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Questions of accountability and transparency in the US organ donation and transplantation system

Nature Medicine volume 28, pages 1517–1518 (2022)Cite this article

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To the Editor — The US federal government has made it clear, in both the National Organ Transplant Act (PL 98-507) and the Final Rule (42 CFR 121), which established the regulatory framework for the structure and operation of the Organ Procurement and Transplantation Network (OPTN), that the transplant system requires increased transparency, accountability, and policy that is evidence based and equitable1,2,3. To illustrate this, Senate Finance Committee Chairman Chuck Grassley (R-IA), Ranking Member Ron Wyden (D-Ore.), and Senators Todd Young (R-IN.) and Ben Cardin (D-MD.) sent the United Network for Organ Sharing (UNOS) a request for information and data in February 2020, after “recent reports of lapses in patient safety, misuse of taxpayer dollars, and tens of thousands of organs going unrecovered or not transplanted”4 that call into question the adequacy of UNOS’ oversight of the country’s 57 organ-procurement organizations.

In 2021, Senate Finance Committee leaders Senators Grassley and Wyden subpoenaed UNOS, compelling the production of documents related to the committee’s investigation of organ-procurement organizations and potential false claims5 submitted to government benefit programs. In May 2021, a House of Representatives Oversight subcommittee began investigating allegations of fraud, waste and abuse in the transplant industry. Representative Raja Krishnamoorthi (D-IL), Chairman of the Subcommittee on Economic and Consumer Policy, and Representative Michael Cloud (R-TX), Ranking Member of the Subcommittee on Economic and Consumer Policy, held a virtual hearing to examine the transplant system.

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References

  1. Becker, Y. Curr. Transplant. Rep. https://doi.org/10.1007/s40472-022-00353-6 (2022).

  2. MacMurdo, M. G. & Sweet, S. C. Ann. Am. Thorac. Soc. 17, 795–799 (2020).

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  3. Department of Health and Human Services. National Archives Code of Federal Regulations https://www.ecfr.gov/current/title-42/chapter-I/subchapter-K/part-121 (accessed 19 April 2022).

  4. Grassley, C. E. et al. United States Senate Committee on Finance https://www.finance.senate.gov/imo/media/doc/2020-02-10%20Grassley,%20Wyden,%20Young,%20Cardin%20to%20UNOS%20(Information%20Request%20on%20Organ%20Transplant%20System).pdf (10, February 2020).

  5. Grassley, C. Chuck Grassley https://www.finance.senate.gov/ranking-members-news/grassley-wydensubpoena-the-united-network-for-organ-sharing-as-part-of-continued-investigation-into-us-organ-transplant-system (4 February 2021).

  6. Office of Congressional and Government Affairs. National Academies of Sciences, Medicine, and Engineering https://www.nationalacademies.org/ocga/public-laws/further-consolidated-appropriations-act-2020 (2019).

  7. National Research Council. https://doi.org/10.17226/26364 (The National Academies Press, 2022).

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Authors and Affiliations

  1. Department of Surgery, NYU Grossman School of Medicine, NYU Langone Health, New York, NY, USA

    Macey L. Levan, Samantha Klitenic, Allan Massie, Brendan Parent, Sommer Gentry & Dorry Segev

  2. Department of Population Health, NYU Grossman School of Medicine, New York, NY, USA

    Macey L. Levan, Allan Massie, Brendan Parent, Arthur Caplan, Sommer Gentry & Dorry Segev

Authors
  1. Macey L. Levan
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  2. Samantha Klitenic
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All authors contributed equally to this Correspondence.

Corresponding author

Correspondence to Macey L. Levan.

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Competing interests

D.S. was a member of the NASEM ad hoc committee that authored the report A Fairer and More Equitable, Cost-Effective, and Transparent System of Donor Organ Procurement, Allocation, and Distribution. M.L.L. and S.K. provided consultative services to NASEM to assist with the report. M.L.L. is a former member of the OPTN and UNOS board of directors.

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Levan, M.L., Klitenic, S., Massie, A. et al. Questions of accountability and transparency in the US organ donation and transplantation system. Nat Med 28, 1517–1518 (2022). https://doi.org/10.1038/s41591-022-01859-3

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