HHS issues regulations to strengthen anti-discriminatory protections in healthcare (updated)

July 3 update

A judge with the Southern District of Mississippi federal court granted an injunction preventing the Biden administration from enforcing regulations expanding anti-discrimination protections in the Affordable Care Act (ACA).

Issued two days before the new rule was to take effect, the order applies to the provisions concerning gender identity.

The move came in response to a request from 15 states that filed a lawsuit stating the rule would require their Medicaid programs to “use taxpayer funds to pay for unproven and costly gender-transition interventions” or risk forfeiting billions of dollars in federal funding as a result of noncompliance.

The court agreed that the rule would “cause concrete, imminent injury in the form of compliance costs” and said the plaintiffs have established “a substantially [sic] likelihood that HHS exceeded its statutory authority” in the new rule, specifically by expanding the definition of on the basis of sex to include gender identity in the context of anti-discrimination protections.

Referenced in the decision is the Supreme Court’s landmark June 28 ruling overturning the Chevron precedent, which had given agencies such as HHS and CMS a presumption of authority in written regulations when statutes were ambiguous or incomplete. That presumption no longer exists, the high court said, and statutory language must hold sway.

In this case, according to the Mississippi court, the relevant statutes are Title IX and the ACA, and neither mentions gender identity.

HHS based part of its counterargument on a 2020 Supreme Court ruling in favor of plaintiffs who had filed lawsuits against their employers after being terminated allegedly because they were homosexual or transgender. The high court said the definition of sex was immaterial in that case.

A key difference with respect to the latest case, the Mississippi court said, is that it hinges on statutory language in Title IX, while the prior case was based on Title VII of the Civil Rights Act.

Original story

Healthcare providers should be aware of the compliance requirements in sweeping new federal regulations intended to improve health equity and reduce healthcare disparities.

An HHS final rule expands upon Affordable Care Act (ACA) Section 1557 language that has prohibited discrimination on the basis of characteristics such as race, color, national origin (including English proficiency), age, disability and sex.

The rule was drafted, in part, to reverse the scaled-back provisions implemented by a 2020 rule, including the latter rule’s reduction of notification requirements. By early November — 120 days after the July 5 effective date of the new rule — covered entities must assign someone to the role of Section 1557 coordinator to guide compliance.

Although Section 1557 always applied to healthcare providers and health plans that receive federal financial assistance, the new rule expands the definition of covered entity to include additional categories of insurers and providers.

These include commercial insurers and short-term, limited-duration plans if the parent company receives federal funds.

“When determining whether an entity’s subsidiaries or other entities are legally separate from the federally funded activities, OCR [the HHS Office of Civil Rights] may consider — among other things — the organizational structure and the interrelatedness between the entities, such as the degree of common ownership, management and control between the entities, and whether the entities share centralized control of labor relations,” the rule states.

In another change, starting in May 2025, the requirements will apply to any provider that receives Medicare Part B payment even if that is the provider’s only form of federal financial assistance.

Despite the early-July effective date of the new rule, implementation of some of the key components will be delayed until late 2024 or 2025. An FAQ on the new rule is available.

Language assistance requirements

The rule fortifies requirements to make available written and oral language-assistance services and auxiliary aids and services at no cost. Those provisions take effect in July 2025 and more or less mirror obligations that had been in place prior to the 2020 rule.

Patients also must have access to qualified interpreters and translators, except in emergency situations, when providers can instead make available a bilingual staff member or another adult (who is not accompanying the patient).

The organization must ensure a qualified human translator reviews any machine-based translation with respect to communications on the rights, benefits or access of an individual with limited English proficiency, as well as in certain other circumstances.

A written notice of the availability of language assistance must be provided and translated into the 15 most common non-English languages in the organization’s home state. These notices must be:

• Posted by the organization on-site and online
• Distributed upon request
• Included with a number of other required notices (e.g., HIPAA requirements, billing and collections materials, good-faith estimates, patient handbooks)

In 2022 comments on the proposed version of the rule, the American Hospital Association (AHA) supported the language-assistance provisions generally but said such notification in 15 languages “requires a great deal of resources for services that may not be required in every community.”

A better alternative would have entailed “a more flexible standard permitting a precise focus on languages spoken in the particular communities served,” the AHA wrote.

Providers also must ensure communication of such services is as effective for people with disabilities (e.g., hearing impairment) as it is for patients generally. Staff must be trained on the policies and procedures, including how to contact qualified interpreters and translators as needed.

Other increased protections

Seeking to reduce disparities in healthcare access and coverage, the new rule incorporates sexual orientation, gender identity, sex characteristics and sex stereotypes in protections against sex-based discrimination. The protections apply in Medicaid, the Childrens Health Insurance Program, the ACA marketplaces and the Program of All-Inclusive Care for the Elderly after the 2020 rule exempted those programs.

Pregnancy and related conditions will be protected from sex-based discriminatory practices, per the new rule.

With respect to termination of pregnancy, the new rule clarifies that individuals still can decline to provide services because of religious or conscience-related objections or based on a professional or business judgment.

But such decisions cannot vary based on protected characteristics (e.g., the mother’s age, race or disability status), and patients cannot be regarded differently based on their pregnancy-related choices.

Technology-related requirements

Providers and other covered entities also must ensure their utilization of clinical decision-support tools is nondiscriminatory on the basis of protected characteristics. The requirements are scheduled to begin 300 days after the effective date of the final rule, meaning May 1, 2025.

The regulations define such tools as “any automated or nonautomated tool, mechanism, method, technology or combination thereof used by a covered entity to support clinical decision-making in its health programs or activities.”

Tools used on the finance and administrative side are not covered by the rule. These include algorithms deployed in billing, coding, patient scheduling and any staffing-related activities.

In its 2022 comments, the AHA had urged HHS to “ensure that the final rule supports the appropriate use of race and/or other characteristics in clinical decision-making,” given that differences can provide insights into the appropriate course of treatment.

In the final rule, HHS wrote, “The rule does not seek to disrupt covered entities’ clinical decision-making, expose patients to greater health risks, or to prevent the use of these tools entirely.” Rather, the goal is to promote rigorous evaluations of the potential to deploy the tools in a discriminatory manner, the department explained.

HHS stressed that OCR will not be rigid in its assessment of possible violations. Among other factors, it will consider whether the covered entity has limited resources to devote to evaluating such tools, whether use of the tool is in keeping with guidance from the developer and regulators, and whether the organization has a process for evaluating the tools in this context.

The protections against discrimination also apply to telehealth services, HHS stated, including for people with limited English proficiency or disabilities. Protections also must be in place for technology such as mobile apps.