Quality, Safety & Oversight - Certification & Compliance for Transplant programs

This page provides basic information about solid organ transplant programs. 

Special Requirements for Transplant Programs

The Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoP) for solid organ transplant programs were established in March 2007 and became effective on June 28, 2007. To be approved by Medicare, transplant programs must meet the requirements specified at §482.72 through §482.104. A transplant program is located in a Medicare-approved hospital and provides transplantation services for the following types of solid organs: heart, lung, liver, kidney, pancreas, or intestine. 

Note: an intestinal transplant program must be located in a hospital with a Medicare-approved liver program to perform intestinal transplants. A pancreas transplant program must be located in a hospital with a Medicare-approved kidney program to perform pancreas transplants. 

In addition to meeting the transplant CoPs, the transplant program must comply with the hospital CoPs (specified in 42 CFR §482.1 through §482.57).

State Operations Manual

The CMS State Operations Manual (SOM) is a federal document that provides guidance to state survey agencies and healthcare providers on the interpretation and enforcement of CMS regulations, outlining the survey and certification process, and the standards healthcare organizations must meet to participate in Medicare. The SOM serves as a reference for healthcare institutions to find policies, procedures, and regulations in preparation for surveys, and it guides state survey agency representatives through compliance audits. 

Appendix X of the State Operations Manual contains the interpretive guidance and survey procedures for transplant programs. See Related Links below for quick access to Appendix X for transplant programs. 

Data Submission, Clinical Experience, and Outcome Requirements for Initial Approval

Transplant programs must meet requirements for data submission, clinical experience, and outcomes at §482.80 to receive their initial Medicare approval or may seek mitigating factors review for noncompliance associated with this requirement in accordance with §488.61. 

Provisions under §488.61 authorize CMS to consider mitigating factors when determining approval for a transplant program that has not met the data submission, clinical experience, or outcome requirements if the program submits a formal, written request for such a review.

If the applicant does not wish to apply for mitigating factors consideration for non-compliance at §482.80, the initial application will be denied, and the provider will be notified of the denial in writing.  If the applicant is determined to be out of compliance with any Condition of Participation other than §482.80, the initial application should be denied and all usual certification processes for denials should be followed.

List of Medicare-Approved Transplant Programs

The list of Medicare-approved transplant programs is available on CMS’ Quality, Certification & Oversight Reports (QCOR) website. 

1. Go to: https://qcor.cms.gov/main.jsp
2. Select “Hospitals” from the list of Providers & Suppliers.
3. Select “Approved Transplant Programs List” from the Provider Reports. This will open an Excel spreadsheet that contains certification information for all Medicare-certified transplant programs, organized by State.

If you have any issues or questions pertaining to the list of Medicare-approved transplant programs, please send issues /questions to CMS QSOG_TransplantTeam @cms.hhs.gov.

All other data requests must be filed using Freedom of Information Act (FOIA) request methods. See Related Links for instructions on submitting a FOIA request.