Expanding the donor pool

Expanding the donor pool

By: David Axelrod, MD

The ever-expanding waiting list for deceased donor organs is the focus of several national efforts to improve access to transplant by decreasing organ discard. A recent report using UNOS data suggests that the organ discard rate increased remarkably from 5.1% in 1988 to nearly 19.2% in 2009. In 2015 alone, 3,159 kidneys were recovered but were not transplanted. While it is important to recognize that there are marked differences in the donor pool over this period, including greater recovery of older donors and donors with significant kidney dysfunction, it is also true that the current regulatory and financial environment reduces enthusiasm for the use of marginal donor organs. Acceptance of kidney allografts decreases markedly as the Kidney Donor Profile Index (KPDI) increases as shown in the figure from the OPTN/SRTR Annual Data Report annual report. Currently, more than 60% of donated kidneys with a KDPI >85 are discarded nationally, compared with < 20% of those with a KPDI < 85. While these organs are less than ideal for some patients, there are thousands of patients on the list who could benefit from these transplants.

Despite the clear benefits of transplant, many transplant programs remain concerned that expanding the use of high KDPI organs will negatively impact transplant center outcomes and financial performance. Transplant centers fear that despite the risk adjustment methodologies employed by the SRTR in calculating center outcomes, increased rates of graft loss from high KDPI organs will lead to citations for poor outcomes. An extensive data analysis prepared by the SRTR demonstrates that the use of marginal donors does not contribute to increased rates of citation by UNOS or Medicare (Snyder et al. 2016). However, centers continue to argue increasing transplants using these organs will result in loss of contracts and censure. It is important to acknowledge that the SRTR analysis focused specifically on the risk of a center being flagged for poor performance. It did not address the likelihood that a center would flip from a 4-star to a 2-star program using the new SRTR 5-tier risk system, nor the chance the center’s O:E ratio would change sufficiently to result in loss of private payer Center of Excellence status.

It is important to appreciate that the impact of the changes in risk adjusted outcomes related to the use of high KDPI organs is fundamentally dependent on how well programs do with high risk organs. Centers that do well with these organs can derive significant benefits, while centers that perform less well than the community can expect to have their outcomes appear worse. Because of the perceived risk of citation, however, these organs are often left unused. This problem has been compounded by required regional sharing for higher risk donor organs under the new kidney allocation system (KAS). The KAS system has been shown to increase ischemic times, exacerbate logistical complexity, and contribute to higher rates of discard following its implementation. Perhaps the higher rate of discard will be addressed soon though a modification in the allocation system; however, under KAS this issue of inefficiency is the current reality.

To address some of these concerns, the Board of Directors of UNOS has recently approved a change in the system of citation used by the MPSC. Under the revised rules, any center that is flagged for poor performance under current performance metrics will be re-evaluated after transplants using high risk donors (KPDI > 85) in high risk recipients (EPTS > 80) are excluded. If the center is then in compliance, the center will not be flagged. Furthermore, while not specifically stated, it appears that CMS will strongly consider these data in the decision not to find a center in violation of the Conditions of Participation. The use of these organs can also be used in a mitigating factors application if necessary. Thus, it appears that from the federal government standpoint, there is growing consensus that increasing rates of transplant is beneficial and should not predispose a center to regulatory risk. It is important to note, however, that the private payer networks have not agreed to change their practices. Furthermore, the SRTR has not been directed to produce different reports which exclude the population of high risk patients from public reporting. Therefore, centers are not fully “protected” by the new rules should their outcome with these high risk organs be significantly worse than national average performance.

HRSA has taken an additional step to further address the ongoing organ discard issue by developing and supporting the COIIN project (Collaborative Innovation and Improvement Network). COIIN brings together leading transplant programs to provide shared learning about the use of high risk organs. The COIIN program is also providing enhanced data feedback to centers to ensure that patients receiving these organs have function that is generally within expectation, while exempting participants from routine outcomes monitoring under UNOS. The goal of the project is to enhance the acceptance of high KDPI kidneys through processes and protocols that have demonstrable benefits (enhanced education, referring physician engagement, care protocols including outpatient dialysis post-transplant, and improved OR efficiency). Membership in COIIN has recently expanded to include more centers. It is important to note, that the collaborative will be monitoring 30-day rates of delayed graft function, primary non-function, and 1-year creatinine to identify early trends in poor performance. It will be important for the transplant community to review aggregated data once it is available.

The National Kidney Foundation also recently sponsored a consensus conference on decreasing organ discard rates. The NKF foundation produced recommendations for OPOs, transplant programs, and payers designed to remove barriers to organ recovery and acceptance. Among the proposed initiatives was a decreased reliance on allograft biopsy data (which has been shown to correlate poorly with outcomes), increased access to pulsatile perfusion, improved transplant center–OPO coordination, and consideration of payment reform to address the higher costs incurred by centers that utilize these organs. While the final report is still being prepared, the conference included representatives from the transplant community, CMS, third-party payers, and the OPOs. Equally important, the conference specifically sought out and included patient representatives to ensure that the focus of the conference remained on saving lives through organ donation and transplantation.

In the opinion of XynManagement, broader use of non-standard donor organs offers important opportunities for your transplant program. These organs can help your center to increase transplant volume, provide lifesaving therapy for patients with few other options, and, actually, protect your outcomes, if done properly. There are several Xyn tools that may help you do this. First, use the XynTrack tool to examine your center’s outcomes by KDPI strata. If your O:E for high KDPI organs is < 1 you are doing well and should seek to do more of these organs. If not, look at the grafts that fail or patients that died. What are the common themes? Can improved pre-transplant management mitigate these risks? Is there an opportunity to improve OR efficiency? Are there ways to develop closer post-transplant follow-up for kidneys with at higher risk of failure. Second, prepare your patients, referring dialysis centers and nephrology partners. High KDPI organs often have higher rates of delayed graft function. This is expected and almost always recovers. This may be a change from past practices and you need to explain the benefit of early transplant and the requirement for short term post-transplant dialysis. If your partners understand and see the results through higher transplant rates, they will support your efforts. Third, look at your costs. Marginal organs cost more. There is an increased requirement for induction therapy, longer hospital stay, and more inpatient dialysis. You will need to be creative. Can you deliver part of the thymoglobulin as an outpatient to save cost? Have you arranged early for post-transplant outpatient dialysis? (Remember CMS now covers acute dialysis as an outpatient which assists in the case of preemptive transplant.) Do your private payer contracts provide appropriate outlier protections? Finally, once you are successful, advertise. The new SRTR 5-Tier website shows transplant rate up front. Use this. Patients are looking for ways to be transplanted. Centers that can use these organs well will experience growth in the future. Communicate this to patients, referring providers, and payers. It’s hard work and you should benefit.

The transplant community is challenged to address the ongoing crisis in organ transplant access. A discarded organ may be a missed opportunity to save a life. While careful judgement and prospective monitoring is crucial, a blanket “no” to these organs will help neither you nor your patients.

 

 

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References

  1. Stewart, Darren E. MS; Garcia, Victoria C. MPH; Rosendale, John D. MS; Klassen, David K. MD; Carrico, Bob J. PhD. Diagnosing the Decades-Long Rise in the Deceased Donor Kidney Discard Rate in the United States. Transplantation: March 2017 – Volume 101 – Issue 3 – p 575–587
  2. A. Hart, J. M. Smith, M. A. Skeans, S. K. Gustafson, D. E. Stewart, W. S. Cherikh, J. L. Wainright, A. Kucheryavaya, M. Woodbury, J. J. Snyder, B. L. Kasiske and A. K. Israni. OPTN/SRTR 2015 Annual Data Report: Kidney. Amer J Transplant. 3 JAN 2017 | DOI: 10.1111/ajt.14124
  3. Snyder JJ, Salkowski N, Wey A, Israni AK, Schold JD, Segev DL, Kasiske BL. Effects of High-Risk Kidneys on Scientific Registry of Transplant Recipients Program Quality Reports. Am J Transplant. 2016 Sep;16(9):2646-53.
  4. https://optn.transplant.hrsa.gov/news/coiin-project-studying-effective-practices-at-model-hospitals-opos/ 
  5. http://www.nephrologynews.com/national-kidney-foundation-convenes-group-identify-solutions-reduce-number-discarded-kidneys/
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