Biden-Era Regulation Faces Legal Challenge as Trump-Backed Group Demands Repeal

Trump-aligned lawfare group America First Legal (AFL) has petitioned two federal health agencies to repeal a Biden-era regulation they claim unfairly prioritizes race over medical need in kidney transplant allocation. The regulation, part of the Increasing Organ Transplant Access (IOTA) Model, was designed to promote equity in organ transplantation by incentivizing hospitals to reduce health disparities. Critics argue the rule violates civil rights laws by embedding a ‘DEI lens’ into transplant decision-making, asserting it promotes race-based preferences and undermines established medical criteria.

The IOTA Model, introduced by the Health and Human Services Department (HHS) and the Centers for Medicare and Medicaid Services (CMS), scores hospitals across three domains—achievement, efficiency, and quality—for kidney organ transplantation. Based on these scores, hospitals receive financial incentives, face penalties, or neither, though the equity component was initially part of the regulation but was later removed. Instead, the rule’s equity agenda was embedded through a ‘voluntary’ health equity plan that encourages hospitals to identify health disparities and set goals to reduce them.

AFL argues that the rule’s design, despite its voluntary nature, pressures hospitals to consider race and identity in transplant decisions. The group claims the regulation violates Title VI of the Civil Rights Act, Section 1557 of the Affordable Care Act, and the equal protection clause, while also exceeding CMS’ statutory authority under the Social Security Act. AFL attorney Megan Redshaw stated that the rule treats race as a substitute for medical judgment and risks condemning patients to death on waitlists based on immutable traits rather than clinical need.

The regulation was part of broader efforts by the Biden administration to address systemic inequities in healthcare, including an executive order requiring federal agencies to conduct equity assessments. CMS had earlier requested public input on how to advance equity in organ transplantation, citing higher rates of kidney failure among Black and Latino patients compared to White Americans. Despite these efforts, critics like AFL argue that the rule represents an overreach and a departure from evidence-based medicine, advocating for a return to policies grounded in medical criteria rather than identity-based preferences.

The nation’s organ transplant system has also recently faced scrutiny over premature organ retrievals while patients are still alive, prompting reforms by the Health and Human Services Department (HHS) following a federal investigation into troubling practices by a major organ procurement organization. AFL’s legal challenge highlights the broader ideological battle over how to address healthcare inequities, with opponents arguing that the IOTA Model undermines medical objectivity and risks exacerbating existing disparities in the transplant system.