Thoracic Organ Transplantation Committee Spring 2017

Recent Public Comment Proposals Second round of public comment in fall 2016 Most substantive change: scaling back initial qualifying period and extension timeframe for VA ECMO in status 1 from 14 to 7 days Board of Directors approved proposal during their December meeting Implementation – contingent on IT programming and notification to members Modification of the Adult Heart Allocation System The proposal to modify the adult heart allocation system went out for two rounds of public comment. The OPTN Board of Directors approved the proposal during their December meeting. This proposal suggested modifications to the adult heart allocation system to better stratify the most medically urgent heart transplant candidates, reflect the increased use of mechanical circulatory support devices (MCSD) and increased prevalence of MCSD complications, and address geographic disparities in access to donors among heart transplant candidates. Overwhelmingly, a majority of the status 1 feedback pertained received from both rounds of public comment pertained to VA ECMO. As this was perhaps one of the more controversial components of the proposal, the Committee debated several options. Ultimately, the Committee was amenable to changing the initial status timeframe and extension period from 14 days for these candidates to 7 days. Implementation is contingent on IT programming and notification to members and will occur no sooner than December 2017.

Policy Implementation Dates Proposes broader geographic sharing of pediatric donor lungs and establishing eligibility criteria for candidates registered prior to their second birthday to receive offers for deceased donor lungs of any blood type Transplant programs should consider the appropriateness of registering patients meeting criteria as eligible to accept an intended blood type incompatible lung Implementation date: Early 2nd quarter 2017 Proposal to Modify Pediatric Lung Allocation Policy This policy entails two additional policy provisions to improve access to transplant for all pediatric candidates less than 18 years old. First, it proposes broader geographic sharing of pediatric donor lungs. This will give candidates less than 18 years old better access to properly sized donors, which aligns with Goal 2 of the OPTN Strategic Plan. Second, it establishes eligibility criteria for candidates registered prior to their second birthday to receive offers for deceased donor lungs of any blood type. This will increase utilization of the smallest donor lungs and decrease waiting list mortality among infants, which supports Goals 1 and 3 of the OPTN Strategic Plan. This proposal requires members to submit additional data. Transplant programs should consider the appropriateness of registering patients meeting the criteria as eligible to accept an intended blood type incompatible lung. Organ Procurement Organizations (OPOs) will need to educate their staff on the new allocation algorithm

Committee Projects Congenital Heart Disease Guidance Document Heart transplant community concerned that new heart allocation system would disadvantage adult CHD candidates Drafting RRB guidance in response that addresses variability in the exception review process Considering developing additional guidance pertaining to the other diagnosis groups in status Congenital Heart Disease Guidance Document During both rounds of public comment, the heart transplant community voiced concern that adult congenital heart disease (CHD) (and others in Status 4) candidates would be disadvantaged by the new heart allocation system. The Committee was unable-based on existing data-to define a subset of CHD patients with consistently higher mortality. Rather, the waitlist mortality of these patients placed them clearly within Status 4. However, the Committee recognizes that some patients with these diagnoses will have higher mortality and may not be candidates for the mechanical support options leading to higher status within the policy. In the short-term the exception and review process will have to accommodate these patients (who can still be listed at as high a status as their predicted mortality would warrant, including Status 1). While there are concerns regarding the equity of the review process, the Committee additionally believes that changes to the RRB process envisioned in this proposal will minimize the potential for biased decision-making. The Committee is also drafting guidance for regional review boards to address variability in the exception review process. While this resource is limited to CHD, the Committee is considering developing additional guidance pertaining to the other diagnoses groups in status 4 for the regional review boards.

Questions? Kevin Chan, MD Committee Chair kevichan@med.umich.edu Kimberly Uccellini, MS, MPH Committee Liaison Kimberly.Uccellini@unos.org