Nondiscrimination in Health Programs and Activities, 47824-47920 [2022-16217]
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Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Proposed Rules
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
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.
AGENCY:
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 AllInclusive 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 webbrokers 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
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SUMMARY:
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with Indian Tribal Governments, the
Department of Health and Human
Services’ Tribal Consultation Policy,
and the Department’s Plan for
Implementing Executive Order 13175,
the Office for Civil Rights solicits input
by tribal officials as we develop the
implementing regulations for Section
1557 of the Affordable Care Act at 45
CFR part 92. The Tribal consultation
meeting will be held on August 31,
2022, from 2 p.m. to 4 p.m. Eastern
Daylight Time.
ADDRESSES: You may submit comments,
identified by RIN Number 0945–AA17,
by any of the following methods. Please
do not submit duplicate comments.
To participate in the Tribal
consultation meeting, you must register
in advance at https://
www.zoomgov.com/meeting/register/
vJIsfu-rqzksEl2T8gUp_
lDrWBqkU0223CY.
Federal Rulemaking Portal: You may
submit electronic comments at https://
www.regulations.gov by searching for
the Docket ID number HHS–OS–2022–
0012. Follow the instructions for
submitting electronic comments. If you
are submitting comments electronically,
the Department strongly encourages you
to submit any comments or attachments
in Microsoft Word format. If you must
submit a comment in Adobe Portable
Document Format (PDF), the
Department strongly encourages you to
convert the PDF to ‘‘print-to-PDF’’
format, or to use some other commonly
used searchable text format. Please do
not submit the PDF in a scanned format.
Using a print-to-PDF format allows the
Department to electronically search and
copy certain portions of your
submissions to assist in the rulemaking
process.
Regular, Express, or Overnight Mail:
You may mail written comments to the
following address only: U.S. Department
of Health and Human Services, Office
for Civil Rights, Attention: 1557 NPRM
(RIN 0945–AA17), Hubert H. Humphrey
Building, Room 509F, 200
Independence Avenue SW, Washington,
DC 20201.
All comments received by the
methods and due date specified above
may be posted without change to
content to https://www.regulations.gov,
which may include personal
information provided about the
commenter, and such posting may occur
after the closing of the comment period.
However, the Department may redact
certain non-substantive content from
comments before posting, including
threats, hate speech, profanity, graphic
images, or individually identifiable
information about a third-party
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individual other than the commenter. In
addition, comments or material
designated as confidential or not to be
disclosed to the public will not be
accepted. Comments may be redacted or
rejected as described above without
notice to the commenter, and the
Department will not consider in
rulemaking any redacted or rejected
content that would not be made
available to the public as part of the
administrative record.
Because of the large number of public
comments normally received on Federal
Register documents, OCR is not able to
provide individual acknowledgments of
receipt.
Please allow sufficient time for mailed
comments to be received timely in the
event of delivery or security delays.
Please note that comments submitted
by fax or email and those submitted
after the comment period will not be
accepted.
Docket: For complete access to
background documents or posted
comments, go to https://
www.regulations.gov and search for
Docket ID number HHS–OS–2022–0012.
FOR FURTHER INFORMATION CONTACT:
Office for Civil Rights
Dylan Nicole de Kervor, (202) 240–
3110 or (800) 537–7697 (TDD), or via
email at 1557@hhs.gov, for matters
related to Section 1557.
Centers for Medicare & Medicaid
Services
John Giles, (410) 786–5545, for matters
related to Medicaid.
Emily King, 410–786–8537, for matters
related to CHIP.
Timothy Roe, (410) 786–2006 for
matters related to Programs of AllInclusive 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
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Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Proposed Rules
call (202) 240–3110 or (800) 537–7697
(TDD) for assistance or email 1557@
hhs.gov.
SUPPLEMENTARY INFORMATION:
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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 (§ 92.1)
Application (§ 92.2)
Relationship to Other Laws (§ 92.3)
Definitions (§ 92.4)
Assurances Required (§ 92.5)
Remedial Action and Voluntary Action
(§ 92.6)
Designation and Responsibilities of a
Section 1557 Coordinator (§ 92.7)
Policies and Procedures (§ 92.8)
Training (§ 92.9)
Notice of Nondiscrimination (§ 92.10)
Notice of Availability of Language
Assistance Services and Auxiliary Aids
and Services (§ 92.11)
Subpart B—Nondiscrimination Provisions
Discrimination Prohibited (§ 92.101)
Subpart C—Specific Applications to
Health Programs and Activities
Meaningful Access for Limited English
Proficient Individuals (§ 92.201)
Effective Communication for Individuals
With Disabilities (§ 92.202)
Accessibility for Buildings and Facilities
(§ 92.203)
Accessibility of Information and
Communication Technology for
Individuals With Disabilities (§ 92.204)
Requirement To Make Reasonable
Modifications (§ 92.205)
Equal Program Access on the Basis of Sex
(§ 92.206)
Nondiscrimination in Health Insurance
Coverage and Other Health-Related
Coverage (§ 92.207)
Prohibition on Sex Discrimination Related
to Marital, Parental, or Family Status
(§ 92.208)
Nondiscrimination on the Basis of
Association (§ 92.209)
Use of Clinical Algorithms in DecisionMaking (§ 92.210)
Nondiscrimination in the Delivery of
Health Programs and Activities Through
Telehealth Services (§ 92.211)
Subpart D—Procedures
Enforcement Mechanisms (§ 92.301)
Notification of Views Regarding
Application of Federal Conscience and
Religious Freedom Laws (§ 92.302)
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Procedures for Health Programs and
Activities Conducted by Recipients and
State Exchanges (§ 92.303)
Procedures for Health Programs and
Activities Administered by the
Department (§ 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
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
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
I. Background
1. 2016 Rulemaking
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
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
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.’’
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2 42
U.S.C. 2000d et seq.
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).
8 See, e.g., Bulletin, U.S. Dep’t of Health & Human
Servs., The Brooklyn Hospital Center Implements
Non-Discriminatory Practices to Ensure Equal Care
for Transgender Patients (July 14, 2015), https://
www.hhs.gov/sites/default/files/ocr/civilrights/
activities/agreements/TBHC/statement.pdf; OCR
Enforcement under Section 1557 of the Affordable
Care Act Sex Discrimination Cases, U.S. Dep’t of
Health & Human Servs., https://www.hhs.gov/civilrights/for-individuals/section-1557/ocrenforcement-section-1557-aca-sex-discrimination/
index.html (last updated Aug. 1, 2016); see also C.P.
v. Blue Cross Blue Shield, 536 F. Supp. 3d 791, 796
(W.D. Wash. 2021) (citing Tovar v. Essentia Health,
342 F. Supp. 3d 947, 957 (D. Minn. 2018) (stating
‘‘[a] claim of discrimination in violation of Section
1557 does not depend on an HHS rule’’ in denying
a motion to dismiss a challenge to categorical
exclusions for treatment for gender dysphoria in a
health insurance plan); Prescott v. Rady Children’s
Hosp. of San Diego, 265 F. Supp. 3d 1090, 1098
(S.D. Cal. 2017) (denying defendant hospital’s
motion to dismiss gender identity discrimination
complaint under Section 1557 because Department
regulations were not in effect at the time of the
alleged discrimination, holding the claim of
discrimination was grounded in the plain language
of the statute).
9 78 FR 46558 (Aug. 1, 2013). Responses are
available for public inspection at https://
www.regulations.gov/docket/HHS-OCR-2013-0007/
comments.
10 80 FR 54171 (Sept. 8, 2015). The 2015 NPRM
received roughly 2,160 comments, which are
available for public inspection at https://
www.regulations.gov/docket/HHS-OCR-2015-0006/
comments.
3 20
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Federal Register / Vol. 87, No. 149 / Thursday, August 4, 2022 / Proposed Rules
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 healthrelated insurance and other healthrelated coverage, including a ban on
categorical exclusions of gendertransition-related care in health
insurance coverage and other healthrelated 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
11 81
FR 31375 (May 18, 2016).
the Proposed Rule at § 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).
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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
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
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
15 81
FR 31389, 31390.
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.’’
17 81 FR 313756, 31378, 31430, 31466.
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),
16 See
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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
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
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
§ 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
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
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).
25 84 FR 27846 (June 14, 2019).
26 140 S. Ct. 1731 (2020).
27 84 FR 27853–55, 27856–57.
28 84 FR 27848–49.
29 See e.g., 84 FR 27857–58.
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operations of an entity principally
engaged in providing or administering
health insurance or health-related
coverage (former § 92.4); the
requirement to designate a responsible
employee to carry out a covered entity’s
responsibilities under Section 1557
(former § 92.7(a)); the requirement to
adopt grievance procedures (former
§ 92.7(b)); notice and tagline
requirements (former § 92.8); the
approach to accepting disparate impact
claims with respect to allegations of sex
discrimination (former § 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 healthrelated or scientific objective (former
§ 92.101(b)(3)(iv)); the requirement for a
covered entity to take reasonable steps
to provide meaningful access to each
LEP individual (former § 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
§ 92.207); the coverage of certain
employee health benefit programs
(former § 92.208); the prohibition of
discrimination on the basis of
association (former § 92.209); reference
to compensatory damages for Section
1557 violations to the extent such
damages are available under underlying
Federal civil rights statutes (former
§ 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 § 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
30 85 FR 37160 (June 19, 2020) (‘‘After
considering public comments, in this final rule, the
Department revises its Section 1557 regulations
. . . as proposed, with minor and primarily
technical corrections.’’). The 2019 NPRM received
roughly 155,960 comments, which are available for
public inspection at https://www.regulations.gov/
docket/HHS-OCR-2019-0007.
31 140 S. Ct. 1731 (2020).
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preamble language that was inconsistent
with the Supreme Court’s Bostock
opinion.32
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.
3. May 10, 2021 Notification of
Interpretation (‘‘Bostock Notification’’)
On May 10, 2021, the Department
publicly announced, consistent with the
32 85
FR 37178–37180.
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 § 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).
33 Id.
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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.
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.
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
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.’’).
37 Neese v. Becerra, No. 2:21–cv–00163–Z (N.D.
Tex. Aug. 25, 2021); Am. Coll. of Pediatricians v.
Becerra, No. 1:21–cv–00195 (E.D. Tenn. Aug. 27,
2021); Christian Emp’rs All. v. EEOC, No. 21–cv–
00195 (D.N.D. Oct. 18, 2021).
38 No. 2:21–cv–00163–Z, 2022 WL 1265925, at
*14 (N.D. Tex. Apr. 26, 2022).
39 No. 21–cv–00195, 2022 WL 1573689, at *9
(D.N.D. May 16, 2022).
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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 genderaffirming 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
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
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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
40 U.S. Dep’t of Health & Human Servs., HHS
Notice and Guidance on Gender Affirming Care,
Civil Rights, and Patient Privacy (Mar. 2, 2022),
https://www.hhs.gov/sites/default/files/hhs-ocrnotice-and-guidance-gender-affirming-care.pdf.
41 Id. at 2.
42 Letter from Kristen Clarke, Assistant Att’y Gen.,
Civil Rights Div., U.S. Dep’t of Justice, to State
Att’ys Gen. (Mar. 31, 2022), https://
www.justice.gov/opa/press-release/file/1489066/
download.
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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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.
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
45 The term ‘‘health coverage’’ generally refers to
a ‘‘[l]egal entitlement to payment or reimbursement
for your health care costs, generally under a
contract with a health insurance company, a group
health plan offered in connection with
employment, or a government program like
Medicare, Medicaid, or the Children’s Health
Insurance Program (CHIP).’’ Glossary: Health
coverage, HealthCare.gov, https://
www.healthcare.gov/glossary/health-coverage/ (last
visited June 15, 2022).
46 E.g., Memorandum from Pamela S. Karlan,
Principal Deputy Assistant Att’y Gen., to Fed.
Agency Civil Rights Dirs. & Gen. Counsels (Mar. 26,
2021) [hereinafter Karlan Memo], https://
www.justice.gov/crt/page/file/1383026/download;
86 FR 32637 (June 22, 2021) (U.S. Dep’t of Educ.,
notice of interpretation).
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decision-making and in telehealth
services.
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.
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
47 45 CFR 84.61 (adopting the procedural
provision of Title VI).
48 Id. § 86.71 (adopting the procedural provision
of Title VI).
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includes discrimination on the basis of
sexual orientation and gender identity.
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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
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
49 A list of stakeholder groups and notes from
these listening sessions and written materials
provided during or after the listening sessions are
attached to the docket of this proposed rule as a
supplemental material at federalregister.gov.
50 45 CFR 92.3(a)(2).
51 42 U.S.C. 18116(a) (emphasis added).
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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
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 health52 45
CFR 92.3(a)(2)–(3) (emphasis added).
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).
55 45 CFR 92.3(c).
53 85
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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.
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
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
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).
61 86 FR 7023, 7023–24 (Jan. 25, 2021).
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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.
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 gendernonconforming 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
62 86
FR 27984; see also Karlan Memo, supra note
46.
63 85
FR 37160, 37178–79 (June 19, 2020).
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,
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64 85
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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
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
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.
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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.
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.
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
71 45
CFR 92.2.
§ 84.7(b).
73 Id. § 86.8(b).
72 Id.
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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.
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
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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) § 84.4 (504); § 86.31 (Title IX); and
§ 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 § 92.2, which does not identify
specific, prohibited discriminatory actions. See 85
FR 37160, 37200 (June 19, 2020); 45 CFR 92.2.
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.
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more effectively and expeditiously end
the emergency for everyone.78
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.
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
78 See, e.g., Ann Lee & Sheila David, Ensuring
Equitable Access to Vaccines, Stan. Soc. Innovation
Rev., Jun. 29, 2021, https://ssir.org/articles/entry/
ensuring_equitable_access_to_vaccines#.
79 See, e.g., E.O. 13985, 86 FR 7009 (2021); E.O.
13988, 86 FR 7023 (2021); E.O. 13995, 86 FR 7193
(2021); Memorandum on Redressing Our Nation’s
and the Federal Government’s History of
Discriminatory Housing Practices and Policies
(2021), https://www.whitehouse.gov/briefing-room/
presidential-actions/2021/01/26/memorandum-onredressing-our-nations-and-the-federalgovernments-history-of-discriminatory-housingpractices-and-policies/; Memorandum on
Condemning and Combating Racism, Xenophobia,
and Intolerance Against Asian Americans and
Pacific Islanders in the United States (2021),
https://www.whitehouse.gov/briefing-room/
presidential-actions/2021/01/26/memorandumcondemning-and-combating-racism-xenophobiaand-intolerance-against-asian-americans-andpacific-islanders-in-the-united-states/; E.O. 14012,
86 FR 8722 (2021); E.O.14031, 86 FR 29675 (2021);
E.O. 14035, 86 FR 34593 (2021); E.O. 14041, 86 FR
50443 (2021); E.O.14045, 86 FR 51581 (2021); and
other Presidential Actions.
80 156 Cong. Rec. S1842 (daily ed. Mar. 23, 2010),
https://www.congress.gov/congressional-record/
2010/03/23/senate-section/article/S1821-6.
81 U.S. Dep’t of Health & Human Servs., Office of
Minority Health, Minority Population Profiles,
https://www.minorityhealth.hhs.gov/omh/
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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 nonHispanic white people, Puerto Ricans
have a low birth weight rate that is
almost twice that of non-Hispanic white
people.84
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
browse.aspx?lvl=2&lvlid=26 (last visited Nov. 9,
2021).
82 Alexander Adia et al., Health Conditions,
Outcomes, and Service Access Among Filipino,
Vietnamese, Chinese, Japanese, and Korean Adults
in California, 2011–2017, 110 a.m. J. of Pub. Health
520 (2020), https://ajph.aphapublications.org/doi/
full/10.2105/AJPH.2019.305523.
83 Id.
84 U.S. Dep’t of Health & Human Servs., Office of
Minority Health, Profile: Hispanic/Latino
Americans https://minorityhealth.hhs.gov/omh/
browse.aspx?lvl=3&lvlid=64 (last visited Nov. 19,
2021).
85 The U.S. Census does not classify the Indian
Health Service as health coverage. U.S. Dep’t of
Health & Human Servs., Assistant Sec’y for Policy
& Evaluation, Office of Health Policy, Issue Brief:
Health Insurance Coverage and Access to Care for
American Indians and Alaska Natives: Current
Trends and Key Challenges, p. 1 (July 22, 2021),
aspe-aian-health-insurance-coverage-ib.pdf
(hhs.gov).
86 U.S. Dep’t of Health & Human Servs., Assistant
Sec’y for Policy & Evaluation, Office of Health
Policy, Issue Brief: The Remaining Uninsured:
Geographic and Demographic Variation, p. 1 (Mar.
23, 2021), https://aspe.hhs.gov/sites/default/files/
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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
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
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
private/pdf/265286/Uninsured-Population-IssueBrief.pdf.
87 Id. at p. 8.
88 U.S. Dep’t of Health & Human Servs., Agency
for Healthcare Research & Quality, 2021 National
Healthcare Quality and Disparities Report Executive
Summary, pp. ES–3, D–3–D–51 (Dec. 2020), https://
www.ahrq.gov/sites/default/files/wysiwyg/research/
findings/nhqrdr/2021qdr.pdf.
89 Social determinants of health are the
conditions in the environments where people are
born, live, learn, work, play, worship, and age that
affect a wide range of health, functioning, and
quality-of-life outcomes and risks. Social
Determinants of Health, Healthy People 2030, U.S.
Dep’t of Health & Human Servs., Office of Disease
Prevention & Health Promotion, https://health.gov/
healthypeople/objectives-and-data/socialdeterminants-health (last visited January 21, 2022).
90 U.S. Dep’t of Health & Human Servs., Agency
for Healthcare Research & Quality, 2019 National
Healthcare Quality and Disparities Report Executive
Summary, p. 7 (Dec. 2020), https://www.ahrq.gov/
sites/default/files/wysiwyg/research/findings/
nhqrdr/2019qdr-final-es-cs061721.pdf.
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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
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
91 Donna L. Hoyert, U.S. Dep’t of Health & Human
Servs., Ctrs. for Disease Control & Prevention,
Maternal Mortality Rates in the United States (Feb.
2022), https://www.cdc.gov/nchs/data/hestat/
maternal-mortality/2020/E-stat-Maternal-MortalityRates-2022.pdf.
92 Id.
93 Marian F. MacDorman et al., Racial and Ethnic
Disparities in Maternal Mortality in the United
States Using Enhanced Vital Records, 2016–2017,
111 a.m. J. Pub. Health 1673, 1671 (2021), https://
ajph.aphapublications.org/doi/10.2105/
AJPH.2021.306375.
94 The White House Briefing Room, A
Proclamation on Black Maternal Health Week, 2021
(April 13, 2021), www.whitehouse.gov/briefingroom/presidential-actions/2021/04/13/aproclamation-on-black-maternal-health-week-2021/
;see also, The White House Briefing Room, A
Proclamation on Black Maternal Health Week, 2022
(April 8, 2022), https://www.whitehouse.gov/
briefing-room/presidential-actions/2022/04/08/aproclamation-on-black-maternal-health-week-2022/
.
95 The White House Briefing Room, FACT
SHEET: Biden-Harris Administration Announces
Initial Actions to Address the Black Maternal
Health Crisis (Apr. 13, 2021), www.whitehouse.gov/
briefing-room/statements-releases/2021/04/13/factsheet-biden-harris-administration-announcesinitial-actions-to-address-the-black-maternalhealth-crisis./
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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
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 wellbeing of individuals of color. For
example, Black people who experience
96 Jennifer L. Heck et al., Maternal Mortality
Among American Indian/Alaska Native Women: A
Scoping Review. 30 J. of Women’s Health 220, 229
(2021), https://www.liebertpub.com/doi/epdf/
10.1089/jwh.2020.8890.
97 Id. at 226.
98 Kelly M. Hoffman et al., Racial Bias in Pain
Assessment and Treatment Recommendations, and
False Beliefs About Biological Differences Between
Blacks and Whites, 113 Proc. of the Nat’l Acad. of
Sci. 4296, 4301 (2016), https://doi.org/10.1073/
pnas.1516047113.
99 Michael Sun et al., Negative Patient
Descriptors: Documenting Racial Bias in the
Electronic Health Record, 41 Health Affairs 203,
211 (2022), https://www.healthaffairs.org/doi/pdf/
10.1377/hlthaff.2021.01423.
100 Liz Hamel et al., The Kaiser Family Found.,
The Undefeated Survey on Race and Health, p. 4
(2020), https://files.kff.org/attachment/Report-RaceHealth-and-COVID-19-The-Views-and-Experiencesof-Black-Americans.pdf.
101 Id. at 5.
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racism were more likely to experience
deteriorations in health that contribute
to premature death, including increased
risk of inflammation and chronic
illness.102
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 postdischarge 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
102 Jamila Taylor, The Century Found., Racism,
Inequality, and Health Care for African Americans,
p. 6 (2019), https://production-tcf.imgix.net/app/
uploads/2019/12/19172443/AfAmHealth_Jamila_
PDF.pdf.
103 Jason Espinoza et al., How Should Clinicians
Respond to Language Barriers that Exacerbate
Health Inequity?, 23 a.m. Med. Ass’n J. of Ethics
E109 (2021) (LEP patients and families in the U.S.
‘‘face barriers to health service access, experience
lower quality care, and suffer worse health
outcomes’’), https://journalofethics.ama-assn.org/
sites/journalofethics.ama-assn.org/files/2021–02/
cscm3–2102.pdf.
104 Id.; see also Leah S. Karliner et al., Convenient
Access to Professional Interpreters in the Hospital
Decreases Readmission Rates and Estimated
Hospital Expenditures for Patients with Limited
English Proficiency, 55 Med. Care 199 (2017),
https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC5309198/.
105 Espinoza, supra note 103.
106 Wooksoo Kim et al., Barriers to Healthcare
Among Asian Americans, 25 Soc. Work in Pub.
Health 286, 289 (2010), https://
www.tandfonline.com/doi/pdf/10.1080/
19371910903240704?needAccess=true.
107 Id.
108 U.S. Dep’t of Health & Human Servs., Agency
for Healthcare Research & Quality, Executive
Summary: Improving Patient Safety Systems for
Patients with Limited English Proficiency (Sept.
2020), https://www.ahrq.gov/health-literacy/
professional-training/lepguide/execsummary.html#what.
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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
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
109 Id.
110 Espinoza,
supra note 103, at 110.
e.g., Glenn Flores et al., Errors of Medical
Interpretation and Their Potential Clinical
Consequences: A Comparison of Professional
Versus Ad Hoc Versus No Interpreters, 5 Annals of
Emerg. Med. 545 (Nov. 1, 2012), https://
pubmed.ncbi.nlm.nih.gov/22424655/; Ali Labaf et
al., The Effect of Language Barrier and NonProfessional Interpreters on the Accuracy of
Patient-Physician Communication in Emergency
Department, 3 Adv. J. Emerg. Med., June 6, 2019,
at p. 4, https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC6789075/pdf/AJEM-3-e38.pdf.
112 U.S. Dep’t of Health & Human Servs., Agency
for Healthcare Research & Quality, supra note 108.
113 See Lala Tanmoy Das et al., Addressing
Barriers to Care for Patients with Limited English
Proficiency During the COVID–19 Pandemic, Health
Affairs Blog (July 29, 2020), https://
www.healthaffairs.org/do/10.1377/
hblog20200724.76821/full/.
114 What Health Issues or Conditions Affect
Women Differently than Men?, U.S. Dep’t of Health
& Human Servs., Nat’l Inst. of Child Health &
Human Dev., https://www.nichd.nih.gov/health/
topics/womenshealth/conditioninfo/
howconditionsaffect (last visited Mar. 15, 2022).
115 Brad Greenwood et al., Patient-Physician
Gender Concordance and Increased Mortality
Among Female Heart Attack Patients, 115 Proc.
Nat’l Acad. Sci. 8569, 8574 (2018), https://
www.pnas.org/doi/epdf/10.1073/pnas.1800097115.
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physician or by a male physician who
has had more exposure to female
patients and female physicians.116
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
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 nonLGBTQI+ 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
111 See,
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116 Id.
117 Anke Samulowitz et al., ‘‘Brave Men’’ and
‘‘Emotional Women’’: A Theory-Guided Literature
Review on Gender Bias in Health Care and
Gendered Norms Towards Patients with Chronic
Pain, Pain Res. & Mgmt., Feb. 25, 2018, at pp. 1,
9–10, https://downloads.hindawi.com/journals/
prm/2018/6358624.pdf; see also Danielle M.
Wesolowicz et al., The Roles of Gender and
Profession on Gender Role Expectations of Pain in
Health Care Professionals, 11 J. of Pain Res. 1121
(2018), https://www.dovepress.com/
getfile.php?fileID=42642.
118 Samulowitz, supra note 117, at pp. 1, 9.
119 Hilary Daniel et al., Annals of Internal Med.
Position Papers, Lesbian, Gay, Bisexual, and
Transgender Health Disparities: Executive
Summary of a Policy Position Paper from the
American College of Physicians (2015), https://
www.acpjournals.org/doi/full/10.7326/M142482?journalCode=aim.
120 U.S. Dep’t of Health & Human Servs., Ctrs. for
Disease Control & Prevention, HIV Surveillance
Report, 2019; Vol. 32, pp. 19, 24, 46 (2021), https://
www.cdc.gov/hiv/pdf/library/reports/surveillance/
cdc-hiv-surveillance-report-2018-updated-vol32.pdf.
121 Daniel, supra note 119.
122 Id.
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health conditions,123 including
suicidality.124 LGB people are more
likely to acquire a disability at a
younger age than heterosexual
individuals.125
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
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
123 Charlotte Patterson et al., Nat’l Acads. of Sci.,
Eng’g, & Med., Understanding the Well-Being of
LGBTQI+ Populations, p. 298 (2020), https://
doi.org/10.17226/25877.
124 Daniel, supra note 119.
125 Id.
126 What We Know Project, Cornell U., What Does
the Scholarly Research Say About the Effects of
Discrimination on the Health of LGBT People
(2019), https://whatweknow.inequality.cornell.edu/
wp-content/uploads/2019/12/LGBT-DiscriminationPrintable-Findings-121319.pdf.
127 Lesbian, Gay, Bisexual, and Transgender
Health, HealthyPeople.gov, https://
healthypeople.gov/2020/topics-objectives/topic/
lesbian-gay-bisexual-and-transgender-health (last
visited June 8, 2022).
128 Id.; see also Bianca D.M. Wilson et al., The
Williams Inst., UCLA Sch. of Law, Racial
Differences Among LGBT Adults in the US: LGBT
Well-Being at the Intersection of Race (2022),
https://williamsinstitute.law.ucla.edu/wp-content/
uploads/LGBT-Race-Comparison-Jan-2022.pdf.
129 Sharita Gruberg et al., Ctr. for Am. Progress,
The State of the LGBTQ Community in 2020 (2020),
https://www.americanprogress.org/issues/lgbtqrights/reports/2020/10/06/491052/state-lgbtqcommunity-2020/.
130 Sandy E. James et al., Nat’l Ctr. for
Transgender Equality, The Report of the 2015 U.S.
Transgender Survey, p. 97 (2016), https://
transequality.org/sites/default/files/docs/usts/
USTS-Full-Report-Dec17.pdf.
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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
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
131 Id.
at pp. 96–97.
e.g., Chico Harlan, A Small-Town Doctor
Wanted to Perform Surgeries for Transgender
Women. He Faced an Uphill Battle, Wash. Post
(Nov. 11, 2017), https://www.washingtonpost.com/
national/a-small-town-doctor-wanted-to-performsurgeries-for-transgender-women-he-faced-anuphill-battle/2017/11/11/c6073a0a-c3d7-11e7-84bc5e285c7f4512_story.html.
133 Patterson, supra note 123, at p. 292.
134 Laetitia Zeeman & Kay Aranda, A Systematic
Review of the Health and Healthcare Inequalities
for People with Intersex Variance, 17 Int’l J. of
Envtl. Res. & Pub. Health 6533 (2020), https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC7559554/;
Amy Rosenwohl-Mack et al., A National Study on
the Physical and Mental Health of Intersex Adults
in the U.S., 15 PLoS ONE, Oct. 9, 2020, https://
journals.plos.org/plosone/article?id=10.1371/
journal.pone.0240088.
135 U.S. Dep’t of Health & Human Servs.,
Assistant Sec’y for Policy & Evaluation, Office of
Health Policy, Issue Brief: Health Insurance
Coverage and Access to Care for LGBTQ+
Individuals: Current Trends and Key Challenges, p.
4 (June 2021), https://aspe.hhs.gov/sites/default/
files/2021-07/lgbt-health-ib.pdf.
136 Gruberg, supra note 129.
137 The term ‘‘cisgender’’ refers to a person whose
gender identity is the same as the person’s assigned
sex at birth.
138 Wyatt Koma et al., The Kaiser Family Found.,
Demographics, Insurance Coverage, and Access to
132 See,
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people who can access insurance may
nonetheless be denied coverage for
needed services, including genderaffirming 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
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-athome orders and social distancing
Care Among Transgender Adults (2020), https://
www.kff.org/health-reform/issue-brief/
demographics-insurance-coverage-and-access-tocare-among-transgender-adults/.
139 For purposes of this preamble, the term
‘‘gender-affirming care’’ refers to care for
transgender individuals (including those who
identify using other terms, for example, nonbinary
or gender nonconforming) that may include, but is
not necessarily limited to, counseling, hormone
therapy, surgery, and other services designed to
treat gender dysphoria or support gender
affirmation or transition. Gender-affirming care may
also be, but is not necessarily, referred to as
‘‘gender-affirming health services’’ or ‘‘transitionrelated care.’’ The terms ‘‘gender-affirming care’’ or
‘‘transition-related care’’ also include care sought by
individuals with intersex conditions who seek
treatment for gender dysphoria. See World Prof.
Ass’n for Transgender Health, Standards of Care for
the Health of Transsexual, Transgender, and
Gender-Nonconforming People, pp. 68–71 (7th
Version 2012) [hereinafter WPATH Standards],
https://www.wpath.org/media/cms/Documents/
SOC%20v7/SOC%20V7_English2012.pdf?_
t=1613669341 (last visited Feb. 7, 2022).
140 Gruberg, supra note 129.
141 Dustin Nowaskie & Anna Roesler, The Impact
of COVID–19 on the LGBTQ+ Community:
Comparisons Between Cisgender, Heterosexual
People, Cisgender Sexual Minority People, and
Gender Minority People, 309 Elsevier Psychiatry
Res., Jan. 10, 2022, at pp. 1, 3,
www.sciencedirect.com/science/article/pii/
S0165178122000051.
142 Lindsey Dawson et al., Kaiser Family Found.,
The Impact of the COVID–19 Pandemic on LGBT+
People’s Mental Health (2021), https://www.kff.org/
other/issue-brief/the-impact-of-the-covid-19pandemic-on-lgbt-peoples-mental-health/
#:∼:text=LGBT%20people
%20reported%20the%20COVID,rates%20
than%20non%2DLGBT%20people.
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recommendations.143 These youth may
also face familial rejection and related
mental health and other
consequences.144 Compared to nonLGBT+ 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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3. Health Equity and Discrimination
Related to Age
Although the health disparities
discussed above exist in all age groups,
older adults experience unique agerelated 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
143 Ishaan Sachdeva et al., Letter to the Editor:
The Disparities Faced by the LGBTQ+ Community
in Times of COVID–19, 297 Elsevier Psychiatry Res.,
Jan. 14, 2021, https://www.sciencedirect.com/
science/article/pii/S0165178121000226; Laurie A.
Drabble & Michael J. Eliason, Introduction to
Special Issue: Impacts of the COVID–19 Pandemic
on LGBTQ+ Health and Well-Being, 68 J.
Homosexuality 545, 549 (2021), https://
www.tandfonline.com/doi/pdf/10.1080/
00918369.2020.1868182?needAccess=true; Scott
Emory Moore et al., Disproportionate Impact of the
COVID–19 Pandemic on Perceived Social Support,
Mental Health and Somatic Symptoms in Sexual
and Gender Minority Populations, 68 J.
Homosexuality 577, 587 (2021),
www.tandfonline.com/doi/full/10.1080/
00918369.2020.1868184.
144 Sachdeva, supra note 143.
145 Dawson, supra note 142.
146 Nowaskie, supra note 141, at p. 3; see also
Brad Sears et al., Williams Inst., UCLA Sch. of L.,
The Impact of the Fall 2020 COVID–19 Surge on
LGBT Adults in the U.S., p. 10 (2021), https://
williamsinstitute.law.ucla.edu/wp-content/uploads/
COVID-LGBT-Fall-Surge-Feb-2021.pdf.
147 Drabble, supra note 143, at 548.
148 David Burnes et al., Interventions to Reduce
Ageism Against Older Adults: A Systematic Review
and Meta-Analysis, 109 Am. J. of Pub. Health, e1,
e9 (2019), https://doi.org/10.2105/
AJPH.2019.305123.
149 Why Ageism in Health Care Is a Growing
Concern, RegisCollege.edu, https://
online.regiscollege.edu/blog/why-ageism-in-healthcare-is-a-growing-concern/ (last visited Apr. 20,
2022).
150 Judith Graham, ‘They Treat Me Like I’m Old
and Stupid’: Seniors Decry Health Providers’ Age
Bias, Kaiser Health News (Oct. 20, 2021), https://
khn.org/news/article/ageism-health-care-seniorsdecry-bias-inappropriate-treatment/.
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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
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
151 Id.
152 Stephanie E. Rogers et al., Discrimination in
Healthcare Settings is Associated with Disability in
Older Adults: Health and Retirement Study, 2008–
2012, 30 J. Gen. Intern. Med., 1413, 1420 (2015),
https://doi.org/10.1007/s11606–015–3233–6.
153 U.S. Dep’t of Health & Human Servs., Ctrs. for
Disease Control & Prevention, COVID–19 Mortality
Overview, Provisional Death Counts for
Coronavirus Disease 2019, https://www.cdc.gov/
nchs/covid19/mortality-overview.htm (last visited
Feb. 16, 2022).
154 U.S. Dep’t of Health & Human Servs., Ctrs. for
Medicare & Medicaid Servs., The Impact of COVID–
19 on Medicare Beneficiaries in Nursing Homes,
https://www.cms.gov/medicare-covid-19-nursinghome-analysis (last visited Mar. 15, 2022).
155 Id.
156 Id.
157 Id.
158 See, e.g., Fangli Geng et al., Daily Nursing
Home Staffing Levels Highly Variable, Often Below
CMS Expectations, 38 Health Affairs 1095, 1099
(2019), https://doi.org/10.1377/hlthaff.2018.05322.
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47835
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
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
159 Michelle M. Doty et al., Commonwealth Fund,
How Discrimination in Health Care Affects Older
Americans, and What Health Systems and Providers
Can Do (2022), https://doi.org/10.26099/yffm-2x15.
160 Id.
161 Id.
162 Minorities and Women Are at Greater Risk for
Alzheimer’s Disease, U.S. Dep’t of Health & Human
Servs., Ctrs. for Disease Control & Prevention,
https://www.cdc.gov/aging/publications/features/
Alz-Greater-Risk.html (last visited Mar. 15, 2022).
163 Id.
164 Alzheimer’s Ass’n, Special Report: Race,
Ethnicity and Alzheimer’s in America, p. 72 (2021),
https://www.alz.org/media/Documents/alzheimersfacts-and-figures-special-report.pdf.
165 Id.
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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
Additionally, the relationship
between health disparities and the
ability of low-income populations to
access safe, healthy homes is welldocumented. 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
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
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
166 Maria Trent et al., The Impact of Racism on
Child and Adolescent Health, 144 Am. Acad. of
Pediatrics, Aug. 1, 2019, https://
publications.aap.org/pediatrics/article/144/2/
e20191765/38466/The-Impact-of-Racism-on-Childand-Adolescent.
167 U.S. Dep’t of Health & Human Servs., Office
of the Surgeon Gen., The Surgeon General’s Call to
Action to Promote Healthy Homes (2009), https://
www.ncbi.nlm.nih.gov/books/NBK44192/pdf/
Bookshelf_NBK44192.pdf.
168 Health Effects of Lead Exposure, U.S. Dep’t of
Health & Human Servs., Ctrs. for Disease Control &
Prevention, https://www.cdc.gov/nceh/lead/
prevention/health-effects.htm (last visited Mar. 15,
2022).
169 See, e.g., Eric M. Roberts et al., Assessing
Child Lead Poisoning Case Ascertainment in the
US, 1999–2010, 139 Pediatrics, May 2017, https://
publications.aap.org/pediatrics/article/139/5/
e20164266/38761/Assessing-Child-Lead-PoisoningCase-Ascertainment; Who is Vulnerable to
Childhood Lead Poisoning, Tracking California,
https://www.trackingcalifornia.org/childhood-leadpoisoning/who-is-vulnerable-to-childhood-leadpoisoning (last visited Mar. 15, 2022).
170 See, e.g., Roberts, supra note 169; Who is
Vulnerable to Childhood Lead Poisoning, supra
note 169.
171 See, e.g., Valerie L. Forman-Hoffman et al.,
Disability Status, Mortality, and Leading Causes of
Death in the United States Community Population,
53 Med Care 346 (2015), https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC5302214/;
Gloria L. Krahn et al., Persons with Disabilities as
an Unrecognized Health Disparity Population, 205
Am. J. Pub. Health S198 (Apr. 2015), https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC4355692/;
2020 Topics and Objectives: Disability and Health,
HealthyPeople.gov, https://www.healthypeople.gov/
2020/topics-objectives/topic/disability-and-health
(last visited Nov. 10, 2021); Elham Mahmoudi &
Michelle Meade, Disparities in Access to Health
Care Among Adults with Physical Disabilities:
Analysis of a Representative National Sample for a
Ten-Year Period, 8 Disability Health J. 182 (2015),
https://pubmed.ncbi.nlm.nih.gov/25263459/.
172 Debra L. Brucker & Andrew J. Houtenville,
People with Disabilities in the United States, 96
Archives of Physical Medicine and Rehabilitation
771 (2015), https://doi.org/10.1016/
j.apmr.2015.02.024.
173 Nat’l Council on Disability, Enforceable
Accessible Medical Equipment Standards: A
Necessary Means to Address the Health Care Needs
of People with Mobility Disabilities, p. 7 (2021),
https://ncd.gov/sites/default/files/Documents/NCD_
Medical_Equipment_Report_508.pdf.
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4. Health Equity and Discrimination
Related to Disability
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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
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
174 Lisa I. Iezzoni et al., Physicians’ Perceptions
of People with Disability and Their Health Care, 40
Health Affairs 297 (2021), https://
www.healthaffairs.org/doi/10.1377/
hlthaff.2020.01452. See also, Lisa I. Iezzoni et al.,
US Physicians’ Knowledge About the Americans
with Disabilities Act and Accommodation of
Patients with Disability, 41 Health Affairs 96 (2022),
https://www.healthaffairs.org/doi/abs/10.1377/
hlthaff.2021.01136.
175 Kenneth A. Gerhart et al., Quality of Life
Following Spinal Cord Injury: Knowledge of
Attitudes of Emergency Care Providers, 24 Annals
of Emergency Med. 807 (1994), https://
www.annemergmed.com/article/S01960644(94)70318-3/fulltext; David Carlson et al., Nat’l
Disability Rights Network, Devaluing People with
Disabilities: Medical Procedures that Violate Civil
Rights, pp. 17, 23, 28, 42–43, 49, 54 (2012), https://
www.ndrn.org/wp-content/uploads/2012/05/
Devaluing-People-with-Disabilities.pdf; Laura
VanPuymbrouck et al., Explicit and Implicit
Disability Attitudes of Healthcare Providers, 65
Rehab. Psychology 101 (2020), https://
pubmed.ncbi.nlm.nih.gov/32105109/.
176 Andre
´ s J. Gallegos, Misperceptions of People
with Disabilities Lead to Low-Quality Care: How
Policy Makers Can Counter that Harm and Injustice,
Health Affairs Blog (Apr. 1, 2021), https://
www.healthaffairs.org/do/10.1377/
hblog20210325.480382/full/.
177 2020 Topics and Objectives: Disability and
Health, HealthyPeople.gov, https://
www.healthypeople.gov/2020/topics-objectives/
topic/disability-and-health (last visited Nov. 10,
2021).
178 Kenton J. Johnson et al., Ambulatory Care
Access and Emergency Department Use for
Medicare Beneficiaries With and Without
Disabilities, 40 Health Affairs 910 (2021), https://
www.healthaffairs.org/doi/full/10.1377/
hlthaff.2020.01891.
179 Id.
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compared to female beneficiaries of the
same age reporting no disability.180
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
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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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
180 U.S. Dep’t of Health & Human Servs., Ctrs. for
Medicare & Medicaid Servs., Medicare Current
Beneficiary Survey (2013), https://www.cms.gov/
About-CMS/Agency-Information/OMH/Downloads/
Data-Highlight-ADA–2017.pdf.
181 Caroline Signore et al., The Intersection of
Disability and Pregnancy: Risks for Maternal
Morbidity and Mortality. 30 J. of Women’s Health
147, 153 (2021), https://doi.org/10.1089/
jwh.2020.8864.
182 Sabrina Epstein et al., New Obstacles and
Widening Gaps: A Qualitative Study of the Effects
of the COVID–19 Pandemic on U.S. Adults with
Disabilities, 14 Disability & Health J. 101103 (2021),
https://doi.org/10.1016/j.dhjo.2021.101103.
183 U.S. Dep’t of Health & Human Servs. & U.S.
Dep’t of Justice, Guidance on ‘‘Long Covid’’ as a
Disability Under the ADA, Section 504, and Section
1557 (July 26, 2022), https://www.hhs.gov/about/
news/2021/07/26/hhs-doj-issue-guidance-on-longcovid-and-disability-rights.html.
184 Civil Rights and COVID–19, U.S. Dep’t of
Health & Human Servs., Office for Civil Rights,
https://www.hhs.gov/civil-rights/for-providers/civilrights-covid19/ (last updated July 26,
2021); Bulletin, U.S. Dep’t of Health & Human
Servs., Office for Civil Rights, Civil Rights, HIPAA,
and the Coronavirus Disease 2019 (Mar. 28, 2020),
https://www.hhs.gov/sites/default/files/ocr-bulletin3-28-20.pdf.
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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.
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III. Nondiscrimination in Health
Programs and Activities
Subpart A—General Provisions
Purpose and effective date (§ 92.1)
Proposed § 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 § 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
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
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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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 (§ 92.2)
Proposed § 92.2 addresses the
application of this regulation. The
Department proposes in § 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.’’
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
188 Id.
18116(a) (emphasis added).
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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.
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 § 92.4.
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 § 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
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.
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
191 85
FR 37160, 37169 (June 19, 2020).
Keisler-Starkey & Lisa N. Bunch,
U.S. Dep’t of Commerce, U.S. Census Bureau,
Health Insurance Coverage in the United States:
2019, p. 4 (2020), https://www.census.gov/content/
dam/Census/library/publications/2020/demo/p60271.pdf.
192 Katherine
189 Id.
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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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
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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).
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
193 42
U.S.C. 18116(a).
194 Id.
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HHS to incorporate any of the Title IX
exceptions into its regulatory scheme.195
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 sexbased 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
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’’’).
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).
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particular circumstances—namely,
where ‘‘the application of [Title IX’s
nondiscrimination mandate] would not
be consistent with the religious tenets of
such organization.’’ 202
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
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).
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-cv05583 (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
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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
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
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
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.
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).
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).
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‘‘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.
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.
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
211 85
FR at 37208.
U.S.C. 18116(a).
213 Id. § 18116.
214 Id. 18116(a) (emphasis added).
212 42
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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 motherdaughter activities; and beauty pageantbased 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 nonreligiously 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
215 81
FR 31375, 31380 (May 18, 2016).
e.g., Maryam Guiahi et al., Patient Views
on Religious Institutional Health Care, 2 JAMA
Network Open, Dec. 27, 2019, at p. 2, https://
pubmed.ncbi.nlm.nih.gov/31880794/ (discussing
growing religious ownership of health care entities
in the context of whether U.S. adults consider
religious affiliation when selecting health care
facilities); Michael Booth, SCL Health to Merge with
Intermountain Health, Creating Not-For-Profit
Hospital Giant in West, The Colorado Sun (Sept. 16,
2021), https://coloradosun.com/2021/09/16/
hospital-merger-scl-health-colorado/.
216 See,
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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.
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 § 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.
Applying the existing Federal
conscience and religious freedom laws
217 See, e.g., Coleman Drake et al., Market Share
of US Catholic Hospitals and Associated
Geographic Network Access to Reproductive Health
Services, Jama Network Open, Jan. 29, 2020, https://
jamanetwork.com/journals/jamanetworkopen/
fullarticle/2759762 (research study examining the
impact and growth of Catholic health care entities
on the provision of reproductive health care in the
United States); Harris Meyer, Most Catholic
Hospitals Don’t Disclose Religious Care
Restrictions, Modern Healthcare, Mar. 15, 2019,
https://www.modernhealthcare.com/operations/
most-catholic-hospitals-dont-disclose-religiouscare-restrictions.
218 See, e.g., Gonzales v. O Centro Espı´rita
Beneficente Unia˜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)).
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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.
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 (§ 92.3)
Proposed § 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
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.
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).
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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
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
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
223 See,
e.g., 42 U.S.C. 12201(a).
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).
226 See 28 CFR pt. 35, app. A, B, C.
224 29
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asserting rights under Federal
conscience or religious freedom laws.
These would include statutory
protections under RFRA and the CoatsSnowe Amendment,227 the Church
Amendments,228 section 1303 of the
ACA,229 section 1553 of the ACA,230
and the Weldon Amendment.231
Under the 2016 Rule, former
§ 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 § 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 CoatsSnowe 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 § 92.302.
Definitions (§ 92.4)
Proposed § 92.4 contains proposed
definitions, which is the same approach
taken in the 2016 Rule at former § 92.4.
227 42
U.S.C. 238n.
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,
§ 507(d)(1) (Mar. 15, 2022).
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).
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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.
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;
235 28
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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.
Particular definitions of note are
included below.
Federal financial assistance. We
propose to include the definition of
Federal financial assistance found in
former § 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.
We propose to include a clause to
clarify the Federal financial assistance
236 45 CFR 155.20 (defining ‘‘Exchange’’ and
‘‘Federally-facilitated Exchange’’); § 155.100
(providing for establishment of an Exchange by a
State).
237 81 FR 31375, 31379 (May 18, 2016); 85 FR
37160, 37170 (June 19, 2020).
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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
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 costsharing 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,
238 45
CFR 86.2(g)(1)(ii).
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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
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
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
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).
241 Section 1412 (a)–(c) of the ACA, codified at 42
U.S.C. 18082(a)–(c).
242 Id.
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 costsharing reduction payments) (Oct. 12, 2017),
https://www.hhs.gov/sites/default/files/csrpayment-memo.pdf.
244 Id.
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financial assistance under this proposed
rule similar to the advance payments of
the premium tax credit.
Similarly, the Department plays a role
in providing or administering passthrough 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 passthrough 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
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 pass245 Section 1332(a)(3) of the ACA, codified at 42
U.S.C. 18052(a)(3).
246 Section 1332(a) of the ACA, codified at 42
U.S.C. 18052(a). States with approved waivers have
specific terms and conditions (STCs) that the state
must also comply with all applicable Federal
statutes relating to nondiscrimination, including
Section 1557. See e.g., Ctrs. for Medicare &
Medicaid Servs., approval of Colorado’s extension
application for a section 1332 State Innovation
Waiver, STC 4 (Aug. 13, 2021), https://
www.cms.gov/files/document/1332-co-extensionapproval-letter-stcs.pdf.
247 See Section 1332(a)(3) of the ACA, codified at
42 U.S.C. 18052(a)(3), and implementing
regulations at 31 CFR 33.122, 45 CFR 155.1322.
248 31 CFR 33.122; 45 CFR 155.1322; 86 FR 53412
(Sept. 27, 2021).
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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.
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 § 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
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,
249 42
U.S.C. 18052(a)(3).
45 CFR 92.4.
251 45 CFR 92.3(b), (c) (emphasis added).
250 Former
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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.
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 healthrelated 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.
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
252 81
FR 31385.
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).
253 S.
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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.
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
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
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’’).
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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health insurance and other healthrelated 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 healthrelated 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
By including a nondiscrimination
provision in Title I of the ACA, a title
of the health care law that
predominantly addresses access to and
the design of health insurance and other
health-related coverage, Congress
demonstrated an intent to apply the
non-discrimination provision to health
insurance issuers that receive financial
support from the Federal Government.
Private health insurance issuers play a
critical role in ensuring that people are
able to receive care within the current
health care system. Issuers exercise
significant control over enrollees’ ability
to access their health care by strongly
influencing which providers they see,
which hospitals they visit, and which
treatments or medications they
receive.259 Indeed, a recent district court
opinion on this issue found that, by
virtue of being the ‘‘gatekeeper’’ of the
plaintiff’s health care, a health plan
qualified as a ‘‘ ‘health program’ that
Congress intended to rid of
discrimination.’’ 260 This proposed rule
is consistent with that reading.
We note that the 2016 Rule included
group health plans 261 as among the
entities that were categorically covered
for all of their operations. We propose
to not explicitly include group health
plans in the non-exhaustive list of
entities identified in proposed
paragraph (b). Although we still
consider group health plans to be
principally engaged in providing or
administering health programs or
activities described in paragraph (a),
many group health plans themselves are
not recipients of Federal financial
assistance (as opposed to the employer
or plan sponsor offering the group
health plan or the third party
administrator administering the group
health plan), so inclusion of group
health plans on the list may be
confusing. That said, if the Department
receives a complaint against a group
health plan, we will evaluate the facts
on a case-by-case basis to determine
whether the group health plan is a
covered entity subject to this part.
We note that even if the Department
determines that a group health plan is
not covered under this part, other
entities that contract with a group
health plan or a sponsor of a group
health plan may be covered entities. For
example, recipient health insurance
issuers principally engaged in providing
258 42 U.S.C. 18022(b)(4)(B)–(C) (in defining
essential health benefits, the Secretary of HHS must
‘‘take into account the health care needs of diverse
segments of the population, including women,
children, persons with disabilities, and other
groups,’’ and ‘‘not make coverage decisions . . . or
design benefits in ways that discriminate against
individuals because of their age, disability, or
expected length of life’’); 18031(c)(1)(A) (criteria for
qualified health plans require plans to ‘‘not employ
marketing practices or benefit designs that have the
effect of discouraging the enrollment in such plan
by individuals with significant health needs’’);
300gg (prohibiting discriminatory premium rates by
limiting rating factors to only include family size,
geographic rating area, age, and tobacco use);
300gg–4 (prohibiting discrimination against
individual participants and beneficiaries based on
health status by prohibiting establishment of rules
for eligibility (including continued eligibility) based
on the following health-status-related factors: (1)
Health status; (2) Medical condition (including both
physical and mental illnesses); (3) Claims
experience; (4) Receipt of health care; (5) Medical
history; (6) Genetic information; (7) Evidence of
insurability (including conditions arising out of acts
of domestic violence); (8) Disability; (9) Any other
health status-related factor determined appropriate
by the Secretary).
259 Additionally, many health insurance issuers
are directly involved in the provision of care
through administration of a health maintenance
organization (HMO). An HMO is a health insurance
plan that usually limits coverage to care from
doctors who work for or contract with the HMO.
260 Fain, 545 F. Supp. 3d at 342 (holding that
defendant health plan was a ‘‘health program or
activity’’ for purposes of Section 1557 jurisdiction).
261 ‘‘Group health plan’’ is defined as ‘‘an
employee welfare benefit plan to the extent that the
plan provides medical care (as defined in paragraph
(2) and including items and services paid for as
medical care) to employees or their dependents (as
defined under the terms of the plan) directly or
through insurance, reimbursement, or otherwise.
Such term shall not include any qualified small
employer health reimbursement arrangement (as
defined in section 9831(d)(2) of Title 26).’’ 29 U.S.C.
1191b(a)(1); see also 42 U.S.C. 300gg–91(a).
‘‘Employee welfare benefit plan’’ is defined as ‘‘any
plan, fund, or program which was heretofore or is
hereafter established or maintained by an employer
or by an employee organization, or by both, to the
extent that such plan, fund, or program was
established or is maintained for the purpose of
providing for its participants or their beneficiaries,
through the purchase of insurance or otherwise, (A)
medical, surgical, or hospital care or benefits, or
benefits in the event of sickness, accident,
disability, death or unemployment, or vacation
benefits, apprenticeship or other training programs,
or day care centers, scholarship funds, or prepaid
legal services, or (B) any benefit described in
section 186(c) of this title (other than pensions on
retirement or death, and insurance to provide such
pensions).’’ 29 U.S.C. 1002(1).
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or administering health insurance
coverage would be covered for health
insurance they provide to a fullyinsured group health plan and also for
third party administrator activities that
they are responsible 262 for providing in
a self-funded group health plan.263 The
Department will evaluate the facts on a
case-by-case basis to determine whether
other entities that contract with a group
health plan are covered entities subject
to this part. Further, though a group
health plan may not be covered under
Section 1557, it may still be subject to
other Federal nondiscrimination
requirements. For example, group
health plans and health insurance
issuers offering non-grandfathered
group or individual health insurance
coverage are prohibited from
establishing any rule for eligibility,
benefits, or premiums or contributions
that discriminates based on any health
factor.264
We seek comment on the
circumstances under which a group
health plan might receive funds that
could be considered Federal financial
assistance from the Department,
including the type and prevalence of
funds received that could be considered
Federal financial assistance under this
part.
Finally, we emphasize that proposed
paragraph (b) is not intended to serve as
an exhaustive list of those entities HHS
believes would qualify as principally
engaged in the provision or
administration of health programs or
activities described in paragraph (a). For
example, we propose to expressly refer
to hospitals but not to refer to other
common names, such as medical
centers, for the same or similar entities.
Similarly, we propose not to expressly
include hospital systems or healthcare
systems, even though in many instances
they will fall within the scope of
262 See, e.g., Tovar v. Essentia Health, 857 F.3d
771, 778 (8th Cir. 2017) (holding that a third party
administrator could be liable under Section 1557
for damages arising from discriminatory terms in a
self-funded employer-provided health plan if the
third party administrator provided the employer
with a discriminatory plan document,
notwithstanding the fact that the employer
subsequently adopted the plan and maintained
control over its terms).
263 See discussion infra under proposed § 92.207
on application to third party administrators.
264 45 CFR 147.110 (HHS); 29 CFR 2590.715–2705
(Department of Labor); 26 CFR 54.9815–2705
(Department of the Treasury). We note that
grandfathered and non-grandfathered group health
plans and health insurance issuers offering health
insurance coverage in connection with a group
health plan are prohibited from establishing any
rule for eligibility, benefits, or premiums or
contributions that discriminates based on any
health factor pursuant to 45 CFR 146.121 (HHS); 29
CFR 2590.702 (Department of Labor); 26 CFR
54.9802–1 (Department of the Treasury).
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paragraph (b). For example, under
proposed (b), the rule could cover all of
the operations of a non-profit healthcare
system operating five hospitals,
depending on the specific facts. HHS
will evaluate the facts, on a case-by-case
basis, to determine whether an entity
falls within the scope of paragraph (b)’s
categorical coverage. We invite
comments on whether it is important to
add any other entities to the list in (b)
in order to further clarify coverage.
Machine translation. We propose to
define ‘‘machine translation’’ as
automated translations, without the
assistance of or review by a qualified
human translator, that are text-based
and provide instant translations
between various languages, sometimes
with an option for audio input or
output. This is in contrast to human
translation, which is context-based and
captures the intended meaning of the
source. This definition is based on
literature addressing the use of machine
translation in the clinical setting, which
we believe captures the automated
translations that are being used in the
health care setting.265 We seek comment
on the adequacy of this definition.
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Assurances Required (§ 92.5)
This proposed rule would retain the
requirement of the 2016 and 2020 Rules
for recipients to submit assurances of
compliance to the Department. One
method that the Federal Government
uses to ensure civil rights compliance is
to require covered entities to submit
assurances of compliance when
applying for Federal financial
assistance. The assurances and related
certification documents remind covered
entities of their civil rights obligations
and can also assist the Department in
pursuing an independent contract claim
for enforcement of nondiscrimination
requirements.266
Specifically, proposed § 92.5 is the
same as § 92.4 of the 2020 Rule. In
proposed paragraph (a), each entity
applying for Federal financial
assistance, each issuer seeking
certification to participate in a Health
Insurance Exchange, and each state
seeking approval to operate a State
Exchange is required to submit an
assurance that its health programs and
activities will be operated in
compliance with Section 1557, Title VI,
265 Gudeeshpal Randhawa et al., Using Machine
Translation in Clinical Practice, 59 Can. Fam.
Physician 328 (2013), https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC3625087/
pdf/0590382.pdf.
266 See, e.g., Dep’t of Justice, Guidelines for the
Enforcement of Title VI, Civil Rights Act of 1964,
28 CFR 50.3, pt. I.B.1 (listing various ‘‘[p]ossibilities
of judicial enforcement,’’ including suits to enforce
contractual assurances).
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Title IX, Section 504, and the Age Act.
The duration of obligation (proposed
paragraph (b)), and covenants language
(proposed paragraph (c)) adopt the
corresponding requirements found in
the Section 504 regulation at 45 CFR
84.5.
Remedial Action and Voluntary Action
(§ 92.6)
The Department proposes to include
requirements regarding remedial and
voluntary action, which would reinstate
former § 92.6 in the 2016 Rule. The 2020
Rule repealed former § 92.6, stating that
it was duplicative and overlapped with
existing civil rights laws and
regulations, and therefore would cause
confusion about the responsibilities of
covered entities.267 The regulations
implementing Title IX, Section 504, and
the Age Act do require a covered entity
to take voluntary action upon a
determination that the entity engaged in
discriminatory conduct.268 The
Department believes that, rather than
causing confusion, proposed § 92.6
clarifies that Section 1557 also requires
covered entities that have engaged in
discriminatory conduct with respect to
their health programs and activities in
violation of this part to take voluntary
actions to remediate the effects of such
discriminatory conduct. Where a
covered entity is required to take
remedial actions under Title VI, Section
504, Title IX, or the Age Act, such
actions would likely satisfy the remedial
actions required by proposed § 92.6.
Designation and Responsibilities of a
Section 1557 Coordinator (§ 92.7)
Proposed § 92.7(a) requires covered
entities with 15 or more employees to
designate at least one employee to serve
as a Section 1557 coordinator (Section
1557 Coordinator) to coordinate their
efforts to comply with and carry out the
covered entity’s responsibilities under
Section 1557 and this part with regard
to their health programs and activities.
The 2016 Rule similarly required
covered entities of this size to designate
a compliance coordinator for Section
1557 at former § 92.7. We newly
propose to permit covered entities to, as
appropriate, assign one or more
designees to carry out some of the
responsibilities of the Section 1557
Coordinator. The 2016 Rule did not
include this provision, and we include
it here in recognition that some covered
entities may want or need to spread the
duties of the Section 1557 Coordinator
over multiple staff. However, the
85 FR 37160, 37162 (June 19, 2020).
CFR 86.3(a)–(b) (Title IX); § 84.6(a)–(b)
(Section 504); § 91.48 (Age Act).
Section 1557 Coordinator must retain
ultimate oversight for ensuring
coordination with the covered entity’s
compliance.
In 2020, the Department repealed the
requirement for each covered entity
with 15 or more employees to designate
a Section 1557 Coordinator or
‘‘designated employee,’’ reasoning that
to the extent that the implementing
regulations for the referenced statutes
‘‘have responsible employee and
grievance procedures, they are sufficient
for enforcement of Section 1557.’’ 269
We believe that a designated Section
1557 Coordinator will help ensure
covered entities comply with the
requirements of Section 1557.
Additionally, a designated Section 1557
Coordinator will better allow covered
entities to resolve potential grievances
as accurately and efficiently as possible,
to the benefit of individuals seeking care
as well as the covered entity.
The Department recognizes that
covered entities with 15 or more
employees may have retained their
Section 1557 Coordinators required by
the 2016 Rule even though the 2020
Rule does not require covered entities to
do so. Under proposed § 92.7, those
covered entities that have retained their
Section 1557 Coordinators need not
appoint a new one, though the existing
Section 1557 Coordinator would be
responsible for the responsibilities
outlined in proposed paragraph (b).
The implementing regulations for
Section 504 and Title IX require covered
entities to designate a responsible
employee to coordinate the covered
entity’s civil rights compliance, and the
Title VI and Age Act regulations do not
explicitly include such a
requirement.270 A covered entity that
has already designated a responsible
employee pursuant to the Section 504 or
Title IX regulations may assign that
individual to coordinate the covered
entity’s efforts to comply with Section
1557, provided that the scope of the
individual’s responsibilities is modified
to include all prohibited bases of
discrimination included in Section 1557
and other duties as required. Like the
2016 Rule, proposed § 92.7(a)
standardizes the requirement for
covered entities that employ more than
15 people to designate a Section 1557
Coordinator.
At proposed paragraph (b), we
provide a list of responsibilities of the
Section 1557 Coordinator. The 2016
Rule did not include a similar
provision. The Department proposes to
267 See
269 85
268 45
270 45
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FR 37204.
CFR 84.7(a) (Section 504); § 86.8(a) (Title
IX).
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include a list of responsibilities to assist
covered entities in developing a
position description for the Section
1557 Coordinator and to identify the
provisions over which Coordinators
must have direct responsibility.
Proposed responsibilities include, at a
minimum, that the covered entity
ensure that the Section 1557
Coordinator: (1) receives, reviews, and
processes grievances filed under the
grievance procedure as set forth in
proposed § 92.8(c); (2) coordinates the
covered entity’s recordkeeping
requirements as set forth in proposed
§ 92.8(c); (3) coordinates effective
implementation of the covered entity’s
language access procedures as set forth
in proposed § 92.8(d); (4) coordinates
effective implementation of the covered
entity’s effective communication
procedures as set forth in proposed
§ 92.8(e); (5) coordinates the covered
entity’s procedures for providing
reasonable modifications for individuals
with disabilities in accordance with
proposed § 92.8(f); and (6) coordinates
training of relevant employees as set
forth in proposed § 92.9, including
maintaining the required
documentation.
We seek comment on this
requirement, including whether OCR
should require covered entities with
fewer than 15 employees to designate a
Section 1557 Coordinator and, if so,
whether there should be a requisite
number of employees or whether all
covered entities should be required to
designate a Section 1557 Coordinator.
We are particularly interested in hearing
from smaller covered entities who have
a civil rights coordinator about whether
they believe there is a benefit to having
such a dedicated staff member, and any
associated costs or burdens. We further
seek comment on whether the
enumeration of responsibilities of the
Section 1557 Coordinator is beneficial
and sufficiently comprehensive. We also
seek comment on how the Department
can support Section 1557 Coordinators,
including through the provision of
training, so that they understand their
duties, the protections afforded by
Section 1557, and the rationale for both.
Policies and Procedures (§ 92.8)
Proposed § 92.8 would require
covered entities to develop and
implement written policies and
procedures that are designed to facilitate
compliance with the requirements of
this part. The Department recognizes
that, taken alone, the implementing
regulations for the statutes referenced in
Section 1557 may require entities to
undertake different processes depending
on the alleged basis of discrimination.
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This rulemaking provides for more
consistency regardless of whether an
allegation of discrimination in a covered
health program or activity is based on
race, color, national origin, sex, age, or
disability—or some combination
thereof. The 2020 Rule fails to account
for claims of discrimination in health
programs and activities that are alleged
to have occurred based on multiple
protected bases. The Department
believes that establishing procedural
requirements across nondiscrimination
bases is important because it benefits
the public and covered entities, and it
streamlines OCR’s enforcement scheme.
For the public, providing consistent
regulatory procedural requirements
across nondiscrimination bases
recognizes the potential for complaints
alleging discrimination on multiple
bases (e.g., sex and race). Covered
entities would gain clarity with respect
to their regulatory procedural
requirements without any confusion as
to whether different provisions apply
depending on the protected basis. For
example, there are currently questions
as to whether or not the 2020 Rule
requires covered entities to have a
responsible employee and grievance
procedure to address issues of sex
discrimination, or if that is only
required to the extent that it would be
required under Title IX (i.e., whether the
health program and activity must also
be an education program or activity to
trigger the requirement).
This proposed section would require
each covered entity, in its health
programs and activities, to adopt and
implement a nondiscrimination policy,
grievance procedures (for covered
entities employing 15 or more persons),
language access procedures, auxiliary
aids and services procedures, and
procedures for reasonable modifications
for individuals with disabilities
(collectively, ‘‘Section 1557 Policies and
Procedures’’). We recognize that the
covered entities vary significantly in
size, nature of business, and location
and accordingly recognize that each
covered entity’s Section 1557 Policies
and Procedures may vary. OCR is
committed to supporting covered
entities as they develop policies and
procedures and is planning to provide
sample documents on the Department’s
website. Given the prevalence of
covered entities with fewer than 15
employees that provide health care
services to a significant volume of
patients, the Department highly
encourages such covered entities to
implement Section 1557 Policies and
Procedures based on the sample
documents that will be available on the
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agency website. The Department
underscores that covered entities with
fewer than 15 employees would still be
prohibited from discriminating in health
programs and activities under Section
1557, even if those entities are not
required to adopt grievance procedures,
or to hire a Section 1557 Coordinator,
under this proposed rulemaking.
The Department’s goal is to address
potential compliance issues and help
resolve civil rights concerns at an early
stage, avoiding the need for an OCR
investigation. The Department has also
heard from a range of stakeholders that
it is important to include proactive
measures to increase covered entities’
knowledge of their responsibilities
under Section 1557. The proposed
complementary civil rights policies and
procedures advance these objectives.
This proposed requirement is also
informed by OCR’s enforcement
experience. It is common that, either
during or following an investigation,
OCR will enter into a voluntary
resolution agreement with a covered
entity that requires the adoption and
implementation of nondiscrimination
policies as well as procedures for
providing auxiliary aids and services
and reasonable modifications for
individuals with disabilities, and
language assistance services for LEP
individuals.271 OCR’s resolution
agreements require these interventions,
in part, because our experience
generally demonstrates that targeting
such interventions at the underlying
271 See, e.g., Voluntary Resolution Agreement
between U.S. Dep’t of Justice, U.S. Dep’t Health &
Human Servs., Office for Civil Rights & William W.
Backus Hosp. (2021), https://www.hhs.gov/civilrights/for-providers/compliance-enforcement/
agreements/vra-between-doj-hhs-ocr-williambackus-hospital/; Voluntary Resolution
Agreement between U.S. Dep’t of Health & Human
Servs., Office for Civil Rights & CHRISTUS Trinity
Mother Frances Health Sys. (2020), https://
www.hhs.gov/sites/default/files/christus-vra.pdf;
Voluntary Resolution Agreement between U.S.
Dep’t of Health & Human Servs., Office for Civil
Rights & Mid-Maryland Musculoskeletal Inst.
(2019), https://www.hhs.gov/sites/default/files/
MMI-vra.pdf; https://www.hhs.gov/sites/default/
files/uconn-vra.pdf; Voluntary Resolution
Agreement between U.S. Dep’t of Health & Human
Servs., Office for Civil Rights & Pa. Dep’t of Human
Servs. (2019), https://public3.pagefreezer.com/
content/HHS.gov/31-12-2020T08:51/https://
www.hhs.gov/sites/default/files/hhs-padhs-vra.pdf;
Voluntary Resolution Agreement between U.S.
Dep’t of Justice, U.S. Dep’t Health & Human Servs.,
Office for Civil Rights & Univ. of Vt. Med. Ctr.
(2017), https://www.hhs.gov/sites/default/files/
uvmmc-vra.pdf; Voluntary Resolution Agreement
between U.S. Dep’t of Health & Human Servs.,
Office for Civil Rights & Erie Cty. Dep’t of Soc.
Servs. (2016), https://www.hhs.gov/sites/default/
files/ecdss-vra-final.pdf; Voluntary Resolution
Agreement between U.S. Dep’t of Justice, U.S. Dep’t
Health & Human Servs., Office for Civil Rights & St.
Francis Hosp. & Med. Ctr. (2015), https://
www.hhs.gov/sites/default/files/stfrancishospitalvra.pdf.
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problems can result in covered entities
being better positioned to prevent
discriminatory conduct in the future.
Through the implementation of
Section 1557 Policies and Procedures, a
covered entity’s employees will be
better equipped to provide services in a
nondiscriminatory manner. For
example, an employee will be able to
refer to the covered entity’s official
policy for providing LEP individuals
with language assistance services; such
policies will also be interpreted or
translated as needed, and be available to
an LEP individual or their
representative. Overall, the covered
entity’s policies and procedures should
bring consistency to the covered entity’s
health programs and activities and
improve compliance.
Finally, we note that many health care
providers have adopted policies and
procedures required under OCR’s
existing civil rights authorities and
therefore would only need to review
and update such policies and
procedures rather than creating them
anew. For example, this provision is
consistent with OCR’s civil rights
clearance process required of providers
seeking initial certification or
undergoing a change of ownership to be
certified as a Medicare Part A provider
by CMS.272 In order to obtain a civil
rights clearance, would-be Medicare
Part A providers and businesses must
have nondiscrimination policies and
procedures, including: policies and
procedures to identify and communicate
orally and in writing with LEP
individuals; policies and procedures to
ensure effective communication for
individuals with disabilities, including,
where necessary, the provision of
appropriate auxiliary aids and services;
and a description of how Medicare
providers and applicants make their
program accessible to persons with
disabilities, among other things.273 This
proposed provision would establish
similar obligations. Under this proposed
provision, covered entities may need to
revise any pre-existing policies and
procedures to ensure they, at minimum,
include the proposed required content.
The Department acknowledges that
requiring covered entities to develop
and implement Section 1557 Policies
and Procedures for their health
272 See Civil Rights Clearance for Medicare
Provider Applicants, U.S. Dep’t of Health & Human
Servs., Office for Civil Rights, https://www.hhs.gov/
civil-rights/for-providers/clearance-medicareproviders/ (last updated Oct. 26, 2021).
273 See Technical Assistance for Medicare
Providers and Applicants, U.S. Dep’t of Health &
Human Servs., Office for Civil Rights, https://
www.hhs.gov/civil-rights/for-providers/clearancemedicare-providers/technical-assistance/
(last updated Oct. 27, 2021).
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programs and activities would be a
departure from previous rulemakings,
under which covered entities that
implemented such policies and
procedures did so voluntarily. However,
the Department’s enforcement and
compliance assistance experience
demonstrates that interventions such as
implementing policies and procedures
can result in covered entities being
better positioned to prevent
discriminatory conduct and to better
avoid the risk of an employee providing
services in a discriminatory manner.
Thus, we are proposing the Section
1557 Policies and Procedures
requirement because we believe that the
lack of such a requirement leaves
individuals more susceptible to
discrimination and covered entities
more susceptible to violations.
Specifically, as noted above, we believe
that such a proactive measure will more
effectively increase covered entities’
employees’ knowledge of their
responsibilities under Section 1557. The
Department acknowledges that Section
1557 Policies and Procedures are not a
panacea for eliminating discrimination
in health care; however, we emphasize
that our experience has indicated that
implementing policies and procedures
that are the same or similar to the
proposed Section 1557 Policies and
Procedures helps prevent future
instances of discriminatory conduct.
Proposed paragraph (a) of this section
requires covered entities to implement
written Section 1557 Policies and
Procedures. The policies and
procedures must include an effective
date and be reasonably designed, taking
into account the size, complexity, and
the type of health programs or activities
undertaken by a covered entity, to
ensure compliance with this part.
Proposed paragraph (b) requires each
covered entity to implement a written
nondiscrimination policy that, at
minimum, provides the contact
information for the Section 1557
Coordinator (if applicable) and states
that the covered entity in its health
programs and activities: does not
unlawfully discriminate on the basis of
race, color, national origin (including
limited English proficiency and primary
language), sex (including pregnancy,
sexual orientation, gender identity, and
sex characteristics), age, or disability;
and provides language assistance
services and appropriate auxiliary aids
and services free of charge, when
necessary for compliance with Section
1557 or this part.
Proposed paragraph (c) addresses the
requirements for covered entities with
15 or more employees with regard to
grievance procedures and recordkeeping
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in their health programs and activities,
including ensuring that the grievance
procedure is accessible to LEP
individuals and individuals with
disabilities.
In proposed paragraph (c)(1), OCR is
proposing to require that covered
entities with more than 15 employees
establish written civil rights grievance
procedures. This is similar to the 2016
Rule at former § 92.7, except that we
propose to include a record retention
requirement. The 2020 Rule repealed
former § 92.7 and provided that certain
covered entities need only have a
grievance procedure to the extent the
referenced statutes require it.274 We
believe that the requirement in
proposed paragraph (c)(1) will restore
consistency of requirements for covered
entities that existed under former § 92.7.
It is also responsive to data related to
improving health care visits for
historically marginalized communities,
which indicate that a majority of
patients in these communities desire a
method for submitting grievances to
health care providers so that the
providers can address the patients’
problems.275 Though the referenced
data did not identify whether patients
desired a mechanism to submit
discrimination grievances specifically,
the data support the supposition that,
for patients of color, trust in their health
care providers would increase if these
patients could voice their concerns
directly to their health care providers,
thus, improving these patients’ overall
health care experiences. Accordingly,
the Department’s proposed § 92.8(c)
provides a mechanism for patients to
raise allegations of discrimination
directly to their respective health care
providers. We expect covered entities to
tailor the sample grievance procedure to
fit their different needs for flexibility,
efficiency, and cost effectiveness.
At paragraph (c)(2), we propose that a
covered entity must retain records
related to grievances filed with it that
allege discrimination on the basis of
race, color, national origin, sex, age, or
disability in its health programs and
activities for no less than three (3) years
from the date of the filing of the
274 85 FR 37160, 37204 (Jun. 19, 2020) (‘‘To the
extent that [the referenced statutes’] implementing
regulations have . . . grievance procedures, they
are sufficient for enforcement of Section 1557.’’).
275 Leslie Read et al., The Deloitte Ctr. for Health
Solutions, Rebuilding Trust in Health Care: What
Do Consumers Want—and Need—Organizations to
Do?, p. 3 (2021) (‘‘62% [of surveyed people of color]
want their local hospitals to ensure patients have
a voice to relay their experiences and take action
to address their problems.’’), https://
www2.deloitte.com/content/dam/insights/articles/
US164518_CHS-Equity-trust/DI_Rebuilding-trust-inhealthcare.pdf.
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grievance. The records must include the
grievance; the name and contact
information of the complainant (if
provided by the complainant); the
alleged discriminatory action and
alleged basis (or bases) of
discrimination; the date the grievance
was filed; the grievance resolution; and
any other pertinent information.
Pertinent information includes, to the
extent relevant to a particular
complaint, information related to the
complainant’s national origin (including
limited English proficiency and primary
language), sex (including pregnancy,
sexual orientation, gender identity, or
sex characteristics), etc.
Through its enforcement experience,
OCR has found that obtaining records of
past grievances from covered entities is
an important and informative
component of a thorough investigation,
as it assists OCR in identifying potential
patterns or practices of discrimination
that may not otherwise be apparent
while reviewing a single OCR
discrimination complaint. For example,
if OCR receives a single discrimination
complaint from a person giving birth
alleging discrimination on the basis of
race, OCR could review the grievances
submitted to a covered entity to identify
the presence or absence of any potential
patterns of discrimination against
people giving birth on the basis of race.
Without a requirement to retain
grievances for a period of time, it is
more difficult for OCR to identify
potential patterns or practices of
discrimination. This requirement will
assist OCR not only in identifying the
scope of concern, but also in crafting
appropriate technical assistance and
complaint resolutions.
OCR understands that retaining
grievances for a specified period of time
is already the practice of some covered
entities. This requirement seeks to make
the practice more consistent, thereby
allowing OCR to better identify
potential patterns or practices of
discrimination during complaint
investigations and compliance reviews.
Having access to discrimination
complaints over a period of time will
also allow covered entities to be
proactive in identifying potential
patterns or practices of discrimination,
which will allow them to take corrective
actions, if necessary, before a complaint
is filed with OCR. We believe the threeyear record retention requirement
strikes the right balance between
covered entities’ burden concerns and
the need for access to this vital
information. However, while we
propose to require records to be kept for
three (3) years, nothing in the proposed
rule will prevent covered entities from
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keeping their records for a longer period
of time if the recipient wishes or due to
other legal obligations.276
Proposed paragraph (c)(3) requires
that a covered entity keep confidential
the identity of an individual who has
filed a grievance, except as required by
law or to the extent necessary to carry
out the purposes of this proposed
regulation, including the conduct of any
investigation.
We seek comment on the record
retention requirement, particularly with
regard to patient privacy concerns or
concerns regarding potentially
unauthorized use of information
included in such records. We seek
comment on best practices for record
retention of grievance procedures,
including strategies for ensuring patient
privacy.
Rather than requiring health programs
and activities of the Department to
adopt separate grievance procedures,
the 2016 Rule provided that, for the
Department, the procedures for
addressing complaints of discrimination
under Section 1557 would be deemed
the required grievance procedures under
this section. We decline to reinstate this
approach, as individuals and the
Department’s health programs and
activities can also benefit from a process
for covered entities to address any
potential compliance issues at an earlier
stage and in a less formal manner than
an OCR investigation. However,
individuals may opt not to use a health
program or activity’s grievance
procedure and may elect to file a
complaint with OCR at any time,
regardless of whether the health
program or activity is conducted by a
recipient, the Department, or a Title I
entity.
Proposed paragraph (d) requires
covered entities to develop and
implement written language access
procedures to support compliance with
requirements to take reasonable steps to
provide meaningful access to LEP
individuals in their health programs and
activities under proposed § 92.201.
Given existing requirements to provide
language assistance to LEP individuals
under Title VI and Section 1557,
informed by the Department’s ‘‘2003
Guidance to Federal Financial
Assistance Recipients Regarding Title VI
Prohibition Against National Origin
Discrimination Affecting Limited
English Proficient Persons’’ (HHS LEP
Guidance),277 we anticipate that some
276 For example, the Department of Education
Title IX regulation requires recipients to keep
records related to Title IX sexual harassment
grievances and investigations for a period of seven
(7) years. 34 CFR 106.45(b)(10).
277 68 FR 47311, 47316 (Aug. 8, 2003).
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47849
covered entities may have already
implemented policies and procedures
akin to this requirement. Additionally,
Federal agencies have been required to
have language access procedures since
2000, as provided for in E.O. 13166,278
and the Department itself has a
Language Access Plan.279 This
requirement is also consistent with the
civil rights clearance process required
for Medicare Part A providers, which
requires policies and procedures to
identify and communicate orally and in
writing with LEP individuals.280
We propose that, at a minimum, a
covered entity’s language access
procedures must include information
detailing the contact information for the
Section 1557 Coordinator (if applicable);
how an employee identifies whether an
individual is LEP; how an employee
obtains the services of qualified
interpreters and translators the covered
entity uses to communicate with LEP
individuals; the names of any qualified
bilingual or multilingual staff members;
and a list and the location of any
electronic and written translated
materials the covered entity has, the
languages they are translated into, and
the publication date. We note that
covered entities have a duty to translate
that extends beyond those documents
that have already been translated at the
time this list is made, and the list
should be updated periodically.
Proposed paragraph (e) requires
covered entities to develop and
implement written effective
communication procedures to support
compliance with requirements to take
appropriate steps to ensure that
communications in their health
programs and activities with individuals
with disabilities are as effective as
communications with individuals
without disabilities under proposed
§ 92.202. We propose that, at a
minimum, a covered entity’s effective
communication procedures must
include the contact information for the
Section 1557 Coordinator (if applicable);
how an employee obtains the services of
qualified interpreters the covered entity
uses to communicate with individuals
with disabilities; the names of any
qualified interpreter staff members; and
how to access appropriate auxiliary aids
and services that are necessary for
278 65
FR 50121 (Aug. 16, 2000).
Dep’t of Health & Human Servs.,
Language Access Plan (2013), https://www.hhs.gov/
sites/default/files/open/pres-actions/2013-hhslanguage-access-plan.pdf.
280 Technical Assistance for Medicare Providers
and Applicants, U.S. Dep’t of Health & Human
Servs., Office for Civil Rights, https://www.hhs.gov/
civil-rights/for-providers/clearance-medicareproviders/technical-assistance/ (last
updated Oct. 27, 2021).
279 U.S.
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effective communication. This provision
is similarly consistent with the civil
rights clearance process required for
Medicare Part A providers, which
requires policies and procedures to
ensure effective communication for
individuals with disabilities, including,
where appropriate, the provision of
auxiliary aids and services.281
Proposed paragraph (f) requires
covered entities to develop and
implement written procedures for
making reasonable modifications to
their policies, practices, or procedures
that allow individuals with disabilities
equal opportunity to participate in their
health programs and activities as
required under proposed § 92.205. As
proposed, a covered entity’s reasonable
modification procedures must, at a
minimum, include contact information
for the covered entity’s Section 1557
Coordinator (if applicable); describe the
covered entity’s process for responding
to requests from individuals with
disabilities for changes, exceptions, or
adjustments to a rule, policy, practice,
or service of the covered entity; and the
process for determining whether making
the modification would fundamentally
alter the nature of the service, program,
or activity, including identifying an
alternative modification that does not
result in a fundamental alteration to
ensure the individual with a disability
receives the benefits or services in
question.
We note that the failure to request a
reasonable modification does not always
excuse the covered entity from
providing a reasonable modification to
avoid discrimination on the basis of
disability, as long as it does not result
in a fundamental alteration. For
example, when a covered entity had
knowledge of an individual’s disability
and needs, or when an individual’s
disability and needs are obvious, a
covered entity must provide
modifications in the absence of a
request.282
Proposed paragraph (g) provides that
a covered entity may combine the
281 Technical Assistance for Medicare Providers
and Applicants, U.S. Dep’t of Health & Human
Servs., Office for Civil Rights, https://www.hhs.gov/
civil-rights/for-providers/clearance-medicareproviders/technical-assistance/ (last
updated Oct. 27, 2021).
282 See, e.g., Greer v. Richardson Indep. Sch.
Dist., 472 F. App’x 287, 296 (5th Cir. 2012) (holding
that a ‘‘failure to expressly ‘request’ an
accommodation is not fatal to an ADA claim where
the defendant otherwise had knowledge of the
individual’s disability and needs but took no
action’’); Duvall v. Cty. of Kitsap, 260 F.3d 1124,
1139 (9th Cir. 2001) (‘‘When the plaintiff has alerted
the public entity to his need for accommodation (or
where the need for accommodation is obvious . . .),
the public entity is on notice that an
accommodation is required . . .’’).
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content of the policies and procedures
required by this provision with any
policies and procedures pursuant to
other civil rights statutory protections if
they clearly comply with Section 1557
and the provisions in this part.
The Department encourages covered
entities to include additional
information in their Section 1557
Policies and Procedures to provide
employees the means to ensure
individuals are able to access their
health programs and activities free from
discrimination. For example, covered
entities may consider including
information in their respective Section
1557 Policies and Procedures regarding
service animals, as well as maintaining
civil rights protections during public
health emergencies.
We seek comment on this proposed
provision and whether there may be
alternative measures that the
Department should consider to
proactively prevent discrimination, and
whether they would be more or less
burdensome than what is proposed. We
would particularly welcome comments
from covered entities concerning their
experiences under voluntary resolution
agreements with OCR requiring them to
adopt policies and procedures. We also
invite comment from all covered entities
that have previously implemented or are
currently implementing a
nondiscrimination policy, grievance
procedures, language access procedures,
effective communication procedures, or
reasonable modification procedures;
consumers who interact with covered
health programs and activities; and
community-based organizations that
work with LEP individuals and
individuals with disabilities. We also
seek comment on whether covered
entities employing less than 15 people
should be required to have a grievance
procedure, including the benefits for a
less formal resolution process.
Training (§ 92.9)
To ensure that covered entities
implement Section 1557 Policies and
Procedures in accordance with
proposed § 92.8, proposed § 92.9
requires covered entities to train
relevant employees in their health
programs and activities on their Section
1557 Policies and Procedures. This
proposed section, coupled with § 92.8,
is designed to help covered entities and
their employees take measures to
prevent discrimination by ensuring that
staff are knowledgeable about the
nondiscrimination policy, grievance
procedures, and processes by which to
obtain language assistance services for
LEP individuals and to ensure effective
communication with and provide
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reasonable modifications for individuals
with disabilities.
Proposed paragraph (a) provides a
general requirement that covered
entities train relevant employees of their
health programs and activities on the
Section 1557 Policies and Procedures
required by proposed § 92.8. Given the
diversity of entities covered by this part,
the Department is not prescribing the
specific training methods a covered
entity must use or the nature of a
covered entity’s training program. The
Department notes, however, that the
more thoroughly a covered entity trains
its staff on its Section 1557 Policies and
Procedures, the more likely it is that the
covered entity will successfully provide
services to individuals in a
nondiscriminatory manner and avoid
potential liability for violations of
Section 1557 and this part.
Further, this provision takes into
consideration potential burdens on
covered entities by requiring that only
relevant staff (including, but not limited
to, the Section 1557 Coordinator, if
applicable) be trained, rather than
requiring all staff to be trained. The
Department anticipates that relevant
health program and activity staff will
include those involved in client and
patient interactions, as well as those
involved with drafting, approving, and
funding policies and procedures for
compliance with this part. However,
such aspects of training required by this
section are left to the discretion of the
covered entity. The proposed approach,
which requires training only on the
covered entity’s Section 1557 Policies
and Procedures, is efficient, provides
practical benefits based on each covered
entity’s unique circumstances, and is
less resource intensive than requiring
covered entities to train relevant staff on
all of the regulatory requirements for
Section 1557’s underlying statutes.
Similar to the proposal to require
Section 1557 Policies and Procedures,
the Department believes in the
importance of proactive measures to
prevent and mitigate the potential for
discriminatory conduct in covered
health programs and activities. That is
why the Department proposes to require
training in this rulemaking. OCR
provides public education and outreach
and has found it to be an effective
means to ensure covered entities are
complying with their respective Federal
civil rights obligations. Just as OCR’s
proactive public education and outreach
efforts yield compliance benefits, based
on the Department’s enforcement and
compliance assistance experience we
believe that covered entities’ proactive
Section 1557 Policies and Procedures,
coupled with employee training, will
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yield compliance benefits as well as
improved health outcomes.283
Federal agency technical assistance
materials on language access
consistently highlight the important role
training plays in delivering services
effectively. For example, CMS’ ‘‘Guide
to Developing a Language Access Plan’’
dedicates an entire section to advising
organizations about the importance of
training.284 The Guide provides, in part,
that an organization’s training should
focus on the organizations’ policies and
procedures related to providing
language assistance services. Similarly,
a DOJ assessment and planning tool for
federally conducted and federally
assisted programs included ‘‘training
staff on policies and procedures’’ as one
of the key six steps for developing an
effective language access policy.285
DOJ’s tool provides that ‘‘[t]raining
should explain how staff can identify
the language needs of an LEP
individual, access and provide the
necessary language assistance services,
work with interpreters, request
document translations, and track the use
of language assistance services.’’ 286
The Department believes that a staff
training requirement will increase the
likelihood that covered entities are
prepared to best meet the
communication needs of LEP
individuals and individuals with
disabilities, avoiding potentially critical
delays or denials of care. This is
particularly salient as the nation
addresses the COVID–19 pandemic and
works to prepare for future public
health emergencies. As described above,
the COVID–19 pandemic exposed
barriers to accessing health care for
historically marginalized populations,
including challenges related to
providing testing and vaccination
services in a way that provides
meaningful access to LEP individuals
and is accessible to individuals with
283 See, e.g., John S. Lord, Jr., Health Care
Providers: It’s Not Just Employee Discrimination
Claims—Patients Can Have Discrimination Claims
Too, Nat’l L. Rev. (Feb. 8, 2022) (recommending
‘‘perioding compliance reviews and up-to-date
trainings’’ on civil rights nondiscrimination
requirements to ‘‘help prevent and defend’’ against
patient discrimination claims), https://
www.natlawreview.com/article/health-careproviders-it-s-not-just-employee-discriminationclaims-patients-can-have.
284 U.S. Dep’t of Health & Human Servs., Ctrs. for
Medicare & Medicaid Servs., Guide to Developing
a Language Access Plan, p. 9, https://www.cms.gov/
About-CMS/Agency-Information/OMH/Downloads/
Language-Access-Plan-508.pdf.
285 U.S. Dep’t of Justice, Language Access
Assessment and Planning Tool for Federally
Conducted and Federally Assisted Programs, p. 6
(2011), https://www.lep.gov/sites/lep/files/
resources/2011_Language_Access_Assessment_
and_Planning_Tool.pdf.
286 Id.
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disabilities. For example, many covered
entities required individuals to register
on a website or through an online portal
in order to obtain a COVID–19 test or
vaccine. Websites and portals often
failed to include non-English
registration instructions,287 and some
have been inaccessible to individuals
with disabilities.288
We have previously noted that, when
necessary, OCR enters into voluntary
resolution agreements with covered
entities to resolve concerns about
noncompliance with Federal civil rights
laws, including Section 1557.289 These
voluntary resolution agreements
routinely require covered entities to
develop policies and procedures and
provide employee training on their
policies and procedures because such
actions promote compliance with
Federal civil rights laws. OCR believes
that the development and
287 Joseph R. Fuchs et al., Older Adults with
Limited English Proficiency Need Equitable COVID–
19 Vaccine Access, 69 J. Am. Geriatr. Soc’y. 888,
889 (2021), https://
agsjournals.onlinelibrary.wiley.com/doi/10.1111/
jgs.17069; Rachana Pradham, ‘Press 1 for English’:
Vaccination Sign-Ups Prove Daunting for Speakers
of Other Languages, Kaiser Health News (Mar. 23,
2021), https://khn.org/news/article/press-1-forenglish-vaccination-sign-ups-prove-daunting-forspeakers-of-other-languages/.
288 Press release, U.S. Dep’t of Justice, Justice
Department Secures Settlement with Rite Aid
Corporation to Make Its Online Covid-19 Vaccine
Portal Accessible to Individuals with Disabilities
(Nov. 1, 2021), https://www.justice.gov/usao-mdpa/
pr/justice-department-secures-settlement-rite-aidcorporation-make-its-online-covid-19; Press release,
U.S. Dep’t of Justice, Justice Department Secures
Agreement with Hy-Vee Supermarket Chain to
Make Online COVID–19 Vaccine Registration
Accessible for People with Disabilities (Dec. 1,
2021), https://www.justice.gov/opa/pr/justicedepartment-secures-agreement-hy-vee-supermarketchain-make-online-covid-19-vaccine; Lauren Weber
& Hannah Recht, Covid Vaccine websites Violate
Disability Laws, Create Inequity for the Blind,
Kaiser Health News (Feb. 25, 2021), https://khn.org/
news/article/covid-vaccine-websites-violatedisability-laws-create-inequity-for-the-blind/; Haley
Messenger, Blind Americans Face Roadblocks
Booking Online Vaccine Appointments, NBC News
(Mar. 13, 2021, 6:02 a.m.), https://
www.nbcnews.com/business/consumer/blindamericans-face-roadblocks-booking-online-vaccineappointments-n1260954; Fixing the Problem of
Inaccessible Information from the Beginning,
Equidox, https://equidox.co/blog/fixing-theproblem-of-inaccessible-covid-19-information/ (last
visited June 15, 2022); Elise Young, Vaccine Rollout
Leaves Behind the Blind, Paralyzed, Autistic,
Bloomberg (Mar. 18, 2021, 10:25 a.m.), https://
www.bloomberg.com/news/articles/2021-03-18/
disabled-citizens-left-behind-in-u-s-push-toovercome-pandemic; Maggie Vaughn, Vaccine
Registration websites: Inaccessible to the Blind,
Dubbot: DubBlog (Mar. 10, 2021), https://
dubbot.com/dubblog/2021/vaccine-registrationwebsites-inaccessibile-to-the-blind.html.
289 See Recent Civil Rights Resolution Agreements
& Compliance Reviews, U.S. Dep’t of Health &
Human Servs., Office for Civil Rights, https://
www.hhs.gov/civil-rights/for-providers/complianceenforcement/agreements/ (last updated
June 15, 2022); see also supra note 271.
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47851
implementation of, and training on,
such policies are likely to reduce
discriminatory actions from occurring in
the future and reduce the need for
voluntary resolution agreements.
Proposed paragraph (a) provides a
general requirement that covered
entities train relevant employees of their
health programs and activities on the
civil rights policies and procedures
required by proposed § 92.8.
Proposed paragraph (b) specifies
when covered entities must train
relevant employees on their Section
1557 Policies and Procedures. We
consider relevant employees to be those
who directly encounter or interact with
individuals such as patients, clients,
and members of the public. Employees
are also considered relevant when they
make decisions regarding the services
individuals seek from a covered entity’s
health programs and activities. Under
paragraph (b)(1) covered entities would
be required to train existing relevant
employees on their Section 1557
Policies and Procedures as soon as
practicable, but no later than one (1)
year after the effective date of the Final
Rule. Proposed paragraph (b)(2)
proposes that covered entities train new
relevant employees within a reasonable
period of time after they join a covered
entity’s workforce.
In paragraph (b)(3), we propose to
require covered entities to train relevant
employees whose roles are affected by
material changes to the covered entity’s
Section 1557 Policies and Procedures.
Examples of material changes may
include new contact information for a
covered entity’s Section 1557
Coordinator (if applicable), changing
from one qualified interpreter service
provider to another, acquiring or
discontinuing the use of certain
auxiliary aids and services, such as in
response to changing technology, or
substantive changes to the covered
entity’s process for ensuring effective
communication or for providing
language assistance services. Similar to
paragraph (b)(2), paragraph (b)(3) would
require covered entities to train
employees within a reasonable time
after a material change has been made.
Nothing in the proposed provision
prohibits covered entities from training
their employees on Section 1557
Policies and Procedures more
frequently. For example, covered
entities may include such training in the
existing annual or quarterly training
programs that they require their
employees to complete.
Proposed paragraph (c) requires
covered entities to contemporaneously
document their employees’ completion
of the training required by this section
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in written or electronic form and
maintain said documentation for no less
than three (3) calendar years.
We note that neither the 2016 Rule
nor the 2020 Rule included a training
requirement, though we are aware that
many covered entities already have civil
rights trainings for their employees that
could be modified to comply with this
proposed provision. We seek comment
on the experiences of covered entities in
implementing training such as that
required by proposed § 92.9, examples
of where training made a difference in
compliance, the timing of required
training, whether covered entities
would like the flexibility to include this
required training as part of its existing
annual compliance training, what types
of changes would constitute a material
change such that a covered entity would
need to retrain staff, and the amount of
time for which training records must be
retained. We also seek general comment
on this proposal, including the
effectiveness of civil rights training
programs, the benefits experienced by
covered entity staff and the people they
serve, as well as the costs associated
with the proposed training
requirements.
We further seek comment on whether
the Section 1557 Policies and
Procedures requirements and training
requirements may increase the
likelihood of compliance with the
substantive legal requirements of
Section 1557.
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Notice of Nondiscrimination (§ 92.10)
Proposed § 92.10 requires each
covered entity to provide a notice of
nondiscrimination, relating to its health
programs and activities, to participants,
beneficiaries, enrollees, and applicants
of its health programs and activities,
and members of the public. Notice can
be provided through written translations
or in-language recorded audio or video
clips.
The 2016 Rule required covered
entities to include a nondiscrimination
notice and set of taglines (i.e., a short
non-English statement in appropriate
languages indicating the availability of
language assistance services) in all
‘‘significant publications or significant
communications . . . which may
include patient handbooks, outreach
publications, or written notices
pertaining to rights or benefits or
requiring a response from an
individual’’ in conspicuous physical
locations and online.290 The 2016 Rule
included a separate provision for
‘‘small-sized’’ significant publications
290 81
FR 31375, 31396 (May 18, 2016).
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communications.291 This provision
required covered entities to include a
notice statement in lieu of the full
notice, on small-sized significant
publications and significant
communications like postcards and trifold brochures.292
The 2016 Rule received criticism for
failing to provide a definition of
‘‘significant publications or significant
communications,’’ though it provided
some examples of what would be
considered ‘‘significant.’’ The
Department also received substantial
feedback regarding the financial burden
imposed by the notice and tagline
requirements. Citing these concerns, the
2020 Rule repealed the 2016 Rule’s
provisions on notices and taglines in
their entirety.293
The Department has reviewed
concerns raised in response to the 2016
Rule requirements, as well as those
raised in response to the removal of the
notice and tagline requirements in the
2020 Rule. Although we acknowledge
the additional responsibilities placed on
covered entities through the 2016 Rule
requirements, we believe that the 2020
Rule does not adequately consider some
of the adverse consequences that
individuals incur or the burdens that
the health care system faces without
these notice provisions.294 Therefore,
the Department has concluded that it
should not have eliminated these
provisions in their entirety. To ensure
clarity and reduce confusion, this
proposed rule will address the notice of
nondiscrimination and notice of
availability of language assistance
services and auxiliary aids and services
in separate sections.
Proposed § 92.10(a) requires covered
entities to provide a notice of
nondiscrimination, relating to their
health programs and activities, to
participants, beneficiaries, enrollees,
and applicants of their health programs
and activities, and to members of the
public. Proposed paragraph (a)(1)
provides the required contents of the
notice of nondiscrimination, including
that (i) the covered entity does not
discriminate on the basis of race, color,
national origin (including limited
English proficiency and primary
language), sex (including pregnancy,
sexual orientation, gender identity, or
sex characteristics), age, or disability in
its health programs or activities; (ii) the
291 Former
45 CFR 92.8(g)(1).
covered entity provides reasonable
modifications for individuals with
disabilities, and appropriate auxiliary
aids and services, including qualified
interpreters, for individuals with
disabilities and information in alternate
formats, such as braille or large print,
free of charge and in a timely manner,
when such modifications or aids and
services are necessary to ensure
accessibility and equal opportunity to
participate to individuals with
disabilities; (iii) the covered entity
provides language assistance services,
including electronic and written
translated documents and oral
interpretation free of charge and in a
timely manner, when such services are
necessary to provide meaningful access
to a limited English proficient
individual; (iv) how to obtain from the
covered entity the reasonable
modifications, auxiliary aids and
services, and language assistance
services in paragraphs (a)(1)(ii) and (iii)
of this section; (v) the contact
information for the covered entity’s
Section 1557 Coordinator designated
pursuant to § 92.7 of this part (if
applicable); (vi) the availability of the
covered entity’s grievance procedure
pursuant to § 92.8(c) of this part and
how to file a grievance (if applicable);
(vii) details on how to file a
discrimination complaint with HHS’
Office for Civil Rights; and (viii) how to
access the covered entity’s website, if it
has one, that provides the information
required under paragraph (a)(1) of this
section. OCR is proposing to require a
parenthetical for national origin
discrimination, to include limited
English proficiency and primary
language, to clarify for the public that
these are prohibited forms of
discrimination. For the same reason, a
parenthetical would be required for sex
discrimination, to include pregnancy,
sexual orientation, gender identity, or
sex characteristics.
Proposed § 92.10(a)(2) would provide
specific information on when and where
covered entities must provide the notice
of nondiscrimination. Rather than
requiring entities to include the notice
in ‘‘significant’’ communications, we
propose that covered entities provide
the notice on an annual basis and upon
request. Similar to the 2016 Rule
requirements, we propose that the
notice also be placed at a conspicuous
location on the covered entity’s health
program or activity website,295 if it has
292 Id.
293 85 FR 37160, 37161, 37176, 37228 (June 19,
2020).
294 See, e.g., Nat’l Council of Asian Pacific Ams.,
Comment on Section 1557 NPRM, pp. 3–7 (Aug. 13,
2019), https://www.regulations.gov/comment/HHS–
OCR–2019–0007–145953.
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295 For more information about improving access
to public websites for LEP individuals, see U.S.
Dep’t of Justice, Title VI Interagency Working
Group, Improving Access to Public websites and
Digital Services for Limited English Proficient (LEP)
Persons (Dec. 2021), https://www.lep.gov/sites/lep/
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one, and in clear and prominent
physical locations where it is reasonable
to expect individuals seeking service
from the health program or activity to be
able to read or hear the notice. These
requirements would pose a relatively
low-cost burden for covered entities
while ensuring information regarding
the covered entity’s civil rights
obligations is provided in locations that
are highly visible and visited by
participants and members of the public.
Paragraph (b) proposes that a covered
entity may combine the content of the
notice required by paragraph (a) of this
section with the notices required by
Title VI, Section 504, Title IX, and the
Age Act implementing regulations 296 if
the combined notice clearly informs
individuals of their civil rights under
Section 1557 and this part and meets
the requirements outlined in proposed
paragraph (a)(1).
In drafting these proposed notice
provisions, the Department considered
alternative approaches such as requiring
covered entities to provide notices at
every encounter with a participant or
beneficiary or simply adopting the
approach in the 2016 Rule. The
Department decided against these
approaches, and believes the proposed
provisions emphasize the importance of
notifying individuals of their civil rights
and makes clear the requirements for
notifying individuals about important
civil rights requirements. Further, we
believe this proposal addresses the
burdens raised by covered entities in
response to the 2016 Rule notice
requirements by providing specific
occurrences (annual basis and upon
request) and locations (conspicuous
location on website and prominent
physical location) for when and where
the notice must be provided rather than
the ambiguity caused by the 2016 Rule.
We seek comment on whether the
notice of nondiscrimination
requirement as proposed is practical,
likely to be effective, and responsive to
concerns raised regarding the 2016 and
2020 Rules, including the sufficiency of
the content of the notice and
requirements regarding when and where
covered entities must provide the
notice. In particular, we seek comment
on the best ways to provide an
accessible initial notice to individuals
who may require auxiliary aids and
services for their disabilities and the
best way in which to provide the notice
in a manner accessible to LEP
files/media/document/2021-12/2021_12_07_
website_Language_Access_Guide_508.pdf.
296 45 CFR 80.6(d) (Title VI); § 84.8 (Section 504,
federally assisted); § 85.12 (federally conducted);
§ 86.9 (Title IX); § 91.32 (Age Act).
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individuals. The Department is also
interested in hearing from covered
entities regarding whether they are still
following the 2016 notice requirement,
and the potential burdens and costs of
what is proposed here.
Notice of Availability of Language
Assistance Services and Auxiliary Aids
and Services (§ 92.11)
Proposed § 92.11 requires covered
entities to notify the public of the
availability of language assistance
services and auxiliary aids and services
for their health programs and activities
(‘‘Notice of Availability’’). This
provision is similar to the ‘‘tagline’’
requirement found at former § 92.8 in
the 2016 Rule, but with additional
information required to be included in
the notice. The 2016 Rule required
covered entities to provide ‘‘taglines,’’
short statements written in non-English
languages that indicate the availability
of language assistance services free of
charge, in a variety of languages and
communications.297 The Department
has opted not to use the term ‘‘tagline’’
in this rule because this provision also
now requires a notice of the availability
of auxiliary aids and services.
The 2016 Rule required covered
entities to include ‘‘taglines’’ in at least
the top 15 languages spoken by LEP
individuals in the relevant state or states
in significant publications and
communications and at various
locations.298 To reduce the
administrative burden on covered
entities, OCR translated these
statements into 64 languages and made
the translated statements available to
covered entities.299
The 2020 Rule repealed this
provision, citing costs, confusion, and
waste, but stated that covered entities
are still required ‘‘to provide taglines
whenever such taglines are necessary to
ensure meaningful access by LEP
individuals to a covered program or
activity.’’ 300 Commenters argued the
2019 NPRM’s Regulatory Impact
Analysis (RIA) labeled the impact on
LEP individuals of eliminating notice
and tagline requirements as negligible
without providing an evidentiary
basis 301 and failed to address the costs
beneficiaries would face without these
provisions and the additional costs to
the health care system that could
result.302 We now believe that in
297 Former
45 CFR 92.8.
§ 92.8(d)(1).
299 81 FR 31453.
300 See 85 FR 37160, 37176, 37228, 37241 (June
19, 2020).
301 See id. at 37204.
302 See Nat’l Council of Asian Pacific Ams., supra
note 294, at pp. 3–7; see also 85 FR 37233.
298 Id.
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finalizing the 2020 Rule absent any
‘‘tagline’’ requirement, the Department
did not adequately weigh the concerns
raised by commenters, including the
costs individuals incur or the burdens
the health care system would face
without these requirements.303
Commenters specifically argued that
eliminating ‘‘tagline’’ provisions would
result in fewer safeguards that minimize
health care risks LEP individuals face in
the health care system, including
avoidable hospital readmissions, lower
rates of outpatient follow up, limited
use of preventive services, poor
medication adherence, and lack of
understanding discharge
instructions.304 According to
commenters, these impacts could lead
to higher costs to the health care system,
as LEP individuals are more likely to
experience medical errors due to
communication barriers. The
availability of language assistance
services, on the other hand, is
associated with fewer readmission rates
and fewer malpractice claims.305
Several organizations have sued the
Department for repealing the notice and
tagline provisions of the 2016 Rule. The
lawsuits detail the costs of repealing
these requirements. In the WhitmanWalker case, the plaintiffs, organizations
providing and advocating for health care
services, and individual health care
professionals, alleged that the removed
provisions are critical to ensuring
meaningful access to care.306 The
plaintiffs further argued that removing
the 2016 Rule’s tagline provisions,
‘‘burden[s] private health care and
individual provider plaintiffs, as well as
members of health professional
association plaintiffs, because patients
will come to them sicker due to
inadequate care elsewhere, and more
people may come to them because their
LEP services will remain robust.’’ 307
The plaintiffs also alleged that
eliminating the notice provisions would
make it more difficult for patients ‘‘to
understand their health care rights,
communicate with doctors and other
health care workers, and navigate
complex insurance and medical
303 See
supra note 302.
Nat’l Women’s Law Ctr., Comment on
Section 1557 NPRM, p. 21 (Aug. 13, 2019), https://
www.regulations.gov/comment/HHS-OCR-20190007-149018.
305 See Nat’l P’ship for Women & Families,
Comment on Section 1557 NPRM, p. 16 (Aug. 13,
2019) (citing to Quan K. Lynch, Nat’l Health Law
Program, The High Costs of Language Barriers in
Medical Malpractice, p. 18 (2010)), https://
www.regulations.gov/comment/HHS-OCR-20190007-137897.
306 Whitman-Walker Compl., supra note 205, at p.
67–68.
307 Id. at p. 68.
304 See
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documents with specialized
terminology, and cause an increase in
patients who will delay or not seek care
at all.’’ 308 In Chinatown Services Center
v. U.S. Department of Health & Human
Services, the plaintiffs, communitybased organizations that serve older LEP
adults, similarly alleged that
elimination of the notice and tagline
requirements of the 2016 Rule
undermines access to health care, and
that the elimination was arbitrary and
capricious because HHS did not
consider alternatives to repealing these
protections.309 The Chinatown Service
Center plaintiffs alleged the 2020 Rule
fails to adequately consider the
confusion caused by the removal of
taglines, the impact of the rule change
on access to care and treatment,
individuals’ reliance on taglines, and
frustration with difficulty accessing
health care.310 The complaint alleges
that ‘‘without notice of their rights, LEP
older adults remain in the dark as to
their right to free interpreter services at
a medical appointment or what they can
do when providers wrongly require LEP
individuals to rely on unqualified
informal or family-member
interpreters.’’ 311
The Department has also heard from
covered entities that they are committed
to providing LEP individuals with
language assistance services but
recommend that the Department require
covered entities to provide language
assistance services in a manner that
does not overwhelm enrollees with
redundant paperwork that may be
unnecessary, repetitive, or wasteful.312
After considering concerns raised
through litigation, stakeholder feedback,
and language access complaints OCR
continues to receive, we have
determined that the 2020 Rule’s
approach in eliminating these
provisions in their entirety is
unnecessary and counterproductive. We
believe that the benefits of meaningful
access to LEP individuals, through
notice of the availability of language
access services, outweigh the costs of
implementing the changes set forth in
this NPRM. The 2020 Rule creates
uncertainty and confusion concerning
when language assistance services must
be provided, resulting in higher risk for
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308 Id.
at p. 28.
Chinatown Serv. Ctr. v. U.S. Dep’t of
Health & Human Servs., No. 1:21–cv–00331, pp. 23,
35 (D.D.C. Feb. 5, 2021), ECF No. 1 [hereinafter
Chinatown Serv. Ctr. Compl.].
310 Id. at p. 21.
311 Id. at p. 2.
312 AHIP Recommendations for 1557 Notice and
Tagline Requirements, p. 1 (Nov. 1, 2021). The
document will be attached to the docket of this
proposed rule as a supplemental material at
federalregister.gov.
309 Compl.,
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covered entities while rendering Section
1557 less effective at combatting
discrimination experienced by LEP
individuals. The Department believes
that the provisions set forth in this
NPRM would help restore consistency
in language assistance procedural
requirements and provide certainty to
covered entities and consumers about
what covered entities’ obligations are
and what rights consumers have.
The proposed reinstatement of inlanguage notices is also intended to help
alleviate burdens on covered entities
who primarily serve LEP populations.
LEP individuals often rely on
community-based organizations as the
first line of support when they are
unable to access other systems due to
language barriers. While we recognize
that this reported increase coincides
with the COVID–19 pandemic, we also
believe it highlights the importance
now, more than ever, of providing
notice of the availability of language
assistance services in health programs
and activities. Additionally, we believe
having these services in place now will
help covered entities be better prepared
to serve LEP individuals during any
future public health emergencies that
may arise.
In addition, several commenters to the
2019 NPRM indicated that removing the
2016 Rule’s tagline provisions would
contribute to health disparities. For
example, the National Women’s Law
Center referenced a 2018 poll, which
said approximately 6 in 10 Latino adults
reported having trouble communicating
with their providers due to language or
cultural barriers.313 As a result, the poll
reported that Spanish-speaking LEP
individuals are more likely to report
experiencing worse health outcomes
than Latino individuals who are
monolingual in English or bilingual in
English and Spanish.314 Although the
2020 Rule removed the requirement that
covered entities include ‘‘taglines’’ in
the top 15 languages spoken by LEP
individuals in their state, it maintained
the requirement that covered entities
provide taglines whenever such taglines
are necessary to ensure meaningful
access by LEP individuals to a covered
health program or activity. Yet the 2020
Rule provides limited guidance to
covered entities and consumers on what
covered entities’ obligations are and
what consumers’ rights are. Covered
entities remain without clear guidance
as to when in-language taglines must be
included to help LEP individuals
understand that language services are
313 Nat’l
Women’s Law Ctr., supra note 304, at p.
21.
314 Id.
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available and how to access them. OCR
continues to receive language access
complaints that raise concerns about
entities not providing sufficient taglines.
The proposed ‘‘Notice of Availability’’
requirement, analogous to the 2016 Rule
‘‘tagline’’ requirement, removes existing
ambiguity for covered entities and
would result in increased access to
health programs and activities for LEP
individuals.
While the 2020 Rule preamble raised
concerns about cost and waste, we
believe it failed to strike the right
balance by eliminating these important
provisions altogether given the
considerations discussed above. With
proposed § 92.11, we seek to be
responsive to industry concerns
regarding excessive costs and other
potential burdens to covered entities,
while balancing the importance of
providing LEP individuals notice of the
availability of language assistance
services to eliminate barriers to
accessing quality health care. In this
new provision, we also propose to
require the Notice of Availability to
include a statement regarding the
availability of appropriate auxiliary aids
and services to reduce barriers to access
for individuals with disabilities.
Proposed paragraph (a) requires a
covered entity to provide a notice that,
at minimum, states that the covered
entity provides language assistance
services and appropriate auxiliary aids
and services free of charge in its health
programs and activities, when necessary
for compliance with Section 1557 or
this part. This notice must be provided
to participants, beneficiaries, enrollees,
and applicants of the covered entity’s
health program or activity, and members
of the public. Notice can be provided
through written translations or recorded
audio or video clips.
Proposed paragraph (b) requires the
Notice of Availability to be provided in
English and at least the 15 most
common languages spoken by LEP
individuals of the relevant state or
states, and in alternate formats for
individuals with disabilities who
request auxiliary aids and services to
ensure effective communications. This
standard ensures that a significant
proportion of each state’s particular LEP
population is receiving key information
in the appropriate language. While the
standard of providing the statement in
these ‘‘top 15’’ languages is the same as
that required by the 2016 Rule, we
attempt to alleviate burdens here by
proposing a list of the relevant materials
in which the Notice of Availability must
be included and providing options for
covered entities to allow individuals to
‘‘opt out’’ of receipt of the Notice of
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Availability or to provide
communication to individuals in their
primary language in lieu of a Notice of
Availability. As in 2016, OCR will
provide a sample Notice of Availability
for covered entities to use, as well as the
15 most common non-English languages
spoken by LEP individuals for each state
and territory.
The Department considered including
a population threshold after consulting
the Department of Agriculture’s
Supplemental Food and Nutrition
regulation, which includes requirements
prescribed by the Food Stamp Act 315 to
translate materials in non-English
languages.316 The Department declines
to include the adoption of a population
threshold because of the inconsistent
results that would result in notice
requirements for urban and rural
communities.317 The Department also
considered requiring translation of the
Notice of Availability in the ‘‘top 15’’
languages to the extent that there are at
least 200 LEP speakers for a particular
language in the relevant state or states.
This standard would require fewer
language translations for states such as
Montana (notices in only 11 languages)
and Wyoming (notices in only 4
languages). However, we declined to
institute this alternative so as to not
include an arbitrary cut-off, such as 200
LEP speakers, into the proposed
regulation, and instead provided
covered entities alternatives to the
requirement to provide a Notice of
Availability. We seek comment on this
approach.
Proposed § 92.11(c) requires the
notice be provided on an annual basis
to participants, beneficiaries, enrollees
(including late and special enrollees),
and applicants, and upon request at any
time. Similar to the notice of
nondiscrimination requirement in
proposed § 92.10, the Notice of
Availability would also be required to
be provided at a conspicuous location
on the covered entity’s health program
or activity website, if it has one, and in
clear and prominent physical locations
where it is reasonable to expect
individuals seeking service from the
315 7
U.S.C. 2020(e)(1)(B).
CFR 272.4(b)(2); see also 65 FR 70143–44
(Nov. 21, 2000) (discussing access to households
with language access barriers).
317 See 43 FR 47846, 47849 (Oct. 17, 1978)
(‘‘Although many commenters suggested adoption
of a uniform percentage test, the Department
rejected that concept because it could require
bilingual service in sparsely populated areas where
only two or three households are of a single
language minority. Conversely, in densely
populated low-income areas, hundreds of singlelanguage areas and hundreds of single-language
minority households could be an insufficient
number to meet the percentage test required for
bilingual services.’’).
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health program or activity to be able to
read or hear the notice. This notice must
also be accessible to individuals with
disabilities who require auxiliary aids
and services. These requirements would
pose a relatively low-cost burden for
covered entities and ensure information
about language assistance services is
provided in locations that are highly
visible and visited by members of the
public.
In response to concerns raised by
stakeholders regarding the lack of
specificity in the term ‘‘significant
publications or significant
communications,’’ rather than providing
a general class of documents for which
the notice must be provided (e.g.,
‘‘significant documents’’), we propose in
paragraph (c)(5) to provide a list of
specific electronic and written
communications that must be
accompanied by the Notice of
Availability. After consideration, we
believe this approach is more tailored to
the needs of LEP individuals and
individuals with disabilities when
accessing important information
regarding a range of health programs
and activities and provides the level of
specificity sought by covered entities.
We propose to require the Notice of
Availability to accompany the following
documents: (i) the notice of
nondiscrimination required by proposed
§ 92.10 of this part; (ii) the notice of
privacy practices required by the
implementing regulations for the Health
Insurance Portability and
Accountability Act of 1996 318 (HIPAA)
at 45 CFR 164.520; (iii) application and
intake forms; (iv) notices of denial or
termination of eligibility, benefits, or
services, including Explanations of
Benefits (EOBs), and notices of appeal
and grievance rights; (v)
communications related to a person’s
rights, eligibility, benefits, or services
that require or request a response from
a participant, beneficiary, enrollee, or
applicant; (vi) communications related
to a public health emergency; (vii)
consent forms and instructions related
to medical procedures or operations,
medical power of attorney, or living will
(with an option of providing only one
notice for all documents bundled
together); (viii) discharge papers; (ix)
complaint forms; and (x) patient and
member handbooks.
We considered limiting the
requirement to include the notice of
availability of language assistance
services and auxiliary aids in EOBs to
only those EOBs that notify individuals
of a cost-sharing responsibility. In other
words, an EOB showing that services
318 Public
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47855
have been fully covered and that the
patient has no further financial
responsibility for the service (including
co-payment, co-insurance, disallowed
cost for which a provider may bill the
patient, or other charge) would not
constitute a notice of a denial or
termination of benefits or services, and
therefore would not be required to
include the notice of availability.
However, we determined that the
burden of administering a process to
assess which EOBs fall under the
requirement and then include the notice
only to those EOBs would be more
burdensome than the alternative of
including the notice in all EOBs. We
invite comment as to whether this is the
most appropriate approach, balancing
the burden of providing notices of
availability with all EOBs against the
burdens associated with determining
which EOBs must include the notice.
To further alleviate the potential
burdens of subsection (d), we propose
alternative, optional methods by which
a covered entity may be deemed in
compliance with proposed § 92.11(a).
First, pursuant to proposed paragraph
(d)(1), a covered entity shall be deemed
in compliance with respect to an
individual if the covered entity, on an
annual basis: provides individuals, in
their primary language and through any
appropriate auxiliary aids and services,
the option to opt out of receipt of the
Notice of Availability; does not
condition receipt of any aid or service
on the decision to opt out; informs the
individual of their right to receive the
notice upon request in their primary
language and through any appropriate
auxiliary aids and services, and that
opting out of receiving the notice is not
a waiver of their right to receive
language assistance services and any
appropriate auxiliary aids and services
as required by this part in their primary
language and through any appropriate
auxiliary aid or service; documents, on
an annual basis, the individual’s
decision to opt out; and does not treat
a non-response from an individual as a
decision to opt out. Second, proposed
paragraph (d)(2) provides that a covered
entity shall be deemed in compliance
with this section with respect to an
individual if the covered entity
documents the individual’s primary
language and any appropriate auxiliary
aids and services and either provides all
materials and communications in that
individual’s primary language and
through any appropriate auxiliary aids
and services, or provides the notice
required by § 92.11(a) in that
individual’s primary language and
through any appropriate auxiliary aids
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and services in all communications that
are identified in § 92.11(c)(5).
In drafting these proposed provisions,
the Department considered alternative
approaches, such as requiring covered
entities to provide the Notice of
Availability at every interaction with a
participant or beneficiary, or simply
adopting the approach in the 2016 Rule.
However, the unnecessary duplication
of requiring covered entities to provide
a Notice of Availability at every
interaction with a beneficiary outweighs
any potential benefit, and simply
adopting the approach in the 2016 Rule
would not address confusion regarding
covered entities’ legal obligations
related to the term ‘‘significant
documents’’ or concerns expressed
about financial burden. We also
considered an opt-in approach whereby
covered entities would offer individuals
an opportunity to opt in to receiving a
copy of a covered entity’s Notice of
Availability. However, given the varying
nature of Section 1557 covered entities,
it would be difficult to specify when
covered entities must offer individuals
the opportunity to opt in to receiving its
Notice of Availability. More
importantly, we believe that the
information contained in the proposed
Notice of Availability is indispensable
to the receipt of services free from
discrimination. Accordingly, by
providing an opt-out option, proposed
§ 92.11 attempts to balance the potential
financial burden on covered entities of
providing the Notice of Availability
against the essential need for
individuals to understand their rights
and therefore would limit the burden
without jeopardizing individual access
to information.
The Department believes the
approach in this proposed rule
emphasizes the importance of notifying
individuals of their civil rights and
makes clear the requirements for
notifying individuals about important
civil rights requirements. The
Department also believes the proposed
rule addresses concerns raised by
covered entities in response to the 2016
Rule requirements.
We seek comment on whether the
Notice of Availability requirement as
proposed is practical and responsive to
concerns raised regarding the 2016 and
2020 Rules, including the sufficiency of
the content of the Notice of Availability
and requirements on when and where
covered entities must provide the
notice. We also seek comment as to
whether it adequately addresses the
specific concerns raised regarding the
burdens associated with the 2016 Rule
requirements by providing a list of
specific documents with which the
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Notice of Availability must be provided.
Additionally, we seek comment on how
to best provide the Notice of
Availability to individuals with
disabilities to ensure they know how to
request and receive relevant materials
and documents in formats that meet
their disability-related needs, and
whether covered entities should be
required to provide the Notice of
Availability in sign language. Similarly,
we seek comment on how to best
provide the Notice of Availability to
LEP individuals, including LEP
individuals with disabilities, to ensure
they know how to request and receive
language assistance services and
auxiliary aids and services to provide
meaningful access to relevant materials
and documents. We also seek comment
on whether the list of communications
proposed adequately captures the
documents for which LEP individuals
and individuals with disabilities should
receive the Notice of Availability. We
further seek comment on the anticipated
costs to covered entities of various sizes
to comply with the proposed
requirements.
Data Collection
Commenters on the 2015 NPRM
requested that OCR require covered
entities to collect additional data,
beyond those required by the referenced
statutes and their regulations, on race,
ethnicity, language, sex, gender, gender
identity, sexual orientation, disability,
and age, in part so that such entities
could better plan how to meet the needs
of those populations.319 We considered
including a provision in the rule
requiring covered entities to collect
additional civil rights data given the
vital role data can play in ensuring civil
rights compliance and the fact that such
data remain largely uncollected for
many demographic subgroups. At this
time, however, we are not including
such a provision but are soliciting
feedback and comments on such data
collection to inform a final rule and
OCR’s overall civil rights work.
The COVID–19 pandemic serves as an
example of the importance of access to
data collection in addressing harm at
the earliest possible stages of a public
health emergency in order to provide
effective and lifesaving health care. In
the early days of the COVID–19
pandemic, public health officials lacked
the data necessary to gain a full picture
of how the pandemic was impacting
marginalized communities, prompting
the publication of tools like the COVID
Racial Data Tracker. The COVID Racial
Data Tracker was created out of a
319 81
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collaboration between the COVID
Tracking Project and the Boston
University Center for Antiracist
Research to gather racial and ethnic
demographic data to understand the
outbreak of COVID–19 and protect
vulnerable communities.320 Indeed, as
the COVID–19 pandemic has
highlighted, the lack of demographic
data can make it challenging to
determine where public health
disparities are occurring and where to
allocate resources such as COVID–19
testing and vaccinations.321 These
issues have civil rights implications.
Just as nearly all of the provisions in
this proposed rule benefit Section 1557
covered entities as much as they benefit
the public, a data collection provision
has the potential to benefit state and
local health departments because they
would be able to use the data they
collect to reveal existing health
disparities and proactively allocate and
disseminate the resources necessary to
address public health disparities.
Since the beginning of the COVID–19
pandemic, the Federal Government has
responded with several data collection
resources—which can be used by
Federal, State, territorial, and local
governments alike—to provide a clearer
picture of how COVID–19 is impacting
communities across the country.
Executive Order 13985, ‘‘Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government,’’ established the
Interagency Working Group on
Equitable Data with the goal of
collecting more disaggregated data
across Federal agencies to be better
equipped to measure and advance
equity through the work of every
Federal agency.322 Data that the Federal
Government has recently made available
can continue to be used to reveal and
address long-existing health disparities.
Some examples of health data the
Federal Government is collecting
include those in HHS’ Protect Public
Data Hub,323 which is a secure data
ecosystem for sharing, parsing, housing,
and accessing COVID–19 data; CDC data
320 About the Racial Data Tracker,
covidtracking.com, https://covidtracking.com/race/
about (last visited June 15, 2022).
321 See Tom Simonite, Covid Hits Minorities
Hardest, But Data Often Doesn’t Show It, Wired
Business (Aug. 24, 2020, 7:00 a.m.), https://
www.wired.com/story/covid-hits-minoritieshardest-data-doesnt-show/; Laura Barron-Lopez et
al., Missing Data Veils Coronavirus Damage to
Minority Communities, Politico (June 14, 2020, 7:00
a.m.), https://www.politico.com/news/2020/06/14/
missing-data-veils-coronavirus-damage-to-minoritycommunities-316198.
322 86 FR 7009 (Jan. 25, 2021).
323 HHS Protect Public Data Hub, https://protectpublic.hhs.gov/ (last June 15, 2022).
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on COVID–19 cases and deaths by state
or territory; 324 those in the
HealthData.gov COVID–19 Reported
Patient Impact and Hospital Capacity by
State Timeseries, which provides stateaggregated data for hospital utilization
in a timeseries format; 325 and those in
the HealthData.gov COVID–19
Diagnostic Laboratory Testing Time
Series, which reports COVID–19 test
results from over 1,000 U.S. laboratories
and testing locations, including
commercial and reference laboratories,
public health laboratories, and other
testing locations.326 This is not an
exhaustive list of the Federal
Government’s data collection activities,
but merely identifies some examples of
what has changed since the beginning of
the COVID–19 pandemic.
When considering adding a data
collection provision to this proposed
rule, the Department contemplated what
kind of additional data we might require
covered entities to collect and from
which covered entities the Department
should collect such data. In addition to
race, ethnicity, language, age, and
disability, we considered requiring
covered entities to collect data on sex,
gender, gender identity, and sexual
orientation from patients and health
care providers. Some states and
territories, including California and
Washington, DC, currently require plans
sold on their Health Insurance
Exchanges to collect demographic data
about enrollees’ race and ethnicity, but
not sexual orientation or gender
identity.327 In Colorado, a new state law
will require issuers to offer a
standardized ‘‘Colorado Option’’ plan
on the State Exchange in 2023, which
includes a requirement to offer a
culturally responsive network of
providers.328 Additionally, the state’s
law requires issuers to attempt to collect
demographic data, including race,
ethnicity, disability status, sex, sexual
orientation, and gender identity from
324 United States COVID–19 Cases and Deaths by
State over Time, data.cdc.gov, https://data.cdc.gov/
Case-Surveillance/United-States-COVID-19-Casesand-Deaths-by-State-o/9mfq-cb36 (last updated
June 15, 2022).
325 COVID–19 Reported Patient Impact and
Hospital Capacity by State Timeseries,
HealthData.gov, https://healthdata.gov/Hospital/
COVID-19-Reported-Patient-Impact-and-HospitalCapa/g62h-syeh (last updated June 15, 2022).
326 COVID–19 Diagnostic Laboratory Testing (PCR
Testing) Time Series, HealthData.gov, https://
healthdata.gov/dataset/COVID-19-DiagnosticLaboratory-Testing-PCR-Testing/j8mb-icvb (last
updated June 15, 2022).
327 Markian Hawryluk, Some Physicians Are
Uneasy as Colorado Collects Providers’ Diversity
Data, npr.org (April 25, 2022, 5:00 a.m.), https://
www.npr.org/sections/health-shots/2022/04/25/
1094354537/colorado-doctor-diversity-data.
328 Id.
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their providers and the providers’ front
office staff.329 The Department
understands there may be concerns
related to requiring covered entities to
collect deeply personal data. On one
hand, the access to such data can
provide a clearer picture of disparities
and gaps in patient outcomes and
representation in the provision of care.
On the other hand, some providers and
patients are hesitant to provide data on
their race, sexual orientation, or gender
identity for fear of discrimination.330
The Department recognizes the
challenges associated with requiring
covered entities to collect such data.
The Department believes that rather
than codifying a specific set of data
collection measures within this
rulemaking, the Department—through
OCR—is better positioned to create a
dynamic and responsive civil rights data
collection structure by using its existing
authorities. OCR does have the authority
to request compliance data from covered
entities under its existing civil rights
authorities, which we propose to codify
for purposes of Section 1557 at
proposed § 92.303(a) (incorporating by
reference 45 CFR 80.6 with regard to
recipients and State Exchanges) and
proposed § 92.303(c) (with regard to the
Department and Federally-facilitated
Exchanges). Using our existing
authorities would be similar to the
Department of Education (ED)’s civil
rights data collection process. Since
1968, ED’s Office for Civil Rights has,
without a regulatory standard for a
recurring civil rights data collection,
required its elementary and secondary
education recipients to collect data 331
on the leading civil rights data
indicators related to access and barriers
to an educational opportunity from
early childhood through 12th grade,
disaggregated by race/ethnicity, sex,
disability, and English Learner status.332
By using existing authorities, the
Department believes OCR will have the
flexibility to be responsive to the critical
health-related civil rights issues that
may arise in the future.
We seek comment on this general
approach, including whether covered
329 Id.
330 Id.
331 ED’s current authority to collect data comes
from section 203(c)(1) of the Department of
Education Organization Act (20 U.S.C. 3413(c)(1))
and is informed by the regulations implementing
several of the civil rights statutes that it implements
authorizing collection of data that are necessary to
ensure compliance with civil rights laws within the
jurisdiction of ED’s OCR.
332 20 U.S.C. 3413(c)(1). See also 34 CFR 100.6(b),
§ 104.61, § 106.71; Civil Rights Data Collection:
Frequently Asked Questions, U.S. Dep’t of Educ.,
Office for Civil Rights, https://www2.ed.gov/about/
offices/list/ocr/frontpage/faq/crdc.html (last
modified Apr. 14, 2021).
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entities are already collecting
disaggregated demographic data in their
health programs and activities and, if so,
for which categories of data, through
what systems, and at what cost. We also
seek comment on how a civil rights data
collection requirement could impact
current data collection efforts, either
positively or negatively. We also seek
comment on whether the adoption of a
regulatory standard for a recurring civil
rights data collection would benefit civil
rights enforcement, as well as how
frequently the data should be submitted
to OCR. We also seek comment on
whether the data collection
requirements should vary by type of
entity, as recipients of Federal financial
assistance include a variety of entities,
including state and local agencies,
health insurance issuers, health care
providers, health care facilities and
clinics, hospitals, federally qualified
health centers, and health-related
educational and training programs.
Accordingly, we seek comment on
which types of recipients (if any) should
be covered; if recipients under a certain
size should be exempt from the data
collection requirement, and if so, should
that be based on employee number, the
number of beds (if relevant), or some
other metric; what types of data should
be collected; what definitions should be
used; the potential costs associated with
such a requirement; and the potential
benefits of such a requirement.
Subpart B—Nondiscrimination
Provisions
For the reasons described below,
Subpart B of the proposed rule generally
adopts certain regulatory provisions
regarding specific discriminatory
actions prohibited by the implementing
civil rights statutes referenced in
Section 1557(a): Title VI, Section 504,
Title IX, and the Age Act.
Discrimination Prohibited (§ 92.101)
Proposed § 92.101(a) provides a
general prohibition of discrimination on
the basis of race, color, national origin,
sex, age, or disability under any health
program or activity to which Section
1557 or this part applies and provides
additional detail regarding what
constitutes discrimination on the basis
of sex. Proposed paragraph (b) identifies
some specific forms of prohibited
discrimination.
Proposed paragraph (a)(1) provides
the general prohibitions on
discrimination under Section 1557 by
restating the core objective of Section
1557: ensuring that covered entities do
not discriminate on the basis of race,
color, national origin, sex, age, or
disability against any individual seeking
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to participate in or receive the benefits
of the covered entity’s health program or
activity. Consistent with Federal case
law 333 and existing Federal civil rights
enforcement,334 the Department’s
proposed nondiscrimination protections
prohibit discrimination based upon a
person’s actual or perceived race, color,
national origin, sex, age, or disability.
Proposed paragraph (a)(2) clarifies
that discrimination on the basis of sex
includes discrimination on the basis of
sex stereotypes; sex characteristics,
including intersex traits; pregnancy or
related conditions; sexual orientation;
and gender identity.
The proposed inclusion of ‘‘sex
stereotypes’’ codifies the Supreme
Court’s holding in Price Waterhouse v.
Hopkins that discrimination on the
basis of sex stereotypes is a form of sex
discrimination.335 As the Court there
333 See Fogleman v. Mercy Hosp., 283 F.3d 561,
572 (3d Cir. 2002) (employee of hospital employer
may pursue retaliation claim even if employer’s
perception that employee was Muslim is factually
incorrect); EEOC v. WC&M Enters., 496 F.3d 393,
400–01 (5th Cir. 2007) (national origin harassment
of an Indian Muslim employee included harassment
based on the employer’s perception that he was an
Arab Muslim); Glenn v. Brumby, 663 F.3d 1312,
1319 (11th Cir. 2011) (‘‘An individual cannot be
punished because of his or her perceived gendernonconformity.’’) (emphasis added); Jones v. UPS
Ground Freight, 683 F.3d 1283 (11th Cir. 2012)
(employer may still be liable for harasser’s use of
epithets associated with an ethnic or racial minority
different than that of the plaintiff employee); Estate
of Lance v. Lewisville Indep. Sch. Dist., 743 F.3d
982, 991 (5th Cir. 2014) (‘‘. . . [section] 504’s reach
extends not only to individuals who in fact have
a disability, but also to individuals who are
regarded as having a disability (whether or not that
perception is correct)’’); but cf. El v. Max Daetwyler
Corp., 451 F. App’x 257 (4th Cir. 2011) (per curiam
opinion affirmed district court’s order granting
employer’s motion to dismiss because Title VII does
not ‘‘contain an explicit provision for the protection
of persons who are merely perceived to be a part
of a protected class’’).
334 See U.S. Equal Emp’t Opportunity Comm’n,
EEOC Enforcement Guidance on National Origin
Discrimination, n.16 (Nov. 18, 2016), https://
www.eeoc.gov/laws/guidance/national-originguidance.cfm#ftn16 (Title VII prohibits employer
actions that have the purpose or effect of
discriminating against persons because of their real
or perceived race, national origin, or association
with a particular religion) (emphasis added);
Housing Discrimination and Persons Identified as
Lesbian, Gay, Bisexual, Transgender, and/or Queer/
Questioning (LGBTQ), U.S. Dep’t of Hous. & Urban
Dev., https://www.hud.gov/program_offices/fair_
housing_equal_opp/housing_discrimination_and_
persons_identifying_lgbtq (last updated Feb. 1,
2022) (‘‘Persons who identify as LGBTQ and believe
they have experienced housing discrimination
because of their actual or perceived sexual
orientation or gender identity can assert their rights
under the Fair Housing Act by filing a complaint
with HUD.’’) (emphasis added); Race and National
Origin Discrimination Frequently Asked Questions,
U.S. Dep’t of Educ., https://www2.ed.gov/about/
offices/list/ocr/frontpage/faq/race-origin.html (last
modified Jan. 1, 2020) (‘‘Discrimination on the basis
of race, color, national origin includes
discrimination based on a person’s actual or
perceived race, color, national origin, ethnicity, or
ancestry.’’) (emphasis added).
335 490 U.S. 228, 250–51 (1989).
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explained, ‘‘we are beyond the day
when an employer could evaluate
employees by assuming or insisting that
they matched the stereotype associated
with their group,’’ for ‘‘[i]n forbidding
employers to discriminate against
individuals because of their sex,
Congress intended to strike at the entire
spectrum of disparate treatment of men
and women resulting from sex
stereotypes.’’ 336 The Supreme Court
reiterated this principle in Bostock,
explaining that ‘‘an employer who fires
both [a woman] and [a man] for failing
to fulfill traditional sex stereotypes
doubles rather than eliminates Title VII
liability.’’ 337
We are proposing to include ‘‘sex
characteristics’’ because discrimination
based on anatomical or physiological
sex characteristics (such as genitals,
gonads, chromosomes, hormone
function, and brain development/
anatomy) is inherently sex-based.
Discrimination on the basis of intersex
traits is similarly prohibited sex
discrimination because the individual is
being discriminated against based on
their sex characteristics. If their sex
characteristics were different—i.e.,
traditionally ‘‘male’’ or ‘‘female’’—the
intersex person would be treated
differently. Moreover, like gender
identity and sexual orientation, intersex
traits are ‘‘inextricably bound up with’’
sex,338 and ‘‘cannot be stated without
referencing sex.’’ 339 The DOJ has
similarly concluded that Bostock’s
reasoning applies to discrimination
based upon intersex traits.340
The proposed inclusion of
‘‘pregnancy or related conditions’’ is
consistent with the longstanding
interpretation of sex discrimination
under Title IX, including the
Department’s Title IX implementing
regulation.341
336 Id.; cf. U.S. v. Virginia, 518 U.S. 515, 533
(1996) (in making classifications based on sex,
states ‘‘must not rely on overboard generalizations
about the different talents, capacities, or preferences
of males and females’’).
337 Bostock v. Clayton Cty., 140 S. Ct. 1731, 1742–
43 (2020).
338 Id. at 1742.
339 Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d
586, 608 (4th Cir. 2020) (quoting Whitaker v.
Kenosha Unified Sch. Dist. No. 1 Bd. of Educ., 858
F.3d 1034, 1051 (7th Cir. 2017)).
340 See Memorandum from Kristen Clarke,
Assistant Att’y Gen., Civil Rights Div., U.S. Dep’t
of Justice, to Dep’t of Justice Office of Justice
Programs, Office of Cmty. Oriented Policing Servs.,
Office on Violence Against Women, & Money
Laundering & Asset Recovery Section, 2 (Mar. 10,
2022), https://www.justice.gov/crt/page/file/
1481776/download; U.S. Dep’t of Justice, Title IX
Legal Manual, Title IX Cover Addendum postBostock (updated Aug. 12, 2021), https://
www.justice.gov/crt/title-ix#Bostock.
341 See Conley v. Northwest Fla. State Coll., 145
F. Supp. 3d 1073 (N.D. Fla. 2015). See also 45 CFR
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The proposed inclusion of ‘‘sexual
orientation’’ and ‘‘gender identity’’ is
consistent with the Supreme Court’s
reasoning in Bostock. As explained in
the Department’s Bostock Notification,
the Court’s reasoning applies to Title IX
and, by extension, to Section 1557.342
Given the similarity in
nondiscrimination language between
Title VII and Title IX, most Federal
courts 343 that have addressed the issue,
and the Departments of Justice and
Education, have interpreted Title IX
consistent with Bostock’s reasoning.344
The Franciscan Alliance court
concluded that the 2016 Rule’s
definition of ‘‘sex’’ as including ‘‘gender
identity’’ was contrary to Section 1557
because ‘‘Title IX and Congress’
incorporation of it in [Section 1557 of]
the ACA unambiguously adopted the
binary definition of sex.’’ 345 The
Department disagrees. In Bostock, the
Supreme Court held that the prohibition
on discrimination ‘‘because of . . . sex’’
under Title VII covers discrimination on
the basis of gender identity and sexual
orientation even assuming that ‘‘sex’’
refers ‘‘only to biological distinctions
between male and female.’’ 346 Title IX
and Section 1557 prohibit
discrimination ‘‘on the basis of sex.’’ 347
Because their statutory prohibitions
against sex discrimination are similar,
the Supreme Court and other Federal
courts consistently look to
interpretations of Title VII to inform
Title IX.348 Thus, Bostock’s discussion
of the text of Title VII informs the
Department’s analysis of Title IX and
Section 1557.
First, like Title VII, Title IX and
Section 1557 apply to sex
discrimination against an individual.
Title VII states that it is unlawful for an
86.21(c)(2), (3); § 86.40(b)(1), (4), (5); § 86.51(b)(6);
§ 86.57(b)(d) (Title IX regulation).
342 86 FR 27984 (May 25, 2021).
343 Doe v. Snyder, No. 21–15668, 2022 WL
711420, at *9 (9th Cir. Mar. 10, 2022); Grimm v.
Gloucester Cty. Sch. Bd., 972 F.3d at 616; Koenke
v. Saint Joseph’s Univ., No. 19–cv–4731, 2021 WL
75778, at *2 (E.D. Pa. Jan. 8, 2021); Doe v. Univ.
of Scranton, No. 3:19–cv–01486, 2020 WL 5993766,
at *11 n.61 (M.D. Pa. Oct. 9, 2020); but see Neese
v. Becerra, No. 2:21–cv–00163–Z, 2022 WL
1265925, at *14 (N.D. Tex. Apr. 26, 2022) (denying
motion to dismiss, finding ‘‘at this stage of
litigation, the approved tools of textualism do not
support’’ application of Bostock to ‘‘Title IX—and
by extension Section 1557’’).
344 Karlan Memo, supra note 46; 86 FR 32637
(June 22, 2021) (Department of Education).
345 Franciscan All., Inc. v. Burwell, 227 F. Supp.
3d 660, 689 (N.D. Tex. 2016).
346 140 S. Ct. at 1744.
347 20 U.S.C. 1681(a); 42 U.S.C. 18116.
348 See, e.g., Franklin v. Gwinnett Cty. Pub. Sch.,
503 U.S. 60, 75 (1992); Jennings v. Univ. of N.C.,
482 F.3d 686, 695 (4th Cir. 2007); Gossett v.
Oklahoma ex rel. Bd. of Regents for Langston Univ.,
245 F.3d 1172, 1176 (10th Cir. 2001).
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employer ‘‘to fail or refuse to hire or to
discharge any individual, or otherwise
to discriminate against any individual’’
regarding their ‘‘compensation, terms,
conditions, or privileges of employment,
because of such individual’s race, color,
religion, sex, or national origin.’’ 349 The
Bostock Court focused on this feature of
Title VII in reaching its holding.350
Similarly, Title IX states that ‘‘no person
in the United States shall, on the basis
of sex, be excluded from participation
in, be denied the benefits of, or be
subjected to discrimination under any
education program or activity receiving
Federal financial assistance.’’ 351
Furthermore, Section 1557 provides that
‘‘an individual shall not, on the ground
prohibited [under Title VI, Title IX, the
Age Act, or Section 504] be excluded
from participation in, be denied the
benefits of, or be subjected to
discrimination under, any health
program or activity, any part of which
is receiving Federal financial
assistance.’’ 352
Second, Title IX’s ‘‘on the basis of’’
sex language is sufficiently similar to
‘‘because of’’ sex under Title VII as to
be considered interchangeable. In
Bostock itself, the Supreme Court
described Title VII’s language that way:
‘‘[I]n Title VII, Congress outlawed
discrimination in the workplace on the
basis of race, color, religion, sex, or
national origin.’’ 353 The Bostock Court
concluded that Title VII’s prohibition of
discrimination ‘‘because of’’ sex
includes discrimination because of
sexual orientation and transgender
status, finding that when an employer
discriminates against employees for
being gay or transgender, ‘‘the employer
must intentionally discriminate against
individual men and women in part
because of sex.’’ 354 Indeed, the Court
clearly held that it is ‘‘impossible to
discriminate against a person’’ for being
gay or transgender ‘‘without
discriminating against that individual
on the basis of sex.’’ 355
The same reasoning in Bostock
supports the interpretation that Title
IX’s prohibition of discrimination ‘‘on
the basis of’’ sex, and, relatedly, that
349 42
U.S.C. 2000e–2(a)(1) (emphasis added).
140 S. Ct. at 1740–41 (‘‘[The statute]
tells us three times—including immediately after
the words ‘‘discriminate against’’—that our focus
should be on individuals.’’).
351 20 U.S.C. 1681(a) (emphasis added).
352 42 U.S.C. 18116 (emphasis added).
353 Bostock, 140 S. Ct. at 1737; see also Meritor
Sav. Bank, FSB v. Vinson, 477 U.S. 57, 64 (1986)
(‘‘[W]hen a supervisor sexually harasses a
subordinate because of the subordinate’s sex, that
supervisor ‘discriminate[s]’ on the basis of sex.’’)
(emphasis added).
354 Bostock, 140 S. Ct. at 1740–43.
355 Id. at 1741.
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350 Bostock,
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Section 1557’s prohibition on
discrimination ‘‘on the ground
prohibited under Title IX’’ prohibits
covered entities from discriminating
against an individual based on that
person’s sexual orientation or
transgender status. After considering the
text of Title IX and Section 1557,
Supreme Court case law, and
developing jurisprudence in this area,
the Department has determined that the
best reading of Title IX’s prohibition on
discrimination ‘‘on the basis of sex’’ and
Section 1557’s prohibition on
discrimination ‘‘on the ground
prohibited under Title IX’’ is that it
includes discrimination on the basis of
gender identity and sexual orientation.
Should there be any ambiguity read into
the statutory text of Title IX or Section
1557 with regard to this issue, the
Department would nonetheless adopt
this interpretation given the statutory
objectives of the civil rights statutes and
the importance of ensuring that
individuals are able to receive health
care free from discrimination.
Proposed paragraph (b) identifies
several specific forms of prohibited
discrimination under Section 1557. It
does so by incorporating by reference
the specific prohibitions on
discrimination in the regulations
implementing each civil rights statute
referenced in Section 1557’s statutory
text. Even though Section 1557 provides
an independent basis for the regulation
of discrimination in covered programs
and activities, this proposed section
expressly adopts the specific
prohibitions on discrimination found in
the implementing regulations of the
referenced antidiscrimination statutes.
We believe this approach is appropriate
in light of Section 1557’s express
adoption of the same language used in
the four referenced statutes to describe
the nature of the prohibited conduct—
namely, causing an individual to ‘‘be
excluded from participation in, be
denied the benefits of, or be subjected
to discrimination under’’ a specified
program or activity. Incorporating by
reference the regulations that have long
described certain forms of such conduct
under those specified statutes is
consistent with the ACA and provides
clarity, while not including redundant
text in this rule. The text proposes to
direct the reader to the ‘‘prohibitions on
discrimination’’ in sections of the Title
VI, Section 504, Title IX (subparts C and
D), and Age Act (subpart B) regulations.
This is similar to the approach taken in
the 2016 Rule but, rather than citing
specific provisions, we propose a
general reference.
Though the 2020 Rule purported to
clarify covered entities’ Section 1557
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obligations, it sought to do so through
general statements. The 2020 Rule, at
§ 92.2, generally provides the
nondiscrimination requirements of
Section 1557 by restating the statutory
language of 42 U.S.C. 18116(a), followed
by stating that the grounds prohibited
are the grounds found in the Title VI,
Title IX, Section 504, and Age Act
statutes. This approach has caused
confusion by eliminating guidance as to
certain specific discriminatory actions
that one generally finds in an
implementing regulation for a civil
rights statute. The Department believes
it is helpful for covered entities and
protected individuals to have additional
clarity regarding some common, specific
prohibitions under Section 1557.
We believe the proposed approach is
the most reasonable reading of Section
1557’s direction that ‘‘an individual
shall not . . . be excluded from
participation in, be denied the benefits
of, or be subjected to discrimination
under, any health program or activity,
any part of which is receiving Federal
financial assistance, including credits,
subsidies, or contracts of insurance, or
under any program or activity that is
administered by an Executive Agency or
any entity established under this title
(or amendments).’’ 356 Because this
language is adapted from the four
referenced statutes, it is reasonable and
appropriate to look to those statutes’
implementing regulations to further
clarify what it means to discriminate on
the grounds prohibited by those
statutes. Rather than restating each of
the specific prohibitions on
discrimination under each
implementing regulation, we propose
that § 92.101(b) simply cross-reference
the implementing regulations of these
referenced civil rights statutes. Note that
this proposed rule does not in any way
limit or impact the interpretation of
those statutes.
Proposed paragraph (b)(1)(i)
specifically refers to recipients of
Federal financial assistance and State
Exchanges; proposed paragraph (b)(1)(ii)
refers to the Department’s health
programs and activities, including
Federally-facilitated Exchanges. Under
both of these paragraphs, covered
entities would be prohibited from the
discriminatory actions found in the
applicable sections of the Title VI, Title
IX, and Age Act implementing
regulations, found at 45 CFR parts 80,
86 (subparts C and D), and 91 (subpart
B), respectively. For the specific
discriminatory actions provided for in
Section 504 implementing regulation,
recipients and State Exchanges will look
356 42
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to the implementing regulation at 45
CFR part 84 (federally funded), and the
Department will look to the
implementing regulation at 45 CFR part
85 (federally conducted).
Proposed paragraph (b)(2) provides
that the enumeration of specific forms of
discrimination in paragraph (b) of this
section does not limit the general
application of the prohibition in
proposed paragraph (a) of this section.
Although some of these provisions
would articulate specific forms of
prohibited discrimination that have not
otherwise been articulated under some
of the underlying statutes referenced in
Section 1557, these provisions are
included to ensure parity across all
prohibited bases of discrimination
under Section 1557 with regard to
covered entities’ health programs and
activities.
The 2016 Rule included, at former
§ 92.101(b)(3)(ii) and (iii), provisions
specifically related to prohibited
discrimination on the basis of sex
related to criteria and methods of
administration and selection of facility
sites and locations that have the effect
of discriminating on the basis of sex or
the purpose or effect of defeating or
substantially impairing the
accomplishment of the objectives of the
program or activity on the basis of sex.
The 2020 Rule removed these
paragraphs. The 2016 Rule language is
similar to language found in the
implementing regulations for Title VI,
Section 504, and the Age Act.357 The
Department has determined not to
include a similar provision here as the
Department believes it is important to
preserve—and not expand—the
longstanding treatment of disparate
impact in the referenced statutes’
implementing regulations. We seek
comment on this approach, including
whether a provision similar to that
included in the 2016 Rule is necessary,
and whether it should be limited to
discrimination on the basis of sex, or
should also include each of the
enumerated grounds covered under
Section 1557’s statutory prohibition on
discrimination.
Subpart C—Specific Applications to
Health Programs and Activities
Because of Section 1557’s unique
application to health programs and
activities, Subpart C provides additional
specificity regarding nondiscrimination
requirements in this setting. The
provisions in this subpart are responsive
to the nature and importance of health
care, health insurance, and related
357 45 CFR 80.3(b)(2), (3) (Title VI); § 84.4(b)(4),
(5) (Section 504); § 90.12.(b) (Age Act).
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decision-making as it impacts
individuals and communities protected
by Section 1557’s prohibition of
discrimination. These provisions are
intended to provide clear instruction to
covered entities and are informed by
OCR’s stakeholder outreach and
experience in both enforcement and in
providing technical assistance.
Meaningful Access for Limited English
Proficient Individuals (§ 92.201)
Proposed § 92.201 effectuates Section
1557’s prohibition on national origin
discrimination as it is applied to LEP
individuals in covered health programs
and activities. For LEP individuals, the
lack of proficiency in English and the
use of non-English languages is often
tied to their national origin. It is wellestablished that an entity may violate
Title VI and its implementing regulation
by failing to take reasonable steps to
provide meaningful access to LEP
individuals.358 The provision of free
and effective language assistance
services to LEP individuals is essential
to ensure compliance with
nondiscrimination laws.
Proposed paragraph (a) provides that
covered entities ‘‘must take reasonable
steps to provide meaningful access to
each limited English proficient
individual eligible to be served or likely
to be directly affected by its health
programs and activities.’’ This language
is nearly identical to the 2016 Rule at
former § 92.201(a), which required a
covered entity to take reasonable steps
to provide meaningful access to each
LEP individual ‘‘eligible to be served or
likely to be encountered.’’ 359 The
Department is proposing to revise this
language slightly to include individuals
likely to be ‘‘directly affected’’ rather
358 See, e.g., Lau v. Nichols, 414 U.S. 563, 566
(1974) (interpreting Title VI and its implementing
regulations to require a school district with students
of Chinese origin with limited English proficiency
to take affirmative steps to provide the students
with a meaningful opportunity to participate in
federally funded educational programs); Dep’t of
Health, Educ., & Welfare, Identification of
Discrimination and Denial of Services on the Basis
of National Origin, 35 FR 11595 (July 18, 1970);
E.O. 13166, Improving Access to Services. for
Persons with Limited English Proficiency, 65 FR
50121 (Aug. 16, 2000) (directing Federal agencies
that extend assistance subject to the requirements
of Title VI to publish guidance for their respective
recipients clarifying the obligation to provide
language services to LEP individuals); Dep’t of
Justice, Guidance to Federal Financial Assistance
Recipients Regarding Title VI Prohibition Against
National Origin Discrimination Affecting Limited
English Proficient Persons, 67 FR 41455, 41457
(June 18, 2002); Dep’t of Educ., Office for Civil
Rights & Dep’t of Justice, Civil Rights Div., Dear
Colleague Letter: English Learner Students and
Limited English Proficient Parents (Jan. 7, 2015),
https://www2.ed.gov/about/offices/list/ocr/letters/
colleague-el-201501.pdf.
359 Former 45 CFR 92.201(a).
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than ‘‘encountered.’’ This language is
consistent with the 2003 HHS LEP
Guidance 360 and OCR resolution
agreements,361 and we believe this
language provides more clarity for
covered entities regarding the
individuals for whom reasonable steps
must be taken. As the Department has
advised in the past, ordinarily, persons
eligible to be served or likely to be
directly affected by a recipient’s
program are those persons who are in
the covered entity’s service area, and
who either are eligible for the covered
entity’s benefits or services, or
otherwise might be directly affected by
such an entity’s conduct. For example,
a parent seeking health services for a
child would be seen as directly affected
by a covered entity’s policies and
practices.362
The language of the 2020 Rule differs
from the 2016 Rule in that it requires
reasonable steps to ensure meaningful
access ‘‘to programs or activities by
limited English proficient individuals,’’
rather than ‘‘each’’ LEP individual.363
The preamble to the 2020 Rule explains
this change by arguing that the 2016
Rule’s ‘‘stringent requirement . . .
could potentially be interpreted to
require a covered entity to provide
language assistance services to every
LEP individual it comes into contact
with.’’ 364 The plain language of the
2016 Rule in fact required that covered
entities must take reasonable steps to
provide meaningful access to each
individual with limited English
proficiency eligible to be served or
likely to be encountered in its health
programs and activities.365 For example,
a surgeon would likely determine that it
is a reasonable step to provide an
interpreter when discussing the risks
and aftercare of a particular procedure
with an LEP individual in order to
afford that individual meaningful
access; however, a hospital may
determine that reasonable access can be
provided via sight translation of a
generic brochure for an LEP patient
rather than providing a fully translated
version. This standard does not impose
a significant burden on covered entities,
as it does not mandate that every LEP
individual receive language services,
360 68
FR 47311, 47314 (Aug. 8, 2003).
e.g., Voluntary Resolution Agreement
between U.S. Dep’t Health & Human Servs., Office
for Civil Rights & Pa. Dep’t of Human Servs. (2019),
https://www.hhs.gov/sites/default/files/hhs-padhsvra.pdf.
362 See, e.g., 65 FR 52762, 51767–68 (Aug. 30,
2000).
363 85 FR 37160, 37245 (June 19, 2020); 45 CFR
92.101(a).
364 85 FR 37210.
365 81 FR 31375, 31470 (May 18, 2016).
361 See,
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but rather that covered entities at a
minimum conduct a reasonable steps
evaluation for each LEP individual.
However, the Department notes that, as
the availability of telephonic
interpreters increases, the evaluation of
the reasonableness of providing
language services shifts.
Taking reasonable steps to assess and
meet the needs of each LEP individual
eligible to be served or likely to be
directly affected by the covered entity’s
health program or activity is important
to ensure compliance with both Title VI
and Section 1557. The need for a caseby-case determination is particularly
important in the area of health care. As
noted in the preamble to the 2016 Rule,
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[S]afe and quality health care requires an
exchange of information between the health
care provider and patient for the purposes of
diagnoses, treatment options, the proper use
of medications, obtaining informed consent,
and insurance coverage of health-related
services, among other purposes. This
exchange of information is jeopardized when
the provider and the patient speak different
languages and may result in adverse health
consequences and even death. Indeed, the
provision of health care services, by its ‘very
nature[,] requires the establishment of a close
relationship with the client or patient that is
based on sympathy, confidence and mutual
trust,’ which cannot be established without
effective communication.366
Ensuring accurate, timely, and highquality communication within the
health care context is particularly
important to LEP individuals and their
families, who can be put in danger by
not understanding a physician or other
health care provider and the health
protocols those individuals may
prescribe. For example, an LEP parent
or guardian may leave a doctor’s office
misunderstanding how to properly care
for their child, putting the well-being of
the child at risk due to
miscommunication between the parent
or guardian and the doctor regarding the
health details of the child. Vigorous
communication standards are extremely
important in helping to minimize the
health care risks LEP people face in the
health care system, including lower
rates of outpatient follow up, poor
medication adherence, and a lack of
understanding of diagnosis and
discharge instructions.367 Nothing has
changed in this regard since the
publication of the 2016 Rule; rather, the
COVID–19 pandemic has demonstrated
how critical meaningful access to health
366 Id.
at 31413.
Dep’t Health & Human Servs., Ctrs. for
Medicare & Medicaid Servs., Guide to Preventing
Readmissions Among Racially and Ethnically
Diverse Medicare Beneficiaries, p. 4 (Sept. 2015),
https://essentialhospitals.org/wp-content/uploads/
2016/01/OMH_Readmissions_Guide.pdf.
367 U.S.
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programs and activities is for the health
and well-being of LEP individuals. A
recent study documented the unique
challenges faced by LEP individuals
during the COVID–19 pandemic. The
authors explained that factors like
under-interpretation of complex
conversations, non-universal use of
interpreters, fewer conversations
throughout the day with staff, not
receiving important medical paperwork
in their native language, and being
separated from social support networks
that often assist with the navigation of
health care systems exacerbated these
challenges for LEP individuals under
the social isolation of inpatient care
settings during the strict COVID–19 no
visitation policies.368
Proposed paragraph (b) states that
language assistance services required
under paragraph (a) must be provided
free of charge, be accurate and timely,
and protect the privacy and
independent decision-making ability of
an LEP individual. This provision is
similar to those included in the 2016
Rule at former § 92.201(c) and the 2020
Rule at § 92.101(b)(2) and is consistent
with longstanding Title VI requirements
and the HHS LEP Guidance.369 The
Department reminds states that they
have the option to claim Medicaid
reimbursement for the cost of
interpretation services, either as
medical-assistance or administration
related expenditures.370
Proposed paragraph (c) provides
specific requirements for interpreter and
translation services. Proposed paragraph
(c)(1) states that when interpreter
services are required under this part, a
covered entity must offer a qualified
interpreter. Proposed paragraph (c)(2)
provides that when translation services
are required under this part, a covered
entity must use a qualified translator.
These terms are defined in the
definitions section at proposed § 92.4.
Proposed paragraph (c)(3) addresses
the use of machine translation by
covered entities. Machine translation,
which can involve speech-based
machine translation to facilitate patientprovider communication as well as textbased machine translation to develop
multilingual health materials, is
368 Natale K. Kucirek et al., Stories from COVID–
19 Reveal Hospitalized Patients with Limited
English Proficiency Have Always Been Uniquely
Prone to Social Isolation, 36 J. of General Internal
Med. 786, 789 (2021), https://doi.org/10.1007/
s11606-020-06383-z.
369 68 FR 47316.
370 See Translation and Interpretation Services,
Ctrs. for Medicare & Medicaid Servs., https://
www.medicaid.gov/medicaid/financialmanagement/medicaid-administrative-claiming/
translation-and-interpretation-services/
(last visited June 15, 2022).
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increasingly being used as a method to
assist communication in the health care
setting and increase access to inlanguage health resources.371 While the
technology behind machine translation
has improved in accuracy, the
possibilities of significant consequences
from inaccurate translation continue to
exist.372 During the COVID–19
pandemic, several states and some
territories received complaints from LEP
individuals because they were unable to
sign up for COVID–19 vaccines on
websites using machine translation or
found translated information confusing
because of inaccuracies in some
translations.373 The prevalence of
inaccuracies was highlighted in a recent
literature review of articles discussing
machine translation in the health care
context, which found that no matter the
language or form of machine translation,
all studies indicated error rates so high
as to be ‘‘unacceptable for actual
deployment in health settings.’’ 374
The Department proposes regulatory
language requiring a covered entity that
uses machine translation to have
translated materials reviewed by a
qualified human translator when the
underlying text is critical to the rights,
benefits, or meaningful access of an LEP
371 Kristin N. Dew et al., Development of Machine
Translation Technology for Assisting Health
Communication: A Systematic Review, 85 J. of
Biomedical Informatics 56, 57 (2018), https://
reader.elsevier.com/reader/sd/pii/
S1532046418301448?token=
D92E78CBB86826ADC4834
79DED4B8E8442AE7763
0BCCB53F5385AE5AD2452E
7FFC803B8CBA43AC533
A509E3F977291BC&originRegion=us-east1&originCreation=20220615184038.
372 See Wenxiu Xie et al., Predicting Risks of
Machine Translations of Public Health Resources by
Developing Interpretable Machine Learning
Classifiers, 18 Int. J. Environ. Res. Pub. Health 8789
(2021), https://www.mdpi.com/1660-4601/18/16/
8789/htm; Lucas N. Vieira et al., Understanding the
Societal Impacts of Machine Translation: A Critical
Review of the Literature on Medical and Legal Use
Cases, 24 Info., Comm., & Soc’y 1515 (2020),
https://www.tandfonline.com/doi/full/10.1080/
1369118X.2020.1776370; Nicole Wetsman, Google
Translate Still Isn’t Good Enough for Medical
Instructions, The Verge (Mar. 9, 2021), https://
www.theverge.com/2021/3/9/22319225/googletranslate-medical-instructions-unreliable; Breena R.
Taira et al., A Pragmatic Assessment of Google
Translate for Emergency Department Instructions,
36 J. Gen. Intern. Med. 3361 (2021), https://
link.springer.com/article/10.1007%2Fs11606-02106666-z; Mark P. Sendak et al., A Path for
Translation of Machine Learning Products into
Healthcare Delivery, EMJ Innov., Jan. 27, 2021,
https://emj.emg-health.com/wp-content/uploads/
sites/2/2020/01/A-Path-for-Translation-of-MachineLearning.....pdf; Dew, supra note 371.
373 Julie Zauzmer Weil, DC Says Long-Awaited
Translation of Vaccine Website Is Coming This
Weekend, Wash. Post (Apr. 9, 2021), https://
www.washingtonpost.com/local/coronavirusvaccine-translation-spanish/2021/04/09/40ed126a9942-11eb-962b-78c1d8228819_story.html.
374 Dew, supra note 371, at 64.
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individual; when accuracy is essential;
or when the source documents or
materials contain complex, non-literal,
or technical language.
We seek comment on the use of
machine translation in health programs
and activities generally, other possible
approaches to address this issue, and
whether there should be an exception to
this provision to allow for the limited
use of machine translation in exigent
circumstances.
Proposed paragraph (d) addresses
how the Director will evaluate
compliance with this section. The 2015
NPRM in then-proposed § 92.201(b)(1)
provided that the Director would
evaluate a covered entity’s compliance
with meaningful access for LEP
individuals by giving substantial weight
to the nature and importance of the
program or activity and the particular
communication at issue.375 The 2015
NPRM also identified five other relevant
factors that the Director would
consider.376 In response to comments,
the preamble to the 2016 Rule
eliminated the list of five factors and
articulated only one factor in former
§ 92.201(b)(2): whether a covered entity
had developed and implemented an
effective written language access plan
appropriate to its circumstances.377
Commenters suggested many other
factors that could be included.378 The
preamble explained that including
multiple illustrative factors in the
regulatory text may create the erroneous
impression that the Director will not
consider other relevant factors, and
trying to capture all possible factors
could result in an unintentionally
unworkable regulatory scheme.379
Accordingly, the preamble to the 2016
Rule contains a lengthy list of factors
that may be relevant in a particular case,
including:
the length, complexity, and context of the
communication; the prevalence of the
language in which the individual
communicates among those eligible to be
served or likely to be encountered by the
health program or activity; the frequency
with which a covered entity encounters the
language in which the individual
communicates; whether a covered entity has
explored the individual’s preference, if any,
for a type of language assistance service, as
not all types of language assistance services
may work as well as others in providing an
individual meaningful access to the covered
entity’s health program or activity; the cost
of language assistance services and whether
a covered entity has availed itself of cost375 80
FR 54171, 54218 (Sept. 8, 2015).
376 Id.
377 81
FR 31470.
378 Id. at 31415.
379 Id.
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saving opportunities; and all resources
available to the covered entity, including the
entity’s capacity to leverage resources among
its partners or to use its negotiating power to
lower the costs at which language assistance
services could be obtained.380
At paragraph (d)(1), we propose that
the Director shall evaluate, and give
substantial weight to, the nature and
importance of the health program or
activity and the particular
communication at issue, to the LEP
individual. This is the same language as
was included in the 2016 Rule.381
Proposed paragraph (d)(2) provides that
the Director shall take into account
other relevant factors, including the
effectiveness of the covered entity’s
written language access procedures for
its health programs and activities, that
the covered entity has implemented
pursuant to proposed § 92.8(d) of this
part. In this proposed regulation, we are
not requiring a formal language access
plan; however, we continue to strongly
encourage covered entities to develop
such plans, in concert with developing
and implementing language access
procedures required under proposed
§ 92.8(d), to be in a better position to
meet their obligations to provide
effective language services in a timely
manner.
The proposed language contrasts with
the 2020 Rule which, at § 92.101(b)(1),
provides that the Director will assess
how the covered entity balances four
factors,382 essentially adopting the
‘‘four-factor analysis’’ found in the HHS
LEP Guidance.383 The preamble to the
2020 Rule notes that ‘‘some commenters
believed that the four-factor analysis
under § 92.101(b) is too broad, lacks
clarity, does not ensure that translation
and other language services are
available under important medical
circumstances, may require recipients to
provide unnecessarily expensive
services, and weakens recipient
language access obligations to serve
persons who speak infrequently
encountered languages.’’ 384 The 2020
Rule preamble states that OCR viewed
the four-factor analysis as an
380 Id.
at 31416.
45 CFR 92.201(b)(1).
382 See 85 FR 37245.
383 68 FR 47311, 47314 (Aug. 8, 2003) (suggesting,
as a starting point for covered entities meeting their
obligations, the balancing of four factors: (1) the
number or proportion of LEP persons eligible to be
served or likely to be encountered by the program
or grantee; (2) the frequency with which LEP
individuals come in contact with the program; (3)
the nature and importance of the program, activity,
or service provided by the program to people’s
lives; and (4) the resources available to the grantee/
recipient and costs).
384 85 FR 37212.
381 Former
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appropriate way ‘‘to allow flexibility for
covered entities.’’ 385
During the four years that these
provisions of the 2016 Rule were in
effect, former § 92.201(a) was never
challenged. However, the standard
contained in the 2020 Rule has been
challenged in Federal district court. In
Chinatown Service Center, plaintiffs
alleged that the 2020 Rule’s replacement
of the standard in former § 92.201(a)
resulted in only a ‘‘generalized duty’’ to
LEP individuals rather than a case-bycase review to ensure the covered
entities take reasonable steps to provide
each individual with limited English
proficiency with necessary language
assistance services.386
After reviewing and reconsidering
comments received in response to the
2019 NPRM, we believe that the fourfactor analysis is more appropriately
described as a general framework for
planning on a system-wide and sitelevel basis, but does not provide clarity
as to what the covered entity’s
obligations are to a particular
individual. The proposed rule applies
the general obligation to take reasonable
steps to provide meaningful access and
focuses on the steps the covered entity
must take for each individual in the
health care setting.
The level of specificity we propose is
especially important when addressing
benefits or services with high
importance or consequences such as
those provided in the health care
setting. This specificity helps guide a
covered entity by supplying a
framework that they can choose to use,
while providing a covered entity an
appropriate level of flexibility to
determine how best to comply with
statutory and regulatory obligations to
provide meaningful access to LEP
individuals. Therefore, while we have
taken the four-factor analysis into
consideration in formulating the
specific provisions, we decline to
include it in this proposed regulation.
We seek comment on this approach.
Proposed paragraph (e) identifies
restrictions on the use of certain persons
to provide language assistance services
for LEP individuals. This language is
similar to that contained in the 2020
Rule at § 92.101(b)(4), with additional
descriptors to ensure the best available
and most accurate language assistance
services in covered health programs and
activities.387 Proposed paragraph (e)(1)
prohibits covered entities from requiring
LEP individuals to provide, or pay for,
385 Id.
386 See
Chinatown Serv. Ctr. Compl., supra note
309.
387 85
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their own interpreters. Proposed
paragraph (e)(2) provides for very
limited situations in which an adult, not
qualified as an interpreter,
accompanying an LEP individual can
serve as an interpreter. The first limited
circumstance includes an emergency
involving an imminent threat to the
safety or welfare of an individual or the
public where there is no qualified
interpreter for the LEP individual
immediately available. For example,
directly following a natural disaster
such as an earthquake, a covered entity
may temporarily rely on a non-qualified
interpreter to help first responders
provide services to LEP individuals
during emergency response and
recovery efforts. This is permitted only
as a temporary measure while finding a
qualified interpreter, and the qualified
interpreter that arrives must confirm or
supplement the initial communications
with the accompanying adult.
In the second limited circumstance,
an adult who is not qualified as an
interpreter may also serve as an
interpreter when: an LEP individual
specifically requests that the
accompanying adult interpret or
facilitate communication; the
accompanying adult agrees to provide
such assistance; the request and
agreement by the accompanying adult is
documented; and reliance on that adult
for such assistance is appropriate under
the circumstances. When considering
whether the reliance on such an adult
to interpret without confirming or
supplementing the interpretation is
appropriate, the covered entity should
consider the accompanying adult’s
language proficiency in both English
and the primary language of the LEP
individual; the possibility of bias;
whether the individual is an interested
party, such as in situations of domestic
violence; and whether the
accompanying adult helps the covered
entity better understand the LEP
individual. Covered entities should also
keep in mind that untrained
‘‘interpreters’’ are more likely to make
errors, violate confidentiality, and
increase the risk of poor outcomes.388 If
the covered entity is unable to make the
required assessment, relying on the
accompanying adult is inappropriate.
Proposed paragraph (e)(3) prohibits a
covered entity from relying on a minor
child to interpret or facilitate
communication, except as a temporary
measure while finding a qualified
interpreter in an emergency involving
388 Gregory Juckett & Kendra Unger, Appropriate
Use of Medical Interpreters, 90 A. Fam. Physician
476 (2014), https://www.aafp.org/pubs/afp/issues/
2014/1001/p476.html.
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an imminent threat to the safety or
welfare of an individual or the public
where there is no qualified interpreter
for the LEP individual immediately
available—for example, directly
following a serious car accident where,
due to the nature of the injuries
sustained, an LEP individual’s critical
care is a priority. Once the qualified
interpreter has arrived, they must
confirm or supplement the initial
communications with the minor child.
The use of children as interpreters raises
the same concerns as those of an
accompanying adult who is not
qualified as an interpreter, but also
poses other problems including
exposing children to complex health
care interactions for which they are not
developmentally prepared, upsetting a
family power dynamic, causing
embarrassment, and conveying incorrect
or incomplete information.389
Proposed paragraph (e)(4) prohibits
reliance on staff other than qualified
interpreters, qualified translators, or
qualified bilingual or multilingual staff
to communicate directly with LEP
individuals.
Proposed paragraph (f) addresses
standards for video remote interpreting
(VRI) and is identical to former
§ 92.201(f) in the 2016 Rule.390 The
preamble to that rule states the purpose
of developing VRI standards was to
address concerns that the use of this
technology may result in less
comprehensible communication. The
2016 Rule preamble also explains that
the VRI standards are designed to
achieve parity with the regulation in the
disability rights context.391 These
standards closely parallel those
standards set forth in proposed § 92.202
regarding effective communication for
individuals with disabilities, which,
similar to the 2016 Rule, relies on
standards in Title II of the ADA for the
use of sign language interpreters.
The 2020 Rule does not address VRI
services. The preamble explains that in
place of VRI standards, the final rule
adopts the four-factor analysis ‘‘which
will help covered entities balance
competing considerations related to VRI
quality standards.’’ 392 The 2020 Rule
RIA states that ‘‘the burden of requiring
covered entities to provide video
technology training and utilize
expensive software does not appear to
be justified based on minimal benefit to
389 See,
e.g., Sunmin Lee et al., Barriers to Health
Care Access in 13 Asian American Communities, 45
Am. J. Health Behav. 21, 22 (2010), https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC6628721/;
Wooksoo, supra note 106, at 289.
390 81 FR 31375, 31470–71 (May 18, 2016).
391 Id. at 31418.
392 85 FR 37213.
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language speakers who can effectively
communicate when there is a clear
audio transmission through the remote
interpreting service.’’ 393 The
Department disagrees with this
assessment. Performance standards are
necessary so that VRI technologies do
not result in ineffective communication.
The plain terms of this provision do not
require a covered entity to provide VRI
but rather ensure that when such
services are used, they must meet a
quality standard.
Proposed paragraph (g) sets forth
standards for audio remote interpreting
services. Those standards, which are
likewise important in order to have
meaningful communication, are
identical to those in the 2020 Rule at
§ 92.101(b)(3)(iii).394
Proposed paragraph (h) states that
nothing in this section shall be
construed to require an LEP individual
to accept language assistance services.
Identical language is contained in the
2020 Rule at § 92.101(c), and the 2016
Rule at former § 92.101(g).395
Effective Communication for
Individuals With Disabilities (§ 92.202)
Proposed § 92.202 addresses
requirements related to providing
effective communication for individuals
with disabilities. The 2020 Rule at
§ 92.102 and the 2016 Rule at former
§ 92.202 contain substantially the same
requirements as this proposed section.
In proposed paragraph (a), we require
a covered entity to take appropriate
steps to ensure that communications
with individuals with disabilities, and
companions with disabilities, are as
effective as communications with
individuals without disabilities in its
health programs and activities,
incorporating the standards found at 28
CFR 35.130 and 35.160 through 35.164
of the regulation implementing Title II
of the ADA. Proposed paragraph (a) is
similar to the 2020 Rule at § 92.102(a),
with the addition of ‘‘companions’’ to
codify the Department’s longstanding
position that a covered entity’s
obligation to ensure effective
communication extends not just to
individuals with disabilities but to
companions as well, if they are
individuals with disabilities.396
393 Id.
394 Id.
at 37223.
at 37246.
395 Id.
396 Consistent with the Department’s position in
the 2016 Rule; 42 U.S.C. 12182(b)(1)(E)(Title III); 28
CFR 35.130(g) (Title II). See generally, U.S. Equal
Emp’t Opportunity Comm’n, Questions & Answers:
Association Provision of the ADA (Oct. 17, 2005),
https://www.eeoc.gov/laws/guidance/questionsanswers-association-provision-ada; cf. Loeffler v.
Staten Island Univ. Hosp., 582 F.3d 268, 277 (2d
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Because we propose to incorporate all
of the relevant Title II standards into
proposed paragraph (a), including
requirements that were enumerated in
the 2020 Rule (e.g., the requirements to
provide auxiliary aids and services in a
timely manner and free of charge, and
to give primary consideration to the
requests of individuals with disabilities
when determining what types of
auxiliary aids and services are
necessary), we do not propose to
enumerate these specific additional
standards in this rule. This proposed
section also clarifies that where the
regulatory provisions referenced in this
section use the term ‘‘public entity,’’ the
term ‘‘covered entity’’ shall apply in its
place.
We propose in paragraph (b) to
explicitly require covered entities to
provide appropriate auxiliary aids and
services to individuals with impaired
sensory, manual, or speaking skills,
where necessary to afford such
individuals an equal opportunity to
benefit from the service in question.
Once again, this paragraph is
substantially similar to the 2020 Rule at
§ 92.102(b), which applied to recipients
and State Exchanges. Because all
covered entities, including the
Department, are required to provide
auxiliary aids and services, we propose
to apply paragraph (b) to all covered
entities, not just recipients and State
Exchanges.397
We also note that in order to ensure
a covered entity meets its obligations to
provide both meaningful access and
effective communication for LEP
individuals with disabilities, it must
comply with both proposed § 92.201
and proposed § 92.202. Auxiliary aids
and services that are not provided in a
language consistent with proposed
§ 92.201 do not satisfy the requirements
of proposed § 92.202. For example, a
covered entity that only offered
auxiliary aids and services in English to
an LEP individual with a disability may
be in violation of both proposed
§ 92.201 and § 92.202.
The 2020 Rule defines ‘‘disability,’’
‘‘auxiliary aids and services’’ and
‘‘qualified interpreter’’ at § 92.201; those
definitions are now located in proposed
§ 92.4.
Cir. 2009) (permitting associational discrimination
claim under Section 504); Falls v. Prince George’s
Hosp. Ctr., No. Civ. A 97–1545, 1999 WL 33485550,
at *11 (D. Md. Mar. 16, 1999) (holding that parent
had an associational discrimination claim under
Section 504 when hospital required hearing parent
to act as interpreter for child who was deaf).
397 The Department is required to provide
appropriate auxiliary aids and services under 45
CFR 85.51(a)(1) of this subchapter, which is
incorporated by reference under proposed
§ 92.101(b)(1)(ii).
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Accessibility for Buildings and
Facilities (§ 92.203)
Proposed § 92.203 adds a general
provision establishing that no qualified
individual with a disability shall,
because a covered entity’s facilities are
inaccessible to or unusable by
individuals with disabilities, be denied
the benefits of, be excluded from
participation in, or otherwise be
subjected to discrimination under any
health program or activity to which this
part applies, consistent with the
Department’s Section 504 regulation
covering federally assisted and federally
conducted programs and activities.398
The remainder of proposed § 92.203
incorporates the identical language
found in the 2020 Rule at § 92.103,
except that the definitions for ‘‘1991
Standards,’’ ‘‘2010 Standards,’’ and
‘‘UFAS’’ are now located in proposed
§ 92.4.
Accessibility of Information and
Communication Technology for
Individuals With Disabilities (§ 92.204)
Proposed § 92.204 addresses the
accessibility of information and
communication technology (ICT) for
individuals with disabilities. This
proposed section is substantially the
same as § 92.104(a)–(b) of the 2020 Rule
and former § 92.204 of the 2016 Rule.
The 2020 Rule also defines ‘‘information
and communication technology’’ at
§ 92.104(c), which we propose to define
at proposed § 92.4.
With the advent of COVID–19
constraints placed on in-person
services, the use of technology has
become ever more critical. Covered
entities have adapted creatively
utilizing remote communications
technologies to provide telehealth
services, including audio, text
messaging or video conferencing.
Additionally, websites and online
portals are serving as primary
registration vehicles for obtaining
COVID–19 tests and vaccines. In some
instances, however, the use of
inaccessible websites or online portals
has resulted in access barriers for
individuals with disabilities. For
example, individuals with vision
impairments who use screen reader
software or persons with mobility
impairments who have difficulty using
a mouse, may not be able to access
inaccessible online registration forms or
navigate inaccessible vaccine
websites.399
398 45 CFR 84.21 (federally assisted); § 85.41
(federally conducted).
399 See e.g., Press Release, U.S. Dep’t of Just.,
Justice Department Secures Settlement with Rite
Aid Corporation to Make Its Online Covid–19
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Many covered entities are currently
relying on Section 508 standards
promulgated by the Access Board or
Web Content Accessibility Guidelines
(WCAG) developed through the
Worldwide Web Consortium’s (W3C)
Web Accessibility Initiative to ensure
that their ICT is accessible to
individuals with disabilities.400
Additionally, multiple states have laws
or policies addressing accessibility of
ICT with which entities covered by
those statutes must comply.401 Over
time, the feasibility of technological
applications and solutions has
continued to develop and dramatically
change the way the public interacts with
health programs and activities.
Proposed paragraph (a) requires
covered entities to ensure that their
health programs and activities provided
through ICT are accessible to
individuals with disabilities, unless
doing so would result in undue
financial and administrative burdens or
a fundamental alteration in the nature of
the health programs or activities. If an
action required to comply with this
subpart would result in such an
alteration or burdens, a covered entity is
required to take any other action that
would not result in such an alteration or
burdens but would nevertheless enable,
to the maximum extent possible,
individuals with disabilities to receive
the benefits or services of the health
program or activity provided by the
covered entity.
Proposed paragraph (b) requires
recipients and State Exchanges to
ensure that their health programs and
activities provided through websites
and mobile applications comply with
the requirements of Section 504 as
interpreted in a manner consistent with
Title II of the ADA. Both the 2020 Rule
and the 2016 Rule have the same
provision as it applies to recipient and
State Exchange websites. We propose to
modify this provision by extending it to
mobile applications in addition to
websites.
Given the heightened impact ICT has
on individuals with disabilities in
health programs and activities, as
Vaccine Portal Accessible to Individuals with
Disabilities (Nov. 1, 2021), https://www.justice.gov/
usao-mdpa/pr/justice-department-securessettlement-rite-aid-corporation-make-its-onlinecovid-19.
400 See Press Release, U.S. Dep’t of Just., Justice
Department Issues Web Accessibility Guidance
Under the Americans with Disabilities Act (Mar. 18,
2022), https://www.justice.gov/opa/pr/justicedepartment-issues-web-accessibility-guidanceunder-americans-disabilities-act.
401 Policy & Management: State Policy,
Section508.gov, https://www.section508.gov/
manage/laws-and-policies/state/ (last visited June
15, 2022).
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evidenced by COVID–19, OCR is
seeking comments on whether the
Section 1557 rule should include a
provision requiring covered entities to
comply with specific accessibility
standards, such as the Web Content
Accessibility Guidelines (WCAG)
developed by the Web Accessibility
Initiative. Additionally, OCR seeks
comments on whether to adopt a safe
harbor provision under which covered
entities that are in compliance with
established specific accessibility
standards are deemed in compliance
with proposed paragraphs (a) and (b) of
this section; whether OCR should
require covered entities to comply with
the most recent edition of a published
standard; and the timeline necessary for
covered entities to come into
compliance with a new standard.
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Requirement To Make Reasonable
Modifications (§ 92.205)
Proposed § 92.205 requires covered
entities to make reasonable
modifications to policies, practices, or
procedures when such modifications are
necessary to avoid discrimination on the
basis of disability, unless the covered
entity can demonstrate that making the
modifications would fundamentally
alter the nature of the health program or
activity. This provision is the same as
§ 92.105 of the 2020 Rule and former
§ 92.205 of the 2016 Rule. For the
purposes of this section, the term
‘‘reasonable modifications’’ shall be
interpreted in a manner consistent with
the term as set forth in the regulation
implementing Title II of the ADA at 28
CFR 35.130(b)(7).402
Equal Program Access on the Basis of
Sex (§ 92.206)
The Department proposes to include a
section clarifying covered entities’
obligation to ensure equal access to their
health programs and activities without
discrimination on the basis of sex,
including pregnancy, sexual orientation,
gender identity, and sex
characteristics.403 This provision
primarily relates to covered entities that
are directly engaged in the provision of
health care services, such as hospitals,
physical and mental health care
providers, and pharmacies. While the
2016 Rule included a section on equal
program access on the basis of sex, the
2020 Rule does not include an
analogous provision. As Section 1557 is
the only Federal civil rights law
explicitly prohibiting sex discrimination
402 See discussion supra § 92.3 (addressing need
for parity between Section 504 and the ADA).
403 See discussion supra section II.B. (The 2020
Rule’s Preamble Does Not Reflect Recent
Developments in Civil Rights Law).
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in health programs and activities, the
Department believes that it is beneficial
to both covered entities and the public
to have additional regulatory clarity.
Nondiscrimination by covered entities
in the provision or administration of
health insurance coverage and other
health-related coverage is addressed in
proposed § 92.207.
Proposed § 92.206(a) describes a
covered entity’s general obligation to
provide individuals equal access to the
covered entity’s health programs or
activities without discrimination on the
basis of sex. The Department proposes
paragraphs (b)(1)–(4) to clarify certain
types of discriminatory actions that
would be prohibited for a covered entity
in its provision of access to health
programs or activities.
As is true for any claim of
discrimination under this proposed
rule, and consistent with the
Department’s standard practice for
investigating such claims, OCR may use
the tools of longstanding civil rights
case law in analyzing claims of
discrimination under paragraph (b).
These tools include, but are not limited
to, the multi-factor test articulated in
Arlington Heights,404 and the
McDonnell Douglas 405 burden-shifting
framework. Explained in great depth in
the DOJ’s Title VI Legal Manual,
Arlington Heights is a method of proof
that uses a number of different types of
circumstantial evidence that, taken
collectively, can demonstrate that the
covered entity acted, at least in part,
because of a protected basis. Under this
test, evidence of disparate impact can be
one piece of evidence that is considered
in determining whether there is
intentional discrimination. This
framework is most commonly applied in
cases alleging discrimination against a
group.406 The McDonnell Douglas
burden-shifting framework, however, is
most commonly applied in cases
alleging discrimination in individual
instances and is an inferential method
of proof that is used to show that a
defendant treated similarly situated
individuals differently because of a
protected basis.407 Under McDonnell
Douglas, where there is a prima facie
case of discrimination against a covered
entity, that covered entity must
articulate a legitimate,
nondiscriminatory reason for its actions.
This legitimate, nondiscriminatory
reason would be a defense against the
404 Vill. of Arlington Heights v. Metro. Housing
Dev. Corp., 429 U.S. 252, 266–68 (1977).
405 McDonnell Douglas Corp. v. Green, 411 U.S.
792 (1973).
406 U.S. Dep’t of Just., Title VI Legal Manual, sec.
VI.B.2.
407 Id. at sec. VI.B.3.
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47865
claim of discrimination, unless it can be
established that this reason is in fact a
mere pretext for prohibited
discrimination.
Proposed paragraph (b)(1) provides a
general prohibition on the denial or
limitation of health services, including
those that are offered exclusively to
individuals of one sex, to an individual
based on the individual’s sex assigned
at birth, gender identity, or gender
otherwise recorded. The text of this
proposed paragraph is similar to former
§ 92.206 of the 2016 Rule, which
provided that ‘‘a covered entity may not
deny or limit health services that are
ordinarily or exclusively available to
individuals of one sex, to a transgender
individual based on the fact that the
individual’s sex assigned at birth,
gender identity, or gender otherwise
recorded is different from the one to
which such health services are
ordinarily or exclusively available.’’ 408
The 2020 Rule does not include a
similar provision. The Department
proposes to not include the word
‘‘transgender’’ in this proposed
provision. This approach recognizes
that the form of discrimination
discussed herein may impact a range of
individuals, including transgender
people, individuals with intersex
conditions, or people who may need
these services but do not identify as
transgender.
The Department’s review of the
literature indicates that this provision is
warranted based on continued
discrimination experienced by
transgender and gender non-conforming
individuals as they seek basic medical
care. For example, transgender men who
are pregnant experience significant
forms of ‘‘discrimination, stigma, and
erasure’’ when navigating pregnancy
and prenatal care, particularly because
pregnancy and childbirth are often
treated as something exclusively
experienced by cisgender women.409
Under this provision, a covered entity
that routinely provides gynecological or
obstetric care could not deny an
individual a pelvic exam or pregnancyrelated care because the individual is a
transgender man or nonbinary person
assigned female at birth, if the entity
otherwise provides that care to
cisgender individuals. Similarly, a
community clinic that receives funding
from the Department could not refuse to
provide a transgender woman a prostate
cancer screening because her sex is
408 See
81 FR 311375, 31471 (May 18, 2016).
Besse et al., Experiences with
Achieving Pregnancy and Giving Birth Among
Transgender Men: A Narrative Literature Review, 93
Yale J. of Biology & Med. 517, 518 (2020).
409 Margaret
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listed female in her electronic health
record, if the entity otherwise provides
these screenings to cisgender
individuals.
Proposed paragraph (b)(2) prohibits
covered entities from denying or
limiting a health care professional’s
ability to provide health services on the
basis of a patient’s sex assigned at birth,
gender identity, or gender otherwise
recorded. This provision recognizes that
prohibited discrimination may take the
form of attempted restrictions on
individual providers, such as attending
physicians, that have the effect of
discriminating against patients, in
addition to discriminatory actions that
target patients directly. This is similar to
Title VI’s limited application to
employment when a recipient’s
‘‘discrimination has a secondary effect
on the ability of beneficiaries to
participate meaningfully in and/or
receive the benefits of a federally
assisted program in a nondiscriminatory
manner.’’ 410
Under this provision, a covered entity
is also prohibited from punishing or
disciplining a provider for providing
clinically appropriate care where doing
so would have the impact of limiting
that provider’s ability to provide such
care on the basis of a patient’s assigned
sex at birth, gender identity, or gender
otherwise recorded. As with all
proposed paragraphs in this section, this
provision does not require covered
entities to perform services outside of
their specialty area. However,
restrictions by covered entities on the
ability of providers to prescribe or
provide care based on their patient’s
gender identity or sex assigned at birth
would likely constitute prohibited
discrimination in violation of this rule.
Proposed paragraph (b)(3) would
prohibit a covered entity from applying
any policy or practice of treating
individuals differently or separating
them on the basis of sex in a manner
that subjects any individual to more
than de minimis harm. The 2016 Rule
provided, at former § 92.101(b)(3)(iv),
that sex-specific health programs and
activities were allowable only where the
covered entity could ‘‘demonstrate an
exceedingly persuasive justification,
that is, that the sex-specific health
program or activity is substantially
related to the achievement of an
important health-related or scientific
objective.’’ The 2020 Rule repealed this
provision, finding that the provision
‘‘placed an unjustified burden on sexspecific health programs and activities
conducted by private entities’’ by
410 U.S.
Dep’t of Just., Title VI Legal Manual, sec.
X.A.
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adopting the Equal Protection standard
that otherwise applies only to
governmental actions that discriminate
on the basis of sex.411 The Department
has considered the approaches taken in
the 2016 and 2020 Rules and believes
that while it is important to include a
provision on this issue, the
Constitutional standard is not the most
appropriate for a regulation that applies
to governmental and non-governmental
actors. Rather, we believe the standard
proposed now is the more appropriate
approach.
Although differential treatment on the
basis of sex is generally prohibited, the
Department acknowledges that there are
certain circumstances in which Section
1557 does not prohibit separation by sex
or differential medical treatment on the
basis of sex, namely, where it does not
cause more than de minimis harm. A
sex-based distinction that has only a
minimal impact is not a form of
‘‘discrimination’’ that Congress
intended to prohibit,412 and an
individual shall not be deemed subject
to discrimination under this part by
reason of the fact that an otherwise
lawful health program or activity has
chosen to utilize such sex-based
distinctions consistent with the
requirements of this rule. For example,
the practice of assigning patients to
dual-occupancy rooms in hospitals and
in-patient treatment facilities on the
basis of sex is not, standing alone, a
form of discrimination.
However, the Department may still
find that a covered entity violates
Section 1557 if it implements the sexbased distinction in a way that
constitutes discrimination, by imposing
more than de minimis harm upon a
particular individual. This is what Title
IX requires.413
Discriminatory harm that is more than
de minimis may include any adverse
effect on a person’s equal access to or
participation in a covered entity’s health
program or activity based on sex. This
411 85
FR 37160, 37196 (June 19, 2020).
e.g., Oncale v. Sundowner Offshore
Servs., Inc., 523 U.S. 75, 81 (1998) (Title VII does
not reach non-harmful ‘‘differences in the ways
men and women routinely interact with’’ each
other); see also Burlington N. & Santa Fe Ry. Co.
v. White, 548 U.S. 53, 59–60 (2006) (‘‘No one doubts
that the term ‘discriminate against’ refers to
distinctions or differences in treatment that injure
protected individuals.’’); Threat v. City of
Cleveland, 6 F.4th 672, 678 (6th Cir. 2021) (‘‘To
‘discriminate’ reasonably sweeps in some form of
an adversity and a materiality threshold.’’).
413 See Peltier v. Charter Day Sch., Inc., Nos. 20–
1001, 20–1023, 2022 WL 2128579, at *16 (4th Cir.
June 14, 2022) (en banc) (‘‘for the plaintiffs to
prevail under Title IX, they must show that . . . the
challenged action caused them harm, which may
include ‘emotional and dignitary harm’ ’’ (internal
citation omitted)).
412 See,
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provision does not, however, prohibit a
covered entity from treating an
individual for conditions that may be
specific to their sex characteristics. For
example, it would be permissible for an
emergency department to treat a
transgender man with a positive human
chorionic gonadotropin (pregnancy) test
as a pregnant person, even though
pregnancy is generally associated with
‘‘female’’ sex characteristics, such as
having a functioning uterus and
ovaries.414 Similarly, sex-specific
clinical trials may be permissible based
upon the scientific purposes of the
study, i.e., trials based on a particular
sex-characteristic(s), such as those that
test treatments for specific conditions or
that evaluate differences in responses to
treatment regimens among individuals
with different sex characteristics. In
evaluating a complaint of
discrimination challenging a covered
entity’s sex-specific health program or
activity, OCR may consider a variety of
factors relevant to the particular health
program or activity.
In particular, this provision would
prohibit the adoption of a policy, or
engaging in a practice, that prevents any
individual from participating in a
covered entity’s health program or
activity consistent with their gender
identity. The 2016 Rule required that
covered entities ‘‘treat individuals
consistent with their gender identity’’ at
former § 92.206; as discussed
previously, the 2020 Rule preamble
indicated that Section 1557 likely did
not prohibit discrimination on the basis
of gender identity as a form of
prohibited sex discrimination, and
therefore did not include a similar
provision. The Department believes this
provision is necessary to better
effectuate Section 1557’s purpose: to
eliminate sex discrimination in a range
of health programs and activities.
Reading Section 1557’s prohibition of
sex discrimination consistently with the
reasoning in Bostock, discrimination on
the basis of gender identity necessarily
involves consideration of an
individual’s sex—even if that term is
narrowly defined—and Section 1557’s
prohibition covers discrimination on
that basis. For example, a hospital that
assigns patients to dual-occupancy
rooms based on sex would be prohibited
from requiring a transgender woman to
share a room with a cisgender man,
414 See, e.g., Daphna Strousma et al., The Power
and Limits of Classification—A 32-Year-Old Man
with Abdominal Pain, 380 N. Eng. J. Med. 1885
(2019), https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC7395710/pdf/nihms-1609250.pdf.
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regardless of how her sex is recorded in
her insurance or medical records.415
Proposed paragraph (b)(4) prohibits a
covered entity from denying or limiting
health services sought for the purpose of
gender-affirming care that the covered
entity would provide to a person for
other purposes if the denial or
limitation is based on a patient’s sex
assigned at birth, gender identity, or
gender otherwise recorded.
This preamble generally uses the
phrase ‘‘gender transition or genderaffirming care.’’ Relevant clinical
guidelines acknowledge that not all
individuals for whom such care is
clinically appropriate will specifically
identify as transgender, nor will all
gender-affirming care specifically be
related to transition from one binary
gender to another.416 For example,
people seeking gender-affirming care
may refer to their gender identity using
terms other than ‘‘transgender,’’ such as
‘‘nonbinary,’’ ‘‘gender nonconforming,’’
‘‘genderqueer,’’ or ‘‘genderfluid.’’
Individuals using any of these terms
may have a gender dysphoria diagnosis
and seek clinically appropriate genderaffirming care. A person’s use of
particular identity terminology is not
determinative of whether the care in
question is appropriate.
There also may be variations in the
types of health services that are sought
or are clinically appropriate for each
person (e.g., some people undergo
hormone therapy as part of gender
transition but do not seek any surgical
care).417 Additionally, some transgender
people might not seek or require health
interventions as part of their gender
transition or gender-affirmation process.
Nothing in this preamble or the
regulatory text is intended to limit the
application of provisions discussing
gender-affirming care or transitionrelated care based on whether an
individual uses particular terms to
describe their gender identity or seeks
only certain types of gender-affirming or
transition-related care. The Department
welcomes comments on this choice of
terminology in the regulatory text,
particularly from individuals seeking
and providing such care.
Importantly, this provision does not
require health care professionals to
perform services outside of their normal
415 See, e.g., Bulletin, U.S. Dep’t of Health &
Human Servs., The Brooklyn Hospital Center
Implements Non-Discriminatory Practices to Ensure
Equal Care for Transgender Patients (July 14, 2015),
https://www.hhs.gov/sites/default/files/ocr/
civilrights/activities/agreements/TBHC/
statement.pdf.
416 WPATH Standards, supra note 139, at pp. 8–
9.
417 Id.
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specialty area; therefore a provider that
declines to provide services outside its
specialty area would have a legitimate,
nondiscriminatory reason for its action.
This is consistent with the Department’s
position under Section 504 regarding
medical specialization. As explained in
Appendix A to the Department’s Section
504 implementing regulation, ‘‘[a] burn
treatment center need not provide other
types of medical treatment to
[individuals with disabilities] unless it
provides such medical services to
[persons without disabilities]. It could
not, however, refuse to treat the burns
of a deaf person because of his or her
deafness.’’ 418 This provision also does
not compel a provider to prescribe a
specific treatment that the provider
decides not to offer after making a
nondiscriminatory bona fide treatment
decision. For example, a family practice
covered by the rule would not be
required to provide transition-related
surgery where surgical care is not
within its normal area of practice. Nor
would the proposed rule require a
pediatrician to prescribe hormone
blockers for a prepubescent gendernonconforming minor if that health care
provider concluded, pursuant to a
nondiscriminatory bona fide treatment
decision, that social transition was the
clinically indicated next step for that
child.
By contrast, a gynecological surgeon
may be in violation of the rule if they
accept a referral for a hysterectomy but
later refuse to perform the surgery upon
learning the patient is a transgender
man. If OCR were to receive a complaint
in a case such as this, it would evaluate
whether the provider had a legitimate
basis for concluding that the surgery
would not be clinically appropriate for
the patient. If the surgeon invokes such
a justification, OCR would make a
determination as to whether the reason
was a pretext for discrimination. OCR
would also consider the application of
Federal conscience and religious
freedom laws, where relevant.
Proposed paragraph (c) provides that
nothing in this section requires the
provision of any health service where
the covered entity has a legitimate,
nondiscriminatory reason for denying or
limiting that service, including where
the covered entity reasonably
determines that such health service is
not clinically appropriate for that
particular individual. However, a
provider’s view that no gender
transition or other gender-affirming care
can ever be beneficial for such
individuals (or its compliance with a
state or local law that reflects a similar
418 See
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judgment) is not a sufficient basis for a
judgment that a health service is not
clinically appropriate. Paragraph (c) is
consistent with the general principle in
nondiscrimination law that covered
entities facing allegations of
discrimination have the opportunity to
articulate a legitimate,
nondiscriminatory basis for their
challenged action or practice.419 For
example, a covered entity would not be
required to perform a cervical exam on
an individual who does not have a
cervix, or to perform a prostate exam on
an individual who does not have a
prostate.
In evaluating whether a facially sexneutral asserted basis is pretextual, OCR
may consider whether a determination
that care is not clinically appropriate is
based on generally accepted scientific or
medical standards. For example, a clinic
could not raise a defense under this
provision if they denied a transgender
woman a prostate exam based on the
provider’s belief that prostate exams are
never clinically appropriate for women,
if in fact the particular patient has a
prostate. Nor would this provision
provide a defense to a provider denying
testosterone therapy to an intersex
woman with complete androgen
insensitivity syndrome based on a
categorical belief that such therapy is
never clinically appropriate for
women.420
Similarly, OCR recognizes that
providers often need to make inquiries
about a patient’s sex-related medical
history, health status, or physical traits
related to sex in the course of providing
care. Such inquiries are not per se
discriminatory, even where they touch
on intimate or sensitive matters, but
should be related to the underlying
condition. For example, it is not
discriminatory—i.e., it does not result in
more than de minimis harm—for a
provider treating a patient presenting
with symptoms consistent with an
ectopic pregnancy to inquire about the
possibility that the patient could be
pregnant, regardless of that patient’s
gender identity. However, where they
are relevant to allegations of
419 See, e.g., McDonnell Douglas Corp. v. Green,
411 U.S. 792, 802 (1973); U.S. Dep’t of Just., Title
IX Legal Manual, sec. IV.A.1; id. at sec. VI.B.3; see
also Vill. of Arlington Heights v. Metro. Hous. Dev.
Corp., 429 U.S. 252 (1977) (enumerating factors to
be considered in evaluating whether a policy or
practice is motivated by discriminatory intent); U.S.
Dep’t of Just., Title VI Legal Manual, sec. VI.B.2.
420 See Wiebke Birnbaum et al., Oestrogen Versus
Androgen in Hormone-Replacement Therapy for
Complete Androgen Insensitivity Syndrome: A
Multicentre, Randomised, Double-Dummy, DoubleBlind Crossover Trial, 10 Lancet Diabetes
Endocrinol. 771 (2018), https://
pubmed.ncbi.nlm.nih.gov/30075954/.
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discrimination, OCR may consider
whether such inquiries are related to
providing the care sought. Where such
inquiries do not have a relationship to
the care provided, or where they are
made in a manner that is harassing,
hostile, or evinces disregard for a
patient’s privacy, OCR may consider
whether a provider’s inquiries may be
evidence of discrimination. For
example, if a provider refused to
provide treatment for a broken arm
unless the patient answered questions
about their history of genital surgery,
OCR would consider whether there was
any medical rationale for asking the
question or whether it was mere pretext
for discrimination, given the lack of
connection between the question and
the care being provided.421 Similarly, a
provider’s repeated questions about
whether a patient had had breast
augmentation surgery could be
considered as evidence of
discrimination where such questions
were unrelated to the care provided,
especially if the manner of the
questioning had other indicia of
harassment. Where relevant, OCR will
consider the totality of the
circumstances in determining whether
overbroad, irrelevant, or hostile
inquiries may constitute evidence of
discrimination.
Proposed paragraph (d) provides that
the enumeration of specific forms of
discrimination in paragraph (b) does not
limit the general applicability of the
prohibition in paragraph (a) of this
section.
The Department believes that the
provisions in proposed § 92.206 are
consistent with, and in furtherance of,
Section 1554 of the ACA, which
prohibits the Secretary of HHS from
promulgating a regulation that
‘‘interferes with communications
regarding a full range of treatment
options between patient and the
provider,’’ or ‘‘restricts the ability of
health care providers to provide full
disclosure of all relevant information to
patients making health care
decisions.’’422 The provision as written
supports and encourages health care
providers’ ability to discuss a full range
of treatment options with their patients
and in no way restricts providers’ ability
421 See, e.g., David Oliver, ‘Being Transgender Is
Not a Medical Condition’: The Meaning of Trans
Broken Arm Syndrome, USA Today (last updated
Mar. 31, 2022), https://www.usatoday.com/story/
life/health-wellness/2021/07/27/trans-broken-armsyndrome-what-it-how-combat-discriminationhealth-care/8042475002/; Douglas Knutson et al.,
‘‘Trans Broken Arm’’: Health Care Stories from
Transgender People in Rural Areas, 7 J. of Rsch. on
Women & Gender 30 (2016), https://journals.tdl.org/
jrwg/index.php/jrwg/article/download/97/50.
422 42 U.S.C. 18114(3), (4).
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to share the range of risks and benefits
associated with each treatment option.
As discussed throughout this section,
the provisions here do not compel a
particular treatment for any given
condition; rather, this section prohibits
health care providers from
discriminating against individuals on
the basis of sex, including gender
identity. Gender-affirming care, like all
medical care, should follow clinical
practice guidelines and professional
standards of care.423 Informed consent
to any medical treatment is both a legal
and ethical standard, regardless of the
type of care, and serves as a basis for
shared decision making.424 When
providing gender-affirming medical care
for minors, informed consent involves
discussions among providers, minors,
and parents or guardians.425
We seek comment on this section,
including whether it adequately
addresses the forms of discrimination
faced by individuals on the basis of sex
(including pregnancy, sexual
orientation, gender identity, and sex
characteristics) when seeking access to
and participating in health programs
and activities; whether the proposed
regulation text captures the policies set
forth in this preamble; what sex-based
distinctions, if any, should be permitted
in the context of health programs and
activities; and the standards for
permitting such distinctions that do not
result in more than de minimis harm.
We also invite comment on whether
additional regulatory language should
be added to specifically address the
circumstance in which a provider offers
a particular health treatment, service or
procedure for certain purposes, but
refuses to offer that same treatment,
service or procedure for gendertransition or other gender-affirming care
purposes because they believe it would
not be clinically appropriate.
Nondiscrimination in Health Insurance
Coverage and Other Health-Related
Coverage (§ 92.207)
Proposed § 92.207 prohibits
discrimination on the basis of race,
color, national origin, sex, age, or
423 See e.g., WPATH Standards, supra note 139;
Wylie Hembree et al., Endocrine Treatment of
Gender-Dysphoric/Gender-Incongruent Persons: An
Endocrine Society Clinical Practice Guideline, 102
J. Clinical Endocrinology & Metabolism 3869
(2017), https://academic.oup.com/jcem/article/102/
11/3869/4157558.
424 Am. Med. Ass’n, Informed Consent, https://
www.ama-assn.org/delivering-care/ethics/informedconsent (last visited June 15, 2022).
425 Hilary Cass, The Cass Review, Independent
Review of Gender Identity Services for Children
and Young People: Interim Report (2022), https://
cass.independent-review.uk/publications/interimreport/.
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disability in the provision or
administration of health insurance
coverage and other health-related
coverage. This proposed section would
apply to all covered entities that provide
or administer health insurance coverage
or other health-related coverage that
receive Federal financial assistance, and
the Department in the administration of
its health-related coverage programs.
This is consistent with the 2016 Rule,
which similarly prohibited
discrimination in health-related
insurance and other health-related
coverage under former § 92.207,
including in marketing practices and
benefit design. The 2020 Rule repealed
former § 92.207 in its entirety, stating
that an additional or separate section on
health insurance was not necessary.426
Despite removing former § 92.207, the
preamble to the 2020 Rule stated that
OCR would continue to investigate
discrimination in health insurance,
including in benefit design.427
In rescinding former § 92.207, the
2020 Rule creates a lack of clarity for
covered entities as to what constitutes
prohibited discrimination in health
insurance and health-related
coverage.428 This uncertainty creates
confusion regarding what conduct is
prohibited and renders Section 1557
less effective at combatting
discrimination in health insurance and
other health-related coverage, resulting
in greater risk for covered entities and
less protection for people who need
health care and who are protected by
Section 1557 against discrimination.
The statutory text of Section 1557
demonstrates Congress’ intent to apply
Section 1557 nondiscrimination
requirements to health insurance and
other health-related coverage where an
entity receives Federal financial
assistance and, therefore, the
Department proposes to reinstate
specific provisions related to
nondiscrimination in health insurance
and other health-related coverage in the
Section 1557 rule. Robust enforcement
of such nondiscrimination requirements
for health insurance and other healthrelated coverage practices is critical to
ensure individuals’ ability to receive the
health services that they need,
unencumbered by discriminatory
conduct. Such discriminatory conduct
426 85
FR 37160, 37201 (June 19, 2020).
at 37177, 37201.
428 See Valarie K. Blake, Health Care Civil Rights
Under Medicare for All, 72 Hastings L.J. 773, 800
(2021), https://repository.uchastings.edu/cgi/
viewcontent.cgi?article=3925&context=hastings_
law_journal (stating the 2020 Rule ‘‘eliminated all
of the specific guidance on what counts as
insurance discrimination, leaving the issue to OCR
and the courts’’).
427 Id.
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reduces both access to care and the
quality of care received on the basis of
race, color, national origin, sex, age, or
disability. The Department’s proposal to
reinstate the provisions is consistent not
only with the ACA, but with the
Administration’s mission to enhance the
health and well-being of all
Americans.429
E.O. 14009, ‘‘Strengthening Medicaid
and the Affordable Care Act,’’ states that
it is the Administration’s policy to
‘‘protect and strengthen Medicaid and
the ACA and to make high-quality
health care accessible and affordable for
every American.’’ 430 Of particular
relevance to Section 1557, E.O. 14009
requires agencies to examine policies or
practices that may undermine
protections for people with pre-existing
conditions under the ACA, may present
‘‘unnecessary barriers’’ to individuals
seeking access to Medicaid or ACA
coverage, and may reduce the
affordability of coverage.431
Additionally, E.O. 14070, ‘‘Continuing
To Strengthen Americans’ Access to
Affordable, Quality Health Coverage,’’
states that agencies ‘‘. . . shall review
agency actions to identify ways to
continue to expand the availability of
affordable health coverage, to improve
the quality of coverage, to strengthen
benefits, and to help more Americans
enroll in quality health coverage.’’ 432 By
specifying that health insurance and
other health-related coverage offered
through the Exchanges and Medicaid
must be provided in a
nondiscriminatory manner, proposed
§ 92.207 would strengthen access to
health care and prevent unnecessary
barriers in accessing coverage consistent
with E.O. 14009 and E.O. 14070.
As discussed previously, historically
marginalized communities
disproportionally suffer from worse
health outcomes and higher rates of
discrimination in accessing health care
than other communities.433 By
addressing the prevention of
discrimination in health insurance and
other health-related coverage, proposed
§ 92.207 also aligns with the
Administration’s goal of achieving
health equity for these populations.434
429 Mission Statement, U.S. Dep’t of Health &
Human Servs., https://www.hhs.gov/about/
strategic-plan/introduction/#mission
(last updated Mar. 28, 2022).
430 86 FR 7793 (Jan. 28, 2021) (revoking E.O.
13765, ‘‘Minimizing the Economic Burden of the
Patient Protection and Affordable Care Act Pending
Repeal,’’ 82 FR 8351 (Jan. 20, 2017), which was
cited as a justification for the 2020 Rule).
431 Id. at 7794.
432 87 FR 20689, 20690 (Apr. 8, 2022).
433 See discussion supra section II.D. (on
advancing health equity).
434 See, e.g., E.O. 13985, 86 FR 7009 (2021).
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Adopting proposed § 92.207,
particularly paragraphs (b)(3)–(5),
would establish specific provisions to
protect gender-diverse individuals from
discrimination in health insurance and
other health-related coverage.
Proposed paragraph (a) provides a
general nondiscrimination requirement,
and proposed paragraph (b) provides
specific examples of prohibited actions.
Proposed paragraph (b)(1) specifies
that covered entities are prohibited from
denying, cancelling, limiting, or
refusing to issue or renew health
insurance coverage or other healthrelated coverage, or denying or limiting
coverage of a claim, or imposing
additional cost sharing or other
limitations or restrictions on coverage,
on the basis of race, color, national
origin, sex, age, or disability. This
language is identical to the 2016 Rule
and would prohibit health insurance
issuers and other covered entities 435
from taking discriminatory actions
related to coverage.
Proposed paragraph (b)(2) prohibits
marketing practices or benefit designs
that discriminate on the basis of race,
color, national origin, sex, age, or
disability. This is consistent with both
the 2016 Rule, which contained the
same regulatory language, as well as the
assurance in the preamble of the 2020
Rule that OCR will continue to
investigate discrimination in health
insurance or other health coverage
benefit design, despite the repeal of
former § 92.207.436 Reinstating this
provision will provide clarity and notice
to covered entities and the public that
Section 1557 continues to prohibit
discriminatory marketing practices and
benefit designs on the bases specified
under Section 1557. This provision is
independent of other regulations that
separately prohibit discrimination in
health insurance or other health-related
coverage.437 While these
435 A variety of entities may be considered
covered entities subject to proposed § 92.207,
including but not limited to health insurance
issuers, sponsors of group health plans, Medicare
Advantage organizations, Medicare Part D plan
sponsors, Medicaid managed care organizations,
pharmacy benefit managers, third party
administrators (as part of a covered entity’s
operations when it meets the criteria in paragraph
(b) of the definition of ‘‘health program or activity’’
in proposed § 92.4), and the Department. For
simplicity, we simply refer to ‘‘health insurance
issuers’’ or ‘‘issuers’’ throughout the preamble, but
please note that other covered entities may also be
subject to the proposed section under discussion.
436 See 85 FR 37177, 377201.
437 See, e.g., 42 CFR 422.100(f)(2)–(3), § 422.110
(Medicare Advantage); 42 CFR 423.2262(a)(1)(iv)
(Part D); 42 CFR 438.3(d), (f) (Medicaid); 42 CFR
600.405(d) (Basic Health Program); 45 CFR
147.104(e) (group and individual health insurance
markets); 45 CFR 155.120(c) (Exchanges); 45 CFR
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nondiscrimination requirements
complement each other, covered entities
are required to independently comply
with all applicable regulations.
The terms ‘‘benefit design’’ and
‘‘marketing practices’’ encompass an
array of features. To avoid being overly
prescriptive or unintentionally
inconsistent with other departmental
regulations,438 the Department does not
propose defining these terms in this rule
and intends to interpret them broadly.
Examples of benefit design features
include, but are not limited to, coverage,
exclusions, and limitations of benefits;
prescription drug formularies; cost
sharing (including copays, coinsurance,
and deductibles); utilization
management techniques (such as step
therapy and prior authorization);
medical management standards
(including medical necessity standards);
provider network design; and
reimbursement rates to providers and
standards for provider admission to
participate in a network.
Marketing practices would broadly
include, for example, activities designed
to encourage individuals to participate
or enroll in particular health plans or
certain types of plans, or to discourage
them from doing so, and activities that
steer or attempt to steer individuals
towards or away from a particular plan
or certain types of plans.439 For
example, covered entities that avoid
advertising in areas populated by a
majority of people of color to reduce the
156.125(a)–(b) (essential health benefits); 45 CFR
156.200(e), § 156.225(b) (qualified health plans).
438 Other departmental and Federal regulations
governing private health insurance and public
health coverage refer to ‘‘benefit design’’ and
‘‘marketing practices.’’ See, e.g., 45 CFR 147.104(e),
§ 156.20, § 156.125(a) (health insurance issuers); 45
CFR 156.110(d), § 156.125(a), § 156.200(b)(3),
§ 156.225(b) (qualified health plans); 45 CFR
156.110(d), § 156.111(b)(2)(v) (essential health
benefits benchmark plans); 42 CFR 422.100(f)(3)
(Medicare Advantage); 42 CFR 422.2260–15
(Medicare Part D marketing requirements); 42 CFR
423.882, § 423.894(d) (Medicare retiree prescription
drug plans); 42 CFR 440.347(e) (Medicaid
benchmark plans); 42 CFR 600.405 (Basic Health
Program); 29 CFR 2510.3–40(c)(1)(iv)(A) (employee
welfare benefit plan under Employee Retirement
Income Security Act of 1974).
439 For simplicity and for purposes of this
preamble only, we use the term ‘‘health plan’’ or
‘‘plan’’ interchangeably to refer generally to health
insurance coverage and other health coverage that
is subject to this proposed rule. As used in this
preamble, ‘‘health plan’’ or ‘‘plan’’ may include
health insurance coverage offered in the group and
individual markets, group health plans, Medicare
Advantage plans, Medicare Part D plans, and
Medicaid plans that are subject to this proposed
rule. We do not intend ‘‘health plan’’ or ‘‘plan’’ to
be regulatory terms in this proposed regulation or
to replace any existing or proposed term in Federal
law.
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enrollment of people of color in their
plans could violate this provision.440
By clarifying that health insurance
and other health-related coverage must
not employ discriminatory benefit
design or marketing practices, proposed
paragraph (b)(2) would further the
ACA’s goals of expanding access to
affordable and quality health care and
would be consistent with existing
departmental regulations governing
health insurance and other healthrelated coverage that similarly prohibit
such discriminatory practices. The ACA
prohibits the use of many formerly
standard health insurance industry
practices in many types of coverage that
resulted in higher costs or denial of
coverage or benefits for individuals with
disabilities and others, including
practices such as medical underwriting
and premium rating 441 and pre-existing
condition exclusions.442 Its prohibition
of discrimination in health-related
coverage furthers the same goals.
We acknowledge that covered entities
have discretion in designing their
benefit packages, and we do not require
entities to cover any particular
procedure or treatment. When assessing
complaints alleging discrimination in
benefit design, OCR will evaluate on a
case-by-case basis whether a particular
design feature or coverage requirement
is discriminatory. Where appropriate,
OCR will determine if there is a
legitimate, nondiscriminatory
justification for the particular benefit
design feature or coverage requirement.
This justification cannot be pretext for
discrimination. We elaborate further
about how OCR will analyze claims of
discrimination in benefit design later in
this section.443 As we articulate in that
discussion,444 this rule is not intended
to prohibit covered entities from
utilizing nondiscriminatory medical
management techniques.
Proposed paragraphs (b)(3) through
(5) address benefit designs that
impermissibly limit coverage based on a
person’s sex at birth, gender identity, or
gender otherwise recorded. The
440 See Sidney D. Watson, Section 1557 of the
Affordable Care Act: Civil Rights, Health Reform,
Race, and Equity, 55 How. L.J. 855, 868 (2012),
https://heinonline.org/HOL/LandingPage?handle=
hein.journals/howlj55&div=33&id=&page=.
441 42 U.S.C. 300gg (prohibiting discriminatory
premium rates by limiting rating factors to only
include family size, geographic rating area, age, and
tobacco use); 300gg–1 (requiring guaranteed
availability of coverage to any individual or
employer applying for coverage); 300gg–2 (requiring
guaranteed renewability of coverage at the option of
the plan sponsor or individual).
442 42 U.S.C. 300gg–3.
443 See discussion infra under this section on
Benefit Design.
444 See discussion infra under this section on
paragraph (c).
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Department believes it is important to
address discrimination faced by
transgender individuals, including
nonbinary and gender diverse
individuals, in accessing coverage of
health services.445 Discrimination
against transgender people in health
insurance and other health-related
coverage remains pervasive, especially
for individuals who experience
intersectional discrimination, such as
individuals who experience both
transphobia and racism.446 As reported
in a 2020 study of self-identified LGBTQ
adults, 38 percent of transgender
respondents—and 52 percent of
transgender respondents of color—said
that they had been denied hormone
therapy coverage by their health insurer,
and 43 percent reported being denied
coverage for surgery for their
transition.447
OCR believes the approach proposed
in § 92.207(b)(3) through (5), which is
similar to provisions in the 2016 Rule,
will once again prove vital in helping to
address discrimination faced by
individuals whose sex assigned at birth
is different from their gender identity in
accessing coverage of health services,
including health services that are
medically necessary,448 and is
consistent with the legal principle that
discrimination on the basis of sex
includes discrimination on the basis of
gender identity.449 As discussed
regarding how the Department will
evaluate claims of discrimination under
proposed § 92.206(b), the Department
will look for direct or circumstantial
evidence of discrimination when
considering claims of intentional
discrimination. Direct evidence may
come in the form of an express
classification (e.g., explicit conditions
for the receipt of benefits or services
based on the sex of an individual) or
statements from decisionmakers that
express discriminatory intent. In the
absence of such direct evidence, the
Department would look for
circumstantial evidence, including by
using the Arlington Heights factors or
McDonnell Douglas framework.
Proposed paragraph (b)(3) clarifies
that it is prohibited discrimination to
deny or limit coverage, deny or limit
coverage of a claim, or impose
additional cost sharing or other
limitations or restrictions on coverage to
an individual based upon the
individual’s sex at birth, gender
identity, or gender otherwise
recorded.450 The 2016 Rule provided a
445 As noted elsewhere in this preamble, although
individuals with a gender identity that differs from
their sex assigned at birth are commonly referred
to as transgender, many individuals do not identify
as such. Instead, some individuals may identify as
nonbinary or gender diverse, meaning they do not
identify with traditional binary gender or a single
gender. Within these provisions, the term
‘‘transgender’’ is being used as an umbrella term to
encompass individuals with transgender,
nonbinary, gender diverse identities.
446 Patterson, supra note 123, at p. 299.
447 Gruberg, supra note 129, at p. 21; see also
James, supra note 130, at p. 10 (2016) (25% of
respondents with insurance reported experiencing
insurance discrimination based on their gender
identity, including being denied gender specific
services and care not related to gender affirmation).
448 The definition of medical necessity can vary.
While the term ‘‘medical necessity’’ is not explicitly
defined by CMS statute or regulation, Medicare
provides coverage for items and services that are
‘‘reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the
functioning of a malformed body member.’’ 42
U.S.C. 1395y(a)(1)(A). CMS further outlines medical
necessity requirements for specific services in its
various Medicare Policy Manuals. See, e.g., Ctrs. for
Medicare & Medicaid Servs., Medicare Program
Integrity Manual, Chapter 6—Medicare Contractor
Medical Review Guidelines for Specific Services,
Sec. 6.1.4—Medical Review Process, p. 7 (2020),
https://www.cms.gov/Regulations-and-Guidance/
Guidance/Manuals/Downloads/pim83c06.pdf
(stating ‘‘[c]linical documentation that supports
medical necessity may be expected to include:
physician orders for care and treatments, medical
diagnoses, rehabilitation diagnosis (as appropriate),
past medical history, progress notes that describe
the beneficiary’s response to treatments and his/her
physical/mental status, lab and other test results,
and other documentation supporting the
beneficiary’s need for the skilled services being
provided in the SNF.’’). CMS defines ‘‘medically
necessary’’ in the Summary of Benefits and
Coverage (SBC) Template Uniform Glossary as
‘‘[h]ealth care services or supplies needed to
prevent, diagnose, or treat an illness, injury,
condition, disease, or its symptoms, including
habilitation, and that meet accepted standards of
medicine.’’ Ctrs. for Medicare & Medicaid Servs.,
Glossary of Health Coverage and Medical Terms, p.
3 (2020), https://www.cms.gov/CCIIO/Resources/
Forms-Reports-and-Other-Resources/Downloads/
Uniform-Glossary-01-2020.pdf. The American
Medical Association defines ‘‘medical necessity’’ as
‘‘[h]ealth care services or products that a prudent
physician would provide to a patient for the
purpose of preventing, diagnosing or treating an
illness, injury, disease or its symptoms in a manner
that is: (a) in accordance with generally accepted
standards of medical practice; (b) clinically
appropriate in terms of type, frequency, extent, site,
and duration; and (c) not primarily for the
economic benefit of the health plans and purchasers
or for the convenience of the patient, treating
physician, or other health care provider.’’ Am. Med.
Ass’n, Definitions of ‘‘Screening’’ and ‘‘Medical
Necessity’’ H–320.953 (2016), https://
policysearch.ama-assn.org/policyfinder/detail/H320.953?uri=%2FAMADoc%2FHOD.xml-02625.xml; see also WPATH Standards, supra note
139. While this regulation and preamble primarily
use the term ‘‘medical necessity,’’ many covered
entities also consider the related concepts of
‘‘medical appropriateness’’ or ‘‘clinical
appropriateness’’ in making decisions about care
and coverage, as can be seen in the definitions in
this footnote. For the purposes of this rule, any such
decisions must be nondiscriminatory, regardless of
the label used.
449 Bostock v. Clayton Cty., 140 S. Ct. 1731 (2020).
450 Under the general nondiscrimination
requirement in proposed § 92.207(a), a covered
entity would be barred from denying coverage of
any claim (not just for sex-specific services) on the
basis that the enrollee’s sex assigned at birth is
different than their gender identity.
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more specific prohibition, which
provided that to deny or limit coverage,
deny or limit coverage of a claim, or
impose additional cost sharing or other
limitations or restrictions on any health
service that is ordinarily or exclusively
available to persons of one sex when the
denial or limitation is due to the fact
that the individual’s sex assigned at
birth, gender identity, or gender
otherwise recorded by the covered
entity, is different from the one to which
such services are ordinarily or
exclusively available was prohibited sex
discrimination. Such discrimination is
similarly prohibited under this
provision.
Although covered health plans
routinely cover sex-specific preventive
care services (e.g., prostate and cervical
cancer screenings) for cisgender
individuals, some transgender
individuals, due to their gender identity
or because they are not enrolled in their
health plan consistent with their sex
assigned at birth, are denied coverage
parity for the same preventive health
services.451 For example, under
proposed § 92.207(b)(3), a health
insurance issuer may not deny coverage
for a transgender man who requires a
mammogram screening, based on the
fact that he is enrolled in the health plan
as a man.452 Nor could they deny him
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451 Providers
and issuers frequently formulate
incorrect assumptions about transgender and
gender non-conforming individual’s bodies when
assessing medical necessity for sex-specific
preventive care. For example, cervical cancer risks
for transgender men are sometimes erroneously
assumed by providers to be lower than for cisgender
women. Only 64% of respondents who retained a
uterus were told by their providers to get screened
for cervical cancer. See Mandi L. Pratt-Chapman &
Adam R. Ward, Provider Recommendations Are
Associated with Cancer Screening of Transgender
and Gender-Nonconforming People: A CrossSectional Urban Survey, 5 Transgender Health 80,
83 (2020), https://www.liebertpub.com/doi/10.1089/
trgh.2019.0083.
452 See also FAQs about Affordable Care Act
Implementation (Part XXVI), Q5 (May 11, 2015)
(stating ‘‘[w]hether a sex-specific recommended
preventive service that is required to be covered
without cost sharing under PHS Act section 2713
and its implementing regulations is medically
appropriate for a particular individual is
determined by the individual’s attending provider.
Where an attending provider determines that a
recommended preventive service is medically
appropriate for the individual—such as, for
example, providing a mammogram or pap smear for
a transgender man who has residual breast tissue
or an intact cervix—and the individual otherwise
satisfies the criteria in the relevant recommendation
or guideline as well as all other applicable coverage
requirements, the plan or issuer must provide
coverage for the recommended preventive service,
without cost sharing, regardless of sex assigned at
birth, gender identity, or gender of the individual
otherwise recorded by the plan or issuer’’),
available at https://www.cms.gov/cciio/resources/
fact-sheets-and-faqs/downloads/aca_
implementation_faqs26.pdf and https://
www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/
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coverage of a uterine biopsy to identify
potential uterine cancer because he is
enrolled in the health plan as a man.
Distinct from Section 1557, we remind
covered entities that section 2713 of the
Public Health Service Act (‘‘PHS Act’’)
and its implementing regulations
generally require coverage for certain
recommended preventive health
services without imposing cost-sharing
requirements.453
We clarify that Section 1557 does not
prohibit a covered entity from inquiring
about an individual’s relevant medical
history and physical traits when
necessary to determine the medical
necessity of a health service for that
individual. For example, in the same
way a medical professional would not
be prohibited from treating a pregnant
transgender man for pregnancy,454 a
health insurance issuer (including its
third party administrator activities, if
applicable) may confirm that treatment
related to pregnancy is medically
necessary for an enrollee whose
recorded sex is male.
We seek comment on this provision,
including whether it sufficiently
addresses the challenges transgender
and gender nonconforming individuals
are experiencing when seeking to access
to medically necessary care due to a
discordance between their sex assigned
at birth and their sex as recorded by
their issuer.
The Department, in paragraph (b)(4),
proposes to prohibit a covered entity
from having or implementing a
categorical coverage exclusion or
limitation for all health services related
to gender transition or other genderaffirming care.455 This is consistent with
the 2016 Rule at former § 92.207(b)(4),
modified to include gender-affirming
care. Some health plans continue to
have a categorical ban on all genderaffirming care for transgender
individuals as not medically indicated
our-activities/resource-center/faqs/aca-partxxvi.pdf.
453 45 CFR 147.130; 26 CFR 54.9815–2713; 29
CFR 2590.715–2713.
454 See discussion supra proposed § 92.206(b)(3),
(c).
455 As noted in the discussion of § 92.206 above,
this preamble uses the terms ‘‘gender transition’’
and ‘‘gender affirmation’’ interchangeably in
discussing the range of care that transgender
individuals (including those who identify using
other terms, for example, nonbinary or gender
nonconforming) may seek to treat gender dysphoria
and support gender transition or affirmation.
Because insurance coverage provisions and
medical-necessity determinations more often use
the term gender transition, within these provisions,
the term gender affirmation encompasses gender
transition, that is the terminology used in the text
of the regulation. The use of the term ‘‘gender
transition’’ in the regulation, however, is not
intended to convey a narrower meaning than the
term ‘‘gender affirmation.’’
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and as improper care to treat gender
dysphoria, regardless of whether such
care has been prescribed by a health
care professional and despite
widespread professional consensus to
the contrary.456
Such categorical exclusions in
covered plans both facially deny
transgender individuals coverage access
based on their gender identity and result
in more than de minimis harm to the
individuals; therefore they are
prohibited discrimination on the basis
of sex.457 A covered entity’s denial of
coverage solely on the basis of one’s sex
assigned at birth—i.e., if the individual
was assigned a different sex at birth,
such care coverage would not be
denied—constitutes disparate treatment
and is prohibited under this proposed
rule because transgender individuals are
the only individuals who seek
transition-related care.458 Additionally,
a recent district court opinion found
that ‘‘it is impossible to determine
whether a particular treatment is
connected to’’ gender affirming care
without comparing [the person’s] ‘‘sex
before the treatment to how it might be
impacted by the treatment.’’ 459
Nonetheless, some health plans still
have broad exclusions of coverage for
care related to gender dysphoria or
associated with gender affirmation.460
456 See Boyden v. Conlin, 341 F. Supp. 3d 979,
987 (W.D. Wis. 2018) (noting that the American
Medical Association, the American Psychiatric
Association, the American Psychological
Association, the American Counseling Association,
the American Psychoanalytic Association, and the
World Professional Association of Transgender
Health, all recognize the medical necessity of
transition related care for transgender people with
gender dysphoria); see also Flack v. Wisconsin
Dep’t of Health Servs., 395 F. Supp. 3d 1001, 1005
(W.D. Wis. 2019) (‘‘For appropriate candidates,
however, major medical organizations, including
the American Medical Association, Endocrine
Society, and American Psychiatric Association view
gender-confirming surgeries as medically accepted,
safe, and effective treatments for severe gender
dysphoria.’’).
457 See e.g., Flack, 395 F. Supp. at 1001 (striking
down Wisconsin Medicaid exclusion under Section
1557, Availability and Comparability Provisions of
the Medicaid Act, and Equal Protection Clause of
the U.S. Constitution); Cruz v. Zucker, 195 F. Supp.
3d 554, 571 (S.D.N.Y. 2016), on reconsideration,
218 F. Supp. 3d 246 (S.D.N.Y. 2016), appeal
withdrawn (Dec. 30, 2016) (finding that a
categorical ban on medically necessary treatments
for a specific diagnosis, gender dysphoria, violates
the Federal Medicaid Act’s Availability Provision).
458 See U.S. Dep’t of Justice, Brief for the United
States as Amicus Curiae in Support of PlaintiffsAppellees, Brandt v. Rutledge, No. 21–2875, 11 (8th
Cir. Aug. 23, 2021) (‘‘Only persons who are
transgender would seek these ‘‘gender transition
procedures,’’ because only their gender identity
differs from their ‘‘biological sex’’ (as defined by the
Act).’’).
459 Kadel v. Folwell, No. 1:10–cv–00272, 2022 WL
2106270, at *19 (M.D.N.C. June 10, 2022).
460 See Out2Enroll, Summary of Findings: 2021
Marketplace Plan Compliance with Section 1557, p.
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The Department proposes in
paragraph (b)(5) to ensure that a covered
entity does not impose discriminatory
limits on coverage for specific health
services related to gender transition or
other gender affirming care, which
would generally be the case if such
limits are not applied when those same
health services are not related to gender
transition. The limits that could
constitute discriminatory conduct
prohibited by this paragraph include
denying or limiting coverage, denying or
limiting a claim for coverage, imposing
additional cost sharing, or other
limitations or restrictions on coverage
on the basis of gender identity. For
example, a health plan that excludes
‘‘coverage for surgery, such as a
vaginoplasty and mammoplasty’’ for any
enrollee whose sex assigned at birth is
male ‘‘while providing coverage for
such medically necessary surgery’’ for
enrollees whose sex assigned at birth is
female ‘‘is discriminatory on its
face.’’ 461 Exclusions that limit care
related to one class of gender transition
or other gender-affirming care may also
violate this provision.462
The proposed paragraphs (b)(3)
through (5) do not: require covered
entities to cover specific procedures or
treatments for gender transition or other
gender-affirming care that they do not
otherwise cover under the plan.
In proposed paragraph (b)(6), the
Department proposes an integration
provision that prohibits covered entities
1 (2021), https://out2enroll.org/wp-content/
uploads/2020/11/Report-on-Trans-Exclusions-in2021-Marketplace-Plans.pdf (listing Bright Health,
Ala., Ariz., Ill., N.C., Neb., Okla., S.C., Tenn.;
United Healthcare, Ariz., Okla., Tenn.; Alliant, Ga.;
Mercy Care, Ill. as offering plans that include
categorical exclusions for all transition-related
care). Until 2020, the percentage of issuers that
affirmatively stated that some or all genderaffirming care for transgender individuals is
covered had increased each year. There continues
to be a presumption among some issuers, however,
that except under narrow circumstances, such care
is not medically necessary and therefore not
covered. Id.
461 Fletcher v. Alaska, 443 F. Supp. 3d 1024, 1031
(D. Alaska 2020) (Title VII); see also Kadel, No.
1:19–cv–00272, 2022 WL 2106270, at *28–*29
(Title VII).
462 See, e.g., Conn. Comm’n on Human Rights &
Opportunities, Declaratory Ruling on Petition
Regarding Health Insurers’ Categorization of Certain
Gender-Confirming Procedures as Cosmetic (Apr.
17, 2020), https://www.glad.org/wp-content/
uploads/2020/04/Dec-Rule_04152020.pdf
(discussing how depending on the policy or plan,
the categorical exclusion of certain procedures for
gender dysphoria discriminates on the basis of sex
by denying equal access to certain medical
procedures based on an individual’s assigned sex.
As such, a blanket policy exclusion for gender
transition and related services is prohibited.). See
also Challenging Insurance Exclusions for Gender
Affirming Medical Care, GLBTQ Legal Advocates &
Defenders, https://www.glad.org/cases/challenginginsurance-exclusions-for-gender-affirming-medicalcare (last updated April 23, 2020).
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from having or implementing a benefit
design that does not provide or
administer health insurance coverage or
other health-related coverage in the
most integrated setting appropriate to
the needs of qualified individuals with
disabilities.
The Department’s existing Section
504 regulation includes an integration
provision at 45 CFR 84.4(b)(2), which
would be incorporated into Section
1557 at proposed § 92.101(b)(1). Section
504’s integration provision provides that
covered entities must provide services
and programs in the most integrated
setting appropriate to the needs of the
qualified individual with a disability
(referred to as the ‘‘integration
mandate’’). The most integrated setting
appropriate to the needs of an
individual with a disability means a
setting that enables individuals with
disabilities to interact with individuals
without disabilities to the fullest extent
possible.463 In 1999, the Supreme Court
held in Olmstead v. L.C.464 that the
ADA’s integration mandate prohibits the
unjustified segregation of individuals
with disabilities. Section 504’s
integration mandate creates the same set
of obligations for entities that receive
Federal financial assistance. In addition,
health programs and activities must
make reasonable modifications to
policies, practices, or procedures when
necessary to avoid discrimination on the
basis of disability, unless the covered
entity can demonstrate that making the
modifications would fundamentally
alter the nature of the service, program,
or activity.465
Covered entities providing or
administering health insurance or other
health-related coverage are subject to
the integration requirements under
Section 504. Despite these obligations,
covered entities may not be taking these
requirements into account in their
health-related coverage benefit
design.466 For example, literature shows
that variation in benefit design,
including reimbursement rates, impact
whether individuals with disabilities
exiting hospitals enter institutional,
congregate, or otherwise segregated
settings for post-acute care services,
with payment practices and provider
463 28 CFR pt. 35, app. B (2011) (addressing
§ 35.130).
464 Olmstead v. L.C., 527 U.S. 581 (1999).
465 28 CFR 35.130(b)(7)(i); 45 CFR 92.105; see also
Olmstead, 527 U.S. at 603–07.
466 See Letter from the Bazelon Center for Mental
Health Law to Robinsue Frohboese, Acting Dir.,
Office for Civil Rights, U.S. Dep’t of Health &
Human Servs. (June 7, 2021) (discussing how
benefit design decisions can result in needless
segregation of people with disabilities). The letter
will be attached to the docket of this proposed rule
as a supplemental material at federalregister.gov.
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network design playing a greater role
than clinical characteristics in some
instances.467
OCR’s intent in articulating this
provision is to clarify that a benefit
design that results in the unjustified
segregation or institutionalization of
qualified individuals with disabilities or
that place such individuals at serious
risk of unjustified institutionalization or
segregation is prohibited disability
discrimination.
For instance, benefit designs raising
integration concerns may include those
that: limit or deny access to services in
467 Medicare Advantage and commercial health
plan benefit designs that impose beneficiary costsharing, referral requirements or prior authorization
requirements can restrict access to home health
services. See, e.g., Lacey Loomer et al., Comparing
Receipt of Prescribed Post-Acute Home Health Care
Between Medicare Advantage and Traditional
Medicare Beneficiaries: An Observational Study, 36
J. Gen. Intern. Med. 2323 (2020), https://
link.springer.com/content/pdf/10.1007/s11606-02006282-3.pdf (finding that receipt of post-acute home
health care was lower for Medicare Advantage
enrollees compared with traditional Medicare
enrollees, and that among Medicare Advantage
enrollees, HMO plans with home health utilization
restrictions (i.e., cost sharing, pre-authorization,
referral requirements) were less likely to receive
prescribed home health); Laura Skopec et al., Home
Health Use in Medicare Advantage Compared to
Use in Traditional Medicare, 39 Health Affairs 1072
(2019), https://www.healthaffairs.org/doi/10.1377/
hlthaff.2019.01091 (finding Medicare Advantage
enrollees were less likely to use home health care
than traditional Medicare enrollees were and had
shorter average home health spells, and suggesting
that these differences in use and length of spell may
be related to differences in how Medicare
Advantage plans manage and pay for home health
care); Scott E. Regenbogen et al., Spending on
Postacute Care After Hospitalization in Commercial
Insurance and Medicare Around Age Sixty-five, 38
Health Affairs 1505 (2019), https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC7795720/
pdf/nihms-1659826.pdf (finding that the benefit
design practices of commercial insurers result in
substantially less access to home health services for
post-acute care than that which is available in feefor-service Medicare). Such reductions in home
health use do not necessarily violate the integration
mandate if issuers simply reduce unnecessary
service-provision without increasing risk of
institutionalization and apply standard medical
management techniques in a nondiscriminatory
fashion as permitted under Section 1557 (proposed
§ 92.207(c)). However, a benefit design restricting
access to home health services may raise concerns
under the integration mandate if it leads to a serious
risk of unjustified or unnecessary
institutionalization of people with disabilities.
Benefit design can also reduce the risk of
institutionalization, including long-term
institutionalization. See, e.g., Amit Kumar et al.,
Comparing Post-Acute Rehabilitation Use, Length of
Stay, and Outcomes Experienced by Medicare Feefor-Service and Medicare Advantage Beneficiaries
with Hip Fracture in the United States: A Secondary
Analysis of Administrative Data, 15 PLoS Med.,
June 6, 2018, https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC6019094/pdf/pmed.1002592.pdf
(finding that benefit design and care management
practices adopted by Medicare Advantage plans
resulted in a lower risk of long-term
institutionalization within a nursing home and a
higher rate of successful discharge to the
community relative to those used in fee-for-service
Medicare).
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the most integrated setting while
making comparable services available in
segregated or institutional settings;
place additional terms and conditions
on the receipt of certain benefits in
integrated settings that are not in place
within segregated or institutional
settings; impose more restrictive rules or
requirements for coverage for services in
community-based settings than those
applied to coverage for services in
segregated or institutional settings; or
set better reimbursement rates for a
service or item for individuals in
segregated settings than for individuals
in community settings.468 For example,
an issuer covering a service or benefit
(such as personal care or durable
medical equipment) for individuals in
institutional settings, but not covering
the same service or benefit for
individuals living in their own homes or
in other community settings would
violate this provision if the difference in
coverage resulted in the unnecessary
segregation of individuals with
disabilities, or a serious risk of such
segregation, unless it could show that
modifications (to the coverage rule or
policy) would fundamentally alter the
nature of the service, program, or
activity. We note that a state Medicaid
program would generally not be
required to provide a new benefit,
because that would fundamentally alter
the nature of the program. However, to
the extent that a benefit, including an
optional benefit, is already provided as
part of the state’s program, it must be
offered in a manner that does not
incentivize institutional services over
community services.469
This provision will also be interpreted
to apply both to circumstances where
individuals with disabilities are
unnecessarily segregated or
institutionalized as a result of benefit
design features, and circumstances
where the benefit design places
individuals with disabilities at serious
risk of placement within an institution,
congregate care setting, or other
segregated settings through the coverage
of or payment for services offered or
provided in integrated settings relative
468 See Letter from the Bazelon Ctr. for Mental
Health Law, supra note 466 (discussing how benefit
design decisions can result in needless segregation
of people with disabilities). The letter will be
attached to the docket of this proposed rule as a
supplemental material at federalregister.gov.
469 See, e.g., Radaszewski ex rel Radaszewski v.
Maram, 383 F.3d 599, 611 (7th Cir. 2004)
(‘‘Although a state is not obliged to create entirely
new services or to otherwise alter the substance of
the care that it provides to Medicaid recipients . . .
the integration mandate may well require the State
to make reasonable modifications to the form of
existing services in order to adapt them to
community-integrated settings.’’)
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to segregated ones, or through funding
or service implementation practices
within a benefit design set or
administered by a covered entity that
result in such a risk.470 For example, a
Medicare Advantage plan that requires
prior authorization or step therapy to
receive a medication in the community,
but not in a skilled nursing facility,
would be in violation of this provision
if the discrepancy resulted in
unnecessary segregation or a serious risk
of unnecessary segregation and the
distinction was not clinically
appropriate. Similarly, if the plan relied
on a pharmacy benefit manager (PBM)
to administer prescription drug benefits,
and the PBM employed utilization
management techniques in the
community that created greater barriers
to accessing medication than in an
institutional setting, the PBM may be in
violation of this provision if the PBM is
subject to this part.
This provision encompasses both the
direct design of a benefit offered by a
covered entity and indirect mechanisms
that affect the implementation of a
benefit design within the covered
entity’s control, such as utilization
management practices, provider
reimbursement, contracting out to third
party-contractors such as PBMs, and
quality measurement and incentive
systems. Covered entities designing
contracts with managed care
organizations, PBMs, or other thirdparty entities taking on financial risk for
the delivery of health services should
carefully scrutinize their capitation,
reimbursement, quality measurement,
and incentive structures to ensure that
they do not result in the unjustified
segregation of individuals with
disabilities or place individuals with
disabilities at serious risk of unjustified
segregation.
OCR seeks comment on the scope and
nature of the benefit design features that
result in unjustified segregation or
institutionalization of qualified
individuals with disabilities or place
such individuals at serious risk of
unjustified institutionalization or
segregation. We are interested in
feedback on the application of the
470 U.S. Dep’t of Justice, Civil Rights Div.,
Statement of the Department of Justice on
Enforcement of the Integration Mandate of Title II
of the Americans with Disabilities Act and
Olmstead v. L.C. (June 22, 2011), https://
www.ada.gov/olmstead/q&a_olmstead.htm. See
also Fisher v. Oklahoma Health Care Authority, 355
F.3d 1175 (10th Cir. 2003) (finding that it violates
the integration mandate to restrict the number of
prescription medications available to individuals
enrolled in Medicaid home and community-based
services to five per month while not applying such
a cap to individuals in institutional settings); see
also Pashby v. Delia, 709 F.3d 307 (4th Cir. 2021).
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integration mandate to a wide variety of
health services and are particularly
interested in comments on the
application of the integration mandate
to coverage of post-acute services,
mental health services, and other
services commonly provided by nonstate payers (i.e., health insurance
issuers, self-insured group health plans,
and other payers). We are also interested
in feedback on the application of the
integration mandate to the Medicaid
program and its statutory framework at
Title XIX of the Social Security Act.
Specifically, we request input on how
state Medicaid agencies are able to
achieve compliance with the integration
mandate through benefit design, such as
through reimbursement, service scope,
and service authorization that do not
incentivize institutional services over
community services. In addition, we
request input on the amount of time
needed to reach compliance with
needed benefit design modifications.
Proposed paragraph (c) states that
nothing in this section requires the
coverage of any health service where the
covered entity has a legitimate,
nondiscriminatory reason for
determining that such health service
fails to meet applicable coverage
requirements, such as medical necessity
requirements, in an individual case.
Covered entities may employ
reasonable medical management
techniques, including medical necessity
standards,471 for determining coverage
of a particular treatment based on
whether it is medically appropriate
under current generally accepted
standards of care for an individual or
whether the treatment is experimental
or cosmetic, as long as the medical
management standards are not
discriminatory and are not otherwise
prohibited under other applicable
Federal and state law. When developed
and used appropriately in a
nondiscriminatory manner, medical
necessity guidelines prevent
unnecessary costs to covered entities
and protect the safety of enrollees by
ensuring that the requested treatment is
safe and clinically appropriate for the
particular enrollee. This determination
involves a medical review of the
patient’s condition and the clinical
appropriateness of the requested
treatment in accordance with the
covered entity’s medical necessity
guidelines. Such guidelines should be
471 See supra note 448 discussing definitions of
medical necessity. See also 45 CFR 156.125(c) (CMS
regulation prohibiting discrimination in essential
health benefits stating that ‘‘nothing in this section
shall be construed to prevent an issuer from
appropriately utilizing reasonable medical
management techniques’’).
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applied in a neutral manner and could
raise concerns under this proposed rule
if the guidelines establish more
restrictive requirements for certain
diseases or conditions without
justification, for example, if the
guidelines require a separate, more
stringent review process only for mental
health services.472
When OCR receives a complaint
alleging that a denial of coverage was
based upon prohibited discrimination
rather than on a nondiscriminatory
assessment of medical necessity,
consistent with longstanding OCR
practice, OCR will not conduct a general
review of the medical judgment behind
the denial for a specific individual.
Rather, OCR’s review will focus on the
narrow question of whether the
rationale for the denial was tainted by
impermissible discriminatory
considerations. Thus, OCR may require
a covered entity to provide its medical
necessity standards or guidelines; the
clinical, evidence-based criteria or
guidelines 473 relied upon to make the
medical necessity determination; and
the medical substantiation for the
medical necessity determination.
Claims of medical necessity that are
not based upon genuine medical
judgments will be considered evidence
of pretext for discrimination. For
example, issuers have historically
excluded services related to genderaffirming care for transgender people as
experimental or cosmetic (and therefore
not medically necessary).474
472 We note this practice may also violate the
rules regarding non-quantitative treatment
limitations applicable to group health plans and
health insurance issuers under the Paul Wellstone
and Pete Domenici Mental Health Parity and
Addiction Equity Act of 2008 (MHPAEA), Public
Law 110–343, as amended, which is distinct from
Section 1557 and not enforced by OCR. See 42
U.S.C. 300gg–26 (HHS); 29 U.S.C. 1185a
(Department of Labor); 26 U.S.C. 9812 (Department
of Treasury), and implementing regulations at 45
CFR 146.136, 29 CFR 2590.712, and 26 CFR
54.9812–1, respectively; see also U.S. Dep’t of
Labor, U.S. Dep’t of Health & Human Servs., U.S.
Dep’t of the Treasury, 2022 MHPAEA Report To
Congress: Realizing Parity, Reducing Stigma, and
Raising Awareness: Increasing Access to Mental
Health and Substance Use Disorder Coverage
(2022), https://www.dol.gov/sites/dolgov/files/
EBSA/laws-and-regulations/laws/mental-healthparity/report-to-congress-2022-realizing-parityreducing-stigma-and-raising-awareness.pdf; U.S.
Dep’t of Labor, Self-Compliance tool for the Mental
Health Parity and Addiction Equity Act (MHPAEA),
p. 38 (2020), https://www.dol.gov/sites/dolgov/files/
EBSA/laws-and-regulations/laws/mental-healthparity/self-compliance-tool.pdf.
473 See Patient Protection and Affordable Care
Act; HHS Notice of Benefit and Payment Parameters
for 2023, 87 FR 27208, 27296–300 (May 6, 2022)
(discussing newly promulgated 45 CFR 156.125(a),
which states ‘‘[a] non-discriminatory benefit design
that provides [essential health benefits] is one that
is clinically-based’’).
474 See discussion supra under this section on
paragraphs (b)(3) through (4).
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Characterizing this care as experimental
or cosmetic would be considered
evidence of pretext because this
characterization is not based on current
standards of medical care.475 Such
exclusions are a form of disparate
treatment discrimination, as they
distinguish between care that is covered
and care that is not solely by whether
such care is provided as genderaffirming care for transgender people.
Thus, categorical exclusions for genderaffirming care for transgender people
that provide the basis for the exclusion
as ‘‘experimental’’ would result in
prohibited discrimination on the basis
of sex. This is not to say that issuers
must cover all services related to
gender-affirming care for transgender
individuals—or all medically necessary
services generally. Issuers retain
flexibility in designing their benefit
packages, and this proposed rule would
not require issuers to cover any
particular benefit or to cover all
medically necessary services. It does
require, however, that issuers apply
standards in a consistent, neutral,
nondiscriminatory manner that does not
limit or deny services to individuals
based on a protected basis.
Proposed paragraph (c) also would
not prohibit a covered entity from
engaging in utilization management
techniques applied in a neutral,
nondiscriminatory manner. Utilization
management techniques include prior
authorization,476 step therapy (or ‘‘failfirst’’),477 and durational or quantity
limits.478 Utilization management
controls, designed to control costs and
ensure the clinically appropriate use of
services,479 are standard industry
475 Id.
476 Medicare defines ‘‘prior authorization’’ as ‘‘the
process through which a request for provisional
affirmation of coverage is submitted to CMS or its
contractors for review before the service is provided
to the beneficiary and before the claim is submitted
for processing.’’ 42 CFR 419.81 (Medicare definition
of prior authorization for hospital outpatient
department services). See also Ctrs. for Medicare &
Medicaid Servs., Prior Authorization Process for
Certain Hospital Outpatient Department (OPD)
Services Frequently Asked Questions (FAQs), Q1
(Dec. 27, 2021), https://www.cms.gov/files/
document/opd-frequently-asked-questions.pdf.
477 Medicare defines ‘‘step therapy’’ for the
Medicare Advantage Program as a ‘‘utilization
management policy for coverage of drugs that
begins medication for a medical condition with the
most preferred or cost effective drug therapy and
progresses to other drug therapies if medically
necessary.’’ 42 CFR 422.2.
478 Durational or quantity limits place limits on
the frequency or number of benefits to be provided,
such as limiting therapy visits to once per week or
limiting prescription drug coverage to a 30-day
supply of a medication.
479 See, e.g., Ctrs. for Medicare & Medicaid Servs.,
Prior Authorization Process for Certain Hospital
Outpatient Department (OPD) Services Frequently
Asked Questions (FAQs), Q1 (Dec. 27, 2021),
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practices 480 that are permitted under
Section 1557 as long as they are applied
in a neutral, nondiscriminatory manner
and are not otherwise prohibited under
other applicable Federal and state
law.481 Excessive use or administration
of utilization management tools that
target a particular condition that could
be considered a disability or other
prohibited basis could violate Section
1557.482 For example, prescription drug
formularies that place utilization
management controls on most or all
drugs that treat a particular condition
regardless of their costs without placing
similar utilization management controls
on most or all drugs used to treat other
conditions may be discriminatory under
this section. Similarly, benefit designs
that place utilization management
controls on most or all services that treat
a particular disease or condition but not
others may raise concerns of
discrimination. Where there is an
alleged discriminatory practice or
action, the covered entity would be
expected to provide a legitimate,
nondiscriminatory reason, based on
clinical evidence, for the practice.
Finally, the Department proposes
§ 92.207(d) to explain that the
enumeration of specific forms of
discrimination in paragraph (b) does not
limit the general applicability of the
prohibition in paragraph (a) of this
section.
Benefit Design
As discussed when addressing the
requirements of proposed paragraph (b),
OCR will apply basic nondiscrimination
https://www.cms.gov/files/document/opdfrequently-asked-questions.pdf (explaining prior
authorization ‘‘ensures that Medicare beneficiaries
continue to receive medically necessary care while
protecting the Medicare Trust Funds from
unnecessary increases in the volume of covered
services and improper payments’’ and ‘‘helps to
make sure that applicable coverage, payment, and
coding requirements are met before services are
rendered while ensuring access to and quality of
care’’).
480 See generally 42 U.S.C. 18120(1) (stating
‘‘[n]otwithstanding any other provision in the
[ACA], nothing in such Act (or an amendment made
by such Act) shall be construed to (1) prohibit (or
authorize the Secretary of Health and Human
Services to promulgate regulations that prohibit) a
group health plan or health insurance issuer from
carrying out utilization management techniques
that are commonly used as of March 23, 2010’’).
481 We note that, similar to medical necessity,
discussed previously, these practices would
generally be subject to the rules regarding nonquantitative treatment limitations applicable to
group health plans and health insurance issuers,
with respect to medical/surgical benefits and
mental health and substance use disorder benefits,
under MHPAEA, see supra note 472.
482 See generally Stacey L. Worthy et al., Now or
Never: The Urgent Need for Action Against Unfair
Coverage Denials for Quality Health Care, 48 Loy.
U. Chi. L.J. 1041 (2017), https://
lawecommons.luc.edu/luclj/vol48/iss4/8/.
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principles to the facts of the particular
plan or coverage when analyzing
allegations of discrimination under this
section to determine if the challenged
action is unlawful. Due to the factintensive nature of the analysis
necessary to determine whether a
particular benefit design is
discriminatory under this section, we
decline to include examples of per se
discriminatory benefit design features in
the proposed rule (other than categorical
exclusions of all health services related
to gender transition under proposed
paragraph (b)(4), which, as discussed
above, impermissibly single out an
entire category of services based on an
individual’s gender identity).483
However, we provide additional
discussion here to demonstrate how
OCR will approach investigations
related to allegedly discriminatory
benefit design.
Consistent with general principles in
civil rights law, covered entities will
have the opportunity to articulate a
legitimate, nondiscriminatory
justification for an alleged
discriminatory action or practice. OCR
will scrutinize the justification to ensure
it is not a pretext for discrimination.
When articulating a justification for a
challenged action or practice that relies
upon medical standards or guidelines,
covered entities should be mindful that
such standards and guidelines may be
subject to additional scrutiny if they are
not based on clinical, evidence-based
criteria or guidelines.
As discussed in detail later in this
section,484 we propose to apply this part
to all the operations of a covered entity
that is principally engaged in the
provision or administration of health
programs or activities as described in
paragraph (a) of the proposed definition
of ‘‘health program or activity,’’
483 For examples of presumptively discriminatory
benefit designs under CMS’ essential health benefits
nondiscrimination regulations applicable to nongrandfathered health insurance coverage in the
individual and small group markets, see Patient
Protection and Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for 2023, 87 FR
27208, 27301–05 (May 6, 2022) (providing the
following illustrative examples of presumptively
discriminatory practices under CMS’ essential
health benefits nondiscrimination regulations: (1)
limitation on hearing aid coverage based on age; (2)
autism spectrum disorder coverage limitations
based on age; (3) age limits for infertility treatment
coverage when treatment is clinically effective for
the age group; (4) limitation on foot care coverage
based on diagnosis (whether diabetes or another
underlying medical condition); and (5) access to
prescription drugs for chronic health conditions
(adverse tiering)). We note these regulations are
enforced by CMS and are distinct from Section 1557
and other civil rights laws enforced by OCR.
484 See discussion infra under this section on
Scope of Application and Application to Excepted
Benefits and Short-Term Limited Duration
Insurance.
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including a health insurance issuer’s
excepted benefits and short-term limited
duration insurance products. Given the
unique nature of these products, which
are generally exempt from complying
with any of the ACA’s market reforms,
we provide further analysis on how
OCR proposes to investigate potential
claims of discrimination challenging
benefit design features in these
products. OCR will consider the nature,
scope, and contours of the specific plan
at issue, and will evaluate on a case-bycase basis an alleged discriminatory
design feature in light of the entity’s
stated coverage parameters.485 Further,
as discussed throughout this section,
covered entities have the opportunity to
articulate a legitimate,
nondiscriminatory basis for their
challenged action or practice.
Scope of Application and Application to
Excepted Benefits and Short-Term
Limited Duration Insurance
Proposed § 92.207 applies to all the
operations of covered entities that
provide or administer health insurance
coverage or other health-related
coverage, including health programs
and activities that receive Federal
financial assistance, and the Department
in the administration of its healthrelated coverage programs, but would
not apply to employers generally or in
their provision of employee health
benefits per proposed § 92.2(b).
Examples of recipients that provide or
administer health insurance coverage or
other health-related coverage include
health insurance issuers, Medicare
Advantage organizations, Medicare Part
D plan sponsors, and Medicaid managed
care organizations.
Per paragraph (b) of the proposed
definition of ‘‘health program or
activity’’ under proposed § 92.4, we
propose to apply this part to all the
operations of any entity principally
engaged in the provision or
administration of health programs or
activities described in paragraph (a) of
the proposed definition of ‘‘health
program or activity,’’ including a health
insurance issuer. Thus, this proposed
rule applies to all of a covered health
insurance issuer’s health programs and
activities in the individual or group
health insurance markets, including its
offer of products through or outside of
an Exchange. For example, an issuer
485 Cf. Easley by Easley v. Snider, 36 F.3d 297,
301–05 (3d Cir. 1994) (examining the ‘‘essential
nature of the program’’ as intended by the state
when determining that a state’s Attendant Care
Program did not discriminate against individuals
with mental disabilities under the ADA by
excluding adults with disabilities who were not
mentally alert).
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participating in the Exchange and
thereby receiving Federal financial
assistance would be covered by the rule
for its qualified health plans (QHPs)
offered on the Exchange, as well as for
its health plans offered outside the
Exchange, including, for example, large
group market plans,486 grandfathered
plans,487 grandmothered plans,488
excepted benefits,489 and short-term
limited duration insurance,490 as well as
for its operations related to acting as a
third party administrator for a selfinsured group health plan.
We recognize that many of these
health insurance products are not
subject to the ACA’s market reforms
codified in title XXVII of the PHS
Act 491 in the same fashion as QHPs and
other non-grandfathered health
insurance coverage. For instance, large
group market plans and grandfathered
plans are subject to some but not all of
the market reforms,492 whereas excepted
benefits and short-term limited duration
insurance are generally exempt from all
of the ACA’s market reforms. Excepted
benefits are statutorily defined benefits
that are exempt from certain health care
requirements, such as the ACA’s market
486 42
U.S.C. 300gg–91(2); 45 CFR 144.103.
U.S.C. 18011; 45 CFR 147.140.
488 Grandmothered plans, also known as
‘‘transitional’’ plans, are certain non-grandfathered
health insurance coverage in the individual and
small group market that are not considered to be out
of compliance with certain specified market reforms
under certain conditions. See Ctrs. for Medicare &
Medicaid Servs., Extended Non-Enforcement of
Affordable Care Act-Compliance With Respect to
Certain Policies (Mar. 23, 2022), https://
www.cms.gov/files/document/extension-limitednon-enforcement-policy-through-calendar-year2023-and-later-benefit-years.pdf.
489 42 U.S.C. 300gg–91(c); 45 CFR 144.103,
§ 146.145(b), § 148.220. Excepted benefits are a triDepartment matter regulated by the Departments of
HHS, Labor, and the Treasury. In this proposed
rule, we cite to HHS regulations, but note that the
Departments of Labor and the Treasury have
parallel regulatory citations.
490 Short-term limited duration insurance is a
type of health insurance coverage that is not subject
to most of the provisions of title XXVII of the Public
Health Service Act because it is specifically
excluded from the definition of individual health
insurance coverage in the PHS Act. 42 U.S.C.
300gg–91(b)(5). Short-term limited duration
insurance is generally defined in Federal
regulations as health insurance coverage issued
under a contract that is effective for less than 12
months, and, taking into account renewals or
extensions, has a duration of no longer than 36
months in total. 45 CFR 144.103. Short-term limited
duration insurance is regulated by the Departments
of HHS, Labor, and the Treasury. In this proposed
rule, we cite to HHS regulations, but note that the
Departments of Labor and the Treasury have
parallel regulatory citations.
491 42 U.S.C. 300gg et seq.
492 For example, large group market plans and
grandfathered plans are not subject to the ACA’s
fair health insurance premiums (42 U.S.C. 300gg) or
essential health benefits (42 U.S.C. 300gg–6)
requirements.
487 42
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reforms 493 and the nondiscrimination
and portability requirements of
HIPAA 494 when certain conditions are
met, such as when benefits are
supplemental to other medical benefits,
when benefits are limited in scope, or
when the benefits are provided as
independent, non-coordinated
benefits.495 Examples of excepted
benefits include limited scope vision
insurance and limited scope dental
insurance (though stand-alone dental
plans sold through the Exchange are
subject to certain QHP requirements 496),
long term care insurance, specified
disease insurance, and Medicare
supplemental health insurance (also
known as ‘‘Medigap’’).
Public comments received from
health insurance entities on the 2015
and 2019 NPRMs opposed application
of Section 1557 nondiscrimination
requirements to excepted benefits and
short-term limited duration
insurance.497 The 2020 Rule narrowed
the scope of application to health
insurance at § 92.3(b)–(c) to provide that
an issuer principally engaged in the
business of providing health insurance
shall not, by virtue of such provision, be
covered by Section 1557 in all of its
operations. This resulted in coverage of
an issuer’s operations only with respect
to the particular line or sub-line of
business for which the issuer receives
Federal financial assistance, which
effectively exempts coverage of
excepted benefits and short-term limited
duration insurance from the
requirements established under the
2020 Rule.498
Unlike the 2020 Rule, this proposed
rule would apply to all of an issuer’s
health programs and activities when an
issuer is principally engaged in
providing or administering health
insurance coverage, or other healthrelated coverage as specified under
paragraph (b) in the proposed definition
of ‘‘health program or activity’’ under
proposed § 92.4.499 The fact that
excepted benefits and short-term limited
duration insurance are exempt from the
ACA’s market reforms because they are
not intended to serve as comprehensive
medical insurance does not negate that
offering such insurance is a ‘‘health
493 42
U.S.C. 300gg–21(b)–(c), 300gg–63.
Law 104–191, 100 Stat. 2548 (1996).
495 42 U.S.C. 300gg–91(c); 29 U.S.C. 1191b(c).
496 See, e.g., 45 CFR 155.1065, § 156.150.
497 See 81 FR 31375, 31430–31 (May 18, 2016); 85
FR 37160, 37173 (June 19, 2020).
498 See 85 FR 37173.
499 We note that some health insurance issuers
may be considered principally engaged in the
business of providing health care as defined under
the 2020 Rule at § 92.3(b), such as issuers offering
HMO plans.
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program or activity.’’ Further, the text of
Section 1557 does not limit its
protections only to health programs and
activities that are subject to other
provisions of the ACA. However,
because the Department believes
commenters’ concerns about the
application of Section 1557 to excepted
benefits and short-term limited duration
insurance warranted further
consideration, we have provided
additional discussion on how OCR
proposes to analyze allegations of
discrimination in such products in the
preceding discussion on benefit design.
Application to Third Party
Administrators
An issuer’s or other entity’s
operations related to third party
administrative services also would be
subject to the rule when the issuer
receives Federal financial assistance and
is deemed to be principally engaged in
the provision or administration of
health programs or activities as
described in paragraph (a) of the
proposed definition of ‘‘health program
or activity’’ under proposed § 92.4,
which includes providing or
administering health-related services,
health insurance coverage, or other
health-related coverage. We recognize
that the Employee Retirement Income
Security Act of 1974 (ERISA) requires
group health plans to be administered
consistent with their terms,500 and,
therefore, third party administrators are
unable to change any discriminatory
design features in the self-insured plans
they administer to comply with Section
1557’s requirements. In the 2016 Rule,
we clarified that third party
administrators were generally not
responsible for the benefit designs of the
self-insured group health plans they
administer and that enforcing Section
1557 against a third party administrator
for a group health plan with a
discriminatory benefit design could
result in holding a third party
administrator liable for plan designs
over which it had no control. Some
third party administrators, however, are
responsible for the development of the
group health plan document or other
policy documents that are ultimately
adopted by the self-insured plan. Under
these circumstances, where the
discriminatory terms of the group health
plan originated with the third party
administrator rather than with the plan
sponsor, the third party administrator
500 ERISA Section 404(a)(1)(D) (29 U.S.C.
1104(a)(1)(D)).
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could be liable for the discriminatory
design feature under Section 1557.501
When OCR receives a complaint
alleging discrimination in a self-insured
group health plan administered by a
covered entity acting as a third party
administrator, we propose to adopt an
approach similar to the 2016 Rule that
takes into account the party responsible
for the alleged discriminatory
conduct.502 We also restate the 2016
Rule’s position that we will engage in a
fact-specific analysis to evaluate
whether a third party administrator is
appropriately covered under Section
1557 as a recipient of Federal financial
assistance in circumstances where the
third party administrator is legally
separate from the issuer that receives
Federal financial assistance.
We also newly address that a third
party administrator may be liable under
this part when it is responsible for the
underlying discriminatory plan design
feature that is adopted by a group health
plan. This modification is consistent
with subsequent case law holding the
same.503 Accordingly, OCR will
determine whether responsibility for the
decision or alleged discriminatory
action lies with the plan sponsor or with
the third party administrator. Where the
alleged discrimination relates to the
administration of the plan by a covered
third party administrator, OCR will
process the complaint against the third
party administrator because it is the
entity responsible for the decision or
other action being challenged in the
complaint. For example, if a third party
administrator denies a claim because
the individual’s name suggests that they
are of a certain race or national origin,
or threatens to expose an employee’s
transgender or disability status to the
employee’s employer, OCR will proceed
against the third party administrator as
the entity responsible for the decision.
In addition, OCR will pursue claims
501 See Tovar v. Essentia Health, 342 F. Supp. 3d
947, 954 (D. Minn. 2018) (holding that a third party
administrator may be liable under Section 1557 for
damages arising from discriminatory terms in a selfinsured, employer-sponsored health plan that was
under the sole control of the employer by refusing
to construe ERISA to impair Section 1557 and
finding that ‘‘[n]othing in Section 1557, explicitly
or implicitly, suggests that [third party
administrators] are exempt from the statute’s
nondiscrimination requirements’’).
502 See 81 FR 31432.
503 See Tovar, 342 F. Supp. at 954 (holding that
a third party administrator may be liable under
Section 1557 for damages arising from
discriminatory terms in a self-insured, employersponsored health plan that was under the sole
control of the employer by refusing to construe
ERISA to impair Section 1557 and finding that
‘‘[n]othing in Section 1557, explicitly or implicitly,
suggests that [third party administrators] are exempt
from the statute’s nondiscrimination
requirements’’).
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against the third party administrator in
circumstances where the third party
administrator is the entity responsible
for developing the discriminatory
benefit design feature that was adopted
by the employer. On the other hand,
where the alleged discrimination relates
to the benefit design of a self-insured
group health plan that did not originate
with the third party administrator, but
rather with the plan sponsor, OCR will
refer the complaint to the EEOC or the
DOJ for potential investigation.
As part of OCR’s enforcement
authority, OCR has the option of
referring or transferring matters to other
Federal agencies with jurisdiction over
the entity. For example, OCR will
transfer matters to the EEOC where OCR
lacks jurisdiction over an employer
responsible for the benefit design of an
employer-sponsored group health
plan.504 Complaints alleging
discrimination in the Federal
Employees Health Benefits (FEHB)
Program, the Federal Employees Dental
and Vision Insurance Program
(FEDVIP), or the Federal Long Term
Care Insurance Program (FLTCIP),
would be referred to OPM. This Rule
does not determine how or whether any
other agency will investigate or enforce
any matter referred or transferred by the
Department.
Network Adequacy
Plan choices regarding provider
networks may also violate Section 1557.
Network plans offer medical care
through a defined set of providers under
contract with the issuer.505 Subject to
other applicable Federal and State laws,
covered entities have discretion in
developing their networks of providers,
establishing reimbursement rates, and
determining cost-sharing for in-network
and out-of-network providers, including
excluding coverage for out-of-network
care. Covered entities using provider
networks may be subject to certain
network adequacy requirements
governed by state and Federal law.506
For example, CMS regulations contain
network adequacy requirements for
504 See
28 CFR 42.605.
U.S.C. 300gg–91(10); 45 CFR 144.103
(defining ‘‘network plan’’ as ‘‘health insurance
coverage of a health insurance issuer under which
the financing and delivery of medical care
(including items and services paid for as medical
care) are provided, in whole or in part, through a
defined set of providers under contract with the
issuer’’).
506 Network adequacy refers to ‘‘a health plan’s
ability to deliver the benefits promised by providing
reasonable access to enough in-network primary
care and specialty physicians, and all health care
services included under the terms of the contract.’’
Network Adequacy, Nat’l Ass’n of Ins. Comm’rs,
https://content.naic.org/cipr_topics/topic_network_
adequacy.htm (last updated Aug. 25, 2021).
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QHPs 507 (including essential
community providers),508 Medicare
Advantage plans,509 Medicare Part D
prescription drug plans,510 and
Medicaid managed care plans.511
Several of these regulations prescribe
specific requirements, such as listing
the types of providers that must be
included in the network 512 and
establishing time and distance standards
for providers within a certain area.513
QHPs that maintain a provider network
must ensure that the provider network
consisting of in-network providers
includes essential community providers
and is ‘‘sufficient in number and types
of providers, including providers that
specialize in mental health and
substance abuse services, to ensure that
all services will be accessible without
unreasonable delay.’’ 514 Starting in plan
years 2023 and 2024 respectively, QHP
issuers on a Federally-facilitated
Exchange must meet time and distance
standards, and appointment wait time
standards established by the Federallyfacilitated Exchange.515
Recognizing that network adequacy is
regulated by other departmental
regulations, we noted in the 2016 Rule,
and again note here, that it is outside
the scope of Section 1557 to establish
uniform or minimum network adequacy
standards. Nonetheless, the prevalence
of narrow networks continues to grow as
payers seek to keep premiums and costs
low and drive patients to high-value
507 45 CFR 156.230; see also Patient Protection
and Affordable Care Act; HHS Notice of Benefit and
Payment Parameters for 2023, 87 FR 27208, 27322–
34 (May 6, 2022) (discussing changes to network
adequacy requirements for qualified health plans at
45 CFR 156.230); U.S. Dep’t of Health & Human
Servs., Ctrs. for Medicare & Medicaid Servs., 2023
Letter to Issuers in the Federally-facilitated
Exchanges, pp. 10–17 (April 28, 2022), https://
www.cms.gov/CCIIO/Resources/Regulations-andGuidance/Downloads/Final-2023-Letter-toIssuers.pdf.
508 45 CFR 156.235; see also 87 FR 27334–37
(discussing changes to the essential community
providers requirements for qualified health plans at
45 CFR 156.235).
509 See e.g., 42 CFR 422.116; U.S. Dep’t of Health
& Human Servs., Ctrs. for Medicare & Medicaid
Servs., Medicare Advantage and Section 1876 Cost
Plan Network Adequacy Guidance (2020), https://
www.cms.gov/files/document/
medicareadvantageandsection
1876costplannetworkadequacyguidance6-172020.pdf.
510 42 CFR 423.120(a).
511 42 CFR 438.68 (requiring states to establish
specified network adequacy requirements).
512 42 CFR 422.116(b) (Medicare Advantage);
§ 438.68(b) (Medicaid).
513 42 CFR 422.116(d) (Medicare Advantage);
§ 423.120 (a) (Part D); § 438.68(c) (Medicaid).
514 45 CFR 156.230(a)(1)–(2).
515 87 FR 27322–34 (discussing changes to
network adequacy requirements for qualified health
plans at 45 CFR 156.230).
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providers.516 Provider networks that
limit or deny access to care for
individuals with certain disabilities,
such as by excluding certain providers
from the network that treat high-cost
enrollees, raise discrimination
concerns.517 Similarly, limited provider
networks may require transgender
enrollees to visit inexperienced
providers in order to receive services,
regardless of the potentially serious
risks from receiving inadequate care.
Enrollees are often required to prove
why an in-network provider cannot
meet their needs before their insurance
will cover an out-of-network provider,
raising additional obstacles that may
cause particular harm to individuals
with disabilities, transgender people, or
other groups.518
We understand that an array of factors
can affect the provider network design
of a plan, including the geographic
location of the service area, the number
of available providers and specialists in
the service area, reimbursement rates,
the number of providers willing to
contract with the payer, and the overall
design of the plan as it relates to
premiums. We recognize plans’ and
issuers’ autonomy in developing their
provider networks as part of their
benefit design packages, consistent with
existing state and Federal network
adequacy and other laws, and we do not
516 Steven Findlay, In Search Of Insurance
Savings, Consumers Can Get Unwittingly Wedged
Into Narrow-Network Plans, Kaiser Health News
(Nov. 1, 2018), https://khn.org/news/in-search-ofinsurance-savings-consumers-can-get-unwittinglywedged-into-narrow-network-plans/ (discussing
73% of plans offered through the Exchange in 2018
had restrictive networks compared to 54% in 2015).
517 See Valarie K. Blake, Restoring Civil Rights to
the Disabled in Health Insurance, 95 Neb. L. Rev.
1071, 1086 (2016), https://digitalcommons.unl.edu/
cgi/viewcontent.cgi?article=3046&context=nlr; see
also, Mark Shepard, Nat’l Bureau of Econ. Research,
Working Paper 22600: Hospital Network
Competition & Adverse Selection: Evidence from
the Massachusetts Health Insurance Exchange
(2016), https://www.nber.org/papers/w22600
(finding high-cost enrollees favor plans that include
expensive ‘‘star’’ hospitals in their network, which
incentivizes plans not to include such hospitals in
their networks); Subodh Potla et al., Access to
Neurosurgery in the Era of Narrowing Insurance
Networks: Statewide Analysis of Patient Protection
and Affordable Care Act Marketplace Plans in
Arizona, 149 World Neurosurgery e963 (May 2021),
https://pubmed.ncbi.nlm.nih.gov/33515792/
(finding 67 percent of counties in Arizona do not
have access to outpatient neurosurgical care despite
the presence of neurosurgical facilities in most
counties); Stephen M. Schleicher et al., Effects of
Narrow Networks on Access to High-Quality Cancer
Care, 2 JAMA Oncology 427 (2016), https://
jamanetwork.com/journals/jamaoncology/articleabstract/2499779 (finding more than half of
Exchange plans excluded four of eleven cancer
centers).
518 Health Insurance—Choosing a Plan,
Transgender Legal Defense & Education Fund,
Trans Health Project, https://transhealthproject.org/
trans-health-insurance-tutorial/choosing-plan/ (last
updated July 16, 2020).
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propose to prescribe specific network
adequacy requirements for covered
entities under this rule. However, to
ensure compliance with Section 1557,
payers must develop their networks in
a manner that does not discriminate
against enrollees on the basis of race,
color, national origin, sex, age, or
disability.
We generally seek comment on how
Section 1557 might apply to: provider
networks; how provider networks are
developed, including factors that are
considered in the creation of the
network and steps taken to ensure that
an adequate number of providers and
facilities that treat a variety of health
conditions are included in the network;
the ways in which provider networks
limit or deny access to care for
individuals on the basis of race, color,
national origin, sex, age, or disability;
and the extent to which the lack of
availability of accessible medical
diagnostic equipment in a provider
network limits or denies access to care
for individuals with disabilities.
In addition, the Department is also
aware of growing concerns regarding
impermissible discrimination in the
application of value assessment
methodologies used to set valuations for
health care goods and services. Value
assessment methodologies are an
important tool to support health care
payers in their coverage decisions and
can significantly influence health
benefit design, particularly through
their use in price negotiations and
value-based purchasing arrangements,
as well as by informing utilization
management decisions. However, where
value assessment makes use of methods
for calculating value that penalize
individuals or groups of individuals on
the basis of race, color, national origin,
sex, age, or disability (e.g., by placing a
lower value on life-extension for a group
of individuals based on a protected
basis or via inappropriate adjustment of
clinical end points on the basis of a
protected basis under Section 1557),
they may violate this part. To that end,
OCR seeks comment on the extent,
scope and nature of value assessment
methods that discriminate on the basis
of race, color, national origin, sex, age,
or disability. We are interested in
feedback on the civil rights implications
of value assessment across a wide
variety of contexts, including utilization
management, formulary design, price
negotiations, alternative payment
models and other relevant applications.
Finally, we seek comment on all
aspects of this section. In particular, we
seek comment on the anticipated impact
of the proposed application to excepted
benefits and short-term limited duration
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insurance plans when such products are
offered by a covered entity; how the
proposed rule’s nondiscrimination
requirements would impact the industry
that offers excepted benefits and shortterm limited duration insurance and the
consumers who rely upon those
products; the prevalence of excepted
benefits and short-term limited duration
insurance offered by covered entities
and the standard industry practices
under which such plans are designed
and administered; and excepted benefits
and short-term limited duration
insurance plans’ scope of coverage,
types of exclusions and limitations,
underwriting practices, premium
setting, and actuarial or business
justifications for industry practices (as
applicable), that may raise concerns
about discrimination under Section
1557.
Prohibition on Sex Discrimination
Related to Marital, Parental, or Family
Status (§ 92.208)
The Department proposes in § 92.208
to provide that covered entities are
prohibited from discriminating on the
basis of sex in their health programs and
activities with respect to an individual’s
marital, parental, or family status. The
2016 and 2020 Final Rules did not
include a similar provision. This is not
a new concept, however, as it is similar
to the Department’s Title IX
regulation.519
The Department is proposing this
provision to address issues OCR has
encountered in its Section 1557
enforcement work. For example, OCR
has resolved complaints against covered
entities with policies of automatically
assigning a male spouse as the guarantor
when a female spouse received medical
services, while not automatically
assigning a female spouse as the
guarantor when a male spouse received
medical services.520
Proposed § 92.208 thus would provide
that, in determining whether an
individual satisfies any policy or
criterion regarding access to its health
programs or activities, a covered entity
must not take an individual’s sex into
account in applying any rule concerning
an individual’s current, perceived,
potential, or past marital, parental, or
family status.
The Department is also considering
whether § 92.208 should include a
provision to specifically address
519 45
CFR 86.40(a).
Case Summaries: Summary of Selected
OCR Compliance Activities, Dep’t of Health &
Human Servs., Office for Civil Rights, https://
www.hhs.gov/civil-rights/for-providers/complianceenforcement/examples/sex-discrimination/
index.html (last updated Feb. 21, 2017).
520 Sex
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discrimination on the basis of
pregnancy-related conditions.521
Although neither the 2016 nor the 2020
Rules included a stand-alone provision
prohibiting discrimination on the basis
of pregnancy-related conditions, the
2016 Rule defined discrimination ‘‘on
the basis of sex’’ to include, inter alia,
discrimination on the basis of
‘‘pregnancy, false pregnancy,
termination of pregnancy, or recovery
therefrom, childbirth or related medical
conditions.’’ 522 The 2020 Rule does not
include a definition of ‘‘on the basis of
sex’’ at all, and therefore does not
specifically include in the Section 1557
regulation a prohibition on
discrimination on the basis of a person’s
‘‘termination of pregnancy’’ or other
conditions related to pregnancy.
The 2020 Rule does, however,
prohibit discrimination on any of the
‘‘grounds’’ prohibited under Title IX,523
and the Department’s Title IX
regulation, in turn, includes a provision
expressly prohibiting discrimination on
the basis of pregnancy-related
conditions, including childbirth, false
pregnancy, termination of pregnancy,
and recovery therefrom.524 Under this
proposed rule, too, recipients would be
required to comply with the specific
prohibitions on discrimination found in
the Department’s Title IX regulations
(including the regulation prohibiting
discrimination on the basis of
pregnancy-related conditions, including
childbirth, false pregnancy, termination
of pregnancy, and recovery
therefrom).525 In that respect it would
not deviate from the 2016 or the 2020
Rule.
At the same time the Department
promulgated the 2020 Rule, the
Department amended its Title IX
regulations to expressly include Title
IX’s statutory abortion neutrality
provision,526 and included in the
Department’s Section 1557 regulation a
provision stating that the Section 1557
regulations may not be applied insofar
as they would ‘‘depart from, or
contradict,’’ Title IX exemptions, rights,
521 Such a provision would supplement proposed
92.101(a)(2), in which the Department proposes to
define ‘‘on the basis of sex’’ to include pregnancy
discrimination. See discussion supra § 92.101(a)(2).
522 Former 45 CFR 92.4. Although the Franciscan
Alliance court vacated the inclusion of the term
‘‘termination of pregnancy’’ in the 2016 Rule’s
definition of discrimination on the basis of sex, that
vacatur neither applies to this current rulemaking,
nor to a possible new final provision prohibiting
discrimination on the basis of pregnancy-related
conditions.
523 45 CFR 92.2(a), (b)(2).
524 45 CFR 86.40(a).
525 See proposed 45 CFR 92.101(b).
526 See 85 FR 37243 (promulgating 45 CFR
86.18(b)).
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or protections.527 This aspect of the
2020 Rule has been challenged in
litigation.528 This NPRM proposes
repealing 45 CFR 92.6(b), the provision
of the 2020 Rule challenged in those
cases. The Department’s view is that
Section 1557 does not require the
Department to incorporate the language
of Title IX’s abortion neutrality
provision 529 into its Section 1557
regulation. This approach is consistent
with the 2016 rule, which also did not
incorporate Title IX’s abortion neutrality
provision. We acknowledge that the
Franciscan Alliance court vacated the
challenged provisions of the 2016 rule
and reasoned that the Department was
required to incorporate the language of
Title IX’s abortion neutrality provision;
however, we disagree with that
decision, which does not bind this new
rulemaking.
The Department does note, however,
that there are several other statutory and
regulatory provisions related to the
provision of abortions that may apply to
an entity covered by Section 1557, and
OCR will apply such provisions
consistent with the law. For example,
the Weldon Amendment forbids funds
appropriated to HHS, among other
Departments, from being ‘‘made
available to a Federal agency or
program, or to a state or local
government, if such agency, program, or
government subjects any institutional or
individual health care entity to
discrimination on the basis that the
health care entity does not provide, pay
for, provide coverage of, or refer for
abortions.’’ 530 The Coats-Snowe
Amendment forbids discriminating
against an entity that refuses to undergo
training in performance or referrals for
abortions.531 The Church Amendment
forbids requiring any individual ‘‘to
perform or assist in the performance of
any part of a health service program
527 See
45 CFR 92.6(b)).
BAGLY v. U.S. Dep’t of Health & Human
Servs., No. 1:20–cv–11297 (D. Mass. Sept. 18, 2020);
New York v. U.S. Dep’t of Health & Human Servs.,
No. 1:2–cv–00583 (S.D.N.Y. July 20, 2020). This
NPRM proposes repealing 45 CFR 92.6(b), the
provision of the 2020 Rule challenged in those
cases.
529 20 U.S.C. 1688 (‘‘Nothing in this chapter shall
be construed to require or prohibit any person, or
public or private entity, to provide or pay for any
benefit or service, including the use of facilities,
related to an abortion. Nothing in this section shall
be construed to permit a penalty to be imposed on
any person or individual because such person or
individual is seeking or has received any benefit or
service related to a legal abortion.’’).
530 Consolidated Appropriations Act, 2022, Public
Law 117–103, div. H, title V General Provisions,
sec. 507(d)(1) (Mar. 15, 2022). See also, e.g., the
‘‘Hyde Amendment,’’ Consolidated Appropriations
Act, 2021, Public Law 116–260, div. H, §§ 506–07,
134 Stat. 1182 (Dec. 27, 2020).
531 42 U.S.C. 238n(a).
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. . . if his performance or assistance in
the performance of such part of such
program . . . would be contrary to his
religious beliefs or moral
convictions.’’ 532 It also provides that an
entity’s receipt of any grant, contract,
loan, or loan guarantee under the Public
Health Service Act, the Community
Mental Health Centers Act, or the
Developmental Disabilities Services and
Facilities Construction Act ‘‘does not
authorize any court or any public
official or other public authority to
require . . . such entity to . . . make its
facilities available for the performance
of any sterilization procedure or
abortion if the performance of such
procedure or abortion in such facilities
is prohibited by the entity on the basis
of religious beliefs or moral
convictions.’’ 533 The Church
Amendment also prohibits
discrimination against health care
personnel related to their employment
or staff privileges because they
‘‘performed or assisted in the
performance of a lawful sterilization
procedure or abortion.’’ 534 The same
nondiscrimination protections also
apply to health care personnel who
refuse to perform or assist in the
performance of sterilization procedures
or abortion.535 In addition, some of
HHS’ programs and services are
specifically governed by abortion
restrictions in the underlying statutory
authority or program authorization.536
The Department also notes in this
regard that the Emergency Medical
Treatment and Active Labor (EMTALA)
provides rights to individuals when
they seek examination or treatment and
appear at an emergency department of a
hospital that participates in
Medicare.537 If that person has an
‘‘emergency medical condition,’’ the
hospital must provide available
stabilizing treatment, including
abortion, or an appropriate transfer to
another hospital that has the capabilities
to provide available stabilizing
532 42
U.S.C. 300a–7(d).
300a–7(b)(2)(A).
534 Id. 300a–7(c)(1). For more information, see
Guidance on Nondiscrimination Protections under
the Church Amendments, U.S. Dep’t of Health &
Hum. Servs., https://www.hhs.gov/conscience/
conscience-protections/guidance-churchamendments-protections/ (last updated
Sept. 17, 2021).
535 Id.
536 See, e.g., Title X of the PHS Act, 24 U.S.C.
300a–6; Section 1303(b)(4) of the ACA, 42 U.S.C.
18023.
537 42 U.S.C. 1395dd. For more information, see
Letter to State Survey Agency Directors from U.S.
Dep’t of Health & Human Servs., Ctrs. for Medicare
& Medicaid Servs., Directors, Quality, Safety &
Oversight Group and Survey & Operations Group
(July 11, 2022), https://www.cms.gov/files/
document/qso-22-22-hospitals.pdf.
533 Id.
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treatment, notwithstanding any directly
conflicting state laws or mandate that
might otherwise prohibit or prevent
such treatment.
The Department believes it could be
beneficial to include a provision
specifically prohibiting discrimination
on the basis of pregnancy-related
conditions as a form of sex-based
discrimination. We seek comment on
whether and how the Department
should do so. We also seek comment on
what impact, if any, the Supreme Court
decision in Dobbs v. Jackson Women’s
Health Organization 538 has on the
implementation of Section 1557 and
these regulations. In light of the Dobbs
decision and E.O. 14076,539 the
Department also seeks comments on
other approaches to ensure
nondiscriminatory access to care under
this provision.
Though Congress did not require the
Department to incorporate the language
of Title IX abortion-neutrality provision
in its Section 1557 regulations, we seek
comment on this approach and on other
possible readings of the Title IX
abortion-neutrality provision, as well as
whether the Department should align its
Title IX regulation regarding the
abortion neutrality provision of Title IX
with the 2000 ‘‘Common Rule’’ version
of that regulatory provision that more
than 20 agencies have long adopted.540
Nondiscrimination on the Basis of
Association (§ 92.209)
Proposed § 92.209 prohibits
discrimination against an individual on
the basis of the race, color, national
origin, sex, age, or disability of an
individual with whom the individual is
538 142
S. Ct. 2228 (2022).
FR 42053 (July 8, 2022).
540 See 65 FR 52869 (Aug. 30, 2000); see also, e.g.,
28 CFR 54.235(d)(1) (DOJ regulation). The agencies
that have adopted the Common Rule include:
Agency for International Development, 22 CFR pt.
229; Corporation for National and Community
Service, 45 CFR pt. 2555; Department of
Agriculture, 7 CFR pt. 15d.; Department of
Commerce, 15 CFR pt. 8a; Department of Defense,
32 CFR pt. 196; Department of Energy, 10 CFR 1040;
Department of Homeland Security, 6 CFR pt. 17;
Department of Housing and Urban Development, 24
CFR pt. 3; Department of the Interior, 43 CFR pt.
41; Department of Justice, 28 CFR pt. 54;
Department of Labor, 29 CFR pt. 36; Department of
State, 22 CFR pt. 146; Department of
Transportation, 49 CFR pt. 25; Department of the
Treasury, 31 CFR pt. 28; Department of Veterans
Affairs, 38 CFR pt. 23; Environmental Protection
Agency, 40 CFR pt. 5; Federal Emergency
Management Agency, 44 CFR pt. 19; General
Services Administration, 41 CFR pt. 101–4;
National Aeronautics and Space Administration, 14
CFR pt. 1253; National Archives and Records
Administration, 36 CFR pt. 1211; National Science
Foundation, 45 CFR pt. 618; Nuclear Regulatory
Commission, 10 CFR pt. 5; Small Business
Administration, 13 CFR pt. 113; and Tennessee
Valley Authority, 18 CFR pt. 1317.
539 87
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known to have a relationship or
association. Longstanding
interpretations of existing civil rights
laws recognize claims of associational
discrimination, where the basis is a
characteristic of the harmed individual
or an individual who is associated with
the harmed individual.541 In addition,
the proposed prohibition on
associational discrimination under
Section 1557 corresponds with the
specific prohibition of discrimination
based on association with an individual
with a disability under Section 504.542
The proposed provision is consistent
with the former § 92.209 in the 2016
Rule, which was repealed by the 2020
Rule. OCR received many comments in
541 See Kengerski v. Harper, No. 20–1307, 2021
WL 3199225 (3d Cir. 2021) (a white plaintiff
employee’s claim is justiciable under an
associational discrimination legal theory under
Title VII of the Civil Rights Act of 1964, where his
employer retaliated against him for complaining
about a supervisor’s racist remarks directed at the
employee’s biracial family member and other
minority coworkers); Kelleher v. Fred A. Cook, Inc.,
939 F.3d 465 (2d Cir. 2019) (an employer’s reaction
to a non-disabled employee’s reasonable
accommodation request to care for disabled
dependent can support an inference of associational
discrimination); McGinest v. GTE Serv. Corp., 360
F.3d 1103, 1118 (9th Cir. 2004) (case involving
indirect comments in the workplace that crossed
racial lines, noting that ‘‘Title VII has . . . been held
to protect against adverse employment actions
taken because of the employee’s close association
with black friends or coworkers’’) (internal citations
omitted); Johnson v. Univ. of Cincinnati, 215 F.3d
561, 574 (6th Cir. 2001) (a plaintiff who is not a
member of a recognized protected class
nevertheless alleges a cognizable discrimination
claim under Title VII and 42 U.S.C. 1981 if he
alleges that he was discriminated against based on
his association with a member of a recognized
protected class); Tetro v. Elliot Popham Pontiac,
Oldsmobile, Buick & GMC Trucks Inc., 173 F.3d
988, 994–95 (6th Cir. 1999) (holding that white
plaintiff with biracial child stated a claim under
Title VII based on his own race ‘‘even though the
root animus for the discrimination is a prejudice
against the biracial child’’); Parr v. Woodmen of the
World Life Ins., 791 F.2d 888, 892 (11th Cir. 1986)
(‘‘Where a plaintiff claims discrimination based
upon an interracial marriage or association, he
alleges by definition that he has been discriminated
against because of his race.’’); Arceneaux v.
Vanderbilt Univ., 25 Fed. App’x. 345 (6th Cir. 2001)
(unpub’d) (treating sex discrimination as
associational discrimination). Cf. Loving v. Va., 388
U.S. 1 (1967).
542 29 U.S.C. 794a(a)(2); see also McCullum v.
Orlando Reg’l Healthcare Sys., Inc., 768 F.3d 1135,
1142 (11th Cir. 2014) (‘‘[i]t is widely accepted that
under both the [Rehabilitation Act] and the ADA,
non-disabled individuals have standing to bring
claims when they are injured because of their
association with a disabled person.’’); Loeffler v.
Staten Island Univ. Hosp., 582 F.3d 268, 279 (2d
Cir. 2009) (permitting associational discrimination
claim under Section 504). See also, 42 U.S.C.
12182(b)(1)(E) (ADA); Falls v. Prince George’s Hosp.
Ctr., No. 97–1545, 1999 WL 33485550 (D. Md. Mar.
16, 1999) (holding that parent had an associational
discrimination claim under Title III of the ADA
because hospital directly discriminated against
parent by requiring hearing parent to act as
interpreter for child who was deaf). See generally
U.S. Equal Emp’t Opportunity Comm’n, Association
Q&A, supra note 396.
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response to the 2015 and 2019 NPRMs
favoring the inclusion of an explicit
provision in Section 1557 prohibiting
discrimination on the basis of
association.543 Of particular note, the
preamble to the 2020 Rule
acknowledged that commenters
opposed the repeal of former § 92.209
because: removing such protections
would cause confusion; the lack of
reference to associational discrimination
in the regulatory text is inconsistent
with existing case law; and specific
protected populations are more
susceptible to associational
discrimination.544
The Department agrees that additional
clarity is beneficial in this area, as OCR
continues to see complaints alleging
discrimination based on association. For
example, under this provision, a
medical practice may not refuse to see
a prospective female patient based, in
part, on the knowledge that the patient
has a female spouse or partner because
the refusal would be based on the sex
of the prospective patient and on the sex
of an individual with whom the patient
is known to have a relationship or
association.
Use of Clinical Algorithms in DecisionMaking (§ 92.210)
Proposed § 92.210 states that a
covered entity must not discriminate
against any individual on the basis of
race, color, national origin, sex, age, or
disability through the use of clinical
algorithms in its decision-making. This
is a new provision, and this topic has
not been addressed in previous Section
1557 rulemaking. The Department
believes it is critical to address this
issue explicitly in this rulemaking given
recent research demonstrating the
prevalence of clinical algorithms that
may result in discrimination.545 Further,
the Department became aware that
clinical algorithms in state Crisis
Standards of Care plans used during the
COVID–19 pandemic may be screening
out individuals with disabilities, as
discussed in more detail below. OCR
believes that proposed § 92.210 would
put covered entities on notice that they
cannot use discriminatory clinical
algorithms and may need to make
reasonable modifications in their use of
the algorithms, unless doing so would
cause a fundamental alteration to their
health program or activity. The intent of
proposed § 92.210 is not to prohibit or
hinder the use of clinical algorithms but
rather to make clear that discrimination
543 See 81 FR 31375, 31438–39 (May 18, 2016); 85
FR 37160, 37199 (June 19, 2020).
544 85 FR 37199.
545 See infra note 547.
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that occurs through their use is
prohibited.
While covered entities are not liable
for clinical algorithms that they did not
develop, they may be held liable under
this provision for their decisions made
in reliance on clinical algorithms.
Covered entities using clinical
algorithms in their decision-making
should consider clinical algorithms as a
tool that supplements their decisionmaking, rather than as a replacement of
their clinical judgment. By over-relying
on a clinical algorithm in their decisionmaking, such as by replacing or
substituting their own clinical judgment
with a clinical algorithm, a covered
entity may risk violating Section 1557 if
their decision rests upon or results in
discrimination.
Clinical algorithms are tools used to
guide health care decision-making and
can range in form from flowcharts and
clinical guidelines to complex computer
algorithms, decision support
interventions, and models. End-users,
such as hospitals, providers, and payers
(e.g., health insurance issuers) use these
systems to assist with decision-making
for various purposes. Clinical
algorithms are used for screening, risk
prediction, diagnosis, prognosis, clinical
decision-making, treatment planning,
health care operations, and allocation of
resources,546 all of which affect the care
that individuals receive. Recent studies
have found that health care tools using
clinical algorithms may create or
contribute to discrimination on the
bases protected by Section 1557, and as
a result of their use by covered entities
in their health care decision-making
may lead to poorer health outcomes
among members of historically
marginalized communities.547
546 U.S. Dep’t of Health & Human Servs., Agency
for Healthcare Research & Quality, Impact of
Healthcare Algorithms on Racial Disparities in
Health and Healthcare (Jan. 25, 2022), https://
effectivehealthcare.ahrq.gov/products/racialdisparities-health-healthcare/protocol; see also
Sahar Takshi, Unexpected Inequality: DisparateImpact from Artificial Intelligence in Healthcare
Decisions, 34 J. L. & Health 215, 219 (2021), https://
engagedscholarship.csuohio.edu/cgi/
viewcontent.cgi?article=1580&context=jlh;
Christina Badaracco, Avalere, AI in Healthcare: 5
Areas in Which Artificial Intelligence Is Disrupting
the Status Quo (Dec. 16, 2019), https://avalere.com/
insights/ai-in-healthcare-5-areas-in-which-artificialintelligence-is-disrupting-the-status-quo (including
preventive health and risk assessment; diagnosis,
precision medicine, drug development, and
administration and care delivery).
547 See, e.g., Darshali A. Vyas et al., Hidden in
Plain Sight—Reconsidering the Use of Race
Correction in Clinical Algorithms, 383 N. Engl. J.
Med. 874, 876–78 (Aug. 27, 2020); Ziad Obermeyer
et al., Dissecting Racial Bias in an Algorithm Used
to Manage the Health of Populations, 366 Science
447 (Oct. 2019), https://doi.org/10.4018/978-1-79987888-9.ch001; Donna M. Christensen et al., Medical
Algorithms Are Failing Communities of Color,
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Clinical algorithms commonly
include clinical and sociodemographic
variables and measures of health care
utilization.548 Race and ethnicity are
often used as explicit input variables.
Known as ‘‘race correction’’ or ‘‘race
norming,’’ this practice adjusts an
algorithm’s output on the basis of a
patient’s race or ethnicity.549 The use of
‘‘race norming’’ notably garnered public
attention when the National Football
League (NFL) pledged to end the
practice of adjusting the results of
cognitive functioning tests based on race
to determine settlement amounts for
brain injury claims of former NFL
players.550
Another example of this practice can
be found in the clinical tools that
evaluate kidney function. Many such
tools employ an estimation of
glomerular filtration rate (eGFR) that
includes race as a factor to reflect that
Black people have been associated with
higher levels of blood creatinine than
white people.551 The option for entering
race in the eGFR is limited to a binary
‘‘black/non-black’’ option. The eGFR
adjusts the score for Black patients,
making their kidneys register as 16
percent healthier than white patients’
kidneys even though Black Americans
are about four times as likely to have
kidney failure as white Americans and
make up more than 35 percent of people
on dialysis while representing only 13
percent of the U.S. population.552 This
Health Affairs Blog (Sept. 9, 2021), https://
www.healthaffairs.org/do/10.1377/
hblog20210903.976632/full/; Kristine Gloria, Aspen
Digital, Center for Inclusive Growth, Power and
Progress in Algorithmic Bias (2021), https://
www.aspeninstitute.org/wp-content/uploads/2021/
07/Power-Progress-in-Algorithmic-Bias-July2021.pdf.
548 U.S. Dep’t of Health & Human Servs., Agency
for Healthcare Research & Quality, Healthcare
Algorithms, supra note 546.
549 Vyas, supra note 547, at 876–78 (2020).
550 Will Hobson, How ‘‘Race-Norming’’ Was Built
into the NFL Concussion Settlement, Wash. Post
(Aug. 2, 2021), https://www.washingtonpost.com/
sports/2021/08/02/race-norming-nfl-concussionsettlement/ (explaining race adjustments in
cognitive test scores emanate from studies in the
1990s finding that some people of color, including
Black people, performed worse than white people
on cognitive tests).
551 See Lundy Braun et al, Racialized Algorithms
for Kidney Function: Erasing Social Experience, 286
J. Soc. Science & Med. 113548, p. 5 (2021), https://
doi.org/10.1016/j.socscimed.2020.113548
(discussing how race correction in eGFR is rooted
in the assumption that Black individuals as a group
are biologically distinct and have higher muscle
mass than other groups, which was based on
studies from the 1970s, without considering ‘‘the
complexity of national origin, socioeconomic status,
the bodily effects of racism, and other unexplored
considerations that influence kidney function’’).
552 See, e.g., Nwamaka D. Eneanya et al., RaceFree Biomarkers to Quantify Kidney Function:
Health Equity Lessons Learned From Population
Based Research, 77 Am. J. of Kidney Diseases 667
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race-based practice reduces the number
of Black people placed on transplant
lists and referred for kidney disease
management, nephrology specialists,
and dialysis planning.553
Reliance on the eGFR clinical
algorithm may lead to discrimination
against patients based on race and
ethnicity. For example, discrimination
concerns arise if a covered entity takes
action based on the algorithmic output
that results in less favorable treatment of
a Black patient as compared to white
patients with similar or healthier
kidneys because an algorithm
determined that a Black patient’s kidney
function is better than it actually is.554
Concerns with the use of race in the
estimation of GFR in the United States
led the National Kidney Foundation and
the American Society of Nephrology to
create a task force on the issue, which
ultimately recommended an approach
that does not use race.555
The practice of ‘‘race norming’’ is not
limited to eGFR, and also occurs in the
following clinical tools: cardiology (to
assess the risk of heart failure), cardiac
surgery (to assess the risk of
complications and death), obstetrics (to
determine risks associated with vaginal
birth after cesarean), urology (to assess
the risk of kidney stones and urinary
tract infections), oncology (to predict
rectal cancer survival and breast cancer
risk), endocrinology (to assess
osteoporosis and fracture risks), and
pulmonology (to measure lung
function).556 Covered entities must be
mindful when using tools that rely on
racial or ethnic variables to ensure their
reliance on such tools does not result in
(2021), https://doi.org/10.1053/j.ajkd.2020.12.001;
Lesley A. Inker et al., A New Panel-Estimated GFR,
Including b2-Microglobulin and b-Trace Protein and
Not Including Race, Developed in a Diverse
Population, 77 Am. J. of Kidney Diseases 673
(2021), https://doi.org/10.1053/j.ajkd.2020.11.005;
Salman Ahmed et al., Examining the Potential
Impact of Race Multiplier Utilization in Estimated
Glomerular Filtration Rate Calculation on AfricanAmerican Care Outcomes, 36 J. of Gen. Internal
Med. 464, 466–67 (2021), https://link.springer.com/
content/pdf/10.1007/s11606-020-06280-5.pdf.
553 See Ahmed, supra note 552, at 467.
554 See, e.g., Compl., Crowley v. Strong Mem.
Hosp. of the Univ. of Rochester, Civ. No. 21–cv–
1078 (W.D.N.Y. Oct. 1, 2021) (22-year-old biracial
individual with kidney disease brought a Title VI
and Section 1557 action against hospital for using
a medical algorithm (eGRF) to assess kidney health
that added a race-specific multiplier for a Black
person, which deemed him ineligible for a kidney
transplant).
555 See Cynthia Delgado et al., A Unifying
Approach for GFR Estimation: Recommendations of
the NKF–ASN Task Force on Reassessing the
Inclusion of Race in Diagnosing Kidney Disease, 79
Am. J. of Kidney Diseases 268, 283–284 (2022),
https://doi.org/10.1053/j.ajkd.2021.08.003
(recommending a new estimating equation for GFR
that does not incorporate race).
556 Vyas, supra note 547.
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discriminatory clinical decisions. We
encourage covered entities to use
updated tools that have removed or do
not have known biases, such as the
updated eGFR discussed above.
The Department notes that the use of
algorithms that rely upon race and
ethnicity-conscious variables may be
appropriate and justified under certain
circumstances, such as when used as a
means to identify, evaluate, and address
health disparities.557 The Department
also notes that the use of clinical
algorithms may result in discriminatory
outcomes when variables are used as a
proxy for a protected basis and may also
result from correlations between a
variable and a protected basis.558
The use of clinical algorithms may
also result in discrimination against
individuals with disabilities and older
adults. This issue surfaced in
connection with Crisis Standards of
Care and their use during the COVID–
19 pandemic.559 During the COVID–19
public health emergency, OCR received
complaints and requests for technical
assistance related to state Crisis
Standards of Care plans. OCR worked
with multiple states to address
nondiscrimination in their Crisis
Standards of Care plans and practices,
including the states of Alabama,
Arizona, North Carolina, Texas,
Tennessee, and Utah.560 Crisis
Standards of Care are formal guidelines
or policies adopted during an
emergency or crisis that effect
substantial change in usual health care
operations and the level of care it is
possible to deliver, which is made
necessary by a pervasive or catastrophic
disaster. In the effective marshaling of
scarce resources, these standards may
authorize the prioritization of scarce
resources through means not permitted
during non-crisis conditions. Crisis
Standards of Care may include clinical
algorithms in the form of flowcharts or
other assessment tools intended to assist
covered entities in prioritizing patients
for scarce resources.
557 See e.g., Michelle Tong & Samantha Artiga,
Kaiser Family Foundation, Issue Brief: Use of Race
in Clinical Diagnosis and Decision Making:
Overview and Implications (Dec. 9, 2021), https://
www.kff.org/racial-equity-and-health-policy/issuebrief/use-of-race-in-clinical-diagnosis-and-decisionmaking-overview-and-implications/.
558 See, e.g., Obermeyer, supra note 547.
559 See U.S. Dep’t of Health & Human Servs.,
Office for Civil Rights FAQs for Healthcare
Providers during the COVID–19 Public Health
Emergency: Federal Civil Rights Protections for
Individuals with Disabilities under Section 504 and
Section 1557, Q4 (Feb. 4, 2022), https://
www.hhs.gov/civil-rights/for-providers/civil-rightscovid19/disabilty-faqs/.
560 See Civil Rights and COVID–19, supra note
184.
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Use of such assessment tools for
making resource allocation decisions
that screen out or tend to screen out
individuals with disabilities from fully
and equally enjoying any health care
service, program, or activity being
offered, would violate Section 1557,
unless the criteria used in such tools
can be shown to be necessary for the
provision of the service, program or
activity being offered.561 For example,
to the extent an assessment tool
considers a person’s current health
status, including a disability, for the
purpose of determining a person’s risk
of in-hospital mortality as part of its
resource allocation decision-making,
such assessment tool might not violate
this part, as consideration of short-term
mortality risk is necessary for the
implementation of Crisis Standards of
Care. Similarly, assessment tools should
not penalize patients for diminished
long-term life-expectancy.562
Assessment tools should not include
categorical exclusions of certain types of
disabilities, such as Down syndrome,
when treatment would not be futile for
individuals with that type of disability.
As another example, Crisis Standards of
Care may rely on instruments such as
the Sequential Organ Failure
Assessment (SOFA). The SOFA score is
a scoring tool that assesses the
performance of several organ systems in
the body (neurologic, blood, liver,
kidney, and blood pressure/
hemodynamics) and assigns a score
based on the data obtained in each
category.563 The higher the SOFA score,
the higher the likely mortality, and
consequently the higher likelihood of
de-prioritization of the patient under
many Crisis Standards of Care allocation
frameworks. In addition, the SOFA
score includes algorithmic scoring
systems, such as the Glasgow Coma
Scale, to assess the likelihood of
mortality. The Glasgow Coma Scale
considers whether a person’s speech is
comprehensible and whether they obey
commands for movement. Someone
with cerebral palsy may have difficulty
speaking or moving as part of their
underlying disability, which does not
contribute to the short-term mortality
outcomes the instrument is designed to
assess. Adjustments must be made to
ensure that such a person’s pre-existing
561 See
also 42 U.S.C. 12182(b)(2)(A)(i) (ADA).
U.S. Dep’t of Health & Human Servs.,
Office for Civil Rights, supra note 559, at Q4.
563 See generally U.S. Dep’t of Health & Human
Servs., Office of the Assistant Sec’y for
Preparedness & Response, Tech. Res. Assistance
Ctr. & Info. Exchange (TRACIE), SOFA Score: What
it is and How to Use it in Triage (Dec. 21, 2020),
https://files.asprtracie.hhs.gov/documents/asprtracie-sofa-score-fact-sheet.pdf.
562 See
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condition, and the symptoms of that
condition, are not considered when
using the Glasgow Coma Scale (whether
within or outside of the SOFA) to
evaluate whether they qualify for
treatment or what priority they will
receive in accessing scarce resources.564
When using such tools, an entity may
need to make reasonable modifications
as required by proposed § 92.205 to its
use of the assessment tool in order to
avoid discrimination, unless doing so
would cause a fundamental alteration.
In addition, the Department notes the
existence of an emerging body of
research showing that the SOFA and
other prognostic scoring algorithms
used in Crisis Standards of Care
frequently overestimate Black mortality,
resulting in greater de-prioritization of
Black patients under Crisis Standards of
Care.565 The Department solicits
comments on potential remedies to this
issue and the larger topic of racial
inequities in Crisis Standards of Care.
Research suggests that overly relying
upon any clinical algorithm,
particularly without understanding the
effects of its uses, may amplify and
perpetuate racial and other biases.566
564 See U.S. Dep’t of Health & Human Servs.,
Office for Civil Rights, supra note 559, at Q4. See
also Civil Rights and COVID–19, supra note 184.
565 See, e.g., Deepshikha C. Ashana et al.,
Equitably Allocating Resources During Crises:
Racial Differences in Mortality Prediction Models,
204 a.m. J. Respir. Crit. Care Med. 178 (2021),
https://pubmed.ncbi.nlm.nih.gov/33751910/
(finding use of SOFA in Crisis Standards of Care
may lead to racial disparities in resource
allocation); Benjamin Tolchin et al., Racial
Disparities in the SOFA Score Among Patients
Hospitalized with COVID–19, 16 PLoS ONE, Sept.
2021, at p. 2, https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC8448580/ (finding non-Hispanic Black
patients but not Hispanic patients had greater odds
of an elevated SOFA score when compared to nonHispanic white patients); Shireen Roy et al., The
Potential Impact of Triage Protocols on Racial
Disparities in Clinical Outcomes Among COVIDPositive Patients in a Large Academic Healthcare
System, 16 PLoS ONE, Sept. 2021, at p. 2, https://
pubmed.ncbi.nlm.nih.gov/34529684/ (finding Black
patients had higher SOFA scores compared to
patients of other races).
566 See, e.g., Letter from the Am. Med. Ass’n to
David Meyers, Agency for Healthcare Research &
Quality, p. 6 (May 3, 2021), https://searchlf.amaassn.org/letter/
documentDownload?uri=%2Funstructured
%2Fbinary%2Fletter%2FLETTERS%2F2021-5-3Letter-to-Meyers-re-AHRQ-AI-RFI-(002).pdf (in
response to AHRQ’s March 5, 2021 Request for
Information on Use of Clinical Algorithms That
Have the Potential to Introduce Racial/Ethnic Bias
Into Healthcare Delivery) (stating that ‘‘it is vital
that all providers understand how the clinical
algorithms they rely on to provide appropriate and
equitable care in practice are developed. The need
for such understanding is particularly acute as to
how algorithms developed using artificial
intelligence are trained in order to understand the
appropriate uses for and limitations of such
algorithms. Having this understanding will help
ensure appropriate utilization of algorithms and
encourage effective oversight by regulators,
providers, and others. Over-reliance on any
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Accordingly, the Department strongly
cautions covered entities against overly
relying upon a clinical algorithm, for
example, by replacing or substituting
the individual clinical judgment of
providers with clinical algorithms.567
The individual clinical judgment of a
provider should always be based on the
specific needs and medical history of
the patient being treated.568 Covered
entities that use clinical algorithms
should consider using clinical
algorithms as a tool to augment their
decision-making but not as a
replacement of clinical judgment.
Covered entities that overly rely upon
clinical algorithms run the risk of
noncompliance with Section 1557
because such overreliance may result in
discrimination.569
algorithm, particularly without an understanding of
what its most effective uses are, can create a risk
for amplifying and perpetuating biases that are
present in the data, including any bias based in race
or ethnicity.’’).
567 See, e.g., Public Comment from the Am. Acad.
of Family Physicians to the Office of Mgmt. &
Budget, pp. 4–5 (June 23, 2021), https://
www.aafp.org/dam/AAFP/documents/advocacy/
prevention/equality/LT-OMB-EquityRFI-062321.pdf
(in response to OMB’s May 5, 2021 notice on
Methods and Leading Practices for Advancing
Equity and Support for Underserved Communities
Through Government) (stating that ‘‘AI-based
technology is meant to augment decisions made by
the user, not replace their clinical judgement or
shared decision making.’’); Elliot Crigger &
Christopher Khoury, Making Policy on Augmented
Intelligence in Health Care, 21 a.m. Med. Ass’n, J.
of Ethics 2, E188–191, Feb. 2019, at pp. 188–189,
https://journalofethics.ama-assn.org/article/
making-policy-augmented-intelligence-health-care/
2019-02 (discussing that health care AI should be
a ‘‘tool to augment professional clinical judgment,
not a technology to replace or override it,’’ and that
organizations that implement AI systems ‘‘should
vigilantly monitor [the systems] to identify and
address adverse consequences’’); see also Nat’l
Ass’n of Ins. Comm’rs, Principles on Artificial
Intelligence (AI), p. 2 (2020), https://
content.naic.org/sites/default/files/inline-files/
AI%20principles%20as%20Adopted
%20by%20the%20TF_0807.pdf (discussing that AI
actors ‘‘should implement mechanisms and
safeguards . . . to ensure all applicable laws and
regulations are followed, including ongoing (human
or otherwise) monitoring, and when appropriate,
human intervention’’).
568 See Elliot Crigger et al., Trustworthy
Augmented Intelligence in Health Care, 46 J. Med.
Sys., Jan. 2022, at p. 6, https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC8755670/
pdf/10916_2021_Article_1790.pdf (discussing that
physicians are expected to understand the
‘‘benefits, risks, indications, appropriateness, and
alternatives’’ of using AI tools and that tools should
not be used if the physician is not able to
understand enough about the tool to use it in their
practice).
569 See U.S. Dep’t of Just., Algorithms, Artificial
Intelligence, and Disability Discrimination in Hiring
(2022), https://beta.ada.gov/ai-guidance/
(discussing how algorithms and artificial
intelligence in hiring technologies may result in
unlawful discrimination against certain groups of
applicants, including people with disabilities); U.S.
Equal Emp’t Opportunity Comm’n, The Americans
with Disabilities Act and the Use of Software,
Algorithms, and Artificial Intelligence to Assess Job
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Clinical algorithmic tools are
pervasive, and a covered entity may be
unaware of any discrimination that may
result from their reliance on such a tool.
We note that individual providers are
not likely to have designed the clinical
algorithms that augment their clinical
decision-making. However, covered
entities are responsible for ensuring that
any action they take based on a clinical
algorithm does not result in
discrimination prohibited by this part,
irrespective of whether they played a
role in designing the algorithm.570 The
fact that a covered entity did not design
the algorithm or does not have
knowledge about how the tool works
does not alleviate their responsibility to
ensure that they do not take actions that
result in discrimination. In sum, this
part does not hold covered entities
liable for clinical algorithms that they
did not develop but holds entities liable
under this proposed section for the
decisions they make in reliance on such
algorithms.
We recognize that this is a complex
and evolving area that may be
challenging for covered entities to
evaluate for potential violations of
Section 1557. The Department shares a
responsibility in working with
recipients, Department components, and
Title I entities to identify and prevent
discrimination based upon the use of
clinical decision tools and technological
innovation in health care. Covered
entities should take steps to ensure that
the use of clinical algorithms does not
result in discrimination on the basis of
race, color, national origin, sex, age, or
disability in their health programs and
activities.571 For example, covered
Applicants and Employees, EEOC–NVTA–2022–2
(2022), https://www.eeoc.gov/laws/guidance/
americans-disabilities-act-and-use-softwarealgorithms-and-artificial-intelligence (discussing
how employers’ use of software that relies on
algorithmic decision-making may violate existing
requirements under Title I of the ADA).
570 See U.S. Dep’t of Just., supra note 569, at pp.
2–3 (discussing how an employer’s use of
algorithms and artificial intelligence in hiring
technologies may still lead to unlawful
discrimination even where the employer does not
mean to discriminate); U.S. Equal Emp’t
Opportunity Comm’n, Americans with Disabilities
Act and the Use of Software, supra note 569, at p.
6 (discussing how an employers’ use of software
that relies on algorithmic decision-making may
violate existing requirements under Title I of the
ADA and that an employer may still be liable under
the ADA for its use of such tools even if the tools
are designed or administered by another entity).
571 For information on promising practices to
reduce bias and discrimination in clinical
algorithms, see generally Fed. Trade Comm’n, Using
Artificial Intelligence and Algorithms (Apr. 8,
2020), https://www.ftc.gov/news-events/blogs/
business-blog/2020/04/using-artificial-intelligencealgorithms; Fed. Trade Comm’n, Aiming for Truth,
Fairness, and Equity in Your Company’s Use of AI
(Apr. 19, 2021), https://www.ftc.gov/news-events/
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entities may choose to establish written
policies and procedures governing how
information from clinical algorithms
will be used in decision-making;
monitor any potential impacts; and train
staff on the proper use of such systems
in decision-making.572
The American Medical Association
(AMA) has been active in this area and
issued a framework to guide the health
care community in evaluating,
integrating, using, and monitoring
augmented intelligence systems that
enhance capabilities of human decisionmaking with computational methods
and systems (which includes clinical
algorithm tools).573 We recognize that
blogs/business-blog/2021/04/aiming-truth-fairnessequity-your-companys-use-ai; Fed. Trade Comm’n,
Big Data: A Tool for Inclusion or Exclusion? (Jan.
2016), https://www.ftc.gov/system/files/documents/
reports/big-data-tool-inclusion-or-exclusionunderstanding-issues/160106big-data-rpt.pdf; Nat’l
Inst. of Standards & Tech., NIST Special Publ’n
1270, Towards a Standard for Identifying and
Managing Bias in Artificial Intelligence (2022),
https://nvlpubs.nist.gov/nistpubs/
SpecialPublications/NIST.SP.1270.pdf.; Gen.
Accountability Off., Artificial Intelligence: An
Accountability Framework for Federal Agencies
and Other Entities (2021), https://www.gao.gov/
assets/gao-21-519sp.pdf; U.S. Food & Drug Admin.,
Good Machine Learning Practice for Medical Device
Development: Guiding Principles (Oct. 2021),
https://www.fda.gov/medical-devices/softwaremedical-device-samd/good-machine-learningpractice-medical-device-development-guidingprinciples; U.S. Equal Emp’t Opportunity Comm’n,
Americans with Disabilities Act and the Use of
Software, supra note 569, at pp. 12–14; Takshi,
supra note 546, at 234–39; Robert Bartlett et al.,
Algorithmic Discrimination and Input
Accountability Under the Civil Rights Acts
(preprint) (2020), https://ssrn.com/
abstract=3674665; Nicol Turner Lee et al.,
Brookings Inst., Algorithmic Bias Detection and
Mitigation: Best Practices and Policies to Reduce
Consumer Harms (2019), https://
www.brookings.edu/research/algorithmic-biasdetection-and-mitigation-best-practices-andpolicies-to-reduce-consumer-harms/; Ada Lovelace
Inst., AI Now Inst. & Open Gov’t P’ship, Executive
Summary: Algorithmic Accountability for the
Public Sector, (2021), https://
www.opengovpartnership.org/wp-content/uploads/
2021/08/executive-summary-algorithmicaccountability.pdf; Ziad Obermeyer et al., Chicago
Booth, Ctr. For Applied Artificial Intelligence,
Algorithmic Bias Playbook (2021), https://
www.chicagobooth.edu/research/center-for-appliedartificial-intelligence/research/algorithmic-bias/
playbook; Mei Chen & Michel Decary, Artificial
Intelligence in Healthcare: An Essential Guide for
Health Leaders, 33 Healthcare Mgmt. F. 10, (2020),
https://pubmed.ncbi.nlm.nih.gov/31550922/;
Genevieve Smith & Ishita Rustagi, Berkeley Haas
Ctr. for Equity, Gender, & Leadership, Mitigating
Bias in Artificial Intelligence: An Equity Fluent
Leadership Playbook (2020), https://
haas.berkeley.edu/wp-content/uploads/UCB_
Playbook_R10_V2_spreads2.pdf; Trishan Panch et
al., Artificial Intelligence and Algorithmic Bias:
Implications for Health Systems, 9 J. Global Health,
Dec. 2019, https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC6875681/pdf/jogh-09-020318.pdf.
572 See, e.g., Takshi, supra note 546, at 234–35;
Nat’l Inst. of Standards & Tech., NIST Special
Publ’n 1270, supra note 571, at pp. 42–47; Gen.
Accountability Off., supra note 571.
573 See, e.g., Crigger, Trustworthy Augmented
Intelligence in Health Care, supra note 568.
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‘‘augmented intelligence systems’’ are
different in scope from clinical
algorithm tools, yet believe that the
AMA research provides helpful
guidance when covered entities are
considering the use of clinical algorithm
tools. The AMA framework suggests that
providers should understand enough
about the tools they are using in order
to evaluate, select, and implement them,
and should forgo the use of such tools
if the provider does not adequately
understand how they work.574 Providers
should also ensure that the tool
addresses a meaningful clinical goal and
works as intended, develop a clear
protocol to identify and correct for
potential bias, have the ability to
override the tool, ensure meaningful
oversight is in place for ongoing
monitoring, and ensure clear protocols
exist for enforcement and
accountability, including a clear
protocol to ensure equitable
implementation.575 When evaluating a
tool, a provider should ask whether the
tool was properly validated and
validated for the specific case and use,
whether it was tested in different
populations to identify hidden bias, and
whether it allows barriers to access to be
found and rectified, among other
things.576
Given the increasing reliance on
clinical algorithms to inform decisionmaking in the area of health care, and
the reality that the implementation of
these tools may be discriminatory under
Section 1557, the Department proposes
§ 92.210 to make explicit that covered
entities are prohibited from
discriminating through the use of
clinical algorithms on the basis of race,
color, national origin, sex, age, or
disability under Section 1557. If OCR
receives a complaint alleging
discrimination resulting from the use of
a clinical algorithm in decision-making
against a covered entity, it will conduct
a fact-specific analysis of the allegation.
OCR’s analysis will consider, among
other things, what decisions and actions
were taken by the covered entity in
reliance upon a clinical algorithm in its
decision-making, and what measures
the covered entity took to ensure that its
decisions and actions resulting from
using a clinical algorithm were not
discriminatory. OCR would, as required
by statute and this proposed rule, work
with the covered entity to achieve
voluntary compliance.577
574 Id.
at p. 6.
575 Id.
576 Id.
at pp. 7–8.
42 U.S.C. 2000d–1 (enforcement action
may not be taken until the department has
577 See
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OCR is committed to working with
partners throughout the Department and
other Executive Agencies 578 to develop
responsive technical assistance to
support covered entities in complying
with their civil rights obligations. We
seek comment on the inclusion of this
provision; whether it is appropriately
limited to clinical algorithms or should
include additional forms of automated
or augmented decision-making tools or
models, such as artificial intelligence or
machine learning; whether a provision
such as this should include more
specificity, including actions covered
entities should take to mitigate potential
discriminatory outcomes and what
those actions should be; what promising
practices could be used by covered
entities to ensure that clinical
algorithms are not discriminatory; and
what type of technical assistance or
guidance would be most helpful to
covered entities for compliance with
this section. We seek comment on what
factors would be relevant to determine
whether a covered entity is in violation
‘‘determined that compliance cannot be secured by
voluntary means’’); 18116(a) (adopting the
enforcement mechanisms provided for an available
under Title VI).
578 Many Federal agencies are taking steps to
address discrimination in clinical algorithms and
artificial intelligence. See, e.g., U.S. Dep’t of Health
& Human Servs., Agency for Healthcare Research &
Quality, 86 FR 12948 (Mar. 5, 2021) (Request for
Information on the Use of Clinical Algorithms That
Have the Potential to Introduce Racial/Ethnic Bias
Into Healthcare Delivery); .S. Dep’t of Justice, Nat’l
Inst. of Just., Predicting Recidivism: Continuing To
Improve the Bureau of Prisons’ Risk Assessment
Tool, PATTERN (Apr. 19, 2022), https://nij.ojp.gov/
topics/articles/predicting-recidivism-continuingimprove-bureau-prisons-risk-assessment-tool;
Kristen Clarke, Assistant Att’y Gen., U.S. Dep’t of
Just., Keynote Address at the Dep’t. of Com.’s Nat’l
Telecomm. & Info. Admin.’s Virtual Listening
Session (Dec. 14, 2021), https://www.justice.gov/
opa/speech/assistant-attorney-general-kristenclarke-delivers-keynote-ai-and-civil-rightsdepartment; Press Release, U.S. Equal Emp’t
Opportunity Comm’n, EEOC Launches Initiative on
Artificial Intelligence and Algorithmic Fairness
(Oct. 28, 2021), https://www.eeoc.gov/newsroom/
eeoc-launches-initiative-artificial-intelligence-andalgorithmic-fairness; Bureau of Consumer Fin.
Protection, Adverse Action Notification
Requirements in Connection with Credit Decisions
Based on Complex Algorithms (May 26, 2022),
https://www.consumerfinance.gov/compliance/
circulars/circular-2022-03-adverse-actionnotification-requirements-in-connection-withcredit-decisions-based-on-complex-algorithms/; Bd.
of Governors of the Fed. Reserve System, Bureau of
Consumer Fin. Protection, Fed. Deposit Ins. Corp.,
Nat’l Credit Union Admin., & Office of the
Comptroller of the Currency, 86 FR 16837 (Mar. 31,
2021) (Request for Information and Comment on
Financial Institutions’ Use of Artificial Intelligence,
Including Machine Learning, Identifying Unlawful
Discrimination as a Potential Risk of Using
Artificial Intelligence); Fed. Trade Comm’n, Using
Artificial Intelligence and Algorithms, supra note
571; Fed. Trade Comm’n, Aiming for Truth,
Fairness, and Equity in Your Company’s Use of AI,
supra note 571; U.S. Dep’t of Com., Nat’l Inst. of
Standards & Tech., supra note 571.
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of this provision and what possible
defenses a covered entity may have
when using a clinical algorithm in its
decision-making that results in
discrimination. We seek comment on
governance measures, such as
transparency mechanisms, reporting
requirements, and impact assessments,
that would assist in compliance with
civil rights obligations. We also seek
comment on what types of clinical
algorithms are being used in covered
health programs and activities; how
such algorithms are being used by
covered entities; whether they are more
prevalent in certain health settings;
when clinical algorithms and variables
based on protected grounds under
Section 1557 are useful (or not); and
what mechanisms are in place or should
be in place to detect, address, and
remediate possible discriminatory
effects of their usage. Finally, we seek
comment requesting resources and
recommendations on how to identify
and mitigate discrimination resulting
from the usage of clinical algorithms
and other forms of automated decisionmaking tools and models.
Nondiscrimination in the Delivery of
Health Programs and Activities
Through Telehealth Services (§ 92.211)
Proposed § 92.211 specifically
addresses nondiscrimination in the
delivery of health programs and
activities through telehealth services.
Telehealth is a means by which covered
entities provide their health programs
and activities, and this provision
clarifies the affirmative duty that
covered entities have to not
discriminate in their delivery of such
services through telehealth. This duty
includes ensuring that such services are
accessible to individuals with
disabilities and provide meaningful
program access to LEP individuals.
Specifically, proposed § 92.211 provides
that a covered entity must not, in
delivery of its health programs and
activities through telehealth services,
discriminate on the basis of race, color,
national origin, sex, age, or disability.
Telehealth has not been addressed in
previous Section 1557 rulemaking but
has become widely used as a result of
the COVID–19 pandemic.
As defined by the Health Resources
Services Administration within the
Department, telehealth means the use of
electronic information and
telecommunications technologies to
support long-distance clinical health
care, patient and professional healthrelated education, public health, and
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health administration.579 Technologies
include videoconferencing, the internet,
store-and-forward imaging, streaming
media, and terrestrial and wireless
communications.580
Since 2016, the use of telemedicine at
self-contained clinics and the use of
telehealth provided to patients at home
has grown significantly. This is
particularly true of the use of telehealth
at home due to the COVID–19
pandemic, with one recent study
showing a 63-fold increase in Medicare
telehealth utilization during the
pandemic.581 The increased availability
of telehealth has been a benefit to many,
including transgender individuals who
have been able to access genderaffirming care without geographical
constraints or fear of stigma and
discrimination.582 However, studies also
indicate disparities in access based on
race and disability. One study found
‘‘significant’’ racial disparities in
telehealth use during the COVID–19
pandemic, which the authors believe
may lead to the worsening of preexisting health disparities.583
One study in 2016 on telehealth
among Medicare beneficiaries found
that individuals with disabilities
accounted for 65 percent of telehealth
use and 66 percent of all telehealth
services. Individuals with disabilities
using telehealth increased by 37.7
percent between the years 2014 and
2016. During that same time period,
individuals with disabilities accounted
for an increase of 53.7 percent of total
telehealth services used.584 Another
more recent study looked at the broader
579 What Is Telehealth?, U.S. Dep’t of Health &
Human Servs., Health Rsch. & Servs. Admin. (last
updated Mar. 2022), https://www.hrsa.gov/ruralhealth/telehealth/what-is-telehealth.
580 What Is Telehealth? How Is It Different from
Telemedicine?, HealthIT.gov, (last updated Oct. 17,
2019), https://www.healthit.gov/faq/whattelehealth-how-telehealth-different-telemedicine.
581 Lok Wong Samson et al., U.S. Dep’t of Health
& Human Servs., Off. of the Assistant Sec’y for
Planning & Evaluation, Issue Brief: Medicare
Beneficiaries’ Use of Telehealth Services in 2020:
Trends by Beneficiary Characteristics and Location
(2021), https://aspe.hhs.gov/sites/default/files/
documents/a1d5d810fe3433e18b192be42dbf2351/
medicare-telehealth-report.pdf.
582 Ole-Petter R. Hamnvik et al., Telemedicine
and Inequities in Health Care Access: The Example
of Transgender Health, Transgender Health (preprint) (2022), https://www.liebertpub.com/doi/epdf/
10.1089/trgh.2020.0122.
583 Robert P. Pierce & James J. Stevermer,
Disparities in the Use of Telehealth at the Onset of
the COVID–19 Public Health Emergency, J. Telemed
& Telecare, Oct. 21, 2020, at p. 5, https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC7578842/
pdf/10.1177_1357633X20963893.pdf.
584 U.S. Dep’t of Health & Human Servs., Ctrs. for
Medicare & Medicaid Servs., Information on
Medicare Telehealth Report (2018), https://
www.cms.gov/About-CMS/Agency-Information/
OMH/Downloads/Information-on-MedicareTelehealth-Report.pdf.
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noninstitutionalized population and
found that 39.8 percent of individuals
with disabilities used telehealth during
the second year of the pandemic.585
While there are benefits to be gained
from telehealth for individuals with
disabilities, including lower cost of care
and transportation costs, lower exposure
to communicable diseases, and access to
specialized care including care provided
across state lines, barriers persist around
access.586 Some of these challenges
include inaccessible telehealth
platforms and other barriers to
communication with individuals who
are deaf, blind, or have cognitive
disabilities.587 For example, telehealth
platforms have been found to not have
the ability to incorporate third-party
services, including real-time captioning
and any additional video feeds that may
be required for the provision of
qualified interpreters, direct service
providers, or supportive decision
makers.588 Telehealth may also not
include considerations for usability,
compatibility with external assistive
technology, and reduction on cognitive
burden.589 Remote patient monitoring
devices used in telehealth may be
challenging for individuals with manual
dexterity or physical mobility
disabilities to use.590 Telehealth
platforms may also not be compatible
with screen reading software.591
Purportedly accessible mobile health
(mHealth) applications, such as
applications offered by healthcare
585 Carli Friedman & Laura VanPuymbrouck,
Telehealth Use by Persons with Disabilities During
the COVID–19 Pandemic, 13 Int’l J.
Telerehabilitation 2 (2021), https://doi.org/10.5195/
ijt.2021.6402.
586 Thiru M. Annaswamy et al., Telemedicine
Barriers and Challenges for Persons with
Disabilities: COVID–19 and Beyond, 13 Disability
Health J., July 9, 2020, at p. 2, https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC7346769/
pdf/main.pdf; Daniel Young & Elizabeth Edwards,
Telehealth and Disability: Challenges and
Opportunities for Care, Nat’l Health Educ. Law
Program, (May 6, 2020), https://healthlaw.org/
telehealth-and-disability-challenges-andopportunities-for-care/.
587 Annaswamy, supra note 586, at p. 2; Young,
supra note 586; Rupa S. Valdez et al., Ensuring Full
Participation of People with Disabilities in an Era
of Telehealth, 28 J. Am. Med. Inform. Ass’n 389
(Feb. 2021), https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC7717308/.
588 Valdez, supra note 587.
589 Id.; Daihua X. Yu et al., Accessibility Needs
and Challenges of a mHealth System for Patients
with Dexterity Impairments, 12 Disabil. Rehabil.
Assist. Technol. 56–64 (2015), https://doi.org/
10.3109/17483107.2015.1063171; Erin Beneteau et
al., Telehealth Experiences of Providers and
Patients Who Use Augmentative and Alternative
Communication, 29 J. Am. Med. Inform. Ass’n 481–
488 (2022), https://doi.org/10.1093/jamia/ocab273.
590 Annaswamy, supra note 586, at p. 2.
591 Id.; Young, supra note 586; Valdez, supra note
587.
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organizations to their patients, have also
been found to be inaccessible.592
Although telehealth services are a
means by which a covered entity may
provide access to a health program or
activity, and thus are clearly covered
under Section 1557 and this proposed
rule, the Department has decided to also
include a specific provision regarding
telehealth due to the increasing
prevalence of telehealth and the
numerous related accessibility
challenges. Thus, covered entities are
required to provide telehealth services
in a manner that does not discriminate
on a protected basis under Section 1557,
including through the accessibility of
telehealth platforms (proposed § 92.204)
and by providing effective
communication for individuals with
disabilities through the provision of
appropriate auxiliary aids and services
(proposed § 92.202) and language
assistance services for LEP individuals
(proposed § 92.201). Such requirements
broadly apply to all health programs
and activities provided, including those
via telehealth. Such services would
include communications about the
availability of telehealth services, the
process for scheduling telehealth
appointments, (including the process for
accessing on-demand unscheduled
telehealth calls), and the telehealth
appointment itself.
OCR seeks comment on this approach
and whether covered entities and others
would benefit from a specific provision
addressing accessibility in telehealth
services, for individuals with
disabilities and LEP individuals. We
seek comment on what such a provision
should include, and why the proposed
provisions related to ICT, effective
communication for individuals with
disabilities, and meaningful access for
LEP individuals are insufficient.
Further, we seek comment on
challenges with accessibility specific to
telehealth and recommendations for
telehealth accessibility standards that
would supplement the ICT standards
(proposed § 92.204) and effective
communication requirements (proposed
§ 92.202) of this part. We encourage
commenters to consider the range of
technology available for accessing
telehealth, including user-friendly
design, as well as security and privacy
592 Keith M. Christensen & Jill Bezyak., Rocky
Mountain ADA Center, Telehealth Use Among
Rural Individuals with Disabilities (2020), https://
rockymountainada.org/sites/default/files/2020-02/
Rural%20Telehealth%20Rapid%20
Response%20Report.pdf; Lauren R. Milne et al.,
The Accessibility of Mobile Health Sensors for Blind
Users, 2 J. Tech. Persons Disabilities 166–175
(2014), https://scholarworks.calstate.edu/
downloads/xs55mg57v#page=173.
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requirements (for example, when using
public Wi-Fi access).
Subpart D—Procedures
Enforcement Mechanisms (§ 92.301)
Proposed § 92.301 provides that the
enforcement mechanisms available for
and provided under Title VI of the Civil
Rights Act of 1964, Title IX of the
Education Amendments of 1972,
Section 504 of the Rehabilitation Act of
1973, and the Age Discrimination Act of
1975 shall apply for purposes of Section
1557 as implemented by this part. This
is consistent with the statutory text of
Section 1557, which provides that ‘‘[t]he
enforcement mechanisms provided for
and available under such title VI, title
IX, section 794, or such Age
Discrimination Act shall apply for
purposes of violations of this
subsection.’’ 593 Additionally, this
provision is consistent with the 2016
Rule at former § 92.301(a) and § 92.5(a)
of the 2020 Rule. Enforcement
mechanisms include a private right of
action, as recognized by the Supreme
Court in Cummings v. Premier Rehab
Keller, P.L.L.C..594
Notification of Views Regarding
Application of Federal Conscience and
Religious Freedom Laws (§ 92.302)
In proposed § 92.302, the Department
specifically addresses the application of
Federal conscience and religious
freedom laws. This is a newly proposed
provision, as neither the 2016 nor 2020
Rule provided a specific means for
recipients to notify the Department of
their views regarding the application of
Federal conscience or religious freedom
laws.
Proposed paragraph (a) provides that
a recipient may raise with the
Department its belief that the
application of a specific provision or
provisions of this regulation as applied
to it would violate Federal conscience
or religious freedom laws. Such laws
include but are not limited to the CoatsSnowe Amendment, Church
Amendments, RFRA, section 1553 of the
ACA, section 1303 of the ACA, and the
Weldon Amendment. Recipients are
also reminded that they can file
complaints regarding Federal
conscience laws with OCR, as provided
in 45 CFR part 88.
Proposed paragraph (b) provides that
once OCR receives a notification
pursuant to proposed paragraph (a),
OCR shall promptly consider those
views in responding to any complaints
593 42
U.S.C. 18116.
S. Ct. 1562, 1569–70 (2022) (‘‘it is ‘beyond
dispute that private individuals may sure to
enforce’ [Section 504 and Section 1557]’’).
594 142
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or otherwise determining whether to
proceed with any investigation or
enforcement activity regarding that
recipient’s compliance with the relevant
provisions of this regulation. Any
relevant ongoing investigation or
enforcement activity regarding the
recipient shall be held in abeyance until
a determination has been made under
paragraph (c). Considering recipients’
religious- or conscience-based concerns
in the context of an open case (i.e.,
when OCR first has cause to consider
the recipient’s compliance), will allow
OCR to make an informed, case-by-case
decision and, where applicable, protect
a recipient’s conscience or religious
freedom rights. Similarly, holding
ongoing investigations and enforcement
activity in abeyance is designed to
alleviate the burden of a recipient
having to respond to an investigation or
enforcement action until a recipient’s
objection has been considered by OCR.
Proposed paragraph (c) makes clear
OCR’s discretion to determine at any
time whether a recipient is wholly
exempt from or entitled to a
modification of the application of
certain provisions of this part, or
whether modified application of the
provision is required under a Federal
conscience or religious freedom law.
Proposed paragraph (c) requires that, in
determining whether a recipient is
exempt from the application of the
specific provision or provisions raised
in its notification, OCR must assess
whether there is a sufficiently concrete
factual basis for making a determination
and apply the applicable legal standards
of the referenced statute. Proposed
paragraph (c) further provides that,
upon making a determination regarding
whether a particular recipient is exempt
from—or subject to a modified
requirement under—a specific provision
of this part, OCR will communicate that
determination to the recipient.
Proposed paragraph (d) provides that
if OCR determines that a recipient is
entitled to an exemption or modification
of the application of certain provisions
of this rule based on the application of
such laws, that determination does not
otherwise limit the application as to any
other provision of this part to the
recipient.
OCR maintains an important civil
rights interest in the proper application
of Federal conscience and religious
freedom protections. In enforcing
Section 1557, OCR is thus committed to
complying with RFRA and all other
legal requirements. The Department
believes that the proposed approach in
this section will assist the Department
in fulfilling that commitment by
providing the opportunity for recipients
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to raise concerns with the Department,
such that the Department can determine
whether an exemption or modification
of the application of certain provisions
is appropriate under the corresponding
Federal conscience or religious freedom
law. As noted above, the Department
also maintains a strong interest in taking
a case-by-case approach to such
determinations, which will allow it to
account for any harm an exemption
could have on third parties595 and, in
the context of RFRA, to consider
whether the application of any
substantial burden on a person’s
exercise of religion is in furtherance of
a compelling interest and is the least
restrictive means of advancing that
compelling interest.596
The Department seeks comment on
this approach, including whether such a
provision should include additional
procedural information, the potential
burdens of such a provision on
recipients and potential third parties,
and additional factors that the
Department should take into account
when considering the relationship
between Federal conscience and
religious freedom laws and Section
1557’s civil rights protections. We also
seek comment on what alternatives, if
any, the Department should consider.
Procedures for Health Programs and
Activities Conducted by Recipients and
State Exchanges (§ 92.303)
Proposed § 92.303 provides for the
enforcement procedures related to
health programs and activities
conducted by recipients and State
Exchanges, consistent with former
§ 92.302 of the 2016 Rule. The 2020
Rule does not include this provision,
and instead relies on § 92.5, the general
Enforcement Mechanisms section
discussed above, which includes a
paragraph (b) that notes that the Director
has been delegated authority to enforce
Section 1557, including the authority to
conduct investigations and compliance
reviews, make enforcement referrals to
the DOJ, and take any other appropriate
remedial action the Director deems
necessary.
The 2020 Rule does not make
sufficiently clear for either covered
entities or individuals protected by
Section 1557 what procedures will
595 See Cutter v. Wilkinson, 544 U.S. 709, 720
(2005) (in addressing religious accommodation
requests, ‘‘courts must take adequate account of the
burdens a requested accommodation may impose
on nonbeneficiaries’’).
596 Cf. Gonzales v. O Centro Espı´rita Beneficente
Unia˜o do Vegetal, 546 U.S. 418, 439 (2006)
(‘‘[C]ourts should strike sensible balances, pursuant
to a compelling interest test that requires the
Government to address the particular practice at
issue.’’) (emphasis added).
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apply in OCR’s enforcement of Section
1557. As OCR has clear procedures that
apply under Title VI, Title IX, Section
504, and the Age Act, OCR similarly
needs to have clear procedures that
apply under Section 1557.
Proposed paragraph (a) applies the
procedural provisions in the Title VI
regulation with respect to
administrative enforcement actions
concerning discrimination on the basis
of race, color, national origin, sex, and
disability under Section 1557. Since the
effective date of the ACA, OCR has
enforced Section 1557 according to the
procedural provisions of Title VI. The
Title VI procedures have applied to
discrimination on the basis of race,
color, and national origin for decades, as
well as to discrimination on the basis of
sex and disability, as the Title VI
procedures have been incorporated into
the regulations implementing Title IX
and Section 504.597 In the Department’s
view, therefore, it is logical and
appropriate to similarly apply these
procedures in enforcement with respect
to race, color, national origin, sex, and
disability discrimination under Section
1557.
Proposed paragraph (b) applies Age
Act procedures to enforce Section 1557
with respect to age discrimination
complaints against recipients and State
Exchanges. The Age Act has its own set
of procedures, and OCR has been
applying those procedures in
enforcement with respect to age
discrimination under Section 1557 from
the effective date of the ACA to the
present.
Proposed paragraph (c) provides that
when a recipient fails to provide OCR
with requested information in a timely,
complete, and accurate manner, OCR
may, after attempting to reach a
voluntary resolution, find
noncompliance with Section 1557 and
initiate the appropriate enforcement
procedure, found at 45 CFR 80.8. This
provision was found at former
§ 92.302(c) in the 2016 Rule. The 2020
Rule repealed the provision, stating that
when a recipient fails to provide OCR
with requested information in a timely,
complete, and accurate manner, OCR
may find noncompliance with Section
1557 and initiate appropriate
enforcement procedures, absent the
need to attempt to effectuate voluntary
compliance. The preamble to the 2020
Rule stated that the existing authorities
already contain parallel provisions.598
Yet, the preamble cites a number of
provisions that do not support the
statement but rather address seeking
597 45
598 85
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resolution through voluntary means
when there is a failure to comply with
the regulation.599 We believe that the
provision we propose at paragraph (c) is
helpful in clarifying for recipients and
individuals covered by Section 1557
that, should OCR’s attempt to effectuate
voluntary compliance be unsuccessful,
the consequences of failing to provide
OCR with information necessary for
OCR to determine compliance with the
law may include the initiation of the
appropriate enforcement procedures,
found at 45 CFR 80.8.
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Procedures for Health Programs and
Activities Administered by the
Department (§ 92.304)
Proposed § 92.304 addresses
procedures for all claims of
discrimination against the Department
under Section 1557 or this part.
Proposed paragraph (b) makes the
existing procedures under the Section
504 federally conducted regulation at 45
CFR 85.61 through 85.62 applicable to
all such claims under Section 1557 for
all protected bases (i.e., race, color,
national origin, sex, age, and disability).
This is the only procedure that is
currently in place for any
discrimination claims against the
Department under the laws that OCR
enforces. Proposed paragraph (c)
requires the Department to provide OCR
access to information relevant to
determining compliance with Section
1557 or this part, and proposed
paragraph (d) prohibits the Department
from retaliating against an individual or
entity for the purpose of interfering with
any right secured by Section 1557 or
this part, or because such individual or
entity has participated in an
investigation, proceeding, or hearing
under Section 1557 or this part. This is
consistent with the 2016 Rule at former
§ 92.303.
The 2020 Rule does not include any
specific provision for the processing of
claims of race, color, national origin,
sex, age, or disability discrimination
against any covered Departmental
program, having rescinded former
§ 92.303 in its entirety. The other
599 Id. at n. 253 (discussing 45 CFR 80.7(d) (which
requires the Department to seek resolution through
informal means where there is a failure to comply
with the regulation); § 80.8(c)(1) (note: § 80.8(c)
does not include a paragraph (1), but § 80.8(c)
requires the Department to seek voluntary
compliance and take other steps prior to taking
action to terminate Federal financial assistance);
§ 84.6(b) (stating the right of a recipient to take
voluntary action to overcome the effects of
conditions that have resulted in limited
participation by qualified individuals with
disabilities); § 90.49(c) (stating that the provision of
special benefits to children or the elderly is
generally presumed to be voluntary affirmative
action)).
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statutes that OCR enforces—Title VI,
Title IX, and the Age Act—do not
directly apply to the Department. The
2016 Rule adopted the Section 504
procedure for all claims of
discrimination against any
Departmental health program under
Section 1557, a procedure that has been
in place for decades, is familiar to the
Department and has worked effectively.
We believe it is important in this rule
to identify the procedure that we will
use in enforcing Section 1557 with
respect to Departmental health programs
and activities and therefore are
proposing to do so by reinstating the
provision from the 2016 Rule at
proposed paragraph (b).
The 2020 Rule also does not include
the provision of the 2016 Rule that
required the Department to provide OCR
access to information necessary to
determine compliance with Section
1557. The reason provided was that
‘‘regulations implementing Section
1557’s four underlying statutes already
contain provisions addressing access to
review of covered entities’ records of
compliance,’’ 600 and thus the language
in the 2016 Rule to this effect was
unnecessary. However, apart from the
Section 504 regulation applicable to the
Department, none of the other
regulations apply to the Department;
therefore, provisions under those
regulations do not apply to the
Department. Consequently, the
Department is proposing to reinstate
this provision at proposed § 92.304(c).
The 2020 Rule also does not include
a prohibition on retaliation that applies
to the Department, which was provided
at former § 92.303(d). In repealing this
provision, the preamble to the 2020
Rule stated that ‘‘regulations
implementing Section 1557’s four
underlying statutes already contain
provisions against intimidation and
retaliation as appropriate . . . The
language in the 2016 Rule to this effect
was unnecessary.’’ 601 As we have
noted, regulations implementing three
of the four underlying regulations do
not apply to the Department; therefore,
we now disagree with the Department’s
reasoning in 2020.
We are including a retaliation
provision at proposed paragraph (d) to
make clear that the Department,
including Federally-facilitated
Exchanges, must not intimidate,
threaten, coerce, retaliate, or otherwise
discriminate against any individual or
entity for the purpose of interfering with
any right or privilege secured by Section
1557 or this part, or because such
600 85
FR 37203.
601 Id.
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individual or entity has made a
complaint, testified, assisted, or
participated in any manner in an
investigation, proceeding or hearing
under Section 1557 or this part. The
ADA similarly prohibits such
retaliation, interference, coercion, and
intimidation,602 and, as discussed supra
in relation to proposed § 92.3
(relationship to other laws), the ADA
and Section 504 are generally
understood to impose substantially the
same requirements. The Department is
thus prohibited from engaging in
retaliation, intimidation, coercion, or
interferences with rights under Section
504. We are proposing to similarly
prohibit the Department from such
discrimination under Section 1557.
Further, this proposed provision would
hold the Department and Federallyfacilitated Exchanges to the same
standards to which the Department
holds all recipients of Federal financial
assistance.
IV. Change in Interpretation—Medicare
Part B Meets the Definition of Federal
Financial Assistance
The Department’s longstanding
position has been that Medicare Part B
funding does not constitute Federal
financial assistance for the purpose of
Title VI, Title IX, Section 504, the Age
Act, and Section 1557.603 For the
reasons discussed below, and after
reevaluating the Department’s position
on Medicare Part B, we are proposing to
change that position and treat Medicare
Part B funds as Federal financial
assistance to the providers and
suppliers subsidized by those funds.
To constitute Federal financial
assistance, the Federal funds or
assistance must confer a benefit or
subsidy on the recipient; compensation
from the government for services
provided to the government is not
Federal financial assistance.604 Further,
Congress or the department
administering the funds must intend for
the assistance to subsidize the entity.605
Building on these principles, this rule
proposes to define ‘‘Federal financial
assistance,’’ at proposed § 92.4, in
relevant part as ‘‘any grant, loan, credit,
subsidy, contract (other than a
procurement contract but including a
contract of insurance), or any other
602 42
U.S.C. 12203.
FR 31375, 31383 (May 18, 2016).
604 See, e.g., DeVargas v. Mason & Hanger-Silas
Mason Co., Inc., 911 F.2d 1377, 1382 (9th Cir.
1990), cert. denied, 498 U.S. 1074 (1991); Jacobson
v. Delta Airlines, 742 F.2d 1202, 1209 (9th Cir.
1984); Hunter. v. D.C., 64 F. Supp. 3d 158, 172
(D.D.C. 2020).
605 U.S. Dep’t of Transport. v. Paralyzed Veterans
Ass’n, 477 U.S. 597, 606–07 (1986); Grove City Coll.
v. Bell, 465 U.S. 555, 564 (1984).
603 81
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arrangement by which the Federal
Government provides assistance or
otherwise makes assistance available in
the form of: (i) Funds; (ii) Services of
Federal personnel; or (iii) Real and
personal property or any interest in or
use of such property, including: (A)
Transfers or leases of such property for
less than fair market value or for
reduced consideration; and (B) Proceeds
from a subsequent transfer or lease of
such property if the Federal share of its
fair market value is not returned to the
Federal Government.’’ This proposed
definition is similar to the definition in
HHS’ regulations implementing the
Title VI, Title IX, Section 504, and the
Age Act, with the exception of the
phrase ‘‘otherwise makes assistance
available.’’ 606 Similar to the
Department’s definition of ‘‘recipient’’
under the implementing regulations for
Title VI, Title IX, Section 504, and the
Age Act, the Department proposes to
define ‘‘recipient’’ as ‘‘any State or its
political subdivision, or any
instrumentality of a State or its political
subdivision, any public or private
agency, institution, or organization, or
other entity, or any person, to whom
Federal financial assistance is extended
directly or indirectly, including any
subunit, successor, assignee, or
transferee of a recipient, but such term
does not include any ultimate
beneficiary.’’ 607
In the Department’s view, Medicare
Part B payments constitute Federal
financial assistance and providers
subsidized as a result of those payments
are recipients. The Department’s longheld view that Medicare Part A
constitutes Federal financial assistance
is instructive.608 Like Medicare Part A,
Medicare Part B is a Department
program that provides payment for
health services to eligible
individuals.609 Eligible individuals
choose to enroll in Medicare Part B and
pay a monthly fee for coverage; in
606 45 CFR 80.13(f) (Title VI); § 84.3(h) (Section
504); § 86.2(g) (Title IX); § 91.4 (Age Act).
607 Proposed § 92.4.
608 45 CFR pt. 80 app. A pt. I, No. 121 (Federal
Assistance to which these Regulations Apply;
Assistance other than continuing assistance to
States; Supplementary medical insurance benefits
for the aged (Title XVIII, Part A, Social Security Act,
42 U.S.C. 1395c–1395i–2)).
609 Medicare Part A also pays for hospital
coverage and care in skilled nursing facilities. Parts
of Medicare, Medicare.gov, https://
www.medicare.gov/basics/get-started-withmedicare/medicare-basics/parts-of-medicare (last
visited June 15, 2022). Medicare Part B provides
coverage for outpatient care by physicians and other
health care providers, lab tests, home health care,
durable medical equipment, and many preventive
services. Id. See also What Medicare Covers,
Medicare.gov, https://www.medicare.gov/whatmedicare-covers (last visited June 15, 2022).
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exchange, the program covers the
services provided by medical providers
and suppliers 610 for the services and
supplies they provide to these
individuals. In addition to fee payments
made by beneficiaries, Federal funds are
used to subsidize the entities that
provide Part B services. The Federal
funding benefits Part B beneficiaries by
assisting them in paying for necessary
health care services; and providers, in
turn, receive the benefit of a reliable
source of payment for the services
provided to eligible patients, at least
some of whom may have been unable to
afford services otherwise. As in Grove
City College v. Bell, discussed below,
the government is assisting providers of
services by making available to them a
segment of the patient population that
either (a) would not have been able to
afford any medical services, or (b)
would not have been able to afford these
specific providers. In these respects,
Part B is no different than Part A
because Part B is financial assistance to
providers that subsidizes their provision
of health care to Part B beneficiaries.
Further, providers are recipients of
these funds because they are entities
that operate health programs and
activities to whom Federal financial
assistance is provided.
Despite these clear similarities, the
Department has previously considered
Medicare Part A to constitute Federal
financial assistance, while analyzing
Part B differently. When the
Department’s Title VI regulation was
first published, the Department
included an Appendix, titled Federal
Assistance to Which These Regulation
Apply.611 Although the Appendix is to
the Department’s Title VI regulation, the
Department and courts have relied on it
in determining whether Department
funds are Federal financial assistance in
claims under Title IX, Section 504, and
the Age Act, as well.612 The Appendix
contains two lists: ‘‘Assistance Other
than Continuing Assistance to States,’’
and ‘‘Continuing Assistance to States.’’
In the former list, the Department
included Medicare Part A, but not
Medicare Part B.613 The omission
reflected the Department’s position that
610 We use the term ‘‘providers’’ to refer to
physician’s offices and other entities that provide
Part B services, consistent with the use of the term
‘‘provider’’ elsewhere in this rule. We acknowledge
that this term has a different meaning in the
Medicare program.
611 45 CFR pt. 80 app. A, pt. I, No. 121.
612 See, e.g., Chowdury v. Reading Hosp. & Med.
Ctr., 677 F.2d 317, 318–19 (3d Cir. 1982), cert.
denied, 463 U.S. 1229 (1983) (Title VI); Doe v.
League Sch. of Greater Boston, Inc., No. 16–cv–
1194, 2017 WL 3594257, at *4 (D. Mass. Aug. 21,
2017) (Title IX).
613 45 CFR pt. 80 app. A., pt. I, No. 121.
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Medicare Part B did not constitute
Federal financial assistance.614 Many
courts have held that Medicare Part A
is Federal financial assistance for the
purpose of coverage under the Spending
Clause civil rights statutes.615
In explaining its position that
Medicare Part B was not Federal
financial assistance in proposing the
regulations implementing Section 504,
the Department relied on the fact that
Medicare Part B is ‘‘provided by way of
a contract,’’ and thus is a contract of
614 See 81 FR 31375, 31383 (May 18, 2016)
(proposing that, ‘‘consistent with OCR’s
enforcement of other civil rights authorities, the
definition of Federal financial assistance does not
include Medicare Part B’’ under Section 1557). The
Department provided the following explanation in
its Section 504 final rule: ‘‘In its May 1976 Notice
of Intent, the Department suggested that the
arrangement under which individual practitioners,
hospitals, and other facilities receive
reimbursement for providing services to
beneficiaries under Part B of title XVIII of the Social
Security Act (Medicare) constitutes a contract of
insurance or guaranty and thus falls within the
exemption from the regulation. This explanation
oversimplified the Department’s view of whether
Medicare Part B constitutes Federal financial
assistance. The Department’s position has
consistently been that, whether or not Medicare
Part B arrangements involve a contract of insurance
or guaranty, no Federal financial assistance flows
from the Department to the doctor or other
practitioner under the program, since Medicare Part
B—like other social security programs—is basically
a program of payments to direct beneficiaries.’’ 45
CFR pt. 84 app. A (Analysis of Final Regulation);
42 FR 22676, 22685 (May 4, 1977).
615 See, e.g., U.S. v. Baylor Univ. Med. Ctr., 736
F.2d 1039, 1042 (5th Cir. 1984), cert. denied, 469
U.S. 1189 (1985); Bernard B. v. Blue Cross & Blue
Shield, 528 F. Supp. 125, 132 (S.D.N.Y. 1981), aff’d,
679 F.2d 7 (2d Cir. 1982); Bob Jones Univ. v.
Johnson, 396 F. Supp. 597, 603 n. 21 (D.S.C. 1974),
aff’d, 529 F.2d 514 (4th Cir.1975); Austin v Blue
Cross Blue Shield of Ala., No. 4:09–cv–1647, 2009
WL 10703738, at *1, n.1 (N.D. Ala. Oct. 16, 2009);
Waris v. HCR Manor Care, No. 07–cv–3344, 2009
WL 330990, at *19 (E.D. Pa. Feb. 10, 2009), aff’d,
on other gr., 365 Fed. App’x. 402 (3d Cir. 2021);
Campen v. Portland Adventist Med. Ctr., No. 3:16–
cv–00792; 2016 WL 5853736, at * 4 (D. Or. Sept.
2, 2016), adopted by 2016 WL 5858670 (D. Or. Oct.
5, 2016); Zamora-Quezada v. HealthTexas Med.
Group. of San Antonio, 34 F. Supp. 2d 433, 440
(W.D. Tex. 1998); People by Vacco v. Mid Hudson
Med. Group, P.C., 877 F. Supp. 143, 149–40
(S.D.N.Y. 1995); Glanz v Vernick, 756 F. Supp. 632,
636 (D. Mass. 1991); Doe v. Centinela Hosp., No.
87–cv–2514 PAR, 1988 WL 81776 (C.D. Cal. June
30, 1988); Bhatt v. Uniontown Hosp., No. 83–2455,
1986 WL 30681, at *4 (W.D. Pa. Mar. 20, 1986); U.S.
v. Univ. Hosp. of the State Univ. of N.Y. at Stony
Brook, 575 F. Supp. 607, 612 (E.D.N.Y. 1983), aff’d
on other gr., 729 F.2d 144 (2d Cir. 1984); U.S. v
Cabrini Med. Ctr., 497 F. Supp. 95, 96 n. 1 (S.D.N.Y.
1980), rev’d on other gr., 639 F.2d 908, 910–11 (2d
Cir. 1981); NAACP v. Wilmington Med. Ctr., Inc.,
453 F. Supp. 280, 329 (D. Del. 1978), Flora v.
Moore, 461 F. Supp. 1104, 1115 (N.D. Miss. 1978).
Because many hospitals receive funds under
Medicare and Medicaid, many of these cases
address both types of funding together. Some of
these cases refer specifically to Part A of Medicare
in holding that the funds are Federal financial
assistance; others refer to Medicare but given that
the defendant is a hospital or other facility that Part
A funding covers, the funds at issue have been Part
A funds.
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insurance or guaranty that falls within
the exception to ‘‘Federal financial
assistance’’ in Title VI.616 In 1977, the
Department subsequently clarified,
however, that this ‘‘explanation
oversimplified the Department’s view of
whether Medicare Part B constitutes
Federal financial assistance.’’ 617 In
adopting this position in its final rule
implementing Section 504, the
Department explained that ‘‘its position
has consistently been that, whether or
not Medicare Part B arrangements
involve a contract of insurance or
guaranty, no Federal financial assistance
flows from the Department to the doctor
or other practitioner under the program,
since Medicare Part B—like other social
security programs—is basically a
program of payments to direct
beneficiaries.’’ 618 Given this
clarification, we will focus primarily
here on the Department’s 1977 rationale
that no Federal financial assistance
flows from the Department to a provider
under the program.
The Department’s 1977 rationale
regarding the payment to beneficiaries
no longer reflects how Medicare Part B
operates. When the Medicare Part B
program was first enacted in 1965,
program beneficiaries generally paid for
services out of pocket and received
partial reimbursement from the
program. That is no longer the most
common method by which providers
receive funds. The Medicare and
Medicaid Act (the ‘‘Medicare Act’’)
currently allows physicians and many
other Part B providers and suppliers to
‘‘accept assignment’’ for Medicare Part B
claims.619 Providers thereby accept
Medicare’s approved amount for a
service and can only charge a
beneficiary co-insurance and a
deductible.620 Providers bill the
Medicare program directly for services
they provide to Part B program
beneficiaries and are paid directly by
the Department.621
Significantly, at the present time,
approximately two-thirds of providers
enrolled in the Medicare Part B program
are ‘‘participating providers,’’ 622 i.e.,
providers that bill and are paid by the
Medicare program. Thus, the
616 41 FR 20296, 20298 (May 17, 1976)
(discussing 42 U.S.C. 2000d–1, d–4).
617 42 FR 22685.
618 Id.; 41 FR 20298.
619 42 U.S.C. 1395u(h)–(i).
620 Lower Costs with Assignment, Medicare.gov,
https://www.medicare.gov/your-medicare-costs/
part-a-costs/lower-costs-with-assignment (last
visited June 15, 2022).
621 Id.
622 Medicare Provider Enrollment Chain and
Ownership System (PECOS), https://
pecos.cms.hhs.gov/pecos/login.do#headingLv1 (last
visited June 15, 2022).
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Department’s primary historical
rationale for its position that Medicare
Part B was not Federal financial
assistance does not reflect the current
operation of the program for the
majority of providers participating in
the program. Those providers have
become direct recipients of Federal
financial assistance. This significant
change in facts provides ample support
for the Department’s change of
interpretation as applied to those
providers.623
Providers commonly known as ‘‘nonparticipating providers’’ also provide
services to Medicare beneficiaries, but
they do not agree to accept Medicare’s
approved amount as full payment, and
can charge up to 15 percent more than
Medicare’s approved amount.624 They
also receive a lower payment rate
through the program.625 Nonparticipating providers must enroll in
the Part B program for their services to
be covered by the program, but do not
receive direct payment from the Part B
program.626 Thus, whereas they are
referred to as ‘‘non-participating’’
because they do not receive direct
Medicare assignment and are not subject
to the usual participating provider fee
limitations like participating providers,
non-participating providers do
participate in the Part B program
overall, and enroll in the program so
that the services they provide to Part B
beneficiaries will be subsidized by the
program. (In contrast, providers referred
to as ‘‘opt-out providers’’ opt out of
Medicare Part B entirely, and Medicare
does not pay for the services these
providers provide to Part B
beneficiaries, either directly to
providers themselves, or by reimbursing
Part B beneficiaries after the fact for
these services.) 627
Given this relationship of nonparticipating providers to the Medicare
Part B program, the Department believes
that non-participating providers are also
recipients of Federal financial assistance
under the principles set forth by the
Supreme Court in Grove City College v.
Bell, where the Court held that Federal
assistance loans provided to students to
cover education-related expenses is
Federal financial assistance to
educational institutions under Title
623 See Nat’l Cable & Telecomms. Ass’n v. Brand
X internet Servs., 545 U.S. 967, 981 (2005) (‘‘[a]n
initial agency interpretation is not instantly carved
in stone. On the contrary, the agency . . . must
consider varying interpretations and the wisdom of
its policy on a continuing basis, for example, in
response to changed factual circumstances . . .’’).
624 42 U.S.C. 1395w–4(g)(1); Lower Costs with
Assignment, supra note 620.
625 Lower Costs with Assignment, supra note 620.
626 42 CFR 424.510.
627 Lower Costs with Assignment, supra note 620.
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IX.628 The Court explained that
‘‘[n]othing . . . [ ] suggests that Congress
elevated form over substance by making
the application of the nondiscrimination
principle dependent on the manner in
which a program or activity receives
Federal assistance. There is no basis in
the statute for the view that only
institutions that themselves apply for
Federal aid or receive checks directly
from the Federal Government are
subject to regulation.’’ 629
Critically, the Court noted that the
Federal financial assistance in question
‘‘was structured to ensure that it
effectively supplements the College’s
own financial aid program.’’ 630 In doing
so, it rejected the argument that student
loans were akin to general assistance
programs such as ‘‘food stamps, Social
Security benefits, welfare payments, and
other forms of general-purpose
governmental assistance to low-income
families.’’ 631 Among the reasons the
Court cited for this rejection were the
fact that ‘‘general assistance programs,
unlike student aid programs, were not
designed to assist colleges and
universities’’ and that ‘‘educational
institutions have no control over, and
indeed perhaps no knowledge of,
whether they ultimately receive Federal
funds made available to individuals
under general assistance programs [like
Social Security], but they remain free to
opt out of Federal student assistance
programs.’’ 632 Entities such as nonparticipating providers are aware of the
flow of Federal financial assistance to
them and are permitted to opt out.
In the Department’s view, the
rationale set forth in Grove City College
counsels in favor of considering nonparticipating providers under Medicare
Part B to be indirect recipients of
Federal financial assistance. Part B
funds, like the Federal student aid
provided to students at issue in Grove
City College, are ‘‘designed’’ to
effectively subsidize health care
providers and suppliers for the health
services and supplies they provide to
program beneficiaries. Program
beneficiaries who see a nonparticipating provider receive a Part B
payment from the program for one
reason only: they have received health
services or supplies from a provider that
has enrolled in the Part B program and
paid for the service out of pocket. The
amount that the provider may charge is
controlled by the terms of the provider’s
628 Grove City Coll. v. Bell, 465 U.S. 555, 565
(1984).
629 Id. at 564.
630 Id. at 565.
631 Id. at n.13
632 Id.
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enrollment agreement in Medicare Part
B. Accordingly, even though a nonparticipating provider does not accept
assignment, it remains a willing
participant in the Medicare Part B
program and it agrees to treat patients
receiving Medicare Part B with the
awareness that its services that will be
subsidized by the Department. In
contrast to general assistance programs,
and similar to the student aid program
at issue in Grove City College, nonparticipating providers thus have
knowledge and control of whether they
receive Federal funds and their
participation status, and remain free to
opt out.633 Further, Title VI, Section
504, Title IX, the Age Act, and this
proposed rule all require entities to sign
an assurance of compliance with these
laws as a condition of receiving Federal
funds.634 Thus both participating and
non-participating providers will have a
choice as to whether to accept the funds
and comply with these civil rights laws
or decline the funds.
Accordingly, the Department’s
principal 1977 rationale regarding the
flow of Federal assistance can no longer
justify excluding Medicare Part B
payments from the definition of Federal
financial assistance. Participating
providers are the direct recipients of
Federal financial assistance; and nonparticipating providers are the indirect
recipients of such assistance.
A second rationale that the
Department has mentioned as potential
support for its past position that
Medicare Part B is not Federal financial
assistance is that Medicare Part B is a
‘‘contract of insurance or guaranty.’’ 635
The Title VI statute 636 and regulations,
and Section 504, Title IX, and Age Act
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633 Id.
634 45 CFR 80.4 (Title VI); § 84.5 (Section 504);
§ 86.4 (Title IX); § 91.33 (Age Act); proposed § 92.5.
635 41 FR 20296, 20298 (May 17, 1976).
636 42 U.S.C. 2000d et seq. The legislative history
of Title VI indicates that the ‘‘contract of insurance
or guaranty’’ exclusion was added to the bills that
became Title VI to address the concern of some
members of Congress that without the exclusion,
federally insured banks providing housing
mortgages would be covered by Title VI and be
prohibited from denying mortgages based on ‘‘the
choice of a neighbor,’’ i.e., engaging in redlining, a
practice now prohibited by the Federal Fair
Housing Act. 110 Cong. Rec. 1345–6 (Statement of
Sen. Pastore); 110 Cong. Rec. 1497–1500 (colloquy
between Rep. Cramer, and Willard W. Wirtz,
Secretary of Labor); 110 Cong. Rec. 1519 (Statement
of Rep. Heller); 110 Cong. Rec. 13377–78 (June 10,
1964) (Statement of Sen. Long),110 Cong. Rec.
13435 (June 10, 1964) (Statement of Sen.
Humphrey). 110 Cong. Rec. 13454–6 (Statement of
Sen. Pastore); 110 Cong. Rec. 13435 (June 10, 1964)
(Statement of Sen. Humphrey). When Medicare was
being enacted, some indications in the legislative
history suggest that Congress assumed that Title VI
would apply to it. See, e.g., 111 Cong. Rec. 15813
(July 7, 1965) (Statement of Sen. Hart).
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regulations 637 exclude a contract of
insurance from the definition of
‘‘Federal financial assistance.’’
Significantly, after initially relying on
this rationale, the Department clarified
that its position did not depend on this
rationale.638 Moreover, this prior
rationale does not provide a strong basis
for interpreting Medicare Part B as
something other than Federal financial
assistance.
First, with respect to Section 1557 in
particular, Congress made clear in the
text of the statute that a ‘‘contract of
insurance’’ can constitute Federal
financial assistance, expressly declining
to include the exception from Title
VI.639 Thus, whatever the meaning of
that exception might be in Title VI, and
in the Title IX, Section 504, and Age Act
regulations, it does not apply to Section
1557.
Second, the Department now is of the
view that Medicare Part B funding is not
covered by that Title VI exception,
because it is not a ‘‘contract of insurance
or guaranty.’’ It is instructive, in this
regard, to consider how the Department
has analyzed Medicare Part A with
respect to the question of what
constitutes Federal financial assistance.
Medicare Part A and Part B are
fundamentally similar in many respects.
Both are Federal programs providing
health-related coverage to eligible
individuals. In both, providers agree to
meet conditions of participation or
coverage in exchange for receiving
payments for their services to eligible
enrolled individuals. In both, payments
come from a Federal trust fund. In both,
the services covered, fees paid, and
other aspects of the program are
governed by a variety of statutes and
regulations. That participation in Part B
is voluntary for eligible individuals does
not make Part B funds a ‘‘contract of
insurance or guaranty,’’ particularly
since some individuals who do not
qualify for ‘‘premium-free’’ Part A
coverage can ‘‘buy-in’’ to Medicare Part
A.640 Part A buy-in has been a feature
of Medicare since 1972, though the
statute has subsequently been amended
to expand eligibility for this option.641
Both Parts contain the word
‘‘insurance’’ in their Titles; 642 yet
637 45 CFR 80.13(f) (Title VI); § 84.3(h) (Section
504); § 86.2(g) (Title IX); § 91.4 (Age Act).
638 42 FR 22685.
639 42 U.S.C. 18116(a).
640 Part A Costs, Medicare.gov, https://
www.medicare.gov/your-medicare-costs/part-acosts (last visited June 15, 2022).
641 Public Law 92–603, 202, 86 Stat. 1329 (Oct.
30, 1972), as amended by, The Omnibus Budget
Reconciliation Act of 1989, Public Law 101–239,
6013, 103 Stat. 2106 (Dec. 19, 1989).
642 42 U.S.C. ch. 7, subch. XVIII, pt. A (Hospital
Insurance Benefits for Aged and Disabled); 42
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Medicare Part A has always been
considered Federal financial assistance
by the Department, notwithstanding this
denomination. Thus, the use of this
term in Part B has no more significance
than it does in Part A. In both programs,
insurance companies serve as Medicare
Administrative Contractors, processing
claims and paying providers 643 as
agents of the Department, not as
insurers of individuals. We note as well
that most of the funding for the Part B
fund comes from Federal and State tax
revenue and interest on investments,
not ‘‘premium’’ payments.644
The Department seeks comment on
the impact that this proposed change
may have on recipients subsidized only
by Medicare Part B funds and no other
sources of Federal financial assistance
from the Department. We also seek
comment on the time that should be
allowed for recipients of Part B funds to
come into compliance with the
applicable statutes and their
implementing regulations and what
resources the Department can provide to
assist newly covered entities in coming
into compliance.
V. CMS Amendments
The 2020 Rule amended ten
provisions in CMS regulations, at least
some of which cover entities that are
also subject to Section 1557, to delete
language that prohibited discrimination
on the basis of sexual orientation and
gender identity.645 These provisions
included regulations governing
U.S.C. ch. 7, subch. XVIII, pt. B (Supplementary
Insurance Benefits for Aged and Disabled).
643 42 U.S.C. 1395kk–1; Medicare Administrative
Contractors, Ctrs. for Medicare & Medicaid Servs.,
https://www.cms.gov/Medicare/MedicareContracting/Medicare-Administrative-Contractors/
MedicareAdministrativeContractors (last visited
June 15, 2022).
644 Tax Policy Ctr., Tax Policy Center Briefing
Book: Key Elements of the U.S. Tax System, https://
www.taxpolicycenter.org/briefing-book/whatmedicare-trust-fund-and-how-it-financed (last
visited June 15, 2022) (indicating SMI trust fund
received over 70% of its 2017 year assets from
general revenue, including individual income taxes,
corporate taxes, and excise taxes).
645 See 85 FR 37160, 37162 (June 19, 2020) (the
provisions that were amended included: Medicaid
and CHIP (42 CFR 438.3(d)(4), § 438.206(c)(2),
§ 440.262); PACE (42 CFR 460.98(b)(3),
§ 460.112(a)); issuers offering coverage in the group
and individual markets (45 CFR 147.104(e));
Exchange-related programs (45 CFR
155.120(c)(1)(ii), § 155.220(j)(2)(i), § 156.200(e),
§ 156.1230(b)(2)). 45 CFR 147.104 applies not only
to issuers subject to Section 1557, but to all health
insurance issuers offering non-grandfathered
individual, small group, and large group health
insurance, and § 156.125(b) applies not only to
issuers subject to Section 1557, but to all health
insurance issuers offering non-grandfathered
individual and small group health insurance.
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Medicaid and CHIP; 646 PACE; 647 health
insurance issuers including issuers
providing essential health benefits
(EHB) and issuers of qualified health
plans (QHPs), and their officials,
employees, agents, and representatives;
States and the Exchanges carrying out
Exchange requirements; and agents,
brokers, or web-brokers that assist with
or facilitate enrollment of qualified
individuals, qualified employers, or
qualified employees.648 The 2020 Rule
stated that in light of the overarching
applicability of Section 1557 to these
programs and entities, the Department
was making these amendments to
ensure greater consistency in civil rights
enforcement across the Department’s
different programs.649 See supra section
II.B. for additional detail.
The Department is committed to
ensuring that all persons should be able
to access health care without being
subjected to sex discrimination, and that
all persons should receive equal
treatment under the law, no matter their
gender identity or sexual orientation.
Accordingly, in this proposed rule, the
Department proposes to amend these
CMS regulations 650 so that they again
identify and recognize discrimination
on the basis of sexual orientation and
gender identity as prohibited forms of
discrimination based on sex. In
addition, the Department proposes to
amend a regulation applying these
protections in CHIP to also apply to
Medicaid fee-for-service programs and
managed care programs. These
proposals are consistent with those
elsewhere in this proposed rule and
would ensure that sexual orientation
and gender identity are added and
promote consistency across HHS
programs of policies and requirements
that prohibit discrimination based on
sexual orientation or gender identity. In
646 The 2020 Rule, at 85 FR 37221, removed
references to sexual orientation and gender identity
as a prohibited basis of discrimination from 42 CFR
438.3(d)(4), § 438.206(c)(2), and § 440.262.
647 The 2020 Rule, at 85 FR 37220–21, removed
references to sexual orientation from 42 CFR
460.98(b)(3) and § 460.112(a). However due to a
publishing error, the text of § 460.112(a) still states
that PACE participants have the right not to be
discriminated against on the basis of sexual
orientation.
648 The 2020 Rule, at 85 FR 37221, removed
references to sexual orientation and gender identity
as a prohibited basis of discrimination from 45 CFR
147.104(e), § 155.120(c)(1)(ii), § 155.220(j)(2)(i),
§ 156.200(e), and § 156.1230(b)(2).
649 85 FR 37162.
650 See 85 FR 37162 (the provisions that were
amended included: Medicaid and CHIP (42 CFR
438.3(d)(4), § 438.206(c)(2), § 440.262); PACE (42
CFR 460.98(b)(3), § 460.112(a)); issuers offering
coverage in the group and individual markets (45
CFR 147.104(e)); Exchange-related programs (45
CFR 155.120(c)(1)(ii), § 155.220(j)(2)(i), § 156.200(e),
§ 156.1230(b)(2)).
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the ‘‘Patient Protection and Affordable
Care Act; HHS Notice of Benefit and
Payment Parameters for 2023’’
published in the Federal Register on
January 5, 2022 (2023 Payment Notice
proposed rule),651 HHS proposed
similar amendments to some of those
same regulations applicable to
Exchanges, QHPs, and certain issuers to
prohibit discrimination based on sexual
orientation and gender identity.652
These provisions were not finalized in
the Final Rule published on May 6,
2022.653 Commenters that provided
comments on the 2023 Payment Notice
proposed rule should not submit
duplicative comments to this proposed
rule as the Department will consider all
comments previously submitted
regarding these proposals in issuing its
final rule.
Prohibiting sex discrimination based
on sexual orientation and gender
identity can lead to improved health
outcomes for members of the LGBTQI+
community. Without such protection,
individuals will likely continue facing
barriers to accessing medically
necessary health care. For example,
without protection from discrimination,
transgender individuals may face
barriers or be denied clinically
appropriate gender-affirming care.
On June 15, 2020, the U.S. Supreme
Court held that Title VII’s prohibition
on employment discrimination based on
sex encompasses discrimination based
on sexual orientation and gender
identity.654 The Bostock majority
concluded that the plain meaning of
‘‘because of sex’’ in Title VII necessarily
included discrimination because of
sexual orientation and gender
identity.655 Subsequently, DOJ’s Civil
Rights Division issued a
memorandum 656 concluding that the
Supreme Court’s reasoning in Bostock
applies to Title IX. As made clear by the
ACA, Section 1557 prohibits
discrimination ‘‘on the ground
prohibited under . . . Title IX.’’ 657
Consistent with Bostock, HHS OCR
issued its Bostock Notification,
interpreting Section 1557’s prohibition
on discrimination on the basis of sex to
include discrimination on the basis of
sexual orientation and gender identity.
Based on this and the statutory
authorities identified below, the
Department also relies on Section 1557
651 87
FR 584 (Jan. 5, 2022).
CFR 147.104(e); § 155.120(c)(1)(ii);
§ 155.220(j)(2)(i); § 156.200(e); § 156.1230(b)(2).
653 87 FR 27208, 27209 (May 6, 2022).
654 Bostock v. Clayton Cnty., 140 S. Ct. 1731
(2020).
655 Id. at 1753–54.
656 Karlan Memo, supra note 46.
657 42 U.S.C. 18116(a).
652 45
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as authority for the proposed
amendments to 45 CFR 155.120,
155.220, 156.200, and 156.1230 as well
as 42 CFR 438.3(d)(4), 42 CFR
438.206(c)(2), and 42 CFR 440.262 in
this proposed rule. CMS is also
proposing a parallel amendment to 45
CFR 147.104 that would prohibit
discrimination on the basis of sex
(including on the basis of sexual
orientation or gender identity)
consistent with the Section 1557
implementing regulations proposed in
this rule but is relying on the separate
authorities identified later in this
discussion. We are also including a
discussion at 45 CFR 156.125 that
clarifies how the proposed change to 45
CFR 156.200 would impact the
nondiscrimination requirements for
plans providing EHB such that plans
subject to EHB requirements would be
prohibited from discriminating on the
basis of sex (including sexual
orientation or gender identity) relying
on separate authorities identified below.
Subpart B of this NPRM discusses the
Section 1557’s prohibition on
discrimination on the basis of sex
(including pregnancy, sex
characteristics, sexual orientation, and
gender identity). This portion of the
preamble focuses on the CMS
freestanding, independent provisions
that have long provided for
nondiscrimination on the basis of sex in
its programs and services. While the
Section 1557 NPRM proposes to include
sex stereotypes, sex characteristics,
pregnancy or related conditions, sexual
orientation, and gender identity as
enumerated forms of sex discrimination,
CMS limits the explicit mention to
gender identity and sexual orientation,
while understanding that discrimination
on the basis of sex stereotypes, sex
characteristics, and pregnancy or related
conditions is prohibited sex
discrimination. We seek comment on
this approach for all of the CMS
provisions addressed in this section.
A. Medicaid and Children’s Health
Insurance Program (CHIP)
In the Medicaid and CHIP managed
care final rule published in the Federal
Register on May 6, 2016,658 CMS
explicitly included prohibitions on
discrimination based on sexual
orientation or gender identity. In that
rulemaking, CMS explained that
adopting protections against
discrimination on these bases was
necessary to assure that care and
services are provided in a manner
consistent with the best interest of
beneficiaries under section 1902(a)(19)
658 81
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of the Social Security Act (‘‘the SSA’’)
and relied on authority under section
1902(a)(4) of the SSA to adopt
regulatory antidiscrimination
protections and obligations for managed
care plans.659 We amended 42 CFR
438.3(d)(4), which prohibits enrollment
discrimination in contracts with
managed care organizations, prepaid
inpatient health plans, prepaid
ambulatory health plans, primary care
case managers, and primary care case
management entities, as well as 42 CFR
438.206(c)(2), which, as amended,
required each managed care
organization, prepaid inpatient health
plan, and prepaid ambulatory health
plan to participate in a ‘‘State’s efforts
to promote the delivery of services in a
culturally competent manner to all
enrollees, . . . regardless of gender,
sexual orientation or gender identity.’’
We also explained that the obligation for
the state plan to promote access and
delivery of services without
discrimination was necessary to assure
that care and services were provided in
a manner consistent with the best
interest of beneficiaries under section
1902(a)(19) of the SSA.660 Therefore, in
the Medicaid and CHIP managed care
2016 final rule, we created a new
provision entitled ‘‘Access and cultural
considerations’’ at 42 CFR 440.262,
requiring states to have methods to
‘‘promote access and delivery of
services in a culturally competent
manner to all beneficiaries, including
those with limited English proficiency,
diverse cultural and ethnic
backgrounds, disabilities, and regardless
of gender, sexual orientation or gender
identity.’’ In addition, 42 CFR 438.3(f)
(which is also applicable to CHIP
managed care entities per § 457.1201(f)),
requires compliance with all applicable
Federal and State laws and regulations,
including Section 1557. The
antidiscrimination provision in
§ 438.3(d)(4) also applied to CHIP
managed care entities under
§ 457.1201(d); those CHIP managed care
regulations apply the terms of the
Medicaid managed care regulations
through existing cross-references. As
explained in the Medicaid and CHIP
managed care 2016 final rule, CMS
believes it is appropriate to align the
requirements for managed care
programs in the Medicaid and CHIP
contexts, including with regard to
beneficiary protections and access to
services.661
659 80 FR 31097, 31147–48 (June 1, 2015); 81 FR
27538–39, 27666.
660 81 FR 27666.
661 80 FR 31169–71, 31173; 81 FR 27757–58,
27765.
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Due to an oversight, the Medicaid and
CHIP managed care 2016 final rule did
not apply the provisions requiring
nondiscrimination as described in 42
CFR 440.262 to fee-for-service CHIP
programs. In the Department’s view,
providing access to services in a nondiscriminatory manner is in the best
interest of all CHIP beneficiaries. CMS
therefore now proposes to rectify that
omission by incorporating 42 CFR
440.262 into CHIP regulations through a
cross-reference at 42 CFR 457.495(e).
Taken together, these protections further
the purpose of CHIP to provide child
health assistance in an effective and
efficient manner that is consistent with
section 2101(a) of the SSA.
CMS now proposes, based on Section
1557 as discussed previously, and its
separate statutory authority under
sections 1902(a)(4) of the SSA (codified
at 42 U.S.C. 1396a(a)(4)) and 2101(a) of
the SSA (codified at 42 U.S.C.
1397aa(a)), to amend 42 CFR
438.3(d)(4), 42 CFR 438.206(c)(2), and
42 CFR 440.262 to again prohibit
Medicaid and CHIP managed care
organizations, prepaid inpatient health
plans, prepaid ambulatory health plans,
primary care case managers, and
primary care case management entities
in managed care programs from
discriminating on the basis of sexual
orientation and gender identity, and to
require managed care plans and State
fee-for-service Medicaid and CHIP
programs to promote access and
delivery of services in a culturally
competent manner to all beneficiaries,
including those with limited English
proficiency, diverse cultural and ethnic
backgrounds, disabilities, and regardless
of gender, sexual orientation or gender
identity. As noted above, the managed
care contracting and service delivery
provisions would also apply to CHIP
managed care entities based on existing
regulations, creating an alignment in the
Medicaid and CHIP managed care
requirements.
As HHS noted in its 2016 Medicaid
CHIP managed care final rule,662 CMS
possesses statutory authority to amend
42 CFR 438.3(d)(4), 42 CFR
438.206(c)(2), and 42 CFR 440.262
under section 1902(a)(4) of the SSA,
which authorizes the Secretary to adopt
methods of administration necessary for
the proper and efficient operation of the
Medicaid state plan; section 1902(a)(19)
of the SSA (codified at 42 U.S.C.
1396a(a)(19)), which requires the
Medicaid state plan to provide
safeguards as necessary to assure that
covered services are provided in a
manner consistent with the best
662 81
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interests of the recipients; and section
2101(a) of the SSA (codified at 42 U.S.C.
1397aa(a)), which permits provision of
funds to States to enable them to initiate
and expand the provision of child
health assistance to uninsured, lowincome children in an effective and
efficient manner. CMS interprets section
1902(a)(19) of the SSA as prohibiting
discrimination in the delivery of
services because such discrimination is
inconsistent with the best interests of
the Medicaid beneficiaries who are
eligible for and receive services. CMS
interprets sections 1902(a)(4) and
2101(a) of the SSA as authorizing CMS
to adopt regulations prohibiting
discrimination on the basis of gender
identity or sexual orientation because
such prohibitions on discrimination are
necessary for the proper and efficient
operation of a state plan, are in the best
interest of beneficiaries, and enable
states to provide child health assistance
in an effective and efficient manner.
Adopting regulations to ensure that
eligible beneficiaries receive services
under these programs is consistent with
the purpose of the Medicaid and CHIP
programs to furnish and expand access
to medical assistance. The proposed
amendments to 42 CFR 438.3(d)(4),
438.206(c)(2), 440.262, and 457.495(e)
would explicitly prohibit discrimination
on the basis of sexual orientation and
gender identity in addition to the
existing prohibitions imposed on
Medicaid and CHIP under Section 1557.
Importantly, adopting a broader
interpretation of what is necessary and
appropriate to ensure proper and
efficient Medicaid and CHIP programs
and to ensure services are delivered in
a manner that is in the best interest of
the beneficiary is warranted in light of
the existing trends in health care
discrimination 663 and to better address
barriers to health equity. Section II.D. of
this NPRM includes an extensive
discussion of LGBTQI+ health
disparities. These CMS conforming
amendments, in addition to the broad
prohibition on discrimination required
under Section 1557, allow CMS to
ensure that its programs and services are
operated without discrimination and
would help address those disparities.
While we are restoring 42 CFR
438.3(d)(4), 438.206(c)(2), 440.262, and
adding 457.495(e), as part of using our
longstanding program authority, Section
1557 requires nondiscrimination in
these programs and services.
663 Thu T. Nguyen et al., Trends for Reported
Discrimination in Health Care in a National Sample
of Older Adults with Chronic Conditions, 33 J. Gen.
Intern. Med. 291 (2018), https://doi.org/10.1007/
s11606-017-4209-5.
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Section 1557 prohibits discrimination
on the basis of sex, importantly
including sexual orientation and gender
identity. CMS is proposing to amend 42
CFR 440.262 to restore the explicit
prohibition against discrimination in
the delivery of services on the basis of
sexual orientation and gender identity.
We also propose to replace ‘‘gender’’
with ‘‘sex’’ and add ‘‘(including sexual
orientation and gender identity)’’ for
consistency with the proposals
elsewhere in this proposed rule, to
ensure that sexual orientation and
gender identity are added, and to
promote consistency across HHS
programs. As adopted in 2016, the
regulation at 42 CFR 440.262 was
described by CMS as an obligation for
the state Medicaid plan to promote
access and delivery of services without
discrimination 664 and the proposal here
reiterates the meaning and scope for this
regulation. By reinstating the explicit
references to sexual orientation and
gender identity as forms of sex
discrimination, this proposal would
amend 42 CFR 440.262 to protect
individuals from discrimination on
those bases in the same way that
discrimination on the basis of limited
English proficiency, disabilities, and
cultural and ethnic backgrounds is
prohibited. We also propose to change
‘‘unique needs’’ in 42 CFR 440.262 to
‘‘individualized needs’’ to more
accurately reflect Medicaid’s goal of
providing person-centered care. As
adopted in 2016, the regulation at 42
CFR 438.206(c)(2) required Medicaid
managed care plans to participate in the
State efforts to promote the delivery of
services in a manner required by 42 CFR
440.262,665 so CMS is proposing to
amend 42 CFR 438.206(c)(2) to reinstate
the references to sexual orientation and
gender identity to align the Medicaid
managed care regulation with the
proposal to amend 42 C.F.R 440.262.
Similarly, CMS is proposing to reinstate
references to sexual orientation and
gender identity in the Medicaid
managed care regulation at 42 CFR
438.3(d)(4) that prohibits Medicaid
managed care plans from discriminating
against individuals eligible to enroll and
from using any policy or practice that
has the effect of discriminating on the
basis of listed characteristics, which
currently include race, color, national
origin, sex, or disability. For consistency
with the proposals elsewhere in this
proposed rule to ensure that sexual
orientation and gender identity are
added and promote consistency across
HHS programs for how protections
against discrimination on the basis of
sexual orientation or gender identify are
reflected in regulation, we propose to
revise the term ‘‘sex’’ in the current
regulation text to ‘‘sex (including sexual
orientation and gender identity)’’ at 42
CFR 438.206(c)(2) and 42 CFR
438.3(d)(4).
CMS also proposes to add a similar
nondiscrimination provision for CHIP,
to apply to fee-for-service and managed
care delivery systems, by incorporating
42 CFR 440.262 into CHIP regulations
through a cross-reference at 42 CFR
457.495(e). Because of existing crossreferences in 42 CFR 457.1201(d) and
457.1230(a), the amendments to the
Medicaid managed care regulations at
42 CFR 438.3(d)(4) and 438.206(c)(2)
would also apply to CHIP managed care
entities.
Finally, the Department proposes that
if any of the provisions at CFR
457.495(e), 42 CFR 440.262, 42 CFR
438.206(c)(2) and 42 CFR 438.3(d)(4) is
held to be invalid or unenforceable by
its terms, or as applied to any person or
circumstance, it shall be severable from
its respective sections and shall not
affect the remainder thereof or the
application of the provision to other
persons not similarly situated or to
other dissimilar circumstances. In
enforcing the nondiscrimination
provisions in these CMS regulations,
HHS will comply with laws protecting
the exercise of conscience and religion,
including RFRA and all other applicable
legal requirements.
B. Programs of All-Inclusive Care for the
Elderly (PACE)
CMS issued an interim final rule
implementing the Programs of AllInclusive Care for the Elderly (PACE) on
November 24, 1999.666 In response to
comments received on the November
24, 1999 interim final rule, in a
December 8, 2006 Final Rule,667 CMS
added references to ‘‘sexual orientation’’
to several PACE regulations intended to
prevent discrimination against PACE
participants, consistent with CMS’
authority under sections 1894(f) and
1934(f) of the SSA. Specifically, CMS
amended 42 CFR 460.98(b)(3) to
prohibit PACE organizations from
discriminating against any participant
in the delivery of required PACE
services based on sexual orientation,
among other bases. Similarly, CMS
modified § 460.112(a) to affirmatively
state that each PACE participant has the
right not to be discriminated against in
the delivery of required PACE services
based on sexual orientation, among
other bases.
Congress authorized PACE under both
Medicare and Medicaid, in sections
1894 and 1934 of the SSA, codified at
42 U.S.C. 1395eee and 42 U.S.C. 1396u–
4, respectively. For a description of the
relevant legislative history, we direct
readers to the December 8, 2006
Medicare and Medicaid Programs;
Programs of All-Inclusive Care for the
Elderly (PACE); Program Revisions final
rule.668 Sections 1894(f) and 1934(f) of
the SSA set forth the requirements for
issuing regulations to carry out sections
1894 and 1934. Sections 1894(f)(2) and
(3) and 1934(f)(2) and (3) include certain
provisions relating to beneficiary and
program protections under PACE.
Sections 1894(f)(4) and 1934(f)(4)
however, provide in identical terms that
‘‘[n]othing in this subsection shall be
construed as preventing the Secretary
from including in regulations provisions
to ensure the health and safety of
individuals enrolled in a PACE program
under this section that are in addition
to those otherwise provided under
paragraphs (2) and (3).’’ This authority
allows CMS to implement regulations to
provide additional protections to ensure
the health and safety of PACE
participants in addition to those
specified in sections 1894(f)(2) and (3)
and 1934(f)(2) and (3).
PACE participants are some of CMS’s
most vulnerable and frail beneficiaries,
with the vast majority dually eligible for
both Medicare and Medicaid. To be
eligible to enroll in a PACE program an
individual must be determined to need
the level of care required under the state
Medicaid plan for coverage of nursing
facility services.669 One of the purposes
of the PACE program is to enable PACE
participants to live in the community
with the support of PACE services as
long as medically and socially feasible,
instead of residing in a nursing facility
or other institutional setting.670 While
PACE participants receive care in a
wide range of settings, including the
PACE center, the home, and inpatient
facilities, given the general
characteristics of the PACE population,
PACE organization staff interact with
PACE participants in much the same
way that nursing facility staff work with
long-term care residents who are not
PACE participants. Given the role of the
PACE organization and the frequent
interactions between PACE staff and
PACE participants, the need to ensure
668 Id.
664 81
FR 27666.
666 64
FR 66234 (Nov. 24, 1999).
667 71 FR 71244 (Dec. 8, 2006).
665 Id.
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670 Id.
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discrimination does not occur is even
greater.
As addressed above, CMS now
proposes, using its authority under
section 1557 of the ACA and its
authorities under sections 1894(f)(4) and
1934(f)(4) of the SSA, to amend PACE
regulations at 42 CFR 460.98(b)(3) and
460.112(a) to explicitly prohibit
discrimination on the basis of sexual
orientation or gender identity.
Revised § 460.98(b)(3) would state
that PACE organizations may not
discriminate against any participant in
the delivery of required PACE services
based on race, ethnicity, national origin,
religion, sex (including sexual
orientation and gender identity), age,
mental or physical disability, or source
of payment. Similarly, we are proposing
to revise 42 CFR 460.112(a) to add
references to ‘‘sexual orientation’’ and
‘‘gender identity’’ to establish a right for
each PACE participant not to be
discriminated against in the delivery of
required PACE services on the basis of
sexual orientation or gender identity.
Revised § 460.112(a) will provide in
relevant part that each PACE participant
has the right not to be discriminated
against in the delivery of required PACE
services based on race, ethnicity,
national origin, religion, sex (including
sexual orientation and gender identity),
age, mental or physical disability, or
source of payment.
In addition, in the proposed rule,
‘‘Patient Protection and Affordable Care
Act; HHS Notice of Benefit and Payment
Parameters for 2023’’ published in the
Federal Register on January 5, 2022
(2023 Payment Notice proposed rule),671
HHS proposed to amend certain
regulations applicable to Exchanges,
qualified health plans (QHPs), and
certain issuers to prohibit
discrimination based on sexual
orientation and gender identity.672 That
proposed rule discussed that LGBTQI+
individuals face pervasive health and
health care disparities,673 and are at
671 87
FR 584 (Jan. 5, 2022).
discussed infra section V.C., the
Department did not finalize these provisions in the
Payment Notice final rule (87 FR 27208, 27209
(May 6, 2022)) because this proposed rule
addressing Section 1557 also would address issues
related to prohibited discrimination based on sex.
Therefore, the Department determined that it would
be most prudent to address the nondiscrimination
proposals related to sexual orientation and gender
identity in this Section 1557 proposed rule to
ensure consistency across the policies and
requirements applicable to entities subject to
Section 1557.
673 See, e.g., Lesbian, Gay, Bisexual, and
Transgender Health, Healthy People 2020,
HealthyPeople.gov, https://www.healthypeople.gov/
2020/topics-objectives/topic/lesbian-gay-bisexualand-transgender-health (last visited June 15, 2022);
Hudaisa Hafeez et al., Healthcare Disparities
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672 As
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higher risk for many concomitant
conditions and that overall, LGBTQI+
people report being in poorer health
than non-LGBTQI+ individuals.674 The
2015 report, LGBT Older Adults in LongTerm Care Facilities, found that elders
in this community are more likely to be
single, childless, estranged from their
biological family, and reliant on families
of choice, such as friends and other
loved ones, for informal support.675
Available research indicates that
nursing home staff may be unfamiliar
with the challenges and stigma faced by
the LGBTQI community.676 Many of
these nursing facilities studied also
failed to have care plans in place that
ensured the safety of their LGBTQ
residents and lacked a meaningful
appreciation for their specific history.677
One survey of nursing home social
workers suggested that more than half of
nursing home staff were ‘‘either
intolerant of homosexuality . . . or
openly negative and condemnatory.’’ 678
Research suggests that nursing home
staff may also fail to provide equal care
to the LGBTQI+ community. For
instance, research has shown that
nursing home staff sometimes fail to
provide basic care such as bathing,
toileting, and feeding for LGBTQI+
residents at higher rates than for
residents who are not, because of staff
refusal to touch LGBTQI+ residents.679
As described earlier in this section,
the functions filled by PACE
organization staff are often similar to
those filled by nursing home staff (e.g.,
bathing, toileting, and feeding). Since
the functions are similar, PACE
organizations would typically employ
people with the same training and
Among Lesbian, Gay, Bisexual, and Transgender
Youth: A Literature Review, 9 Cureus e1184 (2017),
https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC5478215/; Karen I. Fredriksen-Goldsen et al.,
Health Disparities Among Lesbian, Gay, and
Bisexual Older Adults: Results from a PopulationBased Study, 103 A.m. J. Pub. Health 1802 (2013),
https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3770805/; Billy A. Caceres et al., A Systematic
Review of Cardiovascular Disease in Sexual
Minorities, 107 A.m. J. Public Health e13–e21
(2017), https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC5343694/.
674 Daniel, supra note 119.
675 Nat’l Senior Citizens Law Center et al., LGBT
Older Adults in Long-Term Care Facilities (last
updated 2015), https://www.lgbtagingcenter.org/
resources/pdfs/NSCLC_LGBT_report.pdf.
676 Alan Moses, A Second ‘‘Closet’’ for Some
LGBTQ Seniors Entering Nursing Homes, U.S. News
(Aug. 10, 2021), https://www.usnews.com/news/
health-news/articles/2021-08-10/a-second-closetfor-some-lgbtq-seniors-entering-nursing-homes.
677 Id.
678 David Henry Wolfenson, The Risks to LGBT
Elders in Nursing Homes and Assisted Living
Facilities and Possible Solutions, 26 Tul. J. L. &
Sexuality 123 (2017), https://journals.tulane.edu/
tjls/article/view/3020/2812.
679 Id.
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education as nursing home staff.
Therefore, it is reasonable to assume
that nursing home staff and PACE staff
might treat individuals in much the
same way. In fact, since PACE staff are
generally required to have one year of
experience working with the frail or
elderly population,680 which is similar
to the population with which nursing
home staff work, it is also reasonable to
assume that nursing home staff might
transfer to a PACE organization. As a
result, we believe that PACE
participants, regardless of the care
setting, may encounter the same or
similar issues as nursing home residents
when receiving services from the PACE
organization.
As explained earlier in this section of
this proposed rule, research on nursing
home care indicates that LGBTQI+
individuals often do not receive the
health care needed to maintain and
improve their overall health status.
Since PACE participants have
similarities to nursing home residents,
we believe many of the same nursing
home concerns might affect the
provision of the benefits PACE
organizations are required to provide
under § 460.92(a). As discussed supra
section II.B., LGBTQI+ individuals
experience high rates of health
disparities.
The PACE benefit package for all
participants, regardless of the source of
payment, must include all Medicarecovered services; all Medicaid-covered
services, as specified in the State’s
approved Medicaid plan; and other
services determined necessary by the
participant’s interdisciplinary team
(IDT) to improve and maintain the
participant’s overall health status.681
Decisions by the IDT to provide or deny
services must be based on an evaluation
of the participant’s current medical,
physical, emotional and social needs
and current clinical practice guidelines
and professional standards of care
applicable to the particular service.682
Furthermore, the IDT must perform an
initial in-person comprehensive
assessment of each participant.683 This
includes evaluating the physical and
cognitive function and ability of each
participant, the participant’s and
caregiver’s preferences for care,
socialization and availability of family
support, current health status and
treatment needs, and other factors.
These requirements are intended to
ensure that the IDT makes decisions
based on the unique needs of each
680 See
42 CFR 460.64(a)(3).
at § 460.92(a).
682 Id. at § 460.92(b).
683 Id. at § 460.104(a).
681 Id.
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PACE participant. Discriminatory
decision-making is inconsistent with
these overall standards for how PACE
organizations must furnish services.
We believe that expressly prohibiting
discrimination based on sexual
orientation or gender identity in these
regulations could lead to improved
health outcomes for PACE
participants.684 Without robust
protection from such discrimination,
PACE participants may face, or continue
to face, barriers to accessing medically
necessary health care, and PACE
participants who are transgender
individuals may face additional barriers
to, or be denied, clinically appropriate
gender-affirming care.
Sections 1894(f)(4) and 1934(f)(4) of
the SSA provide authority for the
establishment of beneficiary safeguards
to ensure the health and safety of all
PACE participants, including ensuring
they have access to all required PACE
items and services. We are proposing
changes to 42 CFR 460.98(b)(3) and
460.112(a) to ensure the health and
safety of PACE participants by
establishing express protections against
discriminatory actions based on sexual
orientation and gender identity.
Finally, the Department proposes that
if any of the provisions at 42 CFR
460.98(b)(3) and 460.112(a) is held to be
invalid or unenforceable by its terms, or
as applied to any person or
circumstance, it shall be severable from
its respective sections and shall not
affect the remainder thereof or the
application of the provision to other
persons not similarly situated or to
other dissimilar circumstances. In
enforcing the nondiscrimination
provisions in these CMS regulations,
HHS will comply with laws protecting
the exercise of conscience and religion,
including RFRA and all other applicable
legal requirements.
C. Insurance Exchanges and Group and
Individual Health Insurance Markets
LGBTQI+ people face barriers to
obtaining appropriate health care,
including access to insurance and
coverage for needed services. For these
reasons—as discussed in greater detail
throughout this preamble related to
access to nondiscriminatory health
coverage—and given the Department’s
goal to ensure consistency across its
nondiscrimination policies and
programs and entities subject to Section
1557 as discussed previously, the
684 Brian W. Ward et al., U.S. Dep’t of Health &
Human Servs., Ctrs. for Disease Control &
Prevention, National Health Statistics Report:
Sexual Orientation & Health Among U.S. Adults:
National Health Interview Survey, 2013 (2014),
https://www.cdc.gov/nchs/data/nhsr/nhsr077.pdf.
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Department here proposes to amend 45
CFR 147.104, 155.120, 155.220, 156.200,
and 156.1230, so that they explicitly
identify and recognize discrimination
on the basis of sexual orientation and
gender identity as prohibited forms of
discrimination based on sex.
The Department proposed similar
amendments to these same regulations
in the 2023 Payment Notice proposed
rule. However, because this proposed
rule addressing Section 1557 also would
address issues related to prohibited
discrimination based on sex, the
Department determined that it would be
most prudent to address the
nondiscrimination proposals related to
sexual orientation and gender identity
in this proposed rule to ensure
consistency across the policies and
requirements applicable to entities
subject to Section 1557. When issuing a
final rule on the provisions proposed in
this rule, we intend to also respond to
the comments already submitted on the
similar proposal included in the 2023
Payment Notice proposed rule.
Accordingly, there is no need for
entities that commented on these
proposals in the 2023 Payment Notice
proposed rule to submit duplicative
comments.
As described above, Section 1557
prohibits discrimination in health
programs or activities, any part of which
receives Federal financial assistance.
Similarly, as the Department noted in
the 2020 Rule, CMS also possesses
statutory authority to prohibit
discrimination in the Exchanges. CMS
relies on these authorities for the
proposed revisions discussed in section
V.C.1 of the preamble.685 In the
respective preambles to §§ 155.120(c),
155.220(j), 156.200(e), and 156.1230(b),
CMS identifies and discusses the
specific statutory authorities (in
addition to Section 1557) that CMS
relies upon for the proposals to prohibit
discrimination based on sexual
orientation and gender identity. Relying
on authority separate from Section 1557,
CMS also re-proposes the revision and
clarification discussed in section V.C.2
of the preamble, related to §§ 147.104
and 156.125. Section 147.104 applies to
issuers offering non-grandfathered
health insurance coverage in the group
and individual markets, and § 156.125
applies to issuers offering nongrandfathered health insurance coverage
in the small group and individual
markets. Both of these provisions
therefore apply to issuers that may not
be entities covered by Section 1557. For
this reason, CMS does not rely on
Section 1557 authority with respect to
these provisions.
Finally, the Department proposes that
if any of the provisions at 45 CFR
147.104(e), 155.120(c), 155.220(j),
156.200(e), or 156.1230(b) is held to be
invalid or unenforceable by its terms, or
as applied to any person or
circumstance, it shall be severable from
its respective sections and shall not
affect the remainder thereof or the
application of the provision to other
persons not similarly situated or to
other dissimilar circumstances. In
enforcing the nondiscrimination
provisions in these CMS regulations,
HHS will comply with laws protecting
the exercise of conscience and religion,
RFRA and all other applicable legal
requirements.
1. Health Insurance Exchanges
a. Non-interference With Federal Law
and Nondiscrimination Standards
(§ 155.120)
Section 155.120(c) currently provides
that in order to avoid interference and
comply with applicable
nondiscrimination statutes, the states
and the Exchanges must not
discriminate based on race, color,
national origin, disability, age, or sex.
Previously, in the final rule ‘‘Patient
Protection and Affordable Care Act;
Establishment of Exchanges and
Qualified Health Plans; Exchange
Standards for Employers’’ (Exchange
Standards final rule), pursuant to the
authority provided in section
1321(a)(1)(A) of the ACA to regulate the
establishment and operation of an
Exchange, the Department finalized
§ 155.120(c) to also prohibit
discrimination based on sexual
orientation and gender identity.686 The
2020 Rule removed the terms ‘‘sexual
orientation’’ and ‘‘gender identity’’ from
the regulation text. For the reasons
stated earlier in section V.C. of the
preamble, for consistency with the
proposals elsewhere in this proposed
rule, to ensure that sexual orientation
and gender identity are added, and to
promote consistency across HHS
programs, we propose to amend 45 CFR
155.120(c) by revising ‘‘sex’’ to ‘‘sex
(including sexual orientation and
gender identity)’’.
In addition to the Section 1557
authority discussed above, section
1312(a)(1)(A) of the ACA also authorizes
CMS to prohibit discrimination in
Exchanges pursuant to the authority to
establish requirements with respect to
the operation of Exchanges.687 Pursuant
686 77
685 85
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to this authority, HHS finalized in the
Exchange Standards final rule that a
State must comply with any applicable
nondiscrimination statutes, specifically
finalizing that a State must not operate
an Exchange in such a way as to
discriminate on the basis of race, color,
national origin, disability, age, sex,
gender identity, or sexual orientation.
CMS proposes to exercise that same
authority here to amend § 155.120(c) to
again prohibit states and Exchanges
carrying out Exchange requirements
from discriminating based on sexual
orientation and gender identity. Section
1321(a)(1)(A) of the ACA is the same
authority CMS relies upon for
implementation of existing
nondiscrimination protections at
§ 155.120(c) that currently prohibit
discrimination on the basis of race,
color, national origin, disability, age, or
sex.
We seek comment on this proposal.
However, we note that the Department
proposed similar amendments to this
section in the 2023 Payment Notice
proposed rule. Accordingly, there is no
need for entities that commented on
these proposals in the 2023 Payment
Notice proposed rule to submit
duplicative comments.
b. Federally-Facilitated Exchange
Standards of Conduct (§ 155.220)
Section 155.220(j)(2)(i) currently
states that an agent, broker or webbroker that assists with or facilitates
enrollment through a Federallyfacilitated Exchange or assists
individuals in applying for advance
payment of the premium tax credit and
cost-sharing reductions for QHPs sold
through a Federally-facilitated Exchange
must provide consumers with correct
information, without omission of
material fact, regarding the Federallyfacilitated Exchange, QHPs offered
through the Federally-facilitated
Exchange, and insurance affordability
programs, and refrain from marketing or
conduct that is misleading (including by
having a direct enrollment website that
HHS determines could mislead a
consumer to believe they are visiting
HealthCare.gov), coercive, or
discriminates based on race, color,
national origin, disability, age, or sex.
This provision also applies to agents,
brokers, and web-brokers in State-based
Exchanges on the Federal platform
under § 155.220(l). Previously, in the
Patient Protection and Affordable Care
Act; HHS Notice of Benefit and Payment
Parameters for 2017 (2017 Payment
Notice final rule),688 we finalized
§ 155.220(j)(2)(i) to also prohibit
688 81
FR 12204 (May 9, 2016).
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discrimination based on sexual
orientation and gender identity. The
2020 Rule removed the terms ‘‘sexual
orientation’’ and ‘‘gender identity’’ from
the regulation text. For the reasons
stated earlier in section V.C. of the
preamble, for consistency with the
proposals elsewhere in this proposed
rule, to ensure that sexual orientation
and gender identity are added, and to
promote consistency across HHS
programs, the Department proposes to
amend 45 CFR 155.220(j)(2)(i) by
revising ‘‘sex’’ to ‘‘sex (including sexual
orientation and gender identity)’’.
In addition to Section 1557 authority
discussed above, section 1312(e) of the
ACA grants CMS independent statutory
authority to establish procedures for
States to permit agents and brokers to
enroll consumers in QHPs through the
Federally-facilitated Exchanges, as
described in Sections 1312(e) of the
ACA, and the authority to establish
requirements with respect to the
operation of Exchanges, the offering of
QHPs through such Exchanges, and
other requirements as the Secretary
determines appropriate under Sections
1321(a)(1)(A), (B), and (D) of the ACA.
Pursuant to this authority, in the 2017
Payment Notice final rule, HHS
finalized at § 155.220 standards of
conduct for agents and brokers that
assist consumers to enroll in coverage
through the Federally-facilitated
Exchanges to protect consumers and
ensure the proper administration of the
Federally-facilitated Exchanges,
including nondiscrimination standards
at § 155.220(j)(2)(i) that prohibited
agents, brokers and web-brokers
described in paragraph (j)(1) from
discriminating based on sexual
orientation and gender identity. CMS
further explained that such standards of
conduct were necessary to protect
against agent and broker conduct that is
harmful towards consumers, or that
prevents the efficient operation of the
Federally-facilitated Exchanges. CMS
proposes to exercise that same authority
here to amend § 155.220(j)(2)(i) to again
prohibit an individual or entity
described in paragraph (j)(1) from
discriminating based on sexual
orientation and gender identity.
Sections 1312(e) and 1321(a)(1)(A), (B),
and (D) of the ACA are the same
authorities CMS relies upon for
implementation of existing
nondiscrimination protections at
§ 155.220(j)(2)(i).
We seek comment on this proposal.
However, we note that the Department
proposed similar amendments to this
section in the 2023 Payment Notice
proposed rule. Accordingly, there is no
need for entities that commented on
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these proposals in the 2023 Payment
Notice proposed rule to submit
duplicative comments.
c. QHP Issuer Participation Standards
(§ 156.200)
Section 156.200(e) states that a QHP
issuer must not, with respect to its QHP,
discriminate on the basis of race, color,
national origin, disability, age, or sex.
Previously, in the Patient Protection and
Affordable Care Act; Establishment of
Exchanges and Qualified Health Plans;
Exchange Standards for Employers’’
(2012 Exchange Standards) final rule,
we finalized § 156.200(e) to also
prohibit discrimination based on sexual
orientation and gender identity.689 In
the ‘‘Patient Protection and Affordable
Care Act; Standards Related to Essential
Health Benefits, Actuarial Value, and
Accreditation; Final Rule’’ (EHB final
rule), we finalized at § 156.125 that the
nondiscrimination requirements in
§ 156.200 also apply to all issuers
required to provide coverage of EHB,
thereby prohibiting discrimination
based on factors such as sexual
orientation and gender identity.690 (See
further discussion of § 156.125 in
section V.C.2 of this preamble.) The
2020 Rule removed the terms ‘‘sexual
orientation’’ and ‘‘gender identity’’ from
the regulation text. For the reasons
stated earlier in section V.C. of the
preamble, for consistency with the
proposals elsewhere in this proposed
rule, to ensure that sexual orientation
and gender identity are added, and to
promote consistency across HHS
programs, we propose to amend 45 CFR
156.200(e) by revising ‘‘sex’’ to ‘‘sex
(including sexual orientation and
gender identity)’’.
In addition to the Section 1557
authority discussed above, section
1311(c)(1)(A) of the ACA gives CMS the
statutory authority to prohibit
discrimination by QHP issuers.
Accordingly, CMS requires QHP issuers
to comply with applicable state laws
and regulations regarding marketing by
health insurance issuers and not employ
marketing practices or benefit designs
that will have the effect of discouraging
the enrollment of individuals with
significant health needs. CMS is
authorized to interpret and implement
this requirement, and to set additional
requirements for QHPs under its
authority to establish requirements with
respect to the offering of QHPs through
the Exchanges in section 1321(a)(1)(B)
of the ACA.691 Pursuant to this
authority to set QHP standards in
689 77
FR 18310.
FR 12834 (Feb. 25, 2013).
691 85 FR 37218–37221.
690 78
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section 1321(a)(1)(B) of the ACA, HHS
finalized in the 2012 Exchange
Standards final rule requirements at
§ 156.200(e) intended to protect
enrollees and potential enrollees from
discriminatory practices, including on
the basis of sexual orientation and
gender identity. CMS proposes to
exercise that same authority here to
amend § 156.200(e) to again prohibit
QHPs from discriminating based on
sexual orientation and gender identity.
Section 1321(a)(1)(B) of the ACA is the
same authority CMS relies upon for
implementation of existing
nondiscrimination protections at
§ 156.200(e).
We seek comment on this proposal.
However, we note that the Department
proposed similar amendments to this
section in the 2023 Payment Notice
proposed rule. Accordingly, there is no
need for entities that commented on
these proposals in the 2023 Payment
Notice proposed rule to submit
duplicative comments.
d. Direct Enrollment With the QHP
Issuer in a Manner Considered To Be
Through the Exchange (§ 156.1230)
Section 156.1230(b)(2) states that the
QHP issuer must provide consumers
with correct information, without
omission of material fact, regarding the
Federally-facilitated Exchange, QHPs
offered through the Federally-facilitated
Exchange, and insurance affordability
programs, and refrain from marketing or
conduct that is misleading a consumer
into believing they are visiting
HealthCare.gov, coercive, or
discriminates based on race, color,
national origin, disability, age, or sex.
Previously, in the 2017 Payment Notice
final rule (81 FR 12203 (May 9, 2016)),
HHS finalized at § 155.220(j)(2)(i)
standards that prohibited agents,
brokers and web-brokers from
discriminating on the basis of sexual
orientation and gender identity, among
other factors. In the Patient Protection
and Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for
2018 (2018 Payment Notice final rule),
we added this nondiscrimination
standard from § 155.220(j) to
§ 156.1230(b), so that the
nondiscrimination protections on the
basis of sexual orientation and gender
identity also applied to issuers using
direct enrollment on a Federallyfacilitated Exchange.692 The 2020 Rule
removed the terms ‘‘sexual orientation’’
and ‘‘gender identity’’ from the
regulation text. For the reasons stated
earlier in section V.C. of the preamble,
for consistency with the proposals
692 81
FR 94058 (Dec. 22, 2016).
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elsewhere in this proposed rule, to
ensure that sexual orientation and
gender identity are added, and to
promote consistency across HHS
programs, we propose to amend 45 CFR
156.1230(b)(2) by revising ‘‘sex’’ to ‘‘sex
(including sexual orientation and
gender identity)’’.
In addition to Section 1557 authority
discussed above, section 1321(a)(1)(A),
(B), and (D) of the ACA gives CMS
statutory authority to prohibit
discrimination in enrollment through
the Exchanges by issuers of QHPs—
namely the authority to establish
requirements with respect to the
operation of Exchanges, the offering of
QHPs through such Exchanges, and
other requirements as the Secretary
determines appropriate. Pursuant to this
authority, in the 2018 Payment Notice
final rule, HHS finalized at
§ 156.1230(b)(2) standards applicable to
issuers using direct enrollment on a
Federally-facilitated Exchange to require
that issuers refrain from marketing or
conduct that is misleading, coercive, or
discriminatory, including on the basis of
sexual orientation or gender identity.
HHS explained it was adding this
nondiscrimination standard from
§ 155.220(j) to § 156.1230(b) so that the
nondiscrimination protections on the
basis of sexual orientation and gender
identity also applied to issuers using
direct enrollment on a Federallyfacilitated Exchange. HHS proposes to
exercise that same authority here to
amend § 156.1230(b) to again prohibit
issuers using direct enrollment on a
Federally-facilitated Exchange from
discriminating based on sexual
orientation and gender identity.
Sections 1321(a)(1)(A), (B), and (D) of
the ACA are the same authority CMS
relies upon for implementation of
existing nondiscrimination protections
at § 156.200(e).
We seek comment on this proposal.
However, we note that the Department
proposed similar amendments to this
section in the 2023 Payment Notice
proposed rule. Accordingly, there is no
need for entities that commented on
these proposals in the 2023 Payment
Notice proposed rule to submit
duplicative comments.
2. Prohibition of Discrimination—Group
and Individual Health Insurance
Markets
a. Guaranteed Availability of Coverage
(§ 147.104)
Section 147.104(e) states that a health
insurance issuer and its officials,
employees, agents, and representatives
must not employ marketing practices or
benefit designs that will have the effect
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47897
of discouraging the enrollment of
individuals with significant health
needs in health insurance coverage or
discriminate based on an individual’s
race, color, national origin, present or
predicted disability, age, sex, expected
length of life, degree of medical
dependency, quality of life, or other
health conditions. Pursuant to section
1311(c)(1)(A) of the ACA, the HHS
Secretary was required to establish by
regulation criteria for certification that
require QHP issuers to meet marketing
requirements and not employ marketing
practices or benefit designs that will
have the effect of discouraging the
enrollment of individuals with
significant health needs in QHPs. As
discussed in section V.C.2.c. of this
preamble, under the authority of section
1321(a) of the ACA, which provides the
HHS Secretary broad rulemaking
authority with respect to the
establishment and operation of
Exchanges and the offering of QHPs
through such Exchanges, in the 2012
Exchange Standards final rule, CMS
codified a regulation implementing
prohibitions on discrimination by QHP
issuers at §§ 156.200(e) and
156.225(b).693 Under the authority in
section 2702 of the PHS Act as well as
the general rulemaking authority in
section 2792 of the PHS Act, which
provides the HHS Secretary broad
rulemaking authority to promulgate
regulations as may be necessary or
appropriate to carry out the provisions
of title XXVII of the PHS Act, the
‘‘Patient Protection and Affordable Care
Act; Health Insurance Market Rules;
Rate Review’’ final rule adopted a
similar standard in § 147.104(e),
applying this requirement market-wide
to issuers offering non-grandfathered
plans in the group and individual health
insurance markets, regardless of
whether the coverage is offered through
or outside of an Exchange.694
For the proposal to amend § 147.104,
CMS relies on its authorities under
sections 2702 and 2792 of the PHS Act,
which provide the HHS Secretary broad
rulemaking authority to promulgate
regulations as may be necessary or
appropriate to carry out the provisions
of title XXVII of the PHS Act. These are
the same authorities CMS relies upon
for implementation of existing
nondiscrimination protections at
§ 147.104(e). Utilizing these same
authorities to again prohibit
discrimination based on sexual
orientation and gender identity would
be consistent with the authority CMS
relies upon for those existing
693 77
694 78
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FR 13406 (Feb. 27, 2013).
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protections at § 147.104(e) that currently
prohibit discrimination on the basis of
race, color, national origin, present or
predicted disability, age, sex, expected
length of life, degree of medical
dependency, quality of life, or other
health conditions.
CMS does not propose to rely on
Section 1557 authority for this
amendment for two primary reasons.
First, § 147.104 applies to nongrandfathered health insurance coverage
in the individual or group market, and
not all of such issuers will receive
Federal financial assistance such that
they would be subject to Section 1557.
Second, under PHS Act section 2723,
states have primary enforcement
authority over issuers with respect to
regulations implementing title XXVII of
the PHS Act, including § 147.104. If
CMS determines that a state is not
substantially enforcing a provision in
title XXVII, then CMS may enforce the
provision’s requirements. Because states
would not have authority to enforce
Section 1557, CMS is of the view that
partial reliance on Section 1557
authority could unnecessarily
complicate enforcement efforts.
For the reasons stated earlier in
section V.C. of the preamble, for
consistency with the proposals
elsewhere in this proposed rule, to
ensure that sexual orientation and
gender identity are added, and to
promote consistency across HHS
programs, we propose to amend 45 CFR
147.104(e) by revising ‘‘sex’’ to ‘‘sex
(including sexual orientation and
gender identity)’’.
We seek comment on this proposal.
However, we note that the Department
proposed similar amendments to this
section in the 2023 Payment Notice
proposed rule. Accordingly, there is no
need for entities that commented on
these proposals in the 2023 Payment
Notice proposed rule to submit
duplicative comments.
b. Prohibition on Discrimination
(§ 156.125)
Elsewhere in this rule, we propose to
amend § 156.200(e) to prohibit
discrimination based on sexual
orientation and gender identity. If these
proposed nondiscrimination protections
are finalized, § 156.125(b) would
accordingly require issuers providing
EHB to comply with such
nondiscrimination requirements.
Specifically, § 156.125(b) states that an
issuer providing EHB must comply with
the requirements of § 156.200(e), which
currently states that a QHP issuer must
not, with respect to its QHP,
discriminate on the basis of race, color,
national origin, disability, age, or sex.
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HHS previously codified
nondiscrimination protections based on
sexual orientation and gender identity at
§ 156.200(e), simultaneously requiring
that issuers providing EHB comply with
such requirements by virtue of the
cross-reference in § 156.125(b) to
§ 156.200(e). The 2020 Rule
amendments removed from § 156.200(e)
any reference to sexual orientation and
gender identity. As discussed in section
V.C.1.c of the preamble, we propose to
amend 45 CFR 156.200(e) by revising
‘‘sex’’ to ‘‘sex (including sexual
orientation and gender identity)’’.
If the proposals at § 156.200(e) are
finalized, issuers providing EHB would
again be required under § 156.125(b) to
comply with nondiscrimination
protections in § 156.200(e) that prohibit
discrimination on the basis of sexual
orientation and gender identity.
Section 1302(b) of the ACA also gives
CMS the statutory authority to prohibit
discrimination in the small group and
individual markets pursuant to the
authority to define EHB at section
1302(b) of the ACA. The statute
specifies that in defining EHB the
Secretary must take into account the
health care needs of diverse segments of
the population, including women,
children, persons with disabilities, and
other groups. The EHB requirements
apply to non-grandfathered health
insurance coverage in the individual
and small group markets under section
2707(a) of the PHS Act. CMS has the
authority to interpret and implement
these provisions under its general
rulemaking authorities in sections
1321(a)(1)(B) and (D) of the ACA and
section 2792 of the PHS Act. Pursuant
to those authorities, HHS finalized in
the EHB final rule that § 156.125
prohibits benefit discrimination on the
grounds articulated by Congress in
section 1302(b)(4) of the ACA, as well
as those in § 156.200(e), which at the
time included race, color, national
origin, disability, age, sex, gender
identity, and sexual orientation. It is
under that same exercise of authority
here that § 156.125 would again prohibit
discrimination on the basis of sexual
orientation and gender identity if the
proposed changes to include such
factors in the nondiscrimination
protections at § 156.200(e) are finalized.
Sections 1302(b) and 1321(a)(1)(B) and
(D) of the ACA and sections 2707(a) and
2792 of the PHS Act are the same
authorities CMS relies upon for
implementation of existing
nondiscrimination protections at
§ 156.125. Relying on these same
authorities to again prohibit
discrimination based on sexual
orientation and gender identity at
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§ 156.125 by cross-reference to the
nondiscrimination protections at
§ 156.200(e) would be consistent with
the authority CMS relies upon for the
existing protections at § 156.125 that
prohibit discrimination on the basis of
race, color, national origin, disability,
age, or sex by cross-reference to
§ 156.200(e).
CMS does not rely on Section 1557
authority for this amendment for the
same two primary reasons described in
section V.C.2.a of this preamble. First,
§ 156.125 applies to issuers offering
non-grandfathered health insurance
coverage in the individual or small
group market, and not all of such issuers
will receive Federal financial assistance
such that they would be subject to
Section 1557. Second, under PHS Act
section 2723, states have primary
enforcement authority over issuers with
respect to regulations implementing title
XXVII of the PHS Act, including
§ 156.125. If CMS determines that a state
is not substantially enforcing a
provision in title XXVII, then CMS may
enforce the provision’s requirements.
Because states would not have authority
to enforce Section 1557, CMS is of the
view that partial reliance on Section
1557 authority could unnecessarily
complicate enforcement efforts.
We seek comment on this proposal.
However, we note that the Department
proposed similar amendments to this
section in the 2023 Payment Notice
proposed rule. Accordingly, there is no
need for entities that commented on
these proposals in the 2023 Payment
Notice proposed rule to submit
duplicative comments.
VI. Executive Order 12866 and Related
Executive Orders on Regulatory Review
A. Regulatory Impact Analysis
We have examined the impacts of the
proposed rule under E.O. 12866, E.O.
13563, the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4). E.O.’s 12866 and 13563 direct
us to assess all costs and benefits of
available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). This
proposed rule is an economically
significant regulatory action as defined
by E.O. 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because the costs of the proposed rule
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are small relative to the revenue of
covered entities, including covered
small entities, and because even the
smallest affected entities would be
unlikely to face a significant impact, we
propose to certify that the proposed rule
will not have a significant economic
impact on a substantial number of small
entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) generally
requires us to prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $165
million, using the most current (2021)
Implicit Price Deflator for the Gross
Domestic Product. This proposed rule is
not subject to the Unfunded Mandates
Reform Act because it falls under an
exception for regulations that establish
or enforce any statutory rights that
prohibit discrimination on the basis of
race, color, religion, sex, national origin,
age, handicap, or disability.695
The Background and Reasons for the
Proposed Rulemaking sections at the
beginning of this preamble contain a
summary of this proposed rule and
describe the reasons it is needed.
1. Summary of Costs and Benefits
This analysis quantifies several
categories of costs to covered entities
and to the Department under the
proposed rule. Specifically, we quantify
costs associated with covered entities
training employees, revising policies
and procedures, and costs associated
with notices, including the notice of
nondiscrimination and notice of
availability of language assistance
services and auxiliary aids and services.
We quantify costs associated with
provisions of the proposed rule related
to documenting training activities
performed under the proposed rule. We
also quantify incremental costs
associated with expanded coverage for
gender-transition-related medical care.
We conclude that the proposed rule
would result in annualized costs over a
5-year time horizon of $560 million or
47899
$551 million, corresponding to a 7% or
a 3% discount rate. This analysis also
addresses uncertainty in costs
associated with notices and expanded
gender-transition-related medical care,
which is discussed in greater detail in
the main body of the analysis. We
separately report a full range of cost
estimates of about $427 million to
$1,093 million using a 7% discount rate,
and a full range of cost estimates of
about $417 million to $1,084 million
using a 3% discount rate.
In addition to these quantified cost
estimates, the main analysis includes a
discussion of costs that we do not
quantify, and a discussion of the
potential benefits under the rule that we
similarly do not quantify. In addition to
the impacts that we quantify, this
proposed rule could also result in
increases in premiums, which would
result in increases in Exchange user fees
and Federal expenditures for advance
payments of the premium tax credit. We
request comments on our estimates of
the cost and benefits of this proposed
rule, including the impacts that are not
quantified in this analysis.
TABLE 1—ANNUALIZED COSTS OF THE PROPOSED RULE
[$ millions/year (percent)]
Primary estimate
Low estimate
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$560 ...........................................................
551 .............................................................
$427
417
a. Baseline Conditions
Section 1557 prohibits an individual
from being excluded from participation
in, denied the benefits of, or otherwise
subjected to discrimination on the basis
of race, color, national origin, sex, age,
or disability in certain health programs
and activities. It applies to any health
program or activity, any part of which
is receiving Federal financial assistance,
and to any program or activity that is
administered by an Executive Agency or
any entity established under Title I of
the ACA.696 On May 18, 2016, the
Department published a final rule to
implement Section 1557 under the
statute and 5 U.S.C. 301. On June 19,
2020, the Department published a final
rule that revised the Department’s
approach to implementing Section 1557.
As described in the Background section
of this preamble in greater detail,
neither final rule was fully implemented
as published, and certain provisions of
the 2020 Rule remain the subject of
695 2
U.S.C. 1503(2).
U.S.C. 18116.
18:38 Aug 03, 2022
Year dollars
$1,093
1,084
FR 27984 (May 25, 2021).
85 FR 37160, 37235 (June 19, 2020) (‘‘The
Department assumes sunk costs cannot be
698 E.g.,
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Discount rate
2020
2020
ongoing litigation. The Background
section of the preamble also discusses
the Department’s May 10, 2021 Bostock
Notification, in accordance with the
Supreme Court’s decision in Bostock
and based on the plain language of Title
IX, that the Department would interpret
Section 1557’s prohibition on sex
discrimination to include (1)
discrimination on the basis of sexual
orientation and (2) discrimination on
the basis of gender identity.697
The baseline scenario of no further
regulatory action is substantially
informed by the RIAs published with
the 2016 and 2020 Rules. The 2016 RIA
identified five sources of monetized
costs: training and familiarization,
enforcement, notice publication, sex
discrimination policy and procedure
changes, and language access plans. The
bulk of the monetary impacts identified
in the 2016 RIA occur in the first two
years under the final rule, with costs
697 86
696 42
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High estimate
7
3
Period covered (percent)
2024–2028
2024–2028
continuing in future years only for
enforcement and language access plans.
The 2020 RIA adopted many of the
assumptions contained in the 2016 RIA.
For example, it assumed that many of
the initial activities anticipated under
the 2016 rule were performed, and that
the first two years of costs attributable
to the 2016 Final Rule were incurred.698
The 2020 RIA identifies cost savings
only ‘‘from the repeal of (1) the
provision on the incentive for covered
entities to develop language access
plans and (2) the provisions on notice
and taglines.’’ The 2020 RIA also
identifies costs in the first year ‘‘on
covered entities’ voluntary actions to retrain their employees on, and adopt
policies and procedures to implement,
the legal requirements of this final
rule.’’
In establishing a baseline scenario,
this analysis similarly maintains a
number of assumptions and estimates
contained in prior analyses. For
recovered by this rule, and therefore that initial
language access plan development costs attributable
to the 2016 Rule cannot be recovered.’’).
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example, the baseline scenario includes
some ongoing costs that are attributable
to the 2016 Rule, such as the costs of
enforcement. The 2016 RIA estimated
that the costs of enforcement would be
$98.2 million (reported in 2020 dollars),
which we adopt as the costs under both
the baseline and proposed rule
scenarios. Similarly, we adopt the
assumption in the 2020 RIA that
covered entities continue to provide
ongoing training attributable to the 2016
Rule, which was not impacted by the
2020 Rule. We include these ongoing
training activities, including annual
refresher training for returning
employees and training for new
employees, in the baseline scenario of
no regulatory action. In the next section,
we discuss the incremental costs of the
proposed rule, which exclude ongoing
costs attributable to prior rulemaking.
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b. Costs of the Proposed Rule
This analysis anticipates that the
proposed rule would result in one-time
costs to covered entities to train
employees and revise policies and
procedures. The proposed rule would
result in costs associated with a revised
approach to notices, including the
notice of nondiscrimination and notice
of availability of language assistance
services and auxiliary aids and services.
The proposed rule would also result in
costs associated with provisions related
to documenting training activities
performed under the proposed rule. The
proposed rule might result in additional
costs associated with expanded
coverage for gender-transition-related
medical care. We discuss the potential
costs associated with this expanded
coverage and the potential that some or
all of these costs would be offset by
reductions in spending on other types of
care. The analysis also discusses other
potential costs of the proposed rule that
we do not quantify.
Training
The Department anticipates that some
covered entities would incur costs to
train or retrain employees under the
proposed rule. To calculate the costs
related to training, we follow an
approach common to both the 2016 and
2020 RIAs. Both analyses adopted an
estimate of 275,002 covered entities that
would train their employees on the
requirements and used this figure as the
basis for calculating the total costs. The
2020 RIA adjusted this figure
downwards by 50%, anticipating that
some covered entities would not modify
their procedures in response to the 2020
Final Rule, and would therefore not
need to offer new training. Both RIAs
anticipated that employers would most
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likely train employees who interact with
the public and recognized that the
percentage of employees that interact
with patients and the public vary by
covered entity. To account for this, the
analyses adopted a central estimate of
50% of staff at covered entities that
received one-time training on the
requirements of the regulation.
Both RIAs reported the number of
employees at covered entities by
occupation category. To monetize the
total costs of training, the RIAs adopted
a value of time based on the average
fully loaded wage rate for each
occupation, combined with an
assumption about the duration of the
training. The 2016 RIA assumed that
50% of total employees at covered
entities would receive training, while
the 2020 RIA assumed that 25% of
employees would receive training. Both
RIAs assumed the typical training
would last one (1) hour. For the purpose
of this analysis, we assume that 75% of
total employees at covered entities
would receive training, and that this
training would last one (1) hour. This
estimate is consistent with an
assumption that all covered entities
would revise their policies and
procedures under the proposed rule,
and that most employees at covered
entities would receive training.
As a necessary first step in calculating
the incremental total costs of training
attributable to the proposed rule, we
have collected the most recent available
data on the number of employees that
would likely undergo training under the
proposed rule, and data on the average
wage rate by occupation for these
employees.
The first category of health care staff
that may receive training comprises
health diagnosing and treating
practitioners. This category includes
physicians, dentists, optometrists,
physician assistants, occupational,
physical, speech and other therapists,
audiologists, pharmacists, registered
nurses, and nurse practitioners. The
U.S. Bureau of Labor Statistics (BLS)
Occupational code for this grouping is
29–1000, and the 2020 reported count
for this occupational group is
approximately 5.6 million, with average
loaded wages of $101.16 per hour.
The second category of health care
staff that the Department assumes will
receive training comprises degreed
technical staff (Occupation code 29–
2000) and accounts for 2.9 million
workers with average loaded wages of
$47.10 per hour. Technicians work in
almost every area of health care: x-ray,
physical, speech, psychiatric, dietetic,
laboratory, nursing, and records
technicians, to name but a few areas.
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The third category of health care staff
that the Department assumes will
receive training comprises non-degreed
medical assistants (Occupation code 31–
0000), and includes psychiatric and
home health aides, orderlies, dental
assistants, and phlebotomists. Health
care support staffs (technical assistants)
operate in the same medical disciplines
as technicians, but often lack
professional degrees or certificates. The
Department refers to this workforce as
non-degreed, compared to medical
technicians who generally have degrees
or certificates. There are approximately
5.9 million individuals employed in
these occupations in the health care and
social assistance sector, with average
loaded wages of $30.72 per hour.
The fourth category of health care
staff that the Department assumes will
receive training is health care managers
(approximately 0.4 million individuals
based on BLS data for Occupation code
11–9111), with average loaded wages of
$114.24 per hour.
The fifth category of health care staff
that the Department assumes will
receive training is office and
administrative assistants—Office and
Administrative Support Occupation
(Occupation code 43–0000). These
workers are often the first staff patients
encounter in a health facility and,
because of this, covered entities might
find it important that staff, such as
receptionists and assistants, receive
training on the regulatory requirements.
Approximately 2.7 million individuals
were employed in these occupations in
health facilities in 2020, with average
loaded wages of $38.50 per hour. The
Department assumes that outreach
workers are included in the five
categories listed above.
These figures sum to 17.4 million
employees at covered entities, of which
we assume 13.1 million would receive
training attributable to the proposed
rule. Across the five occupation
categories, we compute a weighted
hourly wage rate of $29.59, or a
weighted fully loaded hourly wage rate
of $59.18. Assuming that the average
training takes one (1) hour and adopting
a value of time based on fully loaded
wage rates, we estimate the total cost of
training of about $775 million, which
would be incurred in the first year. As
a sensitivity analysis, we considered the
scenario of covered entities providing
training to all employees, not just
employees who interact with the public.
Under this scenario, the total cost of
training would increase, to about $1.0
billion. These costs are likely overstated
since this training may supplement or
replace expected annual or other
ongoing training activities at covered
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entities. To the extent that covered
entities reduce time spent on other
training activities, these costs would
offset some of the total costs attributable
to the proposed rule.
In addition to the first-year training
costs, we anticipate that the proposed
rule would result in additional costs
associated with ongoing training,
including annual refresher training for
returning employees or and training for
new employees. As discussed in the
Baseline Conditions section, we assume
that many covered entities are routinely
carrying out these activities, absent
further regulatory action. However, we
anticipate that the proposed rule would
result in a larger share of employees at
covered entities receiving such training.
To quantify the change in training
activities between the baseline scenario
and the proposed rule scenario, we take
the difference between the share of
employees receiving training under the
baseline scenario and the proposed rule
scenario. We carry through an
assumption from the 2016 RIA, which
assumed that 50% of total employees at
covered entities receive training and
compare this to an assumption in this
proposed RIA that 75% of total
employees at covered entities would
receive training. This yields an estimate
of 25% of total employees at covered
entities that would receive training in
subsequent years under the proposed
rule. We adopt the same weighted
hourly wage estimate, number of
employees, and estimate the total cost of
ongoing annual training costs of $258
million. These costs would occur in
years two through five in the time
horizon of this analysis.
Revising Policies and Procedures
As discussed above, the Department
anticipates that all covered entities, or
approximately 275,002 entities, would
revise their policies and procedures
under the proposed rule, with half of
these entities requiring fewer revisions.
For covered entities with more
extensive revisions, we adopt the
estimates contained in the 2020 RIA,
with four (4) total hours spent on
revisions per entity. Of these, three
would be spent by a mid-level manager
equivalent to a first-line supervisor
(Occupation code 43–1011), at a cost of
$56.96 per hour after adjusting for nonwage benefits and the indirect costs,
while an average of one hour would be
spent by executive staff equivalent to a
general and operations manager
(Occupation code 11–1021), at a cost of
$104.80 per hour after adjusting for nonwage benefits and indirect costs. For
covered entities with less extensive
revisions, we assume two total hours
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spent on revisions per entity. Of these,
one would be spent by a mid-level
manager, and one would be spent by
executive staff.
We monetize the time spent on
revising policies and procedures by
estimating a total cost per entity of
$275.68 or $161.76, depending on the
extent of the revisions. For the 137,501
covered entities with more extensive
revisions, we estimate a cost of about
$37.9 million. For the 137,501 covered
entities with less extensive revisions,
we estimate a cost of about $22.2
million. We estimate the total cost
associated with revisions to policies and
procedures under the proposed rule of
$60.1 million.
The above estimates of time and
number of entities that would choose to
revise their policies under the
regulation are approximate estimates
based on general BLS data. Due to the
wide range of types and sizes of covered
entities, from complex multi-divisional
hospitals to small neighborhood clinics
and physician offices, the above
estimates of time and number of entities
that would choose to revise their
policies under the regulation is difficult
to calculate precisely.
Notices
The proposed rule would require a
covered entity to provide a notice of
nondiscrimination to participants,
beneficiaries, enrollees, and applicants
of its health program or activity, and
members of the public. It also would
require the 275,002 covered entities to
provide a notice of availability of
language assistance services and
auxiliary aids and services. These
provisions resemble elements of the
2016 Rule that were repealed in the
2020 Rule; however, the approach under
the proposed rule provides a narrower
set of situations where covered entities
would be required to provide these
notices. Both types of notices are
required (1) on an annual basis; (2) upon
request; (3) at a conspicuous location on
the covered entity’s health program or
activity website; and (4) in clear and
prominent physical locations where the
health program or activity interacts with
the public.
The notice of availability of language
assistance services and auxiliary aids
and services is required in the following
electronic and written communications
related to the covered entity’s health
programs and activities: (1) notice of
nondiscrimination required by proposed
§ 92.10; (2) notice of privacy practices
required by 45 CFR 164.520; (3)
application and intake forms; (4) notices
of denial or termination of benefits or
services, including Explanations of
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Benefits (EOBs) and notices of appeal
and grievance rights; (5)
communications related to a person’s
rights, eligibility benefits, or services
that require or request a response from
a participant, beneficiary, enrollee, or
applicant; (6) communications related to
a public health emergency; (7) consent
forms and instructions related to
medical procedures or operations,
medical power of attorney, or living will
(with an option of providing only one
notice for all documents bundled
together); (8) discharge papers; (9)
complaint forms; and (10) patient and
member handbooks.
For the purposes of the analysis, we
base our estimates of the number of
communications containing these
notices on a subset of the
communications identified in the 2020
RIA. We include communications that
are EOBs. The Department received
feedback regarding the financial burden
imposed by applying the notice and
tagline requirements to EOBs. EOBs are
typically an individual’s first, and often
only, notice of a denial or termination
of benefits or services, and as such the
notice and tagline requirements are
essential in this context to ensure timely
and equitable access to appeals
processes. Covered entities may provide
individuals with the option to opt out
of receiving these notices on an annual
basis, which will reduce the cost and
burden associated with these
requirements. In addition, as enrollees,
participants, and beneficiaries
increasingly elect to receive EOBs
electronically, we expect the cost of
these requirements to decrease over
time. We adopt the other estimates as a
reasonable proxy for the number of
communications that would be
anticipated under the proposed rule.
These estimates are intended to
encompass all categories of notices
required under the proposed rule. Table
2 below reports the number of
communications containing notices
anticipated under the proposed rule and
presents the costs of these
communications. Our cost estimates
reflect a wide range of uncertainty in the
cost per communication. For our
primary scenario, we adopt a central
estimate of the average costs to print
and fold paper forms containing
prescribing information of $0.05
(calculated as the midpoint estimate of
a range from $0.03 to $0.07), reported in
2010 dollars.699 We explore the
699 U.S. Dep’t of Health & Human Servs., Food &
Drug Admin., Electronic Distribution of Prescribing
Information for Human Prescriptions Drugs,
Including Biological Products (Proposed Rule), 79
FR 75506 (Dec. 18, 2014).
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sensitivity of the overall cost estimates
under a low-cost ($0.035 per unit) and
high-cost ($0.32 per unit) scenario,
reported in 2018 dollars, which matches
the range contained in the 2020 RIA. We
adjust these per-unit cost inputs for
inflation to 2020 price levels using the
Implicit Price Deflator, resulting in a
primary per-unit cost estimate of about
$0.06 and a full range of about $0.04 to
$0.33.700 Combining these per-unit cost
estimates with the count of each notice
results in a primary estimate of $78.4
million, with a range of estimates
between $47.8 million and $437.2
million. Following the approach in the
2020 RIA, we adjust this figure
downwards by 50% to account for the
lower cost of electronic
communications. For this adjustment,
we adopt a measure of the share of
respondents reporting that they used a
‘‘Digital (mobile app or website)’’
method to contact or interact with their
health care insurer in the last year when
viewing an online statement.701 We
anticipate that the share of
communications occurring online will
increase over time, but have not
accounted for a trend for the 5-year time
horizon of this analysis. This
adjustment results in a primary estimate
of the adjusted annual total of $78.4
million, with a range of costs between
$23.9 million and $218.6 million. These
costs would occur in each year of the
time horizon of the analysis.
TABLE 2—COST OF NOTICE PROVISIONS
[2020 dollars]
Count
(millions)
Cost element
Low
Primary
High
Eligibility and enrollment communications ...............................
Annual notice of benefits .........................................................
Explanations of benefits—hospital admissions .......................
Explanations of benefits—physician visits ...............................
Medical bills—hospital admissions ..........................................
Medical bills—physician visits .................................................
17.7
123.0
96.0
941.0
11.0
99.0
$0.7
4.6
3.6
34.9
0.4
3.7
$1.1
7.5
5.8
57.3
0.7
6.0
$6.0
41.8
32.6
319.5
3.7
33.6
Total, Unadjusted .............................................................
Total, Adjusted for Electronic Delivery .............................
1287.7
1030.2
47.8
23.9
78.4
39.2
437.2
218.6
The proposed rule would require
covered entities to contemporaneously
document certain other activities
performed under the proposed rule.
This includes activities such as
employees’ completion of the training
required by this section in written or
electronic form. The proposed rule also
requires covered entities to retain
certain records. These and other
requirements, and the associated cost
estimates, are discussed in greater detail
in the PRA Section.
The costs associated with retaining
records related to grievances filed with
a covered entity is the time spent by the
staff of covered entities to store the
complaints for no less than three (3)
years. We calculate the costs of labor as
one (1) employee per covered entity
with more than 15 employees
(41,250) 702 spending 10 hours to store
complaints and the associated records
required under proposed § 92.8(c)(2)
each year. We assume that
administrative or clerical support
personnel would perform these
functions. The mean hourly wage for
this occupation is $17.38 per hour,
which we double to account for
overhead and other indirect costs. We
estimate the costs of retaining records
related to grievances filed at all covered
entities would be $14.3 million
annually ($17.38 × 2 × 10 × 41,250). This
estimation approach will overstate the
costs if many covered entities already
retain complaint information.
The costs associated with
documenting employee training is the
time spent by the staff of covered
entities to (a) create training attendance
forms; and (b) store the training sign-up
sheet. We calculate the costs of labor as
one (1) employee spending 15 minutes
(0.25 hours) to create the sign-up sheet
during the first year and one (1)
employee spending one (1) hour
collecting and storing the attendance
forms the first year and subsequent
years. We assume that administrative or
clerical support personnel would
perform these functions. The mean
hourly wage for this occupation is
$17.38 per hour, which we double to
account for overhead and other indirect
costs. We estimate the costs of
documenting employee training would
be $11.9 million in the first year ($17.38
× 2 × 1.25 × 275,002) and $9.6 million
in subsequent years ($1.738 × 2 × 1 ×
275,002).
700 Gross Domestic Product: Implicit Price
Deflator (GFPDEF), Fed. Reserve Bank of St. Louis,
https://fred.stlouisfed.org/series/GDPDEF (last
visited June 15, 2022).
701 Saurabh Gupta et al., HFS Res. & Cognizant,
Health Consumers Want Digital: It’s Time for Health
Plans to Deliver, p. 4 (2021), https://
www.cognizant.com/us/en/documents/hfs-health-
consumers-want-digital-its-time-for-health-plans-todeliver.pdf.
702 This estimate is consistent with the 2016
Rule’s Regulatory Impact Analysis: ‘‘Of the 275,002
covered entities, approximately 15% employ more
than 15 employees, resulting in approximately only
slightly more than 41,250 covered entities being
required to have grievance procedures and
designate a responsible official.’’ 81 FR 31375,
31452 (May 18, 2016).
703 State of Cal., Dep’t of Ins., Economic Impact
Assessment Gender Nondiscrimination in Health
Insurance, p. 1 (Apr. 13, 2012), https://
translaw.wpengine.com/wp-content/uploads/2013/
04/Economic-Impact-Assessment-GenderNondiscrimination-In-Health-Insurance.pdf.
Documentation Requirements
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Expanding Coverage for GenderTransition-Related Medical Care
In addition to the cost some covered
health insurance issuers and plans may
incur for revising policies and
procedures to comply with the rule,
there is a possibility that such issuers
and plans may incur a de minimis cost
related to the cost of coverage for
gender-transition-related medical care.
Various studies, however, suggest that
any such increased costs will likely be
negligible, and that any increases may
be offset by savings from decreased
utilization of other services.
In April 2012, the California
Department of Insurance conducted an
Economic Impact Assessment on
Gender Nondiscrimination in Health
Insurance that found that covering
transgender individuals under
California’s private and public health
insurance plans would have an
‘‘insignificant and immaterial’’ impact
on costs.703 This conclusion was based
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on evidence of low utilization and the
estimated number of transgender
individuals in California. The
transgender population of California
was estimated to range between
0.0022% and 0.0173%.704 The study
revealed that, contrary to common
assumptions, not all transgender
individuals seek surgical intervention,
and that gender-affirming health care
differs according to the needs and preexisting conditions of each
individual.705 Despite expecting a
possible spike in demand for benefits
due to former or current unmet demand,
the California Insurance Department
concluded that any increased utilization
that might occur over time is likely to
be so low that any resulting costs
remain actuarially immaterial.706 The
Assessment notes the experience of one
employer that initially established
premium surcharges to cover the
anticipated cost of transition-related
care, reporting that the employer
subsequently eliminated the surcharges
because they found that the funds
collected were nearly 15 times the
amount expended on care.707 While it
did not analyze any original data, a 2018
analysis by the state of Wisconsin’s
Department of Employee Trust Funds
cited numerous studies finding that the
cost of coverage was minimal, and noted
that ‘‘[w]hile it is challenging to predict
the costs of care averted for any
condition, there is some evidence that
the costs associated with providing
transgender-inclusive plans is met with
reduced costs related to
comorbidities.’’ 708
Other studies looking at both public
and private sector plans have reached
similar conclusions. One study
published in the New England Journal
of Medicine projected that the cost for
providing gender-transition-related
health care benefits to members of the
military would result in an annual
increase of 0.012% of health care costs,
‘‘little more than a rounding error in the
military’s $47.8 billion annual health
704 Id. at p. 3. More recent estimates indicate that
a higher share of the population in the United
States identifies as transgender (0.6% of the U.S.
adult population), Andrew R. Flores et al., The
Williams Inst., UCLA Sch. of Law, Race and
Ethnicity of Adults Who Identify as Transgender in
the United States, p. 2 (2016), https://
williamsinstitute.law.ucla.edu/wp-content/uploads/
Race-Ethnicity-Trans-Adults-US-Oct-2016.pdf.
705 State of Cal., Dep’t of Ins., supra note 703, at
p. 8.
706 Id. at p. 9.
707 Id. at pp. 6–7.
708 State of Wis., Dep’t of Employee Trust Funds,
Correspondence Memorandum Re: Transgender
Services Coverage, p. 6–8 (Aug. 14, 2018), https://
etf.wi.gov/boards/groupinsurance/2018/08/22/
item6a1/download?inline=.
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care budget.’’ 709 A 2013 study of 34
public and private sector employers that
provided nondiscriminatory health care
coverage found that providing gendertransition-related benefits to treat
gender dysphoria had ‘‘zero to very low
costs.’’ 710 A study comparing costs and
potential savings associated with
covering gender-transition-related care
concluded that projected ‘‘additional
expenses hold good value for reducing
the risk of negative endpoints—HIV,
depression, suicidality, and drug abuse’’
and noted that ‘‘provider coverage was
cost-effective in 85% of
simulations.’’ 711 More recently, a 2021
survey of employers conducted by the
Human Rights Campaign noted that
most employers who covered gendertransition-related care reported only
‘‘marginal increases’’ in cost, on the
order of ‘‘a fraction of a decimal point
of cost calculations.’’ 712
In recent years, some courts hearing
challenges to coverage exclusions have
also considered issues of cost and
concluded that covering gendertransition-related care does not
significantly increase costs for plans. In
discussing the parties’ experts on the
issue of the cost, one court noted that,
‘‘[f]rom an actuarial perspective, there
appears to be no dispute that the cost of
coverage is immaterial.’’ 713 Another
court reviewing expert testimony called
any cost savings from excluding
coverage for gender-affirming care ‘‘both
practically and actuarially
immaterial.’’ 714
Based on the studies discussed above,
we estimate that providing transgender
709 Aaron Belkin, Caring for Our Transgender
Troops—The Negligible Cost of Transition-Related
Care, 373 New Eng. J. Med. 1089 (2015), https://
www.nejm.org/doi/pdf/10.1056/
NEJMp1509230?articleTools=true.
710 Jody Harman, The Williams Inst., UCLA Sch.
of Law, Cost and Benefits of Providing TransitionRelated Health Care Coverage in Employee Health
Benefits Plans: Findings from a Survey of
Employers, p. 2 (Sept. 2013), https://
williamsinstitute.law.ucla.edu/wp-content/uploads/
Herman-Cost-Benefit-of-Trans-Health-BenefitsSept-2013.pdf.
711 William V. Padula et al., Societal Implications
of Health Insurance Coverage for Medically
Necessary Services in the U.S. Transgender
Population: A Cost-Effectiveness Analysis, 31 J. of
Ged. Internal Med. 394 (2015),
712 Human Rights Campaign, Corporate Equality
Index 2021 (2021), https://reports.hrc.org/
corporate-equality-index-2021?_
ga=2.206988627.1166715317.1639876655819100514.1639876655.
713 Boyden v. Conlin, 341 F. Supp. 3d 979, 1000
(W.D. Wis. 2018).
714 Flack v. Wisconsin Dep’t of Health Servs., 395
F. Supp. 3d 1001, 1021 (W.D. Wis. 2019); see also
Kadel v. Folwell, No. 1:19–cv–00272, 2022 WL
2106270, at *22 (‘‘in comparison to the [Defendant
state health plan]’s billion-dollar cash balance and
saves each of the Plan’s 740,000 members about one
dollar each’’).
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47903
individuals nondiscriminatory
insurance coverage and treatment would
have a small impact on the overall cost
of care and on health insurance
premiums in terms of the percentage of
overall spending. The utilization rate of
newly covered services is likely to be
extremely low because the transgender
individuals represent a small minority
in the general population, because not
all transgender individuals will seek
medical care in the course of their
transition, and because most entities
will provide such care regardless of this
proposed rule (i.e., they will not
otherwise have engaged in prohibited
sex discrimination).715
As described in this section, the costs
associated with additional coverage of
services are likely to be small on a
percentage basis; however, when these
estimates are combined with measures
of overall health care spending, they
would likely result in incremental costs
that could be substantial. As an initial
estimate, we pair the Belkin (2015)
estimate of 0.012% of incremental
health care costs with $3,931.3 billion
in total health consumption
expenditures in calendar year 2020.716
Combining these yields our upperbound estimate of $472 million in
annual costs associated with additional
coverage. As a lower-bound estimate,
we adopt an assumption that these costs
will be fully offset by reductions in
spending on other medical care. This
lower bound of $0 is broadly consistent
with a cost-effectiveness analysis that
includes the probability of negative
incremental costs associated with
coverage.717 For our primary estimate,
we start with the midpoint of the lowerbound and upper-bound cost estimate of
about $236 million annually. We reduce
this figure by half to account for several
factors, such as some covered entities
already covering transition-related
services under the baseline scenario,
whether or not this is in response to an
existing requirement. This results in a
primary estimate of about $118 million
per year in incremental annual costs
associated with additional coverage
under the proposed rule, with a full
range of cost estimates including $0
million and $472 million.
715 State of Cal., Dep’t of Ins., supra note 703, at
pp. 2, 5.
716 U.S. Dep’t of Health & Human Servs., Ctrs. for
Medicare & Medicaid Servs., Table 1. National
Health Expenditures; Aggregate and Per Capita
Amounts, Annual Percent Change and Percent
Distribution: Selected Calendar Years 1960–2020,
https://www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/
NationalHealthExpendData/NHE-Fact-Sheet (last
modified Dec. 15, 2021, 4:06 p.m.).
717 Padula, supra note 711, at 399 fig. 2.
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c. Total Quantified Costs
Table 4 below presents the total costs
anticipated under the proposed rule for
which estimates have been developed.
For the purposes of this analysis, we
assume that the regulatory requirements
begin to take effect at the start of 2024.
In the first year under the proposed rule,
these costs include $774.5 million in
training and $60.1 million to revise
policies and procedures. For all years in
the analysis, we estimate recurring costs
of $39.2 million related to notices. We
estimate a first-year cost of $26.3
million related to documentation, with
ongoing costs in future years of $4.8
million. We also report a primary cost
estimate of $117.9 million associated
with expanded coverage of gendertransition-related care. The total costs in
year 1 amount to $1,018.1 million, with
ongoing costs of $424.9 million in
subsequent years. Table 3 reports these
costs by year, with all estimates
presented in millions of year-2020
dollars.
TABLE 3—PRIMARY ESTIMATE OF TOTAL ANNUAL COSTS
[$ millions, 2020 dollars]
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Cost element
2024
2025
2026
2027
2028
Training ..................................................
Policies and Procedures ........................
Notices ...................................................
Documentation .......................................
Expanded Coverage ..............................
$774.5
60.1
39.2
26.3
117.9
$258.2
0.0
39.2
9.6
117.9
$258.2
0.0
39.2
9.6
117.9
$258.2
0.0
39.2
9.6
117.9
$258.2
0.0
39.2
9.6
117.9
Total Costs ......................................
1,018.1
424.9
424.9
424.9
424.9
We also identify a cost related to
covered entities submitting a request for
an exemption based on Federal
conscience or religious freedom laws.
We model this potential cost associated
with exemption requests as the time
spent by covered entities to (a) assess
the need for an exemption; (b) write the
exemption request; and (c) submit the
exemption request to OCR. As an initial
calculation, we assume that this would
involve two (2) employees spending two
(2) hours each assessing the need for an
exemption and one employee spending
three (3) hours writing and submitting
the exemption request to OCR. We
further assume that legal personnel,
including lawyers and legal assistants,
would perform these functions. The
mean hourly wage for these occupations
is $63.02 per hour for each employee,
which we double to account for
overhead and other costs. We multiply
these factors together and estimate the
cost per exemption request of $882.28
($63.02 × 2 × 7).
OCR receives an average of 428
Section 1557 complaints per year,
covering all areas addressed under the
statute and regulations. We estimate that
about a quarter of these are sex
discrimination complaints and
anticipate that only a fraction of these
correspond to religiously affiliated
covered entities, and that not all of these
complaints would relate to provision or
coverage to which religiously affiliated
covered entities would have a religious
or conscience objection. As an initial
calculation, we estimate that OCR
would receive fewer than 27 exemption
requests (428 × 0.25 × 0.5 × 0.5), and
that these would result in costs to
covered entities of $23,601 (multiplying
the previous product by $882.28). We
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include these costs in our assessment of
the likely impacts of the proposed rule,
but do not itemize these costs in Table
3 as they represent a rounding error
compared to other costs we identify. We
request public comment on the
assumptions in this calculation.
The proposed rule would also
explicitly extend the requirements of
Section 1557 and other civil rights
statutes to entities that are enrolled in
Medicare Part B. We are currently
unable to quantify the number of
covered entities that are enrolled in Part
B but that receive no other forms of
Federal financial assistance. The 2016
Rule discussed several of the challenges
associated with estimating the number
of these entities. For example, the 2016
Rule notes that, ‘‘although we have data,
by program, for the number of
physicians receiving payment from each
program, there is no single,
unduplicated count of physicians across
multiple programs.’’ We tentatively
adopt the finding of the 2016 Rule that
almost all practicing physicians were
likely covered by the rule because they
accept Federal financial assistance from
sources other than Medicare Part B.718
We request comment and data on the
number of entities who are enrolled in
Medicare Part B but do not otherwise
receive any form of Federal financial
assistance.
2. Discussion of Benefits
Quantifying benefits for this proposed
rule presents significant challenges. One
notable challenge relates to attribution:
several sources of benefits discussed in
the preambles of the 2016 and 2020
Rules overlap with and may be
718 81
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attributable to prior existing civil rights
regulation, to the ACA rather than the
2016 and 2020 rulemakings that
implement Section 1557, or to
nondiscrimination policies based on
state law or institutional policies
prohibiting discrimination generally.
A second challenge relates to
identifying a quantitative relationship
between nondiscrimination policies and
important outcomes such as
improvements in public health
outcomes. For example, we anticipate
that this regulation would reduce the
incidence of providers refusing to treat
patients based on the patient’s gender
identity. This would result in fewer
instances of delayed or denied care,
which in turn would lead to reductions
in mortality and morbidity risks.
However, we are not able to estimate the
changes in the magnitude of these
discriminatory events that would be
attributable to the proposed rule, and
thus are unable to quantify or monetize
these health improvements. Similarly,
we anticipate that the proposed rule
will result in other sources of benefits
that we are unable to quantify. These
include a reduction in suicidal ideation
and attempts, improvements to mental
health, reductions in substance use, and
generally align with a discussion of the
economic impacts of a California
regulation relating to gender
nondiscrimination in health
insurance.719 In addition, the
prohibition on discrimination through
the use of clinical algorithms is also
likely to have a direct benefit on the
health of individuals who are suffering
from delayed or denied medical care
719 State of Cal., Dep’t of Ins., supra note 703, at
pp. 9–11.
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due to discriminatory clinical
algorithms, though we are unable to
quantify this benefit.
These challenges were not resolved in
the RIAs associated with the 2016 or
2020 Rules, which only qualitatively
reported benefits. We request
comments, including data and
quantitative estimates of health and
quality-of-life improvements
attributable to nondiscrimination
regulations, that could inform a
quantitative analysis, should the
Department finalize this proposed rule.
In addition to these health
improvements, we anticipate benefits to
covered entities from additional
regulatory clarity on how OCR will
enforce the ACA’s nondiscrimination
protections, particularly in light of
ongoing litigation related to the 2020
Rule, the Bostock decision, and the
Department’s Bostock Notification. The
training provisions represent one
mechanism by which the proposed rule
would reduce discriminatory events.
This would, in turn, reduce the number
of enforcement actions, representing a
potential cost-saving benefit for covered
entities. We also anticipate benefits to
covered entities from the establishment
of a grievance process, which would
reduce the number of complaints filed
with OCR, though this may be offset
somewhat from covered entities with
fewer than 15 employees referring
complaints to OCR in lieu of adopting
their own grievance procedure.
We also anticipate benefits to
individuals from reduced obstacles to
accessing health care, including fewer
language barriers and a reduction in
discriminatory behavior related to
sexual orientation and gender identity.
These benefits relate to individuals’
ability to access care and the quality of
care they receive. For example, the
provisions related to language access for
LEP individuals and accessibility for
individuals with disabilities could
reduce instances of negative outcomes,
including death, due to a lack of
understanding between patient and
doctor or between patient and
pharmacist, as well as lack of access to
services. We also anticipate that the
process by which individuals and
recipients may seek an exemption based
on Federal conscience and religious
freedom laws will result in benefits
from reduced litigation, which we do
not capture in the cost analysis.
3. Analysis of Regulatory Alternatives to
the Proposed Rule
The Department considered various
alternatives in the course of developing
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this regulation. The following are a
representative sample of some of those
various alternatives considered.
The Department analyzed several
regulatory alternatives to the proposed
rule related to the notice requirements.
The first alternative considered
retaining the 2020 Rule repeal of the
notices and taglines provisions. The
Department considered concerns raised
in response to the 2016 Rule notice and
tagline requirements, as well as
concerns raised in response to the
removal of those requirements in the
2020 Rule. Though the Department
acknowledges the burden placed on
covered entities through the 2016 Rule
notice requirements, the Department
believes the 2020 Rule did not
adequately consider the confusion and
uncertainty placed on individuals or the
unnecessary ambiguity that covered
entities face by the 2020 Rule’s repeal of
the notices and taglines provisions in
their entirety. As described earlier, we
estimate that these provisions under the
proposed rule would cost covered
entities, as an aggregate, $39.2 million
for each year. While excluding the
provisions relating to the notices would
reduce the cost of the proposed rule by
$39.2 million, the Department rejected
this option because it believes that the
proposed provisions strike an
appropriate balance between providing
greater access for beneficiaries and
consumers, while maximizing efficiency
and economics of scale for covered
entities.
The second alternative considered by
the Department would require covered
entities to provide notices only at their
first encounter with a beneficiary. For
this alternative, we adopt the quantity
and cost estimates associated with
eligibility and enrollment
communication included in Table 3
above. Under our primary cost scenario,
this policy alternative would result in
annual costs of notices of $0.5 million,
which is about $38.6 million lower than
the proposed rule. The Department
rejected this option however, because
this policy alternative, while posing a
significantly reduced burden on covered
entities, would be too narrow and
substantially reduce the information
available to beneficiaries, likely
resulting in beneficiaries not being
aware of their civil rights, including
whether they have experienced a
prohibited discriminatory practice by a
covered entity.
The third alternative considered by
the Department would require a more
expansive notice provision, extending
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the requirements to include pharmacyrelated notices. For this alternative, we
adopt the 2020 RIA estimate of 2.9
billion annual pharmacy-related notices.
This would result in $127.4 million in
costs per year, or an increase of $88.2
million compared to the proposed rule.
While this alternative related to notices
would increase the number of notices
available to beneficiaries, and therefore
increase beneficiaries’ opportunity to
receive information regarding
nondiscrimination and civil rights
protections, the Department believes
this alternative would neither address
nor remedy the burden placed on
covered entities through the 2016 Rule
notice requirements. For this reason, the
Department rejected this alternative.
Finally, the Department also
considered not including a process for
covered entities to submit a request for
a religious or conscience exemption. As
described in the cost section, we
estimate that this policy alternative
would reduce the quantified costs by
$23,601. Previous Departmental
rulemakings have indicated that this
policy alternative could also result in
providers with religious and conscience
objections leaving the profession, or
covered entities exiting the market. We
request comment on this potential
impact, including any data or studies
that provide quantitative evidence that
the Department’s May 10, 2021 Bostock
Notification ‘‘that the Office for Civil
Rights will interpret and enforce Section
1557 and Title IX’s prohibitions on
discrimination based on sex to include:
(1) discrimination on the basis of sexual
orientation; and (2) discrimination on
the basis of gender identity’’—or
subsequent actions consistent with the
Bostock Notification—have resulted in
impacts of this nature.
We have not quantified the benefits
associated with this information for the
proposed rule or for these policy
alternatives.
Table 4 reports the total costs of these
policy alternatives in present value and
annualized terms, adopting a 3% and
7% discount rate. Table 5 reports the
difference between the total cost of the
alternatives compared to the provisions
of the proposed rule, using the same
accounting methods and discount rates.
All estimates are presented in millions
of year-2020 dollars, using 2024 as the
base year for discounting.
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TABLE 4—TOTAL COST OF POLICY ALTERNATIVES CONSIDERED
[$ millions, 2020 dollars]
Present value
Annualized
Accounting method discount rate
3%
Proposed Rule .........................................................................
Alternative 1: No Notice Provision ...........................................
Alternative 2: Single Notice Provision .....................................
Alternative 3: Pharmacy-Related Notices ................................
7%
$2,521.7
2,342.2
2,344.7
2,925.9
3%
$2,296.4
2,135.8
2,138.0
2,658.3
7%
$550.6
511.4
512.0
638.9
$560.1
520.9
521.4
648.3
TABLE 5—COMPARISON OF ALTERNATIVES TO PROPOSED RULE
[$ millions, 2020 dollars]
Present Value
Annualized
Accounting method discount rate
3%
¥$179.5
¥177.0
404.1
Alternative 1: No Notice Provision ...........................................
Alternative 2: Single Notice Provision .....................................
Alternative 3: Pharmacy-related Notices .................................
The Department also considered
whether to require covered entities to
collect the self-identified race, ethnicity,
primary language (spoken and written),
sex, age, and disability status data for
participants, beneficiaries, enrollees,
and applicants in any health program or
activity. The Department believes,
however, that our current authorities
under Section 1557, Title VI, Section
504, Title IX, and the Age Act already
provide us sufficient ability to collect
these data.
B. Regulatory Flexibility Act—Initial
Small Entity Analysis
The Department has examined the
economic implications of this proposed
rule as required by the Regulatory
Flexibility Act. This analysis, as well as
other sections in this Regulatory Impact
Analysis, serves as the Initial Regulatory
Flexibility Analysis, as required under
the Regulatory Flexibility Act.
1. Description and Number of Affected
Small Entities
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The U.S. Small Business
Administration (SBA) maintains a Table
of Small Business Size Standards
Matched to North American Industry
Classification System Codes (NAICS).720
We replicate the SBA’s description of
this table:
‘‘This table lists small business size
standards matched to industries described in
the North American Industry Classification
System (NAICS), as modified by the Office of
Management and Budget, effective January 1,
2017. The latest NAICS codes are referred to
as NAICS 2017.
720 U.S.
Small Bus. Admin., Table of Size
Standards, (last updated May 2, 2022), https://
www.sba.gov/document/support--table-sizestandards.
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The size standards are for the most part
expressed in either millions of dollars (those
preceded by ‘‘$’’) or number of employees
(those without the ‘‘$’’). A size standard is
the largest that a concern can be and still
qualify as a small business for Federal
Government programs. For the most part, size
standards are the average annual receipts or
the average employment of a firm.’’
This initial small entity analysis
adopts a finding from the 2016 Final
Rule that almost all businesses under
the scope of the proposed rule are small
businesses. In that analysis, the total
small entities numbered 254,998, which
accounts for about 93% of the 275,002
covered entities under the proposed
rule. The covered entities not
considered small businesses include
about 10% of physician practices that
exceed the SBA size standard for
physicians (excluding mental health
specialists) (North American Industry
Classification System code 62111);
about 12% of pharmacies that exceed
the SBA size standard for pharmacy and
drug store firms (North American
Industry Classification System code
44611); health insurance issuers; and
local government entities.
2. Description of the Potential Impacts
of the Rule on Small Entities
The Department generally considers a
rule to have a significant impact on a
substantial number of small entities if it
has at least a 3% impact on revenue on
at least 5% of small entities. We
performed a threshold analysis to
determine whether the proposed rule is
likely to exceed these thresholds. As
described earlier in this analysis, we
estimate the total annualized costs of
the proposed rule would be about $551
million. Dividing these total costs by the
254,998 small entities gives a cost per
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entity of $2,159. This cost estimate
would only exceed the 3% ‘‘significant
impact’’ threshold on revenue for any
covered small businesses with revenue
below $71,978. We tentatively conclude
that very few small businesses covered
by the proposed rule have revenue
below $71,978, and that this number is
very likely to be smaller than the 5%
‘‘substantial number’’ threshold.
As an additional consideration, we
note that the costs of the proposed rule
are mostly proportional to the size of the
covered entity. For example, the costs
associated with training, which account
for more than 70% of the total costs of
the proposed rule, are proportional to
the number of employees receiving
training. In the main analysis, we
estimate an incremental impact of one
(1) hour per employee trained. The
opportunity cost of training each
employee represents 0.05% of a fulltime employee’s annual labor
productivity, assuming a full-time
employee works 2,087 hours per year.
This finding, that the cost of training
represents 0.05% of the share of
employees receiving training, is
constant across firm size.
Because the costs of the proposed rule
are small relative to the revenue of
covered entities, including covered
small entities, and because even the
smallest affected entities would be
unlikely to face a significant impact, we
propose to certify that the proposed rule
will not have a significant economic
impact on a substantial number of small
entities.
C. Executive Order 13132: Federalism
As required by E.O. 13132 on
Federalism, the Department has
examined the effects of provisions in the
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proposed regulation on the relationship
between the Federal Government and
the States. The Department has
concluded that the proposed regulation
has Federalism implications but
preempts State law only where the
exercise of State authority directly
conflicts with the exercise of Federal
authority under the Federal statute.
The proposed regulation attempts to
balance State autonomy with the
necessity to create a Federal benchmark
that will provide a uniform level of
nondiscrimination protection across the
country. The proposed regulation
restricts regulatory preemption of State
law to the minimum level necessary to
achieve the objectives of the underlying
Federal statute, Section 1557 of the
ACA.
It is recognized that the States
generally have laws that relate to
nondiscrimination against individuals
on a variety of bases. State laws
continue to be enforceable, unless they
prevent application of the proposed
rule. The proposed rule explicitly
provides that it is not to be construed
to supersede State or local laws that
provide additional protections against
discrimination on any basis articulated
under the regulation. Provisions of State
law relating to nondiscrimination that
are ‘‘more stringent’’ than the proposed
Federal regulatory requirements or
implementation specifications will
continue to be enforceable.
Section 3(b) of E.O. 13132 recognizes
that national action limiting the
policymaking discretion of States will
be imposed only where there is
constitutional and statutory authority
for the action and the national activity
is appropriate in light of the presence of
a problem of national significance.
Discrimination issues in relation to
health care are of national concern by
virtue of the scope of interstate health
commerce. The ACA’s provisions reflect
this position.
Section 3(d)(2) of E.O. 13132 requires
that where possible, the Federal
Government defer to the States to
establish standards. Title I of the ACA
authorized the Secretary to promulgate
regulations to implement Section 1557,
and we have done so accordingly.
Section 4(a) of E.O. 13132 expressly
contemplates preemption when there is
a conflict between exercising State and
Federal authority under a Federal
statute. Section 4(b) of the Executive
Order authorizes preemption of State
law in the Federal rule making context
when ‘‘the exercise of State authority
directly conflicts with the exercise of
Federal authority under the Federal
statute.’’ The approach in this regulation
is consistent with these standards in the
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Executive Order in superseding State
authority only when such authority is
inconsistent with standards established
pursuant to the grant of Federal
authority under the statute.
Section 6(b) of E.O. 13132 includes
some qualitative discussion of
substantial direct compliance costs that
State and local governments would
incur as a result of a proposed
regulation. We have determined that the
costs of the proposed rule would not
impose substantial direct compliance
costs on State or local governments. We
have considered the cost burden that
this proposed rule would impose on
State and local health care and benefit
programs, and estimate State and local
government costs will be in the order of
$5.7 million in the first two years of
implementation. The $1.9 million
represents the sum of the costs of
training State workers and enforcement
costs attributable to State agencies
analyzed above.
D. Executive Order 12250 on Leadership
and Coordination of Nondiscrimination
Laws
Pursuant to E.O. 12250, the Attorney
General has the responsibility to
‘‘review . . . proposed rules . . . of the
Executive agencies’’ implementing
nondiscrimination statutes such as
Section 1557 ‘‘in order to identify those
which are inadequate, unclear or
unnecessarily inconsistent.’’ 721 The
Attorney General has delegated that
function to the Assistant Attorney
General for the Civil Rights Division for
purposes of reviewing and approving
proposed rules, 28 CFR 0.51, and the
Assistant Attorney General has
reviewed and approved this proposed
rule.
E. Paperwork Reduction Act
This proposed rule contains
information collection requirements that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA).722 Under the PRA, agencies are
required to submit to OMB for review
and approval any reporting or recordkeeping requirements inherent in a
proposed or final rule and are required
to publish such proposed requirements
for public comment. The PRA requires
agencies to provide a 60-day notice in
the Federal Register and solicit public
comment on a proposed collection of
information before it is submitted to
OMB for review and approval. Section
3506(c)(2)(A) of the PRA requires that
721 E.O. 12250, sec. 1–202; 45 FR 72995 (Nov. 2,
1980).
722 44 U.S.C. 3501 et seq.
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the Department solicit comment on the
following issues:
1. Whether the information collection
is necessary and useful to carry out the
proper functions of the agency;
2. The accuracy of the agency’s
estimate of the information collection
burden;
3. The quality, utility, and clarity of
the information to be collected; and
4. Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
The PRA requires consideration of the
time, effort, and financial resources
necessary to meet the information
collection requirements referenced in
this section. The Department invites
public comment on its assumptions as
they relate to the PRA requirements
summarized in this section and
explicitly invites comment from
potential respondents regarding the
burden estimate we ascribe to these
requirements, including a discussion of
respondents’ basis for their
computation.
The collections of information
proposed by this Notice of Proposed
Rulemaking relate to § 92.5 (Assurances
required); § 92.7 (Designation and
responsibilities of a Section 1557
Coordinator); § 92.8 (Section 1557
Policies and Procedures); § 92.9
(Training); § 92.10 (Notice of
nondiscrimination); and § 92.11 (Notice
of availability of language assistance
services and auxiliary aids and
services). Respondents to this proposed
information collection would include a
variety of covered entities with a health
program or activity including hospitals,
ambulatory surgical centers, skilled
nursing facilities, and physicians’
offices. For a more detailed discussion
concerning the potential costs
implications related to these proposed
collections of information, please see
the Preliminary Economic Analysis of
Impacts directly below.
Proposed § 92.5 retains the assurances
obligation from the 2016 and 2020 Rules
for covered entities to submit an
assurance of compliance to the
Department. OCR has previously
obtained PRA approval (OMB control #
0945–0008) for this reporting
requirement via an updated HHS Form
690 (Consolidated Civil Rights
Assurance Form), separate from this
rulemaking. The requirement to sign
and submit an assurance of compliance
currently exists under Section 1557 and
other civil rights regulations (Title VI,
Section 504, Title IX, and the Age Act).
Since the Department provides an
online portal through which covered
entities submit an attestation of
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Assurance of Compliance, the
Department has determined that this
requirement imposes no additional
reporting or recordkeeping requirements
under the PRA.
Proposed § 92.7 requires covered
entities with 15 or more employees to
designate a Section 1557 Coordinator to
coordinate their efforts to comply with
and carry out their responsibilities
under Section 1557. The burden to
coordinate efforts to comply with and
carry out the responsibilities under
Section 1557 is estimated at an
annualized burden of 10 hours per
covered entity to store complaints and
the associated records required under
proposed § 92.8(c)(2) each year. We
assume that administrative or clerical
support personnel would perform these
functions. The mean hourly wage for
this occupation is $17.38 per hour. The
Department estimates the number of
covered entities with more than 15
employees to be approximately 15% or
41,250. We estimate the costs of
retaining records related to grievances
filed at all covered entities would be
$14.3 million annually ($17.38 × 2 × 10
× 41,250). This estimation approach will
overstate the costs if many covered
entities already retain complaint
information.
The burden for documenting
employee training as required under
proposed § 92.9(c) is the cost of covered
entity staff time to (a) create training
attendance forms; and (b) store the
training sign-up sheet. The labor cost
would include one (1) employee
spending 15 minutes (0.25 hours) to
create the sign-up sheet during the first
year and one (1) employee spending one
(1) hour collecting and storing the
attendance forms during the first year
and subsequent years. We estimate that
administrative or clerical support
personnel would perform these
functions. The mean hourly wage for
this occupation is $17.38 per hour. The
labor cost is $6.0 million in the first year
(($17.38 × 1.25) × 275,002 covered
entities). We estimate that the cost in
subsequent years would be $4.8 million,
which would represent an annual
allotment of one (1) hour (($17.38 × 1)
× 275,002 covered entities).
Proposed § 92.10 and § 92.11 require
covered entities to notify the public of
their nondiscrimination requirements,
as well as the availability of language
assistance services and auxiliary aids
and services.
Proposed § 92.10 requires covered
entities to provide a notice of
nondiscrimination relating to its health
programs or activities, to participants,
beneficiaries, enrollees, and applicants
of its health programs and activities,
and members of the public. To
minimize burden on covered entities,
the provision proposes a covered entity
may combine the content of the notice
required by this section with the notice
required by Title VI, Section 504, Title
IX, and the Age Act implementing
regulations.
Proposed § 92.11 requires covered
entities to notify the public of their
nondiscrimination requirements, as well
as availability of language assistance
services and auxiliary aids and services.
A covered entity must provide a notice
that, at minimum, states that the
covered entity provides language
assistance services and auxiliary aids
and services free of charge in its health
programs and activities, in compliance
with Section 1557. This notice must be
provided to participants, beneficiaries,
enrollees, and applicants of the covered
entity’s health program or activity, and
members of the public. The notice must
be provided in English and at least the
most common 15 languages spoken by
LEP individuals of the relevant state or
states and must be provided in alternate
formats for individuals with disabilities
who require auxiliary aids and services
to ensure effective communication.
Both types of notices are required (1)
on an annual basis; (2) upon request; (3)
at a conspicuous location on the
covered entity’s health program or
activity website; and (4) in clear and
conspicuous physical locations where
the health program or activity interacts
with the public.
The Department estimates the burden
for responding to the proposed notice
requirement would be 34 minutes and
that administrative or clerical support
personnel would perform these
functions. Because it is difficult to
determine the exact number of
communications which would be
required to contain the notices
anticipated under the proposed rule, our
cost estimates reflect a wide range of
uncertainty in the cost. The Department
estimates an adjusted annual primary
costs total of $4.5 million, with a range
of costs between $2.7 million and $25.0
million. These costs would occur in
each year of the time horizon of the
analysis.
TABLE 1—PROPOSED ANNUAL BURDEN OF RESPONSE IN YEAR ONE/SUBSEQUENT YEARS FOLLOWING PUBLICATION OF
THE FINAL RULE
Number of
responses per
respondent
Number of
respondents
Total
responses
Average
burden
per hours
response
Total annual
burden
(hours) 723
Regulation
burden
Type of respondent
§ 92.7 Coordination Efforts ............
724 41,250/275,002
1
316,252
725 10/1.25
756,252
§ 92.10 & § 92.11 Notice ...............
Covered entities with 15 or more
employees/all covered entities.
All covered entities .......................
275,002
726 1
275,002
34/60
93,501
Total Annual Burden Hours ....
.......................................................
....................................
........................
........................
........................
849,753
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* The figures in this column are averages based on a range. Small entities may require fewer hours to conduct certain compliance activities, while large entities may
require more hours than those provided here due to their size and complexity.
** We monetize the time spent on revising policies and procedures, depending on the extent of the revisions. For the 137,501 covered entities with less extensive
revisions, we estimate two (2) total hours spent on revisions per entity. For the 137,501 covered entities with more extensive revisions, we estimate four (4) total
hours spent on revision per entity.
723 The figures in this column are averages based
on a range. Small entities may require fewer hours
to conduct certain compliance activities, while
large entities may require more hours than those
provided here due to their size and complexity.
724 Covered entities with 15 or more employees
would be required to coordinate the retention of
grievance complaints for no less than three years.
We have estimated that this provision would apply
to approximately 41,250 covered entities. All
covered entities would be required to document
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employee training on Section 1557. We estimated
that this would apply to approximately 275,002
covered entities.
725 We have estimated that covered entities with
15 or more employees would spend approximately
10 hours on efforts to coordinate their compliance
efforts under Section 1557 as required under § 92.7.
We estimate that all covered entities would spend
approximately 1.25 hours documenting employee
training as required under § 92.9.
726 Because it is difficult to determine the exact
number of communications which would be
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required to contain the notices anticipated under
the proposed rule, our number of responses per
respondent estimate reflects this uncertainty. The
Department invites potential respondents to
comment on its assumption regarding number of
responses per respondent and the ultimate burden
estimate we ascribe to this requirement, including
a discussion of respondents’ basis for their
computation.
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*** Because it is difficult to determine the exact number of communications which would be required to contain the notices anticipated under the proposed rule, our
number of responses per respondent estimate reflects this uncertainty. The Department invites potential respondents to comment on its assumption regarding a number of responses per respondent and the ultimate burden estimate we ascribe to this requirement, including a discussion of respondents’ basis for their computation.
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VII. Request for Comment
The Department seeks comment on all
issues raised by the proposed
regulation. Specifically, in addition to
issues on which it has already requested
comments above, the Department
requests comment on:
• The financial impact of the
proposed rule on the health care sector,
with any detailed supporting
information, facts, surveys, audits, or
reports;
• Whether the application of this rule
to health programs and activities that
receive Federal funding, to health
programs and activities of executive
agencies, and to all programs and
activities of executive agencies should
be considered in a different manner;
• Whether, and if so how, the
proposed rule addresses clarity and
confusion over compliance
requirements and rights of people to be
free from discrimination on protected
bases;
• Whether covered entities that
employ fewer than 15 people should be
required to have a Section 1557
Coordinator and grievance procedures,
and any benefits and burdens associated
with such a requirement;
• Whether, and if so how, new and
developing technologies can assist
covered entities with their compliance
obligations and enhance access to
quality health care;
• The costs to provide the notice of
nondiscrimination and the Notice of
Availability and the impact of such
notices on the utilization of language
assistance services for LEP individuals
and auxiliary aids and services for
individuals with disabilities with any
detailed supporting information, facts,
surveys, audits, or reports;
• Whether the list of communications
that require a Notice of Availability
captures those most critical for LEP
individuals and individuals with
disabilities, and any detailed supporting
information, facts, surveys, audits, or
reports pertaining to the benefit of such
notices or the related cost of their
inclusion in the listed communications;
• Whether standards set pursuant to
Section 510 of the Rehabilitation Act on
ensuring the availability of accessible
medical diagnostic equipment, should
be incorporated as an enforceable
standard for covered entities into the
proposed rule for purposes of Section
1557;
• How best to address challenges
accessing accessible medical diagnostic
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equipment and whether lack of access to
such equipment constitutes
discriminatory benefit design or
network inadequacy;
• Whether Section 1557 should
include a provision requiring covered
entities to comply with specific
accessibility standards for web content
such as Section 508 standards, the
WCAG 2.0 standards, the WCAG 2.1
standards, or other standards that
provide equal or greater accessibility to
individuals with disabilities.
Additionally, OCR seeks comments on
whether to adopt a safe harbor provision
under which covered entities that are in
compliance with established specific
accessibility standards are deemed in
compliance with proposed § 92.204;
whether OCR should require covered
entities to comply with the most recent
edition of a published standard; and the
timeline necessary for covered entities
to come into compliance with a new
standard.
• What steps the Department can take
to assist covered entities in meeting
their language access and effective
communication responsibilities, such
that these services are provided in the
most efficient and effective manner for
participants, beneficiaries, enrollees,
and applicants of covered health
programs and activities.
• Unaddressed discrimination on the
basis of race, color, national origin
(including limited English proficiency
and primary language), sex (including
pregnancy, sexual orientation, gender
identity, and sex characteristics), age,
and disability as applied to State and
Federally-facilitated Exchanges, with
any detailed supporting information,
facts, surveys, audits, or reports; and
• Whether covered entities seek
guidance on best practices for
compliance with Section 1557, and on
what topics.
List of Subjects
42 CFR Part 438
Civil rights, Discrimination, Grant
programs—health, Individuals with
disabilities, Medicaid, National origin,
Nondiscrimination, Reporting and
recordkeeping requirements, Sex
discrimination.
42 CFR Part 440
Civil rights, Discrimination, Grant
programs—health, Individuals with
disabilities, Medicaid, National origin,
Nondiscrimination, Sex discrimination.
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42 CFR Part 457
Civil rights, Discrimination, Grant
programs—health, Individuals with
disabilities, Medicaid, National origin,
Nondiscrimination, Sex discrimination.
42 CFR Part 460
Age discrimination, Aged, Civil
rights, Discrimination, Health,
Individuals with disabilities, Medicare,
Medicaid, National origin,
Nondiscrimination, Religious
discrimination, Reporting and
recordkeeping requirements, Sex
discrimination.
45 CFR Part 80
Administrative practice and
procedure, Civil rights, Discrimination,
Medicare, Nondiscrimination.
45 CFR Part 84
Administrative practice and
procedure, Civil rights, Discrimination,
Individuals with disabilities, Medicare,
Nondiscrimination.
45 CFR Part 86
Administrative practice and
procedure, Civil rights, Discrimination,
Education, Medicare,
Nondiscrimination, Sex discrimination.
45 CFR Part 91
Administrative practice and
procedure, Civil rights, Discrimination,
Elderly, Medicare, Nondiscrimination.
45 CFR Part 92
Administrative practice and
procedure, Civil rights, Discrimination,
Elderly, Health care, Health facilities,
Health insurance, Health programs and
activities, Individuals with disabilities,
Medicare, Nondiscrimination, Reporting
and recordkeeping requirements, Sex
discrimination.
45 CFR Part 147
Aged, Citizenship and naturalization,
Civil rights, Health care, Health
insurance, Individuals with disabilities,
Intergovernmental relations, Reporting
and recordkeeping requirements, Sex
discrimination.
45 CFR Part 155
Administrative practice and
procedure, Advertising, Aged, Brokers,
Citizenship and naturalization, Civil
rights, Conflict of interests, Consumer
protection, Grant programs-health,
Grants administration, Health care,
Health insurance, Health maintenance
organizations (HMO), Health records,
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Hospitals, Indians, Individuals with
disabilities, Intergovernmental relations,
Loan programs-health, Medicaid,
Organization and functions
(Government agencies), Public
assistance programs, Reporting and
recordkeeping requirements, Sex
discrimination, State and local
governments, Taxes, Technical
assistance, Women, Youth.
45 CFR Part 156
Administrative practice and
procedure, Advertising, Advisory
committees, Brokers, Conflict of
interests, Consumer protection, Grant
programs-health, Grants administration,
Health care, Health insurance, Health
maintenance organization (HMO),
Health records, Hospitals, Indians,
Individuals with disabilities, Loan
programs-health, Medicaid,
Organization and functions
(Government agencies), Public
assistance programs, Reporting and
recordkeeping requirements, State and
local governments, Sunshine Act,
Technical assistance, Women, Youth.
For the reasons set forth in the
preamble, the Department of Health and
Human Services proposes to amend 42
CFR parts 438, 440, 457, and 460 and 45
CFR parts 80, 84, 92, 147, 155, and 156
as follows:
religion, sex (including sexual
orientation and gender identity), age,
mental or physical disability, or source
of payment.
*
*
*
*
*
■ 10. Amend § 460.112 by revising
paragraph (a) introductory text to read
as follows:
PART 440—SERVICES: GENERAL
PROVISIONS
§ 460.112 Specific rights to which a
participant is entitled.
4. The authority citation for part 440
continues to read as follows:
■
Authority: 42 U.S.C. 1302.
■
5. Revise § 440.262 to read as follows:
§ 440.262
Access and cultural conditions.
The State must have methods to
promote access and delivery of services
in a culturally competent manner to all
beneficiaries, including those with
limited English proficiency, diverse
cultural and ethnic backgrounds,
disabilities, and regardless of sex
(including sexual orientation and
gender identity). These methods must
ensure that beneficiaries have access to
covered services that are delivered in a
manner that meets their individualized
needs.
PART 457—ALLOTMENTS AND
GRANTS TO STATES
6. The authority citation for part 457
continues to read as follows:
■
Title 42—Public Health
PART 438—MANAGED CARE
Authority: Section 1102 of the Social
Security Act (42 U.S.C. 1302).
1. The authority citation for part 438
continues to read as follows:
■
7. Section 457.495 is amended by
adding paragraph (e) to read as follows:
■
Authority: 42 U.S.C. 1302.
2. Amend § 438.3 by revising
paragraph (d)(4) to read as follows:
§ 457.495 State assurance of access to
care and procedures to assure quality and
appropriateness of care.
§ 438.3
*
■
Standard contract requirements.
*
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to promote the delivery of services in a
culturally competent manner to all
enrollees, including those with limited
English proficiency and diverse cultural
and ethnic backgrounds, disabilities,
and regardless of sex (including sexual
orientation and gender identity).
*
*
*
*
*
*
*
*
*
(d) * * *
(4) The MCO, PIHP, PAHP, PCCM or
PCCM entity will not discriminate
against individuals eligible to enroll on
the basis of race, color, national origin,
sex (including sexual orientation and
gender identity), or disability and will
not use any policy or practice that has
the effect of discriminating on the basis
of race, color, national origin, sex
(sexual orientation and gender identity),
or disability.
*
*
*
*
*
■ 3. Amend § 438.206 by revising
paragraph (c)(2) to read as follows:
§ 438.206
Availability of services.
*
18:38 Aug 03, 2022
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PART 460—PROGRAMS OF ALLINCLUSIVE CARE FOR THE ELDERLY
(PACE)
8. The authority citation for part 460
continues to read as follows:
■
Authority: 42 U.S.C. 1302, 1395l,
1395eee(f), and 1396u–4(f).
9. Amend § 460.98 by revising
paragraph (b)(3) to read as follows:
■
§ 460.98
Service delivery.
*
*
*
*
*
(c) * * *
(2) Access and cultural
considerations. Each MCO, PIHP, and
PAHP participates in the State’s efforts
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*
*
*
*
(e) Access to and delivery of services
in a culturally competent manner to all
beneficiaries, as described in 42 CFR
440.262.
*
*
*
*
(b) * * *
(3) The PACE organization may not
discriminate against any participant in
the delivery of required PACE services
based on race, ethnicity, national origin,
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(a) Respect and nondiscrimination.
Each participant has the right to
considerate, respectful care from all
PACE employees and contractors at all
times and under all circumstances. Each
participant has the right not to be
discriminated against in the delivery of
required PACE services based on race,
ethnicity, national origin, religion, sex
(including sexual orientation and
gender identity), age, mental or physical
disability, or source of payment.
Specifically, each participant has the
right to the following:
*
*
*
*
*
Title 45—Public Health
PART 80—NONDISCRIMINATION
UNDER PROGRAMS RECEIVING
FEDERAL ASSISTANCE THROUGH
THE DEPARTMENT OF HEALTH AND
HUMAN SERVICES EFFECTUATION
OF TITLE VI OF THE CIVIL RIGHTS
ACT OF 1964
11. The authority citation for part 80
continues to read as follows:
■
Authority: Sec. 602, 78 Stat. 252; 42 U.S.C.
2000d–1.
12. Amend part 1 of appendix A to
part 80 by adding paragraph 155 to read
as follows:
■
Appendix A to Part 80—Federal
Financial Assistance to Which These
Regulations Apply
Part 1 * * *
155. Supplementary medical
insurance benefits for the aged (Title
XVIII, Part B, Social Security Act, 42
U.S.C. 1395j–1395w–6).
*
*
*
*
*
■
PART 84—NONDISCRIMINATION ON
THE BASIS OF HANDICAP IN
PROGRAMS OR ACTIVITIES
RECEIVING FEDERAL FINANCIAL
ASSISTANCE
13. The authority citation for part 84
continues to read as follows:
■
Authority: 20 U.S.C. 1405; 29 U.S.C. 794;
42 U.S.C. 290dd–2; 21 U.S.C. 1174.
Appendix A to Part 84 [Amended]
14. Amend appendix A to part 84
under subpart a by removing the third
■
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paragraph in ‘‘2. Federal financial
assistance’’.
■ 15. Revise part 92 to read as follows:
PART 92—NONDISCRIMINATION IN
HEALTH PROGRAMS OR ACTIVITIES
Subpart A—General Provisions
Sec.
92.1 Purpose and applicability date.
92.2 Application.
92.3 Relationship to other laws.
92.4 Definitions.
92.5 Assurances required.
92.6 Remedial action and voluntary action.
92.7 Designation and responsibilities of a
Section 1557 Coordinator.
92.8 Policies and procedures.
92.9 Training.
92.10 Notice of nondiscrimination.
92.11 Notice of availability of language
assistance services and auxiliary aids
and services.
Subpart B—Nondiscrimination Provisions
92.101 Discrimination prohibited.
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Subpart C—Specific Applications to Health
Programs and Activities.
92.201 Meaningful access for limited
English proficient individuals.
92.202 Effective communication for
individuals with disabilities.
92.203 Accessibility for buildings and
facilities.
92.204 Accessibility of information and
communication technology for
individuals with disabilities.
92.205 Requirement to make reasonable
modifications.
92.206 Equal program access on the basis
of sex.
92.207 Nondiscrimination in health
insurance and other health-related
coverage.
92.208 Prohibition on sex discrimination
related to marital, parental, or family
status.
92.209 Nondiscrimination on the basis of
association.
92.210 Nondiscrimination in the use of
clinical algorithms in decision-making.
92.211 Nondiscrimination in the delivery
of health programs and activities through
telehealth services.
Subpart D—Procedures
92.301 Enforcement mechanisms.
92.302 Notification of views regarding
application of Federal conscience and
religious freedom laws.
92.303 Procedures for health programs and
activities conducted by recipients and
State Exchanges.
92.304 Procedures for health programs and
activities administered by the
Department.
Authority: 42 U.S.C. 18116
Subpart A—General Provisions
§ 92.1
Purpose and applicability date.
(a) Purpose. The purpose of this part
is to implement Section 1557 of the
Patient Protection and Affordable Care
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Act (ACA) (42 U.S.C. 18116), which
prohibits discrimination on the basis of
race, color, national origin, sex, age, and
disability in certain health programs
and activities. Section 1557 provides
that, except as otherwise provided in
Title I of the ACA, an individual shall
not, on the grounds prohibited under
Title VI of the Civil Rights Act of 1964,
Title IX of the Education Amendments
of 1972, the Age Discrimination Act of
1975, or Section 504 of the
Rehabilitation Act of 1973, be excluded
from participation in, be denied the
benefits of, or be subjected to
discrimination under, any health
program or activity, any part of which
is receiving Federal financial assistance,
including credits, subsidies, or contracts
of insurance, or under any program or
activity that is administered by an
Executive Agency or any entity
established under Title I of the ACA.
This part applies to health programs or
activities administered by recipients of
Federal financial assistance from the
Department, Department-administered
health programs or activities, and Title
I entities that administer health
programs or activities.
(b) Applicability date. The regulations
in this part are applicable beginning
[DATE 60 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE],
except to the extent that provisions of
this part require changes to health
insurance or group health plan benefit
design (including covered benefits,
benefit limitations or restrictions, and
cost-sharing mechanisms, such as
coinsurance, copayments, and
deductibles); such provisions, as they
apply to health insurance or group
health plan benefit design, have an
applicability date of the first day of the
first plan year (in the individual market,
policy year) beginning on or after [DATE
ONE YEAR AFTER EFFECTIVE DATE
OF FINAL RULE].
§ 92.2
Application.
(a) Except as otherwise provided in
this part, this part shall apply to:
(1) Every health program or activity,
any part of which receives Federal
financial assistance, directly or
indirectly, from the Department;
(2) Every health program or activity
administered by the Department; and
(3) Every program or activity
administered by a Title I entity.
(b) The provisions of this part shall
not apply to any employer with regard
to its employment practices, including
the provision of employee health
benefits.
(c) Any provision of this part held to
be invalid or unenforceable by its terms,
or as applied to any person or
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circumstance, shall be severable from
this part and shall not affect the
remainder thereof or the application of
the provision to other persons not
similarly situated or to other, dissimilar
circumstances.
§ 92.3
Relationship to other laws.
(a) Neither section 1557 nor this part
shall be construed to apply a lesser
standard for the protection of
individuals from discrimination than
the standards applied under Title VI of
the Civil Rights Act of 1964, Title IX of
the Education Amendments of 1972,
Section 504 of the Rehabilitation Act of
1973, the Age Discrimination Act of
1975, or the regulations issued pursuant
to those laws.
(b) Nothing in this part shall be
construed to invalidate or limit the
rights, remedies, procedures, or legal
standards available under Title VI of the
Civil Rights Act of 1964, Title VII of the
Civil Rights Act of 1964, Title IX of the
Education Amendments of 1972,
Section 504 of the Rehabilitation Act of
1973, or the Age Discrimination Act of
1975.
(c) Nothing in this part shall be
construed to invalidate or limit the
rights, remedies, procedures, or legal
standards available to individuals under
Federal conscience or religious freedom
laws.
§ 92.4
Definitions.
As used in this part, the term—
1991 Standards means the 1991 ADA
Standards for Accessible Design,
published at Appendix A to 28 CFR part
36 on July 26, 1991, and republished as
Appendix D to 28 CFR part 36 on
September 15, 2010.
2010 Standards means the 2010 ADA
Standards for Accessible Design, as
defined at 28 CFR 35.104.
ACA means the Patient Protection and
Affordable Care Act (Pub. L. 111–148,
124 Stat. 119 (2010) as amended by the
Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152, 124 Stat. 1029) (codified in
scattered sections of U.S.C.)).
ADA means the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101
et seq.), as amended.
Age means how old a person is, or the
number of elapsed years from the date
of a person’s birth.
Age Act means the Age
Discrimination Act of 1975 (42 U.S.C.
6101 et seq.), as amended.
Applicant means a person who
applies to participate in a health
program or activity.
Auxiliary aids and services include,
for example:
(1) Qualified interpreters on-site or
through video remote interpreting (VRI)
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services, as defined in 28 CFR 35.104
and 36.303(b); note takers; real-time
computer-aided transcription services;
written materials; exchange of written
notes; telephone handset amplifiers;
assistive listening devices; assistive
listening systems; telephones
compatible with hearing aids; closed
caption decoders; open and closed
captioning, including real-time
captioning; voice, text, and video-based
telecommunications products and
systems, including text telephones
(TTYs), videophones, and captioned
telephones, or equally effective
telecommunications devices; videotext
displays; accessible information and
communication technology (ICT); or
other effective methods of making
aurally delivered information available
to persons who are deaf or hard of
hearing;
(2) Qualified readers; taped texts;
audio recordings; Braille materials and
displays; screen reader software;
magnification software; optical readers;
secondary auditory programs (SAP);
large print materials; accessible
information and communication
technology; or other effective methods
of making visually delivered materials
available to persons who are blind or
have low vision;
(3) Acquisition or modification of
equipment and devices; and
(4) Other similar services and actions.
Companion means a family member,
friend, or associate of an individual
seeking access to a service, program or
activity of a covered entity, who along
with such individual, is an appropriate
person with whom a covered entity
should communicate.
Covered entity means:
(1) A recipient of Federal financial
assistance;
(2) The Department; and
(3) An entity established under Title
I of the ACA.
Department means the U.S.
Department of Health and Human
Services.
Director means the Director of the
Office for Civil Rights (OCR) of the
Department, or their designee(s).
Disability means, with respect to a
person, a physical or mental impairment
that substantially limits one or more
major life activities of such person; a
record of such an impairment; or being
regarded as having such an impairment,
as defined and construed in the
Rehabilitation Act, 29 U.S.C. 705(9)(B),
which incorporates the definition of
disability in the ADA, 42 U.S.C. 12102,
as amended and adopted at 28 CFR
35.108.
Exchange means the same as
‘‘Exchange’’ defined in 45 CFR 155.20.
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Federal financial assistance. (1)
Federal financial assistance means any
grant, loan, credit, subsidy, contract
(other than a procurement contract but
including a contract of insurance), or
any other arrangement by which the
Federal Government, directly or
indirectly, provides assistance or
otherwise makes assistance available in
the form of:
(i) Funds;
(ii) Services of Federal personnel; or
(iii) Real or personal property or any
interest in or use of such property,
including:
(A) Transfers or leases of such
property for less than fair market value
or for reduced consideration; and
(B) Proceeds from a subsequent
transfer or lease of such property if the
Federal share of its fair market value is
not returned to the Federal Government.
(2) Federal financial assistance the
Department provides or otherwise
makes available includes Federal
financial assistance that the Department
plays a role in providing or
administering, including advance
payments of the premium tax credit and
cost-sharing reduction payments under
Title I of the ACA, as well as payments,
subsidies, or other funds extended by
the Department to any entity providing
health insurance coverage for payment
to or on behalf of a person obtaining
health insurance coverage from that
entity or extended by the Department
directly to such person for payment to
any entity providing health insurance
coverage.
Federally-facilitated Exchange means
the same as ‘‘Federally-facilitated
Exchange’’ defined in 45 CFR 155.20.
Health program or activity means:
(1) Any project, enterprise, venture, or
undertaking to
(i) Provide or administer healthrelated services, health insurance
coverage, or other health-related
coverage;
(ii) Provide assistance to persons in
obtaining health-related services, health
insurance coverage, or other healthrelated coverage;
(iii) Provide clinical, pharmaceutical,
or medical care;
(iv) Engage in health research; or
(v) Provide health education for
health care professionals or others;
(2) All of the operations of any entity
principally engaged in the provision or
administration of any health projects,
enterprises, ventures, or undertakings
described in paragraph (1) of this
definition, including, but not limited to,
a State or local health agency, hospital,
health clinic, health insurance issuer,
physician’s practice, pharmacy,
community-based health care provider,
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nursing facility, residential or
community-based treatment facility, or
other similar entity or combination
thereof.
Information and communication
technology (ICT) means information
technology and other equipment,
systems, technologies, or processes, for
which the principal function is the
creation, manipulation, storage, display,
receipt, or transmission of electronic
data and information, as well as any
associated content. Examples of ICT
include, but are not limited to:
computers and peripheral equipment;
information kiosks and transaction
machines; telecommunications
equipment; telehealth interfaces or
applications; customer premises
equipment; multifunction office
machines; software; mobile
applications; websites; videos; and
electronic documents.
Language assistance services may
include, but are not limited to:
(1) Oral language assistance,
including interpretation in non-English
languages provided in-person or
remotely by a qualified interpreter for a
limited English proficient individual,
and the use of qualified bilingual or
multilingual staff to communicate
directly with limited English proficient
individuals;
(2) Written translation, performed by
a qualified translator, of written content
in paper or electronic form into or from
languages other than English; and
(3) Written notice of availability of
language assistance services.
Limited English proficient individual
means an individual whose primary
language for communication is not
English and who has a limited ability to
read, write, speak, or understand
English. A limited English proficient
individual may be competent in English
for certain types of communication (e.g.,
speaking or understanding), but still be
limited English proficient for other
purposes (e.g., reading or writing).
Machine translation means automated
translations, without the assistance of or
review by a qualified human translator,
that is text-based and provides instant
translations between various languages,
sometimes with an option for audio
input or output.
National origin includes, but is not
limited to, a person’s, or their
ancestor’s, place of origin (such as
country or world region) or a person’s
manifestation of the physical, cultural,
or linguistic characteristics of a national
origin group.
OCR means the Office for Civil Rights
of the Department.
Qualified bilingual/multilingual staff
means a member of a covered entity’s
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workforce who is designated by the
covered entity to provide in-language
oral language assistance as part of the
person’s current, assigned job
responsibilities and who has
demonstrated to the covered entity that
they are:
(1) Proficient in speaking and
understanding both spoken English and
at least one other spoken language,
including any necessary specialized
vocabulary, terminology and
phraseology; and
(2) Able to effectively, accurately, and
impartially communicate directly with
limited English proficient individuals in
their primary languages.
Qualified individual with a disability
means an individual with a disability
who, with or without reasonable
modifications to rules, policies, or
practices, the removal of architectural,
communication, or transportation
barriers, or the provision of auxiliary
aids and services, meets the essential
eligibility requirements for the receipt of
services or the participation in programs
or activities provided by the covered
entity.
Qualified interpreter for an individual
with a disability means an interpreter
who, via a video remote interpreting
service (VRI) or an on-site appearance,
is able to interpret effectively,
accurately, and impartially, both
receptively and expressively, using any
necessary specialized vocabulary.
Qualified interpreters include, for
example, sign language interpreters, oral
transliterators, and cued-language
transliterators.
Qualified interpreter for a limited
English proficient individual means an
interpreter who via a remote
interpreting service or an on-site
appearance:
(1) Has demonstrated proficiency in
speaking and understanding both
spoken English and at least one other
spoken language;
(2) Is able to interpret effectively,
accurately, and impartially to and from
such language(s) and English, using any
necessary specialized vocabulary or
terms without changes, omissions, or
additions and while preserving the tone,
sentiment, and emotional level of the
original oral statement; and
(3) Adheres to generally accepted
interpreter ethics principles, including
client confidentiality.
Qualified reader means a person who
is able to read effectively, accurately,
and impartially using any necessary
specialized vocabulary.
Qualified translator means a
translator who:
(1) Has demonstrated proficiency in
writing and understanding both written
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English and at least one other written
non-English language;
(2) Is able to translate effectively,
accurately, and impartially to and from
such language(s) and English, using any
necessary specialized vocabulary or
terms without changes, omissions, or
additions and while preserving the tone,
sentiment, and emotional level of the
original written statement; and
(3) Adheres to generally accepted
translator ethics principles, including
client confidentiality.
Recipient means any State or its
political subdivision thereof; or any
instrumentality of a State or political
subdivision thereof; any public or
private agency, institution, or
organization, or other entity, or any
person, to whom Federal financial
assistance is extended directly or
indirectly, including any subunit,
successor, assignee, or transferee of a
recipient. Such term does not include
any ultimate beneficiary.
Section 504 means Section 504 of the
Rehabilitation Act of 1973 (Pub. L. 93–
112; 29 U.S.C. 794), as amended.
Section 1557 means Section 1557 of
the ACA (42 U.S.C. 18116).
State Exchange means an Exchange
established by a State and approved by
the Department pursuant to 45 CFR part
155, subpart B.
Title I entity means any entity
established under Title I of the ACA, as
amended, including State Exchanges
and Federally-facilitated Exchanges.
Title VI means Title VI of the Civil
Rights Act of 1964 (Pub. L. 88–352; 42
U.S.C. 2000d et seq.), as amended.
Title VII means Title VII of the Civil
Rights Act of 1964 (Pub. L. 88–352; 42
U.S.C. 2000e et seq.), as amended.
Title IX means Title IX of the
Education Amendments of 1972 (Pub. L.
92–318; 20 U.S.C. 1681 et seq.), as
amended.
§ 92.5
Assurances required.
(a) Assurances. An entity applying for
Federal financial assistance to which
this part applies must, as a condition of
any application for Federal financial
assistance, submit an assurance, on a
form specified by the Director, that the
entity’s health programs and activities
will be operated in compliance with
Section 1557 and this part. A health
insurance issuer seeking certification to
participate in an Exchange or a State
seeking approval to operate a State
Exchange to which Section 1557 or this
part applies must, as a condition of
certification or approval, submit an
assurance, on a form specified by the
Director, that the health insurance
issuer’s or State’s health program or
activity will be operated in compliance
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47913
with Section 1557 and this part. An
applicant or entity may incorporate this
assurance by reference in subsequent
applications to the Department for
Federal financial assistance or requests
for certification to participate in an
Exchange or approval to operate a State
Exchange.
(b) Duration of obligation. The
duration of the assurances required by
this section is the same as the duration
of the assurances required in the
Department’s regulations implementing
Section 504, 45 CFR 84.5(b).
(c) Covenants. When Federal financial
assistance is provided in the form of real
property or interest, the same conditions
apply as those contained in the
Department’s regulations implementing
Section 504, at 45 CFR 84.5(c), except
that the nondiscrimination obligation
applies to discrimination on all bases
covered under Section 1557 and this
part.
§ 92.6 Remedial action and voluntary
action.
(a) Remedial action. (1) If the Director
finds that a recipient or State Exchange
has discriminated against an individual
on the basis of race, color, national
origin, sex, age, or disability, in
violation of Section 1557 or this part,
such recipient or State Exchange must
take such remedial action as the
Director may require to overcome the
effects of the discrimination.
(2) Where a recipient is found to have
discriminated against an individual on
the basis of race, color, national origin,
sex, age, or disability, in violation of
Section 1557 or this part, and where
another recipient exercises control over
the recipient that has discriminated, the
Director, where appropriate, may
require either or both entities to take
remedial action.
(3) The Director may, where necessary
to overcome the effects of
discrimination in violation of Section
1557 or this part, require a recipient, in
its health programs and activities, or
State Exchange to take remedial action
with respect to:
(i) Persons who are no longer
participants in the recipient’s or State
Exchange’s health program or activity
but who were participants in the health
program or activity when such
discrimination occurred; or
(ii) Persons who would have been
participants in the health program or
activity had the discrimination not
occurred.
(b) Voluntary action. A covered entity
may take nondiscriminatory steps, in
addition to any action that is required
by Section 1557 or this part, to
overcome the effects of conditions that
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result or resulted in limited
participation in the covered entity’s
health programs or activities by persons
on the basis of race, color, national
origin, sex, age, or disability.
§ 92.7 Designation and responsibilities of
a Section 1557 Coordinator.
(a) Section 1557 Coordinator and
designees. A covered entity that
employs fifteen or more persons must
designate and authorize at least one
employee, referred to herein as ‘‘Section
1557 Coordinator,’’ to coordinate the
covered entity’s compliance with its
responsibilities under Section 1557 and
this part in its health programs and
activities, including the investigation of
any grievance communicated to it
alleging noncompliance with Section
1557 or this part or alleging any action
that would be prohibited by Section
1557 or this part. As appropriate, a
covered entity may assign one or more
designees to carry out some of these
responsibilities, but the Section 1557
Coordinator must retain ultimate
oversight for ensuring coordination with
the covered entity’s compliance with
this part.
(b) Responsibilities of a Section 1557
Coordinator. A covered entity must
ensure that, at minimum, the Section
1557 Coordinator:
(1) Receives, reviews, and processes
grievances, filed under the grievance
procedure as set forth in § 92.8(c);
(2) Coordinates the covered entity’s
recordkeeping requirements as set forth
in § 92.8(c);
(3) Coordinates effective
implementation of the covered entity’s
language access procedures as set forth
in § 92.8(d);
(4) Coordinates effective
implementation of the covered entity’s
effective communication procedures as
set forth in § 92.8(e);
(5) Coordinates effective
implementation of the covered entity’s
reasonable modification procedures as
set forth in § 92.8(f); and
(6) Coordinates training of relevant
employees as set forth in § 92.9 of this
part, including maintaining
documentation required by such
section.
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§ 92.8
Policies and procedures.
(a) General requirement. A covered
entity must implement written policies
and procedures in its health programs
and activities that are designed to
comply with the requirements of this
part. The policies and procedures must
include an effective date and be
reasonably designed, taking into
account the size, complexity, and the
type of health programs or activities
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undertaken by a covered entity, to
ensure compliance with this part.
(b) Nondiscrimination policy. A
covered entity must implement a
written policy in its health programs
and activities that, at minimum, states
the covered entity does not discriminate
on the basis of race, color, national
origin (including limited English
proficiency and primary language), sex
(including pregnancy, sexual
orientation, gender identity, and sex
characteristics), age, or disability; that
the covered entity provides language
assistance services and appropriate
auxiliary aids and services free of
charge, when necessary for compliance
with Section 1557 or this part; that the
covered entity will provide reasonable
modifications for individuals with
disabilities; and provides the contact
information for the Section 1557
Coordinator required by § 92.7 (if
applicable).
(c) Grievance procedures. (1) A
covered entity that employs fifteen or
more persons must implement written
grievance procedures in its health
programs and activities that provide for
the prompt and equitable resolution of
grievances alleging any action that
would be prohibited by Section 1557 or
this part.
(2) A covered entity to which this
paragraph applies must retain records
related to grievances filed with it that
allege discrimination on the basis of
race, color, national origin, sex, age, or
disability for no less than three (3)
calendar years from the date of the filing
of the grievance. The records must
include the grievance; the name and
contact information of the complainant
(if provided by complainant); the
alleged discriminatory action and
alleged basis (or bases) of
discrimination; the date the grievance
was filed; grievance resolution; and any
other pertinent information.
(3) A covered entity to which this
paragraph applies must keep
confidential the identity of an
individual who has filed a grievance
under this part except as required by
law or to the extent necessary to carry
out the purposes of this part, including
the conduct of any investigation.
(d) Language access procedures. A
covered entity must implement written
language access procedures in its health
programs and activities describing the
covered entity’s process for providing
language assistance services to limited
English proficient individuals when
required under § 92.201 of this part. At
a minimum, the language access
procedures must include current
information detailing the contact
information for the Section 1557
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Coordinator (if applicable); how an
employee identifies whether an
individual is limited English proficient;
how an employee obtains the services of
qualified interpreters and translators the
covered entity uses to communicate
with a limited English proficient
individual; the names of any qualified
bilingual staff members; and a list and
the location of any electronic and
written translated materials the covered
entity has and the languages they are
translated into, and the publication
date.
(e) Effective communication
procedures. A covered entity must
implement written effective
communication procedures in its health
programs and activities describing the
covered entity’s process for ensuring
effective communication for individuals
with disabilities when required under
§ 92.202. At a minimum, a covered
entity’s effective communication
procedures must include current contact
information for the Section 1557
Coordinator (if applicable); how an
employee obtains the services of
qualified interpreters the covered entity
uses to communicate with individuals
with disabilities, including the names of
any qualified interpreter staff members,
and how to access appropriate auxiliary
aids and services.
(f) Reasonable modification
procedures. A covered entity must
implement written procedures in its
health programs and activities
describing its process for making
reasonable modifications to its policies,
practices, or procedures when necessary
to avoid discrimination on the basis of
disability as required under § 92.205. At
a minimum, the reasonable modification
procedures must include contact
information for the covered entity’s
Section 1557 Coordinator (if applicable);
a description of the covered entity’s
process for responding to requests from
individuals with disabilities for
changes, exceptions, or adjustments to a
rule, policy, practice, or service of the
covered entity; and a process for
determining whether making the
modification would fundamentally alter
the nature of the health program or
activity, including identifying an
alternative modification that does not
result in a fundamental alteration to
ensure the individual with a disability
receives the benefits or services in
question.
(g) Combined policies and
procedures. A covered entity may
combine the content of the policies and
procedures required by paragraphs (b)
through (f) of this section with any
policies and procedures pursuant to
Title VI, Section 504, Title IX, and the
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Age Act if Section 1557 and the
provisions in this part are clearly
addressed therein.
§ 92.9
Training.
(a) A covered entity must train
relevant employees of its health
programs and activities on the civil
rights policies and procedures required
by § 92.8, as necessary and appropriate
for the employees to carry out their
functions within the covered entity
consistent with the requirements of this
part.
(b) A covered entity must provide
training that meets the requirements of
paragraph (a) of this section, as follows:
(1) To each relevant employee of the
health program or activity as soon as
possible, but no later than [DATE ONE
YEAR AFTER EFFECTIVE DATE OF
FINAL RULE];
(2) Thereafter, to each new relevant
employee of the health program or
activity within a reasonable period of
time after the employee joins the
covered entity’s workforce; and
(3) To each relevant employee of the
health program or activity whose
functions are affected by a material
change in the policies or procedures
required by § 92.8 of this part and any
other civil rights policies or procedures
the covered entity has implemented
within a reasonable period of time after
the material change has been made.
(c) A covered entity must
contemporaneously document its
employees’ completion of the training
required by paragraphs (a) and (b) of
this section in written or electronic form
and maintain said documentation for no
less than three (3) calendar years.
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§ 92.10
Notice of nondiscrimination.
(a) A covered entity must provide a
notice of nondiscrimination to
participants, beneficiaries, enrollees,
and applicants of its health programs
and activities, and members of the
public.
(1) The notice required under this
paragraph (a) must include the
following information relating to its
health programs and activities:
(i) The covered entity does not
discriminate on the basis of race, color,
national origin (including limited
English proficiency and primary
language), sex (including pregnancy,
sexual orientation, gender identity, and
sex characteristics), age, or disability;
(ii) The covered entity provides
reasonable modifications for individuals
with disabilities, and appropriate
auxiliary aids and services, including
qualified interpreters for individuals
with disabilities and information in
alternate formats, such as braille or large
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print, free of charge and in a timely
manner, when such modifications, aids,
and services are necessary to ensure
accessibility and an equal opportunity
to participate to individuals with
disabilities;
(iii) The covered entity provides
language assistance services, including
electronic and written translated
documents and oral interpretation free
of charge and in a timely manner, when
such services are necessary to provide
meaningful access to a limited English
proficient individual;
(iv) How to obtain from the covered
entity the reasonable modifications,
appropriate auxiliary aids and services,
and language assistance services in
paragraphs (a)(1)(ii) and (iii) of this
section;
(v) The contact information for the
covered entity’s Section 1557
Coordinator designated pursuant to
§ 92.7 of this part (if applicable);
(vi) The availability of the covered
entity’s grievance procedure pursuant to
§ 92.8(c) of this part and how to file a
grievance (if applicable);
(vii) Details on how to file a
discrimination complaint with OCR in
the Department; and
(viii) How to access the covered
entity’s website, if it has one, that
provides the information required under
paragraph (a)(1) of this section.
(2) The notice must be provided in a
covered entity’s health program or
activity, as follows:
(i) On an annual basis to participants,
beneficiaries, enrollees (including late
and special enrollees), and applicants of
its health program or activity;
(ii) Upon request;
(iii) At a conspicuous location on the
covered entity’s health program or
activity website, if it has one; and
(iv) In clear and prominent physical
locations where it is reasonable to
expect individuals seeking service from
the health program or activity to be able
to read or hear the notice.
(b) A covered entity may combine the
content of the notice required by
paragraph (a) of this section with the
notices required by 45 CFR 80.6(d),
84.8, 86.9, and 91.32 if the combined
notice clearly informs individuals of
their civil rights under Section 1557 and
this part, so long as it includes each of
the elements required by paragraph
(a)(1) of this section.
§ 92.11 Notice of availability of language
assistance services and auxiliary aids and
services.
(a) A covered entity must provide a
notice of availability of language
assistance services and auxiliary aids
and services that, at minimum, states
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that the covered entity, in its health
programs or activities, provides
language assistance services and
appropriate auxiliary aids and services
free of charge, when necessary for
compliance with Section 1557 or this
part, to participants, beneficiaries,
enrollees, and applicants of its health
program or activities, and members of
the public.
(b) This notice of availability of
language assistance services and
auxiliary aids and services must be
provided in English and at least the 15
languages most commonly spoken by
limited English proficient individuals of
the relevant state or states and must be
provided in alternate formats for
individuals with disabilities who
require auxiliary aids and services to
ensure effective communication.
(c) The notice required under
paragraph (a) of this section must be
provided in a covered entity’s health
program or activity, as follows:
(1) On an annual basis to participants,
beneficiaries, enrollees (including late
and special enrollees), and applicants of
its health program or activity;
(2) Upon request;
(3) At a conspicuous location on the
covered entity’s health program or
activity website, if it has one;
(4) In clear and prominent physical
locations where it is reasonable to
expect individuals seeking service from
the health program or activity to be able
to read or hear the notice; and
(5) In the following electronic and
written communications when these
forms are provided by a covered entity:
(i) Notice of nondiscrimination
required by § 92.10;
(ii) Notice of privacy practices
required by 45 CFR 164.520;
(iii) Application and intake forms;
(iv) Notices of denial or termination of
eligibility, benefits or services,
including Explanations of Benefits, and
notices of appeal and grievance rights;
(v) Communications related to a
person’s rights, eligibility, benefits, or
services that require or request a
response from a participant, beneficiary,
enrollee, or applicant;
(vi) Communications related to a
public health emergency;
(vii) Consent forms and instructions
related to medical procedures or
operations, medical power of attorney,
or living will (with an option of
providing only one notice for all
documents bundled together);
(viii) Discharge papers;
(ix) Complaint forms; and
(x) Patient and member handbooks.
(d) A covered entity shall be deemed
in compliance with this section with
respect to an individual if it exercises
the option to:
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(1) On an annual basis, provide the
individual with the option to opt out of
receipt of the notice required by this
section in their primary language and
through any appropriate auxiliary aids
and services, and:
(i) Does not condition the receipt of
any aid or benefit on the individual’s
decision to opt out;
(ii) Informs the individual that they
have a right to receive the notice upon
request in their primary language and
through the appropriate auxiliary aids
and services;
(iii) Informs the individual that opting
out of receiving the notice is not a
waiver of their right to receive language
assistance services and any appropriate
auxiliary aids and services as required
by this part;
(iv) Documents, on an annual basis,
that the individual has opted out of
receiving the notice required by this
section for that year; and
(v) Does not treat a non-response from
an individual as a decision to opt out;
or
(2) Document the individual’s
primary language and any appropriate
auxiliary aids and services and:
(i) Provides all materials and
communications in that individual’s
primary language and through any
appropriate auxiliary aids and services;
or
(ii) Provides the notice required by
paragraph (a) of this section in that
individual’s primary language and
through any appropriate auxiliary aids
and services in all communications that
are identified in paragraph (c)(5) of this
section.
prohibitions on discrimination in the
Department’s implementing regulations
for Title VI, Section 504, Title IX, and
the Age Act, found at parts 80, 84, 86
(subparts C and D), and 91 (subpart B)
of this subchapter, respectively. Where
this paragraph cross-references
regulatory provisions that use the term
‘‘recipient,’’ the term ‘‘recipient or State
Exchange’’ shall apply in its place.
Where this paragraph cross-references
regulatory provisions that use the term
‘‘student,’’ ‘‘employee,’’ or ‘‘applicant,’’
these terms shall be replaced with
‘‘individual.’’
(ii) The Department, including
Federally-facilitated Exchanges, must
comply with specific prohibitions on
discrimination in the Department’s
implementing regulations for Title VI,
Section 504, Title IX, and the Age Act,
found at parts 80, 85, 86 (subparts C and
D), and 91 (subpart B) of this
subchapter, respectively. Where this
paragraph cross-references regulatory
provisions that use the term ‘‘a
recipient,’’ the term ‘‘the Department or
a Federally-facilitated Exchange’’ shall
apply in its place. Where this paragraph
cross-references regulatory provisions
that use the term ‘‘student,’’
‘‘employee,’’ or ‘‘applicant,’’ these terms
shall be replaced with ‘‘individual.’’
(2) The enumeration of specific
prohibitions on discrimination in
paragraph (b)(1) of this section does not
limit the general applicability of the
prohibition in paragraph (a) of this
section.
Subpart B—Nondiscrimination
Provisions
§ 92.201 Meaningful access for limited
English proficient individuals.
§ 92.101
(a) General requirement. A covered
entity must take reasonable steps to
provide meaningful access to each
limited English proficient individual
eligible to be served or likely to be
directly affected by its health programs
and activities.
(b) Language assistance services
requirements. Language assistance
services required under paragraph (a) of
this section must be provided free of
charge, be accurate and timely, and
protect the privacy and the independent
decision-making ability of the limited
English proficient individual.
(c) Specific requirements for
interpreter and translation services. (1)
When interpretation services are
required under this part, a covered
entity must offer a qualified interpreter
in its health programs and activities.
(2) When translation services are
required under this part, a covered
Discrimination prohibited.
(a) General. (1) Except as provided in
Title I of the ACA, an individual must
not, on the basis of race, color, national
origin, sex, age, or disability, be
excluded from participation in, be
denied the benefits of, or otherwise be
subjected to discrimination under any
health program or activity operated by
a covered entity.
(2) Discrimination on the basis of sex
includes, but is not limited to,
discrimination on the basis of sex
stereotypes; sex characteristics,
including intersex traits; pregnancy or
related conditions; sexual orientation;
and gender identity.
(b) Specific prohibitions on
discrimination. (1) In any health
program or activity to which this part
applies:
(i) A recipient and State Exchange
must comply with the specific
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entity must use a qualified translator in
its health programs and activities.
(3) If a covered entity uses machine
translation when the underlying text is
critical to the rights, benefits, or
meaningful access of a limited English
proficient individual, when accuracy is
essential, or when the source documents
or materials contain complex, nonliteral or technical language, the
translation must be reviewed by a
qualified human translator.
(d) Evaluation of compliance. In
evaluating whether a covered entity has
met its obligation under paragraph (a) of
this section, the Director shall:
(1) Evaluate, and give substantial
weight to, the nature and importance of
the health program or activity and the
particular communication at issue, to
the limited English proficient
individual; and
(2) Take into account other relevant
factors, including the effectiveness of
the covered entity’s written language
access procedures for its health
programs and activities, that the covered
entity has implemented pursuant to
§ 92.8(d).
(e) Restricted use of certain persons to
interpret or facilitate communication. A
covered entity must not, in its health
programs and activities:
(1) Require a limited English
proficient individual to provide their
own interpreter, or to pay the cost of
their own interpreter;
(2) Rely on an adult, not qualified as
an interpreter, accompanying a limited
English proficient individual to
interpret or facilitate communication,
except:
(i) As a temporary measure, while
finding a qualified interpreter in an
emergency involving an imminent
threat to the safety or welfare of an
individual or the public where there is
no qualified interpreter for the limited
English proficient individual
immediately available and the qualified
interpreter that arrives confirms or
supplements the initial communications
with the accompanying adult; or
(ii) Where the limited English
proficient individual specifically
requests that the accompanying adult
interpret or facilitate communication,
the accompanying adult agrees to
provide such assistance, the request and
agreement by the accompanying adult is
documented, and reliance on that adult
for such assistance is appropriate under
the circumstances.
(3) Rely on a minor child to interpret
or facilitate communication, except as a
temporary measure while finding a
qualified interpreter in an emergency
involving an imminent threat to the
safety or welfare of an individual or the
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public where there is no qualified
interpreter for the limited English
proficient individual immediately
available and the qualified interpreter
that arrives confirms or supplements the
initial communications with the minor
child; or
(4) Rely on staff other than qualified
interpreters, qualified translators, or
qualified bilingual/multilingual staff to
communicate directly with limited
English proficient individuals.
(f) Video remote interpreting services.
A covered entity that provides a
qualified interpreter for a limited
English proficient individual through
video remote interpreting services in the
covered entity’s health programs and
activities must provide:
(1) Real-time full-motion video and
audio over a dedicated high-speed,
wide-bandwidth video connection or
wireless connection that delivers high
quality video images that do not
produce lags, choppy, blurry, or grainy
images, or irregular pauses in
communication;
(2) A sharply delineated image that is
large enough to display the interpreter’s
face and the participating person’s face
regardless of the person’s body position;
(3) A clear, audible transmission of
voices; and
(4) Adequate training to users of the
technology and other involved persons
so that they may quickly and efficiently
set up and operate the video remote
interpreting.
(g) Audio remote interpreting services.
A covered entity that provides a
qualified interpreter for a limited
English proficient individual through
audio remote interpreting services in the
covered entity’s health programs and
activities must provide:
(1) Real-time audio over a dedicated
high-speed, wide-bandwidth connection
or wireless connection that delivers
high-quality audio without lags or
irregular pauses in communication;
(2) A clear, audible transmission of
voices; and
(3) Adequate training to users of the
technology and other involved persons
so that they may quickly and efficiently
set up and operate the remote
interpreting services.
(h) Acceptance of language assistance
services is not required. Nothing in this
section shall be construed to require a
limited English proficient individual to
accept language assistance services.
§ 92.202 Effective communication for
individuals with disabilities.
(a) A covered entity must take
appropriate steps to ensure that
communications with individuals with
disabilities (including companions with
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disabilities), are as effective as
communications with non-disabled
individuals in its health programs and
activities, in accordance with the
standards found at 28 CFR 35.130 and
28 CFR 35.160 through 35.164. Where
the regulatory provisions referenced in
this section use the term ‘‘public
entity,’’ the term ‘‘covered entity’’ shall
apply in its place.
(b) A covered entity must provide
appropriate auxiliary aids and services
to individuals with impaired sensory,
manual, or speaking skills, where
necessary to afford such individuals an
equal opportunity to benefit from the
service in question.
CFR 84.23(a) and (b) with respect to
those facilities, if the construction or
alteration was commenced on or before
July 18, 2016. Each facility or part of a
facility in which health programs or
activities are conducted that is
constructed or altered by or on behalf of,
or for the use of, a recipient or State
Exchange in conformance with UFAS
shall be deemed to comply with the
requirements of this section and with 45
CFR 84.23(a) and (b), if the construction
was commenced on or before July 18,
2016, and such facility was not covered
by the 1991 Standards or 2010
Standards.
§ 92.203 Accessibility for buildings and
facilities.
§ 92.204 Accessibility of information and
communication technology for individuals
with disabilities.
(a) No qualified individual with a
disability shall, because a covered
entity’s facilities are inaccessible to or
unusable by individuals with
disabilities, be denied the benefits of, be
excluded from participation in, or
otherwise be subjected to discrimination
under any health program or activity to
which this part applies.
(b) Each facility or part of a facility in
which health programs or activities are
conducted that is constructed or altered
by or on behalf of, or for the use of, a
recipient or State Exchange must
comply with the 2010 Standards if the
construction or alteration was
commenced on or after July 18, 2016,
except that if a facility or part of a
facility in which health programs or
activities are conducted that is
constructed or altered by or on behalf of,
or for the use of, a recipient or State
Exchange, was not covered by the 2010
Standards prior to July 18, 2016, such
facility or part of a facility must comply
with the 2010 Standards if the
construction was commenced after
January 18, 2018. Departures from
particular technical and scoping
requirements by the use of other
methods are permitted where
substantially equivalent or greater
access to and usability of the facility is
provided. All newly constructed or
altered buildings or facilities subject to
this section must comply with the
requirements for a ‘‘public building or
facility’’ as defined in section 106.5 of
the 2010 Standards.
(c) Each facility or part of a facility in
which health programs or activities
under this part are conducted that is
constructed or altered by or on behalf of,
or for the use of, a recipient or State
Exchange in conformance with the 1991
Standards at appendix D to 28 CFR part
36 or the 2010 Standards shall be
deemed to comply with the
requirements of this section and with 45
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(a) A covered entity must ensure that
its health programs and activities
provided through information and
communication technology are
accessible to individuals with
disabilities, unless doing so would
result in undue financial and
administrative burdens or a
fundamental alteration in the nature of
the health programs or activities. If an
action required to comply with this
section would result in such an
alteration or such burdens, a covered
entity shall take any other action that
would not result in such an alteration or
such burdens but would nevertheless
ensure that, to the maximum extent
possible, individuals with disabilities
receive the benefits or services of the
health program or activity provided by
the covered entity.
(b) A recipient or State Exchange shall
ensure that its health programs and
activities provided through websites
and mobile applications comply with
the requirements of Section 504 of the
Rehabilitation Act, as interpreted
consistent with Title II of the ADA (42
U.S.C. 12131 through 12165).
§ 92.205 Requirement to make reasonable
modifications.
A covered entity must make
reasonable modifications to policies,
practices, or procedures in its health
programs and activities when such
modifications are necessary to avoid
discrimination on the basis of disability,
unless the covered entity can
demonstrate that making the
modifications would fundamentally
alter the nature of the health program or
activity. For the purposes of this
section, the term ‘‘reasonable
modifications’’ shall be interpreted in a
manner consistent with the term as set
forth in the ADA Title II regulation at 28
CFR 35.130(b)(7).
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§ 92.206 Equal program access on the
basis of sex.
(a) A covered entity must provide
individuals equal access to its health
programs and activities without
discriminating on the basis of sex.
(b) In providing access to health
programs and activities, a covered entity
must not:
(1) Deny or limit health services,
including those that are offered
exclusively to individuals of one sex, to
an individual based upon the
individual’s sex assigned at birth,
gender identity, or gender otherwise
recorded;
(2) Deny or limit a health care
professional’s ability to provide health
services on the basis of an individual’s
sex assigned at birth, gender identity, or
gender otherwise recorded if such
denial or limitation has the effect of
excluding individuals from
participation in, denying them the
benefits of, or otherwise subjecting them
to discrimination on the basis of sex
under a covered health program or
activity;
(3) Adopt or apply any policy or
practice of treating individuals
differently or separating them on the
basis of sex in a manner that subjects
any individual to more than de minimis
harm, including by adopting a policy or
engaging in a practice that prevents an
individual from participating in a health
program or activity consistent with the
individual’s gender identity; or
(4) Deny or limit health services
sought for purpose of gender transition
or other gender-affirming care that the
covered entity would provide to an
individual for other purposes if the
denial or limitation is based on a
patient’s sex assigned at birth, gender
identity, or gender otherwise recorded.
(c) Nothing in this section requires the
provision of any health service where
the covered entity has a legitimate,
nondiscriminatory reason for denying or
limiting that service, including where
the covered entity typically declines to
provide the health service to any
individual or where the covered entity
reasonably determines that such health
service is not clinically appropriate for
a particular individual. However, a
provider’s belief that gender transition
or other gender-affirming care can never
be beneficial for such individuals (or its
compliance with a state or local law that
reflects a similar judgment) is not a
sufficient basis for a judgment that a
health service is not clinically
appropriate.
(d) The enumeration of specific forms
of discrimination in paragraph (b) of
this section does not limit the general
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applicability of the prohibition in
paragraph (a) of this section.
applicability of the prohibition in
paragraph (a) of this section.
§ 92.207 Nondiscrimination in health
insurance and other health-related
coverage.
§ 92.208 Prohibition on sex discrimination
related to marital, parental, or family status.
(a) A covered entity must not, in
providing or administering health
insurance coverage or other healthrelated coverage, discriminate on the
basis of race, color, national origin, sex,
age, or disability.
(b) A covered entity must not, in
providing or administering health
insurance coverage or other healthrelated coverage:
(1) Deny, cancel, limit, or refuse to
issue or renew health insurance
coverage or other health-coverage, or
deny or limit coverage of a claim, or
impose additional cost sharing or other
limitations or restrictions on coverage,
on the basis of race, color, national
origin, sex, age, or disability;
(2) Have or implement marketing
practices or benefit designs that
discriminate on the basis of race, color,
national origin, sex, age, or disability in
health insurance coverage or other
health-related coverage;
(3) Deny or limit coverage, deny or
limit coverage of a claim, or impose
additional cost sharing or other
limitations or restrictions on coverage,
to an individual based upon the
individual’s sex at birth, gender
identity, or gender otherwise recorded;
(4) Have or implement a categorical
coverage exclusion or limitation for all
health services related to gender
transition or other gender-affirming
care;
(5) Otherwise deny or limit coverage,
deny or limit coverage of a claim, or
impose additional cost sharing or other
limitations or restrictions on coverage,
for specific health services related to
gender transition or other genderaffirming care if such denial, limitation,
or restriction results in discrimination
on the basis of sex; or
(6) Have or implement benefit designs
that do not provide or administer health
insurance coverage or other healthrelated coverage in the most integrated
setting appropriate to the needs of
qualified individuals with disabilities.
(c) Nothing in this section requires
coverage of any health service where the
covered entity has a legitimate,
nondiscriminatory reason for
determining that such health service
fails to meet applicable coverage
requirements, such as medical necessity
requirements, in an individual case.
(d) The enumeration of specific forms
of discrimination in paragraph (b) of
this section does not limit the general
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In determining whether an individual
satisfies any policy or criterion
regarding access to its health programs
or activities, a covered entity must not
take an individual’s sex into account in
applying any rule concerning an
individual’s current, perceived,
potential, or past marital, parental, or
family status.
§ 92.209 Nondiscrimination on the basis of
association.
A covered entity must not exclude
from participation in, deny the benefits
of, or otherwise discriminate against an
individual in its health programs and
activities on the basis of the respective
race, color, national origin, sex, age, or
disability of the individual and another
person with whom the individual has a
relationship or association.
§ 92.210 Nondiscrimination in the use of
clinical algorithms in decision-making.
A covered entity must not
discriminate on the basis of race, color,
national origin, sex, age, or disability in
its health programs and activities
through the use of clinical algorithms in
its decision-making.
§ 92.211 Nondiscrimination in the delivery
of health programs and activities through
telehealth services.
A covered entity must not, in delivery
of its health programs and activities
through telehealth services,
discriminate on the basis of race, color,
national origin, sex, age, or disability.
Subpart D—Procedures
§ 92.301
Enforcement mechanisms.
The enforcement mechanisms
available for and provided under Title
VI of the Civil Rights Act of 1964, Title
IX of the Education Amendments of
1972, Section 504 of the Rehabilitation
Act of 1973, and the Age Discrimination
Act of 1975 shall apply for purposes of
Section 1557 as implemented by this
part.
§ 92.302 Notification of views regarding
application of Federal conscience and
religious freedom laws.
(a) A recipient may notify OCR of the
recipient’s view that it is exempt from
certain provisions of this part due to the
application of a Federal conscience or
religious freedom law.
(b) Once OCR receives such
notification from a particular recipient,
OCR shall promptly consider those
views in responding to any complaints
or otherwise determining whether to
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proceed with any investigation or
enforcement activity regarding that
recipient’s compliance with the relevant
provisions of this part. Any relevant
ongoing investigation or enforcement
activity regarding the recipient shall be
held in abeyance until a determination
has been made under paragraph (c) of
this section.
(c) Based on the information provided
in the notification under paragraph (a)
of this section, OCR may determine at
any time whether a recipient is exempt
from the application of certain
provisions of this part, or whether
modified application of the provision is
required as applied to specific contexts,
procedures, or health care services,
based on a Federal conscience or
religious freedom law. OCR will assess
whether there is a sufficiently concrete
factual basis for making a determination
and will apply the applicable legal
standards of the relevant law. OCR will
communicate its determination to the
recipient.
(d) If OCR determines that a recipient
is exempt from the application of
certain provisions of this part or
modified application of certain
provisions is required as applied to
specific contexts, procedures, or health
care services, based on a Federal
conscience or religious freedom law,
that determination does not otherwise
limit the application of any other
provision of this part to the recipient or
to other contexts, procedures, or health
care services.
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§ 92.303 Procedures for health programs
and activities conducted by recipients and
State Exchanges.
(a) The procedural provisions
applicable to title VI apply with respect
to administrative enforcement actions
concerning discrimination on the basis
of race, color, national origin, sex, and
disability discrimination under Section
1557 or this part. These procedures are
found at 45 CFR 80.6 through 80.11 and
part 81 of this subchapter.
(b) The procedural provisions
applicable to the Age Act apply with
respect to administrative enforcement
actions concerning age discrimination
under Section 1557 or this part. These
procedures are found at 45 CFR 91.41
through 91.50.
(c) When a recipient fails to provide
OCR with requested information in a
timely, complete, and accurate manner,
OCR may, after attempting to reach
voluntary resolution, find
noncompliance with Section 1557 and
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initiate appropriate enforcement
procedures, found at 45 CFR 80.8,
including beginning the process for
fund suspension or termination and
taking other action authorized by law.
§ 92.304 Procedures for health programs
and activities administered by the
Department.
(a) This section applies to
discrimination on the basis of race,
color, national origin, sex, age, or
disability in health programs and
activities administered by the
Department, including the Federallyfacilitated Exchanges.
(b) The procedural provisions
applicable to Section 504 at 45 CFR
85.61 through 85.62 shall apply with
respect to administrative enforcement
actions against the Department
concerning discrimination on the basis
of race, color, national origin, sex, age,
or disability under Section 1557 or this
part. Where this section cross-references
regulatory provisions that use the term
‘‘handicap,’’ the term ‘‘race, color,
national origin, sex, age, or disability’’
shall apply in its place.
(c) The Department must permit
access by OCR to its books, records,
accounts, other sources of information,
and facilities as may be pertinent to
ascertain compliance with Section 1557
or this part. Where any information
required of the Department is in the
exclusive possession of any other
agency, institution or person, and the
other agency, institution or person fails
or refuses to furnish this information,
the Department shall so certify and shall
set forth what efforts it has made to
obtain the information. Asserted
considerations of privacy or
confidentiality may not operate to bar
OCR from evaluating or seeking to
enforce compliance with Section 1557
or this part. Information of a
confidential nature obtained in
connection with compliance evaluation
or enforcement shall not be disclosed
except where necessary under the law.
(d) The Department must not
intimidate, threaten, coerce, retaliate, or
otherwise discriminate against any
individual or entity for the purpose of
interfering with any right or privilege
secured by Section 1557 or this part, or
because such individual or entity has
made a complaint, testified, assisted, or
participated in any manner in an
investigation, proceeding or hearing
under Section 1557 or this part. The
identity of complainants must be kept
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confidential by OCR in accordance with
applicable Federal law.
PART 147—HEALTH INSURANCE
REFORM REQUIREMENTS FOR THE
GROUP AND INDIVIDUAL HEALTH
INSURANCE MARKETS
16. The authority citation for part 147
continues to read as follows:
■
Authority: 42 U.S.C. 300gg through 300gg–
63, 300gg–91, and 300gg–92, 300gg–111
through 300gg–139, as amended, and section
3203, Pub. L. 116–136, 134 Stat. 281.
§ 147.104
[Amended]
17. Amend § 147.104 in paragraph (e)
by removing the term ‘‘sex’’ and adding
in its place the phrase ‘‘sex (including
sexual orientation and gender
identity)’’.
■
PART 155—EXCHANGE
ESTABLISHMENT STANDARDS AND
OTHER RELATED STANDARDS
UNDER THE AFFORDABLE CARE ACT
18.The authority citation for part 155
is amended to read as follows:
■
Authority: 42 U.S.C. 18021–18024, 18031–
18033, 18041–18042, 18051, 18054, 18071,
18081–18083, and 18116.
§ 155.120
[Amended]
19. Amend § 155.120 in paragraph
(c)(1)(ii) by removing the term ‘‘sex’’
and adding in its place the phrase ‘‘sex
(including sexual orientation and
gender identity)’’.
■
§ 155.220
[Amended]
20. Amend § 155.220 in paragraph
(j)(2)(i) by removing the term ‘‘sex’’ and
adding in its place the phrase ‘‘sex
(including sexual orientation and
gender identity)’’.
■
PART 156—HEALTH INSURANCE
ISSUER STANDARDS UNDER THE
AFFORDABLE CARE ACT, INCLUDING
STANDARDS RELATED TO
EXCHANGES
21. The authority citation for part 156
is amended to read as follows:
■
Authority: 42 U.S.C. 18021–18024, 18031–
18032, 18041–18042, 18044, 18054, 18061,
18063, 18071, 18082, 18116, and 26 U.S.C.
36B.
§ 156.200
[Amended]
22. Amend § 156.200 in paragraph (e)
by removing the term ‘‘sex’’ and adding
in its place the phrase ‘‘sex (including
sexual orientation and gender
identity)’’.
■
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[Amended]
23. Amend § 156.1230 in paragraph
(b)(2) by removing the term ‘‘sex’’ and
adding in its place the phrase ‘‘sex
■
(including sexual orientation and
gender identity)’’.
Dated: July 25, 2022.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2022–16217 Filed 7–28–22; 4:15 pm]
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Agencies
[Federal Register Volume 87, Number 149 (Thursday, August 4, 2022)]
[Proposed Rules]
[Pages 47824-47920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16217]
[[Page 47823]]
Vol. 87
Thursday,
No. 149
August 4, 2022
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
Office of the Secretary
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42 CFR Parts 438, 440, et al.
45 CFR Parts 80, 84, 86, et al.
Nondiscrimination in Health Programs and Activities; Proposed Rule
Federal Register / Vol. 87 , No. 149 / Thursday, August 4, 2022 /
Proposed Rules
[[Page 47824]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 438, 440, 457, and 460
Office of the Secretary
45 CFR Parts 80, 84, 86, 91, 92, 147, 155, and 156
[Docket ID: HHS-OS-2022-0012]
RIN: 0945-AA17
Nondiscrimination in Health Programs and Activities
AGENCY: Centers for Medicare and Medicaid Services; Office for Civil
Rights (OCR), Office of the Secretary, HHS.
ACTION: Notice of proposed rulemaking; notice of Tribal consultation.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS or the
Department) is issuing this proposed rule on Section 1557 of the
Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits
discrimination on the basis of race, color, national origin, sex, age,
or disability in certain health programs and activities. Section
1557(c) of the ACA authorizes the Secretary of the Department to
promulgate regulations to implement the nondiscrimination requirements
of Section 1557. The Department is also proposing to revise its
interpretation regarding whether Medicare Part B constitutes Federal
financial assistance for purposes of civil rights enforcement and to
revise nondiscrimination provisions to prohibit discrimination on the
basis of sexual orientation and gender identity in regulations issued
by the Centers for Medicare & Medicaid Services (CMS) governing
Medicaid and the Children's Health Insurance Program (CHIP); Programs
of All-Inclusive Care for the Elderly (PACE); health insurance issuers
and their officials, employees, agents, and representatives; States and
the Exchanges carrying out Exchange requirements; agents, brokers, or
web-brokers that assist with or facilitate enrollment of qualified
individuals, qualified employers, or qualified employees; issuers
providing essential health benefits; and qualified health plan issuers.
DATES:
Comments: Submit comments on or before October 3, 2022.
Meeting: Pursuant to Executive Order 13175, Consultation and
Coordination with Indian Tribal Governments, the Department of Health
and Human Services' Tribal Consultation Policy, and the Department's
Plan for Implementing Executive Order 13175, the Office for Civil
Rights solicits input by tribal officials as we develop the
implementing regulations for Section 1557 of the Affordable Care Act at
45 CFR part 92. The Tribal consultation meeting will be held on August
31, 2022, from 2 p.m. to 4 p.m. Eastern Daylight Time.
ADDRESSES: You may submit comments, identified by RIN Number 0945-AA17,
by any of the following methods. Please do not submit duplicate
comments.
To participate in the Tribal consultation meeting, you must
register in advance at https://www.zoomgov.com/meeting/register/vJIsfu-rqzksEl2T8gUp_lDrWBqkU0223CY.
Federal Rulemaking Portal: You may submit electronic comments at
https://www.regulations.gov by searching for the Docket ID number HHS-
OS-2022-0012. Follow the instructions for submitting electronic
comments. If you are submitting comments electronically, the Department
strongly encourages you to submit any comments or attachments in
Microsoft Word format. If you must submit a comment in Adobe Portable
Document Format (PDF), the Department strongly encourages you to
convert the PDF to ``print-to-PDF'' format, or to use some other
commonly used searchable text format. Please do not submit the PDF in a
scanned format. Using a print-to-PDF format allows the Department to
electronically search and copy certain portions of your submissions to
assist in the rulemaking process.
Regular, Express, or Overnight Mail: You may mail written comments
to the following address only: U.S. Department of Health and Human
Services, Office for Civil Rights, Attention: 1557 NPRM (RIN 0945-
AA17), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue
SW, Washington, DC 20201.
All comments received by the methods and due date specified above
may be posted without change to content to https://www.regulations.gov,
which may include personal information provided about the commenter,
and such posting may occur after the closing of the comment period.
However, the Department may redact certain non-substantive content from
comments before posting, including threats, hate speech, profanity,
graphic images, or individually identifiable information about a third-
party individual other than the commenter. In addition, comments or
material designated as confidential or not to be disclosed to the
public will not be accepted. Comments may be redacted or rejected as
described above without notice to the commenter, and the Department
will not consider in rulemaking any redacted or rejected content that
would not be made available to the public as part of the administrative
record.
Because of the large number of public comments normally received on
Federal Register documents, OCR is not able to provide individual
acknowledgments of receipt.
Please allow sufficient time for mailed comments to be received
timely in the event of delivery or security delays.
Please note that comments submitted by fax or email and those
submitted after the comment period will not be accepted.
Docket: For complete access to background documents or posted
comments, go to https://www.regulations.gov and search for Docket ID
number HHS-OS-2022-0012.
FOR FURTHER INFORMATION CONTACT:
Office for Civil Rights
Dylan Nicole de Kervor, (202) 240-3110 or (800) 537-7697 (TDD), or
via email at hhs.gov">[email protected]hhs.gov, for matters related to Section 1557.
Centers for Medicare & Medicaid Services
John Giles, (410) 786-5545, for matters related to Medicaid.
Emily King, 410-786-8537, for matters related to CHIP.
Timothy Roe, (410) 786-2006 for matters related to Programs of All-
Inclusive Care for the Elderly.
Becca Bucchieri, (301) 492-4341, Agata Pelka, (667) 290-9979, or Leigha
Basini, (301) 492-4380, for matters related to 45 CFR 155.120, 155.220,
156.125, 156.200, and 156.1230.
Lindsey Murtagh, (301) 492-4106, for matters related to 45 CFR 147.104.
Hannah Katch, (202) 578-9581, for general questions related to CMS
amendments.
Assistance to Individuals With Disabilities in Reviewing the
Rulemaking Record: Upon request, the Department will provide an
accommodation or auxiliary aid to an individual with a disability who
needs assistance to review the comments or other documents in the
public rulemaking record for the proposed regulations. To schedule an
appointment for this type of accommodation or auxiliary aid, please
[[Page 47825]]
call (202) 240-3110 or (800) 537-7697 (TDD) for assistance or email
hhs.gov">[email protected]hhs.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Nondiscrimination in Health Programs and Activities
A. Section 1557 Background and Rulemaking
B. Summary of the Proposed Rule
II. Reasons for the Proposed Rulemaking
A. The Scope of the 2020 Rule Is Not the Best Reading of the
Affordable Care Act and Section 1557's Statutory Text
B. The 2020 Rule's Preamble Does Not Reflect Recent Developments
in Sex Discrimination Law
C. The 2020 Rule Causes Unnecessary Confusion in Compliance
D. Proposed Changes Are Consistent With the Statute and Will
Further the Intended Purpose of the Statute
III. Nondiscrimination in Health Programs and Activities
Subpart A--General Provisions
Purpose and Effective Date (Sec. 92.1)
Application (Sec. 92.2)
Relationship to Other Laws (Sec. 92.3)
Definitions (Sec. 92.4)
Assurances Required (Sec. 92.5)
Remedial Action and Voluntary Action (Sec. 92.6)
Designation and Responsibilities of a Section 1557 Coordinator
(Sec. 92.7)
Policies and Procedures (Sec. 92.8)
Training (Sec. 92.9)
Notice of Nondiscrimination (Sec. 92.10)
Notice of Availability of Language Assistance Services and
Auxiliary Aids and Services (Sec. 92.11)
Subpart B--Nondiscrimination Provisions
Discrimination Prohibited (Sec. 92.101)
Subpart C--Specific Applications to Health Programs and
Activities
Meaningful Access for Limited English Proficient Individuals
(Sec. 92.201)
Effective Communication for Individuals With Disabilities (Sec.
92.202)
Accessibility for Buildings and Facilities (Sec. 92.203)
Accessibility of Information and Communication Technology for
Individuals With Disabilities (Sec. 92.204)
Requirement To Make Reasonable Modifications (Sec. 92.205)
Equal Program Access on the Basis of Sex (Sec. 92.206)
Nondiscrimination in Health Insurance Coverage and Other Health-
Related Coverage (Sec. 92.207)
Prohibition on Sex Discrimination Related to Marital, Parental,
or Family Status (Sec. 92.208)
Nondiscrimination on the Basis of Association (Sec. 92.209)
Use of Clinical Algorithms in Decision-Making (Sec. 92.210)
Nondiscrimination in the Delivery of Health Programs and
Activities Through Telehealth Services (Sec. 92.211)
Subpart D--Procedures
Enforcement Mechanisms (Sec. 92.301)
Notification of Views Regarding Application of Federal
Conscience and Religious Freedom Laws (Sec. 92.302)
Procedures for Health Programs and Activities Conducted by
Recipients and State Exchanges (Sec. 92.303)
Procedures for Health Programs and Activities Administered by
the Department (Sec. 92.304)
IV. Change in Interpretation--Medicare Part B Meets the Definition
of Federal Financial Assistance
V. CMS Amendments
A. Medicaid and Children's Health Insurance Program (CHIP)
B. Programs of All-Inclusive Care for the Elderly (PACE)
C. Insurance Exchanges and Group and Individual Health Insurance
Markets
VI. Executive Order 12866 and Related Executive Orders on Regulatory
Review
A. Regulatory Impact Analysis
B. Regulatory Flexibility Act--Initial Small Entity Analysis
C. Executive Order 13132: Federalism
D. Executive Order 12250 on Leadership and Coordination of
Nondiscrimination Laws
VII. Request for Comment
I. Background
A. Section 1557 Background and Rulemaking
In 2010, Congress passed and the President signed into law the
Patient Protection and Affordable Care Act (ACA) \1\ to reform the
country's health insurance system, making health care more affordable
and accessible for tens of millions of persons in the United States.
Among other things, the ACA provided health care access to many
individuals by increasing coverage options and prohibiting
discrimination in health care. Section 1557 of the ACA (Section 1557)
is one of the government's most powerful tools to ensure access to and
coverage of health care in a nondiscriminatory manner. Except as
otherwise provided in Title I of the ACA, Section 1557 prohibits
discrimination on the basis of race, color, national origin, sex, age,
or disability in a health program or activity, any part of which is
receiving Federal financial assistance, including credits, subsidies,
or contracts of insurance. Section 1557 also prohibits discrimination
on the basis of race, color, national origin, sex, age, or disability
under any program or activity that is administered by an Executive
Agency, or any entity established under Title I of the ACA or its
amendments. The statute cites Title VI of the Civil Rights Act of 1964
\2\ (Title VI), Title IX of the Education Amendments of 1972 \3\ (Title
IX), the Age Discrimination Act of 1975 \4\ (Age Act), and Section 504
of the Rehabilitation Act of 1973 \5\ (Section 504) to identify the
grounds of discrimination prohibited by Section 1557. The statute
further specifies that the enforcement mechanisms provided for and
available under Title VI, Title IX, the Age Act, or Section 504 shall
apply for purposes of violations of Section 1557.\6\ The statute
authorizes the Secretary of the U.S. Department of Health and Human
Services (HHS or the Department) to promulgate implementing regulations
for Section 1557.\7\
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\1\ The Patient Protection and Affordable Care Act, Public Law
111-148, was enacted on March 23, 2010. The Healthcare and Education
Reconciliation Act of 2010, Public Law 111-152, which amended and
revised several provisions of the Patient Protection and Affordable
Care Act, was enacted on March 30, 2010. In this rulemaking, the two
statutes are referred to collectively as the ``Patient Protection
and Affordable Care Act,'' ``Affordable Care Act,'' or ``ACA.''
\2\ 42 U.S.C. 2000d et seq.
\3\ 20 U.S.C. 1681 et seq.
\4\ 42 U.S.C. 6101 et seq.
\5\ 29 U.S.C. 794.
\6\ 42 U.S.C. 18116(a).
\7\ Id. 18116(c).
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Section 1557 was effective upon enactment, and the Department's
Office for Civil Rights (OCR) began enforcing the law immediately
thereafter while drafting implementing regulations.\8\
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\8\ See, e.g., Bulletin, U.S. Dep't of Health & Human Servs.,
The Brooklyn Hospital Center Implements Non-Discriminatory Practices
to Ensure Equal Care for Transgender Patients (July 14, 2015),
https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/statement.pdf; OCR Enforcement under Section 1557 of
the Affordable Care Act Sex Discrimination Cases, U.S. Dep't of
Health & Human Servs., https://www.hhs.gov/civil-rights/for-individuals/section-1557/ocr-enforcement-section-1557-aca-sex-discrimination/ (last updated Aug. 1, 2016); see also C.P.
v. Blue Cross Blue Shield, 536 F. Supp. 3d 791, 796 (W.D. Wash.
2021) (citing Tovar v. Essentia Health, 342 F. Supp. 3d 947, 957 (D.
Minn. 2018) (stating ``[a] claim of discrimination in violation of
Section 1557 does not depend on an HHS rule'' in denying a motion to
dismiss a challenge to categorical exclusions for treatment for
gender dysphoria in a health insurance plan); Prescott v. Rady
Children's Hosp. of San Diego, 265 F. Supp. 3d 1090, 1098 (S.D. Cal.
2017) (denying defendant hospital's motion to dismiss gender
identity discrimination complaint under Section 1557 because
Department regulations were not in effect at the time of the alleged
discrimination, holding the claim of discrimination was grounded in
the plain language of the statute).
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1. 2016 Rulemaking
On August 1, 2013, the Department published a Request for
Information in the Federal Register,\9\ followed by issuance of a
Notice of Proposed Rulemaking (NPRM) on September 8, 2015 (2015
NPRM).\10\ The Department finalized the Section 1557 regulation on
[[Page 47826]]
May 18, 2016 (2016 Rule).\11\ The 2016 Rule applied to all health
programs and activities, any part of which received Federal financial
assistance, and all health programs and activities administered by the
Department or by an entity established under Title I of the ACA. The
2016 Rule included provisions intended to provide, for covered health
programs and activities, consistent requirements across all prohibited
forms of discrimination including grievance procedures, designated
employees to coordinate compliance with the law, and notice
requirements. The 2016 Rule included a detailed definition section. The
2016 Rule also required covered entities to provide, in ``significant
communications,'' notice and information regarding the availability of
language assistance services in the 15 most common languages spoken by
limited English proficient \12\ (LEP) persons in each state.
Additionally, it required covered entities to take reasonable steps to
provide meaningful access to each LEP individual eligible to be served
in covered entities' health programs and activities. It further
prohibited discrimination on the basis of sex, including gender
identity; outlined requirements for equal program access on the basis
of sex; and explicitly prohibited discrimination in health-related
insurance and other health-related coverage, including a ban on
categorical exclusions of gender-transition-related care in health
insurance coverage and other health-related coverage. At the time,
though the Department supported a prohibition on discrimination based
on sexual orientation as a matter of policy, the 2016 Rule did not
explicitly prohibit discrimination on the basis of sexual orientation
because no Federal appellate court had yet concluded that sex-based
discrimination included sexual orientation discrimination.\13\ Instead,
relying on the Supreme Court's opinion in Price Waterhouse v.
Hopkins,\14\ the 2016 Rule explained that Section 1557's prohibition of
discrimination on the basis of sex included sex discrimination related
to an individual's sexual orientation where the evidence established
that the discrimination was based on gender stereotypes.\15\ The 2016
Rule explicitly exempted covered entities from complying with any
requirements that would violate applicable Federal statutory
protections for conscience and religious exercise.\16\
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\9\ 78 FR 46558 (Aug. 1, 2013). Responses are available for
public inspection at https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments.
\10\ 80 FR 54171 (Sept. 8, 2015). The 2015 NPRM received roughly
2,160 comments, which are available for public inspection at https://www.regulations.gov/docket/HHS-OCR-2015-0006/comments.
\11\ 81 FR 31375 (May 18, 2016).
\12\ In the Proposed Rule at Sec. 92.4, infra, a limited
English proficient (LEP) individual means an individual whose
primary language for communication is not English and who has a
limited ability to read, write, speak, or understand English. An LEP
individual may be competent in English for certain types of
communication (e.g., speaking or understanding), but still be LEP
for other purposes (e.g., reading or writing).
\13\ 81 FR 31390 (``OCR has decided not to resolve in this rule
whether discrimination on the basis of an individual's sexual
orientation status alone is a form of sex discrimination.'').
\14\ 490 U.S. 228, 250-51 (1989).
\15\ 81 FR 31389, 31390.
\16\ See former 45 CFR 92.2(b)(2). ``Insofar as application of
any requirement under this part would violate applicable Federal
statutory protections for religious freedom and conscience, such
application shall not be required.''
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The 2016 Rule had an effective date of July 18, 2016, except to the
extent that the rule required changes to health insurance or group
health plan benefits or benefit design, in which case the 2016 Rule
applied on the first day of the first plan year that began on or after
January 1, 2017.\17\
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\17\ 81 FR 313756, 31378, 31430, 31466.
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The 2016 Rule was challenged under the Administrative Procedure Act
\18\ (APA) and the Religious Freedom Restoration Act \19\ (RFRA).
Before the rule went into effect, the United States (U.S.) District
Court for the Northern District of Texas, in Franciscan Alliance v.
Burwell, enjoined the Department from enforcing the 2016 Rule's
prohibition against discrimination on the basis of gender identity or
termination of pregnancy.\20\ Subsequently, on October 15, 2019, the
same district court vacated the 2016 Rule insofar as the 2016 Rule
defined discrimination on the basis of sex to include gender identity
and termination of pregnancy.\21\ In 2021, the court in Franciscan
Alliance issued an order enjoining the Department from interpreting or
enforcing Section 1557 against the plaintiffs in that case in a manner
that would require them to perform or provide insurance coverage for
gender transition services or abortion.\22\ In Religious Sisters of
Mercy et al. v. Becerra et al., the court enjoined the Department from
enforcing Section 1557 against the plaintiffs in that case in a manner
that would require them to perform or provide insurance coverage for
gender transition services.\23\ Both decisions have been appealed on
standing and ripeness grounds, among other things. As of the
publication of this NPRM, appeals are pending in the Fifth and Eighth
Circuits. More recently, another district court in the District of
North Dakota in Christian Employers Alliance v. U.S. Equal Employment
Opportunity Commission et al. enjoined the Department from enforcing
Section 1557 against the plaintiffs in that case in a manner that would
require them to perform or provide insurance coverage for gender
transition services or restrict or compel their speech on gender
identity issues.\24\
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\18\ 5 U.S.C. 551 et seq.
\19\ 42 U.S.C. 2000bb et seq.
\20\ Franciscan All., Inc. v. Burwell, 227 F. Supp. 3d 660 (N.D.
Tex. 2016).
\21\ Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928 (N.D.
Tex. 2019).
\22\ Franciscan All., Inc. v. Becerra, 553 F. Supp. 3d 361 (N.D.
Tex. 2021), amended, No. 7:16-cv-00108-O, 2021 WL 6774686 (N.D. Tex.
Oct. 1, 2021), appeal pending, No. 21-11174 (5th Cir. Nov. 21,
2021).
\23\ Religious Sisters of Mercy v. Azar, 513 F. Supp. 3d 1113
(D.N.D. 2021), judgment entered sub nom. Religious Sisters of Mercy
v. Cochran, No. 3:16-cv-00386, 2021 WL 1574628 (D.N.D. Feb. 19,
2021), appeal pending, No. 21-1890 (8th Cir. April 20, 2021) (oral
argument held Dec. 15, 2021).
\24\ Christian Emp'rs All. v. EEOC, No. 21-cv-00195, 2022 WL
1573689 (D.N.D. May 16, 2022).
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2. 2020 Rulemaking
On June 14, 2019, the Department published a new Section 1557
Notice of Proposed Rulemaking (2019 NPRM), proposing to rescind large
portions of the 2016 Rule.\25\ Citing the Franciscan Alliance
litigation, the 2019 NPRM proposed to rescind the 2016 Rule's
definition of ``on the basis of sex,'' and, given ``the likelihood that
the Supreme Court [would] be addressing the issue in the near future
[in its Bostock v. Clayton County \26\ ruling],'' the preamble to the
2019 NPRM proposed not to include a new definition for ``on the basis
of sex.'' However, the preamble to the 2019 NPRM identified examples of
other government entities that referred to ``sex'' in ``binary and
biological'' terms and suggested that Section 1557's prohibition on sex
discrimination may not extend to gender identity discrimination.\27\
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\25\ 84 FR 27846 (June 14, 2019).
\26\ 140 S. Ct. 1731 (2020).
\27\ 84 FR 27853-55, 27856-57.
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The 2019 NPRM also proposed to replace or rescind significant
portions of the 2016 Rule in order to ``relieve billions of dollars in
undue regulatory burdens,'' and ``eliminate provisions [of the 2016
Rule] that are inconsistent or redundant with pre-existing civil rights
statutes.'' \28\ The most common cost concern raised regarding the 2016
Rule was the notice requirements at former Sec. 92.8, which required
covered entities to include a notice of nondiscrimination and notice of
the availability of language assistance services (``taglines'') in a
range of communications.\29\
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\28\ 84 FR 27848-49.
\29\ See e.g., 84 FR 27857-58.
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In addition, the 2019 NPRM proposed to eliminate the following
provisions of the 2016 Rule: the definitions section, including the
definition of ``health program or activity'' to include all of the
[[Page 47827]]
operations of an entity principally engaged in providing or
administering health insurance or health-related coverage (former Sec.
92.4); the requirement to designate a responsible employee to carry out
a covered entity's responsibilities under Section 1557 (former Sec.
92.7(a)); the requirement to adopt grievance procedures (former Sec.
92.7(b)); notice and tagline requirements (former Sec. 92.8); the
approach to accepting disparate impact claims with respect to
allegations of sex discrimination (former Sec. 92.101(b)(3)(ii) and
(iii)); the requirement for covered entities to justify sex-specific
health programs or activities by demonstrating that the sex-specific
health program or activity is substantially related to the achievement
of an important health-related or scientific objective (former Sec.
92.101(b)(3)(iv)); the requirement for a covered entity to take
reasonable steps to provide meaningful access to each LEP individual
(former Sec. 92.201(a)) (emphasis added); the prohibition on
discrimination in health-related insurance and other health-related
coverage, including a prohibition of blanket exclusions of coverage for
care related to gender transition (former Sec. 92.207); the coverage
of certain employee health benefit programs (former Sec. 92.208); the
prohibition of discrimination on the basis of association (former Sec.
92.209); reference to compensatory damages for Section 1557 violations
to the extent such damages are available under underlying Federal civil
rights statutes (former Sec. 92.301(b)); and the provision regarding
the obligation to provide OCR access to review records and sources of
information, and to otherwise comply with the Department's
investigations (former Sec. 92.303(c)).
On June 12, 2020, the Department publicly posted its second Section
1557 Final Rule (2020 Rule), making no substantive changes from the
2019 NPRM.\30\ On June 15, 2020, the U.S. Supreme Court issued its
ruling in Bostock v. Clayton County, holding that discrimination on the
basis of sexual orientation and gender identity constitutes prohibited
discrimination because of sex under Title VII of the Civil Rights Act
of 1964 (Title VII).\31\ The 2020 Rule was published in the Federal
Register on June 19, 2020 with preamble language that was inconsistent
with the Supreme Court's Bostock opinion.\32\
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\30\ 85 FR 37160 (June 19, 2020) (``After considering public
comments, in this final rule, the Department revises its Section
1557 regulations . . . as proposed, with minor and primarily
technical corrections.''). The 2019 NPRM received roughly 155,960
comments, which are available for public inspection at https://www.regulations.gov/docket/HHS-OCR-2019-0007.
\31\ 140 S. Ct. 1731 (2020).
\32\ 85 FR 37178-37180.
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Following the issuance of the 2020 Rule, which included an
effective date of August 18, 2020,\33\ litigants in various U.S.
District Courts sought to enjoin the rule on the basis that it was,
among other allegations, arbitrary and capricious and contrary to law
under the APA.\34\ While these challenges addressed a range of changes
made to the 2016 Rule, they primarily focused on the 2020 Rule's repeal
of the definition of ``on the basis of sex''; the incorporation of
provisions governing the 2020 Rule's relationship to other laws related
to various religious exemptions; the scope of coverage; and the
elimination of language access provisions. As a result of these
challenges, the Department is currently preliminarily enjoined from
enforcing its repeal of certain portions of the 2016 Rule's definition
of ``on the basis of sex,'' and of former 45 CFR 92.206, regarding
equal program access on the basis of sex, as well as from enforcing the
2020 Rule's incorporation of Title IX's religious exemption.\35\ The
five pending lawsuits were stayed for the Department's review of the
2020 Rule.
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\33\ Id. at 37169.
\34\ Walker v. Azar, No. 20-cv-2834 (E.D.N.Y. June 26, 2020);
Whitman-Walker Clinic v. U.S. Dep't of Health & Human Servs., No.
1:20-cv-01630 (D.D.C. June 22, 2020); N.Y. v. U.S. Dep't of Health &
Human Servs., No. 1:20-cv-05583 (S.D.N.Y. July 20, 2020); BAGLY v.
U.S. Dep't of Health & Human Servs., No. 20-cv11297 (D. Mass. July
9, 2021); Chinatown Serv. Ctr. v. U.S. Dep't of Health & Human
Servs., No. 1:21-cv-00331 (D.D.C. Oct. 13, 2021).
\35\ Walker v. Azar, 480 F. Supp. 3d 417, 430 (E.D.N.Y. 2020)
(enjoining repeal of definition of ``on the basis of sex,''
including sex stereotyping); Whitman-Walker Clinic v. U.S. Dep't of
Health & Human Servs., 485 F. Supp. 3d 1 (D.D.C. 2020) (enjoining
repeal of definition of ``on the basis of sex,'' insofar as it
includes ``discrimination on the basis of . . . sex stereotyping''
and enjoining incorporation of Title IX religious exemption); Walker
v. Azar, No. 20-cv-2834, 2020 WL 6363970, at *4 (E.D.N.Y. Oct. 29,
2020) (enjoining repeal of former 45 CFR 92.206). The 2020 Rule
provides that ``[i]nosofar as the application of any requirement
under this part would violate, depart from, or contradict
definitions, exemptions, affirmative rights, or protections provided
by'' various statutes including Title IX's religious exemption,
``such application shall not be imposed or required.'' 45 CFR
92.6(b). Relying on language in the 2020 Rule's preamble, the
Whitman-Walker court preliminarily construed Sec. 92.6(b) to
explicitly incorporate Title IX's religious exemption. Whitman-
Walker Clinic, 485 F. Supp. 3d at 14, 43. These orders did not
affect the district court's vacatur of the 2016 Rule insofar as it
defined sex discrimination to include gender identity discrimination
in Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928 (N.D. Tex.
2019).
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3. May 10, 2021 Notification of Interpretation (``Bostock
Notification'')
On May 10, 2021, the Department publicly announced, consistent with
the Supreme Court's decision in Bostock, that the Department would
interpret Section 1557's prohibition on sex discrimination to include
(1) discrimination on the basis of sexual orientation and (2)
discrimination on the basis of gender identity (``Bostock
Notification'').\36\ The Department explained that its interpretation
will guide OCR's complaint processing and investigations; however, the
interpretation did not ``determine the outcome in any particular case
or set of facts.'' In addition, the Department explained that its
Section 1557 enforcement will comply with RFRA and all other legal
requirements, including applicable court orders that have been issued
in litigation involving Section 1557 regulations.
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\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.'').
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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.
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\37\ Neese v. Becerra, No. 2:21-cv-00163-Z (N.D. Tex. Aug. 25,
2021); Am. Coll. of Pediatricians v. Becerra, No. 1:21-cv-00195
(E.D. Tenn. Aug. 27, 2021); Christian Emp'rs All. v. EEOC, No. 21-
cv-00195 (D.N.D. Oct. 18, 2021).
\38\ No. 2:21-cv-00163-Z, 2022 WL 1265925, at *14 (N.D. Tex.
Apr. 26, 2022).
\39\ No. 21-cv-00195, 2022 WL 1573689, at *9 (D.N.D. May 16,
2022).
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4. March 2, 2022 Notice and Guidance on Gender Affirming Care, Civil
Rights, and Patient Privacy
On March 2, 2022, the Department published guidance, consistent
with the Bostock Notification, that Section 1557
[[Page 47828]]
prohibits discrimination on the basis of gender identity in access to
covered health programs and activities.\40\ Specifically, the
Department stated that ``[c]ategorically refusing to provide treatment
to an individual based on their gender identity is prohibited
discrimination. Similarly, federally funded covered entities
restricting an individual's ability to receive medically necessary
care, including gender-affirming care, from their health care provider
solely on the basis of their sex assigned at birth or gender identity
likely violates Section 1557.'' \41\ On March 31, 2022, the U.S.
Department of Justice (DOJ) issued a letter to State Attorneys General
addressing protections against unlawful discrimination based on gender
identity, including protections afforded by Section 1557.\42\
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\40\ U.S. Dep't of Health & Human Servs., HHS Notice and
Guidance on Gender Affirming Care, Civil Rights, and Patient Privacy
(Mar. 2, 2022), https://www.hhs.gov/sites/default/files/hhs-ocr-notice-and-guidance-gender-affirming-care.pdf.
\41\ Id. at 2.
\42\ Letter from Kristen Clarke, Assistant Att'y Gen., Civil
Rights Div., U.S. Dep't of Justice, to State Att'ys Gen. (Mar. 31,
2022), https://www.justice.gov/opa/press-release/file/1489066/download.
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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\
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\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.
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\45\ The term ``health coverage'' generally refers to a
``[l]egal entitlement to payment or reimbursement for your health
care costs, generally under a contract with a health insurance
company, a group health plan offered in connection with employment,
or a government program like Medicare, Medicaid, or the Children's
Health Insurance Program (CHIP).'' Glossary: Health coverage,
HealthCare.gov, https://www.healthcare.gov/glossary/health-coverage/
(last visited June 15, 2022).
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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.
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\46\ E.g., Memorandum from Pamela S. Karlan, Principal Deputy
Assistant Att'y Gen., to Fed. Agency Civil Rights Dirs. & Gen.
Counsels (Mar. 26, 2021) [hereinafter Karlan Memo], https://www.justice.gov/crt/page/file/1383026/download; 86 FR 32637 (June
22, 2021) (U.S. Dep't of Educ., notice of interpretation).
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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.
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\47\ 45 CFR 84.61 (adopting the procedural provision of Title
VI).
\48\ Id. Sec. 86.71 (adopting the procedural provision of Title
VI).
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The Department is proposing to revise its position regarding
whether Medicare Part B payments constitute Federal financial
assistance for purposes of Federal civil rights jurisdiction under
Title VI, Section 504, Title IX, the Age Act, and Section 1557. The
Department explains that payments made under the Medicare Part B
program meet the longstanding definition of ``Federal financial
assistance,'' and proposes necessary conforming amendments to the
appendices of the implementing regulations for Title VI and Section
504.
Finally, the Department proposes to make limited amendments to the
Centers for Medicare & Medicaid Services (CMS) Medicaid, Children's
Health Insurance Program (CHIP), and Program of All-Inclusive Care for
the Elderly (PACE) nondiscrimination regulatory provisions, as well as
nondiscrimination provisions applicable to group and individual health
insurance markets and Health Insurance Exchanges to clarify that
discrimination on the basis of sex
[[Page 47829]]
includes discrimination on the basis of sexual orientation and gender
identity.
II. Reasons for the Proposed Rulemaking
The Department is undertaking this rulemaking to better align the
Section 1557 regulation with the statutory text of 42 U.S.C. 18116, to
reflect recent developments in civil rights case law, to address
unnecessary confusion in compliance and enforcement resulting from the
2020 Rule, and to better address issues of discrimination that
contribute to negative health interactions and outcomes. Upon further
consideration and informed by civil rights issues raised in the context
of the coronavirus disease 2019 (COVID-19) pandemic, the Department
believes that the 2020 Rule creates substantial obstacles to the
Department's ability to address discrimination across the health
programs and activities it financially supports or administers, thereby
undermining the statutory purpose of Section 1557 and hindering the
Department's mission of pursuing health equity and protecting public
health.
In developing this NPRM, the Department undertook a significant
review of previous rulemaking and developments in civil rights law
since the publication of both the 2016 and 2020 Final Rules. The
Department also engaged in a series of listening sessions with a
diverse range of stakeholder groups.\49\
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\49\ A list of stakeholder groups and notes from these listening
sessions and written materials provided during or after the
listening sessions are attached to the docket of this proposed rule
as a supplemental material at federalregister.gov.
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A. The Scope of the 2020 Rule Is Not the Best Reading of the Affordable
Care Act and Section 1557's Statutory Text
In the Department's view, the scope of application in the 2020 Rule
is not the best reading of the statutory text of Section 1557 in two
significant respects. First, the 2020 Rule applies to ``any program or
activity administered by the Department under Title I of the [ACA].''
\50\ However, the statutory language provides that Section 1557's
discrimination prohibitions apply to covered programs and activities
that are ``administered by an Executive Agency or any entity
established under this title.'' \51\ The operative word, ``or,''
distinguishes programs and activities operated by an Executive Agency
from those operated by a Title I entity. The 2020 Rule, however,
construes this language to cover only programs and activities
administered by the Department under Title I of the ACA, and programs
and activities administered by any entity established under Title I of
the ACA.\52\ The reading of the statute in the 2020 Rule is strained,
and the Department does not believe that the best way to resolve any
ambiguity is to construe the phrase ``established under this title'' as
modifying the phrase ``administered by an Executive Agency.'' The
preamble to the 2020 Rule explained that its construction was ``at
least as reasonable'' as the 2016 Rule's resolution of this issue.\53\
However, upon further analysis the Department now believes that the
reading proposed herein, which does not limit application to only
programs and activities administered by the Department under Title I of
the ACA, better reflects the statutory language as well as Congress'
intent.\54\
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\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).
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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.
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\55\ 45 CFR 92.3(c).
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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\
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\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).
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On January 20, 2021, President Biden, in Executive Order (E.O.)
13988, directed agencies to review all agency actions, including
regulations, that prohibit discrimination on the basis of sex to
determine if they were inconsistent with the Court's reasoning in
Bostock.\61\ In response, the Department assessed its Section 1557
regulation and enforcement policies and issued its Bostock
Notification. As discussed previously, the Bostock Notification stated
that the Department would interpret and enforce Section 1557's sex
discrimination prohibitions
[[Page 47830]]
consistent with Bostock, while recognizing that the interpretation did
not ``determine the outcome in any particular case or set of facts''
and that the Department would comply with RFRA and all other legal
requirements.\62\ For these reasons and those described in this NPRM,
the Department believes the understanding of sex discrimination
described in the 2020 Rule's preamble \63\ is an inaccurate reading of
the statute.
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\61\ 86 FR 7023, 7023-24 (Jan. 25, 2021).
\62\ 86 FR 27984; see also Karlan Memo, supra note 46.
\63\ 85 FR 37160, 37178-79 (June 19, 2020).
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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.
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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.
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\71\ 45 CFR 92.2.
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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,
https://ssir.org/articles/entry/ensuring_equitable_access_to_vaccines#.
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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), https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/26/memorandum-on-redressing-our-nations-and-the-federal-governments-history-of-discriminatory-housing-practices-and-policies/; Memorandum on
Condemning and Combating Racism, Xenophobia, and Intolerance Against
Asian Americans and Pacific Islanders in the United States (2021),
https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/26/memorandum-condemning-and-combating-racism-xenophobia-and-intolerance-against-asian-americans-and-pacific-islanders-in-the-united-states/; E.O. 14012, 86 FR 8722 (2021); E.O.14031, 86 FR
29675 (2021); E.O. 14035, 86 FR 34593 (2021); E.O. 14041, 86 FR
50443 (2021); E.O.14045, 86 FR 51581 (2021); and other Presidential
Actions.
\80\ 156 Cong. Rec. S1842 (daily ed. Mar. 23, 2010), https://www.congress.gov/congressional-record/2010/03/23/senate-section/article/S1821-6.
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1. Health Equity and Discrimination Related to Race, Color, and
National Origin
Members of racial and ethnic groups that have historically faced
discrimination and structural disadvantages in the United States
experience disproportionately poor health status.\81\ Though health
indicators for aggregated racial and ethnic populations may suggest
positive outcomes for some groups, broad demographic categories often
conceal health disparities within and among racial and ethnic
subgroups. For example, positive overall data on the health of persons
of Asian descent often obscure disparities among subgroups.\82\ One
study revealed that while Asian persons in the aggregate appeared to be
healthier than white persons in the United States, disaggregation of
the data shows that persons of Filipino descent experience a higher
prevalence of fair or poor health, obesity, high blood pressure,
diabetes, or asthma when compared with white persons.\83\ Similarly,
while the rate of low birth weight infants is lower for the total
Hispanic/Latino population in the United States in comparison to non-
Hispanic white people, Puerto Ricans have a low birth weight rate that
is almost twice that of non-Hispanic white people.\84\
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\81\ U.S. Dep't of Health & Human Servs., Office of Minority
Health, Minority Population Profiles, https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=26 (last
visited Nov. 9, 2021).
\82\ Alexander Adia et al., Health Conditions, Outcomes, and
Service Access Among Filipino, Vietnamese, Chinese, Japanese, and
Korean Adults in California, 2011-2017, 110 a.m. J. of Pub. Health
520 (2020), https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2019.305523.
\83\ Id.
\84\ U.S. Dep't of Health & Human Servs., Office of Minority
Health, Profile: Hispanic/Latino Americans https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=3&lvlid=64 (last visited
Nov. 19, 2021).
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Beyond poor health outcomes, communities of color in the United
States have long experienced disparities in health care--including in
health insurance coverage, access to care, quality of care, maternal
mortality rates, and inclusion in biomedical research. For example,
American Indian/Alaska Native, Black, and Hispanic/Latino adults
account for a disproportionately high share of the uninsured
population. American Indian/Alaska Native individuals under 65 have an
uninsured rate of 28 percent, higher than any other racial or ethnic
group.\85\ Hispanic/Latino people comprise 29 percent of the uninsured
yet make up 19 percent of the U.S. population.\86\ These
[[Page 47832]]
disparities are particularly salient in states that did not expand
Medicaid; 37 percent of the total uninsured Black population in the
United States reside in just three such states.\87\
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\85\ The U.S. Census does not classify the Indian Health Service
as health coverage. U.S. Dep't of Health & Human Servs., Assistant
Sec'y for Policy & Evaluation, Office of Health Policy, Issue Brief:
Health Insurance Coverage and Access to Care for American Indians
and Alaska Natives: Current Trends and Key Challenges, p. 1 (July
22, 2021), aspe-aian-health-insurance-coverage-ib.pdf (hhs.gov).
\86\ U.S. Dep't of Health & Human Servs., Assistant Sec'y for
Policy & Evaluation, Office of Health Policy, Issue Brief: The
Remaining Uninsured: Geographic and Demographic Variation, p. 1
(Mar. 23, 2021), https://aspe.hhs.gov/sites/default/files/private/pdf/265286/Uninsured-Population-Issue-Brief.pdf.
\87\ Id. at p. 8.
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In addition to experiencing disparities in coverage, people of
color are also more likely than white people to experience a lower
quality of care. For example, HHS' 2021 National Health Care Quality
and Disparities Report evaluated whether different racial groups
received worse care than white individuals in the areas of patient
safety, person-centered care, care coordination, the effectiveness of
care, healthy living, and affordable care. The study found that Black
individuals received worse care than white individuals for 43 percent
of 195 quality measures, American Indian/Alaska Native individuals
received worse care than white individuals for 40 percent of 108
quality measures, Hispanic/Latino individuals received worse care than
white individuals for 36 percent of 172 quality measures, Native
Hawaiian/Pacific Islander individuals reported receiving a lower level
of care than white people for 28 percent of 81 quality measures, and
where Asian individuals received worse care than white individuals, it
was for 28 percent of 173 quality measures.\88\ While many factors may
contribute to these disparities, the report highlights the role of
social determinants of health,\89\ which include racial and ethnic
discrimination, limited English proficiency, and presence of health
care laws.\90\
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\88\ U.S. Dep't of Health & Human Servs., Agency for Healthcare
Research & Quality, 2021 National Healthcare Quality and Disparities
Report Executive Summary, pp. ES-3, D-3-D-51 (Dec. 2020), https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2021qdr.pdf.
\89\ Social determinants of health are the conditions in the
environments where people are born, live, learn, work, play,
worship, and age that affect a wide range of health, functioning,
and quality-of-life outcomes and risks. Social Determinants of
Health, Healthy People 2030, U.S. Dep't of Health & Human Servs.,
Office of Disease Prevention & Health Promotion, https://health.gov/healthypeople/objectives-and-data/social-determinants-health (last
visited January 21, 2022).
\90\ U.S. Dep't of Health & Human Servs., Agency for Healthcare
Research & Quality, 2019 National Healthcare Quality and Disparities
Report Executive Summary, p. 7 (Dec. 2020), https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/2019qdr-final-es-cs061721.pdf.
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Further, the disparities in maternal mortality rates are alarming.
According to National Vital Statistics System data, in 2020, the
maternal mortality rate for non-Hispanic/Latino Black women was 55.3
deaths per 100,000 live births, 2.9 times the rate for non-Hispanic/
Latino white women (19.1).\91\ This disparity is increasing, with
maternal mortality rate increases between 2019 and 2020 for non-
Hispanic/Latino Black and Hispanic/Latino people.\92\ An analysis of
vital statistics mortality data showing the cause of maternal deaths in
the United States from 2016-2017 revealed maternal mortality for Black
women largely resulted from conditions like preeclampsia and
cardiomyopathy, and were believed to be preventable.\93\ This study
also found an increased risk of maternal mortality from multiple causes
in Black women, which indicates negative impacts of structural racism
on health and health care in the United States. The Biden-Harris
Administration has taken initial steps to address these longstanding
disparities, issuing the first-ever Presidential proclamation observing
Black Maternal Health Week \94\ and hosting the first-ever Federal
``Maternal Health Day of Action,'' which included a nationwide call to
action to reduce mortality. The Administration has also announced
several key policy actions, including CMS' intention to propose the
first-ever hospital quality designation specifically focused on
maternity care.\95\
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\91\ Donna L. Hoyert, U.S. Dep't of Health & Human Servs., Ctrs.
for Disease Control & Prevention, Maternal Mortality Rates in the
United States (Feb. 2022), https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2020/E-stat-Maternal-Mortality-Rates-2022.pdf.
\92\ Id.
\93\ Marian F. MacDorman et al., Racial and Ethnic Disparities
in Maternal Mortality in the United States Using Enhanced Vital
Records, 2016-2017, 111 a.m. J. Pub. Health 1673, 1671 (2021),
https://ajph.aphapublications.org/doi/10.2105/AJPH.2021.306375.
\94\ The White House Briefing Room, A Proclamation on Black
Maternal Health Week, 2021 (April 13, 2021), www.whitehouse.gov/briefing-room/presidential-actions/2021/04/13/a-proclamation-on-black-maternal-health-week-2021/;see also, The White House Briefing
Room, A Proclamation on Black Maternal Health Week, 2022 (April 8,
2022), https://www.whitehouse.gov/briefing-room/presidential-actions/2022/04/08/a-proclamation-on-black-maternal-health-week-2022/.
\95\ The White House Briefing Room, FACT SHEET: Biden-Harris
Administration Announces Initial Actions to Address the Black
Maternal Health Crisis (Apr. 13, 2021), www.whitehouse.gov/briefing-room/statements-releases/2021/04/13/fact-sheet-biden-harris-administration-announces-initial-actions-to-address-the-black-maternal-health-crisis./
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While research is beginning to reveal more information about the
potential causes of Black maternal mortality, less research exists
about the causes of maternal mortality among American Indian/Alaska
Native women. A recent study documented the available literature on
American Indian/Alaska Native women and found that the three leading
causes of maternal mortality among such women are hemorrhage,
cardiomyopathies, and hypertensive disorders of pregnancy.\96\ The
authors ultimately concluded that more research is needed to determine
the root causes of maternal mortality among American Indian/Alaska
Native women, but suggested that to reduce American Indian/Alaska
Native maternal mortality and eliminate racial/ethnic disparities,
provider-related factors including implicit bias must be addressed.\97\
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\96\ Jennifer L. Heck et al., Maternal Mortality Among American
Indian/Alaska Native Women: A Scoping Review. 30 J. of Women's
Health 220, 229 (2021), https://www.liebertpub.com/doi/epdf/10.1089/jwh.2020.8890.
\97\ Id. at 226.
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Persistent bias and racism in the health care system, as well as
across other social determinants of health, also contribute to health
challenges for people of color. For example, one study showed that
medical students and medical residents hold false beliefs about
biological differences between Black people and white people, and these
falsely held beliefs are associated with racial disparities in pain
perception and treatment recommendation accuracy.\98\ A recent study
analyzing patients' electronic health records (EHR) found that Black
patients had disproportionately higher odds of being described with one
or more negative descriptors in the history and notes of the EHR than
their white counterparts.\99\ The authors note that this may indicate
implicit racial bias against Black patients, potentially leading to
stigmatizing Black patients and compromising the care they receive. A
recent survey indicates that, shaped by these experiences and
perceptions, most Black adults believe that racial discrimination is
not uncommon in health care.\100\ Black adults, and Black women in
particular, are more likely than white people to report certain
negative health care experiences.\101\ Racism and discrimination
experienced outside the health care setting may also affect the mental
and physical well-being of individuals of color. For example, Black
people who experience
[[Page 47833]]
racism were more likely to experience deteriorations in health that
contribute to premature death, including increased risk of inflammation
and chronic illness.\102\
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\98\ Kelly M. Hoffman et al., Racial Bias in Pain Assessment and
Treatment Recommendations, and False Beliefs About Biological
Differences Between Blacks and Whites, 113 Proc. of the Nat'l Acad.
of Sci. 4296, 4301 (2016), https://doi.org/10.1073/pnas.1516047113.
\99\ Michael Sun et al., Negative Patient Descriptors:
Documenting Racial Bias in the Electronic Health Record, 41 Health
Affairs 203, 211 (2022), https://www.healthaffairs.org/doi/pdf/10.1377/hlthaff.2021.01423.
\100\ Liz Hamel et al., The Kaiser Family Found., The Undefeated
Survey on Race and Health, p. 4 (2020), https://files.kff.org/attachment/Report-Race-Health-and-COVID-19-The-Views-and-Experiences-of-Black-Americans.pdf.
\101\ Id. at 5.
\102\ Jamila Taylor, The Century Found., Racism, Inequality, and
Health Care for African Americans, p. 6 (2019), https://production-tcf.imgix.net/app/uploads/2019/12/19172443/AfAmHealth_Jamila_PDF.pdf.
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It is well-documented that LEP people experience obstacles to
accessing health care in the United States.\103\ Language barriers
negatively affect LEP patients' ability to comprehend their diagnoses
and understand medical instructions when they are delivered in English,
and impact their comfort with post-discharge care regimens.\104\ For
example, Hispanic/Latino LEP people report worse access to care and
report the receipt of fewer preventive services than Hispanic/Latino
people who speak English proficiently.\105\ For Asian Americans who are
not proficient in English, language barriers are one of the most
significant challenges to accessing health care, including making an
appointment, communicating with health care professionals, and gaining
knowledge about an illness.\106\ This is even more pronounced among
older Asian Americans, who are more likely to have limited English
proficiency.\107\ Studies show that LEP patients experience longer
hospital stays--leading to a greater risk of line infections, surgical
infections, falls, and pressure ulcers--when compared to English-
speaking patients.\108\ Because LEP patients have greater difficulty
understanding medical instructions when those instructions are given in
English, they are at higher risk of surgical delays and
readmissions.\109\ Although the use of qualified interpreters is
effective in improving care for LEP patients, some clinicians choose
not to use them, fail to use them effectively, or rely instead on ad
hoc interpreters--such as family members or untrained bilingual
staff.\110\ However, in addition to posing legal and ethical concerns,
ad hoc interpreters are more likely to make mistakes than professional
interpreters.\111\ Also, clinicians with basic or intermediate non-
English spoken language skills often attempt to communicate with the
patient on their own without using an interpreter, increasing patient
risk.\112\ These barriers contribute to disparities in health outcomes
for LEP individuals, which have likely worsened during the COVID-19
pandemic.\113\
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\103\ Jason Espinoza et al., How Should Clinicians Respond to
Language Barriers that Exacerbate Health Inequity?, 23 a.m. Med.
Ass'n J. of Ethics E109 (2021) (LEP patients and families in the
U.S. ``face barriers to health service access, experience lower
quality care, and suffer worse health outcomes''), https://journalofethics.ama-assn.org/sites/journalofethics.ama-assn.org/files/2021-02/cscm3-2102.pdf.
\104\ Id.; see also Leah S. Karliner et al., Convenient Access
to Professional Interpreters in the Hospital Decreases Readmission
Rates and Estimated Hospital Expenditures for Patients with Limited
English Proficiency, 55 Med. Care 199 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5309198/.
\105\ Espinoza, supra note 103.
\106\ Wooksoo Kim et al., Barriers to Healthcare Among Asian
Americans, 25 Soc. Work in Pub. Health 286, 289 (2010), https://www.tandfonline.com/doi/pdf/10.1080/19371910903240704?needAccess=true.
\107\ Id.
\108\ U.S. Dep't of Health & Human Servs., Agency for Healthcare
Research & Quality, Executive Summary: Improving Patient Safety
Systems for Patients with Limited English Proficiency (Sept. 2020),
https://www.ahrq.gov/health-literacy/professional-training/lepguide/exec-summary.html#what.
\109\ Id.
\110\ Espinoza, supra note 103, at 110.
\111\ See, e.g., Glenn Flores et al., Errors of Medical
Interpretation and Their Potential Clinical Consequences: A
Comparison of Professional Versus Ad Hoc Versus No Interpreters, 5
Annals of Emerg. Med. 545 (Nov. 1, 2012), https://pubmed.ncbi.nlm.nih.gov/22424655/; Ali Labaf et al., The Effect of
Language Barrier and Non-Professional Interpreters on the Accuracy
of Patient-Physician Communication in Emergency Department, 3 Adv.
J. Emerg. Med., June 6, 2019, at p. 4, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6789075/pdf/AJEM-3-e38.pdf.
\112\ U.S. Dep't of Health & Human Servs., Agency for Healthcare
Research & Quality, supra note 108.
\113\ See Lala Tanmoy Das et al., Addressing Barriers to Care
for Patients with Limited English Proficiency During the COVID-19
Pandemic, Health Affairs Blog (July 29, 2020), https://www.healthaffairs.org/do/10.1377/hblog20200724.76821/full/.
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2. Health Equity and Discrimination Related to Sex
Disparities in women's health are well-documented. For example,
although heart disease is the leading cause of death for men and women
in the United States, women are more likely to experience delays in
emergency care and treatment to control their cholesterol levels.\114\
Women are also more likely than men to die from a heart attack.\115\
The delay in the diagnosis and treatment of heart disease is just one
of many disparities women experience in health care settings. Some
evidence suggests that women treated by male physicians for heart
attacks experience higher rates of mortality compared to women treated
by a female physician or by a male physician who has had more exposure
to female patients and female physicians.\116\
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\114\ What Health Issues or Conditions Affect Women Differently
than Men?, U.S. Dep't of Health & Human Servs., Nat'l Inst. of Child
Health & Human Dev., https://www.nichd.nih.gov/health/topics/womenshealth/conditioninfo/howconditionsaffect (last visited Mar.
15, 2022).
\115\ Brad Greenwood et al., Patient-Physician Gender
Concordance and Increased Mortality Among Female Heart Attack
Patients, 115 Proc. Nat'l Acad. Sci. 8569, 8574 (2018), https://www.pnas.org/doi/epdf/10.1073/pnas.1800097115.
\116\ Id.
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Studies regarding pain management have also indicated the risk of
gender bias, based on the notion that men and women are ``separate and
different in manners and needs,'' with a review of the literature
revealing studies that show women receive less adequate pain
medication, more antidepressants, and more mental health referrals
compared to men.\117\ Studies indicate this may have to do with
erroneous gender stereotypes that men are ``stoic, in control, and
avoid[] seeking health care,'' whereas women are presented as ``more
sensitive to pain and more willing to show and to report pain''
compared to men.\118\
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\117\ Anke Samulowitz et al., ``Brave Men'' and ``Emotional
Women'': A Theory-Guided Literature Review on Gender Bias in Health
Care and Gendered Norms Towards Patients with Chronic Pain, Pain
Res. & Mgmt., Feb. 25, 2018, at pp. 1, 9-10, https://downloads.hindawi.com/journals/prm/2018/6358624.pdf; see also
Danielle M. Wesolowicz et al., The Roles of Gender and Profession on
Gender Role Expectations of Pain in Health Care Professionals, 11 J.
of Pain Res. 1121 (2018), https://www.dovepress.com/getfile.php?fileID=42642.
\118\ Samulowitz, supra note 117, at pp. 1, 9.
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LGBTQI+ individuals in the United States also face pervasive health
disparities and barriers in accessing needed health care. Throughout
this preamble, we will use the full acronym of LGBTQI+ when talking
broadly about individuals who are LGBTQI+ but will use a subset of the
acronym (e.g., ``LGB,'' ``LGBT'' or ``LGBTQ'') when discussing studies,
research, or concepts that apply only to a subset of this group.
Overall, LGBTQI+ individuals report being in poorer health than
non-LGBTQI+ individuals. LGBTQ+ individuals, moreover, are at increased
risk for or are particularly affected by certain health conditions,
including sexually transmitted infections,\119\ Human Immunodeficiency
Virus (HIV),\120\ obesity,\121\ conditions associated with tobacco,
alcohol, and other substance use,\122\ and mental
[[Page 47834]]
health conditions,\123\ including suicidality.\124\ LGB people are more
likely to acquire a disability at a younger age than heterosexual
individuals.\125\
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\119\ Hilary Daniel et al., Annals of Internal Med. Position
Papers, Lesbian, Gay, Bisexual, and Transgender Health Disparities:
Executive Summary of a Policy Position Paper from the American
College of Physicians (2015), https://www.acpjournals.org/doi/full/10.7326/M14-2482?journalCode=aim.
\120\ U.S. Dep't of Health & Human Servs., Ctrs. for Disease
Control & Prevention, HIV Surveillance Report, 2019; Vol. 32, pp.
19, 24, 46 (2021), https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-updated-vol-32.pdf.
\121\ Daniel, supra note 119.
\122\ Id.
\123\ Charlotte Patterson et al., Nat'l Acads. of Sci., Eng'g, &
Med., Understanding the Well-Being of LGBTQI+ Populations, p. 298
(2020), https://doi.org/10.17226/25877.
\124\ Daniel, supra note 119.
\125\ Id.
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Discrimination also poses a major challenge to the health of
LGBTQI+ people. A 2018 literature review revealed that 82 percent of
studies found ``robust evidence that discrimination on the basis of
sexual orientation or gender identity is associated with harms to the
health of LGBT people.'' \126\ Anti-LGBT discrimination is associated
with a higher risk of poor mental and physical health, including
depression, anxiety, post-traumatic stress disorder, substance use, and
cardiovascular disease.\127\ These effects are exacerbated for youth
and people of color who identify as LGBT.\128\ Significant proportions
of LGBTQ people report negative experiences with doctors and other
health care providers.\129\ According to a recent survey, negative
experiences with providers occur at higher rates among transgender
people, particularly transgender people of color, than among other
LGBTQ subgroups.\130\
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\126\ What We Know Project, Cornell U., What Does the Scholarly
Research Say About the Effects of Discrimination on the Health of
LGBT People (2019), https://whatweknow.inequality.cornell.edu/wp-content/uploads/2019/12/LGBT-Discrimination-Printable-Findings-121319.pdf.
\127\ Lesbian, Gay, Bisexual, and Transgender Health,
HealthyPeople.gov, https://healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health (last visited June
8, 2022).
\128\ Id.; see also Bianca D.M. Wilson et al., The Williams
Inst., UCLA Sch. of Law, Racial Differences Among LGBT Adults in the
US: LGBT Well-Being at the Intersection of Race (2022), https://williamsinstitute.law.ucla.edu/wp-content/uploads/LGBT-Race-Comparison-Jan-2022.pdf.
\129\ Sharita Gruberg et al., Ctr. for Am. Progress, The State
of the LGBTQ Community in 2020 (2020), https://www.americanprogress.org/issues/lgbtq-rights/reports/2020/10/06/491052/state-lgbtq-community-2020/.
\130\ Sandy E. James et al., Nat'l Ctr. for Transgender
Equality, The Report of the 2015 U.S. Transgender Survey, p. 97
(2016), https://transequality.org/sites/default/files/docs/usts/USTS-Full-Report-Dec17.pdf.
---------------------------------------------------------------------------
With respect to transgender individuals, the Department believes
that it is particularly important to acknowledge that evidence
demonstrates that some health care providers have discriminated against
and continue to discriminate against transgender people based on their
gender identities. Transgender people commonly report that their
providers asked them unnecessarily invasive questions about their
gender identity; were physically or verbally abusive; refused them
gender-affirming care; or refused to see them at all due to their
gender identity.\131\ In some cases, transgender people and their
providers face discriminatory obstacles at the hospitals or health
systems where those providers work or have admitting privileges.\132\
Fear of disrespect and discrimination leads many LGBTQI+ people to
report delaying or forgoing needed health care, especially for those
who identify as transgender.\133\ While there is less published
research addressing discrimination and disparate health outcomes in
individuals with intersex conditions, preliminary studies suggest many
of the same concerns and disparities apply.\134\
---------------------------------------------------------------------------
\131\ Id. at pp. 96-97.
\132\ See, e.g., Chico Harlan, A Small-Town Doctor Wanted to
Perform Surgeries for Transgender Women. He Faced an Uphill Battle,
Wash. Post (Nov. 11, 2017), https://www.washingtonpost.com/national/a-small-town-doctor-wanted-to-perform-surgeries-for-transgender-women-he-faced-an-uphill-battle/2017/11/11/c6073a0a-c3d7-11e7-84bc-5e285c7f4512_story.html.
\133\ Patterson, supra note 123, at p. 292.
\134\ Laetitia Zeeman & Kay Aranda, A Systematic Review of the
Health and Healthcare Inequalities for People with Intersex
Variance, 17 Int'l J. of Envtl. Res. & Pub. Health 6533 (2020),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559554/; Amy
Rosenwohl-Mack et al., A National Study on the Physical and Mental
Health of Intersex Adults in the U.S., 15 PLoS ONE, Oct. 9, 2020,
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0240088.
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LGBTQI+ people also face barriers to obtaining health insurance,
which can impact their access to appropriate health care. Insured rates
for LGB+ people have risen substantially since the implementation of
the ACA coverage expansions, yet research indicates that some of these
gains in coverage were lost between 2016 and 2019.\135\ Although
research suggests that transgender people have benefited from the ACA's
coverage expansions and consumer protections,\136\ significant
disparities persist in the uninsured rate for transgender people when
compared to cisgender \137\ people. Nearly one in five transgender
adults reported that they lacked insurance from 2017-2018.\138\
Furthermore, transgender people who can access insurance may
nonetheless be denied coverage for needed services, including gender-
affirming care.\139\ For example, more than 40 percent of transgender
respondents in one survey said their health insurance company denied
them coverage for a gender-affirming surgery; a similar proportion
reported that they were denied coverage for hormone therapy.\140\
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\135\ U.S. Dep't of Health & Human Servs., Assistant Sec'y for
Policy & Evaluation, Office of Health Policy, Issue Brief: Health
Insurance Coverage and Access to Care for LGBTQ+ Individuals:
Current Trends and Key Challenges, p. 4 (June 2021), https://aspe.hhs.gov/sites/default/files/2021-07/lgbt-health-ib.pdf.
\136\ Gruberg, supra note 129.
\137\ The term ``cisgender'' refers to a person whose gender
identity is the same as the person's assigned sex at birth.
\138\ Wyatt Koma et al., The Kaiser Family Found., Demographics,
Insurance Coverage, and Access to Care Among Transgender Adults
(2020), https://www.kff.org/health-reform/issue-brief/demographics-insurance-coverage-and-access-to-care-among-transgender-adults/.
\139\ For purposes of this preamble, the term ``gender-affirming
care'' refers to care for transgender individuals (including those
who identify using other terms, for example, nonbinary or gender
nonconforming) that may include, but is not necessarily limited to,
counseling, hormone therapy, surgery, and other services designed to
treat gender dysphoria or support gender affirmation or transition.
Gender-affirming care may also be, but is not necessarily, referred
to as ``gender-affirming health services'' or ``transition-related
care.'' The terms ``gender-affirming care'' or ``transition-related
care'' also include care sought by individuals with intersex
conditions who seek treatment for gender dysphoria. See World Prof.
Ass'n for Transgender Health, Standards of Care for the Health of
Transsexual, Transgender, and Gender-Nonconforming People, pp. 68-71
(7th Version 2012) [hereinafter WPATH Standards], https://www.wpath.org/media/cms/Documents/SOC%20v7/SOC%20V7_English2012.pdf?_t=1613669341 (last visited Feb. 7, 2022).
\140\ Gruberg, supra note 129.
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Recent research confirms that the COVID-19 pandemic has also
exacerbated the health disparities identified above for LGBTQI+ people.
Specifically, LGBTQ+ people, who have a higher prevalence of underlying
health conditions, are more susceptible to COVID-related illnesses and
death.\141\ Another study revealed that LGBT+ people, in general, have
experienced increased negative mental health impacts during the COVID-
19 pandemic compared with non-LGBT+ people.\142\ LGBTQ+ youth, in
particular, may have experienced increased negative mental health
impacts during the pandemic based on increased feelings of isolation
and the inability to access supportive community groups and LGBTQ+
friendly spaces resulting from stay-at-home orders and social
distancing
[[Page 47835]]
recommendations.\143\ These youth may also face familial rejection and
related mental health and other consequences.\144\ Compared to non-
LGBT+ people, larger shares of LGBT+ people reported COVID-related
employment disruptions.\145\ Thus, accessing and affording mental
health care \146\ and health insurance generally \147\ during the
pandemic is disproportionally more difficult for LGBT+ people compared
to their numbers in the general population.
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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,
www.sciencedirect.com/science/article/pii/S0165178122000051.
\142\ Lindsey Dawson et al., Kaiser Family Found., The Impact of
the COVID-19 Pandemic on LGBT+ People's Mental Health (2021),
https://www.kff.org/other/issue-brief/the-impact-of-the-covid-19-
pandemic-on-lgbt-peoples-mental-health/
#:~:text=LGBT%20people%20reported%20the%20COVID,rates%20than%20non%2D
LGBT%20people.
\143\ Ishaan Sachdeva et al., Letter to the Editor: The
Disparities Faced by the LGBTQ+ Community in Times of COVID-19, 297
Elsevier Psychiatry Res., Jan. 14, 2021, https://www.sciencedirect.com/science/article/pii/S0165178121000226; Laurie
A. Drabble & Michael J. Eliason, Introduction to Special Issue:
Impacts of the COVID-19 Pandemic on LGBTQ+ Health and Well-Being, 68
J. Homosexuality 545, 549 (2021), https://www.tandfonline.com/doi/pdf/10.1080/00918369.2020.1868182?needAccess=true; Scott Emory Moore
et al., Disproportionate Impact of the COVID-19 Pandemic on
Perceived Social Support, Mental Health and Somatic Symptoms in
Sexual and Gender Minority Populations, 68 J. Homosexuality 577, 587
(2021), www.tandfonline.com/doi/full/10.1080/00918369.2020.1868184.
\144\ Sachdeva, supra note 143.
\145\ Dawson, supra note 142.
\146\ Nowaskie, supra note 141, at p. 3; see also Brad Sears et
al., Williams Inst., UCLA Sch. of L., The Impact of the Fall 2020
COVID-19 Surge on LGBT Adults in the U.S., p. 10 (2021), https://williamsinstitute.law.ucla.edu/wp-content/uploads/COVID-LGBT-Fall-Surge-Feb-2021.pdf.
\147\ Drabble, supra note 143, at 548.
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3. Health Equity and Discrimination Related to Age
Although the health disparities discussed above exist in all age
groups, older adults experience unique age-related discrimination that
negatively impacts their health. There is evidence that age
discrimination has negative effects on the physical and mental health
of older adults,\148\ including fatigue, pain, cognitive impairment,
depression, and anxiety.\149\ Older adults have reported discrimination
including providers disregarding their knowledge of their own health
care needs, having their pain ignored for prolonged periods of time,
and providers assuming that as older adults they are cognitively
compromised or unable to communicate their medical concerns.\150\ Some
older adults also report being disrespected, rushed, and ignored by
their health care providers.\151\ One study on age discrimination found
that one in 17 adults over the age of 50 experience frequent age
discrimination in health care settings, and this is associated with a
new or worsened disability within four years.\152\
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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), https://doi.org/10.2105/AJPH.2019.305123.
\149\ Why Ageism in Health Care Is a Growing Concern,
RegisCollege.edu, https://online.regiscollege.edu/blog/why-ageism-in-health-care-is-a-growing-concern/ (last visited Apr. 20, 2022).
\150\ Judith Graham, `They Treat Me Like I'm Old and Stupid':
Seniors Decry Health Providers' Age Bias, Kaiser Health News (Oct.
20, 2021), https://khn.org/news/article/ageism-health-care-seniors-decry-bias-inappropriate-treatment/.
\151\ Id.
\152\ Stephanie E. Rogers et al., Discrimination in Healthcare
Settings is Associated with Disability in Older Adults: Health and
Retirement Study, 2008-2012, 30 J. Gen. Intern. Med., 1413, 1420
(2015), https://doi.org/10.1007/s11606-015-3233-6.
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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, https://www.cdc.gov/nchs/covid19/mortality-overview.htm (last visited Feb. 16, 2022).
\154\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare &
Medicaid Servs., The Impact of COVID-19 on Medicare Beneficiaries in
Nursing Homes, https://www.cms.gov/medicare-covid-19-nursing-home-analysis (last visited Mar. 15, 2022).
\155\ Id.
\156\ Id.
\157\ Id.
\158\ See, e.g., Fangli Geng et al., Daily Nursing Home Staffing
Levels Highly Variable, Often Below CMS Expectations, 38 Health
Affairs 1095, 1099 (2019), https://doi.org/10.1377/hlthaff.2018.05322.
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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), https://doi.org/10.26099/yffm-2x15.
\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, https://www.cdc.gov/aging/publications/features/Alz-Greater-Risk.html (last visited Mar. 15, 2022).
\163\ Id.
\164\ Alzheimer's Ass'n, Special Report: Race, Ethnicity and
Alzheimer's in America, p. 72 (2021), https://www.alz.org/media/Documents/alzheimers-facts-and-figures-special-report.pdf.
\165\ Id.
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[[Page 47836]]
Another age group disadvantaged by health disparities is children.
Social determinants of health such as racism and poverty have been
shown to have profoundly negative effects on the health status of
children and adolescents. Research on the relationship between the
impact of racism and the biological effects of chronic exposure to
stress hormones at the cellular level reveals links between birth
disparities and mental health challenges in youth.\166\
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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,
https://publications.aap.org/pediatrics/article/144/2/e20191765/38466/The-Impact-of-Racism-on-Child-and-Adolescent.
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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), https://www.ncbi.nlm.nih.gov/books/NBK44192/pdf/Bookshelf_NBK44192.pdf.
\168\ Health Effects of Lead Exposure, U.S. Dep't of Health &
Human Servs., Ctrs. for Disease Control & Prevention, https://www.cdc.gov/nceh/lead/prevention/health-effects.htm (last visited
Mar. 15, 2022).
\169\ See, e.g., Eric M. Roberts et al., Assessing Child Lead
Poisoning Case Ascertainment in the US, 1999-2010, 139 Pediatrics,
May 2017, https://publications.aap.org/pediatrics/article/139/5/e20164266/38761/Assessing-Child-Lead-Poisoning-Case-Ascertainment;
Who is Vulnerable to Childhood Lead Poisoning, Tracking California,
https://www.trackingcalifornia.org/childhood-lead-poisoning/who-is-vulnerable-to-childhood-lead-poisoning (last visited Mar. 15, 2022).
\170\ See, e.g., Roberts, supra note 169; Who is Vulnerable to
Childhood Lead Poisoning, supra note 169.
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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), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5302214/; Gloria L. Krahn et
al., Persons with Disabilities as an Unrecognized Health Disparity
Population, 205 Am. J. Pub. Health S198 (Apr. 2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4355692/; 2020 Topics and
Objectives: Disability and Health, HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health (last visited Nov. 10, 2021); Elham Mahmoudi & Michelle
Meade, Disparities in Access to Health Care Among Adults with
Physical Disabilities: Analysis of a Representative National Sample
for a Ten-Year Period, 8 Disability Health J. 182 (2015), https://pubmed.ncbi.nlm.nih.gov/25263459/.
\172\ Debra L. Brucker & Andrew J. Houtenville, People with
Disabilities in the United States, 96 Archives of Physical Medicine
and Rehabilitation 771 (2015), https://doi.org/10.1016/j.apmr.2015.02.024.
\173\ Nat'l Council on Disability, Enforceable Accessible
Medical Equipment Standards: A Necessary Means to Address the Health
Care Needs of People with Mobility Disabilities, p. 7 (2021),
https://ncd.gov/sites/default/files/Documents/NCD_Medical_Equipment_Report_508.pdf.
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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),
https://www.healthaffairs.org/doi/10.1377/hlthaff.2020.01452. See
also, Lisa I. Iezzoni et al., US Physicians' Knowledge About the
Americans with Disabilities Act and Accommodation of Patients with
Disability, 41 Health Affairs 96 (2022), https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2021.01136.
\175\ Kenneth A. Gerhart et al., Quality of Life Following
Spinal Cord Injury: Knowledge of Attitudes of Emergency Care
Providers, 24 Annals of Emergency Med. 807 (1994), https://www.annemergmed.com/article/S0196-0644(94)70318-3/fulltext; David
Carlson et al., Nat'l Disability Rights Network, Devaluing People
with Disabilities: Medical Procedures that Violate Civil Rights, pp.
17, 23, 28, 42-43, 49, 54 (2012), https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf; Laura
VanPuymbrouck et al., Explicit and Implicit Disability Attitudes of
Healthcare Providers, 65 Rehab. Psychology 101 (2020), https://pubmed.ncbi.nlm.nih.gov/32105109/.
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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), https://www.healthaffairs.org/do/10.1377/hblog20210325.480382/full/.
\177\ 2020 Topics and Objectives: Disability and Health,
HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/disability-and-health (last visited Nov. 10, 2021).
\178\ Kenton J. Johnson et al., Ambulatory Care Access and
Emergency Department Use for Medicare Beneficiaries With and Without
Disabilities, 40 Health Affairs 910 (2021), https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.01891.
\179\ Id.
\180\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare &
Medicaid Servs., Medicare Current Beneficiary Survey (2013), https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Data-Highlight-ADA-2017.pdf.
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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), https://doi.org/10.1089/jwh.2020.8864.
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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),
https://doi.org/10.1016/j.dhjo.2021.101103.
\183\ U.S. Dep't of Health & Human Servs. & U.S. Dep't of
Justice, Guidance on ``Long Covid'' as a Disability Under the ADA,
Section 504, and Section 1557 (July 26, 2022), https://www.hhs.gov/about/news/2021/07/26/hhs-doj-issue-guidance-on-long-covid-and-disability-rights.html.
\184\ Civil Rights and COVID-19, U.S. Dep't of Health & Human
Servs., Office for Civil Rights, https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/ (last updated July 26,
2021); Bulletin, U.S. Dep't of Health & Human Servs., Office for
Civil Rights, Civil Rights, HIPAA, and the Coronavirus Disease 2019
(Mar. 28, 2020), https://www.hhs.gov/sites/default/files/ocr-bulletin-3-28-20.pdf.
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5. Improving the Nation's Health Through Civil Rights Protections
The Department is committed to doing its part to address health
disparities and to promote equity in health care access through a range
of initiatives, including through implementation and enforcement of
Section 1557's protections. As reviewed above, the 2016 Rule provided
clarity regarding Section 1557's strong statutory protections from
discrimination and equipped the Department with the means to enforce
these protections. The 2020 Rule, by contrast, limited the Rule's
scope, removed principal provisions from the Section 1557 regulation,
and left ambiguity regarding the extent of various protections. The
2020 Rule removed specific provisions implementing nondiscrimination
protections regarding gender identity. The 2020 Rule also eliminated
specific provisions addressing discrimination in health insurance
coverage benefit design and eliminated provisions designed to ensure
access to language assistance services for LEP individuals.
Furthermore, 2020 Rule also narrowed the regulation's application to
some, but not all, operations of health insurance issuers and to only
certain programs administered by the Department.
The 2020 Rule's removal of specific nondiscrimination provisions
from the Section 1557 regulation--including the provision implementing
protections based on gender identity discrimination, as well as other
changes that could be read to limit the reach of Section 1557--has the
potential to increase the incidence of discrimination for groups
protected under the statute. As described above, discrimination leads
to negative impacts on access to care and mental and physical health
outcomes. An increase in discrimination will widen existing disparities
and harm the well-being of underserved and historically marginalized
individuals and communities. The Department acknowledges the potential
interest that covered entities and other stakeholders may have in
maintaining the 2020 Rule and recognizes that some of the proposed
revisions reflect changes to certain positions articulated in that
Rule. However, the Department is also cognizant of the fact that absent
revisions to the 2020 Rule, protected groups likely will be relegated
to inferior health care access without strong civil rights protections
at a moment when health disparities have been magnified by the unequal
burden of the COVID-19 pandemic.
III. Nondiscrimination in Health Programs and Activities
Subpart A--General Provisions
Purpose and effective date (Sec. 92.1)
Proposed Sec. 92.1(a) states that the purpose of this part is to
implement Section 1557, which prohibits discrimination in certain
health programs and activities on the grounds prohibited under Title
VI, Title IX, the Age Act, or Section 504. As discussed further in the
Preamble's discussion of proposed Sec. 92.2, HHS interprets Section
1557's prohibition of discrimination on the ``ground[s] prohibited''
under Title VI, Title IX, Age Act, or Section 504 to mean that Section
1557 prohibits discrimination based on race, color, national origin,
sex, age, or disability.\185\ In addition to incorporating the
``ground[s] prohibited'' by these other statutes, Section 1557
incorporates the ``enforcement mechanisms'' of the statutes.\186\
Though the Section 1557 rule is informed by the Title VI, Title IX, Age
Act, and Section 504 implementing regulations, Section 1557 provides an
independent basis for regulation of discrimination in covered health
programs and activities that is distinct from Title VI, Title IX, the
Age Act, and Section 504. Section 1557's nondiscrimination requirements
do not in any way limit or impact the interpretation of those
statutes.\187\
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\185\ See Schmitt v. Kaiser Found. Health Plan of Wash., 965
F.3d 945, 953 (9th Cir. 2020) (``Section 1557(a) incorporates only
the prohibited `grounds' and `the mechanisms provided for and
available under' the four civil rights statutes. A prohibited
`ground' for discrimination . . . is simply the protected
classification at issue.'').
\186\ 42 U.S.C. 18116(a).
\187\ See id. 18116(b).
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Section 92.1(b) proposes that the effective date of the Section
1557 implementing regulation shall be 60 days after the publication of
a final rule in the Federal Register. This section provides an
exception to the start date for provisions of this part that require
changes to health insurance or group health plan benefit design. Such
provisions will have a delayed implementation date of the first day of
the first plan year (in the individual market, policy year) beginning
on or after the year immediately following the effective date of the
Final Rule in the Federal Register. This delayed implementation will
allow covered entities to revise their health insurance coverage or
other health-related coverage to comply with the regulation and to
avoid administrative challenges associated with applying the Final
Rule's requirements in the middle of a plan year or policy year. We
seek
[[Page 47838]]
comments from issuers, employers, and other plan sponsors on how long
they anticipate it would take to adjust their plan offerings, and from
Exchanges on how long they would need to implement the proposed
requirements.
Application (Sec. 92.2)
Proposed Sec. 92.2 addresses the application of this regulation.
The Department proposes in Sec. 92.2(a) to apply the rule, except as
otherwise provided in this part, to: (1) every health program or
activity, any part of which receives Federal financial assistance,
directly or indirectly, from the Department; (2) every health program
or activity administered by the Department; and (3) every program or
activity administered by a Title I entity.
Paragraph (a)(1) proposes to make the rule applicable to every
health program or activity, any part of which receives Federal
financial assistance, directly or indirectly, from the Department.
In paragraph (a)(2), we propose to apply the rule to all health
programs and activities of the Department. This is consistent with the
2016 Rule, and in contrast to the 2020 Rule, which only applies to
those programs and activities administered by the Department under
Title I of the ACA. The statute prohibits discrimination on the
enumerated bases in ``any program or activity that is administered by
an Executive Agency or any entity established under this title.'' \188\
The operative word, ``or,'' distinguishes programs and activities
operated by an Executive Agency from those operated by a Title I
entity. Although the 2020 Rule construes this language to cover only
programs and activities administered by the Department under Title I of
the ACA and programs and activities administered by any entity
established under Title I of the ACA, upon further review the
Department finds this reading of the statute unpersuasive. We do not
believe that the best way to resolve any perceived ambiguity is to
construe the phrase ``established under this title'' as modifying the
phrase ``administered by an Executive Agency.''
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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), https://www.census.gov/content/dam/Census/library/publications/2020/demo/p60-271.pdf.
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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\
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\211\ 85 FR at 37208.
\212\ 42 U.S.C. 18116(a).
---------------------------------------------------------------------------
Section 1557's structure confirms that textual understanding. The
statute explicitly incorporates ``[t]he enforcement mechanisms provided
for and available under'' the referenced statutes.\213\ That provision
demonstrates that when Congress wanted to incorporate aspects of the
referenced statutes other than the ``grounds'' of prohibited
discrimination, it did so expressly. There is, by contrast, no such
express incorporation of the Title IX exceptions. To the contrary, the
very first words of Section 1557 are that ``[e]xcept as otherwise
provided for in this title (or an amendment made by this title), an
individual shall not, on the ground prohibited under [the four
referenced statutes], be excluded from participation in, be denied the
benefits of, or be subjected to discrimination under, any health
program or activity, any part of which is receiving Federal financial
assistance . . .'' \214\ Congress, in other words, specifically
signaled that the only ``except[ions]'' to Section 1557's prohibition
would be those ``provided for'' or ``made by'' Title I of the ACA,
which does not encompass Title IX of the Education Amendments of 1972.
---------------------------------------------------------------------------
\213\ Id. Sec. 18116.
\214\ Id. 18116(a) (emphasis added).
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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, https://pubmed.ncbi.nlm.nih.gov/31880794/ (discussing
growing religious ownership of health care entities in the context
of whether U.S. adults consider religious affiliation when selecting
health care facilities); Michael Booth, SCL Health to Merge with
Intermountain Health, Creating Not-For-Profit Hospital Giant in
West, The Colorado Sun (Sept. 16, 2021), https://coloradosun.com/2021/09/16/hospital-merger-scl-health-colorado/.
\217\ See, e.g., Coleman Drake et al., Market Share of US
Catholic Hospitals and Associated Geographic Network Access to
Reproductive Health Services, Jama Network Open, Jan. 29, 2020,
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2759762
(research study examining the impact and growth of Catholic health
care entities on the provision of reproductive health care in the
United States); Harris Meyer, Most Catholic Hospitals Don't Disclose
Religious Care Restrictions, Modern Healthcare, Mar. 15, 2019,
https://www.modernhealthcare.com/operations/most-catholic-hospitals-dont-disclose-religious-care-restrictions.
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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)).
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Applying the existing Federal conscience and religious freedom laws
will allow the Department to address the interests in providing
nondiscriminatory health care and religious or conscience commitments
by applying the legal standards applicable to those conscience and
religious freedom laws. It was reasonable for Congress to rely upon
existing conscience and religious freedom laws to protect religious
exercise and respect conscience in appropriate cases, rather than to
import the Title IX religious exception \219\ into Section 1557.
---------------------------------------------------------------------------
\219\ A religiously controlled covered entity that operates an
education program or activity that is entitled to a religious
exemption under Title IX would follow the Department's Title IX
regulation at 45 CFR 86.12.
---------------------------------------------------------------------------
We seek comment on the approach proposed in this NPRM and
particularly invite comments from covered entities controlled by or
affiliated with religious organizations; providers employed by such
entities; and people who receive health care from religiously
affiliated medical providers and entities.
Relationship to Other Laws (Sec. 92.3)
Proposed Sec. 92.3 explains the relationship of the proposed
regulation to existing laws. Paragraph (a) provides that Section 1557
is not intended to apply lesser standards for the protection of
individuals from discrimination than the standards under Title VI,
Title IX, Section 504, the Age Act, or the regulations issued pursuant
to those laws.
Consistent with the statute, paragraph (b)(1) states that nothing
in this part shall be interpreted to invalidate or limit the existing
rights, remedies, procedures, or legal standards available to
individuals aggrieved under the Federal civil rights laws cited in 42
U.S.C. 18116(b) (Title VI, Title VII, Title IX, Section 504, and the
Age Act).
We note here that Title II of the Americans with Disabilities Act
\220\ (ADA) prohibits discrimination on the basis of disability by
public entities (i.e., State and local governments and their agencies)
and is modeled on Section 504.\221\ Title II of the ADA and Section 504
are generally understood to impose substantially the same requirements,
given that Congress enacted the ADA to extend Section 504's existing
protections beyond Executive Agencies and recipients of Federal
funds,\222\ and the Congressional directive that the ADA be construed
to grant at least as much protection as provided by Section 504 and the
regulation implementing Section 504.\223\ Following the passage of the
ADA, the Rehabilitation Act Amendments of 1992 revised the
Rehabilitation Act's findings, purpose, and policy provisions to
incorporate language acknowledging the discriminatory barriers faced by
individuals with disabilities, and to recognize that individuals with
disabilities have the right to ``enjoy full inclusion and integration
in the economic, political, social, cultural and educational mainstream
of American society.'' \224\ The Senate Report concerning the
Rehabilitation Act Amendments of 1992 states that the purpose and
policy statement is ``a reaffirmation of the precepts of the Americans
with Disabilities Act'' and that these principles are intended to guide
the Rehabilitation Act's policies, practices, and procedures.\225\
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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).
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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.
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\235\ 28 CFR 35.104.
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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).
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We propose to include a clause to clarify the Federal financial
assistance
[[Page 47843]]
includes Federal financial assistance that the Department plays a role
in providing or administering. This includes advance payments of the
premium tax credit and cost-sharing reduction payments under Title I of
the ACA, as well as payments, subsidies, or other funds extended by the
Department. This is similar to, but differs slightly from, the 2016
Rule by clarifying that the Federal financial assistance that the
Department plays a role in providing or administering includes the
``advance payments of the premium tax credit and cost-sharing reduction
payments,'' which are the relevant credit and subsidy payments under
Title I of the ACA that the Department plays a role in providing or
administering. The language in this provision was informed by the
definition of ``Federal financial assistance'' in the regulation
implementing Title IX at 45 CFR 86.2(g). That Title IX regulatory
provision clarifies that Federal financial assistance includes wages,
loans, grants, scholarships, and other monies that are given to any
entity for payment to or on behalf of students who are admitted to that
entity or that are given directly to these students for payment to that
entity.\238\
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\238\ 45 CFR 86.2(g)(1)(ii).
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In the health care context, Federal funds are provided on behalf of
eligible individuals for advance payments of the premium tax credit and
cost-sharing reductions (also referred to as cost-sharing subsidies) to
ensure the affordability of health insurance coverage purchased through
the Health Insurance Exchanges. As in the 2016 Rule, we have added
language to this proposed definition stating that such funds, as well
as payments, subsidies, or other funds extended by the Department, are
Federal financial assistance covered by the Rule when extended to the
entity providing the health insurance coverage or services, whether
they are paid directly by the Federal Government to that entity or to
the individual for payment to the entity providing health insurance
coverage or services. Thus, an issuer participating in any Health
Insurance Exchange is receiving Federal financial assistance when
advance payments of the premium tax credit or cost-sharing subsidies
are provided on behalf of any of the issuer's enrollees. A health
services provider that contracts with such an issuer does not become a
recipient of Federal financial assistance by virtue of the contract but
would be a recipient if the provider otherwise receives Federal
financial assistance, such as through participation in Medicare or
Medicaid.
The 2020 Rule did not include language regarding Federal financial
assistance that the Department plays a role in providing or
administering. The Department asserted in the preamble of the 2020 Rule
that the 2016 definition was overbroad. This interpretation fails to
consider the statutory language of Section 1557, which specifically
includes ``credits'' and ``subsidies'' as Federal financial assistance,
in conjunction with the entirety of Title I of the ACA, which
specifically grants the Secretary clear authority over the programs for
which the Department plays a role in providing or administering Federal
financial assistance. These Title I programs include the advance
payments of the premium tax credit and cost-sharing reductions,\239\ as
well as pass-through funding available to states through section 1332
waivers.\240\
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\239\ Section 1412 of the ACA, codified at 42 U.S.C. 18082.
\240\ Section 1332(a)(3) of the ACA, codified at 42 U.S.C.
18052(a)(3).
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The Department plays a role in providing or administering advance
payments of the premium tax credit and cost-sharing reductions as set
forth in Title I of the ACA, which specifies that the Secretary of HHS,
``in consultation with the Secretary of the Treasury, shall establish a
program'' for advance payments of the premium tax credit and cost-
sharing reductions.\241\ HHS advises the Department of the Treasury of
the amounts of advance payments of the premium tax credit and cost-
sharing reductions and works with Department of the Treasury to make
payments to issuers.\242\
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\241\ Section 1412 (a)-(c) of the ACA, codified at 42 U.S.C.
18082(a)-(c).
\242\ Id.
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The Department notes that it is not currently making cost-sharing
reduction payments to issuers. On October 11, 2017, the Attorney
General issued a legal opinion that HHS did not have a valid
appropriation with which to make cost-sharing reduction payments to
issuers.\243\ As a result, the cost-sharing reduction payments ceased
as of October 12, 2017.\244\ If issuers receive cost-sharing reduction
payments in the future from the Department, such payments would be
considered Federal financial assistance under this proposed rule
similar to the advance payments of the premium tax credit.
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\243\ Memorandum from Eric Hargan, Acting Sec'y, Dep't of Health
& Human Servs., to Seema Verma, Admin'r, Ctrs. for Medicare &
Medicaid Servs. (enclosing Attorney General Jeff Sessions' legal
opinion, dated October 11, 2017, regarding cost-sharing reduction
payments) (Oct. 12, 2017), https://www.hhs.gov/sites/default/files/csr-payment-memo.pdf.
\244\ Id.
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Similarly, the Department plays a role in providing or
administering pass-through funding available to states through section
1332 waivers.\245\ Section 1332 of the ACA provides that states may
apply to the Department of Health and Human Services and the Department
of the Treasury for waivers of certain ACA requirements in the
individual and small group markets if the waiver satisfies certain
statutory requirements.\246\ Section 1332(a)(3) of the ACA directs the
Department of Health and Human Services and the Department of the
Treasury to pay pass-through funding to the state for the purpose of
implementing the state section 1332 waiver plan and outlines
accompanying requirements for making the pass-through funding
determination.\247\ The amount of Federal pass-through funding is equal
to the amount, determined annually by the Department of Health and
Human Services and the Department of the Treasury, of the premium tax
credit under section 36B of the Internal Revenue Code, the small
business tax credit under section 45R of the Internal Revenue Code, or
cost-sharing reductions under ACA Title I, part I of subtitle E, that
individuals and small employers in the state would otherwise be
eligible for had the state not received approval for its section 1332
waiver. This calculation includes any amount not paid due to an
individual or small employer not qualifying for the premium tax credit,
small business tax credit, or cost-sharing reductions or qualifying for
a reduced level of such financial assistance.\248\
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\245\ Section 1332(a)(3) of the ACA, codified at 42 U.S.C.
18052(a)(3).
\246\ Section 1332(a) of the ACA, codified at 42 U.S.C.
18052(a). States with approved waivers have specific terms and
conditions (STCs) that the state must also comply with all
applicable Federal statutes relating to nondiscrimination, including
Section 1557. See e.g., Ctrs. for Medicare & Medicaid Servs.,
approval of Colorado's extension application for a section 1332
State Innovation Waiver, STC 4 (Aug. 13, 2021), https://www.cms.gov/files/document/1332-co-extension-approval-letter-stcs.pdf.
\247\ See Section 1332(a)(3) of the ACA, codified at 42 U.S.C.
18052(a)(3), and implementing regulations at 31 CFR 33.122, 45 CFR
155.1322.
\248\ 31 CFR 33.122; 45 CFR 155.1322; 86 FR 53412 (Sept. 27,
2021).
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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).
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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\
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\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.
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\252\ 81 FR 31385.
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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) Medical history; (6)
Genetic information; (7) Evidence of insurability (including
conditions arising out of acts of domestic violence); (8)
Disability; (9) Any other health status-related factor determined
appropriate by the Secretary).
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By including a nondiscrimination provision in Title I of the ACA, a
title of the health care law that predominantly addresses access to and
the design of health insurance and other health-related coverage,
Congress demonstrated an intent to apply the non-discrimination
provision to health insurance issuers that receive financial support
from the Federal Government. Private health insurance issuers play a
critical role in ensuring that people are able to receive care within
the current health care system. Issuers exercise significant control
over enrollees' ability to access their health care by strongly
influencing which providers they see, which hospitals they visit, and
which treatments or medications they receive.\259\ Indeed, a recent
district court opinion on this issue found that, by virtue of being the
``gatekeeper'' of the plaintiff's health care, a health plan qualified
as a `` `health program' that Congress intended to rid of
discrimination.'' \260\ This proposed rule is consistent with that
reading.
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\259\ Additionally, many health insurance issuers are directly
involved in the provision of care through administration of a health
maintenance organization (HMO). An HMO is a health insurance plan
that usually limits coverage to care from doctors who work for or
contract with the HMO.
\260\ Fain, 545 F. Supp. 3d at 342 (holding that defendant
health plan was a ``health program or activity'' for purposes of
Section 1557 jurisdiction).
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We note that the 2016 Rule included group health plans \261\ as
among the entities that were categorically covered for all of their
operations. We propose to not explicitly include group health plans in
the non-exhaustive list of entities identified in proposed paragraph
(b). Although we still consider group health plans to be principally
engaged in providing or administering health programs or activities
described in paragraph (a), many group health plans themselves are not
recipients of Federal financial assistance (as opposed to the employer
or plan sponsor offering the group health plan or the third party
administrator administering the group health plan), so inclusion of
group health plans on the list may be confusing. That said, if the
Department receives a complaint against a group health plan, we will
evaluate the facts on a case-by-case basis to determine whether the
group health plan is a covered entity subject to this part.
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\261\ ``Group health plan'' is defined as ``an employee welfare
benefit plan to the extent that the plan provides medical care (as
defined in paragraph (2) and including items and services paid for
as medical care) to employees or their dependents (as defined under
the terms of the plan) directly or through insurance, reimbursement,
or otherwise. Such term shall not include any qualified small
employer health reimbursement arrangement (as defined in section
9831(d)(2) of Title 26).'' 29 U.S.C. 1191b(a)(1); see also 42 U.S.C.
300gg-91(a). ``Employee welfare benefit plan'' is defined as ``any
plan, fund, or program which was heretofore or is hereafter
established or maintained by an employer or by an employee
organization, or by both, to the extent that such plan, fund, or
program was established or is maintained for the purpose of
providing for its participants or their beneficiaries, through the
purchase of insurance or otherwise, (A) medical, surgical, or
hospital care or benefits, or benefits in the event of sickness,
accident, disability, death or unemployment, or vacation benefits,
apprenticeship or other training programs, or day care centers,
scholarship funds, or prepaid legal services, or (B) any benefit
described in section 186(c) of this title (other than pensions on
retirement or death, and insurance to provide such pensions).'' 29
U.S.C. 1002(1).
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We note that even if the Department determines that a group health
plan is not covered under this part, other entities that contract with
a group health plan or a sponsor of a group health plan may be covered
entities. For example, recipient health insurance issuers principally
engaged in providing or administering health insurance coverage would
be covered for health insurance they provide to a fully-insured group
health plan and also for third party administrator activities that they
are responsible \262\ for providing in a self-funded group health
plan.\263\ The Department will evaluate the facts on a case-by-case
basis to determine whether other entities that contract with a group
health plan are covered entities subject to this part. Further, though
a group health plan may not be covered under Section 1557, it may still
be subject to other Federal nondiscrimination requirements. For
example, group health plans and health insurance issuers offering non-
grandfathered group or individual health insurance coverage are
prohibited from establishing any rule for eligibility, benefits, or
premiums or contributions that discriminates based on any health
factor.\264\
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\262\ See, e.g., Tovar v. Essentia Health, 857 F.3d 771, 778
(8th Cir. 2017) (holding that a third party administrator could be
liable under Section 1557 for damages arising from discriminatory
terms in a self-funded employer-provided health plan if the third
party administrator provided the employer with a discriminatory plan
document, notwithstanding the fact that the employer subsequently
adopted the plan and maintained control over its terms).
\263\ See discussion infra under proposed Sec. 92.207 on
application to third party administrators.
\264\ 45 CFR 147.110 (HHS); 29 CFR 2590.715-2705 (Department of
Labor); 26 CFR 54.9815-2705 (Department of the Treasury). We note
that grandfathered and non-grandfathered group health plans and
health insurance issuers offering health insurance coverage in
connection with a group health plan are prohibited from establishing
any rule for eligibility, benefits, or premiums or contributions
that discriminates based on any health factor pursuant to 45 CFR
146.121 (HHS); 29 CFR 2590.702 (Department of Labor); 26 CFR
54.9802-1 (Department of the Treasury).
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We seek comment on the circumstances under which a group health
plan might receive funds that could be considered Federal financial
assistance from the Department, including the type and prevalence of
funds received that could be considered Federal financial assistance
under this part.
Finally, we emphasize that proposed paragraph (b) is not intended
to serve as an exhaustive list of those entities HHS believes would
qualify as principally engaged in the provision or administration of
health programs or activities described in paragraph (a). For example,
we propose to expressly refer to hospitals but not to refer to other
common names, such as medical centers, for the same or similar
entities. Similarly, we propose not to expressly include hospital
systems or healthcare systems, even though in many instances they will
fall within the scope of
[[Page 47846]]
paragraph (b). For example, under proposed (b), the rule could cover
all of the operations of a non-profit healthcare system operating five
hospitals, depending on the specific facts. HHS will evaluate the
facts, on a case-by-case basis, to determine whether an entity falls
within the scope of paragraph (b)'s categorical coverage. We invite
comments on whether it is important to add any other entities to the
list in (b) in order to further clarify coverage.
Machine translation. We propose to define ``machine translation''
as automated translations, without the assistance of or review by a
qualified human translator, that are text-based and provide instant
translations between various languages, sometimes with an option for
audio input or output. This is in contrast to human translation, which
is context-based and captures the intended meaning of the source. This
definition is based on literature addressing the use of machine
translation in the clinical setting, which we believe captures the
automated translations that are being used in the health care
setting.\265\ We seek comment on the adequacy of this definition.
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\265\ Gudeeshpal Randhawa et al., Using Machine Translation in
Clinical Practice, 59 Can. Fam. Physician 328 (2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3625087/pdf/0590382.pdf.
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Assurances Required (Sec. 92.5)
This proposed rule would retain the requirement of the 2016 and
2020 Rules for recipients to submit assurances of compliance to the
Department. One method that the Federal Government uses to ensure civil
rights compliance is to require covered entities to submit assurances
of compliance when applying for Federal financial assistance. The
assurances and related certification documents remind covered entities
of their civil rights obligations and can also assist the Department in
pursuing an independent contract claim for enforcement of
nondiscrimination requirements.\266\
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\266\ See, e.g., Dep't of Justice, Guidelines for the
Enforcement of Title VI, Civil Rights Act of 1964, 28 CFR 50.3, pt.
I.B.1 (listing various ``[p]ossibilities of judicial enforcement,''
including suits to enforce contractual assurances).
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Specifically, proposed Sec. 92.5 is the same as Sec. 92.4 of the
2020 Rule. In proposed paragraph (a), each entity applying for Federal
financial assistance, each issuer seeking certification to participate
in a Health Insurance Exchange, and each state seeking approval to
operate a State Exchange is required to submit an assurance that its
health programs and activities will be operated in compliance with
Section 1557, Title VI, Title IX, Section 504, and the Age Act. The
duration of obligation (proposed paragraph (b)), and covenants language
(proposed paragraph (c)) adopt the corresponding requirements found in
the Section 504 regulation at 45 CFR 84.5.
Remedial Action and Voluntary Action (Sec. 92.6)
The Department proposes to include requirements regarding remedial
and voluntary action, which would reinstate former Sec. 92.6 in the
2016 Rule. The 2020 Rule repealed former Sec. 92.6, stating that it
was duplicative and overlapped with existing civil rights laws and
regulations, and therefore would cause confusion about the
responsibilities of covered entities.\267\ The regulations implementing
Title IX, Section 504, and the Age Act do require a covered entity to
take voluntary action upon a determination that the entity engaged in
discriminatory conduct.\268\ The Department believes that, rather than
causing confusion, proposed Sec. 92.6 clarifies that Section 1557 also
requires covered entities that have engaged in discriminatory conduct
with respect to their health programs and activities in violation of
this part to take voluntary actions to remediate the effects of such
discriminatory conduct. Where a covered entity is required to take
remedial actions under Title VI, Section 504, Title IX, or the Age Act,
such actions would likely satisfy the remedial actions required by
proposed Sec. 92.6.
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\267\ See 85 FR 37160, 37162 (June 19, 2020).
\268\ 45 CFR 86.3(a)-(b) (Title IX); Sec. 84.6(a)-(b) (Section
504); Sec. 91.48 (Age Act).
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Designation and Responsibilities of a Section 1557 Coordinator (Sec.
92.7)
Proposed Sec. 92.7(a) requires covered entities with 15 or more
employees to designate at least one employee to serve as a Section 1557
coordinator (Section 1557 Coordinator) to coordinate their efforts to
comply with and carry out the covered entity's responsibilities under
Section 1557 and this part with regard to their health programs and
activities. The 2016 Rule similarly required covered entities of this
size to designate a compliance coordinator for Section 1557 at former
Sec. 92.7. We newly propose to permit covered entities to, as
appropriate, assign one or more designees to carry out some of the
responsibilities of the Section 1557 Coordinator. The 2016 Rule did not
include this provision, and we include it here in recognition that some
covered entities may want or need to spread the duties of the Section
1557 Coordinator over multiple staff. However, the Section 1557
Coordinator must retain ultimate oversight for ensuring coordination
with the covered entity's compliance.
In 2020, the Department repealed the requirement for each covered
entity with 15 or more employees to designate a Section 1557
Coordinator or ``designated employee,'' reasoning that to the extent
that the implementing regulations for the referenced statutes ``have
responsible employee and grievance procedures, they are sufficient for
enforcement of Section 1557.'' \269\ We believe that a designated
Section 1557 Coordinator will help ensure covered entities comply with
the requirements of Section 1557. Additionally, a designated Section
1557 Coordinator will better allow covered entities to resolve
potential grievances as accurately and efficiently as possible, to the
benefit of individuals seeking care as well as the covered entity.
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\269\ 85 FR 37204.
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The Department recognizes that covered entities with 15 or more
employees may have retained their Section 1557 Coordinators required by
the 2016 Rule even though the 2020 Rule does not require covered
entities to do so. Under proposed Sec. 92.7, those covered entities
that have retained their Section 1557 Coordinators need not appoint a
new one, though the existing Section 1557 Coordinator would be
responsible for the responsibilities outlined in proposed paragraph
(b).
The implementing regulations for Section 504 and Title IX require
covered entities to designate a responsible employee to coordinate the
covered entity's civil rights compliance, and the Title VI and Age Act
regulations do not explicitly include such a requirement.\270\ A
covered entity that has already designated a responsible employee
pursuant to the Section 504 or Title IX regulations may assign that
individual to coordinate the covered entity's efforts to comply with
Section 1557, provided that the scope of the individual's
responsibilities is modified to include all prohibited bases of
discrimination included in Section 1557 and other duties as required.
Like the 2016 Rule, proposed Sec. 92.7(a) standardizes the requirement
for covered entities that employ more than 15 people to designate a
Section 1557 Coordinator.
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\270\ 45 CFR 84.7(a) (Section 504); Sec. 86.8(a) (Title IX).
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At proposed paragraph (b), we provide a list of responsibilities of
the Section 1557 Coordinator. The 2016 Rule did not include a similar
provision. The Department proposes to
[[Page 47847]]
include a list of responsibilities to assist covered entities in
developing a position description for the Section 1557 Coordinator and
to identify the provisions over which Coordinators must have direct
responsibility. Proposed responsibilities include, at a minimum, that
the covered entity ensure that the Section 1557 Coordinator: (1)
receives, reviews, and processes grievances filed under the grievance
procedure as set forth in proposed Sec. 92.8(c); (2) coordinates the
covered entity's recordkeeping requirements as set forth in proposed
Sec. 92.8(c); (3) coordinates effective implementation of the covered
entity's language access procedures as set forth in proposed Sec.
92.8(d); (4) coordinates effective implementation of the covered
entity's effective communication procedures as set forth in proposed
Sec. 92.8(e); (5) coordinates the covered entity's procedures for
providing reasonable modifications for individuals with disabilities in
accordance with proposed Sec. 92.8(f); and (6) coordinates training of
relevant employees as set forth in proposed Sec. 92.9, including
maintaining the required documentation.
We seek comment on this requirement, including whether OCR should
require covered entities with fewer than 15 employees to designate a
Section 1557 Coordinator and, if so, whether there should be a
requisite number of employees or whether all covered entities should be
required to designate a Section 1557 Coordinator. We are particularly
interested in hearing from smaller covered entities who have a civil
rights coordinator about whether they believe there is a benefit to
having such a dedicated staff member, and any associated costs or
burdens. We further seek comment on whether the enumeration of
responsibilities of the Section 1557 Coordinator is beneficial and
sufficiently comprehensive. We also seek comment on how the Department
can support Section 1557 Coordinators, including through the provision
of training, so that they understand their duties, the protections
afforded by Section 1557, and the rationale for both.
Policies and Procedures (Sec. 92.8)
Proposed Sec. 92.8 would require covered entities to develop and
implement written policies and procedures that are designed to
facilitate compliance with the requirements of this part. The
Department recognizes that, taken alone, the implementing regulations
for the statutes referenced in Section 1557 may require entities to
undertake different processes depending on the alleged basis of
discrimination.
This rulemaking provides for more consistency regardless of whether
an allegation of discrimination in a covered health program or activity
is based on race, color, national origin, sex, age, or disability--or
some combination thereof. The 2020 Rule fails to account for claims of
discrimination in health programs and activities that are alleged to
have occurred based on multiple protected bases. The Department
believes that establishing procedural requirements across
nondiscrimination bases is important because it benefits the public and
covered entities, and it streamlines OCR's enforcement scheme. For the
public, providing consistent regulatory procedural requirements across
nondiscrimination bases recognizes the potential for complaints
alleging discrimination on multiple bases (e.g., sex and race). Covered
entities would gain clarity with respect to their regulatory procedural
requirements without any confusion as to whether different provisions
apply depending on the protected basis. For example, there are
currently questions as to whether or not the 2020 Rule requires covered
entities to have a responsible employee and grievance procedure to
address issues of sex discrimination, or if that is only required to
the extent that it would be required under Title IX (i.e., whether the
health program and activity must also be an education program or
activity to trigger the requirement).
This proposed section would require each covered entity, in its
health programs and activities, to adopt and implement a
nondiscrimination policy, grievance procedures (for covered entities
employing 15 or more persons), language access procedures, auxiliary
aids and services procedures, and procedures for reasonable
modifications for individuals with disabilities (collectively,
``Section 1557 Policies and Procedures''). We recognize that the
covered entities vary significantly in size, nature of business, and
location and accordingly recognize that each covered entity's Section
1557 Policies and Procedures may vary. OCR is committed to supporting
covered entities as they develop policies and procedures and is
planning to provide sample documents on the Department's website. Given
the prevalence of covered entities with fewer than 15 employees that
provide health care services to a significant volume of patients, the
Department highly encourages such covered entities to implement Section
1557 Policies and Procedures based on the sample documents that will be
available on the agency website. The Department underscores that
covered entities with fewer than 15 employees would still be prohibited
from discriminating in health programs and activities under Section
1557, even if those entities are not required to adopt grievance
procedures, or to hire a Section 1557 Coordinator, under this proposed
rulemaking.
The Department's goal is to address potential compliance issues and
help resolve civil rights concerns at an early stage, avoiding the need
for an OCR investigation. The Department has also heard from a range of
stakeholders that it is important to include proactive measures to
increase covered entities' knowledge of their responsibilities under
Section 1557. The proposed complementary civil rights policies and
procedures advance these objectives.
This proposed requirement is also informed by OCR's enforcement
experience. It is common that, either during or following an
investigation, OCR will enter into a voluntary resolution agreement
with a covered entity that requires the adoption and implementation of
nondiscrimination policies as well as procedures for providing
auxiliary aids and services and reasonable modifications for
individuals with disabilities, and language assistance services for LEP
individuals.\271\ OCR's resolution agreements require these
interventions, in part, because our experience generally demonstrates
that targeting such interventions at the underlying
[[Page 47848]]
problems can result in covered entities being better positioned to
prevent discriminatory conduct in the future.
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\271\ See, e.g., Voluntary Resolution Agreement between U.S.
Dep't of Justice, U.S. Dep't Health & Human Servs., Office for Civil
Rights & William W. Backus Hosp. (2021), https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/agreements/vra-between-doj-hhs-ocr-william-backus-hospital/; Voluntary Resolution
Agreement between U.S. Dep't of Health & Human Servs., Office for
Civil Rights & CHRISTUS Trinity Mother Frances Health Sys. (2020),
https://www.hhs.gov/sites/default/files/christus-vra.pdf; Voluntary
Resolution Agreement between U.S. Dep't of Health & Human Servs.,
Office for Civil Rights & Mid-Maryland Musculoskeletal Inst. (2019),
https://www.hhs.gov/sites/default/files/MMI-vra.pdf; https://www.hhs.gov/sites/default/files/uconn-vra.pdf; Voluntary Resolution
Agreement between U.S. Dep't of Health & Human Servs., Office for
Civil Rights & Pa. Dep't of Human Servs. (2019), https://public3.pagefreezer.com/content/HHS.gov/31-12-2020T08:51/https://www.hhs.gov/sites/default/files/hhs-padhs-vra.pdf; Voluntary
Resolution Agreement between U.S. Dep't of Justice, U.S. Dep't
Health & Human Servs., Office for Civil Rights & Univ. of Vt. Med.
Ctr. (2017), https://www.hhs.gov/sites/default/files/uvmmc-vra.pdf;
Voluntary Resolution Agreement between U.S. Dep't of Health & Human
Servs., Office for Civil Rights & Erie Cty. Dep't of Soc. Servs.
(2016), https://www.hhs.gov/sites/default/files/ecdss-vra-final.pdf;
Voluntary Resolution Agreement between U.S. Dep't of Justice, U.S.
Dep't Health & Human Servs., Office for Civil Rights & St. Francis
Hosp. & Med. Ctr. (2015), https://www.hhs.gov/sites/default/files/stfrancishospital-vra.pdf.
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Through the implementation of Section 1557 Policies and Procedures,
a covered entity's employees will be better equipped to provide
services in a nondiscriminatory manner. For example, an employee will
be able to refer to the covered entity's official policy for providing
LEP individuals with language assistance services; such policies will
also be interpreted or translated as needed, and be available to an LEP
individual or their representative. Overall, the covered entity's
policies and procedures should bring consistency to the covered
entity's health programs and activities and improve compliance.
Finally, we note that many health care providers have adopted
policies and procedures required under OCR's existing civil rights
authorities and therefore would only need to review and update such
policies and procedures rather than creating them anew. For example,
this provision is consistent with OCR's civil rights clearance process
required of providers seeking initial certification or undergoing a
change of ownership to be certified as a Medicare Part A provider by
CMS.\272\ In order to obtain a civil rights clearance, would-be
Medicare Part A providers and businesses must have nondiscrimination
policies and procedures, including: policies and procedures to identify
and communicate orally and in writing with LEP individuals; policies
and procedures to ensure effective communication for individuals with
disabilities, including, where necessary, the provision of appropriate
auxiliary aids and services; and a description of how Medicare
providers and applicants make their program accessible to persons with
disabilities, among other things.\273\ This proposed provision would
establish similar obligations. Under this proposed provision, covered
entities may need to revise any pre-existing policies and procedures to
ensure they, at minimum, include the proposed required content.
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\272\ See Civil Rights Clearance for Medicare Provider
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/ (last updated Oct. 26, 2021).
\273\ See Technical Assistance for Medicare Providers and
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/technical-assistance/ (last updated
Oct. 27, 2021).
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The Department acknowledges that requiring covered entities to
develop and implement Section 1557 Policies and Procedures for their
health programs and activities would be a departure from previous
rulemakings, under which covered entities that implemented such
policies and procedures did so voluntarily. However, the Department's
enforcement and compliance assistance experience demonstrates that
interventions such as implementing policies and procedures can result
in covered entities being better positioned to prevent discriminatory
conduct and to better avoid the risk of an employee providing services
in a discriminatory manner. Thus, we are proposing the Section 1557
Policies and Procedures requirement because we believe that the lack of
such a requirement leaves individuals more susceptible to
discrimination and covered entities more susceptible to violations.
Specifically, as noted above, we believe that such a proactive measure
will more effectively increase covered entities' employees' knowledge
of their responsibilities under Section 1557. The Department
acknowledges that Section 1557 Policies and Procedures are not a
panacea for eliminating discrimination in health care; however, we
emphasize that our experience has indicated that implementing policies
and procedures that are the same or similar to the proposed Section
1557 Policies and Procedures helps prevent future instances of
discriminatory conduct.
Proposed paragraph (a) of this section requires covered entities to
implement written Section 1557 Policies and Procedures. The policies
and procedures must include an effective date and be reasonably
designed, taking into account the size, complexity, and the type of
health programs or activities undertaken by a covered entity, to ensure
compliance with this part.
Proposed paragraph (b) requires each covered entity to implement a
written nondiscrimination policy that, at minimum, provides the contact
information for the Section 1557 Coordinator (if applicable) and states
that the covered entity in its health programs and activities: does not
unlawfully discriminate on the basis of race, color, national origin
(including limited English proficiency and primary language), sex
(including pregnancy, sexual orientation, gender identity, and sex
characteristics), age, or disability; and provides language assistance
services and appropriate auxiliary aids and services free of charge,
when necessary for compliance with Section 1557 or this part.
Proposed paragraph (c) addresses the requirements for covered
entities with 15 or more employees with regard to grievance procedures
and recordkeeping in their health programs and activities, including
ensuring that the grievance procedure is accessible to LEP individuals
and individuals with disabilities.
In proposed paragraph (c)(1), OCR is proposing to require that
covered entities with more than 15 employees establish written civil
rights grievance procedures. This is similar to the 2016 Rule at former
Sec. 92.7, except that we propose to include a record retention
requirement. The 2020 Rule repealed former Sec. 92.7 and provided that
certain covered entities need only have a grievance procedure to the
extent the referenced statutes require it.\274\ We believe that the
requirement in proposed paragraph (c)(1) will restore consistency of
requirements for covered entities that existed under former Sec. 92.7.
It is also responsive to data related to improving health care visits
for historically marginalized communities, which indicate that a
majority of patients in these communities desire a method for
submitting grievances to health care providers so that the providers
can address the patients' problems.\275\ Though the referenced data did
not identify whether patients desired a mechanism to submit
discrimination grievances specifically, the data support the
supposition that, for patients of color, trust in their health care
providers would increase if these patients could voice their concerns
directly to their health care providers, thus, improving these
patients' overall health care experiences. Accordingly, the
Department's proposed Sec. 92.8(c) provides a mechanism for patients
to raise allegations of discrimination directly to their respective
health care providers. We expect covered entities to tailor the sample
grievance procedure to fit their different needs for flexibility,
efficiency, and cost effectiveness.
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\274\ 85 FR 37160, 37204 (Jun. 19, 2020) (``To the extent that
[the referenced statutes'] implementing regulations have . . .
grievance procedures, they are sufficient for enforcement of Section
1557.'').
\275\ Leslie Read et al., The Deloitte Ctr. for Health
Solutions, Rebuilding Trust in Health Care: What Do Consumers Want--
and Need--Organizations to Do?, p. 3 (2021) (``62% [of surveyed
people of color] want their local hospitals to ensure patients have
a voice to relay their experiences and take action to address their
problems.''), https://www2.deloitte.com/content/dam/insights/articles/US164518_CHS-Equity-trust/DI_Rebuilding-trust-in-healthcare.pdf.
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At paragraph (c)(2), we propose that a covered entity must retain
records related to grievances filed with it that allege discrimination
on the basis of race, color, national origin, sex, age, or disability
in its health programs and activities for no less than three (3) years
from the date of the filing of the
[[Page 47849]]
grievance. The records must include the grievance; the name and contact
information of the complainant (if provided by the complainant); the
alleged discriminatory action and alleged basis (or bases) of
discrimination; the date the grievance was filed; the grievance
resolution; and any other pertinent information. Pertinent information
includes, to the extent relevant to a particular complaint, information
related to the complainant's national origin (including limited English
proficiency and primary language), sex (including pregnancy, sexual
orientation, gender identity, or sex characteristics), etc.
Through its enforcement experience, OCR has found that obtaining
records of past grievances from covered entities is an important and
informative component of a thorough investigation, as it assists OCR in
identifying potential patterns or practices of discrimination that may
not otherwise be apparent while reviewing a single OCR discrimination
complaint. For example, if OCR receives a single discrimination
complaint from a person giving birth alleging discrimination on the
basis of race, OCR could review the grievances submitted to a covered
entity to identify the presence or absence of any potential patterns of
discrimination against people giving birth on the basis of race.
Without a requirement to retain grievances for a period of time, it is
more difficult for OCR to identify potential patterns or practices of
discrimination. This requirement will assist OCR not only in
identifying the scope of concern, but also in crafting appropriate
technical assistance and complaint resolutions.
OCR understands that retaining grievances for a specified period of
time is already the practice of some covered entities. This requirement
seeks to make the practice more consistent, thereby allowing OCR to
better identify potential patterns or practices of discrimination
during complaint investigations and compliance reviews. Having access
to discrimination complaints over a period of time will also allow
covered entities to be proactive in identifying potential patterns or
practices of discrimination, which will allow them to take corrective
actions, if necessary, before a complaint is filed with OCR. We believe
the three-year record retention requirement strikes the right balance
between covered entities' burden concerns and the need for access to
this vital information. However, while we propose to require records to
be kept for three (3) years, nothing in the proposed rule will prevent
covered entities from keeping their records for a longer period of time
if the recipient wishes or due to other legal obligations.\276\
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\276\ For example, the Department of Education Title IX
regulation requires recipients to keep records related to Title IX
sexual harassment grievances and investigations for a period of
seven (7) years. 34 CFR 106.45(b)(10).
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Proposed paragraph (c)(3) requires that a covered entity keep
confidential the identity of an individual who has filed a grievance,
except as required by law or to the extent necessary to carry out the
purposes of this proposed regulation, including the conduct of any
investigation.
We seek comment on the record retention requirement, particularly
with regard to patient privacy concerns or concerns regarding
potentially unauthorized use of information included in such records.
We seek comment on best practices for record retention of grievance
procedures, including strategies for ensuring patient privacy.
Rather than requiring health programs and activities of the
Department to adopt separate grievance procedures, the 2016 Rule
provided that, for the Department, the procedures for addressing
complaints of discrimination under Section 1557 would be deemed the
required grievance procedures under this section. We decline to
reinstate this approach, as individuals and the Department's health
programs and activities can also benefit from a process for covered
entities to address any potential compliance issues at an earlier stage
and in a less formal manner than an OCR investigation. However,
individuals may opt not to use a health program or activity's grievance
procedure and may elect to file a complaint with OCR at any time,
regardless of whether the health program or activity is conducted by a
recipient, the Department, or a Title I entity.
Proposed paragraph (d) requires covered entities to develop and
implement written language access procedures to support compliance with
requirements to take reasonable steps to provide meaningful access to
LEP individuals in their health programs and activities under proposed
Sec. 92.201. Given existing requirements to provide language
assistance to LEP individuals under Title VI and Section 1557, informed
by the Department's ``2003 Guidance to Federal Financial Assistance
Recipients Regarding Title VI Prohibition Against National Origin
Discrimination Affecting Limited English Proficient Persons'' (HHS LEP
Guidance),\277\ we anticipate that some covered entities may have
already implemented policies and procedures akin to this requirement.
Additionally, Federal agencies have been required to have language
access procedures since 2000, as provided for in E.O. 13166,\278\ and
the Department itself has a Language Access Plan.\279\ This requirement
is also consistent with the civil rights clearance process required for
Medicare Part A providers, which requires policies and procedures to
identify and communicate orally and in writing with LEP
individuals.\280\
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\277\ 68 FR 47311, 47316 (Aug. 8, 2003).
\278\ 65 FR 50121 (Aug. 16, 2000).
\279\ U.S. Dep't of Health & Human Servs., Language Access Plan
(2013), https://www.hhs.gov/sites/default/files/open/pres-actions/2013-hhs-language-access-plan.pdf.
\280\ Technical Assistance for Medicare Providers and
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/technical-assistance/ (last updated
Oct. 27, 2021).
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We propose that, at a minimum, a covered entity's language access
procedures must include information detailing the contact information
for the Section 1557 Coordinator (if applicable); how an employee
identifies whether an individual is LEP; how an employee obtains the
services of qualified interpreters and translators the covered entity
uses to communicate with LEP individuals; the names of any qualified
bilingual or multilingual staff members; and a list and the location of
any electronic and written translated materials the covered entity has,
the languages they are translated into, and the publication date. We
note that covered entities have a duty to translate that extends beyond
those documents that have already been translated at the time this list
is made, and the list should be updated periodically.
Proposed paragraph (e) requires covered entities to develop and
implement written effective communication procedures to support
compliance with requirements to take appropriate steps to ensure that
communications in their health programs and activities with individuals
with disabilities are as effective as communications with individuals
without disabilities under proposed Sec. 92.202. We propose that, at a
minimum, a covered entity's effective communication procedures must
include the contact information for the Section 1557 Coordinator (if
applicable); how an employee obtains the services of qualified
interpreters the covered entity uses to communicate with individuals
with disabilities; the names of any qualified interpreter staff
members; and how to access appropriate auxiliary aids and services that
are necessary for
[[Page 47850]]
effective communication. This provision is similarly consistent with
the civil rights clearance process required for Medicare Part A
providers, which requires policies and procedures to ensure effective
communication for individuals with disabilities, including, where
appropriate, the provision of auxiliary aids and services.\281\
---------------------------------------------------------------------------
\281\ Technical Assistance for Medicare Providers and
Applicants, U.S. Dep't of Health & Human Servs., Office for Civil
Rights, https://www.hhs.gov/civil-rights/for-providers/clearance-medicare-providers/technical-assistance/ (last updated
Oct. 27, 2021).
---------------------------------------------------------------------------
Proposed paragraph (f) requires covered entities to develop and
implement written procedures for making reasonable modifications to
their policies, practices, or procedures that allow individuals with
disabilities equal opportunity to participate in their health programs
and activities as required under proposed Sec. 92.205. As proposed, a
covered entity's reasonable modification procedures must, at a minimum,
include contact information for the covered entity's Section 1557
Coordinator (if applicable); describe the covered entity's process for
responding to requests from individuals with disabilities for changes,
exceptions, or adjustments to a rule, policy, practice, or service of
the covered entity; and the process for determining whether making the
modification would fundamentally alter the nature of the service,
program, or activity, including identifying an alternative modification
that does not result in a fundamental alteration to ensure the
individual with a disability receives the benefits or services in
question.
We note that the failure to request a reasonable modification does
not always excuse the covered entity from providing a reasonable
modification to avoid discrimination on the basis of disability, as
long as it does not result in a fundamental alteration. For example,
when a covered entity had knowledge of an individual's disability and
needs, or when an individual's disability and needs are obvious, a
covered entity must provide modifications in the absence of a
request.\282\
---------------------------------------------------------------------------
\282\ See, e.g., Greer v. Richardson Indep. Sch. Dist., 472 F.
App'x 287, 296 (5th Cir. 2012) (holding that a ``failure to
expressly `request' an accommodation is not fatal to an ADA claim
where the defendant otherwise had knowledge of the individual's
disability and needs but took no action''); Duvall v. Cty. of
Kitsap, 260 F.3d 1124, 1139 (9th Cir. 2001) (``When the plaintiff
has alerted the public entity to his need for accommodation (or
where the need for accommodation is obvious . . .), the public
entity is on notice that an accommodation is required . . .'').
---------------------------------------------------------------------------
Proposed paragraph (g) provides that a covered entity may combine
the content of the policies and procedures required by this provision
with any policies and procedures pursuant to other civil rights
statutory protections if they clearly comply with Section 1557 and the
provisions in this part.
The Department encourages covered entities to include additional
information in their Section 1557 Policies and Procedures to provide
employees the means to ensure individuals are able to access their
health programs and activities free from discrimination. For example,
covered entities may consider including information in their respective
Section 1557 Policies and Procedures regarding service animals, as well
as maintaining civil rights protections during public health
emergencies.
We seek comment on this proposed provision and whether there may be
alternative measures that the Department should consider to proactively
prevent discrimination, and whether they would be more or less
burdensome than what is proposed. We would particularly welcome
comments from covered entities concerning their experiences under
voluntary resolution agreements with OCR requiring them to adopt
policies and procedures. We also invite comment from all covered
entities that have previously implemented or are currently implementing
a nondiscrimination policy, grievance procedures, language access
procedures, effective communication procedures, or reasonable
modification procedures; consumers who interact with covered health
programs and activities; and community-based organizations that work
with LEP individuals and individuals with disabilities. We also seek
comment on whether covered entities employing less than 15 people
should be required to have a grievance procedure, including the
benefits for a less formal resolution process.
Training (Sec. 92.9)
To ensure that covered entities implement Section 1557 Policies and
Procedures in accordance with proposed Sec. 92.8, proposed Sec. 92.9
requires covered entities to train relevant employees in their health
programs and activities on their Section 1557 Policies and Procedures.
This proposed section, coupled with Sec. 92.8, is designed to help
covered entities and their employees take measures to prevent
discrimination by ensuring that staff are knowledgeable about the
nondiscrimination policy, grievance procedures, and processes by which
to obtain language assistance services for LEP individuals and to
ensure effective communication with and provide reasonable
modifications for individuals with disabilities.
Proposed paragraph (a) provides a general requirement that covered
entities train relevant employees of their health programs and
activities on the Section 1557 Policies and Procedures required by
proposed Sec. 92.8. Given the diversity of entities covered by this
part, the Department is not prescribing the specific training methods a
covered entity must use or the nature of a covered entity's training
program. The Department notes, however, that the more thoroughly a
covered entity trains its staff on its Section 1557 Policies and
Procedures, the more likely it is that the covered entity will
successfully provide services to individuals in a nondiscriminatory
manner and avoid potential liability for violations of Section 1557 and
this part.
Further, this provision takes into consideration potential burdens
on covered entities by requiring that only relevant staff (including,
but not limited to, the Section 1557 Coordinator, if applicable) be
trained, rather than requiring all staff to be trained. The Department
anticipates that relevant health program and activity staff will
include those involved in client and patient interactions, as well as
those involved with drafting, approving, and funding policies and
procedures for compliance with this part. However, such aspects of
training required by this section are left to the discretion of the
covered entity. The proposed approach, which requires training only on
the covered entity's Section 1557 Policies and Procedures, is
efficient, provides practical benefits based on each covered entity's
unique circumstances, and is less resource intensive than requiring
covered entities to train relevant staff on all of the regulatory
requirements for Section 1557's underlying statutes.
Similar to the proposal to require Section 1557 Policies and
Procedures, the Department believes in the importance of proactive
measures to prevent and mitigate the potential for discriminatory
conduct in covered health programs and activities. That is why the
Department proposes to require training in this rulemaking. OCR
provides public education and outreach and has found it to be an
effective means to ensure covered entities are complying with their
respective Federal civil rights obligations. Just as OCR's proactive
public education and outreach efforts yield compliance benefits, based
on the Department's enforcement and compliance assistance experience we
believe that covered entities' proactive Section 1557 Policies and
Procedures, coupled with employee training, will
[[Page 47851]]
yield compliance benefits as well as improved health outcomes.\283\
---------------------------------------------------------------------------
\283\ See, e.g., John S. Lord, Jr., Health Care Providers: It's
Not Just Employee Discrimination Claims--Patients Can Have
Discrimination Claims Too, Nat'l L. Rev. (Feb. 8, 2022)
(recommending ``perioding compliance reviews and up-to-date
trainings'' on civil rights nondiscrimination requirements to ``help
prevent and defend'' against patient discrimination claims), https://www.natlawreview.com/article/health-care-providers-it-s-not-just-employee-discrimination-claims-patients-can-have.
---------------------------------------------------------------------------
Federal agency technical assistance materials on language access
consistently highlight the important role training plays in delivering
services effectively. For example, CMS' ``Guide to Developing a
Language Access Plan'' dedicates an entire section to advising
organizations about the importance of training.\284\ The Guide
provides, in part, that an organization's training should focus on the
organizations' policies and procedures related to providing language
assistance services. Similarly, a DOJ assessment and planning tool for
federally conducted and federally assisted programs included ``training
staff on policies and procedures'' as one of the key six steps for
developing an effective language access policy.\285\ DOJ's tool
provides that ``[t]raining should explain how staff can identify the
language needs of an LEP individual, access and provide the necessary
language assistance services, work with interpreters, request document
translations, and track the use of language assistance services.''
\286\
---------------------------------------------------------------------------
\284\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare &
Medicaid Servs., Guide to Developing a Language Access Plan, p. 9,
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Language-Access-Plan-508.pdf.
\285\ U.S. Dep't of Justice, Language Access Assessment and
Planning Tool for Federally Conducted and Federally Assisted
Programs, p. 6 (2011), https://www.lep.gov/sites/lep/files/resources/2011_Language_Access_Assessment_and_Planning_Tool.pdf.
\286\ Id.
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The Department believes that a staff training requirement will
increase the likelihood that covered entities are prepared to best meet
the communication needs of LEP individuals and individuals with
disabilities, avoiding potentially critical delays or denials of care.
This is particularly salient as the nation addresses the COVID-19
pandemic and works to prepare for future public health emergencies. As
described above, the COVID-19 pandemic exposed barriers to accessing
health care for historically marginalized populations, including
challenges related to providing testing and vaccination services in a
way that provides meaningful access to LEP individuals and is
accessible to individuals with disabilities. For example, many covered
entities required individuals to register on a website or through an
online portal in order to obtain a COVID-19 test or vaccine. Websites
and portals often failed to include non-English registration
instructions,\287\ and some have been inaccessible to individuals with
disabilities.\288\
---------------------------------------------------------------------------
\287\ Joseph R. Fuchs et al., Older Adults with Limited English
Proficiency Need Equitable COVID-19 Vaccine Access, 69 J. Am.
Geriatr. Soc'y. 888, 889 (2021), https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.17069; Rachana
Pradham, `Press 1 for English': Vaccination Sign-Ups Prove Daunting
for Speakers of Other Languages, Kaiser Health News (Mar. 23, 2021),
https://khn.org/news/article/press-1-for-english-vaccination-sign-ups-prove-daunting-for-speakers-of-other-languages/.
\288\ Press release, U.S. Dep't of Justice, Justice Department
Secures Settlement with Rite Aid Corporation to Make Its Online
Covid-19 Vaccine Portal Accessible to Individuals with Disabilities
(Nov. 1, 2021), https://www.justice.gov/usao-mdpa/pr/justice-department-secures-settlement-rite-aid-corporation-make-its-online-covid-19; Press release, U.S. Dep't of Justice, Justice Department
Secures Agreement with Hy-Vee Supermarket Chain to Make Online
COVID-19 Vaccine Registration Accessible for People with
Disabilities (Dec. 1, 2021), https://www.justice.gov/opa/pr/justice-department-secures-agreement-hy-vee-supermarket-chain-make-online-covid-19-vaccine; Lauren Weber & Hannah Recht, Covid Vaccine
websites Violate Disability Laws, Create Inequity for the Blind,
Kaiser Health News (Feb. 25, 2021), https://khn.org/news/article/covid-vaccine-websites-violate-disability-laws-create-inequity-for-the-blind/; Haley Messenger, Blind Americans Face Roadblocks Booking
Online Vaccine Appointments, NBC News (Mar. 13, 2021, 6:02 a.m.),
https://www.nbcnews.com/business/consumer/blind-americans-face-roadblocks-booking-online-vaccine-appointments-n1260954; Fixing the
Problem of Inaccessible Information from the Beginning, Equidox,
https://equidox.co/blog/fixing-the-problem-of-inaccessible-covid-19-information/ (last visited June 15, 2022); Elise Young, Vaccine
Rollout Leaves Behind the Blind, Paralyzed, Autistic, Bloomberg
(Mar. 18, 2021, 10:25 a.m.), https://www.bloomberg.com/news/articles/2021-03-18/disabled-citizens-left-behind-in-u-s-push-to-overcome-pandemic; Maggie Vaughn, Vaccine Registration websites:
Inaccessible to the Blind, Dubbot: DubBlog (Mar. 10, 2021), https://dubbot.com/dubblog/2021/vaccine-registration-websites-inaccessibile-to-the-blind.html.
---------------------------------------------------------------------------
We have previously noted that, when necessary, OCR enters into
voluntary resolution agreements with covered entities to resolve
concerns about noncompliance with Federal civil rights laws, including
Section 1557.\289\ These voluntary resolution agreements routinely
require covered entities to develop policies and procedures and provide
employee training on their policies and procedures because such actions
promote compliance with Federal civil rights laws. OCR believes that
the development and implementation of, and training on, such policies
are likely to reduce discriminatory actions from occurring in the
future and reduce the need for voluntary resolution agreements.
---------------------------------------------------------------------------
\289\ See Recent Civil Rights Resolution Agreements & Compliance
Reviews, U.S. Dep't of Health & Human Servs., Office for Civil
Rights, https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/agreements/ (last updated June 15, 2022); see
also supra note 271.
---------------------------------------------------------------------------
Proposed paragraph (a) provides a general requirement that covered
entities train relevant employees of their health programs and
activities on the civil rights policies and procedures required by
proposed Sec. 92.8.
Proposed paragraph (b) specifies when covered entities must train
relevant employees on their Section 1557 Policies and Procedures. We
consider relevant employees to be those who directly encounter or
interact with individuals such as patients, clients, and members of the
public. Employees are also considered relevant when they make decisions
regarding the services individuals seek from a covered entity's health
programs and activities. Under paragraph (b)(1) covered entities would
be required to train existing relevant employees on their Section 1557
Policies and Procedures as soon as practicable, but no later than one
(1) year after the effective date of the Final Rule. Proposed paragraph
(b)(2) proposes that covered entities train new relevant employees
within a reasonable period of time after they join a covered entity's
workforce.
In paragraph (b)(3), we propose to require covered entities to
train relevant employees whose roles are affected by material changes
to the covered entity's Section 1557 Policies and Procedures. Examples
of material changes may include new contact information for a covered
entity's Section 1557 Coordinator (if applicable), changing from one
qualified interpreter service provider to another, acquiring or
discontinuing the use of certain auxiliary aids and services, such as
in response to changing technology, or substantive changes to the
covered entity's process for ensuring effective communication or for
providing language assistance services. Similar to paragraph (b)(2),
paragraph (b)(3) would require covered entities to train employees
within a reasonable time after a material change has been made. Nothing
in the proposed provision prohibits covered entities from training
their employees on Section 1557 Policies and Procedures more
frequently. For example, covered entities may include such training in
the existing annual or quarterly training programs that they require
their employees to complete.
Proposed paragraph (c) requires covered entities to
contemporaneously document their employees' completion of the training
required by this section
[[Page 47852]]
in written or electronic form and maintain said documentation for no
less than three (3) calendar years.
We note that neither the 2016 Rule nor the 2020 Rule included a
training requirement, though we are aware that many covered entities
already have civil rights trainings for their employees that could be
modified to comply with this proposed provision. We seek comment on the
experiences of covered entities in implementing training such as that
required by proposed Sec. 92.9, examples of where training made a
difference in compliance, the timing of required training, whether
covered entities would like the flexibility to include this required
training as part of its existing annual compliance training, what types
of changes would constitute a material change such that a covered
entity would need to retrain staff, and the amount of time for which
training records must be retained. We also seek general comment on this
proposal, including the effectiveness of civil rights training
programs, the benefits experienced by covered entity staff and the
people they serve, as well as the costs associated with the proposed
training requirements.
We further seek comment on whether the Section 1557 Policies and
Procedures requirements and training requirements may increase the
likelihood of compliance with the substantive legal requirements of
Section 1557.
Notice of Nondiscrimination (Sec. 92.10)
Proposed Sec. 92.10 requires each covered entity to provide a
notice of nondiscrimination, relating to its health programs and
activities, to participants, beneficiaries, enrollees, and applicants
of its health programs and activities, and members of the public.
Notice can be provided through written translations or in-language
recorded audio or video clips.
The 2016 Rule required covered entities to include a
nondiscrimination notice and set of taglines (i.e., a short non-English
statement in appropriate languages indicating the availability of
language assistance services) in all ``significant publications or
significant communications . . . which may include patient handbooks,
outreach publications, or written notices pertaining to rights or
benefits or requiring a response from an individual'' in conspicuous
physical locations and online.\290\ The 2016 Rule included a separate
provision for ``small-sized'' significant publications
communications.\291\ This provision required covered entities to
include a notice statement in lieu of the full notice, on small-sized
significant publications and significant communications like postcards
and tri-fold brochures.\292\
---------------------------------------------------------------------------
\290\ 81 FR 31375, 31396 (May 18, 2016).
\291\ Former 45 CFR 92.8(g)(1).
\292\ Id.
---------------------------------------------------------------------------
The 2016 Rule received criticism for failing to provide a
definition of ``significant publications or significant
communications,'' though it provided some examples of what would be
considered ``significant.'' The Department also received substantial
feedback regarding the financial burden imposed by the notice and
tagline requirements. Citing these concerns, the 2020 Rule repealed the
2016 Rule's provisions on notices and taglines in their entirety.\293\
---------------------------------------------------------------------------
\293\ 85 FR 37160, 37161, 37176, 37228 (June 19, 2020).
---------------------------------------------------------------------------
The Department has reviewed concerns raised in response to the 2016
Rule requirements, as well as those raised in response to the removal
of the notice and tagline requirements in the 2020 Rule. Although we
acknowledge the additional responsibilities placed on covered entities
through the 2016 Rule requirements, we believe that the 2020 Rule does
not adequately consider some of the adverse consequences that
individuals incur or the burdens that the health care system faces
without these notice provisions.\294\ Therefore, the Department has
concluded that it should not have eliminated these provisions in their
entirety. To ensure clarity and reduce confusion, this proposed rule
will address the notice of nondiscrimination and notice of availability
of language assistance services and auxiliary aids and services in
separate sections.
---------------------------------------------------------------------------
\294\ See, e.g., Nat'l Council of Asian Pacific Ams., Comment on
Section 1557 NPRM, pp. 3-7 (Aug. 13, 2019), https://www.regulations.gov/comment/HHS-OCR-2019-0007-145953.
---------------------------------------------------------------------------
Proposed Sec. 92.10(a) requires covered entities to provide a
notice of nondiscrimination, relating to their health programs and
activities, to participants, beneficiaries, enrollees, and applicants
of their health programs and activities, and to members of the public.
Proposed paragraph (a)(1) provides the required contents of the notice
of nondiscrimination, including that (i) the covered entity does not
discriminate on the basis of race, color, national origin (including
limited English proficiency and primary language), sex (including
pregnancy, sexual orientation, gender identity, or sex
characteristics), age, or disability in its health programs or
activities; (ii) the covered entity provides reasonable modifications
for individuals with disabilities, and appropriate auxiliary aids and
services, including qualified interpreters, for individuals with
disabilities and information in alternate formats, such as braille or
large print, free of charge and in a timely manner, when such
modifications or aids and services are necessary to ensure
accessibility and equal opportunity to participate to individuals with
disabilities; (iii) the covered entity provides language assistance
services, including electronic and written translated documents and
oral interpretation free of charge and in a timely manner, when such
services are necessary to provide meaningful access to a limited
English proficient individual; (iv) how to obtain from the covered
entity the reasonable modifications, auxiliary aids and services, and
language assistance services in paragraphs (a)(1)(ii) and (iii) of this
section; (v) the contact information for the covered entity's Section
1557 Coordinator designated pursuant to Sec. 92.7 of this part (if
applicable); (vi) the availability of the covered entity's grievance
procedure pursuant to Sec. 92.8(c) of this part and how to file a
grievance (if applicable); (vii) details on how to file a
discrimination complaint with HHS' Office for Civil Rights; and (viii)
how to access the covered entity's website, if it has one, that
provides the information required under paragraph (a)(1) of this
section. OCR is proposing to require a parenthetical for national
origin discrimination, to include limited English proficiency and
primary language, to clarify for the public that these are prohibited
forms of discrimination. For the same reason, a parenthetical would be
required for sex discrimination, to include pregnancy, sexual
orientation, gender identity, or sex characteristics.
Proposed Sec. 92.10(a)(2) would provide specific information on
when and where covered entities must provide the notice of
nondiscrimination. Rather than requiring entities to include the notice
in ``significant'' communications, we propose that covered entities
provide the notice on an annual basis and upon request. Similar to the
2016 Rule requirements, we propose that the notice also be placed at a
conspicuous location on the covered entity's health program or activity
website,\295\ if it has
[[Page 47853]]
one, and in clear and prominent physical locations where it is
reasonable to expect individuals seeking service from the health
program or activity to be able to read or hear the notice. These
requirements would pose a relatively low-cost burden for covered
entities while ensuring information regarding the covered entity's
civil rights obligations is provided in locations that are highly
visible and visited by participants and members of the public.
---------------------------------------------------------------------------
\295\ For more information about improving access to public
websites for LEP individuals, see U.S. Dep't of Justice, Title VI
Interagency Working Group, Improving Access to Public websites and
Digital Services for Limited English Proficient (LEP) Persons (Dec.
2021), https://www.lep.gov/sites/lep/files/media/document/2021-12/2021_12_07_website_Language_Access_Guide_508.pdf.
---------------------------------------------------------------------------
Paragraph (b) proposes that a covered entity may combine the
content of the notice required by paragraph (a) of this section with
the notices required by Title VI, Section 504, Title IX, and the Age
Act implementing regulations \296\ if the combined notice clearly
informs individuals of their civil rights under Section 1557 and this
part and meets the requirements outlined in proposed paragraph (a)(1).
---------------------------------------------------------------------------
\296\ 45 CFR 80.6(d) (Title VI); Sec. 84.8 (Section 504,
federally assisted); Sec. 85.12 (federally conducted); Sec. 86.9
(Title IX); Sec. 91.32 (Age Act).
---------------------------------------------------------------------------
In drafting these proposed notice provisions, the Department
considered alternative approaches such as requiring covered entities to
provide notices at every encounter with a participant or beneficiary or
simply adopting the approach in the 2016 Rule. The Department decided
against these approaches, and believes the proposed provisions
emphasize the importance of notifying individuals of their civil rights
and makes clear the requirements for notifying individuals about
important civil rights requirements. Further, we believe this proposal
addresses the burdens raised by covered entities in response to the
2016 Rule notice requirements by providing specific occurrences (annual
basis and upon request) and locations (conspicuous location on website
and prominent physical location) for when and where the notice must be
provided rather than the ambiguity caused by the 2016 Rule.
We seek comment on whether the notice of nondiscrimination
requirement as proposed is practical, likely to be effective, and
responsive to concerns raised regarding the 2016 and 2020 Rules,
including the sufficiency of the content of the notice and requirements
regarding when and where covered entities must provide the notice. In
particular, we seek comment on the best ways to provide an accessible
initial notice to individuals who may require auxiliary aids and
services for their disabilities and the best way in which to provide
the notice in a manner accessible to LEP individuals. The Department is
also interested in hearing from covered entities regarding whether they
are still following the 2016 notice requirement, and the potential
burdens and costs of what is proposed here.
Notice of Availability of Language Assistance Services and Auxiliary
Aids and Services (Sec. 92.11)
Proposed Sec. 92.11 requires covered entities to notify the public
of the availability of language assistance services and auxiliary aids
and services for their health programs and activities (``Notice of
Availability''). This provision is similar to the ``tagline''
requirement found at former Sec. 92.8 in the 2016 Rule, but with
additional information required to be included in the notice. The 2016
Rule required covered entities to provide ``taglines,'' short
statements written in non-English languages that indicate the
availability of language assistance services free of charge, in a
variety of languages and communications.\297\ The Department has opted
not to use the term ``tagline'' in this rule because this provision
also now requires a notice of the availability of auxiliary aids and
services.
---------------------------------------------------------------------------
\297\ Former 45 CFR 92.8.
---------------------------------------------------------------------------
The 2016 Rule required covered entities to include ``taglines'' in
at least the top 15 languages spoken by LEP individuals in the relevant
state or states in significant publications and communications and at
various locations.\298\ To reduce the administrative burden on covered
entities, OCR translated these statements into 64 languages and made
the translated statements available to covered entities.\299\
---------------------------------------------------------------------------
\298\ Id. Sec. 92.8(d)(1).
\299\ 81 FR 31453.
---------------------------------------------------------------------------
The 2020 Rule repealed this provision, citing costs, confusion, and
waste, but stated that covered entities are still required ``to provide
taglines whenever such taglines are necessary to ensure meaningful
access by LEP individuals to a covered program or activity.'' \300\
Commenters argued the 2019 NPRM's Regulatory Impact Analysis (RIA)
labeled the impact on LEP individuals of eliminating notice and tagline
requirements as negligible without providing an evidentiary basis \301\
and failed to address the costs beneficiaries would face without these
provisions and the additional costs to the health care system that
could result.\302\ We now believe that in finalizing the 2020 Rule
absent any ``tagline'' requirement, the Department did not adequately
weigh the concerns raised by commenters, including the costs
individuals incur or the burdens the health care system would face
without these requirements.\303\
---------------------------------------------------------------------------
\300\ See 85 FR 37160, 37176, 37228, 37241 (June 19, 2020).
\301\ See id. at 37204.
\302\ See Nat'l Council of Asian Pacific Ams., supra note 294,
at pp. 3-7; see also 85 FR 37233.
\303\ See supra note 302.
---------------------------------------------------------------------------
Commenters specifically argued that eliminating ``tagline''
provisions would result in fewer safeguards that minimize health care
risks LEP individuals face in the health care system, including
avoidable hospital readmissions, lower rates of outpatient follow up,
limited use of preventive services, poor medication adherence, and lack
of understanding discharge instructions.\304\ According to commenters,
these impacts could lead to higher costs to the health care system, as
LEP individuals are more likely to experience medical errors due to
communication barriers. The availability of language assistance
services, on the other hand, is associated with fewer readmission rates
and fewer malpractice claims.\305\
---------------------------------------------------------------------------
\304\ See Nat'l Women's Law Ctr., Comment on Section 1557 NPRM,
p. 21 (Aug. 13, 2019), https://www.regulations.gov/comment/HHS-OCR-2019-0007-149018.
\305\ See Nat'l P'ship for Women & Families, Comment on Section
1557 NPRM, p. 16 (Aug. 13, 2019) (citing to Quan K. Lynch, Nat'l
Health Law Program, The High Costs of Language Barriers in Medical
Malpractice, p. 18 (2010)), https://www.regulations.gov/comment/HHS-OCR-2019-0007-137897.
---------------------------------------------------------------------------
Several organizations have sued the Department for repealing the
notice and tagline provisions of the 2016 Rule. The lawsuits detail the
costs of repealing these requirements. In the Whitman-Walker case, the
plaintiffs, organizations providing and advocating for health care
services, and individual health care professionals, alleged that the
removed provisions are critical to ensuring meaningful access to
care.\306\ The plaintiffs further argued that removing the 2016 Rule's
tagline provisions, ``burden[s] private health care and individual
provider plaintiffs, as well as members of health professional
association plaintiffs, because patients will come to them sicker due
to inadequate care elsewhere, and more people may come to them because
their LEP services will remain robust.'' \307\ The plaintiffs also
alleged that eliminating the notice provisions would make it more
difficult for patients ``to understand their health care rights,
communicate with doctors and other health care workers, and navigate
complex insurance and medical
[[Page 47854]]
documents with specialized terminology, and cause an increase in
patients who will delay or not seek care at all.'' \308\ In Chinatown
Services Center v. U.S. Department of Health & Human Services, the
plaintiffs, community-based organizations that serve older LEP adults,
similarly alleged that elimination of the notice and tagline
requirements of the 2016 Rule undermines access to health care, and
that the elimination was arbitrary and capricious because HHS did not
consider alternatives to repealing these protections.\309\ The
Chinatown Service Center plaintiffs alleged the 2020 Rule fails to
adequately consider the confusion caused by the removal of taglines,
the impact of the rule change on access to care and treatment,
individuals' reliance on taglines, and frustration with difficulty
accessing health care.\310\ The complaint alleges that ``without notice
of their rights, LEP older adults remain in the dark as to their right
to free interpreter services at a medical appointment or what they can
do when providers wrongly require LEP individuals to rely on
unqualified informal or family-member interpreters.'' \311\
---------------------------------------------------------------------------
\306\ Whitman-Walker Compl., supra note 205, at p. 67-68.
\307\ Id. at p. 68.
\308\ Id. at p. 28.
\309\ Compl., Chinatown Serv. Ctr. v. U.S. Dep't of Health &
Human Servs., No. 1:21-cv-00331, pp. 23, 35 (D.D.C. Feb. 5, 2021),
ECF No. 1 [hereinafter Chinatown Serv. Ctr. Compl.].
\310\ Id. at p. 21.
\311\ Id. at p. 2.
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The Department has also heard from covered entities that they are
committed to providing LEP individuals with language assistance
services but recommend that the Department require covered entities to
provide language assistance services in a manner that does not
overwhelm enrollees with redundant paperwork that may be unnecessary,
repetitive, or wasteful.\312\
---------------------------------------------------------------------------
\312\ AHIP Recommendations for 1557 Notice and Tagline
Requirements, p. 1 (Nov. 1, 2021). The document will be attached to
the docket of this proposed rule as a supplemental material at
federalregister.gov.
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After considering concerns raised through litigation, stakeholder
feedback, and language access complaints OCR continues to receive, we
have determined that the 2020 Rule's approach in eliminating these
provisions in their entirety is unnecessary and counterproductive. We
believe that the benefits of meaningful access to LEP individuals,
through notice of the availability of language access services,
outweigh the costs of implementing the changes set forth in this NPRM.
The 2020 Rule creates uncertainty and confusion concerning when
language assistance services must be provided, resulting in higher risk
for covered entities while rendering Section 1557 less effective at
combatting discrimination experienced by LEP individuals. The
Department believes that the provisions set forth in this NPRM would
help restore consistency in language assistance procedural requirements
and provide certainty to covered entities and consumers about what
covered entities' obligations are and what rights consumers have.
The proposed reinstatement of in-language notices is also intended
to help alleviate burdens on covered entities who primarily serve LEP
populations. LEP individuals often rely on community-based
organizations as the first line of support when they are unable to
access other systems due to language barriers. While we recognize that
this reported increase coincides with the COVID-19 pandemic, we also
believe it highlights the importance now, more than ever, of providing
notice of the availability of language assistance services in health
programs and activities. Additionally, we believe having these services
in place now will help covered entities be better prepared to serve LEP
individuals during any future public health emergencies that may arise.
In addition, several commenters to the 2019 NPRM indicated that
removing the 2016 Rule's tagline provisions would contribute to health
disparities. For example, the National Women's Law Center referenced a
2018 poll, which said approximately 6 in 10 Latino adults reported
having trouble communicating with their providers due to language or
cultural barriers.\313\ As a result, the poll reported that Spanish-
speaking LEP individuals are more likely to report experiencing worse
health outcomes than Latino individuals who are monolingual in English
or bilingual in English and Spanish.\314\ Although the 2020 Rule
removed the requirement that covered entities include ``taglines'' in
the top 15 languages spoken by LEP individuals in their state, it
maintained the requirement that covered entities provide taglines
whenever such taglines are necessary to ensure meaningful access by LEP
individuals to a covered health program or activity. Yet the 2020 Rule
provides limited guidance to covered entities and consumers on what
covered entities' obligations are and what consumers' rights are.
Covered entities remain without clear guidance as to when in-language
taglines must be included to help LEP individuals understand that
language services are available and how to access them. OCR continues
to receive language access complaints that raise concerns about
entities not providing sufficient taglines. The proposed ``Notice of
Availability'' requirement, analogous to the 2016 Rule ``tagline''
requirement, removes existing ambiguity for covered entities and would
result in increased access to health programs and activities for LEP
individuals.
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\313\ Nat'l Women's Law Ctr., supra note 304, at p. 21.
\314\ Id.
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While the 2020 Rule preamble raised concerns about cost and waste,
we believe it failed to strike the right balance by eliminating these
important provisions altogether given the considerations discussed
above. With proposed Sec. 92.11, we seek to be responsive to industry
concerns regarding excessive costs and other potential burdens to
covered entities, while balancing the importance of providing LEP
individuals notice of the availability of language assistance services
to eliminate barriers to accessing quality health care. In this new
provision, we also propose to require the Notice of Availability to
include a statement regarding the availability of appropriate auxiliary
aids and services to reduce barriers to access for individuals with
disabilities.
Proposed paragraph (a) requires a covered entity to provide a
notice that, at minimum, states that the covered entity provides
language assistance services and appropriate auxiliary aids and
services free of charge in its health programs and activities, when
necessary for compliance with Section 1557 or this part. This notice
must be provided to participants, beneficiaries, enrollees, and
applicants of the covered entity's health program or activity, and
members of the public. Notice can be provided through written
translations or recorded audio or video clips.
Proposed paragraph (b) requires the Notice of Availability to be
provided in English and at least the 15 most common languages spoken by
LEP individuals of the relevant state or states, and in alternate
formats for individuals with disabilities who request auxiliary aids
and services to ensure effective communications. This standard ensures
that a significant proportion of each state's particular LEP population
is receiving key information in the appropriate language. While the
standard of providing the statement in these ``top 15'' languages is
the same as that required by the 2016 Rule, we attempt to alleviate
burdens here by proposing a list of the relevant materials in which the
Notice of Availability must be included and providing options for
covered entities to allow individuals to ``opt out'' of receipt of the
Notice of
[[Page 47855]]
Availability or to provide communication to individuals in their
primary language in lieu of a Notice of Availability. As in 2016, OCR
will provide a sample Notice of Availability for covered entities to
use, as well as the 15 most common non-English languages spoken by LEP
individuals for each state and territory.
The Department considered including a population threshold after
consulting the Department of Agriculture's Supplemental Food and
Nutrition regulation, which includes requirements prescribed by the
Food Stamp Act \315\ to translate materials in non-English
languages.\316\ The Department declines to include the adoption of a
population threshold because of the inconsistent results that would
result in notice requirements for urban and rural communities.\317\ The
Department also considered requiring translation of the Notice of
Availability in the ``top 15'' languages to the extent that there are
at least 200 LEP speakers for a particular language in the relevant
state or states. This standard would require fewer language
translations for states such as Montana (notices in only 11 languages)
and Wyoming (notices in only 4 languages). However, we declined to
institute this alternative so as to not include an arbitrary cut-off,
such as 200 LEP speakers, into the proposed regulation, and instead
provided covered entities alternatives to the requirement to provide a
Notice of Availability. We seek comment on this approach.
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\315\ 7 U.S.C. 2020(e)(1)(B).
\316\ 7 CFR 272.4(b)(2); see also 65 FR 70143-44 (Nov. 21, 2000)
(discussing access to households with language access barriers).
\317\ See 43 FR 47846, 47849 (Oct. 17, 1978) (``Although many
commenters suggested adoption of a uniform percentage test, the
Department rejected that concept because it could require bilingual
service in sparsely populated areas where only two or three
households are of a single language minority. Conversely, in densely
populated low-income areas, hundreds of single-language areas and
hundreds of single-language minority households could be an
insufficient number to meet the percentage test required for
bilingual services.'').
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Proposed Sec. 92.11(c) requires the notice be provided on an
annual basis to participants, beneficiaries, enrollees (including late
and special enrollees), and applicants, and upon request at any time.
Similar to the notice of nondiscrimination requirement in proposed
Sec. 92.10, the Notice of Availability would also be required to be
provided at a conspicuous location on the covered entity's health
program or activity website, if it has one, and in clear and prominent
physical locations where it is reasonable to expect individuals seeking
service from the health program or activity to be able to read or hear
the notice. This notice must also be accessible to individuals with
disabilities who require auxiliary aids and services. These
requirements would pose a relatively low-cost burden for covered
entities and ensure information about language assistance services is
provided in locations that are highly visible and visited by members of
the public.
In response to concerns raised by stakeholders regarding the lack
of specificity in the term ``significant publications or significant
communications,'' rather than providing a general class of documents
for which the notice must be provided (e.g., ``significant
documents''), we propose in paragraph (c)(5) to provide a list of
specific electronic and written communications that must be accompanied
by the Notice of Availability. After consideration, we believe this
approach is more tailored to the needs of LEP individuals and
individuals with disabilities when accessing important information
regarding a range of health programs and activities and provides the
level of specificity sought by covered entities.
We propose to require the Notice of Availability to accompany the
following documents: (i) the notice of nondiscrimination required by
proposed Sec. 92.10 of this part; (ii) the notice of privacy practices
required by the implementing regulations for the Health Insurance
Portability and Accountability Act of 1996 \318\ (HIPAA) at 45 CFR
164.520; (iii) application and intake forms; (iv) notices of denial or
termination of eligibility, benefits, or services, including
Explanations of Benefits (EOBs), and notices of appeal and grievance
rights; (v) communications related to a person's rights, eligibility,
benefits, or services that require or request a response from a
participant, beneficiary, enrollee, or applicant; (vi) communications
related to a public health emergency; (vii) consent forms and
instructions related to medical procedures or operations, medical power
of attorney, or living will (with an option of providing only one
notice for all documents bundled together); (viii) discharge papers;
(ix) complaint forms; and (x) patient and member handbooks.
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\318\ Public Law 104-191, 100 Stat. 2548 (1996).
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We considered limiting the requirement to include the notice of
availability of language assistance services and auxiliary aids in EOBs
to only those EOBs that notify individuals of a cost-sharing
responsibility. In other words, an EOB showing that services have been
fully covered and that the patient has no further financial
responsibility for the service (including co-payment, co-insurance,
disallowed cost for which a provider may bill the patient, or other
charge) would not constitute a notice of a denial or termination of
benefits or services, and therefore would not be required to include
the notice of availability. However, we determined that the burden of
administering a process to assess which EOBs fall under the requirement
and then include the notice only to those EOBs would be more burdensome
than the alternative of including the notice in all EOBs. We invite
comment as to whether this is the most appropriate approach, balancing
the burden of providing notices of availability with all EOBs against
the burdens associated with determining which EOBs must include the
notice.
To further alleviate the potential burdens of subsection (d), we
propose alternative, optional methods by which a covered entity may be
deemed in compliance with proposed Sec. 92.11(a). First, pursuant to
proposed paragraph (d)(1), a covered entity shall be deemed in
compliance with respect to an individual if the covered entity, on an
annual basis: provides individuals, in their primary language and
through any appropriate auxiliary aids and services, the option to opt
out of receipt of the Notice of Availability; does not condition
receipt of any aid or service on the decision to opt out; informs the
individual of their right to receive the notice upon request in their
primary language and through any appropriate auxiliary aids and
services, and that opting out of receiving the notice is not a waiver
of their right to receive language assistance services and any
appropriate auxiliary aids and services as required by this part in
their primary language and through any appropriate auxiliary aid or
service; documents, on an annual basis, the individual's decision to
opt out; and does not treat a non-response from an individual as a
decision to opt out. Second, proposed paragraph (d)(2) provides that a
covered entity shall be deemed in compliance with this section with
respect to an individual if the covered entity documents the
individual's primary language and any appropriate auxiliary aids and
services and either provides all materials and communications in that
individual's primary language and through any appropriate auxiliary
aids and services, or provides the notice required by Sec. 92.11(a) in
that individual's primary language and through any appropriate
auxiliary aids
[[Page 47856]]
and services in all communications that are identified in Sec.
92.11(c)(5).
In drafting these proposed provisions, the Department considered
alternative approaches, such as requiring covered entities to provide
the Notice of Availability at every interaction with a participant or
beneficiary, or simply adopting the approach in the 2016 Rule. However,
the unnecessary duplication of requiring covered entities to provide a
Notice of Availability at every interaction with a beneficiary
outweighs any potential benefit, and simply adopting the approach in
the 2016 Rule would not address confusion regarding covered entities'
legal obligations related to the term ``significant documents'' or
concerns expressed about financial burden. We also considered an opt-in
approach whereby covered entities would offer individuals an
opportunity to opt in to receiving a copy of a covered entity's Notice
of Availability. However, given the varying nature of Section 1557
covered entities, it would be difficult to specify when covered
entities must offer individuals the opportunity to opt in to receiving
its Notice of Availability. More importantly, we believe that the
information contained in the proposed Notice of Availability is
indispensable to the receipt of services free from discrimination.
Accordingly, by providing an opt-out option, proposed Sec. 92.11
attempts to balance the potential financial burden on covered entities
of providing the Notice of Availability against the essential need for
individuals to understand their rights and therefore would limit the
burden without jeopardizing individual access to information.
The Department believes the approach in this proposed rule
emphasizes the importance of notifying individuals of their civil
rights and makes clear the requirements for notifying individuals about
important civil rights requirements. The Department also believes the
proposed rule addresses concerns raised by covered entities in response
to the 2016 Rule requirements.
We seek comment on whether the Notice of Availability requirement
as proposed is practical and responsive to concerns raised regarding
the 2016 and 2020 Rules, including the sufficiency of the content of
the Notice of Availability and requirements on when and where covered
entities must provide the notice. We also seek comment as to whether it
adequately addresses the specific concerns raised regarding the burdens
associated with the 2016 Rule requirements by providing a list of
specific documents with which the Notice of Availability must be
provided. Additionally, we seek comment on how to best provide the
Notice of Availability to individuals with disabilities to ensure they
know how to request and receive relevant materials and documents in
formats that meet their disability-related needs, and whether covered
entities should be required to provide the Notice of Availability in
sign language. Similarly, we seek comment on how to best provide the
Notice of Availability to LEP individuals, including LEP individuals
with disabilities, to ensure they know how to request and receive
language assistance services and auxiliary aids and services to provide
meaningful access to relevant materials and documents. We also seek
comment on whether the list of communications proposed adequately
captures the documents for which LEP individuals and individuals with
disabilities should receive the Notice of Availability. We further seek
comment on the anticipated costs to covered entities of various sizes
to comply with the proposed requirements.
Data Collection
Commenters on the 2015 NPRM requested that OCR require covered
entities to collect additional data, beyond those required by the
referenced statutes and their regulations, on race, ethnicity,
language, sex, gender, gender identity, sexual orientation, disability,
and age, in part so that such entities could better plan how to meet
the needs of those populations.\319\ We considered including a
provision in the rule requiring covered entities to collect additional
civil rights data given the vital role data can play in ensuring civil
rights compliance and the fact that such data remain largely
uncollected for many demographic subgroups. At this time, however, we
are not including such a provision but are soliciting feedback and
comments on such data collection to inform a final rule and OCR's
overall civil rights work.
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\319\ 81 FR 31375, 31392-93 (May 18, 2016).
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The COVID-19 pandemic serves as an example of the importance of
access to data collection in addressing harm at the earliest possible
stages of a public health emergency in order to provide effective and
lifesaving health care. In the early days of the COVID-19 pandemic,
public health officials lacked the data necessary to gain a full
picture of how the pandemic was impacting marginalized communities,
prompting the publication of tools like the COVID Racial Data Tracker.
The COVID Racial Data Tracker was created out of a collaboration
between the COVID Tracking Project and the Boston University Center for
Antiracist Research to gather racial and ethnic demographic data to
understand the outbreak of COVID-19 and protect vulnerable
communities.\320\ Indeed, as the COVID-19 pandemic has highlighted, the
lack of demographic data can make it challenging to determine where
public health disparities are occurring and where to allocate resources
such as COVID-19 testing and vaccinations.\321\ These issues have civil
rights implications. Just as nearly all of the provisions in this
proposed rule benefit Section 1557 covered entities as much as they
benefit the public, a data collection provision has the potential to
benefit state and local health departments because they would be able
to use the data they collect to reveal existing health disparities and
proactively allocate and disseminate the resources necessary to address
public health disparities.
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\320\ About the Racial Data Tracker, covidtracking.com, https://covidtracking.com/race/about (last visited June 15, 2022).
\321\ See Tom Simonite, Covid Hits Minorities Hardest, But Data
Often Doesn't Show It, Wired Business (Aug. 24, 2020, 7:00 a.m.),
https://www.wired.com/story/covid-hits-minorities-hardest-data-doesnt-show/; Laura Barron-Lopez et al., Missing Data Veils
Coronavirus Damage to Minority Communities, Politico (June 14, 2020,
7:00 a.m.), https://www.politico.com/news/2020/06/14/missing-data-veils-coronavirus-damage-to-minority-communities-316198.
---------------------------------------------------------------------------
Since the beginning of the COVID-19 pandemic, the Federal
Government has responded with several data collection resources--which
can be used by Federal, State, territorial, and local governments
alike--to provide a clearer picture of how COVID-19 is impacting
communities across the country. Executive Order 13985, ``Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government,'' established the Interagency Working Group on
Equitable Data with the goal of collecting more disaggregated data
across Federal agencies to be better equipped to measure and advance
equity through the work of every Federal agency.\322\ Data that the
Federal Government has recently made available can continue to be used
to reveal and address long-existing health disparities. Some examples
of health data the Federal Government is collecting include those in
HHS' Protect Public Data Hub,\323\ which is a secure data ecosystem for
sharing, parsing, housing, and accessing COVID-19 data; CDC data
[[Page 47857]]
on COVID-19 cases and deaths by state or territory; \324\ those in the
HealthData.gov COVID-19 Reported Patient Impact and Hospital Capacity
by State Timeseries, which provides state-aggregated data for hospital
utilization in a timeseries format; \325\ and those in the
HealthData.gov COVID-19 Diagnostic Laboratory Testing Time Series,
which reports COVID-19 test results from over 1,000 U.S. laboratories
and testing locations, including commercial and reference laboratories,
public health laboratories, and other testing locations.\326\ This is
not an exhaustive list of the Federal Government's data collection
activities, but merely identifies some examples of what has changed
since the beginning of the COVID-19 pandemic.
---------------------------------------------------------------------------
\322\ 86 FR 7009 (Jan. 25, 2021).
\323\ HHS Protect Public Data Hub, https://protect-public.hhs.gov/ (last June 15, 2022).
\324\ United States COVID-19 Cases and Deaths by State over
Time, data.cdc.gov, https://data.cdc.gov/Case-Surveillance/United-States-COVID-19-Cases-and-Deaths-by-State-o/9mfq-cb36 (last updated
June 15, 2022).
\325\ COVID-19 Reported Patient Impact and Hospital Capacity by
State Timeseries, HealthData.gov, https://healthdata.gov/Hospital/COVID-19-Reported-Patient-Impact-and-Hospital-Capa/g62h-syeh (last
updated June 15, 2022).
\326\ COVID-19 Diagnostic Laboratory Testing (PCR Testing) Time
Series, HealthData.gov, https://healthdata.gov/dataset/COVID-19-Diagnostic-Laboratory-Testing-PCR-Testing/j8mb-icvb (last updated
June 15, 2022).
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When considering adding a data collection provision to this
proposed rule, the Department contemplated what kind of additional data
we might require covered entities to collect and from which covered
entities the Department should collect such data. In addition to race,
ethnicity, language, age, and disability, we considered requiring
covered entities to collect data on sex, gender, gender identity, and
sexual orientation from patients and health care providers. Some states
and territories, including California and Washington, DC, currently
require plans sold on their Health Insurance Exchanges to collect
demographic data about enrollees' race and ethnicity, but not sexual
orientation or gender identity.\327\ In Colorado, a new state law will
require issuers to offer a standardized ``Colorado Option'' plan on the
State Exchange in 2023, which includes a requirement to offer a
culturally responsive network of providers.\328\ Additionally, the
state's law requires issuers to attempt to collect demographic data,
including race, ethnicity, disability status, sex, sexual orientation,
and gender identity from their providers and the providers' front
office staff.\329\ The Department understands there may be concerns
related to requiring covered entities to collect deeply personal data.
On one hand, the access to such data can provide a clearer picture of
disparities and gaps in patient outcomes and representation in the
provision of care. On the other hand, some providers and patients are
hesitant to provide data on their race, sexual orientation, or gender
identity for fear of discrimination.\330\ The Department recognizes the
challenges associated with requiring covered entities to collect such
data.
---------------------------------------------------------------------------
\327\ Markian Hawryluk, Some Physicians Are Uneasy as Colorado
Collects Providers' Diversity Data, npr.org (April 25, 2022, 5:00
a.m.), https://www.npr.org/sections/health-shots/2022/04/25/1094354537/colorado-doctor-diversity-data.
\328\ Id.
\329\ Id.
\330\ Id.
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The Department believes that rather than codifying a specific set
of data collection measures within this rulemaking, the Department--
through OCR--is better positioned to create a dynamic and responsive
civil rights data collection structure by using its existing
authorities. OCR does have the authority to request compliance data
from covered entities under its existing civil rights authorities,
which we propose to codify for purposes of Section 1557 at proposed
Sec. 92.303(a) (incorporating by reference 45 CFR 80.6 with regard to
recipients and State Exchanges) and proposed Sec. 92.303(c) (with
regard to the Department and Federally-facilitated Exchanges). Using
our existing authorities would be similar to the Department of
Education (ED)'s civil rights data collection process. Since 1968, ED's
Office for Civil Rights has, without a regulatory standard for a
recurring civil rights data collection, required its elementary and
secondary education recipients to collect data \331\ on the leading
civil rights data indicators related to access and barriers to an
educational opportunity from early childhood through 12th grade,
disaggregated by race/ethnicity, sex, disability, and English Learner
status.\332\ By using existing authorities, the Department believes OCR
will have the flexibility to be responsive to the critical health-
related civil rights issues that may arise in the future.
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\331\ ED's current authority to collect data comes from section
203(c)(1) of the Department of Education Organization Act (20 U.S.C.
3413(c)(1)) and is informed by the regulations implementing several
of the civil rights statutes that it implements authorizing
collection of data that are necessary to ensure compliance with
civil rights laws within the jurisdiction of ED's OCR.
\332\ 20 U.S.C. 3413(c)(1). See also 34 CFR 100.6(b), Sec.
104.61, Sec. 106.71; Civil Rights Data Collection: Frequently Asked
Questions, U.S. Dep't of Educ., Office for Civil Rights, https://www2.ed.gov/about/offices/list/ocr/frontpage/faq/crdc.html (last
modified Apr. 14, 2021).
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We seek comment on this general approach, including whether covered
entities are already collecting disaggregated demographic data in their
health programs and activities and, if so, for which categories of
data, through what systems, and at what cost. We also seek comment on
how a civil rights data collection requirement could impact current
data collection efforts, either positively or negatively. We also seek
comment on whether the adoption of a regulatory standard for a
recurring civil rights data collection would benefit civil rights
enforcement, as well as how frequently the data should be submitted to
OCR. We also seek comment on whether the data collection requirements
should vary by type of entity, as recipients of Federal financial
assistance include a variety of entities, including state and local
agencies, health insurance issuers, health care providers, health care
facilities and clinics, hospitals, federally qualified health centers,
and health-related educational and training programs. Accordingly, we
seek comment on which types of recipients (if any) should be covered;
if recipients under a certain size should be exempt from the data
collection requirement, and if so, should that be based on employee
number, the number of beds (if relevant), or some other metric; what
types of data should be collected; what definitions should be used; the
potential costs associated with such a requirement; and the potential
benefits of such a requirement.
Subpart B--Nondiscrimination Provisions
For the reasons described below, Subpart B of the proposed rule
generally adopts certain regulatory provisions regarding specific
discriminatory actions prohibited by the implementing civil rights
statutes referenced in Section 1557(a): Title VI, Section 504, Title
IX, and the Age Act.
Discrimination Prohibited (Sec. 92.101)
Proposed Sec. 92.101(a) provides a general prohibition of
discrimination on the basis of race, color, national origin, sex, age,
or disability under any health program or activity to which Section
1557 or this part applies and provides additional detail regarding what
constitutes discrimination on the basis of sex. Proposed paragraph (b)
identifies some specific forms of prohibited discrimination.
Proposed paragraph (a)(1) provides the general prohibitions on
discrimination under Section 1557 by restating the core objective of
Section 1557: ensuring that covered entities do not discriminate on the
basis of race, color, national origin, sex, age, or disability against
any individual seeking
[[Page 47858]]
to participate in or receive the benefits of the covered entity's
health program or activity. Consistent with Federal case law \333\ and
existing Federal civil rights enforcement,\334\ the Department's
proposed nondiscrimination protections prohibit discrimination based
upon a person's actual or perceived race, color, national origin, sex,
age, or disability.
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\333\ See Fogleman v. Mercy Hosp., 283 F.3d 561, 572 (3d Cir.
2002) (employee of hospital employer may pursue retaliation claim
even if employer's perception that employee was Muslim is factually
incorrect); EEOC v. WC&M Enters., 496 F.3d 393, 400-01 (5th Cir.
2007) (national origin harassment of an Indian Muslim employee
included harassment based on the employer's perception that he was
an Arab Muslim); Glenn v. Brumby, 663 F.3d 1312, 1319 (11th Cir.
2011) (``An individual cannot be punished because of his or her
perceived gender-nonconformity.'') (emphasis added); Jones v. UPS
Ground Freight, 683 F.3d 1283 (11th Cir. 2012) (employer may still
be liable for harasser's use of epithets associated with an ethnic
or racial minority different than that of the plaintiff employee);
Estate of Lance v. Lewisville Indep. Sch. Dist., 743 F.3d 982, 991
(5th Cir. 2014) (``. . . [section] 504's reach extends not only to
individuals who in fact have a disability, but also to individuals
who are regarded as having a disability (whether or not that
perception is correct)''); but cf. El v. Max Daetwyler Corp., 451 F.
App'x 257 (4th Cir. 2011) (per curiam opinion affirmed district
court's order granting employer's motion to dismiss because Title
VII does not ``contain an explicit provision for the protection of
persons who are merely perceived to be a part of a protected
class'').
\334\ See U.S. Equal Emp't Opportunity Comm'n, EEOC Enforcement
Guidance on National Origin Discrimination, n.16 (Nov. 18, 2016),
https://www.eeoc.gov/laws/guidance/national-origin-guidance.cfm#ftn16 (Title VII prohibits employer actions that have
the purpose or effect of discriminating against persons because of
their real or perceived race, national origin, or association with a
particular religion) (emphasis added); Housing Discrimination and
Persons Identified as Lesbian, Gay, Bisexual, Transgender, and/or
Queer/Questioning (LGBTQ), U.S. Dep't of Hous. & Urban Dev., https://www.hud.gov/program_offices/fair_housing_equal_opp/housing_discrimination_and_persons_identifying_lgbtq (last updated
Feb. 1, 2022) (``Persons who identify as LGBTQ and believe they have
experienced housing discrimination because of their actual or
perceived sexual orientation or gender identity can assert their
rights under the Fair Housing Act by filing a complaint with HUD.'')
(emphasis added); Race and National Origin Discrimination Frequently
Asked Questions, U.S. Dep't of Educ., https://www2.ed.gov/about/offices/list/ocr/frontpage/faq/race-origin.html (last modified Jan.
1, 2020) (``Discrimination on the basis of race, color, national
origin includes discrimination based on a person's actual or
perceived race, color, national origin, ethnicity, or ancestry.'')
(emphasis added).
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Proposed paragraph (a)(2) clarifies that discrimination on the
basis of sex includes discrimination on the basis of sex stereotypes;
sex characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; and gender identity.
The proposed inclusion of ``sex stereotypes'' codifies the Supreme
Court's holding in Price Waterhouse v. Hopkins that discrimination on
the basis of sex stereotypes is a form of sex discrimination.\335\ As
the Court there explained, ``we are beyond the day when an employer
could evaluate employees by assuming or insisting that they matched the
stereotype associated with their group,'' for ``[i]n forbidding
employers to discriminate against individuals because of their sex,
Congress intended to strike at the entire spectrum of disparate
treatment of men and women resulting from sex stereotypes.'' \336\ The
Supreme Court reiterated this principle in Bostock, explaining that
``an employer who fires both [a woman] and [a man] for failing to
fulfill traditional sex stereotypes doubles rather than eliminates
Title VII liability.'' \337\
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\335\ 490 U.S. 228, 250-51 (1989).
\336\ Id.; cf. U.S. v. Virginia, 518 U.S. 515, 533 (1996) (in
making classifications based on sex, states ``must not rely on
overboard generalizations about the different talents, capacities,
or preferences of males and females'').
\337\ Bostock v. Clayton Cty., 140 S. Ct. 1731, 1742-43 (2020).
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We are proposing to include ``sex characteristics'' because
discrimination based on anatomical or physiological sex characteristics
(such as genitals, gonads, chromosomes, hormone function, and brain
development/anatomy) is inherently sex-based. Discrimination on the
basis of intersex traits is similarly prohibited sex discrimination
because the individual is being discriminated against based on their
sex characteristics. If their sex characteristics were different--i.e.,
traditionally ``male'' or ``female''--the intersex person would be
treated differently. Moreover, like gender identity and sexual
orientation, intersex traits are ``inextricably bound up with''
sex,\338\ and ``cannot be stated without referencing sex.'' \339\ The
DOJ has similarly concluded that Bostock's reasoning applies to
discrimination based upon intersex traits.\340\
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\338\ Id. at 1742.
\339\ Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d 586, 608 (4th
Cir. 2020) (quoting Whitaker v. Kenosha Unified Sch. Dist. No. 1 Bd.
of Educ., 858 F.3d 1034, 1051 (7th Cir. 2017)).
\340\ See Memorandum from Kristen Clarke, Assistant Att'y Gen.,
Civil Rights Div., U.S. Dep't of Justice, to Dep't of Justice Office
of Justice Programs, Office of Cmty. Oriented Policing Servs.,
Office on Violence Against Women, & Money Laundering & Asset
Recovery Section, 2 (Mar. 10, 2022), https://www.justice.gov/crt/page/file/1481776/download; U.S. Dep't of Justice, Title IX Legal
Manual, Title IX Cover Addendum post-Bostock (updated Aug. 12,
2021), https://www.justice.gov/crt/title-ix#Bostock.
---------------------------------------------------------------------------
The proposed inclusion of ``pregnancy or related conditions'' is
consistent with the longstanding interpretation of sex discrimination
under Title IX, including the Department's Title IX implementing
regulation.\341\
---------------------------------------------------------------------------
\341\ See Conley v. Northwest Fla. State Coll., 145 F. Supp. 3d
1073 (N.D. Fla. 2015). See also 45 CFR 86.21(c)(2), (3); Sec.
86.40(b)(1), (4), (5); Sec. 86.51(b)(6); Sec. 86.57(b)(d) (Title
IX regulation).
---------------------------------------------------------------------------
The proposed inclusion of ``sexual orientation'' and ``gender
identity'' is consistent with the Supreme Court's reasoning in Bostock.
As explained in the Department's Bostock Notification, the Court's
reasoning applies to Title IX and, by extension, to Section 1557.\342\
Given the similarity in nondiscrimination language between Title VII
and Title IX, most Federal courts \343\ that have addressed the issue,
and the Departments of Justice and Education, have interpreted Title IX
consistent with Bostock's reasoning.\344\
---------------------------------------------------------------------------
\342\ 86 FR 27984 (May 25, 2021).
\343\ Doe v. Snyder, No. 21-15668, 2022 WL 711420, at *9 (9th
Cir. Mar. 10, 2022); Grimm v. Gloucester Cty. Sch. Bd., 972 F.3d at
616; Koenke v. Saint Joseph's Univ., No. 19-cv-4731, 2021 WL 75778,
at *2 (E.D. Pa. Jan. 8, 2021); Doe v. Univ. of Scranton, No. 3:19-
cv-01486, 2020 WL 5993766, at *11 n.61 (M.D. Pa. Oct. 9, 2020); but
see Neese v. Becerra, No. 2:21-cv-00163-Z, 2022 WL 1265925, at *14
(N.D. Tex. Apr. 26, 2022) (denying motion to dismiss, finding ``at
this stage of litigation, the approved tools of textualism do not
support'' application of Bostock to ``Title IX--and by extension
Section 1557'').
\344\ Karlan Memo, supra note 46; 86 FR 32637 (June 22, 2021)
(Department of Education).
---------------------------------------------------------------------------
The Franciscan Alliance court concluded that the 2016 Rule's
definition of ``sex'' as including ``gender identity'' was contrary to
Section 1557 because ``Title IX and Congress' incorporation of it in
[Section 1557 of] the ACA unambiguously adopted the binary definition
of sex.'' \345\ The Department disagrees. In Bostock, the Supreme Court
held that the prohibition on discrimination ``because of . . . sex''
under Title VII covers discrimination on the basis of gender identity
and sexual orientation even assuming that ``sex'' refers ``only to
biological distinctions between male and female.'' \346\ Title IX and
Section 1557 prohibit discrimination ``on the basis of sex.'' \347\
Because their statutory prohibitions against sex discrimination are
similar, the Supreme Court and other Federal courts consistently look
to interpretations of Title VII to inform Title IX.\348\ Thus,
Bostock's discussion of the text of Title VII informs the Department's
analysis of Title IX and Section 1557.
---------------------------------------------------------------------------
\345\ Franciscan All., Inc. v. Burwell, 227 F. Supp. 3d 660, 689
(N.D. Tex. 2016).
\346\ 140 S. Ct. at 1744.
\347\ 20 U.S.C. 1681(a); 42 U.S.C. 18116.
\348\ See, e.g., Franklin v. Gwinnett Cty. Pub. Sch., 503 U.S.
60, 75 (1992); Jennings v. Univ. of N.C., 482 F.3d 686, 695 (4th
Cir. 2007); Gossett v. Oklahoma ex rel. Bd. of Regents for Langston
Univ., 245 F.3d 1172, 1176 (10th Cir. 2001).
---------------------------------------------------------------------------
First, like Title VII, Title IX and Section 1557 apply to sex
discrimination against an individual. Title VII states that it is
unlawful for an
[[Page 47859]]
employer ``to fail or refuse to hire or to discharge any individual, or
otherwise to discriminate against any individual'' regarding their
``compensation, terms, conditions, or privileges of employment, because
of such individual's race, color, religion, sex, or national origin.''
\349\ The Bostock Court focused on this feature of Title VII in
reaching its holding.\350\ Similarly, Title IX states that ``no person
in the United States shall, on the basis of sex, be excluded from
participation in, be denied the benefits of, or be subjected to
discrimination under any education program or activity receiving
Federal financial assistance.'' \351\ Furthermore, Section 1557
provides that ``an individual shall not, on the ground prohibited
[under Title VI, Title IX, the Age Act, or Section 504] be excluded
from participation in, be denied the benefits of, or be subjected to
discrimination under, any health program or activity, any part of which
is receiving Federal financial assistance.'' \352\
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\349\ 42 U.S.C. 2000e-2(a)(1) (emphasis added).
\350\ Bostock, 140 S. Ct. at 1740-41 (``[The statute] tells us
three times--including immediately after the words ``discriminate
against''--that our focus should be on individuals.'').
\351\ 20 U.S.C. 1681(a) (emphasis added).
\352\ 42 U.S.C. 18116 (emphasis added).
---------------------------------------------------------------------------
Second, Title IX's ``on the basis of'' sex language is sufficiently
similar to ``because of'' sex under Title VII as to be considered
interchangeable. In Bostock itself, the Supreme Court described Title
VII's language that way: ``[I]n Title VII, Congress outlawed
discrimination in the workplace on the basis of race, color, religion,
sex, or national origin.'' \353\ The Bostock Court concluded that Title
VII's prohibition of discrimination ``because of'' sex includes
discrimination because of sexual orientation and transgender status,
finding that when an employer discriminates against employees for being
gay or transgender, ``the employer must intentionally discriminate
against individual men and women in part because of sex.'' \354\
Indeed, the Court clearly held that it is ``impossible to discriminate
against a person'' for being gay or transgender ``without
discriminating against that individual on the basis of sex.'' \355\
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\353\ Bostock, 140 S. Ct. at 1737; see also Meritor Sav. Bank,
FSB v. Vinson, 477 U.S. 57, 64 (1986) (``[W]hen a supervisor
sexually harasses a subordinate because of the subordinate's sex,
that supervisor `discriminate[s]' on the basis of sex.'') (emphasis
added).
\354\ Bostock, 140 S. Ct. at 1740-43.
\355\ Id. at 1741.
---------------------------------------------------------------------------
The same reasoning in Bostock supports the interpretation that
Title IX's prohibition of discrimination ``on the basis of'' sex, and,
relatedly, that Section 1557's prohibition on discrimination ``on the
ground prohibited under Title IX'' prohibits covered entities from
discriminating against an individual based on that person's sexual
orientation or transgender status. After considering the text of Title
IX and Section 1557, Supreme Court case law, and developing
jurisprudence in this area, the Department has determined that the best
reading of Title IX's prohibition on discrimination ``on the basis of
sex'' and Section 1557's prohibition on discrimination ``on the ground
prohibited under Title IX'' is that it includes discrimination on the
basis of gender identity and sexual orientation. Should there be any
ambiguity read into the statutory text of Title IX or Section 1557 with
regard to this issue, the Department would nonetheless adopt this
interpretation given the statutory objectives of the civil rights
statutes and the importance of ensuring that individuals are able to
receive health care free from discrimination.
Proposed paragraph (b) identifies several specific forms of
prohibited discrimination under Section 1557. It does so by
incorporating by reference the specific prohibitions on discrimination
in the regulations implementing each civil rights statute referenced in
Section 1557's statutory text. Even though Section 1557 provides an
independent basis for the regulation of discrimination in covered
programs and activities, this proposed section expressly adopts the
specific prohibitions on discrimination found in the implementing
regulations of the referenced antidiscrimination statutes. We believe
this approach is appropriate in light of Section 1557's express
adoption of the same language used in the four referenced statutes to
describe the nature of the prohibited conduct--namely, causing an
individual to ``be excluded from participation in, be denied the
benefits of, or be subjected to discrimination under'' a specified
program or activity. Incorporating by reference the regulations that
have long described certain forms of such conduct under those specified
statutes is consistent with the ACA and provides clarity, while not
including redundant text in this rule. The text proposes to direct the
reader to the ``prohibitions on discrimination'' in sections of the
Title VI, Section 504, Title IX (subparts C and D), and Age Act
(subpart B) regulations. This is similar to the approach taken in the
2016 Rule but, rather than citing specific provisions, we propose a
general reference.
Though the 2020 Rule purported to clarify covered entities' Section
1557 obligations, it sought to do so through general statements. The
2020 Rule, at Sec. 92.2, generally provides the nondiscrimination
requirements of Section 1557 by restating the statutory language of 42
U.S.C. 18116(a), followed by stating that the grounds prohibited are
the grounds found in the Title VI, Title IX, Section 504, and Age Act
statutes. This approach has caused confusion by eliminating guidance as
to certain specific discriminatory actions that one generally finds in
an implementing regulation for a civil rights statute. The Department
believes it is helpful for covered entities and protected individuals
to have additional clarity regarding some common, specific prohibitions
under Section 1557.
We believe the proposed approach is the most reasonable reading of
Section 1557's direction that ``an individual shall not . . . be
excluded from participation in, be denied the benefits of, or be
subjected to discrimination under, any health program or activity, any
part of which is receiving Federal financial assistance, including
credits, subsidies, or contracts of insurance, or under any program or
activity that is administered by an Executive Agency or any entity
established under this title (or amendments).'' \356\ Because this
language is adapted from the four referenced statutes, it is reasonable
and appropriate to look to those statutes' implementing regulations to
further clarify what it means to discriminate on the grounds prohibited
by those statutes. Rather than restating each of the specific
prohibitions on discrimination under each implementing regulation, we
propose that Sec. 92.101(b) simply cross-reference the implementing
regulations of these referenced civil rights statutes. Note that this
proposed rule does not in any way limit or impact the interpretation of
those statutes.
---------------------------------------------------------------------------
\356\ 42 U.S.C. 18116(a).
---------------------------------------------------------------------------
Proposed paragraph (b)(1)(i) specifically refers to recipients of
Federal financial assistance and State Exchanges; proposed paragraph
(b)(1)(ii) refers to the Department's health programs and activities,
including Federally-facilitated Exchanges. Under both of these
paragraphs, covered entities would be prohibited from the
discriminatory actions found in the applicable sections of the Title
VI, Title IX, and Age Act implementing regulations, found at 45 CFR
parts 80, 86 (subparts C and D), and 91 (subpart B), respectively. For
the specific discriminatory actions provided for in Section 504
implementing regulation, recipients and State Exchanges will look
[[Page 47860]]
to the implementing regulation at 45 CFR part 84 (federally funded),
and the Department will look to the implementing regulation at 45 CFR
part 85 (federally conducted).
Proposed paragraph (b)(2) provides that the enumeration of specific
forms of discrimination in paragraph (b) of this section does not limit
the general application of the prohibition in proposed paragraph (a) of
this section. Although some of these provisions would articulate
specific forms of prohibited discrimination that have not otherwise
been articulated under some of the underlying statutes referenced in
Section 1557, these provisions are included to ensure parity across all
prohibited bases of discrimination under Section 1557 with regard to
covered entities' health programs and activities.
The 2016 Rule included, at former Sec. 92.101(b)(3)(ii) and (iii),
provisions specifically related to prohibited discrimination on the
basis of sex related to criteria and methods of administration and
selection of facility sites and locations that have the effect of
discriminating on the basis of sex or the purpose or effect of
defeating or substantially impairing the accomplishment of the
objectives of the program or activity on the basis of sex. The 2020
Rule removed these paragraphs. The 2016 Rule language is similar to
language found in the implementing regulations for Title VI, Section
504, and the Age Act.\357\ The Department has determined not to include
a similar provision here as the Department believes it is important to
preserve--and not expand--the longstanding treatment of disparate
impact in the referenced statutes' implementing regulations. We seek
comment on this approach, including whether a provision similar to that
included in the 2016 Rule is necessary, and whether it should be
limited to discrimination on the basis of sex, or should also include
each of the enumerated grounds covered under Section 1557's statutory
prohibition on discrimination.
---------------------------------------------------------------------------
\357\ 45 CFR 80.3(b)(2), (3) (Title VI); Sec. 84.4(b)(4), (5)
(Section 504); Sec. 90.12.(b) (Age Act).
---------------------------------------------------------------------------
Subpart C--Specific Applications to Health Programs and Activities
Because of Section 1557's unique application to health programs and
activities, Subpart C provides additional specificity regarding
nondiscrimination requirements in this setting. The provisions in this
subpart are responsive to the nature and importance of health care,
health insurance, and related decision-making as it impacts individuals
and communities protected by Section 1557's prohibition of
discrimination. These provisions are intended to provide clear
instruction to covered entities and are informed by OCR's stakeholder
outreach and experience in both enforcement and in providing technical
assistance.
Meaningful Access for Limited English Proficient Individuals (Sec.
92.201)
Proposed Sec. 92.201 effectuates Section 1557's prohibition on
national origin discrimination as it is applied to LEP individuals in
covered health programs and activities. For LEP individuals, the lack
of proficiency in English and the use of non-English languages is often
tied to their national origin. It is well-established that an entity
may violate Title VI and its implementing regulation by failing to take
reasonable steps to provide meaningful access to LEP individuals.\358\
The provision of free and effective language assistance services to LEP
individuals is essential to ensure compliance with nondiscrimination
laws.
---------------------------------------------------------------------------
\358\ See, e.g., Lau v. Nichols, 414 U.S. 563, 566 (1974)
(interpreting Title VI and its implementing regulations to require a
school district with students of Chinese origin with limited English
proficiency to take affirmative steps to provide the students with a
meaningful opportunity to participate in federally funded
educational programs); Dep't of Health, Educ., & Welfare,
Identification of Discrimination and Denial of Services on the Basis
of National Origin, 35 FR 11595 (July 18, 1970); E.O. 13166,
Improving Access to Services. for Persons with Limited English
Proficiency, 65 FR 50121 (Aug. 16, 2000) (directing Federal agencies
that extend assistance subject to the requirements of Title VI to
publish guidance for their respective recipients clarifying the
obligation to provide language services to LEP individuals); Dep't
of Justice, Guidance to Federal Financial Assistance Recipients
Regarding Title VI Prohibition Against National Origin
Discrimination Affecting Limited English Proficient Persons, 67 FR
41455, 41457 (June 18, 2002); Dep't of Educ., Office for Civil
Rights & Dep't of Justice, Civil Rights Div., Dear Colleague Letter:
English Learner Students and Limited English Proficient Parents
(Jan. 7, 2015), https://www2.ed.gov/about/offices/list/ocr/letters/colleague-el-201501.pdf.
---------------------------------------------------------------------------
Proposed paragraph (a) provides that covered entities ``must take
reasonable steps to provide meaningful access to each limited English
proficient individual eligible to be served or likely to be directly
affected by its health programs and activities.'' This language is
nearly identical to the 2016 Rule at former Sec. 92.201(a), which
required a covered entity to take reasonable steps to provide
meaningful access to each LEP individual ``eligible to be served or
likely to be encountered.'' \359\ The Department is proposing to revise
this language slightly to include individuals likely to be ``directly
affected'' rather than ``encountered.'' This language is consistent
with the 2003 HHS LEP Guidance \360\ and OCR resolution
agreements,\361\ and we believe this language provides more clarity for
covered entities regarding the individuals for whom reasonable steps
must be taken. As the Department has advised in the past, ordinarily,
persons eligible to be served or likely to be directly affected by a
recipient's program are those persons who are in the covered entity's
service area, and who either are eligible for the covered entity's
benefits or services, or otherwise might be directly affected by such
an entity's conduct. For example, a parent seeking health services for
a child would be seen as directly affected by a covered entity's
policies and practices.\362\
---------------------------------------------------------------------------
\359\ Former 45 CFR 92.201(a).
\360\ 68 FR 47311, 47314 (Aug. 8, 2003).
\361\ See, e.g., Voluntary Resolution Agreement between U.S.
Dep't Health & Human Servs., Office for Civil Rights & Pa. Dep't of
Human Servs. (2019), https://www.hhs.gov/sites/default/files/hhs-padhs-vra.pdf.
\362\ See, e.g., 65 FR 52762, 51767-68 (Aug. 30, 2000).
---------------------------------------------------------------------------
The language of the 2020 Rule differs from the 2016 Rule in that it
requires reasonable steps to ensure meaningful access ``to programs or
activities by limited English proficient individuals,'' rather than
``each'' LEP individual.\363\ The preamble to the 2020 Rule explains
this change by arguing that the 2016 Rule's ``stringent requirement . .
. could potentially be interpreted to require a covered entity to
provide language assistance services to every LEP individual it comes
into contact with.'' \364\ The plain language of the 2016 Rule in fact
required that covered entities must take reasonable steps to provide
meaningful access to each individual with limited English proficiency
eligible to be served or likely to be encountered in its health
programs and activities.\365\ For example, a surgeon would likely
determine that it is a reasonable step to provide an interpreter when
discussing the risks and aftercare of a particular procedure with an
LEP individual in order to afford that individual meaningful access;
however, a hospital may determine that reasonable access can be
provided via sight translation of a generic brochure for an LEP patient
rather than providing a fully translated version. This standard does
not impose a significant burden on covered entities, as it does not
mandate that every LEP individual receive language services,
[[Page 47861]]
but rather that covered entities at a minimum conduct a reasonable
steps evaluation for each LEP individual. However, the Department notes
that, as the availability of telephonic interpreters increases, the
evaluation of the reasonableness of providing language services shifts.
---------------------------------------------------------------------------
\363\ 85 FR 37160, 37245 (June 19, 2020); 45 CFR 92.101(a).
\364\ 85 FR 37210.
\365\ 81 FR 31375, 31470 (May 18, 2016).
---------------------------------------------------------------------------
Taking reasonable steps to assess and meet the needs of each LEP
individual eligible to be served or likely to be directly affected by
the covered entity's health program or activity is important to ensure
compliance with both Title VI and Section 1557. The need for a case-by-
case determination is particularly important in the area of health
care. As noted in the preamble to the 2016 Rule,
[S]afe and quality health care requires an exchange of
information between the health care provider and patient for the
purposes of diagnoses, treatment options, the proper use of
medications, obtaining informed consent, and insurance coverage of
health-related services, among other purposes. This exchange of
information is jeopardized when the provider and the patient speak
different languages and may result in adverse health consequences
and even death. Indeed, the provision of health care services, by
its `very nature[,] requires the establishment of a close
relationship with the client or patient that is based on sympathy,
confidence and mutual trust,' which cannot be established without
effective communication.\366\
---------------------------------------------------------------------------
\366\ Id. at 31413.
Ensuring accurate, timely, and high-quality communication within
the health care context is particularly important to LEP individuals
and their families, who can be put in danger by not understanding a
physician or other health care provider and the health protocols those
individuals may prescribe. For example, an LEP parent or guardian may
leave a doctor's office misunderstanding how to properly care for their
child, putting the well-being of the child at risk due to
miscommunication between the parent or guardian and the doctor
regarding the health details of the child. Vigorous communication
standards are extremely important in helping to minimize the health
care risks LEP people face in the health care system, including lower
rates of outpatient follow up, poor medication adherence, and a lack of
understanding of diagnosis and discharge instructions.\367\ Nothing has
changed in this regard since the publication of the 2016 Rule; rather,
the COVID-19 pandemic has demonstrated how critical meaningful access
to health programs and activities is for the health and well-being of
LEP individuals. A recent study documented the unique challenges faced
by LEP individuals during the COVID-19 pandemic. The authors explained
that factors like under-interpretation of complex conversations, non-
universal use of interpreters, fewer conversations throughout the day
with staff, not receiving important medical paperwork in their native
language, and being separated from social support networks that often
assist with the navigation of health care systems exacerbated these
challenges for LEP individuals under the social isolation of inpatient
care settings during the strict COVID-19 no visitation policies.\368\
---------------------------------------------------------------------------
\367\ U.S. Dep't Health & Human Servs., Ctrs. for Medicare &
Medicaid Servs., Guide to Preventing Readmissions Among Racially and
Ethnically Diverse Medicare Beneficiaries, p. 4 (Sept. 2015),
https://essentialhospitals.org/wp-content/uploads/2016/01/OMH_Readmissions_Guide.pdf.
\368\ Natale K. Kucirek et al., Stories from COVID-19 Reveal
Hospitalized Patients with Limited English Proficiency Have Always
Been Uniquely Prone to Social Isolation, 36 J. of General Internal
Med. 786, 789 (2021), https://doi.org/10.1007/s11606-020-06383-z.
---------------------------------------------------------------------------
Proposed paragraph (b) states that language assistance services
required under paragraph (a) must be provided free of charge, be
accurate and timely, and protect the privacy and independent decision-
making ability of an LEP individual. This provision is similar to those
included in the 2016 Rule at former Sec. 92.201(c) and the 2020 Rule
at Sec. 92.101(b)(2) and is consistent with longstanding Title VI
requirements and the HHS LEP Guidance.\369\ The Department reminds
states that they have the option to claim Medicaid reimbursement for
the cost of interpretation services, either as medical-assistance or
administration related expenditures.\370\
---------------------------------------------------------------------------
\369\ 68 FR 47316.
\370\ See Translation and Interpretation Services, Ctrs. for
Medicare & Medicaid Servs., https://www.medicaid.gov/medicaid/financial-management/medicaid-administrative-claiming/translation-and-interpretation-services/ (last visited June 15, 2022).
---------------------------------------------------------------------------
Proposed paragraph (c) provides specific requirements for
interpreter and translation services. Proposed paragraph (c)(1) states
that when interpreter services are required under this part, a covered
entity must offer a qualified interpreter. Proposed paragraph (c)(2)
provides that when translation services are required under this part, a
covered entity must use a qualified translator. These terms are defined
in the definitions section at proposed Sec. 92.4.
Proposed paragraph (c)(3) addresses the use of machine translation
by covered entities. Machine translation, which can involve speech-
based machine translation to facilitate patient-provider communication
as well as text-based machine translation to develop multilingual
health materials, is increasingly being used as a method to assist
communication in the health care setting and increase access to in-
language health resources.\371\ While the technology behind machine
translation has improved in accuracy, the possibilities of significant
consequences from inaccurate translation continue to exist.\372\ During
the COVID-19 pandemic, several states and some territories received
complaints from LEP individuals because they were unable to sign up for
COVID-19 vaccines on websites using machine translation or found
translated information confusing because of inaccuracies in some
translations.\373\ The prevalence of inaccuracies was highlighted in a
recent literature review of articles discussing machine translation in
the health care context, which found that no matter the language or
form of machine translation, all studies indicated error rates so high
as to be ``unacceptable for actual deployment in health settings.''
\374\
---------------------------------------------------------------------------
\371\ Kristin N. Dew et al., Development of Machine Translation
Technology for Assisting Health Communication: A Systematic Review,
85 J. of Biomedical Informatics 56, 57 (2018), https://reader.elsevier.com/reader/sd/pii/S1532046418301448?token=D92E78CBB86826ADC483479DED4B8E8442AE77630BCCB53F5385AE5AD2452E7FFC803B8CBA43AC533A509E3F977291BC&originRegion=us-east-1&originCreation=20220615184038.
\372\ See Wenxiu Xie et al., Predicting Risks of Machine
Translations of Public Health Resources by Developing Interpretable
Machine Learning Classifiers, 18 Int. J. Environ. Res. Pub. Health
8789 (2021), https://www.mdpi.com/1660-4601/18/16/8789/htm; Lucas N.
Vieira et al., Understanding the Societal Impacts of Machine
Translation: A Critical Review of the Literature on Medical and
Legal Use Cases, 24 Info., Comm., & Soc'y 1515 (2020), https://www.tandfonline.com/doi/full/10.1080/1369118X.2020.1776370; Nicole
Wetsman, Google Translate Still Isn't Good Enough for Medical
Instructions, The Verge (Mar. 9, 2021), https://www.theverge.com/2021/3/9/22319225/google-translate-medical-instructions-unreliable;
Breena R. Taira et al., A Pragmatic Assessment of Google Translate
for Emergency Department Instructions, 36 J. Gen. Intern. Med. 3361
(2021), https://link.springer.com/article/10.1007%2Fs11606-021-06666-z; Mark P. Sendak et al., A Path for Translation of Machine
Learning Products into Healthcare Delivery, EMJ Innov., Jan. 27,
2021, https://emj.emg-health.com/wp-content/uploads/sites/2/2020/01/A-Path-for-Translation-of-Machine-Learning.....pdf; Dew, supra note
371.
\373\ Julie Zauzmer Weil, DC Says Long-Awaited Translation of
Vaccine Website Is Coming This Weekend, Wash. Post (Apr. 9, 2021),
https://www.washingtonpost.com/local/coronavirus-vaccine-translation-spanish/2021/04/09/40ed126a-9942-11eb-962b-78c1d8228819_story.html.
\374\ Dew, supra note 371, at 64.
---------------------------------------------------------------------------
The Department proposes regulatory language requiring a covered
entity that uses machine translation to have translated materials
reviewed by a qualified human translator when the underlying text is
critical to the rights, benefits, or meaningful access of an LEP
[[Page 47862]]
individual; when accuracy is essential; or when the source documents or
materials contain complex, non-literal, or technical language.
We seek comment on the use of machine translation in health
programs and activities generally, other possible approaches to address
this issue, and whether there should be an exception to this provision
to allow for the limited use of machine translation in exigent
circumstances.
Proposed paragraph (d) addresses how the Director will evaluate
compliance with this section. The 2015 NPRM in then-proposed Sec.
92.201(b)(1) provided that the Director would evaluate a covered
entity's compliance with meaningful access for LEP individuals by
giving substantial weight to the nature and importance of the program
or activity and the particular communication at issue.\375\ The 2015
NPRM also identified five other relevant factors that the Director
would consider.\376\ In response to comments, the preamble to the 2016
Rule eliminated the list of five factors and articulated only one
factor in former Sec. 92.201(b)(2): whether a covered entity had
developed and implemented an effective written language access plan
appropriate to its circumstances.\377\ Commenters suggested many other
factors that could be included.\378\ The preamble explained that
including multiple illustrative factors in the regulatory text may
create the erroneous impression that the Director will not consider
other relevant factors, and trying to capture all possible factors
could result in an unintentionally unworkable regulatory scheme.\379\
Accordingly, the preamble to the 2016 Rule contains a lengthy list of
factors that may be relevant in a particular case, including:
---------------------------------------------------------------------------
\375\ 80 FR 54171, 54218 (Sept. 8, 2015).
\376\ Id.
\377\ 81 FR 31470.
\378\ Id. at 31415.
\379\ Id.
the length, complexity, and context of the communication; the
prevalence of the language in which the individual communicates
among those eligible to be served or likely to be encountered by the
health program or activity; the frequency with which a covered
entity encounters the language in which the individual communicates;
whether a covered entity has explored the individual's preference,
if any, for a type of language assistance service, as not all types
of language assistance services may work as well as others in
providing an individual meaningful access to the covered entity's
health program or activity; the cost of language assistance services
and whether a covered entity has availed itself of cost-saving
opportunities; and all resources available to the covered entity,
including the entity's capacity to leverage resources among its
partners or to use its negotiating power to lower the costs at which
language assistance services could be obtained.\380\
---------------------------------------------------------------------------
\380\ Id. at 31416.
At paragraph (d)(1), we propose that the Director shall evaluate,
and give substantial weight to, the nature and importance of the health
program or activity and the particular communication at issue, to the
LEP individual. This is the same language as was included in the 2016
Rule.\381\ Proposed paragraph (d)(2) provides that the Director shall
take into account other relevant factors, including the effectiveness
of the covered entity's written language access procedures for its
health programs and activities, that the covered entity has implemented
pursuant to proposed Sec. 92.8(d) of this part. In this proposed
regulation, we are not requiring a formal language access plan;
however, we continue to strongly encourage covered entities to develop
such plans, in concert with developing and implementing language access
procedures required under proposed Sec. 92.8(d), to be in a better
position to meet their obligations to provide effective language
services in a timely manner.
---------------------------------------------------------------------------
\381\ Former 45 CFR 92.201(b)(1).
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The proposed language contrasts with the 2020 Rule which, at Sec.
92.101(b)(1), provides that the Director will assess how the covered
entity balances four factors,\382\ essentially adopting the ``four-
factor analysis'' found in the HHS LEP Guidance.\383\ The preamble to
the 2020 Rule notes that ``some commenters believed that the four-
factor analysis under Sec. 92.101(b) is too broad, lacks clarity, does
not ensure that translation and other language services are available
under important medical circumstances, may require recipients to
provide unnecessarily expensive services, and weakens recipient
language access obligations to serve persons who speak infrequently
encountered languages.'' \384\ The 2020 Rule preamble states that OCR
viewed the four-factor analysis as an appropriate way ``to allow
flexibility for covered entities.'' \385\
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\382\ See 85 FR 37245.
\383\ 68 FR 47311, 47314 (Aug. 8, 2003) (suggesting, as a
starting point for covered entities meeting their obligations, the
balancing of four factors: (1) the number or proportion of LEP
persons eligible to be served or likely to be encountered by the
program or grantee; (2) the frequency with which LEP individuals
come in contact with the program; (3) the nature and importance of
the program, activity, or service provided by the program to
people's lives; and (4) the resources available to the grantee/
recipient and costs).
\384\ 85 FR 37212.
\385\ Id.
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During the four years that these provisions of the 2016 Rule were
in effect, former Sec. 92.201(a) was never challenged. However, the
standard contained in the 2020 Rule has been challenged in Federal
district court. In Chinatown Service Center, plaintiffs alleged that
the 2020 Rule's replacement of the standard in former Sec. 92.201(a)
resulted in only a ``generalized duty'' to LEP individuals rather than
a case-by-case review to ensure the covered entities take reasonable
steps to provide each individual with limited English proficiency with
necessary language assistance services.\386\
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\386\ See Chinatown Serv. Ctr. Compl., supra note 309.
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After reviewing and reconsidering comments received in response to
the 2019 NPRM, we believe that the four-factor analysis is more
appropriately described as a general framework for planning on a
system-wide and site-level basis, but does not provide clarity as to
what the covered entity's obligations are to a particular individual.
The proposed rule applies the general obligation to take reasonable
steps to provide meaningful access and focuses on the steps the covered
entity must take for each individual in the health care setting.
The level of specificity we propose is especially important when
addressing benefits or services with high importance or consequences
such as those provided in the health care setting. This specificity
helps guide a covered entity by supplying a framework that they can
choose to use, while providing a covered entity an appropriate level of
flexibility to determine how best to comply with statutory and
regulatory obligations to provide meaningful access to LEP individuals.
Therefore, while we have taken the four-factor analysis into
consideration in formulating the specific provisions, we decline to
include it in this proposed regulation. We seek comment on this
approach.
Proposed paragraph (e) identifies restrictions on the use of
certain persons to provide language assistance services for LEP
individuals. This language is similar to that contained in the 2020
Rule at Sec. 92.101(b)(4), with additional descriptors to ensure the
best available and most accurate language assistance services in
covered health programs and activities.\387\ Proposed paragraph (e)(1)
prohibits covered entities from requiring LEP individuals to provide,
or pay for,
[[Page 47863]]
their own interpreters. Proposed paragraph (e)(2) provides for very
limited situations in which an adult, not qualified as an interpreter,
accompanying an LEP individual can serve as an interpreter. The first
limited circumstance includes an emergency involving an imminent threat
to the safety or welfare of an individual or the public where there is
no qualified interpreter for the LEP individual immediately available.
For example, directly following a natural disaster such as an
earthquake, a covered entity may temporarily rely on a non-qualified
interpreter to help first responders provide services to LEP
individuals during emergency response and recovery efforts. This is
permitted only as a temporary measure while finding a qualified
interpreter, and the qualified interpreter that arrives must confirm or
supplement the initial communications with the accompanying adult.
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\387\ 85 FR 37246.
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In the second limited circumstance, an adult who is not qualified
as an interpreter may also serve as an interpreter when: an LEP
individual specifically requests that the accompanying adult interpret
or facilitate communication; the accompanying adult agrees to provide
such assistance; the request and agreement by the accompanying adult is
documented; and reliance on that adult for such assistance is
appropriate under the circumstances. When considering whether the
reliance on such an adult to interpret without confirming or
supplementing the interpretation is appropriate, the covered entity
should consider the accompanying adult's language proficiency in both
English and the primary language of the LEP individual; the possibility
of bias; whether the individual is an interested party, such as in
situations of domestic violence; and whether the accompanying adult
helps the covered entity better understand the LEP individual. Covered
entities should also keep in mind that untrained ``interpreters'' are
more likely to make errors, violate confidentiality, and increase the
risk of poor outcomes.\388\ If the covered entity is unable to make the
required assessment, relying on the accompanying adult is
inappropriate.
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\388\ Gregory Juckett & Kendra Unger, Appropriate Use of Medical
Interpreters, 90 A. Fam. Physician 476 (2014), https://www.aafp.org/pubs/afp/issues/2014/1001/p476.html.
---------------------------------------------------------------------------
Proposed paragraph (e)(3) prohibits a covered entity from relying
on a minor child to interpret or facilitate communication, except as a
temporary measure while finding a qualified interpreter in an emergency
involving an imminent threat to the safety or welfare of an individual
or the public where there is no qualified interpreter for the LEP
individual immediately available--for example, directly following a
serious car accident where, due to the nature of the injuries
sustained, an LEP individual's critical care is a priority. Once the
qualified interpreter has arrived, they must confirm or supplement the
initial communications with the minor child. The use of children as
interpreters raises the same concerns as those of an accompanying adult
who is not qualified as an interpreter, but also poses other problems
including exposing children to complex health care interactions for
which they are not developmentally prepared, upsetting a family power
dynamic, causing embarrassment, and conveying incorrect or incomplete
information.\389\
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\389\ See, e.g., Sunmin Lee et al., Barriers to Health Care
Access in 13 Asian American Communities, 45 Am. J. Health Behav. 21,
22 (2010), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6628721/;
Wooksoo, supra note 106, at 289.
---------------------------------------------------------------------------
Proposed paragraph (e)(4) prohibits reliance on staff other than
qualified interpreters, qualified translators, or qualified bilingual
or multilingual staff to communicate directly with LEP individuals.
Proposed paragraph (f) addresses standards for video remote
interpreting (VRI) and is identical to former Sec. 92.201(f) in the
2016 Rule.\390\ The preamble to that rule states the purpose of
developing VRI standards was to address concerns that the use of this
technology may result in less comprehensible communication. The 2016
Rule preamble also explains that the VRI standards are designed to
achieve parity with the regulation in the disability rights
context.\391\ These standards closely parallel those standards set
forth in proposed Sec. 92.202 regarding effective communication for
individuals with disabilities, which, similar to the 2016 Rule, relies
on standards in Title II of the ADA for the use of sign language
interpreters.
---------------------------------------------------------------------------
\390\ 81 FR 31375, 31470-71 (May 18, 2016).
\391\ Id. at 31418.
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The 2020 Rule does not address VRI services. The preamble explains
that in place of VRI standards, the final rule adopts the four-factor
analysis ``which will help covered entities balance competing
considerations related to VRI quality standards.'' \392\ The 2020 Rule
RIA states that ``the burden of requiring covered entities to provide
video technology training and utilize expensive software does not
appear to be justified based on minimal benefit to language speakers
who can effectively communicate when there is a clear audio
transmission through the remote interpreting service.'' \393\ The
Department disagrees with this assessment. Performance standards are
necessary so that VRI technologies do not result in ineffective
communication. The plain terms of this provision do not require a
covered entity to provide VRI but rather ensure that when such services
are used, they must meet a quality standard.
---------------------------------------------------------------------------
\392\ 85 FR 37213.
\393\ Id. at 37223.
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Proposed paragraph (g) sets forth standards for audio remote
interpreting services. Those standards, which are likewise important in
order to have meaningful communication, are identical to those in the
2020 Rule at Sec. 92.101(b)(3)(iii).\394\
---------------------------------------------------------------------------
\394\ Id. at 37246.
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Proposed paragraph (h) states that nothing in this section shall be
construed to require an LEP individual to accept language assistance
services. Identical language is contained in the 2020 Rule at Sec.
92.101(c), and the 2016 Rule at former Sec. 92.101(g).\395\
---------------------------------------------------------------------------
\395\ Id.
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Effective Communication for Individuals With Disabilities (Sec.
92.202)
Proposed Sec. 92.202 addresses requirements related to providing
effective communication for individuals with disabilities. The 2020
Rule at Sec. 92.102 and the 2016 Rule at former Sec. 92.202 contain
substantially the same requirements as this proposed section.
In proposed paragraph (a), we require a covered entity to take
appropriate steps to ensure that communications with individuals with
disabilities, and companions with disabilities, are as effective as
communications with individuals without disabilities in its health
programs and activities, incorporating the standards found at 28 CFR
35.130 and 35.160 through 35.164 of the regulation implementing Title
II of the ADA. Proposed paragraph (a) is similar to the 2020 Rule at
Sec. 92.102(a), with the addition of ``companions'' to codify the
Department's longstanding position that a covered entity's obligation
to ensure effective communication extends not just to individuals with
disabilities but to companions as well, if they are individuals with
disabilities.\396\
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\396\ Consistent with the Department's position in the 2016
Rule; 42 U.S.C. 12182(b)(1)(E)(Title III); 28 CFR 35.130(g) (Title
II). See generally, U.S. Equal Emp't Opportunity Comm'n, Questions &
Answers: Association Provision of the ADA (Oct. 17, 2005), https://www.eeoc.gov/laws/guidance/questions-answers-association-provision-ada; cf. Loeffler v. Staten Island Univ. Hosp., 582 F.3d 268, 277
(2d Cir. 2009) (permitting associational discrimination claim under
Section 504); Falls v. Prince George's Hosp. Ctr., No. Civ. A 97-
1545, 1999 WL 33485550, at *11 (D. Md. Mar. 16, 1999) (holding that
parent had an associational discrimination claim under Section 504
when hospital required hearing parent to act as interpreter for
child who was deaf).
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[[Page 47864]]
Because we propose to incorporate all of the relevant Title II
standards into proposed paragraph (a), including requirements that were
enumerated in the 2020 Rule (e.g., the requirements to provide
auxiliary aids and services in a timely manner and free of charge, and
to give primary consideration to the requests of individuals with
disabilities when determining what types of auxiliary aids and services
are necessary), we do not propose to enumerate these specific
additional standards in this rule. This proposed section also clarifies
that where the regulatory provisions referenced in this section use the
term ``public entity,'' the term ``covered entity'' shall apply in its
place.
We propose in paragraph (b) to explicitly require covered entities
to provide appropriate auxiliary aids and services to individuals with
impaired sensory, manual, or speaking skills, where necessary to afford
such individuals an equal opportunity to benefit from the service in
question. Once again, this paragraph is substantially similar to the
2020 Rule at Sec. 92.102(b), which applied to recipients and State
Exchanges. Because all covered entities, including the Department, are
required to provide auxiliary aids and services, we propose to apply
paragraph (b) to all covered entities, not just recipients and State
Exchanges.\397\
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\397\ The Department is required to provide appropriate
auxiliary aids and services under 45 CFR 85.51(a)(1) of this
subchapter, which is incorporated by reference under proposed Sec.
92.101(b)(1)(ii).
---------------------------------------------------------------------------
We also note that in order to ensure a covered entity meets its
obligations to provide both meaningful access and effective
communication for LEP individuals with disabilities, it must comply
with both proposed Sec. 92.201 and proposed Sec. 92.202. Auxiliary
aids and services that are not provided in a language consistent with
proposed Sec. 92.201 do not satisfy the requirements of proposed Sec.
92.202. For example, a covered entity that only offered auxiliary aids
and services in English to an LEP individual with a disability may be
in violation of both proposed Sec. 92.201 and Sec. 92.202.
The 2020 Rule defines ``disability,'' ``auxiliary aids and
services'' and ``qualified interpreter'' at Sec. 92.201; those
definitions are now located in proposed Sec. 92.4.
Accessibility for Buildings and Facilities (Sec. 92.203)
Proposed Sec. 92.203 adds a general provision establishing that no
qualified individual with a disability shall, because a covered
entity's facilities are inaccessible to or unusable by individuals with
disabilities, be denied the benefits of, be excluded from participation
in, or otherwise be subjected to discrimination under any health
program or activity to which this part applies, consistent with the
Department's Section 504 regulation covering federally assisted and
federally conducted programs and activities.\398\ The remainder of
proposed Sec. 92.203 incorporates the identical language found in the
2020 Rule at Sec. 92.103, except that the definitions for ``1991
Standards,'' ``2010 Standards,'' and ``UFAS'' are now located in
proposed Sec. 92.4.
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\398\ 45 CFR 84.21 (federally assisted); Sec. 85.41 (federally
conducted).
---------------------------------------------------------------------------
Accessibility of Information and Communication Technology for
Individuals With Disabilities (Sec. 92.204)
Proposed Sec. 92.204 addresses the accessibility of information
and communication technology (ICT) for individuals with disabilities.
This proposed section is substantially the same as Sec. 92.104(a)-(b)
of the 2020 Rule and former Sec. 92.204 of the 2016 Rule. The 2020
Rule also defines ``information and communication technology'' at Sec.
92.104(c), which we propose to define at proposed Sec. 92.4.
With the advent of COVID-19 constraints placed on in-person
services, the use of technology has become ever more critical. Covered
entities have adapted creatively utilizing remote communications
technologies to provide telehealth services, including audio, text
messaging or video conferencing. Additionally, websites and online
portals are serving as primary registration vehicles for obtaining
COVID-19 tests and vaccines. In some instances, however, the use of
inaccessible websites or online portals has resulted in access barriers
for individuals with disabilities. For example, individuals with vision
impairments who use screen reader software or persons with mobility
impairments who have difficulty using a mouse, may not be able to
access inaccessible online registration forms or navigate inaccessible
vaccine websites.\399\
---------------------------------------------------------------------------
\399\ See e.g., Press Release, U.S. Dep't of Just., Justice
Department Secures Settlement with Rite Aid Corporation to Make Its
Online Covid-19 Vaccine Portal Accessible to Individuals with
Disabilities (Nov. 1, 2021), https://www.justice.gov/usao-mdpa/pr/justice-department-secures-settlement-rite-aid-corporation-make-its-online-covid-19.
---------------------------------------------------------------------------
Many covered entities are currently relying on Section 508
standards promulgated by the Access Board or Web Content Accessibility
Guidelines (WCAG) developed through the Worldwide Web Consortium's
(W3C) Web Accessibility Initiative to ensure that their ICT is
accessible to individuals with disabilities.\400\ Additionally,
multiple states have laws or policies addressing accessibility of ICT
with which entities covered by those statutes must comply.\401\ Over
time, the feasibility of technological applications and solutions has
continued to develop and dramatically change the way the public
interacts with health programs and activities.
---------------------------------------------------------------------------
\400\ See Press Release, U.S. Dep't of Just., Justice Department
Issues Web Accessibility Guidance Under the Americans with
Disabilities Act (Mar. 18, 2022), https://www.justice.gov/opa/pr/justice-department-issues-web-accessibility-guidance-under-americans-disabilities-act.
\401\ Policy & Management: State Policy, Section508.gov, https://www.section508.gov/manage/laws-and-policies/state/ (last visited
June 15, 2022).
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Proposed paragraph (a) requires covered entities to ensure that
their health programs and activities provided through ICT are
accessible to individuals with disabilities, unless doing so would
result in undue financial and administrative burdens or a fundamental
alteration in the nature of the health programs or activities. If an
action required to comply with this subpart would result in such an
alteration or burdens, a covered entity is required to take any other
action that would not result in such an alteration or burdens but would
nevertheless enable, to the maximum extent possible, individuals with
disabilities to receive the benefits or services of the health program
or activity provided by the covered entity.
Proposed paragraph (b) requires recipients and State Exchanges to
ensure that their health programs and activities provided through
websites and mobile applications comply with the requirements of
Section 504 as interpreted in a manner consistent with Title II of the
ADA. Both the 2020 Rule and the 2016 Rule have the same provision as it
applies to recipient and State Exchange websites. We propose to modify
this provision by extending it to mobile applications in addition to
websites.
Given the heightened impact ICT has on individuals with
disabilities in health programs and activities, as
[[Page 47865]]
evidenced by COVID-19, OCR is seeking comments on whether the Section
1557 rule should include a provision requiring covered entities to
comply with specific accessibility standards, such as the Web Content
Accessibility Guidelines (WCAG) developed by the Web Accessibility
Initiative. Additionally, OCR seeks comments on whether to adopt a safe
harbor provision under which covered entities that are in compliance
with established specific accessibility standards are deemed in
compliance with proposed paragraphs (a) and (b) of this section;
whether OCR should require covered entities to comply with the most
recent edition of a published standard; and the timeline necessary for
covered entities to come into compliance with a new standard.
Requirement To Make Reasonable Modifications (Sec. 92.205)
Proposed Sec. 92.205 requires covered entities to make reasonable
modifications to policies, practices, or procedures when such
modifications are necessary to avoid discrimination on the basis of
disability, unless the covered entity can demonstrate that making the
modifications would fundamentally alter the nature of the health
program or activity. This provision is the same as Sec. 92.105 of the
2020 Rule and former Sec. 92.205 of the 2016 Rule. For the purposes of
this section, the term ``reasonable modifications'' shall be
interpreted in a manner consistent with the term as set forth in the
regulation implementing Title II of the ADA at 28 CFR
35.130(b)(7).\402\
---------------------------------------------------------------------------
\402\ See discussion supra Sec. 92.3 (addressing need for
parity between Section 504 and the ADA).
---------------------------------------------------------------------------
Equal Program Access on the Basis of Sex (Sec. 92.206)
The Department proposes to include a section clarifying covered
entities' obligation to ensure equal access to their health programs
and activities without discrimination on the basis of sex, including
pregnancy, sexual orientation, gender identity, and sex
characteristics.\403\ This provision primarily relates to covered
entities that are directly engaged in the provision of health care
services, such as hospitals, physical and mental health care providers,
and pharmacies. While the 2016 Rule included a section on equal program
access on the basis of sex, the 2020 Rule does not include an analogous
provision. As Section 1557 is the only Federal civil rights law
explicitly prohibiting sex discrimination in health programs and
activities, the Department believes that it is beneficial to both
covered entities and the public to have additional regulatory clarity.
Nondiscrimination by covered entities in the provision or
administration of health insurance coverage and other health-related
coverage is addressed in proposed Sec. 92.207.
---------------------------------------------------------------------------
\403\ See discussion supra section II.B. (The 2020 Rule's
Preamble Does Not Reflect Recent Developments in Civil Rights Law).
---------------------------------------------------------------------------
Proposed Sec. 92.206(a) describes a covered entity's general
obligation to provide individuals equal access to the covered entity's
health programs or activities without discrimination on the basis of
sex. The Department proposes paragraphs (b)(1)-(4) to clarify certain
types of discriminatory actions that would be prohibited for a covered
entity in its provision of access to health programs or activities.
As is true for any claim of discrimination under this proposed
rule, and consistent with the Department's standard practice for
investigating such claims, OCR may use the tools of longstanding civil
rights case law in analyzing claims of discrimination under paragraph
(b). These tools include, but are not limited to, the multi-factor test
articulated in Arlington Heights,\404\ and the McDonnell Douglas \405\
burden-shifting framework. Explained in great depth in the DOJ's Title
VI Legal Manual, Arlington Heights is a method of proof that uses a
number of different types of circumstantial evidence that, taken
collectively, can demonstrate that the covered entity acted, at least
in part, because of a protected basis. Under this test, evidence of
disparate impact can be one piece of evidence that is considered in
determining whether there is intentional discrimination. This framework
is most commonly applied in cases alleging discrimination against a
group.\406\ The McDonnell Douglas burden-shifting framework, however,
is most commonly applied in cases alleging discrimination in individual
instances and is an inferential method of proof that is used to show
that a defendant treated similarly situated individuals differently
because of a protected basis.\407\ Under McDonnell Douglas, where there
is a prima facie case of discrimination against a covered entity, that
covered entity must articulate a legitimate, nondiscriminatory reason
for its actions. This legitimate, nondiscriminatory reason would be a
defense against the claim of discrimination, unless it can be
established that this reason is in fact a mere pretext for prohibited
discrimination.
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\404\ Vill. of Arlington Heights v. Metro. Housing Dev. Corp.,
429 U.S. 252, 266-68 (1977).
\405\ McDonnell Douglas Corp. v. Green, 411 U.S. 792 (1973).
\406\ U.S. Dep't of Just., Title VI Legal Manual, sec. VI.B.2.
\407\ Id. at sec. VI.B.3.
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Proposed paragraph (b)(1) provides a general prohibition on the
denial or limitation of health services, including those that are
offered exclusively to individuals of one sex, to an individual based
on the individual's sex assigned at birth, gender identity, or gender
otherwise recorded. The text of this proposed paragraph is similar to
former Sec. 92.206 of the 2016 Rule, which provided that ``a covered
entity may not deny or limit health services that are ordinarily or
exclusively available to individuals of one sex, to a transgender
individual based on the fact that the individual's sex assigned at
birth, gender identity, or gender otherwise recorded is different from
the one to which such health services are ordinarily or exclusively
available.'' \408\ The 2020 Rule does not include a similar provision.
The Department proposes to not include the word ``transgender'' in this
proposed provision. This approach recognizes that the form of
discrimination discussed herein may impact a range of individuals,
including transgender people, individuals with intersex conditions, or
people who may need these services but do not identify as transgender.
---------------------------------------------------------------------------
\408\ See 81 FR 311375, 31471 (May 18, 2016).
---------------------------------------------------------------------------
The Department's review of the literature indicates that this
provision is warranted based on continued discrimination experienced by
transgender and gender non-conforming individuals as they seek basic
medical care. For example, transgender men who are pregnant experience
significant forms of ``discrimination, stigma, and erasure'' when
navigating pregnancy and prenatal care, particularly because pregnancy
and childbirth are often treated as something exclusively experienced
by cisgender women.\409\
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\409\ Margaret Besse et al., Experiences with Achieving
Pregnancy and Giving Birth Among Transgender Men: A Narrative
Literature Review, 93 Yale J. of Biology & Med. 517, 518 (2020).
---------------------------------------------------------------------------
Under this provision, a covered entity that routinely provides
gynecological or obstetric care could not deny an individual a pelvic
exam or pregnancy-related care because the individual is a transgender
man or nonbinary person assigned female at birth, if the entity
otherwise provides that care to cisgender individuals. Similarly, a
community clinic that receives funding from the Department could not
refuse to provide a transgender woman a prostate cancer screening
because her sex is
[[Page 47866]]
listed female in her electronic health record, if the entity otherwise
provides these screenings to cisgender individuals.
Proposed paragraph (b)(2) prohibits covered entities from denying
or limiting a health care professional's ability to provide health
services on the basis of a patient's sex assigned at birth, gender
identity, or gender otherwise recorded. This provision recognizes that
prohibited discrimination may take the form of attempted restrictions
on individual providers, such as attending physicians, that have the
effect of discriminating against patients, in addition to
discriminatory actions that target patients directly. This is similar
to Title VI's limited application to employment when a recipient's
``discrimination has a secondary effect on the ability of beneficiaries
to participate meaningfully in and/or receive the benefits of a
federally assisted program in a nondiscriminatory manner.'' \410\
---------------------------------------------------------------------------
\410\ U.S. Dep't of Just., Title VI Legal Manual, sec. X.A.
---------------------------------------------------------------------------
Under this provision, a covered entity is also prohibited from
punishing or disciplining a provider for providing clinically
appropriate care where doing so would have the impact of limiting that
provider's ability to provide such care on the basis of a patient's
assigned sex at birth, gender identity, or gender otherwise recorded.
As with all proposed paragraphs in this section, this provision does
not require covered entities to perform services outside of their
specialty area. However, restrictions by covered entities on the
ability of providers to prescribe or provide care based on their
patient's gender identity or sex assigned at birth would likely
constitute prohibited discrimination in violation of this rule.
Proposed paragraph (b)(3) would prohibit a covered entity from
applying any policy or practice of treating individuals differently or
separating them on the basis of sex in a manner that subjects any
individual to more than de minimis harm. The 2016 Rule provided, at
former Sec. 92.101(b)(3)(iv), that sex-specific health programs and
activities were allowable only where the covered entity could
``demonstrate an exceedingly persuasive justification, that is, that
the sex-specific health program or activity is substantially related to
the achievement of an important health-related or scientific
objective.'' The 2020 Rule repealed this provision, finding that the
provision ``placed an unjustified burden on sex-specific health
programs and activities conducted by private entities'' by adopting the
Equal Protection standard that otherwise applies only to governmental
actions that discriminate on the basis of sex.\411\ The Department has
considered the approaches taken in the 2016 and 2020 Rules and believes
that while it is important to include a provision on this issue, the
Constitutional standard is not the most appropriate for a regulation
that applies to governmental and non-governmental actors. Rather, we
believe the standard proposed now is the more appropriate approach.
---------------------------------------------------------------------------
\411\ 85 FR 37160, 37196 (June 19, 2020).
---------------------------------------------------------------------------
Although differential treatment on the basis of sex is generally
prohibited, the Department acknowledges that there are certain
circumstances in which Section 1557 does not prohibit separation by sex
or differential medical treatment on the basis of sex, namely, where it
does not cause more than de minimis harm. A sex-based distinction that
has only a minimal impact is not a form of ``discrimination'' that
Congress intended to prohibit,\412\ and an individual shall not be
deemed subject to discrimination under this part by reason of the fact
that an otherwise lawful health program or activity has chosen to
utilize such sex-based distinctions consistent with the requirements of
this rule. For example, the practice of assigning patients to dual-
occupancy rooms in hospitals and in-patient treatment facilities on the
basis of sex is not, standing alone, a form of discrimination.
---------------------------------------------------------------------------
\412\ See, e.g., Oncale v. Sundowner Offshore Servs., Inc., 523
U.S. 75, 81 (1998) (Title VII does not reach non-harmful
``differences in the ways men and women routinely interact with''
each other); see also Burlington N. & Santa Fe Ry. Co. v. White, 548
U.S. 53, 59-60 (2006) (``No one doubts that the term `discriminate
against' refers to distinctions or differences in treatment that
injure protected individuals.''); Threat v. City of Cleveland, 6
F.4th 672, 678 (6th Cir. 2021) (``To `discriminate' reasonably
sweeps in some form of an adversity and a materiality threshold.'').
---------------------------------------------------------------------------
However, the Department may still find that a covered entity
violates Section 1557 if it implements the sex-based distinction in a
way that constitutes discrimination, by imposing more than de minimis
harm upon a particular individual. This is what Title IX requires.\413\
---------------------------------------------------------------------------
\413\ See Peltier v. Charter Day Sch., Inc., Nos. 20-1001, 20-
1023, 2022 WL 2128579, at *16 (4th Cir. June 14, 2022) (en banc)
(``for the plaintiffs to prevail under Title IX, they must show that
. . . the challenged action caused them harm, which may include
`emotional and dignitary harm' '' (internal citation omitted)).
---------------------------------------------------------------------------
Discriminatory harm that is more than de minimis may include any
adverse effect on a person's equal access to or participation in a
covered entity's health program or activity based on sex. This
provision does not, however, prohibit a covered entity from treating an
individual for conditions that may be specific to their sex
characteristics. For example, it would be permissible for an emergency
department to treat a transgender man with a positive human chorionic
gonadotropin (pregnancy) test as a pregnant person, even though
pregnancy is generally associated with ``female'' sex characteristics,
such as having a functioning uterus and ovaries.\414\ Similarly, sex-
specific clinical trials may be permissible based upon the scientific
purposes of the study, i.e., trials based on a particular sex-
characteristic(s), such as those that test treatments for specific
conditions or that evaluate differences in responses to treatment
regimens among individuals with different sex characteristics. In
evaluating a complaint of discrimination challenging a covered entity's
sex-specific health program or activity, OCR may consider a variety of
factors relevant to the particular health program or activity.
---------------------------------------------------------------------------
\414\ See, e.g., Daphna Strousma et al., The Power and Limits of
Classification--A 32-Year-Old Man with Abdominal Pain, 380 N. Eng.
J. Med. 1885 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7395710/pdf/nihms-1609250.pdf.
---------------------------------------------------------------------------
In particular, this provision would prohibit the adoption of a
policy, or engaging in a practice, that prevents any individual from
participating in a covered entity's health program or activity
consistent with their gender identity. The 2016 Rule required that
covered entities ``treat individuals consistent with their gender
identity'' at former Sec. 92.206; as discussed previously, the 2020
Rule preamble indicated that Section 1557 likely did not prohibit
discrimination on the basis of gender identity as a form of prohibited
sex discrimination, and therefore did not include a similar provision.
The Department believes this provision is necessary to better
effectuate Section 1557's purpose: to eliminate sex discrimination in a
range of health programs and activities. Reading Section 1557's
prohibition of sex discrimination consistently with the reasoning in
Bostock, discrimination on the basis of gender identity necessarily
involves consideration of an individual's sex--even if that term is
narrowly defined--and Section 1557's prohibition covers discrimination
on that basis. For example, a hospital that assigns patients to dual-
occupancy rooms based on sex would be prohibited from requiring a
transgender woman to share a room with a cisgender man,
[[Page 47867]]
regardless of how her sex is recorded in her insurance or medical
records.\415\
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\415\ See, e.g., Bulletin, U.S. Dep't of Health & Human Servs.,
The Brooklyn Hospital Center Implements Non-Discriminatory Practices
to Ensure Equal Care for Transgender Patients (July 14, 2015),
https://www.hhs.gov/sites/default/files/ocr/civilrights/activities/agreements/TBHC/statement.pdf.
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Proposed paragraph (b)(4) prohibits a covered entity from denying
or limiting health services sought for the purpose of gender-affirming
care that the covered entity would provide to a person for other
purposes if the denial or limitation is based on a patient's sex
assigned at birth, gender identity, or gender otherwise recorded.
This preamble generally uses the phrase ``gender transition or
gender-affirming care.'' Relevant clinical guidelines acknowledge that
not all individuals for whom such care is clinically appropriate will
specifically identify as transgender, nor will all gender-affirming
care specifically be related to transition from one binary gender to
another.\416\ For example, people seeking gender-affirming care may
refer to their gender identity using terms other than ``transgender,''
such as ``nonbinary,'' ``gender nonconforming,'' ``genderqueer,'' or
``genderfluid.'' Individuals using any of these terms may have a gender
dysphoria diagnosis and seek clinically appropriate gender-affirming
care. A person's use of particular identity terminology is not
determinative of whether the care in question is appropriate.
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\416\ WPATH Standards, supra note 139, at pp. 8-9.
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There also may be variations in the types of health services that
are sought or are clinically appropriate for each person (e.g., some
people undergo hormone therapy as part of gender transition but do not
seek any surgical care).\417\ Additionally, some transgender people
might not seek or require health interventions as part of their gender
transition or gender-affirmation process. Nothing in this preamble or
the regulatory text is intended to limit the application of provisions
discussing gender-affirming care or transition-related care based on
whether an individual uses particular terms to describe their gender
identity or seeks only certain types of gender-affirming or transition-
related care. The Department welcomes comments on this choice of
terminology in the regulatory text, particularly from individuals
seeking and providing such care.
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\417\ Id.
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Importantly, this provision does not require health care
professionals to perform services outside of their normal specialty
area; therefore a provider that declines to provide services outside
its specialty area would have a legitimate, nondiscriminatory reason
for its action. This is consistent with the Department's position under
Section 504 regarding medical specialization. As explained in Appendix
A to the Department's Section 504 implementing regulation, ``[a] burn
treatment center need not provide other types of medical treatment to
[individuals with disabilities] unless it provides such medical
services to [persons without disabilities]. It could not, however,
refuse to treat the burns of a deaf person because of his or her
deafness.'' \418\ This provision also does not compel a provider to
prescribe a specific treatment that the provider decides not to offer
after making a nondiscriminatory bona fide treatment decision. For
example, a family practice covered by the rule would not be required to
provide transition-related surgery where surgical care is not within
its normal area of practice. Nor would the proposed rule require a
pediatrician to prescribe hormone blockers for a prepubescent gender-
nonconforming minor if that health care provider concluded, pursuant to
a nondiscriminatory bona fide treatment decision, that social
transition was the clinically indicated next step for that child.
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\418\ See 45 CFR pt. 84, app. A, subpt. F.
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By contrast, a gynecological surgeon may be in violation of the
rule if they accept a referral for a hysterectomy but later refuse to
perform the surgery upon learning the patient is a transgender man. If
OCR were to receive a complaint in a case such as this, it would
evaluate whether the provider had a legitimate basis for concluding
that the surgery would not be clinically appropriate for the patient.
If the surgeon invokes such a justification, OCR would make a
determination as to whether the reason was a pretext for
discrimination. OCR would also consider the application of Federal
conscience and religious freedom laws, where relevant.
Proposed paragraph (c) provides that nothing in this section
requires the provision of any health service where the covered entity
has a legitimate, nondiscriminatory reason for denying or limiting that
service, including where the covered entity reasonably determines that
such health service is not clinically appropriate for that particular
individual. However, a provider's view that no gender transition or
other gender-affirming care can ever be beneficial for such individuals
(or its compliance with a state or local law that reflects a similar
judgment) is not a sufficient basis for a judgment that a health
service is not clinically appropriate. Paragraph (c) is consistent with
the general principle in nondiscrimination law that covered entities
facing allegations of discrimination have the opportunity to articulate
a legitimate, nondiscriminatory basis for their challenged action or
practice.\419\ For example, a covered entity would not be required to
perform a cervical exam on an individual who does not have a cervix, or
to perform a prostate exam on an individual who does not have a
prostate.
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\419\ See, e.g., McDonnell Douglas Corp. v. Green, 411 U.S. 792,
802 (1973); U.S. Dep't of Just., Title IX Legal Manual, sec. IV.A.1;
id. at sec. VI.B.3; see also Vill. of Arlington Heights v. Metro.
Hous. Dev. Corp., 429 U.S. 252 (1977) (enumerating factors to be
considered in evaluating whether a policy or practice is motivated
by discriminatory intent); U.S. Dep't of Just., Title VI Legal
Manual, sec. VI.B.2.
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In evaluating whether a facially sex-neutral asserted basis is
pretextual, OCR may consider whether a determination that care is not
clinically appropriate is based on generally accepted scientific or
medical standards. For example, a clinic could not raise a defense
under this provision if they denied a transgender woman a prostate exam
based on the provider's belief that prostate exams are never clinically
appropriate for women, if in fact the particular patient has a
prostate. Nor would this provision provide a defense to a provider
denying testosterone therapy to an intersex woman with complete
androgen insensitivity syndrome based on a categorical belief that such
therapy is never clinically appropriate for women.\420\
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\420\ See Wiebke Birnbaum et al., Oestrogen Versus Androgen in
Hormone-Replacement Therapy for Complete Androgen Insensitivity
Syndrome: A Multicentre, Randomised, Double-Dummy, Double-Blind
Crossover Trial, 10 Lancet Diabetes Endocrinol. 771 (2018), https://pubmed.ncbi.nlm.nih.gov/30075954/.
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Similarly, OCR recognizes that providers often need to make
inquiries about a patient's sex-related medical history, health status,
or physical traits related to sex in the course of providing care. Such
inquiries are not per se discriminatory, even where they touch on
intimate or sensitive matters, but should be related to the underlying
condition. For example, it is not discriminatory--i.e., it does not
result in more than de minimis harm--for a provider treating a patient
presenting with symptoms consistent with an ectopic pregnancy to
inquire about the possibility that the patient could be pregnant,
regardless of that patient's gender identity. However, where they are
relevant to allegations of
[[Page 47868]]
discrimination, OCR may consider whether such inquiries are related to
providing the care sought. Where such inquiries do not have a
relationship to the care provided, or where they are made in a manner
that is harassing, hostile, or evinces disregard for a patient's
privacy, OCR may consider whether a provider's inquiries may be
evidence of discrimination. For example, if a provider refused to
provide treatment for a broken arm unless the patient answered
questions about their history of genital surgery, OCR would consider
whether there was any medical rationale for asking the question or
whether it was mere pretext for discrimination, given the lack of
connection between the question and the care being provided.\421\
Similarly, a provider's repeated questions about whether a patient had
had breast augmentation surgery could be considered as evidence of
discrimination where such questions were unrelated to the care
provided, especially if the manner of the questioning had other indicia
of harassment. Where relevant, OCR will consider the totality of the
circumstances in determining whether overbroad, irrelevant, or hostile
inquiries may constitute evidence of discrimination.
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\421\ See, e.g., David Oliver, `Being Transgender Is Not a
Medical Condition': The Meaning of Trans Broken Arm Syndrome, USA
Today (last updated Mar. 31, 2022), https://www.usatoday.com/story/life/health-wellness/2021/07/27/trans-broken-arm-syndrome-what-it-how-combat-discrimination-health-care/8042475002/; Douglas Knutson
et al., ``Trans Broken Arm'': Health Care Stories from Transgender
People in Rural Areas, 7 J. of Rsch. on Women & Gender 30 (2016),
https://journals.tdl.org/jrwg/index.php/jrwg/article/download/97/50.
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Proposed paragraph (d) provides that the enumeration of specific
forms of discrimination in paragraph (b) does not limit the general
applicability of the prohibition in paragraph (a) of this section.
The Department believes that the provisions in proposed Sec.
92.206 are consistent with, and in furtherance of, Section 1554 of the
ACA, which prohibits the Secretary of HHS from promulgating a
regulation that ``interferes with communications regarding a full range
of treatment options between patient and the provider,'' or ``restricts
the ability of health care providers to provide full disclosure of all
relevant information to patients making health care decisions.'' \422\
The provision as written supports and encourages health care providers'
ability to discuss a full range of treatment options with their
patients and in no way restricts providers' ability to share the range
of risks and benefits associated with each treatment option. As
discussed throughout this section, the provisions here do not compel a
particular treatment for any given condition; rather, this section
prohibits health care providers from discriminating against individuals
on the basis of sex, including gender identity. Gender-affirming care,
like all medical care, should follow clinical practice guidelines and
professional standards of care.\423\ Informed consent to any medical
treatment is both a legal and ethical standard, regardless of the type
of care, and serves as a basis for shared decision making.\424\ When
providing gender-affirming medical care for minors, informed consent
involves discussions among providers, minors, and parents or
guardians.\425\
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\422\ 42 U.S.C. 18114(3), (4).
\423\ See e.g., WPATH Standards, supra note 139; Wylie Hembree
et al., Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent
Persons: An Endocrine Society Clinical Practice Guideline, 102 J.
Clinical Endocrinology & Metabolism 3869 (2017), https://academic.oup.com/jcem/article/102/11/3869/4157558.
\424\ Am. Med. Ass'n, Informed Consent, https://www.ama-assn.org/delivering-care/ethics/informed-consent (last visited June
15, 2022).
\425\ Hilary Cass, The Cass Review, Independent Review of Gender
Identity Services for Children and Young People: Interim Report
(2022), https://cass.independent-review.uk/publications/interim-report/.
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We seek comment on this section, including whether it adequately
addresses the forms of discrimination faced by individuals on the basis
of sex (including pregnancy, sexual orientation, gender identity, and
sex characteristics) when seeking access to and participating in health
programs and activities; whether the proposed regulation text captures
the policies set forth in this preamble; what sex-based distinctions,
if any, should be permitted in the context of health programs and
activities; and the standards for permitting such distinctions that do
not result in more than de minimis harm.
We also invite comment on whether additional regulatory language
should be added to specifically address the circumstance in which a
provider offers a particular health treatment, service or procedure for
certain purposes, but refuses to offer that same treatment, service or
procedure for gender-transition or other gender-affirming care purposes
because they believe it would not be clinically appropriate.
Nondiscrimination in Health Insurance Coverage and Other Health-Related
Coverage (Sec. 92.207)
Proposed Sec. 92.207 prohibits discrimination on the basis of
race, color, national origin, sex, age, or disability in the provision
or administration of health insurance coverage and other health-related
coverage. This proposed section would apply to all covered entities
that provide or administer health insurance coverage or other health-
related coverage that receive Federal financial assistance, and the
Department in the administration of its health-related coverage
programs. This is consistent with the 2016 Rule, which similarly
prohibited discrimination in health-related insurance and other health-
related coverage under former Sec. 92.207, including in marketing
practices and benefit design. The 2020 Rule repealed former Sec.
92.207 in its entirety, stating that an additional or separate section
on health insurance was not necessary.\426\ Despite removing former
Sec. 92.207, the preamble to the 2020 Rule stated that OCR would
continue to investigate discrimination in health insurance, including
in benefit design.\427\
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\426\ 85 FR 37160, 37201 (June 19, 2020).
\427\ Id. at 37177, 37201.
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In rescinding former Sec. 92.207, the 2020 Rule creates a lack of
clarity for covered entities as to what constitutes prohibited
discrimination in health insurance and health-related coverage.\428\
This uncertainty creates confusion regarding what conduct is prohibited
and renders Section 1557 less effective at combatting discrimination in
health insurance and other health-related coverage, resulting in
greater risk for covered entities and less protection for people who
need health care and who are protected by Section 1557 against
discrimination.
---------------------------------------------------------------------------
\428\ See Valarie K. Blake, Health Care Civil Rights Under
Medicare for All, 72 Hastings L.J. 773, 800 (2021), https://repository.uchastings.edu/cgi/viewcontent.cgi?article=3925&context=hastings_law_journal (stating
the 2020 Rule ``eliminated all of the specific guidance on what
counts as insurance discrimination, leaving the issue to OCR and the
courts'').
---------------------------------------------------------------------------
The statutory text of Section 1557 demonstrates Congress' intent to
apply Section 1557 nondiscrimination requirements to health insurance
and other health-related coverage where an entity receives Federal
financial assistance and, therefore, the Department proposes to
reinstate specific provisions related to nondiscrimination in health
insurance and other health-related coverage in the Section 1557 rule.
Robust enforcement of such nondiscrimination requirements for health
insurance and other health-related coverage practices is critical to
ensure individuals' ability to receive the health services that they
need, unencumbered by discriminatory conduct. Such discriminatory
conduct
[[Page 47869]]
reduces both access to care and the quality of care received on the
basis of race, color, national origin, sex, age, or disability. The
Department's proposal to reinstate the provisions is consistent not
only with the ACA, but with the Administration's mission to enhance the
health and well-being of all Americans.\429\
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\429\ Mission Statement, U.S. Dep't of Health & Human Servs.,
https://www.hhs.gov/about/strategic-plan/introduction/#mission (last updated Mar. 28, 2022).
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E.O. 14009, ``Strengthening Medicaid and the Affordable Care Act,''
states that it is the Administration's policy to ``protect and
strengthen Medicaid and the ACA and to make high-quality health care
accessible and affordable for every American.'' \430\ Of particular
relevance to Section 1557, E.O. 14009 requires agencies to examine
policies or practices that may undermine protections for people with
pre-existing conditions under the ACA, may present ``unnecessary
barriers'' to individuals seeking access to Medicaid or ACA coverage,
and may reduce the affordability of coverage.\431\ Additionally, E.O.
14070, ``Continuing To Strengthen Americans' Access to Affordable,
Quality Health Coverage,'' states that agencies ``. . . shall review
agency actions to identify ways to continue to expand the availability
of affordable health coverage, to improve the quality of coverage, to
strengthen benefits, and to help more Americans enroll in quality
health coverage.'' \432\ By specifying that health insurance and other
health-related coverage offered through the Exchanges and Medicaid must
be provided in a nondiscriminatory manner, proposed Sec. 92.207 would
strengthen access to health care and prevent unnecessary barriers in
accessing coverage consistent with E.O. 14009 and E.O. 14070.
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\430\ 86 FR 7793 (Jan. 28, 2021) (revoking E.O. 13765,
``Minimizing the Economic Burden of the Patient Protection and
Affordable Care Act Pending Repeal,'' 82 FR 8351 (Jan. 20, 2017),
which was cited as a justification for the 2020 Rule).
\431\ Id. at 7794.
\432\ 87 FR 20689, 20690 (Apr. 8, 2022).
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As discussed previously, historically marginalized communities
disproportionally suffer from worse health outcomes and higher rates of
discrimination in accessing health care than other communities.\433\ By
addressing the prevention of discrimination in health insurance and
other health-related coverage, proposed Sec. 92.207 also aligns with
the Administration's goal of achieving health equity for these
populations.\434\ Adopting proposed Sec. 92.207, particularly
paragraphs (b)(3)-(5), would establish specific provisions to protect
gender-diverse individuals from discrimination in health insurance and
other health-related coverage.
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\433\ See discussion supra section II.D. (on advancing health
equity).
\434\ See, e.g., E.O. 13985, 86 FR 7009 (2021).
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Proposed paragraph (a) provides a general nondiscrimination
requirement, and proposed paragraph (b) provides specific examples of
prohibited actions.
Proposed paragraph (b)(1) specifies that covered entities are
prohibited from denying, cancelling, limiting, or refusing to issue or
renew health insurance coverage or other health-related coverage, or
denying or limiting coverage of a claim, or imposing additional cost
sharing or other limitations or restrictions on coverage, on the basis
of race, color, national origin, sex, age, or disability. This language
is identical to the 2016 Rule and would prohibit health insurance
issuers and other covered entities \435\ from taking discriminatory
actions related to coverage.
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\435\ A variety of entities may be considered covered entities
subject to proposed Sec. 92.207, including but not limited to
health insurance issuers, sponsors of group health plans, Medicare
Advantage organizations, Medicare Part D plan sponsors, Medicaid
managed care organizations, pharmacy benefit managers, third party
administrators (as part of a covered entity's operations when it
meets the criteria in paragraph (b) of the definition of ``health
program or activity'' in proposed Sec. 92.4), and the Department.
For simplicity, we simply refer to ``health insurance issuers'' or
``issuers'' throughout the preamble, but please note that other
covered entities may also be subject to the proposed section under
discussion.
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Proposed paragraph (b)(2) prohibits marketing practices or benefit
designs that discriminate on the basis of race, color, national origin,
sex, age, or disability. This is consistent with both the 2016 Rule,
which contained the same regulatory language, as well as the assurance
in the preamble of the 2020 Rule that OCR will continue to investigate
discrimination in health insurance or other health coverage benefit
design, despite the repeal of former Sec. 92.207.\436\ Reinstating
this provision will provide clarity and notice to covered entities and
the public that Section 1557 continues to prohibit discriminatory
marketing practices and benefit designs on the bases specified under
Section 1557. This provision is independent of other regulations that
separately prohibit discrimination in health insurance or other health-
related coverage.\437\ While these nondiscrimination requirements
complement each other, covered entities are required to independently
comply with all applicable regulations.
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\436\ See 85 FR 37177, 377201.
\437\ See, e.g., 42 CFR 422.100(f)(2)-(3), Sec. 422.110
(Medicare Advantage); 42 CFR 423.2262(a)(1)(iv) (Part D); 42 CFR
438.3(d), (f) (Medicaid); 42 CFR 600.405(d) (Basic Health Program);
45 CFR 147.104(e) (group and individual health insurance markets);
45 CFR 155.120(c) (Exchanges); 45 CFR 156.125(a)-(b) (essential
health benefits); 45 CFR 156.200(e), Sec. 156.225(b) (qualified
health plans).
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The terms ``benefit design'' and ``marketing practices'' encompass
an array of features. To avoid being overly prescriptive or
unintentionally inconsistent with other departmental regulations,\438\
the Department does not propose defining these terms in this rule and
intends to interpret them broadly. Examples of benefit design features
include, but are not limited to, coverage, exclusions, and limitations
of benefits; prescription drug formularies; cost sharing (including
copays, coinsurance, and deductibles); utilization management
techniques (such as step therapy and prior authorization); medical
management standards (including medical necessity standards); provider
network design; and reimbursement rates to providers and standards for
provider admission to participate in a network.
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\438\ Other departmental and Federal regulations governing
private health insurance and public health coverage refer to
``benefit design'' and ``marketing practices.'' See, e.g., 45 CFR
147.104(e), Sec. 156.20, Sec. 156.125(a) (health insurance
issuers); 45 CFR 156.110(d), Sec. 156.125(a), Sec. 156.200(b)(3),
Sec. 156.225(b) (qualified health plans); 45 CFR 156.110(d), Sec.
156.111(b)(2)(v) (essential health benefits benchmark plans); 42 CFR
422.100(f)(3) (Medicare Advantage); 42 CFR 422.2260-15 (Medicare
Part D marketing requirements); 42 CFR 423.882, Sec. 423.894(d)
(Medicare retiree prescription drug plans); 42 CFR 440.347(e)
(Medicaid benchmark plans); 42 CFR 600.405 (Basic Health Program);
29 CFR 2510.3-40(c)(1)(iv)(A) (employee welfare benefit plan under
Employee Retirement Income Security Act of 1974).
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Marketing practices would broadly include, for example, activities
designed to encourage individuals to participate or enroll in
particular health plans or certain types of plans, or to discourage
them from doing so, and activities that steer or attempt to steer
individuals towards or away from a particular plan or certain types of
plans.\439\ For example, covered entities that avoid advertising in
areas populated by a majority of people of color to reduce the
[[Page 47870]]
enrollment of people of color in their plans could violate this
provision.\440\
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\439\ For simplicity and for purposes of this preamble only, we
use the term ``health plan'' or ``plan'' interchangeably to refer
generally to health insurance coverage and other health coverage
that is subject to this proposed rule. As used in this preamble,
``health plan'' or ``plan'' may include health insurance coverage
offered in the group and individual markets, group health plans,
Medicare Advantage plans, Medicare Part D plans, and Medicaid plans
that are subject to this proposed rule. We do not intend ``health
plan'' or ``plan'' to be regulatory terms in this proposed
regulation or to replace any existing or proposed term in Federal
law.
\440\ See Sidney D. Watson, Section 1557 of the Affordable Care
Act: Civil Rights, Health Reform, Race, and Equity, 55 How. L.J.
855, 868 (2012), https://heinonline.org/HOL/LandingPage?handle=hein.journals/howlj55&div=33&id=&page=.
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By clarifying that health insurance and other health-related
coverage must not employ discriminatory benefit design or marketing
practices, proposed paragraph (b)(2) would further the ACA's goals of
expanding access to affordable and quality health care and would be
consistent with existing departmental regulations governing health
insurance and other health-related coverage that similarly prohibit
such discriminatory practices. The ACA prohibits the use of many
formerly standard health insurance industry practices in many types of
coverage that resulted in higher costs or denial of coverage or
benefits for individuals with disabilities and others, including
practices such as medical underwriting and premium rating \441\ and
pre-existing condition exclusions.\442\ Its prohibition of
discrimination in health-related coverage furthers the same goals.
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\441\ 42 U.S.C. 300gg (prohibiting discriminatory premium rates
by limiting rating factors to only include family size, geographic
rating area, age, and tobacco use); 300gg-1 (requiring guaranteed
availability of coverage to any individual or employer applying for
coverage); 300gg-2 (requiring guaranteed renewability of coverage at
the option of the plan sponsor or individual).
\442\ 42 U.S.C. 300gg-3.
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We acknowledge that covered entities have discretion in designing
their benefit packages, and we do not require entities to cover any
particular procedure or treatment. When assessing complaints alleging
discrimination in benefit design, OCR will evaluate on a case-by-case
basis whether a particular design feature or coverage requirement is
discriminatory. Where appropriate, OCR will determine if there is a
legitimate, nondiscriminatory justification for the particular benefit
design feature or coverage requirement. This justification cannot be
pretext for discrimination. We elaborate further about how OCR will
analyze claims of discrimination in benefit design later in this
section.\443\ As we articulate in that discussion,\444\ this rule is
not intended to prohibit covered entities from utilizing
nondiscriminatory medical management techniques.
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\443\ See discussion infra under this section on Benefit Design.
\444\ See discussion infra under this section on paragraph (c).
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Proposed paragraphs (b)(3) through (5) address benefit designs that
impermissibly limit coverage based on a person's sex at birth, gender
identity, or gender otherwise recorded. The Department believes it is
important to address discrimination faced by transgender individuals,
including nonbinary and gender diverse individuals, in accessing
coverage of health services.\445\ Discrimination against transgender
people in health insurance and other health-related coverage remains
pervasive, especially for individuals who experience intersectional
discrimination, such as individuals who experience both transphobia and
racism.\446\ As reported in a 2020 study of self-identified LGBTQ
adults, 38 percent of transgender respondents--and 52 percent of
transgender respondents of color--said that they had been denied
hormone therapy coverage by their health insurer, and 43 percent
reported being denied coverage for surgery for their transition.\447\
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\445\ As noted elsewhere in this preamble, although individuals
with a gender identity that differs from their sex assigned at birth
are commonly referred to as transgender, many individuals do not
identify as such. Instead, some individuals may identify as
nonbinary or gender diverse, meaning they do not identify with
traditional binary gender or a single gender. Within these
provisions, the term ``transgender'' is being used as an umbrella
term to encompass individuals with transgender, nonbinary, gender
diverse identities.
\446\ Patterson, supra note 123, at p. 299.
\447\ Gruberg, supra note 129, at p. 21; see also James, supra
note 130, at p. 10 (2016) (25% of respondents with insurance
reported experiencing insurance discrimination based on their gender
identity, including being denied gender specific services and care
not related to gender affirmation).
---------------------------------------------------------------------------
OCR believes the approach proposed in Sec. 92.207(b)(3) through
(5), which is similar to provisions in the 2016 Rule, will once again
prove vital in helping to address discrimination faced by individuals
whose sex assigned at birth is different from their gender identity in
accessing coverage of health services, including health services that
are medically necessary,\448\ and is consistent with the legal
principle that discrimination on the basis of sex includes
discrimination on the basis of gender identity.\449\ As discussed
regarding how the Department will evaluate claims of discrimination
under proposed Sec. 92.206(b), the Department will look for direct or
circumstantial evidence of discrimination when considering claims of
intentional discrimination. Direct evidence may come in the form of an
express classification (e.g., explicit conditions for the receipt of
benefits or services based on the sex of an individual) or statements
from decisionmakers that express discriminatory intent. In the absence
of such direct evidence, the Department would look for circumstantial
evidence, including by using the Arlington Heights factors or McDonnell
Douglas framework.
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\448\ The definition of medical necessity can vary. While the
term ``medical necessity'' is not explicitly defined by CMS statute
or regulation, Medicare provides coverage for items and services
that are ``reasonable and necessary for the diagnosis or treatment
of illness or injury or to improve the functioning of a malformed
body member.'' 42 U.S.C. 1395y(a)(1)(A). CMS further outlines
medical necessity requirements for specific services in its various
Medicare Policy Manuals. See, e.g., Ctrs. for Medicare & Medicaid
Servs., Medicare Program Integrity Manual, Chapter 6--Medicare
Contractor Medical Review Guidelines for Specific Services, Sec.
6.1.4--Medical Review Process, p. 7 (2020), https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c06.pdf
(stating ``[c]linical documentation that supports medical necessity
may be expected to include: physician orders for care and
treatments, medical diagnoses, rehabilitation diagnosis (as
appropriate), past medical history, progress notes that describe the
beneficiary's response to treatments and his/her physical/mental
status, lab and other test results, and other documentation
supporting the beneficiary's need for the skilled services being
provided in the SNF.''). CMS defines ``medically necessary'' in the
Summary of Benefits and Coverage (SBC) Template Uniform Glossary as
``[h]ealth care services or supplies needed to prevent, diagnose, or
treat an illness, injury, condition, disease, or its symptoms,
including habilitation, and that meet accepted standards of
medicine.'' Ctrs. for Medicare & Medicaid Servs., Glossary of Health
Coverage and Medical Terms, p. 3 (2020), https://www.cms.gov/CCIIO/Resources/Forms-Reports-and-Other-Resources/Downloads/Uniform-Glossary-01-2020.pdf. The American Medical Association defines
``medical necessity'' as ``[h]ealth care services or products that a
prudent physician would provide to a patient for the purpose of
preventing, diagnosing or treating an illness, injury, disease or
its symptoms in a manner that is: (a) in accordance with generally
accepted standards of medical practice; (b) clinically appropriate
in terms of type, frequency, extent, site, and duration; and (c) not
primarily for the economic benefit of the health plans and
purchasers or for the convenience of the patient, treating
physician, or other health care provider.'' Am. Med. Ass'n,
Definitions of ``Screening'' and ``Medical Necessity'' H-320.953
(2016), https://policysearch.ama-assn.org/policyfinder/detail/H-320.953?uri=%2FAMADoc%2FHOD.xml-0-2625.xml; see also WPATH
Standards, supra note 139. While this regulation and preamble
primarily use the term ``medical necessity,'' many covered entities
also consider the related concepts of ``medical appropriateness'' or
``clinical appropriateness'' in making decisions about care and
coverage, as can be seen in the definitions in this footnote. For
the purposes of this rule, any such decisions must be
nondiscriminatory, regardless of the label used.
\449\ Bostock v. Clayton Cty., 140 S. Ct. 1731 (2020).
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Proposed paragraph (b)(3) clarifies that it is prohibited
discrimination to deny or limit coverage, deny or limit coverage of a
claim, or impose additional cost sharing or other limitations or
restrictions on coverage to an individual based upon the individual's
sex at birth, gender identity, or gender otherwise recorded.\450\ The
2016 Rule provided a
[[Page 47871]]
more specific prohibition, which provided that to deny or limit
coverage, deny or limit coverage of a claim, or impose additional cost
sharing or other limitations or restrictions on any health service that
is ordinarily or exclusively available to persons of one sex when the
denial or limitation is due to the fact that the individual's sex
assigned at birth, gender identity, or gender otherwise recorded by the
covered entity, is different from the one to which such services are
ordinarily or exclusively available was prohibited sex discrimination.
Such discrimination is similarly prohibited under this provision.
---------------------------------------------------------------------------
\450\ Under the general nondiscrimination requirement in
proposed Sec. 92.207(a), a covered entity would be barred from
denying coverage of any claim (not just for sex-specific services)
on the basis that the enrollee's sex assigned at birth is different
than their gender identity.
---------------------------------------------------------------------------
Although covered health plans routinely cover sex-specific
preventive care services (e.g., prostate and cervical cancer
screenings) for cisgender individuals, some transgender individuals,
due to their gender identity or because they are not enrolled in their
health plan consistent with their sex assigned at birth, are denied
coverage parity for the same preventive health services.\451\ For
example, under proposed Sec. 92.207(b)(3), a health insurance issuer
may not deny coverage for a transgender man who requires a mammogram
screening, based on the fact that he is enrolled in the health plan as
a man.\452\ Nor could they deny him coverage of a uterine biopsy to
identify potential uterine cancer because he is enrolled in the health
plan as a man. Distinct from Section 1557, we remind covered entities
that section 2713 of the Public Health Service Act (``PHS Act'') and
its implementing regulations generally require coverage for certain
recommended preventive health services without imposing cost-sharing
requirements.\453\
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\451\ Providers and issuers frequently formulate incorrect
assumptions about transgender and gender non-conforming individual's
bodies when assessing medical necessity for sex-specific preventive
care. For example, cervical cancer risks for transgender men are
sometimes erroneously assumed by providers to be lower than for
cisgender women. Only 64% of respondents who retained a uterus were
told by their providers to get screened for cervical cancer. See
Mandi L. Pratt-Chapman & Adam R. Ward, Provider Recommendations Are
Associated with Cancer Screening of Transgender and Gender-
Nonconforming People: A Cross-Sectional Urban Survey, 5 Transgender
Health 80, 83 (2020), https://www.liebertpub.com/doi/10.1089/trgh.2019.0083.
\452\ See also FAQs about Affordable Care Act Implementation
(Part XXVI), Q5 (May 11, 2015) (stating ``[w]hether a sex-specific
recommended preventive service that is required to be covered
without cost sharing under PHS Act section 2713 and its implementing
regulations is medically appropriate for a particular individual is
determined by the individual's attending provider. Where an
attending provider determines that a recommended preventive service
is medically appropriate for the individual--such as, for example,
providing a mammogram or pap smear for a transgender man who has
residual breast tissue or an intact cervix--and the individual
otherwise satisfies the criteria in the relevant recommendation or
guideline as well as all other applicable coverage requirements, the
plan or issuer must provide coverage for the recommended preventive
service, without cost sharing, regardless of sex assigned at birth,
gender identity, or gender of the individual otherwise recorded by
the plan or issuer''), available at https://www.cms.gov/cciio/resources/fact-sheets-and-faqs/downloads/aca_implementation_faqs26.pdf and https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-xxvi.pdf.
\453\ 45 CFR 147.130; 26 CFR 54.9815-2713; 29 CFR 2590.715-2713.
---------------------------------------------------------------------------
We clarify that Section 1557 does not prohibit a covered entity
from inquiring about an individual's relevant medical history and
physical traits when necessary to determine the medical necessity of a
health service for that individual. For example, in the same way a
medical professional would not be prohibited from treating a pregnant
transgender man for pregnancy,\454\ a health insurance issuer
(including its third party administrator activities, if applicable) may
confirm that treatment related to pregnancy is medically necessary for
an enrollee whose recorded sex is male.
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\454\ See discussion supra proposed Sec. 92.206(b)(3), (c).
---------------------------------------------------------------------------
We seek comment on this provision, including whether it
sufficiently addresses the challenges transgender and gender
nonconforming individuals are experiencing when seeking to access to
medically necessary care due to a discordance between their sex
assigned at birth and their sex as recorded by their issuer.
The Department, in paragraph (b)(4), proposes to prohibit a covered
entity from having or implementing a categorical coverage exclusion or
limitation for all health services related to gender transition or
other gender-affirming care.\455\ This is consistent with the 2016 Rule
at former Sec. 92.207(b)(4), modified to include gender-affirming
care. Some health plans continue to have a categorical ban on all
gender-affirming care for transgender individuals as not medically
indicated and as improper care to treat gender dysphoria, regardless of
whether such care has been prescribed by a health care professional and
despite widespread professional consensus to the contrary.\456\
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\455\ As noted in the discussion of Sec. 92.206 above, this
preamble uses the terms ``gender transition'' and ``gender
affirmation'' interchangeably in discussing the range of care that
transgender individuals (including those who identify using other
terms, for example, nonbinary or gender nonconforming) may seek to
treat gender dysphoria and support gender transition or affirmation.
Because insurance coverage provisions and medical-necessity
determinations more often use the term gender transition, within
these provisions, the term gender affirmation encompasses gender
transition, that is the terminology used in the text of the
regulation. The use of the term ``gender transition'' in the
regulation, however, is not intended to convey a narrower meaning
than the term ``gender affirmation.''
\456\ See Boyden v. Conlin, 341 F. Supp. 3d 979, 987 (W.D. Wis.
2018) (noting that the American Medical Association, the American
Psychiatric Association, the American Psychological Association, the
American Counseling Association, the American Psychoanalytic
Association, and the World Professional Association of Transgender
Health, all recognize the medical necessity of transition related
care for transgender people with gender dysphoria); see also Flack
v. Wisconsin Dep't of Health Servs., 395 F. Supp. 3d 1001, 1005
(W.D. Wis. 2019) (``For appropriate candidates, however, major
medical organizations, including the American Medical Association,
Endocrine Society, and American Psychiatric Association view gender-
confirming surgeries as medically accepted, safe, and effective
treatments for severe gender dysphoria.'').
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Such categorical exclusions in covered plans both facially deny
transgender individuals coverage access based on their gender identity
and result in more than de minimis harm to the individuals; therefore
they are prohibited discrimination on the basis of sex.\457\ A covered
entity's denial of coverage solely on the basis of one's sex assigned
at birth--i.e., if the individual was assigned a different sex at
birth, such care coverage would not be denied--constitutes disparate
treatment and is prohibited under this proposed rule because
transgender individuals are the only individuals who seek transition-
related care.\458\ Additionally, a recent district court opinion found
that ``it is impossible to determine whether a particular treatment is
connected to'' gender affirming care without comparing [the person's]
``sex before the treatment to how it might be impacted by the
treatment.'' \459\
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\457\ See e.g., Flack, 395 F. Supp. at 1001 (striking down
Wisconsin Medicaid exclusion under Section 1557, Availability and
Comparability Provisions of the Medicaid Act, and Equal Protection
Clause of the U.S. Constitution); Cruz v. Zucker, 195 F. Supp. 3d
554, 571 (S.D.N.Y. 2016), on reconsideration, 218 F. Supp. 3d 246
(S.D.N.Y. 2016), appeal withdrawn (Dec. 30, 2016) (finding that a
categorical ban on medically necessary treatments for a specific
diagnosis, gender dysphoria, violates the Federal Medicaid Act's
Availability Provision).
\458\ See U.S. Dep't of Justice, Brief for the United States as
Amicus Curiae in Support of Plaintiffs-Appellees, Brandt v.
Rutledge, No. 21-2875, 11 (8th Cir. Aug. 23, 2021) (``Only persons
who are transgender would seek these ``gender transition
procedures,'' because only their gender identity differs from their
``biological sex'' (as defined by the Act).'').
\459\ Kadel v. Folwell, No. 1:10-cv-00272, 2022 WL 2106270, at
*19 (M.D.N.C. June 10, 2022).
---------------------------------------------------------------------------
Nonetheless, some health plans still have broad exclusions of
coverage for care related to gender dysphoria or associated with gender
affirmation.\460\
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\460\ See Out2Enroll, Summary of Findings: 2021 Marketplace Plan
Compliance with Section 1557, p. 1 (2021), https://out2enroll.org/wp-content/uploads/2020/11/Report-on-Trans-Exclusions-in-2021-Marketplace-Plans.pdf (listing Bright Health, Ala., Ariz., Ill.,
N.C., Neb., Okla., S.C., Tenn.; United Healthcare, Ariz., Okla.,
Tenn.; Alliant, Ga.; Mercy Care, Ill. as offering plans that include
categorical exclusions for all transition-related care). Until 2020,
the percentage of issuers that affirmatively stated that some or all
gender-affirming care for transgender individuals is covered had
increased each year. There continues to be a presumption among some
issuers, however, that except under narrow circumstances, such care
is not medically necessary and therefore not covered. Id.
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[[Page 47872]]
The Department proposes in paragraph (b)(5) to ensure that a
covered entity does not impose discriminatory limits on coverage for
specific health services related to gender transition or other gender
affirming care, which would generally be the case if such limits are
not applied when those same health services are not related to gender
transition. The limits that could constitute discriminatory conduct
prohibited by this paragraph include denying or limiting coverage,
denying or limiting a claim for coverage, imposing additional cost
sharing, or other limitations or restrictions on coverage on the basis
of gender identity. For example, a health plan that excludes ``coverage
for surgery, such as a vaginoplasty and mammoplasty'' for any enrollee
whose sex assigned at birth is male ``while providing coverage for such
medically necessary surgery'' for enrollees whose sex assigned at birth
is female ``is discriminatory on its face.'' \461\ Exclusions that
limit care related to one class of gender transition or other gender-
affirming care may also violate this provision.\462\
---------------------------------------------------------------------------
\461\ Fletcher v. Alaska, 443 F. Supp. 3d 1024, 1031 (D. Alaska
2020) (Title VII); see also Kadel, No. 1:19-cv-00272, 2022 WL
2106270, at *28-*29 (Title VII).
\462\ See, e.g., Conn. Comm'n on Human Rights & Opportunities,
Declaratory Ruling on Petition Regarding Health Insurers'
Categorization of Certain Gender-Confirming Procedures as Cosmetic
(Apr. 17, 2020), https://www.glad.org/wp-content/uploads/2020/04/Dec-Rule_04152020.pdf (discussing how depending on the policy or
plan, the categorical exclusion of certain procedures for gender
dysphoria discriminates on the basis of sex by denying equal access
to certain medical procedures based on an individual's assigned sex.
As such, a blanket policy exclusion for gender transition and
related services is prohibited.). See also Challenging Insurance
Exclusions for Gender Affirming Medical Care, GLBTQ Legal Advocates
& Defenders, https://www.glad.org/cases/challenging-insurance-exclusions-for-gender-affirming-medical-care (last updated April 23,
2020).
---------------------------------------------------------------------------
The proposed paragraphs (b)(3) through (5) do not: require covered
entities to cover specific procedures or treatments for gender
transition or other gender-affirming care that they do not otherwise
cover under the plan.
In proposed paragraph (b)(6), the Department proposes an
integration provision that prohibits covered entities from having or
implementing a benefit design that does not provide or administer
health insurance coverage or other health-related coverage in the most
integrated setting appropriate to the needs of qualified individuals
with disabilities.
The Department's existing Section 504 regulation includes an
integration provision at 45 CFR 84.4(b)(2), which would be incorporated
into Section 1557 at proposed Sec. 92.101(b)(1). Section 504's
integration provision provides that covered entities must provide
services and programs in the most integrated setting appropriate to the
needs of the qualified individual with a disability (referred to as the
``integration mandate''). The most integrated setting appropriate to
the needs of an individual with a disability means a setting that
enables individuals with disabilities to interact with individuals
without disabilities to the fullest extent possible.\463\ In 1999, the
Supreme Court held in Olmstead v. L.C.\464\ that the ADA's integration
mandate prohibits the unjustified segregation of individuals with
disabilities. Section 504's integration mandate creates the same set of
obligations for entities that receive Federal financial assistance. In
addition, health programs and activities must make reasonable
modifications to policies, practices, or procedures when necessary to
avoid discrimination on the basis of disability, unless the covered
entity can demonstrate that making the modifications would
fundamentally alter the nature of the service, program, or
activity.\465\
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\463\ 28 CFR pt. 35, app. B (2011) (addressing Sec. 35.130).
\464\ Olmstead v. L.C., 527 U.S. 581 (1999).
\465\ 28 CFR 35.130(b)(7)(i); 45 CFR 92.105; see also Olmstead,
527 U.S. at 603-07.
---------------------------------------------------------------------------
Covered entities providing or administering health insurance or
other health-related coverage are subject to the integration
requirements under Section 504. Despite these obligations, covered
entities may not be taking these requirements into account in their
health-related coverage benefit design.\466\ For example, literature
shows that variation in benefit design, including reimbursement rates,
impact whether individuals with disabilities exiting hospitals enter
institutional, congregate, or otherwise segregated settings for post-
acute care services, with payment practices and provider network design
playing a greater role than clinical characteristics in some
instances.\467\
---------------------------------------------------------------------------
\466\ See Letter from the Bazelon Center for Mental Health Law
to Robinsue Frohboese, Acting Dir., Office for Civil Rights, U.S.
Dep't of Health & Human Servs. (June 7, 2021) (discussing how
benefit design decisions can result in needless segregation of
people with disabilities). The letter will be attached to the docket
of this proposed rule as a supplemental material at
federalregister.gov.
\467\ Medicare Advantage and commercial health plan benefit
designs that impose beneficiary cost-sharing, referral requirements
or prior authorization requirements can restrict access to home
health services. See, e.g., Lacey Loomer et al., Comparing Receipt
of Prescribed Post-Acute Home Health Care Between Medicare Advantage
and Traditional Medicare Beneficiaries: An Observational Study, 36
J. Gen. Intern. Med. 2323 (2020), https://link.springer.com/content/pdf/10.1007/s11606-020-06282-3.pdf (finding that receipt of post-
acute home health care was lower for Medicare Advantage enrollees
compared with traditional Medicare enrollees, and that among
Medicare Advantage enrollees, HMO plans with home health utilization
restrictions (i.e., cost sharing, pre-authorization, referral
requirements) were less likely to receive prescribed home health);
Laura Skopec et al., Home Health Use in Medicare Advantage Compared
to Use in Traditional Medicare, 39 Health Affairs 1072 (2019),
https://www.healthaffairs.org/doi/10.1377/hlthaff.2019.01091
(finding Medicare Advantage enrollees were less likely to use home
health care than traditional Medicare enrollees were and had shorter
average home health spells, and suggesting that these differences in
use and length of spell may be related to differences in how
Medicare Advantage plans manage and pay for home health care); Scott
E. Regenbogen et al., Spending on Postacute Care After
Hospitalization in Commercial Insurance and Medicare Around Age
Sixty-five, 38 Health Affairs 1505 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7795720/pdf/nihms-1659826.pdf
(finding that the benefit design practices of commercial insurers
result in substantially less access to home health services for
post-acute care than that which is available in fee-for-service
Medicare). Such reductions in home health use do not necessarily
violate the integration mandate if issuers simply reduce unnecessary
service-provision without increasing risk of institutionalization
and apply standard medical management techniques in a
nondiscriminatory fashion as permitted under Section 1557 (proposed
Sec. 92.207(c)). However, a benefit design restricting access to
home health services may raise concerns under the integration
mandate if it leads to a serious risk of unjustified or unnecessary
institutionalization of people with disabilities. Benefit design can
also reduce the risk of institutionalization, including long-term
institutionalization. See, e.g., Amit Kumar et al., Comparing Post-
Acute Rehabilitation Use, Length of Stay, and Outcomes Experienced
by Medicare Fee-for-Service and Medicare Advantage Beneficiaries
with Hip Fracture in the United States: A Secondary Analysis of
Administrative Data, 15 PLoS Med., June 6, 2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019094/pdf/pmed.1002592.pdf
(finding that benefit design and care management practices adopted
by Medicare Advantage plans resulted in a lower risk of long-term
institutionalization within a nursing home and a higher rate of
successful discharge to the community relative to those used in fee-
for-service Medicare).
---------------------------------------------------------------------------
OCR's intent in articulating this provision is to clarify that a
benefit design that results in the unjustified segregation or
institutionalization of qualified individuals with disabilities or that
place such individuals at serious risk of unjustified
institutionalization or segregation is prohibited disability
discrimination.
For instance, benefit designs raising integration concerns may
include those that: limit or deny access to services in
[[Page 47873]]
the most integrated setting while making comparable services available
in segregated or institutional settings; place additional terms and
conditions on the receipt of certain benefits in integrated settings
that are not in place within segregated or institutional settings;
impose more restrictive rules or requirements for coverage for services
in community-based settings than those applied to coverage for services
in segregated or institutional settings; or set better reimbursement
rates for a service or item for individuals in segregated settings than
for individuals in community settings.\468\ For example, an issuer
covering a service or benefit (such as personal care or durable medical
equipment) for individuals in institutional settings, but not covering
the same service or benefit for individuals living in their own homes
or in other community settings would violate this provision if the
difference in coverage resulted in the unnecessary segregation of
individuals with disabilities, or a serious risk of such segregation,
unless it could show that modifications (to the coverage rule or
policy) would fundamentally alter the nature of the service, program,
or activity. We note that a state Medicaid program would generally not
be required to provide a new benefit, because that would fundamentally
alter the nature of the program. However, to the extent that a benefit,
including an optional benefit, is already provided as part of the
state's program, it must be offered in a manner that does not
incentivize institutional services over community services.\469\
---------------------------------------------------------------------------
\468\ See Letter from the Bazelon Ctr. for Mental Health Law,
supra note 466 (discussing how benefit design decisions can result
in needless segregation of people with disabilities). The letter
will be attached to the docket of this proposed rule as a
supplemental material at federalregister.gov.
\469\ See, e.g., Radaszewski ex rel Radaszewski v. Maram, 383
F.3d 599, 611 (7th Cir. 2004) (``Although a state is not obliged to
create entirely new services or to otherwise alter the substance of
the care that it provides to Medicaid recipients . . . the
integration mandate may well require the State to make reasonable
modifications to the form of existing services in order to adapt
them to community-integrated settings.'')
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This provision will also be interpreted to apply both to
circumstances where individuals with disabilities are unnecessarily
segregated or institutionalized as a result of benefit design features,
and circumstances where the benefit design places individuals with
disabilities at serious risk of placement within an institution,
congregate care setting, or other segregated settings through the
coverage of or payment for services offered or provided in integrated
settings relative to segregated ones, or through funding or service
implementation practices within a benefit design set or administered by
a covered entity that result in such a risk.\470\ For example, a
Medicare Advantage plan that requires prior authorization or step
therapy to receive a medication in the community, but not in a skilled
nursing facility, would be in violation of this provision if the
discrepancy resulted in unnecessary segregation or a serious risk of
unnecessary segregation and the distinction was not clinically
appropriate. Similarly, if the plan relied on a pharmacy benefit
manager (PBM) to administer prescription drug benefits, and the PBM
employed utilization management techniques in the community that
created greater barriers to accessing medication than in an
institutional setting, the PBM may be in violation of this provision if
the PBM is subject to this part.
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\470\ U.S. Dep't of Justice, Civil Rights Div., Statement of the
Department of Justice on Enforcement of the Integration Mandate of
Title II of the Americans with Disabilities Act and Olmstead v. L.C.
(June 22, 2011), https://www.ada.gov/olmstead/q&a_olmstead.htm. See
also Fisher v. Oklahoma Health Care Authority, 355 F.3d 1175 (10th
Cir. 2003) (finding that it violates the integration mandate to
restrict the number of prescription medications available to
individuals enrolled in Medicaid home and community-based services
to five per month while not applying such a cap to individuals in
institutional settings); see also Pashby v. Delia, 709 F.3d 307 (4th
Cir. 2021).
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This provision encompasses both the direct design of a benefit
offered by a covered entity and indirect mechanisms that affect the
implementation of a benefit design within the covered entity's control,
such as utilization management practices, provider reimbursement,
contracting out to third party-contractors such as PBMs, and quality
measurement and incentive systems. Covered entities designing contracts
with managed care organizations, PBMs, or other third-party entities
taking on financial risk for the delivery of health services should
carefully scrutinize their capitation, reimbursement, quality
measurement, and incentive structures to ensure that they do not result
in the unjustified segregation of individuals with disabilities or
place individuals with disabilities at serious risk of unjustified
segregation.
OCR seeks comment on the scope and nature of the benefit design
features that result in unjustified segregation or institutionalization
of qualified individuals with disabilities or place such individuals at
serious risk of unjustified institutionalization or segregation. We are
interested in feedback on the application of the integration mandate to
a wide variety of health services and are particularly interested in
comments on the application of the integration mandate to coverage of
post-acute services, mental health services, and other services
commonly provided by non-state payers (i.e., health insurance issuers,
self-insured group health plans, and other payers). We are also
interested in feedback on the application of the integration mandate to
the Medicaid program and its statutory framework at Title XIX of the
Social Security Act. Specifically, we request input on how state
Medicaid agencies are able to achieve compliance with the integration
mandate through benefit design, such as through reimbursement, service
scope, and service authorization that do not incentivize institutional
services over community services. In addition, we request input on the
amount of time needed to reach compliance with needed benefit design
modifications.
Proposed paragraph (c) states that nothing in this section requires
the coverage of any health service where the covered entity has a
legitimate, nondiscriminatory reason for determining that such health
service fails to meet applicable coverage requirements, such as medical
necessity requirements, in an individual case.
Covered entities may employ reasonable medical management
techniques, including medical necessity standards,\471\ for determining
coverage of a particular treatment based on whether it is medically
appropriate under current generally accepted standards of care for an
individual or whether the treatment is experimental or cosmetic, as
long as the medical management standards are not discriminatory and are
not otherwise prohibited under other applicable Federal and state law.
When developed and used appropriately in a nondiscriminatory manner,
medical necessity guidelines prevent unnecessary costs to covered
entities and protect the safety of enrollees by ensuring that the
requested treatment is safe and clinically appropriate for the
particular enrollee. This determination involves a medical review of
the patient's condition and the clinical appropriateness of the
requested treatment in accordance with the covered entity's medical
necessity guidelines. Such guidelines should be
[[Page 47874]]
applied in a neutral manner and could raise concerns under this
proposed rule if the guidelines establish more restrictive requirements
for certain diseases or conditions without justification, for example,
if the guidelines require a separate, more stringent review process
only for mental health services.\472\
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\471\ See supra note 448 discussing definitions of medical
necessity. See also 45 CFR 156.125(c) (CMS regulation prohibiting
discrimination in essential health benefits stating that ``nothing
in this section shall be construed to prevent an issuer from
appropriately utilizing reasonable medical management techniques'').
\472\ We note this practice may also violate the rules regarding
non-quantitative treatment limitations applicable to group health
plans and health insurance issuers under the Paul Wellstone and Pete
Domenici Mental Health Parity and Addiction Equity Act of 2008
(MHPAEA), Public Law 110-343, as amended, which is distinct from
Section 1557 and not enforced by OCR. See 42 U.S.C. 300gg-26 (HHS);
29 U.S.C. 1185a (Department of Labor); 26 U.S.C. 9812 (Department of
Treasury), and implementing regulations at 45 CFR 146.136, 29 CFR
2590.712, and 26 CFR 54.9812-1, respectively; see also U.S. Dep't of
Labor, U.S. Dep't of Health & Human Servs., U.S. Dep't of the
Treasury, 2022 MHPAEA Report To Congress: Realizing Parity, Reducing
Stigma, and Raising Awareness: Increasing Access to Mental Health
and Substance Use Disorder Coverage (2022), https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/report-to-congress-2022-realizing-parity-reducing-stigma-and-raising-awareness.pdf; U.S. Dep't of Labor, Self-Compliance tool for
the Mental Health Parity and Addiction Equity Act (MHPAEA), p. 38
(2020), https://www.dol.gov/sites/dolgov/files/EBSA/laws-and-regulations/laws/mental-health-parity/self-compliance-tool.pdf.
---------------------------------------------------------------------------
When OCR receives a complaint alleging that a denial of coverage
was based upon prohibited discrimination rather than on a
nondiscriminatory assessment of medical necessity, consistent with
longstanding OCR practice, OCR will not conduct a general review of the
medical judgment behind the denial for a specific individual. Rather,
OCR's review will focus on the narrow question of whether the rationale
for the denial was tainted by impermissible discriminatory
considerations. Thus, OCR may require a covered entity to provide its
medical necessity standards or guidelines; the clinical, evidence-based
criteria or guidelines \473\ relied upon to make the medical necessity
determination; and the medical substantiation for the medical necessity
determination.
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\473\ See Patient Protection and Affordable Care Act; HHS Notice
of Benefit and Payment Parameters for 2023, 87 FR 27208, 27296-300
(May 6, 2022) (discussing newly promulgated 45 CFR 156.125(a), which
states ``[a] non-discriminatory benefit design that provides
[essential health benefits] is one that is clinically-based'').
---------------------------------------------------------------------------
Claims of medical necessity that are not based upon genuine medical
judgments will be considered evidence of pretext for discrimination.
For example, issuers have historically excluded services related to
gender-affirming care for transgender people as experimental or
cosmetic (and therefore not medically necessary).\474\ Characterizing
this care as experimental or cosmetic would be considered evidence of
pretext because this characterization is not based on current standards
of medical care.\475\ Such exclusions are a form of disparate treatment
discrimination, as they distinguish between care that is covered and
care that is not solely by whether such care is provided as gender-
affirming care for transgender people. Thus, categorical exclusions for
gender-affirming care for transgender people that provide the basis for
the exclusion as ``experimental'' would result in prohibited
discrimination on the basis of sex. This is not to say that issuers
must cover all services related to gender-affirming care for
transgender individuals--or all medically necessary services generally.
Issuers retain flexibility in designing their benefit packages, and
this proposed rule would not require issuers to cover any particular
benefit or to cover all medically necessary services. It does require,
however, that issuers apply standards in a consistent, neutral,
nondiscriminatory manner that does not limit or deny services to
individuals based on a protected basis.
---------------------------------------------------------------------------
\474\ See discussion supra under this section on paragraphs
(b)(3) through (4).
\475\ Id.
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Proposed paragraph (c) also would not prohibit a covered entity
from engaging in utilization management techniques applied in a
neutral, nondiscriminatory manner. Utilization management techniques
include prior authorization,\476\ step therapy (or ``fail-
first''),\477\ and durational or quantity limits.\478\ Utilization
management controls, designed to control costs and ensure the
clinically appropriate use of services,\479\ are standard industry
practices \480\ that are permitted under Section 1557 as long as they
are applied in a neutral, nondiscriminatory manner and are not
otherwise prohibited under other applicable Federal and state law.\481\
Excessive use or administration of utilization management tools that
target a particular condition that could be considered a disability or
other prohibited basis could violate Section 1557.\482\ For example,
prescription drug formularies that place utilization management
controls on most or all drugs that treat a particular condition
regardless of their costs without placing similar utilization
management controls on most or all drugs used to treat other conditions
may be discriminatory under this section. Similarly, benefit designs
that place utilization management controls on most or all services that
treat a particular disease or condition but not others may raise
concerns of discrimination. Where there is an alleged discriminatory
practice or action, the covered entity would be expected to provide a
legitimate, nondiscriminatory reason, based on clinical evidence, for
the practice.
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\476\ Medicare defines ``prior authorization'' as ``the process
through which a request for provisional affirmation of coverage is
submitted to CMS or its contractors for review before the service is
provided to the beneficiary and before the claim is submitted for
processing.'' 42 CFR 419.81 (Medicare definition of prior
authorization for hospital outpatient department services). See also
Ctrs. for Medicare & Medicaid Servs., Prior Authorization Process
for Certain Hospital Outpatient Department (OPD) Services Frequently
Asked Questions (FAQs), Q1 (Dec. 27, 2021), https://www.cms.gov/files/document/opd-frequently-asked-questions.pdf.
\477\ Medicare defines ``step therapy'' for the Medicare
Advantage Program as a ``utilization management policy for coverage
of drugs that begins medication for a medical condition with the
most preferred or cost effective drug therapy and progresses to
other drug therapies if medically necessary.'' 42 CFR 422.2.
\478\ Durational or quantity limits place limits on the
frequency or number of benefits to be provided, such as limiting
therapy visits to once per week or limiting prescription drug
coverage to a 30-day supply of a medication.
\479\ See, e.g., Ctrs. for Medicare & Medicaid Servs., Prior
Authorization Process for Certain Hospital Outpatient Department
(OPD) Services Frequently Asked Questions (FAQs), Q1 (Dec. 27,
2021), https://www.cms.gov/files/document/opd-frequently-asked-questions.pdf (explaining prior authorization ``ensures that
Medicare beneficiaries continue to receive medically necessary care
while protecting the Medicare Trust Funds from unnecessary increases
in the volume of covered services and improper payments'' and
``helps to make sure that applicable coverage, payment, and coding
requirements are met before services are rendered while ensuring
access to and quality of care'').
\480\ See generally 42 U.S.C. 18120(1) (stating
``[n]otwithstanding any other provision in the [ACA], nothing in
such Act (or an amendment made by such Act) shall be construed to
(1) prohibit (or authorize the Secretary of Health and Human
Services to promulgate regulations that prohibit) a group health
plan or health insurance issuer from carrying out utilization
management techniques that are commonly used as of March 23,
2010'').
\481\ We note that, similar to medical necessity, discussed
previously, these practices would generally be subject to the rules
regarding non-quantitative treatment limitations applicable to group
health plans and health insurance issuers, with respect to medical/
surgical benefits and mental health and substance use disorder
benefits, under MHPAEA, see supra note 472.
\482\ See generally Stacey L. Worthy et al., Now or Never: The
Urgent Need for Action Against Unfair Coverage Denials for Quality
Health Care, 48 Loy. U. Chi. L.J. 1041 (2017), https://lawecommons.luc.edu/luclj/vol48/iss4/8/.
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Finally, the Department proposes Sec. 92.207(d) to explain that
the enumeration of specific forms of discrimination in paragraph (b)
does not limit the general applicability of the prohibition in
paragraph (a) of this section.
Benefit Design
As discussed when addressing the requirements of proposed paragraph
(b), OCR will apply basic nondiscrimination
[[Page 47875]]
principles to the facts of the particular plan or coverage when
analyzing allegations of discrimination under this section to determine
if the challenged action is unlawful. Due to the fact-intensive nature
of the analysis necessary to determine whether a particular benefit
design is discriminatory under this section, we decline to include
examples of per se discriminatory benefit design features in the
proposed rule (other than categorical exclusions of all health services
related to gender transition under proposed paragraph (b)(4), which, as
discussed above, impermissibly single out an entire category of
services based on an individual's gender identity).\483\ However, we
provide additional discussion here to demonstrate how OCR will approach
investigations related to allegedly discriminatory benefit design.
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\483\ For examples of presumptively discriminatory benefit
designs under CMS' essential health benefits nondiscrimination
regulations applicable to non-grandfathered health insurance
coverage in the individual and small group markets, see Patient
Protection and Affordable Care Act; HHS Notice of Benefit and
Payment Parameters for 2023, 87 FR 27208, 27301-05 (May 6, 2022)
(providing the following illustrative examples of presumptively
discriminatory practices under CMS' essential health benefits
nondiscrimination regulations: (1) limitation on hearing aid
coverage based on age; (2) autism spectrum disorder coverage
limitations based on age; (3) age limits for infertility treatment
coverage when treatment is clinically effective for the age group;
(4) limitation on foot care coverage based on diagnosis (whether
diabetes or another underlying medical condition); and (5) access to
prescription drugs for chronic health conditions (adverse tiering)).
We note these regulations are enforced by CMS and are distinct from
Section 1557 and other civil rights laws enforced by OCR.
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Consistent with general principles in civil rights law, covered
entities will have the opportunity to articulate a legitimate,
nondiscriminatory justification for an alleged discriminatory action or
practice. OCR will scrutinize the justification to ensure it is not a
pretext for discrimination. When articulating a justification for a
challenged action or practice that relies upon medical standards or
guidelines, covered entities should be mindful that such standards and
guidelines may be subject to additional scrutiny if they are not based
on clinical, evidence-based criteria or guidelines.
As discussed in detail later in this section,\484\ we propose to
apply this part to all the operations of a covered entity that is
principally engaged in the provision or administration of health
programs or activities as described in paragraph (a) of the proposed
definition of ``health program or activity,'' including a health
insurance issuer's excepted benefits and short-term limited duration
insurance products. Given the unique nature of these products, which
are generally exempt from complying with any of the ACA's market
reforms, we provide further analysis on how OCR proposes to investigate
potential claims of discrimination challenging benefit design features
in these products. OCR will consider the nature, scope, and contours of
the specific plan at issue, and will evaluate on a case-by-case basis
an alleged discriminatory design feature in light of the entity's
stated coverage parameters.\485\ Further, as discussed throughout this
section, covered entities have the opportunity to articulate a
legitimate, nondiscriminatory basis for their challenged action or
practice.
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\484\ See discussion infra under this section on Scope of
Application and Application to Excepted Benefits and Short-Term
Limited Duration Insurance.
\485\ Cf. Easley by Easley v. Snider, 36 F.3d 297, 301-05 (3d
Cir. 1994) (examining the ``essential nature of the program'' as
intended by the state when determining that a state's Attendant Care
Program did not discriminate against individuals with mental
disabilities under the ADA by excluding adults with disabilities who
were not mentally alert).
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Scope of Application and Application to Excepted Benefits and Short-
Term Limited Duration Insurance
Proposed Sec. 92.207 applies to all the operations of covered
entities that provide or administer health insurance coverage or other
health-related coverage, including health programs and activities that
receive Federal financial assistance, and the Department in the
administration of its health-related coverage programs, but would not
apply to employers generally or in their provision of employee health
benefits per proposed Sec. 92.2(b). Examples of recipients that
provide or administer health insurance coverage or other health-related
coverage include health insurance issuers, Medicare Advantage
organizations, Medicare Part D plan sponsors, and Medicaid managed care
organizations.
Per paragraph (b) of the proposed definition of ``health program or
activity'' under proposed Sec. 92.4, we propose to apply this part to
all the operations of any entity principally engaged in the provision
or administration of health programs or activities described in
paragraph (a) of the proposed definition of ``health program or
activity,'' including a health insurance issuer. Thus, this proposed
rule applies to all of a covered health insurance issuer's health
programs and activities in the individual or group health insurance
markets, including its offer of products through or outside of an
Exchange. For example, an issuer participating in the Exchange and
thereby receiving Federal financial assistance would be covered by the
rule for its qualified health plans (QHPs) offered on the Exchange, as
well as for its health plans offered outside the Exchange, including,
for example, large group market plans,\486\ grandfathered plans,\487\
grandmothered plans,\488\ excepted benefits,\489\ and short-term
limited duration insurance,\490\ as well as for its operations related
to acting as a third party administrator for a self-insured group
health plan.
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\486\ 42 U.S.C. 300gg-91(2); 45 CFR 144.103.
\487\ 42 U.S.C. 18011; 45 CFR 147.140.
\488\ Grandmothered plans, also known as ``transitional'' plans,
are certain non-grandfathered health insurance coverage in the
individual and small group market that are not considered to be out
of compliance with certain specified market reforms under certain
conditions. See Ctrs. for Medicare & Medicaid Servs., Extended Non-
Enforcement of Affordable Care Act-Compliance With Respect to
Certain Policies (Mar. 23, 2022), https://www.cms.gov/files/document/extension-limited-non-enforcement-policy-through-calendar-year-2023-and-later-benefit-years.pdf.
\489\ 42 U.S.C. 300gg-91(c); 45 CFR 144.103, Sec. 146.145(b),
Sec. 148.220. Excepted benefits are a tri-Department matter
regulated by the Departments of HHS, Labor, and the Treasury. In
this proposed rule, we cite to HHS regulations, but note that the
Departments of Labor and the Treasury have parallel regulatory
citations.
\490\ Short-term limited duration insurance is a type of health
insurance coverage that is not subject to most of the provisions of
title XXVII of the Public Health Service Act because it is
specifically excluded from the definition of individual health
insurance coverage in the PHS Act. 42 U.S.C. 300gg-91(b)(5). Short-
term limited duration insurance is generally defined in Federal
regulations as health insurance coverage issued under a contract
that is effective for less than 12 months, and, taking into account
renewals or extensions, has a duration of no longer than 36 months
in total. 45 CFR 144.103. Short-term limited duration insurance is
regulated by the Departments of HHS, Labor, and the Treasury. In
this proposed rule, we cite to HHS regulations, but note that the
Departments of Labor and the Treasury have parallel regulatory
citations.
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We recognize that many of these health insurance products are not
subject to the ACA's market reforms codified in title XXVII of the PHS
Act \491\ in the same fashion as QHPs and other non-grandfathered
health insurance coverage. For instance, large group market plans and
grandfathered plans are subject to some but not all of the market
reforms,\492\ whereas excepted benefits and short-term limited duration
insurance are generally exempt from all of the ACA's market reforms.
Excepted benefits are statutorily defined benefits that are exempt from
certain health care requirements, such as the ACA's market
[[Page 47876]]
reforms \493\ and the nondiscrimination and portability requirements of
HIPAA \494\ when certain conditions are met, such as when benefits are
supplemental to other medical benefits, when benefits are limited in
scope, or when the benefits are provided as independent, non-
coordinated benefits.\495\ Examples of excepted benefits include
limited scope vision insurance and limited scope dental insurance
(though stand-alone dental plans sold through the Exchange are subject
to certain QHP requirements \496\), long term care insurance, specified
disease insurance, and Medicare supplemental health insurance (also
known as ``Medigap'').
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\491\ 42 U.S.C. 300gg et seq.
\492\ For example, large group market plans and grandfathered
plans are not subject to the ACA's fair health insurance premiums
(42 U.S.C. 300gg) or essential health benefits (42 U.S.C. 300gg-6)
requirements.
\493\ 42 U.S.C. 300gg-21(b)-(c), 300gg-63.
\494\ Public Law 104-191, 100 Stat. 2548 (1996).
\495\ 42 U.S.C. 300gg-91(c); 29 U.S.C. 1191b(c).
\496\ See, e.g., 45 CFR 155.1065, Sec. 156.150.
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Public comments received from health insurance entities on the 2015
and 2019 NPRMs opposed application of Section 1557 nondiscrimination
requirements to excepted benefits and short-term limited duration
insurance.\497\ The 2020 Rule narrowed the scope of application to
health insurance at Sec. 92.3(b)-(c) to provide that an issuer
principally engaged in the business of providing health insurance shall
not, by virtue of such provision, be covered by Section 1557 in all of
its operations. This resulted in coverage of an issuer's operations
only with respect to the particular line or sub-line of business for
which the issuer receives Federal financial assistance, which
effectively exempts coverage of excepted benefits and short-term
limited duration insurance from the requirements established under the
2020 Rule.\498\
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\497\ See 81 FR 31375, 31430-31 (May 18, 2016); 85 FR 37160,
37173 (June 19, 2020).
\498\ See 85 FR 37173.
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Unlike the 2020 Rule, this proposed rule would apply to all of an
issuer's health programs and activities when an issuer is principally
engaged in providing or administering health insurance coverage, or
other health-related coverage as specified under paragraph (b) in the
proposed definition of ``health program or activity'' under proposed
Sec. 92.4.\499\ The fact that excepted benefits and short-term limited
duration insurance are exempt from the ACA's market reforms because
they are not intended to serve as comprehensive medical insurance does
not negate that offering such insurance is a ``health program or
activity.'' Further, the text of Section 1557 does not limit its
protections only to health programs and activities that are subject to
other provisions of the ACA. However, because the Department believes
commenters' concerns about the application of Section 1557 to excepted
benefits and short-term limited duration insurance warranted further
consideration, we have provided additional discussion on how OCR
proposes to analyze allegations of discrimination in such products in
the preceding discussion on benefit design.
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\499\ We note that some health insurance issuers may be
considered principally engaged in the business of providing health
care as defined under the 2020 Rule at Sec. 92.3(b), such as
issuers offering HMO plans.
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Application to Third Party Administrators
An issuer's or other entity's operations related to third party
administrative services also would be subject to the rule when the
issuer receives Federal financial assistance and is deemed to be
principally engaged in the provision or administration of health
programs or activities as described in paragraph (a) of the proposed
definition of ``health program or activity'' under proposed Sec. 92.4,
which includes providing or administering health-related services,
health insurance coverage, or other health-related coverage. We
recognize that the Employee Retirement Income Security Act of 1974
(ERISA) requires group health plans to be administered consistent with
their terms,\500\ and, therefore, third party administrators are unable
to change any discriminatory design features in the self-insured plans
they administer to comply with Section 1557's requirements. In the 2016
Rule, we clarified that third party administrators were generally not
responsible for the benefit designs of the self-insured group health
plans they administer and that enforcing Section 1557 against a third
party administrator for a group health plan with a discriminatory
benefit design could result in holding a third party administrator
liable for plan designs over which it had no control. Some third party
administrators, however, are responsible for the development of the
group health plan document or other policy documents that are
ultimately adopted by the self-insured plan. Under these circumstances,
where the discriminatory terms of the group health plan originated with
the third party administrator rather than with the plan sponsor, the
third party administrator could be liable for the discriminatory design
feature under Section 1557.\501\
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\500\ ERISA Section 404(a)(1)(D) (29 U.S.C. 1104(a)(1)(D)).
\501\ See Tovar v. Essentia Health, 342 F. Supp. 3d 947, 954 (D.
Minn. 2018) (holding that a third party administrator may be liable
under Section 1557 for damages arising from discriminatory terms in
a self-insured, employer-sponsored health plan that was under the
sole control of the employer by refusing to construe ERISA to impair
Section 1557 and finding that ``[n]othing in Section 1557,
explicitly or implicitly, suggests that [third party administrators]
are exempt from the statute's nondiscrimination requirements'').
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When OCR receives a complaint alleging discrimination in a self-
insured group health plan administered by a covered entity acting as a
third party administrator, we propose to adopt an approach similar to
the 2016 Rule that takes into account the party responsible for the
alleged discriminatory conduct.\502\ We also restate the 2016 Rule's
position that we will engage in a fact-specific analysis to evaluate
whether a third party administrator is appropriately covered under
Section 1557 as a recipient of Federal financial assistance in
circumstances where the third party administrator is legally separate
from the issuer that receives Federal financial assistance.
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\502\ See 81 FR 31432.
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We also newly address that a third party administrator may be
liable under this part when it is responsible for the underlying
discriminatory plan design feature that is adopted by a group health
plan. This modification is consistent with subsequent case law holding
the same.\503\ Accordingly, OCR will determine whether responsibility
for the decision or alleged discriminatory action lies with the plan
sponsor or with the third party administrator. Where the alleged
discrimination relates to the administration of the plan by a covered
third party administrator, OCR will process the complaint against the
third party administrator because it is the entity responsible for the
decision or other action being challenged in the complaint. For
example, if a third party administrator denies a claim because the
individual's name suggests that they are of a certain race or national
origin, or threatens to expose an employee's transgender or disability
status to the employee's employer, OCR will proceed against the third
party administrator as the entity responsible for the decision. In
addition, OCR will pursue claims
[[Page 47877]]
against the third party administrator in circumstances where the third
party administrator is the entity responsible for developing the
discriminatory benefit design feature that was adopted by the employer.
On the other hand, where the alleged discrimination relates to the
benefit design of a self-insured group health plan that did not
originate with the third party administrator, but rather with the plan
sponsor, OCR will refer the complaint to the EEOC or the DOJ for
potential investigation.
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\503\ See Tovar, 342 F. Supp. at 954 (holding that a third party
administrator may be liable under Section 1557 for damages arising
from discriminatory terms in a self-insured, employer-sponsored
health plan that was under the sole control of the employer by
refusing to construe ERISA to impair Section 1557 and finding that
``[n]othing in Section 1557, explicitly or implicitly, suggests that
[third party administrators] are exempt from the statute's
nondiscrimination requirements'').
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As part of OCR's enforcement authority, OCR has the option of
referring or transferring matters to other Federal agencies with
jurisdiction over the entity. For example, OCR will transfer matters to
the EEOC where OCR lacks jurisdiction over an employer responsible for
the benefit design of an employer-sponsored group health plan.\504\
Complaints alleging discrimination in the Federal Employees Health
Benefits (FEHB) Program, the Federal Employees Dental and Vision
Insurance Program (FEDVIP), or the Federal Long Term Care Insurance
Program (FLTCIP), would be referred to OPM. This Rule does not
determine how or whether any other agency will investigate or enforce
any matter referred or transferred by the Department.
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\504\ See 28 CFR 42.605.
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Network Adequacy
Plan choices regarding provider networks may also violate Section
1557. Network plans offer medical care through a defined set of
providers under contract with the issuer.\505\ Subject to other
applicable Federal and State laws, covered entities have discretion in
developing their networks of providers, establishing reimbursement
rates, and determining cost-sharing for in-network and out-of-network
providers, including excluding coverage for out-of-network care.
Covered entities using provider networks may be subject to certain
network adequacy requirements governed by state and Federal law.\506\
For example, CMS regulations contain network adequacy requirements for
QHPs \507\ (including essential community providers),\508\ Medicare
Advantage plans,\509\ Medicare Part D prescription drug plans,\510\ and
Medicaid managed care plans.\511\ Several of these regulations
prescribe specific requirements, such as listing the types of providers
that must be included in the network \512\ and establishing time and
distance standards for providers within a certain area.\513\ QHPs that
maintain a provider network must ensure that the provider network
consisting of in-network providers includes essential community
providers and is ``sufficient in number and types of providers,
including providers that specialize in mental health and substance
abuse services, to ensure that all services will be accessible without
unreasonable delay.'' \514\ Starting in plan years 2023 and 2024
respectively, QHP issuers on a Federally-facilitated Exchange must meet
time and distance standards, and appointment wait time standards
established by the Federally-facilitated Exchange.\515\
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\505\ 42 U.S.C. 300gg-91(10); 45 CFR 144.103 (defining ``network
plan'' as ``health insurance coverage of a health insurance issuer
under which the financing and delivery of medical care (including
items and services paid for as medical care) are provided, in whole
or in part, through a defined set of providers under contract with
the issuer'').
\506\ Network adequacy refers to ``a health plan's ability to
deliver the benefits promised by providing reasonable access to
enough in-network primary care and specialty physicians, and all
health care services included under the terms of the contract.''
Network Adequacy, Nat'l Ass'n of Ins. Comm'rs, https://content.naic.org/cipr_topics/topic_network_adequacy.htm (last
updated Aug. 25, 2021).
\507\ 45 CFR 156.230; see also Patient Protection and Affordable
Care Act; HHS Notice of Benefit and Payment Parameters for 2023, 87
FR 27208, 27322-34 (May 6, 2022) (discussing changes to network
adequacy requirements for qualified health plans at 45 CFR 156.230);
U.S. Dep't of Health & Human Servs., Ctrs. for Medicare & Medicaid
Servs., 2023 Letter to Issuers in the Federally-facilitated
Exchanges, pp. 10-17 (April 28, 2022), https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Final-2023-Letter-to-Issuers.pdf.
\508\ 45 CFR 156.235; see also 87 FR 27334-37 (discussing
changes to the essential community providers requirements for
qualified health plans at 45 CFR 156.235).
\509\ See e.g., 42 CFR 422.116; U.S. Dep't of Health & Human
Servs., Ctrs. for Medicare & Medicaid Servs., Medicare Advantage and
Section 1876 Cost Plan Network Adequacy Guidance (2020), https://www.cms.gov/files/document/medicareadvantageandsection1876costplannetworkadequacyguidance6-17-2020.pdf.
\510\ 42 CFR 423.120(a).
\511\ 42 CFR 438.68 (requiring states to establish specified
network adequacy requirements).
\512\ 42 CFR 422.116(b) (Medicare Advantage); Sec. 438.68(b)
(Medicaid).
\513\ 42 CFR 422.116(d) (Medicare Advantage); Sec. 423.120 (a)
(Part D); Sec. 438.68(c) (Medicaid).
\514\ 45 CFR 156.230(a)(1)-(2).
\515\ 87 FR 27322-34 (discussing changes to network adequacy
requirements for qualified health plans at 45 CFR 156.230).
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Recognizing that network adequacy is regulated by other
departmental regulations, we noted in the 2016 Rule, and again note
here, that it is outside the scope of Section 1557 to establish uniform
or minimum network adequacy standards. Nonetheless, the prevalence of
narrow networks continues to grow as payers seek to keep premiums and
costs low and drive patients to high-value providers.\516\ Provider
networks that limit or deny access to care for individuals with certain
disabilities, such as by excluding certain providers from the network
that treat high-cost enrollees, raise discrimination concerns.\517\
Similarly, limited provider networks may require transgender enrollees
to visit inexperienced providers in order to receive services,
regardless of the potentially serious risks from receiving inadequate
care. Enrollees are often required to prove why an in-network provider
cannot meet their needs before their insurance will cover an out-of-
network provider, raising additional obstacles that may cause
particular harm to individuals with disabilities, transgender people,
or other groups.\518\
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\516\ Steven Findlay, In Search Of Insurance Savings, Consumers
Can Get Unwittingly Wedged Into Narrow-Network Plans, Kaiser Health
News (Nov. 1, 2018), https://khn.org/news/in-search-of-insurance-savings-consumers-can-get-unwittingly-wedged-into-narrow-network-plans/ (discussing 73% of plans offered through the Exchange in 2018
had restrictive networks compared to 54% in 2015).
\517\ See Valarie K. Blake, Restoring Civil Rights to the
Disabled in Health Insurance, 95 Neb. L. Rev. 1071, 1086 (2016),
https://digitalcommons.unl.edu/cgi/viewcontent.cgi?article=3046&context=nlr; see also, Mark Shepard,
Nat'l Bureau of Econ. Research, Working Paper 22600: Hospital
Network Competition & Adverse Selection: Evidence from the
Massachusetts Health Insurance Exchange (2016), https://www.nber.org/papers/w22600 (finding high-cost enrollees favor plans
that include expensive ``star'' hospitals in their network, which
incentivizes plans not to include such hospitals in their networks);
Subodh Potla et al., Access to Neurosurgery in the Era of Narrowing
Insurance Networks: Statewide Analysis of Patient Protection and
Affordable Care Act Marketplace Plans in Arizona, 149 World
Neurosurgery e963 (May 2021), https://pubmed.ncbi.nlm.nih.gov/33515792/ (finding 67 percent of counties in Arizona do not have
access to outpatient neurosurgical care despite the presence of
neurosurgical facilities in most counties); Stephen M. Schleicher et
al., Effects of Narrow Networks on Access to High-Quality Cancer
Care, 2 JAMA Oncology 427 (2016), https://jamanetwork.com/journals/jamaoncology/article-abstract/2499779 (finding more than half of
Exchange plans excluded four of eleven cancer centers).
\518\ Health Insurance--Choosing a Plan, Transgender Legal
Defense & Education Fund, Trans Health Project, https://transhealthproject.org/trans-health-insurance-tutorial/choosing-plan/ (last updated July 16, 2020).
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We understand that an array of factors can affect the provider
network design of a plan, including the geographic location of the
service area, the number of available providers and specialists in the
service area, reimbursement rates, the number of providers willing to
contract with the payer, and the overall design of the plan as it
relates to premiums. We recognize plans' and issuers' autonomy in
developing their provider networks as part of their benefit design
packages, consistent with existing state and Federal network adequacy
and other laws, and we do not
[[Page 47878]]
propose to prescribe specific network adequacy requirements for covered
entities under this rule. However, to ensure compliance with Section
1557, payers must develop their networks in a manner that does not
discriminate against enrollees on the basis of race, color, national
origin, sex, age, or disability.
We generally seek comment on how Section 1557 might apply to:
provider networks; how provider networks are developed, including
factors that are considered in the creation of the network and steps
taken to ensure that an adequate number of providers and facilities
that treat a variety of health conditions are included in the network;
the ways in which provider networks limit or deny access to care for
individuals on the basis of race, color, national origin, sex, age, or
disability; and the extent to which the lack of availability of
accessible medical diagnostic equipment in a provider network limits or
denies access to care for individuals with disabilities.
In addition, the Department is also aware of growing concerns
regarding impermissible discrimination in the application of value
assessment methodologies used to set valuations for health care goods
and services. Value assessment methodologies are an important tool to
support health care payers in their coverage decisions and can
significantly influence health benefit design, particularly through
their use in price negotiations and value-based purchasing
arrangements, as well as by informing utilization management decisions.
However, where value assessment makes use of methods for calculating
value that penalize individuals or groups of individuals on the basis
of race, color, national origin, sex, age, or disability (e.g., by
placing a lower value on life-extension for a group of individuals
based on a protected basis or via inappropriate adjustment of clinical
end points on the basis of a protected basis under Section 1557), they
may violate this part. To that end, OCR seeks comment on the extent,
scope and nature of value assessment methods that discriminate on the
basis of race, color, national origin, sex, age, or disability. We are
interested in feedback on the civil rights implications of value
assessment across a wide variety of contexts, including utilization
management, formulary design, price negotiations, alternative payment
models and other relevant applications.
Finally, we seek comment on all aspects of this section. In
particular, we seek comment on the anticipated impact of the proposed
application to excepted benefits and short-term limited duration
insurance plans when such products are offered by a covered entity; how
the proposed rule's nondiscrimination requirements would impact the
industry that offers excepted benefits and short-term limited duration
insurance and the consumers who rely upon those products; the
prevalence of excepted benefits and short-term limited duration
insurance offered by covered entities and the standard industry
practices under which such plans are designed and administered; and
excepted benefits and short-term limited duration insurance plans'
scope of coverage, types of exclusions and limitations, underwriting
practices, premium setting, and actuarial or business justifications
for industry practices (as applicable), that may raise concerns about
discrimination under Section 1557.
Prohibition on Sex Discrimination Related to Marital, Parental, or
Family Status (Sec. 92.208)
The Department proposes in Sec. 92.208 to provide that covered
entities are prohibited from discriminating on the basis of sex in
their health programs and activities with respect to an individual's
marital, parental, or family status. The 2016 and 2020 Final Rules did
not include a similar provision. This is not a new concept, however, as
it is similar to the Department's Title IX regulation.\519\
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\519\ 45 CFR 86.40(a).
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The Department is proposing this provision to address issues OCR
has encountered in its Section 1557 enforcement work. For example, OCR
has resolved complaints against covered entities with policies of
automatically assigning a male spouse as the guarantor when a female
spouse received medical services, while not automatically assigning a
female spouse as the guarantor when a male spouse received medical
services.\520\
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\520\ Sex Case Summaries: Summary of Selected OCR Compliance
Activities, Dep't of Health & Human Servs., Office for Civil Rights,
https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/examples/sex-discrimination/ (last updated
Feb. 21, 2017).
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Proposed Sec. 92.208 thus would provide that, in determining
whether an individual satisfies any policy or criterion regarding
access to its health programs or activities, a covered entity must not
take an individual's sex into account in applying any rule concerning
an individual's current, perceived, potential, or past marital,
parental, or family status.
The Department is also considering whether Sec. 92.208 should
include a provision to specifically address discrimination on the basis
of pregnancy-related conditions.\521\ Although neither the 2016 nor the
2020 Rules included a stand-alone provision prohibiting discrimination
on the basis of pregnancy-related conditions, the 2016 Rule defined
discrimination ``on the basis of sex'' to include, inter alia,
discrimination on the basis of ``pregnancy, false pregnancy,
termination of pregnancy, or recovery therefrom, childbirth or related
medical conditions.'' \522\ The 2020 Rule does not include a definition
of ``on the basis of sex'' at all, and therefore does not specifically
include in the Section 1557 regulation a prohibition on discrimination
on the basis of a person's ``termination of pregnancy'' or other
conditions related to pregnancy.
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\521\ Such a provision would supplement proposed 92.101(a)(2),
in which the Department proposes to define ``on the basis of sex''
to include pregnancy discrimination. See discussion supra Sec.
92.101(a)(2).
\522\ Former 45 CFR 92.4. Although the Franciscan Alliance court
vacated the inclusion of the term ``termination of pregnancy'' in
the 2016 Rule's definition of discrimination on the basis of sex,
that vacatur neither applies to this current rulemaking, nor to a
possible new final provision prohibiting discrimination on the basis
of pregnancy-related conditions.
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The 2020 Rule does, however, prohibit discrimination on any of the
``grounds'' prohibited under Title IX,\523\ and the Department's Title
IX regulation, in turn, includes a provision expressly prohibiting
discrimination on the basis of pregnancy-related conditions, including
childbirth, false pregnancy, termination of pregnancy, and recovery
therefrom.\524\ Under this proposed rule, too, recipients would be
required to comply with the specific prohibitions on discrimination
found in the Department's Title IX regulations (including the
regulation prohibiting discrimination on the basis of pregnancy-related
conditions, including childbirth, false pregnancy, termination of
pregnancy, and recovery therefrom).\525\ In that respect it would not
deviate from the 2016 or the 2020 Rule.
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\523\ 45 CFR 92.2(a), (b)(2).
\524\ 45 CFR 86.40(a).
\525\ See proposed 45 CFR 92.101(b).
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At the same time the Department promulgated the 2020 Rule, the
Department amended its Title IX regulations to expressly include Title
IX's statutory abortion neutrality provision,\526\ and included in the
Department's Section 1557 regulation a provision stating that the
Section 1557 regulations may not be applied insofar as they would
``depart from, or contradict,'' Title IX exemptions, rights,
[[Page 47879]]
or protections.\527\ This aspect of the 2020 Rule has been challenged
in litigation.\528\ This NPRM proposes repealing 45 CFR 92.6(b), the
provision of the 2020 Rule challenged in those cases. The Department's
view is that Section 1557 does not require the Department to
incorporate the language of Title IX's abortion neutrality provision
\529\ into its Section 1557 regulation. This approach is consistent
with the 2016 rule, which also did not incorporate Title IX's abortion
neutrality provision. We acknowledge that the Franciscan Alliance court
vacated the challenged provisions of the 2016 rule and reasoned that
the Department was required to incorporate the language of Title IX's
abortion neutrality provision; however, we disagree with that decision,
which does not bind this new rulemaking.
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\526\ See 85 FR 37243 (promulgating 45 CFR 86.18(b)).
\527\ See 45 CFR 92.6(b)).
\528\ See BAGLY v. U.S. Dep't of Health & Human Servs., No.
1:20-cv-11297 (D. Mass. Sept. 18, 2020); New York v. U.S. Dep't of
Health & Human Servs., No. 1:2-cv-00583 (S.D.N.Y. July 20, 2020).
This NPRM proposes repealing 45 CFR 92.6(b), the provision of the
2020 Rule challenged in those cases.
\529\ 20 U.S.C. 1688 (``Nothing in this chapter shall be
construed to require or prohibit any person, or public or private
entity, to provide or pay for any benefit or service, including the
use of facilities, related to an abortion. Nothing in this section
shall be construed to permit a penalty to be imposed on any person
or individual because such person or individual is seeking or has
received any benefit or service related to a legal abortion.'').
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The Department does note, however, that there are several other
statutory and regulatory provisions related to the provision of
abortions that may apply to an entity covered by Section 1557, and OCR
will apply such provisions consistent with the law. For example, the
Weldon Amendment forbids funds appropriated to HHS, among other
Departments, from being ``made available to a Federal agency or
program, or to a state or local government, if such agency, program, or
government subjects any institutional or individual health care entity
to discrimination on the basis that the health care entity does not
provide, pay for, provide coverage of, or refer for abortions.'' \530\
The Coats-Snowe Amendment forbids discriminating against an entity that
refuses to undergo training in performance or referrals for
abortions.\531\ The Church Amendment forbids requiring any individual
``to perform or assist in the performance of any part of a health
service program . . . if his performance or assistance in the
performance of such part of such program . . . would be contrary to his
religious beliefs or moral convictions.'' \532\ It also provides that
an entity's receipt of any grant, contract, loan, or loan guarantee
under the Public Health Service Act, the Community Mental Health
Centers Act, or the Developmental Disabilities Services and Facilities
Construction Act ``does not authorize any court or any public official
or other public authority to require . . . such entity to . . . make
its facilities available for the performance of any sterilization
procedure or abortion if the performance of such procedure or abortion
in such facilities is prohibited by the entity on the basis of
religious beliefs or moral convictions.'' \533\ The Church Amendment
also prohibits discrimination against health care personnel related to
their employment or staff privileges because they ``performed or
assisted in the performance of a lawful sterilization procedure or
abortion.'' \534\ The same nondiscrimination protections also apply to
health care personnel who refuse to perform or assist in the
performance of sterilization procedures or abortion.\535\ In addition,
some of HHS' programs and services are specifically governed by
abortion restrictions in the underlying statutory authority or program
authorization.\536\
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\530\ Consolidated Appropriations Act, 2022, Public Law 117-103,
div. H, title V General Provisions, sec. 507(d)(1) (Mar. 15, 2022).
See also, e.g., the ``Hyde Amendment,'' Consolidated Appropriations
Act, 2021, Public Law 116-260, div. H, Sec. Sec. 506-07, 134 Stat.
1182 (Dec. 27, 2020).
\531\ 42 U.S.C. 238n(a).
\532\ 42 U.S.C. 300a-7(d).
\533\ Id. 300a-7(b)(2)(A).
\534\ Id. 300a-7(c)(1). For more information, see Guidance on
Nondiscrimination Protections under the Church Amendments, U.S.
Dep't of Health & Hum. Servs., https://www.hhs.gov/conscience/conscience-protections/guidance-church-amendments-protections/ (last updated Sept. 17, 2021).
\535\ Id.
\536\ See, e.g., Title X of the PHS Act, 24 U.S.C. 300a-6;
Section 1303(b)(4) of the ACA, 42 U.S.C. 18023.
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The Department also notes in this regard that the Emergency Medical
Treatment and Active Labor (EMTALA) provides rights to individuals when
they seek examination or treatment and appear at an emergency
department of a hospital that participates in Medicare.\537\ If that
person has an ``emergency medical condition,'' the hospital must
provide available stabilizing treatment, including abortion, or an
appropriate transfer to another hospital that has the capabilities to
provide available stabilizing treatment, notwithstanding any directly
conflicting state laws or mandate that might otherwise prohibit or
prevent such treatment.
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\537\ 42 U.S.C. 1395dd. For more information, see Letter to
State Survey Agency Directors from U.S. Dep't of Health & Human
Servs., Ctrs. for Medicare & Medicaid Servs., Directors, Quality,
Safety & Oversight Group and Survey & Operations Group (July 11,
2022), https://www.cms.gov/files/document/qso-22-22-hospitals.pdf.
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The Department believes it could be beneficial to include a
provision specifically prohibiting discrimination on the basis of
pregnancy-related conditions as a form of sex-based discrimination. We
seek comment on whether and how the Department should do so. We also
seek comment on what impact, if any, the Supreme Court decision in
Dobbs v. Jackson Women's Health Organization \538\ has on the
implementation of Section 1557 and these regulations. In light of the
Dobbs decision and E.O. 14076,\539\ the Department also seeks comments
on other approaches to ensure nondiscriminatory access to care under
this provision.
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\538\ 142 S. Ct. 2228 (2022).
\539\ 87 FR 42053 (July 8, 2022).
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Though Congress did not require the Department to incorporate the
language of Title IX abortion-neutrality provision in its Section 1557
regulations, we seek comment on this approach and on other possible
readings of the Title IX abortion-neutrality provision, as well as
whether the Department should align its Title IX regulation regarding
the abortion neutrality provision of Title IX with the 2000 ``Common
Rule'' version of that regulatory provision that more than 20 agencies
have long adopted.\540\
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\540\ See 65 FR 52869 (Aug. 30, 2000); see also, e.g., 28 CFR
54.235(d)(1) (DOJ regulation). The agencies that have adopted the
Common Rule include: Agency for International Development, 22 CFR
pt. 229; Corporation for National and Community Service, 45 CFR pt.
2555; Department of Agriculture, 7 CFR pt. 15d.; Department of
Commerce, 15 CFR pt. 8a; Department of Defense, 32 CFR pt. 196;
Department of Energy, 10 CFR 1040; Department of Homeland Security,
6 CFR pt. 17; Department of Housing and Urban Development, 24 CFR
pt. 3; Department of the Interior, 43 CFR pt. 41; Department of
Justice, 28 CFR pt. 54; Department of Labor, 29 CFR pt. 36;
Department of State, 22 CFR pt. 146; Department of Transportation,
49 CFR pt. 25; Department of the Treasury, 31 CFR pt. 28; Department
of Veterans Affairs, 38 CFR pt. 23; Environmental Protection Agency,
40 CFR pt. 5; Federal Emergency Management Agency, 44 CFR pt. 19;
General Services Administration, 41 CFR pt. 101-4; National
Aeronautics and Space Administration, 14 CFR pt. 1253; National
Archives and Records Administration, 36 CFR pt. 1211; National
Science Foundation, 45 CFR pt. 618; Nuclear Regulatory Commission,
10 CFR pt. 5; Small Business Administration, 13 CFR pt. 113; and
Tennessee Valley Authority, 18 CFR pt. 1317.
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Nondiscrimination on the Basis of Association (Sec. 92.209)
Proposed Sec. 92.209 prohibits discrimination against an
individual on the basis of the race, color, national origin, sex, age,
or disability of an individual with whom the individual is
[[Page 47880]]
known to have a relationship or association. Longstanding
interpretations of existing civil rights laws recognize claims of
associational discrimination, where the basis is a characteristic of
the harmed individual or an individual who is associated with the
harmed individual.\541\ In addition, the proposed prohibition on
associational discrimination under Section 1557 corresponds with the
specific prohibition of discrimination based on association with an
individual with a disability under Section 504.\542\
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\541\ See Kengerski v. Harper, No. 20-1307, 2021 WL 3199225 (3d
Cir. 2021) (a white plaintiff employee's claim is justiciable under
an associational discrimination legal theory under Title VII of the
Civil Rights Act of 1964, where his employer retaliated against him
for complaining about a supervisor's racist remarks directed at the
employee's biracial family member and other minority coworkers);
Kelleher v. Fred A. Cook, Inc., 939 F.3d 465 (2d Cir. 2019) (an
employer's reaction to a non-disabled employee's reasonable
accommodation request to care for disabled dependent can support an
inference of associational discrimination); McGinest v. GTE Serv.
Corp., 360 F.3d 1103, 1118 (9th Cir. 2004) (case involving indirect
comments in the workplace that crossed racial lines, noting that
``Title VII has . . . been held to protect against adverse
employment actions taken because of the employee's close association
with black friends or coworkers'') (internal citations omitted);
Johnson v. Univ. of Cincinnati, 215 F.3d 561, 574 (6th Cir. 2001) (a
plaintiff who is not a member of a recognized protected class
nevertheless alleges a cognizable discrimination claim under Title
VII and 42 U.S.C. 1981 if he alleges that he was discriminated
against based on his association with a member of a recognized
protected class); Tetro v. Elliot Popham Pontiac, Oldsmobile, Buick
& GMC Trucks Inc., 173 F.3d 988, 994-95 (6th Cir. 1999) (holding
that white plaintiff with biracial child stated a claim under Title
VII based on his own race ``even though the root animus for the
discrimination is a prejudice against the biracial child''); Parr v.
Woodmen of the World Life Ins., 791 F.2d 888, 892 (11th Cir. 1986)
(``Where a plaintiff claims discrimination based upon an interracial
marriage or association, he alleges by definition that he has been
discriminated against because of his race.''); Arceneaux v.
Vanderbilt Univ., 25 Fed. App'x. 345 (6th Cir. 2001) (unpub'd)
(treating sex discrimination as associational discrimination). Cf.
Loving v. Va., 388 U.S. 1 (1967).
\542\ 29 U.S.C. 794a(a)(2); see also McCullum v. Orlando Reg'l
Healthcare Sys., Inc., 768 F.3d 1135, 1142 (11th Cir. 2014) (``[i]t
is widely accepted that under both the [Rehabilitation Act] and the
ADA, non-disabled individuals have standing to bring claims when
they are injured because of their association with a disabled
person.''); Loeffler v. Staten Island Univ. Hosp., 582 F.3d 268, 279
(2d Cir. 2009) (permitting associational discrimination claim under
Section 504). See also, 42 U.S.C. 12182(b)(1)(E) (ADA); Falls v.
Prince George's Hosp. Ctr., No. 97-1545, 1999 WL 33485550 (D. Md.
Mar. 16, 1999) (holding that parent had an associational
discrimination claim under Title III of the ADA because hospital
directly discriminated against parent by requiring hearing parent to
act as interpreter for child who was deaf). See generally U.S. Equal
Emp't Opportunity Comm'n, Association Q&A, supra note 396.
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The proposed provision is consistent with the former Sec. 92.209
in the 2016 Rule, which was repealed by the 2020 Rule. OCR received
many comments in response to the 2015 and 2019 NPRMs favoring the
inclusion of an explicit provision in Section 1557 prohibiting
discrimination on the basis of association.\543\ Of particular note,
the preamble to the 2020 Rule acknowledged that commenters opposed the
repeal of former Sec. 92.209 because: removing such protections would
cause confusion; the lack of reference to associational discrimination
in the regulatory text is inconsistent with existing case law; and
specific protected populations are more susceptible to associational
discrimination.\544\
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\543\ See 81 FR 31375, 31438-39 (May 18, 2016); 85 FR 37160,
37199 (June 19, 2020).
\544\ 85 FR 37199.
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The Department agrees that additional clarity is beneficial in this
area, as OCR continues to see complaints alleging discrimination based
on association. For example, under this provision, a medical practice
may not refuse to see a prospective female patient based, in part, on
the knowledge that the patient has a female spouse or partner because
the refusal would be based on the sex of the prospective patient and on
the sex of an individual with whom the patient is known to have a
relationship or association.
Use of Clinical Algorithms in Decision-Making (Sec. 92.210)
Proposed Sec. 92.210 states that a covered entity must not
discriminate against any individual on the basis of race, color,
national origin, sex, age, or disability through the use of clinical
algorithms in its decision-making. This is a new provision, and this
topic has not been addressed in previous Section 1557 rulemaking. The
Department believes it is critical to address this issue explicitly in
this rulemaking given recent research demonstrating the prevalence of
clinical algorithms that may result in discrimination.\545\ Further,
the Department became aware that clinical algorithms in state Crisis
Standards of Care plans used during the COVID-19 pandemic may be
screening out individuals with disabilities, as discussed in more
detail below. OCR believes that proposed Sec. 92.210 would put covered
entities on notice that they cannot use discriminatory clinical
algorithms and may need to make reasonable modifications in their use
of the algorithms, unless doing so would cause a fundamental alteration
to their health program or activity. The intent of proposed Sec.
92.210 is not to prohibit or hinder the use of clinical algorithms but
rather to make clear that discrimination that occurs through their use
is prohibited.
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\545\ See infra note 547.
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While covered entities are not liable for clinical algorithms that
they did not develop, they may be held liable under this provision for
their decisions made in reliance on clinical algorithms. Covered
entities using clinical algorithms in their decision-making should
consider clinical algorithms as a tool that supplements their decision-
making, rather than as a replacement of their clinical judgment. By
over-relying on a clinical algorithm in their decision-making, such as
by replacing or substituting their own clinical judgment with a
clinical algorithm, a covered entity may risk violating Section 1557 if
their decision rests upon or results in discrimination.
Clinical algorithms are tools used to guide health care decision-
making and can range in form from flowcharts and clinical guidelines to
complex computer algorithms, decision support interventions, and
models. End-users, such as hospitals, providers, and payers (e.g.,
health insurance issuers) use these systems to assist with decision-
making for various purposes. Clinical algorithms are used for
screening, risk prediction, diagnosis, prognosis, clinical decision-
making, treatment planning, health care operations, and allocation of
resources,\546\ all of which affect the care that individuals receive.
Recent studies have found that health care tools using clinical
algorithms may create or contribute to discrimination on the bases
protected by Section 1557, and as a result of their use by covered
entities in their health care decision-making may lead to poorer health
outcomes among members of historically marginalized communities.\547\
---------------------------------------------------------------------------
\546\ U.S. Dep't of Health & Human Servs., Agency for Healthcare
Research & Quality, Impact of Healthcare Algorithms on Racial
Disparities in Health and Healthcare (Jan. 25, 2022), https://effectivehealthcare.ahrq.gov/products/racial-disparities-health-healthcare/protocol; see also Sahar Takshi, Unexpected Inequality:
Disparate-Impact from Artificial Intelligence in Healthcare
Decisions, 34 J. L. & Health 215, 219 (2021), https://engagedscholarship.csuohio.edu/cgi/viewcontent.cgi?article=1580&context=jlh; Christina Badaracco,
Avalere, AI in Healthcare: 5 Areas in Which Artificial Intelligence
Is Disrupting the Status Quo (Dec. 16, 2019), https://avalere.com/insights/ai-in-healthcare-5-areas-in-which-artificial-intelligence-is-disrupting-the-status-quo (including preventive health and risk
assessment; diagnosis, precision medicine, drug development, and
administration and care delivery).
\547\ See, e.g., Darshali A. Vyas et al., Hidden in Plain
Sight--Reconsidering the Use of Race Correction in Clinical
Algorithms, 383 N. Engl. J. Med. 874, 876-78 (Aug. 27, 2020); Ziad
Obermeyer et al., Dissecting Racial Bias in an Algorithm Used to
Manage the Health of Populations, 366 Science 447 (Oct. 2019),
https://doi.org/10.4018/978-1-7998-7888-9.ch001; Donna M.
Christensen et al., Medical Algorithms Are Failing Communities of
Color, Health Affairs Blog (Sept. 9, 2021), https://www.healthaffairs.org/do/10.1377/hblog20210903.976632/full/;
Kristine Gloria, Aspen Digital, Center for Inclusive Growth, Power
and Progress in Algorithmic Bias (2021), https://www.aspeninstitute.org/wp-content/uploads/2021/07/Power-Progress-in-Algorithmic-Bias-July-2021.pdf.
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[[Page 47881]]
Clinical algorithms commonly include clinical and sociodemographic
variables and measures of health care utilization.\548\ Race and
ethnicity are often used as explicit input variables. Known as ``race
correction'' or ``race norming,'' this practice adjusts an algorithm's
output on the basis of a patient's race or ethnicity.\549\ The use of
``race norming'' notably garnered public attention when the National
Football League (NFL) pledged to end the practice of adjusting the
results of cognitive functioning tests based on race to determine
settlement amounts for brain injury claims of former NFL players.\550\
---------------------------------------------------------------------------
\548\ U.S. Dep't of Health & Human Servs., Agency for Healthcare
Research & Quality, Healthcare Algorithms, supra note 546.
\549\ Vyas, supra note 547, at 876-78 (2020).
\550\ Will Hobson, How ``Race-Norming'' Was Built into the NFL
Concussion Settlement, Wash. Post (Aug. 2, 2021), https://www.washingtonpost.com/sports/2021/08/02/race-norming-nfl-concussion-settlement/ (explaining race adjustments in cognitive
test scores emanate from studies in the 1990s finding that some
people of color, including Black people, performed worse than white
people on cognitive tests).
---------------------------------------------------------------------------
Another example of this practice can be found in the clinical tools
that evaluate kidney function. Many such tools employ an estimation of
glomerular filtration rate (eGFR) that includes race as a factor to
reflect that Black people have been associated with higher levels of
blood creatinine than white people.\551\ The option for entering race
in the eGFR is limited to a binary ``black/non-black'' option. The eGFR
adjusts the score for Black patients, making their kidneys register as
16 percent healthier than white patients' kidneys even though Black
Americans are about four times as likely to have kidney failure as
white Americans and make up more than 35 percent of people on dialysis
while representing only 13 percent of the U.S. population.\552\ This
race-based practice reduces the number of Black people placed on
transplant lists and referred for kidney disease management, nephrology
specialists, and dialysis planning.\553\
---------------------------------------------------------------------------
\551\ See Lundy Braun et al, Racialized Algorithms for Kidney
Function: Erasing Social Experience, 286 J. Soc. Science & Med.
113548, p. 5 (2021), https://doi.org/10.1016/j.socscimed.2020.113548
(discussing how race correction in eGFR is rooted in the assumption
that Black individuals as a group are biologically distinct and have
higher muscle mass than other groups, which was based on studies
from the 1970s, without considering ``the complexity of national
origin, socioeconomic status, the bodily effects of racism, and
other unexplored considerations that influence kidney function'').
\552\ See, e.g., Nwamaka D. Eneanya et al., Race-Free Biomarkers
to Quantify Kidney Function: Health Equity Lessons Learned From
Population Based Research, 77 Am. J. of Kidney Diseases 667 (2021),
https://doi.org/10.1053/j.ajkd.2020.12.001; Lesley A. Inker et al.,
A New Panel-Estimated GFR, Including [beta]2-Microglobulin and
[beta]-Trace Protein and Not Including Race, Developed in a Diverse
Population, 77 Am. J. of Kidney Diseases 673 (2021), https://doi.org/10.1053/j.ajkd.2020.11.005; Salman Ahmed et al., Examining
the Potential Impact of Race Multiplier Utilization in Estimated
Glomerular Filtration Rate Calculation on African-American Care
Outcomes, 36 J. of Gen. Internal Med. 464, 466-67 (2021), https://link.springer.com/content/pdf/10.1007/s11606-020-06280-5.pdf.
\553\ See Ahmed, supra note 552, at 467.
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Reliance on the eGFR clinical algorithm may lead to discrimination
against patients based on race and ethnicity. For example,
discrimination concerns arise if a covered entity takes action based on
the algorithmic output that results in less favorable treatment of a
Black patient as compared to white patients with similar or healthier
kidneys because an algorithm determined that a Black patient's kidney
function is better than it actually is.\554\ Concerns with the use of
race in the estimation of GFR in the United States led the National
Kidney Foundation and the American Society of Nephrology to create a
task force on the issue, which ultimately recommended an approach that
does not use race.\555\
---------------------------------------------------------------------------
\554\ See, e.g., Compl., Crowley v. Strong Mem. Hosp. of the
Univ. of Rochester, Civ. No. 21-cv-1078 (W.D.N.Y. Oct. 1, 2021) (22-
year-old biracial individual with kidney disease brought a Title VI
and Section 1557 action against hospital for using a medical
algorithm (eGRF) to assess kidney health that added a race-specific
multiplier for a Black person, which deemed him ineligible for a
kidney transplant).
\555\ See Cynthia Delgado et al., A Unifying Approach for GFR
Estimation: Recommendations of the NKF-ASN Task Force on Reassessing
the Inclusion of Race in Diagnosing Kidney Disease, 79 Am. J. of
Kidney Diseases 268, 283-284 (2022), https://doi.org/10.1053/j.ajkd.2021.08.003 (recommending a new estimating equation for GFR
that does not incorporate race).
---------------------------------------------------------------------------
The practice of ``race norming'' is not limited to eGFR, and also
occurs in the following clinical tools: cardiology (to assess the risk
of heart failure), cardiac surgery (to assess the risk of complications
and death), obstetrics (to determine risks associated with vaginal
birth after cesarean), urology (to assess the risk of kidney stones and
urinary tract infections), oncology (to predict rectal cancer survival
and breast cancer risk), endocrinology (to assess osteoporosis and
fracture risks), and pulmonology (to measure lung function).\556\
Covered entities must be mindful when using tools that rely on racial
or ethnic variables to ensure their reliance on such tools does not
result in discriminatory clinical decisions. We encourage covered
entities to use updated tools that have removed or do not have known
biases, such as the updated eGFR discussed above.
---------------------------------------------------------------------------
\556\ Vyas, supra note 547.
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The Department notes that the use of algorithms that rely upon race
and ethnicity-conscious variables may be appropriate and justified
under certain circumstances, such as when used as a means to identify,
evaluate, and address health disparities.\557\ The Department also
notes that the use of clinical algorithms may result in discriminatory
outcomes when variables are used as a proxy for a protected basis and
may also result from correlations between a variable and a protected
basis.\558\
---------------------------------------------------------------------------
\557\ See e.g., Michelle Tong & Samantha Artiga, Kaiser Family
Foundation, Issue Brief: Use of Race in Clinical Diagnosis and
Decision Making: Overview and Implications (Dec. 9, 2021), https://www.kff.org/racial-equity-and-health-policy/issue-brief/use-of-race-in-clinical-diagnosis-and-decision-making-overview-and-implications/
.
\558\ See, e.g., Obermeyer, supra note 547.
---------------------------------------------------------------------------
The use of clinical algorithms may also result in discrimination
against individuals with disabilities and older adults. This issue
surfaced in connection with Crisis Standards of Care and their use
during the COVID-19 pandemic.\559\ During the COVID-19 public health
emergency, OCR received complaints and requests for technical
assistance related to state Crisis Standards of Care plans. OCR worked
with multiple states to address nondiscrimination in their Crisis
Standards of Care plans and practices, including the states of Alabama,
Arizona, North Carolina, Texas, Tennessee, and Utah.\560\ Crisis
Standards of Care are formal guidelines or policies adopted during an
emergency or crisis that effect substantial change in usual health care
operations and the level of care it is possible to deliver, which is
made necessary by a pervasive or catastrophic disaster. In the
effective marshaling of scarce resources, these standards may authorize
the prioritization of scarce resources through means not permitted
during non-crisis conditions. Crisis Standards of Care may include
clinical algorithms in the form of flowcharts or other assessment tools
intended to assist covered entities in prioritizing patients for scarce
resources.
---------------------------------------------------------------------------
\559\ See U.S. Dep't of Health & Human Servs., Office for Civil
Rights FAQs for Healthcare Providers during the COVID-19 Public
Health Emergency: Federal Civil Rights Protections for Individuals
with Disabilities under Section 504 and Section 1557, Q4 (Feb. 4,
2022), https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/.
\560\ See Civil Rights and COVID-19, supra note 184.
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[[Page 47882]]
Use of such assessment tools for making resource allocation
decisions that screen out or tend to screen out individuals with
disabilities from fully and equally enjoying any health care service,
program, or activity being offered, would violate Section 1557, unless
the criteria used in such tools can be shown to be necessary for the
provision of the service, program or activity being offered.\561\ For
example, to the extent an assessment tool considers a person's current
health status, including a disability, for the purpose of determining a
person's risk of in-hospital mortality as part of its resource
allocation decision-making, such assessment tool might not violate this
part, as consideration of short-term mortality risk is necessary for
the implementation of Crisis Standards of Care. Similarly, assessment
tools should not penalize patients for diminished long-term life-
expectancy.\562\ Assessment tools should not include categorical
exclusions of certain types of disabilities, such as Down syndrome,
when treatment would not be futile for individuals with that type of
disability. As another example, Crisis Standards of Care may rely on
instruments such as the Sequential Organ Failure Assessment (SOFA). The
SOFA score is a scoring tool that assesses the performance of several
organ systems in the body (neurologic, blood, liver, kidney, and blood
pressure/hemodynamics) and assigns a score based on the data obtained
in each category.\563\ The higher the SOFA score, the higher the likely
mortality, and consequently the higher likelihood of de-prioritization
of the patient under many Crisis Standards of Care allocation
frameworks. In addition, the SOFA score includes algorithmic scoring
systems, such as the Glasgow Coma Scale, to assess the likelihood of
mortality. The Glasgow Coma Scale considers whether a person's speech
is comprehensible and whether they obey commands for movement. Someone
with cerebral palsy may have difficulty speaking or moving as part of
their underlying disability, which does not contribute to the short-
term mortality outcomes the instrument is designed to assess.
Adjustments must be made to ensure that such a person's pre-existing
condition, and the symptoms of that condition, are not considered when
using the Glasgow Coma Scale (whether within or outside of the SOFA) to
evaluate whether they qualify for treatment or what priority they will
receive in accessing scarce resources.\564\ When using such tools, an
entity may need to make reasonable modifications as required by
proposed Sec. 92.205 to its use of the assessment tool in order to
avoid discrimination, unless doing so would cause a fundamental
alteration.
---------------------------------------------------------------------------
\561\ See also 42 U.S.C. 12182(b)(2)(A)(i) (ADA).
\562\ See U.S. Dep't of Health & Human Servs., Office for Civil
Rights, supra note 559, at Q4.
\563\ See generally U.S. Dep't of Health & Human Servs., Office
of the Assistant Sec'y for Preparedness & Response, Tech. Res.
Assistance Ctr. & Info. Exchange (TRACIE), SOFA Score: What it is
and How to Use it in Triage (Dec. 21, 2020), https://files.asprtracie.hhs.gov/documents/aspr-tracie-sofa-score-fact-sheet.pdf.
\564\ See U.S. Dep't of Health & Human Servs., Office for Civil
Rights, supra note 559, at Q4. See also Civil Rights and COVID-19,
supra note 184.
---------------------------------------------------------------------------
In addition, the Department notes the existence of an emerging body
of research showing that the SOFA and other prognostic scoring
algorithms used in Crisis Standards of Care frequently overestimate
Black mortality, resulting in greater de-prioritization of Black
patients under Crisis Standards of Care.\565\ The Department solicits
comments on potential remedies to this issue and the larger topic of
racial inequities in Crisis Standards of Care.
---------------------------------------------------------------------------
\565\ See, e.g., Deepshikha C. Ashana et al., Equitably
Allocating Resources During Crises: Racial Differences in Mortality
Prediction Models, 204 a.m. J. Respir. Crit. Care Med. 178 (2021),
https://pubmed.ncbi.nlm.nih.gov/33751910/ (finding use of SOFA in
Crisis Standards of Care may lead to racial disparities in resource
allocation); Benjamin Tolchin et al., Racial Disparities in the SOFA
Score Among Patients Hospitalized with COVID-19, 16 PLoS ONE, Sept.
2021, at p. 2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8448580/
(finding non-Hispanic Black patients but not Hispanic patients had
greater odds of an elevated SOFA score when compared to non-Hispanic
white patients); Shireen Roy et al., The Potential Impact of Triage
Protocols on Racial Disparities in Clinical Outcomes Among COVID-
Positive Patients in a Large Academic Healthcare System, 16 PLoS
ONE, Sept. 2021, at p. 2, https://pubmed.ncbi.nlm.nih.gov/34529684/
(finding Black patients had higher SOFA scores compared to patients
of other races).
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Research suggests that overly relying upon any clinical algorithm,
particularly without understanding the effects of its uses, may amplify
and perpetuate racial and other biases.\566\ Accordingly, the
Department strongly cautions covered entities against overly relying
upon a clinical algorithm, for example, by replacing or substituting
the individual clinical judgment of providers with clinical
algorithms.\567\ The individual clinical judgment of a provider should
always be based on the specific needs and medical history of the
patient being treated.\568\ Covered entities that use clinical
algorithms should consider using clinical algorithms as a tool to
augment their decision-making but not as a replacement of clinical
judgment. Covered entities that overly rely upon clinical algorithms
run the risk of noncompliance with Section 1557 because such
overreliance may result in discrimination.\569\
---------------------------------------------------------------------------
\566\ See, e.g., Letter from the Am. Med. Ass'n to David Meyers,
Agency for Healthcare Research & Quality, p. 6 (May 3, 2021),
https://searchlf.ama-assn.org/letter/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2021-5-3-Letter-to-Meyers-re-AHRQ-AI-RFI-(002).pdf (in response to
AHRQ's March 5, 2021 Request for Information on Use of Clinical
Algorithms That Have the Potential to Introduce Racial/Ethnic Bias
Into Healthcare Delivery) (stating that ``it is vital that all
providers understand how the clinical algorithms they rely on to
provide appropriate and equitable care in practice are developed.
The need for such understanding is particularly acute as to how
algorithms developed using artificial intelligence are trained in
order to understand the appropriate uses for and limitations of such
algorithms. Having this understanding will help ensure appropriate
utilization of algorithms and encourage effective oversight by
regulators, providers, and others. Over-reliance on any algorithm,
particularly without an understanding of what its most effective
uses are, can create a risk for amplifying and perpetuating biases
that are present in the data, including any bias based in race or
ethnicity.'').
\567\ See, e.g., Public Comment from the Am. Acad. of Family
Physicians to the Office of Mgmt. & Budget, pp. 4-5 (June 23, 2021),
https://www.aafp.org/dam/AAFP/documents/advocacy/prevention/equality/LT-OMB-EquityRFI-062321.pdf (in response to OMB's May 5,
2021 notice on Methods and Leading Practices for Advancing Equity
and Support for Underserved Communities Through Government) (stating
that ``AI-based technology is meant to augment decisions made by the
user, not replace their clinical judgement or shared decision
making.''); Elliot Crigger & Christopher Khoury, Making Policy on
Augmented Intelligence in Health Care, 21 a.m. Med. Ass'n, J. of
Ethics 2, E188-191, Feb. 2019, at pp. 188-189, https://journalofethics.ama-assn.org/article/making-policy-augmented-intelligence-health-care/2019-02 (discussing that health care AI
should be a ``tool to augment professional clinical judgment, not a
technology to replace or override it,'' and that organizations that
implement AI systems ``should vigilantly monitor [the systems] to
identify and address adverse consequences''); see also Nat'l Ass'n
of Ins. Comm'rs, Principles on Artificial Intelligence (AI), p. 2
(2020), https://content.naic.org/sites/default/files/inline-files/AI%20principles%20as%20Adopted%20by%20the%20TF_0807.pdf (discussing
that AI actors ``should implement mechanisms and safeguards . . . to
ensure all applicable laws and regulations are followed, including
ongoing (human or otherwise) monitoring, and when appropriate, human
intervention'').
\568\ See Elliot Crigger et al., Trustworthy Augmented
Intelligence in Health Care, 46 J. Med. Sys., Jan. 2022, at p. 6,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8755670/pdf/10916_2021_Article_1790.pdf (discussing that physicians are expected
to understand the ``benefits, risks, indications, appropriateness,
and alternatives'' of using AI tools and that tools should not be
used if the physician is not able to understand enough about the
tool to use it in their practice).
\569\ See U.S. Dep't of Just., Algorithms, Artificial
Intelligence, and Disability Discrimination in Hiring (2022),
https://beta.ada.gov/ai-guidance/ (discussing how algorithms and
artificial intelligence in hiring technologies may result in
unlawful discrimination against certain groups of applicants,
including people with disabilities); U.S. Equal Emp't Opportunity
Comm'n, The Americans with Disabilities Act and the Use of Software,
Algorithms, and Artificial Intelligence to Assess Job Applicants and
Employees, EEOC-NVTA-2022-2 (2022), https://www.eeoc.gov/laws/guidance/americans-disabilities-act-and-use-software-algorithms-and-artificial-intelligence (discussing how employers' use of software
that relies on algorithmic decision-making may violate existing
requirements under Title I of the ADA).
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[[Page 47883]]
Clinical algorithmic tools are pervasive, and a covered entity may
be unaware of any discrimination that may result from their reliance on
such a tool. We note that individual providers are not likely to have
designed the clinical algorithms that augment their clinical decision-
making. However, covered entities are responsible for ensuring that any
action they take based on a clinical algorithm does not result in
discrimination prohibited by this part, irrespective of whether they
played a role in designing the algorithm.\570\ The fact that a covered
entity did not design the algorithm or does not have knowledge about
how the tool works does not alleviate their responsibility to ensure
that they do not take actions that result in discrimination. In sum,
this part does not hold covered entities liable for clinical algorithms
that they did not develop but holds entities liable under this proposed
section for the decisions they make in reliance on such algorithms.
---------------------------------------------------------------------------
\570\ See U.S. Dep't of Just., supra note 569, at pp. 2-3
(discussing how an employer's use of algorithms and artificial
intelligence in hiring technologies may still lead to unlawful
discrimination even where the employer does not mean to
discriminate); U.S. Equal Emp't Opportunity Comm'n, Americans with
Disabilities Act and the Use of Software, supra note 569, at p. 6
(discussing how an employers' use of software that relies on
algorithmic decision-making may violate existing requirements under
Title I of the ADA and that an employer may still be liable under
the ADA for its use of such tools even if the tools are designed or
administered by another entity).
---------------------------------------------------------------------------
We recognize that this is a complex and evolving area that may be
challenging for covered entities to evaluate for potential violations
of Section 1557. The Department shares a responsibility in working with
recipients, Department components, and Title I entities to identify and
prevent discrimination based upon the use of clinical decision tools
and technological innovation in health care. Covered entities should
take steps to ensure that the use of clinical algorithms does not
result in discrimination on the basis of race, color, national origin,
sex, age, or disability in their health programs and activities.\571\
For example, covered entities may choose to establish written policies
and procedures governing how information from clinical algorithms will
be used in decision-making; monitor any potential impacts; and train
staff on the proper use of such systems in decision-making.\572\
---------------------------------------------------------------------------
\571\ For information on promising practices to reduce bias and
discrimination in clinical algorithms, see generally Fed. Trade
Comm'n, Using Artificial Intelligence and Algorithms (Apr. 8, 2020),
https://www.ftc.gov/news-events/blogs/business-blog/2020/04/using-artificial-intelligence-algorithms; Fed. Trade Comm'n, Aiming for
Truth, Fairness, and Equity in Your Company's Use of AI (Apr. 19,
2021), https://www.ftc.gov/news-events/blogs/business-blog/2021/04/aiming-truth-fairness-equity-your-companys-use-ai; Fed. Trade
Comm'n, Big Data: A Tool for Inclusion or Exclusion? (Jan. 2016),
https://www.ftc.gov/system/files/documents/reports/big-data-tool-inclusion-or-exclusion-understanding-issues/160106big-data-rpt.pdf;
Nat'l Inst. of Standards & Tech., NIST Special Publ'n 1270, Towards
a Standard for Identifying and Managing Bias in Artificial
Intelligence (2022), https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.1270.pdf.; Gen. Accountability Off.,
Artificial Intelligence: An Accountability Framework for Federal
Agencies and Other Entities (2021), https://www.gao.gov/assets/gao-21-519sp.pdf; U.S. Food & Drug Admin., Good Machine Learning
Practice for Medical Device Development: Guiding Principles (Oct.
2021), https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles; U.S. Equal Emp't Opportunity Comm'n, Americans
with Disabilities Act and the Use of Software, supra note 569, at
pp. 12-14; Takshi, supra note 546, at 234-39; Robert Bartlett et
al., Algorithmic Discrimination and Input Accountability Under the
Civil Rights Acts (preprint) (2020), https://ssrn.com/abstract=3674665; Nicol Turner Lee et al., Brookings Inst.,
Algorithmic Bias Detection and Mitigation: Best Practices and
Policies to Reduce Consumer Harms (2019), https://www.brookings.edu/research/algorithmic-bias-detection-and-mitigation-best-practices-and-policies-to-reduce-consumer-harms/; Ada Lovelace Inst., AI Now
Inst. & Open Gov't P'ship, Executive Summary: Algorithmic
Accountability for the Public Sector, (2021), https://www.opengovpartnership.org/wp-content/uploads/2021/08/executive-summary-algorithmic-accountability.pdf; Ziad Obermeyer et al.,
Chicago Booth, Ctr. For Applied Artificial Intelligence, Algorithmic
Bias Playbook (2021), https://www.chicagobooth.edu/research/center-for-applied-artificial-intelligence/research/algorithmic-bias/playbook; Mei Chen & Michel Decary, Artificial Intelligence in
Healthcare: An Essential Guide for Health Leaders, 33 Healthcare
Mgmt. F. 10, (2020), https://pubmed.ncbi.nlm.nih.gov/31550922/;
Genevieve Smith & Ishita Rustagi, Berkeley Haas Ctr. for Equity,
Gender, & Leadership, Mitigating Bias in Artificial Intelligence: An
Equity Fluent Leadership Playbook (2020), https://haas.berkeley.edu/wp-content/uploads/UCB_Playbook_R10_V2_spreads2.pdf; Trishan Panch
et al., Artificial Intelligence and Algorithmic Bias: Implications
for Health Systems, 9 J. Global Health, Dec. 2019, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6875681/pdf/jogh-09-020318.pdf.
\572\ See, e.g., Takshi, supra note 546, at 234-35; Nat'l Inst.
of Standards & Tech., NIST Special Publ'n 1270, supra note 571, at
pp. 42-47; Gen. Accountability Off., supra note 571.
---------------------------------------------------------------------------
The American Medical Association (AMA) has been active in this area
and issued a framework to guide the health care community in
evaluating, integrating, using, and monitoring augmented intelligence
systems that enhance capabilities of human decision-making with
computational methods and systems (which includes clinical algorithm
tools).\573\ We recognize that ``augmented intelligence systems'' are
different in scope from clinical algorithm tools, yet believe that the
AMA research provides helpful guidance when covered entities are
considering the use of clinical algorithm tools. The AMA framework
suggests that providers should understand enough about the tools they
are using in order to evaluate, select, and implement them, and should
forgo the use of such tools if the provider does not adequately
understand how they work.\574\ Providers should also ensure that the
tool addresses a meaningful clinical goal and works as intended,
develop a clear protocol to identify and correct for potential bias,
have the ability to override the tool, ensure meaningful oversight is
in place for ongoing monitoring, and ensure clear protocols exist for
enforcement and accountability, including a clear protocol to ensure
equitable implementation.\575\ When evaluating a tool, a provider
should ask whether the tool was properly validated and validated for
the specific case and use, whether it was tested in different
populations to identify hidden bias, and whether it allows barriers to
access to be found and rectified, among other things.\576\
---------------------------------------------------------------------------
\573\ See, e.g., Crigger, Trustworthy Augmented Intelligence in
Health Care, supra note 568.
\574\ Id. at p. 6.
\575\ Id.
\576\ Id. at pp. 7-8.
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Given the increasing reliance on clinical algorithms to inform
decision-making in the area of health care, and the reality that the
implementation of these tools may be discriminatory under Section 1557,
the Department proposes Sec. 92.210 to make explicit that covered
entities are prohibited from discriminating through the use of clinical
algorithms on the basis of race, color, national origin, sex, age, or
disability under Section 1557. If OCR receives a complaint alleging
discrimination resulting from the use of a clinical algorithm in
decision-making against a covered entity, it will conduct a fact-
specific analysis of the allegation. OCR's analysis will consider,
among other things, what decisions and actions were taken by the
covered entity in reliance upon a clinical algorithm in its decision-
making, and what measures the covered entity took to ensure that its
decisions and actions resulting from using a clinical algorithm were
not discriminatory. OCR would, as required by statute and this proposed
rule, work with the covered entity to achieve voluntary
compliance.\577\
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\577\ See 42 U.S.C. 2000d-1 (enforcement action may not be taken
until the department has ``determined that compliance cannot be
secured by voluntary means''); 18116(a) (adopting the enforcement
mechanisms provided for an available under Title VI).
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[[Page 47884]]
OCR is committed to working with partners throughout the Department
and other Executive Agencies \578\ to develop responsive technical
assistance to support covered entities in complying with their civil
rights obligations. We seek comment on the inclusion of this provision;
whether it is appropriately limited to clinical algorithms or should
include additional forms of automated or augmented decision-making
tools or models, such as artificial intelligence or machine learning;
whether a provision such as this should include more specificity,
including actions covered entities should take to mitigate potential
discriminatory outcomes and what those actions should be; what
promising practices could be used by covered entities to ensure that
clinical algorithms are not discriminatory; and what type of technical
assistance or guidance would be most helpful to covered entities for
compliance with this section. We seek comment on what factors would be
relevant to determine whether a covered entity is in violation of this
provision and what possible defenses a covered entity may have when
using a clinical algorithm in its decision-making that results in
discrimination. We seek comment on governance measures, such as
transparency mechanisms, reporting requirements, and impact
assessments, that would assist in compliance with civil rights
obligations. We also seek comment on what types of clinical algorithms
are being used in covered health programs and activities; how such
algorithms are being used by covered entities; whether they are more
prevalent in certain health settings; when clinical algorithms and
variables based on protected grounds under Section 1557 are useful (or
not); and what mechanisms are in place or should be in place to detect,
address, and remediate possible discriminatory effects of their usage.
Finally, we seek comment requesting resources and recommendations on
how to identify and mitigate discrimination resulting from the usage of
clinical algorithms and other forms of automated decision-making tools
and models.
---------------------------------------------------------------------------
\578\ Many Federal agencies are taking steps to address
discrimination in clinical algorithms and artificial intelligence.
See, e.g., U.S. Dep't of Health & Human Servs., Agency for
Healthcare Research & Quality, 86 FR 12948 (Mar. 5, 2021) (Request
for Information on the Use of Clinical Algorithms That Have the
Potential to Introduce Racial/Ethnic Bias Into Healthcare Delivery);
.S. Dep't of Justice, Nat'l Inst. of Just., Predicting Recidivism:
Continuing To Improve the Bureau of Prisons' Risk Assessment Tool,
PATTERN (Apr. 19, 2022), https://nij.ojp.gov/topics/articles/predicting-recidivism-continuing-improve-bureau-prisons-risk-assessment-tool; Kristen Clarke, Assistant Att'y Gen., U.S. Dep't of
Just., Keynote Address at the Dep't. of Com.'s Nat'l Telecomm. &
Info. Admin.'s Virtual Listening Session (Dec. 14, 2021), https://www.justice.gov/opa/speech/assistant-attorney-general-kristen-clarke-delivers-keynote-ai-and-civil-rights-department; Press
Release, U.S. Equal Emp't Opportunity Comm'n, EEOC Launches
Initiative on Artificial Intelligence and Algorithmic Fairness (Oct.
28, 2021), https://www.eeoc.gov/newsroom/eeoc-launches-initiative-artificial-intelligence-and-algorithmic-fairness; Bureau of Consumer
Fin. Protection, Adverse Action Notification Requirements in
Connection with Credit Decisions Based on Complex Algorithms (May
26, 2022), https://www.consumerfinance.gov/compliance/circulars/circular-2022-03-adverse-action-notification-requirements-in-connection-with-credit-decisions-based-on-complex-algorithms/; Bd.
of Governors of the Fed. Reserve System, Bureau of Consumer Fin.
Protection, Fed. Deposit Ins. Corp., Nat'l Credit Union Admin., &
Office of the Comptroller of the Currency, 86 FR 16837 (Mar. 31,
2021) (Request for Information and Comment on Financial
Institutions' Use of Artificial Intelligence, Including Machine
Learning, Identifying Unlawful Discrimination as a Potential Risk of
Using Artificial Intelligence); Fed. Trade Comm'n, Using Artificial
Intelligence and Algorithms, supra note 571; Fed. Trade Comm'n,
Aiming for Truth, Fairness, and Equity in Your Company's Use of AI,
supra note 571; U.S. Dep't of Com., Nat'l Inst. of Standards &
Tech., supra note 571.
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Nondiscrimination in the Delivery of Health Programs and Activities
Through Telehealth Services (Sec. 92.211)
Proposed Sec. 92.211 specifically addresses nondiscrimination in
the delivery of health programs and activities through telehealth
services. Telehealth is a means by which covered entities provide their
health programs and activities, and this provision clarifies the
affirmative duty that covered entities have to not discriminate in
their delivery of such services through telehealth. This duty includes
ensuring that such services are accessible to individuals with
disabilities and provide meaningful program access to LEP individuals.
Specifically, proposed Sec. 92.211 provides that a covered entity must
not, in delivery of its health programs and activities through
telehealth services, discriminate on the basis of race, color, national
origin, sex, age, or disability. Telehealth has not been addressed in
previous Section 1557 rulemaking but has become widely used as a result
of the COVID-19 pandemic.
As defined by the Health Resources Services Administration within
the Department, telehealth means the use of electronic information and
telecommunications technologies to support long-distance clinical
health care, patient and professional health-related education, public
health, and health administration.\579\ Technologies include
videoconferencing, the internet, store-and-forward imaging, streaming
media, and terrestrial and wireless communications.\580\
---------------------------------------------------------------------------
\579\ What Is Telehealth?, U.S. Dep't of Health & Human Servs.,
Health Rsch. & Servs. Admin. (last updated Mar. 2022), https://www.hrsa.gov/rural-health/telehealth/what-is-telehealth.
\580\ What Is Telehealth? How Is It Different from
Telemedicine?, HealthIT.gov, (last updated Oct. 17, 2019), https://www.healthit.gov/faq/what-telehealth-how-telehealth-different-telemedicine.
---------------------------------------------------------------------------
Since 2016, the use of telemedicine at self-contained clinics and
the use of telehealth provided to patients at home has grown
significantly. This is particularly true of the use of telehealth at
home due to the COVID-19 pandemic, with one recent study showing a 63-
fold increase in Medicare telehealth utilization during the
pandemic.\581\ The increased availability of telehealth has been a
benefit to many, including transgender individuals who have been able
to access gender-affirming care without geographical constraints or
fear of stigma and discrimination.\582\ However, studies also indicate
disparities in access based on race and disability. One study found
``significant'' racial disparities in telehealth use during the COVID-
19 pandemic, which the authors believe may lead to the worsening of
pre-existing health disparities.\583\
---------------------------------------------------------------------------
\581\ Lok Wong Samson et al., U.S. Dep't of Health & Human
Servs., Off. of the Assistant Sec'y for Planning & Evaluation, Issue
Brief: Medicare Beneficiaries' Use of Telehealth Services in 2020:
Trends by Beneficiary Characteristics and Location (2021), https://aspe.hhs.gov/sites/default/files/documents/a1d5d810fe3433e18b192be42dbf2351/medicare-telehealth-report.pdf.
\582\ Ole-Petter R. Hamnvik et al., Telemedicine and Inequities
in Health Care Access: The Example of Transgender Health,
Transgender Health (pre-print) (2022), https://www.liebertpub.com/doi/epdf/10.1089/trgh.2020.0122.
\583\ Robert P. Pierce & James J. Stevermer, Disparities in the
Use of Telehealth at the Onset of the COVID-19 Public Health
Emergency, J. Telemed & Telecare, Oct. 21, 2020, at p. 5, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7578842/pdf/10.1177_1357633X20963893.pdf.
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One study in 2016 on telehealth among Medicare beneficiaries found
that individuals with disabilities accounted for 65 percent of
telehealth use and 66 percent of all telehealth services. Individuals
with disabilities using telehealth increased by 37.7 percent between
the years 2014 and 2016. During that same time period, individuals with
disabilities accounted for an increase of 53.7 percent of total
telehealth services used.\584\ Another more recent study looked at the
broader
[[Page 47885]]
noninstitutionalized population and found that 39.8 percent of
individuals with disabilities used telehealth during the second year of
the pandemic.\585\
---------------------------------------------------------------------------
\584\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare &
Medicaid Servs., Information on Medicare Telehealth Report (2018),
https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/Information-on-Medicare-Telehealth-Report.pdf.
\585\ Carli Friedman & Laura VanPuymbrouck, Telehealth Use by
Persons with Disabilities During the COVID-19 Pandemic, 13 Int'l J.
Telerehabilitation 2 (2021), https://doi.org/10.5195/ijt.2021.6402.
---------------------------------------------------------------------------
While there are benefits to be gained from telehealth for
individuals with disabilities, including lower cost of care and
transportation costs, lower exposure to communicable diseases, and
access to specialized care including care provided across state lines,
barriers persist around access.\586\ Some of these challenges include
inaccessible telehealth platforms and other barriers to communication
with individuals who are deaf, blind, or have cognitive
disabilities.\587\ For example, telehealth platforms have been found to
not have the ability to incorporate third-party services, including
real-time captioning and any additional video feeds that may be
required for the provision of qualified interpreters, direct service
providers, or supportive decision makers.\588\ Telehealth may also not
include considerations for usability, compatibility with external
assistive technology, and reduction on cognitive burden.\589\ Remote
patient monitoring devices used in telehealth may be challenging for
individuals with manual dexterity or physical mobility disabilities to
use.\590\ Telehealth platforms may also not be compatible with screen
reading software.\591\ Purportedly accessible mobile health (mHealth)
applications, such as applications offered by healthcare organizations
to their patients, have also been found to be inaccessible.\592\
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\586\ Thiru M. Annaswamy et al., Telemedicine Barriers and
Challenges for Persons with Disabilities: COVID-19 and Beyond, 13
Disability Health J., July 9, 2020, at p. 2, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7346769/pdf/main.pdf; Daniel
Young & Elizabeth Edwards, Telehealth and Disability: Challenges and
Opportunities for Care, Nat'l Health Educ. Law Program, (May 6,
2020), https://healthlaw.org/telehealth-and-disability-challenges-and-opportunities-for-care/.
\587\ Annaswamy, supra note 586, at p. 2; Young, supra note 586;
Rupa S. Valdez et al., Ensuring Full Participation of People with
Disabilities in an Era of Telehealth, 28 J. Am. Med. Inform. Ass'n
389 (Feb. 2021), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7717308/.
\588\ Valdez, supra note 587.
\589\ Id.; Daihua X. Yu et al., Accessibility Needs and
Challenges of a mHealth System for Patients with Dexterity
Impairments, 12 Disabil. Rehabil. Assist. Technol. 56-64 (2015),
https://doi.org/10.3109/17483107.2015.1063171; Erin Beneteau et al.,
Telehealth Experiences of Providers and Patients Who Use
Augmentative and Alternative Communication, 29 J. Am. Med. Inform.
Ass'n 481-488 (2022), https://doi.org/10.1093/jamia/ocab273.
\590\ Annaswamy, supra note 586, at p. 2.
\591\ Id.; Young, supra note 586; Valdez, supra note 587.
\592\ Keith M. Christensen & Jill Bezyak., Rocky Mountain ADA
Center, Telehealth Use Among Rural Individuals with Disabilities
(2020), https://rockymountainada.org/sites/default/files/2020-02/Rural%20Telehealth%20Rapid%20Response%20Report.pdf; Lauren R. Milne
et al., The Accessibility of Mobile Health Sensors for Blind Users,
2 J. Tech. Persons Disabilities 166-175 (2014), https://scholarworks.calstate.edu/downloads/xs55mg57v#page=173.
---------------------------------------------------------------------------
Although telehealth services are a means by which a covered entity
may provide access to a health program or activity, and thus are
clearly covered under Section 1557 and this proposed rule, the
Department has decided to also include a specific provision regarding
telehealth due to the increasing prevalence of telehealth and the
numerous related accessibility challenges. Thus, covered entities are
required to provide telehealth services in a manner that does not
discriminate on a protected basis under Section 1557, including through
the accessibility of telehealth platforms (proposed Sec. 92.204) and
by providing effective communication for individuals with disabilities
through the provision of appropriate auxiliary aids and services
(proposed Sec. 92.202) and language assistance services for LEP
individuals (proposed Sec. 92.201). Such requirements broadly apply to
all health programs and activities provided, including those via
telehealth. Such services would include communications about the
availability of telehealth services, the process for scheduling
telehealth appointments, (including the process for accessing on-demand
unscheduled telehealth calls), and the telehealth appointment itself.
OCR seeks comment on this approach and whether covered entities and
others would benefit from a specific provision addressing accessibility
in telehealth services, for individuals with disabilities and LEP
individuals. We seek comment on what such a provision should include,
and why the proposed provisions related to ICT, effective communication
for individuals with disabilities, and meaningful access for LEP
individuals are insufficient. Further, we seek comment on challenges
with accessibility specific to telehealth and recommendations for
telehealth accessibility standards that would supplement the ICT
standards (proposed Sec. 92.204) and effective communication
requirements (proposed Sec. 92.202) of this part. We encourage
commenters to consider the range of technology available for accessing
telehealth, including user-friendly design, as well as security and
privacy requirements (for example, when using public Wi-Fi access).
Subpart D--Procedures
Enforcement Mechanisms (Sec. 92.301)
Proposed Sec. 92.301 provides that the enforcement mechanisms
available for and provided under Title VI of the Civil Rights Act of
1964, Title IX of the Education Amendments of 1972, Section 504 of the
Rehabilitation Act of 1973, and the Age Discrimination Act of 1975
shall apply for purposes of Section 1557 as implemented by this part.
This is consistent with the statutory text of Section 1557, which
provides that ``[t]he enforcement mechanisms provided for and available
under such title VI, title IX, section 794, or such Age Discrimination
Act shall apply for purposes of violations of this subsection.'' \593\
Additionally, this provision is consistent with the 2016 Rule at former
Sec. 92.301(a) and Sec. 92.5(a) of the 2020 Rule. Enforcement
mechanisms include a private right of action, as recognized by the
Supreme Court in Cummings v. Premier Rehab Keller, P.L.L.C..\594\
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\593\ 42 U.S.C. 18116.
\594\ 142 S. Ct. 1562, 1569-70 (2022) (``it is `beyond dispute
that private individuals may sure to enforce' [Section 504 and
Section 1557]'').
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Notification of Views Regarding Application of Federal Conscience and
Religious Freedom Laws (Sec. 92.302)
In proposed Sec. 92.302, the Department specifically addresses the
application of Federal conscience and religious freedom laws. This is a
newly proposed provision, as neither the 2016 nor 2020 Rule provided a
specific means for recipients to notify the Department of their views
regarding the application of Federal conscience or religious freedom
laws.
Proposed paragraph (a) provides that a recipient may raise with the
Department its belief that the application of a specific provision or
provisions of this regulation as applied to it would violate Federal
conscience or religious freedom laws. Such laws include but are not
limited to the Coats-Snowe Amendment, Church Amendments, RFRA, section
1553 of the ACA, section 1303 of the ACA, and the Weldon Amendment.
Recipients are also reminded that they can file complaints regarding
Federal conscience laws with OCR, as provided in 45 CFR part 88.
Proposed paragraph (b) provides that once OCR receives a
notification pursuant to proposed paragraph (a), OCR shall promptly
consider those views in responding to any complaints
[[Page 47886]]
or otherwise determining whether to proceed with any investigation or
enforcement activity regarding that recipient's compliance with the
relevant provisions of this regulation. Any relevant ongoing
investigation or enforcement activity regarding the recipient shall be
held in abeyance until a determination has been made under paragraph
(c). Considering recipients' religious- or conscience-based concerns in
the context of an open case (i.e., when OCR first has cause to consider
the recipient's compliance), will allow OCR to make an informed, case-
by-case decision and, where applicable, protect a recipient's
conscience or religious freedom rights. Similarly, holding ongoing
investigations and enforcement activity in abeyance is designed to
alleviate the burden of a recipient having to respond to an
investigation or enforcement action until a recipient's objection has
been considered by OCR.
Proposed paragraph (c) makes clear OCR's discretion to determine at
any time whether a recipient is wholly exempt from or entitled to a
modification of the application of certain provisions of this part, or
whether modified application of the provision is required under a
Federal conscience or religious freedom law. Proposed paragraph (c)
requires that, in determining whether a recipient is exempt from the
application of the specific provision or provisions raised in its
notification, OCR must assess whether there is a sufficiently concrete
factual basis for making a determination and apply the applicable legal
standards of the referenced statute. Proposed paragraph (c) further
provides that, upon making a determination regarding whether a
particular recipient is exempt from--or subject to a modified
requirement under--a specific provision of this part, OCR will
communicate that determination to the recipient.
Proposed paragraph (d) provides that if OCR determines that a
recipient is entitled to an exemption or modification of the
application of certain provisions of this rule based on the application
of such laws, that determination does not otherwise limit the
application as to any other provision of this part to the recipient.
OCR maintains an important civil rights interest in the proper
application of Federal conscience and religious freedom protections. In
enforcing Section 1557, OCR is thus committed to complying with RFRA
and all other legal requirements. The Department believes that the
proposed approach in this section will assist the Department in
fulfilling that commitment by providing the opportunity for recipients
to raise concerns with the Department, such that the Department can
determine whether an exemption or modification of the application of
certain provisions is appropriate under the corresponding Federal
conscience or religious freedom law. As noted above, the Department
also maintains a strong interest in taking a case-by-case approach to
such determinations, which will allow it to account for any harm an
exemption could have on third parties \595\ and, in the context of
RFRA, to consider whether the application of any substantial burden on
a person's exercise of religion is in furtherance of a compelling
interest and is the least restrictive means of advancing that
compelling interest.\596\
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\595\ See Cutter v. Wilkinson, 544 U.S. 709, 720 (2005) (in
addressing religious accommodation requests, ``courts must take
adequate account of the burdens a requested accommodation may impose
on nonbeneficiaries'').
\596\ Cf. Gonzales v. O Centro Esp[iacute]rita Beneficente
Uni[atilde]o do Vegetal, 546 U.S. 418, 439 (2006) (``[C]ourts should
strike sensible balances, pursuant to a compelling interest test
that requires the Government to address the particular practice at
issue.'') (emphasis added).
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The Department seeks comment on this approach, including whether
such a provision should include additional procedural information, the
potential burdens of such a provision on recipients and potential third
parties, and additional factors that the Department should take into
account when considering the relationship between Federal conscience
and religious freedom laws and Section 1557's civil rights protections.
We also seek comment on what alternatives, if any, the Department
should consider.
Procedures for Health Programs and Activities Conducted by Recipients
and State Exchanges (Sec. 92.303)
Proposed Sec. 92.303 provides for the enforcement procedures
related to health programs and activities conducted by recipients and
State Exchanges, consistent with former Sec. 92.302 of the 2016 Rule.
The 2020 Rule does not include this provision, and instead relies on
Sec. 92.5, the general Enforcement Mechanisms section discussed above,
which includes a paragraph (b) that notes that the Director has been
delegated authority to enforce Section 1557, including the authority to
conduct investigations and compliance reviews, make enforcement
referrals to the DOJ, and take any other appropriate remedial action
the Director deems necessary.
The 2020 Rule does not make sufficiently clear for either covered
entities or individuals protected by Section 1557 what procedures will
apply in OCR's enforcement of Section 1557. As OCR has clear procedures
that apply under Title VI, Title IX, Section 504, and the Age Act, OCR
similarly needs to have clear procedures that apply under Section 1557.
Proposed paragraph (a) applies the procedural provisions in the
Title VI regulation with respect to administrative enforcement actions
concerning discrimination on the basis of race, color, national origin,
sex, and disability under Section 1557. Since the effective date of the
ACA, OCR has enforced Section 1557 according to the procedural
provisions of Title VI. The Title VI procedures have applied to
discrimination on the basis of race, color, and national origin for
decades, as well as to discrimination on the basis of sex and
disability, as the Title VI procedures have been incorporated into the
regulations implementing Title IX and Section 504.\597\ In the
Department's view, therefore, it is logical and appropriate to
similarly apply these procedures in enforcement with respect to race,
color, national origin, sex, and disability discrimination under
Section 1557.
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\597\ 45 CFR 84.61; Sec. 86.71.
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Proposed paragraph (b) applies Age Act procedures to enforce
Section 1557 with respect to age discrimination complaints against
recipients and State Exchanges. The Age Act has its own set of
procedures, and OCR has been applying those procedures in enforcement
with respect to age discrimination under Section 1557 from the
effective date of the ACA to the present.
Proposed paragraph (c) provides that when a recipient fails to
provide OCR with requested information in a timely, complete, and
accurate manner, OCR may, after attempting to reach a voluntary
resolution, find noncompliance with Section 1557 and initiate the
appropriate enforcement procedure, found at 45 CFR 80.8. This provision
was found at former Sec. 92.302(c) in the 2016 Rule. The 2020 Rule
repealed the provision, stating that when a recipient fails to provide
OCR with requested information in a timely, complete, and accurate
manner, OCR may find noncompliance with Section 1557 and initiate
appropriate enforcement procedures, absent the need to attempt to
effectuate voluntary compliance. The preamble to the 2020 Rule stated
that the existing authorities already contain parallel provisions.\598\
Yet, the preamble cites a number of provisions that do not support the
statement but rather address seeking
[[Page 47887]]
resolution through voluntary means when there is a failure to comply
with the regulation.\599\ We believe that the provision we propose at
paragraph (c) is helpful in clarifying for recipients and individuals
covered by Section 1557 that, should OCR's attempt to effectuate
voluntary compliance be unsuccessful, the consequences of failing to
provide OCR with information necessary for OCR to determine compliance
with the law may include the initiation of the appropriate enforcement
procedures, found at 45 CFR 80.8.
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\598\ 85 FR 37160, 37203 (June 19, 2020).
\599\ Id. at n. 253 (discussing 45 CFR 80.7(d) (which requires
the Department to seek resolution through informal means where there
is a failure to comply with the regulation); Sec. 80.8(c)(1) (note:
Sec. 80.8(c) does not include a paragraph (1), but Sec. 80.8(c)
requires the Department to seek voluntary compliance and take other
steps prior to taking action to terminate Federal financial
assistance); Sec. 84.6(b) (stating the right of a recipient to take
voluntary action to overcome the effects of conditions that have
resulted in limited participation by qualified individuals with
disabilities); Sec. 90.49(c) (stating that the provision of special
benefits to children or the elderly is generally presumed to be
voluntary affirmative action)).
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Procedures for Health Programs and Activities Administered by the
Department (Sec. 92.304)
Proposed Sec. 92.304 addresses procedures for all claims of
discrimination against the Department under Section 1557 or this part.
Proposed paragraph (b) makes the existing procedures under the Section
504 federally conducted regulation at 45 CFR 85.61 through 85.62
applicable to all such claims under Section 1557 for all protected
bases (i.e., race, color, national origin, sex, age, and disability).
This is the only procedure that is currently in place for any
discrimination claims against the Department under the laws that OCR
enforces. Proposed paragraph (c) requires the Department to provide OCR
access to information relevant to determining compliance with Section
1557 or this part, and proposed paragraph (d) prohibits the Department
from retaliating against an individual or entity for the purpose of
interfering with any right secured by Section 1557 or this part, or
because such individual or entity has participated in an investigation,
proceeding, or hearing under Section 1557 or this part. This is
consistent with the 2016 Rule at former Sec. 92.303.
The 2020 Rule does not include any specific provision for the
processing of claims of race, color, national origin, sex, age, or
disability discrimination against any covered Departmental program,
having rescinded former Sec. 92.303 in its entirety. The other
statutes that OCR enforces--Title VI, Title IX, and the Age Act--do not
directly apply to the Department. The 2016 Rule adopted the Section 504
procedure for all claims of discrimination against any Departmental
health program under Section 1557, a procedure that has been in place
for decades, is familiar to the Department and has worked effectively.
We believe it is important in this rule to identify the procedure that
we will use in enforcing Section 1557 with respect to Departmental
health programs and activities and therefore are proposing to do so by
reinstating the provision from the 2016 Rule at proposed paragraph (b).
The 2020 Rule also does not include the provision of the 2016 Rule
that required the Department to provide OCR access to information
necessary to determine compliance with Section 1557. The reason
provided was that ``regulations implementing Section 1557's four
underlying statutes already contain provisions addressing access to
review of covered entities' records of compliance,'' \600\ and thus the
language in the 2016 Rule to this effect was unnecessary. However,
apart from the Section 504 regulation applicable to the Department,
none of the other regulations apply to the Department; therefore,
provisions under those regulations do not apply to the Department.
Consequently, the Department is proposing to reinstate this provision
at proposed Sec. 92.304(c).
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\600\ 85 FR 37203.
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The 2020 Rule also does not include a prohibition on retaliation
that applies to the Department, which was provided at former Sec.
[thinsp]92.303(d). In repealing this provision, the preamble to the
2020 Rule stated that ``regulations implementing Section 1557's four
underlying statutes already contain provisions against intimidation and
retaliation as appropriate . . . The language in the 2016 Rule to this
effect was unnecessary.'' \601\ As we have noted, regulations
implementing three of the four underlying regulations do not apply to
the Department; therefore, we now disagree with the Department's
reasoning in 2020.
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\601\ Id.
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We are including a retaliation provision at proposed paragraph (d)
to make clear that the Department, including Federally-facilitated
Exchanges, must not intimidate, threaten, coerce, retaliate, or
otherwise discriminate against any individual or entity for the purpose
of interfering with any right or privilege secured by Section 1557 or
this part, or because such individual or entity has made a complaint,
testified, assisted, or participated in any manner in an investigation,
proceeding or hearing under Section 1557 or this part. The ADA
similarly prohibits such retaliation, interference, coercion, and
intimidation,\602\ and, as discussed supra in relation to proposed
Sec. 92.3 (relationship to other laws), the ADA and Section 504 are
generally understood to impose substantially the same requirements. The
Department is thus prohibited from engaging in retaliation,
intimidation, coercion, or interferences with rights under Section 504.
We are proposing to similarly prohibit the Department from such
discrimination under Section 1557. Further, this proposed provision
would hold the Department and Federally-facilitated Exchanges to the
same standards to which the Department holds all recipients of Federal
financial assistance.
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\602\ 42 U.S.C. 12203.
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IV. Change in Interpretation--Medicare Part B Meets the Definition of
Federal Financial Assistance
The Department's longstanding position has been that Medicare Part
B funding does not constitute Federal financial assistance for the
purpose of Title VI, Title IX, Section 504, the Age Act, and Section
1557.\603\ For the reasons discussed below, and after reevaluating the
Department's position on Medicare Part B, we are proposing to change
that position and treat Medicare Part B funds as Federal financial
assistance to the providers and suppliers subsidized by those funds.
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\603\ 81 FR 31375, 31383 (May 18, 2016).
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To constitute Federal financial assistance, the Federal funds or
assistance must confer a benefit or subsidy on the recipient;
compensation from the government for services provided to the
government is not Federal financial assistance.\604\ Further, Congress
or the department administering the funds must intend for the
assistance to subsidize the entity.\605\
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\604\ See, e.g., DeVargas v. Mason & Hanger-Silas Mason Co.,
Inc., 911 F.2d 1377, 1382 (9th Cir. 1990), cert. denied, 498 U.S.
1074 (1991); Jacobson v. Delta Airlines, 742 F.2d 1202, 1209 (9th
Cir. 1984); Hunter. v. D.C., 64 F. Supp. 3d 158, 172 (D.D.C. 2020).
\605\ U.S. Dep't of Transport. v. Paralyzed Veterans Ass'n, 477
U.S. 597, 606-07 (1986); Grove City Coll. v. Bell, 465 U.S. 555, 564
(1984).
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Building on these principles, this rule proposes to define
``Federal financial assistance,'' at proposed Sec. 92.4, in relevant
part as ``any grant, loan, credit, subsidy, contract (other than a
procurement contract but including a contract of insurance), or any
other
[[Page 47888]]
arrangement by which the Federal Government provides assistance or
otherwise makes assistance available in the form of: (i) Funds; (ii)
Services of Federal personnel; or (iii) Real and personal property or
any interest in or use of such property, including: (A) Transfers or
leases of such property for less than fair market value or for reduced
consideration; and (B) Proceeds from a subsequent transfer or lease of
such property if the Federal share of its fair market value is not
returned to the Federal Government.'' This proposed definition is
similar to the definition in HHS' regulations implementing the Title
VI, Title IX, Section 504, and the Age Act, with the exception of the
phrase ``otherwise makes assistance available.'' \606\ Similar to the
Department's definition of ``recipient'' under the implementing
regulations for Title VI, Title IX, Section 504, and the Age Act, the
Department proposes to define ``recipient'' as ``any State or its
political subdivision, or any instrumentality of a State or its
political subdivision, any public or private agency, institution, or
organization, or other entity, or any person, to whom Federal financial
assistance is extended directly or indirectly, including any subunit,
successor, assignee, or transferee of a recipient, but such term does
not include any ultimate beneficiary.'' \607\
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\606\ 45 CFR 80.13(f) (Title VI); Sec. 84.3(h) (Section 504);
Sec. 86.2(g) (Title IX); Sec. 91.4 (Age Act).
\607\ Proposed Sec. 92.4.
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In the Department's view, Medicare Part B payments constitute
Federal financial assistance and providers subsidized as a result of
those payments are recipients. The Department's long-held view that
Medicare Part A constitutes Federal financial assistance is
instructive.\608\ Like Medicare Part A, Medicare Part B is a Department
program that provides payment for health services to eligible
individuals.\609\ Eligible individuals choose to enroll in Medicare
Part B and pay a monthly fee for coverage; in exchange, the program
covers the services provided by medical providers and suppliers \610\
for the services and supplies they provide to these individuals. In
addition to fee payments made by beneficiaries, Federal funds are used
to subsidize the entities that provide Part B services. The Federal
funding benefits Part B beneficiaries by assisting them in paying for
necessary health care services; and providers, in turn, receive the
benefit of a reliable source of payment for the services provided to
eligible patients, at least some of whom may have been unable to afford
services otherwise. As in Grove City College v. Bell, discussed below,
the government is assisting providers of services by making available
to them a segment of the patient population that either (a) would not
have been able to afford any medical services, or (b) would not have
been able to afford these specific providers. In these respects, Part B
is no different than Part A because Part B is financial assistance to
providers that subsidizes their provision of health care to Part B
beneficiaries. Further, providers are recipients of these funds because
they are entities that operate health programs and activities to whom
Federal financial assistance is provided.
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\608\ 45 CFR pt. 80 app. A pt. I, No. 121 (Federal Assistance to
which these Regulations Apply; Assistance other than continuing
assistance to States; Supplementary medical insurance benefits for
the aged (Title XVIII, Part A, Social Security Act, 42 U.S.C. 1395c-
1395i-2)).
\609\ Medicare Part A also pays for hospital coverage and care
in skilled nursing facilities. Parts of Medicare, Medicare.gov,
https://www.medicare.gov/basics/get-started-with-medicare/medicare-basics/parts-of-medicare (last visited June 15, 2022). Medicare Part
B provides coverage for outpatient care by physicians and other
health care providers, lab tests, home health care, durable medical
equipment, and many preventive services. Id. See also What Medicare
Covers, Medicare.gov, https://www.medicare.gov/what-medicare-covers
(last visited June 15, 2022).
\610\ We use the term ``providers'' to refer to physician's
offices and other entities that provide Part B services, consistent
with the use of the term ``provider'' elsewhere in this rule. We
acknowledge that this term has a different meaning in the Medicare
program.
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Despite these clear similarities, the Department has previously
considered Medicare Part A to constitute Federal financial assistance,
while analyzing Part B differently. When the Department's Title VI
regulation was first published, the Department included an Appendix,
titled Federal Assistance to Which These Regulation Apply.\611\
Although the Appendix is to the Department's Title VI regulation, the
Department and courts have relied on it in determining whether
Department funds are Federal financial assistance in claims under Title
IX, Section 504, and the Age Act, as well.\612\ The Appendix contains
two lists: ``Assistance Other than Continuing Assistance to States,''
and ``Continuing Assistance to States.'' In the former list, the
Department included Medicare Part A, but not Medicare Part B.\613\ The
omission reflected the Department's position that Medicare Part B did
not constitute Federal financial assistance.\614\ Many courts have held
that Medicare Part A is Federal financial assistance for the purpose of
coverage under the Spending Clause civil rights statutes.\615\
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\611\ 45 CFR pt. 80 app. A, pt. I, No. 121.
\612\ See, e.g., Chowdury v. Reading Hosp. & Med. Ctr., 677 F.2d
317, 318-19 (3d Cir. 1982), cert. denied, 463 U.S. 1229 (1983)
(Title VI); Doe v. League Sch. of Greater Boston, Inc., No. 16-cv-
1194, 2017 WL 3594257, at *4 (D. Mass. Aug. 21, 2017) (Title IX).
\613\ 45 CFR pt. 80 app. A., pt. I, No. 121.
\614\ See 81 FR 31375, 31383 (May 18, 2016) (proposing that,
``consistent with OCR's enforcement of other civil rights
authorities, the definition of Federal financial assistance does not
include Medicare Part B'' under Section 1557). The Department
provided the following explanation in its Section 504 final rule:
``In its May 1976 Notice of Intent, the Department suggested that
the arrangement under which individual practitioners, hospitals, and
other facilities receive reimbursement for providing services to
beneficiaries under Part B of title XVIII of the Social Security Act
(Medicare) constitutes a contract of insurance or guaranty and thus
falls within the exemption from the regulation. This explanation
oversimplified the Department's view of whether Medicare Part B
constitutes Federal financial assistance. The Department's position
has consistently been that, whether or not Medicare Part B
arrangements involve a contract of insurance or guaranty, no Federal
financial assistance flows from the Department to the doctor or
other practitioner under the program, since Medicare Part B--like
other social security programs--is basically a program of payments
to direct beneficiaries.'' 45 CFR pt. 84 app. A (Analysis of Final
Regulation); 42 FR 22676, 22685 (May 4, 1977).
\615\ See, e.g., U.S. v. Baylor Univ. Med. Ctr., 736 F.2d 1039,
1042 (5th Cir. 1984), cert. denied, 469 U.S. 1189 (1985); Bernard B.
v. Blue Cross & Blue Shield, 528 F. Supp. 125, 132 (S.D.N.Y. 1981),
aff'd, 679 F.2d 7 (2d Cir. 1982); Bob Jones Univ. v. Johnson, 396 F.
Supp. 597, 603 n. 21 (D.S.C. 1974), aff'd, 529 F.2d 514 (4th
Cir.1975); Austin v Blue Cross Blue Shield of Ala., No. 4:09-cv-
1647, 2009 WL 10703738, at *1, n.1 (N.D. Ala. Oct. 16, 2009); Waris
v. HCR Manor Care, No. 07-cv-3344, 2009 WL 330990, at *19 (E.D. Pa.
Feb. 10, 2009), aff'd, on other gr., 365 Fed. App'x. 402 (3d Cir.
2021); Campen v. Portland Adventist Med. Ctr., No. 3:16-cv-00792;
2016 WL 5853736, at * 4 (D. Or. Sept. 2, 2016), adopted by 2016 WL
5858670 (D. Or. Oct. 5, 2016); Zamora-Quezada v. HealthTexas Med.
Group. of San Antonio, 34 F. Supp. 2d 433, 440 (W.D. Tex. 1998);
People by Vacco v. Mid Hudson Med. Group, P.C., 877 F. Supp. 143,
149-40 (S.D.N.Y. 1995); Glanz v Vernick, 756 F. Supp. 632, 636 (D.
Mass. 1991); Doe v. Centinela Hosp., No. 87-cv-2514 PAR, 1988 WL
81776 (C.D. Cal. June 30, 1988); Bhatt v. Uniontown Hosp., No. 83-
2455, 1986 WL 30681, at *4 (W.D. Pa. Mar. 20, 1986); U.S. v. Univ.
Hosp. of the State Univ. of N.Y. at Stony Brook, 575 F. Supp. 607,
612 (E.D.N.Y. 1983), aff'd on other gr., 729 F.2d 144 (2d Cir.
1984); U.S. v Cabrini Med. Ctr., 497 F. Supp. 95, 96 n. 1 (S.D.N.Y.
1980), rev'd on other gr., 639 F.2d 908, 910-11 (2d Cir. 1981);
NAACP v. Wilmington Med. Ctr., Inc., 453 F. Supp. 280, 329 (D. Del.
1978), Flora v. Moore, 461 F. Supp. 1104, 1115 (N.D. Miss. 1978).
Because many hospitals receive funds under Medicare and Medicaid,
many of these cases address both types of funding together. Some of
these cases refer specifically to Part A of Medicare in holding that
the funds are Federal financial assistance; others refer to Medicare
but given that the defendant is a hospital or other facility that
Part A funding covers, the funds at issue have been Part A funds.
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In explaining its position that Medicare Part B was not Federal
financial assistance in proposing the regulations implementing Section
504, the Department relied on the fact that Medicare Part B is
``provided by way of a contract,'' and thus is a contract of
[[Page 47889]]
insurance or guaranty that falls within the exception to ``Federal
financial assistance'' in Title VI.\616\ In 1977, the Department
subsequently clarified, however, that this ``explanation oversimplified
the Department's view of whether Medicare Part B constitutes Federal
financial assistance.'' \617\ In adopting this position in its final
rule implementing Section 504, the Department explained that ``its
position has consistently been that, whether or not Medicare Part B
arrangements involve a contract of insurance or guaranty, no Federal
financial assistance flows from the Department to the doctor or other
practitioner under the program, since Medicare Part B--like other
social security programs--is basically a program of payments to direct
beneficiaries.'' \618\ Given this clarification, we will focus
primarily here on the Department's 1977 rationale that no Federal
financial assistance flows from the Department to a provider under the
program.
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\616\ 41 FR 20296, 20298 (May 17, 1976) (discussing 42 U.S.C.
2000d-1, d-4).
\617\ 42 FR 22685.
\618\ Id.; 41 FR 20298.
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The Department's 1977 rationale regarding the payment to
beneficiaries no longer reflects how Medicare Part B operates. When the
Medicare Part B program was first enacted in 1965, program
beneficiaries generally paid for services out of pocket and received
partial reimbursement from the program. That is no longer the most
common method by which providers receive funds. The Medicare and
Medicaid Act (the ``Medicare Act'') currently allows physicians and
many other Part B providers and suppliers to ``accept assignment'' for
Medicare Part B claims.\619\ Providers thereby accept Medicare's
approved amount for a service and can only charge a beneficiary co-
insurance and a deductible.\620\ Providers bill the Medicare program
directly for services they provide to Part B program beneficiaries and
are paid directly by the Department.\621\
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\619\ 42 U.S.C. 1395u(h)-(i).
\620\ Lower Costs with Assignment, Medicare.gov, https://www.medicare.gov/your-medicare-costs/part-a-costs/lower-costs-with-assignment (last visited June 15, 2022).
\621\ Id.
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Significantly, at the present time, approximately two-thirds of
providers enrolled in the Medicare Part B program are ``participating
providers,'' \622\ i.e., providers that bill and are paid by the
Medicare program. Thus, the Department's primary historical rationale
for its position that Medicare Part B was not Federal financial
assistance does not reflect the current operation of the program for
the majority of providers participating in the program. Those providers
have become direct recipients of Federal financial assistance. This
significant change in facts provides ample support for the Department's
change of interpretation as applied to those providers.\623\
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\622\ Medicare Provider Enrollment Chain and Ownership System
(PECOS), https://pecos.cms.hhs.gov/pecos/login.do#headingLv1 (last
visited June 15, 2022).
\623\ See Nat'l Cable & Telecomms. Ass'n v. Brand X internet
Servs., 545 U.S. 967, 981 (2005) (``[a]n initial agency
interpretation is not instantly carved in stone. On the contrary,
the agency . . . must consider varying interpretations and the
wisdom of its policy on a continuing basis, for example, in response
to changed factual circumstances . . .'').
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Providers commonly known as ``non-participating providers'' also
provide services to Medicare beneficiaries, but they do not agree to
accept Medicare's approved amount as full payment, and can charge up to
15 percent more than Medicare's approved amount.\624\ They also receive
a lower payment rate through the program.\625\ Non-participating
providers must enroll in the Part B program for their services to be
covered by the program, but do not receive direct payment from the Part
B program.\626\ Thus, whereas they are referred to as ``non-
participating'' because they do not receive direct Medicare assignment
and are not subject to the usual participating provider fee limitations
like participating providers, non-participating providers do
participate in the Part B program overall, and enroll in the program so
that the services they provide to Part B beneficiaries will be
subsidized by the program. (In contrast, providers referred to as
``opt-out providers'' opt out of Medicare Part B entirely, and Medicare
does not pay for the services these providers provide to Part B
beneficiaries, either directly to providers themselves, or by
reimbursing Part B beneficiaries after the fact for these services.)
\627\
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\624\ 42 U.S.C. 1395w-4(g)(1); Lower Costs with Assignment,
supra note 620.
\625\ Lower Costs with Assignment, supra note 620.
\626\ 42 CFR 424.510.
\627\ Lower Costs with Assignment, supra note 620.
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Given this relationship of non-participating providers to the
Medicare Part B program, the Department believes that non-participating
providers are also recipients of Federal financial assistance under the
principles set forth by the Supreme Court in Grove City College v.
Bell, where the Court held that Federal assistance loans provided to
students to cover education-related expenses is Federal financial
assistance to educational institutions under Title IX.\628\ The Court
explained that ``[n]othing . . . [ ] suggests that Congress elevated
form over substance by making the application of the nondiscrimination
principle dependent on the manner in which a program or activity
receives Federal assistance. There is no basis in the statute for the
view that only institutions that themselves apply for Federal aid or
receive checks directly from the Federal Government are subject to
regulation.'' \629\
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\628\ Grove City Coll. v. Bell, 465 U.S. 555, 565 (1984).
\629\ Id. at 564.
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Critically, the Court noted that the Federal financial assistance
in question ``was structured to ensure that it effectively supplements
the College's own financial aid program.'' \630\ In doing so, it
rejected the argument that student loans were akin to general
assistance programs such as ``food stamps, Social Security benefits,
welfare payments, and other forms of general-purpose governmental
assistance to low-income families.'' \631\ Among the reasons the Court
cited for this rejection were the fact that ``general assistance
programs, unlike student aid programs, were not designed to assist
colleges and universities'' and that ``educational institutions have no
control over, and indeed perhaps no knowledge of, whether they
ultimately receive Federal funds made available to individuals under
general assistance programs [like Social Security], but they remain
free to opt out of Federal student assistance programs.'' \632\
Entities such as non-participating providers are aware of the flow of
Federal financial assistance to them and are permitted to opt out.
---------------------------------------------------------------------------
\630\ Id. at 565.
\631\ Id. at n.13
\632\ Id.
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In the Department's view, the rationale set forth in Grove City
College counsels in favor of considering non-participating providers
under Medicare Part B to be indirect recipients of Federal financial
assistance. Part B funds, like the Federal student aid provided to
students at issue in Grove City College, are ``designed'' to
effectively subsidize health care providers and suppliers for the
health services and supplies they provide to program beneficiaries.
Program beneficiaries who see a non-participating provider receive a
Part B payment from the program for one reason only: they have received
health services or supplies from a provider that has enrolled in the
Part B program and paid for the service out of pocket. The amount that
the provider may charge is controlled by the terms of the provider's
[[Page 47890]]
enrollment agreement in Medicare Part B. Accordingly, even though a
non-participating provider does not accept assignment, it remains a
willing participant in the Medicare Part B program and it agrees to
treat patients receiving Medicare Part B with the awareness that its
services that will be subsidized by the Department. In contrast to
general assistance programs, and similar to the student aid program at
issue in Grove City College, non-participating providers thus have
knowledge and control of whether they receive Federal funds and their
participation status, and remain free to opt out.\633\ Further, Title
VI, Section 504, Title IX, the Age Act, and this proposed rule all
require entities to sign an assurance of compliance with these laws as
a condition of receiving Federal funds.\634\ Thus both participating
and non-participating providers will have a choice as to whether to
accept the funds and comply with these civil rights laws or decline the
funds.
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\633\ Id.
\634\ 45 CFR 80.4 (Title VI); Sec. 84.5 (Section 504); Sec.
86.4 (Title IX); Sec. 91.33 (Age Act); proposed Sec. 92.5.
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Accordingly, the Department's principal 1977 rationale regarding
the flow of Federal assistance can no longer justify excluding Medicare
Part B payments from the definition of Federal financial assistance.
Participating providers are the direct recipients of Federal financial
assistance; and non-participating providers are the indirect recipients
of such assistance.
A second rationale that the Department has mentioned as potential
support for its past position that Medicare Part B is not Federal
financial assistance is that Medicare Part B is a ``contract of
insurance or guaranty.'' \635\ The Title VI statute \636\ and
regulations, and Section 504, Title IX, and Age Act regulations \637\
exclude a contract of insurance from the definition of ``Federal
financial assistance.'' Significantly, after initially relying on this
rationale, the Department clarified that its position did not depend on
this rationale.\638\ Moreover, this prior rationale does not provide a
strong basis for interpreting Medicare Part B as something other than
Federal financial assistance.
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\635\ 41 FR 20296, 20298 (May 17, 1976).
\636\ 42 U.S.C. 2000d et seq. The legislative history of Title
VI indicates that the ``contract of insurance or guaranty''
exclusion was added to the bills that became Title VI to address the
concern of some members of Congress that without the exclusion,
federally insured banks providing housing mortgages would be covered
by Title VI and be prohibited from denying mortgages based on ``the
choice of a neighbor,'' i.e., engaging in redlining, a practice now
prohibited by the Federal Fair Housing Act. 110 Cong. Rec. 1345-6
(Statement of Sen. Pastore); 110 Cong. Rec. 1497-1500 (colloquy
between Rep. Cramer, and Willard W. Wirtz, Secretary of Labor); 110
Cong. Rec. 1519 (Statement of Rep. Heller); 110 Cong. Rec. 13377-78
(June 10, 1964) (Statement of Sen. Long),110 Cong. Rec. 13435 (June
10, 1964) (Statement of Sen. Humphrey). 110 Cong. Rec. 13454-6
(Statement of Sen. Pastore); 110 Cong. Rec. 13435 (June 10, 1964)
(Statement of Sen. Humphrey). When Medicare was being enacted, some
indications in the legislative history suggest that Congress assumed
that Title VI would apply to it. See, e.g., 111 Cong. Rec. 15813
(July 7, 1965) (Statement of Sen. Hart).
\637\ 45 CFR 80.13(f) (Title VI); Sec. 84.3(h) (Section 504);
Sec. 86.2(g) (Title IX); Sec. 91.4 (Age Act).
\638\ 42 FR 22685.
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First, with respect to Section 1557 in particular, Congress made
clear in the text of the statute that a ``contract of insurance'' can
constitute Federal financial assistance, expressly declining to include
the exception from Title VI.\639\ Thus, whatever the meaning of that
exception might be in Title VI, and in the Title IX, Section 504, and
Age Act regulations, it does not apply to Section 1557.
---------------------------------------------------------------------------
\639\ 42 U.S.C. 18116(a).
---------------------------------------------------------------------------
Second, the Department now is of the view that Medicare Part B
funding is not covered by that Title VI exception, because it is not a
``contract of insurance or guaranty.'' It is instructive, in this
regard, to consider how the Department has analyzed Medicare Part A
with respect to the question of what constitutes Federal financial
assistance. Medicare Part A and Part B are fundamentally similar in
many respects. Both are Federal programs providing health-related
coverage to eligible individuals. In both, providers agree to meet
conditions of participation or coverage in exchange for receiving
payments for their services to eligible enrolled individuals. In both,
payments come from a Federal trust fund. In both, the services covered,
fees paid, and other aspects of the program are governed by a variety
of statutes and regulations. That participation in Part B is voluntary
for eligible individuals does not make Part B funds a ``contract of
insurance or guaranty,'' particularly since some individuals who do not
qualify for ``premium-free'' Part A coverage can ``buy-in'' to Medicare
Part A.\640\ Part A buy-in has been a feature of Medicare since 1972,
though the statute has subsequently been amended to expand eligibility
for this option.\641\ Both Parts contain the word ``insurance'' in
their Titles; \642\ yet Medicare Part A has always been considered
Federal financial assistance by the Department, notwithstanding this
denomination. Thus, the use of this term in Part B has no more
significance than it does in Part A. In both programs, insurance
companies serve as Medicare Administrative Contractors, processing
claims and paying providers \643\ as agents of the Department, not as
insurers of individuals. We note as well that most of the funding for
the Part B fund comes from Federal and State tax revenue and interest
on investments, not ``premium'' payments.\644\
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\640\ Part A Costs, Medicare.gov, https://www.medicare.gov/your-medicare-costs/part-a-costs (last visited June 15, 2022).
\641\ Public Law 92-603, 202, 86 Stat. 1329 (Oct. 30, 1972), as
amended by, The Omnibus Budget Reconciliation Act of 1989, Public
Law 101-239, 6013, 103 Stat. 2106 (Dec. 19, 1989).
\642\ 42 U.S.C. ch. 7, subch. XVIII, pt. A (Hospital Insurance
Benefits for Aged and Disabled); 42 U.S.C. ch. 7, subch. XVIII, pt.
B (Supplementary Insurance Benefits for Aged and Disabled).
\643\ 42 U.S.C. 1395kk-1; Medicare Administrative Contractors,
Ctrs. for Medicare & Medicaid Servs., https://www.cms.gov/Medicare/Medicare-Contracting/Medicare-Administrative-Contractors/MedicareAdministrativeContractors (last visited June 15, 2022).
\644\ Tax Policy Ctr., Tax Policy Center Briefing Book: Key
Elements of the U.S. Tax System, https://www.taxpolicycenter.org/briefing-book/what-medicare-trust-fund-and-how-it-financed (last
visited June 15, 2022) (indicating SMI trust fund received over 70%
of its 2017 year assets from general revenue, including individual
income taxes, corporate taxes, and excise taxes).
---------------------------------------------------------------------------
The Department seeks comment on the impact that this proposed
change may have on recipients subsidized only by Medicare Part B funds
and no other sources of Federal financial assistance from the
Department. We also seek comment on the time that should be allowed for
recipients of Part B funds to come into compliance with the applicable
statutes and their implementing regulations and what resources the
Department can provide to assist newly covered entities in coming into
compliance.
V. CMS Amendments
The 2020 Rule amended ten provisions in CMS regulations, at least
some of which cover entities that are also subject to Section 1557, to
delete language that prohibited discrimination on the basis of sexual
orientation and gender identity.\645\ These provisions included
regulations governing
[[Page 47891]]
Medicaid and CHIP; \646\ PACE; \647\ health insurance issuers including
issuers providing essential health benefits (EHB) and issuers of
qualified health plans (QHPs), and their officials, employees, agents,
and representatives; States and the Exchanges carrying out Exchange
requirements; and agents, brokers, or web-brokers that assist with or
facilitate enrollment of qualified individuals, qualified employers, or
qualified employees.\648\ The 2020 Rule stated that in light of the
overarching applicability of Section 1557 to these programs and
entities, the Department was making these amendments to ensure greater
consistency in civil rights enforcement across the Department's
different programs.\649\ See supra section II.B. for additional detail.
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\645\ See 85 FR 37160, 37162 (June 19, 2020) (the provisions
that were amended included: Medicaid and CHIP (42 CFR 438.3(d)(4),
Sec. 438.206(c)(2), Sec. 440.262); PACE (42 CFR 460.98(b)(3),
Sec. 460.112(a)); issuers offering coverage in the group and
individual markets (45 CFR 147.104(e)); Exchange-related programs
(45 CFR 155.120(c)(1)(ii), Sec. 155.220(j)(2)(i), Sec. 156.200(e),
Sec. 156.1230(b)(2)). 45 CFR 147.104 applies not only to issuers
subject to Section 1557, but to all health insurance issuers
offering non-grandfathered individual, small group, and large group
health insurance, and Sec. 156.125(b) applies not only to issuers
subject to Section 1557, but to all health insurance issuers
offering non-grandfathered individual and small group health
insurance.
\646\ The 2020 Rule, at 85 FR 37221, removed references to
sexual orientation and gender identity as a prohibited basis of
discrimination from 42 CFR 438.3(d)(4), Sec. 438.206(c)(2), and
Sec. 440.262.
\647\ The 2020 Rule, at 85 FR 37220-21, removed references to
sexual orientation from 42 CFR 460.98(b)(3) and Sec. 460.112(a).
However due to a publishing error, the text of Sec. 460.112(a)
still states that PACE participants have the right not to be
discriminated against on the basis of sexual orientation.
\648\ The 2020 Rule, at 85 FR 37221, removed references to
sexual orientation and gender identity as a prohibited basis of
discrimination from 45 CFR 147.104(e), Sec. 155.120(c)(1)(ii),
Sec. 155.220(j)(2)(i), Sec. 156.200(e), and Sec. 156.1230(b)(2).
\649\ 85 FR 37162.
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The Department is committed to ensuring that all persons should be
able to access health care without being subjected to sex
discrimination, and that all persons should receive equal treatment
under the law, no matter their gender identity or sexual orientation.
Accordingly, in this proposed rule, the Department proposes to amend
these CMS regulations \650\ so that they again identify and recognize
discrimination on the basis of sexual orientation and gender identity
as prohibited forms of discrimination based on sex. In addition, the
Department proposes to amend a regulation applying these protections in
CHIP to also apply to Medicaid fee-for-service programs and managed
care programs. These proposals are consistent with those elsewhere in
this proposed rule and would ensure that sexual orientation and gender
identity are added and promote consistency across HHS programs of
policies and requirements that prohibit discrimination based on sexual
orientation or gender identity. In the ``Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for
2023'' published in the Federal Register on January 5, 2022 (2023
Payment Notice proposed rule),\651\ HHS proposed similar amendments to
some of those same regulations applicable to Exchanges, QHPs, and
certain issuers to prohibit discrimination based on sexual orientation
and gender identity.\652\ These provisions were not finalized in the
Final Rule published on May 6, 2022.\653\ Commenters that provided
comments on the 2023 Payment Notice proposed rule should not submit
duplicative comments to this proposed rule as the Department will
consider all comments previously submitted regarding these proposals in
issuing its final rule.
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\650\ See 85 FR 37162 (the provisions that were amended
included: Medicaid and CHIP (42 CFR 438.3(d)(4), Sec.
438.206(c)(2), Sec. 440.262); PACE (42 CFR 460.98(b)(3), Sec.
460.112(a)); issuers offering coverage in the group and individual
markets (45 CFR 147.104(e)); Exchange-related programs (45 CFR
155.120(c)(1)(ii), Sec. 155.220(j)(2)(i), Sec. 156.200(e), Sec.
156.1230(b)(2)).
\651\ 87 FR 584 (Jan. 5, 2022).
\652\ 45 CFR 147.104(e); Sec. 155.120(c)(1)(ii); Sec.
155.220(j)(2)(i); Sec. 156.200(e); Sec. 156.1230(b)(2).
\653\ 87 FR 27208, 27209 (May 6, 2022).
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Prohibiting sex discrimination based on sexual orientation and
gender identity can lead to improved health outcomes for members of the
LGBTQI+ community. Without such protection, individuals will likely
continue facing barriers to accessing medically necessary health care.
For example, without protection from discrimination, transgender
individuals may face barriers or be denied clinically appropriate
gender-affirming care.
On June 15, 2020, the U.S. Supreme Court held that Title VII's
prohibition on employment discrimination based on sex encompasses
discrimination based on sexual orientation and gender identity.\654\
The Bostock majority concluded that the plain meaning of ``because of
sex'' in Title VII necessarily included discrimination because of
sexual orientation and gender identity.\655\ Subsequently, DOJ's Civil
Rights Division issued a memorandum \656\ concluding that the Supreme
Court's reasoning in Bostock applies to Title IX. As made clear by the
ACA, Section 1557 prohibits discrimination ``on the ground prohibited
under . . . Title IX.'' \657\
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\654\ Bostock v. Clayton Cnty., 140 S. Ct. 1731 (2020).
\655\ Id. at 1753-54.
\656\ Karlan Memo, supra note 46.
\657\ 42 U.S.C. 18116(a).
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Consistent with Bostock, HHS OCR issued its Bostock Notification,
interpreting Section 1557's prohibition on discrimination on the basis
of sex to include discrimination on the basis of sexual orientation and
gender identity. Based on this and the statutory authorities identified
below, the Department also relies on Section 1557 as authority for the
proposed amendments to 45 CFR 155.120, 155.220, 156.200, and 156.1230
as well as 42 CFR 438.3(d)(4), 42 CFR 438.206(c)(2), and 42 CFR 440.262
in this proposed rule. CMS is also proposing a parallel amendment to 45
CFR 147.104 that would prohibit discrimination on the basis of sex
(including on the basis of sexual orientation or gender identity)
consistent with the Section 1557 implementing regulations proposed in
this rule but is relying on the separate authorities identified later
in this discussion. We are also including a discussion at 45 CFR
156.125 that clarifies how the proposed change to 45 CFR 156.200 would
impact the nondiscrimination requirements for plans providing EHB such
that plans subject to EHB requirements would be prohibited from
discriminating on the basis of sex (including sexual orientation or
gender identity) relying on separate authorities identified below.
Subpart B of this NPRM discusses the Section 1557's prohibition on
discrimination on the basis of sex (including pregnancy, sex
characteristics, sexual orientation, and gender identity). This portion
of the preamble focuses on the CMS freestanding, independent provisions
that have long provided for nondiscrimination on the basis of sex in
its programs and services. While the Section 1557 NPRM proposes to
include sex stereotypes, sex characteristics, pregnancy or related
conditions, sexual orientation, and gender identity as enumerated forms
of sex discrimination, CMS limits the explicit mention to gender
identity and sexual orientation, while understanding that
discrimination on the basis of sex stereotypes, sex characteristics,
and pregnancy or related conditions is prohibited sex discrimination.
We seek comment on this approach for all of the CMS provisions
addressed in this section.
A. Medicaid and Children's Health Insurance Program (CHIP)
In the Medicaid and CHIP managed care final rule published in the
Federal Register on May 6, 2016,\658\ CMS explicitly included
prohibitions on discrimination based on sexual orientation or gender
identity. In that rulemaking, CMS explained that adopting protections
against discrimination on these bases was necessary to assure that care
and services are provided in a manner consistent with the best interest
of beneficiaries under section 1902(a)(19)
[[Page 47892]]
of the Social Security Act (``the SSA'') and relied on authority under
section 1902(a)(4) of the SSA to adopt regulatory antidiscrimination
protections and obligations for managed care plans.\659\ We amended 42
CFR 438.3(d)(4), which prohibits enrollment discrimination in contracts
with managed care organizations, prepaid inpatient health plans,
prepaid ambulatory health plans, primary care case managers, and
primary care case management entities, as well as 42 CFR 438.206(c)(2),
which, as amended, required each managed care organization, prepaid
inpatient health plan, and prepaid ambulatory health plan to
participate in a ``State's efforts to promote the delivery of services
in a culturally competent manner to all enrollees, . . . regardless of
gender, sexual orientation or gender identity.'' We also explained that
the obligation for the state plan to promote access and delivery of
services without discrimination was necessary to assure that care and
services were provided in a manner consistent with the best interest of
beneficiaries under section 1902(a)(19) of the SSA.\660\ Therefore, in
the Medicaid and CHIP managed care 2016 final rule, we created a new
provision entitled ``Access and cultural considerations'' at 42 CFR
440.262, requiring states to have methods to ``promote access and
delivery of services in a culturally competent manner to all
beneficiaries, including those with limited English proficiency,
diverse cultural and ethnic backgrounds, disabilities, and regardless
of gender, sexual orientation or gender identity.'' In addition, 42 CFR
438.3(f) (which is also applicable to CHIP managed care entities per
Sec. 457.1201(f)), requires compliance with all applicable Federal and
State laws and regulations, including Section 1557. The
antidiscrimination provision in Sec. 438.3(d)(4) also applied to CHIP
managed care entities under Sec. 457.1201(d); those CHIP managed care
regulations apply the terms of the Medicaid managed care regulations
through existing cross-references. As explained in the Medicaid and
CHIP managed care 2016 final rule, CMS believes it is appropriate to
align the requirements for managed care programs in the Medicaid and
CHIP contexts, including with regard to beneficiary protections and
access to services.\661\
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\658\ 81 FR 27498 (May 6, 2016).
\659\ 80 FR 31097, 31147-48 (June 1, 2015); 81 FR 27538-39,
27666.
\660\ 81 FR 27666.
\661\ 80 FR 31169-71, 31173; 81 FR 27757-58, 27765.
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Due to an oversight, the Medicaid and CHIP managed care 2016 final
rule did not apply the provisions requiring nondiscrimination as
described in 42 CFR 440.262 to fee-for-service CHIP programs. In the
Department's view, providing access to services in a non-discriminatory
manner is in the best interest of all CHIP beneficiaries. CMS therefore
now proposes to rectify that omission by incorporating 42 CFR 440.262
into CHIP regulations through a cross-reference at 42 CFR 457.495(e).
Taken together, these protections further the purpose of CHIP to
provide child health assistance in an effective and efficient manner
that is consistent with section 2101(a) of the SSA.
CMS now proposes, based on Section 1557 as discussed previously,
and its separate statutory authority under sections 1902(a)(4) of the
SSA (codified at 42 U.S.C. 1396a(a)(4)) and 2101(a) of the SSA
(codified at 42 U.S.C. 1397aa(a)), to amend 42 CFR 438.3(d)(4), 42 CFR
438.206(c)(2), and 42 CFR 440.262 to again prohibit Medicaid and CHIP
managed care organizations, prepaid inpatient health plans, prepaid
ambulatory health plans, primary care case managers, and primary care
case management entities in managed care programs from discriminating
on the basis of sexual orientation and gender identity, and to require
managed care plans and State fee-for-service Medicaid and CHIP programs
to promote access and delivery of services in a culturally competent
manner to all beneficiaries, including those with limited English
proficiency, diverse cultural and ethnic backgrounds, disabilities, and
regardless of gender, sexual orientation or gender identity. As noted
above, the managed care contracting and service delivery provisions
would also apply to CHIP managed care entities based on existing
regulations, creating an alignment in the Medicaid and CHIP managed
care requirements.
As HHS noted in its 2016 Medicaid CHIP managed care final
rule,\662\ CMS possesses statutory authority to amend 42 CFR
438.3(d)(4), 42 CFR 438.206(c)(2), and 42 CFR 440.262 under section
1902(a)(4) of the SSA, which authorizes the Secretary to adopt methods
of administration necessary for the proper and efficient operation of
the Medicaid state plan; section 1902(a)(19) of the SSA (codified at 42
U.S.C. 1396a(a)(19)), which requires the Medicaid state plan to provide
safeguards as necessary to assure that covered services are provided in
a manner consistent with the best interests of the recipients; and
section 2101(a) of the SSA (codified at 42 U.S.C. 1397aa(a)), which
permits provision of funds to States to enable them to initiate and
expand the provision of child health assistance to uninsured, low-
income children in an effective and efficient manner. CMS interprets
section 1902(a)(19) of the SSA as prohibiting discrimination in the
delivery of services because such discrimination is inconsistent with
the best interests of the Medicaid beneficiaries who are eligible for
and receive services. CMS interprets sections 1902(a)(4) and 2101(a) of
the SSA as authorizing CMS to adopt regulations prohibiting
discrimination on the basis of gender identity or sexual orientation
because such prohibitions on discrimination are necessary for the
proper and efficient operation of a state plan, are in the best
interest of beneficiaries, and enable states to provide child health
assistance in an effective and efficient manner. Adopting regulations
to ensure that eligible beneficiaries receive services under these
programs is consistent with the purpose of the Medicaid and CHIP
programs to furnish and expand access to medical assistance. The
proposed amendments to 42 CFR 438.3(d)(4), 438.206(c)(2), 440.262, and
457.495(e) would explicitly prohibit discrimination on the basis of
sexual orientation and gender identity in addition to the existing
prohibitions imposed on Medicaid and CHIP under Section 1557.
Importantly, adopting a broader interpretation of what is necessary and
appropriate to ensure proper and efficient Medicaid and CHIP programs
and to ensure services are delivered in a manner that is in the best
interest of the beneficiary is warranted in light of the existing
trends in health care discrimination \663\ and to better address
barriers to health equity. Section II.D. of this NPRM includes an
extensive discussion of LGBTQI+ health disparities. These CMS
conforming amendments, in addition to the broad prohibition on
discrimination required under Section 1557, allow CMS to ensure that
its programs and services are operated without discrimination and would
help address those disparities. While we are restoring 42 CFR
438.3(d)(4), 438.206(c)(2), 440.262, and adding 457.495(e), as part of
using our longstanding program authority, Section 1557 requires
nondiscrimination in these programs and services.
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\662\ 81 FR 27498.
\663\ Thu T. Nguyen et al., Trends for Reported Discrimination
in Health Care in a National Sample of Older Adults with Chronic
Conditions, 33 J. Gen. Intern. Med. 291 (2018), https://doi.org/10.1007/s11606-017-4209-5.
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[[Page 47893]]
Section 1557 prohibits discrimination on the basis of sex,
importantly including sexual orientation and gender identity. CMS is
proposing to amend 42 CFR 440.262 to restore the explicit prohibition
against discrimination in the delivery of services on the basis of
sexual orientation and gender identity. We also propose to replace
``gender'' with ``sex'' and add ``(including sexual orientation and
gender identity)'' for consistency with the proposals elsewhere in this
proposed rule, to ensure that sexual orientation and gender identity
are added, and to promote consistency across HHS programs. As adopted
in 2016, the regulation at 42 CFR 440.262 was described by CMS as an
obligation for the state Medicaid plan to promote access and delivery
of services without discrimination \664\ and the proposal here
reiterates the meaning and scope for this regulation. By reinstating
the explicit references to sexual orientation and gender identity as
forms of sex discrimination, this proposal would amend 42 CFR 440.262
to protect individuals from discrimination on those bases in the same
way that discrimination on the basis of limited English proficiency,
disabilities, and cultural and ethnic backgrounds is prohibited. We
also propose to change ``unique needs'' in 42 CFR 440.262 to
``individualized needs'' to more accurately reflect Medicaid's goal of
providing person-centered care. As adopted in 2016, the regulation at
42 CFR 438.206(c)(2) required Medicaid managed care plans to
participate in the State efforts to promote the delivery of services in
a manner required by 42 CFR 440.262,\665\ so CMS is proposing to amend
42 CFR 438.206(c)(2) to reinstate the references to sexual orientation
and gender identity to align the Medicaid managed care regulation with
the proposal to amend 42 C.F.R 440.262. Similarly, CMS is proposing to
reinstate references to sexual orientation and gender identity in the
Medicaid managed care regulation at 42 CFR 438.3(d)(4) that prohibits
Medicaid managed care plans from discriminating against individuals
eligible to enroll and from using any policy or practice that has the
effect of discriminating on the basis of listed characteristics, which
currently include race, color, national origin, sex, or disability. For
consistency with the proposals elsewhere in this proposed rule to
ensure that sexual orientation and gender identity are added and
promote consistency across HHS programs for how protections against
discrimination on the basis of sexual orientation or gender identify
are reflected in regulation, we propose to revise the term ``sex'' in
the current regulation text to ``sex (including sexual orientation and
gender identity)'' at 42 CFR 438.206(c)(2) and 42 CFR 438.3(d)(4).
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\664\ 81 FR 27666.
\665\ Id.
---------------------------------------------------------------------------
CMS also proposes to add a similar nondiscrimination provision for
CHIP, to apply to fee-for-service and managed care delivery systems, by
incorporating 42 CFR 440.262 into CHIP regulations through a cross-
reference at 42 CFR 457.495(e). Because of existing cross-references in
42 CFR 457.1201(d) and 457.1230(a), the amendments to the Medicaid
managed care regulations at 42 CFR 438.3(d)(4) and 438.206(c)(2) would
also apply to CHIP managed care entities.
Finally, the Department proposes that if any of the provisions at
CFR 457.495(e), 42 CFR 440.262, 42 CFR 438.206(c)(2) and 42 CFR
438.3(d)(4) is held to be invalid or unenforceable by its terms, or as
applied to any person or circumstance, it shall be severable from its
respective sections and shall not affect the remainder thereof or the
application of the provision to other persons not similarly situated or
to other dissimilar circumstances. In enforcing the nondiscrimination
provisions in these CMS regulations, HHS will comply with laws
protecting the exercise of conscience and religion, including RFRA and
all other applicable legal requirements.
B. Programs of All-Inclusive Care for the Elderly (PACE)
CMS issued an interim final rule implementing the Programs of All-
Inclusive Care for the Elderly (PACE) on November 24, 1999.\666\ In
response to comments received on the November 24, 1999 interim final
rule, in a December 8, 2006 Final Rule,\667\ CMS added references to
``sexual orientation'' to several PACE regulations intended to prevent
discrimination against PACE participants, consistent with CMS'
authority under sections 1894(f) and 1934(f) of the SSA. Specifically,
CMS amended 42 CFR 460.98(b)(3) to prohibit PACE organizations from
discriminating against any participant in the delivery of required PACE
services based on sexual orientation, among other bases. Similarly, CMS
modified Sec. 460.112(a) to affirmatively state that each PACE
participant has the right not to be discriminated against in the
delivery of required PACE services based on sexual orientation, among
other bases.
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\666\ 64 FR 66234 (Nov. 24, 1999).
\667\ 71 FR 71244 (Dec. 8, 2006).
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Congress authorized PACE under both Medicare and Medicaid, in
sections 1894 and 1934 of the SSA, codified at 42 U.S.C. 1395eee and 42
U.S.C. 1396u-4, respectively. For a description of the relevant
legislative history, we direct readers to the December 8, 2006 Medicare
and Medicaid Programs; Programs of All-Inclusive Care for the Elderly
(PACE); Program Revisions final rule.\668\ Sections 1894(f) and 1934(f)
of the SSA set forth the requirements for issuing regulations to carry
out sections 1894 and 1934. Sections 1894(f)(2) and (3) and 1934(f)(2)
and (3) include certain provisions relating to beneficiary and program
protections under PACE. Sections 1894(f)(4) and 1934(f)(4) however,
provide in identical terms that ``[n]othing in this subsection shall be
construed as preventing the Secretary from including in regulations
provisions to ensure the health and safety of individuals enrolled in a
PACE program under this section that are in addition to those otherwise
provided under paragraphs (2) and (3).'' This authority allows CMS to
implement regulations to provide additional protections to ensure the
health and safety of PACE participants in addition to those specified
in sections 1894(f)(2) and (3) and 1934(f)(2) and (3).
---------------------------------------------------------------------------
\668\ Id.
---------------------------------------------------------------------------
PACE participants are some of CMS's most vulnerable and frail
beneficiaries, with the vast majority dually eligible for both Medicare
and Medicaid. To be eligible to enroll in a PACE program an individual
must be determined to need the level of care required under the state
Medicaid plan for coverage of nursing facility services.\669\ One of
the purposes of the PACE program is to enable PACE participants to live
in the community with the support of PACE services as long as medically
and socially feasible, instead of residing in a nursing facility or
other institutional setting.\670\ While PACE participants receive care
in a wide range of settings, including the PACE center, the home, and
inpatient facilities, given the general characteristics of the PACE
population, PACE organization staff interact with PACE participants in
much the same way that nursing facility staff work with long-term care
residents who are not PACE participants. Given the role of the PACE
organization and the frequent interactions between PACE staff and PACE
participants, the need to ensure
[[Page 47894]]
discrimination does not occur is even greater.
---------------------------------------------------------------------------
\669\ 42 CFR 460.150(b)(2).
\670\ Id. at Sec. 460.4(b)(3).
---------------------------------------------------------------------------
As addressed above, CMS now proposes, using its authority under
section 1557 of the ACA and its authorities under sections 1894(f)(4)
and 1934(f)(4) of the SSA, to amend PACE regulations at 42 CFR
460.98(b)(3) and 460.112(a) to explicitly prohibit discrimination on
the basis of sexual orientation or gender identity.
Revised Sec. 460.98(b)(3) would state that PACE organizations may
not discriminate against any participant in the delivery of required
PACE services based on race, ethnicity, national origin, religion, sex
(including sexual orientation and gender identity), age, mental or
physical disability, or source of payment. Similarly, we are proposing
to revise 42 CFR 460.112(a) to add references to ``sexual orientation''
and ``gender identity'' to establish a right for each PACE participant
not to be discriminated against in the delivery of required PACE
services on the basis of sexual orientation or gender identity. Revised
Sec. 460.112(a) will provide in relevant part that each PACE
participant has the right not to be discriminated against in the
delivery of required PACE services based on race, ethnicity, national
origin, religion, sex (including sexual orientation and gender
identity), age, mental or physical disability, or source of payment.
In addition, in the proposed rule, ``Patient Protection and
Affordable Care Act; HHS Notice of Benefit and Payment Parameters for
2023'' published in the Federal Register on January 5, 2022 (2023
Payment Notice proposed rule),\671\ HHS proposed to amend certain
regulations applicable to Exchanges, qualified health plans (QHPs), and
certain issuers to prohibit discrimination based on sexual orientation
and gender identity.\672\ That proposed rule discussed that LGBTQI+
individuals face pervasive health and health care disparities,\673\ and
are at higher risk for many concomitant conditions and that overall,
LGBTQI+ people report being in poorer health than non-LGBTQI+
individuals.\674\ The 2015 report, LGBT Older Adults in Long-Term Care
Facilities, found that elders in this community are more likely to be
single, childless, estranged from their biological family, and reliant
on families of choice, such as friends and other loved ones, for
informal support.\675\ Available research indicates that nursing home
staff may be unfamiliar with the challenges and stigma faced by the
LGBTQI community.\676\ Many of these nursing facilities studied also
failed to have care plans in place that ensured the safety of their
LGBTQ residents and lacked a meaningful appreciation for their specific
history.\677\ One survey of nursing home social workers suggested that
more than half of nursing home staff were ``either intolerant of
homosexuality . . . or openly negative and condemnatory.'' \678\
Research suggests that nursing home staff may also fail to provide
equal care to the LGBTQI+ community. For instance, research has shown
that nursing home staff sometimes fail to provide basic care such as
bathing, toileting, and feeding for LGBTQI+ residents at higher rates
than for residents who are not, because of staff refusal to touch
LGBTQI+ residents.\679\
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\671\ 87 FR 584 (Jan. 5, 2022).
\672\ As discussed infra section V.C., the Department did not
finalize these provisions in the Payment Notice final rule (87 FR
27208, 27209 (May 6, 2022)) because this proposed rule addressing
Section 1557 also would address issues related to prohibited
discrimination based on sex. Therefore, the Department determined
that it would be most prudent to address the nondiscrimination
proposals related to sexual orientation and gender identity in this
Section 1557 proposed rule to ensure consistency across the policies
and requirements applicable to entities subject to Section 1557.
\673\ See, e.g., Lesbian, Gay, Bisexual, and Transgender Health,
Healthy People 2020, HealthyPeople.gov, https://www.healthypeople.gov/2020/topics-objectives/topic/lesbian-gay-bisexual-and-transgender-health (last visited June 15, 2022);
Hudaisa Hafeez et al., Healthcare Disparities Among Lesbian, Gay,
Bisexual, and Transgender Youth: A Literature Review, 9 Cureus e1184
(2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478215/; Karen
I. Fredriksen-Goldsen et al., Health Disparities Among Lesbian, Gay,
and Bisexual Older Adults: Results from a Population-Based Study,
103 A.m. J. Pub. Health 1802 (2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3770805/; Billy A. Caceres et al., A Systematic
Review of Cardiovascular Disease in Sexual Minorities, 107 A.m. J.
Public Health e13-e21 (2017), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5343694/.
\674\ Daniel, supra note 119.
\675\ Nat'l Senior Citizens Law Center et al., LGBT Older Adults
in Long-Term Care Facilities (last updated 2015), https://www.lgbtagingcenter.org/resources/pdfs/NSCLC_LGBT_report.pdf.
\676\ Alan Moses, A Second ``Closet'' for Some LGBTQ Seniors
Entering Nursing Homes, U.S. News (Aug. 10, 2021), https://www.usnews.com/news/health-news/articles/2021-08-10/a-second-closet-for-some-lgbtq-seniors-entering-nursing-homes.
\677\ Id.
\678\ David Henry Wolfenson, The Risks to LGBT Elders in Nursing
Homes and Assisted Living Facilities and Possible Solutions, 26 Tul.
J. L. & Sexuality 123 (2017), https://journals.tulane.edu/tjls/article/view/3020/2812.
\679\ Id.
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As described earlier in this section, the functions filled by PACE
organization staff are often similar to those filled by nursing home
staff (e.g., bathing, toileting, and feeding). Since the functions are
similar, PACE organizations would typically employ people with the same
training and education as nursing home staff. Therefore, it is
reasonable to assume that nursing home staff and PACE staff might treat
individuals in much the same way. In fact, since PACE staff are
generally required to have one year of experience working with the
frail or elderly population,\680\ which is similar to the population
with which nursing home staff work, it is also reasonable to assume
that nursing home staff might transfer to a PACE organization. As a
result, we believe that PACE participants, regardless of the care
setting, may encounter the same or similar issues as nursing home
residents when receiving services from the PACE organization.
---------------------------------------------------------------------------
\680\ See 42 CFR 460.64(a)(3).
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As explained earlier in this section of this proposed rule,
research on nursing home care indicates that LGBTQI+ individuals often
do not receive the health care needed to maintain and improve their
overall health status. Since PACE participants have similarities to
nursing home residents, we believe many of the same nursing home
concerns might affect the provision of the benefits PACE organizations
are required to provide under Sec. 460.92(a). As discussed supra
section II.B., LGBTQI+ individuals experience high rates of health
disparities.
The PACE benefit package for all participants, regardless of the
source of payment, must include all Medicare-covered services; all
Medicaid-covered services, as specified in the State's approved
Medicaid plan; and other services determined necessary by the
participant's interdisciplinary team (IDT) to improve and maintain the
participant's overall health status.\681\ Decisions by the IDT to
provide or deny services must be based on an evaluation of the
participant's current medical, physical, emotional and social needs and
current clinical practice guidelines and professional standards of care
applicable to the particular service.\682\ Furthermore, the IDT must
perform an initial in-person comprehensive assessment of each
participant.\683\ This includes evaluating the physical and cognitive
function and ability of each participant, the participant's and
caregiver's preferences for care, socialization and availability of
family support, current health status and treatment needs, and other
factors. These requirements are intended to ensure that the IDT makes
decisions based on the unique needs of each
[[Page 47895]]
PACE participant. Discriminatory decision-making is inconsistent with
these overall standards for how PACE organizations must furnish
services.
---------------------------------------------------------------------------
\681\ Id. at Sec. 460.92(a).
\682\ Id. at Sec. 460.92(b).
\683\ Id. at Sec. 460.104(a).
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We believe that expressly prohibiting discrimination based on
sexual orientation or gender identity in these regulations could lead
to improved health outcomes for PACE participants.\684\ Without robust
protection from such discrimination, PACE participants may face, or
continue to face, barriers to accessing medically necessary health
care, and PACE participants who are transgender individuals may face
additional barriers to, or be denied, clinically appropriate gender-
affirming care.
---------------------------------------------------------------------------
\684\ Brian W. Ward et al., U.S. Dep't of Health & Human Servs.,
Ctrs. for Disease Control & Prevention, National Health Statistics
Report: Sexual Orientation & Health Among U.S. Adults: National
Health Interview Survey, 2013 (2014), https://www.cdc.gov/nchs/data/nhsr/nhsr077.pdf.
---------------------------------------------------------------------------
Sections 1894(f)(4) and 1934(f)(4) of the SSA provide authority for
the establishment of beneficiary safeguards to ensure the health and
safety of all PACE participants, including ensuring they have access to
all required PACE items and services. We are proposing changes to 42
CFR 460.98(b)(3) and 460.112(a) to ensure the health and safety of PACE
participants by establishing express protections against discriminatory
actions based on sexual orientation and gender identity.
Finally, the Department proposes that if any of the provisions at
42 CFR 460.98(b)(3) and 460.112(a) is held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, it shall be severable from its respective sections and
shall not affect the remainder thereof or the application of the
provision to other persons not similarly situated or to other
dissimilar circumstances. In enforcing the nondiscrimination provisions
in these CMS regulations, HHS will comply with laws protecting the
exercise of conscience and religion, including RFRA and all other
applicable legal requirements.
C. Insurance Exchanges and Group and Individual Health Insurance
Markets
LGBTQI+ people face barriers to obtaining appropriate health care,
including access to insurance and coverage for needed services. For
these reasons--as discussed in greater detail throughout this preamble
related to access to nondiscriminatory health coverage--and given the
Department's goal to ensure consistency across its nondiscrimination
policies and programs and entities subject to Section 1557 as discussed
previously, the Department here proposes to amend 45 CFR 147.104,
155.120, 155.220, 156.200, and 156.1230, so that they explicitly
identify and recognize discrimination on the basis of sexual
orientation and gender identity as prohibited forms of discrimination
based on sex.
The Department proposed similar amendments to these same
regulations in the 2023 Payment Notice proposed rule. However, because
this proposed rule addressing Section 1557 also would address issues
related to prohibited discrimination based on sex, the Department
determined that it would be most prudent to address the
nondiscrimination proposals related to sexual orientation and gender
identity in this proposed rule to ensure consistency across the
policies and requirements applicable to entities subject to Section
1557. When issuing a final rule on the provisions proposed in this
rule, we intend to also respond to the comments already submitted on
the similar proposal included in the 2023 Payment Notice proposed rule.
Accordingly, there is no need for entities that commented on these
proposals in the 2023 Payment Notice proposed rule to submit
duplicative comments.
As described above, Section 1557 prohibits discrimination in health
programs or activities, any part of which receives Federal financial
assistance. Similarly, as the Department noted in the 2020 Rule, CMS
also possesses statutory authority to prohibit discrimination in the
Exchanges. CMS relies on these authorities for the proposed revisions
discussed in section V.C.1 of the preamble.\685\ In the respective
preambles to Sec. Sec. 155.120(c), 155.220(j), 156.200(e), and
156.1230(b), CMS identifies and discusses the specific statutory
authorities (in addition to Section 1557) that CMS relies upon for the
proposals to prohibit discrimination based on sexual orientation and
gender identity. Relying on authority separate from Section 1557, CMS
also re-proposes the revision and clarification discussed in section
V.C.2 of the preamble, related to Sec. Sec. 147.104 and 156.125.
Section 147.104 applies to issuers offering non-grandfathered health
insurance coverage in the group and individual markets, and Sec.
156.125 applies to issuers offering non-grandfathered health insurance
coverage in the small group and individual markets. Both of these
provisions therefore apply to issuers that may not be entities covered
by Section 1557. For this reason, CMS does not rely on Section 1557
authority with respect to these provisions.
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\685\ 85 FR 37160, 37219, 37218-21 (June 19, 2020).
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Finally, the Department proposes that if any of the provisions at
45 CFR 147.104(e), 155.120(c), 155.220(j), 156.200(e), or 156.1230(b)
is held to be invalid or unenforceable by its terms, or as applied to
any person or circumstance, it shall be severable from its respective
sections and shall not affect the remainder thereof or the application
of the provision to other persons not similarly situated or to other
dissimilar circumstances. In enforcing the nondiscrimination provisions
in these CMS regulations, HHS will comply with laws protecting the
exercise of conscience and religion, RFRA and all other applicable
legal requirements.
1. Health Insurance Exchanges
a. Non-interference With Federal Law and Nondiscrimination Standards
(Sec. 155.120)
Section 155.120(c) currently provides that in order to avoid
interference and comply with applicable nondiscrimination statutes, the
states and the Exchanges must not discriminate based on race, color,
national origin, disability, age, or sex. Previously, in the final rule
``Patient Protection and Affordable Care Act; Establishment of
Exchanges and Qualified Health Plans; Exchange Standards for
Employers'' (Exchange Standards final rule), pursuant to the authority
provided in section 1321(a)(1)(A) of the ACA to regulate the
establishment and operation of an Exchange, the Department finalized
Sec. 155.120(c) to also prohibit discrimination based on sexual
orientation and gender identity.\686\ The 2020 Rule removed the terms
``sexual orientation'' and ``gender identity'' from the regulation
text. For the reasons stated earlier in section V.C. of the preamble,
for consistency with the proposals elsewhere in this proposed rule, to
ensure that sexual orientation and gender identity are added, and to
promote consistency across HHS programs, we propose to amend 45 CFR
155.120(c) by revising ``sex'' to ``sex (including sexual orientation
and gender identity)''.
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\686\ 77 FR 18310 (Mar. 27, 2012).
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In addition to the Section 1557 authority discussed above, section
1312(a)(1)(A) of the ACA also authorizes CMS to prohibit discrimination
in Exchanges pursuant to the authority to establish requirements with
respect to the operation of Exchanges.\687\ Pursuant
[[Page 47896]]
to this authority, HHS finalized in the Exchange Standards final rule
that a State must comply with any applicable nondiscrimination
statutes, specifically finalizing that a State must not operate an
Exchange in such a way as to discriminate on the basis of race, color,
national origin, disability, age, sex, gender identity, or sexual
orientation. CMS proposes to exercise that same authority here to amend
Sec. 155.120(c) to again prohibit states and Exchanges carrying out
Exchange requirements from discriminating based on sexual orientation
and gender identity. Section 1321(a)(1)(A) of the ACA is the same
authority CMS relies upon for implementation of existing
nondiscrimination protections at Sec. 155.120(c) that currently
prohibit discrimination on the basis of race, color, national origin,
disability, age, or sex.
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\687\ 85 FR 37218-21.
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We seek comment on this proposal. However, we note that the
Department proposed similar amendments to this section in the 2023
Payment Notice proposed rule. Accordingly, there is no need for
entities that commented on these proposals in the 2023 Payment Notice
proposed rule to submit duplicative comments.
b. Federally-Facilitated Exchange Standards of Conduct (Sec. 155.220)
Section 155.220(j)(2)(i) currently states that an agent, broker or
web-broker that assists with or facilitates enrollment through a
Federally-facilitated Exchange or assists individuals in applying for
advance payment of the premium tax credit and cost-sharing reductions
for QHPs sold through a Federally-facilitated Exchange must provide
consumers with correct information, without omission of material fact,
regarding the Federally-facilitated Exchange, QHPs offered through the
Federally-facilitated Exchange, and insurance affordability programs,
and refrain from marketing or conduct that is misleading (including by
having a direct enrollment website that HHS determines could mislead a
consumer to believe they are visiting HealthCare.gov), coercive, or
discriminates based on race, color, national origin, disability, age,
or sex. This provision also applies to agents, brokers, and web-brokers
in State-based Exchanges on the Federal platform under Sec.
155.220(l). Previously, in the Patient Protection and Affordable Care
Act; HHS Notice of Benefit and Payment Parameters for 2017 (2017
Payment Notice final rule),\688\ we finalized Sec. 155.220(j)(2)(i) to
also prohibit discrimination based on sexual orientation and gender
identity. The 2020 Rule removed the terms ``sexual orientation'' and
``gender identity'' from the regulation text. For the reasons stated
earlier in section V.C. of the preamble, for consistency with the
proposals elsewhere in this proposed rule, to ensure that sexual
orientation and gender identity are added, and to promote consistency
across HHS programs, the Department proposes to amend 45 CFR
155.220(j)(2)(i) by revising ``sex'' to ``sex (including sexual
orientation and gender identity)''.
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\688\ 81 FR 12204 (May 9, 2016).
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In addition to Section 1557 authority discussed above, section
1312(e) of the ACA grants CMS independent statutory authority to
establish procedures for States to permit agents and brokers to enroll
consumers in QHPs through the Federally-facilitated Exchanges, as
described in Sections 1312(e) of the ACA, and the authority to
establish requirements with respect to the operation of Exchanges, the
offering of QHPs through such Exchanges, and other requirements as the
Secretary determines appropriate under Sections 1321(a)(1)(A), (B), and
(D) of the ACA. Pursuant to this authority, in the 2017 Payment Notice
final rule, HHS finalized at Sec. 155.220 standards of conduct for
agents and brokers that assist consumers to enroll in coverage through
the Federally-facilitated Exchanges to protect consumers and ensure the
proper administration of the Federally-facilitated Exchanges, including
nondiscrimination standards at Sec. 155.220(j)(2)(i) that prohibited
agents, brokers and web-brokers described in paragraph (j)(1) from
discriminating based on sexual orientation and gender identity. CMS
further explained that such standards of conduct were necessary to
protect against agent and broker conduct that is harmful towards
consumers, or that prevents the efficient operation of the Federally-
facilitated Exchanges. CMS proposes to exercise that same authority
here to amend Sec. 155.220(j)(2)(i) to again prohibit an individual or
entity described in paragraph (j)(1) from discriminating based on
sexual orientation and gender identity. Sections 1312(e) and
1321(a)(1)(A), (B), and (D) of the ACA are the same authorities CMS
relies upon for implementation of existing nondiscrimination
protections at Sec. 155.220(j)(2)(i).
We seek comment on this proposal. However, we note that the
Department proposed similar amendments to this section in the 2023
Payment Notice proposed rule. Accordingly, there is no need for
entities that commented on these proposals in the 2023 Payment Notice
proposed rule to submit duplicative comments.
c. QHP Issuer Participation Standards (Sec. 156.200)
Section 156.200(e) states that a QHP issuer must not, with respect
to its QHP, discriminate on the basis of race, color, national origin,
disability, age, or sex. Previously, in the Patient Protection and
Affordable Care Act; Establishment of Exchanges and Qualified Health
Plans; Exchange Standards for Employers'' (2012 Exchange Standards)
final rule, we finalized Sec. 156.200(e) to also prohibit
discrimination based on sexual orientation and gender identity.\689\ In
the ``Patient Protection and Affordable Care Act; Standards Related to
Essential Health Benefits, Actuarial Value, and Accreditation; Final
Rule'' (EHB final rule), we finalized at Sec. 156.125 that the
nondiscrimination requirements in Sec. 156.200 also apply to all
issuers required to provide coverage of EHB, thereby prohibiting
discrimination based on factors such as sexual orientation and gender
identity.\690\ (See further discussion of Sec. 156.125 in section
V.C.2 of this preamble.) The 2020 Rule removed the terms ``sexual
orientation'' and ``gender identity'' from the regulation text. For the
reasons stated earlier in section V.C. of the preamble, for consistency
with the proposals elsewhere in this proposed rule, to ensure that
sexual orientation and gender identity are added, and to promote
consistency across HHS programs, we propose to amend 45 CFR 156.200(e)
by revising ``sex'' to ``sex (including sexual orientation and gender
identity)''.
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\689\ 77 FR 18310.
\690\ 78 FR 12834 (Feb. 25, 2013).
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In addition to the Section 1557 authority discussed above, section
1311(c)(1)(A) of the ACA gives CMS the statutory authority to prohibit
discrimination by QHP issuers. Accordingly, CMS requires QHP issuers to
comply with applicable state laws and regulations regarding marketing
by health insurance issuers and not employ marketing practices or
benefit designs that will have the effect of discouraging the
enrollment of individuals with significant health needs. CMS is
authorized to interpret and implement this requirement, and to set
additional requirements for QHPs under its authority to establish
requirements with respect to the offering of QHPs through the Exchanges
in section 1321(a)(1)(B) of the ACA.\691\ Pursuant to this authority to
set QHP standards in
[[Page 47897]]
section 1321(a)(1)(B) of the ACA, HHS finalized in the 2012 Exchange
Standards final rule requirements at Sec. 156.200(e) intended to
protect enrollees and potential enrollees from discriminatory
practices, including on the basis of sexual orientation and gender
identity. CMS proposes to exercise that same authority here to amend
Sec. 156.200(e) to again prohibit QHPs from discriminating based on
sexual orientation and gender identity. Section 1321(a)(1)(B) of the
ACA is the same authority CMS relies upon for implementation of
existing nondiscrimination protections at Sec. 156.200(e).
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\691\ 85 FR 37218-37221.
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We seek comment on this proposal. However, we note that the
Department proposed similar amendments to this section in the 2023
Payment Notice proposed rule. Accordingly, there is no need for
entities that commented on these proposals in the 2023 Payment Notice
proposed rule to submit duplicative comments.
d. Direct Enrollment With the QHP Issuer in a Manner Considered To Be
Through the Exchange (Sec. 156.1230)
Section 156.1230(b)(2) states that the QHP issuer must provide
consumers with correct information, without omission of material fact,
regarding the Federally-facilitated Exchange, QHPs offered through the
Federally-facilitated Exchange, and insurance affordability programs,
and refrain from marketing or conduct that is misleading a consumer
into believing they are visiting HealthCare.gov, coercive, or
discriminates based on race, color, national origin, disability, age,
or sex. Previously, in the 2017 Payment Notice final rule (81 FR 12203
(May 9, 2016)), HHS finalized at Sec. 155.220(j)(2)(i) standards that
prohibited agents, brokers and web-brokers from discriminating on the
basis of sexual orientation and gender identity, among other factors.
In the Patient Protection and Affordable Care Act; HHS Notice of
Benefit and Payment Parameters for 2018 (2018 Payment Notice final
rule), we added this nondiscrimination standard from Sec. 155.220(j)
to Sec. 156.1230(b), so that the nondiscrimination protections on the
basis of sexual orientation and gender identity also applied to issuers
using direct enrollment on a Federally-facilitated Exchange.\692\ The
2020 Rule removed the terms ``sexual orientation'' and ``gender
identity'' from the regulation text. For the reasons stated earlier in
section V.C. of the preamble, for consistency with the proposals
elsewhere in this proposed rule, to ensure that sexual orientation and
gender identity are added, and to promote consistency across HHS
programs, we propose to amend 45 CFR 156.1230(b)(2) by revising ``sex''
to ``sex (including sexual orientation and gender identity)''.
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\692\ 81 FR 94058 (Dec. 22, 2016).
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In addition to Section 1557 authority discussed above, section
1321(a)(1)(A), (B), and (D) of the ACA gives CMS statutory authority to
prohibit discrimination in enrollment through the Exchanges by issuers
of QHPs--namely the authority to establish requirements with respect to
the operation of Exchanges, the offering of QHPs through such
Exchanges, and other requirements as the Secretary determines
appropriate. Pursuant to this authority, in the 2018 Payment Notice
final rule, HHS finalized at Sec. 156.1230(b)(2) standards applicable
to issuers using direct enrollment on a Federally-facilitated Exchange
to require that issuers refrain from marketing or conduct that is
misleading, coercive, or discriminatory, including on the basis of
sexual orientation or gender identity. HHS explained it was adding this
nondiscrimination standard from Sec. 155.220(j) to Sec. 156.1230(b)
so that the nondiscrimination protections on the basis of sexual
orientation and gender identity also applied to issuers using direct
enrollment on a Federally-facilitated Exchange. HHS proposes to
exercise that same authority here to amend Sec. 156.1230(b) to again
prohibit issuers using direct enrollment on a Federally-facilitated
Exchange from discriminating based on sexual orientation and gender
identity. Sections 1321(a)(1)(A), (B), and (D) of the ACA are the same
authority CMS relies upon for implementation of existing
nondiscrimination protections at Sec. 156.200(e).
We seek comment on this proposal. However, we note that the
Department proposed similar amendments to this section in the 2023
Payment Notice proposed rule. Accordingly, there is no need for
entities that commented on these proposals in the 2023 Payment Notice
proposed rule to submit duplicative comments.
2. Prohibition of Discrimination--Group and Individual Health Insurance
Markets
a. Guaranteed Availability of Coverage (Sec. 147.104)
Section 147.104(e) states that a health insurance issuer and its
officials, employees, agents, and representatives must not employ
marketing practices or benefit designs that will have the effect of
discouraging the enrollment of individuals with significant health
needs in health insurance coverage or discriminate based on an
individual's race, color, national origin, present or predicted
disability, age, sex, expected length of life, degree of medical
dependency, quality of life, or other health conditions. Pursuant to
section 1311(c)(1)(A) of the ACA, the HHS Secretary was required to
establish by regulation criteria for certification that require QHP
issuers to meet marketing requirements and not employ marketing
practices or benefit designs that will have the effect of discouraging
the enrollment of individuals with significant health needs in QHPs. As
discussed in section V.C.2.c. of this preamble, under the authority of
section 1321(a) of the ACA, which provides the HHS Secretary broad
rulemaking authority with respect to the establishment and operation of
Exchanges and the offering of QHPs through such Exchanges, in the 2012
Exchange Standards final rule, CMS codified a regulation implementing
prohibitions on discrimination by QHP issuers at Sec. Sec. 156.200(e)
and 156.225(b).\693\ Under the authority in section 2702 of the PHS Act
as well as the general rulemaking authority in section 2792 of the PHS
Act, which provides the HHS Secretary broad rulemaking authority to
promulgate regulations as may be necessary or appropriate to carry out
the provisions of title XXVII of the PHS Act, the ``Patient Protection
and Affordable Care Act; Health Insurance Market Rules; Rate Review''
final rule adopted a similar standard in Sec. 147.104(e), applying
this requirement market-wide to issuers offering non-grandfathered
plans in the group and individual health insurance markets, regardless
of whether the coverage is offered through or outside of an
Exchange.\694\
---------------------------------------------------------------------------
\693\ 77 FR 18310.
\694\ 78 FR 13406 (Feb. 27, 2013).
---------------------------------------------------------------------------
For the proposal to amend Sec. 147.104, CMS relies on its
authorities under sections 2702 and 2792 of the PHS Act, which provide
the HHS Secretary broad rulemaking authority to promulgate regulations
as may be necessary or appropriate to carry out the provisions of title
XXVII of the PHS Act. These are the same authorities CMS relies upon
for implementation of existing nondiscrimination protections at Sec.
147.104(e). Utilizing these same authorities to again prohibit
discrimination based on sexual orientation and gender identity would be
consistent with the authority CMS relies upon for those existing
[[Page 47898]]
protections at Sec. 147.104(e) that currently prohibit discrimination
on the basis of race, color, national origin, present or predicted
disability, age, sex, expected length of life, degree of medical
dependency, quality of life, or other health conditions.
CMS does not propose to rely on Section 1557 authority for this
amendment for two primary reasons. First, Sec. 147.104 applies to non-
grandfathered health insurance coverage in the individual or group
market, and not all of such issuers will receive Federal financial
assistance such that they would be subject to Section 1557. Second,
under PHS Act section 2723, states have primary enforcement authority
over issuers with respect to regulations implementing title XXVII of
the PHS Act, including Sec. 147.104. If CMS determines that a state is
not substantially enforcing a provision in title XXVII, then CMS may
enforce the provision's requirements. Because states would not have
authority to enforce Section 1557, CMS is of the view that partial
reliance on Section 1557 authority could unnecessarily complicate
enforcement efforts.
For the reasons stated earlier in section V.C. of the preamble, for
consistency with the proposals elsewhere in this proposed rule, to
ensure that sexual orientation and gender identity are added, and to
promote consistency across HHS programs, we propose to amend 45 CFR
147.104(e) by revising ``sex'' to ``sex (including sexual orientation
and gender identity)''.
We seek comment on this proposal. However, we note that the
Department proposed similar amendments to this section in the 2023
Payment Notice proposed rule. Accordingly, there is no need for
entities that commented on these proposals in the 2023 Payment Notice
proposed rule to submit duplicative comments.
b. Prohibition on Discrimination (Sec. 156.125)
Elsewhere in this rule, we propose to amend Sec. 156.200(e) to
prohibit discrimination based on sexual orientation and gender
identity. If these proposed nondiscrimination protections are
finalized, Sec. 156.125(b) would accordingly require issuers providing
EHB to comply with such nondiscrimination requirements. Specifically,
Sec. 156.125(b) states that an issuer providing EHB must comply with
the requirements of Sec. 156.200(e), which currently states that a QHP
issuer must not, with respect to its QHP, discriminate on the basis of
race, color, national origin, disability, age, or sex. HHS previously
codified nondiscrimination protections based on sexual orientation and
gender identity at Sec. 156.200(e), simultaneously requiring that
issuers providing EHB comply with such requirements by virtue of the
cross-reference in Sec. 156.125(b) to Sec. 156.200(e). The 2020 Rule
amendments removed from Sec. 156.200(e) any reference to sexual
orientation and gender identity. As discussed in section V.C.1.c of the
preamble, we propose to amend 45 CFR 156.200(e) by revising ``sex'' to
``sex (including sexual orientation and gender identity)''.
If the proposals at Sec. 156.200(e) are finalized, issuers
providing EHB would again be required under Sec. 156.125(b) to comply
with nondiscrimination protections in Sec. 156.200(e) that prohibit
discrimination on the basis of sexual orientation and gender identity.
Section 1302(b) of the ACA also gives CMS the statutory authority
to prohibit discrimination in the small group and individual markets
pursuant to the authority to define EHB at section 1302(b) of the ACA.
The statute specifies that in defining EHB the Secretary must take into
account the health care needs of diverse segments of the population,
including women, children, persons with disabilities, and other groups.
The EHB requirements apply to non-grandfathered health insurance
coverage in the individual and small group markets under section
2707(a) of the PHS Act. CMS has the authority to interpret and
implement these provisions under its general rulemaking authorities in
sections 1321(a)(1)(B) and (D) of the ACA and section 2792 of the PHS
Act. Pursuant to those authorities, HHS finalized in the EHB final rule
that Sec. 156.125 prohibits benefit discrimination on the grounds
articulated by Congress in section 1302(b)(4) of the ACA, as well as
those in Sec. 156.200(e), which at the time included race, color,
national origin, disability, age, sex, gender identity, and sexual
orientation. It is under that same exercise of authority here that
Sec. 156.125 would again prohibit discrimination on the basis of
sexual orientation and gender identity if the proposed changes to
include such factors in the nondiscrimination protections at Sec.
156.200(e) are finalized. Sections 1302(b) and 1321(a)(1)(B) and (D) of
the ACA and sections 2707(a) and 2792 of the PHS Act are the same
authorities CMS relies upon for implementation of existing
nondiscrimination protections at Sec. 156.125. Relying on these same
authorities to again prohibit discrimination based on sexual
orientation and gender identity at Sec. 156.125 by cross-reference to
the nondiscrimination protections at Sec. 156.200(e) would be
consistent with the authority CMS relies upon for the existing
protections at Sec. 156.125 that prohibit discrimination on the basis
of race, color, national origin, disability, age, or sex by cross-
reference to Sec. 156.200(e).
CMS does not rely on Section 1557 authority for this amendment for
the same two primary reasons described in section V.C.2.a of this
preamble. First, Sec. 156.125 applies to issuers offering non-
grandfathered health insurance coverage in the individual or small
group market, and not all of such issuers will receive Federal
financial assistance such that they would be subject to Section 1557.
Second, under PHS Act section 2723, states have primary enforcement
authority over issuers with respect to regulations implementing title
XXVII of the PHS Act, including Sec. 156.125. If CMS determines that a
state is not substantially enforcing a provision in title XXVII, then
CMS may enforce the provision's requirements. Because states would not
have authority to enforce Section 1557, CMS is of the view that partial
reliance on Section 1557 authority could unnecessarily complicate
enforcement efforts.
We seek comment on this proposal. However, we note that the
Department proposed similar amendments to this section in the 2023
Payment Notice proposed rule. Accordingly, there is no need for
entities that commented on these proposals in the 2023 Payment Notice
proposed rule to submit duplicative comments.
VI. Executive Order 12866 and Related Executive Orders on Regulatory
Review
A. Regulatory Impact Analysis
We have examined the impacts of the proposed rule under E.O. 12866,
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.'s 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). This proposed rule is an
economically significant regulatory action as defined by E.O. 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the costs of the proposed rule
[[Page 47899]]
are small relative to the revenue of covered entities, including
covered small entities, and because even the smallest affected entities
would be unlikely to face a significant impact, we propose to certify
that the proposed rule will not have a significant economic impact on a
substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) generally
requires us to prepare a written statement, which includes an
assessment of anticipated costs and benefits, before proposing ``any
rule that includes any Federal mandate that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted annually
for inflation) in any one year.'' The current threshold after
adjustment for inflation is $165 million, using the most current (2021)
Implicit Price Deflator for the Gross Domestic Product. This proposed
rule is not subject to the Unfunded Mandates Reform Act because it
falls under an exception for regulations that establish or enforce any
statutory rights that prohibit discrimination on the basis of race,
color, religion, sex, national origin, age, handicap, or
disability.\695\
---------------------------------------------------------------------------
\695\ 2 U.S.C. 1503(2).
---------------------------------------------------------------------------
The Background and Reasons for the Proposed Rulemaking sections at
the beginning of this preamble contain a summary of this proposed rule
and describe the reasons it is needed.
1. Summary of Costs and Benefits
This analysis quantifies several categories of costs to covered
entities and to the Department under the proposed rule. Specifically,
we quantify costs associated with covered entities training employees,
revising policies and procedures, and costs associated with notices,
including the notice of nondiscrimination and notice of availability of
language assistance services and auxiliary aids and services. We
quantify costs associated with provisions of the proposed rule related
to documenting training activities performed under the proposed rule.
We also quantify incremental costs associated with expanded coverage
for gender-transition-related medical care. We conclude that the
proposed rule would result in annualized costs over a 5-year time
horizon of $560 million or $551 million, corresponding to a 7% or a 3%
discount rate. This analysis also addresses uncertainty in costs
associated with notices and expanded gender-transition-related medical
care, which is discussed in greater detail in the main body of the
analysis. We separately report a full range of cost estimates of about
$427 million to $1,093 million using a 7% discount rate, and a full
range of cost estimates of about $417 million to $1,084 million using a
3% discount rate.
In addition to these quantified cost estimates, the main analysis
includes a discussion of costs that we do not quantify, and a
discussion of the potential benefits under the rule that we similarly
do not quantify. In addition to the impacts that we quantify, this
proposed rule could also result in increases in premiums, which would
result in increases in Exchange user fees and Federal expenditures for
advance payments of the premium tax credit. We request comments on our
estimates of the cost and benefits of this proposed rule, including the
impacts that are not quantified in this analysis.
Table 1--Annualized Costs of the Proposed Rule
[$ millions/year (percent)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Primary estimate Low estimate High estimate Year dollars Discount rate Period covered (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
$560..................................................... $427 $1,093 2020 7 2024-2028
551...................................................... 417 1,084 2020 3 2024-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
a. Baseline Conditions
Section 1557 prohibits an individual from being excluded from
participation in, denied the benefits of, or otherwise subjected to
discrimination on the basis of race, color, national origin, sex, age,
or disability in certain health programs and activities. It applies to
any health program or activity, any part of which is receiving Federal
financial assistance, and to any program or activity that is
administered by an Executive Agency or any entity established under
Title I of the ACA.\696\ On May 18, 2016, the Department published a
final rule to implement Section 1557 under the statute and 5 U.S.C.
301. On June 19, 2020, the Department published a final rule that
revised the Department's approach to implementing Section 1557. As
described in the Background section of this preamble in greater detail,
neither final rule was fully implemented as published, and certain
provisions of the 2020 Rule remain the subject of ongoing litigation.
The Background section of the preamble also discusses the Department's
May 10, 2021 Bostock Notification, in accordance with the Supreme
Court's decision in Bostock and based on the plain language of Title
IX, that the Department would interpret Section 1557's prohibition on
sex discrimination to include (1) discrimination on the basis of sexual
orientation and (2) discrimination on the basis of gender
identity.\697\
---------------------------------------------------------------------------
\696\ 42 U.S.C. 18116.
\697\ 86 FR 27984 (May 25, 2021).
---------------------------------------------------------------------------
The baseline scenario of no further regulatory action is
substantially informed by the RIAs published with the 2016 and 2020
Rules. The 2016 RIA identified five sources of monetized costs:
training and familiarization, enforcement, notice publication, sex
discrimination policy and procedure changes, and language access plans.
The bulk of the monetary impacts identified in the 2016 RIA occur in
the first two years under the final rule, with costs continuing in
future years only for enforcement and language access plans.
The 2020 RIA adopted many of the assumptions contained in the 2016
RIA. For example, it assumed that many of the initial activities
anticipated under the 2016 rule were performed, and that the first two
years of costs attributable to the 2016 Final Rule were incurred.\698\
The 2020 RIA identifies cost savings only ``from the repeal of (1) the
provision on the incentive for covered entities to develop language
access plans and (2) the provisions on notice and taglines.'' The 2020
RIA also identifies costs in the first year ``on covered entities'
voluntary actions to re-train their employees on, and adopt policies
and procedures to implement, the legal requirements of this final
rule.''
---------------------------------------------------------------------------
\698\ E.g., 85 FR 37160, 37235 (June 19, 2020) (``The Department
assumes sunk costs cannot be recovered by this rule, and therefore
that initial language access plan development costs attributable to
the 2016 Rule cannot be recovered.'').
---------------------------------------------------------------------------
In establishing a baseline scenario, this analysis similarly
maintains a number of assumptions and estimates contained in prior
analyses. For
[[Page 47900]]
example, the baseline scenario includes some ongoing costs that are
attributable to the 2016 Rule, such as the costs of enforcement. The
2016 RIA estimated that the costs of enforcement would be $98.2 million
(reported in 2020 dollars), which we adopt as the costs under both the
baseline and proposed rule scenarios. Similarly, we adopt the
assumption in the 2020 RIA that covered entities continue to provide
ongoing training attributable to the 2016 Rule, which was not impacted
by the 2020 Rule. We include these ongoing training activities,
including annual refresher training for returning employees and
training for new employees, in the baseline scenario of no regulatory
action. In the next section, we discuss the incremental costs of the
proposed rule, which exclude ongoing costs attributable to prior
rulemaking.
b. Costs of the Proposed Rule
This analysis anticipates that the proposed rule would result in
one-time costs to covered entities to train employees and revise
policies and procedures. The proposed rule would result in costs
associated with a revised approach to notices, including the notice of
nondiscrimination and notice of availability of language assistance
services and auxiliary aids and services. The proposed rule would also
result in costs associated with provisions related to documenting
training activities performed under the proposed rule. The proposed
rule might result in additional costs associated with expanded coverage
for gender-transition-related medical care. We discuss the potential
costs associated with this expanded coverage and the potential that
some or all of these costs would be offset by reductions in spending on
other types of care. The analysis also discusses other potential costs
of the proposed rule that we do not quantify.
Training
The Department anticipates that some covered entities would incur
costs to train or retrain employees under the proposed rule. To
calculate the costs related to training, we follow an approach common
to both the 2016 and 2020 RIAs. Both analyses adopted an estimate of
275,002 covered entities that would train their employees on the
requirements and used this figure as the basis for calculating the
total costs. The 2020 RIA adjusted this figure downwards by 50%,
anticipating that some covered entities would not modify their
procedures in response to the 2020 Final Rule, and would therefore not
need to offer new training. Both RIAs anticipated that employers would
most likely train employees who interact with the public and recognized
that the percentage of employees that interact with patients and the
public vary by covered entity. To account for this, the analyses
adopted a central estimate of 50% of staff at covered entities that
received one-time training on the requirements of the regulation.
Both RIAs reported the number of employees at covered entities by
occupation category. To monetize the total costs of training, the RIAs
adopted a value of time based on the average fully loaded wage rate for
each occupation, combined with an assumption about the duration of the
training. The 2016 RIA assumed that 50% of total employees at covered
entities would receive training, while the 2020 RIA assumed that 25% of
employees would receive training. Both RIAs assumed the typical
training would last one (1) hour. For the purpose of this analysis, we
assume that 75% of total employees at covered entities would receive
training, and that this training would last one (1) hour. This estimate
is consistent with an assumption that all covered entities would revise
their policies and procedures under the proposed rule, and that most
employees at covered entities would receive training.
As a necessary first step in calculating the incremental total
costs of training attributable to the proposed rule, we have collected
the most recent available data on the number of employees that would
likely undergo training under the proposed rule, and data on the
average wage rate by occupation for these employees.
The first category of health care staff that may receive training
comprises health diagnosing and treating practitioners. This category
includes physicians, dentists, optometrists, physician assistants,
occupational, physical, speech and other therapists, audiologists,
pharmacists, registered nurses, and nurse practitioners. The U.S.
Bureau of Labor Statistics (BLS) Occupational code for this grouping is
29-1000, and the 2020 reported count for this occupational group is
approximately 5.6 million, with average loaded wages of $101.16 per
hour.
The second category of health care staff that the Department
assumes will receive training comprises degreed technical staff
(Occupation code 29-2000) and accounts for 2.9 million workers with
average loaded wages of $47.10 per hour. Technicians work in almost
every area of health care: x-ray, physical, speech, psychiatric,
dietetic, laboratory, nursing, and records technicians, to name but a
few areas.
The third category of health care staff that the Department assumes
will receive training comprises non-degreed medical assistants
(Occupation code 31-0000), and includes psychiatric and home health
aides, orderlies, dental assistants, and phlebotomists. Health care
support staffs (technical assistants) operate in the same medical
disciplines as technicians, but often lack professional degrees or
certificates. The Department refers to this workforce as non-degreed,
compared to medical technicians who generally have degrees or
certificates. There are approximately 5.9 million individuals employed
in these occupations in the health care and social assistance sector,
with average loaded wages of $30.72 per hour.
The fourth category of health care staff that the Department
assumes will receive training is health care managers (approximately
0.4 million individuals based on BLS data for Occupation code 11-9111),
with average loaded wages of $114.24 per hour.
The fifth category of health care staff that the Department assumes
will receive training is office and administrative assistants--Office
and Administrative Support Occupation (Occupation code 43-0000). These
workers are often the first staff patients encounter in a health
facility and, because of this, covered entities might find it important
that staff, such as receptionists and assistants, receive training on
the regulatory requirements. Approximately 2.7 million individuals were
employed in these occupations in health facilities in 2020, with
average loaded wages of $38.50 per hour. The Department assumes that
outreach workers are included in the five categories listed above.
These figures sum to 17.4 million employees at covered entities, of
which we assume 13.1 million would receive training attributable to the
proposed rule. Across the five occupation categories, we compute a
weighted hourly wage rate of $29.59, or a weighted fully loaded hourly
wage rate of $59.18. Assuming that the average training takes one (1)
hour and adopting a value of time based on fully loaded wage rates, we
estimate the total cost of training of about $775 million, which would
be incurred in the first year. As a sensitivity analysis, we considered
the scenario of covered entities providing training to all employees,
not just employees who interact with the public. Under this scenario,
the total cost of training would increase, to about $1.0 billion. These
costs are likely overstated since this training may supplement or
replace expected annual or other ongoing training activities at covered
[[Page 47901]]
entities. To the extent that covered entities reduce time spent on
other training activities, these costs would offset some of the total
costs attributable to the proposed rule.
In addition to the first-year training costs, we anticipate that
the proposed rule would result in additional costs associated with
ongoing training, including annual refresher training for returning
employees or and training for new employees. As discussed in the
Baseline Conditions section, we assume that many covered entities are
routinely carrying out these activities, absent further regulatory
action. However, we anticipate that the proposed rule would result in a
larger share of employees at covered entities receiving such training.
To quantify the change in training activities between the baseline
scenario and the proposed rule scenario, we take the difference between
the share of employees receiving training under the baseline scenario
and the proposed rule scenario. We carry through an assumption from the
2016 RIA, which assumed that 50% of total employees at covered entities
receive training and compare this to an assumption in this proposed RIA
that 75% of total employees at covered entities would receive training.
This yields an estimate of 25% of total employees at covered entities
that would receive training in subsequent years under the proposed
rule. We adopt the same weighted hourly wage estimate, number of
employees, and estimate the total cost of ongoing annual training costs
of $258 million. These costs would occur in years two through five in
the time horizon of this analysis.
Revising Policies and Procedures
As discussed above, the Department anticipates that all covered
entities, or approximately 275,002 entities, would revise their
policies and procedures under the proposed rule, with half of these
entities requiring fewer revisions. For covered entities with more
extensive revisions, we adopt the estimates contained in the 2020 RIA,
with four (4) total hours spent on revisions per entity. Of these,
three would be spent by a mid-level manager equivalent to a first-line
supervisor (Occupation code 43-1011), at a cost of $56.96 per hour
after adjusting for non-wage benefits and the indirect costs, while an
average of one hour would be spent by executive staff equivalent to a
general and operations manager (Occupation code 11-1021), at a cost of
$104.80 per hour after adjusting for non-wage benefits and indirect
costs. For covered entities with less extensive revisions, we assume
two total hours spent on revisions per entity. Of these, one would be
spent by a mid-level manager, and one would be spent by executive
staff.
We monetize the time spent on revising policies and procedures by
estimating a total cost per entity of $275.68 or $161.76, depending on
the extent of the revisions. For the 137,501 covered entities with more
extensive revisions, we estimate a cost of about $37.9 million. For the
137,501 covered entities with less extensive revisions, we estimate a
cost of about $22.2 million. We estimate the total cost associated with
revisions to policies and procedures under the proposed rule of $60.1
million.
The above estimates of time and number of entities that would
choose to revise their policies under the regulation are approximate
estimates based on general BLS data. Due to the wide range of types and
sizes of covered entities, from complex multi-divisional hospitals to
small neighborhood clinics and physician offices, the above estimates
of time and number of entities that would choose to revise their
policies under the regulation is difficult to calculate precisely.
Notices
The proposed rule would require a covered entity to provide a
notice of nondiscrimination to participants, beneficiaries, enrollees,
and applicants of its health program or activity, and members of the
public. It also would require the 275,002 covered entities to provide a
notice of availability of language assistance services and auxiliary
aids and services. These provisions resemble elements of the 2016 Rule
that were repealed in the 2020 Rule; however, the approach under the
proposed rule provides a narrower set of situations where covered
entities would be required to provide these notices. Both types of
notices are required (1) on an annual basis; (2) upon request; (3) at a
conspicuous location on the covered entity's health program or activity
website; and (4) in clear and prominent physical locations where the
health program or activity interacts with the public.
The notice of availability of language assistance services and
auxiliary aids and services is required in the following electronic and
written communications related to the covered entity's health programs
and activities: (1) notice of nondiscrimination required by proposed
Sec. 92.10; (2) notice of privacy practices required by 45 CFR
164.520; (3) application and intake forms; (4) notices of denial or
termination of benefits or services, including Explanations of Benefits
(EOBs) and notices of appeal and grievance rights; (5) communications
related to a person's rights, eligibility benefits, or services that
require or request a response from a participant, beneficiary,
enrollee, or applicant; (6) communications related to a public health
emergency; (7) consent forms and instructions related to medical
procedures or operations, medical power of attorney, or living will
(with an option of providing only one notice for all documents bundled
together); (8) discharge papers; (9) complaint forms; and (10) patient
and member handbooks.
For the purposes of the analysis, we base our estimates of the
number of communications containing these notices on a subset of the
communications identified in the 2020 RIA. We include communications
that are EOBs. The Department received feedback regarding the financial
burden imposed by applying the notice and tagline requirements to EOBs.
EOBs are typically an individual's first, and often only, notice of a
denial or termination of benefits or services, and as such the notice
and tagline requirements are essential in this context to ensure timely
and equitable access to appeals processes. Covered entities may provide
individuals with the option to opt out of receiving these notices on an
annual basis, which will reduce the cost and burden associated with
these requirements. In addition, as enrollees, participants, and
beneficiaries increasingly elect to receive EOBs electronically, we
expect the cost of these requirements to decrease over time. We adopt
the other estimates as a reasonable proxy for the number of
communications that would be anticipated under the proposed rule. These
estimates are intended to encompass all categories of notices required
under the proposed rule. Table 2 below reports the number of
communications containing notices anticipated under the proposed rule
and presents the costs of these communications. Our cost estimates
reflect a wide range of uncertainty in the cost per communication. For
our primary scenario, we adopt a central estimate of the average costs
to print and fold paper forms containing prescribing information of
$0.05 (calculated as the midpoint estimate of a range from $0.03 to
$0.07), reported in 2010 dollars.\699\ We explore the
[[Page 47902]]
sensitivity of the overall cost estimates under a low-cost ($0.035 per
unit) and high-cost ($0.32 per unit) scenario, reported in 2018
dollars, which matches the range contained in the 2020 RIA. We adjust
these per-unit cost inputs for inflation to 2020 price levels using the
Implicit Price Deflator, resulting in a primary per-unit cost estimate
of about $0.06 and a full range of about $0.04 to $0.33.\700\ Combining
these per-unit cost estimates with the count of each notice results in
a primary estimate of $78.4 million, with a range of estimates between
$47.8 million and $437.2 million. Following the approach in the 2020
RIA, we adjust this figure downwards by 50% to account for the lower
cost of electronic communications. For this adjustment, we adopt a
measure of the share of respondents reporting that they used a
``Digital (mobile app or website)'' method to contact or interact with
their health care insurer in the last year when viewing an online
statement.\701\ We anticipate that the share of communications
occurring online will increase over time, but have not accounted for a
trend for the 5-year time horizon of this analysis. This adjustment
results in a primary estimate of the adjusted annual total of $78.4
million, with a range of costs between $23.9 million and $218.6
million. These costs would occur in each year of the time horizon of
the analysis.
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\699\ U.S. Dep't of Health & Human Servs., Food & Drug Admin.,
Electronic Distribution of Prescribing Information for Human
Prescriptions Drugs, Including Biological Products (Proposed Rule),
79 FR 75506 (Dec. 18, 2014).
\700\ Gross Domestic Product: Implicit Price Deflator (GFPDEF),
Fed. Reserve Bank of St. Louis, https://fred.stlouisfed.org/series/GDPDEF (last visited June 15, 2022).
\701\ Saurabh Gupta et al., HFS Res. & Cognizant, Health
Consumers Want Digital: It's Time for Health Plans to Deliver, p. 4
(2021), https://www.cognizant.com/us/en/documents/hfs-health-consumers-want-digital-its-time-for-health-plans-to-deliver.pdf.
Table 2--Cost of Notice Provisions
[2020 dollars]
----------------------------------------------------------------------------------------------------------------
Cost scenario ($ millions)
Cost element Count (millions) --------------------------------------------------------
Low Primary High
----------------------------------------------------------------------------------------------------------------
Eligibility and enrollment 17.7 $0.7 $1.1 $6.0
communications.....................
Annual notice of benefits........... 123.0 4.6 7.5 41.8
Explanations of benefits--hospital 96.0 3.6 5.8 32.6
admissions.........................
Explanations of benefits--physician 941.0 34.9 57.3 319.5
visits.............................
Medical bills--hospital admissions.. 11.0 0.4 0.7 3.7
Medical bills--physician visits..... 99.0 3.7 6.0 33.6
---------------------------------------------------------------------------
Total, Unadjusted............... 1287.7 47.8 78.4 437.2
Total, Adjusted for Electronic 1030.2 23.9 39.2 218.6
Delivery.......................
----------------------------------------------------------------------------------------------------------------
Documentation Requirements
The proposed rule would require covered entities to
contemporaneously document certain other activities performed under the
proposed rule. This includes activities such as employees' completion
of the training required by this section in written or electronic form.
The proposed rule also requires covered entities to retain certain
records. These and other requirements, and the associated cost
estimates, are discussed in greater detail in the PRA Section.
The costs associated with retaining records related to grievances
filed with a covered entity is the time spent by the staff of covered
entities to store the complaints for no less than three (3) years. We
calculate the costs of labor as one (1) employee per covered entity
with more than 15 employees (41,250) \702\ spending 10 hours to store
complaints and the associated records required under proposed Sec.
92.8(c)(2) each year. We assume that administrative or clerical support
personnel would perform these functions. The mean hourly wage for this
occupation is $17.38 per hour, which we double to account for overhead
and other indirect costs. We estimate the costs of retaining records
related to grievances filed at all covered entities would be $14.3
million annually ($17.38 x 2 x 10 x 41,250). This estimation approach
will overstate the costs if many covered entities already retain
complaint information.
---------------------------------------------------------------------------
\702\ This estimate is consistent with the 2016 Rule's
Regulatory Impact Analysis: ``Of the 275,002 covered entities,
approximately 15% employ more than 15 employees, resulting in
approximately only slightly more than 41,250 covered entities being
required to have grievance procedures and designate a responsible
official.'' 81 FR 31375, 31452 (May 18, 2016).
---------------------------------------------------------------------------
The costs associated with documenting employee training is the time
spent by the staff of covered entities to (a) create training
attendance forms; and (b) store the training sign-up sheet. We
calculate the costs of labor as one (1) employee spending 15 minutes
(0.25 hours) to create the sign-up sheet during the first year and one
(1) employee spending one (1) hour collecting and storing the
attendance forms the first year and subsequent years. We assume that
administrative or clerical support personnel would perform these
functions. The mean hourly wage for this occupation is $17.38 per hour,
which we double to account for overhead and other indirect costs. We
estimate the costs of documenting employee training would be $11.9
million in the first year ($17.38 x 2 x 1.25 x 275,002) and $9.6
million in subsequent years ($1.738 x 2 x 1 x 275,002).
Expanding Coverage for Gender-Transition-Related Medical Care
In addition to the cost some covered health insurance issuers and
plans may incur for revising policies and procedures to comply with the
rule, there is a possibility that such issuers and plans may incur a de
minimis cost related to the cost of coverage for gender-transition-
related medical care. Various studies, however, suggest that any such
increased costs will likely be negligible, and that any increases may
be offset by savings from decreased utilization of other services.
In April 2012, the California Department of Insurance conducted an
Economic Impact Assessment on Gender Nondiscrimination in Health
Insurance that found that covering transgender individuals under
California's private and public health insurance plans would have an
``insignificant and immaterial'' impact on costs.\703\ This conclusion
was based
[[Page 47903]]
on evidence of low utilization and the estimated number of transgender
individuals in California. The transgender population of California was
estimated to range between 0.0022% and 0.0173%.\704\ The study revealed
that, contrary to common assumptions, not all transgender individuals
seek surgical intervention, and that gender-affirming health care
differs according to the needs and pre-existing conditions of each
individual.\705\ Despite expecting a possible spike in demand for
benefits due to former or current unmet demand, the California
Insurance Department concluded that any increased utilization that
might occur over time is likely to be so low that any resulting costs
remain actuarially immaterial.\706\ The Assessment notes the experience
of one employer that initially established premium surcharges to cover
the anticipated cost of transition-related care, reporting that the
employer subsequently eliminated the surcharges because they found that
the funds collected were nearly 15 times the amount expended on
care.\707\ While it did not analyze any original data, a 2018 analysis
by the state of Wisconsin's Department of Employee Trust Funds cited
numerous studies finding that the cost of coverage was minimal, and
noted that ``[w]hile it is challenging to predict the costs of care
averted for any condition, there is some evidence that the costs
associated with providing transgender-inclusive plans is met with
reduced costs related to comorbidities.'' \708\
---------------------------------------------------------------------------
\703\ State of Cal., Dep't of Ins., Economic Impact Assessment
Gender Nondiscrimination in Health Insurance, p. 1 (Apr. 13, 2012),
https://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
\704\ Id. at p. 3. More recent estimates indicate that a higher
share of the population in the United States identifies as
transgender (0.6% of the U.S. adult population), Andrew R. Flores et
al., The Williams Inst., UCLA Sch. of Law, Race and Ethnicity of
Adults Who Identify as Transgender in the United States, p. 2
(2016), https://williamsinstitute.law.ucla.edu/wp-content/uploads/Race-Ethnicity-Trans-Adults-US-Oct-2016.pdf.
\705\ State of Cal., Dep't of Ins., supra note 703, at p. 8.
\706\ Id. at p. 9.
\707\ Id. at pp. 6-7.
\708\ State of Wis., Dep't of Employee Trust Funds,
Correspondence Memorandum Re: Transgender Services Coverage, p. 6-8
(Aug. 14, 2018), https://etf.wi.gov/boards/groupinsurance/2018/08/22/item6a1/download?inline=.
---------------------------------------------------------------------------
Other studies looking at both public and private sector plans have
reached similar conclusions. One study published in the New England
Journal of Medicine projected that the cost for providing gender-
transition-related health care benefits to members of the military
would result in an annual increase of 0.012% of health care costs,
``little more than a rounding error in the military's $47.8 billion
annual health care budget.'' \709\ A 2013 study of 34 public and
private sector employers that provided nondiscriminatory health care
coverage found that providing gender-transition-related benefits to
treat gender dysphoria had ``zero to very low costs.'' \710\ A study
comparing costs and potential savings associated with covering gender-
transition-related care concluded that projected ``additional expenses
hold good value for reducing the risk of negative endpoints--HIV,
depression, suicidality, and drug abuse'' and noted that ``provider
coverage was cost-effective in 85% of simulations.'' \711\ More
recently, a 2021 survey of employers conducted by the Human Rights
Campaign noted that most employers who covered gender-transition-
related care reported only ``marginal increases'' in cost, on the order
of ``a fraction of a decimal point of cost calculations.'' \712\
---------------------------------------------------------------------------
\709\ Aaron Belkin, Caring for Our Transgender Troops--The
Negligible Cost of Transition-Related Care, 373 New Eng. J. Med.
1089 (2015), https://www.nejm.org/doi/pdf/10.1056/NEJMp1509230?articleTools=true.
\710\ Jody Harman, The Williams Inst., UCLA Sch. of Law, Cost
and Benefits of Providing Transition-Related Health Care Coverage in
Employee Health Benefits Plans: Findings from a Survey of Employers,
p. 2 (Sept. 2013), https://williamsinstitute.law.ucla.edu/wp-content/uploads/Herman-Cost-Benefit-of-Trans-Health-Benefits-Sept-2013.pdf.
\711\ William V. Padula et al., Societal Implications of Health
Insurance Coverage for Medically Necessary Services in the U.S.
Transgender Population: A Cost-Effectiveness Analysis, 31 J. of Ged.
Internal Med. 394 (2015),
\712\ Human Rights Campaign, Corporate Equality Index 2021
(2021), https://reports.hrc.org/corporate-equality-index-2021?_ga=2.206988627.1166715317.1639876655-819100514.1639876655.
---------------------------------------------------------------------------
In recent years, some courts hearing challenges to coverage
exclusions have also considered issues of cost and concluded that
covering gender-transition-related care does not significantly increase
costs for plans. In discussing the parties' experts on the issue of the
cost, one court noted that, ``[f]rom an actuarial perspective, there
appears to be no dispute that the cost of coverage is immaterial.''
\713\ Another court reviewing expert testimony called any cost savings
from excluding coverage for gender-affirming care ``both practically
and actuarially immaterial.'' \714\
---------------------------------------------------------------------------
\713\ Boyden v. Conlin, 341 F. Supp. 3d 979, 1000 (W.D. Wis.
2018).
\714\ Flack v. Wisconsin Dep't of Health Servs., 395 F. Supp. 3d
1001, 1021 (W.D. Wis. 2019); see also Kadel v. Folwell, No. 1:19-cv-
00272, 2022 WL 2106270, at *22 (``in comparison to the [Defendant
state health plan]'s billion-dollar cash balance and saves each of
the Plan's 740,000 members about one dollar each'').
---------------------------------------------------------------------------
Based on the studies discussed above, we estimate that providing
transgender individuals nondiscriminatory insurance coverage and
treatment would have a small impact on the overall cost of care and on
health insurance premiums in terms of the percentage of overall
spending. The utilization rate of newly covered services is likely to
be extremely low because the transgender individuals represent a small
minority in the general population, because not all transgender
individuals will seek medical care in the course of their transition,
and because most entities will provide such care regardless of this
proposed rule (i.e., they will not otherwise have engaged in prohibited
sex discrimination).\715\
---------------------------------------------------------------------------
\715\ State of Cal., Dep't of Ins., supra note 703, at pp. 2, 5.
---------------------------------------------------------------------------
As described in this section, the costs associated with additional
coverage of services are likely to be small on a percentage basis;
however, when these estimates are combined with measures of overall
health care spending, they would likely result in incremental costs
that could be substantial. As an initial estimate, we pair the Belkin
(2015) estimate of 0.012% of incremental health care costs with
$3,931.3 billion in total health consumption expenditures in calendar
year 2020.\716\ Combining these yields our upper-bound estimate of $472
million in annual costs associated with additional coverage. As a
lower-bound estimate, we adopt an assumption that these costs will be
fully offset by reductions in spending on other medical care. This
lower bound of $0 is broadly consistent with a cost-effectiveness
analysis that includes the probability of negative incremental costs
associated with coverage.\717\ For our primary estimate, we start with
the midpoint of the lower-bound and upper-bound cost estimate of about
$236 million annually. We reduce this figure by half to account for
several factors, such as some covered entities already covering
transition-related services under the baseline scenario, whether or not
this is in response to an existing requirement. This results in a
primary estimate of about $118 million per year in incremental annual
costs associated with additional coverage under the proposed rule, with
a full range of cost estimates including $0 million and $472 million.
---------------------------------------------------------------------------
\716\ U.S. Dep't of Health & Human Servs., Ctrs. for Medicare &
Medicaid Servs., Table 1. National Health Expenditures; Aggregate
and Per Capita Amounts, Annual Percent Change and Percent
Distribution: Selected Calendar Years 1960-2020, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NHE-Fact-Sheet (last modified
Dec. 15, 2021, 4:06 p.m.).
\717\ Padula, supra note 711, at 399 fig. 2.
---------------------------------------------------------------------------
[[Page 47904]]
c. Total Quantified Costs
Table 4 below presents the total costs anticipated under the
proposed rule for which estimates have been developed. For the purposes
of this analysis, we assume that the regulatory requirements begin to
take effect at the start of 2024. In the first year under the proposed
rule, these costs include $774.5 million in training and $60.1 million
to revise policies and procedures. For all years in the analysis, we
estimate recurring costs of $39.2 million related to notices. We
estimate a first-year cost of $26.3 million related to documentation,
with ongoing costs in future years of $4.8 million. We also report a
primary cost estimate of $117.9 million associated with expanded
coverage of gender-transition-related care. The total costs in year 1
amount to $1,018.1 million, with ongoing costs of $424.9 million in
subsequent years. Table 3 reports these costs by year, with all
estimates presented in millions of year-2020 dollars.
Table 3--Primary Estimate of Total Annual Costs
[$ millions, 2020 dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost element 2024 2025 2026 2027 2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
Training................................................. $774.5 $258.2 $258.2 $258.2 $258.2
Policies and Procedures.................................. 60.1 0.0 0.0 0.0 0.0
Notices.................................................. 39.2 39.2 39.2 39.2 39.2
Documentation............................................ 26.3 9.6 9.6 9.6 9.6
Expanded Coverage........................................ 117.9 117.9 117.9 117.9 117.9
----------------------------------------------------------------------------------------------
Total Costs.......................................... 1,018.1 424.9 424.9 424.9 424.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
We also identify a cost related to covered entities submitting a
request for an exemption based on Federal conscience or religious
freedom laws. We model this potential cost associated with exemption
requests as the time spent by covered entities to (a) assess the need
for an exemption; (b) write the exemption request; and (c) submit the
exemption request to OCR. As an initial calculation, we assume that
this would involve two (2) employees spending two (2) hours each
assessing the need for an exemption and one employee spending three (3)
hours writing and submitting the exemption request to OCR. We further
assume that legal personnel, including lawyers and legal assistants,
would perform these functions. The mean hourly wage for these
occupations is $63.02 per hour for each employee, which we double to
account for overhead and other costs. We multiply these factors
together and estimate the cost per exemption request of $882.28 ($63.02
x 2 x 7).
OCR receives an average of 428 Section 1557 complaints per year,
covering all areas addressed under the statute and regulations. We
estimate that about a quarter of these are sex discrimination
complaints and anticipate that only a fraction of these correspond to
religiously affiliated covered entities, and that not all of these
complaints would relate to provision or coverage to which religiously
affiliated covered entities would have a religious or conscience
objection. As an initial calculation, we estimate that OCR would
receive fewer than 27 exemption requests (428 x 0.25 x 0.5 x 0.5), and
that these would result in costs to covered entities of $23,601
(multiplying the previous product by $882.28). We include these costs
in our assessment of the likely impacts of the proposed rule, but do
not itemize these costs in Table 3 as they represent a rounding error
compared to other costs we identify. We request public comment on the
assumptions in this calculation.
The proposed rule would also explicitly extend the requirements of
Section 1557 and other civil rights statutes to entities that are
enrolled in Medicare Part B. We are currently unable to quantify the
number of covered entities that are enrolled in Part B but that receive
no other forms of Federal financial assistance. The 2016 Rule discussed
several of the challenges associated with estimating the number of
these entities. For example, the 2016 Rule notes that, ``although we
have data, by program, for the number of physicians receiving payment
from each program, there is no single, unduplicated count of physicians
across multiple programs.'' We tentatively adopt the finding of the
2016 Rule that almost all practicing physicians were likely covered by
the rule because they accept Federal financial assistance from sources
other than Medicare Part B.\718\ We request comment and data on the
number of entities who are enrolled in Medicare Part B but do not
otherwise receive any form of Federal financial assistance.
---------------------------------------------------------------------------
\718\ 81 FR 31375, 31445-46 (May 18, 2016).
---------------------------------------------------------------------------
2. Discussion of Benefits
Quantifying benefits for this proposed rule presents significant
challenges. One notable challenge relates to attribution: several
sources of benefits discussed in the preambles of the 2016 and 2020
Rules overlap with and may be attributable to prior existing civil
rights regulation, to the ACA rather than the 2016 and 2020 rulemakings
that implement Section 1557, or to nondiscrimination policies based on
state law or institutional policies prohibiting discrimination
generally.
A second challenge relates to identifying a quantitative
relationship between nondiscrimination policies and important outcomes
such as improvements in public health outcomes. For example, we
anticipate that this regulation would reduce the incidence of providers
refusing to treat patients based on the patient's gender identity. This
would result in fewer instances of delayed or denied care, which in
turn would lead to reductions in mortality and morbidity risks.
However, we are not able to estimate the changes in the magnitude of
these discriminatory events that would be attributable to the proposed
rule, and thus are unable to quantify or monetize these health
improvements. Similarly, we anticipate that the proposed rule will
result in other sources of benefits that we are unable to quantify.
These include a reduction in suicidal ideation and attempts,
improvements to mental health, reductions in substance use, and
generally align with a discussion of the economic impacts of a
California regulation relating to gender nondiscrimination in health
insurance.\719\ In addition, the prohibition on discrimination through
the use of clinical algorithms is also likely to have a direct benefit
on the health of individuals who are suffering from delayed or denied
medical care
[[Page 47905]]
due to discriminatory clinical algorithms, though we are unable to
quantify this benefit.
---------------------------------------------------------------------------
\719\ State of Cal., Dep't of Ins., supra note 703, at pp. 9-11.
---------------------------------------------------------------------------
These challenges were not resolved in the RIAs associated with the
2016 or 2020 Rules, which only qualitatively reported benefits. We
request comments, including data and quantitative estimates of health
and quality-of-life improvements attributable to nondiscrimination
regulations, that could inform a quantitative analysis, should the
Department finalize this proposed rule.
In addition to these health improvements, we anticipate benefits to
covered entities from additional regulatory clarity on how OCR will
enforce the ACA's nondiscrimination protections, particularly in light
of ongoing litigation related to the 2020 Rule, the Bostock decision,
and the Department's Bostock Notification. The training provisions
represent one mechanism by which the proposed rule would reduce
discriminatory events. This would, in turn, reduce the number of
enforcement actions, representing a potential cost-saving benefit for
covered entities. We also anticipate benefits to covered entities from
the establishment of a grievance process, which would reduce the number
of complaints filed with OCR, though this may be offset somewhat from
covered entities with fewer than 15 employees referring complaints to
OCR in lieu of adopting their own grievance procedure.
We also anticipate benefits to individuals from reduced obstacles
to accessing health care, including fewer language barriers and a
reduction in discriminatory behavior related to sexual orientation and
gender identity. These benefits relate to individuals' ability to
access care and the quality of care they receive. For example, the
provisions related to language access for LEP individuals and
accessibility for individuals with disabilities could reduce instances
of negative outcomes, including death, due to a lack of understanding
between patient and doctor or between patient and pharmacist, as well
as lack of access to services. We also anticipate that the process by
which individuals and recipients may seek an exemption based on Federal
conscience and religious freedom laws will result in benefits from
reduced litigation, which we do not capture in the cost analysis.
3. Analysis of Regulatory Alternatives to the Proposed Rule
The Department considered various alternatives in the course of
developing this regulation. The following are a representative sample
of some of those various alternatives considered.
The Department analyzed several regulatory alternatives to the
proposed rule related to the notice requirements. The first alternative
considered retaining the 2020 Rule repeal of the notices and taglines
provisions. The Department considered concerns raised in response to
the 2016 Rule notice and tagline requirements, as well as concerns
raised in response to the removal of those requirements in the 2020
Rule. Though the Department acknowledges the burden placed on covered
entities through the 2016 Rule notice requirements, the Department
believes the 2020 Rule did not adequately consider the confusion and
uncertainty placed on individuals or the unnecessary ambiguity that
covered entities face by the 2020 Rule's repeal of the notices and
taglines provisions in their entirety. As described earlier, we
estimate that these provisions under the proposed rule would cost
covered entities, as an aggregate, $39.2 million for each year. While
excluding the provisions relating to the notices would reduce the cost
of the proposed rule by $39.2 million, the Department rejected this
option because it believes that the proposed provisions strike an
appropriate balance between providing greater access for beneficiaries
and consumers, while maximizing efficiency and economics of scale for
covered entities.
The second alternative considered by the Department would require
covered entities to provide notices only at their first encounter with
a beneficiary. For this alternative, we adopt the quantity and cost
estimates associated with eligibility and enrollment communication
included in Table 3 above. Under our primary cost scenario, this policy
alternative would result in annual costs of notices of $0.5 million,
which is about $38.6 million lower than the proposed rule. The
Department rejected this option however, because this policy
alternative, while posing a significantly reduced burden on covered
entities, would be too narrow and substantially reduce the information
available to beneficiaries, likely resulting in beneficiaries not being
aware of their civil rights, including whether they have experienced a
prohibited discriminatory practice by a covered entity.
The third alternative considered by the Department would require a
more expansive notice provision, extending the requirements to include
pharmacy-related notices. For this alternative, we adopt the 2020 RIA
estimate of 2.9 billion annual pharmacy-related notices. This would
result in $127.4 million in costs per year, or an increase of $88.2
million compared to the proposed rule. While this alternative related
to notices would increase the number of notices available to
beneficiaries, and therefore increase beneficiaries' opportunity to
receive information regarding nondiscrimination and civil rights
protections, the Department believes this alternative would neither
address nor remedy the burden placed on covered entities through the
2016 Rule notice requirements. For this reason, the Department rejected
this alternative.
Finally, the Department also considered not including a process for
covered entities to submit a request for a religious or conscience
exemption. As described in the cost section, we estimate that this
policy alternative would reduce the quantified costs by $23,601.
Previous Departmental rulemakings have indicated that this policy
alternative could also result in providers with religious and
conscience objections leaving the profession, or covered entities
exiting the market. We request comment on this potential impact,
including any data or studies that provide quantitative evidence that
the Department's May 10, 2021 Bostock Notification ``that the Office
for Civil Rights will interpret and enforce Section 1557 and Title IX's
prohibitions on discrimination based on sex to include: (1)
discrimination on the basis of sexual orientation; and (2)
discrimination on the basis of gender identity''--or subsequent actions
consistent with the Bostock Notification--have resulted in impacts of
this nature.
We have not quantified the benefits associated with this
information for the proposed rule or for these policy alternatives.
Table 4 reports the total costs of these policy alternatives in
present value and annualized terms, adopting a 3% and 7% discount rate.
Table 5 reports the difference between the total cost of the
alternatives compared to the provisions of the proposed rule, using the
same accounting methods and discount rates. All estimates are presented
in millions of year-2020 dollars, using 2024 as the base year for
discounting.
[[Page 47906]]
Table 4--Total Cost of Policy Alternatives Considered
[$ millions, 2020 dollars]
----------------------------------------------------------------------------------------------------------------
Present value Annualized
Accounting method discount rate ---------------------------------------------------------------------------
3% 7% 3% 7%
----------------------------------------------------------------------------------------------------------------
Proposed Rule....................... $2,521.7 $2,296.4 $550.6 $560.1
Alternative 1: No Notice Provision.. 2,342.2 2,135.8 511.4 520.9
Alternative 2: Single Notice 2,344.7 2,138.0 512.0 521.4
Provision..........................
Alternative 3: Pharmacy-Related 2,925.9 2,658.3 638.9 648.3
Notices............................
----------------------------------------------------------------------------------------------------------------
Table 5--Comparison of Alternatives to Proposed Rule
[$ millions, 2020 dollars]
----------------------------------------------------------------------------------------------------------------
Present Value Annualized
Accounting method discount rate ---------------------------------------------------------------------------
3% 7% 3% 7%
----------------------------------------------------------------------------------------------------------------
Alternative 1: No Notice Provision.. -$179.5 -$160.7 -$39.2 -$39.2
Alternative 2: Single Notice -177.0 -158.5 -38.6 -38.6
Provision..........................
Alternative 3: Pharmacy-related 404.1 361.8 88.2 88.2
Notices............................
----------------------------------------------------------------------------------------------------------------
The Department also considered whether to require covered entities
to collect the self-identified race, ethnicity, primary language
(spoken and written), sex, age, and disability status data for
participants, beneficiaries, enrollees, and applicants in any health
program or activity. The Department believes, however, that our current
authorities under Section 1557, Title VI, Section 504, Title IX, and
the Age Act already provide us sufficient ability to collect these
data.
B. Regulatory Flexibility Act--Initial Small Entity Analysis
The Department has examined the economic implications of this
proposed rule as required by the Regulatory Flexibility Act. This
analysis, as well as other sections in this Regulatory Impact Analysis,
serves as the Initial Regulatory Flexibility Analysis, as required
under the Regulatory Flexibility Act.
1. Description and Number of Affected Small Entities
The U.S. Small Business Administration (SBA) maintains a Table of
Small Business Size Standards Matched to North American Industry
Classification System Codes (NAICS).\720\ We replicate the SBA's
description of this table:
---------------------------------------------------------------------------
\720\ U.S. Small Bus. Admin., Table of Size Standards, (last
updated May 2, 2022), https://www.sba.gov/document/support--table-size-standards.
``This table lists small business size standards matched to
industries described in the North American Industry Classification
System (NAICS), as modified by the Office of Management and Budget,
effective January 1, 2017. The latest NAICS codes are referred to as
NAICS 2017.
The size standards are for the most part expressed in either
millions of dollars (those preceded by ``$'') or number of employees
(those without the ``$''). A size standard is the largest that a
concern can be and still qualify as a small business for Federal
Government programs. For the most part, size standards are the
average annual receipts or the average employment of a firm.''
This initial small entity analysis adopts a finding from the 2016
Final Rule that almost all businesses under the scope of the proposed
rule are small businesses. In that analysis, the total small entities
numbered 254,998, which accounts for about 93% of the 275,002 covered
entities under the proposed rule. The covered entities not considered
small businesses include about 10% of physician practices that exceed
the SBA size standard for physicians (excluding mental health
specialists) (North American Industry Classification System code
62111); about 12% of pharmacies that exceed the SBA size standard for
pharmacy and drug store firms (North American Industry Classification
System code 44611); health insurance issuers; and local government
entities.
2. Description of the Potential Impacts of the Rule on Small Entities
The Department generally considers a rule to have a significant
impact on a substantial number of small entities if it has at least a
3% impact on revenue on at least 5% of small entities. We performed a
threshold analysis to determine whether the proposed rule is likely to
exceed these thresholds. As described earlier in this analysis, we
estimate the total annualized costs of the proposed rule would be about
$551 million. Dividing these total costs by the 254,998 small entities
gives a cost per entity of $2,159. This cost estimate would only exceed
the 3% ``significant impact'' threshold on revenue for any covered
small businesses with revenue below $71,978. We tentatively conclude
that very few small businesses covered by the proposed rule have
revenue below $71,978, and that this number is very likely to be
smaller than the 5% ``substantial number'' threshold.
As an additional consideration, we note that the costs of the
proposed rule are mostly proportional to the size of the covered
entity. For example, the costs associated with training, which account
for more than 70% of the total costs of the proposed rule, are
proportional to the number of employees receiving training. In the main
analysis, we estimate an incremental impact of one (1) hour per
employee trained. The opportunity cost of training each employee
represents 0.05% of a full-time employee's annual labor productivity,
assuming a full-time employee works 2,087 hours per year. This finding,
that the cost of training represents 0.05% of the share of employees
receiving training, is constant across firm size.
Because the costs of the proposed rule are small relative to the
revenue of covered entities, including covered small entities, and
because even the smallest affected entities would be unlikely to face a
significant impact, we propose to certify that the proposed rule will
not have a significant economic impact on a substantial number of small
entities.
C. Executive Order 13132: Federalism
As required by E.O. 13132 on Federalism, the Department has
examined the effects of provisions in the
[[Page 47907]]
proposed regulation on the relationship between the Federal Government
and the States. The Department has concluded that the proposed
regulation has Federalism implications but preempts State law only
where the exercise of State authority directly conflicts with the
exercise of Federal authority under the Federal statute.
The proposed regulation attempts to balance State autonomy with the
necessity to create a Federal benchmark that will provide a uniform
level of nondiscrimination protection across the country. The proposed
regulation restricts regulatory preemption of State law to the minimum
level necessary to achieve the objectives of the underlying Federal
statute, Section 1557 of the ACA.
It is recognized that the States generally have laws that relate to
nondiscrimination against individuals on a variety of bases. State laws
continue to be enforceable, unless they prevent application of the
proposed rule. The proposed rule explicitly provides that it is not to
be construed to supersede State or local laws that provide additional
protections against discrimination on any basis articulated under the
regulation. Provisions of State law relating to nondiscrimination that
are ``more stringent'' than the proposed Federal regulatory
requirements or implementation specifications will continue to be
enforceable.
Section 3(b) of E.O. 13132 recognizes that national action limiting
the policymaking discretion of States will be imposed only where there
is constitutional and statutory authority for the action and the
national activity is appropriate in light of the presence of a problem
of national significance. Discrimination issues in relation to health
care are of national concern by virtue of the scope of interstate
health commerce. The ACA's provisions reflect this position.
Section 3(d)(2) of E.O. 13132 requires that where possible, the
Federal Government defer to the States to establish standards. Title I
of the ACA authorized the Secretary to promulgate regulations to
implement Section 1557, and we have done so accordingly.
Section 4(a) of E.O. 13132 expressly contemplates preemption when
there is a conflict between exercising State and Federal authority
under a Federal statute. Section 4(b) of the Executive Order authorizes
preemption of State law in the Federal rule making context when ``the
exercise of State authority directly conflicts with the exercise of
Federal authority under the Federal statute.'' The approach in this
regulation is consistent with these standards in the Executive Order in
superseding State authority only when such authority is inconsistent
with standards established pursuant to the grant of Federal authority
under the statute.
Section 6(b) of E.O. 13132 includes some qualitative discussion of
substantial direct compliance costs that State and local governments
would incur as a result of a proposed regulation. We have determined
that the costs of the proposed rule would not impose substantial direct
compliance costs on State or local governments. We have considered the
cost burden that this proposed rule would impose on State and local
health care and benefit programs, and estimate State and local
government costs will be in the order of $5.7 million in the first two
years of implementation. The $1.9 million represents the sum of the
costs of training State workers and enforcement costs attributable to
State agencies analyzed above.
D. Executive Order 12250 on Leadership and Coordination of
Nondiscrimination Laws
Pursuant to E.O. 12250, the Attorney General has the responsibility
to ``review . . . proposed rules . . . of the Executive agencies''
implementing nondiscrimination statutes such as Section 1557 ``in order
to identify those which are inadequate, unclear or unnecessarily
inconsistent.'' \721\ The Attorney General has delegated that function
to the Assistant Attorney General for the Civil Rights Division for
purposes of reviewing and approving proposed rules, 28 CFR 0.51, and
the Assistant Attorney General has reviewed and approved this proposed
rule.
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\721\ E.O. 12250, sec. 1-202; 45 FR 72995 (Nov. 2, 1980).
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E. Paperwork Reduction Act
This proposed rule contains information collection requirements
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA).\722\ Under the PRA,
agencies are required to submit to OMB for review and approval any
reporting or record-keeping requirements inherent in a proposed or
final rule and are required to publish such proposed requirements for
public comment. The PRA requires agencies to provide a 60-day notice in
the Federal Register and solicit public comment on a proposed
collection of information before it is submitted to OMB for review and
approval. Section 3506(c)(2)(A) of the PRA requires that the Department
solicit comment on the following issues:
---------------------------------------------------------------------------
\722\ 44 U.S.C. 3501 et seq.
---------------------------------------------------------------------------
1. Whether the information collection is necessary and useful to
carry out the proper functions of the agency;
2. The accuracy of the agency's estimate of the information
collection burden;
3. The quality, utility, and clarity of the information to be
collected; and
4. Recommendations to minimize the information collection burden on
the affected public, including automated collection techniques.
The PRA requires consideration of the time, effort, and financial
resources necessary to meet the information collection requirements
referenced in this section. The Department invites public comment on
its assumptions as they relate to the PRA requirements summarized in
this section and explicitly invites comment from potential respondents
regarding the burden estimate we ascribe to these requirements,
including a discussion of respondents' basis for their computation.
The collections of information proposed by this Notice of Proposed
Rulemaking relate to Sec. 92.5 (Assurances required); Sec. 92.7
(Designation and responsibilities of a Section 1557 Coordinator); Sec.
92.8 (Section 1557 Policies and Procedures); Sec. 92.9 (Training);
Sec. 92.10 (Notice of nondiscrimination); and Sec. 92.11 (Notice of
availability of language assistance services and auxiliary aids and
services). Respondents to this proposed information collection would
include a variety of covered entities with a health program or activity
including hospitals, ambulatory surgical centers, skilled nursing
facilities, and physicians' offices. For a more detailed discussion
concerning the potential costs implications related to these proposed
collections of information, please see the Preliminary Economic
Analysis of Impacts directly below.
Proposed Sec. 92.5 retains the assurances obligation from the 2016
and 2020 Rules for covered entities to submit an assurance of
compliance to the Department. OCR has previously obtained PRA approval
(OMB control # 0945-0008) for this reporting requirement via an updated
HHS Form 690 (Consolidated Civil Rights Assurance Form), separate from
this rulemaking. The requirement to sign and submit an assurance of
compliance currently exists under Section 1557 and other civil rights
regulations (Title VI, Section 504, Title IX, and the Age Act). Since
the Department provides an online portal through which covered entities
submit an attestation of
[[Page 47908]]
Assurance of Compliance, the Department has determined that this
requirement imposes no additional reporting or recordkeeping
requirements under the PRA.
Proposed Sec. 92.7 requires covered entities with 15 or more
employees to designate a Section 1557 Coordinator to coordinate their
efforts to comply with and carry out their responsibilities under
Section 1557. The burden to coordinate efforts to comply with and carry
out the responsibilities under Section 1557 is estimated at an
annualized burden of 10 hours per covered entity to store complaints
and the associated records required under proposed Sec. 92.8(c)(2)
each year. We assume that administrative or clerical support personnel
would perform these functions. The mean hourly wage for this occupation
is $17.38 per hour. The Department estimates the number of covered
entities with more than 15 employees to be approximately 15% or 41,250.
We estimate the costs of retaining records related to grievances filed
at all covered entities would be $14.3 million annually ($17.38 x 2 x
10 x 41,250). This estimation approach will overstate the costs if many
covered entities already retain complaint information.
The burden for documenting employee training as required under
proposed Sec. 92.9(c) is the cost of covered entity staff time to (a)
create training attendance forms; and (b) store the training sign-up
sheet. The labor cost would include one (1) employee spending 15
minutes (0.25 hours) to create the sign-up sheet during the first year
and one (1) employee spending one (1) hour collecting and storing the
attendance forms during the first year and subsequent years. We
estimate that administrative or clerical support personnel would
perform these functions. The mean hourly wage for this occupation is
$17.38 per hour. The labor cost is $6.0 million in the first year
(($17.38 x 1.25) x 275,002 covered entities). We estimate that the cost
in subsequent years would be $4.8 million, which would represent an
annual allotment of one (1) hour (($17.38 x 1) x 275,002 covered
entities).
Proposed Sec. 92.10 and Sec. 92.11 require covered entities to
notify the public of their nondiscrimination requirements, as well as
the availability of language assistance services and auxiliary aids and
services.
Proposed Sec. 92.10 requires covered entities to provide a notice
of nondiscrimination relating to its health programs or activities, to
participants, beneficiaries, enrollees, and applicants of its health
programs and activities, and members of the public. To minimize burden
on covered entities, the provision proposes a covered entity may
combine the content of the notice required by this section with the
notice required by Title VI, Section 504, Title IX, and the Age Act
implementing regulations.
Proposed Sec. 92.11 requires covered entities to notify the public
of their nondiscrimination requirements, as well as availability of
language assistance services and auxiliary aids and services. A covered
entity must provide a notice that, at minimum, states that the covered
entity provides language assistance services and auxiliary aids and
services free of charge in its health programs and activities, in
compliance with Section 1557. This notice must be provided to
participants, beneficiaries, enrollees, and applicants of the covered
entity's health program or activity, and members of the public. The
notice must be provided in English and at least the most common 15
languages spoken by LEP individuals of the relevant state or states and
must be provided in alternate formats for individuals with disabilities
who require auxiliary aids and services to ensure effective
communication.
Both types of notices are required (1) on an annual basis; (2) upon
request; (3) at a conspicuous location on the covered entity's health
program or activity website; and (4) in clear and conspicuous physical
locations where the health program or activity interacts with the
public.
The Department estimates the burden for responding to the proposed
notice requirement would be 34 minutes and that administrative or
clerical support personnel would perform these functions. Because it is
difficult to determine the exact number of communications which would
be required to contain the notices anticipated under the proposed rule,
our cost estimates reflect a wide range of uncertainty in the cost. The
Department estimates an adjusted annual primary costs total of $4.5
million, with a range of costs between $2.7 million and $25.0 million.
These costs would occur in each year of the time horizon of the
analysis.
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\723\ The figures in this column are averages based on a range.
Small entities may require fewer hours to conduct certain compliance
activities, while large entities may require more hours than those
provided here due to their size and complexity.
\724\ Covered entities with 15 or more employees would be
required to coordinate the retention of grievance complaints for no
less than three years. We have estimated that this provision would
apply to approximately 41,250 covered entities. All covered entities
would be required to document employee training on Section 1557. We
estimated that this would apply to approximately 275,002 covered
entities.
\725\ We have estimated that covered entities with 15 or more
employees would spend approximately 10 hours on efforts to
coordinate their compliance efforts under Section 1557 as required
under Sec. 92.7. We estimate that all covered entities would spend
approximately 1.25 hours documenting employee training as required
under Sec. 92.9.
\726\ Because it is difficult to determine the exact number of
communications which would be required to contain the notices
anticipated under the proposed rule, our number of responses per
respondent estimate reflects this uncertainty. The Department
invites potential respondents to comment on its assumption regarding
number of responses per respondent and the ultimate burden estimate
we ascribe to this requirement, including a discussion of
respondents' basis for their computation.
Table 1--Proposed Annual Burden of Response in Year One/Subsequent Years Following Publication of the Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total annual
Regulation burden Type of respondent respondents responses per responses hours burden
respondent response (hours) \723\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 92.7 Coordination Efforts....... Covered entities with 15 \724\ 41,250/275,002 1 316,252 \725\ 10/1.25 756,252
or more employees/all
covered entities.
Sec. 92.10 & Sec. 92.11 Notice..... All covered entities..... 275,002 \726\ 1 275,002 34/60 93,501
-------------------------------------------------------------------------------------
Total Annual Burden Hours.......... ......................... .................... .............. .............. .............. 849,753
--------------------------------------------------------------------------------------------------------------------------------------------------------
* The figures in this column are averages based on a range. Small entities may require fewer hours to conduct certain compliance activities, while large
entities may require more hours than those provided here due to their size and complexity.
** We monetize the time spent on revising policies and procedures, depending on the extent of the revisions. For the 137,501 covered entities with less
extensive revisions, we estimate two (2) total hours spent on revisions per entity. For the 137,501 covered entities with more extensive revisions, we
estimate four (4) total hours spent on revision per entity.
[[Page 47909]]
*** Because it is difficult to determine the exact number of communications which would be required to contain the notices anticipated under the
proposed rule, our number of responses per respondent estimate reflects this uncertainty. The Department invites potential respondents to comment on
its assumption regarding a number of responses per respondent and the ultimate burden estimate we ascribe to this requirement, including a discussion
of respondents' basis for their computation.
VII. Request for Comment
The Department seeks comment on all issues raised by the proposed
regulation. Specifically, in addition to issues on which it has already
requested comments above, the Department requests comment on:
The financial impact of the proposed rule on the health
care sector, with any detailed supporting information, facts, surveys,
audits, or reports;
Whether the application of this rule to health programs
and activities that receive Federal funding, to health programs and
activities of executive agencies, and to all programs and activities of
executive agencies should be considered in a different manner;
Whether, and if so how, the proposed rule addresses
clarity and confusion over compliance requirements and rights of people
to be free from discrimination on protected bases;
Whether covered entities that employ fewer than 15 people
should be required to have a Section 1557 Coordinator and grievance
procedures, and any benefits and burdens associated with such a
requirement;
Whether, and if so how, new and developing technologies
can assist covered entities with their compliance obligations and
enhance access to quality health care;
The costs to provide the notice of nondiscrimination and
the Notice of Availability and the impact of such notices on the
utilization of language assistance services for LEP individuals and
auxiliary aids and services for individuals with disabilities with any
detailed supporting information, facts, surveys, audits, or reports;
Whether the list of communications that require a Notice
of Availability captures those most critical for LEP individuals and
individuals with disabilities, and any detailed supporting information,
facts, surveys, audits, or reports pertaining to the benefit of such
notices or the related cost of their inclusion in the listed
communications;
Whether standards set pursuant to Section 510 of the
Rehabilitation Act on ensuring the availability of accessible medical
diagnostic equipment, should be incorporated as an enforceable standard
for covered entities into the proposed rule for purposes of Section
1557;
How best to address challenges accessing accessible
medical diagnostic equipment and whether lack of access to such
equipment constitutes discriminatory benefit design or network
inadequacy;
Whether Section 1557 should include a provision requiring
covered entities to comply with specific accessibility standards for
web content such as Section 508 standards, the WCAG 2.0 standards, the
WCAG 2.1 standards, or other standards that provide equal or greater
accessibility to individuals with disabilities. Additionally, OCR seeks
comments on whether to adopt a safe harbor provision under which
covered entities that are in compliance with established specific
accessibility standards are deemed in compliance with proposed Sec.
92.204; whether OCR should require covered entities to comply with the
most recent edition of a published standard; and the timeline necessary
for covered entities to come into compliance with a new standard.
What steps the Department can take to assist covered
entities in meeting their language access and effective communication
responsibilities, such that these services are provided in the most
efficient and effective manner for participants, beneficiaries,
enrollees, and applicants of covered health programs and activities.
Unaddressed discrimination on the basis of race, color,
national origin (including limited English proficiency and primary
language), sex (including pregnancy, sexual orientation, gender
identity, and sex characteristics), age, and disability as applied to
State and Federally-facilitated Exchanges, with any detailed supporting
information, facts, surveys, audits, or reports; and
Whether covered entities seek guidance on best practices
for compliance with Section 1557, and on what topics.
List of Subjects
42 CFR Part 438
Civil rights, Discrimination, Grant programs--health, Individuals
with disabilities, Medicaid, National origin, Nondiscrimination,
Reporting and recordkeeping requirements, Sex discrimination.
42 CFR Part 440
Civil rights, Discrimination, Grant programs--health, Individuals
with disabilities, Medicaid, National origin, Nondiscrimination, Sex
discrimination.
42 CFR Part 457
Civil rights, Discrimination, Grant programs--health, Individuals
with disabilities, Medicaid, National origin, Nondiscrimination, Sex
discrimination.
42 CFR Part 460
Age discrimination, Aged, Civil rights, Discrimination, Health,
Individuals with disabilities, Medicare, Medicaid, National origin,
Nondiscrimination, Religious discrimination, Reporting and
recordkeeping requirements, Sex discrimination.
45 CFR Part 80
Administrative practice and procedure, Civil rights,
Discrimination, Medicare, Nondiscrimination.
45 CFR Part 84
Administrative practice and procedure, Civil rights,
Discrimination, Individuals with disabilities, Medicare,
Nondiscrimination.
45 CFR Part 86
Administrative practice and procedure, Civil rights,
Discrimination, Education, Medicare, Nondiscrimination, Sex
discrimination.
45 CFR Part 91
Administrative practice and procedure, Civil rights,
Discrimination, Elderly, Medicare, Nondiscrimination.
45 CFR Part 92
Administrative practice and procedure, Civil rights,
Discrimination, Elderly, Health care, Health facilities, Health
insurance, Health programs and activities, Individuals with
disabilities, Medicare, Nondiscrimination, Reporting and recordkeeping
requirements, Sex discrimination.
45 CFR Part 147
Aged, Citizenship and naturalization, Civil rights, Health care,
Health insurance, Individuals with disabilities, Intergovernmental
relations, Reporting and recordkeeping requirements, Sex
discrimination.
45 CFR Part 155
Administrative practice and procedure, Advertising, Aged, Brokers,
Citizenship and naturalization, Civil rights, Conflict of interests,
Consumer protection, Grant programs-health, Grants administration,
Health care, Health insurance, Health maintenance organizations (HMO),
Health records,
[[Page 47910]]
Hospitals, Indians, Individuals with disabilities, Intergovernmental
relations, Loan programs-health, Medicaid, Organization and functions
(Government agencies), Public assistance programs, Reporting and
recordkeeping requirements, Sex discrimination, State and local
governments, Taxes, Technical assistance, Women, Youth.
45 CFR Part 156
Administrative practice and procedure, Advertising, Advisory
committees, Brokers, Conflict of interests, Consumer protection, Grant
programs-health, Grants administration, Health care, Health insurance,
Health maintenance organization (HMO), Health records, Hospitals,
Indians, Individuals with disabilities, Loan programs-health, Medicaid,
Organization and functions (Government agencies), Public assistance
programs, Reporting and recordkeeping requirements, State and local
governments, Sunshine Act, Technical assistance, Women, Youth.
For the reasons set forth in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR parts 438, 440, 457, and
460 and 45 CFR parts 80, 84, 92, 147, 155, and 156 as follows:
Title 42--Public Health
PART 438--MANAGED CARE
0
1. The authority citation for part 438 continues to read as follows:
Authority: 42 U.S.C. 1302.
0
2. Amend Sec. 438.3 by revising paragraph (d)(4) to read as follows:
Sec. 438.3 Standard contract requirements.
* * * * *
(d) * * *
(4) The MCO, PIHP, PAHP, PCCM or PCCM entity will not discriminate
against individuals eligible to enroll on the basis of race, color,
national origin, sex (including sexual orientation and gender
identity), or disability and will not use any policy or practice that
has the effect of discriminating on the basis of race, color, national
origin, sex (sexual orientation and gender identity), or disability.
* * * * *
0
3. Amend Sec. 438.206 by revising paragraph (c)(2) to read as follows:
Sec. 438.206 Availability of services.
* * * * *
(c) * * *
(2) Access and cultural considerations. Each MCO, PIHP, and PAHP
participates in the State's efforts to promote the delivery of services
in a culturally competent manner to all enrollees, including those with
limited English proficiency and diverse cultural and ethnic
backgrounds, disabilities, and regardless of sex (including sexual
orientation and gender identity).
* * * * *
PART 440--SERVICES: GENERAL PROVISIONS
0
4. The authority citation for part 440 continues to read as follows:
Authority: 42 U.S.C. 1302.
0
5. Revise Sec. 440.262 to read as follows:
Sec. 440.262 Access and cultural conditions.
The State must have methods to promote access and delivery of
services in a culturally competent manner to all beneficiaries,
including those with limited English proficiency, diverse cultural and
ethnic backgrounds, disabilities, and regardless of sex (including
sexual orientation and gender identity). These methods must ensure that
beneficiaries have access to covered services that are delivered in a
manner that meets their individualized needs.
PART 457--ALLOTMENTS AND GRANTS TO STATES
0
6. The authority citation for part 457 continues to read as follows:
Authority: Section 1102 of the Social Security Act (42 U.S.C.
1302).
0
7. Section 457.495 is amended by adding paragraph (e) to read as
follows:
Sec. 457.495 State assurance of access to care and procedures to
assure quality and appropriateness of care.
* * * * *
(e) Access to and delivery of services in a culturally competent
manner to all beneficiaries, as described in 42 CFR 440.262.
PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
0
8. The authority citation for part 460 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395l, 1395eee(f), and 1396u-4(f).
0
9. Amend Sec. 460.98 by revising paragraph (b)(3) to read as follows:
Sec. 460.98 Service delivery.
* * * * *
(b) * * *
(3) The PACE organization may not discriminate against any
participant in the delivery of required PACE services based on race,
ethnicity, national origin, religion, sex (including sexual orientation
and gender identity), age, mental or physical disability, or source of
payment.
* * * * *
0
10. Amend Sec. 460.112 by revising paragraph (a) introductory text to
read as follows:
Sec. 460.112 Specific rights to which a participant is entitled.
(a) Respect and nondiscrimination. Each participant has the right
to considerate, respectful care from all PACE employees and contractors
at all times and under all circumstances. Each participant has the
right not to be discriminated against in the delivery of required PACE
services based on race, ethnicity, national origin, religion, sex
(including sexual orientation and gender identity), age, mental or
physical disability, or source of payment. Specifically, each
participant has the right to the following:
* * * * *
Title 45--Public Health
PART 80--NONDISCRIMINATION UNDER PROGRAMS RECEIVING FEDERAL
ASSISTANCE THROUGH THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
EFFECTUATION OF TITLE VI OF THE CIVIL RIGHTS ACT OF 1964
0
11. The authority citation for part 80 continues to read as follows:
Authority: Sec. 602, 78 Stat. 252; 42 U.S.C. 2000d-1.
0
12. Amend part 1 of appendix A to part 80 by adding paragraph 155 to
read as follows:
Appendix A to Part 80--Federal Financial Assistance to Which These
Regulations Apply
Part 1 * * *
0
155. Supplementary medical insurance benefits for the aged (Title
XVIII, Part B, Social Security Act, 42 U.S.C. 1395j-1395w-6).
* * * * *
PART 84--NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR
ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE
0
13. The authority citation for part 84 continues to read as follows:
Authority: 20 U.S.C. 1405; 29 U.S.C. 794; 42 U.S.C. 290dd-2; 21
U.S.C. 1174.
Appendix A to Part 84 [Amended]
0
14. Amend appendix A to part 84 under subpart a by removing the third
[[Page 47911]]
paragraph in ``2. Federal financial assistance''.
0
15. Revise part 92 to read as follows:
PART 92--NONDISCRIMINATION IN HEALTH PROGRAMS OR ACTIVITIES
Subpart A--General Provisions
Sec.
92.1 Purpose and applicability date.
92.2 Application.
92.3 Relationship to other laws.
92.4 Definitions.
92.5 Assurances required.
92.6 Remedial action and voluntary action.
92.7 Designation and responsibilities of a Section 1557 Coordinator.
92.8 Policies and procedures.
92.9 Training.
92.10 Notice of nondiscrimination.
92.11 Notice of availability of language assistance services and
auxiliary aids and services.
Subpart B--Nondiscrimination Provisions
92.101 Discrimination prohibited.
Subpart C--Specific Applications to Health Programs and Activities.
92.201 Meaningful access for limited English proficient individuals.
92.202 Effective communication for individuals with disabilities.
92.203 Accessibility for buildings and facilities.
92.204 Accessibility of information and communication technology for
individuals with disabilities.
92.205 Requirement to make reasonable modifications.
92.206 Equal program access on the basis of sex.
92.207 Nondiscrimination in health insurance and other health-
related coverage.
92.208 Prohibition on sex discrimination related to marital,
parental, or family status.
92.209 Nondiscrimination on the basis of association.
92.210 Nondiscrimination in the use of clinical algorithms in
decision-making.
92.211 Nondiscrimination in the delivery of health programs and
activities through telehealth services.
Subpart D--Procedures
92.301 Enforcement mechanisms.
92.302 Notification of views regarding application of Federal
conscience and religious freedom laws.
92.303 Procedures for health programs and activities conducted by
recipients and State Exchanges.
92.304 Procedures for health programs and activities administered by
the Department.
Authority: 42 U.S.C. 18116
Subpart A--General Provisions
Sec. 92.1 Purpose and applicability date.
(a) Purpose. The purpose of this part is to implement Section 1557
of the Patient Protection and Affordable Care Act (ACA) (42 U.S.C.
18116), which prohibits discrimination on the basis of race, color,
national origin, sex, age, and disability in certain health programs
and activities. Section 1557 provides that, except as otherwise
provided in Title I of the ACA, an individual shall not, on the grounds
prohibited under Title VI of the Civil Rights Act of 1964, Title IX of
the Education Amendments of 1972, the Age Discrimination Act of 1975,
or Section 504 of the Rehabilitation Act of 1973, be excluded from
participation in, be denied the benefits of, or be subjected to
discrimination under, any health program or activity, any part of which
is receiving Federal financial assistance, including credits,
subsidies, or contracts of insurance, or under any program or activity
that is administered by an Executive Agency or any entity established
under Title I of the ACA. This part applies to health programs or
activities administered by recipients of Federal financial assistance
from the Department, Department-administered health programs or
activities, and Title I entities that administer health programs or
activities.
(b) Applicability date. The regulations in this part are applicable
beginning [DATE 60 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE],
except to the extent that provisions of this part require changes to
health insurance or group health plan benefit design (including covered
benefits, benefit limitations or restrictions, and cost-sharing
mechanisms, such as coinsurance, copayments, and deductibles); such
provisions, as they apply to health insurance or group health plan
benefit design, have an applicability date of the first day of the
first plan year (in the individual market, policy year) beginning on or
after [DATE ONE YEAR AFTER EFFECTIVE DATE OF FINAL RULE].
Sec. 92.2 Application.
(a) Except as otherwise provided in this part, this part shall
apply to:
(1) Every health program or activity, any part of which receives
Federal financial assistance, directly or indirectly, from the
Department;
(2) Every health program or activity administered by the
Department; and
(3) Every program or activity administered by a Title I entity.
(b) The provisions of this part shall not apply to any employer
with regard to its employment practices, including the provision of
employee health benefits.
(c) Any provision of this part held to be invalid or unenforceable
by its terms, or as applied to any person or circumstance, shall be
severable from this part and shall not affect the remainder thereof or
the application of the provision to other persons not similarly
situated or to other, dissimilar circumstances.
Sec. 92.3 Relationship to other laws.
(a) Neither section 1557 nor this part shall be construed to apply
a lesser standard for the protection of individuals from discrimination
than the standards applied under Title VI of the Civil Rights Act of
1964, Title IX of the Education Amendments of 1972, Section 504 of the
Rehabilitation Act of 1973, the Age Discrimination Act of 1975, or the
regulations issued pursuant to those laws.
(b) Nothing in this part shall be construed to invalidate or limit
the rights, remedies, procedures, or legal standards available under
Title VI of the Civil Rights Act of 1964, Title VII of the Civil Rights
Act of 1964, Title IX of the Education Amendments of 1972, Section 504
of the Rehabilitation Act of 1973, or the Age Discrimination Act of
1975.
(c) Nothing in this part shall be construed to invalidate or limit
the rights, remedies, procedures, or legal standards available to
individuals under Federal conscience or religious freedom laws.
Sec. 92.4 Definitions.
As used in this part, the term--
1991 Standards means the 1991 ADA Standards for Accessible Design,
published at Appendix A to 28 CFR part 36 on July 26, 1991, and
republished as Appendix D to 28 CFR part 36 on September 15, 2010.
2010 Standards means the 2010 ADA Standards for Accessible Design,
as defined at 28 CFR 35.104.
ACA means the Patient Protection and Affordable Care Act (Pub. L.
111-148, 124 Stat. 119 (2010) as amended by the Health Care and
Education Reconciliation Act of 2010 (Pub. L. 111-152, 124 Stat. 1029)
(codified in scattered sections of U.S.C.)).
ADA means the Americans with Disabilities Act of 1990 (42 U.S.C.
12101 et seq.), as amended.
Age means how old a person is, or the number of elapsed years from
the date of a person's birth.
Age Act means the Age Discrimination Act of 1975 (42 U.S.C. 6101 et
seq.), as amended.
Applicant means a person who applies to participate in a health
program or activity.
Auxiliary aids and services include, for example:
(1) Qualified interpreters on-site or through video remote
interpreting (VRI)
[[Page 47912]]
services, as defined in 28 CFR 35.104 and 36.303(b); note takers; real-
time computer-aided transcription services; written materials; exchange
of written notes; telephone handset amplifiers; assistive listening
devices; assistive listening systems; telephones compatible with
hearing aids; closed caption decoders; open and closed captioning,
including real-time captioning; voice, text, and video-based
telecommunications products and systems, including text telephones
(TTYs), videophones, and captioned telephones, or equally effective
telecommunications devices; videotext displays; accessible information
and communication technology (ICT); or other effective methods of
making aurally delivered information available to persons who are deaf
or hard of hearing;
(2) Qualified readers; taped texts; audio recordings; Braille
materials and displays; screen reader software; magnification software;
optical readers; secondary auditory programs (SAP); large print
materials; accessible information and communication technology; or
other effective methods of making visually delivered materials
available to persons who are blind or have low vision;
(3) Acquisition or modification of equipment and devices; and
(4) Other similar services and actions.
Companion means a family member, friend, or associate of an
individual seeking access to a service, program or activity of a
covered entity, who along with such individual, is an appropriate
person with whom a covered entity should communicate.
Covered entity means:
(1) A recipient of Federal financial assistance;
(2) The Department; and
(3) An entity established under Title I of the ACA.
Department means the U.S. Department of Health and Human Services.
Director means the Director of the Office for Civil Rights (OCR) of
the Department, or their designee(s).
Disability means, with respect to a person, a physical or mental
impairment that substantially limits one or more major life activities
of such person; a record of such an impairment; or being regarded as
having such an impairment, as defined and construed in the
Rehabilitation Act, 29 U.S.C. 705(9)(B), which incorporates the
definition of disability in the ADA, 42 U.S.C. 12102, as amended and
adopted at 28 CFR 35.108.
Exchange means the same as ``Exchange'' defined in 45 CFR 155.20.
Federal financial assistance. (1) Federal financial assistance
means any grant, loan, credit, subsidy, contract (other than a
procurement contract but including a contract of insurance), or any
other arrangement by which the Federal Government, directly or
indirectly, provides assistance or otherwise makes assistance available
in the form of:
(i) Funds;
(ii) Services of Federal personnel; or
(iii) Real or personal property or any interest in or use of such
property, including:
(A) Transfers or leases of such property for less than fair market
value or for reduced consideration; and
(B) Proceeds from a subsequent transfer or lease of such property
if the Federal share of its fair market value is not returned to the
Federal Government.
(2) Federal financial assistance the Department provides or
otherwise makes available includes Federal financial assistance that
the Department plays a role in providing or administering, including
advance payments of the premium tax credit and cost-sharing reduction
payments under Title I of the ACA, as well as payments, subsidies, or
other funds extended by the Department to any entity providing health
insurance coverage for payment to or on behalf of a person obtaining
health insurance coverage from that entity or extended by the
Department directly to such person for payment to any entity providing
health insurance coverage.
Federally-facilitated Exchange means the same as ``Federally-
facilitated Exchange'' defined in 45 CFR 155.20.
Health program or activity means:
(1) Any project, enterprise, venture, or undertaking to
(i) Provide or administer health-related services, health insurance
coverage, or other health-related coverage;
(ii) Provide assistance to persons in obtaining health-related
services, health insurance coverage, or other health-related coverage;
(iii) Provide clinical, pharmaceutical, or medical care;
(iv) Engage in health research; or
(v) Provide health education for health care professionals or
others;
(2) All of the operations of any entity principally engaged in the
provision or administration of any health projects, enterprises,
ventures, or undertakings described in paragraph (1) of this
definition, including, but not limited to, a State or local health
agency, hospital, health clinic, health insurance issuer, physician's
practice, pharmacy, community-based health care provider, nursing
facility, residential or community-based treatment facility, or other
similar entity or combination thereof.
Information and communication technology (ICT) means information
technology and other equipment, systems, technologies, or processes,
for which the principal function is the creation, manipulation,
storage, display, receipt, or transmission of electronic data and
information, as well as any associated content. Examples of ICT
include, but are not limited to: computers and peripheral equipment;
information kiosks and transaction machines; telecommunications
equipment; telehealth interfaces or applications; customer premises
equipment; multifunction office machines; software; mobile
applications; websites; videos; and electronic documents.
Language assistance services may include, but are not limited to:
(1) Oral language assistance, including interpretation in non-
English languages provided in-person or remotely by a qualified
interpreter for a limited English proficient individual, and the use of
qualified bilingual or multilingual staff to communicate directly with
limited English proficient individuals;
(2) Written translation, performed by a qualified translator, of
written content in paper or electronic form into or from languages
other than English; and
(3) Written notice of availability of language assistance services.
Limited English proficient individual means an individual whose
primary language for communication is not English and who has a limited
ability to read, write, speak, or understand English. A limited English
proficient individual may be competent in English for certain types of
communication (e.g., speaking or understanding), but still be limited
English proficient for other purposes (e.g., reading or writing).
Machine translation means automated translations, without the
assistance of or review by a qualified human translator, that is text-
based and provides instant translations between various languages,
sometimes with an option for audio input or output.
National origin includes, but is not limited to, a person's, or
their ancestor's, place of origin (such as country or world region) or
a person's manifestation of the physical, cultural, or linguistic
characteristics of a national origin group.
OCR means the Office for Civil Rights of the Department.
Qualified bilingual/multilingual staff means a member of a covered
entity's
[[Page 47913]]
workforce who is designated by the covered entity to provide in-
language oral language assistance as part of the person's current,
assigned job responsibilities and who has demonstrated to the covered
entity that they are:
(1) Proficient in speaking and understanding both spoken English
and at least one other spoken language, including any necessary
specialized vocabulary, terminology and phraseology; and
(2) Able to effectively, accurately, and impartially communicate
directly with limited English proficient individuals in their primary
languages.
Qualified individual with a disability means an individual with a
disability who, with or without reasonable modifications to rules,
policies, or practices, the removal of architectural, communication, or
transportation barriers, or the provision of auxiliary aids and
services, meets the essential eligibility requirements for the receipt
of services or the participation in programs or activities provided by
the covered entity.
Qualified interpreter for an individual with a disability means an
interpreter who, via a video remote interpreting service (VRI) or an
on-site appearance, is able to interpret effectively, accurately, and
impartially, both receptively and expressively, using any necessary
specialized vocabulary. Qualified interpreters include, for example,
sign language interpreters, oral transliterators, and cued-language
transliterators.
Qualified interpreter for a limited English proficient individual
means an interpreter who via a remote interpreting service or an on-
site appearance:
(1) Has demonstrated proficiency in speaking and understanding both
spoken English and at least one other spoken language;
(2) Is able to interpret effectively, accurately, and impartially
to and from such language(s) and English, using any necessary
specialized vocabulary or terms without changes, omissions, or
additions and while preserving the tone, sentiment, and emotional level
of the original oral statement; and
(3) Adheres to generally accepted interpreter ethics principles,
including client confidentiality.
Qualified reader means a person who is able to read effectively,
accurately, and impartially using any necessary specialized vocabulary.
Qualified translator means a translator who:
(1) Has demonstrated proficiency in writing and understanding both
written English and at least one other written non-English language;
(2) Is able to translate effectively, accurately, and impartially
to and from such language(s) and English, using any necessary
specialized vocabulary or terms without changes, omissions, or
additions and while preserving the tone, sentiment, and emotional level
of the original written statement; and
(3) Adheres to generally accepted translator ethics principles,
including client confidentiality.
Recipient means any State or its political subdivision thereof; or
any instrumentality of a State or political subdivision thereof; any
public or private agency, institution, or organization, or other
entity, or any person, to whom Federal financial assistance is extended
directly or indirectly, including any subunit, successor, assignee, or
transferee of a recipient. Such term does not include any ultimate
beneficiary.
Section 504 means Section 504 of the Rehabilitation Act of 1973
(Pub. L. 93-112; 29 U.S.C. 794), as amended.
Section 1557 means Section 1557 of the ACA (42 U.S.C. 18116).
State Exchange means an Exchange established by a State and
approved by the Department pursuant to 45 CFR part 155, subpart B.
Title I entity means any entity established under Title I of the
ACA, as amended, including State Exchanges and Federally-facilitated
Exchanges.
Title VI means Title VI of the Civil Rights Act of 1964 (Pub. L.
88-352; 42 U.S.C. 2000d et seq.), as amended.
Title VII means Title VII of the Civil Rights Act of 1964 (Pub. L.
88-352; 42 U.S.C. 2000e et seq.), as amended.
Title IX means Title IX of the Education Amendments of 1972 (Pub.
L. 92-318; 20 U.S.C. 1681 et seq.), as amended.
Sec. 92.5 Assurances required.
(a) Assurances. An entity applying for Federal financial assistance
to which this part applies must, as a condition of any application for
Federal financial assistance, submit an assurance, on a form specified
by the Director, that the entity's health programs and activities will
be operated in compliance with Section 1557 and this part. A health
insurance issuer seeking certification to participate in an Exchange or
a State seeking approval to operate a State Exchange to which Section
1557 or this part applies must, as a condition of certification or
approval, submit an assurance, on a form specified by the Director,
that the health insurance issuer's or State's health program or
activity will be operated in compliance with Section 1557 and this
part. An applicant or entity may incorporate this assurance by
reference in subsequent applications to the Department for Federal
financial assistance or requests for certification to participate in an
Exchange or approval to operate a State Exchange.
(b) Duration of obligation. The duration of the assurances required
by this section is the same as the duration of the assurances required
in the Department's regulations implementing Section 504, 45 CFR
84.5(b).
(c) Covenants. When Federal financial assistance is provided in the
form of real property or interest, the same conditions apply as those
contained in the Department's regulations implementing Section 504, at
45 CFR 84.5(c), except that the nondiscrimination obligation applies to
discrimination on all bases covered under Section 1557 and this part.
Sec. 92.6 Remedial action and voluntary action.
(a) Remedial action. (1) If the Director finds that a recipient or
State Exchange has discriminated against an individual on the basis of
race, color, national origin, sex, age, or disability, in violation of
Section 1557 or this part, such recipient or State Exchange must take
such remedial action as the Director may require to overcome the
effects of the discrimination.
(2) Where a recipient is found to have discriminated against an
individual on the basis of race, color, national origin, sex, age, or
disability, in violation of Section 1557 or this part, and where
another recipient exercises control over the recipient that has
discriminated, the Director, where appropriate, may require either or
both entities to take remedial action.
(3) The Director may, where necessary to overcome the effects of
discrimination in violation of Section 1557 or this part, require a
recipient, in its health programs and activities, or State Exchange to
take remedial action with respect to:
(i) Persons who are no longer participants in the recipient's or
State Exchange's health program or activity but who were participants
in the health program or activity when such discrimination occurred; or
(ii) Persons who would have been participants in the health program
or activity had the discrimination not occurred.
(b) Voluntary action. A covered entity may take nondiscriminatory
steps, in addition to any action that is required by Section 1557 or
this part, to overcome the effects of conditions that
[[Page 47914]]
result or resulted in limited participation in the covered entity's
health programs or activities by persons on the basis of race, color,
national origin, sex, age, or disability.
Sec. 92.7 Designation and responsibilities of a Section 1557
Coordinator.
(a) Section 1557 Coordinator and designees. A covered entity that
employs fifteen or more persons must designate and authorize at least
one employee, referred to herein as ``Section 1557 Coordinator,'' to
coordinate the covered entity's compliance with its responsibilities
under Section 1557 and this part in its health programs and activities,
including the investigation of any grievance communicated to it
alleging noncompliance with Section 1557 or this part or alleging any
action that would be prohibited by Section 1557 or this part. As
appropriate, a covered entity may assign one or more designees to carry
out some of these responsibilities, but the Section 1557 Coordinator
must retain ultimate oversight for ensuring coordination with the
covered entity's compliance with this part.
(b) Responsibilities of a Section 1557 Coordinator. A covered
entity must ensure that, at minimum, the Section 1557 Coordinator:
(1) Receives, reviews, and processes grievances, filed under the
grievance procedure as set forth in Sec. 92.8(c);
(2) Coordinates the covered entity's recordkeeping requirements as
set forth in Sec. 92.8(c);
(3) Coordinates effective implementation of the covered entity's
language access procedures as set forth in Sec. 92.8(d);
(4) Coordinates effective implementation of the covered entity's
effective communication procedures as set forth in Sec. 92.8(e);
(5) Coordinates effective implementation of the covered entity's
reasonable modification procedures as set forth in Sec. 92.8(f); and
(6) Coordinates training of relevant employees as set forth in
Sec. 92.9 of this part, including maintaining documentation required
by such section.
Sec. 92.8 Policies and procedures.
(a) General requirement. A covered entity must implement written
policies and procedures in its health programs and activities that are
designed to comply with the requirements of this part. The policies and
procedures must include an effective date and be reasonably designed,
taking into account the size, complexity, and the type of health
programs or activities undertaken by a covered entity, to ensure
compliance with this part.
(b) Nondiscrimination policy. A covered entity must implement a
written policy in its health programs and activities that, at minimum,
states the covered entity does not discriminate on the basis of race,
color, national origin (including limited English proficiency and
primary language), sex (including pregnancy, sexual orientation, gender
identity, and sex characteristics), age, or disability; that the
covered entity provides language assistance services and appropriate
auxiliary aids and services free of charge, when necessary for
compliance with Section 1557 or this part; that the covered entity will
provide reasonable modifications for individuals with disabilities; and
provides the contact information for the Section 1557 Coordinator
required by Sec. 92.7 (if applicable).
(c) Grievance procedures. (1) A covered entity that employs fifteen
or more persons must implement written grievance procedures in its
health programs and activities that provide for the prompt and
equitable resolution of grievances alleging any action that would be
prohibited by Section 1557 or this part.
(2) A covered entity to which this paragraph applies must retain
records related to grievances filed with it that allege discrimination
on the basis of race, color, national origin, sex, age, or disability
for no less than three (3) calendar years from the date of the filing
of the grievance. The records must include the grievance; the name and
contact information of the complainant (if provided by complainant);
the alleged discriminatory action and alleged basis (or bases) of
discrimination; the date the grievance was filed; grievance resolution;
and any other pertinent information.
(3) A covered entity to which this paragraph applies must keep
confidential the identity of an individual who has filed a grievance
under this part except as required by law or to the extent necessary to
carry out the purposes of this part, including the conduct of any
investigation.
(d) Language access procedures. A covered entity must implement
written language access procedures in its health programs and
activities describing the covered entity's process for providing
language assistance services to limited English proficient individuals
when required under Sec. 92.201 of this part. At a minimum, the
language access procedures must include current information detailing
the contact information for the Section 1557 Coordinator (if
applicable); how an employee identifies whether an individual is
limited English proficient; how an employee obtains the services of
qualified interpreters and translators the covered entity uses to
communicate with a limited English proficient individual; the names of
any qualified bilingual staff members; and a list and the location of
any electronic and written translated materials the covered entity has
and the languages they are translated into, and the publication date.
(e) Effective communication procedures. A covered entity must
implement written effective communication procedures in its health
programs and activities describing the covered entity's process for
ensuring effective communication for individuals with disabilities when
required under Sec. 92.202. At a minimum, a covered entity's effective
communication procedures must include current contact information for
the Section 1557 Coordinator (if applicable); how an employee obtains
the services of qualified interpreters the covered entity uses to
communicate with individuals with disabilities, including the names of
any qualified interpreter staff members, and how to access appropriate
auxiliary aids and services.
(f) Reasonable modification procedures. A covered entity must
implement written procedures in its health programs and activities
describing its process for making reasonable modifications to its
policies, practices, or procedures when necessary to avoid
discrimination on the basis of disability as required under Sec.
92.205. At a minimum, the reasonable modification procedures must
include contact information for the covered entity's Section 1557
Coordinator (if applicable); a description of the covered entity's
process for responding to requests from individuals with disabilities
for changes, exceptions, or adjustments to a rule, policy, practice, or
service of the covered entity; and a process for determining whether
making the modification would fundamentally alter the nature of the
health program or activity, including identifying an alternative
modification that does not result in a fundamental alteration to ensure
the individual with a disability receives the benefits or services in
question.
(g) Combined policies and procedures. A covered entity may combine
the content of the policies and procedures required by paragraphs (b)
through (f) of this section with any policies and procedures pursuant
to Title VI, Section 504, Title IX, and the
[[Page 47915]]
Age Act if Section 1557 and the provisions in this part are clearly
addressed therein.
Sec. 92.9 Training.
(a) A covered entity must train relevant employees of its health
programs and activities on the civil rights policies and procedures
required by Sec. 92.8, as necessary and appropriate for the employees
to carry out their functions within the covered entity consistent with
the requirements of this part.
(b) A covered entity must provide training that meets the
requirements of paragraph (a) of this section, as follows:
(1) To each relevant employee of the health program or activity as
soon as possible, but no later than [DATE ONE YEAR AFTER EFFECTIVE DATE
OF FINAL RULE];
(2) Thereafter, to each new relevant employee of the health program
or activity within a reasonable period of time after the employee joins
the covered entity's workforce; and
(3) To each relevant employee of the health program or activity
whose functions are affected by a material change in the policies or
procedures required by Sec. 92.8 of this part and any other civil
rights policies or procedures the covered entity has implemented within
a reasonable period of time after the material change has been made.
(c) A covered entity must contemporaneously document its employees'
completion of the training required by paragraphs (a) and (b) of this
section in written or electronic form and maintain said documentation
for no less than three (3) calendar years.
Sec. 92.10 Notice of nondiscrimination.
(a) A covered entity must provide a notice of nondiscrimination to
participants, beneficiaries, enrollees, and applicants of its health
programs and activities, and members of the public.
(1) The notice required under this paragraph (a) must include the
following information relating to its health programs and activities:
(i) The covered entity does not discriminate on the basis of race,
color, national origin (including limited English proficiency and
primary language), sex (including pregnancy, sexual orientation, gender
identity, and sex characteristics), age, or disability;
(ii) The covered entity provides reasonable modifications for
individuals with disabilities, and appropriate auxiliary aids and
services, including qualified interpreters for individuals with
disabilities and information in alternate formats, such as braille or
large print, free of charge and in a timely manner, when such
modifications, aids, and services are necessary to ensure accessibility
and an equal opportunity to participate to individuals with
disabilities;
(iii) The covered entity provides language assistance services,
including electronic and written translated documents and oral
interpretation free of charge and in a timely manner, when such
services are necessary to provide meaningful access to a limited
English proficient individual;
(iv) How to obtain from the covered entity the reasonable
modifications, appropriate auxiliary aids and services, and language
assistance services in paragraphs (a)(1)(ii) and (iii) of this section;
(v) The contact information for the covered entity's Section 1557
Coordinator designated pursuant to Sec. 92.7 of this part (if
applicable);
(vi) The availability of the covered entity's grievance procedure
pursuant to Sec. 92.8(c) of this part and how to file a grievance (if
applicable);
(vii) Details on how to file a discrimination complaint with OCR in
the Department; and
(viii) How to access the covered entity's website, if it has one,
that provides the information required under paragraph (a)(1) of this
section.
(2) The notice must be provided in a covered entity's health
program or activity, as follows:
(i) On an annual basis to participants, beneficiaries, enrollees
(including late and special enrollees), and applicants of its health
program or activity;
(ii) Upon request;
(iii) At a conspicuous location on the covered entity's health
program or activity website, if it has one; and
(iv) In clear and prominent physical locations where it is
reasonable to expect individuals seeking service from the health
program or activity to be able to read or hear the notice.
(b) A covered entity may combine the content of the notice required
by paragraph (a) of this section with the notices required by 45 CFR
80.6(d), 84.8, 86.9, and 91.32 if the combined notice clearly informs
individuals of their civil rights under Section 1557 and this part, so
long as it includes each of the elements required by paragraph (a)(1)
of this section.
Sec. 92.11 Notice of availability of language assistance services and
auxiliary aids and services.
(a) A covered entity must provide a notice of availability of
language assistance services and auxiliary aids and services that, at
minimum, states that the covered entity, in its health programs or
activities, provides language assistance services and appropriate
auxiliary aids and services free of charge, when necessary for
compliance with Section 1557 or this part, to participants,
beneficiaries, enrollees, and applicants of its health program or
activities, and members of the public.
(b) This notice of availability of language assistance services and
auxiliary aids and services must be provided in English and at least
the 15 languages most commonly spoken by limited English proficient
individuals of the relevant state or states and must be provided in
alternate formats for individuals with disabilities who require
auxiliary aids and services to ensure effective communication.
(c) The notice required under paragraph (a) of this section must be
provided in a covered entity's health program or activity, as follows:
(1) On an annual basis to participants, beneficiaries, enrollees
(including late and special enrollees), and applicants of its health
program or activity;
(2) Upon request;
(3) At a conspicuous location on the covered entity's health
program or activity website, if it has one;
(4) In clear and prominent physical locations where it is
reasonable to expect individuals seeking service from the health
program or activity to be able to read or hear the notice; and
(5) In the following electronic and written communications when
these forms are provided by a covered entity:
(i) Notice of nondiscrimination required by Sec. 92.10;
(ii) Notice of privacy practices required by 45 CFR 164.520;
(iii) Application and intake forms;
(iv) Notices of denial or termination of eligibility, benefits or
services, including Explanations of Benefits, and notices of appeal and
grievance rights;
(v) Communications related to a person's rights, eligibility,
benefits, or services that require or request a response from a
participant, beneficiary, enrollee, or applicant;
(vi) Communications related to a public health emergency;
(vii) Consent forms and instructions related to medical procedures
or operations, medical power of attorney, or living will (with an
option of providing only one notice for all documents bundled
together);
(viii) Discharge papers;
(ix) Complaint forms; and
(x) Patient and member handbooks.
(d) A covered entity shall be deemed in compliance with this
section with respect to an individual if it exercises the option to:
[[Page 47916]]
(1) On an annual basis, provide the individual with the option to
opt out of receipt of the notice required by this section in their
primary language and through any appropriate auxiliary aids and
services, and:
(i) Does not condition the receipt of any aid or benefit on the
individual's decision to opt out;
(ii) Informs the individual that they have a right to receive the
notice upon request in their primary language and through the
appropriate auxiliary aids and services;
(iii) Informs the individual that opting out of receiving the
notice is not a waiver of their right to receive language assistance
services and any appropriate auxiliary aids and services as required by
this part;
(iv) Documents, on an annual basis, that the individual has opted
out of receiving the notice required by this section for that year; and
(v) Does not treat a non-response from an individual as a decision
to opt out; or
(2) Document the individual's primary language and any appropriate
auxiliary aids and services and:
(i) Provides all materials and communications in that individual's
primary language and through any appropriate auxiliary aids and
services; or
(ii) Provides the notice required by paragraph (a) of this section
in that individual's primary language and through any appropriate
auxiliary aids and services in all communications that are identified
in paragraph (c)(5) of this section.
Subpart B--Nondiscrimination Provisions
Sec. 92.101 Discrimination prohibited.
(a) General. (1) Except as provided in Title I of the ACA, an
individual must not, on the basis of race, color, national origin, sex,
age, or disability, be excluded from participation in, be denied the
benefits of, or otherwise be subjected to discrimination under any
health program or activity operated by a covered entity.
(2) Discrimination on the basis of sex includes, but is not limited
to, discrimination on the basis of sex stereotypes; sex
characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; and gender identity.
(b) Specific prohibitions on discrimination. (1) In any health
program or activity to which this part applies:
(i) A recipient and State Exchange must comply with the specific
prohibitions on discrimination in the Department's implementing
regulations for Title VI, Section 504, Title IX, and the Age Act, found
at parts 80, 84, 86 (subparts C and D), and 91 (subpart B) of this
subchapter, respectively. Where this paragraph cross-references
regulatory provisions that use the term ``recipient,'' the term
``recipient or State Exchange'' shall apply in its place. Where this
paragraph cross-references regulatory provisions that use the term
``student,'' ``employee,'' or ``applicant,'' these terms shall be
replaced with ``individual.''
(ii) The Department, including Federally-facilitated Exchanges,
must comply with specific prohibitions on discrimination in the
Department's implementing regulations for Title VI, Section 504, Title
IX, and the Age Act, found at parts 80, 85, 86 (subparts C and D), and
91 (subpart B) of this subchapter, respectively. Where this paragraph
cross-references regulatory provisions that use the term ``a
recipient,'' the term ``the Department or a Federally-facilitated
Exchange'' shall apply in its place. Where this paragraph cross-
references regulatory provisions that use the term ``student,''
``employee,'' or ``applicant,'' these terms shall be replaced with
``individual.''
(2) The enumeration of specific prohibitions on discrimination in
paragraph (b)(1) of this section does not limit the general
applicability of the prohibition in paragraph (a) of this section.
Subpart C--Specific Applications to Health Programs and Activities
Sec. 92.201 Meaningful access for limited English proficient
individuals.
(a) General requirement. A covered entity must take reasonable
steps to provide meaningful access to each limited English proficient
individual eligible to be served or likely to be directly affected by
its health programs and activities.
(b) Language assistance services requirements. Language assistance
services required under paragraph (a) of this section must be provided
free of charge, be accurate and timely, and protect the privacy and the
independent decision-making ability of the limited English proficient
individual.
(c) Specific requirements for interpreter and translation services.
(1) When interpretation services are required under this part, a
covered entity must offer a qualified interpreter in its health
programs and activities.
(2) When translation services are required under this part, a
covered entity must use a qualified translator in its health programs
and activities.
(3) If a covered entity uses machine translation when the
underlying text is critical to the rights, benefits, or meaningful
access of a limited English proficient individual, when accuracy is
essential, or when the source documents or materials contain complex,
non-literal or technical language, the translation must be reviewed by
a qualified human translator.
(d) Evaluation of compliance. In evaluating whether a covered
entity has met its obligation under paragraph (a) of this section, the
Director shall:
(1) Evaluate, and give substantial weight to, the nature and
importance of the health program or activity and the particular
communication at issue, to the limited English proficient individual;
and
(2) Take into account other relevant factors, including the
effectiveness of the covered entity's written language access
procedures for its health programs and activities, that the covered
entity has implemented pursuant to Sec. 92.8(d).
(e) Restricted use of certain persons to interpret or facilitate
communication. A covered entity must not, in its health programs and
activities:
(1) Require a limited English proficient individual to provide
their own interpreter, or to pay the cost of their own interpreter;
(2) Rely on an adult, not qualified as an interpreter, accompanying
a limited English proficient individual to interpret or facilitate
communication, except:
(i) As a temporary measure, while finding a qualified interpreter
in an emergency involving an imminent threat to the safety or welfare
of an individual or the public where there is no qualified interpreter
for the limited English proficient individual immediately available and
the qualified interpreter that arrives confirms or supplements the
initial communications with the accompanying adult; or
(ii) Where the limited English proficient individual specifically
requests that the accompanying adult interpret or facilitate
communication, the accompanying adult agrees to provide such
assistance, the request and agreement by the accompanying adult is
documented, and reliance on that adult for such assistance is
appropriate under the circumstances.
(3) Rely on a minor child to interpret or facilitate communication,
except as a temporary measure while finding a qualified interpreter in
an emergency involving an imminent threat to the safety or welfare of
an individual or the
[[Page 47917]]
public where there is no qualified interpreter for the limited English
proficient individual immediately available and the qualified
interpreter that arrives confirms or supplements the initial
communications with the minor child; or
(4) Rely on staff other than qualified interpreters, qualified
translators, or qualified bilingual/multilingual staff to communicate
directly with limited English proficient individuals.
(f) Video remote interpreting services. A covered entity that
provides a qualified interpreter for a limited English proficient
individual through video remote interpreting services in the covered
entity's health programs and activities must provide:
(1) Real-time full-motion video and audio over a dedicated high-
speed, wide-bandwidth video connection or wireless connection that
delivers high quality video images that do not produce lags, choppy,
blurry, or grainy images, or irregular pauses in communication;
(2) A sharply delineated image that is large enough to display the
interpreter's face and the participating person's face regardless of
the person's body position;
(3) A clear, audible transmission of voices; and
(4) Adequate training to users of the technology and other involved
persons so that they may quickly and efficiently set up and operate the
video remote interpreting.
(g) Audio remote interpreting services. A covered entity that
provides a qualified interpreter for a limited English proficient
individual through audio remote interpreting services in the covered
entity's health programs and activities must provide:
(1) Real-time audio over a dedicated high-speed, wide-bandwidth
connection or wireless connection that delivers high-quality audio
without lags or irregular pauses in communication;
(2) A clear, audible transmission of voices; and
(3) Adequate training to users of the technology and other involved
persons so that they may quickly and efficiently set up and operate the
remote interpreting services.
(h) Acceptance of language assistance services is not required.
Nothing in this section shall be construed to require a limited English
proficient individual to accept language assistance services.
Sec. 92.202 Effective communication for individuals with
disabilities.
(a) A covered entity must take appropriate steps to ensure that
communications with individuals with disabilities (including companions
with disabilities), are as effective as communications with non-
disabled individuals in its health programs and activities, in
accordance with the standards found at 28 CFR 35.130 and 28 CFR 35.160
through 35.164. Where the regulatory provisions referenced in this
section use the term ``public entity,'' the term ``covered entity''
shall apply in its place.
(b) A covered entity must provide appropriate auxiliary aids and
services to individuals with impaired sensory, manual, or speaking
skills, where necessary to afford such individuals an equal opportunity
to benefit from the service in question.
Sec. 92.203 Accessibility for buildings and facilities.
(a) No qualified individual with a disability shall, because a
covered entity's facilities are inaccessible to or unusable by
individuals with disabilities, be denied the benefits of, be excluded
from participation in, or otherwise be subjected to discrimination
under any health program or activity to which this part applies.
(b) Each facility or part of a facility in which health programs or
activities are conducted that is constructed or altered by or on behalf
of, or for the use of, a recipient or State Exchange must comply with
the 2010 Standards if the construction or alteration was commenced on
or after July 18, 2016, except that if a facility or part of a facility
in which health programs or activities are conducted that is
constructed or altered by or on behalf of, or for the use of, a
recipient or State Exchange, was not covered by the 2010 Standards
prior to July 18, 2016, such facility or part of a facility must comply
with the 2010 Standards if the construction was commenced after January
18, 2018. Departures from particular technical and scoping requirements
by the use of other methods are permitted where substantially
equivalent or greater access to and usability of the facility is
provided. All newly constructed or altered buildings or facilities
subject to this section must comply with the requirements for a
``public building or facility'' as defined in section 106.5 of the 2010
Standards.
(c) Each facility or part of a facility in which health programs or
activities under this part are conducted that is constructed or altered
by or on behalf of, or for the use of, a recipient or State Exchange in
conformance with the 1991 Standards at appendix D to 28 CFR part 36 or
the 2010 Standards shall be deemed to comply with the requirements of
this section and with 45 CFR 84.23(a) and (b) with respect to those
facilities, if the construction or alteration was commenced on or
before July 18, 2016. Each facility or part of a facility in which
health programs or activities are conducted that is constructed or
altered by or on behalf of, or for the use of, a recipient or State
Exchange in conformance with UFAS shall be deemed to comply with the
requirements of this section and with 45 CFR 84.23(a) and (b), if the
construction was commenced on or before July 18, 2016, and such
facility was not covered by the 1991 Standards or 2010 Standards.
Sec. 92.204 Accessibility of information and communication technology
for individuals with disabilities.
(a) A covered entity must ensure that its health programs and
activities provided through information and communication technology
are accessible to individuals with disabilities, unless doing so would
result in undue financial and administrative burdens or a fundamental
alteration in the nature of the health programs or activities. If an
action required to comply with this section would result in such an
alteration or such burdens, a covered entity shall take any other
action that would not result in such an alteration or such burdens but
would nevertheless ensure that, to the maximum extent possible,
individuals with disabilities receive the benefits or services of the
health program or activity provided by the covered entity.
(b) A recipient or State Exchange shall ensure that its health
programs and activities provided through websites and mobile
applications comply with the requirements of Section 504 of the
Rehabilitation Act, as interpreted consistent with Title II of the ADA
(42 U.S.C. 12131 through 12165).
Sec. 92.205 Requirement to make reasonable modifications.
A covered entity must make reasonable modifications to policies,
practices, or procedures in its health programs and activities when
such modifications are necessary to avoid discrimination on the basis
of disability, unless the covered entity can demonstrate that making
the modifications would fundamentally alter the nature of the health
program or activity. For the purposes of this section, the term
``reasonable modifications'' shall be interpreted in a manner
consistent with the term as set forth in the ADA Title II regulation at
28 CFR 35.130(b)(7).
[[Page 47918]]
Sec. 92.206 Equal program access on the basis of sex.
(a) A covered entity must provide individuals equal access to its
health programs and activities without discriminating on the basis of
sex.
(b) In providing access to health programs and activities, a
covered entity must not:
(1) Deny or limit health services, including those that are offered
exclusively to individuals of one sex, to an individual based upon the
individual's sex assigned at birth, gender identity, or gender
otherwise recorded;
(2) Deny or limit a health care professional's ability to provide
health services on the basis of an individual's sex assigned at birth,
gender identity, or gender otherwise recorded if such denial or
limitation has the effect of excluding individuals from participation
in, denying them the benefits of, or otherwise subjecting them to
discrimination on the basis of sex under a covered health program or
activity;
(3) Adopt or apply any policy or practice of treating individuals
differently or separating them on the basis of sex in a manner that
subjects any individual to more than de minimis harm, including by
adopting a policy or engaging in a practice that prevents an individual
from participating in a health program or activity consistent with the
individual's gender identity; or
(4) Deny or limit health services sought for purpose of gender
transition or other gender-affirming care that the covered entity would
provide to an individual for other purposes if the denial or limitation
is based on a patient's sex assigned at birth, gender identity, or
gender otherwise recorded.
(c) Nothing in this section requires the provision of any health
service where the covered entity has a legitimate, nondiscriminatory
reason for denying or limiting that service, including where the
covered entity typically declines to provide the health service to any
individual or where the covered entity reasonably determines that such
health service is not clinically appropriate for a particular
individual. However, a provider's belief that gender transition or
other gender-affirming care can never be beneficial for such
individuals (or its compliance with a state or local law that reflects
a similar judgment) is not a sufficient basis for a judgment that a
health service is not clinically appropriate.
(d) The enumeration of specific forms of discrimination in
paragraph (b) of this section does not limit the general applicability
of the prohibition in paragraph (a) of this section.
Sec. 92.207 Nondiscrimination in health insurance and other health-
related coverage.
(a) A covered entity must not, in providing or administering health
insurance coverage or other health-related coverage, discriminate on
the basis of race, color, national origin, sex, age, or disability.
(b) A covered entity must not, in providing or administering health
insurance coverage or other health-related coverage:
(1) Deny, cancel, limit, or refuse to issue or renew health
insurance coverage or other health-coverage, or deny or limit coverage
of a claim, or impose additional cost sharing or other limitations or
restrictions on coverage, on the basis of race, color, national origin,
sex, age, or disability;
(2) Have or implement marketing practices or benefit designs that
discriminate on the basis of race, color, national origin, sex, age, or
disability in health insurance coverage or other health-related
coverage;
(3) Deny or limit coverage, deny or limit coverage of a claim, or
impose additional cost sharing or other limitations or restrictions on
coverage, to an individual based upon the individual's sex at birth,
gender identity, or gender otherwise recorded;
(4) Have or implement a categorical coverage exclusion or
limitation for all health services related to gender transition or
other gender-affirming care;
(5) Otherwise deny or limit coverage, deny or limit coverage of a
claim, or impose additional cost sharing or other limitations or
restrictions on coverage, for specific health services related to
gender transition or other gender-affirming care if such denial,
limitation, or restriction results in discrimination on the basis of
sex; or
(6) Have or implement benefit designs that do not provide or
administer health insurance coverage or other health-related coverage
in the most integrated setting appropriate to the needs of qualified
individuals with disabilities.
(c) Nothing in this section requires coverage of any health service
where the covered entity has a legitimate, nondiscriminatory reason for
determining that such health service fails to meet applicable coverage
requirements, such as medical necessity requirements, in an individual
case.
(d) The enumeration of specific forms of discrimination in
paragraph (b) of this section does not limit the general applicability
of the prohibition in paragraph (a) of this section.
Sec. 92.208 Prohibition on sex discrimination related to marital,
parental, or family status.
In determining whether an individual satisfies any policy or
criterion regarding access to its health programs or activities, a
covered entity must not take an individual's sex into account in
applying any rule concerning an individual's current, perceived,
potential, or past marital, parental, or family status.
Sec. 92.209 Nondiscrimination on the basis of association.
A covered entity must not exclude from participation in, deny the
benefits of, or otherwise discriminate against an individual in its
health programs and activities on the basis of the respective race,
color, national origin, sex, age, or disability of the individual and
another person with whom the individual has a relationship or
association.
Sec. 92.210 Nondiscrimination in the use of clinical algorithms in
decision-making.
A covered entity must not discriminate on the basis of race, color,
national origin, sex, age, or disability in its health programs and
activities through the use of clinical algorithms in its decision-
making.
Sec. 92.211 Nondiscrimination in the delivery of health programs and
activities through telehealth services.
A covered entity must not, in delivery of its health programs and
activities through telehealth services, discriminate on the basis of
race, color, national origin, sex, age, or disability.
Subpart D--Procedures
Sec. 92.301 Enforcement mechanisms.
The enforcement mechanisms available for and provided under Title
VI of the Civil Rights Act of 1964, Title IX of the Education
Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, and
the Age Discrimination Act of 1975 shall apply for purposes of Section
1557 as implemented by this part.
Sec. 92.302 Notification of views regarding application of Federal
conscience and religious freedom laws.
(a) A recipient may notify OCR of the recipient's view that it is
exempt from certain provisions of this part due to the application of a
Federal conscience or religious freedom law.
(b) Once OCR receives such notification from a particular
recipient, OCR shall promptly consider those views in responding to any
complaints or otherwise determining whether to
[[Page 47919]]
proceed with any investigation or enforcement activity regarding that
recipient's compliance with the relevant provisions of this part. Any
relevant ongoing investigation or enforcement activity regarding the
recipient shall be held in abeyance until a determination has been made
under paragraph (c) of this section.
(c) Based on the information provided in the notification under
paragraph (a) of this section, OCR may determine at any time whether a
recipient is exempt from the application of certain provisions of this
part, or whether modified application of the provision is required as
applied to specific contexts, procedures, or health care services,
based on a Federal conscience or religious freedom law. OCR will assess
whether there is a sufficiently concrete factual basis for making a
determination and will apply the applicable legal standards of the
relevant law. OCR will communicate its determination to the recipient.
(d) If OCR determines that a recipient is exempt from the
application of certain provisions of this part or modified application
of certain provisions is required as applied to specific contexts,
procedures, or health care services, based on a Federal conscience or
religious freedom law, that determination does not otherwise limit the
application of any other provision of this part to the recipient or to
other contexts, procedures, or health care services.
Sec. 92.303 Procedures for health programs and activities conducted
by recipients and State Exchanges.
(a) The procedural provisions applicable to title VI apply with
respect to administrative enforcement actions concerning discrimination
on the basis of race, color, national origin, sex, and disability
discrimination under Section 1557 or this part. These procedures are
found at 45 CFR 80.6 through 80.11 and part 81 of this subchapter.
(b) The procedural provisions applicable to the Age Act apply with
respect to administrative enforcement actions concerning age
discrimination under Section 1557 or this part. These procedures are
found at 45 CFR 91.41 through 91.50.
(c) When a recipient fails to provide OCR with requested
information in a timely, complete, and accurate manner, OCR may, after
attempting to reach voluntary resolution, find noncompliance with
Section 1557 and initiate appropriate enforcement procedures, found at
45 CFR 80.8, including beginning the process for fund suspension or
termination and taking other action authorized by law.
Sec. 92.304 Procedures for health programs and activities
administered by the Department.
(a) This section applies to discrimination on the basis of race,
color, national origin, sex, age, or disability in health programs and
activities administered by the Department, including the Federally-
facilitated Exchanges.
(b) The procedural provisions applicable to Section 504 at 45 CFR
85.61 through 85.62 shall apply with respect to administrative
enforcement actions against the Department concerning discrimination on
the basis of race, color, national origin, sex, age, or disability
under Section 1557 or this part. Where this section cross-references
regulatory provisions that use the term ``handicap,'' the term ``race,
color, national origin, sex, age, or disability'' shall apply in its
place.
(c) The Department must permit access by OCR to its books, records,
accounts, other sources of information, and facilities as may be
pertinent to ascertain compliance with Section 1557 or this part. Where
any information required of the Department is in the exclusive
possession of any other agency, institution or person, and the other
agency, institution or person fails or refuses to furnish this
information, the Department shall so certify and shall set forth what
efforts it has made to obtain the information. Asserted considerations
of privacy or confidentiality may not operate to bar OCR from
evaluating or seeking to enforce compliance with Section 1557 or this
part. Information of a confidential nature obtained in connection with
compliance evaluation or enforcement shall not be disclosed except
where necessary under the law.
(d) The Department must not intimidate, threaten, coerce,
retaliate, or otherwise discriminate against any individual or entity
for the purpose of interfering with any right or privilege secured by
Section 1557 or this part, or because such individual or entity has
made a complaint, testified, assisted, or participated in any manner in
an investigation, proceeding or hearing under Section 1557 or this
part. The identity of complainants must be kept confidential by OCR in
accordance with applicable Federal law.
PART 147--HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND
INDIVIDUAL HEALTH INSURANCE MARKETS
0
16. The authority citation for part 147 continues to read as follows:
Authority: 42 U.S.C. 300gg through 300gg-63, 300gg-91, and
300gg-92, 300gg-111 through 300gg-139, as amended, and section 3203,
Pub. L. 116-136, 134 Stat. 281.
Sec. 147.104 [Amended]
0
17. Amend Sec. 147.104 in paragraph (e) by removing the term ``sex''
and adding in its place the phrase ``sex (including sexual orientation
and gender identity)''.
PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED
STANDARDS UNDER THE AFFORDABLE CARE ACT
0
18.The authority citation for part 155 is amended to read as follows:
Authority: 42 U.S.C. 18021-18024, 18031-18033, 18041-18042,
18051, 18054, 18071, 18081-18083, and 18116.
Sec. 155.120 [Amended]
0
19. Amend Sec. 155.120 in paragraph (c)(1)(ii) by removing the term
``sex'' and adding in its place the phrase ``sex (including sexual
orientation and gender identity)''.
Sec. 155.220 [Amended]
0
20. Amend Sec. 155.220 in paragraph (j)(2)(i) by removing the term
``sex'' and adding in its place the phrase ``sex (including sexual
orientation and gender identity)''.
PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE
CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
0
21. The authority citation for part 156 is amended to read as follows:
Authority: 42 U.S.C. 18021-18024, 18031-18032, 18041-18042,
18044, 18054, 18061, 18063, 18071, 18082, 18116, and 26 U.S.C. 36B.
Sec. 156.200 [Amended]
0
22. Amend Sec. 156.200 in paragraph (e) by removing the term ``sex''
and adding in its place the phrase ``sex (including sexual orientation
and gender identity)''.
[[Page 47920]]
Sec. 156.1230 [Amended]
0
23. Amend Sec. 156.1230 in paragraph (b)(2) by removing the term
``sex'' and adding in its place the phrase ``sex (including sexual
orientation and gender identity)''.
Dated: July 25, 2022.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-16217 Filed 7-28-22; 4:15 pm]
BILLING CODE 4153-01-P