Background: In mid-2007, the Centers for Medicare and Medicaid Services (CMS) implemented Conditions of Participation for organ transplant programs, under which programs not attaining specified standards risk loss of certification. We evaluated outcomes improvements and quantified volume changes among adult kidney transplant programs that applied for consideration of mitigating factors (MF) related to outcomes citations and were surveyed by CMS through 31 Dec, 2009.

Methods: Volumes and outcomes were assessed at 12-month intervals pre and post CMS survey date (data sources: Medicare claims, SRTR, SSDMF). Programs that voluntarily withdrew from Medicare were excluded. Expected one-year graft survival was calculated based on a Cox proportional hazards model, fitted to national kidney transplant data, from which the probability of survival was estimated for each graft, given the individual transplant characteristics.

Results: Of 15 MF programs identified, volume declined in 8 (volume 1-2y post-survey was <80% of volume 2-1y pre-survey). Aggregate volume in this group fell from 525 kidney transplants 2-1 years pre-survey, to 248 transplants 1-2y post-survey. Excess graft failures also declined from 34.8 in the 2-1y pre-survey, to 1.1 graft failures above expected at 1-2y post-survey. Among the 7 programs that maintained/increased volume, 400 vs 467 kidney transplants were performed at 2-1y pre- and 1-2y post-survey, respectively. Excess graft failures fell from 15.3 to 3.0 over this interval.

Conclusions: Among kidney transplant programs entering MF through Dec 2009, volume was equally likely to decrease or be maintained/increase. For both groups, excess observed graft failures as compared to case-mix adjusted expected graft failures during the first year post-transplant declined. Potential contributory factors include quality improvements mandated under the regulations, modifications in donor/recipient selection, and changes in payer and referral patterns.

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