Licensing and Regulatory Affairs
All survey activity for approval and re-approval of Medicare transplant programs was transitioned to the State Survey Agencies on January 1, 2019.
A transplant program must be located within a hospital that has a Medicare provider agreement. A transplant program seeking initial approval by CMS should notify the State Agency (SA) of its request. The transplant program must complete and submit to the SA the form Attachment A - Required information for all Applications for Medicare Approval of Transplant Programs. The hospital in which the applicant is located must also simultaneously submit a revised CMS-855A (CMS-855A) form to its Medicare Administrative Contractor (MAC), indicating the request for the addition of a practice location. An initial survey by the SA will be scheduled upon notification from the MAC that the revised CMS-855A has been approved.
Approved transplant programs will be surveyed by the SA for re-approval at a 5-year survey interval.
Transplant programs must notify the State Agency immediately (defined as within 7 business days of the change occurring) of significant changes to the program that could affect its compliance with Medicare requirements (required under 42 CFR 482.74). These changes include but are not limited to, changes in key staff members such as the primary transplant surgeon, as designated to the OPTN and/or the primary transplant physician, as designated to the OPTN; and any inactivation by the transplant program. Such notifications can be emailed to BCHS-CMSCertification@michigan.gov.
A transplant program may request consideration of mitigating factors in the initial approval and re-approval of a transplant program that does not meet the Conditions of Participation (CoP) at 482.80 or 482.82. Mitigating factors will not be considered in situations of immediate jeopardy.
The transplant program must submit a CMS-2567 plan of correction to the SA that specifically states the applicant is requesting consideration of mitigating factors for non-compliance with data submission, clinical experience or outcomes noncompliance. The SA will notify the program of the need to submit a mitigating factors application summary in letter format, along with information described on Attachment G: Mitigating Factors Application Checklist.
Michigan Department of Licensing & Regulatory Affairs
Bureau of Community and Health Systems
Federal Survey & Certification
611 W. Ottawa Street
PO Box 30664
Lansing, MI 48909