On Friday, December 12, three Organ Procurement Organizations (OPO) joined in filing suit challenging the Centers for Medicare and Medicaid Services’ (CMS) Final Rule of November 2020 (Revisions to the Outcome Measure Requirements for Organ Procurement Organizations). The lawsuit asserts that CMS failed to adopt empirically based performance standards to assess OPOs for recertification based on their service areas as required by statute and instead adopted a competition-based recertification process, not sanctioned by law nor envisioned by Congress.
The CMS regulations, if allowed to stand, establish a system of competition for human organs. This self-described competitive scheme designed to make OPOs more aggressive is contrary to the framework Congress created when it passed the National Organ Transplant Act in 1984 providing for the formation, operation and evaluation of regional community-based, non-profit organ procurement organizations to recover organs safely and effectively from deceased donors within each designated service area.
The OPOs filing suit are New England Donor Services (Waltham, MA), Gift of Life Michigan (Ann Arbor, MI), and We Are Sharing Hope (Charleston, SC).
Backed by academic studies and independent research (noted in the filing), the lawsuit further asserts that the metrics used by CMS to measure OPO performance for competitive ranking are arbitrary and capricious, inaccurate and insufficient to determine actual OPO performance levels. While OPOs have long advocated for implementation of performance measures that accurately assess performance and drive performance improvement, the measures adopted by CMS in the regulations at issue in this lawsuit do neither. They will, instead, lead to large scale OPO decertifications and competition for service areas in over half the nation, resulting in disruption to the life-saving work of our national system of donation and transplant. All three OPOs achieved record numbers of organ donations in 2024 (the performance assessment year).
In the interest of protecting transplant patients and promoting donor safety, the OPOs have filed this action to prevent destabilization of the system with the goal of reformed and modernized metrics that comply with the National Organ Transplant Act’s specific requirements, accurately assess OPO performance using available technology, and drive safe improvement for donors and patients.