Transplant Program Inactivation

2065 – Transplant Program Inactivation (Rev. 227; Issued: 12-13-24; Effective: 12-13-24; Implementation: 12-13-24) A transplant program may voluntarily declare an “Inactive Status” with CMS and may remain inactive and retain its Medicare approval for a period not to exceed 12 consecutive calendar months. See §488.61(d). Transplant programs that have declared inactive status are not receiving organ offers and/or performing transplants. Transplant programs must notify their waitlist patients of any inactivation or plan to inactivate their program as this affects their ability to receive a transplant. See §482.102(c) for more information. The program must provide written notification to its SA (on behalf of CMS) of the anticipated inactivity period as required at §482.74(a)(3). Notification to the SA and to the potential recipients must occur prior to the start of any planned inactivity period. During its inactivity period, the program must continue to comply with all Medicare CoPs. Once the SA receives notice of the transplant program’s intent to inactivate, a letter or electronic communication should be sent acknowledging receipt of the notification, ensuring the transplant program is aware of its responsibility to notify the SA when the inactivation ends, and that the voluntary inactivation may be no longer than 12 consecutive calendar months for the program to retain its approval. The SA should enter the transplant program’s inactivation start date in the provider details table of the national surveyor database. Routine surveys or complaint investigations will continue and should not be delayed based on a transplant program’s “Inactive Status.” Prior to going on-site for a re-approval survey, the survey team should determine if the program has had any voluntary inactivation since the last survey. If so, confirm during the survey that patients on the program’s waitlist were notified of the inactivation and that assistance was provided as discussed above. If during a survey it is determined that the transplant program implemented a voluntary inactivation but did not notify CMS (through the SA), a deficiency should be cited for §482.74(a)(3). If a surveyor finds that patients were not notified properly of inactivation or were not provided requested assistance, a deficiency should be cited for §482.102(c)(3). Notification to patients is expected to occur within 30 calendar days of the planned inactivation. Documentation of the notification may be evidenced in the patient’s medical record or a separate record maintained by the program. The SA must monitor all inactive transplant programs to ensure that the inactivation does not exceed the 12-month limitation. Once the program reaches its 11th month of voluntary inactivation, the SA should contact the program again to inquire as to the intentions of the program. A model letter for transplant program notification can be found in the SOM, Chapter 9: Exhibit 357. Once a transplant program voluntarily withdraws or is terminated following their inactive period, they must apply for initial approval and meet all applicable CoPs, including the data submission, clinical experience, and outcome requirements at 482.80.