The OPTN Board of Directors recently approved the Thoracic Organ Transplantation Committee’s (Committee) Modification to the Adult Heart Allocation proposal during their December 2016. During the development of the proposal, the Committee received feedback from the heart transplant community during both rounds of public comment voicing concerns that adult congenital heart disease (ACHD) candidates may be disadvantaged by the proposed policy.1 The Committee considered the following issues in congenital heart disease (CHD) candidates:
- Higher urgency statuses are device-driven
- Variability in review board decision-making for ACHD exception requests
- Challenging to objectively quantify severity of illness
The Committee acknowledged that some ACHD candidates may have higher mortality and may not be candidates for mechanical support options, but ultimately did not change proposed policy. Short-term, the exception and review process will accommodate these candidates, who can apply for an exception in any status as their medical urgency and potential for benefit would warrant. The Committee recognized that CHD expertise may be inconsistent across the regional review boards (RRBs), thus potentially making evaluation and award of ACHD exception requests vulnerable to variability. To help mitigate these inconsistencies, the Committee created guidance for the RRBs with the goal of outlining objective criteria to standardize the evaluation and decision-making of ACHD exception requests.
This proposal aligns with the OPTN strategic goal of improving equity in access to transplants by providing objective criteria to RRBs, potentially making evaluation and award of exception requests for ACHD candidates more consistent, especially for those boards that lack a CHD expert. In addition, developing standardized exception criteria creates an intelligible pathway for more medically urgent ACHD candidates to obtain access to higher urgency statuses, under which they may be transplanted more quickly, thereby potentially reducing waitlist mortality for those candidates.
1 OPTN/UNOS Board Briefing. Proposal to Modify the Adult Heart Allocation System. Accessed June 27, 2017. https://optn.transplant.hrsa.gov/media/2006/thoracic_brief_201612.pdf.
Impact points
- VERY SMALL: UNOS implementation effort for all departments
- Minimal or no impact for members. Hospitals must educate staff on exceptions and updates, but no substantial fiscal impact results
- Immediate to within one month to implement for members
- Guidance documents do not contain new member requirements. However, the assumption in estimating fiscal impact is the members will follow guidelines
Project Size/Complexity
UNOS
Implementation and ongoing effort among all departments is very small.
MEMBER
- Hospital: Staff time to develop standardized exception criteria and education for the transplant team is minimal. Ongoing effort includes educating any additional new staff. Hospitals are likely to absorb these minimal costs.
The size of the heart program, and its staff is a major variable in creating additional cost, if any. The overall number of heart candidates is small, and so the proposal affects a small percentage of all heart candidates.
- OPO and Lab: Minimal or no impact.