What does the data mean and how can it be used?
Previously we have spoken about the importance of maintaining compliance and having an effective pre-transplant evaluation process to manage the influx of patients from your successful outreach program. Once patients are transplanted you must be persistent in your diligence to ensure successful outcomes. Sometimes, despite optimal efforts, you may experience bad outcomes. If these unfavorable outcomes reach a certain threshold, regulatory agencies will scrutinize your program. Our next series of blogs will discuss the triggers that bring your program under scrutiny, the preliminary inquiries that are made, your options and the transplant System Improvement Agreement (SIA) process.
While a complaint could trigger a program review by UNOS (United Network for Organ Sharing) or CMS (Centers for Medicare and Medicaid Services), typically a review is triggered when there is a failure to meet certain pre-defined metrics. In terms of program assessment by the Membership and Professional Standards Committee (MPSC) of UNOS , it is important to remember that CMS has no role in the review process by MPSC. MPSC will request and review data analyzed by SRTR (Scientific Registry of Transplant Recipients) and from the OPTN (Organ Procurement and Transplantation Network) and identify programs for review from this analysis.
CMS relies primarily upon metrics for data submission, clinical experience or outcome requirements as outlined in Title 42 of the Code of Federal Regulations Part 482. To assess for data submission requirements, CMS will check to see that a transplant center has submitted to the OPTN, no later than 90 days after the due date established, at least 95% of the required data submissions on all transplants (deceased and living donor) performed over the 3-year approval period. Examples of required data submissions include, but are not limited to, submission of the appropriate OPTN forms for transplant candidate registration, transplant beneficiary registration and follow-up, and living donor registration and follow-up. The clinical experience outcome is generally met for all organs by performing 10 transplants in a 12 month period.
In terms of outcomes, CMS will review observed outcomes for all transplants performed at a center, including outcomes for living donor transplants if applicable, during the time period under review in the most recent SRTR center-specific report, and compare them to expected outcomes based on patient characteristics and risk stratification. CMS will consider a center's patient and graft survival rates to be unacceptable if:
- A center's observed patient survival rate or observed graft survival rate is lower than its expected patient survival rate and graft survival rate; and
- All three of the following thresholds are crossed over:
- The one-sided p-value is less than 0.05,
- The number of observed events (patient deaths or graft failures) minus the number of expected events is greater than 3, and
- The number of observed events divided by the number of expected events is greater than 1.5.
Should either regulatory body feel that further information is needed, they will contact the program with specific questions to be answered. In our next blog post, we will discuss key considerations for programs under UNOS and CMS review.
If you missed the live webinar, click below to view a recording of 5 Ingredients for a Successful Transplant Evaluation Process.
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.