Proposed Section 1557 Rule – How Could It Affect You?

The U.S. Department of Health and Human Services (HHS) has proposed to strengthen the interpretation of the Section 1557 of the Affordable Care Act (ACA) last modified in 2020 (“2020 Rule”). In the proposed version of the rule, HHS argues Section 1557 should apply more broadly than the 2020 Rule did, which includes extending the definition of “covered entity” to any health program or activity accepting “federal financial assistance”, including those who provide, administer or assist persons with health-related services or insurances, and/or providing pharmaceutical, clinical or medical care.

HHS names several proposed revisions, including but not limited to:

  • Discrimination against Limited English Proficiency (LEP) individuals: the Section 1557 Notice of Proposed Rulemaking (NPRM) includes “requiring entities to give staff training on the provision of language assistance services for individuals with limited English proficiency (LEP), and effective communication and reasonable modifications to policies and procedures for people with disabilities.” Additionally, the proposed rule looks to reinstate a previous requirement from the 2016 version of the Final Rule that obligates covered entities from notifying patients of their ability to provide language assistance services.
  • Disability Discrimination: Barriers were observed when patients requiring screen reader software or those who require modifications to the usual “point-and-click” mouse attempted to sign-up for COVID-19 vaccinations and tests online. Therefore, the proposed rule calls for covered entities to make “reasonable modifications” to allow these individuals to access telehealth services in a nondiscriminatory manner and requires those entities to alert their patients of auxiliary aids and services available.
  • Section 1557 Policies & Procedures Program: Covered entities would be required to develop and implement a Section 1557 Policy, complete with a written Policy & Procedure manual. As part of the program, a covered entity is to have a nondiscrimination policy, procedures in place to mitigate any grievances that would arise, what language accommodations are available to individuals, etc. In addition, covered entities that employ a minimum of 15 employees would designate a “Section 1557 Coordinator” who will ensure entities are adhering to the goals set forth by Section 1557.
  • Section 1557 Training: Despite the 2016 and 2020 Rule not having a training requirement, HHS proposes that training should be done to best mitigate any potential Section 1557 violation. Although who does the training, the content, and the timing of the training is left up to the covered entity to determine, HHS proposed “relevant employees” complete training over the covered entity’s Section 1557 Policies and Procedures at a minimum. Training should be completed “within a reasonable period of time” after being hired and “within a reasonable time after a material change has been made”.

Currently, the Rule is in the Notice of Proposed Rulemaking (NPRM) stage and HHS is eliciting feedback until October 3, 2022. If you are interested in providing feedback, follow the link to the Federal Register. PAAS will be keeping abreast on what comes of the NPRM. In the meantime, it is becoming increasingly apparent that healthcare entities have a requirement to provide culturally competent care, free of discrimination. Consider investing in PAAS’ Cultural Competency Training, which has a section on LEP individuals and how to go about providing equal opportunities to healthcare recipients in your area.

Meredith Thiede, PharmD