United States: The Shifting Landscape Of Organ Allocation For Transplantation

EXECUTIVE SUMMARY

The Organ Procurement and Transplantation Network ("OPTN")/ United Network for Organ Sharing ("UNOS") has recently modified the national lung allocation policy as a result of a court-ordered emergency review of a lawsuit by a lung transplant candidate in New York against the Department of Health and Human Services ("HHS"). The national liver allocation policy was similarly revised by OPTN/UNOS following a lengthy review period. In parallel, the use of CRISPR, the new gene-editing technology, has removed a key barrier to animal-to-human transplants, which could begin to ease organ allocation concerns within the next few years.

For an interim period, there is additional transplant priority for liver and lung candidates meeting certain severity of illness requirements and who are within 150-250 nautical miles of the donor hospital but in a different donor service area ("DSA"). This shift in allocation policy reflects a greater emphasis on utility and equity, but it could raise other inequities in distributing a valuable resource. As scientists move closer to achieving successful animal-to-human transplants, organ allocation concerns may diminish while burdens on the resources and administrative infrastructure of transplant programs intensify.

A report from an Ad Hoc Committee on Geography is expected in the coming months to outline protocols and establish guidelines for the use of geography within the OPTN/UNOS policies more broadly. In addition, a variety of operational and regulatory changes may be on the horizon with recent advancements in animal-to-human organ transplants. These changes could extend not only to the daily operational needs of transplant centers but to shifts in billing policies, related services such as dialysis, and attendant research and animal ethics concerns.

Nevertheless, transplant programs will continue to be subject to rigorous and complex regulatory oversight. Transplant programs and their institutions should be aware that UNOS has recently proposed modifications to "Appendix L," the section of its bylaws outlining compliance monitoring and disciplinary oversight of transplant programs.

BACKGROUND

In the field of solid organ transplantation, one of the most oftdebated topics is how best to manage organ allocation. The gap between supply and demand continues to grow, placing pressure on UNOS, which operates the national OPTN under contract with HHS, to review its organ allocation policies. According to UNOS, 20 people die waiting for an organ transplant each day, and a new transplant candidate joins the waitlist every 10 minutes.

UNOS divides the country into 11 distinct regions, each known as a donor service area ("DSA"). These regions are designed to balance an interest in keeping organs local to reduce time from retrieval to transplantation, with an interest in distributing organs over as broad a geographic area as feasible based on medical urgency. Until recently, many OPTN/UNOS organ allocation policies generally required that procured organs be offered to all transplant candidates within the DSA, including those with a relatively low severity of illness, before they are offered to patients with high severity of illness within a certain radius outside of the DSA. For example, with respect to adult lung allocation, only after all lung candidates in the donor's DSA had been offered the donor lung could it be available to patients within 500 nautical miles of the donor hospital.

However, recent shifts in policy represent a movement away from strict adherence to the DSA model. And a breakthrough scientific development could permanently alter the organ allocation landscape and create new issues for the transplant community.

LEGAL INTERVENTION AND RECENT POLICY AMENDMENTS

In November 2017, a 21-year-old New York City patient suffering from a fatal lung disease sued HHS and challenged the DSA system for lung allocation. The patient claimed that the DSAs were skewed such that she would be secondary to a less medically needy individual located farther away in New Jersey when being considered for a lung from a donor in New Jersey, just outside of the New York City area. As a result, the patient would be denied the lung solely because of her DSA listing. The suit was originally brought against HHS in federal District Court for the Southern District of New York, with the patient seeking a temporary restraining order. The court denied the request, and the decision was appealed to the U.S. Court of Appeals for the Second Circuit. HHS directed OPTN/UNOS to conduct an emergent review of its lung allocation policy, which was revised within a few days. HHS notified the court of the policy change in advance of the appeal ruling, and the patient dropped the injunction suit as a result.

Under the new lung allocation policy, a 250-nautical mile concentric circle around the donor hospital serves as the first level of distribution, rather than the DSA. The policy was revised by the OPTN/UNOS Executive Committee as a temporary measure, and will remain in effect for one year as OPTN/UNOS and HHS assess the changes it may have on the transplant allocation system.

While the lung allocation policy was amended in response to a legal challenge, OPTN/UNOS has been evaluating the effect of geography on transplant access in the liver program for the past five years. The liver allocation policy was amended in December 2017 following this lengthy review period and multiple opportunities for public comment. Among the key provisions is additional transplant priority for liver candidates meeting certain severity of illness requirements and who are either within the same DSA as the liver donor or are within 150 nautical miles of the donor hospital but in a different DSA. Coincidentally, this policy amendment was issued within days of HHS's receipt of a letter from the attorneys who represented the New York City lung patient seeking intervention on behalf of a liver patient.

While these amendments affect only the lung and liver transplant programs, this shift in policy may expand to other thoracic and abdominal organs, such as the heart, pancreas, and kidney. An Ad Hoc Committee on Geography was recently formed to establish guidelines for the use of geography within OPTN/UNOS policies generally. The Committee's report is expected in the coming months.

In focusing on medical need, rather than a patient's geographic residence and listing, the new lung and liver allocation policies reflect a greater emphasis on utility and equity. However, there are concerns that the policies' geographic shift will simply replace current disparities with new ones. In highly concentrated population centers, a shift away from DSA priority may move organs to centralized locations, thereby reducing access for smaller or rural transplant centers. Additionally, some members of the transplant community are skeptical of the use of legal challenges by individual patients to change transplant policy rather than a more thoughtful, systematic review process focused on the needs of all patients. The report of the Ad Hoc Committee on Geography is highly anticipated in the transplant community.

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