Who is Affected?

The Rule applies to (1) every healthcare organization that receives funding from HHS, including organizations that participate in Medicare Part A or Part B, CHIP, or Medicaid programs, (2) every health program administered by HHS and (3) every health program that is on State Exchanges or Federally-facilitated Exchanges. This summary primarily focuses on the first category of entities.

What Obligations are Imposed?

The Rule’s purpose is to protect individuals from discrimination on the basis of race, color, national origin, sex, age, or disability, in certain health programs or activities. Generally, an entity may not prohibit access to health services or insurance on the basis of these protected classes.

To help achieve these goals, the Rule imposes the following obligations:

Written Policies and Procedures.

The entity must implement written policies and procedures for compliance with the Rule. This policy must (1) include a statement that the entity does not discriminate, (2) (if the entity employs more than fifteen employees) include a written grievance procedure, (3) implement written language access procedures, (4) describe how the entity effectively communicates with individuals with disabilities, and (5) describe how the entity makes reasonable accommodations to avoid discrimination on the basis of disability.

Training.

The entity must train its relevant employees on how to comply with the policies and procedures the entity implements. A relevant employee is any employee who interacts with patients or members of the public, makes decisions that affect health care, or performs tasks that may affect a patient’s financial obligations.

Designation of Section 1557 Coordinator.

Most covered entities must designate a “Section 1557 Coordinator.” This individual will be responsible for ensuring compliance with the Rule. These responsibilities include investigating grievances, coordinating the written policy requirements, and training coordination.

Notice of Nondiscrimination.

The entity must provide a notice to individuals that provides:

• That the entity does not discriminate,
• That the entity provides reasonable modifications for individuals with disabilities,
• That the entity provides language assistance services,
• How to obtain such reasonable modifications,
• The contact information of the Section 1557 Coordinator,
• How to file a grievance,
• How to file a complaint with the OCR, and
• How to access the entity’s website that contains this notice.

This notice must be (i) provided to individuals annually, (ii) upon request, (iii) in a conspicuous location on the entity’s website, and (iv) in a clear and prominent location where individuals would expect to receive notice.

Provide Meaningful Access for Individuals with Limited English Proficiency and Notice of Access.

The entity must take reasonable steps to ensure individuals with limited English proficiency are not discriminated against. To provide this access, an entity may need to provide free and accurate language assistance services, a qualified translator, or machine translation. The entity also must provide notice that it offers these services in English and at least 15 of the most common languages spoken by individuals with limited English proficiency in the state in which the entity operates.

Meaningful Access for Individuals with Disabilities.

The Rule has a number of requirements to ensure entities do not discriminate against individuals with disabilities. The entity must effectively communicate with individuals with disabilities. The entity’s facilities and information technology must be accessible. The entity must modify its policies to avoid discriminating on the basis of disability.

Technology Provisions.

The Rule calls out certain technologies where entities must make a specific effort not to discriminate. These technologies include patient care decision support tools and telehealth services

Assurance of Compliance.

A covered entity must submit an assurance that it is in compliance with the Rule. This requirement may be familiar, as other laws, such as Title VI and Section 504, require a similar assurance. While new Medicare and Medicaid recipients only need to submit such an assurance once, HHS only recently added a Section 1557 assurance to HHS Form-690. Thus, an entity should consider resubmitting an assurance of compliance if it has not in several years.

When Must Covered Entities Comply?

While the prohibition against discrimination is already in effect, the Rule has several effective dates for the obligations it imposes to achieve this end:

What Penalties May the OCR Impose For Failure to Comply?

OCR may use the procedures under Title VI of the Civil Rights Act to enforce the Rule. OCR may pursue informal methods, such as seeking the entity’s cooperation, requiring the entity submit compliance reports, and conducting investigations. OCR also may seek an administrative hearing, which could result in penalties such as suspension, termination, or exclusion from federal health care programs. OCR further may refer the entity to the DOJ and recommend bringing appropriate proceedings against it. Finally, there exists a private right of action, although damages are somewhat limited by the Supreme Court’s decision in Cummings v. Premier Rehab Keller, 596 U.S. 212 (2022).

If you believe you or your organization may be a covered entity and would like advice on what changes you should make in order to comply with the Rule, please contact an attorney in our Health Law practice group, including Dan Weinreb, Kristi O’Brien and Luke Campbell.