The Transplant Eco-System: The Role of Data in CMS Oversight of The Organ Procurement Organizations
The Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) are federal agencies within the U.S. Department of Health and Human Services (HHS) that play important roles in protecting the health and safety of Americans as they engage with the U.S. healthcare system. The agencies share responsibility for overseeing the organ donation, procurement, and transplantation system. This is accomplished through CMS’ oversight of the Organ Procurement Organizations (OPOs) and transplant programs, along with HRSA’s oversight of the Organ Procurement and Transplantation Network (OPTN). As of December 2022, over 100,000 people were awaiting solid organ transplantation, and although there were 42,888 transplants performed in the U.S. in 2022, many available organs went unused[i].
A recent study demonstrated that the wait list will grow in future years as more people require organ transplants than can be transplanted.  The National Organ Transplant Act charges the OPTN to operate the national list of individuals needing organs and a national computer system to match organs with individuals on the waiting list. In March 2023, HRSA announced the OPTN Modernization Initiative to enhance system equity, accountability, and performance by modernizing OPTN technology, data transparency and analytics, governance, operations, and quality improvement and innovation.
In this blog, CMS outlines its strategy for OPOs. OPOs are non-profit organizations responsible for the procurement, distribution, and transplantation of human organs in a safe and equitable manner for all potential transplant recipients. They serve an essential role in supporting donor families, clinical management of organ donors, and professional and public education about organ donation. OPOs identify potential organ donors, request consent from the families of donors in the absence of a donor document, procure organs, work with other agencies to identify potential transplant recipients and ensure that organs are transferred to transplant hospitals.
There are currently 56 OPOs certified by CMS in the United States, each assigned to a donation service area (DSA). Recent publications have demonstrated the wide variability of organ retrieval by OPOs that contribute to disparities in the rate of transplants across these DSAs. These studies have found that if the rates of retrieval among OPOs were consistently high, many more successful organ transplants would occur throughout the U.S.
Requiring that the organizations responsible for organ procurement be transparent in their performance is vital to fostering improvements. In December 2020, CMS issued a final rule that updated the OPO Conditions for Coverage (CfCs) that OPOs must meet to receive Medicare and Medicaid payment. The December 2020 final rule revised the OPO CfCs to increase donation rates and organ transplantation rates by replacing the previous outcome measures. The new outcome measures improve on the prior measures by using objective, transparent, and reliable data, rather than OPO self-reported data, to establish the donor potential in the OPO’s DSA.
An OPO is designated for a 4-year exclusive agreement for each DSA, which is the duration of a recertification cycle. The December 2020 final rule established a tiering system whereby at the end of each 4-year recertification cycle, each OPO is ranked on its performance relative to the performance of other OPOs.
The current outcome measures permit CMS to review OPO performance every 12 months throughout the 4-year recertification cycle based on data for a calendar year time period. However, each 4-year recertification cycle has a single final assessment period, where the OPO is assessed for recertification purposes. The current recertification cycle began on August 1, 2022, and will end on July 31, 2026. CMS began evaluating OPOs utilizing the new measures in 2021, publicly posting the aggregated public performance report on CMS’ QCOR website in September 2021. The OPO performance reports are publicly posted each Spring. The 2023 OPO Public Performance report (link here) reflects the first full year of operations following the publication of the December 2020 CfC final rule using the new measures and tier status, reflecting OPO performance data from 2021. Posting these data is critical to holding OPOs accountable and serves as a crucial step in transparency and reforming the organ donation component of the overall transplantation system.
The new performance data reveals that many OPOs are currently in the lowest-performing tier (tier 3). Those in tier 3 are out of compliance with the established outcome measures, thus, not meeting the minimum standards to be an OPO. Tier 3 OPOs are the lowest performing OPOs that have one or both measures below the median and are subject to decertification. Decertified OPOs will not be able to compete for any other open DSA and will be replaced by a better performing OPO. While the first competition and potential decertification of OPO cannot begin until 2026, using data from 2024 or other sources, we will use our current oversight authority and public reporting to drive improvements immediately.
As we have learned with implementing many of Medicare’s quality programs, we believe that providing the performance reports between recertification cycles allows for focused improvements before further regulatory action is taken in 2026. We expect these low-tiered OPOs to focus urgently on making improvements.
CMS will continue to work with our partners at HRSA to align federal efforts, disseminate best practices, and provide low-performing OPOs with technical assistance to meet the established requirements. Our goal is for every OPO to meet minimum health and safety standards that must be met by providers and suppliers participating in the Medicare and Medicaid programs.
CMS and HRSA remain committed to increasing OPO performance in the organ transplantation system. Through the agency’s actions, CMS has taken another step towards improving this system by providing the most recent data on OPO performance to drive improvement for all 56 OPOs in order to meet the growing need for these lifesaving organs.
1. Spardy, J., et al., National Analysis of Recent Trends in Organ Donation and Transplantation in the United States: Toward Optimizing Care Delivery and Patient Outcomes. Am Surg, 2022: p. 31348221135776.
2. Marklin, G.F., D. Brockmeier, and K. Spector, The 20-year paradigm shift toward organ recovery centers: 2500 donors at Mid-America Transplant and broader adoption across the United States. Am J Transplant, 2023.
Fact Sheet: Organ Procurement Organization (OPO) Conditions for Coverage Final Rule: Revisions to Outcome Measures for OPOs CMS-3380-F: https://www.cms.gov/newsroom/fact-sheets/organ-procurement-organization-opo-conditions-coverage-final-rule-revisions-outcome-measures-opos
HRSA’s Organ Procurement and Transplantation Network Modernization Initiative: https://www.hrsa.gov/organ-procurement-transplantation-modernization