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Transplant - Laws and Regulations

This page provides basic information about the applicable laws and regulations for organ transplant programs.  Medicare Conditions of Participation for organ transplant programs were established on March 30, 2007, and became effective on June 28, 2007.
A transplant program is defined as a component within a transplant hospital that provides transplantation of a particular type of organ.

Types of organ transplant programs:

  • Heart
  • Lung
  • Heart/lung - The program must be located in a hospital with and existing Medicare-approved heart and Medicare-approved lung program.
  • Liver
  • Intestine - The program must be located in a hospital with a Medicare-approved liver program. This program includes multivisceral and combined liver-intestine transplants
  • Kidney; and
  • Pancreas - The program must be located in a hospital with a Medicare-approved kidney program. This program includes combined kidney/pancreas transplants.

All organ transplant programs must be located in a hospital that has a Medicare provider agreement.  In addition to meeting the transplant Conditions of Participation, the transplant program must also comply with the hospital Conditions of Participation (specified in 42 CFR 482.1 through 482.57).