Over a 5-year period during the 1990’s, the OPTN tried and failed to reach consensus on liver allocation policy revisions aimed at broader sharing for liver allografts, particularly for the most urgent patients. The Secretary of Health and Human Services became involved and one result was implementation of federal transplant regulations, the OPTN Final Rule in March 2000. The Rule stipulates that OPTN allocation policies must, among other factors, be based on sound medical judgment, seek to achieve the best use of donated organs, and shall not be based on the candidate's place of residence or place of listing except to the extent needed to satisfy other regulatory requirements.1 The Rule stipulates additional OPTN requirements and restrictions that previously did not exist.
During the years immediately following Final Rule implementation, the MELD and PELD disease severity scoring systems were developed, seen as the first necessary step before readdressing broader liver sharing.2 Additional liver allocation policies followed, with the understanding that the OPTN was moving toward broader sharing to reduce the observed geographic inequity in access to liver transplant for the sickest candidates. On November 13th, 2012, the OPTN/UNOS Board of Directors directed all OPTN organ-specific committees to identify allocation equity metrics appropriate to their organ types.3 The Liver and Intestinal Organ Transplantation Committee (hereafter called “the Committee”) selected variance in median MELD at time of transplant (for exception and non-exception candidates), among other metrics, and observed continued and significant variance in this metric across regions. The Board instructed the Committee to develop evidence-based policy proposals aimed at reducing this variance in accordance with the Final Rule.
The OPTN recognizes that there are not enough organs for patients in need of lifesaving transplants and is invested in increasing the number of transplants each year by increasing donation, reducing organ discards, and improving OPO performance. However, these efforts will not change the fact that current regional boundaries often physically separate urgent candidates from donors in close proximity. The result is that in some areas of the United States, candidates must reach a higher MELD or PELD score in order to get a transplant.
In progress for the last 5 years, the current proposal strives to balance equity in access while limiting the impact on travel and logistics. The Committee proposes a solution that implements a 150 nautical mile radius sharing circle around the donor hospital and increased sharing within the region. The 150 mile circle may include candidates outside of the region. Candidates at transplant hospitals within the circle will receive 5 additional MELD or PELD points. The Committee proposes sharing in the initial broader classification to be limited to candidates with a calculated MELD of at least 29 (candidate age greater than 18 at time of registration) and allocation MELD or PELD of at least 29 (candidate age less than 18).
1 42 C.F.R. § 121.8, available at Electronic Code of Federal Regulations
2 A liver candidate receives a Model for End-Stage Liver Disease (MELD) score or, if less than 12 years old, a Pediatric End Stage Liver Disease (PELD) score that is used for liver allocation. This calculated score is intended to reflect the candidate’s disease severity, or the risk of 3-month mortality without access to liver transplant. Some candidates receive an “exception” MELD or PELD score when the urgency of their need for liver transplant is not reflected by the calculate “lab” MELD/PELD score.
3 OPTN Board resolution “the existing geographic disparity in allocation of organs for transplant is unacceptably high, and directing the organ-specific committees to define the measurement of fairness and any constraints for each organ system by June 30, 2013”
Impact points
- Enterprise: UNOS IT effort to implement is 10,000 hours for allocation modifications.
- UNOS Departments including Policy, Instructional Innovations, and Research require significant effort to provide support to educate and prepare for implementation updates
- 1-3 month implementation time upon programming for members
- Substantial increased cost may result with transplant volume and/or higher transportation cost; additional staff or staff hours may be required to administer additional procurements.
- Increased cost will likely be different among regions and among centers.
- Uncertainty of how additional cost may be absorbed with existing staff and commercial and managed care contract arrangements
- Decrease in transplant volume may cause financial strain on smaller programs, due to loss of revenue
- Financial impact highly dependent on local change in volume
Project size/complexity
UNOS
IT Implementation effort to modify allocation is substantial, at 10,000 hours. Hours include modification of variances for Region 9 and Hawaii. Implementation timeframe is eighteen months from Board approval, to implement after the National Liver Review Board (approved June 2017). Ongoing effort to maintain is similar to the current allocation system, so there is no significant ongoing effort.
Policy effort to implement includes time spent preparing and executing subcommittee meetings and preparing materials for Committee and stakeholder updates. A large Instructional Innovations effort is needed to create multiple offerings to educate the community on changes.
MEMBER
Hospital: Implementation requires clinical and administrative staff time to revise protocol, educate other team members, and to establish logistics with additional partners. The timeframe to implement is almost immediate to a few months, depending on the hospital. Additional staff time to implement is estimated to total up to $3,000.
If liver recovery volume increases substantially, hiring additional staff may be needed. On call administrative and clinical (surgeons) staff can increase costs. Increased volume may require additional procurement personnel and/or on call surgeon availability. If OPO import offers increase substantially, some coordination may be shifted to hospitals, further impacting staffing. Lab fees to conduct crossmatching may increase, as well, although most livers are not crossmatched.
If additional flights are required for livers (with or without increased procurement volume), the cost per transplant case can rise substantially. Cost of transportation differs across regions, potentially causing the cost per liver transport to vary. Depending on the payer agreement, hospitals are reimbursed an average/standard acquisition cost per case. The standard acquisition cost may remain stable despite the occurrence of more flights. The hospitals must pay the cost of transportation and recovery team even if reimbursement of expense cannot be claimed. It will also require transplant centers’ time to evaluate potential increase in organ acquisition and impact on existing commercial and managed care contracts.
Procurement costs, including flights, must often be paid up front by the importing hospital if the liver is from outside of the local region. OPOs outside of the local region may also charge different fees, causing uncertainly about overall cost impact. Increase in volume will create additional revenue overall. It is uncertain whether or not additional revenue can offset additional costs that hospitals may incur.
It is possible that smaller liver programs will see a decrease in volume and greater competition with larger regional programs, especially in dense areas. This may cause a decreased need for staff or surgeons, and a loss in revenue. Smaller programs may have marginal ability to absorb an increased cost per case, especially if courier fees for a number of cases increase. This could result in some smaller programs eventually closing, potentially impacting patient access to services.
Overall, fiscal impact will differ among all programs. Change in cost is highly dependent on change in liver volume, change in length of stay per case, regulatory and private payer mix, additional supplier contracts, and competition from peers. Because impact analysis of the regional level is not available, local impact is a challenge to project.
OPO: Additional staff or hours may be required for coordination if the number of imported livers increases in a substantial way. Additional fees for imported organs from outside of the local region may be collected, as well. Additional costs incurred by the OPO are typically included as a part of the acquisition fee, so are shifted to hospitals to claim as reimbursement.
Lab: Minimal or no impact.
(PDF - 11 M; 11/2017)