Proposed Rule2022-16217

Nondiscrimination in Health Programs and Activities

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
August 4, 2022

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

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.

Full Text

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<title>Federal Register, Volume 87 Issue 149 (Thursday, August 4, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.zoomgov.com/meeting/register/vJIsfu-rqzksEl2T8gUp_lDrWBqkU0223CY">https://www.zoomgov.com/meeting/register/vJIsfu-rqzksEl2T8gUp_lDrWBqkU0223CY</a>.
    Federal Rulemaking Portal: You may submit electronic comments at 
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="/cdn-cgi/l/email-protection#2f1e1a1a186f134e0f475d4a4912" http: hhs.gov">hhs.gov</a>">1557@<a href="http://hhs.gov">hhs.gov</a></a>, 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 
<a href="/cdn-cgi/l/email-protection#0b3a3e3e3c4b376a2b63796e6d36" http: hhs.gov">hhs.gov</a>">1557@<a href="http://hhs.gov">hhs.gov</a></a>.

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), 
<a href="https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/statement.pdf">https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/statement.pdf</a>; OCR Enforcement under Section 1557 of 
the Affordable Care Act Sex Discrimination Cases, U.S. Dep't of 
Health & Human Servs., <a href="https://www.hhs.gov/civil-rights/for-individuals/section-1557/ocr-enforcement-section-1557-aca-sex-discrimination/index.html">https://www.hhs.gov/civil-rights/for-individuals/section-1557/ocr-enforcement-section-1557-aca-sex-discrimination/index.html</a> (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 <a href="https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments">https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments</a>.
    \10\ 80 FR 54171 (Sept. 8, 2015). The 2015 NPRM received roughly 
2,160 comments, which are available for public inspection at <a href="https://www.regulations.gov/docket/HHS-OCR-2015-0006/comments">https://www.regulations.gov/docket/HHS-OCR-2015-0006/comments</a>.
    \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 <a href="https://www.regulations.gov/docket/HHS-OCR-2019-0007">https://www.regulations.gov/docket/HHS-OCR-2019-0007</a>.
    \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).
---------------------------------------------------------------------------

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), <a href="https://www.hhs.gov/sites/default/files/hhs-ocr-notice-and-guidance-gender-affirming-care.pdf">https://www.hhs.gov/sites/default/files/hhs-ocr-notice-and-guidance-gender-affirming-care.pdf</a>.
    \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), <a href="https://www.justice.gov/opa/press-release/file/1489066/download">https://www.justice.gov/opa/press-release/file/1489066/download</a>.
---------------------------------------------------------------------------

    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, 
<a href="http://HealthCare.gov">HealthCare.gov</a>, <a href="https://www.healthcare.gov/glossary/health-coverage/">https://www.healthcare.gov/glossary/health-coverage/</a> 
(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], <a href="https://www.justice.gov/crt/page/file/1383026/download">https://www.justice.gov/crt/page/file/1383026/download</a>; 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\
---------------------------------------------------------------------------

    \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 <a href="http://federalregister.gov">federalregister.gov</a>.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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\
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    \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.
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    \72\ Id. Sec.  84.7(b).
    \73\ Id. Sec.  86.8(b).
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    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.
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    \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.
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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\
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    \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, 
<a href="https://ssir.org/articles/entry/ensuring_equitable_access_to_vaccines#">https://ssir.org/articles/entry/ensuring_equitable_access_to_vaccines#</a>.
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    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), <a href="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/">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/</a>; Memorandum on 
Condemning and Combating Racism, Xenophobia, and Intolerance Against 
Asian Americans and Pacific Islanders in the United States (2021), 
<a href="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/">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/</a>; 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), <a href="https://www.congress.gov/congressional-record/2010/03/23/senate-section/article/S1821-6">https://www.congress.gov/congressional-record/2010/03/23/senate-section/article/S1821-6</a>.
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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, <a href="https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=26">https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=26</a> (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), <a href="https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2019.305523">https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2019.305523</a>.
    \83\ Id.
    \84\ U.S. Dep't of Health & Human Servs., Office of Minority 
Health, Profile: Hispanic/Latino Americans <a href="https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=64">https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=64</a> (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 (<a href="http://hhs.gov">hhs.gov</a>).
    \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), <a href="https://aspe.hhs.gov/sites/default/files/private/pdf/265286/Uninsured-Population-Issue-Brief.pdf">https://aspe.hhs.gov/sites/default/files/private/pdf/265286/Uninsured-Population-Issue-Brief.pdf</a>.
    \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), <a href="https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2021qdr.pdf">https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2021qdr.pdf</a>.
    \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, <a href="https://health.gov/healthypeople/objectives-and-data/social-determinants-health">https://health.gov/healthypeople/objectives-and-data/social-determinants-health</a> (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), <a href="https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2019qdr-final-es-cs061721.pdf">https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2019qdr-final-es-cs061721.pdf</a>.
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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), <a href="https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/E-stat-Maternal-Mortality-Rates-2022.pdf">https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/E-stat-Maternal-Mortality-Rates-2022.pdf</a>.
    \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), 
<a href="https://ajph.aphapublications.org/doi/10.2105/AJPH.2021.306375">https://ajph.aphapublications.org/doi/10.2105/AJPH.2021.306375</a>.
    \94\ The White House Briefing Room, A Proclamation on Black 
Maternal Health Week, 2021 (April 13, 2021), <a href="http://www.whitehouse.gov/briefing-room/presidential-actions/2021/04/13/a-proclamation-on-black-maternal-health-week-2021/">www.whitehouse.gov/briefing-room/presidential-actions/2021/04/13/a-proclamation-on-black-maternal-health-week-2021/</a>;see also, The White House Briefing 
Room, A Proclamation on Black Maternal Health Week, 2022 (April 8, 
2022), <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2022/04/08/a-proclamation-on-black-maternal-health-week-2022/">https://www.whitehouse.gov/briefing-room/presidential-actions/2022/04/08/a-proclamation-on-black-maternal-health-week-2022/</a>.
    \95\ The White House Briefing Room, FACT SHEET: Biden-Harris 
Administration Announces Initial Actions to Address the Black 
Maternal Health Crisis (Apr. 13, 2021), <a href="http://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./">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./</a>
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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), <a href="https://www.liebertpub.com/doi/epdf/10.1089/jwh.2020.8890">https://www.liebertpub.com/doi/epdf/10.1089/jwh.2020.8890</a>.
    \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), <a href="https://doi.org/10.1073/pnas.1516047113">https://doi.org/10.1073/pnas.1516047113</a>.
    \99\ Michael Sun et al., Negative Patient Descriptors: 
Documenting Racial Bias in the Electronic Health Record, 41 Health 
Affairs 203, 211 (2022), <a href="https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2021.01423">https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2021.01423</a>.
    \100\ Liz Hamel et al., The Kaiser Family Found., The Undefeated 
Survey on Race and Health, p. 4 (2020), <a href="https://files.kff.org/attachment/Report-Race-Health-and-COVID-19-The-Views-and-Experiences-of-Black-Americans.pdf">https://files.kff.org/attachment/Report-Race-Health-and-COVID-19-The-Views-and-Experiences-of-Black-Americans.pdf</a>.
    \101\ Id. at 5.
    \102\ Jamila Taylor, The Century Found., Racism, Inequality, and 
Health Care for African Americans, p. 6 (2019), <a href="https://production-tcf.imgix.net/app/uploads/2019/12/19172443/AfAmHealth_Jamila_PDF.pdf">https://production-tcf.imgix.net/app/uploads/2019/12/19172443/AfAmHealth_Jamila_PDF.pdf</a>.
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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''), <a href="https://journalofethics.ama-assn.org/sites/journalofethics.ama-assn.org/files/2021-02/cscm3-2102.pdf">https://journalofethics.ama-assn.org/sites/journalofethics.ama-assn.org/files/2021-02/cscm3-2102.pdf</a>.
    \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), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5309198/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5309198/</a>.
    \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), <a href="https://www.tandfonline.com/doi/pdf/10.1080/19371910903240704?needAccess=true">https://www.tandfonline.com/doi/pdf/10.1080/19371910903240704?needAccess=true</a>.
    \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), 
<a href="https://www.ahrq.gov/health-literacy/professional-training/lepguide/exec-summary.html#what">https://www.ahrq.gov/health-literacy/professional-training/lepguide/exec-summary.html#what</a>.
    \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), <a href="https://pubmed.ncbi.nlm.nih.gov/22424655/">https://pubmed.ncbi.nlm.nih.gov/22424655/</a>; 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, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789075/pdf/AJEM-3-e38.pdf">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789075/pdf/AJEM-3-e38.pdf</a>.
    \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), <a href="https://www.healthaffairs.org/do/10.1377/hblog20200724.76821/full/">https://www.healthaffairs.org/do/10.1377/hblog20200724.76821/full/</a>.
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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., <a href="https://www.nichd.nih.gov/health/topics/womenshealth/conditioninfo/howconditionsaffect">https://www.nichd.nih.gov/health/topics/womenshealth/conditioninfo/howconditionsaffect</a> (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), <a href="https://www.pnas.org/doi/epdf/10.1073/pnas.1800097115">https://www.pnas.org/doi/epdf/10.1073/pnas.1800097115</a>.
    \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, <a href="https://downloads.hindawi.com/journals/prm/2018/6358624.pdf">https://downloads.hindawi.com/journals/prm/2018/6358624.pdf</a>; 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), <a href="https://www.dovepress.com/getfile.php?fileID=42642">https://www.dovepress.com/getfile.php?fileID=42642</a>.
    \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), <a href="https://www.acpjournals.org/doi/full/10.7326/M14-2482?journalCode=aim">https://www.acpjournals.org/doi/full/10.7326/M14-2482?journalCode=aim</a>.
    \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), <a href="https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-updated-vol-32.pdf">https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-updated-vol-32.pdf</a>.
    \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), <a href="https://doi.org/10.17226/25877">https://doi.org/10.17226/25877</a>.
    \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), <a href="https://whatweknow.inequality.cornell.edu/wp-content/uploads/2019/12/LGBT-Discrimination-Printable-Findings-121319.pdf">https://whatweknow.inequality.cornell.edu/wp-content/uploads/2019/12/LGBT-Discrimination-Printable-Findings-121319.pdf</a>.
    \127\ Lesbian, Gay, Bisexual, and Transgender Health, 
<a href="http://HealthyPeople.gov">HealthyPeople.gov</a>, <a href="https://healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health">https://healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health</a> (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), <a href="https://williamsinstitute.law.ucla.edu/wp-content/uploads/LGBT-Race-Comparison-Jan-2022.pdf">https://williamsinstitute.law.ucla.edu/wp-content/uploads/LGBT-Race-Comparison-Jan-2022.pdf</a>.
    \129\ Sharita Gruberg et al., Ctr. for Am. Progress, The State 
of the LGBTQ Community in 2020 (2020), <a href="https://www.americanprogress.org/issues/lgbtq-rights/reports/2020/10/06/491052/state-lgbtq-community-2020/">https://www.americanprogress.org/issues/lgbtq-rights/reports/2020/10/06/491052/state-lgbtq-community-2020/</a>.
    \130\ Sandy E. James et al., Nat'l Ctr. for Transgender 
Equality, The Report of the 2015 U.S. Transgender Survey, p. 97 
(2016), <a href="https://transequality.org/sites/default/files/docs/usts/USTS-Full-Report-Dec17.pdf">https://transequality.org/sites/default/files/docs/usts/USTS-Full-Report-Dec17.pdf</a>.
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    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), <a href="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">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</a>.
    \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), 
<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559554/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559554/</a>; 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, 
<a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240088">https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240088</a>.
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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), <a href="https://aspe.hhs.gov/sites/default/files/2021-07/lgbt-health-ib.pdf">https://aspe.hhs.gov/sites/default/files/2021-07/lgbt-health-ib.pdf</a>.
    \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), <a href="https://www.kff.org/health-reform/issue-brief/demographics-insurance-coverage-and-access-to-care-among-transgender-adults/">https://www.kff.org/health-reform/issue-brief/demographics-insurance-coverage-and-access-to-care-among-transgender-adults/</a>.
    \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], <a href="https://www.wpath.org/media/cms/Documents/SOC%20v7/SOC%20V7_English2012.pdf?_t=1613669341">https://www.wpath.org/media/cms/Documents/SOC%20v7/SOC%20V7_English2012.pdf?_t=1613669341</a> (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.
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    \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, 
<a href="http://www.sciencedirect.com/science/article/pii/S0165178122000051">www.sciencedirect.com/science/article/pii/S0165178122000051</a>.
    \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, <a href="https://www.sciencedirect.com/science/article/pii/S0165178121000226">https://www.sciencedirect.com/science/article/pii/S0165178121000226</a>; 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), <a href="https://www.tandfonline.com/doi/pdf/10.1080/00918369.2020.1868182?needAccess=true">https://www.tandfonline.com/doi/pdf/10.1080/00918369.2020.1868182?needAccess=true</a>; 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), <a href="http://www.tandfonline.com/doi/full/10.1080/00918369.2020.1868184">www.tandfonline.com/doi/full/10.1080/00918369.2020.1868184</a>.
    \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), <a href="https://williamsinstitute.law.ucla.edu/wp-content/uploads/COVID-LGBT-Fall-Surge-Feb-2021.pdf">https://williamsinstitute.law.ucla.edu/wp-content/uploads/COVID-LGBT-Fall-Surge-Feb-2021.pdf</a>.
    \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\
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    \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), <a href="https://doi.org/10.2105/AJPH.2019.305123">https://doi.org/10.2105/AJPH.2019.305123</a>.
    \149\ Why Ageism in Health Care Is a Growing Concern, 
<a href="http://RegisCollege.edu">RegisCollege.edu</a>, <a href="https://online.regiscollege.edu/blog/why-ageism-in-health-care-is-a-growing-concern/">https://online.regiscollege.edu/blog/why-ageism-in-health-care-is-a-growing-concern/</a> (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), <a href="https://khn.org/news/article/ageism-health-care-seniors-decry-bias-inappropriate-treatment/">https://khn.org/news/article/ageism-health-care-seniors-decry-bias-inappropriate-treatment/</a>.
    \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), <a href="https://doi.org/10.1007/s11606-015-3233-6">https://doi.org/10.1007/s11606-015-3233-6</a>.
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    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, <a href="https://www.cdc.gov/nchs/covid19/mortality-overview.htm">https://www.cdc.gov/nchs/covid19/mortality-overview.htm</a> (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, <a href="https://www.cms.gov/medicare-covid-19-nursing-home-analysis">https://www.cms.gov/medicare-covid-19-nursing-home-analysis</a> (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), <a href="https://doi.org/10.1377/hlthaff.2018.05322">https://doi.org/10.1377/hlthaff.2018.05322</a>.
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    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\
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    \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), <a href="https://doi.org/10.26099/yffm-2x15">https://doi.org/10.26099/yffm-2x15</a>.
    \160\ Id.
    \161\ Id.
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    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\
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    \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, <a href="https://www.cdc.gov/aging/publications/features/Alz-Greater-Risk.html">https://www.cdc.gov/aging/publications/features/Alz-Greater-Risk.html</a> (last visited Mar. 15, 2022).
    \163\ Id.
    \164\ Alzheimer's Ass'n, Special Report: Race, Ethnicity and 
Alzheimer's in America, p. 72 (2021), <a href="https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special-report.pdf">https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special-report.pdf</a>.
    \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\
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    \166\ Maria Trent et al., The Impact of Racism on Child and 
Adolescent Health, 144 Am. Acad. of Pediatrics, Aug. 1, 2019, 
<a href="https://publications.aap.org/pediatrics/article/144/2/e20191765/38466/The-Impact-of-Racism-on-Child-and-Adolescent">https://publications.aap.org/pediatrics/article/144/2/e20191765/38466/The-Impact-of-Racism-on-Child-and-Adolescent</a>.
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    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), <a href="https://www.ncbi.nlm.nih.gov/books/NBK44192/pdf/Bookshelf_NBK44192.pdf">https://www.ncbi.nlm.nih.gov/books/NBK44192/pdf/Bookshelf_NBK44192.pdf</a>.
    \168\ Health Effects of Lead Exposure, U.S. Dep't of Health & 
Human Servs., Ctrs. for Disease Control & Prevention, <a href="https://www.cdc.gov/nceh/lead/prevention/health-effects.htm">https://www.cdc.gov/nceh/lead/prevention/health-effects.htm</a> (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, <a href="https://publications.aap.org/pediatrics/article/139/5/e20164266/38761/Assessing-Child-Lead-Poisoning-Case-Ascertainment">https://publications.aap.org/pediatrics/article/139/5/e20164266/38761/Assessing-Child-Lead-Poisoning-Case-Ascertainment</a>; 
Who is Vulnerable to Childhood Lead Poisoning, Tracking California, 
<a href="https://www.trackingcalifornia.org/childhood-lead-poisoning/who-is-vulnerable-to-childhood-lead-poisoning">https://www.trackingcalifornia.org/childhood-lead-poisoning/who-is-vulnerable-to-childhood-lead-poisoning</a> (last visited Mar. 15, 2022).
    \170\ See, e.g., Roberts, supra note 169; Who is Vulnerable to 
Childhood Lead Poisoning, supra note 169.
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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\
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    \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), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5302214/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5302214/</a>; Gloria L. Krahn et 
al., Persons with Disabilities as an Unrecognized Health Disparity 
Population, 205 Am. J. Pub. Health S198 (Apr. 2015), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355692/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355692/</a>; 2020 Topics and 
Objectives: Disability and Health, <a href="http://HealthyPeople.gov">HealthyPeople.gov</a>, <a href="https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health">https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health</a> (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), <a href="https://pubmed.ncbi.nlm.nih.gov/25263459/">https://pubmed.ncbi.nlm.nih.gov/25263459/</a>.
    \172\ Debra L. Brucker & Andrew J. Houtenville, People with 
Disabilities in the United States, 96 Archives of Physical Medicine 
and Rehabilitation 771 (2015), <a href="https://doi.org/10.1016/j.apmr.2015.02.024">https://doi.org/10.1016/j.apmr.2015.02.024</a>.
    \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), 
<a href="https://ncd.gov/sites/default/files/Documents/NCD_Medical_Equipment_Report_508.pdf">https://ncd.gov/sites/default/files/Documents/NCD_Medical_Equipment_Report_508.pdf</a>.
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    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\
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    \174\ Lisa I. Iezzoni et al., Physicians' Perceptions of People 
with Disability and Their Health Care, 40 Health Affairs 297 (2021), 
<a href="https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01452">https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01452</a>. 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), <a href="https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2021.01136">https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2021.01136</a>.
    \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), <a href="https://www.annemergmed.com/article/S0196-0644">https://www.annemergmed.com/article/S0196-0644</a>(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), <a href="https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf">https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf</a>; Laura 
VanPuymbrouck et al., Explicit and Implicit Disability Attitudes of 
Healthcare Providers, 65 Rehab. Psychology 101 (2020), <a href="https://pubmed.ncbi.nlm.nih.gov/32105109/">https://pubmed.ncbi.nlm.nih.gov/32105109/</a>.
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    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\
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    \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), <a href="https://www.healthaffairs.org/do/10.1377/hblog20210325.480382/full/">https://www.healthaffairs.org/do/10.1377/hblog20210325.480382/full/</a>.
    \177\ 2020 Topics and Objectives: Disability and Health, 
<a href="http://HealthyPeople.gov">HealthyPeople.gov</a>, <a href="https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health">https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health</a> (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), <a href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.01891">https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.01891</a>.
    \179\ Id.
    \180\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & 
Medicaid Servs., Medicare Current Beneficiary Survey (2013), <a href="https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-ADA-2017.pdf">https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-ADA-2017.pdf</a>.
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    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\
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    \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), <a href="https://doi.org/10.1089/jwh.2020.8864">https://doi.org/10.1089/jwh.2020.8864</a>.
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    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\
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    \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), 
<a href="https://doi.org/10.1016/j.dhjo.2021.101103">https://doi.org/10.1016/j.dhjo.2021.101103</a>.
    \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), <a href="https://www.hhs.gov/about/news/2021/07/26/hhs-doj-issue-guidance-on-long-covid-and-disability-rights.html">https://www.hhs.gov/about/news/2021/07/26/hhs-doj-issue-guidance-on-long-covid-and-disability-rights.html</a>.
    \184\ Civil Rights and COVID-19, U.S. Dep't of Health & Human 
Servs., Office for Civil Rights, <a href="https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html">https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html</a> (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), <a href="https://www.hhs.gov/sites/default/files/ocr-bulletin-3-28-20.pdf">https://www.hhs.gov/sites/default/files/ocr-bulletin-3-28-20.pdf</a>.
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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.''
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    \188\ Id. 18116(a) (emphasis added).
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    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.
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    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'').
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    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\
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    \191\ 85 FR 37160, 37169 (June 19, 2020).
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    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.
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    \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), <a href="https://www.census.gov/content/dam/Census/library/publications/2020/demo/p60-271.pdf">https://www.census.gov/content/dam/Census/library/publications/2020/demo/p60-271.pdf</a>.
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    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).
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    \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\
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    \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''').
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    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\
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    \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.

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[[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\
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    \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.
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    \211\ 85 FR at 37208.
    \212\ 42 U.S.C. 18116(a).
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    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.
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    \213\ Id. Sec.  18116.
    \214\ Id. 18116(a) (emphasis added).
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    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.
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    \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, <a href="https://pubmed.ncbi.nlm.nih.gov/31880794/">https://pubmed.ncbi.nlm.nih.gov/31880794/</a> (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), <a href="https://coloradosun.com/2021/09/16/hospital-merger-scl-health-colorado/">https://coloradosun.com/2021/09/16/hospital-merger-scl-health-colorado/</a>.
    \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, 
<a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759762">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759762</a> 
(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, 
<a href="https://www.modernhealthcare.com/operations/most-catholic-hospitals-dont-disclose-religious-care-restrictions">https://www.modernhealthcare.com/operations/most-catholic-hospitals-dont-disclose-religious-care-restrictions</a>.
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    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.
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    \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.
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    \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.
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    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\
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    \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).
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    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\
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    \226\ See 28 CFR pt. 35, app. A, B, C.
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    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).
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    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.
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    \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).
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    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).
---------------------------------------------------------------------------

    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), <a href="https://www.hhs.gov/sites/default/files/csr-payment-memo.pdf">https://www.hhs.gov/sites/default/files/csr-payment-memo.pdf</a>.
    \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), <a href="https://www.cms.gov/files/document/1332-co-extension-approval-letter-stcs.pdf">https://www.cms.gov/files/document/1332-co-extension-approval-letter-stcs.pdf</a>.
    \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).
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    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.
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    \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).
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    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.
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    \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).
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    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.
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    \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'').
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    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\
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    \257\ See, e.g., Fain, 545 F. Supp. 3d at 342 (`` `health 
program or activity' under Section 1557 necessarily includes health 
insurance issuers'').
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    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\
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    \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) Med

[…truncated; see source link]
Indexed from Federal Register on August 4, 2022.

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