ABSTRACT

Importance Donor hospitals in the United States are assigned to a designated organ procurement organization (OPO) responsible for managing deceased donors in the designated donation service area (DSA). Donor hospitals can apply for waivers to work with a different OPO with appropriate justification, and beginning with the 2026 OPO certification cycle, the highest-performing OPOs can bid to work with donor hospitals managed by intermediate- and low-performing OPOs.

Objective We sought to evaluate the impact of donor hospital waivers on organ donation activity.

Design Retrospective cohort study.

Setting We evaluated Organ Procurement and Transplantation Network (OPTN) data from two OPOs (Donor Network West and Honor Bridge), each with a donor hospital (Renown Regional Medical Center and North Carolina Baptist Hospital) in its DSA granted a waiver to work with a different OPO beginning in April 2025.

Main Outcome We assessed changes in the number of organ donors and organs transplanted pre- and post-granting of a waiver using a difference-in-differences approach based on multilevel mixed-effects models.

Results After switching OPO affiliations, these two donor hospitals had marked and statistically significant increases in the number of donors recovered and organs transplanted, despite stable numbers of reported deaths at each hospital. In multivariable models, switching OPO affiliations was associated with a statistically significant increase in donors recovered and organs transplanted. Conclusion: With eight months of post-waiver data, donor hospitals with granted waivers had significant increases in donation activity driven by improved donor conversion rather than changes in referral patterns or organ yield per donor. Although longer-term data are needed to confirm these findings, CMS and the organ transplant community should feel confident that changing donor hospital-OPO affiliations will not negatively impact donation and may lead to significant increases in donation. These data also counter unfounded concerns that the continued granting of waivers and realignments of donor hospital-OPO affiliations during the 2026 recertification cycle will lead to a collapse of the system of organ donation.

Question Do donor hospitals who request a waiver to change OPO affiliations have changes in organ donation rates?

Findings Using a difference-in-difference approach, the two donor hospitals who changed OPO affiliations had a significant increase in organ donors and organs transplanted after being granted a waiver.

Meaning Donor hospitals that change OPO affiliations have an immediate increase in organ donation activity.

Competing Interest Statement

Michael Daniels, Executive Director of LifeShare Carolinas and Dr. Michael Haley, Medical Director of LifeShare Carolinas for providing process-level information related to changes in donor management after North Carolina Baptist Hospital began to work with their OPO. Michael Daniels and Dr. Michael Haley reviewed the manuscript to ensure the information related to changes in practices at North Carolina Baptist Hospital were accurate, but they did not provide input on the OPTN data analyses or the conclusions of the manuscripts.

Funding Statement

This study did not receive any funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

The raw and aggregated data cannot be shared as per the data use agreements of the OPTN, but if an investigator obtains the data we can share our underlying source code.

Abbreviations(CMS)Centers for Medicare and Medicaid Services(OPO)Organ procurement organization(DSA)Donation service areas(CADN)Donor Network West(NVLV)Nevada Donor Network(NCNC)Honor Bridge(NCCM)LifeShare Carolinas(DID)Difference-in-differences