For 32 years, the nonprofit United Network for Organ Sharing has held the federal contract to run the complex U.S. transplant system, a round-the-clock operation that matches donated organs with the sick people who need them.
The Richmond, Virginia-based UNOS has grown substantially and become more entrenched as transplantation has expanded. It collected nearly $58 million in revenue in 2015, according to federal tax records. But it has not faced competition from any other bidder since before 2005.
This year, with the contract up for renewal, at least two groups are exploring a bid against UNOS. They have criticized the organization as inefficient and slow to change - two reasons why nearly 115,000 people are on waiting lists for organs, they say. Some patients have been seeking kidneys, livers, lungs and other organs for years.
But the challengers are running into unexpected obstacles. When the government released its solicitation for bids on March 30, it gave outside groups only 31 days to respond, which the challengers said was a near impossibility for anyone trying to create a plan to manage a network of more than 800 transplant programs. The deadline was later extended to May 4, giving them 35 days.
The federal Health Resources and Services Administration also is requiring bidders to have three years of experience managing transplant projects of similar complexity - a description, one group said, that only fits UNOS.
And if one of the upstarts did win the contract, it would not inherit the software developed by UNOS or its computer equipment, the guts of the complicated system that sometimes must match donors with faraway recipients in just a few hours. The government plan for a transition also favors UNOS, according to the challengers.
"We want to either see UNOS work better or see the ... contract open to fair, competitive bidding," said Sommer Gentry, a mathematics professor at the U.S. Naval Academy and a member of a group based at Johns Hopkins University that may vie for the contract. The group is supported by a $250,000 grant from the Laura and John Arnold Foundation, which funds initiatives in health care, education, criminal justice and other areas.
An HRSA spokesman said in an email Monday that the agency "is not considering altering these requirements" and that the documents released last year gave any prospective bidders the information they would need to prepare a bid.
Organ transplantation is a tiny part of the vast health-care system overseen by the Department of Health and Human Services, which will spend more than $1.1 trillion in fiscal 2018. More than 90 percent of UNOS's revenue comes from the fees patients pay to be listed with the network when they need an organ.
Even with a recent surge in donors because of overdose deaths from the opioid epidemic, the system is perennially short of meeting the demand. An average of 22 people on the waiting lists die each day, according to UNOS.
The organization's leaders took years to develop a policy to address regional disparities in liver supply before settling on a plan in December that will initiate modest changes. In November, a lawsuit forced UNOS to alter its lung allocation policy after many years of debate.
"UNOS has, in my opinion, not explored opportunities to increase the number of organs for transplant," said Thomas M. Egan, a University of North Carolina Medical School surgeon who founded Organs for Life, another group considering a bid on the government contract. "UNOS has created a process of application for policy changes that is cumbersome and ineffective."
Egan sent a letter to HHS on Monday protesting some of the requirements of the contract proposal and threatening to take the issue to the Government Accountability Office if the agency did not "enter into a dialogue" with his group. A UNOS spokeswoman acknowledged that the government previously offered bidders 45 or 60 days to respond when contracts came up for renewal.
UNOS's revenue has risen along with the growth of organ transplantation. The current contract, its seventh, has been worth $502 million over the past 13 years, according to HRSA. The new deal would be for one year, with an option for a four-year extension.
In 2015, UNOS took in $5.9 million more than the $51.7 million it spent and reported $37.8 million in net assets or fund balances, according to the latest federal tax records available.
Its chief executive, Brian Shepard, earned more than $500,000 in salary and other compensation that year, and five other executives received more than $300,000 each.
UNOS is not sitting back in the face of possible competition. It filed a Freedom of Information Act request for the material submitted by anyone who responded to the government's "request for information" on the contract.
HHS first said it couldn't find any documents, then acknowledged turning up 50 pages but argued it was not required to turn them over. Citing exemptions in the law, the agency's FOIA office eventually agreed to release 14 pages - nine of them with UNOS's own comments. The organization responded by filing a federal lawsuit in Virginia. According to the suit, four other groups submitted comments to the government on the upcoming contract.
UNOS spokeswoman Anne Paschke said in an email that "we are working hard to put together a confidential bid that satisfies the conditions of the [Organ Procurement and Transplant Network]. UNOS is proud to have served as the OPTN and of the increase in deceased donor organs transplanted for each of the past five years."