On July 26, 2022, the U.S. Department of Health and Human Services (HHS) announced a proposed rule implementing revised regulations for Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, language, sex, age, and disability in health programs and activities. Section 1557 has the broadest coverage of any federal law governing health care civil rights, including being the first federal law in U.S. history to ban health care sex and gender discrimination.
The newly proposed regulations restore and strengthen civil rights protections for patients and consumers in federally funded health programs and activities, reversing the 2020 rules that limited Section 1557’s scope and coverage.
The Section 1557 Notice of Proposed Rulemaking (NPRM) seeks to address gaps identified in prior regulations and advance new protections, such as a banning the discriminatory use of clinical algorithms in health care decision-making. In sum, the NPRM:
- Reinstates the scope of Section 1557 to broadly cover HHS’ health programs and activities;
- Clarifies the application of Section 1557 nondiscrimination requirements to health insurance issuers that receive federal financial assistance;
- Aligns regulatory requirements with federal court decisions to prohibit discrimination on the basis of sexual orientation and gender identity;
- Makes clear that discrimination on the basis of sex includes discrimination on the basis of pregnancy or related conditions, including “pregnancy termination;”
- Ensures that requirements to prevent and combat discrimination are operationalized by entities receiving federal funding by requiring specific civil rights policies and procedures;
- Requires entities to give staff training on health care civil rights requirements, including but not limited to the provision of language assistance services for limited English proficient (LEP) individuals and effective communications for people with disabilities;
- In determining language assistance compliance, HHS will 1) evaluate, and give substantial weight to, the nature and importance of the health program or activity and the particular communication at issue to the LEP individual, and 2) take into account other relative factors such as the effectiveness of the covered entity’s written language access procedures;
- Prohibits reliance on a minor child to interpret or facilitate communication except in temporary or emergency situations;
- Prohibits the use of machine translations unless first reviewed by a qualified human translator when accuracy is essential or the source materials contain complex, non-literal, or technical language;
- Requires written language access procedures in HHS funded health programs and activities describing the process for providing language assistance services to limited English proficient individuals;
- Requires written effective communication procedures in HHS funded health programs and activities describing the covered entity’s process for ensuring effective communication for individuals with disabilities;
- Requires covered entities to provide notices of nondiscrimination and notices of the availability of free language assistance services and auxiliary aids and services;
- Requires federally subsidized health organizations employing fifteen or more persons to designate and authorize at least one employee, referred to as “Section 1557 Coordinator,” to coordinate the covered entity’s compliance with its responsibilities under Section 1557;
- For the first time, explicitly prohibits discrimination in the use of clinical algorithms to support decision-making in health care programs and activities;
- Clarifies for the first time that nondiscrimination requirements applicable to health programs and activities include those services offered via telehealth, which must be accessible to LEP individuals and individuals with disabilities;
- Interprets Medicare Part B for the first time as federal financial assistance, thus bringing providers who accept Medicare Part B reimbursement within the law’s requirements; and
- Refines and strengthens the process for raising conscience and religious freedom objections.
The NPRM is available at this link: https://www.federalregister.gov/public-inspection/2022-16217/nondiscrimination-in-health-programs-and-activities
Public comments to the NPRM must be filed with HHS no later than October 3, 2022.
© Bruce L. Adelson 2022. All Rights Reserved The material herein is educational and informational only. No legal advice is intended or conveyed.
Bruce L. Adelson, Esq., is nationally recognized for his compliance expertise. Mr. Adelson is a former U.S Department of Justice Civil Rights Division Senior Trial Attorney. Mr. Adelson is a faculty member at the Georgetown University School of Medicine and University of Pittsburgh School of Law where he teaches organizational culture, implicit bias, cultural and civil rights awareness.
Mr. Adelson’s blogs are a Bromberg exclusive