Rule2024-09237
Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance
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 9, 2024
Effective
July 8, 2024
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services (HHS or the Department) is committed to protecting the civil rights of individuals with disabilities under section 504 of the Rehabilitation Act of 1973 (section 504). To implement the prohibition of discrimination on the basis of disability, the Department is making a number of revisions to update and amend its section 504 regulation.
Full Text
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<title>Federal Register, Volume 89 Issue 91 (Thursday, May 9, 2024)</title>
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<body><pre>
[Federal Register Volume 89, Number 91 (Thursday, May 9, 2024)]
[Rules and Regulations]
[Pages 40066-40195]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09237]
[[Page 40065]]
Vol. 89
Thursday,
No. 91
May 9, 2024
Part IV
Department of Health and Human Services
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45 CFR Part 84
Nondiscrimination on the Basis of Disability in Programs or Activities
Receiving Federal Financial Assistance; Final Rule
Federal Register / Vol. 89 , No. 91 / Thursday, May 9, 2024 / Rules
and Regulations
[[Page 40066]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 84
RIN 0945-AA15
Nondiscrimination on the Basis of Disability in Programs or
Activities Receiving Federal Financial Assistance
AGENCY: U.S. Department of Health and Human Services.
ACTION: Final rule.
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SUMMARY: The Department of Health and Human Services (HHS or the
Department) is committed to protecting the civil rights of individuals
with disabilities under section 504 of the Rehabilitation Act of 1973
(section 504). To implement the prohibition of discrimination on the
basis of disability, the Department is making a number of revisions to
update and amend its section 504 regulation.
DATES:
Effective date: This rule is effective July 8, 2024.
Incorporation by reference: The incorporation by reference of
certain material listed in the rule is approved by the Director of the
Federal Register as of July 8, 2024.
FOR FURTHER INFORMATION CONTACT: Molly Burgdorf, Office for Civil
Rights, Department of Health and Human Services at (202) 545-4884 or
(800) 537-7697 (TDD), or via email at <a href="/cdn-cgi/l/email-protection#be8b8e8afed6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="5d686d691d35352e733a322b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Overview of the Final Rule
III. Response to Public Comments on the Proposed Rule
IV. Executive Order 12866 and Related Executive Orders on Regulatory
Review
I. Background
Section 504 of the Rehabilitation Act of 1973 prohibits
discrimination on the basis of disability in programs and activities
that receive Federal financial assistance as well as in programs and
activities conducted by any Federal agency.\1\
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\1\ 29 U.S.C. 794.
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The Office for Civil Rights (OCR) in HHS enforces section 504 as
well as other statutes that prohibit discrimination on the basis of
disability. Title II of the Americans with Disabilities Act (ADA)
prohibits discrimination on the basis of disability in, among other
areas, all health care and social services programs and activities of
State and local government entities.\2\ OCR also enforces section 1557
(section 1557) of the Patient Protection and Affordable Care Act (ACA)
which prohibits discrimination on various bases, including disability,
in any health program or activity, any part of which receives Federal
financial assistance, including credits, subsidies, or contracts of
insurance or under any program or activity that is administered by an
Executive Agency or any entity established under title I of the ACA.\3\
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\2\ 42 U.S.C. 12132.
\3\ 42 U.S.C. 18116.
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Congress passed the Rehabilitation Act in 1973, and what was then
the U.S. Department of Health, Education, and Welfare issued
regulations to implement section 504 in 1977. Those regulations have
rarely been amended.\4\ In the more than 40 years since enactment of
the regulations, major legislative and judicial developments have
shifted the legal landscape of disability discrimination protections
under section 504. These developments include multiple statutory
amendments to the Rehabilitation Act, the enactment of the ADA and ADA
Amendments Act of 2008 (ADAAA), passage of the ACA, and Supreme Court
and other significant court cases. In addition, the Department is aware
of specific manifestations of disability-based discrimination in recent
years, for example, in the area of accessibility of information and
communications technology.
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\4\ Amendments to the section 504 regulations over time have
included changes such as addressing the withholding of medical care
from infants with disabilities (changes that the Supreme Court
invalidated in Bowen v. Amer. Hosp. Ass'n, 476 U.S. 610 (1986));
changes to the accessible building standards; and changes to the
definition of ``program or activity'' to conform to the Civil Rights
Restoration Act of 1987).
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Section 504 must be interpreted consistently with these
developments and laws to ensure conformity with current law and to
protect against discrimination on the basis of disability. To provide
clarity for recipients and beneficiaries and to promote compliance, the
Department is amending its existing section 504 regulation on
nondiscrimination obligations for recipients of Federal financial
assistance (part 84).\5\
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\5\ The Department notes that on January 15, 2021, OCR posted on
its website a Request for Information (RFI) addressing a number of
disability discrimination issues under part 84 of section 504. The
RFI was later withdrawn, without being published in the Federal
Register. OCR subsequently received letters urging HHS to address
the issues in the RFI.
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II. Overview of the Final Rule
On September 14, 2023, the Department published a proposed rule to
amend 45 CFR part 84, Discrimination on the Basis of Disability in
Programs or Activities Receiving Federal Financial Assistance (88 FR
63392). The 60-day comment period ended on November 13, 2023. The final
rule adopts the same structure and subparts as the proposed rule. We
have made some changes to the proposed rule's provisions based on
comments received. As discussed in the notice of proposed rulemaking
(NPRM), to fulfill Congress's intent that title II of the ADA and
section 504 be interpreted consistently, the rule contains provisions
that mirror the corresponding provisions in the title II ADA
regulation.
No substantive difference is intended, aside from denoting the
singular or plural, when using the terms ``individual with a
disability,'' ``people with disabilities,'' and ``person with a
disability'' throughout this rule.
The Department is retaining several sections from the existing
section 504 rule. Many of those retained sections contain terminology
revisions. The current rule can be found at: <a href="https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-84">https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-84</a>.
III. Response to Public Comments on the Proposed Rule
This section focuses on the provisions of the rule that are
relevant to comments received, and the explanations necessary to
address those comments. For a fuller explanation of the background and
intended meaning of regulatory language in the final rule that remain
unchanged from the NPRM, please refer to the discussion in the NPRM.
Subpart A--General Provisions
Subpart A sets forth the general provisions that apply to all
recipients. Four of the sections from the existing regulation are
retained without any changes, Sec. Sec. 84.5 through 84.7 and 84.9.
The remainder of the sections in this subpart are identical or similar
to the ADA title II regulations.
Purpose and Broad Coverage (Sec. 84.1)
Proposed Sec. 84.1(a) provided that the purpose of this regulation
is to implement section 504, which prohibits discrimination on the
basis of disability in any program or activity receiving Federal
financial assistance.
Proposed Sec. 84.1(b) stated that the definition of ``disability''
shall be construed broadly in favor of expansive coverage to the
maximum extent
[[Page 40067]]
permitted by section 504. The primary objective of attention in cases
should be whether recipients have complied with their obligations and
whether discrimination occurred, and not whether the individual meets
the definition of ``disability.'' The question of whether an individual
meets the definition of ``disability'' should not demand extensive
analysis.
The comments and our responses regarding Sec. 84.1 are set forth
below.
Comment: The Department received many comments applauding the
inclusion of this section. Commenters expressed appreciation for the
Department's commitment to construing the protection of the law broadly
in favor of expansive coverage.
Response: The Department appreciates the commenters' input.
Summary of Regulatory Changes
We are finalizing Sec. 84.1 as proposed with no modifications.
Application (Sec. 84.2)
Proposed Sec. 84.2(a) provided that this part applies to each
recipient of Federal financial assistance from the Department and to
the recipient's programs and activities that involve individuals with
disabilities in the United States. This part does not apply to the
recipient's programs and activities outside the United States that do
not involve individuals with disabilities in the United States.
Proposed Sec. 84.2(b) provided that the requirements of this part
do not apply to the ultimate beneficiaries of any program or activity
operated by a recipient of Federal financial assistance.
Proposed Sec. 84.2(c) provided that any provision of this part
held to be invalid or unenforceable by its terms, or as applied to any
person or circumstance, shall be construed so as to continue to give
maximum effect to the provision permitted by law, unless such holding
shall be one of utter invalidity or unenforceability, in which event
the provision shall be severable from this part and shall not affect
the remainder thereof or the application of this provision to other
persons not similarly situated or to other dissimilar circumstances.
The comments and our responses regarding proposed Sec. 84.2 are
set forth below.
Comments: The Department received several comments asking for
clarification of the types of entities covered by section 504. Many
mentioned specific entities and asked whether they are covered. Others
requested that the Department provide a list of all covered entities.
Response: Most of these commenters were essentially asking for a
more detailed explanation of what constitutes ``Federal financial
assistance,'' the prerequisite to section 504 coverage, than what
appeared in the proposed rule's definition. The Department's
interpretation of Federal financial assistance and the types of
entities covered by this rule can be found in the discussion of Federal
financial assistance contained at Sec. 84.10, the definitions section
of the rule.
Summary of Regulatory Changes
For the reasons set forth above and considering comments received,
we are finalizing Sec. 84.2 as proposed with no modifications.
Relationship to Other Laws (Sec. 84.3)
Proposed Sec. 84.3 provided an explanation of the relationship of
the proposed regulation to existing laws. The section provided that
this part does not invalidate or limit remedies, rights, and procedures
of any other Federal law, State, or local law that provides greater or
equal protection for the rights of individuals with disabilities and
individuals associated with them.
The comments and our responses to Sec. 84.3 are set forth below.
Comments: The Department received many comments, including from
multiple disability rights organizations, concerning the relationship
of this regulation to other laws. Several commenters mentioned the
importance of ensuring that laws providing more protection such as the
ADA are not affected by this regulation. One commenter remarked that
the principle encompassed in this section is fundamental to maintaining
a comprehensive support system for individuals with disabilities as it
recognizes that laws are layered and work together. Another commenter
urged the Department to adopt this section to ensure that any new
Federal requirements offer a floor, but not a ceiling, for the
protection of disability rights. Many organizations representing
individuals with disabilities asked the Department to clarify how this
regulation interacts with section 1557.
Another commenter asked about the relationship of section 504 to
State laws and whether Federal law always supersedes State law.
Response: The Department appreciates commenters' support for this
provision. In developing this regulation, we have been closely
coordinating within the Department on the section 1557 rule, and we
will continue this close coordination on the impact of the 504 rule and
its relationship to other applicable laws, including section 1557, in
the future. We will consider developing guidance and technical
assistance as needed on these topics in the future.
As for whether Federal laws always supersede State laws, we note
that standard principles of preemption apply under section 504.
Summary of Regulatory Changes
For the above reasons and considering comments received, we are
finalizing Sec. 84.3 as proposed with no modifications.
Disability (Sec. 84.4)
Proposed Sec. 84.4 provided a detailed definition of disability
implementing the ADAAA, which amended section 504 to adopt the ADAAA
definition of disability. The proposed rule largely incorporated the
definition contained in the ADA title II regulation and was intended to
ensure consistency between the ADA and section 504. The only
differences between the definition of disability in Sec. 84.4 and the
definition of disability in the ADA title II regulation were updates in
terminology and the addition of long COVID, a condition that did not
exist when the ADA regulation was published, to the list of physical
and mental impairments.
Proposed Sec. 84.4(a)(1) stated that, with respect to an
individual, disability means a physical or mental impairment that
substantially limits one or more of the major life activities of such
individual; a record of such an impairment; or being regarded as having
such an impairment. Proposed Sec. 84.4(a)(2) stated that the
definition of disability shall be construed broadly in favor of
expansive coverage to the maximum extent permitted by the terms of
section 504.
Proposed Sec. 84.4 provided detailed definitions of the terms used
in Sec. 84.4(a)(1). It defined physical or mental impairment (Sec.
84.4(b)), major life activities (Sec. 84.4(c)), substantially limits
(Sec. 84.4(d)), has a record of such an impairment (Sec. 84.4(e)), is
regarded as having such an impairment (Sec. 84.4(f)), and it included
a list of conditions excluded from the definition (Sec. 84.4(g)). At
Sec. 84.4(d)(2), it provided a list of predictable assessments,
circumstances where the inherent natures of the specific impairments
will, as a factual matter, virtually always be found to impose a
substantial limitation on a major life activity, and for which the
necessary individualized assessment should be particularly simple and
straightforward (e.g., deafness substantially limits hearing).
[[Page 40068]]
At proposed Sec. 84.4(b)(2), the rule included long COVID as a
physical or mental impairment. This inclusion follows guidance issued
on July 26, 2021, from the Department of Justice (DOJ) and HHS on how
long COVID can be a disability under the ADA, section 504, and section
1557.\6\
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\6\ See U.S. Dep't of Health & Human Servs., U.S. Dep't of
Justice, Guidance on ``Long COVID'' as a Disability Under the ADA,
section 504, and section 1557 (July 26, 2021), <a href="https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/guidance-long-covid-disability/index.html">https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/guidance-long-covid-disability/index.html</a>.
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When the Department proposed section 84.4(g), it addressed
exclusions from section 504 coverage by taking language directly from
the text of the Rehabilitation Act.\7\ Section 84.4(g) now states that
the term ``disability'' does not include the terms set forth at 29
U.S.C. 705(20)(F). That statutory text excludes gender identity
disorders not resulting from physical impairments from the definition
of disability. The Department noted in the preamble of the proposed
rule that an individual with gender dysphoria may have a disability
under section 504 and that restrictions that prevent, limit, or
interfere with otherwise qualified individuals' access to care due to
their gender dysphoria, gender dysphoria diagnosis, or perception of
gender dysphoria, may violate section 504.
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\7\ 29 U.S.C. 705(20)(F).
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The comments and our responses to Sec. 84.4 are set forth below.
Comments: Commenters expressed strong support for the Department's
revised definition of disability, for complying with the ADAAA, and for
ensuring consistency with the Department of Justice's ADA regulatory
definition of disability. Commenters also expressed approval for the
specific inclusion of long COVID as a physical or mental impairment.
Response: Accordingly, the Department has retained the approach and
language of its proposed rule in this final rule and has retained the
inclusion of long COVID as a physical or mental impairment.
Physical and Mental Impairments (Sec. 84.4(b))
Comments: Although expressing support for the Department's
expansion of its definition of disability, a number of commenters
suggested adding specific conditions to the text of Sec. 84.4(b).
These commenters suggested specifically including in the regulatory
text a number of conditions as impairments, including, for example:
obesity, hepatitis B, hepatitis C, endometriosis, developmental
disabilities, intersex variations, and chemical and electromagnetic
hypersensitivities (including allergies to fragrances). One commenter
noted that ``autism'' was not included in the list of impairments, but
that Autism Spectrum Disorder was included in Sec. 84.4(d)(2)(iii)(E).
The comments included descriptions of the discrimination faced by
persons with these conditions and how inclusion in the Department's
section 504 regulation would provide a vehicle for their active
participation in programs and activities funded by the Department.
Response: The Department notes that the list of disorders and
conditions in Sec. 84.4(b) is non-exhaustive and illustrative. The
preamble to the DOJ's title II ADA regulation explains why there was no
attempt to set forth a comprehensive list of physical and mental
impairments. That preamble states ``[i]t is not possible to include a
list of all the specific conditions, contagious and noncontagious
diseases, or infections that would constitute physical or mental
impairments because of the difficulty of ensuring the comprehensiveness
of such a list, particularly in light of the fact that other conditions
or disorders may be identified in the future.'' \8\ The Department
shares this view. Failure to include any specific disorder or condition
does not mean that that condition is not a physical or mental
impairment under section 504 or the rule. No negative implications
should be drawn from the omission of any specific impairment in the
list of impairments in Sec. 84.4(b). In fact, the Department notes
that its rule of construction for the definition of disability is that
the definition of disability is to be construed broadly in favor of
expansive coverage to the maximum extent permitted by the terms of
section 504.
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\8\ 28 CFR part 35, appendix B.
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As a result, the Department has decided not to add any further
specific disorders or conditions to the regulatory text of Sec.
84.4(b). This approach has the added benefit of ensuring a consistent
interpretation of this important statutory term that is shared by both
section 504 and both titles II and III of the ADA and avoids any
confusion that might result from having related Federal disability
rights regulations with different language for the same term.
The Department wishes to make clear, however, that the conditions
proffered by commenters may constitute a physical or mental impairment
as that term is used in section 504. For example, obesity, without any
accompanying comorbidities, may be included in the phrase ``any
physiological disorder or condition'' and thus constitute a physical
impairment for higher-weight individuals. Similarly, intersex
variations may result from physical conditions that are structured or
function differently from most of the population and affect the
endocrine, reproductive, and/or genitourinary systems of an individual,
or may be evidenced by anatomical loss affecting one or more of the
body's systems, and thus be included within the phrase ``any
physiological disorder or condition.'' The Department received comments
asking that we add other, specific conditions to the list of physical
and mental impairments. While many conditions may constitute a physical
or mental impairment as that term is used in section 504, it is not
necessary for the Department to add these conditions to the rule as the
Department's list is not an exhaustive list.
Of course, being included as a physical or mental impairment does
not mean that a particular individual has a disability covered by
section 504. To be covered by section 504 and Department's final rule,
the impairment must then substantially limit one or more of the
person's major life activities. In addition, section 504 coverage could
be established for a particular individual if that person has a record
of the impairment that substantially limited one of more of their major
life activities; or if they were subjected to a prohibited action
because of an actual or perceived physical or mental impairment,
whether or not that impairment substantially limits, or is perceived to
substantially limit, a major life activity.
Gender Dysphoria
Comments: The preamble of the Department's NPRM included in its
analysis of Sec. 84.4(g), Exclusions, a discussion of section 504's
exclusion of gender identity disorders not resulting from physical
impairments, and a recent Fourth Circuit case, Williams v. Kincaid,\9\
concluding that gender dysphoria can be a disability under section 504
and the ADA. In the NPRM, the Department agreed with the Fourth
Circuit's recent holding that gender dysphoria may constitute a
disability under section 504 and that restrictions that prevent, limit,
or interfere with otherwise qualified individuals' access to care due
to their gender dysphoria, gender dysphoria diagnosis, or
[[Page 40069]]
perception of gender dysphoria may violate section 504.
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\9\ Williams v. Kincaid, 45 F.4th 759 (4th Cir. 2022, cert.
denied, 600 U.S. __ (June 30, 2023) (No. 22-633).
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The inclusion of this discussion in the preamble elicited a robust
discussion from commenters. Comments from civil rights and patient
advocacy organizations representing persons with disabilities supported
the concept of coverage of gender dysphoria in the section 504 rule but
sought changes that would strengthen the Department's inclusion of
gender dysphoria by including specific regulatory text (e.g., by making
clear that gender dysphoria is not included within the scope of gender
identity disorders) and by expanding and clarifying protections.
Commenters representing certain religious organizations and some
State officials, among others, objected to the Department's conclusion
that gender dysphoria can be a disability covered under section 504.
The comments asserted that the Kincaid decision is only one court
decision, that the dissent in the case was more compelling, and that
the Department has ignored contrary court decisions.\10\ These
commenters stated that the Department's view could adversely impact
them because section 504 does not have an exemption for religious
entities. In the alternative, the commenters sought significantly more
detail regarding what actions will be prohibited or required by
inclusion of the language.
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\10\ See, e.g., Duncan v. Jack Henry & Assocs., Inc., 617 F.
Supp. 3d 1011, 1055-57 (W.D. Mo. 2022); Lange v. Houston Cnty., 608
F. Supp. 3d 1340, 1362 (M.D. Ga. 2022); Doe v. Northrop Grumman Sys.
Corp., 418 F. Supp. 3d 921 (N.D. Ala. 2019); Parker v. Strawser
Constr. Inc., 307 F. Supp. 3d 744, 754-55 (S.D. Ohio 2018); Gulley-
Fernandez v. Wis. Dep't of Corr., 2015 WL 7777997, at *3 (E.D. Wis.
Dec. 1, 2015); but see Doe v. Mass. Dep't of Corr., 2018 WL 2994403
(D. Mass. Jun. 14, 2018); Blatt v. Cabela's Retail, Inc., 2017 WL
2178123 (E.D. Pa. May 18, 2017); Guthrie v. Noel, 2023 WL 8115928,
at *13 (M.D. Pa. Sept. 11, 2023).
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Response: As noted above, the Department's section 504 NPRM
preamble noted that gender dysphoria may constitute a disability under
section 504 and that restrictions that prevent, limit, or interfere
with otherwise qualified individuals' access to care due to their
gender dysphoria, gender dysphoria diagnosis, or perception of gender
dysphoria may violate section 504.
In the Williams case, the only Federal appellate court to consider
the issue of coverage for gender dysphoria under section 504 and the
ADA concluded that the language excluding gender identity disorders
from coverage did not encompass gender dysphoria. The Fourth Circuit
reversed and remanded the district court's dismissal of the case,
holding that the plaintiff ``has plausibly alleged that gender
dysphoria does not fall within section 504's and the ADA's exclusion
for ``gender identity disorders not resulting from physical
impairments.'' \11\ The court noted that the term ``gender dysphoria''
was not used in section 504 or the ADA nor in the then current version
of the Diagnostic and Statistical Manual of Mental Disorders (DSM). In
2013, the phrase was changed in the DSM from ``gender identity
disorder'' to ``gender dysphoria,'' a revision that the court said was
not just semantic but reflected a shift in medical understanding. The
court reasoned that gender dysphoria is not included in the scope of
the exclusion for ``gender identity disorders,'' but that even if
gender dysphoria were such a disorder, plaintiff's complaint ``amply
supports [the] inference'' that her gender dysphoria ``result[s] from a
physical impairment.'' \12\
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\11\ Id. at 780.
\12\ Id. at 773-74 (citing 42 U.S.C. 12211(b)); see also id. at
770-72.
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Recognizing ``Congress' express instruction that courts construe
the ADA in favor of maximum protection for those with disabilities,''
\13\ the court said that it saw ``no legitimate reason why Congress
would intend to exclude from the ADA's protections transgender people
who suffer from gender dysphoria.'' \14\ The Department agrees with the
court's holding that restrictions that prevent, limit, or interfere
with otherwise qualified individuals' access to care due to their
gender dysphoria, gender dysphoria diagnosis, or perception of gender
dysphoria may violate section 504.\15\
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\13\ Id. at 769-70.
\14\ Id. at 773.
\15\ The Department's interpretation is also consistent with the
position taken by the Department of Justice's Civil Rights Division
on the proper interpretation of ``gender identity disorders'' under
the ADA and section 504. See Statement of Interest, Doe v. Ga. Dep't
of Corr., No. 23-5578 (N.D. Ga. Jan. 8, 2024), ECF No. 69.
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The Department will approach gender dysphoria as it would any other
disorder or condition. If a disorder or condition affects one or more
body systems, or is a mental or psychological disorder, it may be
considered a physical or mental impairment. The existing section 504
rule includes the following as body systems: ``neurological,
musculoskeletal, special sense organs, respiratory (including speech
organs), cardiovascular, reproductive, digestive, genitourinary,
immune, circulatory, hemic, lymphatic, skin, and endocrine.'' The issue
before the Department then is whether gender dysphoria is a condition
that can affect any bodily system or is a mental or psychological
condition. Such an inquiry is necessarily a fact-based, individualized
determination but the Department agrees with the Fourth Circuit that
gender dysphoria can satisfy this standard. A determination in an
individual situation that gender dysphoria is a physical or mental
impairment is, of course, not the end of the question. It must then be
determined whether the impairment substantially limits any major life
activity. Depending on that analysis, gender dysphoria may rise to the
level of a disability under section 504 and would provide protection
against discrimination in programs or activities funded by HHS that is
prohibited by section 504.
As to the lower court cases that held that gender dysphoria is
included within the definition of gender identity disorders, the
Department believes that the conclusion the Fourth Circuit reached in
the Williams case and the view expressed in the United States'
Statement of Interest in Doe v. Georgia Department of Corrections
reflect the more compelling reading of the statute. That interpretation
is that, when Congress enacted the ADA in 1990, ``gender identity
disorders'' referred to a person's mere identification with a different
gender than the sex they were assigned at birth, a condition that is
not a disability. Gender dysphoria, by contrast, may be a disability,
one that is characterized by clinically significant distress or
impairment in social, occupational, or other important areas of
functioning; thus gender dysphoria does not fall with the statutory
exclusions for gender identity disorders.\16\
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\16\ See also Am. Psychiatric Ass'n, Diagnostic and Statistical
Manual of Mental Disorders (5th ed. text rev. 2022), <a href="https://perma.cc/U4KQ-HA98">https://perma.cc/U4KQ-HA98</a>.
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As to concerns about religious freedom and conscience, the section
504 rule does not contain provisions on those issues. However, the
Department does have other statutes and regulations that apply
protections in these areas. For example, in January 2024, the
Department finalized a rule clarifying the Department's enforcement of
the Federal health care conscience statutes, including that OCR
receives and handles complaints regarding these statutes.\17\ The
Department will comply with all applicable law. We decline to make
changes to this rule.
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\17\ 89 FR 2078 (Jan. 11, 2024).
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Major Life Activities (Sec. 84.4(c))
Comments: In the Department's NPRM, proposed Sec. 84.4(c)
significantly expanded the range of major life
[[Page 40070]]
activities in the current rule in response to the ADAAA and DOJ's ADA
rules, specifically including major bodily functions and providing an
expanded non-exhaustive list of examples of major life activities. It
also indicated that ``major'' should be interpreted in a more expansive
fashion than previously. Commenters supported the Department's approach
to defining and interpreting the term ``major life activities,'' but
suggested that the Department should add to the list. One commenter
suggested that the major life activity of ``caring for oneself'' was
too narrow in scope and that should be expanded to address caring for
other family members, taking care of pets or service animals, and
caring for guests or visitors to the home, noting that caring for
others, no matter what the relationship, is a common major life
activity. Another commenter suggested including recognition of mental
health and cognitive abilities in this section.
Response: The Department appreciates these comments but has
determined it is not necessary to add these or any other new terms to
the list of major life activities in Sec. 84.4(c). This list is, by
its own terms, not exhaustive and thus other activities can certainly
be considered major life activities. The Department also wants to avoid
any confusion that may be caused by including terms in this regulatory
language that are different than those found in the parallel sections
defining disability under the ADA and titles II and III of the ADA
regulations of DOJ and under title I of the ADA and the regulations of
the Equal Employment Opportunity Commission (EEOC).
As for the coverage of mental health issues, the Department notes
the inclusion of learning, concentrating, and thinking as major life
activities in Sec. 84.4(c)(1)(i) and the operation of neurological
systems as a major bodily function in Sec. 84.4(c)(1)(ii). Further,
because mental health and cognitive capability are central to
functioning and well-being, impairment in either may significantly
impact major life activities such as working, sleeping, and caring for
oneself or others.
Predictable Assessments
Comments: Commenters noted that the list of examples in Sec.
84.4(d)(2)(iii), when referring to the Human Immunodeficiency Virus
(HIV) infection, did not include the phrase ``whether symptomatic or
asymptomatic'' even though that phrase was included in the list of
physical or mental impairments in Sec. 84.4(b)(2) and requested that
the phrase be added in the final rule.
Response: The Department agrees with the commenters that persons
who have HIV are substantially limited in their immune function,
whether or not they present with symptoms of the disease. Section
84.4(d)(2)(iii)(J) of this rule includes HIV, and the provision of
predictable assessments presumptively covers persons who have HIV,
whether or not they are symptomatic. The Department also recognizes the
need to have its regulatory provision here be consistent with the ADA's
parallel regulation on the definition of disability, which does not
include the phrase ``whether symptomatic or asymptomatic'' in the
provision on predictable assessments. As a result, the Department will
not add this phrase to the paragraph on predictable assessments to
avoid any confusion that may result from having Federal regulations
with different terminology on the same issue.
Outdated and Offensive Terminology
Comments: Commenters were uniformly supportive of changing the
terminology in the Department's existing section 504 rule from the use
of ``handicap'' and ``handicapped individual'' to ``disability'' and
``individual with a disability.'' One comment noted that this change
from ``handicap'' to ``disability'' was more than just terminology and
that it reflected issues overlaid with stereotypes, patronizing
attitudes, and other emotional connotations. Commenters were also
uniformly supportive of changing the terminology in the list of
physical and mental impairments in Sec. 84.4(b)(2), and throughout the
rule, from ``drug user'' to ``individual with a substance use
disorder'' and ``alcoholic'' to ``individual with an alcohol use
disorder.'' Some commenters, however, objected to use of the phrase
``emotional or mental illness'' because it carries significant stigma,
and suggested the use of more neutral terminology, such as ``person
with a mental health condition.'' Other commenters objected to the
terminology used in Sec. 84.4(g) on exclusions from coverage and
suggested that the section be removed in its entirety.
Response: The Department is aware that some of the terms used in
its regulation have come to be understood, in common parlance, as
having negative connotations or being pejorative.
The terms that the Department proposed in the regulatory provision
on exclusions, Sec. 84.4(g), are taken verbatim from the
Rehabilitation Act at 29 U.S.C. 705(20)(F). Those terms had specific
meanings when Congress added them to the statute decades ago and the
Department is bound by these statutory exclusions. However, the
Department appreciates that the terminology used in this section of the
statute is now considered offensive to many communities. As such, we
are revising the final section at Sec. 84.4(g) to cite to the relevant
statutory text. This is a non-substantive change; the Department is
still bound by the statutory exclusions cited at Sec. 84.4(g).
With regard to the use of the terms ``emotional or mental illness''
in Sec. 84.4(b)(1)(ii) and ``emotional illness'' in Sec. 84.4(b)(2),
the Department is substituting the neutral term ``mental health
condition.'' Both the terms ``emotional or mental illness'' and
``emotional illness'' are used in the definition of impairments
contained in the definition of ``disability'' in Sec. 84.4(b). These
terms are found in the ADA titles II and III regulations as well as in
the EEOC regulations for title I of the ADA. Because these terms are
regulatory, not statutory, the Department believes it appropriate in
these circumstances to change the language to address usage concerns.
The term ``mental health condition'' is neutral terminology that may
help to reduce the negative connotations for people experiencing mental
health conditions. The Department itself now uses the phrase ``mental
health condition'' instead of emotional or mental illness in other
contexts. The Department intends no difference in meaning with this new
term and it will be interpreted consistently with the terms ``emotional
or mental illness'' or ``emotional illness'' in the parallel ADA titles
II and III regulations.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing Sec. 84.4 as proposed with three
modifications. First, we are replacing the phrase ``emotional or mental
illness'' with ``mental health condition'' in Sec. 84.4(b)(1)(ii).
Second, we are replacing the phrase ``emotional illness'' with ``mental
health condition'' in Sec. 84.4(b)(2). Third, we are replacing a list
of terms at Sec. 84.4(g) with a citation to the relevant passage of
the statute that enumerates exclusions.
Notice (Sec. 84.8)
Proposed Sec. 84.8 required recipients to make available to
employees, applicants, participants, beneficiaries, and other
interested persons information about this part and its applicability to
the recipient's programs and activities, and to make the information
available to them in such
[[Page 40071]]
manner as the head of the agency or their designee finds necessary to
apprise such persons of the protections against discrimination assured
them by section 504 and this part.
The comments and our responses regarding Sec. 84.8 are set forth
below.
Comment: A commenter asked whether a statement on a website about
both the ADA and section 504 is enough and whether this notice
requirement is different from the current requirements. Another
commenter asked whether recipients are required to prominently post the
notice and provide information about filing a complaint.
Response: This notice requirement is identical to the notice
requirement in the ADA title II regulations. Recipients are required to
disseminate sufficient information to applicants, participants,
beneficiaries, and other interested persons to inform them of the
rights and protections afforded by section 504 and this regulation.
Methods of providing this information include, for example, the
publication of information in handbooks, manuals, and pamphlets that
are distributed to the public, including online material, to describe a
recipient's programs and activities; the display of informative posters
in service centers or other public places; or the broadcast of
information by television or radio. In providing the notice, the
recipient must comply with the requirements for effective communication
in Sec. 84.77. The preamble to that section, along with the preamble
from the NPRM, gives guidance on how to effectively communicate with
individuals with disabilities.
In response to the question of whether the existing notice
requirements in Sec. 84.8 are different than those in this final rule,
the biggest difference is that the existing regulations only apply to
recipients with fifteen or more employees. In addition, the existing
notice provisions provide more detailed requirements than are contained
in this final rule. For example, the existing notice section requires
an identification of the responsible employee designated pursuant to
Sec. 84.7(a). It also sets forth requirements for when the notice must
be published, methods of publishing, and the types of documents that
must contain the notice requirement.
There is another notice provision at Sec. 84.52(b) in subpart F,
Health, Welfare, and Social Services, which we are retaining. That
section states that a recipient that provides notice concerning
benefits or services or written material concerning waivers of rights
or consent to treatment shall take such steps as are necessary to
ensure that qualified individuals with disabilities, including those
with impaired sensory or speaking skills, are not denied effective
notice because of their disability.
Section 84.7, Designation of responsible employee and adoption of
grievance procedures, is retained in the final rule. Section 84.7(a)
requires that recipients with fifteen or more employees designate at
least one person to coordinate their efforts to comply with this part.
Section 84.7(b) requires those recipients to adopt grievance procedures
that incorporate due process standards and that provide for the prompt
and equitable resolution of complaints. Although not required, we
recommend that notices contain information about the coordinator and
about the grievance procedures.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing Sec. 84.8 as proposed with no
modifications.
Definitions (Sec. 84.10)
In Sec. 84.10 of the proposed rule, we set out proposed
definitions of various terms. The comments and our responses are set
forth below. Unless otherwise indicated, the definitions are retained
as proposed.
Auxiliary Aids and Services
Discussion of this term can be found at Sec. 84.77.
Archived Web Content
The proposed rule defined ``archived web content'' as ``web content
that is maintained exclusively for reference, research, or
recordkeeping, is not altered or updated after the date of archiving,
and is organized and stored in a dedicated area or areas clearly
identified as being archived.''
Comment: Some commenters requested clarity on the definition of
archived web content. Some of these commenters stated that the word
``maintain'' could have multiple meanings, such as simply continuing
possession or engaging in repair and upkeep.
Response: The Department added a new part to the definition to help
clarify the scope of content covered by the definition and associated
exception. The new part of the definition, the first part, specifies
that archived web content is limited to three types of historic
content: web content that was created before the date the recipient is
required to comply with subpart I; web content that reproduces paper
documents created before the date the recipient is required to comply
with subpart I; and web content that reproduces the contents of other
physical media created before the date the recipient is required to
comply with subpart I.
In addition to adding a new first part to the definition of
archived web content, the Department made one further change to the
definition from the NPRM. In the NPRM, what is now the second part of
the definition pertained to web content that is ``maintained''
exclusively for reference, research, or recordkeeping. In the final
rule, the word ``maintained'' is replaced with ``retained.'' The
revised language is not intended to change or limit the coverage of the
definition. Rather, the Department recognizes that the word
``maintain'' can have multiple meanings relevant to this rule. In some
circumstances, ``maintain'' may mean ``to continue in possession'' of
property, whereas in other circumstances it might mean ``to engage in
general repair and upkeep'' of property.\18\ In contrast, the third
part of the definition states that archived web content must not be
altered or updated after the date of archiving. Such alterations or
updates could be construed as repair or upkeep, but that is not what
the Department intended to convey with its use of the word
``maintained'' in this provision. To avoid confusion about whether a
recipient can alter or update web content after it is archived, the
Department instead uses the word ``retained,'' which has a definition
synonymous with the Department's intended use of ``maintain'' in the
NPRM.\19\
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\18\ Maintain, Black's Law Dictionary (11th ed. 2019).
\19\ See Retain, Black's Law Dictionary (11th ed. 2019) (``To
hold in possession or under control; to keep and not lose, part
with, or dismiss.'').
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Additional discussion of this term can be found at Sec. 84.85(a).
Companion
The proposed rule defined a ``companion'' as ``a family member,
friend, or associate of an individual seeking access to a program or
activity of a recipient, who, along with such individual, is an
appropriate person with whom the recipient should communicate.'' The
same definition is contained in the general section of the
communications subpart at Sec. 84.77(a)(2).
Comments: Representatives from many disability rights organizations
commented that the definition needs greater clarity. They said that it
is critical that recipients confirm the companion's role and, as
appropriate, obtain consent from the individual with a disability that
they want the
[[Page 40072]]
companion to participate in their care. Some commenters noted that this
concern is discussed somewhat in the communications section, but they
suggested that it be made clear that these standards apply in all
situations.
A disability rights organization asked that we clarify that the
determination as to who is an appropriate companion must rest with the
individual with a disability (or their designated decision-maker
pursuant to State law) and not with the recipient. They expressed the
view that that this is critically important because to not do so might
violate privacy laws and may also undermine the autonomy of people with
disabilities. They requested that the clarification language be added
to the text of the regulation.
Another disability rights organization similarly requested changes
to the regulatory text. They objected to the use of the term
``companion,'' which they believed is based on the stereotype that
treats all individuals with disabilities as eternal children who must
have a companion to communicate with recipients. They also objected to
the term because it implies that the companion is communicating with
the recipient independently rather than revoicing or repeating what the
person with disabilities wants to be expressed and understood.
According to the organization, this perpetuates an endemic and
unhealthy form of disability-based discrimination expressed in all
facets of society, but especially in health care. Commenters suggested
replacement of the term ``companion'' with the term ``communication
intermediary'' or an equivalent term that more accurately describes the
role. Their suggested definition for the new term is a person who
assists an individual with a disability to effectively communicate, to
be understood, and to understand others. The role of this person is to
relay information. Recipients must communicate with the individual with
a disability directly and respectfully, and they may not use the
presence of the other person as a reason to evade that obligation.
Response: We decline to revise the regulatory text, which is the
same that appears in the ADA title II regulations at 28 CFR
35.160(a)(2). While we appreciate commenters' concerns, the definition
makes clear that the companion must be ``an appropriate person with
whom the public entity should communicate.'' Consistent with the title
II regulation, this means the companion must be ``someone with whom the
public entity normally would or should communicate'' in the situation
at hand.\20\ This requirement ensures that companions with disabilities
receive effective communication even if the person that the companion
accompanies is not an individual with a disability. As to the commenter
who wanted a change in the word ``companion'' and provided language to
describe the duties of that person, we do not believe that revisions in
the text are needed, and it is beyond the scope of the Department's
responsibility as the person with a disability will determine the
appropriate duties for their companion. Accordingly, we decline to
revise the definition of companion.
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\20\ 28 CFR part 35, appendix A at 668 (2023).
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Conventional Electronic Documents
Discussion of this term can be found in subpart I. The Department
is deleting ``database file formats'' from the definition.
Current Illegal Use of Drugs
The proposed rule said that ``current illegal use of drugs'' means
illegal use of drugs that occurred recently enough to justify a
reasonable belief that a person's drug use is current or that
continuing use is a real and ongoing problem. This definition is
identical to the one in the ADA title II regulations.
Comments: The Department received many comments on this definition.
They uniformly had the same concern about the meaning of ``current.''
Many commenters said that the definition, which comes from ADA
regulations, is antiquated and does not take into account the
importance of understanding that for people with substance use
disorders, recurrence of use is common and it does not mean the
treatment is not or will not be successful. Instead, in many cases it
may mean that the current treatment plan is not working and should be
revisited and revised. Commenters maintained that without an expansive
and nuanced consideration of the non-linear nature of treatment and
recovery, including possible recurrent use, protections for people with
substance use disorders (SUD) are incomplete and inappropriately
distinguished from other forms of disability.
Response: The Department appreciates all commenters' feedback. The
Department acknowledges commenters' concerns. However, the phrase
``illegal use of drugs'' is used in both the ADA and the Rehabilitation
Act. Congress' intended meaning for the phrase is clear. As explained
in the preamble to the title II ADA regulations, the definition of
``current illegal use of drugs'' is based on the report of an ADA
Conference Committee, H.R. Conf. Rep. No. 596, 101st Cong., 2d Sess. 64
(1990). That Report says that ``current illegal use of drugs'' is use
``that occurred recently enough to justify a reasonable belief that a
person's drug use is current or that continuing use is a real and
ongoing problem.'' Both the ADA and the Rehabilitation Act define
``individual with a disability'' as not including an individual who is
currently engaging in the illegal use of drugs when a covered entity or
recipient acts on the basis of such use.
We therefore decline to revise the definition of ``current illegal
use of drugs.''
Direct Threat
The proposed rule said that ``direct threat'' means a significant
risk to the health or safety of others that cannot be eliminated by a
modification of policies, practices, or procedures, or by the provision
of auxiliary aids or services. With respect to employment, the term is
as defined by the Equal Opportunity Commission's regulation
implementing title I of the Americans with Disabilities Act of 1990, at
29 CFR 1630.2(r) (<a href="https://www.ecfr.gov/current/title-29/section-1630.2#p-1630.2">https://www.ecfr.gov/current/title-29/section-1630.2#p-1630.2</a>(r)).
Comment: The Department received comments from many disability
rights organizations recommending revisions to the term ``direct
threat'' as defined by the EEOC pursuant to its authority under title I
of the ADA. In addition, they objected to the statement in the proposed
rule's preamble that a person who poses a direct threat is not
``qualified.''
Many commenters said that whether an individual is qualified is a
threshold question for a person with a disability to establish, whereas
whether an individual poses a direct threat is an affirmative defense
for a recipient to establish. They recommended that we apply the direct
threat analysis as set out in the ADA title II regulations and they
provided a sentence that they would like inserted in the preamble.
Response: We appreciate the commenters' feedback. We note, however,
that the Department has no authority to change the definition in EEOC
regulations promulgated under title I of the ADA.
The definition of ``direct threat'' set forth in proposed paragraph
(1) was added to be consistent with the ADA title II regulation and
with the Supreme Court case of School Board of Nassau County v.
Arline.\21\ As to the request that we insert the commenters'
[[Page 40073]]
suggested language into the commentary, we reiterate the statement in
the NPRM preamble, which also mirrors appendix B to the ADA title II
regulation, that ``[a]lthough persons with disabilities are generally
entitled to the protection of this part, a person who poses a
significant risk to others constituting a direct threat will not be
`qualified' if reasonable modifications to the recipient's policies,
practices, or procedures will not eliminate that risk.'' It is
important that the interpretation of ``direct threat'' in paragraph (1)
of this rule and its interpretation in the ADA title II regulations be
consistent. Accordingly, we decline to revise the definition of
``direct threat.''
---------------------------------------------------------------------------
\21\ 480 U.S. 273 (1987).
---------------------------------------------------------------------------
Facility
The proposed rule defined ``facility'' as ``all or any portion of
buildings, structures, sites, complexes, rolling stock or other
conveyances, roads, walks, passageways, parking lots, or other real or
personal property, including the site where the building, property,
structure, or equipment is located.''
Comment: A commenter representing persons with disabilities
suggested adding language to address drive-through services. The
comment notes that courts have resisted accessibility requirements for
drive-through services and that drive-throughs are an important point
of access for obtaining prescription medication and were a first line
of service at the start of the COVID pandemic. The comment recommended
including ``product or service dispersing facilities and drive-
throughs'' in the list of items that constitute a facility.
Response: The Department believes it is not necessary to include
any new regulatory text because the facility housing drive-through
services is already included within the expansive text of the existing
language. Facility includes buildings, structures, passageways, and
equipment, which will cover all the areas that constitute the drive-
through facility. In addition, if offered, drive-through services are a
part of the recipient's program or activity and all the provisions of
the section 504 rule will apply to this service, ensuring that persons
with disabilities have access to this service.
We have retained the proposed definition of ``facility.''
Federal Financial Assistance
The proposed rule provided a detailed definition of ``Federal
financial assistance'' as any grant, cooperative agreement, loan,
contract (other than a direct Federal procurement contract or contract
of insurance or guaranty), subgrant, contract under a grant or any
other arrangement by which the Department provides or otherwise makes
available assistance in the form of funds, services of Federal
personnel, real or personal property or any interest in or use of such
property, or any other thing of value by way of grant, loan, contract,
or cooperative agreement. This definition is consistent with the
definition in the existing regulation, with addition of ``direct
Federal'' so that it reads ``(other than a direct Federal procurement
contract or a contract of insurance or guaranty)''. No substantive
change is intended from the existing definition.
Comment: Several commenters asked that the Department make clear
that tax-exempt status is not ``Federal financial assistance'' and thus
does not trigger the application of section 504. They noted that
several recent cases brought under title IX have held that tax-exempt
status is ``Federal financial assistance.'' \22\ They also state that
most other cases that have addressed whether tax-exempt status
constitutes Federal financial assistance for purposes of statutes
triggered by the receipt of such aid have held that tax-exempt status
is not Federal financial assistance and thus does not trigger coverage
of the statute in question.
---------------------------------------------------------------------------
\22\ See E.H. v. Valley Christian Acad., 616 F.Supp.3d 1040
(C.D. Cal. 2022); Buettner-Hartsoe v. Baltimore Lutheran High Sch.
Ass'n, No. RDB-20-3132, 2022 WL 2869041 (D. Md. Jul. 21, 2022) E.H.
v. Valley Christian Acad., 616 F.Supp.3d 1040 (C.D. Cal. 2022).
---------------------------------------------------------------------------
Response: Generally, tax benefits, tax exemptions, tax deductions,
and most tax credits are not included in the statutory or regulatory
definitions of Federal financial assistance.\23\ While a few courts
have held that tax-exempt status can constitute Federal financial
assistance, 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.\24\ Accordingly, this Department
generally does not consider tax exempt status to constitute Federal
financial assistance. However, the definition of ``Federal financial
assistance'' makes clear that Federal financial assistance that the
Department plays a role in providing or administering is considered
Federal financial assistance under this rule.
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\23\ See, e.g., 42 U.S.C. 2000d-1; 28 CFR. 42.102(c); 31 CFR
28.105. See also U.S. Dep't of Justice, Title VI Legal Manual, sec.
V.C.
\24\ See, e.g., Paralyzed Veterans of Am. v. Civil Aeronautics
Bd., 752 F.2d 694, 708-09 (DC Cir. 1985); Johnny's Icehouse, Inc. v.
Amateur Hockey Ass'n of Ill., 134 F. Supp. 2d 965, 971-72 (N.D. Ill.
2001); Chaplin v. Consol. Edison Co., 628 F. Supp. 143, 145-46
(S.D.N.Y. 1986); Bachman v. Am. Soc'y of Clinical Pathologists, 577
F. Supp. 1257, 1264-65 (D.N.J. 1983).
---------------------------------------------------------------------------
Comment: A commenter asked the Department to confirm that the
definition of Federal financial assistance in this rule does not limit
the scope of its proposed revision of regulations implementing section
1557. If finalized as proposed, the section 1557 regulations would,
consistent with the ACA, define ``Federal financial assistance'' to
include grants, loans, and other types of assistance from HHS, as well
as credits, subsidies and contracts of insurance in accordance with the
text of section 1557.\25\
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\25\ See ``Nondiscrimination in Health Programs and
Activities,'' 87 FR 47824, 47912 (Aug. 4, 2022).
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Response: Section 1557 is a separate statute from section 504 and
its regulation contains a more expansive definition of Federal
financial assistance than section 504 does.\26\ The definition of
Federal financial assistance in this regulation does not constrain or
otherwise limit the definition of Federal financial assistance under
the Department's section 1557 regulations.
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\26\ Id. The existing 1557 regulation at 45 CFR 92.3(a)(1)
(2020) also includes including credits, subsidies, or contracts of
insurance provided by the Department.
---------------------------------------------------------------------------
Comment: One commenter asked that the Department provide guidance
on whether section 504 requirements apply to State Medicaid programs
and managed care plans with which State agencies contract to administer
Medicaid services to beneficiaries.
Response: When HHS provides Federal financial assistance, including
grants, to an entity, section 504 obligations attach with the receipt
of the funds. In essence this relationship is in the form of a contract
between the Federal Government and the recipient, by which the
recipient states that it will not discriminate on the basis of
disability in its operation of its programs or activities as a
condition of the receipt of Federal funds.\27\ When the recipient
contracts out responsibilities under the grant program or disburses the
funds to other subgrantees that will also operate the program or
activity, these statutory and contractual obligations pass down to the
subgrantee or subcontractor.
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\27\ See 45 CFR 84.5 (``An applicant for Federal financial
assistance to which this part applies shall submit an assurance, . .
. that the program or activity will be operated in compliance with
this part.'')
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[[Page 40074]]
In the case of the Department's Medicaid program, State Medicaid
programs receive Federal funds and are therefore covered by section
504.\28\ When the State Medicaid agency provides Medicaid funds to
managed care plans to manage and operate specific Medicaid programs or
activities, those managed care plans are also subject to section 504.
---------------------------------------------------------------------------
\28\ See, e.g., U.S. v. Baylor Univ. Med. Ctr., 736 F.2d 1039,
1042 (5th Cir. 1984) (holding that ``Medicare and Medicaid are
federal financial assistance for the purpose of Section 504''),
cert. denied, 469 U.S. 1189 (1985).
---------------------------------------------------------------------------
We have retained the proposed definition of ``Federal financial
assistance.''
Foster Care
Comment: Commenters asked us to include the phrase ``either
directly or through contracts, agreements, or other arrangements with
another agency or entity'' to describe the covered recipients of
Federal financial assistance who provide foster care.
Response: The language ``recipient of Federal financial assistance
made directly or through contracts, agreements, or other arrangements''
is included in the child welfare section, Sec. 84.60(b), to describe
covered entities.
We decline to revise the definition of ``foster care.''
Individual With a Disability
The proposed rule said that an individual with a disability means a
person who has a disability but the term does not include an individual
who is currently engaging in the illegal use of drugs, when a recipient
acts ``on the basis of such use.''
Kiosk
Discussion of this term can be found at subpart I.
Most Integrated Setting
Discussion of this term can be found in Integration (Sec. 84.76).
Mobile Applications
The Department did not receive comments on the definition of this
term and is finalizing it without modifications.
Other Power-Driven Mobility Device
Discussion of this term can be found in Mobility Devices (Sec.
84.74).
Parents
Discussion of this term can be found in Child Welfare (Sec.
84.60).
Qualified Individual With a Disability
Comment: One group of commenters representing persons with
disabilities asked that the Department clarify that paragraph (3) in
the definition of qualified individual with a disability refers to both
public and private recipients.
Response: That paragraph refers to childcare, preschool,
elementary, secondary, or adult educational services and it encompasses
both public and private entities that are recipients from HHS. The
Department has revised paragraph (4) addressing postsecondary and
career and technical education services to be consistent with the
Department of Education regulations.
We decline to revise the definition of ``qualified individual with
a disability.''
Qualified Interpreter
Comment: Some commenters requested that the Department change the
definition of ``qualified interpreter'' to more closely align with the
definition of qualified interpreter for individuals with limited
English proficiency proposed by the Department in its recent NPRM for
section 1557.\29\
---------------------------------------------------------------------------
\29\ 87 FR 47824 (Aug. 4, 2022).
---------------------------------------------------------------------------
Response: The Department believes that the proposed definition of
qualified interpreter in this rulemaking accurately describes the
requirements of a qualified interpreter for people with disabilities.
Additionally, this definition is added for consistency with title II of
the ADA. For the many reasons explained in the NPRM, the Department
believes there is and should be consistency between the relevant
provisions of section 504 and title II of the ADA. Many recipients
under section 504 are also covered entities under the ADA and the
Department does not wish to cause confusion or adopt different
standards in those circumstances. Both recipients and individuals with
disabilities benefit from establishing consistent regulations.
We acknowledge that many recipients under section 504 are also
covered entities under the Department's recent final rule under section
1557. Recipients must meet their obligations under both laws. If an
interpreter does not adhere to generally accepted interpreter ethics
principles, including client confidentiality, as they are required to
do under section 1557, such an interpreter may not be a qualified
interpreter for purposes of section 504. A failure to adhere to ethics
principles may compromise the interpreter's impartiality and could also
prevent a recipient from providing communication that is as effective
as the recipient's communication with others (who, in the medical
context, are generally entitled to confidential communication).
Similarly, an interpreter that does not demonstrate proficiency in
communicating in, and understanding, (1) both English and any non-
English languages necessary to communicate effectively with an
individual with a disability, such as American Sign Language, or (2)
another communication modality (such as cued-language transliterators
or oral transliteration), is likely not a qualified interpreter under
section 504 because they are unlikely to be able to interpret
effectively and accurately, both receptively and expressively. In order
to interpret effectively, as they are required to do under section 504,
qualified interpreters should be able to interpret without changes,
omissions, or additions and while preserving the tone, sentiment, and
emotional level of the original statement. We decline to revise the
definition of ``qualified interpreter.''
Section 508 Standards
Discussion of this term can be found in subpart I.
Service Animal
Discussion of this term can be found at Service animals (Sec.
84.73).
State
The definition of ``State'' has been revised to more closely track
the definitions section of the Rehabilitation Act, 29 U.S.C. 705(34).
This is a not a substantive change.
WCAG 2.1
Discussion of this term can be found at subpart I.
User Agent
The Department has added a definition for ``user agent.'' The
definition exactly matches the definition of user agent in WCAG
2.1.\30\ WCAG 2.1 includes an accompanying illustration, which
clarifies that the definition of user agent means ``[w]eb browsers,
media players, plug-ins, and other programs--including assistive
technologies--that help in retrieving, rendering, and interacting [w]eb
content.'' \31\
---------------------------------------------------------------------------
\30\ See W3C, Web Content Accessibility Guidelines 2.1 (June 5,
2018), <a href="https://www.w3.org/TR/2018/REC-WCAG21-20180605/">https://www.w3.org/TR/2018/REC-WCAG21-20180605/</a> and <a href="https://perma.cc/UB8A-GG2F">https://perma.cc/UB8A-GG2F</a>. Copyright (copyright) 2023 W3C[supreg]. As
discussed below, WCAG 2.1 was updated in 2023, but this rule
requires conformance to the 2018 version. The Permalink used for
WCAG 2.1 throughout this rule shows the 2018 version of WCAG 2.1 as
it appeared on W3C's website at the time the NPRM was published.
\31\ Id.
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The Department added this definition to the final rule to ensure
clarity of the term ``user agent'' now that the term appears in the
definition of ``web
[[Page 40075]]
content.'' As discussed further at subpart I, the Department has more
closely aligned the definition of ``web content'' in the final rule
with the definition in WCAG 2.1. Because this change introduced the
term ``user agent'' into the Department's section 504 regulation for
recipients of Federal financial assistance, and the Department does not
believe this is a commonly understood term, the Department has added
the definition of ``user agent'' provided in WCAG 2.1 to the final
rule.
Additional discussion of this term can be found at subpart I.
Web Content
Discussion of this term can be found at subpart I. The Department
is editing this definition to more closely align with the definition
included in WCAG 2.1.
Wheelchair
Discussion of this term can be found in Mobility Devices (Sec.
84.74).
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing this section with six changes. First, we
are revising the definition of ``archived web content''; second, we are
revising the definition of ``conventional electronic documents'';
third, we are revising the term ``most integrated setting''; fourth we
are adding a definition of ``Section 508 Standards''; fifth, we are
adding a definition of ``user agent''; and sixth, we are revising the
definition of ``web content.''
Subpart B--Employment Practices
This subpart addresses the section 504 requirements in the area of
employment.
Discrimination Prohibited (Sec. 84.16)
Proposed Sec. 84.16(a) prohibited discrimination on the basis of
disability in employment under any program or activity receiving
Federal financial assistance from the Department.
Proposed Sec. 84.16(b) stated that the standards used to determine
whether there has been discrimination in this context shall be the
standards applied under title I of the ADA as they relate to
employment, and, as such sections relate to employment, the provisions
of sections 501 through 504 and 511 of the ADA as implemented in the
EEOC's regulation at 29 CFR part 1630.
The comments and our responses regarding subpart B are set forth
below.
Comment: Many organizations representing individuals with
disabilities supported clarifying employment obligations and aligning
the employment section of the rule with title I of the ADA. They noted
that individuals with disabilities are more likely than individuals
without disabilities to work in low paying jobs. Several commenters
said that workforces should include individuals with disabilities in
health care facilities, schools, and social work agencies to help
parents and caregivers navigate the systems. They stated that a robust
and disability aware workforce is needed to realize an equitable and
nondiscriminatory health care system. Several individuals described
their personal experiences of discrimination in the workplace.
Response: The Department appreciates the commenters' feedback on
the prohibitions against discrimination in employment and of the
requirement that the employment standards be aligned with title I of
the ADA. We agree that it is important for workforces to include
individuals with disabilities.
The Department notes that individuals who have experienced
discrimination in the workplace may file complaints with OCR, though
certain cases of employment discrimination may not be within OCR's
statutory jurisdiction and may result in a case referral to the
appropriate agency. As such, any person who believes they or another
party has been discriminated against on the basis of race, color,
national origin, sex, age, or disability, can visit the OCR complaint
portal to file a complaint online at <a href="http://ocrportal.hhs.gov/ocr/smartscreen/main.jsf">ocrportal.hhs.gov/ocr/smartscreen/main.jsf</a>. We also accept complaints by email at <a href="/cdn-cgi/l/email-protection#6e212d3c0d01031e020f07001a2e06061d40090118"><span class="__cf_email__" data-cfemail="1e515d4c7d71736e727f77706a5e76766d30797168">[email protected]</span></a>
and by mail at Centralized Case Management Operations, U.S. Department
of Health and Human Services, 200 Independence Avenue SW, Room 509F,
HHS Building, Washington, DC 20201.
Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing Sec. 84.16 as proposed with no
modifications.
Subpart C--Program Accessibility
Subpart C addresses program accessibility. It provides standards
for new construction and alterations and applies the concept of program
access for programs or activities carried out in new as well as
previously existing facilities, even when those facilities are not
directly controlled by the recipient.
Discrimination Prohibited (Sec. 84.21)
Section 84.21 proposed to require that, except as provided in Sec.
84.22, no qualified individual with a disability shall, because a
recipient's facilities are inaccessible to or unusable by individuals
with disabilities, be excluded from participation in, or be denied the
benefits of the programs or activities of a recipient, or be subjected
to discrimination by any recipient.
Existing Facilities (Sec. 84.22)
Section 84.22 currently provides that a recipient shall operate its
program or activity so that when viewed in its entirety, it is readily
accessible to individuals with disabilities, but does not require a
recipient to make each of its existing facilities accessible to and
usable by individuals with disabilities. Access to a program may be
achieved by a number of means, including reassignment of services to
already accessible facilities, redesign of equipment, delivery of
services at alternate accessible sites, and structural changes.
We proposed in Sec. 84.22(a)(2) to include language from the ADA
title II regulation and from the section 504 regulations for federally
conducted programs. It provides that, in meeting the program
accessibility requirement, a recipient is not required to take any
action that would result in a fundamental alteration in the program or
activity or in undue financial and administrative burdens. The
provision further states that the decision that compliance would result
in such alterations or burdens must be made by the head of the
recipient or their designee and must be accompanied by a written
statement of the reasons for reaching that conclusion. The provision
also states that if an action would result in such an alteration or
such burdens, the recipient shall take any other action that would not
result in such an alteration or such burdens but would nevertheless
ensure that individuals with disabilities receive the benefits or
services provided by the recipient. We proposed to retain Sec.
84.22(c). It provides that if a recipient with fewer than fifteen
employees that provides health, welfare, or other social services
finds, after consulting with a persons with a disability who is seeking
services, that there is no method of providing physical access to its
facilities other than making a significant alteration to its existing
facilities, the recipient may, as an alternative, refer the person with
a disability to other providers of the services that the person seeks
that are accessible.
New Construction and Alterations (Sec. 84.23)
Section 84.23(a) currently requires each facility (or part of a
facility)
[[Page 40076]]
constructed by, on behalf of, or for the use of a recipient, when such
construction was begun after June 3, 1977, to be designed and
constructed in such a manner that the facility (or part of a facility)
is readily accessible to and usable by individuals with disabilities.
Section 84.23(b) similarly currently requires that alterations to a
recipient's facility after June 3, 1977, that affect or could affect
the usability of the facility or part of the facility, shall, to the
maximum extent feasible, be altered in such a manner that the altered
portion is readily accessible and usable by individuals with
disabilities.
In the NPRM, Sec. 84.23(c) proposed language that lays out
accessibility standards and compliance dates for recipients that are
public entities. Section 84.23(d) lays out accessibility standards and
compliance dates for recipients that are private entities. The
Department's proposal seeks to use the Standards currently used in the
ADA: the 2010 ADA Standards for Accessible Design (2010 Standards).
Section 84.23(c) and (d) proposed to provide a series of compliance
dates for all physical construction or alterations. Under this
proposal:
If construction commences on or after one year from the publication
date of the final rule, the construction must comply with the 2010
Standards.
If construction commences on or after the effective date of the
rule, but before one year from the publication date of the final rule,
the construction must comply either with the Uniform Federal
Accessibility Standards (UFAS) or the 2010 Standards.
If construction commences on or after January 18, 1991, but before
the effective date of the final rule, the construction will be deemed
to be in compliance if it meets UFAS.
If construction commences after June 3, 1977, but before January
18, 1991, then the construction will be deemed to be in compliance if
it meets ANSI, the American National Standard Institute's
Specifications for Making Buildings and Facilities Accessible to, and
Usable by, the Physically Handicapped (ANSI A117.1-1961 (R1971)).
In Sec. 84.23(e), we proposed to provide that newly constructed or
altered facilities that do not comply with the section 504
accessibility standards that were in place at the time of construction
shall be made accessible in accordance with the 2010 Standards. In
addition, if the construction occurred on or after January 18, 1991,
and before the date one year from publication date of this rule in
final form the recipient has the option of using UFAS or the 2010
Standards as the accessibility standard.
In Sec. 84.22(g) of the NPRM, we proposed to follow the lead
established by DOJ in its ADA regulations and establish a safe harbor
for specific building elements. It clarifies that, if a recipient in
the past had constructed or altered an element in accordance with the
specifications of the accessibility code in effect at the time of
construction by HHS's section 504 rule (e.g., the specifications of
UFAS or ANSI), such recipient is not required to retrofit that element
to reflect incremental changes in this rule's accessibility standards.
In these circumstances, the recipient would be entitled to a safe
harbor for the already compliant elements until those elements are
altered.
The comments and our responses regarding subpart C are set forth
below.
Comments: Commenters were supportive of the Department's proposal
to retain the basic construct of its existing section 504 rule,
including strict compliance standards for new construction and
alterations and a program accessibility approach for programs carried
out in existing facilities. Many commenters, particularly individuals
with disabilities, expressed dismay that physical barriers continue to
exist so many years after the enactment of section 504, pointed out how
these barriers limit or deny access to health care, and strongly urged
the Department to take effective and vigorous action to enforce the
regulations that are being developed. Other commenters raised concerns
about specific issues in the Department's individual regulatory
sections and suggested alternative text and interpretations.
Response: The Department thanks those individuals who took the time
to share their experiences and concerns with the Department. These
comments provided support for the Department's decision to address
problems that persons with disabilities face in getting access to
health care and human services, particularly with respect to medical
treatment, accessible medical equipment, participation in child welfare
programs, and access to websites and kiosks. The Department remains
committed to maintaining its active enforcement program and notes that
persons who believe that they have been discriminated against in the
receipt of health care and social services may choose to file
complaints with the Department and the Department will review and
investigate complaints and work to achieve compliance with section 504
in those instances where the investigation reveals that discrimination
has occurred. The Department will respond to the additional points
raised by commenters in the individual sections that follow.
Scope of Accessibility
Comments: Several commenters expressed concern that the
Department's approach to program accessibility did not address a range
of other important access concerns. One commenter noted that access was
more than just building and that persons with environmental illness and
other invisible disabilities are denied access because of barriers
created by gases from carpeting and the use of air fresheners in
buildings. Another commenter included in its list of barriers that the
Department should be addressing the use of inaccessible shuttle
services offered by or for hospitals and operational concerns, such as
storage of items on wheelchair ramps, blocked doorways, or the use of
narrow or constricting rope lines.
Response: The Department notes that subpart C on Program
Accessibility is just one section 504 requirement and other provisions
in the rule address other aspects of accessibility. For example, the
list of general prohibitions against discrimination found at Sec. Sec.
84.68, particularly Sec. 84.68(b)(7) on reasonable modifications, and
84.70 on maintenance of accessible features, address the accessibility
concerns raised by these commenters.
Program Accessibility
Comments: Disability rights organizations expressed concern with
the Department's continued use of the program accessibility concept for
existing facilities. One organization recommended deletion of the
approach because of changes in the health care industry, i.e., the
propensity for horizontal and vertical consolidation where hospitals
merge, acquire smaller provider practices and specialty clinics, and
are in turn acquired by larger regional and nation health care
entities. The comment asserts that allowing accessible features in only
some of these facilities under the guise of overall program access will
deny persons with disabilities patient choice, care continuity, and
stakeholder consultation. Other commenters, including organizations
representing doctors and health care providers, expressed support for
the use of program accessibility and the flexibility that it provides
to small providers and approved of the Department's inclusion of the
use of the defenses of fundamental alteration and undue financial and
administrative burdens.
Others recommended that the Department maintain a high standard for
these defenses, allowing persons
[[Page 40077]]
with disabilities the opportunity to participate in and benefit from
health care services and programs. They also suggested that the rule
should include a prompt time frame for the decision by a recipient of
the use of these defenses so that an individual is not delayed access
because they must wait for a written decision. Another disability
rights organization expressed concern that the expanded use of
telemedicine, while necessary and important, should not replace regular
in-person visits in lieu of making the recipient's facilities
accessible.
Response: The program accessibility requirement has been a
significant feature of the Department's section 504 regulation since
1977 and is, in fact, a part of other Federal section 504 regulations,
both for federally assisted and federally conducted rules.\32\ The
Department notes that the program accessibility requirement is derived
from the language of section 504 itself, which prohibits discrimination
under any ``program or activity.'' The Department's regulation here is
also consistent with guidance from DOJ under E.O. 12250. DOJ's section
504 coordination regulation, which sets forth guidelines for Federal
agencies to follow in issuing section 504 rules, includes language on
program accessibility.\33\ That provision serves as a foundation for
the Department's section on program accessibility. Accordingly, the
Department will continue with the concept of program accessibility as
the basis for its treatment of how section 504 applies to existing
facilities in its final rule. The Department notes, however, that it
will continue to interpret the program accessibility concept broadly,
ensuring that persons with disabilities have access to appropriate
health care offered by recipients.
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\32\ See, e.g., 34 CFR 104.21 and 104.22 (Education); 24 CFR
8.20, 8.21, and 8.2 (HUD); 29 CFR 32.26 and 32.27 (Labor).
\33\ Pursuant to E.O. 12250, DOJ coordinates implementation of
section 504. 28 CFR part 41. The program accessibility requirements
can be found at 28 CFR 41.56 and 41.57.
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Section 84.22(a)(2) of the Department's proposed rule states that,
in meeting the program accessibility requirement, a recipient is not
required to take any action that would result in a fundamental
alteration in the nature of its program or activity or in undue
financial and administrative burdens. This paragraph does not establish
an absolute defense; it does not relieve a recipient of all obligations
to individuals with disabilities. Although a recipient is not required
to take actions that would result in a fundamental alteration in the
nature of a program or activity or in undue financial and
administrative burdens, it nevertheless must take any other steps
necessary to ensure that individuals with disabilities receive the
benefits or services it provides.
It is the Department's view that this paragraph already sets a high
bar and that compliance would in most cases not result in undue
financial and administrative burdens for a recipient. In determining
whether financial and administrative burdens are undue, all recipient
resources available for use in the funding and operation of the program
or activity should be considered. The burden of proving that compliance
would fundamentally alter the nature of a program or activity or would
result in undue financial and administrative burdens rests with the
recipient. The decision that compliance would result in such alteration
or burdens must be made by the head of the recipient or their designee
and must be accompanied by a written statement of the reasons for
reaching that conclusion. The Department recognizes the difficulty of
identifying the official responsible for this determination, given the
variety of organizational forms that may be taken by recipients and
their components. The intention of this paragraph is to require this
determination to be made by a high level official, no lower than a
Department head, having budgetary authority and responsibility for
making spending decisions. The Department recognizes that its
regulatory language does not contain any language about the timing of
the decision that an action is a fundamental alteration or would cause
an undue burden. Given the wide range of sizes and types of the
Department's recipients, the Department believes that setting any
specific timetable would be inappropriate. Of course, any person who
believes that they or any specific class of persons has been injured by
the recipient's decision or failure to make a decision may file a
complaint under the compliance procedures established by Sec. 84.98 of
this part, which incorporates procedural provisions applicable to the
Department's title VI of the Civil Rights Act of 1964 regulations.
As to the comment concerning telehealth, the Department notes its
discussion on this subject below at subpart H, Communications. The use
of telehealth is an important advance in the provision of health care,
but it is not the appropriate response for all situations and an in-
office visit remains an important tool in the recipient's arsenal of
health care solutions. Thus, telehealth in and of itself is not a
solution to the existence of a health care provider's inaccessible
facilities.
Small Providers (Sec. 84.22(c))
Comments: The Department received numerous comments on this
paragraph. Disability rights organizations expressed concern about the
Department's continued inclusion of a provision allowing a recipient
with fewer than fifteen employees to refer a patient to alternative
providers when the recipient finds, after consultation with a person
with a disability seeking its services, that there is no method of
complying with the program accessibility requirement other than making
a significant alteration in its existing facilities. Some commenters
suggested that this provision be deleted. Other commenters stated that
if a recipient must use an alternative to making its services
accessible, the recipient must take all steps necessary to provide the
services in the most integrated setting, and give due consideration to
the individual's preference after an individualized assessment of the
person's needs, and provide accessible transportation at no cost to the
patient. Organizations representing health care providers expressed
support for the alternative referral provision, noting that it helps
avoid circumstances in which complying with the rule's requirements
would present an insurmountable burden for small practices and
negatively impact a practice's resources for delivering care to all
patients.
Response: The Department is retaining this provision in the final
rule. It is necessary to keep this provision in the final rule because
it implements section 504(c) of the Rehabilitation Act. Section 504(c),
which Congress added to the statute in 1988, states that ``[s]mall
providers'' ``are not required by [section 504(a)] to make significant
structural alterations to their existing facilities for the purpose of
assuring program accessibility'' where ``alternative means of providing
the services are available.'' \34\ The Department believes that this
provision provides flexibility for the many very small providers that
the Department funds. One comment suggested reducing the scope of the
alternative referral to a smaller number of employees, perhaps five or
fewer employees. The Department considered this proposal, but believes
that changing this number here, when the fifteen or fewer number has
been consistently used by the Department for its section 504 regulation
since its inception, would likely cause confusion. In
[[Page 40078]]
addition, the Department notes that, in fact, a significant percentage
of the firms providing health care services (which includes doctors,
dentists, and other health care providers) have fewer than five
employees (52%) and an additional 20.4% have between five and nine
employees.\35\ The Department also notes that the consequences feared
by organizations representing persons with disabilities, i.e., that
doctors' offices in large numbers would use this alternative referral
provision to avoid making their offices accessible, has not been
historically proven true, even though this provision has been in the
Department's regulation since 1977.
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\34\ 29 U.S.C. 794(c).
\35\ U.S. Census Bureau, Stat. of U.S. Bus. (2019), <a href="https://www.census.gov/programssurveys/susb.html">https://www.census.gov/programssurveys/susb.html</a>.
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Accessibility Standard
Comments: Comments from organizations representing persons with
disabilities and a leader in the field of accessibility standards
strongly recommended not using the ADA Accessibility Standards as the
accessibility design standards in the final rule. They noted that the
2010 ADA Standards for Accessible Design is based on the U.S. Access
Board's (Access Board) 2004 Accessibility Guidelines and is already
out-of-date. They propose using the most current standard that exists
because the standard in the Department's rule will likely apply into
future decades. These groups recommend the use of the International
Building Code (IBC) 2021 Chapter 11 and the International Code Council
(ICC)/ANSI A117.1 in its entirety. They expressed the view that this
approach will provide greater overall accessibility for people with
disabilities and a higher level of buildings and facilities
accessibility than the 2010 Standards. They also state that ICC/ANSI's
A117.1 standards are the most current standards, have been developed by
the private sector, and are already in use by many State and local
jurisdictions. They state that these standards provide greater overall
accessibility to people with disabilities and that the Department's
proposed standards are based on knowledge and anthropometrics from 19
years ago (when the wheelchairs in use were smaller than those often
used today). In addition, many individual commenters related stories of
difficulties in accessing accessible health care and suggested that
whatever standards that the Department is using should address a wide
range of concerns (e.g., having an accessible front entrance to a
health care facility, or locating accessible room in hospitals close to
nursing stations and making their use convenient for the nursing
staff).
Response: While there are definite advantages to updating the
accessibility design standards in the final section 504 rule to the
most current standards, the Department believes that having different
standards for building accessibility for the ADA and section 504 would
create confusion and uncertainty for our recipients, most of whom would
be then subjected to two different standards for making their
facilities accessible. The Department is also aware that not all
jurisdictions in the United States have adopted the ICC/ANSI 117.1
requirements and adopting them in this rule would have significant cost
implications for those recipients in jurisdictions that have not yet
adopted the new ICC/ANSI standards. Further, the Department is aware
that the IBC is in the process of an even further update of these
standards that will address an important building block issue, the use
of a wider turning radius for larger wheelchairs.
Most importantly, however, the Federal Government already has in
place a process for updating its accessibility standards and the
Department believes that it should follow the existing procedure in
place. That process includes review of accessibility guidelines by the
Access Board, the agency in the Federal executive branch with the
necessary architectural expertise to determine the appropriate
accessibility guidelines, after conferring with all necessary
stakeholders through its own notice-and-comment process. Once the
Access Board updates its accessibility guidelines, Federal agencies
that enforce the ADA and section 504 (and other Federal laws requiring
accessible facilities) can move forward to adopt new, updated
accessibility standards, for both their federally assisted and
federally conducted programs. This process ensures that the Federal
Government will speak with one voice on the issue of accessible
building design.
The Department recognizes that its standards development process
can be a lengthy one and that the Federal process is slower and less
dynamic than the process followed by the private sector. The private
code process allows State and local jurisdictions to determine when,
whether, and in what detail they will adopt the IBC's most current
standards. Under the ADA and section 504, the Federal Government
requires the development of its standards through its notice-and-
comment process, a process that allows a full consideration of the
issue of costs and the needs for the latest approaches in accessible
design.
Accordingly, the Department will retain its use of the 2010 ADA
Standards for Accessible Design in its final section 504 rule. The
Department, as a member of the Access Board, will bring these concerns
to the full Board and will work toward an update of the Board's
Accessibility Guidelines.
Subpart D--Childcare, Preschool, Elementary and Secondary, and Adult
Education
Subpart D addresses requirements for childcare, preschool,
elementary and secondary, and adult education. It retains with slight
revisions the application section and the section dealing specifically
with those types of recipients. Other sections dealing with elementary
and secondary education are reserved.
Application of This Subpart (Sec. 84.31)
Section 84.31 of the NPRM proposed to require the subpart to apply
to childcare, preschool, elementary and secondary, and adult education
programs or activities that receive direct or indirect Federal
financial assistance and to recipients that operate, or that receive
Federal financial assistance for the operation of, such programs or
activities. The Department notes that childcare vouchers or
certificates are considered indirect Federal financial assistance and,
for the purposes of applying the Child Care and Development Block Grant
(CCDBG) regulations, are assistance to the parent. Section 504 applies
to both direct and indirect Federal financial assistance, including
vouchers. This subpart reaffirms that section 504 applies to child care
providers, but it does not change the conditions that apply to
recipients of indirect Federal financial assistance under any other
statute, such as the statute establishing the CCDBG program. For
example, faith-based child care providers that receive vouchers or
certificates through the Child Care and Development Fund (CCDF) are not
barred by that statute from providing religious programming and
materials, though section 504 applies to them. OCR will work with the
Administration for Children and Families to provide additional guidance
and implementation assistance to child care providers receiving Federal
financial assistance.
[[Page 40079]]
Childcare, Preschool, Elementary and Secondary, and Adult Education
(Sec. 84.38)
Section 84.38 proposed to prohibit these types of recipients, on
the basis of disability, from excluding qualified individuals with
disabilities and requires recipients to consider the needs of such
persons in determining the aids, benefits, or services to be provided.
The comments and our responses regarding subpart D are set forth
below.
Comment: Several commenters expressed support for the inclusion of
the term ``childcare'' in the new regulation, which uses currently
accepted terms and reduces unintended stigma related to references to
parents and children with disabilities by removing outdated phrases
such as ``handicapped.''
Response: The Department appreciates commenters' support and
believes using current terms plays an important role in inclusive and
accessible childcare programs.
Comment: Several commenters requested clarification that the age
range covered under Sec. 84.38 of subpart D begins at birth and
recommended this be made explicit in the final regulation.
Response: The Department appreciates this comment. A ``qualified
individual,'' as defined under section 504, can be of any age,
including from birth. Therefore, the Department declines to add further
text in the regulation.
Comment: Many commenters emphasized that childcare providers are
currently unaware of their obligations under section 504 and the ADA.
Commenters requested additional guidance from OCR and the
Administration for Children and Families (ACF) in how these providers
can meet their obligations, including assurance of availability of
supports, training opportunities, and resources including in plain
language and multiple languages. Additionally, some commenters asked
for guidance on how this rule should be read in concert with the
Department of Education's (ED's) section 504 rule in educational
settings. Lastly, commenters asked for clarification on how
disciplinary policies and practices will be applied in a
nondiscriminatory manner.
Response: The Department collaborates closely with our Federal
partners on section 504, including DOJ and ED. In collaboration with
ED, HHS recently updated a joint Policy Statement on Inclusion of
Children with Disabilities in Early Childhood Programs, which discusses
the legal foundation for inclusion and opportunities to improve
inclusion in early childhood programs.\36\ As explained in the NPRM,
the Department believes there is and should be consistency between the
relevant provisions of section 504 and title II of the ADA and its
regulation \37\ as well as ED's section 504 regulations.\38\ We
encourage recipients to consult DOJ's guidance titled ``Commonly Asked
Questions About Child Care Centers and the Americans with Disabilities
Act,'' first issued in 1997 and updated in 2020, that describes
providers' obligations under title III.\39\ In addition to consistency
in the relevant provisions, title II of the ADA and section 504
generally are interpreted consistently, as detailed in the NPRM.
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\36\ U.S. Dep't of Health & Human Servs., U.S. Dep't of Ed.,
Policy Statement on Inclusion of Children with Disabilities in Early
Childhood Programs (updated November 2023). The guidance notes that
`` `early childhood programs' refer to those that provide early care
and education to children birth through age five, including but not
limited to childcare centers, family childcare, Early Head Start,
Head Start, home visiting programs, and public and private pre-
kindergarten in-school and community-based settings.'' Id. at 1.
\37\ See 28 CFR part 35.
\38\ See 45 CFR 84.4(b)(2) and 34 CFR 104.4(b)(2).
\39\ U.S. Dep't of Justice, Commonly Asked Questions About
Childcare Centers and the Americans with Disabilities Act (2020),
<a href="https://www.ada.gov/childqanda.htm">https://www.ada.gov/childqanda.htm</a>.
_____________________________________-
Recipients should also be aware of the wealth of materials
available free of charge from the HHS-funded ADA National Network at
<a href="http://www.adata.org">www.adata.org</a>, including specific information about the provision of
childcare services.\40\ DOJ also provides guidance and resources at
<a href="http://www.ada.gov">www.ada.gov</a>.
---------------------------------------------------------------------------
\40\ The ADA National Network receives funding from HHS to
provide information, guidance and training on how to implement the
Americans with Disabilities Act (ADA).
---------------------------------------------------------------------------
HHS in coordination with ED, will work with childcare providers to
provide guidance and technical assistance on implementation. Both
Departments understand that providers will need information and
technical assistance to understand their obligations to individuals
with disabilities.
Comment: Several commenters expressed concern over discrimination
in childcare settings and asked that OCR provide additional guidance
regarding the criteria used to determine whether a modification is a
``fundamental alteration'' to a program or activity or an ``undue
financial and administrative burden'' for the purpose of
responsibilities under section 504. For example, several commenters
stated that modification requests for children with diabetes in
childcare settings frequently result in denial or exclusion. Commenters
asked for a non-exhaustive list of diabetes-related examples of what
reasonable modifications in childcare settings may include.
Response: We appreciate the commenters' request for additional
guidance on reasonable modifications. As throughout this regulation,
which modifications are reasonable and necessary to avoid
discrimination depends on the specific circumstances. Examples of
common reasonable modifications for a child with diabetes may include
providing or assisting with blood glucose checks, insulin
administration, counting carbohydrates, and taking action in response
to low and high blood glucose levels. DOJ's guidance titled ``Commonly
Asked Questions About Child Care Centers and the Americans with
Disabilities Act,'' provides relevant examples of reasonable
modifications under the ADA which also apply under section 504, such as
the use of service animals, assistance with diapering and toileting,
and assistance with orthotic devices.\41\ These scenarios are
illustrative examples of what reasonable modifications a covered entity
may be required to make to ensure a child with a disability can
participate in its programs. The Department will note the request for
more examples of reasonable modifications in our continuing education
and technical assistance efforts, including the issuance of possible
further guidance.
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\41\ U.S. Dep't of Justice, Commonly Asked Questions About
Childcare Centers and the Americans with Disabilities Act (2020),
<a href="https://www.ada.gov/childqanda.htm">https://www.ada.gov/childqanda.htm</a>; and see U.S. Dep't of Educ.,
Section 504 Protections for Students with Diabetes (2024), <a href="https://www2.ed.gov/about/offices/list/ocr/docs/ocr-factsheet-diabetes-202402.pdf">https://www2.ed.gov/about/offices/list/ocr/docs/ocr-factsheet-diabetes-202402.pdf</a>.
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Summary of Regulatory Changes
In light of the discussion above and considering the comments
received, we are finalizing subpart D as proposed with no
modifications.
Subpart E--Postsecondary Education
Subpart E addresses postsecondary education. The Department funds
many health-related schools that are covered by this part including
schools of medicine, dentistry, and nursing. This subpart is identical
to the postsecondary education provisions in the existing section 504
regulations and in the ED regulations at 34 CFR 104.41 through 104.47.
This subpart contains the following sections: Application, Admissions
and Recruitment, Treatment of Students, Academic Adjustments, Housing,
Financial and Employment Assistance to Students, and Nonacademic
Services.
[[Page 40080]]
The comments and our responses regarding subpart E are set forth
below.
Comment: Many commenters, including disability rights
organizations, said that access to postsecondary education, adult
education, and technical programs is critical for diversifying the
medical field. Several stated that disability should be included in the
curricula of all medical, nursing, and other health care professional
schools. One commenter urged HHS to take any actions that it can to
combat discrimination against individuals with disabilities at every
level of education, especially with regard to students and
practitioners in the fields of biomedical and behavioral research,
medicine, and allied health and human services. They asserted that this
is one of the most effective steps that can be taken to eradicate a
leading cause of the most egregious and endemic forms of disability-
based discrimination in the U.S. today.
Several other individuals similarly complained about the difficulty
in obtaining modifications and urged that the burden be alleviated. One
commenter said that recipients consistently require more than just a
clinical diagnosis of disability. He noted that obtaining other
documents is sometimes very difficult, especially for individuals who
live in rural areas.
Response: We thank commenters for their feedback. We agree with
those who commented on the importance of providing individuals with
disabilities equal access to educational programs and activities. We
also agree that disability should be addressed in the curricula of
postsecondary education programs. The Department currently has a
Medical School Curriculum Initiative in partnership with the
Association of American Medical Colleges.\42\
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\42\ For more information on this initiative, see U.S. Dep't of
Health & Human Servs, Off. for Civil Rts, Medical School Curriculum
Initiative in partnership with the Association of American Medical
Colleges, <a href="https://www.hhs.gov/civil-rights/for-individuals/special-topics/health-disparities/medical-school-curriculum-initiative/index.html">https://www.hhs.gov/civil-rights/for-individuals/special-topics/health-disparities/medical-school-curriculum-initiative/index.html</a>.
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In addition, the Department has authority to enforce the provisions
in subpart E which ensure that individuals receive equal access to
postsecondary educational programs. We are committed to vigorous
enforcement of those regulations. The Department notes that it proposes
in this final rule to promulgate Sec. 84.68(b)(7), which will be
particularly important for educational institutions as it will require
the provision of reasonable modifications to policies, practices, and
procedures when such modifications are necessary to avoid
discrimination on the basis of disability, unless the recipient can
demonstrate that making the modifications would fundamentally alter the
nature of the program or activity. Postsecondary educational
institutions must also comply with requirements specific to them
contained in Sec. 84.44, Academic Adjustments. That section requires
postsecondary educational institutions to make modifications to
academic requirements if necessary to ensure nondiscrimination on the
basis of disability. Modifications may include changes in the length of
time permitted for completion of degree requirements, substitution of
specific courses required for the completion of degree requirements,
and adaptation of the manner in which specific courses are conducted.
In response to the concern that recipients consistently require
more than just a clinical diagnosis of disability, we note that Sec.
84.4(d)(1)(vii) says that determining whether an impairment
substantially limits a major life activity usually will require no
scientific, medical, or statistical evidence. The preamble to that
provision in the ADA title II regulations states that ``in most cases,
presentation of such evidence shall not be necessary.'' \43\
Individuals who believe they have been unfairly denied reasonable
modifications and/or academic adjustments can file complaints with OCR.
The procedures for filing complaints are explained in Sec. 84.98.
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\43\ 35 CFR part 84, appendix C.
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Summary of Regulatory Changes
For the reasons set forth above and considering the comments
received, we are finalizing subpart E as proposed with no
modifications.
Subpart F--Health, Welfare, and Social Services
This subpart sets forth the requirements that apply to health,
welfare, and social service providers.
Substance and Alcohol Use Disorders (Sec. 84.53)
Proposed Sec. 84.53 retained the section of the existing
regulation with non-substantive terminology updates. The proposed
version stated that a recipient to which this subpart applies that
operates a general hospital or outpatient facility may not discriminate
in admission or treatment against an individual with a substance or
alcohol use disorder or individual with an alcohol use disorder who is
suffering from a medical condition, because of the person's drug or
alcohol use disorder.
We invited comment as to whether the application of this section
should extend beyond hospitals (including inpatient, long-term
hospitals, and psychiatric hospitals) and outpatient facilities. If so,
what types of treatment programs, providers, or other facilities should
be included in this section?
The comments and our responses regarding Sec. 84.53 are set forth
below.
Comment: Multiple commenters, including many disability rights
organizations, responded to our request for comment. The commenters
were uniformly supportive of the extension of coverage of this section
beyond hospitals and outpatient facilities. A few listed specific
health care facilities that should be included but most said that
coverage should be extended to ``all health care facilities.''
Several commenters questioned how the prohibitions in Sec. 84.53
are different from the prohibitions against discrimination in the
medical treatment section, Sec. 84.56. Another commenter was not clear
as to why we said that this section must be read in conjunction with
the illegal drugs provision at Sec. 84.69(b). A few commenters pointed
out a technical error in the text of the proposed rule where insertion
of the phrase ``or individual with an alcohol or substance use
disorder'' makes the sentence confusing.
Response: We thank commenters for their feedback and agree with
their unanimous recommendation that we expand the application of the
section to all health care providers.
There are many settings where individuals seek and receive care
other than hospitals and outpatient facilities. These include
rehabilitation centers, assisted living and residential care
facilities, day treatment programs, home health care services,
telehealth platforms, and specialty clinics. The current opioid crisis
and increase in substance use disorders underscores the necessity for
nondiscriminatory access to a wide range of health care facilities.
The Department believes that health care treatment should be as
inclusive as possible and should not be limited to hospitals and
outpatient facilities. Any health care facility receiving Federal
financial assistance from the Department may not discriminate in
admission or treatment against an individual with an alcohol or
substance use disorder who has a medical condition because of that
alcohol or substance use disorder. In response to a commenter's
question about how this section is different than the nondiscrimination
provisions in the
[[Page 40081]]
medical treatment section, we note that this section provides specific
protections for individuals with substance and alcohol use disorders
but that the general prohibitions against discrimination contained in
the medical treatment section at Sec. 84.56 also apply to that
situation.
With regard to the relationship of this section to the provisions
about illegal use of drugs contained in Sec. 84.69, we note that Sec.
84.69(a) states that ``[e]xcept as provided in paragraph (b) of this
section, this part does not prohibit discrimination against individuals
based on their current illegal use of drugs.'' The exception in
paragraph (b) states that ``a recipient shall not exclude an individual
on the basis of that individual's illegal use of drugs from the
benefits of programs and activities providing health services. . . .''
(emphasis added). The situation described in Sec. 84.53 fits into that
exception since it addresses individuals who are seeking health care
services. Accordingly, recipients cannot deny health services on the
basis of the current illegal use of drugs if the individual is
otherwise entitled to such services.
We note that Sec. Sec. 84.69 and 84.53 differ in two key ways.
First, Sec. 84.53 protects people with both substance use and alcohol
use disorders while Sec. 84.69 only addresses individuals engaging in
illegal use of drugs. Second, Sec. 84.69(b) prohibits exclusion of
individuals currently engaging in illegal use of drugs from health
services and services provided under the Rehabilitation Act while Sec.
84.53 does not address the illegal drugs issue. However, as noted
above, both regulations prohibit the exclusion of individuals currently
engaging in illegal use of drugs from health services although this is
not specifically stated in Sec. 84.53.
Please see the preamble discussion to Sec. 84.69, Illegal Use of
Drugs, for an explanation of how the ADA sections and Rehabilitation
Act sections on illegal drugs differ.
We agree with the commenters' suggestion that the text be clarified
by deleting the phrase ``or individual with alcohol use disorder.'' In
addition, we are making two technical changes--replacing the word
``drug'' with the word ``substance'' and replacing the phrase ``who is
suffering from a medical condition'' to ``who has a medical
condition.''
Summary of Regulatory Changes
For the reasons set forth above and considering comments received,
we are finalizing Sec. 84.53 as proposed with several modifications.
We are replacing the phrase ``operates a general hospital or outpatient
facility'' with the phrase ``operates a health care facility.'' In
addition, we are deleting the phrase ``or individual with an alcohol
use disorder'' the second time it is used, replacing the word ``drug''
with the word ``substance, and replacing the phrase ``suffering from a
medical condition'' to ``has a medical condition.'' The section now
says that ``[a] recipient . . . who operates a health care facility may
not discriminate in admission or treatment against an individual with a
substance or alcohol use disorder who has a medical condition, because
of the person's substance or alcohol use disorder.''
Education of Institutionalized Persons (Sec. 84.54)
Proposed Sec. 84.54 was retained from the existing section 504
regulations with one revision. The existing regulation stated that
recipients must ensure that qualified individuals with disabilities are
provided an appropriate education as defined in Sec. 84.33(b). That
section set forth the requirements for a free appropriate public
education. However, the proposed rule did not contain a Sec. 84.33(b)
as that section had been removed. Accordingly, we proposed to revise
Sec. 84.54 so that it refers instead to the ED section 504 regulations
at 34 CFR 104.33(b). The comments and our responses regarding Sec.
84.54 are set forth below.
Comment: Several disability rights organizations expressed concerns
about the reference to 34 CFR 104.33(b), ED's section 504 regulation,
since that Department has indicated their intent to amend their section
504 regulations. Their comments do not explain their concern; they
simply suggest that the rule not reference a regulation that will be
amended. The commenters proposed alternative language setting forth
requirements for an appropriate education. They also suggested that the
preamble state that this section is to be interpreted consistent with
the requirements of ED's section 504 regulations and the ADA title II
regulations.
Response: We appreciate the commenters' suggestions but decline to
revise the text of the regulation. We note that recipients must comply
with the current version of 34 CFR 104.33(b). If amendments to 34 CFR
104.33(b) are finalized, in whole or in part, following the effective
date of this regulation, then recipients must follow the amended
version in force at that time. The cross-reference to the ED regulation
does not change that requirement. We agree with recipients' assertion
that recipients must comply with both the ED and the ADA title II
regulations.
Summary of Regulatory Changes
For the reasons set forth above, we are finalizing Sec. 84.54 as
proposed without modifications.
Medical Treatment (Sec. 84.56)
Proposed Sec. 84.56(a) proposed a general prohibition against
discrimination to be read in conjunction with the general prohibitions
contained in proposed Sec. 84.68.
Proposed Sec. 84.56(b)(1) provided a non-exhaustive list of
examples of conduct that would violate the section. It stated that a
recipient may not deny or limit medical treatment to a qualified
individual with a disability when the denial is based on (i) bias or
stereotypes; (ii) judgments that an individual will be a burden on
others due to their disability; or (iii) a belief that the life of a
person with a disability has lesser value than the life of a person
without a disability, or that life with a disability is not worth
living.
In Sec. 84.56(b)(2), we proposed to provide that where an
individual with a disability seeks or consents to treatment for a
separately diagnosable symptom or medical condition, a recipient may
not deny or limit clinically appropriate treatment if it would be
offered to a similarly situated individual without an underlying
disability.
The Department invited comment on the best way of articulating
distinctions between underlying disabilities and separately diagnosable
symptoms or medical conditions.
We proposed in Sec. 84.56(b)(3) to provide that a recipient may
not provide medical treatment to an individual with a disability where
it would not provide the same treatment to an individual without a
disability unless the disability impacts the effectiveness, or ease of
administration of the treatment itself, or has a medical effect on the
condition to which the treatment is directed.
The Department invited comment on other examples of the
discriminatory provision of medical treatment. Proposed Sec. 84.56(c)
articulated a rule of construction setting forth a series of principles
guiding how proposed Sec. 84.56 should be interpreted. We proposed in
Sec. 84.56(c)(1)(i) to provide that nothing in this section requires
the provision of medical treatment where the recipient has a
legitimate, nondiscriminatory reason for denying or limiting that
service or where the disability renders the individual not qualified
for the treatment.
[[Page 40082]]
Proposed Sec. 84.56(c)(1)(ii) identified the circumstances when a
recipient typically declines to provide treatment and proposed that the
criteria in paragraphs (b)(1)(i) through (iii) would not be legitimate
nondiscriminatory reasons for denying or limiting medical treatment and
could not be a basis for determining that an individual is not
qualified for treatment or that a treatment is not clinically
appropriate.
The Department invited comment on the examples described in this
section, whether additional examples were needed and on the appropriate
balance between prohibiting discriminatory conduct and ensuring
legitimate professional judgments.
Proposed Sec. 84.56(c)(2) addressed the role of consent in
evaluating obligations under Sec. 84.56. We proposed in Sec.
84.56(c)(2)(i) to make clear that nothing in the section requires a
recipient to provide medical treatment to an individual where the
individual does not consent to the treatment. We proposed in Sec.
84.56(c)(2)(ii) to provide that nothing in the section allows a
recipient to discriminate against a qualified individual with a
disability in seeking to obtain consent.
We proposed in Sec. 84.56(c)(3) to provide that nothing in the
section precludes a recipient from providing an individual with a
disability with information regarding the implications of different
courses of treatment based on current medical knowledge or the best
available objective evidence.
The comments and our responses regarding Sec. 84.56 are set forth
below.
Comments: Commenters expressed broad support for the medical
treatment section, with many expressing particular support for the
general prohibition against discrimination. Many people with
disabilities shared experiences regarding the inappropriate denial of
medical treatment, while many provider organizations expressed
appreciation for the regulatory clarity and respect for professional
judgment in the proposed provision.
Response: The Department appreciates the broad support for this
section. We also thank all of the commenters who took the time to share
their experiences with us.
Comments: Many commenters indicated that further guidance, public
education, and technical assistance activities will be necessary to
promote compliance and awareness of the obligations of the new medical
treatment section. Examples include issuing supporting Frequently Asked
Questions, guidance for health care providers and others on the use of
supported decision-making and other reasonable modifications to support
accessibility and nondiscrimination, guidance on what is and is not a
legitimate, nondiscriminatory reason for denying or limiting a service,
expectations for documentation of legitimate nondiscriminatory reasons,
guidance on how the prohibition on discrimination in medical treatment
interacts with other sections of the regulation, and other topics.
Response: The Department agrees that further efforts may be
necessary to promote awareness of and compliance with the medical
treatment sections of this rulemaking. The Department will consider a
variety of options for such activities after the issuance of the final
rule, including sub-regulatory guidance and technical assistance.
Definition of Medical Treatment
Comments: Multiple commenters suggested the final rule should
include a definition of medical treatment. Many suggested changes to
the description of medical treatment included in the NPRM. Some
commenters suggested the Department include additional types of health
conditions to the description of medical treatment, specifically
suggesting additions such as intellectual, developmental, or behavioral
health conditions to the language ``physical and mental health
conditions'' in the proposed rule. Several commenters asked the
Department to clarify if habilitative services would be covered medical
treatment. Other commenters requested we use a new term entirely that
they believed would better encompass the breadth of treatment, like
``treatment options,'' ``health care services,'' ``comprehensive
medical care,'' ``medical services,'' or ``goods, benefits, or
services.'' Another commenter requested that we clarify that the term
is inclusive of services delivered in the context of clinical research.
Response: The Department has elected not to define the term
``medical treatment'' in the regulation, but instead uses the term in a
generic, nonspecific manner. As stated in the preamble to the proposed
rule, ``medical treatment'' is intended to be broad and inclusive. The
Department interprets medical treatment to encompass habilitative
services and services delivered as part of clinical research. The term
physical or mental health condition in the description of medical
treatment in the proposed rule is sufficiently broad to encompass the
additional, suggested language referenced by the commenters, including
intellectual, developmental, or behavioral health conditions, etc. We
will retain the approach in the proposed rule, giving ``medical
treatment'' its plain meaning, and reiterating that it is intended to
be broad and inclusive.
Notice
Comments: Several commenters requested that the Department require
all forms of medical treatment to include a notice of requirements
under section 504 to familiarize people with disabilities receiving
medical treatment from recipients with recipient obligations and
patient rights pursuant to them.
Response: We decline to make this change. Section 84.8, Notice,
requires all recipients to make available to beneficiaries and other
interested persons information about the provisions of section 504 and
its applicability to the programs or activities of the recipient.
Recipients must take such steps as necessary to apprise individuals of
the protections against discrimination assured them by section 504 and
this part, however we decline at this time to regulate how and when
recipients are required to do that.
Best and Promising Practices
Comments: Several commenters recommended best practices for
addressing disability discrimination, including competency-based
trainings on disability; a mechanism for allowing individuals with
disabilities to appeal medical treatment denials or limitations; a
structured process for requesting a second opinion/professional
consultation; and the availability of a specially trained, independent
review board--with a composition that includes people with a wide range
of disabilities--to consider patient appeals of medical treatment
decisions and report publicly on the outcome of those decisions.
Response: While these ideas are potentially promising practices for
assisting persons with disabilities as they seek health care, the
Department believes it is unnecessary to include these requirements at
this time to ensure compliance with section 504's nondiscrimination
requirement. Recipients may consider them as potential options within a
holistic strategy of providing health care to persons with
disabilities.
Utilization Management Practices
Comment: A medical organization asked the Department to respond to
an example under which ``a drug that slows the progression of visual
impairment is clinically appropriate only if a patient has a minimum
level of visual acuity remaining based on the enrolled populations in
the drug's
[[Page 40083]]
clinical trials,'' leading ``a Medicare Part D plan [to] place a prior
authorization requirement that the patient have that minimum level of
visual acuity for the drug to be covered by the plan.'' They ask the
Department whether such a prior authorization that would only cover the
drug for those with the minimum level of visual acuity would be viewed
as discriminatory under section 504.
Response: As indicated elsewhere within the preamble, prior
authorization and other utilization management activities are covered
by section 504 and Sec. 84.56. However, determining whether a
particular prior authorization or other utilization management decision
by a health plan may violate section 504 is a fact-specific inquiry
that we do not address in this final rule.
Interaction With Medicare
Comment: A medical organization noted their obligation under
Medicare Parts A and B and Medicare Advantage to allow coverage only
for items and services that are ``reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member'' as well as their obligation
under Medicare Part D to require that a drug be for a ``medically
accepted indication.'' They also ask that the Department include
specific regulatory language in the final rule deeming the application
of coverage restrictions in Federal health programs to meet the
proposed rule's standard for being nondiscriminatory and, therefore,
permissible.
Response: As the Department discusses elsewhere with respect to the
interaction of section 504's integration mandate and Medicaid law,
obligations under civil rights laws and program statutes, such as for
Medicare, are separate and distinct. Recipients are not required to
fundamentally alter their programs or activities to comply with section
504. However, recipients may be obligated to make reasonable
modifications to programs or services in order to comply with section
504 even if they are fully in compliance with applicable program
statutes in Federal health programs. As such, the Department has
elected not to modify the regulatory text.
Scope of Sec. 84.56
Comment: One commenter requested that we make clear that the
general prohibitions on discrimination in proposed Sec. 84.68 continue
to apply in the context of medical treatment notwithstanding proposed
Sec. 84.56's more specific provisions on discrimination in medical
treatment.
Response: The general prohibition against discrimination in
proposed Sec. 84.68 continues to apply in the context of medical
treatment. While Sec. 84.56 articulates more specific prohibitions,
this does not preclude the application of Sec. 84.68's more general
requirements to medical treatment or any of the other areas in which
the Department has included more specific regulatory provisions, nor
should the omission of a specific regulatory provision on a particular
topic be construed to suggest that the general prohibition against
discrimination does not apply in that context.
Comments: Several commenters suggested modifying Sec. 84.56(a) to
clarify that its prohibition on discrimination encompasses offering,
failing to offer, or denying a treatment.
Response: The Department agrees that Sec. 84.56(a)'s prohibition
on discrimination on the basis of disability can encompass instances
where a recipient offers, fails to offer, or denies a treatment. Other
provisions within the rule which provide further detail on the
prohibitions within Sec. 84.56(a) explicitly indicate this, such as
Sec. 84.56(b). We believe these prohibitions are covered by the rule
already, and thus decline to change the regulatory text.
Comments: Several commenters asked the Department to clarify how
Sec. 84.56 applies to payers, including Medicaid managed care plans,
Medicare Advantage plans, and other health systems payers receiving
Federal financial assistance.
Response: Section 84.56 applies to all medical treatment provided
by recipients receiving funds from HHS. The application of Sec. 84.56
in such instances will depend on the specific facts and institutional
context of each case.
Comments: Many commenters asked the Department to specifically
clarify other forms of medical treatment that Sec. 84.56 would apply
to, including assisted reproductive technology treatment, suicide
prevention services, mental health services, and others.
Response: As indicated previously, the Department intends Sec.
84.56 to apply in a broad and inclusive fashion to a wide array of
medical treatment services, including assisted reproductive technology
treatment, suicide prevention services, mental health services, and
others. ``Medical treatment'' is used in Sec. 84.56 in a generic,
nonspecific manner; it is intended to be broad and inclusive. It refers
to the management and care of a patient to identify, address, treat, or
ameliorate a physical or mental health condition, injury, disorder, or
symptom, whether or not the condition constitutes a disability and
whether the medical approach is preventive, curative, habilitative,
rehabilitative, or palliative. Although it is not possible to provide
an exhaustive list of such services, recipients should interpret the
term medical treatment in the broad and inclusive fashion intended by
the Department.
Comments: Some commenters requested the Department clarify that
Sec. 84.56 applies both to patients with disabilities that predate the
provision of medical treatment in which discrimination occurs, and
patients whose prognosis during that episode of medical treatment
includes disability.
Response: As discussed elsewhere in this rulemaking, the definition
of disability under section 504 is intended to be interpreted in a
broad and inclusive fashion. The definition of disability includes
people with disabilities whose disability predates the provision of
medical treatment in which discrimination occurs. As far as the
question of patients whose prognosis during the episode of medical
treatment includes disability, people with physical or mental
impairments that substantially limit a major life activity, including a
major bodily function, qualify as people with disabilities. As
indicated elsewhere within the rule, ``major life activities'' includes
not only activities such as caring for oneself, seeing, hearing, and
walking, but also includes the operation of a major bodily function
such as the functions of the immune system, normal cell growth, and
reproductive systems. Where a person's prognosis is the result of
impairments in a major bodily function, they would be considered a
person with a disability under section 504. We note also that section
504 protects persons who are ``regarded as'' having such an impairment.
In cases of illness or injury so severe that a person needs a
ventilator and tube feeding, or where a person is regaining
consciousness after brain injury, as raised in comments received on
this issue, although it will be a fact-specific inquiry, the
individuals in these scenarios would almost certainly be covered under
the definition of disability and by the protections from discrimination
on the basis of disability under section 504, including Sec. 84.56.
Comments: Several commenters asked the Department to clarify the
application of Sec. 84.56 to newborn infants.
Response: As indicated within the NPRM, the Department considers
[[Page 40084]]
section 504, including Sec. 84.56, to apply to newborn infants. This
includes the prohibitions against the denial of medical treatment under
Sec. 84.56(b)(1) and (2), and the prohibitions on the discriminatory
provision of medical treatment under Sec. 84.56(b)(3).
Comment: One commenter objected based on its understanding that the
Department's proposed rule would not apply to decisions to withhold
treatment from infants with disabilities in which the disabling
condition is related to the condition to be treated, noting that Sec.
84.56(b)(2) addresses treatment for a separately diagnosable condition
or symptom and not for the underlying disability. The comment concerned
infants with disability conditions such as meningomyelocele,
hydrocephaly, microcephaly, or other anatomical anomalies. The comment
noted that failure to treat these conditions represents discrimination
against a child with a disability.
Response: The Department believes that this comment misconstrues
the section 504 rule. The Department intends that this rule will
generally apply to the provision of medical treatment for infants,
including those seeking treatment for separately diagnosable symptoms
or conditions related to their underlying disability, when medical
treatment is provided to other similarly situated children. For
example, an infant with microcephaly may experience seizures. This
would constitute a separately diagnosable symptom or condition for
which treatment would be subject to the protections of Sec.
84.56(b)(2) despite the fact that the seizures are a symptom of the
infant's microcephaly. As the Department's NPRM made clear, with
respect to separately diagnosable conditions, the rule will not require
that the condition be entirely unrelated to the underlying disability.
``Nor does it matter for these purposes whether the condition for which
the individual is seeking treatment is in some sense causally related
to the underlying disability if the decision to refuse treatment would
not be made as to similarly situated individuals without the
disability.'' 88 FR 63405. In addition, Sec. 84.56(b)(1) prohibits
denying or limiting medical treatment to a qualified individual with a
disability based on bias or stereotypes about that patient's
disability, judgments that the individual will be a burden on others
due to their disability, or a belief that the life of a person with a
disability has a lesser value than the life of a person without a
disability or that life with a disability is not worth living. Under
such circumstances, the discrimination described by the commenter would
also be covered under Sec. 84.56(b)(1) even if the condition for which
the patient sought treatment was not a separately diagnosable symptom
or condition from their underlying disability.
Medical Futility
The Department proposed Sec. 84.56(b)(1)(iii) to prohibit
recipients from denying or limiting medical treatment based on the
provider's belief that the life of a person with a disability has a
lesser value than a person without a disability, or that life with a
disability is not worth living.
Comments: The Department received a broad array of comments from
disability organizations, civil rights organizations, and other
stakeholders supporting this approach. We received stories from people
with disabilities describing their own experiences or those of friends
regarding the denial of life-sustaining treatment and the difficulties
involved in accessing it after such denials. We also received similar
stories from providers. For example, one provider association described
a 25-year-old patient with a developmental disability who had been
referred to an inpatient hospice unit after becoming poorly responsive
with brain imaging demonstrating a shunt and severe abnormalities.
After the provider learned from a family member of a recent sudden
change in the patient's behavior, the patient received a second
opinion, leading to the shunt being surgically revised, the patient's
condition improving, and her enjoying her life for many more years. In
the words of this commenter, the patient's ``referral to hospice
without sufficient exploration of other treatment options was
inappropriate and may have been driven by a mistaken clinical
assumption regarding her baseline quality of life.''
Response: The Department will retain the provision as proposed. We
respond to specific questions regarding the application of this
requirement throughout this section.
Comments: Several commenters requested that the Department provide
an example of the application of Sec. 84.56(b)(1)(iii) to people with
intellectual disabilities.
Response: The Department provided such an example within the NPRM.
We noted an illustrative example in which a teenage boy with
intellectual and developmental disabilities develops periodic treatable
respiratory infections and pneumonia due to a chronic condition.
Judging his quality of life to be poor due to cognitive and
communication disabilities, his provider decides to withhold
antibiotics and other medical care when the boy becomes ill. Instead,
his provider--who is a recipient of Federal financial assistance--
refers the boy to hospice care and declines to provide life-sustaining
treatment. The provider makes this decision not because she anticipates
that care would be ineffective, but because she determines that such
care would be effective at prolonging the patient's life and that the
patient's life would not be worth living on the basis of the patient's
disability. Because the provider has withheld life-sustaining care
based on the judgment that the patient's life as an individual with a
disability is not worth living, the boy is a qualified individual who
has experienced discrimination on the basis of disability in violation
of Sec. 84.56(b)(1)(iii).
Comment: A commenter asked for additional clarity regarding the
permissibility of not offering treatment where doing so ``does not
align with the patient's wishes, does not take into account their
overall prognosis, does not consider whether the risks would outweigh
the benefits, or creates a situation where the treatment could cause
more harm than good.''
Response: The commenter raised multiple potential rationales for
denying treatment, each of which has different legal implications under
Sec. 84.56 and section 504 more generally. As the Department indicates
in Sec. 84.56(c)(2), ``Nothing in this section requires a recipient to
provide medical treatment to an individual where the individual, or
their authorized representative, does not consent to that treatment.''
As such, recipients will not be required to provide treatment that does
not align with a patient's expressed wishes or advanced directive.
The permissibility of denial of treatment based on other potential
rationales raised by the commenter are context- and fact-dependent. We
indicate in Sec. 84.56(c)(1)(i) that nothing in this section requires
the provision of medical treatment where the recipient has a
legitimate, nondiscriminatory reason for denying or limiting that
service or where the disability renders the individual not qualified
for the treatment. Where a patient's prognosis affects whether
treatment is likely to be effective, it may be permissible to consider
prognosis in determining whether a treatment should be provided.
Similarly, where a treatment is likely to have substantial side effects
that may outweigh the likely benefits to the patient, it may be
permissible to take these into account in determining whether a
treatment should be provided
[[Page 40085]]
as these risks are relevant to whether a treatment is medically
effective. However, consideration of a patient's prognosis may not
include a judgment that the life of a person with a disability is not
worth living or will be a burden on others due to their disability, as
these are prohibited criteria under Sec. 84.56(b)(1)(i) through (iii).
In short, while recipients may take into account potential harms to the
patient, those harms may not include or be based on a belief that the
patient would be better off dead than alive due to their disability.
Comments: In the NPRM, the Department provided an example involving
a patient with Alzheimer's disease, covered as a disability under
section 504, who has developed pneumonia and needs a ventilator to
provide assistance breathing. His husband has requested that physicians
start the patient on a ventilator, consistent with what the patient's
husband believes would be his spouse's wishes. The attending physician,
who is a recipient of Federal financial assistance from HHS and works
in a hospital that is also a recipient, tells the patient and his
husband that the patient should not receive a ventilator, given the
poor quality of life the physician believes the patient experiences
because the latter has Alzheimer's disease. This situation occurs even
though the attending physician normally would start ventilator support
for a patient with pneumonia who needs assistance breathing. The
physician believes that the patient's Alzheimer's disease renders the
continuation of the patient's life to have no benefit, and therefore
the physician declines to put the patient on the ventilator. We
indicated that under these circumstances the physician has denied life-
sustaining care for the patient based on judgments that the patient's
quality of life renders continued life with a disability not worth
living and has failed to provide care that he would have provided to an
individual without a disability. In denying access to ventilator
support, the doctor has violated Sec. 84.56(b)(1)(iii).
We received multiple comments specific to this example. Most
commenters, particularly those representing aging and disability
advocacy organizations, praised its inclusion, noting that it addressed
an important issue facing both people with Alzheimer's and those with
other cognitive disabilities, and requesting that it be incorporated
within the final rule. A minority of commenters expressed concern with
the use of Alzheimer's disease and suggested the Department consider
the use of another diagnosis or specify that only ``early and mild''
Alzheimer's is covered in the circumstances described by the
illustrative example.
Response: The example describes the denial of medical treatment due
to the provider's belief that the patient has such poor quality of life
due to their disability that life-sustaining treatment would not be of
benefit to them. This is a denial of treatment based on a belief that
life with the patient's disability is not worth living, a prohibited
basis for a denial of medical treatment under Sec. 84.56(b)(1)(iii)
and not a legitimate nondiscriminatory reason to deny treatment, as
specified under Sec. 84.56(c)(1)(ii). The example also indicates that
this occurs even though the attending physician normally would start
ventilator support for a patient with pneumonia who needs assistance
breathing. We note that if the physician reasonably determines based on
current medical knowledge or the best available objective evidence that
such medical treatment is not clinically appropriate for the patient
due to their Alzheimer's disease, this would not constitute prohibited
discrimination. However, such a determination cannot--consistent with
Sec. 84.56(c)(1)(ii)--be based on a judgment that the patient's life
is not worth living due to their Alzheimer's disease.
We note that the prohibition against denying treatment due to a
judgment that the patient's quality of life would be so low as to make
their life not worth living does not mean that a physician cannot
communicate this concern to the patient or their authorized
representative to inform their decision-making, provided the physician
does not discriminate on the basis of disability in the manner in which
they seek permission to withdraw or encourage the declining of life-
sustaining treatment (such as through pressuring the patient or their
representative). This was why we specified in this example that the
patient's authorized representative had sought medical treatment for
the patient with Alzheimer's disease and that this treatment would have
been provided to a similarly situated person without Alzheimer's
disease.
Comment: Organizations representing older adults and people with
disabilities asked the Department to interpret the permissible
application of medical futility narrowly and indicated that recipients
must explicitly take into account disability accommodations when making
determinations of medical futility. They also ask the Department to
include examples of the consideration of reasonable modifications when
making decisions regarding medical futility.
Response: In the NPRM, the Department noted a 2015 policy statement
from the American Thoracic Society, the American Association for
Critical Care Nurses, the American College of Chest Physicians, the
European Society for Intensive Care Medicine, and the Society of
Critical Care Medicine entitled ``Responding to Requests for
Potentially Inappropriate Treatments in Intensive Care Units.'' In the
statement, the term medical futility was defined more narrowly,
referring only to ``treatments that have no chance of achieving the
intended physiologic goal.'' The policy statement contrasts this narrow
definition of futility with broader definitions that include futility
based on quality-of-life judgments, stating that ``broader definitions
of futility are problematic because they often hinge on controversial
value judgments about quality of life or require a degree of prognostic
certainty that is often not attainable.'' \44\
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\44\ G.T. Bosslet et al., An official ATS/AACN/ACCP/ESICM/SCCM
Policy Statement: Responding to Requests for Potentially
Inappropriate Treatments in Intensive Care Units, 191 a.m. J.
Respiratory & Critical Care Med. 1318 (June 2015).
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The Department considers the former description of medical
futility--``treatments that have no chance of achieving the intended
physiologic goal''--to represent a permissible instance of the denial
of treatment under Sec. 84.56 as a person with a disability for whom a
treatment will not achieve the intended physiologic goal is not a
qualified individual with a disability. In contrast, the denial of
treatment due to ``value judgments about quality of life'' would likely
constitute a prohibited denial of treatment under Sec.
84.56(b)(1)(iii). Where futility is applied based on ``a degree of
prognostic certainty that is often not attainable,'' whether this would
constitute a prohibited denial of treatment would depend on if the
level of prognostic certainty is less rigorous than that which would be
applied to a similarly situated patient without a disability.
The Department agrees with the commenter that recipients must take
into account reasonable modifications required under section 504 when
evaluating whether a given patient with a disability meets this
standard. For example, some clinical protocols have made use of
``therapeutic trials'' involving the provision of mechanical
ventilation for a set period of time to evaluate the effectiveness of
ventilator treatment for a particular patient, under which patients
must meet a set
[[Page 40086]]
threshold or trajectory for continued treatment to be deemed non-
futile. However, as the Department previously noted within the NPRM,
patients with particular types of disabilities may take longer to
respond to treatment, and the test period may need to be longer to
accurately evaluate the effectiveness of mechanical ventilation for
these patients. In this situation, a recipient may need to allow an
individual with a disability some additional time on a ventilator to
assess likely clinical improvement, unless doing so would constitute a
fundamental alteration of the ventilator trial.
Comments: Several commenters asked the Department to clarify that
the ongoing need for assistive technology, attendant care, or other
physical assistance with activities of daily living, mechanical
ventilation, supervision, or other disability support needs does not
constitute sufficient reason to deny a qualified individual with a
disability access to medical treatment. They also seek clarification
that the fact that a person with a disability will not recover to their
pre-treatment baseline is not sufficient basis to deny medical
treatment that would succeed at prolonging a patient's life.
Response: The Department agrees. A recipient generally may not deny
medical treatment to a qualified individual with a disability,
including via a medical futility determination, simply because the
patient will require ongoing support during or after receiving medical
treatment. As indicated in the NPRM, people with disabilities
frequently report having a good quality of life notwithstanding their
need for assistance in many of the areas cited in the literature as a
basis for a futility determination, such as mechanical ventilation, the
use of assistive technology, the need for ongoing physical assistance
with activities of daily living, mobility impairments, cognitive
disability, and other similar factors. Similarly, the fact that a
patient with a disability may not recover to their pre-treatment
baseline is generally not sufficient basis to justify denying of
medical treatment, including via a medical futility determination.
The Department noted in the NPRM that determinations that an
individual with a disability's life is not worth living because of
dependence on others for support or need for mechanical ventilation,
intensive care nursing, tracheotomy, or other ongoing medical care rest
on judgments that do not properly relate to the individual's
qualification for medical treatment under section 504. Qualification
for the service of life-sustaining treatment must be based on whether
the treatment would be effective for the medical condition it would be
treating, not broader societal judgments as to the relative value of a
person's life due to their disability or whether life with a disability
is worth living.
Many people with disabilities require these kinds of supports,
often on a long-term basis, to survive and thrive. With such supports,
individuals with disabilities can and do live many years, enjoying
meaningful social, family, and professional relationships. By denying
patients with disabilities the opportunity to make their own decisions
regarding whether to receive or continue medically effective life-
sustaining care, recipients override patient autonomy in favor of their
own beliefs regarding the value of the lives of individuals with
disabilities who are dependent on others or on medical equipment or
technology.
Crisis Standards of Care
Comments: The Department received a broad array of comments on the
application of Sec. 84.56 to crisis standards of care.
Many comments asked the Department to confirm the application of
section 504 and Sec. 84.56 to crisis circumstances, provide additional
examples of crisis standards of care obligations within the preamble or
regulatory text, and respond to inquiries regarding the application of
Sec. 84.56 to these contexts.
Response: The Department confirms that section 504 and Sec. 84.56
apply during the planning, development, activation, and implementation
of crisis standards of care.
Comments: Many commenters noted that during the COVID-19 public
health emergency many State crisis standards of care plans included
both categorical exclusions from crisis care on the basis of specific
disabilities and other instances of unfavorable treatment against
people with specific disabilities (such as relative de-prioritization
for scarce critical care resources). These commenters asked the
Department to clarify the obligations of section 504 with respect to
categorical exclusions and other instances of unfavorable treatment on
the basis of specific disability diagnoses (such as cancer, cystic
fibrosis, dementia, or intellectual disability) or on the basis of
functional impairments (such as difficulty with activities of daily
living).
Response: As indicated under Sec. 84.56(b)(2), when a qualified
individual with a disability seeks or consents to treatment for a
separately diagnosable symptom or medical condition (whether or not
that symptom or condition is a disability under this part or is
causally connected to the individual's underlying disability), a
recipient may not deny or limit clinically appropriate treatment if it
would be offered to a similarly situated individual without an
underlying disability. When a crisis standards of care plan indicates
that patients with specific disabilities will be categorically
excluded, given lower priority, or otherwise will receive unfavorable
treatment when seeking access to critical care resources, this may be a
denial of treatment for a separately diagnosable symptom or medical
condition that would be provided to a similarly situated individual
without an underlying disability. If the patient with a disability is
qualified to receive such treatment, this may constitute a violation of
Sec. 84.56(b)(2). This analysis applies both to unfavorable treatment
on the basis of specific diagnoses and on the basis of functional
impairments that constitute disabilities under section 504.
We discuss here some relevant considerations regarding
qualification to receive treatment in the crisis standards of care
context. Categorical exclusions on the basis of disability in crisis
standards of care are prohibited when treatment would not be futile for
all individuals with that type of disability i.e., that the treatment
has no chance to achieve the intended physiologic goal for all persons
with that particular type of disability. For example, a hospital is
generally prohibited from having a categorical exclusion denying
ventilator treatment to individuals with Down syndrome because
ventilator treatment is not futile for all persons with Down syndrome.
Deprioritization of people with disabilities compared to people without
disabilities and other instances of unfavorable treatment can also
constitute violations of Sec. 84.56, if the disability receiving
unfavorable treatment does not impact short-term mortality. A patient's
disability should not form the basis for decisions regarding the
allocation of scarce treatment for a separate medical condition or
symptom, unless that underlying condition is so severe that it would
prevent the treatment sought from being effective or prevent the
patient from surviving until discharge from the hospital or shortly
thereafter.
We note that there are instances where Sec. 84.56 prohibits
discriminatory treatment in crisis standards of care even where a
patient is not seeking treatment for a separate symptom or condition
but instead seeks treatment for their own underlying disability. For
instance, Sec. 84.56(b)(1) clarifies that
[[Page 40087]]
unfavorable treatment, including categorical exclusions and
deprioritization, based on bias or stereotypes about a patient's
disability; judgments that the individual will be a burden on others
due to their disability, including, but not limited to caregivers,
family, or society; or a belief that the life of a person with a
disability has lesser value than the life of a person without a
disability, or that life with a disability is not worth living are
violations of Sec. 84.56 regardless of what type of medical treatment
the patient is seeking.
Comments: Many commenters asked the Department to discuss the
application of section 504 and Sec. 84.56 to instances of denial of
medical treatment on the basis of judgments of long-term life-
expectancy as a result of a patient's disability, a common feature of
many crisis standards of care plans.
Response: As the Department has previously indicated in its
February 2022 guidance, recipients may not deny or give lower priority
to patients with disabilities because of a judgment that their long-
term life expectancy may be lower than an individual without a
disability after treatment.\45\ Section 504 prohibits recipients,
including those implementing crisis standards of care, from imposing or
applying eligibility criteria that screen out or tend to screen out
individuals with disabilities, or any class of individuals with
disabilities, from fully and equally enjoying a program or activity,
unless such criteria can be shown to be necessary for the provision of
the program or activity being offered.\46\ In the context of crisis
standards of care implementation, which is designed to address resource
shortages in a temporary emergency, a patient's likelihood of survival
long after hospital discharge, which may depend upon many factors and
may be difficult to predict, is unlikely to be related to the need to
make allocation decisions about scarce resources on a temporary
basis.\47\ The further in the future a provider forecasts, the less
likely survival has to do with the effectiveness of the medical
intervention in the context of the public health emergency
necessitating crisis standards of care. Judgments about long-term life
expectancy are inherently uncertain and may screen out or tend to
screen out individuals with disabilities from access to care without
being necessary for the safe provision of the health care being
offered. Given these concerns about long-term life expectancy
calculations in the crisis standard of care context, denying or
providing lower priority for access to scarce critical care resources
based on a patient's disability impacting their long-term life
expectancy when such critical care resources would be provided to a
patient without such a disability may also constitute a violation of
Sec. 84.56(b)(2), insofar as it would represent a denial of medical
treatment for a separate symptom or condition that would be provided to
a similarly situated person without a disability. This may also violate
other provisions of the section 504 regulation, including the general
prohibitions against discrimination in Sec. 84.68 and the broad
prohibition against discrimination in medical treatment in Sec.
84.56(a).
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\45\ U.S. Dep't of Health & Human Servs., Off. for Civil Rts.,
FAQs for Healthcare Providers during the COVID-19 Public Health
Emergency: Federal Civil Rights Protections for Individuals with
Disabilities under section 504 and Section 1557 (Feb. 4, 2022),
<a href="https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html">https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html</a>.
\46\ See Sec. 84.68(b)(8); 28 CFR 35.130(b)(8) (DOJ title II
regulation).
\47\ See U.S. Dep't of Health & Human Servs., Off. for Civil
Rts., FAQs for Healthcare Providers during the COVID-19 Public
Health Emergency: Federal Civil Rights Protections for Individuals
with Disabilities under section 504 and Section 1557 (Feb. 4, 2022),
<a href="https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html">https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html</a> at question 7.
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Comments: Several commenters urged the Department to clarify that
crisis standards of care protocols that deny, limit, or give lower
priority to people with disabilities in accessing critical care
resources based on anticipated resource utilization could constitute a
violation of section 504 and Sec. 84.56.
Response: The Department agrees that such denials, limitations, or
lower priority for people with disabilities than other persons for
critical care resources based on resource-utilization can constitute a
violation of section 504 and Sec. 84.56. As discussed in the NPRM,
practices or protocols in which recipients deny medical resources based
on the projected length or scope of resources needed, and thus deny
care to certain individuals with a disability because they are
concerned that treating a patient with a disability may require more of
a particular resource than treating individuals without a disability,
may discriminate against persons with disabilities.\48\
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\48\ 88 FR 63401.
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Comments: Several commenters asked the Department to clarify that
reasonable modifications may be required to assessment tools used to
prioritize patients for access to critical care under crisis standards
of care and to provide examples of such modifications.
Response: The Department has carefully considered the comments
received and as discussed in the NPRM, recipients may be required to
make reasonable modifications to prognostic scoring tools used to
prioritize critical care resources under crisis standards of care, just
as this obligation exists outside of crisis standards of care contexts.
For instance, throughout the COVID-19 pandemic, many States and
hospitals indicated they planned to make use of the Sequential Organ
Failure Assessment (SOFA) to make judgments about short-term life
expectancy in the event that crisis standards of care were activated.
The SOFA is a composite instrument, incorporating scores from multiple
other instruments into a composite score that has been used within
crisis standards of care allocation to predict short-term life
expectancy. Among the component instruments of the SOFA is the Glasgow
Coma Scale (GCS). Application of the GCS, a tool designed to measure
the severity of acute brain injuries, may not yield a valid result
(i.e., it may not correspond to actual mortality risk) when applied to
patients with underlying disabilities that impact speech or motor
movement issues. The GCS assigns a more severe score to patients who
cannot articulate intelligible words or who cannot obey commands for
movement. However, many disabilities result in these same attributes--
such as autism and cerebral palsy--but do not contribute to short-term
mortality. As a result, the use of the SOFA with patients with such
underlying disabilities may lead to an unduly pessimistic prediction of
short-term survival, giving such patients lower priority in accessing
scarce critical care resources.
As the American Academy of Developmental Medicine and Dentistry
(AADMD) notes, ``in the field of developmental medicine, there are
patients who, at their natural baseline often cannot hear a command,
move their limbs or communicate verbally. Given the combination of
characteristics inherent in the population of people with intellectual
and developmental disabilities, it would be possible to use `objective'
data surrounding the SOFA score to predict a significantly higher
mortality risk than is really the case.'' \49\ Similar impacts may
exist for other types of disabilities and other prognostic scoring
tools, measures, diagnostic instruments, and
[[Page 40088]]
methodologies for assessment or the allocation of scarce medical
resources.
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\49\ Am. Acad. of Dev. Med. & Dentistry, People with
Intellectual and Developmental Disabilities and the Allocation of
Ventilators During the COVID-19 Pandemic (Apr. 2020), <a href="https://static1.squarespace.com/static/5cf7d27396d7760001307a44/t/5ecfb6fff13530766aeae51a/1590671105171/Ventilator+-+Policy+Statement+w+Addendum.pdf">https://static1.squarespace.com/static/5cf7d27396d7760001307a44/t/5ecfb6fff13530766aeae51a/1590671105171/Ventilator+-+Policy+Statement+w+Addendum.pdf</a>.
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The general requirement that recipients provide reasonable
modifications when necessary to avoid discrimination that appears in
proposed Sec. 84.68(b)(7) applies in circumstances of scarce
resources, just as it does elsewhere. Section 504 might, for example,
require reasonable modifications in the administration of assessment
tools such as the SOFA and the GCS (which may be used within a larger
scoring rubric for the allocation of scarce resources) to ensure that
the tools measure accurately what they are intended to measure in
people with disabilities. For example, a scoring tool may typically
assess the inability of a person to articulate words, but it would
likely be discriminatory to use that determination to indicate an
actual mortality risk when assessing a person with cerebral palsy
because that person's pre-existing speech impairments do not imply
mortality risk in the context of the acute care episode the person is
seeking care for. We also note that, in general, mortality risk
screening should be linked to the event that led to the acute care
episode rather than an individual's pre-existing disability.
Organ Transplantation
In the NPRM, the Department noted that organ transplant
discrimination against people with disabilities remains an ongoing
problem. OCR's investigative experience confirms ongoing concerns about
discrimination at various points in the transplant process. Medical
providers and transplant programs continue to refuse to evaluate
patients with disabilities who are otherwise qualified for transplant
eligibility and fail to place qualified patients on transplant waiting
lists because of exclusions and limitations for certain disabilities
that are not supported by objective evidence or that do not take into
account reasonable modifications in assessing an individual's ability
to manage postoperative care needs and other aspects of
transplantation. For example, in 2019, OCR resolved a case alleging
discrimination against an individual with Autism Spectrum Disorder, in
which the complainant alleged that a medical center deemed the patient
ineligible to be considered for evaluation for placement on a heart
transplant wait list because of the individual's diagnosis of Autism
Spectrum Disorder and anticipated difficulties managing postoperative
care. OCR worked with the recipient to enter a voluntary resolution
agreement and the medical facility agreed to reevaluate the
individual's eligibility for placement on the waiting list and consider
the services and supports the individual could access to manage
postoperative care.
Comments: Many commenters praised the Department for addressing
discrimination against people with disabilities in organ
transplantation and urged the Department to clarify that section 504
and Sec. 84.56 apply to the broad scope of the organ transplantation
process, including the provision of information that transplantation
was an option, referral to a transplant center, evaluation by the
transplant center for clinical eligibility for transplantation,
evaluation for ability to manage post-operative care needs,
prioritization for access to organ transplants, and other aspects of
organ transplantation. They also asked the Department to include
additional information and examples regarding the application of Sec.
84.56 to organ transplant discrimination and to respond to specific
inquiries.
Response: The Department agrees that organ transplant
discrimination against people with disabilities remains an ongoing
problem and that section 504 and Sec. 84.56 apply throughout the organ
transplantation process, including the provision of information,
referrals, evaluation, eligibility, prioritization and other aspects of
the transplantation process. We respond to inquiries and provide
further information on the application of Sec. 84.56, including
illustrative examples, throughout this subsection.
Comments: Many commenters highlighted discrimination against people
with disabilities, particularly people with developmental disabilities,
seeking access to organ transplantation on the grounds that they would
not be able to manage their post-operative care needs. These commenters
asked the Department to indicate that evaluation for suitability of
transplantation must be done taking into account modifications the
patient with a disability may use to manage their post-operative care
regimen, including both formal and informal supports. A commenter also
asked the Department to indicate that denying a person with a
developmental disability, such as intellectual disability or autism,
access to organ transplantation because the recipient believes the
person with a disability would not be able to maintain the strict
regimen necessary to avoid organ rejection would constitute a violation
of Sec. 84.56(b)(1), which prohibits denial of medical treatment based
on biases or stereotypes on the basis of a person's disability. Another
commenter described a patient with a disability being denied access to
transplantation due to concerns on the part of the transplant center
that their supporter also had a disability and would not be able to
provide the patient with adequate assistance after their operation due
to the supporter's disability.
Response: The Department agrees that denying a person with a
developmental disability access to organ transplantation because the
recipient believes the person with a disability would not be able to
manage their post-operative care needs may violate Sec. 84.56(b) if
this assessment did not take into account modifications the patient may
make use of, such as reliance on formal and informal care and other
supports. Such a denial could constitute a violation of Sec.
84.56(b)(1), if motivated based on biases or stereotypes about the
patient's disability. However, even where this denial is not the result
of biases or stereotypes regarding a patient's disability, it may be
prohibited by other provisions of this rule. For example, a transplant
center that conducts an individualized evaluation of a patient with a
developmental disability and concludes they would be unable to manage
their post-operative care needs independently may not have done so as a
result of biases or stereotypes. However, by not considering within
their evaluation the patient's ability to manage their post-operative
care needs with support from family, service-providers or others in the
patient's circle of support, a recipient may violate Sec. 84.68(b)(7),
which requires reasonable modifications to policies, practices and
procedures for people with disabilities, and Sec. 84.56(b)(2), as
evaluating whether a person with a disability is qualified to receive a
transplant and/or similarly situated to a person without a disability
who would receive an organ transplantation must be done taking into
account the reasonable modifications the patient with a disability may
utilize in order to meet qualification standards.
Clinical Research
Clinical research participation can offer considerable benefit to
both the individuals participating and society at large. In addition to
the intangible benefits of advancing scientific discovery and
contributing to the development of potential medical interventions,
those participating in clinical research are often able to obtain
access to diagnostic, preventative, or therapeutic interventions and
treatments that would not otherwise be available to them. The
unnecessary exclusion of people with disabilities from clinical
research harms those who
[[Page 40089]]
are denied the direct benefits of research participation. It also
threatens the generalizability of research findings and potentially the
reach of subsequent medical innovations for those groups who are
excluded.
Recent research has documented that people with disabilities face
systemic and unnecessary exclusion from clinical research.\50\ Although
study exclusions and other restrictions in eligibility criteria can be
justifiable in appropriate cases based on the nature of the clinical
research being conducted, they can also be the result of a failure to
take into account the availability of reasonable modifications to a
study protocol that might permit the participation of people with
disabilities. It also may be the result of overly narrow eligibility
criteria rooted in stereotypes, bias, or misunderstandings of the
capabilities of people with specific disabilities. Investigators may
have valid reasons for excluding people whose disabilities are
medically incompatible with the study being conducted. When evaluating
potential study participants on an individualized basis, clinical
judgment may be necessary on the part of the investigator to assess the
appropriateness of study participation. However, it is important that
study eligibility criteria be written in a way that does not
unnecessarily screen out people with disabilities whose research
participation would not alter the intended purpose of the program of
clinical research being undertaken.
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\50\ Willyanne DeCormier Plosky et al., Excluding People with
Disabilities from Clinical Research: Eligibility Criteria Lack
Clarity and Justification, 41 Health Aff. 10 (Jan. 2022). <a href="https://doi.org/10.1377/hlthaff.2022.00520">https://doi.org/10.1377/hlthaff.2022.00520</a>; Katie McDonald et al.,
Eligibility Criteria in NIH-funded Clinical Trials: Can Adults with
Intellectual Disability Get In? 15 Disability & Health (2022),
<a href="https://doi.org/10.1016/j.dhjo.2022.101368">https://doi.org/10.1016/j.dhjo.2022.101368</a>.
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Similarly, overly narrow eligibility criteria that unnecessarily
screen out people with disabilities may be motivated by concerns
regarding the ability of potential study participants with disabilities
to perform research-related tasks that can be reasonably modified, such
as filling out tests or responding to instructions from research
personnel, or by the failure to take into account the recipient's
obligation to provide for effective communication or make reasonable
modifications for people with disabilities.
Many commenters appreciated the specific application of section
504, including Sec. 84.56, to clinical research activities in the
proposed rule, and asked the Department to provide further examples and
respond to queries regarding the application of section 504, including
but not limited to Sec. 84.56, to clinical research. Some commenters
provided specific examples of discrimination on the basis of disability
in clinical trials, including on the basis of leukemia, multiple
sclerosis, HIV, obesity, muscular dystrophy and other neuromuscular
diseases as well as other diagnoses. Many examples focused on the
negative consequences of being denied access to clinical research on
those people with disabilities turned away.
Other commenters focused on the adverse implications on society as
a whole of excluding people with disabilities from clinical research.
For instance, some commenters noted the impact of clinical research in
value assessment activities that inform payer activities regarding
utilization management and the coverage of particular medical
interventions for specific patient populations. (We further discuss the
intersection of clinical trial exclusions on the basis of disability
and utilization management decisions by payers elsewhere within this
subsection.) Others noted that the exclusion of people with
disabilities from clinical research may contribute to a lack of
information on differences in the efficacy, effectiveness, and side
effects profiles of medical interventions being studied.
Response: As indicated elsewhere in this section, the Department
considers Sec. 84.56 to apply to clinical research activities of
recipients. The provision of Sec. 84.56 that is most likely to be
relevant to clinical research is Sec. 84.56(b)(2), which prohibits
denying or limiting treatment for a separately diagnosable symptom or
medical condition if it would be offered to a similarly situated
individual without an underlying disability. In addition, section 504
regulations include other provisions that apply to clinical research
activities. For example, Sec. 84.68(b)(8) prohibits imposing or
applying eligibility criteria that screen out or tend to screen out
individuals with disabilities or classes of individuals with
disabilities from ``fully and equally'' enjoying any program or
activity, unless the criteria can be shown to be necessary for the
provision of the program or activity being offered. However, the
Department notes that application of each of these provisions is fact-
dependent. As the Department noted within the NPRM, the use of
eligibility criteria that screen out or tend to screen out people with
disabilities from clinical research can constitute a violation of this
provision.
For example, assume that a researcher employed by an entity
receiving Federal financial assistance develops a protocol for use in
clinical research evaluating a new intervention for diabetes care. The
researcher articulates inclusion and exclusion criteria for the study
and includes a requirement that study participants must not have a
visual impairment, based on the determination that patients with
diabetes-related visual impairments would be medically contraindicated
from making use of the intervention. Potential study participants with
any form of visual impairment are excluded, even if their blindness is
not indicative of a stage of diabetes disease progression that would
preclude treatment effectiveness. Prohibiting a qualified individual
with a disability from participating in a clinical research program
based on a broad-based categorical judgments related to a disability
likely violates section 504, where such categorical exclusion criteria
are not necessary for the implementation of the study, as doing so
screens out individuals with disabilities from participating in a
program of clinical research and is not necessary for the operation of
the research program. In contrast, a researcher in similar
circumstances who excludes only patients with diabetes-related visual
impairments that are likely to impact eligibility for the study because
of the clinical appropriateness of receiving the treatment being
studied is not likely to be unnecessarily screening out individuals
with disabilities, as excluded patients are only those who are
medically contraindicated for the treatment. In addition, the
obligation articulated in Sec. 84.68(b)(7) to make reasonable
modifications to policies, practices, or procedures when necessary to
avoid discrimination unless the modification would fundamentally alter
the nature of the program or activity at issue also applies to clinical
research.
In some instances, excluding people with disabilities from clinical
research may implicate further provisions of the section 504
regulations. For example, a researcher who prohibits patients with
cognitive disabilities from participating in a research study regarding
cancer treatment based on a belief that they would not be able to
provide informed consent could violate Sec. 84.56(b)(1)(i), as it
constitutes a denial of medical treatment to a qualified individual
with a disability based on stereotypes regarding a patient's
disability, Sec. 84.56(b)(2), as it constitutes a denial of treatment
for a separate symptom or condition that would be offered to a
similarly situated person without a disability, and Sec. 84.68(b)(7)
as concerns about informed consent could be
[[Page 40090]]
addressed through a reasonable modification permitting the prospective
study participant with an intellectual disability to use supported
decision-making by bringing a friend or family member to help study
staff explain the study risks and benefits to them.
Comments: One comment from an academic research center focused on
clinical trials requested the Department replace the phrase ``exclusion
criteria'' for ``eligibility criteria'' as the exclusion of people with
disabilities from clinical research may take place both through
explicit exclusion criteria and through overly narrow inclusion
criteria or other components of a study protocol that result in the
unnecessary exclusion of people with disabilities. They ask the
Department to clarify that the obligations of section 504 apply to the
broad scope of a study protocol and clinical research activities, not
just exclusion criteria. Another commenter noted that people with
disabilities are often excluded from clinical trials due to the use of
clinical end points that are consistent with prior research studies but
not necessary for the program of clinical research currently being
undertaken.
Response: The Department agrees that the unjustified exclusion of
people with disabilities from clinical research can take place through
explicit exclusion criteria, overly narrow inclusion criteria, and
through other aspects of a study protocol or clinical research
activities that unnecessarily screen out people with disabilities. We
have revised the preamble language throughout to clarify this point and
include other information on potential ways in which section 504
applies to clinical research.
Comment: Another commenter requested that the Department require
organizations conducting clinical research and the Food and Drug
Administration (FDA) show the exclusion of individuals with
disabilities within the study population is necessary for the success
of the study and not simply a continuation of a previous practice
chosen for simplicity.
Response: As indicated above, section 504 regulations require
eligibility criteria to not screen out or tend to screen out people
with disabilities from a clinical research program unless the criteria
can be shown to be necessary for the provision of the program or
activity being offered. Section 84.56 operationalizes this through
multiple specific prohibitions, which we have articulated above. If
recipients specifically exclude populations of persons with
disabilities from their clinical research, they should articulate clear
rationales for those populations of people with disabilities who are
excluded to ensure that such exclusions are necessary for the provision
of the program or activity of clinical research being conducted.
Comment: A commenter described a scenario in which a patient was
denied access to a clinical trial for a mental health treatment they
were otherwise qualified for because the program required periodic
imaging and the imaging equipment affiliated with the program had a low
weight capacity that could not accommodate the patient's obesity. They
sought and were denied a reasonable modification of using other imaging
equipment available to the medical center that was not typically
utilized in the clinical trial. They asked how section 504 would apply
to this situation.
Response: Whether the scenario described by the commenter
constitutes a violation of section 504 is fact-dependent.\51\ Sections
of the rule that would need to be considered would include Sec.
84.56(b)(2), as the patient was seeking treatment for a separate
medical symptom or condition and was denied it when it would have been
provided to a similarly situated patient without a disability, and
Sec. 84.68(b)(7), which requires reasonable modifications for people
with disabilities. Recipients conducting clinical trials have an
obligation to make reasonable modifications for people with
disabilities, including using available accessible equipment elsewhere
within a facility, unless they would constitute a fundamental
alteration of the program or activity being offered. As indicated
within the NPRM, the exclusion of people with disabilities from
clinical research may also constitute a violation of Sec. 84.68(b)(8),
which prohibits imposing or applying eligibility criteria that screen
out or tend to screen out individuals with disabilities or classes of
individuals with disabilities from ``fully and equally'' enjoying any
program or activity, unless the criteria can be shown to be necessary
for the provision of the program or activity being offered.
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\51\ We encourage any person who believes they or another party
has been discriminated against on the basis of race, color, national
origin, sex, age, or disability, to visit the OCR complaint portal
to file a complaint online at: <a href="https://www.hhs.gov/civil-rights/filing-a-complaint/index.html">https://www.hhs.gov/civil-rights/filing-a-complaint/index.html</a>.
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Comment: Some commenters asked the Department to clarify that
unnecessarily excluding people with disabilities from clinical research
not related to their disability may constitute discrimination.
Response: The Department agrees that section 504 applies to
clinical research both relating to a patient's disability and not
related to a patient's disability.
Comment: Several commenters asked OCR to consider issuing sub-
regulatory guidance in collaboration with other parts of the Federal
Government, including the National Institutes of Health and the FDA,
regarding the application of section 504 to clinical research
activities.
Response: The Department will consider issuing guidance and
providing technical assistance regarding the application of section 504
to clinical research in the future.
Examples Regarding Sec. 84.56(b)(1)
Many commenters requested the Department add additional prohibited
rationales for discrimination to the regulatory text of Sec.
84.56(b)(1), which provides a non-exhaustive list of prohibited
rationales for denying or limiting medical treatment to a qualified
individual with a disability and applies broadly (regardless of whether
a patient is seeking treatment for their underlying disability or for a
separate symptom or condition). The Department responds to these
requests and for other clarifications regarding the application of
Sec. 84.56(b)(1) in this subsection.
Comment: One commenter requested that the Department add to Sec.
84.56(b)(1) language prohibiting denying or limiting medical treatment
to a qualified individual with a disability based on a belief that
providing care for a patient with a disability would constitute a
suboptimal use of recipient resources, unless the same judgment would
be made about a patient who did not have a disability.
Response: The Department agrees that a denial or limitation of
treatment based on a belief that providing care for a patient with a
disability would constitute a suboptimal use of recipient resources,
where the same judgment would not be made about a similarly situated
patient who did not have a disability, would likely be prohibited
discrimination under Sec. 84.56. However, the Department believes that
this conduct is already addressed under Sec. 84.56(a) and other
sections of Sec. 84.56. Where the treatment being sought is for a
separate medical symptom or condition, it is prohibited under Sec.
84.56(b)(2). Such action would likely also be prohibited under Sec.
84.56(b)(1)(iii), which prohibits discrimination based on a belief that
the life of a person with a disability has lesser value than the life
of a person without a disability, or that life with a disability is not
worth living.
[[Page 40091]]
Comment: Several commenters requested that the Department clarify
that Sec. 84.56(b)(1)(i) extends to the denial or limitation of
medical treatment based on biases and stereotypes regarding particular
medical treatments for a disability because such biases and stereotypes
originate with beliefs about a patient's disability.
Response: The Department agrees that biases and stereotypes
regarding particular medical treatments can constitute biases and
stereotypes regarding the disability of the patients that receive them.
For example, biases and stereotypes regarding antiretroviral therapy
may constitute discrimination against persons with HIV. Similarly,
biases and stereotypes regarding Medication Assisted Treatment for
Opioid Use Disorders could constitute discrimination against persons
with Opioid Use Disorders.
Comment: Several commenters requested that the Department add to
the regulatory text of Sec. 84.56(b)(1) language prohibiting denying
or limiting medical treatment to a qualified individual with a
disability based on whether a patient has an advance directive.
Response: Where a recipient denies medical treatment to persons
with disabilities because they do not have an advance directive, but
does not do so for persons without disabilities who do not have an
advance directive, such a denial or limitation would likely violate the
general prohibition on discrimination on the basis of disability in
Sec. 84.56(a) and may also constitute prohibited discrimination under
Sec. 84.56(c)(2)(ii), which prohibits discrimination against
[…truncated; see source link]Indexed from Federal Register on May 9, 2024.
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