title: Potential Implications of Recent and Proposed Changes in the Regulatory Oversight of Solid Organ Transplantation in the United States.
abstract: 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.
authors.affiliation: Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, Minneapolis, MN.|Department of Medicine, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.
authors.forename: B L
authors.initials: BL
authors.lastname: Kasiske
authors.affiliation: Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, Minneapolis, MN.
authors.forename: N
authors.initials: N
authors.lastname: Salkowski
authors.affiliation: Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, Minneapolis, MN.
authors.forename: A
authors.initials: A
authors.lastname: Wey
authors.affiliation: Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, Minneapolis, MN.|Department of Medicine, Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.|Department of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.
authors.forename: A K
authors.initials: AK
authors.lastname: Israni
authors.affiliation: Scientific Registry of Transplant Recipients, Minneapolis Medical Research Foundation, Minneapolis, MN.|Department of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN.
authors.forename: J J
authors.initials: JJ
authors.lastname: Snyder
mesh_terms: D014487:Centers for Medicare and Medicaid Services, U.S.; D006801:Humans; D006278:Medicare; D016377:Organ Transplantation / Q000331:legislation & jurisprudence / Q000592:standards*; D012042:Registries / Q000706:statistics & numerical data*; D009927:Tissue and Organ Procurement / Q000331:legislation & jurisprudence / Q000592:standards*; D066027:Transplant Recipients; D014481:United States
keywords: Organ Procurement and Transplantation Network (OPTN); Scientific Registry for Transplant Recipients (SRTR); editorial/personal viewpoint; organ transplantation in general