In early October 2022, several state Attorneys General, including California, New York, Massachusetts, and the District of Columbia, submitted a comment letter expressing support for a Notice of Proposed Rulemaking published by the Department of Health and Human Services (HHS), aimed at lessening discrimination in healthcare.
HHS Proposed Rule
The comment was submitted in response to an August 4, 2022, proposed rule issued by HHS outlining several changes to the agency’s regulations under the Affordable Care Act, including a proposal to hold first time covered entities’ liable when using discriminatory algorithms in clinical decision-making. Under the relevant part of the Affordable Care Act, any healthcare entity or organization that receives any federal funds (i.e., Medicare or Medicaid) cannot discriminate on race, color, national origin, age, disability, or sex in health programs or activities.
In the proposed rule, HHS noted that clinical algorithms tend to include sociodemographic variables and measures of health care utilization, often using race and ethnicity as explicit input variables and adjusting the algorithm’s output on the basis of a patient’s race or ethnicity.
One such example is the tools many clinics use to evaluate kidney function. Many tools use an estimation of the eGFR that includes race as a factor, limited to a “black/non-black” option. The eGFR adjusts the score for Black patients as they “have been associated with higher levels of blood creatinine than white people.” By adjusting the eGFR for Black patients, their kidneys seem 16% healthier than white patients’ kidneys, though Black Americans are about four times as likely to have kidney failure than white Americans and make up 35% of people on dialysis. HHS notes that this practice “reduces the number of Black people placed on transplant lists and referred for kidney disease management, nephrology specialists, and dialysis planning.”
State Attorney General Support
The group of state Attorneys General called the proposal “welcome,” noting that it “appropriately puts covered entities on notice of the relevance of Section 1557 to clinical algorithms, and is likely to increase the healthcare sector’s attention and investment into clinical review and auditing of these types of processes.” They note that discrimination “is increasingly prevalent, yet, based on the States’ investigatory experiences, it is generally not transparent to consumers, and can be poorly understood even by providers.” They further noted (and agreed) that HHS believes the proposal does not actually represent any new prohibitions, but instead acts as a “clarification and communication” regarding a specific form of discrimination for covered entities.
They “urge” HHS to finalize the Proposed Rule to “ensur[e] that Section 1557’s robust civil rights protections apply” and make clear that the HHS “regulation addressing algorithmic discrimination by covered entities is intended to establish a floor, not a ceiling, for the protection of healthcare consumers.”
California Request for Information
California Attorney General Rob Bonta seems to have taken one step further, issuing letters to multiple hospitals across the state requesting information about how they are identifying and addressing racial and ethnic disparities in their own commercial decision-making tools. Bonta’s office is seeking a wide range of information in response to the letters, including information on all commercially available or purchased decision-making tools, products, software systems, or algorithmic methodologies currently in use at each hospital for different functions, including clinical decision support, population health management, care management, utilization management, operational management, and payment management. He is also seeking the name and/or contact information of the people who are responsible for evaluating the purpose and use of the tools to ensure they do not have a disparate impact based on race or other protected characteristics.