This page provides basic information about organ transplant programs. The CMS Conditions of Participation (CoP)s for organ transplant programs were established on March, 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 to include; heart, lung, liver, kidney, pancreas or intestine.
All organ transplant programs must be located in a hospital that has a Medicare provider agreement. In addition to meeting the transplant CoPs, the transplant program must also comply with the hospital CoPs (specified in 42 CFR §482.1 through §482.57).
Brief description of document(s):
The final rule set forth CoPs for data submission, clinical experience, outcome and process requirements. The requirements focus on an organ transplant program's ability to perform successful transplants and deliver quality patient care as evidenced by outcomes and sound policies and procedures. The CoPs include requirements to protect the health and safety of both transplant recipients and living donors.
Notification to CMS of Significant Changes to a Transplant Program
Transplant programs must notify the CMS immediately of significant changes to the program that could affect its compliance with Medicare's requirements (required under 42 CFR §482.74). The term "immediately" is considered to be within 7 business days of the change occurring. These changes include: changes in key staff members and inactivation by the transplant program. The CMS must be notified of significant staff changes to include, changes to the transplant program’s “primary surgeon” or “primary physician” as designated by the OPTN. The CMS must be notified when a transplant program intends to inactivate its program. The CMS must receive notification of a transplant program’s voluntary inactivation with Medicare at least 30 days prior to the planned inactivation date. Please notify the CMS by email at QSOG_TransplantTeam@cms.hhs.gov.
Evaluation of compliance with Medicare's Requirements
The evaluation of a transplant program's compliance with Medicare requirements involves several steps. CMS will obtain data from UNOS, the contractor for the Organ Procurement Transplantation Network's (OPTN), to provide background and determine compliance with the program's OPTN membership, submission of forms to OPTN, clinical experience (volume), and outcomes, as applicable. CMS will share this information with either the State Survey Agency or CMS' Contractor (depending upon the provider's location) to incorporate into their onsite evaluation of compliance with the Medicare CoPs.
Process for Requesting Consideration of Mitigating Factors in CMS' Determination of Medicare Approval of Organ Transplant Centers
A transplant program may request that CMS consider mitigating factors in the initial approval of a transplant program that does not meet the data submission, clinical experience, or outcome requirements for §482.80. §488.61 describes three general areas that will be reviewed in determining whether or not a program can be approved based on mitigating factors. These areas include (but are not limited to):
1. The extent to which outcome measures are met or exceeded;
2. The availability of Medicare-approved transplant centers in the area; and
3. Extenuating circumstances that may have a temporary effect on meeting the CoPs;
4. Program improvements that substantially address root causes of graft failures or patient deaths, that have been implemented and institutionalized on a sustainable basis, and that are supported by outcomes more recent than the latest available SRTR report, for which there is a sufficient post-transplant patient and graft survival period and a sufficient number of transplants such that CMS finds that the program demonstrates present-day compliance with the requirements at §482.80(c)(2)(ii)(C) or §482.82(c)(2)(ii)(C) of this chapter;
5. Whether the program has made extensive use of innovative transplantation practices relative to other transplant programs, such as a high rate of transplantation of individuals who are highly sensitized or children who have undergone a Fontan procedure compared to most other transplant programs, where CMS finds that the innovative practices are supported by evidence-based published research literature or nationally recognized standards or Institution Review Board (IRB) approvals, and the SRTR risk-adjustment methodology does not take the relevant key factors into consideration;
6. Whether the program's performance, based on the OPTN method of calculating patient and graft survival, is within the OPTN's.
All information necessary for consideration must be received within 120 calendar days of CMS’ written notification for a deficiency due to noncompliance at §482.80. The complete mitigating factors application should be sent electronically to CMS Baltimore at QSOG_TransplantTeam@cms.hhs.gov.
See Mitigating Factors Checklist for the content requirements for the application.
Consideration of Mitigating Factors - Updated 05/21/2020 (PDF)