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The MDE Standards do not impose any requirements on health care providers or medical device manufacturers; as a result, there are no compliance costs to be attributed to the MDE Standards. However, if an enforcing authority, such as the Department of Justice (DOJ), adopts the Standards as mandatory for entities under its jurisdiction, health care providers may experience some compliance costs. In addition, medical device manufacturers may have an economic incentive to produce accessible products that conform to the Standards for health care providers who need to acquire accessible medical diagnostic equipment. This section explores the costs and incentives that could result from a future adoption of the MDE Standards; however, the Access Board notes that the costs and incentives discussed in this section are purely speculative, given the lack of a statutory requirement for agencies to adopt these Standards.

6.1. Health Care Providers

Health care providers must provide individuals with disabilities “full and equal” access to their health care services and facilities under the ADA and Section 504 of the Rehabilitation Act, which prohibit discrimination on the basis of disability. Title II of the ADA (42 U.S.C. §§ 12131 to 12165) applies to state and local governments, and Title III of the ADA (42 U.S.C. §§ 12181 to 12189) applies to private entities that are public accommodations, such as health care providers. Section 504 of the Rehabilitation Act (29 U.S.C. § 792) applies to recipients of federal financial assistance such as Medicaid.

Enforcing agencies have undertaken various enforcement and guidance activities under these statutes. The Department of Justice (DOJ) has entered into settlement agreements with several major health care providers to ensure compliance with the ADA and Section 504 of the Rehabilitation Act.25 In July 2010, DOJ and the Department of Health and Human Services issued a guidance document for health care providers spelling out their responsibility to make their services and facilities accessible to individuals with mobility disabilities under the ADA and Section 504 of the Rehabilitation Act.26 The guidance document includes information on: accessible examination rooms and the clear floor space needed for individuals who use mobility devices to transfer to medical equipment; accessible medical equipment (e.g., examination tables and chairs, mammography equipment, weight scales); patient lifts and other methods for transferring individuals from their mobility devices to medical equipment; and training for health care personnel.

In July 2010, DOJ announced its intent to move toward more systematic enforcement when it issued an advance notice of proposed rulemaking (ANPRM) on accessible equipment and furniture.27 The ANPRM announced that, pursuant to the obligation that has always existed under the ADA for covered entities to provide accessible equipment and furniture, DOJ was considering amending its regulations implementing Titles II and III of the ADA to add specific standards for the design and use of accessible equipment and furniture. Among other things, the ANPRM stated that DOJ would consider adopting the standards issued by the Access Board for accessible equipment. DOJ also stated its intent to provide scoping requirements that specify the minimum number of certain types of accessible medical equipment that would be required in different types of health care facilities. If DOJ pursues its intent to amend its ADA regulations as announced in the ANPRM, it will publish a notice of proposed rulemaking requesting public comment, and it will prepare a regulatory assessment in accordance with Executive Orders 13563 and 12866.

If DOJ adopts the MDE Standards in the future, then health care providers could incur compliance costs. The amount of the compliance costs would depend on a number of factors, including the scope of equipment coverage at each health care facility and the extent that the health care provider’s equipment is not already accessible.

Additionally, as documented in the MDE Advisory Committee report and other studies, the Access Board anticipates that savings to health care providers from a reduction in injuries to health care workers (such as nurses, aides and orderlies) who are currently required to lift and/or transfer patients with mobility disabilities may offset some of the potential costs from MDE-related regulations issued by DOJ; these savings should be factored into any such analysis. Medical providers are likely to see reductions in insurance and workman’s compensation costs, as well as productivity gains from the reduced time off due to workplace injuries.

6.2. Medical Device Manufacturers

Future rulemakings, such as the one DOJ announced in its 2010 ANPRM, could affect medical device manufacturers. If health care providers are required to provide accessible medical diagnostic equipment that complies with the Standards, manufacturers may have an economic incentive to produce conforming products. The size of the incentive will depend on the health care providers’ resulting demand for accessible medical diagnostic equipment, as well as the incremental costs that manufacturers will incur as they design and manufacture products that conform to the Standards.

Many medical device manufacturers already incorporate accessibility features in some of their products, such as height-adjustable examination surfaces, transfer supports, and scales designed for use by patients seated in a wheelchair. In the case of these products, the incremental costs for manufacturers to conform to the Standards are expected to be small, because the products’ features may already meet or nearly meet the Standards. For manufacturers that do not currently incorporate accessible features into their products but plan to do so in future designs or redesigns of their products, the incremental costs may be greater. However, it is unlikely that enforcing authorities will issue standards that require MDE manufacturers to produce accessible equipment; manufacturers will thus likely remain free to choose whether or when to offer products that conform to accessibility standards that may be promulgated by other federal agencies in the future. Other manufacturers may choose not to produce accessible medical diagnostic equipment, or may produce accessible products with less market appeal than those of their competitors; in that case, they may lose market share and incur losses. Where this rule would result in a share of the market moving from one manufacturer to another manufacturer, this would represent an economic transfer as part of the rule. Where the rule would result in a manufacturer needing to undertake additional research and development, that would represent a marginal cost to the manufacturer. Where a manufacturer would lose revenue because of this rule, that lost revenue also represents a cost to the manufacturer.

While the MDE Standards impose no mandatory requirements on medical device manufacturers, the manufacturers could use the Standards as an industry best practice for accessible diagnostic equipment design. Since manufacturers periodically update product lines and features, they may incorporate more accessibility features in their products over time, which could result in lower incremental costs. By the time any enforcing agency issues regulations incorporating the Standards, more products conforming to the Standards might be readily available in the market.