Transplant Hospitals

Transplant HospitalThis page provides basic information about organ transplant programs. The CMS Conditions of Participation (CoP)s for organ transplant programs were established in 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 including; 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).

• Regulations
  • Conditions of Participation for Transplant Centers
  • Condition of Participation: Emergency Preparedness for Transplant Centers
  • Survey Protocols and Interpretive Guidelines

Initial Applications

• Effective January 1, 2019, transplant programs seeking to participate in the Medicare program must submit a request for Medicare approval to the applicable State Survey Agency (LDH, Health Standards Section). The request must include the information listed on the Transplant Application Checklist.
• The hospital in which the transplant center is located must submit a revised CMS-855A to its Medicare Administrative Contractor (MAC) to indicate the addition of a service.
• Once the MAC notifies the SA of its approval of the revised CMS-855A, a survey may be scheduled.

Submission of Changes in Information and Inactivation

Transplant programs must notify the CMS (via the state survey agency) 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.

• Changes in Key Staff - The Primary Transplant Surgeon or Primary Transplant Physician, as designated to the Organ Procurement Transplantation Network
• Inactivation by the Transplant 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.
  • A transplant program may choose to voluntarily inactivate its program. If they do so, they must notify the patients on their waitlist and CMS of the inactivation.  The program must assist the patients if they want to transfer to another program as a result of the inactivation without loss of wait time.  A voluntary inactivation may not exceed 12 consecutive calendar months (§488.61(e))

Mitigation Factors Procedure

• 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 §482.80 or §482.82 (see Conditions of Participation for Transplant Centers). 488.61 describes three general areas that will be reviewed in determining whether or not a program can be approved based on mitigating factors. 
  • Mitigating Factors Application Checklist

Contact

Debby Franklin
Debby.Franklin@la.gov
225-342-2205