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.

Measuring Transplant Center Performance: the Goals Are Not Controversial but the Methods and Consequences Can Be

“…Early analysis raised several concerns about the new criteria including more review of programs with little underperformance, potential escape from review in programs with greater underperformance, and greater review of programs may increase number of centers developing risk averse behaviors. [7]…”

“…The 1.5 threshold is retained as a “standard” level deficiency requiring QAPI efforts, but does not immediately put Medicare participation at risk or require filing of a corrective action plan. [7] Prior to this in the fall of 2014, the MPSC adopted new flagging criteria based on Bayesian methods. Under these criteria, programs with a 75% probability of the hazard ratio (HR) for survival exceeding 1.2 or a 10% probability of the HR >2.5 would be flagged.…”

“…[11] A recent analysis demonstrated the newly proposed MPSC criteria performed worse in terms of sensitivity, specificity, positive predictive value, and negative predictive value at all performance levels considered. [7] The total number of MPSC reviews overall increased, and programs with greater underperformance could potentially escape review.…”

The Collaborative Innovation and Improvement Network (COIIN): Effect on donor yield, waitlist mortality, transplant rates, and offer acceptance

“…COIIN was not a randomized study, and programs were selected with regard to potentially informative characteristics, including not being under active OPTN MPSC review. Because programs under CMS review decreased transplant volume, and CMS reviews only a subset of programs reviewed by the MPSC, COIIN likely selected programs on a factor related to transplant rate and offer acceptance. As a sensitivity analysis, we estimated the difference in transplant rate between candidates in COIIN and matched controls not in COIIN, matching on candidate characteristics, baseline program‐specific transplant rate, and initial program‐specific posttransplant evaluation (see Supplementary Materials for details).…”

“…The Organ Procurement and Transplantation Network (OPTN) and Centers for Medicare & Medicaid Services (CMS) monitor 1‐year posttransplant outcomes for quality assurance . Although posttransplant outcomes may improve after CMS regulatory intervention, regulatory review may limit access to transplant due to an incorrect perception that performing transplants with high predicted risk leads to poor posttransplant evaluations .…”