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WASHINGTON, D.C. – Today, America First Legal (AFL) launched a new investigation into the outside influence that shaped the Biden Administration’s Increasing Organ Transplant Access (IOTA) Model. AFL filed three Freedom of Information Act (FOIA) requests with the Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and the Health Resources and Services Administration (HRSA) to expose the role of third-party entities in designing and advancing the policy.
The IOTA Model, developed under the Biden Administration, is a six-year mandatory program that took effect on July 1, 2025. It rewards transplant hospitals with payments for increasing transplant numbers, directly linking organ procurement to financial gain. This approach raises concerns about patient safety, ethical misconduct, and discrimination in organ allocation, and demands utmost transparency to preserve public trust in America’s organ transplant system.
Recent HHS findings from an HRSA-led investigation, released on July 21, 2025, exposed systemic ethical violations by Organ Procurement Organizations (OPOs). AFL is concerned that the same OPOs, along with nonprofits such as the United Network for Organ Sharing (UNOS), the Association of Organ Procurement Organizations (AOPO), and for-profit contractors, may have unduly influenced the IOTA Model—potentially exacerbating unethical practices and compromising the integrity of organ procurement.
AFL’s requests, covering records from January 1, 2021, to the present, seek to uncover:
All correspondence, emails, letters, and memoranda between agency personnel and third-party representatives regarding the IOTA Model’s development, drafting, or implementation. Meeting records, including agendas, minutes, notes, and summaries involving agency staff and third parties, where the IOTA Model was discussed. Submissions from third parties, such as reports, white papers, or policy proposals that influenced the model’s formulation or the final rule. Internal agency documents, drafts, memos, or briefs reflecting third-party recommendations or influence. Internal communications among agency personnel about the role of third parties in the IOTA Model’s development. Agency communications evaluating third-party input during the rulemaking process.
These filings underscore AFL’s commitment to promoting the rule of law, preventing government capture by special interests, and safeguarding individual rights under the U.S. Constitution. By making responsive records publicly available, AFL will empower citizens, scholars, and the media to scrutinize whether the IOTA Model was developed with integrity or outsourced to entities implicated in ethical scandals.
“Self-interested third parties should play no role in shaping America’s organ transplant policy. Where monetary incentives and penalties come into play, there must be utmost certainty that CMS developed the program without influence from entities with improper motives. Recent HHS findings regarding concerns over premature organ harvesting make our investigation all the more pressing. Our requests will help shine the light behind the Iron Curtain of the Biden Administration and provide transparency to the American people,” said Laura Stell, America First Legal Counsel.
Read the FOIA request for HHS here.
Read the FOIA request for HRSA here.
Read the FOIA request for CMS here.
Read more about our investigation here.
Learn more about AFL’s Merit-Based Medicine initiative here.
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