This measure is the rate per 100 deaths of ventilated hospital referrals to the OPO of potential donor population in the OPO’s Donation Service Area (DSA) within a calendar year.
Measure Specs
General Information
This measure is the rate per 100 deaths of ventilated hospital referrals to the Organ Procurement Organization (OPO) of the potential donor population in the OPO’s donation service area (DSA) within a calendar year. We will refer to this measure as the Referral Rate measure in this report. The goal of this measure is to provide OPOs with data that will enable them to improve their referral process. While all OPOs count their referrals, they do not all do so in a standardized manner. An improved referral process and standardized way of counting referrals will help achieve the ultimate goal of increasing the number of viable organs available for transplant that are offered to transplant centers.
A hospital’s referral of a potential organ donor is the starting point of OPO procurement activity. For a referral to take place, it requires that donor hospital staff understand appropriate clinical triggers, recognize when organ donation is a possibility, and notify the OPO. It is also important that hospitals not over refer individuals who do not meet triggers, as over-referral uses valuable OPO resources. Timely referrals from hospitals are integral in helping ensure that OPOs have sufficient time to assess medical suitability of the potential donor and facilitate adequate time for appropriate conversations with the donor or next of kin. When referral data are broken down by race, gender, and hospital, they can also provide insight into potential bias and hospital participation.
Referral Rate data are valuable for informing quality improvement efforts in education and outreach for hospital staff. Optimization of referral rates can ultimately lead to more organs being available for transplantation, thereby reducing the number of deaths on the organ transplant waiting list. Ongoing relationships between OPO and hospital staff encourage future referrals and organ donation prospects.
Reporting of this measure will enable increased OPO accountability for ensuring effective hospital engagement, which is a primary factor in promoting timely referrals. When OPOs are effectively engaging with the hospitals in their DSA, hospital staff receive training on clinical markers of imminent death, information covering the roles and activity of the OPO staff, and the steps in the organ procurement and transplant process. Additionally, hospital staff are provided with reference resources (e.g., tip sheets) and have regular face-to-face encounters with OPO coordinators who facilitate connections between the hospital and OPO. Collaboration between hospitals and OPO staff creates partnerships in providing patient care and increases the likelihood of organ donation referrals.
Gibson et al. (2023) demonstrated the importance of relationship and collaboration between donor hospitals and OPOs. After reviewing suboptimal donation metrics with their OPO hospital liaison, they implemented a multidisciplinary performance improvement initiative to create a more donation-friendly culture in their facility. Hospital administrative engagement, staff education, and increased OPO program visibility were key approaches used. Their efforts to improve staff understanding and awareness of organ donation changed referral and compliance patterns, with demonstrated improvements in donation metrics. The relationship between OPOs and donor hospitals is a vital link in the organ donation continuum.
Reference:
Gibson, J. E., Campbell, T., Gibson, K., Kottemann, K., Krause, M. A., & Pack, L. (2023, June 15). Collaborative approach to organ donation in a level II trauma center. AACN Adv Crit Care, 34(2), 88–94. doi: 10.4037/aacnacc2023552.
Referrals are made to the OPO staff while onsite at the donor hospital, by telephone through a call center, or via electronic submission directly into the OPO’s EDR. Of our six OPO test sites, four used LifeLogics/TrueNorth EDR and two used iTransplant/InVita Health EDR. Both systems permit data capture via an application programming interface (API) linked to hospital EHRs—where available and in coordination with donor hospitals—for the input of patient data, including demographic and clinical data. OPOs routinely report donor information as part of regulatory requirements, and data for this Referral Rate measure would be captured through similar mechanisms and procedures.
Many OPOs take advantage of electronic referral tools, while some OPOs rely on manual data entry from phone-based referrals with standardized quality assurance (QA) checks. To address these challenges, OPOs utilize APIs (such as iTransplant’s Referral API) to connect with hospital EHR systems or through repeated outreach to the donor hospitals. In some cases, smaller hospitals do not have the infrastructure, capacity, or resources to integrate an API into their older EHRs or to provide all of the data electronically to the OPO. OPOs emphasized maintaining strong points of contact at each hospital within their DSA to foster these data exchanges.
The data for the numerator of the Referral Rate measure comes from structured data fields contained in OPO EDRs. Prior to measure testing, we discussed the nature of the variables with OPOs to understand the data elements and workflows that generated the data points. Through reviews of OPO data, their dictionaries, the logic behind calculated fields, and—in some cases—additional data submissions, we learned how each OPO captured and reported their data. We then engaged in discussions with each OPO to ensure that we obtained and analyzed the necessary data based on the measure specifications and definitions. Other clarifications included alignment on how missing data were handled. For measure implementation, the variable definitions, data capture protocols, QA, and auditing procedures will be communicated across OPOs to align these data elements in a systematic way.
The data for the denominator of the Referral Rate measure came from the MCOD data from NCHS and NVSS. These data were well-structured, defined, and cleaned and presented no feasibility, reliability, and/or validity challenges for the analysis.
Numerator
The numerator is the number of ventilated patients in the OPO’s DSA referred to the OPO in a calendar year, regardless of whether a donation actually resulted from the referral.
The numerator for the Referral Rate measure uses data shared directly by six OPOs. The numerator is the number of ventilated patients in the OPO’s DSA referred to the OPO in a calendar year, regardless of whether a donation resulted from the referral. The OPO receives telephonic or electronic notification by a donor hospital of a potential donor based on clinical criteria agreed upon between the OPO and the donor hospital in a Memorandum of Understanding (MOU). OPOs maintain MOUs with donor hospitals regarding hospital notification of imminent deaths. These MOUs are specific to each hospital and generally require hospitals to make referrals within 1 to 3 hours of a ventilated patient meeting any of the following established clinical triggers and prior to the withdrawal of mechanical and/or pharmacological support:
- Patient with a neurological and/or life-threatening injury.
- Loss of neurological function without sedation.
- Patient meeting a Glasgow Coma Scale (GCS) of 5 or less.
- Anticipated family meeting to discuss end-of-life care.
- Prior to the discontinuation of ventilator support, the family asks to discuss donation options.
A referral is attributed to a calendar year based on the date of the referral, not the date of death. Referred potential donors are counted as referrals regardless of whether the referral was made using accurate clinical criteria for donation (donor referral triggers).
A potential donor is a hospitalized patient who meets the following clinical criteria for donation:
- Brain death or imminent death from severe brain injury or trauma, cerebrovascular insult, anoxic injury, or amyotrophic lateral sclerosis; or
- Assist-device dependent (e.g., extracorporeal membrane oxygenation (ECMO); or
- Referred as outlined in each OPO-to-hospital MOU, as outlined above.
The potential donors are included in the numerator regardless of whether the referral resulted in an organ transplant into a recipient. Referrals are attributed to the calendar year (time between 12:00 a.m. on January 1 of a calendar year and 11:59 p.m. on December 31 of that same year) based on the referral date.
OPOs capture the ventilator status in their Electronic Donor Record (EDR) at the time of referral from the donor hospital.
Please refer to Attachment B for a list of definitions and acronyms associated with this measure submission.
Denominator
The denominator is the number of the potential donor population in the OPO’s DSA in the calendar year.
The denominator uses the National Vital Statistics System (NVSS) Multiple Cause of Death (MCOD) data, which are mapped by county in the OPO’s DSA. The NVSS MCOD data are compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. Potential donors are then apportioned to OPOs in counties with a waiver hospital based on the percentages calculated by CMS in their OPO Annual Public Aggregated Performance Report.
The denominator for the Referral Rate measure is the number of the potential donor population in the OPO’s DSA in the calendar year. The potential donor population includes patients who had no contraindications to donation, as noted in the denominator exclusions in Section 1.15b, are aged 0 to 80 years old who died within a hospital, and had one of the following ICD-10-CM codes listed as the primary cause of death:
- I20–I25 (ischemic heart disease), or
- I60–I69 (cerebrovascular disease), or
- V01–Y89 (external causes of death): blunt trauma, gunshot wounds, drug overdose, suicide, drowning, and asphyxiation.
For MCOD data, a death is attributed to the calendar year based on the time of death (time between 12:00 a.m. on January 1 of a calendar year and 11:59 p.m. on December 31 of that same year), as recorded on the death certificate.
Exclusions
The denominator for the Referral Rate measure excludes patient deaths over the age of 80 years old, with no discernible cause of death, and who did not die in a hospital. The denominator further excludes patient deaths with any of the following ICD-10-CM codes listed among the multiple causes of death:
- Bacterial:
- A15-A19, B90 (tuberculosis)
- K46.1, K45.1 (gangrenous bowel)
- K63.1 (perforated bowel)
- A40-A41 (intra-abdominal sepsis)
- Viral:
- B20 (HIV infection by serologic or molecular detection)
- A82 (rabies)
- A83-86, B33.3, B97.3 (retroviral infections including viral encephalitis)
- B27 (acute Epstein-Barr virus (mononucleosis))
- A92.3 (West Nile virus infection)
- A98.4 (Ebola virus)
- Fungal:
- B45 (active infection with cryptococcus)
- Parasites:
- B55 (leishmania)
- B78.7 or B78.9 (strongyloides – widespread infection)
- B50-B54 (malaria (plasmodium sp.))
- Prion:
- A81.0 (Creutzfeldt-Jakob disease)
- D60-D61 (aplastic anemia)
- D70 (agranulocytosis)
- C00-C97 (current malignant neoplasms, except non-melanoma skin cancers such as basal cell and squamous cell cancer, and primary CNS tumors without evident metastatic disease)
- Z85.820 (history of melanoma)
- Hematologic malignancies:
- C90.1, C91-C95 (leukemia)
- C81 (Hodgkin’s disease)
- C82-C88 (lymphoma)
- C90.0 (multiple myeloma)
Please see Section 1.15b Denominator Exclusions for details on denominator exclusions.
Measure Calculation
To calculate the numerator for the Referral Rate measure, begin with the set of referrals for an OPO in a calendar year and filter the data to include only referrals where the patient was ventilated and aged 0 to 80 years old. Count the number of unique referrals from this subset; this is the number of referrals for an OPO in the calendar year.
To calculate the denominator for the Referral Rate measure, we use MCOD data from the National Center for Health Statistics (NCHS) and NVSS for the calendar year of interest. The NVSS MCOD data are compiled from data provided by the 57 vital statistics jurisdictions through the Vital Statistics Cooperative Program. The death information is filtered based on potential donor criteria (see Sections 1.15a and 1.15b for full descriptions of potential donor requirements and exclusions). Each death is then assigned to their respective OPO based on the geographic location where the potential organ donor died. Alongside this, potential donors are apportioned to OPOs in counties with a waiver hospital based on the percentages calculated by CMS in their OPO Annual Public Aggregated Performance Report. The total number of potential donors per OPO is summarized; this is the total number of potential donors in an OPO in a calendar year.
To calculate the measure, divide the numerator (the number of referrals for an OPO in the calendar year) by the denominator (the number of potential donors in an OPO’s DSA for the calendar year) to determine the Referral Rate. This value is multiplied by 100, as the rate is expressed as X per 100 deaths. In addition to calculating the overall measure score, we stratified by demographic information for gender, race, and age.
Please refer to Exhibit 2: Measure Score Calculation Diagram in Attachment B for additional details.
We stratified this measure by race to better understand whether different populations are served disproportionately relative to the proportions of potential donors in the DSA. Due to the nature of the data shared by OPOs, we compare “Non-Hispanic White” and “Non-White” populations. People of Hispanic ethnicity are included in the “Non-White” category because some OPOs coded “Hispanic” as a mutually exclusive “race” category.
We stratified this measure by gender to evaluate whether the referrals received by the OPO reflect the gender proportions of deaths in the population in the OPO’s DSA.
Stratification by age permits evaluation of the population breakdown of the referrals received by the OPO as compared to the proportions of potential donors in the OPO’s DSA.
Additional stratification information is covered in Section 5.4.
There is no minimum sample size.
Supplemental Attachment
Point of Contact
Not applicable.
Steve Miller
McLean, VA
United States
Jennifer Paraboschi
Econometrica, Inc.
Bethesda, MD
United States
Importance
Evidence
To validate the importance of the Referral Rate measure for organ donation and to ensure accurate and comprehensive information when developing the measure, we performed an environmental scan of literature about the organ donation and transplant ecosystem (Rahman et al., 2025). We reviewed relevant literature for any measures or data sources that had already been explored and had potential as candidate measures. Based on this review, no appropriate measures were identified, and the team continued exploring alternative evidence for measures and amplified importance.
A thorough review of existing measures in the CMS Measures Inventory Tool (CMIT) also indicated that there were no measures comparable to the one proposed for endorsement (CMIT, n.d.). Therefore, we continued identifying potential measures using the CMS Blueprint Measure Lifecycle as a validated measure development framework.
The CMS Blueprint Measure Lifecyle was used to guide our work due to its rigorous and established approach to measure development and validation (CMS, n.d.). Econometrica operationalized the Blueprint by systematically integrating the conceptualization, specification, testing, implementation, measure use, evaluation, and maintenance phases into the project plan.
To better understand OPO operations, identify considerations for measure development, and reinforce measure importance, we conducted 7 site visits to U.S. OPOs, including organizations with Donor Care Units, totaling 45 individual interviews with OPO leadership, directors, managers, and other essential OPO frontline staff. Econometrica conducted a qualitative analysis of all interviews, which informed the development of the ecosystem map and logic model. We also identified six key aspects of organ procurement that can be measured by OPOs, one of which is referral management. A direct quote from the OPO Site Visit Report emphasizes the importance and need for the proposed referral measure: “The referral process was noted as an area where workload and efforts can go unrecognized if the donation does not proceed and should be measured. Timely referrals from donor hospitals based on correct clinical triggers was identified as an important metric…” (Rahman et al., 2026a).
We convened four meetings with a Technical Expert Panel (TEP) (Rahman et al., 2026b) and assembled an OPO stakeholder group (Rahman et al., 2026c) to gather targeted, informed feedback over five sessions (June 2025 to February 2026). The purpose of the TEP was to provide expert guidance on project strategy, measure development, and recommendations for new measures. The OPO stakeholder group served to engage OPOs in informing and testing measures and supporting the development of a shared logic model. In Fall 2025, our team solicited feedback from OPO stakeholders on a list of structural, process, and outcome measure candidates. This activity narrowed the list of measure candidates, with referral rate receiving a high percentage of agreement for advancement to the testing phase (Rahman et al., 2026c). During OPO Stakeholder Meeting 3, Econometrica continued in-depth discussions with stakeholders, further solidifying the final measures selected for the testing phase, including Referral Rate (Rahman et al., 2026c).
We also conducted a qualitative study to explore the perspectives of donor families, transplant recipients, and OPO stakeholders to better understand the emotional, practical, and systemic aspects of organ donation and transplantation (Arellano et al., 2025). Although we did not directly align findings with measure implications, the study did reinforce the importance of developing appropriate measures for overall improvements to the organ procurement and transplant system.
Evidence from the literature, TEP and OPO stakeholder group feedback, and public comments indicated the importance of ensuring accurate and timely referrals of donors to identify donor potential (Rahman et al., 2025; Rahman et al., 2026b; Rahman et al., 2026c; O’Connor & Lind, 2025). Organ donation has many inputs and influences, but the initial case for an OPO begins when a referral is received from a hospital regarding a potential organ donor candidate. A key responsibility for OPOs is to track, assess, and manage referrals. OPOs assess the medical suitability of potential donors and utilize Referral Rates to benchmark performance and identify gaps to tailor outreach and education for underperforming hospitals (Rahman et al., 2026a).
Additionally, a consensus study report from the National Academies of Sciences, Engineering, and Medicine (NASEM, 2022) concluded that performance measures for OPOs need to be standardized and aligned in efforts to maximize donor referrals, as there are gaps in standardized and publicly reported measurements related to patient referrals.
Cooperation from donor hospitals is the primary factor affecting the supply of transplantable organs. This has been previously identified in the literature (Prottas, 1988) and remains a key factor. NASEM (2022) noted that, over the past 30 years, evolving state and federal statutes and regulations have addressed the fundamental relationship between donor hospitals and OPOs, consistently identifying the timely referral of all individuals whose death is imminent or who died in the hospital as a key requirement for increasing organ donation. The proposed Referral Rate measure is intended to help improve compliance with hospital regulations related to organ donation and to promote standardized practices for the timely referral of donors and the timely pronouncement of death (NASEM, 2022).
The short-term outputs from the process measure are expected to include increased access to real-time information on donor status, enabling rapid follow-up by OPOs. Prompt follow-up allows for increased and efficient collaboration between hospitals and OPOs, which can lead to improved medical management of potential organ candidates to maximize organ donation once it is determined that donation may be possible. Ensuring an efficient referral process helps minimize variances and process issues associated with donation and reduces missed ventilated referrals.
The overall outcome associated with this measure includes a potential increase in viable organs being available for transplant and offered to transplant centers. Additionally, the outcome of a more efficient referral process will be a more cost-effective system by reducing resources directed toward inappropriate referrals.
References:
Arellano, O., Rahman, M., O’Connor, J., & Rajakannan, T. (2025). Perspectives and experiences in organ donation and transplantation: A qualitative study [Internal document]. Econometrica, Inc., Bethesda, MD.
Centers for Medicare and Medicaid Services. (n.d.). Centers for Medicare and Medicaid Services Measures Inventory Tool (CMIT). https://cmit.cms.gov/cmit#1/.
Centers for Medicare and Medicaid Services (CMS) Measures Management System. (n.d.) Blueprint Measure Lifecycle. https://mmshub.cms.gov/blueprint-measure-lifecycle-overview.
National Academies of Sciences, Engineering, and Medicine. (2022). Realizing the promise of equity in the organ transplantation system. Washington, DC: The National Academies Press. https://doi.org/10.17226/26364.
O’Connor, J., & Lind, C. (2025, August 22). Public comment report [Internal document]. Econometrica, Inc., Bethesda, MD.
Prottas, J. (1988). Shifting responsibilities in organ procurement: A plan for routine referral. JAMA, 260(6), 832–833.
Rahman, M., Arellano, O., Lind, C., Newton, L., O’Connor, J., Paraboschi, J., & Rizvi, S. (2025, June 20). OPO measurement literature review report [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., Lind, C., Newton, L., O’Connor, J., & Paraboschi, J. (2026a, April 7). OPO site visit final report [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., & O’Connor, J. (2026b). Organ Procurement Organization (OPO) performance measurement technical expert panel (TEP) meetings 1–4 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., & O’Connor, J. (2026c). Organ Procurement Organization (OPO) stakeholder group meetings 1–5 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
Measure Impact
The Referral Rate measure provides meaningful information to all stakeholders about the OPO’s performance in receiving referrals from hospitals. Measuring and assessing OPO Referral Rates provides information for OPOs to identify referral process gaps, informing quality improvement needs such as process improvement, hospital referral approaches, education, and support (Rahman et al., 2026c).
As depicted in the logic model, it is anticipated that implementing this measure will lead to opportunities for improvement, including identifying information technology enhancements. This can involve greater implementation of electronic and automated referrals in the hospital’s Electronic Medical Record (EMR) system, which OPO stakeholders have stated is helpful in reducing the time nurses spend answering clinical questions about donor suitability, thereby keeping them away from the bedside. This efficiency would improve patient care quality and reduce the related costs of care delivery by promoting system efficiencies. Additionally, NASEM (2022) noted that efficiencies and innovation in the organ donation system include modernizing information technology infrastructure and data collection and highlighted the implementation of automated organ referrals. NASEM (2022) also recommended embedding continuous quality improvement efforts into the organ donation system, including promoting the development, systematic sharing, adaptation, and use of best practices in areas such as rapid referral and early response by donor hospitals and OPOs.
References:
National Academies of Sciences, Engineering, and Medicine. (2022). Realizing the promise of equity in the organ transplantation system. Washington, DC: The National Academies Press. https://doi.org/10.17226/26364.
Rahman, M., Arellano, O., & O’Connor, J. (2026c). Organ Procurement Organization (OPO) stakeholder group meetings 1–5 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
Currently, there is no standardized metric for measuring OPO Referral Rates, creating significant challenges in performance assessment and accountability. The NASEM consensus study report (2022) called for the creation of standardized performance measures based on a consensus-driven process with limited reporting burden on health professionals or patients. OPO stakeholders have indicated that the current CMS measures, specifically denominators for measures, do not capture donor potential. The CMS measures, although valuable, have limitations and do not provide the specificity and nuance required by OPOs to address the complexity of the donor referral process (Rahman et al., 2026c). The proposed Referral Rate measure, developed through the validated and rigorous CMS Blueprint Framework, offers a solution for OPOs to accurately track performance within referrals.
Furthermore, repeated concerns regarding the existing measures were reported during the 2020 OPO rule public comment period, site visit interviews, and meetings with OPO stakeholders (CMS Final Rule, 2020; Rahman et al., 2026a; Rahman et al., 2026c). For example, one such concern is that the current measures do not fall under the OPO scope of control. This was mentioned repeatedly by stakeholders in the OPO Site Visit Report: “Several OPOs expressed concern about performance measures tying directly to activities within the control of the OPO itself” (Rahman et al., 2026a). Additionally, during TEP Meeting 1, the TEP noted “agreement that there are many systematic problems in the (CMS) metrics, such as clear statistical fallacies” (Rahman et al., 2026b).
References:
Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations. Final Rule. Published in the Federal Register on December 2, 2020, as 85 Fed. Reg. 77898. Federal Register: Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations.
National Academies of Sciences, Engineering, and Medicine. (2022). Realizing the promise of equity in the organ transplantation system. Washington, DC: The National Academies Press. https://doi.org/10.17226/26364.
Rahman, M., Arellano, O., Lind, C., Newton, L., O’Connor, J., & Paraboschi, J. (2026a, April 7). OPO site visit final report [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., & O’Connor, J. (2026b). Organ Procurement Organization (OPO) performance measurement technical expert panel (TEP) meetings 1–4 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., & O’Connor, J. (2026c). Organ Procurement Organization (OPO) stakeholder group meetings 1–5 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
The Referral Rate measure is meaningful to the target population of patients and families of organ donation by increasing the accountability of OPOs to improve timely and efficient care, beginning with the referral process. Support of this measure was strong throughout the conceptualization public comment period, with OPOs recommending process measures in nearly every comment (O’Connor & Lind, 2025). These process measures cover various areas within the OPO’s control while facilitating the donor management and allocation process. Referral/Response measures is an area that was most recommended and included the following referral attributes: referral verification from hospitals; Referral Rate of eligible donors within the established timeframe; referral volume and timeliness; and referral response practices that ensure that referrals remain viable until the chance to meet with families presents. This information provided further validation that the proposed Referral Rate measure is meaningful, producing information that is valuable in making care decisions.
During our site visits, OPOs provided information about the extensive steps and existing processes in place to ensure timely and effective referrals (Rahman et al., 2026a). They identified that all hospitals in their DSAs have consistent policies on deaths and imminent deaths tracked by the hospitals. Additionally, hospitals have specific clinical triggers that prompt the notification of the OPO of the potential for organ donation. OPOs perform weekly, monthly, quarterly, and yearly audits and reviews of hospital deaths to ensure that all referrals were received, and they assess timeliness of referrals. OPOs also often create benchmarks and goals for timely Referral Rates. These criteria and tracking help the OPO ensure referral compliance and hospital participation.
OPOs reported that tracking Referral Rates through a formal process measure will allow OPOs to benchmark performance, hold hospitals more accountable, support hospitals that may be underperforming, and identify gaps to tailor education, outreach, and training. This measure will reinforce OPO operational best practices for receipt and management of referrals, including developing communication protocols, tracking timely referrals, reviewing missed referrals, reviewing medical rule-out cases, assessing the donor population, utilizing electronic referrals, and using referral cards that registered nurses can complete. Additionally, during site visits, OPOs expressed strong agreement that donor registration and hospital engagement through referrals should be considered for key measurement areas (Rahman et al., 2026a).
References:
O’Connor, J., & Lind, C. (2025, August 22). Public Comment Report [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., Lind, C., Newton, L., O’Connor, J., & Paraboschi, J. (2026a, April 7). OPO site visit final report [Internal document]. Econometrica, Inc., Bethesda, MD.
Performance Gap
The measure is being submitted for initial endorsement.
CMS assesses OPO performance using two unendorsed quality measures: Donation Rate and Organ Transplantation Rate. A measure of Referral Rates provides essential information to OPOs to support quality improvement efforts directed at increasing referrals, which are the starting point of the organ procurement process.
The numerator data source is the OPO EDR, and the denominator data source is the MCOD data. The data are presented by OPO for our six test site OPOs:
- OPO 1 provided data from 1/1/2021 through 12/31/2024.
- OPO 2 provided data from 1/1/2021 through 12/31/2024
- OPO 3 provided data from 1/1/2022 through 12/31/2024.
- OPO 4 provided data from 1/1/2021 through 12/31/2024.
- OPO 5 provided data from 1/1/2021 through 12/31/2024.
- OPO 6 provided data from 1/1/2021 through 12/31/2024.
The Referral Rates per 100 for our 6 test site OPOs are presented in Exhibit 3: Referral Rates by OPO in Attachment B.
The Referral Rates per 100 for our 6 test site OPOs are presented in Exhibit 3: Referral Rates by OPO in Attachment B.
Care Gaps
Closing Care Gaps
This domain is optional for the Spring 2026 cycle.
Feasibility
Feasibility
All OPOs track their data electronically in EDRs and submit some donation data for regulatory purposes to the Organ Procurement & Transplantation Network (OPTN). All data elements for the measure are available electronically in structured fields. During measure testing, some standardization of data elements was necessary to allow comparisons across OPOs.
OPOs use a combination of real-time data validation to catch missing data at the point of entry and conduct QA checks on a routine basis, often during monthly reviews. OPOs indicated that missing data is infrequent, identified through routine QA checks, and completed after following up with the coordinator or staff member familiar with that stage of the OPO activity. OPOs noted that referrals that conclude with an organ donation have the most complete records, as they have moved through each step of the donation workflow. In contrast, potential donors that do not result in a donation may have less complete records if the donation was authorized and not recovered, there was no authorization, or referrals were medically ruled-out and otherwise did not proceed through the referral-approach-authorization-management-recovery pathway. This type of missing data limits the OPO’s ability to understand referral patterns, evaluate missed opportunities, and assess process performance at key decision points. While these issues do not impede measure calculations (since rates rely on MCOD for denominator data), they can limit the OPO’s internal visibility into possible operational improvements. Overall, this underscores the importance of identifying and resolving missing, incongruent, irregular, or incomplete data issues in a methodical, predictable, and timely manner.
Our testing and research indicated that there is little to no additional burden to implementing the Referral Rate measure as defined. Our test sites indicated that the data for the Referral Rate measure are already being collected by OPOs, although some manual data entry is required because some referrals are provided via telephone rather than electronically. There is also manual labor involved for hospital mortality record reviews, which OPOs are already conducting. There is no disruption to workflow, and no significant barriers for implementation of this Referral Rate measure were reported. Feedback from the TEP, stakeholders, and public comments did not indicate a concern with the burden of implementation for this measure (Rahman et al., 2026b; Rahman et al., 2026c; O’Connor & Lind, 2025).
There would be added burden if OPOs were to fully automate referrals or add infrastructure for electronic capture of referrals, as well as added burden to hospitals to add infrastructure for electronic capture of referrals; however, the benefits of automating these referrals outweigh the risks.
References:
O’Connor, J., & Lind, C. (2025, August 22). Public comment report [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., & O’Connor, J. (2026b). Organ Procurement Organization (OPO) performance measurement technical expert panel (TEP) meetings 1–4 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., & O’Connor, J. (2026c). Organ Procurement Organization (OPO) stakeholder group meetings 1–5 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
Data are collected by OPOs as part of their routine care and are captured in alignment with the Health Insurance Portability and Accountability Act (HIPAA) privacy regulations in secure systems. While OPOs observe HIPAA requirements, they are specifically categorized under an exemption to HIPAA to enable hospital-OPO-transplant center communication. There are no patient confidentiality concerns. For measure testing, the OPO data analysis did not depend on any confidential patient information beyond age (or birthdate). Therefore, unique case IDs were used for each patient record. When our team received the data, no patient names were included. All of our measures are calculated based on patient populations large enough that it would be almost impossible to identify an individual.
For testing, the data from the MCOD file did not include patient names or any other detailed information. We kept the data confidential in alignment with a data use agreement (DUA) with NCHS that included a guarantee to store it in a secure location. The DUA explained our purposes for using the data, which included a replication of CMS measures and the current development of new measures.
All of the data elements used in the measure are collected routinely by OPOs. For some data items, additional coding or details from the OPO were required before the final measure could be constructed. Thus, while initially there were some challenges in constructing some of the variables needed for the measures, with a clearer understanding of measure requirements and definitions, these variables are constructed routinely in the current data management processes of OPOs. We will also be disseminating instructions to OPOs regarding the variables for use in this measure, and a separate project is working on updates to OPO EDRs.
As noted in Section 2.2, we used our extensive collaboration with OPOs, the TEP, and site visits to provide support for a Referral Rate measure that provided meaningful information to OPOs about the success of hospital engagement efforts (Rahman et al., 2026a; Rahman et al., 2026b). Further, these collaborations ensured that the data elements were captured in EDRs and that many OPOs were already tracking this information for internal performance benchmarking and improvement efforts, further demonstrating the feasibility of this measure.
Our initial measure specifications used the assumption that OPOs determined patient ventilation status at a later point in the process. However, our data collection from test site OPOs and subsequent conversations with OPO staff revealed that ventilation status is collected at the time of referral and is reported in a valid and reliable manner by donor hospitals, as it is associated with the triggers required for hospital compliance with donation. Thus, we were able to update the measure numerator to be the number of ventilated referrals.
References:
Rahman, M., Arellano, O., Lind, C., Newton, L., O’Connor, J., & Paraboschi, J. (2026a, April 7). OPO site visit final report [Internal document]. Econometrica, Inc., Bethesda, MD.
Rahman, M., Arellano, O., & O’Connor, J. (2026b). Organ Procurement Organization (OPO) performance measurement technical expert panel (TEP) meetings 1–4 summary overview [Internal document]. Econometrica, Inc., Bethesda, MD.
Proprietary Information
Scientific Acceptability
Testing Data
OPO test sites provided data for testing, which were exported from their EDRs into Excel workbooks. As noted in Section 1.25 Data Source Details, we received testing data from six OPO test sites. Of these, four sites used LifeLogics/TrueNorth EDR and two sites used iTransplant/InVita Health EDR for donor record management. The data were quantitative, providing patient profile and demographic information for patients referred by a donor hospital to the OPO. The data included information on the referral date, ventilation status, gender, race, and age.
The MCOD file is from vital statistics data gathered by NVSS and managed by NCHS. To obtain the dataset, Econometrica entered into a DUA with NCHS. The DUA explained our purposes for using the data, which included a replication of CMS measures and the current development of new measures. The mortality data includes counts of deaths, single race categories (6 groups, 15 groups, or 31 groups), age groups (single-year age cohorts, 5-year age groups, 10-year age groups, or infant age groups), sex, ethnicity, state, county, underlying cause of death and multiple cause of death (specified in ICD-10 codes, 113 selected causes, 130 selected causes for infants, injury causes, drug/alcohol-induced causes), urbanization, year and month of death, weekday of death, place of death, and autopsy status. The MCOD data were narrowed for testing to include the ICD-10-CM cause of death codes, region information to map the deaths to the DSAs served by specific OPOs, age, and race.
All data is for a calendar year (1/1 through 12/31):
- OPO 1: 2021–2024
- OPO 2: 2021–2024
- OPO 3: 2022–2024
- OPO 4: 2021–2024
- OPO 5: 2021–2024
- OPO 6: 2021–2024
- MCOD: 2021–2024
The reliability testing and stratification used the same data that were used to construct this measure. No specific exclusions were made.
There are 56 OPOs currently meeting the Conditions for Coverage under CMS regulations as of 2023 (CMS, 2020b). CMS categorizes OPOs by the population size of their DSA. Six of the 56 OPOs volunteered to participate in measure testing by submitting anonymized patient data, data dictionaries, and definitions. They also participated in surveys and discussions about their submitted data, definitions, data capture processes, and data quality checks.
Of the six test sites that contributed data, one OPO was in the “less than 2.9 million” size, one was in the “2.9–5 million” size, one was in the “5–7.2 million” size, and three were in the “greater than 7.2 million” size (OPTN, 2025).
Our six test sites were from six states and included OPOs that were ranked as “underperforming” (three OPOs) and “passing” (three OPOs) under the current CMS performance tiers for the existing Donation Rate and Organ Transplantation Rate measures (based on 2023 CMS data) (OPTN, 2025; CMS, 2025). Five of the 6 OPOs have DSA coverage in more than one state, bringing the total count of states in this analysis to 13.
Exhibit 4 in Attachment B includes the characteristics of the six test OPOs. The six sites are reasonably representative of the 56 OPOs.
References:
Centers for Medicare & Medicaid Services. (2020b). Medicare and Medicaid programs; organ procurement organizations conditions for coverage; revisions to the outcome measure requirements for organ procurement organizations. A rule by the Centers for Medicare & Medicaid Services. https://www.federalregister.gov/d/2020-26329/p-195.
Centers for Medicare & Medicaid Services. (2025, July). OPO public performance report. Quality, Certification & Oversight Reports. https://qcor.cms.gov/OPOs.
Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR). OPTN/SRTR 2023 Annual Data Report. U.S. Department of Health and Human Services, Health Resources and Services Administration; 2025. Accessed February 2026. https://srtr.transplant.hrsa.gov/annualdatareports.
Please refer to Exhibit 5 in Attachment B for the OPO demographic information.
Reliability
Referral of a potential donor to an OPO is a critical first step in the donation process and a federal requirement in the United States, under the Omnibus Budget Reconciliation Act of 1986 (P.L. 99-509) and under 42 CFR § 482.45, CMS “Conditions of Participation.” Due to the high-cost, high-consequence nature of organ donor referrals, documentation of whether a referral took place (a binary variable found in health records) has been shown to be highly reliable at (1) the patient or encounter level, (2) the hospital to OPO level, and (3) the entity level.
Person or Encounter Level
The person or encounter-level testing method was auditing, and retrospective mortality reviews were used to audit 100% of the mortality records from the hospital and compare them to the OPOs' referral records. To ensure compliance with federal legal requirements to make referrals of potential organ donors, hospitals have routinely collected individual-level data on referrals in patient medical records. Hospitals use criteria provided by OPTN and specifically agreed to in MOUs with OPOs. The clinical criteria used to trigger referral are relatively uniform across the United States, with some variation in how rapidly (1 hour versus 2 hours) hospitals must refer patients and in whether the hospital must call or may make an electronic referral. These referral data and the associated death record reviews are then included in information that is required under 42 CFR 486.328, to be reported by OPOs to the Scientific Registry of Transplant Recipients (SRTR). Numerous studies have assessed the reliability of organ donation referral data, and several recommended more widespread use of referral data for quality improvement (Johnson et al., 2023; Traino et al., 2012).
However, EMRs are known to vary in reliability based on the complexity and type of data being captured (Chan et al., 2010). For this reason, OPOs do conduct reliability testing using multiple methods. Due to the 2020 CMS regulations that promote competition among OPOs, OPOs consider these data to be proprietary, and these reviews are not often published in the literature.
Due to the requirements in 42 CFR 486.328, all OPOs conduct retrospective mortality reviews comparing hospital death data files with the referrals received at the OPO. These reviews are often conducted on a monthly or quarterly basis, and findings are used to correct OPO referral data and provided to the hospitals to increase referral accuracy. Due to the 2020 CMS regulations that promote competition among OPOs, these data are not generally published but were shared with us as part of this project. For example, OPO X conducts these types of reviews and had a 100-percent match rate between the referrals reported and the hospitals’ records in 2024. Please refer to Exhibit 6 in Attachment B for the example of the medical record mortality review. Another OPO (OPO Y) conducts a type of these reviews by sending out a review file of referrals to hospitals, and the hospitals conduct the review against their death files. OPO Y found a 99-percent agreement rate through this process. Please refer to Exhibit 7 in Attachment B for the example of data validation of the medical record mortality review. The other four OPOs report match rates of 99-100%, but we do not have formal reports to share at this time. All OPOs are required to conduct retrospective medical record mortality reviews of their referral data by CMS.
Based on the value of referral data and the implications for OPO performance, recent studies have called for the use of the individual-level data to develop entity-level measures to assess OPO performance, as is being posed in this measure.
Accountable Entity Level
Reliability testing was conducted using the repeated split-sample methodology described by Nieser and Harris (2024), as recommended by the PQM Endorsement and Maintenance Guidebook (2025). For each of the six OPOs and for each year in the range 2021–2024, the data used to compute the numerator (count of referrals meeting all applicable inclusion and exclusion criteria, obtained from OPO data) were repeatedly resampled to create pairs of half-sample datasets, with each record randomly assigned to one half-sample or the other.
The number of repetitions was 200, which is the approximate size of the smallest OPO-year dataset used for reliability analysis. Each of the 200 half-samples of numerator data was then merged with denominator data (count of potential organ donor deaths meeting all applicable inclusion and exclusion criteria for the same OPO and year, obtained from MCOD data), and the Referral Rate measure was then computed for each half-sample. This allowed the creation of a dataset containing 200 records for each OPO and year, with each record containing the OPO and year, and the rates for each of the two half-samples. The data for each of the 200 sets of OPO-year pairs were then analyzed separately to obtain the correlation between the rates of the two randomly assigned half-samples.
The measure of correlation used was the intraclass correlation coefficient (ICC) for a one-way random effects model—ICC(1)—obtained from the covariance estimates provided by a hierarchical generalized linear model. The ICC(1) provides a measure of the total proportion of total variance of the Referral Rate that is explained by the OPO and year. (We do not currently have data from a sufficient number of OPOs to compute a statistically valid measure of correlation by OPO alone.) The average value of ICC(1) across the 200 repetitions, which is the measure of reliability, was then computed.
References:
Chan, K. S., Fowles, J. B., & Weiner, J. P. (2010, October). Review: Electronic health records and the reliability and validity of quality measures: A review of the literature. Med Care Res Rev, 67(5), 503–27. doi: 10.1177/1077558709359007. Epub 2010 Feb 11. PMID: 20150441.
Johnson, W., Kraft, K., Chotai, P., Lynch, R., Dittus, R. S., Goldberg, D., Ye, F., Doby, B., Schaubel, D. E., Shah, M. B., & Karp, S. J. (2023, April 1). Variability in organ procurement organization performance by individual hospital in the United States. JAMA Surg, 158(4), 404–409. doi: 10.1001/jamasurg.2022.7853. PMID: 36753195; PMCID: PMC9909569.
Nieser, K. J., & Harris, H. S. (2024). Comparing methods for assessing the reliability of health care quality measures. Statistics in Medicine, 43(23).
Partnership for Quality Measurement, Endorsement and Maintenance Guidebook, National Consensus Development and Strategic Planning for Health Care Quality Measurement, October 2025, p.71.
Traino, H. M., Alolod, G. P., Shafer, T., & Siminoff, L. A. (2012). Interim results of a national test of the rapid assessment of hospital procurement barriers in donation (RAPiD). American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 12(11), 3094–3103. https://doi.org/10.1111/j.1600-6143.2012.04220.x.
U.S. Congress. (1986). H.R. 5300, Omnibus Budget Reconciliation Act of 1986, 99th Cong. https://www.congress.gov/bill/99th-congress/house-bill/5300.
U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. (2026). 42 C.F.R. § 482.45: Condition of participation: Organ, tissue, and eye procurement. https://www.ecfr.gov/current/title-42/part-482/section-482.45.
U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. (2026). 42 C.F.R. § 486.328: Condition: Reporting of data. https://www.ecfr.gov/current/title-42/part-486/section-486.328.
Person or Encounter Level
Please refer to Section 5.2.2 Methods of Reliability Testing.
Accountable Entity Level
The Referral Rate reliability as estimated by the average ICC(1) value has a mean value of 0.9880, with a 95-percent confidence interval of [0.9874, 0.9886].
Person or Encounter Level
Please refer to Section 5.2.2 Methods of Reliability Testing.
Accountable Entity Level
The estimated Referral Rate reliability is 0.9880, which surpasses the minimum reliability threshold of 0.6. Therefore, this measure meets the Consensus-Based Entity requirements for reliability.
Please refer to Section 5.2.2 Methods of Reliability Testing and Section 5.2.3 Reliability Testing Results.
Please refer to Section 5.2.2 Methods of Reliability Testing and Section 5.2.3 Reliability Testing Results.
Validity
Referral of a potential donor to an OPO is a critical first step in the donation process and a federal requirement in the United States, under the Omnibus Budget Reconciliation Act of 1986 (P.L. 99-509) and under 42 CFR § 482.45, CMS “Conditions of Participation.” Due to the high-cost, high-consequence nature of organ donor referrals, documentation of whether a referral took place (a structured, binary variable found in health records) has been shown to be valid at (1) the patient or encounter level, (2) the hospital to OPO level, and (3) the entity level.
Person or Encounter Level
To ensure compliance with federal legal requirements to make referrals of potential organ donors, hospitals have routinely collected individual-level data on referrals in patient medical records. Hospitals use criteria provided by OPTN and specifically agreed to in MOUs with OPOs. The clinical criteria used to trigger referral are relatively uniform across the United States, with some variation in how rapidly hospitals must refer patients and in whether the hospital must call or may make an electronic referral. These referral data and the associated death record reviews are then included in information that is required under 42 CFR 486.328, to be reported by OPOs to the SRTR. Numerous studies have assessed the reliability of organ donation referral data, and several recommend more widespread use of referral data for quality improvement (Johnson et al., 2023; Traino et al., 2012).
However, electronic medical records are known to vary in validity based on the complexity and type of data being captured (Chan et al., 2010). For this reason, OPOs do conduct validity testing using multiple methods.
Due to the requirements in 42 CFR 486.328, all OPOs conduct retrospective mortality reviews comparing hospital death data files with the referrals received at the OPO. These reviews are often conducted on a monthly or quarterly basis, and findings are used to correct OPO referral data and provided to the hospitals to increase referral accuracy. Due to the 2020 CMS Final Rule that promotes competition among OPOs, these data are not generally published but were shared with us as part of this project. For example, OPO Y conducted this type of review and found that 1 percent of the non-referred deaths should have been referred. Please refer to Exhibit 8 in Attachment B for the example of non-referred deaths found through this review.
Because these missed opportunities represent the potential for hospitals to increase organ donation referrals to OPOs, a number of published studies have examined the variability in referrals by hospital setting type. One study conducted in a rural Appalachian acute care hospital found an unidentified referral rate of 7 percent (n = 19) and a mis-referral rate of 2 percent (n = 6) for 2002 (Carter, 2023). The researcher developed a tool called the Organ Procurement Assessment Tool (OPAT) to assess potential donors and found that the OPAT’s reliability coefficient was very high (α = .92). Other studies have examined whether referrals in certain in-hospital settings resulted in decreased validity of referral data, and another assessed whether these settings increased downstream rates of authorization (McCallum et al., 2020). Another study looked at missed referrals overall in Canada and found that the missed donation opportunities at the referral stage of the donation process was 3.6 to 4.5 per million population (McCallum et al., 2020). Additional studies have assessed the impact of tools such as electronic referral on increasing individual Referral Rates (Zavalkoff et al., 2023).
While missed referrals of potential donors, opportunities for increasing referrals, and over-referral of donors are known issues associated with validity, the literature generally considers these data to be the best and only source for this information. Based on the value of referral data and the implications for OPO performance, recent studies have called for the use of individual-level development of entity-level measures to assess OPO performance (Adam et al., 2026; Levan et al., 2022; Sauthier et al., 2023).
Accountable Entity Level
We considered both face validity, which is the assumption that the measure reflects what it says it does, and criterion validity. Criterion is the extent to which the measure relates to or predicts an outcome. Criterion validity includes both concurrent validity, which compares the measure in question to another outcome assessed at the same time such as from another data source, and predictive validity, which compares the measure to an outcome assessed at a later time.
Face validity: The data used for this measure represents the only source of information on donation referrals—all such data are ultimately provided by OPOs. These are the only data that can be used to measure this concept. For this measure, the direct counts of referrals were provided by the six participating OPOs, and they are not subjective or constructed. The denominator is what CMS adopted and represents an external, independent estimate of potential donor deaths. For these datasets, missing values were mostly not an issue. We had to remove less than a dozen observations due to missing values on age. No sensitivity analysis was conducted.
Criterion validity: To test concurrent validity, we used the MCOD for each DSA to identify the maximum number of in-hospital deaths. We quantified this by identifying an estimate of the number of hospital deaths that are ventilated (26 percent) in the healthcare utilization data produced by the Agency for Healthcare Research and Quality. We multiplied the number of deaths by 26 percent to estimate the maximum number of ventilated referrals in a DSA (an upper limit). We compared this to the number of referrals reported to us by our test OPOs to confirm that the counts were within a reasonable range (see Table 1). This added confidence that the OPO is capturing the expected population in their DSA in their referrals.
Table 1. Criterion Validity
| OPO 1 | OPO 2 | OPO 3 | OPO 4 | OPO 5 | OPO 6 |
|---|---|---|---|---|---|---|
| MCOD Deaths | 11,604 | 15,800.18 | 3,314 | 9,329 | 6,341 | 4,793.58 |
| Max Vent Referrals | 3,017.04 | 4,108.05 | 861.64 | 2,425.54 | 1,648.66 | 1,246.33 |
| Reported Referrals by OPO | 18,734 | 19,199 | 7,131 | 12,887 | 13,511 | 8,634 |
| Difference (Count) | -15,717 | -15,091 | -6,269.36 | -10,461.5 | -11,862.3 | -7,387.67 |
| Difference % | 145% | 129% | 157% | 137% | 156% | 150% |
Predictive Validity: We understand the gold standard to demonstrate validity is to determine the degree to which the performance on the measure predicts an outcome. For this measure, we chose approach rate as the outcome. We used simple regression to test the hypothesis that referral rate predicts approach rate. While a small N is a significant limitation of this analysis, we conducted it to ensure that all avenues for analysis were pursued.
Table 2. Referral Rate v. Approach Rate, R-Squared Value = 0.5234
OPO 1 | OPO 2 | OPO 3 | OPO 4 | OPO 5 | OPO 6 | |
|---|---|---|---|---|---|---|
| Referral Rate | 161 | 122 | 215 | 138 | 213 | 180 |
| Approach Rate | 16 | 36 | 13 | 19 | 18 | 18 |
References:
Adam, H., Pollard, T., Suriyakumar, V., Moody, B., Adams, J. N., Erickson, J., Segal, G., Wadsworth, M., Wilson, A., & Ghassemi, M. (2026, January 13). Organ retrieval and collection of health information for donation: The ORCHID dataset. Sci Data, 13(1), 120. doi: 10.1038/s41597-025-06435-1. PMID: 41530188; PMCID: PMC12855849.
Agency for Healthcare Research and Quality. HCUP Summary Trend Tables. All Inpatient Encounter Types: Monthly Trends in the In-Hospital Mortality Rate (Table 2d). Healthcare Cost and Utilization Project. ONLINE. March 2025.
Carter, C. F. (2003). A rural hospital’s organ donation referral pattern: A pilot study [Dissertation]. Huntington (WV): Marshall University. Available from https://mds.marshall.edu/cgi/viewcontent.cgi?article=1526&context=etd.
Chan, K. S., Fowles, J. B., & Weiner, J. P. (2010, October). Review: Electronic health records and the reliability and validity of quality measures: A review of the literature. Med Care Res Rev, 67(5), 503–27. doi: 10.1177/1077558709359007. Epub 2010 Feb 11. PMID: 20150441.
Johnson, W., Kraft, K., Chotai, P., Lynch, R., Dittus, R. S., Goldberg, D., Ye, F., Doby, B., Schaubel, D. E., Shah, M. B., & Karp, S. J. (2023, April 1). Variability in organ procurement organization performance by individual hospital in the United States. JAMA Surg, 158(4), 404–409. doi: 10.1001/jamasurg.2022.7853. PMID: 36753195; PMCID: PMC9909569.
Levan, M. L., Trahan, C., Klitenic, S. B., Hewlett, J., Strout, T., Levan, M. A., Vanterpool, K. B., Segev, D. L., Adams, B. L., Massie, A. B., & Niles, P. (2022). Short report: Evaluating the effects of automated donor referral technology on deceased donor referrals. Transplantation direct, 8(8), e1330. https://doi.org/10.1097/TXD.0000000000001330.
Luskin, R., & Nathan, H. (2015). Eligible death statistic: Not a true measure of OPO performance nor the potential to increase transplantation. American Journal of Transplantation, 15, 2019–2020.
McCallum, J., Yip, R., Dhanani, S., & Stiell, I. (2020, September). Solid organ donation from the emergency department - missed donor opportunities. CJEM, 22(5), 701–707. doi: 10.1017/cem.2019.482. PMID: 32122429.
Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations. Final Rule. Published in the Federal Register on December 2, 2020, as 85 Fed. Reg. 77898. Federal Register: Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations
Sauthier, N., Bouchakri, R., Carrier, F. M., Sauthier, M., Mullie, L. A., Cardinal, H., Fortin, M. C., Lahrichi, N., & Chassé, M. (2023, May 25). Automated screening of potential organ donors using a temporal machine learning model. Sci Rep, 13(1), 8459. doi: 10.1038/s41598-023-35270-w. PMID: 37231073; PMCID: PMC10212939.
Traino, H. M., Alolod, G. P., Shafer, T., & Siminoff, L. A. (2012). Interim results of a national test of the rapid assessment of hospital procurement barriers in donation (RAPiD). American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 12(11), 3094–3103. https://doi.org/10.1111/j.1600-6143.2012.04220.x.
U.S. Congress. (1986). H.R. 5300, Omnibus Budget Reconciliation Act of 1986, 99th Cong. https://www.congress.gov/bill/99th-congress/house-bill/5300.
U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. (2026). 42 C.F.R. § 482.45: Condition of participation: Organ, tissue, and eye procurement. https://www.ecfr.gov/current/title-42/part-482/section-482.45.
U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. (2026). 42 C.F.R. § 486.328: Condition: Reporting of data. https://www.ecfr.gov/current/title-42/part-486/section-486.328.
Zavalkoff, S., O’Donnell, S., Lalani, J., Karam, I. F., James, L., & Shemie, S. D. (2023, May). Preventable harm in the Canadian organ donation and transplantation system: A descriptive study of missed organ donor identification and referral. Can J Anaesth, 70(5), 886–892. doi: 10.1007/s12630-023-02399-1. https://link.springer.com/article/10.1007/s12630-023-02399-1.
Please refer to Section 5.3.3 Methods of Validity Testing.
Please refer to Section 5.3.3 Methods of Validity Testing.
Risk Adjustment
Because this is a process measure, risk adjustment may obscure critical information. There is some debate in the literature about donation regarding the appropriateness of risk adjustment, but we followed the Office of the Assistant Secretary for Planning and Evaluation’s recommendation not to risk-adjust process measures. We calculated stratified rates to understand how the OPOs differed across groups of interest and where there are some historical patterns of different donation rates.
We hypothesized that some entities may have varying numbers of referrals, proportionate to the number of people of races/ethnicities other than white (Non-White) in their donor pool. Stratifying by race allows us to observe potentially differential rates of referral. Similarly, we hypothesized that there will be proportionally more referrals for males due to their overall higher death rates in the under-80 age group we are examining.
We calculated stratified rates to understand how OPOs differed across groups of interest and where there are some historical patterns of different donation rates. We stratified by age, race, and gender. We considered that different age concentrations for the different OPO DSAs could affect the rates. The goal was to test if and how age, race, and gender composition differed and how they could affect the measure outcomes. Specifically, areas with older ages may have higher death rates, but that may not translate directly to higher donation rates. Stratifying by age allows us to observe if Referral Rates differ by age. One perceived issue for OPOs is obtaining full participation in the donation process for all races while also avoiding over-referral of select populations. We have stratified the rates by race to better understand if there are racial differences in donation rates and if minorities have lower referral rates. For gender, men generally have higher death rates at younger ages. Observing the differences by gender will allow us to see if there are noticeable differences in referrals by gender and understand if gender composition affects the measure.
Reference:
Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. (2020). Second report to Congress on social risk factors and performance in Medicare’s Value-Based Purchasing Program. https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/195191/Second-IMPACT-SES-Report-to-Congress.pdf.
Please refer to Exhibit 9 in Attachment B.
Age: The distribution pattern of age is the same for both datasets. There are proportionately more observations in the 25–69 age range.
Race: Despite the necessity to collapse the Non-White category, the distribution across race categories is within 5 percentage points for each group. This suggests that the OPO-reported numbers are aligned with the underlying larger distribution in the MCOD data.
Gender: The gender categories are closely aligned across the two datasets. There is less than four percentage points difference at most. This suggests that the distribution across referrals reflects the underlying distribution in the MCOD data for potential donors.
We selected the stratification variables based on what OPOs, our TEP, and the literature indicated would impact the organ donation process. We did not conduct additional statistical testing of the stratification factors.
In this section, we present Referral Rates stratified by age, race, and gender. Please refer to Exhibits 10–15 in Attachment B for the interpretation of our results.
Use & Usability
Use
The Referral Rate measure is the rate per 100 deaths of ventilated hospital referrals to the Organ Procurement Organization (OPO) of the potential donor population in the OPO’s donation service area (DSA) within a calendar year. The referral rate provides OPOs with data that will enable them to improve their referral process. While all OPOs count their referrals, they do not all do so in a standardized manner. Improving the referral process and standardizing how referrals are counted will help achieve the ultimate goal of increasing the number of viable organs available for transplant that are offered to transplant centers.
The OPO is the setting for which this measure is specified and tested, where a hospital’s referral to an OPO of a potential organ donor is the starting point of the procurement activity. A key responsibility for OPOs is to track, assess, and manage referrals. OPOs assess the medical suitability of potential donors and utilize Referral Rates to benchmark performance and identify gaps to tailor outreach and education for underperforming hospitals (Rahman et al., 2026a). The Referral Rate measure also aims to help improve compliance with hospital regulations related to organ donation and to promote standardized practices for the timely referral of donors and the timely pronouncement of death (NASEM, 2022). As such, this proposed measure is intended to be used by OPOs in the following accountability applications: internal quality assurance and performance improvement (QAPI) activities; quality improvement initiatives with external benchmarking, such as between OPOs to facilitate best practices; public reporting; and regulatory and accreditation programs.
Because the Referral Rate is a process measure, risk adjustment may obscure critical information. We followed the Office of the Assistant Secretary for Planning and Evaluation’s recommendation not to risk-adjust process measures (ASPE, 2020). We calculated stratified rates by age, race, and gender to understand how OPOs differed across groups of interest and where there are some historical patterns of different donation rates.
In discussions with OPOs, they reported that, if appropriately used, this measure would help establish best practices. These may include innovation, continuous improvement initiatives, tailored education and training, improved efficiency, greater transparency, and stronger collaboration between OPOs and donor hospitals. Furthermore, optimization of referral rates can ultimately lead to more organs being available for transplantation, thereby reducing the number of deaths on the organ transplant waiting list.
References:
National Academies of Sciences, Engineering, and Medicine. (2022). Realizing the promise of equity in the organ transplantation system. Washington, DC: The National Academies Press. https://doi.org/10.17226/26364.
Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. (2020). Second report to Congress on social risk factors and performance in Medicare’s Value-Based Purchasing Program. https://aspe.hhs.gov/sites/default/files/migrated_legacy_files/195191/Second-IMPACT-SES-Report-to-Congress.pdf.
Rahman, M., Arellano, O., Lind, C., Newton, L., O’Connor, J., & Paraboschi, J. (2026a, April 7). OPO site visit final report [Internal document]. Econometrica, Inc., Bethesda, MD.
Usability
Improvement in performance with the Referral Rate measure would mean fewer missed referrals, more timely referrals, and increased hospital compliance with the clinical triggers for donor referral set by the OPO.
OPOs can improve referral rates through Plan-Do-Study-Act cycles and tests of change. Examples of tests of change that OPOs could undertake include the following:
- Engaging in collaboration-building activities, such as more frequent visits with donor hospitals to ensure awareness and accessibility of the OPO staff.
- Collaborating with donor hospitals on training for frontline staff on referral protocols.
- Holding listening sessions with acute care and ICU staff regarding their barriers to referral or reasons for over-referral and then making changes to protocols accordingly.
- Providing job aids for frontline staff on referrals, such as pocket cards or instructional guides in nursing stations.
- Engaging with hospital leadership to ensure that donation and referral are a priority for the hospital.
- Enabling electronic referrals.
This measure has limited to no potential unintended consequences, other than potential misuse or misinterpretation of the meaning of the measure data by regulators. OPOs already make hospitals aware of their referral data and prefer that hospitals over-refer to avoid missing a potential donor. While this measure could reduce over-referral by increasing hospital awareness that over-referral is occurring, it should help OPOs and donor hospitals optimize their referral information.
Comments
Staff Preliminary Assessment
CBE #5601 Staff Assessment
Importance
Strengths:
- A clear logic model for the organ donation process is provided, depicting the relationships between inputs (e.g., demand for organs, access to medical facilities), donation activities (e.g., receipt and management of referrals), and desired outcomes (e.g., more organs transplanted). This model demonstrates how the measure's implementation will lead to the anticipated outputs.
- If implemented, the developer argued the measure’s anticipated impact on important outcomes, such as timely potential donor referrals, would be positive because the measure would provide Organ Procurement Organizations (OPOs) with a standardized means to assess their success in collaborating with hospitals to identify potential donors. This assertion is based on a National Academies of Sciences, Engineering, and Medicine (NASEM) study, the peer reviewed literature, and guidance provided by the Technical Expert Panel (TEP).
- The measure is supported by a comprehensive evidence review, including a NASEM study, a scientific literature review, seven site visits conducted with OPOs, and consultation with the TEP. This work demonstrates a clear net benefit of creating measures to assess the processes that precede organ donation, including Referral Rates. Hospital referrals represent a critical step in the process of organ donations. The measure developer argues that implementing this measure will lead to an increase in OPO approaches to donors or next of kin, which could in turn increase in the number of organs available for transplant.
- The developer described a sufficient search process. They did not identify any similar measures that address elements of the organ transplant process that are within the control of OPOs. Instead, existing measures focus on Donation Rate and Transplantation Rate, which are affected by many factors outside an OPO’s control.
- Description of patient input supports the conclusion that Referral Rate is meaningful with at least moderate certainty. Patient input was obtained through 7 OPO site visits totaling 45 interviews with OPO employees and a qualitative study conducted with 16 participants including donor families, transplant recipients, and OPO stakeholders.
Limitations:
- While data demonstrating a performance gap is optional for new measure submissions, the committee may consider seeking clarification on interpreting the performance gap data submitted. Exhibit 3 in the appendix shows referral rates of over 100% across OPOs.
Rationale:
- This new measure meets all criteria for 'Met' for importance due to the significant problem it addresses, its robust evidence base, a plausible performance gap, justifiable advantages over existing measures, and a well-articulated logic model, making it essential for addressing Referral Rate among OPOs.
- There is at least moderate confidence that the business case is adequate, i.e., that implementing a standardized measure of Referral Rate will improve organ donation process monitoring, ultimately leading to more viable organs becoming available to organ transplant centers.
Closing Care Gaps
The developer did not address this optional domain.
Feasibility Assessment
Strengths:
- All required data elements are routinely collected by OPOs and all variables are constructed routinely in OPO’s current data management processes.
- The developer described that while there were initially challenges with constructing some variables needed for the measure, those challenges were resolved by creating clearer definitions. For example, the measure specification was revised to account for findings that ventilation status is provided by referring hospitals at the time of referral rather than later in the donation process.
- The developer described the costs and burden associated with data collection and data entry, validation, and analysis. They indicated there is little to no additional burden to implement the measures as defined.
- Test sites indicate the data are already being collected and tracked by OPOs. There is some burden associated with manual data collection due to telephone referrals. There is also manual labor involved in records reviews. However, OPOs are already collecting these data and conducting these reviews. Implementing the measure will not result in any additional burden for OPOs.
- The measure is calculated using unique case IDs for each patient record. The measure developer asserted that because the measure is calculated based on a large population, it would be almost impossible to identify an individual.
- There are no fees, licensing, or other requirements to use any aspect of the measure (e.g., value/code set, risk model, programming code, algorithm).
Limitations:
- Test sites utilized two different Electronic Donor Resources (EDRs). The application could be strengthened with discussion about the feasibility of calculating the measure in additional EDRs.
Rationale:
- This new measure meets all criteria for 'Met' for feasibility due to its well-documented feasibility assessment, clear and implementable data collection strategy, clear description of adjustments made to specifications, and transparent handling of patient confidentiality, burden, licensing, and fees. These factors collectively ensure that the measure can be implemented effectively and sustainably in a real-world health care setting.
Scientific Acceptability
Strengths:
- Data used for reliability testing were sourced from six OPOs which offered to provide data for reliability testing for each year in the period 2021 to 2024. One of the OPOs provided data for years 2022 to 2024.
- The developer performed the required reliability testing for this new measure by presenting existing evidence from respective medical record mortality reviews which are required by CMS for referral data and are conducted monthly or quarterly. Agreement rates between the six OPOs referral records and hospital mortality records ranged from 99% to 100%.
Limitations:
- Note that accountable entity-level reliability testing is not required for initial endorsement, and is not considered in the rating.
Rationale:
- This new measure is rated as 'Met' for reliability because the developer provided the required evidence for this measure to demonstrate sufficient reliability at the data element-level.
Strengths:
- The developer described retrospective mortality reviews OPOs perform to help validate and correct referral data, and the developer referenced the results of data element validity testing received from one OPO, stating that 1% of non-referred deaths should have been referred (i.e., the numerator) (date of testing data not provided).
- The denominator and exclusions are defined using Multiple Cause of Death (MCOD) data, a widely used national resource for vital statistics produced by the National Center for Health Statistics (NCHS). These data are mapped to each OPO's Donor Service Area (DSA).
Limitations:
- The developer characterized the processes OPOs use to ensure the validity of referrals as sufficient, but they also acknowledged there is currently no standardized approach across OPOs. While the developer was able to share limited evidence of the validity of referral data at one OPO, testing reported by one OPO may not reflect data element validity at other OPOs.
Among the evidence the developer provided for validity of referral data was one small study in the United States using 2002 data that found a mis-referral rate of 7%, and a larger study performed in Canada that found a missed referral rate of 3.6 to 4.5 per million Canadian population, but these studies may have limited applicability to the U.S. healthcare system in 2026.
Regarding the denominator and exclusions, while MCOD data may generally be considered valid and reliable, in their submission for CBE 5604, the developer acknowledged issues with the completeness of cause of death data due to variability in reporting practices and difficult to diagnose or underreported conditions. These issues may primarily affect the accuracy of the data elements used for exclusions, and more detailed information from the literature or other sources regarding the accuracy of the coding for these conditions should be provided, if available. - Note that accountable entity level validity testing is not required for initial endorsement, and is not considered in the rating.
- The developer applied stratification to measure results based on age, gender, and race. However, it is unclear in the submission how the risk factors were selected and if the factors vary in prevalence across measured entities, warranting stratification for meaningful entity comparisons. The analytical results provided address equity and descriptive reporting, but do not demonstrate that stratification improves measure validity or fairness of comparisons across entities.
Rationale:
- This new measure is rated as ‘Not Met But Addressable’ for validity because the validity testing results partially support an inference of validity for the measure, suggesting that the measure somewhat accurately reflects performance on quality and can distinguish good from poor performance to a limited extent. There are several opportunities for the developer to provide additional information that could improve the assessment of data element validity.
- Stratification was applied to manage differences due to patient characteristics, but the developer did not demonstrate how the patient characteristics were selected or that they impact measure score comparisons across entities.
Use and Usability
Strengths:
- The measure is not currently in use, but the developer described the measure as appropriate for internal quality assurance and performance improvement (QAPI) activities, quality improvement initiatives with external benchmarking, public reporting, and regulatory and accreditation programs.
- The developer provided a summary of how accountable entities can use the measure results to improve performance. Specifically, OPOs can engage in collaboration building activities with hospitals, offer training for front line staff on referral protocols, hold listening sessions with acute care and intensive care unit staff regarding barriers to referral, provide job aids for front line staff on referrals, engage with leadership to ensure referral rates are a priority to hospitals, and enable electronic referrals.
Limitations:
- The committee may wish to discuss potential unintended consequences in that they did not consider potential consequences related to over-referral from the perspective of hospitals, health care providers, or donors/next of kin.
Rationale:
- This new measure is rated ‘Met’ for use and usability, because there is discussion of the specific attributes of an accountability program in which the measure supports quality improvement, there is a plan for use in at least one accountability application after endorsement but before the measure's first maintenence review, and performance scores yeild actionable information that can be used to improve performacen among measured entities.
Committee Independent Review
Addresses a significant…
Importance
Addresses a significant problem that has actionable methods to address a performance gap. Conducted robust research to gain insights into measure importance and meaningful with a range of stakeholders. Provided justification for establishing a new measure, and the gap it would fill.
Closing Care Gaps
Optional
Feasibility Assessment
Conducted preliminary work to understand reporting requirements and data availability. Made measure modifications to fit the needs of most OPOs for data quality and assurance. Future refinements to the data reporting systems (e.g., EDRs) would enhance data quality. As noted by the developers, there would be added burden if OPOs were to fully automate referrals or add infrastructure for electronic capture of referrals, as well as added burden to hospitals to add infrastructure for electronic capture of referrals.
Not a proprietary measure and no fees or licensing. Clear handling of patient confidentiality.
Scientific Acceptability
Reliability testing was conducted using the repeated split-sample methodology. The Referral Rate reliability as estimated by the average ICC(1) value had a mean value of 0.9880, with a 95% CI of [0.9874, 0.9886]. The estimated Referral Rate reliability is 0.9880, which surpasses the minimum reliability threshold of 0.6.
Limited evidence of validity due to small N of OPOs and variability across facilities in reporting mortality data. Also relies on one study from 2002 that may not be generalizable to the US context.
While the developers include a rationale for risk stratification over risk adjustment the inclusion of the selected characteristics are not justified. For example, would geographic variation also need to be accounted for?
Use and Usability
Not currently in use but suggests OPOs can use PDSA cycles to address performance gaps. Also discusses opportunities for benchmarking, regulatory programs and public reporting. Would recommend also including technical assistance on measure implementation and opportunities for feedback.
Summary
Addresses a significant problem that was developed with feedback from multiple stakeholder group. Presents advantages over existing measures that is feasible and usable. Additional data on validity and risk stratification will strengthen the measure
accept if unmet but addressable resolved
Importance
General information: "This measure is the rate per 100 deaths of ventilated hospital referrals to the Organ Procurement Organization (OPO) of the potential donor population in the OPO’s donation service area (DSA) within a calendar year.” Again cutoff is age 80. Importance: In addition to literature review, “A thorough review of existing measures in the CMS Measures Inventory Tool (CMIT) also indicated that there were no measures comparable to the one proposed for endorsement (CMIT, n.d.).” “The CMS Blueprint Measure Lifecyle was used to guide our work due to its rigorous and established approach to measure development and validation.” Impact “As depicted in the logic model, it is anticipated that implementing this measure will lead to opportunities for improvement, including identifying information technology enhancements.”
Closing Care Gaps
optional
Feasibility Assessment
“All OPOs track their data electronically in EDRs and submit some donation data for regulatory purposes to the Organ Procurement & Transplantation Network (OPTN). All data elements for the measure are available electronically in structured fields.”
Scientific Acceptability
“Due to the high-cost, high-consequence nature of organ donor referrals, documentation of whether a referral took place (a binary variable found in health records) has been shown to be highly reliable at (1) the patient or encounter level, (2) the hospital to OPO level, and (3) the entity level.”
“Due to the high-cost, high-consequence nature of organ donor referrals, documentation of whether a referral took place (a structured, binary variable found in health records) has been shown to be valid at (1) the patient or encounter level, (2) the hospital to OPO level, and (3) the entity level.”
Risk adjustment – “Because this is a process measure, risk adjustment may obscure critical information.“
Use and Usability
Not in use. Future use: public reporting, accreditation, quality improvement. For Usability “Improvement in performance with the Referral Rate measure would mean fewer missed referrals, more timely referrals, and increased hospital compliance with the clinical triggers for donor referral set by the OPO.”
Summary
Another important measure similar to previous measures 5603 and 5604. Network for Hope and IA Donor Network support.
Great measure with some further explanation needed
Importance
Agree with exclusions. Unclear what the actual measure numerator and denominator produce. Also, I don’t see how measuring the referral numbers will support increasing them. Reasons for referrals, or lack of them, are multifactorial and at times outside of the hospital’s control. This measure doesn’t clearly address the root cause of the problem. Only points it out.
Closing Care Gaps
Not submitted.
Feasibility Assessment
Agree with Batelle staff evaluation. I do not see how testing two very different methods of collecting data supports the feasibility.
Scientific Acceptability
Agree with Batelle's review and comments.
Use and Usability
I do not understand how this measure will incentivize referrals. Agree with Batelle's review in that potential unintended consequences as over-referral or unintended results towards the facility as it does not account for reasons outside of the control of the facility.
Summary
I am not sure how this measure will really improve referrals as it does not account for those patients whose family decline for religious or other reasons. It increases responsibility to the facility without accounting for situations the facility can control.
I support.
Importance
Closing Care Gaps
Feasibility Assessment
Scientific Acceptability
Use and Usability
Summary
I am in support of this measure.
Clearly an important measure
Importance
Clearly important
Closing Care Gaps
Optional
Feasibility Assessment
No concerns
Scientific Acceptability
No concerns
I think the developer can provide further information to aid with assessment of data validity.
Use and Usability
No concerns
(No subject)
Importance
Based upon the strong support of the OPO network in the public comments, reflects that this measure would show an important process step in the organ donation process. A useful framework highlights the step from potential donor to referred donor to authorized donor to actual donor to transplanted organs. Having a series of process measures would allow health systems and OPOs to more accurately identify where performance issues exist and then develop plans to improve.
Closing Care Gaps
Feasibility Assessment
One consideration is that addition of 4 new measures (5601, 5602, 5603, 5604) could present challenges for being able to acquire all of that information in a timely fashion if these are new measures for health systems and based on how the hospitals and OPOs are currently capturing the needed information.
Scientific Acceptability
Use and Usability
(No subject)
Importance
Closing Care Gaps
Optional not submitted
Feasibility Assessment
Data are already being collected. Source is said to be electronic health records. Would clarify that the records are the data systems of the OPOs which may reflect in part info from patient electronic health records.
Scientific Acceptability
No “failing” OPO data were analyzed. MCOD numbers were less than referral numbers. MCOD data include patients who would not be eligible for donation or referral. Covid as cause of death was not an exclusion.
Use and Usability
OPOs currently collect information and presumably already can use such information to drive improvement. Are there data to show that additional activities would result by adopting this measure? Are there data to show that referral rates can be used to distinguish high quality OPO performance from low quality?
Additional information…
Importance
Closing Care Gaps
Not addressed by developer
Feasibility Assessment
Scientific Acceptability
Agree with Battelle's comments
Use and Usability
Summary
Additional information around the scientific acceptability validity and selection for risk stratification would improve the strength of this measure.
CBE #5601: Rate of Hospital Referrals of Potential Organ Donors
Importance
This measure is important and addresses an unmet need to assess the very beginning of the process.
Closing Care Gaps
Optional
Feasibility Assessment
Measure takes advantage of existing systems for data collection.
Scientific Acceptability
Strong reliability results.
Validity testing methods are unclear.
Also, they note that there is no standardized approach across OPOs to ensure the validity of referrals.
Use and Usability
Since this is a new measure, it's not yet in use. The developer has outlined plans to do so.
Summary
This seems to be a reasonable and useful measures with some clarifications needed around validity.
(No subject)
Importance
Closing Care Gaps
optional criterion
Feasibility Assessment
Scientific Acceptability
agree with staff assessment
Use and Usability
(No subject)
Importance
This is an important and meaningful measure that may help reduce the wait time and save lives. There is an increase in dialysis centers were many patients have end stage CKD and this patient population can be positively impacted. Also, the standardized training may improve donor referrals across all sites. The measure considered patient factors, but I could not determine how respect was addressed in the process with the donor or the donor family.
Closing Care Gaps
not addressed
Feasibility Assessment
Although there are some burdens in the using EDR, it does not outweighs the increase in donor referrals.
Scientific Acceptability
I feel this is a reliable measure and current references.
Public Comments
Comment in Support of CBE ID 5601
Please see attached.
Response to Public Comment
Thank you for sharing your personal experience with organ donation. Your thoughtful comments support the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to share your perspective.
Public Comment CBE ID: 5601
Please see attached.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
NEDS Public Comment Letter CBE IDs: 5601 -5604
Please see attached
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
AOPO Supports the Referral Rate Measure
The Partnership for Quality Measurement
P.O. Box 1532
Brunswick, GA 31521
RE: CBE IDs: 5601, 5602, 5603, 5604
Dear Partnership for Quality Measurement (PQM) Team:
The Association of Organ Procurement Organizations (AOPO) appreciates the opportunity to provide comments on the following measures:
BACKGROUND
AOPO is the national trade association representing 47 of the nation’s organ procurement organizations (OPOs). OPOs are federally designated, non-profit organizations responsible for facilitating deceased organ donation in partnership with donor hospitals, donor families, transplant centers, and other stakeholders across the donation and transplantation system. OPOs serve every community in the United States and play a critical role in helping save and improve lives through organ donation and transplantation.
DISCUSSION
AOPO strongly supports endorsement of CBE IDs 5601, 5602, 5603, and 5604 because they provide a more accurate, actionable, and accountable framework for evaluating organ donation performance than the measures currently used by CMS. These measures are critical to strengthening the nation's organ donation system and ensuring that every donation opportunity is maximized.
Meaningful improvement in the organ donation system depends on performance measures that accurately assess the responsibilities of each stakeholder. Effective measurement should evaluate the activities organ procurement organizations directly control, rather than relying solely on end-stage outcomes influenced by multiple stakeholders. When metrics fail to reflect actual performance, they can obscure opportunities for improvement, misdirect accountability, and ultimately affect patients awaiting lifesaving transplants.
Current Performance Measures Do Not Fully Measure OPO Performance
The two current CMS metrics—donation and transplant rate—do not fully reflect the work performed by OPOs. In particular, the current transplant rate reflects the performance of the broader system, including transplant centers, acceptance practices, transportation and other factors beyond an OPO’s control. This makes it difficult to fairly evaluate performance or identify where improvements are truly needed. As a result, the current framework risks unintended consequences for patients and system stability.
Endorsement Is Critical to Protecting System Stability and Patient Access
Under existing CMS regulations, nearly two thirds of OPOs could face decertification or competition this year. Based on current data, OPOs serving up to 72 percent of the U.S. population will be impacted by the end of 2026. Such widespread disruption across the donation system poses significant risks to a highly coordinated and time-sensitive donation system. The focus should be on improving performance while maintaining continuity of care for patients and donor families.
Organ donation relies on seamless collaboration among hospitals, donor families, OPOs, transplant centers, and transportation partners. Instability in any part of this process can jeopardize donation opportunities and delay transplantation for patients in need. Endorsing measures that more accurately assess OPO performance is essential to ensuring accountability while preserving continuity of care and maintaining public confidence in the system.
The Proposed Measures Are Scientifically Rigorous and Broadly Supported
AOPO, in partnership with 53 OPOs and Econometrica, Inc., launched a national effort to develop better performance metrics identified as the four measures mentioned above. These measures are the result of a rigorous, multi-stakeholder development process that included independent measure development experts, technical expert panel input, stakeholder interviews, site visits, literature review, and testing aligned with CMS measure development standards. As a result, these measures are scientifically sound, objective, and well-positioned to support national quality improvement efforts.
The development process also generated extraordinary collaboration across the OPO community. Ninety eight percent of OPOs participated in the measure development process and committed to advancing a common framework for quality improvement and accountability. This level of engagement demonstrates broad stakeholder confidence in the measures and a collective commitment to improving outcomes for donor families, transplant candidates, and recipients.
The Measures Provide Actionable Insights Throughout the Donation Process
A key strength of these measures is that they evaluate the full donation pathway, including referral, family approach, authorization, and donation. Together, they provide a comprehensive picture of the activities OPOs perform every day to facilitate organ donation.
Unlike outcome measures alone, these metrics identify where barriers exist within the donation process, enabling targeted quality improvement efforts. They support stronger hospital partnerships, improved family authorization practices, and more effective identification of donation opportunities. Most importantly, they provide actionable information that can be used to improve performance at each step of the donation process.
Endorsement Will Advance Accountability, Transparency, and More Lives Saved
Endorsing these four measures would establish a performance framework that is fairer, more transparent, and more useful for driving improvement. Accurate measurement strengthens accountability by evaluating what OPOs actually do, while also creating opportunities for collaboration and continuous quality improvement across the donation system.
Ultimately, endorsement is about more than measurement. These metrics will help maximize donation opportunities, improve coordination among stakeholders, strengthen public trust, and increase the number of organs available for transplantation. Better measurement leads to better performance, and better performance means more lives saved.
CONCLUSION
AOPO appreciates the opportunity to provide comments on the proposed measures—CBE IDs 5601, 5602, 5603, and 5604—for endorsement. We strongly support their endorsement and believe they represent a significant advancement in the measurement of OPO performance.
These measures provide a scientifically rigorous, transparent, and actionable framework that better reflects the work performed by OPOs and supports continuous quality improvement across the donation system. Endorsement by PQM would help advance a more meaningful approach to performance measurement – one that strengthens accountability, promotes collaboration, supports system stability, and ultimately helps save more lives through organ donation and transplantation.
As an organization committed to advancing strategies that increase the number of lives saved through organ donation and transplantation, AOPO offers these comments in support of that mission.
Sincerely,
Allison J. Erickson
AOPO President
Chief Administrative Officer, New England Donor Services (NEDS)
On behalf of:
The Association of Organ Procurement Organizations (AOPO)
McLean, Virginia
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Comments in Support of the Measurement Proposal
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
The Federation of American…
The Federation of American Hospitals (FAH) supports the goal of these measures to increase referrals of and access to potential organ donors; however, it is crucial that safe outcomes and improved patient experience be maintained. In addition, the process of identifying and approaching potential donors and their families must be done respectfully and there is a real risk of unintended negative consequences with each of these four measures when used for accountability purposes. As a result, we believe that each measure must be well specified, demonstrated to be feasible, and produce reliable and valid results prior to endorsement. Perhaps most importantly, robust input from patients and families is needed to ensure that the process is respectful of their perspectives and decisions and that the measures are designed to facilitate these discussions.
The FAH believes that additional refinements and testing may be needed to address the following concerns:
The FAH asks that the committee carefully consider these items during their review of this measure.
Response to Public Comment
Thank you for your comments and for taking the time to share your concerns. We appreciate the support of the Federation of American Hospitals (FAH) in the goal of the measures and understand FAH, as the association that represents for-profit hospitals, may be concerned about the costs of these measures to hospitals. We first want to clarify that these are measures of Organ Procurement Organizations (OPOs), not hospitals. While some OPOs are hospital-based, the activities reflected in these measures are already statutorily required of OPOs and, therefore, should not result in any additional costs to OPOs. Where the measures will promote increased engagement with donor hospitals and transplant centers, those costs should be overcome by the benefits of participation in payment for donor care and lifesaving transplants.
Additionally, we agree that safe outcomes and improved patient experience should be maintained, and OPOs seek to identify and approach donor families in ways that are respectful. We entirely agree that robust input from patients and families is essential, which is why the 53 OPOs that worked to develop these measures engaged a Technical Expert Panel with transplant recipient and donor family representation and conducted interviews with transplant recipients and donor families. In addition, some of the OPO representatives in the process are also donor family members or parents or transplant recipients themselves.
Regarding your comment about the calendar year, we did display only the aggregated years of data in the tables in this report. We did this primarily because donation is a rare event, and when broken down further by year and Donation Service Area (DSA), race, gender, and age, we ran the risk of publishing a number that could allow for the identification of the OPOs in the pilot study or, more problematically, the actual donor patients. This would have violated the data use agreements in place with the pilot sites and could have caused significant harm to donor families. However, we did conduct the analysis suggested by year to understand the results. We included the years 2021–2024 to ensure we were able to capture years that included the COVID-19 pandemic, which substantially impacted death rates and causes of death, as well as the years during which the opioid epidemic peaked. Opioid usage is also correlated with increased deaths by causes consistent with organ donation. We looked at means, medians, modes, and ranges to ensure the measure is meaningful, including for OPOs with small DSAs.
Regarding the National Vital Statistics System (NVSS) Multiple Cause of Death (MCOD) data, these are readily available through the Centers for Disease Control and Prevention (CDC) website. The Centers for Medicare & Medicaid Services (CMS) currently uses this data in its existing OPO measures. OPOs currently obtain these data cost-effectively and efficiently through the Association of Organ Procurement Organizations (AOPO), which will provide each OPO with the data for their DSA. OPOs or others that wish to freely access the data may do so using the publicly available preliminary version on CDC's WONDER tool, although due to the need to adjust the data by hospital (and not merely county), this should be done only by knowledgeable individuals who have the latest information regarding hospital participation waivers in DSAs.
Regarding reliability, we encourage FAH to review the detailed explanation of reliability provided in the measure and for the data provided. The Partnership for Quality Measurement (PQM) provides measure developers and stewards alternatives to conducting expensive interrater reliability studies, including submissions of reports and audit documentation to demonstrate reliability.
Regarding the numerator and denominator exclusions, for the denominator, we do explain that the donor population exclusions were developed using input from the AOPO Medical Advisors regarding the conditions and associated causes of death that would rule a patient out from donation. HIV was included in the medical criteria for exclusion for the purposes of calculation of the potential donor population because HIV-positive donors are only utilized when they can be matched with an HIV-positive transplant recipient. The age cutoff of 80 was also developed with input from the AOPO Medical Advisors and was based on the data. This measure is intended to support an OPO's understanding of whether they are receiving the rate of referrals they should receive relative to potentially eligible donors who die in a hospital on a ventilator across the population as a whole in their DSA. While donation does occur in very rare situations among those over 80, it is not common, and yet persons over age 80 make up a disproportionately large population of those patients who die in a hospital on a ventilator. By removing those over the age of 80, the signal-to-noise ratio of the measure is dramatically improved.
Please see attached document…
Please see attached document.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Public Comment CBE ID: 5601 Rate of Hospital Referrals
Public comment from Versiti Blood Health, Inc. OPO attached regarding measure 5601.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
CORE Public Comment
Please see attached document.
Response to Public Comment
Thank you for your comments and for taking the time to share your concerns. We appreciate the opportunity to clarify this issue. To address your comments in order, we want to start with WONDER. As discussed in stakeholder meetings with Organ Procurement Organization (OPO) representatives, the denominator uses the Multiple Cause of Death (MCOD) file rather than WONDER, which contains preliminary files. An OPO could use WONDER and preliminary files to estimate and then reconcile. We do understand there is a time lag; however, there is no other nationally available data source to use to estimate the potential donor population. As you know, the Association of Organ Procurement Organizations (AOPO) has approached the Centers for Disease Control and Prevention (CDC) and other federal agencies about developing a new data source that would better meet OPOs needs. We look forward to working with all OPOs, CDC, the Centers for Medicare & Medicaid Services (CMS), and the Health Resources and Services Administration (HRSA) and to that data source being available in the future.
In terms of the exclusion criteria, as you also know from your participation in the OPO Stakeholder Group that developed these measures, the exclusion criteria were developed in collaboration with the AOPO Medical Advisors. The list was carefully vetted, and it reflects the best clinical practices available at this time.
Public Comment CBE ID: 5601 Rate of Hospital Referrals
Comment Attached
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Public Comment CBE ID: 5601 Rate of Hospital Referrals
Mid-South Transplant Foundation Public Comment on CBE ID: 5601 Rate of Hospital Referrals. Please see attached.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Lifeline of Ohio (OHLP) Public Comment
See attached comment
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
MORA comment on CBE ID:5601 Rate of Hospital Referrals
Please see attached our comment on this critical document.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
HonorBridge Public Comment, CBE 5601
See Attachment.
CBE ID: 5601 Comment
Public comment from Iowa Donor Network attached regarding measure 5601.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
DNAZ PQM Public Comment 7.1.26
DNAZ PQM public comment is attached.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Comments in Support of the AOPO Performance Measurement Proposal
I appreciate the opportunity to provide comments on CBE ID: 5601 Rate of Hospital Referrals of Potential Organ Donors Made to the Organ Procurement Organization (OPO) from within the OPO’s Donation Service Area in a Calendar Year (Referral Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
Per CMS regulations, hospitals are required to refer potential organ donors to their designated Organ Procurement Organization (OPO) for evaluation. In turn, OPOs are expected to partner with hospitals by providing referral education and conducting medical record reviews to verify that appropriate referrals are occurring. For many years, OPOs have consistently performed these reviews and shared findings with their hospital partners to identify and address gaps in donor identification and referral practices. Strengthening referral processes is essential, as improving referral rates can increase the number of organs available for transplantation and help reduce deaths among patients on the transplant waiting list.
Therefore, Referral Rate is a critical performance metric for OPOs. It not only reflects an essential operational process but also serves as a key indicator of effective collaboration between OPOs and hospitals.
Under current CMS regulations, OPO performance is evaluated primarily through donation and transplantation rates. While important, these measures do not fully reflect the role of organ procurement organizations within the donation ecosystem. In particular, the transplant rate is influenced by the performance of the broader system—including transplant centers, allocation, and logistics—making it an imprecise measure of OPO-specific performance.
Additionally, the current framework establishes a forced distribution model in which OPOs are comparatively ranked, placing organizations at risk of decertification based on relative performance rather than objective standards. This zero-sum approach—unlike any other Medicare program—introduces unnecessary instability into the nation’s organ donation and transplantation system and may ultimately place patients at risk.
True accountability and meaningful improvement require accurate, role-specific measurement. Oversight should reflect what OPOs directly control and influence—not just downstream outcomes. Strong, well-designed metrics enable better decision-making, clearer accountability, improved system coordination, and increased public trust.
This proposed measure directly assesses a core OPO responsibility.
The measure is grounded in science, developed using CMS-aligned methodologies, and independently validated in partnership with Econometrica, an independent third-party research organization. This rigorous, data-driven approach ensures objectivity, reliability, and practical applicability.
Endorsement and adoption of this measure will enable OPO leaders to better identify opportunities for process improvement, enhance performance, and maximize donation potential. Importantly, it will also strengthen transparency and reinforce public confidence in the donation system.
Most critically, aligning performance measurement with actual OPO responsibilities will reduce the risk of disruption caused by the current methodology and support a more stable, effective system—one that is better positioned to save lives through organ donation and transplantation.
Thank you for the opportunity to comment and for your consideration of these important measures.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Comment in Support of the AOPO Performance Measurement Proposal
I appreciate the opportunity to provide comment on CBE ID: 5601 Rate of Hospital Referrals of Potential Organ Donors Made to the Organ Procurement Organization (OPO) from within the OPO’s Donation Service Area in a Calendar Year (Referral Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
Under current CMS regulations, hospitals are required to notify their designated OPO of all potential organ donors for evaluation, and OPOs are expected to partner with hospitals to provide referral education and conduct medical record reviews to verify that appropriate referrals are occurring. For many years, OPOs have consistently performed these reviews and shared findings with their hospital partners to identify and address gaps in donor identification and referral practices. Strengthening referral processes is essential, as improving referral rates can increase the number of organs available for transplantation and help reduce deaths among patients on the transplant waiting list.
Referral Rate is a critical performance metric for OPOs. It not only reflects an essential operational process but also serves as a key indicator of effective collaboration between OPOs and hospitals.
Under current CMS regulations, OPO performance is evaluated primarily through donation and transplantation rates. These measures do not fully reflect the role of OPOs within the donation ecosystem. The transplant rate in particular is influenced by the performance of the broader system—including transplant centers, allocation processes, and logistics—making it an imprecise measure of OPO-specific performance.
The current framework establishes a forced distribution model in which OPOs are comparatively ranked, placing organizations at risk of decertification based on relative performance rather than objective standards. This zero-sum approach, which is unlike any other Medicare program, introduces unnecessary instability into the nation’s organ donation and transplantation system and may ultimately place patients at risk.
True accountability and meaningful improvement require accurate, role-specific measurement. Oversight needs to reflect what OPOs directly control and influence—not just downstream outcomes. Strong, well-designed metrics enable better decision-making, clearer accountability, improved system coordination, and increased public trust.
This proposed measure directly assesses a core OPO responsibility. The measure is grounded in science, developed using CMS-aligned methodologies, and independently validated in partnership with Econometrica. This rigorous, data-driven approach ensures objectivity, reliability, and practical applicability. Endorsement and adoption of this measure will enable OPO leaders to better identify opportunities for process improvement, enhance performance, and maximize donation potential. It will also strengthen transparency and reinforce public confidence in the donation system.
Most critically, aligning performance measurement with actual OPO responsibilities will reduce the risk of disruption caused by the current methodology and support a more stable, effective system—one that is better positioned to save lives through organ donation and transplantation.
Thank you for the opportunity to comment and for your consideration of these important measures.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Gift of Life Donor Program Comment on CBE 5601-5604
Gift of Life Donor Program Comment on CBE 5601-5604
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
The Partnership for Quality…
The Partnership for Quality Measurement
P.O. Box 1532
Brunswick, GA 31521
RE: CBE ID: 5601
Dear Partnership for Quality Measurement (PQM) Team:
I appreciate the opportunity to provide comments on CBE ID: 5601 Rate of Hospital Referrals of Potential Organ Donors Made to the Organ Procurement Organization (OPO) from within the OPO’s Donation Service Area in a Calendar Year.
Meaningful improvement in the organ donation system requires strong, accurate metrics that reflect the work and responsibilities of each stakeholder—not simply the final outcome. The current CMS donation and transplant rate measures do not fully capture the role of OPOs, and the transplant rate is influenced by the entire system, including transplant centers and logistics. This makes it difficult to fairly evaluate performance, identify where improvement is needed, and protect stability for patients and donor families. With nearly half of OPOs potentially facing decertification or competition this year—and OPOs serving up to 72 percent of the U.S. population potentially impacted by the end of 2026—the risk of widespread disruption is significant.
To address these concerns, AOPO partnered with 53 OPOs and Econometrica, Inc. to develop four measures that more accurately evaluate the work OPOs perform throughout the donation process—from referral and family approach through authorization and donation. Developed through a rigorous, multi-stakeholder process consistent with CMS standards, these measures provide greater transparency and allow organizations to identify specific opportunities for targeted improvement. Stronger, more actionable metrics will support accountability, continuity of care, and ultimately better outcomes for patients waiting for a lifesaving transplant.
At Iowa Donor Network, we use data-driven quality improvement efforts to strengthen hospital partnerships, improve family authorization practices, and maximize donation opportunities. The proposed measures—including referral rates, approach data, authorization rates, and hospital engagement—provide actionable information that supports continuous improvement throughout the donation process.
We review this data not only at an organizational level, but directly with our team members to help identify opportunities, reinforce best practices, and improve performance. Through my work on the AOPO Impact Committee, similar data is also used to identify successful practices and share them across the organ procurement community, supporting improvement beyond our own organization.
These accurate metrics will help ensure that every donation opportunity is maximized. They support better coordination across the system, so organs reach patients faster, and they strengthen transparency and public trust, which is essential for donation. Ultimately, better measurement means more transplants and more lives saved.
I appreciate the opportunity to provide comments on this proposed measure for endorsement. At Iowa Donor Network, we are committed to advancing thoughtful, data-driven strategies that strengthen the donation system and increase the number of lives saved through organ donation and transplantation. I offer these comments in support of that shared mission.
Sincerely,
Angie Capps
Director of Inspire the Gift, Iowa Donor Network
Member, AOPO Impact Committee
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Rate of Hospital Referrals of Potential Organ Donors Support
The proposed hospital referral rate for potential organ donors better aligns performance measurement with the actual responsibilities of Organ Procurement Organizations (OPOs) and provides a direct measure of an essential OPO responsibility, supporting more accurate and meaningful performance evaluation.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Public Comment on CBE ID 5601: OPO Referral Rate Measure
Per CMS regulations, hospitals are required to refer potential organ donors to their designated Organ Procurement Organization (OPO) for evaluation. In turn, OPOs are expected to partner with hospitals by providing referral education and conducting medical record reviews to verify that appropriate referrals are occurring. For many years, OPOs have consistently performed these reviews and shared findings with their hospital partners to identify and address gaps in donor identification and referral practices. Strengthening referral processes is essential, as improving referral rates can increase the number of organs available for transplantation and help reduce deaths among patients on the transplant waiting list.
Therefore, Referral Rate is a critical performance metric for OPOs. It not only reflects an essential operational process but also serves as a key indicator of effective collaboration between OPOs and hospitals.
Under current CMS regulations, OPO performance is evaluated primarily through donation and transplantation rates. While important, these measures do not fully reflect the role of organ procurement organizations within the donation ecosystem. In particular, the transplant rate is influenced by the performance of the broader system—including transplant centers, allocation, and logistics—making it an imprecise measure of OPO-specific performance.
Additionally, the current framework establishes a forced distribution model in which OPOs are comparatively ranked, placing organizations at risk of decertification based on relative performance rather than objective standards. This zero-sum approach—unlike any other Medicare program—introduces unnecessary instability into the nation’s organ donation and transplantation system and may ultimately place patients at risk.
True accountability and meaningful improvement require accurate, role-specific measurement. Oversight should reflect what OPOs directly control and influence—not just downstream outcomes. Strong, well-designed metrics enable better decision-making, clearer accountability, improved system coordination, and increased public trust.
This proposed measure directly assesses a core OPO responsibility.
The measure is grounded in science, developed using CMS-aligned methodologies, and independently validated in partnership with Econometrica, an independent third-party research organization. This rigorous, data-driven approach ensures objectivity, reliability, and practical applicability.
Endorsement and adoption of this measure will enable OPO leaders to better identify opportunities for process improvement, enhance performance, and maximize donation potential. Importantly, it will also strengthen transparency and reinforce public confidence in the donation system.
Most critically, aligning performance measurement with actual OPO responsibilities will reduce the risk of disruption caused by the current methodology and support a more stable, effective system—one that is better positioned to save lives through organ donation and transplantation.
Thank you for the opportunity to comment and for your consideration of these important measures.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Public Comment CBE ID: 5601 Rate of Hospital Referrals
Thank you for the opportunity to submit Public Comment. See attached letter.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
5601 Public Comment
Public comment from NFH regarding measure 5601 is attached.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Comments in Support of the AOPO Performance Measurement Proposal
I appreciate the opportunity to provide comments on CBE ID: 5601 Rate of Hospital Referrals of Potential Organ Donors Made to the Organ Procurement Organization (OPO) from within the OPO’s Donation Service Area in a Calendar Year (Referral Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
Per CMS regulations, hospitals are required to refer potential organ donors to their designated Organ Procurement Organization (OPO) for evaluation. In turn, OPOs are expected to partner with hospitals by providing referral education and conducting medical record reviews to verify that appropriate referrals are occurring. For many years, OPOs have consistently performed these reviews and shared findings with their hospital partners to identify and address gaps in donor identification and referral practices. Strengthening referral processes is essential, as improving referral rates can increase the number of organs available for transplantation and help reduce deaths among patients on the transplant waiting list.
Therefore, Referral Rate is a critical performance metric for OPOs. It not only reflects an essential operational process but also serves as a key indicator of effective collaboration between OPOs and hospitals.
Under current CMS regulations, OPO performance is evaluated primarily through donation and transplantation rates. While important, these measures do not fully reflect the role of organ procurement organizations within the donation ecosystem. In particular, the transplant rate is influenced by the performance of the broader system—including transplant centers, allocation, and logistics—making it an imprecise measure of OPO-specific performance.
Additionally, the current framework establishes a forced distribution model in which OPOs are comparatively ranked, placing organizations at risk of decertification based on relative performance rather than objective standards. This zero-sum approach—unlike any other Medicare program—introduces unnecessary instability into the nation’s organ donation and transplantation system and may ultimately place patients at risk.
In my more than 20 years working for health systems and physician practices I have never witnessed the use of untested and unmodified measures that do as little to assess the performance of an organization as the current CMS measures do. True accountability and meaningful improvement require accurate, role-specific measurement. Oversight should reflect what OPOs directly control and influence—not just downstream outcomes. Strong, well-designed metrics enable better decision-making, clearer accountability, improved system coordination, and increased public trust.
This proposed measure directly assesses a core OPO responsibility.
This measure is grounded in science, developed using CMS-aligned methodologies, and independently validated in partnership with Econometrica, an independent third-party research organization. This rigorous, data-driven approach ensures objectivity, reliability, and practical applicability.
Endorsement and adoption of this measure will enable OPO leaders to better identify opportunities for process improvement, enhance performance, and maximize donation potential. Importantly, it will also strengthen transparency and reinforce public confidence in the donation system.
Most critically, aligning performance measurement with actual OPO responsibilities will reduce the risk of disruption caused by the current methodology and support a more stable, effective system—one that is better positioned to save lives through organ donation and transplantation.
Thank you for the opportunity to comment and for your consideration of these important measures.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Comments in Support of the AOPO Performance Measurement Proposal
I appreciate the opportunity to provide comments on CBE ID: 5601 Rate of Hospital Referrals of Potential Organ Donors Made to the Organ Procurement Organization (OPO) from within the OPO’s Donation Service Area in a Calendar Year (Referral Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
Per CMS regulations, hospitals are required to refer potential organ donors to their designated Organ Procurement Organization (OPO) for evaluation. In turn, OPOs are expected to partner with hospitals by providing referral education and conducting medical record reviews to verify that appropriate referrals are occurring. For many years, OPOs have consistently performed these reviews and shared findings with their hospital partners to identify and address gaps in donor identification and referral practices. Strengthening referral processes is essential, as improving referral rates can increase the number of organs available for transplantation and help reduce deaths among patients on the transplant waiting list.
Therefore, Referral Rate is a critical performance metric for OPOs. It not only reflects an essential operational process but also serves as a key indicator of effective collaboration between OPOs and hospitals.
Under current CMS regulations, OPO performance is evaluated primarily through donation and transplantation rates. While important, these measures do not fully reflect the role of organ procurement organizations within the donation ecosystem. In particular, the transplant rate is influenced by the performance of the broader system—including transplant centers, allocation, and logistics—making it an imprecise measure of OPO-specific performance.
Additionally, the current framework establishes a forced distribution model in which OPOs are comparatively ranked, placing organizations at risk of decertification based on relative performance rather than objective standards. This zero-sum approach—unlike any other Medicare program—introduces unnecessary instability into the nation’s organ donation and transplantation system and may ultimately place patients at risk.
True accountability and meaningful improvement require accurate, role-specific measurement. Oversight should reflect what OPOs directly control and influence—not just downstream outcomes. Strong, well-designed metrics enable better decision-making, clearer accountability, improved system coordination, and increased public trust.
This proposed measure directly assesses a core OPO responsibility.
The measure is grounded in science, developed using CMS-aligned methodologies, and independently validated in partnership with Econometrica, an independent third-party research organization. This rigorous, data-driven approach ensures objectivity, reliability, and practical applicability.
Endorsement and adoption of this measure will enable OPO leaders to better identify opportunities for process improvement, enhance performance, and maximize donation potential. Importantly, it will also strengthen transparency and reinforce public confidence in the donation system.
Most critically, aligning performance measurement with actual OPO responsibilities will reduce the risk of disruption caused by the current methodology and support a more stable, effective system—one that is better positioned to save lives through organ donation and transplantation.
Thank you for the opportunity to comment and for your consideration of these important measures.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Comment in Support of Rate of Referrals to OPOs Proposed Measure
I appreciate the opportunity to provide comments on CBE ID: 5601 Rate of Hospital Referrals of Potential Organ Donors Made to the Organ Procurement Organization (OPO) from within the OPO’s Donation Service Area in a Calendar Year (Referral Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
Per CMS regulations, hospitals are required to refer potential organ donors to their designated Organ Procurement Organization (OPO) for evaluation. In turn, OPOs are expected to partner with hospitals by providing referral education and conducting medical record reviews to verify that appropriate referrals are occurring. For many years, OPOs have consistently performed these reviews and shared findings with their hospital partners to identify and address gaps in donor identification and referral practices. Strengthening referral processes is essential, as improving referral rates can increase the number of organs available for transplantation and help reduce deaths among patients on the transplant waiting list.
Therefore, Referral Rate is a critical performance metric for OPOs. It not only reflects an essential operational process but also serves as a key indicator of effective collaboration between OPOs and hospitals.
Under current CMS regulations, OPO performance is evaluated primarily through donation and transplantation rates. While important, these measures do not fully reflect the role of organ procurement organizations within the donation ecosystem. In particular, the transplant rate is influenced by the performance of the broader system—including transplant centers, allocation, and logistics—making it an imprecise measure of OPO-specific performance.
Additionally, the current framework establishes a forced distribution model in which OPOs are comparatively ranked, placing organizations at risk of decertification based on relative performance rather than objective standards. This zero-sum approach—unlike any other Medicare program—introduces unnecessary instability into the nation’s organ donation and transplantation system and may ultimately place patients at risk.
True accountability and meaningful improvement require accurate, role-specific measurement. Oversight should reflect what OPOs directly control and influence—not just downstream outcomes. Strong, well-designed metrics enable better decision-making, clearer accountability, improved system coordination, and increased public trust.
This proposed measure directly assesses a core OPO responsibility.
The measure is grounded in science, developed using CMS-aligned methodologies, and independently validated in partnership with Econometrica, an independent third-party research organization. This rigorous, data-driven approach ensures objectivity, reliability, and practical applicability.
Endorsement and adoption of this measure will enable OPO leaders to better identify opportunities for process improvement, enhance performance, and maximize donation potential. Importantly, it will also strengthen transparency and reinforce public confidence in the donation system.
Most critically, aligning performance measurement with actual OPO responsibilities will reduce the risk of disruption caused by the current methodology and support a more stable, effective system—one that is better positioned to save lives through organ donation and transplantation.
Thank you for the opportunity to comment and for your consideration of these important measures.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.
Comments in Support of AOPO Performance Measure Proposal
I appreciate the opportunity to provide comments on CBE ID: 5601 Rate of Hospital Referrals of Potential Organ Donors Made to the Organ Procurement Organization (OPO) from within the OPO’s Donation Service Area in a Calendar Year (Referral Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
Per CMS regulations, hospitals are required to refer potential organ donors to their designated Organ Procurement Organization (OPO) for evaluation. In turn, OPOs are expected to partner with hospitals by providing referral education and conducting medical record reviews to verify that appropriate referrals are occurring. For many years, OPOs have consistently performed these reviews and shared findings with their hospital partners to identify and address gaps in donor identification and referral practices. Strengthening referral processes is essential, as improving referral rates can increase the number of organs available for transplantation and help reduce deaths among patients on the transplant waiting list.
Therefore, Referral Rate is a critical performance metric for OPOs. It not only reflects an essential operational process but also serves as a key indicator of effective collaboration between OPOs and hospitals.
Under current CMS regulations, OPO performance is evaluated primarily through donation and transplantation rates. While important, these measures do not fully reflect the role of organ procurement organizations within the donation ecosystem. In particular, the transplant rate is influenced by the performance of the broader system—including transplant centers, allocation, and logistics—making it an imprecise measure of OPO-specific performance.
Additionally, the current framework establishes a forced distribution model in which OPOs are comparatively ranked, placing organizations at risk of decertification based on relative performance rather than objective standards. This zero-sum approach—unlike any other Medicare program—introduces unnecessary instability into the nation’s organ donation and transplantation system and may ultimately place patients at risk.
True accountability and meaningful improvement require accurate, role-specific measurement. Oversight should reflect what OPOs directly control and influence—not just downstream outcomes. Strong, well-designed metrics enable better decision-making, clearer accountability, improved system coordination, and increased public trust.
This proposed measure directly assesses a core OPO responsibility.
The measure is grounded in science, developed using CMS-aligned methodologies, and independently validated in partnership with Econometrica, an independent third-party research organization. This rigorous, data-driven approach ensures objectivity, reliability, and practical applicability.
Endorsement and adoption of this measure will enable OPO leaders to better identify opportunities for process improvement, enhance performance, and maximize donation potential. Importantly, it will also strengthen transparency and reinforce public confidence in the donation system.
Most critically, aligning performance measurement with actual OPO responsibilities will reduce the risk of disruption caused by the current methodology and support a more stable, effective system—one that is better positioned to save lives through organ donation and transplantation.
Thank you for the opportunity to comment and for your consideration of these important measures.
Response to Public Comment
Thank you for responding in support of the endorsement of this measure. Your thoughtful comments provide additional context to the value of endorsed metrics that reflect OPO performance. We appreciate you taking the time to respond.