New rules raise concern on state procuring organs
New federal standards threaten to disrupt organ procurement in Arkansas, shaking up nonprofits that secure kidneys, livers and more for patients who need transplants.
Two of four organ procurement organizations working in Arkansas ranked in the lowest “tier” of performers nationally — roughly, in the bottom third — if graded under the new guidelines that take effect in 2022, sample data released by regulators show.
Groups that don’t meet new benchmarks by 2026 will lose contracts with the government — terminations that experts say are unprecedented. Other organ procurement nonprofits would then bid to take over decertified groups’ areas.
The local groups that lagged their peers are Arkansas Regional Organ Recovery Agency, known as ARORA, covering 64 of the state’s 75 counties, and Mid-South Transplant Foundation, a Memphis group active in six eastern Arkansas counties.
ARORA had the sixthworst and Mid-South the worst transplantation rates in the country, according to a chart included with the new Centers for Medicare and Medicaid Services policies. The documents didn’t provide a detailed analysis of each group’s performance.
For 2018, ARORA needed to have placed at least 25 additional organs and Mid-South Transplant Foundation
at least 109 to reach the median transplantation rate, the chart shows.
Both groups declined interview requests to discuss the new standards. A MidSouth Transplant Foundation spokeswoman said the group is reviewing the criteria and works “every day to promote donation and implement improvement measures to increase donors.”
ARORA’s director said in a statement that the group supports improvements to the transplant system, but was “disappointed” by the new regulations, finalized in November.
They failed “to address most of our concerns with the flaws in the design of the new metrics, including the use of death certificates — frequently found to be inaccurate — to verify important [organ procurement organization] data,” Director Alan Cochran said.
Federal health officials spelled out the new standards in a 208-page document that used 2018 data to show how the country’s 57 organ procurement groups might fare.
The rules assess donation rates — how many donors successfully gave an organ — and transplantation rates, which measure how many organs are transplanted as a percentage of possible donors.
That’s more “objective and verifiable” and less reliant on self-reported data from nonprofits, the government said. Data will be made public, and the government will stop working with nonprofits that don’t measure up.
The documents show that ARORA and Mid-South Transplant Foundation ranked alongside performers whose contracts could be jeopardized under the standards.
Experts and advocates say the new rules will phase out groups that aren’t as effective in pursuing organs for more than 100,000 people on the national transplant waiting list. Critics say decertifying groups will sow chaos in a complex system.
Fresh guidelines for organ procurement groups are “long overdue,” said Dr. James D. Eason, transplant surgery division chief at the University of Tennessee Health Sciences Center and director of an eponymous transplant center at Methodist University Hospital in Memphis.
When those organizations don’t excel, “the ramifications of that are that patients are dying,” he said.
The effects of local groups’ performance aren’t limited to Arkansas patients, because organs travel across state lines. The groups that get fewer organs drag on the whole system, critics say.
Two other organizations active in Arkansas, Mid-America Transplant Services and Southwest Transplant Alliance, did better in sample rankings. Mid-America Transplant Services works in five northeastern counties and Southwest Transplant Alliance is in Miller County.
The new criteria encourage groups to aggressively pursue organs, said Kevin Lee, chief organ operations officer at Mid-America Transplant Services, active in Clay, Craighead, Greene, Independence and Lawrence counties.
“Can you, as an organization, look at yourself in the mirror and say ‘I’m doing everything, each and every day, to take somebody in my community … off the waiting list?’ That’s the impetus behind the rule,” he said.
‘A FULLER LIFE’
Health experts estimate about 20 people nationally die every day waiting for an organ transplant. Public and private entities — including hospitals, transplant centers and organ procurement organizations — work together to oversee donation and transplant processes.
But some research argues that thousands of viable organs are never obtained, or are discarded after surgeries to recover them. A 2017 report from the Bridgespan Group consulting firm estimates that the U.S. could recover as many as 28,000 additional organs each year.
That’s in part, researchers wrote, because organ procurement organizations’ performance varies more than local donor demographics predict. A “monopoly”-like contract structure — which assigns just one organ procurement group to each region — and other regulations didn’t create incentives to improve, they said.
By updating standards for the groups and culling bad performers, the new rules aim to boost the organ supply, offering patients “a fuller life untethered from dialysis machines and waiting lists,” CMS chief Seema Verma said in a statement.
Response from the organ procurement organization industry has been mixed, representatives said.
Kyle Herber, president and chief executive of highly ranked Live On Nebraska, praised the rules as a step in the right direction, though he cautioned that the highest rankings could be unattainable for peers.
To potentially have a dozen or more organ procurement groups leave the system at once is a concern, he said.
“What we need to make sure is there is no impact to those on the waiting list, and those that are waiting continue to get the organs they need in a timely manner,” he added.
The trade and lobbying group representing organ procurement organizations will meet with regulators to understand the policy, and the new presidential administration may “tweak” things, Association of Organ Procurement Organizations chief executive officer Steve Miller said.
Advocacy group Organize hailed the changes in a statement, saying the organ supply will benefit patients of color, who are both more likely to need organ transplants and less likely to receive organs.
The group criticized the rules’ long implementation timeline, which it said will cost thousands of lives before the first groups lose contracts in five years.
‘HIGHLY SENSITIVE’
Local stakeholders said the guidelines’ impact won’t be known for some time, but they shared possible concerns.
Joy Cope, nursing director for the solid organ transplant department at University of Arkansas for Medical Sciences, said a mass shutdown of organ procurement groups will challenge transplant programs that have relationships with those groups.
Organ donation is a “highly sensitive, compassionate” process, she said. “Were it to happen that we lost ARORA, we would need to have somebody on the ground working within our community, that knows our people.”
Arkansas Donor Family Council President Tammy Sisemore, whose son became an organ donor when he died in a car accident, said she’s concerned about a disruptive transition if any of the state’s organ procurement organizations can’t continue.
“I think you would lose donors,” she said.
Others said the guidelines represent an opportunity for organ procurement organizations to improve practices. That might look like pursuing older donors, cultivating hospital relationships and going after donors with just one viable organ, said Lee, the official active in Northeast Arkansas.
Jan Finn, president and CEO of the Midwest Transplant Network organ procurement organization active in Kansas and Missouri, said the guidelines just represent “a little bit of a different process.” She said organ procurement is a highly specialized field, and it takes practice to do the work well.
That includes expertise with donor families, whom they meet “at their worst moments,” she said.
The documents show that ARORA and Mid-South Transplant Foundation ranked alongside performers whose contracts could be jeopardized under the standards.