HHS Finalizes Section 1557 Nondiscrimination Rule

“Covered Entities” Include all RHCs

NARHC Washington DC

The Department of Health and Human Services (HHS), through the Office of Civil Rights (OCR) recently released a final rule regarding section 1557 of the Affordable Care Act (ACA), titled Nondiscrimination in Health Programs and Activities.

Section 1557 “prohibits discrimination on the basis of race, color, national origin, sex, age, or disability” in specified health programs or activities. The rule contains a broad definition for “covered entities” which includes any healthcare provider that “receives Federal financial assistance” which in this case means any provider who receives reimbursement from Medicare, Medicaid, CHIP or any Affordable Care Act Marketplace plan.

Therefore, the requirements in this rule will apply to almost all health care providers and effectively all Rural Health Clinics.

Regulations implementing these nondiscrimination provisions were first implemented by the Obama Administration in 2016, subsequently relaxed by the Trump Administration in 2020, and are now being ratcheted back up by the Biden Administration with the issuance of this final rule.

In particular, the Biden final rule re-introduces specific patient notification requirements, expands nondiscrimination policies into telehealth/clinical decision support tools, and requires covered entities to both develop and train staff on Section 1557 policies and procedures.

While the full rule is broadly applicable to the healthcare industry, the following sections are the most immediate and relevant sections of the rule for Rural Health Clinics.

Section 1557 Coordinator § 92.7

Entities with 15 or more employees must have a civil rights grievance procedure and an employee (or several) designated to coordinate compliance with the requirements in this rule. The Section 1557 Coordinator will be responsible for:

1. receiving and reviewing grievances;
2. coordinating Section 1557 recordkeeping requirements;
3. coordinating language access procedures;
4. coordinating effective communication procedures;
5. coordinating procedures for providing reasonable modifications for individuals with disabilities; and
6. coordinating training of relevant employees

The section 1557 coordinator(s) must be designated in our Rural Health Clinics before November 2nd, 2024 (120 days after the effective date).

Policies and Procedures Requirements § 92.8

All covered entities must implement written policies and procedures designed to comply with these nondiscrimination rules. The nondiscrimination policy must clarify that:

1. the covered entity does not discriminate on the basis of race, color, national origin, sex, age, or disability;
2. the covered entity provides language assistance service and appropriate auxiliary aids free of charge;
3. the covered entity will provide reasonable modifications for individuals with disabilities and
4. include the contact information for the Section 1557 Coordinators (if applicable)

In addition to the above, a covered entities’ P&Ps should include grievance procedures (for organizations with 15 employees or more), language access procedures, effective communication procedures, and reasonable modification procedures. Written policies must be in effect by July 5th, 2025.

Training § 92.9

All covered entities must train relevant employees on the civil rights policies and procedures required by this rule within a year. All relevant new employees must be trained on these procedures within a reasonable period of time after the employee is hired. All employees need to be kept apprised of any changes to the civil rights policies, and all covered entities must document their employees’ completion of this training and maintain the documentation for 3 calendar years. Staff must be trained by July 5th, 2025.

Notice of Nondiscrimination § 92.10

As you can see in the sample notice here, the notice of nondiscrimination is designed to inform patients that our RHCs do not discriminate or treat people less favorably on the basis of their race, color, national origin, age, disability, or sex. The notice provides contact information for both the “Civil Rights Coordinator” within your office as well as the Office for Civil Rights Complain Portal.

This “Notice of Nondiscrimination” must be provided to all patients on an annual basis and upon request.

This notice must be provided in no smaller than 20-point sans serif font and be posted on your website in a “conspicuous” location and in your office in a “prominent” physical location.
The Notice of Nondiscrimination is only required to be posted in English, however covered entities are required to provide translations as necessary to provide meaningful access.

Notice of Availability § 92.11

Separate from the Notice of Nondiscrimination, the “Notice of Availability” informs your patients that translation services are available free of charge. HHS has provided a sample here. This Notice of Availability must be provided in English as well as the 15 most common languages spoken by people with Limited English Proficiency (LEP) in your state.

Like the Notice of Nondiscrimination, the Notice of Availability must be provided in 20-point sans serif font.

Unlike, the Notice of Nondiscrimination, HHS has published a very specific list of documents which must include the Notice of Availability in English as well as the top 15 foreign languages in your state. Previously, under the Obama era rules, the taglines were required on “significant communications” but due to the confusion and ambiguity surrounding what constituted a “significant” communication, the Biden era rule has a very specific list of documents where the Notice of Availability is expected:

• wherever the notice of nondiscrimination is posted
• the notice of privacy practices required by the implementing regulations for the Health Insurance Portability and Accountability Act;
• application and intake forms;
• notices of denial or termination of eligibility, benefits, or services, including Explanations of Benefits (EOBs), and notices of appeal and grievance rights;
• communications related to a person's rights, 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 power of attorney, or living will (with an option of providing only one notice for all documents bundled together);
• discharge papers;
• complaint forms;
• patient and member handbooks;
• communications related to the cost and payment of care with respect to an individual, including medical billing and collections materials, and good faith estimates.

Should covered entities wish to reduce the burdens of these notifications, HHS does allow patients to “opt out” of receiving the Notice of Availability on an annual basis. Furthermore, covered entities are allowed to document a patient’s primary language and provide the Notice of Availability only in that language.

Patient Care Decision Support Tools § 92.210 and Telehealth § 92.211

Covered entities must take steps to “identify and mitigate discrimination when they use patient care decision support tools,” if you are utilizing artificial intelligence or other clinical algorithms at your RHC. Providers will have an ongoing responsibility to ensure that if they use patient care decision support tools, then providers must ensure that those tools do not yield discriminatory care. Covered entities should have a policy in place to mitigate the risk of discrimination from the use of AI and other patient care support tools.

Separately, this final rule prohibits covered entities from discriminating through their telehealth offerings. As such, you may want to consider how patients with limited English proficiency, or with disabilities might interface with your telehealth offerings.

Nondiscrimination on the Basis of Sex

Consistent with the US Supreme Court ruling in Bostock v. Clayton County, the rule clarifies that “that discrimination on the basis of sex includes discrimination on the basis of sex stereotypes; sex characteristics, including intersex traits; pregnancy or related conditions; sexual orientation; and gender identity.”

The accompanying FAQ clarifies that the rule does not require providers to offer gender-affirming care if the providers do not think it is clinically appropriate or if a religious freedom and conscience protection applies. Covered entities may apply for a religious exemption to exempt themselves from aspects of the rule.

What is the Effective Date of this Rule?

The effective date of the final rule is 60 days after publication in the Federal Register. This will likely be July 5, 2024.

Section 1557 Provider-Relevant Provisions

Section 1557 Requirement and Description	Covered entities must comply by:
§ 92.7 Section 1557 Coordinator	Within 120 days of effective date (anticipated November 2, 2024)
§ 92.8 Policies and Procedures	Within one year of effective date (anticipated July 5, 2025)
§ 92.9 Training	After the creation of a covered entities P&P and no later than one year after effective date (anticipated July 5, 2025)
§ 92.10 Notice of Nondiscrimination ~ Longer notice required in English explaining Nondiscrimination rules to patients	Within 120 days of effective date (anticipated November 2, 2024)
§ 92.11 Notice of Availability ~ Shorter notice in English and top 15 foreign languages explaining the availability of translation and auxiliary aid services free of charge	Within one year of effective date (anticipated July 5, 2025)
§ 92.210 Patient Care Decision Support Tools	Within 300 days of effective date (anticipated May 1, 2025)

Enforcement

These requirements will be enforced by the Office of Civil Rights. Individuals may file complaints directly if they believe they have been discriminated against and a complaint may result in an investigation of the allegation. If a violation is found, the OCR works with the covered entity to achieve compliance with the regulation. If voluntary compliance cannot be achieved, OCR can issue a formal findings letter and refer the case to DOJ or begin administrative proceedings to revoke federal funds.

Other Resources

NARHC anticipates that the RHC community will have numerous questions regarding this rule and associated requirements. Stay tuned for continued resources to help navigate these new requirements.

CMS has released additional resources linked below:

• Rule
• HHS / OCR Overview
• Fact Sheet
• FAQs
• Notices / Translation Resources

Please contact Sarah.Hohman@narhc.org with any questions.