Organ procurement organization (OPO)

An organ procurement organization (OPO) is a non-profit organization, certified by the U.S. Centers for Medicare & Medicaid Services (CMS), that is responsible for recovering deceased-donor organs within a defined geographic donation service area (DSA) and coordinating their allocation through the national transplant system.[1][2] OPOs are the operational link between donor hospitals and transplant centers: they evaluate potential donors, obtain authorization, clinically manage donors, recover organs, and arrange their placement.[3] As of the January 2026 CMS rulemaking, there are 55 OPOs in the United States, each serving a single donation service area.[4]

OPOs are not government agencies; they are private non-profit entities regulated by CMS under the Conditions for Coverage at 42 CFR Part 486, Subpart G.[1][2] Their day-to-day work is organized around the stages of deceased donation described in The donation pathway.

Legal status and regulation

OPOs operate under a federal certification and coverage framework rather than as agencies of any government. To receive payment from Medicare- and Medicaid-participating transplant hospitals, an OPO must meet the Conditions for Coverage (CfCs) codified at 42 CFR Part 486, Subpart G.[1][2] CMS designates one OPO per donation service area; historically the United States was divided into geographically exclusive DSAs, and an OPO holds an exclusive designation for its area.[1][4]

The statutory basis is the National Organ Transplant Act of 1984 (NOTA), which established the national transplant network and required OPOs to meet federal standards; the CfCs implement and update those standards.[5][1] OPOs interact closely with two other parts of the federal framework that should be distinguished from them: the Organ Procurement and Transplantation Network (OPTN), which sets allocation policy under contract to HRSA, and the hospital-side requirement that hospitals notify their OPO of every imminent death and death (42 CFR §482.45).[6]

What an OPO does

Within its donation service area an OPO carries out the deceased-donation pathway:[3]

• Referral intake and evaluation. OPO staff receive referrals from donor hospitals (mandated by 42 CFR §482.45), screen for donation potential, and conduct medical-social history and organ-specific testing.[6][3]
• Authorization. OPO family-services staff confirm first-person authorization or obtain authorization from a legally authorized surrogate under the Uniform Anatomical Gift Act.[3]
• Donor management. The OPO clinically manages the authorized donor to preserve organ function until recovery.[3]
• Recovery and placement. The OPO coordinates the recovery operation and enters the donor into the OPTN match run, arranging transport of each organ to the accepting transplant center.[3][7]
• Donor-family aftercare. OPOs provide bereavement support and facilitate donor-family/recipient correspondence.[3]

OPOs also recover ocular and other tissue, or coordinate with eye and tissue banks, although tissue banking is regulated separately (primarily by the FDA).[3]

Donation service areas

Each OPO is designated for a single, geographically defined donation service area.[1][4] DSAs were historically used both to assign donor-hospital coverage and as a unit in organ allocation; allocation policy has since moved away from DSA-based geographic boundaries toward distance-based circles for most organs, but the DSA remains the unit of OPO designation and performance measurement.[4][8]

Performance measurement and the 2020 reform (CMS-3380-F)

Concern that the historical OPO outcome measures were self-reported and not comparable led CMS to overhaul them. The final rule CMS-3380-F, "Revisions to the Outcome Measure Requirements for Organ Procurement Organizations," was issued November 20, 2020, published in the Federal Register on December 2, 2020, and took effect February 1, 2021 (with one amendment to §486.302 effective later).[8][9] The rule:[8][9]

• Replaced the prior self-reported measures with two objective outcome measures, a donation rate measure and an organ transplantation rate measure, calculated from independent data (death-certificate and transplant data) rather than OPO-reported denominators.
• Established a tiering system that ranks OPOs against each other and ties recertification and competition for DSAs to measured performance.

CMS structured the reform so that the new measures are used for recertification decisions in 2026, based on 2024 performance data (the first cycle under the new outcome measures).[8][4] As of mid-2026 this first recertification cycle is ongoing rather than complete; CMS has indicated it will publish OPO performance reports based on 2024 data in 2026, with recertification decisions following.[4] (No OPO had been decertified under the new measures as of this writing; framing should be prospective.)

CMS estimated that, if every OPO met or exceeded the donation-rate benchmark, tens of thousands of additional transplants could be performed annually.[9]

CMS-3409-P (2026 proposed rule)

A separate proposed rule, CMS-3409-P, "Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage," was published in the Federal Register on January 30, 2026, with a comment period that closed March 31, 2026.[4] This rulemaking is procedural, it addresses Conditions for Coverage provisions, and does not change the two outcome measures or the tiering established by CMS-3380-F; the two rules should not be conflated.[4][8] As of mid-2026 CMS had not finalized CMS-3409-P.[4]

Scale of activity

In 2024, the U.S. system recorded 16,988 deceased donors, which enabled 41,119 deceased-donor transplants; combined with living-donor transplants, the year set a national record of 48,149 transplants.[10][11] In 2025, preliminary figures showed more than 49,000 transplants but a roughly 2.5% decline in deceased donation (16,550 deceased donors), the first decline in deceased donation in more than a decade.[12] All such figures are point-in-time and should be re-confirmed against the cited HRSA/OPTN releases.

See also

• The donation pathway · Deceased donation
• Organ Procurement and Transplantation Network (OPTN)
• United Network for Organ Sharing (UNOS)
• HRSA Division of Transplantation
• The organ donation gap / national transplant waiting list
• Uniform Anatomical Gift Act (UAGA)

References

• eCFR. 42 CFR Part 486, Subpart G, Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-486/subpart-G
• CMS. Conditions for Coverage (CfCs) & Conditions of Participation, Spotlight (OPOs). https://www.cms.gov/medicare/health-safety-standards/conditions-coverage-participation/spotlight
• OPTN. The basic path of donation. https://optn.transplant.hrsa.gov/learn/about-donation/the-basic-path-of-donation
• Federal Register. Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage (CMS-3409-P), 91 FR 4190 (Jan. 30, 2026). https://www.federalregister.gov/documents/2026/01/30/2026-01833/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to
• National Organ Transplant Act of 1984, Pub. L. 98-507. https://www.congress.gov/bill/98th-congress/senate-bill/2048
• eCFR. 42 CFR §482.45, Condition of participation: Organ, tissue, and eye procurement. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-482/subpart-C/section-482.45
• UNOS. How we match organs. https://unos.org/transplant/how-we-match-organs/
• Federal Register. Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations (CMS-3380-F), 85 FR 77898 (Dec. 2, 2020). https://www.federalregister.gov/documents/2020/12/02/2020-26329/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to
• CMS. Fact Sheet, Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revisions to Outcome Measures for OPOs (CMS-3380-F). https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos
• HRSA. Organ Transplants Exceeded 48,000 in 2024; a 3.3 Percent Increase From the Transplants Performed in 2023. https://www.hrsa.gov/optn/news-events/news/organ-transplants-exceeded-48000-2024-33-percent-increase-transplants-performed-2023
• UNOS. U.S. surpassed 48,000 organ transplants in 2024. https://unos.org/media-resources/releases/u-s-surpassed-48000-organ-transplants-in-2024/
• UNOS. U.S. surpasses 49,000 organ transplants while deceased organ donations dip. https://unos.org/media-resources/releases/u-s-surpasses-49000-organ-transplants-while-deceased-organ-donations-dip/