BACKGROUND: On June 28, 2007, CMS introduced new Conditions of Participation (CoP) for Transplant Centers- the impact of these regulations on adult patients at high risk for renal transplantation (HRR) has not been widely reported.

METHODS: We used an incident cohort of patients from the USRDS who underwent renal transplantation between January 2004 and October 2009. We defined HRR as having one or more of the following : age ≥55 years, African American (AA), diabetic, peak PRA ≥80%, previous renal transplantation. Chi-square test was used for statistical associations.

RESULTS: The percentage of high risk transplant recipients rose after the introduction of the new CoP (80.0% before vs. 81.8% after; P=0.0001). Transplantation of diabetic recipients decreased (41.6% vs. 40.0%; P=0.002), but increased for other high risk groups: age ≥55 years (45.4% vs. 48.7% ; P=0.0001), AA (31.3% vs. 32.6% ; P=0.012), peak PRA ≥80% (10.6% vs. 12.7% ; P=0.0001), except for no changes in retransplantions (12.8% vs. 12.4%r; P=0.192). From 2004, yearly transplants per 100,000 patient years increased in both high risk and non-high risk groups; then declined from 2007 and 2008, respectively. AA were the only high risk group with increased adjusted yearly transplant rates. Patient and graft survival at 1 year post-transplantation increased after the introduction of the new CoP with mortality at 1 year 5.3% before and 4.0% after (P=0.0001), and graft failure at 1 year 7.6% before and 6.4% after (P=0.0001).

CONCLUSIONS: After the introduction of the 2007 CoP, transplant centers significantly changed their criteria for which HRR receives a renal transplant.

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