Public discourse and policy change: Absence of harm from increased oversight and transparency in OPO performance

Abstract

The Centers for Medicare and Medicaid Services announced changes to the Final Rule for organ procurement organizations (OPOs) in November 2020, after a 23‐month period of public debate. One concern among transplant stakeholders was that public focus on OPO underperformance would harm deceased donation. Using CDC‐WONDER data, we studied whether donation performance dropped during the era of public debate about OPO reform (December 2018–February 2020). Overall OPO performance as measured relative to cause, age, and location‐consistent deaths rose by 12.3% in 2019, compared to a median annual change of 2.5% 2009–2019. Organ recoveries exceeded seasonally adjusted forecasts by 4.2% in the first half of 2019, by 8.1% following the Executive Order issuing a mandate for OPO metric reform, and by 14.1% between the Notice of Public Rule Making and the onset of COVID‐19‐related systemic disruptions. We describe changes in donor phenotype in the period of increased performance; improvement was greatest for older and donation after cardiac death (DCD) donors, and among decedents who did not have a drug‐related mechanism of death. In summary, performance during an era of intense public debate and proposed regulatory changes yielded 692 additional donors over expectations, and no detriment to organ donation was observed.

Opportunity to increase deceased donation for United States veterans

“…differences in OPO phenotypes with regard to recovery of donors from older and minority populations. [5][6][7] These findings suggest that optimizing donation can be considered as access to donation for decedents from different demographics. In this approach, maximizing donation is doubly beneficial, as it not only yields more organs for transplant but also minimizes disparities in the provision of federally mandated care and ensures that patients and families from all demographic groups can derive the emotional and psychological benefit of donation.…”

“…While recent regulatory reforms have established objective means to assess OPO performance, pathways by which to meet these targets are still being investigated 4 . Published data indicate differences in OPO phenotypes with regard to recovery of donors from older and minority populations 5–7 …”

Procurement characteristics of high- and low-performing OPOs as seen in OPTN/SRTR data

“…OPOs recovering significantly fewer donors and transplantable organs per CALC death than their peers will incur regulatory penalties, including potential decertification. Despite initial concern from some industry stakeholders, regulatory change has been welcomed as beneficial by government and patient advocacy groups and many OPOs, 3‐5 and donation performance has improved during this period of heightened public scrutiny 6 …”

Potential donor characteristics and decisions made by organ procurement organization staff: Results of a discrete choice experiment

“…The Centers for Medicare and Medicaid Services, a regulatory body overseeing OPO performance, has recently highlighted the need for quality improvement initiatives to increase the number of organs available for transplant 12 . Given the current discourse around variation in procurement practices, it is important to understand the role of OPO‐level evaluation of potential donors in an expansion of the deceased donor pool 13 …”

“…12 Given the current discourse around variation in procurement practices, it is important to understand the role of OPO-level evaluation of potential donors in an expansion of the deceased donor pool. 13 Previous research on the characteristics of deceased potential donors has shown that characteristics, such as age, type of death (brain death vs. cardiac death), and blood type, are associated with organ yield, while other characteristics including race and ethnicity are not. 10,14,15 However, it is unclear how such characteristics relate to the referral triage process at OPOs.…”