Woman’s Lawsuit Put Emphasis on ‘Urgency’ in Deciding Organ Transplants in US

Waiting for a lung transplant in the intensive care unit at a New York hospital in November 2017, a 21-year-old pulmonary hypertension patient named Miriam Holman sued the U.S. Department of Health and Human Services.

Her lawsuit accused the department of allocating organs based on a patient’s geographic location, rather than medical urgency — as was required, in accordance with “sound medical judgment,” when determining organ availability under a “final rule” established in 1998.

The United Network for Organ Sharing (UNOS) — which acts as the Organ Procurement and Transplantation Network (OPTN) named in the suit — was in violation of this rule because, the lawsuit stated, it allowed priority to continue to be given to patients on transplant lists within the organ “donor’s service area” (DSA). That was common practice before 1998.

Five days after her lawsuit was filed in a U.S. District Court, UNOS changed its policy to strengthen organ sharing over greater distances, removing DSA from the “first tier” in allocation decisions.

Holman appears to have been right in arguing that the 1998 final rule was not being practiced in her case.

A study published in the American Journal of Transplantation on Nov. 6, 2018, titled “Geographic disparities in lung transplant rates,” showed that before UNOS’ emergency change in policy, a patient’s location still had a much greater impact on the likelihood of receiving a lung transplant than overall lung health.

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“We really wanted to investigate whether that problem [Holman] was having was actually being experienced by many patients across the country,” Sommer Gentry, a professor of mathematics at the United States Naval Academy and a lead study author, told Cystic Fibrosis News Today.

The research team found that “geographic disparity was a problem generally for all of the people across the country waiting for a lung transplant,” Gentry said.

UNOS now considers for eligibility any person listed for transplant within a radius of 250 nautical miles from a donor’s location, rather than within set DSA boundaries. The new rule better complies with the final rule, but the distance is still arbitrary.

“The 250-mile rule as far as I’m concerned is only temporary and we definitely will be working on optimizing the lung organ allocation system,” said Kevin Chan, medical director of lung transplant at the University of Michigan Medical School and chair of OPTN’s Thoracic Organ Transplantation Committee in 2017.

The time in which donor lungs can be preserved, transported, and remain viable must be an important consideration, Chan added, as will the cost of doing so.

In the 1980s, as physicians and researchers began turning to organ transplants as a viable treatment approach, the government needed a way of determining which patients would receive donor organs as they became available. The national transplant system was set up in 1984, establishing the OPTN, which maintained a nationwide organ matching registry.

To help manage the process, 58 DSAs were designated transplant centers across the U.S. When an organ became available, it was first offered to patients inside the DSA. Only if no match was found was consideration then given to those outside.

For lung transplant candidates, a Lung Allocation Score (LAS) was developed in 2005 to establish and compare medical urgency. It is a combined measure of how badly a patient needs new lungs, and survival chances upon receiving them. Patients with the highest scores should be offered lungs before those with lower scores.

Holman’s score was over 90 out of a possible 100.

Analyzing Disparity

The problem with “donor service areas” as a key determinant of organ availability is that not all DSAs  are equal. Myriad factors, ranging from the average age of the population to the local enforcement of helmet laws for motorcyclists, can affect the supply and demand for organs in particular areas, making waiting lists in some regions years longer than in others.

In their 2018 study, the researchers analyzed data from 7,131 people active on the lung transplant waiting list between Feb. 19, 2015, and March 31, 2017, to determine transplant rates, using the final rule allocation system before its lawsuit-prompted update. They calculated patients’ likelihood of getting a transplant based on LAS, blood type, age, and DSA.

Results showed that DSA — donor and patient geography — was significantly more important than LAS on the chances of being offered a lung transplant.

“Changing a candidate’s DSA would have had a greater impact on the candidate’s LT [lung transplant] rate than changing LAS categories,” the researchers wrote.

For instance, its data showed that — at its extreme — a patient with the same LAS and blood type in one DSA could have a 21.73-fold better chance of getting a transplant if he or she were evaluated in another DSA.

On average, candidates with the same LAS and blood type in two different DSAs had a roughly two-fold difference in their chances of a transplant, while moving up from one LAS range to the next — implying greater urgency — increased a patient’s likelihood of getting a transplant by about 1.5 times.

In Holman’s case, were she listed in neighboring New Jersey rather than New York City, she would have had a “significantly higher” chance of getting new lungs, the study reported. The difference in transplant rates for people with comparable LAS scores (range of 50–100, implying urgency) was nearly four-fold higher in that nearby state.

“For New Jersey and New York DSAs being right next to each other, that’s just an unbelievable discrepancy in the transfer rate,”  Martin Kosztowski, a research fellow at Johns Hopkins University School of Medicine and first author on the study, said in phone call.

Some patients have tried to get around limitations based on location by registering at multiple centers, but this option is available only to those with enough time, money, and physical strength to undergo multiples evaluations in different areas.

Questions Remain

Most experts agree that the new rule is a step in the right direction, but have yet to see how much it will help even out geographic disparities.

Rather than designate a standard radius, Gentry — who uses mathematical models in an attempt to optimize organ allocation — suggested that irregular areas based on population, donation rates, and need may be more effective.

Pablo Sanchez, surgical director of lung transplant at the University of Pittsburgh Medical Center, said that the new rule has helped his patients, many of whom have “really high LAS scores,” and “those patients are being prioritized.” But with national data yet to be published, he cannot be sure how other centers might see things, he said in a phone call.

Not everyone is as enthusiastic. Some surgeons in hospitals with shorter wait times are concerned that their patients might have to wait longer should local organs be shipped to big cities.

“The success of transplants is based on a gift from the local community,” Prabhakar Baliga, a transplant surgeon at the Medical University of South Carolina, told the Los Angeles Times. “Taking away organs from South Carolinians is unfair.”

But Gentry said most donors don’t seem to mind.

“The donors and the donor families are motivated by saving someone’s life, saving another American’s life, even if that person was in a different part of America,” she said. “The hospitals and the physicians may want the organs to stay local, but that does not line up with donor mission in general.”

A 2012 survey found that 81.7 percent of respondents said they would prefer their organs go to those with the greatest medical need, regardless of location.

“It’s definitely a more rational policy than the arbitrary borders of the donation service area, but we could probably still do better than the 250-mile circle,” Kosztowski said. In a year or so, when data are available, his team is “definitely going to study it and then see what the results show.”

The 250 nautical mile-rule is intended to be temporary. Patients and caregivers are invited to view webinars and participate in public comments on proposed policies at the OPTN website, or apply to volunteer on planning committees.

Miriam Holman, whose lawsuit was a driving force in these changes, finally underwent a lung transplant in January 2018, but died later that same month, her father, Glen Holman, said in an email message.