FORT WAYNE, Ind. — A federal overhaul of the nation’s organ donation system, rooted in President Trump’s 2020 executive order, is moving forward. The Centers for Medicare and Medicaid Services (CMS) will soon evaluate all 55 organ procurement organizations (OPOs) using stricter performance metrics tied to donation and transplantation rates.
Tiered Certification to Strengthen the System
Under the revised framework, OPOs will be placed into three tiers. The top 25 percent will automatically receive a new four‑year certification, ensuring continued federal contracts. Mid‑tier groups will be given a chance to improve and reapply, while those in the bottom tier will lose certification and federal funding.
CMS plans to begin the certification process early next year, with contract extensions available to prevent any interruption in transplant services. The agency says the approach is “transparent, data‑driven, and focused on saving more lives through organ donation.”
Broad Support from Medical Community
Medical professionals and patient‑advocacy groups have praised the move, arguing that stronger oversight is essential for a system that serves over 109,000 patients on waiting lists nationwide. The American Society of Transplant Surgeons called the changes “long overdue,” noting a recent decertification in Miami as a positive precedent.
Jeff Trageser, immediate past president of the Association of Organ Procurement Organizations, said accountability is vital, but cautioned that transplant rates can be affected by factors beyond an OPO’s control, such as decisions made by transplant centers.
Legal Challenges and Concerns
Several OPOs have filed lawsuits contesting the new rules, arguing that forced competition could destabilize the organ donation network. A Hawaii‑based OPO sued to block the evaluation system, while groups in California, Florida, Georgia, Iowa, Puerto Rico, Texas, and Washington have also challenged the approach. A federal district court in Florida upheld the rule, and the plaintiffs are now appealing.
Critics worry that decertifying organizations could disrupt established relationships with donor families and communities, especially in areas of color that already harbor distrust of the medical system. Dr. J. Thomas Rosenthal of OneLegacy emphasized that trust is “the key factor in everything we do.”
Balancing Accountability with Community Trust
Patient‑advocacy leader Greg Segal countered that preserving underperforming OPOs on the basis of community ties would undermine accountability. “Organizations that consistently deliver poor results should not be allowed to use disruption concerns as a shield against improvement,” he said.
The CMS estimate that up to 42 percent of OPOs could fall into the lowest tier underscores the scale of the reform. If an OPO is decertified, other nonprofits may compete for the federal contract to serve that geographic area, potentially raising overall performance.
Looking Ahead
The Trump administration’s focus on data‑driven health policy continues to shape federal initiatives that protect patients and families. By tying certification to measurable outcomes, the CMS rule aims to ensure that every organ donation opportunity translates into a life‑saving transplant.
CMS has not yet announced which specific OPOs will retain their contracts. The agency expects to release certification decisions later this year, with the process slated to begin in early 2027.
Original reporting: WOWO News/Talk (Fort Wayne) — read the source article.
