Discrimination on the Basis of Disability in Health and Human Service Programs or Activities

Federal RegisterSep 14, 2023

Ask Donna

What actually matters in this document.

Text

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.

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 Finally, the proposed rule would make other clarifying edits, including updating outdated terminology and references.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

https://www.zoomgov.com/meeting/register/vJIsceGqpzsjEwi5AQ8pvdIholm7Xp4hwLs.

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

http://www.regulations.gov

by searching for the Docket ID number HHS-OCR-2023-0013. Follow the instructions at

http://www.regulations.gov

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

http://www.regulations.gov,

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

http://www.regulations.gov

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

504@hhs.gov.

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 (§ 84.56)

Value Assessment Methods (§ 84.57)

Children, Parents, Caregivers, Foster Parents, and Prospective Parents in the Child Welfare System (§ 84.60)

Subpart I: Web, Mobile, and Kiosk Accessibility (§§ 80.82-80.88)

Subpart J: Accessible Medical Equipment (§§ 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 (§ 84.1): Revisions to Subpart A

Application (§ 84.2): Revisions to Subpart A

Relationship to Other Laws (§ 84.3): Revisions to Subpart A

Definition of Disability (§ 84.4): Revisions to Subpart A

Notice (§ 84.8): Revisions to Subpart A

Definitions (§ 84.10): Revisions to Subpart A

Employment Practices (§ 84.16): Revisions to Subpart B

Program Accessibility (§§ 84.21-84.23): Revisions to Subpart C

Childcare, Preschool, Elementary and Secondary, and Adult Education (§§ 84.31, 84.38): Revisions to Subpart D

Health, Welfare, and Social Services (§§ 84.51-84.55): Revisions to Subpart F

Subpart G: General Requirements

General Prohibitions Against Discrimination (§ 84.68)

Illegal Use of Drugs (§ 84.69)

Maintenance of Accessible Features (§ 84.70)

Retaliation or Coercion (§ 84.71)

Personal Services and Devices (§ 84.72)

Service Animals (§ 84.73)

Mobility Devices (§ 84.74)

Direct Threat (§ 84.75)

Integration (§ 84.76)

Subpart H: Communications (§§ 84.77-84.81)

Subpart K: Procedures (§ 84.98)

IV. Executive Order 12866 and Related Executive Orders on Regulatory Review

Regulatory Impact Analysis Summary

Regulatory Flexibility Act—Initial Small Entity Analysis

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

that receive Federal financial assistance as well as in programs and activities conducted by any Federal agency.

Section 504 provides:

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).

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.

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.

OCR also enforces section 1557 (section 1557) of the Patient Protection and Affordable Care Act (ACA),

which prohibits discrimination on various bases including disability in any health program or activity, any part of which receives Federal financial assistance, including credits, subsidies, or 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.

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.

42 U.S.C. 18116.

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.

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.

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).

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.

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).

45 CFR pt. 85.

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.

The

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.

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.

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.

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

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.

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.

That discrimination contributes to significant health disparities and poorer health outcomes than persons with disabilities would experience absent the discrimination.

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),

https://doi.org/10.1007/s40615-016-0220-5;

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),

https://doi.org/10.1016/j.dhjo.2014.11.002;

Lisa I. Iezzoni et al.,

Have Almost Fifty Years of Disability Civil Rights Laws Achieved Equitable Care?,

41 Health Affairs 1371 (2022),

https://doi.org/10.1377/hlthaff.2022.00413;

Tara Lagu et al.,

`I Am Not The Doctor For You': Physicians' Attitudes About Caring For People With Disabilities,

41 Health Affairs 1387 (2022),

https://doi.org/10.1377/hlthaff.2022.00475;

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),

https://doi.org/10.1377/hlthaff.2022.00499.

Nat'l Council on Disability, Health Equity Framework for People With Disabilities (2022),

https://www.ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf;

Nat'l Council on Disability, The Current State of Health Care for People with Disabilities (2009).

See, e.g.,

Nat'l Council on Disability, Bioethics and Disability Report Series (2019),

https://ncd.gov/publications/2019/bioethics-report-series;

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),

http://www.newmobility.com/equal-health-care-if-not-now-when;

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).

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.”

Research in the field of health care supports this assertion.

One recent study demonstrates that large proportions of practicing U.S. physicians appear to hold biased or stigmatized perceptions of people with disabilities.

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.

Flawed perceptions, stereotypes, and biases about individuals with disabilities can lead to prohibited discrimination.

Nat'l Council on Disability, Assisted Suicide: A Disability Perspective (Mar. 24, 1997),

https://ncd.gov/publications/1997/03241997.

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,

https://doi.org/10.1542/peds.2022-060975.

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),

https://doi.org/10.1377/hlthaff.2022.00475;

Laura VanPuymbrouck et al.,

Explicit and Implicit Disability Attitudes of Healthcare Providers,

Rehabilitation Psych., 65(2) 2020, at 101-112,

https://doi.org/10.1037/rep0000317.

Lisa I. Iezzoni et al.,

Physicians' Perceptions of People with Disability and their Health Care,

40 Health Aff. 297 (Feb. 2021),

https://pubmed.ncbi.nlm.nih.gov/33523739/

(citing GL Albrecht et al.,

The Disability Paradox: High Quality of Life Against All Odds,

48 Soc. Sci. Med., 977 (1999)).

See, e.g., Lesley

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”).

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.

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.

Nat'l Council on Disability, Rocking the Cradle: Ensuring the Rights of Parents with Disabilities and their Children (2012),

https://www.ncd.gov/sites/default/files/Documents/NCD_Parenting_508_0.pdf.

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

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 § 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.

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.”

See, e.g., Donlon

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

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

N.H. Dep't of Corr.,

151 F.3d 274, 285 (1st Cir. 2006);

Sumes

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

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).

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),

https://ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr.

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 § 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.

People with disabilities have reduced access to medical treatment, a reality that leads to significant health disparities and poorer health outcomes.

People with disabilities are significantly more likely than people without disabilities to have unmet medical, dental, and prescription needs.

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.

People with certain types of serious mental illness have a significantly shorter life expectancy than the general population,

and people with mental illness have an increased risk of physical disease, as well as reduced access to adequate health care.

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

death than people without disabilities.

People with physical disabilities are less likely to receive mammograms, Pap smears, or other recommended routine preventive screenings.

People with disabilities are also more likely to have risk factors associated with cancer than people without disabilities.

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.

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.

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,

https://www.cdc.gov/ncbddd/disabilityandhealth/materials/infographic-disabilities-ethnicity-race.html

(last visited Oct. 1, 2022).

See, e.g.,

Nat'l Council on Disability, Bioethics and Disability Report Series (2019),

https://ncd.gov/publications/2019/bioethics-report-series;

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),

http://www.newmobility.com/equal-health-care-if-not-now-when;

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).

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),

https://doi.org/10.1016/j.dhjo.2014.08.007;

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).

Ctrs. for Disease Control & Prevention,

Disability Inclusion, https://www.cdc.gov/ncbddd/disabilityandhealth/disability-inclusion.html;

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),

https://pubmed.ncbi.nlm.nih.gov/25719432;

Williams, M. et al.,

Exploring Health Disparities Among Individuals with Disabilities within the United States,

Am. Pub. Health Ass'n. (Oct. 2020),

https://apha.confex.com/apha/2020/meetingapp.cgi/Paper/473208;

Nat'l Council on Disability, Health Equity Framework for People with Disabilities (2022),

https://ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf.

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).

https://doi.org/10.1186/s12991-021-00374-y;

Steve Brown et al.,

Twenty Five Year Mortality of a Community Cohort with Schizophrenia,

Br. J. Psychiatry (2010),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4560167/.

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),

https://doi.org/10.1016/S2215-0366(19)30132-4.

See, e.g.,

Jessica L. Gleason et al.,

Risk of Adverse Maternal Outcomes in Pregnant Women with Disabilities,

JAMA Network Open (2021),

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787181; Willi Horner-Johnson et al., Perinatal Health Risks and Outcomes Among US Women with Self-Reported Disability,

41 Health Aff. 2011 (Sep. 2022),

https://doi.org/10.1377/hlthaff.2022.00497.

Lisa Iezzoni et al.,

Associations Between Disability and Breast or Cervical Cancers, Accounting for Screening Disparities,

Medical Care 139 (2021),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855335/; see also,

C. Brook Steele et al.,

Prevalence of Cancer Screening Among Adults with Disabilities,

United States, 2013. Preventing Chronic Disease (2017),

http://dx.doi.org/10.5888/pcd14.160312.

M.A. Nosek et al.,

Breast and Cervical Cancer Screening Among Women with Physical Disabilities,

78 Archives of Physical Medicine and Rehabilitation, S39 (1997),

https://doi.org/10.1016/s0003-9993(97)90220-3; See also,

Lisa Iezzoni,

Cancer Detection, Diagnosis, and Treatment for Adults with Disabilities,

23 Lancet E164 (Apr. 2022),

https://doi.org/10.1016/S1470-2045(22)00018-3.

Nat'l Council on Disability, The Impact of COVID-19 on People with Disabilities, 87 (2021),

https://ncd.gov/sites/default/files/NCD_COVID-19_Progress_Report_508.pdf.

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),

https://doi.org/10.1377/hlthaff.2022.00509.

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.”

Nat'l Acad. of Sciences, Engineering, & Med.,

People Living with Disabilities: Health Equity, Health Disparities, and Health Literacy: Proceedings of a Workshop

(2018),

https://doi.org/10.17226/24741.

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.

The study showed that, for example, 82% of doctors thought people with disabilities had a lower quality of life than people without disabilities,

only 40% felt confident in their ability to provide the same level to care to patients with disabilities as those without disabilities,

and only 56% strongly agreed that they welcomed patients with disabilities into their practice.

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.

For example, more than 71% of physicians surveyed provided incorrect answers about who makes decisions about reasonable accommodations for patients with a disability.

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.

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.”

Most individuals with disabilities report an excellent or good quality of life.

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.”

Lisa I. Iezzoni et al.,

Physicians' Perceptions of People with Disability and Their Health Care,

40 Health Aff. 297 (Feb. 2021),

https://pubmed.ncbi.nlm.nih.gov/33523739/.

Id.

at 300.

Id.

at 301.

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),

https://pubmed.ncbi.nlm.nih.gov/34982624/.

Id.

at 100-101.

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),

https://doi.org/10.1377/hlthaff.2022.00475.

Nat'l Council on Disability, Medical Futility and Disability Bias (2019),

https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf; see also,

Mary Crossley,

Ending-Life Decisions: Some Disability Perspectives,

33 Ga. St. U. L. Rev. 900 (2017).

Lisa I. Iezzoni et al.,

Physicians' Perceptions of People with Disability and their Health Care,

40 Health Aff. 297 (Feb. 2021),

https://pubmed.ncbi.nlm.nih.gov/33523739/

(citing GL Albrecht et al,

The Disability Paradox: High Quality of life against all odds,

48 Soc. Sci. Med. 977 (1999)).

Nat'l Council on Disability, Assisted Suicide: A Disability Perspective (1997),

https://ncd.gov/publications/1997/03241997.

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.

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.

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.”).

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.

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.

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.

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 §§ 482.1 through 482.58.

Sec. 372, Public Law 98-507; 42 U.S.C. 274.

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)).

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.

In February 2022, NCD issued a “Health Equity Framework for People with Disabilities” and recommended that HHS regulate this area.

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.

Nat'l Council on Disability, Organ Transplants Discrimination against People with Disabilities: Part of the Bioethics and Disability Series (2019),

https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf.

Nat'l Council on Disability, Health Equity Framework for People with Disabilities (2022),

https://ncd.gov/sites/default/files/NCD_Health_Equity_Framework.pdf.

Nat'l Council on Disability, Organ Transplants Discrimination against People with Disabilities: Part of the Bioethics and Disability Series, 38-40 (2019),

https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf.

OCR's investigative experience confirms ongoing concerns about discrimination at various points in the transplant process. Medical providers and transplant programs continue to refuse to evaluate patients with disabilities who are otherwise qualified for transplant eligibility and fail to place qualified patients on transplant waiting lists because of exclusions and limitations for certain disabilities that are not supported by objective evidence or that do not take into account reasonable modifications in assessing an individual's ability to manage postoperative care needs and other aspects of transplantation.

For example, in 2019, OCR resolved a case alleging discrimination against an individual with autism spectrum disorder, in which the complainant alleged 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.

See, e.g., Bussoletti

Univ. of Pitt. Med. Ctr.

(07-068765);

Walker

Univ. Cal. San Diego Med. Ctr.

(08-80649);

Parsons

Cnty of Santa Clara, Santa Clara Valley Med. Ctr.

(07-69439);

Paladino

Union City Renal Ctr.

(06-44878);

Beaton

Sutter Mem'l Hosp.

(03-11505);

Eggemeyer

Ill. Dep't of Human Serv. Randolph Cnty. Office

(03-004371);

HIV/AIDS Legal Servs Alliance

Health Plan P of Cal.

(09-02-3296);

Lewis

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.

See Disability Rts. of N.C.

Univ. of N.C. Hosp.,

(19-318735),

https://www.hhs.gov/about/news/2019/02/12/ocr-resolves-disability-complaint-individual-who-was-denied-opportunity-heart-transplant-list.html

(No violation was found but a voluntary resolution agreement was entered into with the facility).

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.

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.

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.

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.

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.

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.

Nat'l Down Syndrome Soc'y,

Nondiscrimination in Organ Transplantation Laws & Toolkit

(2022),

https://www.ndss.org/programs/ndss-legislative-agenda/healthcare-research/nondiscrimination-in-organ-transplantation-laws-toolkit/.

Nat'l Council on Disability, Organ Transplant Discrimination Against People With Disabilities 53-54 (2019),

https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf; 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).

Research has documented the persistence of organ transplantation policies that discriminate against individuals with disabilities,

particularly against individuals with intellectual and developmental disabilities, psychiatric disabilities, and HIV.

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.

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.

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.

Nat'l Council on Disability, Organ Transplant Discrimination Against People With Disabilities, 30 (2019),

https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf

(“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.”).

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).

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).

Marilee A. Martens et al.,

Organ Transplantation, Organ Donation, and Mental Retardation,

10 Pediatric Transplantation 658 (2006).

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.”

Am. Soc'y of Transplant Surgeons,

Statement Concerning Eligibility for Solid Organ Transplant Candidacy

(Feb. 12, 2021),

https://asts.org/about-asts/position-statements#.Ysxi0LfMKUk.

Media reports have also documented denials of organ transplants based on disability.

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.

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.

In February 2022, CBS News covered families' allegations that hospitals denied transplant eligibility for children with Down syndrome and other developmental disabilities.

In addition, the general obligation to make reasonable modifications for qualified individuals with disabilities under proposed § 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.

See, e.g.,

Sara Reardon,

Push Is On for States to Ban Organ Transplant Discrimination,

Kaiser Health News (Mar. 8, 2021),

https://khn.org/news/article/organ-transplant-discrimination-disabilities-state-legislation/;

Sunshine Bodey,

My Son Has Autism. Discrimination Almost Cost Him His Life,

Wash. Post (Aug. 30, 2017),

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;

Lenny Berstein,

People with Autism, Intellectual Disabilities Fight Bias in Transplants,

Wash. Post (Mar. 4, 2017),

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.

Kim Painter,

Disabled NJ Girl Thrives, Inspires After Transplant,

USA Today (Oct. 5, 2013),

https://www.usatoday.com/story/news/nation/2013/10/05/disabled-transplant-amelia-rivera/2917989/.

David Shapiro,

Disabled Woman Dies While Awaiting Second Chance at Transplant,

NPR (June 13, 2012),

https://www.npr.org/sections/health-shots/2012/06/13/154914089/disabled-woman-dies-while-awaiting-second-chance-at-kidney-transplant.

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),

https://www.cbsnews.com/news/organ-transplants-discrimination-disability-rights.

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.

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.

Medical futility sometimes goes under other names such as “nonbeneficial treatment.”

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.

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.

As discussed above,

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).

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.

Nat`l Council on Disability, Medical Futility and Disability Bias: Part of the Bioethics and Disability Series (Nov. 2019),

https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf.

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),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/

(clarifying the continued use of these standards in the present day).

Lisa I. Iezzoni et al.,

Physicians' Perceptions of People with Disability and Their Health Care,

40 Health Aff. 297 (Feb. 2021),

https://pubmed.ncbi.nlm.nih.gov/33523739/,

citing GL Albrecht et al.,

The Disability Paradox: High Quality of Life Against All Odds,

48 Soc. Sci. Med. 977 (1999).

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.

For example, the idea that if treatment “cannot end dependence on intensive medical care, the treatment should be considered futile,”

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

or a patient's reliance on others for activities of daily living.

When these definitions are used to deny care to people with disabilities, they are likely to be discriminatory.

L. Morata,

An Evolutionary Concept Analysis of Futility in Health Care,

74 J. Advanced Nursing 1289 (June 2018).

Id.

L.J. Schneiderman et al.,

Medical Futility,

118 Handbook of Clinical Neurology 167 (Jan. 2013);

Morata L., supra

note 68.

R. Sibbald, et al.,

Perceptions of “Futile Care” Among Caregivers in Intensive Care Units,

177 CMAJ 1201 (Nov. 2007); Müller 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.

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 Ørtenblad 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.

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.

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.

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.

J.R. Curtis et al.,

Use of the Medical Futility Rationale in Do-Not-Attempt-Resuscitation Orders,

273 JAMA 124, 125 (1995).

Id. See also

Gary Albrecht et al.,

The Disability Paradox: High Quality of Life Against All Odds,

48 Soc Sci Med. 977 (Apr. 1999).

Maryam Aghabaray et al.,

Medical Futility and its Challenges: A Review Study,

9 J. of Med. Ethics and History of Med. 11 (2016),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/.

Nat'l Council on Disability, Medical Futility and Disability Bias, Part of the Bioethics and Disability Series (2019),

https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf;

Maryam Aghabaray et al.,

Medical Futility and its Challenges: A Review Study,

9 J. Med. Ethics & History of Med. 11 (2016),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5203684/;

Dominic J. Wilkinson et al.,

Knowing When to Stop: Futility in the Intensive Care Unit,

2 Current Op. in Anesthesiology 24 (2011),

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3252683/

(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.”

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).

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

than an assessment of the individual's ability to benefit from treatment.

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.

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.

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.

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.

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.

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.

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),

https://ncd.gov/publications/2019/ncd-letter-hhs-3-bioethics-reports;

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,

https://ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr;

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),

https://www.c-c-d.org/fichiers/Letter-re-COVID-19-and-Disability-Discrimination-final.pdf;

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),

https://chrissmith.house.gov/uploadedfiles/2020-03-25_bipartisan_bicameral_letter_to_hhs_and_doj_-_covid-19_and_disability_discrimination.pdf;

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)

https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf;

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)

https://www.warren.senate.gov/imo/media/doc/2020.04.09%20Letter%20to%20HHS%20OCR%20re%20Rationing%20of%20Care.pdf;

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),

https://www.aapd.com/press-releases/civil-rights-letter-covid-medical-rationing/?fbclid=IwAR0uKHogSaq8zknb--gVKL9-oplHXyX1a1lGpyx306WHpr0ZQWoxSk2C1oM;

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 Rationi

ng (Apr. 17, 2020),

https://www.aapd.com/press-releases/civil-rights-letter-covid-medical-rationing/?fbclid=IwAR0uKHogSaq8zknb--gVKL9-oplHXyX1a1lGpyx306WHpr0ZQWoxSk2C1oM;

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.

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.

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, lankford.senate.gov

(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),

https://www.ncd.gov/publications/2020/ncd-covid-19-letter-hhs-ocr.

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.

OCR resolved a number of civil rights complaints and provided technical assistance to recipients, including complaints against Tennessee,

Utah,

North Carolina,

several regional consortia of hospital systems within Texas,

and Arizona,

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.

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.

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),

https://www.hhs.gov/about/news/2020/06/26/ocr-resolves-complaint-tennessee-after-it-revises-its-triage-plans-protect-against-disability.html.

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),

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.

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),

https://www.hhs.gov/about/news/2021/01/14/ocr-provides-technical-assistance-ensure-crisis-standards-of-care-protect-against-age-disability-discrimination.html.

See id.

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),

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.

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),

https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html.

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

not futile for said individuals. Judgments of futility may not be based on criteria otherwise prohibited in this section or elsewhere in section 504.

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.

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),

https://doi.org/10.1215/03616878-9156005.

https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html.

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.

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.

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),

https://doi.org/10.17226/26479.

Recent research has documented that people with disabilities also face systemic and unnecessary exclusion from clinical research.

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.

Willyanne DeCormier Plosky et al.,

Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarity and Justification,

41 Health Aff. 10 (Jan. 2022).

https://doi.org/10.1377/hlthaff.2022.00520;

Katie McDonald et al.,

Eligibility criteria in NIH-funded Clinical Trials: Can Adults with Intellectual Disability Get In?

15 Disability & Health (2022),

https://doi.org/10.1016/j.dhjo.2022.101368.

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 § 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,

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.

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.

https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html.

See id.

at Question 7.

Id.

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

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.”

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.

Am. Acad. of Dev. Med. & Dentistry, People with Intellectual and Developmental Disabilities and the Allocation of Ventilators During the COVID-19 Pandemic (Apr. 2020),

https://static1.squarespace.com/static/5cf7d27396d7760001307a44/t/5ecfb6fff13530766aeae51a/1590671105171/Ventilator+-+Policy+Statement+w+Addendum.pdf.

The general requirement that recipients must provide reasonable modifications when necessary to avoid discrimination that appears in proposed § 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.

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),

https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/disabilty-faqs/index.html.

§ 84.56(a) Discrimination Prohibited

Proposed § 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 § 84.68(a), as well as the general prohibition that applies to health, welfare, and other social services in § 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.

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.

See Bragdon

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.

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.”

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

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

29 U.S.C. 794(b).

100

524 U.S. 206 (1998).

101

Id.

at 212 (internal quotation marks omitted).

Indeed, the Supreme Court has itself applied both section 504 and the ADA to medical treatment decisions. In

Bowen

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

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

102

476 U.S. 610, 624 (1986).

103

524 U.S. 624, 649 (1998).

Some lower Federal courts have questioned the manner and reach of section 504 as applied to medical treatment decisions. In

United States

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

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

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

Thompson,

971 F.2d 1487,1493 (10th Cir. 1992).

106

See, e.g., Schiavo ex rel. Schindler

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

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

Moore,

970 F.2d 1103, 1109 (2d Cir. 1992) (“[A]s we have observed in the past, we must be careful in applying § 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

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

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).

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 § 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 § 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 § 84.56(b)(2), the rule's application is relatively narrow but nonetheless is critical to prevent prohibited discrimination. Consistent with proposed § 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 § 84.56(c)(1)(ii) that providers do not make legitimate medical judgments when they base decisions on the criteria contained in § 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

109

See, e.g., Lesley

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

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.”).

Proposed § 84.56(b) elaborates on the basic requirement in § 84.56(a) by providing a non-exhaustive set of examples of conduct that would violate that requirement.

§ 84.56(b)(1) Denial of Medical Treatment

Proposed § 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

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 § 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 § 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

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

469 U.S. 287, 301 (1985).

School Board of Nassau County

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).

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, § 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 § 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 § 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

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 § 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.

§ 84.56(b)(2) Denial of Treatment for a Separate Symptom or Condition

Proposed § 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 § 84.56(b)(1)(iii) may also violate § 84.56(b)(2). For example, as described above in the discussion of § 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 § 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 § 84.56(b)(2) because of the denial of treatment of a separate condition.

As another example described above in the discussion of § 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 § 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, § 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.

•

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 § 84.56(b)(2).

These obligations must be interpreted in light of the rule of construction in proposed § 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.

§ 84.56(b)(3) Provision of Medical Treatment

Proposed § 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 § 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 § 84.56(b)(3) if the provider prescribes contraception for her other patients without disabilities. However, proposed § 84.56(b)(3) does not prohibit a recipient from providing

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 § 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

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

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),

https://nwlc.org/wp-content/uploads/2022/01/%C6%92.NWLC_SterilizationReport_2021.pdf

and the related Appendix,

https://nwlc.org/wp-content/uploads/2022/01/%C6%92.NWLC_SterilizationReport_2022_Appendix.pdf

(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.

•

Medical Treatment Question 2: The Department seeks comment on other examples of the discriminatory provision of medical treatment to people with disabilities

§ 84.56(c) Construction

Proposed § 84.56(c) sets forth a series of principles guiding how § 84.56 should be interpreted.

§ 84.56(c)(1) Professional Judgment in Treatment

Proposed § 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 § 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 § 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

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.

•

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.

§ 84.56(c)(2) Consent

Proposed § 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

American Hospital Association

that the denial of treatment to an individual because of a lack of consent to treatment “cannot violate § 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 § 504 includes an infant who is born with a congenital defect,” and that the statute protects qualified infants against disability-based discrimination in

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 § 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)

https://www.npr.org/2020/12/14/945056176/as-hospitals-fear-being-overwhelmed-by-covid-19-do-the-disabled-get-the-same-acc

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),

https://www.opb.org/news/article/law-bars-disability-discrimination-covid-19/

133

Nat'l Disability Rts. Network,

Devaluing People with Disabilities: Medical Procedures that Violate Civil Rights

(May 2012),

https://www.ndrn.org/wp-content/uploads/2012/05/Devaluing-People-with-Disabilities.pdf

134

Id.

at 17.

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 § 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

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),

https://ncd.gov/sites/default/files/NCD_Medical_Futility_Report_508.pdf

136

Id.

§ 84.56(c)(3) Providing Information

Proposed § 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 § 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 § 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),

https://www.ama-assn.org/system/files/2019-06/code-of-medical-ethics-chapter-2.pdf

The Department realizes that providing regulatory requirements concerning medical treatment requires careful consideration.

•

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

•

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

§ 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

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,

http://notdeadyet.org/ncil-resolution-opposing-the-use-of-qalys-quality-adjusted-life-years

(last visited May 22, 2023) (Not Dead Yet and the Autistic Self-Advocacy Network joined in the resolution);