Proposed Rule on Nondiscrimination in Health Care Needs Public Comment

September 22, 2022

These are template comments that can be used by organizations and groups to submit comments on aspects of the proposed Section 1557 nondiscrimination rule that particularly affect people with disabilities. The template addresses many issues and includes links to supporting materials. Please do NOT feel you have to include all of these issues in your own comments! You can pick and choose the issues and sections that are of greatest concern to your organization, your staff and constituents, and the work that you do.

This template is intended only as a guide for your own comments. Feel free to use any content in this document or in the linked materials to support your organization’s comments. You can edit the template itself or copy portions into another document with your letterhead for your use. Feel free to add references to additional research, articles, and stories and experiences that you have gathered from your own employees, clients, or constituents. Your comments should have some “unique” content for the Department of Health and Human Services (HHS) to count it as a new comment. All submissions will help build a strong administrative record to support the proposed rule.

Throughout the template, you will see places in yellow highlighting that will allow you to customize your comments. You can omit any of these customization suggestions and find your own way to customize your comment but delete the yellow highlight portion if it is not replaced with your own words.

Comments can be submitted at https://www.regulations.gov/document/HHS-OS-2022-0012-0001 (click on “Comment” and then either type in your comments or attach a file). Comments are due October 3, 2022.

Contents

I. 1557 Coordinator, Policies and Procedures, Training.

II. Notices.

III. Effective and Accessible Communication.

IV. Structural Accessibility and Reasonable Modifications.

V. Nondiscrimination in Health Insurance, Benefit Design, Integrated Setting.

VI. Algorithms in Decision-Making and Telehealth.

VII. Accessible Medical and Diagnostic Equipment

VIII. Disability Data Collection.

IX. Additional Cross-Cutting Topics.

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

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

C. Value-Based Assessment and Purchasing Methodologies.

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

E. Enforcement (§§ 92.301, 92.303) 26

Conclusion.

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[Date]
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.

[ORGANIZATION NAME AND STATEMENT:

• Provide your organizational name and mission
• Explain why health care and health insurance free of discrimination is important to your organization’s work and/or the organization itself;
  • Indicate if your organization uses small group insurance and whether your disabled employees or their families face insurance discrimination
  • Indicate if your clients/constituents include people with disabilities who have been subject to discrimination and experienced harm from, for example, lack of needed coverage, underinsurance, additional charges or copays or caps on services or treatments, delays in care, and so forth
• look through the section-by-section discussions of the proposed rule below and briefly highlight the areas where your organization or the clients you serve have been most adversely affected.]

[ORGANIZATION NAME] strongly supports the proposed rule. It clarifies and strengthens nondiscrimination protections for people with disabilities and other populations that have experienced discrimination and barriers to receiving equally effective healthcare. Below is 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 thoughts 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.

I. 1557 Coordinator, Policies and Procedures, Training

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

[NAME OF ORGANIZATION] 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 pandemic provides a timely and urgent reminder of why broader and deeper awareness of civil rights is needed among healthcare 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” and turned away by security personnel, nurses, and other healthcare 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.

As an organization that works with people with disabilities seeking healthcare, we have seen

[DESCRIBE your experience as an organization or individual with making requests for auxiliary aids and services, policy modifications, or trying to get attention from a supervisor such as:

• Any time a health care employee has denied an accommodation needed for making an appointment, reaching a referral, or getting equal health care (e.g., help with undressing, filling out a form, or transferring to an exam table);
• Any time a request for an accommodation, auxiliary aids and services, or a change in policies has to made repeatedly to different personnel who then refuse or perform the request inconsistently or incompletely;
• Any time the contact information for someone with greater decision-making authority at the health care facility is denied or refused, or the person cannot be reached within an appropriate time;
• Any time the employees fail to acknowledge the relevance of printed information on federal or state civil rights law or the health facilities’ own website on the rights of people with disabilities to accessible health care, effective communication, or policy modifications.]

Violations of disability civil rights laws occur not only due to intentional ill will. They can happen because of ignorance, neglect, and administrative indifference, as noted in the findings of the Americans with Disabilities Act of 1990. 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, viewing civil rights regulations as an inconvenient add-on obligation. Fortunately, there is growing awareness across all segments of the healthcare 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.

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 healthcare 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. As of 2020, physicians aged 55 years and older were more likely than physicians under 40 years to work in small practices of 10 or fewer physicians. This is an age group that may have 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. 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.

II. Notices

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

[YOUR ORGANIZATION] 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.” [at p. 11]

Similarly, [ORGANIZATION NAME] supports including the availability of auxiliary aids and services within the language notice required under proposed § 92.11. In general, research on health and healthcare 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 among patient groups that require additional support and effective communication to achieve equitable access to healthcare. The National Health Interview Survey did not even include a specific question about communication disabilities until 2012. When that data was analyzed in 2019, the authors concluded that people with communication disabilities “represent 10% of the US population, have high rates of healthcare utilization, and experience significant disparities in health and healthcare outcomes.” Another study is currently recruiting subjects 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 healthcare, 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. 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 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.

[ORGANIZATION NAME] has heard from clients with communication disabilities who [please provide details on any of the following or similar examples:]

• Have not known that federal law prohibits health care insurers and providers from discriminating on the basis of disability.
• Have not known that health care entities who participate in Medicaid, Medicare, or state or federal exchanges are obligated to provide auxiliary aids and services, reasonable modifications, and some non-English languages;
• Have experienced barriers to receiving needed auxiliary aids and services or needed policy modifications.
• Have experienced negative health consequences such as delayed care, skipped care, inadequate instructions on medications, or incomplete examinations, for themselves or for a dependent family member because of any of the above failures to notify them of their rights.]

III. Effective and Accessible Communication

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

[ORGANIZATION NAME] 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 healthcare 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, [ORGANIZATION NAME] has seen the consequences when people with disabilities do not receive effective communication or needed auxiliary aids and services in healthcare. [Please provide any examples of:

• Instances where a person with a disability has been denied an auxiliary aid or service;
• Instances where a person with a disability receives an auxiliary aid that not effective or only partially effective, such as written notes when sign language is requested, or low-quality video relay services;
• Instances where a person has been asked to provide their own communication assistance such as a relative or friend who can interpret or read for the individual;
• Worsened health outcomes have occurred because effective communication or auxiliary aids and services were not provided.]

IV. Structural Accessibility and Reasonable Modifications

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

[ORGANIZATION NAME] supports §§ 92.203 and 92.205, which preserve prior existing requirements for structural accessibility and the provision of reasonable modifications. 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 healthcare 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.

V. Nondiscrimination in Health Insurance, Benefit Design, Integrated Setting

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

[ORGANIZATION NAME] 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, 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, just looking at the small area of durable medical equipment coverage, 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, and place stringent utilization management controls on medications that are primarily used by people with specific chronic conditions such as AIDS/HIV. 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).

Some of the discriminatory benefit designs that [ORGANIZATION NAME] sees include [describe here any exclusions, additional costs, annual caps, or unique limitations that have been imposed on your own organizations’ small group insurance or any client’s insurance. Consider especially coverage limitations that are placed on services, treatments, and devices needed by people with various disabilities, such as physical/occupational therapies, mental health treatments, prescription drugs, hearing aids, alternative communication devices, and durable medical equipment such as wheelchairs or ventilators. Also include any examples where your organization or your clients have encountered health plan provider networks that exclude or have very few providers or facilities that are in high demand among people with disabilities, such as physiatrists, in-patient rehabilitation hospitals, and so forth.]

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. Zimring. 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. The fact that it might be more convenient or less expensive to administer those treatments to institutional residents who are gathered in one location is not a factor that is relevant to clinical or medical standards of care.

At the same time, 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. Large plans that administer a range or 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 contradict a stated desire to emphasize community integration and rebalancing.

[Please provide any examples of insurance coverage policies that will only provide coverage for health care when an individual is in an institutional or nursing home setting rather than in a community-based setting, including long term care policies that provide higher dollar values for institutional coverage rather than for home and community-based settings. Please also describe any instance where your organization or clients have faced non-clinical or medical coverage restrictions or policies on when health care, treatment or devices will be provided in a home and community-based setting.]

VI. Algorithms in Decision-Making and Telehealth

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

States, health plans, and healthcare 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 healthcare 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, determination of the need for Medicaid personal care services in the home, and the ability of autonomous vehicles to recognize pedestrian wheelchair users. Race and ethnicity bias in certain algorithmic tools and AI also has been well documented. Yet, very little work has been done to understand how bias in algorithms and AI affects people with disability in healthcare even as it has the potential to profoundly affect healthcare 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 [community-based, advocacy, service, member support – please choose what applies] disability organization, [ORGANIZATION NAME] lacks the technical capacity 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 algorithms 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 that explicitly and implicitly devalued the lives of people with disabilities, chronic conditions, and specific health conditions, 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 healthcare 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, and many may continue to be so, given that they are once again out of the public eye.

We agree with the definition used by researchers that algorithmic bias is “…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,” 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.”

This approach also necessarily incorporates the potential for a covered entity to be liable for decisions based on biased algorithms or AI as long as the outcome of those decisions is biased or discriminatory. The covered entity’s 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 healthcare, 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 healthcare 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.

[ORGANIZATION NAME knows of the following examples of people with disabilities who have experienced

• Finding out that an algorithm or AI process was used to process their eligibility for a healthcare benefit such as home and community-based service hours, care coordination, or physical therapy.
• Being asked to explain to a health plan or provider why their assessment under an algorithm is incorrect.
• Not being able to find out the factors that an algorithm or AI process uses to make its assessment.]

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.

[ORGANIZATION NAME] 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, healthcare 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 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 and people with disabilities. 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. Presently large health care systems that use their own proprietary telehealth technology frequently lack the capacity to provide simultaneous embedded captions within the same video screen that is being used for the visit. 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.

[Please provide any examples you or your clients have experienced relating to inaccessible telehealth. The incidents can involve any barriers to making appointments online, effective communication during a telehealth appointment, requesting and using home test or monitoring devices for health readings such as blood pressure or pulse rate, obtaining and sending fluid or other samples to a laboratory, or getting follow-up information and care after a telehealth appointment.]

VII.Accessible Medical and Diagnostic Equipment

[ORGANIZATION NAME] 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 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 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.

California provides a unique picture of equipment inaccessibility due to its requirement for the state’s Medicaid managed care providers to undertake a 3rd 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 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. 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 healthcare appointments if they can’t bring assistants with them, whether they know their rights or not.

The ability to receive effective healthcare 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 healthcare 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.

[Organizations – please provide your own examples of encountering inaccessible equipment, making unmet requests for accessible equipment or transfer assistance, being asked to bring your own transfer assistants, being denied an appointment or a referral because accessible equipment was not available, or being incorrectly informed that equipment or assistance was available. Please also include any delays in preventive care, health consequences, or worsened health outcomes that can be traced to a lack of accessible medical diagnostic equipment.]

VIII. Disability Data Collection

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

People with disabilities are among the population groups that experience significant health disparities. They engage in preventive care at lower rates than recommended and report unmet healthcare 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 healthcare settings. Health and healthcare 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 healthcare 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 healthcare 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 healthcare 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. 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. 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) 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. 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. 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. The disability data element was included after advocates presented detailed recommendations that were included in the Interoperability Standards Workgroup Report. 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 healthcare is the lack of effective communication for patients with communication-related disabilities.

[ORGANIZATION NAME] 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.

[Please include examples or stories where you or your clients have been forced to make repeated requests for the same needed accommodation when you make or show up at health care appointments, or have been asked to establish that people with disabilities in general, or people with specific functional disabilities who have difficulty with mobility, vision, hearing, or performing activities of daily living, experience health or health care disparities.]

IX. Additional Cross-Cutting Topics

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, [ORGANIZATON NAME] 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. Somr 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. [Please include mention of any HHS Agencies or Offices that you or your clients engage with, other than the Centers for Medicare and Medicaid or OCR.]

We note and strongly support HHS’s decision to interpret Medicare Part B payments as federal financial assistance (FFA), 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. 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. [Please include any stories or experiences from your constituents or staff concerning discrimination they may have experienced from providers that only take private pay patients and Medicare patients. Include any incidences you know of where people with disabilities have been turned away by a Medicare provider on the basis of a disability or any other protected class characteristic.]

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 healthcare 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. 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. 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. 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. [Please include any stories of people with individuals who have been excluded from clinical trials and health research, even when the disability did not necessarily have any impact on the treatment that is the subject of research. Any stories about the difficulty of establishing evidence-based research for rarer conditions and the dearth of clinical research into some disabilities and chronic conditions may also be included here.]

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

[ORGANIZATION NAME] appreciates the opportunity to comment on the impact of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization 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 and abortion rates between disabled and non-disabled women in the US, though data analysis also suggests that women with disabilities 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 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. Moreover, disabled people are much more likely to be sexually assaulted and twice as likely to live in poverty. 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. 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. Moreover, the reasoning used in Dobbs threatens privacy and many other substantive areas of law in ways that deeply implicate people with disabilities 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. 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. 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.

As a disability rights organization, [we or our clients] have experienced [please provide any examples of the barriers that people with disabilities have undergone when seeking abortion, including examples that you identify as occurring before Dobbs. Please also include any stories or examples of people with disabilities who have faced new barriers to getting needed medications or treatments that also can be used for medical abortion or fertility control.]

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 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. Disability Rights Education and Defense Fund (DREDF) has a legal brief 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. States,  however, continue to consider use of QALYs for coverage decisions in state Medicaid programs. 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.

[Please include any examples you know of where people with disabilities and chronic conditions have been told that their drugs and therapies (especially rarer ones) are not covered under their insurance, have received denial letters that question the value of the drugs they are prescribed or the benefit they provide, or require plan members to jump through multiple hoops to get or maintain access to needed drugs/therapies.]

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. 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, 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 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. [ORGANIZATION NAME] recommends that an individual who is discriminated against on the bases of age and disability, sex, and/or another protected ground such as race 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. [Please add examples of older adults who are clients or constituents of your organization who have experienced intersectional discrimination when seeking health care or health insurance.]

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.  

[ORGANIZATION NAME] 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.

[Please provide specific examples of discrimination experienced by you or your clients that involve disability status and another personal characteristic such as race, sexual orientation, gender identity, transgender status, pregnancy, language spoken, or age. Explain why you or your clients need civil rights complaint procedures in health care that are straightforward and accessible, and why you think the HHS Office for Civil Rights must have full access to the data that covered entities collect under this proposed rule.]

Conclusion

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 anything in the comments or the materials, please contact [Provide the name of someone in our organization, your organization name, and an email and/or phone number as your contact information.]

Sincerely,

[The signature of your organizational director or another person with the authority to represent your organization in this comment.]

[Typed name of above signature.]