Potential Implications of Recent and Proposed Changes in the Regulatory Oversight of Solid Organ Transplantation in the United States

B. L. Kasiske, N. Salkowski, A. Wey, A. K. Israni, J. J. Snyder

Research output: Contribution to journalArticlepeer-review

24 Scopus citations


Every 6 months, the Scientific Registry of Transplant Recipients (SRTR) publishes evaluations of every solid organ transplant program in the United States, including evaluations of 1-year patient and graft survival. The Centers for Medicare & Medicaid Services (CMS) and the Organ Procurement and Transplantation Network (OPTN) Membership and Professional Standards Committee (MPSC) use SRTR's 1-year evaluations for regulatory review of transplant programs. Concern has been growing that the regulatory scrutiny of transplant programs with lower-than-expected outcomes is harmful, causing programs to undertake fewer high-risk transplants and leading to unnecessary organ discards. As a result, CMS raised its threshold for a “Condition-Level Deficiency” designation of observed relative to expected 1-year graft or patient survival from 1.50 to 1.85. Exceeding this threshold in the current SRTR outcomes report and in one of the four previous reports leads to scrutiny that may result in loss of Medicare funding. For its part, OPTN is reviewing a proposal from the MPSC to also change its performance criteria thresholds for program review, to review programs with “substantive clinical differences.” We review the details and implications of these changes in transplant program oversight.

Original languageEnglish (US)
Pages (from-to)3371-3377
Number of pages7
JournalAmerican Journal of Transplantation
Issue number12
StatePublished - Dec 1 2016

Bibliographical note

Funding Information:
This work was conducted under the support of the Minneapolis Medical Research Foundation, contractor for the Scientific Registry of Transplant Recipients, as a deliverable under contract no. HHSH250201500009C (US Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation). As a US government?sponsored work, there are no restrictions on its use. The views expressed herein are those of the authors and not necessarily those of the US government. A.K.I. was partially supported by R01 HS 24527. The authors thank SRTR colleague Nan Booth, MSW, MPH, ELS, for manuscript editing.

Publisher Copyright:
Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

Copyright 2017 Elsevier B.V., All rights reserved.


  • Organ Procurement and Transplantation Network (OPTN)
  • Scientific Registry for Transplant Recipients (SRTR)
  • editorial/personal viewpoint
  • organ transplantation in general


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