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WASHINGTON, D.C. – America First Legal (AFL) has filed a Rulemaking Petition urging the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) to repeal a Biden-era regulation that embeds race-conscious policies into America’s organ transplant system.
The Increasing Organ Transplant Access (IOTA) Model, which took effect on July 1, 2025, alters how transplant hospitals determine who receives a kidney during the transplant process. Instead of relying solely on clinical urgency and established medical criteria, the Biden Administration directed hospitals to factor race, ethnicity, and “equity” into allocation decisions—an outgrowth of the administration’s sweeping equity agenda aimed at confronting the “unbearable human costs of systemic racism.”
Under this model, select hospitals must operate within an equity-driven framework that pressures them to adopt race-conscious transplant policies. As part of the model, hospitals are encouraged to submit “Health Equity Plans” to CMS that:
Identify target “health disparities” based on race, ethnicity, or socioeconomic status. Develop “targeted strategies to close those gaps.” Conduct a “resource gap analysis” to reorient staffing, funding, and operational needs around equity goals. Establish performance measures designed to achieve predetermined racial and ethnic outcomes in transplant access.
Although CMS ultimately made Health Equity Plans “voluntary,” the agency embedded them inside a mandatory federal model that encourages hospitals to integrate race and identity into transplant decision-making. A federal rule cannot invite or normalize discrimination—not even under the guise of improving “equity.” With at least 67 of the 103 hospitals mandated to participate in the IOTA Model still engaging in DEI, the rule normalizes identity-based preferences in a system federal law requires to rely exclusively on “established medical criteria.”
According to CMS’s data, nearly 5,000 Americans die each year waiting for a kidney transplant. Rather than strengthening guardrails to ensure that organs are allocated to patients whose clinical need is greatest, the IOTA Model experiments with the demographic makeup of those who receive kidneys. In practice, this means a patient who urgently needs a kidney gets passed over in favor of someone who can wait longer simply because of their race.
Beyond its equity mandates, the IOTA Model pressures hospitals to pursue higher transplant volumes by awarding bonus payments to those that increase transplant numbers and penalizing those that perform fewer. Tying institutional revenue to transplant counts encourages aggressive procurement and transplant practices in a system already marred by ethical failures, oversight breakdowns, and documented patient-safety concerns.
“The IOTA Model is a leftover remnant of an unlawful equity agenda that encouraged hospitals to view lifesaving care through a DEI lens,” said Megan Redshaw, attorney for America First Legal. “Federal law requires that organ allocation be based on established medical criteria, not race or identity, and no rule should push hospitals to pursue transplant volume while layering race-based pressures onto a system already plagued by ethical failures.”
The IOTA Model Final Rule violates Title VI of the Civil Rights Act, Section 1557 of the Affordable Care Act, the Equal Protection Clause, and binding U.S. Supreme Court precedent. It also exceeds CMS’s statutory authority under the Social Security Act and is arbitrary and capricious under the Administrative Procedure Act. Congress never empowered CMS to redesign the Nation’s organ-allocation framework or to embed identity-based metrics into medical decisions that determine who receives lifesaving care.
AFL’s filing further notes that the IOTA Model conflicts with President Trump’s Executive Orders 14151 and 14173, which categorically prohibit the use of race, ethnicity, sex, or other immutable characteristics in federally funded programs and require agencies to terminate all DEI-based mandates. The continued implementation of the IOTA Model is irreconcilable with those governing directives.
“The Biden Administration built this kidney transplant policy on the false premise that fairness requires discrimination,” Redshaw said. “This rule treats race as a substitute for medical judgment, and it risks condemning patients to die on waitlists based on immutable traits instead of clinical need. Every American deserves equal treatment under the law, especially when life and death are at stake.”
AFL’s petition calls on HHS and CMS to immediately repeal the IOTA Model Final Rule, withdraw all related guidance, and restore race-neutral, merit-based standards in organ transplantation.
Read AFL’s petition here.
Read more about our investigation here.
Learn more about AFL’s Merit-Based Medicine initiative here.
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