UNOS Lung Allocation Policy

At the end of 2017, the transplant community saw changes to the OPTN lung allocation system that came as a surprise to many. Following a suit in federal court, the donor service area (DSA) distribution was replaced with a 250-nautical mile circle around the donor hospital.

To provide further detail on this recent change, I have invited UNOS Chief Executive Officer, Brian Shepard, to write a guest blog post on this topic.

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Last fall, the transplant community was surprised and concerned by a fast-moving series of events that resulted in a sudden change to lung allocation policy. UNOS acted that week to protect the community’s ability to shape OPTN policy, and we are taking additional steps now to reduce the risk of an external intervention in the future.

On the Monday before Thanksgiving, a lung transplant candidate filed suit in federal court, alleging that lung allocation policy violated the OPTN Final Rule. While geographic constraints are permissible to meet specific requirements in the regulation, the patient argued that the use of DSAs for organ distribution – with their widely varying sizes, shapes, populations, and demographics – could not be justified.

Under a judge’s deadline, the Executive Committee evaluated ways to defend or amend the policy, the likelihood of success, and the potential consequences of each option. Ultimately, successful defense of the lung policy seemed unlikely due to its complete dependence on DSA-first distribution, with no exceptions for urgent or sensitized candidates or other justification permitted by the Final Rule. The consequences of having a new policy forged by court order would take not only this decision, but potentially future lung policy changes, out of the community’s hands.

Accordingly, the Executive Committee approved an immediate change to the lung policy, replacing the DSA distribution with a 250-mile circle that would be consistent nationwide. UNOS implemented the change immediately, and the plaintiff withdrew the suit.

The overreliance on DSAs that made the lung policy susceptible to legal challenge also made it relatively easy to program. Changing a more complicated policy, like liver with its multiple overlapping layers, would not be possible in the same timeline.

Immediately afterward, UNOS created an Ad Hoc Committee on Geography that will report to the Board in June. The Committee, made up of society representatives, board members, and chairs of the organ-specific and other committees, was tasked with outlining a principled and consistent approach to geography that is clear to the community, compliant with the regulation, and if necessary, legally defensible.

The requirement for geographic equity in access is different from the other requirements in the Final Rule.  The Rule does not call for balancing– it calls for geographic equity except as required to meet the other requirements.  That construct obligates us to demonstrate how geography-based rules are necessary to promote utilization, reduce cold time, or make the system more efficient.  It doesn’t mean we can’t have rules, but it does mean we have to show our work.

The Geography committee’s work will be part of the public discussion at summer regional meetings and other venues.  The organ-specific committees – whose chairs serve on the Geography Committee – will then examine their own policies in light of the Geography Committee’s work and lessons learned from the lung lawsuit.  Any proposed policy changes that come from those reviews will be developed by the organ-specific committees, offered for public comment, and considered through the full OPTN policymaking process.

Many were surprised by the events of last November. We won’t be able to claim surprise when it happens again. We need to prepare, by ensuring that our approach to geography is supported by evidence, well-documented, and compliant with the Final Rule.

 

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