Rule2024-08711
Nondiscrimination in Health Programs and Activities
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 6, 2024
Effective
July 5, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
The Department of Health and Human Services (HHS or the Department) is issuing this 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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="/cdn-cgi/l/email-protection#fecfcbcbc9be96968dd0999188"><span class="__cf_email__" data-cfemail="5d6c68686a1d35352e733a322b">[email protected]</span></a>, 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 <a href="/cdn-cgi/l/email-protection#0332363634436b6b702d646c75"><span class="__cf_email__" data-cfemail="f9c8ccccceb991918ad79e968f">[email protected]</span></a>.
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 <a href="https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments">https://www.regulations.gov/docket/HHS-OCR-2013-0007/comments</a>.
\2\ The 2015 NPRM received roughly 2,160 comments, which are
available for public inspection at <a href="https://www.regulations.gov/docket/HHS-OCR-2015-0006/comments">https://www.regulations.gov/docket/HHS-OCR-2015-0006/comments</a>.
\3\ The 2019 NPRM received roughly 198,845 comments, which are
available for public inspection at <a href="https://www.regulations.gov/document/HHS-OCR-2019-0007-0001">https://www.regulations.gov/document/HHS-OCR-2019-0007-0001</a>. 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 <a href="https://www.regulations.gov/docket/HHS-OS-2022-0012">https://www.regulations.gov/docket/HHS-OS-2022-0012</a>.
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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:
------------------------------------------------------------------------
Section 1557 Requirement and Date by which covered entities must
provision comply
------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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), <a href="https://www.hhs.gov/sites/default/files/2015_11_04_fed_civil_rights_section_1557_memo_508.pdf">https://www.hhs.gov/sites/default/files/2015_11_04_fed_civil_rights_section_1557_memo_508.pdf</a>.
---------------------------------------------------------------------------
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, <a href="https://www.ihs.gov/newsroom/factsheets/ihsprofile/">https://www.ihs.gov/newsroom/factsheets/ihsprofile/</a>.
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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\
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\22\ U.S. Dep't of Health & Hum. Servs., Indian Health Servs.,
About IHS, <a href="https://www.ihs.gov/aboutihs/">https://www.ihs.gov/aboutihs/</a>.
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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.'').
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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, <a href="https://taggs.hhs.gov/">https://taggs.hhs.gov/</a>, 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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\35\ See 88 FR 63392, 63465 (Sept. 14, 2023) (proposing to
define ``companion'' consistent with ADA title II regulations).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\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), <a href="https://www.hhs.gov/sites/default/files/csr-payment-memo.pdf">https://www.hhs.gov/sites/default/files/csr-payment-memo.pdf</a>. 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), <a href="https://www.cms.gov/files/document/1332-nj-extension-approval-letter-stcs-final.pdf">https://www.cms.gov/files/document/1332-nj-extension-approval-letter-stcs-final.pdf</a>.
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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., <a href="http://www.markfarrah.com">http://www.markfarrah.com</a> (statistics
compiled using data from the National Association of Insurance
Commissioners, the California Department of Managed Health Care, and
CMS).
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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.''
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\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?, <a href="https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-what-is-it.html">https://www.hopkinsmedicine.org/research/understanding-clinical-trials/clinical-research-what-is-it.html</a>.
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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'').
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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).
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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.).
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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.
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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.
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\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), <a href="https://oversight.house.gov/wp-content/uploads/2021/12/PBM-Report-12102021.pdf">https://oversight.house.gov/wp-content/uploads/2021/12/PBM-Report-12102021.pdf</a>.
\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),
<a href="https://www.gao.gov/assets/gao-19-498.pdf">https://www.gao.gov/assets/gao-19-498.pdf</a>; Visante, Pharmacy Benefit
Managers (PBMs): Generating Savings for Plan Sponsors and Consumers,
pp. 3-4 (2023), <a href="https://www.pcmanet.org/wp-content/uploads/2023/01/Pharmacy-Benefit-Managers-PBMs-Generating-Savings-for-Plan-Sponsors-and-Consumers-January-2023.pdf">https://www.pcmanet.org/wp-content/uploads/2023/01/Pharmacy-Benefit-Managers-PBMs-Generating-Savings-for-Plan-Sponsors-and-Consumers-January-2023.pdf</a>.
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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,
<a href="https://www.eeoc.gov/laws/guidance/eeoc-enforcement-guidance-national-origin-discrimination#_Toc451518799">https://www.eeoc.gov/laws/guidance/eeoc-enforcement-guidance-national-origin-discrimination#_Toc451518799</a>.
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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, <a href="https://www.justice.gov/crt/fcs/EmergenciesGuidance">https://www.justice.gov/crt/fcs/EmergenciesGuidance</a>.
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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), <a href="https://www.propublica.org/article/cigna-pxdx-medical-health-insurance-rejection-claims">https://www.propublica.org/article/cigna-pxdx-medical-health-insurance-rejection-claims</a>; 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), <a href="https://www.statnews.com/2023/03/13/medicare-advantage-plans-denial-artificial-intelligence/">https://www.statnews.com/2023/03/13/medicare-advantage-plans-denial-artificial-intelligence/</a>.
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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 ``betw
[…truncated; see source link]Indexed from Federal Register on May 6, 2024.
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