This page provides basic information about Medicare approval for organ transplant programs, and includes links applicable laws, regulations, compliance information, and a listing of currently approved 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
• Heart/lung – The program must be located in a hospital with and existing Medicare-approved heart and Medicare-approved lung program.
• 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).

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): 

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 Conditions of Participation.

See the Downloads section below for details.

Downloads
Consideration of Mitigating Factors - Added 9/5/08 (PDF, 75 KB) Items Requested from Transplant Programs During the Onsite Survey (PDF, 34 KB) Medicare-Approved Transplant Programs - Updated 8/28/08 (PDF, 586 KB) Medicare-Approved Transplant Programs - Updated 8/28/08 (Zip, 696 KB) Requirements for Transplant Programs to Notify CMS Immediately of Significant Changes - Revised 2/26/08 (PDF, 29 KB) Final Rule: Hospital Conditions of Participation: Requirements for Approval and Re-approval of Transplant Centers to Perform Organ Transplants (PDF, 467 KB) Transplant Programs Covered by the Regulation (PDF, 27 KB) Information Required on All Applications for Approval (PDF, 30 KB) 12/14/07 Update - Clarification Regarding Application and Approval Process for Transplant Programs Serving Primarily Pediatric or Adult Patients (PDF, 36 KB) Organ Transplant Application Update (PDF, 10KB) Where to Submit Applications (PDF, 27 KB)
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Page Last Modified: 09/05/2008 3:20:41 PM
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