CMS SOM App. X, Tag X-033

To be considered for initial approval, an organ-specific transplant program must generally

perform 10 transplants over a 12-month period.

Guideline §482.80(b)

“Generally” means in all instances except where specifically exempted by the regulations.

A transplant program will not be considered for initial approval until it has performed a

minimum of eight transplants over a 12-month period at the time of its request for Medicare-approval. Kidney transplant programs must perform a minimum of three transplants before an

initial certification survey can be performed, as specified by §482.80(d)(5).

The following types of programs are subject to a clinical experience requirement of having

performed generally 10 transplants over a 12-month period for initial approval:

• Adult Heart-Only

• Adult Lung-Only

• Adult Liver

• Adult Intestinal and/or Multivisceral

For purposes of the clinical experience requirement, multi-organ transplantation will be included

as separate transplants for each organ. For example, a combined liver-kidney transplant will

account for one liver transplant and one kidney transplant.