Previously we have discussed in general what happens when your center comes under regulatory scrutiny and what you can expect. Today, we will begin to look in greater detail at what a System Improvement Agreement (SIA) entails, the items that the hospital commits to fulfill and some strategies for addressing them.
One of the first things that the hospital will be asked to do is to notify all of the patients on their waiting list that the program is entering into an SIA with CMS. Specifically, the letter must address the fact that the transplant program does not meet Medicare's minimum standards for the Conditions of Participation they are cited for and state the relevant observed and expected outcome measures. The letter must clearly state that the program is under an SIA agreement with CMS and, that if the hospital fails to meet the terms of the agreement, Medicare may terminate coverage for transplants of that organ type at the center. The letter must inform patients that they have the option of either dual listing at another transplant center or transferring their listing to another hospital and that your center will assist them in that endeavor.
Furthermore, should patients incur expenses in doing so; your program needs to notify them that you have established a fund that will provide them with financial assistance for associated out-of-pocket expenses. These may include co-insurance, co-payments and all other out-of-pocket medical costs necessary for tests, and other reasonable costs, in order to be wait-listed at the other transplant hospital.
The letter must be submitted to and approved by CMS prior to mailing it to your wait-list. Your hospital must identify two transplant facilities that meet Medicare criteria to which to refer your patients and to assist patients in transferring to the hospital they choose. This includes facilitating the referral process and ensuring timely exchange of information, services and medical records to the receiving hospital. As you can imagine, this requirement can decimate a program's list and subsequently lead to substantial financial cost if not handled appropriately.
The hospital will be required to contract with an independent transplant consultant to work onsite to provide technical guidance, professional insight, training, and constructive feedback on an ongoing basis to assist the hospital to improve patient and graft outcomes, to assist the program in fulfilling the terms of the agreement, and to implement recommendations for programmatic changes. This consultant should be engaged as soon as possible to assist with the independent peer review team's (IPRT) visit. CMS will determine how much time the consultant must be involved but typically it is 8 days a month with 75% of the time being onsite Monday through Friday during regular work times.
In terms of qualifications, the consultant must have demonstrated experience in managing and/or evaluating successful Transplant Program(s) of the type under review, including related quality assessment performance improvement activities, activities related to all phases of transplant care and performance by a multidisciplinary team. He/she must have sufficient autonomy to facilitate open and unbiased information exchange with various program and institutional areas, as well as CMS, and must have designated senior management liaisons in the hospital and the transplant program with which the consultant regularly communicates and coordinates the activities described in the agreement.
Throughout the process, it is important to recognize that there are proscribed time frames within which tasks need to be completed and reports provided to CMS.
In our next blog, we will talk about the IPRT team visit including their responsibilities, scheduling issues, the development of an action plan and how having experienced oversight of the process can ensure success.
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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.