• Final Rule on Section 1557 of the ACA Has Implications for Digital Health Industry
  • August 25, 2016 | Authors: Stephen E. (Steve) Gillette; Alexis S. Gilroy; Kevin D. Lyles; Cristiana Spontoni; Soleil E. Teubner
  • Law Firms: Jones Day - Palo Alto Office ; Jones Day - Washington Office ; Jones Day - Columbus Office ; Jones Day - Brussels Office ; Jones Day - San Francisco Office
  • On May 18, 2016, the Department of Health and Human Services ("HHS") issued a final rule implementing Section 1557 of the Patient Protection and Affordable Care Act ("ACA"), which prohibits discrimination on the grounds of race, color, national origin, sex, age, or disability in certain health programs and activities. Effective July 18, 2016, the final rule, "Nondiscrimination in Health Programs and Activities" ("Rule"), will require entities covered by the Rule to comply with certain accessibility requirements applicable to their use of technology in the provision of services.

    The Rule applies to: (i) to every health program or activity, any part of which receives federal financial assistance provided or made available by HHS; (ii) health insurance plans and marketplaces; and (iii) HHS itself. The Rule defines "HHS financial assistance" broadly, to include almost all types of financial benefit transfers, among them grants, loans, credits, subsidies, or transfers of real or personal property (but excludes Medicare Part B payments). Key points of the Rule include the following:

    First, the Rule requires entities covered by the Rule to make all programs and activities provided through electronic and information technology (e.g., a website) accessible for individuals with disabilities, unless doing so would impose undue financial or administrative burden. In addition, such entities must provide appropriate auxiliary aids and services when necessary to ensure an equal opportunity for persons with disabilities to participate in and benefit from the entity's health programs or activities. Auxiliary aids and services include qualified sign language interpreters, captioning, large print materials, screen reader software, text telephones, and video remote interpreting services, among other things. In short, entities covered by the Rule must take appropriate steps to ensure that communications with individual with disabilities are as effective as communications with others, in accordance with Title II of the Americans with Disabilities Act of 1990 and related regulations.

    Second, entities covered by the Rule must take reasonable steps to provide meaningful access to individuals with limited English proficiency eligible to be served or likely to be encountered in their health programs and activities. This includes providing language assistance services, such as oral language assistance or written translation, free of charge and in a timely manner.

    Third, entities covered by the Rule must comply with certain procedural requirements. Specifically, the Rule requires applicable entities with 15 or more employees to have a grievance procedure, to identify at least one individual accountable for coordinating the regulated entity's compliance, and to have a written process in place for handling grievances.

     In addition, entities covered by the Rule that operate websites must post on the website notices of nondiscrimination and taglines that alert individuals with limited English proficiency to the availability of language assistance services. Such taglines must be posted in at least the top 15 non-English languages spoken in the state in which the entity is located or does business.

    For health care providers operating in the digital health industry as well as for software and other technology vendors working with health care providers, the Rule may create a number of new challenges. Website accessibility has likewise been the focus of increasing litigation activity, and a number of high-profile settlements have emphasized the potential risks entities may face by failing to address technology-based accessibility issues. Providers would be well advised to review their websites and other customer-facing technology with counsel to determine the applicability of the Rule to their activities, as well as any broader accessibility considerations and exposure.