); see also C.P. 
v. Blue Cross Blue Shield, 536 F. Supp. 3d 791, 796 (W.D. Wash. 
2021) (citing Tovar v. Essentia Health, 342 F. Supp. 3d 947, 957 (D. 
Minn. 2018) (stating ``[a] claim of discrimination in violation of 
Section 1557 does not depend on an HHS rule'' in denying a motion to 
dismiss a challenge to categorical exclusions for treatment for 
gender dysphoria in a health insurance plan); Prescott v. Rady 
Children's Hosp. of San Diego, 265 F. Supp. 3d 1090, 1098 (S.D. Cal. 
2017) (denying defendant hospital's motion to dismiss gender 
identity discrimination complaint under Section 1557 because 
Department regulations were not in effect at the time of the alleged 
discrimination, holding the claim of discrimination was grounded in 
the plain language of the statute).
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1. 2016 Rulemaking
    On August 1, 2013, the Department published a Request for 
Information in the Federal Register,\9\ followed by issuance of a 
Notice of Proposed Rulemaking (NPRM) on September 8, 2015 (2015 
NPRM).\10\ The Department finalized the Section 1557 regulation on

[[Page 47826]]

May 18, 2016 (2016 Rule).\11\ The 2016 Rule applied to all health 
programs and activities, any part of which received Federal financial 
assistance, and all health programs and activities administered by the 
Department or by an entity established under Title I of the ACA. The 
2016 Rule included provisions intended to provide, for covered health 
programs and activities, consistent requirements across all prohibited 
forms of discrimination including grievance procedures, designated 
employees to coordinate compliance with the law, and notice 
requirements. The 2016 Rule included a detailed definition section. The 
2016 Rule also required covered entities to provide, in ``significant 
communications,'' notice and information regarding the availability of 
language assistance services in the 15 most common languages spoken by 
limited English proficient \12\ (LEP) persons in each state. 
Additionally, it required covered entities to take reasonable steps to 
provide meaningful access to each LEP individual eligible to be served 
in covered entities' health programs and activities. It further 
prohibited discrimination on the basis of sex, including gender 
identity; outlined requirements for equal program access on the basis 
of sex; and explicitly prohibited discrimination in health-related 
insurance and other health-related coverage, including a ban on 
categorical exclusions of gender-transition-related care in health 
insurance coverage and other health-related coverage. At the time, 
though the Department supported a prohibition on discrimination based 
on sexual orientation as a matter of policy, the 2016 Rule did not 
explicitly prohibit discrimination on the basis of sexual orientation 
because no Federal appellate court had yet concluded that sex-based 
discrimination included sexual orientation discrimination.\13\ Instead, 
relying on the Supreme Court's opinion in Price Waterhouse v. 
Hopkins,\14\ the 2016 Rule explained that Section 1557's prohibition of 
discrimination on the basis of sex included sex discrimination related 
to an individual's sexual orientation where the evidence established 
that the discrimination was based on gender stereotypes.\15\ The 2016 
Rule explicitly exempted covered entities from complying with any 
requirements that would violate applicable Federal statutory 
protections for conscience and religious exercise.\16\
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    \9\ 78 FR 46558 (Aug. 1, 2013). Responses are available for 
public inspection at https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments.
    \10\ 80 FR 54171 (Sept. 8, 2015). The 2015 NPRM received roughly 
2,160 comments, which are available for public inspection at https://www.regulations.gov/docket/HHS-OCR-2015-0006/comments.
    \11\ 81 FR 31375 (May 18, 2016).
    \12\ In the Proposed Rule at Sec.  92.4, infra, a limited 
English proficient (LEP) individual means an individual whose 
primary language for communication is not English and who has a 
limited ability to read, write, speak, or understand English. An LEP 
individual may be competent in English for certain types of 
communication (e.g., speaking or understanding), but still be LEP 
for other purposes (e.g., reading or writing).
    \13\ 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.'').
    \14\ 490 U.S. 228, 250-51 (1989).
    \15\ 81 FR 31389, 31390.
    \16\ See former 45 CFR 92.2(b)(2). ``Insofar as application of 
any requirement under this part would violate applicable Federal 
statutory protections for religious freedom and conscience, such 
application shall not be required.''
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    The 2016 Rule had an effective date of July 18, 2016, except to the 
extent that the rule required changes to health insurance or group 
health plan benefits or benefit design, in which case the 2016 Rule 
applied on the first day of the first plan year that began on or after 
January 1, 2017.\17\
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    \17\ 81 FR 313756, 31378, 31430, 31466.
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    The 2016 Rule was challenged under the Administrative Procedure Act 
\18\ (APA) and the Religious Freedom Restoration Act \19\ (RFRA). 
Before the rule went into effect, the United States (U.S.) District 
Court for the Northern District of Texas, in Franciscan Alliance v. 
Burwell, enjoined the Department from enforcing the 2016 Rule's 
prohibition against discrimination on the basis of gender identity or 
termination of pregnancy.\20\ Subsequently, on October 15, 2019, the 
same district court vacated the 2016 Rule insofar as the 2016 Rule 
defined discrimination on the basis of sex to include gender identity 
and termination of pregnancy.\21\ In 2021, the court in Franciscan 
Alliance issued an order enjoining the Department from interpreting or 
enforcing Section 1557 against the plaintiffs in that case in a manner 
that would require them to perform or provide insurance coverage for 
gender transition services or abortion.\22\ In Religious Sisters of 
Mercy et al. v. Becerra et al., the court enjoined the Department from 
enforcing Section 1557 against the plaintiffs in that case in a manner 
that would require them to perform or provide insurance coverage for 
gender transition services.\23\ Both decisions have been appealed on 
standing and ripeness grounds, among other things. As of the 
publication of this NPRM, appeals are pending in the Fifth and Eighth 
Circuits. More recently, another district court in the District of 
North Dakota in Christian Employers Alliance v. U.S. Equal Employment 
Opportunity Commission et al. enjoined the Department from enforcing 
Section 1557 against the plaintiffs in that case in a manner that would 
require them to perform or provide insurance coverage for gender 
transition services or restrict or compel their speech on gender 
identity issues.\24\
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    \18\ 5 U.S.C. 551 et seq.
    \19\ 42 U.S.C. 2000bb et seq.
    \20\ Franciscan All., Inc. v. Burwell, 227 F. Supp. 3d 660 (N.D. 
Tex. 2016).
    \21\ Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928 (N.D. 
Tex. 2019).
    \22\ Franciscan All., Inc. v. Becerra, 553 F. Supp. 3d 361 (N.D. 
Tex. 2021), amended, No. 7:16-cv-00108-O, 2021 WL 6774686 (N.D. Tex. 
Oct. 1, 2021), appeal pending, No. 21-11174 (5th Cir. Nov. 21, 
2021).
    \23\ Religious Sisters of Mercy v. Azar, 513 F. Supp. 3d 1113 
(D.N.D. 2021), judgment entered sub nom. Religious Sisters of Mercy 
v. Cochran, No. 3:16-cv-00386, 2021 WL 1574628 (D.N.D. Feb. 19, 
2021), appeal pending, No. 21-1890 (8th Cir. April 20, 2021) (oral 
argument held Dec. 15, 2021).
    \24\ Christian Emp'rs All. v. EEOC, No. 21-cv-00195, 2022 WL 
1573689 (D.N.D. May 16, 2022).
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2. 2020 Rulemaking
    On June 14, 2019, the Department published a new Section 1557 
Notice of Proposed Rulemaking (2019 NPRM), proposing to rescind large 
portions of the 2016 Rule.\25\ Citing the Franciscan Alliance 
litigation, the 2019 NPRM proposed to rescind the 2016 Rule's 
definition of ``on the basis of sex,'' and, given ``the likelihood that 
the Supreme Court [would] be addressing the issue in the near future 
[in its Bostock v. Clayton County \26\ ruling],'' the preamble to the 
2019 NPRM proposed not to include a new definition for ``on the basis 
of sex.'' However, the preamble to the 2019 NPRM identified examples of 
other government entities that referred to ``sex'' in ``binary and 
biological'' terms and suggested that Section 1557's prohibition on sex 
discrimination may not extend to gender identity discrimination.\27\
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    \25\ 84 FR 27846 (June 14, 2019).
    \26\ 140 S. Ct. 1731 (2020).
    \27\ 84 FR 27853-55, 27856-57.
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    The 2019 NPRM also proposed to replace or rescind significant 
portions of the 2016 Rule in order to ``relieve billions of dollars in 
undue regulatory burdens,'' and ``eliminate provisions [of the 2016 
Rule] that are inconsistent or redundant with pre-existing civil rights 
statutes.'' \28\ The most common cost concern raised regarding the 2016 
Rule was the notice requirements at former Sec.  92.8, which required 
covered entities to include a notice of nondiscrimination and notice of 
the availability of language assistance services (``taglines'') in a 
range of communications.\29\
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    \28\ 84 FR 27848-49.
    \29\ See e.g., 84 FR 27857-58.
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    In addition, the 2019 NPRM proposed to eliminate the following 
provisions of the 2016 Rule: the definitions section, including the 
definition of ``health program or activity'' to include all of the

[[Page 47827]]

operations of an entity principally engaged in providing or 
administering health insurance or health-related coverage (former Sec.  
92.4); the requirement to designate a responsible employee to carry out 
a covered entity's responsibilities under Section 1557 (former Sec.  
92.7(a)); the requirement to adopt grievance procedures (former Sec.  
92.7(b)); notice and tagline requirements (former Sec.  92.8); the 
approach to accepting disparate impact claims with respect to 
allegations of sex discrimination (former Sec.  92.101(b)(3)(ii) and 
(iii)); the requirement for covered entities to justify sex-specific 
health programs or activities by demonstrating that the sex-specific 
health program or activity is substantially related to the achievement 
of an important health-related or scientific objective (former Sec.  
92.101(b)(3)(iv)); the requirement for a covered entity to take 
reasonable steps to provide meaningful access to each LEP individual 
(former Sec.  92.201(a)) (emphasis added); the prohibition on 
discrimination in health-related insurance and other health-related 
coverage, including a prohibition of blanket exclusions of coverage for 
care related to gender transition (former Sec.  92.207); the coverage 
of certain employee health benefit programs (former Sec.  92.208); the 
prohibition of discrimination on the basis of association (former Sec.  
92.209); reference to compensatory damages for Section 1557 violations 
to the extent such damages are available under underlying Federal civil 
rights statutes (former Sec.  92.301(b)); and the provision regarding 
the obligation to provide OCR access to review records and sources of 
information, and to otherwise comply with the Department's 
investigations (former Sec.  92.303(c)).
    On June 12, 2020, the Department publicly posted its second Section 
1557 Final Rule (2020 Rule), making no substantive changes from the 
2019 NPRM.\30\ On June 15, 2020, the U.S. Supreme Court issued its 
ruling in Bostock v. Clayton County, holding that discrimination on the 
basis of sexual orientation and gender identity constitutes prohibited 
discrimination because of sex under Title VII of the Civil Rights Act 
of 1964 (Title VII).\31\ The 2020 Rule was published in the Federal 
Register on June 19, 2020 with preamble language that was inconsistent 
with the Supreme Court's Bostock opinion.\32\
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    \30\ 85 FR 37160 (June 19, 2020) (``After considering public 
comments, in this final rule, the Department revises its Section 
1557 regulations . . . as proposed, with minor and primarily 
technical corrections.''). The 2019 NPRM received roughly 155,960 
comments, which are available for public inspection at https://www.regulations.gov/docket/HHS-OCR-2019-0007.
    \31\ 140 S. Ct. 1731 (2020).
    \32\ 85 FR 37178-37180.
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    Following the issuance of the 2020 Rule, which included an 
effective date of August 18, 2020,\33\ litigants in various U.S. 
District Courts sought to enjoin the rule on the basis that it was, 
among other allegations, arbitrary and capricious and contrary to law 
under the APA.\34\ While these challenges addressed a range of changes 
made to the 2016 Rule, they primarily focused on the 2020 Rule's repeal 
of the definition of ``on the basis of sex''; the incorporation of 
provisions governing the 2020 Rule's relationship to other laws related 
to various religious exemptions; the scope of coverage; and the 
elimination of language access provisions. As a result of these 
challenges, the Department is currently preliminarily enjoined from 
enforcing its repeal of certain portions of the 2016 Rule's definition 
of ``on the basis of sex,'' and of former 45 CFR 92.206, regarding 
equal program access on the basis of sex, as well as from enforcing the 
2020 Rule's incorporation of Title IX's religious exemption.\35\ The 
five pending lawsuits were stayed for the Department's review of the 
2020 Rule.
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    \33\ Id. at 37169.
    \34\ Walker v. Azar, No. 20-cv-2834 (E.D.N.Y. June 26, 2020); 
Whitman-Walker Clinic v. U.S. Dep't of Health & Human Servs., No. 
1:20-cv-01630 (D.D.C. June 22, 2020); N.Y. v. U.S. Dep't of Health & 
Human Servs., No. 1:20-cv-05583 (S.D.N.Y. July 20, 2020); BAGLY v. 
U.S. Dep't of Health & Human Servs., No. 20-cv11297 (D. Mass. July 
9, 2021); Chinatown Serv. Ctr. v. U.S. Dep't of Health & Human 
Servs., No. 1:21-cv-00331 (D.D.C. Oct. 13, 2021).
    \35\ Walker v. Azar, 480 F. Supp. 3d 417, 430 (E.D.N.Y. 2020) 
(enjoining repeal of definition of ``on the basis of sex,'' 
including sex stereotyping); Whitman-Walker Clinic v. U.S. Dep't of 
Health & Human Servs., 485 F. Supp. 3d 1 (D.D.C. 2020) (enjoining 
repeal of definition of ``on the basis of sex,'' insofar as it 
includes ``discrimination on the basis of . . . sex stereotyping'' 
and enjoining incorporation of Title IX religious exemption); Walker 
v. Azar, No. 20-cv-2834, 2020 WL 6363970, at *4 (E.D.N.Y. Oct. 29, 
2020) (enjoining repeal of former 45 CFR 92.206). The 2020 Rule 
provides that ``[i]nosofar as the application of any requirement 
under this part would violate, depart from, or contradict 
definitions, exemptions, affirmative rights, or protections provided 
by'' various statutes including Title IX's religious exemption, 
``such application shall not be imposed or required.'' 45 CFR 
92.6(b). Relying on language in the 2020 Rule's preamble, the 
Whitman-Walker court preliminarily construed Sec.  92.6(b) to 
explicitly incorporate Title IX's religious exemption. Whitman-
Walker Clinic, 485 F. Supp. 3d at 14, 43. These orders did not 
affect the district court's vacatur of the 2016 Rule insofar as it 
defined sex discrimination to include gender identity discrimination 
in Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928 (N.D. Tex. 
2019).
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3. May 10, 2021 Notification of Interpretation (``Bostock 
Notification'')
    On May 10, 2021, the Department publicly announced, consistent with 
the Supreme Court's decision in Bostock, that the Department would 
interpret Section 1557's prohibition on sex discrimination to include 
(1) discrimination on the basis of sexual orientation and (2) 
discrimination on the basis of gender identity (``Bostock 
Notification'').\36\ The Department explained that its interpretation 
will guide OCR's complaint processing and investigations; however, the 
interpretation did not ``determine the outcome in any particular case 
or set of facts.'' In addition, the Department explained that its 
Section 1557 enforcement will comply with RFRA and all other legal 
requirements, including applicable court orders that have been issued 
in litigation involving Section 1557 regulations.
---------------------------------------------------------------------------

    \36\ 86 FR 27984 (May 25, 2021) (U.S. Dep't of Health & Human 
Srvs.' Notification of Interpretation and Enforcement of Section 
1557 of the Affordable Care Act and Title IX of the Education 
Amendments of 1972). See also Hammons v. Univ. of Md. Med. Sys. 
Corp., 551 F. Supp. 3d 567, 590 (D. Md. 2021) (stating that Bostock 
``made clear that the position stated in HHS' [Bostock Notification] 
was already binding law.'').
---------------------------------------------------------------------------

    There are currently three court challenges to the Department's 
Bostock Notification, generally alleging violations of the APA and 
RFRA.\37\ As of this writing, two opinions have been issued: (1) the 
district court in Neese v. Becerra denied the defendants' motion to 
dismiss, finding that the plaintiffs plausibly pled that neither 
Section 1557 nor Bostock prohibit health care providers from 
discriminating on the basis of sexual orientation and gender 
identity,\38\ and (2) the district court in Christian Employers 
Alliance v. EEOC has preliminarily enjoined the Department from 
interpreting or enforcing Section 1557 and its implementing regulations 
against plaintiffs in a manner that would require them to provide, 
offer, perform, facilitate, or refer for gender transition services or 
that prevents, restricts or compels the plaintiffs' speech on gender 
identity issues.\39\ All three cases remain pending.
---------------------------------------------------------------------------

    \37\ Neese v. Becerra, No. 2:21-cv-00163-Z (N.D. Tex. Aug. 25, 
2021); Am. Coll. of Pediatricians v. Becerra, No. 1:21-cv-00195 
(E.D. Tenn. Aug. 27, 2021); Christian Emp'rs All. v. EEOC, No. 21-
cv-00195 (D.N.D. Oct. 18, 2021).
    \38\ No. 2:21-cv-00163-Z, 2022 WL 1265925, at *14 (N.D. Tex. 
Apr. 26, 2022).
    \39\ No. 21-cv-00195, 2022 WL 1573689, at *9 (D.N.D. May 16, 
2022).
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4. March 2, 2022 Notice and Guidance on Gender Affirming Care, Civil 
Rights, and Patient Privacy
    On March 2, 2022, the Department published guidance, consistent 
with the Bostock Notification, that Section 1557

[[Page 47828]]

prohibits discrimination on the basis of gender identity in access to 
covered health programs and activities.\40\ Specifically, the 
Department stated that ``[c]ategorically refusing to provide treatment 
to an individual based on their gender identity is prohibited 
discrimination. Similarly, federally funded covered entities 
restricting an individual's ability to receive medically necessary 
care, including gender-affirming care, from their health care provider 
solely on the basis of their sex assigned at birth or gender identity 
likely violates Section 1557.'' \41\ On March 31, 2022, the U.S. 
Department of Justice (DOJ) issued a letter to State Attorneys General 
addressing protections against unlawful discrimination based on gender 
identity, including protections afforded by Section 1557.\42\
---------------------------------------------------------------------------

    \40\ U.S. Dep't of Health & Human Servs., HHS Notice and 
Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy 
(Mar. 2, 2022), https://www.hhs.gov/sites/default/files/hhs-ocr-notice-and-guidance-gender-affirming-care.pdf.
    \41\ Id. at 2.
    \42\ Letter from Kristen Clarke, Assistant Att'y Gen., Civil 
Rights Div., U.S. Dep't of Justice, to State Att'ys Gen. (Mar. 31, 
2022), https://www.justice.gov/opa/press-release/file/1489066/download.
---------------------------------------------------------------------------

    There is currently one challenge to the Department's gender-
affirming care notice alleging violations of the APA.\43\ On May 26, 
2022, the district court denied Defendants' supplemental motion to 
dismiss, finding that the March 2, 2022 Notice and Guidance was a final 
agency action and that Plaintiff had stated a credible threat of 
enforcement.\44\
---------------------------------------------------------------------------

    \43\ First Amended Compl., Tex. v. EEOC, et al, No. 2:21-cv-
00194-Z (N.D. Tex. Mar. 9, 2022).
    \44\ Order, Tex. v. EEOC, et al, No. 2:21-cv-00194-Z (N.D. Tex. 
May 26, 2022).
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B. Summary of the Proposed Rule

    The Department proposes to revise the 2020 Rule to reinstate 
regulatory protections from discrimination on the basis of race, color, 
national origin, sex, age, or disability in covered health programs and 
activities, consistent with the statutory text of Section 1557 and 
Congressional intent.
    This proposed rule would reflect Section 1557's application to 
health programs and activities of the Department, which holds the 
Department accountable to the same standards of compliance with civil 
rights laws to which it holds recipients of Federal financial 
assistance. The proposed rule would also reinstate the rule clarifying 
that Section 1557 generally applies to many health insurance issuers 
and also prohibits discrimination in health insurance and other health-
related coverage,\45\ furthering a central goal of the ACA--to increase 
access to health-related coverage--by ensuring that Section 1557's 
robust civil rights protections apply to health insurance and other 
health-related coverage.
---------------------------------------------------------------------------

    \45\ The term ``health coverage'' generally refers to a 
``[l]egal entitlement to payment or reimbursement for your health 
care costs, generally under a contract with a health insurance 
company, a group health plan offered in connection with employment, 
or a government program like Medicare, Medicaid, or the Children's 
Health Insurance Program (CHIP).'' Glossary: Health coverage, 
HealthCare.gov, https://www.healthcare.gov/glossary/health-coverage/ 
(last visited June 15, 2022).
---------------------------------------------------------------------------

    The proposed rule also seeks to create consistent procedural 
requirements for covered health programs and activities by requiring 
grievance procedures (for employers with 15 or more employees), the 
designation of a responsible employee (for employers with 15 or more 
employees), and the affirmative provision of civil rights notices. The 
absence of such consistency leaves individuals with different 
procedural protections in covered programs and activities depending on 
whether their complaint is based on race, color, national origin, sex, 
age, and/or disability. Further, the Department proposes to require 
covered entities to have in place a set of policies and procedures to 
support compliance with Section 1557, and to train relevant staff on 
their respective policies and procedures. The Department also proposes 
notice requirements, striking a balance between concerns raised by 
covered entities in response to the 2016 Rule and the importance of 
providing the public with information about their civil rights. The 
rule also proposes to implement robust protections for LEP individuals 
that ensure each LEP person has meaningful access to covered health 
programs and activities. The Department also proposes to address 
nondiscrimination on the basis of sex, including gender identity and 
sexual orientation, consistent with Bostock and related case law, as 
well as subsequent Federal agency interpretations.\46\ Further, the 
rule proposes to ensure equal program access on the basis of sex and 
prohibit discrimination on the basis of sex related to marital, family, 
or parental status. The Department additionally proposes provisions 
related to nondiscrimination in the use of clinical algorithms in 
health care decision-making and in telehealth services.
---------------------------------------------------------------------------

    \46\ E.g., Memorandum from Pamela S. Karlan, Principal Deputy 
Assistant Att'y Gen., to Fed. Agency Civil Rights Dirs. & Gen. 
Counsels (Mar. 26, 2021) [hereinafter Karlan Memo], https://www.justice.gov/crt/page/file/1383026/download; 86 FR 32637 (June 
22, 2021) (U.S. Dep't of Educ., notice of interpretation).
---------------------------------------------------------------------------

    The Department further proposes to apply the provisions applicable 
to Title VI to administrative enforcement actions against recipients of 
Federal financial assistance (recipients) and State Exchanges 
concerning discrimination on the basis of race, color, national origin, 
sex, and disability, consistent with Section 504 \47\ and Title IX \48\ 
regulations. For administrative enforcement actions against recipients 
and State Exchanges concerning discrimination on the basis of age, the 
Department proposes to employ the procedural provisions that apply 
under the Age Act. The Department proposes to apply the federally 
conducted Section 504 enforcement mechanisms with respect to 
administrative enforcement actions against the Department, including 
the Federally-facilitated Exchanges. Additionally, the Department 
proposes to adopt a process by which recipients may inform the 
Department of their views that the application of a specific provision 
or provisions of this part to them would violate Federal conscience or 
religious freedom laws, so that the Department may, as appropriate, 
make a determination that recipients are exempt from, or entitled to a 
modification of the application of, a provision or provisions of this 
part.
---------------------------------------------------------------------------

    \47\ 45 CFR 84.61 (adopting the procedural provision of Title 
VI).
    \48\ Id. Sec.  86.71 (adopting the procedural provision of Title 
VI).
---------------------------------------------------------------------------

    The Department is proposing to revise its position regarding 
whether Medicare Part B payments constitute Federal financial 
assistance for purposes of Federal civil rights jurisdiction under 
Title VI, Section 504, Title IX, the Age Act, and Section 1557. The 
Department explains that payments made under the Medicare Part B 
program meet the longstanding definition of ``Federal financial 
assistance,'' and proposes necessary conforming amendments to the 
appendices of the implementing regulations for Title VI and Section 
504.
    Finally, the Department proposes to make limited amendments to the 
Centers for Medicare & Medicaid Services (CMS) Medicaid, Children's 
Health Insurance Program (CHIP), and Program of All-Inclusive Care for 
the Elderly (PACE) nondiscrimination regulatory provisions, as well as 
nondiscrimination provisions applicable to group and individual health 
insurance markets and Health Insurance Exchanges to clarify that 
discrimination on the basis of sex

[[Page 47829]]

includes discrimination on the basis of sexual orientation and gender 
identity.

II. Reasons for the Proposed Rulemaking

    The Department is undertaking this rulemaking to better align the 
Section 1557 regulation with the statutory text of 42 U.S.C. 18116, to 
reflect recent developments in civil rights case law, to address 
unnecessary confusion in compliance and enforcement resulting from the 
2020 Rule, and to better address issues of discrimination that 
contribute to negative health interactions and outcomes. Upon further 
consideration and informed by civil rights issues raised in the context 
of the coronavirus disease 2019 (COVID-19) pandemic, the Department 
believes that the 2020 Rule creates substantial obstacles to the 
Department's ability to address discrimination across the health 
programs and activities it financially supports or administers, thereby 
undermining the statutory purpose of Section 1557 and hindering the 
Department's mission of pursuing health equity and protecting public 
health.
    In developing this NPRM, the Department undertook a significant 
review of previous rulemaking and developments in civil rights law 
since the publication of both the 2016 and 2020 Final Rules. The 
Department also engaged in a series of listening sessions with a 
diverse range of stakeholder groups.\49\
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    \49\ A list of stakeholder groups and notes from these listening 
sessions and written materials provided during or after the 
listening sessions are attached to the docket of this proposed rule 
as a supplemental material at federalregister.gov.
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A. The Scope of the 2020 Rule Is Not the Best Reading of the Affordable 
Care Act and Section 1557's Statutory Text

    In the Department's view, the scope of application in the 2020 Rule 
is not the best reading of the statutory text of Section 1557 in two 
significant respects. First, the 2020 Rule applies to ``any program or 
activity administered by the Department under Title I of the [ACA].'' 
\50\ However, the statutory language provides that Section 1557's 
discrimination prohibitions apply to covered programs and activities 
that are ``administered by an Executive Agency or any entity 
established under this title.'' \51\ The operative word, ``or,'' 
distinguishes programs and activities operated by an Executive Agency 
from those operated by a Title I entity. The 2020 Rule, however, 
construes this language to cover only programs and activities 
administered by the Department under Title I of the ACA, and programs 
and activities administered by any entity established under Title I of 
the ACA.\52\ The reading of the statute in the 2020 Rule is strained, 
and the Department does not believe that the best way to resolve any 
ambiguity is to construe the phrase ``established under this title'' as 
modifying the phrase ``administered by an Executive Agency.'' The 
preamble to the 2020 Rule explained that its construction was ``at 
least as reasonable'' as the 2016 Rule's resolution of this issue.\53\ 
However, upon further analysis the Department now believes that the 
reading proposed herein, which does not limit application to only 
programs and activities administered by the Department under Title I of 
the ACA, better reflects the statutory language as well as Congress' 
intent.\54\
---------------------------------------------------------------------------

    \50\ 45 CFR 92.3(a)(2).
    \51\ 42 U.S.C. 18116(a) (emphasis added).
    \52\ 45 CFR 92.3(a)(2)-(3) (emphasis added).
    \53\ 85 FR 37160, 37170 (June 19, 2020).
    \54\ See, e.g., Griffin v. Breckenridge, 403 U.S. 88, 97 (1971) 
(civil rights statutes should be construed broadly); U.S. v. Price, 
383 U.S. 787, 801 (1966) (same); see also N. Haven Bd. of Educ. v. 
Bell, 456 U.S. 512, 521 (1982) (``[I]f we are to give Title IX the 
scope that its origins dictate, we must accord it a sweep as broad 
as its language.''); S. Rep. No. 64, 100th Cong., 2d Sess. 5-7 
(1988), reprinted in 1988 U.S.C.C.A.N. 3, 7-9 (statement of Sen. 
Humphrey stating that Title VI should be interpreted as broadly as 
necessary to eradicate discriminatory practices in programs that 
Federal funds supported).
---------------------------------------------------------------------------

    Second, the 2020 Rule limits Section 1557's application to health 
insurance by providing that ``for purposes of this part, an entity 
principally or otherwise engaged in the business of providing health 
insurance shall not, by virtue of such provision, be considered to be 
principally engaged in the business of providing health care.'' \55\ 
The statutory text of Section 1557 demonstrates Congress' intent to 
apply Section 1557 to health insurance. In the description of Federal 
financial assistance subject to Section 1557, the statute identifies 
three examples of Federal financial assistance, all of which pertain to 
health insurance: ``credits, subsidies, or contracts of insurance.'' It 
is logical to conclude that the inclusion of credits and subsidies in 
Section 1557's statutory language refers to the tax credits and cost-
sharing subsidies provided for under the same title of the ACA (Title 
I) to assist people in purchasing health insurance coverage. 
Additionally, as is discussed in detail in this preamble, in enacting 
the ACA, Congress demonstrated a clear intent to protect individuals 
from discrimination in health insurance and other health-related 
coverage. As a general matter, the fact that Section 1557 is contained 
within the ACA--a law that predominantly regulates health insurance--
indicates that Congress intended Section 1557 to apply to health 
insurance. Thus, the Department, upon further evaluation, believes the 
2020 Rule limits application to health insurance and other health-
related coverage in a manner inconsistent with the statute and 
Congressional intent.
---------------------------------------------------------------------------

    \55\ 45 CFR 92.3(c).
---------------------------------------------------------------------------

B. The 2020 Rule's Preamble Does Not Reflect Recent Developments in Sex 
Discrimination Law

    The 2020 Rule declined to adopt a definition of ``on the basis of 
sex,'' but the 2019 NPRM and the preamble to the 2020 Rule suggested 
that Section 1557's prohibition on sex discrimination may not extend to 
gender identity discrimination.\56\ The Supreme Court has now held that 
Title VII's prohibition of employment discrimination on the basis of 
sex encompasses discrimination based on sexual orientation and gender 
identity.\57\ The Court reasoned that, even if Congress understood that 
``the term `sex' in 1964 referred to `status as either male or female 
[as] determined by reproductive biology,' '' Title VII prohibits 
discrimination based on sexual orientation and gender identity.\58\ 
Since Bostock, two Federal courts of appeals have held that the plain 
language of Title IX's prohibition on sex discrimination must be read 
similarly.\59\ The DOJ has also taken this position in Title IX 
litigation.\60\
---------------------------------------------------------------------------

    \56\ 84 FR 27846, 27853-55, 27856-57 (June 14, 2019); 85 FR 
37178-79.
    \57\ Bostock v. Clayton Cty., 140 S. Ct. 1731 (2020).
    \58\ Id. at 1739-40, 1743.
    \59\ See Doe v. Snyder, 28 F.4th 103, 113-14 (9th Cir. 2022); 
Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d 586, 616 (4th Cir. 
2020), as amended (Aug. 28, 2020), cert. denied, 141 S. Ct. 2878 
(Mem) (2020).
    \60\ See, e.g., U.S. Dep't of Justice, En Banc Brief as Amicus 
of the United States, Adams v. Sch. Bd. of St. Johns Cty., No. 18-
13592, 22 (11th Cir. Nov. 26, 2021); U.S. Dep't of Justice, 
Statement of Interest of the United States, B.P.J. v. W. Va. Bd. of 
Educ., No. 2:21-cv-00316 (S.D.W. Va. June 17, 2021).
---------------------------------------------------------------------------

    On January 20, 2021, President Biden, in Executive Order (E.O.) 
13988, directed agencies to review all agency actions, including 
regulations, that prohibit discrimination on the basis of sex to 
determine if they were inconsistent with the Court's reasoning in 
Bostock.\61\ In response, the Department assessed its Section 1557 
regulation and enforcement policies and issued its Bostock 
Notification. As discussed previously, the Bostock Notification stated 
that the Department would interpret and enforce Section 1557's sex 
discrimination prohibitions

[[Page 47830]]

consistent with Bostock, while recognizing that the interpretation did 
not ``determine the outcome in any particular case or set of facts'' 
and that the Department would comply with RFRA and all other legal 
requirements.\62\ For these reasons and those described in this NPRM, 
the Department believes the understanding of sex discrimination 
described in the 2020 Rule's preamble \63\ is an inaccurate reading of 
the statute.
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    \61\ 86 FR 7023, 7023-24 (Jan. 25, 2021).
    \62\ 86 FR 27984; see also Karlan Memo, supra note 46.
    \63\ 85 FR 37160, 37178-79 (June 19, 2020).
---------------------------------------------------------------------------

    The 2020 Rule's preamble relied heavily on the 2016 injunction and 
2019 vacatur issued by the district court in the Franciscan Alliance 
case, which predated the Bostock decision, when removing the 2016 
Rule's gender identity provisions.\64\ The district court in that case 
found that Section 1557's prohibition of sex discrimination did not 
cover gender identity discrimination.\65\ Even prior to Bostock, a 
number of courts had reached a contrary conclusion and held that 
Federal sex discrimination protections, including Section 1557, 
provided protection to transgender and gender-nonconforming 
individuals, although the exact rationales used by these courts 
varied.\66\ Notably, the Bostock Court presumed for the sake of 
argument that ``sex'' referred only to ``biological distinctions 
between male and female'' and still found that Title VII's prohibition 
of sex discrimination prohibits discrimination on the basis of sexual 
orientation and gender identity.\67\ Following Bostock, courts have 
continued to hold that Federal sex discrimination protections, 
including Section 1557 and Title IX, cover gender identity 
discrimination.\68\ While some post-Bostock decisions have placed 
limits on Section 1557's application to discrimination against 
transgender people, these decisions have focused on whether RFRA 
exempts specific entities from potential future enforcement by HHS of 
Section 1557's requirements against them; for the most part they do not 
call into question Bostock's application to Section 1557.\69\ In its 
Bostock Notification, the Department affirmed its commitment to 
complying with RFRA and all other legal requirements supporting 
religious exercise and freedom of conscience while also affirming 
Section 1557's prohibition of discrimination on the basis of gender 
identity and sexual orientation.\70\
---------------------------------------------------------------------------

    \64\ 85 FR 37163-65 (citing Franciscan All., Inc. v. Burwell, 
227 F. Supp. 3d 660 (N.D. Tex. 2016) and Franciscan All., Inc. v. 
Azar, 414 F. Supp. 3d 928 (N.D. Tex. 2019)).
    \65\ Franciscan All., Inc. v. Burwell, 227 F. Supp. 3d at 688.
    \66\ See, e.g., Whitaker By Whitaker v. Kenosha Unified Sch. 
Dist. No. 1 Bd. of Educ., 858 F.3d 1034 (7th Cir. 2017) (Title IX); 
Smith v. City of Salem, Ohio, 378 F.3d 566 (6th Cir. 2004) (Title 
VII); Rosa v. Park W. Bank & Trust Co., 214 F.3d 213 (1st Cir. 2000) 
(Equal Credit Opportunity Act); Schroer v. Billington, 577 F. Supp. 
2d 293 (D.D.C. 2008) (Title VII); Boyden v. Conlin, 341 F. Supp. 3d 
979 (W.D. Wis. 2018) (Section 1557 and Title VII); Flack v. Wis. 
Dep't. of Health Servs., 395 F. Supp 3d 1001, 1014 (W.D. Wis. 2019) 
(Section 1557 and Equal Protection Clause); Prescott v. Rady 
Children's Hosp. San Diego, 265 F. Supp. 3d 1090, 1098-100 (S.D. 
Cal. 2017) (Section 1557); Tovar v. Essential Health, 342 F. Supp. 
3d 947, 957 (D. Minn. 2018) (Section 1557).
    \67\ Bostock v. Clayton Cty., 140 S. Ct. 1731, 1739 (2020).
    \68\ Doe v. Snyder, 28 F.4th 103, 113-14 (9th Cir. 2022); Grimm 
v. Gloucester Cty. Sch. Bd., 972 F.3d 586, 616 (4th Cir. 2020), as 
amended (Aug. 28, 2020), cert. denied, 141 S. Ct. 2878 (Mem) (2020); 
Kadel v. Folwell, No. 1:19-cv-00272, 2022 WL 2106270, at *28-*29 
(M.D.N.C. June 10, 2022); Scott v. St. Louis Univ. Hosp., No. 4:21-
cv-01270-AGF, 2022 WL 1211092, at *6 (E.D. Mo. Apr. 25, 2022); C.P. 
by & through Pritchard v. Blue Cross Blue Shield of Ill., No. 3:20-
cv-06145-RJB, 2021 WL 1758896, at *4 (W.D. Wash. May 4, 2021); 
Koenke v. Saint Joseph's Univ., No. CV 19-4731, 2021 WL 75778, at *2 
(E.D. Pa. Jan. 8, 2021); Doe v. Univ. of Scranton, No. 3:19-cv-
01486, 2020 WL 5993766, at *11 n.61 (M.D. Pa. Oct. 9, 2020); Maxon 
v. Seminary, No. 2:19-cv-9969, 2020 WL 6305460 (C.D. Cal. Oct. 7, 
2020); B.P.J. v. W. Va. State Bd. of Educ., No. 2:21-cv-00316, 2021 
WL 3081883, at *7 (S.D.W. Va. July 21, 2021); Clark Cty. Sch. Dist. 
v. Bryan, 478 P.3d 344, 354 (Nev. 2020).
    \69\ Franciscan All., Inc. v. Becerra, No. 7:16-cv-00108-O, 2021 
WL 3492338 (N.D. Tex. Aug. 9, 2021), as amended (Aug. 16, 2021), 
appeal pending, No. 21-11174 (5th Cir. Nov. 21, 2021); Religious 
Sisters of Mercy v. Azar, 513 F. Supp. 3d 1113 (D.N.D. 2021), 
judgment entered sub nom. Religious Sisters of Mercy v. Cochran, No. 
3:16-cv-00386, 2021 WL 1574628 (D.N.D. Feb. 19, 2021), appeal 
pending, No. 21-1890 (8th Cir. April 20, 2021) (oral argument held 
Dec. 15, 2021); but see Neese v. Becerra, No. 2:21-cv-00163-Z, 2022 
WL 1265925, at *14 (N.D. Tex. Apr. 26, 2022) (denying motion to 
dismiss based on possibility that neither Section 1557 nor Bostock 
prohibit health care providers from discriminating on the basis of 
sexual orientation and gender identity).
    \70\ 86 FR 27984. Three Federal district courts have enjoined 
the Department from enforcing Section 1557 in certain respects 
against the plaintiffs in those cases and their members. See 
Religious Sisters of Mercy, 513 F. Supp. at 1153-54; Franciscan 
All., Inc. v. Becerra, 553 F. Supp. 3d 361, 378 (N.D. Tex. 2021), 
amended, No. 7:16-CV-00108-O, 2021 WL 6774686 (N.D. Tex. Oct. 1, 
2021); Christian Emp'rs All. v. EEOC, No. 21-cv-00195, 2022 WL 
1573689 (D.N.D. May 16, 2022). The Department has appealed the 
injunctions in Religious Sisters of Mercy and Franciscan Alliance, 
and those appeals remain pending. The Department is currently 
abiding by those injunctions and will continue to do so after this 
Rule takes effect, to the extent those injunctions remain in place.
---------------------------------------------------------------------------

C. The 2020 Rule Causes Unnecessary Confusion in Compliance

    The 2020 Rule provides no guidance on how covered entities are to 
implement their compliance responsibilities under Section 1557 and, in 
particular, whether those responsibilities are the same as, or deviate 
from, their compliance responsibilities under Title VI, Title IX, 
Section 504, and the Age Act. Rather, it generally states the 
nondiscrimination requirements of Section 1557 by restating the 
statutory language of 42 U.S.C. 18116(a), followed by stating that the 
grounds prohibited are the grounds found in the Title VI, Title IX, 
Section 504, and Age Act statutes.\71\ The resulting uncertainty is 
particularly stark for procedural requirements--including the 
designation of a responsible employee, the provision of notices of 
nondiscrimination, and adoption of grievance procedures--as the 2020 
Rule removed the 2016 Rule provisions addressing these issues.
---------------------------------------------------------------------------

    \71\ 45 CFR 92.2.
---------------------------------------------------------------------------

    The implementing regulations for the statutes referenced in Section 
1557 require covered entities to have different policies and procedures 
depending on the alleged basis of discrimination. For example, only the 
regulations promulgated under Section 504 \72\ and Title IX \73\ 
require recipients to implement grievance procedures; regulations to 
implement Title VI and the Age Act specify no such regulatory 
requirement. Given that the 2020 Rule does not reference grievance 
procedures, covered entities are unsure of their responsibility to have 
a grievance procedure for handling complaints of discrimination in 
their health programs and activities. As such, it would be reasonable 
for a covered entity to believe that the 2020 Rule does not require 
such a procedure. However, a covered entity could also reasonably 
believe that it must have a grievance procedure to address allegations 
of disability and sex discrimination, as this is what is independently 
required under Section 504 and Title IX regulations, but not for 
complaints of race, color, national origin, or age discrimination 
because neither the Title VI nor Age Act regulations have such a 
requirement. To further complicate the issues, the requirement to have 
a grievance procedure under Section 504 is limited to covered entities 
that employ 15 or more people, whereas the Title IX regulation requires 
grievance procedures for covered entities regardless of the number of 
employees.
---------------------------------------------------------------------------

    \72\ Id. Sec.  84.7(b).
    \73\ Id. Sec.  86.8(b).
---------------------------------------------------------------------------

    As this discussion illustrates, the approach in the 2020 Rule has 
caused confusion in compliance by failing to provide clear procedural 
requirements. The 2020 Rule also significantly pared down regulatory 
language related to the specific discriminatory actions prohibited that 
one generally finds in an

[[Page 47831]]

implementing regulation for a civil rights statute.\74\ The Department 
believes covered entities and protected individuals need additional 
clarity regarding the specific discriminatory actions prohibited under 
Section 1557, including clarification regarding whether and how those 
actions found in the implementing regulations of the statutes 
referenced in Section 1557 may also apply.
---------------------------------------------------------------------------

    \74\ For example, the implementing regulations for each of 
Section 1557's referenced statutes include provisions describing 
specific actions that constitute prohibited discrimination. See 45 
CFR 80.3 (Title VI) Sec.  84.4 (504); Sec.  86.31 (Title IX); and 
Sec.  91.11 (Age Act). Consistent with these implementing 
regulations, the 2016 Rule included a comparable provision at former 
45 CFR 92.101, which the 2020 Rule repealed and purportedly replaced 
with Sec.  92.2, which does not identify specific, prohibited 
discriminatory actions. See 85 FR 37160, 37200 (June 19, 2020); 45 
CFR 92.2.
---------------------------------------------------------------------------

D. Proposed Changes Are Consistent With the Statute and Will Further 
the Intended Purpose of the Statute

    Despite the best efforts of many health care professionals, 
inequities in access to health care resulting in disparities in health 
status and outcomes persist. Such disparities pose a major public 
health challenge for the United States and hinder efforts by health 
care professionals who work to ensure that their patients receive 
quality care. As discussed throughout this preamble, discrimination in 
health care can contribute to these disparities, which negatively 
impacts communities of color, individuals with disabilities, women, 
lesbian, gay, bisexual, transgender,\75\ queer, and intersex \76\ 
(LGBTQI+) \77\ individuals, LEP individuals, and older adults and 
children. Critically, access to health care that is free from 
discrimination benefits all communities and people, and is also vital 
to addressing public health emergencies, such as the COVID-19 pandemic. 
For example, ensuring nondiscriminatory access to health care, 
vaccines, and protective equipment during a public health emergency 
will more effectively and expeditiously end the emergency for 
everyone.\78\
---------------------------------------------------------------------------

    \75\ When used in this preamble, the term ``transgender'' refers 
to people who identify as a gender other than their sex assigned at 
birth. This may include people who identify as nonbinary, 
genderqueer, or gender nonconforming, regardless of whether those 
individuals explicitly use the term transgender to describe 
themselves.
    \76\ When used in this preamble, the term ``intersex'' refers to 
people born with variations in physical sex characteristics--
including genitals, gonads, chromosomes, and hormonal factors--that 
do not fit typical binary definitions of male or female bodies.
    \77\ We use ``+'' in this acronym to indicate inclusion of 
individuals who may not identify with the listed terms but who have 
a different identity with regards to their sexual orientation, 
gender identity, or sex characteristics.
    \78\ See, e.g., Ann Lee & Sheila David, Ensuring Equitable 
Access to Vaccines, Stan. Soc. Innovation Rev., Jun. 29, 2021, 
https://ssir.org/articles/entry/ensuring_equitable_access_to_vaccines#.
---------------------------------------------------------------------------

    Strong civil rights protections play a significant role in 
advancing an equitable society, and every part of government must 
contribute to ensuring that people in the United States enjoy the 
protections guaranteed to them. Since taking office, President Biden 
has issued more than a dozen directives aimed at promoting equity, 
including the robust enforcement of civil rights.\79\ Discrimination in 
health programs and activities can lead to disparate health outcomes 
and adverse differences in access to care.\80\ Accordingly, the 
Department is committed to doing its part to eliminate such 
discrimination, including through robust implementation and enforcement 
of Section 1557. Moreover, the Department is committed to addressing 
different, intersecting forms of discrimination experienced by 
individuals who may be entitled to protection from discrimination on 
more than one of the protected bases under Section 1557 and whose 
experience of discrimination may be both quantitatively and 
qualitatively different from that of individuals experiencing single-
basis discrimination.
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    \79\ See, e.g., E.O. 13985, 86 FR 7009 (2021); E.O. 13988, 86 FR 
7023 (2021); E.O. 13995, 86 FR 7193 (2021); Memorandum on Redressing 
Our Nation's and the Federal Government's History of Discriminatory 
Housing Practices and Policies (2021), https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/26/memorandum-on-redressing-our-nations-and-the-federal-governments-history-of-discriminatory-housing-practices-and-policies/; Memorandum on 
Condemning and Combating Racism, Xenophobia, and Intolerance Against 
Asian Americans and Pacific Islanders in the United States (2021), 
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/26/memorandum-condemning-and-combating-racism-xenophobia-and-intolerance-against-asian-americans-and-pacific-islanders-in-the-united-states/; E.O. 14012, 86 FR 8722 (2021); E.O.14031, 86 FR 
29675 (2021); E.O. 14035, 86 FR 34593 (2021); E.O. 14041, 86 FR 
50443 (2021); E.O.14045, 86 FR 51581 (2021); and other Presidential 
Actions.
    \80\ 156 Cong. Rec. S1842 (daily ed. Mar. 23, 2010), https://www.congress.gov/congressional-record/2010/03/23/senate-section/article/S1821-6.
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1. Health Equity and Discrimination Related to Race, Color, and 
National Origin
    Members of racial and ethnic groups that have historically faced 
discrimination and structural disadvantages in the United States 
experience disproportionately poor health status.\81\ Though health 
indicators for aggregated racial and ethnic populations may suggest 
positive outcomes for some groups, broad demographic categories often 
conceal health disparities within and among racial and ethnic 
subgroups. For example, positive overall data on the health of persons 
of Asian descent often obscure disparities among subgroups.\82\ One 
study revealed that while Asian persons in the aggregate appeared to be 
healthier than white persons in the United States, disaggregation of 
the data shows that persons of Filipino descent experience a higher 
prevalence of fair or poor health, obesity, high blood pressure, 
diabetes, or asthma when compared with white persons.\83\ Similarly, 
while the rate of low birth weight infants is lower for the total 
Hispanic/Latino population in the United States in comparison to non-
Hispanic white people, Puerto Ricans have a low birth weight rate that 
is almost twice that of non-Hispanic white people.\84\
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    \81\ U.S. Dep't of Health & Human Servs., Office of Minority 
Health, Minority Population Profiles, https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=26 (last 
visited Nov. 9, 2021).
    \82\ Alexander Adia et al., Health Conditions, Outcomes, and 
Service Access Among Filipino, Vietnamese, Chinese, Japanese, and 
Korean Adults in California, 2011-2017, 110 a.m. J. of Pub. Health 
520 (2020), https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2019.305523.
    \83\ Id.
    \84\ U.S. Dep't of Health & Human Servs., Office of Minority 
Health, Profile: Hispanic/Latino Americans https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=64 (last visited 
Nov. 19, 2021).
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    Beyond poor health outcomes, communities of color in the United 
States have long experienced disparities in health care--including in 
health insurance coverage, access to care, quality of care, maternal 
mortality rates, and inclusion in biomedical research. For example, 
American Indian/Alaska Native, Black, and Hispanic/Latino adults 
account for a disproportionately high share of the uninsured 
population. American Indian/Alaska Native individuals under 65 have an 
uninsured rate of 28 percent, higher than any other racial or ethnic 
group.\85\ Hispanic/Latino people comprise 29 percent of the uninsured 
yet make up 19 percent of the U.S. population.\86\ These

[[Page 47832]]

disparities are particularly salient in states that did not expand 
Medicaid; 37 percent of the total uninsured Black population in the 
United States reside in just three such states.\87\
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    \85\ The U.S. Census does not classify the Indian Health Service 
as health coverage. U.S. Dep't of Health & Human Servs., Assistant 
Sec'y for Policy & Evaluation, Office of Health Policy, Issue Brief: 
Health Insurance Coverage and Access to Care for American Indians 
and Alaska Natives: Current Trends and Key Challenges, p. 1 (July 
22, 2021), aspe-aian-health-insurance-coverage-ib.pdf (hhs.gov).
    \86\ U.S. Dep't of Health & Human Servs., Assistant Sec'y for 
Policy & Evaluation, Office of Health Policy, Issue Brief: The 
Remaining Uninsured: Geographic and Demographic Variation, p. 1 
(Mar. 23, 2021), https://aspe.hhs.gov/sites/default/files/private/pdf/265286/Uninsured-Population-Issue-Brief.pdf.
    \87\ Id. at p. 8.
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    In addition to experiencing disparities in coverage, people of 
color are also more likely than white people to experience a lower 
quality of care. For example, HHS' 2021 National Health Care Quality 
and Disparities Report evaluated whether different racial groups 
received worse care than white individuals in the areas of patient 
safety, person-centered care, care coordination, the effectiveness of 
care, healthy living, and affordable care. The study found that Black 
individuals received worse care than white individuals for 43 percent 
of 195 quality measures, American Indian/Alaska Native individuals 
received worse care than white individuals for 40 percent of 108 
quality measures, Hispanic/Latino individuals received worse care than 
white individuals for 36 percent of 172 quality measures, Native 
Hawaiian/Pacific Islander individuals reported receiving a lower level 
of care than white people for 28 percent of 81 quality measures, and 
where Asian individuals received worse care than white individuals, it 
was for 28 percent of 173 quality measures.\88\ While many factors may 
contribute to these disparities, the report highlights the role of 
social determinants of health,\89\ which include racial and ethnic 
discrimination, limited English proficiency, and presence of health 
care laws.\90\
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    \88\ U.S. Dep't of Health & Human Servs., Agency for Healthcare 
Research & Quality, 2021 National Healthcare Quality and Disparities 
Report Executive Summary, pp. ES-3, D-3-D-51 (Dec. 2020), https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2021qdr.pdf.
    \89\ Social determinants of health are the conditions in the 
environments where people are born, live, learn, work, play, 
worship, and age that affect a wide range of health, functioning, 
and quality-of-life outcomes and risks. Social Determinants of 
Health, Healthy People 2030, U.S. Dep't of Health & Human Servs., 
Office of Disease Prevention & Health Promotion, https://health.gov/healthypeople/objectives-and-data/social-determinants-health (last 
visited January 21, 2022).
    \90\ U.S. Dep't of Health & Human Servs., Agency for Healthcare 
Research & Quality, 2019 National Healthcare Quality and Disparities 
Report Executive Summary, p. 7 (Dec. 2020), https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2019qdr-final-es-cs061721.pdf.
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    Further, the disparities in maternal mortality rates are alarming. 
According to National Vital Statistics System data, in 2020, the 
maternal mortality rate for non-Hispanic/Latino Black women was 55.3 
deaths per 100,000 live births, 2.9 times the rate for non-Hispanic/
Latino white women (19.1).\91\ This disparity is increasing, with 
maternal mortality rate increases between 2019 and 2020 for non-
Hispanic/Latino Black and Hispanic/Latino people.\92\ An analysis of 
vital statistics mortality data showing the cause of maternal deaths in 
the United States from 2016-2017 revealed maternal mortality for Black 
women largely resulted from conditions like preeclampsia and 
cardiomyopathy, and were believed to be preventable.\93\ This study 
also found an increased risk of maternal mortality from multiple causes 
in Black women, which indicates negative impacts of structural racism 
on health and health care in the United States. The Biden-Harris 
Administration has taken initial steps to address these longstanding 
disparities, issuing the first-ever Presidential proclamation observing 
Black Maternal Health Week \94\ and hosting the first-ever Federal 
``Maternal Health Day of Action,'' which included a nationwide call to 
action to reduce mortality. The Administration has also announced 
several key policy actions, including CMS' intention to propose the 
first-ever hospital quality designation specifically focused on 
maternity care.\95\
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    \91\ Donna L. Hoyert, U.S. Dep't of Health & Human Servs., Ctrs. 
for Disease Control & Prevention, Maternal Mortality Rates in the 
United States (Feb. 2022), https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/E-stat-Maternal-Mortality-Rates-2022.pdf.
    \92\ Id.
    \93\ Marian F. MacDorman et al., Racial and Ethnic Disparities 
in Maternal Mortality in the United States Using Enhanced Vital 
Records, 2016-2017, 111 a.m. J. Pub. Health 1673, 1671 (2021), 
https://ajph.aphapublications.org/doi/10.2105/AJPH.2021.306375.
    \94\ The White House Briefing Room, A Proclamation on Black 
Maternal Health Week, 2021 (April 13, 2021), www.whitehouse.gov/briefing-room/presidential-actions/2021/04/13/a-proclamation-on-black-maternal-health-week-2021/;see also, The White House Briefing 
Room, A Proclamation on Black Maternal Health Week, 2022 (April 8, 
2022), https://www.whitehouse.gov/briefing-room/presidential-actions/2022/04/08/a-proclamation-on-black-maternal-health-week-2022/.
    \95\ The White House Briefing Room, FACT SHEET: Biden-Harris 
Administration Announces Initial Actions to Address the Black 
Maternal Health Crisis (Apr. 13, 2021), www.whitehouse.gov/briefing-room/statements-releases/2021/04/13/fact-sheet-biden-harris-administration-announces-initial-actions-to-address-the-black-maternal-health-crisis./
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    While research is beginning to reveal more information about the 
potential causes of Black maternal mortality, less research exists 
about the causes of maternal mortality among American Indian/Alaska 
Native women. A recent study documented the available literature on 
American Indian/Alaska Native women and found that the three leading 
causes of maternal mortality among such women are hemorrhage, 
cardiomyopathies, and hypertensive disorders of pregnancy.\96\ The 
authors ultimately concluded that more research is needed to determine 
the root causes of maternal mortality among American Indian/Alaska 
Native women, but suggested that to reduce American Indian/Alaska 
Native maternal mortality and eliminate racial/ethnic disparities, 
provider-related factors including implicit bias must be addressed.\97\
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    \96\ Jennifer L. Heck et al., Maternal Mortality Among American 
Indian/Alaska Native Women: A Scoping Review. 30 J. of Women's 
Health 220, 229 (2021), https://www.liebertpub.com/doi/epdf/10.1089/jwh.2020.8890.
    \97\ Id. at 226.
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    Persistent bias and racism in the health care system, as well as 
across other social determinants of health, also contribute to health 
challenges for people of color. For example, one study showed that 
medical students and medical residents hold false beliefs about 
biological differences between Black people and white people, and these 
falsely held beliefs are associated with racial disparities in pain 
perception and treatment recommendation accuracy.\98\ A recent study 
analyzing patients' electronic health records (EHR) found that Black 
patients had disproportionately higher odds of being described with one 
or more negative descriptors in the history and notes of the EHR than 
their white counterparts.\99\ The authors note that this may indicate 
implicit racial bias against Black patients, potentially leading to 
stigmatizing Black patients and compromising the care they receive. A 
recent survey indicates that, shaped by these experiences and 
perceptions, most Black adults believe that racial discrimination is 
not uncommon in health care.\100\ Black adults, and Black women in 
particular, are more likely than white people to report certain 
negative health care experiences.\101\ Racism and discrimination 
experienced outside the health care setting may also affect the mental 
and physical well-being of individuals of color. For example, Black 
people who experience

[[Page 47833]]

racism were more likely to experience deteriorations in health that 
contribute to premature death, including increased risk of inflammation 
and chronic illness.\102\
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    \98\ Kelly M. Hoffman et al., Racial Bias in Pain Assessment and 
Treatment Recommendations, and False Beliefs About Biological 
Differences Between Blacks and Whites, 113 Proc. of the Nat'l Acad. 
of Sci. 4296, 4301 (2016), https://doi.org/10.1073/pnas.1516047113.
    \99\ Michael Sun et al., Negative Patient Descriptors: 
Documenting Racial Bias in the Electronic Health Record, 41 Health 
Affairs 203, 211 (2022), https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2021.01423.
    \100\ Liz Hamel et al., The Kaiser Family Found., The Undefeated 
Survey on Race and Health, p. 4 (2020), https://files.kff.org/attachment/Report-Race-Health-and-COVID-19-The-Views-and-Experiences-of-Black-Americans.pdf.
    \101\ Id. at 5.
    \102\ Jamila Taylor, The Century Found., Racism, Inequality, and 
Health Care for African Americans, p. 6 (2019), https://production-tcf.imgix.net/app/uploads/2019/12/19172443/AfAmHealth_Jamila_PDF.pdf.
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    It is well-documented that LEP people experience obstacles to 
accessing health care in the United States.\103\ Language barriers 
negatively affect LEP patients' ability to comprehend their diagnoses 
and understand medical instructions when they are delivered in English, 
and impact their comfort with post-discharge care regimens.\104\ For 
example, Hispanic/Latino LEP people report worse access to care and 
report the receipt of fewer preventive services than Hispanic/Latino 
people who speak English proficiently.\105\ For Asian Americans who are 
not proficient in English, language barriers are one of the most 
significant challenges to accessing health care, including making an 
appointment, communicating with health care professionals, and gaining 
knowledge about an illness.\106\ This is even more pronounced among 
older Asian Americans, who are more likely to have limited English 
proficiency.\107\ Studies show that LEP patients experience longer 
hospital stays--leading to a greater risk of line infections, surgical 
infections, falls, and pressure ulcers--when compared to English-
speaking patients.\108\ Because LEP patients have greater difficulty 
understanding medical instructions when those instructions are given in 
English, they are at higher risk of surgical delays and 
readmissions.\109\ Although the use of qualified interpreters is 
effective in improving care for LEP patients, some clinicians choose 
not to use them, fail to use them effectively, or rely instead on ad 
hoc interpreters--such as family members or untrained bilingual 
staff.\110\ However, in addition to posing legal and ethical concerns, 
ad hoc interpreters are more likely to make mistakes than professional 
interpreters.\111\ Also, clinicians with basic or intermediate non-
English spoken language skills often attempt to communicate with the 
patient on their own without using an interpreter, increasing patient 
risk.\112\ These barriers contribute to disparities in health outcomes 
for LEP individuals, which have likely worsened during the COVID-19 
pandemic.\113\
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    \103\ Jason Espinoza et al., How Should Clinicians Respond to 
Language Barriers that Exacerbate Health Inequity?, 23 a.m. Med. 
Ass'n J. of Ethics E109 (2021) (LEP patients and families in the 
U.S. ``face barriers to health service access, experience lower 
quality care, and suffer worse health outcomes''), https://journalofethics.ama-assn.org/sites/journalofethics.ama-assn.org/files/2021-02/cscm3-2102.pdf.
    \104\ Id.; see also Leah S. Karliner et al., Convenient Access 
to Professional Interpreters in the Hospital Decreases Readmission 
Rates and Estimated Hospital Expenditures for Patients with Limited 
English Proficiency, 55 Med. Care 199 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5309198/.
    \105\ Espinoza, supra note 103.
    \106\ Wooksoo Kim et al., Barriers to Healthcare Among Asian 
Americans, 25 Soc. Work in Pub. Health 286, 289 (2010), https://www.tandfonline.com/doi/pdf/10.1080/19371910903240704?needAccess=true.
    \107\ Id.
    \108\ U.S. Dep't of Health & Human Servs., Agency for Healthcare 
Research & Quality, Executive Summary: Improving Patient Safety 
Systems for Patients with Limited English Proficiency (Sept. 2020), 
https://www.ahrq.gov/health-literacy/professional-training/lepguide/exec-summary.html#what.
    \109\ Id.
    \110\ Espinoza, supra note 103, at 110.
    \111\ See, e.g., Glenn Flores et al., Errors of Medical 
Interpretation and Their Potential Clinical Consequences: A 
Comparison of Professional Versus Ad Hoc Versus No Interpreters, 5 
Annals of Emerg. Med. 545 (Nov. 1, 2012), https://pubmed.ncbi.nlm.nih.gov/22424655/; Ali Labaf et al., The Effect of 
Language Barrier and Non-Professional Interpreters on the Accuracy 
of Patient-Physician Communication in Emergency Department, 3 Adv. 
J. Emerg. Med., June 6, 2019, at p. 4, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789075/pdf/AJEM-3-e38.pdf.
    \112\ U.S. Dep't of Health & Human Servs., Agency for Healthcare 
Research & Quality, supra note 108.
    \113\ See Lala Tanmoy Das et al., Addressing Barriers to Care 
for Patients with Limited English Proficiency During the COVID-19 
Pandemic, Health Affairs Blog (July 29, 2020), https://www.healthaffairs.org/do/10.1377/hblog20200724.76821/full/.
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2. Health Equity and Discrimination Related to Sex
    Disparities in women's health are well-documented. For example, 
although heart disease is the leading cause of death for men and women 
in the United States, women are more likely to experience delays in 
emergency care and treatment to control their cholesterol levels.\114\ 
Women are also more likely than men to die from a heart attack.\115\ 
The delay in the diagnosis and treatment of heart disease is just one 
of many disparities women experience in health care settings. Some 
evidence suggests that women treated by male physicians for heart 
attacks experience higher rates of mortality compared to women treated 
by a female physician or by a male physician who has had more exposure 
to female patients and female physicians.\116\
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    \114\ What Health Issues or Conditions Affect Women Differently 
than Men?, U.S. Dep't of Health & Human Servs., Nat'l Inst. of Child 
Health & Human Dev., https://www.nichd.nih.gov/health/topics/womenshealth/conditioninfo/howconditionsaffect (last visited Mar. 
15, 2022).
    \115\ Brad Greenwood et al., Patient-Physician Gender 
Concordance and Increased Mortality Among Female Heart Attack 
Patients, 115 Proc. Nat'l Acad. Sci. 8569, 8574 (2018), https://www.pnas.org/doi/epdf/10.1073/pnas.1800097115.
    \116\ Id.
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    Studies regarding pain management have also indicated the risk of 
gender bias, based on the notion that men and women are ``separate and 
different in manners and needs,'' with a review of the literature 
revealing studies that show women receive less adequate pain 
medication, more antidepressants, and more mental health referrals 
compared to men.\117\ Studies indicate this may have to do with 
erroneous gender stereotypes that men are ``stoic, in control, and 
avoid[] seeking health care,'' whereas women are presented as ``more 
sensitive to pain and more willing to show and to report pain'' 
compared to men.\118\
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    \117\ Anke Samulowitz 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 
Res. & Mgmt., Feb. 25, 2018, at pp. 1, 9-10, https://downloads.hindawi.com/journals/prm/2018/6358624.pdf; see also 
Danielle M. Wesolowicz et al., The Roles of Gender and Profession on 
Gender Role Expectations of Pain in Health Care Professionals, 11 J. 
of Pain Res. 1121 (2018), https://www.dovepress.com/getfile.php?fileID=42642.
    \118\ Samulowitz, supra note 117, at pp. 1, 9.
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    LGBTQI+ individuals in the United States also face pervasive health 
disparities and barriers in accessing needed health care. Throughout 
this preamble, we will use the full acronym of LGBTQI+ when talking 
broadly about individuals who are LGBTQI+ but will use a subset of the 
acronym (e.g., ``LGB,'' ``LGBT'' or ``LGBTQ'') when discussing studies, 
research, or concepts that apply only to a subset of this group.
    Overall, LGBTQI+ individuals report being in poorer health than 
non-LGBTQI+ individuals. LGBTQ+ individuals, moreover, are at increased 
risk for or are particularly affected by certain health conditions, 
including sexually transmitted infections,\119\ Human Immunodeficiency 
Virus (HIV),\120\ obesity,\121\ conditions associated with tobacco, 
alcohol, and other substance use,\122\ and mental

[[Page 47834]]

health conditions,\123\ including suicidality.\124\ LGB people are more 
likely to acquire a disability at a younger age than heterosexual 
individuals.\125\
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    \119\ Hilary Daniel et al., Annals of Internal Med. Position 
Papers, Lesbian, Gay, Bisexual, and Transgender Health Disparities: 
Executive Summary of a Policy Position Paper from the American 
College of Physicians (2015), https://www.acpjournals.org/doi/full/10.7326/M14-2482?journalCode=aim.
    \120\ U.S. Dep't of Health & Human Servs., Ctrs. for Disease 
Control & Prevention, HIV Surveillance Report, 2019; Vol. 32, pp. 
19, 24, 46 (2021), https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-updated-vol-32.pdf.
    \121\ Daniel, supra note 119.
    \122\ Id.
    \123\ Charlotte Patterson et al., Nat'l Acads. of Sci., Eng'g, & 
Med., Understanding the Well-Being of LGBTQI+ Populations, p. 298 
(2020), https://doi.org/10.17226/25877.
    \124\ Daniel, supra note 119.
    \125\ Id.
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    Discrimination also poses a major challenge to the health of 
LGBTQI+ people. A 2018 literature review revealed that 82 percent of 
studies found ``robust evidence that discrimination on the basis of 
sexual orientation or gender identity is associated with harms to the 
health of LGBT people.'' \126\ Anti-LGBT discrimination is associated 
with a higher risk of poor mental and physical health, including 
depression, anxiety, post-traumatic stress disorder, substance use, and 
cardiovascular disease.\127\ These effects are exacerbated for youth 
and people of color who identify as LGBT.\128\ Significant proportions 
of LGBTQ people report negative experiences with doctors and other 
health care providers.\129\ According to a recent survey, negative 
experiences with providers occur at higher rates among transgender 
people, particularly transgender people of color, than among other 
LGBTQ subgroups.\130\
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    \126\ What We Know Project, Cornell U., What Does the Scholarly 
Research Say About the Effects of Discrimination on the Health of 
LGBT People (2019), https://whatweknow.inequality.cornell.edu/wp-content/uploads/2019/12/LGBT-Discrimination-Printable-Findings-121319.pdf.
    \127\ Lesbian, Gay, Bisexual, and Transgender Health, 
HealthyPeople.gov, https://healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health (last visited June 
8, 2022).
    \128\ Id.; see also Bianca D.M. Wilson et al., The Williams 
Inst., UCLA Sch. of Law, Racial Differences Among LGBT Adults in the 
US: LGBT Well-Being at the Intersection of Race (2022), https://williamsinstitute.law.ucla.edu/wp-content/uploads/LGBT-Race-Comparison-Jan-2022.pdf.
    \129\ Sharita Gruberg et al., Ctr. for Am. Progress, The State 
of the LGBTQ Community in 2020 (2020), https://www.americanprogress.org/issues/lgbtq-rights/reports/2020/10/06/491052/state-lgbtq-community-2020/.
    \130\ Sandy E. James et al., Nat'l Ctr. for Transgender 
Equality, The Report of the 2015 U.S. Transgender Survey, p. 97 
(2016), https://transequality.org/sites/default/files/docs/usts/USTS-Full-Report-Dec17.pdf.
---------------------------------------------------------------------------

    With respect to transgender individuals, the Department believes 
that it is particularly important to acknowledge that evidence 
demonstrates that some health care providers have discriminated against 
and continue to discriminate against transgender people based on their 
gender identities. Transgender people commonly report that their 
providers asked them unnecessarily invasive questions about their 
gender identity; were physically or verbally abusive; refused them 
gender-affirming care; or refused to see them at all due to their 
gender identity.\131\ In some cases, transgender people and their 
providers face discriminatory obstacles at the hospitals or health 
systems where those providers work or have admitting privileges.\132\ 
Fear of disrespect and discrimination leads many LGBTQI+ people to 
report delaying or forgoing needed health care, especially for those 
who identify as transgender.\133\ While there is less published 
research addressing discrimination and disparate health outcomes in 
individuals with intersex conditions, preliminary studies suggest many 
of the same concerns and disparities apply.\134\
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    \131\ Id. at pp. 96-97.
    \132\ See, e.g., Chico Harlan, A Small-Town Doctor Wanted to 
Perform Surgeries for Transgender Women. He Faced an Uphill Battle, 
Wash. Post (Nov. 11, 2017), https://www.washingtonpost.com/national/a-small-town-doctor-wanted-to-perform-surgeries-for-transgender-women-he-faced-an-uphill-battle/2017/11/11/c6073a0a-c3d7-11e7-84bc-5e285c7f4512_story.html.
    \133\ Patterson, supra note 123, at p. 292.
    \134\ Laetitia Zeeman & Kay Aranda, A Systematic Review of the 
Health and Healthcare Inequalities for People with Intersex 
Variance, 17 Int'l J. of Envtl. Res. & Pub. Health 6533 (2020), 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559554/; Amy 
Rosenwohl-Mack et al., A National Study on the Physical and Mental 
Health of Intersex Adults in the U.S., 15 PLoS ONE, Oct. 9, 2020, 
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240088.
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    LGBTQI+ people also face barriers to obtaining health insurance, 
which can impact their access to appropriate health care. Insured rates 
for LGB+ people have risen substantially since the implementation of 
the ACA coverage expansions, yet research indicates that some of these 
gains in coverage were lost between 2016 and 2019.\135\ Although 
research suggests that transgender people have benefited from the ACA's 
coverage expansions and consumer protections,\136\ significant 
disparities persist in the uninsured rate for transgender people when 
compared to cisgender \137\ people. Nearly one in five transgender 
adults reported that they lacked insurance from 2017-2018.\138\ 
Furthermore, transgender people who can access insurance may 
nonetheless be denied coverage for needed services, including gender-
affirming care.\139\ For example, more than 40 percent of transgender 
respondents in one survey said their health insurance company denied 
them coverage for a gender-affirming surgery; a similar proportion 
reported that they were denied coverage for hormone therapy.\140\
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    \135\ U.S. Dep't of Health & Human Servs., Assistant Sec'y for 
Policy & Evaluation, Office of Health Policy, Issue Brief: Health 
Insurance Coverage and Access to Care for LGBTQ+ Individuals: 
Current Trends and Key Challenges, p. 4 (June 2021), https://aspe.hhs.gov/sites/default/files/2021-07/lgbt-health-ib.pdf.
    \136\ Gruberg, supra note 129.
    \137\ The term ``cisgender'' refers to a person whose gender 
identity is the same as the person's assigned sex at birth.
    \138\ Wyatt Koma et al., The Kaiser Family Found., Demographics, 
Insurance Coverage, and Access to Care Among Transgender Adults 
(2020), https://www.kff.org/health-reform/issue-brief/demographics-insurance-coverage-and-access-to-care-among-transgender-adults/.
    \139\ For purposes of this preamble, the term ``gender-affirming 
care'' refers to care for transgender individuals (including those 
who identify using other terms, for example, nonbinary or gender 
nonconforming) that may include, but is not necessarily limited to, 
counseling, hormone therapy, surgery, and other services designed to 
treat gender dysphoria or support gender affirmation or transition. 
Gender-affirming care may also be, but is not necessarily, referred 
to as ``gender-affirming health services'' or ``transition-related 
care.'' The terms ``gender-affirming care'' or ``transition-related 
care'' also include care sought by individuals with intersex 
conditions who seek treatment for gender dysphoria. See World Prof. 
Ass'n for Transgender Health, Standards of Care for the Health of 
Transsexual, Transgender, and Gender-Nonconforming People, pp. 68-71 
(7th Version 2012) [hereinafter WPATH Standards], https://www.wpath.org/media/cms/Documents/SOC%20v7/SOC%20V7_English2012.pdf?_t=1613669341 (last visited Feb. 7, 2022).
    \140\ Gruberg, supra note 129.
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    Recent research confirms that the COVID-19 pandemic has also 
exacerbated the health disparities identified above for LGBTQI+ people. 
Specifically, LGBTQ+ people, who have a higher prevalence of underlying 
health conditions, are more susceptible to COVID-related illnesses and 
death.\141\ Another study revealed that LGBT+ people, in general, have 
experienced increased negative mental health impacts during the COVID-
19 pandemic compared with non-LGBT+ people.\142\ LGBTQ+ youth, in 
particular, may have experienced increased negative mental health 
impacts during the pandemic based on increased feelings of isolation 
and the inability to access supportive community groups and LGBTQ+ 
friendly spaces resulting from stay-at-home orders and social 
distancing

[[Page 47835]]

recommendations.\143\ These youth may also face familial rejection and 
related mental health and other consequences.\144\ Compared to non-
LGBT+ people, larger shares of LGBT+ people reported COVID-related 
employment disruptions.\145\ Thus, accessing and affording mental 
health care \146\ and health insurance generally \147\ during the 
pandemic is disproportionally more difficult for LGBT+ people compared 
to their numbers in the general population.
---------------------------------------------------------------------------

    \141\ Dustin Nowaskie & Anna Roesler, The Impact of COVID-19 on 
the LGBTQ+ Community: Comparisons Between Cisgender, Heterosexual 
People, Cisgender Sexual Minority People, and Gender Minority 
People, 309 Elsevier Psychiatry Res., Jan. 10, 2022, at pp. 1, 3, 
www.sciencedirect.com/science/article/pii/S0165178122000051.
    \142\ Lindsey Dawson et al., Kaiser Family Found., The Impact of 
the COVID-19 Pandemic on LGBT+ People's Mental Health (2021), 
https://www.kff.org/other/issue-brief/the-impact-of-the-covid-19-
pandemic-on-lgbt-peoples-mental-health/
#:~:text=LGBT%20people%20reported%20the%20COVID,rates%20than%20non%2D
LGBT%20people.
    \143\ Ishaan Sachdeva et al., Letter to the Editor: The 
Disparities Faced by the LGBTQ+ Community in Times of COVID-19, 297 
Elsevier Psychiatry Res., Jan. 14, 2021, https://www.sciencedirect.com/science/article/pii/S0165178121000226; Laurie 
A. Drabble & Michael J. Eliason, Introduction to Special Issue: 
Impacts of the COVID-19 Pandemic on LGBTQ+ Health and Well-Being, 68 
J. Homosexuality 545, 549 (2021), https://www.tandfonline.com/doi/pdf/10.1080/00918369.2020.1868182?needAccess=true; Scott Emory Moore 
et al., Disproportionate Impact of the COVID-19 Pandemic on 
Perceived Social Support, Mental Health and Somatic Symptoms in 
Sexual and Gender Minority Populations, 68 J. Homosexuality 577, 587 
(2021), www.tandfonline.com/doi/full/10.1080/00918369.2020.1868184.
    \144\ Sachdeva, supra note 143.
    \145\ Dawson, supra note 142.
    \146\ Nowaskie, supra note 141, at p. 3; see also Brad Sears et 
al., Williams Inst., UCLA Sch. of L., The Impact of the Fall 2020 
COVID-19 Surge on LGBT Adults in the U.S., p. 10 (2021), https://williamsinstitute.law.ucla.edu/wp-content/uploads/COVID-LGBT-Fall-Surge-Feb-2021.pdf.
    \147\ Drabble, supra note 143, at 548.
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3. Health Equity and Discrimination Related to Age
    Although the health disparities discussed above exist in all age 
groups, older adults experience unique age-related discrimination that 
negatively impacts their health. There is evidence that age 
discrimination has negative effects on the physical and mental health 
of older adults,\148\ including fatigue, pain, cognitive impairment, 
depression, and anxiety.\149\ Older adults have reported discrimination 
including providers disregarding their knowledge of their own health 
care needs, having their pain ignored for prolonged periods of time, 
and providers assuming that as older adults they are cognitively 
compromised or unable to communicate their medical concerns.\150\ Some 
older adults also report being disrespected, rushed, and ignored by 
their health care providers.\151\ One study on age discrimination found 
that one in 17 adults over the age of 50 experience frequent age 
discrimination in health care settings, and this is associated with a 
new or worsened disability within four years.\152\
---------------------------------------------------------------------------

    \148\ David Burnes et al., Interventions to Reduce Ageism 
Against Older Adults: A Systematic Review and Meta-Analysis, 109 Am. 
J. of Pub. Health, e1, e9 (2019), https://doi.org/10.2105/AJPH.2019.305123.
    \149\ Why Ageism in Health Care Is a Growing Concern, 
RegisCollege.edu, https://online.regiscollege.edu/blog/why-ageism-in-health-care-is-a-growing-concern/ (last visited Apr. 20, 2022).
    \150\ Judith Graham, `They Treat Me Like I'm Old and Stupid': 
Seniors Decry Health Providers' Age Bias, Kaiser Health News (Oct. 
20, 2021), https://khn.org/news/article/ageism-health-care-seniors-decry-bias-inappropriate-treatment/.
    \151\ Id.
    \152\ Stephanie E. Rogers et al., Discrimination in Healthcare 
Settings is Associated with Disability in Older Adults: Health and 
Retirement Study, 2008-2012, 30 J. Gen. Intern. Med., 1413, 1420 
(2015), https://doi.org/10.1007/s11606-015-3233-6.
---------------------------------------------------------------------------

    Health care disparities for older adults were tragically amplified 
by the impact of COVID-19. Recent data show that individuals 65 and 
older account for 74.3 percent of COVID-19 deaths in the United 
States.\153\ Older adults in nursing homes in particular faced far 
worse outcomes. Older adults who require a nursing home level of care 
account for only about 2 percent of the Medicare population but 
represented about 22 percent of all COVID-19 cases from March 2020 
through December 2020.\154\ Across all demographic breakdowns, nursing 
home beneficiaries of Medicare had much higher rates of COVID-19 than 
beneficiaries in the community, with Hispanic/Latino, Black, and Asian 
American nursing home beneficiaries having the highest rates.\155\ 
Similarly, nursing home residents were 12 times more likely to be 
hospitalized with COVID-19 \156\ and 43 percent died within 30 days of 
hospitalization as compared to 22 percent of the individuals admitted 
from the community.\157\ Thus, older adults in nursing homes were dying 
at higher rates than the general population and disproportionate to 
their numbers in the general population. Studies suggest that 
longstanding concerns associated with institutionalization such as 
crowding, understaffing, and facilities with fewer resources and 
oversight contributed to the devastating COVID-19 health disparities 
for older adults in nursing homes.\158\
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    \153\ U.S. Dep't of Health & Human Servs., Ctrs. for Disease 
Control & Prevention, COVID-19 Mortality Overview, Provisional Death 
Counts for Coronavirus Disease 2019, https://www.cdc.gov/nchs/covid19/mortality-overview.htm (last visited Feb. 16, 2022).
    \154\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & 
Medicaid Servs., The Impact of COVID-19 on Medicare Beneficiaries in 
Nursing Homes, https://www.cms.gov/medicare-covid-19-nursing-home-analysis (last visited Mar. 15, 2022).
    \155\ Id.
    \156\ Id.
    \157\ Id.
    \158\ See, e.g., Fangli Geng et al., Daily Nursing Home Staffing 
Levels Highly Variable, Often Below CMS Expectations, 38 Health 
Affairs 1095, 1099 (2019), https://doi.org/10.1377/hlthaff.2018.05322.
---------------------------------------------------------------------------

    Older adults of color sometimes experience discrimination in health 
care settings because of their age and their race. A recent study found 
that one in four Black and Hispanic/Latino adults in the U.S. age 60 
and older reported that they have been treated unfairly or have felt 
that their health concerns were not taken seriously by health 
professionals because of their racial or ethnic background.\159\ The 
findings from the report also stated that more than a quarter of U.S. 
older adults said they did not get the care or treatment they believed 
they needed,\160\ and U.S. older adults who have experienced 
discrimination in a health care setting were more likely to have worse 
health status, face economic hardships, and be more dissatisfied with 
their care than those who did not experience discrimination.\161\
---------------------------------------------------------------------------

    \159\ Michelle M. Doty et al., Commonwealth Fund, How 
Discrimination in Health Care Affects Older Americans, and What 
Health Systems and Providers Can Do (2022), https://doi.org/10.26099/yffm-2x15.
    \160\ Id.
    \161\ Id.
---------------------------------------------------------------------------

    Additionally, even though life expectancy and overall health have 
improved in recent years for most older Americans, with the exception 
of what we have seen during the COVID-19 pandemic where older Americans 
have been disproportionately negatively impacted, not all older adults 
are benefitting equally because of factors such as race, gender, and 
disability. For example, it is expected Hispanic/Latino and Black 
people will experience the largest increases in Alzheimer's disease and 
related dementias between 2015 and 2060.\162\ Additionally, women are 
nearly two times more likely to be affected by Alzheimer's disease than 
men.\163\ A recent survey commissioned by the Alzheimer's Association 
found that the ability to obtain a diagnosis, manage the disease, and 
access care and support services for dementia vary widely depending on 
race, ethnicity, geography, and socioeconomic status.\164\ These 
disparities reach beyond clinical care to include uneven representation 
of Black, Hispanic/Latino, Asian American and American Indian/Alaska 
Native populations in Alzheimer's research and clinical trials as 
well.\165\
---------------------------------------------------------------------------

    \162\ Minorities and Women Are at Greater Risk for Alzheimer's 
Disease, U.S. Dep't of Health & Human Servs., Ctrs. for Disease 
Control & Prevention, https://www.cdc.gov/aging/publications/features/Alz-Greater-Risk.html (last visited Mar. 15, 2022).
    \163\ Id.
    \164\ Alzheimer's Ass'n, Special Report: Race, Ethnicity and 
Alzheimer's in America, p. 72 (2021), https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special-report.pdf.
    \165\ Id.

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[[Page 47836]]

    Another age group disadvantaged by health disparities is children. 
Social determinants of health such as racism and poverty have been 
shown to have profoundly negative effects on the health status of 
children and adolescents. Research on the relationship between the 
impact of racism and the biological effects of chronic exposure to 
stress hormones at the cellular level reveals links between birth 
disparities and mental health challenges in youth.\166\
---------------------------------------------------------------------------

    \166\ Maria Trent et al., The Impact of Racism on Child and 
Adolescent Health, 144 Am. Acad. of Pediatrics, Aug. 1, 2019, 
https://publications.aap.org/pediatrics/article/144/2/e20191765/38466/The-Impact-of-Racism-on-Child-and-Adolescent.
---------------------------------------------------------------------------

    Additionally, the relationship between health disparities and the 
ability of low-income populations to access safe, healthy homes is 
well-documented. As early as 2005, the Office of the U.S. Surgeon 
General reported that 14 percent of low-income renters lived in homes 
with severe to moderate structural problems including water leaks and 
mold growth triggering allergic reactions and asthma attacks in 
residents.\167\ Exposure to lead in water sources and paint, soil, and 
dust particles are known to cause neurological disorders and increased 
risks of learning and intellectual disabilities in children.\168\ Data 
from national health surveys reveal that children of color, low-income 
families, and certain geographic regions are disproportionately 
impacted by lead poisoning.\169\ Specifically, Black children are the 
most likely to have higher blood lead levels, children living in 
poverty are more likely to have lead in their bodies than other 
children (regardless of their race/ethnicity or age of the home), and 
the Southern region of the United States has the highest number of 
children with lead exposure.\170\
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    \167\ U.S. Dep't of Health & Human Servs., Office of the Surgeon 
Gen., The Surgeon General's Call to Action to Promote Healthy Homes 
(2009), https://www.ncbi.nlm.nih.gov/books/NBK44192/pdf/Bookshelf_NBK44192.pdf.
    \168\ Health Effects of Lead Exposure, U.S. Dep't of Health & 
Human Servs., Ctrs. for Disease Control & Prevention, https://www.cdc.gov/nceh/lead/prevention/health-effects.htm (last visited 
Mar. 15, 2022).
    \169\ See, e.g., Eric M. Roberts et al., Assessing Child Lead 
Poisoning Case Ascertainment in the US, 1999-2010, 139 Pediatrics, 
May 2017, https://publications.aap.org/pediatrics/article/139/5/e20164266/38761/Assessing-Child-Lead-Poisoning-Case-Ascertainment; 
Who is Vulnerable to Childhood Lead Poisoning, Tracking California, 
https://www.trackingcalifornia.org/childhood-lead-poisoning/who-is-vulnerable-to-childhood-lead-poisoning (last visited Mar. 15, 2022).
    \170\ See, e.g., Roberts, supra note 169; Who is Vulnerable to 
Childhood Lead Poisoning, supra note 169.
---------------------------------------------------------------------------

4. Health Equity and Discrimination Related to Disability
    Individuals with disabilities face barriers to accessing health 
care and fare worse on a broad range of health indicators than the 
general population.\171\ In addition to experiencing disparate health 
outcomes and disparate social determinants of health, individuals with 
disabilities experience challenges in getting the health care they 
need. For example, standard medical diagnostic equipment is often 
inaccessible to individuals with mobility-related disabilities. As a 
result, as many as 20 million adults in the United States who have a 
disability that limits their functional mobility may experience 
challenges accessing preventive, primary, and specialty care due to the 
lack of accessible medical diagnostic equipment.\172\ Lack of physical 
access may lead to poor quality of care, ``delayed and incomplete care, 
missed diagnoses, exacerbation of the original disability, and 
increases in the likelihood of the development of secondary 
conditions.'' \173\
---------------------------------------------------------------------------

    \171\ See, e.g., Valerie L. Forman-Hoffman et al., Disability 
Status, Mortality, and Leading Causes of Death in the United States 
Community Population, 53 Med Care 346 (2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5302214/; Gloria L. Krahn et 
al., Persons with Disabilities as an Unrecognized Health Disparity 
Population, 205 Am. J. Pub. Health S198 (Apr. 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355692/; 2020 Topics and 
Objectives: Disability and Health, HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health (last visited Nov. 10, 2021); Elham Mahmoudi & Michelle 
Meade, Disparities in Access to Health Care Among Adults with 
Physical Disabilities: Analysis of a Representative National Sample 
for a Ten-Year Period, 8 Disability Health J. 182 (2015), https://pubmed.ncbi.nlm.nih.gov/25263459/.
    \172\ Debra L. Brucker & Andrew J. Houtenville, People with 
Disabilities in the United States, 96 Archives of Physical Medicine 
and Rehabilitation 771 (2015), https://doi.org/10.1016/j.apmr.2015.02.024.
    \173\ Nat'l Council on Disability, Enforceable Accessible 
Medical Equipment Standards: A Necessary Means to Address the Health 
Care Needs of People with Mobility Disabilities, p. 7 (2021), 
https://ncd.gov/sites/default/files/Documents/NCD_Medical_Equipment_Report_508.pdf.
---------------------------------------------------------------------------

    Disability-based bias and discrimination in the health care setting 
likely contribute to access issues faced by individuals with 
disabilities. A recent survey of U.S. physicians' perceptions of 
individuals with disabilities shows the prevalence of potentially 
biased views. For example, 82.4 percent of respondents in a study 
published in 2021 reported that individuals with significant 
disabilities have worse quality of life than those without 
disabilities, and only 40.7 percent were very confident about their 
ability to provide the same quality of care to patients with 
disabilities.\174\ Other studies confirm that some health care 
providers are likely to deny needed medical care to individuals with 
disabilities, substitute their own judgment for the preferences of 
patients with disabilities, and exhibit other forms of implicit and 
explicit bias.\175\
---------------------------------------------------------------------------

    \174\ Lisa I. Iezzoni et al., Physicians' Perceptions of People 
with Disability and Their Health Care, 40 Health Affairs 297 (2021), 
https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01452. See 
also, Lisa I. Iezzoni et al., US Physicians' Knowledge About the 
Americans with Disabilities Act and Accommodation of Patients with 
Disability, 41 Health Affairs 96 (2022), https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2021.01136.
    \175\ Kenneth A. Gerhart et al., Quality of Life Following 
Spinal Cord Injury: Knowledge of Attitudes of Emergency Care 
Providers, 24 Annals of Emergency Med. 807 (1994), https://www.annemergmed.com/article/S0196-0644(94)70318-3/fulltext; David 
Carlson et al., Nat'l Disability Rights Network, Devaluing People 
with Disabilities: Medical Procedures that Violate Civil Rights, pp. 
17, 23, 28, 42-43, 49, 54 (2012), https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf; Laura 
VanPuymbrouck et al., Explicit and Implicit Disability Attitudes of 
Healthcare Providers, 65 Rehab. Psychology 101 (2020), https://pubmed.ncbi.nlm.nih.gov/32105109/.
---------------------------------------------------------------------------

    Compared to individuals without disabilities, people with 
disabilities are more likely to have unmet medical, dental, and 
prescription medication needs--especially women with disabilities and 
individuals with disabilities who have lower incomes.\176\ Individuals 
with disabilities are also less likely to receive preventive health 
care services, such as routine teeth cleanings and cancer 
screenings.\177\ One study of Medicare beneficiaries with disabilities 
found that they were significantly more likely to report difficulty 
accessing care and more likely to lack annual clinician evaluation and 
management visits for primary and specialty care than those without 
disabilities.\178\ The same beneficiaries were also more likely to have 
general, nonemergent, and preventable emergency department visits.\179\ 
Female Medicare beneficiaries with disabilities aged 65 and older were 
found less likely to receive mammography screening

[[Page 47837]]

compared to female beneficiaries of the same age reporting no 
disability.\180\
---------------------------------------------------------------------------

    \176\ Andr[eacute]s J. Gallegos, Misperceptions of People with 
Disabilities Lead to Low-Quality Care: How Policy Makers Can Counter 
that Harm and Injustice, Health Affairs Blog (Apr. 1, 2021), https://www.healthaffairs.org/do/10.1377/hblog20210325.480382/full/.
    \177\ 2020 Topics and Objectives: Disability and Health, 
HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health (last visited Nov. 10, 2021).
    \178\ Kenton J. Johnson et al., Ambulatory Care Access and 
Emergency Department Use for Medicare Beneficiaries With and Without 
Disabilities, 40 Health Affairs 910 (2021), https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.01891.
    \179\ Id.
    \180\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & 
Medicaid Servs., Medicare Current Beneficiary Survey (2013), https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-ADA-2017.pdf.
---------------------------------------------------------------------------

    A recent study examined the intersectionality of disability and 
pregnancy and how this may impact risk for maternal morbidity and 
mortality, thereby underscoring the importance of ensuring 
nondiscrimination against women with disabilities.\181\
---------------------------------------------------------------------------

    \181\ Caroline Signore et al., The Intersection of Disability 
and Pregnancy: Risks for Maternal Morbidity and Mortality. 30 J. of 
Women's Health 147, 153 (2021), https://doi.org/10.1089/jwh.2020.8864.
---------------------------------------------------------------------------

    The COVID-19 pandemic exacerbated existing health disparities and 
uniquely affected individuals with disabilities, who are more likely to 
have pre-existing health conditions and face barriers to accessing 
health care, placing them at increased risk of COVID-19 infection and 
death.\182\ Further, some people who have been infected with COVID-19 
continue to experience symptoms that can last months after first being 
infected, or may have new or recurring symptoms at a later time, a 
condition known as ``long COVID'' that itself can constitute a 
disability.\183\ During the course of the COVID-19 pandemic, OCR has 
received a number of complaints from aging and disability rights 
advocates raising concerns that resource allocation decisions under 
state Crisis Standards of Care were being made in a manner that was 
discriminatory on the basis of age and disability. OCR provided 
technical assistance to a number of states to prevent resource 
allocation decisions from being made on the basis of discriminatory 
criteria.\184\
---------------------------------------------------------------------------

    \182\ Sabrina Epstein et al., New Obstacles and Widening Gaps: A 
Qualitative Study of the Effects of the COVID-19 Pandemic on U.S. 
Adults with Disabilities, 14 Disability & Health J. 101103 (2021), 
https://doi.org/10.1016/j.dhjo.2021.101103.
    \183\ U.S. Dep't of Health & Human Servs. & U.S. Dep't of 
Justice, Guidance on ``Long Covid'' as a Disability Under the ADA, 
Section 504, and Section 1557 (July 26, 2022), https://www.hhs.gov/about/news/2021/07/26/hhs-doj-issue-guidance-on-long-covid-and-disability-rights.html.
    \184\ Civil Rights and COVID-19, U.S. Dep't of Health & Human 
Servs., Office for Civil Rights, https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html (last updated July 26, 
2021); Bulletin, U.S. Dep't of Health & Human Servs., Office for 
Civil Rights, Civil Rights, HIPAA, and the Coronavirus Disease 2019 
(Mar. 28, 2020), https://www.hhs.gov/sites/default/files/ocr-bulletin-3-28-20.pdf.
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5. Improving the Nation's Health Through Civil Rights Protections
    The Department is committed to doing its part to address health 
disparities and to promote equity in health care access through a range 
of initiatives, including through implementation and enforcement of 
Section 1557's protections. As reviewed above, the 2016 Rule provided 
clarity regarding Section 1557's strong statutory protections from 
discrimination and equipped the Department with the means to enforce 
these protections. The 2020 Rule, by contrast, limited the Rule's 
scope, removed principal provisions from the Section 1557 regulation, 
and left ambiguity regarding the extent of various protections. The 
2020 Rule removed specific provisions implementing nondiscrimination 
protections regarding gender identity. The 2020 Rule also eliminated 
specific provisions addressing discrimination in health insurance 
coverage benefit design and eliminated provisions designed to ensure 
access to language assistance services for LEP individuals. 
Furthermore, 2020 Rule also narrowed the regulation's application to 
some, but not all, operations of health insurance issuers and to only 
certain programs administered by the Department.
    The 2020 Rule's removal of specific nondiscrimination provisions 
from the Section 1557 regulation--including the provision implementing 
protections based on gender identity discrimination, as well as other 
changes that could be read to limit the reach of Section 1557--has the 
potential to increase the incidence of discrimination for groups 
protected under the statute. As described above, discrimination leads 
to negative impacts on access to care and mental and physical health 
outcomes. An increase in discrimination will widen existing disparities 
and harm the well-being of underserved and historically marginalized 
individuals and communities. The Department acknowledges the potential 
interest that covered entities and other stakeholders may have in 
maintaining the 2020 Rule and recognizes that some of the proposed 
revisions reflect changes to certain positions articulated in that 
Rule. However, the Department is also cognizant of the fact that absent 
revisions to the 2020 Rule, protected groups likely will be relegated 
to inferior health care access without strong civil rights protections 
at a moment when health disparities have been magnified by the unequal 
burden of the COVID-19 pandemic.

III. Nondiscrimination in Health Programs and Activities

Subpart A--General Provisions

Purpose and effective date (Sec.  92.1)

    Proposed Sec.  92.1(a) states that the purpose of this part is to 
implement Section 1557, which prohibits discrimination in certain 
health programs and activities on the grounds prohibited under Title 
VI, Title IX, the Age Act, or Section 504. As discussed further in the 
Preamble's discussion of proposed Sec.  92.2, HHS interprets Section 
1557's prohibition of discrimination on the ``ground[s] prohibited'' 
under Title VI, Title IX, Age Act, or Section 504 to mean that Section 
1557 prohibits discrimination based on race, color, national origin, 
sex, age, or disability.\185\ In addition to incorporating the 
``ground[s] prohibited'' by these other statutes, Section 1557 
incorporates the ``enforcement mechanisms'' of the statutes.\186\ 
Though the Section 1557 rule is informed by the Title VI, Title IX, Age 
Act, and Section 504 implementing regulations, Section 1557 provides an 
independent basis for regulation of discrimination in covered health 
programs and activities that is distinct from Title VI, Title IX, the 
Age Act, and Section 504. Section 1557's nondiscrimination requirements 
do not in any way limit or impact the interpretation of those 
statutes.\187\
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    \185\ See Schmitt v. Kaiser Found. Health Plan of Wash., 965 
F.3d 945, 953 (9th Cir. 2020) (``Section 1557(a) incorporates only 
the prohibited `grounds' and `the mechanisms provided for and 
available under' the four civil rights statutes. A prohibited 
`ground' for discrimination . . . is simply the protected 
classification at issue.'').
    \186\ 42 U.S.C. 18116(a).
    \187\ See id. 18116(b).
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    Section 92.1(b) proposes that the effective date of the Section 
1557 implementing regulation shall be 60 days after the publication of 
a final rule in the Federal Register. This section provides an 
exception to the start date for provisions of this part that require 
changes to health insurance or group health plan benefit design. Such 
provisions will have a delayed implementation date of the first day of 
the first plan year (in the individual market, policy year) beginning 
on or after the year immediately following the effective date of the 
Final Rule in the Federal Register. This delayed implementation will 
allow covered entities to revise their health insurance coverage or 
other health-related coverage to comply with the regulation and to 
avoid administrative challenges associated with applying the Final 
Rule's requirements in the middle of a plan year or policy year. We 
seek

[[Page 47838]]

comments from issuers, employers, and other plan sponsors on how long 
they anticipate it would take to adjust their plan offerings, and from 
Exchanges on how long they would need to implement the proposed 
requirements.

Application (Sec.  92.2)

    Proposed Sec.  92.2 addresses the application of this regulation. 
The Department proposes in Sec.  92.2(a) to apply the rule, except as 
otherwise provided in this part, to: (1) every health program or 
activity, any part of which receives Federal financial assistance, 
directly or indirectly, from the Department; (2) every health program 
or activity administered by the Department; and (3) every program or 
activity administered by a Title I entity.
    Paragraph (a)(1) proposes to make the rule applicable to every 
health program or activity, any part of which receives Federal 
financial assistance, directly or indirectly, from the Department.
    In paragraph (a)(2), we propose to apply the rule to all health 
programs and activities of the Department. This is consistent with the 
2016 Rule, and in contrast to the 2020 Rule, which only applies to 
those programs and activities administered by the Department under 
Title I of the ACA. The statute prohibits discrimination on the 
enumerated bases in ``any program or activity that is administered by 
an Executive Agency or any entity established under this title.'' \188\ 
The operative word, ``or,'' distinguishes programs and activities 
operated by an Executive Agency from those operated by a Title I 
entity. Although the 2020 Rule construes this language to cover only 
programs and activities administered by the Department under Title I of 
the ACA and programs and activities administered by any entity 
established under Title I of the ACA, upon further review the 
Department finds this reading of the statute unpersuasive. We do not 
believe that the best way to resolve any perceived ambiguity is to 
construe the phrase ``established under this title'' as modifying the 
phrase ``administered by an Executive Agency.''
---------------------------------------------------------------------------

    \188\ Id. 18116(a) (emphasis added).
---------------------------------------------------------------------------

    We propose, consistent with the 2016 Rule, to reinstate the word 
``health'' to modify ``programs or activities'' operated by the 
Department. The Department considered applying the rule to all programs 
and activities of the Department; however, we believe this is an 
appropriate limitation for this regulation given the specificity of the 
vast majority of the regulatory provisions to health programs and 
activities. We seek comment on the implications of this scope; the 
implications of applying a Section 1557 implementing regulation broadly 
to all programs and activities of the Department; and, if the 
Department were to do so, if that should be done through a separate 
regulation, similar to the Department's Section 504 implementing 
regulation that applies to programs and activities conducted by the 
Department at 45 CFR part 85.
    Consistent with the 2016 Rule, the Department proposes to limit the 
application of this rulemaking to the health programs and activities of 
only the Department itself and not all Executive Agencies. The 
Department remains committed to working with other Departments that 
administer health programs and activities to support them in their 
efforts to ensure that their programs are nondiscriminatory, because 
Section 1557 applies to programs and activities that are administered 
by all Executive Agencies.\189\ This proposed regulation, however, is 
limited to HHS.
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    \189\ Id.
---------------------------------------------------------------------------

    Proposed paragraph (a)(3) states that the rule applies to every 
program or activity administered by a Title I entity. Title I entities 
include State Exchanges (including those on the Federal platform) and 
federally-facilitated Exchanges, both of which were created under Title 
I of the ACA.\190\ We do not believe the modifier ``health'' is 
necessary when describing covered programs and activities of Title I 
entities because they are, as a whole, health programs or activities 
under the definition of ``health program or activity'' at proposed 
Sec.  92.4.
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    \190\ Section 1311 of the ACA (codified at 42 U.S.C. 18031) 
(establishing grants and requiring those grants to be used by states 
to create ``American Health Benefit Exchanges'').
---------------------------------------------------------------------------

    Proposed paragraph (b) provides that provisions of this part do not 
apply to an employer with regard to its employment practices, including 
the provision of employee health benefits. This is distinct from both 
the 2016 and 2020 Rules, each of which applied to employment in very 
limited circumstances. The 2016 Rule did not apply to hiring, firing, 
promotions, or terms and conditions of employment but did address 
employee health benefit programs at former Sec.  92.208. This provision 
was repealed by the 2020 Rule as ``duplicative of, inconsistent with, 
or confusing in relation to the Department's preexisting regulations,'' 
which instead reverted to enforcing the statutorily referenced 
nondiscrimination statutes through their existing regulations.\191\
---------------------------------------------------------------------------

    \191\ 85 FR 37160, 37169 (June 19, 2020).
---------------------------------------------------------------------------

    The Department has considered this issue, in consultation with 
Federal agencies primarily charged with enforcing existing employment 
discrimination laws, and is proposing that this part not apply to 
employment. OCR recognizes that over 55 percent of the U.S. population 
receives health care benefits through an employer.\192\ However, based 
on enforcement experience under the 2016 and 2020 Rules, we believe 
that the proposed approach will minimize confusion among individuals 
seeking relief and will decrease the likelihood that individuals 
seeking relief under Federal Equal Employment Opportunity laws will 
miss strict time limits for filing complaints to challenge 
discrimination under those laws. The Department is proposing this 
language to promote clarity regarding the filing and processing of 
discrimination complaints. The Department proposes that employment 
discrimination complaints alleging violations of similar protections 
against discrimination to those that are covered under Section 1557 be 
handled by other Federal agencies under the statutes they enforce, and 
not by the Department. The Department would maintain jurisdiction over 
complaints alleging discrimination in covered health insurance or other 
health-related coverage; however, should the Department receive a 
complaint under Section 1557 alleging discrimination by an employer 
(such as a claim involving a Federal Employees Health Benefits plan), 
such a complaint will be referred to the appropriate Federal agency if 
it is determined that another agency (e.g., Office of Personnel 
Management (OPM), Equal Employment Opportunity Commission (EEOC), or 
DOJ) may have jurisdiction under the statutes it enforces.
---------------------------------------------------------------------------

    \192\ Katherine Keisler-Starkey & Lisa N. Bunch, U.S. Dep't of 
Commerce, U.S. Census Bureau, Health Insurance Coverage in the 
United States: 2019, p. 4 (2020), https://www.census.gov/content/dam/Census/library/publications/2020/demo/p60-271.pdf.
---------------------------------------------------------------------------

    Proposed paragraph (c) provides that if any provision of this part 
is held to be invalid or unenforceable by its terms, or as applied to 
any person or circumstance, it shall be severable from this part and 
not affect the remainder thereof or the application of the provision to 
other persons not similarly situated or to other, dissimilar 
circumstances.
    We seek comment on the effects of the proposed scope of application 
of the regulation, including the application to

[[Page 47839]]

programs and activities of the Department and other Executive Agencies; 
application of this part to recipients of Federal financial assistance 
from Executive Agencies other than the Department; and the application 
to employment.

Treatment of Title IX Exceptions

    Section 1557 provides that ``an individual shall not, on the ground 
prohibited under'' Title VI, Title IX, the Age Act, and Section 504, 
``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.'' \193\ The 
statute further provides that ``[t]he enforcement mechanisms provided 
for and available under'' Title VI, Title IX, the Age Act, and Section 
504 ``shall apply for purposes of violations of this subsection.'' 
\194\ Section 1557 thus explicitly incorporates from those four 
statutes the grounds of discrimination that are prohibited and the 
enforcement mechanisms of the referenced statutes (Title VI, Title IX, 
the Age Act, and Section 504). Under the most natural understanding of 
Section 1557's text, as well as the statute's structure and purpose, 
the statutory term ``ground prohibited'' is best understood as 
incorporating the bases of the discrimination prohibitions in the 
referenced statutes (race, color, national origin, sex, age, and 
disability).
---------------------------------------------------------------------------

    \193\ 42 U.S.C. 18116(a).
    \194\ Id.
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    As discussed further below, the Department also believes that in 
order to construe particular terms in (or incorporated by) Section 
1557, such as the meaning of ``sex'' or ``disability''; what it means 
to be ``subjected to discrimination'' on one of the specified grounds; 
the scope of ``program or activity''; and what counts as ``Federal 
financial assistance,'' it is reasonable and appropriate to look to how 
Congress, the agencies, and the courts have construed those terms under 
Title VI, Title IX, the Age Act, and Section 504. There is no similar 
basis, however, for concluding that Congress incorporated into Section 
1557 any of the exceptions that Congress added to Title IX--the only 
one of the four statutes referenced by Section 1557 that contains such 
exceptions, and also the only statute with jurisdiction that is limited 
to a certain type of program or activity (i.e., education programs or 
activities). At the very least, Section 1557 does not unambiguously 
require HHS to incorporate any of the Title IX exceptions into its 
regulatory scheme.\195\
---------------------------------------------------------------------------

    \195\ To the degree that there is any statutory ambiguity, the 
Department has discretion as to whether and how to incorporate other 
aspects of the referenced statutes. See Chevron, U.S.A., Inc. v. 
Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984) (courts should 
give ``considerable weight to an executive department's construction 
of a statutory scheme it is entrusted to administer, and the 
principle of deference to administrative interpretations, `has been 
consistently followed whenever a decision as to the meaning or reach 
of a statute has involved reconciling conflicting policies, and a 
full understanding of the force of the statutory policy in the given 
situation has depended upon more than ordinary knowledge respecting 
the matters subjected to agency regulations''').
---------------------------------------------------------------------------

    Section 1681(a) of Title IX states the statute's basic prohibition 
on discrimination on the basis of sex, and then enumerates several 
circumstances in which that prohibition does not apply, which it 
denominates as ``exceptions'' from the basic rule of section 1681(a). 
The prohibition on sex-based discrimination does ``not apply'' at all, 
for example, ``to an educational institution whose primary purpose is 
the training of individuals for the military services of the United 
States, or the merchant marine''; \196\ nor does it apply to any 
program or activity of the American Legion undertaken in connection 
with the organization or operation of any Boys State conference, Boys 
Nation conference, Girls State conference, or Girls Nation 
conference.\197\ Title IX includes an exception for admissions 
decisions of educational institutions other than institutions of 
vocational education, professional education, graduate higher 
education, and public undergraduate institutions,\198\ and yet another 
exception for the membership practices of certain tax-exempt social 
fraternities and sororities, the YMCA and YWCA, the Girl Scouts, the 
Boy Scouts, and voluntary youth service organizations whose membership 
has ``traditionally been limited to persons of one sex and principally 
to persons of less than nineteen years of age.'' \199\ Title IX also 
contains exceptions that permit educational institutions to authorize 
father-son or mother-daughter activities,\200\ and to award 
scholarships based upon the results of sex-specific beauty 
pageants.\201\ Section 1681(a)(3) contains another exception for an 
educational institution controlled by a religious organization, which 
is permitted to engage in otherwise prohibited sex discrimination in 
particular circumstances--namely, where ``the application of [Title 
IX's nondiscrimination mandate] would not be consistent with the 
religious tenets of such organization.'' \202\
---------------------------------------------------------------------------

    \196\ 20 U.S.C. 1681(a)(4).
    \197\ Id. 1681(a)(7).
    \198\ Id. 1681(a)(1).
    \199\ Id. 1681(a).
    \200\ Id. 1681(a)(8).
    \201\ Id. 1681(a)(9).
    \202\ The section 1681(a)(3) exception applies only to certain 
religiously affiliated educational institutions. The Civil Rights 
Restoration Act of 1987, however, contains a proviso that exempts 
application of Title IX to ``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,'' creating a parallel 
exception to that contained in section 1681(a)(3).
---------------------------------------------------------------------------

    The 2016 Rule did not incorporate these Title IX exceptions for 
purposes of construing Section 1557. The treatment under the 2020 Rule 
is not as clear. Section 92.6(b) of the 2020 Rule states that 
``[i]nsofar as the application of any requirement under this part would 
violate, depart from, or contradict definitions, exemptions, 
affirmative rights, or protections provided by'' the four referenced 
nondiscrimination statutes (and several others that are listed), ``such 
application shall not be imposed or required.'' (Emphasis added.) The 
preamble to the 2020 Rule asserted that because Section 1557 
``incorporates the statutory scope of Title IX, . . . it is appropriate 
for this rule to incorporate the Title IX statutory language concerning 
religious institutions . . . '' \203\ Indeed, the preamble went so far 
as to say that ``this final rule amends the Department's Title IX 
regulation to explicitly incorporate relevant statutory exemptions from 
Title IX, including . . . the religious exemption.'' \204\ The 
regulatory text of the 2020 Rule itself, however, does not expressly 
call for incorporation of the religious exemption nor repeat the 
specific language of that Title IX provision.\205\
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    \203\ 85 FR 37160, 37207-08 (June 19, 2020) (emphasis added).
    \204\ 85 FR 37162.
    \205\ Following issuance of the 2020 Rule, a consortium of 
plaintiffs filed a lawsuit against the Department in Federal 
district court, seeking to enjoin the Department from incorporating 
the Title IX religious exemption. Compl., Whitman-Walker Clinic v. 
U.S. Dep't of Health & Human Servs., No. 1:20-cv-01630 (D.D.C. June 
22, 2020) [hereinafter Whitman-Walker Complaint]; see also Compl. 
BAGLY v. U.S. Dep't of Health & Human Servs., No. 20-11297, (D. 
Mass. July 9, 2020); Compl. N.Y. v. U.S. Dep't of Health & Human 
Servs., No. 1:20-cv-05583 (S.D.N.Y. July 20, 2020). A little more 
than two weeks after the 2020 Rule went into effect, the court in 
Whitman-Walker Clinic, Inc., et al. v. U.S. Dep't of Health & Human 
Servs. preliminarily enjoined the Department ``from enforcing its 
incorporation of the religious exemption contained in Title IX.'' 
Whitman-Walker Clinic v. U.S. Dep't of Health & Human Servs., 485 F. 
Supp. 3d 1, 37 (D.D.C. 2020). The court held that the Department's 
apparent inclusion of Title IX's religious exemption in the 2020 
Rule violated the APA because the Department failed to consider 
``the potential negative consequences that importing a blanket 
religious exemption into Section 1557 might have for access to 
health care.'' Id. (citing Mfrs. Ass'n v. State Farm Mut. Auto Ins., 
463 U.S. 29, 42 (1983) (agency must examine relevant date and 
articulate a satisfactory explanation for its action including a 
rational connection between the facts found and the choice made)). 
The preliminary injunction issued by the court in Whitman-Walker 
remains in effect.

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

[[Page 47840]]

    This NPRM proposes not to import any of the Title IX exceptions 
into the Section 1557 regulation because the statutory language of 
Section 1557 is best interpreted to not authorize, and at the very 
least not command, the Secretary to promulgate such an extension of the 
Title IX exceptions.
    The Department's analysis begins with the relevant statutory text. 
Section 1557 prohibits discrimination ``on the ground[s] prohibited 
under'' Title IX and the other referenced statutes.\206\ The district 
court in Franciscan Alliance read the term ``ground'' to necessarily 
incorporate not only the prohibited basis for discrimination--i.e., 
sex--but also any exceptions set forth in Title IX.\207\ The Department 
believes that, as a textual matter, the more natural understanding of 
``ground prohibited'' is that it refers simply to the basis on which 
discrimination is prohibited. Further, subsection (b) of Section 1557 
refers to ``discrimination on any basis described in subsection (a),'' 
which suggests that ``ground'' in subsection (a) means the ``basis'' 
for discrimination, i.e., race, color, national origin, sex, age, and 
disability.\208\
---------------------------------------------------------------------------

    \206\ 42 U.S.C. 18116(a).
    \207\ Franciscan All., Inc. v. Burwell, 227 F. Supp. 3d 660, 
690-91 (N.D. Tex. 2016).
    \208\ 42 U.S.C. 18116(b) (emphasis added).
---------------------------------------------------------------------------

    Recent Supreme Court opinions support the Department's reading. In 
an April 2022 decision, the Court used the term ``grounds'' when 
discussing prohibited bases for discrimination in several 
antidiscrimination statutes, including Section 1557.\209\ Additionally, 
in the Bostock decision, the Court also used the term ``grounds'' in 
interpreting Title VII, while also referring separately to Title VII's 
``express statutory exception for religious organizations.'' \210\
---------------------------------------------------------------------------

    \209\ Cummings v. Premier Rehab Keller, P.L.L.C., 142 S. Ct. 
1562, 1569 (2022) (``Congress has enacted four statutes prohibiting 
recipients of Federal financial assistance from discriminating based 
on certain protected grounds.'').
    \210\ Bostock v. Clayton Cty., 140 S. Ct. 1731, 1742, 1754 
(2020).
---------------------------------------------------------------------------

    As a matter of ordinary speech, it would be uncommon to refer to a 
provision ``excepting'' particular entities from a statutory 
prohibition on discrimination as part of the ``ground prohibited'' by 
the statute from which they are excepted. The preamble to the 2020 Rule 
assumed that Section 1557 ``incorporates the statutory scope of Title 
IX''--which it understood to include Title IX's exceptions.\211\ But 
nowhere does Section 1557 state that it incorporates the full ``scope'' 
of those statutes. The better reading of the text of Section 1557, 
then, is that it expressly incorporates the ``grounds'' and 
``enforcement mechanisms'' of the four antidiscrimination statutes, but 
not their scope. Instead, the text of Section 1557 provides its own 
scope of application--to ``any health program or activity, any part of 
which is receiving Federal financial assistance, including credits, 
subsidies, or contracts of insurance, or under any program or activity 
that is administered by an Executive Agency or any entity established 
under'' Title I of the ACA.\212\ Therefore, the best reading of Section 
1557 is that it does not incorporate Title IX's religious exception or 
any of the other Title IX exceptions.
---------------------------------------------------------------------------

    \211\ 85 FR at 37208.
    \212\ 42 U.S.C. 18116(a).
---------------------------------------------------------------------------

    Section 1557's structure confirms that textual understanding. The 
statute explicitly incorporates ``[t]he enforcement mechanisms provided 
for and available under'' the referenced statutes.\213\ That provision 
demonstrates that when Congress wanted to incorporate aspects of the 
referenced statutes other than the ``grounds'' of prohibited 
discrimination, it did so expressly. There is, by contrast, no such 
express incorporation of the Title IX exceptions. To the contrary, the 
very first words of Section 1557 are that ``[e]xcept as otherwise 
provided for in this title (or an amendment made by this title), an 
individual shall not, on the ground prohibited under [the four 
referenced statutes], 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 . . .'' \214\ Congress, in other words, specifically 
signaled that the only ``except[ions]'' to Section 1557's prohibition 
would be those ``provided for'' or ``made by'' Title I of the ACA, 
which does not encompass Title IX of the Education Amendments of 1972.
---------------------------------------------------------------------------

    \213\ Id. Sec.  18116.
    \214\ Id. 18116(a) (emphasis added).
---------------------------------------------------------------------------

    Furthermore, Section 1557's role as a health care statute further 
supports the Department's reading of the text and understanding of 
Congress' intent. The Title IX exceptions are specifically concerned 
with educational institutions and other recipients of Federal funds 
that operate an education program or activity. The apparent reasons for 
the exceptions in the education setting would, at least in many cases, 
be inappropriate or nonsensical in the context of health programs and 
activities. For example, Title IX exceptions related to the membership 
practices of social fraternities, sororities, YWCA, YMCA, Girls Scouts, 
Boys Scouts, and voluntary youth service organizations; father-son and 
mother-daughter activities; and beauty pageant-based scholarships are 
ill-suited for application to health programs and activities.
    Moreover, the application of the Title IX exception for entities 
controlled by religious organizations, in particular, could raise 
distinctive concerns in the health care context that are not typically 
present in education programs and activities. Health care settings 
differ significantly from educational settings with respect to both the 
ability of affected parties to choose or avoid a certain religiously 
affiliated health care institution and the urgency of the need for 
services provided by the covered entities.\215\ For example, access to 
health care settings raises considerations of choice and notice to 
affected parties that are largely absent in the educational context. 
Whereas students and families typically make a choice to attend 
religious educational institutions, patients seeking health care are 
much more likely to be driven by considerations of availability, 
convenience, urgency, geography, cost, insurance network restrictions, 
and other factors unrelated to the question of whether the health care 
provider is controlled by or affiliated with a religious organization. 
There are an increasing number of communities in the United States with 
limited options to access health care from non-religiously affiliated 
health care providers.\216\ As a practical matter, then, many patients 
and their families may have little or no choice about where to seek 
care, particularly in exigent circumstances, or in cases where the 
quality or range of care may vary dramatically among providers. 
Moreover, health care consumers are not always aware that the health 
care entities from which they seek care may

[[Page 47841]]

be limited in the care they provide.\217\ Incorporation of Title IX's 
religious exception would therefore seriously compromise Congress's 
principal objective in the ACA of increasing access to health care.
---------------------------------------------------------------------------

    \215\ 81 FR 31375, 31380 (May 18, 2016).
    \216\ See, e.g., Maryam Guiahi et al., Patient Views on 
Religious Institutional Health Care, 2 JAMA Network Open, Dec. 27, 
2019, at p. 2, https://pubmed.ncbi.nlm.nih.gov/31880794/ (discussing 
growing religious ownership of health care entities in the context 
of whether U.S. adults consider religious affiliation when selecting 
health care facilities); Michael Booth, SCL Health to Merge with 
Intermountain Health, Creating Not-For-Profit Hospital Giant in 
West, The Colorado Sun (Sept. 16, 2021), https://coloradosun.com/2021/09/16/hospital-merger-scl-health-colorado/.
    \217\ See, e.g., Coleman Drake et al., Market Share of US 
Catholic Hospitals and Associated Geographic Network Access to 
Reproductive Health Services, Jama Network Open, Jan. 29, 2020, 
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759762 
(research study examining the impact and growth of Catholic health 
care entities on the provision of reproductive health care in the 
United States); Harris Meyer, Most Catholic Hospitals Don't Disclose 
Religious Care Restrictions, Modern Healthcare, Mar. 15, 2019, 
https://www.modernhealthcare.com/operations/most-catholic-hospitals-dont-disclose-religious-care-restrictions.
---------------------------------------------------------------------------

    While not incorporating the Title IX religious exception, the 
Department is fully committed to respecting conscience and religious 
freedom laws when applying this rule, including an organization's 
assertion that the provisions of this rule conflict with their rights 
under Federal conscience and religious freedom laws as addressed in 
proposed Sec.  92.302.
    The application of these statutes, all of which Congress enacted 
after it enacted Title IX, protects important religious liberty 
interests and conflicts of conscience, even without the incorporation 
of the Title IX religious exception into Section 1557. Under RFRA, 
exemptions from any of the antidiscrimination requirements of Section 
1557 would depend in part on the ramifications of applying such 
exemptions. For example, even if the rule substantially burdened 
religious practices, a religious exemption would not be required if 
that burden was the result of the government's advancement of a 
compelling interest by means that were least restrictive of religious 
exercise in particular contexts. The U.S. Supreme Court has made it 
clear that a fact-sensitive, case-by-case analysis of such burdens and 
interests is needed under RFRA, something the Title IX exception does 
not allow.\218\ The Department will apply RFRA in this manner.
---------------------------------------------------------------------------

    \218\ See, e.g., Gonzales v. O Centro Esp[iacute]rita 
Beneficente Uni[atilde]o do Vegetal, 546 U.S. 418, 430-31 (2006) 
(when applying RFRA, courts look ``beyond broadly formulated 
interests justifying the general applicability of government 
mandates and scrutinized the asserted harm of granting specific 
exemptions to particular religious claimants''); cf. Ramirez v. 
Collier, 142 S. Ct. 1264, 1281 (2022) (holding that the Religious 
Land Use and Institutionalized Persons Act, which applies RFRA's 
test for religious exemptions in the prison context, ``requires that 
courts take cases one at a time, considering only `the particular 
claimant whose sincere exercise of religion is being substantially 
burdened''') (quoting Holt v. Hobbs, 574 U.S. 352, 363 (2015)).
---------------------------------------------------------------------------

    Applying the existing Federal conscience and religious freedom laws 
will allow the Department to address the interests in providing 
nondiscriminatory health care and religious or conscience commitments 
by applying the legal standards applicable to those conscience and 
religious freedom laws. It was reasonable for Congress to rely upon 
existing conscience and religious freedom laws to protect religious 
exercise and respect conscience in appropriate cases, rather than to 
import the Title IX religious exception \219\ into Section 1557.
---------------------------------------------------------------------------

    \219\ A religiously controlled covered entity that operates an 
education program or activity that is entitled to a religious 
exemption under Title IX would follow the Department's Title IX 
regulation at 45 CFR 86.12.
---------------------------------------------------------------------------

    We seek comment on the approach proposed in this NPRM and 
particularly invite comments from covered entities controlled by or 
affiliated with religious organizations; providers employed by such 
entities; and people who receive health care from religiously 
affiliated medical providers and entities.

Relationship to Other Laws (Sec.  92.3)

    Proposed Sec.  92.3 explains the relationship of the proposed 
regulation to existing laws. Paragraph (a) provides that Section 1557 
is not intended to apply lesser standards for the protection of 
individuals from discrimination than the standards under Title VI, 
Title IX, Section 504, the Age Act, or the regulations issued pursuant 
to those laws.
    Consistent with the statute, paragraph (b)(1) states that nothing 
in this part shall be interpreted to invalidate or limit the existing 
rights, remedies, procedures, or legal standards available to 
individuals aggrieved under the Federal civil rights laws cited in 42 
U.S.C. 18116(b) (Title VI, Title VII, Title IX, Section 504, and the 
Age Act).
    We note here that Title II of the Americans with Disabilities Act 
\220\ (ADA) prohibits discrimination on the basis of disability by 
public entities (i.e., State and local governments and their agencies) 
and is modeled on Section 504.\221\ Title II of the ADA and Section 504 
are generally understood to impose substantially the same requirements, 
given that Congress enacted the ADA to extend Section 504's existing 
protections beyond Executive Agencies and recipients of Federal 
funds,\222\ and the Congressional directive that the ADA be construed 
to grant at least as much protection as provided by Section 504 and the 
regulation implementing Section 504.\223\ Following the passage of the 
ADA, the Rehabilitation Act Amendments of 1992 revised the 
Rehabilitation Act's findings, purpose, and policy provisions to 
incorporate language acknowledging the discriminatory barriers faced by 
individuals with disabilities, and to recognize that individuals with 
disabilities have the right to ``enjoy full inclusion and integration 
in the economic, political, social, cultural and educational mainstream 
of American society.'' \224\ The Senate Report concerning the 
Rehabilitation Act Amendments of 1992 states that the purpose and 
policy statement is ``a reaffirmation of the precepts of the Americans 
with Disabilities Act'' and that these principles are intended to guide 
the Rehabilitation Act's policies, practices, and procedures.\225\
---------------------------------------------------------------------------

    \220\ Public Law 101-336, 104 Stat. 327 (1990) (codified as 
amended at 42 U.S.C. 12101, et seq.).
    \221\ 42 U.S.C. 12132 (``[N]o qualified individual with a 
disability shall, by reason of such disability, be excluded from 
participation in or be denied the benefits of services, programs, or 
activities of a public entity, or be subjected to discrimination by 
any such entity.'').
    \222\ See Berardelli v. Allied Servs. Inst. of Rehab. Med., 900 
F.3d 104, 115 (3d Cir. 2018).
    \223\ See, e.g., 42 U.S.C. 12201(a).
    \224\ 29 U.S.C. 701(a)(3), as amended.
    \225\ S. Rep. 102-357, at 14 (Aug. 3, 1992); H.R. Rep. 102-822, 
at 81 (Aug. 10, 1992).
---------------------------------------------------------------------------

    Accordingly, a number of the changes that the Department is 
proposing for specific disability-related provisions in the Section 
1557 regulation, which encompasses Section 504's ground for 
discrimination, conform to DOJ's implementing regulation for Title II 
of the ADA, many of which were updated in 2010. Where the Department 
has made changes to its Section 1557 regulation to correspond to 
provisions in DOJ's Title II regulation, the Department encourages 
individuals to look to the corresponding Title II guidance and section-
by-section analysis for guidance on how to interpret these 
provisions.\226\
---------------------------------------------------------------------------

    \226\ See 28 CFR pt. 35, app. A, B, C.
---------------------------------------------------------------------------

    The Department also notes that there may be overlap among different 
Federal civil rights statutes, and that certain Section 504 
requirements and terminology may be specific to the programs and 
activities that are funded or conducted by the relevant Federal agency. 
For example, if a covered entity is a recipient of Federal financial 
assistance from the Department of Housing and Urban Development (HUD), 
HUD's Section 504 regulation, which contains distinct requirements and 
terminology related to housing, would also apply.
    Proposed paragraph (b)(2) provides that nothing in Section 1557 
shall be interpreted to invalidate or limit the existing rights, 
remedies, procedures, or legal standards available to individuals

[[Page 47842]]

asserting rights under Federal conscience or religious freedom laws. 
These would include statutory protections under RFRA and the Coats-
Snowe Amendment,\227\ the Church Amendments,\228\ section 1303 of the 
ACA,\229\ section 1553 of the ACA,\230\ and the Weldon Amendment.\231\
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    \227\ 42 U.S.C. 238n.
    \228\ Id. 300a-7.
    \229\ Id. 18023(b)(2)(A).
    \230\ Id. 18113.
    \231\ Consolidated Appropriations Act, 2022, Public Law 117-103, 
div. H, title V General Provisions, Sec.  507(d)(1) (Mar. 15, 2022).
---------------------------------------------------------------------------

    Under the 2016 Rule, former Sec.  92.2(b)(2) provided that if an 
application of Section 1557 requirements violated applicable Federal 
statutory protections for conscience and religious exercise, 
application of Section 1557 was not required.\232\ The 2020 Rule, at 
Sec.  92.6(b), provides that Section 1557 will not apply if such 
application would ``violate, depart from, or contradict definitions, 
exemptions, affirmative rights, or protections'' of the Coats-Snowe 
Amendment, Church Amendments, RFRA, Section 1553 of the ACA, Section 
1303 of the ACA, Weldon Amendment, or ``any related, successor, or 
similar Federal laws or regulations.'' \233\ The Department has 
considered the current regulatory language and has determined that the 
2020 Rule also fails to provide sufficient information to covered 
entities and beneficiaries regarding how OCR will approach any apparent 
interaction between Section 1557 requirements and the enumerated 
protections. Further, the 2020 Rule preamble and Regulatory Impact 
Analysis (RIA) failed to consider potential harms to third parties that 
may result from granting a religious exemption in the health care 
context--a consideration that can be relevant to the RFRA analysis in a 
particular case.\234\ The Department acknowledges and respects laws 
protecting conscience and religious exercise. The Department believes 
the approach in this proposed rule will ensure that all constitutional 
and statutory rights are protected and seeks comment on this approach. 
We further address exemptions under Federal conscience and religious 
freedom laws at proposed Sec.  92.302.
---------------------------------------------------------------------------

    \232\ 81 FR 31375, 31381 (May 18, 2016).
    \233\ 45 CFR 92.6(b).
    \234\ See, e.g., Whitman-Walker Clinic v. U.S. Dep't of Health & 
Human Servs., 845 F. Supp. 3d 1, 45-46 (D.D.C. 2020).
---------------------------------------------------------------------------

Definitions (Sec.  92.4)

    Proposed Sec.  92.4 contains proposed definitions, which is the 
same approach taken in the 2016 Rule at former Sec.  92.4. The 2020 
Rule does not include a specific definition section, an approach that 
contributes to uncertainty. We reintroduce definitions to help 
reinstate clarity. For ease of organization, definitions are discussed 
below by topic area, and definitions of particular note are set out in 
additional detail.
    We propose to define a range of terms related to disability 
discrimination, including: auxiliary aids and services; disability; 
qualified individual with a disability; qualified interpreter for an 
individual with a disability; and qualified reader. These definitions 
appeared in the 2016 Rule and have not been changed substantively, with 
the exception of the addition of the term ``qualified reader,'' which 
incorporates the definition of ``qualified reader'' from the ADA Title 
II regulation \235\ to provide clarity to both covered entities and 
protected individuals about the necessary qualifications of a reader 
when required under this regulation. Any other differences between the 
definitions proposed herein and the 2016 Rule were made to update 
appropriate citations.
---------------------------------------------------------------------------

    \235\ 28 CFR 35.104.
---------------------------------------------------------------------------

    We also propose to define a range of terms related to language 
access, including limited English proficient individual; language 
assistance services; qualified bilingual/multilingual staff; qualified 
interpreter for a limited English proficient individual; and qualified 
translator. These definitions appeared in the 2016 Rule and have not 
been changed substantively. Terminology has been revised to read 
``limited English proficient individual,'' rather than ``individual 
with limited English proficiency,'' as ``limited English proficient 
individual'' reflects widely used terminology. The Department also 
proposes to provide more detail in the definition of ``limited English 
proficient individual'' to explain that a limited English proficient 
individual may be competent in English for certain types of 
communication (e.g., speaking or understanding), but still be LEP for 
other purposes (e.g., reading or writing). This language will assist 
covered entities in understanding that a person who has proficiency in 
English in one context (e.g., speaking) may still require assistance in 
another context (e.g., receiving translated documents). The Department 
welcomes comment on this change in terminology.
    We also propose to define terms related to covered entities and 
other entities addressed in the rule, including applicant; companion; 
covered entity; Department; Director; Exchange; Federally-facilitated 
Exchange; OCR; recipient; State Exchange; and Title I Entity. These 
definitions were included in the 2016 Rule and have not been changed 
substantively, though we have replaced the term ``Marketplace'' with 
``Exchange'' to reflect the terminology used in Departmental 
regulations defining the term.\236\ The terms ``age'' and ``national 
origin'' are also defined, with the same definitions as provided in the 
2016 Rule.
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    \236\ 45 CFR 155.20 (defining ``Exchange'' and ``Federally-
facilitated Exchange''); Sec.  155.100 (providing for establishment 
of an Exchange by a State).
---------------------------------------------------------------------------

    Particular definitions of note are included below.
    Federal financial assistance. We propose to include the definition 
of Federal financial assistance found in former Sec.  92.4 of the 2016 
Rule, with slight modifications. The 2020 Rule does not include a 
definition of this term.
    We propose the definition of ``Federal financial assistance'' to 
include grants, loans, and other types of assistance from the Federal 
Government, in accordance with the definition of the term in the 
Section 504 and the Age Act implementing regulations at 45 CFR 84.3(h) 
and 91.4, respectively. We also propose to specifically include 
credits, subsidies, and contracts of insurance, in accordance with the 
statutory language of Section 1557. Examples of HHS programs that 
provide Federal financial assistance subject to this part include but 
are not limited to Medicaid and CHIP, Medicare Part A, Medicare Part B 
(as proposed in this rule), Medicare Part C (Medicare Advantage), 
Medicare Part D (drug coverage), and HHS grant programs.
    As discussed previously, similar to the 2016 and 2020 Rules, this 
proposed rule applies only to Federal financial assistance from HHS and 
does not apply to health programs or activities receiving Federal 
financial assistance from other Federal agencies.\237\ While the 
Section 1557 statute applies to all Executive Agencies, the Department 
continues to believe that it is appropriate to limit this proposed rule 
to health programs or activities that receive Federal funding from the 
Department, which is within the Department's area of expertise. We 
encourage other Federal agencies to use this proposed rule as a 
template for developing their own Section 1557 regulations and policies 
applicable to their federally assisted health programs or activities.
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    \237\ 81 FR 31375, 31379 (May 18, 2016); 85 FR 37160, 37170 
(June 19, 2020).
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    We propose to include a clause to clarify the Federal financial 
assistance

[[Page 47843]]

includes Federal financial assistance that the Department plays a role 
in providing or administering. This includes advance payments of the 
premium tax credit and cost-sharing reduction payments under Title I of 
the ACA, as well as payments, subsidies, or other funds extended by the 
Department. This is similar to, but differs slightly from, the 2016 
Rule by clarifying that the Federal financial assistance that the 
Department plays a role in providing or administering includes the 
``advance payments of the premium tax credit and cost-sharing reduction 
payments,'' which are the relevant credit and subsidy payments under 
Title I of the ACA that the Department plays a role in providing or 
administering. The language in this provision was informed by the 
definition of ``Federal financial assistance'' in the regulation 
implementing Title IX at 45 CFR 86.2(g). That Title IX regulatory 
provision clarifies that Federal financial assistance includes wages, 
loans, grants, scholarships, and other monies that are given to any 
entity for payment to or on behalf of students who are admitted to that 
entity or that are given directly to these students for payment to that 
entity.\238\
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    \238\ 45 CFR 86.2(g)(1)(ii).
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    In the health care context, Federal funds are provided on behalf of 
eligible individuals for advance payments of the premium tax credit and 
cost-sharing reductions (also referred to as cost-sharing subsidies) to 
ensure the affordability of health insurance coverage purchased through 
the Health Insurance Exchanges. As in the 2016 Rule, we have added 
language to this proposed definition stating that such funds, as well 
as payments, subsidies, or other funds extended by the Department, are 
Federal financial assistance covered by the Rule when extended to the 
entity providing the health insurance coverage or services, whether 
they are paid directly by the Federal Government to that entity or to 
the individual for payment to the entity providing health insurance 
coverage or services. Thus, an issuer participating in any Health 
Insurance Exchange is receiving Federal financial assistance when 
advance payments of the premium tax credit or cost-sharing subsidies 
are provided on behalf of any of the issuer's enrollees. A health 
services provider that contracts with such an issuer does not become a 
recipient of Federal financial assistance by virtue of the contract but 
would be a recipient if the provider otherwise receives Federal 
financial assistance, such as through participation in Medicare or 
Medicaid.
    The 2020 Rule did not include language regarding Federal financial 
assistance that the Department plays a role in providing or 
administering. The Department asserted in the preamble of the 2020 Rule 
that the 2016 definition was overbroad. This interpretation fails to 
consider the statutory language of Section 1557, which specifically 
includes ``credits'' and ``subsidies'' as Federal financial assistance, 
in conjunction with the entirety of Title I of the ACA, which 
specifically grants the Secretary clear authority over the programs for 
which the Department plays a role in providing or administering Federal 
financial assistance. These Title I programs include the advance 
payments of the premium tax credit and cost-sharing reductions,\239\ as 
well as pass-through funding available to states through section 1332 
waivers.\240\
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    \239\ Section 1412 of the ACA, codified at 42 U.S.C. 18082.
    \240\ Section 1332(a)(3) of the ACA, codified at 42 U.S.C. 
18052(a)(3).
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    The Department plays a role in providing or administering advance 
payments of the premium tax credit and cost-sharing reductions as set 
forth in Title I of the ACA, which specifies that the Secretary of HHS, 
``in consultation with the Secretary of the Treasury, shall establish a 
program'' for advance payments of the premium tax credit and cost-
sharing reductions.\241\ HHS advises the Department of the Treasury of 
the amounts of advance payments of the premium tax credit and cost-
sharing reductions and works with Department of the Treasury to make 
payments to issuers.\242\
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    \241\ Section 1412 (a)-(c) of the ACA, codified at 42 U.S.C. 
18082(a)-(c).
    \242\ Id.
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    The Department notes that it is not currently making cost-sharing 
reduction payments to issuers. On October 11, 2017, the Attorney 
General issued a legal opinion that HHS did not have a valid 
appropriation with which to make cost-sharing reduction payments to 
issuers.\243\ As a result, the cost-sharing reduction payments ceased 
as of October 12, 2017.\244\ If issuers receive cost-sharing reduction 
payments in the future from the Department, such payments would be 
considered Federal financial assistance under this proposed rule 
similar to the advance payments of the premium tax credit.
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    \243\ Memorandum from Eric Hargan, Acting Sec'y, Dep't of Health 
& Human Servs., to Seema Verma, Admin'r, Ctrs. for Medicare & 
Medicaid Servs. (enclosing Attorney General Jeff Sessions' legal 
opinion, dated October 11, 2017, regarding cost-sharing reduction 
payments) (Oct. 12, 2017), https://www.hhs.gov/sites/default/files/csr-payment-memo.pdf.
    \244\ Id.
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    Similarly, the Department plays a role in providing or 
administering pass-through funding available to states through section 
1332 waivers.\245\ Section 1332 of the ACA provides that states may 
apply to the Department of Health and Human Services and the Department 
of the Treasury for waivers of certain ACA requirements in the 
individual and small group markets if the waiver satisfies certain 
statutory requirements.\246\ Section 1332(a)(3) of the ACA directs the 
Department of Health and Human Services and the Department of the 
Treasury to pay pass-through funding to the state for the purpose of 
implementing the state section 1332 waiver plan and outlines 
accompanying requirements for making the pass-through funding 
determination.\247\ The amount of Federal pass-through funding is equal 
to the amount, determined annually by the Department of Health and 
Human Services and the Department of the Treasury, of the premium tax 
credit under section 36B of the Internal Revenue Code, the small 
business tax credit under section 45R of the Internal Revenue Code, or 
cost-sharing reductions under ACA Title I, part I of subtitle E, that 
individuals and small employers in the state would otherwise be 
eligible for had the state not received approval for its section 1332 
waiver. This calculation includes any amount not paid due to an 
individual or small employer not qualifying for the premium tax credit, 
small business tax credit, or cost-sharing reductions or qualifying for 
a reduced level of such financial assistance.\248\
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    \245\ Section 1332(a)(3) of the ACA, codified at 42 U.S.C. 
18052(a)(3).
    \246\ Section 1332(a) of the ACA, codified at 42 U.S.C. 
18052(a). States with approved waivers have specific terms and 
conditions (STCs) that the state must also comply with all 
applicable Federal statutes relating to nondiscrimination, including 
Section 1557. See e.g., Ctrs. for Medicare & Medicaid Servs., 
approval of Colorado's extension application for a section 1332 
State Innovation Waiver, STC 4 (Aug. 13, 2021), https://www.cms.gov/files/document/1332-co-extension-approval-letter-stcs.pdf.
    \247\ See Section 1332(a)(3) of the ACA, codified at 42 U.S.C. 
18052(a)(3), and implementing regulations at 31 CFR 33.122, 45 CFR 
155.1322.
    \248\ 31 CFR 33.122; 45 CFR 155.1322; 86 FR 53412 (Sept. 27, 
2021).
---------------------------------------------------------------------------

    As with the advance payments of the premium tax credit, HHS plays a 
role in providing the section 1332 pass-through funding by working with 
the Department of the Treasury in calculating the pass-through funding 
amount and administering the pass-

[[Page 47844]]

through funds to the state.\249\ We also note that any entity receiving 
section 1332 pass-through funds from the state would also be a 
recipient of Federal financial assistance from HHS under Section 1557.
---------------------------------------------------------------------------

    \249\ 42 U.S.C. 18052(a)(3).
---------------------------------------------------------------------------

    In conclusion, in all of these programs, the ACA establishes that 
the Secretary of HHS is involved in calculating the amounts of Federal 
financial assistance and sets forth the Secretary's role in 
administering the programs. For these reasons, we are reinstituting the 
provision that Federal financial assistance for purposes of HHS' 
jurisdiction under this part includes that Federal financial assistance 
which the Department plays a role in providing or administering.
    Health program or activity. The Department proposes to adopt a 
definition of ``health program or activity.'' The 2016 Rule contained 
such a definition. Among other things, the 2016 Rule defined ``health 
program or activity'' to include all of the operations of entities 
principally engaged in health services, health insurance coverage, or 
other health-related coverage, including ``a hospital, health clinic, 
group health plan, health insurance issuer, physician's practice, 
community-based health care providers, nursing facility, residential or 
community-based treatment facility, or other similar entity.'' \250\ In 
contrast, the 2020 Rule does not provide a definition but rather 
addresses the term ``health program or activity'' in the application 
section of the rule at Sec.  92.3(b). While defining ``health program 
or activity'' to encompass ``all of the operations of entities 
principally engaged in the business of providing health care,'' the 
2020 Rule explicitly provides that ``an entity principally or otherwise 
engaged in the business of providing health insurance shall not, by 
virtue of such provision, be considered to be principally engaged in 
the business of providing health care.'' \251\
---------------------------------------------------------------------------

    \250\ Former 45 CFR 92.4.
    \251\ 45 CFR 92.3(b), (c) (emphasis added).
---------------------------------------------------------------------------

    The Department believes that returning to a definition of ``health 
program or activity'' provides covered entities with important 
information regarding the types of operations that will be covered for 
purposes of this proposed rule. Whereas Title VI, Section 504, and the 
Age Act apply to all federally funded programs or activities, Section 
1557 applies only to health programs or activities, just as Title IX 
applies only to education programs or activities. In determining the 
application of Section 1557, therefore, the Department has looked to 
the analogous ways in which ``education program or activity'' is 
understood under Title IX.
    In paragraph (a), we propose to define health program or activity 
to mean any project, enterprise, venture or undertaking to provide or 
administer health-related services, health insurance coverage, or other 
health-related coverage; provide assistance to persons in obtaining 
health-related services, health insurance coverage, or other health-
related coverage; provide clinical, pharmaceutical, or medical care; 
engage in health research; or provide health education for health care 
professionals or others. Coverage of health research and health 
education was discussed in the preamble to the 2016 Rule \252\ but 
neither was mentioned in the 2020 Rule or preamble.
---------------------------------------------------------------------------

    \252\ 81 FR 31385.
---------------------------------------------------------------------------

    It has long been understood under the ``fungibility of funds'' 
rationale that Title IX applies to all the operations of entities 
principally engaged in educational functions, primarily on the theory 
that funds provided to such an entity invariably subsidize education 
operations. So, for instance, Title IX applies to not only the 
``traditional educational operations'' of such an institution but also 
to ``faculty and student housing, campus shuttle bus service, campus 
restaurants, the bookstore, and other commercial activities.'' \253\ 
Likewise, it is fair to assume Congress intended the nondiscrimination 
requirements of Section 1557 to apply categorically to entities 
principally engaged in the provision or administration of health-
related activities, based upon the same ``fungibility of funds'' 
rationale. Indeed, Section 1557 specifically applies to ``any health 
program or activity, any part of which is receiving Federal financial 
assistance,'' \254\ which appears to contemplate the application of 
such a ``fungibility of funds'' understanding.
---------------------------------------------------------------------------

    \253\ S. Rep. No. 64 at 17, reprinted in 1988 U.S.C.C.A.N. at 
19; see also U.S. Dep't of Justice, Title IX Legal Manual, sec. 
C.3., n. 28 (citing H.R. Rep. No. 98-829, at 27 (1984), and noting 
that though this comment was made in reference to an earlier draft 
of the CRRA, ``sponsors of the CRRA, as eventually enacted, later 
noted that, despite the new language, coverage would operate in the 
same manner envisioned for the prior bill'').
    \254\ 42 U.S.C. 18116(a) (emphasis added).
---------------------------------------------------------------------------

    The Department, at paragraph (b), thus proposes to define ``health 
program or activity'' to include all of the operations of any entity 
principally engaged in the provision or administration of health 
projects, enterprises, ventures, or undertakings described in paragraph 
(a). Such entities include but are not limited to a: state or local 
health agency; hospital; health clinic; health insurance issuer; 
physician's practice; pharmacy; community-based health care provider; 
nursing facility; residential or community-based treatment facility; or 
other similar entity or combination thereof. We are proposing that 
whether such entities are administered by a government or a private 
entity, all of their operations would be covered under this part.\255\ 
The 2016 Rule contained a similar provision, which also specifically 
referred to ``all of the operations of a State Medicaid program, a 
Children's Health Insurance Program, and the Basic Health Program.'' 
\256\ We do not propose to expressly list Medicaid programs, CHIP, or 
the Basic Health Program in paragraph (b) because we believe they would 
be covered in their entirety as operations of state or local health 
agencies. We seek comment as to whether such programs should be 
explicitly referenced in the regulatory language.
---------------------------------------------------------------------------

    \255\ See, e.g., Fain v. Crouch, 545 F. Supp. 3d 338, 343 
(S.D.W. Va. 2021) (holding that defendant health plan was, ``by 
virtue of its acceptance of Federal assistance under its Medicare 
Advantage program,'' required to comply with Section 1557 ``under 
its entire portfolio'').
    \256\ Former 45 CFR 92.4 (defining ``health program or 
activity'').
---------------------------------------------------------------------------

    Unlike under the 2020 Rule, we propose to apply this rule to all 
the operations of a recipient entity principally engaged in the 
provision or administration of health insurance coverage or other 
health-related coverage. We believe that the most natural reading of 
the language ``health program or activity'' in the statute encompasses 
health insurance programs or activities. In the preamble to the 2020 
Rule, the Department emphasized that the provision of health-care 
insurance is not necessarily a form of healthcare. Whether or not that 
is true in any practical sense for purposes that bear on the 
application of nondiscrimination protections, the applicability of 
Section 1557 does not turn on whether a program or activity involves 
health care as such--it depends instead on whether the operations in 
question are a ``health program or activity''--something that 
unequivocally describes the operations of health insurance 
issuers.\257\
---------------------------------------------------------------------------

    \257\ See, e.g., Fain, 545 F. Supp. 3d at 342 (`` `health 
program or activity' under Section 1557 necessarily includes health 
insurance issuers'').
---------------------------------------------------------------------------

    This straightforward textual reading is reinforced by the ACA's 
structure and clear indicia of the statute's purpose. Section 1557 
forms a key part of the ACA--a law that itself focuses on health 
insurance market reforms as a means of expanding access to and 
provision of health care. Given the ACA's focus on

[[Page 47845]]

health insurance and other health-related coverage, if Congress 
intended to exclude health insurance from Section 1557's reach, it is 
logical to assume that it would have done so expressly.
    In enacting the ACA, Congress showed a clear intent to protect 
individuals from discrimination in health insurance and other health-
related coverage and to regulate the content of such coverage. As 
further evidence that Congress intended the ACA to prohibit 
discriminatory practices in health insurance and other health-related 
coverage, in addition to the protections against discrimination 
afforded under Section 1557, Congress enacted the ACA's market reforms 
that prohibited certain common discriminatory practices in health 
insurance benefit designs.\258\
---------------------------------------------------------------------------

    \258\ 42 U.S.C. 18022(b)(4)(B)-(C) (in defining essential health 
benefits, the Secretary of HHS must ``take into account the health 
care needs of diverse segments of the population, including women, 
children, persons with disabilities, and other groups,'' and ``not 
make coverage decisions . . . or design benefits in ways that 
discriminate against individuals because of their age, disability, 
or expected length of life''); 18031(c)(1)(A) (criteria for 
qualified health plans require plans to ``not employ marketing 
practices or benefit designs that have the effect of discouraging 
the enrollment in such plan by individuals with significant health 
needs''); 300gg (prohibiting discriminatory premium rates by 
limiting rating factors to only include family size, geographic 
rating area, age, and tobacco use); 300gg-4 (prohibiting 
discrimination against individual participants and beneficiaries 
based on health status by prohibiting establishment of rules for 
eligibility (including continued eligibility) based on the following 
health-status-related factors: (1) Health status; (2) Medical 
condition (including both physical and mental illnesses); (3) Claims 
experience; (4) Receipt of health care; (5) Medical history; (6) 
Genetic information; (7) Evidence of insurability (including 
conditions arising out of acts of domestic violence); (8) 
Disability; (9) Any other health status-related factor determined 
appropriate by the Secretary).
---------------------------------------------------------------------------

    By including a nondiscrimination provision in Title I of the ACA, a 
title of the health care law that predominantly addresses access to and 
the design of health insurance and other health-related coverage, 
Congress demonstrated an intent to apply the non-discrimination 
provision to health insurance issuers that receive financial support 
from the Federal Government. Private health insurance issuers play a 
critical role in ensuring that people are able to receive care within 
the current health care system. Issuers exercise significant control 
over enrollees' ability to access their health care by strongly 
influencing which providers they see, which hospitals they visit, and 
which treatments or medications they receive.\259\ Indeed, a recent 
district court opinion on this issue found that, by virtue of being the 
``gatekeeper'' of the plaintiff's health care, a health plan qualified 
as a `` `health program' that Congress intended to rid of 
discrimination.'' \260\ This proposed rule is consistent with that 
reading.
---------------------------------------------------------------------------

    \259\ Additionally, many health insurance issuers are directly 
involved in the provision of care through administration of a health 
maintenance organization (HMO). An HMO is a health insurance plan 
that usually limits coverage to care from doctors who work for or 
contract with the HMO.
    \260\ Fain, 545 F. Supp. 3d at 342 (holding that defendant 
health plan was a ``health program or activity'' for purposes of 
Section 1557 jurisdiction).
---------------------------------------------------------------------------

    We note that the 2016 Rule included group health plans \261\ as 
among the entities that were categorically covered for all of their 
operations. We propose to not explicitly include group health plans in 
the non-exhaustive list of entities identified in proposed paragraph 
(b). Although we still consider group health plans to be principally 
engaged in providing or administering health programs or activities 
described in paragraph (a), many group health plans themselves are not 
recipients of Federal financial assistance (as opposed to the employer 
or plan sponsor offering the group health plan or the third party 
administrator administering the group health plan), so inclusion of 
group health plans on the list may be confusing. That said, if the 
Department receives a complaint against a group health plan, we will 
evaluate the facts on a case-by-case basis to determine whether the 
group health plan is a covered entity subject to this part.
---------------------------------------------------------------------------

    \261\ ``Group health plan'' is defined as ``an employee welfare 
benefit plan to the extent that the plan provides medical care (as 
defined in paragraph (2) and including items and services paid for 
as medical care) to employees or their dependents (as defined under 
the terms of the plan) directly or through insurance, reimbursement, 
or otherwise. Such term shall not include any qualified small 
employer health reimbursement arrangement (as defined in section 
9831(d)(2) of Title 26).'' 29 U.S.C. 1191b(a)(1); see also 42 U.S.C. 
300gg-91(a). ``Employee welfare benefit plan'' is defined as ``any 
plan, fund, or program which was heretofore or is hereafter 
established or maintained by an employer or by an employee 
organization, or by both, to the extent that such plan, fund, or 
program was established or is maintained for the purpose of 
providing for its participants or their beneficiaries, through the 
purchase of insurance or otherwise, (A) medical, surgical, or 
hospital care or benefits, or benefits in the event of sickness, 
accident, disability, death or unemployment, or vacation benefits, 
apprenticeship or other training programs, or day care centers, 
scholarship funds, or prepaid legal services, or (B) any benefit 
described in section 186(c) of this title (other than pensions on 
retirement or death, and insurance to provide such pensions).'' 29 
U.S.C. 1002(1).
---------------------------------------------------------------------------

    We note that even if the Department determines that a group health 
plan is not covered under this part, other entities that contract with 
a group health plan or a sponsor of a group health plan may be covered 
entities. For example, recipient health insurance issuers principally 
engaged in providing or administering health insurance coverage would 
be covered for health insurance they provide to a fully-insured group 
health plan and also for third party administrator activities that they 
are responsible \262\ for providing in a self-funded group health 
plan.\263\ The Department will evaluate the facts on a case-by-case 
basis to determine whether other entities that contract with a group 
health plan are covered entities subject to this part. Further, though 
a group health plan may not be covered under Section 1557, it may still 
be subject to other Federal nondiscrimination requirements. For 
example, group health plans and health insurance issuers offering non-
grandfathered group or individual health insurance coverage are 
prohibited from establishing any rule for eligibility, benefits, or 
premiums or contributions that discriminates based on any health 
factor.\264\
---------------------------------------------------------------------------

    \262\ See, e.g., Tovar v. Essentia Health, 857 F.3d 771, 778 
(8th Cir. 2017) (holding that a third party administrator could be 
liable under Section 1557 for damages arising from discriminatory 
terms in a self-funded employer-provided health plan if the third 
party administrator provided the employer with a discriminatory plan 
document, notwithstanding the fact that the employer subsequently 
adopted the plan and maintained control over its terms).
    \263\ See discussion infra under proposed Sec.  92.207 on 
application to third party administrators.
    \264\ 45 CFR 147.110 (HHS); 29 CFR 2590.715-2705 (Department of 
Labor); 26 CFR 54.9815-2705 (Department of the Treasury). We note 
that grandfathered and non-grandfathered group health plans and 
health insurance issuers offering health insurance coverage in 
connection with a group health plan are prohibited from establishing 
any rule for eligibility, benefits, or premiums or contributions 
that discriminates based on any health factor pursuant to 45 CFR 
146.121 (HHS); 29 CFR 2590.702 (Department of Labor); 26 CFR 
54.9802-1 (Department of the Treasury).
---------------------------------------------------------------------------

    We seek comment on the circumstances under which a group health 
plan might receive funds that could be considered Federal financial 
assistance from the Department, including the type and prevalence of 
funds received that could be considered Federal financial assistance 
under this part.
    Finally, we emphasize that proposed paragraph (b) is not intended 
to serve as an exhaustive list of those entities HHS believes would 
qualify as principally engaged in the provision or administration of 
health programs or activities described in paragraph (a). For example, 
we propose to expressly refer to hospitals but not to refer to other 
common names, such as medical centers, for the same or similar 
entities. Similarly, we propose not to expressly include hospital 
systems or healthcare systems, even though in many instances they will 
fall within the scope of

[[Page 47846]]

paragraph (b). For example, under proposed (b), the rule could cover 
all of the operations of a non-profit healthcare system operating five 
hospitals, depending on the specific facts. HHS will evaluate the 
facts, on a case-by-case basis, to determine whether an entity falls 
within the scope of paragraph (b)'s categorical coverage. We invite 
comments on whether it is important to add any other entities to the 
list in (b) in order to further clarify coverage.
    Machine translation. We propose to define ``machine translation'' 
as automated translations, without the assistance of or review by a 
qualified human translator, that are text-based and provide instant 
translations between various languages, sometimes with an option for 
audio input or output. This is in contrast to human translation, which 
is context-based and captures the intended meaning of the source. This 
definition is based on literature addressing the use of machine 
translation in the clinical setting, which we believe captures the 
automated translations that are being used in the health care 
setting.\265\ We seek comment on the adequacy of this definition.
---------------------------------------------------------------------------

    \265\ Gudeeshpal Randhawa et al., Using Machine Translation in 
Clinical Practice, 59 Can. Fam. Physician 328 (2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3625087/pdf/0590382.pdf.
---------------------------------------------------------------------------

Assurances Required (Sec.  92.5)

    This proposed rule would retain the requirement of the 2016 and 
2020 Rules for recipients to submit assurances of compliance to the 
Department. One method that the Federal Government uses to ensure civil 
rights compliance is to require covered entities to submit assurances 
of compliance when applying for Federal financial assistance. The 
assurances and related certification documents remind covered entities 
of their civil rights obligations and can also assist the Department in 
pursuing an independent contract claim for enforcement of 
nondiscrimination requirements.\266\
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    \266\ See, e.g., Dep't of Justice, Guidelines for the 
Enforcement of Title VI, Civil Rights Act of 1964, 28 CFR 50.3, pt. 
I.B.1 (listing various ``[p]ossibilities of judicial enforcement,'' 
including suits to enforce contractual assurances).
---------------------------------------------------------------------------

    Specifically, proposed Sec.  92.5 is the same as Sec.  92.4 of the 
2020 Rule. In proposed paragraph (a), each entity applying for Federal 
financial assistance, each issuer seeking certification to participate 
in a Health Insurance Exchange, and each state seeking approval to 
operate a State Exchange is required to submit an assurance that its 
health programs and activities will be operated in compliance with 
Section 1557, Title VI, Title IX, Section 504, and the Age Act. The 
duration of obligation (proposed paragraph (b)), and covenants language 
(proposed paragraph (c)) adopt the corresponding requirements found in 
the Section 504 regulation at 45 CFR 84.5.

Remedial Action and Voluntary Action (Sec.  92.6)

    The Department proposes to include requirements regarding remedial 
and voluntary action, which would reinstate former Sec.  92.6 in the 
2016 Rule. The 2020 Rule repealed former Sec.  92.6, stating that it 
was duplicative and overlapped with existing civil rights laws and 
regulations, and therefore would cause confusion about the 
responsibilities of covered entities.\267\ The regulations implementing 
Title IX, Section 504, and the Age Act do require a covered entity to 
take voluntary action upon a determination that the entity engaged in 
discriminatory conduct.\268\ The Department believes that, rather than 
causing confusion, proposed Sec.  92.6 clarifies that Section 1557 also 
requires covered entities that have engaged in discriminatory conduct 
with respect to their health programs and activities in violation of 
this part to take voluntary actions to remediate the effects of such 
discriminatory conduct. Where a covered entity is required to take 
remedial actions under Title VI, Section 504, Title IX, or the Age Act, 
such actions would likely satisfy the remedial actions required by 
proposed Sec.  92.6.
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    \267\ See 85 FR 37160, 37162 (June 19, 2020).
    \268\ 45 CFR 86.3(a)-(b) (Title IX); Sec.  84.6(a)-(b) (Section 
504); Sec.  91.48 (Age Act).
---------------------------------------------------------------------------

Designation and Responsibilities of a Section 1557 Coordinator (Sec.  
92.7)

    Proposed Sec.  92.7(a) requires covered entities with 15 or more 
employees to designate at least one employee to serve as a Section 1557 
coordinator (Section 1557 Coordinator) to coordinate their efforts to 
comply with and carry out the covered entity's responsibilities under 
Section 1557 and this part with regard to their health programs and 
activities. The 2016 Rule similarly required covered entities of this 
size to designate a compliance coordinator for Section 1557 at former 
Sec.  92.7. We newly propose to permit covered entities to, as 
appropriate, assign one or more designees to carry out some of the 
responsibilities of the Section 1557 Coordinator. The 2016 Rule did not 
include this provision, and we include it here in recognition that some 
covered entities may want or need to spread the duties of the Section 
1557 Coordinator over multiple staff. However, the Section 1557 
Coordinator must retain ultimate oversight for ensuring coordination 
with the covered entity's compliance.
    In 2020, the Department repealed the requirement for each covered 
entity with 15 or more employees to designate a Section 1557 
Coordinator or ``designated employee,'' reasoning that to the extent 
that the implementing regulations for the referenced statutes ``have 
responsible employee and grievance procedures, they are sufficient for 
enforcement of Section 1557.'' \269\ We believe that a designated 
Section 1557 Coordinator will help ensure covered entities comply with 
the requirements of Section 1557. Additionally, a designated Section 
1557 Coordinator will better allow covered entities to resolve 
potential grievances as accurately and efficiently as possible, to the 
benefit of individuals seeking care as well as the covered entity.
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    \269\ 85 FR 37204.
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    The Department recognizes that covered entities with 15 or more 
employees may have retained their Section 1557 Coordinators required by 
the 2016 Rule even though the 2020 Rule does not require covered 
entities to do so. Under proposed Sec.  92.7, those covered entities 
that have retained their Section 1557 Coordinators need not appoint a 
new one, though the existing Section 1557 Coordinator would be 
responsible for the responsibilities outlined in proposed paragraph 
(b).
    The implementing regulations for Section 504 and Title IX require 
covered entities to designate a responsible employee to coordinate the 
covered entity's civil rights compliance, and the Title VI and Age Act 
regulations do not explicitly include such a requirement.\270\ A 
covered entity that has already designated a responsible employee 
pursuant to the Section 504 or Title IX regulations may assign that 
individual to coordinate the covered entity's efforts to comply with 
Section 1557, provided that the scope of the individual's 
responsibilities is modified to include all prohibited bases of 
discrimination included in Section 1557 and other duties as required. 
Like the 2016 Rule, proposed Sec.  92.7(a) standardizes the requirement 
for covered entities that employ more than 15 people to designate a 
Section 1557 Coordinator.
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    \270\ 45 CFR 84.7(a) (Section 504); Sec.  86.8(a) (Title IX).
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    At proposed paragraph (b), we provide a list of responsibilities of 
the Section 1557 Coordinator. The 2016 Rule did not include a similar 
provision. The Department proposes to

[[Page 47847]]

include a list of responsibilities to assist covered entities in 
developing a position description for the Section 1557 Coordinator and 
to identify the provisions over which Coordinators must have direct 
responsibility. Proposed responsibilities include, at a minimum, that 
the covered entity ensure that the Section 1557 Coordinator: (1) 
receives, reviews, and processes grievances filed under the grievance 
procedure as set forth in proposed Sec.  92.8(c); (2) coordinates the 
covered entity's recordkeeping requirements as set forth in proposed 
Sec.  92.8(c); (3) coordinates effective implementation of the covered 
entity's language access procedures as set forth in proposed Sec.  
92.8(d); (4) coordinates effective implementation of the covered 
entity's effective communication procedures as set forth in proposed 
Sec.  92.8(e); (5) coordinates the covered entity's procedures for 
providing reasonable modifications for individuals with disabilities in 
accordance with proposed Sec.  92.8(f); and (6) coordinates training of 
relevant employees as set forth in proposed Sec.  92.9, including 
maintaining the required documentation.
    We seek comment on this requirement, including whether OCR should 
require covered entities with fewer than 15 employees to designate a 
Section 1557 Coordinator and, if so, whether there should be a 
requisite number of employees or whether all covered entities should be 
required to designate a Section 1557 Coordinator. We are particularly 
interested in hearing from smaller covered entities who have a civil 
rights coordinator about whether they believe there is a benefit to 
having such a dedicated staff member, and any associated costs or 
burdens. We further seek comment on whether the enumeration of 
responsibilities of the Section 1557 Coordinator is beneficial and 
sufficiently comprehensive. We also seek comment on how the Department 
can support Section 1557 Coordinators, including through the provision 
of training, so that they understand their duties, the protections 
afforded by Section 1557, and the rationale for both.

Policies and Procedures (Sec.  92.8)

    Proposed Sec.  92.8 would require covered entities to develop and 
implement written policies and procedures that are designed to 
facilitate compliance with the requirements of this part. The 
Department recognizes that, taken alone, the implementing regulations 
for the statutes referenced in Section 1557 may require entities to 
undertake different processes depending on the alleged basis of 
discrimination.
    This rulemaking provides for more consistency regardless of whether 
an allegation of discrimination in a covered health program or activity 
is based on race, color, national origin, sex, age, or disability--or 
some combination thereof. The 2020 Rule fails to account for claims of 
discrimination in health programs and activities that are alleged to 
have occurred based on multiple protected bases. The Department 
believes that establishing procedural requirements across 
nondiscrimination bases is important because it benefits the public and 
covered entities, and it streamlines OCR's enforcement scheme. For the 
public, providing consistent regulatory procedural requirements across 
nondiscrimination bases recognizes the potential for complaints 
alleging discrimination on multiple bases (e.g., sex and race). Covered 
entities would gain clarity with respect to their regulatory procedural 
requirements without any confusion as to whether different provisions 
apply depending on the protected basis. For example, there are 
currently questions as to whether or not the 2020 Rule requires covered 
entities to have a responsible employee and grievance procedure to 
address issues of sex discrimination, or if that is only required to 
the extent that it would be required under Title IX (i.e., whether the 
health program and activity must also be an education program or 
activity to trigger the requirement).
    This proposed section would require each covered entity, in its 
health programs and activities, to adopt and implement a 
nondiscrimination policy, grievance procedures (for covered entities 
employing 15 or more persons), language access procedures, auxiliary 
aids and services procedures, and procedures for reasonable 
modifications for individuals with disabilities (collectively, 
``Section 1557 Policies and Procedures''). We recognize that the 
covered entities vary significantly in size, nature of business, and 
location and accordingly recognize that each covered entity's Section 
1557 Policies and Procedures may vary. OCR is committed to supporting 
covered entities as they develop policies and procedures and is 
planning to provide sample documents on the Department's website. Given 
the prevalence of covered entities with fewer than 15 employees that 
provide health care services to a significant volume of patients, the 
Department highly encourages such covered entities to implement Section 
1557 Policies and Procedures based on the sample documents that will be 
available on the agency website. The Department underscores that 
covered entities with fewer than 15 employees would still be prohibited 
from discriminating in health programs and activities under Section 
1557, even if those entities are not required to adopt grievance 
procedures, or to hire a Section 1557 Coordinator, under this proposed 
rulemaking.
    The Department's goal is to address potential compliance issues and 
help resolve civil rights concerns at an early stage, avoiding the need 
for an OCR investigation. The Department has also heard from a range of 
stakeholders that it is important to include proactive measures to 
increase covered entities' knowledge of their responsibilities under 
Section 1557. The proposed complementary civil rights policies and 
procedures advance these objectives.
    This proposed requirement is also informed by OCR's enforcement 
experience. It is common that, either during or following an 
investigation, OCR will enter into a voluntary resolution agreement 
with a covered entity that requires the adoption and implementation of 
nondiscrimination policies as well as procedures for providing 
auxiliary aids and services and reasonable modifications for 
individuals with disabilities, and language assistance services for LEP 
individuals.\271\ OCR's resolution agreements require these 
interventions, in part, because our experience generally demonstrates 
that targeting such interventions at the underlying

[[Page 47848]]

problems can result in covered entities being better positioned to 
prevent discriminatory conduct in the future.
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    \271\ See, e.g., Voluntary Resolution Agreement between U.S. 
Dep't of Justice, U.S. Dep't Health & Human Servs., Office for Civil 
Rights & William W. Backus Hosp. (2021), https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/agreements/vra-between-doj-hhs-ocr-william-backus-hospital/index.html; Voluntary Resolution 
Agreement between U.S. Dep't of Health & Human Servs., Office for 
Civil Rights & CHRISTUS Trinity Mother Frances Health Sys. (2020), 
https://www.hhs.gov/sites/default/files/christus-vra.pdf; Voluntary 
Resolution Agreement between U.S. Dep't of Health & Human Servs., 
Office for Civil Rights & Mid-Maryland Musculoskeletal Inst. (2019), 
https://www.hhs.gov/sites/default/files/MMI-vra.pdf; https://www.hhs.gov/sites/default/files/uconn-vra.pdf; Voluntary Resolution 
Agreement between U.S. Dep't of Health & Human Servs., Office for 
Civil Rights & Pa. Dep't of Human Servs. (2019), https://public3.pagefreezer.com/content/HHS.gov/31-12-2020T08:51/https://www.hhs.gov/sites/default/files/hhs-padhs-vra.pdf; Voluntary 
Resolution Agreement between U.S. Dep't of Justice, U.S. Dep't 
Health & Human Servs., Office for Civil Rights & Univ. of Vt. Med. 
Ctr. (2017), https://www.hhs.gov/sites/default/files/uvmmc-vra.pdf; 
Voluntary Resolution Agreement between U.S. Dep't of Health & Human 
Servs., Office for Civil Rights & Erie Cty. Dep't of Soc. Servs. 
(2016), https://www.hhs.gov/sites/default/files/ecdss-vra-final.pdf; 
Voluntary Resolution Agreement between U.S. Dep't of Justice, U.S. 
Dep't Health & Human Servs., Office for Civil Rights & St. Francis 
Hosp. & Med. Ctr. (2015), https://www.hhs.gov/sites/default/files/stfrancishospital-vra.pdf.
---------------------------------------------------------------------------

    Through the implementation of Section 1557 Policies and Procedures, 
a covered entity's employees will be better equipped to provide 
services in a nondiscriminatory manner. For example, an employee will 
be able to refer to the covered entity's official policy for providing 
LEP individuals with language assistance services; such policies will 
also be interpreted or translated as needed, and be available to an LEP 
individual or their representative. Overall, the covered entity's 
policies and procedures should bring consistency to the covered 
entity's health programs and activities and improve compliance.
    Finally, we note that many health care providers have adopted 
policies and procedures required under OCR's existing civil rights 
authorities and therefore would only need to review and update such 
policies and procedures rather than creating them anew. For example, 
this provision is consistent with OCR's civil rights clearance process 
required of providers seeking initial certification or undergoing a 
change of ownership to be certified as a Medicare Part A provider by 
CMS.\272\ In order to obtain a civil rights clearance, would-be 
Medicare Part A providers and businesses must have nondiscrimination 
policies and procedures, including: policies and procedures to identify 
and communicate orally and in writing with LEP individuals; policies 
and procedures to ensure effective communication for individuals with 
disabilities, including, where necessary, the provision of appropriate 
auxiliary aids and services; and a description of how Medicare 
providers and applicants make their program accessible to persons with 
disabilities, among other things.\273\ This proposed provision would 
establish similar obligations. Under this proposed provision, covered 
entities may need to revise any pre-existing policies and procedures to 
ensure they, at minimum, include the proposed required content.
---------------------------------------------------------------------------

    \272\ See Civil Rights Clearance for Medicare Provider 
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil 
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/index.html (last updated Oct. 26, 2021).
    \273\ See Technical Assistance for Medicare Providers and 
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil 
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/technical-assistance/index.html (last updated 
Oct. 27, 2021).
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    The Department acknowledges that requiring covered entities to 
develop and implement Section 1557 Policies and Procedures for their 
health programs and activities would be a departure from previous 
rulemakings, under which covered entities that implemented such 
policies and procedures did so voluntarily. However, the Department's 
enforcement and compliance assistance experience demonstrates that 
interventions such as implementing policies and procedures can result 
in covered entities being better positioned to prevent discriminatory 
conduct and to better avoid the risk of an employee providing services 
in a discriminatory manner. Thus, we are proposing the Section 1557 
Policies and Procedures requirement because we believe that the lack of 
such a requirement leaves individuals more susceptible to 
discrimination and covered entities more susceptible to violations. 
Specifically, as noted above, we believe that such a proactive measure 
will more effectively increase covered entities' employees' knowledge 
of their responsibilities under Section 1557. The Department 
acknowledges that Section 1557 Policies and Procedures are not a 
panacea for eliminating discrimination in health care; however, we 
emphasize that our experience has indicated that implementing policies 
and procedures that are the same or similar to the proposed Section 
1557 Policies and Procedures helps prevent future instances of 
discriminatory conduct.
    Proposed paragraph (a) of this section requires covered entities to 
implement written Section 1557 Policies and Procedures. The policies 
and procedures must include an effective date and be reasonably 
designed, taking into account the size, complexity, and the type of 
health programs or activities undertaken by a covered entity, to ensure 
compliance with this part.
    Proposed paragraph (b) requires each covered entity to implement a 
written nondiscrimination policy that, at minimum, provides the contact 
information for the Section 1557 Coordinator (if applicable) and states 
that the covered entity in its health programs and activities: does not 
unlawfully discriminate on the basis of race, color, national origin 
(including limited English proficiency and primary language), sex 
(including pregnancy, sexual orientation, gender identity, and sex 
characteristics), age, or disability; and provides language assistance 
services and appropriate auxiliary aids and services free of charge, 
when necessary for compliance with Section 1557 or this part.
    Proposed paragraph (c) addresses the requirements for covered 
entities with 15 or more employees with regard to grievance procedures 
and recordkeeping in their health programs and activities, including 
ensuring that the grievance procedure is accessible to LEP individuals 
and individuals with disabilities.
    In proposed paragraph (c)(1), OCR is proposing to require that 
covered entities with more than 15 employees establish written civil 
rights grievance procedures. This is similar to the 2016 Rule at former 
Sec.  92.7, except that we propose to include a record retention 
requirement. The 2020 Rule repealed former Sec.  92.7 and provided that 
certain covered entities need only have a grievance procedure to the 
extent the referenced statutes require it.\274\ We believe that the 
requirement in proposed paragraph (c)(1) will restore consistency of 
requirements for covered entities that existed under former Sec.  92.7. 
It is also responsive to data related to improving health care visits 
for historically marginalized communities, which indicate that a 
majority of patients in these communities desire a method for 
submitting grievances to health care providers so that the providers 
can address the patients' problems.\275\ Though the referenced data did 
not identify whether patients desired a mechanism to submit 
discrimination grievances specifically, the data support the 
supposition that, for patients of color, trust in their health care 
providers would increase if these patients could voice their concerns 
directly to their health care providers, thus, improving these 
patients' overall health care experiences. Accordingly, the 
Department's proposed Sec.  92.8(c) provides a mechanism for patients 
to raise allegations of discrimination directly to their respective 
health care providers. We expect covered entities to tailor the sample 
grievance procedure to fit their different needs for flexibility, 
efficiency, and cost effectiveness.
---------------------------------------------------------------------------

    \274\ 85 FR 37160, 37204 (Jun. 19, 2020) (``To the extent that 
[the referenced statutes'] implementing regulations have . . . 
grievance procedures, they are sufficient for enforcement of Section 
1557.'').
    \275\ Leslie Read et al., The Deloitte Ctr. for Health 
Solutions, Rebuilding Trust in Health Care: What Do Consumers Want--
and Need--Organizations to Do?, p. 3 (2021) (``62% [of surveyed 
people of color] want their local hospitals to ensure patients have 
a voice to relay their experiences and take action to address their 
problems.''), https://www2.deloitte.com/content/dam/insights/articles/US164518_CHS-Equity-trust/DI_Rebuilding-trust-in-healthcare.pdf.
---------------------------------------------------------------------------

    At paragraph (c)(2), we propose that a covered entity must retain 
records related to grievances filed with it that allege discrimination 
on the basis of race, color, national origin, sex, age, or disability 
in its health programs and activities for no less than three (3) years 
from the date of the filing of the

[[Page 47849]]

grievance. The records must include the grievance; the name and contact 
information of the complainant (if provided by the complainant); the 
alleged discriminatory action and alleged basis (or bases) of 
discrimination; the date the grievance was filed; the grievance 
resolution; and any other pertinent information. Pertinent information 
includes, to the extent relevant to a particular complaint, information 
related to the complainant's national origin (including limited English 
proficiency and primary language), sex (including pregnancy, sexual 
orientation, gender identity, or sex characteristics), etc.
    Through its enforcement experience, OCR has found that obtaining 
records of past grievances from covered entities is an important and 
informative component of a thorough investigation, as it assists OCR in 
identifying potential patterns or practices of discrimination that may 
not otherwise be apparent while reviewing a single OCR discrimination 
complaint. For example, if OCR receives a single discrimination 
complaint from a person giving birth alleging discrimination on the 
basis of race, OCR could review the grievances submitted to a covered 
entity to identify the presence or absence of any potential patterns of 
discrimination against people giving birth on the basis of race. 
Without a requirement to retain grievances for a period of time, it is 
more difficult for OCR to identify potential patterns or practices of 
discrimination. This requirement will assist OCR not only in 
identifying the scope of concern, but also in crafting appropriate 
technical assistance and complaint resolutions.
    OCR understands that retaining grievances for a specified period of 
time is already the practice of some covered entities. This requirement 
seeks to make the practice more consistent, thereby allowing OCR to 
better identify potential patterns or practices of discrimination 
during complaint investigations and compliance reviews. Having access 
to discrimination complaints over a period of time will also allow 
covered entities to be proactive in identifying potential patterns or 
practices of discrimination, which will allow them to take corrective 
actions, if necessary, before a complaint is filed with OCR. We believe 
the three-year record retention requirement strikes the right balance 
between covered entities' burden concerns and the need for access to 
this vital information. However, while we propose to require records to 
be kept for three (3) years, nothing in the proposed rule will prevent 
covered entities from keeping their records for a longer period of time 
if the recipient wishes or due to other legal obligations.\276\
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    \276\ For example, the Department of Education Title IX 
regulation requires recipients to keep records related to Title IX 
sexual harassment grievances and investigations for a period of 
seven (7) years. 34 CFR 106.45(b)(10).
---------------------------------------------------------------------------

    Proposed paragraph (c)(3) requires that a covered entity keep 
confidential the identity of an individual who has filed a grievance, 
except as required by law or to the extent necessary to carry out the 
purposes of this proposed regulation, including the conduct of any 
investigation.
    We seek comment on the record retention requirement, particularly 
with regard to patient privacy concerns or concerns regarding 
potentially unauthorized use of information included in such records. 
We seek comment on best practices for record retention of grievance 
procedures, including strategies for ensuring patient privacy.
    Rather than requiring health programs and activities of the 
Department to adopt separate grievance procedures, the 2016 Rule 
provided that, for the Department, the procedures for addressing 
complaints of discrimination under Section 1557 would be deemed the 
required grievance procedures under this section. We decline to 
reinstate this approach, as individuals and the Department's health 
programs and activities can also benefit from a process for covered 
entities to address any potential compliance issues at an earlier stage 
and in a less formal manner than an OCR investigation. However, 
individuals may opt not to use a health program or activity's grievance 
procedure and may elect to file a complaint with OCR at any time, 
regardless of whether the health program or activity is conducted by a 
recipient, the Department, or a Title I entity.
    Proposed paragraph (d) requires covered entities to develop and 
implement written language access procedures to support compliance with 
requirements to take reasonable steps to provide meaningful access to 
LEP individuals in their health programs and activities under proposed 
Sec.  92.201. Given existing requirements to provide language 
assistance to LEP individuals under Title VI and Section 1557, informed 
by the Department's ``2003 Guidance to Federal Financial Assistance 
Recipients Regarding Title VI Prohibition Against National Origin 
Discrimination Affecting Limited English Proficient Persons'' (HHS LEP 
Guidance),\277\ we anticipate that some covered entities may have 
already implemented policies and procedures akin to this requirement. 
Additionally, Federal agencies have been required to have language 
access procedures since 2000, as provided for in E.O. 13166,\278\ and 
the Department itself has a Language Access Plan.\279\ This requirement 
is also consistent with the civil rights clearance process required for 
Medicare Part A providers, which requires policies and procedures to 
identify and communicate orally and in writing with LEP 
individuals.\280\
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    \277\ 68 FR 47311, 47316 (Aug. 8, 2003).
    \278\ 65 FR 50121 (Aug. 16, 2000).
    \279\ U.S. Dep't of Health & Human Servs., Language Access Plan 
(2013), https://www.hhs.gov/sites/default/files/open/pres-actions/2013-hhs-language-access-plan.pdf.
    \280\ Technical Assistance for Medicare Providers and 
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil 
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/technical-assistance/index.html (last updated 
Oct. 27, 2021).
---------------------------------------------------------------------------

    We propose that, at a minimum, a covered entity's language access 
procedures must include information detailing the contact information 
for the Section 1557 Coordinator (if applicable); how an employee 
identifies whether an individual is LEP; how an employee obtains the 
services of qualified interpreters and translators the covered entity 
uses to communicate with LEP individuals; the names of any qualified 
bilingual or multilingual staff members; and a list and the location of 
any electronic and written translated materials the covered entity has, 
the languages they are translated into, and the publication date. We 
note that covered entities have a duty to translate that extends beyond 
those documents that have already been translated at the time this list 
is made, and the list should be updated periodically.
    Proposed paragraph (e) requires covered entities to develop and 
implement written effective communication procedures to support 
compliance with requirements to take appropriate steps to ensure that 
communications in their health programs and activities with individuals 
with disabilities are as effective as communications with individuals 
without disabilities under proposed Sec.  92.202. We propose that, at a 
minimum, a covered entity's effective communication procedures must 
include the contact information for the Section 1557 Coordinator (if 
applicable); how an employee obtains the services of qualified 
interpreters the covered entity uses to communicate with individuals 
with disabilities; the names of any qualified interpreter staff 
members; and how to access appropriate auxiliary aids and services that 
are necessary for

[[Page 47850]]

effective communication. This provision is similarly consistent with 
the civil rights clearance process required for Medicare Part A 
providers, which requires policies and procedures to ensure effective 
communication for individuals with disabilities, including, where 
appropriate, the provision of auxiliary aids and services.\281\
---------------------------------------------------------------------------

    \281\ Technical Assistance for Medicare Providers and 
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil 
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/technical-assistance/index.html (last updated 
Oct. 27, 2021).
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    Proposed paragraph (f) requires covered entities to develop and 
implement written procedures for making reasonable modifications to 
their policies, practices, or procedures that allow individuals with 
disabilities equal opportunity to participate in their health programs 
and activities as required under proposed Sec.  92.205. As proposed, a 
covered entity's reasonable modification procedures must, at a minimum, 
include contact information for the covered entity's Section 1557 
Coordinator (if applicable); describe the covered entity's process for 
responding to requests from individuals with disabilities for changes, 
exceptions, or adjustments to a rule, policy, practice, or service of 
the covered entity; and the process for determining whether making the 
modification would fundamentally alter the nature of the service, 
program, or activity, including identifying an alternative modification 
that does not result in a fundamental alteration to ensure the 
individual with a disability receives the benefits or services in 
question.
    We note that the failure to request a reasonable modification does 
not always excuse the covered entity from providing a reasonable 
modification to avoid discrimination on the basis of disability, as 
long as it does not result in a fundamental alteration. For example, 
when a covered entity had knowledge of an individual's disability and 
needs, or when an individual's disability and needs are obvious, a 
covered entity must provide modifications in the absence of a 
request.\282\
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    \282\ See, e.g., Greer v. Richardson Indep. Sch. Dist., 472 F. 
App'x 287, 296 (5th Cir. 2012) (holding that a ``failure to 
expressly `request' an accommodation is not fatal to an ADA claim 
where the defendant otherwise had knowledge of the individual's 
disability and needs but took no action''); Duvall v. Cty. of 
Kitsap, 260 F.3d 1124, 1139 (9th Cir. 2001) (``When the plaintiff 
has alerted the public entity to his need for accommodation (or 
where the need for accommodation is obvious . . .), the public 
entity is on notice that an accommodation is required . . .'').
---------------------------------------------------------------------------

    Proposed paragraph (g) provides that a covered entity may combine 
the content of the policies and procedures required by this provision 
with any policies and procedures pursuant to other civil rights 
statutory protections if they clearly comply with Section 1557 and the 
provisions in this part.
    The Department encourages covered entities to include additional 
information in their Section 1557 Policies and Procedures to provide 
employees the means to ensure individuals are able to access their 
health programs and activities free from discrimination. For example, 
covered entities may consider including information in their respective 
Section 1557 Policies and Procedures regarding service animals, as well 
as maintaining civil rights protections during public health 
emergencies.
    We seek comment on this proposed provision and whether there may be 
alternative measures that the Department should consider to proactively 
prevent discrimination, and whether they would be more or less 
burdensome than what is proposed. We would particularly welcome 
comments from covered entities concerning their experiences under 
voluntary resolution agreements with OCR requiring them to adopt 
policies and procedures. We also invite comment from all covered 
entities that have previously implemented or are currently implementing 
a nondiscrimination policy, grievance procedures, language access 
procedures, effective communication procedures, or reasonable 
modification procedures; consumers who interact with covered health 
programs and activities; and community-based organizations that work 
with LEP individuals and individuals with disabilities. We also seek 
comment on whether covered entities employing less than 15 people 
should be required to have a grievance procedure, including the 
benefits for a less formal resolution process.

Training (Sec.  92.9)

    To ensure that covered entities implement Section 1557 Policies and 
Procedures in accordance with proposed Sec.  92.8, proposed Sec.  92.9 
requires covered entities to train relevant employees in their health 
programs and activities on their Section 1557 Policies and Procedures. 
This proposed section, coupled with Sec.  92.8, is designed to help 
covered entities and their employees take measures to prevent 
discrimination by ensuring that staff are knowledgeable about the 
nondiscrimination policy, grievance procedures, and processes by which 
to obtain language assistance services for LEP individuals and to 
ensure effective communication with and provide reasonable 
modifications for individuals with disabilities.
    Proposed paragraph (a) provides a general requirement that covered 
entities train relevant employees of their health programs and 
activities on the Section 1557 Policies and Procedures required by 
proposed Sec.  92.8. Given the diversity of entities covered by this 
part, the Department is not prescribing the specific training methods a 
covered entity must use or the nature of a covered entity's training 
program. The Department notes, however, that the more thoroughly a 
covered entity trains its staff on its Section 1557 Policies and 
Procedures, the more likely it is that the covered entity will 
successfully provide services to individuals in a nondiscriminatory 
manner and avoid potential liability for violations of Section 1557 and 
this part.
    Further, this provision takes into consideration potential burdens 
on covered entities by requiring that only relevant staff (including, 
but not limited to, the Section 1557 Coordinator, if applicable) be 
trained, rather than requiring all staff to be trained. The Department 
anticipates that relevant health program and activity staff will 
include those involved in client and patient interactions, as well as 
those involved with drafting, approving, and funding policies and 
procedures for compliance with this part. However, such aspects of 
training required by this section are left to the discretion of the 
covered entity. The proposed approach, which requires training only on 
the covered entity's Section 1557 Policies and Procedures, is 
efficient, provides practical benefits based on each covered entity's 
unique circumstances, and is less resource intensive than requiring 
covered entities to train relevant staff on all of the regulatory 
requirements for Section 1557's underlying statutes.
    Similar to the proposal to require Section 1557 Policies and 
Procedures, the Department believes in the importance of proactive 
measures to prevent and mitigate the potential for discriminatory 
conduct in covered health programs and activities. That is why the 
Department proposes to require training in this rulemaking. OCR 
provides public education and outreach and has found it to be an 
effective means to ensure covered entities are complying with their 
respective Federal civil rights obligations. Just as OCR's proactive 
public education and outreach efforts yield compliance benefits, based 
on the Department's enforcement and compliance assistance experience we 
believe that covered entities' proactive Section 1557 Policies and 
Procedures, coupled with employee training, will

[[Page 47851]]

yield compliance benefits as well as improved health outcomes.\283\
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    \283\ See, e.g., John S. Lord, Jr., Health Care Providers: It's 
Not Just Employee Discrimination Claims--Patients Can Have 
Discrimination Claims Too, Nat'l L. Rev. (Feb. 8, 2022) 
(recommending ``perioding compliance reviews and up-to-date 
trainings'' on civil rights nondiscrimination requirements to ``help 
prevent and defend'' against patient discrimination claims), https://www.natlawreview.com/article/health-care-providers-it-s-not-just-employee-discrimination-claims-patients-can-have.
---------------------------------------------------------------------------

    Federal agency technical assistance materials on language access 
consistently highlight the important role training plays in delivering 
services effectively. For example, CMS' ``Guide to Developing a 
Language Access Plan'' dedicates an entire section to advising 
organizations about the importance of training.\284\ The Guide 
provides, in part, that an organization's training should focus on the 
organizations' policies and procedures related to providing language 
assistance services. Similarly, a DOJ assessment and planning tool for 
federally conducted and federally assisted programs included ``training 
staff on policies and procedures'' as one of the key six steps for 
developing an effective language access policy.\285\ DOJ's tool 
provides that ``[t]raining should explain how staff can identify the 
language needs of an LEP individual, access and provide the necessary 
language assistance services, work with interpreters, request document 
translations, and track the use of language assistance services.'' 
\286\
---------------------------------------------------------------------------

    \284\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & 
Medicaid Servs., Guide to Developing a Language Access Plan, p. 9, 
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Language-Access-Plan-508.pdf.
    \285\ U.S. Dep't of Justice, Language Access Assessment and 
Planning Tool for Federally Conducted and Federally Assisted 
Programs, p. 6 (2011), https://www.lep.gov/sites/lep/files/resources/2011_Language_Access_Assessment_and_Planning_Tool.pdf.
    \286\ Id.
---------------------------------------------------------------------------

    The Department believes that a staff training requirement will 
increase the likelihood that covered entities are prepared to best meet 
the communication needs of LEP individuals and individuals with 
disabilities, avoiding potentially critical delays or denials of care. 
This is particularly salient as the nation addresses the COVID-19 
pandemic and works to prepare for future public health emergencies. As 
described above, the COVID-19 pandemic exposed barriers to accessing 
health care for historically marginalized populations, including 
challenges related to providing testing and vaccination services in a 
way that provides meaningful access to LEP individuals and is 
accessible to individuals with disabilities. For example, many covered 
entities required individuals to register on a website or through an 
online portal in order to obtain a COVID-19 test or vaccine. Websites 
and portals often failed to include non-English registration 
instructions,\287\ and some have been inaccessible to individuals with 
disabilities.\288\
---------------------------------------------------------------------------

    \287\ Joseph R. Fuchs et al., Older Adults with Limited English 
Proficiency Need Equitable COVID-19 Vaccine Access, 69 J. Am. 
Geriatr. Soc'y. 888, 889 (2021), https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17069; Rachana 
Pradham, `Press 1 for English': Vaccination Sign-Ups Prove Daunting 
for Speakers of Other Languages, Kaiser Health News (Mar. 23, 2021), 
https://khn.org/news/article/press-1-for-english-vaccination-sign-ups-prove-daunting-for-speakers-of-other-languages/.
    \288\ Press release, U.S. Dep't of Justice, Justice Department 
Secures Settlement with Rite Aid Corporation to Make Its Online 
Covid-19 Vaccine Portal Accessible to Individuals with Disabilities 
(Nov. 1, 2021), https://www.justice.gov/usao-mdpa/pr/justice-department-secures-settlement-rite-aid-corporation-make-its-online-covid-19; Press release, U.S. Dep't of Justice, Justice Department 
Secures Agreement with Hy-Vee Supermarket Chain to Make Online 
COVID-19 Vaccine Registration Accessible for People with 
Disabilities (Dec. 1, 2021), https://www.justice.gov/opa/pr/justice-department-secures-agreement-hy-vee-supermarket-chain-make-online-covid-19-vaccine; Lauren Weber & Hannah Recht, Covid Vaccine 
websites Violate Disability Laws, Create Inequity for the Blind, 
Kaiser Health News (Feb. 25, 2021), https://khn.org/news/article/covid-vaccine-websites-violate-disability-laws-create-inequity-for-the-blind/; Haley Messenger, Blind Americans Face Roadblocks Booking 
Online Vaccine Appointments, NBC News (Mar. 13, 2021, 6:02 a.m.), 
https://www.nbcnews.com/business/consumer/blind-americans-face-roadblocks-booking-online-vaccine-appointments-n1260954; Fixing the 
Problem of Inaccessible Information from the Beginning, Equidox, 
https://equidox.co/blog/fixing-the-problem-of-inaccessible-covid-19-information/ (last visited June 15, 2022); Elise Young, Vaccine 
Rollout Leaves Behind the Blind, Paralyzed, Autistic, Bloomberg 
(Mar. 18, 2021, 10:25 a.m.), https://www.bloomberg.com/news/articles/2021-03-18/disabled-citizens-left-behind-in-u-s-push-to-overcome-pandemic; Maggie Vaughn, Vaccine Registration websites: 
Inaccessible to the Blind, Dubbot: DubBlog (Mar. 10, 2021), https://dubbot.com/dubblog/2021/vaccine-registration-websites-inaccessibile-to-the-blind.html.
---------------------------------------------------------------------------

    We have previously noted that, when necessary, OCR enters into 
voluntary resolution agreements with covered entities to resolve 
concerns about noncompliance with Federal civil rights laws, including 
Section 1557.\289\ These voluntary resolution agreements routinely 
require covered entities to develop policies and procedures and provide 
employee training on their policies and procedures because such actions 
promote compliance with Federal civil rights laws. OCR believes that 
the development and implementation of, and training on, such policies 
are likely to reduce discriminatory actions from occurring in the 
future and reduce the need for voluntary resolution agreements.
---------------------------------------------------------------------------

    \289\ See Recent Civil Rights Resolution Agreements & Compliance 
Reviews, U.S. Dep't of Health & Human Servs., Office for Civil 
Rights, https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/agreements/index.html (last updated June 15, 2022); see 
also supra note 271.
---------------------------------------------------------------------------

    Proposed paragraph (a) provides a general requirement that covered 
entities train relevant employees of their health programs and 
activities on the civil rights policies and procedures required by 
proposed Sec.  92.8.
    Proposed paragraph (b) specifies when covered entities must train 
relevant employees on their Section 1557 Policies and Procedures. We 
consider relevant employees to be those who directly encounter or 
interact with individuals such as patients, clients, and members of the 
public. Employees are also considered relevant when they make decisions 
regarding the services individuals seek from a covered entity's health 
programs and activities. Under paragraph (b)(1) covered entities would 
be required to train existing relevant employees on their Section 1557 
Policies and Procedures as soon as practicable, but no later than one 
(1) year after the effective date of the Final Rule. Proposed paragraph 
(b)(2) proposes that covered entities train new relevant employees 
within a reasonable period of time after they join a covered entity's 
workforce.
    In paragraph (b)(3), we propose to require covered entities to 
train relevant employees whose roles are affected by material changes 
to the covered entity's Section 1557 Policies and Procedures. Examples 
of material changes may include new contact information for a covered 
entity's Section 1557 Coordinator (if applicable), changing from one 
qualified interpreter service provider to another, acquiring or 
discontinuing the use of certain auxiliary aids and services, such as 
in response to changing technology, or substantive changes to the 
covered entity's process for ensuring effective communication or for 
providing language assistance services. Similar to paragraph (b)(2), 
paragraph (b)(3) would require covered entities to train employees 
within a reasonable time after a material change has been made. Nothing 
in the proposed provision prohibits covered entities from training 
their employees on Section 1557 Policies and Procedures more 
frequently. For example, covered entities may include such training in 
the existing annual or quarterly training programs that they require 
their employees to complete.
    Proposed paragraph (c) requires covered entities to 
contemporaneously document their employees' completion of the training 
required by this section

[[Page 47852]]

in written or electronic form and maintain said documentation for no 
less than three (3) calendar years.
    We note that neither the 2016 Rule nor the 2020 Rule included a 
training requirement, though we are aware that many covered entities 
already have civil rights trainings for their employees that could be 
modified to comply with this proposed provision. We seek comment on the 
experiences of covered entities in implementing training such as that 
required by proposed Sec.  92.9, examples of where training made a 
difference in compliance, the timing of required training, whether 
covered entities would like the flexibility to include this required 
training as part of its existing annual compliance training, what types 
of changes would constitute a material change such that a covered 
entity would need to retrain staff, and the amount of time for which 
training records must be retained. We also seek general comment on this 
proposal, including the effectiveness of civil rights training 
programs, the benefits experienced by covered entity staff and the 
people they serve, as well as the costs associated with the proposed 
training requirements.
    We further seek comment on whether the Section 1557 Policies and 
Procedures requirements and training requirements may increase the 
likelihood of compliance with the substantive legal requirements of 
Section 1557.

Notice of Nondiscrimination (Sec.  92.10)

    Proposed Sec.  92.10 requires each covered entity to provide a 
notice of nondiscrimination, relating to its health programs and 
activities, to participants, beneficiaries, enrollees, and applicants 
of its health programs and activities, and members of the public. 
Notice can be provided through written translations or in-language 
recorded audio or video clips.
    The 2016 Rule required covered entities to include a 
nondiscrimination notice and set of taglines (i.e., a short non-English 
statement in appropriate languages indicating the availability of 
language assistance services) in all ``significant publications or 
significant communications . . . which may include patient handbooks, 
outreach publications, or written notices pertaining to rights or 
benefits or requiring a response from an individual'' in conspicuous 
physical locations and online.\290\ The 2016 Rule included a separate 
provision for ``small-sized'' significant publications 
communications.\291\ This provision required covered entities to 
include a notice statement in lieu of the full notice, on small-sized 
significant publications and significant communications like postcards 
and tri-fold brochures.\292\
---------------------------------------------------------------------------

    \290\ 81 FR 31375, 31396 (May 18, 2016).
    \291\ Former 45 CFR 92.8(g)(1).
    \292\ Id.
---------------------------------------------------------------------------

    The 2016 Rule received criticism for failing to provide a 
definition of ``significant publications or significant 
communications,'' though it provided some examples of what would be 
considered ``significant.'' The Department also received substantial 
feedback regarding the financial burden imposed by the notice and 
tagline requirements. Citing these concerns, the 2020 Rule repealed the 
2016 Rule's provisions on notices and taglines in their entirety.\293\
---------------------------------------------------------------------------

    \293\ 85 FR 37160, 37161, 37176, 37228 (June 19, 2020).
---------------------------------------------------------------------------

    The Department has reviewed concerns raised in response to the 2016 
Rule requirements, as well as those raised in response to the removal 
of the notice and tagline requirements in the 2020 Rule. Although we 
acknowledge the additional responsibilities placed on covered entities 
through the 2016 Rule requirements, we believe that the 2020 Rule does 
not adequately consider some of the adverse consequences that 
individuals incur or the burdens that the health care system faces 
without these notice provisions.\294\ Therefore, the Department has 
concluded that it should not have eliminated these provisions in their 
entirety. To ensure clarity and reduce confusion, this proposed rule 
will address the notice of nondiscrimination and notice of availability 
of language assistance services and auxiliary aids and services in 
separate sections.
---------------------------------------------------------------------------

    \294\ See, e.g., Nat'l Council of Asian Pacific Ams., Comment on 
Section 1557 NPRM, pp. 3-7 (Aug. 13, 2019), https://www.regulations.gov/comment/HHS-OCR-2019-0007-145953.
---------------------------------------------------------------------------

    Proposed Sec.  92.10(a) requires covered entities to provide a 
notice of nondiscrimination, relating to their health programs and 
activities, to participants, beneficiaries, enrollees, and applicants 
of their health programs and activities, and to members of the public. 
Proposed paragraph (a)(1) provides the required contents of the notice 
of nondiscrimination, including that (i) the covered entity does not 
discriminate on the basis of race, color, national origin (including 
limited English proficiency and primary language), sex (including 
pregnancy, sexual orientation, gender identity, or sex 
characteristics), age, or disability in its health programs or 
activities; (ii) the covered entity provides reasonable modifications 
for individuals with disabilities, and appropriate auxiliary aids and 
services, including qualified interpreters, for individuals with 
disabilities and information in alternate formats, such as braille or 
large print, free of charge and in a timely manner, when such 
modifications or aids and services are necessary to ensure 
accessibility and equal opportunity to participate to individuals with 
disabilities; (iii) the covered entity provides language assistance 
services, including electronic and written translated documents and 
oral interpretation free of charge and in a timely manner, when such 
services are necessary to provide meaningful access to a limited 
English proficient individual; (iv) how to obtain from the covered 
entity the reasonable modifications, auxiliary aids and services, and 
language assistance services in paragraphs (a)(1)(ii) and (iii) of this 
section; (v) the contact information for the covered entity's Section 
1557 Coordinator designated pursuant to Sec.  92.7 of this part (if 
applicable); (vi) the availability of the covered entity's grievance 
procedure pursuant to Sec.  92.8(c) of this part and how to file a 
grievance (if applicable); (vii) details on how to file a 
discrimination complaint with HHS' Office for Civil Rights; and (viii) 
how to access the covered entity's website, if it has one, that 
provides the information required under paragraph (a)(1) of this 
section. OCR is proposing to require a parenthetical for national 
origin discrimination, to include limited English proficiency and 
primary language, to clarify for the public that these are prohibited 
forms of discrimination. For the same reason, a parenthetical would be 
required for sex discrimination, to include pregnancy, sexual 
orientation, gender identity, or sex characteristics.
    Proposed Sec.  92.10(a)(2) would provide specific information on 
when and where covered entities must provide the notice of 
nondiscrimination. Rather than requiring entities to include the notice 
in ``significant'' communications, we propose that covered entities 
provide the notice on an annual basis and upon request. Similar to the 
2016 Rule requirements, we propose that the notice also be placed at a 
conspicuous location on the covered entity's health program or activity 
website,\295\ if it has

[[Page 47853]]

one, and in clear and prominent physical locations where it is 
reasonable to expect individuals seeking service from the health 
program or activity to be able to read or hear the notice. These 
requirements would pose a relatively low-cost burden for covered 
entities while ensuring information regarding the covered entity's 
civil rights obligations is provided in locations that are highly 
visible and visited by participants and members of the public.
---------------------------------------------------------------------------

    \295\ For more information about improving access to public 
websites for LEP individuals, see U.S. Dep't of Justice, Title VI 
Interagency Working Group, Improving Access to Public websites and 
Digital Services for Limited English Proficient (LEP) Persons (Dec. 
2021), https://www.lep.gov/sites/lep/files/media/document/2021-12/2021_12_07_website_Language_Access_Guide_508.pdf.
---------------------------------------------------------------------------

    Paragraph (b) proposes that a covered entity may combine the 
content of the notice required by paragraph (a) of this section with 
the notices required by Title VI, Section 504, Title IX, and the Age 
Act implementing regulations \296\ if the combined notice clearly 
informs individuals of their civil rights under Section 1557 and this 
part and meets the requirements outlined in proposed paragraph (a)(1).
---------------------------------------------------------------------------

    \296\ 45 CFR 80.6(d) (Title VI); Sec.  84.8 (Section 504, 
federally assisted); Sec.  85.12 (federally conducted); Sec.  86.9 
(Title IX); Sec.  91.32 (Age Act).
---------------------------------------------------------------------------

    In drafting these proposed notice provisions, the Department 
considered alternative approaches such as requiring covered entities to 
provide notices at every encounter with a participant or beneficiary or 
simply adopting the approach in the 2016 Rule. The Department decided 
against these approaches, and believes the proposed provisions 
emphasize the importance of notifying individuals of their civil rights 
and makes clear the requirements for notifying individuals about 
important civil rights requirements. Further, we believe this proposal 
addresses the burdens raised by covered entities in response to the 
2016 Rule notice requirements by providing specific occurrences (annual 
basis and upon request) and locations (conspicuous location on website 
and prominent physical location) for when and where the notice must be 
provided rather than the ambiguity caused by the 2016 Rule.
    We seek comment on whether the notice of nondiscrimination 
requirement as proposed is practical, likely to be effective, and 
responsive to concerns raised regarding the 2016 and 2020 Rules, 
including the sufficiency of the content of the notice and requirements 
regarding when and where covered entities must provide the notice. In 
particular, we seek comment on the best ways to provide an accessible 
initial notice to individuals who may require auxiliary aids and 
services for their disabilities and the best way in which to provide 
the notice in a manner accessible to LEP individuals. The Department is 
also interested in hearing from covered entities regarding whether they 
are still following the 2016 notice requirement, and the potential 
burdens and costs of what is proposed here.

Notice of Availability of Language Assistance Services and Auxiliary 
Aids and Services (Sec.  92.11)

    Proposed Sec.  92.11 requires covered entities to notify the public 
of the availability of language assistance services and auxiliary aids 
and services for their health programs and activities (``Notice of 
Availability''). This provision is similar to the ``tagline'' 
requirement found at former Sec.  92.8 in the 2016 Rule, but with 
additional information required to be included in the notice. The 2016 
Rule required covered entities to provide ``taglines,'' short 
statements written in non-English languages that indicate the 
availability of language assistance services free of charge, in a 
variety of languages and communications.\297\ The Department has opted 
not to use the term ``tagline'' in this rule because this provision 
also now requires a notice of the availability of auxiliary aids and 
services.
---------------------------------------------------------------------------

    \297\ Former 45 CFR 92.8.
---------------------------------------------------------------------------

    The 2016 Rule required covered entities to include ``taglines'' in 
at least the top 15 languages spoken by LEP individuals in the relevant 
state or states in significant publications and communications and at 
various locations.\298\ To reduce the administrative burden on covered 
entities, OCR translated these statements into 64 languages and made 
the translated statements available to covered entities.\299\
---------------------------------------------------------------------------

    \298\ Id. Sec.  92.8(d)(1).
    \299\ 81 FR 31453.
---------------------------------------------------------------------------

    The 2020 Rule repealed this provision, citing costs, confusion, and 
waste, but stated that covered entities are still required ``to provide 
taglines whenever such taglines are necessary to ensure meaningful 
access by LEP individuals to a covered program or activity.'' \300\ 
Commenters argued the 2019 NPRM's Regulatory Impact Analysis (RIA) 
labeled the impact on LEP individuals of eliminating notice and tagline 
requirements as negligible without providing an evidentiary basis \301\ 
and failed to address the costs beneficiaries would face without these 
provisions and the additional costs to the health care system that 
could result.\302\ We now believe that in finalizing the 2020 Rule 
absent any ``tagline'' requirement, the Department did not adequately 
weigh the concerns raised by commenters, including the costs 
individuals incur or the burdens the health care system would face 
without these requirements.\303\
---------------------------------------------------------------------------

    \300\ See 85 FR 37160, 37176, 37228, 37241 (June 19, 2020).
    \301\ See id. at 37204.
    \302\ See Nat'l Council of Asian Pacific Ams., supra note 294, 
at pp. 3-7; see also 85 FR 37233.
    \303\ See supra note 302.
---------------------------------------------------------------------------

    Commenters specifically argued that eliminating ``tagline'' 
provisions would result in fewer safeguards that minimize health care 
risks LEP individuals face in the health care system, including 
avoidable hospital readmissions, lower rates of outpatient follow up, 
limited use of preventive services, poor medication adherence, and lack 
of understanding discharge instructions.\304\ According to commenters, 
these impacts could lead to higher costs to the health care system, as 
LEP individuals are more likely to experience medical errors due to 
communication barriers. The availability of language assistance 
services, on the other hand, is associated with fewer readmission rates 
and fewer malpractice claims.\305\
---------------------------------------------------------------------------

    \304\ See Nat'l Women's Law Ctr., Comment on Section 1557 NPRM, 
p. 21 (Aug. 13, 2019), https://www.regulations.gov/comment/HHS-OCR-2019-0007-149018.
    \305\ See Nat'l P'ship for Women & Families, Comment on Section 
1557 NPRM, p. 16 (Aug. 13, 2019) (citing to Quan K. Lynch, Nat'l 
Health Law Program, The High Costs of Language Barriers in Medical 
Malpractice, p. 18 (2010)), https://www.regulations.gov/comment/HHS-OCR-2019-0007-137897.
---------------------------------------------------------------------------

    Several organizations have sued the Department for repealing the 
notice and tagline provisions of the 2016 Rule. The lawsuits detail the 
costs of repealing these requirements. In the Whitman-Walker case, the 
plaintiffs, organizations providing and advocating for health care 
services, and individual health care professionals, alleged that the 
removed provisions are critical to ensuring meaningful access to 
care.\306\ The plaintiffs further argued that removing the 2016 Rule's 
tagline provisions, ``burden[s] private health care and individual 
provider plaintiffs, as well as members of health professional 
association plaintiffs, because patients will come to them sicker due 
to inadequate care elsewhere, and more people may come to them because 
their LEP services will remain robust.'' \307\ The plaintiffs also 
alleged that eliminating the notice provisions would make it more 
difficult for patients ``to understand their health care rights, 
communicate with doctors and other health care workers, and navigate 
complex insurance and medical

[[Page 47854]]

documents with specialized terminology, and cause an increase in 
patients who will delay or not seek care at all.'' \308\ In Chinatown 
Services Center v. U.S. Department of Health & Human Services, the 
plaintiffs, community-based organizations that serve older LEP adults, 
similarly alleged that elimination of the notice and tagline 
requirements of the 2016 Rule undermines access to health care, and 
that the elimination was arbitrary and capricious because HHS did not 
consider alternatives to repealing these protections.\309\ The 
Chinatown Service Center plaintiffs alleged the 2020 Rule fails to 
adequately consider the confusion caused by the removal of taglines, 
the impact of the rule change on access to care and treatment, 
individuals' reliance on taglines, and frustration with difficulty 
accessing health care.\310\ The complaint alleges that ``without notice 
of their rights, LEP older adults remain in the dark as to their right 
to free interpreter services at a medical appointment or what they can 
do when providers wrongly require LEP individuals to rely on 
unqualified informal or family-member interpreters.'' \311\
---------------------------------------------------------------------------

    \306\ Whitman-Walker Compl., supra note 205, at p. 67-68.
    \307\ Id. at p. 68.
    \308\ Id. at p. 28.
    \309\ Compl., Chinatown Serv. Ctr. v. U.S. Dep't of Health & 
Human Servs., No. 1:21-cv-00331, pp. 23, 35 (D.D.C. Feb. 5, 2021), 
ECF No. 1 [hereinafter Chinatown Serv. Ctr. Compl.].
    \310\ Id. at p. 21.
    \311\ Id. at p. 2.
---------------------------------------------------------------------------

    The Department has also heard from covered entities that they are 
committed to providing LEP individuals with language assistance 
services but recommend that the Department require covered entities to 
provide language assistance services in a manner that does not 
overwhelm enrollees with redundant paperwork that may be unnecessary, 
repetitive, or wasteful.\312\
---------------------------------------------------------------------------

    \312\ AHIP Recommendations for 1557 Notice and Tagline 
Requirements, p. 1 (Nov. 1, 2021). The document will be attached to 
the docket of this proposed rule as a supplemental material at 
federalregister.gov.
---------------------------------------------------------------------------

    After considering concerns raised through litigation, stakeholder 
feedback, and language access complaints OCR continues to receive, we 
have determined that the 2020 Rule's approach in eliminating these 
provisions in their entirety is unnecessary and counterproductive. We 
believe that the benefits of meaningful access to LEP individuals, 
through notice of the availability of language access services, 
outweigh the costs of implementing the changes set forth in this NPRM. 
The 2020 Rule creates uncertainty and confusion concerning when 
language assistance services must be provided, resulting in higher risk 
for covered entities while rendering Section 1557 less effective at 
combatting discrimination experienced by LEP individuals. The 
Department believes that the provisions set forth in this NPRM would 
help restore consistency in language assistance procedural requirements 
and provide certainty to covered entities and consumers about what 
covered entities' obligations are and what rights consumers have.
    The proposed reinstatement of in-language notices is also intended 
to help alleviate burdens on covered entities who primarily serve LEP 
populations. LEP individuals often rely on community-based 
organizations as the first line of support when they are unable to 
access other systems due to language barriers. While we recognize that 
this reported increase coincides with the COVID-19 pandemic, we also 
believe it highlights the importance now, more than ever, of providing 
notice of the availability of language assistance services in health 
programs and activities. Additionally, we believe having these services 
in place now will help covered entities be better prepared to serve LEP 
individuals during any future public health emergencies that may arise.
    In addition, several commenters to the 2019 NPRM indicated that 
removing the 2016 Rule's tagline provisions would contribute to health 
disparities. For example, the National Women's Law Center referenced a 
2018 poll, which said approximately 6 in 10 Latino adults reported 
having trouble communicating with their providers due to language or 
cultural barriers.\313\ As a result, the poll reported that Spanish-
speaking LEP individuals are more likely to report experiencing worse 
health outcomes than Latino individuals who are monolingual in English 
or bilingual in English and Spanish.\314\ Although the 2020 Rule 
removed the requirement that covered entities include ``taglines'' in 
the top 15 languages spoken by LEP individuals in their state, it 
maintained the requirement that covered entities provide taglines 
whenever such taglines are necessary to ensure meaningful access by LEP 
individuals to a covered health program or activity. Yet the 2020 Rule 
provides limited guidance to covered entities and consumers on what 
covered entities' obligations are and what consumers' rights are. 
Covered entities remain without clear guidance as to when in-language 
taglines must be included to help LEP individuals understand that 
language services are available and how to access them. OCR continues 
to receive language access complaints that raise concerns about 
entities not providing sufficient taglines. The proposed ``Notice of 
Availability'' requirement, analogous to the 2016 Rule ``tagline'' 
requirement, removes existing ambiguity for covered entities and would 
result in increased access to health programs and activities for LEP 
individuals.
---------------------------------------------------------------------------

    \313\ Nat'l Women's Law Ctr., supra note 304, at p. 21.
    \314\ Id.
---------------------------------------------------------------------------

    While the 2020 Rule preamble raised concerns about cost and waste, 
we believe it failed to strike the right balance by eliminating these 
important provisions altogether given the considerations discussed 
above. With proposed Sec.  92.11, we seek to be responsive to industry 
concerns regarding excessive costs and other potential burdens to 
covered entities, while balancing the importance of providing LEP 
individuals notice of the availability of language assistance services 
to eliminate barriers to accessing quality health care. In this new 
provision, we also propose to require the Notice of Availability to 
include a statement regarding the availability of appropriate auxiliary 
aids and services to reduce barriers to access for individuals with 
disabilities.
    Proposed paragraph (a) requires a covered entity to provide a 
notice that, at minimum, states that the covered entity provides 
language assistance services and appropriate auxiliary aids and 
services free of charge in its health programs and activities, when 
necessary for compliance with Section 1557 or this part. This notice 
must be provided to participants, beneficiaries, enrollees, and 
applicants of the covered entity's health program or activity, and 
members of the public. Notice can be provided through written 
translations or recorded audio or video clips.
    Proposed paragraph (b) requires the Notice of Availability to be 
provided in English and at least the 15 most common languages spoken by 
LEP individuals of the relevant state or states, and in alternate 
formats for individuals with disabilities who request auxiliary aids 
and services to ensure effective communications. This standard ensures 
that a significant proportion of each state's particular LEP population 
is receiving key information in the appropriate language. While the 
standard of providing the statement in these ``top 15'' languages is 
the same as that required by the 2016 Rule, we attempt to alleviate 
burdens here by proposing a list of the relevant materials in which the 
Notice of Availability must be included and providing options for 
covered entities to allow individuals to ``opt out'' of receipt of the 
Notice of

[[Page 47855]]

Availability or to provide communication to individuals in their 
primary language in lieu of a Notice of Availability. As in 2016, OCR 
will provide a sample Notice of Availability for covered entities to 
use, as well as the 15 most common non-English languages spoken by LEP 
individuals for each state and territory.
    The Department considered including a population threshold after 
consulting the Department of Agriculture's Supplemental Food and 
Nutrition regulation, which includes requirements prescribed by the 
Food Stamp Act \315\ to translate materials in non-English 
languages.\316\ The Department declines to include the adoption of a 
population threshold because of the inconsistent results that would 
result in notice requirements for urban and rural communities.\317\ The 
Department also considered requiring translation of the Notice of 
Availability in the ``top 15'' languages to the extent that there are 
at least 200 LEP speakers for a particular language in the relevant 
state or states. This standard would require fewer language 
translations for states such as Montana (notices in only 11 languages) 
and Wyoming (notices in only 4 languages). However, we declined to 
institute this alternative so as to not include an arbitrary cut-off, 
such as 200 LEP speakers, into the proposed regulation, and instead 
provided covered entities alternatives to the requirement to provide a 
Notice of Availability. We seek comment on this approach.
---------------------------------------------------------------------------

    \315\ 7 U.S.C. 2020(e)(1)(B).
    \316\ 7 CFR 272.4(b)(2); see also 65 FR 70143-44 (Nov. 21, 2000) 
(discussing access to households with language access barriers).
    \317\ See 43 FR 47846, 47849 (Oct. 17, 1978) (``Although many 
commenters suggested adoption of a uniform percentage test, the 
Department rejected that concept because it could require bilingual 
service in sparsely populated areas where only two or three 
households are of a single language minority. Conversely, in densely 
populated low-income areas, hundreds of single-language areas and 
hundreds of single-language minority households could be an 
insufficient number to meet the percentage test required for 
bilingual services.'').
---------------------------------------------------------------------------

    Proposed Sec.  92.11(c) requires the notice be provided on an 
annual basis to participants, beneficiaries, enrollees (including late 
and special enrollees), and applicants, and upon request at any time. 
Similar to the notice of nondiscrimination requirement in proposed 
Sec.  92.10, the Notice of Availability would also be required to be 
provided at a conspicuous location on the covered entity's health 
program or activity website, if it has one, and in clear and prominent 
physical locations where it is reasonable to expect individuals seeking 
service from the health program or activity to be able to read or hear 
the notice. This notice must also be accessible to individuals with 
disabilities who require auxiliary aids and services. These 
requirements would pose a relatively low-cost burden for covered 
entities and ensure information about language assistance services is 
provided in locations that are highly visible and visited by members of 
the public.
    In response to concerns raised by stakeholders regarding the lack 
of specificity in the term ``significant publications or significant 
communications,'' rather than providing a general class of documents 
for which the notice must be provided (e.g., ``significant 
documents''), we propose in paragraph (c)(5) to provide a list of 
specific electronic and written communications that must be accompanied 
by the Notice of Availability. After consideration, we believe this 
approach is more tailored to the needs of LEP individuals and 
individuals with disabilities when accessing important information 
regarding a range of health programs and activities and provides the 
level of specificity sought by covered entities.
    We propose to require the Notice of Availability to accompany the 
following documents: (i) the notice of nondiscrimination required by 
proposed Sec.  92.10 of this part; (ii) the notice of privacy practices 
required by the implementing regulations for the Health Insurance 
Portability and Accountability Act of 1996 \318\ (HIPAA) at 45 CFR 
164.520; (iii) application and intake forms; (iv) notices of denial or 
termination of eligibility, benefits, or services, including 
Explanations of Benefits (EOBs), and notices of appeal and grievance 
rights; (v) communications related to a person's rights, eligibility, 
benefits, or services that require or request a response from a 
participant, beneficiary, enrollee, or applicant; (vi) communications 
related to a public health emergency; (vii) consent forms and 
instructions related to medical procedures or operations, medical power 
of attorney, or living will (with an option of providing only one 
notice for all documents bundled together); (viii) discharge papers; 
(ix) complaint forms; and (x) patient and member handbooks.
---------------------------------------------------------------------------

    \318\ Public Law 104-191, 100 Stat. 2548 (1996).
---------------------------------------------------------------------------

    We considered limiting the requirement to include the notice of 
availability of language assistance services and auxiliary aids in EOBs 
to only those EOBs that notify individuals of a cost-sharing 
responsibility. In other words, an EOB showing that services have been 
fully covered and that the patient has no further financial 
responsibility for the service (including co-payment, co-insurance, 
disallowed cost for which a provider may bill the patient, or other 
charge) would not constitute a notice of a denial or termination of 
benefits or services, and therefore would not be required to include 
the notice of availability. However, we determined that the burden of 
administering a process to assess which EOBs fall under the requirement 
and then include the notice only to those EOBs would be more burdensome 
than the alternative of including the notice in all EOBs. We invite 
comment as to whether this is the most appropriate approach, balancing 
the burden of providing notices of availability with all EOBs against 
the burdens associated with determining which EOBs must include the 
notice.
    To further alleviate the potential burdens of subsection (d), we 
propose alternative, optional methods by which a covered entity may be 
deemed in compliance with proposed Sec.  92.11(a). First, pursuant to 
proposed paragraph (d)(1), a covered entity shall be deemed in 
compliance with respect to an individual if the covered entity, on an 
annual basis: provides individuals, in their primary language and 
through any appropriate auxiliary aids and services, the option to opt 
out of receipt of the Notice of Availability; does not condition 
receipt of any aid or service on the decision to opt out; informs the 
individual of their right to receive the notice upon request in their 
primary language and through any appropriate auxiliary aids and 
services, and that opting out of receiving the notice is not a waiver 
of their right to receive language assistance services and any 
appropriate auxiliary aids and services as required by this part in 
their primary language and through any appropriate auxiliary aid or 
service; documents, on an annual basis, the individual's decision to 
opt out; and does not treat a non-response from an individual as a 
decision to opt out. Second, proposed paragraph (d)(2) provides that a 
covered entity shall be deemed in compliance with this section with 
respect to an individual if the covered entity documents the 
individual's primary language and any appropriate auxiliary aids and 
services and either provides all materials and communications in that 
individual's primary language and through any appropriate auxiliary 
aids and services, or provides the notice required by Sec.  92.11(a) in 
that individual's primary language and through any appropriate 
auxiliary aids

[[Page 47856]]

and services in all communications that are identified in Sec.  
92.11(c)(5).
    In drafting these proposed provisions, the Department considered 
alternative approaches, such as requiring covered entities to provide 
the Notice of Availability at every interaction with a participant or 
beneficiary, or simply adopting the approach in the 2016 Rule. However, 
the unnecessary duplication of requiring covered entities to provide a 
Notice of Availability at every interaction with a beneficiary 
outweighs any potential benefit, and simply adopting the approach in 
the 2016 Rule would not address confusion regarding covered entities' 
legal obligations related to the term ``significant documents'' or 
concerns expressed about financial burden. We also considered an opt-in 
approach whereby covered entities would offer individuals an 
opportunity to opt in to receiving a copy of a covered entity's Notice 
of Availability. However, given the varying nature of Section 1557 
covered entities, it would be difficult to specify when covered 
entities must offer individuals the opportunity to opt in to receiving 
its Notice of Availability. More importantly, we believe that the 
information contained in the proposed Notice of Availability is 
indispensable to the receipt of services free from discrimination. 
Accordingly, by providing an opt-out option, proposed Sec.  92.11 
attempts to balance the potential financial burden on covered entities 
of providing the Notice of Availability against the essential need for 
individuals to understand their rights and therefore would limit the 
burden without jeopardizing individual access to information.
    The Department believes the approach in this proposed rule 
emphasizes the importance of notifying individuals of their civil 
rights and makes clear the requirements for notifying individuals about 
important civil rights requirements. The Department also believes the 
proposed rule addresses concerns raised by covered entities in response 
to the 2016 Rule requirements.
    We seek comment on whether the Notice of Availability requirement 
as proposed is practical and responsive to concerns raised regarding 
the 2016 and 2020 Rules, including the sufficiency of the content of 
the Notice of Availability and requirements on when and where covered 
entities must provide the notice. We also seek comment as to whether it 
adequately addresses the specific concerns raised regarding the burdens 
associated with the 2016 Rule requirements by providing a list of 
specific documents with which the Notice of Availability must be 
provided. Additionally, we seek comment on how to best provide the 
Notice of Availability to individuals with disabilities to ensure they 
know how to request and receive relevant materials and documents in 
formats that meet their disability-related needs, and whether covered 
entities should be required to provide the Notice of Availability in 
sign language. Similarly, we seek comment on how to best provide the 
Notice of Availability to LEP individuals, including LEP individuals 
with disabilities, to ensure they know how to request and receive 
language assistance services and auxiliary aids and services to provide 
meaningful access to relevant materials and documents. We also seek 
comment on whether the list of communications proposed adequately 
captures the documents for which LEP individuals and individuals with 
disabilities should receive the Notice of Availability. We further seek 
comment on the anticipated costs to covered entities of various sizes 
to comply with the proposed requirements.

Data Collection

    Commenters on the 2015 NPRM requested that OCR require covered 
entities to collect additional data, beyond those required by the 
referenced statutes and their regulations, on race, ethnicity, 
language, sex, gender, gender identity, sexual orientation, disability, 
and age, in part so that such entities could better plan how to meet 
the needs of those populations.\319\ We considered including a 
provision in the rule requiring covered entities to collect additional 
civil rights data given the vital role data can play in ensuring civil 
rights compliance and the fact that such data remain largely 
uncollected for many demographic subgroups. At this time, however, we 
are not including such a provision but are soliciting feedback and 
comments on such data collection to inform a final rule and OCR's 
overall civil rights work.
---------------------------------------------------------------------------

    \319\ 81 FR 31375, 31392-93 (May 18, 2016).
---------------------------------------------------------------------------

    The COVID-19 pandemic serves as an example of the importance of 
access to data collection in addressing harm at the earliest possible 
stages of a public health emergency in order to provide effective and 
lifesaving health care. In the early days of the COVID-19 pandemic, 
public health officials lacked the data necessary to gain a full 
picture of how the pandemic was impacting marginalized communities, 
prompting the publication of tools like the COVID Racial Data Tracker. 
The COVID Racial Data Tracker was created out of a collaboration 
between the COVID Tracking Project and the Boston University Center for 
Antiracist Research to gather racial and ethnic demographic data to 
understand the outbreak of COVID-19 and protect vulnerable 
communities.\320\ Indeed, as the COVID-19 pandemic has highlighted, the 
lack of demographic data can make it challenging to determine where 
public health disparities are occurring and where to allocate resources 
such as COVID-19 testing and vaccinations.\321\ These issues have civil 
rights implications. Just as nearly all of the provisions in this 
proposed rule benefit Section 1557 covered entities as much as they 
benefit the public, a data collection provision has the potential to 
benefit state and local health departments because they would be able 
to use the data they collect to reveal existing health disparities and 
proactively allocate and disseminate the resources necessary to address 
public health disparities.
---------------------------------------------------------------------------

    \320\ About the Racial Data Tracker, covidtracking.com, https://covidtracking.com/race/about (last visited June 15, 2022).
    \321\ See Tom Simonite, Covid Hits Minorities Hardest, But Data 
Often Doesn't Show It, Wired Business (Aug. 24, 2020, 7:00 a.m.), 
https://www.wired.com/story/covid-hits-minorities-hardest-data-doesnt-show/; Laura Barron-Lopez et al., Missing Data Veils 
Coronavirus Damage to Minority Communities, Politico (June 14, 2020, 
7:00 a.m.), https://www.politico.com/news/2020/06/14/missing-data-veils-coronavirus-damage-to-minority-communities-316198.
---------------------------------------------------------------------------

    Since the beginning of the COVID-19 pandemic, the Federal 
Government has responded with several data collection resources--which 
can be used by Federal, State, territorial, and local governments 
alike--to provide a clearer picture of how COVID-19 is impacting 
communities across the country. Executive Order 13985, ``Advancing 
Racial Equity and Support for Underserved Communities Through the 
Federal Government,'' established the Interagency Working Group on 
Equitable Data with the goal of collecting more disaggregated data 
across Federal agencies to be better equipped to measure and advance 
equity through the work of every Federal agency.\322\ Data that the 
Federal Government has recently made available can continue to be used 
to reveal and address long-existing health disparities. Some examples 
of health data the Federal Government is collecting include those in 
HHS' Protect Public Data Hub,\323\ which is a secure data ecosystem for 
sharing, parsing, housing, and accessing COVID-19 data; CDC data

[[Page 47857]]

on COVID-19 cases and deaths by state or territory; \324\ those in the 
HealthData.gov COVID-19 Reported Patient Impact and Hospital Capacity 
by State Timeseries, which provides state-aggregated data for hospital 
utilization in a timeseries format; \325\ and those in the 
HealthData.gov COVID-19 Diagnostic Laboratory Testing Time Series, 
which reports COVID-19 test results from over 1,000 U.S. laboratories 
and testing locations, including commercial and reference laboratories, 
public health laboratories, and other testing locations.\326\ This is 
not an exhaustive list of the Federal Government's data collection 
activities, but merely identifies some examples of what has changed 
since the beginning of the COVID-19 pandemic.
---------------------------------------------------------------------------

    \322\ 86 FR 7009 (Jan. 25, 2021).
    \323\ HHS Protect Public Data Hub, https://protect-public.hhs.gov/ (last June 15, 2022).
    \324\ United States COVID-19 Cases and Deaths by State over 
Time, data.cdc.gov, https://data.cdc.gov/Case-Surveillance/United-States-COVID-19-Cases-and-Deaths-by-State-o/9mfq-cb36 (last updated 
June 15, 2022).
    \325\ COVID-19 Reported Patient Impact and Hospital Capacity by 
State Timeseries, HealthData.gov, https://healthdata.gov/Hospital/COVID-19-Reported-Patient-Impact-and-Hospital-Capa/g62h-syeh (last 
updated June 15, 2022).
    \326\ COVID-19 Diagnostic Laboratory Testing (PCR Testing) Time 
Series, HealthData.gov, https://healthdata.gov/dataset/COVID-19-Diagnostic-Laboratory-Testing-PCR-Testing/j8mb-icvb (last updated 
June 15, 2022).
---------------------------------------------------------------------------

    When considering adding a data collection provision to this 
proposed rule, the Department contemplated what kind of additional data 
we might require covered entities to collect and from which covered 
entities the Department should collect such data. In addition to race, 
ethnicity, language, age, and disability, we considered requiring 
covered entities to collect data on sex, gender, gender identity, and 
sexual orientation from patients and health care providers. Some states 
and territories, including California and Washington, DC, currently 
require plans sold on their Health Insurance Exchanges to collect 
demographic data about enrollees' race and ethnicity, but not sexual 
orientation or gender identity.\327\ In Colorado, a new state law will 
require issuers to offer a standardized ``Colorado Option'' plan on the 
State Exchange in 2023, which includes a requirement to offer a 
culturally responsive network of providers.\328\ Additionally, the 
state's law requires issuers to attempt to collect demographic data, 
including race, ethnicity, disability status, sex, sexual orientation, 
and gender identity from their providers and the providers' front 
office staff.\329\ The Department understands there may be concerns 
related to requiring covered entities to collect deeply personal data. 
On one hand, the access to such data can provide a clearer picture of 
disparities and gaps in patient outcomes and representation in the 
provision of care. On the other hand, some providers and patients are 
hesitant to provide data on their race, sexual orientation, or gender 
identity for fear of discrimination.\330\ The Department recognizes the 
challenges associated with requiring covered entities to collect such 
data.
---------------------------------------------------------------------------

    \327\ Markian Hawryluk, Some Physicians Are Uneasy as Colorado 
Collects Providers' Diversity Data, npr.org (April 25, 2022, 5:00 
a.m.), https://www.npr.org/sections/health-shots/2022/04/25/1094354537/colorado-doctor-diversity-data.
    \328\ Id.
    \329\ Id.
    \330\ Id.
---------------------------------------------------------------------------

    The Department believes that rather than codifying a specific set 
of data collection measures within this rulemaking, the Department--
through OCR--is better positioned to create a dynamic and responsive 
civil rights data collection structure by using its existing 
authorities. OCR does have the authority to request compliance data 
from covered entities under its existing civil rights authorities, 
which we propose to codify for purposes of Section 1557 at proposed 
Sec.  92.303(a) (incorporating by reference 45 CFR 80.6 with regard to 
recipients and State Exchanges) and proposed Sec.  92.303(c) (with 
regard to the Department and Federally-facilitated Exchanges). Using 
our existing authorities would be similar to the Department of 
Education (ED)'s civil rights data collection process. Since 1968, ED's 
Office for Civil Rights has, without a regulatory standard for a 
recurring civil rights data collection, required its elementary and 
secondary education recipients to collect data \331\ on the leading 
civil rights data indicators related to access and barriers to an 
educational opportunity from early childhood through 12th grade, 
disaggregated by race/ethnicity, sex, disability, and English Learner 
status.\332\ By using existing authorities, the Department believes OCR 
will have the flexibility to be responsive to the critical health-
related civil rights issues that may arise in the future.
---------------------------------------------------------------------------

    \331\ ED's current authority to collect data comes from section 
203(c)(1) of the Department of Education Organization Act (20 U.S.C. 
3413(c)(1)) and is informed by the regulations implementing several 
of the civil rights statutes that it implements authorizing 
collection of data that are necessary to ensure compliance with 
civil rights laws within the jurisdiction of ED's OCR.
    \332\ 20 U.S.C. 3413(c)(1). See also 34 CFR 100.6(b), Sec.  
104.61, Sec.  106.71; Civil Rights Data Collection: Frequently Asked 
Questions, U.S. Dep't of Educ., Office for Civil Rights, https://www2.ed.gov/about/offices/list/ocr/frontpage/faq/crdc.html (last 
modified Apr. 14, 2021).
---------------------------------------------------------------------------

    We seek comment on this general approach, including whether covered 
entities are already collecting disaggregated demographic data in their 
health programs and activities and, if so, for which categories of 
data, through what systems, and at what cost. We also seek comment on 
how a civil rights data collection requirement could impact current 
data collection efforts, either positively or negatively. We also seek 
comment on whether the adoption of a regulatory standard for a 
recurring civil rights data collection would benefit civil rights 
enforcement, as well as how frequently the data should be submitted to 
OCR. We also seek comment on whether the data collection requirements 
should vary by type of entity, as recipients of Federal financial 
assistance include a variety of entities, including state and local 
agencies, health insurance issuers, health care providers, health care 
facilities and clinics, hospitals, federally qualified health centers, 
and health-related educational and training programs. Accordingly, we 
seek comment on which types of recipients (if any) should be covered; 
if recipients under a certain size should be exempt from the data 
collection requirement, and if so, should that be based on employee 
number, the number of beds (if relevant), or some other metric; what 
types of data should be collected; what definitions should be used; the 
potential costs associated with such a requirement; and the potential 
benefits of such a requirement.

Subpart B--Nondiscrimination Provisions

    For the reasons described below, Subpart B of the proposed rule 
generally adopts certain regulatory provisions regarding specific 
discriminatory actions prohibited by the implementing civil rights 
statutes referenced in Section 1557(a): Title VI, Section 504, Title 
IX, and the Age Act.

Discrimination Prohibited (Sec.  92.101)

    Proposed Sec.  92.101(a) provides a general prohibition of 
discrimination on the basis of race, color, national origin, sex, age, 
or disability under any health program or activity to which Section 
1557 or this part applies and provides additional detail regarding what 
constitutes discrimination on the basis of sex. Proposed paragraph (b) 
identifies some specific forms of prohibited discrimination.
    Proposed paragraph (a)(1) provides the general prohibitions on 
discrimination under Section 1557 by restating the core objective of 
Section 1557: ensuring that covered entities do not discriminate on the 
basis of race, color, national origin, sex, age, or disability against 
any individual seeking

[[Page 47858]]

to participate in or receive the benefits of the covered entity's 
health program or activity. Consistent with Federal case law \333\ and 
existing Federal civil rights enforcement,\334\ the Department's 
proposed nondiscrimination protections prohibit discrimination based 
upon a person's actual or perceived race, color, national origin, sex, 
age, or disability.
---------------------------------------------------------------------------

    \333\ See Fogleman v. Mercy Hosp., 283 F.3d 561, 572 (3d Cir. 
2002) (employee of hospital employer may pursue retaliation claim 
even if employer's perception that employee was Muslim is factually 
incorrect); EEOC v. WC&M Enters., 496 F.3d 393, 400-01 (5th Cir. 
2007) (national origin harassment of an Indian Muslim employee 
included harassment based on the employer's perception that he was 
an Arab Muslim); Glenn v. Brumby, 663 F.3d 1312, 1319 (11th Cir. 
2011) (``An individual cannot be punished because of his or her 
perceived gender-nonconformity.'') (emphasis added); Jones v. UPS 
Ground Freight, 683 F.3d 1283 (11th Cir. 2012) (employer may still 
be liable for harasser's use of epithets associated with an ethnic 
or racial minority different than that of the plaintiff employee); 
Estate of Lance v. Lewisville Indep. Sch. Dist., 743 F.3d 982, 991 
(5th Cir. 2014) (``. . . [section] 504's reach extends not only to 
individuals who in fact have a disability, but also to individuals 
who are regarded as having a disability (whether or not that 
perception is correct)''); but cf. El v. Max Daetwyler Corp., 451 F. 
App'x 257 (4th Cir. 2011) (per curiam opinion affirmed district 
court's order granting employer's motion to dismiss because Title 
VII does not ``contain an explicit provision for the protection of 
persons who are merely perceived to be a part of a protected 
class'').
    \334\ See U.S. Equal Emp't Opportunity Comm'n, EEOC Enforcement 
Guidance on National Origin Discrimination, n.16 (Nov. 18, 2016), 
https://www.eeoc.gov/laws/guidance/national-origin-guidance.cfm#ftn16 (Title VII prohibits employer actions that have 
the purpose or effect of discriminating against persons because of 
their real or perceived race, national origin, or association with a 
particular religion) (emphasis added); Housing Discrimination and 
Persons Identified as Lesbian, Gay, Bisexual, Transgender, and/or 
Queer/Questioning (LGBTQ), U.S. Dep't of Hous. & Urban Dev., https://www.hud.gov/program_offices/fair_housing_equal_opp/housing_discrimination_and_persons_identifying_lgbtq (last updated 
Feb. 1, 2022) (``Persons who identify as LGBTQ and believe they have 
experienced housing discrimination because of their actual or 
perceived sexual orientation or gender identity can assert their 
rights under the Fair Housing Act by filing a complaint with HUD.'') 
(emphasis added); Race and National Origin Discrimination Frequently 
Asked Questions, U.S. Dep't of Educ., https://www2.ed.gov/about/offices/list/ocr/frontpage/faq/race-origin.html (last modified Jan. 
1, 2020) (``Discrimination on the basis of race, color, national 
origin includes discrimination based on a person's actual or 
perceived race, color, national origin, ethnicity, or ancestry.'') 
(emphasis added).
---------------------------------------------------------------------------

    Proposed paragraph (a)(2) clarifies that discrimination on the 
basis of sex includes discrimination on the basis of sex stereotypes; 
sex characteristics, including intersex traits; pregnancy or related 
conditions; sexual orientation; and gender identity.
    The proposed inclusion of ``sex stereotypes'' codifies the Supreme 
Court's holding in Price Waterhouse v. Hopkins that discrimination on 
the basis of sex stereotypes is a form of sex discrimination.\335\ As 
the Court there explained, ``we are beyond the day when an employer 
could evaluate employees by assuming or insisting that they matched the 
stereotype associated with their group,'' for ``[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.'' \336\ The 
Supreme Court reiterated this principle in Bostock, explaining that 
``an employer who fires both [a woman] and [a man] for failing to 
fulfill traditional sex stereotypes doubles rather than eliminates 
Title VII liability.'' \337\
---------------------------------------------------------------------------

    \335\ 490 U.S. 228, 250-51 (1989).
    \336\ Id.; cf. U.S. v. Virginia, 518 U.S. 515, 533 (1996) (in 
making classifications based on sex, states ``must not rely on 
overboard generalizations about the different talents, capacities, 
or preferences of males and females'').
    \337\ Bostock v. Clayton Cty., 140 S. Ct. 1731, 1742-43 (2020).
---------------------------------------------------------------------------

    We are proposing to include ``sex characteristics'' because 
discrimination based on anatomical or physiological sex characteristics 
(such as genitals, gonads, chromosomes, hormone function, and brain 
development/anatomy) is inherently sex-based. Discrimination on the 
basis of intersex traits is similarly prohibited sex discrimination 
because the individual is being discriminated against based on their 
sex characteristics. If their sex characteristics were different--i.e., 
traditionally ``male'' or ``female''--the intersex person would be 
treated differently. Moreover, like gender identity and sexual 
orientation, intersex traits are ``inextricably bound up with'' 
sex,\338\ and ``cannot be stated without referencing sex.'' \339\ The 
DOJ has similarly concluded that Bostock's reasoning applies to 
discrimination based upon intersex traits.\340\
---------------------------------------------------------------------------

    \338\ Id. at 1742.
    \339\ Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d 586, 608 (4th 
Cir. 2020) (quoting Whitaker v. Kenosha Unified Sch. Dist. No. 1 Bd. 
of Educ., 858 F.3d 1034, 1051 (7th Cir. 2017)).
    \340\ See Memorandum from Kristen Clarke, Assistant Att'y Gen., 
Civil Rights Div., U.S. Dep't of Justice, to Dep't of Justice Office 
of Justice Programs, Office of Cmty. Oriented Policing Servs., 
Office on Violence Against Women, & Money Laundering & Asset 
Recovery Section, 2 (Mar. 10, 2022), https://www.justice.gov/crt/page/file/1481776/download; U.S. Dep't of Justice, Title IX Legal 
Manual, Title IX Cover Addendum post-Bostock (updated Aug. 12, 
2021), https://www.justice.gov/crt/title-ix#Bostock.
---------------------------------------------------------------------------

    The proposed inclusion of ``pregnancy or related conditions'' is 
consistent with the longstanding interpretation of sex discrimination 
under Title IX, including the Department's Title IX implementing 
regulation.\341\
---------------------------------------------------------------------------

    \341\ See Conley v. Northwest Fla. State Coll., 145 F. Supp. 3d 
1073 (N.D. Fla. 2015). See also 45 CFR 86.21(c)(2), (3); Sec.  
86.40(b)(1), (4), (5); Sec.  86.51(b)(6); Sec.  86.57(b)(d) (Title 
IX regulation).
---------------------------------------------------------------------------

    The proposed inclusion of ``sexual orientation'' and ``gender 
identity'' is consistent with the Supreme Court's reasoning in Bostock. 
As explained in the Department's Bostock Notification, the Court's 
reasoning applies to Title IX and, by extension, to Section 1557.\342\ 
Given the similarity in nondiscrimination language between Title VII 
and Title IX, most Federal courts \343\ that have addressed the issue, 
and the Departments of Justice and Education, have interpreted Title IX 
consistent with Bostock's reasoning.\344\
---------------------------------------------------------------------------

    \342\ 86 FR 27984 (May 25, 2021).
    \343\ Doe v. Snyder, No. 21-15668, 2022 WL 711420, at *9 (9th 
Cir. Mar. 10, 2022); Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d at 
616; Koenke v. Saint Joseph's Univ., No. 19-cv-4731, 2021 WL 75778, 
at *2 (E.D. Pa. Jan. 8, 2021); Doe v. Univ. of Scranton, No. 3:19-
cv-01486, 2020 WL 5993766, at *11 n.61 (M.D. Pa. Oct. 9, 2020); but 
see Neese v. Becerra, No. 2:21-cv-00163-Z, 2022 WL 1265925, at *14 
(N.D. Tex. Apr. 26, 2022) (denying motion to dismiss, finding ``at 
this stage of litigation, the approved tools of textualism do not 
support'' application of Bostock to ``Title IX--and by extension 
Section 1557'').
    \344\ Karlan Memo, supra note 46; 86 FR 32637 (June 22, 2021) 
(Department of Education).
---------------------------------------------------------------------------

    The Franciscan Alliance court concluded that the 2016 Rule's 
definition of ``sex'' as including ``gender identity'' was contrary to 
Section 1557 because ``Title IX and Congress' incorporation of it in 
[Section 1557 of] the ACA unambiguously adopted the binary definition 
of sex.'' \345\ The Department disagrees. In Bostock, the Supreme Court 
held that the prohibition on discrimination ``because of . . . sex'' 
under Title VII covers discrimination on the basis of gender identity 
and sexual orientation even assuming that ``sex'' refers ``only to 
biological distinctions between male and female.'' \346\ Title IX and 
Section 1557 prohibit discrimination ``on the basis of sex.'' \347\ 
Because their statutory prohibitions against sex discrimination are 
similar, the Supreme Court and other Federal courts consistently look 
to interpretations of Title VII to inform Title IX.\348\ Thus, 
Bostock's discussion of the text of Title VII informs the Department's 
analysis of Title IX and Section 1557.
---------------------------------------------------------------------------

    \345\ Franciscan All., Inc. v. Burwell, 227 F. Supp. 3d 660, 689 
(N.D. Tex. 2016).
    \346\ 140 S. Ct. at 1744.
    \347\ 20 U.S.C. 1681(a); 42 U.S.C. 18116.
    \348\ See, e.g., Franklin v. Gwinnett Cty. Pub. Sch., 503 U.S. 
60, 75 (1992); Jennings v. Univ. of N.C., 482 F.3d 686, 695 (4th 
Cir. 2007); Gossett v. Oklahoma ex rel. Bd. of Regents for Langston 
Univ., 245 F.3d 1172, 1176 (10th Cir. 2001).
---------------------------------------------------------------------------

    First, like Title VII, Title IX and Section 1557 apply to sex 
discrimination against an individual. Title VII states that it is 
unlawful for an

[[Page 47859]]

employer ``to fail or refuse to hire or to discharge any individual, or 
otherwise to discriminate against any individual'' regarding their 
``compensation, terms, conditions, or privileges of employment, because 
of such individual's race, color, religion, sex, or national origin.'' 
\349\ The Bostock Court focused on this feature of Title VII in 
reaching its holding.\350\ Similarly, Title IX states that ``no person 
in the United States shall, on the basis of sex, be excluded from 
participation in, be denied the benefits of, or be subjected to 
discrimination under any education program or activity receiving 
Federal financial assistance.'' \351\ Furthermore, Section 1557 
provides that ``an individual shall not, on the ground prohibited 
[under Title VI, Title IX, the Age Act, or Section 504] 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.'' \352\
---------------------------------------------------------------------------

    \349\ 42 U.S.C. 2000e-2(a)(1) (emphasis added).
    \350\ Bostock, 140 S. Ct. at 1740-41 (``[The statute] tells us 
three times--including immediately after the words ``discriminate 
against''--that our focus should be on individuals.'').
    \351\ 20 U.S.C. 1681(a) (emphasis added).
    \352\ 42 U.S.C. 18116 (emphasis added).
---------------------------------------------------------------------------

    Second, Title IX's ``on the basis of'' sex language is sufficiently 
similar to ``because of'' sex under Title VII as to be considered 
interchangeable. In Bostock itself, the Supreme Court described Title 
VII's language that way: ``[I]n Title VII, Congress outlawed 
discrimination in the workplace on the basis of race, color, religion, 
sex, or national origin.'' \353\ The Bostock Court concluded that Title 
VII's prohibition of discrimination ``because of'' sex includes 
discrimination because of sexual orientation and transgender status, 
finding that when an employer discriminates against employees for being 
gay or transgender, ``the employer must intentionally discriminate 
against individual men and women in part because of sex.'' \354\ 
Indeed, the Court clearly held that it is ``impossible to discriminate 
against a person'' for being gay or transgender ``without 
discriminating against that individual on the basis of sex.'' \355\
---------------------------------------------------------------------------

    \353\ Bostock, 140 S. Ct. at 1737; see also Meritor Sav. Bank, 
FSB v. Vinson, 477 U.S. 57, 64 (1986) (``[W]hen a supervisor 
sexually harasses a subordinate because of the subordinate's sex, 
that supervisor `discriminate[s]' on the basis of sex.'') (emphasis 
added).
    \354\ Bostock, 140 S. Ct. at 1740-43.
    \355\ Id. at 1741.
---------------------------------------------------------------------------

    The same reasoning in Bostock supports the interpretation that 
Title IX's prohibition of discrimination ``on the basis of'' sex, and, 
relatedly, that Section 1557's prohibition on discrimination ``on the 
ground prohibited under Title IX'' prohibits covered entities from 
discriminating against an individual based on that person's sexual 
orientation or transgender status. After considering the text of Title 
IX and Section 1557, Supreme Court case law, and developing 
jurisprudence in this area, the Department has determined that the best 
reading of Title IX's prohibition on discrimination ``on the basis of 
sex'' and Section 1557's prohibition on discrimination ``on the ground 
prohibited under Title IX'' is that it includes discrimination on the 
basis of gender identity and sexual orientation. Should there be any 
ambiguity read into the statutory text of Title IX or Section 1557 with 
regard to this issue, the Department would nonetheless adopt this 
interpretation given the statutory objectives of the civil rights 
statutes and the importance of ensuring that individuals are able to 
receive health care free from discrimination.
    Proposed paragraph (b) identifies several specific forms of 
prohibited discrimination under Section 1557. It does so by 
incorporating by reference the specific prohibitions on discrimination 
in the regulations implementing each civil rights statute referenced in 
Section 1557's statutory text. Even though Section 1557 provides an 
independent basis for the regulation of discrimination in covered 
programs and activities, this proposed section expressly adopts the 
specific prohibitions on discrimination found in the implementing 
regulations of the referenced antidiscrimination statutes. We believe 
this approach is appropriate in light of Section 1557's express 
adoption of the same language used in the four referenced statutes to 
describe the nature of the prohibited conduct--namely, causing an 
individual to ``be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under'' a specified 
program or activity. Incorporating by reference the regulations that 
have long described certain forms of such conduct under those specified 
statutes is consistent with the ACA and provides clarity, while not 
including redundant text in this rule. The text proposes to direct the 
reader to the ``prohibitions on discrimination'' in sections of the 
Title VI, Section 504, Title IX (subparts C and D), and Age Act 
(subpart B) regulations. This is similar to the approach taken in the 
2016 Rule but, rather than citing specific provisions, we propose a 
general reference.
    Though the 2020 Rule purported to clarify covered entities' Section 
1557 obligations, it sought to do so through general statements. The 
2020 Rule, at Sec.  92.2, generally provides the nondiscrimination 
requirements of Section 1557 by restating the statutory language of 42 
U.S.C. 18116(a), followed by stating that the grounds prohibited are 
the grounds found in the Title VI, Title IX, Section 504, and Age Act 
statutes. This approach has caused confusion by eliminating guidance as 
to certain specific discriminatory actions that one generally finds in 
an implementing regulation for a civil rights statute. The Department 
believes it is helpful for covered entities and protected individuals 
to have additional clarity regarding some common, specific prohibitions 
under Section 1557.
    We believe the proposed approach is the most reasonable reading of 
Section 1557's direction that ``an individual shall not . . . 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, or under any program or 
activity that is administered by an Executive Agency or any entity 
established under this title (or amendments).'' \356\ Because this 
language is adapted from the four referenced statutes, it is reasonable 
and appropriate to look to those statutes' implementing regulations to 
further clarify what it means to discriminate on the grounds prohibited 
by those statutes. Rather than restating each of the specific 
prohibitions on discrimination under each implementing regulation, we 
propose that Sec.  92.101(b) simply cross-reference the implementing 
regulations of these referenced civil rights statutes. Note that this 
proposed rule does not in any way limit or impact the interpretation of 
those statutes.
---------------------------------------------------------------------------

    \356\ 42 U.S.C. 18116(a).
---------------------------------------------------------------------------

    Proposed paragraph (b)(1)(i) specifically refers to recipients of 
Federal financial assistance and State Exchanges; proposed paragraph 
(b)(1)(ii) refers to the Department's health programs and activities, 
including Federally-facilitated Exchanges. Under both of these 
paragraphs, covered entities would be prohibited from the 
discriminatory actions found in the applicable sections of the Title 
VI, Title IX, and Age Act implementing regulations, found at 45 CFR 
parts 80, 86 (subparts C and D), and 91 (subpart B), respectively. For 
the specific discriminatory actions provided for in Section 504 
implementing regulation, recipients and State Exchanges will look

[[Page 47860]]

to the implementing regulation at 45 CFR part 84 (federally funded), 
and the Department will look to the implementing regulation at 45 CFR 
part 85 (federally conducted).
    Proposed paragraph (b)(2) provides that the enumeration of specific 
forms of discrimination in paragraph (b) of this section does not limit 
the general application of the prohibition in proposed paragraph (a) of 
this section. Although some of these provisions would articulate 
specific forms of prohibited discrimination that have not otherwise 
been articulated under some of the underlying statutes referenced in 
Section 1557, these provisions are included to ensure parity across all 
prohibited bases of discrimination under Section 1557 with regard to 
covered entities' health programs and activities.
    The 2016 Rule included, at former Sec.  92.101(b)(3)(ii) and (iii), 
provisions specifically related to prohibited discrimination on the 
basis of sex related to criteria and methods of administration and 
selection of facility sites and locations that have the effect of 
discriminating on the basis of sex or the purpose or effect of 
defeating or substantially impairing the accomplishment of the 
objectives of the program or activity on the basis of sex. The 2020 
Rule removed these paragraphs. The 2016 Rule language is similar to 
language found in the implementing regulations for Title VI, Section 
504, and the Age Act.\357\ The Department has determined not to include 
a similar provision here as the Department believes it is important to 
preserve--and not expand--the longstanding treatment of disparate 
impact in the referenced statutes' implementing regulations. We seek 
comment on this approach, including whether a provision similar to that 
included in the 2016 Rule is necessary, and whether it should be 
limited to discrimination on the basis of sex, or should also include 
each of the enumerated grounds covered under Section 1557's statutory 
prohibition on discrimination.
---------------------------------------------------------------------------

    \357\ 45 CFR 80.3(b)(2), (3) (Title VI); Sec.  84.4(b)(4), (5) 
(Section 504); Sec.  90.12.(b) (Age Act).
---------------------------------------------------------------------------

Subpart C--Specific Applications to Health Programs and Activities

    Because of Section 1557's unique application to health programs and 
activities, Subpart C provides additional specificity regarding 
nondiscrimination requirements in this setting. The provisions in this 
subpart are responsive to the nature and importance of health care, 
health insurance, and related decision-making as it impacts individuals 
and communities protected by Section 1557's prohibition of 
discrimination. These provisions are intended to provide clear 
instruction to covered entities and are informed by OCR's stakeholder 
outreach and experience in both enforcement and in providing technical 
assistance.

Meaningful Access for Limited English Proficient Individuals (Sec.  
92.201)

    Proposed Sec.  92.201 effectuates Section 1557's prohibition on 
national origin discrimination as it is applied to LEP individuals in 
covered health programs and activities. For LEP individuals, the lack 
of proficiency in English and the use of non-English languages is often 
tied to their national origin. It is well-established that an entity 
may violate Title VI and its implementing regulation by failing to take 
reasonable steps to provide meaningful access to LEP individuals.\358\ 
The provision of free and effective language assistance services to LEP 
individuals is essential to ensure compliance with nondiscrimination 
laws.
---------------------------------------------------------------------------

    \358\ See, e.g., Lau v. Nichols, 414 U.S. 563, 566 (1974) 
(interpreting Title VI and its implementing regulations to require a 
school district with students of Chinese origin with limited English 
proficiency to take affirmative steps to provide the students with a 
meaningful opportunity to participate in federally funded 
educational programs); Dep't of Health, Educ., & Welfare, 
Identification of Discrimination and Denial of Services on the Basis 
of National Origin, 35 FR 11595 (July 18, 1970); E.O. 13166, 
Improving Access to Services. for Persons with Limited English 
Proficiency, 65 FR 50121 (Aug. 16, 2000) (directing Federal agencies 
that extend assistance subject to the requirements of Title VI to 
publish guidance for their respective recipients clarifying the 
obligation to provide language services to LEP individuals); Dep't 
of Justice, Guidance to Federal Financial Assistance Recipients 
Regarding Title VI Prohibition Against National Origin 
Discrimination Affecting Limited English Proficient Persons, 67 FR 
41455, 41457 (June 18, 2002); Dep't of Educ., Office for Civil 
Rights & Dep't of Justice, Civil Rights Div., Dear Colleague Letter: 
English Learner Students and Limited English Proficient Parents 
(Jan. 7, 2015), https://www2.ed.gov/about/offices/list/ocr/letters/colleague-el-201501.pdf.
---------------------------------------------------------------------------

    Proposed paragraph (a) provides that covered entities ``must take 
reasonable steps to provide meaningful access to each limited English 
proficient individual eligible to be served or likely to be directly 
affected by its health programs and activities.'' This language is 
nearly identical to the 2016 Rule at former Sec.  92.201(a), which 
required a covered entity to take reasonable steps to provide 
meaningful access to each LEP individual ``eligible to be served or 
likely to be encountered.'' \359\ The Department is proposing to revise 
this language slightly to include individuals likely to be ``directly 
affected'' rather than ``encountered.'' This language is consistent 
with the 2003 HHS LEP Guidance \360\ and OCR resolution 
agreements,\361\ and we believe this language provides more clarity for 
covered entities regarding the individuals for whom reasonable steps 
must be taken. As the Department has advised in the past, ordinarily, 
persons eligible to be served or likely to be directly affected by a 
recipient's program are those persons who are in the covered entity's 
service area, and who either are eligible for the covered entity's 
benefits or services, or otherwise might be directly affected by such 
an entity's conduct. For example, a parent seeking health services for 
a child would be seen as directly affected by a covered entity's 
policies and practices.\362\
---------------------------------------------------------------------------

    \359\ Former 45 CFR 92.201(a).
    \360\ 68 FR 47311, 47314 (Aug. 8, 2003).
    \361\ See, e.g., Voluntary Resolution Agreement between U.S. 
Dep't Health & Human Servs., Office for Civil Rights & Pa. Dep't of 
Human Servs. (2019), https://www.hhs.gov/sites/default/files/hhs-padhs-vra.pdf.
    \362\ See, e.g., 65 FR 52762, 51767-68 (Aug. 30, 2000).
---------------------------------------------------------------------------

    The language of the 2020 Rule differs from the 2016 Rule in that it 
requires reasonable steps to ensure meaningful access ``to programs or 
activities by limited English proficient individuals,'' rather than 
``each'' LEP individual.\363\ The preamble to the 2020 Rule explains 
this change by arguing that the 2016 Rule's ``stringent requirement . . 
. could potentially be interpreted to require a covered entity to 
provide language assistance services to every LEP individual it comes 
into contact with.'' \364\ The plain language of the 2016 Rule in fact 
required that covered entities must take reasonable steps to provide 
meaningful access to each individual with limited English proficiency 
eligible to be served or likely to be encountered in its health 
programs and activities.\365\ For example, a surgeon would likely 
determine that it is a reasonable step to provide an interpreter when 
discussing the risks and aftercare of a particular procedure with an 
LEP individual in order to afford that individual meaningful access; 
however, a hospital may determine that reasonable access can be 
provided via sight translation of a generic brochure for an LEP patient 
rather than providing a fully translated version. This standard does 
not impose a significant burden on covered entities, as it does not 
mandate that every LEP individual receive language services,

[[Page 47861]]

but rather that covered entities at a minimum conduct a reasonable 
steps evaluation for each LEP individual. However, the Department notes 
that, as the availability of telephonic interpreters increases, the 
evaluation of the reasonableness of providing language services shifts.
---------------------------------------------------------------------------

    \363\ 85 FR 37160, 37245 (June 19, 2020); 45 CFR 92.101(a).
    \364\ 85 FR 37210.
    \365\ 81 FR 31375, 31470 (May 18, 2016).
---------------------------------------------------------------------------

    Taking reasonable steps to assess and meet the needs of each LEP 
individual eligible to be served or likely to be directly affected by 
the covered entity's health program or activity is important to ensure 
compliance with both Title VI and Section 1557. The need for a case-by-
case determination is particularly important in the area of health 
care. As noted in the preamble to the 2016 Rule,

    [S]afe and quality health care requires an exchange of 
information between the health care provider and patient for the 
purposes of diagnoses, treatment options, the proper use of 
medications, obtaining informed consent, and insurance coverage of 
health-related services, among other purposes. This exchange of 
information is jeopardized when the provider and the patient speak 
different languages and may result in adverse health consequences 
and even death. Indeed, the provision of health care services, by 
its `very nature[,] requires the establishment of a close 
relationship with the client or patient that is based on sympathy, 
confidence and mutual trust,' which cannot be established without 
effective communication.\366\
---------------------------------------------------------------------------

    \366\ Id. at 31413.

    Ensuring accurate, timely, and high-quality communication within 
the health care context is particularly important to LEP individuals 
and their families, who can be put in danger by not understanding a 
physician or other health care provider and the health protocols those 
individuals may prescribe. For example, an LEP parent or guardian may 
leave a doctor's office misunderstanding how to properly care for their 
child, putting the well-being of the child at risk due to 
miscommunication between the parent or guardian and the doctor 
regarding the health details of the child. Vigorous communication 
standards are extremely important in helping to minimize the health 
care risks LEP people face in the health care system, including lower 
rates of outpatient follow up, poor medication adherence, and a lack of 
understanding of diagnosis and discharge instructions.\367\ Nothing has 
changed in this regard since the publication of the 2016 Rule; rather, 
the COVID-19 pandemic has demonstrated how critical meaningful access 
to health programs and activities is for the health and well-being of 
LEP individuals. A recent study documented the unique challenges faced 
by LEP individuals during the COVID-19 pandemic. The authors explained 
that factors like under-interpretation of complex conversations, non-
universal use of interpreters, fewer conversations throughout the day 
with staff, not receiving important medical paperwork in their native 
language, and being separated from social support networks that often 
assist with the navigation of health care systems exacerbated these 
challenges for LEP individuals under the social isolation of inpatient 
care settings during the strict COVID-19 no visitation policies.\368\
---------------------------------------------------------------------------

    \367\ U.S. Dep't Health & Human Servs., Ctrs. for Medicare & 
Medicaid Servs., Guide to Preventing Readmissions Among Racially and 
Ethnically Diverse Medicare Beneficiaries, p. 4 (Sept. 2015), 
https://essentialhospitals.org/wp-content/uploads/2016/01/OMH_Readmissions_Guide.pdf.
    \368\ Natale K. Kucirek et al., Stories from COVID-19 Reveal 
Hospitalized Patients with Limited English Proficiency Have Always 
Been Uniquely Prone to Social Isolation, 36 J. of General Internal 
Med. 786, 789 (2021), https://doi.org/10.1007/s11606-020-06383-z.
---------------------------------------------------------------------------

    Proposed paragraph (b) states that language assistance services 
required under paragraph (a) must be provided free of charge, be 
accurate and timely, and protect the privacy and independent decision-
making ability of an LEP individual. This provision is similar to those 
included in the 2016 Rule at former Sec.  92.201(c) and the 2020 Rule 
at Sec.  92.101(b)(2) and is consistent with longstanding Title VI 
requirements and the HHS LEP Guidance.\369\ The Department reminds 
states that they have the option to claim Medicaid reimbursement for 
the cost of interpretation services, either as medical-assistance or 
administration related expenditures.\370\
---------------------------------------------------------------------------

    \369\ 68 FR 47316.
    \370\ See Translation and Interpretation Services, Ctrs. for 
Medicare & Medicaid Servs., https://www.medicaid.gov/medicaid/financial-management/medicaid-administrative-claiming/translation-and-interpretation-services/index.html (last visited June 15, 2022).
---------------------------------------------------------------------------

    Proposed paragraph (c) provides specific requirements for 
interpreter and translation services. Proposed paragraph (c)(1) states 
that when interpreter services are required under this part, a covered 
entity must offer a qualified interpreter. Proposed paragraph (c)(2) 
provides that when translation services are required under this part, a 
covered entity must use a qualified translator. These terms are defined 
in the definitions section at proposed Sec.  92.4.
    Proposed paragraph (c)(3) addresses the use of machine translation 
by covered entities. Machine translation, which can involve speech-
based machine translation to facilitate patient-provider communication 
as well as text-based machine translation to develop multilingual 
health materials, is increasingly being used as a method to assist 
communication in the health care setting and increase access to in-
language health resources.\371\ While the technology behind machine 
translation has improved in accuracy, the possibilities of significant 
consequences from inaccurate translation continue to exist.\372\ During 
the COVID-19 pandemic, several states and some territories received 
complaints from LEP individuals because they were unable to sign up for 
COVID-19 vaccines on websites using machine translation or found 
translated information confusing because of inaccuracies in some 
translations.\373\ The prevalence of inaccuracies was highlighted in a 
recent literature review of articles discussing machine translation in 
the health care context, which found that no matter the language or 
form of machine translation, all studies indicated error rates so high 
as to be ``unacceptable for actual deployment in health settings.'' 
\374\
---------------------------------------------------------------------------

    \371\ Kristin N. Dew et al., Development of Machine Translation 
Technology for Assisting Health Communication: A Systematic Review, 
85 J. of Biomedical Informatics 56, 57 (2018), https://reader.elsevier.com/reader/sd/pii/S1532046418301448?token=D92E78CBB86826ADC483479DED4B8E8442AE77630BCCB53F5385AE5AD2452E7FFC803B8CBA43AC533A509E3F977291BC&originRegion=us-east-1&originCreation=20220615184038.
    \372\ See Wenxiu Xie et al., Predicting Risks of Machine 
Translations of Public Health Resources by Developing Interpretable 
Machine Learning Classifiers, 18 Int. J. Environ. Res. Pub. Health 
8789 (2021), https://www.mdpi.com/1660-4601/18/16/8789/htm; Lucas N. 
Vieira et al., Understanding the Societal Impacts of Machine 
Translation: A Critical Review of the Literature on Medical and 
Legal Use Cases, 24 Info., Comm., & Soc'y 1515 (2020), https://www.tandfonline.com/doi/full/10.1080/1369118X.2020.1776370; Nicole 
Wetsman, Google Translate Still Isn't Good Enough for Medical 
Instructions, The Verge (Mar. 9, 2021), https://www.theverge.com/2021/3/9/22319225/google-translate-medical-instructions-unreliable; 
Breena R. Taira et al., A Pragmatic Assessment of Google Translate 
for Emergency Department Instructions, 36 J. Gen. Intern. Med. 3361 
(2021), https://link.springer.com/article/10.1007%2Fs11606-021-06666-z; Mark P. Sendak et al., A Path for Translation of Machine 
Learning Products into Healthcare Delivery, EMJ Innov., Jan. 27, 
2021, https://emj.emg-health.com/wp-content/uploads/sites/2/2020/01/A-Path-for-Translation-of-Machine-Learning.....pdf; Dew, supra note 
371.
    \373\ Julie Zauzmer Weil, DC Says Long-Awaited Translation of 
Vaccine Website Is Coming This Weekend, Wash. Post (Apr. 9, 2021), 
https://www.washingtonpost.com/local/coronavirus-vaccine-translation-spanish/2021/04/09/40ed126a-9942-11eb-962b-78c1d8228819_story.html.
    \374\ Dew, supra note 371, at 64.
---------------------------------------------------------------------------

    The Department proposes regulatory language requiring a covered 
entity that uses machine translation to have translated materials 
reviewed by a qualified human translator when the underlying text is 
critical to the rights, benefits, or meaningful access of an LEP

[[Page 47862]]

individual; when accuracy is essential; or when the source documents or 
materials contain complex, non-literal, or technical language.
    We seek comment on the use of machine translation in health 
programs and activities generally, other possible approaches to address 
this issue, and whether there should be an exception to this provision 
to allow for the limited use of machine translation in exigent 
circumstances.
    Proposed paragraph (d) addresses how the Director will evaluate 
compliance with this section. The 2015 NPRM in then-proposed Sec.  
92.201(b)(1) provided that the Director would evaluate a covered 
entity's compliance with meaningful access for LEP individuals by 
giving substantial weight to the nature and importance of the program 
or activity and the particular communication at issue.\375\ The 2015 
NPRM also identified five other relevant factors that the Director 
would consider.\376\ In response to comments, the preamble to the 2016 
Rule eliminated the list of five factors and articulated only one 
factor in former Sec.  92.201(b)(2): whether a covered entity had 
developed and implemented an effective written language access plan 
appropriate to its circumstances.\377\ Commenters suggested many other 
factors that could be included.\378\ The preamble explained that 
including multiple illustrative factors in the regulatory text may 
create the erroneous impression that the Director will not consider 
other relevant factors, and trying to capture all possible factors 
could result in an unintentionally unworkable regulatory scheme.\379\ 
Accordingly, the preamble to the 2016 Rule contains a lengthy list of 
factors that may be relevant in a particular case, including:
---------------------------------------------------------------------------

    \375\ 80 FR 54171, 54218 (Sept. 8, 2015).
    \376\ Id.
    \377\ 81 FR 31470.
    \378\ Id. at 31415.
    \379\ Id.

the length, complexity, and context of the communication; the 
prevalence of the language in which the individual communicates 
among those eligible to be served or likely to be encountered by the 
health program or activity; the frequency with which a covered 
entity encounters the language in which the individual communicates; 
whether a covered entity has explored the individual's preference, 
if any, for a type of language assistance service, as not all types 
of language assistance services may work as well as others in 
providing an individual meaningful access to the covered entity's 
health program or activity; the cost of language assistance services 
and whether a covered entity has availed itself of cost-saving 
opportunities; and all resources available to the covered entity, 
including the entity's capacity to leverage resources among its 
partners or to use its negotiating power to lower the costs at which 
language assistance services could be obtained.\380\
---------------------------------------------------------------------------

    \380\ Id. at 31416.

    At paragraph (d)(1), we propose that the Director shall evaluate, 
and give substantial weight to, the nature and importance of the health 
program or activity and the particular communication at issue, to the 
LEP individual. This is the same language as was included in the 2016 
Rule.\381\ Proposed paragraph (d)(2) provides that the Director shall 
take into account other relevant factors, including the effectiveness 
of the covered entity's written language access procedures for its 
health programs and activities, that the covered entity has implemented 
pursuant to proposed Sec.  92.8(d) of this part. In this proposed 
regulation, we are not requiring a formal language access plan; 
however, we continue to strongly encourage covered entities to develop 
such plans, in concert with developing and implementing language access 
procedures required under proposed Sec.  92.8(d), to be in a better 
position to meet their obligations to provide effective language 
services in a timely manner.
---------------------------------------------------------------------------

    \381\ Former 45 CFR 92.201(b)(1).
---------------------------------------------------------------------------

    The proposed language contrasts with the 2020 Rule which, at Sec.  
92.101(b)(1), provides that the Director will assess how the covered 
entity balances four factors,\382\ essentially adopting the ``four-
factor analysis'' found in the HHS LEP Guidance.\383\ The preamble to 
the 2020 Rule notes that ``some commenters believed that 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 weakens recipient 
language access obligations to serve persons who speak infrequently 
encountered languages.'' \384\ The 2020 Rule preamble states that OCR 
viewed the four-factor analysis as an appropriate way ``to allow 
flexibility for covered entities.'' \385\
---------------------------------------------------------------------------

    \382\ See 85 FR 37245.
    \383\ 68 FR 47311, 47314 (Aug. 8, 2003) (suggesting, as a 
starting point for covered entities meeting their obligations, the 
balancing of four factors: (1) the number or proportion of LEP 
persons eligible to be served or likely to be encountered by the 
program or grantee; (2) the frequency with which LEP individuals 
come in contact with the program; (3) the nature and importance of 
the program, activity, or service provided by the program to 
people's lives; and (4) the resources available to the grantee/
recipient and costs).
    \384\ 85 FR 37212.
    \385\ Id.
---------------------------------------------------------------------------

    During the four years that these provisions of the 2016 Rule were 
in effect, former Sec.  92.201(a) was never challenged. However, the 
standard contained in the 2020 Rule has been challenged in Federal 
district court. In Chinatown Service Center, plaintiffs alleged that 
the 2020 Rule's replacement of the standard in former Sec.  92.201(a) 
resulted in only a ``generalized duty'' to LEP individuals rather than 
a case-by-case review to ensure the covered entities take reasonable 
steps to provide each individual with limited English proficiency with 
necessary language assistance services.\386\
---------------------------------------------------------------------------

    \386\ See Chinatown Serv. Ctr. Compl., supra note 309.
---------------------------------------------------------------------------

    After reviewing and reconsidering comments received in response to 
the 2019 NPRM, we believe that the four-factor analysis is more 
appropriately described as a general framework for planning on a 
system-wide and site-level basis, but does not provide clarity as to 
what the covered entity's obligations are to a particular individual. 
The proposed rule applies the general obligation to take reasonable 
steps to provide meaningful access and focuses on the steps the covered 
entity must take for each individual in the health care setting.
    The level of specificity we propose is especially important when 
addressing benefits or services with high importance or consequences 
such as those provided in the health care setting. This specificity 
helps guide a covered entity by supplying a framework that they can 
choose to use, while providing a covered entity an appropriate level of 
flexibility to determine how best to comply with statutory and 
regulatory obligations to provide meaningful access to LEP individuals. 
Therefore, while we have taken the four-factor analysis into 
consideration in formulating the specific provisions, we decline to 
include it in this proposed regulation. We seek comment on this 
approach.
    Proposed paragraph (e) identifies restrictions on the use of 
certain persons to provide language assistance services for LEP 
individuals. This language is similar to that contained in the 2020 
Rule at Sec.  92.101(b)(4), with additional descriptors to ensure the 
best available and most accurate language assistance services in 
covered health programs and activities.\387\ Proposed paragraph (e)(1) 
prohibits covered entities from requiring LEP individuals to provide, 
or pay for,

[[Page 47863]]

their own interpreters. Proposed paragraph (e)(2) provides for very 
limited situations in which an adult, not qualified as an interpreter, 
accompanying an LEP individual can serve as an interpreter. The first 
limited circumstance includes 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 LEP individual immediately available. 
For example, directly following a natural disaster such as an 
earthquake, a covered entity may temporarily rely on a non-qualified 
interpreter to help first responders provide services to LEP 
individuals during emergency response and recovery efforts. This is 
permitted only as a temporary measure while finding a qualified 
interpreter, and the qualified interpreter that arrives must confirm or 
supplement the initial communications with the accompanying adult.
---------------------------------------------------------------------------

    \387\ 85 FR 37246.
---------------------------------------------------------------------------

    In the second limited circumstance, an adult who is not qualified 
as an interpreter may also serve as an interpreter when: an LEP 
individual specifically requests that the accompanying adult interpret 
or facilitate communication; the accompanying adult agrees to provide 
such assistance; the request and agreement by the accompanying adult is 
documented; and reliance on that adult for such assistance is 
appropriate under the circumstances. When considering whether the 
reliance on such an adult to interpret without confirming or 
supplementing the interpretation is appropriate, the covered entity 
should consider the accompanying adult's language proficiency in both 
English and the primary language of the LEP individual; the possibility 
of bias; whether the individual is an interested party, such as in 
situations of domestic violence; and whether the accompanying adult 
helps the covered entity better understand the LEP individual. Covered 
entities should also keep in mind that untrained ``interpreters'' are 
more likely to make errors, violate confidentiality, and increase the 
risk of poor outcomes.\388\ If the covered entity is unable to make the 
required assessment, relying on the accompanying adult is 
inappropriate.
---------------------------------------------------------------------------

    \388\ Gregory Juckett & Kendra Unger, Appropriate Use of Medical 
Interpreters, 90 A. Fam. Physician 476 (2014), https://www.aafp.org/pubs/afp/issues/2014/1001/p476.html.
---------------------------------------------------------------------------

    Proposed paragraph (e)(3) prohibits a covered entity from relying 
on a minor child to interpret or facilitate communication, except as a 
temporary measure while finding a qualified interpreter 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 LEP 
individual immediately available--for example, directly following a 
serious car accident where, due to the nature of the injuries 
sustained, an LEP individual's critical care is a priority. Once the 
qualified interpreter has arrived, they must confirm or supplement the 
initial communications with the minor child. The use of children as 
interpreters raises the same concerns as those of an accompanying adult 
who is not qualified as an interpreter, but also poses other problems 
including exposing children to complex health care interactions for 
which they are not developmentally prepared, upsetting a family power 
dynamic, causing embarrassment, and conveying incorrect or incomplete 
information.\389\
---------------------------------------------------------------------------

    \389\ See, e.g., Sunmin Lee et al., Barriers to Health Care 
Access in 13 Asian American Communities, 45 Am. J. Health Behav. 21, 
22 (2010), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6628721/; 
Wooksoo, supra note 106, at 289.
---------------------------------------------------------------------------

    Proposed paragraph (e)(4) prohibits reliance on staff other than 
qualified interpreters, qualified translators, or qualified bilingual 
or multilingual staff to communicate directly with LEP individuals.
    Proposed paragraph (f) addresses standards for video remote 
interpreting (VRI) and is identical to former Sec.  92.201(f) in the 
2016 Rule.\390\ The preamble to that rule states the purpose of 
developing VRI standards was to address concerns that the use of this 
technology may result in less comprehensible communication. The 2016 
Rule preamble also explains that the VRI standards are designed to 
achieve parity with the regulation in the disability rights 
context.\391\ These standards closely parallel those standards set 
forth in proposed Sec.  92.202 regarding effective communication for 
individuals with disabilities, which, similar to the 2016 Rule, relies 
on standards in Title II of the ADA for the use of sign language 
interpreters.
---------------------------------------------------------------------------

    \390\ 81 FR 31375, 31470-71 (May 18, 2016).
    \391\ Id. at 31418.
---------------------------------------------------------------------------

    The 2020 Rule does not address VRI services. The preamble explains 
that in place of VRI standards, the final rule adopts the four-factor 
analysis ``which will help covered entities balance competing 
considerations related to VRI quality standards.'' \392\ The 2020 Rule 
RIA states that ``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 a clear audio 
transmission through the remote interpreting service.'' \393\ The 
Department disagrees with this assessment. Performance standards are 
necessary so that VRI technologies do not result in ineffective 
communication. The plain terms of this provision do not require a 
covered entity to provide VRI but rather ensure that when such services 
are used, they must meet a quality standard.
---------------------------------------------------------------------------

    \392\ 85 FR 37213.
    \393\ Id. at 37223.
---------------------------------------------------------------------------

    Proposed paragraph (g) sets forth standards for audio remote 
interpreting services. Those standards, which are likewise important in 
order to have meaningful communication, are identical to those in the 
2020 Rule at Sec.  92.101(b)(3)(iii).\394\
---------------------------------------------------------------------------

    \394\ Id. at 37246.
---------------------------------------------------------------------------

    Proposed paragraph (h) states that nothing in this section shall be 
construed to require an LEP individual to accept language assistance 
services. Identical language is contained in the 2020 Rule at Sec.  
92.101(c), and the 2016 Rule at former Sec.  92.101(g).\395\
---------------------------------------------------------------------------

    \395\ Id.
---------------------------------------------------------------------------

Effective Communication for Individuals With Disabilities (Sec.  
92.202)

    Proposed Sec.  92.202 addresses requirements related to providing 
effective communication for individuals with disabilities. The 2020 
Rule at Sec.  92.102 and the 2016 Rule at former Sec.  92.202 contain 
substantially the same requirements as this proposed section.
    In proposed paragraph (a), we require a covered entity to take 
appropriate steps to ensure that communications with individuals with 
disabilities, and companions with disabilities, are as effective as 
communications with individuals without disabilities in its health 
programs and activities, incorporating the standards found at 28 CFR 
35.130 and 35.160 through 35.164 of the regulation implementing Title 
II of the ADA. Proposed paragraph (a) is similar to the 2020 Rule at 
Sec.  92.102(a), with the addition of ``companions'' to codify the 
Department's longstanding position that a covered entity's obligation 
to ensure effective communication extends not just to individuals with 
disabilities but to companions as well, if they are individuals with 
disabilities.\396\
---------------------------------------------------------------------------

    \396\ Consistent with the Department's position in the 2016 
Rule; 42 U.S.C. 12182(b)(1)(E)(Title III); 28 CFR 35.130(g) (Title 
II). See generally, U.S. Equal Emp't Opportunity Comm'n, Questions & 
Answers: Association Provision of the ADA (Oct. 17, 2005), https://www.eeoc.gov/laws/guidance/questions-answers-association-provision-ada; cf. Loeffler v. Staten Island Univ. Hosp., 582 F.3d 268, 277 
(2d Cir. 2009) (permitting associational discrimination claim under 
Section 504); Falls v. Prince George's Hosp. Ctr., No. Civ. A 97-
1545, 1999 WL 33485550, at *11 (D. Md. Mar. 16, 1999) (holding that 
parent had an associational discrimination claim under Section 504 
when hospital required hearing parent to act as interpreter for 
child who was deaf).

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

[[Page 47864]]

    Because we propose to incorporate all of the relevant Title II 
standards into proposed paragraph (a), including requirements that were 
enumerated in the 2020 Rule (e.g., the requirements to provide 
auxiliary aids and services in a timely manner and free of charge, and 
to give primary consideration to the requests of individuals with 
disabilities when determining what types of auxiliary aids and services 
are necessary), we do not propose to enumerate these specific 
additional standards in this rule. This proposed section also clarifies 
that where the regulatory provisions referenced in this section use the 
term ``public entity,'' the term ``covered entity'' shall apply in its 
place.
    We propose in paragraph (b) to explicitly require covered entities 
to provide appropriate auxiliary aids and services to individuals with 
impaired sensory, manual, or speaking skills, where necessary to afford 
such individuals an equal opportunity to benefit from the service in 
question. Once again, this paragraph is substantially similar to the 
2020 Rule at Sec.  92.102(b), which applied to recipients and State 
Exchanges. Because all covered entities, including the Department, are 
required to provide auxiliary aids and services, we propose to apply 
paragraph (b) to all covered entities, not just recipients and State 
Exchanges.\397\
---------------------------------------------------------------------------

    \397\ The Department is required to provide appropriate 
auxiliary aids and services under 45 CFR 85.51(a)(1) of this 
subchapter, which is incorporated by reference under proposed Sec.  
92.101(b)(1)(ii).
---------------------------------------------------------------------------

    We also note that in order to ensure a covered entity meets its 
obligations to provide both meaningful access and effective 
communication for LEP individuals with disabilities, it must comply 
with both proposed Sec.  92.201 and proposed Sec.  92.202. Auxiliary 
aids and services that are not provided in a language consistent with 
proposed Sec.  92.201 do not satisfy the requirements of proposed Sec.  
92.202. For example, a covered entity that only offered auxiliary aids 
and services in English to an LEP individual with a disability may be 
in violation of both proposed Sec.  92.201 and Sec.  92.202.
    The 2020 Rule defines ``disability,'' ``auxiliary aids and 
services'' and ``qualified interpreter'' at Sec.  92.201; those 
definitions are now located in proposed Sec.  92.4.

Accessibility for Buildings and Facilities (Sec.  92.203)

    Proposed Sec.  92.203 adds a general provision establishing that no 
qualified individual with a disability shall, because a covered 
entity's facilities are inaccessible to or unusable by individuals with 
disabilities, be denied the benefits of, be excluded from participation 
in, or otherwise be subjected to discrimination under any health 
program or activity to which this part applies, consistent with the 
Department's Section 504 regulation covering federally assisted and 
federally conducted programs and activities.\398\ The remainder of 
proposed Sec.  92.203 incorporates the identical language found in the 
2020 Rule at Sec.  92.103, except that the definitions for ``1991 
Standards,'' ``2010 Standards,'' and ``UFAS'' are now located in 
proposed Sec.  92.4.
---------------------------------------------------------------------------

    \398\ 45 CFR 84.21 (federally assisted); Sec.  85.41 (federally 
conducted).
---------------------------------------------------------------------------

Accessibility of Information and Communication Technology for 
Individuals With Disabilities (Sec.  92.204)

    Proposed Sec.  92.204 addresses the accessibility of information 
and communication technology (ICT) for individuals with disabilities. 
This proposed section is substantially the same as Sec.  92.104(a)-(b) 
of the 2020 Rule and former Sec.  92.204 of the 2016 Rule. The 2020 
Rule also defines ``information and communication technology'' at Sec.  
92.104(c), which we propose to define at proposed Sec.  92.4.
    With the advent of COVID-19 constraints placed on in-person 
services, the use of technology has become ever more critical. Covered 
entities have adapted creatively utilizing remote communications 
technologies to provide telehealth services, including audio, text 
messaging or video conferencing. Additionally, websites and online 
portals are serving as primary registration vehicles for obtaining 
COVID-19 tests and vaccines. In some instances, however, the use of 
inaccessible websites or online portals has resulted in access barriers 
for individuals with disabilities. For example, individuals with vision 
impairments who use screen reader software or persons with mobility 
impairments who have difficulty using a mouse, may not be able to 
access inaccessible online registration forms or navigate inaccessible 
vaccine websites.\399\
---------------------------------------------------------------------------

    \399\ See e.g., Press Release, U.S. Dep't of Just., Justice 
Department Secures Settlement with Rite Aid Corporation to Make Its 
Online Covid-19 Vaccine Portal Accessible to Individuals with 
Disabilities (Nov. 1, 2021), https://www.justice.gov/usao-mdpa/pr/justice-department-secures-settlement-rite-aid-corporation-make-its-online-covid-19.
---------------------------------------------------------------------------

    Many covered entities are currently relying on Section 508 
standards promulgated by the Access Board or Web Content Accessibility 
Guidelines (WCAG) developed through the Worldwide Web Consortium's 
(W3C) Web Accessibility Initiative to ensure that their ICT is 
accessible to individuals with disabilities.\400\ Additionally, 
multiple states have laws or policies addressing accessibility of ICT 
with which entities covered by those statutes must comply.\401\ Over 
time, the feasibility of technological applications and solutions has 
continued to develop and dramatically change the way the public 
interacts with health programs and activities.
---------------------------------------------------------------------------

    \400\ See Press Release, U.S. Dep't of Just., Justice Department 
Issues Web Accessibility Guidance Under the Americans with 
Disabilities Act (Mar. 18, 2022), https://www.justice.gov/opa/pr/justice-department-issues-web-accessibility-guidance-under-americans-disabilities-act.
    \401\ Policy & Management: State Policy, Section508.gov, https://www.section508.gov/manage/laws-and-policies/state/ (last visited 
June 15, 2022).
---------------------------------------------------------------------------

    Proposed paragraph (a) requires covered entities to ensure that 
their health programs and activities provided through ICT 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. If an 
action required to comply with this subpart would result in such an 
alteration or burdens, a covered entity is required to take any other 
action that would not result in such an alteration or burdens but would 
nevertheless enable, to the maximum extent possible, individuals with 
disabilities to receive the benefits or services of the health program 
or activity provided by the covered entity.
    Proposed paragraph (b) requires recipients and State Exchanges to 
ensure that their health programs and activities provided through 
websites and mobile applications comply with the requirements of 
Section 504 as interpreted in a manner consistent with Title II of the 
ADA. Both the 2020 Rule and the 2016 Rule have the same provision as it 
applies to recipient and State Exchange websites. We propose to modify 
this provision by extending it to mobile applications in addition to 
websites.
    Given the heightened impact ICT has on individuals with 
disabilities in health programs and activities, as

[[Page 47865]]

evidenced by COVID-19, OCR is seeking comments on whether the Section 
1557 rule should include a provision requiring covered entities to 
comply with specific accessibility standards, such as the Web Content 
Accessibility Guidelines (WCAG) developed by the Web Accessibility 
Initiative. Additionally, OCR seeks comments on whether to adopt a safe 
harbor provision under which covered entities that are in compliance 
with established specific accessibility standards are deemed in 
compliance with proposed paragraphs (a) and (b) of this section; 
whether OCR should require covered entities to comply with the most 
recent edition of a published standard; and the timeline necessary for 
covered entities to come into compliance with a new standard.

Requirement To Make Reasonable Modifications (Sec.  92.205)

    Proposed Sec.  92.205 requires covered entities to make reasonable 
modifications to 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. This provision is the same as Sec.  92.105 of the 
2020 Rule and former Sec.  92.205 of the 2016 Rule. 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 implementing Title II of the ADA at 28 CFR 
35.130(b)(7).\402\
---------------------------------------------------------------------------

    \402\ See discussion supra Sec.  92.3 (addressing need for 
parity between Section 504 and the ADA).
---------------------------------------------------------------------------

Equal Program Access on the Basis of Sex (Sec.  92.206)

    The Department proposes to include a section clarifying covered 
entities' obligation to ensure equal access to their health programs 
and activities without discrimination on the basis of sex, including 
pregnancy, sexual orientation, gender identity, and sex 
characteristics.\403\ This provision primarily relates to covered 
entities that are directly engaged in the provision of health care 
services, such as hospitals, physical and mental health care providers, 
and pharmacies. While the 2016 Rule included a section on equal program 
access on the basis of sex, the 2020 Rule does not include an analogous 
provision. As Section 1557 is the only Federal civil rights law 
explicitly prohibiting sex discrimination in health programs and 
activities, the Department believes that it is beneficial to both 
covered entities and the public to have additional regulatory clarity. 
Nondiscrimination by covered entities in the provision or 
administration of health insurance coverage and other health-related 
coverage is addressed in proposed Sec.  92.207.
---------------------------------------------------------------------------

    \403\ See discussion supra section II.B. (The 2020 Rule's 
Preamble Does Not Reflect Recent Developments in Civil Rights Law).
---------------------------------------------------------------------------

    Proposed Sec.  92.206(a) describes a covered entity's general 
obligation to provide individuals equal access to the covered entity's 
health programs or activities without discrimination on the basis of 
sex. The Department proposes paragraphs (b)(1)-(4) to clarify certain 
types of discriminatory actions that would be prohibited for a covered 
entity in its provision of access to health programs or activities.
    As is true for any claim of discrimination under this proposed 
rule, and consistent with the Department's standard practice for 
investigating such claims, OCR may use the tools of longstanding civil 
rights case law in analyzing claims of discrimination under paragraph 
(b). These tools include, but are not limited to, the multi-factor test 
articulated in Arlington Heights,\404\ and the McDonnell Douglas \405\ 
burden-shifting framework. Explained in great depth in the DOJ's Title 
VI Legal Manual, Arlington Heights is a method of proof that uses a 
number of different types of circumstantial evidence that, taken 
collectively, can demonstrate that the covered entity acted, at least 
in part, because of a protected basis. Under this test, evidence of 
disparate impact can be one piece of evidence that is considered in 
determining whether there is intentional discrimination. This framework 
is most commonly applied in cases alleging discrimination against a 
group.\406\ The McDonnell Douglas burden-shifting framework, however, 
is most commonly applied in cases alleging discrimination in individual 
instances and is an inferential method of proof that is used to show 
that a defendant treated similarly situated individuals differently 
because of a protected basis.\407\ Under McDonnell Douglas, where there 
is a prima facie case of discrimination against a covered entity, that 
covered entity must articulate a legitimate, nondiscriminatory reason 
for its actions. This legitimate, nondiscriminatory reason would be a 
defense against the claim of discrimination, unless it can be 
established that this reason is in fact a mere pretext for prohibited 
discrimination.
---------------------------------------------------------------------------

    \404\ Vill. of Arlington Heights v. Metro. Housing Dev. Corp., 
429 U.S. 252, 266-68 (1977).
    \405\ McDonnell Douglas Corp. v. Green, 411 U.S. 792 (1973).
    \406\ U.S. Dep't of Just., Title VI Legal Manual, sec. VI.B.2.
    \407\ Id. at sec. VI.B.3.
---------------------------------------------------------------------------

    Proposed paragraph (b)(1) provides a general prohibition on the 
denial or limitation of health services, including those that are 
offered exclusively to individuals of one sex, to an individual based 
on the individual's sex assigned at birth, gender identity, or gender 
otherwise recorded. The text of this proposed paragraph is similar to 
former Sec.  92.206 of the 2016 Rule, which provided that ``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.'' \408\ The 2020 Rule does not include a similar provision. 
The Department proposes to not include the word ``transgender'' in this 
proposed provision. This approach recognizes that the form of 
discrimination discussed herein may impact a range of individuals, 
including transgender people, individuals with intersex conditions, or 
people who may need these services but do not identify as transgender.
---------------------------------------------------------------------------

    \408\ See 81 FR 311375, 31471 (May 18, 2016).
---------------------------------------------------------------------------

    The Department's review of the literature indicates that this 
provision is warranted based on continued discrimination experienced by 
transgender and gender non-conforming individuals as they seek basic 
medical care. For example, transgender men who are pregnant experience 
significant forms of ``discrimination, stigma, and erasure'' when 
navigating pregnancy and prenatal care, particularly because pregnancy 
and childbirth are often treated as something exclusively experienced 
by cisgender women.\409\
---------------------------------------------------------------------------

    \409\ Margaret Besse et al., Experiences with Achieving 
Pregnancy and Giving Birth Among Transgender Men: A Narrative 
Literature Review, 93 Yale J. of Biology & Med. 517, 518 (2020).
---------------------------------------------------------------------------

    Under this provision, a covered entity that routinely provides 
gynecological or obstetric care could not deny an individual a pelvic 
exam or pregnancy-related care because the individual is a transgender 
man or nonbinary person assigned female at birth, if the entity 
otherwise provides that care to cisgender individuals. Similarly, a 
community clinic that receives funding from the Department could not 
refuse to provide a transgender woman a prostate cancer screening 
because her sex is

[[Page 47866]]

listed female in her electronic health record, if the entity otherwise 
provides these screenings to cisgender individuals.
    Proposed paragraph (b)(2) prohibits covered entities from denying 
or limiting a health care professional's ability to provide health 
services on the basis of a patient's sex assigned at birth, gender 
identity, or gender otherwise recorded. This provision recognizes that 
prohibited discrimination may take the form of attempted restrictions 
on individual providers, such as attending physicians, that have the 
effect of discriminating against patients, in addition to 
discriminatory actions that target patients directly. This is similar 
to Title VI's limited application to employment when a recipient's 
``discrimination has a secondary effect on the ability of beneficiaries 
to participate meaningfully in and/or receive the benefits of a 
federally assisted program in a nondiscriminatory manner.'' \410\
---------------------------------------------------------------------------

    \410\ U.S. Dep't of Just., Title VI Legal Manual, sec. X.A.
---------------------------------------------------------------------------

    Under this provision, a covered entity is also prohibited from 
punishing or disciplining a provider for providing clinically 
appropriate care where doing so would have the impact of limiting that 
provider's ability to provide such care on the basis of a patient's 
assigned sex at birth, gender identity, or gender otherwise recorded. 
As with all proposed paragraphs in this section, this provision does 
not require covered entities to perform services outside of their 
specialty area. However, restrictions by covered entities on the 
ability of providers to prescribe or provide care based on their 
patient's gender identity or sex assigned at birth would likely 
constitute prohibited discrimination in violation of this rule.
    Proposed paragraph (b)(3) would prohibit a covered entity from 
applying any policy or practice of treating individuals differently or 
separating them on the basis of sex in a manner that subjects any 
individual to more than de minimis harm. The 2016 Rule provided, at 
former Sec.  92.101(b)(3)(iv), that sex-specific health programs and 
activities were allowable only where the covered entity could 
``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.'' The 2020 Rule repealed this provision, finding that the 
provision ``placed an unjustified burden on sex-specific health 
programs and activities conducted by private entities'' by adopting the 
Equal Protection standard that otherwise applies only to governmental 
actions that discriminate on the basis of sex.\411\ The Department has 
considered the approaches taken in the 2016 and 2020 Rules and believes 
that while it is important to include a provision on this issue, the 
Constitutional standard is not the most appropriate for a regulation 
that applies to governmental and non-governmental actors. Rather, we 
believe the standard proposed now is the more appropriate approach.
---------------------------------------------------------------------------

    \411\ 85 FR 37160, 37196 (June 19, 2020).
---------------------------------------------------------------------------

    Although differential treatment on the basis of sex is generally 
prohibited, the Department acknowledges that there are certain 
circumstances in which Section 1557 does not prohibit separation by sex 
or differential medical treatment on the basis of sex, namely, where it 
does not cause more than de minimis harm. A sex-based distinction that 
has only a minimal impact is not a form of ``discrimination'' that 
Congress intended to prohibit,\412\ and an individual shall not be 
deemed subject to discrimination under this part by reason of the fact 
that an otherwise lawful health program or activity has chosen to 
utilize such sex-based distinctions consistent with the requirements of 
this rule. For example, the practice of assigning patients to dual-
occupancy rooms in hospitals and in-patient treatment facilities on the 
basis of sex is not, standing alone, a form of discrimination.
---------------------------------------------------------------------------

    \412\ See, e.g., Oncale v. Sundowner Offshore Servs., Inc., 523 
U.S. 75, 81 (1998) (Title VII does not reach non-harmful 
``differences in the ways men and women routinely interact with'' 
each other); see also Burlington N. & Santa Fe Ry. Co. v. White, 548 
U.S. 53, 59-60 (2006) (``No one doubts that the term `discriminate 
against' refers to distinctions or differences in treatment that 
injure protected individuals.''); Threat v. City of Cleveland, 6 
F.4th 672, 678 (6th Cir. 2021) (``To `discriminate' reasonably 
sweeps in some form of an adversity and a materiality threshold.'').
---------------------------------------------------------------------------

    However, the Department may still find that a covered entity 
violates Section 1557 if it implements the sex-based distinction in a 
way that constitutes discrimination, by imposing more than de minimis 
harm upon a particular individual. This is what Title IX requires.\413\
---------------------------------------------------------------------------

    \413\ See Peltier v. Charter Day Sch., Inc., Nos. 20-1001, 20-
1023, 2022 WL 2128579, at *16 (4th Cir. June 14, 2022) (en banc) 
(``for the plaintiffs to prevail under Title IX, they must show that 
. . . the challenged action caused them harm, which may include 
`emotional and dignitary harm' '' (internal citation omitted)).
---------------------------------------------------------------------------

    Discriminatory harm that is more than de minimis may include any 
adverse effect on a person's equal access to or participation in a 
covered entity's health program or activity based on sex. This 
provision does not, however, prohibit a covered entity from treating an 
individual for conditions that may be specific to their sex 
characteristics. For example, it would be permissible for an emergency 
department to treat a transgender man with a positive human chorionic 
gonadotropin (pregnancy) test as a pregnant person, even though 
pregnancy is generally associated with ``female'' sex characteristics, 
such as having a functioning uterus and ovaries.\414\ Similarly, sex-
specific clinical trials may be permissible based upon the scientific 
purposes of the study, i.e., trials based on a particular sex-
characteristic(s), such as those that test treatments for specific 
conditions or that evaluate differences in responses to treatment 
regimens among individuals with different sex characteristics. In 
evaluating a complaint of discrimination challenging a covered entity's 
sex-specific health program or activity, OCR may consider a variety of 
factors relevant to the particular health program or activity.
---------------------------------------------------------------------------

    \414\ See, e.g., Daphna Strousma et al., The Power and Limits of 
Classification--A 32-Year-Old Man with Abdominal Pain, 380 N. Eng. 
J. Med. 1885 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395710/pdf/nihms-1609250.pdf.
---------------------------------------------------------------------------

    In particular, this provision would prohibit the adoption of a 
policy, or engaging in a practice, that prevents any individual from 
participating in a covered entity's health program or activity 
consistent with their gender identity. The 2016 Rule required that 
covered entities ``treat individuals consistent with their gender 
identity'' at former Sec.  92.206; as discussed previously, the 2020 
Rule preamble indicated that Section 1557 likely did not prohibit 
discrimination on the basis of gender identity as a form of prohibited 
sex discrimination, and therefore did not include a similar provision. 
The Department believes this provision is necessary to better 
effectuate Section 1557's purpose: to eliminate sex discrimination in a 
range of health programs and activities. Reading Section 1557's 
prohibition of sex discrimination consistently with the reasoning in 
Bostock, discrimination on the basis of gender identity necessarily 
involves consideration of an individual's sex--even if that term is 
narrowly defined--and Section 1557's prohibition covers discrimination 
on that basis. For example, a hospital that assigns patients to dual-
occupancy rooms based on sex would be prohibited from requiring a 
transgender woman to share a room with a cisgender man,

[[Page 47867]]

regardless of how her sex is recorded in her insurance or medical 
records.\415\
---------------------------------------------------------------------------

    \415\ See, e.g., Bulletin, U.S. Dep't of Health & Human Servs., 
The Brooklyn Hospital Center Implements Non-Discriminatory Practices 
to Ensure Equal Care for Transgender Patients (July 14, 2015), 
https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/statement.pdf.
---------------------------------------------------------------------------

    Proposed paragraph (b)(4) prohibits a covered entity from denying 
or limiting health services sought for the purpose of gender-affirming 
care that the covered entity would provide to a person for other 
purposes if the denial or limitation is based on a patient's sex 
assigned at birth, gender identity, or gender otherwise recorded.
    This preamble generally uses the phrase ``gender transition or 
gender-affirming care.'' Relevant clinical guidelines acknowledge that 
not all individuals for whom such care is clinically appropriate will 
specifically identify as transgender, nor will all gender-affirming 
care specifically be related to transition from one binary gender to 
another.\416\ For example, people seeking gender-affirming care may 
refer to their gender identity using terms other than ``transgender,'' 
such as ``nonbinary,'' ``gender nonconforming,'' ``genderqueer,'' or 
``genderfluid.'' Individuals using any of these terms may have a gender 
dysphoria diagnosis and seek clinically appropriate gender-affirming 
care. A person's use of particular identity terminology is not 
determinative of whether the care in question is appropriate.
---------------------------------------------------------------------------

    \416\ WPATH Standards, supra note 139, at pp. 8-9.
---------------------------------------------------------------------------

    There also may be variations in the types of health services that 
are sought or are clinically appropriate for each person (e.g., some 
people undergo hormone therapy as part of gender transition but do not 
seek any surgical care).\417\ Additionally, some transgender people 
might not seek or require health interventions as part of their gender 
transition or gender-affirmation process. Nothing in this preamble or 
the regulatory text is intended to limit the application of provisions 
discussing gender-affirming care or transition-related care based on 
whether an individual uses particular terms to describe their gender 
identity or seeks only certain types of gender-affirming or transition-
related care. The Department welcomes comments on this choice of 
terminology in the regulatory text, particularly from individuals 
seeking and providing such care.
---------------------------------------------------------------------------

    \417\ Id.
---------------------------------------------------------------------------

    Importantly, this provision does not require health care 
professionals to perform services outside of their normal specialty 
area; therefore a provider that declines to provide services outside 
its specialty area would have a legitimate, nondiscriminatory reason 
for its action. This is consistent with the Department's position under 
Section 504 regarding medical specialization. As explained in Appendix 
A to the Department's Section 504 implementing regulation, ``[a] burn 
treatment center need not provide other types of medical treatment to 
[individuals with disabilities] unless it provides such medical 
services to [persons without disabilities]. It could not, however, 
refuse to treat the burns of a deaf person because of his or her 
deafness.'' \418\ This provision also does not compel a provider to 
prescribe a specific treatment that the provider decides not to offer 
after making a nondiscriminatory bona fide treatment decision. For 
example, a family practice covered by the rule would not be required to 
provide transition-related surgery where surgical care is not within 
its normal area of practice. Nor would the proposed rule require a 
pediatrician to prescribe hormone blockers for a prepubescent gender-
nonconforming minor if that health care provider concluded, pursuant to 
a nondiscriminatory bona fide treatment decision, that social 
transition was the clinically indicated next step for that child.
---------------------------------------------------------------------------

    \418\ See 45 CFR pt. 84, app. A, subpt. F.
---------------------------------------------------------------------------

    By contrast, a gynecological surgeon may be in violation of the 
rule if they accept a referral for a hysterectomy but later refuse to 
perform the surgery upon learning the patient is a transgender man. If 
OCR were to receive a complaint in a case such as this, it would 
evaluate whether the provider had a legitimate basis for concluding 
that the surgery would not be clinically appropriate for the patient. 
If the surgeon invokes such a justification, OCR would make a 
determination as to whether the reason was a pretext for 
discrimination. OCR would also consider the application of Federal 
conscience and religious freedom laws, where relevant.
    Proposed paragraph (c) provides that nothing in this section 
requires the provision of any health service where the covered entity 
has a legitimate, nondiscriminatory reason for denying or limiting that 
service, including where the covered entity reasonably determines that 
such health service is not clinically appropriate for that particular 
individual. However, a provider's view that no gender transition or 
other gender-affirming care can ever be beneficial for such individuals 
(or its compliance with a state or local law that reflects a similar 
judgment) is not a sufficient basis for a judgment that a health 
service is not clinically appropriate. Paragraph (c) is consistent with 
the general principle in nondiscrimination law that covered entities 
facing allegations of discrimination have the opportunity to articulate 
a legitimate, nondiscriminatory basis for their challenged action or 
practice.\419\ For example, a covered entity would not be required to 
perform a cervical exam on an individual who does not have a cervix, or 
to perform a prostate exam on an individual who does not have a 
prostate.
---------------------------------------------------------------------------

    \419\ See, e.g., McDonnell Douglas Corp. v. Green, 411 U.S. 792, 
802 (1973); U.S. Dep't of Just., Title IX Legal Manual, sec. IV.A.1; 
id. at sec. VI.B.3; see also Vill. of Arlington Heights v. Metro. 
Hous. Dev. Corp., 429 U.S. 252 (1977) (enumerating factors to be 
considered in evaluating whether a policy or practice is motivated 
by discriminatory intent); U.S. Dep't of Just., Title VI Legal 
Manual, sec. VI.B.2.
---------------------------------------------------------------------------

    In evaluating whether a facially sex-neutral asserted basis is 
pretextual, OCR may consider whether a determination that care is not 
clinically appropriate is based on generally accepted scientific or 
medical standards. For example, a clinic could not raise a defense 
under this provision if they denied a transgender woman a prostate exam 
based on the provider's belief that prostate exams are never clinically 
appropriate for women, if in fact the particular patient has a 
prostate. Nor would this provision provide a defense to a provider 
denying testosterone therapy to an intersex woman with complete 
androgen insensitivity syndrome based on a categorical belief that such 
therapy is never clinically appropriate for women.\420\
---------------------------------------------------------------------------

    \420\ See Wiebke Birnbaum et al., Oestrogen Versus Androgen in 
Hormone-Replacement Therapy for Complete Androgen Insensitivity 
Syndrome: A Multicentre, Randomised, Double-Dummy, Double-Blind 
Crossover Trial, 10 Lancet Diabetes Endocrinol. 771 (2018), https://pubmed.ncbi.nlm.nih.gov/30075954/.
---------------------------------------------------------------------------

    Similarly, OCR recognizes that providers often need to make 
inquiries about a patient's sex-related medical history, health status, 
or physical traits related to sex in the course of providing care. Such 
inquiries are not per se discriminatory, even where they touch on 
intimate or sensitive matters, but should be related to the underlying 
condition. For example, it is not discriminatory--i.e., it does not 
result in more than de minimis harm--for a provider treating a patient 
presenting with symptoms consistent with an ectopic pregnancy to 
inquire about the possibility that the patient could be pregnant, 
regardless of that patient's gender identity. However, where they are 
relevant to allegations of

[[Page 47868]]

discrimination, OCR may consider whether such inquiries are related to 
providing the care sought. Where such inquiries do not have a 
relationship to the care provided, or where they are made in a manner 
that is harassing, hostile, or evinces disregard for a patient's 
privacy, OCR may consider whether a provider's inquiries may be 
evidence of discrimination. For example, if a provider refused to 
provide treatment for a broken arm unless the patient answered 
questions about their history of genital surgery, OCR would consider 
whether there was any medical rationale for asking the question or 
whether it was mere pretext for discrimination, given the lack of 
connection between the question and the care being provided.\421\ 
Similarly, a provider's repeated questions about whether a patient had 
had breast augmentation surgery could be considered as evidence of 
discrimination where such questions were unrelated to the care 
provided, especially if the manner of the questioning had other indicia 
of harassment. Where relevant, OCR will consider the totality of the 
circumstances in determining whether overbroad, irrelevant, or hostile 
inquiries may constitute evidence of discrimination.
---------------------------------------------------------------------------

    \421\ See, e.g., David Oliver, `Being Transgender Is Not a 
Medical Condition': The Meaning of Trans Broken Arm Syndrome, USA 
Today (last updated Mar. 31, 2022), https://www.usatoday.com/story/life/health-wellness/2021/07/27/trans-broken-arm-syndrome-what-it-how-combat-discrimination-health-care/8042475002/; Douglas Knutson 
et al., ``Trans Broken Arm'': Health Care Stories from Transgender 
People in Rural Areas, 7 J. of Rsch. on Women & Gender 30 (2016), 
https://journals.tdl.org/jrwg/index.php/jrwg/article/download/97/50.
---------------------------------------------------------------------------

    Proposed paragraph (d) provides that the enumeration of specific 
forms of discrimination in paragraph (b) does not limit the general 
applicability of the prohibition in paragraph (a) of this section.
    The Department believes that the provisions in proposed Sec.  
92.206 are consistent with, and in furtherance of, Section 1554 of the 
ACA, which prohibits the Secretary of HHS from promulgating a 
regulation that ``interferes with communications regarding a full range 
of treatment options between patient and the provider,'' or ``restricts 
the ability of health care providers to provide full disclosure of all 
relevant information to patients making health care decisions.'' \422\ 
The provision as written supports and encourages health care providers' 
ability to discuss a full range of treatment options with their 
patients and in no way restricts providers' ability to share the range 
of risks and benefits associated with each treatment option. As 
discussed throughout this section, the provisions here do not compel a 
particular treatment for any given condition; rather, this section 
prohibits health care providers from discriminating against individuals 
on the basis of sex, including gender identity. Gender-affirming care, 
like all medical care, should follow clinical practice guidelines and 
professional standards of care.\423\ Informed consent to any medical 
treatment is both a legal and ethical standard, regardless of the type 
of care, and serves as a basis for shared decision making.\424\ When 
providing gender-affirming medical care for minors, informed consent 
involves discussions among providers, minors, and parents or 
guardians.\425\
---------------------------------------------------------------------------

    \422\ 42 U.S.C. 18114(3), (4).
    \423\ See e.g., WPATH Standards, supra note 139; Wylie Hembree 
et al., Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent 
Persons: An Endocrine Society Clinical Practice Guideline, 102 J. 
Clinical Endocrinology & Metabolism 3869 (2017), https://academic.oup.com/jcem/article/102/11/3869/4157558.
    \424\ Am. Med. Ass'n, Informed Consent, https://www.ama-assn.org/delivering-care/ethics/informed-consent (last visited June 
15, 2022).
    \425\ Hilary Cass, The Cass Review, Independent Review of Gender 
Identity Services for Children and Young People: Interim Report 
(2022), https://cass.independent-review.uk/publications/interim-report/.
---------------------------------------------------------------------------

    We seek comment on this section, including whether it adequately 
addresses the forms of discrimination faced by individuals on the basis 
of sex (including pregnancy, sexual orientation, gender identity, and 
sex characteristics) when seeking access to and participating in health 
programs and activities; whether the proposed regulation text captures 
the policies set forth in this preamble; what sex-based distinctions, 
if any, should be permitted in the context of health programs and 
activities; and the standards for permitting such distinctions that do 
not result in more than de minimis harm.
    We also invite comment on whether additional regulatory language 
should be added to specifically address the circumstance in which a 
provider offers a particular health treatment, service or procedure for 
certain purposes, but refuses to offer that same treatment, service or 
procedure for gender-transition or other gender-affirming care purposes 
because they believe it would not be clinically appropriate.

Nondiscrimination in Health Insurance Coverage and Other Health-Related 
Coverage (Sec.  92.207)

    Proposed Sec.  92.207 prohibits discrimination on the basis of 
race, color, national origin, sex, age, or disability in the provision 
or administration of health insurance coverage and other health-related 
coverage. This proposed section would apply to all covered entities 
that provide or administer health insurance coverage or other health-
related coverage that receive Federal financial assistance, and the 
Department in the administration of its health-related coverage 
programs. This is consistent with the 2016 Rule, which similarly 
prohibited discrimination in health-related insurance and other health-
related coverage under former Sec.  92.207, including in marketing 
practices and benefit design. The 2020 Rule repealed former Sec.  
92.207 in its entirety, stating that an additional or separate section 
on health insurance was not necessary.\426\ Despite removing former 
Sec.  92.207, the preamble to the 2020 Rule stated that OCR would 
continue to investigate discrimination in health insurance, including 
in benefit design.\427\
---------------------------------------------------------------------------

    \426\ 85 FR 37160, 37201 (June 19, 2020).
    \427\ Id. at 37177, 37201.
---------------------------------------------------------------------------

    In rescinding former Sec.  92.207, the 2020 Rule creates a lack of 
clarity for covered entities as to what constitutes prohibited 
discrimination in health insurance and health-related coverage.\428\ 
This uncertainty creates confusion regarding what conduct is prohibited 
and renders Section 1557 less effective at combatting discrimination in 
health insurance and other health-related coverage, resulting in 
greater risk for covered entities and less protection for people who 
need health care and who are protected by Section 1557 against 
discrimination.
---------------------------------------------------------------------------

    \428\ See Valarie K. Blake, Health Care Civil Rights Under 
Medicare for All, 72 Hastings L.J. 773, 800 (2021), https://repository.uchastings.edu/cgi/viewcontent.cgi?article=3925&context=hastings_law_journal (stating 
the 2020 Rule ``eliminated all of the specific guidance on what 
counts as insurance discrimination, leaving the issue to OCR and the 
courts'').
---------------------------------------------------------------------------

    The statutory text of Section 1557 demonstrates Congress' intent to 
apply Section 1557 nondiscrimination requirements to health insurance 
and other health-related coverage where an entity receives Federal 
financial assistance and, therefore, the Department proposes to 
reinstate specific provisions related to nondiscrimination in health 
insurance and other health-related coverage in the Section 1557 rule. 
Robust enforcement of such nondiscrimination requirements for health 
insurance and other health-related coverage practices is critical to 
ensure individuals' ability to receive the health services that they 
need, unencumbered by discriminatory conduct. Such discriminatory 
conduct

[[Page 47869]]

reduces both access to care and the quality of care received on the 
basis of race, color, national origin, sex, age, or disability. The 
Department's proposal to reinstate the provisions is consistent not 
only with the ACA, but with the Administration's mission to enhance the 
health and well-being of all Americans.\429\
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    \429\ Mission Statement, U.S. Dep't of Health & Human Servs., 
https://www.hhs.gov/about/strategic-plan/introduction/index.html#mission (last updated Mar. 28, 2022).
---------------------------------------------------------------------------

    E.O. 14009, ``Strengthening Medicaid and the Affordable Care Act,'' 
states that it is the Administration's policy to ``protect and 
strengthen Medicaid and the ACA and to make high-quality health care 
accessible and affordable for every American.'' \430\ Of particular 
relevance to Section 1557, E.O. 14009 requires agencies to examine 
policies or practices that may undermine protections for people with 
pre-existing conditions under the ACA, may present ``unnecessary 
barriers'' to individuals seeking access to Medicaid or ACA coverage, 
and may reduce the affordability of coverage.\431\ Additionally, E.O. 
14070, ``Continuing To Strengthen Americans' Access to Affordable, 
Quality Health Coverage,'' states that agencies ``. . . shall review 
agency actions to identify ways to continue to expand the availability 
of affordable health coverage, to improve the quality of coverage, to 
strengthen benefits, and to help more Americans enroll in quality 
health coverage.'' \432\ By specifying that health insurance and other 
health-related coverage offered through the Exchanges and Medicaid must 
be provided in a nondiscriminatory manner, proposed Sec.  92.207 would 
strengthen access to health care and prevent unnecessary barriers in 
accessing coverage consistent with E.O. 14009 and E.O. 14070.
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    \430\ 86 FR 7793 (Jan. 28, 2021) (revoking E.O. 13765, 
``Minimizing the Economic Burden of the Patient Protection and 
Affordable Care Act Pending Repeal,'' 82 FR 8351 (Jan. 20, 2017), 
which was cited as a justification for the 2020 Rule).
    \431\ Id. at 7794.
    \432\ 87 FR 20689, 20690 (Apr. 8, 2022).
---------------------------------------------------------------------------

    As discussed previously, historically marginalized communities 
disproportionally suffer from worse health outcomes and higher rates of 
discrimination in accessing health care than other communities.\433\ By 
addressing the prevention of discrimination in health insurance and 
other health-related coverage, proposed Sec.  92.207 also aligns with 
the Administration's goal of achieving health equity for these 
populations.\434\ Adopting proposed Sec.  92.207, particularly 
paragraphs (b)(3)-(5), would establish specific provisions to protect 
gender-diverse individuals from discrimination in health insurance and 
other health-related coverage.
---------------------------------------------------------------------------

    \433\ See discussion supra section II.D. (on advancing health 
equity).
    \434\ See, e.g., E.O. 13985, 86 FR 7009 (2021).
---------------------------------------------------------------------------

    Proposed paragraph (a) provides a general nondiscrimination 
requirement, and proposed paragraph (b) provides specific examples of 
prohibited actions.
    Proposed paragraph (b)(1) specifies that covered entities are 
prohibited from denying, cancelling, limiting, or refusing to issue or 
renew health insurance coverage or other health-related coverage, or 
denying or limiting coverage of a claim, or imposing additional cost 
sharing or other limitations or restrictions on coverage, on the basis 
of race, color, national origin, sex, age, or disability. This language 
is identical to the 2016 Rule and would prohibit health insurance 
issuers and other covered entities \435\ from taking discriminatory 
actions related to coverage.
---------------------------------------------------------------------------

    \435\ A variety of entities may be considered covered entities 
subject to proposed Sec.  92.207, including but not limited to 
health insurance issuers, sponsors of group health plans, Medicare 
Advantage organizations, Medicare Part D plan sponsors, Medicaid 
managed care organizations, pharmacy benefit managers, third party 
administrators (as part of a covered entity's operations when it 
meets the criteria in paragraph (b) of the definition of ``health 
program or activity'' in proposed Sec.  92.4), and the Department. 
For simplicity, we simply refer to ``health insurance issuers'' or 
``issuers'' throughout the preamble, but please note that other 
covered entities may also be subject to the proposed section under 
discussion.
---------------------------------------------------------------------------

    Proposed paragraph (b)(2) prohibits marketing practices or benefit 
designs that discriminate on the basis of race, color, national origin, 
sex, age, or disability. This is consistent with both the 2016 Rule, 
which contained the same regulatory language, as well as the assurance 
in the preamble of the 2020 Rule that OCR will continue to investigate 
discrimination in health insurance or other health coverage benefit 
design, despite the repeal of former Sec.  92.207.\436\ Reinstating 
this provision will provide clarity and notice to covered entities and 
the public that Section 1557 continues to prohibit discriminatory 
marketing practices and benefit designs on the bases specified under 
Section 1557. This provision is independent of other regulations that 
separately prohibit discrimination in health insurance or other health-
related coverage.\437\ While these nondiscrimination requirements 
complement each other, covered entities are required to independently 
comply with all applicable regulations.
---------------------------------------------------------------------------

    \436\ See 85 FR 37177, 377201.
    \437\ See, e.g., 42 CFR 422.100(f)(2)-(3), Sec.  422.110 
(Medicare Advantage); 42 CFR 423.2262(a)(1)(iv) (Part D); 42 CFR 
438.3(d), (f) (Medicaid); 42 CFR 600.405(d) (Basic Health Program); 
45 CFR 147.104(e) (group and individual health insurance markets); 
45 CFR 155.120(c) (Exchanges); 45 CFR 156.125(a)-(b) (essential 
health benefits); 45 CFR 156.200(e), Sec.  156.225(b) (qualified 
health plans).
---------------------------------------------------------------------------

    The terms ``benefit design'' and ``marketing practices'' encompass 
an array of features. To avoid being overly prescriptive or 
unintentionally inconsistent with other departmental regulations,\438\ 
the Department does not propose defining these terms in this rule and 
intends to interpret them broadly. Examples of benefit design features 
include, but are not limited to, coverage, exclusions, and limitations 
of benefits; prescription drug formularies; cost sharing (including 
copays, coinsurance, and deductibles); utilization management 
techniques (such as step therapy and prior authorization); medical 
management standards (including medical necessity standards); provider 
network design; and reimbursement rates to providers and standards for 
provider admission to participate in a network.
---------------------------------------------------------------------------

    \438\ Other departmental and Federal regulations governing 
private health insurance and public health coverage refer to 
``benefit design'' and ``marketing practices.'' See, e.g., 45 CFR 
147.104(e), Sec.  156.20, Sec.  156.125(a) (health insurance 
issuers); 45 CFR 156.110(d), Sec.  156.125(a), Sec.  156.200(b)(3), 
Sec.  156.225(b) (qualified health plans); 45 CFR 156.110(d), Sec.  
156.111(b)(2)(v) (essential health benefits benchmark plans); 42 CFR 
422.100(f)(3) (Medicare Advantage); 42 CFR 422.2260-15 (Medicare 
Part D marketing requirements); 42 CFR 423.882, Sec.  423.894(d) 
(Medicare retiree prescription drug plans); 42 CFR 440.347(e) 
(Medicaid benchmark plans); 42 CFR 600.405 (Basic Health Program); 
29 CFR 2510.3-40(c)(1)(iv)(A) (employee welfare benefit plan under 
Employee Retirement Income Security Act of 1974).
---------------------------------------------------------------------------

    Marketing practices would broadly include, for example, activities 
designed to encourage individuals to participate or enroll in 
particular health plans or certain types of plans, or to discourage 
them from doing so, and activities that steer or attempt to steer 
individuals towards or away from a particular plan or certain types of 
plans.\439\ For example, covered entities that avoid advertising in 
areas populated by a majority of people of color to reduce the

[[Page 47870]]

enrollment of people of color in their plans could violate this 
provision.\440\
---------------------------------------------------------------------------

    \439\ For simplicity and for purposes of this preamble only, we 
use the term ``health plan'' or ``plan'' interchangeably to refer 
generally to health insurance coverage and other health coverage 
that is subject to this proposed rule. As used in this preamble, 
``health plan'' or ``plan'' may include health insurance coverage 
offered in the group and individual markets, group health plans, 
Medicare Advantage plans, Medicare Part D plans, and Medicaid plans 
that are subject to this proposed rule. We do not intend ``health 
plan'' or ``plan'' to be regulatory terms in this proposed 
regulation or to replace any existing or proposed term in Federal 
law.
    \440\ See Sidney D. Watson, Section 1557 of the Affordable Care 
Act: Civil Rights, Health Reform, Race, and Equity, 55 How. L.J. 
855, 868 (2012), https://heinonline.org/HOL/LandingPage?handle=hein.journals/howlj55÷=33&id=&page=.
---------------------------------------------------------------------------

    By clarifying that health insurance and other health-related 
coverage must not employ discriminatory benefit design or marketing 
practices, proposed paragraph (b)(2) would further the ACA's goals of 
expanding access to affordable and quality health care and would be 
consistent with existing departmental regulations governing health 
insurance and other health-related coverage that similarly prohibit 
such discriminatory practices. The ACA prohibits the use of many 
formerly standard health insurance industry practices in many types of 
coverage that resulted in higher costs or denial of coverage or 
benefits for individuals with disabilities and others, including 
practices such as medical underwriting and premium rating \441\ and 
pre-existing condition exclusions.\442\ Its prohibition of 
discrimination in health-related coverage furthers the same goals.
---------------------------------------------------------------------------

    \441\ 42 U.S.C. 300gg (prohibiting discriminatory premium rates 
by limiting rating factors to only include family size, geographic 
rating area, age, and tobacco use); 300gg-1 (requiring guaranteed 
availability of coverage to any individual or employer applying for 
coverage); 300gg-2 (requiring guaranteed renewability of coverage at 
the option of the plan sponsor or individual).
    \442\ 42 U.S.C. 300gg-3.
---------------------------------------------------------------------------

    We acknowledge that covered entities have discretion in designing 
their benefit packages, and we do not require entities to cover any 
particular procedure or treatment. When assessing complaints alleging 
discrimination in benefit design, OCR will evaluate on a case-by-case 
basis whether a particular design feature or coverage requirement is 
discriminatory. Where appropriate, OCR will determine if there is a 
legitimate, nondiscriminatory justification for the particular benefit 
design feature or coverage requirement. This justification cannot be 
pretext for discrimination. We elaborate further about how OCR will 
analyze claims of discrimination in benefit design later in this 
section.\443\ As we articulate in that discussion,\444\ this rule is 
not intended to prohibit covered entities from utilizing 
nondiscriminatory medical management techniques.
---------------------------------------------------------------------------

    \443\ See discussion infra under this section on Benefit Design.
    \444\ See discussion infra under this section on paragraph (c).
---------------------------------------------------------------------------

    Proposed paragraphs (b)(3) through (5) address benefit designs that 
impermissibly limit coverage based on a person's sex at birth, gender 
identity, or gender otherwise recorded. The Department believes it is 
important to address discrimination faced by transgender individuals, 
including nonbinary and gender diverse individuals, in accessing 
coverage of health services.\445\ Discrimination against transgender 
people in health insurance and other health-related coverage remains 
pervasive, especially for individuals who experience intersectional 
discrimination, such as individuals who experience both transphobia and 
racism.\446\ As reported in a 2020 study of self-identified LGBTQ 
adults, 38 percent of transgender respondents--and 52 percent of 
transgender respondents of color--said that they had been denied 
hormone therapy coverage by their health insurer, and 43 percent 
reported being denied coverage for surgery for their transition.\447\
---------------------------------------------------------------------------

    \445\ As noted elsewhere in this preamble, although individuals 
with a gender identity that differs from their sex assigned at birth 
are commonly referred to as transgender, many individuals do not 
identify as such. Instead, some individuals may identify as 
nonbinary or gender diverse, meaning they do not identify with 
traditional binary gender or a single gender. Within these 
provisions, the term ``transgender'' is being used as an umbrella 
term to encompass individuals with transgender, nonbinary, gender 
diverse identities.
    \446\ Patterson, supra note 123, at p. 299.
    \447\ Gruberg, supra note 129, at p. 21; see also James, supra 
note 130, at p. 10 (2016) (25% of respondents with insurance 
reported experiencing insurance discrimination based on their gender 
identity, including being denied gender specific services and care 
not related to gender affirmation).
---------------------------------------------------------------------------

    OCR believes the approach proposed in Sec.  92.207(b)(3) through 
(5), which is similar to provisions in the 2016 Rule, will once again 
prove vital in helping to address discrimination faced by individuals 
whose sex assigned at birth is different from their gender identity in 
accessing coverage of health services, including health services that 
are medically necessary,\448\ and is consistent with the legal 
principle that discrimination on the basis of sex includes 
discrimination on the basis of gender identity.\449\ As discussed 
regarding how the Department will evaluate claims of discrimination 
under proposed Sec.  92.206(b), the Department will look for direct or 
circumstantial evidence of discrimination when considering claims of 
intentional discrimination. Direct evidence may come in the form of an 
express classification (e.g., explicit conditions for the receipt of 
benefits or services based on the sex of an individual) or statements 
from decisionmakers that express discriminatory intent. In the absence 
of such direct evidence, the Department would look for circumstantial 
evidence, including by using the Arlington Heights factors or McDonnell 
Douglas framework.
---------------------------------------------------------------------------

    \448\ The definition of medical necessity can vary. While the 
term ``medical necessity'' is not explicitly defined by CMS statute 
or regulation, Medicare provides coverage for items and services 
that are ``reasonable and necessary for the diagnosis or treatment 
of illness or injury or to improve the functioning of a malformed 
body member.'' 42 U.S.C. 1395y(a)(1)(A). CMS further outlines 
medical necessity requirements for specific services in its various 
Medicare Policy Manuals. See, e.g., Ctrs. for Medicare & Medicaid 
Servs., Medicare Program Integrity Manual, Chapter 6--Medicare 
Contractor Medical Review Guidelines for Specific Services, Sec. 
6.1.4--Medical Review Process, p. 7 (2020), https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c06.pdf 
(stating ``[c]linical documentation that supports medical necessity 
may be expected to include: physician orders for care and 
treatments, medical diagnoses, rehabilitation diagnosis (as 
appropriate), past medical history, progress notes that describe the 
beneficiary's response to treatments and his/her physical/mental 
status, lab and other test results, and other documentation 
supporting the beneficiary's need for the skilled services being 
provided in the SNF.''). CMS defines ``medically necessary'' in the 
Summary of Benefits and Coverage (SBC) Template Uniform Glossary as 
``[h]ealth care services or supplies needed to prevent, diagnose, or 
treat an illness, injury, condition, disease, or its symptoms, 
including habilitation, and that meet accepted standards of 
medicine.'' Ctrs. for Medicare & Medicaid Servs., Glossary of Health 
Coverage and Medical Terms, p. 3 (2020), https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/Uniform-Glossary-01-2020.pdf. The American Medical Association defines 
``medical necessity'' as ``[h]ealth care services or products that a 
prudent physician would provide to a patient for the purpose of 
preventing, diagnosing or treating an illness, injury, disease or 
its symptoms in a manner that is: (a) in accordance with generally 
accepted standards of medical practice; (b) clinically appropriate 
in terms of type, frequency, extent, site, and duration; and (c) not 
primarily for the economic benefit of the health plans and 
purchasers or for the convenience of the patient, treating 
physician, or other health care provider.'' Am. Med. Ass'n, 
Definitions of ``Screening'' and ``Medical Necessity'' H-320.953 
(2016), https://policysearch.ama-assn.org/policyfinder/detail/H-320.953?uri=%2FAMADoc%2FHOD.xml-0-2625.xml; see also WPATH 
Standards, supra note 139. While this regulation and preamble 
primarily use the term ``medical necessity,'' many covered entities 
also consider the related concepts of ``medical appropriateness'' or 
``clinical appropriateness'' in making decisions about care and 
coverage, as can be seen in the definitions in this footnote. For 
the purposes of this rule, any such decisions must be 
nondiscriminatory, regardless of the label used.
    \449\ Bostock v. Clayton Cty., 140 S. Ct. 1731 (2020).
---------------------------------------------------------------------------

    Proposed paragraph (b)(3) clarifies that it is prohibited 
discrimination to deny or limit coverage, deny or limit coverage of a 
claim, or impose additional cost sharing or other limitations or 
restrictions on coverage to an individual based upon the individual's 
sex at birth, gender identity, or gender otherwise recorded.\450\ The 
2016 Rule provided a

[[Page 47871]]

more specific prohibition, which provided that to deny or limit 
coverage, deny or limit coverage of a claim, or impose additional cost 
sharing or other limitations or restrictions on any health service that 
is ordinarily or exclusively available to persons of one sex when the 
denial or limitation is due to the fact that the individual's sex 
assigned at birth, gender identity, or gender otherwise recorded by the 
covered entity, is different from the one to which such services are 
ordinarily or exclusively available was prohibited sex discrimination. 
Such discrimination is similarly prohibited under this provision.
---------------------------------------------------------------------------

    \450\ Under the general nondiscrimination requirement in 
proposed Sec.  92.207(a), a covered entity would be barred from 
denying coverage of any claim (not just for sex-specific services) 
on the basis that the enrollee's sex assigned at birth is different 
than their gender identity.
---------------------------------------------------------------------------

    Although covered health plans routinely cover sex-specific 
preventive care services (e.g., prostate and cervical cancer 
screenings) for cisgender individuals, some transgender individuals, 
due to their gender identity or because they are not enrolled in their 
health plan consistent with their sex assigned at birth, are denied 
coverage parity for the same preventive health services.\451\ For 
example, under proposed Sec.  92.207(b)(3), a health insurance issuer 
may not deny coverage for a transgender man who requires a mammogram 
screening, based on the fact that he is enrolled in the health plan as 
a man.\452\ Nor could they deny him coverage of a uterine biopsy to 
identify potential uterine cancer because he is enrolled in the health 
plan as a man. Distinct from Section 1557, we remind covered entities 
that section 2713 of the Public Health Service Act (``PHS Act'') and 
its implementing regulations generally require coverage for certain 
recommended preventive health services without imposing cost-sharing 
requirements.\453\
---------------------------------------------------------------------------

    \451\ Providers and issuers frequently formulate incorrect 
assumptions about transgender and gender non-conforming individual's 
bodies when assessing medical necessity for sex-specific preventive 
care. For example, cervical cancer risks for transgender men are 
sometimes erroneously assumed by providers to be lower than for 
cisgender women. Only 64% of respondents who retained a uterus were 
told by their providers to get screened for cervical cancer. See 
Mandi L. Pratt-Chapman & Adam R. Ward, Provider Recommendations Are 
Associated with Cancer Screening of Transgender and Gender-
Nonconforming People: A Cross-Sectional Urban Survey, 5 Transgender 
Health 80, 83 (2020), https://www.liebertpub.com/doi/10.1089/trgh.2019.0083.
    \452\ See also FAQs about Affordable Care Act Implementation 
(Part XXVI), Q5 (May 11, 2015) (stating ``[w]hether a sex-specific 
recommended preventive service that is required to be covered 
without cost sharing under PHS Act section 2713 and its implementing 
regulations is medically appropriate for a particular individual is 
determined by the individual's attending provider. Where an 
attending provider determines that a recommended preventive service 
is medically appropriate for the individual--such as, for example, 
providing a mammogram or pap smear for a transgender man who has 
residual breast tissue or an intact cervix--and the individual 
otherwise satisfies the criteria in the relevant recommendation or 
guideline as well as all other applicable coverage requirements, the 
plan or issuer must provide coverage for the recommended preventive 
service, without cost sharing, regardless of sex assigned at birth, 
gender identity, or gender of the individual otherwise recorded by 
the plan or issuer''), available at https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/aca_implementation_faqs26.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf.
    \453\ 45 CFR 147.130; 26 CFR 54.9815-2713; 29 CFR 2590.715-2713.
---------------------------------------------------------------------------

    We clarify that Section 1557 does not prohibit a covered entity 
from inquiring about an individual's relevant medical history and 
physical traits when necessary to determine the medical necessity of a 
health service for that individual. For example, in the same way a 
medical professional would not be prohibited from treating a pregnant 
transgender man for pregnancy,\454\ a health insurance issuer 
(including its third party administrator activities, if applicable) may 
confirm that treatment related to pregnancy is medically necessary for 
an enrollee whose recorded sex is male.
---------------------------------------------------------------------------

    \454\ See discussion supra proposed Sec.  92.206(b)(3), (c).
---------------------------------------------------------------------------

    We seek comment on this provision, including whether it 
sufficiently addresses the challenges transgender and gender 
nonconforming individuals are experiencing when seeking to access to 
medically necessary care due to a discordance between their sex 
assigned at birth and their sex as recorded by their issuer.
    The Department, in paragraph (b)(4), proposes to prohibit a covered 
entity from having or implementing a categorical coverage exclusion or 
limitation for all health services related to gender transition or 
other gender-affirming care.\455\ This is consistent with the 2016 Rule 
at former Sec.  92.207(b)(4), modified to include gender-affirming 
care. Some health plans continue to have a categorical ban on all 
gender-affirming care for transgender individuals as not medically 
indicated and as improper care to treat gender dysphoria, regardless of 
whether such care has been prescribed by a health care professional and 
despite widespread professional consensus to the contrary.\456\
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    \455\ As noted in the discussion of Sec.  92.206 above, this 
preamble uses the terms ``gender transition'' and ``gender 
affirmation'' interchangeably in discussing the range of care that 
transgender individuals (including those who identify using other 
terms, for example, nonbinary or gender nonconforming) may seek to 
treat gender dysphoria and support gender transition or affirmation. 
Because insurance coverage provisions and medical-necessity 
determinations more often use the term gender transition, within 
these provisions, the term gender affirmation encompasses gender 
transition, that is the terminology used in the text of the 
regulation. The use of the term ``gender transition'' in the 
regulation, however, is not intended to convey a narrower meaning 
than the term ``gender affirmation.''
    \456\ See Boyden v. Conlin, 341 F. Supp. 3d 979, 987 (W.D. Wis. 
2018) (noting that the American Medical Association, the American 
Psychiatric Association, the American Psychological Association, the 
American Counseling Association, the American Psychoanalytic 
Association, and the World Professional Association of Transgender 
Health, all recognize the medical necessity of transition related 
care for transgender people with gender dysphoria); see also Flack 
v. Wisconsin Dep't of Health Servs., 395 F. Supp. 3d 1001, 1005 
(W.D. Wis. 2019) (``For appropriate candidates, however, major 
medical organizations, including the American Medical Association, 
Endocrine Society, and American Psychiatric Association view gender-
confirming surgeries as medically accepted, safe, and effective 
treatments for severe gender dysphoria.'').
---------------------------------------------------------------------------

    Such categorical exclusions in covered plans both facially deny 
transgender individuals coverage access based on their gender identity 
and result in more than de minimis harm to the individuals; therefore 
they are prohibited discrimination on the basis of sex.\457\ A covered 
entity's denial of coverage solely on the basis of one's sex assigned 
at birth--i.e., if the individual was assigned a different sex at 
birth, such care coverage would not be denied--constitutes disparate 
treatment and is prohibited under this proposed rule because 
transgender individuals are the only individuals who seek transition-
related care.\458\ Additionally, a recent district court opinion found 
that ``it is impossible to determine whether a particular treatment is 
connected to'' gender affirming care without comparing [the person's] 
``sex before the treatment to how it might be impacted by the 
treatment.'' \459\
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    \457\ See e.g., Flack, 395 F. Supp. at 1001 (striking down 
Wisconsin Medicaid exclusion under Section 1557, Availability and 
Comparability Provisions of the Medicaid Act, and Equal Protection 
Clause of the U.S. Constitution); Cruz v. Zucker, 195 F. Supp. 3d 
554, 571 (S.D.N.Y. 2016), on reconsideration, 218 F. Supp. 3d 246 
(S.D.N.Y. 2016), appeal withdrawn (Dec. 30, 2016) (finding that a 
categorical ban on medically necessary treatments for a specific 
diagnosis, gender dysphoria, violates the Federal Medicaid Act's 
Availability Provision).
    \458\ See U.S. Dep't of Justice, Brief for the United States as 
Amicus Curiae in Support of Plaintiffs-Appellees, Brandt v. 
Rutledge, No. 21-2875, 11 (8th Cir. Aug. 23, 2021) (``Only persons 
who are transgender would seek these ``gender transition 
procedures,'' because only their gender identity differs from their 
``biological sex'' (as defined by the Act).'').
    \459\ Kadel v. Folwell, No. 1:10-cv-00272, 2022 WL 2106270, at 
*19 (M.D.N.C. June 10, 2022).
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    Nonetheless, some health plans still have broad exclusions of 
coverage for care related to gender dysphoria or associated with gender 
affirmation.\460\
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    \460\ See Out2Enroll, Summary of Findings: 2021 Marketplace Plan 
Compliance with Section 1557, p. 1 (2021), https://out2enroll.org/wp-content/uploads/2020/11/Report-on-Trans-Exclusions-in-2021-Marketplace-Plans.pdf (listing Bright Health, Ala., Ariz., Ill., 
N.C., Neb., Okla., S.C., Tenn.; United Healthcare, Ariz., Okla., 
Tenn.; Alliant, Ga.; Mercy Care, Ill. as offering plans that include 
categorical exclusions for all transition-related care). Until 2020, 
the percentage of issuers that affirmatively stated that some or all 
gender-affirming care for transgender individuals is covered had 
increased each year. There continues to be a presumption among some 
issuers, however, that except under narrow circumstances, such care 
is not medically necessary and therefore not covered. Id.

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[[Page 47872]]

    The Department proposes in paragraph (b)(5) to ensure that a 
covered entity does not impose discriminatory limits on coverage for 
specific health services related to gender transition or other gender 
affirming care, which would generally be the case if such limits are 
not applied when those same health services are not related to gender 
transition. The limits that could constitute discriminatory conduct 
prohibited by this paragraph include denying or limiting coverage, 
denying or limiting a claim for coverage, imposing additional cost 
sharing, or other limitations or restrictions on coverage on the basis 
of gender identity. For example, a health plan that excludes ``coverage 
for surgery, such as a vaginoplasty and mammoplasty'' for any enrollee 
whose sex assigned at birth is male ``while providing coverage for such 
medically necessary surgery'' for enrollees whose sex assigned at birth 
is female ``is discriminatory on its face.'' \461\ Exclusions that 
limit care related to one class of gender transition or other gender-
affirming care may also violate this provision.\462\
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    \461\ Fletcher v. Alaska, 443 F. Supp. 3d 1024, 1031 (D. Alaska 
2020) (Title VII); see also Kadel, No. 1:19-cv-00272, 2022 WL 
2106270, at *28-*29 (Title VII).
    \462\ See, e.g., Conn. Comm'n on Human Rights & Opportunities, 
Declaratory Ruling on Petition Regarding Health Insurers' 
Categorization of Certain Gender-Confirming Procedures as Cosmetic 
(Apr. 17, 2020), https://www.glad.org/wp-content/uploads/2020/04/Dec-Rule_04152020.pdf (discussing how depending on the policy or 
plan, the categorical exclusion of certain procedures for gender 
dysphoria discriminates on the basis of sex by denying equal access 
to certain medical procedures based on an individual's assigned sex. 
As such, a blanket policy exclusion for gender transition and 
related services is prohibited.). See also Challenging Insurance 
Exclusions for Gender Affirming Medical Care, GLBTQ Legal Advocates 
& Defenders, https://www.glad.org/cases/challenging-insurance-exclusions-for-gender-affirming-medical-care (last updated April 23, 
2020).
---------------------------------------------------------------------------

    The proposed paragraphs (b)(3) through (5) do not: require covered 
entities to cover specific procedures or treatments for gender 
transition or other gender-affirming care that they do not otherwise 
cover under the plan.
    In proposed paragraph (b)(6), the Department proposes an 
integration provision that prohibits covered entities from having or 
implementing a benefit design that does not provide or administer 
health insurance coverage or other health-related coverage in the most 
integrated setting appropriate to the needs of qualified individuals 
with disabilities.
    The Department's existing Section 504 regulation includes an 
integration provision at 45 CFR 84.4(b)(2), which would be incorporated 
into Section 1557 at proposed Sec.  92.101(b)(1). Section 504's 
integration provision provides that covered entities must provide 
services and programs in the most integrated setting appropriate to the 
needs of the qualified individual with a disability (referred to as the 
``integration mandate''). The most integrated setting appropriate to 
the needs of an individual with a disability means a setting that 
enables individuals with disabilities to interact with individuals 
without disabilities to the fullest extent possible.\463\ In 1999, the 
Supreme Court held in Olmstead v. L.C.\464\ that the ADA's integration 
mandate prohibits the unjustified segregation of individuals with 
disabilities. Section 504's integration mandate creates the same set of 
obligations for entities that receive Federal financial assistance. In 
addition, health programs and activities must 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 making the modifications would 
fundamentally alter the nature of the service, program, or 
activity.\465\
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    \463\ 28 CFR pt. 35, app. B (2011) (addressing Sec.  35.130).
    \464\ Olmstead v. L.C., 527 U.S. 581 (1999).
    \465\ 28 CFR 35.130(b)(7)(i); 45 CFR 92.105; see also Olmstead, 
527 U.S. at 603-07.
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    Covered entities providing or administering health insurance or 
other health-related coverage are subject to the integration 
requirements under Section 504. Despite these obligations, covered 
entities may not be taking these requirements into account in their 
health-related coverage benefit design.\466\ For example, literature 
shows that variation in benefit design, including reimbursement rates, 
impact whether individuals with disabilities exiting hospitals enter 
institutional, congregate, or otherwise segregated settings for post-
acute care services, with payment practices and provider network design 
playing a greater role than clinical characteristics in some 
instances.\467\
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    \466\ See Letter from the Bazelon Center for Mental Health Law 
to Robinsue Frohboese, Acting Dir., Office for Civil Rights, U.S. 
Dep't of Health & Human Servs. (June 7, 2021) (discussing how 
benefit design decisions can result in needless segregation of 
people with disabilities). The letter will be attached to the docket 
of this proposed rule as a supplemental material at 
federalregister.gov.
    \467\ Medicare Advantage and commercial health plan benefit 
designs that impose beneficiary cost-sharing, referral requirements 
or prior authorization requirements can restrict access to home 
health services. See, e.g., Lacey Loomer et al., Comparing Receipt 
of Prescribed Post-Acute Home Health Care Between Medicare Advantage 
and Traditional Medicare Beneficiaries: An Observational Study, 36 
J. Gen. Intern. Med. 2323 (2020), https://link.springer.com/content/pdf/10.1007/s11606-020-06282-3.pdf (finding that receipt of post-
acute home health care was lower for Medicare Advantage enrollees 
compared with traditional Medicare enrollees, and that among 
Medicare Advantage enrollees, HMO plans with home health utilization 
restrictions (i.e., cost sharing, pre-authorization, referral 
requirements) were less likely to receive prescribed home health); 
Laura Skopec et al., Home Health Use in Medicare Advantage Compared 
to Use in Traditional Medicare, 39 Health Affairs 1072 (2019), 
https://www.healthaffairs.org/doi/10.1377/hlthaff.2019.01091 
(finding Medicare Advantage enrollees were less likely to use home 
health care than traditional Medicare enrollees were and had shorter 
average home health spells, and suggesting that these differences in 
use and length of spell may be related to differences in how 
Medicare Advantage plans manage and pay for home health care); Scott 
E. Regenbogen et al., Spending on Postacute Care After 
Hospitalization in Commercial Insurance and Medicare Around Age 
Sixty-five, 38 Health Affairs 1505 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7795720/pdf/nihms-1659826.pdf 
(finding that the benefit design practices of commercial insurers 
result in substantially less access to home health services for 
post-acute care than that which is available in fee-for-service 
Medicare). Such reductions in home health use do not necessarily 
violate the integration mandate if issuers simply reduce unnecessary 
service-provision without increasing risk of institutionalization 
and apply standard medical management techniques in a 
nondiscriminatory fashion as permitted under Section 1557 (proposed 
Sec.  92.207(c)). However, a benefit design restricting access to 
home health services may raise concerns under the integration 
mandate if it leads to a serious risk of unjustified or unnecessary 
institutionalization of people with disabilities. Benefit design can 
also reduce the risk of institutionalization, including long-term 
institutionalization. See, e.g., Amit Kumar et al., Comparing Post-
Acute Rehabilitation Use, Length of Stay, and Outcomes Experienced 
by Medicare Fee-for-Service and Medicare Advantage Beneficiaries 
with Hip Fracture in the United States: A Secondary Analysis of 
Administrative Data, 15 PLoS Med., June 6, 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019094/pdf/pmed.1002592.pdf 
(finding that benefit design and care management practices adopted 
by Medicare Advantage plans resulted in a lower risk of long-term 
institutionalization within a nursing home and a higher rate of 
successful discharge to the community relative to those used in fee-
for-service Medicare).
---------------------------------------------------------------------------

    OCR's intent in articulating this provision is to clarify that a 
benefit design that results in the unjustified segregation or 
institutionalization of qualified individuals with disabilities or that 
place such individuals at serious risk of unjustified 
institutionalization or segregation is prohibited disability 
discrimination.
    For instance, benefit designs raising integration concerns may 
include those that: limit or deny access to services in

[[Page 47873]]

the most integrated setting while making comparable services available 
in segregated or institutional settings; place additional terms and 
conditions on the receipt of certain benefits in integrated settings 
that are not in place within segregated or institutional settings; 
impose more restrictive rules or requirements for coverage for services 
in community-based settings than those applied to coverage for services 
in segregated or institutional settings; or set better reimbursement 
rates for a service or item for individuals in segregated settings than 
for individuals in community settings.\468\ For example, an issuer 
covering a service or benefit (such as personal care or durable medical 
equipment) for individuals in institutional settings, but not covering 
the same service or benefit for individuals living in their own homes 
or in other community settings would violate this provision if the 
difference in coverage resulted in the unnecessary segregation of 
individuals with disabilities, or a serious risk of such segregation, 
unless it could show that modifications (to the coverage rule or 
policy) would fundamentally alter the nature of the service, program, 
or activity. We note that a state Medicaid program would generally not 
be required to provide a new benefit, because that would fundamentally 
alter the nature of the program. However, to the extent that a benefit, 
including an optional benefit, is already provided as part of the 
state's program, it must be offered in a manner that does not 
incentivize institutional services over community services.\469\
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    \468\ See Letter from the Bazelon Ctr. for Mental Health Law, 
supra note 466 (discussing how benefit design decisions can result 
in needless segregation of people with disabilities). The letter 
will be attached to the docket of this proposed rule as a 
supplemental material at federalregister.gov.
    \469\ See, e.g., Radaszewski ex rel Radaszewski v. Maram, 383 
F.3d 599, 611 (7th Cir. 2004) (``Although a state is not obliged to 
create entirely new services or to otherwise alter the substance of 
the care that it provides to Medicaid recipients . . . the 
integration mandate may well require the State to make reasonable 
modifications to the form of existing services in order to adapt 
them to community-integrated settings.'')
---------------------------------------------------------------------------

    This provision will also be interpreted to apply both to 
circumstances where individuals with disabilities are unnecessarily 
segregated or institutionalized as a result of benefit design features, 
and circumstances where the benefit design places individuals with 
disabilities at serious risk of placement within an institution, 
congregate care setting, or other segregated settings through the 
coverage of or payment for services offered or provided in integrated 
settings relative to segregated ones, or through funding or service 
implementation practices within a benefit design set or administered by 
a covered entity that result in such a risk.\470\ For example, a 
Medicare Advantage plan that requires prior authorization or step 
therapy to receive a medication in the community, but not in a skilled 
nursing facility, would be in violation of this provision if the 
discrepancy resulted in unnecessary segregation or a serious risk of 
unnecessary segregation and the distinction was not clinically 
appropriate. Similarly, if the plan relied on a pharmacy benefit 
manager (PBM) to administer prescription drug benefits, and the PBM 
employed utilization management techniques in the community that 
created greater barriers to accessing medication than in an 
institutional setting, the PBM may be in violation of this provision if 
the PBM is subject to this part.
---------------------------------------------------------------------------

    \470\ U.S. Dep't of Justice, Civil Rights Div., Statement of the 
Department of Justice on Enforcement of the Integration Mandate of 
Title II of the Americans with Disabilities Act and Olmstead v. L.C. 
(June 22, 2011), https://www.ada.gov/olmstead/q&a_olmstead.htm. See 
also Fisher v. Oklahoma Health Care Authority, 355 F.3d 1175 (10th 
Cir. 2003) (finding that it violates the integration mandate to 
restrict the number of prescription medications available to 
individuals enrolled in Medicaid home and community-based services 
to five per month while not applying such a cap to individuals in 
institutional settings); see also Pashby v. Delia, 709 F.3d 307 (4th 
Cir. 2021).
---------------------------------------------------------------------------

    This provision encompasses both the direct design of a benefit 
offered by a covered entity and indirect mechanisms that affect the 
implementation of a benefit design within the covered entity's control, 
such as utilization management practices, provider reimbursement, 
contracting out to third party-contractors such as PBMs, and quality 
measurement and incentive systems. Covered entities designing contracts 
with managed care organizations, PBMs, or other third-party entities 
taking on financial risk for the delivery of health services should 
carefully scrutinize their capitation, reimbursement, quality 
measurement, and incentive structures to ensure that they do not result 
in the unjustified segregation of individuals with disabilities or 
place individuals with disabilities at serious risk of unjustified 
segregation.
    OCR seeks comment on the scope and nature of the benefit design 
features that result in unjustified segregation or institutionalization 
of qualified individuals with disabilities or place such individuals at 
serious risk of unjustified institutionalization or segregation. We are 
interested in feedback on the application of the integration mandate to 
a wide variety of health services and are particularly interested in 
comments on the application of the integration mandate to coverage of 
post-acute services, mental health services, and other services 
commonly provided by non-state payers (i.e., health insurance issuers, 
self-insured group health plans, and other payers). We are also 
interested in feedback on the application of the integration mandate to 
the Medicaid program and its statutory framework at Title XIX of the 
Social Security Act. Specifically, we request input on how state 
Medicaid agencies are able to achieve compliance with the integration 
mandate through benefit design, such as through reimbursement, service 
scope, and service authorization that do not incentivize institutional 
services over community services. In addition, we request input on the 
amount of time needed to reach compliance with needed benefit design 
modifications.
    Proposed paragraph (c) states that nothing in this section requires 
the coverage of any health service where the covered entity has a 
legitimate, nondiscriminatory reason for determining that such health 
service fails to meet applicable coverage requirements, such as medical 
necessity requirements, in an individual case.
    Covered entities may employ reasonable medical management 
techniques, including medical necessity standards,\471\ for determining 
coverage of a particular treatment based on whether it is medically 
appropriate under current generally accepted standards of care for an 
individual or whether the treatment is experimental or cosmetic, as 
long as the medical management standards are not discriminatory and are 
not otherwise prohibited under other applicable Federal and state law. 
When developed and used appropriately in a nondiscriminatory manner, 
medical necessity guidelines prevent unnecessary costs to covered 
entities and protect the safety of enrollees by ensuring that the 
requested treatment is safe and clinically appropriate for the 
particular enrollee. This determination involves a medical review of 
the patient's condition and the clinical appropriateness of the 
requested treatment in accordance with the covered entity's medical 
necessity guidelines. Such guidelines should be

[[Page 47874]]

applied in a neutral manner and could raise concerns under this 
proposed rule if the guidelines establish more restrictive requirements 
for certain diseases or conditions without justification, for example, 
if the guidelines require a separate, more stringent review process 
only for mental health services.\472\
---------------------------------------------------------------------------

    \471\ See supra note 448 discussing definitions of medical 
necessity. See also 45 CFR 156.125(c) (CMS regulation prohibiting 
discrimination in essential health benefits stating that ``nothing 
in this section shall be construed to prevent an issuer from 
appropriately utilizing reasonable medical management techniques'').
    \472\ We note this practice may also violate the rules regarding 
non-quantitative treatment limitations applicable to group health 
plans and health insurance issuers under the Paul Wellstone and Pete 
Domenici Mental Health Parity and Addiction Equity Act of 2008 
(MHPAEA), Public Law 110-343, as amended, which is distinct from 
Section 1557 and not enforced by OCR. See 42 U.S.C. 300gg-26 (HHS); 
29 U.S.C. 1185a (Department of Labor); 26 U.S.C. 9812 (Department of 
Treasury), and implementing regulations at 45 CFR 146.136, 29 CFR 
2590.712, and 26 CFR 54.9812-1, respectively; see also U.S. Dep't of 
Labor, U.S. Dep't of Health & Human Servs., U.S. Dep't of the 
Treasury, 2022 MHPAEA Report To Congress: Realizing Parity, Reducing 
Stigma, and Raising Awareness: Increasing Access to Mental Health 
and Substance Use Disorder Coverage (2022), https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf; U.S. Dep't of Labor, Self-Compliance tool for 
the Mental Health Parity and Addiction Equity Act (MHPAEA), p. 38 
(2020), https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf.
---------------------------------------------------------------------------

    When OCR receives a complaint alleging that a denial of coverage 
was based upon prohibited discrimination rather than on a 
nondiscriminatory assessment of medical necessity, consistent with 
longstanding OCR practice, OCR will not conduct a general review of the 
medical judgment behind the denial for a specific individual. Rather, 
OCR's review will focus on the narrow question of whether the rationale 
for the denial was tainted by impermissible discriminatory 
considerations. Thus, OCR may require a covered entity to provide its 
medical necessity standards or guidelines; the clinical, evidence-based 
criteria or guidelines \473\ relied upon to make the medical necessity 
determination; and the medical substantiation for the medical necessity 
determination.
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    \473\ See Patient Protection and Affordable Care Act; HHS Notice 
of Benefit and Payment Parameters for 2023, 87 FR 27208, 27296-300 
(May 6, 2022) (discussing newly promulgated 45 CFR 156.125(a), which 
states ``[a] non-discriminatory benefit design that provides 
[essential health benefits] is one that is clinically-based'').
---------------------------------------------------------------------------

    Claims of medical necessity that are not based upon genuine medical 
judgments will be considered evidence of pretext for discrimination. 
For example, issuers have historically excluded services related to 
gender-affirming care for transgender people as experimental or 
cosmetic (and therefore not medically necessary).\474\ Characterizing 
this care as experimental or cosmetic would be considered evidence of 
pretext because this characterization is not based on current standards 
of medical care.\475\ Such exclusions are a form of disparate treatment 
discrimination, as they distinguish between care that is covered and 
care that is not solely by whether such care is provided as gender-
affirming care for transgender people. Thus, categorical exclusions for 
gender-affirming care for transgender people that provide the basis for 
the exclusion as ``experimental'' would result in prohibited 
discrimination on the basis of sex. This is not to say that issuers 
must cover all services related to gender-affirming care for 
transgender individuals--or all medically necessary services generally. 
Issuers retain flexibility in designing their benefit packages, and 
this proposed rule would not require issuers to cover any particular 
benefit or to cover all medically necessary services. It does require, 
however, that issuers apply standards in a consistent, neutral, 
nondiscriminatory manner that does not limit or deny services to 
individuals based on a protected basis.
---------------------------------------------------------------------------

    \474\ See discussion supra under this section on paragraphs 
(b)(3) through (4).
    \475\ Id.
---------------------------------------------------------------------------

    Proposed paragraph (c) also would not prohibit a covered entity 
from engaging in utilization management techniques applied in a 
neutral, nondiscriminatory manner. Utilization management techniques 
include prior authorization,\476\ step therapy (or ``fail-
first''),\477\ and durational or quantity limits.\478\ Utilization 
management controls, designed to control costs and ensure the 
clinically appropriate use of services,\479\ are standard industry 
practices \480\ that are permitted under Section 1557 as long as they 
are applied in a neutral, nondiscriminatory manner and are not 
otherwise prohibited under other applicable Federal and state law.\481\ 
Excessive use or administration of utilization management tools that 
target a particular condition that could be considered a disability or 
other prohibited basis could violate Section 1557.\482\ For example, 
prescription drug formularies that place utilization management 
controls on most or all drugs that treat a particular condition 
regardless of their costs without placing similar utilization 
management controls on most or all drugs used to treat other conditions 
may be discriminatory under this section. Similarly, benefit designs 
that place utilization management controls on most or all services that 
treat a particular disease or condition but not others may raise 
concerns of discrimination. Where there is an alleged discriminatory 
practice or action, the covered entity would be expected to provide a 
legitimate, nondiscriminatory reason, based on clinical evidence, for 
the practice.
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    \476\ Medicare defines ``prior authorization'' as ``the process 
through which a request for provisional affirmation of coverage is 
submitted to CMS or its contractors for review before the service is 
provided to the beneficiary and before the claim is submitted for 
processing.'' 42 CFR 419.81 (Medicare definition of prior 
authorization for hospital outpatient department services). See also 
Ctrs. for Medicare & Medicaid Servs., Prior Authorization Process 
for Certain Hospital Outpatient Department (OPD) Services Frequently 
Asked Questions (FAQs), Q1 (Dec. 27, 2021), https://www.cms.gov/files/document/opd-frequently-asked-questions.pdf.
    \477\ Medicare defines ``step therapy'' for the Medicare 
Advantage Program as a ``utilization management policy for coverage 
of drugs that begins medication for a medical condition with the 
most preferred or cost effective drug therapy and progresses to 
other drug therapies if medically necessary.'' 42 CFR 422.2.
    \478\ Durational or quantity limits place limits on the 
frequency or number of benefits to be provided, such as limiting 
therapy visits to once per week or limiting prescription drug 
coverage to a 30-day supply of a medication.
    \479\ See, e.g., Ctrs. for Medicare & Medicaid Servs., Prior 
Authorization Process for Certain Hospital Outpatient Department 
(OPD) Services Frequently Asked Questions (FAQs), Q1 (Dec. 27, 
2021), https://www.cms.gov/files/document/opd-frequently-asked-questions.pdf (explaining prior authorization ``ensures that 
Medicare beneficiaries continue to receive medically necessary care 
while protecting the Medicare Trust Funds from unnecessary increases 
in the volume of covered services and improper payments'' and 
``helps to make sure that applicable coverage, payment, and coding 
requirements are met before services are rendered while ensuring 
access to and quality of care'').
    \480\ See generally 42 U.S.C. 18120(1) (stating 
``[n]otwithstanding any other provision in the [ACA], nothing in 
such Act (or an amendment made by such Act) shall be construed to 
(1) prohibit (or authorize the Secretary of Health and Human 
Services to promulgate regulations that prohibit) a group health 
plan or health insurance issuer from carrying out utilization 
management techniques that are commonly used as of March 23, 
2010'').
    \481\ We note that, similar to medical necessity, discussed 
previously, these practices would generally be subject to the rules 
regarding non-quantitative treatment limitations applicable to group 
health plans and health insurance issuers, with respect to medical/
surgical benefits and mental health and substance use disorder 
benefits, under MHPAEA, see supra note 472.
    \482\ See generally Stacey L. Worthy et al., Now or Never: The 
Urgent Need for Action Against Unfair Coverage Denials for Quality 
Health Care, 48 Loy. U. Chi. L.J. 1041 (2017), https://lawecommons.luc.edu/luclj/vol48/iss4/8/.
---------------------------------------------------------------------------

    Finally, the Department proposes Sec.  92.207(d) to explain that 
the enumeration of specific forms of discrimination in paragraph (b) 
does not limit the general applicability of the prohibition in 
paragraph (a) of this section.

Benefit Design

    As discussed when addressing the requirements of proposed paragraph 
(b), OCR will apply basic nondiscrimination

[[Page 47875]]

principles to the facts of the particular plan or coverage when 
analyzing allegations of discrimination under this section to determine 
if the challenged action is unlawful. Due to the fact-intensive nature 
of the analysis necessary to determine whether a particular benefit 
design is discriminatory under this section, we decline to include 
examples of per se discriminatory benefit design features in the 
proposed rule (other than categorical exclusions of all health services 
related to gender transition under proposed paragraph (b)(4), which, as 
discussed above, impermissibly single out an entire category of 
services based on an individual's gender identity).\483\ However, we 
provide additional discussion here to demonstrate how OCR will approach 
investigations related to allegedly discriminatory benefit design.
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    \483\ For examples of presumptively discriminatory benefit 
designs under CMS' essential health benefits nondiscrimination 
regulations applicable to non-grandfathered health insurance 
coverage in the individual and small group markets, see Patient 
Protection and Affordable Care Act; HHS Notice of Benefit and 
Payment Parameters for 2023, 87 FR 27208, 27301-05 (May 6, 2022) 
(providing the following illustrative examples of presumptively 
discriminatory practices under CMS' essential health benefits 
nondiscrimination regulations: (1) limitation on hearing aid 
coverage based on age; (2) autism spectrum disorder coverage 
limitations based on age; (3) age limits for infertility treatment 
coverage when treatment is clinically effective for the age group; 
(4) limitation on foot care coverage based on diagnosis (whether 
diabetes or another underlying medical condition); and (5) access to 
prescription drugs for chronic health conditions (adverse tiering)). 
We note these regulations are enforced by CMS and are distinct from 
Section 1557 and other civil rights laws enforced by OCR.
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    Consistent with general principles in civil rights law, covered 
entities will have the opportunity to articulate a legitimate, 
nondiscriminatory justification for an alleged discriminatory action or 
practice. OCR will scrutinize the justification to ensure it is not a 
pretext for discrimination. When articulating a justification for a 
challenged action or practice that relies upon medical standards or 
guidelines, covered entities should be mindful that such standards and 
guidelines may be subject to additional scrutiny if they are not based 
on clinical, evidence-based criteria or guidelines.
    As discussed in detail later in this section,\484\ we propose to 
apply this part to all the operations of a covered entity that is 
principally engaged in the provision or administration of health 
programs or activities as described in paragraph (a) of the proposed 
definition of ``health program or activity,'' including a health 
insurance issuer's excepted benefits and short-term limited duration 
insurance products. Given the unique nature of these products, which 
are generally exempt from complying with any of the ACA's market 
reforms, we provide further analysis on how OCR proposes to investigate 
potential claims of discrimination challenging benefit design features 
in these products. OCR will consider the nature, scope, and contours of 
the specific plan at issue, and will evaluate on a case-by-case basis 
an alleged discriminatory design feature in light of the entity's 
stated coverage parameters.\485\ Further, as discussed throughout this 
section, covered entities have the opportunity to articulate a 
legitimate, nondiscriminatory basis for their challenged action or 
practice.
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    \484\ See discussion infra under this section on Scope of 
Application and Application to Excepted Benefits and Short-Term 
Limited Duration Insurance.
    \485\ Cf. Easley by Easley v. Snider, 36 F.3d 297, 301-05 (3d 
Cir. 1994) (examining the ``essential nature of the program'' as 
intended by the state when determining that a state's Attendant Care 
Program did not discriminate against individuals with mental 
disabilities under the ADA by excluding adults with disabilities who 
were not mentally alert).
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Scope of Application and Application to Excepted Benefits and Short-
Term Limited Duration Insurance

    Proposed Sec.  92.207 applies to all the operations of covered 
entities that provide or administer health insurance coverage or other 
health-related coverage, including health programs and activities that 
receive Federal financial assistance, and the Department in the 
administration of its health-related coverage programs, but would not 
apply to employers generally or in their provision of employee health 
benefits per proposed Sec.  92.2(b). Examples of recipients that 
provide or administer health insurance coverage or other health-related 
coverage include health insurance issuers, Medicare Advantage 
organizations, Medicare Part D plan sponsors, and Medicaid managed care 
organizations.
    Per paragraph (b) of the proposed definition of ``health program or 
activity'' under proposed Sec.  92.4, we propose to apply this part to 
all the operations of any entity principally engaged in the provision 
or administration of health programs or activities described in 
paragraph (a) of the proposed definition of ``health program or 
activity,'' including a health insurance issuer. Thus, this proposed 
rule applies to all of a covered health insurance issuer's health 
programs and activities in the individual or group health insurance 
markets, including its offer of products through or outside of an 
Exchange. For example, an issuer participating in the Exchange and 
thereby receiving Federal financial assistance would be covered by the 
rule for its qualified health plans (QHPs) offered on the Exchange, as 
well as for its health plans offered outside the Exchange, including, 
for example, large group market plans,\486\ grandfathered plans,\487\ 
grandmothered plans,\488\ excepted benefits,\489\ and short-term 
limited duration insurance,\490\ as well as for its operations related 
to acting as a third party administrator for a self-insured group 
health plan.
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    \486\ 42 U.S.C. 300gg-91(2); 45 CFR 144.103.
    \487\ 42 U.S.C. 18011; 45 CFR 147.140.
    \488\ Grandmothered plans, also known as ``transitional'' plans, 
are certain non-grandfathered health insurance coverage in the 
individual and small group market that are not considered to be out 
of compliance with certain specified market reforms under certain 
conditions. See Ctrs. for Medicare & Medicaid Servs., Extended Non-
Enforcement of Affordable Care Act-Compliance With Respect to 
Certain Policies (Mar. 23, 2022), https://www.cms.gov/files/document/extension-limited-non-enforcement-policy-through-calendar-year-2023-and-later-benefit-years.pdf.
    \489\ 42 U.S.C. 300gg-91(c); 45 CFR 144.103, Sec.  146.145(b), 
Sec.  148.220. Excepted benefits are a tri-Department matter 
regulated by the Departments of HHS, Labor, and the Treasury. In 
this proposed rule, we cite to HHS regulations, but note that the 
Departments of Labor and the Treasury have parallel regulatory 
citations.
    \490\ Short-term limited duration insurance is a type of health 
insurance coverage that is not subject to most of the provisions of 
title XXVII of the Public Health Service Act because it is 
specifically excluded from the definition of individual health 
insurance coverage in the PHS Act. 42 U.S.C. 300gg-91(b)(5). Short-
term limited duration insurance is generally defined in Federal 
regulations as health insurance coverage issued under a contract 
that is effective for less than 12 months, and, taking into account 
renewals or extensions, has a duration of no longer than 36 months 
in total. 45 CFR 144.103. Short-term limited duration insurance is 
regulated by the Departments of HHS, Labor, and the Treasury. In 
this proposed rule, we cite to HHS regulations, but note that the 
Departments of Labor and the Treasury have parallel regulatory 
citations.
---------------------------------------------------------------------------

    We recognize that many of these health insurance products are not 
subject to the ACA's market reforms codified in title XXVII of the PHS 
Act \491\ in the same fashion as QHPs and other non-grandfathered 
health insurance coverage. For instance, large group market plans and 
grandfathered plans are subject to some but not all of the market 
reforms,\492\ whereas excepted benefits and short-term limited duration 
insurance are generally exempt from all of the ACA's market reforms. 
Excepted benefits are statutorily defined benefits that are exempt from 
certain health care requirements, such as the ACA's market

[[Page 47876]]

reforms \493\ and the nondiscrimination and portability requirements of 
HIPAA \494\ when certain conditions are met, such as when benefits are 
supplemental to other medical benefits, when benefits are limited in 
scope, or when the benefits are provided as independent, non-
coordinated benefits.\495\ Examples of excepted benefits include 
limited scope vision insurance and limited scope dental insurance 
(though stand-alone dental plans sold through the Exchange are subject 
to certain QHP requirements \496\), long term care insurance, specified 
disease insurance, and Medicare supplemental health insurance (also 
known as ``Medigap'').
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    \491\ 42 U.S.C. 300gg et seq.
    \492\ For example, large group market plans and grandfathered 
plans are not subject to the ACA's fair health insurance premiums 
(42 U.S.C. 300gg) or essential health benefits (42 U.S.C. 300gg-6) 
requirements.
    \493\ 42 U.S.C. 300gg-21(b)-(c), 300gg-63.
    \494\ Public Law 104-191, 100 Stat. 2548 (1996).
    \495\ 42 U.S.C. 300gg-91(c); 29 U.S.C. 1191b(c).
    \496\ See, e.g., 45 CFR 155.1065, Sec.  156.150.
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    Public comments received from health insurance entities on the 2015 
and 2019 NPRMs opposed application of Section 1557 nondiscrimination 
requirements to excepted benefits and short-term limited duration 
insurance.\497\ The 2020 Rule narrowed the scope of application to 
health insurance at Sec.  92.3(b)-(c) to provide that an issuer 
principally engaged in the business of providing health insurance shall 
not, by virtue of such provision, be covered by Section 1557 in all of 
its operations. This resulted in coverage of an issuer's operations 
only with respect to the particular line or sub-line of business for 
which the issuer receives Federal financial assistance, which 
effectively exempts coverage of excepted benefits and short-term 
limited duration insurance from the requirements established under the 
2020 Rule.\498\
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    \497\ See 81 FR 31375, 31430-31 (May 18, 2016); 85 FR 37160, 
37173 (June 19, 2020).
    \498\ See 85 FR 37173.
---------------------------------------------------------------------------

    Unlike the 2020 Rule, this proposed rule would apply to all of an 
issuer's health programs and activities when an issuer is principally 
engaged in providing or administering health insurance coverage, or 
other health-related coverage as specified under paragraph (b) in the 
proposed definition of ``health program or activity'' under proposed 
Sec.  92.4.\499\ The fact that excepted benefits and short-term limited 
duration insurance are exempt from the ACA's market reforms because 
they are not intended to serve as comprehensive medical insurance does 
not negate that offering such insurance is a ``health program or 
activity.'' Further, the text of Section 1557 does not limit its 
protections only to health programs and activities that are subject to 
other provisions of the ACA. However, because the Department believes 
commenters' concerns about the application of Section 1557 to excepted 
benefits and short-term limited duration insurance warranted further 
consideration, we have provided additional discussion on how OCR 
proposes to analyze allegations of discrimination in such products in 
the preceding discussion on benefit design.
---------------------------------------------------------------------------

    \499\ We note that some health insurance issuers may be 
considered principally engaged in the business of providing health 
care as defined under the 2020 Rule at Sec.  92.3(b), such as 
issuers offering HMO plans.
---------------------------------------------------------------------------

Application to Third Party Administrators

    An issuer's or other entity's operations related to third party 
administrative services also would be subject to the rule when the 
issuer receives Federal financial assistance and is deemed to be 
principally engaged in the provision or administration of health 
programs or activities as described in paragraph (a) of the proposed 
definition of ``health program or activity'' under proposed Sec.  92.4, 
which includes providing or administering health-related services, 
health insurance coverage, or other health-related coverage. We 
recognize that the Employee Retirement Income Security Act of 1974 
(ERISA) requires group health plans to be administered consistent with 
their terms,\500\ and, therefore, third party administrators are unable 
to change any discriminatory design features in the self-insured plans 
they administer to comply with Section 1557's requirements. In the 2016 
Rule, we clarified that third party administrators were generally not 
responsible for the benefit designs of the self-insured group health 
plans they administer and that enforcing Section 1557 against a third 
party administrator for a group health plan with a discriminatory 
benefit design could result in holding a third party administrator 
liable for plan designs over which it had no control. Some third party 
administrators, however, are responsible for the development of the 
group health plan document or other policy documents that are 
ultimately adopted by the self-insured plan. Under these circumstances, 
where the discriminatory terms of the group health plan originated with 
the third party administrator rather than with the plan sponsor, the 
third party administrator could be liable for the discriminatory design 
feature under Section 1557.\501\
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    \500\ ERISA Section 404(a)(1)(D) (29 U.S.C. 1104(a)(1)(D)).
    \501\ See Tovar v. Essentia Health, 342 F. Supp. 3d 947, 954 (D. 
Minn. 2018) (holding that a third party administrator may be liable 
under Section 1557 for damages arising from discriminatory terms in 
a self-insured, employer-sponsored health plan that was under the 
sole control of the employer by refusing to construe ERISA to impair 
Section 1557 and finding that ``[n]othing in Section 1557, 
explicitly or implicitly, suggests that [third party administrators] 
are exempt from the statute's nondiscrimination requirements'').
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    When OCR receives a complaint alleging discrimination in a self-
insured group health plan administered by a covered entity acting as a 
third party administrator, we propose to adopt an approach similar to 
the 2016 Rule that takes into account the party responsible for the 
alleged discriminatory conduct.\502\ We also restate the 2016 Rule's 
position that we will engage in a fact-specific analysis to evaluate 
whether a third party administrator is appropriately covered under 
Section 1557 as a recipient of Federal financial assistance in 
circumstances where the third party administrator is legally separate 
from the issuer that receives Federal financial assistance.
---------------------------------------------------------------------------

    \502\ See 81 FR 31432.
---------------------------------------------------------------------------

    We also newly address that a third party administrator may be 
liable under this part when it is responsible for the underlying 
discriminatory plan design feature that is adopted by a group health 
plan. This modification is consistent with subsequent case law holding 
the same.\503\ Accordingly, OCR will determine whether responsibility 
for the decision or alleged discriminatory action lies with the plan 
sponsor or with the third party administrator. Where the alleged 
discrimination relates to the administration of the plan by a covered 
third party administrator, OCR will process the complaint against the 
third party administrator because it is the entity responsible for the 
decision or other action being challenged in the complaint. For 
example, if a third party administrator denies a claim because the 
individual's name suggests that they are of a certain race or national 
origin, or threatens to expose an employee's transgender or disability 
status to the employee's employer, OCR will proceed against the third 
party administrator as the entity responsible for the decision. In 
addition, OCR will pursue claims

[[Page 47877]]

against the third party administrator in circumstances where the third 
party administrator is the entity responsible for developing the 
discriminatory benefit design feature that was adopted by the employer. 
On the other hand, where the alleged discrimination relates to the 
benefit design of a self-insured group health plan that did not 
originate with the third party administrator, but rather with the plan 
sponsor, OCR will refer the complaint to the EEOC or the DOJ for 
potential investigation.
---------------------------------------------------------------------------

    \503\ See Tovar, 342 F. Supp. at 954 (holding that a third party 
administrator may be liable under Section 1557 for damages arising 
from discriminatory terms in a self-insured, employer-sponsored 
health plan that was under the sole control of the employer by 
refusing to construe ERISA to impair Section 1557 and finding that 
``[n]othing in Section 1557, explicitly or implicitly, suggests that 
[third party administrators] are exempt from the statute's 
nondiscrimination requirements'').
---------------------------------------------------------------------------

    As part of OCR's enforcement authority, OCR has the option of 
referring or transferring matters to other Federal agencies with 
jurisdiction over the entity. For example, OCR will transfer matters to 
the EEOC where OCR lacks jurisdiction over an employer responsible for 
the benefit design of an employer-sponsored group health plan.\504\ 
Complaints alleging discrimination in the Federal Employees Health 
Benefits (FEHB) Program, the Federal Employees Dental and Vision 
Insurance Program (FEDVIP), or the Federal Long Term Care Insurance 
Program (FLTCIP), would be referred to OPM. This Rule does not 
determine how or whether any other agency will investigate or enforce 
any matter referred or transferred by the Department.
---------------------------------------------------------------------------

    \504\ See 28 CFR 42.605.
---------------------------------------------------------------------------

Network Adequacy

    Plan choices regarding provider networks may also violate Section 
1557. Network plans offer medical care through a defined set of 
providers under contract with the issuer.\505\ Subject to other 
applicable Federal and State laws, covered entities have discretion in 
developing their networks of providers, establishing reimbursement 
rates, and determining cost-sharing for in-network and out-of-network 
providers, including excluding coverage for out-of-network care. 
Covered entities using provider networks may be subject to certain 
network adequacy requirements governed by state and Federal law.\506\ 
For example, CMS regulations contain network adequacy requirements for 
QHPs \507\ (including essential community providers),\508\ Medicare 
Advantage plans,\509\ Medicare Part D prescription drug plans,\510\ and 
Medicaid managed care plans.\511\ Several of these regulations 
prescribe specific requirements, such as listing the types of providers 
that must be included in the network \512\ and establishing time and 
distance standards for providers within a certain area.\513\ QHPs that 
maintain a provider network must ensure that the provider network 
consisting of in-network providers includes essential community 
providers and is ``sufficient in number and types of providers, 
including providers that specialize in mental health and substance 
abuse services, to ensure that all services will be accessible without 
unreasonable delay.'' \514\ Starting in plan years 2023 and 2024 
respectively, QHP issuers on a Federally-facilitated Exchange must meet 
time and distance standards, and appointment wait time standards 
established by the Federally-facilitated Exchange.\515\
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    \505\ 42 U.S.C. 300gg-91(10); 45 CFR 144.103 (defining ``network 
plan'' as ``health insurance coverage of a health insurance issuer 
under which the financing and delivery of medical care (including 
items and services paid for as medical care) are provided, in whole 
or in part, through a defined set of providers under contract with 
the issuer'').
    \506\ Network adequacy refers to ``a health plan's ability to 
deliver the benefits promised by providing reasonable access to 
enough in-network primary care and specialty physicians, and all 
health care services included under the terms of the contract.'' 
Network Adequacy, Nat'l Ass'n of Ins. Comm'rs, https://content.naic.org/cipr_topics/topic_network_adequacy.htm (last 
updated Aug. 25, 2021).
    \507\ 45 CFR 156.230; see also Patient Protection and Affordable 
Care Act; HHS Notice of Benefit and Payment Parameters for 2023, 87 
FR 27208, 27322-34 (May 6, 2022) (discussing changes to network 
adequacy requirements for qualified health plans at 45 CFR 156.230); 
U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & Medicaid 
Servs., 2023 Letter to Issuers in the Federally-facilitated 
Exchanges, pp. 10-17 (April 28, 2022), https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Final-2023-Letter-to-Issuers.pdf.
    \508\ 45 CFR 156.235; see also 87 FR 27334-37 (discussing 
changes to the essential community providers requirements for 
qualified health plans at 45 CFR 156.235).
    \509\ See e.g., 42 CFR 422.116; U.S. Dep't of Health & Human 
Servs., Ctrs. for Medicare & Medicaid Servs., Medicare Advantage and 
Section 1876 Cost Plan Network Adequacy Guidance (2020), https://www.cms.gov/files/document/medicareadvantageandsection1876costplannetworkadequacyguidance6-17-2020.pdf.
    \510\ 42 CFR 423.120(a).
    \511\ 42 CFR 438.68 (requiring states to establish specified 
network adequacy requirements).
    \512\ 42 CFR 422.116(b) (Medicare Advantage); Sec.  438.68(b) 
(Medicaid).
    \513\ 42 CFR 422.116(d) (Medicare Advantage); Sec.  423.120 (a) 
(Part D); Sec.  438.68(c) (Medicaid).
    \514\ 45 CFR 156.230(a)(1)-(2).
    \515\ 87 FR 27322-34 (discussing changes to network adequacy 
requirements for qualified health plans at 45 CFR 156.230).
---------------------------------------------------------------------------

    Recognizing that network adequacy is regulated by other 
departmental regulations, we noted in the 2016 Rule, and again note 
here, that it is outside the scope of Section 1557 to establish uniform 
or minimum network adequacy standards. Nonetheless, the prevalence of 
narrow networks continues to grow as payers seek to keep premiums and 
costs low and drive patients to high-value providers.\516\ Provider 
networks that limit or deny access to care for individuals with certain 
disabilities, such as by excluding certain providers from the network 
that treat high-cost enrollees, raise discrimination concerns.\517\ 
Similarly, limited provider networks may require transgender enrollees 
to visit inexperienced providers in order to receive services, 
regardless of the potentially serious risks from receiving inadequate 
care. Enrollees are often required to prove why an in-network provider 
cannot meet their needs before their insurance will cover an out-of-
network provider, raising additional obstacles that may cause 
particular harm to individuals with disabilities, transgender people, 
or other groups.\518\
---------------------------------------------------------------------------

    \516\ Steven Findlay, In Search Of Insurance Savings, Consumers 
Can Get Unwittingly Wedged Into Narrow-Network Plans, Kaiser Health 
News (Nov. 1, 2018), https://khn.org/news/in-search-of-insurance-savings-consumers-can-get-unwittingly-wedged-into-narrow-network-plans/ (discussing 73% of plans offered through the Exchange in 2018 
had restrictive networks compared to 54% in 2015).
    \517\ See Valarie K. Blake, Restoring Civil Rights to the 
Disabled in Health Insurance, 95 Neb. L. Rev. 1071, 1086 (2016), 
https://digitalcommons.unl.edu/cgi/viewcontent.cgi?article=3046&context=nlr; see also, Mark Shepard, 
Nat'l Bureau of Econ. Research, Working Paper 22600: Hospital 
Network Competition & Adverse Selection: Evidence from the 
Massachusetts Health Insurance Exchange (2016), https://www.nber.org/papers/w22600 (finding high-cost enrollees favor plans 
that include expensive ``star'' hospitals in their network, which 
incentivizes plans not to include such hospitals in their networks); 
Subodh Potla et al., Access to Neurosurgery in the Era of Narrowing 
Insurance Networks: Statewide Analysis of Patient Protection and 
Affordable Care Act Marketplace Plans in Arizona, 149 World 
Neurosurgery e963 (May 2021), https://pubmed.ncbi.nlm.nih.gov/33515792/ (finding 67 percent of counties in Arizona do not have 
access to outpatient neurosurgical care despite the presence of 
neurosurgical facilities in most counties); Stephen M. Schleicher et 
al., Effects of Narrow Networks on Access to High-Quality Cancer 
Care, 2 JAMA Oncology 427 (2016), https://jamanetwork.com/journals/jamaoncology/article-abstract/2499779 (finding more than half of 
Exchange plans excluded four of eleven cancer centers).
    \518\ Health Insurance--Choosing a Plan, Transgender Legal 
Defense & Education Fund, Trans Health Project, https://transhealthproject.org/trans-health-insurance-tutorial/choosing-plan/ (last updated July 16, 2020).
---------------------------------------------------------------------------

    We understand that an array of factors can affect the provider 
network design of a plan, including the geographic location of the 
service area, the number of available providers and specialists in the 
service area, reimbursement rates, the number of providers willing to 
contract with the payer, and the overall design of the plan as it 
relates to premiums. We recognize plans' and issuers' autonomy in 
developing their provider networks as part of their benefit design 
packages, consistent with existing state and Federal network adequacy 
and other laws, and we do not

[[Page 47878]]

propose to prescribe specific network adequacy requirements for covered 
entities under this rule. However, to ensure compliance with Section 
1557, payers must develop their networks in a manner that does not 
discriminate against enrollees on the basis of race, color, national 
origin, sex, age, or disability.
    We generally seek comment on how Section 1557 might apply to: 
provider networks; how provider networks are developed, including 
factors that are considered in the creation of the network and steps 
taken to ensure that an adequate number of providers and facilities 
that treat a variety of health conditions are included in the network; 
the ways in which provider networks limit or deny access to care for 
individuals on the basis of race, color, national origin, sex, age, or 
disability; and the extent to which the lack of availability of 
accessible medical diagnostic equipment in a provider network limits or 
denies access to care for individuals with disabilities.
    In addition, the Department is also aware of growing concerns 
regarding impermissible discrimination in the application of value 
assessment methodologies used to set valuations for health care goods 
and services. Value assessment methodologies are an important tool to 
support health care payers in their coverage decisions and can 
significantly influence health benefit design, particularly through 
their use in price negotiations and value-based purchasing 
arrangements, as well as by informing utilization management decisions. 
However, where value assessment makes use of methods for calculating 
value that penalize individuals or groups of individuals on the basis 
of race, color, national origin, sex, age, or disability (e.g., by 
placing a lower value on life-extension for a group of individuals 
based on a protected basis or via inappropriate adjustment of clinical 
end points on the basis of a protected basis under Section 1557), they 
may violate this part. To that end, OCR seeks comment on the extent, 
scope and nature of value assessment methods that discriminate on the 
basis of race, color, national origin, sex, age, or disability. We are 
interested in feedback on the civil rights implications of value 
assessment across a wide variety of contexts, including utilization 
management, formulary design, price negotiations, alternative payment 
models and other relevant applications.
    Finally, we seek comment on all aspects of this section. In 
particular, we seek comment on the anticipated impact of the proposed 
application to excepted benefits and short-term limited duration 
insurance plans when such products are offered by a covered entity; how 
the proposed rule's nondiscrimination requirements would impact the 
industry that offers excepted benefits and short-term limited duration 
insurance and the consumers who rely upon those products; the 
prevalence of excepted benefits and short-term limited duration 
insurance offered by covered entities and the standard industry 
practices under which such plans are designed and administered; and 
excepted benefits and short-term limited duration insurance plans' 
scope of coverage, types of exclusions and limitations, underwriting 
practices, premium setting, and actuarial or business justifications 
for industry practices (as applicable), that may raise concerns about 
discrimination under Section 1557.

Prohibition on Sex Discrimination Related to Marital, Parental, or 
Family Status (Sec.  92.208)

    The Department proposes in Sec.  92.208 to provide that covered 
entities are prohibited from discriminating on the basis of sex in 
their health programs and activities with respect to an individual's 
marital, parental, or family status. The 2016 and 2020 Final Rules did 
not include a similar provision. This is not a new concept, however, as 
it is similar to the Department's Title IX regulation.\519\
---------------------------------------------------------------------------

    \519\ 45 CFR 86.40(a).
---------------------------------------------------------------------------

    The Department is proposing this provision to address issues OCR 
has encountered in its Section 1557 enforcement work. For example, OCR 
has resolved complaints against covered entities with policies of 
automatically assigning a male spouse as the guarantor when a female 
spouse received medical services, while not automatically assigning a 
female spouse as the guarantor when a male spouse received medical 
services.\520\
---------------------------------------------------------------------------

    \520\ Sex Case Summaries: Summary of Selected OCR Compliance 
Activities, Dep't of Health & Human Servs., Office for Civil Rights, 
https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/examples/sex-discrimination/index.html (last updated 
Feb. 21, 2017).
---------------------------------------------------------------------------

    Proposed Sec.  92.208 thus would provide that, in determining 
whether an individual satisfies any policy or criterion regarding 
access to its health programs or activities, a covered entity must not 
take an individual's sex into account in applying any rule concerning 
an individual's current, perceived, potential, or past marital, 
parental, or family status.
    The Department is also considering whether Sec.  92.208 should 
include a provision to specifically address discrimination on the basis 
of pregnancy-related conditions.\521\ Although neither the 2016 nor the 
2020 Rules included a stand-alone provision prohibiting discrimination 
on the basis of pregnancy-related conditions, the 2016 Rule defined 
discrimination ``on the basis of sex'' to include, inter alia, 
discrimination on the basis of ``pregnancy, false pregnancy, 
termination of pregnancy, or recovery therefrom, childbirth or related 
medical conditions.'' \522\ The 2020 Rule does not include a definition 
of ``on the basis of sex'' at all, and therefore does not specifically 
include in the Section 1557 regulation a prohibition on discrimination 
on the basis of a person's ``termination of pregnancy'' or other 
conditions related to pregnancy.
---------------------------------------------------------------------------

    \521\ Such a provision would supplement proposed 92.101(a)(2), 
in which the Department proposes to define ``on the basis of sex'' 
to include pregnancy discrimination. See discussion supra Sec.  
92.101(a)(2).
    \522\ Former 45 CFR 92.4. Although the Franciscan Alliance court 
vacated the inclusion of the term ``termination of pregnancy'' in 
the 2016 Rule's definition of discrimination on the basis of sex, 
that vacatur neither applies to this current rulemaking, nor to a 
possible new final provision prohibiting discrimination on the basis 
of pregnancy-related conditions.
---------------------------------------------------------------------------

    The 2020 Rule does, however, prohibit discrimination on any of the 
``grounds'' prohibited under Title IX,\523\ and the Department's Title 
IX regulation, in turn, includes a provision expressly prohibiting 
discrimination on the basis of pregnancy-related conditions, including 
childbirth, false pregnancy, termination of pregnancy, and recovery 
therefrom.\524\ Under this proposed rule, too, recipients would be 
required to comply with the specific prohibitions on discrimination 
found in the Department's Title IX regulations (including the 
regulation prohibiting discrimination on the basis of pregnancy-related 
conditions, including childbirth, false pregnancy, termination of 
pregnancy, and recovery therefrom).\525\ In that respect it would not 
deviate from the 2016 or the 2020 Rule.
---------------------------------------------------------------------------

    \523\ 45 CFR 92.2(a), (b)(2).
    \524\ 45 CFR 86.40(a).
    \525\ See proposed 45 CFR 92.101(b).
---------------------------------------------------------------------------

    At the same time the Department promulgated the 2020 Rule, the 
Department amended its Title IX regulations to expressly include Title 
IX's statutory abortion neutrality provision,\526\ and included in the 
Department's Section 1557 regulation a provision stating that the 
Section 1557 regulations may not be applied insofar as they would 
``depart from, or contradict,'' Title IX exemptions, rights,

[[Page 47879]]

or protections.\527\ This aspect of the 2020 Rule has been challenged 
in litigation.\528\ This NPRM proposes repealing 45 CFR 92.6(b), the 
provision of the 2020 Rule challenged in those cases. The Department's 
view is that Section 1557 does not require the Department to 
incorporate the language of Title IX's abortion neutrality provision 
\529\ into its Section 1557 regulation. This approach is consistent 
with the 2016 rule, which also did not incorporate Title IX's abortion 
neutrality provision. We acknowledge that the Franciscan Alliance court 
vacated the challenged provisions of the 2016 rule and reasoned that 
the Department was required to incorporate the language of Title IX's 
abortion neutrality provision; however, we disagree with that decision, 
which does not bind this new rulemaking.
---------------------------------------------------------------------------

    \526\ See 85 FR 37243 (promulgating 45 CFR 86.18(b)).
    \527\ See 45 CFR 92.6(b)).
    \528\ See BAGLY v. U.S. Dep't of Health & Human Servs., No. 
1:20-cv-11297 (D. Mass. Sept. 18, 2020); New York v. U.S. Dep't of 
Health & Human Servs., No. 1:2-cv-00583 (S.D.N.Y. July 20, 2020). 
This NPRM proposes repealing 45 CFR 92.6(b), the provision of the 
2020 Rule challenged in those cases.
    \529\ 20 U.S.C. 1688 (``Nothing in this chapter 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 this section 
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.'').
---------------------------------------------------------------------------

    The Department does note, however, that there are several other 
statutory and regulatory provisions related to the provision of 
abortions that may apply to an entity covered by Section 1557, and OCR 
will apply such provisions consistent with the law. For example, the 
Weldon Amendment forbids funds appropriated to HHS, among other 
Departments, from being ``made available to a Federal agency or 
program, or to a state or local government, if such agency, program, or 
government subjects any institutional or individual health care entity 
to discrimination on the basis that the health care entity does not 
provide, pay for, provide coverage of, or refer for abortions.'' \530\ 
The Coats-Snowe Amendment forbids discriminating against an entity that 
refuses to undergo training in performance or referrals for 
abortions.\531\ The Church Amendment forbids requiring any individual 
``to perform or assist in the performance of any part of a health 
service program . . . if his performance or assistance in the 
performance of such part of such program . . . would be contrary to his 
religious beliefs or moral convictions.'' \532\ It also provides that 
an entity's receipt of any grant, contract, loan, or loan guarantee 
under the Public Health Service Act, the Community Mental Health 
Centers Act, or the Developmental Disabilities Services and Facilities 
Construction Act ``does not authorize any court or any public official 
or other public authority to require . . . such entity to . . . make 
its facilities available for the performance of any sterilization 
procedure or abortion if the performance of such procedure or abortion 
in such facilities is prohibited by the entity on the basis of 
religious beliefs or moral convictions.'' \533\ The Church Amendment 
also prohibits discrimination against health care personnel related to 
their employment or staff privileges because they ``performed or 
assisted in the performance of a lawful sterilization procedure or 
abortion.'' \534\ The same nondiscrimination protections also apply to 
health care personnel who refuse to perform or assist in the 
performance of sterilization procedures or abortion.\535\ In addition, 
some of HHS' programs and services are specifically governed by 
abortion restrictions in the underlying statutory authority or program 
authorization.\536\
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    \530\ Consolidated Appropriations Act, 2022, Public Law 117-103, 
div. H, title V General Provisions, sec. 507(d)(1) (Mar. 15, 2022). 
See also, e.g., the ``Hyde Amendment,'' Consolidated Appropriations 
Act, 2021, Public Law 116-260, div. H, Sec. Sec.  506-07, 134 Stat. 
1182 (Dec. 27, 2020).
    \531\ 42 U.S.C. 238n(a).
    \532\ 42 U.S.C. 300a-7(d).
    \533\ Id. 300a-7(b)(2)(A).
    \534\ Id. 300a-7(c)(1). For more information, see Guidance on 
Nondiscrimination Protections under the Church Amendments, U.S. 
Dep't of Health & Hum. Servs., https://www.hhs.gov/conscience/conscience-protections/guidance-church-amendments-protections/index.html (last updated Sept. 17, 2021).
    \535\ Id.
    \536\ See, e.g., Title X of the PHS Act, 24 U.S.C. 300a-6; 
Section 1303(b)(4) of the ACA, 42 U.S.C. 18023.
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    The Department also notes in this regard that the Emergency Medical 
Treatment and Active Labor (EMTALA) provides rights to individuals when 
they seek examination or treatment and appear at an emergency 
department of a hospital that participates in Medicare.\537\ If that 
person has an ``emergency medical condition,'' the hospital must 
provide available stabilizing treatment, including abortion, or an 
appropriate transfer to another hospital that has the capabilities to 
provide available stabilizing treatment, notwithstanding any directly 
conflicting state laws or mandate that might otherwise prohibit or 
prevent such treatment.
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    \537\ 42 U.S.C. 1395dd. For more information, see Letter to 
State Survey Agency Directors from U.S. Dep't of Health & Human 
Servs., Ctrs. for Medicare & Medicaid Servs., Directors, Quality, 
Safety & Oversight Group and Survey & Operations Group (July 11, 
2022), https://www.cms.gov/files/document/qso-22-22-hospitals.pdf.
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    The Department believes it could be beneficial to include a 
provision specifically prohibiting discrimination on the basis of 
pregnancy-related conditions as a form of sex-based discrimination. We 
seek comment on whether and how the Department should do so. We also 
seek comment on what impact, if any, the Supreme Court decision in 
Dobbs v. Jackson Women's Health Organization \538\ has on the 
implementation of Section 1557 and these regulations. In light of the 
Dobbs decision and E.O. 14076,\539\ the Department also seeks comments 
on other approaches to ensure nondiscriminatory access to care under 
this provision.
---------------------------------------------------------------------------

    \538\ 142 S. Ct. 2228 (2022).
    \539\ 87 FR 42053 (July 8, 2022).
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    Though Congress did not require the Department to incorporate the 
language of Title IX abortion-neutrality provision in its Section 1557 
regulations, we seek comment on this approach and on other possible 
readings of the Title IX abortion-neutrality provision, as well as 
whether the Department should align its Title IX regulation regarding 
the abortion neutrality provision of Title IX with the 2000 ``Common 
Rule'' version of that regulatory provision that more than 20 agencies 
have long adopted.\540\
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    \540\ See 65 FR 52869 (Aug. 30, 2000); see also, e.g., 28 CFR 
54.235(d)(1) (DOJ regulation). The agencies that have adopted the 
Common Rule include: Agency for International Development, 22 CFR 
pt. 229; Corporation for National and Community Service, 45 CFR pt. 
2555; Department of Agriculture, 7 CFR pt. 15d.; Department of 
Commerce, 15 CFR pt. 8a; Department of Defense, 32 CFR pt. 196; 
Department of Energy, 10 CFR 1040; Department of Homeland Security, 
6 CFR pt. 17; Department of Housing and Urban Development, 24 CFR 
pt. 3; Department of the Interior, 43 CFR pt. 41; Department of 
Justice, 28 CFR pt. 54; Department of Labor, 29 CFR pt. 36; 
Department of State, 22 CFR pt. 146; Department of Transportation, 
49 CFR pt. 25; Department of the Treasury, 31 CFR pt. 28; Department 
of Veterans Affairs, 38 CFR pt. 23; Environmental Protection Agency, 
40 CFR pt. 5; Federal Emergency Management Agency, 44 CFR pt. 19; 
General Services Administration, 41 CFR pt. 101-4; National 
Aeronautics and Space Administration, 14 CFR pt. 1253; National 
Archives and Records Administration, 36 CFR pt. 1211; National 
Science Foundation, 45 CFR pt. 618; Nuclear Regulatory Commission, 
10 CFR pt. 5; Small Business Administration, 13 CFR pt. 113; and 
Tennessee Valley Authority, 18 CFR pt. 1317.
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Nondiscrimination on the Basis of Association (Sec.  92.209)

    Proposed Sec.  92.209 prohibits discrimination against an 
individual on the basis of the race, color, national origin, sex, age, 
or disability of an individual with whom the individual is

[[Page 47880]]

known to have a relationship or association. Longstanding 
interpretations of existing civil rights laws recognize claims of 
associational discrimination, where the basis is a characteristic of 
the harmed individual or an individual who is associated with the 
harmed individual.\541\ In addition, the proposed prohibition on 
associational discrimination under Section 1557 corresponds with the 
specific prohibition of discrimination based on association with an 
individual with a disability under Section 504.\542\
---------------------------------------------------------------------------

    \541\ See Kengerski v. Harper, No. 20-1307, 2021 WL 3199225 (3d 
Cir. 2021) (a white plaintiff employee's claim is justiciable under 
an associational discrimination legal theory under Title VII of the 
Civil Rights Act of 1964, where his employer retaliated against him 
for complaining about a supervisor's racist remarks directed at the 
employee's biracial family member and other minority coworkers); 
Kelleher v. Fred A. Cook, Inc., 939 F.3d 465 (2d Cir. 2019) (an 
employer's reaction to a non-disabled employee's reasonable 
accommodation request to care for disabled dependent can support an 
inference of associational discrimination); McGinest v. GTE Serv. 
Corp., 360 F.3d 1103, 1118 (9th Cir. 2004) (case involving indirect 
comments in the workplace that crossed racial lines, noting that 
``Title VII has . . . been held to protect against adverse 
employment actions taken because of the employee's close association 
with black friends or coworkers'') (internal citations omitted); 
Johnson v. Univ. of Cincinnati, 215 F.3d 561, 574 (6th Cir. 2001) (a 
plaintiff who is not a member of a recognized protected class 
nevertheless alleges a cognizable discrimination claim under Title 
VII and 42 U.S.C. 1981 if he alleges that he was discriminated 
against based on his association with a member of a recognized 
protected class); Tetro v. Elliot Popham Pontiac, Oldsmobile, Buick 
& GMC Trucks Inc., 173 F.3d 988, 994-95 (6th Cir. 1999) (holding 
that white plaintiff with biracial child stated a claim under Title 
VII based on his own race ``even though the root animus for the 
discrimination is a prejudice against the biracial child''); Parr v. 
Woodmen of the World Life Ins., 791 F.2d 888, 892 (11th Cir. 1986) 
(``Where a plaintiff claims discrimination based upon an interracial 
marriage or association, he alleges by definition that he has been 
discriminated against because of his race.''); Arceneaux v. 
Vanderbilt Univ., 25 Fed. App'x. 345 (6th Cir. 2001) (unpub'd) 
(treating sex discrimination as associational discrimination). Cf. 
Loving v. Va., 388 U.S. 1 (1967).
    \542\ 29 U.S.C. 794a(a)(2); see also McCullum v. Orlando Reg'l 
Healthcare Sys., Inc., 768 F.3d 1135, 1142 (11th Cir. 2014) (``[i]t 
is widely accepted that under both the [Rehabilitation Act] and the 
ADA, non-disabled individuals have standing to bring claims when 
they are injured because of their association with a disabled 
person.''); Loeffler v. Staten Island Univ. Hosp., 582 F.3d 268, 279 
(2d Cir. 2009) (permitting associational discrimination claim under 
Section 504). See also, 42 U.S.C. 12182(b)(1)(E) (ADA); Falls v. 
Prince George's Hosp. Ctr., No. 97-1545, 1999 WL 33485550 (D. Md. 
Mar. 16, 1999) (holding that parent had an associational 
discrimination claim under Title III of the ADA because hospital 
directly discriminated against parent by requiring hearing parent to 
act as interpreter for child who was deaf). See generally U.S. Equal 
Emp't Opportunity Comm'n, Association Q&A, supra note 396.
---------------------------------------------------------------------------

    The proposed provision is consistent with the former Sec.  92.209 
in the 2016 Rule, which was repealed by the 2020 Rule. OCR received 
many comments in response to the 2015 and 2019 NPRMs favoring the 
inclusion of an explicit provision in Section 1557 prohibiting 
discrimination on the basis of association.\543\ Of particular note, 
the preamble to the 2020 Rule acknowledged that commenters opposed the 
repeal of former Sec.  92.209 because: removing such protections would 
cause confusion; the lack of reference to associational discrimination 
in the regulatory text is inconsistent with existing case law; and 
specific protected populations are more susceptible to associational 
discrimination.\544\
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    \543\ See 81 FR 31375, 31438-39 (May 18, 2016); 85 FR 37160, 
37199 (June 19, 2020).
    \544\ 85 FR 37199.
---------------------------------------------------------------------------

    The Department agrees that additional clarity is beneficial in this 
area, as OCR continues to see complaints alleging discrimination based 
on association. For example, under this provision, a medical practice 
may not refuse to see a prospective female patient based, in part, on 
the knowledge that the patient has a female spouse or partner because 
the refusal would be based on the sex of the prospective patient and on 
the sex of an individual with whom the patient is known to have a 
relationship or association.

Use of Clinical Algorithms in Decision-Making (Sec.  92.210)

    Proposed Sec.  92.210 states that a covered entity must not 
discriminate against any individual on the basis of race, color, 
national origin, sex, age, or disability through the use of clinical 
algorithms in its decision-making. This is a new provision, and this 
topic has not been addressed in previous Section 1557 rulemaking. The 
Department believes it is critical to address this issue explicitly in 
this rulemaking given recent research demonstrating the prevalence of 
clinical algorithms that may result in discrimination.\545\ Further, 
the Department became aware that clinical algorithms in state Crisis 
Standards of Care plans used during the COVID-19 pandemic may be 
screening out individuals with disabilities, as discussed in more 
detail below. OCR believes that proposed Sec.  92.210 would put covered 
entities on notice that they cannot use discriminatory clinical 
algorithms and may need to make reasonable modifications in their use 
of the algorithms, unless doing so would cause a fundamental alteration 
to their health program or activity. The intent of proposed Sec.  
92.210 is not to prohibit or hinder the use of clinical algorithms but 
rather to make clear that discrimination that occurs through their use 
is prohibited.
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    \545\ See infra note 547.
---------------------------------------------------------------------------

    While covered entities are not liable for clinical algorithms that 
they did not develop, they may be held liable under this provision for 
their decisions made in reliance on clinical algorithms. Covered 
entities using clinical algorithms in their decision-making should 
consider clinical algorithms as a tool that supplements their decision-
making, rather than as a replacement of their clinical judgment. By 
over-relying on a clinical algorithm in their decision-making, such as 
by replacing or substituting their own clinical judgment with a 
clinical algorithm, a covered entity may risk violating Section 1557 if 
their decision rests upon or results in discrimination.
    Clinical algorithms are tools used to guide health care decision-
making and can range in form from flowcharts and clinical guidelines to 
complex computer algorithms, decision support interventions, and 
models. End-users, such as hospitals, providers, and payers (e.g., 
health insurance issuers) use these systems to assist with decision-
making for various purposes. Clinical algorithms are used for 
screening, risk prediction, diagnosis, prognosis, clinical decision-
making, treatment planning, health care operations, and allocation of 
resources,\546\ all of which affect the care that individuals receive. 
Recent studies have found that health care tools using clinical 
algorithms may create or contribute to discrimination on the bases 
protected by Section 1557, and as a result of their use by covered 
entities in their health care decision-making may lead to poorer health 
outcomes among members of historically marginalized communities.\547\
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    \546\ U.S. Dep't of Health & Human Servs., Agency for Healthcare 
Research & Quality, Impact of Healthcare Algorithms on Racial 
Disparities in Health and Healthcare (Jan. 25, 2022), https://effectivehealthcare.ahrq.gov/products/racial-disparities-health-healthcare/protocol; see also Sahar Takshi, Unexpected Inequality: 
Disparate-Impact from Artificial Intelligence in Healthcare 
Decisions, 34 J. L. & Health 215, 219 (2021), https://engagedscholarship.csuohio.edu/cgi/viewcontent.cgi?article=1580&context=jlh; Christina Badaracco, 
Avalere, AI in Healthcare: 5 Areas in Which Artificial Intelligence 
Is Disrupting the Status Quo (Dec. 16, 2019), https://avalere.com/insights/ai-in-healthcare-5-areas-in-which-artificial-intelligence-is-disrupting-the-status-quo (including preventive health and risk 
assessment; diagnosis, precision medicine, drug development, and 
administration and care delivery).
    \547\ See, e.g., Darshali A. Vyas et al., Hidden in Plain 
Sight--Reconsidering the Use of Race Correction in Clinical 
Algorithms, 383 N. Engl. J. Med. 874, 876-78 (Aug. 27, 2020); Ziad 
Obermeyer et al., Dissecting Racial Bias in an Algorithm Used to 
Manage the Health of Populations, 366 Science 447 (Oct. 2019), 
https://doi.org/10.4018/978-1-7998-7888-9.ch001; Donna M. 
Christensen et al., Medical Algorithms Are Failing Communities of 
Color, Health Affairs Blog (Sept. 9, 2021), https://www.healthaffairs.org/do/10.1377/hblog20210903.976632/full/; 
Kristine Gloria, Aspen Digital, Center for Inclusive Growth, Power 
and Progress in Algorithmic Bias (2021), https://www.aspeninstitute.org/wp-content/uploads/2021/07/Power-Progress-in-Algorithmic-Bias-July-2021.pdf.

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[[Page 47881]]

    Clinical algorithms commonly include clinical and sociodemographic 
variables and measures of health care utilization.\548\ Race and 
ethnicity are often used as explicit input variables. Known as ``race 
correction'' or ``race norming,'' this practice adjusts an algorithm's 
output on the basis of a patient's race or ethnicity.\549\ The use of 
``race norming'' notably garnered public attention when the National 
Football League (NFL) pledged to end the practice of adjusting the 
results of cognitive functioning tests based on race to determine 
settlement amounts for brain injury claims of former NFL players.\550\
---------------------------------------------------------------------------

    \548\ U.S. Dep't of Health & Human Servs., Agency for Healthcare 
Research & Quality, Healthcare Algorithms, supra note 546.
    \549\ Vyas, supra note 547, at 876-78 (2020).
    \550\ Will Hobson, How ``Race-Norming'' Was Built into the NFL 
Concussion Settlement, Wash. Post (Aug. 2, 2021), https://www.washingtonpost.com/sports/2021/08/02/race-norming-nfl-concussion-settlement/ (explaining race adjustments in cognitive 
test scores emanate from studies in the 1990s finding that some 
people of color, including Black people, performed worse than white 
people on cognitive tests).
---------------------------------------------------------------------------

    Another example of this practice can be found in the clinical tools 
that evaluate kidney function. Many such tools employ an estimation of 
glomerular filtration rate (eGFR) that includes race as a factor to 
reflect that Black people have been associated with higher levels of 
blood creatinine than white people.\551\ The option for entering race 
in the eGFR is limited to a binary ``black/non-black'' option. The eGFR 
adjusts the score for Black patients, making their kidneys register as 
16 percent healthier than white patients' kidneys even though Black 
Americans are about four times as likely to have kidney failure as 
white Americans and make up more than 35 percent of people on dialysis 
while representing only 13 percent of the U.S. population.\552\ This 
race-based practice reduces the number of Black people placed on 
transplant lists and referred for kidney disease management, nephrology 
specialists, and dialysis planning.\553\
---------------------------------------------------------------------------

    \551\ See Lundy Braun et al, Racialized Algorithms for Kidney 
Function: Erasing Social Experience, 286 J. Soc. Science & Med. 
113548, p. 5 (2021), https://doi.org/10.1016/j.socscimed.2020.113548 
(discussing how race correction in eGFR is rooted in the assumption 
that Black individuals as a group are biologically distinct and have 
higher muscle mass than other groups, which was based on studies 
from the 1970s, without considering ``the complexity of national 
origin, socioeconomic status, the bodily effects of racism, and 
other unexplored considerations that influence kidney function'').
    \552\ See, e.g., Nwamaka D. Eneanya et al., Race-Free Biomarkers 
to Quantify Kidney Function: Health Equity Lessons Learned From 
Population Based Research, 77 Am. J. of Kidney Diseases 667 (2021), 
https://doi.org/10.1053/j.ajkd.2020.12.001; Lesley A. Inker et al., 
A New Panel-Estimated GFR, Including [beta]2-Microglobulin and 
[beta]-Trace Protein and Not Including Race, Developed in a Diverse 
Population, 77 Am. J. of Kidney Diseases 673 (2021), https://doi.org/10.1053/j.ajkd.2020.11.005; Salman Ahmed et al., Examining 
the Potential Impact of Race Multiplier Utilization in Estimated 
Glomerular Filtration Rate Calculation on African-American Care 
Outcomes, 36 J. of Gen. Internal Med. 464, 466-67 (2021), https://link.springer.com/content/pdf/10.1007/s11606-020-06280-5.pdf.
    \553\ See Ahmed, supra note 552, at 467.
---------------------------------------------------------------------------

    Reliance on the eGFR clinical algorithm may lead to discrimination 
against patients based on race and ethnicity. For example, 
discrimination concerns arise if a covered entity takes action based on 
the algorithmic output that results in less favorable treatment of a 
Black patient as compared to white patients with similar or healthier 
kidneys because an algorithm determined that a Black patient's kidney 
function is better than it actually is.\554\ Concerns with the use of 
race in the estimation of GFR in the United States led the National 
Kidney Foundation and the American Society of Nephrology to create a 
task force on the issue, which ultimately recommended an approach that 
does not use race.\555\
---------------------------------------------------------------------------

    \554\ See, e.g., Compl., Crowley v. Strong Mem. Hosp. of the 
Univ. of Rochester, Civ. No. 21-cv-1078 (W.D.N.Y. Oct. 1, 2021) (22-
year-old biracial individual with kidney disease brought a Title VI 
and Section 1557 action against hospital for using a medical 
algorithm (eGRF) to assess kidney health that added a race-specific 
multiplier for a Black person, which deemed him ineligible for a 
kidney transplant).
    \555\ See Cynthia Delgado et al., A Unifying Approach for GFR 
Estimation: Recommendations of the NKF-ASN Task Force on Reassessing 
the Inclusion of Race in Diagnosing Kidney Disease, 79 Am. J. of 
Kidney Diseases 268, 283-284 (2022), https://doi.org/10.1053/j.ajkd.2021.08.003 (recommending a new estimating equation for GFR 
that does not incorporate race).
---------------------------------------------------------------------------

    The practice of ``race norming'' is not limited to eGFR, and also 
occurs in the following clinical tools: cardiology (to assess the risk 
of heart failure), cardiac surgery (to assess the risk of complications 
and death), obstetrics (to determine risks associated with vaginal 
birth after cesarean), urology (to assess the risk of kidney stones and 
urinary tract infections), oncology (to predict rectal cancer survival 
and breast cancer risk), endocrinology (to assess osteoporosis and 
fracture risks), and pulmonology (to measure lung function).\556\ 
Covered entities must be mindful when using tools that rely on racial 
or ethnic variables to ensure their reliance on such tools does not 
result in discriminatory clinical decisions. We encourage covered 
entities to use updated tools that have removed or do not have known 
biases, such as the updated eGFR discussed above.
---------------------------------------------------------------------------

    \556\ Vyas, supra note 547.
---------------------------------------------------------------------------

    The Department notes that the use of algorithms that rely upon race 
and ethnicity-conscious variables may be appropriate and justified 
under certain circumstances, such as when used as a means to identify, 
evaluate, and address health disparities.\557\ The Department also 
notes that the use of clinical algorithms may result in discriminatory 
outcomes when variables are used as a proxy for a protected basis and 
may also result from correlations between a variable and a protected 
basis.\558\
---------------------------------------------------------------------------

    \557\ See e.g., Michelle Tong & Samantha Artiga, Kaiser Family 
Foundation, Issue Brief: Use of Race in Clinical Diagnosis and 
Decision Making: Overview and Implications (Dec. 9, 2021), https://www.kff.org/racial-equity-and-health-policy/issue-brief/use-of-race-in-clinical-diagnosis-and-decision-making-overview-and-implications/
.
    \558\ See, e.g., Obermeyer, supra note 547.
---------------------------------------------------------------------------

    The use of clinical algorithms may also result in discrimination 
against individuals with disabilities and older adults. This issue 
surfaced in connection with Crisis Standards of Care and their use 
during the COVID-19 pandemic.\559\ During the COVID-19 public health 
emergency, OCR received complaints and requests for technical 
assistance related to state Crisis Standards of Care plans. OCR worked 
with multiple states to address nondiscrimination in their Crisis 
Standards of Care plans and practices, including the states of Alabama, 
Arizona, North Carolina, Texas, Tennessee, and Utah.\560\ Crisis 
Standards of Care are formal guidelines or policies adopted during an 
emergency or crisis that effect substantial change in usual health care 
operations and the level of care it is possible to deliver, which is 
made necessary by a pervasive or catastrophic disaster. In the 
effective marshaling of scarce resources, these standards may authorize 
the prioritization of scarce resources through means not permitted 
during non-crisis conditions. Crisis Standards of Care may include 
clinical algorithms in the form of flowcharts or other assessment tools 
intended to assist covered entities in prioritizing patients for scarce 
resources.
---------------------------------------------------------------------------

    \559\ See U.S. Dep't of Health & Human Servs., Office for Civil 
Rights FAQs for Healthcare Providers during the COVID-19 Public 
Health Emergency: Federal Civil Rights Protections for Individuals 
with Disabilities under Section 504 and Section 1557, Q4 (Feb. 4, 
2022), https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html.
    \560\ See Civil Rights and COVID-19, supra note 184.

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[[Page 47882]]

    Use of such assessment tools for making resource allocation 
decisions that screen out or tend to screen out individuals with 
disabilities from fully and equally enjoying any health care service, 
program, or activity being offered, would violate Section 1557, unless 
the criteria used in such tools can be shown to be necessary for the 
provision of the service, program or activity being offered.\561\ For 
example, to the extent an assessment tool considers a person's current 
health status, including a disability, for the purpose of determining a 
person's risk of in-hospital mortality as part of its resource 
allocation decision-making, such assessment tool might not violate this 
part, as consideration of short-term mortality risk is necessary for 
the implementation of Crisis Standards of Care. Similarly, assessment 
tools should not penalize patients for diminished long-term life-
expectancy.\562\ Assessment tools should not include categorical 
exclusions of certain types of disabilities, such as Down syndrome, 
when treatment would not be futile for individuals with that type of 
disability. As another example, Crisis Standards of Care may rely on 
instruments such as the Sequential Organ Failure Assessment (SOFA). The 
SOFA score is a scoring tool that assesses the performance of several 
organ systems in the body (neurologic, blood, liver, kidney, and blood 
pressure/hemodynamics) and assigns a score based on the data obtained 
in each category.\563\ The higher the SOFA score, the higher the likely 
mortality, and consequently the higher likelihood of de-prioritization 
of the patient under many Crisis Standards of Care allocation 
frameworks. In addition, the SOFA score includes algorithmic scoring 
systems, such as the Glasgow Coma Scale, to assess the likelihood of 
mortality. The Glasgow Coma Scale considers whether a person's speech 
is comprehensible and whether they obey commands for movement. Someone 
with cerebral palsy may have difficulty speaking or moving as part of 
their underlying disability, which does not contribute to the short-
term mortality outcomes the instrument is designed to assess. 
Adjustments must be made to ensure that such a person's pre-existing 
condition, and the symptoms of that condition, are not considered when 
using the Glasgow Coma Scale (whether within or outside of the SOFA) to 
evaluate whether they qualify for treatment or what priority they will 
receive in accessing scarce resources.\564\ When using such tools, an 
entity may need to make reasonable modifications as required by 
proposed Sec.  92.205 to its use of the assessment tool in order to 
avoid discrimination, unless doing so would cause a fundamental 
alteration.
---------------------------------------------------------------------------

    \561\ See also 42 U.S.C. 12182(b)(2)(A)(i) (ADA).
    \562\ See U.S. Dep't of Health & Human Servs., Office for Civil 
Rights, supra note 559, at Q4.
    \563\ See generally U.S. Dep't of Health & Human Servs., Office 
of the Assistant Sec'y for Preparedness & Response, Tech. Res. 
Assistance Ctr. & Info. Exchange (TRACIE), SOFA Score: What it is 
and How to Use it in Triage (Dec. 21, 2020), https://files.asprtracie.hhs.gov/documents/aspr-tracie-sofa-score-fact-sheet.pdf.
    \564\ See U.S. Dep't of Health & Human Servs., Office for Civil 
Rights, supra note 559, at Q4. See also Civil Rights and COVID-19, 
supra note 184.
---------------------------------------------------------------------------

    In addition, the Department notes the existence of an emerging body 
of research showing that the SOFA and other prognostic scoring 
algorithms used in Crisis Standards of Care frequently overestimate 
Black mortality, resulting in greater de-prioritization of Black 
patients under Crisis Standards of Care.\565\ The Department solicits 
comments on potential remedies to this issue and the larger topic of 
racial inequities in Crisis Standards of Care.
---------------------------------------------------------------------------

    \565\ See, e.g., Deepshikha C. Ashana et al., Equitably 
Allocating Resources During Crises: Racial Differences in Mortality 
Prediction Models, 204 a.m. J. Respir. Crit. Care Med. 178 (2021), 
https://pubmed.ncbi.nlm.nih.gov/33751910/ (finding use of SOFA in 
Crisis Standards of Care may lead to racial disparities in resource 
allocation); Benjamin Tolchin et al., Racial Disparities in the SOFA 
Score Among Patients Hospitalized with COVID-19, 16 PLoS ONE, Sept. 
2021, at p. 2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8448580/ 
(finding non-Hispanic Black patients but not Hispanic patients had 
greater odds of an elevated SOFA score when compared to non-Hispanic 
white patients); Shireen Roy et al., The Potential Impact of Triage 
Protocols on Racial Disparities in Clinical Outcomes Among COVID-
Positive Patients in a Large Academic Healthcare System, 16 PLoS 
ONE, Sept. 2021, at p. 2, https://pubmed.ncbi.nlm.nih.gov/34529684/ 
(finding Black patients had higher SOFA scores compared to patients 
of other races).
---------------------------------------------------------------------------

    Research suggests that overly relying upon any clinical algorithm, 
particularly without understanding the effects of its uses, may amplify 
and perpetuate racial and other biases.\566\ Accordingly, the 
Department strongly cautions covered entities against overly relying 
upon a clinical algorithm, for example, by replacing or substituting 
the individual clinical judgment of providers with clinical 
algorithms.\567\ The individual clinical judgment of a provider should 
always be based on the specific needs and medical history of the 
patient being treated.\568\ Covered entities that use clinical 
algorithms should consider using clinical algorithms as a tool to 
augment their decision-making but not as a replacement of clinical 
judgment. Covered entities that overly rely upon clinical algorithms 
run the risk of noncompliance with Section 1557 because such 
overreliance may result in discrimination.\569\
---------------------------------------------------------------------------

    \566\ See, e.g., Letter from the Am. Med. Ass'n to David Meyers, 
Agency for Healthcare Research & Quality, p. 6 (May 3, 2021), 
https://searchlf.ama-assn.org/letter/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2021-5-3-Letter-to-Meyers-re-AHRQ-AI-RFI-(002).pdf (in response to 
AHRQ's March 5, 2021 Request for Information on Use of Clinical 
Algorithms That Have the Potential to Introduce Racial/Ethnic Bias 
Into Healthcare Delivery) (stating that ``it is vital that all 
providers understand how the clinical algorithms they rely on to 
provide appropriate and equitable care in practice are developed. 
The need for such understanding is particularly acute as to how 
algorithms developed using artificial intelligence are trained in 
order to understand the appropriate uses for and limitations of such 
algorithms. Having this understanding will help ensure appropriate 
utilization of algorithms and encourage effective oversight by 
regulators, providers, and others. Over-reliance on any algorithm, 
particularly without an understanding of what its most effective 
uses are, can create a risk for amplifying and perpetuating biases 
that are present in the data, including any bias based in race or 
ethnicity.'').
    \567\ See, e.g., Public Comment from the Am. Acad. of Family 
Physicians to the Office of Mgmt. & Budget, pp. 4-5 (June 23, 2021), 
https://www.aafp.org/dam/AAFP/documents/advocacy/prevention/equality/LT-OMB-EquityRFI-062321.pdf (in response to OMB's May 5, 
2021 notice on Methods and Leading Practices for Advancing Equity 
and Support for Underserved Communities Through Government) (stating 
that ``AI-based technology is meant to augment decisions made by the 
user, not replace their clinical judgement or shared decision 
making.''); Elliot Crigger & Christopher Khoury, Making Policy on 
Augmented Intelligence in Health Care, 21 a.m. Med. Ass'n, J. of 
Ethics 2, E188-191, Feb. 2019, at pp. 188-189, https://journalofethics.ama-assn.org/article/making-policy-augmented-intelligence-health-care/2019-02 (discussing that health care AI 
should be a ``tool to augment professional clinical judgment, not a 
technology to replace or override it,'' and that organizations that 
implement AI systems ``should vigilantly monitor [the systems] to 
identify and address adverse consequences''); see also Nat'l Ass'n 
of Ins. Comm'rs, Principles on Artificial Intelligence (AI), p. 2 
(2020), https://content.naic.org/sites/default/files/inline-files/AI%20principles%20as%20Adopted%20by%20the%20TF_0807.pdf (discussing 
that AI actors ``should implement mechanisms and safeguards . . . to 
ensure all applicable laws and regulations are followed, including 
ongoing (human or otherwise) monitoring, and when appropriate, human 
intervention'').
    \568\ See Elliot Crigger et al., Trustworthy Augmented 
Intelligence in Health Care, 46 J. Med. Sys., Jan. 2022, at p. 6, 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8755670/pdf/10916_2021_Article_1790.pdf (discussing that physicians are expected 
to understand the ``benefits, risks, indications, appropriateness, 
and alternatives'' of using AI tools and that tools should not be 
used if the physician is not able to understand enough about the 
tool to use it in their practice).
    \569\ See U.S. Dep't of Just., Algorithms, Artificial 
Intelligence, and Disability Discrimination in Hiring (2022), 
https://beta.ada.gov/ai-guidance/ (discussing how algorithms and 
artificial intelligence in hiring technologies may result in 
unlawful discrimination against certain groups of applicants, 
including people with disabilities); U.S. Equal Emp't Opportunity 
Comm'n, The Americans with Disabilities Act and the Use of Software, 
Algorithms, and Artificial Intelligence to Assess Job Applicants and 
Employees, EEOC-NVTA-2022-2 (2022), https://www.eeoc.gov/laws/guidance/americans-disabilities-act-and-use-software-algorithms-and-artificial-intelligence (discussing how employers' use of software 
that relies on algorithmic decision-making may violate existing 
requirements under Title I of the ADA).

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[[Page 47883]]

    Clinical algorithmic tools are pervasive, and a covered entity may 
be unaware of any discrimination that may result from their reliance on 
such a tool. We note that individual providers are not likely to have 
designed the clinical algorithms that augment their clinical decision-
making. However, covered entities are responsible for ensuring that any 
action they take based on a clinical algorithm does not result in 
discrimination prohibited by this part, irrespective of whether they 
played a role in designing the algorithm.\570\ The fact that a covered 
entity did not design the algorithm or does not have knowledge about 
how the tool works does not alleviate their responsibility to ensure 
that they do not take actions that result in discrimination. In sum, 
this part does not hold covered entities liable for clinical algorithms 
that they did not develop but holds entities liable under this proposed 
section for the decisions they make in reliance on such algorithms.
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    \570\ See U.S. Dep't of Just., supra note 569, at pp. 2-3 
(discussing how an employer's use of algorithms and artificial 
intelligence in hiring technologies may still lead to unlawful 
discrimination even where the employer does not mean to 
discriminate); U.S. Equal Emp't Opportunity Comm'n, Americans with 
Disabilities Act and the Use of Software, supra note 569, at p. 6 
(discussing how an employers' use of software that relies on 
algorithmic decision-making may violate existing requirements under 
Title I of the ADA and that an employer may still be liable under 
the ADA for its use of such tools even if the tools are designed or 
administered by another entity).
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    We recognize that this is a complex and evolving area that may be 
challenging for covered entities to evaluate for potential violations 
of Section 1557. The Department shares a responsibility in working with 
recipients, Department components, and Title I entities to identify and 
prevent discrimination based upon the use of clinical decision tools 
and technological innovation in health care. Covered entities should 
take steps to ensure that the use of clinical algorithms does not 
result in discrimination on the basis of race, color, national origin, 
sex, age, or disability in their health programs and activities.\571\ 
For example, covered entities may choose to establish written policies 
and procedures governing how information from clinical algorithms will 
be used in decision-making; monitor any potential impacts; and train 
staff on the proper use of such systems in decision-making.\572\
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    \571\ For information on promising practices to reduce bias and 
discrimination in clinical algorithms, see generally Fed. Trade 
Comm'n, Using Artificial Intelligence and Algorithms (Apr. 8, 2020), 
https://www.ftc.gov/news-events/blogs/business-blog/2020/04/using-artificial-intelligence-algorithms; Fed. Trade Comm'n, Aiming for 
Truth, Fairness, and Equity in Your Company's Use of AI (Apr. 19, 
2021), https://www.ftc.gov/news-events/blogs/business-blog/2021/04/aiming-truth-fairness-equity-your-companys-use-ai; Fed. Trade 
Comm'n, Big Data: A Tool for Inclusion or Exclusion? (Jan. 2016), 
https://www.ftc.gov/system/files/documents/reports/big-data-tool-inclusion-or-exclusion-understanding-issues/160106big-data-rpt.pdf; 
Nat'l Inst. of Standards & Tech., NIST Special Publ'n 1270, Towards 
a Standard for Identifying and Managing Bias in Artificial 
Intelligence (2022), https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.1270.pdf.; Gen. Accountability Off., 
Artificial Intelligence: An Accountability Framework for Federal 
Agencies and Other Entities (2021), https://www.gao.gov/assets/gao-21-519sp.pdf; U.S. Food & Drug Admin., Good Machine Learning 
Practice for Medical Device Development: Guiding Principles (Oct. 
2021), https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles; U.S. Equal Emp't Opportunity Comm'n, Americans 
with Disabilities Act and the Use of Software, supra note 569, at 
pp. 12-14; Takshi, supra note 546, at 234-39; Robert Bartlett et 
al., Algorithmic Discrimination and Input Accountability Under the 
Civil Rights Acts (preprint) (2020), https://ssrn.com/abstract=3674665; Nicol Turner Lee et al., Brookings Inst., 
Algorithmic Bias Detection and Mitigation: Best Practices and 
Policies to Reduce Consumer Harms (2019), https://www.brookings.edu/research/algorithmic-bias-detection-and-mitigation-best-practices-and-policies-to-reduce-consumer-harms/; Ada Lovelace Inst., AI Now 
Inst. & Open Gov't P'ship, Executive Summary: Algorithmic 
Accountability for the Public Sector, (2021), https://www.opengovpartnership.org/wp-content/uploads/2021/08/executive-summary-algorithmic-accountability.pdf; Ziad Obermeyer et al., 
Chicago Booth, Ctr. For Applied Artificial Intelligence, Algorithmic 
Bias Playbook (2021), https://www.chicagobooth.edu/research/center-for-applied-artificial-intelligence/research/algorithmic-bias/playbook; Mei Chen & Michel Decary, Artificial Intelligence in 
Healthcare: An Essential Guide for Health Leaders, 33 Healthcare 
Mgmt. F. 10, (2020), https://pubmed.ncbi.nlm.nih.gov/31550922/; 
Genevieve Smith & Ishita Rustagi, Berkeley Haas Ctr. for Equity, 
Gender, & Leadership, Mitigating Bias in Artificial Intelligence: An 
Equity Fluent Leadership Playbook (2020), https://haas.berkeley.edu/wp-content/uploads/UCB_Playbook_R10_V2_spreads2.pdf; Trishan Panch 
et al., Artificial Intelligence and Algorithmic Bias: Implications 
for Health Systems, 9 J. Global Health, Dec. 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875681/pdf/jogh-09-020318.pdf.
    \572\ See, e.g., Takshi, supra note 546, at 234-35; Nat'l Inst. 
of Standards & Tech., NIST Special Publ'n 1270, supra note 571, at 
pp. 42-47; Gen. Accountability Off., supra note 571.
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    The American Medical Association (AMA) has been active in this area 
and issued a framework to guide the health care community in 
evaluating, integrating, using, and monitoring augmented intelligence 
systems that enhance capabilities of human decision-making with 
computational methods and systems (which includes clinical algorithm 
tools).\573\ We recognize that ``augmented intelligence systems'' are 
different in scope from clinical algorithm tools, yet believe that the 
AMA research provides helpful guidance when covered entities are 
considering the use of clinical algorithm tools. The AMA framework 
suggests that providers should understand enough about the tools they 
are using in order to evaluate, select, and implement them, and should 
forgo the use of such tools if the provider does not adequately 
understand how they work.\574\ Providers should also ensure that the 
tool addresses a meaningful clinical goal and works as intended, 
develop a clear protocol to identify and correct for potential bias, 
have the ability to override the tool, ensure meaningful oversight is 
in place for ongoing monitoring, and ensure clear protocols exist for 
enforcement and accountability, including a clear protocol to ensure 
equitable implementation.\575\ When evaluating a tool, a provider 
should ask whether the tool was properly validated and validated for 
the specific case and use, whether it was tested in different 
populations to identify hidden bias, and whether it allows barriers to 
access to be found and rectified, among other things.\576\
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    \573\ See, e.g., Crigger, Trustworthy Augmented Intelligence in 
Health Care, supra note 568.
    \574\ Id. at p. 6.
    \575\ Id.
    \576\ Id. at pp. 7-8.
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    Given the increasing reliance on clinical algorithms to inform 
decision-making in the area of health care, and the reality that the 
implementation of these tools may be discriminatory under Section 1557, 
the Department proposes Sec.  92.210 to make explicit that covered 
entities are prohibited from discriminating through the use of clinical 
algorithms on the basis of race, color, national origin, sex, age, or 
disability under Section 1557. If OCR receives a complaint alleging 
discrimination resulting from the use of a clinical algorithm in 
decision-making against a covered entity, it will conduct a fact-
specific analysis of the allegation. OCR's analysis will consider, 
among other things, what decisions and actions were taken by the 
covered entity in reliance upon a clinical algorithm in its decision-
making, and what measures the covered entity took to ensure that its 
decisions and actions resulting from using a clinical algorithm were 
not discriminatory. OCR would, as required by statute and this proposed 
rule, work with the covered entity to achieve voluntary 
compliance.\577\
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    \577\ See 42 U.S.C. 2000d-1 (enforcement action may not be taken 
until the department has ``determined that compliance cannot be 
secured by voluntary means''); 18116(a) (adopting the enforcement 
mechanisms provided for an available under Title VI).

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[[Page 47884]]

    OCR is committed to working with partners throughout the Department 
and other Executive Agencies \578\ to develop responsive technical 
assistance to support covered entities in complying with their civil 
rights obligations. We seek comment on the inclusion of this provision; 
whether it is appropriately limited to clinical algorithms or should 
include additional forms of automated or augmented decision-making 
tools or models, such as artificial intelligence or machine learning; 
whether a provision such as this should include more specificity, 
including actions covered entities should take to mitigate potential 
discriminatory outcomes and what those actions should be; what 
promising practices could be used by covered entities to ensure that 
clinical algorithms are not discriminatory; and what type of technical 
assistance or guidance would be most helpful to covered entities for 
compliance with this section. We seek comment on what factors would be 
relevant to determine whether a covered entity is in violation of this 
provision and what possible defenses a covered entity may have when 
using a clinical algorithm in its decision-making that results in 
discrimination. We seek comment on governance measures, such as 
transparency mechanisms, reporting requirements, and impact 
assessments, that would assist in compliance with civil rights 
obligations. We also seek comment on what types of clinical algorithms 
are being used in covered health programs and activities; how such 
algorithms are being used by covered entities; whether they are more 
prevalent in certain health settings; when clinical algorithms and 
variables based on protected grounds under Section 1557 are useful (or 
not); and what mechanisms are in place or should be in place to detect, 
address, and remediate possible discriminatory effects of their usage. 
Finally, we seek comment requesting resources and recommendations on 
how to identify and mitigate discrimination resulting from the usage of 
clinical algorithms and other forms of automated decision-making tools 
and models.
---------------------------------------------------------------------------

    \578\ Many Federal agencies are taking steps to address 
discrimination in clinical algorithms and artificial intelligence. 
See, e.g., U.S. Dep't of Health & Human Servs., Agency for 
Healthcare Research & Quality, 86 FR 12948 (Mar. 5, 2021) (Request 
for Information on the Use of Clinical Algorithms That Have the 
Potential to Introduce Racial/Ethnic Bias Into Healthcare Delivery); 
.S. Dep't of Justice, Nat'l Inst. of Just., Predicting Recidivism: 
Continuing To Improve the Bureau of Prisons' Risk Assessment Tool, 
PATTERN (Apr. 19, 2022), https://nij.ojp.gov/topics/articles/predicting-recidivism-continuing-improve-bureau-prisons-risk-assessment-tool; Kristen Clarke, Assistant Att'y Gen., U.S. Dep't of 
Just., Keynote Address at the Dep't. of Com.'s Nat'l Telecomm. & 
Info. Admin.'s Virtual Listening Session (Dec. 14, 2021), https://www.justice.gov/opa/speech/assistant-attorney-general-kristen-clarke-delivers-keynote-ai-and-civil-rights-department; Press 
Release, U.S. Equal Emp't Opportunity Comm'n, EEOC Launches 
Initiative on Artificial Intelligence and Algorithmic Fairness (Oct. 
28, 2021), https://www.eeoc.gov/newsroom/eeoc-launches-initiative-artificial-intelligence-and-algorithmic-fairness; Bureau of Consumer 
Fin. Protection, Adverse Action Notification Requirements in 
Connection with Credit Decisions Based on Complex Algorithms (May 
26, 2022), https://www.consumerfinance.gov/compliance/circulars/circular-2022-03-adverse-action-notification-requirements-in-connection-with-credit-decisions-based-on-complex-algorithms/; Bd. 
of Governors of the Fed. Reserve System, Bureau of Consumer Fin. 
Protection, Fed. Deposit Ins. Corp., Nat'l Credit Union Admin., & 
Office of the Comptroller of the Currency, 86 FR 16837 (Mar. 31, 
2021) (Request for Information and Comment on Financial 
Institutions' Use of Artificial Intelligence, Including Machine 
Learning, Identifying Unlawful Discrimination as a Potential Risk of 
Using Artificial Intelligence); Fed. Trade Comm'n, Using Artificial 
Intelligence and Algorithms, supra note 571; Fed. Trade Comm'n, 
Aiming for Truth, Fairness, and Equity in Your Company's Use of AI, 
supra note 571; U.S. Dep't of Com., Nat'l Inst. of Standards & 
Tech., supra note 571.
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Nondiscrimination in the Delivery of Health Programs and Activities 
Through Telehealth Services (Sec.  92.211)

    Proposed Sec.  92.211 specifically addresses nondiscrimination in 
the delivery of health programs and activities through telehealth 
services. Telehealth is a means by which covered entities provide their 
health programs and activities, and this provision clarifies the 
affirmative duty that covered entities have to not discriminate in 
their delivery of such services through telehealth. This duty includes 
ensuring that such services are accessible to individuals with 
disabilities and provide meaningful program access to LEP individuals. 
Specifically, proposed Sec.  92.211 provides that a covered entity must 
not, in delivery of its health programs and activities through 
telehealth services, discriminate on the basis of race, color, national 
origin, sex, age, or disability. Telehealth has not been addressed in 
previous Section 1557 rulemaking but has become widely used as a result 
of the COVID-19 pandemic.
    As defined by the Health Resources Services Administration within 
the Department, telehealth means the use of electronic information and 
telecommunications technologies to support long-distance clinical 
health care, patient and professional health-related education, public 
health, and health administration.\579\ Technologies include 
videoconferencing, the internet, store-and-forward imaging, streaming 
media, and terrestrial and wireless communications.\580\
---------------------------------------------------------------------------

    \579\ What Is Telehealth?, U.S. Dep't of Health & Human Servs., 
Health Rsch. & Servs. Admin. (last updated Mar. 2022), https://www.hrsa.gov/rural-health/telehealth/what-is-telehealth.
    \580\ What Is Telehealth? How Is It Different from 
Telemedicine?, HealthIT.gov, (last updated Oct. 17, 2019), https://www.healthit.gov/faq/what-telehealth-how-telehealth-different-telemedicine.
---------------------------------------------------------------------------

    Since 2016, the use of telemedicine at self-contained clinics and 
the use of telehealth provided to patients at home has grown 
significantly. This is particularly true of the use of telehealth at 
home due to the COVID-19 pandemic, with one recent study showing a 63-
fold increase in Medicare telehealth utilization during the 
pandemic.\581\ The increased availability of telehealth has been a 
benefit to many, including transgender individuals who have been able 
to access gender-affirming care without geographical constraints or 
fear of stigma and discrimination.\582\ However, studies also indicate 
disparities in access based on race and disability. One study found 
``significant'' racial disparities in telehealth use during the COVID-
19 pandemic, which the authors believe may lead to the worsening of 
pre-existing health disparities.\583\
---------------------------------------------------------------------------

    \581\ Lok Wong Samson et al., U.S. Dep't of Health & Human 
Servs., Off. of the Assistant Sec'y for Planning & Evaluation, Issue 
Brief: Medicare Beneficiaries' Use of Telehealth Services in 2020: 
Trends by Beneficiary Characteristics and Location (2021), https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf.
    \582\ Ole-Petter R. Hamnvik et al., Telemedicine and Inequities 
in Health Care Access: The Example of Transgender Health, 
Transgender Health (pre-print) (2022), https://www.liebertpub.com/doi/epdf/10.1089/trgh.2020.0122.
    \583\ Robert P. Pierce & James J. Stevermer, Disparities in the 
Use of Telehealth at the Onset of the COVID-19 Public Health 
Emergency, J. Telemed & Telecare, Oct. 21, 2020, at p. 5, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7578842/pdf/10.1177_1357633X20963893.pdf.
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    One study in 2016 on telehealth among Medicare beneficiaries found 
that individuals with disabilities accounted for 65 percent of 
telehealth use and 66 percent of all telehealth services. Individuals 
with disabilities using telehealth increased by 37.7 percent between 
the years 2014 and 2016. During that same time period, individuals with 
disabilities accounted for an increase of 53.7 percent of total 
telehealth services used.\584\ Another more recent study looked at the 
broader

[[Page 47885]]

noninstitutionalized population and found that 39.8 percent of 
individuals with disabilities used telehealth during the second year of 
the pandemic.\585\
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    \584\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & 
Medicaid Servs., Information on Medicare Telehealth Report (2018), 
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Information-on-Medicare-Telehealth-Report.pdf.
    \585\ Carli Friedman & Laura VanPuymbrouck, Telehealth Use by 
Persons with Disabilities During the COVID-19 Pandemic, 13 Int'l J. 
Telerehabilitation 2 (2021), https://doi.org/10.5195/ijt.2021.6402.
---------------------------------------------------------------------------

    While there are benefits to be gained from telehealth for 
individuals with disabilities, including lower cost of care and 
transportation costs, lower exposure to communicable diseases, and 
access to specialized care including care provided across state lines, 
barriers persist around access.\586\ Some of these challenges include 
inaccessible telehealth platforms and other barriers to communication 
with individuals who are deaf, blind, or have cognitive 
disabilities.\587\ For example, telehealth platforms have been found to 
not have the ability to incorporate third-party services, including 
real-time captioning and any additional video feeds that may be 
required for the provision of qualified interpreters, direct service 
providers, or supportive decision makers.\588\ Telehealth may also not 
include considerations for usability, compatibility with external 
assistive technology, and reduction on cognitive burden.\589\ Remote 
patient monitoring devices used in telehealth may be challenging for 
individuals with manual dexterity or physical mobility disabilities to 
use.\590\ Telehealth platforms may also not be compatible with screen 
reading software.\591\ Purportedly accessible mobile health (mHealth) 
applications, such as applications offered by healthcare organizations 
to their patients, have also been found to be inaccessible.\592\
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    \586\ Thiru M. Annaswamy et al., Telemedicine Barriers and 
Challenges for Persons with Disabilities: COVID-19 and Beyond, 13 
Disability Health J., July 9, 2020, at p. 2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7346769/pdf/main.pdf; Daniel 
Young & Elizabeth Edwards, Telehealth and Disability: Challenges and 
Opportunities for Care, Nat'l Health Educ. Law Program, (May 6, 
2020), https://healthlaw.org/telehealth-and-disability-challenges-and-opportunities-for-care/.
    \587\ Annaswamy, supra note 586, at p. 2; Young, supra note 586; 
Rupa S. Valdez et al., Ensuring Full Participation of People with 
Disabilities in an Era of Telehealth, 28 J. Am. Med. Inform. Ass'n 
389 (Feb. 2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717308/.
    \588\ Valdez, supra note 587.
    \589\ Id.; Daihua X. Yu et al., Accessibility Needs and 
Challenges of a mHealth System for Patients with Dexterity 
Impairments, 12 Disabil. Rehabil. Assist. Technol. 56-64 (2015), 
https://doi.org/10.3109/17483107.2015.1063171; Erin Beneteau et al., 
Telehealth Experiences of Providers and Patients Who Use 
Augmentative and Alternative Communication, 29 J. Am. Med. Inform. 
Ass'n 481-488 (2022), https://doi.org/10.1093/jamia/ocab273.
    \590\ Annaswamy, supra note 586, at p. 2.
    \591\ Id.; Young, supra note 586; Valdez, supra note 587.
    \592\ Keith M. Christensen & Jill Bezyak., Rocky Mountain ADA 
Center, Telehealth Use Among Rural Individuals with Disabilities 
(2020), https://rockymountainada.org/sites/default/files/2020-02/Rural%20Telehealth%20Rapid%20Response%20Report.pdf; Lauren R. Milne 
et al., The Accessibility of Mobile Health Sensors for Blind Users, 
2 J. Tech. Persons Disabilities 166-175 (2014), https://scholarworks.calstate.edu/downloads/xs55mg57v#page=173.
---------------------------------------------------------------------------

    Although telehealth services are a means by which a covered entity 
may provide access to a health program or activity, and thus are 
clearly covered under Section 1557 and this proposed rule, the 
Department has decided to also include a specific provision regarding 
telehealth due to the increasing prevalence of telehealth and the 
numerous related accessibility challenges. Thus, covered entities are 
required to provide telehealth services in a manner that does not 
discriminate on a protected basis under Section 1557, including through 
the accessibility of telehealth platforms (proposed Sec.  92.204) and 
by providing effective communication for individuals with disabilities 
through the provision of appropriate auxiliary aids and services 
(proposed Sec.  92.202) and language assistance services for LEP 
individuals (proposed Sec.  92.201). Such requirements broadly apply to 
all health programs and activities provided, including those via 
telehealth. Such services would include communications about the 
availability of telehealth services, the process for scheduling 
telehealth appointments, (including the process for accessing on-demand 
unscheduled telehealth calls), and the telehealth appointment itself.
    OCR seeks comment on this approach and whether covered entities and 
others would benefit from a specific provision addressing accessibility 
in telehealth services, for individuals with disabilities and LEP 
individuals. We seek comment on what such a provision should include, 
and why the proposed provisions related to ICT, effective communication 
for individuals with disabilities, and meaningful access for LEP 
individuals are insufficient. Further, we seek comment on challenges 
with accessibility specific to telehealth and recommendations for 
telehealth accessibility standards that would supplement the ICT 
standards (proposed Sec.  92.204) and effective communication 
requirements (proposed Sec.  92.202) of this part. We encourage 
commenters to consider the range of technology available for accessing 
telehealth, including user-friendly design, as well as security and 
privacy requirements (for example, when using public Wi-Fi access).

Subpart D--Procedures

Enforcement Mechanisms (Sec.  92.301)

    Proposed Sec.  92.301 provides that the enforcement mechanisms 
available for and provided under Title VI of the Civil Rights Act of 
1964, Title IX of the Education Amendments of 1972, Section 504 of the 
Rehabilitation Act of 1973, and the Age Discrimination Act of 1975 
shall apply for purposes of Section 1557 as implemented by this part. 
This is consistent with the statutory text of Section 1557, which 
provides that ``[t]he enforcement mechanisms provided for and available 
under such title VI, title IX, section 794, or such Age Discrimination 
Act shall apply for purposes of violations of this subsection.'' \593\ 
Additionally, this provision is consistent with the 2016 Rule at former 
Sec.  92.301(a) and Sec.  92.5(a) of the 2020 Rule. Enforcement 
mechanisms include a private right of action, as recognized by the 
Supreme Court in Cummings v. Premier Rehab Keller, P.L.L.C..\594\
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    \593\ 42 U.S.C. 18116.
    \594\ 142 S. Ct. 1562, 1569-70 (2022) (``it is `beyond dispute 
that private individuals may sure to enforce' [Section 504 and 
Section 1557]'').
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Notification of Views Regarding Application of Federal Conscience and 
Religious Freedom Laws (Sec.  92.302)

    In proposed Sec.  92.302, the Department specifically addresses the 
application of Federal conscience and religious freedom laws. This is a 
newly proposed provision, as neither the 2016 nor 2020 Rule provided a 
specific means for recipients to notify the Department of their views 
regarding the application of Federal conscience or religious freedom 
laws.
    Proposed paragraph (a) provides that a recipient may raise with the 
Department its belief that the application of a specific provision or 
provisions of this regulation as applied to it would violate Federal 
conscience or religious freedom laws. Such laws include but are not 
limited to the Coats-Snowe Amendment, Church Amendments, RFRA, section 
1553 of the ACA, section 1303 of the ACA, and the Weldon Amendment. 
Recipients are also reminded that they can file complaints regarding 
Federal conscience laws with OCR, as provided in 45 CFR part 88.
    Proposed paragraph (b) provides that once OCR receives a 
notification pursuant to proposed paragraph (a), OCR shall promptly 
consider those views in responding to any complaints

[[Page 47886]]

or otherwise determining whether to proceed with any investigation or 
enforcement activity regarding that recipient's compliance with the 
relevant provisions of this regulation. Any relevant ongoing 
investigation or enforcement activity regarding the recipient shall be 
held in abeyance until a determination has been made under paragraph 
(c). Considering recipients' religious- or conscience-based concerns in 
the context of an open case (i.e., when OCR first has cause to consider 
the recipient's compliance), will allow OCR to make an informed, case-
by-case decision and, where applicable, protect a recipient's 
conscience or religious freedom rights. Similarly, holding ongoing 
investigations and enforcement activity in abeyance is designed to 
alleviate the burden of a recipient having to respond to an 
investigation or enforcement action until a recipient's objection has 
been considered by OCR.
    Proposed paragraph (c) makes clear OCR's discretion to determine at 
any time whether a recipient is wholly exempt from or entitled to a 
modification of the application of certain provisions of this part, or 
whether modified application of the provision is required under a 
Federal conscience or religious freedom law. Proposed paragraph (c) 
requires that, in determining whether a recipient is exempt from the 
application of the specific provision or provisions raised in its 
notification, OCR must assess whether there is a sufficiently concrete 
factual basis for making a determination and apply the applicable legal 
standards of the referenced statute. Proposed paragraph (c) further 
provides that, upon making a determination regarding whether a 
particular recipient is exempt from--or subject to a modified 
requirement under--a specific provision of this part, OCR will 
communicate that determination to the recipient.
    Proposed paragraph (d) provides that if OCR determines that a 
recipient is entitled to an exemption or modification of the 
application of certain provisions of this rule based on the application 
of such laws, that determination does not otherwise limit the 
application as to any other provision of this part to the recipient.
    OCR maintains an important civil rights interest in the proper 
application of Federal conscience and religious freedom protections. In 
enforcing Section 1557, OCR is thus committed to complying with RFRA 
and all other legal requirements. The Department believes that the 
proposed approach in this section will assist the Department in 
fulfilling that commitment by providing the opportunity for recipients 
to raise concerns with the Department, such that the Department can 
determine whether an exemption or modification of the application of 
certain provisions is appropriate under the corresponding Federal 
conscience or religious freedom law. As noted above, the Department 
also maintains a strong interest in taking a case-by-case approach to 
such determinations, which will allow it to account for any harm an 
exemption could have on third parties \595\ and, in the context of 
RFRA, to consider whether the application of any substantial burden on 
a person's exercise of religion is in furtherance of a compelling 
interest and is the least restrictive means of advancing that 
compelling interest.\596\
---------------------------------------------------------------------------

    \595\ See Cutter v. Wilkinson, 544 U.S. 709, 720 (2005) (in 
addressing religious accommodation requests, ``courts must take 
adequate account of the burdens a requested accommodation may impose 
on nonbeneficiaries'').
    \596\ Cf. Gonzales v. O Centro Esp[iacute]rita Beneficente 
Uni[atilde]o do Vegetal, 546 U.S. 418, 439 (2006) (``[C]ourts should 
strike sensible balances, pursuant to a compelling interest test 
that requires the Government to address the particular practice at 
issue.'') (emphasis added).
---------------------------------------------------------------------------

    The Department seeks comment on this approach, including whether 
such a provision should include additional procedural information, the 
potential burdens of such a provision on recipients and potential third 
parties, and additional factors that the Department should take into 
account when considering the relationship between Federal conscience 
and religious freedom laws and Section 1557's civil rights protections. 
We also seek comment on what alternatives, if any, the Department 
should consider.

Procedures for Health Programs and Activities Conducted by Recipients 
and State Exchanges (Sec.  92.303)

    Proposed Sec.  92.303 provides for the enforcement procedures 
related to health programs and activities conducted by recipients and 
State Exchanges, consistent with former Sec.  92.302 of the 2016 Rule. 
The 2020 Rule does not include this provision, and instead relies on 
Sec.  92.5, the general Enforcement Mechanisms section discussed above, 
which includes a paragraph (b) that notes that the Director has been 
delegated authority to enforce Section 1557, including the authority to 
conduct investigations and compliance reviews, make enforcement 
referrals to the DOJ, and take any other appropriate remedial action 
the Director deems necessary.
    The 2020 Rule does not make sufficiently clear for either covered 
entities or individuals protected by Section 1557 what procedures will 
apply in OCR's enforcement of Section 1557. As OCR has clear procedures 
that apply under Title VI, Title IX, Section 504, and the Age Act, OCR 
similarly needs to have clear procedures that apply under Section 1557.
    Proposed paragraph (a) applies the procedural provisions in the 
Title VI regulation with respect to administrative enforcement actions 
concerning discrimination on the basis of race, color, national origin, 
sex, and disability under Section 1557. Since the effective date of the 
ACA, OCR has enforced Section 1557 according to the procedural 
provisions of Title VI. The Title VI procedures have applied to 
discrimination on the basis of race, color, and national origin for 
decades, as well as to discrimination on the basis of sex and 
disability, as the Title VI procedures have been incorporated into the 
regulations implementing Title IX and Section 504.\597\ In the 
Department's view, therefore, it is logical and appropriate to 
similarly apply these procedures in enforcement with respect to race, 
color, national origin, sex, and disability discrimination under 
Section 1557.
---------------------------------------------------------------------------

    \597\ 45 CFR 84.61; Sec.  86.71.
---------------------------------------------------------------------------

    Proposed paragraph (b) applies Age Act procedures to enforce 
Section 1557 with respect to age discrimination complaints against 
recipients and State Exchanges. The Age Act has its own set of 
procedures, and OCR has been applying those procedures in enforcement 
with respect to age discrimination under Section 1557 from the 
effective date of the ACA to the present.
    Proposed paragraph (c) provides that when a recipient fails to 
provide OCR with requested information in a timely, complete, and 
accurate manner, OCR may, after attempting to reach a voluntary 
resolution, find noncompliance with Section 1557 and initiate the 
appropriate enforcement procedure, found at 45 CFR 80.8. This provision 
was found at former Sec.  92.302(c) in the 2016 Rule. The 2020 Rule 
repealed the provision, stating that when a recipient fails to provide 
OCR with requested information in a timely, complete, and accurate 
manner, OCR may find noncompliance with Section 1557 and initiate 
appropriate enforcement procedures, absent the need to attempt to 
effectuate voluntary compliance. The preamble to the 2020 Rule stated 
that the existing authorities already contain parallel provisions.\598\ 
Yet, the preamble cites a number of provisions that do not support the 
statement but rather address seeking

[[Page 47887]]

resolution through voluntary means when there is a failure to comply 
with the regulation.\599\ We believe that the provision we propose at 
paragraph (c) is helpful in clarifying for recipients and individuals 
covered by Section 1557 that, should OCR's attempt to effectuate 
voluntary compliance be unsuccessful, the consequences of failing to 
provide OCR with information necessary for OCR to determine compliance 
with the law may include the initiation of the appropriate enforcement 
procedures, found at 45 CFR 80.8.
---------------------------------------------------------------------------

    \598\ 85 FR 37160, 37203 (June 19, 2020).
    \599\ Id. at n. 253 (discussing 45 CFR 80.7(d) (which requires 
the Department to seek resolution through informal means where there 
is a failure to comply with the regulation); Sec.  80.8(c)(1) (note: 
Sec.  80.8(c) does not include a paragraph (1), but Sec.  80.8(c) 
requires the Department to seek voluntary compliance and take other 
steps prior to taking action to terminate Federal financial 
assistance); Sec.  84.6(b) (stating the right of a recipient to take 
voluntary action to overcome the effects of conditions that have 
resulted in limited participation by qualified individuals with 
disabilities); Sec.  90.49(c) (stating that the provision of special 
benefits to children or the elderly is generally presumed to be 
voluntary affirmative action)).
---------------------------------------------------------------------------

Procedures for Health Programs and Activities Administered by the 
Department (Sec.  92.304)

    Proposed Sec.  92.304 addresses procedures for all claims of 
discrimination against the Department under Section 1557 or this part. 
Proposed paragraph (b) makes the existing procedures under the Section 
504 federally conducted regulation at 45 CFR 85.61 through 85.62 
applicable to all such claims under Section 1557 for all protected 
bases (i.e., race, color, national origin, sex, age, and disability). 
This is the only procedure that is currently in place for any 
discrimination claims against the Department under the laws that OCR 
enforces. Proposed paragraph (c) requires the Department to provide OCR 
access to information relevant to determining compliance with Section 
1557 or this part, and proposed paragraph (d) prohibits the Department 
from retaliating against an individual or entity for the purpose of 
interfering with any right secured by Section 1557 or this part, or 
because such individual or entity has participated in an investigation, 
proceeding, or hearing under Section 1557 or this part. This is 
consistent with the 2016 Rule at former Sec.  92.303.
    The 2020 Rule does not include any specific provision for the 
processing of claims of race, color, national origin, sex, age, or 
disability discrimination against any covered Departmental program, 
having rescinded former Sec.  92.303 in its entirety. The other 
statutes that OCR enforces--Title VI, Title IX, and the Age Act--do not 
directly apply to the Department. The 2016 Rule adopted the Section 504 
procedure for all claims of discrimination against any Departmental 
health program under Section 1557, a procedure that has been in place 
for decades, is familiar to the Department and has worked effectively. 
We believe it is important in this rule to identify the procedure that 
we will use in enforcing Section 1557 with respect to Departmental 
health programs and activities and therefore are proposing to do so by 
reinstating the provision from the 2016 Rule at proposed paragraph (b).
    The 2020 Rule also does not include the provision of the 2016 Rule 
that required the Department to provide OCR access to information 
necessary to determine compliance with Section 1557. The reason 
provided was that ``regulations implementing Section 1557's four 
underlying statutes already contain provisions addressing access to 
review of covered entities' records of compliance,'' \600\ and thus the 
language in the 2016 Rule to this effect was unnecessary. However, 
apart from the Section 504 regulation applicable to the Department, 
none of the other regulations apply to the Department; therefore, 
provisions under those regulations do not apply to the Department. 
Consequently, the Department is proposing to reinstate this provision 
at proposed Sec.  92.304(c).
---------------------------------------------------------------------------

    \600\ 85 FR 37203.
---------------------------------------------------------------------------

    The 2020 Rule also does not include a prohibition on retaliation 
that applies to the Department, which was provided at former Sec.  
[thinsp]92.303(d). In repealing this provision, the preamble to the 
2020 Rule stated that ``regulations implementing Section 1557's four 
underlying statutes already contain provisions against intimidation and 
retaliation as appropriate . . . The language in the 2016 Rule to this 
effect was unnecessary.'' \601\ As we have noted, regulations 
implementing three of the four underlying regulations do not apply to 
the Department; therefore, we now disagree with the Department's 
reasoning in 2020.
---------------------------------------------------------------------------

    \601\ Id.
---------------------------------------------------------------------------

    We are including a retaliation provision at proposed paragraph (d) 
to make clear that the Department, including Federally-facilitated 
Exchanges, must not intimidate, threaten, coerce, retaliate, or 
otherwise discriminate against any individual or entity for the purpose 
of interfering with any right or privilege secured by Section 1557 or 
this part, or because such individual or entity has made a complaint, 
testified, assisted, or participated in any manner in an investigation, 
proceeding or hearing under Section 1557 or this part. The ADA 
similarly prohibits such retaliation, interference, coercion, and 
intimidation,\602\ and, as discussed supra in relation to proposed 
Sec.  92.3 (relationship to other laws), the ADA and Section 504 are 
generally understood to impose substantially the same requirements. The 
Department is thus prohibited from engaging in retaliation, 
intimidation, coercion, or interferences with rights under Section 504. 
We are proposing to similarly prohibit the Department from such 
discrimination under Section 1557. Further, this proposed provision 
would hold the Department and Federally-facilitated Exchanges to the 
same standards to which the Department holds all recipients of Federal 
financial assistance.
---------------------------------------------------------------------------

    \602\ 42 U.S.C. 12203.
---------------------------------------------------------------------------

IV. Change in Interpretation--Medicare Part B Meets the Definition of 
Federal Financial Assistance

    The Department's longstanding position has been that Medicare Part 
B funding does not constitute Federal financial assistance for the 
purpose of Title VI, Title IX, Section 504, the Age Act, and Section 
1557.\603\ For the reasons discussed below, and after reevaluating the 
Department's position on Medicare Part B, we are proposing to change 
that position and treat Medicare Part B funds as Federal financial 
assistance to the providers and suppliers subsidized by those funds.
---------------------------------------------------------------------------

    \603\ 81 FR 31375, 31383 (May 18, 2016).
---------------------------------------------------------------------------

    To constitute Federal financial assistance, the Federal funds or 
assistance must confer a benefit or subsidy on the recipient; 
compensation from the government for services provided to the 
government is not Federal financial assistance.\604\ Further, Congress 
or the department administering the funds must intend for the 
assistance to subsidize the entity.\605\
---------------------------------------------------------------------------

    \604\ See, e.g., DeVargas v. Mason & Hanger-Silas Mason Co., 
Inc., 911 F.2d 1377, 1382 (9th Cir. 1990), cert. denied, 498 U.S. 
1074 (1991); Jacobson v. Delta Airlines, 742 F.2d 1202, 1209 (9th 
Cir. 1984); Hunter. v. D.C., 64 F. Supp. 3d 158, 172 (D.D.C. 2020).
    \605\ U.S. Dep't of Transport. v. Paralyzed Veterans Ass'n, 477 
U.S. 597, 606-07 (1986); Grove City Coll. v. Bell, 465 U.S. 555, 564 
(1984).
---------------------------------------------------------------------------

    Building on these principles, this rule proposes to define 
``Federal financial assistance,'' at proposed Sec.  92.4, in relevant 
part as ``any grant, loan, credit, subsidy, contract (other than a 
procurement contract but including a contract of insurance), or any 
other

[[Page 47888]]

arrangement by which the Federal Government provides assistance or 
otherwise makes assistance available in the form of: (i) Funds; (ii) 
Services of Federal personnel; or (iii) Real and personal property or 
any interest in or use of such property, including: (A) Transfers or 
leases of such property for less than fair market value or for reduced 
consideration; and (B) Proceeds from a subsequent transfer or lease of 
such property if the Federal share of its fair market value is not 
returned to the Federal Government.'' This proposed definition is 
similar to the definition in HHS' regulations implementing the Title 
VI, Title IX, Section 504, and the Age Act, with the exception of the 
phrase ``otherwise makes assistance available.'' \606\ Similar to the 
Department's definition of ``recipient'' under the implementing 
regulations for Title VI, Title IX, Section 504, and the Age Act, the 
Department proposes to define ``recipient'' as ``any State or its 
political subdivision, or any instrumentality of a State or its 
political subdivision, any public or private agency, institution, or 
organization, or other entity, or any person, to whom Federal financial 
assistance is extended directly or indirectly, including any subunit, 
successor, assignee, or transferee of a recipient, but such term does 
not include any ultimate beneficiary.'' \607\
---------------------------------------------------------------------------

    \606\ 45 CFR 80.13(f) (Title VI); Sec.  84.3(h) (Section 504); 
Sec.  86.2(g) (Title IX); Sec.  91.4 (Age Act).
    \607\ Proposed Sec.  92.4.
---------------------------------------------------------------------------

    In the Department's view, Medicare Part B payments constitute 
Federal financial assistance and providers subsidized as a result of 
those payments are recipients. The Department's long-held view that 
Medicare Part A constitutes Federal financial assistance is 
instructive.\608\ Like Medicare Part A, Medicare Part B is a Department 
program that provides payment for health services to eligible 
individuals.\609\ Eligible individuals choose to enroll in Medicare 
Part B and pay a monthly fee for coverage; in exchange, the program 
covers the services provided by medical providers and suppliers \610\ 
for the services and supplies they provide to these individuals. In 
addition to fee payments made by beneficiaries, Federal funds are used 
to subsidize the entities that provide Part B services. The Federal 
funding benefits Part B beneficiaries by assisting them in paying for 
necessary health care services; and providers, in turn, receive the 
benefit of a reliable source of payment for the services provided to 
eligible patients, at least some of whom may have been unable to afford 
services otherwise. As in Grove City College v. Bell, discussed below, 
the government is assisting providers of services by making available 
to them a segment of the patient population that either (a) would not 
have been able to afford any medical services, or (b) would not have 
been able to afford these specific providers. In these respects, Part B 
is no different than Part A because Part B is financial assistance to 
providers that subsidizes their provision of health care to Part B 
beneficiaries. Further, providers are recipients of these funds because 
they are entities that operate health programs and activities to whom 
Federal financial assistance is provided.
---------------------------------------------------------------------------

    \608\ 45 CFR pt. 80 app. A pt. I, No. 121 (Federal Assistance to 
which these Regulations Apply; Assistance other than continuing 
assistance to States; Supplementary medical insurance benefits for 
the aged (Title XVIII, Part A, Social Security Act, 42 U.S.C. 1395c-
1395i-2)).
    \609\ Medicare Part A also pays for hospital coverage and care 
in skilled nursing facilities. Parts of Medicare, Medicare.gov, 
https://www.medicare.gov/basics/get-started-with-medicare/medicare-basics/parts-of-medicare (last visited June 15, 2022). Medicare Part 
B provides coverage for outpatient care by physicians and other 
health care providers, lab tests, home health care, durable medical 
equipment, and many preventive services. Id. See also What Medicare 
Covers, Medicare.gov, https://www.medicare.gov/what-medicare-covers 
(last visited June 15, 2022).
    \610\ We use the term ``providers'' to refer to physician's 
offices and other entities that provide Part B services, consistent 
with the use of the term ``provider'' elsewhere in this rule. We 
acknowledge that this term has a different meaning in the Medicare 
program.
---------------------------------------------------------------------------

    Despite these clear similarities, the Department has previously 
considered Medicare Part A to constitute Federal financial assistance, 
while analyzing Part B differently. When the Department's Title VI 
regulation was first published, the Department included an Appendix, 
titled Federal Assistance to Which These Regulation Apply.\611\ 
Although the Appendix is to the Department's Title VI regulation, the 
Department and courts have relied on it in determining whether 
Department funds are Federal financial assistance in claims under Title 
IX, Section 504, and the Age Act, as well.\612\ The Appendix contains 
two lists: ``Assistance Other than Continuing Assistance to States,'' 
and ``Continuing Assistance to States.'' In the former list, the 
Department included Medicare Part A, but not Medicare Part B.\613\ The 
omission reflected the Department's position that Medicare Part B did 
not constitute Federal financial assistance.\614\ Many courts have held 
that Medicare Part A is Federal financial assistance for the purpose of 
coverage under the Spending Clause civil rights statutes.\615\
---------------------------------------------------------------------------

    \611\ 45 CFR pt. 80 app. A, pt. I, No. 121.
    \612\ See, e.g., Chowdury v. Reading Hosp. & Med. Ctr., 677 F.2d 
317, 318-19 (3d Cir. 1982), cert. denied, 463 U.S. 1229 (1983) 
(Title VI); Doe v. League Sch. of Greater Boston, Inc., No. 16-cv-
1194, 2017 WL 3594257, at *4 (D. Mass. Aug. 21, 2017) (Title IX).
    \613\ 45 CFR pt. 80 app. A., pt. I, No. 121.
    \614\ See 81 FR 31375, 31383 (May 18, 2016) (proposing that, 
``consistent with OCR's enforcement of other civil rights 
authorities, the definition of Federal financial assistance does not 
include Medicare Part B'' under Section 1557). The Department 
provided the following explanation in its Section 504 final rule: 
``In its May 1976 Notice of Intent, the Department suggested that 
the arrangement under which individual practitioners, hospitals, and 
other facilities receive reimbursement for providing services to 
beneficiaries under Part B of title XVIII of the Social Security Act 
(Medicare) constitutes a contract of insurance or guaranty and thus 
falls within the exemption from the regulation. This explanation 
oversimplified the Department's view of whether Medicare Part B 
constitutes Federal financial assistance. The Department's position 
has consistently been that, whether or not Medicare Part B 
arrangements involve a contract of insurance or guaranty, no Federal 
financial assistance flows from the Department to the doctor or 
other practitioner under the program, since Medicare Part B--like 
other social security programs--is basically a program of payments 
to direct beneficiaries.'' 45 CFR pt. 84 app. A (Analysis of Final 
Regulation); 42 FR 22676, 22685 (May 4, 1977).
    \615\ See, e.g., U.S. v. Baylor Univ. Med. Ctr., 736 F.2d 1039, 
1042 (5th Cir. 1984), cert. denied, 469 U.S. 1189 (1985); Bernard B. 
v. Blue Cross & Blue Shield, 528 F. Supp. 125, 132 (S.D.N.Y. 1981), 
aff'd, 679 F.2d 7 (2d Cir. 1982); Bob Jones Univ. v. Johnson, 396 F. 
Supp. 597, 603 n. 21 (D.S.C. 1974), aff'd, 529 F.2d 514 (4th 
Cir.1975); Austin v Blue Cross Blue Shield of Ala., No. 4:09-cv-
1647, 2009 WL 10703738, at *1, n.1 (N.D. Ala. Oct. 16, 2009); Waris 
v. HCR Manor Care, No. 07-cv-3344, 2009 WL 330990, at *19 (E.D. Pa. 
Feb. 10, 2009), aff'd, on other gr., 365 Fed. App'x. 402 (3d Cir. 
2021); Campen v. Portland Adventist Med. Ctr., No. 3:16-cv-00792; 
2016 WL 5853736, at * 4 (D. Or. Sept. 2, 2016), adopted by 2016 WL 
5858670 (D. Or. Oct. 5, 2016); Zamora-Quezada v. HealthTexas Med. 
Group. of San Antonio, 34 F. Supp. 2d 433, 440 (W.D. Tex. 1998); 
People by Vacco v. Mid Hudson Med. Group, P.C., 877 F. Supp. 143, 
149-40 (S.D.N.Y. 1995); Glanz v Vernick, 756 F. Supp. 632, 636 (D. 
Mass. 1991); Doe v. Centinela Hosp., No. 87-cv-2514 PAR, 1988 WL 
81776 (C.D. Cal. June 30, 1988); Bhatt v. Uniontown Hosp., No. 83-
2455, 1986 WL 30681, at *4 (W.D. Pa. Mar. 20, 1986); U.S. v. Univ. 
Hosp. of the State Univ. of N.Y. at Stony Brook, 575 F. Supp. 607, 
612 (E.D.N.Y. 1983), aff'd on other gr., 729 F.2d 144 (2d Cir. 
1984); U.S. v Cabrini Med. Ctr., 497 F. Supp. 95, 96 n. 1 (S.D.N.Y. 
1980), rev'd on other gr., 639 F.2d 908, 910-11 (2d Cir. 1981); 
NAACP v. Wilmington Med. Ctr., Inc., 453 F. Supp. 280, 329 (D. Del. 
1978), Flora v. Moore, 461 F. Supp. 1104, 1115 (N.D. Miss. 1978). 
Because many hospitals receive funds under Medicare and Medicaid, 
many of these cases address both types of funding together. Some of 
these cases refer specifically to Part A of Medicare in holding that 
the funds are Federal financial assistance; others refer to Medicare 
but given that the defendant is a hospital or other facility that 
Part A funding covers, the funds at issue have been Part A funds.
---------------------------------------------------------------------------

    In explaining its position that Medicare Part B was not Federal 
financial assistance in proposing the regulations implementing Section 
504, the Department relied on the fact that Medicare Part B is 
``provided by way of a contract,'' and thus is a contract of

[[Page 47889]]

insurance or guaranty that falls within the exception to ``Federal 
financial assistance'' in Title VI.\616\ In 1977, the Department 
subsequently clarified, however, that this ``explanation oversimplified 
the Department's view of whether Medicare Part B constitutes Federal 
financial assistance.'' \617\ In adopting this position in its final 
rule implementing Section 504, the Department explained that ``its 
position has consistently been that, whether or not Medicare Part B 
arrangements involve a contract of insurance or guaranty, no Federal 
financial assistance flows from the Department to the doctor or other 
practitioner under the program, since Medicare Part B--like other 
social security programs--is basically a program of payments to direct 
beneficiaries.'' \618\ Given this clarification, we will focus 
primarily here on the Department's 1977 rationale that no Federal 
financial assistance flows from the Department to a provider under the 
program.
---------------------------------------------------------------------------

    \616\ 41 FR 20296, 20298 (May 17, 1976) (discussing 42 U.S.C. 
2000d-1, d-4).
    \617\ 42 FR 22685.
    \618\ Id.; 41 FR 20298.
---------------------------------------------------------------------------

    The Department's 1977 rationale regarding the payment to 
beneficiaries no longer reflects how Medicare Part B operates. When the 
Medicare Part B program was first enacted in 1965, program 
beneficiaries generally paid for services out of pocket and received 
partial reimbursement from the program. That is no longer the most 
common method by which providers receive funds. The Medicare and 
Medicaid Act (the ``Medicare Act'') currently allows physicians and 
many other Part B providers and suppliers to ``accept assignment'' for 
Medicare Part B claims.\619\ Providers thereby accept Medicare's 
approved amount for a service and can only charge a beneficiary co-
insurance and a deductible.\620\ Providers bill the Medicare program 
directly for services they provide to Part B program beneficiaries and 
are paid directly by the Department.\621\
---------------------------------------------------------------------------

    \619\ 42 U.S.C. 1395u(h)-(i).
    \620\ Lower Costs with Assignment, Medicare.gov, https://www.medicare.gov/your-medicare-costs/part-a-costs/lower-costs-with-assignment (last visited June 15, 2022).
    \621\ Id.
---------------------------------------------------------------------------

    Significantly, at the present time, approximately two-thirds of 
providers enrolled in the Medicare Part B program are ``participating 
providers,'' \622\ i.e., providers that bill and are paid by the 
Medicare program. Thus, the Department's primary historical rationale 
for its position that Medicare Part B was not Federal financial 
assistance does not reflect the current operation of the program for 
the majority of providers participating in the program. Those providers 
have become direct recipients of Federal financial assistance. This 
significant change in facts provides ample support for the Department's 
change of interpretation as applied to those providers.\623\
---------------------------------------------------------------------------

    \622\ Medicare Provider Enrollment Chain and Ownership System 
(PECOS), https://pecos.cms.hhs.gov/pecos/login.do#headingLv1 (last 
visited June 15, 2022).
    \623\ See Nat'l Cable & Telecomms. Ass'n v. Brand X internet 
Servs., 545 U.S. 967, 981 (2005) (``[a]n initial agency 
interpretation is not instantly carved in stone. On the contrary, 
the agency . . . must consider varying interpretations and the 
wisdom of its policy on a continuing basis, for example, in response 
to changed factual circumstances . . .'').
---------------------------------------------------------------------------

    Providers commonly known as ``non-participating providers'' also 
provide services to Medicare beneficiaries, but they do not agree to 
accept Medicare's approved amount as full payment, and can charge up to 
15 percent more than Medicare's approved amount.\624\ They also receive 
a lower payment rate through the program.\625\ Non-participating 
providers must enroll in the Part B program for their services to be 
covered by the program, but do not receive direct payment from the Part 
B program.\626\ Thus, whereas they are referred to as ``non-
participating'' because they do not receive direct Medicare assignment 
and are not subject to the usual participating provider fee limitations 
like participating providers, non-participating providers do 
participate in the Part B program overall, and enroll in the program so 
that the services they provide to Part B beneficiaries will be 
subsidized by the program. (In contrast, providers referred to as 
``opt-out providers'' opt out of Medicare Part B entirely, and Medicare 
does not pay for the services these providers provide to Part B 
beneficiaries, either directly to providers themselves, or by 
reimbursing Part B beneficiaries after the fact for these services.) 
\627\
---------------------------------------------------------------------------

    \624\ 42 U.S.C. 1395w-4(g)(1); Lower Costs with Assignment, 
supra note 620.
    \625\ Lower Costs with Assignment, supra note 620.
    \626\ 42 CFR 424.510.
    \627\ Lower Costs with Assignment, supra note 620.
---------------------------------------------------------------------------

    Given this relationship of non-participating providers to the 
Medicare Part B program, the Department believes that non-participating 
providers are also recipients of Federal financial assistance under the 
principles set forth by the Supreme Court in Grove City College v. 
Bell, where the Court held that Federal assistance loans provided to 
students to cover education-related expenses is Federal financial 
assistance to educational institutions under Title IX.\628\ The Court 
explained that ``[n]othing . . . [ ] suggests that Congress elevated 
form over substance by making the application of the nondiscrimination 
principle dependent on the manner in which a program or activity 
receives Federal assistance. There is no basis in the statute for the 
view that only institutions that themselves apply for Federal aid or 
receive checks directly from the Federal Government are subject to 
regulation.'' \629\
---------------------------------------------------------------------------

    \628\ Grove City Coll. v. Bell, 465 U.S. 555, 565 (1984).
    \629\ Id. at 564.
---------------------------------------------------------------------------

    Critically, the Court noted that the Federal financial assistance 
in question ``was structured to ensure that it effectively supplements 
the College's own financial aid program.'' \630\ In doing so, it 
rejected the argument that student loans were akin to general 
assistance programs such as ``food stamps, Social Security benefits, 
welfare payments, and other forms of general-purpose governmental 
assistance to low-income families.'' \631\ Among the reasons the Court 
cited for this rejection were the fact that ``general assistance 
programs, unlike student aid programs, were not designed to assist 
colleges and universities'' and that ``educational institutions have no 
control over, and indeed perhaps no knowledge of, whether they 
ultimately receive Federal funds made available to individuals under 
general assistance programs [like Social Security], but they remain 
free to opt out of Federal student assistance programs.'' \632\ 
Entities such as non-participating providers are aware of the flow of 
Federal financial assistance to them and are permitted to opt out.
---------------------------------------------------------------------------

    \630\ Id. at 565.
    \631\ Id. at n.13
    \632\ Id.
---------------------------------------------------------------------------

    In the Department's view, the rationale set forth in Grove City 
College counsels in favor of considering non-participating providers 
under Medicare Part B to be indirect recipients of Federal financial 
assistance. Part B funds, like the Federal student aid provided to 
students at issue in Grove City College, are ``designed'' to 
effectively subsidize health care providers and suppliers for the 
health services and supplies they provide to program beneficiaries. 
Program beneficiaries who see a non-participating provider receive a 
Part B payment from the program for one reason only: they have received 
health services or supplies from a provider that has enrolled in the 
Part B program and paid for the service out of pocket. The amount that 
the provider may charge is controlled by the terms of the provider's

[[Page 47890]]

enrollment agreement in Medicare Part B. Accordingly, even though a 
non-participating provider does not accept assignment, it remains a 
willing participant in the Medicare Part B program and it agrees to 
treat patients receiving Medicare Part B with the awareness that its 
services that will be subsidized by the Department. In contrast to 
general assistance programs, and similar to the student aid program at 
issue in Grove City College, non-participating providers thus have 
knowledge and control of whether they receive Federal funds and their 
participation status, and remain free to opt out.\633\ Further, Title 
VI, Section 504, Title IX, the Age Act, and this proposed rule all 
require entities to sign an assurance of compliance with these laws as 
a condition of receiving Federal funds.\634\ Thus both participating 
and non-participating providers will have a choice as to whether to 
accept the funds and comply with these civil rights laws or decline the 
funds.
---------------------------------------------------------------------------

    \633\ Id.
    \634\ 45 CFR 80.4 (Title VI); Sec.  84.5 (Section 504); Sec.  
86.4 (Title IX); Sec.  91.33 (Age Act); proposed Sec.  92.5.
---------------------------------------------------------------------------

    Accordingly, the Department's principal 1977 rationale regarding 
the flow of Federal assistance can no longer justify excluding Medicare 
Part B payments from the definition of Federal financial assistance. 
Participating providers are the direct recipients of Federal financial 
assistance; and non-participating providers are the indirect recipients 
of such assistance.
    A second rationale that the Department has mentioned as potential 
support for its past position that Medicare Part B is not Federal 
financial assistance is that Medicare Part B is a ``contract of 
insurance or guaranty.'' \635\ The Title VI statute \636\ and 
regulations, and Section 504, Title IX, and Age Act regulations \637\ 
exclude a contract of insurance from the definition of ``Federal 
financial assistance.'' Significantly, after initially relying on this 
rationale, the Department clarified that its position did not depend on 
this rationale.\638\ Moreover, this prior rationale does not provide a 
strong basis for interpreting Medicare Part B as something other than 
Federal financial assistance.
---------------------------------------------------------------------------

    \635\ 41 FR 20296, 20298 (May 17, 1976).
    \636\ 42 U.S.C. 2000d et seq. The legislative history of Title 
VI indicates that the ``contract of insurance or guaranty'' 
exclusion was added to the bills that became Title VI to address the 
concern of some members of Congress that without the exclusion, 
federally insured banks providing housing mortgages would be covered 
by Title VI and be prohibited from denying mortgages based on ``the 
choice of a neighbor,'' i.e., engaging in redlining, a practice now 
prohibited by the Federal Fair Housing Act. 110 Cong. Rec. 1345-6 
(Statement of Sen. Pastore); 110 Cong. Rec. 1497-1500 (colloquy 
between Rep. Cramer, and Willard W. Wirtz, Secretary of Labor); 110 
Cong. Rec. 1519 (Statement of Rep. Heller); 110 Cong. Rec. 13377-78 
(June 10, 1964) (Statement of Sen. Long),110 Cong. Rec. 13435 (June 
10, 1964) (Statement of Sen. Humphrey). 110 Cong. Rec. 13454-6 
(Statement of Sen. Pastore); 110 Cong. Rec. 13435 (June 10, 1964) 
(Statement of Sen. Humphrey). When Medicare was being enacted, some 
indications in the legislative history suggest that Congress assumed 
that Title VI would apply to it. See, e.g., 111 Cong. Rec. 15813 
(July 7, 1965) (Statement of Sen. Hart).
    \637\ 45 CFR 80.13(f) (Title VI); Sec.  84.3(h) (Section 504); 
Sec.  86.2(g) (Title IX); Sec.  91.4 (Age Act).
    \638\ 42 FR 22685.
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    First, with respect to Section 1557 in particular, Congress made 
clear in the text of the statute that a ``contract of insurance'' can 
constitute Federal financial assistance, expressly declining to include 
the exception from Title VI.\639\ Thus, whatever the meaning of that 
exception might be in Title VI, and in the Title IX, Section 504, and 
Age Act regulations, it does not apply to Section 1557.
---------------------------------------------------------------------------

    \639\ 42 U.S.C. 18116(a).
---------------------------------------------------------------------------

    Second, the Department now is of the view that Medicare Part B 
funding is not covered by that Title VI exception, because it is not a 
``contract of insurance or guaranty.'' It is instructive, in this 
regard, to consider how the Department has analyzed Medicare Part A 
with respect to the question of what constitutes Federal financial 
assistance. Medicare Part A and Part B are fundamentally similar in 
many respects. Both are Federal programs providing health-related 
coverage to eligible individuals. In both, providers agree to meet 
conditions of participation or coverage in exchange for receiving 
payments for their services to eligible enrolled individuals. In both, 
payments come from a Federal trust fund. In both, the services covered, 
fees paid, and other aspects of the program are governed by a variety 
of statutes and regulations. That participation in Part B is voluntary 
for eligible individuals does not make Part B funds a ``contract of 
insurance or guaranty,'' particularly since some individuals who do not 
qualify for ``premium-free'' Part A coverage can ``buy-in'' to Medicare 
Part A.\640\ Part A buy-in has been a feature of Medicare since 1972, 
though the statute has subsequently been amended to expand eligibility 
for this option.\641\ Both Parts contain the word ``insurance'' in 
their Titles; \642\ yet Medicare Part A has always been considered 
Federal financial assistance by the Department, notwithstanding this 
denomination. Thus, the use of this term in Part B has no more 
significance than it does in Part A. In both programs, insurance 
companies serve as Medicare Administrative Contractors, processing 
claims and paying providers \643\ as agents of the Department, not as 
insurers of individuals. We note as well that most of the funding for 
the Part B fund comes from Federal and State tax revenue and interest 
on investments, not ``premium'' payments.\644\
---------------------------------------------------------------------------

    \640\ Part A Costs, Medicare.gov, https://www.medicare.gov/your-medicare-costs/part-a-costs (last visited June 15, 2022).
    \641\ Public Law 92-603, 202, 86 Stat. 1329 (Oct. 30, 1972), as 
amended by, The Omnibus Budget Reconciliation Act of 1989, Public 
Law 101-239, 6013, 103 Stat. 2106 (Dec. 19, 1989).
    \642\ 42 U.S.C. ch. 7, subch. XVIII, pt. A (Hospital Insurance 
Benefits for Aged and Disabled); 42 U.S.C. ch. 7, subch. XVIII, pt. 
B (Supplementary Insurance Benefits for Aged and Disabled).
    \643\ 42 U.S.C. 1395kk-1; Medicare Administrative Contractors, 
Ctrs. for Medicare & Medicaid Servs., https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/MedicareAdministrativeContractors (last visited June 15, 2022).
    \644\ Tax Policy Ctr., Tax Policy Center Briefing Book: Key 
Elements of the U.S. Tax System, https://www.taxpolicycenter.org/briefing-book/what-medicare-trust-fund-and-how-it-financed (last 
visited June 15, 2022) (indicating SMI trust fund received over 70% 
of its 2017 year assets from general revenue, including individual 
income taxes, corporate taxes, and excise taxes).
---------------------------------------------------------------------------

    The Department seeks comment on the impact that this proposed 
change may have on recipients subsidized only by Medicare Part B funds 
and no other sources of Federal financial assistance from the 
Department. We also seek comment on the time that should be allowed for 
recipients of Part B funds to come into compliance with the applicable 
statutes and their implementing regulations and what resources the 
Department can provide to assist newly covered entities in coming into 
compliance.

V. CMS Amendments

    The 2020 Rule amended ten provisions in CMS regulations, at least 
some of which cover entities that are also subject to Section 1557, to 
delete language that prohibited discrimination on the basis of sexual 
orientation and gender identity.\645\ These provisions included 
regulations governing

[[Page 47891]]

Medicaid and CHIP; \646\ PACE; \647\ health insurance issuers including 
issuers providing essential health benefits (EHB) and issuers of 
qualified health plans (QHPs), and their officials, employees, agents, 
and representatives; States and the Exchanges carrying out Exchange 
requirements; and agents, brokers, or web-brokers that assist with or 
facilitate enrollment of qualified individuals, qualified employers, or 
qualified employees.\648\ The 2020 Rule stated that in light of the 
overarching applicability of Section 1557 to these programs and 
entities, the Department was making these amendments to ensure greater 
consistency in civil rights enforcement across the Department's 
different programs.\649\ See supra section II.B. for additional detail.
---------------------------------------------------------------------------

    \645\ See 85 FR 37160, 37162 (June 19, 2020) (the provisions 
that were amended included: Medicaid and CHIP (42 CFR 438.3(d)(4), 
Sec.  438.206(c)(2), Sec.  440.262); PACE (42 CFR 460.98(b)(3), 
Sec.  460.112(a)); issuers offering coverage in the group and 
individual markets (45 CFR 147.104(e)); Exchange-related programs 
(45 CFR 155.120(c)(1)(ii), Sec.  155.220(j)(2)(i), Sec.  156.200(e), 
Sec.  156.1230(b)(2)). 45 CFR 147.104 applies not only to issuers 
subject to Section 1557, but to all health insurance issuers 
offering non-grandfathered individual, small group, and large group 
health insurance, and Sec.  156.125(b) applies not only to issuers 
subject to Section 1557, but to all health insurance issuers 
offering non-grandfathered individual and small group health 
insurance.
    \646\ The 2020 Rule, at 85 FR 37221, removed references to 
sexual orientation and gender identity as a prohibited basis of 
discrimination from 42 CFR 438.3(d)(4), Sec.  438.206(c)(2), and 
Sec.  440.262.
    \647\ The 2020 Rule, at 85 FR 37220-21, removed references to 
sexual orientation from 42 CFR 460.98(b)(3) and Sec.  460.112(a). 
However due to a publishing error, the text of Sec.  460.112(a) 
still states that PACE participants have the right not to be 
discriminated against on the basis of sexual orientation.
    \648\ The 2020 Rule, at 85 FR 37221, removed references to 
sexual orientation and gender identity as a prohibited basis of 
discrimination from 45 CFR 147.104(e), Sec.  155.120(c)(1)(ii), 
Sec.  155.220(j)(2)(i), Sec.  156.200(e), and Sec.  156.1230(b)(2).
    \649\ 85 FR 37162.
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    The Department is committed to ensuring that all persons should be 
able to access health care without being subjected to sex 
discrimination, and that all persons should receive equal treatment 
under the law, no matter their gender identity or sexual orientation. 
Accordingly, in this proposed rule, the Department proposes to amend 
these CMS regulations \650\ so that they again identify and recognize 
discrimination on the basis of sexual orientation and gender identity 
as prohibited forms of discrimination based on sex. In addition, the 
Department proposes to amend a regulation applying these protections in 
CHIP to also apply to Medicaid fee-for-service programs and managed 
care programs. These proposals are consistent with those elsewhere in 
this proposed rule and would ensure that sexual orientation and gender 
identity are added and promote consistency across HHS programs of 
policies and requirements that prohibit discrimination based on sexual 
orientation or gender identity. In the ``Patient Protection and 
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 
2023'' published in the Federal Register on January 5, 2022 (2023 
Payment Notice proposed rule),\651\ HHS proposed similar amendments to 
some of those same regulations applicable to Exchanges, QHPs, and 
certain issuers to prohibit discrimination based on sexual orientation 
and gender identity.\652\ These provisions were not finalized in the 
Final Rule published on May 6, 2022.\653\ Commenters that provided 
comments on the 2023 Payment Notice proposed rule should not submit 
duplicative comments to this proposed rule as the Department will 
consider all comments previously submitted regarding these proposals in 
issuing its final rule.
---------------------------------------------------------------------------

    \650\ See 85 FR 37162 (the provisions that were amended 
included: Medicaid and CHIP (42 CFR 438.3(d)(4), Sec.  
438.206(c)(2), Sec.  440.262); PACE (42 CFR 460.98(b)(3), Sec.  
460.112(a)); issuers offering coverage in the group and individual 
markets (45 CFR 147.104(e)); Exchange-related programs (45 CFR 
155.120(c)(1)(ii), Sec.  155.220(j)(2)(i), Sec.  156.200(e), Sec.  
156.1230(b)(2)).
    \651\ 87 FR 584 (Jan. 5, 2022).
    \652\ 45 CFR 147.104(e); Sec.  155.120(c)(1)(ii); Sec.  
155.220(j)(2)(i); Sec.  156.200(e); Sec.  156.1230(b)(2).
    \653\ 87 FR 27208, 27209 (May 6, 2022).
---------------------------------------------------------------------------

    Prohibiting sex discrimination based on sexual orientation and 
gender identity can lead to improved health outcomes for members of the 
LGBTQI+ community. Without such protection, individuals will likely 
continue facing barriers to accessing medically necessary health care. 
For example, without protection from discrimination, transgender 
individuals may face barriers or be denied clinically appropriate 
gender-affirming care.
    On June 15, 2020, the U.S. Supreme Court held that Title VII's 
prohibition on employment discrimination based on sex encompasses 
discrimination based on sexual orientation and gender identity.\654\ 
The Bostock majority concluded that the plain meaning of ``because of 
sex'' in Title VII necessarily included discrimination because of 
sexual orientation and gender identity.\655\ Subsequently, DOJ's Civil 
Rights Division issued a memorandum \656\ concluding that the Supreme 
Court's reasoning in Bostock applies to Title IX. As made clear by the 
ACA, Section 1557 prohibits discrimination ``on the ground prohibited 
under . . . Title IX.'' \657\
---------------------------------------------------------------------------

    \654\ Bostock v. Clayton Cnty., 140 S. Ct. 1731 (2020).
    \655\ Id. at 1753-54.
    \656\ Karlan Memo, supra note 46.
    \657\ 42 U.S.C. 18116(a).
---------------------------------------------------------------------------

    Consistent with Bostock, HHS OCR issued its Bostock Notification, 
interpreting Section 1557's prohibition on discrimination on the basis 
of sex to include discrimination on the basis of sexual orientation and 
gender identity. Based on this and the statutory authorities identified 
below, the Department also relies on Section 1557 as authority for the 
proposed amendments to 45 CFR 155.120, 155.220, 156.200, and 156.1230 
as well as 42 CFR 438.3(d)(4), 42 CFR 438.206(c)(2), and 42 CFR 440.262 
in this proposed rule. CMS is also proposing a parallel amendment to 45 
CFR 147.104 that would prohibit discrimination on the basis of sex 
(including on the basis of sexual orientation or gender identity) 
consistent with the Section 1557 implementing regulations proposed in 
this rule but is relying on the separate authorities identified later 
in this discussion. We are also including a discussion at 45 CFR 
156.125 that clarifies how the proposed change to 45 CFR 156.200 would 
impact the nondiscrimination requirements for plans providing EHB such 
that plans subject to EHB requirements would be prohibited from 
discriminating on the basis of sex (including sexual orientation or 
gender identity) relying on separate authorities identified below. 
Subpart B of this NPRM discusses the Section 1557's prohibition on 
discrimination on the basis of sex (including pregnancy, sex 
characteristics, sexual orientation, and gender identity). This portion 
of the preamble focuses on the CMS freestanding, independent provisions 
that have long provided for nondiscrimination on the basis of sex in 
its programs and services. While the Section 1557 NPRM proposes to 
include sex stereotypes, sex characteristics, pregnancy or related 
conditions, sexual orientation, and gender identity as enumerated forms 
of sex discrimination, CMS limits the explicit mention to gender 
identity and sexual orientation, while understanding that 
discrimination on the basis of sex stereotypes, sex characteristics, 
and pregnancy or related conditions is prohibited sex discrimination. 
We seek comment on this approach for all of the CMS provisions 
addressed in this section.

A. Medicaid and Children's Health Insurance Program (CHIP)

    In the Medicaid and CHIP managed care final rule published in the 
Federal Register on May 6, 2016,\658\ CMS explicitly included 
prohibitions on discrimination based on sexual orientation or gender 
identity. In that rulemaking, CMS explained that adopting protections 
against discrimination on these bases was necessary to assure that care 
and services are provided in a manner consistent with the best interest 
of beneficiaries under section 1902(a)(19)

[[Page 47892]]

of the Social Security Act (``the SSA'') and relied on authority under 
section 1902(a)(4) of the SSA to adopt regulatory antidiscrimination 
protections and obligations for managed care plans.\659\ We amended 42 
CFR 438.3(d)(4), which prohibits enrollment discrimination in contracts 
with managed care organizations, prepaid inpatient health plans, 
prepaid ambulatory health plans, primary care case managers, and 
primary care case management entities, as well as 42 CFR 438.206(c)(2), 
which, as amended, required each managed care organization, prepaid 
inpatient health plan, and prepaid ambulatory health plan to 
participate in a ``State's efforts to promote the delivery of services 
in a culturally competent manner to all enrollees, . . . regardless of 
gender, sexual orientation or gender identity.'' We also explained that 
the obligation for the state plan to promote access and delivery of 
services without discrimination was necessary to assure that care and 
services were provided in a manner consistent with the best interest of 
beneficiaries under section 1902(a)(19) of the SSA.\660\ Therefore, in 
the Medicaid and CHIP managed care 2016 final rule, we created a new 
provision entitled ``Access and cultural considerations'' at 42 CFR 
440.262, requiring states to 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 gender, sexual orientation or gender identity.'' In addition, 42 CFR 
438.3(f) (which is also applicable to CHIP managed care entities per 
Sec.  457.1201(f)), requires compliance with all applicable Federal and 
State laws and regulations, including Section 1557. The 
antidiscrimination provision in Sec.  438.3(d)(4) also applied to CHIP 
managed care entities under Sec.  457.1201(d); those CHIP managed care 
regulations apply the terms of the Medicaid managed care regulations 
through existing cross-references. As explained in the Medicaid and 
CHIP managed care 2016 final rule, CMS believes it is appropriate to 
align the requirements for managed care programs in the Medicaid and 
CHIP contexts, including with regard to beneficiary protections and 
access to services.\661\
---------------------------------------------------------------------------

    \658\ 81 FR 27498 (May 6, 2016).
    \659\ 80 FR 31097, 31147-48 (June 1, 2015); 81 FR 27538-39, 
27666.
    \660\ 81 FR 27666.
    \661\ 80 FR 31169-71, 31173; 81 FR 27757-58, 27765.
---------------------------------------------------------------------------

    Due to an oversight, the Medicaid and CHIP managed care 2016 final 
rule did not apply the provisions requiring nondiscrimination as 
described in 42 CFR 440.262 to fee-for-service CHIP programs. In the 
Department's view, providing access to services in a non-discriminatory 
manner is in the best interest of all CHIP beneficiaries. CMS therefore 
now proposes to rectify that omission by incorporating 42 CFR 440.262 
into CHIP regulations through a cross-reference at 42 CFR 457.495(e). 
Taken together, these protections further the purpose of CHIP to 
provide child health assistance in an effective and efficient manner 
that is consistent with section 2101(a) of the SSA.
    CMS now proposes, based on Section 1557 as discussed previously, 
and its separate statutory authority under sections 1902(a)(4) of the 
SSA (codified at 42 U.S.C. 1396a(a)(4)) and 2101(a) of the SSA 
(codified at 42 U.S.C. 1397aa(a)), to amend 42 CFR 438.3(d)(4), 42 CFR 
438.206(c)(2), and 42 CFR 440.262 to again prohibit Medicaid and CHIP 
managed care organizations, prepaid inpatient health plans, prepaid 
ambulatory health plans, primary care case managers, and primary care 
case management entities in managed care programs from discriminating 
on the basis of sexual orientation and gender identity, and to require 
managed care plans and State fee-for-service Medicaid and CHIP programs 
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 gender, sexual orientation or gender identity. As noted 
above, the managed care contracting and service delivery provisions 
would also apply to CHIP managed care entities based on existing 
regulations, creating an alignment in the Medicaid and CHIP managed 
care requirements.
    As HHS noted in its 2016 Medicaid CHIP managed care final 
rule,\662\ CMS possesses statutory authority to amend 42 CFR 
438.3(d)(4), 42 CFR 438.206(c)(2), and 42 CFR 440.262 under section 
1902(a)(4) of the SSA, which authorizes the Secretary to adopt methods 
of administration necessary for the proper and efficient operation of 
the Medicaid state plan; section 1902(a)(19) of the SSA (codified at 42 
U.S.C. 1396a(a)(19)), which requires the Medicaid state plan to provide 
safeguards as necessary to assure that covered services are provided in 
a manner consistent with the best interests of the recipients; and 
section 2101(a) of the SSA (codified at 42 U.S.C. 1397aa(a)), which 
permits provision of funds to States to enable them to initiate and 
expand the provision of child health assistance to uninsured, low-
income children in an effective and efficient manner. CMS interprets 
section 1902(a)(19) of the SSA as prohibiting discrimination in the 
delivery of services because such discrimination is inconsistent with 
the best interests of the Medicaid beneficiaries who are eligible for 
and receive services. CMS interprets sections 1902(a)(4) and 2101(a) of 
the SSA as authorizing CMS to adopt regulations prohibiting 
discrimination on the basis of gender identity or sexual orientation 
because such prohibitions on discrimination are necessary for the 
proper and efficient operation of a state plan, are in the best 
interest of beneficiaries, and enable states to provide child health 
assistance in an effective and efficient manner. Adopting regulations 
to ensure that eligible beneficiaries receive services under these 
programs is consistent with the purpose of the Medicaid and CHIP 
programs to furnish and expand access to medical assistance. The 
proposed amendments to 42 CFR 438.3(d)(4), 438.206(c)(2), 440.262, and 
457.495(e) would explicitly prohibit discrimination on the basis of 
sexual orientation and gender identity in addition to the existing 
prohibitions imposed on Medicaid and CHIP under Section 1557. 
Importantly, adopting a broader interpretation of what is necessary and 
appropriate to ensure proper and efficient Medicaid and CHIP programs 
and to ensure services are delivered in a manner that is in the best 
interest of the beneficiary is warranted in light of the existing 
trends in health care discrimination \663\ and to better address 
barriers to health equity. Section II.D. of this NPRM includes an 
extensive discussion of LGBTQI+ health disparities. These CMS 
conforming amendments, in addition to the broad prohibition on 
discrimination required under Section 1557, allow CMS to ensure that 
its programs and services are operated without discrimination and would 
help address those disparities. While we are restoring 42 CFR 
438.3(d)(4), 438.206(c)(2), 440.262, and adding 457.495(e), as part of 
using our longstanding program authority, Section 1557 requires 
nondiscrimination in these programs and services.
---------------------------------------------------------------------------

    \662\ 81 FR 27498.
    \663\ Thu T. Nguyen et al., Trends for Reported Discrimination 
in Health Care in a National Sample of Older Adults with Chronic 
Conditions, 33 J. Gen. Intern. Med. 291 (2018), https://doi.org/10.1007/s11606-017-4209-5.

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[[Page 47893]]

    Section 1557 prohibits discrimination on the basis of sex, 
importantly including sexual orientation and gender identity. CMS is 
proposing to amend 42 CFR 440.262 to restore the explicit prohibition 
against discrimination in the delivery of services on the basis of 
sexual orientation and gender identity. We also propose to replace 
``gender'' with ``sex'' and add ``(including sexual orientation and 
gender identity)'' for consistency with the proposals elsewhere in this 
proposed rule, to ensure that sexual orientation and gender identity 
are added, and to promote consistency across HHS programs. As adopted 
in 2016, the regulation at 42 CFR 440.262 was described by CMS as an 
obligation for the state Medicaid plan to promote access and delivery 
of services without discrimination \664\ and the proposal here 
reiterates the meaning and scope for this regulation. By reinstating 
the explicit references to sexual orientation and gender identity as 
forms of sex discrimination, this proposal would amend 42 CFR 440.262 
to protect individuals from discrimination on those bases in the same 
way that discrimination on the basis of limited English proficiency, 
disabilities, and cultural and ethnic backgrounds is prohibited. We 
also propose to change ``unique needs'' in 42 CFR 440.262 to 
``individualized needs'' to more accurately reflect Medicaid's goal of 
providing person-centered care. As adopted in 2016, the regulation at 
42 CFR 438.206(c)(2) required Medicaid managed care plans to 
participate in the State efforts to promote the delivery of services in 
a manner required by 42 CFR 440.262,\665\ so CMS is proposing to amend 
42 CFR 438.206(c)(2) to reinstate the references to sexual orientation 
and gender identity to align the Medicaid managed care regulation with 
the proposal to amend 42 C.F.R 440.262. Similarly, CMS is proposing to 
reinstate references to sexual orientation and gender identity in the 
Medicaid managed care regulation at 42 CFR 438.3(d)(4) that prohibits 
Medicaid managed care plans from discriminating against individuals 
eligible to enroll and from using any policy or practice that has the 
effect of discriminating on the basis of listed characteristics, which 
currently include race, color, national origin, sex, or disability. For 
consistency with the proposals elsewhere in this proposed rule to 
ensure that sexual orientation and gender identity are added and 
promote consistency across HHS programs for how protections against 
discrimination on the basis of sexual orientation or gender identify 
are reflected in regulation, we propose to revise the term ``sex'' in 
the current regulation text to ``sex (including sexual orientation and 
gender identity)'' at 42 CFR 438.206(c)(2) and 42 CFR 438.3(d)(4).
---------------------------------------------------------------------------

    \664\ 81 FR 27666.
    \665\ Id.
---------------------------------------------------------------------------

    CMS also proposes to add a similar nondiscrimination provision for 
CHIP, to apply to fee-for-service and managed care delivery systems, by 
incorporating 42 CFR 440.262 into CHIP regulations through a cross-
reference at 42 CFR 457.495(e). Because of existing cross-references in 
42 CFR 457.1201(d) and 457.1230(a), the amendments to the Medicaid 
managed care regulations at 42 CFR 438.3(d)(4) and 438.206(c)(2) would 
also apply to CHIP managed care entities.
    Finally, the Department proposes that if any of the provisions at 
CFR 457.495(e), 42 CFR 440.262, 42 CFR 438.206(c)(2) and 42 CFR 
438.3(d)(4) is held to be invalid or unenforceable by its terms, or as 
applied to any person or circumstance, it shall be severable from its 
respective sections and shall not affect the remainder thereof or the 
application of the provision to other persons not similarly situated or 
to other dissimilar circumstances. In enforcing the nondiscrimination 
provisions in these CMS regulations, HHS will comply with laws 
protecting the exercise of conscience and religion, including RFRA and 
all other applicable legal requirements.

B. Programs of All-Inclusive Care for the Elderly (PACE)

    CMS issued an interim final rule implementing the Programs of All-
Inclusive Care for the Elderly (PACE) on November 24, 1999.\666\ In 
response to comments received on the November 24, 1999 interim final 
rule, in a December 8, 2006 Final Rule,\667\ CMS added references to 
``sexual orientation'' to several PACE regulations intended to prevent 
discrimination against PACE participants, consistent with CMS' 
authority under sections 1894(f) and 1934(f) of the SSA. Specifically, 
CMS amended 42 CFR 460.98(b)(3) to prohibit PACE organizations from 
discriminating against any participant in the delivery of required PACE 
services based on sexual orientation, among other bases. Similarly, CMS 
modified Sec.  460.112(a) to affirmatively state that each PACE 
participant has the right not to be discriminated against in the 
delivery of required PACE services based on sexual orientation, among 
other bases.
---------------------------------------------------------------------------

    \666\ 64 FR 66234 (Nov. 24, 1999).
    \667\ 71 FR 71244 (Dec. 8, 2006).
---------------------------------------------------------------------------

    Congress authorized PACE under both Medicare and Medicaid, in 
sections 1894 and 1934 of the SSA, codified at 42 U.S.C. 1395eee and 42 
U.S.C. 1396u-4, respectively. For a description of the relevant 
legislative history, we direct readers to the December 8, 2006 Medicare 
and Medicaid Programs; Programs of All-Inclusive Care for the Elderly 
(PACE); Program Revisions final rule.\668\ Sections 1894(f) and 1934(f) 
of the SSA set forth the requirements for issuing regulations to carry 
out sections 1894 and 1934. Sections 1894(f)(2) and (3) and 1934(f)(2) 
and (3) include certain provisions relating to beneficiary and program 
protections under PACE. Sections 1894(f)(4) and 1934(f)(4) however, 
provide in identical terms that ``[n]othing in this subsection shall be 
construed as preventing the Secretary from including in regulations 
provisions to ensure the health and safety of individuals enrolled in a 
PACE program under this section that are in addition to those otherwise 
provided under paragraphs (2) and (3).'' This authority allows CMS to 
implement regulations to provide additional protections to ensure the 
health and safety of PACE participants in addition to those specified 
in sections 1894(f)(2) and (3) and 1934(f)(2) and (3).
---------------------------------------------------------------------------

    \668\ Id.
---------------------------------------------------------------------------

    PACE participants are some of CMS's most vulnerable and frail 
beneficiaries, with the vast majority dually eligible for both Medicare 
and Medicaid. To be eligible to enroll in a PACE program an individual 
must be determined to need the level of care required under the state 
Medicaid plan for coverage of nursing facility services.\669\ One of 
the purposes of the PACE program is to enable PACE participants to live 
in the community with the support of PACE services as long as medically 
and socially feasible, instead of residing in a nursing facility or 
other institutional setting.\670\ While PACE participants receive care 
in a wide range of settings, including the PACE center, the home, and 
inpatient facilities, given the general characteristics of the PACE 
population, PACE organization staff interact with PACE participants in 
much the same way that nursing facility staff work with long-term care 
residents who are not PACE participants. Given the role of the PACE 
organization and the frequent interactions between PACE staff and PACE 
participants, the need to ensure

[[Page 47894]]

discrimination does not occur is even greater.
---------------------------------------------------------------------------

    \669\ 42 CFR 460.150(b)(2).
    \670\ Id. at Sec.  460.4(b)(3).
---------------------------------------------------------------------------

    As addressed above, CMS now proposes, using its authority under 
section 1557 of the ACA and its authorities under sections 1894(f)(4) 
and 1934(f)(4) of the SSA, to amend PACE regulations at 42 CFR 
460.98(b)(3) and 460.112(a) to explicitly prohibit discrimination on 
the basis of sexual orientation or gender identity.
    Revised Sec.  460.98(b)(3) would state that PACE organizations may 
not discriminate against any participant in the delivery of required 
PACE services based on race, ethnicity, national origin, religion, sex 
(including sexual orientation and gender identity), age, mental or 
physical disability, or source of payment. Similarly, we are proposing 
to revise 42 CFR 460.112(a) to add references to ``sexual orientation'' 
and ``gender identity'' to establish a right for each PACE participant 
not to be discriminated against in the delivery of required PACE 
services on the basis of sexual orientation or gender identity. Revised 
Sec.  460.112(a) will provide in relevant part that each PACE 
participant has the right not to be discriminated against in the 
delivery of required PACE services based on race, ethnicity, national 
origin, religion, sex (including sexual orientation and gender 
identity), age, mental or physical disability, or source of payment.
    In addition, in the proposed rule, ``Patient Protection and 
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 
2023'' published in the Federal Register on January 5, 2022 (2023 
Payment Notice proposed rule),\671\ HHS proposed to amend certain 
regulations applicable to Exchanges, qualified health plans (QHPs), and 
certain issuers to prohibit discrimination based on sexual orientation 
and gender identity.\672\ That proposed rule discussed that LGBTQI+ 
individuals face pervasive health and health care disparities,\673\ and 
are at higher risk for many concomitant conditions and that overall, 
LGBTQI+ people report being in poorer health than non-LGBTQI+ 
individuals.\674\ The 2015 report, LGBT Older Adults in Long-Term Care 
Facilities, found that elders in this community are more likely to be 
single, childless, estranged from their biological family, and reliant 
on families of choice, such as friends and other loved ones, for 
informal support.\675\ Available research indicates that nursing home 
staff may be unfamiliar with the challenges and stigma faced by the 
LGBTQI community.\676\ Many of these nursing facilities studied also 
failed to have care plans in place that ensured the safety of their 
LGBTQ residents and lacked a meaningful appreciation for their specific 
history.\677\ One survey of nursing home social workers suggested that 
more than half of nursing home staff were ``either intolerant of 
homosexuality . . . or openly negative and condemnatory.'' \678\ 
Research suggests that nursing home staff may also fail to provide 
equal care to the LGBTQI+ community. For instance, research has shown 
that nursing home staff sometimes fail to provide basic care such as 
bathing, toileting, and feeding for LGBTQI+ residents at higher rates 
than for residents who are not, because of staff refusal to touch 
LGBTQI+ residents.\679\
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    \671\ 87 FR 584 (Jan. 5, 2022).
    \672\ As discussed infra section V.C., the Department did not 
finalize these provisions in the Payment Notice final rule (87 FR 
27208, 27209 (May 6, 2022)) because this proposed rule addressing 
Section 1557 also would address issues related to prohibited 
discrimination based on sex. Therefore, the Department determined 
that it would be most prudent to address the nondiscrimination 
proposals related to sexual orientation and gender identity in this 
Section 1557 proposed rule to ensure consistency across the policies 
and requirements applicable to entities subject to Section 1557.
    \673\ See, e.g., Lesbian, Gay, Bisexual, and Transgender Health, 
Healthy People 2020, HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health (last visited June 15, 2022); 
Hudaisa Hafeez et al., Healthcare Disparities Among Lesbian, Gay, 
Bisexual, and Transgender Youth: A Literature Review, 9 Cureus e1184 
(2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478215/; Karen 
I. Fredriksen-Goldsen et al., Health Disparities Among Lesbian, Gay, 
and Bisexual Older Adults: Results from a Population-Based Study, 
103 A.m. J. Pub. Health 1802 (2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3770805/; Billy A. Caceres et al., A Systematic 
Review of Cardiovascular Disease in Sexual Minorities, 107 A.m. J. 
Public Health e13-e21 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5343694/.
    \674\ Daniel, supra note 119.
    \675\ Nat'l Senior Citizens Law Center et al., LGBT Older Adults 
in Long-Term Care Facilities (last updated 2015), https://www.lgbtagingcenter.org/resources/pdfs/NSCLC_LGBT_report.pdf.
    \676\ Alan Moses, A Second ``Closet'' for Some LGBTQ Seniors 
Entering Nursing Homes, U.S. News (Aug. 10, 2021), https://www.usnews.com/news/health-news/articles/2021-08-10/a-second-closet-for-some-lgbtq-seniors-entering-nursing-homes.
    \677\ Id.
    \678\ David Henry Wolfenson, The Risks to LGBT Elders in Nursing 
Homes and Assisted Living Facilities and Possible Solutions, 26 Tul. 
J. L. & Sexuality 123 (2017), https://journals.tulane.edu/tjls/article/view/3020/2812.
    \679\ Id.
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    As described earlier in this section, the functions filled by PACE 
organization staff are often similar to those filled by nursing home 
staff (e.g., bathing, toileting, and feeding). Since the functions are 
similar, PACE organizations would typically employ people with the same 
training and education as nursing home staff. Therefore, it is 
reasonable to assume that nursing home staff and PACE staff might treat 
individuals in much the same way. In fact, since PACE staff are 
generally required to have one year of experience working with the 
frail or elderly population,\680\ which is similar to the population 
with which nursing home staff work, it is also reasonable to assume 
that nursing home staff might transfer to a PACE organization. As a 
result, we believe that PACE participants, regardless of the care 
setting, may encounter the same or similar issues as nursing home 
residents when receiving services from the PACE organization.
---------------------------------------------------------------------------

    \680\ See 42 CFR 460.64(a)(3).
---------------------------------------------------------------------------

    As explained earlier in this section of this proposed rule, 
research on nursing home care indicates that LGBTQI+ individuals often 
do not receive the health care needed to maintain and improve their 
overall health status. Since PACE participants have similarities to 
nursing home residents, we believe many of the same nursing home 
concerns might affect the provision of the benefits PACE organizations 
are required to provide under Sec.  460.92(a). As discussed supra 
section II.B., LGBTQI+ individuals experience high rates of health 
disparities.
    The PACE benefit package for all participants, regardless of the 
source of payment, must include all Medicare-covered services; all 
Medicaid-covered services, as specified in the State's approved 
Medicaid plan; and other services determined necessary by the 
participant's interdisciplinary team (IDT) to improve and maintain the 
participant's overall health status.\681\ Decisions by the IDT to 
provide or deny services must be based on an evaluation of the 
participant's current medical, physical, emotional and social needs and 
current clinical practice guidelines and professional standards of care 
applicable to the particular service.\682\ Furthermore, the IDT must 
perform an initial in-person comprehensive assessment of each 
participant.\683\ This includes evaluating the physical and cognitive 
function and ability of each participant, the participant's and 
caregiver's preferences for care, socialization and availability of 
family support, current health status and treatment needs, and other 
factors. These requirements are intended to ensure that the IDT makes 
decisions based on the unique needs of each

[[Page 47895]]

PACE participant. Discriminatory decision-making is inconsistent with 
these overall standards for how PACE organizations must furnish 
services.
---------------------------------------------------------------------------

    \681\ Id. at Sec.  460.92(a).
    \682\ Id. at Sec.  460.92(b).
    \683\ Id. at Sec.  460.104(a).
---------------------------------------------------------------------------

    We believe that expressly prohibiting discrimination based on 
sexual orientation or gender identity in these regulations could lead 
to improved health outcomes for PACE participants.\684\ Without robust 
protection from such discrimination, PACE participants may face, or 
continue to face, barriers to accessing medically necessary health 
care, and PACE participants who are transgender individuals may face 
additional barriers to, or be denied, clinically appropriate gender-
affirming care.
---------------------------------------------------------------------------

    \684\ Brian W. Ward et al., U.S. Dep't of Health & Human Servs., 
Ctrs. for Disease Control & Prevention, National Health Statistics 
Report: Sexual Orientation & Health Among U.S. Adults: National 
Health Interview Survey, 2013 (2014), https://www.cdc.gov/nchs/data/nhsr/nhsr077.pdf.
---------------------------------------------------------------------------

    Sections 1894(f)(4) and 1934(f)(4) of the SSA provide authority for 
the establishment of beneficiary safeguards to ensure the health and 
safety of all PACE participants, including ensuring they have access to 
all required PACE items and services. We are proposing changes to 42 
CFR 460.98(b)(3) and 460.112(a) to ensure the health and safety of PACE 
participants by establishing express protections against discriminatory 
actions based on sexual orientation and gender identity.
    Finally, the Department proposes that if any of the provisions at 
42 CFR 460.98(b)(3) and 460.112(a) is held to be invalid or 
unenforceable by its terms, or as applied to any person or 
circumstance, it shall be severable from its respective sections and 
shall not affect the remainder thereof or the application of the 
provision to other persons not similarly situated or to other 
dissimilar circumstances. In enforcing the nondiscrimination provisions 
in these CMS regulations, HHS will comply with laws protecting the 
exercise of conscience and religion, including RFRA and all other 
applicable legal requirements.

C. Insurance Exchanges and Group and Individual Health Insurance 
Markets

    LGBTQI+ people face barriers to obtaining appropriate health care, 
including access to insurance and coverage for needed services. For 
these reasons--as discussed in greater detail throughout this preamble 
related to access to nondiscriminatory health coverage--and given the 
Department's goal to ensure consistency across its nondiscrimination 
policies and programs and entities subject to Section 1557 as discussed 
previously, the Department here proposes to amend 45 CFR 147.104, 
155.120, 155.220, 156.200, and 156.1230, so that they explicitly 
identify and recognize discrimination on the basis of sexual 
orientation and gender identity as prohibited forms of discrimination 
based on sex.
    The Department proposed similar amendments to these same 
regulations in the 2023 Payment Notice proposed rule. However, because 
this proposed rule addressing Section 1557 also would address issues 
related to prohibited discrimination based on sex, the Department 
determined that it would be most prudent to address the 
nondiscrimination proposals related to sexual orientation and gender 
identity in this proposed rule to ensure consistency across the 
policies and requirements applicable to entities subject to Section 
1557. When issuing a final rule on the provisions proposed in this 
rule, we intend to also respond to the comments already submitted on 
the similar proposal included in the 2023 Payment Notice proposed rule. 
Accordingly, there is no need for entities that commented on these 
proposals in the 2023 Payment Notice proposed rule to submit 
duplicative comments.
    As described above, Section 1557 prohibits discrimination in health 
programs or activities, any part of which receives Federal financial 
assistance. Similarly, as the Department noted in the 2020 Rule, CMS 
also possesses statutory authority to prohibit discrimination in the 
Exchanges. CMS relies on these authorities for the proposed revisions 
discussed in section V.C.1 of the preamble.\685\ In the respective 
preambles to Sec. Sec.  155.120(c), 155.220(j), 156.200(e), and 
156.1230(b), CMS identifies and discusses the specific statutory 
authorities (in addition to Section 1557) that CMS relies upon for the 
proposals to prohibit discrimination based on sexual orientation and 
gender identity. Relying on authority separate from Section 1557, CMS 
also re-proposes the revision and clarification discussed in section 
V.C.2 of the preamble, related to Sec. Sec.  147.104 and 156.125. 
Section 147.104 applies to issuers offering non-grandfathered health 
insurance coverage in the group and individual markets, and Sec.  
156.125 applies to issuers offering non-grandfathered health insurance 
coverage in the small group and individual markets. Both of these 
provisions therefore apply to issuers that may not be entities covered 
by Section 1557. For this reason, CMS does not rely on Section 1557 
authority with respect to these provisions.
---------------------------------------------------------------------------

    \685\ 85 FR 37160, 37219, 37218-21 (June 19, 2020).
---------------------------------------------------------------------------

    Finally, the Department proposes that if any of the provisions at 
45 CFR 147.104(e), 155.120(c), 155.220(j), 156.200(e), or 156.1230(b) 
is held to be invalid or unenforceable by its terms, or as applied to 
any person or circumstance, it shall be severable from its respective 
sections and shall not affect the remainder thereof or the application 
of the provision to other persons not similarly situated or to other 
dissimilar circumstances. In enforcing the nondiscrimination provisions 
in these CMS regulations, HHS will comply with laws protecting the 
exercise of conscience and religion, RFRA and all other applicable 
legal requirements.
1. Health Insurance Exchanges
a. Non-interference With Federal Law and Nondiscrimination Standards 
(Sec.  155.120)
    Section 155.120(c) currently provides that in order to avoid 
interference and comply with applicable nondiscrimination statutes, the 
states and the Exchanges must not discriminate based on race, color, 
national origin, disability, age, or sex. Previously, in the final rule 
``Patient Protection and Affordable Care Act; Establishment of 
Exchanges and Qualified Health Plans; Exchange Standards for 
Employers'' (Exchange Standards final rule), pursuant to the authority 
provided in section 1321(a)(1)(A) of the ACA to regulate the 
establishment and operation of an Exchange, the Department finalized 
Sec.  155.120(c) to also prohibit discrimination based on sexual 
orientation and gender identity.\686\ The 2020 Rule removed the terms 
``sexual orientation'' and ``gender identity'' from the regulation 
text. For the reasons stated earlier in section V.C. of the preamble, 
for consistency with the proposals elsewhere in this proposed rule, to 
ensure that sexual orientation and gender identity are added, and to 
promote consistency across HHS programs, we propose to amend 45 CFR 
155.120(c) by revising ``sex'' to ``sex (including sexual orientation 
and gender identity)''.
---------------------------------------------------------------------------

    \686\ 77 FR 18310 (Mar. 27, 2012).
---------------------------------------------------------------------------

    In addition to the Section 1557 authority discussed above, section 
1312(a)(1)(A) of the ACA also authorizes CMS to prohibit discrimination 
in Exchanges pursuant to the authority to establish requirements with 
respect to the operation of Exchanges.\687\ Pursuant

[[Page 47896]]

to this authority, HHS finalized in the Exchange Standards final rule 
that a State must comply with any applicable nondiscrimination 
statutes, specifically finalizing that a State must not operate an 
Exchange in such a way as to discriminate on the basis of race, color, 
national origin, disability, age, sex, gender identity, or sexual 
orientation. CMS proposes to exercise that same authority here to amend 
Sec.  155.120(c) to again prohibit states and Exchanges carrying out 
Exchange requirements from discriminating based on sexual orientation 
and gender identity. Section 1321(a)(1)(A) of the ACA is the same 
authority CMS relies upon for implementation of existing 
nondiscrimination protections at Sec.  155.120(c) that currently 
prohibit discrimination on the basis of race, color, national origin, 
disability, age, or sex.
---------------------------------------------------------------------------

    \687\ 85 FR 37218-21.
---------------------------------------------------------------------------

    We seek comment on this proposal. However, we note that the 
Department proposed similar amendments to this section in the 2023 
Payment Notice proposed rule. Accordingly, there is no need for 
entities that commented on these proposals in the 2023 Payment Notice 
proposed rule to submit duplicative comments.
b. Federally-Facilitated Exchange Standards of Conduct (Sec.  155.220)
    Section 155.220(j)(2)(i) currently states that an agent, broker or 
web-broker that assists with or facilitates enrollment through a 
Federally-facilitated Exchange or assists individuals in applying for 
advance payment of the premium tax credit and cost-sharing reductions 
for QHPs sold through a Federally-facilitated Exchange must provide 
consumers with correct information, without omission of material fact, 
regarding the Federally-facilitated Exchange, QHPs offered through the 
Federally-facilitated Exchange, 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 to believe they are visiting HealthCare.gov), coercive, or 
discriminates based on race, color, national origin, disability, age, 
or sex. This provision also applies to agents, brokers, and web-brokers 
in State-based Exchanges on the Federal platform under Sec.  
155.220(l). Previously, in the Patient Protection and Affordable Care 
Act; HHS Notice of Benefit and Payment Parameters for 2017 (2017 
Payment Notice final rule),\688\ we finalized Sec.  155.220(j)(2)(i) to 
also prohibit discrimination based on sexual orientation and gender 
identity. The 2020 Rule removed the terms ``sexual orientation'' and 
``gender identity'' from the regulation text. For the reasons stated 
earlier in section V.C. of the preamble, for consistency with the 
proposals elsewhere in this proposed rule, to ensure that sexual 
orientation and gender identity are added, and to promote consistency 
across HHS programs, the Department proposes to amend 45 CFR 
155.220(j)(2)(i) by revising ``sex'' to ``sex (including sexual 
orientation and gender identity)''.
---------------------------------------------------------------------------

    \688\ 81 FR 12204 (May 9, 2016).
---------------------------------------------------------------------------

    In addition to Section 1557 authority discussed above, section 
1312(e) of the ACA grants CMS independent statutory authority to 
establish procedures for States to permit agents and brokers to enroll 
consumers in QHPs through the Federally-facilitated Exchanges, as 
described in Sections 1312(e) of the ACA, and the authority to 
establish requirements with respect to the operation of Exchanges, the 
offering of QHPs through such Exchanges, and other requirements as the 
Secretary determines appropriate under Sections 1321(a)(1)(A), (B), and 
(D) of the ACA. Pursuant to this authority, in the 2017 Payment Notice 
final rule, HHS finalized at Sec.  155.220 standards of conduct for 
agents and brokers that assist consumers to enroll in coverage through 
the Federally-facilitated Exchanges to protect consumers and ensure the 
proper administration of the Federally-facilitated Exchanges, including 
nondiscrimination standards at Sec.  155.220(j)(2)(i) that prohibited 
agents, brokers and web-brokers described in paragraph (j)(1) from 
discriminating based on sexual orientation and gender identity. CMS 
further explained that such standards of conduct were necessary to 
protect against agent and broker conduct that is harmful towards 
consumers, or that prevents the efficient operation of the Federally-
facilitated Exchanges. CMS proposes to exercise that same authority 
here to amend Sec.  155.220(j)(2)(i) to again prohibit an individual or 
entity described in paragraph (j)(1) from discriminating based on 
sexual orientation and gender identity. Sections 1312(e) and 
1321(a)(1)(A), (B), and (D) of the ACA are the same authorities CMS 
relies upon for implementation of existing nondiscrimination 
protections at Sec.  155.220(j)(2)(i).
    We seek comment on this proposal. However, we note that the 
Department proposed similar amendments to this section in the 2023 
Payment Notice proposed rule. Accordingly, there is no need for 
entities that commented on these proposals in the 2023 Payment Notice 
proposed rule to submit duplicative comments.
c. QHP Issuer Participation Standards (Sec.  156.200)
    Section 156.200(e) states that a QHP issuer must not, with respect 
to its QHP, discriminate on the basis of race, color, national origin, 
disability, age, or sex. Previously, in the Patient Protection and 
Affordable Care Act; Establishment of Exchanges and Qualified Health 
Plans; Exchange Standards for Employers'' (2012 Exchange Standards) 
final rule, we finalized Sec.  156.200(e) to also prohibit 
discrimination based on sexual orientation and gender identity.\689\ In 
the ``Patient Protection and Affordable Care Act; Standards Related to 
Essential Health Benefits, Actuarial Value, and Accreditation; Final 
Rule'' (EHB final rule), we finalized at Sec.  156.125 that the 
nondiscrimination requirements in Sec.  156.200 also apply to all 
issuers required to provide coverage of EHB, thereby prohibiting 
discrimination based on factors such as sexual orientation and gender 
identity.\690\ (See further discussion of Sec.  156.125 in section 
V.C.2 of this preamble.) The 2020 Rule removed the terms ``sexual 
orientation'' and ``gender identity'' from the regulation text. For the 
reasons stated earlier in section V.C. of the preamble, for consistency 
with the proposals elsewhere in this proposed rule, to ensure that 
sexual orientation and gender identity are added, and to promote 
consistency across HHS programs, we propose to amend 45 CFR 156.200(e) 
by revising ``sex'' to ``sex (including sexual orientation and gender 
identity)''.
---------------------------------------------------------------------------

    \689\ 77 FR 18310.
    \690\ 78 FR 12834 (Feb. 25, 2013).
---------------------------------------------------------------------------

    In addition to the Section 1557 authority discussed above, section 
1311(c)(1)(A) of the ACA gives CMS the statutory authority to prohibit 
discrimination by QHP issuers. Accordingly, CMS requires QHP issuers to 
comply with applicable state laws and regulations regarding marketing 
by health insurance issuers and not employ marketing practices or 
benefit designs that will have the effect of discouraging the 
enrollment of individuals with significant health needs. CMS is 
authorized to interpret and implement this requirement, and to set 
additional requirements for QHPs under its authority to establish 
requirements with respect to the offering of QHPs through the Exchanges 
in section 1321(a)(1)(B) of the ACA.\691\ Pursuant to this authority to 
set QHP standards in

[[Page 47897]]

section 1321(a)(1)(B) of the ACA, HHS finalized in the 2012 Exchange 
Standards final rule requirements at Sec.  156.200(e) intended to 
protect enrollees and potential enrollees from discriminatory 
practices, including on the basis of sexual orientation and gender 
identity. CMS proposes to exercise that same authority here to amend 
Sec.  156.200(e) to again prohibit QHPs from discriminating based on 
sexual orientation and gender identity. Section 1321(a)(1)(B) of the 
ACA is the same authority CMS relies upon for implementation of 
existing nondiscrimination protections at Sec.  156.200(e).
---------------------------------------------------------------------------

    \691\ 85 FR 37218-37221.
---------------------------------------------------------------------------

    We seek comment on this proposal. However, we note that the 
Department proposed similar amendments to this section in the 2023 
Payment Notice proposed rule. Accordingly, there is no need for 
entities that commented on these proposals in the 2023 Payment Notice 
proposed rule to submit duplicative comments.
d. Direct Enrollment With the QHP Issuer in a Manner Considered To Be 
Through the Exchange (Sec.  156.1230)
    Section 156.1230(b)(2) states that the QHP issuer must provide 
consumers with correct information, without omission of material fact, 
regarding the Federally-facilitated Exchange, QHPs offered through the 
Federally-facilitated Exchange, and insurance affordability programs, 
and refrain from marketing or conduct that is misleading a consumer 
into believing they are visiting HealthCare.gov, coercive, or 
discriminates based on race, color, national origin, disability, age, 
or sex. Previously, in the 2017 Payment Notice final rule (81 FR 12203 
(May 9, 2016)), HHS finalized at Sec.  155.220(j)(2)(i) standards that 
prohibited agents, brokers and web-brokers from discriminating on the 
basis of sexual orientation and gender identity, among other factors. 
In the Patient Protection and Affordable Care Act; HHS Notice of 
Benefit and Payment Parameters for 2018 (2018 Payment Notice final 
rule), we added this nondiscrimination standard from Sec.  155.220(j) 
to Sec.  156.1230(b), so that the nondiscrimination protections on the 
basis of sexual orientation and gender identity also applied to issuers 
using direct enrollment on a Federally-facilitated Exchange.\692\ The 
2020 Rule removed the terms ``sexual orientation'' and ``gender 
identity'' from the regulation text. For the reasons stated earlier in 
section V.C. of the preamble, for consistency with the proposals 
elsewhere in this proposed rule, to ensure that sexual orientation and 
gender identity are added, and to promote consistency across HHS 
programs, we propose to amend 45 CFR 156.1230(b)(2) by revising ``sex'' 
to ``sex (including sexual orientation and gender identity)''.
---------------------------------------------------------------------------

    \692\ 81 FR 94058 (Dec. 22, 2016).
---------------------------------------------------------------------------

    In addition to Section 1557 authority discussed above, section 
1321(a)(1)(A), (B), and (D) of the ACA gives CMS statutory authority to 
prohibit discrimination in enrollment through the Exchanges by issuers 
of QHPs--namely the authority to establish requirements with respect to 
the operation of Exchanges, the offering of QHPs through such 
Exchanges, and other requirements as the Secretary determines 
appropriate. Pursuant to this authority, in the 2018 Payment Notice 
final rule, HHS finalized at Sec.  156.1230(b)(2) standards applicable 
to issuers using direct enrollment on a Federally-facilitated Exchange 
to require that issuers refrain from marketing or conduct that is 
misleading, coercive, or discriminatory, including on the basis of 
sexual orientation or gender identity. HHS explained it was adding this 
nondiscrimination standard from Sec.  155.220(j) to Sec.  156.1230(b) 
so that the nondiscrimination protections on the basis of sexual 
orientation and gender identity also applied to issuers using direct 
enrollment on a Federally-facilitated Exchange. HHS proposes to 
exercise that same authority here to amend Sec.  156.1230(b) to again 
prohibit issuers using direct enrollment on a Federally-facilitated 
Exchange from discriminating based on sexual orientation and gender 
identity. Sections 1321(a)(1)(A), (B), and (D) of the ACA are the same 
authority CMS relies upon for implementation of existing 
nondiscrimination protections at Sec.  156.200(e).
    We seek comment on this proposal. However, we note that the 
Department proposed similar amendments to this section in the 2023 
Payment Notice proposed rule. Accordingly, there is no need for 
entities that commented on these proposals in the 2023 Payment Notice 
proposed rule to submit duplicative comments.
2. Prohibition of Discrimination--Group and Individual Health Insurance 
Markets
a. Guaranteed Availability of Coverage (Sec.  147.104)
    Section 147.104(e) states that a health insurance issuer and its 
officials, employees, agents, and representatives must not 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. Pursuant to 
section 1311(c)(1)(A) of the ACA, the HHS Secretary was required to 
establish by regulation criteria for certification that require QHP 
issuers to meet marketing requirements and not employ marketing 
practices or benefit designs that will have the effect of discouraging 
the enrollment of individuals with significant health needs in QHPs. As 
discussed in section V.C.2.c. of this preamble, under the authority of 
section 1321(a) of the ACA, which provides the HHS Secretary broad 
rulemaking authority with respect to the establishment and operation of 
Exchanges and the offering of QHPs through such Exchanges, in the 2012 
Exchange Standards final rule, CMS codified a regulation implementing 
prohibitions on discrimination by QHP issuers at Sec. Sec.  156.200(e) 
and 156.225(b).\693\ Under the authority in section 2702 of the PHS Act 
as well as the general rulemaking authority in section 2792 of the PHS 
Act, which provides the HHS Secretary broad rulemaking authority to 
promulgate regulations as may be necessary or appropriate to carry out 
the provisions of title XXVII of the PHS Act, the ``Patient Protection 
and Affordable Care Act; Health Insurance Market Rules; Rate Review'' 
final rule adopted a similar standard in Sec.  147.104(e), applying 
this requirement market-wide to issuers offering non-grandfathered 
plans in the group and individual health insurance markets, regardless 
of whether the coverage is offered through or outside of an 
Exchange.\694\
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    \693\ 77 FR 18310.
    \694\ 78 FR 13406 (Feb. 27, 2013).
---------------------------------------------------------------------------

    For the proposal to amend Sec.  147.104, CMS relies on its 
authorities under sections 2702 and 2792 of the PHS Act, which provide 
the HHS Secretary broad rulemaking authority to promulgate regulations 
as may be necessary or appropriate to carry out the provisions of title 
XXVII of the PHS Act. These are the same authorities CMS relies upon 
for implementation of existing nondiscrimination protections at Sec.  
147.104(e). Utilizing these same authorities to again prohibit 
discrimination based on sexual orientation and gender identity would be 
consistent with the authority CMS relies upon for those existing

[[Page 47898]]

protections at Sec.  147.104(e) that currently prohibit discrimination 
on the basis of 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.
    CMS does not propose to rely on Section 1557 authority for this 
amendment for two primary reasons. First, Sec.  147.104 applies to non-
grandfathered health insurance coverage in the individual or group 
market, and not all of such issuers will receive Federal financial 
assistance such that they would be subject to Section 1557. Second, 
under PHS Act section 2723, states have primary enforcement authority 
over issuers with respect to regulations implementing title XXVII of 
the PHS Act, including Sec.  147.104. If CMS determines that a state is 
not substantially enforcing a provision in title XXVII, then CMS may 
enforce the provision's requirements. Because states would not have 
authority to enforce Section 1557, CMS is of the view that partial 
reliance on Section 1557 authority could unnecessarily complicate 
enforcement efforts.
    For the reasons stated earlier in section V.C. of the preamble, for 
consistency with the proposals elsewhere in this proposed rule, to 
ensure that sexual orientation and gender identity are added, and to 
promote consistency across HHS programs, we propose to amend 45 CFR 
147.104(e) by revising ``sex'' to ``sex (including sexual orientation 
and gender identity)''.
    We seek comment on this proposal. However, we note that the 
Department proposed similar amendments to this section in the 2023 
Payment Notice proposed rule. Accordingly, there is no need for 
entities that commented on these proposals in the 2023 Payment Notice 
proposed rule to submit duplicative comments.
b. Prohibition on Discrimination (Sec.  156.125)
    Elsewhere in this rule, we propose to amend Sec.  156.200(e) to 
prohibit discrimination based on sexual orientation and gender 
identity. If these proposed nondiscrimination protections are 
finalized, Sec.  156.125(b) would accordingly require issuers providing 
EHB to comply with such nondiscrimination requirements. Specifically, 
Sec.  156.125(b) states that an issuer providing EHB must comply with 
the requirements of Sec.  156.200(e), which currently states that a QHP 
issuer must not, with respect to its QHP, discriminate on the basis of 
race, color, national origin, disability, age, or sex. HHS previously 
codified nondiscrimination protections based on sexual orientation and 
gender identity at Sec.  156.200(e), simultaneously requiring that 
issuers providing EHB comply with such requirements by virtue of the 
cross-reference in Sec.  156.125(b) to Sec.  156.200(e). The 2020 Rule 
amendments removed from Sec.  156.200(e) any reference to sexual 
orientation and gender identity. As discussed in section V.C.1.c of the 
preamble, we propose to amend 45 CFR 156.200(e) by revising ``sex'' to 
``sex (including sexual orientation and gender identity)''.
    If the proposals at Sec.  156.200(e) are finalized, issuers 
providing EHB would again be required under Sec.  156.125(b) to comply 
with nondiscrimination protections in Sec.  156.200(e) that prohibit 
discrimination on the basis of sexual orientation and gender identity.
    Section 1302(b) of the ACA also gives CMS the statutory authority 
to prohibit discrimination in the small group and individual markets 
pursuant to the authority to define EHB at section 1302(b) of the ACA. 
The statute specifies that in defining EHB the Secretary must take into 
account the health care needs of diverse segments of the population, 
including women, children, persons with disabilities, and other groups. 
The EHB requirements apply to non-grandfathered health insurance 
coverage in the individual and small group markets under section 
2707(a) of the PHS Act. CMS has the authority to interpret and 
implement these provisions under its general rulemaking authorities in 
sections 1321(a)(1)(B) and (D) of the ACA and section 2792 of the PHS 
Act. Pursuant to those authorities, HHS finalized in the EHB final rule 
that Sec.  156.125 prohibits benefit discrimination on the grounds 
articulated by Congress in section 1302(b)(4) of the ACA, as well as 
those in Sec.  156.200(e), which at the time included race, color, 
national origin, disability, age, sex, gender identity, and sexual 
orientation. It is under that same exercise of authority here that 
Sec.  156.125 would again prohibit discrimination on the basis of 
sexual orientation and gender identity if the proposed changes to 
include such factors in the nondiscrimination protections at Sec.  
156.200(e) are finalized. Sections 1302(b) and 1321(a)(1)(B) and (D) of 
the ACA and sections 2707(a) and 2792 of the PHS Act are the same 
authorities CMS relies upon for implementation of existing 
nondiscrimination protections at Sec.  156.125. Relying on these same 
authorities to again prohibit discrimination based on sexual 
orientation and gender identity at Sec.  156.125 by cross-reference to 
the nondiscrimination protections at Sec.  156.200(e) would be 
consistent with the authority CMS relies upon for the existing 
protections at Sec.  156.125 that prohibit discrimination on the basis 
of race, color, national origin, disability, age, or sex by cross-
reference to Sec.  156.200(e).
    CMS does not rely on Section 1557 authority for this amendment for 
the same two primary reasons described in section V.C.2.a of this 
preamble. First, Sec.  156.125 applies to issuers offering non-
grandfathered health insurance coverage in the individual or small 
group market, and not all of such issuers will receive Federal 
financial assistance such that they would be subject to Section 1557. 
Second, under PHS Act section 2723, states have primary enforcement 
authority over issuers with respect to regulations implementing title 
XXVII of the PHS Act, including Sec.  156.125. If CMS determines that a 
state is not substantially enforcing a provision in title XXVII, then 
CMS may enforce the provision's requirements. Because states would not 
have authority to enforce Section 1557, CMS is of the view that partial 
reliance on Section 1557 authority could unnecessarily complicate 
enforcement efforts.
    We seek comment on this proposal. However, we note that the 
Department proposed similar amendments to this section in the 2023 
Payment Notice proposed rule. Accordingly, there is no need for 
entities that commented on these proposals in the 2023 Payment Notice 
proposed rule to submit duplicative comments.

VI. Executive Order 12866 and Related Executive Orders on Regulatory 
Review

A. Regulatory Impact Analysis

    We have examined the impacts of the proposed rule under E.O. 12866, 
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.'s 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). This proposed rule is an 
economically significant regulatory action as defined by E.O. 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the costs of the proposed rule

[[Page 47899]]

are small relative to the revenue of covered entities, including 
covered small entities, and because even the smallest affected entities 
would be unlikely to face a significant impact, we propose to certify 
that the proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) generally 
requires us to prepare a written statement, which includes an 
assessment of anticipated costs and benefits, before proposing ``any 
rule that includes any Federal mandate that may result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted annually 
for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $165 million, using the most current (2021) 
Implicit Price Deflator for the Gross Domestic Product. This proposed 
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.\695\
---------------------------------------------------------------------------

    \695\ 2 U.S.C. 1503(2).
---------------------------------------------------------------------------

    The Background and Reasons for the Proposed Rulemaking sections at 
the beginning of this preamble contain a summary of this proposed rule 
and describe the reasons it is needed.
1. Summary of Costs and Benefits
    This analysis quantifies several categories of costs to covered 
entities and to the Department under the proposed rule. Specifically, 
we quantify costs associated with covered entities training employees, 
revising policies and procedures, and costs associated with notices, 
including the notice of nondiscrimination and notice of availability of 
language assistance services and auxiliary aids and services. We 
quantify costs associated with provisions of the proposed rule related 
to documenting training activities performed under the proposed rule. 
We also quantify incremental costs associated with expanded coverage 
for gender-transition-related medical care. We conclude that the 
proposed rule would result in annualized costs over a 5-year time 
horizon of $560 million or $551 million, corresponding to a 7% or a 3% 
discount rate. This analysis also addresses uncertainty in costs 
associated with notices and expanded gender-transition-related medical 
care, which is discussed in greater detail in the main body of the 
analysis. We separately report a full range of cost estimates of about 
$427 million to $1,093 million using a 7% discount rate, and a full 
range of cost estimates of about $417 million to $1,084 million using a 
3% discount rate.
    In addition to these quantified cost estimates, the main analysis 
includes a discussion of costs that we do not quantify, and a 
discussion of the potential benefits under the rule that we similarly 
do not quantify. In addition to the impacts that we quantify, this 
proposed rule could also result in increases in premiums, which would 
result in increases in Exchange user fees and Federal expenditures for 
advance payments of the premium tax credit. We request comments on our 
estimates of the cost and benefits of this proposed rule, including the 
impacts that are not quantified in this analysis.

                                                     Table 1--Annualized Costs of the Proposed Rule
                                                               [$ millions/year (percent)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     Primary estimate                       Low estimate    High estimate   Year dollars    Discount rate     Period covered (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
$560.....................................................            $427          $1,093            2020               7                     2024-2028
551......................................................             417           1,084            2020               3                     2024-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------

a. Baseline Conditions
    Section 1557 prohibits an individual from being excluded from 
participation in, denied the benefits of, or otherwise subjected to 
discrimination on the basis of race, color, national origin, sex, age, 
or disability in certain health programs and activities. It applies to 
any health program or activity, any part of which is receiving Federal 
financial assistance, and to any program or activity that is 
administered by an Executive Agency or any entity established under 
Title I of the ACA.\696\ On May 18, 2016, the Department published a 
final rule to implement Section 1557 under the statute and 5 U.S.C. 
301. On June 19, 2020, the Department published a final rule that 
revised the Department's approach to implementing Section 1557. As 
described in the Background section of this preamble in greater detail, 
neither final rule was fully implemented as published, and certain 
provisions of the 2020 Rule remain the subject of ongoing litigation. 
The Background section of the preamble also discusses the Department's 
May 10, 2021 Bostock Notification, in accordance with the Supreme 
Court's decision in Bostock and based on the plain language of Title 
IX, that the Department would interpret Section 1557's prohibition on 
sex discrimination to include (1) discrimination on the basis of sexual 
orientation and (2) discrimination on the basis of gender 
identity.\697\
---------------------------------------------------------------------------

    \696\ 42 U.S.C. 18116.
    \697\ 86 FR 27984 (May 25, 2021).
---------------------------------------------------------------------------

    The baseline scenario of no further regulatory action is 
substantially informed by the RIAs published with the 2016 and 2020 
Rules. The 2016 RIA identified five sources of monetized costs: 
training and familiarization, enforcement, notice publication, sex 
discrimination policy and procedure changes, and language access plans. 
The bulk of the monetary impacts identified in the 2016 RIA occur in 
the first two years under the final rule, with costs continuing in 
future years only for enforcement and language access plans.
    The 2020 RIA adopted many of the assumptions contained in the 2016 
RIA. For example, it assumed that many of the initial activities 
anticipated under the 2016 rule were performed, and that the first two 
years of costs attributable to the 2016 Final Rule were incurred.\698\ 
The 2020 RIA identifies cost savings only ``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.'' The 2020 
RIA also identifies costs in the first year ``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.''
---------------------------------------------------------------------------

    \698\ E.g., 85 FR 37160, 37235 (June 19, 2020) (``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.'').
---------------------------------------------------------------------------

    In establishing a baseline scenario, this analysis similarly 
maintains a number of assumptions and estimates contained in prior 
analyses. For

[[Page 47900]]

example, the baseline scenario includes some ongoing costs that are 
attributable to the 2016 Rule, such as the costs of enforcement. The 
2016 RIA estimated that the costs of enforcement would be $98.2 million 
(reported in 2020 dollars), which we adopt as the costs under both the 
baseline and proposed rule scenarios. Similarly, we adopt the 
assumption in the 2020 RIA that covered entities continue to provide 
ongoing training attributable to the 2016 Rule, which was not impacted 
by the 2020 Rule. We include these ongoing training activities, 
including annual refresher training for returning employees and 
training for new employees, in the baseline scenario of no regulatory 
action. In the next section, we discuss the incremental costs of the 
proposed rule, which exclude ongoing costs attributable to prior 
rulemaking.
b. Costs of the Proposed Rule
    This analysis anticipates that the proposed rule would result in 
one-time costs to covered entities to train employees and revise 
policies and procedures. The proposed rule would result in costs 
associated with a revised approach to notices, including the notice of 
nondiscrimination and notice of availability of language assistance 
services and auxiliary aids and services. The proposed rule would also 
result in costs associated with provisions related to documenting 
training activities performed under the proposed rule. The proposed 
rule might result in additional costs associated with expanded coverage 
for gender-transition-related medical care. We discuss the potential 
costs associated with this expanded coverage and the potential that 
some or all of these costs would be offset by reductions in spending on 
other types of care. The analysis also discusses other potential costs 
of the proposed rule that we do not quantify.
Training
    The Department anticipates that some covered entities would incur 
costs to train or retrain employees under the proposed rule. To 
calculate the costs related to training, we follow an approach common 
to both the 2016 and 2020 RIAs. Both analyses adopted an estimate of 
275,002 covered entities that would train their employees on the 
requirements and used this figure as the basis for calculating the 
total costs. The 2020 RIA adjusted this figure downwards by 50%, 
anticipating that some covered entities would not modify their 
procedures in response to the 2020 Final Rule, and would therefore not 
need to offer new training. Both RIAs anticipated that employers would 
most likely train employees who interact with the public and recognized 
that the percentage of employees that interact with patients and the 
public vary by covered entity. To account for this, the analyses 
adopted a central estimate of 50% of staff at covered entities that 
received one-time training on the requirements of the regulation.
    Both RIAs reported the number of employees at covered entities by 
occupation category. To monetize the total costs of training, the RIAs 
adopted a value of time based on the average fully loaded wage rate for 
each occupation, combined with an assumption about the duration of the 
training. The 2016 RIA assumed that 50% of total employees at covered 
entities would receive training, while the 2020 RIA assumed that 25% of 
employees would receive training. Both RIAs assumed the typical 
training would last one (1) hour. For the purpose of this analysis, we 
assume that 75% of total employees at covered entities would receive 
training, and that this training would last one (1) hour. This estimate 
is consistent with an assumption that all covered entities would revise 
their policies and procedures under the proposed rule, and that most 
employees at covered entities would receive training.
    As a necessary first step in calculating the incremental total 
costs of training attributable to the proposed rule, we have collected 
the most recent available data on the number of employees that would 
likely undergo training under the proposed rule, and data on the 
average wage rate by occupation for these employees.
    The first category of health care 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 U.S. 
Bureau of Labor Statistics (BLS) Occupational code for this grouping is 
29-1000, and the 2020 reported count for this occupational group is 
approximately 5.6 million, with average loaded wages of $101.16 per 
hour.
    The second category of health care staff that the Department 
assumes will receive training comprises degreed technical staff 
(Occupation code 29-2000) and accounts for 2.9 million workers with 
average loaded wages of $47.10 per hour. Technicians work in almost 
every area of health care: x-ray, physical, speech, psychiatric, 
dietetic, laboratory, nursing, and records technicians, to name but a 
few areas.
    The third category of health care 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. Health care 
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 5.9 million individuals employed 
in these occupations in the health care and social assistance sector, 
with average loaded wages of $30.72 per hour.
    The fourth category of health care staff that the Department 
assumes will receive training is health care managers (approximately 
0.4 million individuals based on BLS data for Occupation code 11-9111), 
with average loaded wages of $114.24 per hour.
    The fifth category of health care 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 2.7 million individuals were 
employed in these occupations in health facilities in 2020, with 
average loaded wages of $38.50 per hour. The Department assumes that 
outreach workers are included in the five categories listed above.
    These figures sum to 17.4 million employees at covered entities, of 
which we assume 13.1 million would receive training attributable to the 
proposed rule. Across the five occupation categories, we compute a 
weighted hourly wage rate of $29.59, or a weighted fully loaded hourly 
wage rate of $59.18. Assuming that the average training takes one (1) 
hour and adopting a value of time based on fully loaded wage rates, we 
estimate the total cost of training of about $775 million, which would 
be incurred in the first year. As a sensitivity analysis, we considered 
the scenario of covered entities providing training to all employees, 
not just employees who interact with the public. Under this scenario, 
the total cost of training would increase, to about $1.0 billion. These 
costs are likely overstated since this training may supplement or 
replace expected annual or other ongoing training activities at covered

[[Page 47901]]

entities. To the extent that covered entities reduce time spent on 
other training activities, these costs would offset some of the total 
costs attributable to the proposed rule.
    In addition to the first-year training costs, we anticipate that 
the proposed rule would result in additional costs associated with 
ongoing training, including annual refresher training for returning 
employees or and training for new employees. As discussed in the 
Baseline Conditions section, we assume that many covered entities are 
routinely carrying out these activities, absent further regulatory 
action. However, we anticipate that the proposed rule would result in a 
larger share of employees at covered entities receiving such training. 
To quantify the change in training activities between the baseline 
scenario and the proposed rule scenario, we take the difference between 
the share of employees receiving training under the baseline scenario 
and the proposed rule scenario. We carry through an assumption from the 
2016 RIA, which assumed that 50% of total employees at covered entities 
receive training and compare this to an assumption in this proposed RIA 
that 75% of total employees at covered entities would receive training. 
This yields an estimate of 25% of total employees at covered entities 
that would receive training in subsequent years under the proposed 
rule. We adopt the same weighted hourly wage estimate, number of 
employees, and estimate the total cost of ongoing annual training costs 
of $258 million. These costs would occur in years two through five in 
the time horizon of this analysis.

Revising Policies and Procedures

    As discussed above, the Department anticipates that all covered 
entities, or approximately 275,002 entities, would revise their 
policies and procedures under the proposed rule, with half of these 
entities requiring fewer revisions. For covered entities with more 
extensive revisions, we adopt the estimates contained in the 2020 RIA, 
with four (4) total hours spent on revisions per entity. Of these, 
three would be spent by a mid-level manager equivalent to a first-line 
supervisor (Occupation code 43-1011), at a cost of $56.96 per hour 
after adjusting for non-wage benefits and the indirect costs, 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 
$104.80 per hour after adjusting for non-wage benefits and indirect 
costs. For covered entities with less extensive revisions, we assume 
two total hours spent on revisions per entity. Of these, one would be 
spent by a mid-level manager, and one would be spent by executive 
staff.
    We monetize the time spent on revising policies and procedures by 
estimating a total cost per entity of $275.68 or $161.76, depending on 
the extent of the revisions. For the 137,501 covered entities with more 
extensive revisions, we estimate a cost of about $37.9 million. For the 
137,501 covered entities with less extensive revisions, we estimate a 
cost of about $22.2 million. We estimate the total cost associated with 
revisions to policies and procedures under the proposed rule of $60.1 
million.
    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.
Notices
    The proposed rule would require a covered entity to provide a 
notice of nondiscrimination to participants, beneficiaries, enrollees, 
and applicants of its health program or activity, and members of the 
public. It also would require the 275,002 covered entities to provide a 
notice of availability of language assistance services and auxiliary 
aids and services. These provisions resemble elements of the 2016 Rule 
that were repealed in the 2020 Rule; however, the approach under the 
proposed rule provides a narrower set of situations where covered 
entities would be required to provide these notices. Both types of 
notices are required (1) on an annual basis; (2) upon request; (3) at a 
conspicuous location on the covered entity's health program or activity 
website; and (4) in clear and prominent physical locations where the 
health program or activity interacts with the public.
    The notice of availability of language assistance services and 
auxiliary aids and services is required in the following electronic and 
written communications related to the covered entity's health programs 
and activities: (1) notice of nondiscrimination required by proposed 
Sec.  92.10; (2) notice of privacy practices required by 45 CFR 
164.520; (3) application and intake forms; (4) notices of denial or 
termination of benefits or services, including Explanations of Benefits 
(EOBs) and notices of appeal and grievance rights; (5) communications 
related to a person's rights, eligibility benefits, or services that 
require or request a response from a participant, beneficiary, 
enrollee, or applicant; (6) communications related to a public health 
emergency; (7) consent forms and instructions related to medical 
procedures or operations, medical power of attorney, or living will 
(with an option of providing only one notice for all documents bundled 
together); (8) discharge papers; (9) complaint forms; and (10) patient 
and member handbooks.
    For the purposes of the analysis, we base our estimates of the 
number of communications containing these notices on a subset of the 
communications identified in the 2020 RIA. We include communications 
that are EOBs. The Department received feedback regarding the financial 
burden imposed by applying the notice and tagline requirements to EOBs. 
EOBs are typically an individual's first, and often only, notice of a 
denial or termination of benefits or services, and as such the notice 
and tagline requirements are essential in this context to ensure timely 
and equitable access to appeals processes. Covered entities may provide 
individuals with the option to opt out of receiving these notices on an 
annual basis, which will reduce the cost and burden associated with 
these requirements. In addition, as enrollees, participants, and 
beneficiaries increasingly elect to receive EOBs electronically, we 
expect the cost of these requirements to decrease over time. We adopt 
the other estimates as a reasonable proxy for the number of 
communications that would be anticipated under the proposed rule. These 
estimates are intended to encompass all categories of notices required 
under the proposed rule. Table 2 below reports the number of 
communications containing notices anticipated under the proposed rule 
and presents the costs of these communications. Our cost estimates 
reflect a wide range of uncertainty in the cost per communication. For 
our primary scenario, we adopt a central estimate of the average costs 
to print and fold paper forms containing prescribing information of 
$0.05 (calculated as the midpoint estimate of a range from $0.03 to 
$0.07), reported in 2010 dollars.\699\ We explore the

[[Page 47902]]

sensitivity of the overall cost estimates under a low-cost ($0.035 per 
unit) and high-cost ($0.32 per unit) scenario, reported in 2018 
dollars, which matches the range contained in the 2020 RIA. We adjust 
these per-unit cost inputs for inflation to 2020 price levels using the 
Implicit Price Deflator, resulting in a primary per-unit cost estimate 
of about $0.06 and a full range of about $0.04 to $0.33.\700\ Combining 
these per-unit cost estimates with the count of each notice results in 
a primary estimate of $78.4 million, with a range of estimates between 
$47.8 million and $437.2 million. Following the approach in the 2020 
RIA, we adjust this figure downwards by 50% to account for the lower 
cost of electronic communications. For this adjustment, we adopt a 
measure of the share of respondents reporting that they used a 
``Digital (mobile app or website)'' method to contact or interact with 
their health care insurer in the last year when viewing an online 
statement.\701\ We anticipate that the share of communications 
occurring online will increase over time, but have not accounted for a 
trend for the 5-year time horizon of this analysis. This adjustment 
results in a primary estimate of the adjusted annual total of $78.4 
million, with a range of costs between $23.9 million and $218.6 
million. These costs would occur in each year of the time horizon of 
the analysis.
---------------------------------------------------------------------------

    \699\ U.S. Dep't of Health & Human Servs., Food & Drug Admin., 
Electronic Distribution of Prescribing Information for Human 
Prescriptions Drugs, Including Biological Products (Proposed Rule), 
79 FR 75506 (Dec. 18, 2014).
    \700\ Gross Domestic Product: Implicit Price Deflator (GFPDEF), 
Fed. Reserve Bank of St. Louis, https://fred.stlouisfed.org/series/GDPDEF (last visited June 15, 2022).
    \701\ Saurabh Gupta et al., HFS Res. & Cognizant, Health 
Consumers Want Digital: It's Time for Health Plans to Deliver, p. 4 
(2021), https://www.cognizant.com/us/en/documents/hfs-health-consumers-want-digital-its-time-for-health-plans-to-deliver.pdf.

                                       Table 2--Cost of Notice Provisions
                                                 [2020 dollars]
----------------------------------------------------------------------------------------------------------------
                                                                        Cost scenario ($ millions)
            Cost element               Count (millions) --------------------------------------------------------
                                                                Low              Primary              High
----------------------------------------------------------------------------------------------------------------
Eligibility and enrollment                         17.7               $0.7               $1.1               $6.0
 communications.....................
Annual notice of benefits...........              123.0                4.6                7.5               41.8
Explanations of benefits--hospital                 96.0                3.6                5.8               32.6
 admissions.........................
Explanations of benefits--physician               941.0               34.9               57.3              319.5
 visits.............................
Medical bills--hospital admissions..               11.0                0.4                0.7                3.7
Medical bills--physician visits.....               99.0                3.7                6.0               33.6
                                     ---------------------------------------------------------------------------
    Total, Unadjusted...............             1287.7               47.8               78.4              437.2
    Total, Adjusted for Electronic               1030.2               23.9               39.2              218.6
     Delivery.......................
----------------------------------------------------------------------------------------------------------------

Documentation Requirements
    The proposed rule would require covered entities to 
contemporaneously document certain other activities performed under the 
proposed rule. This includes activities such as employees' completion 
of the training required by this section in written or electronic form. 
The proposed rule also requires covered entities to retain certain 
records. These and other requirements, and the associated cost 
estimates, are discussed in greater detail in the PRA Section.
    The costs associated with retaining records related to grievances 
filed with a covered entity is the time spent by the staff of covered 
entities to store the complaints for no less than three (3) years. We 
calculate the costs of labor as one (1) employee per covered entity 
with more than 15 employees (41,250) \702\ spending 10 hours to store 
complaints and the associated records required under proposed Sec.  
92.8(c)(2) each year. We assume that administrative or clerical support 
personnel would perform these functions. The mean hourly wage for this 
occupation is $17.38 per hour, which we double to account for overhead 
and other indirect costs. We estimate the costs of retaining records 
related to grievances filed at all covered entities would be $14.3 
million annually ($17.38 x 2 x 10 x 41,250). This estimation approach 
will overstate the costs if many covered entities already retain 
complaint information.
---------------------------------------------------------------------------

    \702\ This estimate is consistent with the 2016 Rule's 
Regulatory Impact Analysis: ``Of the 275,002 covered entities, 
approximately 15% employ more than 15 employees, resulting in 
approximately only slightly more than 41,250 covered entities being 
required to have grievance procedures and designate a responsible 
official.'' 81 FR 31375, 31452 (May 18, 2016).
---------------------------------------------------------------------------

    The costs associated with documenting employee training is the time 
spent by the staff of covered entities to (a) create training 
attendance forms; and (b) store the training sign-up sheet. We 
calculate the costs of labor as one (1) employee spending 15 minutes 
(0.25 hours) to create the sign-up sheet during the first year and one 
(1) employee spending one (1) hour collecting and storing the 
attendance forms the first year and subsequent years. We assume that 
administrative or clerical support personnel would perform these 
functions. The mean hourly wage for this occupation is $17.38 per hour, 
which we double to account for overhead and other indirect costs. We 
estimate the costs of documenting employee training would be $11.9 
million in the first year ($17.38 x 2 x 1.25 x 275,002) and $9.6 
million in subsequent years ($1.738 x 2 x 1 x 275,002).
Expanding Coverage for Gender-Transition-Related Medical Care
    In addition to the cost some covered health insurance issuers and 
plans may incur for revising policies and procedures to comply with the 
rule, there is a possibility that such issuers and plans may incur a de 
minimis cost related to the cost of coverage for gender-transition-
related medical care. Various studies, however, suggest that any such 
increased costs will likely be negligible, and that any increases may 
be offset by savings from decreased utilization of other services.
    In April 2012, the California Department of Insurance conducted an 
Economic Impact Assessment on Gender Nondiscrimination in Health 
Insurance that found that covering transgender individuals under 
California's private and public health insurance plans would have an 
``insignificant and immaterial'' impact on costs.\703\ This conclusion 
was based

[[Page 47903]]

on evidence of low utilization and the estimated number of transgender 
individuals in California. The transgender population of California was 
estimated to range between 0.0022% and 0.0173%.\704\ The study revealed 
that, contrary to common assumptions, not all transgender individuals 
seek surgical intervention, and that gender-affirming health care 
differs according to the needs and pre-existing conditions of each 
individual.\705\ Despite expecting a possible spike in demand for 
benefits due to former or current unmet demand, the California 
Insurance Department concluded that any increased utilization that 
might occur over time is likely to be so low that any resulting costs 
remain actuarially immaterial.\706\ The Assessment notes the experience 
of one employer that initially established premium surcharges to cover 
the anticipated cost of transition-related care, reporting that the 
employer subsequently eliminated the surcharges because they found that 
the funds collected were nearly 15 times the amount expended on 
care.\707\ While it did not analyze any original data, a 2018 analysis 
by the state of Wisconsin's Department of Employee Trust Funds cited 
numerous studies finding that the cost of coverage was minimal, and 
noted that ``[w]hile it is challenging to predict the costs of care 
averted for any condition, there is some evidence that the costs 
associated with providing transgender-inclusive plans is met with 
reduced costs related to comorbidities.'' \708\
---------------------------------------------------------------------------

    \703\ State of Cal., Dep't of Ins., Economic Impact Assessment 
Gender Nondiscrimination in Health Insurance, p. 1 (Apr. 13, 2012), 
http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
    \704\ Id. at p. 3. More recent estimates indicate that a higher 
share of the population in the United States identifies as 
transgender (0.6% of the U.S. adult population), Andrew R. Flores et 
al., The Williams Inst., UCLA Sch. of Law, Race and Ethnicity of 
Adults Who Identify as Transgender in the United States, p. 2 
(2016), https://williamsinstitute.law.ucla.edu/wp-content/uploads/Race-Ethnicity-Trans-Adults-US-Oct-2016.pdf.
    \705\ State of Cal., Dep't of Ins., supra note 703, at p. 8.
    \706\ Id. at p. 9.
    \707\ Id. at pp. 6-7.
    \708\ State of Wis., Dep't of Employee Trust Funds, 
Correspondence Memorandum Re: Transgender Services Coverage, p. 6-8 
(Aug. 14, 2018), https://etf.wi.gov/boards/groupinsurance/2018/08/22/item6a1/download?inline=.
---------------------------------------------------------------------------

    Other studies looking at both public and private sector plans have 
reached similar conclusions. One study published in the New England 
Journal of Medicine projected that the cost for providing gender-
transition-related health care benefits to members of the military 
would result in an annual increase of 0.012% of health care costs, 
``little more than a rounding error in the military's $47.8 billion 
annual health care budget.'' \709\ A 2013 study of 34 public and 
private sector employers that provided nondiscriminatory health care 
coverage found that providing gender-transition-related benefits to 
treat gender dysphoria had ``zero to very low costs.'' \710\ A study 
comparing costs and potential savings associated with covering gender-
transition-related care concluded that projected ``additional expenses 
hold good value for reducing the risk of negative endpoints--HIV, 
depression, suicidality, and drug abuse'' and noted that ``provider 
coverage was cost-effective in 85% of simulations.'' \711\ More 
recently, a 2021 survey of employers conducted by the Human Rights 
Campaign noted that most employers who covered gender-transition-
related care reported only ``marginal increases'' in cost, on the order 
of ``a fraction of a decimal point of cost calculations.'' \712\
---------------------------------------------------------------------------

    \709\ Aaron Belkin, Caring for Our Transgender Troops--The 
Negligible Cost of Transition-Related Care, 373 New Eng. J. Med. 
1089 (2015), https://www.nejm.org/doi/pdf/10.1056/NEJMp1509230?articleTools=true.
    \710\ Jody Harman, The Williams Inst., UCLA Sch. of Law, Cost 
and Benefits of Providing Transition-Related Health Care Coverage in 
Employee Health Benefits Plans: Findings from a Survey of Employers, 
p. 2 (Sept. 2013), http://williamsinstitute.law.ucla.edu/wp-content/uploads/Herman-Cost-Benefit-of-Trans-Health-Benefits-Sept-2013.pdf.
    \711\ William V. Padula et al., Societal Implications of Health 
Insurance Coverage for Medically Necessary Services in the U.S. 
Transgender Population: A Cost-Effectiveness Analysis, 31 J. of Ged. 
Internal Med. 394 (2015),
    \712\ Human Rights Campaign, Corporate Equality Index 2021 
(2021), https://reports.hrc.org/corporate-equality-index-2021?_ga=2.206988627.1166715317.1639876655-819100514.1639876655.
---------------------------------------------------------------------------

    In recent years, some courts hearing challenges to coverage 
exclusions have also considered issues of cost and concluded that 
covering gender-transition-related care does not significantly increase 
costs for plans. In discussing the parties' experts on the issue of the 
cost, one court noted that, ``[f]rom an actuarial perspective, there 
appears to be no dispute that the cost of coverage is immaterial.'' 
\713\ Another court reviewing expert testimony called any cost savings 
from excluding coverage for gender-affirming care ``both practically 
and actuarially immaterial.'' \714\
---------------------------------------------------------------------------

    \713\ Boyden v. Conlin, 341 F. Supp. 3d 979, 1000 (W.D. Wis. 
2018).
    \714\ Flack v. Wisconsin Dep't of Health Servs., 395 F. Supp. 3d 
1001, 1021 (W.D. Wis. 2019); see also Kadel v. Folwell, No. 1:19-cv-
00272, 2022 WL 2106270, at *22 (``in comparison to the [Defendant 
state health plan]'s billion-dollar cash balance and saves each of 
the Plan's 740,000 members about one dollar each'').
---------------------------------------------------------------------------

    Based on the studies discussed above, we estimate that providing 
transgender individuals nondiscriminatory insurance coverage and 
treatment would have a small impact on the overall cost of care and on 
health insurance premiums in terms of the percentage of overall 
spending. The utilization rate of newly covered services is likely to 
be extremely low because the transgender individuals represent a small 
minority in the general population, because not all transgender 
individuals will seek medical care in the course of their transition, 
and because most entities will provide such care regardless of this 
proposed rule (i.e., they will not otherwise have engaged in prohibited 
sex discrimination).\715\
---------------------------------------------------------------------------

    \715\ State of Cal., Dep't of Ins., supra note 703, at pp. 2, 5.
---------------------------------------------------------------------------

    As described in this section, the costs associated with additional 
coverage of services are likely to be small on a percentage basis; 
however, when these estimates are combined with measures of overall 
health care spending, they would likely result in incremental costs 
that could be substantial. As an initial estimate, we pair the Belkin 
(2015) estimate of 0.012% of incremental health care costs with 
$3,931.3 billion in total health consumption expenditures in calendar 
year 2020.\716\ Combining these yields our upper-bound estimate of $472 
million in annual costs associated with additional coverage. As a 
lower-bound estimate, we adopt an assumption that these costs will be 
fully offset by reductions in spending on other medical care. This 
lower bound of $0 is broadly consistent with a cost-effectiveness 
analysis that includes the probability of negative incremental costs 
associated with coverage.\717\ For our primary estimate, we start with 
the midpoint of the lower-bound and upper-bound cost estimate of about 
$236 million annually. We reduce this figure by half to account for 
several factors, such as some covered entities already covering 
transition-related services under the baseline scenario, whether or not 
this is in response to an existing requirement. This results in a 
primary estimate of about $118 million per year in incremental annual 
costs associated with additional coverage under the proposed rule, with 
a full range of cost estimates including $0 million and $472 million.
---------------------------------------------------------------------------

    \716\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & 
Medicaid Servs., Table 1. National Health Expenditures; Aggregate 
and Per Capita Amounts, Annual Percent Change and Percent 
Distribution: Selected Calendar Years 1960-2020, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet (last modified 
Dec. 15, 2021, 4:06 p.m.).
    \717\ Padula, supra note 711, at 399 fig. 2.

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

[[Page 47904]]

c. Total Quantified Costs
    Table 4 below presents the total costs anticipated under the 
proposed rule for which estimates have been developed. For the purposes 
of this analysis, we assume that the regulatory requirements begin to 
take effect at the start of 2024. In the first year under the proposed 
rule, these costs include $774.5 million in training and $60.1 million 
to revise policies and procedures. For all years in the analysis, we 
estimate recurring costs of $39.2 million related to notices. We 
estimate a first-year cost of $26.3 million related to documentation, 
with ongoing costs in future years of $4.8 million. We also report a 
primary cost estimate of $117.9 million associated with expanded 
coverage of gender-transition-related care. The total costs in year 1 
amount to $1,018.1 million, with ongoing costs of $424.9 million in 
subsequent years. Table 3 reports these costs by year, with all 
estimates presented in millions of year-2020 dollars.

                                                     Table 3--Primary Estimate of Total Annual Costs
                                                               [$ millions, 2020 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                       Cost element                               2024               2025               2026               2027               2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training.................................................             $774.5             $258.2             $258.2             $258.2             $258.2
Policies and Procedures..................................               60.1                0.0                0.0                0.0                0.0
Notices..................................................               39.2               39.2               39.2               39.2               39.2
Documentation............................................               26.3                9.6                9.6                9.6                9.6
Expanded Coverage........................................              117.9              117.9              117.9              117.9              117.9
                                                          ----------------------------------------------------------------------------------------------
    Total Costs..........................................            1,018.1              424.9              424.9              424.9              424.9
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We also identify a cost related to covered entities submitting a 
request for an exemption based on Federal conscience or religious 
freedom laws. We model this potential cost associated with exemption 
requests as the time spent by covered entities to (a) assess the need 
for an exemption; (b) write the exemption request; and (c) submit the 
exemption request to OCR. As an initial calculation, we assume that 
this would involve two (2) employees spending two (2) hours each 
assessing the need for an exemption and one employee spending three (3) 
hours writing and submitting the exemption request to OCR. We further 
assume that legal personnel, including lawyers and legal assistants, 
would perform these functions. The mean hourly wage for these 
occupations is $63.02 per hour for each employee, which we double to 
account for overhead and other costs. We multiply these factors 
together and estimate the cost per exemption request of $882.28 ($63.02 
x 2 x 7).
    OCR receives an average of 428 Section 1557 complaints per year, 
covering all areas addressed under the statute and regulations. We 
estimate that about a quarter of these are sex discrimination 
complaints and anticipate that only a fraction of these correspond to 
religiously affiliated covered entities, and that not all of these 
complaints would relate to provision or coverage to which religiously 
affiliated covered entities would have a religious or conscience 
objection. As an initial calculation, we estimate that OCR would 
receive fewer than 27 exemption requests (428 x 0.25 x 0.5 x 0.5), and 
that these would result in costs to covered entities of $23,601 
(multiplying the previous product by $882.28). We include these costs 
in our assessment of the likely impacts of the proposed rule, but do 
not itemize these costs in Table 3 as they represent a rounding error 
compared to other costs we identify. We request public comment on the 
assumptions in this calculation.
    The proposed rule would also explicitly extend the requirements of 
Section 1557 and other civil rights statutes to entities that are 
enrolled in Medicare Part B. We are currently unable to quantify the 
number of covered entities that are enrolled in Part B but that receive 
no other forms of Federal financial assistance. The 2016 Rule discussed 
several of the challenges associated with estimating the number of 
these entities. For example, the 2016 Rule notes that, ``although we 
have data, by program, for the number of physicians receiving payment 
from each program, there is no single, unduplicated count of physicians 
across multiple programs.'' We tentatively adopt the finding of the 
2016 Rule that almost all practicing physicians were likely covered by 
the rule because they accept Federal financial assistance from sources 
other than Medicare Part B.\718\ We request comment and data on the 
number of entities who are enrolled in Medicare Part B but do not 
otherwise receive any form of Federal financial assistance.
---------------------------------------------------------------------------

    \718\ 81 FR 31375, 31445-46 (May 18, 2016).
---------------------------------------------------------------------------

2. Discussion of Benefits
    Quantifying benefits for this proposed rule presents significant 
challenges. One notable challenge relates to attribution: several 
sources of benefits discussed in the preambles of the 2016 and 2020 
Rules overlap with and may be attributable to prior existing civil 
rights regulation, to the ACA rather than the 2016 and 2020 rulemakings 
that implement Section 1557, or to nondiscrimination policies based on 
state law or institutional policies prohibiting discrimination 
generally.
    A second challenge relates to identifying a quantitative 
relationship between nondiscrimination policies and important outcomes 
such as improvements in public health outcomes. For example, we 
anticipate that this regulation would reduce the incidence of providers 
refusing to treat patients based on the patient's gender identity. This 
would result in fewer instances of delayed or denied care, which in 
turn would lead to reductions in mortality and morbidity risks. 
However, we are not able to estimate the changes in the magnitude of 
these discriminatory events that would be attributable to the proposed 
rule, and thus are unable to quantify or monetize these health 
improvements. Similarly, we anticipate that the proposed rule will 
result in other sources of benefits that we are unable to quantify. 
These include a reduction in suicidal ideation and attempts, 
improvements to mental health, reductions in substance use, and 
generally align with a discussion of the economic impacts of a 
California regulation relating to gender nondiscrimination in health 
insurance.\719\ In addition, the prohibition on discrimination through 
the use of clinical algorithms is also likely to have a direct benefit 
on the health of individuals who are suffering from delayed or denied 
medical care

[[Page 47905]]

due to discriminatory clinical algorithms, though we are unable to 
quantify this benefit.
---------------------------------------------------------------------------

    \719\ State of Cal., Dep't of Ins., supra note 703, at pp. 9-11.
---------------------------------------------------------------------------

    These challenges were not resolved in the RIAs associated with the 
2016 or 2020 Rules, which only qualitatively reported benefits. We 
request comments, including data and quantitative estimates of health 
and quality-of-life improvements attributable to nondiscrimination 
regulations, that could inform a quantitative analysis, should the 
Department finalize this proposed rule.
    In addition to these health improvements, we anticipate benefits to 
covered entities from additional regulatory clarity on how OCR will 
enforce the ACA's nondiscrimination protections, particularly in light 
of ongoing litigation related to the 2020 Rule, the Bostock decision, 
and the Department's Bostock Notification. The training provisions 
represent one mechanism by which the proposed rule would reduce 
discriminatory events. This would, in turn, reduce the number of 
enforcement actions, representing a potential cost-saving benefit for 
covered entities. We also anticipate benefits to covered entities from 
the establishment of a grievance process, which would reduce the number 
of complaints filed with OCR, though this may be offset somewhat from 
covered entities with fewer than 15 employees referring complaints to 
OCR in lieu of adopting their own grievance procedure.
    We also anticipate benefits to individuals from reduced obstacles 
to accessing health care, including fewer language barriers and a 
reduction in discriminatory behavior related to sexual orientation and 
gender identity. These benefits relate to individuals' ability to 
access care and the quality of care they receive. For example, the 
provisions related to language access for LEP individuals and 
accessibility for individuals with disabilities could reduce instances 
of negative outcomes, including death, due to a lack of understanding 
between patient and doctor or between patient and pharmacist, as well 
as lack of access to services. We also anticipate that the process by 
which individuals and recipients may seek an exemption based on Federal 
conscience and religious freedom laws will result in benefits from 
reduced litigation, which we do not capture in the cost analysis.
3. Analysis of Regulatory Alternatives to the Proposed Rule
    The Department considered various alternatives in the course of 
developing this regulation. The following are a representative sample 
of some of those various alternatives considered.
    The Department analyzed several regulatory alternatives to the 
proposed rule related to the notice requirements. The first alternative 
considered retaining the 2020 Rule repeal of the notices and taglines 
provisions. The Department considered concerns raised in response to 
the 2016 Rule notice and tagline requirements, as well as concerns 
raised in response to the removal of those requirements in the 2020 
Rule. Though the Department acknowledges the burden placed on covered 
entities through the 2016 Rule notice requirements, the Department 
believes the 2020 Rule did not adequately consider the confusion and 
uncertainty placed on individuals or the unnecessary ambiguity that 
covered entities face by the 2020 Rule's repeal of the notices and 
taglines provisions in their entirety. As described earlier, we 
estimate that these provisions under the proposed rule would cost 
covered entities, as an aggregate, $39.2 million for each year. While 
excluding the provisions relating to the notices would reduce the cost 
of the proposed rule by $39.2 million, the Department rejected this 
option because it believes that the proposed provisions strike an 
appropriate balance between providing greater access for beneficiaries 
and consumers, while maximizing efficiency and economics of scale for 
covered entities.
    The second alternative considered by the Department would require 
covered entities to provide notices only at their first encounter with 
a beneficiary. For this alternative, we adopt the quantity and cost 
estimates associated with eligibility and enrollment communication 
included in Table 3 above. Under our primary cost scenario, this policy 
alternative would result in annual costs of notices of $0.5 million, 
which is about $38.6 million lower than the proposed rule. The 
Department rejected this option however, because this policy 
alternative, while posing a significantly reduced burden on covered 
entities, would be too narrow and substantially reduce the information 
available to beneficiaries, likely resulting in beneficiaries not being 
aware of their civil rights, including whether they have experienced a 
prohibited discriminatory practice by a covered entity.
    The third alternative considered by the Department would require a 
more expansive notice provision, extending the requirements to include 
pharmacy-related notices. For this alternative, we adopt the 2020 RIA 
estimate of 2.9 billion annual pharmacy-related notices. This would 
result in $127.4 million in costs per year, or an increase of $88.2 
million compared to the proposed rule. While this alternative related 
to notices would increase the number of notices available to 
beneficiaries, and therefore increase beneficiaries' opportunity to 
receive information regarding nondiscrimination and civil rights 
protections, the Department believes this alternative would neither 
address nor remedy the burden placed on covered entities through the 
2016 Rule notice requirements. For this reason, the Department rejected 
this alternative.
    Finally, the Department also considered not including a process for 
covered entities to submit a request for a religious or conscience 
exemption. As described in the cost section, we estimate that this 
policy alternative would reduce the quantified costs by $23,601. 
Previous Departmental rulemakings have indicated that this policy 
alternative could also result in providers with religious and 
conscience objections leaving the profession, or covered entities 
exiting the market. We request comment on this potential impact, 
including any data or studies that provide quantitative evidence that 
the Department's May 10, 2021 Bostock Notification ``that the Office 
for Civil Rights will interpret and enforce Section 1557 and Title IX's 
prohibitions on discrimination based on sex to include: (1) 
discrimination on the basis of sexual orientation; and (2) 
discrimination on the basis of gender identity''--or subsequent actions 
consistent with the Bostock Notification--have resulted in impacts of 
this nature.
    We have not quantified the benefits associated with this 
information for the proposed rule or for these policy alternatives.
    Table 4 reports the total costs of these policy alternatives in 
present value and annualized terms, adopting a 3% and 7% discount rate. 
Table 5 reports the difference between the total cost of the 
alternatives compared to the provisions of the proposed rule, using the 
same accounting methods and discount rates. All estimates are presented 
in millions of year-2020 dollars, using 2024 as the base year for 
discounting.

[[Page 47906]]



                              Table 4--Total Cost of Policy Alternatives Considered
                                           [$ millions, 2020 dollars]
----------------------------------------------------------------------------------------------------------------
                                                  Present value                          Annualized
   Accounting method discount rate   ---------------------------------------------------------------------------
                                              3%                 7%                 3%                 7%
----------------------------------------------------------------------------------------------------------------
Proposed Rule.......................           $2,521.7           $2,296.4             $550.6             $560.1
Alternative 1: No Notice Provision..            2,342.2            2,135.8              511.4              520.9
Alternative 2: Single Notice                    2,344.7            2,138.0              512.0              521.4
 Provision..........................
Alternative 3: Pharmacy-Related                 2,925.9            2,658.3              638.9              648.3
 Notices............................
----------------------------------------------------------------------------------------------------------------


                              Table 5--Comparison of Alternatives to Proposed Rule
                                           [$ millions, 2020 dollars]
----------------------------------------------------------------------------------------------------------------
                                                  Present Value                          Annualized
   Accounting method discount rate   ---------------------------------------------------------------------------
                                              3%                 7%                 3%                 7%
----------------------------------------------------------------------------------------------------------------
Alternative 1: No Notice Provision..            -$179.5            -$160.7             -$39.2             -$39.2
Alternative 2: Single Notice                     -177.0             -158.5              -38.6              -38.6
 Provision..........................
Alternative 3: Pharmacy-related                   404.1              361.8               88.2               88.2
 Notices............................
----------------------------------------------------------------------------------------------------------------

    The Department also considered whether to require covered entities 
to collect the self-identified race, ethnicity, primary language 
(spoken and written), sex, age, and disability status data for 
participants, beneficiaries, enrollees, and applicants in any health 
program or activity. The Department believes, however, that our current 
authorities under Section 1557, Title VI, Section 504, Title IX, and 
the Age Act already provide us sufficient ability to collect these 
data.

B. Regulatory Flexibility Act--Initial Small Entity Analysis

    The Department has examined the economic implications of this 
proposed rule as required by the Regulatory Flexibility Act. This 
analysis, as well as other sections in this Regulatory Impact Analysis, 
serves as the Initial Regulatory Flexibility Analysis, as required 
under the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
    The U.S. Small Business Administration (SBA) maintains a Table of 
Small Business Size Standards Matched to North American Industry 
Classification System Codes (NAICS).\720\ We replicate the SBA's 
description of this table:
---------------------------------------------------------------------------

    \720\ U.S. Small Bus. Admin., Table of Size Standards, (last 
updated May 2, 2022), https://www.sba.gov/document/support--table-size-standards.

    ``This table lists small business size standards matched to 
industries described in the North American Industry Classification 
System (NAICS), as modified by the Office of Management and Budget, 
effective January 1, 2017. The latest NAICS codes are referred to as 
NAICS 2017.
    The size standards are for the most part expressed in either 
millions of dollars (those preceded by ``$'') or number of employees 
(those without the ``$''). A size standard is the largest that a 
concern can be and still qualify as a small business for Federal 
Government programs. For the most part, size standards are the 
average annual receipts or the average employment of a firm.''

    This initial small entity analysis adopts a finding from the 2016 
Final Rule that almost all businesses under the scope of the proposed 
rule are small businesses. In that analysis, the total small entities 
numbered 254,998, which accounts for about 93% of the 275,002 covered 
entities under the proposed rule. The covered entities not considered 
small businesses include about 10% of physician practices that exceed 
the SBA size standard for physicians (excluding mental health 
specialists) (North American Industry Classification System code 
62111); about 12% of pharmacies that exceed the SBA size standard for 
pharmacy and drug store firms (North American Industry Classification 
System code 44611); health insurance issuers; and local government 
entities.
2. Description of the Potential Impacts of the Rule on Small Entities
    The Department generally considers a rule to have a significant 
impact on a substantial number of small entities if it has at least a 
3% impact on revenue on at least 5% of small entities. We performed a 
threshold analysis to determine whether the proposed rule is likely to 
exceed these thresholds. As described earlier in this analysis, we 
estimate the total annualized costs of the proposed rule would be about 
$551 million. Dividing these total costs by the 254,998 small entities 
gives a cost per entity of $2,159. This cost estimate would only exceed 
the 3% ``significant impact'' threshold on revenue for any covered 
small businesses with revenue below $71,978. We tentatively conclude 
that very few small businesses covered by the proposed rule have 
revenue below $71,978, and that this number is very likely to be 
smaller than the 5% ``substantial number'' threshold.
    As an additional consideration, we note that the costs of the 
proposed rule are mostly proportional to the size of the covered 
entity. For example, the costs associated with training, which account 
for more than 70% of the total costs of the proposed rule, are 
proportional to the number of employees receiving training. In the main 
analysis, we estimate an incremental impact of one (1) hour per 
employee trained. The opportunity cost of training each employee 
represents 0.05% of a full-time employee's annual labor productivity, 
assuming a full-time employee works 2,087 hours per year. This finding, 
that the cost of training represents 0.05% of the share of employees 
receiving training, is constant across firm size.
    Because the costs of the proposed rule are small relative to the 
revenue of covered entities, including covered small entities, and 
because even the smallest affected entities would be unlikely to face a 
significant impact, we propose to certify that the proposed rule will 
not have a significant economic impact on a substantial number of small 
entities.

C. Executive Order 13132: Federalism

    As required by E.O. 13132 on Federalism, the Department has 
examined the effects of provisions in the

[[Page 47907]]

proposed regulation on the relationship between the Federal Government 
and the States. The Department has concluded that the proposed 
regulation has Federalism implications but preempts State law only 
where the exercise of State authority directly conflicts with the 
exercise of Federal authority under the Federal statute.
    The proposed regulation attempts to balance State autonomy with the 
necessity to create a Federal benchmark that will provide a uniform 
level of nondiscrimination protection across the country. The proposed 
regulation restricts regulatory preemption of State law to the minimum 
level necessary to achieve the objectives of the underlying Federal 
statute, Section 1557 of the ACA.
    It is recognized that the States generally have laws that relate to 
nondiscrimination against individuals on a variety of bases. State laws 
continue to be enforceable, unless they prevent application of the 
proposed rule. The proposed rule explicitly provides that it is not to 
be construed to supersede State or local laws that provide additional 
protections against discrimination on any basis articulated under the 
regulation. Provisions of State law relating to nondiscrimination that 
are ``more stringent'' than the proposed Federal regulatory 
requirements or implementation specifications will continue to be 
enforceable.
    Section 3(b) of E.O. 13132 recognizes that national action limiting 
the policymaking discretion of States will be imposed only where there 
is constitutional and statutory authority for the action and the 
national activity is appropriate in light of the presence of a problem 
of national significance. Discrimination issues in relation to health 
care are of national concern by virtue of the scope of interstate 
health commerce. The ACA's provisions reflect this position.
    Section 3(d)(2) of E.O. 13132 requires that where possible, the 
Federal Government defer to the States to establish standards. Title I 
of the ACA authorized the Secretary to promulgate regulations to 
implement Section 1557, and we have done so accordingly.
    Section 4(a) of E.O. 13132 expressly contemplates preemption when 
there is a conflict between exercising State and Federal authority 
under a Federal statute. Section 4(b) of the Executive Order authorizes 
preemption of State law in the Federal rule making context when ``the 
exercise of State authority directly conflicts with the exercise of 
Federal authority under the Federal statute.'' The approach in this 
regulation is consistent with these standards in the Executive Order in 
superseding State authority only when such authority is inconsistent 
with standards established pursuant to the grant of Federal authority 
under the statute.
    Section 6(b) of E.O. 13132 includes some qualitative discussion of 
substantial direct compliance costs that State and local governments 
would incur as a result of a proposed regulation. We have determined 
that the costs of the proposed rule would not impose substantial direct 
compliance costs on State or local governments. We have considered the 
cost burden that this proposed rule would impose on State and local 
health care and benefit programs, and estimate State and local 
government costs will be in the order of $5.7 million in the first two 
years of implementation. The $1.9 million represents the sum of the 
costs of training State workers and enforcement costs attributable to 
State agencies analyzed above.

D. Executive Order 12250 on Leadership and Coordination of 
Nondiscrimination Laws

    Pursuant to E.O. 12250, the Attorney General has the responsibility 
to ``review . . . proposed rules . . . of the Executive agencies'' 
implementing nondiscrimination statutes such as Section 1557 ``in order 
to identify those which are inadequate, unclear or unnecessarily 
inconsistent.'' \721\ The Attorney General has delegated that function 
to the Assistant Attorney General for the Civil Rights Division for 
purposes of reviewing and approving proposed rules, 28 CFR 0.51, and 
the Assistant Attorney General has reviewed and approved this proposed 
rule.
---------------------------------------------------------------------------

    \721\ E.O. 12250, sec. 1-202; 45 FR 72995 (Nov. 2, 1980).
---------------------------------------------------------------------------

E. Paperwork Reduction Act

    This proposed rule contains information collection requirements 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA).\722\ Under the PRA, 
agencies are required to submit to OMB for review and approval any 
reporting or record-keeping requirements inherent in a proposed or 
final rule and are required to publish such proposed requirements for 
public comment. The PRA requires agencies to provide a 60-day notice in 
the Federal Register and solicit public comment on a proposed 
collection of information before it is submitted to OMB for review and 
approval. Section 3506(c)(2)(A) of the PRA requires that the Department 
solicit comment on the following issues:
---------------------------------------------------------------------------

    \722\ 44 U.S.C. 3501 et seq.
---------------------------------------------------------------------------

    1. Whether the information collection is necessary and useful to 
carry out the proper functions of the agency;
    2. The accuracy of the agency's estimate of the information 
collection burden;
    3. The quality, utility, and clarity of the information to be 
collected; and
    4. Recommendations to minimize the information collection burden on 
the affected public, including automated collection techniques.
    The PRA requires consideration of the time, effort, and financial 
resources necessary to meet the information collection requirements 
referenced in this section. The Department invites public comment on 
its assumptions as they relate to the PRA requirements summarized in 
this section and explicitly invites comment from potential respondents 
regarding the burden estimate we ascribe to these requirements, 
including a discussion of respondents' basis for their computation.
    The collections of information proposed by this Notice of Proposed 
Rulemaking relate to Sec.  92.5 (Assurances required); Sec.  92.7 
(Designation and responsibilities of a Section 1557 Coordinator); Sec.  
92.8 (Section 1557 Policies and Procedures); Sec.  92.9 (Training); 
Sec.  92.10 (Notice of nondiscrimination); and Sec.  92.11 (Notice of 
availability of language assistance services and auxiliary aids and 
services). Respondents to this proposed information collection would 
include a variety of covered entities with a health program or activity 
including hospitals, ambulatory surgical centers, skilled nursing 
facilities, and physicians' offices. For a more detailed discussion 
concerning the potential costs implications related to these proposed 
collections of information, please see the Preliminary Economic 
Analysis of Impacts directly below.
    Proposed Sec.  92.5 retains the assurances obligation from the 2016 
and 2020 Rules for covered entities to submit an assurance of 
compliance to the Department. OCR has previously obtained PRA approval 
(OMB control # 0945-0008) for this reporting requirement via an updated 
HHS Form 690 (Consolidated Civil Rights Assurance Form), separate from 
this rulemaking. The requirement to sign and submit an assurance of 
compliance currently exists under Section 1557 and other civil rights 
regulations (Title VI, Section 504, Title IX, and the Age Act). Since 
the Department provides an online portal through which covered entities 
submit an attestation of

[[Page 47908]]

Assurance of Compliance, the Department has determined that this 
requirement imposes no additional reporting or recordkeeping 
requirements under the PRA.
    Proposed Sec.  92.7 requires covered entities with 15 or more 
employees to designate a Section 1557 Coordinator to coordinate their 
efforts to comply with and carry out their responsibilities under 
Section 1557. The burden to coordinate efforts to comply with and carry 
out the responsibilities under Section 1557 is estimated at an 
annualized burden of 10 hours per covered entity to store complaints 
and the associated records required under proposed Sec.  92.8(c)(2) 
each year. We assume that administrative or clerical support personnel 
would perform these functions. The mean hourly wage for this occupation 
is $17.38 per hour. The Department estimates the number of covered 
entities with more than 15 employees to be approximately 15% or 41,250. 
We estimate the costs of retaining records related to grievances filed 
at all covered entities would be $14.3 million annually ($17.38 x 2 x 
10 x 41,250). This estimation approach will overstate the costs if many 
covered entities already retain complaint information.
    The burden for documenting employee training as required under 
proposed Sec.  92.9(c) is the cost of covered entity staff time to (a) 
create training attendance forms; and (b) store the training sign-up 
sheet. The labor cost would include one (1) employee spending 15 
minutes (0.25 hours) to create the sign-up sheet during the first year 
and one (1) employee spending one (1) hour collecting and storing the 
attendance forms during the first year and subsequent years. We 
estimate that administrative or clerical support personnel would 
perform these functions. The mean hourly wage for this occupation is 
$17.38 per hour. The labor cost is $6.0 million in the first year 
(($17.38 x 1.25) x 275,002 covered entities). We estimate that the cost 
in subsequent years would be $4.8 million, which would represent an 
annual allotment of one (1) hour (($17.38 x 1) x 275,002 covered 
entities).
    Proposed Sec.  92.10 and Sec.  92.11 require covered entities to 
notify the public of their nondiscrimination requirements, as well as 
the availability of language assistance services and auxiliary aids and 
services.
    Proposed Sec.  92.10 requires covered entities to provide a notice 
of nondiscrimination relating to its health programs or activities, to 
participants, beneficiaries, enrollees, and applicants of its health 
programs and activities, and members of the public. To minimize burden 
on covered entities, the provision proposes a covered entity may 
combine the content of the notice required by this section with the 
notice required by Title VI, Section 504, Title IX, and the Age Act 
implementing regulations.
    Proposed Sec.  92.11 requires covered entities to notify the public 
of their nondiscrimination requirements, as well as availability of 
language assistance services and auxiliary aids and services. A covered 
entity must provide a notice that, at minimum, states that the covered 
entity provides language assistance services and auxiliary aids and 
services free of charge in its health programs and activities, in 
compliance with Section 1557. This notice must be provided to 
participants, beneficiaries, enrollees, and applicants of the covered 
entity's health program or activity, and members of the public. The 
notice must be provided in English and at least the most common 15 
languages spoken by LEP individuals of the relevant state or states and 
must be provided in alternate formats for individuals with disabilities 
who require auxiliary aids and services to ensure effective 
communication.
    Both types of notices are required (1) on an annual basis; (2) upon 
request; (3) at a conspicuous location on the covered entity's health 
program or activity website; and (4) in clear and conspicuous physical 
locations where the health program or activity interacts with the 
public.
    The Department estimates the burden for responding to the proposed 
notice requirement would be 34 minutes and that administrative or 
clerical support personnel would perform these functions. Because it is 
difficult to determine the exact number of communications which would 
be required to contain the notices anticipated under the proposed rule, 
our cost estimates reflect a wide range of uncertainty in the cost. The 
Department estimates an adjusted annual primary costs total of $4.5 
million, with a range of costs between $2.7 million and $25.0 million. 
These costs would occur in each year of the time horizon of the 
analysis.

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

    \723\ The figures in this column are averages based on a range. 
Small entities may require fewer hours to conduct certain compliance 
activities, while large entities may require more hours than those 
provided here due to their size and complexity.
    \724\ Covered entities with 15 or more employees would be 
required to coordinate the retention of grievance complaints for no 
less than three years. We have estimated that this provision would 
apply to approximately 41,250 covered entities. All covered entities 
would be required to document employee training on Section 1557. We 
estimated that this would apply to approximately 275,002 covered 
entities.
    \725\ We have estimated that covered entities with 15 or more 
employees would spend approximately 10 hours on efforts to 
coordinate their compliance efforts under Section 1557 as required 
under Sec.  92.7. We estimate that all covered entities would spend 
approximately 1.25 hours documenting employee training as required 
under Sec.  92.9.
    \726\ Because it is difficult to determine the exact number of 
communications which would be required to contain the notices 
anticipated under the proposed rule, our number of responses per 
respondent estimate reflects this uncertainty. The Department 
invites potential respondents to comment on its assumption regarding 
number of responses per respondent and the ultimate burden estimate 
we ascribe to this requirement, including a discussion of 
respondents' basis for their computation.

                    Table 1--Proposed Annual Burden of Response in Year One/Subsequent Years Following Publication of the Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                          Number of          Number of         Total        burden  per    Total annual
           Regulation  burden                Type of respondent          respondents       responses per     responses         hours          burden
                                                                                            respondent                       response      (hours) \723\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   92.7 Coordination Efforts.......  Covered entities with 15   \724\ 41,250/275,002               1         316,252   \725\ 10/1.25         756,252
                                          or more employees/all
                                          covered entities.
Sec.   92.10 & Sec.   92.11 Notice.....  All covered entities.....               275,002         \726\ 1         275,002           34/60          93,501
                                                                   -------------------------------------------------------------------------------------
    Total Annual Burden Hours..........  .........................  ....................  ..............  ..............  ..............         849,753
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The figures in this column are averages based on a range. Small entities may require fewer hours to conduct certain compliance activities, while large
  entities may require more hours than those provided here due to their size and complexity.
** We monetize the time spent on revising policies and procedures, depending on the extent of the revisions. For the 137,501 covered entities with less
  extensive revisions, we estimate two (2) total hours spent on revisions per entity. For the 137,501 covered entities with more extensive revisions, we
  estimate four (4) total hours spent on revision per entity.

[[Page 47909]]

 
*** Because it is difficult to determine the exact number of communications which would be required to contain the notices anticipated under the
  proposed rule, our number of responses per respondent estimate reflects this uncertainty. The Department invites potential respondents to comment on
  its assumption regarding a number of responses per respondent and the ultimate burden estimate we ascribe to this requirement, including a discussion
  of respondents' basis for their computation.

VII. Request for Comment

    The Department seeks comment on all issues raised by the proposed 
regulation. Specifically, in addition to issues on which it has already 
requested comments above, the Department requests comment on:
     The financial impact of the proposed rule on the health 
care sector, with any detailed supporting information, facts, surveys, 
audits, or reports;
     Whether the application of this rule to health programs 
and activities that receive Federal funding, to health programs and 
activities of executive agencies, and to all programs and activities of 
executive agencies should be considered in a different manner;
     Whether, and if so how, the proposed rule addresses 
clarity and confusion over compliance requirements and rights of people 
to be free from discrimination on protected bases;
     Whether covered entities that employ fewer than 15 people 
should be required to have a Section 1557 Coordinator and grievance 
procedures, and any benefits and burdens associated with such a 
requirement;
     Whether, and if so how, new and developing technologies 
can assist covered entities with their compliance obligations and 
enhance access to quality health care;
     The costs to provide the notice of nondiscrimination and 
the Notice of Availability and the impact of such notices on the 
utilization of language assistance services for LEP individuals and 
auxiliary aids and services for individuals with disabilities with any 
detailed supporting information, facts, surveys, audits, or reports;
     Whether the list of communications that require a Notice 
of Availability captures those most critical for LEP individuals and 
individuals with disabilities, and any detailed supporting information, 
facts, surveys, audits, or reports pertaining to the benefit of such 
notices or the related cost of their inclusion in the listed 
communications;
     Whether standards set pursuant to Section 510 of the 
Rehabilitation Act on ensuring the availability of accessible medical 
diagnostic equipment, should be incorporated as an enforceable standard 
for covered entities into the proposed rule for purposes of Section 
1557;
     How best to address challenges accessing accessible 
medical diagnostic equipment and whether lack of access to such 
equipment constitutes discriminatory benefit design or network 
inadequacy;
     Whether Section 1557 should include a provision requiring 
covered entities to comply with specific accessibility standards for 
web content such as Section 508 standards, the WCAG 2.0 standards, the 
WCAG 2.1 standards, or other standards that provide equal or greater 
accessibility to individuals with disabilities. Additionally, OCR seeks 
comments on whether to adopt a safe harbor provision under which 
covered entities that are in compliance with established specific 
accessibility standards are deemed in compliance with proposed Sec.  
92.204; whether OCR should require covered entities to comply with the 
most recent edition of a published standard; and the timeline necessary 
for covered entities to come into compliance with a new standard.
     What steps the Department can take to assist covered 
entities in meeting their language access and effective communication 
responsibilities, such that these services are provided in the most 
efficient and effective manner for participants, beneficiaries, 
enrollees, and applicants of covered health programs and activities.
     Unaddressed discrimination on the basis of race, color, 
national origin (including limited English proficiency and primary 
language), sex (including pregnancy, sexual orientation, gender 
identity, and sex characteristics), age, and disability as applied to 
State and Federally-facilitated Exchanges, with any detailed supporting 
information, facts, surveys, audits, or reports; and
     Whether covered entities seek guidance on best practices 
for compliance with Section 1557, and on what topics.

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 457

    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, 
Individuals with disabilities, Medicare, Medicaid, National origin, 
Nondiscrimination, Religious discrimination, Reporting and 
recordkeeping requirements, Sex discrimination.

45 CFR Part 80

    Administrative practice and procedure, Civil rights, 
Discrimination, Medicare, Nondiscrimination.

45 CFR Part 84

    Administrative practice and procedure, Civil rights, 
Discrimination, Individuals with disabilities, Medicare, 
Nondiscrimination.

45 CFR Part 86

    Administrative practice and procedure, Civil rights, 
Discrimination, Education, Medicare, Nondiscrimination, Sex 
discrimination.

45 CFR Part 91

    Administrative practice and procedure, Civil rights, 
Discrimination, Elderly, Medicare, Nondiscrimination.

45 CFR Part 92

    Administrative practice and procedure, Civil rights, 
Discrimination, Elderly, Health care, Health facilities, Health 
insurance, Health programs and activities, Individuals with 
disabilities, Medicare, Nondiscrimination, Reporting and recordkeeping 
requirements, Sex discrimination.

45 CFR Part 147

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

45 CFR Part 155

    Administrative practice and procedure, Advertising, Aged, Brokers, 
Citizenship and naturalization, Civil rights, Conflict of interests, 
Consumer protection, Grant programs-health, Grants administration, 
Health care, Health insurance, Health maintenance organizations (HMO), 
Health records,

[[Page 47910]]

Hospitals, Indians, Individuals with disabilities, Intergovernmental 
relations, Loan programs-health, Medicaid, Organization and functions 
(Government agencies), Public assistance programs, Reporting and 
recordkeeping requirements, Sex discrimination, State and local 
governments, Taxes, Technical assistance, Women, Youth.

45 CFR Part 156

    Administrative practice and procedure, Advertising, Advisory 
committees, Brokers, Conflict of interests, Consumer protection, Grant 
programs-health, Grants administration, Health care, Health insurance, 
Health maintenance organization (HMO), Health records, Hospitals, 
Indians, Individuals with disabilities, Loan programs-health, Medicaid, 
Organization and functions (Government agencies), Public assistance 
programs, Reporting and recordkeeping requirements, 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 proposes to amend 42 CFR parts 438, 440, 457, and 
460 and 45 CFR parts 80, 84, 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 (including sexual orientation and gender 
identity), or disability and will not use any policy or practice that 
has the effect of discriminating on the basis of race, color, national 
origin, sex (sexual orientation and gender identity), 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 (including sexual 
orientation and gender identity).
* * * * *

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 (including 
sexual orientation and gender identity). These methods must ensure that 
beneficiaries have access to covered services that are delivered in a 
manner that meets their individualized needs.

PART 457--ALLOTMENTS AND GRANTS TO STATES

0
6. The authority citation for part 457 continues to read as follows:

    Authority: Section 1102 of the Social Security Act (42 U.S.C. 
1302).

0
7. Section 457.495 is amended by adding paragraph (e) to read as 
follows:


Sec.  457.495  State assurance of access to care and procedures to 
assure quality and appropriateness of care.

* * * * *
    (e) Access to and delivery of services in a culturally competent 
manner to all beneficiaries, as described in 42 CFR 440.262.

PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

0
8. 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
9. 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 (including sexual orientation 
and gender identity), age, mental or physical disability, or source of 
payment.
* * * * *
0
10. Amend Sec.  460.112 by revising paragraph (a) introductory text 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 
(including sexual orientation and gender identity), age, mental or 
physical disability, or source of payment. Specifically, each 
participant has the right to the following:
* * * * *

Title 45--Public Health

PART 80--NONDISCRIMINATION UNDER PROGRAMS RECEIVING FEDERAL 
ASSISTANCE THROUGH THE DEPARTMENT OF HEALTH AND HUMAN SERVICES 
EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964

0
11. The authority citation for part 80 continues to read as follows:

    Authority: Sec. 602, 78 Stat. 252; 42 U.S.C. 2000d-1.

0
12. Amend part 1 of appendix A to part 80 by adding paragraph 155 to 
read as follows:

Appendix A to Part 80--Federal Financial Assistance to Which These 
Regulations Apply

    Part 1 * * *

0
155. Supplementary medical insurance benefits for the aged (Title 
XVIII, Part B, Social Security Act, 42 U.S.C. 1395j-1395w-6).
* * * * *

PART 84--NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR 
ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE

0
13. The authority citation for part 84 continues to read as follows:

    Authority: 20 U.S.C. 1405; 29 U.S.C. 794; 42 U.S.C. 290dd-2; 21 
U.S.C. 1174.

Appendix A to Part 84 [Amended]

0
14. Amend appendix A to part 84 under subpart a by removing the third

[[Page 47911]]

paragraph in ``2. Federal financial assistance''.
0
15. Revise part 92 to read as follows:

PART 92--NONDISCRIMINATION IN HEALTH PROGRAMS OR ACTIVITIES

Subpart A--General Provisions
Sec.
92.1 Purpose and applicability date.
92.2 Application.
92.3 Relationship to other laws.
92.4 Definitions.
92.5 Assurances required.
92.6 Remedial action and voluntary action.
92.7 Designation and responsibilities of a Section 1557 Coordinator.
92.8 Policies and procedures.
92.9 Training.
92.10 Notice of nondiscrimination.
92.11 Notice of availability of language assistance services and 
auxiliary aids and services.
Subpart B--Nondiscrimination Provisions
92.101 Discrimination prohibited.
Subpart C--Specific Applications to Health Programs and Activities.
92.201 Meaningful access for limited English proficient individuals.
92.202 Effective communication for individuals with disabilities.
92.203 Accessibility for buildings and facilities.
92.204 Accessibility of information and communication technology for 
individuals with disabilities.
92.205 Requirement to make reasonable modifications.
92.206 Equal program access on the basis of sex.
92.207 Nondiscrimination in health insurance and other health-
related coverage.
92.208 Prohibition on sex discrimination related to marital, 
parental, or family status.
92.209 Nondiscrimination on the basis of association.
92.210 Nondiscrimination in the use of clinical algorithms in 
decision-making.
92.211 Nondiscrimination in the delivery of health programs and 
activities through telehealth services.
Subpart D--Procedures
92.301 Enforcement mechanisms.
92.302 Notification of views regarding application of Federal 
conscience and religious freedom laws.
92.303 Procedures for health programs and activities conducted by 
recipients and State Exchanges.
92.304 Procedures for health programs and activities administered by 
the Department.

    Authority: 42 U.S.C. 18116

Subpart A--General Provisions

Sec.  92.1 Purpose and applicability date.
    (a) Purpose. The purpose of this part is to implement Section 1557 
of the Patient Protection and Affordable Care Act (ACA) (42 U.S.C. 
18116), which prohibits discrimination on the basis of race, color, 
national origin, sex, age, and disability in certain health programs 
and activities. Section 1557 provides that, except as otherwise 
provided in Title I of the ACA, an individual shall not, on the grounds 
prohibited 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, 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, or under any program or activity 
that is administered by an Executive Agency or any entity established 
under Title I of the ACA. This part applies to health programs or 
activities administered by recipients of Federal financial assistance 
from the Department, Department-administered health programs or 
activities, and Title I entities that administer health programs or 
activities.
    (b) Applicability date. The regulations in this part are applicable 
beginning [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE], 
except to the extent that provisions of this part require changes to 
health insurance or group health plan benefit design (including covered 
benefits, benefit limitations or restrictions, and cost-sharing 
mechanisms, such as coinsurance, copayments, and deductibles); such 
provisions, as they apply to health insurance or group health plan 
benefit design, have an applicability date of the first day of the 
first plan year (in the individual market, policy year) beginning on or 
after [DATE ONE YEAR AFTER EFFECTIVE DATE OF FINAL RULE].


Sec.  92.2  Application.

    (a) Except as otherwise provided in this part, this part shall 
apply to:
    (1) Every health program or activity, any part of which receives 
Federal financial assistance, directly or indirectly, from the 
Department;
    (2) Every health program or activity administered by the 
Department; and
    (3) Every program or activity administered by a Title I entity.
    (b) The provisions of this part shall not apply to any employer 
with regard to its employment practices, including the provision of 
employee health benefits.
    (c) Any provision of this part held to be invalid or unenforceable 
by its terms, or as applied to any person or circumstance, 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.  92.3  Relationship to other laws.

    (a) Neither section 1557 nor this part shall be construed to apply 
a lesser standard for the protection of individuals from discrimination 
than the standards applied under Title VI of the Civil Rights Act of 
1964, Title IX of the Education Amendments of 1972, Section 504 of the 
Rehabilitation Act of 1973, the Age Discrimination Act of 1975, or the 
regulations issued pursuant to those laws.
    (b) Nothing in this part shall be construed to invalidate or limit 
the rights, remedies, procedures, or legal standards available under 
Title VI of the Civil Rights Act of 1964, Title VII of the Civil Rights 
Act of 1964, Title IX of the Education Amendments of 1972, Section 504 
of the Rehabilitation Act of 1973, or the Age Discrimination Act of 
1975.
    (c) Nothing in this part shall be construed to invalidate or limit 
the rights, remedies, procedures, or legal standards available to 
individuals under Federal conscience or religious freedom laws.


Sec.  92.4  Definitions.

    As used in this part, the term--
    1991 Standards means the 1991 ADA Standards for Accessible Design, 
published at Appendix A to 28 CFR part 36 on July 26, 1991, and 
republished as Appendix D to 28 CFR part 36 on September 15, 2010.
    2010 Standards means the 2010 ADA Standards for Accessible Design, 
as defined at 28 CFR 35.104.
    ACA means the Patient Protection and Affordable Care Act (Pub. L. 
111-148, 124 Stat. 119 (2010) as amended by the Health Care and 
Education Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat. 1029) 
(codified in scattered sections of U.S.C.)).
    ADA means the Americans with Disabilities Act of 1990 (42 U.S.C. 
12101 et seq.), as amended.
    Age means how old a person is, or the number of elapsed years from 
the date of a person's birth.
    Age Act means the Age Discrimination Act of 1975 (42 U.S.C. 6101 et 
seq.), as amended.
    Applicant means a person who applies to participate in a health 
program or activity.
    Auxiliary aids and services include, for example:
    (1) Qualified interpreters on-site or through video remote 
interpreting (VRI)

[[Page 47912]]

services, as defined in 28 CFR 35.104 and 36.303(b); 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 
telecommunications products and systems, including text telephones 
(TTYs), videophones, and captioned telephones, or equally effective 
telecommunications devices; videotext displays; accessible information 
and communication technology (ICT); or other effective methods of 
making aurally delivered information available to persons who are deaf 
or hard of hearing;
    (2) Qualified readers; taped texts; audio recordings; Braille 
materials and displays; screen reader software; magnification software; 
optical readers; secondary auditory programs (SAP); large print 
materials; accessible information and communication technology; or 
other effective methods of making visually delivered materials 
available to persons who are blind or have low vision;
    (3) Acquisition or modification of equipment and devices; and
    (4) Other similar services and actions.
    Companion means a family member, friend, or associate of an 
individual seeking access to a service, program or activity of a 
covered entity, who along with such individual, is an appropriate 
person with whom a covered entity should communicate.
    Covered entity means:
    (1) A recipient of Federal financial assistance;
    (2) The Department; and
    (3) An entity established under Title I of the ACA.
    Department means the U.S. Department of Health and Human Services.
    Director means the Director of the Office for Civil Rights (OCR) of 
the Department, or their designee(s).
    Disability means, with respect to a person, a physical or mental 
impairment that substantially limits one or more major life activities 
of such person; 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 ADA, 42 U.S.C. 12102, as amended and 
adopted at 28 CFR 35.108.
    Exchange means the same as ``Exchange'' defined in 45 CFR 155.20.
    Federal financial assistance. (1) Federal financial assistance 
means any grant, loan, credit, subsidy, contract (other than a 
procurement contract but including a contract of insurance), or any 
other arrangement by which the Federal Government, directly or 
indirectly, provides assistance or otherwise makes assistance available 
in the form of:
    (i) Funds;
    (ii) Services of Federal personnel; or
    (iii) Real or personal property or any interest in or use of such 
property, including:
    (A) Transfers or leases of such property for less than fair market 
value or for reduced consideration; and
    (B) Proceeds from a subsequent transfer or lease of such property 
if the Federal share of its fair market value is not returned to the 
Federal Government.
    (2) Federal financial assistance the Department provides or 
otherwise makes available includes Federal financial assistance that 
the Department plays a role in providing or administering, including 
advance payments of the premium tax credit and cost-sharing reduction 
payments under Title I of the ACA, as well as payments, subsidies, or 
other funds extended by the Department to any entity providing health 
insurance coverage for payment to or on behalf of a person obtaining 
health insurance coverage from that entity or extended by the 
Department directly to such person for payment to any entity providing 
health insurance coverage.
    Federally-facilitated Exchange means the same as ``Federally-
facilitated Exchange'' defined in 45 CFR 155.20.
    Health program or activity means:
    (1) Any project, enterprise, venture, or undertaking to
    (i) Provide or administer health-related services, health insurance 
coverage, or other health-related coverage;
    (ii) Provide assistance to persons in obtaining health-related 
services, health insurance coverage, or other health-related coverage;
    (iii) Provide clinical, pharmaceutical, or medical care;
    (iv) Engage in health research; or
    (v) Provide health education for health care professionals or 
others;
    (2) All of the operations of any entity principally engaged in the 
provision or administration of any health projects, enterprises, 
ventures, or undertakings described in paragraph (1) of this 
definition, including, but not limited to, a State or local health 
agency, hospital, health clinic, health insurance issuer, physician's 
practice, pharmacy, community-based health care provider, nursing 
facility, residential or community-based treatment facility, or other 
similar entity or combination thereof.
    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, but are not limited to: computers and peripheral equipment; 
information kiosks and transaction machines; telecommunications 
equipment; telehealth interfaces or applications; customer premises 
equipment; multifunction office machines; software; mobile 
applications; websites; videos; and electronic documents.
    Language assistance services may include, but are not limited to:
    (1) Oral language assistance, including interpretation in non-
English languages provided in-person or remotely by a qualified 
interpreter for a limited English proficient individual, and the use of 
qualified bilingual or multilingual staff to communicate directly with 
limited English proficient individuals;
    (2) Written translation, performed by a qualified translator, of 
written content in paper or electronic form into or from languages 
other than English; and
    (3) Written notice of availability of language assistance services.
    Limited English proficient individual means an individual whose 
primary language for communication is not English and who has a limited 
ability to read, write, speak, or understand English. A limited English 
proficient individual may be competent in English for certain types of 
communication (e.g., speaking or understanding), but still be limited 
English proficient for other purposes (e.g., reading or writing).
    Machine translation means automated translations, without the 
assistance of or review by a qualified human translator, that is text-
based and provides instant translations between various languages, 
sometimes with an option for audio input or output.
    National origin includes, but is not limited to, a person's, or 
their ancestor's, place of origin (such as country or world region) or 
a person's manifestation of the physical, cultural, or linguistic 
characteristics of a national origin group.
    OCR means the Office for Civil Rights of the Department.
    Qualified bilingual/multilingual staff means a member of a covered 
entity's

[[Page 47913]]

workforce who is designated by the covered entity to provide in-
language oral language assistance as part of the person's current, 
assigned job responsibilities and who has demonstrated to the covered 
entity that they are:
    (1) Proficient in speaking and understanding both spoken English 
and at least one other spoken language, including any necessary 
specialized vocabulary, terminology and phraseology; and
    (2) Able to effectively, accurately, and impartially communicate 
directly with limited English proficient individuals in their primary 
languages.
    Qualified individual with a disability means an individual with a 
disability who, with or without reasonable modifications to rules, 
policies, or practices, the removal of architectural, communication, or 
transportation barriers, or the provision of auxiliary aids and 
services, meets the essential eligibility requirements for the receipt 
of services or the participation in programs or activities provided by 
the covered entity.
    Qualified interpreter for an individual with a disability means an 
interpreter who, via a video remote interpreting service (VRI) or an 
on-site appearance, is able to interpret effectively, accurately, and 
impartially, both receptively and expressively, using any necessary 
specialized vocabulary. Qualified interpreters include, for example, 
sign language interpreters, oral transliterators, and cued-language 
transliterators.
    Qualified interpreter for a limited English proficient individual 
means an interpreter who via a remote interpreting service or an on-
site appearance:
    (1) Has demonstrated proficiency in speaking and understanding both 
spoken English and at least one other spoken language;
    (2) Is able to interpret effectively, accurately, and impartially 
to and from such language(s) and English, using any necessary 
specialized vocabulary or terms without changes, omissions, or 
additions and while preserving the tone, sentiment, and emotional level 
of the original oral statement; and
    (3) Adheres to generally accepted interpreter ethics principles, 
including client confidentiality.
    Qualified reader means a person who is able to read effectively, 
accurately, and impartially using any necessary specialized vocabulary.
    Qualified translator means a translator who:
    (1) Has demonstrated proficiency in writing and understanding both 
written English and at least one other written non-English language;
    (2) Is able to translate effectively, accurately, and impartially 
to and from such language(s) and English, using any necessary 
specialized vocabulary or terms without changes, omissions, or 
additions and while preserving the tone, sentiment, and emotional level 
of the original written statement; and
    (3) Adheres to generally accepted translator ethics principles, 
including client confidentiality.
    Recipient means any State or its 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 indirectly, including any subunit, successor, assignee, or 
transferee of a recipient. Such term does not include any ultimate 
beneficiary.
    Section 504 means Section 504 of the Rehabilitation Act of 1973 
(Pub. L. 93-112; 29 U.S.C. 794), as amended.
    Section 1557 means Section 1557 of the ACA (42 U.S.C. 18116).
    State Exchange means an Exchange established by a State and 
approved by the Department pursuant to 45 CFR part 155, subpart B.
    Title I entity means any entity established under Title I of the 
ACA, as amended, including State Exchanges and Federally-facilitated 
Exchanges.
    Title VI means Title VI of the Civil Rights Act of 1964 (Pub. L. 
88-352; 42 U.S.C. 2000d et seq.), as amended.
    Title VII means Title VII of the Civil Rights Act of 1964 (Pub. L. 
88-352; 42 U.S.C. 2000e et seq.), as amended.
    Title IX means Title IX of the Education Amendments of 1972 (Pub. 
L. 92-318; 20 U.S.C. 1681 et seq.), as amended.


Sec.  92.5  Assurances required.

    (a) Assurances. An entity applying for Federal financial assistance 
to which this part applies must, as a condition of any application for 
Federal financial assistance, submit an assurance, on a form specified 
by the Director, that the entity's health programs and 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 must, as a condition of certification or 
approval, submit an assurance, on a form specified by the Director, 
that the health insurance issuer's or State's 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 section is the same as the duration of the assurances required 
in the Department's regulations implementing Section 504, 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.  92.6  Remedial action and voluntary action.

    (a) Remedial action. (1) If the Director finds that a recipient or 
State Exchange has discriminated against an individual on the basis of 
race, color, national origin, sex, age, or disability, in violation of 
Section 1557 or this part, such recipient or State Exchange must take 
such remedial action as the Director may require to overcome the 
effects of the discrimination.
    (2) Where a recipient is found to have discriminated against an 
individual on the basis of race, color, national origin, sex, age, or 
disability, in violation of Section 1557 or this part, and where 
another recipient exercises control over the recipient that has 
discriminated, the Director, where appropriate, may require either or 
both entities to take remedial action.
    (3) The Director may, where necessary to overcome the effects of 
discrimination in violation of Section 1557 or this part, require a 
recipient, in its health programs and activities, or State Exchange to 
take remedial action with respect to:
    (i) Persons who are no longer participants in the recipient's or 
State Exchange's health program or activity but who were participants 
in the health program or activity when such discrimination occurred; or
    (ii) Persons who would have been participants in the health program 
or activity had the discrimination not occurred.
    (b) Voluntary action. A covered entity may take nondiscriminatory 
steps, in addition to any action that is required by Section 1557 or 
this part, to overcome the effects of conditions that

[[Page 47914]]

result or resulted in limited participation in the covered entity's 
health programs or activities by persons on the basis of race, color, 
national origin, sex, age, or disability.


Sec.  92.7  Designation and responsibilities of a Section 1557 
Coordinator.

    (a) Section 1557 Coordinator and designees. A covered entity that 
employs fifteen or more persons must designate and authorize at least 
one employee, referred to herein as ``Section 1557 Coordinator,'' to 
coordinate the covered entity's compliance with its responsibilities 
under Section 1557 and this part in its health programs and activities, 
including the investigation of any grievance communicated to it 
alleging noncompliance with Section 1557 or this part or alleging any 
action that would be prohibited by Section 1557 or this part. As 
appropriate, a covered entity may assign one or more designees to carry 
out some of these responsibilities, but the Section 1557 Coordinator 
must retain ultimate oversight for ensuring coordination with the 
covered entity's compliance with this part.
    (b) Responsibilities of a Section 1557 Coordinator. A covered 
entity must ensure that, at minimum, the Section 1557 Coordinator:
    (1) Receives, reviews, and processes grievances, filed under the 
grievance procedure as set forth in Sec.  92.8(c);
    (2) Coordinates the covered entity's recordkeeping requirements as 
set forth in Sec.  92.8(c);
    (3) Coordinates effective implementation of the covered entity's 
language access procedures as set forth in Sec.  92.8(d);
    (4) Coordinates effective implementation of the covered entity's 
effective communication procedures as set forth in Sec.  92.8(e);
    (5) Coordinates effective implementation of the covered entity's 
reasonable modification procedures as set forth in Sec.  92.8(f); and
    (6) Coordinates training of relevant employees as set forth in 
Sec.  92.9 of this part, including maintaining documentation required 
by such section.


Sec.  92.8  Policies and procedures.

    (a) General requirement. A covered entity must implement written 
policies and procedures in its health programs and activities that are 
designed to comply with the requirements of this part. The policies and 
procedures must include an effective date and be reasonably designed, 
taking into account the size, complexity, and the type of health 
programs or activities undertaken by a covered entity, to ensure 
compliance with this part.
    (b) Nondiscrimination policy. A covered entity must implement a 
written policy in its health programs and activities that, at minimum, 
states the covered entity does not discriminate on the basis of race, 
color, national origin (including limited English proficiency and 
primary language), sex (including pregnancy, sexual orientation, gender 
identity, and sex characteristics), age, or disability; that the 
covered entity provides language assistance services and appropriate 
auxiliary aids and services free of charge, when necessary for 
compliance with Section 1557 or this part; that the covered entity will 
provide reasonable modifications for individuals with disabilities; and 
provides the contact information for the Section 1557 Coordinator 
required by Sec.  92.7 (if applicable).
    (c) Grievance procedures. (1) A covered entity that employs fifteen 
or more persons must implement written grievance procedures in its 
health programs and activities that provide for the prompt and 
equitable resolution of grievances alleging any action that would be 
prohibited by Section 1557 or this part.
    (2) A covered entity to which this paragraph applies must retain 
records related to grievances filed with it that allege discrimination 
on the basis of race, color, national origin, sex, age, or disability 
for no less than three (3) calendar years from the date of the filing 
of the grievance. The records must include the grievance; the name and 
contact information of the complainant (if provided by complainant); 
the alleged discriminatory action and alleged basis (or bases) of 
discrimination; the date the grievance was filed; grievance resolution; 
and any other pertinent information.
    (3) A covered entity to which this paragraph applies must keep 
confidential the identity of an individual who has filed a grievance 
under this part except as required by law or to the extent necessary to 
carry out the purposes of this part, including the conduct of any 
investigation.
    (d) Language access procedures. A covered entity must implement 
written language access procedures in its health programs and 
activities describing the covered entity's process for providing 
language assistance services to limited English proficient individuals 
when required under Sec.  92.201 of this part. At a minimum, the 
language access procedures must include current information detailing 
the contact information for the Section 1557 Coordinator (if 
applicable); how an employee identifies whether an individual is 
limited English proficient; how an employee obtains the services of 
qualified interpreters and translators the covered entity uses to 
communicate with a limited English proficient individual; the names of 
any qualified bilingual staff members; and a list and the location of 
any electronic and written translated materials the covered entity has 
and the languages they are translated into, and the publication date.
    (e) Effective communication procedures. A covered entity must 
implement written effective communication procedures in its health 
programs and activities describing the covered entity's process for 
ensuring effective communication for individuals with disabilities when 
required under Sec.  92.202. At a minimum, a covered entity's effective 
communication procedures must include current contact information for 
the Section 1557 Coordinator (if applicable); how an employee obtains 
the services of qualified interpreters the covered entity uses to 
communicate with individuals with disabilities, including the names of 
any qualified interpreter staff members, and how to access appropriate 
auxiliary aids and services.
    (f) Reasonable modification procedures. A covered entity must 
implement written procedures in its health programs and activities 
describing its process for making reasonable modifications to its 
policies, practices, or procedures when necessary to avoid 
discrimination on the basis of disability as required under Sec.  
92.205. At a minimum, the reasonable modification procedures must 
include contact information for the covered entity's Section 1557 
Coordinator (if applicable); a description of the covered entity's 
process for responding to requests from individuals with disabilities 
for changes, exceptions, or adjustments to a rule, policy, practice, or 
service of the covered entity; and a process for determining whether 
making the modification would fundamentally alter the nature of the 
health program or activity, including identifying an alternative 
modification that does not result in a fundamental alteration to ensure 
the individual with a disability receives the benefits or services in 
question.
    (g) Combined policies and procedures. A covered entity may combine 
the content of the policies and procedures required by paragraphs (b) 
through (f) of this section with any policies and procedures pursuant 
to Title VI, Section 504, Title IX, and the

[[Page 47915]]

Age Act if Section 1557 and the provisions in this part are clearly 
addressed therein.


Sec.  92.9  Training.

    (a) A covered entity must train relevant employees of its health 
programs and activities on the civil rights policies and procedures 
required by Sec.  92.8, as necessary and appropriate for the employees 
to carry out their functions within the covered entity consistent with 
the requirements of this part.
    (b) A covered entity must provide training that meets the 
requirements of paragraph (a) of this section, as follows:
    (1) To each relevant employee of the health program or activity as 
soon as possible, but no later than [DATE ONE YEAR AFTER EFFECTIVE DATE 
OF FINAL RULE];
    (2) Thereafter, to each new relevant employee of the health program 
or activity within a reasonable period of time after the employee joins 
the covered entity's workforce; and
    (3) To each relevant employee of the health program or activity 
whose functions are affected by a material change in the policies or 
procedures required by Sec.  92.8 of this part and any other civil 
rights policies or procedures the covered entity has implemented within 
a reasonable period of time after the material change has been made.
    (c) A covered entity must contemporaneously document its employees' 
completion of the training required by paragraphs (a) and (b) of this 
section in written or electronic form and maintain said documentation 
for no less than three (3) calendar years.


Sec.  92.10  Notice of nondiscrimination.

    (a) A covered entity must provide a notice of nondiscrimination to 
participants, beneficiaries, enrollees, and applicants of its health 
programs and activities, and members of the public.
    (1) The notice required under this paragraph (a) must include the 
following information relating to its health programs and activities:
    (i) The covered entity does not discriminate on the basis of race, 
color, national origin (including limited English proficiency and 
primary language), sex (including pregnancy, sexual orientation, gender 
identity, and sex characteristics), age, or disability;
    (ii) The covered entity provides reasonable modifications for 
individuals with disabilities, and appropriate auxiliary aids and 
services, including qualified interpreters for individuals with 
disabilities and information in alternate formats, such as braille or 
large print, free of charge and in a timely manner, when such 
modifications, aids, and services are necessary to ensure accessibility 
and an equal opportunity to participate to individuals with 
disabilities;
    (iii) The covered entity provides language assistance services, 
including electronic and written translated documents and oral 
interpretation free of charge and in a timely manner, when such 
services are necessary to provide meaningful access to a limited 
English proficient individual;
    (iv) How to obtain from the covered entity the reasonable 
modifications, appropriate auxiliary aids and services, and language 
assistance services in paragraphs (a)(1)(ii) and (iii) of this section;
    (v) The contact information for the covered entity's Section 1557 
Coordinator designated pursuant to Sec.  92.7 of this part (if 
applicable);
    (vi) The availability of the covered entity's grievance procedure 
pursuant to Sec.  92.8(c) of this part and how to file a grievance (if 
applicable);
    (vii) Details on how to file a discrimination complaint with OCR in 
the Department; and
    (viii) How to access the covered entity's website, if it has one, 
that provides the information required under paragraph (a)(1) of this 
section.
    (2) The notice must be provided in a covered entity's health 
program or activity, as follows:
    (i) On an annual basis to participants, beneficiaries, enrollees 
(including late and special enrollees), and applicants of its health 
program or activity;
    (ii) Upon request;
    (iii) At a conspicuous location on the covered entity's health 
program or activity website, if it has one; and
    (iv) In clear and prominent physical locations where it is 
reasonable to expect individuals seeking service from the health 
program or activity to be able to read or hear the notice.
    (b) A covered entity may combine the content of the notice required 
by paragraph (a) of this section with the notices required by 45 CFR 
80.6(d), 84.8, 86.9, and 91.32 if the combined notice clearly informs 
individuals of their civil rights under Section 1557 and this part, so 
long as it includes each of the elements required by paragraph (a)(1) 
of this section.


Sec.  92.11  Notice of availability of language assistance services and 
auxiliary aids and services.

    (a) A covered entity must provide a notice of availability of 
language assistance services and auxiliary aids and services that, at 
minimum, states that the covered entity, in its health programs or 
activities, provides language assistance services and appropriate 
auxiliary aids and services free of charge, when necessary for 
compliance with Section 1557 or this part, to participants, 
beneficiaries, enrollees, and applicants of its health program or 
activities, and members of the public.
    (b) This notice of availability of language assistance services and 
auxiliary aids and services must be provided in English and at least 
the 15 languages most commonly spoken by limited English proficient 
individuals of the relevant state or states and must be provided in 
alternate formats for individuals with disabilities who require 
auxiliary aids and services to ensure effective communication.
    (c) The notice required under paragraph (a) of this section must be 
provided in a covered entity's health program or activity, as follows:
    (1) On an annual basis to participants, beneficiaries, enrollees 
(including late and special enrollees), and applicants of its health 
program or activity;
    (2) Upon request;
    (3) At a conspicuous location on the covered entity's health 
program or activity website, if it has one;
    (4) In clear and prominent physical locations where it is 
reasonable to expect individuals seeking service from the health 
program or activity to be able to read or hear the notice; and
    (5) In the following electronic and written communications when 
these forms are provided by a covered entity:
    (i) Notice of nondiscrimination required by Sec.  92.10;
    (ii) Notice of privacy practices required by 45 CFR 164.520;
    (iii) Application and intake forms;
    (iv) Notices of denial or termination of eligibility, benefits or 
services, including Explanations of Benefits, and notices of appeal and 
grievance rights;
    (v) Communications related to a person's rights, eligibility, 
benefits, or services that require or request a response from a 
participant, beneficiary, enrollee, or applicant;
    (vi) Communications related to a public health emergency;
    (vii) Consent forms and instructions related to medical procedures 
or operations, medical power of attorney, or living will (with an 
option of providing only one notice for all documents bundled 
together);
    (viii) Discharge papers;
    (ix) Complaint forms; and
    (x) Patient and member handbooks.
    (d) A covered entity shall be deemed in compliance with this 
section with respect to an individual if it exercises the option to:

[[Page 47916]]

    (1) On an annual basis, provide the individual with the option to 
opt out of receipt of the notice required by this section in their 
primary language and through any appropriate auxiliary aids and 
services, and:
    (i) Does not condition the receipt of any aid or benefit on the 
individual's decision to opt out;
    (ii) Informs the individual that they have a right to receive the 
notice upon request in their primary language and through the 
appropriate auxiliary aids and services;
    (iii) Informs the individual that opting out of receiving the 
notice is not a waiver of their right to receive language assistance 
services and any appropriate auxiliary aids and services as required by 
this part;
    (iv) Documents, on an annual basis, that the individual has opted 
out of receiving the notice required by this section for that year; and
    (v) Does not treat a non-response from an individual as a decision 
to opt out; or
    (2) Document the individual's primary language and any appropriate 
auxiliary aids and services and:
    (i) Provides all materials and communications in that individual's 
primary language and through any appropriate auxiliary aids and 
services; or
    (ii) Provides the notice required by paragraph (a) of this section 
in that individual's primary language and through any appropriate 
auxiliary aids and services in all communications that are identified 
in paragraph (c)(5) of this section.

Subpart B--Nondiscrimination Provisions


Sec.  92.101  Discrimination prohibited.

    (a) General. (1) Except as provided in Title I of the ACA, an 
individual must not, on the basis of race, color, national origin, sex, 
age, or disability, be excluded from participation in, be denied the 
benefits of, or otherwise be subjected to discrimination under any 
health program or activity operated by a covered entity.
    (2) Discrimination on the basis of sex includes, but is not limited 
to, discrimination on the basis of sex stereotypes; sex 
characteristics, including intersex traits; pregnancy or related 
conditions; sexual orientation; and gender identity.
    (b) Specific prohibitions on discrimination. (1) In any health 
program or activity to which this part applies:
    (i) A recipient and State Exchange must comply with the specific 
prohibitions on discrimination in the Department's implementing 
regulations for Title VI, Section 504, Title IX, and the Age Act, found 
at parts 80, 84, 86 (subparts C and D), and 91 (subpart B) of this 
subchapter, respectively. Where this paragraph cross-references 
regulatory provisions that use the term ``recipient,'' the term 
``recipient or State Exchange'' shall apply in its place. Where this 
paragraph cross-references regulatory provisions that use the term 
``student,'' ``employee,'' or ``applicant,'' these terms shall be 
replaced with ``individual.''
    (ii) The Department, including Federally-facilitated Exchanges, 
must comply with specific prohibitions on discrimination in the 
Department's implementing regulations for Title VI, Section 504, Title 
IX, and the Age Act, found at parts 80, 85, 86 (subparts C and D), and 
91 (subpart B) of this subchapter, respectively. Where this paragraph 
cross-references regulatory provisions that use the term ``a 
recipient,'' the term ``the Department or a Federally-facilitated 
Exchange'' shall apply in its place. Where this paragraph cross-
references regulatory provisions that use the term ``student,'' 
``employee,'' or ``applicant,'' these terms shall be replaced with 
``individual.''
    (2) The enumeration of specific prohibitions on discrimination in 
paragraph (b)(1) of this section does not limit the general 
applicability of the prohibition in paragraph (a) of this section.

Subpart C--Specific Applications to Health Programs and Activities


Sec.  92.201  Meaningful access for limited English proficient 
individuals.

    (a) General requirement. A covered entity must take reasonable 
steps to provide meaningful access to each limited English proficient 
individual eligible to be served or likely to be directly affected by 
its health programs and activities.
    (b) Language assistance services requirements. Language assistance 
services required under paragraph (a) of this section must be provided 
free of charge, be accurate and timely, and protect the privacy and the 
independent decision-making ability of the limited English proficient 
individual.
    (c) Specific requirements for interpreter and translation services. 
(1) When interpretation services are required under this part, a 
covered entity must offer a qualified interpreter in its health 
programs and activities.
    (2) When translation services are required under this part, a 
covered entity must use a qualified translator in its health programs 
and activities.
    (3) If a covered entity uses machine translation when the 
underlying text is critical to the rights, benefits, or meaningful 
access of a limited English proficient individual, when accuracy is 
essential, or when the source documents or materials contain complex, 
non-literal or technical language, the translation must be reviewed by 
a qualified human translator.
    (d) Evaluation of compliance. In evaluating whether a covered 
entity has met its obligation under paragraph (a) of this section, the 
Director shall:
    (1) Evaluate, and give substantial weight to, the nature and 
importance of the health program or activity and the particular 
communication at issue, to the limited English proficient individual; 
and
    (2) Take into account other relevant factors, including the 
effectiveness of the covered entity's written language access 
procedures for its health programs and activities, that the covered 
entity has implemented pursuant to Sec.  92.8(d).
    (e) Restricted use of certain persons to interpret or facilitate 
communication. A covered entity must not, in its health programs and 
activities:
    (1) Require a limited English proficient individual to provide 
their own interpreter, or to pay the cost of their own interpreter;
    (2) Rely on an adult, not qualified as an interpreter, accompanying 
a limited English proficient individual to interpret or facilitate 
communication, except:
    (i) As a temporary measure, while finding a qualified interpreter 
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 limited English proficient individual immediately available and 
the qualified interpreter that arrives confirms or supplements the 
initial communications with the accompanying adult; or
    (ii) Where the limited English proficient individual specifically 
requests that the accompanying adult interpret or facilitate 
communication, the accompanying adult agrees to provide such 
assistance, the request and agreement by the accompanying adult is 
documented, and reliance on that adult for such assistance is 
appropriate under the circumstances.
    (3) Rely on a minor child to interpret or facilitate communication, 
except as a temporary measure while finding a qualified interpreter in 
an emergency involving an imminent threat to the safety or welfare of 
an individual or the

[[Page 47917]]

public where there is no qualified interpreter for the limited English 
proficient individual immediately available and the qualified 
interpreter that arrives confirms or supplements the initial 
communications with the minor child; or
    (4) Rely on staff other than qualified interpreters, qualified 
translators, or qualified bilingual/multilingual staff to communicate 
directly with limited English proficient individuals.
    (f) Video remote interpreting services. A covered entity that 
provides a qualified interpreter for a limited English proficient 
individual through video remote interpreting services in the covered 
entity's health programs and activities must provide:
    (1) Real-time full-motion video and audio over a dedicated high-
speed, wide-bandwidth video connection or wireless connection that 
delivers high quality video images that do not produce lags, choppy, 
blurry, or grainy images, or irregular pauses in communication;
    (2) A sharply delineated image that is large enough to display the 
interpreter's face and the participating person's face regardless of 
the person's body position;
    (3) A clear, audible transmission of voices; and
    (4) Adequate training to users of the technology and other involved 
persons so that they may quickly and efficiently set up and operate the 
video remote interpreting.
    (g) Audio remote interpreting services. A covered entity that 
provides a qualified interpreter for a limited English proficient 
individual through audio remote interpreting services in the covered 
entity's health programs and activities must provide:
    (1) Real-time audio over a dedicated high-speed, wide-bandwidth 
connection or wireless connection that delivers high-quality audio 
without lags or irregular pauses in communication;
    (2) A clear, audible transmission of voices; and
    (3) Adequate training to users of the technology and other involved 
persons so that they may quickly and efficiently set up and operate the 
remote interpreting services.
    (h) Acceptance of language assistance services is not required. 
Nothing in this section shall be construed to require a limited English 
proficient individual to accept language assistance services.


Sec.  92.202  Effective communication for individuals with 
disabilities.

    (a) A covered entity must take appropriate steps to ensure that 
communications with individuals with disabilities (including companions 
with disabilities), are as effective as communications with non-
disabled individuals in its health programs and activities, in 
accordance with the standards found at 28 CFR 35.130 and 28 CFR 35.160 
through 35.164. Where the regulatory provisions referenced in this 
section use the term ``public entity,'' the term ``covered entity'' 
shall apply in its place.
    (b) A covered entity must provide appropriate auxiliary aids and 
services to individuals with impaired sensory, manual, or speaking 
skills, where necessary to afford such individuals an equal opportunity 
to benefit from the service in question.


Sec.  92.203  Accessibility for buildings and facilities.

    (a) No qualified individual with a disability shall, because a 
covered entity's facilities are inaccessible to or unusable by 
individuals with disabilities, be denied the benefits of, be excluded 
from participation in, or otherwise be subjected to discrimination 
under any health program or activity to which this part applies.
    (b) 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 must comply with 
the 2010 Standards if the construction or alteration was commenced on 
or 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 must 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 must comply with the requirements for a 
``public building or facility'' as defined in section 106.5 of the 2010 
Standards.
    (c) 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.


Sec.  92.204  Accessibility of information and communication technology 
for individuals with disabilities.

    (a) A covered entity must ensure that its health programs and 
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. If an 
action required to comply with this section would result in such an 
alteration or such burdens, a covered entity shall take any other 
action that would not result in such an alteration or such burdens but 
would nevertheless ensure that, to the maximum extent possible, 
individuals with disabilities receive the benefits or services of the 
health program or activity provided by the covered entity.
    (b) A recipient or State Exchange shall ensure that its health 
programs and activities provided through websites and mobile 
applications comply with the requirements of Section 504 of the 
Rehabilitation Act, as interpreted consistent with Title II of the ADA 
(42 U.S.C. 12131 through 12165).


Sec.  92.205  Requirement to make reasonable modifications.

    A covered entity must make reasonable modifications to policies, 
practices, or procedures in its health programs and activities 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 ADA Title II regulation at 
28 CFR 35.130(b)(7).

[[Page 47918]]

Sec.  92.206  Equal program access on the basis of sex.

    (a) A covered entity must provide individuals equal access to its 
health programs and activities without discriminating on the basis of 
sex.
    (b) In providing access to health programs and activities, a 
covered entity must not:
    (1) Deny or limit health services, including those that are offered 
exclusively to individuals of one sex, to an individual based upon the 
individual's sex assigned at birth, gender identity, or gender 
otherwise recorded;
    (2) Deny or limit a health care professional's ability to provide 
health services on the basis of an individual's sex assigned at birth, 
gender identity, or gender otherwise recorded if such denial or 
limitation has the effect of excluding individuals from participation 
in, denying them the benefits of, or otherwise subjecting them to 
discrimination on the basis of sex under a covered health program or 
activity;
    (3) Adopt or apply any policy or practice of treating individuals 
differently or separating them on the basis of sex in a manner that 
subjects any individual to more than de minimis harm, including by 
adopting a policy or engaging in a practice that prevents an individual 
from participating in a health program or activity consistent with the 
individual's gender identity; or
    (4) Deny or limit health services sought for purpose of gender 
transition or other gender-affirming care that the covered entity would 
provide to an individual for other purposes if the denial or limitation 
is based on a patient's sex assigned at birth, gender identity, or 
gender otherwise recorded.
    (c) Nothing in this section requires the provision of any health 
service where the covered entity has a legitimate, nondiscriminatory 
reason for denying or limiting that service, including where the 
covered entity typically declines to provide the health service to any 
individual or where the covered entity reasonably determines that such 
health service is not clinically appropriate for a particular 
individual. However, a provider's belief that gender transition or 
other gender-affirming care can never be beneficial for such 
individuals (or its compliance with a state or local law that reflects 
a similar judgment) is not a sufficient basis for a judgment that a 
health service is not clinically appropriate.
    (d) The enumeration of specific forms of discrimination in 
paragraph (b) of this section does not limit the general applicability 
of the prohibition in paragraph (a) of this section.


Sec.  92.207  Nondiscrimination in health insurance and other health-
related coverage.

    (a) A covered entity must not, in providing or administering health 
insurance coverage or other health-related coverage, discriminate on 
the basis of race, color, national origin, sex, age, or disability.
    (b) A covered entity must not, in providing or administering health 
insurance coverage or other health-related coverage:
    (1) Deny, cancel, limit, or refuse to issue or renew health 
insurance coverage or other health-coverage, or deny or limit coverage 
of a claim, or impose additional cost sharing or other limitations or 
restrictions on coverage, on the basis of race, color, national origin, 
sex, age, or disability;
    (2) Have or implement marketing practices or benefit designs that 
discriminate on the basis of race, color, national origin, sex, age, or 
disability in health insurance coverage or other health-related 
coverage;
    (3) Deny or limit coverage, deny or limit coverage of a claim, or 
impose additional cost sharing or other limitations or restrictions on 
coverage, to an individual based upon the individual's sex at birth, 
gender identity, or gender otherwise recorded;
    (4) Have or implement a categorical coverage exclusion or 
limitation for all health services related to gender transition or 
other gender-affirming care;
    (5) Otherwise deny or limit coverage, deny or limit coverage of a 
claim, or impose additional cost sharing or other limitations or 
restrictions on coverage, for specific health services related to 
gender transition or other gender-affirming care if such denial, 
limitation, or restriction results in discrimination on the basis of 
sex; or
    (6) Have or implement benefit designs that do not provide or 
administer health insurance coverage or other health-related coverage 
in the most integrated setting appropriate to the needs of qualified 
individuals with disabilities.
    (c) Nothing in this section requires coverage of any health service 
where the covered entity has a legitimate, nondiscriminatory reason for 
determining that such health service fails to meet applicable coverage 
requirements, such as medical necessity requirements, in an individual 
case.
    (d) The enumeration of specific forms of discrimination in 
paragraph (b) of this section does not limit the general applicability 
of the prohibition in paragraph (a) of this section.


Sec.  92.208  Prohibition on sex discrimination related to marital, 
parental, or family status.

    In determining whether an individual satisfies any policy or 
criterion regarding access to its health programs or activities, a 
covered entity must not take an individual's sex into account in 
applying any rule concerning an individual's current, perceived, 
potential, or past marital, parental, or family status.


Sec.  92.209  Nondiscrimination on the basis of association.

    A covered entity must not exclude from participation in, deny the 
benefits of, or otherwise discriminate against an individual in its 
health programs and activities on the basis of the respective race, 
color, national origin, sex, age, or disability of the individual and 
another person with whom the individual has a relationship or 
association.


Sec.  92.210  Nondiscrimination in the use of clinical algorithms in 
decision-making.

    A covered entity must not discriminate on the basis of race, color, 
national origin, sex, age, or disability in its health programs and 
activities through the use of clinical algorithms in its decision-
making.


Sec.  92.211  Nondiscrimination in the delivery of health programs and 
activities through telehealth services.

    A covered entity must not, in delivery of its health programs and 
activities through telehealth services, discriminate on the basis of 
race, color, national origin, sex, age, or disability.

Subpart D--Procedures


Sec.  92.301  Enforcement mechanisms.

    The enforcement mechanisms available for and provided under Title 
VI of the Civil Rights Act of 1964, Title IX of the Education 
Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, and 
the Age Discrimination Act of 1975 shall apply for purposes of Section 
1557 as implemented by this part.


Sec.  92.302  Notification of views regarding application of Federal 
conscience and religious freedom laws.

    (a) A recipient may notify OCR of the recipient's view that it is 
exempt from certain provisions of this part due to the application of a 
Federal conscience or religious freedom law.
    (b) Once OCR receives such notification from a particular 
recipient, OCR shall promptly consider those views in responding to any 
complaints or otherwise determining whether to

[[Page 47919]]

proceed with any investigation or enforcement activity regarding that 
recipient's compliance with the relevant provisions of this part. Any 
relevant ongoing investigation or enforcement activity regarding the 
recipient shall be held in abeyance until a determination has been made 
under paragraph (c) of this section.
    (c) Based on the information provided in the notification under 
paragraph (a) of this section, OCR may determine at any time whether a 
recipient is exempt from the application of certain provisions of this 
part, or whether modified application of the provision is required as 
applied to specific contexts, procedures, or health care services, 
based on a Federal conscience or religious freedom law. OCR will assess 
whether there is a sufficiently concrete factual basis for making a 
determination and will apply the applicable legal standards of the 
relevant law. OCR will communicate its determination to the recipient.
    (d) If OCR determines that a recipient is exempt from the 
application of certain provisions of this part or modified application 
of certain provisions is required as applied to specific contexts, 
procedures, or health care services, based on a Federal conscience or 
religious freedom law, that determination does not otherwise limit the 
application of any other provision of this part to the recipient or to 
other contexts, procedures, or health care services.


Sec.  92.303  Procedures for health programs and activities conducted 
by recipients and State Exchanges.

    (a) The procedural provisions applicable to title VI apply with 
respect to administrative enforcement actions concerning discrimination 
on the basis of race, color, national origin, sex, and disability 
discrimination under Section 1557 or this part. These procedures are 
found at 45 CFR 80.6 through 80.11 and part 81 of this subchapter.
    (b) The procedural provisions applicable to the Age Act apply with 
respect to administrative enforcement actions concerning age 
discrimination under Section 1557 or this part. These procedures are 
found at 45 CFR 91.41 through 91.50.
    (c) When a recipient fails to provide OCR with requested 
information in a timely, complete, and accurate manner, OCR may, after 
attempting to reach voluntary resolution, find noncompliance with 
Section 1557 and initiate appropriate enforcement procedures, found at 
45 CFR 80.8, including beginning the process for fund suspension or 
termination and taking other action authorized by law.


Sec.  92.304  Procedures for health programs and activities 
administered by the Department.

    (a) This section applies to discrimination on the basis of race, 
color, national origin, sex, age, or disability in health programs and 
activities administered by the Department, including the Federally-
facilitated Exchanges.
    (b) The procedural provisions applicable to Section 504 at 45 CFR 
85.61 through 85.62 shall apply with respect to administrative 
enforcement actions against the Department concerning discrimination on 
the basis of race, color, national origin, sex, age, or disability 
under Section 1557 or this part. Where this section cross-references 
regulatory provisions that use the term ``handicap,'' the term ``race, 
color, national origin, sex, age, or disability'' shall apply in its 
place.
    (c) The Department must permit access by OCR to its books, records, 
accounts, other sources of information, and facilities as may be 
pertinent to ascertain compliance with Section 1557 or this part. Where 
any information required of the Department is in the exclusive 
possession of any other agency, institution or person, and the other 
agency, institution or person fails or refuses to furnish this 
information, the Department shall so certify and shall set forth what 
efforts it has made to obtain the information. Asserted considerations 
of privacy or confidentiality may not operate to bar OCR from 
evaluating or seeking to enforce compliance with Section 1557 or this 
part. Information of a confidential nature obtained in connection with 
compliance evaluation or enforcement shall not be disclosed except 
where necessary under the law.
    (d) The Department must not intimidate, threaten, coerce, 
retaliate, or otherwise discriminate against any individual or entity 
for the purpose of interfering with any right or privilege secured by 
Section 1557 or this part, or because such individual or entity has 
made a complaint, testified, assisted, or participated in any manner in 
an investigation, proceeding or hearing under Section 1557 or this 
part. The identity of complainants must be kept confidential by OCR in 
accordance with applicable Federal law.

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

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

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


Sec.  147.104  [Amended]

0
17. Amend Sec.  147.104 in paragraph (e) by removing the term ``sex'' 
and adding in its place the phrase ``sex (including sexual orientation 
and gender identity)''.

PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED 
STANDARDS UNDER THE AFFORDABLE CARE ACT

0
18.The authority citation for part 155 is amended to read as follows:

    Authority: 42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 
18051, 18054, 18071, 18081-18083, and 18116.


Sec.  155.120  [Amended]

0
19. Amend Sec.  155.120 in paragraph (c)(1)(ii) by removing the term 
``sex'' and adding in its place the phrase ``sex (including sexual 
orientation and gender identity)''.


Sec.  155.220  [Amended]

0
20. Amend Sec.  155.220 in paragraph (j)(2)(i) by removing the term 
``sex'' and adding in its place the phrase ``sex (including sexual 
orientation and gender identity)''.

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

0
21. The authority citation for part 156 is amended to read as follows:

    Authority: 42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 
18044, 18054, 18061, 18063, 18071, 18082, 18116, and 26 U.S.C. 36B.


Sec.  156.200  [Amended]

0
22. Amend Sec.  156.200 in paragraph (e) by removing the term ``sex'' 
and adding in its place the phrase ``sex (including sexual orientation 
and gender identity)''.

[[Page 47920]]

Sec.  156.1230  [Amended]

0
23. Amend Sec.  156.1230 in paragraph (b)(2) by removing the term 
``sex'' and adding in its place the phrase ``sex (including sexual 
orientation and gender identity)''.

    Dated: July 25, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-16217 Filed 7-28-22; 4:15 pm]
 BILLING CODE 4153-01-P