The US Department of Health and Human Services (HHS) and the US Department of Justice (DOJ) recently published new proposed rules that update and create various requirements under Section 504 of the Rehabilitation Act of 1973 and Title II of the Americans with Disabilities Act of 1990 (ADA). In this article, McDermott’s Healthcare Group highlights some of the biggest changes.

IN DEPTH

Furthering the Biden administration’s efforts to ensure comprehensive and equitable access to health services for individuals with disabilities, the DOJ’s Office of Civil Rights and HHS recently proposed significant updates to regulations under the ADA and Section 504 of the Rehabilitation Act of 1973.

HHS’s proposed rule under Section 504 aims to advance equity and bolster protections for people with disabilities in programs and activities that receive federal financial assistance or are conducted by a federal agency. Complementing HHS’s proposed rule, the DOJ’s Notice of Proposed Rulemaking (NPRM) under Title II of the ADA focuses on medical diagnostic equipment (MDE), establishing enforceable standards for state and local government entities providing healthcare services to address existing barriers and enhance accessibility. Together, these proposed rules represent a concerted effort by the Biden administration to further equity and accessibility in the healthcare space in a manner that will directly impact the provision of care.

HHS PROPOSED RULEMAKING ON NONDISCRIMINATION ON THE BASIS OF DISABILITY UNDER SECTION 504

As we previously reported, on September 14, 2023, HHS issued a proposed rule that updates, clarifies and strengthens the implementing regulation for Section 504, which prohibits discrimination against otherwise qualified individuals on the basis of disability in programs and activities that receive federal financial assistance or are conducted by a federal agency. Specific to entities receiving money from HHS, federal financial assistance includes credits, subsidies, or contracts of insurance, including Medicare Part A, Medicare Part C and Medicare Part D; the Children’s Health Insurance Program; the Temporary Assistance for Needy Families program; Head Start; the Supplemental Nutrition Assistance Program; childcare, foster care and adoption program; and human subjects research protection.

HHS’s proposed rule ensures that people with disabilities are not subjected to discrimination in any program or activity receiving funding from HHS, including the provision of healthcare services. HHS observed that such discrimination may occur in medical treatment, value assessment methods, child welfare programs and activities, web and mobile accessibility, accessible medical equipment, and integration for individuals with disabilities. Impacted providers should remove any barriers causing inaccessibility based on an individual’s disability. HHS proposed that noncompliance will result in penalties that may include loss of federal funding; administrative remedies such as corrective action plans, monitoring, and reporting requirements; legal action from individuals subjected to discrimination; investigations and audits; and risk of loss of accreditation or certification. More than 5,000 comments were received by the time the comment period closed on November 13, 2023. No final rule has been published to date.

DOJ’S PROPOSED RULEMAKING ON ACCESSIBILITY OF MDE

On January 9, 2024, the DOJ released an NPRM aimed at updating regulations under Title II to establish specific requirements for the accessibility of MDE and articulated the importance of coordinating its efforts with the aforementioned HHS proposed rule based on US Congress’s intent to interpret Section 504 and Title II consistently. Title II mandates that state and local government services, programs and activities be accessible to individuals with disabilities. Title II applies to all public entities, including state and local governments and departments, agencies, special purpose districts, special districts governments, and other instrumentalities of state or local government. State and local government entities that offer healthcare services, programs, and activities through the use of MDE, such as public hospitals and healthcare clinics, would be covered by this proposed rule and would also be subject to Section 504 if they receive federal funding from HHS. State and local government entities that contract with other entities to provide services (like state agencies that contract with nonprofit organizations that run clinics on the state’s behalf) also have an obligation to ensure that their contractors follow Title II, and the contractors likely would be obligated to comply in their own regard with Section 504.

MDE is equipment used in, or in conjunction with, medical settings by healthcare providers for diagnostic purposes. MDE includes examination tables, examination chairs (including chairs used for eye examinations or procedures and dental examinations or procedures), weight scales, mammography equipment and x-ray machines.

The DOJ has identified that people with disabilities continue to experience barriers to accessing medical care because of inaccessible MDE. Barriers such as exam tables that are not height adjustable, mammography machines that require a person to stand, and weight scales that do not accommodate wheelchairs result in inequities and exclusion from basic health services. The NPRM highlights five key proposals to mitigate discrimination caused by inaccessible MDE:

1. Adoption of US Access Board Standards – The proposed rule advocates for Title II to adopt the Access Board’s MDE standards as technical requirements for accessible MDE. Issued in 2017, these standards provide specific requirements for MDE accessibility in physician offices, clinics, emergency rooms, hospitals and other medical settings. The proposal would make the Access Board’s MDE standards enforceable by the DOJ under the ADA.
2. Denial of Service – The Title II proposed rule prohibits healthcare-providing state and local government entities from denying services to patients with disabilities because of a lack of accessible MDE. It also prohibits state and local government healthcare providers from requiring a patient with a disability to bring someone to assist during an examination.
3. Requirements for Newly Acquired MDE – The Title II proposed rule requires that all MDE that state and local government entities purchase, lease, or otherwise acquire after the rule goes into effect be accessible until they have a sufficient amount of accessible MDE, which the DOJ proposes to be at least 20% of equipment in mobility-treating facilities and at least 10% of other equipment. The proposal states that these entities do not need to make changes, including purchasing, leasing, or acquiring accessible MDE, if doing so would be a fundamental alteration or cause undue financial and administrative burdens. However, the existence of such a burden would not excuse a covered entity from taking another action that would ensure equitable access to the applicable benefits and services.
4. Requirements for Existing MDE – The proposed rule does not require state and local government entities to make all their existing MDE accessible. Instead, it adopts an approach analogous to the concept of program accessibility that already exists in the DOJ’s existing regulation implementing Title II. This rule would require that services, programs, or activities of state and local government entities, when viewed in their entirety, be readily accessible to and usable by individuals with disabilities, including taking meaningful actions to ensure accessibility if retrofitting existing MDE is unduly burdensome.
5. Staff Competency – The final proposal requires state and local government entities to ensure that their staff are qualified to successfully operate accessible MDE, assist with the transfer and positioning of individuals with disabilities, and carry out the rule’s requirements for existing MDE.

TIMEFRAME TO COMPLY AND PENALTIES FOR FAILURE TO COMPLY WITH THE DOJ’S PROPOSED RULE

If the DOJ’s proposed rule is adopted as written, it will require all MDE that state and local government entities purchase, lease, or otherwise acquire to be accessible until the entity has enough equipment to satisfy the rule’s 20% and 10% scoping requirements previously described. Moreover, within two years after the publication of the final rule, state and local government entities that use exam tables or weight scales would be required to have at least one exam table or weight scale that meets the MDE standards.

Failure to comply with Title II may result in penalties, such as fines of up to $75,000 for a single violation, $150,000 for additional violations, and the risk of legal action brought by individuals claiming discrimination.

CONCLUSION

These concerted efforts of HHS and the DOJ to implement rules to advance access and equitable treatment marks a significant milestone in historical efforts to remove barriers for individuals with disabilities.

Both proposed rules have been published in the Federal Register; public comments for HHS’s proposed rule closed on November 13, 2023, and comments are open for the DOJ’s proposed until February 12, 2024. Based on the 5,000 predominantly supportive comments submitted in response to the Section 504 proposed rule, we anticipate both rules will be finalized in materially the same format as proposed unless stakeholders raise material concerns.

Joshua Neumann contributed to this article.