Clinical Experience Requirements for Transplant Centers
The U.S. Centers for Medicare and Medicaid Services (CMS) has issues a memorandum outlining the Transplant Center Medicare Conditions of Participation (CoPs) at 42 CFR 482.80(b) - Clinical Experience. These requirements state that in order for a transplant program to be considered for initial Medicare certification it must generally perform 10 transplants over a 12 month period.
The CoPs at 42 CFR 482.82(b) Clinical Experience require that in order for a certified transplant program to be considered for re-approval it must generally perform an average of 10 transplants per year during the prior three years.
Clinical Experience: Determining the Level of Non-Compliance
Initial Approval of Transplant Programs under §482.80(b):
If the transplant program has not performed at least eight transplants in the past 12 months it may not be certified for Medicare participation. If the program has performed at least eight but less than 10 transplants in that time period, a deficiency should be cited at the Standard level. The program may still be Medicare certified with a Standard level citation for Clinical Experience if an acceptable plan of correction is received and all CoPs are in compliance.
Re-approval of Transplant Programs under §482.82(b):
If the transplant program has performed an average of less than 10 transplants per year over the re-approval period (three years), a deficiency should be cited at the Standard level. The program may be re-approved with a Standard level citation for Clinical Experience if an acceptable plan of correction is received and all CoPs are in compliance.
The Memorandum explains that the determination of Condition level non-compliance is made based upon the extent of noncompliance with the Standards of the Condition. A finding of non-compliance for the Standard Clinical Experience alone with no other non-compliance within the Condition would generally not result in a Condition level non-compliance for §482.80 or §482.82.
Although a certified transplant program may choose to go “inactive” for a certain period of time, the program must still meet the Clinical Experience requirements without consideration of the inactivity period.
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