[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Rules and Regulations]
[Pages 37522-37703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08711]
[[Page 37521]]
Vol. 89
Monday,
No. 88
May 6, 2024
Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 438, 440, 457, et al.
45 CFR Parts 80, 84, 92, et al.
Nondiscrimination in Health Programs and Activities; Final Rule
Federal Register / Vol. 89 , No. 88 / Monday, May 6, 2024 / Rules and
Regulations
[[Page 37522]]
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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, 92, 147, 155, and 156
RIN 0945-AA17
Nondiscrimination in Health Programs and Activities
AGENCY: Office for Civil Rights, Office of the Secretary, Department of
Health and Human Services; Centers for Medicare & Medicaid Services,
Department of Health and Human Services.
ACTION: Final rule and interpretation.
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SUMMARY: The Department of Health and Human Services (HHS or the
Department) is issuing this final rule regarding 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 revising its interpretation
regarding whether Medicare Part B constitutes Federal financial
assistance for purposes of civil rights enforcement. Additionally, the
Department is revising provisions prohibiting discrimination on the
basis of sex 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 (EHB); and qualified health plan issuers.
DATES: Effective date: July 5, 2024.
Applicability dates: Unless otherwise specified, the provisions of
this final rule apply on or after July 5, 2024. See the SUPPLEMENTARY
INFORMATION section for additional information.
FOR FURTHER INFORMATION CONTACT:
Office for Civil Rights
Daniel Shieh, Associate Deputy Director, HHS Office for Civil
Rights (202) 240-3110 or (800) 537-7697 (TDD), or via email at
[email protected], for matters related to section 1557.
Centers for Medicare & Medicaid Services
John Giles, (410) 786-5545, for matters related to Medicaid.
Meg Barry, 410-786-1536, 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 or Leigha Basini, (301) 492-4380,
for matters related to 45 CFR 155.120, 155.220, 156.125, 156.200, and
156.1230.
Lisa Cuozzo, (410) 786-1746, 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 appropriate auxiliary aid or service to an individual
with a disability who needs assistance to review the comments or other
documents in the public rulemaking record for the final rule. To
schedule an appointment for this type of accommodation or auxiliary
aid, please call (202) 240-3110 or (800) 537-7697 (TDD) for assistance
or email [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Regulatory History
B. Overview of the Final Rule
II. Provisions of the Proposed Rule and Analysis and Responses to
Public Comments
Subpart A--General Provisions
Purpose and Effective Date (Sec. 92.1)
Application (Sec. 92.2)
Treatment of the Title IX Religious Exception
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)
Data Collection
Subpart B--Nondiscrimination Provisions
Discrimination Prohibited (Sec. 92.101)
Subpart C--Specific Applications to Health Programs and
Activities
Meaningful Access for Individuals With Limited English
Proficiency (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)
Nondiscrimination in the Use of Patient Care Decision Support
Tools (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 Religious
Freedom and Conscience 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)
III. Change in Interpretation--Medicare Part B Funding Meets the
Definition of Federal Financial Assistance; Responses to Public
Comment
IV. 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
1. Comments and Responses to 45 CFR 147.104(e), 155.120(c),
155.220(j), 156.125(b), 156.200(e), and 156.1230(b)
2. Health Insurance Exchanges
a. Non-Interference With Federal Law and Nondiscrimination
Standards (45 CFR 155.120)
b. Federally-Facilitated Exchange Standards of Conduct (45 CFR
155.220)
c. Essential Health Benefits Package: Prohibition on
Discrimination (45 CFR 156.125)
d. QHP Issuer Participation Standards (45 CFR 156.200)
e. Direct Enrollment With the QHP Issuer in a Manner Considered
To Be Through the Exchange (45 CFR 156.1230)
3. Prohibition of Discrimination--Group and Individual Health
Insurance Markets Guaranteed Availability of Coverage (45 CFR
147.104)
V. Executive Order 12866 and Related Executive Orders on Regulatory
Review
A. Regulatory Impact Analysis
a. Baseline Conditions
b. Costs of the Final Rule
[[Page 37523]]
c. Total Quantified Costs
3. Discussion of Benefits
4. Analysis of Regulatory Alternatives to the Final Rule
B. Regulatory Flexibility Act--Final Small Entity Analysis
1. Entities That Will Be Affected
a. Physicians
b. Pharmacies
c. Health Insurance Issuers
d. Local Government Entities
2. Whether the Rule Will Have a Significant Economic Impact on
Covered Small Entities
C. Executive Order 12250 on Leadership and Coordination of
Nondiscrimination Laws
D. Paperwork Reduction Act
1. ICRs Regarding Assurances (Sec. 92.5)
2. ICRs Regarding Section 1557 Coordinator (Sec. 92.7) and
Training (Sec. 92.9)
3. ICRs Regarding Notice of Nondiscrimination (Sec. 92.10) and
Notice of Availability of Language Assistance Services and Auxiliary
Aids and Services (Sec. 92.11)
E. Assessment of Federal Regulation and Policies on Families
I. Background
Section 1557 of the Affordable Care Act (ACA) (section 1557), 42
U.S.C. 18116, 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, except where
otherwise provided in title I of the ACA. 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 (title VI), 42 U.S.C. 2000d et seq., title IX of the Education
Amendments of 1972 (title IX), 20 U.S.C. 1681 et seq., the Age
Discrimination Act of 1975 (Age Act), 42 U.S.C. 6101 et seq., and
section 504 of the Rehabilitation Act of 1973 (section 504), 29 U.S.C.
794, to identify the grounds of discrimination prohibited by section
1557. The entities to which section 1557 and this final rule apply
(i.e., recipients of Federal financial assistance, the Department, and
title I entities) are collectively referred to as ``covered entities.''
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, 42 U.S.C.
18116(a). 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, 42 U.S.C. 18116(c).
A. Regulatory History
On August 1, 2013, the HHS Office for Civil Rights (OCR) published
a Request for Information in the Federal Register, 78 FR 46558,\1\
followed by issuance of a notice of proposed rulemaking (NPRM) on
September 8, 2015 (2015 NPRM), 80 FR 54171.\2\ OCR finalized the first
section 1557 regulation on May 18, 2016 (2016 Rule), 81 FR 31375. On
June 14, 2019, the Department published a new section 1557 NPRM (2019
NPRM), 84 FR 27846, proposing to rescind and replace large portions of
the 2016 Rule.\3\ On June 12, 2020, OCR publicly posted its second
section 1557 final rule (2020 Rule), which was published in the Federal
Register on June 19, 2020, 85 FR 37160. The 2020 Rule remains in
effect, save for the parts enjoined or set aside by courts, until the
effective date of this final rule. In the meantime, entities that are
subject to the 2020 Rule must continue to comply with the parts of the
2020 Rule that remain in effect.
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\1\ Responses are available for public inspection at https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments.
\2\ 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\ The 2019 NPRM received roughly 198,845 comments, which are
available for public inspection at https://www.regulations.gov/document/HHS-OCR-2019-0007-0001. This count includes bundled
submissions, including petitions and form letter campaigns, which
were counted as individual comment submissions.
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On January 5, 2022, the Department proposed to amend CMS
regulations such that Exchanges, issuers, and agents and brokers would
be prohibited from discriminating against consumers based on their
sexual orientation or gender identity in the HHS Notice of Benefit and
Payment Parameters for 2023 NPRM, 87 FR 584 (January 5, 2022). CMS did
not finalize the amendments in the Notice of Benefit and Payment
Parameters for the 2023 final rule, 87 FR 27208 (May 6, 2022); instead,
CMS proposed to make the amendments to its regulations in forthcoming
Departmental rulemaking.
On July 25, 2022, OCR publicly posted the section 1557 NPRM
associated with this rulemaking (2022 NPRM or Proposed Rule), which was
published in the Federal Register on August 4, 2022, 87 FR 47824. OCR
invited comment on the Proposed Rule by all interested parties. The
comment period ended on October 3, 2022. In total we received 85,280
comments on the Proposed Rule.\4\ Comments came from a wide variety of
stakeholders, including but not limited to: civil rights/advocacy
groups, including language access organizations, disability rights
organizations, women's advocacy organizations, and organizations
serving lesbian, gay, bisexual, transgender, queer, or intersex
(LGBTQI+) individuals; health care providers; consumer groups;
religious organizations; academic and research institutions;
reproductive health organizations; health plan organizations; health
insurance issuers; State and local agencies; and tribal entities. Of
the total comments, 79,126 were identified as being submitted by
individuals. Of the 85,280 comments received, 70,337 (80 percent) were
form letter copies associated with 30 distinct form letter campaigns.
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\4\ This count includes bundled submissions, including
petitions. The number of submission entries in the Federal Docket
Management System is 75,254 submissions. Responses are available for
public inspection at https://www.regulations.gov/docket/HHS-OS-2022-0012.
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B. Overview of the Final Rule
Section 1557
This preamble is divided into multiple sections: section II
describes changes to the section 1557 regulation and contains four
subparts: subpart A sets forth the rule's general provisions; subpart B
contains the rule's nondiscrimination provisions; subpart C describes
specific applications of the prohibition on discrimination to health
programs and activities; and subpart D describes the procedures that
apply to enforcement of the rule. Section III provides official notice
of HHS's change in interpretation that Medicare Part B meets the
definition of ``Federal financial assistance.'' Section IV describes
changes to CMS regulations.
OCR has made some changes to the Proposed Rule's provisions, based
on the comments we received. Among the changes are the following:
OCR modified proposed Sec. 92.4 (Definitions) to include new
definitions for telehealth, State, relay interpretation, and patient
care decision support tools.
OCR modified proposed Sec. 92.201 (Meaningful access for
individuals with limited English proficiency) to change ``limited
English proficient individual'' to ``individual with limited English
proficiency'' where applicable in this provision and elsewhere where
the term is used. The text for proposed Sec. 92.201(a) was updated to
include ``companions with limited English proficiency'' for clarity and
parity with the rule's effective communication
[[Page 37524]]
provision. OCR also modified proposed Sec. 92.201(f) and proposed
Sec. 92.201(g) to address concerns that audio and video remote
interpreting may not be appropriate to provide meaningful access in
certain circumstances.
OCR modified proposed Sec. 92.206 (Equal program access on the
basis of sex) to clarify a covered entity's ability to raise legitimate
and nondiscriminatory reasons for the denial of care under this
provision, while stating that the basis for a denial or limitation must
not be based on unlawful animus or bias, or constitute a pretext for
discrimination.
OCR modified the text of proposed Sec. 92.207 (Nondiscrimination
in health insurance coverage and other health-related coverage),
consistent with changes to Sec. 92.206(c) to clarify that covered
entities may raise a legitimate, nondiscriminatory reason for denials
or limitations of health services in benefit design and in individual
cases, while stating that the basis for a denial or limitation must not
be based on unlawful animus or bias, or constitute a pretext for
discrimination.
OCR revised proposed Sec. 92.210 (Nondiscrimination in the use of
clinical algorithms in decision-making) to change ``clinical
algorithms'' and ``clinical algorithms in decision-making'' to
``patient care decision support tools.'' OCR further specified the
scope of the application of this provision and the requirement that
covered entities take reasonable steps to mitigate discrimination once
made aware of the potential for discrimination resulting from use of
these tools.
OCR modified proposed Sec. 92.302 (Notification of views regarding
application of Federal religious freedom and conscience laws) to
clarify the application of religious freedom and conscience laws, and
aspects of the administrative process set forth in the provision,
including that a recipient may request an assurance of an exemption
under such laws, the availability of a temporary exemption, and the
availability of an administrative appeal process.
CMS Amendments
In response to comments, CMS is finalizing the proposed amendments
to the CMS regulations with a revision to scope of sex discrimination
to be consistent with section 1557's regulatory text at Sec.
92.101(a)(2).
II. Provisions of the Proposed Rule and Analysis and Responses to
Public Comments
Subpart A--General Provisions
Purpose and Effective Date (Sec. 92.1)
In the 2022 NPRM, proposed Sec. 92.1(a) explained that the purpose
of 45 CFR part 92 is to implement section 1557, which prohibits
discrimination in certain health programs and activities on the
``ground[s] prohibited'' under title VI, title IX, the Age Act, or
section 504. Section 1557 adopts the grounds of these statutes and
prohibits discrimination based on race, color, national origin, sex,
age, or disability.\5\
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\5\ See Schmitt v. Kaiser Found. Health Plan of Wash., 965 F.3d
945, 953 (9th Cir. 2020) (``Section 1557(a) incorporates only the
prohibited `ground[s]' and `[t]he enforcement mechanisms provided
for and available under' the four civil rights statutes. A
prohibited `ground' for discrimination . . . is simply the protected
classification at issue.'').
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Proposed Sec. 92.1(b) provided 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 and provided a
delayed implementation date (referred to as ``applicability date'' in
this final rule) for provisions of this part that require changes to
health insurance or group health plan benefit design.
The comments and our responses regarding the purpose and effective
date are set forth below.
Comment: Several commenters noted that the regulatory purpose
described in the 2022 NPRM strengthens nondiscrimination protections in
health care, and appropriately aligns with section 1557's statutory
text and Congressional intent.
Response: As commenters noted, the 2022 NPRM's purpose is to
prohibit discrimination in accordance with section 1557's statutory
text. The Proposed Rule mirrors the statutory text and clarifies that
the purpose of this rule is to regulate health programs and activities
conducted and funded by the Department and those of title I entities.
Thus, we maintain the regulatory language for Sec. 92.1(a) as proposed
in the 2022 NPRM.
Comment: One commenter observed that, in addition to title IX's
general prohibition of discrimination on the ground of ``sex,'' section
904 of title IX (20 U.S.C. 1684) also prohibits discrimination on the
ground of blindness or severe vision impairment.
Response: Both HHS's and the Department of Education's title IX
regulations define title IX to exclude section 906. See 45 CFR 86.2(a);
34 CFR 106.2(a). While 20 U.S.C. 1684 prohibits certain forms of
discrimination on the ground of blindness or severe vision impairment,
such conditions are disabilities and section 1557 prohibits
discrimination on the basis of disability as it is the ``ground'' of
discrimination prohibited by the statute's reference to section 504.
Accordingly, we decline to revise the regulatory text at Sec. 92.1(a).
Comment: OCR received many comments about the proposed 60-day
effective date for requirements other than those related to health
insurance or group health plan coverage benefit design. Commenters
identified several tasks covered entities would need to accomplish to
comply with the final rule requirements within the proposed 60 days,
including updating existing policies and procedures; developing and
reviewing new content; developing written communications with members
and distributing written documents, including preparing additional
mailings; and familiarizing themselves with new requirements and OCR-
provided tools and resources.
Most of these commenters expressed concern that covered entities
would not be able to develop and implement the required policies and
procedures (Sec. 92.8) and notices (Sec. 92.10, Sec. 92.11), or
complete the proposed training requirement (Sec. 92.9) within the
allotted 60 days. A variety of commenters argued that the 60-day
effective date for Sec. Sec. 92.7 through 92.11 would be unreasonable
for all covered entities, requesting that OCR consider allowing covered
entities more time to come into compliance with the final rule.
Commenters' recommended compliance timeframes varied widely, from
180 days to three years following publication of the final rule in the
Federal Register. One commenter asked that, for the first 18 to 24
months following publication of the final rule in the Federal Register,
OCR's section 1557 enforcement efforts, including complaint
investigations, primarily focus on providing covered entities technical
assistance with respect to their section 1557 obligations.
Response: OCR appreciates comments regarding the effective date and
commenters' identification of factors influencing feasibility of a
single effective date for all section 1557 requirements. We are
maintaining the overall 60-day effective date related to the general
prohibition on discrimination on the basis of race, color, national
origin, sex, age, and disability. This is consistent with the approach
taken with respect to the effective date of our previous
[[Page 37525]]
rulemakings.\6\ However, in light of the comments received, OCR has
determined that it is reasonable to allow additional time for covered
entities to comply with certain procedural requirements. The additional
time will provide covered entities with the opportunity to properly
designate a Section 1557 Coordinator and designee(s) (as applicable);
develop and tailor to their respective organization's policies and
procedures; train relevant staff; and develop their required notices.
For this reason, we are adopting phased-in applicability dates for
certain provisions, as reflected in the chart at the end of this
section.
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\6\ The 2016 Rule's effective date was 60 days after publication
of the final rule, with the exception of the provisions on health
insurance and benefit design, which went into effect the first day
of the first plan year following the effective date. 81 FR 31375.
The 2020 Rule's effective date was 60 days after publication, with
no exceptions. 85 FR 37160.
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Comment: Some commenters requested that OCR allow for temporary
safe harbors for covered entities' compliance with certain aspects of
the final rule. Specifically, commenters suggested that the final rule
allow for an 18-month good faith safe harbor for covered entities
currently operating in accordance with the 2016 Rule language access
requirements, particularly the notice and tagline requirements at
former 45 CFR 92.8.
Response: OCR declines to grant safe harbors for covered entities
that are or have been operating in accordance with the 2016 Rule's
notice and tagline requirements. Granting such a safe harbor would fail
to recognize the importance of this final rule's requirement. The
Notice of Availability of Language Assistance Services and Auxiliary
Aids and Services (``Notice of Availability'') at Sec. 92.11 requires
notice of auxiliary aids and services in addition to language
assistance services, which we have now revised to reflect a delayed
applicability date of one year from the effective date. This revised
applicability date reasonably allows enough time for covered entities
to come into compliance with the Notice of Availability provision.
Comment: Comments from organizational health insurance issuers
generally supported the Proposed Rule's delayed applicability date for
provisions that require changes to health insurance or group health
plan coverage benefits or benefit design, which proposed a delayed
applicability date of the first day of the first plan year beginning on
or after the year following the effective date of the final rule's
publication in the Federal Register.\7\ One commenter generally
requested that OCR provide flexibility for plans depending on when the
rule is finalized. Another commenter specifically requested that OCR
consider allowing a temporary safe harbor compliance exception for
group health plans and health insurance issuers of group health
insurance coverage so that plan design changes for non-calendar-year
plans may be implemented the first day of the new plan year occurring
on or after January 1, 2024.
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\7\ The term ``group health plan'' is generally used to refer to
a health benefit arrangement that is a distinct legal entity and can
also be used to refer to the underlying health coverage or benefits.
For ease of reference, this document uses the term ``group health
plan'' when referring the plan as a distinct legal entity and uses
the term ``group health plan coverage'' to refer to the underlying
health coverage or benefits provided by the group health plan.
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Response: OCR is cognizant that health insurance issuers and group
health plans develop their health insurance coverage and other health-
related coverage benefit designs in advance of the plan year that the
coverage is offered. Accordingly, we are including a delayed
applicability date to the extent that the final rule's provisions
require changes to health insurance coverage or other health-related
coverage, including group health plan coverage benefit design for
health insurance coverage or other health-related coverage that is
newly subject to certain provisions of Sec. 92.207 (Nondiscrimination
in health insurance coverage and other health-related coverage). In
such circumstances, the final rule's applicability date is the first
day of the first plan year beginning on or after January 1, 2025. This
delayed applicability date applies equally to health insurance issuers
and group health plans that are offering calendar-year and non-
calendar-year plans. For example, a newly covered group health plan
eligible for the delayed applicability date that offers a non-calendar
year plan effective July 1, 2024, would have until the following plan
year, effective July 1, 2025, to comply with the benefit design
requirements, as July 1, 2025, would be the first day of the first plan
year beginning on or after January 1, 2025.
The 2020 Rule remains in effect until the effective date of this
final rule. In the interim, covered entities that are subject to the
2020 Rule must continue to comply with the parts of the 2020 Rule that
remain in effect. Notwithstanding the repeal of the former Sec. 92.207
(2016 Rule), the 2020 Rule prohibits discrimination in health insurance
coverage that receives Federal financial assistance. Consistent with
the 2020 Rule preamble, OCR interprets and enforces section 1557 under
the 2020 Rule to prohibit discrimination in benefit design in health
insurance coverage and other health-related coverage that receive
Federal financial assistance.\8\
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\8\ See 85 FR 37160 (stating the rule prohibits age
discrimination, ``including [in] health plan marketing and benefit
design''); id. at 37177 (stating that HHS ``will enforce vigorously
Section 1557's prohibition on discrimination on the basis of
disability against all covered entities, including when
discrimination is alleged to have taken place in benefit design'');
id. at 37201 (``OCR will examine carefully any allegations of
discrimination by health insurance issuers, including through
benefit design.'').
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As such coverage is currently prohibited from having discriminatory
benefit designs, the obligation to comply with this final rule's Sec.
92.207(b)(1) through (5) does not require a delayed applicability date.
Therefore, we have revised the delayed applicability date for Sec.
92.207(b)(1) through (5) under Sec. 92.1(b) to reflect that the
delayed applicability date is for health insurance coverage and other
health-related coverage that are not already subject to this part as of
the date of publication of this final rule. Because Sec. 92.207(b)(6)
(most integrated setting) describes a category of prohibited benefit
design features that OCR is not explicitly enforcing under the 2020
Rule, OCR will not enforce this provision until the delayed
applicability of the first day of the first plan year beginning on or
after January 1, 2025. The delayed applicability date for all
provisions of Sec. 92.207 is in effect for covered health insurance
coverage and other health-related coverage that are not subject to the
2020 Rule as of the date of publication of this final rule and are
therefore newly subject to this final rule.
Examples of health insurance coverage or other health-related
coverage subject to the 2020 Rule (and thus the benefit design
provisions under Sec. 92.207(b)(1) through (5) as of July 5, 2024)
include but are not limited to Medicare Advantage plans, Medicare Part
D plans, Medicaid managed care plans, and qualified health plans.\9\
For complaints received prior to January 1, 2025 alleging
discrimination related to benefit design, OCR will examine whether the
health insurance coverage or other health-related coverage is subject
to the 2020 Rule. If OCR determines the coverage was subject to
[[Page 37526]]
the 2020 Rule, the covered entity providing the coverage is responsible
for complying with the specific benefit design provisions of Sec.
92.207(b)(1) through (5) on July 5, 2024. In its review of such
complaints, OCR will consider the nature of the challenged benefit
design feature and whether it would have been prohibited under the 2020
Rule. For example, a Medicare Advantage plan that imposes additional
cost-sharing for health services related to a particular disease but
not for other diseases would be investigated as potentially
discriminatory under the 2020 Rule and under this final rule as of its
general 60-day effective date. However, if a Medicare Advantage plan
contains a potentially discriminatory design feature related to
integration, OCR would not investigate such an allegation under this
final rule unless the alleged discrimination took place after the
delayed applicability date of the first day of the first plan year
beginning on or after January 1, 2025.
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\9\ Qualified health plans are covered by the 2020 Rule as a
program or activity administered by an entity established under
title I of the ACA (i.e., an Exchange), pursuant to Sec.
92.3(a)(3). See 85 FR 37174. Qualified health plans are also subject
to the 2020 Rule to the extent they receive Federal financial
assistance. Id.
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Further, OCR clarifies that any covered entity offering health
insurance coverage or other health-related coverage subject to the
delayed applicability date for benefit design is still required to
comply with all other provisions of this final rule, as of the general
effective dates and specific applicability dates set forth under Sec.
92.1(b).
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions in Sec. 92.1(a) as
written and amending Sec. 92.1(b), with modifications.
In Sec. 92.1(b), we have included a table that clearly provides
the applicability date for each provision. It appears below:
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Section 1557 Requirement and Date by which covered entities must
provision comply
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Sec. 92.7 Section 1557 Within 120 days of effective date.
Coordinator.
Sec. 92.8 Policies and Within one year of effective date.
Procedures.
Sec. 92.9 Training......... Following a covered entity's
implementation of the policies and
procedures required by Sec. 92.8, and
no later than one year of effective
date.
Sec. 92.10 Notice of Within 120 days of effective date.
nondiscrimination.
Sec. 92.11 Notice of Within one year of effective date.
availability of language
assistance services and
auxiliary aids and services.
Sec. 92.207(b)(1) through For health insurance coverage or other
(5) Nondiscrimination in health-related coverage that was not
health insurance coverage subject to this part as of the date of
and other health-related publication of this rule, by the first
coverage. day of the first plan year (in the
individual market, policy year)
beginning on or after January 1, 2025.
Sec. 92.207(b)(6) By the first day of the first plan year
Nondiscrimination in health (in the individual market, policy year)
insurance coverage and other beginning on or after January 1, 2025.
health-related coverage.
Sec. 92.210(b), (c) Use of Within 300 days of effective date.
patient care decision
support tools.
------------------------------------------------------------------------
Application (Sec. 92.2)
Proposed Sec. 92.2 addressed the application of this regulation.
OCR proposed in Sec. 92.2(a) to apply the final rule, except as
otherwise provided in the regulation, 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. 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.\10\
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\10\ 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'') and section 1321(c)
of the ACA (codified at 42 U.S.C. 18041(c)) (providing for the
Secretary to establish an Exchange if a State elects not to
establish an Exchange or fails to establish an Exchange under
section 1311 of the ACA).
---------------------------------------------------------------------------
In Sec. 92.2(b), we proposed that this regulation would not apply
to an employer with regard to its employment practices, including the
provision of employee health benefits. We noted that, although the 2016
and 2020 Rules applied to employment in very limited circumstances, OCR
determined that the proposed approach would minimize confusion among
individuals seeking relief under Federal Equal Employment Opportunity
laws and would promote clarity regarding the filing and processing of
employment discrimination complaints. We stated our belief that, as is
the case with employment discrimination complaints generally, concerns
regarding the provision of employee health benefits are best resolved
by our Federal partners.
In Sec. 92.2(c), we proposed that if any provision of this
regulation 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 invited comment on the effects of the proposed scope of
application of the regulation, including the application of this part
to recipients of Federal financial assistance from executive agencies
other than the Department; the application to programs and activities
of the Department and other executive agencies; and the application to
employment.
The comments and our responses regarding Sec. 92.2 are set forth
below.
Comment: Many commenters supported Sec. 92.2(a), which commenters
said would reinstate the scope of the section 1557 implementing
regulation to that of the 2016 Rule and recognizes that section 1557
applies to Federal programs like Medicaid and Medicare, the State and
Federal Marketplaces (referred to as ``Exchanges'' in this final rule)
and the plans sold through them, as well as other commercial health
plans if the issuer receives any form of Federal financial assistance.
Commenters noted that ensuring section 1557 protections apply broadly
to an array of entities and programs will ensure the greatest level of
protection for individuals against discriminatory actions that may
interfere with access to health care and health care coverage.
Many commenters noted that the Proposed Rule was consistent with
congressional intent. These commenters noted that Congress was clear in
extending nondiscrimination protections to a broad array of health
programs and activities, and that section 1557 was intended to build
and expand upon existing civil rights laws, while
[[Page 37527]]
providing broad protection against discrimination in health care. These
commenters further noted that Congress has repeatedly expressed that it
intends civil rights laws to be broadly interpreted in order to
effectuate their remedial purposes. Commenters also noted that the
purpose of the ACA itself is to ensure broad access to and coverage of
health care.
Response: We agree that section 1557 protections apply broadly and
that this final rule is the best reading of the statute regarding the
scope of applicability; as such, the 2022 NPRM properly identified
those entities that are covered under section 1557.
Regarding plans sold through State and Federally-facilitated
Exchanges, as discussed under the definition of ``Federal financial
assistance'' at Sec. 92.4, such plans are covered under this rule as a
health program or activity when in receipt of Federal financial
assistance, such as advance payments of the premium tax credit. This is
consistent with the 2016 Rule. Further, as discussed under the
definition of ``health program or activity'' at Sec. 92.4, a health
insurance issuer's other commercial health plans are covered under this
final rule as part of the issuer's operations where the issuer is
principally engaged in the provision or administration of any health
projects, enterprises, ventures, or undertakings. For more information
on the final rule's application to all operations of a health insurance
issuer that is so principally engaged, please see the discussion below
under the definition of ``health program or activity'' at Sec. 92.4.
Comment: Some commenters requested that OCR clarify the extent to
which a covered entity is required to oversee the section 1557
compliance of its vendors and subcontractors. For example, a health
insurance issuer commented that an issuer should not be responsible for
the discriminatory actions of a provider or facility with which the
issuer has contracted for the provision of medical services. Another
commenter requested clarification on when health insurance agents and
brokers are subject to the rule, particularly when they are working
under the auspices of a covered entity, such as an Exchange or a health
insurance issuer. Other commenters suggested that subcontractors should
be considered recipients by virtue of contracting with a recipient of
Federal financial assistance.
Response: Health programs or activities may comprise more than one
recipient of Federal financial assistance. For example, a primary
recipient (or ``direct'' recipient) is an entity that accepts Federal
financial assistance from a Federal agency. The direct recipient may
then distribute the Federal financial assistance to a subrecipient (or
``indirect'' recipient) to carry out all or part of the health program
or activity. Primary recipients and all subrecipients are covered and
must comply with section 1557.\11\ Under general civil rights
principles, both the primary recipient and subrecipient are responsible
for complying with applicable civil rights laws.\12\ Therefore, if an
entity receives Federal financial assistance--directly as a primary
recipient or indirectly as a subrecipient--it would be a covered entity
and responsible for complying with section 1557 and the part.
---------------------------------------------------------------------------
\11\ For further discussion of this issue, see U.S. Dep't of
Justice, Title VI Legal Manual, sec. V.D.4.
\12\ Often, a recipient receives funds with the purpose and
expectation that it will distribute the funds to one or more sub-
grantees or indirect recipients. For example, in Moreno v. Consol.
Rail Corp., 99 F.3d 782 (6th Cir. 1996) (en banc), the U.S.
Department of Transportation provided funds to the State of Michigan
for use in upgrading railroad crossings. The state, in turn,
provided these funds to Conrail. The Sixth Circuit found that
Conrail was a recipient of Federal financial assistance, noting
``[i]t makes no difference, in our view, that the Federal funds of
which Conrail is the recipient come to it through the State of
Michigan rather than being paid to it by the United States
directly.'' Id. at 787.
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While both direct and indirect recipients must comply with section
1557 independently, a direct recipient may not absolve itself of its
obligations by contracting with another entity to provide services or
assistance for which it received Federal financial assistance or using
an agent to do so.\13\ Covered entities are responsible for the conduct
of their subcontractors and cannot contract away their civil rights
obligations through contractual arrangements with subcontractors. For
example, section 1557 and the statutes referenced therein may cover a
contractor that performs an essential function for the recipient,
making the contractor itself a recipient. In Frazier v. Board of
Trustees, 765 F.2d 1278, amended, 777 F.2d 329 (5th Cir. 1985), a case
involving section 504, the court noted that the defendant hospital
contracted out core medical functions, for which it received Federal
financial assistance. The court ruled that this financial assistance to
the hospital ``would not have been [provided] at all were it not for
[the contractor's] performance as a de facto subdivision of [the
hospital],'' and thus the contractor qualified as a recipient for
purposes of section 504, id. at 1289-90.\14\
---------------------------------------------------------------------------
\13\ U.S. Dep't of Justice Title VI Legal Manual, Sec. V.D.5.
\14\ But see Rose v. Cahee, 727 F. Supp. 2d 728, 739 (E.D. Wis.
2010) (court declined to follow Frazier, limiting coverage of the
funding assistance nondiscrimination cover the contractor of a
recipient requirement to those entities receiving the funds directly
and that ``are in a position to choose whether to do so'').
---------------------------------------------------------------------------
The obligation of health insurance agents and brokers as
subcontractors is a fact-specific analysis depending on the contractual
arrangement with a covered entity. If an Exchange or recipient, such as
a health insurance issuer, contracts with an agent or broker to carry
out responsibilities of the covered entity's health program or activity
and uses Federal financial assistance to pay the agent or broker, then
the agent or broker is a subrecipient and thus independently subject to
all the provisions of section 1557. If a contractor does not receive
Federal financial assistance--either as a primary recipient or
subrecipient--it is not a recipient of Federal financial assistance and
not subject to section 1557. We note that agents and brokers under
contract with an Exchange could also be covered by the final rule as a
health program or activity administered by a title I entity under Sec.
92.2(a)(3). Conversely, if the agent or broker is assisting the public
with purchasing health insurance coverage without any contractual
arrangement on behalf of an Exchange or recipient and is not otherwise
receiving Federal financial assistance, then they would not be
considered subrecipients or subcontractors subject to the rule.
Comment: Some commenters stated that because the Federal Government
now extensively subsidizes both medical care and health insurance
coverage and other health-related coverage, the final rule will apply
to practically all health care entities. They argued that because of
this, it would be nearly impossible for medical professionals to work
free of these regulations and, as a result, physicians and faith-based
health care entities would effectively be barred from refusing to
participate in pregnancy termination procedures.
Response: It has long been established that when an entity receives
Federal funds, conditions may be placed on the receipt of those
funds.\15\ Not all providers receive Federal financial assistance;
however, when they do, they must comply with applicable law. The
[[Page 37528]]
rule, however, does not ban physicians and faith-based or other health
care entities from refusing to participate in pregnancy termination
procedures. On the contrary, the ACA itself provides that ``[n]othing
in this Act shall be construed to have any effect on Federal laws
regarding--(i) conscience protection; (ii) willingness or refusal to
provide abortion; and (iii) discrimination on the basis of the
willingness or refusal to provide, pay for, cover, or refer for
abortion or to provide or participate in training to provide
abortion.'' 42 U.S.C. 18023(c)(2)(A).\16\ In addition, the rule has
been revised at Sec. 92.3(c) to recognize that, ``[i]nsofar as the
application of any requirement under this part would violate applicable
Federal protections for religious freedom and conscience, such
application shall not be required.'' Further, in this final rule, the
process regarding exemptions related to religious freedom and
conscience protections has been clarified. See Sec. 92.302.
---------------------------------------------------------------------------
\15\ The Supreme Court has generally treated these civil rights
statutes as enacted based on Congress's Spending Clause Power, which
generally permits Congress to attach conditions to the receipt of
Federal financial assistance. See Barnes v. Gorman, 536 U.S. 181,
189 n.3 (2002) (referring to the Rehabilitation Act as ``Spending
Clause legislation''); id. at 185-86 (``Title VI invokes Congress's
power under the Spending Clause, U.S. Const., Art. 1. Sec. 8, cl.
1, to place conditions on the grant of federal funds.'').
\16\ The application of this final rule to covered entities with
conscience or religious freedom objections are discussed more fully
below in Sec. Sec. 92.3 (Relationship to other laws) and 92.302
(Notification of views regarding application of Federal religious
freedom and conscience laws).
---------------------------------------------------------------------------
Comment: Some commenters supported the restoration of section
1557's application to all health programs or activities administered by
the Department under Sec. 92.2(a)(2). These commenters noted that the
2020 Rule exempts from section 1557 most of the Department's programs
and activities by limiting the application to only those programs and
activities established under title I of the ACA. These commenters
opined that such an interpretation is contrary to the statutory text,
design, and intent of section 1557 and the ACA generally. Other
commenters noted that consistently applying section 1557 requirements
throughout various programs, including the Department's programs,
creates continuity in the interpretation and implementation of
nondiscrimination standards. However, some commenters stated that OCR
did not provide adequate explanation as to why this change in
application is necessary or appropriate.
Response: For the reasons discussed in the 2022 NPRM, 87 FR 47838,
applying this rule to all health programs and activities administered
by the Department, not just those programs and activities established
under title I of the Act, is the best reading of the statutory text of
section 1557. The statutory language provides that section 1557's
discrimination prohibitions apply to ``any program and activity that is
administered by an executive agency or any entity established under
this title.'' 42 U.S.C. 18116(a). As discussed in the 2022 NPRM, the
operative word, ``or,'' distinguishes programs and activities operated
by an executive agency from those operated by a title I entity. 87 FR
47829. To the extent there is ambiguity in the interpretation,
finalizing the rule as proposed better reflects the statutory language
as well as Congress's intent.\17\ The application of section 1557 to
every health program or activity administered by the Department ensures
that nondiscrimination standards are interpreted and applied as
consistently and as broadly as possible and provides for application of
nondiscrimination standards to the Department consistent with the
entities to which it provides Federal financial assistance.
---------------------------------------------------------------------------
\17\ 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).
---------------------------------------------------------------------------
Comment: Some commenters noted that under the most straightforward
reading of section 1557, the regulatory framework should encompass all
of the Department's programs and activities, not just ``health''
programs and activities, and they suggested that the Department extend
the regulation's protections accordingly.
Response: We appreciate commenters' views on this issue. As we
noted in the 2022 NPRM, OCR considered applying the rule to all
programs and activities of the Department and sought comment on this
issue. 87 FR 47838. Based on comments received and additional
consideration, we are applying the final rule to the Department's
health programs and activities, rather than all the Department's
programs and activities, at this time. The Department may consider
future rulemaking at a later date. For this final rule, however, OCR
has determined that it is appropriate to apply the rule to the
Department's ``health'' programs and activities given that the ACA
itself is principally related to health care and the entirety of this
section 1557 rulemaking seeks to regulate ``health'' programs and
activities.
Comment: Commenters supported the rule's application to programs
and activities administered by title I entities under Sec. 92.2(a)(3),
stating it was consistent with statutory text, Congressional intent,
and the nondiscrimination purpose of section 1557 and the ACA.
Response: Proposed Sec. 92.2(a)(3) applied section 1557 to ``every
program or activity administered by a title I entity.'' In the 2022
NPRM, 87 FR 47838, OCR explained that it was unnecessary to include the
modifier ``health'' to programs or activities of a title I entity
because title I entities already meet the definition of ``health
program or activity'' as set forth under Sec. 92.4. While this remains
true, we have reevaluated the regulatory text of Sec. 92.2(b)(3) and
determined that it should be revised to add the modifier ``health'' to
a title I entity's ``program or activity'' for consistency with our
interpretation that section 1557 applies to the Department's ``health''
programs or activities, as discussed in the previous comment. This
technical revision does not limit or alter the scope of Sec.
92.2(b)(3)'s application to the programs or activities of a title I
entity, as we articulated in the 2022 NPRM. 87 FR 47838.
Comment: A few commenters opined that the rule should apply broadly
to recipients of Federal financial assistance from any executive
agency, not just the Department. These commenters noted that nothing in
the statute suggests that Congress intended to limit the scope of
section 1557's application in such a way.
Response: It is OCR's longstanding position that section 1557's
discrimination prohibition is not limited to recipients of Federal
financial assistance from the Department, but rather covers recipients'
health programs or activities regardless of the executive agency
providing the funding.\18\ However, the final rule only applies to
recipients of HHS funding, which is consistent with OCR's delegation of
authority to ``develop and direct implementation of the requirements of
Section 1557 . . . as applied to the Department and recipients of the
Department's funds.'' 85 FR 37242 (emphasis added). Other Federal
agencies possess section 1557 enforcement responsibility for the health
programs and activities they fund and administer.
---------------------------------------------------------------------------
\18\ See U.S. Health & Hum. Servs., Off. for Civil Rts., Memo.
from Jocelyn Samuels, Director, to Directors of Federal Offices for
Civil Rights (Nov. 5, 2015), https://www.hhs.gov/sites/default/files/2015_11_04_fed_civil_rights_section_1557_memo_508.pdf.
---------------------------------------------------------------------------
Comment: Some commenters recommended that the Department provide a
model for other agencies to craft their own, more inclusive, and
[[Page 37529]]
more protective rules for non-health-related programs in line with
other applicable non-discrimination statutes.
Response: OCR appreciates this recommendation and reiterates its
desire to work with other agencies as necessary and appropriate. OCR
only has authority to apply section 1557 to HHS and recipients of
Departmental Federal financial assistance. This rule does not apply to
programs and activities of other agencies and OCR is unable to regulate
other agencies.
Comment: A number of commenters disagreed with the non-application
of the rule to employment practices under Sec. 92.2(b). Commenters
opined that the categorical exclusion of employers is inconsistent with
section 1557's statutory text and creates confusion. Some commenters
noted that an agency to whom a complaint is referred may not adequately
address claims of discrimination, including those of dependents.
Commenters further noted that other employment discrimination laws,
such as title VII of the Civil Rights Act of 1964 (title VII), 42
U.S.C. 2000e et seq., and the Age Discrimination in Employment Act of
1967 (ADEA), 29 U.S.C. 621-634, require a claimant to file a complaint
with a Federal agency before privately enforcing their rights. Some
commenters requested that OCR clarify that this provision concerns only
the processing of administrative complaints by OCR and that OCR's
decision not to apply this rule to employment practices does not
preclude employees from vindicating their section 1557 rights in court.
Other commenters supported proposed Sec. 92.2(b) and noted it will
help prevent wasteful duplication with other Federal laws and agencies
that already cover unlawful employment discrimination.
Response: The Supreme Court has recognized that section 1557
authorizes a private right of action.\19\ This final rule applies only
to OCR's administrative enforcement of section 1557. As discussed in
the 2022 NPRM, 87 FR 47838, we believe that other Federal agencies are
better equipped to review and adjudicate employee health benefits and
allegations of employment discrimination given their expertise under
the existing employment nondiscrimination statutes they enforce.
---------------------------------------------------------------------------
\19\ Cummings v. Premier Rehab Keller, P.L.L.C., 596 U.S. 212
(2022) (section 1557 provides a private right of action because the
incorporated statutes do so).
---------------------------------------------------------------------------
Comment: Some commenters noted that employers are usually the
sponsors of group health plans and raised concerns that OCR could
therefor find an employer liable under section 1557 for the employee
benefits it provides.
Response: This rule does not apply to employers or other plan
sponsors with regard to their employment practices, including the
provision of employee health benefits. As stated in the preamble to the
Proposed Rule, 87 FR 47838, previous rules had limited application to
employment. The 2016 Rule provided that employment practices included
hiring, firing, promotions, or terms and conditions of employment, and
therefore the 2016 Rule did not apply to those practices. However, the
2016 Rule applied to an employer with regard to its employee health
benefit programs under certain circumstances as set forth under former
Sec. 92.208. The 2020 Rule, which repealed the 2016 Rule's reference
to employment practices and employee health benefit programs, reverted
to enforcing the statutorily referenced nondiscrimination statutes
through their existing regulations. As discussed above, the Proposed
Rule proposed to exclude employment practices, which included the
provision of employee health benefit programs. OCR also recognizes that
other sponsors of group health plans undertake similar employment
practices, such as the provision of employee health benefits. For
example, a joint board of trustees for a multi-employer group health
plan (also known as a Taft-Hartley plan) consists of representatives
from employers and unions to sponsor a group health plan, and similarly
engages in the provision of an employee health benefit like employers
that sponsor a single-employer plan. To ensure consistent application
of the rule to entities engaging in similar employment functions, the
final rule revises Sec. 92.2(b) to provide that the rule does not
apply to any employer or other plan sponsor of a group health plan,
including but not limited to, a board of trustees (or similar body),
association or other group, with regard to employment practices,
including the provision of employee health benefits.
Group health plans, employers, and sponsors of group health plans
are generally separate entities from one another that require a
separate, fact-specific analysis to determine whether each entity is
subject to this rule. We discuss the relationship between plan
sponsors, such as employers, joint boards of trustees or similar
bodies, associations, and other groups that are plan sponsors of multi-
employer Taft-Hartley plans or multiple-employer welfare arrangements
(MEWAs), and group health plans in more detail in the discussion of
group health plans in the ``health program or activity'' definition
discussion under Sec. 92.4.
Comment: Some commenters stated that ongoing litigation surrounding
section 1557 and previous iterations of OCR's section 1557 regulations,
as well as agency course reversal on multiple occasions, has created
confusion and compliance burden on covered entities. They urged the
Department to reinforce the importance of severability under Sec.
92.2(c) amongst the various regulatory provisions of the rule.
Response: We appreciate concerns around ongoing litigation and
agency reversal, and the resulting inconsistency in requirements. OCR
has attempted to answer questions and reduce confusion raised by the
previous versions of the rule. While this final rule is similar to the
2016 Rule, it provides greater clarity regarding section 1557's
statutory protections from discrimination along with various provisions
to help alleviate burdens while providing certainty about covered
entities' obligations when compared to the 2016 and 2020 Rules. We
believe the final rule enhances the benefits to individuals and
minimizes the burdens on covered entities.
OCR notes that Sec. 92.2(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. For example, if a court were to invalidate the final
rule's Notice of availability of language assistance services provision
(Notice of Availability) at Sec. 92.11, all other provisions of the
rule would remain in effect, as those provisions ``could function
sensibly without the stricken provision.'' \20\ Thus, if the rule's
Notice of Availability provision were invalidated, OCR would not
enforce that provision. Or, for example, if a court were to invalidate
the final rule's Section 1557 Coordinator requirement at Sec. 92.7,
OCR would not require covered entities to fill this position as part of
their compliance with this final rule, while otherwise enforcing other
administrative requirements such as the Policies and procedures
requirement at Sec. 92.8 and the Notice of nondiscrimination
requirement at Sec. 92.10.
---------------------------------------------------------------------------
\20\ MD/DC/DE Broadcasters Ass'n v. F.C.C., 253 F.3d 732, 734
(D.C. Cir. 2001) (internal quotations omitted).
---------------------------------------------------------------------------
Comment: Some commenters requested that the final rule restore the
2016 Rule clarification that any age
[[Page 37530]]
distinctions exempt from the Age Act are also exempt from section 1557
enforcement.
Response: OCR appreciates commenters' request for clarity and
directs commenters to Sec. 92.101(b)(1) of this regulation, which
adopts by reference the permissible uses of age located in the
Department's Age Act regulations at 45 CFR part 91 (subpart B).
Comment: Some commenters argued that the Proposed Rule is
inappropriate for the Indian Health Services (IHS) facilities because
these are not open to members of the public but reserved for patients
who are eligible beneficiaries as citizens of Tribal Nations, and as
such, tribally operated IHS health facilities \21\ should be exempt.
These commenters stated that the 2022 NPRM failed to recognize the
unique nature of the Indian Health Care System, which is the health
care system for members of federally recognized Tribes in the United
States. Commenters recommended that OCR acknowledge American Indian/
Alaska Native (AI/AN) as a political classification, and not as a race-
based classification. Commenters further opined that the 2022 NPRM
failed to recognize the diplomatic, nation-to-nation relationship
between Tribal Nations and the United States.
---------------------------------------------------------------------------
\21\ Titles I and V of the Indian Self-Determination and
Education Assistance Act, Pub. L. 93-638, as amended, provide Tribes
the option of exercising their right to self-determination by
assuming control and management of programs previously administered
by the Federal Government. Since 1992, the IHS has entered into
agreements with tribes and tribal organizations to plan, conduct,
and administer programs authorized under section 102 of the Act.
Today, over sixty percent of the IHS appropriation is administered
by tribes, primarily through self-determination contracts or self-
governance compacts. U.S. Dep't of Health & Hum. Servs., Indian
Health Servs., IHS Profile, https://www.ihs.gov/newsroom/factsheets/ihsprofile/.
---------------------------------------------------------------------------
Response: OCR appreciates these comments. Similar concerns were
raised during the 2022 NPRM Tribal Consultation held on August 31,
2022, pursuant to Executive Order 13175. The IHS, an agency within the
Department, is responsible for providing health services to members of
federally recognized tribes in 37 states, arising out of the special
government-to-government relationship between the Federal Government
and Indian tribes.\22\
---------------------------------------------------------------------------
\22\ U.S. Dep't of Health & Hum. Servs., Indian Health Servs.,
About IHS, https://www.ihs.gov/aboutihs/.
---------------------------------------------------------------------------
Membership or eligibility in a federally recognized tribal entity
is a political classification rather than a racial classification.\23\
Preferences based upon the unique relationship between the United
States and federally recognized tribal entities are distinct from the
forms of discrimination prohibited by Federal civil rights laws, which
aim to protect all individuals on the basis of race, color, or national
origin (including AI/AN individuals, regardless of political
affiliation).\24\ The Department's regulations implementing title VI
provide that an individual shall not be deemed subjected to
discrimination by reason of their exclusion from benefits limited by
Federal law to individuals of a different race, color, or national
origin. 45 CFR 80.3(d) (Indian Health and Cuban Refugee Services). IHS
is mentioned in the Department's title VI regulation as an example of
such a program. Id. In Sec. 92.101(b), the final rule adopts this
provision by reference, and OCR will fully apply it, as well as other
applicable exemptions or defenses that may exist under Federal law.
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\23\ See Morton v. Mancari, 417 U.S. 535, 553 & n.24 (1974).
\24\ See Morton v. Mancari, 417 U.S. 535, 550 (1974) (``[a]
provision aimed at furthering Indian self-government by according an
employment preference withing the [Bureau of Indian Affairs] for
qualified members of the governed group can readily co-exist with a
general rule prohibiting employment discrimination on the basis of
race.'').
---------------------------------------------------------------------------
Programs of the IHS are administered by IHS and tribes, including
through self-determination contracts or self-governance compacts, and
we intend to address any restrictions on application of the law to IHS
programs in the context of individual complaints.
Comment: Some commenters requested that OCR develop an online tool
that would help covered entities determine whether the final rule
applies either directly or indirectly to an organization or other
health program or activity.
Response: OCR provides various tools on our website to help covered
entities determine their covered entity status and will continue to
ascertain what tools would help the industry ensure widespread
compliance. OCR notes that the Department's Office of Grants operates a
website that tracks obligated Department grant funds, https://taggs.hhs.gov/, which allows the public to identify recipients of
Department funding.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.2, with modification. We are revising Sec. 92.2(a)(3) to add
the modifier ``health'' to ``program or activity administered by a
title I entity.'' We are also revising Sec. 92.2(b) to state that the
provisions of this part shall not apply to any employer ``or other a
plan sponsor of a group health plan, including but not limited to, a
board of trustees (or similar body), association or other group,'' with
regard to its employment practices, including the provision of employee
health benefits.
Treatment of the Title IX Religious Exception
In the 2022 NPRM, OCR proposed to not import the title IX religious
exception into the section 1557 regulation. The title IX statute states
that the nondiscrimination requirements ``shall not apply to an
educational institution which is controlled by a religious
organization'' to the extent that such application ``would not be
consistent with the religious tenets of such organization.'' 20 U.S.C.
1681(a)(3), as amended Public Law 100-259, section 3(b), Mar. 22, 1988,
102 Stat. 29. The title IX statutory definition of ``program or
activity'' further limits the nondiscrimination requirements, in that
they do not apply 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.'' Id. at 1687(4).
In the 2022 NPRM, we said that under the most natural understanding
of section 1557's text, which bans discrimination ``on the ground
prohibited under . . . title IX,'' the statutory term ``ground
prohibited'' is best understood as incorporating only the bases on
which discrimination is prohibited in the referenced statutes (i.e.,
``sex'' in title IX). 87 FR 47839. Rather than import the title IX
exception for ``educational institution[s]'' that are controlled by
``religious organization[s],'' OCR proposed that the best way to
address religious objections to the application of this rule--and the
way most consistent with section 1557's statutory text and structure--
would be through the process provided in proposed Sec. 92.302. We
sought comment on this approach. We particularly invited 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.
The comments and our responses regarding this request for comment
are set forth below.
Comment: Commenters provided mixed responses to OCR's proposal not
to import the title IX religious exception into this rule. Many
commenters supported OCR's statutory interpretation that section 1557
[[Page 37531]]
incorporated the title IX statute only with respect to the ground of
discrimination prohibited (sex) and its enforcement mechanisms (e.g.,
termination of Federal financial assistance and other means authorized
by law). Several commenters stated that this reading is most consistent
with the statutory structure, because if Congress intended for the
title IX religious exception to apply, the statute would also require
the importation of the other title IX exceptions, many of which are by
their terms plainly inapplicable in the context of health care.
Several commenters also stated that if Congress wanted to include
the title IX religious exception, it could have either explicitly
referenced or listed the exception in the section 1557 statutory text.
Many commenters stated that any silence regarding the title IX
exceptions was not an oversight by Congress, but an intentional
decision. Many commenters contended that importing the title IX
religious exception is contrary to the purpose of section 1557 and the
goal of the ACA: to expand access to health care coverage.
Additionally, many commenters said that importing the title IX
religious exception is unnecessary given the numerous other Federal
laws that allow religious organizations and providers to invoke a
conscience or religious objection to providing certain kinds of medical
services and care.
Many other commenters disagreed with OCR's interpretation, claiming
that Congress intended to incorporate the entire title IX statutory
scheme by including the signal ``et seq.'' Several commenters also
argued that title IX's prohibition on sex discrimination cannot be read
separate and apart from all the exceptions included in the title IX
statute, in which Congress authorized certain conduct--i.e., otherwise
prohibited sex discrimination. Accordingly, several commenters
maintained that it is arbitrary and capricious for OCR to rely upon
title IX's implementing regulations as a guide to prohibit
discrimination on the basis of sex, such as those related to pregnancy-
related conditions, or when distinguishing a marital, parental, and
family status, while not importing the statute's religious exception.
A few commenters maintained that the differences between
educational and health care institutions provide an unconvincing
argument for nonimportation of the title IX religious exception because
under the Title IX Common Rule of 2000 (Common Rule),\25\ title IX
already applies to recipients of Federal financial assistance that
provide health care. Many commenters also asserted that the court in
Franciscan Alliance v. Burwell, 227 F. Supp. 3d 660 (N.D. Tex. 2016),
found that the decision not to import the title IX religious exception
into the 2016 Rule, without explanation, was contrary to law. Several
commenters also pointed to that court's determination that the
Department had previously ``provide[d] that when cross-referencing the
provisions of Title IX's use of `student,' the term `individual' should
be used in the healthcare context.'' Id. at 691. Commenters asserted
that this finding by the court undermines the Department's claim that
the title IX religious exception is specific to education and cannot be
adopted more broadly in the health care context.
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\25\ Nondiscrimination on the Basis of Sex in Education Programs
or Activities Receiving Federal Financial Assistance, 65 FR 52857
(Aug. 30, 2000) (multiagency rulemaking adopting consistent title IX
implementing regulations).
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Response: Title IX applies to ``any education program or activity''
operated by recipients of Federal financial assistance, and the statute
creates an exception from coverage for the education programs and
activities of ``an educational institution which is controlled by a
religious organization if the application of [title IX's prohibition on
sex discrimination in education programs and activities] would not be
consistent with the religious tenets of such organization.'' 20 U.S.C.
1681(a)(3). In addition, the Civil Rights Restoration Act of 1987
(CRRA) \26\ statutorily defined ``program or activity'' for title IX to
exclude from coverage ``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.'' 20 U.S.C. 1687(4). The preamble to the
2020 Rule stated that section 1557 ``incorporates the statutory scope
of Title IX, so it is appropriate for this rule to incorporate the
Title IX statutory language concerning religious institutions.'' 85 FR
37208.
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\26\ Public Law 100-259, 102 Stat. 28 (Mar. 22, 1988).
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OCR notes that as an initial matter, the CRRA's exclusion of any
operation of religiously controlled entities from the application of
title IX to the extent such operation is inconsistent with the
religious tenets of the organization is not incorporated into section
1557. As we explain further in the discussion of ``health program or
activity,'' section 1557 includes its own coverage provision that does
not incorporate the CRRA's definitions of ``program or activity.''
Moreover, unlike title VI, section 504, and the Age Act,\27\ title IX
modifies ``program or activity'' with ``education,'' 20 U.S.C. 1681(a),
which limited title IX's prohibition on sex discrimination to the
``education'' context; the definitions of ``program or activity'' under
title VI, section 504, or the Age Act do not include any comparable
exclusion for the operations of religiously controlled entities.\28\
Thus, the CRRA's limitation to the application of certain operations of
religious entities from title IX's coverage applies only in the
``education'' context and is not part of the definition of ``program or
activity'' as that term is used in civil rights statutes more
generally. Further, it is inapplicable to the definition of ``health
program or activity'' adopted in section 1557. As a result, the sole
question is whether the exclusion in title IX, 20 U.S.C. 1681(a)(3), of
certain applications of the statute to ``educational institution[s]
which [are] controlled by a religious organization'' carries over into
section 1557.
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\27\ See 42 U.S.C. 2000d (title VI, prohibiting ``discrimination
under any program or activity receiving Federal financial
assistance''); 42 U.S.C. 6101 (the Age Act, prohibiting
discrimination ``in programs or activities receiving Federal
financial assistance''); 29 U.S.C. 794(a) (section 504 prohibiting
``discrimination under any program or activity receiving Federal
financial assistance or under any program or activity conducted by
any Executive agency or by the United States Postal Service'').
\28\ S. Rep. No. 100-64, 100th Cong., 1st Sess. (1987), as
reprinted in 1988 U.S.C.C.A.N. 3, 6, 1987 WL 61447, at *18
(discussing ``education limitation in Title IX''); see also id. at
*20-*21 (``[The CRRA] leaves the religious tenet exemption in Title
IX intact and clarifies that the exemption is as broad as the Title
IX coverage of education programs and activities.'' (Emphasis
added)).
---------------------------------------------------------------------------
Although title IX's prohibition of sex discrimination applies to
some health-related activities of covered education programs--such as
programs training future health workers--the range of exceptions
provided in section 1681(a) are plainly tied to the educational setting
(e.g., the membership practices of social fraternities and sororities,
YMCA, Girls Scouts, Boys Scouts; voluntary youth service organizations;
father-son and mother-daughter activities; and beauty pageant-based
scholarships, as well as educational admissions practices). All of
these exceptions have little if any application to health programs and
activities. Further, exceptions listed in that subsection include
limitations regarding ``educational institution[s],'' ``institution[s]
of public higher education,'' or ``institution[s] of higher
education.'' 20 U.S.C. 1681(a)(1)-(9).
[[Page 37532]]
The language and subject matter of the exceptions suggest that
Congress, in enacting title IX, did not intend those exceptions to
define the statute's basis of discrimination--what section 1557 calls
the ``ground prohibited''--under title IX. Title IX prohibits
discrimination on the basis of sex, so the ``ground prohibited'' under
that statute is sex. Congress intended these exceptions to delineate
certain contexts in which otherwise prohibited sex discrimination in
the educational context would be excluded from the statute's coverage.
Congress could have chosen to draft section 1557 to incorporate
additional elements from title IX and the other referenced civil rights
statutes (e.g., those statutes' applicability provisions), but did not
do so, instead narrowly specifying that only the ``ground[s]
prohibited'' are incorporated.
OCR further notes that the inclusion of ``et seq.'' is simply part
of an ordinary citation to the title IX statute. Congress frequently
appends ``et seq.'' to statutory citations as a matter of course when
legislation includes a generalized reference to a previously enacted
statute.\29\ Including ``et seq.'' does not change the substantive
meaning of section 1557, which incorporates only the grounds of
prohibited discrimination and the enforcement mechanisms of each
referenced statute. Further, section 1557 includes similar
parenthetical citations with ``et seq.'' for the other referenced civil
rights statutes in both 42 U.S.C. 18116(a) and (b). This underscores
that Congress merely intended to provide the general, ordinary citation
to the statutes being referenced, including title IX.
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\29\ See, e.g., 20 U.S.C. 1689(a)(1) (requesting a task force
``provide pertinent information . . . with respect to campus sexual
violence prevention, investigations, and responses, including the
creation of consistent, public complaint processes for violations of
title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et
seq.)[.]''); accord id. 1689(a)(8), (b)(1), (c).
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Section 1557's role as a health care statute further reinforces our
reading of the statutory text and Congressional intent. Section 1557
was enacted as part of the ACA, in part, to expand access to health
insurance and increase consumer protections. Title IX, as we have
explained, relates specifically to education programs and activities.
The title IX religious exception in that statute allows some entities
to engage in certain conduct without requiring any consideration or
mitigation of harm to third parties. If a similar standard were
imported into this rule, it could undermine a key purpose of section
1557--ensuring access to health care. And as discussed below, unlike
educational settings such as colleges and universities where there is
more choice, individuals often have far fewer choices when accessing
health care. In the federally funded health care context, the array of
statutory conscience provisions enacted by Congress, as well as the
general requirements of the First Amendment and the Religious Freedom
Restoration Act (RFRA), provide a better fitting approach to addressing
the relevant interests. This final rule has been revised to include
regulatory text at Sec. 92.3(c) recognizing that, insofar as the
application of any rule requirement would violate applicable Federal
protections for religious freedom and conscience, such application
shall not be required. Also, we have strengthened the process for
raising religious freedom and conscience protections under this final
rule at Sec. 92.302.
The fact that title IX and agency implementing regulations apply to
some health programs and activities--those that are part of educational
programs and activities \30\--does not suggest that the exceptions set
forth in the statute or implementing regulations apply to health
programs and activities that are not a part of an educational program.
Title IX's limitation to a recipient's education programs and
activities has long been established.\31\ For example, the Common Rule
(adopted by more than 20 Federal agencies) included the statute's
limitation that the prohibition on sex discrimination applied only to
the educational components of a covered entity's program.\32\ As we
have explained, it is inconsistent with the text and purpose of section
1557, as well as the text and structure of title IX, to apply the title
IX exceptions outside of the educational setting. Although the title IX
regulations are relevant to informing what constitutes sex
discrimination for purposes of this final rule--and we have looked to
them for that purpose--that is because section 1557 incorporates the
``ground prohibited'' under title IX. But section 1557 does not
incorporate any of the title IX exceptions. 87 FR 47839.
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\30\ See, e.g., Doe v. Mercy Cath. Med. Ctr., 850 F.3d 545, 555
(3d Cir. 2017) (holding that a hospital's residency program was an
educational program or activity under title IX).
\31\ See O'Connor v. Davis, 126 F.3d 112, 117 (2d Cir. 1997),
cert. denied, 522 U.S. 1114 (1998) (under title IX a program or
activity must be ``such that one could reasonably consider its
mission to be, at least in part, educational''); see also Jeldness
v. Pearce, 30 F.3d 1220, 1224-25 (9th Cir. 1994); Klinger v. Dep't
of Corrs., 107 F.3d 609, 613-16 & n.5 (8th Cir. 1997); Roubideaux v.
North Dakota Dep't of Corrs. & Rehab., 570 F.3d 966, 976-79 (8th
Cir. 2009).
\32\ Nondiscrimination on the Basis of Sex in Education Programs
or Activities Receiving Federal Financial Assistance, 65 FR 52858,
52868 (Aug. 30, 2000).
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OCR disagrees with the Franciscan Alliance decision vacating
portions of the 2016 Rule, and in any event, that decision does not
prohibit OCR from not importing the title IX religious exception in
this final rule. The promulgation of this final rule constitutes new
rulemaking, and OCR has provided a detailed explanation for the
decision to not import the title IX religious exception and has taken
important steps to address religious freedom and conscience protections
beyond those in the 2016 Rule. These steps include revisions at Sec.
92.3(c) to recognizes that, ``[i]nsofar as the application of any
requirement under this part would violate applicable Federal
protections for religious freedom and conscience, such application
shall not be required,'' adoption of a voluntary assurance of exemption
process based on these protections at Sec. 92.302, and the
Department's issuance of a final rule entitled Safeguarding the Rights
of Conscience as Protected by Federal Statutes, 89 FR 2078 (Jan. 11,
2024).
OCR notes that this final rule does not alter or eliminate a
recipient's ability to maintain, seek, claim, or assert a title IX
religious exception under title IX if it meets the applicable
criteria.\33\ And to the extent the recipient is entitled to a
religious exception under title IX, OCR's analysis will consider the
entire statute, including title IX's specific limitation to the context
of educational programs and activities.
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\33\ 20 U.S.C. 1681(a)(3); 45 CFR 86.12.
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Comment: Many commenters supported OCR's proposal not to import the
title IX religious exception, highlighting what they characterized as
the dangers of doing so in the context of health care and the potential
consequences on people's access to health care it might have. For
example, many commenters expressed concerns that providers would be
able to deny essential health care services based on disapproval of a
particular group, thereby putting at risk the health and well-being of
already vulnerable individuals. Many commenters asserted that entities
have invoked religious beliefs to deny individuals access to health
care and coverage for a broad range of health care services. Commenters
said that in urgent or emergency care situations, individuals may be
unable to identify or use the services of an alternate provider when an
institution withholds care based on religious tenets, even when the
[[Page 37533]]
individual is aware of such objections by an institution.
Many commenters highlighted the difference between education and
health care. Multiple commenters stated that unlike certain health care
settings, many parents have the choice to send their children to
religious schools, whereas individuals often lack meaningful choices
when seeking a health care provider, particularly for time-sensitive
care. For example, numerous commenters stated that choice is especially
limited in rural areas, and some patients may only have local access to
religiously affiliated providers. Commenters worried that importing the
title IX religious exception into this rule could have dire
implications for health outcomes.
Response: As previously noted, this rule's application to the
health care context is central to OCR's interpretation of section 1557.
OCR appreciates that religiously affiliated hospitals and health care
facilities play an important role in the health care system and
recognizes the critical patient care needs they provide, including in
underserved communities and areas which otherwise lack access to
quality health care. At the same time, OCR believes that Congress chose
not to import the title IX religious exception into section 1557 due to
concerns about the impact such an action could have on access to health
care. The importation of the title IX religious exception would raise
unique concerns in the health care context that are not typically
present in education programs and activities. As OCR discussed in the
2022 NPRM, health care settings differ from educational settings with
respect to both the ability of affected parties to choose (or avoid)
certain religiously affiliated health care institutions and the urgency
of the need for services provided by the covered entities. 87 FR 47840.
While students and families normally make a deliberate choice to attend
a religious educational institution, in many cases specifically due to
its religious character, individuals seeking health care are far more
likely to be driven by other considerations such as availability,
urgency, geography, insurance coverage, and other factors unrelated to
whether the provider is controlled by or affiliated with a religious
organization. See id. Rather than importing the title IX religious
exception into section 1557, where Congress referenced only the
``ground prohibited under'' and the ``enforcement mechanisms provided''
for in title IX, the process set forth in Sec. 92.302 respects
religious freedom and conscience protections. As this final rule makes
clear at Sec. 92.3(c), insofar as the application of any requirement
under this rule would violate applicable Federal protections for
religious freedom and conscience, such application shall not be
required. Under Sec. 92.302, recipients may rely on these protections
or seek assurance of these protections from OCR, if they wish. In this
process, OCR will comply with the applicable legal standards of the
governing statutes, which include the protections in the ACA itself, 42
U.S.C. 18023; the Church, 42 U.S.C. 300a-7, Coats-Snowe, 42 U.S.C.
238n, and Weldon Amendments, e.g., Consolidated Appropriations Act,
2024, Public Law 118-47, div. H, tit. V, sec. 507(d)(1), 138 Stat. 460,
703 (Mar. 23, 2024); the generally applicable requirements of RFRA, 42
U.S.C. 2000bb-1; and other applicable Federal laws.
Comment: Many commenters who supported OCR's proposal not to import
the title IX religious exception raised concerns that its importation
could discourage individuals from seeking necessary medical care. Many
commenters also discussed various State laws recently enacted to
further expand religious exemptions from health care requirements and
how such laws have specifically affected communities with limited
access to care. These commenters argued that the effects of these laws
further support OCR's goal of ensuring patients have broad access to
nondiscrimination protections.
Response: OCR appreciates commenters' concerns regarding the
potential harms to individuals with limited or restricted access to
health care. OCR appreciates that many religiously affiliated hospitals
and providers are providing vital services in areas where people are in
the most need and are often motivated by their faith to provide this
important care. However, OCR maintains that Congress did not choose to
import the title IX religious exception into section 1557. Importing
the title IX exception would be inconsistent with the text, structure,
and purpose of both title IX and section 1557. Rather, Congress has
enacted protections for conscience in the ACA itself; the Church,
Coats-Snowe, and Weldon Amendments, among others; the generally
applicable requirements of RFRA, and other applicable Federal laws as
the means to protect religious freedom and conscience in this context.
We are committed to affording full effect to Congress's protections of
conscience and religion, as detailed in Sec. 92.302 and the
Department's issuance of its final rule, Safeguarding the Rights of
Conscience as Protected by Federal Statutes. 89 FR 2078.
Comment: Multiple commenters opposed OCR's proposal not to import
the title IX religious exception, stating that doing so would harm
providers and hospital systems by compelling covered entities to
provide abortion or other care that is contrary to their religious
beliefs or that they believe will be harmful to their patients. Various
commenters said that compelling such actions would turn many
individuals and institutions of faith away from the medical profession.
Several commenters expressed confusion about available religious
exceptions and how certain rule requirements would apply to religiously
affiliated covered entities. These commenters said that including the
title IX religious exception would clarify protections for religious
entities.
Some commenters expressed concern that this regulation demonstrated
OCR's intent to use section 1557 to force religious hospitals to
dispense medication and perform procedures that are prohibited by their
faith. Several commenters objected to the inclusion of cites in the
2022 NPRM that explain the increased prevalence of religiously
affiliated health care systems and opined that this demonstrated
hostility toward faith-based providers. According to these commenters,
including these cites prejudices OCR's review of providers' religious
exemption requests. Instead, these commenters urged OCR to make clear
that providers will not be compelled to perform, cover, or promote
procedures or medical interventions to which they have moral or
religious objections.
Response: OCR appreciates commenters' concerns and respects their
opposition to the proposal not to import the title IX religious
exception. OCR reiterates, consistent with the 2022 NPRM, that this
final rule does not promote any particular medical treatment, require
provision of particular procedures, mandate coverage of any particular
care, or set any standard of care; rather, the final rule implements
the nondiscrimination requirements of section 1557. See 87 FR 47867-68.
The full protections of all Federal religious freedom and conscience
laws continue to apply.
Additionally, OCR makes clear that the decision not to import the
title IX religious exception does not compel any individual provider or
covered entity with religious or conscience-based objections to provide
abortion or any other care to the extent doing so would conflict with a
sincerely-held belief. The ACA itself provides that ``[n]othing in this
Act shall be construed to have any
[[Page 37534]]
effect on Federal laws regarding--(i) conscience protection; (ii)
willingness or refusal to provide abortion; and (iii) discrimination on
the basis of the willingness or refusal to provide, pay for, cover, or
refer for abortion or to provide or participate in training to provide
abortion.'' 42 U.S.C. 18023(c)(2)(A). As discussed further below,
section 1557 prohibits discrimination on the basis of race, color,
national origin, sex, age, or disability in covered health programs or
activities. A covered entity does not engage in discrimination
prohibited by section 1557 if it declines to provide abortions based on
religious or conscience objections to performing the procedure. In
addition, any recipient that believes that it is exempt from certain
provisions of this rule due to the application of a Federal conscience
or religious freedom law may rely on those provisions, as referenced in
Sec. 92.3(c), or choose to seek assurance of the applications of those
provisions pursuant to the process provided in Sec. 92.302.
In light of Sec. 92.302 and 42 U.S.C. 18023(c)(2)(A) (section 1303
of the ACA), OCR maintains that although some recipient providers and
hospitals may decline to participate in federally funded health
programs as a result of this rule, most will choose to continue to
participate. To avoid confusion, we have further clarified the process
for seeking assurance of an exemption based on religious freedom and
conscience laws at Sec. 92.302 and are committed to making available
trainings and other resources to assist covered entities in
understanding their obligations under section 1557 and the process by
which they may seek assurance of an exemption under Sec. 92.302.
Again, OCR appreciates that religiously affiliated hospitals and
health care facilities play an important role in the health care system
and recognizes the critical patient care needs they provide, including
in underserved communities and areas which otherwise lack access to
quality health care. Any discussion relating to the prevalence of
religiously affiliated care is relevant for OCR to evaluate access
issues that patients seeking certain procedures or care could
potentially face, although OCR does not assume that all religiously
affiliated entities' refusals to provide certain forms of care would
result in such access issues. As previously stated, the 2022 NPRM
provided factual findings with respect to health care accessibility in
the United States based upon health care capacity of providers,
population demands, and geographic limitations. 87 FR 47840. A detailed
discussion of these considerations can be found in the Regulatory
Impact Analysis (RIA).
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, OCR is finalizing the rule as proposed, without
importing the title IX religious exception.
Relationship to Other Laws (Sec. 92.3)
In Sec. 92.3, we provided an explanation of the relationship of
the proposed regulation to existing laws. Proposed Sec. 92.3(a)
provided that neither section 1557 nor this part shall be interpreted
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.
In Sec. 92.3(b), we proposed that nothing in this part shall be
interpreted to invalidate or limit the existing rights, remedies,
procedures, or legal standards available 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), consistent with 42 U.S.C. 18116(b).
In Sec. 92.3(c), we proposed that nothing in this part shall be
interpreted to invalidate or limit the existing rights, remedies,
procedures, or legal standards available under Federal religious
freedom and conscience laws. Though not specifically referenced in the
Proposed Rule, these include the protections in the ACA itself; the
Church, Coats-Snowe, and Weldon Amendments; the generally applicable
requirements of RFRA; and other applicable Federal laws.
The comments and our responses to this provision are set forth
below.
Comment: Commenters expressed a mix of viewpoints regarding the
``lesser standard'' language included in proposed Sec. 92.3(a),
concerning civil rights statutes referenced in section 1557. Some
commenters recommended removing the ``lesser standard'' language
because it is not included in the section 1557 statute. Commenters
stated that this language ignores Congress's decision to employ a
particular standard to each of the civil rights laws incorporated, such
that it would allow OCR to redefine bases for discrimination and
improperly preempt State law affecting such categories.
Response: In this final rule, OCR seeks to give all laws their
fullest possible effect. OCR appreciates these comments but declines to
remove the ``lesser standard'' language included in Sec. 92.3(a). As
the 2016 Rule recognized, 81 FR 31381, this interpretation is
consistent with a natural reading of section 1557's statutory text that
explicitly states that section 1557 shall not be construed to
``invalidate or limit the rights, remedies, procedures, or legal
standards'' of the referenced statutes (and title VII) ``or to
supersede State laws that provide additional protections against
discrimination,'' 42 U.S.C. 18116(b). OCR accordingly reaffirms that
the civil rights laws referenced in section 1557 establish the grounds
of prohibited discrimination, and nothing in this final rule is
intended to provide lesser protections than those found under title VI,
title IX, section 504, or the Age Act, or their implementing
regulations.
Comment: Several commenters supported the inclusion of the ``lesser
standard'' language in Sec. 92.3(a) but suggested that Sec. 92.3(c),
concerning Federal religious freedom and conscience laws, is
unnecessary and, if included without any limitations, undermines this
``lesser standard'' language of Sec. 92.3(a) and could encourage
discrimination.
Response: We decline to remove Sec. 92.3(c), concerning Federal
religious freedom and conscience laws. These laws remain applicable and
removing the language runs contrary to the Department and OCR's stated
commitment to protect the rights of individuals and entities under
Federal conscience or religion freedom laws. Indeed, the ACA itself
contains a similar provision at 42 U.S.C. 18023(c)(2)(A)(i), which
provides that ``[n]othing in this Act shall be construed to have any
effect on Federal laws regarding--conscience protection[.]'' As
discussed later in this section, we have revised Sec. 92.3(c) to
provide additional specificity regarding the application of Federal
religious freedom and conscience protections.
Comment: Some commenters suggested that OCR clarify that section
1557 does not limit the rights of individuals to any of the protections
afforded under title VI, title IX, section 504, or the Age Act. These
commenters suggested that section 1557 is a distinct law and, while it
is intended to work in tandem with other civil rights laws, section
1557 stands on its own. Several other commenters requested that the
final rule include language that clarifies that administrative
exhaustion is not required to bring any claim under section 1557 in
Federal court, where for example a claim may involve age as one basis
of discrimination among several (e.g., alleging discrimination on the
bases of age, sex, and disability at the same time) but the Age Act has
a
[[Page 37535]]
statutory requirement that claimants first exhaust their administrative
remedies.
Response: Section 92.3(b) clearly states that this part does not
limit or invalidate the rights, remedies, procedures, or legal
standards under the statutes referenced (i.e., title VI, title VII,
title IX, section 504, and the Age Act), consistent with the statutory
text of section 1557 at 42 U.S.C. 18116(b). In addition to
incorporating the ``ground[s] prohibited'' by these other statutes,
section 1557 incorporates the ``enforcement mechanisms'' of the
statutes. 42 U.S.C. 18116(a). 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 these statutes. Section 1557's nondiscrimination
requirements do not in any way limit or impact the interpretation of
those statutes. See id. at 18116(b). Section 1557 is a distinct civil
rights authority.
Courts have long recognized that section 1557 authorizes a private
right of action under any of the bases for discrimination. While we
appreciate concerns raised by commenters regarding the heightened risks
associated with unnecessary delays in the context of health care, we
decline to revise regulatory text to adopt a stance on the appropriate
standards that apply to private litigants. This is an issue
appropriately addressed by the Federal judicial branch and not via
agency rulemaking. Comments and responses regarding OCR procedures for
conducting its own administrative enforcement are provided in
Sec. Sec. 92.303 (Procedures for health programs and activities
conducted by recipients and State Exchanges) and 92.304 (Procedures for
health programs and activities administered by the Department).
Comment: Many commenters raised concerns about the potential
conflicts of State and Federal laws. Some commenters expressed that any
conflict between State and Federal law or policy would be inconsistent
with the principles of federalism. Some commenters had specific
concerns regarding the final rule's application to State laws that
prohibit transgender patients from receiving certain medically
necessary gender-affirming care or those that protect religious freedom
and conscience. Other commenters suggested that OCR should include a
subsection in the final rule that addresses the interaction between
section 1557 and State or local laws, making explicit that a State may
set more rigorous standards for nondiscrimination in the provision of
health care but not lesser protections than those of section 1557. To
the extent State or local law offers lesser protections these
commenters recommended OCR make explicit that such laws are preempted
by Federal law, consistent with the general preemption standard for
title I of the ACA, codified at 42 U.S.C. 18041(d).
Response: OCR appreciates these comments regarding the rule's
interaction with State and other Federal laws. We agree with commenters
who observed that Federal laws, as a general matter, preempt
conflicting State laws. See U.S. Const. art. 6, cl. 2. We also note
that title I of the ACA itself contains a preemption provision, which
courts have interpreted to preempt State laws that serve as an obstacle
to or frustrate the purpose of the ACA.\34\ See 42 U.S.C. 18041(d).
Accordingly, we decline to alter the regulation to include any
additional language under this provision addressing preemption. OCR
recognizes that some States may have laws impacting health programs and
activities that are contrary to the final rule's nondiscrimination
protections, and as discussed later regarding Sec. 92.206 (Equal
program access on the basis of sex), section 1557 preempts those laws,
though OCR will consider the specific facts of each case and any other
relevant factors in determining whether the recipient has a legitimate,
nondiscriminatory reason for taking actions that conflict with section
1557. OCR is adding Sec. 92.3(d) regarding State and local laws to
provide: ``Nothing in this part shall be construed to supersede State
or local laws that provide additional protections against
discrimination on any basis described in Sec. 92.1.''
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\34\ See St. Louis Effort for AIDS v. Huff, 782 F.3d 1016, 1021,
1024 (8th Cir. 2015) (partially affirming lower court preliminary
injunction because Missouri law ``frustrates Congress' purpose'' and
``pose[s] an obstacle to the accomplishment and execution of the
full purposes and objectives of Congress''); Coons v. Lew, 762 F.3d
891 (9th Cir. 2014), as amended, (Sept. 2, 2014) (``The Affordable
Care Act presents a classic case of preemption by implication
because the Arizona Act `stands as an obstacle to the accomplishment
and execution of the full purposes and objectives of Congress.' ''),
quoting Gade v. Nat'l Solid Wastes Mgmt. Ass'n, 505 U.S. 88, 98
(1992).
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Comment: Commenters recommended that OCR include in the final rule
clarification that the Emergency Medical Treatment and Labor Act
(EMTALA) protects emergency care for pregnancy and related conditions,
including termination of pregnancy.
Response: This rule concerns section 1557 and does not purport to
interpret or enforce EMTALA--indeed, OCR does not enforce EMTALA, nor
does EMTALA limit or expand the civil rights protections found in
section 1557.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.3, with modifications. We are revising Sec. 92.3(c) to
provide that, insofar as the application of any requirement under the
part would violate applicable Federal protections for religious freedom
and conscience, such application shall not be required. For example, 42
U.S.C. 18023 provides (among other things) that, nothing in section
1557 shall be construed to have any effect on Federal laws regarding
conscience protection; willingness or refusal to provide abortion; and
discrimination on the basis of the willingness or refusal to provide,
pay for, cover, or refer for abortion or to provide or participate in
training to provide abortion. We are also adding a new Sec. 92.3(d) to
provide that nothing in the part shall be construed to supersede State
or local laws that provide additional protections against
discrimination on any basis described in Sec. 92.1.
Definitions (Sec. 92.4)
In Sec. 92.4 of the Proposed Rule, we set out proposed definitions
of various terms. The comments and our responses regarding Sec. 92.4
are set forth below.
Auxiliary aids and services. The term auxiliary aids and services
was defined in the 2016 Rule and has not been changed substantively.
The proposed definition is consistent with the Americans with
Disabilities Act (ADA) regulations at 28 CFR 35.104 and 36.303(b) and
provides examples of auxiliary aids and services.
Comment: Commenters generally supported the definition of
``auxiliary aids and services.'' Some commenters recommended that the
final rule clarify that ``similar services and actions'' are available
for all individuals with disabilities, not just for individuals who are
deaf or hard of hearing and individuals who are blind or have low
vision.
Response: OCR appreciates this comment; however, effective
communication requirements are addressed in Sec. 92.202(a). As Sec.
92.4 is simply providing a definition for the term auxiliary aids and
services, which is used in Sec. 92.202(b), we do not believe
[[Page 37536]]
it is appropriate to adopt language suggested by the commenters.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``auxiliary aids
and services'' as proposed in Sec. 92.4, with one technical correction
in paragraph (1) to provide the correct cite for the title II
definition of ``qualified interpreter'' by striking ``36.303(b)'' and
replacing it with ``36.104.''
Companion. We proposed to define the ``companion'' to mean ``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.'' This term appeared in the 2016 Rule and has not been
changed substantively.
Comment: Many commenters support the inclusion of the term
``companion'' in the definitions section of the regulation, and some
highlighted that companions for persons with certain disabilities, such
as brain injuries and other conditions with cognitive effects, as well
as individuals with sensory disabilities, are critical to effective
communication of very sensitive and important medical information. Some
commenters suggested that OCR clarify that such companions should be
selected by the patient and not the provider.
Response: OCR appreciates the commenters' support for inclusion of
this definition. OCR declines to add additional language, as the
definition of ``companion'' in this rule is consistent with the
definition from 28 CFR 35.160(a)(2) under title II of the ADA, and with
the proposed definition in OCR's notice of proposed rulemaking for
section 504 at proposed 45 CFR 84.10.\35\ We agree that the individual
with a disability should be the one to determine who shall serve as
their companion absent any concerns of conflict of interest or
suspected abuse.
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\35\ See 88 FR 63392, 63465 (Sept. 14, 2023) (proposing to
define ``companion'' consistent with ADA title II regulations).
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``companion'' as
proposed in Sec. 92.4, without modification.
Federal financial assistance. We proposed to define the term
``Federal financial assistance'' to include grants, loans, and other
types of assistance from the Federal Government, consistent 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 proposed
to specifically include credits, subsidies, and contracts of insurance,
in accordance with the statutory language of section 1557. 42 U.S.C.
18116(a). Consistent with the 2016 Rule, we proposed including a clause
to clarify that Federal financial assistance includes Federal financial
assistance that the Department plays a role in providing or
administering.
Comment: Many commenters supported the inclusion of credits,
subsidies, contracts of insurance, and grants and loans in this
definition. Some commenters recommended expanding the definition of
``Federal financial assistance'' to include Federal disaster relief
loans and pandemic relief grants and loans.
Response: The definition of ``Federal financial assistance''
includes funds provided by the Federal Government, including grants and
loans, along with Federal financial assistance that the Department
plays a role in providing or administering. Because the types of funds
raised by the commenters already fall under the longstanding definition
of ``Federal financial assistance,'' and the inclusion of specific
types of Federal financial assistance would cause unnecessary confusion
and may be read as unintentionally limiting the scope of what
constitutes Federal financial assistance, we decline to revise the
definition.
Comment: Some commenters requested that OCR clarify whether tax-
exempt status is considered Federal financial assistance.
Response: OCR appreciates commenters' request for clarity.
Generally, tax benefits, tax exemptions, tax deductions, and most tax
credits are not included in the statutory or regulatory definitions of
Federal financial assistance. See, e.g., 42 U.S.C. 2000d-1 (title VI);
28 CFR. 42.102(c) (Department of Justice Title VI Regulation). Most
courts that have considered the issue have concluded that typical tax
benefits are not Federal financial assistance because they are not
contractual in nature.\36\
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\36\ See, e.g., Paralyzed Veterans of Am. v. Civil Aeronautics
Bd., 752 F.2d 694, 708-09 (D.C. Cir. 1985); Johnny's Icehouse, Inca
v. Amateur Hockey Ass'n of Ill., Inc., 134 F. Supp. 2d 965, 971-
7297172 (N.D. Ill. 2001); Chaplin v. Consol. Edison Co., 628 F.
Supp. 143, 145-46 (S.D.N.Y. 1986).
---------------------------------------------------------------------------
Comment: Many commenters supported the definition's inclusion of
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.'' \37\ A commenter
expressed support for this definition's application to funds extended
via programs operated by States under section 1332 State Innovation
Waivers, 42 U.S.C. 18052, which could include funds extended to issuers
receiving reimbursement through reinsurance programs and entities
participating in programs intended to modify or replace Exchanges that
would otherwise be within the scope of section 1557.
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\37\ See section 1412 of the ACA, codified at 42 U.S.C. 18082
(Advance determination and payment of premium tax credits and cost-
sharing reductions).
---------------------------------------------------------------------------
Response: OCR appreciates these comments and believes it is
important to explicitly state in regulatory text that funds that the
Department plays a role in providing or administering constitute
Federal financial assistance. As explained in the Proposed Rule, 87 FR
47843, this includes funds the Department administers with the
Department of the Treasury under the ACA, including advance payments of
the premium tax credit, cost-sharing reductions,\38\ and pass-through
funding available to States with approved section 1332 waivers. Thus,
an issuer participating in any Exchange that receives advance payments
of the premium tax credit or cost-sharing reductions on behalf of any
of its enrollees is receiving Federal financial assistance from the
Department.
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\38\ The Department is not currently making cost-sharing
reduction payments to issuers. See Memo. from Eric Hargan, Acting
Sec'y, U.S. Dep't of Health & Hum. 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. If the
Department begins making cost-sharing reduction payments in the
future, such payments would be considered Federal financial
assistance.
---------------------------------------------------------------------------
Section 1332 of the ACA permits a State to apply for a section 1332
waiver to pursue innovative strategies for providing residents with
access to high quality, affordable health insurance while retaining the
basic protections of the ACA. Section 1332 waiver funds constitute
Federal financial assistance and States receiving such funds are
recipients. As discussed in the 2022 NPRM, section 1332 allows States
to apply to HHS and the Department of the Treasury to waive certain ACA
requirements in the individual and small group markets if the waiver
satisfies certain statutory
[[Page 37537]]
requirements.\39\ 87 FR 47843. For example, under this provision,
several States have utilized section 1332 waivers to introduce new or
expanded plan options to consumers that lower premiums and/or expand
access to coverage, or implemented reinsurance programs to lower
premiums and stabilize the individual or small group market by
compensating issuers for eligible high-cost claims for enrollees with
significant medical costs. These State reinsurance programs use section
1332 pass-through funding to reimburse eligible issuers for high-cost
enrollees. These States establish reimbursement eligibility criteria
for issuers under the State's reinsurance program, which may include
payments to issuers offering coverage both on and off the Exchange.
Health insurance issuers receiving payments through a State's section
1332 waiver reinsurance program are subrecipients and therefore subject
to section 1557. To the extent a State's waiver utilizes pass-through
funding for provider reimbursement those providers would also be
subrecipients and subject to section 1557; however pass-through funding
received by individual consumers would not be subject to section 1557.
---------------------------------------------------------------------------
\39\ Sections 1332(a)-(b) of the ACA, codified at 42 U.S.C.
18052(a)-(b). States with approved waivers have specific terms and
conditions (STCs) pursuant to which 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 New Jersey's extension application for a section
1332 State Innovation Waiver, STC 4 (Aug. 15, 2023), https://www.cms.gov/files/document/1332-nj-extension-approval-letter-stcs-final.pdf.
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``Federal
financial assistance'' as proposed in Sec. 92.4, without modification.
Health program or activity. OCR proposed to adopt a definition of
``health program or activity.'' In paragraph (1), we proposed defining
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.
In paragraph (2), we proposed further defining ``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 (1)
(``principally engaged''). We proposed that whether such entities are
administered by a government or a private entity, all of their
operations would be covered under this part.\40\ We also invited
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.
---------------------------------------------------------------------------
\40\ See, e.g., Fain v. Crouch, 545 F. Supp. 3d 338, 343 (S.D.W.
Va. 2021), rehearing en banc granted, No. 22-1927 (4th Cir. Apr. 12,
2023) (oral argument held Sept. 21, 2023) (argued with Kadel v.
Folwell, No. 22-1721) (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'').
---------------------------------------------------------------------------
Comment: Commenters expressed a variety of views regarding the
application of the rule to health insurance issuers as health programs
or activities and the rule's application to all their operations when
principally engaged in any project, enterprise, venture, or undertaking
to provide or administer health-related services, health insurance
coverage, or other health-related coverage, as set forth under
paragraph (2) of the definition of ``health program or activity.''
Many commenters supported the inclusion of health insurance issuers
and coverage of all their operations when so principally engaged. These
commenters argued the 2020 Rule's approach, which applies to health
insurance issuers only to the extent a specific plan receives Federal
financial assistance, is contrary to the text of section 1557, the
CRRA, and the broad remedial intent of Congress in enacting the ACA to
ensure access to health insurance. Specifically, commenters argued the
2020 Rule is arbitrary and contrary to the plain language of section
1557, which applies to ``any health program or activity, any part of
which is receiving Federal financial assistance'' (emphasis added) and
specifically includes three examples of Federal financial assistance
that refer to health insurance (``credits, subsidies, or contracts of
insurance''). 42 U.S.C. 18116(a). This statutory language, commenters
argued, affirms that Congress intended section 1557 to apply to the
entire health program or activity, not just the parts that directly
receive Federal financial assistance. Commenters noted that the
statutory text should be construed broadly and stated that the Proposed
Rule's application to health insurance will align with the application
to all operations of other covered entities.
Many commenters raised objections to the 2020 Rule's provision at
Sec. 92.3(b) that covers all operations of an entity only when
principally engaged ``in the business of providing healthcare''
(emphasis added), in combination with Sec. 92.3(c) that specified a
health insurance issuer was not considered to be principally engaged in
the business of providing health care merely by virtue of providing
health insurance, which resulted in the 2020 Rule not covering all
operations of a recipient health insurance issuer. Commenters stated
this approach was inconsistent with Congress's approach in the CRRA,
which supports an expansive interpretation of section 1557's
application to cover all operations of a recipient if any part of it
receives Federal financial assistance. Specifically, one commenter
asserted that the section 1557 statute's use of the CRRA language
``program or activity'' and ``any part of which,'' coupled with the
statute's reference to title VI, title IX, section 504, and the Age
Act, demonstrate Congress's intent to adopt the same broad application
for section 1557. Commenters also argued the 2020 Rule's approach is
inconsistent with the text of section 1557, which broadly applies to
health programs or activities and is not limited to the delivery of
health care. Commenters challenged the 2020 Rule's contention that
health insurance is not health care, arguing that health insurance
issuers are in fact engaged in the business of health care and that
other parts of the ACA support this position. For example, ``health
care entity'' is defined to include ``a health insurance plan'' under
42 U.S.C. 18113(b) and 42 U.S.C. 300gg-91(b)(1) defines ``health
insurance coverage'' to mean benefits consisting of medical care.''
Among other things, commenters cited to section 1551 of the ACA, 42
U.S.C. 18111, which specifies that, unless otherwise indicated, the
definitions in 42 U.S.C. 300gg-91 apply to title I of the ACA.
Conversely, other commenters urged the Department to retain the
2020 Rule's approach, asserting that the CRRA limits the scope of
section 1557 with regard to all operations of a program or activity to
only those that are ``principally engaged in the business of providing
. . . healthcare'' (emphasis added).
Others argued that the Proposed Rule's application to health
insurance is
[[Page 37538]]
too broad and should not apply to all operations of a health insurance
issuer, particularly its lines of business that do not receive Federal
financial assistance. Specifically, commenters noted that because
health insurance issuers participate in some types of health insurance
that receive Federal financial assistance and other types that do not,
the Proposed Rule would require compliance even in activities that do
not benefit from Federal financial assistance. Commenters opined that
this interpretation goes beyond the scope of Congressional intent,
where Congress did not apply the protections to any entity engaging in
health programs and activities, but only to those health programs and
activities that specifically receive Federal financial assistance. One
organization asserted that the Proposed Rule could result in health
insurance issuers incurring substantial costs and declining to
participate in or withdrawing from the Exchanges, the Medicaid managed
care market, or the Medicare Advantage market, resulting in reduced
coverage options in those markets.
Response: In re-evaluating the 2020 Rule's interpretation of
``health program or activity'' as it relates to health insurance and in
deciding to add a definition of ``health program or activity,'' OCR
considered a number of factors, including the plain language of section
1557, the context of its placement within the ACA, long-standing civil
rights principles, and relevant case law.
The 2020 Rule does not include a definition of ``health program or
activity,'' but rather addresses the term under Sec. 92.3, the scope
of application section. The 2020 Rule provides that ``health program or
activity'' encompasses ``all of the operations of entities principally
engaged in the business of providing healthcare'' (emphasis added) and
specifies that a health insurance issuer is not considered to be
principally engaged in the business of providing health care merely by
virtue of providing health insurance. 45 CFR 92.3. The 2020 Rule
further provides that for entities not principally engaged in the
business of providing health care, their operations are only covered
under the rule to the extent such operation is a health program or
activity that receives Federal financial assistance. 45 CFR 92.3(b).
Thus, the 2020 Rule limits OCR's jurisdiction over health insurance
issuers to only their plans that directly receive Federal financial
assistance. This is in contrast to the 2016 Rule, which defined
``health program or activity'' to include all the operations of
entities principally engaged in health services, health insurance
coverage, or other health-related coverage, including health insurance
issuers, at former 45 CFR 92.4.
OCR agrees with commenters' assessment that the Proposed Rule's
approach to the inclusion of health insurance coverage and other
health-related coverage in the definition of ``health program or
activity'' is most consistent with section 1557's statutory text and
Congressional intent. The statutory text demonstrates Congress's clear
intent to apply section 1557 to health insurance coverage and other
health-related coverage. This statutory text does not support the 2020
Rule's limiting ``health program or activity'' to encompass all of the
operations of only those entities principally engaged in the business
of providing ``healthcare.'' Under the plain language of the statute,
section 1557 applies to any ``health'' program or activity not
``healthcare'' program or activity. And the provision of health
insurance coverage and other health-related coverage is plainly
classified under the term ``health.'' Private health insurance issuers
exercise significant control over enrollees' access to health care and
play a critical role in the business of health care, as insurance is an
essential component of ensuring that people receive care in the current
health care system. For example, a district court opinion on this issue
held that a health insurance issuer, by virtue of being the
``gatekeeper'' to the plaintiff's health services, qualified as a ``
`health program' that Congress intended to rid of discrimination.''
\41\
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\41\ Fain v. Crouch, 545 F. Supp. 3d 338, 342-43 (S.D.W. Va.
2021) (finding `` `health program or activity' under Section 1557
necessarily includes health insurance issuers'' and 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''), rehearing
en banc granted, No. 22-1927 (4th Cir. Apr. 12, 2023) (oral argument
held Sept. 21, 2023) (argued with Kadel v. Folwell, No. 22-1721).
---------------------------------------------------------------------------
Further, as we discussed in the Proposed Rule, 87 FR 47845, the
fact that Congress placed section 1557 in title I of the ACA, a title
that predominantly regulates health insurance coverage and other
health-related coverage with the purpose of increasing access to care
and reducing discriminatory insurance practices, demonstrates
Congress's intent for section 1557 to protect individuals from
discrimination in health insurance coverage and other health-related
coverage.
While not dispositive, we do appreciate commenters' thoughts on
whether health insurance issuers are in fact engaged in the business of
providing health care. Commenters among other things, cited to section
1551 of the ACA, which specifies that, unless otherwise indicated, the
definitions in 42 U.S.C. 300gg-91 shall apply with respect to title I
of the ACA. Section 300gg-91(b)(1) defines the term ``health insurance
coverage'' as ``benefits consisting of medical care (provided directly,
through insurance or reimbursement, or otherwise and including items
and services paid for as medical care) . . . .'' (Emphasis added.) The
2020 Rule specifies that ``medical care'' as used in that provision is
limited to the ``amounts paid for'' certain medical services and that a
health insurance issuer is not considered to be principally engaged in
the business of providing health care merely by virtue of providing
health insurance. However, the text of section 1557 does not support
the 2020 Rule's position that the rule applies only to the business of
providing ``healthcare.''
OCR found commenters' concerns regarding the negative consequences
that could result from the Proposed Rule's scope of application to
insurance issuers unpersuasive given the lack of information provided
to substantiate their concerns. For example, one commenter cited to
Exchange participation statistics that indicated certain issuers have
limited or no Exchange participation.\42\ However, the statistics do
not demonstrate the reason for such issuers' lack of participation or
provide evidence that an issuer's decision not to participate in an
Exchange was due to apprehension that section 1557 would apply to its
activities that did not receive Federal financial assistance.
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\42\ Mark Farrah Assocs., http://www.markfarrah.com (statistics
compiled using data from the National Association of Insurance
Commissioners, the California Department of Managed Health Care, and
CMS).
---------------------------------------------------------------------------
The application of civil rights laws to all operations of an entity
receiving Federal financial assistance is not new and did not originate
with section 1557. For more than 35 years, under the CRRA, a recipient
of Federal financial assistance that accepts Federal funds in any part
of its program has been required to comply with title VI, section 504,
and the Age Act in ``all of the[ir] operations.'' \43\ The CRRA
specifies that the entire program or activity, as defined in that
statute, is required to comply with title VI, section 504, and the Age
Act if any part of the program or activity receives Federal financial
[[Page 37539]]
assistance. We note that the terms ``program'' and ``program or
activity'' predate the CRRA in the underlying civil rights statutes,
and the legislative history of the CRRA indicates that Congress did not
believe it was enacting a new definition, but rather overturning an
overly narrow construction of the term by the Supreme Court and thereby
restoring what Congress and the executive branch had previously
understood to be a broad, institution-wide application of the term
``program.'' See S. Rep. No. 100-64 (1987). OCR maintains that Congress
adopted a similar approach in section 1557 by specifying in the statute
that section 1557 applies when ``any part of'' the health program or
activity receives Federal financial assistance.\44\ Entities must
comply with civil rights laws just as they must comply with any other
State or Federal law that is applicable to their operations.
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\43\ Public Law 100-259, 102 Stat. 29 (Mar. 1988), codified at
20 U.S.C. 1687; 29 U.S.C. 794(b); 42 U.S.C. 2000d-4(a); 6107(4).
\44\ Compare CRRA, 20 U.S.C. 1687(4) (``any part of which is
extended Federal financial assistance'') with section 1557, 42
U.S.C. 18116 (``any part of which is receiving Federal financial
assistance'').
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The 2020 Rule states it was applying the CRRA's definition of
``program or activity'' to cover all operations of entities under
section 1557 only when they are ``principally engaged in the business
of providing healthcare.'' We received some comments in support of the
approach in that rulemaking, and while we appreciate the importance of
the CRRA in shaping the interpretation of the scope of Federal civil
rights protections under title VI, section 504, title IX, and the Age
Act, it is not applicable here. Section 1557 employs the term ``program
or activity'' without adopting by reference the CRRA or any of the
underlying civil rights statutes. The 2020 Rule erred in applying the
CRRA to narrow the application of section 1557 by excluding a
significant portion of the health insurance industry. If Congress had
intended to limit section 1557 to entities principally engaged in the
business of providing ``healthcare,'' it could have provided as such in
the statute. Instead, the statute expressly modified ``program or
activity'' with ``health,'' without requiring that that entity be
``principally engaged in the business of providing healthcare.''
While Congress did not incorporate the CRRA into section 1557
wholesale, it stated that section 1557 applies to ``any health program
or activity, any part of which is receiving Federal financial
assistance.'' 42 U.S.C. 18116(a) (emphasis added). By modifying
``program or activity'' with ``health,'' and noting a health programs
or activity is covered if ``any part'' of it receives Federal financial
assistance, it is reasonable to infer that Congress intended the term
``health program or activity'' to be interpreted broadly and to include
all of that entity's operations, if the entity that receives Federal
funding is principally engaged in the provision or administration of
health insurance coverage or other health-related coverage. And because
``health program and activity'' is undefined in the section 1557
statute, it is also reasonable to infer that those health programs or
activities include health-related services, health insurance coverage,
or other health-related coverage.
Comment: One commenter argued that, because the CRRA delineates the
scope of coverage of section 1557's underlying civil rights statutes,
failing to include this limitation in the final rule would expand the
notion of Federal financial assistance to ultimate beneficiaries of the
funding and would have significant effect on other civil rights laws
dealing with funding, including title VI, title IX, and others.
Response: The commenter's concerns regarding interference with the
longstanding principle that Federal civil rights laws do not apply to
direct, unconditional assistance to ultimate beneficiaries are
unsupported. Ultimate beneficiaries are the intended class of private
individuals receiving Federal aid,\45\ a concept that is not impacted
or modified under this rulemaking. In fact, the definition of
``recipient'' in the final rule at Sec. 92.4 adopts standard language
that explicitly states that the term ``does not include any ultimate
beneficiary.''
---------------------------------------------------------------------------
\45\ U.S. Dep't of Justice, Title VI Legal Manual, section
V.C.2.F.
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Comment: OCR received comments specifically related to the rule's
application to health insurance issuers' other products and lines of
business that do not receive Federal financial assistance, such as
health insurance coverage sold off the Exchange, excepted benefits,
short-term, limited-duration insurance, and third party administrator
activities.
Response: These comments are addressed in the Scope of Application
discussion under Sec. 92.207 (Nondiscrimination in health insurance
coverage and other health-related coverage).
Comment: Some commenters, including an association representing
State insurance regulators, critiqued OCR's ``fungibility of funds''
rationale for including all operations of recipients that are
principally engaged in the provision or administration of health
insurance coverage. These commenters argued it is inappropriate to
consider funding to be fully fungible in the context of health
insurance, where issuers justify their premiums based on expected costs
in a particular market, not across all operations, and thus Federal
financial assistance for one type of coverage does not actuarially
support or subsidize an issuer's operations in other markets.
Commenters noted that entities have a myriad of corporate structures,
and that Federal funds received by one legal entity might not be shared
with sibling entities in unrelated business ventures. Commenters
pointed to the 2016 Rule's analysis regarding liability of third party
administrators, where OCR discussed that a third party administrator
that is legally separate from an issuer is unlikely to be covered under
the rule. 81 FR 31433.
Conversely, other commenters agreed with OCR's fungibility of funds
rationale, and argued that Federal financial assistance going to any
part of a health program or activity necessarily benefits the entity
receiving such funds as a whole. These commenters noted that a narrower
construction, in which nondiscrimination rules apply only to part of a
recipient, makes it easier for discriminatory actors to structure their
operations to evade responsibility and frustrates the purpose of the
statute.
Response: As commenters noted, OCR discussed the fungibility of
funds rationale as one means of support for the interpretation that all
of a health insurance issuer's operations will be covered by the final
rule when the health insurance issuer receives Federal financial
assistance. See 87 FR 47844. However, we note that reliance on this
rationale is not necessary to support OCR's interpretation that this
final rule applies to all of the operations of a recipient that is
``principally engaged,'' as discussed above. Under the best reading of
the statutory text, where an entity receives Federal financial
assistance and that entity is ``principally engaged in the provision or
administration of any health projects, enterprises, ventures, or
undertakings described in paragraph (1)'' of the definition of ``health
program or activity,'' the whole entity is defined as a health program
or activity covered under section 1557 and must comply with the final
rule.
We acknowledge that covered entities may structure their businesses
in a variety of ways. Unless an entity that is principally engaged can
demonstrate that part of their operations is truly a separate legal
entity, as discussed below, a recipient that is principally engaged is
liable for all its operations under the final rule.
[[Page 37540]]
Comment: One organization recommended that OCR explicitly identify
patient billing and collections activities as ``health programs or
activities'' by amending the definition to add a new paragraph (1)(vi)
as follows: ``provide or administer billing and collections services
for health-related services, including providing assistance to persons
to obtain financial help or counseling.''
Response: This final rule, consistent with OCR's other civil rights
implementing regulations, prohibits covered entities--directly or
through contractual or other arrangements--from discriminating in
patient billing and collection activities related to health programs
and activities. For example, a hospital's in-house administration of
billing would be covered and any contractual arrangement for
collections of debt would also be covered. We decline to add the
recommended language because it is unnecessary.
Comment: Many commenters strongly supported the Proposed Rule's
explicit inclusion of health research in the definition of ``health
program or activity.'' Some commenters recommended updating paragraph
(1)(iv) to include ``clinical'' research for clarity and to update
paragraph (2) to include: ``clinical trial sites including wherever
potential clinical trial participants are screened or recruited'' in
the list of entities considered ``principally engaged.'' In addition,
other commenters recommended that OCR provide technical guidance in
what ``inclusion'' in clinical research looks like and how it can be
achieved through nondiscriminatory research protocols.
Response: OCR supports the request to include clinical research in
the definition of ``health program and activity,'' and have revised
paragraph (1)(iv) accordingly. Clinical research is the comprehensive
study of the safety and effectiveness of the most promising advances in
patient care, and is different from laboratory research as it involves
people who volunteer to help the field better understand medicine and
health.\46\ However, we decline to add reference to physical sites, as
the jurisdiction applies to the health program or activity regardless
of where it takes place and whether it can be said to take place at a
site at all. For example, if a hospital receives a grant from the
National Institutes of Health to conduct a clinical study on the
effects of Tuberous Sclerosis Complex, the hospital is prohibited from
discriminating in its screening and recruitment activities wherever
they take place, such as at the hospital itself, at community health
fairs, online, or at the home of a hospital researcher who is working
out of their own home.
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\46\ John Hopkins Medicine, Research, Understanding Clinical
Trials, Clinical Research: What Is It?, https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-what-is-it.html.
---------------------------------------------------------------------------
Comment: One organizational commenter requested that OCR clarify
section 1557's application to health research projects and activities
to explicitly recognize that health research is conducted to answer
specific questions, and that research protocols may target or exclude
certain populations where nondiscriminatory justifications show that
such criteria are appropriate, consistent with the 2016 Rule preamble.
Response: Consistent with the 2016 Rule, OCR does not intend the
inclusion of health or clinical research within the definition of
``health program or activity'' to alter the fundamental nature in which
research projects are designed, conducted, or funded. 81 FR 31385. As
in the 2016 Rule, we note that criteria in research protocols that
target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are
appropriate with respect to the health or safety of the subjects, the
scientific study design, or the purpose of the research. See 81 FR
31385.
Comment: Some commenters recommended that OCR narrow the definition
of ``health program or activity'' to exclude programs and activities
unrelated to health. These commenters also requested that OCR clarify
what ``any project, enterprise, venture or undertaking to provide or
administer health-related services'' means. For example, these
commenters were unclear whether a health-related venture may include
such things as vitamin manufacturing.
Response: The final rule applies to health programs and activities
that receive Federal financial assistance from the Department (or that
are administered by the Department or a title I entity) and does not
apply generally to programs and activities that are unrelated to
health. However, where an entity is principally engaged as set forth in
paragraph (2) of the definition of ``health program or activity,'' all
operations of the covered entity must comply with the final rule. This
applies even where the covered entities' other operations are not
necessarily health-related.
Though not an exhaustive list, ``health-related service'' would
include the provision of medical, dental, and pharmaceutical care;
preventive health services; physical, occupational, or speech therapy;
behavioral health care; clinical trials; and transportation to and from
such services when necessary to facilitate access to other health-
related services.\47\ Should an entity engaged in commercial vitamin
manufacturing receive Federal financial assistance from the Department,
OCR would conduct an analysis as to whether the program or activity in
question meets the definition of ``health program or activity.''
---------------------------------------------------------------------------
\47\ See, e.g., 42 CFR 431.53 (requiring a state Medicaid plan
to specify that the Medicaid agency will ensure ``necessary
transportation for beneficiaries to and from providers'').
---------------------------------------------------------------------------
Comment: A few commenters urged the Department to expressly list
Medicaid programs, Children's Health Insurance Program (CHIP), or the
Basic Health Program in its definition for ``health program or
activity.''
Response: The 2016 Rule included Medicaid programs, CHIP and the
Basic Health Program in its definition of ``health program or
activity'' at former 45 CFR 92.4. As stated in the preamble to the 2022
NPRM, these entities would be covered in their entirety as operations
of State or local health agencies and we sought comment on whether such
programs should be explicitly referenced in the regulatory language. 87
FR 47844. For clarity and to reduce confusion, OCR accepts the
recommendation to include State Medicaid programs, CHIP, and the Basic
Health Program in paragraph (2) of the definition of ``health program
or activity.''
Comment: Numerous commenters objected to the 2022 NPRM's proposal
to not explicitly include group health plans \48\ in the list of
entities considered to be principally engaged in paragraph (2) of the
``health program or activity''
[[Page 37541]]
definition. Expressing concerns that this would result in confusion
that the rule excludes group health plans, commenters urged OCR to
reinstate the 2016 Rule's approach by expressly including group health
plans in the definition of ``health program or activity.'' Former 45
CFR 92.4.
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\48\ ``Group health plan'' is defined in the Employee Retirement
Income Security Act (ERISA) 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 26 U.S.C.
9831(d)(2)). 29 U.S.C. 1191b(a)(1); see also 42 U.S.C. 300gg-
91(a)(1). ``Employee welfare benefit plan'' is defined in ERISA 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 29 U.S.C. 186(c) (other than pensions on retirement or
death, and insurance to provide such pensions). 29 U.S.C. 1002(1).
---------------------------------------------------------------------------
Commenters further suggested that the rule clarify that group
health plans are covered entities when the group health plan itself
receives Federal financial assistance or when the employer sponsoring
the group health plan receives Federal financial assistance, such as
through an Employer Group Waiver Plan (EGWP) or Retiree Drug Subsidy
(RDS) plan. Some commenters argued that an employer and a group health
plan should not be treated as distinct entities for purposes of section
1557 jurisdiction, and that group health plans should be considered
indirect recipients of Federal financial assistance when the employer
receives Federal funds.
Other commenters stated that employers are usually the sponsors of
group health plans and were concerned that OCR's case-by-case analysis
may find an employer liable under section 1557 based on the employee
benefits it provides. Several commenters expressed concerns with OCR's
proposed approach to conduct a case-by-case review to determine whether
a group health plan is a covered entity and requested that OCR provide
additional clarity on when employers and group health plans are liable
under the rule.
Response: Commenters' concerns that group health plans would never
be subject to the rule if they are not expressly included in the
definition of ``health program or activity'' are unwarranted. The list
of entities included as principally engaged, at paragraph (2), is not
exhaustive. The fact that a group health plan is not expressly included
in paragraph (2) does not affect the determination of whether a group
health plan is principally engaged under this definition. As group
health plans provide or administer group health coverage, they would be
operating a health program or activity under the rule and would be
subject to this rule if in receipt of Federal financial assistance.
Further, recipient group health plans, like health insurance issuers,
would be considered to be principally engaged in the provision or
administration of health insurance coverage or other health-related
coverage, meaning all their operations would be covered.
In the 2022 NPRM, we declined to expressly include group health
plans in the definition of ``health program or activity'' in an attempt
to reduce confusion because many group health plans do not receive
Federal financial assistance. 87 FR 47845. It remains OCR's
understanding that many group health plans do not receive Federal
financial assistance, and thus we decline commenters' request to add
group health plans to the non-exhaustive list of entities that are
considered principally engaged that is provided in paragraph (2) of the
definition of ``health program or activity.''
A group health plan that receives Federal financial assistance
itself is distinct from other entities that might separately receive
Federal financial assistance, such as the plan sponsor of the group
health plan or the third party administrator administering the plan. As
such, a group health plan does not necessarily become a covered entity
under this rule by virtue of the plan sponsor or third party
administrator's receipt of Federal financial assistance. Single
employers that are plan sponsors of single-employer group health plans
and joint boards of trustees or similar bodies, associations, and other
groups that are plan sponsors of multiemployer Taft-Hartley plans or
multiple employer welfare arrangements (MEWAs) do not become covered
entities under the rule due to their employment practices, including
the provision of employee health benefits. Later in this section, we
address how OCR will determine whether related business entities are
considered separate legal entities under section 1557.
When OCR receives a complaint alleging discrimination related to a
group health plan, we will conduct a fact-specific analysis to
determine if the group health plan is a recipient or subrecipient of
Federal financial assistance. We decline to take the position that a
group health plan is an indirect recipient of Federal financial
assistance whenever the plan sponsor receives Federal financial
assistance. Determining whether an entity is an indirect recipient
requires a fact-specific inquiry.\49\
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\49\ See, e.g., Doe One v. CVS Pharmacy, Inc., No. 18-CV-01031-
EMC, 2022 WL 3139516, slip op. at 7, 9 (N.D. Cal. Aug. 5, 2022)
(analyzing whether defendant pharmacy benefit manager is an indirect
recipient of Federal financial assistance from defendant pharmacy
chain and, relying on the section 1557 statute and 2020 Rule,
holding that CVS Pharmacy, Inc. is principally engaged in the
business of health care and all of its operations are covered by
section 1557, including its pharmacy benefit managers Caremark,
L.L.C. and Caremark PCS Health, L.L.C.).
---------------------------------------------------------------------------
Entities that receive Federal financial assistance from the
Department for an EGWP or RDS plan would be subject to this rule,
though we note that employers and other plan sponsors are not subject
to this rule with regard to their employment practices, pursuant to
Sec. 92.2(b). This includes when the Federal financial assistance
received is for their employee health benefits. For more information
about employer and plan sponsor liability, see the previous discussion
under Sec. 92.2(b).
In addition, as noted in the Proposed Rule, covered entities that
contract with a group health plan could be subject to this rule
themselves, regardless of the group health plan's liability. For
instance, recipient health insurance issuers may be covered under this
rule when offering health insurance coverage to a fully-insured group
health plan or when providing third party administrator services for a
self-funded group health plan.\50\ We also noted in the Proposed Rule
at 87 FR 47845 that even if a group health plan is not subject to
section 1557, group health plans may be subject to other Federal
nondiscrimination requirements.\51\
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\50\ 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); C.P. v.
Blue Cross Blue Shield of Ill., No. 20-cv-6145, 2022 WL 17788148,
*7-9 (W.D. Wash. Dec. 19, 2022) (relying on the section 1557 statute
because the ``2020 Rule is contrary to the statutory law, and the
rule appears to be arbitrary, capricious and contrary to law,'' and
holding that a health insurance issuer acting as a third party
administrator for a self-funded employer-provided plan is a covered
entity under section 1557, regardless of whether the discriminatory
exclusion originated with the third party administrator, and ERISA's
requirement that decisions be made in accordance with the plan
documents is no defense as ERISA expressly provides that it is not
to be construed to invalidate or impair Federal laws like section
1557).
\51\ For example, group health plans and health insurance
issuers offering group or individual health insurance coverage are
generally prohibited from establishing any rule for eligibility,
benefits, or premiums or contributions that discriminates based on
any health factor. 26 U.S.C. 9802: 29 U.S.C. 1182; 42 U.S.C. 300gg-
4; 26 CFR 54.9802-1; 29 CFR 2590.702; 45 CFR 146.121, 147.110.
---------------------------------------------------------------------------
Comment: Some commenters urged OCR to expressly include pharmacy
benefit managers in the definition of ``health program or activity.''
Commenters argued it was important to do so because pharmacy benefit
managers play a significant role in developing and administering
prescription drug benefits, and section 1557 can serve to prevent
certain practices that may result in discriminatory access to
medications, such as coverage criteria, utilization management
practices, limitations on
[[Page 37542]]
where medicines can be dispensed, and high out of pocket costs.
Response: We decline to list pharmacy benefit managers expressly in
paragraph (2) of the definition of ``health program or activity.''
Pharmacy benefit managers are entities that manage prescription drug
benefits for issuers, group health plans, Medicare Part D drug plans,
and other payers, such as State Medicaid programs (collectively known
as ``payers'').\52\ In their role of administering prescription drug
benefits on behalf of payers, pharmacy benefit managers develop drug
formularies and related policies, create pharmacy networks, reimburse
pharmacies for patients' prescriptions, negotiate rebates and fees with
drug manufacturers, process enrollees' claims and appeals, and review
drug utilization, among other things.\53\ These activities constitute
the operation of health programs and activities under section 1557.
---------------------------------------------------------------------------
\52\ Staff of H. Comm. on Oversight & Reform, 117th Cong., A
View from Congress: Role of Pharmacy Benefit Managers in
Pharmaceutical Markets, 6 (Dec. 10, 2021), https://oversight.house.gov/wp-content/uploads/2021/12/PBM-Report-12102021.pdf.
\53\ See, e.g., U.S. Gov't Accountability Off., GAO 19-19-498,
Medicare Part D: Use of Pharmacy Benefit Managers and Efforts to
Manage Drug Expenditures and Utilization, 14-15, 39-42 (2019),
https://www.gao.gov/assets/gao-19-498.pdf; Visante, Pharmacy Benefit
Managers (PBMs): Generating Savings for Plan Sponsors and Consumers,
pp. 3-4 (2023), https://www.pcmanet.org/wp-content/uploads/2023/01/Pharmacy-Benefit-Managers-PBMs-Generating-Savings-for-Plan-Sponsors-and-Consumers-January-2023.pdf.
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If pharmacy benefit managers receive Federal financial assistance
from the Department, either directly or indirectly, they are subject to
this rule. Further, if they are principally engaged under paragraph
(2), all their operations are covered by the rule.
As discussed previously, the fact that a type of entity--such as a
pharmacy benefit manager--is not expressly included in the definition
of ``health program or activity'' does not mean that those entities are
excluded from the rule or could never be subject to section 1557
jurisdiction. Even if a pharmacy benefit manager does not receive
direct Federal financial assistance, we note that the three largest
pharmacy benefit managers are integrated with large health insurance or
pharmacy companies, and thus could be covered under the rule as part of
the operations of a health program or activity receiving Federal
financial assistance.\54\ Determining whether a pharmacy benefit
manager is subject to the rule as part of the operations of a recipient
health program or activity is a fact-specific analysis based on the
corporate structure of the entity.
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\54\ See Doe One v. CVS Pharmacy, Inc., No. 18-cv-01031-EMC,
2022 WL 3139516, slip op. at 7, 9 (N.D. Cal., Aug. 5, 2022) (relying
on the section 1557 statute and 2020 Rule when finding that CVS
Pharmacy, Inc. is principally engaged in the business of health care
and all of its operations are covered by section 1557, including its
pharmacy benefit managers Caremark, L.L.C. and Caremark PCS Health,
L.L.C.).
---------------------------------------------------------------------------
Comment: Commenters requested that OCR provide more clarity on how
it will analyze whether corporate subsidiaries and related business
entities are subject to section 1557 as part of a covered entity's
operations. Specifically, some commenters were concerned about health
insurance issuers that receive Federal financial assistance avoiding
responsibility through use of subsidiaries in their other activities,
such as third party administrators or pharmacy benefit managers.
Conversely, other commenters expressed concerns that the rule would
apply too broadly to an issuer's business ventures that are unrelated
to their federally funded activities.
Response: As stated throughout this section, if any part of a
health program or activity receives Federal financial assistance and
the entity administering said health program or activity is principally
engaged as provided in paragraph (2), then all the operations of the
recipient are subject to the rule. If a part of a recipient's
operations is determined to be a separate legal entity independent from
its federally funded activities, that part would not be subject to the
rule. When determining whether an entity's subsidiaries or other
entities are legally separate from the federally funded activities, OCR
may consider--among other things--the organizational structure and the
interrelatedness between the entities, such as the degree of common
ownership, management, and control between the entities, and whether
the entities share centralized control of labor relations; whether the
entity has some ability to accept or reject the Federal funding or
exercise controlling authority over a federally funded program; \55\
and whether the purpose of the legal separation was to avoid liability
or avoid the application of civil rights law requirements, meaning it
is intended to allow the entity to continue to discriminate.\56\
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\55\ See id. Cf. Papa v. Katy Indus., Inc., 166 F.3d 937, 939
(7th Cir. 1999), cert. denied, 528 U.S. 1019 (1999) (ADA, ADEA);
Arrowsmith v. Shelbourne, Inc., 69 F.3d 1235, 1240-42 (2d Cir. 1995)
(title VII); Valesky v. Aquinas Acad., 2011 U.S. Dist. LEXIS 103791,
No. 09-800 (W.D. Pa. Sept. 14, 2011) (title IX); Russo v Diocese of
Greenberg, 2010 U.S. Dist. LEXIS 96338, No. 09-1169 (W.D. Pa. Sept.
15, 2010) (title IX, section 504); Margeson v. Springfield Terminal
Railway Co., 1993 U.S. Dist. LEXIS 12243, No. CIV.A. 91-11475-Z (D.
Mass. Aug. 24, 1993) (section 504).
\56\ Papa v. Katy Indus., Inc., 166 F.3d 937, 941 (7th Cir.
1999), cert. denied, 528 U.S. 1019 (1999).
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``health program
or activity'' as proposed in Sec. 92.4, with modifications. We have
revised paragraph (1)(iv) to include clinical research, such that it
will now read: ``Engage in health or clinical research.'' We have also
revised paragraph (2) to include ``a State Medicaid program, Children's
Health Insurance Program, and Basic Health Program'' as examples of
entities principally engaged under this definition.
Information and communication technology (ICT). We proposed to
define the term ``ICT'' to mean ``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.'' We also provided examples of ICT in our proposed
definition.
Comment: Some commenters urged OCR to include ``electronic health
records (EHRs)'' as an example within the definition of ``information
and communication technology''.
Response: We appreciate that there are many different examples that
can fit within the definition of ``information and communication
technology''. We agree that EHRs meet the definition of ``information
and communication technology''; however, we believe that it is
unnecessary to specify this in the final rule.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``information
and communication technology'' as proposed in Sec. 92.4, without
modification.
Language assistance services. OCR proposed to define the term
``language assistance services'' to include, but not be 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 services of
qualified bilingual or multilingual staff to communicate directly with
limited English proficient
[[Page 37543]]
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. The definitions of oral language
assistance and written translation appeared in both the 2016 Rule at
former Sec. 92.4 and the 2020 Rule at Sec. 92.101 in paragraphs
(2)(i) and (iii) and have not been changed. The 2016 Rule did not
explicitly include a written notice of availability of language
assistance services in the definition of ``language assistance
services,'' but rather included the term ``taglines,'' which was
defined to mean ``short statements written in non-English languages
that indicate the availability of language assistance services free of
charge.''
Comment: One commenter recommended that the definition of
``language assistance services'' include assistance with form
completion in another language. The commenter noted that many
individuals with limited English proficiency (LEP) as well as many
others (including older individuals and those with limited access to
technology) have difficulty completing online forms to apply for health
benefits or report life changes.
Response: OCR appreciates the suggestion and agrees it is critical
for individuals with LEP to receive language assistance in completing
forms. The definition of ``language assistance services'' is intended
to provide a non-exhaustive list of some of the means by which a
covered entity may facilitate such access--namely, oral interpretation
and written translation as provided by qualified interpreters and
translators, respectively. This definition works together with the
requirements at Sec. 92.201, which provide that covered entities must
take reasonable steps to provide meaningful access to individuals with
LEP. If an individual with LEP needs assistance with form completion in
a covered health program or activity, a covered entity must provide
language assistance services consistent with the requirements at Sec.
92.201. OCR declines to modify the definition of ``language assistance
services'' as suggested because the context in which services are
provided is not germane to the definition.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``language
assistance services'' as proposed in Sec. 92.4, with modification. As
discussed in the following summary of regulatory changes to the
proposed term ``limited English proficient individual,'' we are
revising the term to ``individual with limited English proficiency'' in
Sec. 92.4.
Limited English proficient individual. OCR proposed to define the
term ``limited English proficient individual'' to mean ``an individual
whose primary language for communication is not English and who has a
limited ability to read, write, speak, or understand English.''
Further, OCR proposed that 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).'' These definitions appeared
in the 2016 Rule and have not changed substantively. Former 45 CFR 92.4
(2016 Rule). OCR sought comment on whether to use the term ``limited
English proficient individual'' or ``individual with limited English
proficiency'' throughout the rule.
Comment: Some commenters recommended the final rule adopt the
language either ``people with limited English proficiency'' or
``individual with limited English proficiency'' instead of ``limited
English proficient individual.''
Response: OCR agrees with this recommendation and OCR is finalizing
the rule with the term ``individual with limited English proficiency''
throughout.
Comment: Several commenters supported the proposed definition's
emphasis that an individual with LEP includes those who may be
competent in English for certain types of communication but still have
limited English proficiency for other purposes. Commenters explained
that this will ensure providers and other covered entities understand
that people who have some English competency may still need translated
written materials. Commenters noted this will improve language access
and have far-reaching consequences for patients who both seek and
receive care, which will also reduce barriers to quality health care
for individuals with LEP.
Response: We appreciate the support of inclusion of additional
details around what it means to be ``limited English proficient'' and
are finalizing the definition as proposed.
Comment: A few commenters that agreed with the proposed definition
urged that the word ``and'' be replaced with ``or'' to read ``an
individual whose primary language for communication is not English or
who has a limited ability to read, write, speak, or understand English
. . .'' These commenters explained that there are many people in the
United States whose primary language is English but who have a limited
ability to read, write, speak, or understand English, for reasons that
may or may not be related to disability, who deserve protection from
discrimination.
Response: OCR appreciates the commenters' recommendation and
recognizes that there are many individuals whose primary language is
English but who have a limited ability to read, write, speak, or
understand English. However, section 1557's language access provisions
rely on the statute's prohibition on national origin
discrimination.\57\ For individuals with LEP, the lack of proficiency
in English and the use of non-English languages is often tied to their
national origin. Changing the definition to include an individual who
has a limited ability to read, write, speak, or understand English, but
whose primary language is English, would go beyond national origin
discrimination. With respect to individuals who have a limited ability
to read, write, speak, or understand English related to disability,
Sec. 92.202 addresses requirements for effective communication for
individuals with disabilities, which is a long-standing requirement.
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\57\ See Lau v. Nichols, 414 U.S. 563, 568-69 (1974).
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``limited
English proficient individual'' as proposed in Sec. 92.4, with
modification. We are changing ``limited English proficient individual''
to ``individual with limited English proficiency'' in Sec. 92.4 and
throughout the final rule.
Machine translation. OCR proposed to define the term ``machine
translation'' to mean ``automated translation, 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.'' Neither the 2016 Rule nor the
2020 Rule addressed machine translation. We invited comment on the
adequacy of this new definition.
Comment: We received many comments in support of the inclusion of a
definition of ``machine translation''. One commenter supported the
language as proposed but noted the importance of adaptability and
potential for future regulation or guidance over time as
[[Page 37544]]
technology changes. For example, machine translation companies may
develop technology that includes some level of human review but remains
insufficient for the purposes of conforming with the intent of this
rule.
Response: We appreciate commenters' support for the inclusion of
this definition. The requirement to provide written translations via a
qualified translator included at Sec. 92.201(c)(2) continues to apply,
regardless of whether human or machine translation is provided. Section
92.201(c)(3) requires a human translator to review machine translation
under certain circumstances. The circumstances outlined in Sec.
92.201(c)(3) set a minimum requirement for when machine translations
must be reviewed by a qualified human translator--including
circumstances that are critical to one's rights or benefits. Thus, any
machine translation technologies that are developed must include such
review if they are to meet the requirements of this rule. OCR will
continue to monitor the progression of this technology and will revisit
regulatory updates as well as consider issuance of future guidance as
needed.
Comment: One commenter stated that the definition of ``machine
translation'' should include reference to the use of software or
automated tools. Specifically, the commenter recommended modifying the
language to read ``machine translation is the use of automated
translation software or tools, without the assistance of . . .''
Response: OCR appreciates the commenter's suggestion to explicitly
refer to software or automated tools; however, the definition as
proposed sufficiently accounts for translations that would be generated
by software or automated tools as it refers to ``automated
translation.''
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``machine
translation'' as proposed in Sec. 92.4, with modification. We are
making a technical correction to change ``automated translations'' to
``automated translation.''
National Origin. We proposed to define the term ``national origin''
to mean ``a person's, or their ancestor's, place of origin or a
person's manifestation of the physical, cultural, or linguistic
characteristics of a national origin group.'' This is consistent with
the 2016 Rule's definition of ``national origin,'' and with the well-
established definition of the term that the Equal Employment
Opportunity Commission (EEOC) uses in its interpretation of title
VII.\58\
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\58\ 29 CFR 1606.1; see, also, U.S. Equal Emp. Opportunity
Comm'n, EEOC Enforcement Guidance on National Origin Discrimination,
https://www.eeoc.gov/laws/guidance/eeoc-enforcement-guidance-national-origin-discrimination#_Toc451518799.
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Comment: Various commenters discussed the need to include this
definition to address entrenched inequities and practices that can
constitute national origin discrimination but are not always
recognized. This includes the failure to take reasonable steps to
provide meaningful access for individuals with LEP, even though such a
failure has been long recognized as a form of national origin
discrimination. Commenters added that there are also clear
intersections between LEP status and race and ethnicity because the
great majority of individuals with LEP are people of color; however,
they noted that when individuals seek to vindicate their civil rights,
they often must choose between pursuing a claim based on either their
LEP status or race. Commenters also provided examples of how some
people have been denied benefits they are entitled to due to national
original discrimination. Several national organizations and local
service providers commented that refugees, migrant workers, and other
immigrants experience barriers to federally funded or provided health
care due to fears related to their immigration status.
Response: OCR appreciates commenters' support for inclusion of this
definition. We recognize that individuals can experience both national
origin and race discrimination (or national origin discrimination and
discrimination on another protected basis) and are finalizing new
regulatory language that provides additional clarity and addresses such
instances in which individuals may experience discrimination under
multiple bases. See discussion regarding Sec. 92.101.
OCR appreciates comments related to immigration status. While
section 1557 does not prohibit discrimination on the basis of
immigration status, we note that differential treatment such as
requiring additional verification or documentation from individuals
based on their appearance, name, accent, LEP, or suspected immigration
status may violate section 1557 and other civil rights laws.\59\
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\59\ See, e.g., U.S. Dep't of Justice, Guidance to State and
Local Governments and Other Federally Assisted Recipients Engaged in
Emergency Preparedness, Response, Mitigation, and Recovery
Activities on Compliance with Title VI of the Civil Rights Act of
1964, Section D, https://www.justice.gov/crt/fcs/EmergenciesGuidance.
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``national
origin'' as proposed in Sec. 92.4, with modification. We are making a
technical correction to change ``ancestor's'' to ``ancestors'.''
Patient care decision support tool. The Proposed Rule described but
did not include a definition in Sec. 92.4 for, the term ``clinical
algorithms.'' See 87 FR 47880. Many commenters supported the inclusion
of a provision such as proposed Sec. 92.210, addressing
nondiscrimination in the use of clinical algorithms in decision-making,
but recommended OCR clarify that the provision applies to tools used to
assess health status, recommend care, determine eligibility, allocate
resources, conduct utilization review, and provide disease management
guidance. Further, commenters requested that OCR define what tools are
covered under Sec. 92.210.
Based on comments received, we are replacing the term ``clinical
algorithm'' with the more precise term ``patient care decision support
tool,'' and we are adding a definition for ``patient care decision
support tool'' to mean ``any automated or non-automated tool,
mechanism, method, technology, or combination thereof used by a covered
entity to support clinical decision-making in its health programs or
activities.'' The definition of ``patient care decision support tool''
reaffirms that Sec. 92.210 applies to tools used in clinical decision-
making that affect the care that patients receive. This includes tools,
described in the Proposed Rule, used by covered entities such as
hospitals, providers, and payers (health insurance issuers) in their
health programs and activities for ``screening, risk prediction,
diagnosis, prognosis, clinical decision-making, treatment planning,
health care operations, and allocation of resources'' as applied to the
patient. 87 FR 47880. We clarify that tools used for these activities
include tools used in covered entities' health programs and activities
to assess health status, recommend care, provide disease management
guidance, determine eligibility and conduct utilization review \60\
related to patient care that is
[[Page 37545]]
directed by a provider, among other things, all of which impact
clinical decision-making. Please see our discussion regarding Sec.
92.210, where we discuss ``patient care decision support tool'' in more
detail, including examples of tools to which Sec. 92.210 does not
apply.
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\60\ See, e.g., Patrick Rucker et al., How Cigna Saves Millions
by Having Its Doctors Reject Claims Without Reading Them, ProPublica
(March 25, 2023), https://www.propublica.org/article/cigna-pxdx-medical-health-insurance-rejection-claims; Casey Ross & Bob Herman,
Denied by AI: How Medicare Advantage Plans Use Algorithms to Cut Off
Care for Seniors in Need, STAT News (March 13, 2023), https://www.statnews.com/2023/03/13/medicare-advantage-plans-denial-artificial-intelligence/.
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Summary of Regulatory Changes
Considering the comments received, we are finalizing the definition
of ``patient care decision support tool'' in Sec. 92.4 to mean ``any
automated or non-automated tool, mechanism, method, technology, or
combination thereof used by a covered entity to support clinical
decision-making in its health programs or activities.''
Qualified Bilingual/Multilingual Staff. OCR proposed to define the
term ``qualified bilingual/multilingual staff'' to mean a member of a
covered entity's workforce who is designated by the covered entity to
provide oral language assistance directly to an individual in their
primary language 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
individuals with LEP in their primary language.
Comment: Some commenters urged that additional attention should be
given to assessing qualifications for self-identified bilingual/
multilingual staff abilities to provide services in languages other
than English, and that policies and procedures should be developed to
assess and retain their competency. Additionally, some commenters
recommended establishing qualifications for bilingual/multilingual
staff who may also be expected to serve as interpreters, and added that
they should be compensated appropriately. Commenters stated that
research has shown that bilingual staff who are not qualified
interpreters often do not feel comfortable serving as interpreters. A
commenter posited that bilingual/multilingual staff must be provided
training and compensation opportunities to support professional
development and prevent staff turnover and burnout.
Response: OCR appreciates the commenters' suggestions to establish
assessment requirements for qualified bilingual/multilingual staff;
however, we believe the current definition establishes sufficient
requirements and guidelines regarding the necessary skills a qualified
bilingual/multilingual staff member must have. The definition sets
forth a two-prong definition to ensure proficiency, effectiveness, and
impartiality in direct communications with individuals with LEP in
their primary languages, including any necessary specialized
vocabulary, terminology, and phraseology. Similar to the rule's
definitions for qualified interpreters and qualified translators, OCR
has established the necessary skills that must be held to meet the
definition, while providing covered entities the flexibility by which
to have these skills assessed. We note that an individual's self-
identification as bilingual or multilingual alone is insufficient to
determine whether they meet this definition, and covered entities
should determine processes by which they will independently determine
and periodically assess an individual's qualifications.
While qualified bilingual/multilingual employees may also be
qualified interpreters, the ability to interpret is a separate skill.
Anyone whom a covered entity allows to serve as an interpreter must be
qualified to do so, consistent with the definition of ``qualified
interpreter for an individual with limited English proficiency'' in
this section, independent of whether they have been identified as a
qualified bilingual/multilingual staff member. OCR will consider
developing guidance and providing technical assistance for covered
entities on mechanisms for covered entities to assess if staff members
meet the requirements.
Consistent with the Department's approach on language access, OCR
encourages covered entities to provide training and compensation
opportunities to support professional development for bilingual/
multilingual staff.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``qualified
bilingual/multilingual staff'' as proposed in Sec. 92.4, with
modification. As discussed in the summary of regulatory changes to the
proposed term ``limited English proficient individual,'' we are
revising the term to ``individual with limited English proficiency'' in
Sec. 92.4.
Qualified interpreter for an individual with a disability. We
proposed to define the term ``qualified interpreter for an individual
with a disability'' to mean ``an interpreter who . . . is able to
interpret effectively, accurately, and impartially, both receptively
and expressively, using any necessary specialized vocabulary.'' Such an
interpreter may interpret via a video remote interpreting service (VRI)
or in person. We also provided a non-exhaustive list of examples of
qualified interpreters, to include sign language interpreters, oral
transliterators, and cued-language transliterators.
Comment: Most of the commenters recommended that OCR amend this
definition to include the three (3) parts of the definition of
``qualified interpreter for an individual with limited English
proficiency'', which requires that the qualified interpreter: (1) has
demonstrated proficiency, (2) is able to interpret effectively,
accurately, and impartially, (3) and adheres to generally accepted
interpreter ethics principles. Commenters noted that these revisions
would provide alignment between the different types of interpreters and
recognize that similar standards should apply regardless of whether an
interpreter is interpreting for an individual with LEP or a person with
a disability.
Commenters recommended that the definition include that a qualified
interpreter for a person with a disability demonstrate proficiency. For
sign language interpreters, this should include proficiency in speaking
or communicating in and understanding both English and a relevant sign
language, noting that not all individuals who are deaf or hard of
hearing are signers of American Sign Language (ASL). Some commenters
also recommended that in order to be proficient, Certified Deaf
Interpreters (CDI) must have specialized training in Deaf interpreting
in addition to the basic CDI training. For transliterators, these
commenters recommended that the rule require proficiency in the
relevant alternative communication modality, such as cued speech or
oral transliteration.
Commenters further stated that an interpreter for an individual
with a disability should communicate ``without changes, omissions, or
additions while preserving the tone, sentiment, and emotional level of
the original statement.''
Finally, commenters stated that an interpreter for an individual
with a disability must also adhere to the principles contained in
recognized standards of practice and professional codes of ethics for
health care interpreters, such as those of the National Council on
Interpreting in Health Care and the Registry of Interpreters for the
Deaf.
Response: We appreciate commenters' recommendation to revise the
definition
[[Page 37546]]
of ``qualified interpreter for an individual with a disability'' to
align more closely with the definition of ``qualified interpreter for
an individual with limited English proficiency''. While the proposed
definition is consistent with the ADA, we agree that the standards for
a qualified interpreter should be equivalent regardless of whether an
individual has LEP or has a disability. We have revised the definition
for consistency among the standards, which is also consistent with the
2016 Rule's definition at former 45 CFR 92.4.
Comment: Some commenters recommended aligning the two qualified
interpreter definitions but recommended that a revised definition be
expanded to recognize qualified interpreters who have demonstrated
proficiency in speaking and understanding two non-English languages.
These commenters noted that not all interpreters for people with
disabilities are interpreting between English and another language. For
example, these commenters noted that a CDI may be interpreting between
an individual who is deaf and uses a unique version of ASL and a non-
American sign language, or home signs unfamiliar to the medical
interpreter. Commenters were concerned that a definition that specified
interpretation ``between English and non-English language'' would
exclude CDIs and cued-language transliterators. These commenters
recommended a multi-pronged definition where several contexts are taken
into consideration and is inclusive of ASL-to-English interpretation,
ASL-to-ASL CDI interpretation, and cued-language transliteration.
Response: As proposed, the definition of ``qualified interpreter
for an individual with a disability'' does not reference ``English'' or
a ``non-English language,'' but rather included a non-exhaustive list
of examples of qualified interpreters inclusive of sign language
interpreters, oral transliterators, and cued-language transliterators.
However, as previously discussed, we have revised the definition of
``qualified interpreter for an individual with a disability'' to be
more aligned with the definition of ``qualified interpreter for an
individual with limited English proficiency.'' The revised definition
includes language that is inclusive of different types of
interpretation and also includes the non-exhaustive list of examples
from the proposed definition.
Comment: Some commenters noted that a covered entity must not use
the services of staff who use sign language or another communication
modality to act as interpreters and relay information to individuals
with disabilities unless they meet the definition of a ``qualified
interpreter for an individual with a disability'' found within this
section, and they meet the unique needs of the individual for whom the
services of an interpreter is being provided.
Response: The definition of a ``qualified interpreter for an
individual with a disability'' addresses these concerns; and anyone
designated by a covered entity to serve as an interpreter for an
individual with a disability must be qualified to do so.
Comment: Some commenters recommended that the definition of
``qualified interpreter for a person with a disability'' take into
consideration applicable State law governing licensure of interpreters
if any are available in the State where the covered entity provides
services. These commenters noted that the process of who can serve as a
qualified interpreter differs from State to State, and OCR should adopt
language that reflects the minimum standards of State laws governing
qualifications of sign language interpreters, if any.
Response: OCR understands and appreciates commenters raised
concerns. Covered entities may use adherence to State law governing
licensure as a means by which to demonstrate compliance with this
definition, provided licensure demonstrates the individual possesses
the requirements provided in the definition. OCR declines to adopt
language that incorporates any State law licensure requirements as a
minimum standard of compliance with this rule.
Comment: Some commenters raised concerns over the qualifications of
interpreters. Commenters recommended that the definition include the
requirement that an interpreter be certified or assessed by a formal
process that objectively measures the competency of the individual.
Other commenters recommended that health care entities include a
screening system to ensure quality assurance of the abilities of the
sign language interpreters to meet the needs of the patients.
Response: OCR appreciates the commenters' recommendations to
require certification for qualified interpreters and agrees that
covered entities should ensure that the use of interpreter services
provides for effective communication. OCR will take into account
certification in assessing compliance with this regulation; however, as
we will discuss below in the response for certification of qualified
interpreter for an individual with LEP in Sec. 92.201, we decline to
require certification in the definition of ``qualified interpreter for
an individual with a disability.''
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``qualified
interpreter for an individual with a disability'' in Sec. 92.4, to
more closely align with the definition of ``qualified interpreter for
an individual with limited English proficiency,'' such that it now
means an interpreter who, via a video remote interpreting service (VRI)
or an on-site appearance: (1) has demonstrated proficiency in
communicating in, and understanding: (i) both English and a non-English
language (including American Sign Language, other sign languages); or
(ii) another communication modality (such as cued-language
transliterators or oral transliteration); (2) is able to interpret
effectively, accurately, and impartially, both receptively and
expressively, using any necessary specialized vocabulary or terms
without changes, omissions, or additions and while preserving the tone,
sentiment, and emotional level of the original statement; and (3)
adheres to generally accepted interpreter ethics principles including
client confidentiality. Qualified interpreters include, for example,
sign language interpreters, oral transliterators, and cued-language
transliterators.
Qualified interpreter for a limited English proficient individual.
OCR proposed to define the term ``qualified interpreter for a limited
English proficient individual'' to mean 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. This definition is consistent with both the 2016 Rule
at former Sec. 92.4 and the 2020 Rule at Sec. 92.101(b)(3)(i).
Comment: Some commenters who otherwise supported this definition
expressed concern that, as written, it may inadvertently create
difficulties for interpreting in certain languages, especially
indigenous languages of Central and South America. These
[[Page 37547]]
commenters recommended that the definition be amended to allow for the
use of services of relay interpreters, such as those who are proficient
in an indigenous language and another language such as Spanish.
Commenters explained that these interpreters may not be fluent in
spoken English or trained to interpret to and from spoken English, and
that those who are qualified to interpret between two non-English
languages are critical in providing meaningful access for many isolated
and marginalized communities. Furthermore, a few of these commenters
recommended the inclusion of the following definition for relay
interpreting: ``relay interpreting means a form of simultaneous
interpreting when the speech is rendered from an intermediate language
rather than directly from the source language.''
One commenter recommended adding ``and dialect'' after ``spoken
language'' under paragraph (1) to acknowledge that speakers of a
language may not always be qualified to interpret for a person who
speaks a variation in that language and adding ``understanding and''
before ``using necessary specialized vocabulary or terms'' under
paragraph (2) to indicate that providing effective interpretation for
complex situations, such as communicating a treatment regimen, requires
understanding of the terminology being used, particularly given the
consequences of a miscommunication.
Response: OCR appreciates and understands concerns that the
proposed definition may inadvertently create obstacles for meaningful
access in certain languages. For example, if a Zapotec-speaking patient
with LEP attended a medical appointment and the hospital could not find
an individual qualified to interpret between Zapotec and English after
reasonable efforts, the hospital could utilize the services of two
qualified interpreters that could perform relay interpretation between
Zapotec and Spanish and Spanish and English. While relay interpretation
may introduce challenges related to accuracy, it may be necessary to
afford meaningful access for individuals who speak languages, dialects,
or variants not common to the area where they are receiving services.
For this reason, we are revising the definition of a ``qualified
interpreter for an individual with limited English proficiency'' to
provide that the qualified interpreter (1) has demonstrated proficiency
in speaking and understanding both spoken English and at least one
other spoken language (qualified interpreters for relay interpretation
must demonstrate proficiency in two non-English spoken languages); and
(2) is able to interpret effectively, accurately, and impartially to
and from such language(s) and English (or between two non-English
languages for relay interpretation), 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. This provision makes clear that specialized skills and
vocabulary may be needed for less commonly spoken languages as well as
dialects.
In light of these modifications to the definition of ``qualified
interpreter for an individual with limited English proficiency'', we
are also adding and finalizing a definition of ``relay interpretation''
to mean interpreting from one language to another through an
intermediate language. This mode of interpretation is often used for
monolingual speakers of languages of limited diffusion, including
select indigenous languages. In relay interpreting, the first
interpreter listens to the speaker and renders the message into the
intermediate language. The second interpreter receives the message in
the intermediate language and interprets it into a third language for
the speaker who speaks neither the first nor the second language.
Lastly, OCR appreciates the commenter's suggestion to add
``understanding and'' before ``using necessary specialized vocabulary
or terms'' under paragraph (2). However, the interpreter themself does
not need to understand complex medical concepts behind medical terms
but rather must be able to interpret said terms effectively and
accurately. OCR is of the view that the interpretation should directly
convey the provider and patient's words and phrases in order to avoid
the risk that the individual's message was not accurately communicated.
Further, paragraph (1) already requires that the interpreter have
``proficiency in speaking and understanding'' the languages at issue
(emphasis added).
Comment: A few commenters recommended the definition address how an
individual would demonstrate proficiency in English and another
language (i.e., through use of an established standard for describing
language ability, such as the Common European Framework of Reference of
Languages \61\). Some commenters recommended implementing a
certification requirement and suggested implementing a national
credential requirement that establishes interpretation proficiency for
enforcement purposes. Some commenters requested that OCR lay out
examples of when it would be appropriate to require qualified
interpreters to obtain certification in order to comply with section
1557. Commenters expressed their belief that the proposed definition
could be easily misinterpreted and result in assigning the least
skilled interpreter for a medical encounter.
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\61\ Council of Europe, Common European Framework of Reference
for Languages (CEFR), https://www.coe.int/en/web/common-european-framework-reference-languages/introduction-and-context.
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Response: OCR appreciates the commenters' suggestions to establish
certification requirements for qualified interpreters; however, there
are currently no consistent certification standards and there is also a
lack of certification available for a significant number of languages.
The requirements in this definition provide sufficient standards for
determining interpreter qualifications. Individuals that hold a
certification will still need to meet the standards provided in this
definition. For covered entities seeking information on certification,
we encourage covered entities to review the Department of Justice's
(DOJ) resource regarding what it means to be a certified linguist.\62\
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\62\ U.S. Dep't of Justice, Fed. Coordination & Compliance
Section, What Does It Mean to Be a Certified Linguist (2014),
https://www.justice.gov/crt/page/file/1255916/download.
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Comment: One commenter encouraged OCR to include ``via a video
remote interpreting service'' to the definition because telehealth can
be an important tool for expanding access to interpretation for
individuals with LEP.
Response: The definition as proposed and finalized includes
interpreter services provided via remote interpreting services and is
therefore inclusive of video remote interpreting as drafted.
Comment: One commenter noted that we use the phrase ``use an
interpreter'' in our text. They recommended we use the wording
``utilize the services of an interpreter'' instead.
Response: OCR agrees that we are referring to the utilization of
interpreter services and have adjusted the use of this phrase
accordingly.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments we received, we are revising the definition for a ``qualified
interpreter for an individual with limited English proficiency'' as
proposed in Sec. 92.4, with modifications. To account for concerns
related to relay
[[Page 37548]]
interpreting, we are revising paragraph (1) to add ``(qualified
interpreters for relay interpretation must demonstrate proficiency in
two non-English spoken languages).'' As discussed in the summary of
regulatory changes to the proposed term ``limited English proficient
individual'' we are revising the term to ``individual with limited
English proficiency'' in Sec. 92.4. We are also adding a definition of
``relay interpretation'' to Sec. 92.4 to mean interpreting from one
language to another through an intermediate language. This mode of
interpretation is often used for monolingual speakers of languages of
limited diffusion, including select indigenous languages. In relay
interpreting, the first interpreter listens to the speaker and renders
the message into the intermediate language. The second interpreter
receives the message in the intermediate language and interprets it
into a third language for the speaker who speaks neither the first nor
the second language.
Qualified Reader. We proposed to define the term ``qualified
reader'' to mean ``a person who is able to read effectively,
accurately, and impartially using any necessary specialized
vocabulary,'' which comes from the ADA title II regulation at 28 CFR
35.160 through 35.164. This definition, which did not appear in the
2016 or 2020 Rules, was included to provide clarity to both covered
entities and protected individuals about the necessary qualifications
of a reader when required under this regulation.
Comment: Commenters supported the addition of ``qualified reader''
to the proposed list of definitions.
Response: OCR appreciates the commenters support for adding the
definition of ``qualified reader'' to the proposed list of definitions.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments we received, we are finalizing the definition of ``qualified
reader'' as proposed in Sec. 92.4, without modification.
Qualified Translator. OCR proposed to define the term ``qualified
translator'' to mean 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. This definition of ``qualified
translator'' appeared in the 2016 Rule at Sec. 92.4 and appears in the
2020 Rule at Sec. 92.102(b)(2)(ii) and has not been changed.
Comment: One commenter recommended that the definition of a
``qualified translator'' include the requirement that such individuals,
for purposes of providing translation services, be certified or
assessed by a formal process that objectively measures the competency
of the individual. A number of commenters stated that high quality
translation is essential to providing equal access to health care and
health services. Some added that oral interpretation is critical to
ensuring understanding of written translations, some of which have been
inaccurate or insufficient to convey the complicated medical and
technical terms translated in the communications.
Response: OCR appreciates the commenter's suggestion to require
that a qualified translator be certified or objectively assessed to
verify competency in translating. For the reasons we provided when
declining to require certification of qualified interpreters for
individuals with LEP, we decline to specify the means by which a
covered entity may determine that an individual meets the definition of
``qualified translator''. In order to be qualified, translators must
meet the definition provided in the rule. OCR also notes that
reasonable steps to provide meaningful access may require the provision
of both written translation and oral interpreting, and thus utilizing
the services of both a qualified translator and a qualified interpreter
may be necessary under certain circumstances.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the definition of ``qualified
translator'' as proposed in Sec. 92.4, without modification.
State. The 2022 NPRM did not propose a definition of the term
``State.'' However, based on comments received, we became aware that
there may be some confusion as to what encompasses ``State'' for
purposes of this final rule. We therefore have decided to include a
definition of ``State.''
Summary of Regulatory Changes
Considering the comments received, we are finalizing a definition
of ``State'' in Sec. 92.4 to mean ``each of the several States, the
District of Columbia, the Commonwealth of Puerto Rico, Guam, American
Samoa, the Virgin Islands, the Trust Territory of the Pacific Islands,
and the Commonwealth of the Northern Mariana Islands.'' This definition
is consistent with the ADA regulations at 28 CFR 35.104.
Telehealth. The 2022 NPRM did not propose a definition of the term
``telehealth.'' However, based on comments received, we became aware
that there may be some confusion as to what encompasses ``telehealth''
for purposes of this final rule. We therefore have decided to include a
definition of ``telehealth.''
Summary of Regulatory Changes
Considering the comments received, we are finalizing a definition
of ``telehealth'' in Sec. 92.4 to mean 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. Technologies
include videoconferencing, the internet, store-and-forward imaging,
streaming media, and terrestrial and wireless communications. This
definition is consistent with the Health Resources and Services
Administration and the Office of the National Coordinator for Health
Information Technology definitions referenced in the 2022 NPRM, 87 FR
47884.
Assurances Required (Sec. 92.5)
In Sec. 92.5 of the 2022 NPRM, we proposed retaining the
requirement of the 2016 and 2020 Rules, at former Sec. 92.5 and
current Sec. 92.4 respectively, for recipients to submit assurances of
compliance to OCR. In paragraph (a), we proposed that each entity
applying for Federal financial assistance, each issuer seeking
certification to participate in an 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 and this part, consistent with similar requirements
found in the implementing regulations for 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.
The comments and our responses regarding Sec. 92.5 are set forth
below.
Comment: Commenters expressed support for the assurances provision
included in the 2022 NPRM because it
[[Page 37549]]
is consistent with other Federal civil rights regulations and the 2016
and 2020 Rules, and it is reasonable for OCR to require recipients of
Federal financial assistance to comply with section 1557 as a condition
of receiving that funding. One organizational commenter recommended
revising this requirement to conditioning prospective recipients'
receipt of Department Federal financial assistance on recipients': (1)
collection of demographic data such as race, ethnicity, spoken and
written language, disability status, age, sex, gender identity, sex
characteristics, and sexual orientation; and (2) submission of a
written proposal (including through written policies and procedures)
about how they intend to provide language assistance services,
auxiliary aids and services, and whether an entity's proposed budget
includes funding to meet these identified needs.
Response: We appreciate the suggestion to include a data collection
requirement in this provision, but do not believe such a requirement is
appropriate, as this language is longstanding and consistent across
civil rights regulations. We address data collection in further detail
later in this preamble, when discussing responses to our request for
comment on the issue.
We also decline to revise Sec. 92.5 to require Federal financial
assistance applicants to provide OCR with budget information and a
written proposal about how they intend to provide language assistance
services and auxiliary aids and services as a condition of receiving
Federal financial assistance. The combined requirements at Sec. Sec.
92.8 (Policies and procedures), 92.201 (Meaningful access for
individuals with LEP), 92.202 (Effective communication for individuals
with disabilities), and 92.205 (Requirement to make reasonable
modifications) address the commenter's concerns regarding a recipient's
obligation and ability to provide language assistance services and
auxiliary aids and services.
Comment: One commenter raised concerns that proposed Sec. 92.5's
requirement that recipients make assurances to comply with all
provisions of the rule does not take into account situations where a
third party administrator could otherwise lawfully administer a plan
sponsored by a religious employer that does not conform to OCR's
current interpretation of section 1557 with regard to the prohibition
on sex discrimination. Specifically, the commenter suggested that a
third party administrator may be inhibited from submitting an assurance
required by Sec. 92.5 because (1) of the Employee Retirement Security
Act of 1974 (ERISA), 29 U.S.C. 1104(a)(1)(D), which for example,
obligates such a third party administrator to administer the religious
employer's self-insured health plan in accordance with terms that may
conflict with section 1557's prohibition of sex discrimination; and (2)
there are injunctions that currently prohibit OCR from enforcing
prohibitions on sex discrimination against religious employers and
those acting in concert with them.\63\
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\63\ Franciscan All., 553 F. Supp. 3d at 378.
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Response: OCR complies with court orders, including court-ordered
injunctions. If a recipient third party administrator is covered by any
current court order or court-ordered injunction, OCR would not find the
third party administrator to be in violation of section 1557 or this
rule for its activities that are covered by the injunction, and such an
entity would not need to provide an assurance under Sec. 92.5 to the
extent it conflicts with a current court order or court-ordered
injunction by which they are covered.
Regarding the commenter's point that third party administrators are
required under ERISA to administer plans consistent with the plan's
terms, OCR addresses this issue in detail under the third party
administrator section of Sec. 92.207. In short, while we acknowledge
that ERISA requires plans to be administered consistent with the
documents and instruments governing the plan,\64\ ERISA further
provides that it is not to be construed to impair or supersede other
Federal laws, including regulations issued under such laws.\65\ Courts
have held that ERISA's requirement to comply with the terms of the plan
must not be construed to invalidate or impair section 1557.\66\
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\64\ 29 U.S.C. 1104(a)(1)(D) (``[A] fiduciary shall discharge
his duties with respect to a plan solely in the interest of the
participants and beneficiaries and . . . in accordance with the
documents and instruments governing the plan insofar as such
documents and instruments are consistent with the provisions of this
subchapter and subchapter III.'').
\65\ 29 U.S.C. 1144(d) (``Nothing in this subchapter shall be
construed to alter, amend, modify, invalidate, impair, or supersede
any law of the United States (except as provided in sections 1031
and 1137(b) of this title) or any rule or regulation issued under
any such law.'').
\66\ See, e.g., C. P. by & through Pritchard v. Blue Cross Blue
Shield of Ill., No. 3:20-CV-06145-RJB, 2022 WL 17788148, at *8, 10
(W.D. Wash. Dec. 19, 2022) (holding that ERISA's requirement at 29
U.S.C. 1104(a)(1)(D) to administer a plan's terms as written ``is
subservient to Section 1557, outlawing discrimination, which is
dominant''); Tovar v. Essentia Health, 342 F. Supp. 3d 947, 954 (D.
Minn. 2018) (``The Court will not construe ERISA to impair Section
1557. Nothing in Section 1557, explicitly or implicitly, suggests
that TPAs are exempt from the statute's nondiscrimination
requirements.'').
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.5, without modification.
Remedial Action and Voluntary Action (Sec. 92.6)
In Sec. 92.6, OCR proposed to include requirements regarding
remedial and voluntary action, which would reinstate former Sec. 92.6
in the 2016 Rule and is consistent with parallel requirements in the
implementing regulations for section 504, title IX, and the Age Act.
The 2020 Rule does not include a similar provision. In Sec. 92.6(a)(1)
of the 2022 NPRM, we proposed requiring recipients or State Exchanges
that have been found by the Director to have engaged in discriminatory
conduct in their health programs and activities in violation of this
part to take voluntary actions to remediate the effects of such
discriminatory conduct. Similarly, we proposed that under Sec.
92.6(a)(2), where a recipient exercises control over another recipient
that has discriminated, the Director may require either or both
entities to take remedial action. Under proposed Sec. 92.6(a)(3), a
recipient or State Exchange must take remedial action if OCR requires
such action to redress the harm experienced by an individual who was
subjected to prohibited discrimination. Under proposed Sec. 92.6(b), a
covered entity may voluntarily take nondiscriminatory steps to overcome
the effects of the conditions that limited an individual's ability to
participate in a health program or activity based on their race, color,
national origin, sex, age, or disability.
The comments and our responses regarding Sec. 92.6 are set forth
below.
Comment: Commenters generally supported the requirement that a
recipient remedy instances of confirmed discrimination and the
voluntary action provision that allows for covered entities to address
effects of past discrimination.
One commenter recommended that we limit the application of this
provision to avoid exposing recipients to unfair and specious claims of
discrimination. Specifically, the commenter suggested that the remedial
action be limited to: (1) individuals who applied to participate in a
health program or activity but were unable to participate due to
alleged discrimination; or (2) individuals who had been participants in
a health program or activity but are no longer participants due to
alleged discrimination.
[[Page 37550]]
Response: This provision is an essential tool in remediating
findings of discrimination and encouraging recipients to take voluntary
actions to overcome potential discrimination. The suggested revisions
to Sec. 92.6 are unnecessary, as they generally request implementing
conditions that are already present. For example, Sec. 92.6(a)(1)
requires remedial action by a recipient or State Exchange only after a
finding of discrimination. Section 92.6(a)(3) limits any required
remedial action in the spirit of the commenter's recommendation, namely
providing that recipients and State Exchanges take remedial action with
respect to individuals who were or would have been participants in the
health program or activity had the discrimination not occurred.
Covered entities are prohibited from discriminating and as such
should take steps to ensure nondiscrimination, even in the absence of a
finding of discrimination by OCR. Where a covered entity has identified
conditions that currently or in the past had resulted in limited
participation in their health programs and activities by individuals
protected by this rule, they are encouraged to take the voluntary
action contemplated in Sec. 92.6(b).
We also note that regulations for section 504, title IX, and the
Age Act require recipients to take remedial action, and recipients have
complied with the remedial action provisions in those civil rights
statutes for more than 40 years.\67\ For example, where there is a
finding that a recipient engaged in disability discrimination, the
recipient's remedial action to overcome the effects of the disability
discrimination would likely satisfy this provision's remedial action
requirement as well as section 504's remedial action requirement at 45
CFR 84.6(a).
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\67\ See 45 CFR 84.6(a) and (b) (section 504); 86.3(a) and (b)
(title IX); and 91.48 (Age Act).
---------------------------------------------------------------------------
Comment: Another commenter expressed concern about the obligation
this provision places on a recipient that exercises control over
another recipient that is found to have engaged in discrimination
prohibited by section 1557. The commenter recommended that OCR revise
the provision so that only the recipient that OCR found to have engaged
in unlawful discrimination (and not the controlling entity) take
remedial action and that OCR enumerate specific remedial actions OCR
may require and the circumstances under which OCR may require them.
Response: The word ``control'' has appeared in civil rights
regulations enforced by OCR for many years, and its meaning has been
established over time. As we explained in the preamble for the 2016
Rule, OCR's experience and the longstanding approach for controlling
entities to secure appropriate action from discriminating entities over
which they have control has played an important role in remedying
discrimination. 81 FR 31393. Given that nothing has changed in OCR's
experience in the intervening years regarding the principles of
``control'' as applied here, we decline to define the term ``control.''
While we appreciate the commenter's request to list the remedial
actions OCR may require of a recipient or State Exchange found in
violation of this part, the remedial actions that a recipient or State
Exchange must take to address confirmed discrimination will be subject
to the facts involved in a particular case. A review of past resolution
agreements provides useful, though not exhaustive, examples of the
variety of means by which OCR achieves corrective action.\68\
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\68\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Recent Civil Rights Resolution Agreements & Compliance Reviews,
https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/agreements/index.html.
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Comment: One commenter recommended that OCR revise Sec. 92.6 to
require a recipient or State Exchange to notify participants,
enrollees, and beneficiaries of any finding of discrimination by the
Director and the remedial action the recipient has taken or will take
to address the confirmed discrimination.
Response: We recognize the benefit that notice of confirmed
discrimination and the steps a recipient or State Exchange will take to
remedy the discrimination can provide to participants, enrollees, and
beneficiaries. While we encourage recipients and State Exchanges to
provide notice to participants, we decline to require they do so.
Current Federal civil rights regulations with similar remedial and
voluntary action provisions do not include a notice requirement, and we
do not believe imposing such a requirement on recipients and State
Exchanges is warranted at this time. We note, however, it is OCR's
practice to notify the public via a press release or posting on our
website when a violation has been found or a resolution has been
reached.\69\ Additionally, OCR has established a Civil Rights listserv
to inform the public about civil rights settlement and enforcement
activities, press releases, FAQs, guidance, and technical assistance
materials. To subscribe to OCR's Civil Rights listserv, please visit
https://list.nih.gov/cgi-bin/wa.exe?SUBED1=OCR-CIVILRIGHTS-LIST&A=1.
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\69\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Civil Rights News Releases & Bulletins, https://www.hhs.gov/civil-rights/newsroom/index.html.
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Comment: One commenter recommended that, for Sec. 92.6(b)
(voluntary action), we replace ``may'' with ``must'' to require covered
entities to take nondiscriminatory steps to overcome effects that
result or resulted in limiting participants ability to participate in
the covered entity's health program or activities based on the
participants' race, color, national origin, sex, age, or disability.
Response: Such a revision would alter the voluntary nature of the
provision, which encourages covered entities to take nondiscriminatory
steps on their own accord to make their programs more inclusive absent
a finding of discrimination. We note that, when there is a finding that
prohibited discrimination occurred, Sec. 92.6(a) mandates the
offending recipient or State Exchange to take action to remedy such
discrimination.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.6, without modification.
Designation and Responsibilities of a Section 1557 Coordinator (Sec.
92.7)
In proposed Sec. 92.7(a), OCR proposed requiring covered entities
with 15 or more employees to designate at least one employee to serve
as a Section 1557 Coordinator (``Coordinator'') to coordinate their
efforts to comply with and carry out the covered entity's
responsibilities under section 1557 and the part. OCR also proposed to
permit covered entities to, as appropriate, assign one or more
designees to carry out some of the responsibilities of the Coordinator.
In Sec. 92.7(b), we proposed a list of responsibilities of the
Coordinator. We invited comment on this requirement, including whether
OCR should require covered entities with fewer than 15 employees to
designate a Coordinator and, if so, whether there should be a requisite
number of employees or whether all covered entities should be required
to designate a Coordinator. We further sought comment on whether the
enumeration of responsibilities of the Coordinator is beneficial and
sufficiently comprehensive. We also requested comment on how the
[[Page 37551]]
Department can support Coordinators, including through the provision of
training, so that they understand their duties, the protections
afforded by section 1557, and the rationales for both.
The comments and our responses regarding Sec. 92.7 are set forth
below.
Comment: Commenters on this provision overwhelmingly supported the
Coordinator requirement at Sec. 92.7. A number of supportive
commenters indicated that civil rights violations often occur due to
ignorance, neglect, and administrative indifference, and Coordinators
will equip providers with critical civil rights knowledge and the
ability to recognize and adequately care for patients at risk for poor
health outcomes. Other commenters similarly emphasized that the
Coordinator requirement will equip covered entities with an internal
resource dedicated to section 1557 implementation and compliance, and
that this is especially critical for small covered entities and covered
entities in rural communities. Commenters cited a number of other
reasons for their support of the Coordinator requirement, including
that having a Coordinator will help covered entities proactively
protect civil rights; will provide central points of contact for
language access; and will allow covered entities and OCR to better
identify patterns or practices of discrimination, which will aid
covered entities in delivering effective and efficient care.
One commenter expressed concern about the possibility that
Coordinators evolve and become ineffective by privileging the
institutions they serve rather than appropriately conducting thorough
investigations of grievances. Relatedly, another commenter recommended
that OCR revise Sec. 92.7 to require covered entities' Coordinators to
be independently minded or independent from the covered entity to
ensure impartiality and transparency and to require that Coordinators
be able to work independently.
Many of these commenters cited the COVID-19 Public Health Emergency
as a reason for their support of the Coordinator requirement.
Specifically, they stated that the health outcomes resulting from the
COVID-19 pandemic highlighted covered entities' ignorance of civil
rights regulations with respect to individuals from marginalized
communities.
Response: We agree with commenters regarding the myriad benefits of
the Coordinator requirement, particularly with regard to increasing
covered entities' ability to proactively prevent discrimination before
it happens and hopefully more thoroughly address it when it does.
Coordinators are expected to perform their impartially, which will also
benefit covered entities through ensuring compliance with section 1557.
OCR appreciates commenters' concerns that Coordinators be
sufficiently independent from a covered entity to ensure impartiality
and transparency. We note that a covered entity may run the risk of
noncompliance with section 1557 if an investigation reveals that its
Coordinator did not carry out their obligations under section 1557 in
an impartial manner. By having a Coordinator, with specific compliance
responsibilities, OCR expects that covered entities will be cognizant
of the importance of compliance with civil rights requirements,
including in times of public health emergencies or other crises.
Comment: Other commenters opposed the Coordinator requirement,
contending that it will increase the burdens covered entities will
face.
One commenter reiterated the 2020 Rule's reasoning for eliminating
the Coordinator requirement by stating that regulations for underlying
civil rights statutes requiring coordinators is sufficient for section
1557 enforcement. Another commenter stated covered entities can meet
section 1557 compliance obligations without a Coordinator. Yet another
commenter recommended that OCR instead encourage practices to adopt a
collaborative approach where all staff take an active role in ensuring
nondiscrimination.
Response: The role of the Coordinator is to promote effective and
efficient implementation of section 1557 and the part, and in so doing
decrease compliance inefficiencies and promote meaningful
investigations of allegations of potential civil rights violations.
OCR remains confident that the benefits to a covered entity and the
public of the Coordinator requirement outweigh any potential burdens.
Time spent coordinating a covered entity's section 1557 compliance
program is an investment that will likely result in improved,
nondiscriminatory health care delivery and saving resources otherwise
spent responding to potential OCR investigations and private
litigation. Even if a covered entity is subject to a civil rights
complaint or litigation, its Coordinator's presence and active
coordination efforts may enable the covered entity to more quickly
resolve a complaint or litigation.
This rule addresses the confusion that the 2020 Rule creates
surrounding the extent to which covered entities were required to
maintain a Coordinator for purposes of section 1557 compliance. The
2020 Rule does not clarify, for example, whether a covered entity's
existing section 504 coordinator--whose role relates to ensuring a
recipient's efforts to comply section 504 alone, per 45 CFR 84.7--must
also ensure the covered entity's compliance with section 1557's
prohibition of discrimination based on race, color, national origin,
age, or sex. OCR is providing for a specific Section 1557 Coordinator,
rather than relying on the requirements found in the implementing
regulations for the referenced statutes, to resolve any confusion as to
covered entities' responsibilities.
Comment: Some commenters requested that OCR clarify that
Coordinators are responsible for covered entities' internal section
1557 oversight and that covered entities may have other staff members
implement various Coordinator activities. These commenters recommended
that OCR revise Sec. 92.7(b) to add ``or designee'' after ``Section
1557 Coordinator'' to confirm that one or more staff can assist the
Coordinator with the enumerated Coordinator responsibilities. Some
commenters requested clarity about whether a covered entity's
Coordinator can also serve in other capacities within the covered
entity's organization, and whether the Coordinator requirement
obligates covered entities to hire a new employee to serve as a
Coordinator, and if so, whether the job description must list all of
the Coordinator responsibilities enumerated at Sec. 92.7(b).
Response: Section 92.7(a) expressly states that a covered entity
may assign one or more designees to assist the Coordinator in carrying
out their responsibilities. However, the Coordinator must retain
ultimate oversight for ensuring the covered entity's compliance with
this part. In general, it is the covered entity's prerogative to
designate any qualified individual to serve as its Coordinator. A
covered entity does not need to hire a new employee for the role, and
the Coordinator may serve in other capacities and have responsibilities
in addition to their Coordinator responsibilities at Sec. 92.7(b); so
long as those responsibilities do not create a conflict of interest or
otherwise prevent the Coordinator from effectively carrying out their
responsibilities.
Comment: Some commenters recommended that OCR not require covered
entities to list a Coordinator's name and contact information in their
publicly available Notice of Nondiscrimination because of the constant
need to update Coordinators'
[[Page 37552]]
names and contact information due to turnover and to avoid potential
harassment from section 1557 opponents. Instead, these commenters
requested that OCR allow covered entities to list the Section 1557
Coordinator job title instead of an individual's name.
Response: OCR appreciates the challenges associated with updating
specific contact information; for this reason, nothing in Sec. 92.8
(Policies and procedures) or Sec. 92.10 (Notice of nondiscrimination)
require covered entities to include a Coordinator's name. As proposed,
and finalized, Sec. Sec. 92.8(b) and 92.10(a)(1)(v) both require
``contact information'' for the Coordinator; providing the job title
rather than an individual's name is sufficient to meet this
requirement. However, contact information in the form of a phone
number, email address, and mailing address must also be provided. A
covered entity may establish a general phone number, email address,
and/or mailing address to meet this requirement. Absent this
information, individuals who need to reach the Coordinator will have no
knowledge of how to do so.
While this rule does not apply to employment practices, as
discussed in Sec. 92.2(b), employees of covered entities remain
protected against retaliation as provided in Sec. Sec. 92.303 and
92.304. If a covered entity's staff is harassing the Coordinator
because of the Coordinator's job responsibilities, the covered entity
should take appropriate measures to address the harassment, and, if the
harassment is based on one or more characteristics protected by the
Federal laws enforced by the EEOC, the Coordinator may file a charge of
discrimination with the EEOC at https://www.eeoc.gov/filing-charge-discrimination.\70\ If staff, including a covered entity's Coordinator,
are being threatened by other covered entity staff or by individuals
external to the covered entity, we strongly encourage reporting these
threats to the FBI at 1-800-225-5324 or via www.fbi.gov/tips.
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\70\ The EEOC is responsible for enforcing Federal laws that
make it illegal to discriminate against an employee because of the
person's race, color, religion, sex (including pregnancy, childbirth
or related medical conditions, gender identity, and sexual
orientation), national origin, age (40 or older), disability or
genetic information. See U.S. Equal Emp. Opportunity Comm'n,
Overview, https://www.eeoc.gov/overview.
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Comment: One commenter requested that OCR clarify whether a large
health system made up of several covered entities can have a single
Coordinator for the entire health system or whether each covered entity
needs to have its own Coordinator. Another commenter stated that it is
impossible for one Coordinator to oversee section 1557 compliance for
an entire large health care system, with another suggesting that there
should be at least one Coordinator for every 250 employees for covered
entities with 500 or more employees.
Response: In order to provide covered entities with flexibility,
OCR clarifies that large health systems may customize their Coordinator
and designee configurations as long as each individual covered entity
has either a Coordinator or designee responsible for section 1557
compliance. Because a covered entity is better positioned to determine
how to ensure that the coordinator(s) can effectively perform all of
their duties, we decline to revise the Coordinator requirement so that
a covered entity is required to designate one Coordinator for every 250
employees.
Comment: A significant number of commenters recommended that all
covered entities, regardless of size, have a Coordinator because
ensuring section 1557 compliance is integral to providing
nondiscriminatory health care services. Another commenter noted that
the requirement aligns with the Joint Commission's recent standards
requiring accredited hospitals and similar facilities to designate an
individual to lead activities to reduce health disparities.
Several commenters stated that the 15-employee threshold is
arbitrary, arcane, and inconsistent with protecting civil rights to the
maximum extent possible. Others stated the position is critical for
smaller covered entities that provide services to individuals with
disabilities, particularly in rural and low-income communities, and for
covered entities that provide long-term services and supports to older
adults and people with disabilities who use home and community-based
services. Others referenced that smaller covered entities include
mental health providers, social workers, psychologists, counselors, and
family and marriage therapists.
One commenter suggested that covered entities with fewer than 15
employees could still voluntarily designate a Coordinator.
Response: OCR appreciates comments received regarding the
application of the Coordinator provision. While all covered entities,
regardless of size, would benefit from having a dedicated Coordinator
on staff, we decline to extend the requirement to all covered entities
beyond those with 15 or more employees, in an effort to reduce
unnecessary or counterproductive administrative obligations on small
providers. OCR does not find this limitation to be arbitrary, as it is
consistent with section 504's coordinator requirement, 45 CFR 84.7(a),
and was also included in the 2016 Rule at former Sec. 92.7. We note
that covered entities with fewer than 15 employees retain the option of
designating a Coordinator.
Comment: Other commenters thought the 15-employee threshold was
appropriate, and that applying the requirement to smaller entities
would result in burdens and costs for small and solo practices. Another
commenter recommended increasing the employee threshold so that only
covered entities with 50 or more employees be required to designate a
Coordinator. Another commenter recommended that covered entities that
fall within the Small Business Association's (SBA) classification \71\
of a small business not be required to designate a Coordinator. Another
commenter recommended that the Coordinator requirement be removed
altogether.
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\71\ U.S. Small Business Ass'n, Basic Requirements: Meet Size
Standards, https://www.sba.gov/federal-contracting/contracting-guide/basic-requirements#section-header-6 (The SBA assigns a size
standard to each NAICS code. Most manufacturing companies with 500
employees or fewer, and most non-manufacturing businesses with
average annual receipts under $7.5 million, will qualify as a small
business.).
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Response: The Coordinator requirement is a vital step in
encouraging proactive civil rights compliance; therefore, OCR declines
to remove this provision. We also decline to increase the employee
threshold for the Coordinator requirement to 50 or more employees.
Though the coordinator requirement in title II of the ADA is limited to
public entities with 50 or more employees, 28 CFR 35.107, the 15-
employee threshold in section 504 is more appropriate for section 1557.
Section 504 covered entities are more analogous to section 1557 covered
entities given that they are recipients of Federal financial assistance
of all sizes; ADA title II covered entities, however, are all State or
local governments. For similar reasons, we believe that that the SBA
classification of a small business--which was set in a very different
context serving very different purposes--is inappropriate for this
rule.
Comment: Some commenters requested additional clarity about the 15-
employee threshold. For example, commenters asked whether part-time,
contractor, and sub-contractor employees would count toward a covered
entity's employee total or if
[[Page 37553]]
only full-time employees would count. One commenter suggested that,
without this clarification, some covered entities will engage in hiring
and human resources practices that undermine and abuse the 15-employee
threshold. Another commenter also sought to clarify whether only
clinical staff should count toward the 15-employee threshold and
whether administrative staff should count as well.
Response: With respect to the employees who will count towards the
15 or more-employee threshold, OCR will consider the total number of
individuals employed by a covered entity. This includes full-time and
part-time employees and independent contractors. All employees,
regardless of job classification (e.g., clinical versus clerical), will
count toward the threshold. We intend for this clarification to reduce
concerns that the 15-employee threshold may lead to questionable
employment practices.
Comment: One commenter indicated that the Coordinator requirement
implicates religiously affiliated covered entities' authority to hire
people who share their religious beliefs because requiring religiously
affiliated covered entities to have a Coordinator may compromise the
religiously affiliated covered entity's religious beliefs if its
Coordinator has fundamentally different beliefs or viewpoints.
Response: Nothing in the regulatory text requires a covered entity
to designate a Coordinator with a particular viewpoint or particular
beliefs. No part of this final rule prevents a religiously affiliated
recipient from designating or hiring an employee who shares the
entity's religious beliefs as its Coordinator, provided that the
individual is qualified to effectively and impartially perform the role
required by the regulation. In addition, where title VII applies to a
recipient's employment and hiring decisions, section 1557 does not
interfere or otherwise conflict with requirements or protections
afforded under title VII.
Comment: Several commenters supported the 2022 NPRM's inclusion of
an enumerated list of Coordinator responsibilities at Sec. 92.7(b).
Many of these commenters appreciate the flexibility for covered
entities to spread or delegate responsibilities to one or more
designees within a covered entity's organization. Some commenters
requested that OCR consider revising Sec. 92.7(b) to add an additional
responsibility that Coordinators coordinate with other covered
entities, as necessary, to ensure that individuals who are interacting
with multiple entities receive the required language assistance
services and/or auxiliary aids and services. A different commenter felt
that the enumerated list of Coordinator responsibilities at Sec.
92.7(b) is too prescriptive and recommended that OCR allow each covered
entity the opportunity to determine their Coordinator's
responsibilities.
Response: The responsibilities enumerated at Sec. 92.7(b) provide
a baseline for expected duties while allowing covered entities the
flexibility, discretion, and ability to structure responsibility for
such duties to their Coordinator(s) or designee(s). A covered entity
may assign duties beyond those enumerated at Sec. 92.7(b), at its
discretion.
With respect to situations where two covered entities are
interacting with the same individual with LEP, individual with a
disability, or individual with a disability with LEP, both covered
entities are responsible for ensuring that individuals receive the
appropriate language assistance services and/or auxiliary aids and
services required by this rule under Sec. Sec. 92.201 and 92.202. Some
agencies may find that coordination between their Section 1557
Coordinators will help to more effectively meet the needs of these
individuals, but OCR declines to implement a requirement to this effect
as each covered entity has an obligation under this part regardless of
what services they believe another covered entity may be providing.
Comment: Another commenter recommended that a covered entity's
Coordinator not handle section 1557 grievances given that a covered
entity may have an existing grievance collection point, which allows it
to quickly address grievances through existing structures. A different
commenter recommended that OCR clarify that a covered entity can assign
Coordinator responsibilities to a group or division instead of one or
more specific individuals because organizations may already have
individuals specifically trained and responsible for ensuring
nondiscrimination.
Response: These regulations do not prohibit a Coordinator from
working within existing organizational structures that receive and
investigate grievances or perform other Coordinator responsibilities
identified in Sec. 92.7(b). As discussed above, this provision
provides a covered entity wide latitude to designate one or more
Coordinator(s) and to assign one or more designee(s) to assist the
Coordinator with their responsibilities, including collecting and
addressing grievances. A covered entity may also assign Coordinator
responsibilities to a group or division, provided that the covered
entity identifies an individual Coordinator who retains ultimate
oversight for coordinating section 1557 compliance.
Comment: One commenter recommended that OCR make clear that, when
performing their grievance responsibilities, the Coordinator is
required to collect specific data, including: alleged basis or bases of
discrimination; the date the grievance was filed; the date of the
alleged discriminatory action; and the grievance resolution. This
commenter indicated that this data should not include individually
identifying information and indicated that the covered entity, through
the Coordinator, should be responsible for the privacy of the data that
they collect while fulfilling their coordinator role. A different
commenter recommended that OCR require Coordinators to review grievance
data in order to identify potential and actual discriminatory trends.
Response: OCR appreciates the commenter's suggestion regarding the
data that must be retained for each grievance. However, we decline to
include these details here as the data points the commenter suggested
are already in Sec. 92.8(c)(2), which discusses the information that
must be retained in grievance records. Although this final rule does
not require covered entities to collect data on trends across the
organization, we highly encourage all Coordinators to review grievance
data to identify and address any potential and actual discriminatory
trends revealed in such data. We discuss this in greater detail at
Sec. 92.8(c) (grievance procedure).
Comment: Multiple commenters requested that OCR provide training
and other resources to help covered entities implement the Coordinator
requirement. Some commenters requested that OCR provide (1) training
for people who are new to the Coordinator role and for providers who
are updating the role; (2) facts sheets to introduce section 1557 to
the Coordinator and other staff throughout the organization; and (3)
checklists that can be consulted and used to confirm the Coordinator's
responsibilities. One commenter requested that OCR training for
Coordinators include civil rights, cultural, and implicit bias
training.
Response: OCR commits to serve as a resource and partner with
covered entities that need help regarding their Coordinator
obligations. As discussed in further detail at Sec. 92.8 (Policies and
procedures), we plan to make various resources available to assist
Coordinators with their responsibilities.
Comment: One commenter asked how OCR will audit covered entities'
[[Page 37554]]
compliance with the Coordinator requirement and whether the Coordinator
post will be eligible for the Federal matching rate as an
administrative activity under section 1903(a)(7) of the Social Security
Act.
Response: Consistent with current practice, OCR will determine a
covered entity's compliance with the Coordinator requirement during
complaint investigations and affirmative compliance reviews. With
regard to the commenter's inquiry regarding the availability of Federal
financial participation under section 1903(a)(7) of the Social Security
Act, 42 U.S.C. 1396b(a)(7), OCR does not administer Medicaid and
therefore this comment is outside of the scope of this rulemaking.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.7, without modification.
Policies and Procedures (Sec. 92.8)
At Sec. 92.8 of the 2022 NPRM, OCR proposed requiring covered
entities to develop and implement written policies and procedures that
are designed to facilitate compliance with the requirements of the
part. We proposed requiring 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'').
In Sec. 92.8(a), we proposed a general requirement for 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 the part.
In Sec. 92.8(b), we proposed requiring 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: is prohibited from unlawfully discriminating 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 the part.
In Sec. 92.8(c), we proposed addressing 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
individuals with LEP and individuals with disabilities.
In Sec. 92.8(c)(1), we proposed requiring that covered entities
with 15 or more employees establish written civil rights grievance
procedures.
In Sec. 92.8(c)(2), we proposed 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 grievance.
In Sec. 92.8(c)(3), we proposed 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 invited 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 also sought comment on best practices for record retention
of grievance procedures, including strategies for ensuring patient
privacy.
In Sec. 92.8(d), we proposed requiring covered entities to develop
and implement written language access procedures to support compliance
with requirements to take reasonable steps to provide meaningful access
to individuals with LEP in their health programs and activities under
proposed Sec. 92.201.
In Sec. 92.8(e), we proposed requiring 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.
In Sec. 92.8(f), we proposed requiring 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.
In Sec. 92.8(g), we proposed 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 the part.
We sought comment on this proposed provision and whether there may
be alternative measures that OCR should consider to proactively prevent
discrimination, and whether they would be more or less burdensome than
what was proposed. We also invited comment from all covered entities
that had previously implemented or were currently implementing any of
the proposed procedures; consumers who interact with covered health
programs and activities; and community-based organizations that work
with individuals with LEP and individuals with disabilities. We also
requested comment on whether covered entities employing fewer than 15
people should be required to have a grievance procedure, including the
benefits of a less formal resolution process.
The comments and our responses regarding Sec. 92.8 are set forth
below.
General Comments
Comment: Many commenters expressed support for the Section 1557
Policies and Procedures requirement at Sec. 92.8, noting that, in
their view, it will help prevent discrimination and health disparities;
requires providers to proactively engage in the process of avoiding
discrimination; elevates covered entities and their employees'
knowledge about their section 1557 obligations; and alleviates the
burden on patients to file complaints in order to trigger section 1557
compliance and enforcement. Some commenters supported the requirement
because the 2020 Rule leaves requirements for policies and procedures
disjointed, confusing, and ineffective.
Some commenters recommended that OCR strengthen this requirement by
requiring covered entities to evaluate the effectiveness of their
Section 1557 Policies and Procedures and update them when necessary to
ensure consistency.
Response: Covered entities' Section 1557 Policies and Procedures
should be dynamic and updated to ensure covered entities comply with
changes in the law
[[Page 37555]]
and meet their section 1557 obligations. In addition, when covered
entities' operations change, this may necessitate revising Section 1557
Policies and Procedures to maintain section 1557 compliance.
Accordingly, we have added Sec. 92.8(h) to address when it is
required and permissible for a covered entity to revise their Section
1557 Policies and Procedures. Section 92.8(h)(1) explains that a
covered entity must review and revise its policies and procedures, as
necessary, to ensure they are current and in compliance with section
1557 and this rule. Section 92.8(h)(2) states that a covered entity may
change its policies and procedures at any time, provided that the
changed policies comply with section 1557 and the part.
Comment: Some commenters who opposed this requirement cited covered
entities' existing compliance burdens and the resources needed to draft
Section 1557 Policies and Procedures. Some commenters requested that,
if OCR maintains the requirement in the final rule, OCR make template
Section 1557 Policies and Procedures available for covered entities to
use and tailor to their organizations as far in advance of the final
rule's effective date as possible.
One commenter stated that existing Federal and State regulations
prevent covered entities from focusing on high-quality care, and that
this requirement is an unfunded mandate. One commenter recommended that
OCR should continue previously permitted flexibility and allow covered
entities to develop Section 1557 Policies and Procedures voluntarily.
Response: To assist covered entities' compliance with this
requirement, OCR has developed Section 1557 Policies and Procedures
templates that are available on OCR's website at www.hhs.gov/1557,
which are designed to assist covered entities in tailoring their own
Section 1557 Policies and Procedures. We reiterate the requirement that
a covered entity's Section 1557 Policies and Procedures must be
reasonably designed, take into account a covered entity's size,
complexity, and the type of health programs or activities provided. A
covered entity should view these templates as a starting point for
adopting and implementing Section 1557 Policies and Procedures that are
specific to their health programs and activities. The templates
provided may be insufficient for large covered entities given the range
in complexity and structure of those entities, and entities must ensure
that their Section 1557 Policies and Procedures reflect the appropriate
scope.
Comment: Some commenters recommended that OCR not require covered
entities to identify the names of their respective Coordinators in
their Section 1557 Policies and Procedures required by Sec. 92.8(b),
(d), (e), and (f) because high employee turnover may make coordinators'
names obsolete and require constant changes.
Response: OCR notes that nothing in Sec. 92.8 requires a covered
entity to identify the Coordinator by name; rather, Sec. 92.8(b), (d),
(e), and (f) require the Coordinator's current contact information. The
referenced provisions require sufficient information for an individual
who needs assistance in implementing the procedures to reach the
Coordinator. Thus, a covered entity could choose to list the position
title with a phone number, email address, and mailing address.
Comment: One commenter requested that OCR clarify, especially with
respect to large health systems (such as hospitals, clinics, home care
entities, and home medical equipment retail settings), the regulatory
language related to scalability.
Response: OCR recognizes that covered entities--including not only
recipients, but also the Department and title I entities--need
flexibility when developing and implementing their Section 1557
Policies and Procedures. A covered entity should consider its size,
capabilities, the costs of specific measures, the operational impact,
and the composition of the patient populations they serve in deciding
the appropriate scale of their Section 1557 Policies and Procedures.
Thus, OCR expects the scope and detail of a covered entity's Section
1557 Policies and Procedures to vary accordingly.
Comment: Some commenters requested that OCR include additional
required policies and procedures, such as policies and procedures
regarding service animals, protecting civil rights in public health
emergencies, assessing the competency of bilingual/multilingual staff,
and telehealth. Specifically, one commenter recommended requiring a
telehealth procedure designed to assist covered entity employees
communicate with patients before, during, and after telehealth visits,
and that this telehealth procedure could address pre-appointment
telehealth screenings to ensure that patients have the necessary
equipment or technology for their appointments and to determine whether
the patient has the requisite technological skills to participate in a
telehealth session. The proposed telehealth procedure would require
covered entities to provide telehealth training resources for patients
who lack skills or familiarity with telehealth prior to their
appointments. Other commenters recommended that covered entities'
procedures ensure accessibility for individuals with physical and/or
behavioral health disabilities and specifically comply with the U.S.
Access Board's Standards for Accessible Medical Diagnostic Equipment.
82 FR 2810 (Jan. 9, 2017).
Response: OCR recognizes the benefit of policies and procedures to
support civil rights compliance. However, we recognize that developing
and implementing such policies and procedures is not without an initial
burden on the covered entities, and the continued--though much
diminished--effort of maintaining the procedures and employee
familiarity with such procedures. For that reason, we decline to
require additional policies and procedures at this time. However,
covered entities are encouraged to develop and implement policies and
procedures related to service animals, protecting civil rights during
public health emergencies, assessing bilingual and multilingual staff
members' competency, nondiscriminatory provision of telehealth,\72\
accessible medical equipment, or any other situation they choose in
order to ensure compliance with section 1557. For more about section
1557's accessibility requirements, please refer to our discussion for
Sec. 92.204, which requires covered entities to make their buildings
and facilities accessible to individuals with disabilities. In
addition, please see the discussion of medical diagnostic equipment
under Sec. 92.207. Please also see the discussion of Sec. 92.211
related to nondiscrimination in the delivery of health programs and
activities through telehealth services.
---------------------------------------------------------------------------
\72\ See, e.g., U.S. Dep't of Health & Hum. Servs., Off. for
Civil Rts.; U.S. Dep't of Justice, Civil Rts. Div., Guidance on
Nondiscrimination in Telehealth: Federal Protections to Ensure
Accessibility to People with Disabilities and Limited English
Proficient Persons, https://www.hhs.gov/sites/default/files/guidance-on-nondiscrimination-in-telehealth.pdf.
---------------------------------------------------------------------------
Summary of UUegulatory changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the policies and procedures
requirement provision at Sec. 92.8 as proposed, with modifications. We
have added a paragraph (h) that explains that a covered entity must
review and revise its policies and procedures, as necessary, to ensure
they are current and in compliance with section 1557 and this rule and
that a covered entity
[[Page 37556]]
may change its policies and procedures at any time, provided that the
changed policies comply with section 1557 and this rule.
Nondiscrimination Policy
Comment: Many commenters supported the Nondiscrimination Policy at
proposed Sec. 92.8(b). Some commenters recommended that OCR revise the
language in this Policy so that the description of prohibited sex
discrimination is consistent with the description of sex discrimination
included in Sec. 92.101 (i.e., revise to include sex stereotypes and
pregnancy or related conditions). Some of these commenters further
recommended that OCR also specify that ``pregnancy or related
conditions'' includes termination of pregnancy. Other commenters
requested that OCR further revise Sec. 92.8(b)'s reference to sex
discrimination and make a corresponding revision to Sec. 92.101(a)(2)
by adding ``transgender status'' to the description of sex
discrimination for both provisions.
Response: OCR appreciates the need for consistency across the
regulation, and to ensure that the public is aware of the various types
of discrimination included under the umbrella of sex discrimination. We
clarify that a Nondiscrimination Policy's prohibition of sex
discrimination encompasses protections afforded for various types of
sex discrimination such as pregnancy, including termination of
pregnancy or related conditions, and we have revised the parenthetical
in Sec. 92.8(b) to explain that this provision's reference to sex
discrimination is consistent with the various types of sex
discrimination described at Sec. 92.101(a)(2), which includes ``gender
identity.'' We decline to add ``transgender status'' to the regulatory
text, as the term ``gender identity'' necessarily encompasses
``transgender status'' and these terms are often used
interchangeably.\73\
---------------------------------------------------------------------------
\73\ See, e.g., Bostock v. Clayton Cnty., Georgia, 590 U.S. 644,
658-59 (2020); Doe v. Mass. Dep't of Correction, No. CV 17-12255-
RGS, 2018 WL 2994403 (D. Mass. June 14, 2018); Whitaker v. Kenosha
Unified Sch. Dist. No. 1 Bd. of Educ., 858 F.3d 1034 (7th Cir.
2017).
---------------------------------------------------------------------------
At the same time, we want to emphasize that the ACA itself provides
that ``[n]othing in this Act shall be construed to have any effect on
Federal laws regarding--(i) conscience protection; (ii) willingness or
refusal to provide abortion; and (iii) discrimination on the basis of
the willingness or refusal to provide, pay for, cover, or refer for
abortion or to provide or participate in training to provide
abortion.'' 42 U.S.C. 18023(c)(2)(A). HHS will comply with this
provision.\74\ For further discussion regarding what constitutes sex
discrimination, including the application of religious freedom and
conscience protections in this context, please see the discussion at
Sec. 92.101(a)(2).
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\74\ The application of this final rule to covered entities with
religious freedom or conscience objections is discussed more fully
below in Sec. Sec. 92.3 (Relationship to other laws) and 92.302
(Notification of views regarding application of Federal religious
freedom and conscience laws).
---------------------------------------------------------------------------
Comment: One commenter expressed opposition to Sec. 92.8(b)
because it would increase paperwork without benefiting or improving the
quality of care.
Response: As we noted above, many commenters, some of which are
providers and professional medical associations, support the
requirement to have a Nondiscrimination Policy. Peer-reviewed medical
publications acknowledge that a health care organization's written
policies and procedures can improve quality of care and mitigate the
legal risk of causing patient harm.\75\ Indeed, research suggests that
the mere existence of policies that prohibit discrimination helps
reduce health and other inequities.\76\ Thus, we disagree with the
commenter's contention that Sec. 92.8(b) increases paperwork without
benefitting or improving quality of care particularly for individuals
who belong to communities with a history of experiencing discrimination
in health care settings.
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\75\ See James O'Donnell et al., Policies and Procedures:
Enhancing Pharmacy Practice and Limiting Risk, 37 Health Care & L.
341 (2012), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3411206/;
Savithiri Ratnapalan et al., Organizational Learning in Health Care
Organizations, 2 Systems 24-33 (2014), https://www.mdpi.com/2079-8954/2/1/24.
\76\ See generally Douglas Almond & Kenneth Chay, Civil Rights,
The War on Poverty, and Black-White Convergence in Infant Mortality
in the Rural South and Mississippi, Mass. Inst. of Tech., Dep't of
Economics, Working Paper Series, SSRN, (2007), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=961021; Doughlas Almond
& Kenneth Chay, The Long-Run and Intergenerational Impact of Poor
Infant Health: Evidence from Cohorts Born During the Civil Rights
Era, Nat'l Bureau of Econ. Rsch (2006), https://users.nber.org/
~almond/chay_npc_paper.pdf; Nancy Krieger et al., The Unique Impact
of Abolition of Jim Crow Laws on Reducing Inequities in Infant Death
Rates and Implications for Choice of Comparison Groups in Analyzing
Societal Determinants of Health, 103 a.m. J. of Pub. Health, 2234
(2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3828968/; John
J. Donahue III & James Heckman, Continuous Versus Episodic Change:
The Impact of Civil Rights Policy on the Economic Status of Blacks,
NBER Working Papers Series, SSRN, (2007), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=474003; David Card & Alan Krueger,
Trends in Relative Black-White Earnings Revisited, 83 The Am. Econ.
Rev. 85-91 (1993), https://www.jstor.org/stable/
2117645#:~:text=For%20both%20of%20these%20cohorts,1939%20cohort%20is%
20especially%20noteworthy.
---------------------------------------------------------------------------
Comment: A few commenters expressed First Amendment concerns
related to the overarching Section 1557 Policies and Procedures
requirement, particularly the Nondiscrimination Policy requirement. One
of these commenters recommended that, with respect to the Section 1557
Policy and Procedures requirement, OCR should clarify that covered
entities retain free speech protections to the extent that sex
discrimination does not result if a covered entity acknowledges a
patient's sex assigned at birth. An organizational commenter stated
that the Nondiscrimination Policy is problematic under the First
Amendment because requiring a covered entity to state that it does not
discriminate on the bases of pregnancy, sexual orientation, gender
identity, and sex characteristics constrains freedom of speech and
freedom of association.
Response: OCR acknowledges the comments regarding protections on
the basis of sex, particularly as they relate to nondiscrimination on
the basis of pregnancy or related conditions, sexual orientation, and
gender identity. As noted above, we have revised Sec. 92.8(b) by
removing descriptions of sex discrimination and by cross-referencing
Sec. 92.101(a)(2) and that provision's description of sex
discrimination. Thus, a covered entity's Nondiscrimination Policy need
not explicitly include the various forms of prohibited sex
discrimination to address any potential First Amendment concern.
However, we emphasize that these concerns do not negate a covered
entity's obligation to implement Section 1557 Policies and Procedures.
We also note here that we have amended the regulatory text to add,
as a best practice towards compliance, that a recipient's
Nondiscrimination Policy reflect assurance of exemptions that have been
triggered or that have been granted to that recipient under Sec.
92.302.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the Nondiscrimination Policy
requirement at Sec. 92.8(b) as proposed, with modifications. We are
revising Sec. 92.8(b)(1) to adjust the explanatory parenthetical for
sex in the Nondiscrimination Policy to state ``consistent with the
scope of sex discrimination described at Sec. 92.101(a)(2).'' We are
revising Sec. 92.8(b) to add paragraph (b)(2) that states, ``OCR
considers it a best practice toward achieving compliance for a covered
[[Page 37557]]
entity to provide information that it has been granted a temporary
exemption or granted an assurance of exemption under Sec. 92.302(b) in
the nondiscrimination policy required by paragraph (b)(1) of this
section.''
Grievance Procedures
Comment: In general, commenters supported the grievance procedures
requirement at Sec. 92.8(c), including because allowing patients to
voice concerns to providers builds trust between patients and
providers.
Response: OCR's enforcement experience reveals that grievance
procedures help covered entities lower compliance costs and provide
covered entities the opportunity to resolve grievances--through direct
communication with the individual raising the grievance--in the
quickest possible manner without OCR's involvement.
Comment: Some commenters recommended that OCR require covered
entities to adjudicate grievances quickly, and some of these commenters
specifically requested that OCR add timeframes by which section 1557
grievances must be both acknowledged and resolved because covered
entities may either belatedly or never acknowledge a complaint or take
longer than perceived as necessary to resolve grievances. Others
requested that OCR define ``prompt and equitable'' resolution, with one
stating that ``equitable'' is a subjective construct and suggested that
OCR consider requiring covered entities to resolve grievances by
affording the aggrieved individual appropriate access to the health
program or activity at issue. Relatedly, another commenter asked that
OCR consider differentiating between pretreatment grievances and other
grievances, because denials of care and coverage can result in the
postponement or foregoing of care altogether and can require patients
to wait for the resolution of a grievance before seeking care from an
alternate provider.
Response: We appreciate these commenters' desire for additional
specificity regarding what is meant by ``prompt and equitable''
resolution of a grievance. This terminology is consistent with
grievance procedures requirements found in the Department's section 504
and title IX regulations at 45 CFR 84.7(b) and 86.8(b), respectively.
Imposing a single timeframe by which a covered entity must resolve
a grievance does not account for the fact that covered entities vary in
size, resources, and capabilities, and so one timeframe may not be
appropriate for all entities. Multiple factors may impact the length of
time required to evaluate and resolve a particular grievance and to
ensure a fair process and reliable outcome, including the nature of the
grievance. This is balanced by the fact that prompt resolution of
complaints is necessary to further section 1557's nondiscrimination
objective. We encourage individuals to file complaints with OCR if they
have filed a grievance that they do not believe has been resolved in a
prompt and equitable manner. OCR's investigation of such a complaint
may determine whether a covered entity's grievances procedures truly
provide for prompt and equitable resolutions, and if they do not, OCR
may seek corrective actions from the covered entity. For these reasons,
we decline to add timeframes within which covered entities are required
to address grievances, and we decline to define the term ``prompt and
equitable.''
Comment: Some commenters recommended that OCR require covered
entities to notify individuals of the ability to file a grievance.
Other commenters requested that OCR revise Sec. 92.8(c) to require a
covered entity's process for filing grievances be simple, not
burdensome, and accessible to individuals with LEP and individuals with
disabilities.
Response: To the extent covered entities are required to have
grievance procedures, covered entities are also required to include
information about the availability of their grievance procedures and
how to file a grievance in their Notice of Nondiscrimination, per Sec.
92.10(a)(1)(vi). All covered entities, regardless of size, must also
include information in the Notice of Nondiscrimination on how to file a
discrimination complaint with OCR, per Sec. 92.10(a)(1)(vii).
In addition, the grievance process must be accessible to
individuals with LEP and individuals with disabilities, consistent with
section 1557 and this regulation. If an individual finds that a covered
entity's grievance process is generally overly burdensome to the point
it is ineffective or nonexistent and thus hindering the prompt and
equitable resolution of grievances, we recommend the individual file a
complaint with OCR.
Comment: Many commenters on this provision recommended that OCR
require all covered entities (not just those with 15 or more employees)
to have grievance procedures, while others either requested that OCR
maintain the 15-employee threshold or eliminate the requirement
altogether.
Commenters in support of eliminating the 15-employee threshold
contended that a covered entity's size does not protect patients from
discrimination and the threshold is inequitable because it deprives
patients of smaller covered entities the opportunity to directly engage
with the covered entity to address alleged discrimination. According to
commenters, individuals with disabilities face significant barriers to
care when seeking and receiving services from smaller covered entities,
and the 15-employee threshold unjustly deprives individuals with
disabilities of the opportunity to address these barriers through
grievances.
Further, commenters remarked that regulatory carve outs and
distinctions are confusing and difficult for both covered entities and
patients when determining applicable requirements and protections.
Commenters expressed concern that individuals from marginalized
communities would be confused about why they could not submit a
grievance with a covered entity with fewer than 15 employees simply due
to the size of the covered entity, when other requirements in the rule
apply regardless of covered entity size.
Commenters also raised the following issues countering inclusion of
a 15-employee threshold: the statutory text of section 1557 is not so
limited; the limitation is inconsistent with expanding section 1557's
application; an individual should have the ability to address
discrimination in the first instance directly to the covered entity;
and a covered entity with fewer than 15 employees that has grievance
procedures will be able to resolve discrimination complaints more
promptly at an earlier stage without formal OCR investigation.
Citing the burden on smaller covered entities, some commenters
requested that OCR maintain the grievance procedures requirement only
for covered entities with at least 15 employees, eliminate the
procedures altogether or utilize the SBA's definition of small
business.
Response: We appreciate commenters' concerns about the 15-employee
threshold and recognize that individuals are not immune from
experiencing discrimination when interacting with smaller covered
entities. However, OCR declines to apply this requirement to all
covered entities and note that this approach is consistent with OCR's
section 504 regulation, which similarly limits the grievance procedure
requirement. See 45 CFR 84.7(a). Individuals remain able to file
complaints with OCR when they experience discrimination in health
programs and activities and may also raise concerns to smaller covered
[[Page 37558]]
entities outside of a formal grievance process.
Given the benefits of having grievance procedures, we encourage
smaller covered entities to voluntarily implement such procedures,
which may help them more meaningfully engage with all individuals,
including members of underserved communities, and better identify
potential barriers to accessing their health programs and activities.
Comment: Some commenters pointed to the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) as precedent and
demonstrable evidence that the Department believes providers of all
sizes have the ability to comply with a Federal requirement to
implement a process for handling complaints. These commenters suggested
that all HIPAA-covered entities, including those with fewer than 15
employees, have experience implementing a process for receiving,
handling, and investigating privacy complaints, which these covered
entities can modify or replicate, if necessary, to include section 1557
discrimination grievances.
Response: OCR appreciates commenters' observation that HIPAA-
covered entities of all sizes have experience implementing a complaint
process. However, we are unpersuaded that the potential burden to
smaller covered entities with existing HIPAA complaint processes would
be minimal because these entities would need to revise their existing
policies, train relevant staff, and process civil rights-related
grievances in addition to processing HIPAA-related complaints. This is
similar to our position in response to comments received in response to
the 2015 NPRM. 81 FR 31395. Nothing in this rule prohibits entities of
fewer than 15 employees from voluntarily creating a grievance process.
Comment: In support of requiring all covered entities to have
grievance procedures, commenters suggested that covered entities could
have less extensive or detailed grievance procedures, and that such a
procedure would not need to involve significant staff or resources.
These commenters recommended that OCR develop model grievance
procedures for smaller covered entities to help them comply with the
grievance procedures requirement.
Response: To assist all covered entities--including those with
fewer than 15 employees that may wish to voluntarily implement a
grievance procedure--we have made available sample grievance procedures
on OCR's website at www.hhs.gov/1557. We note that the sample grievance
procedure available on OCR's website is more appropriate for smaller
covered entities, and we remind covered entities that the rule's
general Section 1557 Policies and Procedures requirement is founded on
the principle of scalability. Accordingly, the sample grievance
procedure on our website may not be adequate for a larger covered
entity or health system made up of several covered entities.
Comment: Many commenters supported the record retention requirement
at Sec. 92.8(c)(2). Under this provision, we proposed that covered
entities must retain records for a minimum of three (3) calendar years,
and each record must include the name and contact information of the
complainant, the alleged discriminatory action and alleged basis or
bases of discrimination, the date the grievance was filed, the
grievance resolution, and any pertinent information.
Some commenters expressed that this requirement will help covered
entities identify potential patterns and practices of discrimination of
which they may not have otherwise been aware. Other commenters who
supported this requirement expressed concern about patient privacy and
recommended that OCR require covered entities to deidentify information
related to the grievance during the retention period.
Response: We appreciate commenters' support for this new provision
and recognize the importance of ensuring patient privacy related to
recordkeeping. Section 92.8(c)(3) requires covered entities to keep
confidential the identity of the individual who submits a grievance,
subject to limited exceptions. We decline to revise the records
retention requirement to require covered entities to deidentify that
information related to the grievance.
Many section 1557 covered entities must also comply with the HIPAA
Privacy and Security Rules, which requires HIPAA covered entities to
protect and secure all protected health information that a covered
entity or business associate creates, receives, maintains, or
transmits. If a covered entity discloses an individual's protected
health information in violation of the HIPAA Rules, then the covered
entity is subject to OCR's HIPAA enforcement measures.\77\ If a section
1557 covered entity maintains grievance records beyond three (3)
calendar years, the covered entity may deidentify the information after
the records retention period has elapsed. Even where a section 1557
covered entity is not subject to HIPAA, that section 1557 entity must
still comply with all applicable Federal and State privacy laws.
---------------------------------------------------------------------------
\77\ See 45 CFR 160.312 and 160.400 through 160.414.
---------------------------------------------------------------------------
Comment: One commenter requested that OCR revise Sec. 92.8(c)(2)
so that a covered entity be required to retain only ``actionable''
grievances because large, covered entities may receive grievances that
are not related to section 1557's protections. This commenter gave an
example that a complaint may be employment-related, and therefore Sec.
92.8(c)(2) should not require a covered entity to retain such a
grievance.
Another commenter raised a similar concern and recommended that OCR
completely eliminate any record retention requirement as they relate to
grievances because it is difficult to know when a grievance triggers
the retention requirement. This commenter requested that, if OCR
retains the grievance records retention requirement, that it only apply
to covered entities with 15 or more employees.
Response: Section 92.8(c)(2) applies only to covered entities that
are required to have grievance procedures (i.e., those with 15 or more
employees), and this provision expressly specifies that covered
entities retain grievances it receives pursuant to the grievance
procedures requirement at Sec. 92.8(c)(1) that allege discrimination
on the basis of race, color, national origin, sex, age, or disability
in the covered entity's health programs or activities. Thus, covered
entities need not retain records pertaining to employment-related
grievances or grievances that do not allege discrimination based on
race, color, national origin, sex, age, or disability in the covered
entity's health programs or activities. If a covered entity cannot
determine whether a complaint relates to section 1557, the covered
entity should contact the complainant to obtain sufficient information
to either investigate the grievance or determine if the complaint
should be handled under a different process. We note that a covered
entity's dismissal of a grievance constitutes its resolution of the
grievance.
Comment: One commenter who expressed support for the retention
requirement opined that the proposed three-year retention period is
less burdensome than the seven-year retention requirement applicable to
most records for hospice and palliative care. Another commenter
recommended that covered entities be required to retain grievance-
related records permanently due to the low costs associated with
maintaining these records electronically, and a covered entity could
find older records useful in
[[Page 37559]]
litigation. Another commenter recommended that OCR adopt a four-year
retention period to match section 1557's four-year statute of
limitations \78\ because a retention period shorter than section 1557's
statute of limitations would prevent private litigants from obtaining
grievance-related evidence relevant to a section 1557 claim. One
commenter also recommended that OCR revise Sec. 92.8(c)(2) so that the
timeframe for covered entities to retain grievance records starts once
the covered entity resolves the grievance rather than when the covered
entity receives it.
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\78\ See, e.g., Tomei v. Parkwest Med. Ctr., 24 F.4th 508, 515
(6th Cir. 2022) (holding the catchall Federal statute of limitations
at 28 U.S.C. 1658(a) applies to claims under section 1557 because
section 1557 lacks an express statute of limitations); but see Solis
v. Our Lady of the Lake Ascension Cmty. Hosp., Inc., No. CV 18-56-
SDD-RLB, 2020 WL 2754917, at *4 (M.D. La. May 27, 2020) (applying
the Rehabilitation Act statute of limitations to a section 1557
claim of disability discrimination).
---------------------------------------------------------------------------
Response: OCR has determined that the three-year record retention
requirement strikes the appropriate balance between covered entities'
burden concerns and the need for OCR to access this vital information
in the course of a complaint investigation or compliance review. As
stated in the 2022 NPRM, we understand that many covered entities
already have a practice of retaining grievance records, and nothing in
this rule prevents a covered entity from retaining records longer if
they so choose. 87 FR 47849.
We appreciate commenters' recommendation that OCR specify that the
retention obligation starts on the date that the covered entity
resolves the grievance rather than on the date that the complainant
filed the grievance, and we are revising Sec. 92.8(c)(2) to reflect
this change. Grievances take varying amounts of time to resolve, and
starting the retention obligation on the date of receipt could
potentially result in a covered entity disposing of records pertaining
to a grievance prior to the resolution of the grievance. This change
necessitates that we further revise Sec. 92.8(c)(2) to require a
covered entity's grievance records also include the date that the
covered entity resolved a grievance.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the Grievance Procedure
requirement provision at Sec. 92.8(c) as proposed, with modifications.
We are revising Sec. 92.8(c)(2) to explain that the grievances that a
covered entity must retain are those filed pursuant to its grievance
procedures required by Sec. 92.8(c)(1) that allege discrimination
based on race, color, national origin, sex, age, and disability in a
covered entity's health programs or activities, and that the records
include the date the grievance was resolved. We are also clarifying at
Sec. 92.8(c)(2) that the retention period for grievance procedures
starts on the date the covered entity resolves the grievance.
Language Access Procedures
Comment: Most commenters on this provision expressed support for
the proposed language access procedures requirement at proposed Sec.
92.8(d). Some commenters recommended that OCR revise Sec. 92.8(d) to
make clear that a covered entity's language access obligations extend
to companions of patients, beneficiaries, enrollees, and applicants.
Response: It has been OCR's practice to require covered entities to
provide language assistance services for LEP companions of patients,
beneficiaries, enrollees, and applicants when necessary. Rather than
revising Sec. 92.8(d), we are revising Sec. 92.201 (Meaningful access
for individuals with LEP) to codify this requirement. We discuss this
further when addressing comments related to Sec. 92.201. Because the
language access procedures are intended to assist covered entities in
complying with their language access obligations under Sec. 92.201,
they should ensure that companions are included.
Comment: One commenter recommended that OCR allow covered entities
the flexibility to identify the process and business rules that they
currently use to identify individuals with LEP, how to provide language
assistance services, and how to create and store translated materials
and resources. This commenter suggested that Sec. 92.8(d) reads as if
it is intended for smaller covered entities that provide language
assistance services in an ad hoc manner.
Response: Section 92.8(d) applies to covered entities of all sizes,
allowing flexibility for covered entities to scale their language
assistance services procedures as needed. Section 92.8(d) does not
restrict the manner in which a covered entity implements its language
access procedures, which may include the use of pre-existing business
tools that meet the necessary requirements. For example, Sec. 92.8(d)
does not dictate how covered entities' employees identify individuals
with LEP or how covered entities obtain language assistance services
from qualified interpreters and translators (i.e., through contract
interpreters, in-house interpreters, etc.).
Comment: Some commenters indicated that often patients with LEP
have to repeat a language access intake process with every visit to a
covered entity, even when they have already gone through such a process
and their language access needs have been previously identified by the
covered entity. To avoid this situation, commenters recommended that
OCR require covered entities to note in a patient's records whether the
patient needs language assistance services, and if so, the specific
language and services needed.
Response: OCR understands that repeatedly having to request
necessary language assistance services from the same covered entity can
be frustrating and may result in wasted time or the cancellation of an
appointment if the needed services are unavailable. While the
commenters' suggestion for covered entities to document the specific
language assistance services needs in the patient with LEP's record is
a best practice that we encourage for inclusion in a covered entities'
language access procedures, OCR declines to revise Sec. 92.8(d). As
drafted, the provision allows covered entities the flexibility needed
to comply.
Comment: Some commenters requested that OCR revise Sec. 92.8(d)
with text: (1) directly from Sec. 92.201 related to covered entities'
obligation to provide each individual with LEP with meaningful access;
and (2) that aligns with Executive Order 13166 (``Improving Access to
Services for Persons with Limited English Proficiency''); \79\ title
VI; Medicaid's commitment to enhancing access through culturally
competent care as defined in 42 CFR 440.262; and the Agency for
Healthcare Research and Quality's ``Improving Patient Safety Systems
for Patients with Limited English Proficiency'' guide.\80\
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\79\ E.O. 13166, 65 FR 50121 (Aug. 11, 2000).
\80\ U.S. Dep't of Health & Hum. Servs., Agency for Healthcare
Rsch. and Quality, Improving Patient Safety Systems for Patients
With Limited English Proficiency: A Guide for Hospitals (2012),
https://www.ahrq.gov/sites/default/files/publications/files/lepguide.pdf.
---------------------------------------------------------------------------
Response: Section 92.8(d) already references covered entities'
obligations under Sec. 92.201, so it is unnecessary to restate that
language here. We decline to modify the provision to add language from
the suggested requirements and resources, as this provision relates to
covered entities' obligation under section 1557.
Comment: Many commenters sought clarity about whether the language
[[Page 37560]]
access ``procedures'' required by Sec. 92.8(d) differ from documents
commonly referred to as language access ``plans.'' Noting OCR's
longstanding recognition of the benefits of having a language access
plan, as expressed in 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), 68 FR 47311 (Aug. 8, 2003), many
commenters recommended that OCR modify Sec. 92.8(d) to clarify that
covered entities must develop and implement a language access plan
before developing language access procedures because developing
effective policies and procedures require such advance planning and
give covered entities clear policies to follow when seeing patients
with LEP.
According to these commenters, formal language access plans require
a covered entity to consider and evaluate the needs of a service area,
providing a better understanding of populations, prevalence of specific
language groups, language access needs, and scope of services needed to
provide meaningful access. Commenters highlighted the rapid growth of
pockets of individuals with LEP with distinct language and cultural
conventions, including indigenous immigrant populations from Central
and South America, and the changing language needs for recent arrival
of refugees from Afghanistan, Ukraine, Russia, and other non-English
speaking countries.
In contrast, one commenter appreciated that the Proposed Rule did
not require covered entities to implement language access plans and
noted that small, covered entities lack resources, including time,
administrative effort, and financial resources to implement a language
access plan. Citing the 2015 NPRM, the commenter stated the cost to
develop a language access plan at $1,135 per small, covered entity,\81\
and recommended that OCR finalize the rule without requiring covered
entities to develop and implement a language access plan.
---------------------------------------------------------------------------
\81\ The $1,135 figure is derived from the 2015 NPRM for section
1557 on ``training costs'' for small entities. See 80 FR 54213.
---------------------------------------------------------------------------
Response: OCR appreciates commenters' emphasis on the value of
language access plans, which as commenters noted, are distinct from the
language access procedures required under this section. Covered
entities are not explicitly required to analyze the specific
populations with LEP in their service areas. However, in order to
develop effective language access procedures and ensure compliance with
the obligations at Sec. 92.201, a covered entity will need to engage
in some form of analysis to identify the language access needs in their
service area.
For example, when finalizing a list of preferred language
assistance services providers, a covered entity will need to determine
which providers are most capable of meeting the language needs of the
individuals with LEP within the service area. To best inform its
decision-making process, a covered entity may first attempt to identify
the non-English languages most spoken in the relevant service area and
confirm that interpreter and translation service providers can
accommodate those languages. The HHS LEP Guidance, cited by commenters,
is still instructive and relevant and provides helpful information in
how to develop a strategy for delivery of language assistance services.
See 68 FR 47313-22. Covered entities are also encouraged to use the
language access planning resources provided at https://www.lep.gov/language-access-planning or reference HHS's 2023 Language Access Plan
for guidance at https://www.hhs.gov/sites/default/files/Language-Access-Plan-2023_0.pdf.
Covered entities with language access plans are often better
prepared to provide individuals with LEP with meaningful access to
their health programs and activities. For covered entities that have
developed, implemented, and maintained language access plans, we highly
encourage those covered entities to sustain that practice and to
consider modifying their plans to include the elements required by
Sec. 92.8(d), to the extent it is not already included. To the extent
a covered entity's language access plan meets the requirements of Sec.
92.8(d), a separate procedures document will not be required regardless
of whether the document is referred to as a ``plan'' or ``procedures.''
Comment: Some commenters recommended that OCR delete the
requirement in Sec. 92.8(d) for covered entities to identify the names
of qualified bilingual/multilingual staff members due to employee
turnover, with one commenter also requesting that OCR eliminate the
requirement to maintain a list and location of electronic and written
translated materials because such a requirement would be an onerous,
inefficient use of time due to frequent changes to translated
materials. Another commenter indicated that these requirements are
especially difficult for large, covered entities, and that health
insurance issuers in particular should have the option to provide
business rules and rationale with respect to how and where they store
documents rather than create a duplicative process. This commenter also
recommended that OCR allow covered entities to articulate the process
for accessing language services and contact information for the covered
entity's department or functional group responsible for translations.
Response: OCR acknowledges that covered entities may need to
periodically revise their language access procedures to reflect changes
to qualified bilingual/multilingual staff; however, these staff members
play a critical role in the delivery of timely language assistance
services and therefore it is imperative that employees be able to
identify qualified bilingual/multilingual staff members as quickly as
possible through the use of a current directory. We decline to remove
the requirement that language access procedures include a current list
of qualified bilingual/multilingual staff members.
Timely and effective language assistance services are also best
served by maintaining a current list of translated materials. OCR notes
commenters' concerns regarding the practicality and burden of
maintaining a list of the physical location of all written translated
materials. For this reason, we are revising the requirement to no
longer require the location of written translated materials, but only
how to access electronic translated materials (i.e., their location on
a covered entity's network, intranet, or external-facing website).
Section 92.8(d) requires covered entities to include contact
information for their Coordinator and how employees obtain services of
qualified interpreters, translators, and multilingual/bilingual staff.
This allows for covered entities to articulate the process for
accessing language services; if this function has been delegated to a
department or functional group, contact information for that department
or functional group should be included in the language access
procedures.
Comment: Some commenters recommended that the Department secure
resources for small, covered entities to support their provision of
language assistance services. For example, one commenter recommended
that OCR contract with a telephonic interpretation service and allow
small, covered entities to opt-in to using that service. Another
commenter suggested that OCR partner with the U.S. Department of
Education to invest in medical interpreter training for smaller
language communities because investing in these communities would
[[Page 37561]]
result in higher quality health care. Another commenter requested that
OCR make available sample policies and procedures; best practices for
working with language assistance companies, identifying qualified (and
unqualified) interpreters, and producing accurate and quality
translations; and training videos.
Response: OCR appreciates these commenters' suggestions for
providing resources to assist small, covered entities and, we are
committed to making sample language access procedures available on our
website at www.hhs.gov/1557. However, it is not appropriate for OCR, as
a Federal agency, to endorse private interpreter or translator service
providers. We are also unable to provide a telephonic interpretation
contract into which small, covered entities could voluntarily
participate.
OCR also appreciates the importance of interpreter training for
less frequently encountered languages and is committed to developing a
robust health care work force. To illustrate this commitment, the
Department announced a ``Promoting Equitable Access to Language
Services in Health and Human Services'' initiative in Fall 2022, for
which grants were awarded to 11 organizations to develop and test
methods of informing individuals with LEP about the availability of
language assistance services in health care settings.\82\
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\82\ U.S. Dep't of Health & Hum. Servs., Off. of Minority
Health, FY 2022 Grants Awards: Promoting Equitable Access to
Language Services in Health and Human Services (October 11, 2022),
https://minorityhealth.hhs.gov/fy-2022-grant-
awards#:~:text=Grant%20period%3A%202022%2D2025,in%20health%20care%2Dr
elated%20settings.
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the Language Access procedures
requirement provision at Sec. 92.8(d) as proposed, with modifications.
We are revising Sec. 92.8(d) to require language access procedures to
strike the requirement to include the location of any written or
electronic materials and adding a requirement to include ``how to
access electronic translations.'' We replaced ``publication date'' with
``date of issuance'' to better account for translated materials that
may be in hard copy or electronic format. We are also making one
technical revision. We are replacing ``limited English proficient
individual'' with ``individual with limited English proficiency,''
consistent with modifications elsewhere.
Effective Communication Procedures
Comment: Comments related to proposed Sec. 92.8(e), regarding
effective communication procedures, were similar to the language access
procedures comments. Many commenters requested that OCR require covered
entities to develop and implement a broad ``communication access
plan,'' which would address effective communication and accessibility
for individuals with disabilities, including individuals with
disabilities who also have LEP. Commenters recommended that covered
entities be required to develop communication access plans prior to
developing their effective communication procedures. Some commenters
suggested that a covered entity's effective communication procedures
should also include how to determine the sign language an individual
with a communication disability uses and whether the individual needs
the services of an interpreter team, such as a certified deaf
interpreter and an American Sign Language interpreter. One commenter
recommended that we add a requirement for covered entities to create
section 1557, ADA, and section 504 communication access plans along
with the effective communication procedures requirement.
Response: Advance planning is an essential component of developing
and implementing effective procedures that will ensure compliance with
the obligations at Sec. 92.202, which necessitate consideration of the
various aids and services that may be required to deliver effective
communication. Thus, while covered entities are not explicitly required
to engage in advance planning, their ability to comply with Sec.
92.202 will be best supported though robust procedures that are
developed though a thoughtful and thorough process.
Covered entities may include more information in their respective
effective communication procedures than Sec. 92.8(e) requires, and we
encourage covered entities that are already implementing communication
access plans to maintain that practice. Covered entities with active
communication access plans are permitted to modify such plans to
include the information required by Sec. 92.8(e); to the extent a
covered entity's communication access plan meets the requirements of
Sec. 92.8(e), a separate procedures document will not be required
regardless of whether the document is referred to as a ``communication
access plan'' or ``effective communication procedures.'' While OCR
appreciates the similarities between section 1557, section 504, and
ADA's effective communication requirement, section 1557 is a distinct
statute and imposing requirements for a similar procedure under the ADA
and section 504 is outside the authority of this rulemaking.
Comment: One commenter requested that OCR make clear in the final
rule that covered entities must implement effective communication and
language access requirements in a well-coordinated, comprehensive,
seamless, and equally effective manner such as through a standard
operating procedure. This commenter also recommended that we inform
covered entities that effective communication and language access
requirements are of equal, paramount importance and closely
interdependent with each other, and the commenter suggested that we
issue guidance recommending effective communication and language access
coordination.
Response: We agree with the commenter that effective communication
and language access requirements are equally important, and effective
communication and language access requirements can be interdependent,
particularly when communicating with individuals with disabilities who
have LEP. Though covered entities would ideally implement their
effective communication and language access requirements in a well-
coordinated, comprehensive, seamless, and equally effective manner, we
decline to revise either paragraph (d) or (e) of Sec. 92.8 or include
any additional regulatory provisions imposing such standards on covered
entities, in part, because such standards would be difficult to
objectively measure.
Comment: Another commenter recommended that we revise Sec. 92.8(e)
to require covered entities' effective communication procedures include
information about how covered entities will assess staff members'
competency as qualified interpreters or qualified readers.
Response: We discuss assessment of interpreters at Sec. 92.4;
because of the flexibility allowed by the definition regarding how a
covered entity chooses to assess the qualifications of interpreters
(and readers), we decline to require this information be included in
the procedures.
Comment: Some commenters recommended that OCR clarify that a
covered entity's effective communication procedures apply to
individuals with any disability that affects an individual's ability to
communicate. Further, these
[[Page 37562]]
commenters also requested that we clarify that a covered entity's
auxiliary aids and services options are not limited to qualified
interpreters. Another commenter recommended that we include examples of
accommodations, assistance, and opportunities for individuals with
speech-related disabilities in the preamble and accompanying guiding
documents.
Response: Covered entities' effective communication
responsibilities, further discussed at Sec. 92.202, apply to
communication with all people with disabilities and a covered entity's
effective communication procedures must equip employees with the
information and tools necessary to meet the needs of individuals with
many different types of disabilities. These may include, but are not
limited to, sensory, manual, or speaking disabilities. Covered
entities' obligations to provide auxiliary aids and services extend
beyond qualified interpreters. A non-exhaustive list of auxiliary aids
and services can be found in the definition of ``auxiliary aids and
services'' in Sec. 92.4.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the Effective Communication
Procedures requirement provision at Sec. 92.8(e) as proposed, without
modifications.
Reasonable Modification Procedures
Comment: Many commenters supported the reasonable modification
procedures requirement under proposed Sec. 92.8(f), with some noting
that many covered entities, particularly smaller covered entities, are
unaware of their obligation to reasonably modify their policies and
procedures when necessary to avoid discrimination on the basis of
disability. Some commenters recommended that OCR proactively provide
examples of the types of reasonable modifications that covered entities
should consider as a means of increasing the likelihood that a covered
entity's reasonable modifications procedures are adequate. One
commenter urged OCR to include a statement in the final rule's preamble
or guidance that a reasonable modification can include communicating in
a more accessible modality (e.g., via email), if the patient requests
it.
Response: It is OCR's intent that requiring a reasonable
modification procedure will address the lack of knowledge on behalf of
covered entities that commenters raised, and will increase covered
entities' ability to respond appropriately to requests. OCR believes
this will raise overall compliance with the requirement at Sec. 92.205
to provide reasonable modifications, and will benefit both covered
entities and individuals seeking access to health programs or
activities.
The vast range of potential reasonable modifications available or
necessary do not lend themselves to an exhaustive list and so we are
not able to include such a list here. However, many reasonable
modifications involve reasonable changes in the way that an entity does
something or permits an individual to do something. For example, a
covered entity that generally communicates with patients via phone but
receives a request from an individual with a disability to receive
communication via email as a modification should generally grant that
request, unless the covered entity can demonstrate that doing so would
fundamentally alter the nature of the health program or activity. Other
examples include allowing an individual with a disability whose
disability makes attending morning appointments difficult to schedule
afternoon appointments when appointments may not generally be available
at that time, or allowing an individual with a disability to attend
appointments via telehealth instead of in person when such modification
does not fundamentally alter the nature of the service being provided.
To be clear, there is no exhaustive list of what constitutes a
reasonable modification, nor must covered entities develop one. Rather,
covered entities are required to implement written procedures
describing their process by which an individual with a disability may
request a reasonable modification and how a covered entity processes
and responds to such requests.
Comment: One commenter stated that a covered entity must provide
reasonable modifications to an individual with a disability in the
absence of an affirmative request for the modification if the covered
entity had knowledge of the individual's disability or when the
individual's disability is obvious. Relatedly, another commenter
requested that OCR revise Sec. 92.8(f) to reflect that an individual's
failure to request a reasonable modification does not always excuse the
covered entity from providing a reasonable modification if the
modification does not result in a fundamental alteration.
Response: Section 92.8(f) is an administrative requirement to
implement a procedure by which a reasonable modification can be
requested, evaluated, and granted. However, as noted in the 2022 NPRM,
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 the modification
would not result in a fundamental alteration of the health program or
activity. 87 FR 47850. For example, when a covered entity has 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.\83\
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\83\ 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. Cnty. 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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Comment: Some commenters noted a common occurrence where patients
with disabilities must repeatedly request the same reasonable
modifications or auxiliary aids and services from the same covered
entity for each visit. These commenters urged OCR to include additional
language in the final rule preamble and guidance for covered entities
to minimize patients' burdens of having to repeatedly notify, request,
monitor, and enforce the covered entity's obligation to remove access
barriers.
Response: These commenters' recommendations mirror similar comments
related to experiences of patients with LEP who must repeatedly request
the same language assistance services from the same covered entity.
Such a practice may be inefficient and may violate the requirements of
this part if they result in the delay or denial of access to a health
program or activity. See discussion of Sec. 92.201. While we strongly
recommend that covered entities engage in the best practice of
documenting in patients' medical records the specific reasonable
modifications requested by patients with disabilities, in an effort to
avoid overly prescriptive requirements we decline to revise Sec.
92.8(f).
Comment: Commenters recommended that OCR require covered entities
to appoint an individual to ensure compliance with the reasonable
modification requirement. This person would: inquire whether patients
need communications-related modifications; ensure such modifications
are provided promptly; and monitor the patient's stay
[[Page 37563]]
to ensure the modification is provided through the duration of the
entire stay. This person would also be responsible for ensuring the
covered entity is otherwise complying with the requirement to provide
auxiliary aids and services.
Response: This rule, at Sec. 92.7, requires designation of a
Section 1557 Coordinator by covered entities that employ 15 or more
persons. The Coordinator is responsible for ensuring compliance with
section 1557's requirements, including the requirement to provide
auxiliary aids and services at Sec. 92.202 and to make reasonable
modifications at Sec. 92.205. A covered entity may delegate
responsibility for the actual provision of auxiliary aids and
reasonable modifications, and implementation of the corresponding
procedures, to an individual other than the Coordinator, such as a
designee; however, we decline to require the designation of an
additional employee to implement these requirements.
Comment: One commenter recommended that OCR revise the regulatory
text for Sec. 92.8(f) to substitute the modifier ``reasonable'' with
``reasonable and appropriate.''
Response: We decline to adopt the commenter's suggested regulatory
revision because ``reasonable modification'' is a term of art with a
long history of enforcement in the disability context. We note that,
consistent with similar longstanding disability rights law enforcement,
we use ``appropriate'' in Sec. Sec. 92.8(e) and 92.202(b) when
describing the auxiliary aids and services that a covered entity must
use to effectively communicate with individuals with disabilities.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the Reasonable Modification
Procedures requirement provision at Sec. 92.8(f) as proposed, without
modifications.
Training (Sec. 92.9)
In Sec. 92.9, we proposed requiring covered entities to train
relevant employees in their health programs and activities on their
Section 1557 Policies and Procedures.
In Sec. 92.9(a), we proposed 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.
In Sec. 92.9(b), we specified when covered entities must train
relevant employees on their Section 1557 Policies and Procedures.
In Sec. 92.9(b)(1), we proposed that 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.
In Sec. 92.9(b)(2), we proposed that covered entities train new
relevant employees within a reasonable period of time after they join a
covered entity's workforce.
In Sec. 92.9(b)(3), we proposed requiring covered entities to
train relevant employees whose roles are affected by material changes
to the covered entity's Section 1557 Policies and Procedures and any
other civil rights policies or procedures the covered entity has
implemented.
In Sec. 92.9(c), we proposed requiring covered entities to
contemporaneously document their employees' completion of the training
required by this section in written or electronic form and maintain
said documentation for no less than three (3) calendar years.
We invited 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 their existing
annual compliance training, what types of changes would constitute a
material change such that a covered entity would need to retrain staff,
and how long training records must be retained. We also sought 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 requested 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.
The comments and our responses regarding Sec. 92.9 are set forth
below.
Comment: Many commenters on this provision expressed support for
the training requirement and provided a range of reasons, including
because the training is intended to impart knowledge and awareness of
civil rights requirements and responsibilities; it will serve as an
additional safeguard against discrimination and help reduce health
disparities; and it will help providers connect patients to the
services they need.
Commenters believed that a covered entity's staff need to
understand section 1557 requirements, especially considering increased
instances of employee turnover. One commenter also encouraged OCR to
repeat the language in the Proposed Rule and remind covered entities
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.'' 87 FR 47850.
Some commenters said that civil rights violations occur due to lack
of awareness and that training on covered entities' Section 1557
Policies and Procedures will help eliminate discrimination in health
care because it promotes knowledge about how to deliver and administer
health programs and activities to all patients, including patients who
are members of communities that have experienced discrimination in
health care services.
Some commenters suggested that OCR provide additional detail
regarding the contents and delivery of the training, including by being
more explicit about the nature and standards for determining adequacy
of training. Conversely, one commenter recommended that OCR not make
the training requirement overly prescriptive, and another asked OCR to
give covered entities the authority to determine the training elements
that best fit covered entities' operations.
Some commenters opposed the training requirement, referencing
existing compliance burdens for providers, particularly small
providers. Some commenters requested that OCR abandon the training
requirement in the final rule because the requirement lacks
specificity, is weak, vague, difficult to enforce, ineffective, will
require more paperwork, and will confuse specialty clinics like dental
offices; one commenter requested that OCR specifically exempt
dermatology practices from the training requirement.
Many of the commenters that opposed the training requirement added
that, if the rule is finalized as proposed, OCR should develop and
provide educational materials and training resources, including
materials to test trained employees' understanding of the new
requirements.
Response: Section 92.9 requires covered entities to train relevant
employees on their tailored Section 1557 Policies and Procedures, which
will serve as a proactive safeguard against discrimination. Given this
benefit, we decline to remove this
[[Page 37564]]
provision or exempt specific fields of practice from compliance with
this requirement.
Recognizing the resources needed to comply with the training
requirement, Sec. 92.9 allows covered entities flexibility in
designing the training they provide. However, the efficacy of the
training--and its civil rights compliance benefit--will depend on a
covered entity's effort in developing and conducting the training.
OCR's experience with enforcing HIPAA's training requirement, 45 CFR
164.530(b), has found that employee-related violations are more limited
where the required HIPAA training is routinely provided compared to
where it is not. We anticipate that the section 1557 training
requirement will similarly result in covered entities' employees being
more aware of section 1557's discrimination prohibitions and establish
a foundation by which covered entities' employees more consistently
comply with nondiscrimination requirements.
With respect to the commenters' view that the training requirement
will be difficult to enforce, the document retention requirement in
Sec. 92.9(c) is designed to assist with this. Moreover, OCR has been
successfully enforcing HIPAA covered entities' compliance with HIPAA
training requirements for more than 20 years. Through investigations,
OCR evaluates covered entities' compliance with training requirements,
and, when necessary, OCR ensures that a covered entity takes corrective
actions to comply with said requirement.
To support compliance with this rule, OCR has made materials
available on our website at www.hhs.gov/1557; however, the training
required under Sec. 92.9 must be based on the covered entity's own
policies and procedures. Thus, while OCR is providing general resources
on section 1557 requirements, they must be supplemented by the covered
entity to include information regarding their specific Section 1557
Policies and Procedures.
Comment: Several commenters asked OCR to clarify whether covered
entities could incorporate training on their Section 1557 Policies and
Procedures with existing employee and annual compliance training
instead of mandating a stand-alone training. One commenter recommended
that covered entities train their employees on their respective Section
1557 Policies and Procedures separately because combining this training
can result in information overload if employees are trained on multiple
issues at the same training.
Response: This rule does not require or prohibit covered entities
from incorporating the training required under Sec. 92.9 with pre-
existing employee or annual compliance trainings. We encourage covered
entities to regularly train employees on their Section 1557 Policies
and Procedures, possibly alongside other annual compliance trainings,
and we recommend that covered entities offer section 1557 trainings in
a manner that will result in maximum knowledge retention. While the
rule does not specify the frequency with which trainings must be
provided, covered entities should keep in mind that they must train new
employees within a reasonable period of time after the employee joins a
covered entity's workforce.
Comment: We received several comments recommending that OCR clarify
the term ``relevant employees'' who must be trained under Sec. 92.9.
Many commenters recommended that we define ``relevant employees'' in
the final rule's definitions section at Sec. 92.4 or within Sec. 92.9
itself. Some commenters suggested that ``relevant employees'' should
include: employees whose roles and responsibilities require interfacing
with patients and the public; employees who make decisions about
patient care and covered entity operations that impact patient care;
employees in leadership and supervisory roles who make decisions that
affect nondiscrimination; and employees, including C-suite leadership
(i.e., the chief executive officer, chief financial officer, chief
operating officer, and chief information officer), who are responsible
for executing and making decisions regarding financial assistance,
patient billing, and collections. Citing the importance of interactions
between covered entities and patients in the long-term services and
supports context, one commenter recommended that ``relevant employees''
should include temporary staff who interact with the public or clients.
Response: We appreciate commenters' recommendations to define
``relevant employee.'' Though we described a covered entity's relevant
staff who must receive the training required in the 2022 NPRM, 87 FR
47851, based on comments received, we agree that including more
specificity in the final rule text will add additional clarity for
covered entities. We have provided a description of ``relevant
employee(s)'' in new Sec. 92.9(b)(4), which that, for purposes of the
section, ``relevant employees'' includes employees whose roles and
responsibilities entail interacting with patients and members of the
public; making decisions that directly or indirectly affect patients'
health care, including the covered entity's executive leadership team
and legal counsel; and performing tasks and making decisions that
directly or indirectly affect patients' financial obligations,
including billing and collections. Below, we specify that relevant
employees may include temporary employees in addition to permanent
employees and have revised the regulatory text accordingly.
Comment: Other commenters recommended that OCR require covered
entities to train all of their employees on the covered entities'
Section 1557 Policies and Procedures because all employees may
encounter a patient at any time, and they should understand basic
section 1557 concepts. One commenter suggested that if OCR does not
require covered entities to train all of their employees, then we
should broaden who we consider to be ``relevant employees'' because
employees who do not have direct patient interaction or policy-making
roles may still have section 1557 responsibilities, and many of these
employees are likely to engage in incidental patient interaction during
the course of their work.
Response: A covered entity has the discretion to train all of its
employees to eliminate the burden of determining who the covered entity
believes is and is not a relevant employee. OCR notes that an employee
who makes decisions that indirectly affect patients' health care or
financial obligations meets the definition for ``relevant employee'' at
Sec. 92.9(b)(4), and therefore a covered entity would need to train
such an employee pursuant to this provision. However, given the
diversity of covered entities under this rule, we decline to mandate
training for all staff. For example, to do so may cause confusion for
covered entities that operate a health program that is part of a larger
operation (e.g., a retail grocery store that also operates a covered
pharmacy).
Comment: Some commenters recommended that, due to high staff
turnover and the common practice of hiring temporary, contract, or
travel staff, OCR should consider allowing temporary staff to transfer
prior, completed training from one facility to another to limit burden
and redundancy. These commenters also asked OCR to permit training
completion documentation from one covered entity to meet the
documentation requirement for another covered entity as a means to
limit burden and redundancy.
Response: Section 92.9 requires a covered entity to train employees
on its
[[Page 37565]]
specifically tailored Section 1557 Policies and Procedures. Thus,
Covered Entity A's Section 1557 Policies and Procedures will be
different from Covered Entity B's Section 1557 Policies and Procedures,
and therefore a temporary employee's training on Covered Entity A's
policies and procedures will not be transferable to Covered Entity B.
Though temporary, contractor, and travel employees may be with an
entity for a limited amount of time, that does not minimize the
likelihood that these employees may still encounter an individual with
LEP or an individual with a disability who may need language assistance
services, effective communication, or a reasonable modification.
Covered entities that hire temporary, contract, and travel employees
will still need to train these employees, document such training, and
maintain that documentation for the requisite amount of time. We note
that this approach is consistent with OCR's enforcement of the HIPAA
training requirement.
Comment: Several commenters requested that OCR require covered
entities to train their employees beyond their respective Section 1557
Policies and Procedures. For example, commenters suggested that OCR
require covered entities to train their employees on a variety of
issues including: how to work with interpreters (in person, over the
telephone, and via remote video); cultural competence, including how
employees should address stigma experienced by individuals with LEP and
individuals with disabilities; interacting with people with
disabilities (including individuals who are deaf, hard of hearing,
deafblind, and deaf-disabled); and how to competently address
transgender and nonbinary patients.
Some commenters recommended that covered entities invite
individuals with disabilities and other diverse backgrounds to help
conduct required training because learning from people with lived
experiences will help covered entities achieve effective communication
and reduce biases. Another commenter recommended that OCR work with
stakeholders to develop appropriate training materials.
Response: We encourage covered entities to consider investing in
their workforces by providing employees additional civil rights and
nondiscrimination training beyond what Sec. 92.9 requires. For
example, covered entities may deploy interactive civil rights trainings
that involve questions and answers and that more actively engages
participants rather than the use of training formats like pre-recorded
sessions to maximize comprehension of complex civil rights concepts.
OCR also acknowledges that hiring, collaborating with, or otherwise
engaging individuals with disabilities and other individuals from
underserved communities to provide input on training (and the
underlying Section 1557 Policies and Procedures) is a best practice.
Further, engaging with these same groups to provide training regarding
best practices and other civil rights-related issues will give a
covered entity's employees valuable perspective about the importance of
delivering compassionate, inclusive, and responsive health care.
However, we decline to expand the scope of the training requirement
at this time. It is our position that the training on the Section 1557
Policies and Procedures required in Sec. 92.9 strikes the appropriate
balance between covered entities' burden concerns and the need for
awareness of this vital information. We note that OCR has provided a
general resource on section 1557 requirements that can supplement
covered entities' Section 1557 Policies and Procedures training,
available at www.hhs.gov/1557.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing Sec. 92.9 as proposed, with
modifications. We are revising Sec. 92.9(b)(1) to specify that a
covered entity must begin training its relevant employees no later than
30 days after a covered entity implements its policies and procedures
required by Sec. 92.8 and no later than 300 days after the effective
date of the part. We are including a definition of ``relevant
employee(s),'' for purposes of the section only, at Sec. 92.9(b)(4) to
provide: ``for the purposes of this section `relevant employees'
includes permanent and temporary employees . . . .'' Lastly, we are
modifying Sec. 92.9(c) to clarify that covered entities are required
to retain (rather than ``maintain'') training documentation for the
requisite time period.
Notice of Nondiscrimination (Sec. 92.10)
In Sec. 92.10(a), we proposed requiring 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 (``Notice of Nondiscrimination''). Section 92.10(a)(1)
proposed the required contents of the Notice of Nondiscrimination.
Section 92.10(a)(2) proposed when and where covered entities must
provide the Notice of Nondiscrimination.
In Sec. 92.10(b), we proposed that a covered entity may combine
the content of the notice required by Sec. 92.10(a) of this section
with the notices required by title VI, section 504, title IX, and the
Age Act implementing regulations \84\ if the combined notice clearly
informs individuals of their civil rights under section 1557 and the
part and meets the requirements outlined in proposed Sec. 92.10(a)(1).
---------------------------------------------------------------------------
\84\ 45 CFR 80.6(d) (title VI); 84.8 (section 504, federally
assisted); 85.12 (section 504, federally conducted); 86.9 (title
IX); 91.32 (Age Act).
---------------------------------------------------------------------------
We invited 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 contents of the notice and
requirements regarding when and where covered entities must provide
this notice. We sought comment on the best ways to provide an
accessible notice to individuals with disabilities who may require
auxiliary aids and services and the best way in which to provide the
notice in a manner accessible to individuals with LEP.
The comments and our responses regarding Sec. 92.10 are set forth
below.
Comment: Many commenters strongly support the notice requirements
set forth in Sec. Sec. 92.10 and 92.11 (Notice of Availability),
stating that such notices are needed to help people know their rights
and will reduce health disparities, especially for persons with LEP and
persons with disabilities. Some organizational commenters added that
when the 2016 Rule's notice requirement, former 45 CFR 92.8, was
removed by the 2020 Rule, many people did not know their rights, how to
access interpreters or auxiliary aids and services, or how to file a
grievance. Several commenters added that a clear explanation of rights
and contact information for the Section 1557 Coordinator, as set forth
in Sec. 92.10(a)(1)(v), is crucial. Some disability rights groups
commented that not only should the Section 1557 Coordinator's contact
information be included, but also that of the ADA Coordinator.
Response: The Notice of Nondiscrimination is a critical means by
which to inform individuals of their civil rights, which is part of a
proactive civil rights compliance structure that functions--in part--
through grievances and complaints raised by individuals. We decline to
require inclusion of contact information for an ADA
[[Page 37566]]
Coordinator as this regulation is limited to section 1557; further, not
all covered entities under this rule are subject to the ADA.
Comment: Various covered entities commented that the burden of the
notice provisions is compounded by the complexity of having two
separate notices (i.e., the Notice of Nondiscrimination and the Notice
of Availability) and the requirements to provide information in 15
languages.
Response: OCR takes seriously the concerns raised by some
commenters regarding burden. In crafting the two distinct notice
requirements, OCR considered comments received in response to the 2015
and 2019 NPRMs regarding the burden of a notice requirement. The
provisions in the final rule reflect careful consideration of what must
be included in each notice, and they include substantially more clarity
regarding when and where each notice must be provided compared to the
2016 Rule.
We note that there is not a requirement that ``all information'' be
provided in multiple languages; the requirement is that the Notice of
Availability required by Sec. 91.11 be provided in 15 non-English
languages to inform individuals of the availability of language
assistance services and auxiliary aids and services. Further discussion
of this requirement can be found in our discussion related to the
Notice of Availability (Sec. 92.11).
Comment: Many commenters noted that the parenthetical for sex
discrimination included in proposed Sec. 92.10(a)(1)(i) differs from
the language of Sec. 92.101(a)(2) and that it should be consistent,
such that it should include sexual orientation and gender identity as
well as pregnancy-related conditions.
Response: OCR appreciates the need for consistency across the
regulation, and to ensure that the public is aware of the various bases
for discrimination included under the umbrella of sex discrimination.
As such, OCR has revised the parenthetical in Sec. 92.10(a)(1)(i) to
directly cite to Sec. 92.101(a)(2), rather than listing examples of
discrimination on the basis of sex. This is consistent with edits made
to the Nondiscrimination Policy required by Sec. 92.8(b).
Comment: Various commenters requested that OCR require any entity
receiving a religious exemption to include notice of the exemption in
the Notice of Nondiscrimination; they said it would be misleading to
have a notice stating that the entity does not discriminate if it has
been granted permission to do so in certain circumstances. They stated
that the information is needed for LGBTQI+ persons seeking health care.
Response: OCR appreciates these comments. OCR declines to revise
Sec. 92.10 to impose an affirmative obligation on a recipient to
identify any exemptions it has received under applicable Federal
religious freedom and conscience laws. OCR additionally notes that it
is a best practice for a recipient to include in its Notice of
Nondiscrimination language when it has received a temporary exemption
or an assurance of exemption. OCR is also subject to the Freedom of
Information Act (FOIA), and information may be released to a requestor
or made available for public inspection consistent with the agency's
obligations under that statute and its implementing regulations.
Comment: Several commenters stated that the Notice of
Nondiscrimination should be provided in the same non-English languages
required by Sec. 92.11 (Notice of Availability). Several commenters
urged OCR to create a model Notice of Nondiscrimination, and to issue
translations of this notice.
Response: The Notice of Nondiscrimination is among the materials
that must be accompanied by a Notice of Availability, per Sec.
92.11(c)(5)(i), which must be provided in multiple languages. While we
have declined to require translation of the Notice of Nondiscrimination
into a set number of languages, covered entities may still be required
to provide translations when necessary to ensure meaningful access as
required under Sec. 92.201. OCR will provide a sample Notice of
Nondiscrimination and may provide translations of the sample Notice of
Nondiscrimination.\85\
---------------------------------------------------------------------------
\85\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Translated Resources for Covered Entities, https://www.hhs.gov/civil-rights/for-individuals/section-1557/translated-resources/index.html (translated Notice of Nondiscrimination. Statement of
Nondiscrimination, and Taglines required by the 2016 Rule).
---------------------------------------------------------------------------
Comment: Some commenters argued that the requirement for when and
where the Notice of Nondiscrimination must be provided, Sec.
92.10(a)(2), is too burdensome; others commented that it eases
financial burdens compared to the 2016 Rule requirements, while also
ensuring that people receive information about the covered entities'
civil rights obligations. Some commenters supported the requirement of
prominent posting on websites, including because of the low cost, while
another commenter observed that poor and rural areas sometimes cannot
be reached by internet and described the need to reach historically
underserved and marginalized populations.
Various commenters agreed with the proposal to provide the Notice
of Nondiscrimination annually and upon request as opposed to the 2016
Rule's ``significant communications'' \86\ requirement, including
because the current proposal is clearer than the 2016 Rule requirement.
Others stated that OCR should require the Notice of Nondiscrimination
in all significant communications, such as Explanations of Benefits and
patient intake forms. Some opposed annual notices as costly and
annoying to patients, recommending that notice instead be upon
enrollment, upon request, and prominently in health care plan
documents. Others argued for using the HIPAA model, which requires
notice at first point of service and then upon request only.
---------------------------------------------------------------------------
\86\ 87 FR 47852-53 (discussion in 2022 NPRM); 85 FR 37161-62,
37175 (discussion in 2020 Final Rule).
---------------------------------------------------------------------------
Response: In developing the points of contact at which a Notice of
Nondiscrimination must be provided, OCR considered the concerns raised
by covered entities regarding burden, consumer fatigue, and lack of
clarity and specificity in prior requirements. However, we also
considered comments that stated the Notice of Nondiscrimination is
important to ensure that persons are informed of their civil rights and
without this knowledge, including the right to language assistance
services and effective communication, health disparities may continue
to increase as they did during the COVID-19 pandemic. The provision is
a reasonable and balanced approach that reduces the number of
communications in which this essential notification is required
compared to the 2016 Rule requirements,\87\ while preserving its
necessary function.
---------------------------------------------------------------------------
\87\ Id.
---------------------------------------------------------------------------
While OCR appreciates that many individuals lack internet access,
we note that the regulation as drafted requires posting in physical
locations, as well as being provided upon request, Sec.
92.10(a)(2)(ii) and (iv); therefore, access to the Notice of
Nondiscrimination is not dependent on internet access.
Comment: Various commenters recommended that the Notice of
Nondiscrimination be posted prominently where frontline employees can
see it, and that it be in large sans serif font (at least 18-point
font).
Response: OCR appreciates these comments and the importance of
ensuring that the Notice of Nondiscrimination posted in physical
[[Page 37567]]
locations can be seen and is accessible to individuals who may have low
vision. For this reason, we are finalizing Sec. 92.10(a)(2)(iv) to
require that posted notices be in a sans serif font, no smaller than
20-point font.\88\
---------------------------------------------------------------------------
\88\ See Am. Council of the Blind, Best Practices and Guidelines
for Large Print Documents Used by the Low Vision Community (2011),
https://archive.org/details/bestpracticesgui00coun.
---------------------------------------------------------------------------
Comment: Several commenters argued that the Notice of
Nondiscrimination and Notice of Availability must be provided together,
because they are so intertwined, adding that this may also reduce the
burden for covered entities.
Response: OCR appreciates this comment and directs commenters to
the requirement at Sec. 92.11(c)(5)(i), which requires that the Notice
of Availability be provided with the Notice of Nondiscrimination.
Covered entities may choose to integrate the Notice of Availability
into its Notice of Nondiscrimination.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.10, with modifications. OCR is revising the explanatory
parenthetical for sex at Sec. 92.10(a)(1)(i) to read ``consistent with
the scope of sex discrimination described at Sec. 92.101(a)(2).'' We
are also providing a technical revision to Sec. 92.10(a)(1)(iii) to
replace ``necessary'' with ``a reasonable step'' for consistency with
the standard articulated in Sec. 92.201(a), that ``[a] covered entity
must take reasonable steps to provide meaningful access to each
individual with limited English proficiency (including companions with
limited English proficiency) eligible to be served or likely to be
directly affected by its health programs and activities.'' We are
revising Sec. 92.10(a)(2)(iv) to require that posted notices be
provided ``in no smaller than 20-point sans serif font.'' Finally, we
are making a technical revision to replace ``limited English proficient
individual'' with ``individual with limited English proficiency,''
consistent with modifications elsewhere.
Notice of Availability of Language Assistance Services and Auxiliary
Aids and Services (Sec. 92.11)
In Sec. 92.11, we proposed requiring 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'').
In Sec. 92.11(a), we proposed requiring 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 the 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.
In Sec. 92.11(b), we proposed requiring the Notice of Availability
to be provided in English and at least the 15 most common languages
spoken by individuals with LEP of the relevant State or States, and in
alternate formats for individuals with disabilities who require
auxiliary aids and services to ensure effective communication.
In Sec. 92.11(c), we proposed requiring 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; we also proposed that the notice be provided online (when
applicable) and in a clear and prominent physical location where it is
reasonable to expect individuals seeking services from the health
program or activity to be able to read or hear the notice. In Sec.
92.11(c)(5), we proposed a list of specific electronic and written
communications that the Notice of Availability must accompany. We
invited comment as to whether requiring a Notice of Availability for
all Explanation of Benefit (EOB) documents 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.
In Sec. 92.11(d), we proposed alternative, optional methods by
which a covered entity may be deemed in compliance with proposed Sec.
92.11(a).
We sought 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 for when and where covered
entities must provide the notice. We also invited comment as to whether
the proposed requirements adequately address 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 invited 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 sought comment
on how to best provide the Notice of Availability to individuals with
LEP, including individuals with LEP 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 sought comment on whether the proposed
list of electronic and written communications that the Notice of
Availability must accompany adequately captures the documents for which
individuals with LEP and individuals with disabilities should receive
the Notice of Availability. We further invited comment on the
anticipated costs to covered entities of various sizes to comply with
the proposed requirements.
The comments and our responses regarding Sec. 92.11 are set forth
below.
Comment: Many commenters stated that the Notice of Availability is
needed because people are unaware of their rights to language
assistance and auxiliary aids and services, leaving them unable to
advocate for themselves and leading to health disparities. Commenters
agreed that the 2019 NPRM and 2020 Rule fail to address the costs borne
by participants, beneficiaries, and enrollees in the absence of notice,
and the additional costs to the health care system that could result.
87 FR 47853. Many commenters provided examples of how individuals with
LEP experience disparities in health care, including poor care and
outcomes; higher uninsured status; lower health literacy; longer
hospital stays; greater difficulty understanding health instructions;
and general health care underuse. The commenters emphasized that
providing Notice of Availability is the most essential element to
decreasing language barriers and that with proper notice of their
rights, health disparities for individuals with LEP would be reduced.
Response: OCR appreciates commenters highlighting the importance of
providing individuals with LEP notice of their right to receive
language assistance services, and the negative consequences of failure
to do so. As discussed, OCR considered the concerns raised in response
to the 2019 NPRM and 2020 Rule's failure to include a similar notice
provision, as well as concerns raised in response to the 2016 Rule's
notice provision. As proposed and finalized, Sec. 92.11 provides
[[Page 37568]]
an appropriate balance between the approaches of these prior rules and
is an important tool for combatting and preventing health disparities
based on communication barriers.
Comment: Numerous commenters stated that the requirement to provide
the Notice of Availability in 15 non-English languages was too many,
providing examples of places in which they believe fewer languages were
needed. For example, one provider commented that in California, 95
percent of their communications were requested in the top five
languages in the State, therefore translations into the top five
languages would be sufficient. Other commenters noted that smaller
entities would be particularly burdened by the proposed standards. One
commenter stated that requiring pediatric dental offices to offer the
Notice of Availability as proposed would be burdensome and cause
confusion.
Conversely, many other commenters stated that 15 languages is too
few and that, under the proposed requirements, the Notice of
Availability would not reach enough individuals with LEP, giving
examples of language populations that would not be reached. Some
commenters expressed a belief that covered entities should ensure each
individual with LEP receives information about their rights in their
preferred language, and that a 15-language requirement would not
adequately provide that assurance. Some commenters stated that the
identification of languages required should not be determined at the
State level but should instead be based on the covered entity's entire
program area in various states. On the other hand, some commenters
expressed that the required languages should always be determined at
the State level only, rather than ``State or States.''
Commenters said that because OCR will provide model notices
translated into the required languages, and because of the need for
meaningful notice of auxiliary aids and language assistance services,
the burden for providing notices in the top 15 languages per State is
lessened and reasonable. A few local government commenters stated that
their jurisdiction currently requires translation in more than 100
languages and recommended that this rule incorporate State and local
norms.
Response: In determining the formula for the Notice of Availability
translation requirement, OCR considered the 2016 Rule requirement,
evaluated national- and State-level language proficiency data issued by
the U.S. Census Bureau (Census), as well as potential the costs and
burdens for covered entities.
The need to provide individuals with LEP notice of the availability
of language assistance services remains clear and there is ample
evidence that failure to provide meaningful language access in a health
care setting can lead to higher costs to the health care system and
have grave consequences to individuals with LEP. 87 FR 47853-54. Since
the ACA was enacted, the percentage of the U.S. population with LEP
(defined as those who speak English less than ``very well,'' as
collected by the Census) has remained at roughly 10 percent.\89\
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\89\ U.S. Bureau of Census, Sandy Dietrich & Erik Hernandez,
Language Use In the United States: 2019, Am. Community Survey
Reports, p. 4 (2022), https://www.census.gov/content/dam/Census/library/publications/2022/acs/acs-50.pdf.
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OCR has received complaints and entities have sued the Department
for rescinding the 2016 Rule's notice requirements.\90\ Litigants in
Chinatown Services Center v. U.S. Department of Health & Human Services
raised specific concerns that older members of the Asian American,
Native Hawaiian, and Pacific Islander community, who have high rates of
limited English proficiency, experienced disparities because they are
not aware of their right to receive language assistance services or how
to raise a concern when such services are not provided.\91\ Although
one Federal court ultimately held that a plaintiff health system was
not likely to prevail on the merits of its Administrative Procedure Act
challenge to the 2020 Rule's repeal of the 2016 Rule's notice
requirements, the court notably acknowledged that a consequence of the
2020 Rule was that the plaintiff health system provided ``costlier and
more difficult treatment'' because patients with LEP likely received
inadequate health care elsewhere and arrived to their system sicker
than they otherwise may have.\92\
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\90\ See Compl., Chinatown Serv. Ctr. v. U.S. Dep't of Health &
Hum. Servs., No. 1:21-cv-00331 (D.D.C. Feb. 25, 2021), Compl.,
Whitman-Walker Clinic v. U.S. Dep't of Health Hum. Servs., No. 1:20-
cv-01630 (D.D.C. June 22, 2020) and see 87 FR 47853-54.
\91\ Compl., Chinatown Serv. Ctr. v. U.S. Dep't of Health & Hum.
Servs., No. 1:21-cv-00331, 22-35 (D.D.C. Feb. 25, 2021).
\92\ Whitman-Walker Clinic v. U.S. Dep't of Health & Hum.
Servs., 485 F. Supp. 3d 1, 30 (D.D.C. 2020).
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OCR appreciates concerns regarding proposed Sec. 92.11, which
would require a covered entity operating in all 50 States to aggregate
the populations with LEP across those States to determine the top 15
languages spoken by individuals with LEP in its service area. While
this may result in a failure to reach some in-State LEP populations due
to geographical variances, no single formula, including a State-level
formula, will cover all individuals with LEP. However, this formula
would cover a significant majority (over 93 percent) of individuals
with LEP, even for covered entities that operate on a national
level.\93\
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\93\ U.S. Census Bureau, Am. Community Survey 5-Year Estimates
Public Use Microdata Sample 2020 for the 50 States and DC (2000),
ACS 5-Year Estimates Public Use Microdata Sample 50 States & DC;
https://data.census.gov/mdat/#/search?ds=ACSPUMS5Y2020&cv=ENG&rv=ucgid,LANP&wt=PWGTP&g=0400000US01,02,04,05,06,08,09,10,11,12,13,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,44,45,46,47,48,49,50,51,53,54,55,56.
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Thus, while OCR appreciates the request to increase the number of
languages into which the Notice of Availability must be translated, we
have determined that this would likely increase burdens while yielding
additional coverage of marginally few individuals with LEP. However,
covered entities are reminded that they must still take reasonable
steps to provide meaningful access to all individuals with LEP,
regardless of whether the individual's primary language is one of the
15 most frequently spoken non-English languages in their State or
States, per Sec. 92.201. Further, nothing in this rule prevents
jurisdictions from requiring that the Notice of Availability be
translated into more languages; covered entities wishing to provide
more languages may also do so.
OCR recognizes concerns raised in the comments regarding the
potential cost of translating the Notice of Availability into the
required languages. To offset this concern, OCR has provided
translations of the model Notice of Availability in the top 15
languages in each State, at www.hhs.gov/1557. Additionally, Sec.
92.11(c) reduces the number of documents for which provision of the
translated notices is required from the 2016 Rule, and Sec. 92.11(d)
provides two options for how a covered entity may otherwise meet the
requirements of this provision. OCR anticipates that efficiencies
created by this formula--complemented by the availability of OCR-
translated Notices of Availability--will benefit covered entities and
the communities they serve. These benefits will reduce harmful impacts
of the failure to take reasonable steps to provide meaningful access--
such as unnecessary hospital readmissions, lower rates of outpatient
follow up, limited use of preventive services, poor medication
adherence, and lack of understanding of discharge
[[Page 37569]]
instructions \94\--thereby alleviating burdens on community
organizations that have been providing notice of language access as
well as providers who have seen negative impacts such as increased
costs and sicker patients since the repeal of the 2016 Rule's notice
requirements. See 87 FR 47853-54. Given these efforts, the requirement
of providing notice of language access rights is not overly burdensome
when balanced with the need to provide notice of the availability of
language assistance services to individuals with LEP.
---------------------------------------------------------------------------
\94\ See Neelam H. Ahmed et al., Moderation of the Association
Between Primary Language and Health by Race and Gender: An
Intersectional Approach, 19 Int. J. Environ. Rsch. Pub. Health 7750
(2022), https://www.mdpi.com/1660-4601/19/13/7750.
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Comment: A few commenters suggested that a hybrid method should be
used to calculate which languages are required for translation under
this provision, such as the higher or lower of a percentage or absolute
number (for example, a threshold of five percent or 1,000 individuals
with LEP, whichever is lower). Some commenters recommended OCR adopt
the standard found in Tri-Departmental regulations at 26 CFR 54.9815-
2719(e), 29 CFR 2590.715-2719(e), and 45 CFR 147.136(e), which applies
a county-level formula and is applicable to the internal claims and
appeals and external review processes for group health plans and health
insurance issuers in the group and individual health insurance markets,
to decrease costs and avoid confusion. Some added that a hybrid method,
such as allowing for calculations at the county- instead of State-
level, is especially critical for small practices operating at only the
county level. They stated these practices may not have resources to
translate the Notice of Availability into the top 15 languages spoken
in the State and may serve language communities that are different from
those represented by the top 15 languages at the State-level.
Response: OCR appreciates these suggestions but, as we discussed in
the Proposed Rule, OCR declined to adopt a population threshold due to
variances among urban and rural communities. 87 FR 47855. We are
concerned about similar results if a percentage threshold is used, and
we decline to adopt this approach.
While OCR appreciates that some covered entities will have to
comply with both OCR and Tri-Departmental regulations, we decline to
adopt the county-level formula found in the referenced Tri-Departmental
regulations, 26 CFR 54.9815-2719(e), 29 CFR 2590.715-2719(e), and 45
CFR 147.136(e), which provides that a non-English language is an
applicable non-English language if ten percent or more of the
population residing in the county is literate only in the same non-
English language, as section 1557 applies to a wider range of covered
entities, communications, and individuals with LEP. We will continue to
monitor issues related to this area and work with CMS as appropriate in
the future to ensure compliance.
Comment: Some commenters suggested that OCR work with covered
entities and community groups to develop additional effective ways to
inform individuals with LEP about their language access rights. A
health insurance entity suggested convening a stakeholder process to
develop and test a pilot with easy-to-understand, universal language
access symbols to connect persons with LEP to language assistance
services.
Response: OCR appreciates this recommendation and welcomes the
opportunity to collaborate with covered entities and community groups
to develop effective means for informing individuals with LEP of their
language access rights.
Comment: Many commenters supported the list of documents requiring
a Notice of Availability in Sec. 92.11(c), emphasizing the critical
importance of clear communications in health care settings. Some
commenters noted the provision fills information gaps and that
receiving information multiple times is sometimes needed for effective
notice, particularly for older adults. Others expressed support for the
balanced approach of including opt-out provisions so that covered
entities are not overly burdened, but participants and beneficiaries
know their rights. Several commenters urged OCR to add medical bills to
the list, providing examples of negative impacts of bills being sent
without notice of how to access effective communication.
Many other commenters expressed concerns about administrative
burdens and costs of notice in relation to the number of communications
in which the Notice of Availability would be required under Sec.
92.11(c), while others pointed out that the list is effectively shorter
than in the past.
Several commenters wrote generally about language assistance
services and auxiliary aids and services, with some asking for
flexibility in the language access rules to allow for translation of
the most important documents with the provision of oral interpretation
for other information. Another argued that translation and
interpretation as well as auxiliary aids and services rules should not
apply to physician practices or health centers. Others requested that
health insurance issuers or the Federal Government reimburse providers
for disseminating these items.
Response: We appreciate the comments and believe that the list of
documents identified in Sec. 92.11(c), which provides clarity and
prioritizes inclusion of the Notice of Availability in critical health
care documents, strikes the appropriate balance between potential
burdens to covered entities and the benefits to individuals with LEP
and individuals with disabilities. OCR appreciates commenters raising
concerns regarding the accessibility of medical billing, which can have
long-term negative financial impacts on patients.\95\ Similarly,
accessible notices of expected costs and benefits, such as the good
faith estimate, can help patients make informed, cost-conscious
decisions about their care and reduce the risk of unexpected medical
bills.\96\ The potential financial impact of making these estimates
accessible is particularly significant for individuals with LEP and
individuals with disabilities who are uninsured (or self-pay), because
these individuals have the right to dispute medical bills that are
substantially in excess of the expected charges on their good faith
estimate \97\ and exercise of this right depends on the ability of such
individuals to understand both their good faith estimates and their
medical bills. For these reasons, we are adding Sec. 92.11(c)(5)(ix),
which requires a covered entity to provide its Notice of Availability
along with billing-related documents and reads: ``Communications
related to the cost and payment of care with respect to an individual,
including medical billing and collections materials, and good faith
estimates required by section 2799B-6 of the Public Health Service
Act.''
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\95\ See NPR, Lauren Weber & Hannah Recht, Medical Bills Remain
Inaccessible for Many Visually Impaired Americans, Health, Inc.
(Dec. 1, 2022), https://www.npr.org/sections/health-shots/2022/12/01/1139730806/blind-disability-accessibility-medical-bills
(discussing an investigative news report and including an OCR
investigation).
\96\ Internal Revenue Code section 9816(f), ERISA section
716(f), and PHS Act section 2799A-1(f), as added by section 111 of
title I of division BB of the Consolidated Appropriations Act, 2021
(CAA); PHS Act section 2799B-7, as added by section 112 of title I
of division BB of the CAA; 45 CFR 149.610.
\97\ PHS Act section 2799B-6, as added by section 112 of title I
of division BB of the CAA; 45 CFR 149.620.
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Comment: Regarding an alternative, optional means of compliance at
Sec. 92.11(d), one covered entity commenter requested that OCR specify
that entities in compliance with other
[[Page 37570]]
Department requirements related to language access and auxiliary aids
are deemed to have complied with section 1557. One commenter stated
that the Notice of Availability should be combined with the Notice of
Nondiscrimination, as well as HIPAA notices; another suggested OCR work
with CMS and other HHS agencies to leverage existing practices and make
these requirements technically operational.
Response: As discussed elsewhere, OCR appreciates that covered
entities may have compliance requirements under other Department
regulations similar to those found in this provision. However, given
the range of health programs and activities to which section 1557 and
the part apply--including those where inaccessible communication can
have life-or-death consequences--it is imperative to have an
independent requirement. Covered entities' compliance with Sec.
92.11(b) will increase the likelihood of compliance with similar
Department translation requirements. While we appreciate commenters'
suggestion to combine the Notice of Availability with the Notice of
Nondiscrimination and the HIPAA notices, Sec. 92.11(c)(5) requires the
Notice of Availability to additionally be included with a list of
important health care documents because the ability of patients to
avail themselves of language access services is foundational to
improving health outcomes for individuals with LEP. OCR will therefore
maintain this requirement under Sec. 92.11(c)(5) for covered entities.
Comment: Various commenters expressed support for the alternate
compliance provisions found in Sec. 92.11(d). One group raised the
idea of an ``opt-in'' provision, in which individuals with LEP would
have to state that they want Notice of Availability, in lieu of the
proposed opt-out provision, and sought clarification about whether the
opt-out provision can be combined with Notice of Availability.
Some commenters argued that the alternate compliance options could
be difficult to implement and lead to additional costs, cause
confusion, or be generally burdensome, with one commenter stating they
would be more burdensome than the 2016 Rule requirements because they
require customizing documents. One commenter requested OCR delay
implementation of the opt-out provision until 2024; other commenters
suggested replacing the option with a less burdensome approach, asking
that it be only electronic.
On the other hand, commenters stated that the opt-out provision
strikes a reasonable balance that is effectively narrower than the 2016
Rule's ``significant communications'' requirement. Another commenter
agreed, commenting that the proposal could be both more consumer
friendly and helpful, as well as less duplicative and costly than the
2016 Rule. One commenter encouraged OCR to provide robust oversight of
opt-out processes in order to protect civil rights.
Response: OCR appreciates the range of comments received on this
new provision. We emphasize that the options included in Sec. 92.11(d)
are options, and not requirements. Thus, we appreciate that covered
entities may wish to have a delayed applicability date, to pursue these
options only through electronic means, or not pursue them at all. OCR
is not requiring any actions under Sec. 92.11(d) be taken; rather, OCR
is providing alternate means to satisfy the requirements of Sec. 92.11
without including the full Notice of Availability with all
communications listed at Sec. 92.11(c).
OCR declines to make further changes clarifying that a person
should only be asked about their language needs once, because Sec.
92.11(d)(1) permits this if the individual exercises the option to opt-
out. Moreover, Sec. 92.11(d)(2) allows a covered entity to document an
individual's primary language, any appropriate auxiliary aids and
services, and to communicate with them in that manner.
OCR intends to provide robust review of opt-outs, as well as
technical assistance, to ensure that covered entities that choose to
exercise this option do so in a manner consistent with the requirements
at Sec. 92.11(d).
Comment: Many commenters submitted recommendations to increase
guarantees of accessibility of the Notice of Availability for
individuals with disabilities, such as requiring that: (1) notices be
provided in large sans serif print, at a minimum of 18-point font; (2)
notices be on the first page or otherwise at the beginning of documents
or publications; (3) the needs of persons who are illiterate be taken
into account through provision of audio or video notices; (4) all
written notices be in plain language (fourth grade reading level),
accompanied by visual aids when practicable; and (5) notice should be
provided via audio, video, and American Sign Language. A coalition also
discussed recommendations to ensure effective communication. Other
accommodations recommended included: (1) screen readers and audio/video
accessibility; (2) alternatives to braille (e.g., large print,
qualified reader) because braille may not be economically feasible for
all entities; (3) accessible tagline requirements or cross-references
to language access rights; and (4) ``Easy Read'' text, images, brief
sentences, large and simple fonts, and location on the first page.
Many also commented that the Notice of Availability should be
posted where frontline employees can readily see it, that employees
should be trained to provide it, and that it be available upon request.
Various commenters urged that covered entities must proactively ask
people if they have communications barriers. Further, commenters stated
that primary consideration should be given to what a person with a
disability asks for in terms of auxiliary aids or services. Another
commenter added that provision of the notice should be clarified so it
applies to listening devices and the other range of auxiliary aids.
Response: OCR appreciates all the suggestions and reminds
commenters and others that the meaningful access and effective
communication requirements (Sec. Sec. 92.201 and 92.202, respectively)
regarding the provision of language access and auxiliary aids apply to
the Notice of Availability. Covered entities have existing effective
communication obligations under section 504 and section 1557, which may
include providing the notice in an alternate format or providing
another auxiliary aid or service. Thus, if an individual is in need of
the notice in an alternate format or through another auxiliary aid or
service, that would likely already be required when it is necessary to
ensure effective communication. We decline to affirmatively require the
notice be provided in any additional formats at this time. However, OCR
agrees that larger print should be required to ensure the accessibility
of the Notice of Availability when posted in physical locations, and
that this requirement is relatively straightforward to implement;
accordingly, Sec. 92.11(c)(4) has been amended to require print no
smaller than 20-point in a sans serif font.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.11, with modifications. We are revising Sec. 92.11(b) to
clarify the relevant State or States are those ``in which a covered
entity operates.'' We are modifying Sec. 92.11(c)(4) to clarify that
posted notices be provided ``in no smaller than 20-point sans serif
font.'' We are adding
[[Page 37571]]
Sec. 92.11(c)(5)(ix) to read: ``Communications related to the cost and
payment of care with respect to an individual, including medical
billing and collections materials, and good faith estimates required by
section 2799B-6 of the Public Health Service Act.'' We are also making
technical revisions, including replacing ``limited English proficient
individual'' with ``individual with limited English proficiency,''
consistent with modifications elsewhere.
Data Collection
We solicited comments on requiring 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, to inform a final
rule and OCR's overall civil rights work.
We also sought comment on 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 invited comment on how a section
1557 civil rights data collection requirement could impact current data
collection efforts, either positively or negatively. We also requested
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 sought 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, providers, health care facilities
and clinics, hospitals, Federally Qualified Health Centers, and health-
related educational and training programs. Accordingly, we invited
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, whether that exemption should 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.
The comments and our responses regarding data collection are set
forth below.
Comment: Some commenters recommended that OCR not mandate the
collection of data, with some strongly suggesting that we minimize
provider burden and utilize existing data collection systems.
Response: OCR is not including a data collection requirement in the
final rule. OCR has the authority independent of this rulemaking to
conduct data calls to ensure recipient compliance with Federal civil
rights laws.\98\ OCR is actively engaged with other agencies within the
Department and throughout the Federal Government related to responsible
data collection and recognizes the importance of data collection to
meet its mission. We will continue to work with covered entities and
beneficiaries to determine whether an additional data collection
requirement is needed in a future rulemaking.
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\98\ See, e.g., 45 CFR 80.6(b).
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Comment: Some commenters recommended that OCR adopt data collection
standards. They noted that with any demographic data collection
requirement, OCR must provide appropriate training and technical
assistance resources to programs and grantees and make clear that data
cannot be used for negative actions such as immigration or law
enforcement, redlining, or targeting of specific groups.
Response: OCR appreciates the comments regarding standards and
safeguards to ensure that programs and grantees have the appropriate
training. OCR also understands the concerns that some commenters have
regarding data being used for adverse actions. While OCR is not
including a data collection requirement in the final rule, OCR will
continue to research the benefits of civil rights data collection and
how to mitigate potential negative impacts.
Comment: Some commenters urged OCR to require covered entities to
collect data regarding a core set of disaggregated categories to
include race, ethnicity, language, sex, gender, gender identity, sexual
orientation, pregnancy status, sex characteristics, disability, and age
from patients and providers. Commenters stated that data are essential
to identify and address unmet needs, and for many populations data
remain largely uncollected. Some commenters also noted that collecting
disaggregated data could allow OCR to distinguish the impact of
intersectional discrimination on those seeking access to health care.
Some commenters also urged that if individuals volunteer such
information, it should be self-reported to ensure accuracy and privacy.
Response: OCR agrees that better standards and practices for
collecting data can have a positive impact on reducing disparities. OCR
will continue to work to ensure that any civil rights data collection
yields accurate data that adequately protects the privacy of
individuals.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing the rule without a data collection
provision.
Subpart B--Nondiscrimination Provisions
In subpart B, OCR proposed provisions related to the prohibition of
discrimination on the basis of race, color, national origin, sex, age,
and disability in covered health programs and activities.
Discrimination Prohibited (Sec. 92.101)
In Sec. 92.101(a), we proposed 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 the part applies and provided additional detail regarding what
constitutes discrimination on the basis of sex.
In Sec. 92.101(a)(1), we proposed general prohibitions on
discrimination under section 1557 by restating the core objective of
section 1557. In Sec. 92.101(a)(2), we clarified 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.
In Sec. 92.101(b), we identified several specific forms of
prohibited discrimination under section 1557. Proposed Sec.
92.101(b)(1)(i) specifically referred to recipients of Federal
financial assistance and State Exchanges; proposed Sec.
92.101(b)(1)(ii) referred to the Department's health programs and
activities, including Federally-facilitated Exchanges.
In Sec. 92.101(b)(2), we proposed that the enumeration of specific
forms of discrimination in 92.101(b) does not limit the general
application of the prohibition in proposed Sec. 92.101(a).
The comments and our responses regarding Sec. 92.101 are set forth
below.
Comment: Numerous commenters supported the Proposed Rule's
nondiscrimination provisions, stating that these provisions would
promote the health equity for communities of color and increase access
to coverage and care for those who have been historically underserved
because of race, ethnicity, language, age, disability, and sex. Many
commenters stated that OCR should finalize the provisions without
delay.
[[Page 37572]]
Another commenter supported the proposed discrimination prohibitions as
consistent with the ACA, and another requested that more support be
provided for educating the public about the nondiscrimination
obligations of health programs and activities.
Response: OCR agrees that the nondiscrimination provisions are one
important tool to address health disparities and advance health equity.
OCR will continue to provide technical assistance and public education
related to compliance with section 1557 and encourages covered entities
to continue to visit our website for technical assistance materials.
Comment: Numerous commenters stated that section 1557's explicit
prohibition on discrimination based on multiple grounds fills a
critical gap by protecting patients who may experience multiple forms
of discrimination. Commenters provided numerous examples of
simultaneous discrimination on more than one protected basis,
including, but not limited to, discrimination against LGBTQI+
individuals of color, with disabilities, with LEP, or who are
immigrants; and Black and Hispanic/Latino older adults. Numerous
commenters recommended that OCR revise Sec. 92.101(a)(1) to include
``or any combination thereof'' to explicitly account for intersectional
discrimination within the regulatory text.
Response: OCR agrees that simultaneous discrimination on multiple
prohibited bases, is important to account for and is prohibited by
section 1557. As we noted in the Proposed Rule, a recent study examined
disability and pregnancy as intersecting traits and how this may impact
risk for maternal morbidity and mortality, underscoring the importance
of ensuring nondiscrimination against women with disabilities. 87 FR
47837. The Proposed Rule also provided information regarding Black
maternal health and the alarming disparities in maternal mortality
rates for Black women and American Indian/Alaska Native women. 87 FR
47832.
Therefore, to account for the fact that individuals can experience
discrimination based on two or more protected bases (race, color,
national origin, sex, age, and disability), we have amended the
language of Sec. 92.101(a)(1) to include ``or any combination
thereof.'' This language has also been amended throughout the final
rule for consistency. The addition intends to clarify that an
individual is protected from discrimination on more than one protected
basis that occurs at the same time.
Comment: A commenter provided a discussion of the harms and
unaddressed discrimination faced by patients with rare diseases and
requested that OCR explicitly prohibit discrimination against patients
with rare diseases. Some commenters requested that specific recognition
also be made for patients with liver diseases. A commenter requested
that the proposed regulatory text or accompanying guidance provide
examples of discrimination on the basis of disability.
Response: Discrimination against an individual with a rare or
specific disease that meets the definition of ``disability'' will be
addressed under section 1557's prohibition on discrimination on the
basis of disability, which already appears in the rule. The commenter's
request for further guidance will be taken into consideration. For
additional information related to disability discrimination, please see
the discussions under subpart C. OCR also provides guidance and
examples, as well as answers to frequently asked questions related to
disability discrimination on our website.
Comment: A number of commenters asked that vaccination status be
added as a ground of prohibited discrimination, stating that their
right to make their own health care decisions should be protected.
Response: Section 1557 prohibits discrimination on the basis of
race, color, national origin, sex, age, and disability. To the extent
vaccination status is not related to these prohibited bases of
discrimination specified by Congress in section 1557, we decline to
include it as a ground of prohibited discrimination under this rule.
Comment: Some tribal organizations recommended that OCR acknowledge
American Indian/Alaska Native (AI/AN) people as holding a political
classification as compared to a race-based classification and to exempt
Tribal health programs from the final rule. These commenters stated
that recognizing the political classification of AI/AN people allows
AI/AN providers to only serve AI/AN patients, which commenters said is
necessary because of logistical capacity constraints.
Response: As discussed at Sec. 92.2, OCR recognizes the unique
relationship between the United States and federally recognized tribal
entities. Federal Government preferences based on an individual's
membership or eligibility in a federally recognized tribal entity are
based on political classifications. Such classifications are not race-
based. As such, preferences on this basis do not violate the Equal
Protection Clause,\99\ title VI,\100\ or section 1557. As discussed at
Sec. 92.2, preferences based on the unique relationship between the
United States and federally recognized Tribes are distinct from the
protections afforded under Federal civil rights laws, which protect all
individuals from discrimination on the basis of race, color, or
national origin (including AI/AN individuals, regardless of tribal
enrollment or affiliation). This final rule adopts by reference the
Department's title VI regulatory provision at 45 CFR 80.3(d), which
provides that an individual shall not be deemed subjected to
discrimination by reason of their exclusion from benefits limited by
Federal law--such as the Indian Health Service--to individuals of a
different race, color, or national origin. OCR will fully apply this
provision as well as other applicable exemptions or defenses that may
exist under Federal law. OCR intends to address any restrictions on
application of section 1557 to Tribal entities in the context of
individual complaints or compliance reviews.
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\99\ See Morton v. Mancari, 417 U.S. 535 (1974).
\100\ 45 CFR 80.3(d).
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Comment: A commenter suggested that nondiscrimination protections
should be extended to health care workers, indicating that health care
workers often experience discrimination, especially on the basis of
race and that additional protections are needed.
Response: While OCR acknowledges that health care workers can face
discrimination as they provide health care, OCR does not have
jurisdiction over patients who may discriminate against health care
workers, as patients are not covered entities under section 1557.
Separately, and as previously noted, OCR does not intend for this rule
to apply to employment discrimination. If OCR receives a complaint from
a health care worker, we will determine if we have jurisdiction to
investigate. Complaints received by OCR from health care workers
alleging discrimination experienced in the context of employment will
be referred to an appropriate agency, per Sec. Sec. 92.303(b) and
92.304(a) (incorporating 45 CFR 85.61(e)), as this regulation does not
apply to employment practices.
Comment: Many commenters expressed support for the explicit
references to discrimination on the basis of sex stereotypes; sex
characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; and gender identity as forms of
[[Page 37573]]
discrimination on the basis of sex in Sec. 92.101(a)(2). Commenters
pointed to evidence of health disparities and barriers to accessing
health care faced by LGBTQI+ people, and how ongoing health care
discrimination contributes to higher rates of substance use, mental
health conditions, HIV, cancer, and cardiovascular disease for LGBTQI+
people relative to non-LGBTQI+ people.\101\ Several commenters stated
that Sec. 92.101(a)(2)'s prohibitions should be mirrored in the CMS
regulations addressed in section IV.
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\101\ See, e.g., Charlotte Patterson et al., Nat'l Acads. of
Sci., Eng'g, & Med., Understanding the Well-Being of LGBTQI+
Populations (2020), https://doi.org/10.17226/25877; Lambda Legal,
When Health Care Isn't Caring: Lambda Legal's Survey of
Discrimination Against LGBT People and People with HIV (2010),
www.lambdalegal.org/health-care-report; Cornell Univ., What Does the
Scholarly Research Say about the Effects of Discrimination on the
Health of LGBT People? (2019), https://whatweknow.inequality.cornell.edu/topics/lgbt-equality/what-does-scholarly-research-say-about-the-effects-of-discrimination-on-the-health-of-lgbt-people/.
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Response: It is well documented that LGBTQI+ people face
significant health disparities and barriers to health care and
insurance coverage,\102\ and section 1557's protections are critical
tools to combat those disparities. We appreciate commenters' view that
CMS regulations within this rulemaking should mirror the language
provided in Sec. 92.101(a)(2), and we refer readers to section IV (CMS
Amendments).
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\102\ See, e.g., 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/; 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. See also
Caroline Medina et al., Ctr. For Am. Progress, Discrimination and
Barriers to Well-Being: The State of the LGBTQI+ Community in 2022
(2023), https://www.americanprogress.org/article/discrimination-and-barriers-to-well-being-the-state-of-the-lgbtqi-community-in-2022/.
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Comment: A number of comments addressed discrimination in the
context of organ transplantation. Several commenters noted that people
with disabilities are routinely denied access to organ transplants due
to stereotypical assumptions about compliance with post-operative care
and policies that deny transplants to otherwise eligible individuals
with disabilities.\103\
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\103\ See Nat'l Council on Disability, Organ Transplant
Discrimination Against People with Disabilities (2019), https://www.ncd.gov/assets/uploads/reports/2019/ncd_organ_transplant_508.pdf.
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Several commenters noted that existing practices in organ
transplants appear to discriminate against Black, Hispanic/Latino, and
Native American/Alaska Native individuals, as those individuals are
more likely to develop end stage renal disease but are less likely to
receive a kidney transplant than white individuals.\104\ Another
commenter stated that providers may discriminate against immigrant
patients during the assessment process by assuming they lack social
support or the ability to care for themselves after organ
transplantation, resulting in a denial of care.\105\
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\104\ See U.S. Renal Data System, 2021 Annual Report: End Stage
Renal Disease ch. 1 (2021) (Figure 1.8); Hannah Wesselman et al.,
Social Determinants of Health and Race Disparities in Kidney
Transplant, 16 Clin. J. Am. Soc'y Nephrol. 262, 262 (2021).
\105\ See Garyphallia Poulakou, Oscar Len & Murat Akova,
Immigrants as Donors and Transplant Recipients: Specific
Considerations, 45 Int. Care Med. 401 (2019), https://pubmed.ncbi.nlm.nih.gov/30701293/.
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Response: Discrimination on the basis of disability and race in the
provision of health care, including organ transplantation, is a
continuing issue that limits opportunities for life-saving treatment.
This final rule provides OCR with a powerful tool to help address this
ongoing issue. While section 1557 does not prohibit discrimination on
the basis of immigration status, section 1557's protections apply
regardless of someone's citizenship or immigration status, and
individuals who believe they have been discriminated against based on
certain characteristics such as race, color, and national origin can
file a complaint. We will continue to address discrimination in organ
transplantation through robust enforcement of not only section 1557,
but all Federal civil rights laws.\106\
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\106\ See, e.g., U.S. Dep't Health & Hum. Servs., Off. for Civil
Rts., OCR Resolves Disability Complaint of Individual Who Was Denied
the Opportunity for Health Transplant List Placement (Feb. 12,
2019), https://www.hhs.gov/about/news/2019/02/12/ocr-resolves-disability-complaint-individual-who-was-denied-opportunity-heart-transplant-list.html.
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Comment: Numerous commenters generally supported the inclusion of
the prohibition of discrimination on the basis of gender identity and
sexual orientation as prohibited types of sex discrimination in
proposed Sec. 92.101(a)(2). They maintained that inclusion was
consistent with Bostock v. Clayton County, 590 U.S. 644 (2020), in
which the Supreme Court held that title VII's prohibition of
discrimination because of sex includes discrimination on the basis of
sexual orientation and gender identity. Commenters supported the
application of the reasoning in Bostock to title IX by citing several
cases, DOJ resource materials, and Executive Order (E.O.) 13988.\107\
Another commenter cited several cases stating that courts have treated
title VII and title IX protections as consistent with one another in
support of the application of Bostock to title IX.\108\ A few
commenters cited City of Los Angeles Department of Water and Power v.
Manhart, 435 U.S. 702 (1978), as indicating that, for decades, sex
discrimination prohibitions have covered sex stereotypes. The
commenters also cited several opinions from district courts and one
appellate court as indicating that discrimination on the basis of
gender identity, gender transition, sex stereotypes, or transgender
status are, similarly, unlawful types of sex discrimination.\109\ Other
commenters provided cites to numerous other cases as including gender
identity and sexual orientation as characteristics protected by sex
discrimination law.\110\
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\107\ E.O. 13988, 86 FR 7023 (Jan. 25, 2021). U.S. Dep't of
Justice, Title IX Legal Manual, https://www.justice.gov/crt/title-ix. See, e.g., Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d 586,
616-17 (4th Cir. 2020), as amended (Aug. 28, 2020), reh'g en banc
denied, 976 F. 3d 399 (4th Cir. 2020), cert. denied, No. 20-1163
(June 28, 2021); 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); 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).
\108\ See, e.g., Doe v. Snyder, 28 F.4th 103, 113-14 (9th Cir.
2022); Emeldi v. Univ. of Or., 698 F.3d 715, 725 (9th Cir. 2012);
Franklin v. Gwinnett Cnty. Pub. Sch., 503 U.S. 60, 75 (1992); Grimm
v. Gloucester Cnty. Sch. Bd., 972 F.3d 586, 616 (4th Cir. 2020).
\109\ See Kadel v. Folwell, 620 F. Supp. 3d 339, 379 (M.D.N.C.
2022); Fain v. Crouch, 618 F .Supp. 3d 313, 326-27 (S.D.W. Va.
2022); Fletcher v. Alaska, 443 F. Supp. 3d 1024, 1027, 1030 (D.
Alaska 2020); Flack v. Wisconsin Dep't of Health Servs., 395 F.
Supp. 3d 1001, 1019-22 (W.D. Wis. 2019); Boyden v. Conlin, 341 F.
Supp. 3d 979, 1002-03 (W.D. Wis. 2018); Cf. Brandt by & through
Brandt v. Rutledge, 2022 WL 3652745, at *2 (8th Cir. Aug. 25, 2022).
\110\ See, among others cited, Grimm v. Gloucester Cnty. Sch.
Bd., 972 F.3d 586, 593, 616, 619 (4th Cir. 2020), reh'g en banc
denied, 976 F.3d 399 (4th Cir. 2020); Whitaker v. Kenosha Unified
Sch. Dist. No. 1 Bd. of Educ., 858 F.3d 1034, 1049-50 (7th Cir.
2017); Fain v. Crouch, No. 3:20-0740, 2022 U.S. Dist. LEXIS 137084,
at *35-36 (S.D. W. Va. Aug. 2, 2022); Scott v. St. Louis Univ.
Hosp., No. 4:21-cv-01270-AGF, 2022 U.S. Dist. LEXIS 74691, at *18
(E.D. Mo. Apr. 25, 2022); C.P. v. Blue Cross Blue Shield of Ill.,
536 F. Supp. 3d 791, 793 (W.D. Wash. 2021); Flack v. Wis. Dep't of
Health Servs., 395 F. Supp. 3d 1001, 1014-15 (W.D. Wis. 2019);
Boyden v. Conlin, 341 F. Supp. 3d 979, 997, 1002-03 (W.D. Wis.
2018); Tovar v. Essentia Health, 342 F. Supp. 3d 947, 953 (D. Minn.
2018); Prescott v. Rady Children's Hosp.-San Diego, 265 F. Supp. 3d
1090, 1098-1100 (S.D. Cal. 2017); Adams v. Sch. Bd. of St. Johns
Cnty., 968 F.3d 1286, 1305 (11th Cir. 2020); Zarda v. Altitude
Express, Inc., 883 F.3d 100, 112-13 (2nd Cir. 2018); Franchina v.
Providence, 881 F.3d 32, 53-54 (1st Cir. 2018); Hively v. Ivy Tech,
853 F.3d 339, 340-41 (7th Cir. 2017).
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Conversely, several commenters stated that Bostock does not support
Sec. 92.101(a)(2) as written. Some commenters stated that Bostock
defined sex to include only ``biological distinctions between male and
female'' and used the term ``transgender status''
[[Page 37574]]
rather than ``gender identity.'' A commenter argued that title VII
should be treated as distinct from title IX because title IX uses the
term ``on the basis of sex''--language the commenter described as
requiring more than ``but for causation''--while title VII uses
``because of . . . sex.'' Other commenters discussed title IX to
support arguments that discrimination on the basis of sex does not
include discrimination on the basis of sexual orientation or gender
identity, and that title IX only protects people on the basis of
``biological sex.''
Some commenters cited to various cases in opposition to the
inclusion of gender identity and sexual orientation in proposed Sec.
92.101(a)(2), including State of Tennessee v. Department of Education,
615 F. Supp. 3d 807 (E.D. Tenn. 2022), to support the belief that
agencies cannot rely on the reasoning in Bostock to interpret what
constitutes sex discrimination under title IX. Another commenter stated
that E.O. 13988 improperly expands the application of Bostock and cited
Franciscan Alliance v. Burwell, 227 F. Supp. 3d 660 (N.D. Tex. 2016) in
support. Some commenters stated that RFRA's religious protections may
supersede the sex discrimination protections described in Bostock, and
one commenter cited Hosanna-Tabor Evangelical Lutheran Church and
School v. EEOC, 565 U.S. 171 (2012), for the proposition that that
First Amendment protections may supersede employment discrimination
laws. Another commenter stated that OCR's interpretation of what is
prohibited sex discrimination is contrary to law, citing to Franciscan
Alliance, Inc. v. Becerra \111\ and Christian Employers Alliance v.
EEOC.\112\
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\111\ 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
docketed, No. 21-11174 (5th Cir. Nov. 26, 2021); see also Franciscan
All., Inc. v. Becerra, 47 F.4th 368 (5th Cir. 2022).
\112\ Christian Emp'rs All. v. EEOC, No. 21-cv-00195, 2022 WL
1573689 (D.N.D. May 16, 2022).
---------------------------------------------------------------------------
Response: Case law offers strong support for the position that sex
discrimination under section 1557 includes discrimination on the basis
of gender identity and sexual orientation. As previously noted, a body
of developing case law explains how to identify unlawful sex
discrimination. As part of its prohibition on sex discrimination, this
rule prohibits discrimination against individuals who do not conform
with stereotypical notions of how an individual is expected to present
as male or female, regardless of gender identity. This is consistent
with longstanding case law; more than 30 years ago, a plurality of the
Supreme Court held in Price Waterhouse that discrimination based on sex
stereotypes was a prohibited form of sex discrimination. We have
included a number of examples throughout the preamble discussion to
help covered entities better understand their obligations. OCR is also
committed to providing technical assistance to support compliance with
this final rule and may consider additional guidance that may assist
covered entities with their obligations.
As noted in the Proposed Rule, the inclusion of ``sexual
orientation'' and ``gender identity'' in Sec. 92.101(a)(2) is
consistent with the Supreme Court's reasoning in Bostock. 87 FR 47858.
Title IX and section 1557 prohibit discrimination ``on the basis of
sex.'' \113\ And the Bostock Court used the phrase ``because of sex''
and ``on the basis of sex'' interchangeably.\114\ Because the statutory
prohibitions against sex discrimination in title VII and title IX are
similar, the Supreme Court and other Federal courts look to
interpretations of title VII to inform title IX.\115\ Thus, Bostock's
discussion of the text of title VII informs the OCR's analysis of title
IX and section 1557. Given the similarity in nondiscrimination language
between title VII and title IX, many Federal courts that have addressed
the issue have interpreted section 1557 and title IX consistent with
Bostock's reasoning.\116\ Since Bostock, three Federal courts of
appeals have held that the plain language of title IX's prohibition on
sex discrimination must be read similarly to title VII's
prohibition.\117\ OCR agrees with the reasoning in these cases.\118\
Additionally, there is a significant amount of case law, pre-and post-
Bostock that affirms that sex discrimination includes discrimination
based on gender identity.\119\
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\113\ 20 U.S.C. 1681(a); 42 U.S.C. 18116.
\114\ See, e.g., 590 U.S. 653, 662, 681.
\115\ See, e.g., Franklin v. Gwinnett Cnty. Pub. Sch., 503 U.S.
60, 75 (1992); Jennings v. Univ. of N.C., 482 F.3d 686, 695 (4th
Cir. 2007); Gossett v. Okla. ex rel. Bd. Of Regents for Langston
Univ., 245 F.3d 1172, 1176 (10th Cir. 2001).
\116\ See, e.g., Doe v. Snyder, 28 F.4th 103, 113-14 (9th Cir.
2022); Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d 586, 616 (4th
Cir. 2020); but cf. Adams v. Sch. Bd. of St. Johns Cnty, 57 F.4th
791, 811-15 (11th Cir. 2022) (en banc)).
\117\ See A.C. by M.C. v. Metro. Sch. Dist. Of Martinsville, 75
F.4th 760, 769 (7th Cir. 2023); Grabowski v. Ariz. Bd. Of Regents,
69 F.4th 1110, 1116-17 (9th Cir. 2023); Doe v. Snyder, 28 F.4th 103,
113-14 (9th Cir. 2022); Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d
586, 616 (4th Cir. 2020), as amended (Aug. 28, 2020), cert. denied,
141 S. Ct. 2878 (Mem) (2020).
\118\ OCR acknowledges that at least one court has held that it
would be a misapplication of Bostock to interpret the definition of
``sex discrimination'' under section 1557 and title IX to include
gender identity and sexual orientation. In Neese v. Becerra, 640 F.
Supp. 3d 668, the U.S. District Court for the Northern District of
Texas held that the Department misapplied Bostock when it issued a
public notice, 86 FR 27984 (May 25, 2021), stating that it would
interpret section 1557 and title IX's prohibition on sex
discrimination to include discrimination on the basis of sexual
orientation and gender identity. The Department appealed that
decision to the U.S. Court of Appeals for the Fifth Circuit and oral
argument was held on January 8, 2024. The Department is not applying
the challenged interpretation to members of the Neese class pending
the appeal.
\119\ 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). See also Doe v. Snyder,
28 F.4th 103, 113-14 (9th Cir. 2022); Grimm v. Gloucester Cnty. 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 Cnty. Sch. Dist. V. Bryan, 478 P.3d 344, 354 (Nev.
2020).
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We disagree with commenters' assertion that the Court's use of the
term ``transgender status'' in Bostock, rather than ``gender
identity,'' results in any meaningful distinction regarding protections
afforded to transgender individuals or other individuals experiencing
discrimination on the basis of their gender identity. The Court's
choice of language reflects that it was addressing the gender identity
of the plaintiff before it, who was transgender, and does not preclude
the case's application to other gender identities. Indeed, even the
dissent stated that ``there is no apparent difference between
discrimination because of transgender status and discrimination because
of gender identity.'' 590 U.S. at 686, n.6 (Alito, J. joined by Thomas,
J., dissenting).
Additional citations by those opposing the language in Sec.
92.101(a)(2) are either not applicable, already discussed in the
Proposed Rule, or outdated. To begin, this rule does not
[[Page 37575]]
rely on E.O. 13988 for its authority, so criticisms of that order do
not undermine the final rule. State of Tennessee is inapposite. There,
the court held that the plaintiffs had demonstrated a reasonable
likelihood of success on the claim that two other Federal agencies
violated the Administrative Procedure Act by foregoing notice-and-
comment procedures.\120\ That is not at issue here, as this is notice-
and-comment rulemaking and not the issuance of informational documents.
Hosanna-Tabor involved First Amendment limitations on the application
of employment discrimination laws--specifically the ``ministerial
exception'' that precludes application of employment discrimination
laws to ``claims concerning the employment relationship between a
religious institution and its ministers.'' 565 U.S. at 188. As
discussed throughout the Proposed Rule, beginning at 87 FR 47826, OCR
is aware of and discusses both Franciscan Alliance v. Becerra and
Christian Employers Alliance v. EEOC, and the Department is not
prohibited from finalizing this rule by either decision. 87 FR 47826.
Additionally, the final rule adopts new procedures for recipients
wishing to invoke Federal religious freedom and conscience protections.
For more on those procedures, see Sec. 92.302.
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\120\ Tennessee v. U.S. Dep't of Educ., 615 F. Supp. 3d 807
(E.D. Tenn. 2022); appeal docketed, No. 22-5807 (6th Cir. Sept. 13,
2022) (oral argument held April 26, 2023).
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Finally, OCR disagrees with the commenters who cited Franciscan
Alliance v. Burwell, 227 F. Supp. 3d 660 (N.D. Tex. 2016), in support
of the view that section 1557 and title IX's prohibition on sex
discrimination does not include discrimination on the basis of sexual
orientation and gender identity. The legal landscape in this area has
changed since that decision issued and the publication of the Proposed
Rule. The Franciscan Alliance v. Burwell 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.'' Id. at 689. Four years later, 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.'' Bostock, 590 U.S. at
655. The Bostock Court held that the statute's prohibition on
employment discrimination ``because of sex'' encompasses discrimination
on the basis of sexual orientation and gender identity. Id. at 670-71.
Comment: Several commenters generally asserted that sex is an
immutable, biological binary. Some commenters relayed that their
religious beliefs include that sex is an immutable binary. A commenter
stated that sex has a biological component that impacts medical care.
A commenter argued that if the rule does not recognize that sex is
a biological binary, there will be increased confusion in the provision
of medical services. Another commenter expressed concern that the rule
would diminish the quality of health care received by some patients
because some health conditions, such as symptoms of heart attacks, are
based on ``biological sex characteristics.'' A commenter said that a
prohibition of discrimination on the basis of gender identity would
validate the recognition of gender identity and increase gender
dysphoria.
Response: OCR recognizes that sex has biological components and
knowledge of an individual's biological attributes is an essential
component of providing high quality health care for all patients. For
example, in the Proposed Rule, we discussed the various health
disparities experienced by women, which require that providers have
adequate knowledge of biology and anatomy to effectively address. 87 FR
47833-34.
OCR disagrees with commenters suggesting that nondiscrimination
protections on the basis of gender identity will either cause confusion
in the medical profession or lead to diminished quality of care. Health
care providers are highly trained in issues of biology, anatomy, and
physiology. This rule requires that individuals be treated without
discrimination on the basis of sex. There is no evidence that
demonstrates that compliance with civil rights protections, including
on the basis of sex, has caused any confusion in the medical field. On
the contrary, evidence suggests that when patients are protected on the
basis of sex in health care programs, quality of care improves because
patients at risk of discrimination are more likely to seek and receive
high quality care. For example, research shows that individuals who are
experiencing gender dysphoria--defined by the American Psychiatric
Association to include ``clinically significant distress or impairment
related to gender incongruence''--have a clinically significant
decrease in distress if they have access to medically necessary
care.\121\
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\121\ Jack Turban, M.D., M.H.S., What is Gender Dysphoria?, Am.
Psychiatric Assoc., https://www.psychiatry.org/patients-families/gender-dysphoria/what-is-gender-dysphoria (Aug. 2022).
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Moreover, section 1557 prohibits discrimination on certain
prohibited bases, and does not interfere with individualized clinical
judgment about the appropriate course of care for a patient. OCR has a
general practice of deferring to a clinician's judgment about whether a
particular service is medically appropriate for an individual, or
whether the clinician has the appropriate expertise to provide care.
There is no part of section 1557 that compels clinicians to provide a
service that they do not believe is medically appropriate for a patient
or that they are not qualified to provide.
With respect to commenters' concerns about potential conflicts
between the final rule and individuals' or organizations' sincerely
held religious beliefs, we refer commenters to the discussion of this
topic at Sec. 92.302.
Comment: Some commenters stated that because OCR relied on Bostock,
it is bound by the definition of ``sex'' in Bostock and that definition
should be included in the final rule. These commenters opined that the
term ``sex characteristics'' as used by OCR is sometimes contrary to a
binary understanding of the term ``sex,'' and accordingly ``sex
characteristics'' either must be avoided in the regulations or used in
a manner not to contradict the term ``sex'' being binary.
Response: OCR has determined it is not necessary to define ``sex''
in this rule, as we have addressed a non-exhaustive list of what
constitutes discrimination on the basis of sex at Sec. 92.101(a)(2).
The Supreme Court did not define the term ``sex'' in Bostock, but
rather noted that nothing in their approach to the cases considered
turned on the debate over whether ``sex'' was limited to ``biological
distinctions between male and female,'' and the Court therefore
proceeded on the assumption that ``sex'' carried that meaning. 590 U.S.
at. 655.
OCR declines to remove reference to ``sex characteristics''
(including intersex traits) from Sec. 92.101(a)(2). Discrimination on
the basis of sex characteristics, including intersex variations, is a
prohibited form of sex discrimination because discrimination based on
anatomical or physiological sex characteristics is inherently sex-
based. See 87 FR 47858.
Comment: Numerous commenters supported the explicit inclusion of
[[Page 37576]]
discrimination based on sex characteristics, including intersex traits,
stating that discrimination based on intersex traits is inherently sex-
based. Several commenters supported this proposal, citing barriers to
appropriate care and coverage resulting from discrimination suffered by
intersex patients.\122\ These commenters cited a report in which more
than half of intersex respondents reported that a provider refused to
see them because of their sex characteristics or intersex variation and
that almost two-thirds reported having concerns that if they disclosed
their intersex status to a provider, they could be denied quality
medical care.\123\ A few commenters recommended that Sec. 92.101(a)(2)
include concrete examples of sex discrimination, specifically on the
basis of intersex traits.
---------------------------------------------------------------------------
\122\ Lambda Legal & interACT Advocates, Providing Ethical and
Compassionate Health Care to Intersex Patients: Intersex-Affirming
Hospital Policies (2018), https://legacy.lambdalegal.org/sites/default/files/publications/downloads/resource_20180731_hospital-policies-intersex.pdf.
\123\ See Caroline Medina & Lindsay Mahowald, Ctr. for Am.
Progress, Advancing Health Care Nondiscrimination Protections for
LGBTQI+ Communities (2022), https://www.americanprogress.org/article/advancing-health-care-nondiscrimination-protections-for-lgbtqi-communities.
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Response: Discrimination based on sex characteristics is a
prohibited form of sex discrimination because discrimination based on
anatomical or physiological sex characteristics is inherently sex-
based. 87 FR 47858. It follows that discrimination on the basis of
intersex traits is prohibited sex discrimination because the individual
is being discriminated against based on their sex characteristics.
Comment: Numerous commenters generally supported the inclusion of
pregnancy or related conditions as protected bases of sex
discrimination at Sec. 92.101(a)(2) and recommended that OCR include
examples of pregnancy-related discrimination. Commenters recommended
including protection for pregnancy-related conditions as a standalone
provision to emphasize the importance of these protections. Commenters
stated that protection against discrimination on the basis of pregnancy
or related conditions would protect many patients. Commenters also
pointed out that as drafted, the Proposed Rule does not consistently
define sex discrimination to include pregnancy-related conditions
because other sections just state ``pregnancy'' as opposed to
``pregnancy or related conditions.'' The commenters urged OCR to be
consistent throughout the rule.
Response: The inclusion of ``pregnancy or related conditions'' is
consistent with the longstanding interpretation of the ``ground'' of
discrimination prohibited under title IX because pregnancy-based
discrimination has long been understood as a form of sex-based
discrimination under title IX. For many years preceding the enactment
of the ACA, the Department (along with other agencies) determined that
discrimination based on pregnancy or related conditions is
discrimination based on sex.\124\ Discrimination on the basis of
pregnancy or related conditions may include, but is not limited to,
instances of individuals who experience discrimination throughout
pregnancy, labor and delivery, or the postpartum period. OCR agrees
that the explicit inclusion of pregnancy or related conditions in the
rule text is important for protecting many patients from
discrimination.
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\124\ See 45 CFR 86.21(c)(2), (3); 86.40(b)(1), (4), and (5);
86.51(b)(6); 86.57(b)(d) (title IX regulation).
---------------------------------------------------------------------------
As discussed in the Proposed Rule, OCR considered inclusion of a
provision to specifically address discrimination on the basis of
``pregnancy or related conditions.'' 87 FR 47878. We received comments
stating that a separate section was not appropriate. Those comments
recommended that this issue be addressed under either Sec. 92.101
(Discrimination prohibited) or Sec. 92.206 (Equal program access on
the basis of sex). Accordingly, we maintain the inclusion of
``pregnancy or related conditions'' here under Sec. 92.101(a)(2). For
a further discussion of ``pregnancy or related conditions,'' please
refer to the preamble discussion at Sec. 92.208 (Prohibition on sex
discrimination related to marital, parental, or family status).
Comment: A commenter stated that protections from pregnancy-based
discrimination should include an informed consent requirement for
abortion and childbirth, because the commenter asserted that consent
for a Cesarean delivery is often obtained through coercion.
Response: As noted in the Proposed Rule, 87 FR 47868, 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.\125\ OCR declines to make any changes in response to
this comment.
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\125\ Am. Med. Ass'n, Informed Consent, https://www.ama-assn.org/delivering-care/ethics/informed-consent.
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Comment: Numerous commenters recommended that, in light of the
Supreme Court's decision in Dobbs v. Jackson Women's Health
Organization, 142 S. Ct. 2228 (2022), and increased restrictions on
reproductive health, OCR should provide that ``pregnancy or related
conditions'' includes termination of pregnancy in the final rule. A
group of commenters opined that the definition of ``pregnancy or
related conditions'' should expressly exclude an abortion.
Several commenters stated that OCR should clarify that this
provision protects patients from discrimination on the basis of actual
or perceived prior abortions. Several commenters stated that, as a
result of abortion bans that have gone into effect post-Dobbs, women
have been denied critical care, such as cancer treatment, because of
abortion-related concerns. A commenter wrote that abortion is often
necessary to save patients' lives, especially from complications like
ectopic pregnancy or premature rupture of membrane.
Response: OCR appreciates commenters' concerns and recognizes that
the Supreme Court decision in Dobbs changed the legal landscape as to
abortion access. While we agree that protections afforded for pregnancy
or related conditions include termination of pregnancy, OCR declines to
revise the language at Sec. 92.101(a)(2) to include or exclude
specific examples and will interpret section 1557's protections on the
basis of sex consistent with applicable case law addressing
discrimination on the basis of sex, including pregnancy or related
conditions.
OCR has concluded as a matter of statutory interpretation that
section 1557 does not require the Department to incorporate the
language of title IX's abortion neutrality provision, see preamble
discussion at Sec. 92.208 (Prohibition on sex discrimination related
to marital, parental, or family status). At the same time, OCR
emphasizes that a covered provider's decision not to provide abortions
does not itself constitute discrimination in violation of section 1557.
Also, a covered provider's willingness or refusal to provide, pay for,
cover, or refer for abortion or to provide or participate in training
to provide abortion also is not discrimination under section 1557.
Section 1557 prohibits discrimination on the basis of race, color,
national origin, sex, age, or disability in covered health programs or
activities. A covered provider that generally offered abortion care
could violate that prohibition if, for example, it refused to provide
an abortion to a particular patient because of that patient's race or
disability. But a covered provider does not engage in
[[Page 37577]]
discrimination prohibited by section 1557 if it declines to provide
abortions based on religious or conscience objections to performing the
procedure, based on a professional or business judgment about the scope
of the services it wishes to offer, or for any other nondiscriminatory
reason.
It bears emphasis that nothing in the ACA, including section 1557,
has ``any effect on Federal laws regarding--(i) conscience protection;
(ii) willingness or refusal to provide abortion; and (iii)
discrimination on the basis of the willingness or refusal to provide,
pay for, cover, or refer for abortion or to provide or participate in
training to provide abortion.'' 42 U.S.C. 18023(c)(2)(A). In addition,
nothing in the ACA, including section 1557, preempts or has any effect
on State laws regarding ``the prohibition of (or requirement of)
coverage, funding, or procedural requirements on abortions'' as
provided in section 1303 of the ACA, 42 U.S.C. 18023(c)(1).
Against this legal landscape, OCR will evaluate specific claims of
discrimination on prohibited bases on a case-by-case basis, and we
decline to revise the language at Sec. 92.101(a)(2). We note also
that, as commenters suggested, this provision protects patients from
discrimination on the basis of actual or perceived prior abortions. For
example, a recipient's denial of unrelated medical care that the
provider generally provides to other patients to an individual based
solely on the fact they had a prior abortion would constitute
prohibited discrimination within the meaning of section 1557. Moreover,
both the 2016 and 2020 Rules recognized that discrimination on the
basis of pregnancy termination can be a form of sex discrimination.
Comment: Conversely, a commenter argued that OCR should not
interpret ``pregnancy or related conditions'' to include ``termination
of pregnancy'' because of a concern that it will force health care
providers to participate in abortions and requested that OCR provide
further clarification as to what types of conduct would be prohibited
discrimination under the rule. Another commenter stated the Proposed
Rule wrongly treats abortion as a right protected from sex
discrimination and that title IX contains an abortion neutrality
provision that the rule would contravene.
Response: As discussed above, a covered provider's decision not to
provide abortions does not itself constitute discrimination in
violation of section 1557. A covered provider does not engage in
discrimination prohibited by section 1557 if it declines to provide
abortions based on religious or conscience objections to performing the
procedure, based on a professional or business judgment about the scope
of the services it wishes to offer, or for any other nondiscriminatory
reason. A covered entity that chooses to provide abortion care but
refuses to provide an abortion for a particular individual on the basis
of a protected ground--such as race--would violate section 1557. For
discussion regarding the title IX abortion neutrality provision, please
see Sec. 92.208.
Comment: Several commenters requested that OCR clarify that Sec.
92.101(a)(2) prohibits discrimination against individuals when they are
seeking or accessing fertility care, maternity care, and other
reproductive health care specifically. A commenter recommended that OCR
clarify that pregnancy-related care applies throughout pregnancy,
childbirth, and the postpartum period.
Response: Section 1557 protects individuals against prohibited
discrimination in all covered health programs and activities regardless
of the type of care they are seeking or accessing, including fertility
care, maternity care, and other reproductive health care. Similarly,
section 1557 protects individuals seeking or accessing health programs
and activities provided for or during preconception, pregnancy,
childbirth, and postpartum recovery. Ensuring that section 1557's
protections apply throughout the continuum of care is especially
critical for Black women and other people of color, who face worse
health outcomes and experience higher rates of discrimination
throughout pregnancy and the postpartum period.\126\
---------------------------------------------------------------------------
\126\ Saraswathi Vedam et al., The Giving Voice to Mothers
Study: Inequity and Mistreatment During Pregnancy and Childbirth in
the United States, 16 Reprod. Health 1 (2019), https://doi.org/10.1186/s12978-019-0729-2.
---------------------------------------------------------------------------
Comment: Many commenters raised concerns about barriers to
reproductive health care faced by LGBTQI+ patients. A commenter
strongly urged more explicit inclusion of ``fertility'' as a form of
impermissible sex-based discrimination--so that Sec. 92.101(a)(2)(ii)
prohibits discrimination on the basis of ``pregnancy, fertility, or
related conditions''--as infertility is a serious issue that impacts
many LGBTQI+ populations. Commenters stated that LGBTQI+ people
continue to face barriers to fertility treatment, such as in vitro
fertilization (IVF), and that coverage of fertility treatments often
limit or exclude LGBTQI+ patients.
Response: OCR acknowledges the unique challenges faced by LGBTQI+
individuals seeking fertility treatment. Individuals are protected from
discrimination regardless of the type of health care they seek, and we
have concluded it is unnecessary to provide provisions for each
specific form of health care available. Whether discrimination on the
basis of sexual orientation or gender identity occurred in the
provision or coverage of assistive reproductive technology--such as
IVF--is necessarily fact specific. However, if a covered entity elects
to provide or cover fertility services but categorically denies them to
same-sex couples, it may violate section 1557's prohibition on sex
discrimination.
Comment: Numerous commenters generally supported inclusion of
sexual orientation as a protected basis for sex discrimination, and
said that its inclusion would improve health care for LGBTQI+
individuals. Many commenters stated that LGBTQI+ individuals face
discriminatory challenges to accessing health care and that the rule
would alleviate these issues. Many commenters wrote that LGBTQI+
individuals often anticipate that they will experience discrimination
in health care and thus often may not seek out care.
Response: It is well documented that LGBTQI+ individuals face
discrimination when accessing or attempting to access health care and
health insurance. Section 1557 is a critical tool in combating such
discrimination and addressing the resulting health disparities and
other negative impacts.
Comment: Numerous commenters generally supported the inclusion of
discrimination on the basis of gender identity as a prohibited form of
sex discrimination. Other commenters recommended including
``transgender or nonbinary status,'' ``nonbinary and gender-
nonconforming,'' and ``including status as transgender, nonbinary,
gender nonconforming, two-spirit, or other gender.''
Response: OCR recognizes that individuals use various terminology
to describe their gender identity. For this reason, we decline to
provide a definition of ``gender identity'' or ``transgender status''
in the regulation. We reiterate here that OCR will investigate
discrimination against an individual based on having a gender identity
that is different from their sex assigned at birth as discrimination on
the basis of gender identity, regardless of whether the individual
identifies with or uses the term ``transgender'' or another identity.
OCR is aware that the Bostock majority uses the term ``transgender
[[Page 37578]]
status'' exclusively. But Bostock reasoned that when a person
discriminates ``against transgender persons, the employer unavoidably
discriminates against persons with one sex identified at birth and
another today'' such that ``[a]ny way you slice it, the employer
intentionally refuses to hire applicants in part because of the
affected individuals' sex, even if it never learns any applicant's
sex.'' See Bostock, 590 U.S. at 669. This therefore includes
discrimination against a person because they are transgender, or
because they identify in some other way that is inconsistent with their
sex assigned at birth, e.g., because they are gender nonconforming.
Such discrimination is also based on requiring persons to conform to
stereotypical norms about sex and gender, which can also serve as the
basis for impermissible sex discrimination. See, e.g., Whitaker, 858
F.3d at 1048-49 (citing Price Waterhouse, 490 U.S. at 251). Therefore,
the prohibition against discrimination based on gender identity, rather
than just transgender status, more fully protects individuals from
prohibited sex discrimination. Indeed, the Bostock dissent stated that,
as defined by the American Psychological Association, ``there is no
apparent difference between discrimination because of transgender
status and discrimination because of gender identity.'' 590 U.S. at
686, n.6 (Alito, J. joined by Thomas, J., dissenting).
Comment: Several commenters supported OCR's general goal at Sec.
92.101(b) of explicitly incorporating the prohibitions on
discrimination found in title VI, section 504, title IX, and the Age
Act and thought this approach is prudent, given that some health care
entities may not be readily familiar with the specific regulatory
standards and obligations that apply to them under civil rights laws. A
few commenters noted that incorporating section 504 regulations
pertaining to accessibility could create conflicting obligations and
specifically objected to incorporating 45 CFR 84.23(c), which applies
an outdated standard (the Uniform Federal Accessibility Standards) to
new facility constructions. These commenters recommended including
additional language in Sec. 92.101(b)(1)(i) that expressly states
``(except for Sec. 84.23(c)).''
Response: We appreciate commenters' concerns regarding inclusion of
Sec. 84.23(c). Because the rule has a separate subsection with respect
to ``Accessibility for buildings and facilities,'' commenters should
refer to this preamble's discussion of Sec. 92.203.
Comment: Some commenters requested that OCR restore the 2016 Rule
clarification that any age distinctions exempt from the Age Act are
also exempt from section 1557 enforcement.
Response: OCR appreciates commenters' request for clarity regarding
the Age Act's permitted age distinctions. This rule adopts by reference
the Age Act implementing regulation provisions at 45 CFR part 91
(subpart B), which explicitly recognize that some age distinctions may
be necessary to the normal operation of a program or activity or to the
achievement of any statutory objective. See 45 CFR 91.13 (adopting
statutorily permissive age distinctions found at 42 U.S.C. 6103(b)(1)).
Comment: A commenter stated that OCR should exercise its authority
to enforce disparate impact claims in order to address systemic
discrimination in health care.\127\ Another commenter supported the
approach taken by OCR in the Proposed Rule to not include the site
location provision from the 2016 Rule, stating they believed section
1557's context, structure, and text make evident that Congress did not
intend to import multiple, piecemeal legal standards and burdens of
proof derived from different statutory contexts into the doctrinal
patchwork; and that section 1557 provides the full range of enforcement
mechanisms and remedies available to any person pursuing a
discrimination claim under section 1557, regardless of their protected
characteristic.
---------------------------------------------------------------------------
\127\ Ruqaiijah Yearby et al., Structural Racism in Historical
and Modern US Health Care Policy, 41 Health Affairs 187 (2022),
https://www.healthaffairs.org/doi/10.1377/hlthaff.2021.01466; Joe
Feagin & Zinobia Bennefield. Systemic Racism and U.S. Health Care,
103 Soc. Sci. & Med. 7 (2014), https://doi.org/10.1016/j.socscimed.2013.09.006; Cara A. Fauci, Racism and Health Care in
America: Legal Responses to Racial Disparities in the Allocation of
Kidneys, 21 Boston Coll. Third World J. 35 (2001); Amitabh Chandra
et al., Challenges to Reducing Discrimination and Health Inequity
through Existing Civil Rights Laws, 36 Health Affairs 1041 (2017),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5654529/.
---------------------------------------------------------------------------
Response: After reviewing comments, OCR declines to include
provisions similar to former 45 CFR 92.101(b)(3)(ii) and (iii), which
are not included in the 2020 Rule. OCR will preserve the longstanding
treatment of discrimination in the referenced statutes' implementing
regulations consistent with relevant case law.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing the provision as proposed in Sec. 92.101,
with modifications. We added ``or any combination thereof'' after
disability and deleted the ``or'' before disability in Sec.
92.101(a)(1).
Subpart C--Specific Applications to Health Programs and Activities
Because of section 1557's specific application to health programs
and activities, subpart C provides additional detail regarding
nondiscrimination requirements in these settings. The provisions in
this subpart are responsive to the nature and importance of health
care, health insurance coverage, and other health-related coverage, and
related health programs and activities as those health-related issues
impact 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
experience in both enforcement and in providing technical assistance as
well as outreach to interested parties.
Meaningful Access for Individuals With Limited English Proficiency
(Sec. 92.201)
In proposed Sec. 92.201, we proposed provisions to effectuate
section 1557's prohibition on national origin discrimination as it is
applied to individuals with LEP in covered health programs and
activities. In Sec. 92.201(a), we proposed 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.''
In Sec. 92.201(b), we proposed that language assistance services
required under Sec. 92.201(a) must be provided free of charge, be
accurate and timely, and protect the privacy and independent decision-
making ability of an individual with LEP.
In Sec. 92.201(c), we proposed specific requirements for
interpreter and translation services. Section 92.201(c)(1) proposed
that when interpreter services are required under this part, a covered
entity must offer a qualified interpreter. Section 92.201(c)(2)
proposed that when translation services are required under this part, a
covered entity must use a qualified translator.
In Sec. 92.201(c)(3), we proposed 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
individual with LEP; when accuracy is essential; or when the source
documents or materials contain complex, non-literal, or technical
language. We sought
[[Page 37579]]
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.
In Sec. 92.201(d), we addressed how the Director will evaluate
compliance with this section. In Sec. 92.201(d)(1), we proposed 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 individual with LEP. Proposed Sec.
92.201(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).
In Sec. 92.201(e), we proposed restrictions on the use of certain
persons to provide language assistance services for individuals with
LEP. In Sec. 92.201(e)(1), we proposed prohibitions on covered
entities from requiring individuals with LEP to provide, or pay for,
their own interpreters. Proposed Sec. 92.201(e)(2) provided for very
limited situations in which an adult, not qualified as an interpreter,
accompanying an individual with LEP can serve as an interpreter.
Section 92.201(e)(3) proposed to prohibit 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
individual with LEP immediately available. In Sec. 92.201(e)(4), we
proposed prohibiting reliance on staff other than qualified
interpreters, qualified translators, or qualified bilingual or
multilingual staff to communicate directly with individuals with LEP.
In Sec. 92.201(f), we proposed standards for video remote
interpreting (VRI).
In Sec. 92.201(g), we proposed standards for audio remote
interpreting services.
In Sec. 92.201(h), we proposed that nothing in this section shall
be construed to require an individual with LEP to accept language
assistance services.
The comments and our responses regarding Sec. 92.201 are set forth
below.
Comment: Many commenters were very supportive of Sec. 92.201(a)'s
requirement that covered entities must take reasonable steps to provide
meaningful access to ``each'' individual with LEP eligible to be served
or likely to be directly affected by its health programs and
activities. Commenters also supported OCR's revision concerning
individuals with LEP ``likely to be directly affected'' by a health
program or service, as opposed to the previous ``likely to be
encountered,'' as it provides greater clarity about the applicability
of this rule and reduces some burden on health care practices.
Commenters maintained that this standard provides a better description
for providers to understand. Other commenters supported inclusion of
``eligible to be served or likely to be directly affected'' because
they believe it expands the definition of who can receive language
access and better reflects how language service needs are experienced
by people seeking health care. Many commenters recommended that OCR
clarify that companions are expressly included, noting that this is
especially important for caretakers of minor children or those
accompanying older adults.
Response: OCR appreciates commenters' thoughts on the language at
Sec. 92.201(a) and confirms that covered entities' language access
obligations also apply to companions (defined in Sec. 92.4), as
companions are ``directly affected by [a covered entity's] health
programs and activities'' by virtue of their relationship with the
person whom they are accompanying. For example, a covered entity will
need to take reasonable steps to provide meaningful access to a parent
with LEP whose minor child is being treated or an individual with LEP
who may be assisting their spouse with post-operative care. To
reinforce this requirement, OCR is adding a parenthetical to the text
of Sec. 92.201(a) to clarify that individuals with LEP who are covered
under this part include companions with LEP. This language is
consistent with the requirement to provide effective communication for
companions with disabilities under Sec. 92.202.
Comment: Various commenters appreciated OCR providing clarity on
the terms ``reasonable steps'' and ``meaningful access,'' noting that
the 2020 Rule's deletion of meaningful access requirements was
detrimental to the health of communities with LEP. A few commenters
recommended that clearer directives should be included as to what types
of services constitute ``reasonable steps,'' suggesting this could be
clarified by providing examples of ``reasonable steps,'' or by adding
definitions of ``reasonable steps'' and ``meaningful access'' to Sec.
92.4 (Definitions). Another commenter cautioned that the lack of
clarity could result in covered entities coming to the determination
that no services are required of them. Others stated that additional
guidance is needed specifically for providers and payers.
Response: OCR appreciates the request for additional definitions;
however, we decline to provide a definition for ``reasonable steps'' or
``meaningful access,'' as these terms are not unique to section 1557
and reflect longstanding requirements under title VI. OCR will consider
developing additional guidance on this topic but also refers commenters
to the Department's longstanding HHS LEP Guidance, 67 FR 47311, as well
as the Department's 2023 Language Access Annual Progress Report. The
2023 Progress Report describes the Department's reconstituted Language
Access Steering Committee based on the HHS Equity Action Plan issued
under E.O. 13985, clarifies benchmarks for meaningful language access
in key areas such as developing best practices for oral interpretation
and internet-based access to written translation, and sets forth
current plans to update the Department's Language Access Plans and
issue related guidance.\128\
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\128\ U.S. Health & Hum. Servs., Off. for Civil Rts., 2023
Language Access Annual Progress Report (2023), https://www.hhs.gov/sites/default/files/language-access-report-2023.pdf.
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Comment: A number of commenters stated that failure to provide
meaningful access may violate both section 1557's national origin
prohibition and the prohibition on race discrimination. Several
commenters stated that there are instances in which an individual
experiences discrimination based on their limited English proficiency,
in addition to another protected characteristic. For example, a person
who is Black and has limited English proficiency is more likely to
experience discrimination in health care settings than an individual
who is Black but does not have limited English proficiency or an
individual with limited English proficiency but who is not Black.\129\
Commenters stated that this type of discrimination may deter patients
from seeking critical health care services, leading to adverse health
outcomes and decreased trust in the health care system.\130\ Commenters
also
[[Page 37580]]
provided data showing that almost one in four health center patients
communicate in a language other than English; \131\ 63 percent of
individuals with LEP identify as Hispanic/Latino; \132\ language
barriers have been proven to contribute to health inequities for Asian
American, Native Hawaiian, and Pacific Islander individuals in
particular; \133\ and people with LEP are less likely to receive
primary care and preventive care, such as breast and cervical cancer
screenings.\134\
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\129\ Neelam H. Ahmed et al., Moderation of the Association
Between Primary Language and Health by Race and Gender: An
Intersectional Approach, 19 Int. J. Environ. Rsch. Pub. Health 7750
(2022), https://www.mdpi.com/1660-4601/19/13/7750.
\130\ Neelam H. Ahmed et al., Moderation of the Association
between Primary Language and Health by Race and Gender: An
Intersectional Approach, 19 Int. J. Environ. Rsch. Pub. Health 7750
(2022), https://www.mdpi.com/1660-4601/19/13/7750: Francisco Ramos-
Gomez et al., Addressing Social Determinants of Oral Health,
Structural Racism and Discrimination and Intersectionality among
Immigrant and Non-English Speaking Hispanics in the United States,
82 J. Pub. Health Dentistry 133 (2022), https://doi.org/10.1111/jphd.12524.
\131\ Kathryn Pitkin Derose et al., Limited English Proficiency
and Latinos' Use of Physician Servs., 57 Med. Care Rsch. Rev. 76
(2000), https://doi.org/10.1177/107755870005700105.
\132\ Jie Zong & Jeanne Batalova, Migration Pol'y Inst., The
Limited English Proficient Population in the United States in 2013
(2015), https://www.migrationpolicy.org/article/limited-english-proficient-population-united-states-2013.
\133\ Gilbert C. Gee et al., Associations Between Racial
Discrimination, Limited English Proficiency, and Health-Related
Quality of Life Among 6 Asian Ethnic Groups in California, 100 Am.
J. of Pub. Health 891 (2010), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853608/.
\134\ Elizabeth A. Jacobs et al., Limited English Proficiency
and Breast and Cervical Cancer Screening in a Multiethnic
Population, 95 Am. J. Pub. Health, 1410 (2005), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1449374/; Israel De Alba et
al., English Proficiency and Physicians' Recommendation of Pap
Smears Among Hispanics, 30 Cancer Detection & Prevention 292 (2006),
https://pubmed.ncbi.nlm.nih.gov/16844320/; Lisa Diamond et al., A
Systematic Review of the Impact of Patient-Physician Non-English
Language Concordance on Quality of Care and Outcomes, 34(8) J. Gen.
Internal Med. 1591 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667611/; Kelly H. Bruce et al., Barriers and
Facilitators to Prevent Cancer Screening in Limited English
Proficient (LEP) Patients: Physicians' Perspectives, 11 Commc'ns.
Med. 235 (2014), https://journal.equinoxpub.com/CAM/article/view/8592.
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Some commenters also specifically addressed the importance of
language assistance services for older individuals with LEP. These
commenters submitted research demonstrating that it is especially
difficult for older adults with LEP to communicate with providers
because of limited English proficiency, low health literacy, and lack
of translators and interpreters.\135\ Many commenters argued that to
ensure access to quality care, covered entities must have translators
and interpreters available at all points of contact at no cost to an
individual. This is because older adults may be less inclined to ask
for language assistance or may rely on family members who are not
qualified to interpret health information. Additionally, the commenters
noted that language assistance services are critical for people at the
end of life who, absent these services, cannot give true informed
consent or thoroughly understand their end-of-life care options.
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\135\ U.S. Dep't of Health & Hum. Servs., Ctr. for Disease
Control, Adults with Disabilities: Ethnicity and Race, https://www.cdc.gov/ncbddd/disabilityandhealth/materials/infographic-disabilities-ethnicity-race.html (citing Elizabeth A. Courtney-Long
et al., Socioeconomic Factors at the Intersection of Race and
Ethnicity Influencing Health Risks for People with Disabilities, 4
J. Racial and Ethnic Health Disparities 213 (2017), https://pubmed.ncbi.nlm.nih.gov/27059052/); Francisco J. Medrano et al.,
Limited English Proficiency in Older Adults Referred to the
Cardiovascular Team, 136 Am. J. of Med. 466 (2023); Terceira A.
Berdahl et al., Patient-Provider Communication Disparities by
Limited English Proficiency (LEP): Trends from the US Medical
Expenditure Panel Survey, 2006-2015, 34 J. Gen. Internal Med. 1434
(2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6667581/.
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Response: OCR appreciates these comments and the data submitted. As
discussed elsewhere in this preamble, section 1557's language access
requirements derive from the statute's prohibition on discrimination
against national origin. OCR also appreciates, and agrees with,
comments highlighting the ways in which individuals may experience
discrimination on multiple grounds as well as comments about the
importance of language assistance services for older individuals with
LEP. The provisions for Sec. 92.201(a) enhance health access and
reduce discrimination by requiring covered entities to take reasonable
steps to provide meaningful access to each individual with LEP.
Comment: Many commenters stated that language assistance has often
been costly to the individuals with LEP, and translations have often
been inaccurate, incomplete, or both. Commenters additionally noted
that language assistance has often been provided later in time than
other services and that interpretation has not been done in a way that
protects patient privacy. Other commenters submitted examples of
individuals with LEP being provided with incomplete information, such
as being told of only one treatment option, rather than be told of
other available treatment options.
Response: We appreciate concerns raised regarding cost, timeliness,
and privacy concerns, which we address in Sec. 92.201(b). Consistent
with language access requirements in the 2016 and 2020 Rules, required
language assistance services must be provided free of charge, be
accurate and timely, and protect the privacy of the individual with
LEP. Inaccurate or incomplete translations or interpretation may
violate the accuracy standard found in this provision and the
overarching requirement to take reasonable steps to provide meaningful
access. Accuracy issues are further addressed by requiring covered
entities to use the services of qualified interpreters and translators,
at Sec. 92.201(c).
Comment: Commenters noted a lack of definition for timeliness in
Sec. 92.201(b), and one recommended OCR establish time, distance, and
wait time standards. Another commenter suggested that the timeliness
standard take into account the geographic location of the covered
entity and the hour of the day when the need for language assistance
services arises.
Response: As OCR discusses in the HHS LEP Guidance, timeliness may
depend on multiple variables and so no one definition would be
reasonable or applicable to ``all types of interactions at all times by
all types of recipients.'' 68 FR 47316. However, language assistance
should be provided at a time and place that avoids the effective denial
of the service, benefit, or right at issue or the imposition of an
undue burden on or delay in important rights, benefits, or services to
the person with LEP. 68 FR 47316. When evaluating a complaint, OCR will
consider the context, including the urgency and importance of many
health care services. We encourage covered entities to review the HHS
LEP Guidance for additional guidance.
Comment: Several commenters stated that language assistance
services should be required to include cultural competency and that
providers should reflect the community around them in order to build
trust. One commenter noted that during listening sessions they
conducted, participating health centers emphasized the important role
that bilingual and bicultural staff who represent the community served
to provide accurate and culturally comprehensible interpretation. A few
commenters recommended requiring covered entities to ensure sufficient
staff with appropriate training and to administer language proficiency
assessments to confirm competency of bilingual and multilingual staff.
Some commenters urged that translators and interpreters be from or
a part of the impacted community in which they serve, with some
suggesting that community-based interpreters and translators may be
more qualified for a number of reasons, including familiarity with
local dialect and cultural competency. Others, however, stated that
family members and community service providers or other external groups
should not have to bear the burden of interpreting.
Response: OCR generally agrees that cultural competency is
essential for
[[Page 37581]]
equitable language access and communications.\136\ This is especially
important considering variations in dialects, expressions, or
``regionalisms.'' For example, a Spanish word that may be understood to
mean something for someone from Puerto Rico may mean something else for
someone from Mexico. Thus, cultural competency is a key factor in
providing accurate interpretation and translation, and accuracy is a
necessary component of meaningful access.
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\136\ See U.S. Dep't of Health & Hum. Servs., Off. of Minority
Health, Think Cultural Health, National Standards for Culturally and
Linguistically Appropriate Services (CLAS) in Health and Health
Care, https://thinkculturalhealth.hhs.gov/assets/pdfs/EnhancedNationalCLASStandards.pdf (recommending that health
organizations: ``[p]rovide effective, equitable, understandable, and
respectful quality care and services that are responsive to diverse
cultural health beliefs and practices, preferred languages, health
literacy, and other communication needs,'' through providing
language assistance and ``[e]stablish[ing] culturally and
linguistically appropriate goals, policies, and management
accountability, and infuse them throughout the organization's
planning and operations'').
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OCR recognizes that community members may be more likely to be
culturally competent but declines to include in the regulatory text a
requirement that translators and interpreters be from the community
they serve. Covered entities are free to determine their own hiring and
contracting processes for utilizing the services of qualified
interpreters and translators, and hiring bilingual/multilingual staff,
as long as these individuals meet the requirements for their respective
positions as provided in Sec. 92.4 (Definitions).
Comment: Many commenters supported the novel proposal to address
machine translation in this regulation, with some requesting that
machine translation always be checked by a qualified human translator
and that patients be advised when a translation has been completed by
machine translation due to high error rates. One commenter specified
that covered entities should not use Google Translate as the only
resource for translations as it generates errors, pointing to a State
Department of Health website translating ``the vaccine is not
required'' for COVID-19 to ``the vaccine is not necessary'' in Spanish
(since corrected). Other commenters stated that the rule does not
adequately account for future innovations and that the final rule
should include an exception for exigent circumstances. Insurance
entities and other providers commented that machine translation is a
viable option to reduce costs in some instances.
Response: OCR recognizes that machine translation is an evolving
technology. However, given that it still carries significant potential
for error, we believe this provision strikes an appropriate balance
between the convenience some may find in this technology and the
critical nature of communications in the health care context. We
appreciate commenters' concerns regarding exigent circumstances, where
use of machine translation technology may provide immediate language
assistance capabilities in very urgent circumstances. As provided under
Sec. 92.201(a), ``[a] covered entity must take reasonable steps to
provide meaningful access to each individual with limited English
proficiency (including companions with limited English proficiency)
eligible to be served or likely to be directly affected by its health
programs and activities.'' For example, if an emergency medical
technician must provide urgent medical care to an individual with LEP,
and no other language assistance services are available, it may be
reasonable to use machine translation technology to communicate with
that person while a qualified interpreter is identified. We note that
the definition for machine translation found at Sec. 92.4 under this
final rule ``means automated translation . . . that is text based and
provides instant translations between various languages,'' which
includes automated translation covers speech as well as written
communications. However, given the importance of communication and
understanding in the health care and services setting, OCR requires
that in such circumstances, the machine translation must be
subsequently checked by a qualified human translator as soon as
practicable. OCR also recommends that, if machine translation is used
in circumstances that do not require human review (i.e., those
circumstances that do not meet the criteria set forth in Sec.
92.201(c)(3)), the patients should be warned that it may contain
errors. OCR directs commenters to Sec. 92.4 (Definitions) for further
discussion on machine translation and future technology.
Comment: OCR received limited comments on our proposed revisions to
the factors the Director will take into account when evaluating
compliance with language access obligations (proposed Sec. 92.201(d)).
Several commenters supported discontinuing the 2020 Rule's use of the
``four-factor analysis,'' 45 CFR 92.101(b)(1), found in the HHS LEP
Guidance, 68 FR 47314-16, to determine compliance with a covered
entity's language access requirements under section 1557. These
commenters stated that the four-factor analysis is too vague to be
useful for oversight of compliance and does not provide direction on
how each of the factors would be weighed against each other.
Conversely, a few commenters recommended that OCR retain the four-
factor analysis since it provides covered entities more flexibility.
These commenters noted that recipients must have flexibility in
achieving compliance with requirements for language access because of
their limited resources and patient populations.
A few commenters noted that the phrase ``other relevant factors''
in Sec. 92.201(d) is vague and should either be removed or clarified.
Specifically, they said that compliance has been an ongoing problem and
more information is needed to help covered entities understand the
factors that will be used for evaluation of compliance. Additionally,
one commenter recommended that the final rule include the geographic
location of the covered entity and the hour of the day when the need
for language assistance services arises as one of the factors for OCR
to consider in evaluating compliance. For example, the ability of a
small, rural provider to find an interpreter for an individual with LEP
at midnight on a Saturday is going to be substantially more challenging
than it would be for a provider in an urban setting.
Response: As discussed in the 2022 NPRM, 87 FR 47862, after
additional consideration OCR determined that the four-factor test was
not a sufficiently precise or flexible compliance tool. Section
92.201(d)(1) provides flexibility that allows the Director to take into
account a range of relevant factors, including the ``nature and
importance of the health program or activity and the particular
communication at issue, to the individual with limited English
proficiency.'' Additionally, Sec. 92.201(d)(2) allows for the
consideration of ``other relevant factors,'' including those that
relate to whether ``reasonable steps'' were taken in a given situation.
Thus, the Director may take into account the geographic location and
timing considerations posed by the commenter's example in evaluating
whether ``reasonable steps'' were taken.
Comment: Many commenters supported the inclusion of an explicit
prohibition on the use of certain persons to interpret or facilitate
communication, including the expectation that in an emergency
situation, reliance on an accompanying adult or minor should be ``a
temporary measure'' at Sec. 92.201(e).
[[Page 37582]]
Commenters stated that children oftentimes are asked to interpret
medical information for which they do not have the vocabulary or
content knowledge. Some also stated that older adults with LEP may feel
pressure to rely on family members as interpreters, even if those
family members are not qualified to interpret health information, which
can inhibit the older adult's understanding of their health status and
instructions from their provider.
Response: We appreciate the commenters' support and underscore that
untrained ``interpreters'' are more likely to make errors, violate
confidentiality, and increase the risk of poor outcomes. Research has
shown that the ability of a provider to accurately diagnose a patient's
condition can be jeopardized by untrained interpreters, such as family
and friends, and especially minor children who are prone to omissions,
additions, substitutions, volunteered opinions, semantic errors, and
other problematic practices.\137\ Additionally, the use of children as
interpreters raises not only 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. 87 FR 47863.
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\137\ Joseph R. Betancourt et al., The Disparities Solutions
Ctr., Mongan Inst. for Health Pol'y, Mass. Gen. Hosp., Improving
Patient Safety Systems for Patients with Limited English
Proficiency: A Guide for Hospitals, pp. 3-5, 10-11, 14-16 (2012),
https://www.ahrq.gov/sites/default/files/publications/files/lepguide.pdf.
---------------------------------------------------------------------------
Comment: Some commenters requested that OCR provide emergency
exceptions for using bilingual/multilingual staff as interpreters.
These commenters noted that covered entities should be able to use
their staff's skills in different languages when needed in emergency
situations.
Response: We appreciate commenters' concerns regarding obtaining
the services of a qualified interpreter in emergency situations. Under
Sec. 92.201(e)(2) introductory text, a covered entity may ``[r]ely on
an adult, not qualified as an interpreter, accompanying a limited
English proficient individual to interpret or facilitate
communication'' as a temporary measure in an emergency pending the
retention of a qualified interpreter. OCR has revised Sec.
92.201(e)(2) introductory text to remove references limiting reliance
on a non-qualified interpreter to only an adult ``accompanying an
individual with LEP.'' This provision now allows for a covered entity
to rely on a bilingual/multilingual staff member--or other adult not
accompanying an individual with LEP--to serve as an interpreter as a
temporary measure in such emergency situations. Furthermore, the
interpreter services of bilingual/multilingual staff who are also
qualified interpreters may be utilized in any situation, including
emergency situations. However, covered entities should consider how to
obtain the services of a qualified interpreter as quickly as possible
in emergency and exigent circumstances, and only rely upon other
persons in highly exceptional circumstances.
Comment: A couple of commenters recommended that OCR revise Sec.
92.201(e)(2)(ii) to allow a covered entity to use a qualified
interpreter even in situations where the patient has requested that a
family member or friend interpret or facilitate communication. These
commenters explained that if a provider believes that the family member
or friend may not be accurately communicating with the patient or
appears to be struggling when interpreting or if a health provider
suspects in good faith that an individual may be a victim of
trafficking or abuse, then the health provider should be able to
utilize a qualified interpreter.
Another commenter recommended that OCR clarify that an accompanying
adult may only facilitate communication at the request of an individual
with LEP when the request is made in private, without the adult
present. The commenter expressed concern that the exception as written
could interfere with the autonomy of the individual with LEP seeking
sexual or reproductive health services, especially if the individual is
accompanied by an abusive partner that objects to certain sexual and
reproductive health services.
Additionally, one commenter noted that the prohibition of an
accompanying adult acting as an interpreter--absent the individual with
LEP's consent or in the case of an emergency--is particularly important
for survivors of domestic and sexual violence. The commenter stated
that without such a restriction, victims and survivors are faced with
situations where their abuser, child, or family member may be used to
interpret traumatic and sensitive information, compounding the risk to
victims and trauma to themselves as well as their children. Another
commenter recommended OCR specify that if an individual with LEP
requests an accompanying adult to facilitate one time, this does not
mean the covered entity can assume the individual with LEP will
continue to bring that same adult or choose to use that adult as an
interpreter for future interactions. The covered entity must offer
language services each and every time it encounters an individual with
LEP.
One commenter requested OCR also address nonemergency situations
where the patient does not ``specifically request'' that an
accompanying adult interpret or facilitate communication, but where,
despite best efforts to find a qualified interpreter, it is not
possible to find a qualified interpreter for the individual with LEP,
such as when a patient speaks a rare dialect of a language.
Response: We appreciate the commenters' concerns regarding when it
may or may not be appropriate to grant an adult with LEP's request for
an individual not qualified as an interpreter to interpret or
facilitate communication. When considering reliance on an accompanying
adult to interpret, the covered entity must consider whether that
reliance is appropriate--this includes whether the covered entity
believes the accompanying adult can adequately convey the information
being discussed and whether they may have a conflict or bias, as in the
case of intimate partner violence. Any agreement by a covered entity to
allow an accompanying adult to interpret or facilitate communication
may only be at the affirmative and independent request of the
individual with LEP so as to protect individuals in situations such as
intimate partner violence, abuse, or trafficking. We clarify that OCR
appreciates the critical role parents and guardians play in medical
decision-making for their children and that the rule does not prevent
parents from being involved in their children's health care decisions.
To address the concern of coercion and the like, we are finalizing
Sec. 92.201(e)(2)(ii) to include a requirement that the individual
with LEP make their request without the accompanying adult present and
with the services of a qualified interpreter, which does not include
the exigent circumstances exception found at Sec. 92.201(e)(2)(i).
Comment: One commenter encouraged OCR to include a specific
provision at Sec. 92.201(e) ensuring privacy and confidentiality for
individuals with LEP, such as not having sensitive discussions in
waiting rooms and other public spaces.
Response: We appreciate the commenter's concern regarding privacy
and confidentiality for individuals with
[[Page 37583]]
LEP and restate that one of the key components of the definition of
``qualified interpreter for an individual with limited English
proficiency'' is that they must adhere to generally accepted
interpreter ethics principles, including client confidentiality.
Additionally, covered entities that are subject to both HIPAA and
section 1557 must comply with the requirements of both laws.\138\
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\138\ Determining the relationship between the interpreter and
the covered entity is a covered entity's HIPAA obligation and is
unchanged by section 1557 or the part. We encourage covered entities
to review OCR's HIPAA Frequently Asked Questions (FAQ) regarding
business associates. See U.S. Health & Hum. Servs., Off. for Civil
Rts., Health Information Privacy FAQs, https://www.hhs.gov/hipaa/for-professionals/faq/760/must-a-covered-provider-obtain-individual-authorization-to-disclose-to-an-interpreter/index.html.
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Comment: Several commenters supported the restoration of
requirements related to video remote interpreting (VRI) for individuals
with LEP. Commenters noted that the 2020 Rule removed requirements
related to VRI for individuals with LEP, yet many covered entities use
video interpreting not only for deaf or hard of hearing patients but
also patients with LEP. Further, these commenters noted that the
quality of video interpreting should be the same for all individuals
who use it. A couple of commenters specifically noted the importance of
high-quality picture, video, and transmissible audio for all parties in
order for interpreters to perform their job effectively. For example,
one commenter noted the importance of restoring VRI standards for
individuals with LEP given frequent concerns about the poor quality of
interpreter services using VRI. A couple of other commenters mentioned
that the use of such technology will facilitate discussion between
qualified interpreters and individuals with LEP and will also assist
individuals who may have disabilities who are aided by using such
technology. One commenter, who supported inclusion of VRI standards,
recommended in-person interpretation should be sought as a first step
because it is more responsive than VRI.
Response: We agree with commenters that it is important to have
parity in VRI quality standards for all individuals who use it. The
final rule reinstates the VRI standards from the 2016 Rule, former 45
CFR 92.201(f), which were based on standards found in the implementing
regulations for title II of the ADA.\139\ This provision is designed to
achieve parity with the VRI requirements found in Sec. 92.202
regarding effective communication for people with disabilities.
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\139\ See 28 CFR 35.160(d)(1)-(4). In contrast to 28 CFR
35.160(d)(2), which regulates the size of the video image to ensure
that the screen shows one's face, arms, hands, and fingers, Sec.
92.201(f)(2) in this final rule does not regulate the size of the
video image because this component is less relevant for oral
interpretation between English and non-English languages or two non-
English spoken languages.
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We recognize that VRI is not always the most appropriate method for
providing language assistance services. This provision does not require
a covered entity to provide VRI but rather ensures that when such
services are used, they meet a minimum quality standard. To also
clarify that the language assistance services delivered via VRI must
provide meaningful access, we are revising Sec. 92.201(f) to require
that when a covered entity uses VRI services, it ``must ensure the
modality allows for meaningful access.''
Comment: A few commenters raised concerns with the proposed
technical requirements for VRI services. A couple of commenters
requested OCR provide emergency exceptions for performance standards
for video remote interpreting. These commenters also expressed concern
with the requirement that VRI must be over a dedicated high-speed,
wide-bandwidth video connection or wireless connection since it may be
difficult to meet that standard in an emergency, such as a natural
disaster that disrupts access to the high-speed connection.
Another commenter suggested revising the rule to require covered
entities to use audio and video communications for interpretation
services that are consistent with those available in the community
served by the health program or activity. The commenter explained the
communications framework in a community, such as a rural community, may
not fully meet the standards proposed.
Response: We appreciate commenters' concerns regarding the ability
to meet the VRI standards proposed. In the event of a natural disaster
or locations where high-speed wide-bandwidth video capabilities may not
be available, covered entities may not be able to meet the required
standards. In these circumstances, a reasonable step to achieving
meaningful access may be through using the services of a qualified
interpreter via telephone (or in-person, if available). As in all
circumstances, OCR will consider the specific facts of whether a
covered entity has taken reasonable steps to provide meaningful access
under the circumstances.
Comment: A couple of commenters recommended that VRI requirements
be reflective of and adaptable to the specific community or individual.
One organizational commenter recommended that the rule clarify that
covered entities should follow an individual's preference with respect
to interpreter services where appropriate. The commenter noted that the
majority of their members and patients with LEP communicate through
telephonic interpretation services and that there are also situations
where a member or patient may express a preference to use an audio
interpreter service rather than be required to participate in a video
session.
Response: We appreciate commenters' suggestions regarding
prioritizing an individual with LEP's preference when determining the
manner in which interpreting services will be provided. However, we
decline to revise the requirements for VRI standards. These standards
set minimum requirements for when language assistance services are
provided via VRI; they do not, however, require a covered entity to use
such technology. Covered entities are free to use audio-only
interpretation if that is a reasonable step to provide meaningful
access to an individual with LEP, including if it is the expressed
preference of an individual with LEP.
Comment: A few commenters recommended OCR establish further
requirements with respect to VRI. These commenters suggested OCR
specify that the covered entity should be held responsible for ensuring
that the VRI device connects to a qualified interpreter within five
minutes of the arrival of the VRI device in the room and ensure that
there are no interruptions in communication, such as disconnections or
screensavers. Further, commenters recommended that health care entities
should have personnel available on a 24-hour basis who are trained and
able to operate the VRI system efficiently. These commenters stressed
that hospitals are already responsible for the maintenance and upkeep
of multiple types of equipment necessary for health care and, as such,
the same strict standards for optimal operation and upkeep should apply
to VRI technology as well. A few commenters stated that covered
entities should have policies and procedures in place to procure video
remote interpretation.
Response: OCR appreciates the commenters' recommendations for
providing further requirements related to VRI. The rule requires that
language assistance services be provided in a timely manner. We decline
to mandate a specific time period in which an interpreter must be made
available once
[[Page 37584]]
a VRI device is present, as it does not allow for the necessary
flexibility that may be required to account for the specific
circumstances giving rise to the interaction, such as whether it is
scheduled or unscheduled. We agree it is important to ensure a covered
entity has personnel who can maintain and efficiently set up and
operate VRI technology. To this end, the rule requires covered entities
to maintain language access procedures per Sec. 92.8(d), and to
provide adequate training to users of the technology and other involved
persons so that they may quickly and efficiently set up and operate the
VRI device per Sec. 92.201(f)(4). Although we support covered entities
having policies and procedures in place related to the procurement of
video remote interpretation, we decline to require them to do so
because we do not believe imposing such a requirement is warranted at
this time.
Comment: OCR received a few comments on the standards for audio
remote interpreting services at Sec. 92.201(g), which were generally
supportive. One commenter expressed that audio-only interpretation is
often a poor substitute for video remote or in-person interpretation
and recommended OCR consider audio-only interpretation to be a last
resort.
Response: We appreciate the commenter's concern and recognize that
audio remote interpreting may not be adequate to provide meaningful
access to an individual with LEP. However, there are situations in
which audio remote interpreting may be the only option available to a
covered entity and so we decline to place further restrictions on its
use. To address concerns that audio remote interpreting may fail to
provide meaningful access, we are revising Sec. 92.201(g) to require
that when a covered entity uses audio remote interpreting services, it
``must ensure the modality allows for meaningful access.''
Comment: One commenter recommended OCR explicitly prohibit covered
entities from coercing individuals with LEP to decline language
assistance services, which was stated in the preamble to the 2015 NPRM.
80 FR 54185. The commenter noted that the 2022 NPRM did not capture
this important concept and covered entities should be prohibited from
discouraging individuals with LEP from exercising their rights, which
may be a form of discrimination.
Response: We appreciate the commenter's concern and reiterate that
a covered entity may not coerce an individual with LEP to decline
language assistance services. In the same way that a covered entity is
prohibited from requiring an individual with LEP to accept language
assistance services, Sec. 92.201(h), a covered entity similarly cannot
require or coerce an individual to decline such services.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, OCR is finalizing the provisions as proposed in
Sec. 92.201, with modifications. In Sec. 92.201(a), we are adding
``(including companions with limited English proficiency)'' after the
term ``individual with limited English proficiency.'' In Sec.
92.201(e)(2), we are deleting the clause ``accompanying a limited
English proficient individual.'' In Sec. 92.201(e)(2)(i), we are
replacing ``the accompanying adult'' with ``an initial adult
interpreter.'' In Sec. 92.201(e)(2)(ii) we are adding the phrase ``in
private with a qualified interpreter present and without an
accompanying adult present,'' after ``where the individual with limited
English proficiency specifically requests.'' In Sec. 92.201(f), we are
adding the phrase ``ensure the modality allows for meaningful access
and must . . .'' after ``through video remote interpreting services in
the covered entity's health programs and activities must . . .'' In
Sec. 92.201(g), we are adding the phrase ``ensure the modality allows
for meaningful access and must . . .'' after ``through audio remote
interpreting services in the covered entity's health programs and
activities must . . .''
We are also making technical revisions. Throughout Sec. 92.201, we
are replacing the term ``limited English proficient individual'' with
``individual with limited English proficiency.'' In Sec. 92.201(c)(2),
we are replacing the phrase ``a covered entity must use a qualified
translator'' with ``a covered entity must utilize the services of a
qualified translator.'' In Sec. 92.201(e)(2)(ii), we are replacing the
word ``the'' in the phrase ``by the accompanying adult is documented''
with ``by an accompanying adult is documented.'' In Sec. 92.201(e)(4)
we are striking the word ``directly'' as technically incorrect to
describe the manner in which a covered entity communicates to an
individual with LEP via the services of a qualified interpreter or
qualified translator.
Effective Communication for Individuals With Disabilities (Sec.
92.202)
Proposed Sec. 92.202 addressed requirements related to providing
effective communication for individuals with disabilities.
In Sec. 92.202(a), we proposed requiring 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.
In Sec. 92.202(b), we proposed to 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.
The comments and our responses regarding Sec. 92.202 are set forth
below.
Comment: While commenters generally expressed support for Sec.
92.202, many discussed the extensive lack of compliance with current
effective communication requirements under section 1557, section 504,
and title II of the ADA by covered entities. Some referenced costs as
the key issue, and one commenter stated that some providers have a
policy of only providing an interpreter if the cost is covered by the
patient's health insurance. Another commenter stated that even when the
State has a Medicaid billing code, the patients still are faced with
the burden of having to educate prospective providers about the
availability of the code and the provider's obligation to provide
auxiliary aids and services.
Other commenters mentioned that compliance will require
implementing programs to develop, maintain, and communicate clear
policies, and train on the provision of language assistance services
and auxiliary aids and services for effective communication.
Response: OCR is aware that some covered entities fail to comply
with their responsibility to ensure effective communication with
individuals with disabilities, including through requiring an
individual to bring their own interpreter, only providing interpreter
services when covered by the individual's health insurance coverage or
other health-related coverage, or incorrectly citing health privacy
laws as a reason to not provide interpreter services.
In an effort to proactively address compliance concerns and
resulting lack of access to covered health programs and activities, we
are requiring all covered entities to develop and
[[Page 37585]]
maintain effective communication procedures, per Sec. 92.8(e). OCR
encourages covered entities to include any necessary billing codes in
such procedures. We are further requiring covered entities to train
relevant employees on these procedures, per Sec. 92.9.
Comment: A patient advocacy group recommended requiring that states
establish a medical communication access fund that pools fees from
State-mandated medical licenses to pay for effective communication. The
commenter expressed that this method spreads out the costs of auxiliary
aids and services so that no single covered entity bears the costs.
Response: All covered entities must provide auxiliary aids and
services when needed to communicate effectively with people with
disabilities. OCR encourages covered entities to develop creative
approaches to support the provision of these required aids and
services. OCR declines to include a specific requirement for states to
establish mandatory medical communication access funds in this
rulemaking as such a requirement would exceed the authority granted to
OCR for this rulemaking.
Comment: Some commenters expressed appreciation and support for the
inclusion of ``companions'' in the text of Sec. 92.202. One commenter
added that doctors and hospitals have told patients that their legal
counsel informed them that they are not obligated to provide
communication access to anyone who is not a patient. One commenter
recommended that OCR include that the selection of ``appropriate''
companion(s) be made by the individual not the provider.
Response: Section 1557 requires that covered entities ensure
effective communication for individuals with disabilities, including
companions. The definition in Sec. 92.4 is consistent with the
definition of ``companion'' from the implementing regulations for title
II of the ADA, which similarly requires that a public entity ``take
appropriate steps to ensure that communications with . . . companions
with disabilities are as effective as communications with others.'' 28
CFR 35.160(a).
Comment: A couple of commenters mentioned that patients are
sometimes told that due to confidentiality they cannot have a friend,
family member, advocate, or attorney be present for an appointment for
effective communication purposes. One commenter provided the following
example: An individual with Autism Spectrum Disorder (ASD) was required
to enter the hospital without his mom, who could assist him in
communicating, and likely because of that he was misdiagnosed and
required to return to the emergency room within a week.
Response: Unless a covered entity has a specific confidentiality
concern regarding the presence of a specific companion, the individual
with a disability should be permitted to select a companion and have
them present when accessing a covered health program or activity.
Further, and consistent with instruction under the ADA, a companion may
need to help the patient with information or instructions given by
hospital personnel.\140\ Companions may be an essential part of
ensuring an individual with a disability is afforded effective
communication and should not be separated from an individual with a
disability outside of extenuating circumstances. However, we note that
a covered entity may not rely on a person accompanying an individual
with a disability to interpret or otherwise facilitate communication;
this is only permitted when the individual with a disability
specifically requests that an accompanying adult interpret or
facilitate communication, the accompanying adult agrees to provide such
assistance, and reliance on that adult for such assistance is
appropriate under the circumstances. See 28 CFR 35.160(c)(2)(ii),
incorporated by Sec. 92.202.
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\140\ 75 FR 56183, 56223-24 (Sept. 15, 2010).
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Comment: Several commenters thanked OCR for proposing to restore
the requirements for quality measures in VRI, while some raised
concerns regarding the appropriateness of VRI in various circumstances.
They shared that, for example, VRI may not be effective for a person
lying on their back for a medical procedure due to challenges with
viewing the screen and that VRI has been inappropriately used during
high-risk childbirth. Yet another commenter mentioned that VRI is not
appropriate for individuals who are deafblind (i.e., individuals who
have combined hearing and vision loss that limit access to both
auditory and visual information). One commenter expressed concern that
a provider made it a policy that their facility only uses VRI and never
uses the services of in-person interpreters.
Response: We acknowledge the concerns with VRI and note that it may
not provide effective communication for all individuals in all
situations. Covered entities are required to take appropriate steps to
ensure that communications with individuals with disabilities are as
effective as communications with individuals without disabilities in
their health programs and activities. If the use of VRI does not
provide an individual equal opportunity to participate in or benefit
from the service in question, then the communication is ineffective and
does not meet section 1557 requirements.
Several cases have found that VRI was ineffective due to hospital
staff's lack of knowledge about how to operate the VRI equipment or
technology issues with the equipment itself, including the attempted
use of VRI during labor.\141\ Settlement agreements with the United
States have similarly found concerns with VRI, including one settlement
decree that specified that VRI would not be considered effective in
specific situations, including situations due to: ``(1) a patient's
limited ability to move his or her head, hands or arms; vision or
cognitive issues; or significant pain; (2) space limitations in the
room; (3) the complexity of the medical issue; or (4) any other time
when there are indicators that VRI is not providing effective
communication.'' \142\
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\141\ Sunderland v. Bethesda Hosp., Inc., 686 F. App'x 807 (11th
Cir. 2017); Silva v. Baptist Health S. Fla., Inc., 303 F. Supp. 3d
1334 (S.D. Fla. 2018), aff'd in part, vacated in part, remanded, 838
F. App'x 376 (11th Cir. 2020); Juech v. Children's Hosp. & Health
Sys., Inc., 353 F. Supp. 3d 772 (E.D. Wis. 2018); Settlement
Agreement Between the United States of America and Floyd Medical
Center (2016), https://archive.ada.gov/floyd_sa.html; see also
Manako Yabe, Healthcare Providers' and Deaf Patients' Interpreting
Preferences for Critical Care and Non-Critical Care: Video Remote
Interpreting, 13.2 Disability and Health J. 100870 (2020), https://pubmed.ncbi.nlm.nih.gov/31791822/; Nat'l Ass'n for the Deaf, Minimum
Standards for Video Remote Interpreting Services in Medical
Settings, https://www.nad.org/about-us/position-statements/minimum-standards-for-video-remote-interpreting-services-in-medical-settings/.
\142\ Settlement Agreement Between the U.S. and Swedish Edmonds
Hospital (2014), https://archive.ada.gov/swedish_edmonds_sa.htm;
Settlement Agreement Between the U.S. and Grady Memorial Hospital
(2016), https://archive.ada.gov/grady_sa.html.
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This enforcement activity suggests that VRI may not always afford a
person with a disability an equal opportunity to participate in and
enjoy the benefits of the program or activity of a covered entity.
Thus, policies that require the exclusive use of VRI, or the exclusive
use of any particular auxiliary aid or service, are likely to result in
the eventual failure to provide effective communication and therefore
should not be adopted.
Comment: One patient advocacy group recommended that OCR emphasize
that family members should not act as interpreters for a deaf or hard
of hearing patient, except in certain exigent circumstances.
[[Page 37586]]
Response: Covered entities are responsible for providing effective
communication, including through utilizing the services of a qualified
interpreter, and cannot require an individual to bring someone to
interpret for them. Persons with disabilities can, however, bring an
interpreter of their choosing, including a family member, and OCR
declines to add the suggested language prohibiting this choice. This
approach is consistent with existing ADA title II regulations, 28 CFR
35.160(c), and with the approach OCR has followed in the section 504
proposed rule. 88 FR 63392, 63508 (Sept. 14, 2023) (proposed 45 CFR
84.77(c)(2)(ii)).
Comment: One group recommended that the final rule include language
that requires health care entities to consider a patient's preference
for gender of the interpreter as a means of ensuring more effective
communication. This group noted that given the intimate nature of
medical assessments and treatments, patients may not be comfortable
with an interpreter of a different gender than themselves, particularly
in settings that involve nudity such as in an obstetrics and gynecology
appointment.
Response: While OCR appreciates that a patient may prefer an
interpreter of a particular gender and recommends consideration of a
patient's preference for a particular gender whenever possible,
including when the request is made based on an individual's religious
practices and beliefs, we decline to include such language in the rule
regarding the gender of a qualified interpreter for an individual with
a disability. OCR notes that some organizations, such as the National
Association of the Deaf and Deaf Seniors of America, have issued
position statements to guide providers in adopting internal VRI
policies, and have stated that medical providers ``shall honor the
preference of the deaf or hard of hearing patient and/or companion with
respect to the gender of video interpreter.'' \143\ However, OCR notes
that whether a covered entity has ensured their communication is
effective for an individual with disability does not inherently depend
on whether the covered entity is able to satisfy a patient's preference
regarding the interpreter's gender.
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\143\ Nat'l Ass'n of the Deaf, Minimum Standards for Video
Remote Interpreting Services in Medical Settings, https://www.nad.org/about-us/position-statements/minimum-standards-for-video-remote-interpreting-services-in-medical-settings/.
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Comment: An organizational commenter said that providers should be
required to ``affirmatively ask'' patients what they need to make
documents accessible and should document that requirement so that it
does not need to be repeatedly asked and answered.
Response: OCR understands the frustration experienced by
individuals who have to inform their providers of their need to receive
communication in accessible formats multiple times. We note that the
Department has implemented a process by which Medicare beneficiaries
who are blind or have low vision can request Medicare Summary Notices
in an accessible format, and following the initial request, the
required accessible format will be the default format of the document
mailed to the beneficiary.\144\ We recognize this as a best practice,
and while we decline to require that such need be documented, we
encourage covered entities to implement such a practice in the written
effective communication procedures required under Sec. 92.8(e).
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\144\ Beneficiaries can find information on how to request
Medicare Summary Notices in accessible formats at Medicare.gov,
Accessibility & Nondiscrimination Notice, https://www.medicare.gov/about-us/accessibility-nondiscrimination-notice; see also 88 FR
22120, 22122 (April 12, 2023).
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Comment: Some organizational commenters urged OCR to incorporate
the following OCR guidance documents directly into the final
regulations, as well as all subsequent similar guidance, technical
assistance, and enforcement activities: enforcement efforts related to
support persons in hospital settings \145\ and Bulletin on Civil
Rights, HIPAA, and the Coronavirus Disease 2019.\146\
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\145\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
OCR Resolves Complaints after State of Connecticut and Private
Hospital Safeguard the Rights of Persons with Disabilities to Have
Reasonable Access to Support Persons in Hospital Settings During
COVID-19 (June 9, 2020), https://public3.pagefreezer.com/content/HHS.gov/31-12-2020T08:51/https://www.hhs.gov/about/news/2020/06/09/ocr-resolves-complaints-after-state-connecticut-private-hospital-safeguard-rights-persons.html.
\146\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
March 28, 2020 BULLETIN: Civil Rights, HIPAA, and the Coronavirus
Disease 2019 (COVID-19) (Mar. 28, 2020), https://www.hhs.gov/guidance/document/march-28-2020-bulletin-civil-rights-hipaa-and-coronavirus-disease-2019-covid-19.
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Response: OCR thanks commenters for their suggestion to incorporate
guidance and enforcement materials into the final rule. Guidance
documents advise members of the public how an agency understands its
legal authorities.\147\ Similarly, covered entities and others may be
able to look to OCR's enforcement to gain clarity regarding regulatory
requirements. As guidance, technical assistance, and enforcement
activities are constantly evolving, we decline to codify the referenced
materials in this rule.
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\147\ Kisor v. Wilkie, 139 S. Ct. 2400, 2420 (2019) (plurality
opinion) (quoting Perez v. Mortgage Bankers Ass'n, 575 U.S. 92, 97
(2015)).
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Comment: Multiple commenters, including organizations, recommended
that Sec. 92.202(b) explicitly parallel the language in Sec.
92.201(b) by stating that auxiliary aids and services must be provided
free of charge, be accurate and timely, and protect the privacy and the
independent decision-making of the individual with a disability. The
commenters noted that while this section adopts by reference 28 CFR
35.160 through 35.164 (ADA title II communication requirements), some
covered entities may simply read the regulatory language and note the
difference in language between Sec. Sec. 92.201 and 92.202. Noting
this difference, several commenters also requested that OCR develop
technical assistance materials on 28 CFR 35.160 through 35.164 in plain
language.
Response: Like multiple places in this regulation, the text of
Sec. 92.202 adopts ADA title II standards by reference, including the
requirements related to auxiliary aids and services. OCR appreciates
the concerns raised by commenters regarding the apparent lack of parity
between Sec. Sec. 92.201(b) and 92.202(b), and how this may lead to
confusion on behalf of covered entities and the public and may increase
the likelihood that individuals with disabilities may either not
receive or may be required to pay for auxiliary aids and services.
Therefore, in light of comments received and continued compliance
concerns, we are revising Sec. 92.202(b) as follows.
First, OCR is revising the text, consistent with 28 CFR
35.160(b)(1), to clarify that all individuals with disabilities must be
afforded appropriate auxiliary aids and services and an equal
opportunity to ``participate in and enjoy the benefits of'' the health
program or activity in question.
Further, OCR agrees with commenters that it is important that those
reading this regulation can immediately identify that appropriate
auxiliary aids and services must be provided free of charge. Some
commenters and our enforcement experience demonstrate that this
requirement, similar to that in the ADA and section 504, is not always
clear or adhered to by covered entities. Thus, OCR is adding a sentence
to Sec. 92.202(b) stating that auxiliary aids and services must be
provided free of charge. OCR notes that this is similar to the approach
taken in DOJ's implementing regulations for title II and title III of
the ADA, which forbid surcharges on persons with disabilities or groups
of persons with disabilities to
[[Page 37587]]
cover the provision of auxiliary aides and services. 28 CFR 35.130(f)
(title II), 36.301(c) (title III). For parity with 28 CFR 36.160(b)(2)
and 45 CFR 92.201(b), we are also revising the text to clarify that
auxiliary aids and services must be provided in accessible formats, in
a timely manner, and in such a way to protect the privacy and the
independence of the individual with a disability.
OCR appreciates commenters' suggestion to develop technical
assistance materials regarding effective communication under 28 CFR
35.130 and 35.160 through 35.164. These are regulations promulgated and
enforced by DOJ, and we will continue to coordinate and collaborate
with DOJ to develop technical assistance materials related to effective
communication requirements under our respective authorities.\148\
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\148\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Disability Resources for Effective Communication, https://www.hhs.gov/civil-rights/for-individuals/special-topics/hospitals-effective-communication/disability-resources-effective-communication/index.html; see also Medicaid.gov, Unwinding
Documents, https://www.medicaid.gov/resources-for-states/coronavirus-disease-2019-covid-19/unwinding-and-returning-regular-operations-after-covid-19/state-letters/index.html.
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Comment: A few organizational commenters argued that the provision
of auxiliary aids and services is necessary but not a sufficient tool
for avoiding and remedying effective communication discrimination. The
commenters said that individuals who cannot rely on natural speech for
effective communication require ``effective access to the robust
language-based alternative and augmentative communication they need to
express themselves and be understood.'' Another group said that OCR
should expand on the definition of ``auxiliary aids and services'' to
include plain language and screen reader capabilities.
Response: Covered entities are required take appropriate steps to
ensure effective communication. Though the provision of appropriate
auxiliary aids and services is addressed in Sec. 92.202(b), the
examples of auxiliary aids and services provided at Sec. 92.4
(Definitions) is non-exhaustive and covered entities may use additional
auxiliary aids and services to achieve effective communication.
Effective communication for patients with cognitive, neurological,
and psychiatric disabilities may require auxiliary aids and services or
strategies different from those employed with patients with other
disabilities. For example, while an individual who is deaf or hard of
hearing may require an ASL interpreter to effectively communicate with
a provider, an individual with a cognitive disability may require
additional time with the provider to ask questions and receive plain
language answers about a specific health care decision.
In addition, one type of auxiliary aid or service that may be
required is the acquisition or modification of equipment or devices,
including for augmentative and alternative communication, and the
provision of training and assistance to the individual with a
disability on how to use them. Augmentative and alternative
communications devices include, but are not limited to, speech
generating devices, single-message devices, computers, tablets,
smartphones, amplification devices, telecommunications devices, voice
amplifiers, artificial phonation devices, picture and symbol boards,
paper-based aids, and other equipment or devices used to compensate for
impairments to speech-language production or comprehension, including
spoken and written modes of communication. In some instances, the use
of augmentative and alternative communication is necessary for
individuals with certain disabilities that impair speech production and
comprehension to access vital health and human services programs and
activities. Often, the most effective way for recipients to ensure
effective communication is to provide training on the use of this
equipment.
Comment: A health care organization requested that this provision
should be modified to state that covered entities ``must make a
reasonable attempt'' to provide auxiliary aids and services, ``unless
the covered entity can demonstrate that providing such auxiliary aids
or services would fundamentally alter the nature of the service in
question or result in an undue burden, i.e., significant difficulty or
expense.''
Response: OCR declines to modify the standard for effective
communication, which requires that covered entities ensure that
communications with people with disabilities are as effective as
communications with others. The language on fundamental alteration or
undue burden related to the provision of communications, found in 28
CFR 35.164, is already adopted into this section by reference.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.202, with modification. We are revising Sec. 92.202(b) to
read: ``A covered entity must provide appropriate auxiliary aids and
services where necessary to afford individuals with disabilities an
equal opportunity to participate in, and enjoy the benefits of, the
health program or activity in question. Such auxiliary aids and
services must be provided free of charge, in accessible formats, in a
timely manner, and in such a way to protect the privacy and the
independence of the individual with a disability.''
Accessibility for Buildings and Facilities (Sec. 92.203)
In Sec. 92.203, we proposed adding 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 OCR's section 504 regulation. OCR also
proposed incorporating the identical language found in the 2020 Rule at
Sec. 92.103, except that the definitions for 1991 Americans with
Disabilities Act Standards for Accessible Design (1991 ADA Standards),
2010 ADA Standards for Accessible Design (2010 ADA Standards), and
Uniform Federal Accessibility Standards (UFAS), Public Law 90-480; 42
U.S.C. 4151 et seq., are now located in Sec. 92.4.
OCR also notes that the section 504 regulatory provisions
incorporated into subpart B in this regulation contain program
accessibility requirements that apply to existing facilities as well as
new construction and alterations. Title II of the ADA and section 504
require that covered entities operate their programs and activities so
that, when viewed in their entirety, they are readily accessible to
individuals with disabilities; neither statute has been interpreted to
require that each existing facility be made accessible.\149\ Nearly all
of the entities subject to the facility access requirements in the
final rule are also subject to facility access requirements under
section 504 and the ADA. Section 92.203 establishes specific
accessibility standards for new construction and alterations under
section 1557.
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\149\ See 28 CFR 35.150(a); 45 CFR 84.22(a); Bird v. Lewis &
Clark Coll., 303 F.3d 1015, 1021 (9th Cir. 2002) (``the central
inquiry [under the ADA and section 504] is whether the program, when
viewed in its entirety is readily accessible to and usable by
individuals with disabilities'').
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The comments and our responses regarding Sec. 92.203 are set forth
below.
Comment: Some commenters emphasized the importance of a
[[Page 37588]]
continued push towards universal compliance with the 2010 ADA
Standards. Many commenters also noted how critical it would be for OCR
to provide oversight to ensure that covered entities' buildings and
facilities come into compliance with the 2010 ADA Standards. These
commenters also noted that the uniform application of the 2010 ADA
Standards will also enable greater consistency among implementing
agencies.
Response: OCR appreciates the comments regarding the existing
standards and the push towards universal compliance with the 2010 ADA
Standards and will continue to retain the requirement that new
construction or alteration of buildings or facilities must comply with
the 2010 ADA Standards.
Comment: Some commenters did not support the incorporation of 45
CFR 84.23(c) at Sec. 92.101(b) because they stated it would allow
facilities to only conform with UFAS instead of the more recent 1991
ADA Standards or 2010 ADA Standards. They also expressed concern that
the application of the UFAS to new facilities would be outdated. These
commenters believe that the UFAS permits facilities to maintain
barriers that exclude people with disabilities that impact their
mobility or strength.
Response: OCR appreciates the commenters concerns regarding the
incorporation of the UFAS. However, this rule does not allow UFAS to be
used as the accessibility standard for new facilities. UFAS is only
used to determine if a building built before July 18, 2016, was
designed and constructed in accordance with the standards at the time.
Any alteration or addition of any building or facilities built after
July 18, 2016, must follow the 2010 ADA Standards.
Comment: Some commenters also recommend incorporating existing
standards relating to accessible Medical and Diagnostic Equipment (MDE)
that were developed by the U.S. Access Board. 82 FR 2810 (Jan. 9,
2017), codified at 36 CFR part 1195 (U.S. Access Board 2017 Standards
for MDE). Commenters also noted that the lack of access to MDE should
constitute both a discriminatory benefit design and network inadequacy.
Response: On September 14, 2023, OCR published a NPRM proposing
modifications to the implementing regulations for section 504. The NPRM
proposes adopting the U.S. Access Board 2017 Standards for MDE used by
recipients of Federal financial assistance to ensure accessibility for
patients with disabilities. 88 FR 63450-55, 63511 (proposed 45 CFR
84.92). OCR will continue to address accessible MDE in that rulemaking.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing the provisions as proposed in Sec. 92.203
with modification. We are making two technical corrections to add ``or
alteration'' after ``construction'' in Sec. 92.203(b) and (c) for
consistency with the description of the 2010 Standards elsewhere in the
provision. We have replaced the phrase ``and such facility was not
covered by the 1991 Standards or 2010 Standards'' in Sec. 92.203(c)
with ``and such facility would not have been required to conform with a
different accessibility standard under 28 CFR 35.151'' for clarity and
consistency. We have also added language clarifying the timeframes for
compliance with either the 2010 Standards or the UFAS standards for
existing facilities where construction or alteration was begun on or
after July 18, 2016, and on or before January 18, 2018, in conformance
with UFAS but the facility or part of the facility was not covered by
the 2010 Standards. That addition reads, ``If construction or
alteration was begun on or after July 18, 2016, and on or before
January 18, 2018, in conformance with UFAS, and the facility or part of
the facility was not covered by the 2010 Standards prior to July 18,
2016, then it shall be deemed to comply with this section requirements
of this section and with 45 CFR 84.23(a) and (b).''
Accessibility of Information and Communication Technology for
Individuals With Disabilities (Sec. 92.204)
Proposed Sec. 92.204 addressed the accessibility of information
and communication technology (ICT) for individuals with disabilities.
In Sec. 92.204(a), OCR proposed requiring 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.
In Sec. 92.204(b), OCR proposed requiring 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.
Given the crucial role that ICT can play for individuals with
disabilities accessing health programs and activities, OCR sought
comment 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
invited 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(a) and (b); 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.
The comments and our responses regarding Sec. 92.204 are set forth
below.
Comment: Many commenters, including civil rights groups, health
care organizations, and a group of Federal elected officials, expressed
general support for the ICT requirements for people with disabilities
in the Proposed Rule. Several commenters said they are concerned that
this section only focuses on accessibility for individuals with
disabilities, saying that this section should be applicable to all
individuals covered by section 1557. These commenters noted that
section 1557's nondiscrimination mandate guards against discrimination
on the basis of race, color, national origin, sex, and age, as well as
disability. Therefore, these commenters recommended that Sec. 92.204
provide that covered entities must ensure that their health programs or
activities provided through ICT are accessible to individuals on all
protected bases, not just disability.
Response: Section 92.204 prohibits discrimination based on
disability in health programs and activities provided through ICT
because individuals with certain disabilities are often unable to
access certain aspects of ICT when that ICT is not developed to be
accessible. For example, OCR has received complaints from people with
disabilities, including those who are blind or have low vision,
alleging that the ICT of covered entities is
[[Page 37589]]
inaccessible to them and not compatible with screen reader software,
resulting in a denial of access to health programs and activities.
While Sec. 92.204 addresses ICT accessibility issues for individuals
with disabilities, it does not limit the application of general
nondiscrimination principles found throughout section 1557 regulations
to the accessibility of health programs and activities offered through
ICT to other groups. Thus, the general prohibition against
discrimination set forth in Sec. 92.101(a) requires the accessibility
of health programs and activities offered through ICT, without
discrimination on the basis of race, color, national origin, sex, age,
or disability.
Comment: Several groups recommended adding that ``covered entities
must procure, design, maintain and use accessible ICT in all aspects of
providing health programs and activities'' to remind covered entities
that their civil rights obligations apply in procurements. One group
said that OCR should clarify that covered entities should be aware that
third-party providers of ICT are not directly covered by this
regulation, and that covered entities are obligated to ensure that they
procure ICT that is accessible. Several commenters suggested the use of
a Voluntary Product Accessibility Template,\150\ a document that
indicates compliance with section 508 standards,\151\ should be
completed by the third-party vendors.
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\150\ Section508.gov, Voluntary Product Accessibility Template
(VPAT), https://www.section508.gov/sell/vpat/.
\151\ 36 CFR part 1194, appendix A. Section 508 of the
Rehabilitation Act imposes accessibility requirements for
information and communication technology that Federal departments
and agencies develop, procure, maintain, or use.
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Response: Regardless of the method that a covered entity uses to
acquire ICT, the health programs and activities it provides through
that ICT must be accessible to individuals with disabilities. Due to
the increasing importance of ICT in the provision of health care,
health insurance coverage, and other health-related coverage, OCR will
continue to closely monitor this area. Both OCR and DOJ recently issued
NPRMs addressing the accessibility of web content and mobile apps used
by recipients of Federal financial assistance and public entities,
respectively.\152\ Those rulemakings provide greater clarity on
obligations to ensure that web content and mobile applications are
accessible.
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\152\ 88 FR 63392 (Sept. 14, 2023) (HHS) and 88 FR 51948 (Aug.
4, 2023) (DOJ).
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Comment: An organizational commenter asked OCR to provide more
guidance on what constitutes undue burden or fundamental alteration.
Response: This rulemaking does not create a different standard for
fundamental alteration or undue burden beyond the standards in section
504 and the ADA. As DOJ noted in its August 4, 2023 NPRM,
Nondiscrimination on the Basis of Disability; Accessibility of Web
Information and Services of State and Local Government Entities, there
are current undue burden and fundamental alteration limitations in the
ADA title II regulation that are familiar to public entities. 88 FR
51948, 51978. The current limitations are in the ADA title II
implementing regulation at 28 CFR 35.150(a)(3) (program accessibility)
and 35.164 (effective communication) for fundamental alteration and
undue burden limitations and 28 CFR 35.130(b)(7) (reasonable
modifications in policies, practices, or procedures) for fundamental
alteration limitations. DOJ also provides additional context for
fundamental alteration and undue burden on its ADA.gov website.\153\
Additionally, DOJ's technical assistance manual on title III of the ADA
provides guidance on what constitutes fundamental alteration and undue
burden for public accommodations under title III.\154\
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\153\ See U.S. Dep't of Justice, State and Local Governments,
https://www.ada.gov/topics/title-ii/.
\154\ See U.S. Dep't of Justice, ADA Title III Technical
Assistance Manual, https://www.ada.gov/resources/title-iii-manual/.
This guidance document on title III of the ADA defines fundamental
alteration as ``a modification that is so significant that it alters
the essential nature of the goods, services, facilities, privileges,
advantages, or accommodations offered.'' It defined undue burden as
a ``significant difficulty or expense'' that can be determined based
on the nature and cost of the action, the overall financial
resources of the site involved, geographical separateness, overall
financial resources of the parent entity, and the type of operation
of the parent entity.
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Comment: A professional association asked OCR to work with small,
independent, and under-resourced physician practices to ensure they
have the resources, tools, and financial assistance necessary to ensure
ICT accessibility for patients with disabilities.
Response: OCR will continue to develop technical assistance and
educational materials to assist covered entities' compliance with
section 1557 and this regulation. However, we are unable to provide
other resources or financial assistance to ensure ICT accessibility.
Comment: One organizational commenter said that OCR should provide
technical assistance to covered entities servicing populations with
digital inequities, such as populations of older adults that may not be
as digitally savvy or individuals who do not have stable internet
connections.
Response: OCR recognizes that many people lack internet
connectivity and may therefore be unable to access web-based tools and
resources provided by covered entities, and OCR encourages entities to
develop creative means to meet the needs of these individuals. However,
though this issue may raise civil rights concerns in some contexts, it
is outside the scope of this regulation.
Covered entities have general nondiscrimination obligations under
Sec. 92.101(a), including that a covered entity may not discriminate
based on age. Accordingly, covered entities that use web-based health
programs and activities must ensure that older adults are not denied
participation, denied benefits, or otherwise discriminated against in
the provision of those web-based health programs and activities. For
example, a covered entity may not decline to provide an electronic
appointment reminder to an older individual because of a stereotype
that older individuals may experience difficulties using such
technology.
Comment: One organizational commenter recommended extending the
full ICT requirements to recipients and State exchanges.
Response: Recipients and State Exchanges are required to comply
with both Sec. 92.204(a) and (b), per the text of the section.
Comment: Multiple commenters requested the explicit inclusion of
mobile applications within this section. They stated that it would spur
greater awareness among software developers of the need for fully
accessible mobile applications that are also compatible with mobile
devices and internet platforms. One organizational commenter warned
that there could be privacy concerns with certain mobile apps used for
substance use disorder treatment and recommended that OCR collaborate
with the Substance Abuse and Mental Health Services Administration
(SAMHSA) to determine if Federal privacy laws apply to mobile
application health information, and communicate that information to
consumers.
Response: OCR appreciates these comments. Mobile applications are a
form of information and communication technology and are explicitly
included in the regulatory text under Sec. 92.204(b); thus, to the
extent covered entities use mobile applications as part of their health
programs and activities they must be accessible for individuals with
disabilities. Though privacy protections are outside of the scope of
this rulemaking, OCR reminds commenters
[[Page 37590]]
that it has issued guidance on the application of the HIPAA Privacy,
Security, and Breach Notification Rules to mobile health apps.\155\
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\155\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Resources for Mobile Health Apps Developers, https://www.hhs.gov/hipaa/for-professionals/special-topics/health-apps/index.html; U.S.
Dep't of Health & Hum. Servs., Off. for Civil Rts., Protecting the
Privacy and Security of Your Health Information When Using Your
Personal Cell Phone or Tablet, https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.
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Comment: Many commenters recommended OCR require covered entities
to comply with specific accessibility standards, such as section 508
standards, the WCAG 2.0 standards, the WCAG 2.1 standards, or other
standards that provide equal or greater accessibility. Several
commenters, including organizations, recommended requiring covered
entities to comply over time with the latest WCAG as they are updated
by the Web Accessibility Initiative of the World Wide Web Consortium
(W3C). The commenters also said that a requirement to adhere to the
latest standards could offer a range of time for compliance, with
larger entities that have more resources being required to comply with
a new WCAG standard within a shorter timeline than smaller entities. A
technology company said that OCR should not establish a requirement to
conform to the latest standard, but rather a requirement to conform to
technical specifications that are proven and generally accepted for
achieving and maintaining reasonable levels of accessibility; currently
that is WCAG 2.1 levels A and AA.
Some organizational commenters suggested that OCR should
incorporate a functional, evergreen standard for accessibility that
will adapt to changes in technology and accessibility practices. Such a
standard would require the ICT to be perceivable, operable,
understandable, and robust, and ``enable individuals with disabilities
to access the same information as, to engage in the same interactions
as, to communicate and to be understood as effectively as, and to enjoy
the same services offered to other individuals with the same privacy,
same independence, and same ease of use as, individuals without
disabilities.''
Several commenters, including health care organizations, advocacy
groups, and a trade association, offered suggestions for the timeline
for compliance with new standards. These included 60 days, 12 months,
18 months, and 2 years. A health care organization recommended that OCR
only require initial compliance in fields that are ``critical to
utilizing telehealth services'' and that covered entities be required
to meet the minimum conformance levels of the two most recent versions
of the W3C guidelines.
Some commenters supported compliance with accessibility standards,
provided that OCR conducts real-world testing with successful results
across a variety of physician offices before requiring compliance. The
commenter also suggested that OCR work with the Office of the National
Coordinator for Health Information Technology and vendors to ensure
that compliance does not place an undue financial or administrative
burden on physician practices. Expressing concern about the cost of
compliance, a professional association requested an exemption for
businesses classified as small businesses by the Small Business
Administration.
A few commenters, including a trade association, health care
organizations, and health insurance entities, suggested that OCR
establish a safe harbor by which covered entities compliant with WCAG
2.1 Level AA are deemed in compliance with the section 1557
requirements. Other commenters argued that OCR should not establish a
safe harbor because compliance with a set of accessibility standards is
not necessarily evidence of compliance with accessibility requirements;
there may be ICT that meets published standards but remains
inaccessible. Another commenter said OCR should not establish a safe
harbor because the ADA, the Rehabilitation Act, and other Federal laws
must continue to provide standalone protections.
Response: OCR appreciates commenters' input on this important topic
but has decided not to adopt specific accessibility standards or a safe
harbor at this time. This is in part due to OCR and DOJ recently
publishing NPRMs proposing specific accessibility requirements for
section 504 and title II of the ADA, respectively.\156\ Those NPRMs
propose to require that recipients of Federal financial assistance and
public entities must ensure that their web content and mobile
applications comply with set accessibility standards. In this
rulemaking, OCR continues to require covered entities to ensure that
health programs and activities provided through ICT are accessible to
individuals with disabilities sufficient to provide equal access to the
health program or activity, unless doing so would impose undue
financial and administrative burdens or would result in a fundamental
alteration in the nature of the entity's health program or activity.
OCR strongly encourages covered entities that offer health programs and
activities through ICT to incorporate current WCAG standards as they
take steps to ensure that those programs and activities comply with
requirements of this regulation and other Federal civil rights laws.
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\156\ See 88 FR 63392 (Sept. 14, 2023) (section 504) and 88 FR
51948 (Aug. 4, 2023) (ADA title II).
---------------------------------------------------------------------------
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.204, without modifications.
Requirement To Make Reasonable Modifications (Sec. 92.205)
In Sec. 92.205, we proposed requiring 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. Section 92.205 is the same as Sec. 92.205 in the
2016 Rule and Sec. 92.105 in the 2020 Rule. The term ``reasonable
modifications'' will be interpreted as set forth in the regulation
implementing title II of the ADA at 28 CFR 35.130(b)(7), such that ``[a
covered entity] shall make reasonable modifications in policies,
practices, or procedures when the 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] service, program, or activity'' and ``[a
covered entity] is not required to provide a reasonable modification to
an individual who meets the definition of `disability' solely under the
`regarded as' prong of the definition of `disability' at Sec.
35.108(a)(1)(iii).''
The comment and our response regarding Sec. 92.205 are set forth
below.
Comment: One commenter urged OCR to strengthen the section by
adding language to clarify that a modification to add something that is
medically necessary for individuals with disabilities, or to eliminate
exclusions related to medically necessary services, are not considered
fundamental alterations to the nature of the health program.
Response: OCR appreciates the commenter's request for clarifying
language related to fundamental alterations. In promulgating this rule,
OCR cannot address how the requirements of section 1557 apply to every
scenario that may arise. OCR also
[[Page 37591]]
cannot state every modification that could result in a fundamental
alteration because determining whether a modification is a fundamental
alteration is a fact-specific process.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing the provisions as proposed in Sec. 92.205,
without modification.
Equal Program Access on the Basis of Sex (Sec. 92.206)
OCR proposed a section clarifying covered entities' obligation to
ensure equal access to their health programs and activities without
discrimination on the basis of sex.
In proposed Sec. 92.206(a), we described 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.
In proposed Sec. 92.206(b)(1) through (4), we clarified certain
types of discriminatory actions that would be prohibited for a covered
entity in its provision of access to health programs or activities.
In Sec. 92.206(b)(1), we proposed prohibiting a covered entity
from denying or limiting 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.
In Sec. 92.206(b)(2), we proposed prohibiting 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.
In Sec. 92.206(b)(3), we proposed prohibiting 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.
In Sec. 92.206(b)(4), we proposed prohibiting 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.
In Sec. 92.206(c), we proposed 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.
In Sec. 92.206(d), we proposed that the enumeration of specific
forms of discrimination in paragraph (b) does not limit the general
applicability of the prohibition in paragraph (a).
The comments and our responses regarding Sec. 92.206 are set forth
below.
Comment: Numerous commenters supported OCR's proposal to
specifically address equal access on the basis of sex in the final
rule. A supporter of the provision argued that patients who trust their
provider not to discriminate against them will share better
information, enabling better treatment. Some commenters specifically
requested this section be strengthened by including specific examples
of what constitutes discrimination based on sex characteristics.
Response: OCR agrees that open communication between a provider and
their patient is a bedrock of the provision of quality care, and that
cannot happen where the patient experiences or expects that they will
face discrimination by the provider. In addition, we note that the
question of whether prohibited discrimination has occurred is often
context specific and fact intensive, so it is difficult to provide
succinct examples of scenarios that would constitute prohibited
discrimination in each and every instance.
Comment: Commenters urged OCR to include specific language related
to reproductive health care and fertility treatments in Sec. Sec.
92.206 and 92.207. A few commenters urged OCR to specify the full range
of reproductive health care protected from discrimination under section
1557, including protections against discrimination based on
reproductive health decisions. A few commenters said the final rule
should make clear that section 1557 prohibits discrimination related to
maternity care, such as failing to provide accessible medical equipment
or transfer assistance, leaving wheelchair users unable to access care.
Another commenter opined that the final rule should make clear that
section 1557 prohibits discrimination relating to treating pregnancy
emergencies and complications, including termination of pregnancy,
miscarriage management, and other pregnancy outcomes.
Response: Matters related to reproductive health care, fertility,
pregnancy, family status, and maternity care are addressed in Sec.
92.208, and OCR refers commenters to that section. Covered entities
must ensure accessibility of their health programs and activities for
individuals with disabilities, which includes accessible equipment and
transfer assistance.
Comment: Some commenters argued that it would be more appropriate
to address the impacts of the Dobbs decision and protections against
discrimination on the basis of obtaining an abortion in Sec. 92.206
rather than in Sec. 92.208 (Prohibition on sex discrimination related
to marital, parental, or family status), because addressing abortion in
the section on marital, parental, or family discrimination could convey
that denying abortion care is only discriminatory in those contexts.
Conversely, many commenters expressed opposition to the inclusion
of termination of pregnancy within the scope of equal program access on
the basis of sex, primarily stating that the rule would force health
care professionals to perform abortions or deem their refusal to do so
discrimination.
Response: OCR appreciates commenters' feedback regarding the
addition of pregnancy or related conditions in Sec. 92.206 rather than
in Sec. 92.208. Based on a review of the totality of the comments,
additional language has not been added to Sec. 92.206, and we discuss
this issue further in Sec. 92.208. Further, the ACA itself provides
that ``[n]othing in this Act shall be construed to have any effect on
Federal laws regarding--(i) conscience protection; (ii) willingness or
refusal to provide abortion; and (iii) discrimination on the basis of
the willingness or refusal to provide, pay for, cover, or refer for
abortion or to provide or participate in training to provide
abortion.'' 42 U.S.C. 18023(c)(2)(A). OCR will comply with this
provision. For further discussion regarding a health care
professional's decision not to provide an abortion, including due to a
sincerely held religious belief or conscience objection to performing
the procedure, see Sec. Sec. 92.208 and 92.302.
Comment: Many commenters recommended that in addition to the
specific forms of discrimination based on gender identity, it is
important to include specific forms of reproductive health and
pregnancy-related care discrimination in Sec. 92.206(b). Many
commenters recommended incorporating a provision or provisions under
Sec. 92.206(b) to clarify that covered entities are prohibited from
denying or limiting services--or denying or limiting a health
professional's ability to provide services--based on a patient's
[[Page 37592]]
pregnancy or related conditions, including termination of pregnancy,
contraceptive use, miscarriage management, assisted reproduction,
fertility care, and pregnancy-related services. One of these commenters
recommended that the language of this provision not be limited to
reproductive or sexual ``health care decisions,'' as covered entities
also discriminate based on reproductive and sexual health histories
such as past experiences with sexual violence, which exist beyond the
realm of services and that including ``care'' here could limit how
covered entities understand this form of discrimination. Some
commenters also stated that failure to codify some of the most
prevalent forms of sex discrimination will directly undermine efforts
to implement proposed Sec. Sec. 92.101 and 92.206.
Response: OCR appreciates the recommendations regarding
discrimination based on pregnancy or related conditions, including the
request to provide additional examples, and directs commenters to the
discussion at Sec. 92.208. The rule does not include language related
to discrimination based on health care decisions. The rule is not so
limited--it prohibits discrimination in health programs and activities
generally. This includes discrimination on the basis of sex in the
context of health decisions or histories related to reproductive and
sexual health.
Comment: Many commenters supported Sec. 92.206 as important to
ensure access to necessary health services that might otherwise be
denied to people due to discrimination on the basis of sexual
orientation or gender identity, with many providing specific examples
of discrimination faced by LGBTQI+ individuals. Some
commenters recommended specifically addressing protections for
LGBTQI+ people seeking fertility treatments. A commenter
recommended that OCR consider adding a subsection to Sec. 92.206 or
Sec. 92.208 to discuss the prohibition of discrimination on the basis
of sexual orientation and gender identity in access to fertility
services, and provided examples of the numerous barriers that
LGBTQI+ individuals and same-sex couples face in accessing
this type of reproductive health care.
Response: Section 1557 and this rule prohibit discrimination on the
basis of sex, including sex characteristics, sexual orientation, and
gender identity, in health care access. Depending on the specific facts
at issue, barriers described may rise to the level of discrimination
and would be evaluated under this rule's general prohibition of
discrimination under Sec. 92.101(a)(1), to make a case-by-case
determination as to whether prohibited discrimination has occurred. In
general, OCR anticipates that if a covered entity elects to provide or
cover fertility services, but categorically denies them to same-sex
couples or to individuals on the basis of sexual orientation or gender
identity, such a denial of care or coverage may violate section 1557's
prohibition on sex discrimination. We decline to add such specific
language to the regulatory text as proposed.
Comment: Commenters recommended that OCR should add language to
Sec. 92.206(b) affirming that section 1557 prohibits covered entities
from denying, limiting access to, or otherwise placing special caps,
costs, or additional procedural requirements on medications or
treatments needed specifically by people with disabilities,
irrespective of whether those medications or treatments can also be
used to end or complicate pregnancies or fertility.
Response: We address special caps, costs, or additional procedural
requirements related to health insurance coverage and other health-
related coverage in Sec. 92.207, and direct commenters to that
section. A discussion of medications and treatments related to
pregnancy and fertility care is in Sec. 92.208.
Comment: Many commenters recommended including ``transgender
status'' in Sec. 92.206(b)(1), (2), and (4) because there have been
instances in which those seeking to permit discrimination against
transgender people have justified it by pressing distinctions between
transgender status and gender identity.
Response: As noted in the discussion for Sec. 92.101(a)(2), the
term ``gender identity'' necessarily encompasses transgender status and
the two terms are often used interchangeably.\157\ We decline to
enumerate the full range of identities protected under the term
``gender identity.''
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\157\ See, e.g., Bostock v. Clayton Cnty., Georgia, 590 U.S.
644, 658-59 (2020); Doe v. Mass. Dep't of Correction, No. CV 17-
12255-RGS, 2018 WL 2994403 (D. Mass. June 14, 2018); Whitaker v.
Kenosha Unified Sch. Dist. No. 1 Bd. of Educ., 858 F.3d 1034 (7th
Cir. 2017).
---------------------------------------------------------------------------
Comment: Multiple commenters expressed support for the rule's
prohibition on denying or limiting care on the basis of a patient's
assigned sex at birth, gender identity, or gender otherwise recorded at
Sec. 92.206(b)(2). A commenter expressed support for the rule's
prohibition on covered entities denying or limiting a clinician's
ability to provide clinically appropriate care when the failure to do
so would constitute discrimination.
Another commenter supported this provision, arguing that it is
necessary to ensure that specialists and providers who see LGBTQI+
patients every day do not experience retaliation for providing care.
Pointing to State legislative efforts seeking to restrict or ban
providers from offering safe and effective treatment to
LGBTQI+ patients, the commenter argued that such protections
are particularly important to alleviate providers' fears that they may
be subject to retaliation or loss of licensure for providing gender-
affirming care. Another commenter similarly argued that covered
entities sometimes discriminate against transgender patients by
prohibiting their providers from providing certain services.
Response: As noted in the Proposed Rule, 87 FR 47866, this
provision recognizes that prohibited discrimination may take the form
of restrictions on individual providers, such as attending physicians,
that have the effect of discriminating against patients. Where a
covered entity imposes such a restriction based on a patient's gender
identity or sex assigned at birth, the restriction may constitute
prohibited discrimination in violation of this rule, even if the form
that the restriction takes is a limitation on the ability of providers
to prescribe or provide care.
Regarding providers' fears that they may be subject to retaliation
by their employer or loss of licensure, this rule does not apply to
employment practices, as discussed in Sec. 92.2(b), but employees of
covered entities remain protected against retaliation as provided in
Sec. Sec. 92.303 and 92.304. Not all State licensure boards receive
Federal financial assistance from the Department; upon receipt of a
complaint against a licensure board, OCR would need to first determine
whether we have jurisdiction before commencing an investigation.
Also, we note that a health care provider's decision not to provide
any service due to a sincerely held religious belief or conscience
objection is discussed further in Sec. Sec. 92.208 and 92.302.
Comment: Many commenters suggested that Sec. 92.206(b)(2) would be
clearer if the following phrase was deleted because it is redundant:
``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.''
Response: OCR appreciates the suggestion and has considered it, but
we
[[Page 37593]]
will maintain the proposed language, as the phrase provides additional
explanation of what would constitute discrimination. As we noted in the
Proposed Rule, 87 FR 47866, this is modeled on the provision in the
title VI regulations that notes that certain discriminatory employment
practices may be prohibited to the extent that they result in
discrimination against program participants, even though the primary
objective of title VI is not to regulate employment practices. See 45
CFR 80.3(c)(3). Likewise, the phrase commenters propose deleting here
clarifies that these restrictions on providers are prohibited only
insofar as they result in discrimination against individuals on the
basis of sex in a covered health program or activity. This phrase is
necessary to establish a violation because a discriminatory act under
this rule is one in which the individual is excluded from, denied the
benefits of, or otherwise subjected to discrimination under a health
program or activity on the basis of sex.
Comment: A few commenters stated that it appears that Sec.
92.206(b)(2) is directly aimed at the United States Conference of
Catholic Bishops' Ethical and Religious Directives for Catholic Health
Care Services.\158\ These commenters recommended that OCR disavow this
provision and affirm support for the value of religiously affiliated
health care and the right of faith-based hospitals to operate in
accordance with their convictions.
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\158\ U.S. Conference of Catholic Bishops, Ethical and Religious
Directives for Catholic Health Care Services (6th ed. 2018), https://www.usccb.org/resources/ethical-religious-directives-catholic-health-service-sixth-edition-2016-06_0.pdf.
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Response: As stated throughout this preamble, OCR values the vital
role that faith-based hospitals and other health care providers and
systems play in our nation's health care system. With respect to
concerns about potential conflicts between provisions of the final rule
and individuals' or organizations' sincerely held religious beliefs, we
refer commenters to the discussion at Sec. 92.302. The aim of Sec.
92.206(b)(2) is to address discrimination that has a secondary effect
on the ability of individuals to participate meaningfully in and/or to
receive health care from a covered health program in a
nondiscriminatory manner. OCR did not, nor did it intend to, single out
any religious teachings and will respect all guarantees of Federal
religious freedom and conscience laws.
Comment: Commenters highlighted that transgender and nonbinary
people face unique discrimination in inpatient settings that are
separated by sex, particularly those that have only male and female
facilities available. These commenters noted that this results in
nonbinary people not having access to facilities consistent with their
gender identity.
A few commenters raised concerns about the application of Sec.
92.206(b)(3) to arrangements and practices involving patients who share
intimate space with, or require intimate personal assistance from,
other individuals. The commenters argued that the requirement to treat
individuals consistent with their gender identity may raise concerns
for privacy.
Response: OCR appreciates the commenters' feedback. As specified in
the preamble discussion for Sec. 92.101, this final rule protects all
people regardless of gender identity, including transgender and
nonbinary people. Nothing in this rule prohibits a covered entity from
operating sex separated programs and facilities, so long as it does not
subject anyone, including transgender and nonbinary individuals, to
more than de minimis harm on the basis of sex. When a nonbinary
individual seeks participation in a single-sex health program or
activity or a health program or activity that maintains sex separate
facilities, the covered entity should work with that individual to
determine where they will best be served and where they can benefit the
most from the health program or activity without experiencing trauma,
distress, or threats to their safety due to an incorrect placement. A
covered entity must not deny a nonbinary individual access to a health
program or facility on the basis that the program or facility separates
patients based on sex or offers separate male and female programs or
facilities.
Courts have held that all individuals' safety and privacy can be
protected without also excluding transgender individuals from accessing
sex-separate facilities and activities consistent with their gender
identity.\159\ Nothing in the rule prevents covered entities from
implementing policies or procedures to preserve any patient's privacy--
consistent with the requirements of this rule and any other applicable
laws. Providers have a range of tools at their disposal to accommodate
individuals' privacy concerns and patient interests in a
nondiscriminatory manner. For example, a provider generally may
accommodate a patient's preferences about roommate assignments. A
covered entity will be in violation of this rule if they refuse to
admit a transgender person for care or refuse to place them in
facilities consistent with their gender identity, because doing so
would result in more than de minimis harm. We also note that no
application of this rule shall be required insofar as it would violate
Federal religious freedom and conscience laws. Recipients may rely on
those protections directly, see Sec. 92.3(c), or they may seek an
assurance of a religious freedom or conscience exemption, see Sec.
92.302(b).
---------------------------------------------------------------------------
\159\ Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d 586, 613-15
(4th Cir. 2020); see also Cruzan v. Special Sch. Dist. # 1, 294 F.3d
981, 984 (8th Cir. 2002) (per curiam) (holding that transgender
woman's mere presence in a sex-separate space did not constitute
actionable sexual harassment of her female co-workers); Whitaker v.
Kenosha Unified Sch. Dist. No. 1 Bd. of Educ., 858 F.3d 1034, 1052-
53 (7th Cir. 2017).
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Comment: A commenter opposed the rule on the grounds that it would
violate the U.S. Constitution's Equal Protection Clause standard for
sex discrimination claims, which the commenter asserted allows men and
women to be treated differently based on inherent differences in
biology when such differences are real and not based on stereotypes.
The commenter argued that proposed Sec. 92.206(b)(3) would
inappropriately prohibit providers from using any sex-based distinction
unless they can prove it does not cause more than de minimis harm. This
commenter alleged that the true purpose of such a provision is not
equal treatment for all patients but special treatment for transgender
individuals, particularly with respect to the use of sex-separate
facilities. This commenter also argued that the provision would
contradict the Voluntary Resolution Agreement the Department entered
into with Michigan State University (MSU) under section 1557, which
requires the presence of a chaperone--the sex of whom should be
determined by the wishes and comfort of the patient--for all sensitive
examinations.\160\
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\160\ See Voluntary Resolution Agreement between U.S. Dep't of
Health & Hum. Servs., Off. for Civil Rights & The Bd. of Trs. of
Mich. State Univ., dba Mich. State Univ. & MSU HealthTeam & MSU
Health Care, Inc. (2019), https://www.hhs.gov/sites/default/files/vra-between-msu-and-ocr.pdf.
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Response: Not all differential treatment on the basis of sex
constitutes unlawful discrimination under section 1557, and the final
rule does not prohibit all differential treatment.\161\ If a
[[Page 37594]]
sex-based distinction has only a de minimis impact, it is not
prohibited discrimination.\162\ But treating individuals differently on
the basis of sex constitutes sex discrimination where it imposes a
more-than-de minimis level of harm. Under the rule, providers may use
sex-based distinctions to administer individualized care, provided
those distinctions do not cause more than de minimis harm.
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\161\ Several courts have held that discrimination against
transgender people constitutes sex discrimination under the Equal
Protection Clause. See, e.g., Hecox v. Little, Nos. 20-35813, 20-
35815, 2023 WL 5283127, at *12 (9th Cir. Aug. 17, 2023); Brandt v.
Rutledge, 551 F. Supp. 3d 882, 889 (E.D. Ark. 2021), aff'd sub nom.
Brandt ex rel. Brandt v. Rutledge, 47 F.4th 661, 670 (8th Cir.
2022); Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d 586, 608 (4th
Cir. 2020); Whitaker by Whitaker v. Kenosha Unified Sch. Dist. No. 1
Bd. of Educ., 858 F.3d 1034, 1048 (7th Cir. 2017), abrogated on
other grounds as recognized by Ill. Republican Party v. Pritzker,
973 F.3d 760, 762 (7th Cir. 2020); Glenn v. Brumby, 663 F.3d 1312,
1316 (11th Cir. 2011); Smith v. City of Salem, 378 F.3d 566, 572,
577 (6th Cir. 2004); but see L. W. by & through Williams v.
Skrmetti, 83 F.4th 460 (6th Cir. 2023).
\162\ 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.'').
---------------------------------------------------------------------------
We disagree with the proposition that purpose of Sec. 92.206(b)(3)
is special treatment for transgender individuals, particularly with
respect to the use of sex-specific facilities. The purpose of this
section is to prevent unlawful discrimination on the basis of sex. The
prevention of discrimination on the basis of gender identity is an
important government objective that is substantially achieved by this
rule.
Further, the Voluntary Resolution Agreement entered into with MSU,
provides that a patient may request a chaperone to be present at any
time and that the patient's ``wishes and comfort should determine the
sex of the chaperone.'' \163\ It further specifies that MSU ``shall
accommodate, to the extent practicable, the Patient's request for a
same-sex chaperone.'' \164\ The final rule does not prohibit patients
from requesting or receiving a chaperone of the sex of their choosing.
---------------------------------------------------------------------------
\163\ MSU Agreement at IV.D.1.v.
\164\ MSU Agreement at IV.D.1.vi.
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Finally, OCR disagrees with the commenter that the rule violates
the Equal Protection Clause. OCR's authority to promulgate this rule
stems from a Federal non-discrimination statute, section 1557. This
rule does not purport to interpret the Equal Protection Clause. Thus,
even assuming the commenter is correct that the rule bans certain sex-
based distinctions that would be permitted under the Equal Protection
Clause, such a discrepancy would not mean the rule is unlawful. OCR may
promulgate a rule that imposes different non-discrimination
requirements on recipients of Federal funds than the non-discrimination
requirements the Equal Protection Clause imposes on the
government.\165\
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\165\ Cf. Fitzgerald v. Barnstable Sch. Comm., 555 U.S. 246, 257
(2009) (recognizing that the liability standards under title IX and
the Equal Protection Clause ``may not be wholly congruent'').
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Comment: A health research organization expressed support regarding
Sec. 92.206(b)(3)'s discussion of the impact on health research and
clinical trials. The commenter commended OCR on its guidance on sex-
specific health research. This commenter stated that the standard for
limiting research outlined by OCR in the 2022 NPRM was reasonable and
health researchers will typically be able to demonstrate the requisite
justification for a sex-specific research project or clinical trial
based on research protocols. However, the commenter requested OCR
provide similar guidance for the final rule on whether health research
protocols that target or exclude individuals with disabilities would be
considered discriminatory.
Conversely, another organizational commenter disagreed with the
statement on sex-specific clinical trials because the commenter
believed it would pressure clinical researchers and organizations to
disregard sex-based distinctions for fear of inviting a gender identity
discrimination claim. The commenter claimed that the rule would
contradict National Institutes of Health (NIH)'s expectation for
clinical trials, which the commenter claimed required specifying the
``biological sex'' of subjects, by laying down an ``unscientific
marker'' that sex-specific clinical trials can only be justified in
limited circumstances.\166\ The commenter further argued that this
would represent a backward step for women's health, because the
evaluation of diseases and treatments improved when researchers
recognized that sex must be taken into account as a biological variable
in medicine.
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\166\ The commenter does not provide a citation when making this
statement; however earlier in their comment, the commenter cites a
Notice from the National Institutes of Health (NIH): U.S. Dep't of
Health & Hum. Servs., Nat'l Inst. of Health, Consideration of Sex as
a Biological Variable in NIH-funded Research, NOT-OD-15-102 (June 9,
2015), https://grants.nih.gov/grants/guide/notice-files/not-od-15-102.html.
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Response: OCR appreciates these comments regarding the application
of this provision to sex-specific health research and clinical trials
and the standard proposed for evaluating claims of discrimination in
such health programs and activities. We agree that researchers should
not have challenges showing necessary justifications for
nondiscriminatory research distinctions grounded in a participant's
reproductive, anatomical, and genetic characteristics.
We disagree with the proposition that OCR is disregarding sex-based
distinctions in medicine. Health research and clinical trial protocols
are not prohibited from specifying an individual's sex consistent with
their reproductive, anatomical, and genetic characteristics, where
those characteristics are relevant to the clinical trial. However,
there are ways in which health research and protocols may result in
discrimination, such as disallowing participation based on gender
identity rather than on the basis of scientific requirement of the
research.
Should the need arise, OCR will consider issuing guidance on the
impacts of disability protections on research participation.
Comment: Several commenters supported the rule's prohibition on
sex-specific health programs or activities that subject any individual
to more than de minimis harm. One supportive commenter argued that this
approach recognizes harm as the primary measure of discrimination and
creates flexibility to identify new forms of harm, and another argued
the standard of no more than de minimis harm is consistent with
applicable case law, including Bostock. A commenter expressed
appreciation for the Proposed Rule's detailed explanation of de minimis
harm and the difference between clinical care for a patient.
Conversely, another commenter stated the Proposed Rule ``cherry
picks'' a title IX court decision to justify a standard of ``more than
de minimis harm'' as the basis for ``adjudicating gender identity,''
arguing that title IX has never required sex to be recognized as
anything but ``objectively, biologically based.'' Similarly, another
commenter argued the rule applies beyond denial or limitations on
health services. The commenter argued that the rule would prohibit
health care professionals, medical facilities, and insurance companies
from using any sex-based distinction unless they can prove it does not
cause more than de minimis harm, and that if a provider asks the wrong
question or asks an appropriate question in the wrong manner then the
provider will likely face a claim of discrimination on the basis of
gender identity.
Response: OCR appreciates the range of comments provided on the
proposed language regarding de minimis harm, and after careful review,
OCR is finalizing the language as proposed. The rule does not prohibit
all sex-based distinctions in health programs or activities, nor does
it broadly prohibit any policy or practice of treating
[[Page 37595]]
individuals differently based on sex. As noted in the Proposed Rule,
although intentional differential treatment on the basis of sex would
generally be considered prohibited discrimination, separation by sex or
differential treatment on the basis of sex is permissible under section
1557 where it does not cause more than de minimis harm. 87 FR 47866.
This distinction generally allows for sex-specific clinical trials when
sex is relevant to the trial, for example, while still prohibiting
differential treatment that causes harm.
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 and this rule does not prohibit or
inhibit that. 87 FR 47867-68. Such inquiries are not per se
discriminatory, even where they touch on intimate or sensitive matters.
For example, it is not discriminatory 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. Similarly, when providing
appropriate care to a patient, asking medically relevant questions
about a patient's anatomy or medical history in a way that causes
inadvertent distress--on its own--would not violate section 1557.
However, it is important to note that if such questions are not
relevant to assessing the patient's condition, or the patient has
answered the questions and makes clear that further questions are
unwelcome, the inquiries may rise to the level of harassment on the
basis of sex. For example, if the conduct is so severe or pervasive
that it denies a patient access to medical care, it would no longer be
permissible. OCR will evaluate these types of harassment claims on a
case-by-case basis to determine whether the alleged harassment was
``sufficiently severe, pervasive, and objectively offensive,'' to meet
the standards for discriminatory harassment.\167\
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\167\ Cf. Davis by Next Friend LaShonda D. v. Monroe Cnty. Bd.
of Educ., 526 U.S. 629, 650 (1999) (Under title IX, discriminatory
harassment must be ``severe, pervasive, and objectively
offensive'').
---------------------------------------------------------------------------
In response to commenters that questioned the legal basis for our
de minimis standard, we discussed in the 2022 NPRM, 87 FR 47866, n.
412, that sex-based distinctions that have only de minimis impact are
not the type of discrimination that Congress envisioned.\168\
---------------------------------------------------------------------------
\168\ See also Elborough v. Evansville Cmty. Sch. Dist., 636 F.
Supp. 2d 812, 820-21 (W.D. Wis. 2009) (noting that Title IX does not
``authorize[ ]lawsuits for damages in all cases of differential
treatment, no matter how isolated or minimal. The maxim that `the
law doesn't concern itself with trifles' applies to civil rights
cases as it does to any other case.'').
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Comment: A commenter recommended that, based on existing racial
disparities in maternal health and overall poor maternal health
outcomes in the United States, Sec. 92.206(b)(3) be amended to specify
that harm exceeding the threshold of de minimis harm with respect to
pregnancy and maternal health can include policies or practices that
subject people to rough handling, harsh language, undertreatment of
pain or pregnancy-related conditions, or other discriminatory
mistreatment during childbirth or the prenatal or postpartum periods.
Response: OCR recognizes that there is ample research demonstrating
the significant racial disparities in maternal health outcomes.\169\
Section 92.206(b)(3) specifically addresses different treatment on the
basis of sex, such as through sex-separate health programs and
activities. Depending on the specific facts at issue, the treatment
described by the commenter may rise to the level of discrimination and
would be evaluated under this rule's general prohibition of
discrimination under Sec. 92.101.
---------------------------------------------------------------------------
\169\ Donna L. Hoyert, U.S. Dep't of Health & Hum. 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;
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.
---------------------------------------------------------------------------
Comment: An organizational commenter strongly supported the
additional guidance provided by proposed Sec. Sec. 92.206 and 92.207
and noted that the forms of discrimination highlighted in proposed
Sec. Sec. 92.206(b)(3) and (4) and 92.207(b)(3) through (5), in
particular, affect many intersex people.
Response: OCR appreciates the commenter's feedback regarding the
discrimination addressed in Sec. Sec. 92.206(b)(3) and (4) and
92.207(b)(3) through (5) affecting intersex people as well. This final
rule makes explicit in regulatory text that sex discrimination includes
discrimination based on sex characteristics, including intersex traits,
as reflected in Sec. 92.101(a)(2).
Comment: Many commenters expressed support for the proposed
provisions related to gender-affirming care at Sec. 92.206(b)(4).
These commenters stated that such care can be critical to the well-
being of transgender and nonbinary people, and that accessing such care
can reduce the risk of negative physical and mental health outcomes
associated with gender dysphoria. Commenters discussed the negative
impact of widespread health care discrimination against transgender
people, stating that transgender people of color and transgender people
with disabilities are at particularly high risk of discrimination and
associated harms.
Response: OCR appreciates these comments and agrees that the
nondiscrimination protections are important to transgender and
nonbinary people's ability to access clinically appropriate care,
especially those who may face elevated risk of harm due to
discrimination on multiple protected bases.
In determining whether a covered entity violated section 1557 by
denying or limiting a health service sought for the purpose of gender-
affirming care, OCR will continue to consider evidence that the covered
entity would provide that same service for other purposes. Evidence
that OCR may consider to establish that the type of care is ordinarily
provided could include, among other things, statements by the provider,
information showing that the provider has provided similar care in the
past, or documentation regarding the provider's scope of practice.
Where there is other evidence that the covered entity has subjected
the individual to differential treatment on the basis of sex apart from
the denial of care itself, OCR may investigate and make a case-by-case
determination as to whether prohibited discrimination has occurred.
Comment: A few commenters stated that OCR is explicitly asserting
that it has authority under section 1557 to regulate the practice of
medicine according to its own determination of what is appropriate and
non-discriminatory care, along with authority to definitively determine
what is the current standard of medical care. Some commenters requested
OCR amend the provision to specify that care standards cannot facially
discriminate or otherwise result in discrimination based on a protected
characteristic, such that covered entities cannot mask discrimination
behind clinical policies or criteria.
Response: Section 1557 prohibits discrimination on certain
prohibited bases, and does not (and cannot) require a specific standard
of care or course of treatment for any individual or otherwise
interfere with individualized clinical judgment about the appropriate
course of care for a patient. OCR has a general practice of deferring
to a clinician's judgment about whether a particular service is
medically appropriate for an individual, or
[[Page 37596]]
whether the clinician has the appropriate expertise to provide care.
There is no part of section 1557 that compels clinicians to provide a
service that they do not believe is medically appropriate for a patient
or that they are not qualified to provide.
Section 92.206(c) is consistent with the general principle in
nondiscrimination law that entities facing allegations of
discrimination have the opportunity to articulate a legitimate,
nondiscriminatory basis for their challenged action or practice but
that such a basis may not be a pretext for discrimination.
Comment: Some commenters expressed concern that OCR is setting
standards of care for gender-affirming care in this rule, and that is
outside the scope of OCR's authority. Many commenters weighed in with
their views on the state of medical evidence relating to gender-
affirming care and submitted citations to research studies and other
data. Some comments characterized the evidence as lacking or mixed, and
highlighted their concerns relating to gender-affirming care for
minors. Others stated that there is robust evidence, including from
major medical associations, supporting the provision of gender-
affirming care, including that such medically necessary care benefits
the health and well-being of transgender patients.
Response: This final rule prohibits discrimination on the basis of
sex, consistent with Federal law. As such, nothing in this rule impedes
covered entities from taking nondiscriminatory actions based on current
medical standards and evidence, such as making decisions about the
timing or type of protocols appropriate for care. The rule does not
(and cannot) require a specific standard of care or course of treatment
for any individual, minor or adult. Section 1557 prohibits
discrimination on certain prohibited bases, and does not interfere with
individualized clinical judgment about the appropriate course of care
for a patient. OCR has a general practice of deferring to a clinician's
judgment about whether a particular service is medically appropriate
for an individual, or whether the clinician has the appropriate
expertise to provide care.
Comment: A number of commenters had concerns or questions about the
scope of how OCR would define gender-affirming care. Some commenters
requested a definition or an enumeration of what types of procedures
would fall within this term. Others raised concerns about the impact of
such care and the benefits of such care.
Response: As with the 2016 Rule, 81 FR 31435, OCR declines to
provide a regulatory definition for gender-affirming care. However,
when we used the term ``gender-affirming care'' in both Sec. Sec.
92.206 and 92.207, we are generally referring to care designed to treat
gender dysphoria that may include, but is not necessarily limited to,
counseling, hormone therapy, surgery, and other related services. 87 FR
47834 n.139. As noted elsewhere, the rule does not impose a categorical
requirement that covered entities must provide gender-affirming care.
Further, while we acknowledge comments in support of and opposed to
gender affirming care and its subsequent impacts on individuals, we are
not making any additional edits to the rule in response.
Comment: Some commenters opposing the rule raised First Amendment
concerns and questioned the scope of what would be required of
providers in terms of expressing support of transgender people who wish
to access gender-affirming care, using the name and pronouns requested
by patients, and speaking about gender-affirming care.
Response: OCR takes seriously concerns about, and is fully
committed to upholding, the First Amendment, and nothing in these
regulations restricts conduct protected by the First Amendment.\170\
Whether discrimination is unlawful or considered harassment is
necessarily fact-specific. This final rule does not purport to identify
all of the circumstances that could constitute unlawful harassment. It
is unlikely that an isolated incident with no other indications of
animus or ill treatment would meet the standards for discriminatory
harassment. Conversely, OCR notes that conduct, including verbal
harassment, that is so severe or pervasive that it creates a hostile
environment on the basis of sex is a form of sex discrimination.
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\170\ See, e.g., W. Va. State Bd. of Educ. v. Barnette, 319 U.S.
624, 642 (1943) (``We think the action of the local authorities in
compelling the flag salute and pledge transcends constitutional
limitations on their power and invades the sphere of intellect and
spirit which it is the purpose of the First Amendment to our
Constitution to reserve from all official control.'').
---------------------------------------------------------------------------
Comment: A few commenters argued that providing gender-affirming
care poses high malpractice lawsuit risks to providers, and therefore
OCR should not categorically require providers to provide such
services.
Response: As discussed elsewhere in this preamble, this final rule
prohibits discrimination in the provision of health programs and
activities and does not require provision of any specific services,
including gender-affirming care. Section 1557 prohibits discrimination
on certain prohibited bases, and does not interfere with individualized
clinical judgment about the appropriate course of care for a patient.
OCR has a general practice of deferring to a clinician's judgment about
whether a particular service is medically appropriate for an
individual, or whether the clinician has the appropriate expertise to
provide care.
Comment: One commenter expressed concern that the rule would result
in decreased access to health care, as providers may choose to leave
Federal health care programs based on a belief that they will be
required to provide gender-affirming care, especially if there is no
avenue for providers with religious or conscience objections to certain
types of care to request exemptions.
Response: Section 1557 requires that health care providers who
receive Federal financial assistance must provide nondiscriminatory
care. However, providers do not have an affirmative obligation to offer
any health care, including gender-affirming care, that they do not
think is clinically appropriate or if religious freedom and conscience
protections apply. OCR believes that the majority of providers already
provide nondiscriminatory care to their patients and will continue to
do so. This commenter presented no evidence that a significant exodus
of providers is likely, and we are not aware of any data to support a
significant concern on this front. Providers with religious freedom or
conscience concerns, however, may rely upon Sec. Sec. 92.3 and 92.302.
Comment: A few commenters expressed support for nondiscrimination
protections that prohibited discriminating against an individual
because of their gender identity but opposed interpreting such
protections to protect access to gender-affirming care.
Response: OCR appreciates these commenters' support for the rule's
nondiscrimination protections on the basis of gender identity. We
respectfully disagree, however, that such protections have no
implications for the provision of gender-affirming care. A fact-
specific analysis is necessary to determine whether prohibited
discrimination has occurred, but the rejection of a practice closely
linked with a protected status may, in conjunction with other evidence,
lead to a finding of discrimination. This rule does not require or
mandate the provision of any particular medical service. Section 1557
prohibits discrimination on certain prohibited bases, and does not
interfere
[[Page 37597]]
with individualized clinical judgment about the appropriate course of
care for a patient. OCR has a general practice of deferring to a
clinician's judgment about whether a particular service is medically
appropriate for an individual, or whether the clinician has the
appropriate expertise to provide care.
Comment: An organizational commenter supported reference to the
multi-factor test found in Arlington Heights v. Metro. Housing Dev.
Corp., 429 U.S. 252 (1977), and the burden-shifting framework of
McDonnell Douglas Corp. v. Green, 411 U.S. 792 (1973), among a non-
exhaustive list of tools that OCR may utilize for investigating
discrimination claims. The commenter asserted that sex discrimination
claims are hard to prove, and that together these approaches are
appropriate for their adjudication by allowing people to rely on
different types of circumstantial evidence to collectively demonstrate
a discriminatory act by a covered entity and by placing the onus on the
covered entity to provide a legitimate, nondiscriminatory reason for
its actions. Similarly, another commenter encouraged OCR to clearly
state in the final rule that the familiar but-for causation test
applies to establishing a violation of section 1557; that the use of
the phrase ``legitimate, nondiscriminatory reason'' in these sections
should not be construed in any way to limit the method of proof for any
section 1557 claim to the McDonnell Douglas burden-shifting framework;
and that this method cannot be used to defend an express sex-based
classification that causes injury. Another commenter recommended that
OCR clarify in the preamble to the final rule that the McDonnell
Douglas burden-shifting framework and legitimate non-discriminatory
reason framework apply to circumstantial evidence cases but not where
there is direct evidence of discrimination.
Response: OCR agrees that different methods of proof drawn from
civil rights case law should be used in analyzing claims of
discrimination under this section including, but not limited to, the
Arlington Heights multi-factor test and the McDonnell Douglas burden-
shifting framework. For cases where the alleged discrimination is not
based on a facially discriminatory policy, we are clarifying that the
phrase ``legitimate, nondiscriminatory reason'' in these sections is
taken from, but should not be construed to limit, the method of proof
to the McDonnell Douglas burden-shifting framework. As we noted in the
Proposed Rule, Arlington Heights provides a method of proof that uses a
number of different types of evidence--e.g., direct, circumstantial,
statistical, and anecdotal--that, taken collectively, can demonstrate
that the covered entity acted because of a protected basis; the
McDonnell Douglas burden-shifting framework is an inferential method of
proof most commonly applied in cases alleging discrimination in
individual instances where a plaintiff alleges that a defendant treated
similarly situated individuals differently because of a protected
basis. 87 FR 47865. Under the Arlington Heights framework, McDonnell
Douglas evidence identifying similarly situated comparators can also be
considered but is not required.\171\
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\171\ Pac. Shores Props., LLC v. Newport Beach, 730 F.3d 1142,
1158-59 (9th Cir. 2013) (noting that a plaintiff need not rely on
the McDonnell-Douglas approach to intentional discrimination but may
instead produce other circumstantial evidence of intentional
discrimination using Arlington Heights, as McDonnell Douglas ``is
not a straightjacket requiring the plaintiff to demonstrate that
such similarly situated entities exist'').
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Comment: Many commenters supported the rule's clarification that
while providers may exercise clinical judgment when determining if a
particular service is appropriate for an individual patient, they may
not refuse gender-affirming care based on a belief that such care is
never clinically appropriate. A great number of individuals and
organizations provided comment on the types of rationales that might
constitute a legitimate, nondiscriminatory basis for a provider
declining to provide gender-affirming care. Some commenters opined that
it should not be considered discriminatory to deny care when a provider
categorically objects to gender-affirming care. Other commenters
appreciated the clarification that a provider's personal belief that
gender-affirming care is never appropriate is not a legitimate,
nondiscriminatory basis for denying such care. The majority of
commenters opined that the rule provides adequate protection for
providers exercising nondiscriminatory clinical judgment about the
appropriateness of particular care for a specific patient, though some
commenters disagreed.
Response: OCR appreciates commenters' views on proposed Sec.
92.206(c). In light of comments received, we are modifying the language
in this provision to provide additional specificity regarding how OCR
will evaluate a covered entity's proffered legitimate,
nondiscriminatory reason for denying care. We also add a reference to
Sec. 92.302 to make clear that this provision does not limit a
recipient's ability to seek assurance of an exemption based on
religious freedom or conscience laws. Also, we note that while many
commenters specifically discuss providers' personal beliefs, these
changes clarify that the rule applies to covered entities rather than
specific individuals.
To provide additional specificity, we are striking the second
sentence of Sec. 92.206(c), which previously read, ``[h]owever, 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,'' in its entirety and replacing it with: ``A covered
entity's determination must not be based on unlawful animus or bias, or
constitute a pretext for discrimination. Nothing in this section is
intended to preclude a covered entity from availing itself of
protections described in Sec. Sec. 92.3 and 92.302.'' Our reasons for
this change are as follows:
First, many commenters strongly urged OCR to consider that
providers may have a nondiscriminatory reason to not provide some
aspects of or all gender-affirming care. OCR understands that a
provider may have a legitimate nondiscriminatory reason not to provide
a health service, which the newly revised Sec. 92.206(c) makes clear.
While this section has application in the gender-affirming care
context, the revised language is also intended to make clear that it is
not limited to that context. When OCR investigates claims of
discrimination based on the denial of care, OCR will consider the
covered entity's rationale for such denial, any supporting information
the covered entity offers for its position, and any evidence of
unlawful animus, bias, or other discriminatory factors in the case.
Second, and as discussed, section 1557 prohibits discrimination on
certain prohibited bases, and does not interfere with individualized
clinical judgment about the appropriate course of care for a patient.
OCR has a general practice of deferring to a clinician's judgment about
whether a particular service is medically appropriate for an
individual, or whether the clinician has the appropriate expertise to
provide care. There is no part of section 1557 that compels clinicians
to provide a service that they do not believe is medically appropriate
for a particular patient or that they are not qualified to provide.
Since the rule does not (and cannot) set a standard of care for
gender-affirming care, the focus of any investigation will not be to
generally
[[Page 37598]]
review a covered entity's clinical judgment but rather to determine
whether the assertion of that judgment reflects unlawful animus or
bias, or is a pretext for discrimination. Similarly, outside of the
gender-affirming care context, OCR may find an invocation of clinical
appropriateness to be pretextual if, for example, the evidence
demonstrates that the covered entity asserted that pain medication was
not clinically appropriate for a patient because of the belief that
women exaggerate pain symptoms and inaccurately relay information about
their symptoms.
Third, because many commenters expressed concern about the
relationship between Sec. 92.206(c) and religious or moral beliefs
concerning gender-affirming care, we added an explicit reference in
Sec. 92.206(c) to Sec. 92.302. The new language clarifies that Sec.
92.206(c) does not preclude the process set forth in Sec. 92.302 where
a recipient's objection to gender-affirming care may be protected under
religious freedom and conscience laws.
Comment: Many commenters also cited religious or moral objections
to gender-affirming care, urging that these should be considered a
legitimate, nondiscriminatory reason to decline to provide such care.
Response: OCR understands that recipients may have religious or
conscience objections to the provision of certain types of care. Such
an objection can serve as a legitimate, nondiscriminatory reason where
it is neither pretextual nor discriminatory. If a provider typically
declines to provide a particular health service to any individual based
on a religious belief, regardless of individual's sex assigned at birth
or gender identity, the provider likely meets Sec. 92.206(c)'s
standard for a ``legitimate, nondiscriminatory reason.'' And where a
provider's religious belief causes the provider to treat individuals
differently based on sex assigned at birth or gender identity, the
provider may rely on the protections afforded by religious freedom and
conscience laws or choose to seek assurance of those protections by
making use of Sec. 92.302(b)'s assurance of religious freedom and
conscience exemption process, a feature that both the 2016 and 2020
Rules lacked. As discussed in more detail below, OCR is making several
modifications to Sec. 92.302 to strengthen and clarify this process.
Comment: Many commenters supported the inclusion of Sec. 92.206(c)
but recommended that OCR strengthen the language pertaining to
providers complying with a State or local law as a justification for
denying gender-affirming care, abortions, or other reproductive health
care to clarify that as a Federal civil rights law, the rule preempts
any such State or local law restricting access to such care. Some
commenters suggested including language in the preamble to make clear
that the majority of States' policies that restrict transgender and
nonbinary people's access to health care would be barred. Another
commenter expressed support for explicit preemption language, because
otherwise providers would be forced to attempt to comply with State and
local laws, while also trying not to run afoul of OCR's case-by-case
judgment concerning what conduct may be considered discriminatory. Some
commenters expressed concern that the rule could deem physicians'
conduct discriminatory when declining to provide services because of
State or local laws restricting those services, leaving them in an
untenable position. Other commenters criticized the rule because they
believe it preempts State laws restricting abortion and gender-
affirming care and seeks to preempt State laws on religious freedom and
conscience. A commenter expressed confusion as to how the rule would
preempt State law as opposed to simply disallowing Federal funds from
entities that do not comply.
Response: OCR understands providers' concerns that the provision's
reference regarding compliance with State or local law would place them
in a difficult position with regard to the conflicting demands of this
rule's nondiscrimination requirements and various State and local laws
restricting access to abortion or gender-affirming care. While we have
removed the language from Sec. 92.206(c) that many commenters
supported, section 1557's nondiscrimination requirements nevertheless
generally preempt conflicting State law for the reasons stated earlier
in this preamble. That said, in exercising and determining its
enforcement priorities, OCR will consider the specific factual record
of each complaint on a case-by-case basis. This may include, among
other things, consideration of whether any covered entity that is
taking discriminatory actions under the rule is doing so because it
believes in good faith it is obligated to do so by State or local law,
whether that covered entity demonstrated a willingness to refer or
provide accurate information about gender-affirming care, or is
otherwise engaging in good faith efforts to ensure patients are
receiving medically necessary care.
Comment: Several commenters expressed support for Sec. 92.206(d)'s
clarification that the enumeration of specific forms of prohibited
discrimination in Sec. 92.206(b) does not limit the general
prohibition against discrimination in Sec. 92.206(a), while
recommending that additional preamble language be added to the final
rule citing additional examples of discrimination and to provide
confirmation that OCR's investigations will not be limited by the
enumerated examples in Sec. 92.206(b).
Response: We emphasize that Sec. 92.206(b) is not an exhaustive
list of all scenarios that would constitute of sex discrimination under
the rule. We have provided additional examples of sex discrimination in
this preamble, and OCR's investigations will not be limited by the
enumerated forms of discrimination addressed in Sec. 92.206(b) or
elsewhere.
Comment: One commenter stated that OCR ignored Burwell v. Hobby
Lobby, 573 U.S. 682 (2014), in the Proposed Rule and that the Proposed
Rule is comparable to the Department's actions in that case, in which
the Court found that the government's compelling interest in protecting
women's health could be accomplished in a less restrictive manner.
Response: OCR has considered Hobby Lobby and will be mindful of it
when carrying out enforcement of the final rule. For a further
discussion of views regarding application of Federal conscience or
religious freedom laws, refer to Sec. 92.302.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing the provision as proposed in Sec. 92.206,
with modifications. We have revised Sec. 92.206(b)(1) to state: ``Deny
or limit health services, including those that have been typically or
exclusively provided to, or associated with, individuals of one sex . .
. .'' We are revising Sec. 92.206(c) to remove the sentence that
reads: ``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.'' To the end of Sec. 92.206(c)
we are adding sentences that read: ``A covered entity's determination
must not be based on unlawful animus or bias, or constitute a pretext
for discrimination. Nothing in this section is intended to preclude a
covered entity from availing itself of protections described in
Sec. Sec. 92.3 and 92.302.''
[[Page 37599]]
Nondiscrimination in Health Insurance Coverage and Other Health-Related
Coverage (Sec. 92.207)
In Sec. 92.207, OCR proposed to prohibit 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.
In Sec. 92.207(a), OCR proposed a general nondiscrimination
requirement, and Sec. 92.207(b) proposed specific examples of
prohibited actions.
In Sec. 92.207(b)(1), OCR specified 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.
In Sec. 92.207(b)(2), OCR proposed prohibiting marketing practices
or benefit designs that discriminate on the basis of race, color,
national origin, sex, age, or disability.
In Sec. 92.207(b)(3), OCR proposed 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. We invited
comment on this provision, including whether it sufficiently addresses
the challenges transgender and gender nonconforming individuals are
experiencing when seeking access to medically necessary care due to a
discordance between their sex assigned at birth and their sex as
recorded by their issuer.
In Sec. 92.207(b)(4), OCR proposed 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.\172\
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\172\ 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.''
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In Sec. 92.207(b)(5), OCR proposed 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 or
other gender-affirming care.
In Sec. 92.207(b)(6), OCR proposed 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.
OCR sought 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 institutionalization or segregation. We were interested
in feedback on the application of the integration requirement to a wide
variety of health services and were particularly interested in comments
on the application of the integration requirement 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). OCR was also interested
in feedback on the application of the integration requirement to the
Medicaid program and its statutory framework at title XIX of the Social
Security Act. Specifically, we requested input on how State Medicaid
agencies are able to achieve compliance with the integration
requirement through benefit design, such as through reimbursement,
service scope, and service authorization that do not incentivize
institutional services over community services. In addition, OCR
requested input on the amount of time needed to reach compliance with
needed benefit design modifications.
In Sec. 92.207(c), OCR stated 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.
Finally, in Sec. 92.207(d), OCR made clear that the enumeration of
specific forms of discrimination in Sec. 92.207(b) does not limit the
general applicability of the prohibition in Sec. 92.207(a).
OCR generally invited 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. We also sought
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 were 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,
OCR invited comment on all aspects of this section. In particular, we
sought comment on the anticipated impact of the proposed application to
excepted benefits and short-term, limited duration insurance (STLDI)
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 STLDI and the consumers who rely upon
those products; the prevalence of excepted benefits and STLDI offered
by covered entities and the standard industry practices under which
such plans are designed and administered; and excepted benefits and
STLDI 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.
The comments and our responses regarding Sec. 92.207 are set forth
below.
For ease of reference, OCR may simply refer to ``health insurance
issuers'' or ``issuers'' throughout the preamble, but other covered
entities may also be subject to the section under
[[Page 37600]]
discussion. In addition, for purposes of this preamble only, OCR uses
the term ``health plan'' or ``plan'' interchangeably to refer generally
to health insurance coverage and other health-related coverage that is
subject to this rule. As used in this preamble, ``health plan'' or
``plan'' may include health insurance coverage or other health-related
coverage offered in the group and individual markets, group health plan
coverage, Medicare Advantage plans, Medicare Part D plans, and Medicaid
programs that are subject to this rule. OCR does not intend ``health
plan'' or ``plan'' to be regulatory terms in this regulation or to
replace any existing or proposed term in Federal law.
OCR notes that a variety of entities may be considered covered
entities subject to Sec. 92.207, including but not limited to health
insurance issuers, group health plans, Medicare Advantage
Organizations, Medicare Part D plan sponsors, Medicaid managed care
plans, pharmacy benefit managers, third party administrators (as part
of a covered entity's operations when it meets the criteria in
paragraph (2) of the definition of ``health program or activity'' under
Sec. 92.4), and the Department.
Comment: Commenters strongly supported the inclusion of an explicit
provision related to prohibited discrimination in health insurance
coverage and other health-related coverage, noting that it will help
provide clarity for covered entities. Many commenters stated that it is
clear from the statutory text of the ACA that Congress intended for
section 1557 to apply to health insurance. Commenters stated that the
2020 Rule's rescission of similar protections created confusion, was
contrary to the intent and purpose of the ACA, and increased the burden
on States to monitor and enforce nondiscrimination laws. Commenters
noted that ensuring covered entities provide health insurance coverage
and other health-related coverage in a nondiscriminatory manner will
reduce adverse health outcomes and address some of the barriers
vulnerable communities face in accessing health insurance coverage and
other health-related coverage. Commenters from the health insurance
industry were generally supportive of reinstating the section with some
suggested modifications. This includes one commenter noting that, as an
employer, they appreciated the Proposed Rule's clarification
prohibiting categorical exclusions, noting that the 2016 Rule's similar
prohibition had allowed them to negotiate a nondiscriminatory plan to
cover their employees.
One organizational commenter opposed to the inclusion of Sec.
92.207 argued that health insurance issuers could face substantial
costs, including compliance costs and claims costs, as a result of
having to alter their coverages and business practices, which would
result in higher premiums. This commenter also argued OCR is engaging
in expansive and detailed regulation of numerous issuer business
decisions in an arbitrary and capricious manner that could result in
issuers facing heightened business risks and increased liability
exposure.
Response: OCR agrees that section 1557 applies broadly, including
to prohibit discrimination by covered entities that provide or
administer health insurance coverage and other health-related coverage.
As discussed throughout this preamble, particularly under the
discussion of the definition of ``health program or activity'' under
Sec. 92.4, the ACA is clearly intended to apply to health insurance
coverage and other health-related coverage and prohibit the
discriminatory practices therein.
OCR disagrees that Sec. 92.207 imposes expansive regulation of
health insurance issuers and their business decisions in an arbitrary
and capricious manner. The plain text of section 1557 applies to health
insurance coverage and other health-related coverage; OCR is
implementing Congressional intent to prohibit discrimination in health
insurance coverage and other health-related coverage in Sec. 92.207.
In addition to section 1557, health insurance issuers are required to
comply with myriad State and Federal laws regulating the practice of
health insurance coverage and other health-related coverage. These laws
include other Federal laws that regulate health insurance coverage and
other health-related coverage practices, including nondiscrimination
requirements.\173\ Compliance with legal requirements, such as section
1557, is a standard business practice as a health insurance issuer.
Further, health insurance issuers were subject to former Sec. 92.207's
requirements \174\ from either July 18, 2016, or January 1, 2017 (if
plan design changes were required as a result of the 2016 Rule),
through August 18, 2020, the effective date of the 2020 Rule.
---------------------------------------------------------------------------
\173\ See, e.g., 42 CFR 422.100(f)(2) and (3), 422.110 (Medicare
Advantage), 423.104(d)(2)(iii), 423.2262(a)(1)(iv) (Part D),
438.3(d) and (f) (Medicaid managed care), and 600.405(d) (Basic
Health Program); 45 CFR 147.104(e) (group and individual health
insurance markets), 156.125(a) and (b) (EHB), 156.200(e), and
156.225(b) (qualified health plans).
\174\ Issuers were subject to those requirements except for
provisions either enjoined or vacated through lawsuits. See, e.g.,
Franciscan Alliance v. Burwell, 227 F. Supp. 3d 660 (N.D. Tex.
2016).
---------------------------------------------------------------------------
Comment: Some commenters supported Sec. 92.207(b)(1), related to
coverage denials and limitations. Some commenters asked OCR to state
that cost sharing must not be used by covered entities in a
discriminatory manner. Commenters acknowledged that cost sharing can be
an effective tool, but they also expressed concern that insurance
companies and pharmacy benefit managers are increasingly employing high
cost sharing that disproportionately affects people with disabilities,
chronic conditions, and other significant health needs. Commenters
cited several studies that show patients who are uncertain about their
ability to afford their out-of-pocket care expenses delay or forgo care
or fall out of compliance with recommended follow-up steps.\175\
Commenters noted that such gaps in care can have deadly consequences
for individuals with certain conditions, such as people living with
HIV/AIDS.
---------------------------------------------------------------------------
\175\ See, e.g., Joel F. Farley, Medicaid Prescription Cost
Containment and Schizophrenia, 48 Med. Care 5, 440-47 (2010),
https://pubmed.ncbi.nlm.nih.gov/20351586/; Teresa B. Gibson & Ronald
J. Ozminkowski, The Effects of Prescription Drug Cost Sharing: A
Review of the Evidence, 11 a.m.. J. Managed Care 11, 730-40 (2005),
https://pubmed.ncbi.nlm.nih.gov/16268755/; Daniel M. Hartung et al.,
Impact of a Medicaid Copayment Policy on Prescription Drug and
Health Services Utilization in a Fee-for-Service Medicaid
Population, 46 Med. Care 6, 565-72 (2008), https://pubmed.ncbi.nlm.nih.gov/18520310/; Nantana Kaisaeng et al., Out-of-
Pocket Costs and Oral Cancer Medication Discontinuation in the
Elderly, 20 J. Managed Care Pharmacy 7, 669-75 (2014), https://pubmed.ncbi.nlm.nih.gov/24967520/; Deliana Kostova & Jared Fox,
Chronic Health Outcomes and Prescription Drug Copayments in
Medicaid, 55 Med. Care 5, 520-27 (2017), https://pubmed.ncbi.nlm.nih.gov/28234755/; Sujha Subramanian, Impact of
Medicaid Copayments on Patients With Cancer, 49 Med. Care 9, 842-47
(2011), https://pubmed.ncbi.nlm.nih.gov/21577164/; Samantha Artiga
et al., The Effects of Premium and Cost-Sharing on Low-Income
Populations: Updated Review of Research Findings, Kaiser Family
Found., pp.1-5 (2017), https://www.kff.org/medicaid/issue-brief/the-effects-of-premiums-and-cost-sharing-on-low-income-populations-updated-review-of-research-findings/; David B. Ridley & Kirsten J.
Axelsen, Impact of Medicaid Preferred Drug Lists on Therapeutic
Adherence, 24 Pharmacoeconomics Suppl. 3, 65-78 (2006), http://www.ncbi.nlm.nih.gov/pubmed/17266389.
---------------------------------------------------------------------------
Commenters also provided examples of concerns related to cost
sharing and patient financial assistance. A few commenters raised
concerns about treatment of patient financial assistance, accumulator
adjustment programs, copay maximizers, and alternative funding
programs. Other commenters raised concerns about issuers designating
drugs as ``non-essential-health-benefits'' to avoid certain
[[Page 37601]]
essential health benefits (EHB) requirements.\176\
---------------------------------------------------------------------------
\176\ See section 1302 of the ACA, codified at 42 U.S.C. 18022.
---------------------------------------------------------------------------
One organizational commenter expressed concerns about Sec.
92.207(b)(1) and argued that this provision would impose new
nondiscrimination tests on issuer business decisions that result in the
denial or limitation of payment for a claim, on variations in cost
sharing under the terms of a health plan, or on the imposition of other
limitations or restrictions on coverage. The commenter argued this
would result in expansive and detailed regulation of numerous issuer
business decisions in an arbitrary and capricious manner.
Response: OCR appreciates commenters' concerns regarding cost
sharing, which is explicitly addressed in Sec. 92.207(b)(1). Covered
entities are prohibited from ``impos[ing] additional cost sharing or
other limitations or restrictions on coverage, on the basis of race,
color, national origin, sex, age, or disability.'' We disagree with the
commenter's concerns that this provision arbitrarily or capriciously
imposes new nondiscrimination tests on issuer business decisions.
Covered entities subject to this rule are prohibited from engaging in
unlawful discrimination in their health programs or activities,
including in health insurance coverage or other health-related
coverage. Cost sharing is standard industry practice that is a feature
of an issuer's health insurance coverage or other health-related
coverage. Nothing in this rule dictates the business decisions an
issuer should make in establishing its coverage limitations, including
with regard to cost sharing. To the extent an issuer imposes cost
sharing in its coverage, it cannot do so in a discriminatory manner.
Comments related to violations of EHB requirements are outside the
scope of this regulation.\177\
---------------------------------------------------------------------------
\177\ See 42 U.S.C. 18022, 300gg-6(a); 45 CFR 156.100 through
165.155.
---------------------------------------------------------------------------
Comment: Commenters generally supported the prohibition on
discriminatory marketing practices in Sec. 92.207(b)(2). Commenters
discussed that covered entities might use marketing practices to
dissuade enrollment by individuals with high-cost conditions. For
example, commenters noted that plans present inaccurate or confusing
information about formularies and hide or fail to provide information
about certain drugs. Several commenters referenced a 2022 study by the
AIDS Institute that found 57.9 percent of the 299 Exchange plan
documents reviewed did not list PrEP (pre-exposure prophylaxis to
prevent HIV infection) as a free preventive service, though health
insurance issuers were required to include such coverage for all plans
offered through the Exchanges in 2022.\178\ Commenters asked OCR to
provide an example of discriminatory marketing practices in regulatory
text. They further requested that OCR coordinate the study of marketing
practices with other regulatory agencies.
---------------------------------------------------------------------------
\178\ Letter from The AIDS Institute to Dr. Ellen Montz, Deputy
Admin'r & Dir. (June 9, 2022), https://www.theaidsinstitute.org/letters/marketplace-insurance-plan-prep-compliance. In general,
under section 2713 of the PHS Act and its implementing regulations,
plans and issuers must provide coverage, without cost sharing, for
recommended preventive services for plan years (in the individual
market, policy years) that begin on or after the date that is 1 year
after the date the recommendation or guideline is issued. 26 CFR
54.9815-2713(b); 29 CFR 2590.715-2713(b); 45 CFR 147.130(b).
---------------------------------------------------------------------------
Response: OCR concurs with the importance of ensuring that an
issuer's marketing practices are not designed or implemented in a way
that discriminates against individuals with a specific disability or on
any other basis prohibited under section 1557. Inaccuracies or
omissions in plan marketing materials may impede an individual's
ability to determine what treatments and services are covered. While
certain inaccuracies or omissions in marketing materials may not be
prohibited discrimination under this section, inaccuracies or omissions
that were intended to or resulted in discouraging individuals from
enrolling in health insurance coverage and other health-related
coverage or steering individuals away from enrolling in health
insurance coverage and other health-related coverage on the basis of
disability or other prohibited basis would raise concerns of prohibited
discrimination. The determination of whether a particular marketing
practice is prohibited under this section requires a case-by-case
analysis dependent on the facts of the challenged marketing practice.
Accordingly, OCR declines to specify particular examples in the
regulation, though we included an example in the Proposed Rule, stating
that covered entities that avoid advertising in areas populated by a
majority of people of color to reduce the enrollment of people of color
in their health insurance coverage could violate Sec. 92.207. 87 FR
47869-70. We note that covered entities may be subject to other
Departmental and Federal regulations governing marketing
practices.\179\ While OCR declines to coordinate a study of marketing
practices, we continue to coordinate with other regulatory agencies on
health insurance-related matters.
---------------------------------------------------------------------------
\179\ See, e.g., 45 CFR 147.104(e) (health insurance issuers
offering coverage in the individual and group markets) and
156.225(b) (qualified health plans); 42 CFR 423.2263 (Medicare Part
D marketing requirements).
---------------------------------------------------------------------------
We note that individuals with LEP or disabilities may face
challenges in accessing a covered entity's marketing materials. This
final rule addresses such concerns in multiple ways, including by
requiring covered entities to provide a Notice of Nondiscrimination
under Sec. 92.10; a Notice of Availability under Sec. 92.11
(including in member handbooks at Sec. 92.11(c)(5)(x)); taking
reasonable steps to provide meaningful access to individuals with LEP
under Sec. 92.201; and taking appropriate steps to ensure effective
communication for individuals with disabilities under Sec. 92.202.
Comment: Numerous commenters supported the prohibition on
discriminatory health plan benefit designs in Sec. 92.207(b)(2).
Commenters stated that covered entities employ many features of benefit
design and delivery to deny coverage or discourage people with
significant or high-cost health needs from enrolling in their plans.
These include exclusions, cost sharing, formularies, visit limits,
provider networks, service areas, benefit substitutions, prior
authorization, and other utilization management that the commenters
allege are arbitrary and not clinically based or appropriate.
Some commenters requested that OCR define the term ``benefit
design'' or include specific examples of benefit design features in the
regulatory text of Sec. 92.207(b)(2). While some commenters expressed
concern that failing to define benefit design in the regulation would
result in a lack of clarity as to what the rule prohibits, other
commenters supported OCR's proposed approach to avoid defining the term
in a prescriptive manner.
One organizational commenter opposed Sec. 92.207(b)(2) as imposing
nondiscrimination tests on insurance benefit design, which the
commenter argued would result in expansive and detailed regulation of a
number of issuer business decisions in an arbitrary and capricious
manner.
Response: Benefit design features may result in a discriminatory
denial of access to medically necessary care, particularly for
individuals with disabilities who have significant health needs. To
address this concern, covered entities are explicitly prohibited from
having or implementing benefit designs
[[Page 37602]]
that discriminate on any protected basis as set forth under Sec.
92.207(b)(2).
We decline to define ``benefit design'' or specify types of benefit
design features in the regulatory text. Section 92.207(b)(2)
sufficiently notifies covered entities that discriminatory benefit
designs are prohibited under this rule. In addition, we seek to avoid
being overly prescriptive or unintentionally inconsistent with other
Departmental regulations that may define benefit design.\180\ While OCR
declines to provide examples of specific benefit design features in the
regulatory text, for purposes of applying section 1557 and this final
rule, 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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\180\ 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 offering
coverage in the individual and group markets), 156.200(b)(3),
156.225(b) (qualified health plans), 156.110(d), and
156.111(b)(2)(v) (EHB benchmark plans); 42 CFR 422.100(f)(3)
(Medicare Advantage), 423.2263 (Medicare Part D marketing
requirements), 423.882, 423.894(d) (Medicare retiree prescription
drug plans), 440.347(e) (Medicaid benchmark plans), and 600.405(d)
(Basic Health Program); 29 CFR 2510.3-40(c)(1)(iv)(A) (multiple
employer welfare arrangements under ERISA).
---------------------------------------------------------------------------
OCR disagrees with the organizational commenter's concern that this
provision arbitrarily or capriciously imposes new nondiscrimination
tests on issuer business decisions. This section does not dictate what
business decisions an issuer must make in establishing its benefit
design and does not specify any particular design feature must be
included. OCR acknowledges that issuers have discretion in designing
their plans; however, they must do so in a nondiscriminatory manner as
discussed throughout this section.
Comment: Commenters requested that OCR provide a non-exhaustive
list of presumptively discriminatory benefit design examples. Some
commenters also suggested that OCR incorporate the presumptively
discriminatory benefit design examples provided in CMS' EHB regulations
\181\ or otherwise rely on other nondiscrimination provisions in CMS
regulations implementing the ACA. Commenters stated that allowing plan
discretion on every benefit other than gender dysphoria undercuts the
regulation. Many commenters stated that OCR should recognize that most
benefit design elements are inherently discriminatory as they apply
disproportionately to individuals with disabilities and chronic
conditions. Commenters expressed concerns that without presumptively
discriminatory benefit design examples, issuers will adopt designs that
exclude or make lifesaving treatments unaffordable for individuals in
protected categories. Commenters noted that such designs include cost-
sharing requirements, restrictive medical necessity standards, narrow
networks, drug formularies, adverse tiering, benefit substitution,
utilization managements, exclusions, visit limits, quantity limits,
waiting periods, service areas, and coercive wellness programs.
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\181\ See Patient Protection and Affordable Care Act; HHS Notice
of Benefit & Payment Parameters for 2023, 87 FR 27208, 27301-02 (May
6, 2022).
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Response: OCR declines to provide specific examples of
presumptively discriminatory benefit designs in the rule due to the
fact-intensive analysis needed to determine whether a particular
benefit design feature is discriminatory under this section. We also
decline to give examples of presumptively discriminatory benefit
designs similar to those in EHB regulations applicable to non-
grandfathered health insurance coverage in the individual and small
group markets that CMS finalized in the preamble of its Notice of
Benefit and Payment Parameters for 2023 final rule.\182\ Essential
health benefits are governed by CMS regulations and not by this final
rule. While many of the practices cited by CMS would raise concerns of
prohibited discrimination under this rule, OCR's determinations that a
particular benefit design is discriminatory will be a fact-specific
inquiry that OCR will conduct on a case-by-case basis. OCR's process
for analyzing claims of discrimination in benefit design is discussed
in more detail under the Benefit Design Analysis discussion later in
this section. OCR will consider issuing guidance on discriminatory
practices prohibited under this section in future guidance.
---------------------------------------------------------------------------
\182\ Patient Protection and Affordable Care Act; HHS Notice of
Benefit & Payment Parameters for 2023, 87 FR 27208, 27301-05 (May 6,
2022) (providing the following examples of presumptively
discriminatory benefit designs under CMS' EHB nondiscrimination
regulations applicable to non-grandfathered health insurance
coverage in the individual and small group markets: (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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OCR disagrees that the prohibition against categorical exclusions
or limitations of coverage for all health services related to gender
transition or other gender-affirming care under Sec. 92.207(b)(4)
undercuts the regulation. Such explicit, categorical exclusions or
limitations impermissibly single out an entire category of services
based on an individual's transgender status and are presumptively
discriminatory on the basis of sex as prohibited under this section. As
discussed in detail under Sec. 92.206, this rule includes specific
provisions related to gender-affirming care given the widespread
discriminatory denial of care for such services and its direct
connection to an individual's transgender status.\183\ As discussed in
more detail below, covered entities may raise a defense under Sec.
92.207(c) where they contend that they have a legitimate,
nondiscriminatory basis for a coverage limitation that may otherwise
appear to constitute discrimination. Recipients may also rely upon
Sec. Sec. 92.3 and 92.302(a) or request an assurance of exemption
under Sec. 92.302(b) based on their view that religious freedom or
conscience protections apply.
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\183\ See, e.g., Bos. All. of Gay, Lesbian, Bisexual &
Transgender Youth v. U.S. Dep't of Health & Hum. Servs., 557 F.
Supp. 224, 239 (D. Mass. 2021) (``[p]laintiffs have shown a
substantial risk that insurers will deny reimbursement for treatment
they previously covered based on the elimination of the prohibition
on categorical coverage exclusions. Out2Enroll's analysis indicates
that ``the number of insurers using transgender-specific exclusions
. . . more than doubled'' after HHS promulgated the 2020 Rule.'').
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We also decline to incorporate examples of presumptively
discriminatory benefit designs similar to those in EHB regulations
applicable to non-grandfathered health insurance coverage \184\ in the
individual and small group markets that CMS finalized in the preamble
of its Notice of Benefit and Payment Parameters for 2023 final rule.
Essential health benefits are governed by CMS regulations and are not
addressed by this final rule. While many of the practices cited by CMS
would raise concerns of prohibited
[[Page 37603]]
discrimination under this rule, OCR's determinations that a particular
benefit design is discriminatory will be a fact-specific inquiry that
OCR will conduct on a case-by-case basis. OCR's process for analyzing
claims of discrimination in benefit design is discussed in more detail
under the Benefit Design Analysis discussion later in this section. OCR
will consider issuing guidance on discriminatory practices prohibited
under this section in future guidance.
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\184\ In general, health coverage is considered grandfathered if
it was in existence and has continuously provided coverage for
someone (not necessarily the same person, but at all times at least
one person) since March 23, 2010, provided the plan (or its sponsor)
or the issuer has not taken certain actions resulting in the plan
relinquishing grandfathered status, as more fully described at 26
CFR 54.9815-1251, 29 CFR 2590.715-1251, and 45 CFR 147.140.
---------------------------------------------------------------------------
Comment: Commenters asked OCR to include examples of discriminatory
benefit design specifically related to prescription drug formularies.
These commenters provided examples of practices they considered to be
discriminatory, such as issuers placing most or all drugs used in the
treatment of certain conditions into the highest cost sharing tier;
excluding single tablet regimens even when they are the standard of
care for a condition; requiring the use of specialty pharmacy programs
that require mail delivery even when that adds unnecessary and
burdensome administrative barriers and delays to obtaining drugs; and
using quantity limits for an entire class of medications without
scientific or clinical explanation. Commenters expressed concerns that
discriminatory prescription drug formularies discourage enrollment
among certain populations, including individuals with HIV, mental
health needs, or other chronic conditions. Commenters noted that
enrollees who need high-cost medications often must choose between
plans that will provide adequate coverage of their medication or plans
that cover their preferred providers. A commenter cited a study that
showed that Black and Hispanic/Latino people are more likely to abandon
medications at the pharmacy because of high cost.\185\ Finally, some
commenters recommended that OCR develop specific mechanisms to monitor
prescription drug formulary practices and coverage of physician-
administered ``medical benefit'' drugs to ensure that formularies are
not used to discriminate against patients with specific disabilities.
---------------------------------------------------------------------------
\185\ PhRMA, Patient Experience Survey: Barriers to Health Care
Access in the Patient Experience, pp. 10-11 (2021), https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PES-Report_100621_Final.pdf (stating that utilization management
disproportionately impacts people of color (Black Americans (56
percent) and Hispanic Americans (60 percent) versus white Americans
(36 percent)) and that barriers imposed by utilization management
can contribute to poor medication adherence or prescription
abandonment).
---------------------------------------------------------------------------
Response: Benefit design practices related to prescription drugs
have an enormous impact on individuals' access to medically necessary
medication. Coverage of prescription drugs could pose concerns of
prohibited discrimination and OCR would investigate such practices
under the rule on a case-by-case basis. OCR declines to state that
specific practices are per se discriminatory under the rule because
each investigation is a fact-specific inquiry, based on
nondiscrimination principles and relevant case law,\186\ including
consideration of the covered entity's reason for the design feature in
question.
---------------------------------------------------------------------------
\186\ See, e.g., Doe v. CVS Pharmacy, Inc., 982 F.3d 1204, 1212
(9th Cir. 2020); Doe v. BlueCross BlueShield of Tenn., 926 F.3d 235,
241 (6th Cir. 2019).
---------------------------------------------------------------------------
As discussed in the Proposed Rule, several benefit design practices
related to drug formularies could be discriminatory under this section,
including 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, and benefit designs that place utilization management
controls on most or all services that treat a particular disease or
condition but not others. 87 FR 47874. OCR notes that coverage of
physician-administered ``medical benefit'' drugs would be considered
part of a plan's benefit design and therefore subject to this rule.
While we identify some prescription drug practices above that may
raise concerns under section 1557, this rule does not prohibit covered
entities from engaging in nondiscriminatory practices related to
prescription drug benefit design. For example, covered entities may
utilize preferred drug lists, such as preferred drug lists under the
Medicaid program under title XIX of the Social Security Act, as long as
the coverage criteria does not constitute prohibited discrimination. In
addition, as discussed in more detail below, covered entities are not
prohibited from applying nondiscriminatory utilization management
techniques in their drug formularies.
Comment: Many commenters expressed concerns about benefit designs
that impose coverage limitations or exclusions related to health
services that could result in discrimination on the basis of
disability. For example, some commenters argued that plans should not
be permitted to have blanket exclusions for services related to ASD or
applied behavioral analysis (ABA) therapy, a therapeutic intervention
sometimes recommended for autistic children.
Several commenters raised concerns about how frequently insurance
benefit design practices inappropriately limit coverage of durable
medical equipment. Commenters noted that issuers place unique annual
coverage caps on items such as wheelchairs, ventilators, and hearing
aids. A commenter noted an example of an individual with hearing loss
that requires treatment other than cochlear implants being denied
coverage of hearing aids and outpatient visits to an audiologist due to
their issuer's blanket exclusion of programs or treatments for hearing
loss other than cochlear implants. Another commenter noted that issuers
limit coverage of multiple-use speech-generating devices, which are
most useful and effective for autistic individuals, even when those
devices are less expensive than single-use speech generating devices.
Other commenters expressed concerns that covered entities include
clinically inappropriate limits on the coverage of habilitative and
rehabilitative services and devices. Commenters noted that such
limitations, including on the number of covered visits, discriminate
against people with more significant disabilities who need extensive
habilitation or rehabilitation in order to gain, regain, or maintain
functioning. Commenters requested that OCR clarify that blanket
limitations or exclusions of habilitative services for individuals with
specific disabilities are prohibited discrimination under section 1557
when those same services are allowed for rehabilitation of nondisabled
persons. Commenters noted that people with developmental disabilities
are routinely denied coverage for habilitative services needed to gain
skills or improve functioning while an identical service is covered for
individuals who require it for rehabilitative care to restore
functioning. For example, a commenter noted that coverage of ``speech
therapy to restore speech'' results in excluding all children with
developmental delays who need the therapy to attain speech. Commenters
noted that habilitative services are important for children who are
delayed in walking or talking or need to learn other muscular skills
for the first time and for individuals with disabilities to be able to
live as independently as possible.
Response: OCR appreciates the variety of concerns raised by
commenters. A coverage limitation or exclusion that is based on a
specific disability or condition (or other basis prohibited by section
1557, such as age, discussed below), would be investigated as
[[Page 37604]]
potentially discriminatory under this rule. Blanket exclusions of all
treatments related to a particular condition, such as ASD or hearing
loss, would raise significant concerns of prohibited discrimination on
the basis of disability such that OCR would expect the covered entity
to provide a legitimate, nondiscriminatory reason for the exclusion.
Non-categorical exclusions or limitations for certain treatments
related to a specific disability or condition may also raise concerns
under the rule. This rule, however, does not require covered entities
to cover all services related to a specific disability or condition.
Application of standard disability discrimination principles requires a
specific analysis of each claimed exclusion. We therefore decline to
expressly state that a particular coverage exclusion or limitation is
per se discriminatory on the basis of disability under this rule.
Determinations of whether a particular coverage exclusion or limitation
is discriminatory will be evaluated on a case-by-case basis, in
accordance with longstanding civil rights principles and relevant case
law, as discussed throughout this section. When investigating a
potentially discriminatory exclusion or limitation, OCR will consider
whether the covered entity has a legitimate, nondiscriminatory reason
for the challenged design feature. If OCR determines that the covered
entity's reason is a legitimate, nondiscriminatory reason that is not a
pretext for discrimination, OCR will conclude that the challenged
exclusion or limitation is not prohibited under the rule.
Regarding durable medical treatment, the commenters' example of
exclusions of coverage for programs or treatments for hearing loss
other than cochlear implants has been the subject of at least two court
cases where the courts have held that such exclusions do not state a
claim for proxy disability discrimination under section 1557.\187\
---------------------------------------------------------------------------
\187\ Schmitt v. Kaiser Found. Health Plan of Wash., 965 F.3d
945, 960 (9th Cir. 2020); E.S. v. Regence BlueShield, No. 2:17-cv-
01609-RAJ, 2022 WL 279028, at *8-9 (W.D. Wash., Jan. 31, 2022).
---------------------------------------------------------------------------
We also note that health insurance issuers may be subject to other
Departmental authorities that are relevant to issues raised by
commenters.\188\ For example, to the extent durable medical equipment
is an EHB, like hearing aids are in some states, covered entities may
also be subject to CMS' EHB nondiscrimination regulations at 45 CFR
156.125 applicable to non-grandfathered health insurance coverage in
the individual and small group markets.\189\ Further, CMS' EHB
regulations require coverage of habilitative services and devices, and
specify that plans may not impose limits on coverage of habilitative
services and devices that are less favorable than limits imposed on
coverage of rehabilitative services and devices.\190\
---------------------------------------------------------------------------
\188\ See, e.g., Paul Wellstone and Pete Domenici Mental Health
Parity and Addiction Equity Act of 2008 (MHPAEA).
\189\ See Patient Protection and Affordable Care Act; HHS Notice
of Benefit and Payment Parameters for 2023, 87 FR 27208, 27301-02
(May 6, 2022) (concluding that age limitations on hearing aid
coverage are presumptively discriminatory under 45 CFR 156.125 when
applied to EHB and there is no clinical basis for the age
distinction). We note these regulations are enforced by CMS and are
distinct from section 1557 and other civil rights laws enforced by
OCR.
\190\ 45 CFR 156.110(a)(7) and 156.115(a)(5)(ii).
---------------------------------------------------------------------------
Comment: Many commenters raised concerns related to mental health
services. Commenters asked OCR to require both public and private
payers to remedy the current inadequacies and inequities in mental
health service reimbursement rates and policies, explaining that
reimbursement rates have been historically lower for mental health
services than physical health services. Commenters also identified a
range of specific mental health benefit design inequities, including
the need for intermediate-care facility coverage for high-use patients
with non-urgent care needs to mobile crisis response that is on par to
that of physical emergency response. Commenters also requested that the
rule align with the mental health parity protections in the Paul
Wellstone and Pete Domenici Mental Health Parity and Addiction Equity
Act of 2008 (MHPAEA).
Response: OCR acknowledges commenters' concerns regarding coverage
for mental health services. Mental health services may be needed by
people who may or may not be individuals with disabilities under this
rule. OCR will examine complaints alleging less favorable treatment for
mental health coverage as compared to physical health coverage on a
case-by-case basis to determine if the coverage discriminates against
people with disabilities. Reimbursement rates and policies are subject
to Sec. 92.207 as part of a plan's benefit design, and thus must be
provided in a nondiscriminatory manner. We also discuss reimbursement
rates in the context of the integration provision under Sec.
92.207(b)(6).
We decline to incorporate or align this rule with MHPAEA, as
section 1557 is a distinct Federal civil rights law. We note that
coverage limitations found to violate section 1557 may also be
prohibited under MHPAEA.\191\
---------------------------------------------------------------------------
\191\ The Paul Wellstone and Pete Domenici Mental Health Parity
and Addiction Equity Act of 2008 (MHPAEA), Public Law 110-343; 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 and 45 CFR 147.160, 29 CFR 2590.712, and 26 CFR
54.9812-1, respectively; The Departments of the Treasury, Labor, and
HHS also published proposed rules on August 3, 2023 (88 FR 51552),
to amend existing regulations and establish new regulations for the
nonquantitative treatment limitation comparative analyses required
under MHPAEA, as amended by the Consolidated Appropriations Act,
2021. The proposed rules would amend the existing rules to prevent
group health plans and health insurance issuers offering group or
individual health insurance coverage that provides both medical and
surgical benefits and mental health or substance use disorder
benefits from using nonquantitative treatment limits to place
greater limits on access to mental health and substance use disorder
benefits as compared to medical/surgical benefits; see also U.S.
Dep't of Labor, U.S. Dep't of Health & Hum. 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.
---------------------------------------------------------------------------
Comment: Commenters expressed concerns about issuers discriminating
against enrollees based on age through certain benefit designs.
Commenters provided examples of practices they believed to be
discriminatory, such as issuers requiring an ASD diagnosis by a certain
age to access coverage for ASD-related health care; not covering
hearing aids for adults when otherwise covered for children; and
imposing limitations on wheelchair and mobility device replacement for
children that fail to align with how quickly children outgrow such
devices. One commenter asked that OCR require issuers to attest that
their pediatric benefit packages are comprehensive and age-appropriate
by demonstrating that physical and mental health benefits do not have
age, visit, or coverage limits that are not based on medical necessity
or that are based on adult metrics. Commenters noted that plans that
limit coverage to specific conditions or a child's capacity to attain a
certain functional status will unfairly prevent many children with
special health care needs from accessing critically important services.
Response: Section 1557 prohibits discrimination on the basis of
age, consistent with the Age Act and its implementing regulations. The
Age Act allows age distinctions under certain circumstances, including
distinctions
[[Page 37605]]
that reasonably take into account age as a factor necessary to the
normal operation or the achievement of any statutory objective \192\ of
a program or activity; are based on age-related factors that bear a
direct and substantial relationship to the normal operation of the
program or activity or to the achievement of a statutory objective;
provide special benefits to the elderly or children; or are contained
in a rule or regulation issued by the Department.\193\ As a result, not
all age-related distinctions in State or Federal law, including
Department regulations, are prohibited by section 1557.\194\ As noted
above, these permissible age distinctions form part of the ``ground''
of discrimination prohibited under the Age Act, because they identify
distinctions that either are not forbidden age discrimination, 42
U.S.C. 6103(b)(1)(A) (``reasonably takes into account age as a factor
necessary to the normal operation or the achievement of any statutory
objective of such program or activity''), or are not age discrimination
at all, id. section 6103(b)(1)(B) (``based upon reasonable factors
other than age'').
---------------------------------------------------------------------------
\192\ 45 CFR 91.12(b) (Defining ``Statutory objective'' to mean
``any purpose of a program or activity expressly stated in any
Federal statute, State statute, or local statute or ordinance
adopted by an elected, general purpose legislative body.'').
\193\ See 42 U.S.C. 6103(b); 45 CFR 91.12 through 91.14 and
91.17.
\194\ See, e.g., 42 U.S.C. 300gg; 45 CFR 147.102 (permitting
premium rates charged by a health insurance issuer for health
coverage offered in the individual or small group market to vary
with respect to the particular plan of coverage by age, among other
factors).
---------------------------------------------------------------------------
When investigating a benefit design with an age distinction, OCR
will first determine whether the distinction is permitted under the Age
Act (and therefore section 1557). If it is not, OCR will then
investigate the age distinction to determine whether it violates
section 1557. As with other benefit design investigations, OCR's
analysis will involve a fact-specific inquiry and will consider a
covered entity's reason for the age distinction in its benefit design.
The covered entity's justification must be a legitimate,
nondiscriminatory reason, as discussed under Sec. 92.207(c). For
example, if an issuer is not able to provide a legitimate,
nondiscriminatory reason to substantiate an age distinction in ASD
coverage, such an age distinction would likely violate section 1557. We
reiterate that this rule does not require a covered entity to provide
coverage for all health services related to a particular disability or
condition; rather, it requires covered entities to design their plan
benefits in a nondiscriminatory manner. We note that covered entities
may also be subject to relevant CMS EHB nondiscrimination regulations
regarding presumptively discriminatory age distinctions.\195\
---------------------------------------------------------------------------
\195\ See, e.g., Patient Protection and Affordable Care Act; HHS
Notice of Benefit & Payment Parameters for 2023, 87 FR 27208, 27301-
02 (May 6, 2022) (providing examples of presumptively discriminatory
benefit designs under CMS' EHB nondiscrimination regulations
applicable to non-grandfathered health insurance coverage in the
individual and small group markets that include limitations on
hearing aid coverage based on age, autism spectrum disorder coverage
limitations based on age, and age limits for infertility treatment
coverage when treatment is clinically effective for the age group).
These regulations are enforced by CMS and are distinct from section
1557 and other civil rights laws enforced by OCR.
---------------------------------------------------------------------------
OCR does not agree that it is necessary to require a separate
attestation related to pediatric benefit packages. As recipients of
Federal financial assistance, issuers are required to submit an
Assurance of Compliance with section 1557 under Sec. 92.5, which
attests that they will not discriminate on the basis of age, among
other prohibited bases.
Comment: A commenter requested that OCR clarify the obligation of
issuers and plan administrators to ensure that their staff, as well as
the staff of any subsidiary entities with which they do business,
receive explicit training on the relationship between benefit design
choices and practices and activities that can amount to discrimination
based on race, color, national origin, sex, age or disability.
Response: Covered entities are responsible for ensuring their
staff, subrecipients, and subcontractors are compliant with section
1557. Section 92.9 requires covered entities to provide training to
relevant employees on their section 1557 Policies and Procedures, and
while we note that it is in a covered entity's best interest to ensure
that relevant staff are adequately trained, we decline to specify
additional training requirements at this time.
Comment: Commenters requested that the final rule expressly state
that section 1557 prohibits proxy discrimination in benefit design,
either in the preamble or regulation. Commenters expressed concern that
absent express incorporation of proxy principles, covered actors may
attempt to evade section 1557's nondiscrimination provisions. A
commenter requested that the final rule incorporate established
discrimination principles and noted that issuers continue to justify
discriminatory plan designs by taking the position that health plans
that target a particular medical service rather than a disability are
neutral or uniform with respect to all enrollees. As an example, the
commenter noted that plans restricting coverage of dialysis justify it
as not being discriminatory against enrollees with end-stage renal
disease. The commenter requested that the final rule declare that
discriminatory plan designs that limit dialysis treatment are a form of
prohibited disability discrimination under section 1557 due to the fact
that dialysis services are a near perfect proxy for end-stage renal
disease, according to the commenter.
Response: Proxy discrimination occurs when a policy or practice
treats individuals differently on the basis of seemingly neutral
criteria that are so closely associated with the disfavored group that
discrimination on the basis of such criteria is, constructively, facial
discrimination against the disfavored group.\196\ Proxy discrimination
is one of many basic civil rights theories available to OCR when
investigating complaints under section 1557 and which courts have
applied in cases alleging discrimination under section 1557.\197\ Due
to the fact-intensive nature of the analysis necessary, including
determinations of whether a particular benefit design is
discriminatory,\198\ we decline to expressly include this theory of
discrimination in the rule text. As we have noted above, all claims
under this section will be evaluated on a case-by-case basis.
---------------------------------------------------------------------------
\196\ Schmitt v. Kaiser Found. Health Plan of Wash., 965 F.3d
945, 958 (9th Cir. 2020) (citing Davis v. Guam, 932 F.3rd 822, 837
(9th Cir. 2019)).
\197\ See, e.g., Schmitt v. Kaiser Found. Health Plan of Wash.
No. 2:17-cv-01611-RSL, 2018 WL 4385858 (W.D. Wash. Sept. 14, 2018),
aff'd in part, rev'd in part and remanded, 965 F.3d 945 (9th Cir.
2020); E.S. v. Regence BlueShield, No. 2:17-CV-01609-RAJ, 2022 WL
279028, at *1 (W.D. Wash. Jan. 31, 2022).
\198\ See, e.g., Schmitt v. Kaiser Found. Health Plan of Wash.,
No. 2:17-cv-01611-RSL, 2018 WL 4385858 (W.D. Wash. Sept. 14, 2018),
aff'd in part, rev'd in part and remanded, 965 F.3d 945 (9th Cir.
2020); E.S. v. Regence BlueShield, No. 2:17-CV-01609-RAJ, 2022 WL
279028, at *1 (W.D. Wash. Jan. 31, 2022).
---------------------------------------------------------------------------
Comment: Some commenters noted that health insurance coverage and
other health-related coverage may employ coverage limitations that are
facially neutral and apply to all enrollees but have a disparate impact
on a basis protected under section 1557. Specifically, commenters
observed that these limitations and exclusions can have a particular
discriminatory effect on individuals with disabilities who have chronic
conditions and significant health needs.
Response: OCR utilizes all applicable causes of action when
investigating potential discrimination under section 1557 consistent
with relevant case law. For further discussion related to OCR's
enforcement procedures, see Sec. 92.301.
[[Page 37606]]
Comment: Commenters requested that the final rule make clear the
language in Sec. 92.207(b), which addresses sex-related health
services, includes the full spectrum of reproductive health services
and treatments and medications for people with disabilities that may
prevent, complicate, or end fertility or pregnancies.
Response: OCR appreciates the unique challenges faced by people
with disabilities seeking reproductive health care. Section 1557
prohibits discrimination on prohibited bases regardless of the type of
care an individual is seeking or receive. Therefore, we do not believe
it is necessary to provide specific provisions related to each form of
care an individual may seek.
Comment: Commenters requested that the final rule expressly state
that infertility diagnoses, treatment, and services, including assisted
reproductive technology, if offered, must be covered without regard to
sexual orientation, gender identity, sex characteristics (including
intersex traits), or any other protected basis. Commenters raised
several examples of benefit design or coverage related to assisted
reproductive technology that they stated should be prohibited as
discriminatory against individuals based on their relationship status
and sexual orientation. As examples, commenters cited requiring
enrollees to use their spouse's sperm to fertilize their eggs for in
vitro fertilization and requiring that single enrollees or those in
non-heterosexual relationships pay out of pocket for a predetermined
number of failed intrauterine insemination cycles before providing
coverage when heterosexual couples do not have to meet the same
standard. Commenters stated that issuers justify these types of benefit
design features on outdated definitions of infertility. A commenter
argued that in vitro fertilization coverage should include screening
for genetic abnormalities that are unique to enrollees' lineage as a
matter of reproductive justice and religious freedom.
Response: OCR agrees that to the extent plans cover infertility
diagnosis, treatment, and services, including assisted reproductive
technology, they must do so on a nondiscriminatory basis, including for
same-sex couples. Due to the fact-intensive nature of the analysis
necessary, determinations of whether a particular benefit design is
discriminatory under this section will be evaluated on a case-by-case
basis.
Comment: Commenters recommended that OCR add a new paragraph to
Sec. 92.207(b) affirming that denying or limiting coverage of, or
coverage of a claim for, health services because they may prevent,
cause complications to, or end fertility or pregnancies is prohibited.
Commenters asserted this language would address discrimination by a
State program that otherwise provides coverage of contraceptives but
excludes a specific contraceptive because of a medically inaccurate
assertion that the contraception causes an abortion, or a provider
network that only includes facilities that refuse to provide certain
types of contraception. Commenters emphasized that individuals are
currently being improperly denied access to medications or treatments
for care unrelated to abortion because the medicine is also used for
abortion care.
Response: Denying access to specific medication or health services
that may potentially be used for medication abortion purposes but are
prescribed for reasons unrelated to abortion care may constitute
discrimination under section 1557.\199\ OCR finds it unnecessary to add
any additional regulatory language to prohibit such discrimination on
the basis of disability and sex. As noted above, simultaneous
discrimination on multiple prohibited bases is important to account for
and is prohibited by section 1557.
---------------------------------------------------------------------------
\199\ See U.S. Dep't of Health & Hum. Servs., Guidance to the
Nation's Retail Pharmacies: Obligations Under Federal Civil Rights
Laws to Ensure Nondiscriminatory Access to Health Care at Pharmacies
(Sept. 29, 2023), https://www.hhs.gov/civil-rights/for-individuals/special-topics/reproductive-healthcare/pharmacies-guidance/index.html.
---------------------------------------------------------------------------
Comment: A commenter asked OCR to provide confirmation that while
nothing in the regulation would require a covered entity to cover
abortions, to the extent plans do cover abortions, they must do so on a
nondiscriminatory basis.
Response: As the commenter stated, nothing in this rule requires
the provision of any particular medical care, including abortion. To
the extent plans offer coverage for termination of pregnancies and
related services, they must do so on a nondiscriminatory basis.
Comment: Commenters recommended that OCR revise the regulatory text
of proposed Sec. 92.207(b)(4) and (5) to address sex discrimination
related to pregnancy or related conditions by adding discrimination
related to abortion, fertility care, and contraception. Some commenters
requested that OCR specifically add ``termination of pregnancy,
contraception, fertility care, miscarriage management, pregnancy loss,
maternity care, other reproductive and sexual health services, or any
health services'' to the prohibitions on exclusions, limitations, and
cost sharing related to gender transition or other gender-affirming
care in Sec. 92.207(b)(4) and (5).
Response: OCR declines this suggestion. Section 92.207(b)(4) and
(5) are not intended to list all types of potentially prohibited
exclusions. The general prohibition on discriminatory limitations under
Sec. 92.207(b)(1) would apply to any exclusion or limitation related
to all types of care that resulted in discrimination on the basis of
sex.
Comment: Some commenters stated that they oppose Sec. 92.207 to
the extent it violates religious freedom and conscience protections.
Other commenters stated that they opposed Sec. 92.207 because it
prevents plans from excluding coverage of all gender affirming care.
Response: Section 92.207 does not violate such protections because
providers may rely on the protections of Federal religious freedom and
conscience laws or choose to seek assurance of those protections from
OCR under this final rule. With respect to concerns about potential
conflicts between provisions of the final rule and individuals' or
organizations' conscience or religious freedom, please refer to the
preamble discussion of Sec. 92.302. Additionally, we are revising
Sec. 92.207(c) to specify that nothing in this section precludes a
covered entity from availing itself of protections described in Sec.
92.3 and Sec. 92.302. This modification is consistent with the revised
language in Sec. 92.206(c). As noted elsewhere in this preamble, and
in Sec. 92.3(c), insofar as the application of any rule requirement
would violate applicable Federal protections for religious freedom and
conscience, such application shall not be required.
Comment: Many commenters expressed strong support for the
provisions in Sec. 92.207(b)(3) through (5), citing the extensive
discrimination faced by transgender people in the health insurance
coverage and other health-related coverage context. Several legal
service providers described their experiences assisting clients facing
various types of discrimination in their health plans, even where State
law or the plan terms provided some protection for gender-affirming
care. Some commenters noted these provisions also addressed forms of
discrimination commonly faced by intersex people. Commenters noted that
the physical, mental health, and financial costs of such discrimination
could be high, with individuals forgoing necessary care, facing extreme
financial
[[Page 37607]]
burdens, and experiencing distress when denied access to necessary
medical care.
Both supporters and opponents of the Proposed Rule raised many of
the same issues discussed in Sec. 92.206(b)(4) (prohibiting
categorical coverage exclusions on gender transition or other gender-
affirming care) and (c) (discussing legitimate, nondiscriminatory
reasons for denying or limiting care) above. As with Sec. 92.206, some
commenters asked OCR to define gender-affirming care or provide more
detail about what types of care must be covered.
Response: OCR agrees that transgender and intersex people have long
faced discrimination in the health insurance coverage and other health-
related coverage context. Many of OCR's responses to the comments in
Sec. 92.206(b)(4) (prohibiting categorical coverage exclusions on
gender transition or other gender-affirming care) and (c) (discussing
legitimate, nondiscriminatory reasons for denying or limiting care)
above are applicable to the comments in this section as well. For
example, for the reasons we discussed above, we will not provide a
definition of ``gender-affirming care'' in the regulation text.
Comment: Commenters noted that even plans without categorical
exclusions will exclude certain types of gender-affirming care as
``cosmetic.'' Commenters noted that categorizing procedures as cosmetic
when needed for gender-affirming care is contrary to established
standards of care for the treatment of gender dysphoria and urged OCR
to explicitly prohibit such procedure-specific exclusions. Some
commenters further noted that plans will often consider these
procedures on a case-by-case basis when not related to gender
transition but will not do so when the care is related to gender
transition.
Many commenters recommended deleting the word ``all'' from Sec.
92.207(b)(4) to make clear that the exclusion of any gender-affirming
care from coverage is prohibited. Some commenters stated that this
change would be more consistent with Sec. 92.207(b)(5), which more
generally prohibits discriminatory limits on gender-affirming care
coverage.
Response: OCR appreciates commenters' feedback and concern about
forms of discrimination beyond broad categorical coverage exclusions.
While we understand that some gender-affirming care exclusions are
limited to the specific type of care at issue, we decline to revise the
language of Sec. 92.207(b)(4). Section 92.207(b)(5)'s general
prohibition on limitations or restrictions on coverage for gender
transition or other gender-affirming care reaches the narrower
exclusions or restrictions on gender-affirming care.
We also decline to state that any denial of gender-affirming care
will necessarily be discriminatory regardless of context or rationale.
We will instead consider claims of discrimination raising non-
categorical denials on a case-by-case basis. Where OCR receives
complaints about such exclusions or restrictions, we will investigate
on a case-by-case basis whether they constitute prohibited
discrimination under Sec. 92.207(b)(5) or any other applicable
provision of the rule. Since section 1557 only prohibits discrimination
and does not prescribe any specific standard of care, such denials will
violate the final rule only where they entail discrimination on the
basis of sex. As stated throughout this section, covered entities will
have the opportunity to provide a legitimate, nondiscriminatory reason
for such exclusions or restrictions.
Comment: Some commenters proposed striking the phrase ``if such
denial, limitation, or restriction results in discrimination on the
basis of sex'' from Sec. 92.207(b)(5), stating that the elimination
would make this provision clearer. Commenters viewed this phrase as
confusing and redundant, as they stated that limiting or restricting
coverage for services related to gender-affirming care is necessarily
discriminatory. Another commenter noted the intersectionality of
discrimination and stated that this language may be limiting.
Response: For the reasons discussed above, we disagree that any
restriction impacting gender-affirming care will necessarily constitute
prohibited discrimination. For example, if an insurance plan places
restrictions on coverage for gender-affirming surgeries that are no
more stringent than the restrictions placed on any other type of
surgical care, those restrictions will not violate the rule. As such,
we decline to make the deletion proposed by these commenters.
OCR agrees that the rule prohibits discrimination in the provision
or coverage of gender-affirming care whether it is on the basis of sex
or on the basis of race, color, national origin, age, or disability.
That said, allegations about such discrimination are best brought under
Sec. 92.207(b)(1), as Sec. 92.207(b)(5) is aimed at the types of
denials or limitations on coverage that are based on a person's gender
identity and are thus a form of sex discrimination.
Comment: Commenters noted that even plans without categorical
exclusions of gender-affirming care may adopt barriers to accessing
such care, such as more stringent pre-approval processes. The
commenters noted that these requirements could result in transgender
people ultimately not receiving necessary care or having to invest
significant time and resources to navigate the barriers. Some
commenters additionally noted the high mental health toll on
individuals facing discriminatory limitations on medically necessary
care.
Response: OCR appreciates the commenter's feedback and concern
about the forms of discrimination transgender people encounter in
seeking coverage for gender-affirming care but declines to revise Sec.
92.207(b)(3) as suggested. Section 92.207(b)(5) prohibits limitations
or restrictions on coverage for gender transition or other gender-
affirming care.
Comment: Many commenters supported the provisions limiting issuers'
ability to deny care based on a person's sex assigned at birth, gender
identity, or gender otherwise recorded, noting that transgender,
nonbinary, and intersex people can all face such discriminatory
denials. Other commenters objected to these provisions, expressing
concern that this would compel issuers to pay for care that was not
medically necessary or appropriate for a given individual.
Response: Section 92.207(c) makes clear that a nondiscriminatory
determination that care is not medically necessary based on a patient's
anatomy or medical need is permissible. For example, this final rule
would not prohibit a covered entity from denying coverage for
preventive health services for a transgender patient where such care is
not medically necessary, such as a prostate exam for a transgender man
who does not anatomically have a prostate. In contrast, the rule may
prohibit a covered entity from denying coverage for medically necessary
preventive care for a transgender patient.
Comment: One provider group urged OCR to work with the Office of
the National Coordinator for Health Information Technology (ONC) and
electronic health record vendors to ensure that there are options for
separately identifying a patient's gender identity and anatomy to
reduce the risk of improper denials.
Response: OCR appreciates the suggestion that discriminatory
denials could be reduced if the records systems used by providers,
issuers, and other covered entities provide better options
[[Page 37608]]
for recording gender identity and sex characteristics. While minimum
standards for record systems are not within the scope of the rule, we
are committed to working with ONC and other relevant stakeholders to
explore solutions to this issue.
Comment: Commenters noted that transgender people often have
difficulty getting their health coverage to update their records to
reflect their correct name and gender. Commenters noted that gender
marker mismatches in health insurance records can result in denial of
coverage for clinically appropriate care, and one commenter urged OCR
to make clear that claims processing procedures that automatically deny
coverage for care based on a perceived mismatch of sex or gender is a
form of impermissible sex discrimination.
Response: OCR appreciates commenters' concerns about coverage
denials due to a sex mismatch in claims processing procedures, which
can result in transgender patients being denied coverage for a
medically necessary and clinically appropriate services. However, we
decline to categorically state that sex mismatch denials are always
discriminatory. Instead, OCR will consider and investigate complaints
raising this issue on a case-by-case basis under Sec. 92.207(b)(3).
While we refrain from categorically stating that initial sex mismatch
or coding denials are prohibited under this rule, we caution that
denials resulting in an undue delay or denial of services, such as
repeated denials, could result in a finding of prohibited
discrimination. For more information on OCR's view of this issue,
please see the 2016 Rule preamble's discussion on computer systems with
gender coding resulting in gender mismatches at 81 FR 31436.
Comment: With respect to cases where coverage for comparable
treatments is relevant to the discrimination analysis, some commenters
urged OCR to clarify that the question of what is comparable can be
construed broadly, rather than parsing minor differences in broadly
similar types of care.
Response: OCR declines to identify a bright line of how similar
care must be to be considered comparable when such considerations are
relevant to a discrimination claim, as there are many factors that may
be relevant to this analysis, and our approach is case by case.
Comment: Commenters who addressed the integration requirement in
Sec. 92.207(b)(6) overwhelmingly supported the newly proposed
provision, which clarifies the prohibition on having or implementing
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. Several noted the particular importance of this provision
and access to community integration in light of the COVID-19 pandemic
and the higher infection risks associated with congregate settings. A
few commenters noted the role that discrimination on multiple bases may
play with regard to community integration, highlighting the
overrepresentation of people of color in institutional settings, and
the relationship between access to effective communication and
community integration. Numerous comments included examples of current
practices that may violate the integration provision.
Commenters agreed that this provision should apply to both benefit
design and implementation of a benefit design, including: coverage,
exclusions, and limitations of benefits; prescription drug formularies;
cost sharing (including copays, coinsurance, and deductibles);
utilization management practices; medical management standards
(including medical necessity standards); provider network design;
provider reimbursement; standards for provider admission to participate
in a network; benefits and service administration contracted to third
parties, such as pharmacy benefit managers; and quality measurement and
incentive systems. Many commenters requested that OCR clarify that the
convenience or potential cost-saving of administering treatments in
institutional settings are not legitimate, nondiscriminatory reasons
for not providing comparable benefits in less restrictive settings.
Commenters suggested that providing coverage to qualified
individuals with disabilities in the most integrated setting
appropriate should not be done in a way that unnecessarily increases
costs for all enrollees or compromises individual health benefits.
Response: We appreciate support for the inclusion of this
provision. OCR recognizes the importance of providing and administering
health coverage in the most integrated setting appropriate to the needs
of qualified individuals with disabilities; we also recognize that
discrimination on multiple bases heightens barriers and are committed
to addressing allegations of discrimination on all bases protected
under section 1557. As discussed in the Proposed Rule, 87 FR 47873,
this provision encompasses both the benefit design of the benefit being
offered by a covered entity as well as the indirect mechanisms that
affect the implementation of the benefit design within a covered
entity's control, such as utilization management practices, provider
reimbursement, contracting out to third-party contractors such as
pharmacy benefit managers, and quality measurement and incentive
systems. OCR is not prescriptive in the list of potential mechanisms
that could result in prohibited discrimination through implementation
of a benefit design because it is a case-by-case analysis depending on
the facts of each situation.
With respect to concerns about unnecessarily increasing costs to
comply with this provision, OCR notes that institutional care is
generally more expensive than community-based care and that increased
cost alone is not necessarily a fundamental alteration.\200\ However,
concerns related to cost can be raised through a fundamental
alterations defense.\201\
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\200\ Fisher v. Okla. Health Care Auth., 335 F.3d 1175, 1183
(10th Cir. 2003).
\201\ Id. at 1182.
---------------------------------------------------------------------------
Comment: Nearly all commenters who addressed this provision agreed
with the 2022 NPRM preamble language stating that requiring prior
authorization, step therapy, or other utilization management when
individuals access treatment in the community but not in an
institution, would constitute discrimination if the discrepancy results
in unnecessary segregation or a serious risk of unnecessary
segregation. Commenters noted that these practices place additional
terms and conditions on the receipt of certain benefits in integrated
settings that are not in place within segregated or institutional
settings, and that they can often delay care and cause unnecessary
institutionalization. For example, commenters asserted that people with
physical and sensory disabilities, complex medical needs, and people
with psychiatric and mental disabilities are often required to try less
expensive and often unsuccessful medication (i.e., step therapy) before
being able to access effective treatments in the community. If
utilization management techniques are only required for community-based
treatment and not for institutional care, commenters argued this may
push individuals urgently in need of care into institutional setting so
they can access treatment more quickly. In contrast, one commenter
suggested that it may be clinically appropriate to distinguish between
institutional settings and home and community-based settings (HCBS)
through the use of medical management
[[Page 37609]]
tools like prior authorization and step therapy due to closer
monitoring by medical professionals in institutional settings.
Response: OCR shares commenters' concerns about the potential
discrimination associated with the serious risk of
institutionalization. The integration mandates of the ADA and section
504 apply to people with disabilities who are at serious risk of
segregation or institutionalization, not only to people with
disabilities who are currently in institutions.\202\ For example, an
individual could show sufficient risk of institutionalization such that
it would constitute a violation of this provision if a covered entity's
failure to provide community services or its cut to such services will
likely cause a decline in health, safety, or welfare that result in the
serious risk of institutionalization or segregation.
---------------------------------------------------------------------------
\202\ See, e.g., Waskul v. Washtenaw Cnty. Cmty. Mental Health,
979 F.3d 426, 460-62, (6th Cir. 2020) (``Plaintiffs may thus state a
claim by sufficiently alleging that they are at serious risk of
institutionalization''); Steimel v. Wernert, 823 F.3d 902, 911-12
(7th Cir. 2016) (agreeing that the mandate applies to ``persons at
serious risk of institutionalization or segregation''); Davis v.
Shah, 821 F.3d 231, 262-64 (2d Cir. 2016) (``We thus hold that a
plaintiff may state a valid claim . . . by demonstrating that the
defendant's actions pose a serious risk of institutionalization for
disabled persons.''); Pashby v. Delia, 709 F.3d 307, 322 (4th Cir.
2013) (individuals state claims under the ADA and the Rehabilitation
Act when ``they face a risk of institutionalization''); M.R. v.
Dreyfus, 663 F.3d 1100, 1117-18 (9th Cir. 2011), amended by 697 F.3d
706 (9th Cir. 2012) (plaintiff must ``show that the challenged state
action creates a serious risk of institutionalization''); Fisher v.
Okla. Health Care Auth., 335 F.3d 1175, 1181-82 (10th Cir. 2003)
(plaintiffs who ``stand imperiled with segregation'' because of
state action may state a claim under the ADA's integration mandate);
but see U.S. v. Miss., No. 21-60772, 2023 WL 6138536, at *5-*9 (5th
Cir. Sep. 20, 2023) (rejecting the United States' at-risk Olmstead
claim).
---------------------------------------------------------------------------
As articulated in the Proposed Rule, 87 FR 47873, step therapy and
other utilization management practices that impose different standards
on members or beneficiaries in the community than in institutional
settings are discriminatory if the discrepancy results in unnecessary
segregation or a serious risk of unnecessary segregation. Section
1557's incorporation of section 504's integration provision through
Sec. 92.101(b)(1) makes clear that serious risk of
institutionalization is covered under section 1557 as well, given that
the vast majority of courts have found section 504 and title II of the
ADA prohibits actions, omissions, policies, and practices that place
individuals at serious risk of unjustified isolation. Indeed, nearly
every court of appeals to address the issue has held that the
integration mandate of the ADA and section 504 apply not only to people
with disabilities who are currently in institutions, but also to people
with disabilities who are at serious risk of segregation or
institutionalization.\203\ As noted in Fisher v. Oklahoma, the
integration mandate's ``protections would be meaningless if plaintiffs
were required to segregate themselves by entering an institution before
they could challenge an allegedly discriminatory law or policy that
threatens to force into segregated isolation.'' \204\ Likewise, section
1557's integration mandate would ring hollow if individuals were
required to show that they have already had to submit to
institutionalization in order to assert their right to receive services
in the most integrated setting appropriate to their needs.
---------------------------------------------------------------------------
\203\ See supra footnote 202 (citing cases).
\204\ 335 F.3d 1175, 1181 (10th Cir. 2003).
---------------------------------------------------------------------------
Further, even if a serious risk of unnecessary institutionalization
was not an actionable claim in and of itself, it would still be
appropriate for courts to grant relief to those at serious risk in
order to prevent the unnecessary institutionalization prohibited by
law.\205\ For these reasons, the rule's integration provision
explicitly prohibits benefit design that results in a serious risk of
institutionalization.
---------------------------------------------------------------------------
\205\ See, e.g., U.S. v. W.T. Grant Co., 345 U.S. 629, 633
(1953) (explaining that ``[t]he purpose of an injunction is to
prevent future violations'' and that such relief is appropriate
where there is a ``cognizable danger of recurrent violation.'').
---------------------------------------------------------------------------
Plans continue to be able to limit services, use utilization review
standards, and employ other limitations to manage costs as long as they
are not discriminatory in doing so.
OCR has revised the regulation text to clarify that the integration
requirement under section 1557 extends to practices that result in the
serious risk of institutionalization or segregation. We recognize that
the question of what constitutes ``serious risk'' is a fact-based
inquiry, which is why the Federal courts to have considered the
question have provided only general guidance on determining risk rather
than an exhaustive test.\206\
---------------------------------------------------------------------------
\206\ For example, in Davis v. Shah, 821 F.3d 231, 262-63 (2d
Cir. 2016), the court quoted DOJ, noting that ``a plaintiff `need
not wait until the harm of institutionalization or segregation
occurs or is imminent' '' to bring a claim under the ADA. A
plaintiff establishes a ``sufficient risk of institutionalization to
make out an Olmstead violation if a public entity's failure to
provide community services . . . will likely cause a decline in
health, safety, or welfare that would lead to the individual's
eventual placement in an institution.'' See also Waskul v. Washtenaw
Cnty. Cmty. Mental Health, 979 F.3d 426, 462 (6th Cir. 2020)
(finding ``declines in health, safety, or welfare'' as to sufficient
to show plaintiffs were at serious risk of institutionalization).
---------------------------------------------------------------------------
Comment: Several commenters strongly disagreed with the 2022 NPRM
preamble language that stated 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. Commenters noted that a
State Medicaid program or other covered entity may have to expand its
HCBS waiver programs or modify eligibility for particular services
where necessary to satisfy the integration provision, and that there
are many situations in which a State program has been required to
create a ``new'' community-based benefit, where that benefit was
previously only available in institutional settings. For example,
commenters stated that a covered entity that provides for residential
treatment for certain substance use disorder conditions and does not
provide coverage of such services in appropriate community-based
settings may need to create a ``new benefit'' by offering an existing
institutional benefit in the community.
Response: After considering these comments, we clarify here that
while a State Medicaid program is not required to create ``new''
programs to assist people with disabilities, nor are states required to
provide a particular standard of care or level of benefits, covered
entities must nevertheless adhere to section 1557's disability
nondiscrimination requirements--including the integration requirement--
with regard to the services they in fact provide. When a covered entity
chooses to provide a service, it must do so in a nondiscriminatory
fashion by ensuring access to that service in the most integrated
setting appropriate to the needs of the qualified individual.\207\
States may be required to offer services in an integrated setting that
they have only been offering in segregated settings; that is not
offering a ``new service,'' but instead is ensuring the service is
offered in integrated settings and not just in segregated
settings.\208\
---------------------------------------------------------------------------
\207\ See Olmstead, 527 U.S. 581, 603 (1999); see also
Radaszewski v. Maram, 383 F.3d 599, 609 (7th Cir. 2004) (citing
Olmstead, 527 U.S. at 603 n. 14, for the principle ``that States
must adhere to the ADA's nondiscrimination requirement with regard
to the services they in fact provide'') (``While `a State is not
obligated to create new services,' it `may violate Title II when it
refuses to provide an existing benefit to a disabled person that
would enable that individual to live in a more community-integrated
setting.''').
\208\ See U.S. Dep't of Justice, Civil Rts. Div., Statement of
the Dep't of Justice on Enforcement of the Integration Mandate of
Title II of the Americans with Disabilities Act and Olmstead v.
L.C., Question 8 (February 28, 2020), https://www.ada.gov/olmstead/q&a_olmstead.htm (stating that ``(p)ublic entities cannot avoid
their obligations under the ADA and Olmstead by characterizing as a
``new service'' services that they currently offer only in
institutional settings.''); see also Townsend v. Quasim, 328 F.3d
511, 517 (9th Cir. 2003) (``Here, the precise issue is not whether
the state must provide the long term care services sought by Mr.
Townsend and the class members--the state is already providing these
services--but in what location these services will be provided.'').
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[[Page 37610]]
OCR clarifies that a program providing community-based services
that are already available in institutional settings is not a new
program for purposes of evaluating a fundamental alteration
defense.\209\ In addition, states may be required to offer services in
an integrated setting that have only been offered in a segregated
setting. Providing services beyond what a State currently covers under
its Medicaid program may not be a fundamental alteration under Sec.
92.205 (Requirement to make reasonable modifications), and existing
nondiscrimination law, including section 504 and the ADA,\210\ may
require states to provide those services, under certain circumstances.
In addition, to the extent that a benefit, including an optional
benefit, is already provided in institutions as part of the State's
program, the same or a substantially similar benefit must be offered in
the community in a manner that does not incentivize institutional
services over community services.
---------------------------------------------------------------------------
\209\ See Townsend, 328 F.3d at 517 (``[c]haracterizing
community-based provision of services as a new program of services
not currently provided by the state fails to account for the fact
that the state is already providing those very same services. If
services were to constitute distinct programs based solely on the
location in which they were provided, Olmstead and the integration
regulation would be effectively gutted.'').
\210\ While this final rule periodically references the ADA and
section 504, the requirements under this rule are under section
1557, a separate legal authority. Accordingly, the integration
requirements, like other requirements under this section 1557 rule,
do not limit or impact the interpretation of integration
requirements under the ADA and section 504.
---------------------------------------------------------------------------
Comment: OCR received many comments in response to our request for
comment on the application of the integration provision to State
Medicaid programs. A number of comments related to Medicaid program
designs required by title XIX of the Social Security Act. One commenter
recommended that any action by a State Medicaid authority to reduce the
existing scope of Medicaid-funded home and community-based long term
services and supports, or to more strictly limit eligibility for them,
that would have the effect of forcing people with disabilities who
currently do, or could, live in their own homes and participate in
unrestricted community activities into segregated, congregate, and/or
institutional residential or day settings, or to cease their current
level of community participation, on the basis of any general
categorization of disability would be discriminatory under this
provision.
Response: We appreciate the many comments highlighting potential
issues related to community integration and State Medicaid programs.
This rule does not impact the ability of states to target benefits
under section 1915(c), section 1915(i), or section 1937 of the Social
Security Act, consistent with Medicaid law. At the same time, the fact
that a State chooses to use a Medicaid authority to target a particular
disability population does not relieve a State of its obligations
towards other populations. We will continue to work with our partners
in CMS to ensure the robust provision of services in a
nondiscriminatory manner to the maximum extent possible. We remind
covered entities that obligations under the Medicaid statute are
distinct from obligations under section 1557, and compliance with
Medicaid requirements does not per se constitute compliance with
section 1557.
Comment: A significant number of commenters raised concerns with
``use-in-the-home'' policies, where an insurance issuer will cover the
provision of a benefit or service solely for use ``in the home.'' For
example, commenters discussed that a covered entity might offer
supplemental oxygen equipment for use in the home but decline to
provide sufficient oxygen or equipment for an individual to access the
broader community. Similarly, commenters noted that issuers might
decline to cover medically necessary wheelchairs with functions that an
individual needs to access the broader community outside their home.
Commenters also provided examples of other kinds of medical diagnostic
equipment, durable medical equipment, and home-use devices that are
often not covered, but which would replace services provided in an
institution and enable individuals to receive care in their home and
community.
Commenters expressed concern that many State Medicaid programs,
delegated managed care companies, and employer-sponsored private health
plans have adopted the Medicare Mobility Assistive Equipment Coverage
Policy \211\ (a policy designed specifically to apply in the context of
Medicare Part B) as their policy, despite what commenters see as the
statutory differences between Medicare Part B and other authorities.
Commenters contended that the unnecessary and unmandated adoption of
such a policy in all programs unnecessarily restricts benefits to a low
bar, denying people the ability to live in the most integrated setting
possible.
---------------------------------------------------------------------------
\211\ U.S. Dep't of Health & Hum. Servs., Ctrs. for Medicare &
Medicaid Servs., National Coverage Determination, Mobility Assistive
Equipment (MAE) (2005), https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=219.
---------------------------------------------------------------------------
Response: We appreciate the concerns raised by commenters. Each
covered entity should review any legal authority governing the coverage
they may provide to ensure that they are not interpreting it in a
manner that results in discrimination. For example, Medicaid programs
that impose homebound or ``in-the-home'' criteria that are not
statutorily required under Federal law may be unnecessarily restricting
services in the community in violation of civil rights laws. Where an
in-the-home restriction is included in a statute, covered entities may
not automatically deny coverage for any good or service that may also
have use outside of the home, but must assess each claim to determine
whether the denial will violate the most integrated setting
requirement.
Comment: Many commenters expressed the need for Sec. 92.207(b)(6),
due to states increasingly turning to managed care plans to deliver
Medicaid benefits. These commenters expressed concern that large
issuers that administer a range of private employer plans and
individual plans, as well as public Medicare and Medicaid plans, could
employ uniform coverage policies across their plans that do not
adequately support community integration. Commenters additionally noted
that that Medicaid agencies should monitor whether Medicaid Managed
Care Organizations (MCOs) are appropriately authorizing services in the
community and that under current law states contracting with MCOs
cannot escape liability when MCOs discriminate against people with
disabilities.
Response: We appreciate the concerns raised by commenters. We
recognize the increasing reliance on alternative payment models for the
delivery or management of services to individuals with disabilities.
The shift towards managed care in State Medicaid programs and other
changes, such as quality incentives, quality assurance activities, and
risk-sharing arrangements, requires addressing unnecessary segregation
in these emerging models in this rule.
As we noted in the Proposed Rule, 87 FR 47873, covered entities
designing contracts with MCOs, pharmacy benefit managers, or other
third-party entities taking on financial risk for the delivery of
health services should carefully scrutinize their capitation,
[[Page 37611]]
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 institutionalization or segregation. When responsibility for
services is shared across multiple entities, for example, under a
managed care contract, both the State Medicaid agency and the
contracted entity have obligations under this provision if they are
both recipients of Federal financial assistance.
Comment: Many commenters discussed challenges related to mental
health services, noting that the lack of available and funded community
alternatives to institutional mental health care will continue to
result in the institutionalization of individuals with serious mental
illness, whether in hospitals, inpatient psychiatric facilities,
prisons, or other secure facilities.
Many commenters voiced concern related to discharge planning, as
people requiring intensive mental health services are often referred
only to institutional or otherwise congregate care options, rather than
comparably intensive services in community-based settings. Commenters
recommended that OCR clarify that this can constitute a violation of
the integration provision if it forces people with psychiatric
disabilities to enter segregated settings in order to receive access to
adequate services.
Other commenters discussed the disparity in access to community-
based care for children who need mental health care.
Response: OCR appreciates the significant concerns related to the
availability of community-based behavioral health services,
particularly services to address youth mental health. With respect to
discharge planning, a hospital or acute care provider that routinely
discharges individuals with disabilities, including those with serious
mental illness, to nursing homes, psychiatric residential treatment
facilities, or other segregated care settings due to discharge planning
procedures that do not assess for home-based support services or refer
individuals to community-based providers may violate this provision.
Covered entities are prohibited from implementing planning, service
system design, and service implementation practices that result in the
serious risk of institutionalization or segregation.
Comment: Several commenters provided insight into the relationship
between community integration and reimbursement rates necessary to
sustain a direct care workforce. Commenters explained that individuals
receiving care in the community often fail to receive all of the hours
of care for which they are approved due to a lack of provider capacity
to fully staff the approved hours. Commenters noted that nurse's aides
and other individuals who provide assistance in institutional settings
are often paid at a higher rate than home health aides and other direct
care professionals, resulting in an imbalanced direct care workforce.
Commenters emphasized the importance of rate setting to incentivize
HCBS.
Response: Reimbursement rates and network adequacy both constitute
methods of program administration. As such, these are factors that OCR
would consider as reimbursement practices or methods of administration
related to this provision.
Comment: Commenters suggested additional guidance clarifying
implementation of this provision, including incorporating DOJ's
guidance on enforcement of the integration requirement under title II
of the ADA describing how to provide the most integrated setting
appropriate for an individual or group of individuals; \212\ addressing
the remedies available for violations of the integration provision; and
explaining how OCR will undertake a fundamental alteration analysis.
One commenter recommended incorporating the fundamental alteration
defense into regulatory text. Commenters underscored the importance of
setting a high bar for a fundamental alteration, noting that programs
must alter an essential aspect of the health program or activity. Other
commenters urged OCR to clarify how the fundamental alteration analysis
applies to the integration provision, including whether and how OCR
will incorporate DOJ guidance and case law related to the ADA's
fundamental alteration defense for ADA title II entities. Commenters
also requested clarification on whether covered entities will be
required to establish an Olmstead integration plan \213\ to raise the
fundamental alteration defense, and if so, guidance related to that
requirement.
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\212\ U.S. Dep't of Justice, Civil Rts. Div., Statement of the
Dep't 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.
\213\ Under the ADA, an Olmstead plan is a public entity's plan
for implementing its obligation to provide individuals with
disabilities opportunities to live, work, and be served in
integrated settings. U.S. Dep't of Justice, Civil Rts. Div.,
Statement of the Dep't 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.
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Commenters also asked OCR to explain in future guidance how covered
entities, including Medicaid programs, must coordinate community-based
primary care and specialty mental health care and offer case management
to avoid discrimination on the basis of disability and to avoid placing
individuals with mental disabilities at serious risk of
institutionalization.
Commenters further suggested guidance to covered entities
explaining the specific HCBS that are essential to achieving compliance
with the integration requirement, including as part of EHB. Commenters
suggested that it would be discriminatory if EHB plans set higher
reimbursement rates for a service or item for individuals in segregated
settings rather than community-based settings; if rehabilitation
services for physical conditions are covered, but not psychiatric
rehabilitation services; and if a particular benefit (such as personal
care services) is offered in greater amounts to individuals in
segregated settings by virtue of the plan benefit design.
Finally, commenters encouraged OCR to develop joint guidance with
DOJ on section 1557, section 504, and titles II, III, and IV of the ADA
to ensure the rights of people with disabilities to access community
integration in health care settings.
Response: We appreciate the comments requesting clarification
through sub-regulatory guidance. We will consider future guidance after
this rule has been finalized and are committed to our continued
partnership with DOJ in developing shared guidance on civil rights
requirements. The availability of the fundamental alteration defense is
clear as drafted and so we decline to specifically incorporate this
recommendation into regulation text. In this final rule, we clarify
that a program is not required to provide coverage for a service in the
most integrated setting appropriate to an individual's needs if it
would fundamentally alter the program to do so.
Comment: Commenters, primarily representatives of the insurance
industry, supported proposed Sec. 92.207(c) that specified 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
[[Page 37612]]
requirements, such as medical necessity requirements, in an individual
case. Commenters appreciated that OCR acknowledged that a covered
entity's legitimate, nondiscriminatory reason for its actions may serve
as a defense under this section.
Some commenters requested clarification that use of the phrase
``legitimate, nondiscriminatory reason'' not be construed in any way to
limit the method of proof for any section 1557 claim to the McDonnell
Douglas burden-shifting framework; that this method cannot be used to
defend an express sex classification that causes injury; that the
familiar but-for causation test applies to establishing a violation of
section 1557; and that the McDonnell Douglas burden-shifting framework
and legitimate nondiscriminatory reason framework apply to
circumstantial evidence cases but not where there is direct evidence of
discrimination.
Response: OCR appreciates commenters' support of this provision. As
discussed throughout this section and in the Proposed Rule, in
instances where there is not a facially discriminatory policy and OCR
is investigating whether a particular action or practice is
discriminatory under this rule, covered entities have the opportunity
to defend the challenged action or practice by providing a legitimate,
nondiscriminatory reason for its actions that is not pretext for
discrimination. OCR will then evaluate whether the reason given by the
covered entity is a pretext for prohibited discrimination. When
considering whether a proffered reason is pretextual, OCR will
consider, among other things, whether a denial of a health service is
based on medical necessity standards or other reasonable medical
management techniques that are not discriminatory, as discussed in more
detail below.
To provide additional clarity about OCR's analysis when evaluating
whether a covered entity's legitimate, nondiscriminatory reason is
pretextual, OCR is revising Sec. 92.207(c) to state that a covered
entity's denial or limitation of a health service must not be based on
unlawful animus or bias, or constitute a pretext for discrimination.
This modification is consistent with the revised language in Sec.
92.206(c). Under either section, in instances where there is no
evidence of a facially discriminatory policy, covered entities may
assert a legitimate, nondiscriminatory basis for actions that could
otherwise give rise to the inference of discrimination. Consistent with
general principles of civil rights law, OCR will consider such asserted
bases but may also investigate to determine whether such asserted bases
are pretextual and whether there is evidence that the challenged action
was taken because of unlawful animus, bias, or other discriminatory
factors.
In evaluating claims of discrimination, OCR relies on general
nondiscrimination principles and longstanding civil rights case law.
Such principles include, but are not limited to, the multi-factor test
articulated in Arlington Heights and the McDonnell Douglas burden-
shifting framework, which were discussed in detail in the Proposed Rule
at 87 FR 47865. Arlington Heights sets forth a method of proof that
utilizes different types of evidence that collectively may demonstrate
that a covered entity acted, at least in part, because of a protected
basis. The McDonnell Douglas burden-shifting framework is an
inferential method of proof used to show that a covered entity treated
similarly situated individuals differently because of a protected
basis. Under McDonnell Douglas, where non-facial evidence of
discrimination exists, a covered entity must articulate a legitimate,
nondiscriminatory reason for its actions. The entity's legitimate,
nondiscriminatory reason may refute the evidence of discrimination,
unless it can be established that this reason is a mere pretext for
prohibited discrimination. In response to the commenters' concerns
about how Sec. 92.207(c) may be interpreted inconsistently with the
principles set forth in McDonnell Douglas and other civil rights
principles, please see our response to the same comments under Sec.
92.206 in which we affirm commenters' interpretations are correct--
McDonnell Douglas' burden-shifting framework and legitimate
nondiscriminatory reason framework apply to circumstantial evidence
cases but not in cases where there is direct evidence of discrimination
based on a facially discriminatory policy.
Comment: Some commenters appreciated OCR clarifying that medical
management techniques based on clinical evidence are permitted,
including the use of reasonable medical necessity and utilization
management techniques based on clinical standards and evidence-based
guidelines, when applied in a neutral manner. Commenters noted that
medical management tools provide an important role in promoting quality
care and reducing health care costs.
Other commenters raised concerns about medical necessity criteria
and other medical management tools, noting that such tools may limit
access to needed services and treatment. Commenters noted that
discriminatory decisions often occur under the guise of medical
necessity determinations. Some commenters argued that medical
management practices such as prior authorization, step therapy, and
durational or quantity limits are inherently discriminatory and
inconsistent with patient health and safety. Many commenters strongly
supported OCR clarifying that excessive use or administration of
benefit utilization management tools that target particular
disabilities could violate section 1557. Commenters asked OCR to
expressly note the limitation on the use of utilization management
tools in the text of the regulation.
Commenters asked OCR for examples of excessive medical management
and suggested the following examples: requiring step therapy for new
enrollees who are already on a working course of treatment;
transferring management of particular medicines to niche vendors that
apply more extensive medical management through specialty carve-out
programs; requiring the use of off-label medications within step
therapy; and imposing categorical prior authorization and step therapy
requirements on most or all drugs required to treat a particular
disease. Commenters noted that issuers apply such medical management
techniques to discourage individuals with high-cost needs from
enrolling in their plans. A commenter cited evidence that plans have
restricted access to lower-cost brand drugs and generics when demand
for those drugs attracts patients who have overall high health
costs.\214\ Other commenters noted that information about treatment
limitations can be difficult to find for enrollees and cited evidence
of issuers building arbitrary coverage denials into their business
plans.\215\ Commenters cited a study that found that more than half of
step therapy policies developed by commercial health plans were more
[[Page 37613]]
restrictive than recommended clinical guidelines.\216\
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\214\ Michael Geruso et al., Screening in Contract Design:
Evidence from the ACA Health Insurance Exchanges, 11 a.m. Econ. J.:
Econ. Pol. 2, 64-107 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8130799/.
\215\ Karen Pollitz et al., Claims Denials and Appeals in ACA
Marketplace Plans in 2021, Kaiser Family Found. (2022), https://www.kff.org/private-insurance/issue-brief/claims-denials-and-appeals-in-aca-marketplace-plans/ (finding nearly 17 percent of in-
network claims in non-group qualified health plans were denied in
2021; insurer denial rates varied widely around this average,
ranging from 2 to 49 percent; about 14 percent were denied because
the claim was for an excluded service, 8 percent were due to lack of
preauthorization or referral, 2 percent were based on medical
necessity, and 77 percent were classified as ``all other reasons'').
\216\ Kelly L. Lenahan et al., Variation in Use and Content of
Prescription Drug Step Therapy Protocols, Within and Across Health
Plans, 40 Health Affairs 11, 1749-57 (2021), https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2021.00822?journalCode=hlthaff (finding that plans applied
step therapy in 38.9 percent of drug coverage policies, with varying
frequency across plans (20.6-57.5 percent); 34.0 percent were
consistent with corresponding clinical guidelines, 55.6 percent were
more stringent, and 6.1 percent were less stringent).
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Some commenters requested that OCR revise the text of Sec.
92.207(c) to state that, in addition to medical necessity requirements,
covered entities may employ reasonable medical management techniques.
Response: OCR appreciates the variety of comments and
recommendations put forth by commenters related to the rule's coverage
of medical management techniques, including medical necessity standards
and utilization management techniques.
OCR agrees that revising the regulatory text to reference
reasonable medical management techniques would provide clarity and
would be consistent with other provisions in the ACA and the Proposed
Rule. Therefore, OCR is revising Sec. 92.207(c) to state that
applicable coverage requirements include reasonable medical management
techniques, including medical necessity.
Further, as stated in the Proposed Rule, covered entities are not
prohibited from employing reasonable medical management techniques as
long as they are not discriminatory and are not otherwise prohibited
under other applicable Federal and State law. 87 FR 47873-74. As just
one example, covered entities participating in the Medicaid program
under title XIX of the Social Security Act are not prohibited from
implementing nondiscriminatory utilization management techniques, such
as prior authorization.\217\
---------------------------------------------------------------------------
\217\ See, e.g., 42 U.S.C. 1396r-8(d).
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Under Sec. 92.207(c), an issuer may assert a legitimate,
nondiscriminatory reason for its denial or limitation of coverage of a
health service that asserts the denial was based on medical necessity
standards--or any other medical management technique. When assessing
whether the challenged action was based on prohibited discrimination
rather than on nondiscriminatory medical necessity standards, OCR will
review a medical necessity determination only to make sure that it is a
bona fide medical judgment, not conduct a review of the medical
judgment underlying the medical necessity determination, but rather
will assess whether the rationale for the denial was based on
impermissible discriminatory considerations. In its review, OCR may
require a covered entity to provide the following information: its
medical necessity standards or guidelines; the clinical, evidence-based
criteria or guidelines \218\ relied upon to make the medical necessity
determination; and the medical substantiation for the medical necessity
determination. As discussed previously, OCR will evaluate a covered
entity's assertion that its actions were based on legitimate,
nondiscriminatory reasons to determine if it is pretextual. Medical
necessity determinations that are not based upon general medical
judgments or based on clinical, evidence-based criteria or guidelines
may be considered evidence of pretext for discrimination.
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\218\ See also 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 [EHB] is one that is clinically-based'').
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Similarly, as noted in the Proposed Rule, 87 FR 47872, we affirm
that covered entities are not prohibited from using other reasonable
medical management techniques, such as utilization management tools,
when applied in neutral, nondiscriminatory manner and not otherwise
prohibited under other applicable Federal and State law. Utilization
management techniques include prior authorization,\219\ step therapy
(or ``fail-first''),\220\ and durational or quantity limits.\221\
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\219\ 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.
\220\ 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.
\221\ 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.
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OCR shares commenters' concerns about potentially discriminatory
practices related to medical management techniques and the negative
impacts of excessive utilization management. As such, when relying on
medical necessity requirements and other medical management techniques
to deny coverage for a health service, covered entities must ensure
that such tools are developed and applied in a neutral,
nondiscriminatory manner. OCR would have concerns about guidelines that
establish more restrictive requirements for certain diseases or
conditions without a nondiscriminatory justification. In addition, OCR
expects that limitations within such guidelines should be applied
consistently with clinical standards within each patient population
disease state, condition level, and diagnostic category to ensure equal
clinical treatment across protected bases. That is, all patients
diagnosed with a particular disease state must receive the same
treatment that is deemed clinically appropriate, regardless of their
race, color, national origin, sex, age, or disability.
We affirm that excessive use or administration of utilization
management practices that target a particular condition that could be
considered a disability or other prohibited basis under section 1557
could be discriminatory under this rule. OCR declines to state in
preamble or regulatory text that specific practices are per se
discriminatory under section 1557. As discussed throughout this
section, OCR must conduct a fact-specific inquiry into allegations of
discriminatory actions and consider a covered entity's proffered reason
for the challenged action.
Comment: OCR received a number of comments discussing costs as a
legitimate, nondiscriminatory reason for benefit designs under Sec.
92.207(c). Commenters supported the rule allowing clinical evidence to
support a benefit design and requested that OCR allow covered entities
to use extraordinary costs as justification for certain benefit
designs. Commenters stated that covered entities use utilization
management controls, such as drug tiering, as part of their benefit
design to keep coverage affordable. Commenters noted concerns that
high-cost drugs or other services could lead to health plans becoming
insolvent if they are unable to apply utilization management controls
where all treatments for a particular condition are high cost,
particularly when they are expensive new drugs or gene therapies.
Commenters argued that issuers and plans must retain some flexibility
in their approach to covering and paying for high-cost drugs and
services. Commenters expressed concern that Sec. 92.207 would prohibit
covered entities from having utilization management controls on all or
most drugs or services
[[Page 37614]]
that treat a particular condition or disease, regardless of their cost,
and asked OCR to affirm that placing all treatments for a certain
disease or condition in one tier may not in fact be discriminatory by
default, but rather an appropriate benefit design due to the high cost
of those particular items or services.
Conversely, other commenters asked OCR to clarify that covered
entities cannot justify benefit designs that disfavor coverage for
medically necessary services based on cost savings. Commenters noted
that as costs of medications and therapies have increased, covered
entities have significantly increased the use of utilization
management, including adding arbitrary prior authorization processes
not based in clinical evidence for new cancer therapies. They added
that rare disease patients face the additional challenge of having no
or few treatment alternatives if a preferred medication or therapy is
not covered.
Response: OCR reiterates that Sec. 92.207 does not prohibit a
covered entity from engaging in reasonable utilization management
techniques applied in a neutral, nondiscriminatory manner and that are
not otherwise prohibited under other applicable Federal and State law.
As noted above, 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. Where there is an alleged discriminatory practice or action that
is not based on a facially discriminatory policy, Sec. 92.207(c)
provides that the covered entity has the opportunity to provide a
legitimate, nondiscriminatory reason for the practice. Covered entities
are not restricted in what information they elect to provide to OCR as
part of their justification for the challenged practice or action. OCR
will carefully review a covered entity's proffered reason to ensure it
is not pretext for discrimination.
OCR discussed previously that determinations on whether a
particular benefit design feature is discriminatory, such as
utilization management or drug tiering, will be made on a case-by-case
basis. Accordingly, OCR declines to specify whether certain benefit
design practices are per se discriminatory.
Comment: One organization raised concerns that OCR is asserting de
facto authority over the relationship between health insurance and
medical care, and that OCR is asserting that it has authority under
section 1557 to regulate the practice of medicine and the structure of
health insurance coverage according to its own determination of what is
``appropriate'' and ``nondiscriminatory,'' along with the authority to
definitively determine what is, or is not, the current standard of
medical care. The commenter further states that OCR may in the future
assert and exercise similar claims of authority with respect to other
medical practices, standards of care, or health insurance coverages.
Response: As previously discussed throughout this preamble, section
1557 was intended to prohibit discrimination in health insurance
coverage and other health-related coverage, as the statute's plaint
text makes apparent. Congress expressly granted the Secretary the
authority to promulgate regulations to implement section 1557. 42
U.S.C. 18116(c). Therefore, OCR is acting within its statutory
authority in promulgating this final rule to regulate health insurance
coverage or other health-related coverage provided or administered by a
recipient health insurance issuer or other covered entity. OCR
disagrees with the commenter that this rule establishes a standard of
medical care, or requires certain health insurance coverages. As
specified in the preceding discussion, when assessing whether a
challenged action was based on prohibited discrimination rather than on
nondiscriminatory medical necessity standards, OCR will not conduct a
general review of the medical judgment underlying the medical necessity
determination, but rather will assess whether there is facial or other
direct evidence of discriminatory intent or if a proffered rationale
for the denial was pretext for discrimination. Further, this final rule
does not require coverage of a particular health service; rather, it
requires that the coverage being offered must be provided in a neutral
and nondiscriminatory manner.
Comment: Commenters stated that issuers should provide transparent
information on coverage details, utilization management practices,
denial rates, and reasons for denials. Specifically, a commenter
requested that this section be strengthened by implementing a
requirement for health plans to disclose medical necessity
determinations when care or coverage is denied based on medical
necessity to individual enrollees. The commenter further suggested that
OCR adopt the approach in the MHPAEA final rule, requiring disclosure
of medical necessity criteria to potential beneficiaries or enrollees
and the reasons behind denials of coverage or reimbursement. Commenters
emphasized that disclosure would help providers and consumers to
identify and challenge discriminatory denials of medically necessary
care, which can be difficult to do when data regarding the coverage
they need either does not exist or the issuer holds the data on details
of coverage, denial rates, and reasons for denial.
Response: OCR agrees with commenters that transparency about
medical management policies and coverage determinations and denials is
useful information for the public, and we encourage issuers to disclose
such information to all enrollees. OCR considered requiring issuers to
affirmatively disclose certain plan information to the public, but we
decline to do so at this time. We have determined that placing a
transparency requirement on health insurance issuers covered under
section 1557 would not be helpful on issuers if required in every
situation, and because the scope and application of section 1557 is
broader than, and imposes different requirements from, MHPAEA. We
stress that OCR has the authority to request and receive information
from a covered entity on the details of coverage, medical management
policies, denial rates, and reasons for denials, among other things,
when necessary to determine compliance with section 1557.\222\ In
addition, we note that appeals processes that subject individuals
protected by section 1557 to excessive administrative burdens in
accessing coverage benefits that other enrollees are not required to
navigate when accessing coverage may be discriminatory under section
1557.
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\222\ 45 CFR 92.303 (section 1557); 80.6 (title VI); 84.61
(section 504, incorporating title VI's Sec. 80.6); 86.71 (title IX,
incorporating title VI's Sec. 80.6); 91.34 (Age Act).
---------------------------------------------------------------------------
Comment: OCR received many comments on the use of value assessment
methods in benefit design and pricing and coverage decisions, and their
impacts on treatments for people with disabilities and older adults,
particularly in access to prescription drugs and benefit design.
Commenters suggested that some payers use these assessment methods to
steer patients away from newer or more innovative treatments to less
effective options. Commenters on this issue appreciated OCR's
recognition in the Proposed Rule that these methods can have
discriminatory impacts, though commenters did not provide uniform input
about how to address these impacts.
Several commenters called for increased oversight of value
assessment methods by OCR, and some called on OCR to ban the use of the
quality-
[[Page 37615]]
adjusted life year (QALY) framework and similar methods. Commenters
supporting a ban on the use of QALYs stated that these methods are
inherently discriminatory because they assign a lesser numerical value
to extending the lives of people with disabilities and older adults
compared to people without disabilities or younger persons, especially
when applied to benefit design or access to prescription drugs.\223\
---------------------------------------------------------------------------
\223\ These concerns were also highlighted in testimony at a
recent Congressional hearing on proposed legislation to ban the use
of QALYs in all Federal health programs. See Lives Worth Living:
Addressing the Fentanyl Crisis, Protecting Critical Lifelines, and
Combatting Discrimination Against Those with Disabilities: Hearing
on H.R. 467, H.R. 498, H.R. 501, and H.R. 485 Before the Subcomm. on
Health of the H. Comm. on Energy & Com., 118th Cong. (2023)
(statement of Kandi Pickard, President & CEO, Nat'l Down Syndrome
Society), https://d1dth6e84htgma.cloudfront.net/Witness_Testimony_Pickard_HE_02_01_2023_065c903370.pdf?updated_at=2023-01-30T21:38:38.787Z (speaking on her support of Protecting Health
Care for All Patients Act, H.R. 485, 118th Cong. (2023)).
---------------------------------------------------------------------------
Response: OCR recognizes that value assessment methods can be
helpful tools in making decisions in various contexts within health
care and are used widely. The use of value assessment methods that
result in discrimination on the basis of race, color, national origin,
age, disability and sex are prohibited under section 1557's general
mandate of nondiscrimination. That is, where a value assessment uses
methods that penalize patients or groups of patients on a ground
protected by section 1557 and where such methods then result in
limiting access to an aid, benefit, or service, they may violate
section 1557. In response to commenters, we note that value assessment
tools cannot be used to, to deny or afford an unequal opportunity to
qualified individuals with disabilities or on the basis of age with
respect to the eligibility or referral for, or provision or withdrawal
of any aid, benefit, or service, including the terms or conditions
under which they are made available. We further note that methods of
value assessment are permissible so long as they do not discriminate in
discounting the per-year value of life extension on the basis of age or
disability under section 1557.
In addition, OCR has proposed a prohibition against the
discriminatory use of value assessment methods in pending rulemaking
under section 504. 88 FR 63409. Proposed Sec. 84.57, which applies to
recipients of Federal financial assistance from HHS, prohibits,
directly or through contractual, licensing, or other arrangements,
using any measure, assessment, or tool that discounts the value of life
extension on the basis of disability to deny or afford an unequal
opportunity to qualified individuals with disabilities with respect to
the eligibility or referral for, or provision or withdrawal of any aid,
benefit, or service, including the terms or conditions under which they
are made available.
Given that many different measures exist for use in value
assessment and may be applied in different ways, this discussion
applies to evaluating any value assessment methodology rather than
commenting on specific measures at this time. However, we appreciate
the concerns raised by the commenters and will take them into account
as OCR proceeds with future work on value assessment.
Comment: Many comments on value assessment also requested further
development of new value assessment measures and the incorporation of
input from patients with disabilities (and, per some commenters, their
family members and providers) into value assessment schema. Commenters
urged the Department to support the development and dissemination of
these methodologies. Another commenter noted that cultural barriers
existed in institutions that prevented the adoption of new metrics.
Response: OCR appreciates commenters' input and encourages and
supports the development of such metrics and the incorporation of input
from people with disabilities and other interested groups protected
under section 1557, as reflected in research priorities elsewhere in
the Department. Numerous research and grantmaking initiatives from the
National Institutes of Health (NIH) and the National Institute on
Disability, Independent Living, and Rehabilitation Research (NIDILRR)
support this and similar efforts.\224\ In addition, OCR notes that the
National Council on Disability issued an updated policy brief released
in November 2022.\225\
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\224\ Funding Opportunity Announcement, U.S. Dep't of Health &
Hum. Servs., Nat'l Insts. of Health, NIH Faculty Institutional
Recruitment for Sustainable Transformation (FIRST) Program: FIRST
Cohort (U54 Clinical Trial Optional) (December 8, 2020), https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-20-022.html; U.S. Dep't
of Health & Hum. Servs., Adm. for Cmty. Living, Disability and
Rehabilitation Research Projects (DRRP) Program, https://acl.gov/programs/research-and-development/disability-and-rehabilitation-research; U.S. Dep't of Health & Hum. Servs., Nat'l Insts. of
Health, All of Us Research Program, https://allofus.nih.gov/.
\225\ Nat'l Council on Disability, Alternatives to QALY-Based
Cost-Effectiveness Analysis for Determining the Value of
Prescription Drugs and Other Health Interventions (2022), https://www.ncd.gov/report/alternatives-to-qaly-based-cost-effectiveness-analysis-for-determining-the-value-of-prescription-drugs-and-other-health-interventions/.
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Benefit Design Analysis
The comments and our responses regarding benefit design are set
forth below.
In the Proposed Rule, we discussed that OCR will apply basic
nondiscrimination 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. We discussed
that, 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, and that OCR will scrutinize the justification to ensure it
is not a pretext for discrimination.
Comment: Some commenters requested that OCR provide additional
guidance explaining how it intends to investigate potential violations
by health programs or activities engaged in providing or administering
health insurance coverage or other health-related coverage and to
ensure ongoing compliance with Federal law. Commenters urged OCR to
establish clear, predictable standards that covered entities can rely
upon when designing their plans and that will ensure OCR's ``case-by-
case'' analysis does not result in only retroactive reviews of existing
plans or lead to arbitrary results.
Another commenter noted that if OCR will not provide presumptively
discriminatory benefit design examples, OCR should provide more
information to educate covered entities about what OCR interprets to be
best practices other than the information, corrective plans, and
resolution agreements it stated it would publish on its website in the
2016 Rule. The commenter urged OCR to publicly publish deidentified
information on each and every investigation that it pursues, including
the specific actions purported to be discriminatory by a covered
entity, the alleged basis of discrimination, and OCR's resolution of
the complaint so that covered entities can educate themselves on best
practices and actions that OCR may deem to be discriminatory.
Response: We appreciate the comments requesting further specificity
regarding OCR's analysis when investigating potential violations under
this section. We agree that providing clarity to covered entities
promotes compliance and reduces prohibited discrimination. Each
potentially discriminatory action involves unique
[[Page 37616]]
facts and circumstances that must be independently investigated on a
case-by-case basis before OCR can determine whether a challenged action
is considered discriminatory under this section, particularly
considering that each covered entity's reason for engaging in the
challenged action may be specific to that covered entity and the
circumstances surrounding its decision process. For example, when
determining whether a challenged design feature is discriminatory, OCR
considers the benefit design of the plan as a whole, whether similar
limitations or restrictions are placed on other types of health
services, and whether the covered entity consistently relies on
neutral, nondiscriminatory criteria when developing the design feature,
among other things. Therefore, OCR reaffirms the investigative approach
set forth in the Proposed Rule, 87 FR 47875, whereby OCR's
determination of whether a challenged action is discriminatory is
necessarily a fact-specific, case-by-case analysis dependent on the
facts of the particular situation. When analyzing whether an action
violates this section, OCR will apply basic nondiscrimination
principles to the facts of the particular health insurance coverage or
other health related coverage, consistent with civil rights case law.
This includes the opportunity for covered entities to articulate a
legitimate, nondiscriminatory justification for an alleged
discriminatory action, which OCR will scrutinize to ensure it is not a
pretext for discrimination. Where a covered entity's justification
relies upon medical standards or guidelines, we note that such
standards or guidelines may be subject to additional scrutiny if they
are not based on clinical, evidence-based criteria or guidelines. For
more information related to OCR's consideration of a covered entity's
legitimate, nondiscriminatory reason, please see previous discussion
under Sec. 92.207(c).
OCR reiterates that this rule does not require a covered entity to
provide coverage for any particular health service in its health
insurance coverage or other health-related coverage when provided in a
nondiscriminatory manner; however, to the extent a covered entity
provides coverage for a particular health service, the covered entity
must provide the health service to all individuals in a neutral,
nondiscriminatory manner consistent with this rule.
Regarding our analysis when investigating potential discrimination
in the benefit design of excepted benefits and short-term, limited
duration insurance (STLDI), we provide additional information below in
the discussion under this section on Scope of Application to Health
Insurance and Health-Related Coverage (Including Excepted Benefits and
STLDI).
OCR acknowledges that the nature of our complaint-driven
investigative process results in OCR reviewing existing plans and
making determinations on the benefit designs of existing plans.
However, OCR's case-by-case analysis is necessary in order to consider
the fact-specific nature of each challenged action and to apply
relevant case law to each situation. OCR investigates each allegation
in a consistent manner and treats all complainants and covered entities
evenly.
We appreciate commenters' suggestions to provide more information
to educate covered entities about what OCR interprets to be best
practices; OCR will consider issuing such guidance in the future. To
educate both the public and covered entities, OCR posts its resolution
agreements on its website and issues press releases when cases are
resolved, and we intend to continue this practice.
Comment: Commenters recommended that OCR specify in the final rule
that a nondiscriminatory benefit design is one that is clinically
based. While expressing support for OCR considering clinical guidelines
and standards of care when evaluating plan benefit designs, these same
commenters also cautioned that OCR should not exclusively rely on
clinical guidelines and journal articles in its analysis of
discriminatory design because clinical guidelines may perpetuate racial
bias and health disparities, and entities could cite a single peer-
reviewed article as a shield to escape valid claims of discriminatory
benefit design.
Response: An analysis of whether a benefit design is discriminatory
under this rule is a fact-specific inquiry that will be made in
accordance with general civil rights principles and applicable case
law. As discussed under Sec. 92.207(c), covered entities may provide a
legitimate, nondiscriminatory reason as a defense to a potentially
discriminatory coverage determination. A covered entity has latitude to
submit any legitimate reason for its actions as long as it is not
discriminatory or pretext for discrimination. However, if the
justification given is not based on clinical, evidence-based criteria
or guidelines, OCR will consider that evidence of pretext. When a
covered entity submits a justification that relies upon medical
standards or guidelines, OCR may conduct additional investigation to
ensure the justification is not pretextual, including a review on
whether the standards or guidelines are or are not based on clinical,
evidence-based criteria or guidelines. OCR's review of a covered
entity's justification will not rely solely on a covered entity's
provision of one piece of literature but will consider a variety of
factors, as discussed in detail above under Sec. Sec. 92.206(c) and
92.207(c). We further note that OCR will not conduct a general medical
review of the medical judgment undergirding the determination.
Comment: Commenters noted that OCR could ensure higher quality
health care for all enrollees through stronger oversight and
regulation. These commenters urged OCR not to rely solely on complaints
and to engage in proactive oversight by affirmatively reviewing covered
entities' plan designs.
Response: We agree that robust enforcement of section 1557 is
critical to ensure individuals' ability to receive medically necessary
health services, unencumbered by discriminatory conduct. OCR will
employ all available means of investigating health insurance coverage
and other health-related coverage under this rule, including through
compliance reviews and complaint investigations.
Comment: Commenters requested that OCR clarify how it will
coordinate with State and Federal agencies that establish specific plan
requirements and approval processes. Commenters noted that many facets
of benefit design are heavily regulated by other agencies within the
Department, including CMS' regulation of nondiscriminatory plan design
in EHB and qualified health plans, retail pharmacy network adequacy of
Medicare Part D plans, and benefit coverage requirements under Medicare
Advantage and Medicaid. Commenters suggested that OCR should not
enforce a discrimination claim if the underlying design is accepted by
the plan's regulator and should defer enforcement action to existing
review processes where appropriate. Some commenters also suggested that
the Department should establish a safe harbor for health insurance
issuers to comply with section 1557 in cases where there are State law
interactions to avoid creating multiple or duplicative standards.
Response: OCR acknowledges commenters' concerns about harmonization
in the regulation and enforcement of benefit design requirements across
State and Federal laws. We note that covered entities offering health
insurance coverage and other health-related coverage, such
[[Page 37617]]
Medicaid or qualified health plans in the Exchanges, are subject to a
host of other laws and regulations, at both the State and Federal
level. OCR does not view a covered entity's compliance with other State
or Federal laws, which were adopted under different requirements and
for different purposes, to be determinative in all cases of a covered
entity's compliance with section 1557, unless otherwise specified in
this rule.\226\ OCR commits to coordinating with other Federal agencies
as appropriate to avoid inconsistency and duplication in enforcement
efforts and will consider issuing guidance in coordination with other
agencies, such as CMS, after publication of the rule. We will give
consideration to a covered entity's compliance with other Federal laws
when those requirements overlap with section 1557's requirements and
will work closely with covered entities when compliance with this final
rule requires additional action. That said, as the lead enforcement
agency for section 1557, OCR maintains sole authority to determine a
covered entity's compliance with this final rule.
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\226\ E.g., 45 CFR 92.203, which requires covered entities to
comply with certain accessibility requirements in the ADA.
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Comment: Commenters requested clarity on which covered entity is
liable for potentially discriminatory plan benefit designs when several
covered entities provide or administer elements of the benefit design.
Commenters requested that OCR state that all entities, including third
party administrators, benefits advisers, and consultants, that
participate in discriminatory plan design with respect to group or
individual insurance plans are covered entities under section 1557. A
commenter requested that benefits advisers or consultants working with
employers to design self-funded group health plans specifically should
be considered a covered entity presumptively where the employer, the
plan, or the third party administrator receives Federal financial
assistance. The commenter noted concern that such advisers and
consultants are a driving force behind discriminatory plan design and
should be put on notice that their conduct is subject to section 1557
in many circumstances. A commenter requested that OCR make clear that
any entity itself covered by section 1557 violates the statute by
outsourcing the implementation or design of discriminatory plans to
entities that might themselves not be covered by the statute.
Response: OCR clarifies that in situations where multiple covered
entities provide or administer elements of a discriminatory benefit
design, all of the entities may be found liable under section 1557. In
the discussion of the definition of ``Federal financial assistance'' in
Sec. 92.4, we explained that both the direct recipient and
subrecipient (or subcontractor) are responsible for complying with
applicable civil rights laws. We also note that covered entities are
responsible for the conduct of their subcontractors and cannot
outsource or contract away their civil rights obligations by entering
into contractual arrangements with subcontractors. The responsibility
of third party administrators is discussed later in this section. As
noted, this final rule does not apply to employment practices. See
Sec. 92.2(b).
Comment: Commenters expressed concern that the proposed regulation
may unintentionally limit covered entities' ability to develop
effective programs and initiatives to close care gaps and address
unique needs to reduce health disparities. Commenters explained that
they currently conduct individual outreach to members of a subgroup
through care management processes, invest in social determinants of
health interventions, tailor marketing to subgroups to address
particular health concerns, provide plans that restrict enrollment to
special needs individuals with specific chronic conditions, and develop
targeted quality programs and chronic care management programs to
reduce health disparities for their members. A commenter noted that
issuers take those actions to more efficiently provide care to
particularly vulnerable populations without an intent to discriminate.
Another commenter noted that if health plans are required to provide
services that address chronic care, social determinants of care, or
other similar programs ``equally'' to all enrollees rather than
``equitably'' target services to those in need based on health or
socioeconomic condition, plans will be limited in their ability to
provide appropriate services and scale and sustain these programs. To
address these concerns, commenters requested that OCR clarify in the
final rule that actions taken to reduce health disparities and those
designed to improve health for specific populations are not
discriminatory for purposes of section 1557. Commenters also
recommended that OCR consider an approach similar to language in the
Department's Group Health Insurance Market regulations prohibiting
prohibition on discrimination based on health status that explicitly
permits group health plans and health insurance issuers to treat
individuals with adverse health conditions more favorably. 45 CFR
146.121(g).\227\
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\227\ In this final rule, we cite to HHS regulations, but note
that the Departments of Labor and the Treasury have parallel
regulatory citations.
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Response: We appreciate commenters raising this concern and applaud
efforts to mitigate and address health disparities. Nothing in this
rule prohibits programs designed to improve health outcomes for
specific populations so long as the programs do not discriminate on the
basis of race, color, national origin, age, sex, or disability. For
example, programs could be developed using social determinants of
health or other metrics that serve to identify underrepresented
individuals that are not based on protected bases under section 1557.
To illustrate, a ``Special Needs Plan'' is a specialized Medicare
Advantage coordinated care plan that exclusively enrolls ``special
needs individuals,'' who are not limited to individuals with
disabilities, and do not violate section 1557.\228\ In addition,
covered entities are permitted and encouraged to develop programs that
address health disparities related to a person's age. Under the Age Act
and section 1557, age distinctions in programs that provide special
benefits to older adults or children are permitted. 45 CFR 91.17 (Age
Act); 92.101(b)(1) (section 1557, incorporating 45 CFR 91.17).
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\228\ See sections 1859(b)(6), 1859(f)(2)-(4) of the Social
Security Act (42 U.S.C. 1395w-28(b)(6), (f)(2)-(4)).
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Scope of Application to Health Insurance Coverage and Other Health-
Related Coverage (Including Excepted Benefits and STLDI)
In the 2022 NPRM, we sought comment on excepted benefits and short-
term, limited-duration health insurance (STLDI), and the Proposed
Rule's application to these products. Consistent with the definition of
``health program or activity'' under Sec. 92.4, we proposed that the
rule would apply to all the operations of any covered entity
principally engaged in the provision or administration of health
insurance coverage or other health-related coverage. 87 FR 47875-
76.\229\ As an example, we explained that an issuer participating in
the Exchange and thereby receiving Federal financial assistance would
be covered by the rule for its qualified health plans offered on the
Exchange, as well as for its health
[[Page 37618]]
plans offered outside the Exchange, including, for example, large group
market plans,\230\ grandfathered plans,\231\ grandmothered plans,\232\
excepted benefits,\233\ and STLDI,\234\ as well as for its operations
related to acting as a third party administrator for self-insured group
health plans. 87 FR 47876.
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\229\ However, per Sec. 92.2(b), this rule does not apply to
employers with regard to their employment practices, including the
provision of employee health benefits.
\230\ 42 U.S.C. 300gg-91(e)(3); 45 CFR 144.103.
\231\ 42 U.S.C. 18011; 45 CFR 147.140.
\232\ Grandmothered 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 U.S. Dep't of Health & Hum.
Servs., 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.
\233\ 42 U.S.C. 300gg-21(b), 300gg-63, and 300gg-91(c); 45 CFR
144.103, 146.145(b), and 148.220(b). The Departments of HHS, Labor,
and the Treasury share interpretive jurisdiction over the definition
of ``excepted benefits''. We cite to HHS regulations but note that
the Departments of Labor and the Treasury have parallel statutory
and regulatory citations.
\234\ Short-term limited duration insurance is a type of health
insurance coverage that is generally exempt from the provisions of
title XXVII of the PHS Act because it is specifically excluded from
the definition of ``individual health insurance coverage'' in the
PHS Act. See 42 U.S.C. 300gg-91(b)(5). Short-term limited duration
insurance is currently 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 defined by the
Departments of HHS, Labor, and the Treasury (Tri-Departments). The
Tri-Departments issued a Notice of Proposed Rulemaking on Short-
Term, Limited-Duration Insurance; Independent, Noncoordinated
Excepted Benefits Coverage; and Tax Treatment of Certain Accident
and Health Insurance that would revise the definition of ``Short-
Term Limited-Duration Insurance'' to limit the length of the initial
contract period to no more than three months and the maximum
coverage period to no more than four months, taking into account any
renewals or extensions. 88 FR 44596 (July 12, 2023). In this final
rule, we cite to HHS regulations, but note that the Departments of
Labor and the Treasury have parallel regulatory citations.
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The comments and our responses regarding the scope and application
to all operations of a covered health insurance issuer and to excepted
benefits and STLDI specifically are set forth below.
Comment: Several commenters, including those representing the
health insurance industry and some State insurance regulators, raised
concerns about how the Proposed Rule's application to all operations of
a recipient health insurance issuer would result in covering an
issuer's other operations and lines of business that do not receive
Federal financial assistance, including, for example, plans sold off
the Exchange, grandfathered plans, grandmothered plans, employer plans,
excepted benefits, STLDI, third party administrator activities and
pharmacy benefit manager activities. Commenters noted that these plans
are treated separately under the ACA and are not subject to some or all
of the ACA's health insurance market reforms. Commenters suggested that
plans that do not receive Federal financial assistance should not be
subject to section 1557. Comments about particular types of plans are
discussed in turn below.
Commenters argued the Proposed Rule's application was too broad and
went beyond Congressional intent and urged OCR to retain the 2020
Rule's approach that the rule cover a health insurance issuer's
operations only to the extent the operations directly receive Federal
financial assistance.
In addition, commenters argued that applying the rule to a covered
issuer's operations that do not receive Federal financial assistance
would create an unlevel playing field among health insurance issuers
that accept Federal funding and those that do not, placing those that
receive Federal funding at a competitive disadvantage. For example,
commenters stated that issuers that do not receive Federal financial
assistance may underwrite excepted benefits or STLDI by age or sex, or
exclude higher cost health care services, which may result in non-
covered entities offering lower-cost coverage to a pool of individuals
whose coverage is less costly, while the pool of individuals under a
covered entity's coverage could be costlier, leading to higher
premiums. Commenters also argued that covered entities would be subject
to increased compliance costs to which competitors are not subject. For
example, these commenters stated that compliance with the rule's
nondiscrimination notices would result in tremendous costs to which
non-covered entities are not subject. Some commenters argued that this
competitive disadvantage could discourage issuers from participating in
the Exchanges.
A few commenters that supported the proposed application to all an
issuer's operations also raised concerns that the rule would create an
unlevel playing field that would disadvantage plans that support
Federal programs like Medicare and Medicaid while giving an unfair
competitive advantage to competitors that are not required to comply
with nondiscrimination requirements. To level the playing field, these
commenters and others suggested that OCR work with other Federal
agencies and develop a tri-Department rule with the Departments of
Labor and the Treasury to subject all health plans to similar
nondiscrimination and accessibility requirements.
A number of commenters, including some members of Congress,
supported the broad application of the rule to an issuer's other
operations and argued the 2020 Rule's approach is contrary to
Congress's intent in passing the ACA to prohibit discrimination in
health care. Commenters argued that a private insurance company
receiving financial assistance from the Federal Government should not
be allowed to engage in discriminatory practices in its other lines of
business. Commenters observed that issuers offering plans that receive
Federal financial assistance, such as qualified health plans or
Medicare Advantage plans, often also offer plans that do not receive
Federal financial assistance. Noting that many of these other types of
plans are not currently subject to any or all nondiscrimination
requirements under the ACA's health insurance market reforms, these
commenters argued that the Proposed Rule's broad application will
increase protections from discriminatory practices for individuals
enrolled in those plans.
Response: OCR appreciates the concerns raised by some commenters
regarding the Proposed Rule's application to all operations of a
recipient health insurance issuer; however, these concerns do not
abrogate a recipient's obligation to comply with section 1557. Under
the definition of ``health program or activity'' at Sec. 92.4, a
recipient of Federal financial assistance that is principally engaged
in the provision or administration of health insurance coverage or
other health-related coverage is covered under this rule for all of its
operations. Section 1557 applies to ``any health program or activity,
any part of which is receiving Federal financial assistance,'' 42
U.S.C. 18116(a) (emphasis added). As we explain in detail under the
discussion of the definition of ``health program or activity'' in Sec.
92.4, it is reasonable to infer that Congress intended the term
``health program or activity'' to be interpreted broadly and to include
all of that entity's operations if the entity that receives Federal
funding is principally engaged in the provision or administration of
health insurance coverage or other health-related coverage.\235\
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\235\ See, e.g., Fain v. Crouch, 545 F. Supp. 3d 338, 342-43
(S.D.W. Va. 2021) (finding ```health program or activity' under
Section 1557 necessarily includes health insurance issuers'' and
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''), rehearing en banc granted, No. 22-1927 (4th Cir. Apr.
12, 2023) (oral argument held Sept. 21, 2023) (argued with Kadel v.
Folwell, No. 22-1721).
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[[Page 37619]]
In response to comments that this obligation might cause a
competitive disadvantage with entities that do not accept Federal
funds, this obligation is consistent with statutory text as set forth
by Congress, as discussed above. Further, the risk of competitive
disadvantage is low given that the majority of health insurance issuers
offer some type of product that receives Federal financial assistance,
such as Medicare Advantage plans, Medicare Part D prescription drug
plans, Medicaid managed care plans, and qualified health plans through
the Exchanges.\236\ In any event, by accepting the benefit of Federal
funds, a recipient is prohibited from discriminating in its health
programs and activities under section 1557, as discussed previously
under the definition of ``health program or activity.'' Any recipient
of Federal financial assistance from the Department is subject to this
same requirement and prohibited from discriminating in its health
programs and activities, including all of its operations when
principally engaged, as set forth in this final rule.
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\236\ U.S. Dep't of Health & Hum. Servs., Ctrs. for Medicare &
Medicaid Servs., Medical Loss Ratio Data and System Resources
(2022), https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.
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Section 1557 does not authorize OCR to require a health plan or
insurance issuer not otherwise subject to section 1557 to comply with
the statute. Whether the Department could issue a rule, under different
authority, with the Departments of Labor and the Treasury, to apply
similar nondiscrimination and accessibility standards to all health
plans or health insurance issuers, is outside the scope of this rule.
We further address comments about particular types of plans and
their coverage under this final rule in various comment responses
below.
Comment: Some commenters requested that grandfathered and
grandmothered plans should be exempt from the rule because they are not
subject to many of the ACA's provisions. These plans benefit consumers,
commenters stated, by allowing them to maintain affordable existing
coverage as long as it continues to meet their needs. Commenters argued
that applying section 1557 to these plans would be inconsistent with
the longstanding regulatory treatment of the plans. Further, commenters
argued that the costs of complying with section 1557, including but not
limited to notice and tagline requirements, could result in increased
costs for issuers, which would be passed on to consumers, and could
lead to a decision to discontinue plans.
Response: OCR understands commenters' concerns and acknowledges
that grandfathered and grandmothered plans are not subject to many of
the ACA's provisions. However, the statutory text of the grandfathered
health plan provision \237\ indicates that Congress did not intend to
exclude them from dection 1557. The statute sets forth the specific
provisions of the PHS Act that apply to grandfathered plans and then
provides that except for those provisions, ``this subtitle and subtitle
A (and the amendments made by such subtitles) shall not apply'' to
grandfathered plans. 42 U.S.C. 18011(a)(2). ``This subtitle'' refers to
subtitle C of title I of the ACA, while ``subtitle A'' refers to
subtitle A of title I of the ACA, both of which contain market reforms.
Section 1557 is in subtitle G of title I of the ACA and therefore is
not one of the subtitles that Congress specified should not apply to
grandfathered health plans.
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\237\ Grandfathered health plans were established by Congress in
title I of the ACA to permit the continuation of coverage for
certain plans in effect as of the date of enactment of the ACA
(March 23, 2010) in which individuals were enrolled at that time. 42
U.S.C. 18011; 45 CFR 147.140. Grandfathered health plans are
statutorily subject to only certain market reforms in the ACA, 42
U.S.C. 18011(a)(3)-(5), and thus are not subject to certain market
reforms related to nondiscrimination, such as fair health insurance
premiums and EHB. To maintain grandfathered status, plans cannot
make certain changes to the terms of the plan or coverage.
Specifically, certain changes to benefits, cost-sharing
requirements, and contribution rates will cause a plan or coverage
to relinquish its grandfather status.
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Grandmothered plans \238\ were not established in the ACA or the
PHS Act; they are not exempt from the ACA or the PHS Act by statute or
regulation. Rather, CMS specified that it will not take enforcement
actions against grandmothered plans that are out of out of compliance
with certain specified ACA market reforms under certain conditions (CMS
Non-Enforcement Policy).\239\ The CMS Non-Enforcement Policy has been
in place since 2013 \240\ and has provided relief from the same ACA
market reform provisions continuously since that time.\241\ Section
1557 has never been one of the provisions for which enforcement relief
was provided; therefore, grandmothered plans are not exempt from
section 1557.
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\238\ Grandmothered 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, including those related to
nondiscrimination, such as fair health insurance premiums, the
prohibition of preexisting condition exclusions or other
discrimination based on health status with respect to adults (except
with respect to group coverage), the prohibition of discrimination
based on health status (except with respect to group coverage), and
EHB.
\239\ See U.S. Dep't of Health & Hum. Servs., 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.
\240\ See Letter from Gary Cohen, Director, Ctr. for Consumer
Info. & Ins. Oversight, Ctrs. for Medicare & Medicaid Servs., to
Insurance Commissioners (Nov. 14, 2013), https://www.cms.gov/cciio/resources/letters/downloads/commissioner-letter-11-14-2013.pdf.
\241\ See U.S. Dep't of Health & Hum. Servs., 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.
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When offered by a recipient health insurance issuer, grandfathered
and grandmothered plans would be covered under the rule as part of the
issuer's operations when the issuer is principally engaged in the
business of providing or administering health insurance coverage or
other health-related coverage. If OCR were to receive a complaint about
a grandfathered plan or grandmothered plan, OCR would carefully
consider the facts and circumstances of the challenged action or
practice. As discussed throughout this section, the health insurance
issuer may provide a legitimate, nondiscriminatory reason for the
action or practice. Further, in cases of alleged disability
discrimination, covered entities may also prove that modifying a plan
to comply with section 1557 would result in a fundamental alteration to
their health program or activity.
Comment: A commenter requested clarification on how the rule would
apply to Medicare Employer Group Waiver Plan (EGWP) participants.
Response: EGWPs are types of Medicare Part C (Medicare Advantage)
plans \242\ or Medicare Part D prescription drug plans \243\ that
qualify for waivers of certain Medicare regulations because they are
offered exclusively to the employees, former employees, members or
former members of an employer, union or labor organization, or the
trustees of a fund established by one or more employers or labor
organizations (or combination thereof). Entities that receive funding
through the Department's Medicare Part C or Medicare Part D program are
subject to the rule as recipients of Federal financial assistance. This
includes entities providing Medicare
[[Page 37620]]
Advantage plans or Medicare Part D plans, including EGWPs, or qualified
retiree prescription drug plans (as defined at 42 CFR 423.882) (also
known as RDS plans). Because employers and other plan sponsors are not
subject to this rule with regard to their employment practices,
pursuant to Sec. 92.2(b), an employer or other plan sponsor would not
be liable for discrimination related to these plans under this rule.
This applies even if an employer directly contracts with CMS to offer a
Medicare Advantage or Part D plan as an EGWP and receives Federal
financial assistance for that EGWP.\244\ In circumstances where an
employer offers an ``800 series'' EGWP through a Medicare Advantage
organization or Part D plan sponsor,\245\ the health insurance issuer
or entity offering the EGWP would be subject to the rule for the EGWP
plan due to receipt of either Medicare Part C or Part D funding.
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\242\ 42 U.S.C. 1395w-27(i); 42 CFR 422.106.
\243\ 42 U.S.C. 1395w-132(b); 42 CFR 423.458.
\244\ CMS may contract directly with an employer, union or labor
organization, or the trustees of a fund established by one or more
employers or labor organizations (or combination thereof) for the
entity to offer a Medicare Advantage plan or Part D plan to its
employees, former employees, members or former members. 42 U.S.C.
1395w-28(i) and 1395w-132(b); 42 CFR 422.106(d) and 423.458(c).
\245\ In these situations, a Medicare Advantage organization or
a Part D plan sponsor contracts with CMS to offer the Medicare
health or drug plan and separately contracts with the employer,
union or labor organization, or trustee of a fund established by one
or more employers or labor organizations (or combination thereof)
for the Medicare Advantage organization or Part D plan sponsor to
offer an EGWP. For more information about direct contract and ``800
series'' EGWPs, see generally U.S. Dep't of Health & Hum. Servs.,
Ctrs. for Medicare & Medicaid Servs., Medicare Managed Care Manual,
Chapter 9--Employer/Union Sponsored Group Health Plans (2013),
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c09.pdf.
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Comment: One commenter requested clarification as to whether self-
funded non-Federal Governmental plans, such as municipal plans, that
opt out of certain Federal market reforms are covered under this rule
if they receive funds from the Department directly or indirectly.
Response: A self-funded non-Federal Governmental plan is a
governmental plan established or maintained by a non-Federal
Governmental agency, such as a State, county, school district, or
municipality, for its employees.\246\ As with any other type of group
health plan coverage, a non-Federal Governmental plan would be subject
to this rule if it directly or indirectly receives Federal financial
assistance from the Department. The non-Federal Governmental agency
sponsoring the employee health benefit plan would be excluded from
liability under this rule an employer or plan sponsor, as applicable,
pursuant to Sec. 92.2(b).
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\246\ 42 U.S.C. 300gg-91(d)(8)(A)-(C); 45 CFR 144.103. For more
information on self-funded, non-Federal Governmental plans, see U.S.
Dep't of Health & Hum. Servs., Ctrs. for Medicare & Medicaid Servs.,
Self-Funded, Non-Federal Governmental Plans, https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/nonfedgovplans.
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Comment: Commenters requested that the rule clarify when group
health plans are subject to the rule.
Response: A group health plan is subject to this rule if it is a
recipient (or subrecipient) of Federal financial assistance as set
forth under Sec. 92.2(a)(1). We address the rule's applicability to
group health plans in more detail in the discussion above under
Sec. Sec. 92.1 (Applicability) and 92.4 (definition of ``health
program or activity'').
Comment: Several commenters expressed concerns with the rule's
proposed application to excepted benefits as part of a covered health
insurance issuer's operations and urged OCR to exclude excepted
benefits from the rule. Commenters argued that the rule's coverage of
excepted benefits is inconsistent with Congressional intent and likely
subject to legal challenge. These commenters explained that excepted
benefits are statutorily defined benefits that Congress has long
recognized as distinct from traditional health insurance coverage by
excluding them from health insurance and group health plan coverage
mandates under the PHS Act, ERISA, and the Internal Revenue Code, as
long as they meet certain requirements.\247\ Commenters argued that the
ACA retained this exclusion and that Congress therefore intended
excepted benefits to be excluded from the ACA. To further demonstrate
Congressional intent to exclude excepted benefits, commenters stated
that since Congress first recognized excepted benefits in 1996 as part
of HIPAA by incorporating their provisions into the PHS Act, ERISA, and
the Internal Revenue Code, Congress has had several opportunities to
redefine excepted benefits or to impose new requirements on them in
subsequent laws, including the ACA, but it has not chosen to do
so.\248\
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\247\ Title XXVII of the PHS Act; part 7 of ERISA; chapter 100
of the Internal Revenue Code.
\248\ For example, the Mental Health Parity Act of 1996;
Newborns' and Mothers' Health Protection Act of 1996 (NMHPA);
Genetic Information Nondiscrimination Act of 2008 (GINA); Paul
Wellstone and Pete Domenici Mental Health Parity and Equity
Additional Act of 2008 (MHPAEA); Michelle's Law (2008); ACA (2010);
and No Surprises Act (2020).
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While acknowledging that section 1557 does not explicitly exclude
excepted benefits, commenters asserted that OCR cannot use its
regulatory authority to impose new requirements that are inconsistent
with the carefully crafted statutory provisions governing excepted
benefits where Congress has clearly chosen not to do so. As support,
commenters cited to Central United Life v. Burwell, 827 F.3d 70 (D.C.
Cir. 2016). Commenters stated the court in Central United struck down a
Department rule that revised the requirements related to fixed
indemnity excepted benefit insurance in the individual market as an
unconstitutional exercise of regulatory authority because the ACA
maintained the HIPAA excepted benefit exemption for these benefits and
the law did not authorize the Department's proposed requirement.
Central United, commenters argued, illustrates that nothing in the ACA
changes the excepted benefits governing statutes and demonstrates that
agencies must adhere to the boundaries set forth in Federal statute.
Commenters stated that the ACA is entirely focused on comprehensive
medical coverage, while excepted benefits are not intended to serve as
such coverage. They maintained that excepted benefits are not used to
finance the delivery of health care services but are meant to provide
benefits for a wide variety of costs associated with accidents or
illnesses not covered by comprehensive medical insurance, or to defray
costs that are not fully covered by comprehensive medical coverage. For
example, commenters stated that some of these products, such as dental
and vision plans and Medicare supplemental insurance (Medigap), can
cover additional benefits not included in comprehensive medical plans.
Commenters stated that noncoordinated excepted benefits, such as fixed
indemnity excepted benefits and specified disease excepted benefits
coverage, must pay benefits regardless of whether the medical event
triggering benefits is covered under another plan. Commenters stated
that while comprehensive medical insurance coverage is regulated
through HIPAA or the ACA, excepted benefits are subject to separate
long-standing and extensive State regulatory regimes whereby Congress
and State policymakers have consistently maintained excepted benefits
are not meant to be a type of comprehensive health insurance that pays
for medical benefits, and therefore, commenters argue, should not be
within the purview of the ACA, including section 1557.
Commenters further expressed concerns that applying the rule to
excepted benefits could severely disrupt the market for these benefits
and may drive competitors out of the market,
[[Page 37621]]
ultimately increasing health care costs and premiums and reducing
product choice for consumers and employers, and thereby reducing access
to care. Commenters also asserted that applying the rule to excepted
benefits could result in increased costs that are passed onto consumers
as increased premiums, which could result in individuals dropping
coverage due to lack of affordability and thereby result in reducing
access to care, particularly in dental plans where consumers are highly
price sensitive when selecting coverage.
Conversely, many other commenters supported applying the rule to
excepted benefits as part of an issuer's operations. Commenters noted
that excepted benefits are under-regulated and not otherwise subject to
nondiscrimination requirements. Commenters argued this would provide
comprehensive nondiscrimination protections for individuals enrolled in
excepted benefits, particularly individuals with disabilities who face
barriers to accessing care.
Response: OCR appreciates the breadth of comments received and the
concerns raised. Excepted benefits are statutorily defined benefits
that are exempt from the Federal consumer protection and market reforms
applicable to comprehensive coverage under title XXVII of the PHS Act,
part 7 of ERISA, and Chapter 100 of the Internal Revenue Code
(hereinafter the Federal consumer protections and market reform
requirements applicable to comprehensive coverage). Some excepted
benefits are exempt from the Federal consumer protection and market
reform requirements applicable to comprehensive coverage in all
circumstances, such as coverage only for accident, workers'
compensation or similar coverage, disability income coverage, and
coverage for on-site medical clinics. 42 U.S.C. 300gg-21(b), 300gg-
63(a), and 300gg-91(c)(1).
Other types of coverage, known as limited excepted benefits, are
exempt from the Federal consumer protection and market reform
requirements applicable to comprehensive coverage when the benefits are
offered under a separate policy, certificate or contract of insurance,
or are otherwise not an integral part of the plan. 42 U.S.C. 300gg-
21(c)(1), 300gg-63(b), and 300gg-91(c)(2). Examples of limited excepted
benefits include certain limited scope vision insurance and limited
scope dental insurance (though stand-alone dental plans sold through
the Exchange are subject to certain qualified health plan
requirements),\249\ and long term care insurance.
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\249\ See, e.g., 45 CFR 155.1065 and 156.150.
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Another type of coverage, known as independent, noncoordinated
excepted benefits, are exempt from the Federal consumer protection and
market reform requirements applicable to comprehensive coverage when
certain conditions are met. 42 U.S.C. 300gg-21(c)(2), 300gg-63(b), and
300gg-91(c)(3). This category of excepted benefits includes coverage
only for a specified disease or illness (such as cancer-only policies)
and hospital indemnity or other fixed indemnity insurance.
The final type of excepted benefit coverage is supplemental
excepted benefits. Benefits are supplemental excepted benefits only if
they are provided under a separate policy, certificate, or contract of
insurance and are Medicare supplemental health insurance (also known as
``Medigap''), coverage supplemental to the coverage provided under 10
U.S.C. chapter 55 (also known as TRICARE supplemental programs), or
similar supplemental coverage provided to coverage under a group health
plan. 42 U.S.C. 300gg-21(c)(3), 300gg-63(b), and 300gg-91(c)(4).
Excepted benefits offer more limited coverage than, and are
generally not intended to be an alternative to or replacement for,
comprehensive coverage. These products are not subject to the Federal
consumer protections and market reform requirements applicable to
comprehensive coverage when applicable criteria are met. As we stated
in the 2016 Rule, 81 FR 31431, and the 2022 NPRM, 87 FR 47875, and
restate here, the fact that excepted benefits are exempt from the
Federal consumer protections and market reform requirements applicable
to comprehensive coverage, including the ACA's consumer protections and
market reforms, and are not intended to serve as comprehensive coverage
does not justify their exclusion from section 1557.\250\ In addition,
section 1557 does not limit its protections only to health programs and
activities that are themselves subject to other provisions of the ACA
or that are comprehensive coverage, but also applies to all operations
of any covered entity that is principally engaged, as defined under the
term ``health program or activity'' in Sec. 92.4. Further, section
1557 is an independent provision, which Congress did not codify in the
PHS Act or co-locate in the ACA with the ACA's market reforms. Further,
section 1557 uses the broad term ``health program or activity,'' in
contrast to elsewhere in the ACA where Congress specifically made
distinctions between various types of insurance. If Congress had
intended to limit section 1557's reach to only certain types of
insurance in the PHS Act or to carve out excepted benefits from the
scope of section 1557, it could have done so.
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\250\ We further note that none of the statutory provisions that
establish the exemption for these products from the PHS Act Federal
consumer protections and requirements applicable to comprehensive
coverage extend beyond the requirements in title XXVII of the PHS
Act. See 42 U.S.C. 300gg-21(b)-(c), 300gg-63, and 300gg-91(c).
---------------------------------------------------------------------------
OCR is mindful of comments raised about potential market disruption
and reduced health care options for the public. However, as we
discussed previously in the definition of ``health program or
activity'' under Sec. 92.4, commenters did not provide sufficient
evidence to support this contention. Further, we note that when OCR has
determined that a particular plan is discriminatory under this final
rule, a covered entity may provide a legitimate, nondiscriminatory
reason for the plan's benefit design. This could include evidence that
compliance with Sec. 92.207 would result in making the plan
unaffordable to the extent the covered entity could no longer offer the
plan. When such a reason is proffered, OCR will carefully consider the
evidence presented by the covered entity in making our determination as
to whether the reason is legitimate and not pretext for discrimination.
In the case of alleged disability discrimination, covered entities may
also prove that modifying a plan to comply with section 1557 would
result in a fundamental alteration to their health program or activity.
For these reasons, we are not excluding excepted benefits from
requirements established in this final rule. If a recipient health
insurance issuer is principally engaged in the provision or
administration of health insurance coverage or other health-related
coverage, all of its operations are covered, including its provision of
excepted benefits. Further, we note that a principally engaged issuer
would not be covered under this rule for its excepted benefits
subsidiary if the issuer can prove that the subsidiary is legally
separate from its federally funded activities.\251\
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\251\ For more information on how OCR will analyze such claims,
see discussion of subsidiary liability under the definition of
``health program or activity'' in Sec. 92.4 and under the
Application to Third Party Administrators in this section.
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Commenters' reliance on Central United to argue that this rule
exceeds OCR's regulatory authority by imposing new requirements that
are inconsistent
[[Page 37622]]
with statutory provisions regarding excepted benefits is misplaced. In
Central United, the court invalidated the requirement at 45 CFR
148.220(b)(4)(i) that an individual must attest to having minimum
essential coverage prior to purchasing fixed indemnity excepted
benefits coverage in the individual market. The court held that
imposing that requirement went beyond what Congress required under the
PHS Act. 827 F.3d at 74. The PHS Act statutes at issue in Central
United contain statutory language specifically addressing excepted
benefits, while section 1557 does not expressly mention or address
excepted benefits. Further, Congress could have but did not extend the
exemption under the PHS Act for these products to section 1557.\252\
OCR therefore maintains that this rule's interpretation and application
to all operations of a recipient health insurance issuer when
principally engaged, including an issuer's excepted benefits, is the
best reading of the section 1557 statutory language, which applies to
``any health program or activity, any part of which is receiving
Federal financial assistance.'' 42 U.S.C. 18116(a) (emphasis added).
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\252\ See 42 U.S.C. 300gg-21(b)-(c) and 300gg-63. See also the
conforming amendments in section 1563(a) of the ACA.
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Comment: A few commenters raised concerns with the sufficiency of
the Proposed Rule's discussion on excepted benefits. These commenters
asserted the Proposed Rule did not adequately explain why subjecting
excepted benefits to the rule is necessary or appropriate. Commenters
stated that the regulatory text does not address excepted benefits and
that the preamble discussion does not explain how the rule would apply
to excepted benefits. Thus, according to commenters, there was
insufficient notice for public comment, which they assert would likely
subject the final rule to legal challenge as violative of the
Administrative Procedure Act. These commenters argued OCR should issue
a new Proposed Rule with comment period that explains how OCR intends
to address excepted benefits and provides additional clarity on how the
rule will apply to excepted benefits, taking into account the specific
nature and legal structure of such products that Congress made
statutorily distinct from major medical products. Commenters also
objected to the Proposed Rule's investigative approach to evaluate
claims of discrimination on a case-by-case basis, with one commenter
arguing the case-by-case approach indicated a ``regulation-by-audit
scheme.''
Response: We disagree that the Proposed Rule failed to adequately
provide notice and opportunity to comment on OCR's reasoning regarding
the applicability of section 1557 to all operations of a recipient
health insurance issuer that is principally engaged in the provision or
administration of health insurance coverage or other health-related
coverage. We fully discussed OCR's legal authority and reasoning
regarding this scope of coverage in the Proposed Rule's discussion of
the definition of ``health program or activity'' under Sec. 92.4. 87
FR 47844-45. We also disagree that the Proposed Rule did not provide
notice to the public of the terms or substance of how OCR intends to
address excepted benefits for purposes of applying section 1557. In the
preamble to the Proposed Rule, we clearly stated that all operations of
a covered issuer principally engaged would include its other plans,
explicitly mentioning excepted benefits. 87 FR 47875-76. Further, in
the Proposed Rule, 87 FR 47875, we described the subject and the issues
involved in how OCR will analyze claims of discriminatory benefit
design by specifically stating that we acknowledged the unique nature
of these products as being exempt from the Federal consumer protections
and market reform requirements applicable to comprehensive coverage,
and discussed how OCR proposes to investigate such plans by considering
the nature, scope, and contours of the specific plan at issue and
evaluating on a case-by-case basis an alleged discriminatory design
feature in light of the entity's stated coverage parameters.\253\ We
also reiterated that covered entities have the opportunity to
articulate a legitimate, nondiscriminatory basis for their challenged
action or practice. As discussed throughout this section and in the
Proposed Rule, OCR's analysis for investigating a potentially
discriminatory benefit design--as well as for all OCR investigations--
is necessarily a fact-specific, case-by-case analysis. This is true for
allegations related to benefit design features in all plans, including
major medical coverage as well as excepted benefits.
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\253\ 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).
---------------------------------------------------------------------------
Comment: Some commenters raised concerns specific to Medicare
supplemental health insurance (known as ``Medigap''), which is an
excepted benefit, and requested that the rule not apply to such plans.
Commenters argued that applying section 1557 to Medigap plans would
be inconsistent with Congress's intent and the interlocking Federal-
State regulatory framework set forth by Congress. A commenter noted
that when Congress wants to alter this regulatory scheme, it speaks
clearly,\254\ and because Congress made no such specific reference to
Medigap when enacting section 1557, Congress intended Medigap to be
beyond the scope of section 1557. Commenters discussed that Medigap is
highly standardized coverage comprehensively regulated under both
Federal and State law over which issuers have little discretion with
respect to plan benefit design.\255\ Commenters explained that Federal
law prescribes ten different types of Medigap benefit packages, with
each offering a different set of standardized benefits.\256\ Commenters
noted that Congress established a Federal-State regulatory framework
that prescribes the benefits, eligibility, and rating methodologies
permissible for Medigap plans, with States establishing State-specific
requirements for Medigap policies sold in their State. For example, a
commenter noted that State laws may regulate Medigap plans in several
ways, such as premium rating based on age, sex/gender, or medical
underwriting, with some states requiring sex/gender rating; Medigap
eligibility criteria based on an individual's age, disability, or end-
stage renal disease, with some States specifying that Medigap plans are
not available to such individuals; and State-specific standardized
Medigap plans over which issuers have no control with respect to
benefit design, communications, or other factors.
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\254\ For example, the commenter noted that Congress revised the
Medigap statute when it wanted to expressly apply section 104 of the
Genetic Information Nondiscrimination Act to Medigap. Public Law
100-360, 102 Stat. 683, sec. 221 (1988) (codified in 42 U.S.C.
1395ss).
\255\ See 42 U.S.C. 1395ss, 42 CFR 403.200 through 403.258; see
also Nat'l Ass'n of Ins. Comm'rs, NAIC Model Regulation to Implement
the NAIC Medicare Supplement Insurance Minimum Standards Model Act,
MO-651-1 (2022), https://content.naic.org/sites/default/files/model-law-651.pdf.
\256\ See 42 U.S.C. 1395ss. See also U.S. Dep't of Health & Hum.
Servs., Ctrs. for Medicare & Medicaid Servs., Choosing a Medigap
Policy: A Guide to Health Insurance for People with Medicare, 11
(2023), https://www.medicare.gov/publications/02110-medigap-guide-health-insurance.pdf.
---------------------------------------------------------------------------
Commenters stated that Medigap is commonly underwritten after an
initial open enrollment period to prevent adverse selection, and that
Medigap
[[Page 37623]]
issuers are generally limited to competing along two dimensions: price
and customer service.\257\ Commenters argued that subjecting Medigap to
section 1557 could result in adverse selection that could force covered
issuers to leave the Medigap market, resulting in reduced consumer
choice, higher Medigap premiums, and lower quality of service for
seniors.
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\257\ U.S. Dep't of Health & Hum. Servs., Ctrs. for Medicare &
Medicaid Servs., Medigap (Medicare Supplement Health Insurance),
https://www.cms.gov/Medicare/Health-Plans/Medigap (stating that
``the only difference between medigap policies sold by different
insurance companies is the cost.'').
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If the final rule does not exclude Medigap from section 1557,
commenters requested at minimum that the rule specify that covered
issuers are not responsible for possible discriminatory benefit
designs, decisions, or actions that are a result of complying with a
Federal or State requirement, including State-approved commercial
underwriting practices.
Response: OCR appreciates the concerns raised by commenters about
Medigap, which is a statutorily defined excepted benefit.\258\ Medigap
is a type of private supplemental health insurance coverage designed to
cover cost-sharing gaps in original Medicare, such as deductibles,
coinsurance, and copayments.\259\ Medigap is regulated by both Federal
and State law. 42 U.S.C. 1395ss. Congress standardized Medigap plans to
establish standard plan designs.\260\ While the plan benefits are
standardized, the premiums and availability of the plans may vary by
issuer depending on Federal and State law requirements. Medigap plans
are statutorily prohibited from medical underwriting based on health
status or imposing preexisting condition exclusions under certain
circumstances, including during a six-month Medigap open enrollment
period that begins when an individual turns 65 and enrolls in Medicare
Part B and other specific times when guaranteed issue rights are
available, 42 U.S.C. 1395ss(s), after which they are generally not
prohibited from such practices under Federal law. States may enact
their own State-specific requirements on Medigap, including whether the
plans are guaranteed issue and whether the premiums may be rated based
on age, health status, sex, or other factors.\261\ In addition, while
there generally is no Federal Medigap open enrollment period during
which time Medigap plans must be sold to individuals with disabilities
under the age of 65, some States may require it.\262\
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\258\ Referred to as ``Medicare supplemental health insurance''
under 42 U.S.C. 300gg-91(c)(4); 45 CFR 144.103, 146.145(b)(5), and
148.220(b)(5).
\259\ Cong. Rsch. Serv., R47552, Medigap: Background and
Statistics, 2 (2023), https://sgp.fas.org/crs/misc/R47552.pdf.
\260\ Omnibus Budget Reconciliation Act of 1990, H.R. 5835, Pub.
L. 101-508, pt. 5, Nov. 5, 1990, 104 Stat. 1388, https://www.congress.gov/bill/101st-congress/house-bill/5835. See also Cong.
Rsch. Serv., R47552, Medigap: Background and Statistics, 5-7 (2023),
https://sgp.fas.org/crs/misc/R47552.pdf.
\261\ See, e.g., Cristina Boccuti et al., Kaiser Family Found.,
Medigap Enrollment and Consumer Protections Vary Across States, pp.
8-13 (2018), https://files.kff.org/attachment/Issue-Brief-Medigap-Enrollment-and-Consumer-Protections-Vary-Across-States.
\262\ See 42 U.S.C. 1395ss(s)(2)(A). See also Cong. Rsch. Serv.,
R47552, Medigap: Background and Statistics, 3 (2023), https://sgp.fas.org/crs/misc/R47552.pdf.
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Like other excepted benefits, Medigap is not designed to serve as
comprehensive coverage and does not receive Federal financial
assistance. As an excepted benefit, Medigap plans would be subject to
the rule in the same fashion as other excepted benefits: if a Medigap
plan is offered by a recipient health insurance issuer that is
principally engaged in the provision or administration of health
insurance coverage or other health-related coverage as specified under
the definition of ``health program or activity'' in Sec. 92.4, the
Medigap plan would be subject to the rule as part of the issuer's
operations.
That said, we acknowledge commenters' concerns about State law
requirements that might result in benefit design features that could
violate section 1557. When investigating a discriminatory design
feature in a Medigap plan, OCR will evaluate the covered entity's
legitimate, nondiscriminatory reason for the challenged feature. If the
reason is based on a Federal or State law requirement, OCR will take
this information into account when evaluating the context of the
challenged design feature and will work with the covered entity to
achieve compliance to help ensure that issuers do not leave the Medigap
market or lower quality of products for consumers; however, section
1557 would preempt a State law Medigap requirement--or any other
excepted benefit requirement--that compelled conduct prohibited by
section 1557 as applied to a recipient health insurance issuer subject
to section 1557.
Comment: Many commenters supported the Proposed Rule's application
to STLDI as part of a principally engaged covered entity's operations.
Commenters argued that the proposed broad application is crucial to
protect against discrimination in these products.
Commenters stated that STLDI plans are marketed, often misleadingly
and fraudulently, as an alternative to comprehensive coverage, but have
significant gaps that lead to high out-of-pocket costs and little
financial protection for consumers.\263\ Commenters stated that STLDI
plans are under-regulated and use a lax regulatory environment to
market and sell products that can harm individuals, especially those
with complex health needs. For example, a commenter stated that a
person with cancer would pay anywhere from $23,000 to $100,000 in out-
of-pocket expenses during the first six months following diagnosis
under an STLDI plan.\264\
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\263\ See, e.g., Sabrina Corlette et al., Urban Inst., The
Marketing of Short-Term Health Plans: An Assessment of Industry
Practices and State Regulatory Responses (2019), https://www.urban.org/sites/default/files/publication/99708/moni_stldi_final_0.pdf.
\264\ See, e.g., Gabriela Dieguez & Dane Hansen, Milliman, The
Impact of Short-Term Limited-Duration Policy Expansion on Patients
and the ACA Individual Market, p. 13 (2020), https://www.lls.org/sites/default/files/National/USA/Pdf/STLD-Impact-Report-Final-Public.pdf.
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Commenters discussed that STLDI plans charge higher prices based on
an applicant's age, sex, or disability and exclude or severely limit
coverage for benefits related to preexisting conditions, prescription
medications, mental health, and preventive services for women,
contraception, and maternity care, all of which adversely impact
individuals with disabilities, women, and individuals who are or who
may become pregnant.\265\ Commenters suggested that the plans appear to
be designed to discourage enrolling women of child-bearing age and that
one study revealed that all plans reviewed discriminated against women
through various practices, including gender rating and coverage
exclusions.\266\ Commenters stated that including
[[Page 37624]]
coverage under section 1557 for these plans is particularly important
for individuals with disabilities, including those with HIV, hepatitis,
and mental health and substance use disorder disabilities who are
harmed by discriminatory practices, such as including more frequent
application of prior authorization and fail-first protocols and denials
of medically necessary services.
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\265\ See, e.g., H.R. Comm. on Energy & Com., 116th Cong.,
Shortchanged: How the Trump Administration's Expansion of Junk
Short-Term Health Insurance Plans is Putting Americans at Risk
(2020), https://drive.google.com/file/d/1uiL3Bi9XV0mYnxpyaIMeg_Q-BJaURXX3/view; Dania Palanker & Emily Curran, Commonwealth Fund,
Limitations of Short-Term Health Plans Persist Despite Predictions
That They'd Evolve (2020), https://www.commonwealthfund.org/blog/2020/limitations-short-term-health-plans-persist-despite-predictions-theyd-evolve; JoAnn Volk et al., Commonwealth Fund,
Trump Administration Promotes Coverage That Fails to Adequately
Cover Women's Key Health Care Needs (2020), https://www.commonwealthfund.org/blog/2020/trump-administration-promotes-coverage-that-fails-to-cover-womens-key-health-care-needs.
\266\ H.R. Comm. on Energy & Com., 116th Cong., Shortchanged:
How the Trump Administration's Expansion of Junk Short-Term Health
Insurance Plans is Putting Americans at Risk, 61, 74 (2020), https://drive.google.com/file/d/1uiL3Bi9XV0mYnxpyaIMeg_Q-BJaURXX3/view.
---------------------------------------------------------------------------
Because STLDI plans are not subject to traditional oversight of
their provider networks, commenters stated that the plans may be
designed in a way that limits care for LGBTQI+ people, individuals with
disabilities, older individuals, individuals with LEP, or people of
color.\267\ In addition, commenters observed that STLDI plans
retroactively cancel coverage and are not guaranteed renewable, leaving
people with serious health conditions without coverage and often unable
to enroll if the denial occurred outside of an ACA open enrollment
period.\268\
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\267\ See, e.g., H.R. Comm. on Energy & Com., 116th Cong.,
Shortchanged: How the Trump Administration's Expansion of Junk
Short-Term Health Insurance Plans is Putting Americans at Risk
(2020), https://drive.google.com/file/d/1uiL3Bi9XV0mYnxpyaIMeg_Q-BJaURXX3/view.
\268\ See, e.g., Gabriela Dieguez & Dane Hansen, Milliman, The
Impact of Short-Term Limited-Duration Policy Expansion on Patients
and the ACA Individual Market, p. 11 (2020), https://www.lls.org/sites/default/files/National/USA/Pdf/STLD-Impact-Report-Final-Public.pdf.
---------------------------------------------------------------------------
One insurance industry commenter raised detailed concerns about
applying the rule to STDLI in its discussion opposing the rule's
application to excepted benefits. The commenter argued that similar to
arguments above regarding excepted benefits, Congress excluded these
products from most of the ACA's requirements and that applying the rule
to these products would create a competitive disadvantage for covered
entities that must comply with section 1557 as compared to non-
recipient competitors that can offer lower-cost coverage due to the
ability to vary premium rates on the basis of factors otherwise
prohibited under section 1557 or exclude higher cost benefits. The
commenter also argued recipients would be subject to greater costs due
to compliance with section 1557's procedural requirements.
Response: OCR appreciates commenters' support and shares the
concerns raised by commenters about the misleading and deceptive
practices of some issuers of STLDI plans. STLDI is excluded from the
definition of ``individual health insurance coverage'' under the PHS
Act.\269\ As a result, it is generally exempt from the Federal consumer
protections and market reform requirements applicable to comprehensive
coverage offered in the individual market, such as the prohibition on
discrimination based on health status, 42 U.S.C. 300gg-4, the
prohibition of preexisting condition exclusions, 42 U.S.C. 300gg-3, and
the prohibition on lifetime and annual dollar limits on EHB, 42 U.S.C
300gg-11, among others. These plans were traditionally not designed to
serve as comprehensive coverage and were intended to fill temporary
coverage gaps when an individual was transitioning between
comprehensive coverages. See 81 FR 38020, 38032 (June 10, 2016).\270\
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\269\ 42 U.S.C. 300gg-91(b)(5) defines ``individual health
insurance coverage'' to mean ``health insurance coverage offered to
individuals in the individual market, but does not include short-
term limited duration insurance.'' (Emphasis added.)
\270\ See also, U.S. Dep't of Health & Hum. Servs., Short-Term
Limited Duration Insurance: Independent, Noncoordinated Excepted
Benefits Coverage; Level-Funded Plan Arrangements; and Tax Treatment
of Certain Accident and Health Insurance, Proposed Rule, 88 FR 44596
(July 12, 2023) (proposing to narrow the definition of ``short-term
limited duration insurance'' to mean health insurance coverage that
has an expiration date that is ``no more than 3 months after the
original effective date of the policy, certificate, or contract of
insurance, and taking into account any renewals or extensions, has a
duration no longer than 4 months in total''.)
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OCR acknowledges the commenter's concerns about competitive
disadvantage and compliance costs. However, as discussed previously,
the risk of competitive disadvantage is low given that the majority of
health insurance issuers offer some type of product that receives
Federal financial assistance, and by accepting the benefit of Federal
funds, a recipient is prohibited from discriminating in its health
programs and activities under section 1557. For the same reasons set
forth above explaining why this rule applies to a principally engaged
recipient issuer's excepted benefits, STLDI would be covered under this
final rule as part of a recipient issuer's operations if the issuer is
principally engaged as set forth in the definition of ``health program
or activity'' at Sec. 92.4. That Congress excluded STLDI from the PHS
Act definition of individual health insurance coverage does not exclude
such coverage from section 1557. Congress could have but did not extend
the exemption for these products to section 1557. section 1557 applies
to ``health programs or activities'' and contains no exceptions for
certain types of plans or coverage, nor is it limited to plans or
coverage that are subject to other provisions in the ACA. OCR therefore
maintains that this rule's interpretation and application to all
operations of a recipient health insurance issuer when principally
engaged, including an issuer's products, is the best reading of the
section 1557 statutory language, which applies to ``any health program
or activity, any part of which is receiving Federal financial
assistance.'' 42 U.S.C. 18116(a) (emphasis added).
Application to Third Party Administrators
In the Proposed Rule, we discussed that 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 insurance coverage or other health-related
coverage as set forth in the definition of ``health program or
activity'' under Sec. 92.4. 87 FR 47876-77. We stated 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.
When investigating complaints relating to third party
administrators that are appropriately covered under section 1557, we
stated that OCR will determine whether responsibility for the decision
or alleged discriminatory action lies with the plan sponsor or with the
covered third party administrator. Where the alleged discrimination
relates to the administration of the plan by a covered third party
administrator, we stated that 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. We also
stated that OCR will pursue claims against the covered 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. Where the alleged
discrimination relates to the benefit design of self-insured group
health plan coverage that did not originate with the third party
administrator, but rather with the plan sponsor, OCR will refer the
complaint to the Equal Employment Opportunity Commission (EEOC) or DOJ
for potential investigation. We discussed that we would refer
complaints related to the Federal Employees Health Benefits (FEHB)
Program, the Federal Employees Dental and Vision Insurance Program
(FEDVIP), or the Federal Long Term
[[Page 37625]]
Care Insurance Program (FLTCIP) to the Office of Personnel Management
(OPM).
The comments and our responses regarding coverage of third party
administrator activities are set forth below.
Comment: Several commenters supported the rule's application to
third party administrators as part of the operations of a principally
engaged recipient health insurance issuer. Commenters stated that
issuers often serve as third party administrators and the rule's
application to an issuer's third party administrator activities will
help achieve health equity, improve health outcomes, and ensure that
all individuals can access health care without unnecessary barriers.
Commenters stated that third party administrators play an outsized role
in administering and designing health coverage for millions of people
enrolled in self-funded employer group health plan coverage,\271\ which
may contain discriminatory provisions prohibited by section 1557.\272\
Commenters discussed how third party administrators do more than simply
process claims. These commenters stated that, similar to issuers, third
party administrators make significant decisions about critical health
plan features and often design benefits, formularies, payment
structures, and networks; conduct prior authorization; and establish
and evaluate other clinical coverage criteria. One commenter stated
that third party administrators rely on their own clinical criteria,
which may result in discriminatory denials of coverage despite the plan
providing coverage generally. For example, the commenter discussed that
where a self-funded plan might provide coverage for gender-affirming
care, the third party administrator might rely on its own clinical
criteria to categorically exclude coverage for certain types of gender-
affirming care.
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\271\ Commenters noted that 64 percent of workers in the United
States receive health coverage through self-insured employer plans.
Gary Claxton et al., Kaiser Family Found., Employer Health Benefits
2021 Annual Survey, p. 9 (2021), https://files.kff.org/attachment/Report-Employer-Health-Benefits-2021-Annual-Survey.pdf.
\272\ See, e.g., Anna Kirkland et al., Transition Coverage and
Clarity in Self-Insured Corporate Health Insurance Benefit Plans, 6
Transgender Health 4, 214 (2021), https://www.liebertpub.com/doi/full/10.1089/trgh.2020.0067 (showing that employer plans had three
times as many categorical exclusions for gender-affirming health
care).
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Other commenters opposed the rule covering third party
administrators. These commenters argued the rule should exclude third
party administrators from the scope of the final rule and that section
1557's application should not extend beyond the legal entity that
provides or offers the ``health program or activity.'' Several
commenters argued that the rule's coverage of third party
administrators would create an unlevel playing field and result in a
competitive disadvantage for health insurance issuers that accept
Federal financial assistance. For example, commenters argued the
administrative costs of complying with section 1557, such as the
nondiscrimination notice requirements, would place covered third party
administrators at a competitive disadvantage with non-covered third
party administrators that are not subject to the same requirements.
Commenters asserted that third party administrators generally do not
receive Federal financial assistance and argued that applying section
1557 to third party administrators would result in subjecting all their
clients to section 1557's requirements when neither the client nor the
third party administrator receives Federal financial assistance.
Commenters argued this would create a disincentive for clients to
engage a third party administrator that is subject to section 1557 and
so would create an unlevel playing field between third party
administrators covered by section 1557 and those that are not.
Commenters further suggested this could result in entities deciding not
to participate in federally funded or conducted programs, such as the
Exchanges.
One commenter asserted OCR did not explain the need for this
proposed change from the 2020 Rule, which does not cover an issuer's
third party administrator activities, and that the uncertainty of how
the rule will apply to covered third party administrators would likely
result in higher third party administrator charges to employers, which
would be passed through to enrollees.
Response: We appreciate the diversity of comments received on our
proposal to apply section 1557 to third party administrators when
certain criteria are met. The final rule applies to all the operations
of a recipient principally engaged in the provision or administration
of health insurance coverage or other health-related coverage,
including its third party administrator activities, as discussed in
detail previously under the definition of ``health program or
activity'' under Sec. 92.4. This position is also supported by a
decision of the District Court for the Western District of Washington,
which held that third party administrators operated by health insurance
issuers are subject to section 1557 even if the third party
administrators do not receive Federal financial assistance.\273\ In
addition, a third party administrator could be covered under the rule
if it is a subrecipient of Federal financial assistance. We also note
that where a third party administrator is not covered under section
1557, a covered entity that contracts with a third party administrator,
such as a health insurance issuer or group health plan, may be liable
for the third party administrator's actions as a subcontractor. Please
see the earlier discussion on subrecipients and contractors in the
sections on Application, Sec. 92.2, and the definition of ``Federal
financial assistance,'' Sec. 92.4.
---------------------------------------------------------------------------
\273\ See C. P. by & through Pritchard v. Blue Cross Blue Shield
of Ill., No. 3:20-CV-06145-RJB, 2022 WL 17788148, at *8 (W.D. Wash.
Dec. 19, 2022).
---------------------------------------------------------------------------
We acknowledge commenters' concerns that this may result in a
competitive disadvantage for health insurance issuers that accept
Federal financial assistance. This argument, however, is not unique to
health insurance issuers or their third party administrator activities.
Any covered entity that accepts Federal funding from the Department
knowingly agrees to comply with section 1557 and other civil rights
laws that apply to recipients of Federal financial assistance.
Comment: Some commenters were opposed to the rule holding a third
party administrator liable for plan benefit designs even if the
discriminatory terms originated with the third party administrator.
Commenters stated this approach was inconsistent with the 2016 Rule's
approach that a third party administrator was liable only where the
third party administrator was ``responsible for the decision or action
. . . as the decision-making entity.'' 81 FR 31432. These commenters
requested that OCR clarify that a third party administrator will be
held responsible for actions only when it is the entity that controls
whether or not the action must be taken. Commenters argued that third
party administrators should not be liable for plan benefit designs
simply because a third party administrator suggested or helped develop
the benefit design ultimately chosen by the group health plan because
the third party administrator is not the decision-making entity that
adopted the benefit design. Accordingly, commenters argued that third
party administrators should not be held responsible for administering
benefits based on benefit design decisions made solely by a plan
sponsor and urged OCR to clarify that the rule will not apply to third
party
[[Page 37626]]
administrators in cases where a plan sponsor adopts a potentially
discriminatory plan design that the third party administrator played no
role in selecting.
Commenters also noted that, under ERISA, third party administrators
generally must administer self-insured plans according to the plans'
terms. 29 U.S.C. 1104(a)(1)(D). These commenters asserted that a third
party administrator should not be liable for the benefit design of a
plan, including utilization management techniques, when it is
administering the plan consistent with the plan terms as adopted by the
group health plan or plan sponsor. Otherwise, commenters argued, the
rule would effectively hold a third party administrator responsible for
decisions made by another entity, namely, the plan's named fiduciary or
plan administrator. Commenters further stated that ERISA does not
require the third party administrator to be responsible for plan terms,
but does require the plan sponsor to have a ``named fiduciary'' that
has ultimate control over the plan's operation.\274\ A commenter argued
it would be unreasonable for OCR to take the position that a third
party administrator is legally obligated under section 1557 to violate
its obligation under ERISA to honor its contract with the plan sponsor
and honor the plan's terms.
---------------------------------------------------------------------------
\274\ See, e.g., Dep't of Labor, Meeting Your Fiduciary
Responsibilities (2021), https://www.dol.gov/node/63375.
---------------------------------------------------------------------------
Commenters also argued that covering third party administrators is
contrary to Congressional intent. Commenters stated that under ERISA,
Congress made the group health plan responsible for the benefits it
chooses to provide, and that OCR should not shift that responsibility
to third party administrators through section 1557. These commenters
argued that had Congress intended for third party administrators to be
subject to section 1557, it would have said so clearly.
In contrast, several commenters expressed support for the rule that
would make a covered third party administrator liable when the
discriminatory plan feature originated with the third party
administrator. These commenters asserted that third party
administrators cannot insulate themselves from liability by arguing
that ERISA requires a group health plan to be administered according to
its terms (including by a third party administrator contracted by a
plan sponsor). ERISA, commenters noted, does not exempt group health
plans or their service providers (including third party administrators)
from complying with other Federal laws, like section 1557.\275\ These
commenters, citing to case law,\276\ argued that third party
administrators should be held liable under section 1557 for
discriminatory plan administration and when discriminatory plan terms
originate with the third party administrator, even when the plan
sponsor subsequently adopts the plan designed by the third party
administrator and maintains control over its terms. Commenters noted
that many large health insurance issuers design and market self-funded
plans to plan sponsors and contract to serve as third party
administrators.\277\ Commenters noted that third party administrators
are largely responsible for designing plans except for those offered by
the most sophisticated employers. Commenters stated that issuers
administer the self-funded plans using the same coverage policies that
they use in their fully insured plans, and therefore the discriminatory
terms in self-funded plans are often directly traceable to and
redressable by third party administrators.
---------------------------------------------------------------------------
\275\ See 29 U.S.C. 1144(d) (``Nothing in this subchapter shall
be construed to alter, amend, modify, invalidate, impair, or
supersede any law of the United States . . . .'').
\276\ Tovar v. Essentia Health, 857 F.3d 771, 778 (8th Cir.
2017).
\277\ Blue Cross Blue Shield of N.D., Self-Funding, Alternative
Financial Arrangements for Group Benefit Plans, p. 1 (2019), https://www.bcbsnd.com/content/dam/bcbsnd/documents/brochures/employers/29300143_BND-Self-Funding-Brochure.pdf (``Groups with 26 or more
employees enrolled have a choice of several standard design plan
options available. There is additional flexibility for custom
designed benefit plans for groups with more than 50 employees
enrolled.''); UnitedHealthcare, UMR, https://www.uhc.com/employer/employer-resources/umr (stating UMR, UnitedHealthcare's third party
administrator, ``serve[s] over 5 million members with custom plan
designs, cost-containment solutions and innovative services'').
---------------------------------------------------------------------------
Some commenters suggested that third party administrators should be
liable for administering a plan with discriminatory benefit design
features even when the plan design did not originate with the third
party administrator. Commenters argued that third party administrators
that agree to administer discriminatory plans play a role in
discriminating against protected individuals and should not be given
immunity when administering plans with discriminatory designs.
Response: OCR carefully considered the variety of views expressed
by commenters relating to the liability of a third party administrator
covered under this rule. We agree with commenters that a third party
administrator should not be held responsible for discriminatory plan
design features over which the third party administrator exercised no
control.
We disagree with commenters that believe a covered third party
administrator should not be liable for discriminatory benefit design
features that originated with the third party administrator simply
because the plan sponsor is ultimately the entity responsible under
ERISA for adopting the plan and maintaining control over its terms. Our
interpretation is consistent with case law, which has held that a third
party administrator may be liable for discriminatory plan terms that
originated with the third party administrator, notwithstanding the fact
that the plan sponsor subsequently adopted the plan and maintained
control over the terms.\278\ Further, as commenters noted, health
insurance issuers operating as third party administrators often design
the plans that they offer to self-insured group health plans and offer
standard plan design options, often to small and midsize employers
while only offering flexibility in the plan design to larger
employers.\279\
---------------------------------------------------------------------------
\278\ See, e.g. Tovar v. Essentia Health, 857 F.3d 771, 778 (8th
Cir. 2017) (concluding that enrollee in a self-insured employer-
sponsored plan could establish Article III standing for a claim of
discrimination under section 1557 to sue a third party administrator
where ``the plan and its allegedly discriminatory terms originated
with [the third party administrator]--not with [the employer],'' and
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''); C. P. by & through Pritchard v. Blue Cross Blue
Shield of Ill., No. 3:20-CV-06145-RJB, 2022 WL 17788148, at *7, *9
(W.D. Wash. Dec. 19, 2022) (holding that ``third party
administrators can be liable under Section 1557 based on
discriminatory terms in a self-funded plan even if the third party
administrator provided the plan document `notwithstanding the fact
that the [plan sponsor] subsequently adopted the plan and maintained
control over its terms''' (quoting Tovar, 857 F.3d at 778)); 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 where the harm suffered
``was proximately caused by [the third party administrator's]
designing and providing to [the self-insured plan] the
discriminatory provisions in the plan'').
\279\ See, e.g., Blue Cross Blue Shield of N.D., Self-Funding,
Alternative Financial Arrangements for Group Benefit Plans, p. 1
(2019), https://www.bcbsnd.com/content/dam/bcbsnd/documents/brochures/employers/29300143_BND-Self-Funding-Brochure.pdf (``Groups
with 26 or more employees enrolled have a choice of several standard
design plan options available. There is additional flexibility for
custom designed benefit plans for groups with more than 50 employees
enrolled.'').
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We recognize that ERISA requires group health plans to be
administered consistent with the terms governing the plan, as long as
the terms are consistent with the provisions of the same
[[Page 37627]]
subchapter in ERISA.\280\ ERISA then provides in the same subchapter
that it is not to be construed to impair or supersede other Federal
laws, including regulations issued under such laws.\281\ This rationale
finds support in the cases that have held that ERISA's requirement that
a plan's terms must be administered as written must not be construed to
invalidate or impair section 1557.\282\
---------------------------------------------------------------------------
\280\ 29 U.S.C. 1104(a)(1)(D) (``[A] fiduciary shall discharge
his duties with respect to a plan solely in the interest of the
participants and beneficiaries and . . . in accordance with the
documents and instruments governing the plan insofar as such
documents and instruments are consistent with the provisions of this
subchapter and subchapter III.'' (emphasis added)).
\281\ 29 U.S.C. 1144(d) (``Nothing in this subchapter shall be
construed to alter, amend, modify, invalidate, impair, or supersede
any law of the United States (except as provided in sections 1031
and 1137(b) of this title) or any rule or regulation issued under
any such law.'').
\282\ See, e.g., C. P. by & through Pritchard v. Blue Cross Blue
Shield of Ill., No. 3:20-CV-06145-RJB, 2022 WL 17788148, at *8, 10
(W.D. Wash. Dec. 19, 2022) (holding that ERISA's requirement at 29
U.S.C. 1104(a)(1)(D) to administer a plan's terms as written ``is
subservient to Section 1557, outlawing discrimination, which is
dominant''); Tovar v. Essentia Health, 342 F. Supp. 3d 947, 954 (D.
Minn. 2018) (``The Court will not construe ERISA to impair Section
1557. Nothing in Section 1557, explicitly or implicitly, suggests
that TPAs are exempt from the statute's nondiscrimination
requirements.'').
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For these reasons, we affirm our general approach as discussed in
the Proposed Rule at 87 FR 47876-77. When OCR investigates a
potentially discriminatory action or plan design related to a self-
insured group health plan coverage administered by a covered entity
acting as a third party administrator, OCR will take into account the
party responsible for the alleged discriminatory conduct. Recognizing
that third party administrators might not be responsible for the
benefit designs of the self-insured group health plan coverage that
they administer, OCR does not intend to enforce this rule against a
third party administrator for a plan design that it did not design and
over which it has no control. Where the discriminatory terms of the
plan originated with the covered third party administrator rather than
with the plan sponsor, the third party administrator could be liable
for the discriminatory design feature under section 1557.
Accordingly, when analyzing a claim against a covered third party
administrator, OCR will determine whether responsibility for the
decision or alleged discriminatory action lies with the third party
administrator, group health plan, or the plan sponsor. Where the
alleged discrimination relates to the administration of the plan by a
covered third party administrator, OCR will process the complaint
against the covered third party administrator because it is the entity
responsible for the decision or other action being challenged. For
example, if a covered third party administrator applies a plan's
neutral, nondiscriminatory utilization management guidelines in a
discriminatory way against an enrollee, OCR will proceed against the
covered third party administrator as the entity responsible for the
decision. In addition, OCR will pursue claims against a covered 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.
For instance, if a covered third party administrator develops standard
plan designs that it offers to employers, the covered third party
administrator is liable for any discriminatory design feature in the
plans because the plans originated with the third party administrator.
Where the alleged discrimination relates to the benefit design of self-
insured group health plan coverage that did not originate with the
covered third party administrator, but rather with the plan sponsor or
the group health plan, and where the third party administrator played
no role in the development of the plan's benefit design, OCR will refer
the complaint to the EEOC or DOJ for potential investigation.
As discussed in the Proposed Rule at 87 FR 47877, 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.
Accordingly, OCR will transfer matters to the EEOC or DOJ where OCR
lacks jurisdiction over an employer responsible for the benefit design
of employer-sponsored group health plan coverage. OCR will refer to OPM
complaints alleging discrimination in the FEHB Program (including the
Postal Service Health Benefits Program), FEDVIP, and FLTCIP. This Rule
does not determine how or whether any other agency will investigate or
enforce any matter referred or transferred by OCR.
As part of OCR's analysis, we will also engage in a fact-specific
inquiry to evaluate whether a third party administrator is
appropriately covered under section 1557 in circumstances where the
third party administrator is legally separate from the issuer that
receives Federal financial assistance, as discussed in more detail
below.
Comment: Commenters requested that OCR provide additional clarity
on the circumstances under which OCR would hold a third party
administrator liable under the rule. Commenters stated that plan
sponsors and third party administrators may place blame on each other
for the discriminatory features. Another commenter said that a self-
insured plan sponsor could direct a third party administrator on the
goals or parameters of the design it seeks or refer the third party
administrator to other plan designs and request that the third party
administrator develop a plan design in accordance with those
parameters. The commenter argued that in these cases, where the third
party administrator is not the decision-making entity that ultimately
controls and determines whether to implement the design or feature, it
should not be liable under section 1557 for that design or feature.
Response: If a third party administrator is a covered entity under
section 1557, it is responsible for ensuring that its actions do not
discriminate on the basis of race, color, national origin, sex, age, or
disability. Where a covered third party administrator plays a role in
designing benefits for self-insured group health plan coverage, it must
not do so in a manner that results in discrimination on a prohibited
basis. This is so even if the plan sponsor requests that the covered
third party administrator develop a certain plan design that includes a
discriminatory feature. For example, if a plan sponsor requested that a
covered third party administrator develop a plan design that excluded
all enrollees of a certain race, there would be no question that a
third party administrator could not design such a plan without
violating section 1557. This is true for any other discriminatory
design feature that would violate section 1557. In these cases, while
the plan sponsor may be the entity requesting the particular design
feature for a group health plan, the covered third party administrator
would still be liable as the entity that designed such a plan,
notwithstanding the plan sponsor's request.
Comment: Several commenters requested that OCR provide clarity on
the rule's application to pharmacy benefit managers. Many commenters
argued that pharmacy benefit managers, similar to third party
administrators, make significant decisions about critical health plan
features and should be liable when they are responsible for
discriminatory formulary benefit designs. Commenters noted that plan
sponsors often defer to the expertise of pharmacy benefit managers.
Commenters opposed to the rule's application to third party
administrators argued that pharmacy benefit managers similarly should
not be liable under the
[[Page 37628]]
rule when a pharmacy benefit manager was not responsible for designing
the plan benefits that were adopted by the plan sponsor, similar to
their arguments above against holding third party administrators liable
under the rule.
Response: We discuss the rule's applicability to pharmacy benefit
managers in the discussion under Sec. 92.4 regarding the definition of
``health program or activity.'' Pharmacy benefit managers are health
programs or activities and would be covered under the rule if they
receive Federal financial assistance. A pharmacy benefit manager that
does not directly receive Federal financial assistance would also be
covered under the rule if it is part of the operations of a recipient
that is principally engaged in the provision or administration of
health-related services, health-related insurance coverage, or other
health-related coverage, as set forth under the definition of ``health
program or activity'' at Sec. 92.4.\283\
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\283\ See, e.g., Doe One v. CVS Pharmacy, Inc., No. 18-cv-01031-
EMC, slip op. at 12-23 (N.D. Cal., Aug. 5, 2022) (relying on section
1557, the 2016 Rule, and the incorporated civil rights statutes to
conclude that the complaint plausibly alleged that CVS Pharmacy,
Inc. is principally engaged in the business of health care and all
of its operations are covered by section 1557, including its
pharmacy benefit managers Caremark, L.L.C. and Caremark PCS Health,
L.L.C.).
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If a pharmacy benefit manager is subject to section 1557 as part of
the operations of a principally engaged recipient, we agree with
commenters that the pharmacy benefit manager's liability under the rule
would be similar to that of a covered third party administrator. Both
entities contract with other parties, such as issuers or sponsors of
self-insured group health plan coverage, to administer health benefits
to plan enrollees. They may design plan benefits, formularies, payment
structures, networks, and conduct utilization management. Therefore, if
OCR receives a complaint about a covered pharmacy benefit manager, OCR
will evaluate the liability of the pharmacy benefit manager consistent
with the analysis set forth above for third party administrators. That
is, OCR will determine whether responsibility for the challenged action
lies with the covered pharmacy benefit manager or the plan sponsor.
Comment: One commenter requested that OCR clarify that
administrative actions such as developing documents or preparing policy
booklets for clients, alone, would not constitute third party
administrator liability for discriminatory plan design features.
Response: We affirm that such administrative actions would not
violate this rule to the extent the covered third party administrator
is merely relaying information to enrollees consistent with the
underlying plan terms that the third party administrator played no role
in developing.
Comment: Some commenters requested that the rule clarify that an
entity covered by section 1557 cannot outsource the implementation or
design of discriminatory plans to entities that are not covered by the
rule. Another commenter requested that OCR clarify that any third-party
company may be liable under section 1557 when discriminatory plan terms
originate with, or are managed by, the third-party company. For
example, the commenter stated that third-party specialty benefits
programs may promote or manage discriminatory specialty medication
programs.
Response: A covered entity that outsources the implementation or
benefit design of discriminatory plans remains liable under this rule
for any discriminatory plan terms. Under the discussion of the
definition of ``Federal financial assistance'' in Sec. 92.4, we
clarify that covered entities are responsible for the conduct of their
subcontractors and cannot outsource or contract away their civil rights
obligations by entering into contractual arrangements with
subcontractors.
A third-party company that develops or manages discriminatory plans
on behalf of a covered entity would only be liable under section 1557
to the extent the third-party company is a recipient or subrecipient of
Federal financial assistance from the Department, including if the
third party is part of a principally engaged recipient's operations.
Comment: Commenters requested that OCR clarify when liability under
section 1557 extends across affiliated companies. Some commenters
expressed concern that third party administrators and pharmacy benefit
managers would automatically be deemed to be covered entities under the
rule solely because they are related to an entity that received Federal
financial assistance. These commenters requested that the final rule
provide the same clarification that was in the 2016 Rule to clarify
that a third party administrator (or pharmacy benefit manager \284\) is
unlikely to be covered under the rule where they are ``a legal entity
that is truly independent of an issuer's other, federally funded,
activities.'' 81 FR 31433.
---------------------------------------------------------------------------
\284\ The 2016 Rule did not address pharmacy benefit managers.
---------------------------------------------------------------------------
Other commenters expressed concern that third party administrators
and pharmacy benefit managers could use complex corporate structures to
distinguish separate lines of business to evade compliance with section
1557.\285\ These commenters requested that OCR provide greater clarity
on when liability under section 1557 extends across affiliated
companies.
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\285\ Cf., Doe One v. CVS Pharmacy, Inc., No. 18-cv-01031-EMC,
slip op. at 15 (N.D. Cal., Aug. 5, 2022) (``To ignore the overall
interrelationship among the entities which, in the case at bar,
design and implement the allegedly discriminatory program and permit
the CVS interrelated entities to escape responsibility would exalt
form over substance and impair the effectiveness of the anti-
discrimination provision of the ACA.'').
---------------------------------------------------------------------------
Response: As discussed in the 2016 Rule, 81 FR 31433, OCR will
conduct a case-by-case analysis to determine whether a third party
administrator or pharmacy benefit manager is appropriately subject to
section 1557 as part of the operations of a recipient covered entity in
situations where the third party administrator or pharmacy benefit
manager is legally separate from an issuer or other covered entity that
receives Federal financial assistance. This fact-specific analysis will
rely on principles developed in longstanding civil rights case law,
such as the degree of interrelatedness between or among entities,
including the degree of common ownership and control between or among
entities.\286\ OCR will also examine whether the purpose of the legal
separation was to avoid liability or avoid the application of civil
rights law requirements--that is, whether it is intended to allow the
entity to continue to administer discriminatory health insurance
coverage or other health-related coverage.\287\ As indicated in the
2016 Rule, a third party administrator or pharmacy benefit manager is
unlikely to be covered by this final rule where it is a legal entity
that is truly independent
[[Page 37629]]
of an issuer's other, federally funded activities. We also address
subsidiary liability under the discussion of Sec. 92.4's definition of
``health program or activity.''
---------------------------------------------------------------------------
\286\ See, e.g., Papa v. Katy Indus., Inc., 166 F.3d 937, 939
(7th Cir. 1999), cert. denied, 528 U.S. 1019 (1999) (ADA, ADEA);
Arrowsmith v. Shelbourne, Inc., 69 F.3d 1235, 1240-42 (2d Cir. 1995)
(title VII); Valesky v. Aquinas Acad., 2011 U.S. Dist. LEXIS 103791,
No. 09-800 (W.D. Pa. Sept. 14, 2011) (title IX); Russo v Diocese of
Greenberg, 2010 U.S. Dist. LEXIS 96338, No. 09-1169 (W.D. Pa. Sept.
15, 2010) (title IX, section 504); Margeson v. Springfield Terminal
Railway Co., 1993 U.S. Dist. LEXIS 12243, No. CIV.A. 91-11475-Z (D.
Mass. Aug. 24, 1993) (section 504); See also Doe One v. CVS
Pharmacy, Inc., No. 18-cv-01031-EMC, slip op. at 12-23 (N.D. Cal.,
Aug. 5, 2022) (relying on section 1557, the 2016 Rule, and the
incorporated civil rights statutes to conclude that the complaint
plausibly alleged that CVS Pharmacy, Inc. is principally engaged in
the business of health care and all of its operations are covered by
section 1557, including its pharmacy benefit managers Caremark,
L.L.C. and Caremark PCS Health, L.L.C.)
\287\ Papa v. Katy Indus., Inc., 166 F.3d 937, 941 (7th Cir.
1999), cert. denied, 528 U.S. 1019 (1999) (ADA, ADEA).
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Comment: One commenter urged OCR to consider whether stop-loss
coverage sold by a covered third party administrator to an employer
results in discrimination on the basis of disability prohibited under
section 1557. The commenter stated that stop-loss coverage uses
techniques that target group members with high medical needs. The
commenter asserted this could result in stop-loss coverage penalizing
employers when a covered individual needs intensive treatment for a
disabling condition.
Response: Stop-loss insurance provides coverage for the benefit of
the employers, plan sponsors, or group health plans to cover financial
liability for such entities to provide protection against catastrophic
or unpredictable losses, and does not provide coverage for individuals.
Stop-loss insurance that does not discriminate against individuals on
the grounds protected under section 1557 does not implicate this final
rule.
Comment: A few commenters expressed concern that the rule's
application to covered third party administrators does not account for
situations where the third party administrator is administering plans
for religious employers. Commenters argued the rule could impose a
burden on an employer's religious beliefs. Another commenter further
argued that it could cause the employer to be exposed to liability for
a claim of employment discrimination. The commenter explained that
Sec. 92.207 prohibits covered entities, such as a covered third party
administrator, from providing a health-coverage related product that
aligns with the beliefs and practices of religious employers. The
commenter argued this results in a burden on the employer's religion
because such religious employers cannot obtain a health coverage-
related product that is illegal for covered entities to provide. If
such an employer were to obtain a group health plan that was consistent
with its faith, the commenter argued that the employer is at risk of
liability due to OCR's position that it will transfer complaints
alleging discrimination by an employer to the EEOC, which will review
the employer's plan to determine if it is discriminatory under title
VII of the Civil Rights Act.
Response: As discussed throughout this section, a health insurance
issuer or third party administrator subject to section 1557 is
prohibited from discriminating on the basis of race, color, national
origin, sex, age, or disability in its provision or administration of
health insurance coverage or other health-related coverage, and is also
able to seek assurance of a religious exemption consistent with Sec.
92.302(b). As specified in Sec. 92.2(b), section 1557 does not apply
to an employer or a plan sponsor with regard to its employment
practices, including the provision of employee health benefits. A
religious employer is able to obtain health insurance coverage or
administration of its self-funded group health plan coverage from any
entity not subject to section 1557, which would fall outside of the
application of this rule.
Network Adequacy
The comments and our responses regarding network adequacy are set
forth below.
Comment: Commenters appreciated OCR's attention to network adequacy
and its acknowledgement that certain provider networks may constitute
discriminatory benefit design under section 1557. Commenters stated
that discriminatory provider networks profoundly affect the
accessibility and quality of care for vulnerable populations. One
commenter expressed concern that OCR has limited interest in complaints
about access to care stemming from provider networks because the
preamble in the Proposed Rule emphasized that health plans have
discretion over benefit design and did not explicitly mention provider
networks. A commenter recommended that OCR amend the proposed Sec.
92.207(b)(2) to expressly reference provider networks as a type of
design feature that falls within the scope of prohibited discriminatory
activities.
Response: OCR acknowledges the importance of network adequacy in
ensuring nondiscriminatory access to health care while also recognizing
covered entities' autonomy in developing their provider networks as
part of their benefit design packages, consistent with existing State
and Federal network adequacy and other laws, including section
1557.\288\ OCR will accept complaints related to provider networks and
will investigate allegations of discrimination on a case-by-case basis.
OCR declines to amend Sec. 92.207(b)(2) because we believe the
regulatory text is clear as written and does not require further
clarification. As previously discussed, the term ``benefit design''
encompasses an array of features, including provider networks, and OCR
intends to interpret it broadly.
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\288\ Network plans offer medical care through a defined set of
providers under contract with the issuer. See 42 U.S.C. 300gg-
91(d)(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'').
---------------------------------------------------------------------------
Comment: Commenters urged OCR to include examples of discriminatory
network design while articulating several practices that they believed
to be violations of section 1557. Some network design practices
commenters characterized as discriminatory included low reimbursement
rates that lead to lower provider participation, arbitrary limits to
in-network providers, limiting the participation of safety-net
providers, insufficient providers with accessible medical equipment,
narrow pharmacy networks, and performance requirements related to cost
or other outcome and quality measures. Commenters argued that all of
these practices prevent access and may be used by covered entities to
dissuade enrollees with high health needs from enrolling in plans.
Response: OCR appreciates commenters providing examples of how
network plan designs might have discriminatory impacts on vulnerable
populations. While we agree that certain network plan designs and
practices, such as excluding all or most providers that specialize in
treating certain conditions, may be discriminatory under section 1557,
we will not establish minimum network adequacy standards in this
rulemaking. As discussed in the Proposed Rule, 87 FR 47877, covered
entities employing network plan designs may be subject to network
adequacy standards governed by State and Federal law. For example, CMS
regulations establish network adequacy requirements for qualified
health plans, Medicare Advantage plans, and Medicare Part D
prescription drug plans, and require states to develop and enforce
network adequacy standards for their contracted Medicaid managed care
plans. See 87 FR 47877. Many of these regulations establish specific
requirements that must be satisfied, such as inclusion of certain types
of providers and time and distance standards. Recognizing that network
adequacy is regulated by other Departmental regulations, as we noted in
the 2016 Rule, and again note here, it is outside the scope of section
1557 to establish uniform or minimum network adequacy standards.
Comment: Commenters asserted that discriminatory network design
practices lead to excessive, and often insurmountable, administrative
burdens
[[Page 37630]]
for enrollees. Commenters also stated that provider network appeals
processes can be opaque, arbitrary, and ultimately a tool to deny
access to necessary care that meet the definition of a disability under
the ADA. Commenters expressed concern over the increase in ``phantom
networks,'' plans that list providers as in-network when they are not
actually accepting patients, particularly for mental health providers.
For example, commenters cited a recent study that showed that 60
percent of the mental health providers in the Oregon Medicaid managed
care network were not actually accepting patients.\289\ Commenters
expressed frustration in discovering that certain in-network providers
are unable or unwilling to address multiple co-occurring disabilities
or general medical care for people with disabilities.
---------------------------------------------------------------------------
\289\ Jane M. Zhu et al., Phantom Networks: Discrepancies
Between Reported and Realized Mental Health Care Access in Oregon
Medicaid, 41 Health Affairs 7, 1016 (2022), https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2022.00052.
---------------------------------------------------------------------------
Response: Plan designs that subject individuals protected by
section 1557 to excessive administrative burdens to access coverage
benefits that other enrollees do not have to navigate to access
coverage may be discriminatory under section 1557. Section 92.207(b)
prohibits covered entities from discrimination ``in providing or
administering'' (emphasis added) health insurance coverage or other
health-related coverage.
Comment: Commenters requested strict monitoring and enforcement of
provider network compliance with section 1557. A commenter suggested
that OCR include scrutiny of provider networks via regular compliance
reviews in addition to investigating complaints. To determine whether a
certain network design is discriminatory, a commenter urged OCR to
consider access measures such as medication adherence, uptake of
innovative therapies, and complaints and appeals regarding delayed or
denied access to specialists and drugs. A commenter requested that OCR
provide greater scrutiny to the impact of provider network
consolidation, especially those involving religiously affiliated
institutions, in creating discriminatory impacts on health care
recipients.
Other commenters stated that OCR should not establish network
adequacy standards, as they believe that discrimination through network
adequacy is sufficiently addressed by other State and Federal agencies
as well as the National Association of Insurance Commissioners,
National Committee for Quality Assurance, and URAC (formerly
Utilization Review Accreditation Commission). Commenters noted that as
network requirements increase, providers and facilities demand
increased reimbursement rates, additional contracts for other member or
system facilities, and specific network tier placement. Commenters
asked OCR to consider limiting provider contracting practices such as
``all-or-nothing'' contracting and anti-tiering clauses. They noted
that such practices harm consumers by increasing provider leverage and
driving up health care costs.
Response: While we will not establish minimum network adequacy
standards in this rulemaking, we emphasize that to ensure compliance
with section 1557, covered entities must develop their networks in a
nondiscriminatory manner. When determining whether an entity has
violated this section, OCR will conduct a fact-intensive investigation
to determine whether the challenged network excludes individuals from
participation in or denies them the benefits of the plan, or otherwise
discriminates against them on the basis of race, color, national
origin, sex, age, or disability. This analysis will include evaluating
whether a covered entity utilized, in a nondiscriminatory manner, a
neutral rule or principle when deciding to adopt its provider network.
As noted in the Proposed Rule, OCR is cognizant that a variety of
factors may affect a covered entity's provider network design.\290\ If
OCR determines that a network design is discriminatory, covered
entities will be expected to provide a neutral, nondiscriminatory
reason for the network design that is not a pretext for discrimination.
---------------------------------------------------------------------------
\290\ Such factors include ``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.'' 87 FR 47877. We note that the
importance of geographic limitations may be reduced due to the
industry growth in virtual care and ease of medical travel, where
clinically appropriate.
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Concerns around provider consolidation are out of the scope of this
regulation; however, OCR acknowledges that as providers consolidate,
there may be increased or novel concerns around discriminatory provider
network design and impact to access to care for protected classes.
Medical Diagnostic Equipment
In the Proposed Rule, 87 FR 47836, OCR noted that individuals with
mobility disabilities experience challenges accessing preventative,
primary, and specialty care due to inaccessible medical diagnostic
equipment (MDE). OCR sought comment on the extent to which a lack of
accessible MDE within a provider network limits or denies access to
care for individuals with disabilities. OCR also requested comment on
whether it should incorporate the U.S. Access Board's Medical
Diagnostic Equipment Standards (MDE Standards) as enforceable standards
and whether a lack of accessible MDE constitutes discriminatory benefit
design or network inadequacy.
Comment: OCR received many comments urging OCR to adopt the MDE
Standards, created pursuant to section 510 of the Rehabilitation Act,
in the final rule. These commenters stated that inaccessible MDE leads
to poor health outcomes for people with disabilities, mainly because
inaccessible MDE results in individuals with disabilities receiving
less preventative care, including mammograms and cervical screenings,
compared to their counterparts without disabilities.\291\ One commenter
also noted that this lack of preventative care, and ensuing poor health
outcomes, could also place people with disabilities at unnecessary risk
for institutionalization. Finally, these commenters urged OCR to state
that the denial of services to individuals with disabilities due to
inaccessible MDE is discrimination under other Federal disability
rights laws, including section 504 and the ADA.
---------------------------------------------------------------------------
\291\ See Nat'l Council on Disability, Enforceable Accessible
Medical Equipment Standards: A Necessary Means to Address the Health
Care Needs of People with Mobility Disabilities (2021), https://www.ncd.gov/assets/uploads/reports/ncd_medical_equipment_report_508.pdf.
---------------------------------------------------------------------------
One commenter recommended that OCR require covered entities to
ensure that within 30 days of the publication of the final rule, all
newly purchased or replaced MDE comply with the MDE Standards. The
commenter also recommended that OCR require all covered entities that
use MDE to ensure that within two (2) years of the publication of this
rule, all of their MDE meets the MDE Standards. A different commenter
recommended that OCR use a similar approach to that required by the
2010 ADA Standards for Accessible Design, 75 FR 56236 (Sep. 15, 2010),
where accessible MDE would be purchased to replace older equipment as
needed.
Response: OCR appreciates the numerous comments requesting that the
final rule require covered entities to comply with the MDE Standards.
OCR agrees that when individuals with disabilities are denied
appropriate preventative health care due to the
[[Page 37631]]
inaccessibility of MDE, they are placed at increased risk of poor
health outcomes and potentially institutionalization. As noted, section
504, the ADA, and section 1557 all prohibit covered entities from
discriminating against people with disabilities by denying them
appropriate health care services. Requiring covered entities to comply
with the MDE Standards would be one method to ensure that people with
certain disabilities receive appropriate health care services, while
allowing for greater patient autonomy.
On September 14, 2023, OCR issued an NPRM proposing updates to the
Department's section 504 regulations.\292\ OCR proposed specific
accessibility standards, scoping requirements, and time periods for
compliance for MDE used by recipients of Federal financial assistance
in that NPRM.\293\ Accordingly, while OCR recognizes the importance of
ensuring that all people, regardless of disability status, receive
effective preventative care, we will not address the MDE Standards in
the regulatory text of this rulemaking.
---------------------------------------------------------------------------
\292\ 88 FR 63392 (Sept. 14, 2023).
\293\ 88 FR 63392, 63511 (Sept. 14, 2023) (proposed subpart J).
---------------------------------------------------------------------------
Comment: Many commenters noted that while the MDE Standards were
published in 2017, many providers, including recipients of Federal
financial assistance, have failed to abide by the standards and acquire
accessible MDE. As evidence, some commenters point to the data
collected by the State of California concerning the prevalence of
accessible MDE among providers, which they state indicates that the
majority of California providers do not have accessible MDE.\294\ These
commenters note that until a Federal regulation creates specific
requirements, accessible MDE will not be used by the majority of
providers. Finally, commenters noted that even if providers acquire
accessible MDE, they still must ensure that their staff are able to use
the MDE effectively in order for people with disabilities to benefit.
---------------------------------------------------------------------------
\294\ Nancy R. Mudrick et al., Presence of Accessible Equipment
and Interior Elements in Primary Care Offices, 3.1 Health Equity 275
(2019), https://dredf.org/wp-content/uploads/2019/10/Presence-of-Accessible-Equipment-and-Interior-Elements-in-Primary-Care-Offices.pdf.
---------------------------------------------------------------------------
Response: OCR recognizes that in the absence of an enforceable
standard that requires providers to acquire MDE with specific features,
providers may not acquire accessible MDE. This may be due in part to
the cost of accessible MDE exceeding the cost of non-accessible MDE and
the durability of existing MDE. OCR also agrees that if a provider
acquires accessible MDE, such as an adjustable exam table, but does not
ensure that staff can effectively use the table and assist patients
with transfers, patients with disabilities will not benefit. For the
MDE Standards to be effective, providers must also know how to use
accessible MDE. OCR will continue to enforce existing nondiscrimination
obligations and, as noted above, is in the process of rulemaking to
adopt enforceable standards for accessible MDE under section 504.
Comment: Numerous commenters requested that OCR consider expanding
on the existing MDE Standards. Some commenters requested that OCR
create new standards specific to individuals with visual impairments,
sensory limitations, or cognitive disabilities. Some commenters also
requested that OCR expand the MDE Standards to non-diagnostic medical
equipment in addition to MDE, with others, requesting that OCR
determine the scoping requirements that covered entities would have to
follow under the MDE Standards.
Response: OCR appreciates commenters' suggestions. Because we are
not requiring providers to abide by the MDE Standards in this
rulemaking, we will not determine whether to expand the MDE Standards
beyond diagnostic equipment, create new standards unique to individuals
with other disabilities, or determine the scoping requirements of the
MDE Standards. However, we will consider these recommendations and note
that regardless of whether medical equipment is diagnostic, a covered
entity must make its health programs and activities accessible to
individuals with disabilities.
Comment: Numerous commenters stated that because of inaccessible
MDE, many patients with disabilities have been asked to bring someone
with them to appointments in order to help them transfer onto MDE. The
commenters state that it is never appropriate to require this of a
patient.
Response: Existing Federal civil rights laws, including section
504, title II of the ADA, and the existing section 1557 implementing
regulation, forbid providers from requiring a patient with a disability
to bring their own aide or support person to an appointment to assist
them with transfers. Any person who has been required by a provider to
bring another person to an appointment to assist with transfers is
encouraged to file a complaint with OCR.
Comment: One commenter stated that the use of accessible MDE could
be considered a reasonable modification for persons with disabilities
as required by existing disability rights laws.
Response: Providing accessible MDE is one method that providers can
use to ensure that a patient with a disability is able to access a
provider's programs and activities. A provider would likely violate
Federal disability discrimination laws like section 504, the ADA, and
section 1557 if the health programs and activities they provide,
including preventative and diagnostic care, are not accessible to
people with disabilities.
Comment: One commenter stated that while requiring covered entities
to obtain and use accessible MDE would be beneficial to people with
disabilities, in certain circumstances it may be sufficient for a
covered entity without accessible MDE to offer transportation to
another covered entity with accessible MDE.
Response: While a provider acquiring and using accessible MDE so
that its patients with disabilities are able to receive health care in
its offices is preferrable, there may be specific situations where it
is appropriate for the provider to offer transportation to another
facility that has accessible MDE.
Comment: Many commenters stated that they consider accessible MDE
to raise both network adequacy and benefit design implications. They
believed that a lack of accessible MDE leads to a lack of in-network
care and a lack of network adequacy, which they alleged to be
discriminatory. They stated that benefit design could be used to embed
accessible MDE requirements. They also stated that accessibility should
also be considered in conjunction with time and distance standards to
determine network adequacy.
Response: OCR appreciates commenters raising these important
opinions concerning how the presence of accessible MDE affects network
adequacy and benefit design. While OCR has decided not to explicitly
address accessible MDE in this rulemaking, we refer commenters to the
discussion of network adequacy and benefit design under this section.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, OCR is finalizing the nondiscrimination in health
insurance coverage and other health-related coverage provision at Sec.
92.207 as proposed, with modification. We have revised Sec.
92.207(b)(6) to clarify that the integration requirement extends to
practices that result in the serious risk of institutionalization or
segregation. We have revised Sec. 92.207(c) to strike the text
following ``legitimate,
[[Page 37632]]
nondiscriminatory reason for'' and now the text prohibits ``denying or
limiting coverage of the health service or determining that such health
service fails to meet applicable coverage requirements including
reasonable medical management techniques such as medical necessity
requirements.'' This section also provides that ``such coverage denial
or limitation must not be based on unlawful animus or bias, or
constitute a pretext for discrimination. Nothing in this section is
intended to preclude a covered entity from availing itself of
protections described in Sec. Sec. 92.3 and 92.302.'' We have also
made conforming edits to include ``or any combination thereof'' to the
list of prohibited bases of discrimination found Sec. 92.207(a) and
(b)(1) and (2).
Prohibition on Sex Discrimination Related to Marital, Parental, or
Family Status (Sec. 92.208)
In Sec. 92.208, OCR proposed to prohibit covered entities 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 implementing regulations. See 45 CFR 86.40(a).
Section 92.208 provides 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.\295\
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\295\ This final rule does not preclude the application of
Federal laws regarding eligibility criteria for certain Federal
programs under CMS.
---------------------------------------------------------------------------
The comments and our responses regarding Sec. 92.208 are set forth
below.
Comment: Many commenters supported the inclusion of Sec. 92.208
because it provides clarity for patients and providers and brings OCR
into alignment with other nondiscrimination practices set by section
1557, ensuring that all vulnerable groups receive the same level of
civil rights protections. Several commenters mentioned that this change
aligned with the title IX regulation, which has, since 1975, explicitly
interpreted sex discrimination to encompass discrimination on the basis
of current, potential, or past parental, family, or marital status that
treats persons differently on the basis of sex. Commenters also raised
other civil rights statutes, like the Civil Service Reform Act that is
applicable to Federal employees, which explicitly includes protections
based on marital status.\296\
---------------------------------------------------------------------------
\296\ See Public Law 95-454, sec. 101, 92 Stat. 1111, 1113-14
(Oct. 13, 1978), codified at 5 U.S.C. 2301(b).
---------------------------------------------------------------------------
Response: OCR agrees that including this provision brings
regulations in line with other civil rights laws that recognize
policies that treat people differently on the basis of sex in applying
rules related to marital, parental, or family status,\297\ as
discrimination on the basis of sex, particularly, and as stated in the
Proposed Rule's preamble, the Department's longstanding acknowledgment
of this interpretation of title IX, at 45 CFR 86.40(a).
---------------------------------------------------------------------------
\297\ The term ``family status'' used in this rule is distinct
from any defined terms in other rules, including ``familial status''
as defined in the Fair Housing Act, 42 U.S.C. 3601 et seq.
---------------------------------------------------------------------------
Comment: Numerous commenters supported proposed Sec. 92.208. Some
of these commenters explained that taking marital, parental, or family
status into account has engendered arbitrary policies at medical
facilities that create barriers to accessing health care, which can
result in harmful and inequitable treatment of individuals. Many
commenters stated that this provision will help alleviate the denial of
care some women experience because they are single, unmarried,
childless, or not in the presence of a male partner or husband when
they are seeking, for instance, birth control.
Response: OCR agrees that absent the prohibition on taking sex into
account in marital, parental, or family status, covered entities may
adopt arbitrary policies that could create unnecessary inequities and
result in harmful health outcomes. Section 92.208 prohibits
discrimination that applies different policies and procedures based on
sex in the context of marital, parental, or family status; it does not,
however, prohibit discrimination on the basis of marital status alone
(i.e., single, divorced, widowed, etc.). As discussed in the 2022 NPRM,
OCR encountered complaints, in the course of its enforcement work,
where covered entities applied different policies for married men and
married women. For example, OCR has settled cases 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. 87 FR 78878.
Comment: Many commenters supported the protections against
discrimination on the basis of sex in the context of marital, parental,
and family status contained in Sec. 92.208 because of their impact on
same-sex couples and the varying types of discrimination that this
group experiences, including past experiences of discrimination on the
basis of marital, parental, and family status alone. For example, some
commenters said that these protections are critical because, although
many same-sex couples live in committed relationships, they are less
likely to be married, largely due to laws that until recently
prohibited same-sex marriage. These protections, commenters argued,
help to insulate LGBTQI+ individuals who have experienced
discrimination in many health care settings, such as hospitals where
they have been denied visitation rights and authority to make medical
decisions impacting their loved ones' health conditions. Many
commenters highlighted that these forms of discrimination were well
documented during the AIDS crisis, when longtime partners were
regularly denied hospital visitation rights and lacked adequate
protections, even for discrimination based solely on marital status.
For similar reasons, some commenters stated that this provision would
protect families headed by same-sex couples, who may be denied the
right to make medical decisions for their children. These commenters
noted, that in the health care context, the involvement of family and
external support systems can improve health outcomes, management of
chronic illnesses, and continuity of care.
Response: OCR agrees that the prohibition on taking an individual's
sex into account in applying any rule concerning an individual's
current, perceived, potential, or past marital, parental, or family
status can be critical in health care settings involving medical
decision-making and visitation rights, particularly for same-sex
couples. Section 92.208 prohibits a covered entity from implementing a
policy related to marital, parental, or family status that treats
individuals differently on the basis of sex (e.g., male spouses of
women can make medical decisions for their children but non-male
spouses of women cannot, or allowing visitation rights for a married
heterosexual couple but denying visitation rights to a married same-sex
couple), but it does not prohibit covered entities from making
distinctions based upon their marital status alone (e.g., applying
different rules to married and nonmarried individuals that do not
distinguish based on an individual's sex).
Comment: Other commenters also discussed the impact that the
protections contained in proposed
[[Page 37633]]
Sec. 92.208 have on same-sex couples seeking fertility treatments.
They stated that these protections are needed because some health
insurance coverage or other health-related coverage include in vitro
fertilization (IVF) treatments as a covered benefit for heterosexual
married couples, but not for same-sex married couples. Some commenters
highlighted how, in their view, institutional policies' definition of
``infertility'' lead to such a discriminatory practice. This
establishes what commenters describe as an impossible standard for
same-sex couples to meet when seeking fertility treatment and coverage.
Response: OCR understands that not all covered health insurance
issuers offer fertility coverage or treatments. However, those that do
must offer such benefits in a nondiscriminatory manner. For example, a
covered health insurance issuer that offers fertility coverage or
treatments for married different-sex couples could not deny the same
coverage or treatments to married same-sex couples. section 1557's
prohibitions of discrimination apply across all covered health programs
and activities.
Comment: Other commenters who supported the inclusion of Sec.
92.208 stated that these protections are important because they help
ensure nondiscrimination against a wide range of family structures.
Response: OCR reminds commenters that this section prohibits
discrimination on the basis of sex when applying rules related to
marital, parental, and family status, and is not to be conflated with
prohibition against discrimination on the basis of these statuses
alone. Thus, policies and procedures that include conditions or
limitations tied to these statuses would not run afoul of this rule
unless they applied differently based on the sex of the individuals.
Comment: Some commenters supported Sec. 92.208 because in their
view, a medical practice cannot refuse a female patient solely because
she has a female spouse or partner, as this could constitute a denial
on the basis of association.
Response: OCR agrees that a medical practice may not refuse to see
a prospective female patient based solely on the fact that the patient
has a female spouse if they otherwise accept married individuals into
their practice. This is because the refusal would be based on the sex
of the prospective patient and would therefore constitute sex
discrimination related to marital status. And, as noted in the Proposed
Rule, a denial based on a female patient having a female spouse or
partner would also constitute discrimination on the basis of
association, which is specifically addressed in Sec. 92.209, as the
refusal would be based on the sex of an individual with whom the
patient is known to have a relationship or association. 87 FR 47880.
Comment: Many commenters opposed the inclusion of Sec. 92.208,
stating that if Congress meant to include ``marital, parental, or
family status'' in section 1557 it would have done so, just as it did
in part in the Equal Credit Opportunity Act (ECOA) (including ``marital
status'') and the Fair Housing Act (FHA) (including ``familial
status''). These commenters contended that adding these protections
would make the addition of marital and familial status a mere
surplusage to the text of the ECOA and FHA, and that it would include
additional terms to their application despite neither statute
explicitly including the additional terms. Some commenters who opposed
the provision also stated that OCR needs to account for the additional
costs of including these changes, especially as it may impact religious
institutions that provide marital counseling services.
Response: OCR disagrees that clarifying these protections under
section 1557 impacts either the ECOA or FHA.\298\ While these statutes
bar discrimination on the basis of an individual's marital or familial
status per se, Sec. 92.208 bars discrimination on the basis of sex as
it relates to marital and family status. As discussed in the 2022 NPRM,
87 FR 47878, this final rule's interpretation is consistent with a
parallel, longstanding prohibition included in the Department's title
IX implementing regulations, 45 CFR 86.40(a). OCR has consistently
interpreted the scope of section 1557's prohibition on the ground of
sex consistently with the scope of title IX's prohibition of
discrimination on the ground of sex, which includes discrimination
within the context of marital, parental, or family status.\299\ This
provision will apply similar standards already enforced by OCR, and we
do not anticipate additional costs for covered entities, including
religious institutions beyond the costs already captured in the
Regulatory Impact Analysis below for recipients to seek assurances of
religious and conscience exemptions under Sec. 92.302(b).
---------------------------------------------------------------------------
\298\ Cf. Conn. Nat'l Bank v. Germain, 503 U.S. 249, 253 (1992)
(courts must give effect to statutes with overlapping coverage ``so
long as there is no `positive repugnancy' between the two'').
\299\ As discussed in the 2022 NPRM, 87 FR 47878, 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. See U.S. Dep't of Health & Hum. Servs., Off. for Civil
Rts., Sex Case Summaries: Summary of Selected OCR Compliance
Activities, https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/examples/sex-discrimination/index.html.
---------------------------------------------------------------------------
Discrimination on the Basis of Pregnancy-Related Conditions
In proposing Sec. 92.208, OCR stated its view that it could be
beneficial to include a provision that would specifically prohibit
discrimination on the basis of pregnancy-related conditions as a form
of sex-based discrimination, and sought comment on how to include such
a provision in the final rule. 87 FR 47879. This proposal was
specifically requesting comment on a stand-alone provision, separate
from the inclusion of ``pregnancy or related conditions'' in Sec.
92.101(a)(2)'s inclusion of the term. Including such a provision at
Sec. 92.208 would mirror its placement to those of the Department's
title IX implementing regulations at 45 CFR 86.21(c), 86.40, 86.52(b),
and 86.57. The 2016 Rule explicitly included ``pregnancy, false
pregnancy, termination of pregnancy, or recovery therefrom, childbirth
or related medical conditions'' in former Sec. 92.4. While the 2020
Rule did not include any definition of ``sex discrimination,'' it
indicated that section 1557 would be enforced consistent with title IX
and its implementing regulations, which includes these terms. For the
reasons explained below, we decline to add ``pregnancy or related
conditions'' to Sec. 92.208.
The comments and our responses regarding this request for comment
are set forth below.
Comment: Many commenters supported the inclusion of a provision
that includes pregnancy-related conditions as a prohibited form of
discrimination on the basis of sex. Numerous commenters discussed that
pregnancy-related conditions are inherently linked to sex because
discrimination on that basis affects an individual's ability to make
decisions about their reproductive health and life, and affects
individuals' ability to be equal and participating members of society.
Response: OCR appreciates these comments and agrees that clarifying
that discrimination on the basis of sex includes pregnancy-related
conditions, as Sec. 92.101(a)(2)(ii) (``discrimination on the basis of
sex includes . . . pregnancy or related conditions'') does, is critical
to ensuring that individuals are protected against this form of sex
discrimination. OCR also agrees that discrimination on the basis of
[[Page 37634]]
pregnancy or related conditions can negatively affect an individual's
ability to make decisions about their reproductive health and life, and
their ability to be equal and participating members of society.
Comment: Many commenters who supported the inclusion of pregnancy-
related conditions discussed the need for clarity in light of the
Supreme Court's decision in Dobbs. Commenters contended that pregnancy-
related conditions should be included in the definition of ``sex
discrimination'' because it would reinforce covered entities' legal
obligations under section 1557, and would allow OCR to address related
discrimination more holistically and inclusively.
Commenters maintained that pregnancy protections are critical in
light of total or near-total abortion bans in some States after the
Dobbs decision. Commenters explained that this legal uncertainty
warrants clarity and explicit protections for pregnancy-related
conditions, including termination of pregnancy, because patients and
providers have been left uncertain and fearful of their ability to
provide care, are subjected to additional scrutiny, and face the
possibility of criminal prosecution and civil litigation in States that
have limited reproductive health care options.
Response: OCR affirms that under section 1557, covered entities may
not discriminate against individuals for their pregnancy-related
decisions, past, present, or future. OCR declines to add in additional
protections outside of the scope of this rule. At the same time, the
ACA itself provides that ``[n]othing in this Act shall be construed to
have any effect on Federal laws regarding--(i) conscience protection;
(ii) willingness or refusal to provide abortion; and (iii)
discrimination on the basis of the willingness or refusal to provide,
pay for, cover, or refer for abortion or to provide or participate in
training to provide abortion.'' 42 U.S.C. 18023(c)(2)(A).\300\ HHS will
comply with this provision.
---------------------------------------------------------------------------
\300\ The application of this final rule to covered entities
with conscience or religious freedom objections are discussed more
fully below in Sec. Sec. 92.3 (Relationship to other laws) and
92.302 (Notification of views regarding application of Federal
religious freedom and conscience laws).
---------------------------------------------------------------------------
Comment: Some commenters discussed privacy concerns involving
HIPAA, as some providers have worried that medical privacy may be
compromised when patients seek care or information, even if unrelated
to abortion. Commenters argued for the need to include pregnancy-
related protections under section 1557 so that patients are not
discriminated against for their pregnancy-related decisions, past,
present, or future.
Response: OCR appreciates the privacy concerns raised by these
commenters. OCR affirms that under section 1557, covered entities may
not discriminate against individuals for their pregnancy-related
decisions, past, present, or future, including where the patient
discloses the information or where such information is contained in
medical records. Indeed, HIPAA was enacted to protect such sensitive
patient health information from being disclosed without the patient's
consent or knowledge. Separately, OCR is considering revisions to the
HIPAA Privacy Rule to strengthen privacy protections for individuals'
protected health information related to reproductive health care. See
HIPAA Privacy Rule To Support Reproductive Health Care Privacy, notice
of proposed rulemaking, 88 FR 23506 (Apr. 17, 2023).
Comment: Other commenters urged OCR to address pregnancy-related
conditions but to do so elsewhere in the rule, either in the provisions
on what constitutes discrimination on the basis of sex (Sec.
92.101(a)(2)), equal program access on the basis of sex (Sec.
92.206(b)), or nondiscrimination in health insurance coverage (Sec.
92.207(b)). These commenters explained that confining the discussion of
the pregnancy-related conditions to Sec. 92.208 (Prohibition on sex
discrimination related to marital, parental, or family status) risked a
narrow interpretation and application of the prohibition, and could
lead providers to consider this prohibition to be limited in context
and scope. Commenters emphasized that pregnancy-related protections are
relevant to a wide range of conduct beyond the context of marital,
parental, or familial status and should not exclude individuals who are
single. Commenters also raised that pregnancy-related discrimination
applies to a broad scope of protected services, such as the decision to
access certain reproductive health care services (e.g., contraception),
as well as denials of reproductive services and insurance coverage.
Many commenters suggested that OCR include pregnancy-related conditions
in a standalone provision, because OCR could then further clarify the
interplay between section 1557 and other Federal statutes or
regulations related to termination of pregnancy that may apply to
covered entities.
Response: OCR appreciates these comments. In the 2022 NPRM, OCR
considered including additional details regarding discrimination on the
basis of ``pregnancy or related conditions'' in Sec. 92.208 to mirror
its placement to the Department's title IX implementing regulations at
45 CFR 86.21(c), 86.40, 86.52(b), and 86.57. However, having considered
the comments received, OCR concluded that the rule is better served by
leaving ``pregnancy or related conditions'' in Sec. 92.101(a)(2),
which outlines the scope of discrimination on the basis of sex. The
Department believes Sec. 92.101(a)(2)--which addresses forms of sex
discrimination generally--is a better location, so as to not suggest
that discrimination based on pregnancy or its related conditions is
limited to instances of discrimination involving only marital,
parental, or family status.
Comment: Many commenters supported the inclusion of pregnancy-
related conditions, but suggested additional changes to the rule,
including explicit descriptions of what pregnancy or related conditions
encompasses. Several commenters encouraged OCR to add language
establishing that pregnancy-related conditions specifically include
pregnancy termination, childbirth, false pregnancy, ectopic pregnancy,
miscarriage, and recovery, including any refusal of service or
procedure based on any other protected basis under the rule.
Response: OCR agrees that protections for ``pregnancy or related
conditions'' are critical and affirms that covered entities may not
discriminate against individuals based on pregnancy or related
conditions under section 1557. However, additional language to identify
what the term ``pregnancy or related conditions'' means is not
necessary given that the regulatory language is not intended to be
exhaustive as explained above. As noted in the NPRM, OCR understands
the term as including childbirth, false pregnancy, termination of
pregnancy, and recovery therefrom, which are the ``grounds'' prohibited
under title IX.\301\ 87 FR 47878.
---------------------------------------------------------------------------
\301\ 45 CFR 86.40(a).
---------------------------------------------------------------------------
Comment: Some commenters opposed the inclusion of pregnancy-related
conditions. One commenter cautioned OCR to not rely on the Dobbs
decision or its effects as a basis for prohibiting discrimination on
pregnancy-related conditions, including pregnancy termination. Some
commenters stated Dobbs held that the regulation of abortion was
returned to the States, and thus, OCR cannot propose a provision that
is inclusive of abortion, which would be contrary to Congressional and
judicial prohibitions. Other commenters, despite acknowledging
[[Page 37635]]
that the title IX regulations have since 1975 included ``pregnancy and
related conditions'' (which includes termination of pregnancy), argued
that because the term ``termination of pregnancy'' is not defined in
the title IX regulations, the term should not be adopted here. A
commenter suggested that OCR either not include ``termination of
pregnancy'' as a pregnancy-related condition or clarify that
``termination of pregnancy'' does not include abortion because abortion
is not morally equivalent to pregnancy or childbirth and should not be
treated as such. Some commenters who opposed including pregnancy-
related conditions argued that if the final rule includes such a term,
OCR must account for its impact.
Response: OCR appreciates comments regarding the inclusion of
``pregnancy or related conditions,'' including those concerns related
to Dobbs. OCR is not promulgating this rule in response to Dobbs, which
addressed the question of whether the Constitution provides a right to
abortion. This rule does not purport to interpret the Constitution, nor
does it address whether States may regulate or ban abortions. Indeed,
we emphasize that section 1303 of the ACA specifically states that
``[n]othing in this Act shall be construed to preempt or otherwise have
any effect on State laws regarding the prohibition of (or requirement
of) coverage, funding, or procedural requirements on abortions,
including parental notification or consent for the performance of an
abortion on a minor.'' 42 U.S.C. 18023(c)(1). Pursuant to that
provision, this rule should not be read to override any such State
abortion laws. OCR reiterates that a covered provider does not engage
in discrimination prohibited by section 1557 if it declines to provide
abortions based on religious or conscience objections to performing the
care, based on a professional or business judgement about the scope of
services it wishes to offer, or for any other nondiscriminatory reason.
This rule implements section 1557 of the ACA, which prohibits
discrimination on the basis of race, color, national origin, sex, age,
or disability in covered health programs or activities by incorporating
the ``grounds prohibited under'' title VI, title IX, the Age Act, and
section 504. Under title IX, discrimination based on pregnancy has been
understood to constitute sex discrimination since 1975. Consistent with
this long-standing interpretation, OCR will consider complaints of sex
discrimination, including discrimination based on pregnancy or related
conditions, on a case-by-case basis, and it will look to title IX and
section 1557 case law to determine whether discrimination on the basis
of sex has occurred. OCR is unaware of any instance in which a covered
entity has been required to provide an abortion under title IX, title
VI, the Age Act, or section 504.
Consistent with this understanding of the incorporated statutes,
the relevant case law, and historical practice, OCR emphasizes that a
covered provider's decision not to provide abortions is not itself sex
discrimination, under section 1557. Section 1557 prohibits
discrimination on the basis of race, color, national origin, sex, age,
or disability in covered health programs or activities. As noted above,
a covered provider that generally offered abortion care could violate
that prohibition if, for example, it generally offers or provides
abortions to patients but refused to offer or provide an abortion to a
particular patient because of that patient's race or disability. But a
covered provider does not engage in discrimination prohibited by
section 1557 if it declines to provide abortions based on religious or
conscience objections to performing the procedure, based on a
professional or business judgment about the scope of the services it
wishes to offer, or for any other nondiscriminatory reason.
Comment: Many commenters stated that Dobbs prevents OCR from
protecting access for abortion care through its proposed definition of
sex, because the Supreme Court held there is no constitutional right to
an abortion and returned the issue to the States. Other commenters also
stated that, because Dobbs returned the issue of abortion to the
States, OCR cannot create regulations that would create conflicts with
State laws banning or restricting abortion. Additionally, these
commenters raised section 1303 as another basis under which the ACA
prohibits OCR from issuing regulations that preempt State laws
regarding abortion.
Other commenters raised the view that Dobbs reaffirmed Bray v.
Alexandria Women's Health Clinic, 506 U.S. 263 (1993), which held that
opposition to abortion does not constitute animus against women. They
contend that OCR cannot therefore define sex to include pregnancy
termination. Commenters also stated that Dobbs established that there
is no compelling government interest in promoting abortion, and
therefore OCR has no authority to promulgate rules in support of
abortion. A few commenters expressed that under the ``major questions''
doctrine, OCR cannot set an abortion policy such as prohibiting
discrimination on the basis of pregnancy termination without explicit
authorization from Congress.
Response: OCR appreciates the commenters' concerns and their
interpretation of Dobbs. The Dobbs opinion did not address title IX or
section 1557. Dobbs nowhere prohibits OCR from issuing regulations or
promulgating rules under its statutory authorities. Indeed, under
section 1557, HHS is charged by Congress with the elimination of
discriminatory barriers in the administration and provision of a
diverse range of health programs and activities.
As OCR has previously stated, this rule does not establish a
Federal policy requiring or promoting abortion services. Although OCR
has concluded that section 1557 does not require the Department to
incorporate the language of title IX's abortion neutrality provision,
see Sec. 92.208 (Prohibition on sex discrimination related to marital,
parental, or family status), as we note throughout this preamble, OCR
emphasizes that a covered provider's decision not to provide abortions
does not itself constitute discrimination in violation section 1557.
Section 1557 prohibits discrimination on the basis of race, color,
national origin, sex, age, or disability in covered health programs or
activities.
It bears emphasis that nothing in the ACA, including section 1557,
has ``any effect on Federal laws regarding--(i) conscience protection;
(ii) willingness or refusal to provide abortion; and (iii)
discrimination on the basis of the willingness or refusal to provide,
pay for, cover, or refer for abortion or to provide or participate in
training to provide abortion.'' 42 U.S.C. 18023(c)(2)(A). In addition,
nothing in the ACA, including section 1557, preempts or has any effect
on State laws regarding ``the prohibition of (or requirement of)
coverage, funding, or procedural requirements on abortions'' as
provided in section 1303 of the ACA, 42 U.S.C. 18023(c)(1).
OCR's interest is protecting individuals against prohibited forms
of discrimination under section 1557 when accessing the range of health
programs and activities covered under the statute. OCR also disagrees
that the ``major questions'' doctrine is implicated by its promulgation
of rules that protect individuals from discrimination on the basis of
sex consistent with the manner in which the term has long been
interpreted in the title IX context.
Comment: Many commenters stated that Dobbs had--and continues to
have--a significant impact that warrants section 1557's protections
against
[[Page 37636]]
discrimination on the basis of pregnancy or related conditions. Many
commenters discussed that Dobbs limited access to abortion nationwide
and created a complex web of State laws that ban or severely restrict
access to care. These commenters stated that certain communities,
including people of color, people with low incomes, immigrants, young
people, people with disabilities, and LGBTQI+ individuals are most
likely to face legal barriers to accessing abortion care, including an
increased threat of arrest and prosecution in States hostile to
abortion.
Many commenters also posited that States' efforts to restrict
access to abortion have resulted in further challenges to accessing
other reproductive health care, including contraception, fertility care
and treatment, and miscarriage or early pregnancy loss management.
Commenters cited examples from multiple States where women experiencing
miscarriages have been denied care even as their pregnancy-related
complications threaten their health and lives.
Response: OCR understands commenters' concerns regarding the
negative health impacts stemming from the Dobbs decision, including on
those with pregnancy-related conditions. We emphasize, as we have
repeatedly throughout this preamble, that this rule is neither a
response to Dobbs nor affected by that decision. This rule rests on the
application of section 1557's nondiscrimination prohibition, and the
longstanding interpretation of title IX's prohibition on sex
discrimination to include discrimination on the basis of pregnancy and
related conditions.
Comment: Many commenters raised concerns about access to
prescriptions related to contraception, miscarriages or early pregnancy
loss, and medication abortion. Commenters also raised concerns about
access to drugs prescribed to treat conditions like chronic disease or
illness that are unrelated to abortion, but may have the effect of
terminating a pregnancy. Some commenters explained that pharmacists are
fearful about dispensing medications that could terminate a pregnancy
even when the medication is not prescribed for the purpose of abortion,
and in some instances, pharmacists have refused to fill prescriptions
in certain States that have banned abortion.
In States that have banned abortion, commenters noted that
physicians, health care providers, and pharmacists fear they will be
criminally prosecuted under State law, leading to denials or delays in
lawful access to medications to treat conditions unrelated to abortion.
For instance, many commenters explained that certain drugs prescribed
to treat health conditions such as cancer, arthritis, ulcers,
autoimmune diseases, or other chronic conditions are being denied or
limited because they can result in termination of a pregnancy.
Specifically, commenters relayed that some treatments for conditions
such as breast cancer, brain cancer, prostate cancer, alcoholism, post-
traumatic stress disorder, and depression involve drugs that are being
denied because of an indirect potential relationship with pregnancy
termination.
Similarly, many commenters requested clarification that section
1557's prohibitions on discrimination protect access to contraception
in the retail pharmacy setting. They raised concerns and described
instances where individuals are denied access to hormonal contraception
at a pharmacy that provides other forms of contraceptives. Some
commenters opined that a pharmacy's refusal to provide prescribed
medication to enable IUD (intrauterine device) insertion, or to treat
an incomplete miscarriage, should be considered a section 1557
violation.
Commenters were concerned that such discrimination is not only sex
and disability discrimination, but also creates additional and
unnecessary barriers to prescription drugs that people need to live and
maintain their health. For example, many commenters discussed that
people with disabilities are increasingly denied or subjected to
barriers to obtaining methotrexate, which is a prescription drug used
to treat cancer and autoimmune conditions, because of the drug's
potential effects on pregnancy. Many commenters explained that a
pharmacist's refusal to fill an individual's prescription or a
pharmacist's decision to not stock a specific drug or class of drugs
inevitably harms persons with disabilities and women, especially those
experiencing miscarriages and early pregnancy loss. They stated that
women are also more likely than men to have autoimmune diseases for
which many of these drugs are prescribed.
Response: OCR appreciates comments relating to access to lawfully
prescribed and medically necessary medications. To start, OCR notes
that, on September 29, 2023, after the close of the comment period for
this rule, OCR issued revised guidance to pharmacies that supersedes
the guidance referred to by some commenters.\302\ If a covered entity
denies or delays lawful access to medications to support persons with
disabilities, treat cancer, or treat an autoimmune condition, that
refusal could violate section 1557 if, for example, the refusal is on
the basis of a prohibited ground, such as the person's race, age,
disability, or sex. But, as OCR clarified in its updated guidance to
the nation's pharmacies, section 1557 does not require pharmacies to
fill prescriptions for medication for the purpose of abortion, nor does
the guidance suggest or imply an obligation of pharmacies to fill
prescriptions for medication in violation of State laws, including
those banning or restricting abortion.\303\ OCR provided several
examples in the guidance, in which denying lawfully prescribed
medication to customers may violate civil rights laws.\304\ For
example, where a treating physician diagnoses a miscarriage complicated
by a uterine infection and orders an antibiotic to treat a patient's
chills, fever, and vaginal bleeding, a pharmacy that refuses to provide
the antibiotic because of concern that subsequent care may include an
abortion may be discriminating on the basis of sex. OCR will evaluate
and apply all applicable statutory protections, including relevant
religious freedom and conscience protections, on a case-by-case basis.
---------------------------------------------------------------------------
\302\ See U.S. Dep't of Health & Hum. Servs., Guidance to the
Nation's Retail Pharmacies: Obligations Under Federal Civil Rights
Laws to Ensure Nondiscriminatory Access to Health Care at
Pharmacies, (Sept. 29, 2023), https://www.hhs.gov/civil-rights/for-individuals/special-topics/reproductive-healthcare/pharmacies-guidance/index.html. On April 5, 2024, the court in State of Texas
v. Becerra et al., No. 7:23-cv-00022-DC, Order for S.J., ECF No. 69
(W.D. Tex.), held that the revised guidance mooted plaintiffs' legal
challenge to the superseded guidance.
\303\ See U.S. Dep't of Health & Hum. Servs., Guidance to
Nation's Retail Pharmacies: Obligations under Federal Civil Rights
Laws to Ensure Nondiscriminatory Access to Health Care at Pharmacies
(September 29, 2023), https://www.hhs.gov/civil-rights/for-individuals/special-topics/reproductive-healthcare/pharmacies-guidance/index.html (``nor does the guidance suggest or imply an
obligation of pharmacies to fill prescriptions for medication in
violation of State laws, including those banning or restricting
abortion'').
\304\ Id.
---------------------------------------------------------------------------
In addition, the ACA is hardly silent on the issue of abortion. It
contains an elaborate set of rules for when and how a qualified health
plan may refuse or be prohibited from providing or paying for certain
abortions. See 42 U.S.C. 18023(a)-(b). It further specifies that State
laws regarding abortion are not preempted and that ``nothing in this
act shall be construed to have effect on federal laws regarding--(i)
conscience protections; (ii) willingness or refusal to provide
abortion; and (iii) discrimination on the basis of willingness or
refusal to provide, pay
[[Page 37637]]
for, cover, or refer for abortion or to provide or participate in
training to provide abortion.'' Id. at 18023(c).
Comment: OCR sought comment on the title IX abortion neutrality
provision's inclusion and on other possible readings of that provision.
Although OCR also sought comment on 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,\305\ no
comments addressed this specifically. Many commenters supported OCR's
proposal to not import the language of title IX's abortion neutrality
provision into section 1557's final rule. Doing so, they contended,
would undermine and be contrary to OCR's implementation of section
1557, which is to eliminate barriers and expand access to health care
and coverage. These commenters discussed how abortion is a critical
form of health care and patients seek or need to terminate a pregnancy
for a wide variety of reasons.
---------------------------------------------------------------------------
\305\ 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
part 229; Corporation for National and Community Service, 45 CFR
part 2555; Department of Agriculture, 7 CFR part 15d.; Department of
Commerce, 15 CFR part 8a; Department of Defense, 32 CFR part 196;
Department of Energy, 10 CFR part 1040; Department of Homeland
Security, 6 CFR part 17; Department of Housing and Urban
Development, 24 CFR part 3; Department of the Interior, 43 CFR part
41; Department of Justice, 28 CFR part 54; Department of Labor, 29
CFR part 36; Department of State, 22 CFR part 146; Department of
Transportation, 49 CFR part 25; Department of the Treasury, 31 CFR
part 28; Department of Veterans Affairs, 38 CFR part 23;
Environmental Protection Agency, 40 CFR part 5; Federal Emergency
Management Agency, 44 CFR part 19; General Services Administration,
41 CFR part 101-4; National Aeronautics and Space Administration, 14
CFR part 1253; National Archives and Records Administration, 36 CFR
part 1211; National Science Foundation, 45 CFR part 618; Nuclear
Regulatory Commission, 10 CFR part 5; Small Business Administration,
13 CFR part 113; and Tennessee Valley Authority, 18 CFR part 1317.
---------------------------------------------------------------------------
Response: OCR's determination to not incorporate title IX's
abortion neutrality provision is based on our conclusion that doing so
is not required and unnecessary as the ACA itself speaks to this issue.
The ACA provides that nothing in the statute, including section 1557,
has ``any effect on Federal laws regarding (i) conscience protection;
(ii) willingness or refusal to provide abortion; and (iii)
discrimination on the basis of the willingness or refusal to provide,
pay for, cover, or refer for abortion or to provide or participate in
training to provide abortion.'' 42 U.S.C. 18023(c)(2)(A). By contrast,
the ACA does not contain specific language directing the incorporation
of title IX's abortion neutrality provision. That section 1557 does not
require its incorporation is therefore the better reading of the
statute with regard to title IX. We reiterate, moreover, that this rule
does not--and indeed, cannot--create a right to abortion; it operates
only to prohibit discrimination on specific prohibited grounds.
Comment: Several commenters highlighted the differences between
section 1557's coverage of health care from title IX's coverage of
education because the decision to receive health care from a particular
provider is often driven by factors, including geographic location,
cost, insurance coverage, the type of care being sought, and the
urgency of that care. Many other commenters stated that importing title
IX's abortion neutrality provision would allow denials of care that can
directly harm patients, including putting at risk a patient's life or
health.
Response: OCR agrees with commenters that health care is
fundamentally different from education. And although section 1557
incorporates ``the ground prohibited under'' title IX and the
``enforcement mechanisms provided for and available under'' that
statute, 42 U.S.C. 18116(a), it does not incorporate title IX's other
provisions. Title IX's abortion neutrality provision does not purport
to define what constitutes prohibited sex discrimination under title
IX--the ``ground prohibited'' under that statute--and it is not an
enforcement mechanism; it provides only that nothing in title IX shall
be construed to require or prohibit any person or entity to provide or
pay for abortion or related benefit or service.
Congress made clear that the ACA, including section 1557, would
have no effect on several specific Federal laws protecting individuals
and entities that refuse to provide abortions. See 42 U.S.C.
18023(c)(2)(A). The ACA itself restates provisions of longstanding
Federal law by making clear in 18023(c)(2)(A) that ``nothing in this
act shall be construed to have effect on federal laws regarding--(i)
conscience protections; (ii) willingness or refusal to provide
abortion; and (iii) discrimination on the basis of willingness or
refusal to provide, pay for, cover, or refer for abortion or to provide
or participate in training to provide abortion.'' These provisions
reiterate existing Federal restrictions on abortion. For example, the
Weldon Amendment forbids funds appropriated to HHS 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.'' \306\ The Coats-Snowe Amendment
forbids discriminating against an entity that refuses to undergo
training in performance of or referrals for abortions.\307\ 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.'' \308\ 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.'' \309\ The Church Amendments also
prohibit 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.''
\310\ The same nondiscrimination protections also apply to health care
personnel who refuse to perform or assist in the performance of
sterilization procedures or abortion.\311\ In addition, some of HHS's
programs and services are specifically governed by abortion
restrictions in the underlying statutory authority or program
authorization.\312\ The ACA also contains a variety of ``special
rules'' that apply specifically to
[[Page 37638]]
abortion coverage and services.\313\ Each of these laws continues to
apply and is not affected by this rule. Accordingly, it is not
necessary to incorporate title IX's abortion neutrality provision.
---------------------------------------------------------------------------
\306\ Consol. Appropriations Act, 2024, Public Law 118-47, div.
H, tit. V, section 507(d)(1), 138 Stat. 460, 703 (Mar. 23, 2024).
See also, e.g., id. sections 506-07, 138 Stat. 460, 703 (Hyde
Amendment provisions).
\307\ 42 U.S.C. 238n(a).
\308\ 42 U.S.C. 300a-7(d).
\309\ 42 U.S.C. 300a-7(b)(2)(A).
\310\ 42 U.S.C. 300a-7(c)(1); see also U.S. Dep't of Health &
Hum. Servs., Guidance on Nondiscrimination Protections under the
Church Amendments, https://www.hhs.gov/conscience/conscience-protections/guidance-church-amendments-protections/index.html.
\311\ 42 U.S.C. 300a-7(c)(1).
\312\ 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.
\313\ See 42 U.S.C. 18023(b).
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OCR emphasizes that a covered provider's decision not to provide
abortions or abortion coverage does not itself constitute
discrimination in violation section 1557. As described above, section
1557 prohibits discrimination on the basis of race, color, national
origin, sex, age, or disability in covered health programs or
activities. As such there may be nondiscriminatory reasons for a
provider not to offer abortion care or coverage. A covered entity does
not engage in discrimination prohibited by section 1557 if it declines
to provide abortions based on religious or conscience objections to
performing the procedure, based on a professional or business judgment
about the scope of the services it wishes to offer, or for any other
nondiscriminatory reason.
Comment: Many commenters who supported OCR's proposal noted that
section 1557 does not require incorporation of title IX's abortion
neutrality provision because if Congress wanted to include such a
provision, it would have done so either by explicitly referencing title
IX's abortion neutrality provision or by including text matching 20
U.S.C. 1688. Commenters suggested that silence on the incorporation or
importation of title IX's abortion neutrality provision is not an
oversight on the part of Congress, but instead an intentional decision,
as Congress legislates with knowledge of the basic rules of statutory
construction.
Many commenters stated that the Congressional drafters of section
1557 did not pick and choose among the multiple title IX exceptions,
including those specific to military training, admissions decisions,
and membership practices of certain tax-exempt organizations, and that
there is no justification for OCR to do so either. They maintained that
the statute only references title IX for the prohibition of sex
discrimination. Commenters also said there was no need to import title
IX's abortion neutrality provision given the availability of existing
Federal statutory protections for covered entities and individuals who
object to the provision, payment, or referral of abortion services.
Many commenters noted that OCR proposed a process in which a covered
entity could seek an exemption based on conscience or religious
conflicts. These commenters argued that, where permitted by relevant
Federal laws, such analysis by OCR would also account for any potential
harm to third parties.
Response: For the reasons we set forth above, OCR maintains that
importing title IX's abortion neutrality provision in this rule is not
legally required by the statute.
Comment: Other commenters who supported not importing the title IX
abortion neutrality provision suggested that the final rule should
include the Proposed Rule's discussion that EMTALA protects emergency
care for pregnancy-related conditions, including termination of
pregnancy. Some commenters expressed that the final rule should make
clear that section 1557 incorporates section 1303(d) of the ACA, 42
U.S.C. 18023(d), which states that nothing in title I of the ACA
relieves any health care provider from providing emergency services as
required by EMTALA.
Response: OCR does not enforce EMTALA and directs commenters to the
discussion of EMTALA under Sec. 92.3. OCR notes that the 2022 NPRM's
discussion of EMTALA does not alter any requirements under section
1557, EMTALA's existing obligations, or the Department's previous
guidance regarding EMTALA. Nothing in this rule changes or otherwise
affects any health care provider's obligations with respect to EMTALA,
including with respect to the rights, remedies, procedures, or legal
standards available to individuals and entities under section 1303(c)
of the ACA.
Comment: Many commenters objected to OCR's proposal that it was not
required to import title IX's abortion neutrality provision in this
rule. These commenters argued that the provision must be included to
explicitly address that section 1557 and its implementing regulations
are abortion neutral. Some commenters maintained that the 2022 NPRM's
request for comment on whether ``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,''
87 FR 47879, constituted an ``abortion mandate'' that would
discriminate against providers and covered entities who object to
abortion. Some commenters stated that the inclusion of ``pregnancy or
related conditions'' as a form of sex discrimination without importing
title IX's abortion neutrality provision would strip providers of their
ability to object to pregnancy terminations. Some commenters
acknowledged that other Federal laws exist to protect religious freedom
and conscience, but nevertheless expressed concerns that absent the
provision's adoption of title IX's abortion neutrality provision,
health care providers and entities with religious objections would be
left without protections and would be forced to provide, cover, pay, or
refer for abortion services.
Response: OCR appreciates commenters' concerns, but for the reasons
stated above, we disagree. A covered entity does not engage in
discrimination prohibited by section 1557 if it declines to provide,
pay for, cover, or refer for abortions based on religious or conscience
objections to performing the procedure. OCR also intends to enforce and
comply with all applicable religious freedom and conscience
protections, including section 1303 of the ACA, the Weldon, Church, and
Coats-Snowe amendments, RFRA, and other applicable religious freedom
and conscience laws. We have added a procedure for recipients whereby
they may rely on such protections or seek assurance of those
protections, if they wish. See Sec. 92.302.
Comment: Other commenters who objected to the Department's position
contended that, on the one hand, OCR was relying on title IX's
regulations to prohibit discrimination on pregnancy-related conditions,
while, on the other hand, ignoring title IX's statutory abortion
neutrality provision and religious exception. These commenters argued
that OCR is arbitrarily and capriciously picking and choosing which
provisions of title IX to implement. They stated that, under title IX,
declining to provide or pay for any service related to abortion is not
treated as prohibited sex discrimination and therefore it cannot be
that the same action, under section 1557, could constitute prohibited
sex discrimination. Several commenters argued that the abortion
neutrality provision, unlike title IX's exceptions, is a rule of
construction that applies to all of title IX, including the statute's
prohibition on sex discrimination, and thus OCR must incorporate the
provision into any section 1557 implementing regulations.
Response: OCR appreciates commenters' concerns. As we explained
above, however, section 1557 incorporates some, but not all, parts of
title VI, title IX, the Age Act, and section 504. Specifically, section
1557 incorporates the ``ground'' of discrimination and the
``enforcement mechanisms'' under the referenced statutes, including
title IX. Section 1557 is best read to incorporate existing
interpretations of what constitutes sex discrimination under title IX,
including regulatory interpretations and case law.
[[Page 37639]]
But section 1557 does not incorporate provisions of title IX or that
statute's regulations that do not define or interpret what constitutes
a ground of discrimination or an enforcement mechanism. Those
provisions include the religious exception and the abortion neutrality
provision. This reading gives meaning to every term in section 1557,
while recognizing that although the statute incorporates parts of other
civil rights statutes, each statute addresses distinct issues and
contexts. Title IX's abortion neutrality provision is a rule of
construction as to what acts can be required of recipients under title
IX, but nothing in the provision states that it construes what
constitutes a ground of prohibited discrimination. In section 1557,
Congress was explicit in the limited incorporation of title IX when it
listed only the ground to be prohibited by itle IX and the enforcement
mechanisms that apply, and the title IX abortion neutrality provision
is not an enforcement mechanism.
Comment: Many commenters stated that OCR's proposal to not import
the title IX abortion neutrality provision is contrary to Congress's
intent when it drafted section 1557 and explicitly adopted by reference
the entire title IX scheme under 20 U.S.C. 1681 et seq. Commenters
stated that enactment of title IX did not simply prohibit sex
discrimination, because at least two categories of conduct are not, in
Congress's view, what constitutes sex discrimination for purposes of
title IX--religious decisions by an entity that conflict with the terms
of title IX and the refusal to provide or pay for abortion. In their
view, this means that OCR cannot prohibit discrimination based on
termination of pregnancy or abortion as a form of sex discrimination.
Response: OCR appreciates commenters' concerns but disagrees that
the manner in which Congress chose to cite title IX in section 1557
indicates an intent to limit what constitutes discrimination of the
basis of sex for the reasons stated above. OCR specifically disagrees
that the inclusion of ``et seq.'' indicates Congress's intent to
incorporate the entire statute, thereby negating Congress's use of the
terms ``ground prohibited'' and ``enforcement mechanisms'' when
describing which portions of title IX shall be incorporated in section
1557. Moreover, as discussed in detail above (see Treatment of the
Title IX Religious Exception), OCR's analysis considers the entire
statute, including title IX's specific limitation to the context of
educational programs and activities.
Comment: Commenters argued that title IX's adoption by reference
supports Congress's longstanding position to legislate in a manner that
remains neutral with respect to abortion. In support of this view, some
commenters pointed to the Pregnancy Discrimination Act of 1978, where
Congress prohibits discrimination on the basis of pregnancy,
childbirth, or related medical conditions, but also explicitly included
an exemption for health insurance benefits for abortion which, in their
view, demonstrates Congress's intent to remain neutral on abortion.
Response: OCR will adhere to the specific terms Congress enacted in
section 1557 as well as other applicable Federal laws, including
section 1303 of the ACA, the Weldon, Church, and Coats-Snowe
amendments, RFRA, and other applicable religious freedom and conscience
laws.
Comment: Other commenters who objected to OCR's proposal not to
import title IX's abortion neutrality provision in the rule expressed
concern that OCR ignored section 1303 of the ACA, 42 U.S.C. 18023,
which they opine requires abortion neutrality throughout the ACA. For
example, commenters discuss that section 1303(a), which gives States
the option to prohibit abortion coverage in health plans, would be
rendered meaningless if the final rule requires such coverage by either
prohibiting discrimination on the basis of pregnancy-related conditions
or by failing to include a provision establishing section 1557's
abortion neutrality. Commenters stated that section 1303 forecloses any
construction of section 1557 that would require the provision or
coverage of abortion.
Response: OCR appreciates commenters' concerns regarding section
1303's applicability to section 1557. Section 1303(a) provides that
States and qualified health plans may, to the extent allowed by State
law, opt to offer or prohibit abortion coverage; it does not require
that section 1557 to import the language of title IX's abortion
neutrality provision. Section 1303 primarily grants States flexibility
to decide whether qualified health plans sold through their respective
Exchanges can include coverage benefits for abortion services. See 42
U.S.C. 18023(a) (``State opt-out of abortion coverage''). And, unless
otherwise prohibited by State law, participating issuers may elect to
cover abortion services in qualified health plans. For qualified health
plans that elect to offer as a coverage benefit abortion services for
which Federal funding is prohibited, section 1303 establishes separate
accounting requirements to ensure Federal funds are segregated and
maintained separate from a policy holder's out-of-pocket funds, which
may pay for abortion coverage. 42 U.S.C. 18023(b)(2)(B)-(C). OCR
acknowledges that section 1303 allows qualified health plans the
independence to choose whether to provide abortion coverage where
consistent with State law, but it does not command that the final rule
import title IX's abortion neutrality provision.
OCR reiterates, moreover, that a covered provider's decision not to
provide abortions or abortion coverage does not itself constitute
discrimination in violation of section 1557. A covered entity that
generally offered abortion care could violate section 1557 if, for
example, it refused to provide an abortion to a particular patient
because of their race or disability. But a covered provider does not
engage in discrimination prohibited by section 1557 if it declines to
provide abortions based on religious or conscience objections to
performing the procedure, based on a professional or business judgment
about the scope of the services it wishes to offer, or for any other
nondiscriminatory reason. Further, OCR maintains that importing title
IX's abortion neutrality provision is not required given the
recognition of the ACA provisions on abortion and the inclusion of
those provisions in regulatory text.
Comment: Several commenters pointed to the Weldon and Church
Amendments to assert that OCR does not have the authority to prohibit
discrimination on the basis of pregnancy termination and requested that
OCR include title IX's abortion neutrality provision to avoid any
uncertainty on the issue. Other commenters urged OCR to include
affirmative language in the final rule that section 1557 does not
require the provision of, referral for, or coverage of abortion to
eliminate any uncertainty maintained by many religious providers.
Response: OCR remains committed to upholding the Federal laws,
including the abortion and conscience provisions of the ACA itself, the
Church, Coats-Snowe, and Weldon Amendments; the generally applicable
requirements of RFRA; and other applicable Federal laws that provide
protection to covered entities. It is not necessary to include title
IX's abortion neutrality provision in the final rule to provide
certainty as to the safeguards in place to protect religious freedom
and conscience. As discussed, a covered entity does not engage in
discrimination prohibited by section 1557 if it declines to provide
abortions based on religious or conscience objections to performing the
procedure. Also, we refer again to the process described at Sec.
92.302, whereby
[[Page 37640]]
providers may rely on the protections in Federal law for religious
freedom and conscience or seek assurance of such protections from OCR,
if they wish.
Comment: Many commenters who objected to OCR's proposal not to
import title IX's abortion neutrality provision in this rule expressed
concern regarding the Proposed Rule's discussion of EMTALA and
emergency medical conditions that may necessitate abortion. Some
commenters opined that the Proposed Rule's preamble was a potential
regulatory change by HHS to designate an ``abortion mandate'' in
EMTALA. Some commenters also noted that such an ``abortion mandate''
meant that HHS could preempt State laws that prohibit abortion or alter
State licensing and health and safety laws. Other commenters raised the
``major questions'' legal doctrine to conclude that Congress would not
have granted HHS the authority to promulgate such rules that would
rewrite the text of EMTALA on any grounds, including on the issue of
abortion.
Response: These comments fall outside the scope of the final rule.
To be clear, EMTALA does not alter any of section 1557's requirements,
and this rule does not alter existing obligations under EMTALA, or any
of the Department's previous guidance regarding EMTALA. Thus, nothing
about the final rule imposes any change to EMTALA's statutory scheme,
let alone a ``radical or fundamental change'' such that the major
questions doctrine is implicated.\314\ Further, commenters' view that
the ``major questions'' legal doctrine applies is also misplaced. The
``major questions'' doctrine applies in certain ``extraordinary cases''
in which courts will refuse to defer to agency action it considers
having ``vast economic and political significance'' absent express
authorization from Congress.\315\ As described, the final rule does not
alter any existing obligations or guidance as to EMTALA. The ``major
questions'' doctrine is not relevant here.
---------------------------------------------------------------------------
\314\ West Virginia v. EPA, 597 U.S. 697, 723 (2022).
\315\ West Virginia v. EPA, 597 U.S. at 716 (Invalidating the
Environmental Protection Agency's plan to require power plants to
shift from coal to renewables, reducing gross domestic product by at
least a trillion dollars within two decades); Nat'l Fed. of Indep.
Business v. OSHA, 142 S. Ct. 661, 665 (2022) (per curiam)
(Invalidating the Occupational Safety and Health Administration
order requiring ``84 million Americans to either obtain a COVID-19
vaccine or undergo weekly medical testing'').
---------------------------------------------------------------------------
Additionally, there is no basis for commenters' concerns about a
potential regulatory change or preemption of State laws, including
those involving licensing and health and safety. Per the ACA itself,
this rule does not override State laws regarding ``the prohibition of
(or requirement of) coverage, funding, or procedural requirements on
abortions'' or alter preexisting obligations under Federal law. See 42
U.S.C. 18023(c)(1), (d).
Comment: Other commenters stated that the Franciscan Alliance
opinion vacating provisions similarly related to pregnancy-related
conditions in the 2016 Rule precludes OCR from issuing this final rule
with similar provisions that do not import title IX's abortion
neutrality provision. Some commenters maintained that if OCR
promulgates this rule with similar provisions, OCR risks being held in
contempt of court. Other commenters stated that to adequately issue
this final rule, OCR must explain why the holdings of the Franciscan
Alliance court are incorrect or inapplicable to this rulemaking.
Response: OCR appreciates commenters' concerns, but notes that they
mischaracterize the impact of the relief ordered in Franciscan Alliance
on this rulemaking. The Franciscan Alliance court vacated a portion of
the 2016 Rule--namely its interpretation of sex discrimination to
include gender identity and termination of pregnancy.\316\ The court
also enjoined the Federal Government from interpreting or enforcing
section 1557 or any related implementing regulations against the
plaintiffs in that particular case in a manner that would require those
plaintiffs to perform or provide insurance coverage for gender-
transition procedures or abortions.\317\ The court's orders have no
effect on, and do not apply to, OCR's authority to promulgate new
regulations, including this final rule, and to enforce those
regulations against covered entities that were not plaintiffs in
Franciscan Alliance. The instant rulemaking is new and includes
significant changes that address concerns raised against the 2016 Rule
in Franciscan Alliance. Also notable is the fact that Sec. 92.302
outlines new procedures whereby persons may rely on the protections of
Federal conscience or religious freedom laws or choose to seek
assurance of such protections, if they wish. And OCR has issued a
separate final rule codifying safeguards for Federal conscience
protections. See 89 FR 2078 (Jan. 11, 2024). In addition, OCR has
considered the legal and factual developments since the issuance of the
2016 Rule, which help to inform its decisions in this final rule.
Therefore, OCR's promulgation of its new regulation in no way
contravenes the Franciscan Alliance court's orders, and OCR will comply
with that court's orders, and all other applicable orders, in enforcing
this final rule. OCR thus disagrees that issuing this rule puts the
agency at risk of being held in contempt, merely for acting within the
authority that has been lawfully delegated to HHS under section 1557.
---------------------------------------------------------------------------
\316\ Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928, 945-47
(N.D. Tex. 2019).
\317\ Franciscan All., Inc. v. Becerra, 553 F. Supp. 3d 361, 378
(N.D. Tex. 2021).
---------------------------------------------------------------------------
Comment: Some commenters requested that OCR provide clarification,
either in a final rule or via sub-regulatory guidance, as to how the
proposed pregnancy discrimination protections relate to and may be
different from those guaranteed by the Pregnancy Discrimination Act of
1978.
Response: OCR appreciates these commenters' request and is intent
on providing clear guidance on the scope of the final rule and its
application through educational outreach efforts, trainings, and
individualized assistance. OCR clarifies that it does not enforce the
Pregnancy Discrimination Act of 1978, Public Law 95-555, which amended
title VII, and applies to discrimination on the basis of pregnancy,
childbirth, or related medical conditions in employment settings, while
section 1557 applies to health programs or activities that receive
Federal financial assistance. We also note that section 1557, title IX,
and title VII are read consistently to apply similar protections in the
different contexts in which they apply.
Comment: Other commenters expressed concern that Dobbs created
tension between health care providers and patients, increasing distrust
in providers. Commenters also stated that Dobbs has created chaos in
the health care system, increasing the risk that patients will
experience discriminatory care and suffer delays in lifesaving
treatment as a direct result of legal and medical uncertainty. These
commenters said that discrimination in care propagates more distrust,
which is a significant barrier for individuals seeking care and is
precisely what section 1557 was designed to protect against.
Response: OCR appreciates the commenters' concerns. OCR understands
that the provider-patient relationship is critical to the provision of
quality, competent health care and critical for achieving optimal
health. For example, in proposing the policies and procedures required
under Sec. 92.8, OCR confirmed that patients value the ability to have
their concerns directly heard by
[[Page 37641]]
their provider,\318\ and understands that not all communities in the
United States feel the same level of trust in their health care
provider, particularly among racially and ethnically diverse
communities.\319\ OCR further recognizes that in light of Dobbs, in
certain States, a patient may fear sharing critical information
relevant to their health status. OCR is separately considering
revisions to the HIPAA Privacy Rule to strengthen privacy protections
for individuals' protected health information related to reproductive
health care, which will assist in generating more trusting patient-
provider relationships. See HIPAA Privacy Rule To Support Reproductive
Health Care Privacy, notice of proposed rulemaking, 88 FR 23506 (Apr.
17, 2023).
---------------------------------------------------------------------------
\318\ 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/us/en/insights/industry/health-care/trust-in-health-care-system.html.
\319\ Leslie Read et al., The Deloitte Ctr. for Health
Solutions, Rebuilding Trust in Health Care: What Do Consumers Want--
and Need--Organizations to Do? (2021); https://www2.deloitte.com/us/en/insights/industry/health-care/trust-in-health-care-system.html.
---------------------------------------------------------------------------
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.208, with modification. For clarity, we are finalizing by
adding a cross-reference to Sec. 92.101(a)(2)'s description of sex
discrimination.
Nondiscrimination on the Basis of Association (Sec. 92.209)
In Sec. 92.209, we proposed prohibiting 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 known to
have a relationship or association.
The comments and our responses regarding proposed Sec. 92.209 are
set forth below.
Comment: Commenters on this provision overwhelmingly expressed
support for the inclusion of an explicit prohibition on associational
discrimination, which many stated will protect individuals, including
children and elders, who associate with LGBTQI+ individuals. Other
commenters said that a prohibition of associational discrimination will
also protect individuals and families who associate with an individual
who has a history of drug use or substance use disorder (SUD). Some
commenters noted that the 2020 Rule repealed the 2016 Rule's
associational discrimination protections at former 45 CFR 92.209,
despite comments urging OCR to maintain the provision. Many commenters
noted that courts have recognized an individual's right to be free from
discrimination based on their association with another an individual
protected on one or more bases under section 1557.\320\
---------------------------------------------------------------------------
\320\ 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); Holcomb v. Iona Coll., 521 F.3d 130 (2nd Cir. 2008) (an
employee has a cognizable title VII claim against an employer who
takes an adverse action against the employee because of the
employee's association with a person of another race); Larimer v.
Int'l Bus. Machines Corp., 370 F.3d 698, 702 (7th Cir. 2004) (the
court affirmed lower court's summary judgment in favor of defendant
employer, in part, because plaintiff employee's employment claim did
not fit into any one of three recognized categories of associational
discrimination under the ADA); Loeffler v. Staten Island Univ.
Hosp., 582 F.3d 268, 279 (2d. Cir. 2009) (court permitted
associational discrimination claim brought by deaf father's children
who were forced to interpret for him in the hospital); Mx Grp., Inc.
v. City of Covington, 293 F.3d 326, 335 (6th Cir. 2002) (holding a
drug and alcohol treatment center that was wrongfully denied a
zoning permit because it provided services to individuals with
disabilities was subjected to discrimination under title II of the
ADA); Barrett v. Whirlpool Corp., 556 F.3d 502, 512 (6th Cir. 2009)
(title VII and sec. 1981 forbid employment discrimination on the
basis of association with or advocacy for a protected party); Tetro
v. Elliot Popham Pontiac, Oldsmobile, Buick, & GMC Trucks, Inc., 173
F.3d 988, 994-95 (6th Cir. 1999) (court reversed lower court's
dismissal of plaintiff's associational discrimination claim because
title VII prohibits such discrimination); Deffenbaugh-Williams v.
Wal-Mart Stores, Inc., 156 F.3d 581, 589 (5th Cir. 1998) (court
upheld jury's determination that employer wrongfully terminated
employee based on employee's association with a Black person)
vacated in part on other grounds by Williams v. Wal-Mart Stores,
Inc., 182 F.3d 333 (5th Cir. 1999) (en banc); Parr v. Woodmen of the
World Life Ins. Co., 791 F.2d 888, 892 (11th Cir. 1986) (trial court
erred in dismissing plaintiff's associational discrimination claim
because Sec. 1981 prohibits associational discrimination); Hively
v. Ivy Tech Cmty. Coll. of Ind., 853 F.3d 339, 345 (7th Cir. 2017)
(finding plaintiff had a case for sex discrimination in part based
on the gender and orientation of her partner); Zarda v. Altitude
Express, 883 F.3d 100, 124 (2d Cir. 2018), (court held that
prohibition of associational discrimination applies with equal force
to all the classes protected by title VII); Videckis v. Pepperdine
Univ., 150 F. Supp. 3d 1151, 1161 (C.D. Cal. 2015) (sexual
orientation discrimination is sex discrimination in part because it
involves treatment that was based on the sex of the person(s) with
whom the individual associates); Baldwin v. Foxx, 2015 WL 4397641
(EEOC July 15, 2015) (``Sexual orientation discrimination is also
sex discrimination because it is associational discrimination on the
basis of sex.''); Kauffman v. Maxim Healthcare Servs., Inc., No. 04-
CV-2869, 2006 WL 1983196, at *3 (E.D.N.Y. July 13, 2006) (``Although
Defendant correctly points out that the Second Circuit has not
recognized as valid causes of action third-party claims of
association discrimination or retaliation like those presented in
the instant case, there is nevertheless a wealth of support in the
prior decisions of the courts in this Circuit and our highest Court
for recognizing these types of claims.'').
---------------------------------------------------------------------------
Response: OCR agrees that it is important to include an explicit
provision addressing associational discrimination, as both consistent
with courts' interpretation of what constitutes discrimination as well
as to protect those experiencing such forms of discrimination.\321\ As
commenters noted, this particularly impacts LGBTQI+ people because
significant numbers of children and elders live with or are cared for
by LGBTQI+ people,\322\ and some providers have refused to provide
health care to children, for example, because their parents are gay or
lesbian.\323\ This is
[[Page 37642]]
likely also to be particularly important for people, especially
children, who cannot access health care without the support of a
caregiver. Such conduct by a covered entity may violate this provision
and other provisions of this part, including Sec. Sec. 92.101
(Discrimination prohibited), 92.206 (Equal program access on the basis
of sex), 92.207 (Nondiscrimination in health insurance coverage and
other health-related coverage), and 92.208 (Prohibition on sex
discrimination related to marital, parental, or family status).
Additionally, associational or caregiver discrimination also frequently
arises in the context of disability discrimination, as addressed above
in the preamble discussion of Sec. 92.202 (Effective communication for
individuals with disabilities). Another potential example of
discrimination based on association relates to individuals with a
substance use disorder (SUD) \324\ and related stigma.\325\ The ADA,
section 504, and section 1557 prohibit discrimination on the basis of
disability, and individuals with an SUD or a history of having an SUD
typically are protected under these authorities, unless they are
engaged in the current illegal use of drugs.\326\ Section 92.209 makes
clear that discrimination against individuals (including friends,
nonfamilial caregivers, and family members) based on their association
with individuals in recovery from SUD or with a history of drug use is
prohibited under section 1557.
---------------------------------------------------------------------------
\321\ See Kengerski v. Harper, 6 F.4th 531, 537-539 (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, 469-470 (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.''). Cf. Loving v. Va.,
388 U.S. 1 (1967).
\322\ Family Equality Council, LGBTQ Family Fact Sheet, https://www2.census.gov/cac/nac/meetings/2017-11/LGBTQ-families-factsheet.pdf, (as of 2017, between 2 and 3.7 million children in
the US have LGBTQ+ parents); Family Equality Council, LGBTQ Family
Building Survey (2019), https://www.familyequality.org/wp-content/uploads/2019/02/LGBTQ-Family-Building-Study_Jan2019-1.pdf (77
percent of LGBTQ+ millennials either are already parents or are
considering expanding their families in the years ahead); SAGE,
Caregiving in the LGBT Community (2017), https://www.lgbtagingcenter.org/resources/pdfs/SAGE%20Caregiver%20Guide%20Final%20Interactive.pdf (approximately 3
million LGBTQ+ people are the primary caregiver for someone over the
age of 50).
\323\ Tresa Baldas, Pediatrician Won't Treat Baby With 2 Moms,
USA Today (Feb. 18, 2015), https://www.usatoday.com/story/news/nation/2015/02/18/doctor-discrimination-baby/23642091/.
\324\ Substance Use Disorder Demographics, American Addiction
Centers, (Dec. 9, 2022), https://sunrisehouse.com/addiction-demographics (more than 40 million Americans aged 12 or older
suffered from a substance use disorder in 2020).
\325\ Janet Zwick et al., Stigma: How It Effects the Substance
Use Disorder Patient, 15 Substance Abuse Treatment, Prevention, &
Pol., (2020), https://link.springer.com/article/10.1186/s13011-020-00288-0 (Stigma serves as a barrier to individuals with SUD seeking
help, entering treatment, and accepting medications.).
\326\ See, e.g., U.S. Dep't of Justice, The ADA and Opioid Use
Disorder: Combatting Discrimination Against People in Treatment and
Recovery (Apr. 5, 2022), https://www.ada.gov/resources/opioid-use-disorder/.
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Comment: One commenter accurately observed that, unlike the
Proposed Rule, the 2016 Rule's associational nondiscrimination
provision referenced protections for both individuals and entities that
associate with others. Emphasizing that an entity can also be
discriminated against by other covered entities based on the original
entity's association with an individual due to the individual's race,
color, national origin, sex, disability or age, this commenter
described a scenario where a health plan might discriminate against an
entity that largely serves patients with LEP, LGBTQI+ populations, or
an entity that provides Medications for Opioid Use Disorder (MOUD) to
individuals with opioid use disorder.
Response: OCR recognizes that there may be instances where covered
entities may discriminate against other entities based on these other
entities' associations with populations they serve (including LGBTQI+
individuals, individuals with disabilities, etc.). For example, Sec.
92.209 prohibits a covered entity from discriminating against another
entity because that entity serves individuals protected under this
rule, e.g., individuals with SUD,\327\ people with intellectual and
developmental disabilities, people of a particular race or national
origin, or people of a particular age. In this case, Sec. 92.209 is
violated based on the discriminated-against entity's association with
an individual or individuals based on their race, color, national
origin, sex, age, or disability. OCR did not intend to suggest in the
Proposed Rule that this was no longer considered a prohibited form of
discrimination and therefore is including ``entity'' in the final rule
text.
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\327\ See MX Grp., Inc. v. City of Covington, 293 F.3d 326, 335
(6th Cir. 2002) (a public entity violated title II of the ADA when
it discriminated against a drug and alcohol treatment center by
denying it a zoning permit because the center provided services to
individuals with disabilities).
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.209, with modification. We have revised the provision to
clarify that covered entities are prohibited from discriminating
against individuals and entities under this provision by adding ``or
entity'' in the following locations: ``. . . against an individual or
entity . . .,'' and ``. . . with whom the individual or entity . . .
.''
Nondiscrimination in the Use of Patient Care Decision Support Tools
(Sec. 92.210)
Proposed Sec. 92.210, entitled ``Use of clinical algorithms in
decision-making,'' provided 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. We invited extensive public comment on this proposed
provision, including on whether to limit the provision to clinical
algorithms or to include additional forms of automated or augmented
decision-making tools or models, such as artificial intelligence (AI)
and machine learning, and whether the provision should include more
specificity, such as explaining actions covered entities must take to
identify and mitigate potential discrimination from these tools. 87 FR
47884. The Proposed Rule preamble described clinical algorithms as
``tools used to guide health care decision-making that could range in
form from flowcharts and clinical guidelines to complex computer
algorithms, decision support interventions, and models.'' 87 FR 47880.
The preamble also described clinical algorithms as tools used by
``hospitals, providers, and payers (e.g., health insurance issuers) . .
. to assist with health care decision-making for various purposes,''
including ``screening, risk prediction, diagnosis, prognosis, clinical
decision-making, treatment planning, health care operations, and
allocation of resources, all of which affect the care that individuals
receive.'' 87 FR 47880. The comments and our responses regarding Sec.
92.210 are set forth below.
Comment: Many commenters requested that OCR codify a definition for
the term ``clinical algorithm.'' Some commenters requested a definition
for ``clinical algorithm'' to include any form of automated decision
systems and AI used in health programs or activities. Many commenters
also recommended that Sec. 92.210 apply to tools used in a covered
entity's health programs and activities in addition to those used in a
clinical setting. These commenters suggested that Sec. 92.210 should
apply to a covered entity's administrative health care operations
because the use of these tools can impact individuals' access to a
covered entity's health programs and activities and the quality of
services provided.
Arguing that the term ``clinical algorithm'' is insufficient, some
commenters cited examples of tools that covered entities use in their
health programs and activities, such as those used for budgeting and
billing processes, utilization management, benefit design, program
eligibility and enrollment, provider contracting, and pricing by
providers and insurers which are susceptible to discriminatory bias.
Commenters also identified tools used in skilled nursing facilities,
tools used to allocate home and community-based services, and Medicaid
eligibility systems.
Response: In the Proposed Rule's preamble, we indicated that
``clinical algorithms'' include tools beyond actual algorithms, 87 FR
47880, and we solicited comment about whether ``clinical algorithms''
should ``include additional forms of automated or augmented decision-
making tools or models such as artificial intelligence or
[[Page 37643]]
machine learning,'' 87 FR 47884. The Proposed Rule described ``clinical
algorithms'' as ``tools used to guide health care decision-making that
can range in form from flowcharts and clinical guidelines to complex
computer algorithms, decision support interventions, and models,''
which hospitals, providers and health insurance issuers use to ``assist
with decision-making for various purposes,'' including ``screening,
risk prediction, diagnosis, prognosis, clinical decision-making,
treatment planning, health care operations, and allocation of
resources, all of which affect the care that individuals receive.'' 87
FR 47880 (emphases added). Thus, the Proposed Rule described clinical
algorithms broadly to include a variety of health care decision-making
tools in a covered entity's health programs and activities related to
patient care. We further solicited comment about ``what types of
clinical algorithms are being used in covered health programs and
activities; how such algorithms are being used by covered entities;
[and] whether they are more prevalent in certain health settings . . .
.'' 87 FR 47884.
As discussed in the preamble under Sec. 92.4, we are adopting the
more precise term ``patient care decision support tool'' to replace the
term ``clinical algorithm.'' This new term more closely aligns with
what we described as ``clinical algorithms'' in the preamble to the
Proposed Rule, such as various tools used to guide health care
decision-making that affect the care that patients receive. See 87 FR
47880. In Sec. 92.4, we define ``patient care decision support tool''
to mean ``any automated or non-automated tool, mechanism, method,
technology, or combination thereof used by a covered entity to support
clinical decision-making in its health programs or activities.'' The
definition applies to tools that are used by a covered entity in its
clinical decision-making that affect the patient care that individuals
receive. Given covered entities' widespread use of automated decision
systems and AI, and the scale by which AI can influence covered
entities' clinical decision-making,\328\ we are confirming that the
types of patient care decision support tools subject to Sec. 92.210
include automated decision systems and AI used to support clinical
decision-making.
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\328\ Nat'l Acad. of Med., Artificial Intelligence in Health
Care: The Hope, the Hype, the Promise, the Peril, pp. 2, 3 (2019),
https://doi.org/10.17226/27111; Nat'l Inst. of Standards & Tech.,
Artificial Intelligence Risk Management Framework (AI RMF 1.0), NIST
AI 100-1, pp. 1, 17, 40 (2023), https://doi.org/10.6028/NIST.AI.100-1.
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Covered entities may use patient care decision support tools in
their health care decision-making in a variety of ways. Covered
entities typically use patient care decision support tools at the
individual patient level, such as a provider using clinical guidance
from an algorithm to assess a patient's risk of a severe cardiac
event.\329\ Other patient care decision support tools pertain to health
care administration decisions, typically used with regard to a group of
patients (or a population) based on shared characteristics. For
example, there is evidence that hospital system treatment protocol
varies by geographic area due to variations produced by risk adjustment
modeling.\330\ In addition to these examples, patient care decision
support tools would also include tools used for prior authorization and
medical necessity analysis,\331\ which directly impacts clinical
decision-making and affects the care received by patients as directed
by their providers. For example, a medical necessity review tool used
by Medicare Advantage plans has been shown to deny enrollees' medical
claims for rehabilitative care without considering enrollees'
individual circumstances.\332\
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\329\ 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).
\330\ Elliott Fisher et al., Health Care Spending, Quality, and
Outcomes--More Isn't Always Better, The Dartmouth Inst. for Health
Pol. & Clinical Practice (2009), https://www.ncbi.nlm.nih.gov/books/n/darthhcspending/pdf/; Ziad Obermeyer et al., Dissecting Racial
Bias in an Algorithm Used to Manage the Health of Populations, 366
Science 447 (2019), https://www.science.org/doi/10.1126/science.aax2342.
\331\ See, e.g., Casey Ross & Bob Herman, UnitedHealth Pushed
Employees to Follow an Algorithm to Cut Off Medicare Patients' Rehab
Care, STAT News (Nov. 14, 2023), https://www.statnews.com/2023/11/14/unitedhealth-algorithm-medicare-advantage-investigation/; Patrick
Rucker et al., How Cigna Saves Millions by Having Its Doctors Reject
Claims Without Reading Them, ProPublica (March 25, 2023), https://www.propublica.org/article/cigna-pxdx-medical-health-insurance-rejection-claims; Casey Ross & Bob Herman, Denied by AI: How
Medicare Advantage Plans Use Algorithms to Cut Off Care for Seniors
in Need, STAT News, (Mar. 13, 2023) https://www.statnews.com/2023/03/13/medicare-advantage-plans-denial-artificial-intelligence/;
Shahed Al-Haque et al., AI Ushers in Next-Gen Prior Authorization in
Healthcare, McKinsey & Co. (Apr. 19, 2022), https://www.mckinsey.com/industries/healthcare/our-insights/ai-ushers-in-next-gen-prior-authorization-in-healthcare#/.
\332\ See, e.g., Casey Ross & Bob Herman, Denied by AI: How
Medicare Advantage Plans Use Algorithms to Cut Off Care for Seniors
in Need, STAT News, https://www.statnews.com/2023/03/13/medicare-advantage-plans-denial-artificial-intelligence/ (Mar. 13, 2023).
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One subset of patient care decision support tools to which Sec.
92.210 applies includes ``predictive decision support interventions''
as defined in the Office of the National Coordinator for Health
Information Technology's (ONC) recently published final rule for
``Health Data, Technology, and Interoperability: Certification Program
Updates, Algorithm Transparency, and Information Sharing.'' \333\ In
its rule, ONC defines the term ``predictive decision support
intervention'' (Predictive DSI) to mean ``technology that supports
decision-making based on algorithms or models that derive relationships
from training data and then produce an output that results in
prediction, classification, recommendation, evaluation, or analysis.''
89 FR 1192 (codified at 45 CFR 170.102). As ONC discussed in the
Proposed Rule, Predictive DSI are used to predict unknown values based
on relationships learned in training data, and they pertain to
automated tools used for clinical, financial, or administrative
purposes. ``Health Data, Technology, and Interoperability:
Certification Program Updates, Algorithm Transparency, and Information
Sharing.'' 88 FR 23746, 23785 (April 18, 2023).
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\333\ 45 CFR 170.102; U.S. Dep't of Health & Hum. Servs., Off.
of the Nat'l Coordinator for Health Info. Tech., Health Data,
Technology, and Interoperability: Certification Program Updates,
Algorithm Transparency, and Information Sharing, Final Rule, 89 FR
1192 (January 9, 2024). Regarding the term ``intervention,'' ONC
notes that the term ``intervention'' in ``prediction decision
support intervention'' was not intended to mean an intervention
(medicine, medical procedure, or medical treatment) as the term is
used in the practice of medicine, but rather, an intervention
occurring within a workstream, including but not limited to alerts,
order sets, flowsheets, dashboards, patient lists, documentation
forms, relevant data presentations, protocol or pathway support,
reference information or guidance, and reminder messages. Their use
of the term intervention was consistent with how the Program used
the term in Sec. 170.315(a)(9).
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It is important to note that Sec. 92.210 is not duplicative of
ONC's rule regarding Predictive DSIs because ONC's rule applies to and
includes requirements for health information technology (IT)
developers, whereas Sec. 92.210 applies to and includes requirements
for section 1557 covered entity users of patient care decision support
tools (including Predictive DSIs). A section 1557 covered entity may,
of course, develop its own Predictive DSI, in which case that entity
may be subject to ONC's Predictive DSI requirements as well as section
1557's nondiscrimination requirements under Sec. 92.210. Refer to
section V of ONC's January 2024 Final Rule, 89 FR 1242-54, for more
detailed information regarding Predictive DSIs. OCR worked closely with
ONC during the development of this final rule and ONC's rule to advance
a coordinated Departmental response in regulating
[[Page 37644]]
tools used to support health care decision-making.
Section 92.210's definition for ``patient care decision support
tool'' also includes non-automated and evidence-based tools that rely
on rules, assumptions, constraints, or thresholds, as these also have
the potential to result in discrimination. This includes ``evidence-
based decision support interventions'' identified in ONC regulations at
45 CFR 170.315(b)(11)(iii). An example of a non-automated patient care
decision support tool is a Crisis Standards of Care \334\ flowchart for
triage guidance. Such a flowchart may result in discrimination if, for
example, it screens out individuals with disabilities, prohibiting them
from equally accessing a health care service, program, or activity that
a covered entity offers by assessing an individual's potential response
to life-saving care without making an individualized assessment of the
individual's health and without providing modifications for how an
individual's disability or age could affect the assessment factors used
in the algorithm or the time needed for the individual to respond to
treatment. Another example is the race-adjusted estimated glomerular
filtration rate (eGFR) equation that relies not only on training data,
but also discriminatory assumptions and thresholds such as by applying
a race-adjusted coefficient to the eGFR equation to reflect that Black
people have been associated with higher levels of blood creatinine as
compared with that of non-Black people, which results in a higher
significance threshold for Black patients, thereby requiring more
advanced kidney failure for Black patients than non-Black patients
before they can receive the same level of care. Other examples of
patient care decision support tools include, but are not limited to:
flowcharts; formulas; equations; calculators; algorithms; utilization
management applications; software as medical devices (SaMDs); software
in medical devices (SiMDs); screening, risk assessment, and eligibility
tools; and diagnostic and treatment guidance tools.
---------------------------------------------------------------------------
\334\ Crisis Standards of Care inform decision-making designed
to accomplish the best outcome for a group of patients rather than
focusing on an individual patient.
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Comment: Some commenters urged OCR to narrow the definition for
``clinical algorithm'' and to clarify that the scope of Sec. 92.210
does not extend beyond flowcharts and clinical algorithms to any forms
of automated decision systems or AI. These commenters contended that a
narrow definition is necessary to limit covered entities' liability and
burden, disruption to covered entities' decision-making, and patients'
exposure to greater health risks.
Response: Section 92.210 does not apply to tools used to support
decision-making unrelated to clinical decision-making affecting patient
care or that are outside of a covered entity's health programs or
activities. For example, Sec. 92.210 does not apply to the following
activities when such activities are unrelated to clinical decision-
making affecting patient care: automated or non-automated tools that
covered entities use for administrative and billing-related activities;
automated medical coding; fraud, waste and abuse; patient scheduling;
facilities management; inventory and materials management; supply chain
management; financial market investment management; or employment and
staffing-related activities.
The purpose of Sec. 92.210 is to prohibit discrimination that
occurs through covered entities' use of patient care decision support
tools in their health programs or activities. The rule does not seek to
disrupt covered entities' clinical decision-making, expose patients to
greater health risks, or to prevent the use of these tools entirely. We
encourage covered entities to continue procuring, developing, and using
patient care decision support tools that will improve patient care and
access to quality care. Section 92.210 will help covered entities use
these tools in a nondiscriminatory manner. Under Sec. 92.210,
evidence-based researchers, whose findings inform many inputs to
patient care decision support tools, will be incentivized to
recalibrate data, assumptions, and methods used in earlier studies.
Comment: Many commenters expressed support for proposed Sec.
92.210 and discussed the extent of discrimination in health care
resulting from the use of algorithms. Commenters were particularly
concerned about the prevalence of ethnic and racial bias in clinical
algorithms that results in fewer health care services provided to
Black, Hispanic/Latino, Asian, and American Indian/Alaska Native
patients. Others discussed Crisis Standards of Care, stating they are
too often biased against people with disabilities, people of color (who
disproportionately have at least one disability), and older individuals
because these tools assess an individual's potential response to life-
saving care without making an individualized assessment of the
individual's health and without providing modifications for how an
individual's disability or age could affect the assessment factors used
in the algorithm or the time needed for the individual to respond to
treatment.
Response: OCR appreciates commenters' feedback regarding proposed
Sec. 92.210. We share commenters' concerns about the potential for
discrimination caused by the use of algorithms in health care, which
are receiving considerable attention from the Department and
Administration,\335\ other executive agencies, Congress, stakeholders,
professional associations, medical journals, and the media. As OCR
implements section 1557 and other civil rights laws, it will continue
to consider additional actions to support covered entities in
implementation and compliance consistent with Federal law, including
guidance or provision of technical assistance.
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\335\ See, e.g., U.S. Dep't of Health & Hum. Servs., HHS
Finalizes Rule to Advance Health IT Interoperability and Algorithm
Transparency (2023), https://www.hhs.gov/about/news/2023/12/13/hhs-finalizes-rule-to-advance-health-it-interoperability-and-algorithm-transparency.html; U.S. Dep't of Health & Hum. Servs., Guiding
Principles Help Healthcare Community Address Potential Bias
Resulting from Algorithms (2023), https://www.hhs.gov/about/news/2023/12/15/guiding-principles-help-healthcare-community-address-potential-bias-resulting-from-algorithms.html; U.S. Dep't of Health
& Hum. Servs., Delivering on the Promise of AI to Improve Health
Outcomes (2023), https://www.whitehouse.gov/briefing-room/blog/2023/12/14/delivering-on-the-promise-of-ai-to-improve-health-outcomes/;
U.S. Dep't of Health & Hum. Servs., FACT SHEET: Biden-Harris
Administration Announces Voluntary Commitments from Leading
Healthcare Companies to Harness the Potential and Manage the Risks
Posed by AI (2023), https://www.hhs.gov/about/news/2023/12/14/fact-sheet-biden-harris-administration-announces-voluntary-commitments-leading-healthcare-companies-harness-potential-manage-risks-posed-ai.html.
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We particularly note that, since publication of proposed Sec.
92.210, the Administration has issued: (1) a Blueprint for an AI Bill
of Rights, which includes a principle for protecting the public from
algorithmic discrimination; \336\ (2) E.O. 14091, Further Advancing
Racial Equity and Support for Underserved Communities Through the
Federal Government, which includes a section requiring agencies to
consider opportunities to ``prevent and remedy discrimination,
including by protecting the public from algorithmic discrimination;''
\337\ and (3) E.O. 14110, Safe, Secure, and Trustworthy Development and
Use of Artificial Intelligence, which sets forth
[[Page 37645]]
numerous executive actions designed to ensure the equitable, safe, and
secure use of AI.\338\ E.O. 14110 addresses civil rights violations and
discrimination related to AI and seeks to protect individuals' civil
rights by preventing discrimination, including algorithmic
discrimination, through the use of automated systems and AI.\339\
---------------------------------------------------------------------------
\336\ The White House, Blueprint for an AI Bill of Rights (Oct.
4, 2022), https://www.whitehouse.gov/ostp/ai-bill-of-rights/.
\337\ E.O. 14091, sec. 8(f), 88 FR 10825, 10831 (Feb. 22, 2023),
https://www.federalregister.gov/documents/2023/02/22/2023-03779/further-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal.
\338\ E.O. 14110, 88 FR 75191 (Nov. 1, 2023).
\339\ E.O. 14110, sec. 7, 88 FR 75191, 75211 (Nov. 1, 2023).
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Executive Order 14110 directs the Department to take actions,
``possibly including regulatory action,'' to ``ensure the safe,
responsible deployment and use of AI in the healthcare, public-health,
and human-services sectors.'' \340\ It also directs the Department to
``consider appropriate actions to advance the prompt understanding of,
and compliance with, Federal nondiscrimination laws by health and human
services providers that receive Federal financial assistance, as well
as how those laws relate to AI.'' \341\
---------------------------------------------------------------------------
\340\ E.O. 14110, sec. 8(b)(i), 88 FR 75191, 75214 (Nov. 1,
2023).
\341\ E.O. 14110, sec. 8(b)(iii), 88 FR 75191, 75214 (Nov. 1,
2023).
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We also acknowledge the recent surge in academic research
highlighting potential harms caused by use of patient care decision
support tools that may create or contribute to discrimination
prohibited by section 1557, as discussed in the Proposed Rule at 87 FR
47880-82.
We appreciate the comments addressing the potential bias in Crisis
Standards of Care, which, as discussed at length in the Proposed Rule,
87 FR 47881-82, were the focus of OCR's enforcement efforts during the
COVID-19 Public Health Emergency and resulted in six States revising
their Crisis Standards of Care to prevent discriminatory prioritization
of hospital resources.\342\
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\342\ For more information on OCR's work related to
discrimination in Crisis Standards of Care, see Civil Rights and
COVID-19, Non-Discrimination in Crisis Standards of Care, U.S. Dep't
of Health & Hum. Servs., Off. for Civil Rts., https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html.
---------------------------------------------------------------------------
Comment: Some commenters opposed proposed Sec. 92.210, in part,
because existing laws and regulations already prohibit discrimination
in algorithmic tools. Other commenters opposed to finalizing Sec.
92.210 urged OCR to use the feedback we received during the public
comment period to inform engagement with stakeholders, including the
Food and Drug Administration (FDA), device manufacturers, algorithm
developers, clinicians, patients, and others, through which OCR could
develop a regulatory framework involving risk-based approaches.
Response: While several Federal departments and agencies are taking
action to regulate AI and other decision-making tools,\343\ OCR,
consistent with its underlying authority, is in a unique position to
provide additional specificity regarding the application of long-
standing nondiscrimination requirements to the use of such tools to
ensure that discrimination does not result from covered entities' use
of patient care decision support tools in their health programs or
activities. The Department has authority to enforce section 1557, which
prohibits covered entities from discriminating in their health programs
and activities, including through the use of AI and other tools.
Section 92.210 provides additional clarity to covered entities
regarding their obligations. We are finalizing Sec. 92.210 with a
delayed applicability date of no later than 300 days after the final
rule's effective date to give covered entities a reasonable period of
time to come into compliance with Sec. 92.210(b) and (c).
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\343\ See, e.g., Proposed Rule at 87 FR 47882-84, n.569, 571,
578; U.S. Dep't of Health & Hum. Servs., Ctrs. for Medicare &
Medicaid Servs., Medicare Program; Contract Year 2024 Policy and
Technical Changes to the Medicare Advantage Program, Medicare
Prescription Drug Benefit Program, Medicare Cost Plan Program, and
Programs of All-Inclusive Care for the Elderly, Final Rule, 88 FR
22120, 22195 (Apr. 12, 2023), https://www.govinfo.gov/content/pkg/FR-2023-04-12/pdf/2023-07115.pdf (``MA organizations must ensure
that they are making medical necessity determinations based on the
circumstances of the specific individual, as outlined at Sec.
422.101(c), as opposed to using an algorithm or software that
doesn't account for an individual's circumstances.''); U.S. Dep't of
Health & Hum. Servs., Ctrs. for Medicare & Medicaid Servs., Medicare
Program: Hospital Outpatient Prospective Payment and Ambulatory
Surgical Center Payment Systems and Quality Reporting Programs;
Organ Acquisition; Rural Emergency Hospitals: Payment Policies,
Conditions of Participation, Provider Enrollment, Physician Self-
Referral; New Service Category for Hospital Outpatient Department
Prior Authorization Process; Overall Hospital Quality Star Rating;
COVID-19, Final Rule, 87 FR 71748, 72036 (Nov. 23, 2022), https://www.federalregister.gov/documents/2022/11/23/2022-23918/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment (responding to comment solicitation on how
to prevent and mitigate bias in algorithms and predictive modeling);
U.S. Dep't of Health & Hum. Servs., Food & Drug Admin., Artificial
Intelligence/Machine Learning (AI/ML)-Based Software as a Medical
Device (SaMD) Action Plan (2021), https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device; U.S. Dep't of Health &
Hum. Servs., Off. of the Nat'l Coordinator for Health Info. Tech.,
Health Data, Technology, and Interoperability: Certification Program
Updates, Algorithm Transparency, and Information Sharing, Final
Rule, 89 FR 1192 (January 9, 2024); Consumer Fin. Protection Bureau,
U.S. Dep't of Justice, U.S. Equal Employment Opportunity Comm'n, &
Fed. Trade Comm'n, Joint Statement on Enforcement Efforts Against
Discrimination and Bias in Automated Systems (Apr. 2023), https://files.consumerfinance.gov/f/documents/cfpb_joint-statement-enforcement-against-discrimination-bias-automated-systems_2023-04.pdf; Fed. Deposit Ins. Corp., Request for Information and Comment
on Financial Institutions' Use of Artificial Intelligence, Including
Machine Learning, 86 FR 16837-38 (May 24, 2021), https://www.govinfo.gov/content/pkg/FR-2021-05-24/pdf/2021-10861.pdf; Nat'l
Inst. of Standards & Tech., Artificial Intelligence Risk Management
Framework (AI RMF 1.0), NIST AI 100-1 (2023), https://doi.org/10.6028/NIST.AI.100-1.
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We received significant input on this issue from stakeholders
during the public comment period, and the breadth of stakeholders'
input and available research has informed the revisions in the final
version of Sec. 92.210. As OCR implements section 1557 and other civil
rights laws, it will continue to consider additional actions to support
covered entities in implementation and compliance consistent with
Federal law, including guidance or engaging in future rulemaking. As
AI, clinical algorithms, and predictive analytics are more widely used,
OCR will continue to engage with the FDA, ONC, and other Federal
partners to ensure consistency and a coordinated governmental effort to
regulate such tools in health care. We will also continue to solicit
stakeholders' input and to assist covered entities with compliance.
Comment: Some commenters expressed concern that proposed Sec.
92.210 would not apply to health care-related AI products that are
autonomous or that augment a covered entity's decision-making in its
health programs and activities.
Response: This final rule clarifies that Sec. 92.210 applies to
all patient care decision support tools used in a covered entity's
health programs or activities to support clinical decision-making,
including patient care decision support tools that are autonomous and
those that assist or augment a covered entity's clinical decision-
making.
Comment: Some commenters recommended that Sec. 92.210 exclude
tools designed to improve health equity because these tools serve to
protect members of historically marginalized communities. Relatedly,
one commenter asked how proposed Sec. 92.210 would affect algorithms
that are currently in use and specifically designed to identify certain
groups of patients susceptible to a particular condition or that may
benefit from a particular therapy.
Response: Section 92.210 does not prohibit covered entities from
using patient care decision support tools that identify, evaluate, and
address health disparities so long as their use does not constitute
prohibited discrimination on
[[Page 37646]]
the basis of race, color, national origin, sex, age, or disability.
Comment: Many commenters requested that OCR revise Sec. 92.210 to
include transparency requirements for covered entities regarding their
use of clinical algorithms in their health programs and activities,
including a requirement that covered entities notify individuals about
the training data, assumptions, constraints, thresholds, and other
inputs used to design each clinical algorithm in use. Commenters noted
that otherwise, individuals would not know whether there has been a
violation of Sec. 92.210.
Response: A covered entity may routinely change the patient care
decision support tools it uses. While there may be benefits to
providing such information to patients, we decline to revise Sec.
92.210 to require covered entities to notify patients about the patient
care decision support tools used in their health programs and
activities given the possible frequent changes and the costs associated
with notifying patients.
We similarly decline to revise Sec. 92.210 to require covered
entities to notify patients about the training data and other inputs
used to design and develop the patient care decision support tools used
by a covered entity because, in addition to the costs discussed above,
currently, patient care decision support tool developers may not
ordinarily share this information with covered entities. We note,
however, that ONC's final rule requires decision support interventions,
supplied by a developer of certified health IT as part of its Health IT
Module certified to 45 CFR 170.315(b)(11) criterion, to support making
this information (source attributes) available to users of the Health
IT Module. In addition, developers of certified health IT certified to
45 CFR 170.315(b)(11)(iii)(B) are required to make summary information
of intervention risk management practices publicly available for
Predictive DSIs the developer supplies as part of its Health IT Module
provided through 45 CFR 170.523(f)(1)(xxi). 89 FR 1192 (January 9,
2024). Covered entities using decision support interventions supplied
by a developer of certified health IT should have this type of
information available to them.
In addition, to the extent that covered entities subject to HIPAA
document their use of a patient care decision support tool in an
individual's medical record, individuals may obtain that information
when they exercise their HIPAA right of access to their protected
health information contained in their respective designated record
sets. See 45 CFR 164.524. Other Departmental agencies may also issue
transparency-related guidance and requirements for AI developers. OCR
seeks to partner with other agencies and covered entities to address
best practices and may release guidance in the future.
While we decline to impose transparency requirements under Sec.
92.210 for the reasons stated above, we note that it would be a best
practice for covered entities to disclose information to patients about
the patient care decision support tools used in their health programs
and activities.\344\ We further note, however, that such voluntary
disclosure does not ensure compliance with Sec. 92.210.
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\344\ See, e.g., Am. Med. Ass'n, American Medical Association
Principles for Augmented Intelligence Development, Deployment, and
Use, pp. 2-4 (2023), https://www.ama-assn.org/system/files/ama-ai-principles.pdf.
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Comment: Many commenters recommended that OCR revise Sec. 92.210
to clarify the steps that a covered entity must take to comply with
Sec. 92.210 and to ensure nondiscriminatory use of clinical
algorithms. Commenters explained that when providers use a patient care
support tool, they often rely on a developer's intended uses for the
tool. Commenters discussed that covered entities do not design or
develop many of the clinical algorithms that they use and are therefore
unlikely to be aware of how the tool operates. They also stated that it
is infeasible to require a covered entity to audit all algorithms in
its health programs or activities and that proposed Sec. 92.210 would
force covered entities to police their own supply chains for clinical
algorithms, which they state is also impracticable. Commenters
expressed concern that covered entities may incur liability when they
are unaware that an algorithmic output may result in discrimination and
opined that covered entities should not be liable in such cases.
Another commenter specified that physician liability should be limited
to when a reasonable physician knows or should have known that the
algorithm in question utilizes inputs and logic that are likely to
result in discrimination. Further, commenters asserted that the
additional steps that covered entities would need to take to comply
with proposed Sec. 92.210 are very likely to contribute to providers'
already strained workload and further contribute to burnout.
Response: We appreciate commenters' concerns and have revised Sec.
92.210 to provide additional clarity. We have added additional
clarification on covered entities' obligations under Sec. 92.210.
Section 92.210 sets forth the general prohibition on discrimination on
the basis of race, color, national origin, sex, age, or disability by a
covered entity in its health programs or activities through the use of
patient care decision support tools. Section 92.210(b) requires a
covered entity to make reasonable efforts to identify patient care
decision support tools used in its health programs and activities that
employ input variables or factors that measure race, color, national
origin, sex, age, or disability. Section 92.210(c) requires that for
each patient care decision support tool identified in paragraph (b), a
covered entity must make reasonable efforts to mitigate the risk of
discrimination resulting from the tool's use in its health programs or
activities.
We appreciate comments regarding how a covered entity may learn
that a patient care decision support tool used in its health programs
or activities creates a risk of discrimination on a protected basis. In
the Proposed Rule, we noted that use of clinical algorithms may result
in discriminatory outcomes when variables are used as a proxy for a
protected basis, and that discrimination may result from correlations
between a variable and a protected basis. 87 FR 47881. As a threshold
matter, we note that section 1557 prohibits proxy discrimination as a
general civil rights principle that applies to the entire final
rule.\345\ However, given the many possible indirect measures of race,
color, national origin, sex, age, and disability, covered entities are
not required to identify all patient care decision support tools with
input variables or factors that indirectly measure these protected
bases. However, covered entities should exercise caution when using
patient care decision support tools that are known to use indirect
measures for race, color, national origin, sex, age, or disability,
which could result in prohibited discrimination.
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\345\ See discussion of proxy discrimination at Sec. 92.207.
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We understand that covered entities in some circumstances may be
largely unaware of the datasets developers use to train the patient
care decision support tools that covered entities use. Section 92.210
does not require covered entities to obtain datasets or other attribute
information from developers when purchasing or using patient care
decision support tools. However, if a covered entity does not know
whether a developer's patient care decision support tool uses variables
or factors that measure race, color, national origin,
[[Page 37647]]
sex, age, or disability but has reason to believe such variables or
factors are being used, or the covered entity otherwise knows or should
know that the tool could result in discrimination, the covered entity
should consult publicly available sources or request this information
from the developer.
Further, ONC's recently published final rule discussed above
revises existing certification criteria for developers of certified
health IT by requiring developers with Health IT Modules certified to
Sec. 170.315(b)(11) to disclose information about a decision support
intervention's source attributes relevant to health equity with the
decision support intervention users. 89 FR 1192. This disclosure
requirement will work in tandem with Sec. 92.210 by enabling a covered
entity that uses Health IT Modules certified to Sec. 170.315(b)(11) to
learn from a developer whether a specific decision support intervention
relies on attributes that measure race, color, national origin, sex,
age, or disability.
We are aware that covered entities use patient care decision
support tools based on their respective needs and in accordance with
developers' intended uses. But covered entities must exercise due
diligence when acquiring and using such tools to ensure compliance with
Sec. 92.210.
Covered entities may learn that use of patient care decision
support tools risk resulting in discrimination when OCR included that
information in the Proposed Rule. In the Proposed Rule, in addition to
the use of the race-adjusted eGFR equation discussed above, we
identified uses of other categories of tools that may result in
discrimination based on race, including tools used in ``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).'' 87 FR 47881. The Proposed Rule also identified that
use of Crisis Standards of Care to allocate health care resources may
also discriminate on the basis of disability and/or age. 87 FR 47880-
82. OCR aims to continue providing additional guidance to the public
and covered entities as such information on potential discrimination in
the use of such tools becomes available.
The Department itself regularly publishes information and
advisories to the public. For example, the Agency for Healthcare
Research and Quality (AHRQ) recently issued a report on the ``Impact of
Healthcare Algorithms on Racial and Ethnic Disparities in Health and
Healthcare.'' \346\ Additionally, addressing published medical
journals' research studies and the subsequent media attention about
racial bias resulting from the use of pulse oximeters, the FDA
published a safety communication to announce that the FDA was
reassessing the content of its pulse oximetry guidance document and
would share additional updates with the public.\347\
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\346\ Kelley Tipton et al., U.S. Dep't of Health & Hum. Servs.,
Agency for Healthcare Rsch. & Quality, Impact of Healthcare
Algorithms on Racial and Ethnic Disparities in Health and
Healthcare, Comparative Effectiveness Review No. 268, AHRQ
Publication No. 24-EHC004 (2023), https://effectivehealthcare.ahrq.gov/sites/default/files/related_files/cer-268-racial-disparities-health-healthcare.pdf.
\347\ U.S. Dep't of Health & Hum. Servs., Food & Drug Admin.,
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication,
https://public4.pagefreezer.com/content/FDA/20-02-2024T15:13/https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication.
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Published articles of research studies in peer-reviewed medical
journals are also a reliable source of information about evidence-based
adverse outcomes based on patient care decision support tools that may
result in discrimination. Such articles are increasing in prevalence
given the growing use of AI and other patient care decision support
tools in health care decision-making.\348\ For example, peer-reviewed
medical journals have recently published several articles related to
racial discrepancies resulting from the use of pulse oximeters.\349\
One such study found that pulse oximeters more commonly overestimated
arterial oxygen saturation levels in patients from minority racial and
ethnic groups and led to delayed recognition of need for COVID-19
therapy among Black patients compared with white patients.\350\
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\348\ See, e.g., Armando D. Bedoya et al., A Framework for the
Oversight and Local Deployment of Safe and High-Quality Prediction
Models, 29 J. of Am. Med. Informatics Ass'n. 9, 1631-1636 (2022),
https://doi.org/10.1093/jamia/ocac078 (describing a governance
framework that combines current regulatory best practices and
lifecycle management of predictive models being used for clinical
care and maintaining a governance portfolio where models are
actively added); Shyam Visweswaran et al., Clinical Algorithms with
Race: An Online Database, medRxiv [Preprint], doi: 10.1101/
2023.07.04.23292231 (2023), https://pubmed.ncbi.nlm.nih.gov/
37461462/#:~:text=These%20clinical%20algorithms%20based%20on,the%20in
appropriate%20use%20of%20race (conducting a comprehensive search of
online resources, the scientific literature, and the FDA Drug Label
Information to identify clinical algorithms that incorporate race or
ethnicity as an input variable or predictor in determining
diagnoses, prognoses, treatment plans, or risk assessments; finding
39 race-based risk calculators, 6 laboratory test results with race-
based reference ranges, 1 race-based therapy recommendation, and 15
medications with race-based recommendations; and creating a current
and open-access database to track race-based clinical algorithms).
\349\ See, e.g., Ashraf Fawzy et al., Racial and Ethnic
Discrepancy in Pulse Oximetry and Delayed Identification of
Treatment Eligibility Among Patients with COVID-19, 182 JAMA
Internal Med. 730 (2022), https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2792653; Valeria S.Valbuena et al.,
Racial and Ethnic Bias in Pulse Oximetry and Clinical Outcomes, 182
JAMA Internal Med. 699 (2022), https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2792654; Michael W. Sjoding et al.,
Racial Bias in Pulse Oximetry Measurement, 383 New Eng. J. Med. 2477
(2020) https://www.nejm.org/doi/full/10.1056/nejmc2029240.
\350\ Ashraf Fawzy et al., Racial and Ethnic Discrepancy in
Pulse Oximetry and Delayed Identification of Treatment Eligibility
Among Patients with COVID-19, 182 JAMA Internal Med. 730 (2022),
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2792653.
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Covered entities also may gain knowledge that use of a patient care
decision support tool creates a risk of discrimination based on a
prohibited basis through media outlets that may report on reliable
studies.\351\
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\351\ Following medical journals' publication of research
articles related to racial bias through the use of pulse oximeters,
several media outlets amplified those findings further to the
public. See, e.g., Anil Onza et al., COVID-19 Made Pulse Oximeters
Ubiquitous. Engineers are Fixing Their Racial Bias, (Feb. 13, 2023),
https://www.npr.org/2023/02/10/1156166554/covid-19-pulse-oximeters-racial-bias; Pulse Oximeters Should Not Be Used to Diagnose COVID-
19, U.S. FDA Says, Reuters (Feb. 19, 2021), https://www.reuters.com/article/us-health-coronavirus-pulse-oximeter/pulse-oximeters-should-not-be-used-to-diagnose-covid-19-u-s-fda-says-idUSKBN2AJ2G7.
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Health care professional and hospital associations are also often
dependable sources of information that notify health care providers
about developments in the practice of various specialties and in the
administration of medical care, which can include potential
discrimination that may result from the use of certain patient care
decision support tools.\352\ Health insurance-related associations also
provide information to their members and the public.\353\ Relevant
information is also
[[Page 37648]]
provided through various nonprofit organizations in the field of AI.
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\352\ See, e.g., Augmented Intelligence in Medicine, Am. Med.
Ass'n, https://www.ama-assn.org/practice-management/digital/augmented-intelligence-medicine (updated Mar. 1, 2024); Clinical
Applications of Artificial Intelligence (webinar), Am. Coll. of
Physicians, https://www.acponline.org/meetings-courses/webinars/clinical-applications-of-artificial-intelligence (June 8, 2023). See
generally, Medical & Professional Associations, Meditech, https://www.meditec.com/resourcestools/professional-associations-list.
\353\ See, e.g., Artificial Intelligence, Nat'l Ass'n of Ins.
Comm'rs, https://content.naic.org/cipr-topics/artificial-intelligence; Creating Better Health Outcomes with Digital Tools and
Artificial Intelligence (webinar), Am.'s Health Ins. Plans, https://www.ahip.org/webinars/creating-better-health-outcomes-with-digital-tools-and-artificial-intelligence (Dec. 8, 2023).
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ONC's rule also provides an opportunity for covered entities to
learn about the data used in decision support interventions. Developers
of decision support interventions that develop certified health IT as
part of its Health IT Module are required to support making specific
information disclosures under ONC's rule regarding discriminatory bias
in their tools, including disclosure of source attributes, and risk
management and governance practices.\354\
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\354\ U.S. Dep't of Health & Hum. Servs., Off. of the Nat'l
Coordinator for Health Info. Tech., Health Data, Technology, and
Interoperability: Certification Program Updates, Algorithm
Transparency, and Information Sharing, Final Rule, 89 FR 1192
(January 9, 2024).
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OCR will assess each allegation that a covered entity is violating
Sec. 92.210 on a case-by-case basis. For example, when OCR
investigated complaints related to State Crisis Standards of Care
guidelines during the COVID-19 pandemic, the investigations involved a
fact-specific analysis of each of the guidelines in question. They also
included extensive technical assistance with States to revise their
Crisis Standards of Care guidelines to remove the alleged
discriminatory.\355\
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\355\ See, e.g., U.S. Dep't of Health & Hum. Servs., Off. for
Civil Rts., Civil Rights and COVID-19, Non-Discrimination in Crisis
Standards of Care, https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html; Press release, U.S. Dep't of Health
& Hum. Servs., Off. for Civil Rts., OCR Resolves Complaint with Utah
After It Revised Crisis Standards of Care to Protect Against Age and
Disability Discrimination (Aug. 20, 2020), https://public3.pagefreezer.com/content/HHS.gov/31-12-2020T08:51/https://www.hhs.gov/about/news/2020/08/20/ocr-resolves-complaint-with-utah-after-revised-crisis-standards-of-care-to-protect-against-age-disability-discrimination.html.
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In our analysis of whether a covered entity is in compliance with
Sec. 92.210(b)'s ``reasonable efforts to identify'' requirement, OCR
may consider, among other factors: (1) the covered entity's size and
resources (e.g., a large hospital with an IT department and a health
equity officer would likely be expected to make greater efforts to
identify tools than a smaller provider without such resources); (2)
whether the covered entity used the tool in the manner or under the
conditions intended by the developer and approved by regulators, if
applicable, or whether the covered entity has adapted or customized the
tool; (3) whether the covered entity received product information from
the developer of the tool regarding the potential for discrimination or
identified that the tool's input variables include race, color,
national origin, sex, age, or disability; and (4) whether the covered
entity has a methodology or process in place for evaluating the patient
care decision support tools it adopts or uses, which may include
seeking information from the developer, reviewing relevant medical
journals and literature, obtaining information from membership in
relevant medical associations, or analyzing comments or complaints
received about patient care decision support tools.
In summary, OCR recognizes the challenges in identifying the
discriminatory potential of every use of each patient care decision
support tool, and therefore Sec. 92.210(b) requires covered entities
to make reasonable efforts to identify tools that employ input
variables based on a protected basis.
Comment: Many commenters referred to potential devastating
consequences from the use of specific clinical algorithms \356\ and
recommended that Sec. 92.210 be revised to include a requirement for
covered entities to mitigate the risk of discrimination that results
from the use of clinical algorithms. Some commenters suggested that OCR
require specific mitigation efforts, such as requiring covered entities
to: develop and implement policies specific to covered entities' use of
clinical algorithms; require staff training; use clinical algorithms in
accordance with FDA clearance and developer's intended uses; use peer-
reviewed research to inform adjustments to clinical algorithms; notify
patients of suspect clinical algorithms; request an assessment of
discriminatory inputs from developers; neutralize any discriminatory
inputs by using the predominant cohort in the tool's training data; and
submit annual reports to OCR regarding their use of clinical algorithms
and mitigation efforts.
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\356\ Examples included race-adjusted correction factors used in
spirometry, nephrology, and cardiology; State Medicaid eligibility
systems that reduce benefits impacting historically marginalized
individuals disproportionately to the overall population; health
care utilization algorithms that use prior health care spending data
to predict future health care needs that results in under-
representing Black patients as compared to white patients; and other
examples discussed throughout this preamble.
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Response: OCR agrees with commenters' concerns about the potential
for harm resulting from discriminatory algorithms and the need to
mitigate the risks of discrimination when possible. However, we
acknowledge that it is not always possible to completely eliminate the
risk of discriminatory bias in patient care decision support
tools,\357\ and these tools also serve important health care functions.
Section 92.210(c) requires covered entities to make reasonable efforts
to mitigate the risk of discrimination resulting from the covered
entity's use of a patient care decision support tool identified in
Sec. 92.210(b). This standard allows a covered entity to adopt more
robust safeguards to prevent discrimination, should it choose to do so.
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\357\ See, e.g., Nat'l Inst. of Standards & Tech., Artificial
Intelligence Risk Management Framework (AI RMF 1.0), NIST AI 100-1,
(2023), https://doi.org/10.6028/NIST.AI.100-1.
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For example, in order to comply with Sec. 92.210(c)'s mitigation
requirement, a covered entity that uses the race-adjusted eGFR equation
could discontinue using that equation and instead use the revised eGFR
equation that does not adjust for race.\358\ The covered entity may
also implement measures to ensure that staff members follow proper
protocols when using the race-adjusted eGFR equation.\359\ OCR will
evaluate mitigation measures covered entities take on a case-by-case
basis to determine compliance with Sec. 92.210(c).
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\358\ See, e.g., Cynthia Delgado et al., Special Report: A
Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN
Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney
Disease, 79 a.m. J. of Kidney Diseases, 268-288 (Sept. 23, 2021),
https://www.ajkd.org/article/S0272-63862100828-3/fulltext.
\359\ See, e.g., Press Release, U.S. Dep't of Health & Hum.
Servs., Health Servs. & Rsch. Admin., Organ Procurement &
Transplantation Network, OPTN Board Approves Waiting Time Adjustment
for Kidney Transplant Candidates Affected by Race-Based Calculation
(Jan. 5, 2023), https://optn.transplant.hrsa.gov/news/optn-board-approves-waiting-time-adjustment-for-kidney-transplant-candidates-affected-by-race-based-calculation/.
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A covered entity's obligation to mitigate risk of discrimination
under Sec. 92.210(c) is consistent with the National Institutes of
Standards and Technology's (NIST) Artificial Intelligence Risk
Management Framework, which explains that AI bias mitigation helps
minimize potential negative impacts of AI systems while providing
opportunities to maximize positive impacts, without articulating
express mitigation measures.\360\ The same is true for patient care
decision support tools that a covered entity uses
[[Page 37649]]
in its health programs and activities for clinical decision-making.
---------------------------------------------------------------------------
\360\ Nat'l Inst. of Standards & Tech., Artificial Intelligence
Risk Management Framework (AI RMF 1.0), NIST AI 100-1, p. 4 (2023),
https://doi.org/10.6028/NIST.AI.100-1, (The NIST AI Framework
provides: ``Where tradeoffs among the trustworthy characteristics
arise, measurement provides a traceable basis to inform management
decisions. Options may include recalibration, impact mitigation, or
removal of the system from design, development, production, or use,
as well as a range of compensating, detective, deterrent, directive,
and recovery controls.'').
---------------------------------------------------------------------------
While we appreciate the breadth of mitigation techniques suggested
by commenters--and agree that many of those efforts would be best
practices to prevent algorithmic discrimination--we decline to require
covered entities to take any specific mitigation efforts under Sec.
92.210(c). We have determined that a reasonable efforts mitigation
requirement strikes the right balance between the need for covered
entities to mitigate the risk of discrimination resulting from their
use of patient care decision support tools and the burden placed on
covered entities. In the Proposed Rule, 87 FR 47883, we noted that
covered entities may choose to mitigate discrimination by establishing
written policies and procedures governing how clinical algorithms will
be used in decision-making, including adopting governance measures;
monitoring any potential impacts and developing ways to address
complaints; and training staff on the proper use of such systems in
decision-making. We encourage covered entities to take these and other
additional mitigating efforts to comply with Sec. 92.210.\361\ We
further note that this rule does not excuse a covered entity from
complying with any other applicable Federal or State law that may
apply, including but not limited to requirements for FDA approval where
appropriate, such as the Food Drug and Cosmetic Act \362\ and the
Medical Device Amendments.\363\
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\361\ See, e.g., Marshall H. Chin et al., Guiding Principles to
Address the Impact of Algorithm Bias on Racial and Ethnic
Disparities in Health and Health Care, 6 JAMA Network Open 12
(2023), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2812958; Coalition for Health AI, Blueprint for
Trustworthy AI Implementation Guidance and Assurance for Healthcare
(2023), https://www.coalitionforhealthai.org/papers/blueprint-for-trustworthy-ai_V1.0.pdf.
\362\ 21 U.S.C. 301 et seq.
\363\ Pub. L. 94-925.
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In addition, once a covered entity identifies a particular use of
patient care decision support tool under Sec. 92.210(b), a covered
entity's mitigation efforts under Sec. 92.210(c) may vary based on the
input variable or factor, as well as the purpose of the tool in
question. OCR acknowledges that some input variables may generate
greater scrutiny, such as race, which is highly suspect,\364\ as
compared to other variables, such as age, which is more likely to have
a clinically and evidence-based purpose. Some bases protected by
section 1557, such as age, are likely prevalent in patient care
decision support tools and may not require extensive mitigation efforts
under Sec. 92.210(c) if use of the variable in the tool does not
result in discrimination. For instance, where a tool employs an input
variable for age, the covered entity's mitigation efforts under Sec.
92.210(c) regarding that tool may include justifying the tool's use of
age as an input variable by showing that age is clinically indicated as
a measure in the particular tool and/or aligns with evidence-based
clinical best practices that do not result in discrimination. We
further note that the Age Act itself allows age distinctions under
certain circumstances, including when related to age distinctions that
reasonably take into account age as a factor necessary to the normal
operation or the achievement of any statutory objective of a program or
activity. 42 U.S.C. 6103(b)(1); 45 CFR 91.13 (adopting statutorily
permissive age distinctions found at 42 U.S.C. 6103(b)(1)).
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\364\ See, e.g., Michelle Tong & Samantha Artiga, Use of Race in
Clinical Diagnosis and Decision Making: Overview and Implications,
KFF (2021), https://www.kff.org/report-section/use-of-race-in-clinical-diagnosis-and-decision-making-overview-and-implications-issue-brief/.
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Comment: Some commenters indicated that clinicians trust the FDA's
process for reviewing and approving clinical use of patient care
decision support tools as well as published data illustrating a tool's
efficacy in their use of these tools.
Response: The FDA regulates the sale of medical devices (including
diagnostic tests) and monitors the ongoing safety and effectiveness of
regulated marketed devices.\365\ The FDA has released draft guidance on
Predetermined Change Control Protocol (PCCP AI/ML) \366\ and will be
publishing draft guidance for Artificial Intelligence/Machine Learning
(AI/ML)-enabled Device Software Functions: Lifecycle Management
Considerations and Premarket Submission Recommendations. In addition,
FDA is actively working through public-private partnerships to set
uniform guidelines on addressing bias in AI across its lifecycle.
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\365\ See U.S. Dep't of Health & Hum. Servs., Food & Drug
Admin., FDA's Role in Regulating Medical Devices, https://
www.fda.gov/medical-devices/home-use-devices/fdas-role-regulating-
medical-
devices#:~:text=FDA%20regulates%20the%20sale%20of,of%20all%20regulate
d%20medical%20products.
\366\ 88 FR 19648 (Apr. 3, 2023); see also U.S. Dep't of Health
& Hum. Servs., Food & Drug Admin., CDRH Issues Draft Guidance on
Predetermined Change Control Plans for Artificial Intelligence/
Machine Learning-Enabled Medical Devices, https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-issues-draft-guidance-predetermined-change-control-plans-artificial-intelligencemachine.
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Section 92.210 is concerned with ensuring that covered entities'
use of a patient care decision support tool does not result in
prohibited discrimination, which includes medical devices as
``automated or non-automated tool[s] . . . used by a covered entity to
support clinical decision-making.'' While FDA's premarket review
processes strive to minimize discriminatory biases in patient care
decision support tools before they are authorized to market, real world
post-market deployment of FDA-approved devices can introduce
discriminatory bias. Therefore, it is important to identify different
points of bias and provide an action plan for remediation.\367\
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\367\ See U.S. Dep't of Health & Hum. Servs., Food & Drug
Admin., About FDA: Patient Q&A, https://www.fda.gov/media/151975/
download#:~:text=The%20FDA%20does%20not%20regulate,by%20health%20insu
rance%20or%20Medicare; Alessandro Hammond et al., An Extension to
the FDA Approval Process Is Needed to Achieve AI Equity, 5 Nature
Machine Intelligence 96 (2023), https://www.nature.com/articles/s42256-023-00614-8.
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Comment: Many commenters suggested that covered entities should
share liability with algorithm creators for the consequences related to
covered entities' use of these tools because clinicians may lack
sufficient information to detect that an algorithm can result in
discrimination. Another commenter suggested that Sec. 92.210 should
impose strict liability on manufacturers of algorithms, not the end
users. Yet another commenter suggested that OCR create a safe harbor
for covered entities that use clinical algorithms consistent with and
within the scope of their intended purpose.
Response: Each covered entity is independently required to comply
with all provisions in section 1557, including Sec. 92.210. A covered
provider's liability under section 1557 is not contingent on or related
to a developer's potential liability under this rule or this provision.
As discussed above, Sec. 92.210(b) requires a covered entity to
identify use of patient care decision support tools in its health
programs and activities that employ input variables or factors that
measure race, color, national origin, sex, age, or disability, and
Sec. 92.210(c) requires covered entities to make reasonable efforts to
mitigate the risk of discrimination that results from the covered
entity's use of a tool identified in Sec. 92.210(b) in clinical
decision-making.
If a developer is subject to section 1557, Sec. 92.210 applies to
it in the same manner it applies to all covered entities. Under Sec.
92.210, covered entities must take requisite actions to ensure their
use of a patient care decision support tool does not result in
discrimination. We decline to impose strict liability on covered
entities in their use of these tools, including covered developers.
[[Page 37650]]
Comment: Some commenters opined that proposed Sec. 92.210 lacked
sufficient specificity and that our reference in the Proposed Rule to
covered entities' overreliance on clinical algorithms was confusing
because there is no definition or criteria about what it means to
``rely'' on a clinical algorithm.
Response: We appreciate commenters' concerns. We note that Sec.
92.210 relates to covered entities' use of patient care decision
support tools rather than their reliance on them. In the Proposed Rule,
we cautioned that a covered entity's overreliance on clinical
algorithms in its decision-making can result in discrimination, and
that covered entities should refrain from over-relying on patient care
decision support tools by using them beyond their reasonably expected
scope as a replacement or substitute for providers' clinical judgment.
87 FR 47880-82.
Comment: Some commenters characterized Sec. 92.210 as a novel
provision and argued that, in consequence, OCR investigative staff need
to conduct fact-specific analyses of allegations of discrimination.
Other commenters supported OCR's proposed approach to conduct a case-
by-case factual inquiry into compliance with Sec. 92.210. Many
commenters pointed out that proactive oversight by OCR is also needed
due to the non-transparent, systemic nature of this form of
discrimination, which may limit complaints.
Response: OCR will investigate each complaint under Sec. 92.210 on
a case-by-case basis. OCR will review all applicable evidence to
determine whether the covered entity took reasonable steps to identify
whether the patient care decision support tool it is using is a tool
that employs input variables that measure race, color, national origin,
sex, age, or disability under Sec. 92.210(b). When an investigation
reveals that a covered entity has appropriately identified its use of a
patient care decision support tool under Sec. 92.210(b), OCR will
determine whether the covered entity took reasonable efforts to
mitigate the risk of discrimination resulting from the use of the
patient care decision support tool at issue in accordance with Sec.
92.210(c), as described above. As we have affirmed elsewhere with
respect to other provisions of this final rule, OCR will employ all
available means to investigate alleged violations of Sec. 92.210,
including through complaint investigations and compliance reviews based
upon potential complaints in order to provide proactive oversight over
the use of these tools.
Comment: A professional association commenter recommended that
OCR's enforcement actions should consider whether covered entities have
set up incentives to pressure health care professionals to follow the
recommendations of clinical algorithms even if they conflict with the
professional's clinical judgment.
Response: We appreciate this comment, and OCR will take such
situations into account on a case-by-case basis when determining
whether a covered entity violates this provision as OCR evaluates the
facts in complaints brought under Sec. 92.210.
Comment: Commenters recommended that OCR work with covered entities
to achieve compliance by providing covered entities, specifically
physician practices, with technical assistance and guidance, to help
them integrate both clinical algorithms and improvements for these
algorithms into existing clinical workflows to increase efficiency and
minimize administrative burden.
Response: OCR seeks to provide covered entities with technical
assistance regarding compliance with all civil rights requirements,
including compliance with Sec. 92.210. OCR is committed to partnering
with covered entities to eliminate discrimination resulting from the
use of patient care decision support tools in covered entities' health
programs and activities.
Comment: Some commenters were concerned that complying with Sec.
92.210 would be difficult for smaller covered entities with fewer
resources.
Response: Section 92.210 applies to all covered entities regardless
of size, including smaller entities. All covered entities must make
reasonable efforts to mitigate the risk of discrimination resulting
from their use of a patient care decision support tool identified in
Sec. 92.210(b), but the size and resources of the covered entity will
factor into the reasonableness of their mitigation efforts and their
compliance with Sec. 92.210.
Comment: Some commenters encouraged OCR to require covered entities
to comply with Sec. 92.210 as quickly as possible, while one commenter
suggested that covered entities should be required to evaluate their
algorithms and mitigate bias within 12 months.
Response: We acknowledge that covered entities may need additional
time to comply with the new requirements in Sec. 92.210(b) and (c).
Therefore, OCR is revising Sec. 92.1 to reflect a delayed
applicability date that specifies covered entities must comply with
Sec. 92.210(b) and (c) within 300 days following the effective date of
the rule.
Request for Additional Comment
OCR seeks comment on whether we should engage in additional
rulemaking to expand the scope of Sec. 92.210, and if so, in what
ways. Specifically, OCR seeks comment on other decision support tools
that are being used in covered entities' health programs and activities
that do not directly impact patient care and clinical decision-making,
but may nevertheless result in unlawful discrimination in violation of
section 1557, and whether Sec. 92.210 should apply to such decision
support tools. For example, we are aware of decision support tools that
are used by health insurance issuers to determine amounts owed to them
or by providers for services rendered. Other examples include tools
used for automated coding for billing,\368\ and fraud, waste, and
abuse.\369\ Additionally, covered entities may use decision support
tools for administrative and operational activities, such as patient
scheduling, and we are aware that there is research suggesting that
these tools can result in rushed and inadequate care for lower
socioeconomic patients.\370\ Decision support tools may also be used to
allocate resources, such as allocating spending geographically on
diagnostic imaging that favors regions with historically more
expensive, high-tech equipment and a lower presence of historically
marginalized and underserved persons.\371\ OCR seeks comment on these
uses and others that may result in unlawful discrimination in violation
of section 1557, and whether Sec. 92.210 should be expanded to cover
these tools as well.
---------------------------------------------------------------------------
\368\ See, e.g., Jessica Miller, How Is AI Quickly Taking
Medical Coding to the Next Level?, Medicodio (June 6, 2023) https://
medicodio.com/how-is-ai-quickly-taking-medical-coding-to-the-next-
level/
#:~:text=AI%20has%20transformed%20medical%20coding,codes%2C%20and%20a
ssign%20them%20automatically.
\369\ See, e.g., Bill Siwicki, At UMich, AI-Based Fraud, Waste,
and Abuse System Aims to Cut Costs and Protect Patients,
HealthcareITNews (Aug. 1, 2023), https://www.healthcareitnews.com/news/umich-ai-based-fraud-waste-and-abuse-system-aims-cut-costs-and-protect-patients.
\370\ See, e.g., Howard Fine et al., Health Care Embraces AI,
Los Angeles Business Journal (June 12, 2023), https://labusinessjournal.com/special-reports/health-care-embraces-ai/.
\371\ See, e.g., Brent Nelson et al., Computerized Decision
Support for Concurrent Utilization Review Using the HELP System, 1
J. Am. Med. Informatics Ass'n. 339 (1994), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC116216/pdf/0010339.pdf.
---------------------------------------------------------------------------
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing Sec. 92.210 with modifications.
First, we are adding a Sec. 92.210(a), which reads
[[Page 37651]]
the same as proposed Sec. 92.210 except that we added ``General
prohibition'' to the beginning of the provision and replaced the term
``clinical algorithm'' with the term ``patient care decision support
tool.'' Second, we added Sec. 92.210(b), which states, ``A covered
entity has an ongoing duty to make reasonable efforts to identify uses
of patient care decision support tools in its health programs or
activities that employ input variables or factors that measure race,
color, national origin, sex, age, or disability.'' Third, we have added
Sec. 92.210(c), which states, ``For each patient care decision support
tool identified in paragraph (b) of this section, a covered entity must
make reasonable efforts to mitigate the risk of discrimination
resulting from the tool's use in the covered entity's health programs
or activities.''
Nondiscrimination in the Delivery of Health Programs and Activities
Through Telehealth Services (Sec. 92.211)
In Sec. 92.211, we proposed 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.
OCR sought 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 individuals with LEP. We invited comment on what such a provision
should include, and why the provisions at proposed Sec. Sec. 92.201
(Meaningful access for individuals with LEP), 92.202 Effective
communication for individuals with disabilities), and 92.204
(Accessibility of ICT for individuals with disabilities), would be
insufficient. Further, we requested comment on challenges with
accessibility specific to telehealth and recommendations for telehealth
accessibility standards that would supplement the effective
communication and ICT provisions of this part. We encouraged 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).
The comments and our responses regarding Sec. 92.211 are set forth
below.
Comment: Most commenters on this issue were supportive, stating
that a specific provision requiring nondiscrimination in delivery of
health programs and activities through telehealth services is important
for addressing health equity for underserved groups and areas, social
determinants of health, and improving access to a wide range of health
care. Some commenters added that the expansion of telehealth has been
particularly important for access to care for those who are
immunocompromised or otherwise at risk for COVID-19 and potential
future pandemics, those who live in rural communities, and those in
need of gender-affirming care. Many commenters called for increased
investment and training to promote technological literacy as a vital
complement to this effort.
Response: We agree that a standalone provision requiring
nondiscrimination in delivery of health programs and activities through
telehealth services is warranted and we appreciate the thoughtful
comments. We welcome the opportunity to promote health literacy and
provide technical assistance within our scope of authority.
Comment: A few commenters indicated that covered entities will
require additional time, technical assistance, and/or safe harbors to
come into compliance with this provision, particularly if specific
language access and accessibility requirements regarding telehealth
platforms are incorporated. Furthermore, one commenter contended that
regulation is premature since telehealth technology and platforms are
too new.
Response: While we appreciate the concerns expressed by covered
entities, we respectfully disagree with the proposition that it is
premature to regulate nondiscrimination in health programs and
activities delivered via telehealth. As stated in the Proposed Rule and
the Department's joint guidance with DOJ on nondiscrimination in
telehealth (Telehealth Guidance),\372\ covered entities that use
telehealth are already prohibited from doing so in a discriminatory
manner. The Telehealth Guidance explains covered entities'
responsibilities to ensure effective communication and the provision of
auxiliary aids and services (section 504 and Sec. 92.202) and the
provision of language assistance services for individuals with LEP
(title VI and Sec. 92.201). Telehealth platforms, in particular, are
also covered by the ICT provision (Sec. 92.204). Given the dramatic
expansion in the use of telehealth and continuing barriers in access to
care experienced by individuals due to inaccessibility of telehealth
services, we believe it is necessary and appropriate to regulate this
medium of health care provision. OCR will provide further technical
assistance and clarifying guidance as appropriate to help covered
entities further understand their responsibilities.
---------------------------------------------------------------------------
\372\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
U.S. Dep't of Justice, Civil Rts. Div., Guidance on
Nondiscrimination in Telehealth: Federal Protections to Ensure
Accessibility to People with Disabilities and Limited English
Proficient Persons (July 29, 2022), https://www.hhs.gov/civil-rights/for-individuals/disability/guidance-on-nondiscrimination-in-telehealth/index.html.
---------------------------------------------------------------------------
Comment: Some commenters requested that OCR apply a broad
definition of ``telehealth'' requesting inclusion of medical devices,
tests, and equipment used as part of telehealth services. Other
commenters requested OCR define telehealth as ``the use of digital
technology to deliver health care, health information, and other health
services, including diagnosis, treatment, assessment, monitoring,
communications, and education.''
Some commenters also requested that audio-only and remote patient
monitoring be required to comply with Sec. Sec. 92.201 (Meaningful
access for individuals with LEP), 92.202 (Effective communication for
individuals with disabilities), and 92.204 (accessibility of ICT for
individuals with disabilities).
Response: OCR has determined it is appropriate to codify the
definition of the term ``telehealth'' as provided by the Health
Resources and Services Administration \373\ and the Office of the
National Coordinator for Health Information Technology \374\ referenced
in the Proposed Rule at 87 FR 47884. As such, we are adding a
definition for telehealth to the final rule under Sec. 92.4. which
will read ``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. Technologies include videoconferencing, the internet,
store-and-forward imaging, streaming media, and terrestrial and
wireless communications.'' Audio-only and remote patient monitoring
services are included in this definition. Additionally, medical
devices, tests, and equipment that are used as part of a health program
or activity delivered through telehealth services must also be
accessible.
---------------------------------------------------------------------------
\373\ U.S. Dep't of Health Hum. Servs., Health Rsch. Servs.
Admin., What Is Telehealth?, https://www.hrsa.gov/rural-health/telehealth/what-is-telehealth.
\374\ HealthIT.gov, What Is Telehealth? How Is It Different from
Telemedicine?, https://www.healthit.gov/faq/what-telehealth-how-
telehealth-different-telemedicine.
---------------------------------------------------------------------------
Comment: Some commenters requested OCR amplify and make clear
[[Page 37652]]
that the privacy provisions under HIPAA are a part of this section.
Many commenters detailed privacy concerns specific to individuals with
disabilities and individuals with LEP. For individuals with
disabilities, concerns were expressed for those who lack privacy in the
home and might need additional functionality to be able to use
telehealth privately.\375\ Other commenters described concerns
individuals with LEP may have about their data being shared with
immigration or law enforcement.\376\
---------------------------------------------------------------------------
\375\ 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/.
\376\ Aswita Tan-McGrory et al., Addressing Virtual Care
Disparities for Patients With Limited English Proficiency, The Am.
J. of Managed Care (2022) https://www.ajmc.com/view/addressing-virtual-care-disparities-for-patients-with-limited-english-proficiency.
---------------------------------------------------------------------------
Response: Comments related to HIPAA are outside of the scope of
this rulemaking. However, we direct commenters to HIPAA guidance we
have released related to HIPAA and reproductive health care,\377\
protecting the security of health information,\378\ and audio-only
telehealth.\379\ Given our responsibility for HIPAA, OCR is very
sensitive to privacy concerns among both people with disabilities and
individuals with LEP and we remain committed to protecting their
privacy and confidentiality.\380\
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\377\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
HIPAA Privacy Rule and Disclosures of Information Relating to
Reproductive Health Care (June 29, 2022), https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/phi-reproductive-health/index.html.
\378\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Protecting the Privacy and Security of Your Health Information When
Using Your Personal Cell Phone or Tablet (June 29, 2022), https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/cell-phone-hipaa/index.html.
\379\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Guidance on How the HIPAA Rules Permit Covered Health Care Providers
and Health Plans to Use Remote Communication Technologies for Audio-
Only Telehealth (Jun. 13, 2022), https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/hipaa-audio-telehealth/index.html.
\380\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts., A
Health Care Provider's Guide to the HIPAA Privacy Rule:
Communicating with a Patient's Family, Friends, or Others Involved
in the Patient's Care (Sept. 16, 2008), https://www.hhs.gov/sites/default/files/provider_ffg.pdf.
---------------------------------------------------------------------------
Comment: One commenter requested that OCR clarify that proposed
Sec. 92.211 on nondiscrimination through telehealth services does not
apply to prescribing medication abortion or referring for abortion.
Response: The specific content of the health services provided via
telehealth is beyond the scope of this rulemaking. In the same way in
which we have generally declined to revise the final rule to address
how a particular provision applies in the context of the provision of a
particular type of care, we decline to do so here as well.
Comment: Many commenters wrote that ensuring equitable payment for
and access to telehealth across a range of modalities (including audio-
only telehealth, audio-video telehealth, real-time text, and in-person
services), as well as making payment rules for telehealth implemented
during the COVID-19 Public Health Emergency permanent, is needed to
ensure nondiscrimination in the administration of telehealth. Other
commenters said that audio-only telehealth should be reimbursed for
individuals without smartphones or reliable broadband service. One
State commenter requested CMS provide additional guidance on how this
rule would impact service delivery in rural areas in light of CMS'
audio-only service delivery in Medicare.
Response: Although OCR is cognizant of and sensitive to health
equity concerns involving coverage and payment policies for health care
services delivered via telehealth, such policies are outside the scope
of OCR authorities and the section 1557 rulemaking. However, in
general, OCR does not expect the rule to affect audio-only delivery of
Medicare services in rural areas.
Comment: Several commenters wrote that inadequate reimbursement of
telehealth and disparate medical management requirements limiting
access to telehealth are discriminatory and that such practices ought
to be prohibited.
Response: OCR will consider complaints raising the issues of
whether inadequate reimbursement of telehealth or disparate medical
management requirements limiting access to telehealth is discriminatory
under section 1557 on a case-by-case basis. To the extent a covered
entity's telehealth policies or practices delay or deny an individual's
access to a health program or activity delivered via telehealth, OCR
will consider whether the delay or denial is based on prohibited
grounds under section 1557 as set forth in this rule, including as a
discriminatory benefit design prohibited under Sec. 92.207(b)(2).
Covered entities have flexibility in determining the reimbursement
rates and medical management requirements in their plans, and this rule
does not establish specific reimbursement requirements or medical
management requirements. However, as noted elsewhere in this preamble,
such practices must be implemented in a nondiscriminatory manner.
Comment: Some commenters requested the rule prohibit covered
entities from requiring individuals to use telehealth for programs,
services, and assessments for which telehealth is inappropriate or
risks substandard services or findings. Some commenters also asked OCR
to require covered entities to offer in-person alternatives to
telehealth services.
Response: OCR recognizes that not all health programs and
activities are appropriately delivered via telehealth, and OCR will
review complaints related to payers or providers that require
individuals to receive programs, services, or assessments via
telehealth for potential discrimination concerns. However, we decline
to issue a blanket prohibition on the use of telehealth in specific
circumstances as requested by commenters, as the use in those
situations may not be per se discriminatory or there may be a
legitimate, non-discriminatory reason for the practice.
A covered entity may need to offer in-person alternatives to
telehealth, as a reasonable modification for individuals with
disabilities who cannot be properly provided with effective
communication or as a reasonable step to provide meaningful access for
individuals with LEP through telehealth services. However, we decline
to implement a general requirement that covered entities providing
telehealth offer an in-person alternative.
Comment: Many commenters urged that individuals with a disability
be afforded the opportunity to choose between telehealth and in-person
care based on the service delivery model that works better for their
health and communications needs and urged the inclusion of an opt-out
provision.
Response: Any individual with a disability who needs to opt-out
from receiving care via telehealth should request a reasonable
modification of policies and procedures from the covered entity. Unless
the reasonable modification fundamentally alters the health program or
activity, the covered entity should approve an in-person visit.
Comment: A number of commenters called on OCR to codify WCAG 2.0
(AA), WCAG 2.1 (AA),\381\ section 508, or related standards for
telehealth platforms. Some recommended requiring certifications of
compliance
[[Page 37653]]
from covered entities. One commenter recommended that covered entities
be required to attest to making their best effort to accommodate
patient needs. Another commenter suggested an elaborate alternative
regulatory scheme that would treat telehealth platforms like public
accommodations. Other commenters suggested that standards should be
adopted in such a manner as to grant covered entities time to come into
compliance, and others suggested safe harbors for compliance if a
covered entity meets WCAG standards.
---------------------------------------------------------------------------
\381\ Web Content Accessibility Guidelines 2.1 (AA), W3C World
Wide Web Consortium Recommendation, https://www.w3.org/TR/WCAG21/.
---------------------------------------------------------------------------
Response: OCR recognizes that this is a complex and evolving area,
and given the rapid evolution of platforms and technologies, we have
decided not to adopt specific accessibility standards at this time for
telehealth platforms, particularly given other ongoing rulemakings in
this field. Both OCR and DOJ recently issued NPRMs addressing the
accessibility of web content and mobile apps used by recipients of
Federal financial assistance and public entities, respectively.\382\
Those rulemakings provide greater clarity on obligations to ensure that
web content and mobile applications are accessible. This rulemaking
requires covered entities to ensure telehealth platforms are accessible
to individuals with disabilities, unless doing so would impose undue
financial and administrative burdens or would result in a fundamental
alteration in the nature of a covered entity's health programs or
activities. Specifically, OCR notes that communications before, during,
and after telehealth appointments must be accessible to individuals
with disabilities and individuals with LEP, consistent with pre-
existing section 504, title VI, and section 1557 requirements.
---------------------------------------------------------------------------
\382\ See 88 FR 63392 (Sept. 14, 2023) (HHS) and 88 FR 51948
(Aug. 4, 2023) (DOJ).
---------------------------------------------------------------------------
Comment: A number of commenters recommended expanding the
nondiscrimination requirement of Sec. 92.211 to designated companions
or caregivers of people with disabilities, since shared involvement is
often necessary to set and facilitate telehealth appointments.
Response: Yes, companions with disabilities are covered under the
effective communications requirements of this rule at Sec. 92.202, and
therefore we do not believe this language needs to be added. Companions
with LEP are similarly covered under the meaningful access requirements
of this rule at Sec. 92.201.
Comment: Many commenters stated that providers should assess
individuals with disabilities seeking to use telehealth platforms for
visual, cognitive, intellectual, mobility, and functional needs, and
that platforms should be adapted to address the needs of a wide variety
of people with diverse functional limitations who have difficulties
communicating through traditional telehealth, including, but not
limited to, people with visual, hearing, and speech disabilities.
Response: OCR agrees that such an assessment would be informative
and is recommended as a best practice and as a means of connecting
individuals with the most appropriate auxiliary aids and services to
meet their needs. However, OCR has concluded it is important to allow
covered entities flexibility in determining whether to assess
individuals with disabilities seeking to use telehealth platforms. We
therefore decline to adopt an assessment requirement at this time.
However, OCR will continue to monitor developments in methodology for
assessing individuals with disabilities.
Comment: Many commenters recommended that covered entities be
required to provide individuals with a Notice of Availability (Sec.
92.11) when covered entities electronically communicate to individuals
that they may make telehealth appointments with the covered entity.
Response: Such a scheduling communication is already covered by
Sec. 92.11(c)(5)(v), because it relates to services that ``require or
request a response from a participant, beneficiary, enrollee, or
applicant.''
Comment: A significant number of commenters recommended adopting
detailed specifications and performance standards for accessibility
features on telehealth platforms for individuals with specific
disabilities. Several commenters also said OCR needed to provide
specific requirements related to qualified interpreters on telehealth
platforms with ``specific provisions addressing accessibility in
telehealth services and particularly related to access for individuals
with disabilities and LEP individuals.''
Response: While OCR appreciates commenters' request for detailed
performance standards, we decline to adopt such provisions at this time
given the rapid evolution of platforms and technologies. Requirements
addressed elsewhere in the rule, including at Sec. Sec. 92.201
(Meaningful access for individuals with LEP) and 92.202 (Effective
communication for individuals with disabilities), provide a baseline
from which covered entities can tailor their compliance. OCR will
continue to consider issuing additional guidance on this topic.
Comment: One commenter wrote that audio-only visits are inherently
inferior to audio-visual telehealth visits as they exclude information
and meaning conveyed through visual cues, increasing chances for poor
communications, misdiagnoses, flawed evaluations, and other subpar
outcomes. This commenter advised requiring in-person care be available
on the same terms as telehealth.
Response: Although OCR appreciates the comment and recognizes that
audio-only telehealth communication may not be appropriate for all
circumstances, we decline to disallow audio-only as an option for
telehealth delivery. We believe this would erect an unnecessary and
unjustified barrier to telehealth for individuals who lack the quality
or consistent internet access necessary for audio-visual telehealth. As
stated previously, a covered entity may need to offer in-person
alternatives to telehealth to ensure effective communication for
individuals with disabilities (section 504, the ADA, and section 1557),
or meaningful access for individuals with LEP (title VI and section
1557), but we decline to implement a general requirement that in-person
care be available on the same terms as telehealth. For further
information, we once again direct commenters to the Telehealth
Guidance.\383\
---------------------------------------------------------------------------
\383\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
U.S. Dep't of Justice, Civil Rts. Div., Guidance on
Nondiscrimination in Telehealth: Federal Protections to Ensure
Accessibility to People with Disabilities and Limited English
Proficient Persons (July 29, 2022), https://www.hhs.gov/civil-rights/for-individuals/disability/guidance-on-nondiscrimination-in-telehealth/index.html.
---------------------------------------------------------------------------
Comment: One commenter wrote that, given that telehealth is
incorporated in ``information and communication technology for
individuals with disabilities'' (Sec. 92.204), it would be helpful to
explain the interaction between these two sections.
Response: This commenter is correct that telehealth is closely
related to the ICT section. ICT is generally a means by which to
facilitate access to information in a health program or activity,
whereas telehealth is a medium through which a health program or
activity is delivered and for which access is needed. Health programs
and activities provided through ICT include telehealth, which we define
as 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. In contrast, ICT relates to the technology and other
equipment,
[[Page 37654]]
such as 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. Thus, while telehealth interfaces and
applications are a form of ICT, the rapid expansion of its use by
providers and broad impact on the health care landscape necessitate
careful consideration independent of a broader ICT section. The
telehealth section is designed to ensure that health programs and
activities delivered via telehealth technologies are done so in a
manner that does not discriminate.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.211 without modification.
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 the part.
The comments and our responses regarding Sec. 92.301 are set forth
below.
Comment: Many commenters strongly supported OCR's clarification
that section 1557 provides an independent basis for regulation of
discrimination in covered health programs and activities. Supporters
indicated that the rule as proposed would provide for robust
enforcement of section 1557, consistent with existing law and the clear
intent of Congress. One commenter expressed support for the different
mechanisms of enforcement and emphasized the importance of enforcement
that is level, targeted, and constant to ensure long-term adherence to
section 1557's nondiscrimination provisions.
Response: OCR appreciates and acknowledges the need for strong
enforcement mechanisms in order to adequately address discrimination in
health programs and activities.
Comment: One commenter noted that making a clear procedure for
claims of discrimination on multiple bases is important, not only for
the complainant to fully understand their rights and remedies, but also
for the covered entity to know how best to respond to a grievance.
Commenters also suggested that OCR provide guidance on how covered
entities should proceed with complaints that involve multiple bases of
discrimination.
Response: OCR agrees that it is important to provide clarity to
both complainants and covered entities regarding the procedures for
raising a claim under section 1557. We currently offer resources on our
website to provide the public and covered entities with information
about the complaint process and how covered entities implement and
maintain compliance. As discussed in Sec. 92.303, in an effort to
simplify the complaint process, OCR is revising the regulatory text to
apply a single administrative enforcement procedure for discrimination
complaints filed under section 1557, regardless of the alleged basis of
discrimination. This will eliminate confusion for both covered entities
and the public with regard to how OCR will evaluate and investigate
allegations of discrimination brought under this part, including
allegations involving multiple bases of discrimination. Covered
entities should handle section 1557 grievances involving multiple bases
of discrimination under one process. OCR will continue to provide
guidance to covered entities on an ongoing basis to ensure compliance
with the rule.
Comment: Several commenters stated that section 1557 creates a
health-specific, nondiscrimination private cause of action. They opine
that, because Congress expressly adopted one provision to prohibit
discrimination on multiple grounds, the enforcement mechanisms
available under each of the referenced statutes are not intended to be
limited to the particular ground of alleged discrimination but rather
would be available regardless of the ground of discrimination at issue.
Many commenters strongly recommended that OCR expressly state, as
it did in the 2016 Rule preamble, that it will interpret section 1557
as authorizing a private right of action for claims of disparate impact
for all grounds of prohibited discrimination. They stated that making
the private right of action language explicit in the rule will provide
for transparency and patient protection and enable more consistent
enforcement of section 1557. Commenters stated that without a
disparate-impact theory of liability, a private right of action will
ring hollow for people of color and other systemically marginalized
groups. Additionally, commenters noted that in an era where artificial
intelligence and automated decision-making are increasingly responsible
for resource allocation, recognition of disparate-impact liability is
critical. Other commenters noted that a private right of action is
essential to ensuring that individuals who experience discrimination on
the basis of sex in health care are not solely reliant on OCR to
enforce the law and may be entitled to seek compensation through a
private right of action for the harm they experience.
Commenters further stated that the Supreme Court has affirmed the
right of all private individuals to sue in Federal court to challenge
violations of the protections of section 1557. Other commenters noted
that a private right of action is essential to ensuring that
individuals who experience discrimination on the basis of sex in health
care are not solely reliant on OCR to enforce the law. Commenters also
stated that by expressly including enforcement mechanisms ``available
under'' the statutes, Congress authorized disparate-impact claims to be
brought under section 1557.
Finally, commenters raised specific concerns regarding the Age
Act's administrative exhaustion requirement, 42 U.S.C. 6104(f), and
many commenters recommended that OCR include regulatory language in the
final rule clarifying that administrative exhaustion is not required
before a court action involving multiple bases of discrimination that
includes age can be filed by the complainant. These commenters stated
that because section 1557 is its own statute--enforceable by private
right of action in the courts--an older adult who is discriminated
against based on age and another basis should not be disadvantaged due
to the Age Act's administrative-exhaustion requirement.
Response: Courts have long recognized that section 1557 authorizes
a private right of action under any of the bases for discrimination.
OCR declines to revise regulatory text to adopt a stance on the
appropriate standards that apply to private litigants. This is an issue
appropriately addressed by the Federal judicial branch and not via
agency rulemaking.
Comment: One commenter requested that OCR clarify whether providers
caring for individuals with disabilities and relatives of such
individuals have the ability to bring a civil rights action in
appropriate cases, such as where the provider or relative are
themselves harmed by the plan's discriminatory conduct.
Response: OCR cannot provide legal advice as to whether an
individual can appropriately bring a private claim under section 1557.
If an individual--
[[Page 37655]]
including providers and relatives of a plan holder--believes they have
experienced discrimination prohibited by section 1557, they are able to
file a complaint with OCR. OCR will conduct a case-by-case analysis to
determine its jurisdiction over the complaint allegations.
Comment: Some commenters urged OCR to increase enforcement capacity
through coordination among agencies within the Department, and that the
final rule should authorize OCR to empower other Department components,
such as CMS, to investigate and enforce section 1557 claims.
Response: As a law enforcement agency with specialized knowledge
and delegated authority over section 1557 enforcement, OCR is the
agency within the Department that investigates and enforces section
1557 complaints. However, OCR continues to work with other agencies on
many different initiatives and issues, including to promote compliance
with Federal civil rights laws such as section 1557.
Comment: Some commenters suggested that OCR should pair enforcement
with robust outreach and education. Several commenters requested that
OCR postpone any enforcement action until after OCR provides education
resources and technical assistance, to allow time for different
practices to come into compliance without penalty.
Several commenters requested that OCR use enforcement discretion
for particular groups of providers. For example, one commenter asked
OCR to provide assurances that pharmacists can use reasonable clinical
judgment to treat patients within their scope of practice, and not be
subject to additional administrative burden and legal liability.
Another commenter requested that OCR use enforcement discretion and not
penalize physicians for failing to provide interpreter services as long
as they make reasonable efforts to satisfy the final rule's
requirements. This commenter also requested that OCR provide guidance
and support for physicians in rural and other hard to reach areas for
procuring and using the necessary technology to connect with remote
interpreters. Specifically, this commenter pointed to concerns with
physician practices in remote areas where interpreter availability is
inconsistent and remote connectivity to interpreter services is either
substandard or non-existent due to the lack of necessary broadband.
Response: We appreciate the commenters' concern, but section 1557
has been in effect since 2010 and OCR declines to postpone enforcement
past the effective date of 60 days after publication of the final rule.
We note, however, that we have provided delayed implementation dates
for a number of provisions. Further, prior to taking an enforcement
action (i.e., terminating Federal financial assistance or referring a
matter to DOJ for enforcement), OCR must attempt to achieve a covered
entity's voluntary compliance with the law, such as through providing
technical assistance and reviewing policies and procedures.\384\
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\384\ See, e.g., U.S. Dep't of Health & Hum. Servs., Off. for
Civil Rts., HHS Office for Civil Rights Resolves Complaints with CVS
and Walgreens to Ensure Timely Access to Medications for Women and
Support Persons with Disabilities (June 16, 2023), https://www.hhs.gov/civil-rights/for-providers/compliance-enforcement/agreements/cvs-walgreens/index.html.
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Comment: Some commenters recommended adding a new provision
requiring OCR to publish general information about the number and types
of complaints received and resolved on a yearly basis and to publicly
post information regarding resolution agreements within 14 days of
resolving a complaint.
Response: Much of the information requested is already provided to
Congress annually through OCR's Congressional Justifications and these
annual justifications are also available on OCR's website.\385\ In
addition, OCR posts its resolution agreements to its website, available
to anyone to review. We intend to continue with this practice as more
cases are resolved.
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\385\ Current and past OCR Congressional Justifications can be
found at https://www.hhs.gov/ocr/about-us/budget/index.html.
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Comment: Some commenters were also concerned with mandatory
arbitration agreements and recommended that OCR include a specific
provision prohibiting insurers from requiring binding arbitration as
the exclusive means to resolve a complaint arising under section 1557.
These commenters were concerned that binding arbitration greatly favors
defendants, particularly large corporations.
Response: OCR appreciates concerns with regards to arbitration but
notes that agreements between private parties is beyond the scope of
this rulemaking.
Summary of Regulatory Changes
For the reasons set forth above and in the Proposed Rule and
considering the comments received we are finalizing the provisions as
proposed in Sec. 92.301, without modification.
Notification of Views Regarding Application of Federal Religious
Freedom and Conscience Laws (Sec. 92.302)
In proposed Sec. 92.302, OCR proposed an administrative process
under which recipients can notify OCR of their views that they are
exempt from certain provisions of section 1557 due to an applicable
Federal conscience or religious freedom law. This proposed provision
was not in either the 2016 or 2020 Rule.
Proposed Sec. 92.302(a) provided that a recipient may notify OCR
of its view that it is exempt from certain provisions of this part due
to the application of a Federal conscience or religious freedom law.
Proposed Sec. 92.302(b) provided that 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 proceed with any investigation or enforcement activity
regarding that recipient's compliance with the relevant provisions of
this part. We further explained that any relevant ongoing investigation
or enforcement activity regarding the recipient shall be held in
abeyance until a determination has been made under Sec. 92.302(c).
Proposed Sec. 92.302(c) provided that based on the information
provided in the notification under Proposed Sec. 92.302(a), 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 with respect to specific
contexts, procedures, or health care services, based on an applicable
Federal conscience or religious freedom law. In doing so, we further
explained that OCR will assess whether there is a sufficiently concrete
factual basis for making a determination and will apply the applicable
legal standard of the relevant law. Proposed Sec. 92.302(c) also
provided that OCR will communicate its determination to the recipient.
Proposed Sec. 92.302(d) provided that if OCR determines that a
recipient is exempt from the application of certain provisions of this
part or modified application of the provision is required as 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.
The comments and our responses regarding Sec. 92.302 are set forth
below.
[[Page 37656]]
Comment: Many commenters expressed support for the proposed
provision primarily because, in their view, Sec. 92.302 would balance
the need to protect both the religious and conscience views of
recipients and the civil rights protections for patients, providers,
and consumers. In commenting on the purpose of section 1557, one
religious, organizational commenter stated that it ``strongly supports
the principle of nondiscrimination in health programs and activities
established by the ACA and the promulgation of regulations to ensure
that principle is implemented robustly'' because ``[a]ccess to health
care is essential to promote and protect the inherent and inalienable
worth and dignity of every individual.'' Another religious,
organizational commenter stated that ``[e]nsuring access to health
coverage and health care, and removing barriers to these, is without
question a laudable goal.''
Response: OCR appreciates these commenters' views and agrees that
Sec. 92.302 allows OCR to fully consider and uphold religious freedom
and conscience laws as well as civil rights laws for patients,
providers, and consumers, to ensure broad access to health care for all
individuals.
Comment: Many other commenters opposed the addition of Sec.
92.302. Commenters maintained that the process for notifying OCR of
their exemption requests would burden religious entities and favor the
interests of third parties. Some commenters raised concerns that claims
of third-party harms can be used by opponents of religious liberty as a
basis for denying any religious exemption. Additionally, a few
commenters asserted that any investigation by OCR that excludes
consultation with the Conscience and Religious Freedom Division will
lead to religious and conscience objectors losing to claims of third-
party harms. Commenters thus requested that OCR explain the types of
harm that may overcome religious objections.
Response: OCR appreciates commenters' objections to Sec. 92.302
and recognizes the request for guidance and clarification. In response
to commenters who stated that the notification process itself burdens
religious entities, OCR has added clarifications to the regulatory text
stating that recipients may rely on the protections in religious
freedom and conscience laws or seek further assurance of these
protections from OCR, if they wish. OCR notes that under revised Sec.
92.302, recipients are not required to seek assurance of an exemption
in advance but may raise a claim under an applicable Federal religious
freedom and conscience protection in the context of an OCR
investigation or enforcement action. Also, we have revised Sec.
92.302(a) to make clear that, insofar as the application of any
requirement under this part would violate applicable Federal
protections for religious freedom and conscience, such application
shall not be required. This language is consistent with language added
to Sec. 92.3(c) and has been interpreted by courts to support the
Department's position that it ``will abide by RFRA in any enforcement
of Section 1557'' and that the Department ``has never enforced section
1557 to require a provider with a religious objection to perform gender
transition services.'' Am. Coll. of Pediatricians v. Becerra, 2022 WL
17084365 (E.D. Tenn. 2022) (citing to this language from the 2016 Rule
as support).
In making determinations under Sec. 92.302, OCR will faithfully
apply the legal standards set forth in the Federal religious freedom or
conscience law at issue. For example, RFRA provides that the Federal
Government may not substantially burden a person's exercise of religion
unless ``it demonstrates that application of the burden to the person--
(1) is in furtherance of a compelling governmental interest; and (2) is
the least restrictive means of furthering that compelling governmental
interest.'' 42 U.S.C. 2000bb-1(b). Further, while case law interpreting
RFRA requires consideration of any potential third-party harms, such
harms, where relevant, are one of several factors that will be
considered. Other Federal religious freedom and conscience laws set
forth different tests. For example, a provision of the Church
Amendments, 42 U.S.C. 300a-7, states that the receipt of Federal
financial assistance (under certain statutes implemented by HHS) ``by
any individual or entity does not authorize any court or any public
official or other public authority to require . . . such individual to
perform or assist in the performance of any sterilization procedure or
abortion if his performance or assistance in the performance of such
procedure or abortion would be contrary to his religious beliefs or
moral convictions,'' id. 300a-7(b)(1). When administering its exemption
process, OCR will carefully apply the text of these statutes and
judicial precedents interpreting them, including by being mindful of
the ways in which the texts of these statutes differ from one another.
We continue to believe that this approach is most consistent with
the Federal religious freedom and conscience protections. In addition,
OCR has consulted with the appropriate Department staff regarding the
application of religious freedom and conscience protections during this
rulemaking and will continue to engage staff during OCR's enforcement
of the final rule.
Comment: Many commenters said that by not allowing a categorical
pre-enforcement exemption and instead making the exemption process
case-by-case, OCR will increase doubt among providers, inviting
constant reliance upon administrative adjudication and litigation that
will cost unnecessary time and money. Some commenters asserted that
OCR's consideration of claims on a case-by-case basis is problematic
for large health care systems with multiple sites of care. These
commenters raised concerns that hospital systems would be deprived of
the clarity and certainty needed to adhere to their religious
principles and to establish compliance with policies covering all
member hospitals, such that the health system would ensure that claimed
exemptions were being appropriately and narrowly applied. These
commenters claimed that because a recipient would be left with
significant uncertainty until OCR considered any enforcement action,
the process of claiming a pre-enforcement exemption with OCR affords
few assurances of future enforcement protections.
Still, many other commenters supported the Sec. 92.302 process
because, in their view, such a case-by-case inquiry allows OCR an
opportunity to consider objections in the context-specific manner that
Federal religious freedom laws like RFRA require. Many commenters
emphasized that in the context of health care under section 1557, the
government has a compelling interest in not only preventing
discrimination but ensuring taxpayer dollars are not used to further
discrimination. Other commenters, however, asserted that RFRA imposes
an affirmative obligation on the government to respect and protect
religious liberty and is not a defensive argument for individuals to
raise on a case-by-case basis.
Response: OCR understands some commenters' concerns and opposition
to the proposed provision requiring case-by-case determinations. OCR
maintains an important civil rights interest in the proper application
of Federal conscience or religious freedom protections, which requires
taking a case-by-case approach to such determinations. Among other
things, this allows OCR to determine whether the government has a
compelling
[[Page 37657]]
interest in denying an exemption to a particular party; \386\ to
consider, when relevant under the applicable legal standard, any harm
an exemption could have on third parties, including other recipients,
providers, patients, and the public; and to evaluate whether imposing
burdens on a covered entity is the least restrictive means of
furthering a compelling government's interest.\387\
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\386\ Fulton v. City of Phila., 593 U.S. 522, 541-42 U.S.
(2021).
\387\ See Burwell v. Hobby Lobby Stores, Inc., 573 U.S. 682, 739
(2014) (Kennedy, J., concurring) (``Among the reasons the United
States is so open, so tolerant, and so free is that no person may be
restricted or demeaned by government in exercising his or her
religion. Yet neither may that same exercise unduly restrict other
persons, such as employees, in protecting their own interests,
interests the law deems compelling.'').
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However, to address commenters' concerns, OCR has revised Sec.
92.302(a) to state that a recipient may ``rely on applicable Federal
protections for religious freedom and conscience, and consistent with
Sec. 92.3(c), application of a particular provision(s) of this part to
specific contexts, procedures, or health care services, shall not be
required where such protections apply.'' When a recipient acts based
upon its good faith reliance that it is exempt from providing a
particular medical service due to the application of relevant religious
freedom and conscience protections (e.g., RFRA), OCR will not seek
backward-looking relief against that recipient even if the recipient
had not affirmatively sought assurance of an exemption under Sec.
92.302(b). But if OCR determines, after an investigation, that the
recipient does not satisfy the legal requirements for an exception, it
will seek forward-looking relief as appropriate under the facts.
If the recipient wishes to receive an assurance from OCR regarding
an exemption under any applicable religious freedom and conscience
laws, it may do so under Sec. 92.302(b) either prior to, or during the
course of, an investigation. We understand that there was some
confusion regarding the ``case-by-case approach'' discussed in how OCR
proposed to evaluate exemption requests under Sec. 92.302(b). We
clarify here that a recipient may seek assurance of an exemption
applying to specific contexts, procedures, or health care services
generally. When OCR makes a case-by-case determination, this refers to
the evaluation of the exemption assurance request as a whole--which may
be requesting assurance of an exemption from a category of procedures
or health care services. Thus, when we indicate that exemption requests
will be evaluated on a case-by-case basis, this does not mean that a
recipient must seek assurance of an exemption each time such procedure
or health care is sought if an exemption already applies. Rather, a
recipient may demonstrate that it is entitled to an exemption due to a
religious or conscience objection to a particular provision in this
part, as applied to specific contexts, procedures, or health care
services.
A recipient may obtain assurance of its exemption in multiple ways
under Sec. 92.302(b). For example, if a recipient is seeking assurance
of an exemption while there is no investigation pending, the
notification to the OCR Director under Sec. 92.302(b) would include:
(1) identification of the provision of care to which the covered entity
objects, specifying whether the objection is to the service overall or
to the provision of care in a specific circumstance (per item (1)); (2)
an explanation of the legal basis supporting the claim (per item (2));
and (3) the factual basis supporting the claim (per item (3)). Thus,
for example, if a Catholic hospital is seeking an assurance of an
exemption from having to perform sterilization procedures that would
conflict with the religious tenets of their institution, their
notification under Sec. 92.302(b) would potentially include: (1) the
provision to which there is an objection and that the objection is to
provision of a procedure overall, i.e., sterilization procedures that
are prohibited by their religious tenets; (2) that they should be
exempt under a specified religious freedom or conscience law; and (3)
evidence that it, for example, never provides sterilization in
violation of a particular religious or conscience belief for any
patient, no matter their sex.
Alternatively, if a covered entity is seeking assurance of an
exemption during an OCR investigation, it may similarly submit a
notification under Sec. 92.302(b). This notification would include the
same information, but the factual basis for the claim would also
discuss the specific context of the investigation in question. Though
raised in response to a specific complaint allegation, the recipient
may use this same notification to seek assurance of an exemption for
the same circumstances going forward.
To take an example drawn from enforcement experience, OCR
investigated allegations that a Catholic hospital discriminated against
the complainant when it refused to allow his physician to perform a
hysterectomy as a form of gender affirming care at their facility. The
hospital confirmed during the investigation: (1) it did not perform the
particular type of care or procedure (hysterectomy) on any patient
under the circumstances (as it performs ``direct sterilization'' only
for ``the cure or alleviation of a present and serious pathology and a
simpler treatment is not available''); (2) that it was raising a
defense under RFRA, citing the relevant legal standard; and (3) the
factual basis for not providing such medical care and how the
hysterectomy request conflicted with the exercise of its religious
beliefs. OCR evaluated the complaint and the hospital's response in
light of its obligations under RFRA, and determined that to require the
hospital to allow the procedure in question to take place at their
facility would result in a substantial burden on their religious
exercise. OCR further found that section 1557's prohibition on sex
discrimination as applied to the facts of this case was not the least
restrictive means of achieving the government's compelling interest in
preventing discrimination and therefore closed the matter.
Comment: Some commenters who supported the provision expressed
appreciation that the process outlined in Sec. 92.302 would allow OCR
to consider an exemption's potential harms to third parties, such as
patients or the public. Many commenters believed that this type of
exemption process is structured to promote equity and transparency,
while ensuring compliance with relevant legal requirements. Multiple
commenters shared stories about denials of care, including in medical
situations in which patients were seeking emergency services. One
commenter reported an instance in which a woman was forced to deal with
serious health complications when her treatment was delayed after
emergency room staff learned of her sexual orientation. In another
example, a commenter recalled that a pediatrician's office refused to
make an appointment for an infant because the patient's parents were
lesbians. Other commenters said a hospital refused to allow doctors
with admitting privileges to provide their patients with, for instance,
medically necessary gender-affirming care inside their facilities. Many
commenters stated that even where patients are able to obtain the
services from another provider, the delay in receiving care may cause
irreparable harm. Multiple commenters described that the stress of
being denied medical care and the fear of facing similar denials in the
future can have serious negative health outcomes.
Some commenters who supported proposed Sec. 92.302 compared the
provision to the title IX religious exception, explaining that they
preferred an administrative process that
[[Page 37658]]
protects religious liberty, such as that proposed in Sec. 92.302, over
an exception that might be too broad.
Response: OCR appreciates these comments and agrees that the Sec.
92.302 exemption process is the better approach.
Although commenters compared the proposed Sec. 92.302 process with
the title IX religious exception when expressing their support, OCR
makes clear that the process provided under Sec. 92.302 is separate
and apart from title IX and this new provision does not rely upon or
effectuate title IX's religious exception. Rather, as explained above,
this provision clarifies the applicability of religious freedom and
conscience protections and provides a process for OCR to respect
applicable Federal religious freedom and conscience laws for specific
recipients, whether or not they are religious organizations, in its
enforcement of section 1557.
Comment: Several commenters who opposed this provision requested
that OCR provide recipients with a categorical exemption, similar to
what, in their view, was captured by the 2020 Rule through the
importation of the title IX religious exception. In these commenters'
view, such importation would provide a categorical exemption from
providing procedures that would violate their religious beliefs. Many
commenters also argued for incorporation of the title IX religious
exception to address their concerns over what they viewed as the
complexities, inconsistencies, and unpredictable nature of the Sec.
92.302 process.
Many other commenters also stated that the process at Sec. 92.302
is too burdensome and unclear, and in their view, it would effectively
prohibit a provider from abstaining from procedures that violate their
religious convictions. Additionally, some commenters stated that these
burdens were unfair to religious employers, especially small employers,
who the commenters said will refrain from applying for Federal funding,
further harming patients due to limited providers.
A few commenters stated that, as proposed, Sec. 92.302 forces
religious entities to expose themselves to potential sanctions by
requesting an exemption. Requesting any exemption, commenters argued,
makes the recipient a target for an agency that, in their view, is a
``bully'' to religious organizations. Several commenters expressed
concerns that in requesting an exemption, the recipient will lose, in
their views, its ``privacy and anonymity,'' which could have a chilling
effect on its provision of health care services.
Response: OCR appreciates and respects commenters' concerns
relating to their religious convictions. The Sec. 92.302 process
demonstrates OCR's concerted effort to enforce Federal
antidiscrimination laws and apply Federal religious freedom and
conscience laws. Section 92.302 provides an administrative process, not
implemented in either the 2016 or 2020 Rule, which responds to the
shortcomings of both rules. Through the Sec. 92.302 process, OCR is
committed to implementing a rule that clarifies legal obligations and
maintains transparency about its enforcement mechanisms.
Moreover, as previously addressed, supra, at Sec. 92.208, OCR
complies with the protections in the ACA itself; the Church, Coats-
Snowe, and Weldon Amendments; the generally applicable requirements of
RFRA; and other applicable Federal laws that provide religious freedom
and conscience protections--Sec. 92.302 provides an administrative
process through which providers may rely upon and assert these
protections.\388\ This provision helps ensure that recipients have an
opportunity to seek assurance from OCR about the application of
religious freedom and conscience protections. OCR does not seek to
deprive a recipient of their ``privacy or anonymity,'' and the
information requested is only that which is necessary to provide
assurance of the exemption or modification that the recipient is
seeking.
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\388\ See also U.S. Dep't of Health & Hum. Servs., Safeguarding
the Rights of Conscience as Protected by Federal Statutes, Final
Rule, 89 FR 2078 (Jan. 11, 2024).
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To clarify further, recipients may seek an assurance of an
exemption under these Federal religious freedom and conscience laws at
various points in time, including prior to an investigation or during
an ongoing OCR proceeding. To begin, as explained above, a recipient
may avail itself of the general application of Sec. 92.302(a) and
``rely on applicable Federal protections for religious freedom and
conscience, and application of a particular provision(s) of this part
to specific contexts, procedures, or health care services, shall not be
required.'' Should the recipient seek an assurance, it may--prior to
any administrative investigation and enforcement--do so by filing a
notification with OCR under Sec. 92.302(b). OCR will then acknowledge
receipt of the notification within 30 days, and the recipient may rely
on a temporary exemption, per Sec. 92.302(c)(1), while OCR adjudicates
the assurance of exemption request. In instances where OCR has already
initiated an investigation, the recipient may, during the pendency of
that investigation, similarly notify OCR of their belief they are
entitled to an exemption under the process provided at Sec. 92.302(b).
The notification will serve as a defense to the relevant investigation
or enforcement activity, and a temporary exemption will then be in
place per Sec. 92.302(c)(2), pending OCR's determination regarding the
request for assurance of the exemption or the conclusion of the
investigation.
Finally, OCR disagrees with and respectfully objects to the
characterization that it seeks to ``bully'' religiously affiliated
recipients or expose them to potential sanctions. Religiously
affiliated hospitals and health care facilities play a large role in
the health care system, and OCR recognizes the critical patient care
needs they provide, particularly in reaching underserved communities.
As previously stated, the 2022 NPRM provided factual findings with
respect to health care accessibility in the United States based upon
health care capacity by providers, population demands, and geographic
limitations. 87 FR 47840. A detailed discussion about these
considerations can be found in the Regulatory Impact Analysis. In
addition, OCR seeks to ensure Federal civil rights protections are
fulfilled and has consulted with the appropriate staff regarding the
application of religious freedom and conscience protections during this
rulemaking and will continue to engage such staff during OCR's
enforcement of the final rule.
Comment: Many commenters inquired about OCR's timeline for reaching
a determination on a recipient's request. Specifically, commenters
objected to the language in proposed Sec. 92.302(c) that provides
that, ``OCR may determine at any time whether a recipient is exempt
from the application of certain provisions of this part'' because, in
their view, this leaves open-ended the start and end points of the
process. Some commenters opined that this uncertainty could result in
disruptions or inappropriate denials of care while a recipient awaits a
determination. Other commenters suggested that OCR amend Sec.
92.302(c) to clarify what is intended by the clause ``may determine at
any time'' because it may conflict with the provision in Sec.
92.302(b) that such determinations will be made ``promptly.''
Many commenters recommended that OCR publish the anticipated
timeframe for OCR's review of exemption requests, notify the requesting
individuals/organizations about when OCR anticipates their review will
be
[[Page 37659]]
complete, and instruct the requesting individual/organization to notify
patients if they will not be offering the service or treatment under
review during that period. Commenters expressed the need to set a
reasonable timetable to ensure that requests for exemptions are
processed quickly to not impede or delay patient care. Some commenters
also proposed that OCR publicize de-identified data on conscience
claims and their respective review timelines to ensure public and
private entities can monitor any access issues, should they occur.
Many commenters who opposed the process described in Sec. 92.302
explained that the provision lacks the guidance or clarity necessary
for recipients to comply. For example, several commenters noted that in
proposed Sec. 92.302(a), OCR merely invites health care entities to
express their views on whether their Federal religious freedom and
conscience rights would be violated but provides no information about
when a response should be expected. Some commenters explained that
proposed Sec. 92.302(b) appears to contemplate that recipients would
wait until they are investigated or subject to an enforcement action
before notifying OCR of their view that Federal religious freedom and
conscience laws protect them. According to commenters, as proposed,
Sec. 92.302 provides no incentive for recipients to notify OCR any
earlier than that, since the subsection appears to impose no obligation
on OCR to weigh the notification or request until such an investigation
or enforcement action is live.
Other commenters pointed to the purported lack of guidance
regarding the types of records and facts that would assist OCR in
reaching a determination on the exemption request. Some commenters
asserted that Sec. 92.302(c) also does not explain how OCR will make
final determinations and omits discussion of a recipient's potential
recourse for appeal in the event of an adverse decision from OCR.
Response: OCR appreciates commenters' suggestions and concerns and
understands the desire for additional clarity and an established
timeline under which OCR will process requests for assurances of
exemptions and notify recipients of any determination. We agree that
there is value in providing more detail regarding what obligations OCR
and recipients have during this process, and so have revised Sec.
92.302. These revisions provide, among other things: (1) a general
application provision stating that a recipient may rely on applicable
Federal protections for religious freedom and conscience; (2) clarity
on what a notification for an assurance of a conscience or religious
freedom exemption must contain; (3) a temporary exemption that will
take effect upon the recipient's submission of the notification,
regardless of whether the recipient is being investigated, and that
will remain valid during the pendency of OCR's review of the request
and any administrative appeal; (4) a general timetable under which OCR
will acknowledge and begin to evaluate requests for assurances of
exemptions; (5) additional clarity with regard to the scope of an
exemption that has been assured under Sec. 92.302(d); and (6) an
administrative appeal process for recipients receiving adverse
determinations.
First, Sec. 92.302(a) now provides that a recipient may rely on
applicable Federal protections for religious freedom and conscience,
and application of a particular provision(s) of this part to specific
contexts, procedures, or health care services, shall not be required,
and does not violate section 1557 if it so relies.
Second, Sec. 92.302(b) now provides that a recipient may notify
OCR of its view that it is exempt from certain provisions of this part
due to the application of Federal protections for religious freedom and
conscience and seek assurance of that exemption. This notification must
be in writing directed to the OCR Director and the notification must
include (1) the particular provision(s) of this part to which the
recipient objects; (2) the legal basis supporting the assurance of
exemption request, including the standards governing the applicable
conscience or religious freedom law; and (3) the factual basis
supporting the recipient's view that it is exempt, including
identification of the conflict between the recipient's conscience or
religious beliefs and the application of a provision in this part,
which may include the specific contexts, procedures, or health care
services that the recipient asserts will violate their conscience or
religious beliefs overall.
Third, Sec. 92.302(c) now provides that a recipient's notification
and request for an assurance of an exemption to OCR will trigger the
extension of a temporary exemption to the recipient. This exemption
will cover the period of time it takes OCR to reach a determination on
the request. The temporary exemption shall apply only to the
provision(s) as applied to specific contexts, procedures, or health
care services identified in the recipient's notification to OCR and
will exempt conduct that occurs during the pendency of OCR's review and
determination regarding the assurance of exemption request. In the
event that there is an investigation or enforcement activity regarding
the recipient related to the specific provisions for which an assurance
of exemption has been requested, the temporary exemption will serve as
a defense through the investigation or until OCR has made a
determination on the assurance of exemption request, or through the
administrative process if the recipient seeks an appeal under Sec.
92.302(e). During this time, a recipient's temporary exemption shall
remain effective. OCR will work promptly to reach a determination
regarding the request.
Fourth, with respect to OCR's expected timetable for review, Sec.
92.302(c) now provides that for pre-enforcement requests for an
assurance of an exemption, OCR shall provide the recipient with email
confirmation within 30 days of a recipient's notification acknowledging
receipt of their request and stating that OCR will work expeditiously
to reach a determination. If the request for an assurance of religious
freedom and conscience exemption is received during the pendency of an
investigation, it shall serve as a defense to the relevant
investigation or enforcement activity until the final determination of
the recipient's request, the conclusion of the investigation, and any
relevant appeal. The temporary exemption shall exempt the recipient
from the provision of care at issue in the investigation until a final
determination is made on recipient's notification request or
investigation, or during the pendency of any appeal.
Fifth, OCR has revised Sec. 92.302(d) to clarify the effect of an
exemption. The assurance of an exemption would exempt the recipient
from OCR's administrative investigation and enforcement with regard to
the application of a particular provision, which may include the
specific contexts, procedures, or health care services that the
recipient asserts will violate their conscience or religious beliefs.
The exemption assurance will not apply to all contexts, procedures, or
health care services. A recipient must otherwise have a legitimate,
nondiscriminatory reason for denying or limiting service outside the
scope of the granted exemption assurance, and any such decision must
not be based on unlawful animus or bias, or constitute a pretext for
discrimination. For example, a hospital with a religious exemption to
not provide sterilizations outside of those permitted under their
religious tenets may not rely on the exemption to broadly decline all
health care services,
[[Page 37660]]
e.g., cancer treatments, to any individual if the hospital otherwise
provides that care.
Sixth, Sec. 92.302(e) now clarifies that a recipient may appeal an
OCR determination under this section. The relevant revisions provide
that recipients subject to an adverse determination of their request
for assurance of an exemption may appeal OCR's determination of that
request. Recipients who have been denied an exemption assurance under
Sec. 92.302 may raise their request before an administrative hearing
examiner from the Department with the same procedural protections
outlined for such administrative hearings under 45 CFR part 81. The
temporary exemption granted under Sec. 92.302(c) would remain in
effect until completion of the administrative appeal process.
Comment: Many commenters supportive of the outlined process also
urged OCR to revise proposed Sec. 92.302 to require OCR to make
publicly available, or publish on its website, all determinations for
any exemptions claimed or granted under Sec. 92.302. A few commenters
made specific suggestions for what the public postings should contain.
These commenters proposed that postings should include the name(s) of
the recipient requesting the exemption, the factual basis asserted by
that recipient demonstrating its eligibility under Federal law, OCR's
analysis of those facts, and the specific provision(s) of the rule to
which an exemption is recognized. A handful of other commenters raised
the possibility of requiring exemption determinations to be published,
within 10 days of issuance, in the Federal Register and on the
Department's website. Commenters also suggested that the notice should
be accompanied by an electronic link to documents that specifically
state the nature, scope, and duration of the exemption granted.
Many commenters discussed that, in addition to promoting
transparency, providing notice to the public of religious and
conscience exemptions granted would provide guidance both to providers
and patients regarding their rights and responsibilities under section
1557, reducing confusion that can impede equitable access to care,
particularly for the vulnerable populations the rule is designed to
protect. Many commenters stated that it is important that individuals
seeking care or coverage know whether the health providers or issuers
they are considering do, in fact, provide the services they need--
including whether they will be presented with all available care
options--and whether they will feel accepted and welcomed by the
provider they see.
Response: OCR appreciates commenters' suggestions for revisions to
the rule to provide notice to the public regarding assurances of
exemptions granted under this provision, including through having OCR
post information regarding such assurances. Consistent with our title
IX regulations and those of other agencies,\389\ OCR declines to revise
Sec. 92.302 to require affirmative notice of exemptions sought by or
granted to recipients under this provision. OCR notes that nothing in
this final rule prevents a recipient from providing public notice of
any such exemption assurances it has sought or received and we
encourage recipients to do so. We recognize that individuals are not
always aware that the health care entities from which they seek care
may be limited in the care they provide, and remain committed to
working with recipients and the public to improve transparency,
clarity, and access to health care through implementation of this rule.
As noted above, OCR is also subject to FOIA, and information may be
released to a requestor or made available for public inspection
consistent with the agency's obligations under that statute and its
implementing regulations.
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\389\ See, e.g., 45 CFR 86.12 (no notice requirement); see,
e.g., 34 CFR 106.12 (Department of Education, same).
---------------------------------------------------------------------------
Comment: Some commenters also criticized the process laid out in
Sec. 92.302 for failing to identify who will evaluate the exemption
requests. One commenter stated that most recipients will likely wait to
raise their religious defenses in litigation, as they see courts as the
only neutral decisionmakers. A handful of commenters also raised
concerns that the 2022 NPRM did not mention OCR's 2019 final rule,
Safeguarding the Rights of Conscience as Protected by Federal Statutes,
84 FR 23170 (May 21, 2019), or its applicability to numerous Federal
statutes protecting religious freedom and conscience in health care. As
a result of this omission, these commenters expressed skepticism about
OCR's ability to apply the regulatory provisions contained in that
rule.
Several commenters also questioned the interaction between the
proposed exemption process and private rights of action. They stated
that while the Sec. 92.302 process would apply to OCR investigations
and enforcement, the provision did not address situations where a
lawsuit has been filed, as there is no across-the-board requirement
that the administrative process be exhausted before going to court.
Commenters assumed that faith-based hospitals likely will be forced to
litigate claims in the courts without the ability to stay proceedings
pending OCR's consideration of their exemption claim--another factor,
they argued, which undermined the usefulness of the proposal.
Response: OCR appreciates commenters' concerns regarding the
process for review. OCR refers commenters to the six specific steps
outlined above detailing what obligations OCR has, and what options are
available to recipients. And as stated previously, OCR is committed to
enforcing all Federal civil rights laws under its purview. While OCR
appreciates comments regarding the 2019 Safeguarding the Rights of
Conscience as Protected by Federal Statutes final rule, as a result of
challenges to its legality, that rule has been vacated.\390\ OCR has
published its final rule on enforcement of religious freedom and
conscience laws. See Safeguarding the Rights of Conscience as Protected
by Federal Statutes, 89 FR 2078 (Jan. 11, 2024). Finally, OCR would not
open or continue an investigation under section 1557 against the
recipient regarding compliance with a provision for which they have
requested an exemption assurance while a temporary exemption under
Sec. 92.302(a) is in effect, or after a final determination is made
that the recipient is entitled to an exemption. While such commenters
are correct that a temporary or final assurance of an administrative
exemption from OCR would not itself preclude any private lawsuit under
section 1557, OCR notes that the recipient could still raise the
relevant Federal conscience or religious freedom law as a possible
defense in judicial proceedings in such private litigation. And in
cases where OCR has assured the recipient an exemption under Sec.
92.302, the recipient could argue that that assurance is evidence that
a Federal religious freedom or conscience law likely applies to the
recipient in any private litigation under this final rule.
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\390\ New York v. HHS, 414 F. Supp. 3d 475, 580 (S.D.N.Y. 2019)
(``Accordingly, as a remedy, the Court vacates the 2019 Rule in its
entirety, pursuant to [the Administrative Procedure Act] Sec.
706(2).''), appeal dismissed without prejudice to reinstatement,
Nos. 19-4254 et al. (2d Cir.); see also Washington v. Azar, 426 F.
Supp. 3d 704 (E.D. Wash. 2019), appeal pending, No. 20-35044 (9th
Cir.); City & Cnty. of San Francisco v. Azar, 411 F. Supp. 3d 1001
(N.D. Cal. 2019), appeal pending, Nos. 20-15398 et al. (9th Cir.).
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Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
[[Page 37661]]
comments received, we are finalizing the provision as proposed in Sec.
92.302, with modifications. First, we are adding a Sec. 92.302(a),
which provide that a recipient may rely on applicable Federal
protections for religious freedom and conscience, and consistent with
Sec. 92.3, application of a particular provision(s) of the part to
specific contexts, procedures, or health care services shall not be
required where such protections apply.
Second, we are revising the process laid out in proposed Sec.
92.302(b) through (d) as follows. We are revising Sec. 92.302(b) to
provide that a recipient that seeks assurance consistent with Sec.
92.302(a) regarding the application of particular provision(s) of the
part to specific contexts, procedures, or health care services may do
so by submitting a notification in writing to the Director of OCR.
Notification may be provided by the recipient at any time, including
before an investigation is initiated or during the pendency of an
investigation, and provides details on what must be submitted in
writing to the OCR Director. We are revising Sec. 92.302(c) to provide
that a temporary exemption from administrative investigation and
enforcement will take effect upon the recipient's submission of the
notification--regardless of whether the notification is sought before
or during an investigation, and then delineates the scope and
application of the temporary exemption. We are revising Sec. 92.302(d)
to provide that if OCR makes a determination to provide assurance of
the recipient's exemption from the application of certain provision(s)
of the part or that modified application of certain provision(s) is
required, the recipient will be considered exempt from OCR's
administrative investigation and enforcement with regard to the
application of that provision as applied to the specific contexts,
procedures, or health care services provided in the written
determination. The determination does not otherwise limit the
application of any other provision of the part to the recipient or to
other contexts, procedures, or health care services.
Third, we are adding Sec. 92.302(e) to provide an administrative
appeal process for recipients subject to an adverse determination of
its request for an assurance of religious freedom and conscience
exemption. Fourth, we are adding Sec. 92.302(f) to provide that a
determination under this section is not final for purposes of judicial
review until after a final decision under 45 CFR part 81.
Procedures for Health Programs and Activities Conducted by Recipients
and State Exchanges (Sec. 92.303)
Section 92.303 proposed the enforcement procedures related to
health programs and activities conducted by recipients and State
Exchanges.
In Sec. 92.303(a), OCR proposed applying 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.
Proposed Sec. 92.303(b) applied Age Act procedures to enforce
section 1557 with respect to age discrimination complaints against
recipients and State Exchanges.
Proposed Sec. 92.303(c) stated 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.
The comments and our responses regarding Sec. 92.303 are set forth
below.
Comment: Many commenters recommended that Sec. 92.303(a)
explicitly recognize claims of discrimination involving multiple
grounds, and suggested adding the language ``or a combination
thereof.''
Response: As discussed in Sec. 92.101, OCR agrees with this
recommendation and we have added ``or any combination thereof''
throughout the regulatory text.
Comment: Commenters generally supported adoption of title VI
procedural provisions with respect to administrative enforcement
actions; however, they noted that OCR proposed to process complaints
alleging discrimination on the basis of age differently given the
adoption of Age Act regulation requirements under Sec. 92.303(b).
These commenters recommended that OCR clarify that for administrative
enforcement, it will treat claims involving multiple bases, such as age
and other protected identities, under the same procedural provisions as
title VI.
Response: The Proposed Rule followed the 2016 Rule's approach to
administrative enforcement procedures for complaints on the basis of
race, color, national origin, sex, and disability, applying the
procedures found in the title VI regulation. The Proposed Rule proposed
to apply the Age Act regulatory procedures to age-based complaints. The
Age Act procedures uniquely contain a requirement that the Department
refer all sufficient complaints to mediation upon receipt; unresolved
complaints will be returned to the Department. 45 CFR 91.43. The
timeline for mediation is generally 60 days, unless a resolution is
reached sooner, or the mediator has extended the time period for no
more than 30 days. Id. at Sec. 91.43(e). The 60-day period counts as
part of the 180 days the Department has to resolve a complaint before a
court action can be filed by the complainant. 47 FR 57850, 57856 (Dec.
28, 1982). The mediation requirement derives entirely from the HHS Age
Act regulations. The Age Act statute does not itself mandate referral
for mediation. It merely directs agencies to publish regulations that
``provide appropriate investigative, conciliation, and enforcement
procedures.'' 42 U.S.C. 6104(a)(4).
In adopting the mediation requirement, the Department stated that
the Age Act regulations offered ``a unique opportunity to try [the]
innovative approach'' to resolution of complaints and committed to
monitoring the effectiveness of the mediation process. 47 FR 57850,
57856 (Dec. 28, 1982). According to the Department's 2021 Age Act
Report, the Department referred 32 complaints for mediation, and two
were successfully mediated (6 percent).\391\ Eight of 21 (38 percent)
cases were successfully mediated in 2020, and eight of 48 (17 percent)
were successfully mediated in 2019.\392\ Thus, the average success rate
of mediation for complaints alleging age discrimination is roughly 18
percent. When a complaint is returned to the Department, it follows the
title VI procedural provisions for investigations and enforcement. 45
CFR 91.47.
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\391\ Annual Report to Congress on Implementation of the Age
Discrimination Act of 1975--Fiscal Year 2021, p. 32, https://www.hhs.gov/sites/default/files/age-act-2021-report.pdf.
\392\ Annual Report to Congress on Implementation of the Age
Discrimination Act of 1975--Fiscal Year 2019, p. 30, https://www.hhs.gov/sites/default/files/age-act-2019-report.pdf; Annual
Report to Congress on Implementation of the Age Discrimination Act
of 1975--Fiscal Year 2020, p. 32, https://www.hhs.gov/sites/default/files/age-act-2020-report.pdf.
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We agree that individuals filing complaints with OCR under any of
the bases for discrimination, including on the basis of age, should not
be subject to unnecessary administrative hurdles. Given that the Age
Act mediation requirement is not required by statute, but rather was an
``innovative'' approach adopted by the Department under its
administrative authority to implement the Age Act, we have determined
that OCR has the authority to not import such a requirement into the
section 1557 procedures. While
[[Page 37662]]
mediation may prove beneficial under certain circumstances, as
reflected through the Department's reporting on Age Act enforcement, it
is not successful in all cases.
Given concerns raised by commenters, the value OCR places on the
efficient and timely resolution of complaints, and the potentially
sensitive nature of complaints raised under section 1557, we revisited
the proposal to require complainants to engage in mandatory mediation.
After review, and in light of these considerations and a desire for
consistency across section 1557 administrative enforcement, we are
revising the regulatory text to strike proposed Sec. 92.303(b), which
would have applied the Age Act procedural provisions to administrative
enforcement actions concerning age discrimination. We are also revising
Sec. 92.303(a) to apply the title VI procedures to all administrative
enforcement actions brought under section 1557.
This means that a complaint filed under section 1557 alleging age
discrimination would not require the complainant to engage in mediation
before OCR can open an investigation and claims alleging multiple bases
of discrimination would be subject to the same enforcement procedures
under the final rule. We note that complainants that wish to engage in
mediation to address a complaint against a recipient or State Exchange
will be provided with the option to do so, as these complaints may also
be addressed under the Age Act, consistent with 45 CFR 91.43.
Comment: Commenters suggested making the OCR complaint process more
straightforward and accessible, especially since individual complaints
remain the primary trigger for investigations and individuals often
file without legal representation. Commenters suggested that the final
rule offer clear, fully accessible complaint mechanisms, including
directions written in plain language, for filing discrimination
complaints. These commenters suggested that complainants should not be
required to parse out how a covered entity perceived them or responded
to differing aspects of their lives. Further, these commenters
recommended that any complaint procedures include resource materials
such as Frequently Asked Questions, process diagrams, and materials
presented in alternative formats, including videos with instructions in
ASL embedded into the website as well as a clear and simple complaint
process for individuals with LEP. One commenter further suggested that
OCR clarify in the final rule that citizenship status is not relevant
to an enforcement process or complaint filing.
One commenter also recommended that the time allowed for filing a
complaint without needing to show good cause be extended from 180 days
to 6 years to account for the postpartum timeline. Another commenter
urged OCR to consider putting the longest deadline on the complaint
filing that it can, consistent with its statutory obligations. This
commenter noted that it often takes people months to realize they have
been discriminated against, decide to do something about that
discrimination, and find out that there are laws against the
discrimination and agencies like OCR where they can file complaints.
Response: OCR appreciates the comments regarding the complaint
process. We understand the complaint filing process may be both
perceived and experienced as challenging, and OCR welcomes suggestions
on making the process more accessible. We currently offer resources on
our website to provide the public with information about the process
for submitting a complaint and what to expect once they have submitted
a complaint to OCR.\393\ In addition, OCR revises its own processes, as
needed. The most recent updates to OCR's Civil Rights Discrimination
Complaint Form and Portal, for example, include providing the form and
portal in fifteen languages other than English, and inclusion of
additional clarity regarding forms of discrimination to report,
including sexual orientation, gender identity, pregnancy, and
discrimination against individuals with LEP.\394\ We consider changes
to the OCR complaint process on an ongoing basis as we strive to
simplify the process and make it more accessible to all.
---------------------------------------------------------------------------
\393\ U.S. Dep't Health & Hum. Servs., Off. for Civil Rts.,
Filing a Civil Rights Complaint, https://www.hhs.gov/civil-rights/filing-a-complaint/index.html.
\394\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Complaint Portal, https://ocrportal.hhs.gov/ocr/cp/complaint_frontpage.jsf; U.S. Dep't of Health & Hum. Servs., Off.
for Civil Rts., Get Help in Other Languages, https://www.hhs.gov/ocr/get-help-in-other-languages/index.html; U.S. Dep't of Health &
Hum. Servs., Off. for Civil Rts., Office for Civil Rights, Civil
Rights and Conscience Complaint form (Expiration Date: Dec. 31,
2025), https://www.hhs.gov/sites/default/files/ocr-cr-complaint-form-package.pdf.
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OCR notes that the requirement that a complaint be filed no later
than 180 days from the alleged discrimination is consistent with the
enforcement mechanisms under title VI, which we adopt herein and have
also been adopted under title IX, section 504, and the Age Act. OCR
will continue to extend the 180-day filing deadline for good cause, as
outlined in the title VI regulation at 45 CFR 80.7(b). Further, to make
this information more widely available, we are reinstating a required
Notice of Nondiscrimination (Sec. 92.10), which includes information
on how to file a complaint with OCR should an individual believe they
were discriminated against.
In response to the comments received, OCR also notes that
citizenship status is not relevant to an enforcement process or
complaint filing; an individual's citizenship or immigration status
does not prevent or alter their ability to file a complaint or OCR's
ability to enforce potential violations.
Comment: Some commenters indicated that OCR should initiate
compliance reviews rather than wait on individual complaints and some
noted that while a simple, accessible complaint system is helpful, it
should not, and cannot be, the only means of enforcement. Commenters
stated that robust enforcement must include agency-initiated oversight,
monitoring, and investigations; and that OCR should proactively review
medical providers' treatment of patients of color for patterns to help
detect bias.
A few commenters stated that incorporating the title VI procedures
in proposed Sec. 92.303(a) means including requirements that covered
entities submit compliance reports and data to OCR and authorizing OCR
to conduct periodic compliance reviews of covered entities. These
commenters argued that OCR is effectively declaring that its
enforcement of these provisions will be based on the presumption that
any business decision made by a covered entity is either intentionally
discriminatory or has an impermissibly discriminatory effect, unless
and until that entity can demonstrate otherwise to OCR's satisfaction.
According to the commenters, this would have the effect of imposing an
expansive, arbitrary, and capricious new regulatory regime.
Response: OCR appreciates the importance of compliance reviews and
robust enforcement. While most OCR investigations are conducted based
on complaints received, OCR also conducts compliance reviews, which may
be based on, for example, news reports or other information received by
OCR.\395\
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\395\ For example, on March 7, 2023, OCR announced that it had
reached a Voluntary Resolution Agreement with Hillsborough County
Fire and Rescue in Florida to improve access to care for communities
of color. OCR initiated a compliance review of Hillsborough County
Right and Rescue in response to public press reports indicating that
its paramedics refused to transport an African American woman to the
hospital because they assumed she could not afford the ambulance
cost due to her race. See U.S. Dep't Health & Hum. Services, Off.
for Civil Rts., HHS Office for Civil Rights Reaches Agreement with
Hillsborough County Fire and Rescue in Florida to Improve Access to
Care for Communities of Color, https://www.hhs.gov/about/news/2023/03/07/hhs-office-for-civil-rights-reaches-agreement-with-hillsborough-county-fire-and-rescue-in-florida.html. In June of
2022, OCR entered into a Voluntary Resolution Agreement with the
University of Southern California (U.S.C.) and Keck Medicine of
U.S.C. (collectively, the ``KMUSC Entities'') resolving a compliance
review of KMUSC Entities' policies and procedures for responding to
sex discrimination complaints made by students, employees, or
patients employed by, or participating in, any KMUSC programs or
activities receiving Federal financial assistance from HHS. See U.S.
Dep't Health & Hum. Servs., Off. for Civil Rts., HHS Voluntary
Resolution Agreement with the University of Southern California
Settles Title IX Compliance Review, https://www.hhs.gov/about/news/2022/06/15/hhs-voluntary-resolution-agreement-with-university-of-southern-california-settles-title-ix-discrimination-complaints.html.
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[[Page 37663]]
OCR disagrees with commenters' position that adopting the
longstanding enforcement procedures of title VI creates a presumption
that a covered entity is discriminating. Nor does the adoption of these
procedures represent a new ``regulatory regime,'' as these procedures
appear in the Department's title VI regulations, which were originally
published in 1964 \396\ and have since been adopted in the Department's
title IX and section 504 regulations. Section 92.303, adopting 45 CFR
80.6 (Compliance information), includes standard requirements related
to civil rights enforcement, including seeking cooperation from
recipients and State Exchanges in obtaining compliance; providing
assistance and guidance to assist recipients and State Exchanges reach
voluntary compliance; requiring records maintenance by recipients and
State Exchanges so that they may demonstrate compliance with the
conditions of their receipt of Federal funds; requiring access to
pertinent records as needed to determine compliance; and sharing
information with the public regarding protections against
discrimination. As with all of its investigations, including compliance
reviews, OCR acts as a neutral factfinder and does not presume
discrimination by the covered entity.
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\396\ 29 FR 16298, 16301-03 (Dec. 4, 1964).
---------------------------------------------------------------------------
Comment: Some commenters recommended that OCR consider creating a
searchable database of complaints and provide status updates that
clearly indicate where in the process a complaint stands. Commenters
also noted that OCR should shorten the time between filing a complaint
and resolution. They noted that lengthy timelines for resolution have
been detrimental, as advocates are reluctant to file knowing the
duration of an investigation, and covered entities feel less urgency to
comply. Some commenters noted that an ongoing deterrent to filing
administrative complaints with OCR is the lack of a mandatory response
deadline from OCR in title VI procedures. These commenters recommended
implementing a 90-day deadline for OCR to resolve most section 1557
complaints, and a 120-day deadline for ``more involved'' section 1557
complaints.
Response: OCR appreciates commenters' recommendation to create a
searchable database of complaints, and will take that under advisement,
though we cannot commit to doing so at this time. OCR works with finite
resources to address complaints as quickly and efficiently as possible
and will continue to do so. Title VI procedures require a prompt
investigation whenever information indicates possible noncompliance.
OCR intends to follow these enforcement procedures and promptly address
and resolve outstanding compliance failures. Because each potentially
discriminatory action involves unique facts and circumstances that must
be independently investigated on a case-by-case basis before OCR can
determine whether a challenged action is considered discriminatory, we
decline to add a mandatory response deadline as requested by
commenters.
Comment: One commenter recommended that OCR create a separate
portal for complaints related to obstetric violence and obstetric
racism.
Response: OCR currently uses one portal for all civil rights
complaints. The portal allows complainants to select the ground(s)
under which they believe they were discriminated against to help ensure
their complaints are fully reviewed and considered by OCR.
Comment: Some commenters suggested merging proposed Sec. Sec.
92.303 and 92.304 to help reduce confusion among complainants.
Response: While we appreciate the need to have clarity when filing
complaints, maintaining two separate sections is necessary given that
there are different procedures for OCR to follow depending on whether
the complaint is against the Department itself, or a recipient or State
Exchange. However, for the sake of additional clarity, OCR will revise
Sec. 92.303(a) to parallel Sec. 92.304,
Comment: Some commenters recommended OCR include a provision in
Sec. 92.303 expressly stating that if OCR does not have jurisdiction
over a complaint, it will refer it to the appropriate office or agency.
Response: Section 92.304 adopts the compliance procedures found in
OCR's federally conducted section 504 implementing regulation, which
includes a provision requiring OCR to make reasonable efforts to refer
a complaint over which it does not have jurisdiction to the appropriate
Federal Government agency. 45 CFR 85.61(e). There is no corresponding
provision in the title VI procedures, which are adopted at Sec. 92.303
and are applicable to recipients and State Exchanges. However, OCR's
practice is to refer such complaints, and we believe this is important
to reflect this in regulatory text. We have included a new provision,
replacing the former age-discrimination related provision at proposed
Sec. 92.303(b), that reads: ``If OCR receives a complaint over which
it does not have jurisdiction, it shall promptly notify the complainant
and shall make reasonable efforts to refer the complaint to the
appropriate Federal Government entity.''
A Comment: Some commenters recommended that any enforcement
mechanism include monitoring, reporting, and ``actual penalties'' or
fines.
Response: We appreciate the need for strong enforcement mechanisms
to ensure compliance with section 1557. The enforcement mechanisms
incorporated into the rule allow for investigations based on both
complaints and OCR-initiated compliance reviews. Voluntary Resolution
Agreements and Settlement Agreements resulting from investigations
generally include a monitoring period and reporting requirement to
ensure ongoing compliance. If a recipient or State Exchange does not
come into voluntary compliance and is found in violation of section
1557, OCR can take compliance action by either initiating fund
termination proceedings under 45 CFR 80.8 or by any other means
authorized by law, including referral to DOJ for enforcement
proceedings.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, we are finalizing the provisions as proposed in
Sec. 92.303, with modifications. We are revising Sec. 92.303(a) to
read ``. . . administrative enforcement actions concerning
discrimination on the basis of race, color, national origin, sex, age,
disability, or any combination thereof . . .'' This language applies
the same procedural provisions to administrative enforcement actions
under section 1557
[[Page 37664]]
regardless of the basis of alleged discrimination, acknowledges that
discrimination experienced by individuals may involve multiple bases,
and corrects a scrivener's error (an unnecessary placement of the word
``discrimination'' after ``disability''). We are also revising Sec.
92.303(a) to parallel Sec. 92.304, to now provide that the procedural
provisions applicable to title VI apply with respect to administrative
enforcement actions against health programs and activities of
recipients and State Exchanges concerning discrimination on the basis
of race, color, national origin, sex, age, and disability
discrimination under section 1557 or the part. These procedures are
found at 45 CFR 80.6 through 80.11 and part 81 of the subchapter.
Additionally, we are replacing the text at proposed Sec. 92.303(b)
with new language stating: ``If OCR receives a complaint over which it
does not have jurisdiction, it shall promptly notify the complainant
and shall make reasonable efforts to refer the complaint to the
appropriate Federal Government entity.''
Procedures for Health Programs and Activities Administered by the
Department (Sec. 92.304)
In Sec. 92.304, OCR addressed procedures for all claims of
discrimination against the Department under section 1557 or the part,
as set forth in Sec. 92.304(a).
Section 92.304(b) proposed making the existing procedures under the
section 504 federally conducted regulation at 45 CFR 85.61 and 85.62
applicable to all such claims under Section 1557 for all protected
bases (i.e., race, color, national origin, sex, age, and disability).
Section 92.304(c) proposed requiring the Department to provide OCR
access to information relevant to determining compliance with section
1557 or the part.
Section 92.304(d) proposed prohibiting the Department from
retaliating against an individual or entity for the purpose of
interfering with any right secured by section 1557 or the part, or
because such individual or entity has participated in an investigation,
proceeding, or hearing under section 1557 or the part.
The comments and our responses regarding Sec. 92.304 are set forth
below.
Comment: Some commenters recommended that this section explicitly
recognize claims of discrimination involving multiple bases, and
suggested amending Sec. 92.304(a) to add ``or a combination thereof.''
Some commenters recommended providing clear procedures for the
administrative enforcement of such intersectional claims.
Response: OCR agrees that including this language is consistent
with the changes we have made throughout the text regarding claims of
discrimination involving multiple bases and accepts this proposal with
a minor modification, so that the rule reads ``of any combination
thereof.'' Further, OCR appreciates the recommendation for providing
clear procedures for the administrative enforcement of intersectional
claims. As stated in Sec. 92.301, administrative complaints under
section 1557 alleging multiple grounds of discrimination are now
subject to a single administrative process.
Comment: Commenters on Sec. 92.304(d) supported its prohibition on
retaliation by the Department, noting that this provision shows a
commitment to preventing discrimination at all levels and ensuring a
path to rectifying grievances.
Response: OCR appreciates the support for this provision and, as
stated in the preamble, we think it is important to include because
individuals should not face retaliation for asserting their civil
rights or raising concerns regarding discrimination being experienced
by others.
Comment: Some commenters encouraged OCR to be as proactive as
possible in enforcing the regulations with respect to the Department's
programs.
Response: OCR appreciates the need for proactive enforcement and
proactive technical assistance. We will continue working with the
Department components in providing technical assistance and assisting
them in helping to resolve compliance issues with section 1557.
Summary of Regulatory Changes
For the reasons set forth in the Proposed Rule and considering the
comments received, OCR is finalizing the provisions as proposed in
Sec. 92.304, with modification. We are revising Sec. 92.304(a) and
(b) to read ``. . . discrimination on the basis of race, color,
national origin, sex, age, disability, or any combination thereof . . .
,'' consistent with edits made at Sec. Sec. 92.101(a)(1), 92.207(a)
and (b)(1) and (2), and 92.303(a). In addition, as noted above, for
clarity, we are revising Sec. 92.304(b) to parallel Sec. 92.303 to
now provide that the procedural provisions applicable to section 504 at
45 CFR 85.61 and 85.62 shall apply with respect to administrative
enforcement actions against the Department, including Federally-
facilitated Exchanges, concerning discrimination on the basis of race,
color, national origin, sex, age, or disability under section 1557 or
the part. Also, where the 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.
III. Change in Interpretation--Medicare Part B Funding Meets the
Definition of Federal Financial Assistance; Responses to Public Comment
The Department's longstanding position has been that Medicare Part
B (``Part B'') funding does not meet the definition of ``Federal
financial assistance'' for the purpose of title VI, title IX, section
504, the Age Act, and section 1557. See, e.g., 81 FR 31375, 31383 (May
18, 2016). In the 2022 NPRM, we proposed to change that position after
evaluating the Part B program and the definition of ``Federal financial
assistance'', such that Part B funds will be considered Federal
financial assistance when received by providers and suppliers.
The Department sought comment on the impact that this change in
position may have on recipients subsidized only by Part B funds that do
not receive any other form of Federal financial assistance from the
Department. We also invited comment on the amount of time that should
be allowed for recipients of Part B funds to come into compliance with
the applicable statutes and their implementing regulations. We also
sought comment on what resources the Department can provide to assist
newly covered entities in coming into compliance.
The comments and our responses regarding this change in
interpretation are set forth below.
Comment: Some commenters objected to the proposal. These commenters
claimed that interpreting Part B as meeting the definition of ``Federal
financial assistance'' would reduce access to care because forcing
these providers to implement new requirements will discourage them from
participating in federally funded health care programs. Other
commenters who opposed this interpretation stated that Part B does not
meet the definition of ``Federal financial assistance'' because the
program requires participants to pay monthly premiums based on income.
In this way, commenters maintained, Part B is merely a private health
insurance plan for individuals with low incomes, and is not equivalent
to a Federal welfare program. A few commenters discussed that including
Part B among the programs to which section 1557 applies is a radical
change to what
[[Page 37665]]
qualifies as Federal financial assistance, and that such a change will
affect other civil rights laws.
Response: The Department's change in interpretation regarding Part
B does not alter, change, or expand the definition of ``Federal
financial assistance.'' As stated in the 2022 NPRM, the Department is
revising its position regarding whether Part B payments constitute
Federal financial assistance under the longstanding definition of
``Federal financial assistance'' in regulations implementing section
1557 and the four statutes referenced in section 1557: title VI, title
IX, section 504, and the Age Discrimination Act. 87 FR 47828. After
evaluating the definition of ``Federal financial assistance,'' the
Department has concluded that Part B funds meet that definition. While
we disagree that this change in interpretation changes the definition
of ``Federal financial assistance,'' we do note that this change means
that Part B payments are considered Federal financial assistance with
respect to title VI, title IX, section 504, and the Age Discrimination
Act, in addition to section 1557.
Moreover, the Department disagrees that Part B is the equivalent of
private health insurance and therefore is not Federal financial
assistance. Part B confers a benefit or subsidy on the recipient--
namely, financial assistance to the provider in exchange for providing
health care services. As discussed in the 2022 NPRM, ``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.'' 87 FR 47890. The Federal Government,
through Part B, offers providers a reliable source of payment for
services given to eligible patients who otherwise would go without
care. Although Part B enrollees may pay premiums to receive coverage,
the Federal Government covers half of the cost of Part B benefits.
Thus, the fact that enrollees may pay for a portion of their coverage
does not change the fact that providers receive Federal financial
assistance through the program. In this way, Part B is no different
than Medicare Part A, which also offers financial assistance to
providers and which has long been considered Federal financial
assistance. We note, however, that private health insurance may be
subject to this rule when a health insurance issuer receives Federal
financial assistance for such coverage. For instance, issuers may
receive Federal financial assistance through receipt of advance
payments of the premium tax credit or cost-sharing reductions for
qualified health plans, which are private health insurance plans sold
on the Exchanges. Further, when a recipient health insurance issuer is
principally engaged in the provision or administration of health
insurance coverage or other health-related coverage as set forth under
the definition of ``health program or activity'' at Sec. 92.4, all of
the issuer's operations are covered, including its other private health
insurance coverage, such as coverage sold off the Exchange.
OCR is also unpersuaded by the argument that the Department's
change in interpretation will reduce access to care by leading to
physician disenrollment from Medicare participation or decreased
participation in other federally funded government programs. Indeed, we
are unaware of any evidence that supports this concern and commenters
did not provide any. As stated in the 2022 NPRM, many providers who
receive payments through Part B are already subject to section 1557 and
the four civil rights laws referenced in section 1557 through receipt
of other Federal financial assistance. 87 FR 47890.
For the reasons provided in the NPRM and restated here, the
Department respectfully disagrees with commenters and reiterates its
position that funds provided via the current Part B program meet the
longstanding definition of ``Federal financial assistance''.
Comment: An overwhelming number of commenters supported the change
in interpretation, the result of which is that the Part B funds will be
considered Federal financial assistance. Many groups commented that
applying section 1557 to Part B will help address past discrimination.
For example, commenters discussed that excluding Part B from a Federal
financial assistance designation exempted individual providers from any
obligation to comply with the Civil Rights Act of 1964. This exemption
of the Part B program from title VI's nondiscrimination requirements
allowed doctors in many states to continue providing segregated health
care services. Commenters stated that failing to consider Part B
payments as Federal financial assistance created confusion for patients
about whether civil rights laws applied to their individual health
providers--many of whom refused to serve individuals on the basis of
their race or national origin because title VI did not apply to them.
Therefore, commenters suggested that discriminatory history warrants
the Department's reassessment of whether Part B payments meet the
definition of ``Federal financial assistance''. They also note that
this change will align Part B with other portions of the Medicare
program and bring uniformity across all Medicare providers, increasing
access to quality health care.
Other commenters explained that many of Part B providers already
receive other forms of Federal financial assistance, such that this
change in interpretation will not subject them to new obligations. Some
commenters stated that all providers enrolled in the Part B program are
recipients of Federal financial assistance--regardless of whether they
are ``participating'' or ``non-participating'' providers--because even
those designated as ``non-participating'' agree to provide Medicare-
subsidized health services to Part B enrollees.
Many other supportive commenters noted that because funds received
under Medicare Part A and Part B are fundamentally similar and Medicare
Part A payments have long been considered Federal financial assistance,
it is reasonable for the Department to similarly consider Part B
payments as Federal financial assistance. Therefore, the commenters
argue, considering Part B payments to be Federal financial assistance
will allow individuals additional options for bringing discrimination
claims against discriminatory conduct in all health care settings.
Response: OCR appreciates commenters' views on the Department's
change in interpretation regarding whether Part B payments constitute
Federal financial assistance as defined by our civil rights
regulations. The Department agrees with commenters that because Part B
payments, like those of Medicare Part A, are Federal funds directly or
indirectly received by providers, they squarely meet the definition of
``Federal financial assistance''. This position provides uniformity
across the Medicare programs and will not only help address patient
confusion regarding the funding streams of their respective Medicare
programs, but also ensures that the Department is applying the
definition of ``Federal financial assistance'' consistently across all
of our federally funded programs.
The Department agrees that because many recipients of Part B funds
are already recipients of some other form of Federal financial
assistance, this change will not impose excessive burdens on those
covered entities. For those newly covered entities, however, we are
providing a delayed applicability date as discussed below.
[[Page 37666]]
Comment: Many other commenters expressed the view that this change
in position by the Department reflects the evolution of how the Part B
program operates today. Commenters explained that while Part B once
served as contracts of insurance for those who qualified, today,
individual providers directly bill and receive payment from the Federal
Government itself.
Response: The Department acknowledges commenters' point that the
current manner in which the Part B program is administered is a factor
in our changed view on whether Part B funds meet the definition of
``Federal financial assistance''. As the commenters noted, a majority
(\2/3\) of providers enrolled in Part B bill and are paid directly by
the Medicare program. 87 FR 47889. However, this is not solely
determinative regarding the change in interpretation. As noted in the
2022 NPRM, under Grove City College v. Bell, 465 U.S. 555, 569 (1984),
Federal funds are Federal financial assistance regardless of whether
they are provided directly by the Federal Government to an entity or
are provided initially to beneficiaries (i.e., program participants)
for the specified purpose of assisting with payment for services.
Comment: Several commenters stated that this change in position
will increase equity in access to quality health care for individuals
with LEP, immigrants, and communities of color, as these groups are
more likely to participate in Part B. Other commenters expressed the
view that this interpretation allows the Department to align Part B
providers' nondiscrimination obligations to Medicare Part A, which will
result in better care for individuals with disabilities and will
eliminate confusion for older adults who cannot determine whether their
Part B provider receives any other type of Federal financial
assistance. Other commenters stated that this will offer significant
relief for older patients, individuals with disabilities, and LGBTQI+
adults by providing the same protections and rights regardless of the
nature of the Medicare provider or the service they are receiving.
These patients will no longer have to determine whether they are
eligible for both Medicare and Medicaid, or whether they have Medicare
or Medicaid, in order to assess what nondiscrimination protections they
are afforded. A few commenters expressed the view that this will be
particularly helpful for enrollees who rely on small specialty
providers for care, such as medical equipment suppliers, that receive
only Part B and no other form of Federal financial assistance. Several
other commenters also explained that because many Medicare providers
also serve people with other forms of health coverage, including
private insurance, this change will increase access to quality health
care for underserved communities who face disproportionate
discrimination and barriers.
Response: The Department appreciates these comments and generally
agrees that bringing all Medicare programs in line with other Federal
financial assistance programs will bring about better health outcomes
and increase equity in access to care. This position is also supported
by the similarities across the Medicare programs and eliminates an
inconsistency in the application of the definition of ``Federal
financial assistance'' that the Department has determined is no longer
justifiable.
Comment: A few commenters suggested that the Department should have
a delayed date for when the revised interpretation regarding Part B
payments as Federal financial assistance becomes effective. Some
suggested at least 180 days and up to 365 days for newly covered
providers to reach compliance for those practices that have not been
subject to these requirements in the past. Several commenters stated
that newly covered entities will need sufficient time to implement
appropriate procedures, such as having a one-year applicability date or
a safe-harbor compliance window of at least 6 months. However, one
commenter expressed that the Department should impose the same
implementation timeline for all covered entities, given that, in their
view, very few entities will be providers who are not already Federal
financial assistance recipients. This commenter explained that
additional time is not necessary because OCR is also providing entities
with technical assistance to reach compliance.
Response: The Department appreciates commenters' concerns and has
amended the applicability date to give newly covered recipients
sufficient time to come into compliance with civil rights obligations,
as described below in the ``Summary of Changes.'' As this new
designation of Part B applies to all Federal financial assistance-based
civil rights statutes enforced by the Department, to the extent covered
entities require assistance, OCR will provide adequate support.
Notice of Interpretation and Dates
A. Notice of interpretation.
The Department is finalizing its interpretation that Medicare Part
B (``Part B'') funding meets the definition of ``Federal financial
assistance'' for the purpose of title VI, title IX, section 504, the
Age Act, and section 1557.
B. Effective date.
This interpretation is effective upon its publication in the
Federal Register.
C. Applicability date.
The Department recognizes that that there are some recipients that
do not receive any Federal financial assistance other than Part B funds
and that these recipients be newly required to comply with section 1557
and other Federal civil rights laws enforced by OCR. The Department
acknowledges that these recipients will require time to come into
compliance as a result of this change in position. Therefore, while
this revised interpretation is effective upon publication in the
Federal Register, it will have a one-year delayed applicability date.
Thus, compliance by entities whose Federal program participation has
been limited to Part B must be in compliance with title VI, title IX,
section 504, the Age Act, and section 1557 no later than May 6, 2025.
An Assurance of Compliance, as required by 45 CFR 92.5, must be filed
with the Department by entities whose Federal program participation has
been limited to Medicare Part B no later than May 6, 2025. This can be
completed via OCR's Assurance of Compliance portal at https://ocrportal.hhs.gov/ocr/aoc/instruction.jsf. Similarly, if such a
recipient accepts a form of Federal financial assistance other than
Part B prior to May 6, 2025, they will be required to complete an
Assurance of Compliance at that time, consistent with section 1557 and
the other Federal civil rights laws enforced by OCR.
IV. CMS Amendments
In the 2022 NPRM, the Department proposed clarifying CMS provisions
that govern Medicaid and CHIP; PACE; health insurance issuers,
including issuers providing 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 into Exchange coverage 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. The
Department sought comments on CMS' proposal to explicitly mention only
gender identity and sexual orientation in its amendments, while
understanding that
[[Page 37667]]
discrimination on the basis of sex stereotypes, sex characteristics,
and pregnancy or related conditions is also prohibited sex
discrimination.
We are clarifying and emphasizing our intent that if any provision
of this final rule is held to be invalid or unenforceable by its terms,
or as applied to any person or circumstance, or stayed pending further
action, it shall be severable from this final rule, and from rules and
regulations currently in effect, and not affect the remainder thereof
or the application of the provision to other persons not similarly
situated or to other, dissimilar circumstances. Through this rule, we
adopt provisions that are intended to and will operate independently of
each other, even if each serves the same general purpose or policy
goal. Where a provision is necessarily dependent on another, the
context generally makes that clear.
Comment: The majority of commenters on the proposed CMS amendments
in the 2022 NPRM supported the proposal to explicitly identify and
recognize discrimination on the basis of sexual orientation and gender
identity as prohibited types of sex discrimination. However, many of
the commenters noted that the language in the CMS amendments did not
match the language explaining what constitutes sex discrimination in
the proposed section 1557 implementing regulation (proposed 45 CFR
92.101(a)(2)). Commenters encouraged the agency to adopt the language
in proposed Sec. 92.101(a)(2). Specifically, those commenters
suggested that the CMS amendments should revise the term ``sex'' to
``sex (including discrimination on the basis of sex characteristics,
including intersex traits; pregnancy or related conditions; sexual
orientation; gender identity; transgender status; and sex
stereotypes)'' rather than ``sex (including sexual orientation and
gender identity)'' as proposed for the various CMS regulations.
Commenters argued that adopting the language from Sec. 92.101(a)(2) in
the CMS amendments would avoid confusion and ensure consistency of
implementation and enforcement among the nondiscrimination protections
in the CMS amendments and section 1557. In many contexts, CMS program
regulations are more visible to some providers, patients, patient
advocates, and other stakeholders than section 1557 requirements and
are more readily translated into institutional policy, training, and
patient awareness. Commenters asserted that the Department having a
consistent description of sex discrimination would improve consistency
across Department regulations, further the health and safety of program
beneficiaries, and protect them from discrimination in health care. One
commenter emphasized that a statement in the 2022 NPRM that CMS
understands that discrimination on the basis of sex stereotypes, sex
characteristics, and pregnancy or related conditions is prohibited sex
discrimination, without the inclusion of such language in the
regulatory text, provides inadequate notice to entities required to
comply with the CMS amendments.
Response: The Department is finalizing the proposed amendments to
the CMS regulations, with a revision to the description of sex
discrimination to conform to the language in 45 CFR 92.101(a)(2). We
appreciate that so many commenters made this suggestion and raised
important issues concerning avoiding confusion, ensuring consistent
implementation, and providing greater clarity for compliance and
enforcement. In the Proposed Rule, CMS noted in the preamble that it
understands that sex discrimination includes discrimination based on
sex stereotypes, sex characteristics, including intersex traits, and
pregnancy or related conditions, but limited the explicit mention in
the regulatory text to gender identity and sexual orientation, sought
comments. 87 FR 47891. The Department agrees with commenters that the
amendments in the regulation should reflect CMS' intended
interpretation of sex discrimination to avoid confusion for regulated
entities and to better address the barriers to obtaining health care,
including those faced by LGBTQI+ people, that CMS noted in the Proposed
Rule. As there are entities that must comply with both CMS
nondiscrimination provisions and section 1557, adopting identical
language will ensure consistency across the policies and requirements
applicable to entities subject to all of the provisions. As finalized,
these CMS regulations provide that discrimination based on ``sex''
includes discrimination based on sex characteristics, including
intersex traits; pregnancy or related conditions; sexual orientation;
gender identity; and sex stereotypes. The list in the regulation text
is not an exhaustive one that outlines all the ways (or the only ways)
that discrimination can be based on sex but, rather, it only identifies
examples; CMS interprets these regulations accordingly. However,
nothing in this rule impedes regulated entities from taking
nondiscriminatory actions based on current medical standards and
evidence, such as individualized and nondiscriminatory decisions based
on current medical standards and evidence about the timing or type of
protocols appropriate for care. The rule does not (and cannot) require
a specific standard of care or course of treatment for any individual,
minor or adult.
Summaries of regulatory changes are outlined below, along with
responses to comments. In the following sections, for brevity, all
references to ``sex discrimination'' or ``discrimination on the basis
of sex'' mean ``discrimination based on sex (including discrimination
on the basis of sex characteristics, including intersex traits;
pregnancy or related conditions; sexual orientation; gender identity,
including transgender status; and sex stereotypes).''
A. Medicaid and Children's Health Insurance Program (CHIP)
In 42 CFR 438.3(d)(4) and 438.206(c)(2) (which apply to CHIP
managed care through existing cross-references in Sec. Sec.
457.1201(d) and 457.1230(a)), we proposed to restore regulatory text to
prohibit Medicaid and CHIP managed care plans, which include 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 to promote access and delivery of services in a
culturally competent manner to all beneficiaries regardless of sexual
orientation or gender identity. Such text was finalized as part of
Sec. Sec. 438.3(d) and 438.206(c)(2) in the Medicaid and CHIP managed
care final rule published in the Federal Register on May 6, 2016 (2016
Medicaid and CHIP Rule), 81 FR 27498, but was removed as part of the
Department's second section 1557 rulemaking (2020 Rule), 85 FR 37160,
37219-37220.
Similarly, in 42 CFR 440.262, for fee-for-service Medicaid
programs, we proposed to restore regulatory text to require States to
promote access and delivery of services in a culturally competent
manner to all beneficiaries regardless of sex, including sexual
orientation or gender identity. Again, the text was finalized as part
of Sec. 440.262 in the 2016 Medicaid and CHIP Rule but the references
to sexual orientation and gender identity were removed by the 2020
Rule. We also proposed to change ``unique'' in 42 CFR 440.262 to
``individualized'' to more accurately reflect Medicaid's goal of
providing person-centered care. Finally, we proposed to incorporate 42
CFR 440.262 into CHIP regulations through a cross-reference at 42 CFR
457.495(e),
[[Page 37668]]
ensuring alignment across fee-for-service Medicaid and CHIP programs.
The comments received on these proposals and our responses are set
forth below.
Comment: We received many comments in support of the reinstatement
of prohibitions against discrimination based on sexual orientation and
gender identity in Medicaid and CHIP. Commenters stated that restoring
the regulation text at 42 CFR 438.3(d)(4), 438.206(c)(2), and 440.262
(and therefore in Sec. Sec. 457.1201(d) and 457.1230(a)) would promote
access to care and the delivery of services in a culturally competent
manner, strengthen the Department's commitment to increasing equity,
and address discrimination in health programs and activities that can
lead to disparate health outcomes.
Response: We appreciate the support for our proposals and believe
finalizing revisions to these provisions will be an essential step in
promoting culturally competent care that improves access, quality of
care, and ultimately health outcomes.
Comment: One commenter that asked CMS to adopt the more detailed
description of ``sex discrimination'' in proposed Sec. 92.101(a)(2)
pointed out that CMS program rules provide different compliance
mechanisms--including prospective as well as complaint-based
mechanisms--that complement section 1557's fundamental but essentially
retrospective, complaint-based enforcement scheme.
Response: We appreciate the commenter raising this important
perspective. There are prospective and retrospective compliance
mechanisms reflected as State and managed care plan responsibilities in
the Medicaid managed care regulations at 42 CFR part 438. Some
provisions explicitly address requirements that must be included in
managed care plan contracts and others stipulate State
responsibilities. A provision that particularly reflects State
responsibilities for proactively monitoring their managed care programs
to ensure compliance with Federal regulations is 42 CFR 438.66, which
requires States to have a monitoring system for all Medicaid managed
care programs that addresses all aspects of the program including the
performance of each managed care plan. This provision also requires
States to use the data collected from their monitoring activities to
improve their program's performance. This example of a prospective and
retrospective activity requirement demonstrates how the Medicaid
managed care regulations may help states and their managed care
programs complement OCR's enforcement actions related to the
prohibition of discrimination by providing for more timely monitoring
and enforcement of discrimination prohibitions. Consistent regulation
text about what sex discrimination means in this context--specifically,
it includes discrimination on the basis of sex characteristics,
including intersex traits; pregnancy or related conditions; sexual
orientation; gender identity; and sex stereotypes--will maximize the
effect of these benefits.
In addition, we believe it is critical to ensure consistency in the
application of nondiscrimination requirements between Medicaid managed
care and fee-for-service programs. Under section 1902(a)(19) of the
Social Security Act, states must provide for such safeguards as may be
necessary to assure access to care and services in a manner consistent
with simplicity of administration and the best interest of
beneficiaries. A Medicaid fee-for-service regulation (at 42 CFR
440.262) clarifying the meaning of the term ``sex'' in this context,
particularly when that regulation is consistent with 42 CFR 438.3(d)(4)
and 438.206(c)(2) facilitates simplicity in administration of
nondiscrimination requirements and ensures the best interests of the
beneficiaries are met across Medicaid delivery systems for all Medicaid
beneficiaries. As we noted in the NPRM, the best interest of
beneficiaries is appropriately met when access to care and services are
provided in a non-discriminatory manner. A consistent approach on this
issue will help protect beneficiaries from discrimination, avoid
confusion, and provide for simplicity in administration of State
Medicaid programs. To this end, we believe the reference to ``sex'' at
42 CFR 440.262 should be consistent with 42 CFR 438.3(d)(4) and
438.206(c)(2).
For this reason and those stated above, we are finalizing the
proposed amendments to 42 CFR 438.3(d)(4), 438.206(c)(2), and 440.262
with revisions to make the discussions of ``sex'' in them consistent
with 45 CFR 92.101(a)(2). In 42 CFR 438.3(d)(4) (and therefore Sec.
457.1201(d)), we also are finalizing revisions to improve the
readability of the provision by replacing some of the commas with
semicolons and moving ``disability'' after ``national origin.'' We have
also removed unnecessary parentheses in 42 CFR 438.3(d)(4),
438.206(c)(2), and 440.262.
Comment: One commenter asserted that the Department based the
Proposed Rule on general provisions of the Social Security Act
requiring that health assistance be provided in the ``best interest of
beneficiaries'' (for Medicaid programs) and that the statute cited by
the Department does not indicate Congressional intent related to
prohibiting discrimination.
Response: The Department undertook 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, and to better
address issues of discrimination that contribute to negative health
interactions and outcomes. We believe aligning the Medicaid and CHIP
regulations in 42 CFR parts 438, 440, and 457, subpart L, with the
section 1557 regulations is critical to fulfilling the Department's
mission of pursuing health equity and protecting public health. 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.
CMS possesses statutory authority under section 1902(a)(4) of the
SSA (codified at 42 U.S.C. 1396a(a)(4)), 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 sex 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. For these reasons, we disagree with
the commenter and continue to assert that adopting protection against
discrimination to address disparities and, ultimately, health outcomes
is within the authority granted to CMS by the Act.
[[Page 37669]]
Comment: One commenter stated that the proposed regulation text
would prohibit physicians or other health professionals from
categorically declining to provide gender-affirming treatments due to
their religious or moral beliefs guaranteed them under the First
Amendment to the U.S. Constitution and could require them to provide
services and treatment procedures related to gender-affirming care that
they object to performing.
Response: These regulations do not require the provision of any
specific services. These regulations are neutral, generally applicable,
and do not violate the Free Exercise Clause of the First Amendment.
These regulations do not target religiously motivated conduct, but
rather, are intended to prohibit sex discrimination generally in order
to improve health outcomes for the LGBTQI+ community and fulfill the
statutory command of the ACA to prohibit discrimination and remove
unreasonable barriers to care. As noted previously in this rule,
conduct does not constitute a violation of this rule's prohibition on
sex discrimination if there is a legitimate, nondiscriminatory reason
for the action. Also, HHS will respect religious freedom and conscience
protections in Federal law, particularly with regard to the provision
of certain health-related services. For example, when enforcing its
nondiscrimination regulations, HHS will comply with laws protecting the
exercise of conscience and religion, including RFRA (42 U.S.C. 2000bb
through 2000bb-4) and all other applicable legal requirements. Nothing
in the nondiscrimination protections at 42 CFR 438.3(d)(4),
438.206(c)(2), and 440.262 (which apply to CHIP managed care through
existing cross-references in Sec. Sec. 457.1201(d) and 457.1230(a) and
CHIP fee-for-service through a new cross-reference at Sec.
457.495(e)), displaces those protections. In enforcing the
nondiscrimination provisions in the corresponding CMS regulations, the
Department will comply with laws protecting the exercise of conscience
and religion, including the Religious Freedom Restoration Act (42
U.S.C. 2000bb through 2000bb-4) and all other applicable legal
requirements. Finally, we note that physician licensing and discipline
are outside the scope of this rulemaking.
Summary of Regulatory Changes
After consideration of the public comments, we are finalizing 42
CFR 438.3(d)(4), 438.206(c)(2), and 440.262 (which apply to CHIP
managed care through existing cross-references in Sec. Sec.
457.1201(d) and 457.1230(a)) with revisions to specify that
discrimination based on ``sex'' includes discrimination on the basis of
sex characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes.
Similarly, where these regulations require actions to be taken
regardless of sex, that includes actions regardless of sex
characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes.
We are also finalizing the change of ``unique'' to ``individualized''
in 42 CFR 440.262 as proposed.
B. Programs of All-Inclusive Care for the Elderly (PACE)
In 42 CFR 460.98(b)(3), CMS proposed to add sexual orientation and
gender identity to the list of characteristics that may not serve as a
basis for discrimination against a PACE participant. Additionally, in
42 CFR 460.112, we proposed to add gender identity to the list of
characteristics that may not serve as a basis for discrimination
against a PACE participant. This PACE provision is applicable one year
after the effective date of this final rule.
Comment: CMS received numerous comments supporting our changes to
both provisions.
Response: CMS thanks the commenters for supporting these important
changes that will serve to protect CMS' beneficiaries.
Comment: Several commenters did not support CMS' proposal to add
sexual orientation and gender identity to the list of characteristics
that may not serve as a basis for discrimination against a PACE
participant. Some commenters objected to the protections against
discrimination on the basis of gender identity, in particular. Some
commenters, believing that the proposal requires coverage of gender-
affirming care, stated that the Department can adequately protect
people from discrimination without mandating this coverage.
Response: This rule does not require entities to cover any
particular procedure or treatment. We clarify that, in finalizing the
prohibition against discrimination on the basis of sex, the Department
is not mandating that PACE organizations include coverage for any
particular item or service not already covered. Rather, amending these
sections to clarify discrimination on the basis of sex as including sex
characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes
will better ensure that all individuals are treated fairly in their
access to health care. Without protection from such sex discrimination,
transgender individuals may face barriers or be denied medically
necessary services that are classified as covered under PACE and made
available to other enrolled individuals. These amendments will better
clarify nondiscrimination protections for all individuals, while also
addressing existing disparities for LGBTQI+ individuals seeking health
care. For the reasons discussed here and in the preamble to the
Proposed Rule, CMS believes it is important to ensure all PACE
participants are protected against unlawful discrimination of any kind,
including discrimination based on sex characteristics, including
intersex traits; pregnancy or related conditions; sexual orientation;
gender identity; and sex stereotypes. Therefore, we are finalizing
these revisions.
Summary of Regulatory Changes
We are finalizing the regulatory language with modifications based
on comments received. Specifically, we are revising the reference to
sex to include additional detail explaining that the reference to
``sex'' includes sex characteristics, including intersex traits;
pregnancy or related conditions; sexual orientation; gender identity,
including transgender status; and sex stereotypes.
C. Insurance Exchanges and Group and Individual Health Insurance
Markets
In the HHS Notice of Benefit and Payment Parameters for 2023
Proposed Rule (2023 Payment Notice NPRM),\397\ the Department proposed
amendments to the regulations applicable to Exchanges, QHPs, and
certain issuers to prohibit discrimination based on sexual orientation
and gender identity. The amendments were similar to those proposed in
the 2022 NPRM. Those proposed amendments were not finalized in the
Notice of Benefit and Payment Parameters for 2023 final rule published
on May 6, 2022,\398\ because the Department determined that it would be
most prudent to address the nondiscrimination proposals related to
sexual orientation and gender identity in the 2022 NPRM to ensure
consistency across the policies and requirements applicable to entities
subject to both
[[Page 37670]]
those amendments and section 1557. 87 FR 27208. The clarifications
finalized in this section of the rule will apply on or after the
effective date of this final rule (60 days after publication).
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\397\ U.S. Dep't of Health & Hum. Servs. Ctrs. for Medicare &
Medicaid Servs., Patient Protection and Affordable Care Act; HHS
Notice of Benefit and Payment Parameters for 2023, 87 FR 584
(January 5, 2022).
\398\ U.S. Dep't of Health & Hum. Servs. Ctrs. for Medicare &
Medicaid Servs., Patient Protection and Affordable Care Act; HHS
Notice of Benefit and Payment Parameters for 2023, 87 FR 27208 (May
6, 2022).
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In finalizing amendments to the CMS regulations in this final rule,
the Department considered comments received in response to the 2022
NPRM, as well as comments received to similar proposals in the 2023
Payment Notice NPRM (collectively, the ``Proposed Rules''). The
Department is also responding to comments we received in response to
the Proposed Rules in this final rule. In section C.1. of this
preamble, the Department responds to comments applicable to 45 CFR
147.104(e), 155.120(c), 155.220(j), 156.125(b), 156.200(e), and
156.1230(b). Section C.2. provides a summary of regulatory changes for
45 CFR 155.120(c), 155.220(j), 156.200(e), and 156.1230(b); there were
no unique comments applicable to those sections. Comments that relate
specifically to 45 CFR 147.104 are addressed in section C.3. of this
preamble.
As stated in the 2022 NPRM, if any of the provisions at 45 CFR
147.104(e), 155.120(c), 155.220(j), 156.125(b), 156.200(e), and
156.1230(b) are held to be invalid or unenforceable by their terms, or
as applied to any person or circumstance, such provision shall be
considered severable from its respective section or such application
shall be considered severable from any valid or enforceable
applications of such provision (87 FR 47895). The determination that a
provision is invalid or unenforceable shall not affect either the
remainder of its section or any other sections, and the determination
that a provision is invalid or unenforceable as applied to any
particular person or circumstance shall not affect the application of
the provision to other persons not similarly situated or to other
dissimilar circumstances. In enforcing the nondiscrimination provisions
in the corresponding CMS regulations, the Department will comply with
laws protecting the exercise of conscience and religion, including, to
the extent applicable, section 1303 of the ACA, the Weldon, Church, and
Coats-Snowe amendments, the Religious Freedom Restoration Act (42
U.S.C. 2000bb through 2000bb-4) and all other applicable legal
requirements.
1. Comments and Responses to 45 CFR 147.104(e), 155.120(c), 155.220(j),
156.125(b), 156.200(e), and 156.1230(b)
The Department proposed to amend 45 CFR 147.104(e), 155.120(c),
155.220(j), 156.125(b), 156.200(e), and 156.1230(b) by removing the
term ``sex'' and revising the term to read ``sex (including sexual
orientation and gender identity).'' However, after considering all the
public comments submitted in response to the Proposed Rules, the
Department is finalizing a revision to the term ``sex'' and adding in
its place the phrase ``sex (including discrimination on the basis of
sex characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex
stereotypes).'' This revision is necessary to ensure consistency across
the policies and requirements applicable to entities subject to both
those amendments and section 1557.
Comment: The majority of commenters to the proposal in the 2023
Payment Notice NPRM expressed broad support for the proposal and agreed
that amending the CMS regulations is warranted in light of the well-
documented discrimination that LGBTQI+ individuals face in seeking
health care and insurance coverage.
Commenters supporting the proposal asserted that all Americans
deserve access to affordable, high-quality health care, and that
Federal policies and nondiscrimination protections must reinforce
equity of care for all patients regardless of socioeconomic and
sociodemographic characteristics and insurance coverage. Commenters
urged the Department to finalize the proposed nondiscrimination
protections in light of persisting trends of pervasive discrimination
in insurance coverage. Commenters said that it is well documented that
LGBTQI+ individuals continue to face discrimination in seeking health
care, and that the nondiscrimination protections will help address
barriers to health equity for LGBTQI+ individuals and aid providers in
providing effective care.
Many commenters supporting the proposal referred to copious bodies
of research, including research identified in the 2022 NPRM, that
demonstrate the many ways in which the LGBTQI+ community faces
discrimination when seeking health care, resulting in poorer health
outcomes. 87 FR 47833-47835 (2022). Commenters asserted that issuers
have contributed to this discrimination by employing transgender-
specific exclusions to deny coverage for medically necessary treatment
and that this was exacerbated by the removal of protections on the
basis of sexual orientation and gender identity in the 2020 Rule. Many
of these commenters also highlighted how individuals who identify as
part of the LGBTQI+ community disproportionately face health
disparities and are at higher risk for many conditions.
Response: We firmly believe that clarifying the scope of sex
discrimination can lead to improved health outcomes for LGBTQI+
individuals \399\ and that these protections are consistent with our
broader aim of improving health equity. Finalizing the amendments to
the nondiscrimination protections to explicitly prohibit discrimination
on the basis of sex characteristics, including intersex traits;
pregnancy or related conditions; sexual orientation; gender identity;
and sex stereotypes is warranted to help remedy health care
discrimination and to better address barriers to health equity for
LGBTQI+ individuals.\400\ The revisions to 45 CFR 147.104(e),
155.120(c), 155.220(j), 156.125(b), 156.200(e), and 156.1230(b) will
support the Department's objective of ensuring consistency against
employing discriminatory marketing practices and benefit designs.
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\399\ Brian W. Ward et al., U.S. Dep't of Health & Hum. 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.pdfhttps://www.cdc.gov/nchs/data/nhsr/nhsr077.pdf.
\400\ 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. Internal Med. 291-297 (2017), https://doi.org/10.1007/s11606-017-4209-5.
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Comment: Many of the commenters that supported the proposal in the
2023 Payment Notice NPRM suggested ways in which the Department could
further strengthen or clarify the breadth of the nondiscrimination
protections, such as by expressly prohibiting discrimination on the
basis of sex characteristics, including intersex traits.
Many commenters also recommended that the Department clarify that
gender identity discrimination includes discrimination based on gender
expression and transgender status. Such commenters stated that entities
often perpetuate discrimination against transgender people because of
their gender expression or belief that they are transgender rather than
their gender identity itself, which is often private information. These
commenters argued that the inclusion of ``gender identity'' alone in
nondiscrimination protections leaves room for confusion or evasion of
legal obligations.\401\ Commenters
[[Page 37671]]
emphasized that expressly incorporating transgender status into
Department regulations would provide additional clarity, and would
conform the regulation to contemporary protections against
discrimination.
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\401\ See U.S. Dep't of Health & Hum. Servs., FAQs About
Affordable Care Act Implementation (Part XXVI), 6, Q5 (May 11,
2015), https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/aca_implementation_faqs26.pdf. Section 2713 of the PHS Act
and its implementing regulations require non-grandfathered group
health plans and health insurance issuers offering non-grandfathered
group or individual health insurance coverage to provide coverage
for certain recommended preventive health services without imposing
any cost-sharing requirements. Under this requirement, the plan or
issuer must provide coverage, without cost sharing, for a
recommended preventive service that is medically appropriate for the
individual, as determined by the individual's attending provider,
regardless of the individual's sex assigned at birth, gender
identity, or recorded gender.
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Response: We agree with commenters that discrimination on the basis
of sexual orientation and gender identity may present itself as
discrimination on the basis of gender expression and transgender
status, which are inextricably linked with one's gender identity. We
believe that gender expression and transgender status are sufficiently
addressed by the inclusion of gender identity in the description of
discrimination based on sex that is being finalized.
Comment: Many commenters supported the proposal as consistent with
the overarching intent of the ACA to improve access to health coverage
and prohibit discrimination in health care, asserting that the removal
of protections on the basis of sexual orientation and gender identity
in the 2020 Rule frustrates this purpose by creating barriers to
comprehensive care. Many commenters affirmed that the Department has
broad authority to regulate in this area under various sections of the
ACA independent of section 1557. Specifically, commenters acknowledged
that section 1321(a) of the ACA \402\ gives the Department broad
rulemaking authority to regulate Exchanges and QHPs; section 1312(c)
\403\ gives the Department authority to establish procedures for States
to allow agents or brokers to enroll individuals and businesses in
QHPs; section 1302(b)(4) \404\ directs the Department, in defining EHB,
to ``take into account the health care needs of diverse segments of the
population, including women, children, persons with disabilities, and
other groups''; section 1311(c)(1)(A) \405\ directs the Department to
establish criteria for QHPs to ensure that they will ``not employ
marketing practices or benefit designs that have the effect of
discouraging the enrollment in such plan by individuals with
significant health needs''; and section 2792 of the PHS Act \406\
provides the Department with broad authority to promulgate regulations
that may be necessary or appropriate to carry out the provisions of
title XXVII of the PHS Act, including the guaranteed availability
provisions in section 2702,\407\ added to the PHS Act by the ACA.
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\402\ 42 U.S.C. 18041(a).
\403\ 42 U.S.C. 18032(c).
\404\ 42 U.S.C. 18022(b)(4),
\405\ 42 U.S.C. 13031(c)(1)(A).
\406\ 42 U.S.C. 300gg-92
\407\ 42 U.S.C. 300gg-1.
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Response: We agree with commenters that clarifying the scope of sex
discrimination aligns with the ACA's goals of improving access to
health insurance and removing unreasonable barriers to care. We
reiterate that we are relying on authority from sections 1311(c)(1)(A),
1312(e), and 1321(a)(1)(A), (B), and (D) of the ACA, as well as
sections 2702 and 2792 of the PHS Act, to support this change. 87 FR
584, 596.
Comment: Some commenters objected to the protections against
discrimination on the basis of gender identity, in particular, or
stated that the Proposed Rule arbitrarily requires coverage of
interventions for individuals diagnosed with gender dysphoria, but not
for individuals seeking such procedures for other clinically indicated
mental health conditions. Some commenters asserted the proposal is
arbitrary and capricious because it requires issuers to provide
coverage for a ``one-size-fits-all'' treatment to gender dysphoria that
is unsupported by evidence. Such commenters, believing that the
proposal requires coverage of gender-affirming care, stated that the
Department can adequately protect people from discrimination without
mandating this coverage.
Response: One of the primary goals of the proposals to clarify the
scope of sex discrimination is to address the pervasive health care
discrimination faced by LGBTQI+ patients.\408\ When medically necessary
treatments are categorically excluded when sought by transgender
enrollees for purposes of gender-affirming care, but the same such
treatments are covered for cisgender enrollees, such exclusions may
deny transgender individuals access to coverage based on their sex.
These types of exclusions, and other types of sex discrimination, can
have the effect of discouraging or preventing the enrollment of LGBTQI+
individuals in health insurance coverage.
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\408\ U.S. Dep't of Health & Hum. Servs., Ctrs. for Disease
Control & Prevention, Nat'l Ctr. for Health Statistics, Chapter 25:
Lesbian, Gay, Bisexual, and Transgender Health, Healthy People 2020
(2016), https://www.cdc.gov/nchs/data/hpdata2020/HP2020MCR-C25-LGBT.pdf; Hudaisa Hafeez et al., Health Care Disparities Among
Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review,
9 Cureus e1184 (2017), https://doi.org/10.7759/cureus.1184; 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 1802-1809 (2013), https://doi.org/10.2105/AJPH.2012.301110; Billy A. Caceres et al., A Systematic Review of
Cardiovascular Disease in Sexual Minorities, 107 a.m. J. Pub. Health
e13-e21 (2017), https://doi.org/10.2105/AJPH.2016.303630.
---------------------------------------------------------------------------
Issuers generally have discretion in designing their benefits
packages, and this rule does not require entities to cover any
particular procedure or treatment. We clarify that, in finalizing the
prohibition against discrimination on the basis of sex, the Department
is not mandating that health insurance issuers include coverage for any
particular item or service not already covered. However, to the extent
a covered entity provides coverage for a particular health service, the
covered entity must provide coverage for the health service to all
individuals in a neutral, nondiscriminatory manner consistent with this
rule.
Amending these sections to specify discrimination on the basis of
sex includes sex characteristics, including intersex traits; pregnancy
or related conditions; sexual orientation; gender identity; and sex
stereotypes will help better ensure that all individuals are treated
fairly in their access to health care. Without protection from such sex
discrimination, transgender individuals may face barriers or be denied
medically necessary services that are classified as covered under their
plan and made available to other enrolled individuals. Regulations at
45 CFR 147.104(e), 155.120(c), 155.220(j), 156.125(b), 156.200(e), and
156.1230(b) already prohibit discrimination on a variety of bases,
including 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.
Amending these sections to describe sex discrimination will better
clarify nondiscrimination protections for all individuals, while also
addressing existing disparities for LGBTQI+ individuals seeking health
care.
Comment: Many commenters that objected to the proposed
clarification suggested that coverage of gender-affirming care and any
corresponding treatments are unsupported by clinical evidence, harmful
to patients, and incongruent with the belief that gender is immutably
defined by one's biological sex. For example, many commenters asserted
that due to the lack of clinical evidence, CMS decided in 2016 not to
issue a National Coverage Determination
[[Page 37672]]
(NCD) \409\ for coverage of gender-affirming surgery for Medicare
beneficiaries with gender dysphoria. Many objecting commenters also
claimed that studies that reach different conclusions (for example, any
studies showing efficacy or safety of gender-affirming care) are
flawed.
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\409\ U.S. Dep't of Health & Hum. Servs., Ctrs. for Medicare &
Medicaid Servs., Decision Memo for Gender Dysphoria and Gender
Reassignment Surgery (CAG-00446N) (Aug. 30, 2016), https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=282.
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Response: We believe that commenters citing the 2016 Medicare NCD
decision are incorrectly interpreting the decision. In its final
Decision Memorandum on the issue, CMS notes that it declined to issue
an NCD specifically on gender-affirming surgery because the clinical
evidence is inconclusive, specifically as it relates to the Medicare
population (that is, generally individuals 65 or older). CMS clarifies
that the result of the decision is not a national coverage prohibition,
but rather a continuation of the current policy that coverage decisions
for gender-affirming surgery will continue to be made by local Medicare
Administrative Contractors (MACs) and Medicare Advantage (MA) plans on
a case-by-case basis based on whether gender-affirming surgery is
reasonable and necessary for the individual beneficiary after
considering the individual's specific circumstances.
Furthermore, the Medicare program did not analyze clinical evidence
for counseling or hormone therapy treatments for gender dysphoria and
was not making an NCD determination related to counseling, hormone
therapy treatments, or any other potential treatment for gender
dysphoria. Therefore, not only is the population for which the NCD
applies distinct, but so is the scope of the NCD decision itself.
Claims made by opposing commenters regarding assertions of patient
harm resulting from gender-affirming care, purported lack of evidence
demonstrating efficacy of such care, alleged differences between
``biological sex'' and gender, and hypothetical medical scenarios are
not germane to the proposed regulatory text acknowledging that sex
discrimination includes discrimination on the basis of sexual
orientation or gender identity. While claims about medical evidence and
specific treatments may be relevant in evaluating whether a particular
action constitutes unlawful discrimination, or whether a particular
item or service is medically necessary, such assertions do not speak to
the decision to clarify the scope of sex discrimination in the first
place. We also acknowledge that there is a robust consensus in the
medical community that gender-affirming care is safe, effective, and
medically necessary when clinically indicated for a particular
individual.
The amendments made concurrent with the 2020 final rule to the
nondiscrimination protections in 45 CFR 147.104(e), 155.120(c),
155.220(j), 156.125(b), 156.200(e), and 156.1230(b) were based on an
erroneous assertion that the plain statutory meaning of ``sex'' does
not encompass sexual orientation and gender identity, which is
unsupported by Bostock. In addition, the 2020 amendments were based on
the incorrect assertion that the denial of basic health care on the
basis of gender-identity is not a widespread problem in the United
States.
Comment: One commenter asserted that the proposed change to the
description of sex discrimination is arbitrary and capricious because
the Department did not compute the costs of the impact of the rule
against the purported benefits of the proposal.
Response: As we explained in the 2022 NPRM and based on our
experience with States selecting a new EHB-benchmark plan pursuant to
45 CFR 156.111,\410\ CMS believes there will be minimal costs incurred
based on amending these sections to clarify sex discrimination. Because
these sections previously prohibited discrimination on the basis of
sexual orientation and gender identity, many entities already comply
with the prohibition on discrimination, as amended under this final
rule. 87 FR 47898. We do not anticipate amending these sections to
describe sex discrimination would impose substantial administrative
costs on any regulated entities that did not subsequently revise
nondiscrimination policies based on the 2020 Rule.\411\ On balance, we
believe any costs are justified in light of the potentially significant
benefits provided by protecting individuals from discrimination based
on sex characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes.
We refer readers to our cost benefit analysis in the Regulatory Impact
Analysis of this final rule for additional discussion on the minimal
cost impacts to plans and issuers to include nondiscrimination
protections. 87 FR 47898.
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\410\ See, e.g., U.S. Dep't of Health & Hum. Servs., Ctrs. for
Medicare & Medicaid Servs., Information on Essential Health Benefits
(EHB) Benchmark Plans Colorado 2023 EHB- Benchmark Plan Actuarial
Report, https://www.cms.gov/marketplace/resources/data/essential-health-benefits. Suite of Gender-affirming care benefits to treat
gender dysphoria resulted cost estimate was 0.04 percent of the
total allowed claims assuming utilization would be for adults.
\411\ State of Cal., Dep't of Ins., Economic Impact Assessment
Gender Nondiscrimination in Health Insurance, (2012), http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf; 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; Jody L.
Herman, The Williams Inst., UCLA Sch. of Law, Costs and Benefits of
Providing Transition-Related Health Care Coverage in Employee Health
Benefits Plans: Findings from a Survey of Employers, p. 2, (Sept.
2013), http://williamsinstitute.law.ucla.edu/wp-content/uploads/Herman-Cost-Benefit-of-Trans-Health-Benefits-Sept-2013.pdf; 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. Gen. Internal Med. 394 (2015),
https://pubmed.ncbi.nlm.nih.gov/26481647/.
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Comment: Some commenters objected to a perceived lack of clarity in
the Proposed Rules. Such commenters noted that the Proposed Rules did
not appropriately discuss the breadth of which markets would be covered
by this proposal, questioning whether it would apply to large group
plans, fully insured group health plans sponsored by employers, health
insurance issuers and third party administrators of self-insured plans.
Response: The amendments we are finalizing to the nondiscrimination
regulations at 45 CFR 147.104(e) apply to health insurance issuers
offering non-grandfathered group or individual health insurance
coverage, and their officials, employees, agents, and representatives.
The nondiscrimination amendments we are finalizing at 45 CFR 155.120(c)
apply to States and Exchanges carrying out Exchange requirements. The
nondiscrimination amendments we are finalizing at 45 CFR 155.220(j)
apply to agents, brokers, or web-brokers that assist with or facilitate
enrollment of qualified individuals, qualified employers, or qualified
employees, in coverage in a manner that constitutes enrollment through
an FFE, or assists individuals in applying for advance payments of the
premium tax credit and cost-sharing reductions for QHPs sold through an
FFE. The nondiscrimination amendments we are finalizing at 45 CFR
156.200(e) apply to QHPs in the individual and small-group markets.
Section 156.125(b) requires issuers providing EHB to comply with the
requirements of 45 CFR 156.200(e), thereby extending the application to
non-grandfathered health insurance coverage in the individual and small
group markets that provide EHBs.
[[Page 37673]]
Lastly, the nondiscrimination protections we are finalizing at 45 CFR
156.1230(b) apply to issuers using direct enrollment on an FFE.
Comment: Some commenters noted concerns about how the
nondiscrimination protections would apply to health care providers.
Response: The amendments we are finalizing at 45 CFR 147.104(e),
155.120(c), 155.220(j), 156.125(b), 156.200(e), and 156.1230(b) do not
apply to health care providers.
Comment: One commenter asked the Department to provide clarity on
the interaction between the section 1557 requirement and the 2023
Notice of Benefit and Payment Parameters final rule regarding non-
discriminatory benefit design and EHB.
Response: While the requirements of section 1557 and the
requirements imposed on EHB are separate requirements, we are
finalizing regulatory language in this rule to make compliance easier
for entities that are subject to both standards. As we stated in the
2023 Notice of Benefit and Payment Parameters final rule, CMS continues
to make refinements to our EHB nondiscrimination policy and will
address non-discriminatory benefit design as it relates to EHB in
future rulemaking.
Comment: Commenters objecting to a more detailed understanding of
sex discrimination raised several legal concerns. Commenters stated
that the Department's reliance on Bostock v. Clayton County, 590 U.S.
644 (2020), is inappropriate, misinterprets Bostock, and misapplies the
case to section 1557. One commenter asserted that the rule is arbitrary
and capricious because it inappropriately applies the title VII
framework to health care. Other commenters stated that the proposal is
based on a faulty interpretation of title IX. Commenters also asserted
that although reverting the nondiscrimination sections to pre-2020
language would allow LGBTQI+ individuals to receive ``medically
necessary'' care, the 2020 rule enforces the plain text enacted by the
ACA, which prohibited the discrimination on the basis of sex only.
Other commenters cautioned that absent clear congressional
authorization, the Department is not justified in promoting the view
that sex or gender can be different than the sex assigned to an
individual at birth. Other commenters asserted that the rule is
arbitrary and capricious because it ignores that a person's sex is
determined by biology and does not sufficiently specify what it means
by ``sex'' and how it relates to gender dysphoria treatments.
Response: We disagree that the proposal to include
nondiscrimination protections is arbitrary and capricious. We are not
relying on or applying the title VII framework to the nondiscrimination
protections we are finalizing at 45 CFR 147.104(e), 155.120(c),
155.220(j), 156.125(b), 156.200(e), and 156.1230(b), nor are we relying
on other Federal civil rights laws for statutory authority. As stated
in the Proposed Rule, 87 FR 596, we are relying on authority from
sections 1311(c)(1)(A), 1312(e), and 1321(a)(1)(A), (B), and (D) of the
ACA to support the amendments at 45 CFR 155.120, 155.220, 156.200, and
156.1230. We also rely on authority from sections 2702 and 2792 of the
PHS Act to support the amendments to 45 CFR 147.104 and 156.125.
Section 2792 of the PHS Act provides the HHS Secretary with broad
rulemaking authority to issue regulations as may be necessary or
appropriate to carry out the provisions of title XXVII of the PHS Act,
including the guaranteed availability provision in section 2702 of the
PHS Act, implemented at 45 CFR 147.104, and the EHB requirements in
section 2707(a) of the PHS Act, implemented at 45 CFR 147.150 and
156.125. 87 FR 584, 596. We made these proposals and are finalizing
these provisions due in large part to the pervasive health and health
care disparities faced by people who identify as part of the LGBTQI+
community.\412\
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\412\ U.S. Dep't of Health & Hum. Servs., Ctrs. for Disease
Control & Prevention, Nat'l Ctr. for Health Statistics, Chapter 25:
Lesbian, Gay, Bisexual, and Transgender Health, Healthy People 2020
(2016), https://www.cdc.gov/nchs/data/hpdata2020/HP2020MCR-C25-LGBT.pdf; Hudaisa Hafeez et al., Health Care Disparities Among
Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review,
9 Cureus e1184 (2017), https://doi.org/10.7759/cureus.1184; 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 1802-1809 (2013), https://doi.org/10.2105/AJPH.2012.301110; Billy A. Caceres et al., A Systematic Review of
Cardiovascular Disease in Sexual Minorities, 107 a.m. J. Pub. Health
e13-e21 (2017), https://doi.org/10.2105/AJPH.2016.303630.
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The aim of this final rule is to address the reality of many
consumers in the health care sector and how discrimination on the basis
of sex by entities regulated under 45 CFR 147.104(e), 155.120(c),
155.220(j), 156.125(b), 156.200(e), and 156.1230(b) impairs the ability
of consumers to access or pay for quality care. We believe these
changes are necessary to address the role of discrimination in
perpetuating the pervasive health and health care disparities faced by
people who identify as part of the LGBTQI+ community.
We also disagree with commenters contesting that these
nondiscrimination proposals inappropriately align with Bostock. In
Bostock, the Supreme Court held that discrimination on the basis of sex
under title VII of the Civil Rights Act of 1964 includes discrimination
on the basis of sexual orientation and gender identity. Under Bostock's
reasoning, laws that prohibit sex discrimination also prohibit
discrimination on the basis of gender identity and sexual
orientation.\413\
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\413\ See, e.g., Grimm v. Gloucester Cnty. Sch. Bd., 972 F.3d
586, 616 (4th Cir. 2020), cert. denied, 141 S. Ct. 2878 (2021)
(``Although Bostock interprets Title VII of the Civil Rights Act of
1964, 42 U.S.C. 2000e-2(a)(1), it guides our evaluation of claims
under Title IX''); E.O. 13988, 86 FR 7023 (2021).
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Furthermore, the inclusion of ``sex stereotypes'' is consistent
with the Supreme Court's holding in Price Waterhouse v. Hopkins, 490
U.S. 228, 250-51 (1989). The inclusion of ``pregnancy or related
conditions'' is consistent with the Department's longstanding
interpretation of sex discrimination under Title IX.\414\ As noted
earlier in this preamble, the Department is finalizing these amendments
to ensure consistency across the policies and requirements applicable
to entities subject to health insurance market and Exchange
requirements and those subject to section 1557. Amending CMS
nondiscrimination protections to better specify the meaning of sex
discrimination is imperative to advancing health equity and ensuring
individuals are able to receive health care that is free from
discrimination as envisioned under the ACA.
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\414\ See 45 CFR 86.21(c)(2) and (3); 86.40(b)(1), (4), and (5);
86.51(b)(6); 86.57(b) through (d) (Title IX regulation); see also
Conley v. Northwest Fla. State Coll., 145 F. Supp. 3d 1073 (N.D.
Fla. 2015).
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Comment: Many commenters to the 2023 Payment Notice NPRM expressed
concerns that the proposal infringed on the First Amendment and would
lead to violations of the religious conscience of providers, issuers,
brokers, agents, and religiously affiliated hospitals. Some of these
commenters objected to the inclusion of sexual orientation or gender
identity within nondiscrimination protections altogether. Other
commenters asserted that it is unclear how CMS would implement RFRA
protections in the context of the nondiscrimination protections, and
that this lack of clarity would increase the chance of litigation. A
few commenters asked for the final rule to include an exemption for any
stakeholders with religious objections (including issuers,
[[Page 37674]]
plan sponsors, or individual purchasers) or to clarify whether there
will be a process for such stakeholders to claim an exemption under
RFRA outside of litigation. One commenter requested a process under
which issuers or the insured can receive an up-front exemption when
they have a religious or conscience-based objection to paying for plans
that cover benefits to which they object as being experimental and
harmful.
Other commenters believed that the proposal takes the right
approach in relation to moral and religious objections.
Response: These regulations are neutral, generally applicable, and
do not violate the Free Exercise Clause of the First Amendment. These
regulations do not target religiously motivated conduct, but rather,
are intended to prohibit sex discrimination generally in order to
improve health outcomes and fulfill the statutory command of the ACA to
prohibit discrimination and remove unreasonable barriers to care.
Certain protections already exist in Federal law with respect to
religious or moral beliefs, particularly regarding the provision of
certain health-related services. For example, when enforcing its
nondiscrimination regulations, HHS will comply with laws protecting the
exercise of conscience and religion, including RFRA and all other
applicable legal requirements. Nothing in the nondiscrimination
protections at 45 CFR 147.104(e), 155.120(c), 155.220(j), 156.125(b),
156.200(e), and 156.1230(b) displaces those protections, and an
application of this rule will not be required if it would violate
Federal religious freedom and conscience laws.
Although some commenters urged CMS to incorporate a categorical
religious exemption into this final rule, a blanket religious exemption
is not supported by the underlying statutes. We will apply the
protections in existing laws in resolving any conflicts between
religious beliefs and these nondiscrimination protections. An entity
that believes that compliance with any of these provisions would
violate their rights under RFRA or the Free Exercise Clause of the
First Amendment should contact CMS, which is responsible for evaluating
RFRA-based requests for requirements in the programs it operates or
oversees.\415\ An entity that believes that compliance with any
provision of this rule would violate their rights under the religious
freedom and conscience laws enforced by HHS's Office for Civil Rights
should file a complaint with OCR.
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\415\ U.S. Dep't of Health and Hum. Servs., Off. of the Sec'y,
Delegation of Authority, 86 FR 67067 (Nov. 24, 2021).
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As with any HHS program, if an entity alleges that HHS's actions
have substantially burdened its religious exercise, the Department will
apply the test set out by RFRA.\416\ The RFRA analysis evaluates
whether the actions of the Federal Government have substantially
burdened an entity's exercise of religion; if so, the question becomes
whether the action furthers a compelling interest and is the least
restrictive means to further that interest. RFRA provides that when
application of a Federal Government rule or other law would
substantially burden a person's exercise of religion, the government
must afford that person an exemption to the rule unless it can
demonstrate that applying the burden to that person furthers a
compelling governmental interest and is the least restrictive means of
doing so.\417\ Accordingly, under RFRA, we would assess whether a
particular application of these rules substantially burdened a
stakeholder's exercise of religion and, if so, whether the government
has a compelling interest in denying the stakeholder's exemption
assurance request and whether there are less restrictive alternatives
available.\418\ The government's compelling interest in prohibiting
discrimination on the basis of sex is to improve health outcomes,
including for the LGBTQI+ community, and fulfill the statutory command
of the ACA to prohibit discrimination. Whether this prohibition imposes
a substantial burden on an entity's exercise of religion and whether it
is the least restrictive means of advancing the government's interest
will depend on specific facts and circumstances.
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\416\ See 86 FR 67067 (Nov. 24, 2021) (delegation of authority
under which all HHS components are to ensure full compliance with
RFRA and other constitutional requirements).
\417\ 42 U.S.C. 2000bb-1(b).
\418\ Fulton v. City of Phila., 593 U.S. (2021) (``The question,
then, is not whether the City [of Philadelphia] has a compelling
interest in enforcing its non-discrimination policies generally, but
whether it has such an interest in denying an exception to [Catholic
Social Services].'').
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The amendments we are finalizing at 45 CFR 147.104(e), 155.120(c),
155.220(j), 156.125(b), 156.200(e), and 156.1230(b) prohibit
discrimination on the basis of sex in the conduct of health insurance
issuers and their officials, employees, agents, and representatives;
States and the Exchanges; agents, brokers, or web-brokers that assist
with or facilitate enrollment of qualified individuals, qualified
employers, or qualified employees; issuers subject to EHB requirements;
and QHP issuers. Lastly, we again reiterate that the amendments we are
finalizing at 45 CFR 147.104(e), 155.120(c), 155.220(j), 156.125(b),
156.200(e), and 156.1230(b) do not require regulated entities to cover
any particular service not already covered.
2. Health Insurance Exchanges
a. Non-Interference With Federal Law and Nondiscrimination Standards
(45 CFR 155.120)
In 45 CFR 155.120 we proposed to amend paragraph (c)(1)(ii) by
removing the term ``sex'' and adding in its place the phrase ``sex
(including sexual orientation and gender identity).'' We did not
receive comments unique to this section.
Summary of Regulatory Changes
We amend 45 CFR 155.120 in paragraph (c)(1)(ii) by removing the
term ``sex'' and adding in its place the phrase ``sex (including
discrimination on the basis of sex characteristics, including intersex
traits; pregnancy or related conditions; sexual orientation; gender
identity; and sex stereotypes).''
b. Federally-Facilitated Exchange Standards of Conduct (45 CFR 155.220)
In 45 CFR 155.220 we proposed to amend paragraph (j)(2)(i) by
removing the term ``sex'' and adding in its place the phrase ``sex
(including sexual orientation and gender identity).'' We did not
receive comments unique to this section.
Summary of Regulatory Changes
We amend 45 CFR 155.220 in paragraph (j)(2)(i) by removing the term
``sex'' and adding in its place the phrase ``sex (including
discrimination on the basis of sex characteristics, including intersex
traits; pregnancy or related conditions; sexual orientation; gender
identity; and sex stereotypes).''
c. Essential Health Benefits Package: Prohibition on Discrimination (45
CFR 156.125)
In 45 CFR 156.200 we proposed to 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).'' Section
156.125(b) would accordingly require issuers providing EHB to comply
with such nondiscrimination requirements as it requires that an issuer
providing EHB must comply with the requirements of Sec. 156.200(e). We
did not receive comments unique to this section.
[[Page 37675]]
Summary of Regulatory Changes
Elsewhere in this rule, we amend 45 CFR 156.200 in paragraph (e) by
removing the term ``sex'' and adding in its place the phrase ``sex
(including discrimination on the basis of sex characteristics,
including intersex traits; pregnancy or related conditions; sexual
orientation; gender identity; and sex stereotypes).'' Paragraph (b) of
45 CFR 156.125 accordingly requires issuers providing EHB to comply
with such nondiscrimination requirements as it states that an issuer
providing EHB must comply with the requirements of Sec. 156.200(e).
d. QHP Issuer Participation Standards (45 CFR 156.200)
In 45 CFR 156.200 we proposed to amend paragraph (e) by removing
the term ``sex'' and adding in its place the phrase ``sex (including
sexual orientation and gender identity).'' We did not receive comments
unique to this section.
Summary of Regulatory Changes
We amend 45 CFR 156.200 in paragraph (e) by removing the term
``sex'' and adding in its place the phrase ``sex (including
discrimination on the basis of sex characteristics, including intersex
traits; pregnancy or related conditions; sexual orientation; gender
identity; and sex stereotypes).''
e. Direct Enrollment With the QHP Issuer in a Manner Considered To Be
Through the Exchange (45 CFR 156.1230)
In 45 CFR 156.1230 we proposed to 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).'' We did not
receive comments unique to this section.
Summary of Regulatory Changes
We amend 45 CFR 156.1230 in paragraph (b)(2) by removing the term
``sex'' and adding in its place the phrase ``sex (including
discrimination on the basis of sex characteristics, including intersex
traits; pregnancy or related conditions; sexual orientation; gender
identity; and sex stereotypes).''
3. Prohibition of Discrimination--Group and Individual Health Insurance
Markets Guaranteed Availability of Coverage (45 CFR 147.104)
In 45 CFR 147.104 we proposed to amend paragraph (e) by revising
``sex'' to ``sex (including sexual orientation and gender identity).''
The comments and our responses regarding this proposal are set
forth below.
Comment: Some commenters requested that CMS clarify that States,
including State Attorneys General, may enforce section 1557 to the
fullest extent granted by law. That request was in response to CMS'
explanation in the Proposed Rule that it was not relying on section
1557 as authority to amend 45 CFR 147.104 because states would not have
authority to enforce section 1557 and CMS is of the view that partial
reliance on section 1557 could unnecessarily complicate enforcement
efforts. 87 FR 47898.
Response: In the Proposed Rule, CMS explained that one of the
primary reasons CMS did not propose to rely on section 1557 authority
to amend 45 CFR 147.104 was the manner in which Sec. 147.104 is
enforced. As discussed in the Proposed Rule, under PHS Act section
2723, States have primary enforcement authority over issuers with
respect to regulations that implement title XXVII of the PHS Act, which
includes Sec. 147.104. CMS has a responsibility to enforce such
regulations if CMS determines that a State is not substantially
enforcing or the State notifies CMS that it has not enacted legislation
to enforce or is not otherwise enforcing such regulations; otherwise,
the State retains primary enforcement authority. Because section 1557
is not codified in title XXVII of the PHS Act, PHS Act section 2723
does not provide States with the authority to enforce section 1557.
Therefore, CMS continues to be of the view that partial reliance on
section 1557 authority could unnecessarily complicate enforcement
efforts of Sec. 147.104.
For this reason and because Sec. 147.104 applies to issuers that
may not receive Federal financial assistance such that they would be
subject to section 1557, CMS relies on its authorities under sections
2702 and 2792 of the PHS Act when amending Sec. 147.104.
Notwithstanding the foregoing, the Department clarifies that although
States do not enforce the administrative procedures specified in the
section 1557 regulation itself, States may utilize their independent
enforcement authorities to pursue violations of law, including
applicable Federal laws, by entities within their jurisdictions.
Summary of Regulatory Changes
We amend 45 CFR 147.104 in paragraph (e) by removing the term
``sex'' and adding in its place the phrase ``sex (including
discrimination on the basis of sex characteristics, including intersex
traits; pregnancy or related conditions; sexual orientation; gender
identity; and sex stereotypes).''
V. Executive Order 12866 and Related Executive Orders on Regulatory
Review
A. Regulatory Impact Analysis
We have examined the impacts of the final rule under E.O. 12866,
E.O. 14094, E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-
612), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and
E.O. 13132 on Federalism. 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). Section 3(f) of E.O. 12866 (as amended by E.O. 14094) defines
a ``significant regulatory action'' as any regulatory action that is
likely to result in a rule that may: (1) have an annual effect on the
economy of $200 million or more (adjusted every 3 years by the
Administrator of the Office of Information and Regulatory Affairs
(OIRA) for changes in gross domestic product); or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, territorial, or Tribal governments or communities; (2) create a
serious inconsistency or otherwise interfere with an action taken or
planned by another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise legal or policy issues
for which centralized review would meaningfully further the President's
priorities or the principles set forth in this Executive order, as
specifically authorized in a timely manner by the Administrator of OIRA
in each case. This final rule is a significant regulatory action, under
sec. 3(f)(1) of E.O. 12866 (as amended by E.O. 14094).
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 final 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 are certifying that the final 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
[[Page 37676]]
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 1 year.'' The current threshold after adjustment
for inflation is $177 million, using the most current (2022) Implicit
Price Deflator for the Gross Domestic Product. This final rule is not
subject to the Unfunded Mandates Reform Act because it falls under an
exception for regulations that establish or enforce any statutory
rights that prohibit discrimination on the basis of race, color,
religion, sex, national origin, age, or disability.\419\
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\419\ 2 U.S.C. 1503(2).
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E.O. 13132 on Federalism establishes certain requirements that an
agency must meet when it promulgates a Proposed Rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has federalism
implications. In considering the principles in and requirements of E.O.
13132, the Department has determined that the final rule would not
significantly affect the rights, roles, and responsibilities of the
States.
The Congressional Review Act (CRA) defines a ``major rule'' as any
rule that the Administrator of OIRA of the Office of Management and
Budget finds has resulted in or is likely to result in: (A) ``an annual
effect on the economy of $100,000,000 or more''; (B) ``a major increase
in costs or prices for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions''; or (C)
``significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic and
export markets.'' 5 U.S.C. 804(2). Based on the analysis of this final
rule under E.O. 12866, this rule is expected qualify under 5 U.S.C.
804(2)(A). The Department will comply with the CRA's requirements to
inform Congress.
The Background and Reasons for the final rulemaking sections at the
beginning of this preamble contains a summary of this final rule and
describes the reasons it is needed.
1. Public Comments
Comment: OCR received some comments discussing the cost of notices
and taglines \420\ in addition to requests that OCR work with the
health care industry to develop future regulations. One commenter
explained how the cost of including taglines averages up to $8.91 per
month per covered entity and upwards of $2 million a year for the
health insurance industry. Another health insurer commenter stated that
they have spent over $16 million on notices and taglines since 2016 and
estimated that they have spent over $3 million in 2022 alone. However,
neither commenter provided data explaining the source or more detail on
the cost estimates. Another commenter noted that the Proposed Rule does
not adequately answer complaints received in prior 1557 rulemakings on
the frequency and volume of materials related to the notice and tagline
sections of the rule but did not provide any data with their comment.
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\420\ Commenters referred to ``taglines,'' which were required
in the 2016 Rule at former Sec. 92.8(d). This final rule does not
require ``taglines'' but instead requires a notice of availability
of language assistance services and auxiliary aids and services
(referred to as ``Notice of Availability'') at Sec. 92.11.
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Response: Based on costs estimated in this analysis, OCR derives a
monthly cost of notices ranging from $21.28 to $26.60 per entity
depending on the prevalence of electronic delivery. These cost
estimates include the total notices of nondiscrimination and notices of
availability of language assistance services and auxiliary aids and
services (``Notices of Availability''); OCR therefore finds the
commenter's estimate of $8.91 per month for Notices of Availability as
plausible and consistent with the estimates in section 2 of the
Regulatory Impact Analysis. OCR also notes that the cost estimates that
are given are averages, and it is expected that there will be some
entities that would have costs that are well above or below average.
Furthermore, it is expected that large entities would have higher than
average costs due to the increased number of notices they would send to
individuals.
Comment: A few commenters expressed general concerns on the
potential for an increase in premiums and costs within the health care
industry. Commenters suggested the final rule would create a moral
hazard for individuals or made general statements without data that
increasing coverage of goods and services would increase costs and
resulting premiums. Other commenters focused on the harm to small
business the rule would cause from raising the insurance costs for low-
income individuals that small businesses employ. Commenters argued this
would lead to layoffs of said employees and limit what services would
be available.
Response: As discussed in section 2 of the RIA, OCR expects that
there is a possibility of increased premiums and costs due to the rule,
but the possible increase is expected to be a small percentage of the
current costs due to the low utilization of gender-affirming care and
supply of specialists capable of offering said services. OCR does not
expect the final rule to have a significant economic impact on small
entities based on the analysis in the Regulatory Flexibility Act (RFA).
Comment: A couple of commenters were concerned that the rule would
make it more difficult for small entities to compete and remain
compliant, which would give a competitive advantage to larger entities
in the industry and lead to more consolidation of supplier and provider
markets.
Response: OCR appreciates the concerns raised by these commenters;
however, as discussed in the RFA, OCR does not expect a significant
impact of costs on a substantial number of small entities.
Comment: A few commenters claimed that the final rule would lead to
lower innovation within the health care industry due to an increased
need to spend funds fighting discrimination instead of medical
research.
Response: As discussed in section 2 of the RIA, OCR estimates that
additional costs from the inclusion of nondiscrimination requirements
will be a small percentage of the total cost due to the limited number
of individuals that would seek gender-affirming care, thereby limiting
any potential decrease in available funds for medical research.
Comment: A few commenters expressed concern that the final rule
would limit rural health care because it would make it more difficult
for rural entities to stay compliant and would worsen their financial
positions, potentially resulting in closures.
Response: As discussed in section 2 of the RIA, OCR estimates that
the costs associated with the final rule would be a small percentage
increase in overall costs. Furthermore, OCR reviewed relevant
literature and found no studies which suggested that rural hospitals
would be particularly impacted by expanded health care services.
Finally, as discussed in the small entity analysis section of this RIA,
OCR does not estimate a significant economic impact on a substantial
number of small entities.
Comment: Several commenters expressed concern that the final rule
would lead to fewer health care professionals in the industry for a
[[Page 37677]]
variety of reasons. Some of the commenters stated that the final rule
would lead to health care professionals leaving the industry from the
lack of conscience or religious exemptions. A couple of commenters
stated that future health care professionals would not enter the
industry in the future as the final rule would require them to violate
the Hippocratic Oath or their religious beliefs.
Response: As discussed in section 2 of the RIA and preamble of the
rule, the final rule includes a variety of protections for religious
freedom and conscience rights, including a process whereby entities may
rely on these protections and seek assurance of them from HHS. See
Sec. 92.302.
Comment: Several commenters noted that portions of the data that
were used in the RIA, such as the number of covered entities and number
of small entities, are outdated and need to be updated for an accurate
cost estimate to be made.
Response: OCR agrees with commenters that data sources could be
updated from the Proposed Rule. In this final rule RIA, the data for
the number of covered entities, number of entities with more than 15
employees, the number of small entities, and hourly wages have been
updated to the most recent data available.
Comment: A few commenters expressed concern that the final rule
would cause irreparable harm to individuals who regret transitions.
Response: Commenters do not provide supporting evidence or data on
the frequency or cost of potential irreparable harm. OCR disagrees with
the commenters and did not find studies providing evidence or data on
the frequency or cost of what the commenters characterize as
irreparable harm, and therefore makes no changes to the final rule.
Comment: One commenter expressed concern that long-term costs
associated with gender-affirming care are not accounted for within the
RIA and that the studies used may not be accurate. Due to this, the
commenter stated that the supplementary information provided is at best
speculative.
Response: The main source for costs related to gender-affirming
care come from a peer reviewed article in the New England Journal of
Medicine, a well-respected medical journal. The cost associated with
gender-affirming care is based on actual cost data from the Defense
Manpower Data Center, which is part of the Department of Defense (DOD).
As noted, the final rule does not mandate the provision of or coverage
of gender-affirming care, or any particular health service. However, to
the extent a covered entity provides coverage for a particular health
service, the covered entity must provide the health service to all
individuals in a neutral, nondiscriminatory manner consistent with this
rule.
Comment: One commenter stated that the costs of algorithmic
discrimination have been quantified and asked OCR to include examples
of the costs of such discrimination.
Response: OCR includes a specific provision on algorithmic
discrimination in the final rule and qualitatively discusses the
potential costs to individuals from discriminatory application of
algorithms and other decision support tools in the benefits section.
2. Summary of Costs and Benefits
This analysis quantifies several categories of costs to covered
entities and to the Department under the final 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.
We quantify costs associated with provisions of the final rule related
to documenting training activities performed under the final rule. We
also quantify incremental costs associated with coverage for gender-
affirming care (which, as noted above, is not mandated by the rule).
Our analysis also addresses uncertainty in costs associated with
notices and gender-affirming care, which is discussed in greater detail
in the notices section of subsection B of section 2 of the RIA. We
separately report a full range of cost estimates of about $523 million
to $1,302.3 million using a 7 percent discount rate, and a full range
of cost estimates of about $511.4 million to $1,290.7 million using a 3
percent discount rate. All cost estimates are in 2022 dollars. We
conclude that the final rule would result in annualized costs over a 5-
year time horizon of $646.5 million or $637.1 million, corresponding to
a 7 percent or a 3 percent discount rate respectively.
In addition to these quantified cost estimates, the main analysis
includes a discussion of costs that we do not quantify, and a
discussion of the potential benefits under the rule that we similarly
do not quantify. In addition to the impacts that we quantify, this
final rule could also result in increases in premiums, which would
result in increases in Exchange user fees and Federal expenditures for
advance payments of the premium tax credit. These increases would be
minimal due to the low utilization of gender affirming care and the
availability of the services.
Table 1--Annualized Costs of the Final Rule
[$ millions/year (percent)]
----------------------------------------------------------------------------------------------------------------
Discount rate
Primary estimate Low estimate High estimate Year dollars (percent) Period covered
----------------------------------------------------------------------------------------------------------------
$646.5 $523 $1,302.3 2022 7 2024-2028
$637.1 511.1 1,290.7 2022 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.\421\ On May 18, 2016, the Department published a
final rule to implement section 1557 under the statute5 U.S.C. 301. 81
FR 31375. On June 19, 2020, the Department published a final rule that
revised the Department's approach to implementing section 1557. 85 FR
37160. As described in greater detail in the Background section of this
preamble, neither final rule was fully implemented as published, and
certain provisions of the 2020 Rule remain the subject of ongoing
litigation.
---------------------------------------------------------------------------
\421\ 42 U.S.C. 18116.
---------------------------------------------------------------------------
[[Page 37678]]
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 2016 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 Rule were incurred.\422\ 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.'' 85 FR
37224. 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.'' 85 FR 37224.
---------------------------------------------------------------------------
\422\ E.g., 85 FR 37235 (``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 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 $108.8 million (reported in 2022 dollars), which we adopt as the
costs under both the baseline and final 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.
The final rule analysis updates baseline conditions on the number
of covered entities. The 2016 Rule, 2020 Rule, and 2022 NPRM all used
275,002 covered entities, and 41,250 covered entities that have 15 or
more employees. This final rule updates the covered entities to 266,297
and the number of covered entities with 15 or more employees to 63,950.
Table 2 presents the updated data on covered entities. To update this
data, we identified the source of the original data being the 2012
Statistics of U.S. Businesses (SUSB) Annual Data Tables by
Establishment Industry and found the 2020 version of the same dataset.
Using the same NAICS codes from the Proposed Rule we identify the
number of entities under these NAICS codes in addition to the number of
firms with 15 or more employees.
Table 2--Covered Entities
----------------------------------------------------------------------------------------------------------------
Firms with 15 or
NAICS code Business type Firm count 2020 more employees
----------------------------------------------------------------------------------------------------------------
62142...................................... Outpatient mental health and 7,649 2,911
substance abuse centers.
621491..................................... HMO medical centers.......... 84 21
621492..................................... Kidney dialysis centers...... 449 216
621493..................................... Freestanding ambulatory 4,554 2,204
surgical and emergency
centers.
621498..................................... All other outpatient care 6,307 2,766
centers.
6215....................................... Medical and diagnostic 7,200 1,892
laboratories.
6216....................................... Home health care services.... 25,718 10,901
6219....................................... All other ambulatory health 7,091 2,589
care services.
62321...................................... Residential intellectual and 6,674 3,628
developmental disability
facilities.
6221....................................... General medical and surgical 2,445 2,344
hospitals.
6222....................................... Psychiatric and substance 434 414
abuse hospitals.
6223....................................... Specialty (except psychiatric 301 280
and substance abuse)
hospitals.
6231....................................... Nursing care facilities 9,824 7,513
(skilled nursing facilities).
45611...................................... Pharmacies and drug stores... 19,346 3,436
6211....................................... Offices of physicians........ 167,294 22,494
524114..................................... Insurance Issuers............ 869 341
Navigator grantees........... 58 .................
--------------------------------------------------------------------
Total Entities............... 266,297 63,950
----------------------------------------------------------------------------------------------------------------
In the next section, we discuss the incremental costs of the final
rule, which exclude ongoing costs attributable to prior rulemaking.
b. Costs of the Final Rule
This analysis anticipates that the final rule would result in one-
time costs to covered entities to process assurance of exemption
requests and revise policies and procedures. The final rule would
result in costs associated with a revised approach to notices,
including the Notice of Nondiscrimination and Notice of Availability,
costs to review new decision support tool requirements, and costs to
training employees. The final rule would also result in costs
associated with provisions related to documenting training activities
performed under the final rule.
The final rule might result in additional costs associated with
coverage for gender-affirming care. We discuss the potential costs
associated with gender-affirming care coverage and the potential that
some or all of these costs would be offset by reductions in spending on
other types of care. We
[[Page 37679]]
reiterate that the final rule does not mandate the provision of or
coverage of gender-affirming care, or any particular health service.
However, to the extent a covered entity provides coverage for a
particular health service, the covered entity must provide the health
service to all individuals in a neutral, nondiscriminatory manner
consistent with this rule.
The analysis also discusses other potential costs of the final rule
that we do not quantify.
Training
The Department anticipates that some covered entities would incur
costs to train or retrain employees under the final rule. To calculate
the costs related to training, we followed an approach common to both
the 2016 and 2020 RIAs. Both analyses estimate that covered entities
would train their employees on the requirements. This final rule uses
the updated estimate of covered entities (266,297) as the basis for
calculating the total costs. The 2020 RIA adjusted the number of
covered entities downward by 50 percent, 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 percent 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 percent of total employees at
covered entities would receive training, while the 2020 RIA assumed
that 25 percent of employees would receive training. Both RIAs assumed
the typical training would last one (1) hour. For this analysis, we
assume that 75 percent 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 final 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 final rule, we have collected the
most recent available data on the number of employees that would likely
undergo training under the final 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 2022 reported employment count for this occupational
group is approximately 5.96 million, with average loaded wages of
$114.42 per hour at the national level.\423\
---------------------------------------------------------------------------
\423\ U.S. Bureau of Labor Statistics, May 2022 National
Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm. The average loaded wage for Healthcare
Diagnosing or Treating Practitioners is derived by multiplying the
mean hourly rate by 200 percent to include the mean hourly wage, the
cost of fringe benefits and overhead costs ($57.21 * 200% =
$114.42).
---------------------------------------------------------------------------
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 2.95 million employed
individuals with average loaded wages of $51.18 per hour at the
national level.\424\ 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.
---------------------------------------------------------------------------
\424\ U.S. Bureau of Labor Statistics, May 2022 National
Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------
The third category of health care staff that the Department assumes
will receive training comprises non-degreed medical assistants
(Occupation code 31-0000), which includes psychiatric and home health
aides, orderlies, dental assistants, and phlebotomists. Health care
support staff (non-degreed, medical assistants) operate in the same
medical disciplines as technicians, but often lack professional degrees
or certificates often required for degreed technical staff. There are
approximately 6.79 million employed individuals in these occupations in
the health care and social assistance sector, with average loaded wages
of $34.20 per hour at the national level.\425\
---------------------------------------------------------------------------
\425\ U.S. Bureau of Labor Statistics, May 2022 National
Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------
The fourth category of health care staff that the Department
assumes will receive training is health care managers (Occupation code
11-9111) and accounts for approximately 0.48 million employed
individuals with average loaded wages of $123.06 per hour at the
national level.\426\
---------------------------------------------------------------------------
\426\ U.S. Bureau of Labor Statistics, May 2022 National
Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------
The fifth category of health care staff that the Department assumes
will receive training is office and administrative assistants
(Occupation code 43-0000) and accounts for approximately 2.719 million
employed individuals with average loaded wages of $41.16 per hour
within the Health Care and Social Assistance sector.\427\ 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. The Department assumes that outreach workers
are included in the five categories listed above.
---------------------------------------------------------------------------
\427\ U.S. Bureau of Labor Statistics, National Industry-
Specific Occupational Employment and Wage Estimates, Sector 62-
Health Care and Social Assistance, https://www.bls.gov/oes/current/naics2_62.htm#43-0000.
---------------------------------------------------------------------------
The Department estimates that there are a total 18.9 million
employees at covered entities, of which we assume 14.2 million, 75
percent, would receive training attributable to the final rule. Across
the five occupation categories, we estimate a weighted hourly wage rate
of $32.70, or a weighted fully loaded hourly wage rate of $65.41.
Assuming that the average training takes one (1) hour and adopting a
value of time based on fully loaded wage rates, we estimate total
first-year training costs for all covered entities to be approximately
$927.3 million \428\ As a sensitivity analysis, we considered the
scenario of covered entities providing training to all employees, 18.9
million, not just employees who interact with the public, 14.2 million.
Under this scenario, the total cost of training would increase to about
$1.2 billion. These costs are likely overstated since this training may
supplement or replace expected annual or other ongoing training
activities at covered 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 final rule.
---------------------------------------------------------------------------
\428\ Numbers may not multiply due to rounding.
---------------------------------------------------------------------------
Lastly, the Department assumes that 91 investigators at OCR, who
are equivalent to GS-12 Step 1 employees
[[Page 37680]]
and whose average hourly loaded wage is $65.46, will receive a one-time
training during the first year of the promulgation of this rule.\429\
Each individual would receive 8 hours of training for a total of
$47,655 (91 x 1 x $65.46) in training costs. This training would not
occur in any subsequent years.
---------------------------------------------------------------------------
\429\ U.S. Off. of Personnel Mgmt., Salary Table 2022-GS. GS-12
Step 1 Employee, https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2022/GS_h.pdf/.
---------------------------------------------------------------------------
In addition to the first-year training costs, we anticipate that
the final rule would result in additional costs associated with ongoing
training, including annual refresher training for returning employees
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 final 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
final rule scenario, we take the difference between the share of
employees receiving training under the baseline scenario and the final
rule scenario. We carry through an assumption from the 2016 RIA, which
assumed that 50 percent of total employees at covered entities receive
training and compare this to an assumption in this final RIA that 75
percent of total employees at covered entities would receive training.
This yields an estimate of 25 percent of total employees at covered
entities that would receive training in subsequent years under the
final rule. We adopt the same weighted hourly wage estimate, number of
employees, and estimate the total ongoing annual training costs as
$309.1 million. This was calculated by multiplying the total number of
employees at covered entities by .25 and multiplying by $65.41.
Finally, the Department assumes covered entities may require
employees to undergo one (1) hour of training in response to in OCR
investigation. As it is difficult to determine the type of employee
that would be required go through additional training, we use the
average loaded hourly wage of $65.41 to evaluate the opportunity cost
of training time. To estimate the frequency with which covered entities
may assume this cost, we reviewed OCR complaints from the 2023 calendar
year and identified 60 cases investigated under section 1557 that were
closed with a covered entity either engaging in voluntary corrective
action in response to the investigation or entering into a Voluntary
Resolution Agreement with the agency.\430\ Using this as a baseline,
the Department assumes that for every year of the observation period
there would be 60 potential instances of this additional training, and
that it would be conducted in each case. As a result, we estimate that
covered entities would incur $3,924 in additional training costs for
every year of the observation period.\431\
---------------------------------------------------------------------------
\430\ U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
Complaints Closed During Calendar Year 2023 within the Section 1557
Program Area.
\431\ $3,924 = ($65.41 x 1 x 60).
---------------------------------------------------------------------------
Revising Policies and Procedures
As discussed above in the previous section, the Department
anticipates that all covered entities, or approximately 266,297
entities, would revise their policies and procedures under the final
rule, with approximately half of these entities requiring less
extensive 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 (3)
would be spent by a mid-level manager equivalent to a first-line
supervisor (Occupation code 43-1011), at a cost of $62.98 ($31.49 x 2)
per hour after adjusting for the cost of fringe benefits and other
indirect costs, while an average of one (1) hour would be spent by
executive staff equivalent to a general and operations manager
(Occupation code 11-1021), at a cost of $118.14 ($59.07 x 2) per hour
at the national level, including the cost of fringe benefits and other
indirect costs.\432\ For covered entities with less extensive
revisions, we assume two (2) total hours spent on revisions per entity.
Of these, one (1) would be spent by a mid-level manager, and one (1)
would be spent by executive staff.
---------------------------------------------------------------------------
\432\ U.S. Bureau of Labor Statistics, Occupational Employment
and Wages, May 2022, 43-1011 First-Line Supervisors of Office and
Administrative Support Workers, https://www.bls.gov/oes/current/oes431011.htm.
---------------------------------------------------------------------------
We monetize the time spent on revising policies and procedures by
estimating a total cost per entity of $307.08 or $181.12, depending on
the extent of the revisions. For the 133,149 covered entities with more
extensive revisions, we estimate a total cost of about $40.8 million.
For the 133,149 covered entities with less extensive revisions, we
estimate a total cost of about $24.1 million. We estimate the total
cost associated with revisions to policies and procedures under the
final rule of $65.0 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. We are unable to precisely
estimate the total number of covered entities that would choose to
revise their policies and procedures under the new regulation or to
what extent they would make these changes due to the wide range of
types and sizes of covered entities, from complex multi-divisional
hospitals to small neighborhood clinics and physician offices.
In addition to the initial revisions of policies and procedures,
the Department assumes some covered entities may elect or be required
to revise their policies and procedures following an investigation. We
assume that such revisions would cost the same as the original revision
that occurs in the first year of the observation period. As discussed
above, the Department estimates that during every year of the
observation period, there would be an average of 60 instances in which
corrective actions may be taken due to a 1557 investigation. As
revising policies and procedures is a more significant corrective
action compared to corrective training, the Department assumes that it
will occur in response to only half of the investigations. The
Department continues to use the assumption that half of the entities
revising their policies and procedures would be major firms while the
other half would be minor firms. The estimated total annual cost for
revisions of policies and procedures in response to an OCR
investigation is $7,323 (307.08 x 15 + 181.12 x 15) in each year of the
observation period.
Notices
The final rule requires the 266,297 covered entities to provide a
Notice of Nondiscrimination to participants, enrollees, and
beneficiaries, hereafter referred to as beneficiaries of its health
program or activity, and members of the public. It also requires
covered entities to provide a Notice of Availability. These provisions
resemble elements of the 2016 Rule that were repealed in the 2020 Rule;
however, the approach under the final 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.
[[Page 37681]]
The Notice of Availability is also required in the following
electronic and written communications related to the covered entity's
health programs and activities: (1) notice of nondiscrimination
required by final 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 an individual's rights, eligibility benefits,
or services that require or request a response from a beneficiary; (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)
communications related to the cost and payment of care with respect to
an individual, including good faith estimates and medical billing and
collections materials; (10) complaint forms; and (11) patient and
member handbooks.
For the purposes of the Notice of Availability 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 of
Availability 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 of Availability requirement is
essential in this context to ensure timely and equitable access to
appeals processes. The final rule at Sec. 92.11(d) permits covered
entities to provide individuals with the option to opt out of receiving
the Notice of Availability on an annual basis, which will reduce the
cost and burden associated with these requirements. In addition, as
beneficiaries increasingly elect to receive EOBs and other types of
communications 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 final rule. These estimates are intended to encompass all
categories of Notices of Availability required under the final rule. We
have increased the total number of communications containing notices by
10 percent to account for the additional communications related to the
cost and payment of care with respect to an individual, including good
faith estimates and medical billing and collections materials, which
were not included in the Proposed Rule.\433\
---------------------------------------------------------------------------
\433\ This reflects the increase from 10 categories accounted
for by communications and notices in the Proposed Rule RIA to 11
categories, or an increase of 10 percent.
---------------------------------------------------------------------------
Table 3 below reports the number of communications containing
notices anticipated under the final 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.\434\ We explore the 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
2022 price levels using the Implicit Price Deflator, resulting in a
primary per-unit cost estimate of about $0.067 and a full range of
about $0.045 to $0.37.\435\ Combining these per-unit cost estimates
with the count of each notice results in a primary estimate of $93.2
million, with a range of estimates between $57.2 million and $522.8
million. Following the approach in the 2020 RIA, we adjust this figure
downward by 50 percent 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 insurance
issuer or plan in the last year when viewing an online statement.\436\
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 $46.6 million, with a range of
costs between $28.6 million and $261.4 million. These costs would occur
in each year of the time horizon of the analysis.
---------------------------------------------------------------------------
\434\ U.S. Dep't of Health & Hum. Servs., Food & Drug Admin.,
Electronic Distribution of Prescribing Information for Human
Prescriptions Drugs, Including Biological Products, Proposed Rule,
79 FR 75506 (Dec. 18, 2014).
\435\ Fed. Reserve Bank of St. Louis, Gross Domestic Product:
Implicit Price Deflator (GFPDEF), https://fred.stlouisfed.org/series/GDPDEF.
\436\ Saurabh Gupta et al., HFS Rsch. & Cognizant, Health
Consumers Want Digital: It's Time for Health Plans to Deliver, p. 4
(2021), https://www.cognizant.com/en_us/general/documents/cognizant-hfs-health-consumers-want-digital-its-time-for-health-plans-to-deliver.pdf.
Table 3--Cost of Notice Provisions
[2022 Dollars]
----------------------------------------------------------------------------------------------------------------
Cost scenario ($ millions)
Cost element Count -----------------------------------------------
(millions) Low Primary High
----------------------------------------------------------------------------------------------------------------
Eligibility and enrollment communications....... 19.5 $0.8 $1.3 $7.2
Annual notice of benefits....................... 135.3 5.5 8.9 49.9
Explanations of benefits--hospital admissions... 105.6 4.3 6.9 39.0
Explanations of benefits--physician visits...... 1035.1 41.8 68.1 382.0
Medical bills--hospital admissions.............. 12.1 0.5 0.8 4.5
Medical bills--physician visits................. 108.9 4.4 7.2 40.2
Total, Unadjusted............................... 1416.5 57.2 93.2 522.8
Total, Adjusted for Electronic Delivery......... 1133.2 28.6 46.6 261.4
----------------------------------------------------------------------------------------------------------------
[[Page 37682]]
Documentation Requirements
The final rule requires covered entities to contemporaneously
document certain other activities performed under the final rule. This
includes activities such as employees' completion of the training
required by this section in written or electronic form. The final 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 (63,950) spending 10 hours to store
complaints and the associated records required under final Sec.
92.8(c)(2) each year.\437\ We assume that administrative or clerical
support personnel would perform these functions. The mean hourly wage
for this occupation is $19.02 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
$24.3 million annually ($19.02 x 2 x 10 x 63,950). This estimation
approach will overstate the costs if many covered entities already
retain complaint information.
---------------------------------------------------------------------------
\437\ This estimate is consistent with the 2016 Rule's
Regulatory Impact Analysis: ``Of the 275,002 covered entities,
approximately 15 percent 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 $19.02 per hour,
which we double to account for overhead and other indirect costs. We
estimate the costs of documenting employee training would be $12.6
million in the first year ($19.02 x 2 x 1.25 x 266,297) and $10.1
million in subsequent years ($19.02 x 2 x 1 x 266,297).
Coverage for Gender-Affirming 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-affirming 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. The likelihood of
significant costs is low both because transgender individuals make up a
very small percentage of the population and because many transgender
individuals do not seek gender-affirming surgeries or other types of
care.\438\
---------------------------------------------------------------------------
\438\ See, e.g., U.S. Health & Hum. Servs., Ctrs. for Medicare &
Medicaid Servs., Colorado 2023 EHB-Benchmark Plan Actuarial Report,
https://www.cms.gov/CCIIO/Resources/Data-Resources/ehb. Suite of
Gender-affirming care benefits to treat gender dysphoria resulted
cost estimate was 0.04 percent of the total allowed claims assuming
utilization would be for adults.
---------------------------------------------------------------------------
In April 2012, the California Department of Insurance conducted an
Economic Impact Assessment on Gender Nondiscrimination in Health
Insurance that found that prohibiting discrimination on the basis of
gender identity in health insurance plans would have an ``insignificant
and immaterial'' impact on costs.\439\ This conclusion was based 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 percent and 0.0173 percent.\440\ 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.\441\ 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.\442\ The Assessment
notes the experience of one employer that initially established premium
surcharges to cover the anticipated cost of gender-affirming 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.\443\ 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.'' \444\ 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-affirming care
benefits to members of the military would result in an annual increase
of 0.012 percent of health care costs, ``little more than a rounding
error in the military's $47.8 billion annual health care budget.''
\445\ A 2013 study of 34 public and private sector employers that
provided nondiscriminatory health care coverage found that providing
coverage of gender-affirming care had ``zero to very low costs.'' \446\
An
[[Page 37683]]
additional study comparing costs and potential savings associated with
covering gender-transition-related care concluded that ``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 percent of simulations.''
\447\ More recently, a 2021 survey of employers conducted by the Human
Rights Campaign noted that most employers who covered gender-affirming
care reported only ``marginal increases'' in cost, on the order of ``a
fraction of a decimal point of cost calculations.'' \448\
---------------------------------------------------------------------------
\439\ State of Cal., Dep't of Ins., Economic Impact Assessment
Gender Nondiscrimination in Health Insurance, p. 1 (Apr. 13, 2012),
http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
\440\ Id. at p. 3. More recent estimates indicate that a higher
share of the population in the United States identifies as
transgender (0.6 percent 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.
\441\ State of Cal., Dep't of Ins., Dep't of Ins., Economic
Impact Assessment Gender Nondiscrimination in Health Insurance, p. 8
(Apr. 13, 2012), http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
\442\ State of Cal., Dep't of Ins., Economic Impact Assessment
Gender Nondiscrimination in Health Insurance, p. 9 (Apr. 13, 2012),
http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
\443\ State of Cal., Dep't of Ins., Economic Impact Assessment
Gender Nondiscrimination in Health Insurance, pp. 6-7 (Apr. 13,
2012), http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
\444\ Wis., Dep't of Employee Trust Funds, Correspondence
Memorandum Re: Transgender Services Coverage, pp. 6-8 (Aug. 14,
2018), https://etf.wi.gov/boards/groupinsurance/2018/08/22/item6a1/download?inline=.
\445\ 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.
\446\ Jody Herman, The Williams Inst., UCLA Sch. of Law, Cost
and Benefits of Providing Transition-Related Health Care Coverage in
Employee Health Benefits Plans: Findings from a Survey of Employers,
p. 2 (Sept. 2013), http://williamsinstitute.law.ucla.edu/wp-content/uploads/Herman-Cost-Benefit-of-Trans-Health-Benefits-Sept-2013.pdf.
\447\ 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 Gen.
Internal Med. 394 (2015), https://pubmed.ncbi.nlm.nih.gov/26481647/.
\448\ Hum. Rts. 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 legal challenges to coverage exclusions have
also considered issues of cost and concluded that covering gender-
affirming 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.'' \449\ Another court
reviewing expert testimony called any cost savings from excluding
coverage for gender-affirming care ``both practically and actuarially
immaterial.'' \450\
---------------------------------------------------------------------------
\449\ Boyden v. Conlin, 341 F. Supp. 3d 979, 1000 (W.D. Wis.
2018).
\450\ Flack v. Wis. 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 (finding that the cost of covering
gender-affirming care ``pales in comparison'' to the Defendant state
health plan's overall cash balance and that excluding such coverage
would only save each plan member' ``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. We reiterate that the final rule does not mandate the
provision or coverage of gender-affirming care, or any particular
health service. However, to the extent a covered entity provides
coverage for a particular health service, the covered entity must
provide the health service to all individuals in a neutral,
nondiscriminatory manner consistent with this rule. The utilization
rate of covered services, whatever those services may be, is likely to
be extremely low because transgender individuals represent a small
minority in the general population and because not all transgender
individuals will seek medical care in the course of their
transition.\451\
---------------------------------------------------------------------------
\451\ State of Cal., Dep't of Ins., Economic Impact Assessment
Gender Nondiscrimination in Health Insurance, pp. 2, 5 (Apr. 13,
2012), http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
---------------------------------------------------------------------------
As described in this section, the costs associated with gender-
affirming care are likely to be small on a percentage basis of total
health care costs; 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 percent of incremental health
care costs with $4,255.1 billion in total health expenditures in
calendar year 2021.\452\ When this is grown to 2022 dollars, total
health care costs are $4,550.0 billion. Combining these yields our
upper-bound estimate of $546 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.\453\ For our primary
estimate, we start with the midpoint of the lower-bound and upper-bound
cost estimate of about $273.24 million annually. We reduce this figure
by half to account for several factors, such as some covered entities
already covering gender-affirming care under the baseline scenario. The
coverage from Sec. 92.207(b)(1) through (5) and (6) have delayed
applicability dates of the first day of the first plan year beginning
on or after January 1, 2025. Therefore, there is no cost from coverage
in year 1 (2024). This results in a primary estimate of about $138
million per year starting in year 2 in incremental annual costs
associated with additional coverage under the final rule, with a full
range of cost estimates including $0 million and $546 million.
---------------------------------------------------------------------------
\452\ U.S. Dep't of Health & Hum. Servs., Ctrs. for Medicare &
Medicaid Servs., Table 19. National Health Expenditure Accounts:
Methodology Paper, 2022, https://www.cms.gov/files/document/definitions-sources-and-methods.pdf.
\453\ 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 Gen.
Internal Med. 394 (2015), https://pubmed.ncbi.nlm.nih.gov/26481647/.
---------------------------------------------------------------------------
In addition, health plans and issuers could incur overall costs if
total health care utilization increases as a result of this final rule.
Any potential increase in costs as a result of increased health care
utilization as a result of decreased discrimination could be passed on
to beneficiaries in the form of increased premiums. However, this cost
would be minimal due to the low utilization of gender affirming care
along with the availability of the services.
Assessing Decision Support Tools for Discrimination
Section 92.210 sets a minimum requirement for each covered entity
to make reasonable efforts to mitigate the risk of discrimination
resulting from the covered entity's use of a decision support tool.
This will impose a cost on covered entities to review for potential
discrimination in their decision support tools and to then make
reasonable steps to mitigate the risk of discrimination. To estimate
the cost of review, the Department assumes that all covered entities,
or 266,297 entities, would on average take 1 hour to review decision
support tools in year 1 and 0.5 hours in each year 2-5. The Department
assumes the time burden is halved after year 1 because entities would
only be reviewing new decision support tools or changes made to
preexisting ones in the past year. Evidence suggests that larger
entities, such as insurers, health systems and national labs, are more
likely to use decision support tools while some types of entities may
not use them at all.\454\ It is therefore likely that entities will
have a large variance in time burden in practice as some entities will
need to spend more time reviewing and others much less. OCR assumes
that the hour of review consists of a 1557 coordinator (SOC code 43-
4071) spending 0.5 hours coordinating a request for information on the
potential for discrimination in decision support tools used by the
covered entity and a Management Analyst (13-1111) or equivalent
employee with knowledge of the decision support tools spending 0.5
hours responding to that request. After adjusting for fringe benefits
and other indirect costs, the hourly wages for the Management Analyst
and Section 1557 Coordinator come to $100.64 and $38.04 respectively.
We monetize the time spent on reviewing decision support tools by
estimating a total cost per entity
[[Page 37684]]
of $69.34 ($100.64 x 0.5 + $38.04 x 0.5). The estimated total cost to
review decision support tools for all covered entities is $18,465,034
($69.34 x 266,297) in year 1. In years 2-5, OCR estimates that the time
burden will be half of what it was in year 1. This will lead to a total
cost per entity of $34.67 ($100.64 x 0.25 + $38.04 x 0.25) in years 2-
5. The estimated total cost to review decision support tools for all
covered entities is $9,232,517 ($34.67 x 266,297) in each year 2-5.
---------------------------------------------------------------------------
\454\ Xia Jing et al., Availability and Usage of Clinical
Decision Support Systems (CDSSs) in Office-Based Primary Care
Settings in the USA, BMJ Health Care Inform. (2019), https://pubmed.ncbi.nlm.nih.gov/31818828.
---------------------------------------------------------------------------
If an entity reviews their decision support tools and determines
that there is no evidence that use of the tools may result in
discriminatory outputs, then it is likely that no further action will
be taken, and no additional cost will be incurred. If the entity
determines that there is evidence that the decision support tools used
by the covered entity could result in discriminatory outputs, then the
entity will have to make reasonable mitigation steps to be in
compliance with the final rule. OCR has determined that there are a
large variety of actions that a covered entity can take to satisfy the
requirements of the final rule and that these steps likely depend on
the specific scenario. One aspect that will affect what a covered
entity would do is if the decision support tool that is being used is a
third-party product that the covered entity pays for or was developed
and is owned by the covered entity itself. In the first scenario, the
covered entity could notify the third party that the decision support
tool may result in outputs that could be in violation of the rule, take
mitigation steps in the use of the tool to ensure decisions made using
that tool account for the potential for bias, or switch to a different
product if the cost to do so is not prohibitive. If the covered entity
maintains their own decision support tool, then they might take time to
update the decision support tool, change policies and procedures about
its use, or take other reasonable mitigation measures to ensure that it
is not used in a discriminatory manner. The cost of all these actions
may vary greatly, and OCR does not have data to assess what the costs
may be. Generally, OCR assumes that larger entities, such as
multihospital health systems and insurers will have a higher cost to
resolve these issues since they are more likely to use decision support
tools.\455\ In addition, OCR does not have data on how likely any given
decision support tool is to be discriminatory and therefore necessitate
taking reasonable mitigation steps. Due to these data limitations, OCR
does not quantify the cost of taking reasonable mitigation steps.
---------------------------------------------------------------------------
\455\ Robert. S. Rudin & Shira H. Fischer, Trends in the Use of
Clinical Decision Support by Health System-Affiliated Ambulatory
Clinics in the United States 2014-2016, Am. J. of Accountable Care
(2019), https://www.ajmc.com/view/trends-in-the-use-of-clinical-decision-support-by-health-system-affiliated-ambulatory-clinics-in-the-united-states-20142016.
---------------------------------------------------------------------------
Exemption Requests
We also identify a cost related to covered entities submitting a
request for assurance of an exemption based on Federal conscience or
religious freedom laws. We model this potential cost associated with
exemption assurance requests as the time spent by covered entities to
(a) assess the need for an exemption; (b) write the exemption assurance
request; and (c) submit such a 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
assurance 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 $70.55 per hour for each
employee, which we double to account for overhead and other indirect
costs. We multiply these factors together and estimate the cost per
exemption request of $987.70 ($141.10 x 7 = $70.55 x 2 x 7).
OCR has revised the estimate of the number of religious exemptions
from the Proposed Rule RIA, which assumed 27 religious exemptions. OCR
has increased this estimate to provide a more conservative estimate of
the cost of religious exemptions, given significant uncertainty in the
number of requests that will be submitted. OCR revises its assumptions
to assume that 707 religious hospitals and 2 percent of all other
covered entities will request assurance of religious exemptions. This
results in a total of 6,019 of such requests (707 + ((266,297-707) x
0.02)) in the first year. OCR estimates the cost to covered entities
for the 6,019 of such requests as $5,944,792 (6,019 x $987.73).
We estimate the cost to OCR comprising the time it would take to
review the request and determine if the exemption assurance should be
given. We estimate that it would take a single lawyer equivalent
employee (Occupation code 23-1011), with a wage of $70.55 per hour, 3
hours to complete this review. We double the mean hourly wage to
account for overhead and fringe benefits. OCR estimates the cost to
review 6,019 assurance of exemption requests as $2,547,768 ($141.10 x 3
x 6,019). The total estimated cost of this process is $8,492,559.
c. Total Quantified Costs
Table 4 below presents the total annual costs anticipated under the
final rule for which estimates have been developed. For the purposes of
this analysis, we assume that the regulatory requirements begin to take
effect in the middle of 2024. In the first year under the final rule,
these estimated costs include $927.4 million in training, $8.5 million
to process religious assurance of exemption requests, $18.5 million to
review decision support tools, and $65.0 million to revise policies and
procedures. For all years in the analysis, we estimate recurring costs
of $46.6 million related to notices. We estimate a first-year cost of
$37 million related to documentation, with ongoing costs in future
years of $10.1 million. We also report a primary recurring cost
estimate of $136.6 million associated with coverage of gender-affirming
care starting in year 2 and $9.2 million in reviewing decision support
tools starting in year 2. The total costs in year 1 amount to $1,102.9
million, with ongoing annual costs of $511.7 million in subsequent
years.
Table 4--Primary Estimate of Total Annual Costs
[$ Millions, 2022 dollars]
----------------------------------------------------------------------------------------------------------------
Cost element 2024 2025 2026 2027 2028
----------------------------------------------------------------------------------------------------------------
Training....................................... $927.4 $309.1 $309.1 $309.1 $309.1
Policies and Procedures........................ 65.0 0.0 0.0 0.0 0.0
Notices........................................ 46.6 46.6 46.6 46.6 46.6
Documentation.................................. 37.0 10.1 10.1 10.1 10.1
Gender-affirming Care Coverage................. 0 136.6 136.6 136.6 136.6
[[Page 37685]]
Assurance of Exemption Requests................ 8.5 0.0 0.0 0.0 0.0
Decision Support Tool Review................... 18.5 9.2 9.2 9.2 9.2
----------------------------------------------------------------
Total Costs *.............................. 1,102.9 511.7 511.7 511.7 511.7
----------------------------------------------------------------------------------------------------------------
This rulemaking also revises the Department's interpretation of
whether Medicare Part B payments constitute Federal financial
assistance by answering that question in the affirmative. Thus, the
requirements of section 1557 and other civil rights statutes apply to
entities that receive payments through Medicare Part B. We are
currently unable to quantify the number of covered entities that are
enrolled in Medicare 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
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.\456\
---------------------------------------------------------------------------
\456\ 81 FR 31375, 31445-46 (May 18, 2016).
---------------------------------------------------------------------------
3. Discussion of Benefits
Quantifying benefits for this final 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 final
rule, and thus are unable to quantify or monetize these health
improvements. Similarly, we anticipate that the final 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.\457\
---------------------------------------------------------------------------
\457\ State of Cal., Dep't of Ins., Economic Impact Assessment
Gender Nondiscrimination in Health Insurance, pp. 9-11 (Apr. 13,
2012), http://translaw.wpengine.com/wp-content/uploads/2013/04/Economic-Impact-Assessment-Gender-Nondiscrimination-In-Health-Insurance.pdf.
---------------------------------------------------------------------------
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, interpretation of the
Supreme Court's Bostock decision, and the Department's Bostock
Notification. The training provisions represent one mechanism by which
the final 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 that beneficiaries could benefit from reduced
obstacles to accessing health care, including fewer language barriers
and a reduction in discriminatory behavior related to sexual
orientation and gender identity, resulting in a potential increase in
overall health care utilization. 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 individuals with
LEP 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 assurance
of an exemption based on Federal conscience or religious freedom laws
will result in benefits from reduced litigation, which we do not
capture in the benefit analysis. In addition, the prohibition on
discrimination through the use of decision support tools is also likely
to have a direct benefit on the health of individuals who are suffering
from delayed or denied medical care due to discriminatory application
of decision support tools. An example of this would be an incorrect
diagnosis for skin cancer for a Black patient, which could lead to
greater medical costs in the future and negative health outcomes for
the patient.\458\ Furthermore, the positive effects of using decision
support tools, such as identifying those at risk for cardiovascular
disease at an earlier date, will be a benefit across populations
experiencing discrimination.\459\
---------------------------------------------------------------------------
\458\ Thomas Grote & Geoff Keeling, On Algorithmic Fairness in
Medical Practice, Cambridge Quarterly of Healthcare Ethics, January
2022. https://pubmed.ncbi.nlm.nih.gov/35049447/.
\459\ Rachel Gold et al., Effect of Clinical Decision Support at
Community Health Centers on the Risk of Cardiovascular Disease: A
Cluster Randomized Clinical Trial, JAMA Network Open (2022), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2788645.
---------------------------------------------------------------------------
4. Analysis of Regulatory Alternatives to the Final Rule
The Department considered various alternatives while developing
this regulation, including adopting the compliance timeline of the
Proposed Rule. As discussed in the preamble, the final rule will allow
additional time for covered entities to comply with certain procedural
requirements, as compared to the timeline of the Proposed Rule. For
example, covered entities must comply with the Sec. 92.9 Training
requirements by no later than 300 days of effective
[[Page 37686]]
date. This revised timeline will postpone certain costs incurred by
covered entities; however, since this analysis reports annual impacts,
the revised timeline does not affect the quantified cost estimates.
This section discusses several other alternatives OCR considered.
The Department analyzed several regulatory alternatives to the
final rule related to the notice requirements. The first alternative
considered retaining the 2020 Rule's 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 final rule would cost covered
entities, as an aggregate, $46.6 million for each year. While excluding
the provisions relating to the notices would reduce the cost of the
final rule by $46.6 million, the Department rejected this option
because it believes that the final provisions strike an appropriate
balance between providing greater access for beneficiaries, while
maximizing efficiency and economies 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 5 above. Under our primary cost scenario, this policy
alternative would result in annual costs of notices of $0.7 million,
which is about $45.9 million lower than the final rule. The Department
rejected this option however, because this policy alternative, while
posing a significantly reduced cost and 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 3.2 billion annual pharmacy-related notices. This would
result in $169.7 million in costs per year, or an increase of $123.1
million compared to the final 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 assurance of a religious or
conscience exemption. As described in the cost section, we estimate
that this policy alternative would reduce the quantified costs by $8.5
million. The Department did not choose this alternative because of its
obligations to enforce a range of statutory protections, including
Federal religious freedom and conscience laws. OCR remains committed to
educating patients, providers, and other covered entities about their
rights and obligations under these statutes, to protecting patients'
health and dignity, and to providing a clear administrative process
that respects the right to raise objections to the provision of certain
kinds of care.
We have not quantified the benefits associated with this
information for the final rule or for these policy alternatives.
Table 5 reports the total costs of these policy alternatives in
present value and annualized terms, adopting a 3 percent and 7 percent
discount rate. Table 6 reports the difference between the total cost of
the alternatives compared to the provisions of the final rule, using
the same accounting methods and discount rates. All estimates are
presented in millions of year-2022 dollars, using 2024 as the base year
for discounting.
Table 5--Total Cost of Policy Alternatives Considered
[$ Millions, 2022 dollars]
----------------------------------------------------------------------------------------------------------------
Present value Annualized
Accounting method discount rate ---------------------------------------------------------------
3% 7% 3% 7%
----------------------------------------------------------------------------------------------------------------
Final Rule...................................... $2,917.6 $2,650.8 $637.1 $646.5
Alternative 1: No Notice Provision.............. 2,704.1 2,459.7 590.5 599.9
Alternative 2: Single Notice Provision.......... 2,707.4 2,462.6 591.2 600.6
Alternative 3: Pharmacy-Related Notices......... 3,481.3 3,155.4 760.1 769.6
Alternative 4: No Exemption Provision........... 2,909.4 2,642.8 635.3 644.6
----------------------------------------------------------------------------------------------------------------
Table 6--Comparison of Alternatives to Final Rule
[$ Millions, 2022 dollars]
----------------------------------------------------------------------------------------------------------------
Present value Annualized
Accounting method discount rate ---------------------------------------------------------------
3% 7% 3% 7%
----------------------------------------------------------------------------------------------------------------
Alternative 1: No Notice Provision.............. -$213.5 -$191.1 -$46.6 -$46.6
Alternative 2: Single Notice Provision.......... -210.2 -188.2 -45.9 -45.9
Alternative 3: Pharmacy-related Notices......... 563.7 504.6 123.1 123.1
Alternative 4: No Exemption Provision........... -8.2 -7.9 -1.8 -1.9
----------------------------------------------------------------------------------------------------------------
[[Page 37687]]
The Department also considered whether to require covered entities
to collect the self-identified race, ethnicity, primary language
(spoken and written), sex (consistent with the categories of sex
discrimination described at Sec. 92.101(a)(2)), age, and disability
status data for beneficiaries 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 the ability to collect these data to ensure compliance.\460\
---------------------------------------------------------------------------
\460\ See, e.g., 45 CFR 80.6, 86.71, 91.34, and 84.61.
---------------------------------------------------------------------------
B. Regulatory Flexibility Act--Final Small Entity Analysis
The RFA requires agencies issuing a regulation to analyze options
for regulatory relief of small businesses if a rule will have a
significant impact on a substantial number of small entities. The RFA
generally defines a ``small entity'' as:
(1) A proprietary firm meeting the size standards of the Small
Business Administration (SBA);
(2) A nonprofit organization that is not dominant in its field; or
(3) A small government jurisdiction with a population of less than
50,000 (States and individuals are not included in the definition of
``small entity'').
OCR uses as its measure of significant economic impact on a
substantial number of small entities a change in revenues of more than
3 percent for 5 percent or more of affected small entities. In
instances where OCR judged that the final rule would have a significant
impact on a substantial number of small entities, we considered
alternatives to reduce the burden. To accomplish our task, we first
identified all the small entities that may be impacted, and then
evaluated whether the economic burden we determined in the RIA
represents a significant economic impact.
1. Entities That Will Be Affected
OCR has traditionally classified most providers as small entities
even though some nonprofit providers would not meet the definition of
``small entity'' were they proprietary firms. Nonprofit entities are
small if they are independently owned and operated and are not dominant
in their fields. The CMS Provider of Service file has indicators for
profit and nonprofit entities, but these have proven to be unreliable.
The Census data identifies firms' tax status by profit and non-profit
status but only reports revenues and does not report them by the profit
and non-profit status of the entity.
a. Physicians
One class of providers we do not automatically classify as small
businesses is physician practices. Physician practices are businesses
and therefore are ``small'' if they meet the SBA's definition. The
current size standard for physicians (excluding mental health
specialists) (North American Industry Classification System code 62111)
is annual receipts of less than $16 million.\461\ Using the Census data
showing the number of firms, employees and payroll, we selected
physicians that reported fewer than 20 employees as the top end for
small physician offices. This equaled 16,361 entities or 9.8 percent of
all physician offices defined as ``large.'' This left 150,933 offices
or 90.2 percent as ``small.'' \462\
---------------------------------------------------------------------------
\461\ U.S. Small Business Admin., Table of Small Business Size
Standards Matched to North American Industry Classification System
Codes, Small Business Administration (March 2023), https://www.sba.gov/document/support-table-size-standards.
\462\ Physician practices may earn more than $16 million per
year and that would increase the number of ``large'' practices in
the analysis. But as we will later show, large practices will have
proportionally larger workforce staff that must be excluded from the
analysis.
---------------------------------------------------------------------------
b. Pharmacies
Pharmacies also are businesses, and the size standard for them is
annual receipts of less than $37.5 million. According to Census
Statistics of U.S. Businesses, there are 19,346 pharmacy and drug store
firms (North American Industry Classification System code 456110).
Because of the lack of revenue or receipt data for pharmacies, we are
unable to estimate the number of small pharmacies based on the SBA size
standard. However, using the number of employees taken from the
Statistics of U.S. Businesses as a proxy for revenues, the data is
divided by number of employees per firm and shows the number of
employers with fewer than 20 employees and those with more than 20
employees.\463\ There are 17,160 pharmacy firms with fewer than 20
employees, representing 88.7 percent of the total number of pharmacy
firms. It seemed reasonable to assume that firms with fewer than 20
employees satisfy the SBA size standard and thus we accepted that the
number of small pharmacy firms equaled 17,160. As with the number of
small physician offices, our method can only identify the minimum
number of ``small'' pharmacies that meet the SBA size standard. We
cannot determine the actual number of ``small'' pharmacies.
---------------------------------------------------------------------------
\463\ U.S. Census Bureau, Statistics of U.S. Businesses, https://www.census.gov/programs-surveys/susb.html.
---------------------------------------------------------------------------
c. Health Insurance Issuers
Another class of covered entities that are business enterprises is
health insurance issuers. The SBA size standard for health insurance
issuers is annual receipts of $47 million. Based on the analysis below,
we conclude that there are few small health insurance issuers.
In 2021, there were 483 issuers in the U.S. health insurance
market.\464\ Health insurance issuers are generally classified under
the North American Industry Classification System (NAICS) code 524114
(Direct Health and Medical Insurance Carriers). According to SBA size
standards,\465\ entities with average annual receipts of $47 million or
less are considered small entities for this NAICS code. The Departments
expect that few, if any, insurance companies underwriting health
insurance policies fall below these size thresholds. Due to the lack of
recent Census data based on enterprise receipt size, HHS used the
Census 2017 SUSB data as a proxy since it was the last year in which
this data is available. Based on data from SUSB annual report
submissions for the 2017 SUSB reporting year, approximately 443 out of
745 issuers of health insurance coverage nationwide, approximately
59.46%, had total premium revenue of $40.0 million or less.\466\ OCR
decided to use a value slightly higher than the 2017 SBA standard to
account for slight changes in the industry in addition to inflation. We
then apply this percentage to the current number of insurance Issuers
to estimate the number of small entities for the business type, which
is approximately 517 of 869 entities. However, this estimate may
overstate the actual number of small health insurance issuers that may
be affected due to changes in the health care industry since 2017. To
produce a conservative estimate, for the purposes of this analysis, the
Departments assumes 59.5 percent, or 517 issuers are considered small
entities.
---------------------------------------------------------------------------
\464\ U.S. Health & Hum. Servs., Ctrs. for Medicare & Medicaid
Servs. (2022), Medical Loss Ratio Data and System Resources, https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.
\465\ U.S. Small Business Admin., Table of Size Standards (March
17, 2023), https://www.sba.gov/document/support--table-size-standards.
\466\ U.S. Health & Hum. Servs., Ctrs. for Medicare & Medicaid
Servs., Medical Loss Ratio Data and System Resources (2017), https://www.cms.gov/marketplace/resources/data/medical-loss-ratio-data-systems-resources.
---------------------------------------------------------------------------
d. Local Government Entities
We also excluded local governmental entities from our count of
small entities
[[Page 37688]]
because we lack the data to classify them by populations of fewer than
50,000. The following table shows the number of small, covered entities
we estimated could be affected by the final rule.
Table 8--Small Entities
------------------------------------------------------------------------
NAICS code Business type Small entities
------------------------------------------------------------------------
62142........................ Outpatient mental health 7,649
and substance abuse
centers.
621491....................... HMO medical centers...... 84
621492....................... Kidney dialysis centers.. 449
621493....................... Freestanding ambulatory 4,554
surgical and emergency
centers.
621498....................... All other outpatient care 6,307
centers.
6215......................... Medical and diagnostic 7,200
laboratories.
6216......................... Home health care services 25,718
6219......................... All other ambulatory 7,091
health care services.
62321........................ Residential intellectual 6,674
and developmental
disability facilities.
6221......................... General medical and 2,445
surgical hospitals.
6222......................... Psychiatric and substance 434
abuse hospitals.
6223......................... Specialty (except 301
psychiatric and
substance abuse)
hospitals.
6231......................... Nursing care facilities 9,824
(skilled nursing
facilities).
45611........................ Pharmacies and drug 17,160
stores.
6211......................... Offices of physicians.... 150,933
524114....................... Insurance Issuers........ 517
Navigator grantees....... 58
---------------
Total Entities........ 247,398
------------------------------------------------------------------------
2. Whether the Rule Will Have a Significant Economic Impact on Covered
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
percent impact on revenue on at least 5 percent of small entities. We
performed a threshold analysis to determine whether the quantified
impacts of the final rule will exceed these thresholds. As described
earlier in this analysis, we estimate the total annualized costs of the
final rule would be about $637.1 million. Dividing these total costs by
the 247,398 small entities gives a cost per entity of $2,575. This cost
estimate would only exceed the 3 percent ``significant impact''
threshold on revenue for any covered small businesses with revenue
below $85,836. We conclude that very few small businesses covered by
the final rule will have revenues below $85,836, and that this number
is very likely to be smaller than the 5 percent ``substantial number''
threshold.
As an additional consideration, we note that the costs of the final
rule are mostly proportional to the size of the covered entity. For
example, the costs associated with training, which account for more
than 70 percent of the total costs of the final rule, are mostly
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 percent of a full-time employee's annual labor
productivity, assuming a full-time employee works 2,080 hours per
year.\467\ This finding, that the cost of training represents 0.05
percent of the share of employees receiving training, is constant
across firm size.
---------------------------------------------------------------------------
\467\ 40 hours per week x 52 weeks = 2,080 hours. 0.05% = 0.0005
= 1 hour / 2080 hours.
---------------------------------------------------------------------------
Because the costs of the final 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 certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
C. Executive Order 12250 on Leadership and Coordination of
Nondiscrimination Laws
Pursuant to E.O. 12250, the Department of Justice 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.''The Department of Justice has reviewed and
approved this final rule.
D. Paperwork Reduction Act
Information Collection Requirements
This final rule contains information collection requirements (ICRs)
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995.\468\ In order to
evaluate whether an information collection should be approved by OMB,
the PRA requires that the Department solicits comment on the following
issues:
---------------------------------------------------------------------------
\468\ 44 U.S.C. 3501-3520.
---------------------------------------------------------------------------
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.\469\
---------------------------------------------------------------------------
\469\ 44 U.S.C. 3506(c)(2)(A).
---------------------------------------------------------------------------
The PRA requires consideration of the time, effort, and financial
resources necessary to meet the information collection requirements
referenced in this section. The Department previously published a
notice of a proposed data collection on August 4, 2022, at 87 FR 47907-
08, as part of an NPRM entitled ``Nondiscrimination in Health Programs
and Activities'' (RIN 0945-AA17), to invite public comment. OCR
solicited comment on the issues listed above for the sections that
contain ICRs. The following paragraphs describe these provisions, with
an estimate of the annual burden, summarized in Table 1. OCR did not
receive comments related to the previous notice but has adjusted the
estimated respondent burden in this request to reflect revised
assumptions based on updated information available at the time of the
final rule's
[[Page 37689]]
publication. This revision resulted in adjusted cost estimates that are
consistent with the RIA presented in this final rule. The estimates
covered the employees' time for reviewing and completing the
collections required.
Consistent with the NPRM, the collections of information proposed
by this final rule relate to Sec. Sec. 92.5 (Assurances required);
92.7 (Designation and responsibilities of a Section 1557 Coordinator);
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
collections of information, please see the Regulatory Impact Analysis.
1. ICRs Regarding Assurances (Sec. 92.5)
Section 92.5 retains the assurances obligations from the 2016 and
2020 Rules for covered entities to submit an assurance of compliance to
the Department. As stated in the NPRM, OCR has previously obtained PRA
approval (OMB control # 0945-0008) for this reporting requirement via
an update to 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 attestation of Assurance of Compliance, the
Department has determined that this requirement imposes no additional
reporting or recordkeeping requirements under the PRA.
OCR did not receive any comments in response to the ICRs related to
this policy. Please see the prior preamble discussion for our responses
to the general comments related to this provision. OCR is finalizing
this ICR as proposed.
2. ICRs Regarding Section 1557 Coordinator (Sec. 92.7) and Training
(Sec. 92.9)
Section 92.7 requires covered entities with 15 or more employees
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 was estimated in the NPRM, at an
annualized burden of 10 hours per covered entity to store complaints
and the associated records required under Sec. 92.8(c)(2) each year.
We assumed that administrative or clerical support personnel would
perform these functions. The mean hourly wage for this occupation was
$17.38 per hour, which we double to account for overhead and other
indirect costs. In the 2022 NPRM, OCR estimated the number of covered
entities with more than 15 employees to be approximately 15 percent or
41,250. Although in the 2022 NPRM, OCR estimated that 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), we noted
that this estimation approach may overstate the costs if many covered
entities already retain complaint information.
OCR has adjusted our estimated respondent burden in this request to
reflect baseline conditions based on updated information available at
the time of the final rule's publication. No changes were made to
estimated personnel or staff time or to the assumption that
administrative or clerical support personnel would perform these
functions. The mean hourly wage for this occupation, however, has
increased to $19.02 per hour, which we double to account for overhead
and other indirect costs. The Department estimates the number of
covered entities with more than 15 employees to be approximately 15
percent or 63,950. Although we estimate the costs of retaining records
related to grievances filed at all covered entities would be $24.3
million annually (($19.02 x 2) x 10 x 63,950)), this estimation
approach will overstate the costs if many covered entities already
retain complaint information.
The burden for documenting employee training as required under
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 the first year and in subsequent years. In the NPRM, we estimated
that administrative or clerical support personnel would perform these
functions. The mean hourly wage for this occupation was $17.38 per
hour. The labor cost was $6.0 million in the first year (($17.38 x
1.25) x 275,002 covered entities). In the 2022 NPRM, we estimated 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).
OCR has adjusted our estimated respondent burden in this request to
reflect updated baseline conditions based on updated information not
available at the time of the publication of the NPRM. No changes were
made to the estimated personnel or staff time or to the estimate that
administrative or clerical support personnel would perform these
functions. The mean hourly wage for this occupation, however, increased
to $19.02 per hour. The estimated labor cost of documenting employee
training would be $12.6 million in the first year (($19.02 x 2) x 1.25
x 266,297 covered entities). We estimate that the cost in subsequent
years would be $10.1 million, which would represent an annual allotment
of one (1) hour ((($19.02 x 2) x 1) x 266,297 covered entities).
OCR did not receive any comments in response to the ICRs related to
this policy. Please see the prior preamble discussion for our responses
to the general comments related to this provision. OCR is finalizing
these ICRs as proposed.
3. ICRs Regarding Notice of Nondiscrimination (Sec. 92.10) and Notice
of Availability of Language Assistance Services and Auxiliary Aids and
Services (Sec. 92.11)
Under Sec. Sec. 92.10 and 92.11, OCR requires covered entities to
notify the public of their nondiscrimination requirements, as well as
the availability of language assistance services and auxiliary aids and
services.
Section 92.10 requires covered entities to provide a Notice of
Nondiscrimination relating to its heath programs or activities to
beneficiaries of its health programs and activities and members of the
public. To minimize the 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.
Section 92.11 requires covered entities to notify the public of
their nondiscrimination requirements, as well as the availability of
language assistance services and auxiliary aids and services. A covered
entity must provide a Notice of Availability that, at minimum, states
that the covered entity provides language assistance services and
auxiliary aids and services free of charge
[[Page 37690]]
in its health programs and activities, in compliance with section 1557.
This notice must be provided to beneficiaries 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 top 15 languages spoken by
persons with LEP of the relevant State or States in which a covered
entity operates (including territories) and must be provided in
alternate formats for individuals who request auxiliary aids and
services to ensure effective communication.
OCR also received comments on the cost of Notices of
Nondiscrimination and Notices of Availability (referred to as
``taglines'' in the 2016 and 2020 Rules). One commenter explained how
the cost of including taglines averages up to $8.91 per month per
covered entity and upwards of $2 million a year for the health
insurance industry. Another commenter stated that they have spent over
$16 million on notices and taglines since 2016, and estimate that they
have spent over $3 million in 2022 alone. As we noted in the RIA,
neither commenter provided sources for their data nor additional detail
on their cost estimates. Another commenter noted that previous
complaints on the frequency and volume of materials related to the
notice and tagline sections of the rule were not addressed, but no data
were provided with their comment.
Based on costs estimated in the RIA, OCR derives a monthly cost of
Notices of Nondiscrimination and Notices of Availability from $21.28
and $26.60 per entity depending on the prevalence of electronic
delivery. These cost estimates include the total Notices of
Nondiscrimination and Notices of Availability and therefore OCR finds
the commenter's estimate of $8.91 per month for Notices of Availability
as plausible and consistent with the estimates in the RIA. OCR also
notes that these cost estimates are averages. It is expected that some
entities, including larger entities, may have higher than average costs
due to the increased number of notices they would send to individuals.
Both types of notices are required (1) on an annual basis; (2) upon
request; (3) at a conspicuous location on the homepage of the covered
entity's health program or activity website; and (4) at conspicuous
physical locations where the health program or activity interacts with
the public.
In the NPRM, OCR estimated the burden for responding to the
proposed notice requirements would be 34 minutes and that
administrative or clerical support personnel would perform these
functions. Because it was difficult to determine the exact number of
communications that would be required to contain the notices
anticipated under the 2022 NPRM, our cost estimates reflected a wide
range of uncertainty in the cost. In the 2022 NPRM, the Department
estimated an adjusted annual primary cost 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.
OCR has adjusted our estimated respondent burden in this request to
reflect updated baseline conditions based on updated information not
available at the time of the publication of the NPRM. Because it is
difficult to determine the exact number of communications that would be
required to contain the notices anticipated under the 2022 NPRM, our
cost estimates reflect a wide range of uncertainty in the cost. OCR
notes that the majority of associated costs for these requirements are
from the materials, such as paper and ink, used in the notices and
these costs are assumed to vary with the length of notices. No changes
were made to the estimate that administrative or clerical support
personnel would perform these functions. The estimated personnel and
staff time, however, increased to 1.34 hours per year to perform these
functions. The mean hourly wage for this occupation increased to $19.02
per hour, which we double to account for overhead and other indirect
costs. The estimated labor cost to notify the public of their
nondiscrimination requirements, as well as availability of language
assistance services and auxiliary aids and services, would be $13.5
million (($19.02 x 2) x 1.34) x 266,297 covered entities). The
Department estimates the total associated costs for these requirements
as an adjusted annual total of $53.2 million, with a range of costs
between $35.5 million and $292.6 million. These costs would occur in
each year of the time horizon of the analysis.
OCR did not receive any comments in response to the ICRs related to
Sec. 92.10, and received the comments discussed above in response to
ICRs related to Sec. 92.11. Please see the prior preamble discussion
for our responses to the general comments related to this provision.
OCR is finalizing the ICRs for Sec. Sec. 92.10 and 92.11 as proposed.
We have submitted a copy of this final rule to OMB for its review
of the rule's ICRs. These requirements are not effective until they
have been approved by OMB.
---------------------------------------------------------------------------
\470\ The figures in this column are averages based on a range.
Large entities with more than 15 employees may require more hours
than those provided here due to their size and complexity, while
small entities may require fewer hours to conduct certain compliance
activities.
\471\ 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 63,950 covered entities. All covered entities
would be required to document employee training on section 1557. We
estimated that this would apply to approximately 266,297 covered
entities.
\472\ 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.
\473\ The $38.04 wage, which includes $19.02 plus 100 percent
for benefits, applies to the category ``Administrative or Clerical
Support Personnel.''
\474\ 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.
Table 1--Summary of Estimated Annualized Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Responses Burden hours
Information collection Number of frequency Total per response Hourly rate Burden cost
respondents (average) responses (average) \470\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 92.7 Coordination Efforts....................... \471\ 63,950/ 1 330,247 \472\ 10/1.25 \473\ $38.04 $24,326,580/
266,297 12,662,422
Sec. Sec. 92.10 & 92.11 Notice...................... 266,297 \474\ 1 266,297 1.34 38.04 13,574,117
Total application collection........................... 330,247 .............. 596,544 12.59 .............. 50,563,119
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 37691]]
E. Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations
Act of 1999 requires Federal departments and agencies to determine
whether a proposed policy or regulation could affect family well-being.
If the determination is affirmative, then the Department or agency must
prepare an impact assessment to address criteria specified in the law.
The final rule would not negatively affect family wellbeing and
would strengthen the stability of the family by promoting the ability
of all individuals and families to receive health care free from
discrimination. As research demonstrates that experiencing
discrimination can have a negative impact on health and wellbeing, this
rule addresses the immediate and long-term effects of discriminatory
actions and establishes a set of practices to remove barriers to
accessing care among entities that receive Federal funds. Addressing
and preventing discrimination in health care can also improve the
financial stability of the family unit by increasing access to
nondiscriminatory health insurance coverage and other health-related
coverage, aiding parents in their ability to provide for and nurture
their children. The rule may be carried out only by the Federal
Government because it would implement Federal nondiscrimination law,
ensuring that American families have access to health care information
and services, regardless of the State where they are located.
List of Subjects
42 CFR Part 438
Citizenship and naturalization, Civil rights, Grant programs-
health, Individuals with disabilities
Medicaid, Reporting and recordkeeping requirements, Sex
discrimination.
42 CFR Part 440
Citizenship and naturalization, Civil rights, Grant programs-
health, Individuals with disabilities, Medicaid, Sex discrimination.
42 CFR Part 457
Administrative practice and procedure, Grant programs-health,
Health insurance, Reporting and recordkeeping requirements.
42 CFR Part 460
Aged, Citizenship and naturalization, Civil rights, Health, Health
care, Health records, Individuals with disabilities, Medicaid,
Medicare, Religious discrimination, Reporting and recordkeeping
requirements, Sex discrimination.
45 CFR Part 80
Civil rights, Individuals with disabilities, Sex discrimination,
Vocational education.
45 CFR Part 84
Civil rights, Equal educational opportunity, Equal employment
opportunity, Health care, Individuals with disabilities, Infants and
children, Reporting and recordkeeping requirements.
45 CFR Part 92
Administrative practice and procedure, Aged, Citizenship and
naturalization, Civil rights, Communications equipment, Health
facilities, Health insurance, Health programs or activities,
Healthcare, Individuals with disabilities, 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, 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.
Dated: April 18, 2024.
Xavier Becerra,
Secretary, Department of Health and Human Services.
For the reasons set forth in the preamble, the Department of Health
and Human Services amends 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; disability; or sex which includes sex characteristics,
including intersex traits; pregnancy or related conditions; sexual
orientation; gender identity; and sex stereotypes; and will not use any
policy or practice that has the effect of discriminating on the basis
of race; color; national origin; disability; or sex which includes
discrimination on the basis of sex characteristics, including intersex
traits; pregnancy or related conditions; sexual orientation; gender
identity; and sex stereotypes.
* * * * *
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 which includes sex
characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity and sex stereotypes.
* * * * *
[[Page 37692]]
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 which includes
sex characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes.
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: 42 U.S.C. 1302.
0
7. Amend Sec. 457.495 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, 1395, 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 shall not discriminate against any
participant in the delivery of required PACE services based on race,
ethnicity, national origin, religion, sex (including sex
characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes),
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 sex characteristics, including intersex traits; pregnancy or
related conditions; sexual orientation; gender identity; and sex
stereotypes), age, mental or physical disability, or source of payment.
Specifically, each participant has the right to the following:
* * * * *
Title 45--Public Welfare
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 appendix A to part 80 under part 1 by adding entry 155 in
numerical order to read as follows:
Appendix A to Part 80--Federal Financial Assistance To Which These
Regulations Apply Part 1. Assistance Other Than Continuing Assistance
to States
* * * * *
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.
0
14. Amend appendix A to part 84 in subpart a, under Definitions, by
revising section 2 to read as follows:
Appendix A to Part 84--Analysis of Final Regulation
Subpart A--General Provisions
Definitions * * *
2. ``Federal financial assistance''. In Sec. 84.3(h), defining
Federal financial assistance, a clarifying change has been made:
procurement contracts are specifically excluded. They are covered,
however, by the Department of Labor's regulation under section 503.
The Department has never considered such contracts to be contracts
of assistance; the explicit exemption has been added only to avoid
possible confusion.
The proposed regulation's exemption of contracts of insurance or
guaranty has been retained. A number of comments argued for its
deletion on the ground that section 504, unlike title VI and title
IX, contains no statutory exemption for such contracts. There is no
indication, however, in the legislative history of the
Rehabilitation Act of 1973 or of the amendments to that Act in 1974,
that Congress intended section 504 to have a broader application, in
terms of Federal financial assistance, than other civil rights
statutes. Indeed, Congress directed that section 504 be implemented
in the same manner as titles VI and IX. In view of the long
established exemption of contracts of insurance or guaranty under
title VI, we think it unlikely that Congress intended section 504 to
apply to such contracts.
* * * * *
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 effective 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 individuals with limited English
proficiency.
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.
[[Page 37693]]
92.206 Equal program access on the basis of sex.
92.207 Nondiscrimination in health insurance coverage 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 patient care decision support
tools.
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
religious freedom and conscience 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.
PART 92--NONDISCRIMINATION IN HEALTH PROGRAMS OR ACTIVITIES
Subpart A--General Provisions
Sec. 92.1 Purpose and effective 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) Effective date. The regulations in this part are effective
beginning July 5, 2024, unless otherwise provided in the following
schedule:
Table 1 to Paragraph (b)
------------------------------------------------------------------------
Section 1557 requirement and Date by which covered entities must
provision comply
------------------------------------------------------------------------
Sec. 92.7...................... Within 120 days of July 5, 2024.
Sec. 92.8...................... Within one year of July 5, 2024.
Sec. 92.9...................... Following a covered entity's
implementation of the policies and
procedures required by Sec. 92.8,
and no later than one year of July
5, 2024.
Sec. 92.10..................... Within 120 days of July 5, 2024.
Sec. 92.11..................... Within one year of July 5, 2024.
Sec. 92.207(b)(1) through (5).. For health insurance coverage or
other health-related coverage that
was not subject to this part as of
July 5, 2024, by the first day of
the first plan year (in the
individual market, policy year)
beginning on or after January 1,
2025.
Sec. 92.207(b)(6).............. By the first day of the first plan
year (in the individual market,
policy year) beginning on or after
January 1, 2025.
Sec. 92.210(b) and (c)......... Within 300 days of July 5, 2024.
------------------------------------------------------------------------
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 health program or activity administered by a title I
entity.
(b) The provisions of this part shall not apply to any employer or
other plan sponsor of a group health plan, including but not limited
to, a board of trustees (or similar body), association or other group,
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) Insofar as the application of any requirement under this part
would violate applicable Federal protections for religious freedom and
conscience, such application shall not be required. For example, 42
U.S.C. 18023 provides (among other things) that nothing in section 1557
shall be construed to have any effect on Federal laws regarding
conscience protection; willingness or refusal to provide abortion; and
discrimination on the basis of the willingness or refusal to provide,
pay for, cover, or refer for abortion or to provide or participate in
training to provide abortion.
(d) Nothing in this part shall be construed to supersede State or
local laws that provide additional protections against discrimination
on any basis described in Sec. 92.1.
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.
[[Page 37694]]
2010 Standards means 36 CFR part 1191, appendices B and D (2009),
in conjunction with 28 CFR 35.151.
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) services, as defined in 28 CFR 35.104 and 36.104;
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 an individual, a physical or
mental impairment that substantially limits one or more major life
activities of such individual; a record of such an impairment; or being
regarded as having such an impairment, as defined and construed in the
Rehabilitation Act, 29 U.S.C. 705(9)(B), which incorporates the
definition of ``disability'' in the 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, as used in this part:
(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 or clinical 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. A health program or activity
also includes all of the operations of a State Medicaid program,
Children's Health Insurance Program, and Basic Health Program.
Individual with limited English proficiency 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
individual with limited English proficiency 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).
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:
[[Page 37695]]
(1) Oral language assistance, including interpretation in non-
English languages provided in-person or remotely by a qualified
interpreter for an individual with limited English proficiency, and the
use of qualified bilingual or multilingual staff to communicate
directly with individuals with limited English proficiency;
(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.
Machine translation means automated translation, 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 ancestors', 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.
Patient care decision support tool means any automated or non-
automated tool, mechanism, method, technology, or combination thereof
used by a covered entity to support clinical decision-making in its
health programs or activities.
Qualified bilingual/multilingual staff means a member of a covered
entity's 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 individuals with limited English proficiency 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:
(1) Has demonstrated proficiency in communicating in, and
understanding:
(i) Both English and a non-English language (including American
Sign Language, other sign languages); or
(ii) Another communication modality (such as cued-language
transliterators or oral transliteration);
(2) Is able to interpret effectively, accurately, and impartially,
both receptively and expressively, using any necessary specialized
vocabulary or terms without changes, omissions, or additions and while
preserving the tone, sentiment, and emotional level of the original
statement; and
(3) Adheres to generally accepted interpreter ethics principles
including client confidentiality.
(4) Qualified interpreters include, for example, sign language
interpreters, oral transliterators, and cued-language transliterators.
Qualified interpreter for an individual with limited English
proficiency 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 (qualified
interpreters for relay interpretation must demonstrate proficiency in
two non-English spoken languages);
(2) Is able to interpret effectively, accurately, and impartially
to and from such language(s) and English (or between two non-English
languages for relay interpretation), 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; 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.
Relay interpretation means interpreting from one language to
another through an intermediate language. This mode of interpretation
is often used for monolingual speakers of languages of limited
diffusion, including select indigenous languages. In relay
interpreting, the first interpreter listens to the speaker and renders
the message into the intermediate language. The second interpreter
receives the message in the intermediate language and interprets it
into a third language for the speaker who speaks neither the first nor
the second language.
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 includes each of the several States, the District of
Columbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the
United States Virgin Islands, and the Commonwealth of the Northern
Mariana Islands.
State Exchange means an Exchange established by a State and
approved by the Department pursuant to 45 CFR part 155, subpart B.
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. Technologies include
videoconferencing, the internet, store-and-forward imaging, streaming
media, and terrestrial and wireless communications.
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.
[[Page 37696]]
Title IX means title IX of the Education Amendments of 1972 (Pub.
L. 92-318; 20 U.S.C. 1681 et seq.), as amended.
UFAS means the Uniform Federal Accessibility Standards (Pub. L. 90-
480; 42 U.S.C. 4151 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 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, a ``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, 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. (1) 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 (consistent with the scope of sex discrimination
described at Sec. 92.101(a)(2)), 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 that
provides the current contact information for the Section 1557
Coordinator required by Sec. 92.7 (if applicable).
(2) OCR considers it a best practice toward achieving compliance
for a covered entity to provide information that it has been granted a
temporary exemption or granted an assurance of exemption under Sec.
92.302(b) in the nondiscrimination policy required by paragraph (b)(1)
of this section.
(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.
[[Page 37697]]
(2) A covered entity to which this paragraph applies must retain
records related to grievances filed pursuant to the covered entity's
grievance procedures required under paragraph (c)(1) of this section
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 the covered entity resolves 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; the date the grievance was resolved;
grievance resolution; and any other pertinent information.
(3) A covered entity to which this paragraph (c) 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 individuals with limited English
proficiency when required under Sec. 92.201. At a minimum, the
language access procedures must include current contact information for
the section 1557 Coordinator (if applicable); how an employee
identifies whether an individual has limited English proficiency; how
an employee obtains the services of qualified interpreters and
translators the covered entity uses to communicate with an individual
with limited English proficiency; the names of any qualified bilingual
staff members; and a list of any electronic and written translated
materials the covered entity has, the languages they are translated
into, date of issuance, and how to access electronic translations.
(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 the covered entity's 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 current 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 Age Act if section 1557 and
the provisions in this part are clearly addressed therein.
(h) Changes to policies and procedures. (1) Covered entities must
review and revise the policies and procedures required by paragraphs
(b) through (g) of this section, as necessary, to ensure they are
current and in compliance with section 1557 and this part; and
(2) A covered entity may change a policy or procedure required by
paragraphs (b) through (g) of this section at any time, provided that
such changes comply with section 1557 and this part.
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 30 days following a covered
entity's implementation of the policies and procedures required by
Sec. 92.8, and no later than 300 days following July 5, 2024;
(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 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.
(4) For purposes of this section, ``relevant employees'' includes
permanent and temporary employees whose roles and responsibilities
entail interacting with patients and members of the public; making
decisions that directly or indirectly affect patients' health care,
including the covered entity's executive leadership team and legal
counsel; and performing tasks and making decisions that directly or
indirectly affect patients' financial obligations, including billing
and collections.
(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 retain 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 the covered entity's 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 (consistent with the scope of sex discrimination
described at Sec. 92.101(a)(2)), age, or disability;
(ii) The covered entity provides reasonable modifications for
individuals with disabilities, and appropriate
[[Page 37698]]
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 a reasonable step to provide meaningful access to an
individual with limited English proficiency;
(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 (if applicable);
(vi) The availability of the covered entity's grievance procedure
pursuant to Sec. 92.8(c) 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 this paragraph (a)(1).
(2) The notice required under this paragraph (a) 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, in no smaller than
20-point sans serif font, 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) The notice required under paragraph (a) of this section must be
provided in English and at least the 15 languages most commonly spoken
by individuals with limited English proficiency of the relevant State
or States in which a covered entity operates 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, in no smaller than
20-point sans serif font, 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 an individual'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) Communications related to the cost and payment of care with
respect to an individual, including medical billing and collections
materials, and good faith estimates required by section 2799B-6 of the
Public Health Service Act;
(x) Complaint forms; and
(xi) 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:
(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, disability, or any combination thereof, be excluded from
[[Page 37699]]
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:
(i) Sex characteristics, including intersex traits;
(ii) Pregnancy or related conditions;
(iii) Sexual orientation;
(iv) Gender identity; and
(v) Sex stereotypes.
(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 45 CFR parts 80, 84, 86 (subparts C and D), and 91 (subpart B),
respectively. Where this paragraph (b) cross-references regulatory
provisions that use the term ``recipient,'' the term ``recipient or
State Exchange'' shall apply in its place. Where this paragraph (b)
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 45 CFR parts 80, 85, 86 (subparts C and
D), and 91 (subpart B), respectively. Where this paragraph (b) 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 (b) 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 individuals with limited English
proficiency.
(a) General requirement. A covered entity must take reasonable
steps to provide meaningful access to each individual with limited
English proficiency (including companions with limited English
proficiency) 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 individual with limited
English proficiency.
(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 utilize the services of 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 an individual with limited English proficiency, 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 individual with limited English
proficiency; 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 an individual with limited English proficiency to
provide their own interpreter, or to pay the cost of their own
interpreter;
(2) Rely on an adult, not qualified as an interpreter, 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 individual with limited English proficiency immediately
available and the qualified interpreter that arrives confirms or
supplements the initial communications with an initial adult
interpreter; or
(ii) Where the individual with limited English proficiency
specifically requests, in private with a qualified interpreter present
and without an accompanying adult present, 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 public where there is no qualified interpreter for
the individual with limited English proficiency 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
with individuals with limited English proficiency.
(f) Video remote interpreting services. A covered entity that
provides a qualified interpreter for an individual with limited English
proficiency through video remote interpreting services in the covered
entity's health programs and activities must ensure the modality allows
for meaningful access and 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 an individual with limited English
proficiency through audio remote interpreting
[[Page 37700]]
services in the covered entity's health programs and activities must
ensure the modality allows for meaningful access and 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 an individual
with limited English proficiency 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 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 where necessary to afford individuals with disabilities an
equal opportunity to participate in, and enjoy the benefits of, the
health program or activity in question. Such auxiliary aids and
services must be provided free of charge, in accessible formats, in a
timely manner, and in such a way to protect the privacy and the
independence of the individual with a disability.
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 or alteration was commenced
after January 18, 2018. If construction or alteration was begun on or
after July 18, 2016, and on or before January 18, 2018, in conformance
with UFAS, and the facility or part of the facility was not covered by
the 2010 Standards prior to July 18, 2016, then it shall be deemed to
comply with the requirements of this section and with 45 CFR 84.23(a)
and (b). 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 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
or alteration was commenced before July 18, 2016, and such facility
would not have been required to conform with a different accessibility
standard under 28 CFR 35.151.
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).
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 have been
typically or exclusively provided to, or associated with, 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, on the basis of an individual's sex assigned at
birth, gender identity, or gender otherwise recorded, a health care
professional's ability to provide health services if such denial or
limitation has the effect of excluding individuals from participation
in, denying them the benefits of, or otherwise subjecting them
[[Page 37701]]
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 an individual'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. A covered entity's determination must not be based on
unlawful animus or bias, or constitute a pretext for discrimination.
Nothing in this section is intended to preclude a covered entity from
availing itself of protections described in Sec. Sec. 92.3 and 92.302.
(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 coverage 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, disability, or any
combination thereof.
(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-related 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, disability, or any combination thereof;
(2) Have or implement marketing practices or benefit designs that
discriminate on the basis of race, color, national origin, sex, age,
disability, or any combination thereof, 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 assigned 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, including practices that result in the
serious risk of institutionalization or segregation.
(c) Nothing in this section requires coverage of any health service
where the covered entity has a legitimate, nondiscriminatory reason for
denying or limiting coverage of the health service or determining that
such health service fails to meet applicable coverage requirements,
including reasonable medical management techniques such as medical
necessity requirements. Such coverage denial or limitation must not be
based on unlawful animus or bias, or constitute a pretext for
discrimination. Nothing in this section is intended to preclude a
covered entity from availing itself of protections described in
Sec. Sec. 92.3 and 92.302.
(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, as defined in Sec.
92.101(a)(2), 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 or entity
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 or entity has a
relationship or association.
Sec. 92.210 Nondiscrimination in the use of patient care decision
support tools.
(a) General prohibition. A covered entity must not discriminate on
the basis of race, color, national origin, sex, age, or disability in
its health programs or activities through the use of patient care
decision support tools.
(b) Identification of risk. A covered entity has an ongoing duty to
make reasonable efforts to identify uses of patient care decision
support tools in its health programs or activities that employ input
variables or factors that measure race, color, national origin, sex,
age, or disability.
(c) Mitigation of risk. For each patient care decision support tool
identified in paragraph (b) of this section, a covered entity must make
reasonable efforts to mitigate the risk of discrimination resulting
from the tool's use in its health programs or activities.
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
religious freedom and conscience laws.
(a) General application. A recipient may rely on applicable Federal
protections for religious freedom and conscience, and consistent with
Sec. 92.3(c), application of a particular
[[Page 37702]]
provision(s) of this part to specific contexts, procedures, or health
care services shall not be required where such protections apply.
(b) Assurance of religious freedom and conscience exemption. A
recipient that seeks assurance consistent with paragraph (a) of this
section regarding the application of particular provision(s) of this
part to specific contexts, procedures, or health care services may do
so by submitting a notification in writing to the Director of OCR.
Notification may be provided by the recipient at any time, including
before an investigation is initiated or during the pendency of an
investigation. The notification must include:
(1) The particular provision(s) of this part from which the
recipient asserts they are exempt under Federal religious freedom or
conscience protections;
(2) The legal basis supporting the recipient's exemption should
include the standards governing the applicable Federal religious
freedom and conscience protections, such as the provisions in the ACA
itself; the Church, Coats-Snowe, and Weldon Amendments; the generally
applicable requirements of the Religious Freedom Restoration Act
(RFRA); or any other applicable Federal laws; and
(3) The factual basis supporting the recipient's exemption,
including identification of the conflict between the recipient's
religious or conscience beliefs and the requirements of this part,
which may include the specific contexts, procedures, or health care
services that the recipient asserts will violate their religious or
conscience beliefs overall or based on an individual patient matter.
(c) Temporary exemption. A temporary exemption from administrative
investigation and enforcement will take effect upon the recipient's
submission of the notification--regardless of whether the assurance is
sought before or during an investigation. The temporary exemption is
limited to the application of the particular provision(s) in this part
as applied to the specific contexts, procedures, or health care
services identified in the notification to OCR.
(1) If the notification is received before an investigation is
initiated, within 30 days of receiving the notification, OCR must
provide the recipient with email confirmation acknowledging receipt of
the notification. OCR will then work expeditiously to reach a
determination of recipient's notification request.
(2) If the notification is received during the pendency of an
investigation, the temporary exemption will exempt conduct as applied
to the specific contexts, procedures, or health care services
identified in the notification during the pendency of OCR's review and
determination regarding the notification request. The notification
shall further serve as a defense to the relevant investigation or
enforcement activity regarding the recipient until the final
determination of recipient's exemption assurance request or the
conclusion of the investigation.
(d) Effect of determination. If OCR makes a determination to
provide assurance of the recipient's exemption from the application of
certain provision(s) of this part or that modified application of
certain provision(s) is required, OCR will provide the recipient its
determination in writing, and if granted, the recipient will be
considered exempt from OCR's administrative investigation and
enforcement with regard to the application of that provision(s) as
applied to the specific contexts, procedures, or health care services
provided. The 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.
(e) Appeal. A recipient subject to an adverse determination of its
request for an exemption assurance may appeal OCR's determination under
the administrative procedures set forth at 45 CFR part 81. The
temporary exemption provided for in paragraph (c) of this section will
expire upon a final decision under 45 CFR part 81.
(f) Final agency action. A determination under this section is not
final for purposes of judicial review until after a final decision
under 45 CFR part 81.
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 against health programs
and activities of recipients and State Exchanges concerning
discrimination on the basis of race, color, national origin, sex, age,
disability, or any combination thereof, under section 1557 or this
part. These procedures are found at 45 CFR 80.6 through 80.11 and 45
CFR part 81.
(b) If OCR receives a complaint over which it does not have
jurisdiction, it shall promptly notify the complainant and shall make
reasonable efforts to refer the complaint to the appropriate Federal
Government entity.
(c) When a recipient or State Exchange 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 or this part 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) The procedural provisions applicable to section 504 shall apply
with respect to administrative enforcement actions against the
Department, including Federally-facilitated Exchanges, concerning
discrimination on the basis of race, color, national origin, sex, age,
disability, or any combination thereof, under section 1557 or this
part. These procedures are found at 45 CFR 85.61 and 85.62. Where this
section cross-references regulatory provisions that use the term
``handicap,'' the term ``race, color, national origin, sex, age, or
disability, or any combination thereof,'' shall apply in its place.
(b) 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.
(c) 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.
[[Page 37703]]
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, 300gg-
92, and 300gg-111 through 300gg-139, as amended, and section 3203,
Pub. L. 116-136, 134 Stat. 281.
0
17. Amend Sec. 147.104 by revising paragraph (e) to read as follows:
Sec. 147.104 Guaranteed availability of coverage.
* * * * *
(e) Marketing. A health insurance issuer and its officials,
employees, agents and representatives must comply with any applicable
State laws and regulations regarding marketing by health insurance
issuers and cannot employ marketing practices or benefit designs that
will have the effect of discouraging the enrollment of individuals with
significant health needs in health insurance coverage or discriminate
based on an individual's race, color, national origin, present or
predicted disability, age, sex (which includes discrimination on the
basis of sex characteristics, including intersex traits; pregnancy or
related conditions; sexual orientation; gender identity; and sex
stereotypes), expected length of life, degree of medical dependency,
quality of life, or other health conditions.
* * * * *
PART 155--EXCHANGE ESTABLISHMENT STANDARDS AND OTHER RELATED
STANDARDS UNDER THE AFFORDABLE CARE ACT
0
18. The authority citation for part 155 continues to read as follows:
Authority: 42 U.S.C. 18021-18024, 18031-18033, 18041-18042,
18051, 18054, 18071, and 18081-18083.
0
19. Amend Sec. 155.120 by revising paragraph (c)(1)(ii) to read as
follows:
Sec. 155.120 Non-interference with Federal law and non-discrimination
standards.
* * * * *
(c) * * *
(1) * * *
(ii) Not discriminate based on race, color, national origin,
disability, age, or sex (which includes discrimination on the basis of
sex characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes).
* * * * *
0
20. Amend Sec. 155.220 by revising paragraph (j)(2)(i) to read as
follows:
Sec. 155.220 Ability of States to permit agents and brokers and web-
brokers to assist qualified individuals, qualified employers, or
qualified employees enrolling in QHPs.
* * * * *
(j) * * *
(2) * * *
(i) Provide consumers with correct information, without omission of
material fact, regarding the Federally-facilitated Exchanges, QHPs
offered through the Federally-facilitated Exchanges, and insurance
affordability programs, and refrain from marketing or conduct that is
misleading (including by having a direct enrollment website that HHS
determines could mislead a consumer into believing they are visiting
HealthCare.gov), coercive, or discriminates based on race, color,
national origin, disability, age, or sex (which includes discrimination
on the basis of sex characteristics, including intersex traits;
pregnancy or related conditions; sexual orientation; gender identity;
and sex stereotypes);
* * * * *
PART 156--HEALTH INSURANCE ISSUER STANDARDS UNDER THE AFFORDABLE
CARE ACT, INCLUDING STANDARDS RELATED TO EXCHANGES
0
21. The authority citation for part 156 continues to read as follows:
Authority: 42 U.S.C. 18021-18024, 18031-18032, 18041-18042,
18044, 18054, 18061, 18063, 18071, 18082, and 26 U.S.C. 36B.
0
22. Amend Sec. 156.200 by revising paragraph (e) to read as follows:
Sec. 156.200 QHP issuer participation standards.
* * * * *
(e) Non-discrimination. A QHP issuer must not, with respect to its
QHP, discriminate on the basis of race, color, national origin,
disability, age, or sex (which includes discrimination on the basis of
sex characteristics, including intersex traits; pregnancy or related
conditions; sexual orientation; gender identity; and sex stereotypes).
* * * * *
0
23. Amend Sec. 156.1230 by revising paragraph (b)(2) to read as
follows:
Sec. 156.1230 Direct enrollment with the QHP issuer in a manner
considered to be through the Exchange.
* * * * *
(b) * * *
(2) The QHP issuer must provide consumers with correct information,
without omission of material fact, regarding the Federally-facilitated
Exchanges, QHPs offered through the Federally-facilitated Exchanges,
and insurance affordability programs, and refrain from marketing or
conduct that is misleading (including by having a direct enrollment
website that HHS determines could mislead a consumer into believing
they are visiting HealthCare.gov), coercive, or discriminates based on
race, color, national origin, disability, age, or sex (which includes
discrimination on the basis of sex characteristics, including intersex
traits; pregnancy or related conditions; sexual orientation; gender
identity; and sex stereotypes).
[FR Doc. 2024-08711 Filed 4-26-24; 4:15 pm]
BILLING CODE 4153-01-P