June 10,2025

Wyden-Grassley Report Exposes How Organ Procurement Organizations Game the System, Fail to Adequately Address Conflicts of Interest

Bipartisan investigation finds OPOs routinely abuse key loophole to boost recertification numbers, lack consistent framework to resolve conflicts of interest

Washington, D.C. – Senator Ron Wyden (D-Ore.), ranking member of the Senate Finance Committee, and Senator Chuck Grassley (R-Iowa), a senior member and former chairman of the Senate Finance Committee, released the results of their bipartisan investigation into nonprofit Organ Procurement Organizations (OPO), which are responsible for obtaining donated organs for transplant and research in the United States. 

The senators’ staff report reveals additional transparency is needed to strengthen the integrity of the organ procurement network and ensure the health and safety of organ donors and recipients. The investigation confirms the senators’ long-standing concerns, outlining examples of abuse to boost performance ratings and inadequate efforts by OPOs to identify and resolve conflicts of interest.  

Building on their nearly two decades of work to bring accountability to the organ donation system, Grassley and Wyden launched their investigation in the 118th Congress. As of 2024, 170 million Americans are registered organ donors. Since 1988, nearly 1.1 million life-saving transplants in the U.S. have been made possible from more than a half-million organ donors.  

“Americans expect the national organ transplant system to be fair and efficient so as many patients as possible receive the life-saving donation they need,” Wyden said. “Organ procurement organizations are a key link in this chain, and this investigation demonstrates there’s still more work to be done to improve the system. I look forward to building on our work to make the organ procurement network accountable and successful on behalf of American families who are counting on a transplant.”

“As millions of American families know first-hand, the organ donation system is a matter of life and death," Grassley said. "It’s critical to restore integrity to this system and to strengthen the public’s trust in it. Our investigation uncovered clear examples of OPOs exploiting a loophole in direct opposition to congressional intent. We also uncovered OPOs’ failure to clearly and effectively address conflicts of interest. Together, we are working to ensure the stewardship of precious organs is transparent, accountable and effective in order to save lives,” 

Full text of the investigative report and records can be found HERE.   

In the course of its investigation, staff reviewed internal research protocols and conflicts of interest documents produced by seventeen OPOs, including One Legacy, Donor Alliance, LifeQuest Organ Recovery Services, Indiana Donor Network, Kentucky Organ Donor Affiliates, Mid-America Transplant, New Jersey Organ and Tissue Sharing Network, LifeBanc, Lifeline of Ohio, Texas Organ Sharing Alliance, LifeCenter Organ Donor Network, Midwest Transplant Network, Versiti Wisconsin, LifeShare Network, Gift of Life Donor Program, Tennessee Donor Services and New Mexico Donor Services. 

Pancreata Loophole:

The Centers for Medicare & Medicaid Services (CMS) can re-certify OPOs if they meet certain standards. However, CMS has never decertified an OPO, allowing organizations to face little-to-no consequences for underperformance. To enhance accountability, CMS released a final rule in 2020 to update OPOs’ performance metrics. 

The rule created a loophole allowing pancreata recovered for research to be counted toward recertification, without clear verification the organs were actually used to advance research. Since the CMS rule was finalized five years ago, pancreata recovered for research by OPOs has increased more than four-fold, without a matching increase in researchers’ demand. 

Grassley and Wyden have sounded the alarm on the pancreata loophole for over three years, beginning with an April 2022 letter to then-Health & Human Services (HHS) Secretary Becerra and CMS Administrator Brooks-LaSure. 

The investigation also found serious concerns regarding OPOs’ relationships with third-party research clearinghouses and biobanks. After handing over procured pancreata to third party research arrangements, OPOs had little-to-no ability to verify the organs were utilized for research or that the research conducted was appropriate. OPOs surveyed by the senators reported an 850% increase in pancreata recovered for research without reporting a clear and corresponding research benefit. 

This undermines HHS oversight and allows underperforming OPOs to inflate their performance at the cost of critically ill patients. The loophole directly violates congressional intent, including the Pancreatic Islet Cell Transplantation Act of 2004.  

Conflicts of Interest:

Grassley and Wyden asked eight OPOs to disclose their conflicts of interest policies. Their investigation found CMS does not require uniform conflict of interest policies and procedures, which caused key differences between conflict of interest definitions, as well as who is covered under conflict of interest policies. 

Despite overwhelming evidence OPOs should address allegations of conflicting business and financial relationships, the Organ Procurement and Transplantation Network (OPTN) is not required to collect details on financial relationships, board member compensation or affiliated businesses. The investigation also found that OPTN and its former sole contractor, the United Network for Organ Sharing (UNOS), failed to act following formal complaints about financial conflicts of interest. 

Recommendations:

  1. CMS should clarify the requirements and expectations of OPOs reporting pancreata to be counted toward certification or recertification, to ensure OPOs are following the law and congressional intent.
  2. CMS should further clarify OPO conflict of interest policies to make clear that OPO governing boards and medical advisory boards, as well as CMS surveyors, monitor actual and potential conflicts.
  3. OPOs should clearly define policy coverage, scope of conflicts and disclosure procedures.
  4. OPOs should ensure board involvement, oversight and recording.  

Background: 

Grassley and Wyden have long sounded the alarm regarding conflicts of interest within the transplant system. In 2020, they wrote to HHS saying, “OPOs have greater financial incentives to focus more on tissue recovery compared to their incentives to recover lifesaving organs.”   

A 2022 Senate Finance Committee hearing and staff report highlighted a 2012 case involving the Alabama Organ Center (AOC) and its Executive Director who, according to a whistleblower complaint, participated in a “money laundering” scheme and violated AOC’s own “Standard Operating Procedure.” Following multiple apparent financial conflicts between OPOs and outside entities, Grassley and Wyden sent a letter in 2023 requesting answers on certain OPOs’ financial interests and business relationships.   

Grassley and Wyden are also the authors of bipartisan Securing the U.S. Organ Procurement and Transplantation Network Act, which marked the first reforms to the U.S. organ donation system in nearly 40 years. 

###