1 Specifically, Section 4203 of the Patient Protection and Affordable Care Act amended Title V of the Rehabilitation Act by adding Section 510. See Patient Protection and Affordable Care Act § 4203, Pub. L. 111-148, 124 Stat. 570 (2010) (codified at 29 U.S.C. § 794f).

2 29 U.S.C. § 794f. Section 510 also directed the Access Board to promulgate these technical criteria within two years of the statutory effective date (i.e., March 2012). As noted in Section 3 below (Regulatory History), while the Access Board issued proposed rules by this deadline, various considerations (e.g., the technical nature of these standards, required consultations with the Food and Drug Administration and other federal agencies, and the need to seek expert assistance from an Advisory Committee) precluded issuance of a final rule within this statutory timeframe. The instant final rulemaking now completes the Access Board’s initial regulatory responsibilities under Section 510. Future rulemakings may update or revise the MDE Standards to, for example, incorporate technological changes or better address the access needs of particular beneficiary populations.

3 U.S. Access Board, Notice of Proposed Rule: Medical Diagnostic Equipment Accessibility Standards (NPRM), 77 FR 6915 (Feb. 9, 2012). In support of the proposed standards, the Access Board also provided a Preliminary RA discussing the need for rulemaking and presenting product and unit cost information concerning examination tables and weight scales. See US Access Board, Preliminary Regulatory Assessment for Medical Diagnostic Equipment Standards (Jan. 30, 2012). The Preliminary RA, along with other agency documents that serve as part of the MDE rulemaking record, are posted on the Access Board’s website (access-board.gov).

4 Ibid. at 6917 – 19.

5 See, e.g., Ibid. at 6919 – 32.

6 See US Access Board, Notice of Establishment; Appointment of Members - Medical Diagnostic Equipment
Accessibility Standards Advisory Committee, 77 Fed. Reg. 39,656 (July 5, 2012); see also NPRM, 77 Fed. Reg. at 6916 (noting intent to establish MDE Advisory Committee).

7 The MDE Advisory Committee had members representing the following organizations: The ADA National Network, Boston Center for Independent Living, Brewer Company, Conference of Radiation Control Program Directors, Inc., Duke University and Medical Center, Equal Rights Center, Evan Terry Associates, P.C., GE Healthcare, Harris Family Center for Disability and Health Policy at Western University of Health Sciences, Hausmann Industries, Inc., Hill-Rom Company, Inc., Hologic, Inc., Medical Positioning, Inc., Medical Technology Industries, Inc., Midmark Corporation, National Council on Independent Living, Paralyzed Veterans of America, Phillips Healthcare, Scale-Tronix, Inc., Siemens Medical Solutions USA, Inc., Stryker Medical, Sutter Health, United Spinal Association, and University of the Sciences in Philadelphia, Department of Occupational Therapy.

8 Nancy R. Mudrick et al., “Physical accessibility in primary health care settings: Results from California on-site reviews,” Disability and Health Journal 5 (2012): 159-167.

9 Comment of Midmark, Notice of Proposed Rulemaking for Medical Diagnostic Equipment (June 13, 2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0061.

10 Jill M. Winter et al., “Results of a National Survey on Accessibility of Medical Instrumentation for Consumers,” in Medical Instrumentation Accessibility and Usability Considerations, eds. Jill M. Winters and Mary Follette Story (New York: CRC Press, 2006), 13.

11 The study also reported the four categories of medical devices that were ranked as most difficult to use or access by type of disability. For respondents with visual impairments, the four most difficult categories to use (in rank order) were examination tables, weight scales, radiology equipment, and exercise and rehabilitation equipment; for respondents with hearing impairments, the top four were radiology equipment, exam tables, communication aids, and dental equipment; for respondents with speech impairments, the top four were radiology equipment, exam tables, exam chairs, and communication aids; for respondents with mobility impairments, the top four were exam tables, radiology equipment, exercise and rehabilitation equipment, and exam chairs; and for respondents with cardiopulmonary impairments, the top four were exam tables, radiology equipment, exercise and rehabilitation equipment, and exam chairs.

12 Mary Follette Story, Erin Schwier, and June Isaacson, “Perspectives of patients with disabilities on accessibility of medical equipment, medical chairs, and weight scales,” Disability and Health Journal 2 (2009): 169-179.

13 National Council on Disability, The Current State of Health Care for People with Disabilities (Washington, DC: National Council on Disability, 2009).

14 Harris Family Center for Disability and Health Policy, Importance of Accessible Examination Tables, Chairs and Weight Scales (Pomona, CA: Harris Family Center for Disability and Health Policy, 2010), accessed August 31, 2016. http://webhost.westernu.edu/hfcdhp/wp-content/uploads/1-Brief-Tables-Scales.pdf

15 See Comment of Midmark, Notice of Proposed Rulemaking for Medical Diagnostic Equipment, (June 13, 2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0061 (estimating that approximately 70% of all exam rooms in the United States have a manual exam table).

16 Complaint at 4-5, Meltzer et al. v. Kaiser Foundation Health Plan, Inc. et al., No. 829265-2 (Super. Ct. Alameda settled Apr. 12, 2001).

17 Mary Follette Story, Erin Schwier, and June Isaacson, “Perspectives of patients,” 176.

18 Complaint at 5, Meltzer et al.

19 Mary Follette Story, Erin Schwier, and June Isaacson, “Perspectives of patients,” 173.

20 Ana Todd and Alexa Stuifbergen, “Breast Cancer Screening and Disability,” Rehabilitation Nursing 37 (2012): 74-79 (discussing research indicating that women with major mobility impairments are substantially less likely to report having had a mammogram in the previous two years than women without such impairments).

21 United States Census, Americans with Disabilities: 2010 (2012), accessed on August 31, 2016. http://www.census.gov/prod/2012pubs/p70-131.pdf

22 United States Census, American Community Survey Sex by Age by Disability Status (2014), accessed August 31, 2016. http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ACS_14_5YR_B18101&prodType=table

23 Administration on Aging, A Profile of Older Americans: 2014 (Washington, DC: AOA, 2014), accessed on August 31, 2016. http://www.aoa.acl.gov/aging_statistics/profile/2014/docs/2014-profile.pdf

24 MDE Advisory Committee, Advancing Equal Access to Diagnostic Services: Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities (December 13, 2013), accessed August 31, 2016. https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report

25 See e.g. Settlement Agreement, Disability Rights Council el at. v. Washington Hospital Center, No. 1:03CV02434 (D.D.C. 2005).

26 U.S. Dept. of Justice and U.S. Dept. of Health and Human Services, Access to Medical Care for Individuals with Mobility Disabilities (July 2010), accessed on August 31, 2016. http://www.ada.gov/medcare_ta.htm.

27 U.S. Dept. of Justice, Advance Notice of Proposed Rulemaking: Nondiscrimination on the Basis of Disability by State and Local Governments and Places of Public Accommodation; Equipment and Furniture, 75 FR 43452 (July 26, 2010).

28 The Board selected several manufacturers in each category whose products appear frequently for sale in its internet search of online websites and catalogs. With respect to imaging equipment, the Board reviewed products made by well-known manufacturers, products frequently for sale on the secondary market, and, in a few cases, products noted in online articles or settlement documents as having features that made the equipment more accessible.

29 Head and back support is also required if the table reclines (M301.3.3), and where stirrups are provided, the equipment must meet leg support requirements (M301.3.2).

30 The adjustability requirement of M301.2.1 states that in addition to a low and high transfer height, equipment should have at least four intermediate transfer positions, separated by one-inch increments. While manufacturers typically provide a low and high height in the specifications for examination tables, the Board did not observe information on intermediate transfer heights. We were thus unable to ascertain from publicly available sources whether examination tables with intermediate transfer heights are commonly available in the market.

31 The wide variation in product specifications and combinations of features available in any given product model, coupled with a lack of publicly-available feature-by-feature price information for MDE products, has precluded the Access Board, in this Final RA, from assessing incremental unit costs for “accessible” components or products. Publicly available information does not typically provide a breakdown of product price by individual features. Further, in some cases, an accessible component is the absence of obstructions, which is difficult to evaluate from written product materials. It also bears noting that despite requests for public comment on MDE price/cost information, we received very little cost or price information from MDE manufacturers, health care providers, or other commenters, in response to the MDE NPRM. The Access Board did receive information one cost-related item concerning accessible examination tables from the MDE Advisory Committee. In one of the minority reports to the MDE Advisory Committee Report, four manufacturers of examination tables asserted that commercially available examination tables with a conforming low minimum height of 19-inches would be 24% more expensive it they also included leg and transfer supports that complied with the then-proposed MDE Standards. See Recommendation of 19-inch Lower Adjustable Height as the Minimum Accessibility Standard (Joint Report of The Brewer Company, Hausmann Industries, Medical Technology Industries, Inc., and Midmark Corporation) (Sept. 27, 2013), available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. However, this one cost-related item was insufficient, standing alone to assess incremental unit costs for accessible examination tables, let alone unit costs for accessible features on all types of medical diagnostic equipment.

32 Comment of Midmark, Notice of Proposed Rulemaking for Medical Diagnostic Equipment (June 13, 2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0061.

33 M302.2 also requires four intermediate transfer heights at one-inch minimum increments. As with examination tables, manufacturers typically do not indicate in their product specifications whether an examination chair has intermediate incremental heights between the high and low height for the chair. A chair that is continuously adjustable between the high and low heights via a power motor would likely meet the intermediate incremental heights requirement; however, since information regarding intermediate heights is not typically provided online for most models, the Board cannot conclude whether chairs with intermediate incremental transfer heights are commonly available in the market.

34 A limited number of wheelchair scales have two separate rails or spaces for wheels instead of a flat platform. We did not review these models.

35 See Comment of MITA, Notice of Proposed Rulemaking for Medical Diagnostic Equipment, (June 12, 2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0050.

36 Ibid.

37 See e.g., Testimony of Glenn Nygard, Holigic Corporation, U.S. Access Board Public Hearing (May 8, 2012). 

38 Depending on the image sought by a care provider, some patients might be instructed to remain in a seated position atop an x-ray table. Thus, theoretically an accessible x-ray table must also meet the requirements of M302 for diagnostic equipment used in a seated position. However, because the requirements of M302 are less restrictive than those of M301 for diagnostic equipment used a supine, prone, or side-lying position, equipment meeting the requirements of M301 necessarily also meets the requirements of M302.

39 The Board included in its review one model of mammography machine that has been discontinued, but is referenced in a DOJ settlement agreement as a wheelchair accessible model. We reviewed secondary sources regarding that particular model. Discontinued imaging equipment is relevant because of the robust secondary market for imaging equipment. See Testimony of Tony Roder, Regulatory Affairs Director for GE Healthcare, U.S. Access Board Public Hearing in Atlanta (May 8, 2012) (indicating that when top tier medical facilities upgrade their imaging equipment, they sell their old imaging systems on the secondary market to the next tier down of hospitals).