September 29, 2022
Melanie Fontes Rainer Acting Director
US Department of Health & Human Services, Office for Civil Rights Attention: 1557 NPRM (RIN 0945–AA17)
Hubert H. Humphrey Building, Room 509F 200 Independence Avenue SW Washington, DC 20201
RE: Docket ID: HHS–OS–2022–0012 RIN: 0945–AA17
Nondiscrimination in Health Programs and Activities
Dear Ms. Fontes Rainer:
This letter outlines the response of the National Federation of the Blind, the nation’s transformative organization of the blind, to the Notice of Proposed Rulemaking published on August 4, 2022, introducing revisions to Section 1557 of the Affordable Care Act (Section 1557). We thank the US Department of Health & Human Services, Office for Civil Rights (HHS OCR) for seeking public feedback on this rulemaking. Specifically, we applaud HHS OCR’s efforts to clarify and expand protections for individuals with disabilities and other protected classes. We support the proposed rule generally but urge inclusion of the following critical items.
Definitions
We urge the Department to add the following definitions to Section 92.4:
Accessible.—The term “accessible” or “accessibility,” used with respect to Information and Communication Technology (ICT), means perceivable, operable, understandable, and robust ICT that enable persons with disabilities to access the same information as, to engage in the same interactions as, to communicate and to be understood as effectively as, and to enjoy the same services offered to other persons with the same privacy, same independence, and same ease of use as, nondisabled persons.
At-Home Test.—the term “at-home test” means any test intended for users in any environment outside of a professional healthcare facility. This includes tests intended for use in both professional healthcare facilities and homes.
Digital Interface.—The term ‘digital interface’ means a means by which human users interact or communicate with electronic devices, including computerized devices.Home Use Device—the term “home use device” means a medical device intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes.1
Accessibility Standard
Regarding adopting a specific accessibility standard, we urge HHS OCR to adopt the definition of accessibility proposed above, and we support the reference to Web Content Accessibility Guidelines (WCAG) 2.1AA as an accepted measure of accessibility.
Telehealth
We approve proposed Section 92.211 clarifying that a covered entity must not, in delivery of its health programs and activities through telehealth services, discriminate on the basis of race, color, national origin, sex, age, or disability. Covered entities must ensure that telehealth services are accessible to individuals with disabilities by guaranteeing conformance with the definition of Accessibility proposed in these comments. All aspects of covered entities’ telehealth services, including videoconferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications and any ancillary services, such as the process for scheduling telehealth appointments, must be compatible with screen access software and independently usable by blind people, so that blind people are not forced to rely on others to help them access telehealth services or forgo these important services. Too often blind patients are not afforded equal access to this critical service. Such was the experience of National Federation of the Blind member Anil Lewis, who earlier this year twice attempted to engage in telehealth appointments via the PROCLE telehealth platform. On his first attempt, Mr. Lewis entered the required information, was told to select various buttons, and then was told he was in the queue and connected. However, Mr. Lewis was not connected to his appointment; it took forty minutes of frustrating attempts to make the platform work due to mislabeled links/buttons and other inaccessible controls, resulting in an appointment that was much shorter than it should have been. On his second attempt, Mr. Lewis was unable and unwilling to go through the process of trial and error to connect to the PROCLE telehealth platform using his nonvisual screen access software, forcing his doctor to call him by phone for the appointment, and sacrificing the visual feedback and other features available via this telehealth platform.
At-Home Tests
We urge the Department to include a new subsection in Subpart C—Specific Applications to Health Programs and Activities, entitled Nondiscrimination in the provision and use of at-home tests and to include that a covered entity must not, in delivery of its health programs and activities through the use of at-home tests, discriminate on the basis of race, color, national origin, sex, age, or disability. At-home tests must be equally accessible for disabled individuals. For example, if sighted individuals can collect their own sample, perform the test, and read the results at-home, with or without the use of technology such as a smartphone, then the test must be equally usable by blind individuals.
We understand that developing and manufacturing accessible tests may take time and urge HHS OCR to include a timeline of three years for such at-home tests to conform with this requirement. In the interim, we urge HHS OCR to adopt a temporary rule that, in the event that both an accessible and inaccessible version of an at-home test exists, a covered entity must provide the accessible version to blind patients at the same level of coverage as the inaccessible one.
The COVID-19 pandemic has amplified Americans’ reliance on virtual and at-home tools and services. Blind individuals who, because of accessibility barriers, could not use the at-home COVID-19 test kits they received through the federal or state governments or purchased over the counter were forced to rely on the help of a sighted individual to complete their test or forgo completing the test and knowing whether they had contracted COVID-19. In one example, earlier this year, National Federation of the Blind member Barbara Loos received an inaccessible Abbott Binax test from the Nebraska Health Department. When the online proctor she engaged through Abbott’s NAVICA system disconnected their chat after Ms. Loos explained that she was blind and that she did not have sighted in-home assistance to help her correctly place the solution drops on her test card, she understood that her state’s health department and Abbott had failed to consider how blind people can access at-home COVID tests.2
Accessible Medical Diagnostic Equipment
Regarding how best to address challenges accessing accessible medical diagnostic equipment and whether lack of access to such equipment constitutes discriminatory benefit design or network inadequacy, we urge HHS OCR and other federal agencies to establish nonvisual accessibility standards for certain devices. Specifically, we urge that the rule include that medical devices classified under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) must incorporate a digital interface that allows for blind or low-vision individuals to access the same information as, to engage in the same interactions as, to communicate and to be understood as effectively as, and to enjoy the same services offered to other persons with the same privacy, same independence, and same ease of use as, nondisabled persons. We understand that developing and manufacturing these devices may take time and urge HHS OCR to include a timeline of three years for such medical diagnostic equipment to conform with this requirement. In the interim, we urge HHS OCR to adopt a temporary rule requiring that, in the event that both an accessible and inaccessible version of medical device exists, a covered entity must provide the accessible version to blind patients at the same coverage level as the inaccessible one.
Indeed, lives depend on HHS OCR’s rules. Historically, covered entities, have not provided this level of equal access. In 2017, CMS made a dangerous policy decision to not reimburse Medicare beneficiaries for continuous glucose monitors when they were used in conjunction with a mobile app, rendering nonvisual accessibility features unattainable to blind diabetics.3 In response to advocacy by the National Federation of the Blind, this decision was reversed, but still only covers equipment currently manufactured. This lack of accessible medical devices isn’t limited to those that are used to manage diabetes. Home-use devices, such as those that deliver chemotherapy or dialysis continue to be produced with updated technology but without accessibility, and manufacturers and providers are not currently being held accountable.4 As described in the Medical Device Nonvisual Accessibility Act (H.R. 4853), introduced during the 117th Congress,
“Rapid advances in digital technology have led to increasingly complex user interfaces for everyday products, such as life-sustaining medical devices and technologies. Many of these new devices utilize displays that can only be operated visually and require user interaction with on-screen menus and other interfaces that are inaccessible to consumers who are blind or have low-vision. Medical devices designed for use in the home are being increasingly utilized to lessen the cost of inpatient care for consumers. Devices such as blood pressure monitors, sleep apnea machines, and in-home chemotherapy treatments generally lack nonvisual accessibility. . . Devices can be designed to work with nonvisual access technology used by individuals who are blind or have low-vision at little or no extra cost as long as such compatibility is taken into consideration at the beginning of the design process. Consumers who are blind or have low-vision must be able to operate medical devices in an equally effective and equally integrated manner and with equivalent ease of use as consumers without disabilities.”5
Undue Financial and Administrative Burdens or Fundamental Alteration
Though federal disability rights law already requires auxiliary aids and services to “be provided in accessible formats, in a timely manner, and in such a way as to protect the privacy and independence of the individual with a disability” (28 C.F.R. § 36.303), we request that HHS OCR clarify and incorporate into its rulemaking in Section 92.202 effective communication for individuals with disabilities that covered entities must ensure that the auxiliary aids and services they provide offer full privacy and independence in conjunction with access. In situations where an entity asserts that providing an auxiliary aid would constitute an undue burden or fundamental alteration, it must still afford the consumer with disability full privacy in whatever alternative is offered. Though federal law is clear, agencies have not provided this same level of privacy to disabled consumers as to sighted consumers. Lawsuits regarding inaccessible intake processing kiosks provide a clear example of how, too often, the solution offered is to have a security guard or attendant verbally accept private personal and health information from the blind consumer, frequently in a waiting room with other patients, to then enter manually into the inaccessible kiosk. Names, birthdates, insurance information, health diagnoses and maladies, and much more are shared in this manner.6
Kiosks
We applaud HHS OCR including kiosks, specifically, as an example within the description of Information and Communication Technology (ICT) in Section 92.204. As referenced in the US Department of Justice’s Statement of Interest in Vargas, et al v. Quest Diagnostics, health care providers continue to implement self-service kiosks for a variety of functions, including patient check-in, gathering health and insurance information, processing fees, and other functions.7
As referenced previously, though federal law requires that covered entities must ensure that the auxiliary aids and services they provide allow for full privacy and independence, many kiosks remain inaccessible and covered entities too often require a blind patient to verbally share private information that sighted patients easily enter into an intake processing kiosk. Lawsuits specific to this space, and their resulting settlement agreements, have provided an outline for how covered entities can and should ensure kiosk accessibility.8 We urge HHS OCR to make available to covered entities best practices specific to visitor intake processing kiosk accessibility.
Integration Mandate and Medicare Part B Coverage
We approve incorporating the integration provision at 45 CFR 84.4(b)(2) into Section 1557 at proposed Section 92.101(b)(1) and Medicare Part B Coverage as federal financial assistance in Subpart A—General Provisions. Insurance or plan benefits that result in segregation or institutionalization of individuals with disabilities or place them at serious risk of institutionalization or segregation include those that deny or limit coverage for accessible medical diagnostic equipment and home-use devices that would allow a blind individual to administer their own care or recover in the safety of their home and community, as opposed to isolated within an institution. Similarly, covered entities that do not provide effective communication limit a blind individual’s ability to remain independent and integrated within his or her community; the lack of accessible post-operation instructions, for example, can limit a blind individual’s ability to safely return home and can prompt extended and isolating stays in recovery units.
Effective Communication
Regarding steps the Department can take to assist covered entities in meeting their effective communication responsibilities, such that these services are provided in the most efficient and effective manner for participants, beneficiaries, enrollees, and applicants of covered health programs and activities, HHS OCR can offer template policies, procedures, and trainings for covered entities to implement. We urge specific focus on the Americans with Disabilities Act “primary consideration” requirement and limited applicability of undue burden and fundamental alteration defenses. Institutions such as the University of Delaware have developed guidance for effective communication for care providers caring for people with disabilities. Settlement agreements, such as in Figueroa, et al v. Azar9 provide a template and best practices. These existing resources can be used to create an HHS OCR-sponsored template.
Template policies, procedures, and trainings must include that the communication covered is not limited to what occurs within a hospital, doctor’s office, or telehealth portal; it should include and not be limited to notices, correspondence, forms, questionnaires, visit summaries, follow-up instructions, and billing information. Template training material must include the risks—incomplete and inaccurate medical information and diagnoses—that are introduced when communication is not provided accessibly and effectively. Similarly, template training material must include the direct impact on individuals with disabilities, such as those evidenced in Bone, et al v. University of North Carolina Health Care System and Nash Health Care Systems, inaccessible communication with blind patients:
“compromises their ability to review and, if necessary, respond to communications on a timely basis, and forces them to rely on and divulge private medical and financial information to sighted third parties for assistance. This disrupts blind patients’ access to their health care, prevents them from understanding and following medical instructions, and results in unfair financial penalties for not being able to access and pay medical bills on time, all leading to significant financial and personal hardship. For the communications to be effective, auxiliary aids and services must be provided in accessible formats, in a timely manner, and in such a way as to protect the privacy and independence of the individual with a disability. 28 C.F.R. § 35.160.”
Electronic Health Records
We urge the Department to include “electronic health records (EHRs)” as an example within the definition of “information and communication technology (ICT).” We further urge the Department to include in Section 92.204 Accessibility of information and communication technology for individuals with disabilities that covered entities must not discriminate against their qualified employees with disabilities by developing, providing, implementing, and maintaining inaccessible ICT, including electronic health record systems. Lawsuits including Drake v. Univ. of Texas Physicians and National Federation of the Blind v. Epic Systems Corporation describe the significant barriers that blind employees in the healthcare field encounter when entities implement inaccessible EHR systems. Blind employees Suzanne Drake and Manuel Morse were both unable to perform critical functions of their jobs and both placed on mandatory leave by their employers, in Ms. Drake’s case mandatory unpaid leave, because the electronic health record systems implemented were inaccessible and incompatible with the screen access software Ms. Drake and Mr. Morse use to access information.
Safe Harbor
We are opposed to including a safe harbor for covered entities that comply with the yet to be determined Section 1557 accessibility standard and are especially opposed to a safe harbor that perceives conformance with Title II of the ADA. The ADA, Rehabilitation Act, and other federal laws must continue to provide standalone protections.
Timeline for Adoption
Regarding including a timeline for adoption, we recommend that the entities be provided three years from the enactment of the rulemaking to be in compliance with all sections.
In conclusion, we again thank HHS OCR for the opportunity to comment on the critical importance of accessibility and nondiscrimination regulations implementing the Affordable Care Act. The National Federation of the Blind is available to provide clarification on our comments and is available as a resource during the rulemaking process. Please do not hesitate to contact me at 410-659-9314.
Sincerely,
Mark A. Riccobono, President National Federation of the Blind
Footnotes:
1 US Food and Drug Administration, “Home Use Devices,” August 31, 2018, https://www.fda.gov/medical- devices/home-health-and-consumer-devices/home-use-devices.
2 Valerie Yingling, “The Quest for a Covid-19 Test,” Braille Monitor, May 2022, https://nfb.org//images/nfb/publications/bm/bm22/bm2205/bm220507.htm.
3 National Federation of the Blind, “Advocacy Win for the Blind Diabetic Community,” Voice of the Nation’s Blind Blog, June 27, 2018, https://nfb.org/blog/advocacy-win-blind-diabetic-community.
4 Danielle McCann, “Living with Diabetes as a Blind Person,” Voice of the Nation’s Blind Blog, June 7, 2022, https://nfb.org/blog/living-diabetes-blind-person.
5 Medical Device Nonvisual Accessibility Act, H.R. 4853, 117th Congress, https://www.congress.gov/bill/117th- congress/house- bill/4853/text?q=%7B%22search%22%3A%5B%22H.R.+4853%22%2C%22H.R.%22%2C%224853%22%5D%7D&r=
3&s=1.
6 See https://www.ada.gov/quest_soi.pdf. See also Irving, et al v. Saul.
7 https://www.ada.gov/quest_soi.pdf. See also, as cited by the US Department of Justice, Glenda Wrenn et al., Using a self-service kiosk to identify behavioral health needs in a primary care clinic serving an urban, underserved population, 22 J. I NNOVATION IN HEALTH I NFORMATICS 3, 323 (2015),
https://informatics.bmj.com/content/bmjhci/22/3/323.full.pdf; FRANK MAYER, Healthcare Kiosks, https://www.frankmayer.com/industries/healthcare/.
9 https://nfb.org/images/nfb/documents/pdf/legal_program/settlements/cms_agreement_with_addendums.pdf.