Federal organ donor 'reforms' proposal puts patients at risk

The Centers for Medicare & Medicaid Services' new rule for the organ donation system contains a fatal flaw, putting lives in jeopardy.

Mar. 20, 2026 at 10:03am

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A transplant surgeon warns that the Centers for Medicare & Medicaid Services' (CMS) proposed new rule for the organ donation system contains a dangerous flaw that could lead to the shutdown of more than half of the nation's nonprofit organ procurement organizations (OPOs). The metric used to rank OPOs is statistically flawed and biased against OPOs serving diverse, medically complex, and underserved communities. This could trigger disruptions to hospital contracts, donor referral systems, and trained staff, risking fewer recovered organs and fewer transplants where need is greatest.

Why it matters

The organ donation and transplant system in the US is critical for saving lives, but the proposed CMS rule threatens to destabilize this system based on a flawed performance metric. This could have severe consequences for patients waiting for transplants, especially in underserved communities. Independent research has repeatedly shown the metric to be problematic, yet Congress and CMS continue to ignore the science.

The details

The CMS proposal would rank OPOs into Tiers 1, 2, and 3, with Tier 3 OPOs facing automatic decertification and Tier 2 OPOs at risk of destabilizing competition. However, research has shown this metric is statistically flawed and biased against OPOs serving diverse, medically complex, and underserved populations. As a result, many high-performing OPOs could be wrongly penalized or shut down, disrupting hospital contracts, donor referral systems, and trained staff, ultimately reducing the number of recovered organs and transplants.

  • In January 2026, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule for the organ donation system.
  • Beginning in 2026, Tier 3 OPOs face automatic decertification, and Tier 2 OPOs can be forced into destabilizing competition.

The players

Centers for Medicare & Medicaid Services (CMS)

The federal agency that oversees the organ donation system and has proposed a new rule that contains a flawed performance metric.

Organ Procurement Organizations (OPOs)

The nonprofit organizations that run the organ donation system in the US. The proposed CMS rule threatens to shut down more than half of these OPOs based on the flawed performance metric.

Transplant surgeons and researchers

Experts who have warned for years that the metric used to rank OPOs is statistically flawed and structurally biased.

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What they’re saying

“For years, donation leaders, transplant surgeons and researchers have warned that the metric used to rank Organ Procurement Organizations (OPOs) into Tiers 1, 2 and 3 are statistically flawed and structurally biased.”

— Matthew Cooper, Transplant surgeon

“Decertification is not a paperwork exercise. It triggers disruption to hospital contracts, donor referral systems and highly trained local staff, risking fewer recovered organs and fewer transplants where need is greatest.”

— Matthew Cooper, Transplant surgeon

What’s next

Four federal lawsuits have already been filed challenging the looming decertification of Tier 2 and Tier 3 OPOs under the CMS rule.

The takeaway

The proposed CMS rule for the organ donation system is based on a flawed performance metric that threatens to disrupt the lifesaving work of nonprofit OPOs, putting patients at risk. Congress and CMS must pause implementation and align their oversight with valid, evidence-based measures to ensure the organ donation system can continue to save lives effectively.