University of Iowa among hospitals suing feds over organ-donation changes

IOWA CITY — As part of a Midwestern and Southern collective of health systems with kidney transplant programs, the University of Iowa is battling a new nationwide policy it argues gives differential treatment to densely populated East and West Coasts regions at the expense of its kidney transplant patients.

Suggesting there are nefarious objectives and unethical financial motives, the litigants including UI Health Care assert in a federal lawsuit that the new kidney distribution policy — which replaces a long-standing regional model — will mean fewer donated organs and transplant operations for their patients.

“And the costs of kidney transplants will increase due to additional transportation costs and administrative burdens,” according to the lawsuit filed Dec. 9 against a group of defendants including the U.S. Department of Health and Human Services, then-department secretary Alex Azar and the United Network for Organ Sharing.

Signing on as plaintiffs to the lawsuit — which has swapped out Azar with new Acting Health and Human Services Department Secretary Norris Cochran — are hospital systems in Orlando and those associated with the universities of Iowa, Alabama, Kansas and Kentucky.

Those organizations report the expected drop in transplants and rise in costs could “threaten the long-term viability of plaintiffs’ transplant programs, as well as make it difficult to retain qualified medical specialists.”

“Many of plaintiffs’ patients will not receive organs that they would have otherwise received under the previous policy,” the lawsuit alleges.

According to the Iowa Donor Network, 485 Iowans were on a wait-list as of Dec. 1, 2020, to receive a kidney transplant. That was far more than the 40 awaiting liver transplants and 24 awaiting heart transplants at the same time.

Liver changes

The kidney-allocation policy at the center of the suit comes on the heels of a similar new liver-distribution method. That new system replaced a decades-old process using geographic boundaries involving 58 donation service areas and 11 transplant regions. Iowa’s service area was simply its state borders, excluding Pottawattamie County — home to Council Bluffs, which is included in Nebraska’s area.

Health care providers, including UIHC, mounted a similar legal challenge to the liver change — and lost.

Like the revised kidney-allocation policy, the liver amendment re-prioritized donations first to the sickest and longest-waiting candidates at transplant hospitals within 250 nautical miles of the donor hospital. A nautical mile is slightly longer than a standard mile, making the new geographic circle for kidney distribution about 288 traditional miles. Organ offers not accepted within the nautical-mile circle then can go to candidates elsewhere.

Opponents have said the changes harm Midwest and Southern states, which have more available organs and shorter wait-lists. Conversely, they benefit coastal states, which have long wait-lists but not enough donors.

UIHC Organ Transplant Center Director Alan Reed told The Gazette those fears are bearing out in the wake of the liver-allocation change in February 2020, reporting the new policy has had a “devastating impact on the quantity and quality of livers offered to patients on our list.”

Iowa Donor Network donation activity, Jan. 1, 2020 — Nov. 30, 2020

Organ donors: 95

Organs transplanted: 285

Tissue donors: 821

Local and national wait-list as of Dec. 1, 2020

National organ wait-list: 108,619

Iowa organ wait-list: 565

Iowa organ wait-list by organ as of Dec. 1, 2020:

Kidney — 485

Liver — 40

Heart — 24

Lungs — 10

Kidney/Pancreas — 6

Pancreas — 0

(Source: Iowa Donor Network)

In the six months after the liver-distribution change, UIHC saw a nearly 30 percent drop in liver transplants — from 17 operations between Aug. 4, 2019, and Feb. 3, 2020, to 12 between Feb. 2 and Aug. 4, 2020. So far this calendar year, UIHC has done just three liver transplants — far fewer than most years through April, UIHC officials said.

Organ donation stats and facts

Every 10 minutes, another person is added to the national organ transplant waiting list;

An average of 20 people die every day waiting;

An average of 92 transplants take place daily in the United States;

Nearly 40,000 American lives were saved by organ donation in 2019;

Nearly 7,400 living donors gave in 2019;

One donor can save up to 8 lives through organ donation and save and heal more than 200 lives through tissue donation;

Every driver’s education class in Iowa must have one educational session on organ, tissue, and eye donation.

(Source: Iowa Donor Network)

Under the new policies, patients in areas like Chicago, Milwaukee, St. Louis, Kansas City or Minneapolis might need to pass up an organ — even one from an Iowa donor — before it could come to a patient in his or her state. And those urban centers are more likely to have sicker patients-in-waiting at all times.

“This change hurts rural programs like ours because kidneys procured in our area are now being sent outside the region to larger population bases instead of being allocated to patients in Iowa,” Reed said.

‘This will help’

Proponents of the changes say they use a “more consistent measure of distance between the donor hospital and the transplant hospital” and will improve “equity in transplant access for candidates nationwide.”

“The new organ allocation system replaced a highly inconsistent set of local and regional boundaries historically used to allocate these organs,” according to Anne Paschke, a spokeswoman for the United Network for Organ Sharing, which helped develop the changes and is among the defendants UIHC and its peers are suing.

“This will help ensure that the system is based appropriately on the medical needs of patients rather than artificial dictates of geography.”

The new policies were developed over three years and involved “expert study and multiple rounds of public input and comment,” according to Paschke.

Court rejection

Despite the ongoing legal battle, the kidney-allocation changes took effect March 15 — about a year after the liver distribution changes materialized.

The restructured kidney distribution was allowed to proceed — even with the court case unsettled — after a federal judge on March 12 denied the plaintiffs’ request for a temporary restraining order and immediate injunction to prevent “irreparable harm.”

The judge found the hospital systems failed to show a “likelihood of success” in their case for several reasons, including that they waited so long to file suit — failing to even log a critical comment with Health and Human Services until under two weeks before implementation.

Still, in continuing with their lawsuit, the concerned hospital systems insist increasing logistical complexity of the new policy will up the time an organ is outside a body and inevitably increase the cost of procuring organs.

That, according to the lawsuit, will increase “the graft failure rate per patient year” and “create greater waste of donated organs due to increased reliance on inconsistent and frequent delayed commercial flights.”

COVID-19 complexities

Not only would heavier reliance on commercial flights disadvantage rural regions without nearby airports, the suit said, COVID-19 has heightened the risk of that reliance.

The hospitals argued that with U.S. death tolls and hospitalizations it is “a uniquely terrible time to throw out 30 years of established practice and implement a complex new nationwide policy on the allocation of lifesaving organs.”

Even without the policy changes, the Scientific Registry of Transplant Recipients was reporting COVID-19’s massive impact on the transplant system — affecting “virtually all aspects of kidney transplantation,” the suit said.

Given geographic differences in the pandemic’s impact, however, the registry has struggled to ascertain the true impact of the liver-policy change, according to the lawsuit — adding, however, “It knows the number of liver transplants has declined.”

But the judge rejected those COVID-19 arguments, too, reporting the Organ Procurement and Transplantation Network “invested many resources in organ transplantation monitoring and coordination among donors and candidates in response to the challenges posed by COVID-19.”

Comments: (319) 339-3158; vanessa.miller@thegazette.com