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Quality, Safety & Oversight- Guidance to Laws & Regulations Transplant

Guidance for organ transplant programs providing basic information about the applicable laws and regulations.

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: July 19, 2017

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
  • 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).

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.