OCR Shores Up Access to Healthcare with Nondiscrimination Protections

Access to quality healthcare services has long been a priority of the U.S. Department of Health and Human Services (HHS), and through its Office for Civil Rights (OCR) this agency has, since at least 2001, sought to provide protections and enforcement intended to reduce or eliminate barriers to healthcare. OCR's regulatory authority makes it "uniquely placed at the intersection of privacy and non-discrimination."

As previously reported, OCR issued final rules in May 2024 that strive to reassure patients that sharing information with their healthcare providers related to diagnosis, treatment, services and medications for substance use disorder and reproductive health treatments would not result in adverse external consequences, specifically criminal prosecution. Healthcare providers are handicapped in delivering care when less than complete information is available. In addition to mitigating fear that could serve as a barrier to the free exchange of healthcare information, HHS has recognized other hurdles to care arising from discriminatory practices, intended or not, related to language, sexual orientation and physical access. Following the Supreme Court decision in Bostock v. Clayton County, 590 U.S. 644 (2020), the Biden Administration issued a 2021 Executive Order requiring that all federal agencies review regulations and processes to enforce prohibitions on sex discrimination and again later that year released an Executive Order addressing racial inequity in healthcare. A notice of proposed rulemaking by HHS seeking amendments of Section 1157 of the Affordable Care Act (ACA) in response to these Executive Orders soon followed in 2022 and, in April 2024, HHS released the final rule containing comprehensive regulatory amendments and new regulations implementing Section 1157 prohibitions on discrimination in healthcare.

Nondiscrimination in Access to Care

Section 1557 prohibits discrimination by nearly all healthcare providers in health programs or activities receiving federal financial assistance on grounds prohibited by: 1) Title IV of the Civil Rights Act of 1964 (race, color and national origin), 2) Title IX of the Education Amendments of 1972 (sex), 3) The Age Discrimination Act of 1975 (age) and 4) Section 504 of the Rehabilitation Act of 1973 (disability). As of July 5, 2024, Section 1157 applies to nearly all healthcare providers: all Medicare and Medicaid providers and other healthcare providers receiving federal financial assistance (grant (i.e., the Coronavirus Aid, Relief, and Economic Security Act (CARES) Act Provider Relief Fund), loan, credit (i.e., advance payment of tax credits), subsidy (cost sharing reductions or subsidies), contract (other than a procurement contract) or other federal assistance. The scope of regulated "covered entities" also includes those organizations that are indirect recipients of HHS funding.

The recently amended regulations continue to be the subject of litigation. As noted by HHS on its Section 1557 webpage, the current federal courts have enjoined nationwide enforcement of certain provisions related to gender identity protections and sex discrimination and stayed the effective date of the impacted regulations. However, Section 1557 has long protected discrimination related to limited English proficiency (LEP), hearing and sight language disabilities, and physical disabilities and continues to require compliance updates and attention in these areas.

OCR Emphasizes Language Access Services

To encourage industry compliance, OCR frequently issues guidance and interpretations to assist healthcare providers, health plans and others with adherence to civil rights regulations. For example, on Dec. 9, 2024, OCR issued a "Dear Colleague" letter to provide guidance regarding the language access provisions of Section 1557 designed to serve individuals with LEP. In its letter, OCR noted that 68 million people in the U.S. speak a language other than English at home, and 8.2 percent of those people do not speak English well. Language access tends to "affect the most vulnerable members of society who are likely to participate in health programs," according to OCR. Citing studies showing that communication barriers impede quality care, leading to negative health outcomes, OCR stated that "the provision of language access services is not only a legal obligation but necessary for patient care." Additionally, "a covered entity should not assume that merely because an individual speaks some English, the individual is proficient in English as it concerns the service at issue."

For individuals with LEP, entities subject to Section 1557 "must take reasonable steps to provide meaningful access." These entities must ensure that language issues will not prevent patients from obtaining needed services and care. Requirements include the following, and further information is available at OCR's Section 1557 webpage:

• Language Assistance Services. These services must be free, accurate and timely. They must also protect independent decision-making and privacy.
• Use of a Qualified Interpreter. If interpretation is requested, the hospital, state health department, a nonprofit provider funded by HHS or other covered entity subject to Section 1557 must offer an interpreter who is proficient in English and at least one other language and who can interpret "effectively, accurately, and impartially." The interpreter can provide services remotely or on site. Covered entities may not require individuals with LEP to provide or pay for their own interpreters. Unqualified adults may interpret only temporarily in certain emergencies and other limited situations.
• Use of a Qualified Translator. For written documents, if translation services are requested, the covered entity must use a qualified translator who is proficient in writing both written English and at least one other written non-English language. An employee's self-identified proficiency will not comply with Section 1557 unless the employee is actually proficient.
• Proper Use of Machine Translation. With the proliferation of online translation services and apps, covered entities may be tempted to rely on technology rather than human translators. OCR has indicated that when machine translation is used, those automated translations must be reviewed by a qualified human translator in situations where accuracy is essential, when source documents or materials contain complex, nonliteral or technical language, or when the underlying text is critical to the individual's rights, benefits or meaningful access. Exceptions may apply in exigent circumstances.
• Notices of Nondiscrimination. Participants, beneficiaries, enrollees and health program applicants, as well as members of the public, must be provided with a notice of nondiscrimination containing a number of specific provisions such as information on the availability of accessibility services and language assistance.
• Notices of Availability. Covered entities must also provide a notice that language assistance and auxiliary aids and services will be provided free of charge when necessary. The notice must be provided in English and in at least the 15 most commonly spoken languages by individuals with LEP in the relevant states where the covered entities operate, as well as in alternative formats for individuals with disabilities. There are specific requirements for the format of the notice and how often it must be provided.

OCR Enforcement of Section 1557 and Private Right of Action

OCR is tasked with enforcing a laundry list of federal civil rights laws, not limited to those associated with delivery of healthcare services, and has actively protected access to healthcare for persons since its first healthcare resolution agreement in 2006. This enforcement path of more than 18 years has led to over 75 settlement agreements between OCR and healthcare providers, state health agencies and insurers and resolution of innumerable complaints through voluntary corrective action and technical assistance. Although Section 1557 is based on four antidiscrimination statutes, OCR may also separately enforce (and has enforced) the underlying nondiscrimination laws. In 2024, OCR also amended Section 504 of the ADA to provide for greater disability access to web content, mobile apps, kiosks and medical technology. In addition to federal enforcement, healthcare providers and insurers should be cognizant of state nondiscrimination laws and the private right of action alternative for individuals who are discriminated against.

Timeline and Recommended Compliance Steps

The timeline for implementation of Section 1557 obligations was set out by OCR in its Fact Sheet and has staggered applicability dates beginning on July 5, 2024. Those not effective on July 5, 2024, are listed here:

• 1557 Coordinator (Section 92.7). 120 days from July 5, 2024: Nov. 2, 2024.
• Policies and Procedures (Section 92.8). One year from July 5, 2024: July 5, 2025.
• Training (Section 92.9). Following a covered entity's implementation of the policies and procedures required by Section 92.8, and no later than one year from July 5, 2024: July 5, 2025.
• Notice of Nondiscrimination (Section 92.10): 120 days from July 5, 2024: Nov. 2, 2024.
• Notice of Availability of language assistance and auxiliary aids (Section 92.11): One year from July 5, 2024: July 5, 2025.
• Section 92.207(b)(1) through (5). For health insurance coverage or other health-related coverage that was not subject to this part as from July 5, 2024, by the first day of the first plan year (in the individual market, policy year) beginning on or after Jan. 1, 2025.
• Section 92.207(b)(6). By the first day of the first plan year (in the individual market, policy year) beginning on or after Jan. 1, 2025.
• Patient care decision support tools Section 92.210(b) and (c). 300 days from July 5, 2024: May 1, 2025.

Recommended actions:

• assess translation and interpretation services for compliance
• assess website accessibility, kiosks and other patient-facing technology for compliance with ADA Section 504
• post notices of nondiscrimination on websites and at all physical locations
• appoint 1557 Coordinator
• review and revise or prepare policies and procedures
• prepare training
• review decision support tool and artificial intelligence transparency disclosures or discuss with health IT vendors and assess uses of decision support tools to assure nondiscriminatory decision making

Earlier in This Series

For more on regulatory developments at OCR, please see Holland & Knight's previous alerts in the OCR in Overdrive series.

• Part 1: "Reproductive Healthcare Privacy Rule Brings New Requirements for All Providers," May 10, 2024
• Part 2: "What HIPAA Security Rule Surprises Await Healthcare Providers for the Second Half of 2024?," May 13, 2024
• Part 3: "HIPAA Breach Notice Can Be Delegated to Change Healthcare," June 4, 2024
• Part 4: "Safeguarding Health Information: Takeaways from HHS and NIST 2024 HIPAA Security Conference," Oct. 30, 2024

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.