How to Navigate a Transplant System Improvement Agreement Process #3: The System Improvement Agreement

The System Improvement Agreement (SIA)

In our previous post, we discussed what happens when your program receives a letter from either the United Network for Organ Sharing (UNOS) or the Center for Medicare and Medicaid Services (CMS) and your program's initial response.  Today we will focus on what happens if CMS does not accept your mitigating factors application. 

If CMS does not accept the mitigating factor application, they will offer the transplant program and hospital the opportunity to enter into a Systems Improvement Agreement, or SIA.  CMS will outline a series of steps that the program must complete in order to satisfactorily fulfill the agreement and avoid desertification. The agreement allows the organization and hospital leadership to affect large scale organizational and cultural changes that will facilitate compliance without the constraint of a 23 day desertification period.  By entering into the SIA, the organization agrees to retain responsibility for maintaining compliance with CMS requirements and also waives its rights to administratively or judicially challenge the findings cited in the Statement of Deficiencies.  The hospital assumes responsibility for all costs for the SIA which frequently run between $500,000 and $1,000,000 including the costs of the consultants as well as the internal resources that need to be expended towards the SIA effort.  Additional costs will be incurred to implement and sustain the changes necessary to bring the program into compliance.  The alternative, however, is to lose Medicare certification, which for the vast majority of transplant programs would mean certain closure. 

The SIA agreement will outline a series of activities that must be undertaken by the program and a time-frame for completion.  First, the program must engage the services of outside expert consultants, such as Strategic Illuminations, LLC to assist in the SIA process.  An independent review team (IPRT) comprised of an organ-specific transplant surgeon and transplant physician, transplant administrator, social worker, coordinator and Quality Assessment Process Improvement (QAPI) expert must perform an onsite evaluation of the program.  The IPRT team will provide a verbal report of their findings to CMS as well as a comprehensive written report to the transplant program and hospital.  An onsite consultant, separate from the IPRT team,  must be retained to be onsite a number of days per month, the frequency determined by CMS but typically numbering 6-8 days a month.  An action plan needs to be developed based upon the IPRT findings with the assistance of the onsite consultant and implemented during the term of the SIA.  Monthly calls will be held with CMS to report on progress and to review certain deliverables that the program must prepare and submit.  In addition to addressing the necessary issues identified by the IPRT, the program will need to perform a series of tasks that CMS will outline in the SIA agreement.  These will include a notification letter to the program's patients informing them of the SIA, creation of a patient assistance fund for those patients desiring to transfer to another program, a staffing analysis, a focused review of certain policies relevant to the deficiencies necessitating the SIA, a detailed data analysis to demonstrate proficiency in data management to be incorporated into ongoing  QAPI efforts,  identification of quality indicators and evidence of QAPI activities.  Any graft failures or patient deaths occurring within a year from transplant must be reported immediately to CMS and a root cause analysis performed.

In our next blog, we will discuss some of the individual components of the SIA in more detail. 


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.