Organ donation overhaul nears critical moment
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The troubled U.S. organ donation system is set for a pivotal series of changes as administrators begin overhauling the process for deciding which organizations work with hospitals to facilitate donations.
Why it matters: More than 100,000 Americans are waiting for transplants, and the system has been dogged by patient safety concerns, instances of inappropriate conduct and conflicts of interest among organ procurement groups.
Driving the news: The Department of Health and Human Services could shut down more than 40% of the nonprofits that obtain organs later this year and institute a competitive bidding process to replace those that lose certification.
- The aim is to boost donation and transplant rates by introducing competition into a system that's operated with monopolies for decades, with 55 organizations serving specific service areas.
- The moves come after bipartisan congressional investigations into the organ donation system and a push by the Trump administration last year to decertify a Miami contractor over unsafe practices, administrative errors and underperformance.
- The Centers for Medicare and Medicaid Services has not yet released the performance data used to certify organizations for four-year cycles.
How it works: Organ procurement organizations have been measured by criteria finalized in 2020 that include the organ donation rate and transplant rate in the service area.
- Those in the highest performance tier will automatically get recertified to serve their geographic area.
- Service areas in the middle will have to compete, and lowest-tier groups will be decertified and not allowed to compete for other open contracts.
Critics say the changes will bring more chaos to an already troubled system.
- "The uncertainty just keeps us off-kilter," said Jeffrey Trageser, president of the Association of Organ Procurement Organizations and executive director of the entity serving San Diego.
- His organization has been in the highest-performing tier, "but if OPOs all around us are decertified, it's going to destabilize the system, and that'll have impacts on us," he said.
- Transplant surgeons worry the changes will make their jobs harder, too.
- "It will absolutely disrupt our ability to provide transplants for patients," said Matthew Cooper, chief of transplantation at Froedtert Hospital and Medical College of Wisconsin.
Yes, but: The organ transplantation system isn't the model of efficiency now, with more than 103,000 people on waiting lists for organs and persistent quality and safety concerns.
- "What would you prefer — a monopoly that's been there since Madonna first broke onto the charts, or data-driven competition about who can provide the most safe transplants? It's a non-issue," said Jennifer Erickson, senior fellow for the Federation of American Scientists.
Zoom out: Organ procurement organizations and others involved in donations say the current performance metrics are unfair and unvalidated, and they're working to develop alternative measurements.
- Those would include the rates of approaches to potential donors and donations that are authorized.
What we're watching: Several of the groups have sued HHS to stop the rule from taking effect. One lawsuit filed in a Florida district court calls the policy a "hunger games approach," and argues that the rule goes against congressional intent.
- CMS has argued that procurement organizations shouldn't be able to bring a lawsuit against the policy before it's been enforced.
What's next: A final rule expected later this year will clarify the competitive bidding process. Organ procurement groups say the rule still leaves many open questions.
- HHS said it's reviewing public comments on its proposed clarifications.
