CMS Finalizes Its Organ Procurement Rule. The Declaration of Death Stays With the Hospital Physician.
The Oct. 30 rule defines the unsound practices that let CMS decertify an organ procurement organization at once and stops counting research pancreata.
The Centers for Medicare and Medicaid Services (CMS) on Oct. 30 finalized a rule that defines when it can immediately decertify an organ procurement organization (OPO) for "unsound medical practices" and changes how transplants are counted.
OPOs are the federally certified organizations that obtain consent for donation, recover organs and coordinate delivery to transplant programs. The final rule (CMS-3409-F) is scheduled for Federal Register publication on Nov. 3 and takes effect 60 days later, on Jan. 2, 2027, by our count. It builds on the 2020 rule that ranks OPOs in three tiers by donation and transplantation rates. CMS left those measures and tiers unchanged.
What did CMS finalize?
The rule defines unsound medical practices, lets high-performing OPOs compete for more than one donation service area, sets rules for handing a territory from one OPO to another and spells out decertification pathways. Under the definition, unsound medical practices are OPO failures that create an imminent threat to patient health and safety or a risk to patients or the public, including failures in governance, donor evaluation and management, and procurement, allocation and transport. The CMS fact sheet lists the other changes. Each OPO's medical director must be licensed in at least one state or territory the OPO serves, and OPOs must document what happens to organs recovered for research.
The rule also removes the requirement that limited certification to OPOs recertified between 2002 and 2005. CMS now says the law lets it certify entirely new OPOs. The process for doing that is left to future rulemaking.
What does it say about physicians and the declaration of death?
CMS states that the decision to withdraw life support and any declaration of death belong solely to the patient's attending physician or a hospital physician designee, under hospital policy and state law. OPOs may not take part in the decision to withdraw, its timing or the declaration. They must verify and document that death was pronounced before recovery begins, including in donation after circulatory death.
The rule adds a line ICU and emergency teams will notice. OPOs must stop procurement immediately if signs of life appear at any point, and a prior declaration does not authorize them to continue. Commenters had objected that an example in the proposal, "pursuing patients with inappropriately high neurologic function," had no clinical definition. CMS replied that the examples are illustrative and do not set neurologic thresholds or replace clinical judgment, and it said surveyor guidance will follow.
The rule draws the line in writing: the hospital physician decides and declares, and the OPO verifies and stops if anything changes.
How do the transplant numbers change?
Pancreata recovered only for islet cell research will no longer count toward an OPO's transplantation rate, though the donor still counts toward its donation rate. The change applies from the 2027 assessment period. CMS will recalculate the 2026 median and top-quartile thresholds without those pancreata, so the comparison in the 2029 public performance report uses like data. CMS says the 2022 to 2026 recertification cycle is already complete and the new rule will not delay enforcement decisions for it.
CMS also points to its own numbers. More than 49,000 transplants were performed in the United States in 2025, more than 100,000 people are waiting, and donations are up 36 percent and transplants 30 percent since the 2020 rule. Those figures come from the agency, and it did not say what share of the gain comes from the rule itself.
What it means for hospitals and transplant teams
Donor hospitals should check that their written OPO agreements and donation after circulatory death policies match the rule's language: the physician owns the death determination, the OPO verifies it, and any sign of life stops recovery. Transplant programs in areas served by tier 2 or tier 3 OPOs should expect territory changes and should read the transition-plan requirements. The rule complements HHS's kidney strategy, which we covered in the National Kidney Care Plan's 23 recommendations. It is also the latest example of CMS using direct enforcement levers, after it gained the power to exclude physicians from Medicare and Medicaid in October.
Reported, fact-checked and edited by The Script Pad's editorial staff. See How we use AI.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
