Section 1557 of the Affordable Care Act (ACA) prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain healthcare activities. Among other requirements, all healthcare providers that receive, directly or indirectly, federal financial assistance, including but not limited to participation in Medicare or Medicaid must now provide a notice of availability of language assistance services free of charge. The US Department of Health and Human Services’ (HHS) new set of requirements was finalized in April 2024.
Background
Since the ACA’s origination, a series of rules have been passed to implement Section 1557 (42 USC 18116). From July 18, 2016 to August 17, 2020, 45 CFR § 92.8 mandated that covered entities (covered entities include recipients of federal financial assistance, the US Department of Health and Human Services, and entities established under title I of the ACA) post “taglines” to convey language assistance services “[i]n significant publications and significant communications targeted to beneficiaries, enrollees, applicants, and members of the public.” Taglines were short statements written in languages other than English to identify the availability of language assistance services.
However, on June 19, 2020, CMS issued a rule repealing 45 CFR § 92.8, effective August 17, 2020. The rule “eliminate[d] the burdensome requirement for covered entities to send notices and taglines with all significant communications,” among other changes. Despite repealing this provision, the 2020 rule nonetheless maintained the requirement that “[a]ny entity operating or administering a health program or activity subject to this part shall take reasonable steps to ensure meaningful access to such programs or activities by limited English proficient individuals.” 45 CFR § 92.101(a). The requirement did not explain what constituted “reasonable steps.”
CMS issued a proposed rule in August 2022 to reimplement some of the 2016 provisions, including those related to taglines. 87 FR 47824. The proposed rule no longer called the short statements “taglines,” however, because the new corollary provision “also now requires a notice of the availability of auxiliary aids and services.”
New Requirement
On April 26, 2024, HHS issued its final rule.
By July 5, 2025, entities subject to Section 1557 must provide participants, beneficiaries, enrollees, and applicants of their health programs and activities, and the public, with an annual Notice of Availability regarding free language assistance services and auxiliary aids and services. The notice must also be displayed in a prominent location, both physically and online.
The notice is required in English “and at least the 15 languages most commonly spoken by individuals with limited English proficiency of the relevant State or States in which a covered entity operates.” 45 CFR § 92.11(b). For example, if a covered entity is operating in five states, they must provide notices of the availability of translation services in the top 15 most commonly spoken languages in those five states. HHS suggests determining the top languages by consulting resources and tools such as those available at lep.gov and data from the Census and American Community Survey.
The Notice of Availability must also accompany the following electronic and written communications:
- The Notice of Nondiscrimination
- The notice of privacy practices required by HIPAA
- Application and intake forms
- Notices of denial or termination of eligibility, benefits, or services, including an Explanation of Benefits, and notices of appeal and grievance rights
- Communications related to an individual's eligibility, benefits, or services that require or request a response from a participant, beneficiary, enrollee, or applicant
- Communications related to a public health emergency
- Consent forms and instructions related to medical procedures or operations, medical powers of attorney, or living wills
- Discharge papers
- Communications related to the cost and payment of care with respect to an individual, including medical billing and collections materials, and good-faith estimates provided pursuant to the No Surprises Act
- Complaint forms
- Patient and member handbooks
Individuals are allowed to opt out of the Notice of Availability.
Entities subject to the notice requirements should annually document the individual’s decision to opt out. An individual may opt out as long as (1) the individual is informed of the right to receive the notice upon request in their primary language through an appropriate auxiliary aid and service, (2) the receipt of any aid or service is not conditioned on the decision to opt out, and (3) opting out of receiving the notice is not a waiver of the individual’s right to receive language assistance services and any appropriate auxiliary aids and services.
Guidance from the US Department of Health & Human Services
HHS provides a sample Notice of Availability along with other resources for providers.
On December 9, 2024, HHS, Office for Civil Rights (OCR), issued a “Dear Colleague” letter to help federally funded health care providers, plan grantees, and others better understand their obligations under the new rule.
The letter offers definitions of an “individuals with limited English proficiency” and “meaningful access.” Moreover, the letter offers guidance on language assistance services, use of a qualified interpreter, qualified translator, and machine translation.
Relationship to HIPAA
HIPAA provides that individuals have a “right to adequate notice.” 45 CFR 164.520. While HIPAA does not have a specific requirement that a Notice of Privacy Practices be provided in multiple languages, failure to do so could be considered a HIPAA violation. Indeed, consistent with this consideration, the Federal Register comments to the 2013 HIPAA Final Rules note that “to the extent a covered entity is obligated to comply with Title VI of the Civil rights Act of 1964, the covered entity must take reasonable steps to ensure meaningful access for Limited English Proficient persons to the services of the covered entity, which could include translating the NPP into frequently encountered languages.” 78 FR 5566, 5625 (2013). However, “there is no ‘one size fits all’ approach.” Id. Factors such as entity size, provider sophistication, number of patients served, and patient populations all may be relevant factors.
HIPAA-regulated entities should be alert to whether the new Notice of Availability applies to their services.
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