[co-author: Stephen Strobach]
To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for people with disabilities (the “MDE Regulations”).
Stressing that accessible MDE is essential for people with disabilities to have equal access to medical care and avoid poor health outcomes, the MDE Regulations, which were published by the Federal Register on August 9, 2024, amend Title II of the ADA (“Title II”) and apply to hospitals and health care clinics operated by state or local governments. The MDE Regulations create enforceable minimum standards for accessible design (as initially issued by the U.S. Access Board) covering MDE, including examination tables, weight scales, dental chairs, x-ray machines, mammography machines, and other radiological equipment commonly used for diagnostic purposes by health care professionals.
In full, the MDE Regulations and the accessibility standards they incorporate stand well in excess of 100 pages. To help our clients more readily understand what the MDE Regulations do and do not require, we are answering some of the most commonly asked questions here:
Who is covered by the MDE Regulations?
As part of Title II, which requires that state and local governments make sure that their services, programs, and activities are accessible to people with disabilities (and prohibits the exclusion from a program or the denial of benefits of services/programs/activities on the basis of disability), the MDE Regulations apply to all state or local governments (including state/local government agencies and departments), other special purpose districts, special district governments, and instrumentalities of state/local governments. This broad definition can include, among other things, public hospitals, public health care clinics, and public college and university health care systems.
Perhaps of even greater importance, these obligations can have a “trickle-down effect” insofar as state and local government entities that contract with other entities to provide public services must ensure that their contractors also comply with Title II. Therefore, if a state agency relies on a nonprofit organization to run a health clinic, that agency must make sure that the nonprofit clinic also complies with Title II.
What is MDE?
Medical diagnostic equipment is equipment used in, or in conjunction with, a medical setting by health care providers for diagnostic purposes. Examples of MDE include medical examination tables, examination chairs (including chairs used for eye or dental examinations or procedures), weight scales, mammography equipment, and imaging devices (e.g., x-ray machines, MRI machines, etc.)
What technical accessibility standards have been adopted for MDE?
DOJ has adopted the accessibility standards for MDE originally issued by the U.S. Access Board in July 2017 (the “MDE Standards”).
While the Access Board published an updated final rule regarding the low transfer height standard on July 25, 2024, DOJ did not adopt this updated rule as part of the new MDE Regulations but is considering a supplemental rulemaking to do so in the future.
The MDE Standards focus on four categories of MDE:
- The first two categories include MDE used by patients in the supine, prone, or side-lying positions (e.g., examination table) and MDE used by patients in the seated position (e.g., examination chairs), which have requirements focusing on ensuring patients can transfer from a mobility device onto/into the MDE.
- The other two categories establish technical requirements deemed necessary for a patient to use MDE while seated in a wheelchair (e.g., mammogram) or while standing (e.g., weight scale).
The MDE Standards also include technical criteria for supports (e.g., transfer, standing, leg/head/back supports), lift use, instructions/information communicated to patients through MDE, and operable parts utilized by patients.
What is the deadline for covered entities to comply with the MDE Regulations and obtain accessible MDE?
The MDE Regulations’ deadlines focus on the acquisition of new MDE and then distinguishes between general MDE and examination tables and weight scales.
- After October 8, 2024: All MDE newly acquired—via purchase, lease (or lease renewal), or other means (e.g., gifting)—by covered entities must be accessible until the entity possesses the amount of accessible MDE required by the MDE Regulations.
- By August 9, 2026: Any covered entity that uses an examination table must purchase/lease/otherwise acquire at least one accessible examination table that complies with the MDE Standards unless it already has one.
- By August 9, 2026: Any covered entity that uses a weight scale must purchase/lease/otherwise acquire at least one accessible weight scale that complies with the MDE Standards unless it already has one.
How much accessible MDE is required?
Generally, services/programs/activities of covered entities (including physician’s offices, clinics, emergency rooms, hospitals, outpatient facilities, and multiuse facilities) that use MDE must provide accessible MDE equal to at least 10 percent of the total number of units, with no fewer than one unit, of each type of equipment in use. However, for facilities that specialize in the treatment of mobility issues (e.g., rehabilitation, outpatient physical therapy, or other services/programs/activities specializing in mobility), that percentage increases to 20 percent of the total number of units, with no fewer than one of each type of equipment in use. The scoping requirements are a minimum. Covered entities may always acquire additional accessible MDE in excess of the scoping requirements.
For covered facilities with multiple departments, clinics, or specialties, the accessible MDE must be dispersed proportionately among each department, clinic, or specialty using MDE.
Are there any limits to covered entities’ need to provide accessible MDE in accordance with the MDE Regulations?
Yes, similar to other aspects of the ADA, covered entities need not make changes that would constitute a fundamental alteration or cause undue financial and administrative burdens. This conclusion must be made by the head of the covered entity or their designees after considering all resources available for use in the funding and operation of the service/program/activity and must be accompanied by a written statement of the reasons for reaching the conclusion. (Of course, any defense that relies upon cost exposes the entity to heightened discovery risks during a lawsuit or regulatory investigation.) Even when asserting these defenses, the covered entities must still take any other action that would not result in an alteration/burden but would nevertheless ensure that individuals with disabilities receive the benefits/services provided (e.g., assisting patients with transferring to the scan table so that they can receive a PET scan).
Additionally, covered entities need not take any action that would alter their equipment’s diagnostically required structural or operational characteristics and prevent their equipment from being used for its intended diagnostic purpose. The invocation of this exception does not excuse compliance with any other technical requirements that would not prevent the use of the equipment for its diagnostic purposes.
Of note, nothing in the MDE Regulations prevents the use of designs/products/technologies as alternatives to those set forth in the MDE Standards, provided they result in substantially equivalent or greater accessibility and usability of the health care services/program/activity (including any means of transfer onto/off of specific MDE). However, in such circumstances, it is incumbent upon the covered entity to demonstrate that its offerings meet/exceed the MDE Standards.
Once the proper amount of accessible MDE is acquired, are there any other related obligations?
The MDE Regulations also require the following:
- Covered entities must provide training to relevant staff on the use of accessible MDE, including training on how individuals with disabilities will transfer onto/off of specific MDE.
- Covered entities must ensure that staff can safely and effectively operate accessible MDE, assist with transfers and positioning of individuals with disabilities, and carry out the regulations for accessible MDE.
- Covered entities must also ensure that staff are able to properly use accessible MDE and are available at all times when services are provided to others.
What requirements do the MDE Regulations set forth for how covered entities utilize their existing MDE and provide overall services?
State and local government entities cannot deny health care services to a person with a disability that they would otherwise provide simply because they lack accessible MDE. As such, covered entities are still responsible for addressing barriers to access caused by a lack of accessible MDE (e.g., examination tables that cannot adjust their height). While not all MDE need be accessible, following the overarching requirements of Title II, covered entities have an obligation to operate each service, program, and activity offered through or with the use of MDE so that the service, program, and activity as a whole is readily accessible to/usable by individuals with disabilities. This obligation does contemplate a wide array of possible methods for compliance, including, among other options, reassignment of services to an alternative accessible location, home visits, delivery of services at alternative accessible sites, and the acquisition of accessible MDE. In choosing among available methods for compliance with this section, priority must be given to the methods that offer the services/programs/activities to patients with disabilities in the most integrated setting appropriate. (Please note, covered entities cannot require that a patient with a disability bring along a companion to help them as a solution unless patients without disabilities must do the same.)
Looking Ahead
As is the norm when DOJ issues new regulations, we would expect DOJ and the Access Board to offer additional guidance on the MDE Regulations and MDE Standards in the near future. Our team will be tracking these ongoing developments with an eye toward offering a webinar this fall, providing clients with an even deeper dive into the MDE Regulations and MDE Standards. Stay tuned!
[View source.]
