Transplant Program Application Requirements
- Transplant programs that were previously Medicare-approved (prior to June 28, 2007) were required to apply for continued participation to CMS by December 26, 2007.
- Transplant programs that are interested in seeking Medicare-approval are required to apply using the process described in the Downloads section below.
Notification to CMS of Significant Changes to a Transplant Program
Transplant programs must notify 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, a decrease in the number of transplants performed, a decrease in the program's survival rates, the termination of an agreement between the hospital and the Organ Procurement Organization, and inactivation by the transplant program. A detailed description of the notification requirements can be found in the Downloads section below.
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), and from the University of Michigan 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 Conditions of Participation.
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 and re-approval of a transplant program that does not meet one or more Conditions of Participation. The regulation 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):
- The extent to which outcome measures are met or exceeded;
- The availability of Medicare-approved transplant centers in the area; and
- Extenuating circumstances that may have a temporary effect on meeting the Conditions of Participation.
See Download for how to apply for mitigating factors.
University of Michigan Kidney Epidemiology and Cost Center (UMKECC) is contracted with Centers for Medicare & Medicaid Services (CMS) to provide research and analysis of transplant and organ procurement data from the Scientific Registry of Transplant Recipients (SRTR) and to identify practice changes. UMKECC also assists CMS with oversight and administration of Survey and Certification activities. Specifically, UMKECC:
- Provides SRTR and other data reports to CMS on an ongoing basis in a format prescribed by CMS to facilitate the oversight of transplant programs.
- Conducts in-depth analyses on the methodology and risk-adjustment factors used by the Scientific Registry of Transplant Recipients for evidence-based decision making.
- Conducts research on the broader changes to transplantation and organ procurement using a variety of quantitative and qualitative research methodologies.
See Downloads section below for recent UMKECC research.
- Medicare-Approved Transplant Programs - Updated 9/09/14 [PDF, 504KB]
- Medicare-Approved Transplant Programs - Updated 9/09/14 [ZIP, 469KB]
- Consideration of Mitigating Factors [PDF, 187KB]
- Items Requested from Transplant Programs During the Onsite Survey [PDF, 30KB]
- Requirements for Transplant Programs to Notify CMS Immediately of Significant Changes [PDF, 20KB]
- 12/14/07 Update - Clarification Regarding Application and Approval Process for Transplant Programs Serving Primarily Pediatric or Adult Patients [PDF, 32KB]
- Application Information [PDF, 48KB]
- UMKECC Research [PDF, 2MB]
- Page last Modified: 09/09/2014 9:59 AM
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