Transplant Programs

State Operations Manual (SOM) Chapter 2 Certification Process

SOM Appendix X Survey Protocol and Interpretive Guidelines for Organ Transplant Programs

SOM Appendix Z Emergency Preparedness for All Provider and Certified Provider Types

To voluntarily become a Medicare-certified provider, you will need to complete the following steps and submit the documents electronically to LARA-BSCSupport@michigan.gov, unless otherwise noted in the instructions:

• Complete the Provider Enrollment Application (CMS-855A) and submit it to Medicare Administrative Contractor (MAC). The MAC will provide you a recommendation letter once the initial review is complete.
• The hospital in which the transplant program is located must also simultaneously submit a revised CMS-855A form to its Medicare Administrative Contractor (MAC) to indicate the addition of a service.
• The transplant program can apply for and be approved for both an adult and pediatric transplant program for the same organ type, or it can apply to be approved separately. If approved separately, they will be surveyed separately.
• Membership in the Organ Procurement and Transplantation Network (OPTN) by the transplant hospital is required.
• An initial survey by the Bureau of Survey and Certification will be scheduled upon notification from the MAC that the revised CMS-855A has been approved.
• Currently, CMS has prioritized initial surveys as lower priority tier work. Following the guidance of the CMS Mission and Priority Document, there may be an extended period before the initial survey can be completed.

Once all of the above documents have been received, your application will be deemed complete, and the Bureau of Survey and Certification will review and forward the documents to the CMS Chicago location for final determination and issuance of the Medicare provider number.

Please note: this process can take up to 30-60 days from the date of receipt by the CMS Chicago location.

• A transplant program may request consideration of mitigating factors in the initial approval and reapproval 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 state on the CMS-2567, which is submitted to the Bureau of Survey and Certification, that it will apply for mitigating factors on the facility’s Plan of Correction (POC) for noncompliance with data submission, clinical experience, or outcomes noncompliance.
  • Upon receipt of a POC, that includes an intent to apply for mitigating factors by the provider, the Bureau of Survey and Certification will provide a copy of the POC to CMS mailbox (OSOG_TransplantTeam.cms.hhs.gov) and the Bureau of Survey and Certification will refer the provider to 488.61(f) for the list of information that should be submitted for the mitigating factors application (see the Mitigating Factors Application Checklist).
  • All information necessary for consideration of mitigating factors must be received within 120 calendar days of receipt of the formal written notification of noncompliance at 482.80 or 482.82.