Transplant Centers: Clinical Experience Requirements

• Citing Non-Compliance with Clinical Experience: Transplant programs are required per 42 CFR 482.80 (b) to generally perform 10 transplants within the past 12 months for initial certification with Medicare. Programs applying for initial Medicare certification that performed at least eight but less than 10 transplants in the previous 12 months should be cited at the Standard level. The program may still be certified with an acceptable plan of correction for clinical experience requirements if all Conditions of Participation (CoPs) are in compliance.
• For re-approval: Programs are required per 42 CFR 482.82 (b) to perform an average of 10 transplants per year during the prior three years. Programs not meeting this average should be cited at the Standard level, and the program must submit an acceptable plan of correction. The program may be reapproved if all CoPs are in compliance. Voluntary program inactivity does not affect these evaluation periods.