CMS Finalizes Organ Procurement Organization Rule as More Than 100,000 Americans Wait for Transplants
The U.S. Department of Health and Human Services, through the Centers for Medicare & Medicaid Services (CMS), on October 30 finalized a rule to help more donated organs reach patients by strengthening oversight of Organ Procurement Organizations (OPOs), which secure authorization for donations, recover organs, and coordinate safe, timely delivery for transplantation. While more than 49,000 transplants were performed in the United States in 2025, over 100,000 Americans are waiting for lifesaving transplants, CMS said.
To improve access, the final rule allows high-performing OPOs to compete for multiple donation service areas, clarifies OPO recertification procedures, and reinforces longstanding process performance standards. It establishes clear requirements when one OPO takes over from another, strengthens oversight of unsafe practices, and changes how CMS measures transplant performance so that pancreata used only for islet cell research do not count as transplants, ensuring performance scores reflect organs transplanted into patients.
Key provisions define "unsound medical practices" to clarify when CMS may use its existing authority to immediately decertify a noncompliant OPO to protect patients; give OPOs clearer guidance to spot, investigate, and prevent adverse events; keep a donor whose pancreas is procured only for islet cell research counting toward the donation rate while removing such pancreata from the transplantation rate; require OPOs to track and record what happens to organs sent for research; require an OPO's medical director to hold a license in at least one state or territory the OPO serves; spell out decertification pathways; and codify discretionary review by the CMS Administrator of hearing officer decisions, with updated appeals timeframes. Outgoing OPOs must cooperate with incoming ones, which must submit transition plans with progress updates. The rule also removes a requirement limiting certification to OPOs recertified between 2002 and 2005.
"Every donated organ carries the chance to save a life," said HHS Secretary Robert F. Kennedy, Jr. "Under President Trump's leadership, we are holding failing organizations accountable, strengthening patient safeguards, and helping high-performing organizations reach more patients."
"Americans waiting for lifesaving transplants cannot afford poor performance by OPOs, and CMS is committed to holding these organizations accountable," said CMS Administrator Dr. Mehmet Oz, adding that the rule builds on the first Trump Administration's organ procurement reforms to promote clearer documentation, higher donation rates, and swifter consequences for bad actors.
Since CMS issued its 2020 OPO rule establishing transparent, objective performance measures, organ donations have increased by 36% nationwide and transplants by 30%, while the number of lowest-performing OPOs continues to decline, the agency said. The final rule complements HHS' recently released Kidney Care National Plan.
Source: GSM · USA
Source: GSM · USA (original Chinese edition)
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