How to Navigate a Transplant System Improvement Agreement Process #2: You Received a Letter in the Mail, Now What?

There's more than one letter?

If your letter is from the United Network for Organ Sharing (UNOS), it will most likely be from the UNOS Membership and Professional Standards Committee (MPSC) after it performed a review of your center's data.  The MPSC will have flagged your program due to either functional inactivity (a fa ilure to perform a transplant every 3 months, or in the case of pancreas, one every 6 months) or due to outcomes that are below expected results.  If the issue is a volume issue, you will be asked to document how your center is trying to increase the activity as well as what are your surgeons and physicians are doing to maintain their skills in the operative and medical management of the organs in question.  You will also be asked to justify the turn down codes for the organ offers you have received.  Should the issue be one of outcomes, you will be asked to provide synopses of the cases in question and include an analysis of what led to the below expected outcome results.  In addition, you will likely receive a Transplant Outcomes questionnaire that probes the experience of the surgeons, transplant physicians and administrator at the program as well as the extent of institutional support and commitment both from hospital leadership as well as from ancillary services and multi-disciplinary participation.  An activity log will be provided to assess how many patients are evaluated, listed and transplanted at the center.  Depending upon the situation, MPSC may request follow-up reviews to monitor the program's progress. 

Should you receive a letter from the Centers for Medicare and Medicaid Services (CMS), the focus will likely be on a failure to meet one of the Conditions of Participation, most likely related to either graft or patient survival relative to expected results.  Under the authority of 42 CFR §488.61, a transplant program may request that CMS consider mitigating factors in the re-approval process.  There are three general areas that will be reviewed to determine whether a program can be approved based upon mitigating factors.  These areas include, but are not limited to, the extent to which the outcome measures are met or exceeded, the availability of Medicare-approved transplant centers in the geographic area or extenuating circumstances that may have a temporary effect on the program's ability to meet the Conditions of Participation. 

Once CMS receives the request for the consideration of mitigating factors and the response to any additional information requested, they will typically schedule a conference call with the hospital to discuss the results of their review of the application.  The request for approval under mitigating circumstances must be made within 10 days of the receipt of the notification letter and must state which Condition(s) of Participation were not met that the center is requesting CMS review for consideration of mitigating factors. Within 30 days of the notification letter, the center will provide information explaining the rationale for the mitigating factor request, supporting evidence that the program wishes CMS to review in support of the mitigating factors application, internal program improvements that demonstrate the program's efforts to track and analyze the causative factors of the non-compliance, the specific findings of the analysis and the specific changes that were implemented to correct the deficiencies and any outcome data for the prior three years if the request is for outcome deficiencies.  Finally, if the program has been discussed or reviewed by the OPTN, this information should be included as well. 

In our next blog, we will discuss what happens when the mitigating factors application is denied and the program is offered the opportunity to enter into a System Improvement Agreement with CMS.

To learn about how to ensure a successful transplant evaluation process, click on the button below watch this on-demand webinar presented by Dr. John Daller, President of Strategic Illuminations, a transplant program consultancy and former transplant program director and Gary Sigle, the Transplant Administrator for St. Luke's Hospital in Kansas City.

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.