Proposed Rule2023-19149
Discrimination on the Basis of Disability in Health and Human Service Programs or Activities
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Published
September 14, 2023
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 proposes to update and amend its section 504 regulation. The proposed rule would add new provisions that clarify existing requirements under section 504 prohibiting recipients of financial assistance from the Department (recipients) from discriminating on the basis of disability in their programs and activities, including in health care, child welfare, and other human services. The proposed rule includes new requirements prohibiting discrimination in the areas of medical treatment; the use of value assessments; web, mobile, and kiosk accessibility; and requirements for accessible medical equipment, so that persons with disabilities have an opportunity to participate in or benefit from health care programs and activities that is equal to the opportunity afforded others. It also adds a section on child welfare to expand on and clarify the obligation to provide nondiscriminatory child welfare services. The proposed rule would also update the definition of disability and other provisions to ensure consistency with statutory amendments to the Rehabilitation Act, enactment of the Americans with Disabilities Act and the Americans with Disabilities Amendments Act of 2008, the Affordable Care Act, as well as Supreme Court and other significant court cases. It also further clarifies the obligation to provide services in the most integrated setting. Finally, the proposed rule would make other clarifying edits, including updating outdated terminology and references.
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[Federal Register Volume 88, Number 177 (Thursday, September 14, 2023)]
[Proposed Rules]
[Pages 63392-63512]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19149]
[[Page 63391]]
Vol. 88
Thursday,
No. 177
September 14, 2023
Part III
Department of Health and Human Services
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45 CFR Part 84
Discrimination on the Basis of Disability in Health and Human Service
Programs or Activities; Proposed Rule
Federal Register / Vol. 88, No. 177 / Thursday, September 14, 2023 /
Proposed Rules
[[Page 63392]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 84
RIN 0945-AA15
Discrimination on the Basis of Disability in Health and Human
Service Programs or Activities
AGENCY: Office for Civil Rights (OCR), Office of the Secretary, HHS.
ACTION: Proposed 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 proposes to update and amend its
section 504 regulation. The proposed rule would add new provisions that
clarify existing requirements under section 504 prohibiting recipients
of financial assistance from the Department (recipients) from
discriminating on the basis of disability in their programs and
activities, including in health care, child welfare, and other human
services. The proposed rule includes new requirements prohibiting
discrimination in the areas of medical treatment; the use of value
assessments; web, mobile, and kiosk accessibility; and requirements for
accessible medical equipment, so that persons with disabilities have an
opportunity to participate in or benefit from health care programs and
activities that is equal to the opportunity afforded others. It also
adds a section on child welfare to expand on and clarify the obligation
to provide nondiscriminatory child welfare services. The proposed rule
would also update the definition of disability and other provisions to
ensure consistency with statutory amendments to the Rehabilitation Act,
enactment of the Americans with Disabilities Act and the Americans with
Disabilities Amendments Act of 2008, the Affordable Care Act, as well
as Supreme Court and other significant court cases. It also further
clarifies the obligation to provide services in the most integrated
setting. Finally, the proposed rule would make other clarifying edits,
including updating outdated terminology and references.
DATES:
Comments: Submit comments on or before November 13, 2023.
Meeting: Pursuant to Executive Order 13175, Consultation and
Coordination with Indian Tribal Governments, the Department of Health
and Human Services' Tribal Consultation Policy, and the Department's
Plan for Implementing Executive Order 13175, the Office for Civil
Rights solicits input by tribal officials as we develop the
implementing regulations for section 504 of the Rehabilitation Act of
1973 at 45 CFR part 84. The Tribal consultation meeting will be held on
October 6, 2023 from 2 p.m. to 4 p.m. Eastern Time.
ADDRESSES:
Meeting: To participate in the Tribal consultation, you must
register in advance at <a href="https://www.zoomgov.com/meeting/register/vJIsceGqpzsjEwi5AQ8pvdIholm7Xp4hwLs">https://www.zoomgov.com/meeting/register/vJIsceGqpzsjEwi5AQ8pvdIholm7Xp4hwLs</a>.
Comments: You may submit comments to this proposed rule, identified
by RIN 0945-AA15, by any of the following methods. Please do not submit
duplicate comments.
Federal eRulemaking Portal. You may submit electronic comments at
<a href="http://www.regulations.gov">http://www.regulations.gov</a> by searching for the Docket ID number HHS-
OCR-2023-0013. Follow the instructions at <a href="http://www.regulations.gov">http://www.regulations.gov</a>
online for submitting comments through this method.
Regular, Express, or Overnight Mail: You may mail comments to U.S.
Department of Health and Human Services, Office for Civil Rights,
Attention: Disability NPRM, RIN 0945-AA15, Hubert H. Humphrey Building,
Room 509F, 200 Independence Avenue SW, Washington, DC 20201.
All comments sent by the methods and received or officially
postmarked by the due date specified above will be posted without
change to content to <a href="http://www.regulations.gov">http://www.regulations.gov</a>, including any personal
information provided, and such posting may occur before or after the
closing of the comment period.
We will consider all comments received or officially postmarked by
the date and time specified in the DATES section above, but, because of
the large number of public comments we normally receive on Federal
Register documents, we are not able to provide individual
acknowledgements of receipt.
Please allow sufficient time for mailed comments to be timely
received in the event of delivery or security delays. Electronic
comments with attachments should be in Microsoft Word or Portable
Document Format (PDF).
Please note that comments submitted by fax or email, and those
submitted or postmarked after the comment period, will not be accepted.
Docket: For complete access to background documents or posted
comments, go to <a href="http://www.regulations.gov">http://www.regulations.gov</a> and search for Docket ID
number HHS-OCR-2023-0013.
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#390c090d7951514a175e564f"><span class="__cf_email__" data-cfemail="facfcaceba929289d49d958c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Purpose and Relevant Law
B. Summary of the Proposed Rule
II. Reasons for the Proposed Rulemaking
III. Nondiscrimination in Programs and Activities
A. New Provisions Addressing Discrimination on the Basis of
Disability Under Section 504
Medical Treatment (Sec. 84.56)
Value Assessment Methods (Sec. 84.57)
Children, Parents, Caregivers, Foster Parents, and Prospective
Parents in the Child Welfare System (Sec. 84.60)
Subpart I: Web, Mobile, and Kiosk Accessibility (Sec. Sec.
80.82-80.88)
Subpart J: Accessible Medical Equipment (Sec. Sec. 84.90-84.94)
B. Revised Provisions Addressing Discrimination and Ensuring
Consistency With Statutory Changes, Supreme Court, and Other Case
Law
Purpose and Broad Coverage (Sec. 84.1): Revisions to Subpart A
Application (Sec. 84.2): Revisions to Subpart A
Relationship to Other Laws (Sec. 84.3): Revisions to Subpart A
Definition of Disability (Sec. 84.4): Revisions to Subpart A
Notice (Sec. 84.8): Revisions to Subpart A
Definitions (Sec. 84.10): Revisions to Subpart A
Employment Practices (Sec. 84.16): Revisions to Subpart B
Program Accessibility (Sec. Sec. 84.21-84.23): Revisions to
Subpart C
Childcare, Preschool, Elementary and Secondary, and Adult
Education (Sec. Sec. 84.31, 84.38): Revisions to Subpart D
Health, Welfare, and Social Services (Sec. Sec. 84.51-84.55):
Revisions to Subpart F
Subpart G: General Requirements
General Prohibitions Against Discrimination (Sec. 84.68)
Illegal Use of Drugs (Sec. 84.69)
Maintenance of Accessible Features (Sec. 84.70)
Retaliation or Coercion (Sec. 84.71)
Personal Services and Devices (Sec. 84.72)
Service Animals (Sec. 84.73)
Mobility Devices (Sec. 84.74)
Direct Threat (Sec. 84.75)
Integration (Sec. 84.76)
Subpart H: Communications (Sec. Sec. 84.77-84.81)
Subpart K: Procedures (Sec. 84.98)
IV. Executive Order 12866 and Related Executive Orders on Regulatory
Review
Regulatory Impact Analysis Summary
Regulatory Flexibility Act--Initial Small Entity Analysis
[[Page 63393]]
Executive Order 13132: Federalism
Paperwork Reduction Act
National Technology Transfer and Advancement Act of 1995
Executive Order 12250 on Leadership and Coordination of
Nondiscrimination Laws
V. Effective Date
VI. Request for Comment
I. Background
A. Purpose and Relevant Law
Section 504 prohibits discrimination on the basis of disability in
programs and activities \1\ that receive Federal financial assistance
as well as in programs and activities conducted by any Federal
agency.\2\ Section 504 provides:
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\1\ The statutory text of section 504 explains that ``program or
activity'' means ``all of the operations of'' an agency. 29 U.S.C.
794(b)(1)(A). The term ``programs and activities'' is therefore
intended to cover the same types of operations that are covered
under title II of the Americans with Disabilities Act (ADA).
\2\ 29 U.S.C. 794.
No otherwise qualified individual with a disability in the
United States, as defined in Section 705(20) of this title, shall,
solely by reason of her or his disability, be excluded from the
participation in, be denied the benefits of, or be subjected to
discrimination under any program or activity receiving Federal
financial assistance or under any program or activity conducted by
any Executive agency or by the United States Post Office.\3\
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\3\ Id.
The Office for Civil Rights (OCR) in HHS enforces section 504 as
well as two 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.\4\ OCR also enforces section 1557
(section 1557) of the Patient Protection and Affordable Care Act
(ACA),\5\ 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
contract 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.\6\
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\4\ 42 U.S.C. 12132 (``. . . no qualified individual with a
disability shall, by reason of such disability, be excluded from
participation in or be denied the benefits of services, programs, or
activities of a public entity, or be subjected to discrimination by
any such entity''). The ADA regulations generally designate HHS as
the agency with responsibility for investigating complaints of
discrimination in ``programs, services, and regulatory activities
relating to the provision of health care and social services.'' 28
CFR 35.190(b)(3). With respect to employment, the standards
contained in title I of the ADA apply to determinations of
employment discrimination under section 504. Title I of the ADA
provides, ``No covered entity shall discriminate against a qualified
individual on the basis of disability in regard to job application
procedures, the hiring, advancement, or discharge of employees,
employee compensation, job training, and other terms, conditions,
and privileges of employment.'' 42 U.S.C. 12112. Title II entities
are also obligated to fulfill the ADA's title I requirements in
their capacity as employers, which are distinct from their
obligations under this rule.
\5\ 42 U.S.C. 18116.
\6\ In its Notice of Proposed Rulemaking on regulations
implementing Section 1557 of the Affordable Care Act, 45 CFR pt. 92,
the Department has proposed to revise its interpretation that
``Federal financial assistance'' does not include Medicare Part B,
and to make conforming necessary amendments to the appendices of
regulations implementing both Title VI of the Civil Rights Act and
section 504. 87 FR 47824, 47828 (Aug. 4, 2022). Those proposed
changes are not separately addressed in this rule.
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Congress passed the Rehabilitation Act in 1973, and what was then
the U.S. Department of Health, Education, and Welfare (HEW) issued
regulations to implement section 504 in 1977.\7\ In the more than 40
years since, 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), the ACA, and Supreme Court and other significant
court cases. It is crucial that section 504 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 that clarity, the Department proposes amendments to its
existing section 504 regulation on nondiscrimination obligations for
recipients of Federal financial assistance (part 84).
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\7\ In 1980, Congress reorganized HEW into several Federal
agencies including the Department of Health and Human Services and
the Department of Education. The existing section 504 regulations of
HEW continued in place with HHS.
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In addition, since section 504 also covers programs and activities
conducted by the Department, the Department intends to publish a
separate rulemaking to update its existing federally conducted
regulation, which has not been amended since it was enacted in 1998
(part 85).\8\
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\8\ 45 CFR pt. 85.
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B. Summary of the Proposed Rule
The Department proposes to amend its existing regulation
implementing section 504 for federally assisted programs and activities
to address the obligations of recipients of Federal financial
assistance to comply with section 504 across a variety of contexts. The
proposed rule clarifies the application of section 504 to several areas
not explicitly addressed through the existing regulation, including
medical treatment decisions; the use of value assessments; web, mobile,
and kiosk accessibility; and accessible medical equipment. The proposed
rule also expands on and clarifies the requirements in the current
regulation applicable to federally funded child welfare programs and
activities.
In addition, the Department proposes to update pertinent provisions
throughout the rule to promote consistency with title II of the ADA and
the corresponding U.S. Department of Justice (DOJ) ADA regulations. The
proposed rule will add the following new sections to the section 504
regulations that track the ADA regulations: definition of
``disability,'' notice, maintenance of accessible features, retaliation
and coercion, personal devices and services, service animals, mobility
devices, and communications. The proposed rule also contains the
following sections that are similar to the ADA regulations: purpose and
broad coverage, definitions, general prohibitions against
discrimination, program accessibility, illegal use of drugs, direct
threat, and integration. The proposed rule will also provide more
detailed standards on the obligation to provide programs and activities
in the most integrated setting appropriate and will make non-
substantive clarifying edits, including updating outdated terminology
and references and omitting obsolete regulatory sections.
Section 504 and the ADA are generally understood by courts to
impose similar requirements. Moreover, the vast majority of recipients
have been covered by either title II of the ADA (State and local
government entities) or title III of the ADA (certain private entities)
since 1991. Therefore, the rule proposes to adopt ADA language in
appropriate circumstances. Doing so will allow for greater public
understanding and ease of compliance by regulated entities.
II. Reasons for the Proposed Rulemaking
The Department is issuing this proposed rule to address
discrimination on the basis of disability by recipients of HHS
financial assistance.\9\ The
[[Page 63394]]
proposed regulation offers clear and specific requirements to help
recipients and beneficiaries better understand their rights and
responsibilities under section 504. In the years since HEW first
promulgated its section 504 regulation, it has rarely been amended,
with the most recent amendment occurring in 2005.\10\ The proposed rule
addresses developments in statutory and case law regarding disability
discrimination. To promote voluntary compliance with the law, we
provide further clarity and elaboration to the legal standards.
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\9\ 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.
\10\ 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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Furthermore, the proposed rule is consistent with the goals and
objectives of several recent Executive Orders that address equitable
access to benefits and services for underserved populations. As
detailed below, people with disabilities have historically been
underserved by, denied equitable access to, or excluded from health
programs and activities. Executive Order 14035 (Advancing Diversity,
Equity, Inclusion, and Accessibility Across the Federal Government) and
Executive Order 13985 (Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government) explicitly
describe people with disabilities as an underserved community and
priority population for Federal policy intervention. The rulemaking is
also consistent with Executive Order 14009 (Strengthening Medicaid and
the Affordable Care Act), which requires agencies with authorities and
responsibilities related to Medicaid and the ACA to review existing
regulations to ensure they promote equitable access to high-quality
health care accessible and affordable for every American, including
reviewing policies or practices that may undermine protections for
people with pre-existing conditions, including complications related to
COVID-19, under the ACA. Finally, this rulemaking is consistent with
Executive Order 14070 (Continuing to Strengthen Americans' Access to
Affordable, Quality Health Coverage), which directs the Department to
examine policies or practices that strengthen benefits and improve
access to health care providers.
People with disabilities are often excluded from health programs
and activities and denied an equal opportunity to participate in and
benefit from quality health care.\11\ That discrimination contributes
to significant health disparities and poorer health outcomes than
persons with disabilities would experience absent the
discrimination.\12\
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\11\ See, e.g., Elizabeth A. Courtney-Long et al., Socioeconomic
Factors at the Intersection of Race and Ethnicity Influencing Health
Risks for People with Disabilities, 4 J. of Racial and Ethnic Health
Disparities 213 (2017), <a href="https://doi.org/10.1007/s40615-016-0220-5">https://doi.org/10.1007/s40615-016-0220-5</a>;
Susan Havercamp et al., National Health Surveillance of Adults with
Disabilities, Adults with Intellectual and Developmental
Disabilities, and Adults with No Disabilities, 8 Disability & Health
J. 165 (2015), <a href="https://doi.org/10.1016/j.dhjo.2014.11.002">https://doi.org/10.1016/j.dhjo.2014.11.002</a>; Lisa I.
Iezzoni et al., Have Almost Fifty Years of Disability Civil Rights
Laws Achieved Equitable Care?, 41 Health Affairs 1371 (2022),
<a href="https://doi.org/10.1377/hlthaff.2022.00413">https://doi.org/10.1377/hlthaff.2022.00413</a>; Tara Lagu et al., `I Am
Not The Doctor For You': Physicians' Attitudes About Caring For
People With Disabilities, 41 Health Affairs 1387 (2022), <a href="https://doi.org/10.1377/hlthaff.2022.00475">https://doi.org/10.1377/hlthaff.2022.00475</a>; Monika Mitra et al., (2022)
Advancing Health Equity and Reducing Health Disparities for People
with Disabilities in the United States, 41 Health Affairs 1379
(2022), <a href="https://doi.org/10.1377/hlthaff.2022.00499">https://doi.org/10.1377/hlthaff.2022.00499</a>. Nat'l Council on
Disability, Health Equity Framework for People With Disabilities
(2022), <a href="https://www.ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf">https://www.ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf</a>; Nat'l Council on Disability, The
Current State of Health Care for People with Disabilities (2009).
\12\ See, e.g., Nat'l Council on Disability, Bioethics and
Disability Report Series (2019), <a href="https://ncd.gov/publications/2019/bioethics-report-series">https://ncd.gov/publications/2019/bioethics-report-series</a>; Tara Lagu et al., The Axes of Access--
Improving Care Quality for Patients with Disabilities, 370 New Eng.
J. Med. 1847 (May 2014); Tara Lagu et al., Ensuring Access to Health
Care for Patients with Disabilities, 175 JAMA Internal Med. 157
(Dec. 2014); Tim Gilmer, Equal Health Care: If Not Now, When?, New
Mobility (July 2013), <a href="http://www.newmobility.com/equal-health-care-if-not-now-when">http://www.newmobility.com/equal-health-care-if-not-now-when</a>; Gloria L. Krahn et al., Persons with Disabilities
as an Unrecognized Health Disparity Population, 105 Am. J. of Pub.
Health (Suppl 2) S198 (S198-S206) (2015); Kristi L. Kirschner et
al., Structural Impairments that Limit Access to Health Care for
Patients with Disabilities, 297 JAMA 1121 (2007).
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The National Council on Disability (NCD), an independent Federal
agency, has observed that ``[o]ne of the hallmarks of societal
attitudes toward disabilities has been a tendency of people without
disabilities to overestimate the negative aspects and underestimate the
positive features of the lives of those who have disabilities.'' \13\
Research in the field of health care supports this assertion.\14\ One
recent study demonstrates that large proportions of practicing U.S.
physicians appear to hold biased or stigmatized perceptions of people
with disabilities.\15\ The study found that many physicians perceive
that people with disabilities experience a lower quality of life
because of their disabilities--even though most individuals with
disabilities report that they experience an excellent or good quality
of life. Furthermore, only 40.7% of physicians surveyed were confident
of their ability to provide the same quality of care to patients with
disabilities and only 56.5% strongly agreed that they welcome patients
with disabilities into their practices.\16\ Flawed perceptions,
stereotypes, and biases about individuals with disabilities can lead to
prohibited discrimination.\17\
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\13\ Nat'l Council on Disability, Assisted Suicide: A Disability
Perspective (Mar. 24, 1997), <a href="https://ncd.gov/publications/1997/03241997">https://ncd.gov/publications/1997/03241997</a>.
\14\ See, e.g., Laura VanPuymbrouck, et al., Explicit and
Implicit Disability Attitudes of Healthcare Providers,
Rehabilitation Psych., 65(2) 2020, at 101-112; Stefanie Ames et al.,
Perceived Disability-Based Discrimination in Health Care for
Children With Medical Complexity, Pediatrics, 152(1) 2023, <a href="https://doi.org/10.1542/peds.2022-060975">https://doi.org/10.1542/peds.2022-060975</a>.
\15\ See Tara Lagu et al., `I Am not the Doctor For You':
Physicians' Attitudes about Caring for People with Disabilities, 41
Health Affairs 1387 (2022), <a href="https://doi.org/10.1377/hlthaff.2022.00475">https://doi.org/10.1377/hlthaff.2022.00475</a>; Laura VanPuymbrouck et al., Explicit and
Implicit Disability Attitudes of Healthcare Providers,
Rehabilitation Psych., 65(2) 2020, at 101-112, <a href="https://doi.org/10.1037/rep0000317">https://doi.org/10.1037/rep0000317</a>.
\16\ Lisa I. Iezzoni et al., Physicians' Perceptions of People
with Disability and their Health Care, 40 Health Aff. 297 (Feb.
2021), <a href="https://pubmed.ncbi.nlm.nih.gov/33523739/">https://pubmed.ncbi.nlm.nih.gov/33523739/</a> (citing GL Albrecht
et al., The Disability Paradox: High Quality of Life Against All
Odds, 48 Soc. Sci. Med., 977 (1999)).
\17\ See, e.g., Lesley v. Chie, 250 F.3d 47, 55 (1st Cir. 1985)
(Physician's decision could be ``discriminatory on its face, because
it rested on stereotypes of the disabled rather than an
individualized inquiry into the patient's condition'').
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These issues are not limited to health care. For example, the NCD
2012 report, ``Rocking the Cradle: Ensuring the Rights of Parents with
Disabilities and Their Children,'' included research and accounts of
parents who had been treated unfairly because of their disabilities,
documenting persistent and systemic discrimination against parents with
disabilities whose children were involved with the child welfare
system.\18\ The Department is issuing this proposed regulation to offer
clear and specific requirements to help recipients better understand
their obligations under the law and to help individuals with
disabilities better understand their rights. The Department believes
this added clarity and transparency will support recipients in
providing programs and activities free of discrimination on the basis
of disability.
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\18\ Nat'l Council on Disability, Rocking the Cradle: Ensuring
the Rights of Parents with Disabilities and their Children (2012),
<a href="https://www.ncd.gov/sites/default/files/Documents/NCD_Parenting_508_0.pdf">https://www.ncd.gov/sites/default/files/Documents/NCD_Parenting_508_0.pdf</a>.
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This preamble will address first the new provisions being added to
the existing section 504 rule (Section III(A) in the Table of Contents
above)--medical treatment; value assessment; child welfare; web,
mobile, and kiosk accessibility; and accessible medical equipment--and
then will address the updated provisions (Section III(B) in the Table
of Contents). However, the text of the rule itself does not start with
the
[[Page 63395]]
new provisions but, instead, follows in numerical order. This
explanation is being provided so that a reader can understand how the
order of this preamble corresponds to the text of the regulation.
Throughout this NPRM, the terms ``individual with a disability,''
``people with disabilities,'' and ``person with a disability'' are used
interchangeably. No substantive difference is intended.
III. Nondiscrimination in Programs and Activities
A. New Provisions Addressing Discrimination on the Basis of Disability
Under Section 504 Sec. 84.56 Medical Treatment
The Department funds a wide array of programs and activities in
which recipients make decisions regarding medical treatment. Medical
literature, government agency reports, and court decisions demonstrate
that individuals with disabilities face discrimination at every stage
of the medical treatment process. Biases and stereotypes about the
impact of disability affect decisions in different contexts, including
diagnoses, day-to-day treatment decisions, emergency care decisions,
and the allocation of scarce medical resources in health crises.\19\
Recent experiences during the COVID-19 public health emergency further
illustrate the harms that discrimination can pose. In March 2020 NCD
observed that ``discrimination by medical practitioners who, through
ignorance of the law or due to the belief that people with disabilities
are less valuable, and therefore less deserving of medical care, than
those who are not'' resulted in ``people with chronic illnesses and
other disabilities [being] left behind, denied resources to survive,
and as a result, suffer[ing] great losses of life.'' \20\
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\19\ See, e.g., Donlon v. Hillsborough Cnty., No. 18-cv-549-LM,
2019 WL 2062436 (D.N.H. May 9, 2019) (granting Plaintiff's motion
under the ADA to amend her complaint alleging that she was denied
medical treatment and emergency care because she had been
stereotyped based on her mental illness. The court said that ``[t]he
facts alleged raise a plausible inference of such unreasonable care
that would imply pretext for a discriminatory motive.''); Pesce v.
Coppinger, 355 F. Supp. 3d 35, 47 (D. Mass. 2018) (granting
Plaintiff's motion under the ADA for a preliminary injunction
because the failure of the correctional facility to provide
methadone for opioid addiction ``is either `arbitrary or capricious
as to imply that it was a pretext for some `discriminatory motive'
or `discriminatory on its face,' '' (citing Kiman v. N.H. Dep't of
Corr., 151 F.3d 274, 285 (1st Cir. 2006); Sumes v. Andres, 938 F.
Supp. 9, 12 (D.D.C. 1996) (finding that there was no bona fide
medical reason for a physician's refusal to treat the plaintiff, the
court held that the ADA and section 504 had been violated because
the denial of treatment was based on deafness); Howe v. Hull, 874 F.
Supp. 779, 788-89 (N.D. Ohio 1994) (denying Defendant's motion for
summary judgment under the ADA because the refusal of the hospital
to admit the plaintiff for treatment was based on her HIV status).
\20\ Letter from Nat'l Council on Disability to Roger Severino,
Dir., U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.,
(March 18, 2020), <a href="https://ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr">https://ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr</a>.
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We propose to clarify the general prohibition on discrimination
against qualified individuals with disabilities in the medical
treatment context and elaborate on specific prohibitions in this
context. ``Medical treatment'' is used in this section 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, rehabilitative,
or palliative. It includes the use of a wide range of regimens for both
physical and mental conditions, interventions, or procedures, such as
surgery; the prescribing, dispensing, or management of medications;
exercise; physical therapy; rehabilitation services; and the provision
of durable medical equipment.
Throughout this section, the terms ``provider'' and ``medical
professional'' are sometimes used in place of ``recipient,'' which is
defined in Sec. 84.10.
Discrimination Against People With Disabilities in Medical Treatment
Although section 504 has prohibited discrimination in any program
or activity receiving Federal financial assistance since it was
enacted, discrimination continues to underpin health inequities faced
by people with disabilities.\21\ People with disabilities have reduced
access to medical treatment, a reality that leads to significant health
disparities and poorer health outcomes.\22\ People with disabilities
are significantly more likely than people without disabilities to have
unmet medical, dental, and prescription needs.\23\ Unmet health care
needs contribute to various indicators of health inequity: for example,
individuals with disabilities in the United States have a shorter
average life expectancy than people without disabilities and are three
times as likely to have heart disease, stroke, diabetes, or cancer than
adults without disabilities.\24\ People with certain types of serious
mental illness have a significantly shorter life expectancy than the
general population,\25\ and people with mental illness have an
increased risk of physical disease, as well as reduced access to
adequate health care.\26\ Pregnant people with disabilities receive
poorer maternity care, experience higher incidents of pregnancy and
birth-related complications, and are eleven times more likely to
experience maternal
[[Page 63396]]
death than people without disabilities.\27\ People with physical
disabilities are less likely to receive mammograms, Pap smears, or
other recommended routine preventive screenings.\28\ People with
disabilities are also more likely to have risk factors associated with
cancer than people without disabilities.\29\ During the first year of
the COVID-19 pandemic, one-third of the individuals who died in the
United States were living in congregate settings, often to receive
necessary services and supports--the majority of whom were individuals
with disabilities.\30\ Adults with disabilities were also considerably
more likely than their peers without disabilities to either delay care
or not get needed medical care for health issues other than COVID-
19.\31\
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\21\ While this proposed section 504 regulation relates
specifically to disability discrimination, other categories of
discrimination, including discrimination on the basis of race,
color, national origin, sex (including pregnancy, sexual
orientation, and gender identity), and age, also impact the health
care system. Many of these forms of discrimination intersect with
disability discrimination, contributing to and at times exacerbating
the nature and extent of the harms people with disabilities
experience. In addition, many communities of color experience higher
rates of disability and health risks in the U.S. See, e.g., Centers
for Disease Control and Prevention, Adults with Disabilities:
Ethnicity and Race, <a href="https://www.cdc.gov/ncbddd/disabilityandhealth/materials/infographic-disabilities-ethnicity-race.html">https://www.cdc.gov/ncbddd/disabilityandhealth/materials/infographic-disabilities-ethnicity-race.html</a> (last visited
Oct. 1, 2022).
\22\ See, e.g., Nat'l Council on Disability, Bioethics and
Disability Report Series (2019), <a href="https://ncd.gov/publications/2019/bioethics-report-series">https://ncd.gov/publications/2019/bioethics-report-series</a>; Tara Lagu et al., The Axes of Access--
Improving Care Quality for Patients with Disabilities, 370 N. Engl.
J. Med. 1847 (May 2014); Tara Lagu et al., Ensuring Access to Health
Care for Patients with Disabilities, 175 JAMA Internal Med. 157
(Feb. 2015); Tim Gilmer, Equal Health Care: If Not Now, When?, New
Mobility (July 1, 2013), <a href="http://www.newmobility.com/equal-health-care-if-not-now-when">http://www.newmobility.com/equal-health-care-if-not-now-when</a>; Gloria L. Krahn et al., Persons with
Disabilities as an Unrecognized Health Disparity Population, 105 Am.
J. of Public Health S198 (2015); Kristi L. Kirschner et al.,
Structural Impairments that Limit Access to Health Care for Patients
with Disabilities, 297 JAMA 1121 (Mar. 2007).
\23\ See, e.g., Elham Mahmoudi et al., Disparities in Access to
Health Care Among Adults with Physical Disabilities: Analysis of a
Representative National Sample for a Ten-Year Period, 8 Disability &
Health J. 182 (Apr. 2015), <a href="https://doi.org/10.1016/j.dhjo.2014.08.007">https://doi.org/10.1016/j.dhjo.2014.08.007</a>; Stephen P. Gulley et al., Disability in Two
Health Care Systems: Access, Quality, Satisfaction, and Physician
Contacts among Working-Age Canadians and Americans with
Disabilities, 1 Disability & Health J. 196 (Oct. 2008).
\24\ Ctrs. for Disease Control & Prevention, Disability
Inclusion, <a href="https://www.cdc.gov/ncbddd/disabilityandhealth/disability-inclusion.html">https://www.cdc.gov/ncbddd/disabilityandhealth/disability-inclusion.html</a>; Valerie Forman-Hoffman et al., Disability
Status, Mortality, and Leading Causes of Death in the United States
Community Population, 53(4) Medical Care 346 (Apr. 2015), <a href="https://pubmed.ncbi.nlm.nih.gov/25719432">https://pubmed.ncbi.nlm.nih.gov/25719432</a>; Williams, M. et al., Exploring
Health Disparities Among Individuals with Disabilities within the
United States, Am. Pub. Health Ass'n. (Oct. 2020), <a href="https://apha.confex.com/apha/2020/meetingapp.cgi/Paper/473208">https://apha.confex.com/apha/2020/meetingapp.cgi/Paper/473208</a>; Nat'l Council
on Disability, Health Equity Framework for People with Disabilities
(2022), <a href="https://ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf">https://ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf</a>.
\25\ See, e.g., Andrea Fiorillo & Norman Sartorius, Mortality
Dap and Physical Comorbidity of People with Severe mental Disorders:
The Public Health Scandal Ann. Gen. Psychiatry 20, 52 (2021).
<a href="https://doi.org/10.1186/s12991-021-00374-y">https://doi.org/10.1186/s12991-021-00374-y</a>; Steve Brown et al.,
Twenty Five Year Mortality of a Community Cohort with Schizophrenia,
Br. J. Psychiatry (2010), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560167/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560167/</a>.
\26\ Joseph Firth et al., The Lancet Psychiatry Commission: A
Blueprint for Protecting Physical Health in People with Mental
Illness, The Lancet Psychiatry, Vol. 6, 675-712 (2019), <a href="https://doi.org/10.1016/S2215-0366">https://doi.org/10.1016/S2215-0366</a>(19)30132-4.
\27\ See, e.g., Jessica L. Gleason et al., Risk of Adverse
Maternal Outcomes in Pregnant Women with Disabilities, JAMA Network
Open (2021), <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787181">https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787181</a>; Willi Horner-Johnson et al., Perinatal Health
Risks and Outcomes Among US Women with Self-Reported Disability, 41
Health Aff. 2011 (Sep. 2022), <a href="https://doi.org/10.1377/hlthaff.2022.00497">https://doi.org/10.1377/hlthaff.2022.00497</a>.
\28\ Lisa Iezzoni et al., Associations Between Disability and
Breast or Cervical Cancers, Accounting for Screening Disparities,
Medical Care 139 (2021), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855335/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855335/</a>; see also, C. Brook Steele et al., Prevalence of Cancer
Screening Among Adults with Disabilities, United States, 2013.
Preventing Chronic Disease (2017), <a href="http://dx.doi.org/10.5888/pcd14.160312">http://dx.doi.org/10.5888/pcd14.160312</a>.
\29\ M.A. Nosek et al., Breast and Cervical Cancer Screening
Among Women with Physical Disabilities, 78 Archives of Physical
Medicine and Rehabilitation, S39 (1997), <a href="https://doi.org/10.1016/s0003-9993">https://doi.org/10.1016/s0003-9993</a>(97)90220-3; See also, Lisa Iezzoni, Cancer Detection,
Diagnosis, and Treatment for Adults with Disabilities, 23 Lancet
E164 (Apr. 2022), <a href="https://doi.org/10.1016/S1470-2045">https://doi.org/10.1016/S1470-2045</a>(22)00018-3.
\30\ Nat'l Council on Disability, The Impact of COVID-19 on
People with Disabilities, 87 (2021), <a href="https://ncd.gov/sites/default/files/NCD_COVID-19_Progress_Report_508.pdf">https://ncd.gov/sites/default/files/NCD_COVID-19_Progress_Report_508.pdf</a>.
\31\ Akobirshoev et al., Delayed Medical Care and Unmet Care
Needs Due to the COVID-19 Pandemic among Adults with Disabilities in
the US, 41 Health Aff. 1505 (Oct. 2022), <a href="https://doi.org/10.1377/hlthaff.2022.00509">https://doi.org/10.1377/hlthaff.2022.00509</a>.
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Although many factors contribute to these health inequities,
discriminatory medical decisions--often driven by stereotypes about
disability--are a key factor. The National Academies of Sciences,
Engineering, and Medicine report that provider assumptions about people
with disabilities limit health and health care for people with
disabilities, noting that health care providers assume that people with
disabilities ``differ in significant, meaningful, and somewhat
undefined ways from other people[;] that people with disabilities have
a lower level of cognitive ability, independence, and interest in
improving and maintaining current function; [and] that the quality of
life for a disabled person is severely compromised, [which] limits the
type, scope, and aggressiveness of considered treatment options.'' \32\
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\32\ Nat'l Acad. of Sciences, Engineering, & Med., People Living
with Disabilities: Health Equity, Health Disparities, and Health
Literacy: Proceedings of a Workshop (2018), <a href="https://doi.org/10.17226/24741">https://doi.org/10.17226/24741</a>.
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These assumptions have been documented in many programs and
activities that frequently receive HHS funding. For example, a 2021
study entitled ``Physicians' Perceptions of People with Disability and
Their Health Care'' found that large proportions of practicing U.S.
physicians appeared to hold biased or stigmatized perceptions of people
with disabilities, such as perceiving worse quality of life for people
with disabilities.\33\ The study showed that, for example, 82% of
doctors thought people with disabilities had a lower quality of life
than people without disabilities,\34\ only 40% felt confident in their
ability to provide the same level to care to patients with disabilities
as those without disabilities,\35\ and only 56% strongly agreed that
they welcomed patients with disabilities into their practice.\36\ A
related study released in January 2022 also made clear that many
physicians are uncertain about their legal responsibilities resulting
from laws prohibiting discrimination on the basis of disability or how
to ensure the provision of equitable care to patients with
disabilities.\37\ For example, more than 71% of physicians surveyed
provided incorrect answers about who makes decisions about reasonable
accommodations for patients with a disability.\38\ Another study
published in October 2022 found that some providers seek ways to avoid
treating patients with disabilities and to discharge them from their
practice.\39\ These medical provider attitudes do not reflect the high
quality of life reported by many people with disabilities. In 2019, NCD
observed, ``most report a high quality of life and level of happiness,
especially when they have access to the health care services and
supports that they need to equally participate in and contribute to
their communities.'' \40\ Most individuals with disabilities report an
excellent or good quality of life.\41\ As NCD noted previously, ``[. .
.] negative predictions of life quality have little to do with the
actual life experiences of people with disabilities. People with
disabilities commonly report more satisfaction with their lives than
others might have expected. Though they commonly encounter obstacles,
prejudice, and discrimination, most people with disabilities manage to
derive satisfaction and pleasure from their lives.'' \42\
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\33\ Lisa I. Iezzoni et al., Physicians' Perceptions of People
with Disability and Their Health Care, 40 Health Aff. 297 (Feb.
2021), <a href="https://pubmed.ncbi.nlm.nih.gov/33523739/">https://pubmed.ncbi.nlm.nih.gov/33523739/</a>.
\34\ Id. at 300.
\35\ Id.
\36\ Id. at 301.
\37\ Lisa I. Iezzoni et al., US Physicians' Knowledge about the
Americans with Disabilities Act and Accommodation of Patients with
Disability, 41 Health Aff. 96 (Jan. 2022), <a href="https://pubmed.ncbi.nlm.nih.gov/34982624/">https://pubmed.ncbi.nlm.nih.gov/34982624/</a>.
\38\ Id. at 100-101.
\39\ Tara Lagu et al., `I Am Not the Doctor For You':
Physicians' Attitudes about Caring for People with Disabilities, 41
Health Aff. 96 (Jan. 2022), <a href="https://doi.org/10.1377/hlthaff.2022.00475">https://doi.org/10.1377/hlthaff.2022.00475</a>.
\40\ Nat'l Council on Disability, Medical Futility and
Disability Bias (2019), <a href="https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf">https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf</a>; see also, Mary Crossley,
Ending-Life Decisions: Some Disability Perspectives, 33 Ga. St. U.
L. Rev. 900 (2017).
\41\ Lisa I. Iezzoni et al., Physicians' Perceptions of People
with Disability and their Health Care, 40 Health Aff. 297 (Feb.
2021), <a href="https://pubmed.ncbi.nlm.nih.gov/33523739/">https://pubmed.ncbi.nlm.nih.gov/33523739/</a> (citing GL Albrecht
et al, The Disability Paradox: High Quality of life against all
odds, 48 Soc. Sci. Med. 977 (1999)).
\42\ Nat'l Council on Disability, Assisted Suicide: A Disability
Perspective (1997), <a href="https://ncd.gov/publications/1997/03241997">https://ncd.gov/publications/1997/03241997</a>.
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Stereotypes about the value and quality of the lives of people with
disabilities have led to discriminatory medical decisions in both the
provision and denial of medical treatment.\43\ The general pattern of
discrimination against people with disabilities in medical treatment
decisions extends across the array of contexts in which recipients make
those decisions.
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\43\ See, e.g., Tara Lagu et al., `I am Not the Doctor For You:'
Physicians' Attitudes About Caring for People with Disabilities,
supra note 39 (``Many physicians also expressed explicit bias toward
people with disabilities and described strategies for discharging
them from their practices. Physicians raised concerns about the
expense of providing physical and communication accommodations,
including insufficient reimbursement for physicians' efforts and
competing demands for staff time and other practice resources. Many
participants described caring for very few patients who need
accommodations, with little acknowledgment that the barriers to
obtaining care and inability to track or respond to accommodation
needs could lead to an underidentification of the number of people
with disabilities who seek care.'').
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Below is a discussion of several of the most significant contexts
in which this pattern of discrimination has come to the Department's
attention, including in the areas of organ transplantation, denial of
life-sustaining care, crisis standards of care, participation in
clinical research, and other forms of medical treatment for people with
disabilities, including forced sterilization. Following that is a
subsection-by-subsection analysis of this proposed section.
[[Page 63397]]
Organ Transplantation
The Department plays a significant role in organ transplantation in
the U.S. Within the Department, the Health Resources & Services
Administration (HRSA) exercises oversight of solid organ
transplantation according to a statutory and regulatory framework. The
National Organ Transplant Act of 1984, as amended (NOTA) authorized the
establishment of the Organ Procurement and Transplantation Network
(OPTN) to allocate donor organs to individuals waiting for an organ
transplant.\44\ Under NOTA, the Secretary of Health and Human Services
(Secretary) contracts with a non-profit entity to operate the OPTN,
which currently is the United Network for Organ Sharing (UNOS).
Additionally, the Centers for Medicare & Medicaid Services (CMS) makes
payment for organ procurement costs under the Medicare and Medicaid
programs to organ procurement organizations (OPOs) that meet safety
requirements. Under Federal law, CMS is charged with certifying OPOs
that must meet the OPO Conditions for Coverage in the regulations at 42
CFR 486.301 through 486.360, which include outcome and process
measures.\45\ OPOs are non-profit organizations responsible for the
procurement of organs for transplantation. CMS also certifies that
transplant programs, located within hospitals with Medicare provider
agreements, perform transplantation procedures from living and deceased
donors. Transplant programs must comply with the Medicare transplant
program conditions of participation (CoPs) regulations at 42 CFR 482.68
through 482.104, and with the hospital CoPs at Sec. Sec. 482.1 through
482.58.
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\44\ Sec. 372, Public Law 98-507; 42 U.S.C. 274.
\45\ 42 U.S.C. 1320b-8; sec. 371(b)(3)(C) and sec. 1138(b) of
the Public Health Service Act (42 U.S.C. 273(b)(3)(C)).
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NCD published a 2019 report, ``Organ Transplant Discrimination
Against People with Disabilities,'' describing how people with
disabilities who are otherwise qualified candidates for an organ
transplant are excluded at many phases of the transplant process
because of health care providers' inaccurate assumptions about quality
of life, lifespan, and post-transplant compliance.\46\ In February
2022, NCD issued a ``Health Equity Framework for People with
Disabilities'' and recommended that HHS regulate this area.\47\ The NCD
organ transplant report states that discrimination occurs even though
disabilities unrelated to a person's need for an organ transplant
generally have little or no impact on the likelihood that the
transplant will be successful, and that, if a person with a disability
receives adequate support, their disability should have very limited
impact on their ability to adhere to a post-transplant care
regimen.\48\
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\46\ Nat'l Council on Disability, Organ Transplants
Discrimination against People with Disabilities: Part of the
Bioethics and Disability Series (2019), <a href="https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf">https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf</a>.
\47\ Nat'l Council on Disability, Health Equity Framework for
People with Disabilities (2022), <a href="https://ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf">https://ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf</a>.
\48\ Nat'l Council on Disability, Organ Transplants
Discrimination against People with Disabilities: Part of the
Bioethics and Disability Series, 38-40 (2019), <a href="https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf">https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf</a>.
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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.\49\ For example, in 2019, OCR resolved a case alleging
discrimination against an individual with autism spectrum disorder, in
which the complainant alleged the University of North Carolina 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 directly 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.\50\
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\49\ See, e.g., Bussoletti v. Univ. of Pitt. Med. Ctr. (07-
068765); Walker v. Univ. Cal. San Diego Med. Ctr. (08-80649);
Parsons v. Cnty of Santa Clara, Santa Clara Valley Med. Ctr. (07-
69439); Paladino v. Union City Renal Ctr. (06-44878); Beaton v.
Sutter Mem'l Hosp. (03-11505); Eggemeyer v. Ill. Dep't of Human
Serv. Randolph Cnty. Office (03-004371); HIV/AIDS Legal Servs
Alliance v. Health Plan P of Cal. (09-02-3296); Lewis v. Willis
Knighton Med. Ctr. (03-12129), on file with OCR. In at least one of
the above complaints, OCR recommended that the covered entity
evaluate its transplant listing policies after discovering that the
covered entity's policy listed ``severe mental retardation'' as a
contraindication for transplant.
\50\ See Disability Rts. of N.C. v. Univ. of N.C. Hosp., (19-
318735), <a href="https://www.hhs.gov/about/news/2019/02/12/ocr-resolves-disability-complaint-individual-who-was-denied-opportunity-heart-transplant-list.html">https://www.hhs.gov/about/news/2019/02/12/ocr-resolves-disability-complaint-individual-who-was-denied-opportunity-heart-transplant-list.html</a> (No violation was found but a voluntary
resolution agreement was entered into with the facility).
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The Department has heard from a number of stakeholders urging
action on this issue. On May 6, 2019, 17 major organizations that serve
and advocate for individuals with disabilities sent a letter asking OCR
to issue a regulation and guidance that addresses discriminatory
practices in organ transplantation.\51\ On October 12, 2016, a
bipartisan group of 30 members of Congress sent a letter to OCR urging
it to issue guidance on discrimination against individuals with
disabilities, particularly individuals with intellectual and
developmental disabilities, in organ transplantation.\52\ The letter
cited data documenting consideration of disability status in organ
transplantation. The Department agrees that action remains needed.
Moreover, while 34 states have passed State laws protecting the rights
of people with disabilities to access organ transplantation, 16 States
and the District of Columbia lack legislation addressing this
issue.\53\ And even where State laws do address this issue, it is
unclear whether those laws are adequately enforced. Additionally,
according to a 2019 NCD report, transplant centers in states that have
passed antidiscrimination legislation continue to publicly post
discriminatory criteria for organ transplantation, suggesting that some
State law requirements are not well-known or enforced.\54\
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\51\ Letter from Matt Valliere et al., to Roger Severino, Dir.,
U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts., (May 6,
2019). The letter is on file with OCR.
\52\ Letter from Thirty (30) Members of Congress to Jocelyn
Samuels, former Dir., U.S. Dep't of Health & Hum. Servs., Off. for
Civil Rts., (Oct. 12, 2016), on file with OCR.
\53\ Nat'l Down Syndrome Soc'y, Nondiscrimination in Organ
Transplantation Laws & Toolkit (2022), <a href="https://www.ndss.org/programs/ndss-legislative-agenda/healthcare-research/nondiscrimination-in-organ-transplantation-laws-toolkit/">https://www.ndss.org/programs/ndss-legislative-agenda/healthcare-research/nondiscrimination-in-organ-transplantation-laws-toolkit/</a>.
\54\ Nat'l Council on Disability, Organ Transplant
Discrimination Against People With Disabilities 53-54 (2019),
<a href="https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf">https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf</a>;
See also Isabella Newburg, Note, The Heart of the Discrimination
Problem: Insufficient State Protection for People with Intellectual
and Developmental Disabilities in the Organ Transplant Process, 107
Ia. L. Rev. 877, 894 (2022).
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Research has documented the persistence of organ transplantation
policies that discriminate against individuals with disabilities,
[[Page 63398]]
particularly against individuals with intellectual and developmental
disabilities, psychiatric disabilities, and HIV.\55\ A 2009 study
reported that 85% of pediatric transplant centers considered
neurodevelopmental status in evaluation, and 71% considered subnormal
IQ a relative or absolute contraindication to transplant.\56\ Programs
continue to list these conditions as reasons for denying transplants,
despite evidence that, for example, individuals with intellectual or
developmental disabilities who have received organ transplants have
rates of successful outcomes and medical adherence comparable to those
of the general population.\57\ A literature review published in
``Pediatric Transplantation'' found scant scientific data to support
the idea that having an intellectual or developmental disability would
pose a heightened risk of poorer outcomes following a transplant.\58\
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\55\ Nat'l Council on Disability, Organ Transplant
Discrimination Against People With Disabilities, 30 (2019), <a href="https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf">https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf</a>
(``Disability discrimination persists in the evaluation process
because, in spite of evidence to the contrary, many physicians still
view HIV and AIDS, as well as intellectual, developmental, or
psychiatric disabilities, as relative or absolute contraindications
to transplant.'').
\56\ Aaron Wightman et al., Consideration of Children with
Intellectual Disability as Candidates for Solid Organ
Transplantation--A Practice in Evolution, Pediatric Transplantation
22, no. 1 (Feb. 2018), citing Richards CT et al., Use of
Neurodevelopmental Delay in Pediatric Solid Organ Transplant Listing
Decisions: Inconsistencies in Standards across Major Pediatric
Transplant Centers. Pediatric Transplantation no. 13, 843-85 (2009).
\57\ See, e.g., E. Samuel-Jones et al., Cardiac Transplantation
in Adult Patients with Mental Retardation: Do Outcomes Support
Consensus Guidelines, 53 Psychomatics 133 (2012) (concluding people
with intellectual disabilities can receive long-term benefit from
heart transplantation when they have the support necessary to ensure
adherence to post-transplant regimens); Marilee Martens et al.,
Organ Transplantation, Organ Donation and Mental Retardation,
Pediatric Transplantation. 2006 Sept.;10(6):658-64 (reviewed the
literature on accessibility and outcomes of organ transplantation in
individuals with intellectual disability and on the prevalence of
organ donation in this population. The one- and three-year patient
survival rates were 100% and 90%, respectively).
\58\ Marilee A. Martens et al., Organ Transplantation, Organ
Donation, and Mental Retardation, 10 Pediatric Transplantation 658
(2006).
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In a policy statement, the American Society of Transplant Surgeons
recommends ``that no patient will be discriminated against or precluded
from transplant listing solely due to the presence of a disability or
handicap, whether physical or psychological . . . This [transplant]
decision would be made due to the clinical risk benefit analysis for
the specific patient, and not on any external factors.'' The Society
further indicates support for ``efforts to identify and eliminate any
Transplant Center processes or practices that allow discrimination.''
\59\
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\59\ Am. Soc'y of Transplant Surgeons, Statement Concerning
Eligibility for Solid Organ Transplant Candidacy (Feb. 12, 2021),
<a href="https://asts.org/about-asts/position-statements#.Ysxi0LfMKUk">https://asts.org/about-asts/position-statements#.Ysxi0LfMKUk</a>.
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Media reports have also documented denials of organ transplants
based on disability.\60\ For example, in 2013, the news widely covered
the initial denial of a kidney transplant to a three-year-old girl by
Children's Hospital of Philadelphia because she had Wolf-Hirschhorn
syndrome, which delays growth and causes intellectual and developmental
disabilities.\61\ In 2006, Oklahoma University Medical Center denied a
young woman placement on a waiting list for a kidney transplant based
on her diagnosis of Mild Intellectual Disability.\62\ In February 2022,
CBS News covered families' allegations that hospitals denied transplant
eligibility for children with Down syndrome and other developmental
disabilities.\63\ In addition, the general obligation to make
reasonable modifications for qualified individuals with disabilities
under proposed Sec. 84.68(b)(7) applies to organ transplantation. For
example, transplant programs receiving Federal financial assistance
must allow individuals to meet the requirement that they can manage
postoperative care needs with a reasonable modification, such as the
assistance of a formal or informal support system. These types of
supports may include, for example, support from family or friends, paid
services, long-term services and supports, and other forms of
assistance.
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\60\ See, e.g., Sara Reardon, Push Is On for States to Ban Organ
Transplant Discrimination, Kaiser Health News (Mar. 8, 2021),
<a href="https://khn.org/news/article/organ-transplant-discrimination-disabilities-state-legislation/">https://khn.org/news/article/organ-transplant-discrimination-disabilities-state-legislation/</a>; Sunshine Bodey, My Son Has Autism.
Discrimination Almost Cost Him His Life, Wash. Post (Aug. 30, 2017),
<a href="https://www.washingtonpost.com/opinions/my-son-has-autism-discrimination-almost-cost-him-his-life/2017/08/30/b899dc58-88e8-11e7-961d-2f373b3977ee_story.html">https://www.washingtonpost.com/opinions/my-son-has-autism-discrimination-almost-cost-him-his-life/2017/08/30/b899dc58-88e8-11e7-961d-2f373b3977ee_story.html</a>; Lenny Berstein, People with
Autism, Intellectual Disabilities Fight Bias in Transplants, Wash.
Post (Mar. 4, 2017), <a href="https://www.washingtonpost.com/national/health-science/people-with-autism-intellectual-disabilities-fight-bias-in-transplants/2017/03/04/756ff5b8-feb2-11e6-8f41-ea6ed597e4ca_story.html?utm_term=.144fbd126817">https://www.washingtonpost.com/national/health-science/people-with-autism-intellectual-disabilities-fight-bias-in-transplants/2017/03/04/756ff5b8-feb2-11e6-8f41-ea6ed597e4ca_story.html?utm_term=.144fbd126817</a>.
\61\ Kim Painter, Disabled NJ Girl Thrives, Inspires After
Transplant, USA Today (Oct. 5, 2013), <a href="https://www.usatoday.com/story/news/nation/2013/10/05/disabled-transplant-amelia-rivera/2917989/">https://www.usatoday.com/story/news/nation/2013/10/05/disabled-transplant-amelia-rivera/2917989/</a>.
\62\ David Shapiro, Disabled Woman Dies While Awaiting Second
Chance at Transplant, NPR (June 13, 2012), <a href="https://www.npr.org/sections/health-shots/2012/06/13/154914089/disabled-woman-dies-while-awaiting-second-chance-at-kidney-transplant">https://www.npr.org/sections/health-shots/2012/06/13/154914089/disabled-woman-dies-while-awaiting-second-chance-at-kidney-transplant</a>.
\63\ Michael Roppolo, They Say Their Children Are Being Denied
Transplants Because of Their Disabilities. A New Federal Law May
Help Change That., CBS News, (Feb. 28, 2022), <a href="https://www.cbsnews.com/news/organ-transplants-discrimination-disability-rights">https://www.cbsnews.com/news/organ-transplants-discrimination-disability-rights</a>.
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The continuing evidence of discrimination against individuals with
disabilities in organ transplantation demonstrates the need for a rule
specifically discussing the application of section 504's requirements
in the medical treatment context.
Life-Sustaining Treatment
People with disabilities face significant discrimination in access
to life-sustaining care. These discriminatory judgments arise when
clinicians seek to end the continued provision of life-sustaining care
that is still actively sought by a person with a disability or their
authorized representative. This proposed rule uses the term ``life-
sustaining care'' here broadly, to encompass both critical care
treatment and life-saving or life-extending care provided outside the
context of an acute medical crisis. Discrimination is particularly
salient in the context of medical futility determinations, when
hospitals and providers decide to discontinue or deny medical treatment
based on the judgment that the treatment would do little or nothing to
benefit the patient.\64\ Section 504 does not prohibit giving medical
providers discretion to make medical futility judgments; it does
require that medical futility judgments be made on a nondiscriminatory
basis. There is ample evidence that perceptions about patients with
disabilities' quality of life often affects judgments related to
patient benefit and leads to the discriminatory denial of life-
sustaining care. The result can be premature death for patients with
disabilities.
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\64\ Medical futility sometimes goes under other names such as
``nonbeneficial treatment.''
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NCD published a report in 2019 examining the issue of medical
futility determinations and disability bias, discussing decisions by
health care providers to withhold or withdraw life-sustaining care for
individuals with disabilities that are driven by subjective quality of
life judgments.\65\ Clinical literature documents how futility
determinations can be used to deny care to people with disabilities
based on their use of assistive technology, ongoing support needs, and
other factors that do not prevent a treatment from being effective in
saving or extending life.\66\ As discussed above,
[[Page 63399]]
recent research has documented that a large proportion of practicing
physicians in the United States hold biased perceptions of people with
disabilities, in particular perceiving people with disabilities as
having worse quality of life (in contrast to the self-perception of
many people with disabilities themselves).\67\ Such perceptions of the
quality of life of people with disabilities can play a role in the
discriminatory use of futility determinations to deny medically
effective care.
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\65\ Nat`l Council on Disability, Medical Futility and
Disability Bias: Part of the Bioethics and Disability Series (Nov.
2019), <a href="https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf">https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf</a>.
\66\ See LJ Schneiderman et al., Medical Futility: Its Meaning
and Ethical Implications, 112 Ann. Intern. Med. 949 (1990)
(indicating the use of assistive technology, ongoing support needs,
etc. in futility determinations). See also Maryam Aghabaray et al.,
Medical Futility and its Challenges: a Review Study, 9 J. Med.
Ethics & History of Med. 11 (2016), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/</a> (clarifying the continued use of these
standards in the present day).
\67\ Lisa I. Iezzoni et al., Physicians' Perceptions of People
with Disability and Their Health Care, 40 Health Aff. 297 (Feb.
2021), <a href="https://pubmed.ncbi.nlm.nih.gov/33523739/">https://pubmed.ncbi.nlm.nih.gov/33523739/</a>, citing GL Albrecht
et al., The Disability Paradox: High Quality of Life Against All
Odds, 48 Soc. Sci. Med. 977 (1999).
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Of particular concern are determinations by providers that an
intervention should not be provided if it ``fails to return or sustain
an acceptable quality of life'' for a patient in the judgment of the
provider, even if the patient or their authorized representative would
consider such an outcome acceptable.\68\ For example, the idea that if
treatment ``cannot end dependence on intensive medical care, the
treatment should be considered futile,'' \69\ may discriminate against
people whose disabilities create continuing support needs. Similarly,
some sources have defined futility in terms of an inability to exit a
hospital or institutional long-term care setting \70\ or a patient's
reliance on others for activities of daily living.\71\ When these
definitions are used to deny care to people with disabilities, they are
likely to be discriminatory.
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\68\ L. Morata, An Evolutionary Concept Analysis of Futility in
Health Care, 74 J. Advanced Nursing 1289 (June 2018).
\69\ Id.
\70\ L.J. Schneiderman et al., Medical Futility, 118 Handbook of
Clinical Neurology 167 (Jan. 2013); Morata L., supra note 68.
\71\ R. Sibbald, et al., Perceptions of ``Futile Care'' Among
Caregivers in Intensive Care Units, 177 CMAJ 1201 (Nov. 2007);
M[uuml]ller R, Kaiser S. et al., Perceptions of Medical Futility in
Clinical Practice-a Qualitative Systematic Review, 48 J. Critical
Care 78 (Dec. 2018).
---------------------------------------------------------------------------
Physicians discriminate on the basis of disability when they act
based on judgments that a patient's life is not worth living because
they have a disability that substantially limits their major life
activities and bodily functions, e.g., they may need assistance with
the activities of daily living. Denying a medical treatment on that
basis if the treatment would be provided to a similarly situated
patient without a disability is discrimination on the basis of
disability. As discussed earlier in this section, 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.\72\
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\72\ Gary Albrecht et al., The Disability Paradox: High Quality
of Life Against All Odds, 48 Soc. Sci. Med. 977 (Apr. 1999); Sonia
Frick et al., Medical Futility: Predicting Outcome of Intensive Care
Unit Patients by Nurses and Doctors--a Prospective Comparative
Study, 456 Critical Care Med. (Feb. 2003); Lisbeth [Oslash]rtenblad
et al., Users' Experiences With Home Mechanical Ventilation: A
Review of Qualitative Studies, Respiratory Care 1157 (Sep. 2019);
Peter A. Ubel et al., Whose Quality of Life? A Commentary Exploring
Discrepancies Between Health State Evaluations of Patients and the
General Public, Quality of Life Research, 599 (Sept. 2003).
---------------------------------------------------------------------------
One study of the application of medical futility determinations
found that mobility status, and particularly a patient's immobility
(defined as being ``bed-bound or only able to move from bed to
chair''), played a significant role in providers' determinations of
qualitative futility--that is, determinations that an intervention will
not return or sustain an acceptable quality of life--suggesting that
physicians may be more likely to determine that a patient's likely
outcome is unacceptably poor and should thus be considered medically
futile if the patient has a mobility impairment.\73\ In the same study,
one-third of the determinations of futility based on perceptions of a
patient's quality of life were made without a discussion with the
patient about their perception of their quality of life, a significant
problem given that patients frequently report substantially different
perceptions of their own quality of life than their physicians
assume.\74\ A 2016 review found that futility determinations continue
to be used by physicians and that such judgments often take into
account clinician perceptions of patient quality of life, including
dependence on life-sustaining equipment, devices, and medications.\75\
This clinical literature supports the view that qualitative futility
judgments are used to deny access to life-sustaining care against the
wishes of the patient or their authorized representative based on
clinician judgments that the life of a given patient with a disability
is not worth living.\76\
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\73\ J.R. Curtis et al., Use of the Medical Futility Rationale
in Do-Not-Attempt-Resuscitation Orders, 273 JAMA 124, 125 (1995).
\74\ Id. See also Gary Albrecht et al., The Disability Paradox:
High Quality of Life Against All Odds, 48 Soc Sci Med. 977 (Apr.
1999).
\75\ Maryam Aghabaray et al., Medical Futility and its
Challenges: A Review Study, 9 J. of Med. Ethics and History of Med.
11 (2016), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/</a>.
\76\ Nat'l Council on Disability, Medical Futility and
Disability Bias, Part of the Bioethics and Disability Series (2019),
<a href="https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf">https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf</a>; Maryam Aghabaray et al.,
Medical Futility and its Challenges: A Review Study, 9 J. Med.
Ethics & History of Med. 11 (2016), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/</a>; Dominic J. Wilkinson et al., Knowing When
to Stop: Futility in the Intensive Care Unit, 2 Current Op. in
Anesthesiology 24 (2011), <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3252683/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3252683/</a> (recognizing that judgments concerning qualitative
futility led to cessation of care in intensive care units).
---------------------------------------------------------------------------
In 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,'' 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.'' \77\
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\77\ 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 Am. J.
Respiratory & Critical Care Med. 1318 (June 2015).
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Disability and civil rights organizations have expressed serious
concern regarding disability discrimination in medical futility
decisions and other areas regarding denial of life-sustaining care. In
a July 10, 2018, letter from 22 disability organizations to OCR and to
HHS' Administration for Community Living (ACL), the writers noted that
sometimes medical determinations of futility are motivated by
inappropriate consideration of cost or value judgments regarding the
quality of life of individuals with disabilities seeking life-saving
medical treatment rather
[[Page 63400]]
than an assessment of the individual's ability to benefit from
treatment.\78\
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\78\ Letter from 22 organizations to U.S. Dep't of Health & Hum.
Servs., Off. for Civil Rts and Admin. for Cmty. Living (July 10,
2018), on file with OCR.
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On May 6, 2019, a coalition of 17 leading organizations that
advocate for or serve individuals with disabilities wrote to OCR,
raising selected disability discrimination issues.\79\ They pointed to
``so-called `futile care' laws and policies, which allow doctors to
deny life-sustaining treatment to individuals with disabilities who
want and need it.'' On September 3, 2019, the American Civil Liberties
Union wrote a letter to OCR highlighting that medical futility
determinations are an area of concern for discrimination against
individuals with disabilities.\80\ OCR has also heard from stakeholders
that discrimination in medical futility determinations and biased
provider counseling remain sources of concern for people with
disabilities and may result in the denial of medically effective life-
sustaining treatment against the wishes of patients with disabilities
and their authorized representatives.\81\
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\79\ Letter from Matt Valliere et al., on behalf of 17
organizations, to U.S. Dep't of Health & Hum. Servs., Off. for Civil
Rts (May 6, 2019), on file with OCR.
\80\ See Memorandum from Ronald Newman et al., American Civil
Liberties Union, to U.S. Dep't of Health & Hum. Servs., Off. for
Civil Rts. (Sep. 3, 2019), on file with OCR.
\81\ See, e.g. Letter from Nat'l Council on Disability to U.S.
Dep't of Health & Hum. Servs., Off. for Civil Rts., (Dec. 11, 2019)
(HHS on assisted suicide, medical futility and QALYs reports),
<a href="https://ncd.gov/publications/2019/ncd-letter-hhs-3-bioethics-reports">https://ncd.gov/publications/2019/ncd-letter-hhs-3-bioethics-reports</a>; Letter from Nat'l Council on Disability to U.S. Dep't of
Health & Hum. Servs., Off. for Civil Rts., (Mar. 18, 2020)
(addressing COVID-19, <a href="https://ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr">https://ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr</a>; Letter from Consortium of Citizens with
Disabilities to Sec'y Azar, U.S. Dep't of Health & Hum. Servs. &
Roger Severino, Director, OCR, (Mar. 20, 2020) (addressing COVID-19
and disability discrimination), <a href="https://www.c-c-d.org/fichiers/Letter-re-COVID-19-and-Disability-Discrimination-final.pdf">https://www.c-c-d.org/fichiers/Letter-re-COVID-19-and-Disability-Discrimination-final.pdf</a>; Letter
from 27 Members of the House and five Senators to Alex Azar, Sec'y,
U.S. Dep't of Health & Hum. Servs. & Bill Barr, Att'y Gen., U.S.
Dep't of Justice, (Mar. 25, 2020) (urging HHS, AG to Protect
Disability Community), <a href="https://chrissmith.house.gov/uploadedfiles/2020-03-25_bipartisan_bicameral_letter_to_hhs_and_doj_-_covid-19_and_disability_discrimination.pdf">https://chrissmith.house.gov/uploadedfiles/2020-03-25_bipartisan_bicameral_letter_to_hhs_and_doj_-_covid-19_and_disability_discrimination.pdf</a>; Letter from eight senators to
Sec'y. Azar, Admin. Verma, and Dir. Severino U.S. Dep't of Health &
Hum. Servs (Apr. 10, 2020) (related to Rationing of Care) <a href="https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf">https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf</a>
; Letter from eight senators to Sec'y. Azar, Admin. Verma, and Dir.
Severino U.S. Dep't of Health & Hum. Servs (Apr. 10, 2020) (related
to Rationing of Care) <a href="https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf">https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf</a>
; Press Release, Am. Assoc. People with Disabilities, Over 400
Organizations Urge Department of Health and Human Services to Issue
Guidance to Prohibit Discrimination during Medical Rationing (Apr.
17, 2020), <a href="https://www.aapd.com/press-releases/civil-rights-letter-covid-medical-rationing/?fbclid=IwAR0uKHogSaq8zknb--gVKL9-oplHXyX1a1lGpyx306WHpr0ZQWoxSk2C1oM">https://www.aapd.com/press-releases/civil-rights-letter-covid-medical-rationing/?fbclid=IwAR0uKHogSaq8zknb--gVKL9-oplHXyX1a1lGpyx306WHpr0ZQWoxSk2C1oM</a>; Letter from Autistic Self
Advocacy Network, DREDF, Epilepsy Foundation, Justice in Aging and
The Arc of the United State to Melanie Fontes Rainer, Acting Dir.,
OCR and Samuel Bagenstos, General Counsel, U.S. Dep't of Health &
Hum. Servs. (Aug. 18, 2022), on file with OCR. Over 400
Organizations Urge Department of Health and Human Services to Issue
Guidance to Prohibit Discrimination during Medical Rationing (Apr.
17, 2020), <a href="https://www.aapd.com/press-releases/civil-rights-letter-covid-medical-rationing/?fbclid=IwAR0uKHogSaq8zknb--gVKL9-oplHXyX1a1lGpyx306WHpr0ZQWoxSk2C1oM">https://www.aapd.com/press-releases/civil-rights-letter-covid-medical-rationing/?fbclid=IwAR0uKHogSaq8zknb--gVKL9-oplHXyX1a1lGpyx306WHpr0ZQWoxSk2C1oM</a>; Letter from Autistic Self
Advocacy Network, DREDF, Epilepsy Foundation, Justice in Aging & The
Arc of the United State to Melanie Fontes Rainer, Acting Dir., OCR &
Samuel Bagenstos, Gen. Counsel, U.S. Dep't of Health & Hum. Servs.
(Aug. 18, 2022), on file with OCR.
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Crisis Standards of Care
When an emergency or crisis has a substantial effect on usual
health care operations and the level of care that is possible to
deliver, hospitals and health systems may adopt crisis standards of
care. These policies may authorize or recommend prioritization of
scarce resources through means not used outside of crisis conditions.
OCR received numerous complaints against states alleging disability
discrimination relating to crisis standards of care during the early
months of the COVID-19 public health emergency. Federal agencies,
advocates, the media, members of the public, and other stakeholders
also raised general concerns about the potential for discrimination on
the basis of disability in the application of these standards.\82\
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\82\ On March 25, 2020, a bipartisan bicameral Congressional
coalition sent then-Secretary Azar and then-Attorney General Barr a
letter asking HHS to notify states of their civil rights obligations
as they review and develop their crisis standards of care. Lankford,
Gillibrand Lead Bipartisan, Bicameral Call to Protect Civil Rights
for People with Disabilities Amidst COVID-19 Pandemic,
<a href="http://lankford.senate.gov">lankford.senate.gov</a> (Mar. 25, 2020). This call followed an earlier
letter to OCR by the National Council on Disability asking for
similar guidance. Letter from Nat'l Council on Disability to U.S.
Dep't of Health & Hum. Servs., Off. for Civil Rts. (Mar. 18, 2020),
<a href="https://www.ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr">https://www.ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr</a>.
Since the NCD letter, a variety of national organizations
representing broad-based constituents have reached out to OCR with
similar requests, including the Consortium on Citizens with
Disabilities, Cystic Fibrosis Research, Inc., the Disability Rights
Education and Defense Fund, the National Disability Rights Network,
National Right to Life, and others.
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OCR resolved a number of civil rights complaints and provided
technical assistance to recipients, including complaints against
Tennessee,\83\ Utah,\84\ North Carolina,\85\ several regional consortia
of hospital systems within Texas,\86\ and Arizona,\87\ among others,
regarding application of their triage and ventilator allocation
guidelines to individuals with disabilities. In February 2022, OCR
released a guidance document entitled ``Frequently Asked Questions for
Providers during the COVID-19 Public Health Emergency: Federal Civil
Rights Protections for Individuals with Disabilities under Section 504
and Section 1557.'' The document includes a section on crisis standards
of care.\88\ The guidance was intended to assist states and providers
seeking to comply with applicable civil rights laws during the COVID-19
public health emergency. That guidance was specific to the
circumstances of the COVID-19 pandemic. The Department proposes to
address in this proposed regulation the application of section 504 to
the allocation of scarce medical treatments or other resources more
generally.
---------------------------------------------------------------------------
\83\ See U.S. Dep't of Health & Hum. Servs., Off. for Civil Rts.
OCR Resolves Complaint with Tennessee After it Revises its Triage
Plans to Protect Against Disability Discrimination (Jun. 26, 2020),
<a href="https://www.hhs.gov/about/news/2020/06/26/ocr-resolves-complaint-tennessee-after-it-revises-its-triage-plans-protect-against-disability.html">https://www.hhs.gov/about/news/2020/06/26/ocr-resolves-complaint-tennessee-after-it-revises-its-triage-plans-protect-against-disability.html</a>.
\84\ See U.S. Dep't of Health & Hum. Servs., Off. for Civil
Rts., OCR Resolves Complaint with Utah After it Revised Crisis
Standards of Care to Protect Against Age and Disability
Discrimination (Aug. 20, 2020), <a href="https://www.hhs.gov/about/news/2020/08/20/ocr-resolves-complaint-with-utah-after-revised-crisis-standards-of-care-to-protect-against-age-disability-discrimination.html">https://www.hhs.gov/about/news/2020/08/20/ocr-resolves-complaint-with-utah-after-revised-crisis-standards-of-care-to-protect-against-age-disability-discrimination.html</a>.
\85\ See U.S. Dep't of Health & Hum. Servs., Off. for Civil
Rts., OCR Provides Technical Assistance to Ensure Crisis Standards
of Care Protect Against Age and Disability Discrimination (Jan. 14,
2021), <a href="https://www.hhs.gov/about/news/2021/01/14/ocr-provides-technical-assistance-ensure-crisis-standards-of-care-protect-against-age-disability-discrimination.html">https://www.hhs.gov/about/news/2021/01/14/ocr-provides-technical-assistance-ensure-crisis-standards-of-care-protect-against-age-disability-discrimination.html</a>.
\86\ See id.
\87\ See U.S. Dep't of Health & Hum. Servs., Off. for Civil
Rts., OCR Provides Technical Assistance to the State of Arizona to
Ensure Crisis Standards of Care Protect Against Age and Disability
Discrimination (May 25, 2021), <a href="https://www.hhs.gov/about/news/2021/05/25/ocr-provides-technical-assistance-state-arizona-ensure-crisis-standards-care-protect-against-age-disability-discrimination.html">https://www.hhs.gov/about/news/2021/05/25/ocr-provides-technical-assistance-state-arizona-ensure-crisis-standards-care-protect-against-age-disability-discrimination.html</a>.
\88\ U.S. Dep't of Health & Hum. 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>.
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The COVID-19 public health emergency has illustrated the importance
of regulating in this area, including within the context of crisis
standards of care. For example, many crisis standards of care protocols
issued prior to and during the COVID-19 public health emergency
included categorical exclusions of people with disabilities from access
to critical care despite their possessing the potential to benefit from
treatment. Recipients may not categorically exclude individuals with
disabilities or groups of individuals with disabilities from critical
care provided that treatment is
[[Page 63401]]
not futile for said individuals. Judgments of futility may not be based
on criteria otherwise prohibited in this section or elsewhere in
section 504.\89\ Similarly, many crisis standards of care protocols
included other forms of discrimination on the basis of disability that
did not involve categorical exclusions, such as prioritizing resources
on the basis of patients' anticipated life-expectancy long after their
acute care episode. OCR has previously clarified that a patient's
likelihood of survival long after hospital discharge is unlikely to be
related to the need to make allocation decisions about scarce resources
on a temporary basis or the effectiveness of the medical interventions
being allocated, and thus should not be used as a prioritization
criterion in crisis standards of care protocols.\90\
---------------------------------------------------------------------------
\89\ Ari Ne'eman et al., The Treatment of Disability under
Crisis Standards of Care: an Empirical and Normative Analysis of
Change over Time during COVID-19, 45 J. Health Polit. Policy Law 831
(2021), <a href="https://doi.org/10.1215/03616878-9156005">https://doi.org/10.1215/03616878-9156005</a>.
\90\ U.S. Dep't of Health & Hum. 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>.
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Participation in Clinical Research
Clinical research participation can offer considerable benefit to
both the individuals participating within it 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. Longstanding
literature, including a recent report from the National Academies of
Science, Engineering and Medicine, has highlighted the problem of the
systemic exclusion of women, people of color, and other marginalized
groups from clinical research.\91\ Such exclusions harm those who are
denied the direct benefits of research participation. They also
threaten the generalizability of research findings and potentially the
reach of subsequent medical innovations for those groups who are
excluded.
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\91\ Nat'l Acad. of Science, Engineering & Med., Improving
Representation in Clinical Trials and Research: Building Research
Equity for Women and Underrepresented Groups, The Nat'l Acad. Press
(2022), <a href="https://doi.org/10.17226/26479">https://doi.org/10.17226/26479</a>.
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Recent research has documented that people with disabilities also
face systemic and unnecessary exclusion from clinical research.\92\
Although study exclusions can be justifiable based on the nature of the
clinical research being conducted, exclusions 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. They also may be the result of overly
broad exclusion 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 exclusion 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.
---------------------------------------------------------------------------
\92\ 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 broad exclusion criteria 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 with
persons who are deaf, have vision loss, or otherwise need alternative
forms of communication.
Nondiscriminatory Criteria
Section 84.4(b)(4), while being revised in the amendment segment of
this proposed rule, results in the text being redesignated as Sec.
84.68(b)(3), prohibits the use of discriminatory methods of
administration, criteria, and protocols, including discrimination in
the allocation of scarce resources. Resources necessary for medical
treatment are sometimes scarce for a variety of reasons. A therapeutic
agent or vaccine may be newly developed, and production may not yet
have caught up to the level of demand for it. More generally, supply
chain issues may prevent drugs, devices, and equipment from getting to
places where they are needed. And, as was evidenced in the response to
COVID-19, medical emergencies may overtax hospitals and the larger
health care system. In circumstances like these, recipients may find it
necessary to create a protocol or methodology for allocating those
treatments and resources.
This section does not require hospitals or the broader health care
system to allocate resources in any specific way; it just prohibits
them from using criteria that subject individuals with disabilities to
discrimination on the basis of disability. For example, as OCR has
previously indicated in guidance,\93\ 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. Similarly, if recipients deny a patient with
disabilities access to resources because of forecasts that the person
may not live as long as an individual without a disability after
treatment, this may also discriminate against persons with
disabilities.\94\ The further in the future a provider looks to
establish a patient survival prediction, the less likely that
prediction will be related to the medical effectiveness of the
resources being rationed during the temporary shortage, and doing so
may screen out people with disabilities without being necessary to
operate a program of critical care.\95\
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\93\ U.S. Dep't of Health & Hum. 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>.
\94\ See id. at Question 7.
\95\ Id.
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Certain criteria for allocating scarce medical treatments may
discriminate against people with disabilities even if they rely on
predictions of short-term mortality. For example, 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
[[Page 63402]]
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.'' \96\ Similar impacts may
exist for other types of disabilities and other prognostic scoring
tools, measures, diagnostic instruments, and methodologies for
assessment or the allocation of scarce medical resources.
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\96\ 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 must 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 assess the
inability of a person with cerebral palsy to articulate words, but it
would be discriminatory to use that determination to indicate an actual
mortality risk that is not implied by that disability. Similarly, some
crisis standards of care protocol have used ``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. However, 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.\97\
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\97\ 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>.
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Sec. 84.56(a) Discrimination Prohibited
Proposed Sec. 84.56(a) confirms the basic requirement that no
qualified individual with a disability shall, on the basis of
disability, be subjected to discrimination in medical treatment under
any program or activity that receives Federal financial assistance,
including in the allocation or withdrawal of any good, benefit, or
service. Section 84.56(a) makes specific the general prohibition of
disability-based discrimination proposed in Sec. 84.68(a), as well as
the general prohibition that applies to health, welfare, and other
social services in Sec. 84.52(a), and underscores that those
prohibitions broadly apply to medical treatment decisions made by
recipients.
For example, a patient with HIV seeks surgery for an orthopedic
condition. A recipient refuses to provide treatment because of a belief
that individuals with HIV are responsible for their condition and
should thus not receive costly medical resources. This rationale is
discriminatory on the basis of disability in this context.\98\
Similarly, this paragraph would cover situations where a recipient
declines to treat a person with certain disabilities, including
psychiatric, intellectual, and developmental disabilities because the
treating professional is uncomfortable providing care based on
stereotypical beliefs about persons with that disability, or where the
recipient declines to treat persons with a substance use disorder based
on a belief that these persons are less likely to comply with treatment
protocols.
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\98\ See Bragdon v. Abbott, 524 U.S. 624 (1998). HIV is
contained in the list of physical or mental impairments in the ADA
regulations and it substantially limits major life activities
because it affects the immune system and the reproductive system. 35
CFR 35.108. Similarly, under the section 504 regulations that mirror
the ADA language, HIV will virtually always be found to be an
impairment that substantially limits a major life activity. HIV
infection typically leads to a determination of disability. In
addition, the patient in this example would be protected under the
``regarded as'' provision based on the recipient's action and
justification.
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Scope of Discrimination Prohibited
The text of section 504 is clear and broad. Section 504 prohibits
discrimination on the basis of disability in programs or activities
receiving Federal financial assistance. Section 504's ``program or
activity'' language provides no basis for excluding some activities in
which recipients engage--such as medical treatment--from the statute's
facially broad coverage. A recipient's failure to provide treatment to
an individual with disabilities who meets all qualifications for the
medical treatment results in a denial of health care to a person with
disabilities and, barring any applicable limitation, constitutes
discrimination in violation of section 504.
The intended breadth of section 504 is reflected in the Civil
Rights Restoration Act (CRRA), which made clear that section 504
applies to ``all the operations of an entity that receives Federal
financial assistance.'' \99\ As amended by the CRRA, section 504's
``program or activity'' language provides no basis for excluding some
actions in which recipients engage--such as medical treatment--from the
statute's facially broad coverage. In addition, in interpreting the
ADA, which is modeled on section 504--the Supreme Court has recognized
the law's broad coverage in accordance with its language. In
particular, in Pennsylvania Department of Corrections v. Yeskey, the
Supreme Court refused to carve prison conditions cases out of title
II's coverage.\100\ When the state argued that prison conditions were
significantly different than the circumstances that Congress sought to
address in the statute, the Court responded, ``the fact that a statute
can be applied in situations not expressly anticipated by Congress does
not demonstrate ambiguity. It demonstrates breadth.'' \101\
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\99\ 29 U.S.C. 794(b).
\100\ 524 U.S. 206 (1998).
\101\ Id. at 212 (internal quotation marks omitted).
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[[Page 63403]]
Indeed, the Supreme Court has itself applied both section 504 and
the ADA to medical treatment decisions. In Bowen v. American Hospital
Association, seven justices considered on the merits the argument that
section 504 prohibited the withholding of medical care; the plurality
found no violation of section 504 on the particular facts of that case
because the lack of consent for treatment made the infants at issue not
``otherwise qualified.'' \102\ And in Bragdon v. Abbott, the Court held
that title III of the ADA applied to a dentist's refusal to fill the
cavity of a patient with HIV, and that the dentist could defeat the
lawsuit only if he could show that treating the patient presented
``significant health and safety risks'' based ``on medical or other
objective evidence.'' \103\
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\102\ 476 U.S. 610, 624 (1986).
\103\ 524 U.S. 624, 649 (1998).
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Some lower Federal courts have questioned the manner and reach of
section 504 as applied to medical treatment decisions. In United States
v. University Hospital, the Second Circuit considered the application
of section 504 to infants born with multiple birth defects.\104\ The
court stated that the law's term ``otherwise qualified'' could not
ordinarily be applied ``in the comparatively fluid context of medical
treatment decisions without distorting its plain meaning.'' \105\ Some
courts have read this language as broadly suggesting that section 504
does not apply to medical treatment decisions. \106\ But that is not
the fairest reading of University Hospital. The Second Circuit there
principally relied on the argument that it will often be difficult to
identify discrimination when an individual challenges a covered
entity's treatment of the underlying disability itself.\107\ The lower
court cases following University Hospital seem to draw the same
line.\108\
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\104\ 729 F.2d 144 (2d Cir. 1984).
\105\ Id. at 156. The lower court cases following University
Hospital have relied on University Hospital's reasoning: ``Where the
handicapping condition is related to the conditions to be treated,
it will rarely, if ever, be possible to say . . . that a particular
decision was `discriminatory.' '' Univ. Hosp. at 157. In Johnson v.
Thompson, one of University Hospital's progeny, the court,
addressing potential medical interventions for a newborn infant with
Spina Bifida, noted that situations exist where individuals with
disabilities could be considered ``otherwise qualified'' even under
University Hospital's view of ``otherwise qualified.'' Johnson v.
Thompson, 971 F.2d 1487,1493 (10th Cir. 1992).
\106\ See, e.g., Schiavo ex rel. Schindler v. Schiavo, 403 F.3d
1289, 1294 (11th Cir. 2005) (``The Rehab Act, like the ADA, was
never intended to apply to decisions involving . . . medical
treatment.'').
\107\ United States v. Univ. Hosp., 729 F.3d at 157 (``Where the
[disabling] condition is related to the condition(s) to be treated,
it will rarely, if ever, be possible to say with certainty that a
particular decision was `discriminatory'.'').
\108\ See Cushing v. Moore, 970 F.2d 1103, 1109 (2d Cir. 1992)
(``[A]s we have observed in the past, we must be careful in applying
Sec. 504's `otherwise qualified' language to programs where a
patient's [disability] gives rise to the need for the services in
question.''); Johnson by Johnson v. Thompson, 971 F.2d 1487, 1494 n.
3 (10th Cir. 1992) (following University Hospital but recognizing
that section 504 might be violated where ``the [disability] that
forms the basis of the section 504 discrimination bears no relation
to the medical treatment sought but denied''); Schiavo ex rel.
Schindler v. Schiavo, 403 F.3d 1289, 1294 (11th Cir. 2005)
(following University Hospital and Johnson based on the conclusion
that the plaintiff sought treatment to alleviate the very condition
that constituted a disability).
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Consistent with what we believe to be the correct reading of the
statute and the case law, we propose in this rule to draw a distinction
between circumstances where individuals are seeking treatment for the
underlying disability and those in which individuals are seeking
treatment for a separately diagnosable condition or symptom. Compare
proposed Sec. 84.56(b)(1) (providing specific, albeit non-exhaustive,
circumstances in which forbidden discrimination exists whether or not
the individual seeks treatment for a condition or symptom that is
separately diagnosable from the underlying disability) with proposed
Sec. 84.56(b)(2) (providing a broader general rule of
nondiscrimination for cases in which a recipient uses the underlying
disability as the basis for discriminating against an individual who
seeks treatment for a separately diagnosable symptom or medical
condition).
As discussed below, with respect to separately diagnosable
conditions, the proposed rule does not require that the condition be
entirely unrelated to the underlying disability; it is instead intended
to reach circumstances in which the condition for which medical
treatment is sought is sufficiently distinct from the underlying
disability such that the person with the disability can be considered
similarly situated to a person without the disability for treatment
purposes. That a separately diagnosable heart condition is related to
an underlying disability in some manner is irrelevant under the
proposed rule if the underlying disability makes no difference to the
``clinically appropriate treatment'' for the heart condition. This
approach is consistent with the mandate that persons with disabilities
be accorded equal treatment under section 504.
In circumstances in which an individual is seeking treatment for a
condition that is not ``separately diagnosable'' under proposed Sec.
84.56(b)(2), the rule's application is relatively narrow but
nonetheless is critical to prevent prohibited discrimination.
Consistent with proposed Sec. 84.56(c)(1)(ii), the rule would not
apply if the refusal to treat is in circumstances in which the
``recipient typically declines to provide the treatment to any
individual, or reasonably determines based on current medical knowledge
or the best available objective evidence that such medical treatment is
not clinically appropriate for a particular individual.'' The rule,
however, specifies in proposed Sec. 84.56(c)(1)(ii) that providers do
not make legitimate medical judgments when they base decisions on the
criteria contained in Sec. 84.56(b)(1)(i)-(iii): ``[b]ias or
stereotypes about a patient's disability,'' ``[j]udgments that the
individual will be a burden on others,'' 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.''
The recognition of the need to defer to reasonable medical judgment
but to prohibit biased decision-making is consistent with University
Hospital and other lower court cases. Even assuming those cases were
correctly decided on their facts, none of them suggest that bias is
permissible under section 504 simply because there is a relationship
between a sought-after medical treatment and an underlying
disability.\109\ In such circumstances, the rule ensures that medical
judgment is in fact being exercised with respect to the person with a
disability's qualification for that treatment. Lower courts have
applied section 504 to medical treatment decisions consistent with this
approach.\110\
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\109\ See, e.g., Lesley v. Chie, 250 F. 3d 47, 55 (1st Cir.
2001) (finding that, for example, ``a plaintiff may argue that her
physician's decision was so unreasonable--in the sense of being
arbitrary and capricious--as to imply that it was pretext for some
discriminatory motive . . .'').
\110\ Id.; see also Glanz v. Vernick, 756 F. Supp. 632, 638 (D.
Mass. 1991) (``A strict rule of deference would enable doctors to
offer merely pretextual medical opinions to cover up discriminatory
decisions.'').
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Proposed Sec. 84.56(b) elaborates on the basic requirement in
Sec. 84.56(a) by providing a non-exhaustive set of examples of conduct
that would violate that requirement.
Sec. 84.56(b)(1) Denial of Medical Treatment
Proposed Sec. 84.56(b)(1) addresses denial of treatment. It makes
explicit that a recipient is prohibited from denying or limiting
medical treatment to a qualified individual with a disability
[[Page 63404]]
when the denial is based on (i) bias or stereotypes about a patient's
disability; (ii) judgments that an individual will be a burden on
others due to their disability, including, but not limited to,
caregivers, family, or society; or (iii) a belief that the life of a
person with a disability has a lesser value than that of a person
without a disability, or that life with a disability is not worth
living. This paragraph reflects a straightforward application of the
prohibition on discriminating against qualified individuals with
disabilities on the basis of a disability. Denying, limiting, or
withholding treatment for any of the prohibited reasons is
discrimination on the basis of disability because the decision is
driven by the recipient's perception of disability rather than by
consideration of effectiveness of the treatment or other legitimate
reasons.
As defined in the proposed rule at Sec. 84.10, a ``qualified
individual with a disability'' is ``an individual with a disability
who, with or without reasonable modifications to rules, policies, or
practices, the removal of architectural, communication, or
transportation barriers, or the provision of auxiliary aids and
services, meets the essential eligibility requirements for the receipt
of services or the participation in programs or activities provided by
a recipient.'' Proposed Sec. 84.56(b)(1) clarifies that bias,
stereotypes, judgments about burden on others, and beliefs that
disabled lives have lesser value or worth or are not worth living are
not permissible ``essential'' eligibility requirements for medical
treatment. As noted by the Supreme Court in Alexander v. Choate, to
treat such discriminatory factors as ``qualifications'' under section
504 would impermissibly allow the ``benefit'' at issue to ``be defined
in a way that effectively denies qualified individuals [with
disabilities] the meaningful access to which they are entitled.'' \111\
---------------------------------------------------------------------------
\111\ 469 U.S. 287, 301 (1985).
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In School Board of Nassau County v. Arline, the Supreme Court said
that in section 504, ``Congress acknowledged that society's accumulated
myths and fears about disability and disease are as [disabling] as are
the physical limitations that flow from actual impairment.'' \112\ The
impermissible factors set forth in the proposed rule exemplify the
harmful impact of the myths, fears, and stereotypes that Congress
targeted in the statute. As discussed above, there is significant
evidence that assessments of the impact of a disability on quality of
life may lead a provider to make medical decisions that reflect myths,
fears, and stereotypes, and tend to screen out individuals with
disabilities or classes of individuals with disabilities from fully and
equally enjoying the benefits of medical treatment.
---------------------------------------------------------------------------
\112\ 480 U.S. 273, 284 (1987).
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Proposed paragraph 84.56(b)(1)(i) confirms the prohibition against
denying or limiting medical treatment based on bias or stereotypes. For
example, refusing to provide a person with an Opioid Use Disorder (OUD)
a referral for Medications for Opioid Use Disorder (MOUD) due to a
provider's belief that persons with OUD will not adhere to treatment
protocols would be prohibited under this paragraph.
Proposed paragraph (b)(1)(ii) prohibits denying or limiting medical
treatment based on judgments that an individual will be a burden on
others due to their disability, including but not limited to
caregivers, family, or society. For example, Sec. 84.56(b)(1)(ii)
would be violated if an individual with a disability needed a medically
indicated surgical procedure but it was denied because of a recipient's
judgment that the postoperative care the patient would need after the
surgery because of the patient's disability would be an unfair burden
on the individual's caregivers, family, or society.
Proposed paragraph (b)(1)(iii) prohibits 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. For
example, 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.
For example, a patient with Alzheimer's disease covered as a
disability under section 504 has developed pneumonia and is in need of
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 such
support, 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. 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 proposed Sec. 84.56(b)(1)(iii). If the physician
also denied the ventilator support because of a perception that it
would be a burden for his husband to care for the patient, the
physician would also have violated Sec. 84.56(b)(1)(ii).
As another example, 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
[[Page 63405]]
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).
The Department notes that this provision does not require
clinicians or other health care providers to offer medical treatment
that is outside their scope of practice. That a treatment is outside
the typical scope of practice of a given provider is a legitimate
nondiscriminatory reason for the denial or limitation of treatment.
However, if the provider would typically provide a referral to another
provider for whom a given treatment is within their scope of practice,
a refusal to provide such a referral on the basis of disability would
likely constitute a violation of this paragraph.
Sec. 84.56(b)(2) Denial of Treatment for a Separate Symptom or
Condition
Proposed Sec. 84.56(b)(2) addresses situations where a person with
a disability seeks or consents to treatment for a separately
diagnosable symptom or medical condition, whether or not the symptom or
condition is itself a disability or is causally connected to the
disability that is the basis for coverage under section 504. (In this
proposed rule, we use the phrase ``underlying disability'' to refer to
a disability that triggers coverage under section 504 and that is
different than the separately diagnosable symptom or medical condition
for which the patient seeks treatment.) Often individuals with a
disability will seek treatment for a separately diagnosable symptom or
medical condition. For example, a person with Down syndrome might seek
a heart transplant to address a heart condition; a person with spinal
muscular atrophy might seek treatment for a severe case of COVID-19; or
a person with a spinal cord injury might seek treatment for depression
with suicidal ideation. The section makes clear that a recipient may
not deny or limit clinically appropriate treatment if it would be
offered to a similarly situated individual without an underlying
disability, including based on predictions about the long-term impact
of the underlying disability on the individual's life expectancy.
Violations of Sec. 84.56(b)(1)(iii) may also violate Sec.
84.56(b)(2). For example, as described above in the discussion of Sec.
84.56(b)(1)(iii), a recipient who denies a ventilator to a patient with
severe Alzheimer's disease who has pneumonia because of a belief that
the patient's life is not worth living based on their disability has
violated Sec. 84.56(b)(1)(iii) if the ventilator would have been
offered to a similarly situated individual without an underlying
disability, in this case, Alzheimer's disease. In addition, the
recipient has also violated Sec. 84.56(b)(2) because of the denial of
treatment of a separate condition.
As another example described above in the discussion of Sec.
84.56(b)(1)(iii), a recipient who withholds antibiotics and other
medical care from a teenage boy with intellectual and developmental
disabilities because of a belief that the boy's life has a lesser value
than the life of a person without a disability violates Sec.
84.56(b)(1)(iii) when the antibiotics and medical care would have been
offered to a similarly situated individual without an underlying
disability . In this situation, Sec. 84.56(b)(2) has also been
violated because of the failure to treat a separate condition.
For purposes of proposed paragraph (b)(2), it does not matter
whether the symptom or condition for which the individual is seeking
treatment is also a disability under section 504. Heart conditions,
COVID-19, and depression could all meet the statute's definition of
disability in appropriate circumstances, but people who experience
discriminatory treatment for these conditions based on an underlying
disability are entitled to the protections of this paragraph. 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.
Individuals with Down syndrome are more likely to experience heart
conditions, and a spinal cord injury may be the event that triggers an
individual's depression. But a refusal to treat a heart condition
because of a judgment regarding the disability of Down syndrome, or a
refusal to treat depression because of a patient's underlying spinal
cord injury, will violate this paragraph if it is made on the basis of
the prohibited grounds.
<bullet> Medical Treatment Question 1: We recognize that the line
between disabilities may in some cases be more difficult to draw than
in these examples, and we welcome comment on the best way of
articulating the relevant distinctions.
Similarly, a symptom or condition that arises from a common
underlying biological mechanism as a patient's underlying disability,
such as Kaposi's sarcoma in a person with AIDS, is a separately
diagnosable symptom or condition for the purposes of this section. The
crucial point is that where a qualified individual or their authorized
representative seeks or consents to treatment for a separately
diagnosable symptom or condition, a recipient may not deny or limit
that treatment if it would offer that treatment to a similarly situated
person without the underlying disability. In each of these cases, the
recipient will have discriminated against a qualified individual with a
disability on the basis of disability in violation of proposed Sec.
84.56(b)(2).
These obligations must be interpreted in light of the rule of
construction in proposed Sec. 84.56(c) on professional medical
judgment, which indicates 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.
For example, under this rule of construction, a recipient may take into
account a patient's underlying disability to deny a medical treatment
based on their judgment that the treatment would not be effective at
accomplishing its intended effect or because an alternative course of
treatment to the one that would typically be provided to patients
without disabilities would be more likely to be successful in light of
a patient's disability.
Sec. 84.56(b)(3) Provision of Medical Treatment
Proposed Sec. 84.56(b)(3) addresses the discriminatory provision
of medical treatment. It states that if a medical professional provides
an individual with a disability different treatment than the
professional would provide an individual without a disability seeking
assistance with the same condition--and there is nothing about the
disability that impairs the effectiveness, or ease of administration of
the treatment itself or has a medical effect on the condition to which
the treatment is directed--proposed Sec. 84.56(b)(3) has been
violated. For example, if a woman with an intellectual disability seeks
a prescription for contraception but her provider, due to a belief that
any children she may have are likely to have an intellectual
disability, offers only surgical sterilization, the recipient has
violated proposed Sec. 84.56(b)(3) if the provider prescribes
contraception for her other patients without disabilities. However,
proposed Sec. 84.56(b)(3) does not prohibit a recipient from providing
[[Page 63406]]
services or equipment to an individual with an underlying disability
that are different than that provided to others with the same condition
when necessary to provide an effective service or treatment to the
individual with a disability. Where, for example, an individual
recovering from a foot or leg injury or surgery has an anatomical loss
of an arm and is unable to use crutches as a result, it would not
violate Sec. 84.56(b)(3) to recommend or prescribe a knee scooter to
the patient even though the recipient recommends crutches to most
patients in this situation.
Where an underlying disability would interfere with the efficacy of
a particular treatment, a recipient could provide a person with that
disability a different treatment than it would provide to similarly
situated nondisabled individuals. For example, an underlying health
condition that itself is a disability might require an individual to
take a medication that is contraindicated with a particularly effective
antiviral drug. If that individual contracts COVID-19, it would not
violate this section for a recipient to offer a different treatment
than the contraindicated antiviral drug, even if it is generally less
effective. Because the underlying disability would directly inhibit the
utility of the generally more effective drug, the individual would not
be qualified for that treatment under this part.
The Department proposes this provision in part to address
discriminatory conduct based on the belief that persons with
disabilities are entitled to less bodily autonomy than nondisabled
persons--a belief that underpins the history of forced sterilization
provided as ``medical treatment'' for individuals with intellectual,
mental health, and developmental disabilities. In the twentieth
century, over thirty states allowed and funded involuntary
sterilization of disabled women and men with disabilities. In 1927, the
Supreme Court sanctioned such sterilization programs in Buck v. Bell,
ruling that ``society can prevent those who are manifestly unfit from
continuing their kind . . . Three generations of imbeciles are
enough.'' \113\ States continued to use Federal funds for forced
sterilizations of institutionalized individuals until 1978, when HEW
published regulations requiring the ``institutionalized'' individual's
informed consent to the procedure.
---------------------------------------------------------------------------
\113\ Buck v. Bell, 274 U.S. 200, 207 (1927).
---------------------------------------------------------------------------
Yet, many individuals who were subjected to such involuntary
sterilizations experienced and continue to experience trauma and grief
because of these State-sanctioned practices. In June 2022, the New York
Times ran a story about the lingering trauma for three Black sisters
with disabilities who were sterilized in 1973 without their or their
parents' informed consent because clinic workers judged them
``intellectually inferior.'' \114\ Three states--Virginia, North
Carolina, and California--offer compensation to victims of State-
sanctioned programs.\115\
---------------------------------------------------------------------------
\114\ Linda Villarosa, ``The Long Shadow of Eugenics in
America,'' N.Y. Times (Jun. 8, 2022).
\115\ Id.
---------------------------------------------------------------------------
While State-run sterilization programs have ended, involuntary
sterilization continues today. According to a 2021 report, fourteen
states allow a judge to order the sterilization of a person with a
disability who is not under guardianship.\116\ Although specific cases
are difficult to identify due to the secrecy surrounding the procedure,
the Department believes that this is an important area in which to
regulate in order to protect the rights of persons with
disabilities.\117\ The proposed rule would bar recipients from
performing sterilization on the basis of disability to an individual
with a disability where they would not provide the same treatment to an
individual without a disability, unless it has a medical effect on the
condition to which the treatment is directed.\118\
---------------------------------------------------------------------------
\116\ Nat'l Women Law Ctr., Forced Sterilization of Disabled
People in the United States, 56 (Jan. 2022), <a href="https://nwlc.org/wp-content/uploads/2022/01/%C6%92.NWLC_SterilizationReport_2021.pdf">https://nwlc.org/wp-content/uploads/2022/01/%C6%92.NWLC_SterilizationReport_2021.pdf</a> and
the related Appendix, <a href="https://nwlc.org/wp-content/uploads/2022/01/%C6%92.NWLC_SterilizationReport_2022_Appendix.pdf">https://nwlc.org/wp-content/uploads/2022/01/%C6%92.NWLC_SterilizationReport_2022_Appendix.pdf</a> (referencing laws
and court decisions in California, Connecticut, Delaware, Georgia,
Idaho, Indiana, Maine, Maryland, New Jersey, New York, North Dakota,
South Carolina, and Vermont).
\117\ Id. at 32.
\118\ This provision would not prohibit medical treatment where
a person with a disability seeks or consents to sterilization.
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<bullet> Medical Treatment Question 2: The Department seeks comment
on other examples of the discriminatory provision of medical treatment
to people with disabilities.
Sec. 84.56(c) Construction
Proposed Sec. 84.56(c) sets forth a series of principles guiding
how Sec. 84.56 should be interpreted.
Sec. 84.56(c)(1) Professional Judgment in Treatment
Proposed Sec. 84.56(c)(1) specifically addresses professional
judgment in treatment and its relationship to the proposed
nondiscrimination provisions regarding medical treatment. Paragraph
(c)(1)(i) provides 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.
For example, it would not violate Sec. 84.56(c)(1)(i) if a recipient
declines to provide chemotherapy to a patient with a disability based
on a judgment that it would not extend the patient's life or mitigate
the symptoms of the patient's cancer. Similarly, a provider who refuses
to perform cardiopulmonary resuscitation on a patient with signs of
irreversible death or a clinician who refuses to administer antifungals
as a treatment for a heart attack would not be in violation of this
section where such interventions would not accomplish the intended goal
of treatment. Nor would a recipient be in violation of this section if
it determined that a patient with a disability would be exceedingly
unlikely to survive cardiac surgery and thus judged that it would not
be medically appropriate to provide such treatment.
Similarly, a recipient would not be in violation of this section if
it determined that an alternative course of treatment to the one that
would typically be provided to patients without disabilities would be
more likely to be successful in light of a patient's disability. For
example, should a recipient determine that the use of an older
medication has a lower risk of side effects because of interactions
with a patient's disability as compared to a newer medication that is
now commonly prescribed, using the older medication would not
constitute an impermissible limitation on access to medical treatment.
These examples, which are based on individualized, fact-specific
inquiries, are legitimate nondiscriminatory reasons for denying or
limiting treatment and remain within the appropriate province of
medical judgment.
We note that proposed Sec. 84.68(b)(8) permits the imposition of
eligibility criteria that screen out people with disabilities from
receiving the benefit of medical care only when they are shown to be
necessary for the provision of this aid, benefit, or service. The rule
does nothing to disturb the ability of physicians to exercise their
professional judgment based on the current medical knowledge or the
best available objective evidence that a treatment is or is not
clinically appropriate.
Paragraph (c)(1)(ii) states that circumstances in which the denial
of treatment is permitted include those in which the recipient
typically declines to provide the treatment to any individual, and
those in which the recipient
[[Page 63407]]
reasonably determines based on current medical knowledge or the best
available objective evidence that such medical treatment is not
clinically appropriate for a particular individual. The regulatory text
makes clear that the criteria prohibited in paragraphs (b)(1)(i)-(iii)
are not legitimate nondiscriminatory reasons for denying or limiting
medical treatment and may not be a basis for a determination that an
individual is not qualified for the treatment or that a treatment is
not clinically appropriate for a particular individual. Recipients may
not judge clinical appropriateness 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 provider's 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.
A provider might also decline to provide a service to any
individual if it is outside their scope of practice. For example, an
orthopedic surgeon might decline to provide a treatment to children,
including children with disabilities, if pediatric surgery is not
within her scope of service. However, the provider could not refuse to
offer pediatric referrals for children with disabilities when it
typically refers children without disabilities to appropriate care.
As another example, assume that a recipient decides to deny a
person with an intellectual disability who uses mechanical ventilation
access to sought-after life-saving care on the grounds that they
believe the presence of a cognitive disability and a need for breathing
support together render the patient's quality of life so poor as to
render continued life of no benefit to them and not worth living
(despite the patient themself or their authorized representative
seeking life-saving treatment). This is not a permissible basis for
determining that a disability has rendered an individual with a
disability unqualified for treatment. Nor is this a legitimate
nondiscriminatory reason for denying or limiting a health service on
the basis of disability, as the denial is motivated by the provider's
belief that a person with a disability has lesser value than a person
without a disability and that life with a disability is not worth
living, both of which are prohibited under paragraph (b)(1)(iii).
In contrast, a recipient could deny medical treatment to a person
with a disability on the grounds that it is not clinically appropriate
if it poses substantial added risk to the patient that cannot be
ameliorated. For example, for a person with a disability at much higher
risk of death from a potential surgery, a recipient's decision not to
provide such a surgical intervention in light of that heightened
mortality risk would be a legitimate, nondiscriminatory reason to deny
the surgery in question even if it was sought by a patient with a
disability.
Similarly, if a recipient declines to provide a treatment on the
grounds that existing evidence only supports its medical effectiveness
for a particular subpopulation that the patient with a disability
seeking treatment is not a part of, this might be a legitimate
nondiscriminatory reason for denying access to the treatment under some
circumstances, provided the recipient generally denies such or similar
treatments to patient populations for whom the evidentiary basis is
similarly lacking or inconclusive. However, if a recipient generally
provides such or similar treatments even in the presence of a similar
evidentiary record for their effectiveness (or lack of effectiveness),
denying such treatments to a patient with a disability on those grounds
may not be a legitimate nondiscriminatory reason.
The Department notes that many types of treatment, such as
pharmacological interventions, are often studied on populations that
are not completely representative of the general patient population,
but these treatments nonetheless are routinely prescribed to patient
populations with conditions excluded from participation in the clinical
trial without further research. In those circumstances, it would not
necessarily be a legitimate nondiscriminatory reason to deny a patient
with a disability access to a broadly prescribed heart medication
simply because patients with her disability were excluded from the
clinical trial that established the medication's effectiveness.
However, should a recipient believe based on current medical knowledge
or the best available objective evidence that the heart medication is
likely to be ineffective, have dangerous side effects, or otherwise be
harmful to patients with that disability, this would constitute a
legitimate nondiscriminatory reason to deny access. Physicians have
substantial discretion to assess mixed or inconclusive evidence
regarding effectiveness according to their own judgment.
<bullet> Medical Treatment Question 3: The Department seeks
comment, including from health care professionals and people with
disabilities, on the examples described in this section, whether
additional examples are needed, and on the appropriate balance between
prohibiting discriminatory conduct and ensuring legitimate professional
judgments.
Sec. 84.56(c)(2) Consent
Proposed Sec. 84.56(c)(2) addresses consent. Section
84.56(c)(2)(i) makes clear that this section does not require a
recipient to provide medical treatment to an individual where the
individual, or the person legally authorized to make medical decisions
on behalf of that individual, does not consent to that treatment. This
subsection thus adopts the plurality's holding in Bowen v. American
Hospital Association that the denial of treatment to an individual
because of a lack of consent to treatment ``cannot violate Sec. 504.''
\119\ (The Department conceded that point during the Bowen
litigation.\120\) In such a case, the Bowen plurality said, the lack of
consent means that the individual is not ``qualified'' for treatment--
because treatment without consent violates deep-rooted common-law
principles endorsed in every State--and the denial of treatment would
be based on the lack of consent, not on disability.\121\
---------------------------------------------------------------------------
\119\ 476 U.S. 610, 630 (1986).
\120\ Id.
\121\ See id.
---------------------------------------------------------------------------
Another issue arising from the Bowen litigation is the extent to
which the Department is able to issue regulations concerning newborn
infants. The district court in Bowen had ``declared invalid and
enjoined `[a]ny other actions' of the Secretary `to regulate treatment
involving impaired newborn infants taken under authority of Section
504, including currently pending investigation and other enforcement
actions.' '' \122\ But the Bowen plurality specifically rejected any
reading of that injunction as barring ``all possible regulatory and
investigative activity that might involve the provision of health care
to handicapped infants.'' \123\ Instead, the four-justice plurality
read the injunction as limited to cases in which the Department sought
to require medical treatment despite a lack of parental consent.\124\
Indeed, the plurality specifically concluded ``that `handicapped
individual' as used in Sec. 504 includes an infant who is born with a
congenital defect,'' and that the statute protects qualified infants
against disability-based discrimination in
[[Page 63408]]
medical services.\125\ The three Bowen dissenters rejected the
plurality's narrow reading of the injunction; they believed that the
district court did in fact bar the Department from ``issu[ing] any
regulations whatsoever that dealt with infants' medical care.'' \126\
But they concluded that such a broad injunction was not consistent with
the law.\127\ In short, of the seven justices who addressed the issue
in Bowen, not one endorsed an injunction that would entirely bar the
Secretary from regulating medical discrimination against disabled
newborns.\128\ Accordingly, the Department does not believe that the
Bowen injunction, as affirmed by the Supreme Court, requires us to
carve newborns out of this rule. The Department does, however, follow
the Bowen plurality in declining to require a recipient to provide
medical treatment to an individual where the individual, or the person
legally authorized to make medical decisions on behalf of that
individual, does not consent to that treatment in situations where
consent would typically be required regardless of whether the
individual had a covered disability.
---------------------------------------------------------------------------
\122\ Id. at 626 n.11 (plurality opinion) (quoting the district
court's injunction).
\123\ Id.
\124\ See id.
\125\ Id. at 624.
\126\ Id. at 650 (White, J., dissenting).
\127\ See id. at 656 (``Where a decision regarding medical
treatment for a handicapped newborn properly falls within the
statutory provision, it should be subject to the constraints set
forth in Sec. 504. Consequently, I would reverse the judgment
below.'').
\128\ Chief Justice Burger concurred in the result without
opinion, and therefore expressed no view on the issue, and Justice
Rehnquist took no part in the decision.
---------------------------------------------------------------------------
Denial of treatment is not the only way a recipient can
discriminate on the basis of disability in its covered programs or
activities. When it enacted the Civil Rights Restoration Act two years
after Bowen, Congress explicitly provided that section 504 applies to
``all of the operations of'' a covered program or activity.\129\ The
operations of covered health care providers are not typically limited
to providing treatments. They also include the provision of advice and
the process of providing information to comply with informed-consent
requirements established by state law and otherwise. Proposed paragraph
(c)(2)(ii) makes clear that discrimination in obtaining informed
consent is prohibited independently of whether that discrimination is
followed by a decision to withhold treatment--or whether such a
subsequent decision to withhold treatment is itself discriminatory. For
example, a covered hospital may not repeatedly request that a patient
with a disability (or the patient's legally authorized representative)
consent to a do-not-resuscitate order, where it would not make such
repeated requests of a similarly situated nondisabled patient. In
addition, a recipient may not condition access to treatment on a
patient with a disability or their authorized representative agreeing
to a particular advanced care planning decision when they would not
implement or enforce such a requirement on a similarly situated
nondisabled patient.
---------------------------------------------------------------------------
\129\ 29 U.S.C. 794(b).
---------------------------------------------------------------------------
Numerous reports have demonstrated the existence of this sort of
biased treatment. The case of Sarah McSweeney, documented as part of a
National Public Radio (NPR) investigation into multiple reports of
individuals with disabilities pressured to agree to the withdrawing or
withholding of life-sustaining care, offers one example of potential
discrimination in access to life-sustaining care.\130\ Ms. McSweeney
was a 45-year-old woman with multiple disabilities who was admitted to
the hospital due to concerns that she may have contracted COVID-19.
Shortly after arriving, her guardian received a call from the hospital
questioning why her Physician Orders for Life-Sustaining Treatment
(POLST) form indicated that Ms. McSweeney should receive life-
sustaining treatment if she required it. Over the next several weeks,
media reports indicate that hospital personnel pressured Ms.
McSweeney's guardian to consent to the withdrawal or withholding of
life-sustaining care, often expressing skepticism that a person whose
disabilities precluded mobility and speech could be considered to have
quality of life. Ultimately, Ms. McSweeney died of sepsis due to
aspiration pneumonia, a typically treatable condition, although her
guardians repeatedly pushed for full care measures that the doctors
declined to administer.\131\
---------------------------------------------------------------------------
\130\ Joseph Shapiro, ``As Hospitals Fear Being Overwhelmed by
COVID-19, Do the Disabled Get the Same Access?'', Nat'l Pub. Radio
(Dec. 14, 2020) <a href="https://www.npr.org/2020/12/14/945056176/as-hospitals-fear-being-overwhelmed-by-covid-19-do-the-disabled-get-the-same-acc">https://www.npr.org/2020/12/14/945056176/as-hospitals-fear-being-overwhelmed-by-covid-19-do-the-disabled-get-the-same-acc</a>.
\131\ Id.
---------------------------------------------------------------------------
In some cases, patients with disabilities with routine illnesses or
their authorized representatives are pressured by their physicians to
agree to not be resuscitated, against their desires and wishes,\132\
with potentially deadly consequences. For example, a 2012 report from
the National Disability Rights Network documented instances of
providers steering individuals with disabilities or their family
members to agree to decline life-sustaining care or consent to the
withdrawal of life-sustaining care.\133\ In one instance, family
members reported that the patient's doctor informed them that their
relative--a 72-year-old patient with a developmental disability--would
have poor quality of life based on their disability and, as a result,
life-sustaining treatment should no longer be used. \134\ Though they
initially consented to the withdrawal of treatment, the family
eventually withdrew that consent, though they experienced pressure from
the clinician when attempting to restore treatment and nutrition.
---------------------------------------------------------------------------
\132\ Lauren Drake, New Oregon Law Bars Discrimination Against
People with Disabilities During Pandemic, Or. Pub. Broadcasting
(Jul. 11, 2020), <a href="https://www.opb.org/news/article/law-bars-disability-discrimination-covid-19/">https://www.opb.org/news/article/law-bars-disability-discrimination-covid-19/</a>.
\133\ Nat'l Disability Rts. Network, Devaluing People with
Disabilities: Medical Procedures that Violate Civil Rights (May
2012), <a href="https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf">https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf</a>.
\134\ Id. at 17.
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In its report, Medical Futility and Disability Bias, NCD discusses
the example of Terrie Lincoln who, at age 19, was in an automobile
accident that severed her spinal cord and caused her to become
quadriplegic.\135\ The report describes that when Terrie ``was in the
hospital just following her accident, Terrie's doctors repeatedly tried
to influence her family to `pull the plug,' stating that Terrie was a
`vegetable' and, even if she were to regain consciousness, would have
no quality of life.'' \136\ When Terrie did regain consciousness, she
was pressured by her doctors to forego additional medical treatment
that would extend her life due to judgments that life with the
disability of quadriplegia was not worth living. This would be a
violation of the proposed regulation under both 84.56(b)(1) and
(c)(2)(ii). Terrie persisted, later coming off the ventilator, earning
degrees in social work and public administration, and becoming a
disability rights advocate and mother. It is the Department's intent
for the proposed Sec. 84.56(c)(2)(ii) to apply both to instances in
which a recipient seeks consent to withdraw care in situations where
the withdrawal of care would not be sought from a person without a
disability (such as to deny routine care for a treatable medical
condition for which the patient has given no indication that they wish
to decline treatment) and situations where the manner in which consent
is sought is discriminatory in nature (such as by
[[Page 63409]]
pressuring patients with a disability or their authorized
representatives to agree to provide consent to decline or withdraw
treatment or to agree to a particular advanced care planning decision
authorizing such declining or withdrawal in the future).
---------------------------------------------------------------------------
\135\ Nat'l Council on Disability, Medical Futility and
Disability Bias, 27 (Nov. 20, 2019), <a href="https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf">https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf</a>.
\136\ Id.
---------------------------------------------------------------------------
Sec. 84.56(c)(3) Providing Information
Proposed Sec. 84.56(c)(3) addresses the information exchange
between the recipient and the patient with a disability concerning the
provision of information and potential courses of treatment and their
implications, including the option of foregoing treatment. This
provision indicates that nothing in this section precludes a provider
from providing an individual with a disability or their authorized
representative with information regarding the implications of different
courses of treatment based on current medical knowledge or the best
available objective evidence.\137\ The ability of a person with a
disability or their authorized representative to understand the
available options and to make an informed decision about the medical
treatment depends in part on the expertise and candor of the treating
professionals. However, as proposed Sec. 84.56(c)(2)(ii) indicates,
the recipient is prohibited from discriminating on the basis of
disability in seeking consent for the decision to treat or to forego
treatment by, for example, unduly pressuring a person with a disability
or their authorized representative to conform to the treating
professional's position or by relying on the prohibited factors listed
in proposed Sec. 84.56(b)(1)(i)-(iii).
---------------------------------------------------------------------------
\137\ This requirement with regard to the provision of
information is not a new standard and is consistent with similar
requirements in the medical ethics context. See, e.g., Am. Med.
Ass'n., Code of Med. Ethics, Chap. 2: Opp. on Consent, Communication
and Decision Making (2019), <a href="https://www.ama-assn.org/system/files/2019-06/code-of-medical-ethics-chapter-2.pdf">https://www.ama-assn.org/system/files/2019-06/code-of-medical-ethics-chapter-2.pdf</a>.
---------------------------------------------------------------------------
The Department realizes that providing regulatory requirements
concerning medical treatment requires careful consideration.
<bullet> Medical Treatment Question 4: The Department seeks comment
from all stakeholders on the risks and benefits of the proposed
regulatory choices that the Department has put forth in this section.
<bullet> Medical Treatment Question 5: The Department also seeks
comment on whether the term ``medical treatment'' adequately
encompasses the range of services that should be covered under this
nondiscrimination provision.
Sec. 84.57 Value Assessment Methods
The proposed rule seeks to address discrimination on the basis of
disability in the use of value assessment methods. The Department has
been aware of potential disability discrimination in value assessment
for some time. For example, in 1992, the Department declined to
authorize a demonstration program in Oregon that relied on the use of
the Quality Adjusted Life Year (QALY), one specific methodology of
value assessment whose application in Oregon (and common application
elsewhere in the present day) discounted the value of life extension on
the basis of disability, to determine whether certain treatments for
people living with certain disabilities would be covered. The
Department cited concerns of discrimination in value assessment methods
in its response, stating that ``Oregon's plan in substantial part
values the life of an individual with a disability less than the life
of an individual without a disability. This premise is discriminatory
and inconsistent with the Americans with Disabilities Act.'' \138\ The
Department further noted that this discrimination and inconsistency
stemmed, in part, from the approach that ``quantifies stereotypic
assumptions about persons with disabilities.'' \139\ In 2010, Congress
prohibited the use of the QALY in Medicare \140\ and within the Patient
Centered Outcomes Research Institute created by the ACA.\141\ Many
disability rights advocates have expressed concerns about disability
discrimination in value assessment methods.\142\
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\138\ Letter from Louis Sullivan, Sec'y, U.S. Dep't of Health
and Human Servs., to Barbara Roberts, Governor, State of Or. (Aug.
3,1992), reprinted in 1992 CCH Medicare-Medicaid Guide New Devs.
40,406A, HHS Papers Explaining Rejection of Oregon Medicaid Waiver,
HHS News Release, Secretarial Letter, and Analysis (Aug. 3, 1992)
(the waiver was later approved after significant modification).
\139\ Id.
\140\ 42 U.S.C. 1320e-1(c)(1). In addition, recent legislation
has been introduced in the House of Representatives to ban the use
of QALYs outright in federally funded health programs. See
Protecting Health Care for All Patients Act of 2023, H.R. 485, 118th
Congress (2023) (Report No. 118-65, Part I).
\141\ 42 U.S.C. 1320e-1(e).
\142\ See NCIL Resolution Opposing the Use of QALYs (Quality-
Adjusted Life Years), Not Dead Yet, <a href="http://notdeadyet.org/ncil-resolution-opposing-the-use-of-qalys-quality-adjusted-life-years">http://notdeadyet.org/ncil-resolution-opposing-the-use-of-qalys-quality-adjusted-life-years</a>
(last visited May 22, 2023) (Not Dead Yet and the Autistic Self-
Advocacy Network joined in the resolution); see also Not Dead Yet,
NCIL Membership Adopts Resolution Opposing Health Insurers' Use of
QALYs (2020), <a href="https://notdeadyet.org/2020/08/ncil-membership-adopts-resolution-opposing-health-insurers-use-of-qalys.html">https://notdeadyet.org/2020/08/ncil-membership-adopts-resolution-opposing-health-insurers-use-of-qalys.html</a>; Disability
Rts. Educ. and Def. Fund (DREDF), Pharmaceutical Analyses Based on
the QALY Violate Disability Nondiscrimination Law (Sept. 21, 2021),
<a href="https://dredf.org/2021/09/23/pharmaceutical-analyses-based-on-the-qaly-violate-disability-nondiscrimination-law/">https://dredf.org/2021/09/23/pharmaceutical-analyses-based-on-the-qaly-violate-disability-nondiscrimination-law/</a> (``[T]he QALY relies
on a set of discriminatory assumptions that devalue life with a
disability, disadvantaging people with disabilities seeking to
access care based on subjective assessments of quality of life.'');
Lives Worth Living: Addressing the Fentanyl Crisis, Protecting
Critical Lifelines, and Combatting Discrimination Against Those with
Disabilities: Hearing on H.R. 467, H.R. 498, H.R. 501, and H.R. 485
Before the Subcomm. on Health of the H. Comm. on Energy and
Commerce, 118th Cong. (2023) (statement of Kandi Pickard, President
& CEO, Nat'l Down Syndrome Society), <a href="https://d1dth6e84htgma.cloudfront.net/Witness_Testimony_Pickard_HE_02_01_2023_065c903370.pdf?updated_at=2023-01-30T21:38:38.787Z">https://d1dth6e84htgma.cloudfront.net/Witness_Testimony_Pickard_HE_02_01_2023_065c903370.pdf?updated_at=2023-01-30T21:38:38.787Z</a> (speaking on her support of Protecting Health
Care for All Patients Act, H.R. 485, 118th Cong. (2023)). As
discussed elsewhere in this preamble section, value assessment
methods that may be discriminatory when used to determine people
with disabilities' access to goods and services may not be
discriminatory in another context (i.e., their use purely for
academic research). Some general statements about QALY, such as the
one quoted in this footnote, do not distinguish between various
types of QALY calculations or uses of the concept.
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Despite this prior history, value assessment methods have been
increasingly used by recipients to determine the cost-effectiveness of
goods and services. These determinations can inform price negotiations,
value-based purchasing arrangements that link provider payment to
performance and outcomes, and other things that affect the degree to
which individuals can access aids, benefits, or services, as well as
the terms or conditions under which they can access them.
Not all methods of value assessment or their uses are
discriminatory. Many value assessment methods can play an important
role in cost containment and quality improvement efforts. However, the
Department is concerned that some value assessment frameworks that have
been adopted by recipients may discriminate on the basis of disability,
in violation of existing prohibitions against such discrimination in
health services.\143\ In this rulemaking, the Department seeks to
explicitly apply these obligations to the use of value assessment
methods and provide relevant information for recipients on their
application. The Department has focused on methods that discount the
value of life extension for people with disabilities in this proposed
rule, as the vast majority of documentation of disability
discrimination concerns in value assessment have focused on the
discounting of life extension.\144\
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\143\ See 45 CFR 84.52(a).
\144\ See, e.g., Disability Rts. Educ. & Def. Fund (DREDF),
Pharmaceutical Analyses Based on the QALY Violate Disability
Nondiscrimination Law (2021), <a href="https://dredf.org/wp-content/uploads/2021/09/ICER-Analyses-Based-on-the-QALY-Violate-Disability-Nondiscrimination-Law-9-17-2021.pdf">https://dredf.org/wp-content/uploads/2021/09/ICER-Analyses-Based-on-the-QALY-Violate-Disability-Nondiscrimination-Law-9-17-2021.pdf</a>.
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Where value assessments use methods for calculating value that
place a lower value on life extension for a group of individuals based
on disability and where such methods are then used to
[[Page 63410]]
deny or afford an unequal opportunity to qualified individuals with
disabilities with respect to the eligibility or referral for, or
provision or withdrawal of an aid, benefit, or service, a recipient
using such value assessment methods for these purposes is in violation
of section 504. For example, a recipient that uses a value assessment
method that assigns a greater value to extending the life of people
without disabilities than to extending the life of people with
disabilities to determine whether a particular drug will be subject to
additional utilization management controls or placed on a higher tier
of a formulary would likely violate section 504. The recipient is using
a value assessment that assigns a greater value to extending the life
of people without disabilities with respect to the eligibility or
referral for, or provision or withdrawal of an aid, benefit, or
service--in this instance, to determine the terms or conditions under
which they are made available.
An analysis from the Institute for Clinical and Economic Review
(ICER)--whose work is often used to inform decision-making by
recipients--valued a year of life of a person with multiple sclerosis
with a score of eight on the Expanded Disability Status Scale
(describing an individual who relies entirely on a wheelchair for
mobility but is nonetheless able to be out of bed for much of the day
\145\) at 0.0211, representing approximately a 98% reduction in value
relative to a year of life for a healthy, nondisabled person.\146\
Similarly, another report from ICER valued a year of life with cystic
fibrosis with a ppFEV1 (percent predicted forced expiratory volume in
one second, an established measure of lung function for cystic
fibrosis) between 20-29% at 0.653, representing a 34.7% reduction in
value relative to a year of life for a healthy, nondisabled
individual.\147\ When a recipient uses these life extension valuations
with respect to determining eligibility or referral for, or provision
or withdrawal of any aid, benefit, or service, including the terms or
conditions under which they are made available, it ascribes a lower
value to extending the lives of people with specific disabilities
relative to extending those without disabilities or with other
disabilities.
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\145\ Kurtzke Expanded Disability Status Scale (EDSS), Nat'l
Multiple Sclerosis Soc'y, <a href="http://www.nationalmssociety.org/nationalmssociety/media/msnationalfiles/brochures/10-2-3-29-edss_form.pdf">http://www.nationalmssociety.org/nationalmssociety/media/msnationalfiles/brochures/10-2-3-29-edss_form.pdf</a> (last visited May 22, 2023).
\146\ Inst. for Clinical & Econ. Rev., Siponimod for the
Treatment of Secondary Progressive Multiple Sclerosis: Effectiveness
and Value, Final Evidence Report, p. 52 (2019), <a href="https://icer.org/wp-content/uploads/2020/10/ICER_MS_Final_Evidence_Report_062019.pdf">https://icer.org/wp-content/uploads/2020/10/ICER_MS_Final_Evidence_Report_062019.pdf</a>
(citing Annie Hawton & Colin Green, Health Utilities for Multiple
Sclerosis, 19 Value Health 460-468 (2016)).
\147\ Michael S. Schechter et al., Inhaled Aztreonam Versus
Inhaled Tobramycin in Cystic Fibrosis: An Economic Valuation. 12
Annals of the Am. Thoracic Soc'y 1030-38 (2015); Inst. for Clinical
& Econ. Rev., Modular Treatments for Cystic Fibrosis: Effectiveness
and Value: Final Evidence Report and Meeting Summary, p. 66 (2020),
<a href="https://icer.org/wp-content/uploads/2020/08/ICER_CF_Final_Report_092320.pdf">https://icer.org/wp-content/uploads/2020/08/ICER_CF_Final_Report_092320.pdf</a>.
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This remains the case even if the value of extending the lives of
people with disabilities is compared to a less discounted population
rather than a hypothetical non-disabled, healthy adult. For example, a
value assessment calculation using a general population average utility
of 0.816 for life extension for persons without cystic fibrosis and a
utility of 0.653 for life extension for persons with cystic fibrosis
would still assign lower value to extending the lives of persons with
cystic fibrosis relative to persons without. The outcome remains the
same even if the general population was also receiving a less severe
discount to the value of life extension.
Recipients often rely on value assessments to make decisions
regarding coverage, cost, and other decisions with serious implications
for access for individuals with disabilities. Relying on a measure that
discounts the value of extending the lives of people with disabilities
relative to people without disabilities raises serious concerns in
light of the consequences for access for individuals with disabilities.
It is important that recipients do not engage in discriminatory uses of
value assessment methods.
In its report, ``Quality-Adjusted Life Years and the Devaluation of
Life with Disability,'' NCD discussed the way that the QALY places a
lower value on extending the lives of individuals with disabilities and
chronic illnesses.\148\ NCD notes that a variety of alternative
nondiscriminatory methods exist, and provided examples. The Department
declines to endorse any specific method in this rulemaking. NCD noted
that many payers, including those who receive Federal financial
assistance such as State Medicaid agencies, have made use of or planned
to make use of value assessments in a discriminatory fashion in order
to evaluate particular health care interventions.\149\ For example, in
April 2018, one State's Medicaid Drug Utilization Review Board made use
of a $150,000 per QALY threshold for valuing a treatment for cystic
fibrosis, calculated based on an analysis that assigned a lower value
to extending the lives of persons with cystic fibrosis than persons
without cystic fibrosis.\150\
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\148\ Nat'l Council on Disability, Quality-Adjusted Life Years
and the Devaluation of Life with Disability, p. 39 (2019), <a href="https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf">https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf</a>. The NCD Report stated:
``By favoring those with no functional impairments, the protocols
implicitly endorse the belief that the lives of individuals without
disabilities are more valuable than that of their unfortunate
counterparts'' (citing Wendy Hensel et al., Playing God: The
Legality of Plans Denying Scarce Resources to People with
Disabilities in Public Health Emergencies, 63 Fla. L. Rev. 755
(2011)). Note that the discussion of QALY in the NCD report applies
to uses of QALY associated with life extension, not to other uses of
value assessment that assess effects of a health care intervention
on quality of life without discounting the value of life-extension.
The concern articulated in the report does not apply to the latter
use case.
\149\ Nat'l Council on Disability, Quality-Adjusted Life Years
and the Devaluation of Life with Disability, 13-14 (2019), <a href="https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf">https://ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf</a>.
\150\ N.Y. State Dep't of Health, N.Y. State Medicaid Drug
Utilization Review (DUR) Board Meeting Summary (Apr. 26, 2018),
<a href="https://www.health.ny.gov/health_care/medicaid/program/dur/meetings/2018/04/summary_durb.pdf">https://www.health.ny.gov/health_care/medicaid/program/dur/meetings/2018/04/summary_durb.pdf</a>.
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For the reasons discussed above, the Department proposes to add
Sec. 84.57 on value assessment methods, indicating that a recipient
shall not, directly or through contractual, licensing, or other
arrangements, use any measure, assessment, or tool that discounts the
value of life extension on the basis of disability to deny or afford an
unequal opportunity to qualified individuals with disabilities with
respect to the eligibility or referral for, or provision or withdrawal
of any aid, benefit, or service, including the terms or conditions
under which they are made available. The proposed provision does not
identify the use of any specific method of value assessment but instead
prohibits measures that discount the value of life extension on the
basis of disability when used to deny or provide an unequal opportunity
for a qualified person with a disability to participate in or benefit
from an aid, benefit, or service.
We note that the discriminatory use of a measure by a recipient
constitutes a violation of this provision, not necessarily that the
measure itself does. The use of such a measure in a discriminatory
fashion could come about through a variety of mechanisms, including,
but not limited to: (1) the use of a threshold that uses such a measure
(such as a cost-per-QALY threshold) for purposes of determining
coverage or the imposition of additional terms or conditions for
availability of a intervention, (2) the use of such a measure for
ranking interventions relative to each other within or between disease
categories, or (3) otherwise making use of such analyses to inform
reimbursement or utilization
[[Page 63411]]
management decisions even if they are not by themselves dispositive. In
contrast, the proposed provision would permit the use of such measures
that were not used to deny or afford an unequal opportunity to
qualified individuals with disabilities with respect to the eligibility
or referral for, or provision or withdrawal of an aid, benefit, or
service; for example, in academic research. Accordingly, the use of a
methodology that is discriminatory when applied to determine
eligibility, referral for, or provision or withdrawal of an aid,
benefit, or service would not be discriminatory if used in academic
research to assess the relative contribution of different policy
changes or medical innovations on national or global population health.
However, a recipient who makes use of such academic research for
purposes of determining eligibility, referral for, or provision or
withdrawal of an aid, benefit, or service may still violate section 504
if the use of the methodology employed within the research product is
discriminatory when applied in the new context.
Similarly, elements of value assessment methods that are
discriminatory in some contexts--such as for valuing life extension--
may not be discriminatory in other contexts. For example, the use of
utility weights for valuing quality of life improvements can be used in
a way that is not discriminatory, even if the use of the same utility
weights to discount life extension would be discriminatory, if used to
restrict or limit access by people with disabilities. For example, if
recipients use a measure of value that does not discount the value of
life extension on the basis of disability but does use utility weights
for valuing quality of life improvements from a treatment in a way that
is not discriminatory, such use of utility weights for assessing
quality of life improvements likely would not violate this provision.
However, using a measure that does discount life-extension to restrict
or limit access could violate the proposed provision.
<bullet> Value Assessment Methods Question 1: The Department seeks
comment on how value assessment tools and methods may provide unequal
opportunities to individuals with disabilities.
<bullet> Value Assessment Methods Question 2: The Department seeks
comment on other types of disability discrimination in value assessment
not already specifically addressed within the proposed rulemaking.
<bullet> Value Assessment Methods Question 3: The proposed value
assessment provision applies specifically to contexts in which
eligibility, referral for, or provision or withdrawal of an aid,
benefit, or service is being determined. The preamble discussion of the
provision clarifies that the provision would not apply to academic
research alone. However, the Department seeks comment on the extent to
which, despite this intended specificity, the provision would have a
chilling effect on academic research.
Sec. 84.60 Children, Parents, Caregivers, Foster Parents, and
Prospective Parents With Disabilities in the Child Welfare System
Children, parents, caregivers, foster parents, and prospective
parents with disabilities may encounter a wide range of discriminatory
barriers when accessing critical child welfare programs and services
that are designed to protect children and strengthen families. These
barriers arise in a variety of contexts, including parent-child
reunification services; policies or practices that discourage and/or
prohibit parents from receiving assistance with childcare
responsibilities from professional and natural supports; and safety and
risk assessment policies that conflate disability with parental
unfitness.
Federally funded child welfare programs and activities are covered
social service programs under section 504. As such, the children with
disabilities served by the child welfare system, as well as parents,
caregivers, foster parents, and prospective parents with disabilities,
are within the class of individuals with disabilities to whom section
504 protections extend. The Department proposes to add a new Sec.
84.60 to the section 504 regulation that will more clearly apply the
nondiscrimination requirements of section 504, which are consistent
with and reflect the requirements of the ADA, to child welfare programs
and activities. Additionally, the proposed section adds specific
regulatory provisions that illustrate the types of child welfare
actions that are prohibited discrimination under section 504.
A 2012 NCD report, ``Rocking the Cradle: Ensuring the Rights of
Parents with Disabilities and Their Children,'' \151\ found that
parents with disabilities involved in the child welfare system have
experienced disproportionately higher rates of child removals than
nondisabled parents \152\ and are often presumed to be unfit because of
their disabilities.\153\ Parents with disabilities have also been
inappropriately referred to ``one size fits all'' reunification
services.\154\ Some jurisdictions, where State law has explicitly
allowed courts to consider whether the presence of a disability makes a
parent unable to discharge their responsibilities, have denied disabled
parents access to reunification services. For example, as of 2015, 33
states' statutes expressly included a parent's disability as an
aggravated circumstance \155\ that allows a court to bypass the
reunification process by deeming that the disability makes the parent
unlikely to benefit from reunification services.\156\ While most State
laws do not allow for an automatic disqualification based on
disability, the inclusion of disability as an aggravating circumstance
invites unfounded presumptions by the courts and administering State
agencies that disability in and of itself, can be disqualifying.
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\151\ Nat'l Council on Disability, Rocking the Cradle: Ensuring
the Rights of Parents with Disabilities and Their Children (Sept.
27, 2012), <a href="http://www.ncd.gov/publications/2012/Sep272012/">www.ncd.gov/publications/2012/Sep272012/</a>.
\152\ Id. at 77-78.
\153\ Id. at 94.
\154\ Id. at 89.
\155\ See 42 U.S.C. 671(a)(15)(D)(i). States are not required to
provide assistance or services to prevent removal or reunify
children when the parent has subjected a child to aggravated
circumstances as defined by State law.
\156\ Nat'l Council on Disability, supra note 152 at 91. See
also Traci LaLiberte et al., Child Protection Services and Parents
with Intellectual and Developmental Disabilities, 30 J. Appl. Res
Intellectual Disability, 30: 521-532 (2017), <a href="https://pubmed.ncbi.nlm.nih.gov/28000335/">https://pubmed.ncbi.nlm.nih.gov/28000335/</a>.
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NCD's report provided case studies where children were removed from
parents based on the presumption of unfitness due to parental
disability. The report includes ten case studies of parents with
disabilities with firsthand experience with the child welfare system.
The studies provide examples of discriminatory barriers and bias
parents with disabilities encounter at key decision points in the child
welfare system, including reporting for abuse and neglect, safety and
risk assessments, case opening, and permanency decision. One study
described the experience of a couple who were presumed to be unfit to
care for their two-day-old daughter because both parents were blind.
The concerns centered on the parents' visual impairments, the mother's
unsuccessful first attempts at breastfeeding, and the parents' lack of
specialized parenting training. The infant was held in state custody
for 57 days until a court dismissed the child protective action against
the parents.\157\
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\157\ Id. at 94.
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Another case study described the experience of a mother with
intellectual disabilities who lived in supported
[[Page 63412]]
housing with her five-year-old daughter and received ongoing parent-
child intervention services. As a result of Intelligence Quotient (IQ)
testing, social workers convinced the mother to allow visits between
her daughter and her estranged nondisabled father, despite the mother's
reluctance.\158\ Social workers insisted that visits with the father
continue even after the mother reported that her daughter was afraid of
the father and had suddenly started wetting herself. The visits
terminated after a police investigation and medical examination
substantiated allegations of sexual abuse by the father, though the
social workers still questioned the mother's parenting ability.\159\
The experience of this mother and daughter is an example of how
negative assumptions about IQ as an indicator of parenting skills
served as a basis to question the mother's ability to safely care for
and protect her daughter.
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\158\ Id. at 97.
\159\ Id. at 97.
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In examining the use of IQ scores to determine a parent's capacity
or fitness to safely care for a child, NCD found that, particularly for
parents with intellectual disabilities, reliance on the tests results
in high rates of removal and loss of child custody. These tests
continue to be administered for the purpose of child custody planning
despite the research evidence demonstrating that parental IQ is a poor
predictor of parenting competence.\160\ When norm-referenced
assessments are used, (e.g., measures or assessments that compare a
person's knowledge or skills to the knowledge or skills of a group
considered to be normal), the parenting practices and behaviors of
parents with intellectual disability are ``judged subnormal and
inadequate rather than simply different.'' \161\ IQ tests are some of
the best-known examples of such norm-referenced assessments. NCD also
found that ``sole reliance on the IQ, resulting in diagnosis of
intellectual disability, leads to states having `bypass' statutes,' ''
where child removals may occur simply on a categorical or diagnostic
basis, without any individualized assessment or observation of
parenting.\162\ Similar to the NCD report, a 2017 review of appellate
court cases that culminated in termination of parental rights where
parents had intellectual and developmental disabilities found a
continued uncritical reliance on parental IQ to assess parental
fitness. The study found:
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\160\ Id. at 132 (citing David McConnell et al., Stereotypes,
Parents with Intellectual Disability and Child Protection, 24 J.
Soc. Welfare & Fam. L. 3, 297 (2002)).
\161\ Id.
\162\ Id. at 133 (citing Teresa Ostler, Assessment of Parenting
Competency in Mothers with Mental Illness, Univ. of Chicago (2008)).
[In] a majority of US cases involving a parent with intellectual
and developmental disabilities, appealing a termination of their
parental rights, parental IQ or intellectual functioning range often
was considered and relied upon by the court in upholding the
decision. The rate of reversal was far lower than the dependency and
general civil bench trial rates of reversal. It is worrying that
while every decision was reasoned differently, and all cases had
multiple issues, the courts consistently considered parental IQ,
rarely reviewed evaluation methods and results and frequently made
statements that reflected a view of parental IQ as static, fixed and
necessarily undermining of parenting capacity and ability to
learn.\163\
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\163\ Ella Callow et al., Judicial Reliance on Parental IQ in
Appellate-Level Child Welfare Cases Involving Parents with
Intellectual and Developmental Disabilities, 30 J. Appl. Res.
Intellectual Disabilities 553, 555-56 (2017).
Support for protecting the rights of parents, caregivers, foster
parents, and prospective parents with disabilities involved in the
child welfare system continues to gain momentum. In 2017, the American
Bar Association adopted a resolution urging Federal, State,
territorial, and tribal governments to enact legislation and implement
policies limiting the circumstances when a parent's disability could be
a basis for the denial of parental access to their child or termination
of parental rights, or when a prospective parent's disability could be
a bar in adoption and foster care.\164\ Seventeen states have enacted
laws prohibiting the use of parental disability as a basis for denial
or restriction of parenting responsibilities.\165\
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\164\ ``RESOLVED, That the American Bar Association urges all
federal, state, territorial, and tribal governments to enact
legislation and implement public policy providing that custody,
visitation, and access shall not be denied or restricted, nor shall
a child be removed or parental rights be terminated, based on a
parent's disability, absent a showing--supported by clear and
convincing evidence--that the disability is causally related to a
harm or an imminent risk of harm to the child that cannot be
alleviated with appropriate services, supports, and other reasonable
modifications . . . FURTHER RESOLVED, That the American Bar
Association urges all federal, state, territorial, and tribal
governments to enact legislation and implement public policy
providing that a prospective parent's disability shall not be a bar
to adoption or foster care when the adoption or foster care
placement is determined to be in the best interest of the child.''
Am. Bar Ass'n, ABA Policy Resolution 114: Disabled Parents and
Custody, Visitation, and Termination of Parental Rights, (Feb. 6,
2017), <a href="https://www.americanbar.org/content/dam/aba/administrative/commission-disability-rights/114.pdf">https://www.americanbar.org/content/dam/aba/administrative/commission-disability-rights/114.pdf</a>.
\165\ Heller Sch. for Soc. Pol'y and Mgmt., Brandeis U., NRCPD,
Map of Current State Legislation Supporting Parents with
Disabilities, <a href="https://heller.brandeis.edu/parents-with-disabilities/map/index.html">https://heller.brandeis.edu/parents-with-disabilities/map/index.html</a> (last updated (Oct. 9, 2020).), <a href="https://heller.brandeis.edu/parents-with-disabilities/map/index.html">https://heller.brandeis.edu/parents-with-disabilities/map/index.html</a>).
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OCR has received over 300 complaints alleging disability
discrimination in child welfare services and activities within the last
six years. The complaints allege discrimination in a wide range of
child welfare services that are subject to nondiscrimination
requirements including: child protection investigations; child and
family assessments; case plan development; parent-child visitation;
child placement decision-making; provision of community-based services;
foster and adoptive parent assessments; and determinations to terminate
parent-child reunification efforts. OCR's investigations have revealed
that some child welfare entities have implemented policies, practices,
and procedures that contribute to unnecessary removals of children from
parents with disabilities and create barriers to parent-child
reunification, permanency planning, and other critical child welfare
services. Additionally, as discussed later in this section, OCR has
investigated complaints of discrimination against children with
disabilities in the child welfare system. As a result of these
investigations, child welfare entities and OCR have worked t together
to establish Voluntary Resolution Agreements (VRA), some of which are
discussed in greater detail below, required child welfare agencies to
create, revise, establish, and implement policies, practices, and
procedures to prohibit discrimination against parents with disabilities
and ensure that the full range of agency programs are accessible to
parents with physical and mental disabilities as required by section
504 and title II. These complaints and VRAs are consistent with the
2012 NCD report finding that the ``child welfare system is ill-equipped
to support parents with disabilities and their families.'' \166\
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\166\ Nat'l Council on Disability, supra note 152 at 18.
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According to data submitted to the Administration for Children and
Families (ACF) through its Adoption and Foster Care Analysis and
Reporting System (AFCARS) as reported in November 2021, more than
216,838 children entered the U.S. foster care system due at least in
part to safety concerns related to parental fitness during 2020.\167\
Thirteen percent, or
[[Page 63413]]
28,771 children, were removed from a parent or caregiver based, in
part, on ``Caretaker Inability to Cope Due to Illness or Other
Reasons'' as one of the circumstances associated with child's removal.
The AFCARS regulation defines ``caretaker inability to cope due to
illness or other reasons'' as a ``a physical or emotional illness, or
disabling condition adversely affecting the caretaker's ability to care
for the child.'' AFCARS submissions in 2020 on the ``Caretaker
Inability to Cope'' out-of-home case data element demonstrate that a
caretaker's physical illness, emotional illness, or disabling condition
continues to be a factor in child removals. Reporting on this data
element from 2015-2020 shows that title IV-E agencies removed fourteen
percent of children who entered the U.S. foster care system due in part
to safety concerns related to a caretaker's physical illness, emotional
illness, or disabling condition, i.e., concerns labeled ``Caretaker
Inability to Cope.''
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\167\ The Adoption and Foster Care Analysis and Reporting System
(AFCARS) collects case-level information on all children in foster
care and those who have been adopted with Title IV-E agency
involvement. See U.S. Dep't of Health & Hum. Servs., Admin. for
Children & Families, AFCARS Report # 28 (Nov. 19, 2021), <a href="https://www.acf.hhs.gov/cb/report/afcars-report-28">https://www.acf.hhs.gov/cb/report/afcars-report-28</a>.
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As noted by research published in Children and Youth Services
Review, in the 2012 AFCARS data, parental disability was the only
parental characteristic based on a parent's physical or mental
attributes categorized in State child welfare policies or in Federal
data collection tools as a consideration when determining whether to
remove a child from their home or to terminate parental rights.\168\ In
the AFCARS data, ``caretaker inability to cope is the only removal
reason that is a parental characteristic based on a physical or mental
condition rather than a changeable behavior.'' \169\ The data elements
reviewed remained in place through 2020.
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\168\ Sharon DeZelar et al., Use of Parent Disability as a
Removal Reason for Children in Foster Care in the U.S., 86 Children
& Youth Services Rev. 128-134 (2018).
\169\ E. Lightfoot, et al., Child well-being in Minnesota--
Policy strategies for Improving Child Welfare Services for Parents
With Disabilities and their Children (Child Welfare Policy Brief No.
10), Ctr. for Advanced Studies in Child Welfare, Univ. Minn. (Winter
2016).
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[…truncated; see source link]Indexed from Federal Register on September 14, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.