In May 2024, a new Final Rule regarding medical diagnostic equipment (MDE) was promulgated by the Department of Health and Human Services (HHS).[1] The rule created new requirements for accessibility of MDE used by public and private entities that receive funding from HHS including hospitals, FQHCs, clinics, emergency rooms, and Medicaid/Medicare providers (Recipients). MDE is diagnostic equipment used in health care settings like examination tables, examination chairs, weight scales, mammography equipment, x-ray machines, and other radiological equipment. The rule was implemented to decrease barriers to access to care for individuals with disabilities that prevent the use of traditional MDE.
The accessibility requirements come from the 2017 standards for accessible MDE put in place by the U.S. Access Board.[2]
The Requirements
The first deadline for compliance is coming up. By July 8, 2026, each Recipient must have at least one examination table and at least one weight scale that meets the Standards for Accessible MDE.[3]
The rule also requires that all MDE bought, acquired, or leased by a Recipient after July 8, 2024, meet the Standards for Accessible MDE, until the Recipient reaches the requisite percentage of accessible equipment. Eventually, 10% (or at least one) of MDE of non-specialized Recipients must be accessible. For Recipients that specialize in treating conditions that affect mobility, like rehabilitation centers and physical therapy providers, the requirement is 20%. These percentages are for a Recipient across all departments, clinics, and campuses, however Recipients must be mindful that even though they may have the requisite amount, that may be insufficient for meeting other requirements that patients have meaningful access to the MDE. It is considered best practice for each department, clinic, or specialty that uses MDE to have at least one piece of accessible MDE to limit instances where patients must traverse between locations.
Further, Recipients must have qualified staff who can operate accessible MDE and staff that can provide assistance to patients with disabilities when transferring to and positioning them on the equipment.
What to Do
With the first deadline quickly approaching, organization receiving HHS funding should be moving forward with acquisitions that will bring them into compliance. At this time, prior to any MDE being acquired, Recipients should be aware of whether or not they have met the requisite number or percentage of accessible equipment and if the equipment is appropriately dispersed among their locations or departments. Violations of these regulations may result in mandatory corrective action plans and private actions to enforce compliance.
We are here to help you navigate the new guidance. Please feel free to reach out with any questions.
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[2] eCFR :: 36 CFR Part 1195 -- Standards for Accessible Medical Diagnostic Equipment
[3] A Recipient that does not utilize examination tables or weight scales is not subject to this requirement.
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This publication is for general information only. It is not legal advice, and legal counsel should be contacted before any action is taken that might be influenced by this publication.
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