Section 1557 of the Affordable Care Act prohibits discrimination in healthcare based on a number of characteristics including race, color, national origin, sex, age, and disability. On April 26, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that according to HHS provides clarity on Section 1557 with a goal of ensuring nondiscriminatory access to care for all, including women, people with disabilities, LGBTQI+ people, people with limited English proficiency (LEP), people of color, and people regardless of age. The first Section 1557 final rule was published in 2016 followed by a second final rule in 2020 that rescinded large sections of the 2016 rule. The 2024 Final Rule restores those provisions and enhances them.

At the outset, the 2024 Final Rule reinstates application of Section 1557 to all HHS health programs and activities and state and federally facilitated exchanges. The 2020 rule narrowed the reach by applying only to specific programs and activities that receive federal funding and eliminated application to all HHS-administered programs. The 2024 Rule expands the application to include, for example, programs administered by the Indian Health Service, Centers for Medicare & Medicaid Services, and the National Institutes of Health and brings health insurers back within the purview of Section 1557.

The 2016 Final Rule defined discrimination “on the basis of sex” to include “pregnancy, false pregnancy, termination of pregnancy, or recovery therefrom, childbirth or related medical conditions, sex stereotyping, and gender identity,” whereas the 2020 Rule limited sex discrimination to the gender assigned at birth. Following the 2020 Final Rule, the U.S. Supreme Court held in Bostock v. Clayton County, Georgia (2020) 140 S.Ct. 1731 that an employer who fires an individual merely for being gay or transgender violates Title VII for engaging in sex discrimination because “it is impossible to discriminate against a person for being homosexual or transgender without discriminating against that individual based on sex.” The 2024 Final Rule affirms that sex discrimination includes discrimination based on sexual orientation and gender identity consistent with the Bostock decision.

Other key provisions of the 2024 Final Rule include:

  • Covered entities must not discriminate against any individual through the use of patient care decision support tools, and Covered entities must take reasonable steps to mitigate discrimination once made aware of the potential for discrimination resulting from use of these tools.
  • Covered entities must not discriminate in their delivery of health services provided through telehealth. This includes ensuring that such services are accessible to individuals with disabilities and LEP.
  • Covered entities must provide notice in prominent locations that language assistance services and auxiliary aids are available.
  • Sex discrimination includes discrimination on the basis of sex stereotypes; sex characteristics, including intersex traits; and pregnancy or related conditions; sexual orientation; and gender identity.
  • Covered entities must implement policies and procedures to ensure compliance with the rule. 
  • Covered entities must begin training its relevant employees no later than 30 days after a covered entity implements its policies and procedures.
  • Covered entities with fifteen or more employees must designate at least one employee to serve as a Coordinator to integrate efforts to comply with and carry out responsibilities under section 1557.

The 2024 Final Rule will take effect on July 5, 2024.

For questions about the Final Rule, please contact Natasha Sumner or another member of our Healthcare Regulatory team.

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Photo of Natasha Sumner Natasha Sumner

Natasha co-leads the firms’ Psychedelics and Emerging Therapies Practice Group and is also part of the product liability team. She focuses her practice on assisting clients in navigating the regulatory scheme for conducting clinical trials on psychedelics and other controlled substances and litigating

Natasha co-leads the firms’ Psychedelics and Emerging Therapies Practice Group and is also part of the product liability team. She focuses her practice on assisting clients in navigating the regulatory scheme for conducting clinical trials on psychedelics and other controlled substances and litigating product liability claims.

Natasha is well-versed in historical and current psychedelic research including recent FDA-approved studies on MDMA and psilocybin use for mental health and end-of-life issues, the legalization and decriminalization of psylocibin in numerous cities and states, and biotech and pharmaceutical research. Natasha’s interest in this area keeps her at the forefront of assisting clients in navigating regulatory uncertainty, legislative advocacy, corporate transactions, and ­­­­­­­­­­litigation in this rapidly evolving complex area. Natasha is also dedicated to insuring diversity, equity, and inclusion and recognizing and preserving indigenous knowledge.

Academic institutions, product manufacturers and commercial businesses are among the clients relying on Natasha’s broad experience. Natasha has defended clients against claims of mold, asbestos, and benzene exposure, including landlords and housing authorities in disputes regarding habitability. She has represented clients alleging violations under the Food, Drug, and Cosmetic (FD&C) Act, and counseled clients regarding California’s Proposition 65 warning requirements, among other state and federal laws.

While in law school, Natasha interned with the California Attorney General Energy Task Force, working on antitrust issues related to the state’s 2001 energy crisis. Her inside view of regulatory issues is appreciated by clients as she navigates them through various complex litigation and compliance.