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December 11, 2018

'A giant step' or 'a disaster?' Why experts are split on the just-approved liver distribution policy.

Daily Briefing

    The Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS) last week approved a new liver distribution policy intended to prioritize patients with the most urgent medical needs and reduce geographic disparities in the distribution of livers for transplant, U.S. News & World Report reports.

    Here are 5 key tactics to attract and retain transplant patients

    Background: US system for distributing livers comes under fire

    As many as five individuals die waiting for a liver transplant each day, according to the Washington Post. About 13,500 U.S. residents were on the waiting list for a liver transplant in 2017, but only about 7,700 U.S. residents received a liver transplant, the Post reports.

    The United States currently is divided into 11 regions in which livers are allocated by need. Under the current system, livers are first offered to the sickest patient within the region where the liver becomes available. Transplant patients are given a so-called MELD score, estimating their current risk of death, which is based on a 40-point scale. Pediatric transplant patients are given a PELD score. If a there is no match for a liver within the region where it was donated, the liver can be distributed to other regions.

    In some instances, a patient in one region could be on the verge of death before he or she qualifies for a liver, while comparatively healthier patients receive livers in other regions. Individuals seeking a transplant can move to increase their chances of receiving a liver. However, not everyone is aware of or can afford that option.

    To address that issue, the OPTN/UNOS Board of Directors in December 2017 voted 36-3 with one abstention to approve policy amendments to change how livers are allocated for transplant in the United States. The new policy extended the area where a liver is offered for transplant and prioritized adult liver candidates with a calculated MELD score of 32 or higher and pediatric candidates younger than age 18 with a MELD or PELD score of 32 or higher. The board of directors had not established an implementation date for the policy amendments.

    But in July, six liver transplant candidates from California, Massachusetts, and New York filed a lawsuit against HHS, OPTN, and UNOS over the country's system for allocating liver transplants. The plaintiffs argued that the regional system violates federal law requiring an equitable distribution policy. In response to the lawsuit, George Sigounas, the top deputy of HHS' Health Resources and Services Administration, ordered OPTN to eliminate the regional system by December 2018.

    OPTN/UNOS approve new distribution policy

    The OPTN/UNOS Board of Directors last week voted 30-7 with two abstentions to approve a new liver distribution policy. UNOS said fewer than 50 liver candidates across the United States would qualify as a priority patient "at any given moment" under the new policy.

    Under the new policy, livers donated from individuals who are at least 70 years old or who die from cardiorespiratory-related issues would first go to patients who live within 500 nautical miles of the donor hospital and have the most urgent medical need. After those patients, such livers then would go to patients with a MELD or PELD score of 15 or higher who are located within 150 miles of the donor hospital.

    In addition, livers donated from individuals who are younger than 18 would first go to liver candidates younger than age 18 who are located within a 500 nautical-mile radius of the donor hospital. OPTN/UNOS said, "This will give additional priority to pediatric transplant candidates compared to the current distribution system."

    According to OPTN/UNOS, "Simulation modeling of the approved system indicates it will reduce variation in transplants by MELD score that exist in various areas of the country under the current liver distribution system." OPTN/UNOS said, "Modeling further suggests [the new policy] will reduce pre-transplant deaths and increase access for liver transplant candidates younger than age 18."


    Sue Dunn, president of the board, said, "The Board carefully weighed a number of options, with the ultimate goals of best honoring the gift of organ donation and helping those in greatest need. This model represents a necessary step forward to address long-existing differences in transplant in various areas of the country."

    Motty Shulman, an attorney for representing the patients who filed the lawsuit challenging the current distribution system, said the new policy represents "a giant step" that will "benefit the over 13,000 individuals currently on the liver waitlist and thousands more in the years to come."

    However, Raymond Lynch, a liver transplant surgeon and assistant professor of surgery at Emory University School of Medicine, called the new policy "a disaster." Lynch said the new policy will benefit patients who live in large metropolitan areas, but hurt patients who live in rural regions, where U.S. residents have limited access to health care services and therefore are less likely to be diagnosed with liver disease and be placed on a waiting list for a transplant.

    Lynch explained that statistical modeling shows the new policy will result in transplant centers in metropolitan New York receiving more than 100 livers annually over the previous system, with those livers coming from states with rural regions, such as Alabama, Georgia, Louisiana, Michigan, and Tennessee. Lynch said, "We should not kid ourselves. When you move a liver, you move a death" (Luthi, Modern Healthcare, 12/7; Bernstein, Washington Post, 12/5; Newman, U.S. News & World Report, 12/6; OPTN release, 12/4).

    Here are 5 key tactics to attract and retain transplant patients

    Download this briefing to learn how to expand the pipeline of potential transplant patients and engage them across the care pathway.

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