This measure identifies the rate of approaches per 100 referrals by the Organ Procurement Organization (OPO) to referred potential donors or their next of kin in the OPO’s donation service area (DSA) in a calendar year.
Measure Specs
General Information
The Approach Rate measure identifies the rate of approaches per 100 referrals made by the Organ Procurement Organization (OPO) to referred potential donors or their next of kin in the OPO’s donation service area (DSA) in a calendar year. We will refer to this measure as the Approach Rate measure in this report. It indicates whether the OPO had a conversation with potential donors or their next of kin about next steps in the organ donation process (if the individual has documentation of intent to be an organ donor) or about interest in becoming an organ donor. Although each organ donation is initially triggered by contact from the donor hospital as they identify a potential donor (a referral), the OPO must act on the referral to make the request of the donor. At that point, conversations will be held with the patient’s family to ensure that they are given the time, information, and support needed to make informed decisions. While donations must occur within specific medical timeframes for organs to remain viable for transplant, highly skilled OPO professionals are trained to approach these discussions with compassion and respect during moments of profound loss (AOPO, 2026).
The goal of this measure is to provide OPOs with meaningful insights into their overall discussions (approaches) with potential donors (referrals). Without a conversation about organ donation, potential donors and their next of kin may be unaware of or uninformed about donation possibilities. An approach conversation is a minimum requirement for authorization to be possible and a key step toward making more organs available to those on the transplant waiting list. A lower Approach Rate signals the need to explore potential root causes. It may indicate that an OPO needs to prioritize connecting with each referred patient or their next of kin by increasing in-hospital presence, encouraging earlier referrals to allow adequate time for approaches, or addressing other barriers. In addition to the clinical suitability of the donor, OPOs have identified that timely referrals from donor hospitals based on correct clinical triggers is a key factor impacting Approach Rate (Rahman et al., 2026b). Other issues may involve administrative tracking, resources, or training that hinder either onsite or telephonic responses to hospital referrals.
Although not every patient referral will be medically suitable for donation, OPOs must make every effort to respond to referrals and seek consent for donation in order to achieve their lifesaving mission. The literature indicated that modifiable factors related to approach can influence the approach conversation outcome. Simpkin et al. (2009) identified the skills of the individual making the request and the timing of the conversation as important factors in approach conversations. Hospital staff education should reinforce the importance of allowing the OPO—not the hospital staff—to initiate the family approach for organ donation (Ebadat et al., 2014). Inappropriately timed conversations conducted by untrained personnel can hinder approach efforts and potentially negate the referral. Maintaining clear boundaries between teams responsible for providing care and those responsible for donation is critical to patient safety, clinical integrity, and public confidence in the system (AOPO, 2026). OPOs can work with their leadership and frontline staff to establish Approach Rate benchmarks, work through challenges that are preventing approaches, and prioritize these time-sensitive and delicate conversations. The Approach Rate measure is an important metric that can provide insight into OPO performance, allowing further exploration of the dynamics surrounding approach conversations.
References:
Association of Organ Procurement Organizations (AOPO). (2026, March 13). AOPO statement on CMS guidance reinforcing safeguards [Press Release]. https://aopo.org/aopo-statement-on-cms-guidance-reinforcing-safeguards/.
Ebadat, A., Brown, C. V. R., Ali, S., Guitierrez, T., Elliot, E., Dworaczyk, S., Kadric, C., & Coopwood, B. (2014, June). Improving organ donation rates by modifying the family approach process. Journal of Trauma and Acute Care Surgery, 76(6), 1473–1475. doi:10.1097/TA.0b013e318265cdb9.
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.
Simpkin, A. L., Robertson, L. C., Barber, V. S., & Young, J. D. (2009). Modifiable factors influencing relatives’ decision to offer organ donation: Systematic review. BMJ, 338, b991. doi:10.1136/bmj.b991.
The data for the numerator and denominator of the Approach Rate measure come from the OPO’s EDR. Approach data are entered manually by OPO staff into the EDR in response to a donor referral. 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 Electronic Health Records (EHRs)—where available and in coordination with donor hospitals—for the input of patient data, including demographic and clinical data.
OPO staff determine medical suitability for donation and, if appropriate, conduct an approach conversation with the referred potential organ donor or their next of kin. This approach, whether in person, over the telephone, or via telehealth, is recorded into the OPO’s EDR system by OPO staff. Each OPO performs standardized quality assurance (QA) completeness checks of each donor case file in their EDR.
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. We learned that OPOs were not systematically coding demographic values in the same way, such as collecting age instead of date of birth, or collecting multiple race categories that differ from the census categories. We did not find differences in the approach variable itself, although some OPOs capture multiple approach attempts. Through reviews of the 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 clarified the measure specifications and definitions and engaged in discussions with each OPO to ensure that we obtained and analyzed the necessary data. Other clarifications included alignment on how missing data were handled. However, overall, we found that it was relatively straightforward to harmonize the data when we had clarifications on the data dictionary and field names.
Numerator
The numerator is the number of referred potential donors that are approached for an organ donation (terminal conversation) in the OPO’s DSA in a calendar year.
The numerator for the Approach Rate measure uses data shared directly by six OPOs. The numerator is the number of referred potential donors who are approached for organ donation (sometimes called a terminal conversation in historical literature) in the OPO’s DSA in the calendar year. An approach is defined as any type of conversation in person, over the telephone, or via telehealth with the intent to make donation a possibility after preliminary suitability has been determined by the OPO staff. The patient must have been referred to the OPO for an approach to occur.
Approaches include situations in which the patient appears to meet Donation after Brain Death criteria but is not formally declared, the patient is declared to be brain dead and appears to be a suitable donor (at least one organ), or the OPO has determined that the patient is a suitable Donation after Circulatory Death candidate and has talked to the family about organ donation.
The approach definition does not change regardless of outcome or rule-out circumstances (e.g., family declines, patient expiration, medical examiner denial, or other rule-out status). This does not include courtesy calls where a family has requested information about donation, but the OPO had already chosen not to investigate further or pursue donation.
Please refer to Attachment B for a list of definitions and acronyms associated with this measure submission.
Denominator
The denominator is the number of patients referred to the OPO in the OPO’s DSA in a calendar year.
The denominator for the Approach Rate measure is the number of patients referred to the OPO in the OPO’s DSA in the calendar year. 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 criteria generally require hospitals to refer within 1 to 3 hours of a ventilated patient identified as 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, OR
- Loss of neurological function without sedation, OR
- Patient meeting a Glasgow Coma Scale (GCS) of 5 or less, OR
- Anticipated family meeting to discuss end-of-life care, OR
- 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); OR
- Referred as outlined in each OPO-to-hospital MOU, as outlined above.
The potential donors are included in the denominator 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.
Exclusions
Non-ventilated referrals and patients older than age 80 are not included in the denominator.
Only ventilated referrals are included in the Approach Rate denominator and are calculated from the ventilator flag variable; referrals where the patient was not ventilated are removed. OPOs do sometimes receive referral calls, which they document, where a patient is determined not to be imminently near death. These are recorded in the EDR system of OPOs but are not included in this denominator. Patients whose age is greater than 80 are also removed from the set of referrals because, while a patient over age 80 may be an organ donor, these are rare circumstances, and patients over age 80 represent a large proportion of in-hospital deaths. Removing these patients as part of data cleaning reduces substantial noise in the dataset used to calculate the measure.
Measure Calculation
To calculate the numerator for the measure, using the set of referrals for an OPO for a calendar year, filter the data to only referrals where the patient was ventilated and aged 0 to of 80 years old. Next, filter to referrals where an approach occurred. Count the number of unique referrals from in subset; this is the number of approaches.
To calculate the denominator for the measure, from the set of referrals for an OPO in a calendar year, 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 in this subset; this is the number of referrals.
To calculate the measure, divide the numerator (the number of approaches) by the denominator (the number of referrals) to determine the Approach Rate. This value is multiplied by 100, as the rate is expressed as X per 100 referrals. 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/sex to evaluate whether the approaches and referrals received by the OPO reflect the gender/sex proportions of deaths in the population in the OPO’s DSA.
Finally, we stratified this measure by age. Stratification by age permits evaluation of the population breakdown of the approaches and referrals received by the OPO as compared to the proportions of potential donors in the OPO’s DSA. We hypothesized that there will be proportionally more approaches for males due to their overall higher death rates in the under-80 age group we are examining. We considered that different age concentrations for the different OPO DSAs could affect Approach Rates. Specifically, areas with older ages may have higher death rates, but that may not translate directly to higher Approach Rates. Stratifying by age allows us to observe if Approach Rates differ by age.
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 Approach Rate metric and ensure accurate and comprehensive information when developing the measure, we performed an extensive literature review 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 means for measures and amplified importance.
A thorough review of existing measures in the CMS Measures Inventory Tool (CMIT) 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 Lifecycle 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 collect additional information validating measure importance, we conducted 7 site visits of U.S. OPOs, including 45 individual interviews with OPO leadership, directors/managers, and other essential frontline staff. Econometrica conducted a qualitative analysis of all interviews that informed the development of the ecosystem map and logic model (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 the Approach Rate measure 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 Approach 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 find specific implications for an Approach Rate measure, the importance of overall appropriate measures was emphasized.
Evidence from the literature, Technical Expert Panel (TEP) and OPO stakeholder group feedback, and public comments highlighted the importance of ensuring that successful approach conversations occur for each referral to maximize the likelihood of authorization and ultimately donation (Rahman et al., 2025; Rahman et al., 2026b; Rahman et al., 2026c; O’Connor & Lind, 2025). Nicely et al. (2023) found that measures directly related to donation conversations resulted in more approaches, reapproaches, and timely conversations, leading to an increase in organ donors and more organs for transplantation. The National Academies of Sciences, Engineering, and Medicine (NASEM, 2022) also identified standardized metrics and data points for OPOs that could evaluate and improve performance of the organ transplantation system, including novel measures such as the number of referred deaths responded to by the OPO. When OPOs ensure that approach conversations occur for each referral, they increase the likelihood of authorization, leading to more viable organs being offered to transplant centers.
The Approach Rate measure is intended to quantify the extent to which meaningful approaches are being made by OPOs. OPOs receive referrals from hospitals on potential candidates for organ donation and conduct an initial review and evaluation. OPOs then respond to the referral—either in person or via telephone—and conduct further evaluation to confirm donor registration status, determine legal next of kin, conduct pre-approach conversations, have conversations and build relationships with donor families, and provide support for donation decisions. OPOs have emphasized the importance of having supportive conversations with families that occur in a timely and appropriate manner (Rahman et al., 2026a). Simpkin et al. (2009) recognized the complexity and nuance of approach conversations, including the timing of the discussion, the need for privacy, and the skills of the individual making the request. To assist the approach process, OPOs utilize dedicated tools such as the Family Readiness Assessment Tool (FRAT) to assess family readiness for donation, receptivity to prognosis, active conversations, and timing (Organ Donation and Transplant Alliance, 2023).
In collaborative sessions with our TEP and OPO stakeholder group, and in accordance with the CMS Blueprint Measure Lifecyle, we identified measure selection criteria to guide the development and testing of quality measures (CMS, n.d.; Rahman et al., 2026b; Rahman et al., 2026c). These criteria were refined and prioritized to evaluate whether a measure was regarded as meaningful, actionable, and feasible. Our TEP and OPO stakeholders also emphasized that measures under consideration should improve upon current CMS measures and be rigorously developed, evidence-based, replicable, and verifiable. In addition to these standards, our TEP and OPO stakeholders recognized the need for flexibility in new measures to reflect the evolving science and medicine of organ donation. They identified that new measures should be aligned across the transplantation system (i.e., hospitals, OPOs, and transplant centers), oriented toward optimizing transplant outcomes, developed inclusively, and assessed for the potential to promote unethical behavior (induce individuals or organizations to seek out organs that will not be used). We took these guiding criteria into account as we developed and tested the Approach Rate measure.
OPO stakeholders, as well as feedback from public comments, have reflected that OPO process measures should focus on areas within OPO control (Rahman et al., 2026c; O’Connor & Lind, 2025). The Approach Rate measure supports this goal by providing objective data to measure OPO success in this area and promote further accountability. The short-term output of this measure is anticipated to be an increase in OPO approaches to donors or next of kin. The approach process inherently involves engaging, supporting, respecting, and appreciating donor families. Additionally, successful approach conversations allow OPOs to build capability to respond to referrals and approach families efficiently and effectively. Intermediate outcomes include increased collaboration between hospitals and OPOs, fostering a culture of support for organ donation. Ultimately, these efforts culminate in the desired health outcome of an increase in the number of organs available for transplant and a shorter transplant waiting list.
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.
Nicely, B., DelliCarpini, K., & Baltierra, K. (2023, October). 121.1: Donation approach performance metrics to improve organ donation rates. Transplantation, 107(10S1), 16. doi:10.1097/01.tp.0000993064.68014.28.
O’Connor, J., & Lind, C. (2025, August 22). Public comment report [Internal document]. Econometrica, Inc., Bethesda, MD.
Organ Donation and Transplant Alliance. (2023). Family Readiness Assessment Tool (FRAT). The Alliance. https://www.organdonationalliance.org/toolbox/family-readiness-assessment-tool-frat/.
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.
Simpkin, A. L., Robertson, L. C., Barber, V. S., & Young, J. D. (2009). Modifiable factors influencing relatives’ decision to offer organ donation: Systematic review. BMJ, 338, b991. doi:10.1136/bmj.b991.
Measure Impact
The proposed Approach Rate measure will provide OPOs with a standardized mechanism to quantify their approach to donors or next of kin. Since this metric identifies when referrals were made but an approach conversation did not take place, OPOs can use the measure to direct further exploration of potential causes. There are various reasons why an approach conversation may not occur. OPOs have identified that, in addition to clinical suitability of the donor, receiving a timely referral from the donor hospital based on correct clinical triggers is a key factor impacting Approach Rate (Rahman et al., 2026a). Other issues may involve administrative tracking, resources, or training that are hindering either onsite or telephonic response to hospital referrals. A study by Valikodath et al. (2023) validated the importance of timely hospital referrals which allow OPOs to better understand family dynamics and tailor the timing and content of their approach to family discussions. Tracking approach data helps OPOs identify missed opportunities and address variances in their process.
As depicted in the logic model, this measure will also promote collaborative problem-solving with donor hospitals as OPOs evaluate missed opportunities and seek solutions. Gibson et al. (2023) demonstrated the importance of collaboration between donor hospitals and OPOs. After reviewing trauma mortality cases and performance improvement metrics with their OPO hospital liaison, they implemented a multidisciplinary performance improvement initiative to create a more donation-friendly culture for their facility. Hospital administrative engagement, staff education, and increased OPO program visibility were key approaches used. Donor conversion rates improved from 66.6 percent in 2017 to 86.1 percent in 2021. The relationship between OPOs and donor hospitals is a vital link to improving organ donation outcomes.
As noted in the previous section, OPOs track approach conversations internally, but there is currently no uniform Approach Rate measure used by all OPOs. Establishing an endorsed Approach Rate measure will facilitate benchmarking and sharing of best practices between OPOs. This is supported by the NASEM consensus study report (2022) that recommended embedding continuous quality improvement efforts into the organ donation system, including promoting the development, systematic sharing, adaptation, and use of best practices in conducting culturally sensitive conversations with all families about organ donation.
Understanding and addressing the barriers that prevent OPOs from having approach conversations with families will lead to more donation conversations and more donor organs available for transplantation. These efforts support the ultimate goal of organ donation being recognized by the public as a trusted aspect of high-quality end-of-life care.
References:
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.
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.
Valikodath, N., Lambert, A. N., Butler, A., Lebovitz, D. J., Chapman, G., Xu, M., Slaughter, J. C., Menachem, J. N., & Godown, J. (2023). The impact of donor consent mechanism on organ procurement organization performance in the United States. The Journal of Heart and Lung Transplantation, 42(5), 627–636. https://doi.org/10.1016/j.healun.2022.12.023. PMID: 36868968.
The consensus study report from NASEM (2022) identified that there is an absence of established, consensus-based measurement development and endorsement processes for organ donation measures, such as those administered by the Partnership for Quality Measurement. Specifically, the authors called for the creation of standardized performance measures, based on a consensus-driven process with limited reporting burden on health professionals or patients. Such measures would ultimately support collaboration between OPOs, donor hospitals, and transplant centers to reduce the number of patients on the transplant waiting list.
CMS currently uses two related outcome measures—Donation Rate and Organ Transplantation Rate—to assess the performance and quality of OPOs and to determine whether an OPO can be recertified or decertified. Neither of the CMS measures underwent a consensus or endorsement process. Concerns regarding these existing measures were reported during the 2020 OPO rule-making public comment period, site visit interviews, and meetings with the TEP and OPO stakeholders (CMS, 2020; Rahman et al., 2026a; Rahman et al., 2026b; Rahman et al., 2026c). One noted concern is that the current CMS measures do not fall under the OPO scope of control. OPOs facilitate the organ donation process from referral through donation but have no influence on transplant centers’ organ acceptance, which is one of the current measures they are held accountable for. OPO stakeholders have also indicated that existing CMS measures, specifically denominators for measures, do not capture donor potential. The proposed Approach Rate measure emphasizes the importance of approach conversations in the organ donation process, which falls under the purview of OPOs.
NASEM (2022) also noted that, while OPOs are responsible for discussing organ donation with a potential donor’s next of kin, there are no national standards for training OPO staff in compassionate and culturally sensitivity communication. Siminoff et al. (2024) highlighted the importance of clinician training for donor authorization conversations, due to the need for both technical expertise and strong relational communication skills. They noted that families who interact with clinicians with poor communication skills are more likely to perceive the patient’s care as poor, experience negative arousal, have inhibited grief processes, and report post-traumatic stress. A study by Traino et al. (2017), conducted across eight geographically distinct areas of the United States, found meaningful variations in the way OPO staff communicated with family decision-makers about organ donation. The study suggested that “OPO staff were missing opportunities to increase the supply of available deceased donor organs and equalize some of the regional variations in donation, conversion, and transplantation rates. The proposed Approach Rate measure can provide a standardized way for OPOs to measure their performance in conducting approaches and identify and track missed opportunities and/or staff training needs.
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.
Siminoff, L. A., Alolod, G. P., McGregor, H., et al. (2024). Developing online communication training to request donation for vascularized composite allotransplantation (VCA): Improving performance to match new US organ donation targets. BMC Med Educ, 24, 77. https://doi.org/10.1186/s12909-024-05026-9.
Traino, H. M., Molisani, A. J., & Siminoff, L. A. (2017). Regional differences in communication process and outcomes of requests for solid organ donation. American Journal of Transplantation, 17(6), 1620–1627.
As part of establishing the meaningfulness of this measure, we conducted 7 OPO site visits, totaling 45 interviews with OPO leadership, directors/managers, and other essential frontline staff (Rahman et al., 2026a). We also conducted a qualitative study of 16 participants to explore the perspectives of donor families, transplant recipients, and OPO stakeholders (Arellano et al., 2025).
During our conversations, OPOs reported utilizing operational best practices for approach conversations to maximize the likelihood of success. These included hiring qualified and trained family services staff, responding to referrals from donor hospitals in a timely manner, conducting in-person approaches to build relationships with families, and engaging in relationship-building and education with donor hospitals regarding appropriate approach conversations and support.
During our OPO site visits, all seven OPOs mentioned utilizing a dedicated family services team responsible for activities related to donor families, including initiating conversations about organ donation and providing donor family guidance and support services. These teams receive tailored orientation and training and are often required to have specialized educational backgrounds (such as social work) due to the intricacies of this work.
The importance of communication was highlighted during our discussions with organ donor and recipient families (Arellano et al., 2025). Families noted that it is important for OPO staff to recognize the emotional state of donor families, who may struggle to process extensive information during a highly stressful time. The Approach Measure reflects the importance of the first contact with OPOs for families, emphasizing that effective communication is essential to both the family decision-making process and their overall experience. The need for both technical expertise and strong relational communication skills among OPO staff has been previously identified as critical for these sensitive conversations (Siminoff et al., 2024).
OPOs view the proposed Approach Rate measure as meaningful for the target population of patients and families of organ donation, noting that it will generate valuable information on Approach Rates that can improve care decisions.
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.
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.
Siminoff, L. A., Alolod, G. P., McGregor, H., et al. (2024). Developing online communication training to request donation for vascularized composite allotransplantation (VCA): Improving performance to match new US organ donation targets. BMC Med Educ, 24, 77. https://doi.org/10.1186/s12909-024-05026-9.
Performance Gap
The measure is being submitted for initial endorsement.
Currently, CMS assesses OPO performance using two unendorsed quality measures: Donation Rate and Organ Transplantation Rate. A measure of Approach Rates provides essential information to OPOs to support quality improvement efforts directed at increasing approaches to their referrals.
The data source is the OPO EHR. 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 Approach Rates per 100 for our 6 test site OPOs are presented in Exhibit 3: Approach Rates by OPO in Attachment B.
The Approach Rates per 100 for our 6 test site OPOs are presented in Exhibit 3: Approach 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. All data elements for the Approach Rate measure are available 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 donor referrals that lead to 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 the referral was 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 patterns, evaluate missed opportunities, and assess process performance at key decision points.
While these issues do not impede Approach Rate measure calculations, they can limit OPOs’ internal visibility into possible operational improvements. All of 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 implement the Approach Rate measure as defined. Our test sites indicated that the data for the Approach Rate measure are already being tracked and collected by OPOs, although some manual data entry is required because some referrals (denominator) are provided via telephone rather than electronically. There is also manual labor involved for hospital record reviews, which OPOs are already conducting. The donation coordinators at OPOs track their approach conversations in the EDR with the outcome of the conversations (authorization status). There is no disruption to workflow, and no significant barriers were reported. Feedback from the TEP, stakeholders, and public comments did not indicate a concern with the burden of implementation for the Approach Rate measure.
The 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 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.
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 confirm that an Approach Rate measure provided meaningful information to OPOs about their efforts to approach every eligible referral (Rahman et al., 2026a; Rahman et al., 2026b). These collaborations ensured that the data elements were captured in EDRs and that many OPOs were already tracking these data points for internal performance benchmarking and improvement efforts, further demonstrating the feasibility of this measure.
We refined our initial definition of an approach conversation to reflect that approaches occur onsite and virtually and are not dependent on the ultimate outcome of the donation (i.e., medical rule-out). However, our data collection from test site OPOs and subsequent conversations with OPO staff revealed that the definition of an approach may be used differently across OPOs. Once we confirmed definitions and the variables used for approaches with each OPO, we were able to calculate the measure rate. For the Approach Rate measure to be comparable across OPOs, alignment on what is tracked (and how that information is tracked generally) will be key to the measure’s broad applicability.
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, approach conversation date and outcome, authorization outcome, and donation result. Gender, age, and race were also used for stratification.
All data are 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.
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 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 and by participating 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 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 Transplant measures (based on 2023 CMS data) (OPTN, 2025; CMS, 2025). Five of the 6 OPOs have DSA coverage in more than 1 state, bringing the total count of states in this analysis to 13 states.
Exhibit 4 in Attachment B includes the characteristics of the six test OPO. The 6 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 (CMS). (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
Approach is a key step in moving a referred potential organ donor to an organ donor. However, not all referred organ donors are appropriate to approach. OPOs determine whether to approach a donor based on a number of factors, including age, prognosis/time to death, health status, first person authorization or availability of next of kin for authorization, and facility considerations (e.g., whether organs can be procured in a safe and timely manner at the current facility or whether the donor could be moved to a donor care unit). Under 42 CRF 486.344, the medical director for each OPO is responsible for potential donor evaluation, which includes these factors that may influence donor acceptance. While multiple factors affect whether an approach is made, approach data are generally reliable.
Person or Encounter Level
Approach is recorded by OPOs as a yes/no variable, with additional variables recording details regarding the manner of the approach by OPO staff (i.e., telephone versus in person), the timing of approach (i.e., time and date), and the results of each approach if multiple approaches were made. Multiple approaches may be made if a family is undecided, traveling to the patient’s location, or awaiting additional medical information regarding their loved one’s prognosis. Approaches are always made by OPO staff and never by hospital staff, as required by law and as is a best practice.
OPOs utilize a protocol for approach, including what information must be obtained in advance by the OPO staff member and scripts for the approach, followed by recording each approach in the electronic donor record. The approach protocol varies by type of potential donor—brain death or cardiac death. Some OPOs use a system of confirmation, where each approach is discussed with a supervisor at OPO headquarters in real time, then made, and then discussed, allowing data to be checked during the process of the approach. Most OPOs also report using a system of checks in their donor record. One OPO provided us with an unpublished report of these checks, showing that in one quarter 92 of 95 donor records, or 96 percent, had completed all items associated with properly recording an approach (please refer to Exhibit 6 in Attachment B).
While we are aware that some prior studies have found that OPO data cannot easily be harmonized across OPOs (Adam et al., 2026), we did not find this to be true. We found similar or identical fields for approach and authorization. This may be because OPOs have implemented an internal project called UNION, which promotes the standardization of their data. The paper by Adam et al. (2026) uses older data from 2015 through 2021 while our measure testing used data from 2021 through 2024. Additionally, as OPOs roll out this approach measure, OPO electronic donor record providers are participating in an activity to further standardize the capture of demographic data on donors and will use a self-auditing tool to validate their approach data uniformly across all OPOs.
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 approaches meeting all applicable inclusion and exclusion criteria, obtained from OPO data) and the denominator (count of referrals meeting all applicable inclusion and exclusion criteria, also 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. The Approach Rate 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 Approach 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:
Adam, H., Pollard, T., Suriyakumar, V., et al. (2026). Organ retrieval and collection of health information for donation: The ORCHID dataset. Scientific Data, 13, Article 120. https://doi.org/10.1038/s41597-025-06435-1.
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.
U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services.t(2026). 42 C.F.R. § 486.344: Condition: Evaluation and management of potential donors and organ placement and recovery. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-486/subpart-G/section-486.344.
Person or Encounter Level
Please refer to Section 5.2.2 Methods of Reliability Testing.
Accountable Entity Level
The Approach Rate reliability as estimated by the average ICC(1) value has a mean value of 0.9845, with a 95-percent confidence interval of [0.9839, 0.9851].
Person or Encounter Level
Please refer to Section 5.2.2 Methods of Reliability Testing.
Accountable Entity Level
The estimated Approach Rate reliability is 0.9845, 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
Approach is a key step in moving a referred potential organ donor to an organ donor. However, not all referred organ donors are appropriate to approach. OPOs determine whether to approach a donor based on a number of factors, including age, prognosis/time to death, health status, first person authorization or availability of next of kin for authorization, and facility considerations (e.g., whether organs can be procured in a safe and timely manner at the current facility or whether the donor could be moved to a donor care unit). Under 42 CRF 486.344, the medical director for each OPO is responsible for potential donor evaluation, which includes these factors that may influence donor acceptance. While multiple factors influence if an approach is made, approach data are generally reliable and valid.
Person or Encounter Level
Approach is recorded by OPOs as a yes/no variable, with additional variables recording details regarding the manner of approach by OPO staff (i.e., telephone versus in person), the timing of approach (i.e., time and date), and the results of each approach if multiple approaches were made. Multiple approaches may be made if a family is undecided, traveling to the patient’s location, or awaiting additional medical information regarding their loved one’s prognosis. Approaches are always made by OPO staff and never by hospital staff, as required by law and as is a best practice.
OPOs utilize a protocol for approach, including what information must be obtained in advance by the OPO staff member and scripts for the approach, followed by recording each approach in the electronic donor record. The approach protocol varies by the type of potential donor—brain death or cardiac death. Some OPOs use a system of confirmation, where each approach is discussed with a supervisor at OPO headquarters in real time, then made, and then discussed, allowing data to be checked during the process of the approach. Some OPOs also use field checks, with two staff members involved in each approach (one observing the other). Most OPOs also report using a system of checks in their donor record, as discussed in Section 5.2.2 Method(s) of Reliability Testing above.
Additionally, OPOs report utilizing advanced methods for validating the approach data they obtain at the person level and at the entity level, such as the use of an AI dashboard to predict the expected outcome of an approach based on the potential donor’s age, race, and donor type, and compare the performance of each person conducting approaches to expected rates to identify problems in the data and performance.
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 approaches—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 approaches were provided by the six participating OPOs, and they are not subjective or constructed. The denominator is the number of referrals. For these datasets, missing values were mostly not an issue.
Criterion validity: To test concurrent validity, we compared the approach data to the referral data to ensure that the approach numbers were less than referrals, as expected (see Table 1). We queried OPOs to request information on the magnitude of the difference, and the OPOs provided an explanation regarding how they determine if an approach should be made from a referral. This added confidence that the OPO is capturing the expected approaches 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 |
| Approaches Reported by OPOs | 2,909 | 6,890 | 953 | 2,407 | 2,395 | 1,560 |
| Difference (Count) between Referrals reported by OPOs and Approaches | 15,825 | 12,309 | 6,178 | 10,480 | 11,116 | 7,074 |
| Difference % | 146% | 94% | 153% | 137% | 140% | 139% |
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. We used a simple regression analysis to determine the extent to which approach rate determines authorization rate (see Table 2). 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. Approach Rate vs. Authorization Rate, R-Squared Value = 0.4119
| OPO 1 | OPO 2 | OPO 3 | OPO 4 | OPO 5 | OPO 6 | |
| Approach Rate | 16 | 36 | 13 | 19 | 18 | 18 |
| Authorization Rate | 64 | 47 | 59 | 52 | 73 | 63 |
Reference:
U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services. (2026). 42 C.F.R. § 486.344: Condition: Evaluation and management of potential donors and organ placement and recovery. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-486/subpart-G/section-486.344.
Person or Encounter Level
Please refer to Section 5.3.3 Methods of Validity Testing. We relied on OPO internal unpublished reports showing that in one quarter, 92 of 95 donor records, or 96 percent, had completed all items associated with properly recording an approach. OPOs are implementing a uniform system of auditing for data validity moving forward. The audit tool is available upon request.
Accountable Entity Level
Please refer to Exhibit 7 in Attachment B for details of the testing results. We compared the MCOD data for each DSA by race, gender, and age with the OPO data. We compared the proportions from the MCOD file to the referral counts provided by each participating OPO. By comparing the relative proportions of an OPO’s vented referral counts to the estimated potential donor pool, the team could observe how much they varied from the MCOD population estimate.
Person or Encounter Level
Please refer to Section 5.3.3 Methods of Validity Testing.
Accountable Entity Level
Please see Exhibit 7 in Attachment B for the results.
We observed that the proportions of approaches and referrals did vary somewhat from the MCOD “baseline” data. For age, while the proportions varied, the relative shape of the distribution was similar for the approach and MCOD data. Most observations fell in the 25 to 69 age range. For race, proportions were very similar across all groups, with the majority of observations being Non-Hispanic White. Similarly, the majority of observations were male, constituting 61 percent of approaches and 64 percent of the MCOD data.
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 (CMS, 2023; CMS, 2025; NQF, 2014; Vogel & Chen, 2018), but 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 to understand how the 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 Approach 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 Approach Rates. Stratifying by age allows us to observe if Approach Rates differ by age. One issue for OPOs is obtaining full participation in the donation process for all races. We have stratified the rates by race to better understand if there are racial differences in Donation Rates and if minorities have lower Approach Rates. For gender, generally men have higher death rates at younger ages. Observing the differences by gender will allow us to see if there are noticeable differences in approaches by gender and understand if gender composition affects the measure.
References:
Centers for Medicare & Medicaid Services. (2023, August). Risk adjustment and risk stratification in quality measurement. Supplement material to the CMS Measures Management System (MMS) Hub. https://mmshub.cms.gov/sites/default/files/Risk-Adjustment-in-Quality-Measurement.pdf.
Centers for Medicare & Medicaid Services. (2025, May). Ways to account for risk. CMS Measures Management System (MMS). https://mmshub.cms.gov/measure-lifecycle/measure-specification/risk-adjustment/ways-to-account-for-risk.
National Quality Forum. (2014, August). Risk adjustment for socioeconomic status or other sociodemographic factors. National Quality Forum. https://digitalassets.jointcommission.org/api/public/content/ed011a6479574761b11211d55eae0bc3?v=67b20abf.
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.
Vogel, W. B., & Chen, G. J. (2018). An introduction to the why and how of risk adjustment. Biostatistics & Epidemiology, 4, 84–97. https://doi.org/10.1080/24709360.2018.1519990.
The measure was stratified by age, race, and gender. The distributions for those variables are shown in Exhibit 8 in Attachment B.
We selected the stratification variables based on an understanding of what can impact the organ donation process.
In this section, we present Approach Rates stratified by age, race, and gender. Please refer to Exhibits 9–14 in Attachment B for the interpretation of our results.
Use & Usability
Use
The Approach Rate measure identifies the rate of approaches per 100 referrals made by the Organ Procurement Organization (OPO) to referred potential donors or their next of kin in the OPO’s donation service area (DSA) in a calendar year. The goal of this measure is to provide OPOs with meaningful insights into their overall discussions (approaches) with potential donors (referrals). Without a conversation about organ donation, potential donors and their next of kin may be unaware of or uninformed about donation possibilities. An approach conversation is a minimum requirement for organ donation authorization to be possible. The Approach Rate measure is an important metric that can provide insight into OPO performance, allowing further exploration of the dynamics surrounding approach conversations.
The OPO is the care setting for which this measure is specified and tested. 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 cultivation of best practices; public reporting; and regulatory and accreditation programs. 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 (CMS, 2023; CMS, 2025; NQF, 2014; Vogel & Chen, 2018), but 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 the OPOs differed across groups of interest and where there are some historical patterns of different donation rates.
During our conversations with OPOs, they reported using operational best practices for approach conversations to maximize the likelihood of success (Rahman et al., 2026a). These included hiring qualified and trained family services staff, responding to referrals from donor hospitals in a timely manner, conducting in-person approaches to build relationships with families, and engaging in relationship-building and education with donor hospitals regarding appropriate approach conversations and support. OPOs view the proposed Approach Rate measure as meaningful for the target population of patients and families involved in organ donation, noting that it will generate valuable information on Approach Rates that can improve care decisions.
References:
Centers for Medicare & Medicaid Services. (2023, August). Risk adjustment and risk stratification in quality measurement. Supplement material to the CMS Measures Management System (MMS) Hub. https://mmshub.cms.gov/sites/default/files/Risk-Adjustment-in-Quality-Measurement.pdf.
Centers for Medicare & Medicaid Services. (2025, May). Ways to account for risk. CMS Measures Management System (MMS). https://mmshub.cms.gov/measure-lifecycle/measure-specification/risk-adjustment/ways-to-account-for-risk.
National Quality Forum. (2014, August). Risk adjustment for socioeconomic status or other sociodemographic factors. National Quality Forum. https://digitalassets.jointcommission.org/api/public/content/ed011a6479574761b11211d55eae0bc3?v=67b20abf.
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.
Vogel, W. B., & Chen, G. J. (2018). An introduction to the why and how of risk adjustment. Biostatistics & Epidemiology, 4, 84–97. https://doi.org/10.1080/24709360.2018.1519990.
Usability
As a process measure, the Approach Rate provides OPOs with meaningful insights into their level of effort (approaches) for potential donors (referrals). The use of established and consistent definitions, clinical triggers, and documentation practices to ensure accuracy in measure utilization is essential for this process.
A robust internal quality improvement program can assist OPOs in identifying root causes and developing targeted strategies to improve their Approach Rate metric. By using a Plan, Do, Study, Act framework, OPOs can implement small tests of change and alter approach strategies for broader implementation based on outcomes. The following list of potential activities or tests of change that OPOs can implement are realistic and attainable:
- Maintaining a visible presence in donor hospitals to build relationships and collaboration.
- Evaluating all OPO staff orientation and training materials for the inclusion of effective approach strategies and communication techniques.
- Collaborating with donor hospitals to ensure that referral criteria are understood and utilized correctly.
- Utilizing readiness assessments and tools to evaluate family receptivity to donation.
- Offering structured Q&A content and supporting materials to improve family understanding and decision‑making.
- Engaging hospital leadership to help establish donation as a priority in their facility.
- Performing in-depth case reviews of all missed approaches to identify patterns in the data and guide focused areas for training.
We believe that the benefits of the proposed Approach Rate measure outweigh any potential unintended consequences associated with its use. However, we identified two potential unintended consequences through conversations with OPOs.
One potential unintended consequence is that OPO staff may make approaches that are inappropriately timed or involve patients who are medically unsuitable for organ donation. This can be prevented or mitigated through adequate OPO staff orientation and training (Siminoff et al., 2024) and close collaboration with hospital staff regarding donor status and donation eligibility. Additionally, the use of dedicated tools such as the Family Readiness Assessment Tool (FRAT) can help determine family readiness for donation, receptivity to prognosis, active conversations, and timing (Organ Donation and Transplant Alliance, 2023).
A second potential unintended consequence is that well-intentioned hospital staff may initiate an approach conversation with a family instead of OPO staff. Conversations conducted by untrained personnel who are not aligned with OPO donation practices can hinder approach efforts and negatively affect referral outcomes. Maintaining clear boundaries between teams responsible for patient care and those responsible for donation is essential. Through education and ongoing communication, OPOs can work with hospital leadership and frontline staff to identify and resolve challenges related to approaches.
Although not every patient referral will be medically suitable for donation, OPOs must make every effort to ensure that successful approach conversations occur for each referral in order to maximize the likelihood of authorization and ultimately donation. Overall, OPOs expressed that the benefits of the Approach Rate measure outweigh any potential consequences, which can be effectively mitigated by the strategies outlined above.
References:
Organ Donation and Transplant Alliance. (2023). Family Readiness Assessment Tool (FRAT). The Alliance. https://www.organdonationalliance.org/toolbox/family-readiness-assessment-tool-frat/.
Siminoff, L. A., Alolod, G. P., McGregor, H., et al. (2024). Developing online communication training to request donation for vascularized composite allotransplantation (VCA): Improving performance to match new US organ donation targets. BMC Med Educ 24, 77. https://doi.org/10.1186/s12909-024-05026-9.
Comments
Staff Preliminary Assessment
CBE #5602 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 organ transplant authorizations, would be positive because the measure would provide Organ Procurement Organizations (OPOs) with a standardized means to assess their success in approaching referred patients or their next of kin. 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 Approach Rate. Approaching potential donors or their next of kin represents 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. More successful approach conversations could support an increase in the number of organs available for transplant.
- The developer described a sufficient search process and 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 OPOs control.
Description of patient input supports the conclusion that Approach 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 the developer presents evidence approach is an essential step in they organ donation process and that OPOs can improve approach outcomes, they do not present evidence that a higher approach rate will lead to more successful donations. The committee should seek clarification on what an appropriate Approach Rate should be and whether any empirical evidence exists which ties higher approach rates to more successful transplants.
Rationale:
- This new measure meets all criteria for 'Met' for importance due to the significant problem it addresses, its robust evidence base, a documented performance gap, justifiable advantages over existing measures, and a well-articulated logic model, making it essential for addressing Approach Rate among OPOs.
- There is at least moderate confidence that the business case is adequate, i.e., that implementing a standardized measure of Approach 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 how, while there were initially challenges with constructing some variables needed for the measure, those challenges were resolved by creating clearer definitions for these variables. For example, they refined the definition of an approach to include both virtual and onsite approaches. The result is a measure that is specified using data OPOs routinely collect and store electronically.
- 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 for OPOs to implement the measures as defined.
- Test sites indicate the data are already being collected and tracked by OPOs. Some of this data is collected manually because some referrals are placed by telephone. 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 asserts 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
- The developer described the costs and burden associated with data collection and data entry, validation, and analysis from the perspective of OPOs (the measured entity). However, the committee may wish to consider potential burdens of implementing this measure for hospitals, health care providers, and potential donors or next of kin (e.g., hospital resources required to facilitate approach, burden related to patients unlikely to be eligible for organ donation).
- Test sites utilized two different Electronic Donor Resources (EDRs). The application could be strengthened by 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.
Limitations
- The developer did not perform the required elements of reliability testing for this new measure. Specifically, they did not conduct person or encounter-level reliability testing or provide sufficient evidence of person or encounter-level reliability and they did not provide a rationale for not doing so.
- 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 'Not Met But Addressable' for reliability because the required reliability testing was not performed for person- or encounter-level reliability. However, the identified limitations are deemed addressable, as the developer may consider calculating the split-half reliability using ICC for each of the OPOs for which the developer has data. By addressing this issue, there is potential for the measure to meet the threshold for person- or encounter-level reliability.
Strengths:
- The developer referenced a report received from one OPO stating that for 96% of cases reviewed in one quarter (date of testing data not provided), the approach (i.e., the numerator) was shown to be fully documented. The developer also provided a screenshot of a database view used by the OPO that shows each element of the approach process being documented in a structured field; this highly structured process supports the validity of the 'approach' data element for this particular OPO.
Limitations
- As there is no external "gold" standard to compare with approaches documented by OPOs, the principal risks to validity of the numerator are non-standardized processes across OPOs for documenting authorizations and the use of unstructured fields to capture data. The developer characterized the processes OPOs use to ensure the validity of data elements as sufficient, but they also acknowledged there is currently no standardized approach across OPOs. While the developer was able to share limited evidence of data element validity at one OPO, the documentation provided by one OPO may not reflect data element validity at other OPOs.
Regarding the validity of data elements in the denominator, this measure shares most of those same data elements with CBE 5601 (referrals), and the limitations of data element validity for CBE 5601 should be considered here as well. - 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 in 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 maintain a visible presence in donor hospitals, ensure staff orientation materials and training include effective approach strategies, collaborate with donor hospitals on referral criteria, engage with hospital leadership to establish donation as a priority, and perform in-depth case reviews of missed approaches to identify patterns and guide focused areas for training.
- The developer described potential unintended consequences. Unintended consequences could include OPO staff making approaches that are inappropriately timed or involve patients who are medically unsuited for organ donation and well-intentioned hospital staff initiating approach conversations with family rather than OPO staff. The developer has plausibly argued that the measure’s benefits outweigh the potential unintended consequences they identified.
Limitations
- None identified.
Rationale:
- This new measure is rated ‘Met’ for use and usability because there is a clear plan for use in at least one accountability application and the measure provides actionable information for improvement. The developer reported that entities can address potential unintended consequences through educating OPO staff and hospital employees to ensure approach conversations are handled appropriately.
Committee Independent Review
Important measure with more details needed
Importance
Important process measure that links referrals to outcomes through communication quality. Metric is an unmet need due to lack of standardization across OPOs and no existing measure to serve as a quality indicator/benchmark. The literature synthesis states that a higher approach rate leads to more successful donations but this is described qualitatively with no data to support this claim. Recommend adding the evidence to support this claim, and bolster the measure's importance.
Closing Care Gaps
optional - not completed this year.
Feasibility Assessment
Little to no additional burden to implement the Approach Rate measure as defined. Six test sites indicated that the data for the Approach Rate measure are already being tracked and collected by OPOs. We will be disseminating instructions to OPOs regarding the variables for use in this measure, and a separate project is working on updates to OPO EDRs. No licensing, fees, or proprietary information.
Scientific Acceptability
The Approach Rate reliability as estimated by the average ICC(1) value has a mean value of 0.9845, with a 95-percent confidence interval of [0.9839, 0.9851], above the 0.6 threshold. Did not conduct person or encounter-level reliability testing.
No gold standard for validity comparison makes it difficult to determine whether the limited results presented from one OPO is sufficient to translate to others. Also relied on unpublished reports as their data source. Did not include rationale for risk stratification variables beyond this statement: "We selected the stratification variables based on an understanding of what can impact the organ donation process," which is not grounded in the literature.
Use and Usability
The developer lays out the benefits of using operational best practices for approach conversations, and the valuable information it could provide for process improvements. There are no fees and it is not proprietary. There are some concerns related to quality of conversations vs. quantity in trying to achieve high performance. While the developers mention training, there should be other safeguards in place to protect from 100% approach rates that either harm trusted relationships and/or create staff burnout.
Approaches for an Organ Donation in the Organ Procurement (#5602
Importance
The applicant has presented the importance of a measure to capture the effort to approach referred organ donors.
Concern: Assuring standardization of numerator and denominator data is a huge challenge and some of the differences by the different programs may largely be due to data issues however savvy the cleaning ma be.
Closing Care Gaps
Not required.
Feasibility Assessment
Data availability and relatively easy access to data make make it feasible to implement the measure. However, standardization of the data and sensitivity of the subject may make public reporting challenging.
Scientific Acceptability
The applicant has made an extensive effort to to address the scientific merits of the measure. While the approaches are well presented, the predictive validity of the measure may be low to endorse this as public measure at this stage.
Also, I couldn't reproduce the "Difference %" from the data provided. The applicant may make that clearer to this reviewer.
There are a few concerns here that can potentially be addressed.
- Classifying race as Non-Hispanic White and Non-White. No clear reason was provided for this classification. It appears contrary to other conventions for population groupings. This may obscure population differences while casting doubt on the validity of the measure.
- Exhibit 7, MCOD Potential Donors (Referral Rate): Reviewing the last column heading is advised. It looks more like a simple column percentage that is presented. If the applicant provides "rates" (e.g., percent of Non-Hispanic White vs Non-White approached out of those referred for each group), the differences would have been more informative. The numbers we see are reflections of differences due to relative population sizes.
Use and Usability
This measure may need additional data with standardization of common variables across groups in order to be used for public reporting. Adjusting nuances in definitions (e.g., for the denominator) as the applicant did may harm this timely and important need for a measure.
Summary
Organ donation is an important area that is both challenging which needs better tracking and accountability. The proposed measure is a very useful first start for public reporting except that data should first be uniformly collected, potential donor approaches are standardized and that the measure appeals to the public as well as related organizations to make it successful.
Also, the name of the measure "Approach Rate", should also be examined. In order for a measure to be a rate, specific conditions are generally met. For this measure to be considered a rate, one has to assume that all referrals are at risk for approach. I didn't feel that was true from the denominator description.
While I support the effort, I do not recommend its use in its current form at this time.
unmet but addressable issues-important measure
Importance
General: “The Approach Rate measure identifies the rate of approaches per 100 referrals made by the Organ Procurement Organization (OPO) to referred potential donors or their next of kin in the OPO’s donation service area (DSA) in a calendar year.“ Importance: “A thorough review of existing measures in the CMS Measures Inventory Tool (CMIT) indicated that there were no measures comparable to the one proposed for endorsement (CMIT, n.d.).“” The CMS Blueprint Measure Lifecycle was used to guide our work.” Impact: “Since this metric identifies when referrals were made but an approach conversation did not take place, OPOs can use the measure to direct further exploration of potential causes.”
Closing Care Gaps
optional
Feasibility Assessment
“All OPOs track their data electronically in EDRs. All data elements for the Approach Rate measure are available in structured fields.”
Scientific Acceptability
“The reliability testing and stratification used the same data that were used to construct this measure.” Done at both patient and entity level.
Done at both patient and entity level. Done for both face and criterion validity,
Risk adj. –“ Because this is a process measure, risk adjustment may obscure critical information.“
Use and Usability
Use: currently not in use; future use for public reporting, accreditation, and quality improvement.
Usability: “The use of established and consistent definitions, clinical triggers, and documentation practices to ensure accuracy in measure utilization is essential for this process.”
Summary
Similar to the other 3 measures, this measure is important. If concerns are addressed accept. Note: 5 organizations supported.
Great measure with some further explanation needed
Importance
The principle of this measure is important, but I am having difficulty understanding how this piece will make a difference. There are ethical considerations in measuring conversations and accounting for when and how this can be appropriate. How does it account for patients that are non-donors? What if the family does not believe in donation? Are there evidence based processes that facilities can establish to support a measure of this kind?
Closing Care Gaps
Feasibility Assessment
Unclear if there is an evidence based process that was tested.
Scientific Acceptability
Agree with Batelle staff.
Agree with Batelle staff.
Use and Usability
I struggle to see the usability of this measure. In addition, how will the ethical side of having this type of conversations be accounted for. How is it useful if there is no established process to recommend?
Summary
I truly believe this is an important topic to discuss. However, I do not believe 4 measures that have different sides of this is the way to go. I understand this is a difficult topic to measure and especially account for ethics. Suggest a review by a third party on the ethics of this, as well as roundtable discussion and documentation of possible alternative measures. In addition, exclusions need to be reviewed to include those in the non-donor lists.
(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
Optional
Feasibility Assessment
The description states that "While we are aware that some prior studies have found that OPO data cannot easily be harmonized across OPOs (Adam et al., 2026), we did not find this to be true. We found similar or identical fields for approach and authorization. This may be because OPOs have implemented an internal project called UNION, which promotes the standardization of their data. The paper by Adam et al. (2026) uses older data from 2015 through 2021 while our measure testing used data from 2021 through 2024. Additionally, as OPOs roll out this approach measure, OPO electronic donor record providers are participating in an activity to further standardize the capture of demographic data on donors and will use a self-auditing tool to validate their approach data uniformly across all OPOs" - assuming that this is true, then should be feasible to implement. The developer states that they "found similar or identical fields" which may be from a project to standardize data. I would be curious if this is true across all OPOs or just the 6 that participated in this study.
Scientific Acceptability
Use and Usability
With potential addition of 4 process metrics (5601, 5602, 5603, 5604) need to be cognizant of the cumulative burden of measuring all of these measures and for local teams to implement improvements across all 4 measures.
(No subject)
Importance
Agree with staff assessmy
Closing Care Gaps
Optional
Feasibility Assessment
Scientific Acceptability
Agree with staff assessment
Agree with staff assessment
Use and Usability
It would be helpful to understand how one would assess if the unintended consequences are taking place.
Important Measure
Importance
Clear logic model that describes the relationship between the demand for organs, receipt and management of referrals, and outcomes. Comprehensive lit review and no similar measures exist.
Closing Care Gaps
Not addressed by developer
Feasibility Assessment
Routinely collected data in current processes; Little to no additional burden for collection; No barrier to use (no licensing fee). Measure can be implemented for performance improvement in a health care facility.
Scientific Acceptability
Developer should address person and/or encounter level reliability to meet thresholds for endorsement.
Agree with Battelle's comments
Use and Usability
Measure is not currently in use but can be incorporated into QAPI activities.
Summary
This new measure addresses a significant problem, uses strong evidence, has identified a gap in performance measurement for this population. Encourage developer to strengthen scientific acceptability sections to improve likelihood for endorsement.
(No subject)
Importance
Feasibility Assessment
Scientific Acceptability
addressable but unclear measure should be endorsed at this time, vs. come back with complete testing
Public Comments
Comment in Support of CBE ID 5602
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: 5602
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 Approach 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 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. To ensure the measure is implemented across OPOs consistently, a self-audit tool has been developed for OPOs to use to sample their data quarterly, validate it, and collect their data quality rate. These self-audits will not only serve to ensure data validity and reliability but will also help OPOs identify the root causes of data inaccuracies or errors to promote continuous quality improvement in their data.
Regarding accountability, the 53 OPOs consulted to identify and develop measures for this initiative agreed that a standardized approach to calculating Approach Rate is a valuable tool for quality improvement, as well as for potential use in external accountability mechanisms. The potential uses of approach measurements were reviewed in the literature review conducted and cited in this measure and are available online. See, for example, Levan, M. L., Massie, A. B., Trahan, C., Hewlett, J., Strout, T., Klitenic, S. B., Vanterpool, K. B., Segev, D. L., Adams, B. L., & Niles, P. (2022). Maximizing the use of potential donors through increased rates of family approach for authorization. American Journal of Transplantation, 22(12), 2834–2841. https://doi.org/10.1111/ajt.17194
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.
Versiti Public Comment CBE ID: 5602 Rate of Referred Patients
Public comment from Versiti Blood Health, Inc. attached regarding measure 5602.
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
Please 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.
Public Comment CBE ID: 5602 Rate of Referred Patients
Mid-South Transplant Foundation Public Comment on CBE ID: 5602 Rate of Referred Patients. 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:5602
Thank you for the opportunity to comment on this.
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.
ConnectLife Public Comment on CBE 5601-5604
ConnectLife Public 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.
HonorBridge Public Comment, CBE 5602
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.
PQM Public Comment CBE ID 5602
Public comment from Iowa Donor Network attached regarding measure 5602.
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
Public comment from Donor Network of Arizona regarding measure 5602 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: 5602 Rate of Referred Patients that are Approached for an Organ Donation in the Organ Procurement Organization’s Donation Service Area in a Calendar Year (Approach Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
The opportunity for organ donation is limited and begins when a donor hospital contacts the Organ Procurement Organization (OPO) after identifying a potential donor. Following this referral, the OPO is responsible for promptly evaluating the case and advancing the donation process. OPOs employ highly trained professionals who engage with potential donor families in a respectful, compassionate, and culturally sensitive manner. During these approach conversations, families are provided with the information, support, and time necessary to make an informed decision about donation. An approach conversation is a prerequisite for authorization and a critical step in increasing the number of organs available for transplantation. The Approach Rate serves as a meaningful metric for evaluating how consistently these conversations are occurring. Lower Approach Rates may signal opportunities to examine root causes and improve processes, while higher rates can help identify and reinforce effective practices.
As such, the Approach Rate is a critical performance metric for OPOs. It reflects a core operational function and plays a vital role in improving donation outcomes and saving lives.
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: 5602 Rate of Referred Patients that are Approached for an Organ Donation in the Organ Procurement Organization’s Donation Service Area in a Calendar Year (Approach Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
The opportunity for organ donation is limited, beginning when a hospital contacts their designated Organ Procurement Organization (OPO) after identifying a potential organ donor. Following the referral, the OPO is responsible for promptly evaluating the situation and advancing the donation process. OPOs employ highly trained professionals who engage with potential donor families in a respectful, compassionate, and culturally-sensitive manner. During these approach conversations, OPO professionals provide families with the information, support, and time necessary to make an informed decision about donation. An approach conversation is a prerequisite for authorization and a critical step in increasing the number of organs available for transplantation. The Approach Rate serves as a meaningful metric for evaluating how consistently these conversations are occurring. Lower Approach Rates may signal opportunities to examine root causes and improve processes, while higher rates can help identify and reinforce effective practices.
As such, the Approach Rate is a critical performance metric for OPOs, reflecting a core operational function and playing a vital role in improving donation outcomes and saving lives.
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 OPOs 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, 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 the work 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. It 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. 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.
Rate of Referred Patients Data Support
Meaningful accountability requires performance measures that accurately reflect the responsibilities of OPOs. Oversight should focus on factors within an OPO's control and influence, enabling better decision-making, clearer accountability, stronger system coordination, and greater public trust.
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: 5602
Dear Partnership for Quality Measurement (PQM) Team:
I appreciate the opportunity to provide comments on CBE ID: 5602 Rate of Referred Patients that are Approached for an Organ Donation in the Organ Procurement Organization’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.
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.
Comments in Support of the AOPO Performance Measurement Proposal
I appreciate the opportunity to comment on CBE ID: 5602, Rate of Referred Patients that are Approached for Organ Donation in the Organ Procurement Organization's Donation Service Area in a Calendar Year (Approach Rate), currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
The opportunity for organ donation begins when a hospital refers a potential donor to its designated Organ Procurement Organization (OPO). From that point, the OPO is responsible for evaluating the referral and guiding the donation process forward. One of the most important responsibilities during that process is having a compassionate conversation with a potential donor's family.
OPOs employ specially trained professionals who approach families with empathy, respect, and cultural sensitivity. These conversations give families the information, support, and time they need to make an informed decision about organ donation. Without an approach conversation, authorization cannot occur, making it one of the most critical steps in the donation process.
Because of that, Approach Rate is an important performance measure. It evaluates whether OPOs are consistently carrying out one of their core responsibilities. Lower approach rates can highlight opportunities to improve processes or remove barriers, while higher rates can help identify successful practices that can be shared across the donation community.
Today, CMS primarily evaluates OPO performance using donation and transplant rates. While those outcomes are important, they don't fully capture the work OPOs are responsible for. Transplant rates are influenced by many factors outside an OPO's control, including transplant center performance, organ allocation, and transportation logistics. As a result, transplant rate alone is not a precise measure of OPO performance.
The current CMS methodology also creates a forced ranking system where OPOs are measured against one another rather than against an objective standard. That approach is unique among Medicare programs and creates unnecessary instability in a system where consistency and collaboration are essential. When organizations face decertification based on relative rankings instead of clearly defined performance expectations, the focus shifts away from continuous improvement and toward surviving the ranking system.
If we want meaningful accountability, we need measures that evaluate organizations based on the work they actually perform. Good performance measures should provide actionable insights, strengthen collaboration, improve transparency, and build public confidence in the organ donation system.
Approach Rate does exactly that. It measures a fundamental responsibility of every OPO and provides valuable information that can be used to improve performance and increase donation opportunities.
The measure is built on a strong scientific foundation, follows CMS-aligned methodologies, and has been independently validated in partnership with Econometrica. That gives confidence that it is objective, reliable, and practical to implement.
Endorsing this measure will help OPOs identify opportunities to improve family approach practices, strengthen performance, and maximize the lifesaving potential of organ donation. Just as importantly, it creates accountability around work that OPOs directly control while supporting a more stable and effective national donation system.
Thank you for the opportunity to provide comments and for your consideration of this important measure.
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 5603: Authorization Rate for Organ Donation
Thank you for the opportunity to submit Public Comment. See attached letter.
LifeGift
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.
5602 Public Comment
Public comment from NFH regarding measure 5602 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: 5602 Rate of Referred Patients that are Approached for an Organ Donation in the Organ Procurement Organization’s Donation Service Area in a Calendar Year (Approach Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
The opportunity for organ donation is limited and begins when a donor hospital contacts the Organ Procurement Organization (OPO) after identifying a potential donor. Following this referral, the OPO is responsible for promptly evaluating the case and advancing the donation process. OPOs employ highly trained professionals who engage with potential donor families in a respectful, compassionate, and culturally sensitive manner. During these approach conversations, families are provided with the information, support, and time necessary to make an informed decision about donation. An approach conversation is a prerequisite for authorization and a critical step in increasing the number of organs available for transplantation. The Approach Rate serves as a meaningful metric for evaluating how consistently these conversations are occurring. Lower Approach Rates may signal opportunities to examine root causes and improve processes, while higher rates can help identify and reinforce effective practices.
As such, the Approach Rate is a critical performance metric for OPOs. It reflects a core operational function and plays a vital role in improving donation outcomes and saving lives.
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
Obtaining authorization for organ donation requires thoughtful, nuanced conversations that are influenced by many factors, including emotional readiness, timing, trust, communication, knowledge, and social and cultural considerations. CMS appropriately requires that these critical discussions be conducted by trained, designated requestors. Organ Procurement Organizations (OPOs) are responsible for ensuring that approaches to a potential donor patient’s next-of-kin are carried out with the utmost respect, sensitivity, and professionalism. Evidence consistently shows that authorization rates are higher when donation conversations are led by trained donation professionals who are equipped to guide families through complex decisions in a compassionate and informed manner. Strengthening this process can ultimately increase the number of organs available for transplantation.
The proposed Authorization Rate measure will provide OPOs with meaningful insight into the effectiveness of their approach conversations by quantifying authorization outcomes. This metric will enable OPOs to identify opportunities for improvement, enhance communication practices, and strengthen processes that support families in making informed decisions about donation.
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: 5602 Rate of Referred Patients that are Approached for an Organ Donation in the Organ Procurement Organization’s Donation Service Area in a Calendar Year (Approach Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
The opportunity for organ donation is limited and begins when a donor hospital contacts the Organ Procurement Organization (OPO) after identifying a potential donor. Following this referral, the OPO is responsible for promptly evaluating the case and advancing the donation process. OPOs employ highly trained professionals who engage with potential donor families in a respectful, compassionate, and culturally sensitive manner. During these approach conversations, families are provided with the information, support, and time necessary to make an informed decision about donation. An approach conversation is a prerequisite for authorization and a critical step in increasing the number of organs available for transplantation. The Approach Rate serves as a meaningful metric for evaluating how consistently these conversations are occurring. Lower Approach Rates may signal opportunities to examine root causes and improve processes, while higher rates can help identify and reinforce effective practices.
As such, the Approach Rate is a critical performance metric for OPOs. It reflects a core operational function and plays a vital role in improving donation outcomes and saving lives.
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.
In Support of Rate of Referred Patients Approached Measure
I appreciate the opportunity to provide comments on CBE ID: 5602 Rate of Referred Patients that are Approached for an Organ Donation in the Organ Procurement Organization’s Donation Service Area in a Calendar Year (Approach Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
The opportunity for organ donation is limited and begins when a donor hospital contacts the Organ Procurement Organization (OPO) after identifying a potential donor. Following this referral, the OPO is responsible for promptly evaluating the case and advancing the donation process. OPOs employ highly trained professionals who engage with potential donor families in a respectful, compassionate, and culturally sensitive manner. During these approach conversations, families are provided with the information, support, and time necessary to make an informed decision about donation. An approach conversation is a prerequisite for authorization and a critical step in increasing the number of organs available for transplantation. The Approach Rate serves as a meaningful metric for evaluating how consistently these conversations are occurring. Lower Approach Rates may signal opportunities to examine root causes and improve processes, while higher rates can help identify and reinforce effective practices.
As such, the Approach Rate is a critical performance metric for OPOs. It reflects a core operational function and plays a vital role in improving donation outcomes and saving lives.
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 comments on CBE ID: 5602 Rate of Referred Patients that are Approached for an Organ Donation in the Organ Procurement Organization’s Donation Service Area in a Calendar Year (Approach Rate) currently under review through the Partnership for Quality Measurement (PQM) endorsement process.
The opportunity for organ donation is limited and begins when a donor hospital contacts the Organ Procurement Organization (OPO) after identifying a potential donor. Following this referral, the OPO is responsible for promptly evaluating the case and advancing the donation process. OPOs employ highly trained professionals who engage with potential donor families in a respectful, compassionate, and culturally sensitive manner. During these approach conversations, families are provided with the information, support, and time necessary to make an informed decision about donation. An approach conversation is a prerequisite for authorization and a critical step in increasing the number of organs available for transplantation. The Approach Rate serves as a meaningful metric for evaluating how consistently these conversations are occurring. Lower Approach Rates may signal opportunities to examine root causes and improve processes, while higher rates can help identify and reinforce effective practices.
As such, the Approach Rate is a critical performance metric for OPOs. It reflects a core operational function and plays a vital role in improving donation outcomes and saving lives.
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.