UNOS fires back at defamatory statements that it has acted unlawfully

September 13, 2024 at 16:54 PM EDT

--News Direct--

The United Network for Organ Sharing (UNOS) is a private non-profit organization focused on saving lives. Its mission is to help patients and their families who are in desperate need of organ donation. But some members of the donation and transplant community continue to malign and defame UNOS, accusing our organization of unlawful behavior.

It must stop.

UNOS calls for truth and condemns defamation

At a hearing of the House Energy and Commerce Committee’s Oversight Subcommittee on Sept. 11 to discuss HRSA’s implementation of the Organ Procurement and Transplantation Network (OPTN) reform law, several witnesses made false statements under oath alleging violations of the law by UNOS while the non-profit served as OPTN. These individuals were able to produce no evidence of their claims, because it does not exist.

To be clear: UNOS has never engaged in any unlawful behavior. Any statement to the contrary is outrageous and actionable in court.

UNOS has been the international leader in organ donation and transplant for decades, and anyone who questions our motivations or accuses UNOS of unlawful activity is just plain wrong.

Here are some of the statements that imply or outright accuse UNOS of criminal behavior, and here’s our responses:

Statement: UNOS is a monopoly, and that monopoly has meant that patients don’t receive the care they need, and that the donation and transplantation system is corrupt. (Greg Segal, co-founder of Organize, and Dr. Seth Karp, former OPTN Board Member and OPTN Membership and Professional Standards Committee (MPSC) Member)

False. While witnesses used the term “monopoly” to characterize UNOS’ contract role, the characterization is false. The fact that there has only ever been a single OPTN contractor is because the law –not UNOS — said there could only be one OPTN contractor. Since the OPTN’s inception, HRSA has issued requests for proposals for a single organization to operate the network. UNOS submitted a bid proposal at each opportunity to compete. HRSA awarded the OPTN contract to UNOS in 1986, 1987, 1990, 1993, 1996, 2000, 2005, and 2018 HRSA, not UNOS, structures the OPTN contract and the bid process. Use of the term “monopoly” suggests that there is (or should be) a “market” for organ donation and transplant in America – a position with which UNOS strongly disagrees.

Statement: UNOS retaliates against whistleblowers, and engaged in rewarding and incentivizing whistleblower retaliation. (Greg Segal)

False. The individual who recited these false facts, while declining to produce any evidence in support, has never served on or volunteered with the OPTN, never worked within an OPTN member transplant program, and never worked within an organ procurement organization. He has, further, never served in any transplant and donation oversight role with HHS. Nonetheless, he stated under oath that whistleblower complaints were repeatedly and inexplicably brought to him regarding UNOS (while in its capacity as OPTN) because all complainants were afraid to report to OPTN, and that he promptly referred the complaints to law enforcement and government authorities to conduct further investigations.<p>There is no record of any such complaints, no record of any allegations against UNOS (whistleblower or otherwise) that were referred to law enforcement by Greg Segal, nor any follow-up investigation of UNOS/OPTN by law enforcement or government authorities, nor any request for UNOS’ cooperation in investigation of an OPTN member because of whistleblower complaints brought forth by Segal to law enforcement or HHS. UNOS is aware of no such record, complaint, or incident in the past four decades it has held the OPTN contract.

UNOS adheres to whistleblower protection laws and does not tolerate, or engage in, retaliation against whistleblowers.

Let’s also take a look at some key assertions from the subcommittee hearing - and what the real story is.

The following are among statements made on Sept. 11, 2024, at the House Energy and Commerce Committee’s Oversight Subcommittee hearing titled “A Year Removed: Oversight of Securing the U.S. Organ Procurement and Transplantation Network Act Implementation.”

The United Network for Organ Sharing (UNOS), whose leadership was not invited to participate in the hearing, has been the sole contractor for the OPTN for decades.

To set the record straight and correct some false information, UNOS is fact-checking statements made during the hearing.

Statement: Instead of reporting serious allegations of Medicare fraud, patient safety concerns, and bribery to the OPTN, whistleblowers reported these allegations to a private citizen who does not have oversight authority or the capacity to investigate these claims. (Greg Segal, co-founder of Organize)

If true, such allegations must be reported to applicable government authorities and law enforcement for further investigation.

Statement: The OPTN contract has recently been opened for competitive bidding “for the first time since the enactment of the OPTN.” (Opening statement of the hearing)

False. Every OPTN contract bid, including the initial solicitation in 1986, has been competitive. In each prior bid, UNOS was selected by HRSA to serve as the OPTN contractor after submitting responsive proposals. Until 2024, the OPTN contracts issued by HRSA were always single-vendor contracts. Starting in 2024, the government’s new model involves a multi-vendor approach, where the work of the OPTN is divided across multiple vendors. UNOS welcomes this new arrangement by which the OPTN contracting process includes more competition.

Statement: The OPTN, and/or individual OPOs, have been complicit or negligent in circumstances where potential donors have shown signs of life. (Segal)

False. In any situation involving deceased donation, the medical staff of the hospital make independent clinical determinations as to whether death has occurred or is imminent, according with the hospital’s own policy and applicable state laws or regulation. Organ recovery will not occur until death has been declared by the medical staff at the hospital. Neither OPO staff nor transplant professionals are involved in the determination of death. In the rare occasion that the clinical situation of a potential donor changes prior to a death declaration, all involved donation and transplant clinicians will immediately cease their activity and allow the hospital to provide supportive care as appropriate.

OPOs must adhere to a complex framework of rules and regulations generated by CMS, the OPTN, and the states in which they operate. Any potential violations of OPTN policies or bylaws that are reported to the OPTN are investigated by the OPTN’s Membership & Professional Standards Committee (MPSC), a committee on which HRSA representatives serve.

Statement: Previous OPTN Boards of Directors were “selected” by UNOS in a non-transparent process. (Dr. Seth Karp, surgeon-in-chief of Vanderbilt University Medical Center)

False. UNOS’s role, as the OPTN Contractor, is to administer the OPTN’s nomination process for the Board. UNOS does not select the board members. Rather, each OPTN board member is elected by the entire OPTN membership, via a process that is described in a detailed plan posted to the OPTN website and overseen by HRSA. In February 2024, reflecting the HRSA modernization principles, the current OPTN Board, whose terms began July 1, was elected by the OPTN membership, and not a single person who was elected to the OPTN Board simultaneously serves on the UNOS Board. Furthermore, the OPTN Board of Directors is now independent of the OPTN contractor and will be supported in the future by a new contractor that will manage future nomination processes and will not have any responsibility for OPTN operations.

Statement: Board and committee volunteers are “industry insiders” and have inherent conflicts of interest with their institution or professional organization. (Karp and Segal)

More context needed. This year alone, there are more than 1,000 distinct unpaid volunteers serving on the OPTN board and committees. Any individual bringing clinical or professional expertise to volunteer service on the Board or a committee will likely have relationships with a transplant hospital, an OPO, a histocompatibility lab, and/or clinical or professional societies relating to their discipline. This expertise is in fact key to making informed decisions that affect the national donation and transplant system, and it is specifically required by federal law and regulation regarding the OPTN Board composition. Notably, when Congress amended NOTA in 2023, it did not remove the composition provisions for the board, thus retaining the requirement that the OPTN Board be comprised of “representatives of organ procurement organizations…transplant centers, voluntary health associations, and the general public.” If Congress did not intend for these so-called “industry professionals” to be on the OPTN Board, it would have stricken that requirement from NOTA when it were amending other aspects of the law.

The OPTN has had in place for many years a conflict of interest policy to allow its volunteer leaders to disclose potential conflicts and recuse themselves from making decisions that pose a direct conflict. OPTN Board members are also required to sign an attestation at the beginning of each term, confirming that “My advice and opinions will be the result of my own independent judgment, and I will not take into consideration any responsibilities I have to any other organization while I fulfill my responsibilities as a director on the OPTN Board.” Additional steps taken under the HRSA modernization initiative, such as having a separate OPTN Board and a new code of conduct, should further strengthen the measures already in place to enable these volunteers to contribute in a fair and transparent manner.

Statement: UNOS has lobbied aggressively against reform and has made contract transitions as difficult as possible. (Segal)

False. UNOS has led efforts to improve the system, which are identified in the UNOS Action Agenda. In collaboration with stakeholders and government officials, UNOS established its independent corporate Board of Directors on March 30, secured language in the Federal Aviation Administration (FAA) reauthorization to ensure organs can travel above wing instead of as cargo to ensure safe handling and care, and educated policymakers about the need to ensure OPTN has the authority to collect pre-waitlist data on patients to understand and address barriers to transplantation. UNOS has called for a federal tracking system for organs, increased patient empowerment tools to support patients’ choices regarding their transplantation care, and improvements to hospitals’ donor referral processes to organ procurement organizations. UNOS performs this advocacy consistent with our mission and outside of our work or funding as the OPTN contractor. UNOS has repeatedly stated its support for HRSA’s OPTN Modernization Initiative and has actively lobbied for Congress to fully fund the President’s Fiscal Year (FY) 2025 budget request to support implementation.

As there has never been a transition of OPTN work to a new contractor, it is categorically untrue that UNOS has made contract transitions as difficult as possible. UNOS will work collaboratively with other OPTN contractors and transition work as determined by HRSA’s contract awards.

Statement: UNOS and the federal government lose organs that have been donated for transplant. (several speakers)

False. There are many organizations involved in transporting organs. Organ procurement organizations (OPOs) and transplant programs handle arrangements, scheduling, and coordination. The Organ Center, operated by UNOS for the OPTN, assists OPOs and transplant hospitals in making arrangements for the transportation of donated organs if requested. UNOS is not primarily responsible for transporting organs and HRSA has not required a federal tracking system, although UNOS has requested HRSA implement one. Further, outside of the requirements and funding of the OPTN contract, UNOS has developed an organ tracking system to assist in tackling this problem.

Furthermore, the OPTN only has purview for whole organs for transplant. The heart example shared at the hearing was about a research organ which is under FDA’s authority.

Statement: Some members of the UNOS board also sit on the OPTN board. (Chair Morgan Griffith)

False. UNOS established a new seven-person board effective on March 30, 2024. There is no overlap in the membership of the UNOS board and the OPTN board.

Statement: The OPTN Board President had something more important to do than testify (Greg Segal, in response to following statement from Rep. Armstrong: “[Rich Formica] refused to testify today, right?” during questioning on new OPTN whistleblower policy)

More context needed. The OPTN Board President is a practicing physician who was informed of the hearing with little notice.

About UNOS

United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant.