How to Navigate a Transplant System Improvement Agreement Process Blog #6: Required CMS Deliverables

Today, we will continue our discussion about the System Improvement Agreement (SIA) and the various deliverables that will be required by the Centers for Medicare and Medicaid Services (CMS) to emerge successfully. 

CMS will request that any patient death or graft loss within one year of transplant be reported to their offices within 5 business days of the hospital’s knowledge of the event and that a root cause analysis (RCA) be performed to identify potentially remediable causal factors. In some cases, the Independent Peer Review Team may suggest that the program gain additional experience in performing root cause analyses by evaluating other events as well, for example waiting list deaths within a year of listing. 

Such a recommendation usually occurs because the IPRT determined that the root cause analyses performed by the program on their graft losses and patient deaths lacked depth and sophistication.  Such an exercise may also help identify deficiencies in the program’s evaluation process or listing criteria.  In addition to the notification of any additional patient deaths or graft losses and the RCA, the program will be required to provide quarterly outcome reports throughout the duration of the SIA. 

Should the program alter their selection criteria during the SIA for any reason, they must notify CMS of such changes.  In addition, CMS will expect any pertinent data analysis that led to the change be submitted as well as what changes are expected from the change.  Although the natural tendency of a program under an SIA is to reduce their risk profile, this can actually be counter-productive by effectively raising the program’s expected outcomes.  All of the reports that we have described will be reviewed on the monthly update calls with CMS during which the program will review the previous month’s activities and deliverables and CMS will have the opportunity to ask for clarification on any questions that they have. 

The last deliverable that will be required is a summary document of the SIA experience focusing on programmatic challenges as well as lessons learned during the course of the mitigating factor and SIA process.  While some programs use this as an opportunity to provide feedback on the perceived burdens of the SIA process, it is best to focus the presentation in a positive light and highlight the positive effects the program has experienced and the challenges it has faced and overcome during the process. 

Once submitted, there will be one final call with CMS that will include senior transplant leadership from CMS.  When preparing for this call, it is important to review the IPRT findings that were reported to CMS following the IPRT visit as these points, if overlooked, will be queried by the CMS staff to be sure that the concerns of the peer review team, have been appropriately addressed over the course of the SIA process. 

Congratulations! At the end of the call CMS will inform you that you have been successful and will be released from the SIA.  Once released, you can expect your F-QAPI visit within the next 6-12 months. 

We hope that these blogs have helped to demystify the SIA process.  Having an experienced team, such as Strategic Illuminations, LLC, that understands all aspects of the process and the potential effects that it can have on your program will lead to successful navigation of the SIA process.  We hope that you will be able to join us in our upcoming webinar to further discuss the SIA process. 

If you’re going to 24th Annual UNOS Transplant Management Forum, we’d love to meet you in person and understand your strategy for pre- and post-transplant health information workflows.  Sign up for one of our sessions to see our intelligent clinical data extraction automatically capture actionable data from outside lab results and referral packets! 


About the Author: Dr. John Daller, MD, PhD, FACS

As a former Director of several transplant programs, Dr. Daller has expertise in all aspects of transplant program management, as well as hospital program development including clinical, regulatory, business and administrative leadership via his company Strategic Illuminations. He consults in the area of medical legal review, due diligence and scientific evaluations, as well as utilization review via Daller Consulting. He is also Chief Medical Officer of Concordia Valsource, LLC which provides consultative services to developing biopharmaceutical companies and to Venture Capital groups investing in the health and life sciences. Previously, Dr. Daller was Vice President for Medical Programs in the Transplant Business Unit of Genzyme Corporation.