Transplant Program Application Requirements
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 and inactivation by the transplant program.
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.
- Survey & Certification - Guidance to Laws and Regulation - Opens in a new window
- Conditions for Coverage and Conditions of Participation - Transplant Centers - Opens in a new window
- Electronic Code of Federal Regulations - Transplant Conditions of Participation - Opens in a new window
- Transplant Approval Reapproval Mitigating Factors - Opens in a new window
- Emergency Preparedness for Transplant Programs - Opens in a new window
- CMS Survey & Certification Memos - Opens in a new window
- How to submit CMS FOIA request - Opens in a new window
- Page last Modified: 07/19/2017 11:21 AM
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