DREDF Comments on the 2022 Section 1557 Proposed Rule on Nondiscrimination in Health Programs and Activities

October 3, 2022
Via electronic submission to www.regulations.gov

Melanie Fontes Rainer
Director
Office for Civil Rights
Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201

RE: Docket ID HHS-OS-2022-0012-0001, RIN 0945-AA17, Nondiscrimination in Health Programs and Activities

Dear Director Rainier,

Thank you for the opportunity to provide comments to the Department of Health and Human Services (HHS) and the Office for Civil Rights (OCR) on its Notice of Proposed Rulemaking on “Nondiscrimination in Health Programs and Activities” under Section 1557 of the Affordable Care Act (proposed rule). We appreciate the full 60-day public comment period provided upon the proposed rule’s publication in the Federal Register on August 4, 2022 given the importance of Section 1557’s nondiscrimination mandate to people with disabilities across the full range of our diverse community.

DREDF is a national cross-disability law and policy center that protects and advances the civil and human rights of people with disabilities through legal advocacy, training, education, and development of legislation and public policy. We are committed to increasing accessible and equally effective health care for people with disabilities and eliminating persistent health disparities that affect the length and quality of their lives. DREDF’s work is based on the knowledge that people with disabilities of varying racial and ethnic backgrounds, ages, genders, and sexual orientations are fully capable of achieving self-sufficiency and contributing to their communities with access to needed services and supports and the reasonable accommodations and modifications enshrined in U.S. law. Our interest in Section 1557 is both personal and professional. A majority of DREDF’s staff and its board are people with disabilities and/or the parents of children with disabilities. We purchase small group insurance for ourselves, and we serve people with disabilities who rely on Medicaid, Medicare, individual and small group insurance, private employment insurance, and sometimes a mixture of any two or three of public and private insurance. Nondiscrimination in the design, marketing, administration, and delivery of health insurance and health care allows us, as well as our constituents, to work and function in our daily lives and communities. We have written comments in response to HHS OCR’s prior 2013 Request for Information and it’s 2015 and 2019 Notices of Proposed Rulemaking for Section 1557. At times, we refer to those prior written comments below.

DREDF strongly supports the proposed rule. It clarifies and strengthens nondiscrimination protections for people with disabilities and other populations that have experienced systemic barriers to receiving equally effective health care. Below we provide a more detailed section-by-section analysis of how particular provisions in the proposed rule will benefit the health and well-being of our communities. We also provide our analysis and recommendations in response to requests for comment on specific topics that were raised in the preamble to the rule. These specific topics include adopting existing accessibility standards for medical and diagnostic equipment within the rule and increasing granular data collection as part of civil rights enforcement. Finally, we address several cross-cutting issues that include capturing Part B providers and health research within the scope of the proposed rule, the impact of the Dodds Supreme Court decision on people with disabilities, the use of Quality Adjusted Life Years to evaluate treatment efficacy, the intersection between disability and age discrimination, and enforcement.

Designation and responsibilities of a Section 1557 Coordinator (§ 92.7)
Policies and Procedures (§ 92.8)
Training (§ 92.9)

DREDF strongly supports the proposed rule’s requirement for covered entities to appoint a designated Section 1557 coordinator, establish clear civil rights policies and procedures, and train public-facing and other relevant employees on those procedures. These are all ways to elevate internal knowledge and proactive implementation of civil rights among covered entities and thereby alleviate the burden placed on individual patients when patient complaints are the primary means of triggering enforcement.

The “no visitation” policies adopted almost universally among in-patient facilities during the recent COVID-19 pandemic provides a timely and urgent reminder of why broader and deeper awareness of civil rights is needed among health care entities. Family members, friends, and paid caregivers who provide the personal care assistance needed by people with a range of disabilities were treated as simple “visitors” [1] and turned away by security personnel, nurses, and other health care providers. The result placed people with disabilities at grave risk of having their communication and health care needs ignored or misunderstood, left unable to equally benefit from health care services, or being forced to undergo additional invasive procedures such as restraint or the insertion of a feeding tube. The COVID-19 public health emergency only highlighted how hospitals and health care facilities of various sizes have long failed to fully integrate and operationalize civil rights laws, leaving people with disabilities, their advocates, and their family members with few or no timely options to obtain the effective communication and policy modifications necessary for good health outcomes.[2]

Violations of disability civil rights laws occur not only due to intentional ill will. They can happen because of ignorance, “benign neglect,” and administrative indifference, as noted by both the Supreme Court in its established interpretation of Section 504[3] and in the findings of the Americans with Disabilities Act of 1990 (ADA).[4] In the arena of health care, covered entities tend to prioritize the establishment of policies, procedures, and a “chain of command” for meeting medical regulations. By contrast, civil rights regulations are viewed as an inconvenient add-on obligation to the degree that they are known at all. A recent survey of over 700 physicians in US outpatient practices found that more than 71% did not understand how the process of a reasonable accommodation works and 20% made false assumptions about how such accommodations are paid for, but only 36% admitted they know little or nothing about their legal obligations under the ADA. [5] Fortunately, there is also a countervailing awareness across all segments of the health care system, from providers to insurers to public health, that technical adherence to medical regulations does not automatically achieve equitable health care and more needs to be done to eliminate embedded systemic and implicit bias.[6]

The proposed rule’s requirement to identify an internal employee who retains ultimate responsibility and authority to ensure that people with disabilities and other underserved individuals receive their rights, along with the requirement for establishing civil rights policies, procedures, and staff training, will go far toward achieving a true merging of medical and public health regulations with civil rights regulations. While smaller entities cannot be expected to have the same financial, human, and infrastructure resources as large systems, and that consideration is already built into consideration in this section, it is to their own benefit to have an internal source of information on these matters and to establish clear policies and procedures rather than rely on the discretion of individual public-facing employees, some of whom may be newly employed given high employment turnover rates.

Provider age and type of practice are also relevant factors to consider here. As of 2020, approximately one-third of physicians worked in practices with fewer than five physicians, and another 20% worked in practices with 5-10 physicians. Within this category of smaller practice size, there are identifiable trends. More than 60% of physicians aged 55 years and older worked in practices with 10 or fewer physicians, while only 41% of physicians under 40 years worked in similarly small practices.[7] This is an age group that likely had less exposure during their medical education and training to the equitable health care considerations that have evolved over the past couple of decades. Small physician practices are also more likely in smaller or rural communities where there is less provider choice within a reasonable distance. There are also large differences in the kind of specialties that are likely to be in solo practices. Over 25% of psychiatrists are in solo practice, followed by general internal medicine and family medicine.[8] Any exception in the proposed rule for smaller health care entities will therefore have an outsize effect on specific practice areas such as mental health and primary care which are already subject to physician shortages that are only projected to worsen over time.[9] It is more important, not less, for smaller practices in these areas to know and follow civil rights laws and remove access barriers for patients with disabilities.

We strongly recommend that smaller health care entities with less than 15 employees be subject to proposed §§ 92.7, 92.8 and 92.9 since they are still obligated to comply with Section 1557’s overarching nondiscrimination mandate and are prepared to do so when they have already prepared written policies for requesting reasonable modifications and resolving civil rights grievances. All sizes of entities should have full access to the technical assistance materials that HHS OCR will develop and the tools to promote civil rights adherence within their own practices.

Notice of nondiscrimination (§ 92.10)
Notice of availability of language assistance services and auxiliary aids and services (§ 92.11)

DREDF supports the proposed rule’s balanced restoration of notice requirements for Section 1557. Proposed § 92.10 requires covered entities to provide recurring annual notice of Section 1557 rights to people who currently participate in health care programs, people who apply to those programs, and members of the public. The notice must include all the protected bases of nondiscrimination recognized under Section 1557, including limited English proficiency, sexual orientation, and gender identity. It must also indicate that the covered entity will provide reasonable modifications, auxiliary aids and services and alternative formats to people with disabilities, free of charge and in a timely manner, when needed by people with disabilities to achieve accessibility and an equal opportunity in health care. The notice would also have to be given out upon request and must be clearly displayed on the entity’s website and in “clear and prominent physical locations where it is reasonable to expect individuals seeking service from the health program or activity to be able to read or hear the notice.”

A notice that clearly explains the breadth of Section 1557 rights, and provides information on how to practically obtain those rights, including contact information for the entity’s 1557 coordinator, is particularly important for people with disabilities because disabilities can be acquired at any point in life by individuals who may have little or no preexisting knowledge of disability rights. As stated in a post-COVID-19 focus group of older persons aging with disabilities and aging into disability when discussing the most iconic disability rights law, the Americans with Disabilities Act of 1990 (ADA), “there is still a vast majority of people who are unaware of ADA and disability rights.”[10]

Similarly, DREDF supports including the availability of auxiliary aids and services within the language notice required under proposed § 92.11. In general, research on health and health care outcomes when people with communication disabilities such as speech, language, voice, and/or hearing don’t receive effective communication is not as well-developed as research on the impact on LEP individuals when they do not receive health and health care information in the language they use. Nonetheless, the Joint Commission has long included people with communication disabilities[11] among patient groups that require additional support and effective communication to achieve equitable access to health care. The National Health Interview Survey did not even include a specific question about communication disabilities until 2012. When that data was analyzed in 2019,[12] the authors concluded that people with communication disabilities “represent 10% of the US population, have high rates of health care utilization, and experience significant disparities in health and health care outcomes.” Another study is currently recruiting subjects[13] to investigate the efficacy of two interventions for alleviating poor patient-provider communication that contribute to the health care inequities experienced by people with communication disabilities. The growing body of research, coupled with existing complaints and litigation, certainly warrants having language notices in significant communications that are consistently inclusive of people with disabilities and increases their ability to receive effective communication in health care, thereby reducing health care mistakes and their health and economic consequences. The key is to ensure that notices are sufficiently brought to the attention of people who have disabilities that can interfere with typical ways of reading and understanding the content of the notice. Covered entities need to have active obligations to notify members and beneficiaries of their right to request effective communication and auxiliary aids and services, including recording granular information about disability function and accommodation needs in electronic health records. People with disabilities over 18 years have significantly less access to cellular/broadband internet access than those without disabilities.[14] Household residents with disabilities 45 years and over have 9-10% less access than their similarly aged non-disabled peers.

While we support §§ 92.10 and 92.11, including a revised notice requirement that does not require a 1557 notification to be sent out with every patient/member contact and requires the notice of auxiliary services and supports in a specified list of significant communications, we make the following additional recommendations to ensure that the proposed notice requirement is as effective as intended:

• The § 92.10 and § 92.11 notices should be posted not only in locations where individuals seeking service will be able to see or hear it, but also be posted prominently where frontline employees can see it and be trained to use it to communicate the rights described to those individuals with communication or cognitive disabilities who face evident barriers to seeing, hearing, or understanding the notice without auxiliary aids or services or other means of assistance.
• Covered entities must ask members/beneficiaries whether they have communication disabilities and record their needed auxiliary aid or service in the electronic health record so that they can consistently receive effective communication from the covered entity.
• The § 92.11 Notice should be visually distinguishable on a printed page through the use of large sans serif print that is a minimum of size 18 font.
• The regulation itself should explicitly clarify that any request for all written communications to be rendered in alternative formats or in LEP languages necessarily include, but are not limited to, the finite list of significant communications in subsection 92.11(c)(5).
• The critical importance of clear communication in health care settings warrants the inclusion of a requirement that covered entities, in determining what is an appropriate auxiliary aid or service, should give primary consideration to the requests of the person with a disability.

Effective communication for individuals with disabilities (§ 92.202)
Accessibility of information and communication technology for individuals with disabilities (§ 92.204)

DREDF supports §§ 92.202 and 92.204 on effective communication and accessible information and communication technology (ICT) requirements for people with disabilities. We agree with the inclusion of a definition of ICT in § 92.4 given how important interoperable electronic health records will become if/when people with disabilities seek things like care coordination and integrated care among multiple providers. We also agree with the inclusion of mobile applications within § 92.204(b), which will hopefully help spur greater awareness among software developers of the need for mobile applications that are fully accessible to people with disabilities and compatible with mobile devices and internet platforms that are favored for accessibility reasons.

In response to OCR’s request for comments on whether the Section 1557 rule should require covered entities to comply with specific online accessibility standards, we recommend requiring covered entities to comply over time with the latest WCAG guidelines as they are updated by the Web Accessibility Initiative.  As noted in the preamble to the proposed rule, vital health and health care information is now commonly communicated via websites, including notices of civil rights and how to request language support and auxiliary aids and services. Covered entities must undertake periodic assessments of their websites to both maintain existing accessibility and keep up with evolving accessibility standards since there is little point to having a notice that is featured prominently on a website that is unused by people with disabilities due to absent or inconsistent real-life accessibility. A requirement to keep up with the latest standards could offer a range of time, so that larger entities with more resources will have a shorter period to comply with a newly published WCAG standard while smaller entities with fewer resources will have more time to do so.

Finally, we recommend that § 92.202(b) explicitly parallel the language in § 92.201(b) by stating that auxiliary aids and services must be provided free of charge, be accurate and timely, and protect the privacy and the independent decision-making of the individual with a disability. While those requirements and others are incorporated through § 92.202(a)’s reference to 28 CFR 35.160 through 35.164, smaller covered entities that are creating 1557 policies and procedures without necessarily obtaining legal advice may simply look to §§ 92.201 and 92.202, noting the seeming difference in language between the subsections. OCR’s provision of technical assistance that addresses specifically and in plain language what is required under 28 CFR 35.160 to 35.164, in conjunction with what is required under § 92.201 of the proposed rule, will also be helpful.

In our work, DREDF has seen the consequences when people with disabilities do not receive effective communication or needed auxiliary aids and services in health care. In the best scenario, people with disabilities experience lost time, inconvenience, and the expenses of travel, lost work, paying for personal care assistance, and so forth. In the worst case scenarios, people with disabilities experience lost opportunities to book appointments and get needed care, assault as health care is performed upon them without informed consent, incorrect diagnoses based on incomplete information, and injury or death. We support the provisions and only note that the provisions should incorporate stronger references to the needs of people with communication disabilities, particularly those who use Augmentative and Alternative Communication (AAC) devices, as well as those who require plain language.

Accessibility for buildings and facilities (§ 92.203)
Requirement to make reasonable modifications (§ 92.205)

DREDF supports § 92.203, which preserves prior existing requirements for structural accessibility in accordance with the 2010 ADA Standards for Accessible Design, as defined at 28 CFR 35.104 and incorporated in the definitions of the proposed rule.

and the provision of reasonable modifications. However, we object to the ongoing and inexplicable incorporation, in § 92.04(c) of the proposed rule, of the Uniform Federal Accessibility Standards (UFAS) for a subset of facilities or parts of facilities “in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State Exchange in conformance . . . if the construction was commenced on or before July 18, 2016, and such facility was not covered by the 1991 Standards or 2010 Standards.” The UFAS have long been outdated. They were outdated in 2016, when DREDF first objected to their incorporation within the first proposed set of Section 1557 regulations, for reasons that we provided in detail in DREDF comments that we submitted in November 2015.[15] Other federal agencies such as the Department of Veterans Affairs (VA), a founding agency behind the 1968 Architectural  Barriers Act which first established the UFAS, have come to recognize the outmoded and limited accessibility standards preserved in the UFAS. On its website, the VA states:

The Americans with Disabilities Act (ADA) of 1990 set accessibility requirements for state and local government, as well as private sector projects, similar to the requirements set for Federal projects through the Architectural Barriers Act. The ADA guidelines are called the ADAAG Standards. Today, VA follows GSA and other standard-setting agencies in replacing UFAS with the Architectural Barriers Act Accessibility Standard (ABAAS) for Federal Facilities. In addition, VA uses the Barrier Free Design Standard to meet the needs of the Department of Veterans Affairs in its health care facilities.[16]

DREDF recommends that the proposed rule omit the last sentence of § 92.04(c) and require any facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State Exchange to be required to come into compliance with the 2010 Standards. At most, the proposed rule could recognize a narrow set of circumstances in which facilities that were constructed or altered before July 18, 2016 and that were not subject to the 1991 or 2010 standards would have to meet the 1991 Standards rather than the 2010 Standards for a period of time up to a specific end date. But allowing covered entities of any kind to place health programs or activities within a building that has structurally obsolete accessibility requirements, in effect creating a permanent “safe harbor” for a very few buildings, is a grave disservice to people with disabilities who will have come to experience higher functional standards of physical accessibility in activities ranging from banking to grocery shopping to eating out.

We also highly recommend that the proposed rule, at § 92.101(b)(1) follow a tailored incorporation of Section 504’s structural accessibility regulations, one that does not include §§ 84.22 and 85.42 of the Section 504 regulations. Those 504 regulations incorporate a concept of “program accessibility” that was developed specifically for government programs and activities which were still often administered in historic older buildings, and contemplates a situation where new construction and alterations were not common or where at least part of a government program/activity occurred in locations protected by federal, state, or local laws that protected historic structures. When we look at health care in the US, we contemplate a highly devolved system in which multiple large entities accept federal financial assistance and/or contracts to deliver health care services and participate in federal and state marketplaces. Many of these corporate entities are continually engaged in new construction for their own headquarters, for hospitals and facilities that they own, and in contracts with large networks of providers, clinics and other health care facilities. There is absolutely no rationale for “program access” as a concept to be incorporated or applied to these corporate and private covered entities.[17]

DREDF agrees with § 92.205 which preserves an existing requirement for covered entities to provide reasonable modifications to people with disabilities when needed for equally effective health care. However, we strongly recommend incorporating existing standards relating to accessible medical and diagnostic equipment that were developed by the U.S. Access Board and finalized in 2017 within the proposed rule. For some people with disabilities, medical equipment accessibility is as necessary to equally effective health care as the accessibility of buildings and facilities and is equally linked to requests for reasonable modifications in a covered entity’s policies and procedures. This recommendation will be discussed further in a later section.

Nondiscrimination in health insurance coverage and other health-related coverage (§ 92.207)

DREDF strongly supports the proposed restoration of broad language prohibiting benefit design discrimination on the basis of disability or any other protected basis. People with disabilities have historically endured discrimination in health insurance,[18] ranging from outright denial of coverage to exorbitant premiums to exclusions, coverage caps, and “special” co-pays, higher co-insurance, and arbitrary exemptions that don’t count toward a deductible, all triggered by the mere fact of having a disability or chronic condition. Insurers were not required to share actuarial calculations justifying denials or imposing greater costs on people with disabilities, nor did they have to undertake any kind of individualized assessment of any applicant’s health. While the ACA prohibited some of the worst discriminatory insurance behavior, such as outright denial of coverage or dropping people with disabilities from coverage, it did impose new benefit design prohibitions on top of existing discriminatory practices that had already endured for decades. We have an existing discriminatory insurance system being slowly dragged into the light, not a requirement to issue new insurance policies that have been scrubbed of discriminatory language, practice, and reimbursement policies.

For example, private insurers place unique annual coverage caps on items such as wheelchairs, commonly fail to provide any coverage for items such as hearing aids for adults, place stringent utilization management controls on medications or preventive treatments that are primarily used by people with specific chronic conditions or who are at greater risk of acquiring conditions such as AIDS/HIV, and fail to make or publicize any modifications for people with disabilities who can experience unusually serious side effects because of interactions with other medications they must take. People with disabilities bear the brunt of these kinds of benefit design decisions or omissions, and they also bear the burden of factually establishing discrimination when data either doesn’t exist at all or the issuer holds the data on details of coverage, denial rates, reasons for denial, and the presence or total absence of “a legitimate, nondiscriminatory reason for determining that such health service fails to meet applicable coverage requirements in any given individual case,” as detailed in § 92.07(c). For § 92.07(c), we recommend additional clarification from OCR and HHS emphasizing that insurers must provide a plain language explanation of how general nondiscriminatory coverage requirements such as medical necessity or clinical standards apply in an individual case. DREDF has seen coverage denials up to the plan appeal level that circuitously justify discriminatory benefit design by reiterating that the plan’s general benefit does not cover the prescribed treatment, service or device, without any indication of whether and how relevant clinical standards were considered in the benefit design exclusion, or why the specific patient’s medical need is considered irrelevant to an assessment of that patient’s coverage.

We also caution against benefit design exclusions that are neutral on paper, but that exclude or place unique limitations on benefits that are closely aligned with identifiable groups of protected classes. Such pairings may include, for example, adult hearing aids and Hard-of-Hearing persons, wheelchairs and people with mobility/strength/balance disabilities, therapies or treatment regimens that are primarily associated with specific disabilities such as Autism, or rehabilitation/habilitation therapy for adults with degenerative muscular conditions as they age. Where a covered entity contracts with a 3^rd party such as a Pharmacy Benefits Manager (PBM) that imposes utilization management techniques on specific treatments, the regulation should continue to hold covered entities as well as 3^rd parties accountable for imposing discriminatory benefit design limitations; this will encourage covered entities to require transparency from their sub-contractors. And finally, we note that for individuals who have rare or “orphan” conditions, and may therefore lack the kind of “clinical, evidence-based criteria or guidelines” that should ideally form the basis for a covered entity’s benefit design decisions. DREDF asks OCR to clarify that it will impose additional scrutiny on covered entities when they justify benefit limitations without clinical, evidence-based criteria. OCR will not necessarily scrutinize a covered entity’s guideline where recommends honoring a treating provider’s authority to prescribe a therapeutic treatment, service, or device in cases that lack established clinical guidelines.

We also want to applaud the addition of § 92.207(b)(6). The explicit requirement that health insurance coverage and health-related coverage must include the provision or administration of that coverage in the most integrated setting appropriate to the needs of covered individuals with disabilities acknowledges a fundamental tenet of disability rights law and the pivotal 1999 Supreme Court decision in Olmstead v. L.C. by Zimring.[19] By explicitly incorporating this requirement into Section 1557, people with disabilities and disability advocates can use it to point out an increased risk of isolation, unmet health care needs, and lost functional capacity they experience when state Medicaid agencies, Medicare plans or private insurance policies place arbitrary distinctions on when and where services or treatments can be provided. For example, coverage of treatments needed by people with a range of chronic conditions such as podiatric care or diabetes management or physical therapy, or even home vaccinations needed by people with significant mobility disabilities during a pandemic, cannot be made available only to members/beneficiaries who are in institutional care if those who reside in the community have the same medical need for the treatment.[20] The fact that it might be more convenient or appear less expensive to administer a specific service to institutional residents who are gathered in one location is not a factor that is relevant to clinical or medical standards of care which are evaluated at an individual level.

The new provision’s emphasis on benefit design notifies private issuers that they need to review their health insurance and health-related products for arbitrary and inappropriate design features that are contrary to the integration needs and goals of disabled persons. It is one thing if a particular insurance benefit can only be provided in an institutional setting for clinical or medical reasons, and another thing for an insurer to limit the benefit’s provision to an institutional setting for provider convenience, because “that is how it has always been done,” or because the benefit is inherently designed in a way that funnels individuals to institutional care. In the area of mental health consumer and whistle-blower reports have long noted how private insurers fail to provide the range of intensive, wrap-around services that people with significant long-term mental health disabilities may need.[21] Private insurers may be starting to pay attention to this problem, but they must also pay attention to mental health benefit design options that emphasize community-based early intervention and long-term strategies that give insured consumers the chance to remain in their communities while receiving clinically appropriate health care. An explicit integration mandate for benefit design also necessarily requires insurers at the design stage to consider the kinds of barriers that consumers in the community commonly face, and especially persons with disabilities who may need accommodations around transportation, effective communication (especially in conjunction with Limited-English Proficiency), appointment times, and so forth to be able to realistically participate in a benefit. This provision and any additional concrete guidance that will help insurers to appreciate that a covered benefit cannot be so narrowly defined that it inherently favors categories or types of health care that are segregated such as residential mental health care or long-term care settings.[22]

The new provision also provides a standard against which unreasonable coverage restrictions found in Medicare Advantage and Exchange plans can be assessed. For example, an “use-in-the-home” policy that is applied to determine when an insurer will cover the provision of medically necessary wheelchairs for Medicare beneficiaries potentially runs afoul of this provision if the policy is used to deny a wheelchair that an individual needs to access the broader community outside their home.  Any policy that only considers covering an individual’s wheelchair and ancillary equipment and services if the wheelchair is strictly needed for activities of daily living (e.g., toileting, grooming, eating) within the house, irrespective of the individual’s need for a wheelchair to travel any distance outside of the home or undertake desired activities within the community such as shopping, getting to work, attending worship services, or sharing a meal with a friend, is potentially discriminatory because it is an administration of health insurance benefits that denies the most integrated setting appropriate to the individual. A home in the community may be less restrictive than an institutional placement but making medical benefits conditional on their exclusive use within one’s home effectively serves to imprison a beneficiary within that home when beneficiaries fail to receive coverage of medically needed services, treatments, and items that enable them to function independently and safely in the community at large. The positive obligation to use benefit designs that provide coverage “in the most integrated setting appropriate to the needs” is particularly needed as states increasingly turn to managed care plans to administer Medicaid.[23] Large plans that administer a range of employer, private small group and individual plans, as well as public Medicare and Medicaid plans, could easily default to unified coverage policies for things like wheelchairs and other durable medical equipment that have a “use-in-the-home” condition, even though it contradicts a stated commitment to community integration and rebalancing.

Use of clinical algorithms in decision-making (§ 92.210)

States, health plans, and health care providers increasingly are using algorithms and devices driven by artificial intelligence (AI) to support clinical decision making and establish clinical care standards. These tools are also widely used to support and inform population health management. Even as this evolving technology holds great promise for improving health care and health outcomes, it also can contribute to discrimination and amplify certain structural barriers and inequities that affect marginalized groups, including people with disabilities. Important work has been done that identifies how disability bias in algorithms negatively affects, for instance, employment decisions,[24] determination of the need for Medicaid personal care services in the home,[25] and the ability of autonomous vehicles to recognize pedestrian wheelchair users.[26] Race and ethnicity bias in certain algorithmic tools and AI also has been well documented.[27] Yet, very little work has been done to understand how bias in algorithms and AI affects people with disability in health care even as it has the potential to profoundly affect health care decisions, services, and outcomes for this large population. Moreover, when disability intersects with other marginalized identities, algorithmic and AI bias can further stigmatize patients, misdirect resources, and reinforce or ignore barriers to care rather than serving as a pathway to improving treatment and health outcomes.

As a national disability rights organization, DREDF lacks the technical capacity on our own to discern when a covered entity is using AI or recognize the presence of algorithmic bias in health care decision-making. Covered entities must be required to disclose their use of algorithms and they must do so before they are placed into operation. This is especially true when the application of predictive data are literally a life and death matter, as in the case of Crisis Standards of Care which only rose to public attention and discussion during the COVID-19 pandemic, as surge conditions in health care utilization prompted hospitals and health systems to review and prepare such standards for use. People with disabilities and their families were caught with no input and little recourse as states adopted standards for COVID-19 hospital care that explicitly and implicitly devalued the lives of people with disabilities, chronic conditions, and specific health conditions,[28] and called for deprioritizing people with disabilities for life-saving care, ventilator use, and even a bed in the hospital. Older persons were similarly devalued, as were people of color given higher incidences of chronic health conditions among Black persons, Hispanic persons, and American-Indian/Alaskan Native populations who have endured long-held barriers to equal health care and social drivers of health. Many crisis standards of care relied substantially on both stereotyped assumptions about the value of people with significant disabilities and medical algorithms for estimating a patient’s survivability. These algorithms assessed an individual’s potential response to life saving care without making an individualized assessment of the particular patient’s health and without providing any modification for how an individual’s disability could affect the assessment factors used in the algorithm or the time needed for the individual to respond to treatment. In short, many crisis standards of care were discriminatory,[29] and many may continue to be so, given that they are once again out of the public eye.

Disability discrimination that was commonly present in Crisis Standards of Care used during the pandemic show how ableism is accepted and omnipresent in health care decision-making, but as this new provision specifically evokes algorithms, DREDF proposes the use of a short working definition of algorithms at least for discussion purposes. Algorithms used for decision-making in the health care context can be distinguished from other tools that may employ some element of artificial intelligence as a way of sorting and evaluating large amounts of potentially predictive data, for example, to create scoring guidelines. DREDF considers algorithms to be “those sets of instructions fed to a computer to solve particular problems.”[30] We also agree with a definition of algorithmic bias as “…the application of an algorithm that compounds existing inequities in socioeconomic status, race, ethnic background, religion, gender, disability, or sexual orientation and amplifies inequities in health systems,”[31] but neither we nor individual patients with disabilities can bear the burden of understanding how AI and complex algorithms work and demonstrating the presence of bias. Even if a few of us might have the expertise, many algorithmic tools are proprietary and cannot easily be fully interrogated for potential biases. We therefore appreciate and support an approach that “does not hold covered entities liable for clinical algorithms that they did not develop but holds entities liable under this proposed section for the decisions they make in reliance on such algorithms.”

While DREDF is concerned with how algorithms are created and how developers evaluate the fairness of the formula and data inputs used, the crux of our concern with computer-mediated tools is that the human decision-makers who bear ethical and professional obligations as health care providers and entities have changed their decision-making process. Furthermore, they may choose to do so without any notice of the change. In essence, they may believe they have fully delegated their decision-making authority and should no longer be held accountable for the discriminatory outcomes because computers cannot “intend” discrimination. This provision clearly refutes both the false assumption that discrimination depends upon animus or an intention to discriminate behind an algorithm’s use, and also holds covered entity’s responsibility for their use. This clarity is important. Once algorithms are involved and assigned a role within decision-making, there is a human tendency to give primary weight to the algorithmic output, decision, or recommendation, even in the face of conflict with human expertise, knowledge, and judgement. Examples of this deference to algorithms can be found in decisions made by pilots who defer to automatic flight control systems, as well as by physicians making treatment decisions in critical care units; the higher the stakes and, some might say, the greater the need for a human grappling with ethics, life values, and implicit bias, the greater the pressure to abdicate responsibility to an “objective” algorithm.

The approach used in § 92.210 also necessarily incorporates the potential for a covered entity to be liable for decisions based on biased algorithms as long as the outcome of those decisions is biased or discriminatory. The covered entity’s own intention to discriminate, whether it knew about a specific risk of bias beforehand, or simply did not bother to check the possibility of bias or ask questions of the developer, is irrelevant to whether the covered entity uses algorithmic tools that violate this standard; that fact should be explicitly expressed within the new provision. Covered entities are driving market demand for the use of algorithms and AI in health care, are paying for the development of tools, and have resources to check for algorithmic bias. Unless a covered entity can establish that a developer misrepresented its tool or made reasonable false assertions about the lack of algorithmic or AI bias in a tool’s failure to ensure that people with disabilities receive meaningful benefit from the tool’s use. Given the rate at which advances in AI are being made, we recommend that this section address the use of algorithmic tools and AI broadly so potential new developments that are quickly adopted across the health care industry will be undoubtedly regulated without need for future changes to the regulation.

We further recommend that the following principles be succinctly expressed within the provision so that covered entities clearly understand their responsibility for understanding and checking the algorithmic and AI tools they choose to use. The goal is to increase equity and fairness and avoid discrimination and inappropriate care decisions for people with disabilities, including those of all races and ethnicities, all ages, and those who have diverse sexual orientations, gender identities or gender expressions.

• Covered entities must be transparent about the areas in which they adopt algorithmic and AI use, the populations they are used with, what the tools determine, when the tools are used, and any instances in which the tools outcomes are mitigated or altered through human intervention.
• Covered entities that choose to use algorithmic and AI tools must bear a proactive burden to document the steps they took to choose unbiased and open source algorithmic or AI tools and establish how the algorithmic/AI tools they use are free of bias toward any protected ground, the algorithm’s impact on clinical decision-making, and the steps undertaken to avoid bias and unfair outcomes to consumers on protected bases.
• Adoption of algorithmic and AI tools must go hand in hand with a covered entity’s ongoing commitment to improving its databases and collecting granular disability demographic information from members/beneficiaries who voluntarily provide the information; without improved disability data it will be impossible to identify if and how the use of algorithmic and AI tools is changing the health care inequalities experienced by people/members with disabilities.
• The covered entity must establish standards for ongoing external oversight and evaluation of AI use as long as algorithmic and AI tools are used.
• Covered entities must developing disability-inclusive ethics and an ethics review process that recognizes the equal worth of people with disabilities and their right to treatment without bias, the full benefits of their health insurance coverage, nondiscrimination, and effective communication and policy modifications of people with disabilities, including when clinical algorithms like the Sequential Organ Failure Assessment (SOFA) is used. People with disabilities must be equal stakeholders in the ethics process.
• All patients, members, and beneficiaries of covered entities must include clear notice in any benefits denial notice of the fact that algorithms or AI was involved, and they must have access to an accessible, readily available appeal process that will include review of the use of the algorithmic or AI tool involved.

Nondiscrimination in the delivery of health programs and activities through telehealth services (§ 92.211)

The increased use of telehealth during and since the COVID-19 pandemic is another technology-driven change in health care delivery that has benefitted some people with disabilities while simultaneously creating new barriers for others. This is unsurprising given how heterogenous disabled people are. Disabilities and health conditions, even the same diagnosis, can have wide variance in their particular functional impact on disabled individuals, who themselves vary widely in their physical, educational, cultural, and socio-economic backgrounds. Someone who has aged into hearing loss and someone who is culturally Deaf and fluent in American Sign Language have different communication needs. Both might encounter barriers to using telehealth but for different reasons: an older person might need assistance with video call technology in her home and prefer to call in using her own amplified phone during the video call so she can speak with a provider while the Deaf person needs the provider’s proprietary video call technology to seamlessly integrate a pinned ASL interpreter with the video screen so they can simultaneously follow a provider’s facial expressions and demonstrations while seeing what the provider is saying. As another example, someone who has a speech disability may not require captions at all and is unlikely to use sign language, but while the system may have the capacity to allow the provider to receive typed communications from the patient with a communication disability, it might not have the capacity to receive other types of augmentative and alternative communication (AAC) used by the individual. In addition, the provider may not have allotted the additional time that the patient may need to provide information and ask questions through typing or another AAC medium.

DREDF supports this new provision that is specific to telehealth given the ubiquity of telehealth as a unique mode of health care delivery that has expanded greatly during the pandemic and which is likely to continue being widely used even without a public health emergency in place. It is a mode of delivery that offers patients with and without disabilities several advantages: an appointment usually can be obtained sooner, health care can be obtained in the privacy of one’s home without exposure to viruses or having to interact with strangers, transportation costs can be avoided, and it may be possible to forego losing wages for lost hours or having to make childcare arrangements. But these advantages are lost if telehealth fails to conceptually and practically accommodate those whose bodies or minds work in different ways, who need to see language rather than speak it, who need to touch or hear information rather than read it, or who do not have fine motor control for controlling common video technology or medical monitoring devices. While information and communication technology (ICT) are an integral part of effective health care, health care programs and activities consist of more than just information and communication. Proposed § 92.211 recognizes that telehealth is not just an alternate form of communication, but a distinct health care activity that needs to accessible to individuals no matter how a person’s body functions, the language used, and the person’s cultural or socio-economic context.

ICT in the proposed rule is primarily about information and communication that occurs as part of or ancillary to what we consider a primary health care activity such as a routine medical exam, mental health therapy, or a specific consultation on a presenting condition. Accessible ICT allows the flow of information and communication from a covered entity to be received by a patient with disabilities and patient responses to be made. An office visit is a complete means of health care service delivery: it should involve a constant exchange of information with provider and patient working together to figure out symptoms and a diagnosis, work through therapeutic interventions, and engage in a mix of reported and independent observation. A telehealth visit does not automatically equal an office visit just because the same parties face each other over a screen. For example, a study from 2020[32] found that blood pressure recording and cholesterol screening occurred significantly less often in a telehealth visit than during an in-person visit. The impact of differences in health and wellness screening are likely to be felt most keenly by individuals with chronic conditions such as diabetes and Chronic Obstructive Pulmonary Disease which occur at higher rates among people of color[33] and people with disabilities.[34] Telehealth can incorporate patient reporting of health statistics using mobile applications or “at-home tools” that enable a person to find their own blood pressure, pulse rate, blood sugar level, oxygen saturation rate, and even basic weight. But if the home replacement tools for the kind of monitoring that routinely happens at a doctor’s office are not accessible to individuals who are blind or who have fine motor disabilities, for example, then the entire telehealth visit is less reliable and useful. An in-person visit can also efficiently mix complementary preventive services, such as administering vaccines during a well-child exam, or making lab referrals and booking laboratory appointments or additional vision tests immediately after an office exam. A telehealth visit that attempts to take the place of what can be done in person can involve a higher degree of patient involvement, activity, and initiative such as using at-home glucose monitors and taking bodily fluid samples and sending them safely and securely to a lab.

The job of figuring out how these activities can be accomplished logistically, efficiently, and accessibly through telehealth cannot be placed on individual disabled patients. Covered entities must be responsible for ensuring that telehealth visits, which can often include real time interaction, pre-preparation monitoring and follow-up activity, provide equally effective care to all individuals regardless of “race, color, national origin, sex, age, or disability.” That goal cannot be accomplished by only offering accessible ICT during the visit. In DREDF’s work during and after the pandemic, we represented people with disabilities who were members of large health care systems that use their own proprietary telehealth technology. These members, who were Deaf, informed the provider of their disability before the telehealth appointment and requested an accommodation but still faced a lack of effective communication because the provider’s video system lacked the capacity to provide simultaneous embedded captions within the same video screen that is being used for the visit. Other Deaf members were told that, if they needed a sign language interpreter, then they had to come for an in-person appointment since sign language was not available using telehealth. Consent or other materials that would typically be sent to a patient before a telehealth appointment were not necessarily available in an accessible format for blind persons. Little or no thought was given to how people with disabilities could request and obtain accessible home tests or monitoring devices that would enable them to report health readings such as blood pressure or pulse rate to their providers before or during a telehealth appointment, or obtain and send fluid or other samples to a laboratory, or get follow-up information and care after a telehealth appointment. In other words, the expanding universe of telehealth is closed off to people with disabilities when their needs are not considered from the beginning. Even though, in time, as covered entities make telehealth fully accessible, the benefits will accrue to people with disabilities as well as those without disabilities. Individuals who share their living space and lack a quiet or private space for spoken information exchange during a telehealth visit, or who don’t have access to reliable internet service, could use in-screen chat and captioning to achieve greater privacy for health consultations in public or shared spaces. For additional considerations and inclusive requirements, DREDF endorses the Telehealth Principles developed by the Consortium of Constituents with Disabilities in July 2020.[35]

DREDF appreciates Section VII in the proposed rule and its invitation to comment on the importance of adopting the Access Board’s 2017 Medical Diagnostic Equipment Accessibility Standards[36] into enforceable regulation. We now have had almost six years to see what individual health providers and facilities, health care systems, hospitals, health insurers, and federal and state health care agencies would voluntarily do with the detailed, thorough consensus standards developed by the Access Board, and the answer is “very little.” The U.S. Department of Veterans’ Affairs adopted the standards[37] soon after their completion and applies them to the agency’s new equipment acquisitions but this example was not followed by others. In those five years, people with mobility, developmental, and strength and balance disabilities across a range of ages, different races/ethnicity, and LGBTQ+ status have continued to be denied access to the most basic medical procedures: a physical exam and an accurate measure of weight. As noted by the National Council on Disability in its 2021 letter on Enforceable Accessible Medical Equipment Standards – A Necessary Means to Address the Health Care Needs of People with Mobility Disabilities:

Without a regulation, widespread unavailability of height adjustable examination tables, accessible mammography equipment, accessible weight scales and lift equipment to facilitate transfers, among other accessible medical and diagnostic equipment, will remain the status quo. People with mobility disabilities will remain less likely to receive preventive health care services—like cervical cancer screening; colorectal cancer screening; obesity screening; and breast cancer screening.[38]

California provides a unique picture of equipment inaccessibility due to its requirement for the state’s Medicaid managed care providers to undertake a 3^rd party-administered site review process that includes questions on accessible scales and height-adjustable exam tables. In the decade between 2006 and 2016, a study[39] of information on thousands of primary care providers showed that 3.6% of offices with an accessible scale increased to 10.9% of offices with such a scale, while 8.4% of offices with a height-adjustable exam table improved to 19.1%. That leaves almost 90% of offices lacking an accessible scale, and over 80% of offices lacking an accessible exam table. Another innovative study that looked closely at how accessible equipment was distributed within Los Angeles County showed that within any given zip code there mostly was a single site, and not necessarily the same site, with accessible equipment or an accessible toilet room.[40] This means that people with disabilities have to choose among the sole provider where they could use the bathroom, the provider who can give them a full exam, the provider who speaks their language, or who is most likely to give them culturally competent care, or the provider they can reach in a reasonable amount of time. Note that this choice does not even raise the matter of which provider might have the most medical expertise or professional experience on any given health concern.

Inaccessible equipment is not a matter of mere inconvenience. Even if a disabled person has a family member or friend who might be able to accompany them to an appointment and provide transfer assistance, the consequences of doing so are borne unequally by low-income individuals and families of color who are least able to afford time off. An aging partner should not be expected to provide transfer assistance but is likely to feel pressured to do so. Patients with disabilities who are unfamiliar with disability rights or already uncomfortable with English are less likely to press for a full exam or insist on getting accurate current weight before medication strengths are prescribed or surgery with full anesthesia is scheduled. And those people with disabilities who have already had bad encounters with providers who lack accessible equipment and fail to take responsibility for that fact or the need for transfer assistance will simply avoid making health care appointments if they can’t bring assistants with them, whether they know their rights or not.

The ability to receive effective health care in one’s own community, with one’s freely chosen provider, in a manner that is as timely and appropriate as the care received by persons without disabilities, should not depend on whether one uses a wheelchair or has certain chronic conditions or is aging, but without enforceable medical diagnostic equipment standards this is the reality for thousands of people with disabilities. This is inherently discrimination based on disability and is why an enforceable requirement for accessible medical diagnostic equipment, along with scoping rules that establish how much equipment is needed by different sizes and types of facilities and a clear timeline, should be incorporated within the proposed rule. The request for comment asks whether accessible equipment is a matter of network adequacy or benefit design? It should be a matter for both. Network adequacy is a particular concern for managed care entities and health insurers who would have to monitor the availability of provider types with accessible equipment to ensure that an adequate range of primary care and specialist providers with accessible equipment were available so that any given network was not a matter of paper only for disabled members. Network adequacy will allow equipment accessibility to be considered in conjunction with other important components of adequacy such as time and distance standards or providers per member. Benefit design requirements embed accessible equipment considerations and require health insurers to proactively consider accessibility as an integral component of what constitutes a health care benefit. Network adequacy has existing state enforcement mechanisms that can be used by people with disabilities and disability advocates to ensure not only that equipment is available, but that policies and procedures are in place to ensure that disabled persons receive coordination around making appointments and having those appointments in rooms with working accessible equipment. Ultimately, both network adequacy and benefit design should incorporate medical diagnostic equipment accessibility requirements as important steps to involve all health care stakeholders in resolving this intractable problem.

(https://www.federalregister.gov/d/2022-16217/p-595 et seq.)

People with disabilities are among the population groups that experience significant health disparities.[41] They engage in preventive care at lower rates than recommended and report unmet health care needs. They delay or go without recommended care for a variety of reasons including disability related access barriers, such as provider inaccessibility, lack of accessible medical diagnostic equipment, and lack of necessary accommodations in health care settings. Health and health care disparities are compounded when disability intersects with race, ethnicity, gender identity, and age. The prevalence of disability increases with age and is especially high where age intersects with multiple marginalized identities, reflecting other systemic and historic barriers to health care experienced by these groups.

Disability, like race, ethnicity, and gender identity, is a bona fide demographic category. Therefore, health plans and providers should be collecting disability status information, voluntarily provided by patients, as a core demographic data element. This collection of data will serve at least three critical goals which are not necessarily listed here in order of priority. First, for the purposes of Section 1557 and clearly identified in the preamble to the proposed rule, disaggregated service delivery and complaint data is vital to ensuring civil rights compliance. Second, collecting disability status using granular functional limitation questions will allow for better measurements of health equity, the relationship between disability and social determinants of health, and more comprehensively support efforts to achieve health equity for this demographic group. And third, functional limitation information in Electronic Health Records (EHRs) will help providers to identify patients’ need for accommodations during clinical visits and hospitalizations, hopefully increasing the likelihood that accommodations needed for equally effective health care will be provided in a timely and consistent way.

For disability data, the “how” of obtaining data is inextricably intertwined with the “why.” For over a decade, advocates and researchers have called for adding functional limitation measures to patient EHRs. While providers typically rely primarily on symptoms and diagnoses to inform their perception of patients’ clinical profiles and need for care, these factors are an inexact proxy for functional limitations, which can vary widely within the same diagnostic category or health condition. Accommodation needs rarely can be inferred solely from diagnosis. Frontline provider staff cannot be expected to process effectively detailed clinical information, across a wide variety of patient disabilities and chronic health conditions, to ensure that individuals are accommodated and receive effective care. Therefore, covered entities involved in health care delivery should invite patients, at registration and when scheduling appointments, to self-identify any functional limitations and their answers should be recorded in the EHR. Those who self-identify functional limitations should also be provided an opportunity to specify any needed accommodations and that information should also be added to the EHR. This information, when accompanied by an internal system of alerts, ways to update information, and sufficient staff training will go far toward achieving equitable health care for people with various disabilities.[42] In addition to civil rights monitoring, research, and identifying accommodation needs, this data is required for other key purposes such as disaster planning and planning responses to public health crises as evidenced by the COVID-19 pandemic.[43] Lack of accurate and sufficiently granular functional limitation data for people with disability masks the urgent need for policies and procedures that improve access to care and health outcomes and undermines the delivery of effective, equitable, patient care.

Models exist for collecting functional limitation data along with other demographic patient data that could be a starting point. For instance, the six-item set of disability questions used by the American Community Survey (ACS)[44] and other major federal surveys is currently the minimum standard for collecting data on disability. This question set has been tested and validated and has the additional benefit of facilitating interoperability with census data. The Washington state legislature passed new rules that require hospitals, effective in 2023, to include patients’ race, ethnicity, sexual orientation, gender identity, primary language and disability status in all discharge reports.[45] Oregon state implemented new rules in 2020 that require health care providers to collect and report race, ethnicity, language and disability data related to COVID-19 to the Oregon Health Authority.[46] And in July 2022, the Office for the National Coordinator for Health Information Technology (ONC) took the first steps towards setting a national standard for documentation of patients’ disability status in the EHR by including disability status elements in the United States Core Data for Interoperability (USCDI) Version 3 standards.[47] The disability data element was included after advocates presented detailed recommendations that were included in the Interoperability Standards Workgroup Report.[48] These recommendations incorporate the set of six questions from the ACS and adds a seventh communication disability question because 10% of the US adult population has a disability related to speech and/or hearing disability and the most frequent disability rights complaint in health care is the lack of effective communication for patients with communication-related disabilities.

DREDF supports the Department’s intended use of existing civil rights authority to develop a system for requesting compliance data from covered entities, but we equally call upon the Department to establish a specific provision within the proposed rule that will require covered entities that use EHRs to systematically collect and maintain demographic information on granular disability functional status within the EHR. Including such a provision as soon as possible will allow patients to learn about and become comfortable with the role of data in holding covered entities accountable for civil rights compliance and therefore encourage the voluntary filling in of disability status. The more people with disabilities provide information on their granular functional status, the sooner we will gain sufficient sizes of population groups, and particularly intersectional sub-population groups such as black women with mobility disabilities or older gay men with hearing disabilities, to allow for reliable data analyses. And finally, granular functional status information in EHRs will pave the way for critical accommodation information that can concretely improve quality and equity in the health care delivered to people with disabilities.

In our work at DREDF, we have represented individuals with a range of disabilities who, in their ongoing interactions with health care systems and providers, would benefit greatly from having their self-identified and voluntarily provided functional limitations and accommodation needs included in their electronic health record. If health facility employees were properly trained in recording and using this information, it would save people with disabilities the great frustration of having to repeatedly request Braille materials, sign language interpreters, and accessible exam rooms and tables; making requests that can still be overlooked on the day of an appointment because the appointment scheduler may not have made an appropriate notation in the appointment book, failed to schedule for an interpreter, or was not working on the patient’s appointment day. One very recently published study made groundbreaking findings on how the failure to use self-reported information on disability likely leads to underreporting of the numbers of people with specific disabilities as well as underestimates of the degree of health and health disparities experienced by people with disabilities. The study focused on perinatal care for women with disabilities, but unusually chose to use information on self-reported disabilities obtained through the National Survey of Family Growh rather than estimate disability through the diagnostic codes that are currently available in the EHR. The authors found:

We compared respondents with and without disabilities on these characteristics: smoking during pregnancy, delayed prenatal care, preterm birth, and low birthweight. A total of 19.5 percent of respondents who had given birth reported a disability, which is a much higher prevalence than estimates reported in US studies using diagnosis codes. Respondents with disabilities were twice as likely as those without disabilities to have smoked during pregnancy (19.0 percent versus 8.9 percent). They also had 24 percent and 29 percent higher risk for preterm birth and low birthweight, respectively. Our findings suggest that studies using diagnosis codes may represent only a small proportion of pregnancies among people with disabilities. [49]

A. Restoring the Scope of Section 1557 and Capturing Part B Providers and Health Research Activities

We strongly support the proposed rule’s restoration of Section 1557’s intended statutory scope, from federally conducted or federally funded health care programs such as Medicare and Medicaid, to Marketplace issuers and plans, to private health plans and insurers if any part of them receives federal financial assistance. The ACA’s broad purpose was to expand access to affordable quality health care for as many people as possible. To do so effectively, its provisions had to reach all of the US’s complex network of private and public health care entities. Section 1557, the primary nondiscrimination provision embedded in the act, logically extends to all the same entities as those covered in the ACA as discrimination interferes with access to affordable quality health care.

In response to HHS’s request for comment,[50] DREDF supports extending Section 1557 to HHS’s non-health programs and activities. The department’s multiple Agencies and Offices support social and economic well-being in children, families, and older adults, emergency and disaster preparation, public health, health and policy research, regulation of food and medical devices, disease control, and many aspects of administrative and legislative coordination.[51] Some of these bodies are not directly involved in health care delivery or funding health insurers, but their work together sets the framework and priorities for federally funded and conducted health care efforts. The application of civil rights principles and nondiscrimination protections     across the breadth of HHS will help ensure that implicit bias, racism, ableism, ageism, and discrimination on the basis of sex are recognized at these early stages of planning and not only at implementation. For example, the Center for Disease Control (CDC) played a central role in the recent COVID-19 pandemic, authorizing vaccine use and providing public information about infection control. At the same time, the CDC seemed to have minimal awareness about people with functional disabilities living in the community and the actual risk levels they experienced, leading to extended isolation and heightened risks for disabled persons and older adults. Similarly, HHS Agencies and Offices that engage in public health investigation into the social drivers of health and health disparities are making connections that must include people with disabilities and all the groups protected under Section 1557, including ensuring language assistance services when stakeholder feedback and public comment is sought. A separate rulemaking that extends nondiscrimination protections to the “non-health” HHS programs and activities that plan, coordinate new initiatives, set inter-agency priorities, and grant funding work will lead to much needed consideration throughout the Department on how to involve protected groups under Section 1557 and achieve greater equity in all of HHS’s work.

We note and strongly support HHS’s decision to interpret Medicare Part B payments as federal financial assistance (FFA),[52] thereby including Part B providers as recipients of FFA under Section 1557, Title VI, Title IX, Section 504, and the Age Act.

Comments submitted by Disability Rights Education and Defense Fund (DREDF) to HHS in November 2015 on its first Notice of Proposed Rulemaking for Section 1557 provided a detailed explanation at pp. 2-7 on how the original rationales used to exclude Part B providers from prior civil rights laws were based upon wording in those laws but not in Section 1557 that excluded “contracts of insurance,” as well as an outdated assumption that the Medicare program did not directly pay Part B providers.[53] The proposed rule’s inclusion of Part B providers as covered entities will have little or no impact on the great majority of Part B providers who are already subject to Section 1557 through receiving other forms of federal financial assistance. However, the change will be a significant relief to disabled and older patients who will no longer have to parse out whether they have Medicare or Medicaid, be prepared to trace the various kinds of insurance funds their provider takes, or be anxious about health insurance transitions when they turn 65 years old before filing a complaint under Section 1557 on their experience of discrimination.

Finally, we also strongly support the proposed rule’s explicit incorporation of “any project, enterprise, venture, or undertaking to engage in health research” in the proposed rule’s definition of “health program or activity” in § 92.4. HHS provides multiple grants, funding, and guidance for health and health care research that will lead to evidence-based treatment and clinical standards. The explicit or implicit exclusion of people with various disabilities from clinical research will lead to treatment standards that will ignore the needs of people with disabilities. Whether federally conducted or federally funded health programs or activities, all government supported research activity must incentivize and procedurally ensure the inclusion of disability-related issues, research into disability health and health care disparities, and a full range of diverse participation in clinical trials from both those conducting research and those voluntarily participating as subjects. Commentators acknowledge that health care research “must strive to represent all populations that will eventually use the tested drugs and devices,” but the call for diversity provides examples “such as race or ethnicity, ancestry, language, religious practices and sexual orientation” that conspicuously exclude disability, chronic conditions, or functional capacity.[54] Yet who are the intended populations who will be the likely end users of new drugs and devices if not disabled persons who have the condition that is being researched? Institutions such as the National Institute on Minority Health and Health Disparities acknowledge the same historic lack of diversity and inclusion in minority trials and provide a much needed call for the greater inclusion of women, racial and ethnic groups, and sexual and gender minority populations, which latter group also experiences an underlying insufficiency of sexual and gender identity data collection that would allow for analysis of the extent of their exclusion and the research disparities they experience.[55] The Institute makes no similar analysis or call for participation of people with disabilities, even though they experience data insufficiency that is highly akin to what sexual and gender identity populations face. Only very recently have we begun to see a case being made for disability inclusion as a necessary component in research study diversity.[56] Given the long history of disabled people’s exclusion from clinical and health research, we recommend that HHS OCR provide technical guidance in what inclusion in clinical research looks like and how it can be achieved through nondiscriminatory research protocols.

B. Disability and Sex Discrimination in Abortion and Medication Access (§§ 92.206–92.208)

DREDF appreciates the opportunity to comment on the impact of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization[57] for implementation of Section 1557 and the proposed rule in the disability community. On the one hand, it may seem that people with disabilities are neither more nor less affected than others by new onerous state restrictions on abortion access. Studies show that there is no significant difference in pregnancy[58] and abortion rates[59] between disabled and non-disabled women in the US, though data analysis in the studies also suggests that women with disabilities are at higher risk for adverse maternal outcomes and may be more likely to end a pregnancy because of health concerns.

On the other hand, a deeper understanding of pervasive ableism, intersecting systems of discrimination, and the life context for many disabled persons reveals that abortion access has particular importance[60] to people with disabilities. People with disabilities have fought for the right to self-determination and bodily autonomy through a long history of eugenics, forced medical treatment, and limited or no access to reproductive care.[61] Moreover, disabled people are much more likely to be sexually assaulted[62] and twice as likely to live in poverty.[63] Having low income and disabilities that can interfere with employment capacity means that people with disabilities have a greater likelihood of health coverage through Medicaid or Medicare, both of which are federally-funded health care programs that are subject to abortion restrictions under the Hyde Amendment.[64] Some disabled people have complex medical conditions that can make pregnancy dangerous or life-threatening. When people seeking abortion are forced to travel out-of-state, some disabled people can face the additional barrier of inaccessible transportation. Disabled people need access to abortion, and failure to provide disabled persons with meaningful access to abortion has devastating consequences.[65] Moreover, the reasoning used in Dobbs threatens privacy and many other substantive areas of law in ways that deeply implicate people with disabilities[66] and their right to make decisions about their own bodies.

People with disabilities have also confronted new barriers to medication access after Dobbs. When the Supreme Court overturned the constitutional right to abortion, it also provoked physicians and pharmacists to deny people with disabilities medications and treatments for chronic health conditions and other disabilities.[67] For example, disabled persons have been unjustifiably denied or subjected to unconscionable barriers to methotrexate, which is regularly used to treat cancer and autoimmune conditions, because the medication can also be used in medical abortions. [68] We expect that under Dobbs, people with disabilities will face increasing discriminatory denials of and barriers to an array of medications and treatments prescribed for their conditions, sometimes uniquely so because of drug interactions or the need to minimize side effects, just because the medication happens to complicate or end pregnancies or fertility.

The groundswell of health care discrimination fueled by Dobbs generally, as well as the particular implications of that discrimination for people with disabilities, demands robust implementation of the proposed rule. HHS seeks comment on whether it should address Dobbs under proposed § 92.208. We do not believe that this is the appropriate place to do so. Instead, HHS should address these issues in § 92.206 and 92.207. To proposed § 92.206(b), HHS should add provisions affirming that Section 1557 prohibits covered entities from denying, limiting access to, or otherwise placing “special” caps, costs or additional procedural requirements on medications or treatments needed by people with disabilities, irrespective of whether those medications/treatments can also be used to end or complicate pregnancies or fertility (this is primarily happening to women with disabilities of child-bearing age). The additional provisions should also address the discriminatory denial of medications and treatments used to provide abortions, manage miscarriages, and resolve ectopic pregnancies. HHS should similarly amend the text of proposed § 92.207(b)(4) and (5) to clarify that Section 1557 prohibits covered entities that provide or administer health insurance coverage or other health-related coverage from having or implementing categorical exclusions or limitations related to, otherwise denying or limiting coverage of or coverage of a claim for, or imposing additional cost sharing or other restrictions on coverage on abortions, as well as broader medications or treatments that can complicate or end pregnancies or fertility.

C. Value-Based Assessment and Purchasing Methodologies

We appreciate the request for comment[69] on value-based assessment and purchasing methodologies for drug treatments. As people with disabilities and disability advocates, we support a movement that tries to place a fair, appropriate, and sustainable value on drug treatments according to how much they benefit patients. Our concern is with certain value assessment methods that automatically begin with the premise that the benefits or life extension that a treatment brings to the lives of people with disabilities is worth less than benefits or life extension for people without disabilities.

One prime example of such a biased value assessment method is the “Quality Adjusted Life Year” (QALY). The QALY focuses on evaluating how a drug or therapy extends or improves the quality of a person’s life as a way to determine the economic worth of any given treatment. Health insurers and the 3^rd party administrators such as Pharmacy Benefit Managers (PBMs) that contract with insurers and health plans use QALY evaluations to decide if they should include a drug among a plan’s covered benefits, and to figure out the conditions that must be met for an insured beneficiary to get access to the drug. Unfortunately, the QALY bases its assessment of quality-of-life improvements and life values on subjective general public assessments on quality of life, and these assessments are deeply influenced by implicit bias and stereotypes about what it’s like to live with a disability. The actual lived experience of people with disabilities is given no account. Not surprisingly, QALY’s assign lower values to the improvements that a treatment can bring to the length and quality of life of people with disabilities, making it more likely that drugs that help disabled people to maintain their function, quality of life, and independence will “not make the cut” for being included in an insurer’s formulary, or that access to the drug will involve layers of utilization management. The National Council on Disability undertook an extensive examination on the development, use, methodology, and ethics behind QALYs, including the fundamental assumptions that underlie their use, and concluded that the use of QALYs necessarily requires accepting the discriminatory assumption that the lives of disabled persons are worth less than the lives of non-disabled persons.[70] DREDF has a legal brief[71] that examines how QALYs potentially violate federal disability rights law; to the extent that any state’s existing laws have incorporated federal disability rights law, the analysis may also be relevant to a state’s use of QALYs.

Under the ACA, the use of QALY’s to assess treatment value in Medicare and by the Patient-Centered Outcomes Research Institute (PCORI) is already restricted.[72] States, however, continue to consider use of QALYs for coverage decisions in state Medicaid programs.[73] Private insurers, as well as the PBMs they contract with, also are likely using QALYs in their coverage and benefit design decisions, without necessarily being transparent about that fact. The National Council on Disability has recommended an unequivocal ban on the use of QALYs and any value-based methodology that assigns lower values to the lives of people with disabilities and the treatments used by people with disabilities.[74]

We recommend that the examples of specific discriminatory actions under § 92.207 of the proposed rule include a reference to how a covered entity’s use of QALYs and other value-based assessment methods that assign or have the impact of assigning lower values to drug treatments/therapies that increase length or quality-of-life for people with disabilities, people of color, LGBTQ+ individuals, or older adults, for the purpose of making coverage or benefit design decisions, can be discriminatory. The Medicare program is already restricted in its use of QALYs because of the potential for violating disability rights law. By logical extension, the Medicare Advantage plans, Part D plans, and PBMs that receive Medicare dollars or any kind of federal financial assistance and that make drug coverage decisions should also be required to avoid QALYs that use discriminatory inputs.

D. Disability and Age – Administrative Exhaustion under the Age Discrimination Act

Disability becomes more common with age.[75] Or stated another way, discrimination experienced by older persons with disabilities is likely to be an intertwined product of both ageism and ableism. Since women globally tend to have a longer lifespan than men, sex discrimination also can enter the picture as women with disabilities interact with health care providers and insurers. The United Nations Special Rapporteur on the Rights of Persons with Disabilities drew special attention to older disabled women in a 2019 report,[76] noting that people in this group “are considerably poorer and more likely to be institutionalized or “incapacitated”.” And finally, we note that the sliding trap door toward institutionalization is triggered through theoretically objective health care assessments, even when implicit systemic bias may have delayed needed diagnoses and treatment for older women with disabilities, including women who face additional cultural or linguistic barriers to achieving good health. Section 1557 is its own statute, topically limited to covered entities in the field of health care and health insurance, and enforceable through a private right of action in the courts. DREDF recommends that an individual who is discriminated against on the bases of age and disability, sex, and/or another protected ground such as race, color, or national origin should not be at a disadvantage when seeking recourse under Section 1557 because of the Age Act’s administrative exhaustion requirements. We ask HHS to include regulatory language in the final rule that clarifies that administrative exhaustion is not required to bring any intersectional claim under Section 1557 that includes age as a ground of discrimination.

E. Enforcement (§§ 92.301, 92.303)

Civil rights litigation exposes discrimination in our society, but bringing a civil rights complaint or lawsuit is never an easy experience. Doing so in the arena of health care is particularly challenging for a plaintiff or plaintiffs who are in the midst of a physical or mental health crises, seeking or trying to recover from surgery, attempting to maintain functional capacity and independence in the community, or relying on insurance coverage or providers to alleviate a child’s pain or a partner’s recovery from a stroke. People with disabilities and chronic conditions know disability is a natural part of life, and that they face what is likely a thinner margin between good health and poor health in their own lives. Their encounters with inaccessible structures or equipment, ineffective communication, refusals to provide needed modifications, and implicit provider bias that denies their value as human beings take place within a broader context that can include being an older person, a person of color, LGBTQ+, and/or a Limited English Speaker. Section 1557 must offer clear, fully accessible complaint mechanisms, including directions written in plain language, for filing discrimination complaints that do not require complainants to parse out how a covered entity perceived them or responded to differing aspects of their lives. If the individual complaint must remain the primary trigger for HHS OCR’s panoply of enforcement mechanisms, from investigation to complaint review to remedial action, the filing itself must be as straightforward and helpful as possible. Disabled pregnant persons, older Black gay adults, transgender men whose preferred language is not English should all be welcome to tell their story without concern about having the right words or falling neatly into single categories of discrimination.

DREDF recommends further strengthening Section 1557’s proposed enforcement procedures by explicitly recognizing the existence of intersectional discrimination. We also recommend expanding HHS OCR’s authority to find noncompliance with Section 1557 where a covered entity, and not only health programs and activities conducted by recipients and State Exchanges, fails to comply with OCR’s information request in a timely, complete, and accurate manner. Data collection, whether required through a specific provision in the final 1557 rule or through OCR’s existing authorities or both, will be an increasingly important component of civil rights enforcement under the final rule. HHS OCR must have the authority to require full, timely, and ongoing access to the granular data compiled by covered entities as part of their compliance obligations under the final rule.

We regret that we have been unable to go into greater detail concerning our support for many other provisions in the proposed rule, particularly those that restore recognition of sexual orientation, gender identity, sex characteristics and pregnancy as protected characteristics under the protected ground of sex, as well as those provisions that return to a greater recognition of language access rights, and appreciate the need to protect older adults in Crises Standards of Care and immigrant access to health care. We support the recommendations of many of our fellow civil rights groups and their endorsement of the proposed rule and recommendations for further strengthening civil rights protections for populations and communities that experience health and health care disparities.

Thank you for the opportunity to comment on the proposed rule. We would like our comment, including any articles, studies, or other supporting materials that we have included in our comment as an active link in the text, to be included as part of the formal administrative record for the proposed rule for the purposes of the federal Administrative Procedures Act. Please let us know if HHS is unable for any reason to meet our request and include our linked materials, so we will have the chance to otherwise submit copies of the supporting documents into the record. If you have any questions about the above comments or the materials which we cite, please contact Silvia Yee at syee@dredf.org or 510-644-2555 x5234.

Sincerely,

Silvia Yee
Senior Staff Attorney

---

[1] Jason Karlawish, Hospitalized Adults Need Their Caregivers — They Aren’t Visitors (March 29, 2020), Stat.

[2] Ruth Kahn, Video Interview on the Healthcare Experiences of her Late Husband, Paul Kahn, a wheelchair and Ventilator User Who Had a Rare Degenerative neuromuscular Disability, DREDF Healthcare Stories (June 24, 2012), https://dredf.org/healthcare-stories/2012/06/24/ruth-kahn/.

[3] Alexander v. Choate, 469 U.S. 287 (1985), 295.

[4] Americans with Disabilities Act, 42 U.S.C., § 12102(a)(5).

[5] Lisa I. Iezzoni et al., U.S. Physicians’ Knowledge About the Americans with Disabilities Act and Accommodations of Patients with Disability, Health Affs. (January 2022), https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2021.01136.

[6] Rohan Khazanchi, et al., Health Affairs Forefront, Race, Racism, Civil Rights Law, and The Equitable Allocation Of Scarce COVID-19 Treatments, (February 10, 2022), DOI: 10.1377/forefront.20220208.453850.

[7] Carol K. Kane, Recent Changes in Physician Practice Arrangements: Private Practice Dropped to Less Than 50 Percent of Physicians in 2020, Policy Research Perspectives, American Medical Association, https://www.ama-assn.org/system/files/2021-05/2020-prp-physician-practice-arrangements.pdf, at 5.

[8] Id., Exhibit 4 at p. 14.

[9] Health Resources and Services Administration, Behavioral Health Workforce Projections, https://bhw.hrsa.gov/data-research/projecting-health-workforce-supply-demand/behavioral-health as of August 2022 (projecting a national shortfall of over 12,000 adult psychiatrists by 2030); Andis Robeznieks, To Overcome Doctor Shortage, Get Rid of Obstacles to Primary Care, American Medical Association (June 1, 2022), https://www.ama-assn.org/practice-management/sustainability/overcome-doctor-shortage-get-rid-obstacles-primary-care (projecting national shortages between 17,800 and 48,000 for primary care providers by 2034).

[10] Mid-Atlantic ADA Center and University of Maryland, College Park, ADA Compliance: An Exploration of Barriers and How Individuals Gain Information on the ADA, at 11, https://www.adainfo.org/wp-content/uploads/imported/Aging-Disability-ADA.pdf.

[11] Joint Commission, Advancing Effective Communication, Cultural Competence, and Patient and Family-Centered Care: A Roadmap for Hospitals, https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/health-equity/aroadmapforhospitalsfinalversion727pdf.pdf?db=web&hash=AC3AC4BED1D973713C2CA6B2E5ACD01B&hash=AC3AC4BED1D973713C2CA6B2E5ACD01B.

[12] M.L. Stransky, K.M. Jensen, M.A. Morris MA, Adults with Communication Disabilities Experience Poorer Health and Healthcare Outcomes Compared to Persons Without Communication Disabilities, J Gen Intern Med. 2018,  Dec;33(12):2147-2155. doi: 10.1007/s11606-018-4625-1. Epub 2018 Aug 24. PMID: 30143977; PMCID: PMC6258615.

[13] University of Colorado, Denver et al., Improving Communication and Healthcare Outcomes for Patients With Communication Disabilities: The INTERACT Trial, Start Date: December13, 2021, Anticipated End Date: July 2023, https://clinicaltrials.gov/ct2/show/NCT04697212.

[14] H. Steven Kaye, Internet Access by Age, Disability, and Race/Ethnicity in the US, https://dredf.org/internet-access-by-age-disability-and-race-ethnicity-in-the-us/.

[15] DREDF, Comments Submitted Re: Affordable Care Act Section 1557 Notice of Proposed Rulemaking (RIN 0945-AA02), https://dredf.docksal.site/wp-content/uploads/2015/11/DREDF-1557-NPRM-Comments-11-9-15.pdf, 12-14.

[16] US Department of Veterans Affairs, Office of Construction and Facilities Management, https://www.cfm.va.gov/til/accessibility.asp.

[17] DREDF, Comments Submitted Re: Affordable Care Act Section 1557 Notice of Proposed Rulemaking (RIN 0945-AA02), https://dredf.docksal.site/wp-content/uploads/2015/11/DREDF-1557-NPRM-Comments-11-9-15.pdf, 12-14. This argument is explained in greater detail at 8-10.

[18] Sara Rosenbaum, J. B. Teitelbaum & Katherine Hayes, Crossing the Rubicon: The Impact of the Affordable Care Act on the Content of Insurance Coverage for Persons with Disabilities, 25 Notre Dame J.L. Ethics & Pub. Pol’y 527 (2012), https://scholarship.law.nd.edu/ndjlepp/vol25/iss2/16.

[19] 527 U.S. 581, 119 S. Ct. 2176 (1999).

[20] See Townsend v. Quasim, 328 F.3d 511, 517 (9th Cir. 2003) (Olmstead integration priority applies to a program benefit when there is a major distinction in the benefit but only in where the service is provided – in the community or in an institution). Courts have recognized that Title II of the ADA and Section 504 regulations use the same integration language and have interpreted those provisions together (see Henrietta D. v. Bloomberg, 331 F. 3d 261, 272 (2d Cir. 2003); Am. Council of the Blind v. Paulson, 525 F.3d 1256, 1266 (D.C. Cir. 2008); Pashby v. Delia, 709 F.3d 307, 321 (4th Cir. 2013), lending support to the use of case law applying Title II and Olmstead to the use of integration as a nondiscrimination element that can be applied to benefit design.

[21] Jocelyn Weiner, “Go on Medi-Cal to get that”: Why Californians with Mental Illness are Dropping Private Insurance to Get Taxpayer-Funded Treatment (July 31, 2020), https://calmatters.org/projects/california-mental-health-private-insurance-medi-cal/.

[22] Section 504’s regulation explicitly recognize the need to provide services to ensure maximum integration of people with disabilities, and cases interpreting 504 have done the same, See, for example Steimel v. Wernert, 823 F.3d 902, 911 (7th Circ. 2016) (finding integration mandate violations because the Defendant’s service system design, planning, funding choices, and service implementation promoted or relied on segregation of people with disabilities); Waskul v.  Washtenaw Cnty. Cmty. Mental Health, 979 F.3d 426, 462 (6th Cir. 2020) (policies limiting plaintiffs’ access to the community and activities violated the integration mandate).

[23] Medicaid and CHIP Payment and Access Commission, Enrollment and Spending on Medicaid Managed Care, 2016, https://www.macpac.gov/subtopic/enrollment-and-spending-on-medicaid-managed-care/.

[24] Ridhi Shetti & Matt Sherer, Five Key Takeaways from New EEOC and DOJ Guidance on Disability Discrimination in Algorithm-Driven Hiring, June 3, 2022, https://cdt.org/insights/five-key-takeaways-from-new-eeoc-and-doj-guidance-on-disability-discrimination-in-algorithm-driven-hiring/.

[25] Lydia X. Z. Brown, et al., Report: Challenging the Use of Algorithm-driven Decision-making in Benefits Determinations Affecting People with Disabilities, October 21, 2020, https://cdt.org/insights/report-challenging-the-use-of-algorithm-driven-decision-making-in-benefits-determinations-affecting-people-with-disabilities/.

[26] Henry Claypool, et al., CDT and AAPD Report – Centering Disability in Technology Policy: Issue Landscape and Potential Opportunities for Action, December 13, 2021, https://cdt.org/insights/cdt-and-aapd-report-centering-disability-in-technology-policy-issue-landscape-and-potential-opportunities-for-action/.

[27] Z. Obermeyer, Dissecting Racial Bias in an Algorithm Used to Manage the Health of Populations, Science v. 366, October 25, 2019, https://www.science.org/doi/10.1126/science.aax2342.

[28] The Arc, Bazelon Center for Mental Health Law, Center for Public Representation, and Autistic Self-Advocacy Network, Ari Ne’eman, & Sam Bagenstos, Evaluation Framework for Crises Standard of Care Plans (April 8, 2020), https://autisticadvocacy.org/wp-content/uploads/2020/04/Evaluation-framework-for-crisis-standards-of-care-plans-4.9.20-final.pdf.

[29] DREDF, Preventing Discrimination in the Treatment of COVID-19 Patients: The Illegality of Medical Rationing on the Basis of Disability (March 25, 2020), https://dredf.org/the-illegality-of-medical-rationing-on-the-basis-of-disability/.

[30] Wieringa, M.A., What to Account for When accounting for Algorithms: A Systematic Literature Review on Algorithmic Accountability.” ACM [Association for Computing Machinery] Conference on Fairness, Accountability, and Transparency (FAT* ’20), January 27–30, 2020, Barcelona, Spain. ACM, New York, NY, USA, 18 pages. https://dl.acm.org/doi/abs/10.1145/3351095.3372833.

[31] Trishan Panch, Heather Mattie & Rifat Atun, Artificial Intelligence and Algorithmic Bias: Implications for

Health Systems, Viewpoints, Vol. 9, No. 2 (December 1, 2019),  https://www.jogh.org/documents/issue201902/jogh-09-020318.pdf.

[32] G.C. Alexander, Use and Content of Primary Care Office-Based vs Telemedicine Care Visits During the COVID-19 Pandemic in the US, JAMA Netw Open, October 2, 2020, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2771191.

[33] Latoya Hill, Samantha Artiga & Sweta Haldar, Key Facts on Health and Health Care by Race and Ethnicity, January 26, 2022, https://www.kff.org/report-section/key-facts-on-health-and-health-care-by-race-and-ethnicity-health-status-outcomes-and-behaviors/.

[34] CDC, Disability Impacts All of Us, September 16, 2022, https://www.cdc.gov/ncbddd/disabilityandhealth/infographic-disability-impacts-all.html.

[35] CCD, Health Task Force Telehealth Principles (July 2020), https://www.c-c-d.org/fichiers/CCD-Health-TaskForce-Telehealth-Principles-July-2020.pdf.

[36] Architectural and Transportation Barriers Compliance Board, Standards for Accessible Medical Diagnostic Equipment, January 8, 2017, https://www.regulations.gov/document/ATBCB-2012-0003-0077.

[37] US Access Board Bulletin, VA Adopts New Standards for Medical Diagnostic Equipment, April 20, 2017, https://content.govdelivery.com/accounts/USACCESS/bulletins/19450a9.

[38] May 20, 2021, https://ncd.gov/sites/default/files/Documents/NCD_Medical_Equipment_Report_508.pdf.

[39] N. R. Mudrick, L. C. Swager, M. L. Breslin, Presence of Accessible Equipment and Interior Elements in Primary Care Offices, Health Equity 3.1 (2019), https://dredf.docksal.site/wp-content/uploads/2019/10/Presence-of-Accessible-Equipment-and-Interior-Elements-in-Primary-Care-Offices.pdf.

[40] N. R. Mudrick & M.L. Breslin, ADA National Network Learning Session: The Geographic Distribution of Accessible Medicaid Participating Primary Care Offices in LA County, June 25, 2020, https://adata.org/event/ada-national-network-learning-session-geographic-distribution-accessible-medicaid.

[41] See, e.g., Silvia Yee et al., Compounded Disparities: Health Equity at the Intersection of Disability, Race, and Ethnicity, Nat’l Acads. Sci. Eng’g. & Med. 43–44 (2017),available at https://www.nationalacademies.org/our-work/the-intersections-between-health-disparities-disabilities-and-health-equity-a-workshop (summarizing and analyzing the abundance of research on this point).

[42] N. R. Mudrick, et al., Can Disability Accommodation Needs Stored in Electronic Health Records Help Providers Prepare for Patient Visits? A Qualitative Study, BMC Health Services Research (2020), https://doi.org/10.1186/s12913-020-05808-z.

[43] National Council on Disability, 2021 Progress Report: The Impact of COVID-19 on People with Disabilities, Chapter 1 and p. 85 et seq., October 29, 2021, https://ncd.gov/progressreport/2021/2021-progress-report.

[44] US Census Bureau, How Disability Data Are Collected from the American Community Survey, November 21, 2021, https://www.census.gov/topics/health/disability/guidance/data-collection-acs.html.

[45] Washington State Legislature, An Act Relating to Health System Transparency, Ch. 162, 67th Legislature, 2021 Regular Session, https://lawfilesext.leg.wa.gov/biennium/2021-22/Pdf/Bills/Session%20Laws/House/1272-S2.SL.pdf?q=20220812142537.

[46] Oregon State Legislature, Collection of Data on Race, Ethnicity, Language and Disability Status, Oregon Revised Statues, Vol. 11, Tit. 34, Ch. 413, section 413.161,  https://www.oregon.gov/oha/OEI/Policies/Data-Collection-ORS.pdf.

[47] Office of the National Coordinator for Health Information Technology, United States Core Data for Interoperability, July 3, 2022, https://www.healthit.gov/isa/sites/isa/files/2022-07/USCDI-Version-3-July-2022-Final.pdf.

[48] M. A. Morris, B. K. Swenor & S. Yee, Closing Disability Disparities: EHR Data as First Step, March 1, 2022, https://www.healthit.gov/sites/default/files/facas/2022-03-01_Documenting_disability_brief_508.pdf.

[49] Willi Horner-Johnson, et al., Perinatal Health Risks And Outcomes Among US Women With Self-Reported Disability, Health Affairs, 2022 41:10, 1477-85, https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2022.00497. DREDF notes that this article and its important findings were a pre-print from the October 3, 2022 current issue of Health Affairs. The entire issue is devoted to Disability and Health, featuring research that examines disability health and health care disparities among people with various disabilities, living in different geographic contexts in the US and around the world, and using lenses ranging from civil rights to clinical research to climate change. The issue also examines the health status and lives of people with disabilities who are transgender, who are older, and who have other diversity characteristics. This article of Health Affairs is now available at https://www.healthaffairs.org/toc/hlthaff/41/10 and will provide studies that are highly relevant to the issues addressed in the proposed rule.

[50] https://www.federalregister.gov/d/2022-16217/p-328.

[51] US Department of Health and Human Services, Health and Human Services Agencies and Offices, September 15, 2022, https://www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html.

[52] https://www.federalregister.gov/d/2022-16217/p-141.

[53] DREDF, Comments submitted to then Director Jocelyn Samuels re: Affordable Care Act Section 1557 Notice of Proposed Rulemaking (RIN 0945-AA02), https://dredf.docksal.site/wp-content/uploads/2015/11/DREDF-1557-NPRM-Comments-11-9-15.pdf.

[54] A. Sharma & L. Palaniappan, Improving Diversity in Medical Research, Nat Rev Dis Primers 7, 74 (2021),  https://doi.org/10.1038/s41572-021-00316-8.

[55] US Department of Health and Human Services, National Institutes of Health, Diversity and Inclusion in Research Trials, February 7, 2022, https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html.

[56] B. Swenor & J. A. Deal, Disability Inclusion as a Key Component of Research Study Diversity, January 20, 2022, N Engl J Med 2022; 386:205-207, https://www.nejm.org/doi/full/10.1056/NEJMp2115475; W. DeCormier Plosky, et al., Excluding People with Disabilities from Clinical Research: Criteria Lack Clarity and Justification, Health Affairs 41(10), https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2022.00520.

[57] No. 19-1392, June 24, 2022, 597 U.S. ___.

[58] J. L. Gleason, et al., Risk of Adverse Maternal Outcomes in Pregnant Women with Disabilities, JAMA Netw Open. 4(12), December 15, 2021, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787181.

[59] W. Horner-Johnson, Live Birth, Miscarriage, and Abortion Among U.S. Women With and Without Disabilities,

Disabil Health J. 10(3): 382-386, https://pubmed.ncbi.nlm.nih.gov/28431989/.

[60] Autistic Self-Advocacy Network, ASAN Condemns Supreme Court Decision in Dobbs v. Jackson Women’s Health Organization, June 24, 2022, https://autisticadvocacy.org/2022/06/asan-condemns-supreme-court-decision-in-dobbs-v-jackson-womens-health-organization/.

[61] N. Agaronnik, et al., Ensuring the Reproductive Rights of Women with Intellectual Disability, J Intellect Dev Disabil. 45(4):365-376, June 10, 2020, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8765596/.

[62] Centers for Disease Control and Prevention, Sexual Violence and Intimate Partner Violence Among People with Disabilities, June 1, 2020, https://www.cdc.gov/violenceprevention/sexualviolence/svandipv.html.

[63] N. Goodman, M. Morris & K. Boston, Financial Inequality: Disability, Race and Poverty in America, National Disability Institute (2020), https://www.nationaldisabilityinstitute.org/wp-content/uploads/2019/02/disability-race-poverty-in-america.pdf.

[64] H.R.14232 – 94th Congress (1975-1976): An Act making appropriations for the Departments of Labor, and Health, Education, and Welfare, and related agencies, for the fiscal year ending September 30, 1977, and for other purposes.

[65] Char Adams, Disability Rights Groups are Fighting for Abortion Access — and Against Ableism, NBC News, (July 21, 2022), https://www.nbcnews.com/news/us-news/disability-rights-groups-are-fighting-abortion-access-ableism-rcna38703.

[66] Autistic Self-Advocacy Network, American Association of People with Disabilities, AWN Network, Be A Hero, Disability Rights Education and Defense Fund & Little Lobbyists, Memorandum: Dobbs v. Jackson Women’s

Health Organization and Its Implications for Reproductive, Civil, and Disability Rights, June 2022, https://autisticadvocacy.org/wp-content/uploads/2022/06/Dobbs-memo.pdf.

[67] Katie Shepherd & Francis Stead Sellers, Abortion Bans Complicate Access to Drugs for Cancer, Arthritis, Even Ulcers, August 8, 2022, Washington Post, https://www.washingtonpost.com/health/2022/08/08/abortion-bans-methotrexate-mifepristone-rheumatoid-arthritis/.

[68] Laura Weiss, Pharmacists and Patients Are Freaking Out Over New Medication Restrictions Post-Roe, July 27, 2022, The New Republic, https://newrepublic.com/article/167165/dobbs-pharmacists-walgreens-methotrexate.

[69] https://www.federalregister.gov/d/2022-16217/p-938.

[70] National Council on Disability, Quality-Adjusted Life Years and the Devaluation of Life with Disability: Part of the Disability and Bioethics Series (November 6, 2019), https://www.ncd.gov/sites/default/files/NCD_Quality_Adjusted_Life_Report_508.pdf.

[71] DREDF, ICER Analyses Based on the QALY Violate Disability Nondiscrimination Law, September 21, 2021,

https://dredf.org/wp-content/uploads/2021/09/ICER-Analyses-Based-on-the-QALY-Violate-Disability-

Nondiscrimination-Law-9-17-2021.pdf.

[72] 42 USC Sec 1320e, 2017.

[73] See https://www.patientaccessproject.org/#State-Tracker.

[74] National Council on Disability, NCD Letter to Congress recommending QALY ban in Build Back Better Act, November 12, 2021, https://ncd.gov/publications/2021/ncd-letter-qaly-ban.

[75] Centers for Disease Control and Prevention Newsroom, CDC: 1 in 4 US Adults Lives with a Disability, August 16, 2018, https://www.cdc.gov/media/releases/2018/p0816-disability.html.

[76] United Nations Special Rapporteur on the Rights of Persons with Disabilities, Report on the Rights of Older Persons with Disabilities, July 17, 2019, United Nations Office of the High Commissioner of Human Rights, https://www.ohchr.org/en/calls-for-input/report-rights-older-persons-disabilities.