As Stakeholders Debate Organ Allocation Rules, Courts May Push Change

Originally published in Modern Healthcare

By Susannah Luthi

The week before Thanksgiving, 21-year-old Miriam Holman breathed through an artificial machine in the Columbia University Medical Center intensive-care unit. Her disease—a rare form of pulmonary hypertension—is incurable and she is in danger of dying soon without a lung transplant. But she lives in New York, or, in organ allocation parlance, Region 9, which has fewer locally procured organs than most other regions, according to data from the United Network for Organ Sharing. 

UNOS, the private, not-for-profit in charge of the organ transplant system, divides the country into 11 regions, essentially demarcating borders within which organs move from donor to recipient. The system was abruptly changed as a result of the first legal challenge to these borders in years, which came Nov. 19, in Holman's name.

Attorneys filed an emergency complaint against HHS on her behalf. They sought an injunction on UNOS' regional policy that is much-debated but seldom changed.

The Holman lawsuit set in motion a rapid succession of government counter-appeals and new court orders. It culminated in a Thanksgiving change to a rule on lung allocation, expanding the procurement area to a 250-mile radius around a patient's donor service area.

Transplant surgeons have met this development with mixed reactions. Concern focuses on the role courts may now play in policy for other organs, particularly livers. On Dec. 1, the attorneys that represented Holman sent a letter to HHS acting Secretary Eric Hargan, seeking intervention on behalf of 25-year-old Tamiany de la Rosa, who waits for a liver at Mount Sinai Medical Center in New York City.

De la Rosa is ranked among the very sickest of patients awaiting a liver; she could die within three months if she doesn't get a new one.

Dr. Ryutaro Hirose, a nine-year member of UNOS and former chair of the UNOS liver committee, said the courts aren't the best option to push major change. 

But Hirose represents the transplant center at the University of California at San Francisco—California is another region with far more patients than organs—and said he's spent the past several years witnessing the same arguments from the entrenched haves and have-nots of organ allocation without seeing substantive change. Legal action, he said, is "one way of getting things done."

This isn't to say change never happens. In early December, three days after de la Rosa's attorneys sent their letter, UNOS met and approved a new policy expanding access to livers for patients at a certain sickness threshold to within a 150-mile radius of their service area, while boosting priority for local people on the liver waitlist. 

The UNOS board also appointed an ad hoc committee of representatives from each region to look at the geography issue, but their report isn't expected until the spring of 2018.

Given the complexity of liver policy, Hirose said that even a baby step gives him hope.

Nonetheless, the Holman lawsuit is a warning to UNOS. Hirose said he hoped it spurs the committee to make a more drastic policy change in their process "as opposed to judicial mandates or external government regulators." 

But not everyone is in favor of big change. Dr. George Loss, chief of the Multi-Organ Transplant Institute at Louisiana's Ochsner Health System, agreed with policy critics that this latest tweak won't massively boost the number of livers available in New York. He said transplant centers should deal with their shortage another way: by more aggressively using marginal or "high-risk" livers from outside their regions, which could expand liver availability by as much as 20%.

Use of high-risk livers widens a center's access to livers from outside their UNOS region. This is because they get the first call from organ procurement organizations unable to place damaged livers within their region. A liver must be transplanted within hours of removal, so centers known for using marginal livers get expedited treatment.

There is no definitive measure, or definition, of marginal livers. UNOS compiles data on how many livers are recovered, transplanted or not, and breaks down the reasons why. The most common reasons a liver isn't transplanted are poor organ function or the donor's medical history.

Hirose agreed that organizations ought to be more aggressive in the way they approach liver procurement, including finding new donors, but the argument is very different from the one swirling around changing regional allocation policy. 

"The borders were not designed by gerrymandering to make disparities; they were drawn randomly without design or intent to be used as organ distribution areas," he said.

He noted that any big change to allocation rules would hit some centers' profits in a big way. For example, Californians who can afford it, travel to Ochsner to get a transplant.

And some fear that if more livers are sent to larger cities, smaller centers will become vulnerable. "You are potentially trading one disparity for another disparity of access to an actual transplant center," said Joey Boudreaux, chief clinical officer of the Louisiana Organ Procurement Agency.

As stakeholders debate the what-ifs, the waitlists in organ-scarce regions aren't getting shorter and patients like Holman and de la Rosa may spur the courts to draw their own conclusions, and possibly their own boundaries.

Billy Wynne