ABSTRACT
Introduction
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). Hospitals can apply for waivers to work with a different OPO with appropriate justification. We sought to evaluate the impact of hospital waivers on organ donation activity.
Methods
We evaluated Organ Procurement and Transplantation Network (OPTN) data from two OPOs (Donor Network West and Honor Bridge), each with a 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. 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, mean monthly donors at intervention hospitals increased from 5.6 pre‐waiver to 7.9 post‐waiver, while control hospitals remained stable (56.6 vs. 57.5 donors/month). Mean monthly organs transplanted increased from 16.5 to 24.9 at intervention hospitals, while control hospitals were unchanged (170.9 vs. 169.3 organs/month). The difference‐in‐differences interaction term was statistically significant for both donors recovered (p < 0.1) and organs transplanted (p < 0.1). Reported deaths were stable in both groups.
Conclusion
With eight months of post‐waiver data, 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.
Abbreviations
- CMS
Centers for Medicare and Medicaid Services
- DID
Difference‐in‐differences
- DSA
Donation service areas
- CADN
Donor Network West
- NCNC
Honor Bridge
- NCCM
LifeShare Carolinas
- NVLV
Nevada Donor Network
- OPO
Organ procurement organization
1. Introduction
The approval of a new Centers for Medicare and Medicaid Services (CMS) organ procurement organization (OPO) final rule in 2020 led to increased oversight and monitoring of OPO performance [1]. Beginning with the 2026 certification cycle, this rule will allow the highest‐performing organ procurement organizations (Tier 1) to compete for donor hospitals in other OPOs’ service areas, a change pending implementation later in 2026. However, there is also a pathway by which a donor hospital can request a CMS waiver to work with an OPO other than its designated OPO provided the waiver is expected to increase organ donation [2]. The waiver pathway has rarely been requested until recently [3, 4, 5]. Concerns have been raised that waivers and changes in donor hospital affiliations could negatively impact organ donation by ending longstanding donor hospital‐OPO relationships. However, there are no empiric data to support this.
In April 2025, two large hospitals, Renown Regional Medical Center in Nevada and North Carolina Baptist Hospital changed OPO affiliations after being granted CMS waivers. Renown Regional Medical Center realigned from Donor Network West (CADN) to Nevada Donor Network (NVLV) and North Carolina Baptist Hospital from Honor Bridge (NCNC) to LifeShare Carolinas (NCCM). Both waiver requests were made, and granted, because each of these hospitals sought to affiliate with OPOs with higher performance based on the CMS OPO metric, and therefore greater potential to increase donation activities at their respective hospitals [6, 7]. Based on CMS's 2023 OPO Annual Public Aggregated Performance Report, Renown Medical Center was allowed to switch affiliations from a Tier 2 OPO (CADN) to a Tier 1 OPO (NVLV), and North Carolina Baptist to switch affiliations from a Tier 3 OPO (NCNC) to a Tier 1 OPO (NCCM) [8]. Both realignments were subsequently met with legal challenges, and recently, several other waiver applications, all seeking to switch affiliations to NCCM [9, 10, 11, 12, 13, 14, 15].
Concerns about the granting of waivers, along with the prospect of increased competition and donor hospitals switching affiliations after the 2026 OPO certification cycle has magnified the need to empirically study the impact of donor hospitals realigning with different OPOs.
2. Methods
We evaluated Organ Procurement and Transplantation Network (OPTN) data from 8/1/2024–11/30/2025 to ensure equal time pre‐ versus post‐waivers. Within each DSA, the OPTN provided monthly aggregate data per donor hospital on deaths reported to the OPO (and reported to the OPTN), donors recovered, and organs transplanted. We focused on two OPOs (CADN and NCNC) to compare organ donation activity at the hospitals that maintained their affiliation (i.e., “control”) to the two hospitals that changed OPO affiliation (i.e., “intervention”). No washout period was used for the first month of transition. Control hospitals included all other donor hospitals within the DSAs of CADN and NCNC (n = 115); intervention hospitals were Renown Regional Medical Center and North Carolina Baptist Hospital (n = 2). Renown Regional Medical Center is an 808‐bed, Level II trauma center while North Carolina Baptist Hospital is a 921‐bed, Level I trauma center and academic medical center.
2.1. Statistical Analyses
We employed a difference‐in‐differences (DID) analytic framework to evaluate the association between hospitals changing OPO affiliation and hospital‐level donor activity [16, 17]. This approach allowed us to estimate the causal impact of an intervention (hospitals switching OPO affiliations) by comparing the change in outcomes (monthly donors recovered and organs transplanted) between treatment group (hospitals switching affiliations) and control group (hospitals maintaining affiliation).
The primary outcomes were monthly: (a) donors recovered; and (b) organs transplanted. We fit multilevel mixed‐effects models with random intercepts for each hospital to account for differences in baseline outcomes for each hospital and to account for within‐hospital correlations. Models included the covariate of calendar month, a variable for era pre‐post OPO waiver implementation (8/1/2024–3/31/2025 versus 4/1/2025–11/30/2025), and an interaction term between waiver implementation period and control versus intervention hospital. This interaction term represented the DID estimator and signified whether donor hospitals changing OPO affiliations were associated with a difference in organ donation activity. A p‐value of < 0.1 was considered statistically significant for the interaction term [16, 17].
This study was considered exempt from Institutional Review Board review.
3. Results
3.1. Donors Recovered
The mean number of monthly donors recovered at control hospitals was unchanged in the post‐waiver period: 56.6 ± 8.6 versus 57.5 ± 12.1 (Figure 1a). In contrast, mean monthly donors increased at intervention hospitals after switching OPO affiliations (5.6 ± 2.2 pre‐waiver vs. 7.9 ± 3.9 post‐waiver), which was statistically significant (difference‐in‐differences estimate + 1.1 donors/month, p = 0.003; i.e., intervention hospitals gained approximately 1.1 more donors per month than expected from the control hospitals’ trend). These increases were evident at both intervention hospitals: (a) Renown Regional Medical Center: 2.9 ± 2.0 increased to 3.4 ± 3.2; b) North Carolina Baptist Hospital: 2.8 ± 1.2 increased to 4.5 ± 2.1.
FIGURE 1.
(four panels): Box and whisker plots of monthly organ donation activity at control and intervention hospitals in the two analyzed donation service areas from 8/1/2024–11/30/2025. a: Donors recovered. b: Organs transplanted. c: Organs transplanted per donor. d: Deaths reported by donor hospitals to the Organ Procurement and Transplantation Network. *Note: The intervention hospitals are Renown Regional Medical Center and North Carolina Baptist Hospital which were each granted a waiver to work with a different OPO. The control hospitals are all other donor hospitals within the DSA of Donor Network West and Honor Bridge (n = 115 control hospitals; n = 2 intervention hospitals). Each panel is a box‐and‐whisker plot showing the distribution of monthly values for the pre‐waiver (8/1/2024–3/31/2025) and post‐waiver (4/1/2025–11/30/2025) periods, shown separately for control and intervention hospitals; boxes denote the interquartile range, the central line the median, the whiskers the range, and points individual outlying months. Deaths reported not available for November 2025 for all hospitals so it was excluded. Note that aggregate counts reflect group size differences (115 vs. 2 hospitals); the difference‐in‐differences analysis compares trends over time rather than absolute levels. Month‐to‐month variation is expected given the aggregate nature of the data and is accounted for in the mixed‐effects models.
3.2. Organs Transplanted
The mean number of organs transplanted per month at control hospitals was unchanged in the post‐waiver period (170.9 ± 38.0 pre‐waiver vs. 169.3 ± 39.0 post‐waiver) but increased significantly at the intervention hospitals (16.5 ± 8.1 pre‐waiver vs. 24.9 ± 15.4 post‐waiver (difference‐in‐differences estimate + 4.3 organs/month, p = 0.002); Figure 1b). Changes were similar at both intervention hospitals: (a) Renown Regional Medical Center: 9.3 ± 7.2 increased to 12.1 ± 11.8; (b) North Carolina Baptist Hospital: 7.3 ± 3.2 increased to 12.8 ± 6.5.
Overall mean number of organs transplanted per donor was stable at control hospitals but numerically increased at intervention hospitals overall (Figure 1c), but the difference was not statistically significant (difference‐in‐differences interaction p = 0.53).
3.3. Reported Deaths
Despite month‐to‐month fluctuation in the number of reported deaths, the mean number of reported deaths did not significantly increase at intervention hospitals (difference‐in‐difference p = 0.23), and was overall stable at both control and intervention hospitals (Figure 1d)
3.4. Donation Rates
Monthly donation rates (donors recovered / reported deaths) were stable at control hospitals pre‐ to post‐waiver (mean 2.8% ± 0.3% vs. 3.1% ± 0.5%) but increased markedly at intervention hospitals (mean 2.5% ± 1.0% vs. 4.4% ± 2.2%), consistent with the absolute donor counts (Figure 2).
FIGURE 2.
Box and whisker plots of pre‐ and post‐waiver monthly donation rates (donors recovered / reported deaths) at control and intervention hospitals.
4. DISCUSSION
We demonstrate that in the short‐term period after two large hospitals changed OPO affiliations, there were significant increases in the number of donors recovered and organs transplanted despite an unchanged number of reported deaths. These data suggest that donor hospital waivers are not associated with worsening short‐term donation activity. Broader testing and longer‐term data are needed to determine whether waivers meaningfully and durably improve donation activity across heterogeneous hospitals and OPOs.
Previous studies have demonstrated that data‐driven performance improvement initiatives can lead to a rapid and significant increase in organ donation [18]. Furthermore, there are data to demonstrate that while OPO leadership changes do not guarantee improvements in organ donation, they significantly increase the odds of rapid improvement [19]. Our short‐term data suggest that granting of waivers may increase donation activity at individual hospitals following a change in OPO affiliation. However, we acknowledge that contemporaneous changes (e.g., increased media attention, hospital staff awareness) could contribute to observed improvements, and our data need to be confirmed with longer‐term data across a broader range of hospitals and OPOs.
To explore potential mechanisms by which a donor hospital changing OPO affiliations could be associated with changes in donor activity, we communicated with leadership from LifeShare Carolinas. Several changes in practice were identified: (1) LifeShare and North Carolina Baptist Hospital created leadership committees to address areas where donation processes were inefficient; (2) LifeShare clinical, family services, and hospital development staff are onsite and available to hospital staff on a daily basis; (3) LifeShare implemented electronic referrals and communication between OPO and donor hospital staff using Epic Secure Chat; and (4) LifeShare invested heavily in their Family Services division, with additional investments in preparation for adding a donor hospital. Nevada Donor Network was not able to comment due to ongoing legal matters.
The data we present from these two OPOs help to explain how these rapid improvements can occur. OPOs have heterogeneous practices, and higher‐performing OPOs may implement changes that are specific to the new donor hospital, or broadly implemented across the OPO, that provide an opportunity for marked and immediate improvements in organ donation. It is also possible that the new OPO benefited from infrastructure, clinical relationships, and donor family engagement workflows established by the prior OPO during its tenure at the hospital. Disentangling the contributions of the OPO transition itself versus residual effects of the prior OPO's work is beyond the scope of this analysis but represents an important area for future research. Both intervention hospitals in our study are large academic or high‐volume centers, and it remains unclear whether findings would generalize to smaller or more rural hospitals.
Our study did have limitations. First, with only two intervention hospitals, our findings may not generalize to all donor hospital–OPO transitions. Second, the difference‐in‐differences framework requires assumptions of parallel pre‐intervention trends and no common shocks; we did not formally test for parallel trends, and contemporaneous events could confound our results. Third, observed improvements may not be durable over time. Fourth, OPTN data are aggregated at the hospital level, precluding inclusion of donor‐level covariates. The OPTN data were also not disaggregated by organ type, so we could not determine whether the increase in organs transplanted was driven by particular organs. Fifth, it is possible that infrastructure developed by the prior OPO contributed to early improvements observed under the new OPO.
Longer‐term data are needed to evaluate the durability of these improvements, and whether they always occur when there is a change in affiliation of a donor hospital and an OPO. Nevertheless, these data are time‐sensitive and vital to the transplant and donation community, and government regulators in light of the 2026 OPO certification cycle and the potential for future donor hospital waiver requests to CMS. In addition, these data underscore that donor hospital acquisitions may have the potential to improve organ donation and should lead CMS to consider future waivers based on these encouraging preliminary data.
Author Contributions
Isabella Sharifi: Study conceptualization, data analysis, drafting of manuscript, approval of final manuscript. Erin Tewksbury: Study conceptualization, data analysis, approval of final manuscript. Matthew Wadsworth: Study conceptualization, data analysis, drafting of manuscript, approval of final manuscript. David S. Goldberg: Study conceptualization, data analysis, drafting of manuscript, approval of final manuscript.
Funding
There was no funding for this work.
Conflicts of Interest
The authors declare no conflicts of interest.
Acknowledgments
This work was supported in part by Health Resources and Services Administration contract HHSH250‐2019‐00001C. The content is the responsibility of the authors alone and does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government. We would like to thank 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. Matthew Wadsworth and Erin Tewksbury are both employees of LifeConnection of Ohio. Dr. Goldberg is a physician scientist at the University of Miami who received funding for research from ORGANIZE to develop new metrics of OPO performance in 2016‐2017.
Data Availability Statement
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. Data sharing not available per the DUA from the OPTN.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
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. Data sharing not available per the DUA from the OPTN.