28 C.F.R. § 35, app E to Part 35
Note: This appendix contains guidance providing a section-by-section analysis of the revisions to this part published on August 9, 2024.
Section-by-Section Analysis and Response to Public Comments
This appendix provides a detailed description of the Department's changes to this part (the title II regulation), the reasoning behind those changes, and responses to significant public comments received in connection with the rulemaking. The Department made changes to subpart A of this part and added subpart I to this part. The section-by-section analysis addresses the changes in the order they appear in the title II regulation.
Subpart A-General
Section 35.104 Definitions
The Department is revising § 35.104 to add definitions for the terms "medical diagnostic equipment" and "Standards for Accessible Medical Diagnostic Equipment."
MEDICAL DIAGNOSTIC EQUIPMENT
The Department is defining the term "medical diagnostic equipment," consistent with the MDE Standards, as "[e]quipment used in, or in conjunction with, medical settings by health care providers for diagnostic purposes." This definition includes the examples in 29 U.S.C. 794f , which requires the MDE Standards to set forth the minimum technical criteria for medical diagnostic equipment used in (or in conjunction with) physicians' offices, clinics, emergency rooms, hospitals, and other medical settings, and also requires the MDE Standards to apply to equipment that includes examination tables, examination chairs (including chairs used for eye examinations or procedures and dental examinations or procedures), weight scales, mammography equipment, x-ray machines, and other radiological equipment commonly used for diagnostic purposes by health professionals. These examples are illustrative of some types of MDE but are not exhaustive. The Department received one comment recommending that the Department specifically require that diagnostic equipment used by optometrists and ophthalmologists be accessible. The regulatory text explains that MDE includes examination chairs used for eye examinations or procedures, but the Department cannot and need not provide an exhaustive list of all medical specialties whose equipment is covered by subpart I of this part. Equipment is covered by subpart I if health care providers use it in, or in conjunction with, medical settings for diagnostic purposes.
The Department received several comments requesting clarification on whether the definition of "medical diagnostic equipment" applies to equipment used outside of a medical facility, such as in home settings, mobile health clinics, or through telehealth appointments or remote diagnostic assessments. Some commenters recommend that the Department explicitly state that the definition of "medical diagnostic equipment" extends to equipment used in such settings.
MDE is "[e]quipment used in, or in conjunction with, medical settings by health care providers for diagnostic purposes," and the obligations set forth in subpart I of this part apply to "service[s], program[s], or activit[ies] offered through or with the use of MDE," subject to the limitations described in subpart I. Whether a public entity needs to ensure that a specific piece of equipment used in the provision of health care services, programs, or activities in home or other settings complies with the MDE Standards would depend on the particular factual circumstances in question.
STANDARDS FOR ACCESSIBLE MEDICAL DIAGNOSTIC EQUIPMENT
The Department is defining the term "Standards for Accessible Medical Diagnostic Equipment" in accordance with the standards promulgated by the Access Board on January 9, 2017, under section 510 of the Rehabilitation Act of 1973, as amended, and codified on July 1, 2017, found at 36 CFR part 1195 (revised as of July 1, 2017). That is the version of the Access Board's MDE Standards that was in effect when the Department issued its notice of proposed rulemaking (NPRM).[1] The Department is not, however, adopting two provisions that were included in the January 9, 2017, version of the Access Board's standards, M301.2.2 and M302.2.2 ("the sunset provisions"). The sunset provisions stated that the 17-inch to 19-inch low transfer height range set forth in M301.2.1 and M302.2.1 would cease to have effect on January 10, 2022.[2] Accordingly, if the definition of the MDE Standards that the Department is adopting did not exclude the sunset provisions, there would be no enforceable minimum low transfer height standard, since this final rule is being promulgated after January 10, 2022. By adopting the January 9, 2017, version of the MDE Standards that was codified on July 1, 2017, but excluding the sunset provisions, the Department is adopting and making enforceable the 17-inch to 19-inch low transfer height range set forth in M301.2.1 and M302.2.1 of the January 9, 2017, version of the MDE Standards. Under the final rule, public entities acquiring accessible MDE have the option of acquiring MDE that lowers to between 17 inches and 19 inches. However, under § 35.212(a), public entities are required to operate their services, programs, and activities that use MDE so that they are readily accessible to and usable by individuals with disabilities, regardless of whether the entities' MDE lowers to 17 inches or 19 inches.
Several commenters submitted comments on the low transfer height requirement. One commenter recommended that the Department make the temporary low transfer height range a permanent requirement. Some commenters expressed concern about the feasibility of complying with a 17-inch low transfer height standard, and several other commenters said the Department should adopt a 17-inch low transfer height standard in anticipation of the Access Board finalizing a 17-inch standard. As noted in the previous paragraph, the Department is adopting the 17-inch to 19-inch low transfer height range, without adopting the sunset provisions. The Department believes it is appropriate to adopt the MDE Standards promulgated by the Access Board, which were the product of a multi-year deliberative process. As to the comments supporting or opposing a 17-inch low transfer height standard, the Access Board had not yet issued a final rule establishing a 17-inch low transfer height standard when the Department issued its NPRM. Therefore, it would have been premature for the Department to have sought public comment on or proposed adopting the 17-inch standard in the NPRM, and the Department declines to adopt and make enforceable such a standard in the final rule without public comment. As noted in section II.C of the preamble to the final rule, however, since the Access Board has now issued a final rule updating the low transfer height standard, the Department will consider issuing a supplemental rulemaking under title II proposing to adopt it, and the Department will solicit comments on the updated standard as part of any such rulemaking.
Some commenters urged the Department to work with the Access Board to account for the needs of particular disability groups more explicitly. Commenters asked that the Department consider more specifically the needs of individuals with nonmobility disabilities, people with respiratory disabilities, people who are blind or have other sensory disabilities, higher weight people, and people with intellectual disabilities. The MDE Standards account for the needs of individuals with nonmobility disabilities to some extent,[3] and any new standards to account for additional disabilities or factors that the Access Board did not incorporate into the MDE Standards should be developed by the Access Board, which has authority to promulgate such standards under section 510. The Department notes that the Access Board received comments recommending that the MDE Standards address "individuals with autism, Alzheimer's, sensory disabilities, cognitive disabilities, and bariatric patients," and noted that while it could not accommodate those comments in this round of rulemaking, it committed to "address[ing] other barriers in future updates to the MDE Standards." [4] Therefore, while the Department appreciates commenters' viewpoints, it declines to update this part to account for additional disabilities or factors at this time.
The Department also received many comments from diverse stakeholders on whether the Department should apply the Access Board's MDE Standards to medical equipment that is not used for diagnostic purposes. Many commenters supported applying the MDE Standards to nondiagnostic medical equipment, especially equipment used for therapeutic or treatment purposes. Other commenters urged the Department not to expand the requirements beyond MDE at this time. Some commenters also stated that the Department lacks technical expertise to unilaterally impose technical standards on a broad range of nondiagnostic medical equipment. One commenter recommended that if the Department adopts enforceable standards regarding the accessibility of nondiagnostic medical equipment, the Department should first explain its proposed approach in detail to allow for additional public input on the types of nondiagnostic medical equipment to which those standards would apply.
The Department agrees that any extension of the MDE Standards to nondiagnostic medical equipment, or the adoption of any new standards for nondiagnostic medical equipment, should be informed by the Access Board's extensive knowledge and technical acumen, as well as by additional public input. If, in the future, the Department adopts enforceable technical standards concerning the accessibility of nondiagnostic medical equipment, it will consult with the Access Board and other Federal partners and make clear to covered entities what types of equipment will be required to meet those standards. But because the Access Board has not developed specific technical standards regarding the accessibility of nondiagnostic medical equipment, and given the need to provide public entities with clarity about the scope of any standards the Department is adopting, the Department declines to adopt enforceable technical standards for nondiagnostic medical equipment or otherwise extend the Access Board's standards at this time.
The Access Board's standards apply only to equipment that is used in, or in conjunction with, medical settings by health care providers for diagnostic purposes. As noted in the NPRM, equipment used for both diagnostic purposes and other purposes (such as therapeutic or treatment purposes) is MDE if it otherwise meets this definition, and must therefore meet the requirements for accessible MDE set forth in subpart I of this part. The Department will continue to consider whether to conduct further rulemaking in the future.
Several commenters emphasized the importance of accessibility in the provision of health care services that use medical equipment, whether that equipment is used for diagnostic purposes or not. The Department clarifies that public entities are already obligated to ensure that their services, programs, and activities do not exclude or discriminate against individuals with disabilities and are readily accessible to and usable by individuals with disabilities.[5] This obligation encompasses the provision of health care services by public entities, whether those services use MDE or not.
Subpart I-Accessible Medical Diagnostic Equipment
The Department is creating a new subpart in its title II regulation. Subpart I of this part addresses the accessibility of public entities' medical diagnostic equipment.
Section 35.210 Requirements for Medical Diagnostic Equipment
This section provides general accessibility requirements for services, programs, and activities that public entities provide through or with the use of MDE. Public entities must ensure that their services, programs, and activities offered through or with the use of MDE are accessible to individuals with disabilities.
Under this general provision (barring an applicable limitation or defense), a public entity that provides health care cannot deny services that it would otherwise provide to a patient with a disability because the provider lacks accessible MDE. A provider also cannot require a patient with a disability to bring someone along with them to help during an examination if similar requirements are not imposed on patients without disabilities. A patient may choose to bring another person such as a friend, family member, or personal care aide to an appointment, but regardless, the provider may need to provide reasonable assistance to enable the patient to receive medical care.[6] Such assistance may include, for example, helping a person who uses a wheelchair to transfer from their wheelchair to the examination table or diagnostic chair.[7] The provider cannot require the person accompanying the patient to assist.
Individuals and groups, including disability advocacy organizations, individuals with disabilities and their family members, health care providers and associations, and manufacturers of medical equipment, submitted comments on the Department's proposed rule. Overwhelmingly, the commenters expressed strong support for adopting the MDE Standards and requiring public entities to ensure that their services, programs, and activities offered through or with the use of MDE are accessible to individuals with disabilities.
Many commenters described the importance of accessible MDE and provided firsthand accounts of instances when they or their family members were unable to receive health care or received substandard health care because providers lacked accessible examination tables, weight scales, or radiological or other diagnostic equipment. Several commenters recounted instances when they or their family members were unable to receive preventative health care services such as mammograms, prostate examinations, or dental examinations. Other commenters noted that they could not have their weight checked regularly because of the lack of accessible weight scales, resulting in health care risks such as a failure to provide the amount of medication required. Some commenters described entities' expectations that individuals with mobility disabilities would be accompanied by companions to physically transfer them onto MDE. Disability advocacy groups also shared representative accounts submitted by their members, documenting the harms experienced by people with disabilities due to health care providers' lack of accessible MDE.
The Department agrees with commenters that accessible MDE is vital for health equity, person-centered care, and access to medical care for patients with disabilities. As discussed in the NPRM, research has documented that the scarcity of accessible MDE constitutes a significant barrier to access to care for patients with disabilities, resulting in a failure to provide adequate preventative health care and diagnostic examinations.[8]
As explained in more detail in the NPRM, the Department is aware of many instances in which people with disabilities were denied access to needed care, were subjected to demeaning situations, or received substandard care because health care providers lacked accessible MDE.[9] The Department has taken action to enforce the ADA as it applies to the provision of health care services.[10] However, the lack of technical standards for accessible MDE before the Access Board issued the MDE Standards in 2017, and the fact that, until now, the MDE Standards were not enforceable under title II, mean that these circumstances remain all too prevalent. Section 35.210 will help clarify public entities' nondiscrimination obligations as they pertain to services, programs, and activities that use MDE.
Section 35.211 Newly Purchased, Leased, or Otherwise Acquired Medical Diagnostic Equipment
For MDE that public entities purchase, lease, or otherwise acquire after October 8, 2024, which is 60 days after the publication of the final rule in the Federal Register, the Department is adopting an approach that draws on the approach that the existing title II regulation applies to new construction and alterations of buildings and facilities.[11] Section 35.211(a) requires that all MDE that a public entity purchases, leases, or otherwise acquires more than 60 days after publication must be accessible, unless and until the scoping requirements set forth in more detail in § 35.211(b) are satisfied.
As in the fixed or built environment, the accessibility of MDE is governed by a specific set of design standards promulgated by the Access Board that sets forth technical requirements for accessibility. So long as a public entity has the amount of accessible MDE set forth in the scoping requirements, the public entity is not required to continue to obtain accessible MDE when it purchases, leases, or otherwise acquires MDE after the final rule's effective date. However, a public entity may choose to acquire additional accessible MDE even after it satisfies the scoping requirements.
Section 35.211(a) Requirements for Newly Purchased, Leased, or Otherwise Acquired Medical Diagnostic Equipment
Paragraph (a) adopts the January 9, 2017, version of the Access Board's MDE Standards that was codified on July 1, 2017 (with the exception of the Access Board's sunset provisions, as explained in the section-by-section analysis of the definition of the term "Standards for Accessible Medical Diagnostic Equipment" in § 35.104 ), as the standard governing whether MDE is accessible, and establishes one of the key requirements of subpart I of this part: that subject to applicable limitations and defenses, all MDE that public entities purchase, lease, or otherwise acquire more than 60 days after the publication of the final rule must meet the MDE Standards unless and until the public entity already has a sufficient amount of accessible MDE to satisfy the scoping requirements in § 35.211(b).
As explained in more detail in section II.C of the preamble to the final rule ("Overview of Access Board's MDE Standards"), the MDE Standards include technical criteria for equipment that is used when patients are (1) in a supine, prone, or side-lying position; (2) in a seated position; (3) in a wheelchair; or (4) in a standing position. They also contain standards for supports, communication, and operable parts. In addition, the MDE Standards contain requirements for equipment to be compatible with patient lifts where a patient would transfer under positions (1) and (2).
Consistent with the language in 29 U.S.C. 794f(b) , MDE covered under subpart I of this part includes examination tables, examination chairs (including chairs used for eye examinations or procedures and dental examinations or procedures), weight scales, mammography equipment, x-ray machines, and other radiological equipment commonly used for diagnostic purposes by health professionals. As noted in the section-by-section analysis of § 35.104 , subpart I of this part covers medical equipment used by health professionals for diagnostic purposes even if it is also used for treatment purposes. Given the many barriers to health care that people with disabilities encounter due to inaccessible MDE, adopting the MDE Standards will give many people with disabilities an equal opportunity to participate in and benefit from public entities' health care services, programs, and activities.
In the NPRM, the Department sought comment on whether 60 days is an appropriate amount of time for these requirements to take effect. A number of commenters said 60 days is the right amount of time, including one commenter who recommended no more than 60 days and another who recommended no less than 60 days. However, a few commenters thought 60 days would not be enough time to comply with these requirements. Those commenters expressed concern that it could be difficult for public entities to obtain accessible MDE and carry out this section's requirements within 60 days, and that a 60-day requirement would be too burdensome for small or under-resourced public entities in particular. One commenter said 60 days is the right amount of time for MDE that does not require construction, but that a longer timeframe should apply to MDE that necessitates construction in the room in which the MDE will be located, such as magnetic resonance imaging ("MRI") scanners. One commenter recommended 180 days, not 60 days, to give public entities time to carry out this section's requirements, and asked the Department to clarify whether public entities will be expected to comply with the scoping requirements set forth in § 35.211(b) upon the effective date of the final rule or later. The commenter recommended that public entities be given at least two years from the final rule's publication date to achieve compliance with the scoping requirements.
The Department agrees with the majority of commenters who commented on this issue and concludes that 60 days is the appropriate amount of time for the requirements set forth in § 35.211(a) to take effect because it strikes an appropriate balance between the immediate and urgent health care needs of individuals with disabilities and the constraints facing public entities. Therefore, all MDE that public entities acquire more than 60 days after publication shall meet the MDE Standards, unless and until the scoping requirements in § 35.211(b) are met. In response to the commenters who are concerned that a 60-day time period will be too burdensome, the Department notes that public entities are not required to take steps that would result in an undue burden or a fundamental alteration, as set forth in more detail in § 35.211(e). The Department also notes that public entities have been on notice since the NPRM was issued in January 2024 that the Department was considering imposing this requirement, giving them time to prepare to carry out the requirements of subpart I of this part.
The Department also clarifies that, once it takes effect 60 days after publication, § 35.211(a) will only require MDE to meet the MDE Standards if it is acquired after the effective date (subject to the scoping requirements and the other requirements and limitations of subpart I of this part). That means, for example, that if a public entity does not acquire any MDE until 180 days after publication, the MDE that the entity acquires 180 days after publication will be required to meet the MDE Standards (assuming the entity has not already met the scoping requirements and no limitations apply), but the entity's existing MDE will not be required to meet the MDE Standards. In other words, although the timeframe set forth in § 35.211(a) is 60 days after publication, the question of when a particular public entity's MDE will be required to meet the MDE Standards will depend on when the entity acquires MDE after publication, which could be more than 60 days after publication. This reinforces the Department's conclusion that 60 days is the appropriate amount of time for § 35.211(a) to take effect.
The Department also clarifies that to "purchase, lease, or otherwise acquire" MDE more than 60 days after publication means to acquire MDE by any means. A few commenters requested that the Department make clear that leases include lease renewals, and that acquisitions include acquisitions in any form, including, but not limited to, acquisitions via gifts or loans, as well as both temporary and permanent acquisitions. To avoid any confusion, the Department is clarifying in the § 35.211(a) regulatory text that the term "lease" includes the renewal of existing leases. The Department's intent is that the term "lease" includes lease renewals, and it is modifying the § 35.211(a) regulatory text to avoid any confusion. The Department also agrees with commenters that to "purchase, lease, or otherwise acquire" MDE in the context of subpart I of this part means to acquire MDE through any means, including, but not limited to, acquisitions via donations or loans, as well as both temporary and permanent acquisitions. This intent is reflected by the term "otherwise acquire" in the regulatory text.
Section 35.211(b) Scoping
Section 35.211(b) establishes scoping requirements for accessible MDE. Accessibility standards generally contain scoping requirements (how many accessible features are needed) and technical requirements (what makes a particular feature accessible). For example, the 2010 ADA Standards provide scoping requirements for how many toilet compartments in a particular toilet room must be accessible and provide technical requirements on what makes these toilet compartments accessible.[12] The MDE Standards issued by the Access Board contain technical requirements, but they do not specify scoping requirements. Rather, they state that "[t]he enforcing authority shall specify the number and type of diagnostic equipment that are required to comply with the MDE Standards." [13] For the technical requirements to be implemented and enforced effectively, it is necessary for the Department to provide scoping requirements to specify how much accessible MDE is needed for a public entity's health care service, program, or activity to comply with the ADA.
Paragraphs (b)(1) through (3) of § 35.211 lay out scoping requirements for this section. The scoping requirements that the Department is establishing are based on the requirements that the 2010 ADA Standards establish for accessible patient sleeping rooms and parking in hospitals, rehabilitation facilities, psychiatric facilities, detoxification facilities, and outpatient physical therapy facilities.[14] Because public entities must comply with title II of the ADA, many public entities are likely already familiar with these standards.
The Department drew on the following approaches from the 2010 ADA Standards in formulating the scoping requirements for the final rule. According to the 2010 ADA Standards, licensed medical care facilities and licensed long-term care facilities where the period of stay exceeds 24 hours shall provide accessible patient or resident sleeping rooms and disperse them proportionately by type of medical specialty.[15] Where sleeping rooms are altered or added, the sleeping rooms being altered or added shall be made accessible until the minimum number of accessible sleeping rooms is provided.[16] Hospitals, rehabilitation facilities, psychiatric facilities, and detoxification facilities that do not specialize in treating conditions that affect mobility shall have at least 10 percent of their patient sleeping rooms, but no fewer than one sleeping room, provide specific accessibility features for patients with mobility disabilities.[17] Hospitals, rehabilitation facilities, psychiatric facilities, and detoxification facilities that specialize in treating conditions that affect mobility must have 100 percent of their patient sleeping rooms provide specific accessibility features for patients with mobility disabilities.[18] In addition, at least 20 percent of patient and visitor parking spaces at outpatient physical therapy facilities and rehabilitation facilities specialized in treating conditions that affect mobility must be accessible.[19] Several of these approaches are reflected in the scoping requirements adopted in paragraph (b) of § 35.211 for MDE.
Paragraph (b)(1) of § 35.211 provides the general requirement for physicians' offices, clinics, emergency rooms, hospitals, outpatient facilities, multi-use facilities, and other medical services, programs, and activities that do not specialize in treating conditions that affect mobility. When these entities use MDE to provide services, programs, or activities, they must ensure that at least 10 percent, but no fewer than one unit, of each type of equipment complies with the MDE Standards. For example, a medical practice with 20 examination chairs must have 2 examination chairs (10 percent of the total) that comply with the MDE Standards. In a medical practice with five examination chairs, the practice must have one examination chair that complies with the MDE Standards (because every entity covered by this provision must have no fewer than one unit of each type of equipment that is accessible). If a dental practice has one x-ray machine, that x-ray machine must be accessible. However, these requirements do not apply until an entity newly acquires MDE, as explained in the section-by-section analysis of § 35.211(a).
Paragraph (b)(2) of § 35.211 provides the scoping requirement for rehabilitation facilities that specialize in treating conditions that affect mobility; outpatient physical therapy facilities; and other medical services, programs, and activities that specialize in treating conditions that affect mobility. This paragraph requires that at least 20 percent of each type of MDE used in these types of services, programs, and activities, but no fewer than one unit of each type of MDE, must comply with the MDE Standards. Because these facilities specialize in treating patients who are likely to need accessible MDE, it is reasonable for them to be required to have more accessible MDE than is required for the health care providers covered by paragraph (b)(1), who do not have the same specialization. As with paragraph (b)(1), the scoping requirements of paragraph (b)(2) do not apply until an entity newly acquires MDE.
The Department received many comments on the scoping percentages in § 35.211(b)(1) and (2). Many commenters acknowledged the need to provide accessible MDE and supported the inclusion of scoping requirements. Some commenters expressed concern that the scoping requirements could have a profound financial and operational impact on small hospitals, potentially leading to reduced availability of essential diagnostic services in rural and underserved areas; expressed concern about the amount of accessible MDE currently available on the market; or requested more time to acquire MDE that meets the MDE Standards and resources to help health care providers comply. Many other commenters, including disability advocates and disability rights organizations, voiced concerns that the scoping provisions are too low to meet demand among people with mobility disabilities. Without a requirement that a larger percentage of MDE or 100 percent of MDE be accessible, they asserted that patients with disabilities will have fewer scheduling options or longer wait times than nondisabled patients. One commenter also stated that it would be simpler and clearer to require all newly acquired MDE to be accessible. Another commenter noted that while it would be ideal for all MDE to be accessible, this would place an undue burden on health care providers, and the needs of individuals with disabilities can be fully addressed if health care providers have some accessible MDE and engage in proper planning to prevent delays and denials in the delivery of health care services.
Many of the commenters who viewed the scoping requirements as too low objected to modeling the scoping requirements on the requirements that the 2010 ADA Standards establish for accessible patient sleeping rooms and parking in hospitals, rehabilitation facilities, psychiatric facilities, detoxification facilities, and outpatient physical therapy facilities. Those commenters cited factors such as the prevalence of disability; the belief that accessible MDE is more in demand than accessible parking spaces; and the fact that, unlike accessible parking spaces, accessible MDE can also be used by nondisabled individuals. Some commenters suggested instead modeling the scoping requirements on the "replacement rule" that applies to transportation services under title II, which requires that all newly purchased and leased vehicles be readily accessible to and usable by people with disabilities.[20] Other commenters suggested different approaches, such as imposing higher scoping requirements for MDE that is used to provide preventive services outlined by the U.S. Preventive Services Task Force, or imposing higher scoping requirements for MDE that is used more frequently.
While several commenters opposed having different scoping requirements in § 35.211(b)(1) and (2), others supported the approach of imposing a higher scoping requirement in § 35.211(b)(2) (for facilities that specialize in treating conditions that affect mobility) than in § 35.211(b)(1) (for other facilities). Other commenters noted the importance of considering the department and type of facility in formulating the scoping requirements.
The Department appreciates all of the comments on the scoping requirements in § 35.211(b). The Department acknowledges the concerns of commenters who believe health care providers might have difficulty complying with the scoping requirements, as well as the countervailing concerns of commenters seeking more stringent scoping requirements. As discussed in section III.A.2 of the preamble to the final rule, the Department certifies that the final rule will not have a significant impact on a substantial number of small entities. While the Department appreciates that the final rule may result in increased demand for accessible MDE, commenters did not submit data to suggest that the market cannot bear the additional demand. In any case, if equipment that meets the MDE Standards is unavailable, the fundamental alteration or undue burdens limitations may apply, as explained in § 35.211(e).
The Department recognizes that there are many potential models on which it could base its scoping requirements and acknowledges that the needs underlying the accessible parking model are not perfectly aligned with the needs underpinning accessible MDE. However, the Department continues to believe that the use of MDE is analogous to the use of parking spaces at rehabilitation facilities because, as with parking spaces, several different patients with mobility disabilities can use the same piece of MDE in a day.
As explained in the NPRM, the Department considered whether to require 100 percent of MDE in these programs to be accessible, like section 223.2.2 of the 2010 ADA Standards, which requires that 100 percent of patient sleeping rooms in similar facilities provide specific accessibility features for patients with mobility disabilities. The Department concluded that the time-limited use of MDE is more analogous to the use of parking spaces at a rehabilitation facility than to the use of sleeping rooms because, unlike MDE, sleeping rooms are generally occupied for all or a significant part of the day. Thus, § 35.211(b) draws on the 2010 ADA Standards' scoping requirements by requiring, in § 35.211(b)(1), at least 20 percent (but no fewer than one unit) of each type of equipment in use in facilities that specialize in treating conditions that affect mobility to meet the MDE Standards, and requiring, in § 35.211(b)(2), at least 10 percent (but no fewer than one unit) of each type of equipment in use in other facilities to meet the MDE Standards. Imposing higher scoping requirements for facilities that specialize in the treatment of conditions that affect mobility has proven to be a workable framework in the context of the 2010 ADA Standards' scoping requirements, and the Department believes this will also be a helpful framework for the MDE scoping requirements.
In view of demands on provider entities,[21] the Department will not increase the scoping requirements beyond 10 percent for § 35.211(b)(1) and 20 percent for § 35.211(b)(2) at this time. The Department does not agree with several commenters who opined that the use of MDE is analogous to the use of vehicles covered by the ADA title II transportation accessibility requirements. MDE often cannot be retrofitted to be accessible with the same ease or cost ratio as transportation retrofits. For example, inaccessible weight scales typically do not have large platforms that are required for wheelchair access. Inaccessible examination tables are usually fixed height "box" tables with static bases, and possibly drawers, that cannot easily be replaced with adjustable mechanisms.[22] The Department therefore declines to adopt an approach akin to the "replacement rule" that applies in the title II transportation accessibility context, which would require that 100 percent of newly acquired MDE be accessible.[23] And although one commenter suggested relying on the U.S. Preventive Services Task Force recommendations, the Department does not believe that these recommendations would serve as a useful basis for the scoping requirements in § 35.211(b). The U.S. Preventive Services Task Force makes evidence-based recommendations on clinical preventive services and health promotion in primary care settings,[24] but those recommendations are not primarily about the use of MDE and therefore do not serve as a useful model for scoping requirements related to MDE.
The Department also does not believe it is necessary to impose higher scoping requirements for MDE that is used more frequently than other types of MDE, as some commenters suggested. Providers are likely to have more units of the types of MDE that are used more frequently, and the more units of MDE a provider has, the more units will need to be accessible according to the scoping requirements.
The Department therefore will not increase the scoping requirements set forth in § 35.211(b) at this time or eliminate the distinction between the general scoping requirements in § 35.211(b)(1) and the scoping requirements for facilities that specialize in treating conditions that affect mobility in § 35.211(b)(2). The Department notes that, because paragraph (b) requires that at least one unit of each type of MDE in use meet the MDE Standards irrespective of the percentage requirements, some smaller health care providers will be required to have a proportion of accessible MDE that exceeds 10 percent for paragraph (b)(1) or 20 percent for paragraph (b)(2). For example, barring an applicable limitation or defense, a provider with two dental chairs will be required to have at least one dental chair that meets the MDE Standards, which is 50 percent of the provider's total.
The Department also clarifies that the scoping requirements set forth in § 35.211(b) must be read in conjunction with the requirements set forth elsewhere in subpart I of this part. Section 35.210 prohibits public entities from excluding, denying benefits to, or otherwise discriminating against people with disabilities in services, programs, or activities that use MDE, and § 35.212 requires that each service, program, or activity that uses MDE be readily accessible to and usable by people with disabilities in its entirety, independent of the scoping requirements for newly acquired MDE set forth in § 35.211(b). That means, for example, that denying a physical examination to a patient with a disability because of the lack of accessible MDE may violate the nondiscrimination obligation set forth in § 35.210, even if the scoping requirements set forth in § 35.211(b)(1) and (2) have not yet been triggered by the new acquisition of MDE. As another example, if, even after a provider complies with the scoping requirements set forth in § 35.211(b)(1) and (2), patients with disabilities have significantly fewer scheduling options than nondisabled patients, that could implicate the obligation in § 35.212 to make public entities' services, programs, and activities readily accessible to and usable by individuals with disabilities. Public entities may determine that the most effective way to carry out the obligations set forth in §§ 35.210 and 35.212 will be to acquire additional accessible MDE beyond the scoping requirements set forth in § 35.211(b)(1) and (2).
Finally, one commenter requested clarification on whether the required number of units of accessible MDE should be rounded up or down if application of the scoping percentages does not yield a whole number. If application of the scoping percentages yields a number less than one, the number will need to be rounded up to one because § 35.211(b)(1) and (2) require that no fewer than one unit of each type of equipment in use meet the MDE Standards. If application of the scoping percentages yields a number greater than one, the standard mathematics rule on rounding decimals to whole numbers applies to the scoping requirements in § 35.211(b)(1) and (2).[25]
Section 35.211(b)(3) addresses facilities or programs with multiple departments, clinics, or specialties. In any facility or program that has multiple departments, clinics, or specialties, where a service, program, or activity utilizes MDE, the accessible MDE required by paragraphs (b)(1) and (2) shall be dispersed proportionately across departments, clinics, or specialties. For example, a hospital that is required to have five accessible x-ray machines cannot place all the accessible x-ray machines in the orthopedics department and none in the emergency department. This dispersion requirement is analogous to the existing title II ADA regulation that requires dispersion of accessible sleeping rooms in medical care facilities that do not specialize in the treatment of conditions that affect mobility.[26]
Section 35.211(b)(3) does not require that accessible MDE be dispersed with exact mathematical proportionality, which at times would be impossible. Section 35.211(b)(3) also does not require public entities to acquire additional MDE, beyond the amount specified in paragraphs (b)(1) and (2), to ensure that accessible MDE is available in every department, clinic, and specialty. This approach is consistent with many provisions of the 2010 ADA Standards.[27] Additionally, if § 35.211(b)(3) were to require full dispersion across every department, clinic, and specialty, it could create inconsistency or confusion between the dispersion and scoping requirements. For example, if a health care program that operated out of three clinics was required to have two units of accessible MDE according to the scoping provisions, then if paragraph (b)(3) required public entities to disperse their accessible MDE across every department, clinic, and specialty, the entity could meet the scoping requirements but would nonetheless violate the dispersion requirements because the two units of accessible MDE that the scoping provision required would not be enough to fully disperse across all three clinics. If paragraph (b)(3) required public entities to disperse fully across every department, clinic, and specialty, it could also be difficult to determine whether more precise dispersion requirements had been met. For example, a clinic may be part of a department and also part of a specialty (or include providers with multiple specialties), so determining whether accessible MDE was dispersed with precision across each department, clinic, and specialty could become complex.
Even if a public entity's facility or program with multiple departments, clinics, or specialties will not be able to disperse its accessible MDE with mathematical precision across every department, clinic, and specialty, public entities must still afford people with disabilities an opportunity to benefit from each type of medical care that is equal to the opportunity provided to people without disabilities.[28] The Department recognizes that it is critically important for people with disabilities to have access to all types of medical care. Therefore, public entities are still required to ensure that all of their services, programs, and activities are accessible to and usable by individuals with disabilities, regardless of whether the dispersion provision in paragraph (b)(3) requires a specific department, clinic, or specialty to have accessible MDE.
The Department appreciates the comments it received on its proposed dispersion requirements. Though some commenters supported the Department's proposed approach to dispersion, many commenters did not believe the dispersion requirements were sufficient to meet the needs of individuals with disabilities. These commenters felt that additional requirements should be added to ensure adequate dispersion. Commenters proposed a range of different requirements, including requirements for each department or specialty; for every floor and building; for each facility; for every subpart of a larger entity that has the capacity to manage its own booking system; and for a particular geographic radius. Some commenters also proposed that each department, clinic, or specialty be required to have one or two examination tables and weight scales. One commenter supported a flexible approach to dispersion, whereby accessible MDE would be made available where it is needed.
For the reasons discussed in the section-by-section analysis of § 35.211(b), the Department continues to believe that the approach to dispersion set forth in § 35.211(b)(3) is appropriate and consistent with existing law. In light of the demands that increased dispersion requirements would impose on public entities, the Department is not expanding the dispersion requirements at this time. However, the Department emphasizes that compliance with the dispersion requirement does not excuse public entities from complying with their nondiscrimination obligations under the existing title II regulation or §§ 35.210 and 35.212.
The National Council on Disability, an independent Federal agency charged with advising the President, Congress, and other Federal agencies on policies, programs, practices, and procedures that affect people with disabilities, stated that the Department should require that as a facility or program acquires accessible MDE, it should ensure that at least one accessible examination table and one weight scale are located in every department, clinic, or specialty. The Department declines to adopt this suggestion so that public entities will retain the flexibility to determine how they will comply with the dispersion requirements in § 35.211(b)(3), in light of each public entity's particular circumstances. Though the text of § 35.211(b)(3) requires public entities to disperse, in a proportionate manner, the accessible MDE required by paragraphs (b)(1) and (2), the Department encourages public entities to disperse all of their accessible MDE proportionately, where they have more accessible MDE than paragraphs (b)(1) and (2) require.
Other commenters proposed that the Department require the dispersion of equipment or personnel other than MDE, such as wheelchairs that can be used around MRI scanners and patient lifts or transfer teams, as well as the dispersion of MDE based on weight or size capacity. The Department declines to adopt requirements for the other types of dispersion proposed by these commenters at this time. In this rulemaking, the Department is adopting the January 9, 2017, version of the MDE Standards promulgated by the Access Board [29] (with the exception of the sunset provisions, as explained in the section-by-section analysis of § 35.104 ) and making those standards enforceable. The MDE Standards do not include requirements for wheelchairs, equipment with greater weight or size capacity, patient lifts, or transfer teams. The Department will relay the commenters' views to the Access Board for consideration if the Access Board revises the MDE Standards on this subject in the future.
Many commenters raised concerns about the burdens that the approach to dispersion in subpart I of this part could impose on people with disabilities. These included delays in diagnosis and care, with the possibility of associated harm to the patient's health or life; increased wait times; cancelled or rescheduled appointments; a lack of expertise if patients need to receive some care from other departments or specialties; less effective treatment; the need for accessible, affordable transportation to other locations where accessible MDE is available; a lack of choice for patients with disabilities about where they will receive care; a lack of privacy if accessible MDE is located in a shared space; and embarrassment, humiliation, frustration, stress, and pain.
The Department reiterates that the lack of additional or more specific dispersion requirements than those set forth in § 35.211(b)(3) does not excuse public entities from complying with their nondiscrimination obligations under the existing title II regulation or §§ 35.210 and 35.212. If public entities' dispersion of accessible MDE imposes the burdens on individuals with disabilities that some commenters described, then that situation could result in discrimination because the public entity's MDE is not readily accessible to and usable by persons with disabilities as required by § 35.210. Likewise, such a situation could result in the public entity's service, program, or activity in its entirety not being readily accessible to and usable by patients with disabilities as required by § 35.212. Public entities are encouraged to acquire additional accessible MDE and disperse that MDE across departments, clinics, and specialties to better meet the needs of patients with disabilities.
One commenter proposed that the Department adopt a specific limit on wait times to ensure that people with disabilities do not have to wait significantly longer to access services than people without disabilities because of the amount of accessible MDE in a particular location or because patients need to travel to a different location to use accessible MDE. The Department declines to adopt a specific wait time limit because whether a particular wait time is justifiable may depend on the circumstances, including the overall demand for services and the wait times experienced by patients without disabilities. However, the Department notes that if patients with disabilities experience significantly longer wait times than patients without disabilities seeking comparable services at comparable times, this could violate § 35.210 or § 35.212.
Other commenters asked the Department to require public entities to offer and pay for accessible transportation when patients need to travel to other locations to use accessible MDE. The Department declines to adopt this requirement at this time because it has concluded that the requirements set forth elsewhere are sufficient to address the commenters' concerns. More specifically, a failure to provide accessible transportation when patients with disabilities need to travel to other locations to use accessible MDE, but nondisabled patients do not need to travel to other locations to receive care, or a requirement that patients incur additional costs to use accessible MDE, could violate § 35.210 or § 35.212 or more generalized nondiscrimination requirements in the existing title II regulation.[30]
Many commenters also raised concerns about the burdens that the approach to dispersion in § 35.211(b)(3) may impose on public entities. Some commenters stated that it might be difficult or impossible for some types of MDE to be moved, but commenters also noted that some types of MDE might be more portable or easily shared. A few commenters stated that there might not be sufficient space in some existing medical facilities for accessible MDE. Other commenters noted potential difficulties that may arise if public entities share accessible MDE between clinics or departments. These include delays and increased wait times; the need to identify, locate, move, and track accessible MDE; the need to transport patients; the need to recalibrate MDE after it is moved; unnecessary work for staff to locate or move accessible MDE if the patient who needed it has to reschedule; conflicts among multiple patients or departments who need the accessible MDE; last-minute needs for accessible MDE; and the need to determine how to provide care if shared accessible MDE is not available. While the Department acknowledges and appreciates the concerns raised by these commenters, it declines to change the dispersion requirement of paragraph (b)(3) because, for all of the reasons already stated, it finds that the current requirement is appropriate. Further, some of the challenges noted by these commenters might be mitigated by exercising the flexibility public entities retain to determine how they will meet the dispersion and nondiscrimination requirements in subpart I of this part, so long as they satisfy the minimum scoping requirements in § 35.211(b)(1) and (2).
Commenters also stated that, to share or move accessible MDE, patients would need to provide notice of their need for accessible MDE when booking an appointment and opined that booking systems and public information should clearly indicate where and when accessible MDE is available. At this time, the Department declines to adopt additional procedural requirements that certain information about the availability of accessible MDE be made available or that the need for accessible MDE be recorded as part of the booking process because public entities should have flexibility to meet the requirements of subpart I of this part in a manner that is appropriate to their resources and systems. However, it may be helpful or necessary for public entities to request information about patients' needs and make information about accessible MDE available to patients and staff where feasible. Doing so is likely to better position public entities to provide care in a nondiscriminatory manner, while enabling patients with disabilities to make informed decisions about their care. Providing information to staff about the availability of accessible MDE may also enable public entities to meet their other obligations under subpart I of this part, including the obligation in § 35.213 to ensure that their staff are able to carry out the program accessibility obligation set forth in § 35.212.
The Department recognizes there may be situations in which a public entity's facility or program shares one piece of a particular type of accessible MDE among all departments, clinics, or specialties. In a small facility or program with a limited number of departments, clinics, or specialties in the same building, that situation may provide equal access for all patients with disabilities who need accessible MDE. However, depending on the circumstances, it may be necessary or advisable to have at least one unit of accessible MDE in each department, clinic, or specialty, so that patients with disabilities do not need to traverse between departments, clinics, or specialties for care. The Department recognizes the varying circumstances of different public entities and health care settings. Whether a public entity can share accessible MDE between departments, clinics, or specialties and still carry out its obligations under subpart I of this part will depend on the circumstances.
Public entities must ensure that the dispersion of their accessible MDE does not discriminate against people with disabilities. If a public entity requires a patient with a disability who needs accessible MDE to use the MDE of another department, clinic, or specialty, or to use MDE in a different location, the public entity must ensure that the MDE and the service, program, or activity in its entirety are readily accessible to and usable by the patient, as required by §§ 35.210 and 35.212. Factors to consider in determining whether this standard has been met may include, among other things, whether the MDE is readily available and not a significant distance from where the patient is seeking care; whether changing locations during the patient visit significantly increases wait times; whether the patient is required to be undressed or partially dressed to use the MDE (if, for example, the patient has to go to a different part of the same building to use the accessible MDE); and whether the public entity provides assistance in moving between locations.
A public entity may be able to take other measures to ensure that its MDE and its services, programs, and activities in their entirety are readily accessible to and usable by patients with disabilities. For example, it could offer home visits that provide equal access to care or accessible transportation to patients with disabilities at no cost to them within a reasonable timeframe.
Section 35.211(c) Requirements for Examination Tables and Weight Scales
Section 35.211(c) sets forth specific requirements for examination tables and weight scales. Paragraph (c)(1) requires public entities that use at least one examination table in their service, program, or activity to purchase, lease, or otherwise acquire, within two years after the publication of this part in final form, at least one examination table that meets the requirements of the MDE Standards, unless the entity already has one. Similarly, paragraph (c)(2) requires public entities that use at least one weight scale in their service, program, or activity, to purchase, lease, or otherwise acquire, within two years after the publication of this part in final form, at least one weight scale that meets the requirements of the MDE Standards, unless the entity already has one. This requirement is subject to the other requirements and limitations set forth in § 35.211. Thus, § 35.211(c) does not require a public entity to acquire an accessible examination table and an accessible weight scale if doing so would result in a fundamental alteration in the nature of the service, program, or activity or in undue financial and administrative burdens, as explained in § 35.211(e) and (f). In addition, public entities may use designs, products, or technologies as alternatives to those prescribed by the MDE Standards if the criteria set forth in § 35.211(d) are satisfied.
The Department received many comments in support of the requirements set forth in § 35.211(c), including comments from public entities and individuals with disabilities. Many commenters provided firsthand accounts of being unable to receive health care or receiving substandard care because of a lack of accessible examination tables or weight scales. Commenters also described receiving incomplete physical examinations because they could not transfer to an examination table, or forgoing routine examinations, such as abdominal palpations and breast examinations, due to a lack of accessible examination tables. Some noted that many medicines, including chemotherapy and anesthesia, are dosed based on weight, yet a lack of accessible weight scales makes it impossible for many people with disabilities to be accurately weighed. Similarly, disability advocacy groups shared representative accounts of harms that people with disabilities have experienced due to the inaccessibility of examination tables and weight scales.
Some commenters expressed concern that the requirements set forth in § 35.211(c) are insufficient. A few commenters urged the Department to require public entities to obtain more than one examination table or weight scale, particularly in facilities that focus on conditions that affect mobility. Other commenters asked the Department to require one examination table and weight scale per department, clinic, or specialty. The Department clarifies that the requirements in § 35.211(c) must be viewed in conjunction with the other requirements of subpart I of this part. For example, although § 35.211(c) requires public entities to obtain at least one accessible examination table and at least one accessible weight scale within two years, public entities may be required to obtain more than one examination table or weight scale based on the scoping requirements set forth in § 35.211(b). In addition, public entities are subject to the nondiscrimination and program access obligations in §§ 35.210 and 35.212, and the acquisition of multiple accessible examination tables or weight scales may be the most effective way to satisfy those obligations.
The Department requested public comment on the potential impact of the requirements in § 35.211(c) on people with disabilities and public entities. Several disability advocacy groups wrote that there are accessible weight scales on the market at varying costs, and that covered entities can also purchase or lease refurbished weight scales. The National Council on Disability commented that the economic impact on public entities will be modest and will be offset by the positive economic impact of more people being able to access preventative care. One commenter who uses a wheelchair noted that frequent delays during medical appointments due to a shortage of accessible examination tables and weight scales cost her money by preventing her from working.
Offering a different perspective, a few commenters expressed concern that it will be too expensive or logistically burdensome for providers to acquire the accessible MDE that § 35.211(c) requires. Some commenters suggested that the Department help providers pay for accessible MDE, including accessible examination tables and weight scales.
While the Department acknowledges the concerns of health care providers that will be required to carry out the obligations set forth in § 35.211(c), giving providers two years to meet the requirement for examination tables and weight scales, in particular, will improve access to basic diagnostic services for individuals with disabilities, while permitting providers to plan for the costs. Many of the comments that the Department received that describe the experiences of people with disabilities demonstrate the need for this requirement and the harm that a lack of accessible examination tables and weight scales can cause.
Regarding commenters' concerns about the cost of compliance, the Department does not currently operate a grant program to assist public entities in complying with the ADA. However, the Department notes that, pursuant to § 35.211(e), public entities are not required to take any action that would result in a fundamental alteration in the nature of a service, program, or activity, or in undue financial and administrative burdens. Given the availability of these limitations, the Department believes it is appropriate to retain the requirements set forth in § 35.211(c).
Regarding whether two years is an appropriate amount of time for entities to comply with the requirements in § 35.211(c), commenters had diverse perspectives. While many commenters agreed with the Department's choice of two years, some, including individuals with disabilities, the National Council on Disability, and disability advocacy groups, stated that two years is too long. Others stated that two years is not long enough for public entities to comply with this requirement, particularly if entities have limited resources or if equipment is not readily available. Some commenters suggested a phased implementation approach.
Given the health disparities and barriers to care facing individuals with disabilities,[31] and the importance of examination tables and weight scales for the provision of basic health care services, the Department does not believe an extension of the two-year requirement or a phased implementation period for particular types of public entities is warranted. The fundamental alteration and undue burdens provisions account for the difficulty that some entities might have complying with the requirements of subpart I of this part.
The Department also does not believe a period shorter than two years for compliance with § 35.211(c) is warranted. Although the Department recognizes that individuals with disabilities face urgent health care needs, the Department must also consider the ability of entities to budget for and obtain accessible examination tables and weight scales under a feasible timeframe. Given all of these factors, the Department finds it appropriate to impose a two-year timeline for complying with the requirements for examination tables and weight scales in § 35.211(c).
The Department notes, however, that even before the two-year requirement goes into effect, public entities are required to make their services, programs, and activities, including those that use MDE, accessible to people with disabilities. Even before the two-year deadline, if an entity denies a physical examination or fails to take an accurate weight because of a lack of an accessible examination table or weight scale, that may implicate the nondiscrimination obligation set forth in § 35.210 and the program access obligation set forth in § 35.212, as well as the obligations set forth in the existing title II regulation.
Some commenters, including a State entity, the National Council on Disability, and multiple disability advocacy groups, expressed concern that, other than examination tables and weight scales, public entities are not required to obtain additional types of MDE within a specified period of time. The Department imposed a two-year requirement for examination tables and weight scales because those two types of equipment are very common among primary care providers, important for a range of basic diagnostic health services, and relatively attainable compared to more expensive accessible imaging equipment.[32] Many people with disabilities are unable to receive even the most basic health care services because of inaccessible examination tables and weight scales. In view of demands on provider entities, particularly small practices and rural facilities, the Department will not require public entities to obtain accessible MDE other than examination tables and weight scales within two years. Public entities will, however, be required to ensure that other types of MDE are accessible when they are acquired in accordance with § 35.211(a), and they will be required to comply with §§ 35.210 and 35.212. And as discussed elsewhere in this appendix, the most effective way to carry out the requirements set forth in §§ 35.210 and 35.212 may be to acquire multiple types of accessible MDE, not only examination tables and weight scales.
Section 35.211(d) Equivalent Facilitation
Paragraph (d) of § 35.211 specifies that a public entity may use designs, products, or technologies as alternatives to those prescribed by the MDE Standards, for example, to incorporate innovations in accessibility. However, this provision applies only where the use of the alternative designs, products, or technologies results in substantially equivalent or greater accessibility and usability of the health care service, program, or activity than the MDE Standards require. It does not permit a public entity to use an innovation that reduces access below what the MDE Standards would require. The responsibility for demonstrating equivalent facilitation rests with the public entity.
Several commenters wrote in support of the equivalent facilitation provision in § 35.211(d). A couple of commenters suggested that the Department clarify that use of equivalent facilitation must not result in improved access to one group of people with disabilities at the expense of reduced access for others. The Department agrees that this provision does not apply if the use of an alternative design, product, or technology would make the health care service, program, or activity less accessible or usable for individuals with disabilities (or any group of individuals with disabilities) than the MDE Standards require.
The same commenters also recommended that the Department require entities to individually assess the preferences and needs of people with disabilities and receive informed consent before using an alternative option. The Department declines to require entities to individually assess the preferences and needs of people with disabilities and receive informed consent before using alternative designs, products, or technologies. This provision is modeled on existing language in the ADA Standards.[33] Adopting the approach that commenters proposed would create inconsistency between subpart I of this part and other portions of the Department's title II regulation,[34] which does not include the requirements for equivalent facilitation that commenters suggested. Further, requiring entities to engage in that sort of assessment with current or prospective patients could create an unworkable framework for public entities that had already obtained products that afforded equivalent or greater accessibility than the MDE Standards. However, nothing in this part requires patients to receive diagnostic health care services that they would prefer not to receive.
Section 35.211(e) Fundamental Alteration and Undue Burdens
Paragraph (e) of § 35.211 addresses the fundamental alteration and undue financial and administrative burdens limitations. While subpart I of this part generally requires public entities to adhere to the MDE Standards when newly purchasing, leasing, or otherwise acquiring MDE, it does not require public entities to take steps that would result in a fundamental alteration in the nature of their services, programs, or activities or in undue financial and administrative burdens. These limitations mirror the existing title II regulation at § 35.150(a)(3) . If a particular action would result in a fundamental alteration or undue burdens, the public entity is obligated to take any other action that would not result in such an alteration or such burdens but would nevertheless ensure that individuals with disabilities receive the benefits or services the public entity provides.
Many commenters wrote in support of the fundamental alteration and undue burdens limitations, with some noting that the approach strikes a thoughtful balance that will promote equal access to MDE for people with disabilities while mitigating the challenges and costs of implementation for public entities. While some commenters objected to the cost of complying with subpart I of this part, others said cost and acquisition difficulties should not be an excuse for noncompliance. A few commenters wrote that it is unlikely that an entity will reasonably be able to rely on these limitations at all. Some commenters wrote that people with disabilities historically have been forced to carry the burden, and the provision should consider the burden on people with disabilities in terms of factors like wait times, extra costs, and the availability of accessible providers. Some commenters asked the Department to clarify or define certain terms, such as "undue burden" or "fundamental alteration." One comment suggested a particular method for making an undue burden calculation.
A few commenters recommended that the Department establish exceptions according to a different framework. One suggested that the Department exempt whole categories of entities, including small practices, new practices, and practices in areas with a health professional shortage. Others suggested that the Department extend the compliance timeframes for certain categories of entities, including small, rural, and "safety-net" entities.
The Department acknowledges commenters' concerns that the fundamental alteration and undue burdens limitations will undermine access for people with disabilities. However, these limitations fall within the well-established title II framework,[35] and it is important for these limitations on obligations to remain consistent with part 35 as a whole. These limitations also require a more individualized inquiry than the categorical exceptions that some commenters suggested and will therefore strike a better balance between the accessibility needs of individuals with disabilities and the potential difficulties of compliance in particular circumstances. As noted in the preceding paragraphs, if an action would result in a fundamental alteration or undue burdens, the public entity must still take any other action that would ensure that individuals with disabilities receive the benefits or services the public entity provides.
Because fundamental alteration and undue burdens are longstanding limitations under the ADA,[36] members of the public and public entities should already be familiar with these limitations in other contexts. The Department has provided guidance that addresses the fundamental alteration and undue burdens limitations, and will consider providing more in the future.[37] The Department's existing guidance documents provide details on fundamental alteration and undue burdens determinations, including language explaining that such determinations should consider all resources available for use in the funding and operation of the service, program, or activity.[38] In the Department's view, this guidance will help public entities use the fundamental alteration and undue burdens limitations appropriately.
Section 35.211(f) Diagnostically Required Structural or Operational Characteristics
Paragraph (f) of § 35.211 incorporates what M201.2 of the Access Board's MDE Standards refers to as a General Exception.[39] The paragraph states that, where a public entity can demonstrate that compliance with the MDE Standards would alter diagnostically required structural or operational characteristics of the equipment, preventing the use of the equipment for its intended diagnostic purpose, compliance with the Standards would result in a fundamental alteration and therefore is not required.
In the NPRM, the Department sought comment on whether the proposed exception in § 35.211(f) is needed. Multiple commenters supported the Department's approach, describing it as "thoughtful" and "balance[d]." Other commenters disagreed with this exception and recommended that the Department remove or amend it, stating that the exception is unnecessary, that it will be an overused loophole, or that it will stifle innovation.
While the Department appreciates commenters' opinions and concerns and recognizes the importance of providing accessible MDE to people with disabilities, the Department continues to believe that this exception is sometimes needed to preserve the functionality of MDE. For instance, as noted in the NPRM, the Department is aware that certain positron emission tomography ("PET") machines cannot meet the MDE Standards' technical requirements for accessibility and still serve their diagnostic function. Commenters did not provide information that called this into question. Rather, the Department received numerous comments, including several comments regarding radiological diagnostic services, stating that this exception is essential. These commenters expressed concern that the MDE Standards are incompatible with the safe design and use of some types of diagnostic imaging equipment. With respect to MRI machines in particular, a disability rights organization observed that structural attributes may prevent certain equipment from being made accessible, and noted the importance of providing alternatives to ensure accessibility for individuals who use metal wheelchairs or assistive equipment.
In light of these factors, the Department will retain the exception in § 35.211(f). The Department expects, however, that this exception will apply only in rare cases. In such circumstances, the public entity must still take any other action that would not result in a fundamental alteration or undue burdens but would nevertheless ensure that individuals with disabilities receive the services, programs, or activities the public entity provides. For example, a PET machine that could not meet the MDE Standards and still serve its diagnostic function would not be required to meet the MDE Standards as a whole, but the public entity would still be required to meet all other applicable provisions of the MDE Standards, and to take any other action that would ensure that individuals with disabilities receive the public entity's benefits or services without fundamentally altering the nature of the service, program, or activity, or imposing undue financial and administrative burdens. Such actions could include, for example, assisting patients with transferring to the scan table so that they can receive a PET scan.
With respect to a commenter's concern that this exception will stifle innovation, the Department appreciates both the value of innovation and the importance of ensuring that MDE used by individuals with disabilities can be used safely and in accordance with its intended diagnostic purpose, given the constraints of existing technology. The Department believes § 35.211(f) strikes an appropriate balance between these interests. Further, the reason for allowing for equivalent facilitation in § 35.211(d) is to encourage flexibility and innovation by public entities while still ensuring equal or greater access to MDE.
In addition to commenters who recommended that the Department eliminate the exception in § 35.211(f), some commenters suggested changes to the regulatory text. One commenter suggested that the regulatory text should include language from the section-by-section analysis relating to the rare use of the provision and assistance transferring to a PET machine. The Department declines to incorporate these points into the regulatory text. Because the forgoing discussion reflects the Department's expectation about the rare applicability of this provision, and because the discussion about PET scans is one representative example, this discussion is more appropriately situated in this appendix than in the regulatory text.
A few commenters asked the Department to require that, where equipment's structural or operational characteristics implicate the fundamental alteration limitation, covered entities must consider all possibilities to ensure the dignity and independence of the person with a disability. The Department declines to amend the regulatory text to explicitly state that public entities must consider all possibilities to ensure the dignity and independence of people with disabilities. While the Department encourages public entities to do so to the extent feasible, the Department believes that the obligations set forth in the regulatory text in §§ 35.210 and 35.212, when read together with the ADA and the general prohibition on discrimination in its implementing regulation, are sufficient to prevent discrimination without further changes to this section.[40]
Section 35.212 Existing Medical Diagnostic Equipment
In addition to the requirements for newly purchased, leased, or otherwise acquired MDE, § 35.212 requires that public entities address access barriers resulting from a lack of accessible MDE in their existing inventory of equipment. Here subpart I of this part adopts an approach analogous to the concept of program accessibility in the existing regulation implementing title II of the ADA.[41] Under this approach, public entities may make their services, programs, and activities available to individuals with disabilities, without extensive retrofitting of their existing buildings and facilities that predate the regulation, by offering access to those programs through alternative methods. The Department adopts a similar approach with respect to MDE to provide flexibility to public entities, address financial concerns about acquiring new MDE, and at the same time ensure that individuals with disabilities will have access to public entities' health care services, programs, and activities.
Section 35.212 requires that each service, program, or activity of a public entity, when viewed in its entirety, be readily accessible to and usable by individuals with disabilities. Section 35.212(a)(1) makes clear, however, that a public entity is not required to make each piece of its existing MDE accessible. Like § 35.211(e), § 35.212(a)(2) incorporates the concepts of fundamental alteration and undue financial and administrative burdens. As addressed in more detail in the discussion of these limitations in the section-by-section analysis of § 35.211(e), the fundamental alteration and undue burdens provisions do not excuse a public entity from addressing the accessibility of the program. If a particular action would result in a fundamental alteration or undue burdens, the public entity is still obligated to take any other action that would ensure that individuals with disabilities are able to receive the public entity's benefits and services. As with the fundamental alteration and undue burdens limitations, the discussion of the exception relating to diagnostically required structural or operational characteristics contained in the section-by-section analysis of § 35.211(f) applies equally to the Department's approach to this exception in § 35.212(a)(3).
The Department is also correcting a typographical error in § 35.212(a)(3). Section 35.212(a)(3) states that an entity meets its burden of proving that compliance with § 35.212(a) would result in a fundamental alteration under § 35.212(a)(2) if it demonstrates that compliance with § 35.212(a) would alter diagnostically required structural or operational characteristics of the equipment and prevent the use of the equipment for its intended diagnostic purpose. The NPRM mistakenly referred to § 35.211(a) and (c) rather than to § 35.212(a).
Section 35.212(b) describes various methods by which public entities can make their services, programs, and activities readily accessible to and usable by individuals with disabilities when the requirements set forth in § 35.211 have not been triggered by the new acquisition of MDE. Of course, the purchase, lease, or other acquisition of accessible MDE may often be the most effective way to achieve program accessibility. However, except as stated in § 35.211, a public entity is not required to purchase, lease, or otherwise acquire accessible MDE if other methods are effective in achieving compliance with subpart I of this part.
For instance, if doctors at a medical practice have staff privileges at a local hospital that has accessible MDE, the medical practice may be able to achieve program accessibility by ensuring that the doctors see a person with a disability who needs accessible MDE at the hospital, rather than at the local office, so long as the person with a disability is afforded an opportunity to participate in or benefit from the service, program, or activity equal to that afforded to others. Similarly, if a medical practice has offices in several different locations, and one of the locations has accessible MDE, the medical practice may be able to achieve program accessibility by serving the patient who needs accessible MDE at that location. However, such an arrangement would not provide an equal opportunity to participate in or benefit from the service, program, or activity if it was, for example, significantly less convenient for the patient or if the visit to a different location resulted in higher costs for the patient.
Similarly, if the scoping requirements set forth in § 35.211(b) require a public entity's medical practice to have three accessible examination tables and an accessible weight scale, but the practice's existing equipment includes only one accessible examination table and one accessible scale, then until the practice must comply with § 35.211, the practice can ensure that its services are readily accessible to and usable by people with disabilities by establishing operating procedures such that, when a patient with a mobility disability schedules an appointment, the accessible MDE can be reserved for the patient's visit. In some cases, a public entity may be able to make its services readily accessible to and usable by individuals with disabilities by using a patient lift or a trained lift team, especially in instances in which a patient cannot or chooses not to independently transfer to the MDE in question.[42]
If a public entity carries out its obligation under § 35.212(a) to make a service, program, or activity readily accessible to and usable by people with disabilities by purchasing, leasing, or otherwise acquiring accessible MDE, then that newly purchased, leased, or otherwise acquired MDE must comply with the requirements set forth in § 35.211.
Several commenters recommended that the Department include more specificity regarding the methods by which public entities must make their services, programs, and activities readily accessible to and usable by individuals with disabilities. For example, one commenter suggested that the Department establish a clear and defined test to assess compliance with the program access obligation. Another commenter suggested that the Department establish thresholds to determine whether public entities provide an equal opportunity to participate in or benefit from the service, program, or activity. Citing the Department's statement in the NPRM that allowing a patient to use accessible MDE at an alternative location would not give a patient with a disability an equal opportunity to participate in or benefit from the service, program, or activity if it was significantly less convenient or resulted in higher costs for the patient, the commenter suggested that the Department define how inconvenient an alternative location must be, either in terms of distance or in terms of travel time, in order to violate § 35.212(a).
The Department acknowledges these concerns and the commenters' desire for more clearly defined parameters, but notes that the concept of services, programs, and activities being readily accessible to and usable by individuals with disabilities is a longstanding requirement under title II of the ADA in other contexts.[43] Therefore, members of the public and State and local governments should already be familiar with this obligation. The Department has also provided guidance that addresses this concept,[44] and will consider providing more in the future. The Department operates a toll-free ADA Information Line that the public can call for assistance understanding the requirements of the ADA. The question of whether a particular service, program, or activity, in its entirety, is readily accessible to and usable by individuals with disabilities will be an inherently fact-bound inquiry.
Some commenters recommended that the Department require public entities to engage in an interactive process with patients and consider patients' preferences and needs in determining how to carry out their program access obligations. An "interactive process" is a term of art that applies in the ADA title I context but not the ADA title II context, and the Department declines to require such a process in subpart I of this part.[45] However, it may often be helpful or necessary for public entities to consider patients' preferences and needs in order to ensure that the entity's services, programs, and activities, in their entirety, are readily accessible to and usable by individuals with disabilities. For example, using the scenario discussed in the preceding paragraphs, a medical practice that lacks accessible MDE at its primary location might be able to achieve program accessibility by serving a patient who needed accessible MDE at an alternative location. But the practice would first need to determine how difficult it would be for the patient to travel to the alternative location. As explained in the preceding paragraphs, if the alternative location was significantly less convenient or resulted in higher costs for the patient, it would not provide an equal opportunity to participate in or benefit from the service, program, or activity.
One commenter asked whether public entities can continue to use existing MDE that meets some but not all of the requirements set forth in the MDE Standards. The commenter asked whether, for example, an entity can use an adjustable height examination table that lowers to the minimum height but does not raise to the upper height set forth in the MDE Standards. As § 35.212(b) explains, § 35.212(a) does not require public entities to acquire MDE that meets all of the requirements set forth in the MDE Standards if other methods enable them to make their services, programs, and activities, in their entirety, readily accessible to and usable by individuals with disabilities. Using MDE that meets some but not all of the requirements set forth in the MDE Standards may, in some cases, be one way for public entities to carry out their program access obligation under § 35.212(a). In contrast, newly acquired MDE must meet all of the requirements set forth in the MDE Standards pursuant to § 35.211(a), absent an applicable limitation.
Finally, one commenter recommended that the Department add a requirement from the ADA title III regulations that "a public accommodation shall remove architectural barriers in existing facilities where such removal is readily achievable, i.e., easily accomplishable and able to be carried out without much difficulty or expense." [46] The readily achievable barrier removal standard applies to architectural barriers, not barriers in equipment, and importing requirements from the ADA title III regulation into subpart I of this part could create confusion and inconsistency with the other obligations in subpart I and with the rest of the title II regulation. Additionally, MDE often cannot be retrofitted to be accessible with the same ease or cost ratio as many forms of readily achievable barrier removal, such as adding raised markings to elevator buttons or providing paper cups at an inaccessible water fountain. The Department therefore declines to import the readily achievable barrier removal standard into the final rule.
Section 35.213 Qualified Staff
Section 35.213 requires public entities to ensure that their staff members are able to successfully operate accessible MDE, assist with transfers and positioning of individuals with disabilities, and carry out the program access obligation with respect to existing MDE. This will enable public entities to carry out their obligation to make the programs, services, and activities that they offer through or with the use of MDE readily accessible to and usable by individuals with disabilities. The Department believes that public entities must have, at all times when services are provided to the public, appropriate and knowledgeable personnel who can operate MDE in a manner that ensures services are available and timely provided. Often, the most effective way for public entities to ensure that their staff members are able to successfully operate accessible MDE is to provide staff training on the use of MDE, but the final rule does not mandate that approach.
The Department received comments on this issue from a range of stakeholders, including individuals with disabilities, disability advocacy organizations, and health care providers. Many commenters supported the Department's proposal. In response to the Department's request for comments on the effectiveness of programs used to ensure that staff are qualified, several disability advocacy organizations noted that even when a health care provider has accessible MDE, staff are sometimes unable to operate it. Many people with disabilities and disability advocacy organizations also described interactions with staff who were not able to provide assistance with transfers or did not provide program access in other ways. These accounts supported the need for § 35.213, which explicitly requires public entities to ensure that their staff members are able to successfully operate accessible MDE, assist with transfers, and ensure program access.
A disability advocacy organization proposed that the Department revise the text of § 35.213 to include personnel who are responsible for scheduling appointments and maintaining accessible MDE, and to require public entities to ensure that staff members are able to maintain accessible MDE and ensure scheduling times and reservations appropriate for patients with disabilities. The Department believes that the current language of the general nondiscrimination obligation set forth in § 35.210 and the program access obligation set forth in § 35.212, in conjunction with the other provisions in the title II regulation that require equal access and maintenance of accessible features,[47] is sufficient to address the issues raised by the commenter. The Department also notes that § 35.213 pertains to public entities' staff but is not limited to particular types of staff. As with the other topics for training discussed in the section-by-section analysis of § 35.213, public entities may find that providing their staff with the training this commenter described is often the most effective way to meet their obligations under subpart I of this part and other parts of the ADA. The lack of a specific requirement to provide training to these personnel regarding these issues would not excuse a related ADA violation.
Only one commenter opposed § 35.213. This commenter stated that requiring public entities to ensure that their staff members are able to assist with transfers would lead to discrimination against employees with disabilities who are not physically able to assist with transfers. The Department notes that subpart I of this part does not supersede or alter title I of the ADA or occupational safety standards, or redefine the essential functions of any particular employee's job.[48] Qualified employees with disabilities remain entitled to reasonable accommodations as specified in existing law.[49] However, an individual employee's need for accommodations does not diminish the rights of other individuals with disabilities to have equal access to the services, programs, and activities provided by a public entity.
Many commenters encouraged the Department to establish more explicit and specific requirements for training. Commenters provided a variety of suggestions for what these requirements should be, including certification; training by the manufacturers of accessible MDE; periodic "refresher" training; and training on additional topics, such as the maintenance of accessible MDE, appointment scheduling and booking accessible MDE, attitudinal barriers, implicit bias, ableism, disability culture, disability history, providing care to individuals with disabilities, transfer support and practice, the use of lifts, plain language, effective communication, and reasonable modifications. One commenter suggested that the Department should withhold Federal funding if certain training is not conducted. Many commenters stated that people with disabilities should be involved in training so that public entities are able to draw from individuals' lived experiences.
In response to the Department's request for comments on the costs of programs for ensuring qualified staff, a few commenters stated that the cost of training would be minimal, especially in comparison to the cost of an injury to individuals with disabilities or personnel. These commenters stated that proper training reduces the number of injuries to individuals with disabilities and staff, ultimately reducing costs for covered entities.
After considering all of these comments, the Department declines to impose more specific requirements in § 35.213. Training, including training on the topics commenters suggested, will often be the most effective way to for public entities to ensure compliance with the entity's obligations under subpart I of this part. Training developed in consultation with, or provided by, individuals with disabilities may be particularly effective. And the Department appreciates commenters' views that training may ultimately reduce costs. However, the Department believes it is important to provide public entities with flexibility to determine how they will comply with the qualified staff requirement. Appropriate methods for meeting this requirement may differ for small health care providers as opposed to large hospital systems, for example. The Department has therefore decided not to mandate one specific process or curriculum that all public entities must follow to comply with § 35.213.
Several commenters suggested steps the Department could take to assist covered entities in complying with this requirement and the other requirements set forth in subpart I of this part. Suggestions included providing additional guidance, technical assistance, training, and financial resources. Some commenters also suggested that the Department collaborate with manufacturers to provide instructions on how to use accessible MDE or encourage covered entities to request instructions during procurement. The Department notes that it has already provided some technical assistance.[50] If public entities would find it helpful to seek additional information from MDE manufacturers or vendors, the Department encourages entities to do so. As noted in the discussion of § 35.211(c), the Department does not currently operate a grant program to assist public entities in complying with the ADA. The Department will, however, continue to consider what additional guidance, technical assistance, or training it can provide that will assist regulated entities in complying with their obligations under subpart I of this part.
Public Comments on Other Issues in Response to NPRM
The Department received comments on a variety of other issues in response to the NPRM. Several commenters recommended that the Department prescribe specific steps that all entities must take in order to carry out the primary requirements in subpart I of this part, such as employing scheduling and reservation systems; maintaining and publishing lists of accessible inventory, including the location of such equipment; reimbursing patients for transportation costs to accessible facilities; using certain staff-to-patient ratios; having staff take notes on each patient's needs and the patient's level of understanding; providing communication access in American Sign Language and Braille; using patient lifts or transfer teams; and offering scales and health monitoring tools for home use to patients with transportation difficulties. Another commenter suggested that entities subcontract with disability groups to test MDE that the entities have purchased. Some commenters also suggested that the Department issue guidance on various topics.
While the Department appreciates commenters' thoughtful suggestions, the Department declines to prescribe that public entities must take these specific steps in order to carry out the requirements in subpart I of this part. The Department intends to instead give public entities and members of the public clarity about the requirements in subpart I of this part, while also giving public entities flexibility in determining how best to carry out those requirements based on their individual circumstances. Public entities may find that many of the approaches recommended in the comments summarized in the preceding paragraph will enable them to carry out the requirements in subpart I of this part. The Department will also consider providing additional guidance to public entities about how to comply with subpart I of this part.
Commenters also expressed concern that people with disabilities are not involved in decisions associated with their care, in general. One commenter suggested that all policies about people with disabilities should be formed in consultation with an advisory council of people with a range of disabilities. The Department agrees that it is important to involve people with disabilities in decisions involving the creation and implementation of disability-related rules and policies. Indeed, the technical standards that the Department is adopting were created by the Access Board, a coordinating body that includes 13 members of the public, most of whom are required to have a disability in order to be appointed to the Access Board.[51] The Department has also carefully considered comments on the NPRM from many members of the public who self-identified as having a disability. In addition, individuals with disabilities can file a complaint with the Department or file a private lawsuit if a public entity fails to carry out its title II obligations. Given the existing mechanisms to solicit feedback and receive complaints about implementation from individuals with disabilities, the Department declines to create an advisory council in connection with this part.
The Department also received a comment suggesting that it regularly review and update accessibility standards to reflect technological advancements and the evolving needs of individuals with disabilities. Executive Order 13563 already requires the Department to review its regulations periodically to determine whether they should be modified, streamlined, expanded, or repealed.[52] Further, section 510 of the Rehabilitation Act requires the Access Board, in consultation with the Food and Drug Administration, to periodically review and, as appropriate, amend the MDE standards.[53] Therefore, a separate mechanism for reviewing the effectiveness of this part is not necessary.
Finally, the Department received a few comments asking that it make the MDE Standards enforceable against title III entities. As noted in section II.A of the preamble to the final rule ("Statutory and Rulemaking Overview"), the Department will continue to consider issues concerning MDE under title III. The Department will also continue to consider further rulemaking on this topic. However, title III entities are not the subjects of this rulemaking.
28 C.F.R. 35, app E to Part 35