Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
Legal Challenges Emerge Over Biden Administration’s Organ Transplant Policy
FIRST ON FOX: A legal group aligned with former President Trump is urging the federal government to repeal a regulation established during the Biden administration. This regulation, they allege, prioritizes organ transplantation based on race rather than medical need.
A coalition led by Stephen Miller, a former aide in the Trump White House, is targeting two of the government’s leading health agencies. They are petitioning the Department of Health and Human Services and the Centers for Medicare and Medicaid Services for immediate repeal of the Increasing Organ Transplant Access Model, commonly referred to as the IOTA Model.
Understanding the IOTA Model
The IOTA Model was designed to assess kidney organ transplantation at selected hospitals across three performance domains: achievement, efficiency, and quality. Compliance with this model can lead hospitals to receive financial incentives or face penalties depending on their performance metrics. Hospitals must participate in the model to be eligible for these incentives.
Although an initial proposal included a specific equity performance adjustment, that element was eliminated before the final rule was published. Instead, the regulation integrates a more subtle approach—encouraging hospitals to create a “voluntary” health equity plan. Mandatory participating hospitals are urged to define health disparities and develop metrics to evaluate their effectiveness in addressing those disparities.
Concerns Raised by America First Legal
America First Legal has labeled the regulation a potential invitation to discrimination disguised as a push for ‘equity.’ A press release from the organization stated, “A federal rule cannot invite or normalize discrimination—not even under the guise of improving ‘equity.’” They argue that while Health Equity Plans portion of the regulation is voluntary, its integration into a mandatory model could pressure hospitals to incorporate race into crucial transplant decisions.
The IOTA Model represents a significant shift within the organ transplant framework, evolving from previous pilot payment programs. It officially commenced on July 1, following its publication in the Federal Register on December 4.
Ongoing DEI Efforts Amid Controversy
Currently, 67 out of 103 hospitals involved in the IOTA Model remain actively engaged in diversity, equity, and inclusion initiatives. Critics, including America First Legal, claim that these efforts reinforce identity-based preferences in the country’s transplantation protocol.
Megan Redshaw, an attorney for America First Legal, argued that the IOTA Model is a remnant of a misguided equity agenda that complicates the transplantation system. “Federal law mandates organ allocation based on established medical criteria—not identity or race,” she stated. “No rule should pressure hospitals to prioritize transplant volume while introducing race-based considerations.”
The Backdrop of Biden’s Executive Order
Just after taking office in 2021, President Biden signed Executive Order 13985. This order mandated that federal agencies assess whether underserved communities encounter systemic obstacles in accessing federal programs. Agencies were also tasked with developing action plans to address these barriers.
In December 2021, the Centers for Medicare and Medicaid Services issued a public request for comments on how to enhance equity and mitigate disparities in organ transplantation. They cited alarming statistics reflecting the disproportionate rates of kidney failure among Black and Latino populations compared to their White counterparts.
Investigative Efforts by America First Legal
Supporters of the Trump administration have raised concerns about the participation of external groups in shaping the IOTA Model. America First Legal has filed Freedom of Information Act requests to investigate the Biden administration’s efforts to incorporate diversity initiatives into the organ transplant system.
One focal point of criticism involves modernization initiatives for the national organ transplant system, emphasizing enhanced equity and performance metrics alongside changes in how race and ethnicity data is classified for organ donors.
The Ethical Debate Over Organ Procurement
Recently, the national organ transplant system has faced scrutiny over accusations of prematurely initiating organ retrievals while patients were still alive or in improving health conditions. The Department of Health and Human Services released a statement in July addressing this issue, revealing plans for reform following alarming findings from a federal investigation into a major organ procurement organization.
America First Legal contends that the final IOTA Model rule violates several key legal standards, including Title VI of the Civil Rights Act and the Affordable Care Act’s Section 1557. They argue that the rule is beyond the statutory authority granted to the CMS and is
