The Department of Health and Human Services (HHS) has issued a proposed rule to advance health equity and reduce disparities in health care. The proposed rule, Nondiscrimination in Health Programs and Activities, revises the implementing regulation for Section 1557 of the Affordable Care Act (ACA), and proposes robust provisions that will be more effective in protecting people from discrimination. Section 1557 of the ACA prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs or activities and is one of the government’s most powerful tools to ensure nondiscriminatory access to health care. In addition to proposing revisions to the Section 1557 implementing regulation, this rulemaking also includes proposed revisions to nondiscrimination provisions in Centers for Medicare & Medicaid Services (CMS) regulations. The Department is engaging in this proposed rulemaking to strengthen and reinstate protections from discrimination in health programs and activities, consistent with the statutory text of Section 1557, congressional intent, legal precedent, and the Biden-Harris Administration’s priority of advancing equity and civil rights and protecting Americans’ access to health care. The proposals in this Notice of Proposed Rulemaking draw on extensive stakeholder engagement, the Department’s enforcement experience, and developments in civil rights law. While the Department is undertaking this rulemaking, both the statute and the current regulation are in effect. If you believe that you or another party has been discriminated against on the basis of race, color, national origin, sex, age, or disability, visit the Office for Civil Rights (OCR) complaint portal to file a complaint online. Summary of the Proposed Rule Reinstates application to all Department of Health and Human Services’ administered health programs and activities. The proposed rule applies the same nondiscrimination standards to the Department’s health programs and activities as are required of federal funds recipients. The 2020 Rule (85 Fed. Reg. 37160 (June 19, 2020)) limited the scope of Section 1557’s nondiscrimination requirements to only those programs and activities conducted by the Department under Title I of the ACA. The Department believes that interpreting Section 1557 to cover all of the health programs and activities administered by the Department is the best reading of the statutory language, and the one that provides protection from discrimination to people in more programs. This demonstrates the Department’s commitment to ensuring that individuals are not subject to discrimination across the broad range of health programs and activities it conducts, including but not limited to the Indian Health Service, Centers for Medicare & Medicaid Services, and the National Institutes of Health. Clarifies the application of Section 1557 nondiscrimination requirements to health insurance issuers. The proposed rule, consistent with congressional intent and court precedent, reinstates and strengthens application to health insurance issuers that receive federal financial assistance. Recognizing the significant role health insurance issuers play in the provision of health care, this proposed rule provides clear nondiscrimination standards for the industry. Aligns sex discrimination regulatory requirements with Federal court decisions. The proposed rule codifies protections against discrimination on the basis of sex as including discrimination on the basis of sexual orientation and gender identity. These protections are consistent with the U.S. Supreme Court’s holding in Bostock v. Clayton County, 140 S. Ct. 1731 (2020), and the Department’s subsequent Federal Register Notice (86 Fed. Reg. 27984 (May 10, 2021)) that Section 1557 would be enforced consistent with this decision that sex discrimination includes discrimination on the basis of sexual orientation and gender identity. In addition, the proposed rule clarifies that sex discrimination includes discrimination on the basis of sex stereotypes; sex characteristics, including intersex traits; and pregnancy or related conditions including pregnancy termination. Requires covered entities to have Section 1557 policies and staff training. The proposed rule, for the first time, requires recipients of federal financial assistance, the Department’s health programs and activities, and State Exchanges to implement Section 1557 anti-discrimination policies and procedures to give staff clear guidance on the provision of language assistance services for limited English proficient (LEP) individuals, and effective communication and reasonable modifications to policies and procedures for people with disabilities. Covered entities will also be required to train relevant staff on these policies and procedures. These requirements will help improve compliance and reduce the need for enforcement. Requires covered entities to provide notice of the availability of language assistance services and auxiliary aids and services. The proposed rule requires covered entities to provide notice of the availability of language assistance services and auxiliary aids and services in English and at least the 15 most common languages spoken by LEP persons of the relevant state or states. These notices must also be provided in alternate formats for individuals with disabilities who require auxiliary aids and services to ensure effective communication. Covered entities would be required to provide these notices on an annual basis, upon request, in prominent physical locations, and in a conspicuous location on their websites. The proposed rule also allows individuals to opt-out of receiving an individualized notice on an annual basis. Puts covered entities on notice of nondiscrimination requirements’ application to use of clinical algorithms. The proposed rule states that a covered entity must not discriminate against any individual on the basis of race, color, national origin, sex, age, or disability through the use of clinical algorithms in its decision-making. This provision is not intended to hinder the use of clinical algorithms; but to prevent discrimination given the recent increasing reliance on clinical algorithms in health care decision-making. Provides a clear process for raising conscience and religious freedom objections. The proposed rule provides a clear process by which recipients of federal financial assistance from the Department can notify OCR of their belief that the application of a specific provision or provisions of Section 1557 would violate their rights under federal conscience or religious freedom laws. For the first time, OCR clarifies that when it receives such a notification from a recipient, it shall promptly consider those views in responding to any complaints or otherwise determining whether to proceed with any investigation or enforcement activity regarding that recipient’s compliance with the relevant provisions of the regulation. Any ongoing relevant investigation or other enforcement action regarding the recipient shall be held in abeyance until a determination is made as to whether a recipient is exempt from compliance with, or entitled to a modification of the application of, a provision of the rule. Additionally, the rule provides that after receiving notice, if there is a sufficiently concrete factual basis for doing so, OCR may at any time make a determination regarding whether a recipient is wholly exempt from or should receive an exemption or modification from certain provisions of the rule. Clarifies that nondiscrimination requirements apply to health programs and activities provided through telehealth services. The proposed rule specifically addresses nondiscrimination in the provision of health programs and activities through telehealth services. Telehealth is a means by which covered entities provide their health programs and activities. This provision clarifies that covered entities have an affirmative duty to not discriminate in their delivery of such services through telehealth. This duty includes ensuring that such services are accessible to individuals with disabilities and providing meaningful program access to LEP individuals. Such services would include communications about the availability of telehealth services, the process for scheduling telehealth appointments (including the process for accessing on-demand unscheduled telehealth calls), and the telehealth appointment itself. Interprets Medicare Part B as federal financial assistance. The proposed rule announces the Department’s position that Medicare Part B is federal financial assistance for the purpose of coverage under the federal civil rights statutes the Department enforces. These include Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, Title IX of the Education Amendments of 1972, the Age Discrimination Act of 1975, and Section 1557 of the ACA. Medicare Part B funds meet the definition of federal financial assistance under the law, as provided in the implementing regulations for each of the aforementioned statutes. The Department believes that previous rationales provided for the Medicare Part B exclusion are not the best reading of the civil rights laws given the purpose and operation of the Medicare Part B program. Reinstates protections on the basis of gender identity and sexual orientation in Centers for Medicare & Medicaid Services regulations. The 2020 Rule amended ten provisions in the Centers for Medicare and Medicaid Services (CMS) regulations, all of which cover at least some entities that are also subject to Section 1557, to delete language that prohibited discrimination on the basis of sexual orientation and gender identity. These provisions included regulations governing Medicaid and the Children’s Health Insurance Program (CHIP); Programs of All Inclusive Care for the Elderly (PACE); health insurance issuers and their officials, employees, agents, and representatives; States and the Exchanges carrying out Exchange requirements; agents, brokers, or web-brokers that assist with or facilitate enrollment of qualified individuals, qualified employers, or qualified employees; issuers providing essential health benefits (EHB); and qualified health plan (QHP) issuers. CMS proposes to amend these regulations in this Section 1557 proposed rule so that they again identify and recognize discrimination on the basis of sexual orientation and gender identity as prohibited forms of discrimination based on sex. In addition, CMS proposes to amend its own regulations applying these protections in CHIP to also apply to Medicaid fee-for-service programs and managed care programs. These proposals are consistent with those elsewhere in this proposed rule and would promote consistency across HHS programs by prohibiting discrimination based on sexual orientation or gender identity. Public Comment The proposed rule seeks comment on a variety of issues to better understand individuals’ experiences with health care discrimination and covered entities’ experiences in complying with federal civil rights laws. The comment period will be open for 60 days for members of the public to provide comments on the proposed rule. OCR will consider those comments as it drafts a final rule to implement Section 1557. The Department will also be conducting a Tribal consultation meeting on August 31, 2022 from 2:00 p.m. to 4:00 p.m. Eastern Daylight Time. To participate, you must register in advance at https://www.zoomgov.com/meeting/register/vJIsfu-rqzksEl2T8gUp_lDrWBqkU0223CY. The NPRM may be viewed or downloaded at: https://www.federalregister.gov/public-inspection/2022-16217/nondiscrimination-in-health-programs-and-activities. The text of the regulation in English is available at https://www.regulations.gov/. Translated summaries of the regulation will be available soon at www.hhs.gov/ocr. If you need the regulation or summary in an alternate format, please call (800) 368-1019 or (800) 537-7697 (TDD) for assistance or email email@example.com. You can submit comments, identified by RIN 0945-AA17, electronically through https://www.regulations.gov, or by mail or via hand delivery or courier to the following address only: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: 1557 NPRM (RIN 0945-AA17), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue SW., Washington, DC 20201. For more information, please go to OCR’s website at www.hhs.gov/ocr.