In July 2022, the US Department of Health and Human Services (HHS) announced a new proposed revision to the agency’s interpretation of Section 1557 of the Affordable Care Act (ACA) that could impact the lives of millions. In their Health Affairs article, the authors,Rohan Khazanch, Jennifer Tsai, Nwamaka D. Eneanya, Juyoun Han, and Aletha Maybank, elevate opportunities to apply this interpretation to address racism in clinical algorithms citing CERCA and Healing ARC among the powerful approaches to expand more equitable care.
Race-based clinical algorithms are widely used and deepen population-level racial inequities. Codifying interventions that redress racism in clinical algorithms into Section 1557 will build upon existing civil rights law and may help the administration leverage Section 1557 as a vehicle for advancing anti-racist health care.
The elevate a coordinated, national efforts to redress racism in clinical algorithms that relies on equity-oriented reforms centering on patient needs, intentional communication of legal obligations to all impacted entities, and active consideration of race-conscious policies as a reparative strategy.
Key Potential Implications Of Section 1557 § 92.210
Accountability Across All Covered Entities
The proposed rule recommends that covered entities be held liable for tools that they did not develop, particularly if discriminatory outcomes result from overreliance on algorithms in clinical decision-making. This means all members of the health care ecosystem — payors, health systems, and providers alike — will need to demonstrate due diligence in identifying and rectifying the use of inequitable tools.
Support For Race-Conscious Algorithms Which Explicitly Redress Existing Inequities
The ruling also explicitly notes that race-conscious algorithms “may be appropriate and justified under certain circumstances, such as when used as a means to identify, evaluate, and address health disparities,” potentially repairing racial disparities and adding nuance to discussions about race and health.
Creation Of New Mechanisms To Support Impacted Patients
The proposed HHS rule will empower patients with new reporting pathways if their care is impacted by use of a discriminatory algorithm. Impacted individuals and entities have a private right of action to pursue legal recourse in federal court, a new private right of action and new options for self-advocacy. Additionally, the HHS Office of Civil Rights (OCR) will be equipped with resources to consider whether a covered entity has used an algorithm to discriminate. These investigations also allow HHS to represent the public interest at-large, reflecting the reality that one faulty algorithm may impact thousands of similarly impacted individuals.
Opportunities To Strengthen The Implementation
Convene Key Stakeholders To Reassess Existing Race-Based Guidelines
HHS has the opportunity to bring together medical organizations that publish race-based guidelines, topic experts, impacted patients, and other relevant stakeholders, and help establish a shared framework for reconsidering race-based guidelines. The authors cite the New York City Health Department’s Coalition to End Racism in Clinical Algorithms (CERCA) which coalesced stakeholders across public health, health systems, clinical research, health informatics, and social sciences to end race adjustment in three algorithms, monitor the impact on racial health inequities, and engage patients whose care was negatively impacted.
Fund Research To Quantify Harms, Implement Novel Solutions, and Assess Equity Impacts
The authors advocate that HHS, AHRQ, and other federal agencies conduct and fund clinical research that investigates and quantifies the harms of race-based algorithms and the potential benefits of their removal; community-based participatory research to ensure impacted patients and communities are involved in devising reparative solutions; and implementation science and quality improvement projects to deploy and reassess new algorithms.
Center Patient And Community Ideas In Determining Governance And Remediation Mechanisms
The authors prioritize a systems-based quality and safety approach emphasizing participatory action that includes marginalized patients and affected communities. They cite the Healing ARC intervention that addressed racial inequities in hospital admissions processes at Brigham & Women’s Hospital. They recommend that HHS develop a board of patient advocacy organizations, provider groups, and health systems leaders to help guide implementation, oversight, and restitution to speed the diffusion of novel innovations, and guide responses to formal complaints.