The Department of Health and Human Services (HHS) finalized a rule reinstating certain regulatory protections against discrimination in healthcare that were stripped in a previous Trump-era rule.
The final rule expands Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination based on sex, race, color, national origin, age and disability for certain health activities, by codifying that Section 1557’s prohibition against discrimination based on sex includes LGTBQI+ patients, according to an HHS press release.
HHS' rule also clarifies that nondiscrimination applies to telehealth care and artificial intelligence used for patient care under the ACA.
Hospitals, providers and payers, among others, will now be on the hook for ensuring compliance with civil rights rules in health technology.
The rule applies to end users of AI, such as providers, hospitals and payers, and requires them to take steps to assess whether algorithms used for patient care collect or use information related to race, color, national origin, sex, age or disability to provide its insights and recommendations.
HHS’ Office for Civil Rights (OCR) issued its final Section 1557 nondiscrimination rule (PDF) April 26. The rule grants protection to additional categories of health information that can be the basis for discrimination in healthcare and adds telehealth and some AI tools to the nondiscrimination rule.
HHS officials said the 1557 final rule draws on "extensive stakeholder engagement" and a review of more than 85,000 comments from the public along with the department’s enforcement experience and developments in civil rights law.
Along with naming telehealth and AI, the rule gives additional protections to the categories of sexual orientation, gender identity, pregnancy or related conditions along with disability and limited English proficiency (LEP).
The rule also specifies that health insurers are subject to Section 1557 rulemaking and cannot deny, cancel, limit or refuse to issue or renew health insurance coverage based on protected traits. The rulemaking notes that people who identify as LGBTQI+, people with disabilities and people with LEP have been harmed by discriminatory insurance practices.
HHS OCR narrowed its definition of clinical AI from the proposed rule, changing the term to “patient care decision support tools.” These tools might conduct "screening, risk prediction, diagnosis, prognosis, clinical decision-making, treatment planning, healthcare operations, and allocation of resources," the rulemaking says.
The rule includes algorithms used by payers to make prior authorization decisions and medical necessity analyses.
OCR is requesting additional information on whether it should expand the scope of the rule to include algorithms used for billing and scheduling, which commenters said could result in discrimination.
OCR acknowledged comments by stakeholders that said AI end users could not always override bad algorithms. HHS added two “reasonability” standards to the final rule to safeguard AI users who cannot always prevent discriminatory outcomes.
If HHS receives a complaint of algorithmic discrimination, OCR will assess whether the organization reasonably attempted to identify algorithms that use characteristics like race and gender to provide recommendations. The second standard is whether the end user reasonably attempted to mitigate discrimination by the algorithm.
OCR did not include a provision suggested by commenters that would have required patient notification when AI is used in clinical care. OCR said patients could access this information by invoking their right of access under HIPAA.
The rule also prohibits discrimination in telehealth. The rule includes significant discussion of accessibility of telehealth by people who have a disability or have LEP. OCR will not require telehealth platforms to adhere to accessibility standards, as suggested by some commenters.
It noted ongoing rulemaking by OCR and the Department of Justice on the accessibility of web content and mobile apps. OCR says covered entities have flexibility in determining the accessibility of their platforms.
The rule requires covered entities to post notice of free language assistance services and auxiliary aids and services for people with disabilities or LEP. It also says covered entities must implement a civil rights grievance procedure and post notice informing patients of their civil rights under Section 1557.
In the rule, the Centers for Medicare & Medicaid Services (CMS) also clarifies the definition of sex discrimination as it applies to Medicaid, the Children’s Health Insurance Program, Programs of All-Inclusive Care for the Elderly and related groups. The new, unified definition across programs protects individuals from "discrimination based on sex characteristics, including intersex traits; pregnancy or related conditions; sexual orientation; gender identity; and sex stereotypes."
CMS also determined in the rule that Part B funds constitute federal financial assistance.