Organ Recovery Groups Face Uncertain Future as Reforms Kick In

By Tony Pugh / Bloomberg Law

September 26, 2023 12:07 pm

  • Agencies lagging in donations, transplants may lose contracts
  • Congress seeks more oversight and presses for reform

In the pre-dawn hours of August 7, tearful family members of Orlando Rios followed the gurney that carried his body down the hallways of an Albuquerque, N.M., hospital lined with mournful friends and staff.

The “honor walk” for the 28-year-old Rios marked both the tragic end of a life cut short by drug overdose and the beginning of efforts to sustain other lives through organs he donated.

Within days, New Mexico Donor Services, one of the nation’s 56 organ procurement organizations, helped arrange for an Illinois man to receive Rios’ heart. His kidneys would go to a woman in Maryland and a man in California.

Increased outreach to minorities, rising drug overdose deaths, and closer work with hospitals pushed the New Mexico agency into the top 25% of all OPOs nationwide in 2021 when it came to the number of donated organs they recovered.

But in another crucial metric—how many of those organs end up being transplanted—NDMS lagged. Its roughly 33% transplant rate on donated organs placed the organization among the nation’s lowest-performing OPOs in that category, according to the Centers for Medicare & Medicaid Services.

And if the number doesn’t quickly improve, it could be out of the organ donation business altogether.

OPOs that rank in the lowest-performing category, called Tier 3, next year face losing their exclusive federal contracts, typically worth tens of millions of dollars, in 2026. NMDS is one of 24 organizations nationwide in that danger zone, but the only one to simultaneously rank highest in one category and lowest in another.

Although the CMS has never decertified an OPO for poor performance, “that is a likely potential outcome due to these new measures” according to the rule that finalized the updated baseline metrics.

The tougher standards, and their potential to trigger mass decertifications, are the most significant developments in decades to the much-maligned process of procuring lifesaving organs for needy patients. And the situation is drawing increasing scrutiny from Congress and the Biden administration.

Some 104,000 people are on the national waiting list for an organ transplant, and 17 die every day. Another 13 fall from the list daily, too sick to survive the surgery. At the same time, researchers estimate 28,000 donated organs go unused in the US each year.

If every OPO met or exceeded the tougher CMS donation and transplant rate measures, there would be 5,600 more organs a year recovered, and transplant operations would rise from about 33,000 a year in 2018 to 41,000 by 2026, the agency estimates.

“We are not going to slow down to accommodate underperforming OPOs—tens of thousands of Americans need transplants every year, and they deserve better,” a Health and Human Services Department spokesperson said in a statement to Bloomberg Law.

The challenge of meeting the new performance metrics has created “significant concern” about what will happen next year, said Jill Grandas, executive director of the nonprofit DCI Donor Services, which operates the New Mexico agency and two other procurement organizations.

To increase their odds for more successful liver transplants, NMDS is trying to hire an abdominal surgeon who can recover livers from deceased donors, Grandas said during an interview at the group’s Albuquerque office.

Arturo Cruz, a 72-year-old Native American who has waited four years for a kidney, embodies the challenge faced by NMDS and other OPOs.

Arturo Cruz has waited four years for a kidney.

As they sat in the living room of Cruz’s small adobe home on the Ohkay Owingeh Pueblo last month, NMDS staffers could sense his frustration with the wait for an organ and his thrice-weekly dialysis treatments.

“I pray every morning for a kidney,” said Cruz, an NMDS volunteer who helps raise awareness about organ donations with Native Americans. “I still want to be here. I still have a lot to live for.”

‘Aligning’ the Mission

Cruz’s plight was a reminder that the most difficult aspect of the NMDS mission—facilitating transplants for the donated organs they’ve obtained—is also the task over which they exert the least control.

The hospitals with approved transplant centers largely decide which organs to use and who gets them. Pressure for successful transplants often lead them to reject less-than-optimal organs.

But transplant centers’ “strong regulatory disincentive” to transplant imperfect organs isn’t likely to change until the regulatory bodies overseeing the hospitals “eliminate or substantially modify the use of one-year outcomes measures in assessing” transplant centers’ performance, the American Society of Transplant Surgeons said in a 2020 letter to the CMS.

“If they’re holding OPOs to transplant as many organs as possible, then they can’t be dinging the transplant centers if they have a bad outcome when they use an organ from an older-age donor, or a more medically complex donor. That’s not aligning this whole mission that we’re under,” said Barry Massa, immediate past president of the Association of Organ Procurement Organizations, and executive director of LifeCenter Organ Donor Network, a Cincinnati OPO.

Research by Penn Medicine in 2019 found that more than 17,500 donated kidneys that US hospitals rejected over a decade would have been deemed acceptable for transplants in France.

Utilizing more high-risk organs “as do European countries” could help lead to 10,000 more transplants annually, declared a 2021 letter from the transplant surgeons association, the American Society of Transplantation, and the United Network for Organ Sharing.

Yet many feel the increased pressure to improve OPO performance is still necessary. The nonprofit agencies have faced criticism for their widely varying performance, lack of accountability, and weak federal oversight. Poor performers were seldom held accountable. In previous years, they were allowed to self-report their organ procurement and recovery rates, spurring questions about the data.

Reports of lost and misplaced organs, misuse of taxpayer funds, high salaries for OPO officials, and poor service to minorities, who are more likely to need an organ, have made OPOs a hot target for congressional reform legislation.

“From the very beginning there were laggards and there’s really never been, until now, a serious effort to address that,” said Jerold Mande, a professor of nutrition at Harvard and former congressional staffer who helped draft the 1984 legislation that defined OPOs. “Until HHS identifies, and maybe decertifies at least one or a couple of OPOs, they don’t seem to take the threat seriously. Or the system seriously.”

OPOs hold federal contracts that give them the sole authority to recover organs from deceased donors in specific regions known as “donor service areas.” They also identify potential donors, seek consent from donor families, work with other organizations to find transplant recipients and help transfer organs to transplant hospitals.

Once an OPO is decertified, other procurement organizations that meet CMS standards could compete for their service areas. If that didn’t happen, CMS would assign one or more procurement groups to take over all or part of any uncovered service area “so that no area is left without OPO representation,” the agency said.

High-performing OPOs are already anticipating the opportunity to assume new territories in 2026. But they can’t plan for that possibility until the CMS goes through the federal rulemaking process and issues guidance on how to proceed.

It’s also unclear if the time-consuming notice-and-comment rulemaking process could delay the decertifications. But critics in Congress are pressing for reforms.

“OPO reform should be an immediate priority. CMS must move decisively and ensure that the finalized rule is not weakened,” said a statement from Sen. Charles Grassley (R-Iowa).

Questions About Conflicts

The National Organ Transplant Act requires organ procurement organizations to help tissue banks retrieve, process, preserve, store, and distribute human tissue. And most OPOs have their own tissue recovery operations.

These enterprises could pose a conflict of interest by potentially creating an “incentive to pursue opportunities that are going to be lucrative,” as opposed to their primary purpose, which should be organ procurements, said Sharona Hoffman, a professor of law and bioethics at Case Western Reserve University.

But organ and tissue donation “never compete with each other” because organs must be removed first due to a limited survival time outside the body, said a statement from Colleen McCarthy, the current president of the OPO trade group.

New Mexico Donor Services conducts roughly 500 tissue recoveries a year, and is reimbursed between $150,000 to $300,000 per month for the service, according to Wayne Dunlap, its executive director. Its 90 to 100 annual organ recoveries generate reimbursements of about $1 million per month, he said.

The organization’s parent company, DCI Donor Services Inc., reported $105 million in revenue and $94 million in expenses in 2021, the last year for which its returns are public. About a third of its spending went to organ procurement.

An ongoing Senate Finance Committee investigation into possible “self-dealing” and conflicts of interest among OPO officials has also raised the stakes for the groups. Earlier this month, the committee sent inquiry letters to eight current and former board members or officials of the industry trade group, seeking information about business activity involving their individual OPOs.

Dunlap, who heads the New Mexico organization, received a letter. So did Massa, McCarthy, and an official of the Tennessee OPO that’s operated by DCI.

The senators noted that DCI owns a private transportation company, and they asked Dunlap for passenger logs for flights to see if they were billed to Medicare. The investigation of New Mexico Donor Services “and other OPOs across the country is just the tip of the iceberg when it comes to OPO misconduct,” Grassley said. “We’ll keep working to bring about real reform in the system.”

In a statement, Dunlap told Bloomberg Law: “We are cooperating with the request for information.”

Others pushed back on the criticism. “The Senate letters question the ‘legitimate business practices’ of officials who’ve dedicated decades of their lives to advancing the mission of organ donation and transplantation,” said a statement from Steve Miller, CEO of the organ procurement trade group.

Beyond the Senate probe, the possibility of decertifications continues to roil the OPO ecosystem. In a statement, the organ procurement association urged Congress “to take these concerns seriously and act now to prevent unnecessary and harmful disruption to the organ donation and transplantation system that will result from vast decertification.”

Patient advocates say OPOs should be able to improve and fend for themselves under the tougher new regulations.

“What terrifies me is not decertifying a failing OPO, but allowing it to keep its contract,” said Greg Segal, co-founder of ORGANIZE, a nonprofit patient advocacy organization. “The single most fatal aspect of the organ donation system is the lack of urgency, accountability, and professionalism at OPOs, which is exactly what decertifications will address.”

Improving OPO performance quickly can be done. Massa’s Cincinnati OPO— which is also facing Senate scrutiny—jumped from the lowest performance category in 2020 to the highest in 2021. He credited the improvement to using best practices from high-performing OPOs, shifting advertising dollars to minority outreach, and working more with transplant centers that accept imperfect organs.

Ginny McBride, executive director of OurLegacy, a high-performing OPO in east central Florida, said one fix could be to tailor the organ wait list to identify patients whose medical conditions make them the best candidates to receive less-than-optimal organs.

The CMS reimburses OPOs for their costs in helping recover and transplant kidneys for Medicare beneficiaries. For costs involving all other organs, OPOs bill the transplant centers. Congress designed the funding system to incentivize OPOs to pursue all organs, Mande said.

Getting reimbursed “regardless of performance” doesn’t “give OPOs an incentive to reallocate resources in order to increase the number of organs,” said a 2020 report by the Bridgespan Group, a consultant group that works with nonprofits. OPOs also have incentives to inflate their charges and misrepresent their expenses, said a recent report by the HHS Office of Inspector General.

President Joe Biden’s fiscal year 2024 budget asks Congress to “remove restrictions” that prevent the creation of new OPOs. Under current law, only certified OPOs can be recertified, which effectively keeps new ones from being established.

As the tumult around OPOs plays out, they’ll continue to rely on the altruism of families like Rick and Kristi Ingle of Albuquerque.

The Ingles’ daughter, Kelli, was killed in a car accident in April 2022, weeks before her scheduled graduation from Grand Canyon University in Phoenix. The Ingles knew their daughter was a registered organ donor, but didn’t know what to expect of the recovery process until staff at NMDS guided them through.

“We had a lot of people that helped us through that process that were amazing,” Rick Ingle said in an interview at the NMDS office. “It was sad, but exciting at the same time.”

“It sounds strange,” added Kristi Ingle, sitting beside her husband, “but it really gave us hope to know that she would be able to help somebody else.”

At the request of a church member, the Ingles designated Kelli’s liver for a then-31-year-old Colorado woman. She has since moved to Albuquerque, just blocks from the Ingles, and now sees them each week at Bible study.

The Ingles also hope to forge a relationship with the two women in Texas who got Kelli’s kidneys.

“We just think it would be a great experience again,” said Rick Ingle.