New Section 1557 anti-discrimination final rule addresses telehealth requirements

The US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the Centers for Medicare and Medicaid Services (CMS) have jointly released a comprehensive Final Rule updating the non-discrimination regulations (45 CFR Part 92) under Section 1557 (42 U.S.C. § 18116) of the Patient Protection and Affordable Care Act (PPACA) to provide greater protections to patients against discrimination in health care on the basis of race, color, national origin, sex, age, or disability.

As described in our previous alerts (here and here), the Final Rule has far-reaching impacts for companies in the healthcare industry. For the first time, it expanded the categories of federal financial assistance, triggering federal civil rights laws to include any provider or supplier that receives Medicare payments.

While the changes will likely have a significant impact on a broad range of companies operating in the healthcare industry, telehealth providers are encouraged to become familiar with the requirements under the Final Rule, as well as the OCR and CMS position, that Section 504, title VI, and Section 1557, imposed many of these obligations on telehealth service providers prior to the Final Rule.

When are the Final Rule’s provisions on telehealth effective?

The Final Rule’s provisions with respect to telehealth will be effective 60 days after publication. Publication is targeted for May 6, 2024, making it effective July 5, 2024. Therefore, telehealth service providers that receive Medicare payments are advised to evaluate their programs to ensure that they make available reasonable mitigations and accessibility tools to patients prior to July, which notably includes those individuals with disabilities and individuals with limited English proficiency (LEP), and appropriately notify patients of the availability of such tools in accordance with 42 C.F.R. § 92.11.

Considerations for telehealth providers

The Final Rule implements 42 C.F.R. § 92.211, titled “Nondiscrimination in the delivery of health programs and activities through telehealth services,” which prohibits covered entities from, in delivery of their health programs and activities through telehealth services, discriminating on the basis of race, color, national origin, sex, age, or disability. In accordance with the rule, telehealth platforms must be accessible to individuals with disabilities, unless doing so would impose undue financial and administrative burdens, or would result in a fundamental alteration in the nature of a covered entity’s health programs or activities.

Specifically, OCR notes that communications before, during, and after telehealth appointments must be accessible to individuals with disabilities and individuals with LEP. Further, companions with disabilities and companions with LEP also require effective communications and meaningful access under the Final Rule. OCR also referenced its joint guidance with the Department of Justice (DOJ) on non-discrimination in telehealth, and specifically noted covered entities’ responsibilities to ensure effective communication and the provision of auxiliary aids and services, as well as the provision of language assistance services for individuals with LEP.

While OCR declined to implement a requirement that telehealth providers offer in-person care, it noted that in-person alternatives to telehealth may, in certain situations, be needed to ensure effective communication for individuals with disabilities or LEP. Similarly, OCR noted that telehealth services might also constitute a reasonable accommodation for in-person facilities, particularly for individuals with contagious diseases or mobility challenges.

Further, while OCR concluded that covered entities should be allowed flexibility in determining whether to assess individuals with disabilities seeking to use telehealth platforms, including visual, cognitive, intellectual, mobility, and functional needs, that such assessments were recommended as a best practice. OCR expressly stated that it was not adopting an assessment requirement at this time, but it would continue to monitor developments in this area.

OCR is seeking comment on this approach, and whether covered entities and others would benefit from a specific provision addressing accessibility in telehealth services for individuals with disabilities and individuals with LEP. Notably, OCR also declined adopting specific accessibility standards for telehealth platforms, both due to the rapid evolution of telehealth platforms and technology and because of ongoing rulemakings in the field by both OCR and DOJ.

The Final Rule’s definition of telehealth

The Final Rule also included a definition of “telehealth” under § 92.4 consistent with the Health Resources and Services Administration and the Office of the National Coordinator for Health Information Technology definitions referenced in the 2022 Notice of Proposed Rulemaking, 87 FR 47884. As defined, telehealth means “the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health, and health administration.”

OCR further noted that telehealth technologies include “videoconferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications” as well as audio-only and remote patient monitoring services. Medical devices, tests, and equipment that are used as part of a health program or activity delivered through telehealth services are also subject to the accessibility standards.

The Final Rule and ICT

The standards set forth in the Final Rule are closely related to the standards regarding information and communication technology (ICT) for individuals with disabilities; however, OCR explained how the two requirements interact.

By way of background, ICT relates to the technology and other equipment the means by which facilitate access to information in a health program or activity. ICT includes, but is not limited to, computers and peripheral equipment; information kiosks and transaction machines; telecommunications equipment; telehealth interfaces or applications; customer premises equipment; multifunction office machines; software; mobile applications; websites; videos; and electronic documents. As defined above, telehealth is the medium through which a health program or activity is delivered and where individuals need appropriate access.

Accordingly, OCR explained that while telehealth interfaces and applications are a form of ICT, given the rapid expansion of telehealth by providers and broad impact telehealth has on the overall health care landscape, OCR wanted a specific telehealth section to ensure that health programs and activities delivered via telehealth technologies are done so without any discrimination.

OCR’s enforcement over Section 1557

Under the Final Rule, to the extent a covered entity’s telehealth policies or practices delay or deny an individual’s access to a health program or activity delivered via telehealth, OCR will consider whether the delay or denial is based on prohibited grounds under Section 1557 as set forth in this rule, including as a discriminatory benefit design prohibited under § 92.207(b)(2).

OCR has been granted enforcement authority over Section 1557, including the authority to handle complaints, initiate and conduct compliance reviews, conduct investigations, supervise and coordinate compliance within HHS, make enforcement referrals to the DOJ, in coordination with the HHS Office of the General Counsel and the relevant component or components of HHS, and take other appropriate remedial action as deemed necessary, in coordination with the relevant component or components of HHS, and as allowed by law. Prior to taking an enforcement action (such as terminating Federal financial assistance or referring the matter to DOJ for enforcement), OCR noted that it would work with covered entities to encourage voluntarily compliance, including through the provision of technical assistance or updates to policies and procedures.

However, Section 1557 does not remove or replace any enforcement mechanisms under Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.), Title IX of the Education Amendments of 1972 (20 U.S.C. 1681 et seq.), the Age Discrimination Act of 1975 (42 U.S.C. 6101 et seq.), or Section 504 of the Rehabilitation Act of 1973, including any private right of action under any of the foregoing.

It remains to be seen how these Section 1557 telehealth rules will ultimately be enforced as well as through any private right of action. It is notable, however, that there has been a dramatic increase in class action lawsuits alleging that websites and mobile applications violate the digital accessibility requirements under the Americans with Disabilities Act.

For any questions regarding the impact of the Final Rule on telehealth services and arrangements, please contact any of the authors of this alert or reach out to your DLA Piper relationship partner for more information.