CMS Finalizes Changes to Organ Procurement Organization Conditions for Coverage

The Centers for Medicare & Medicaid Services (CMS) released a final rule modifying federal oversight of organ procurement organizations (OPOs) through changes and clarifications to the conditions of coverage. However, the final rule will not change the current three-tier structure used for OPO recertification and decertification. The CMS uses this structure to rank OPOs based on performance, incorporating the number of donors and number of organs transplanted into the score. Tier 1 OPOs perform at a level that is most risk adverse, meaning highest performing, whereas Tier 2 OPOs are moderately risk adverse, and Tier 3 are least risk adverse, meaning the lowest performing. 

The final rule, which goes into effect Jan. 4, 2027, will allow the CMS to begin working towards decertifying underperforming OPOs in Tier 3 donation service areas and includes improvements to revise the appeals process for OPOs facing decertification. The CMS further highlights four instances where the agency may terminate an OPO agreement involuntarily and clarifies that Tier 2 status alone is not a basis for decertification, allowing for greater turnover of OPOs in poor performance areas. Additionally, the rule finalizes a definition of “unsound medical practices” as failures by OPOs that create an imminent threat to patient health and safety or pose a risk to patients or the public. OPOs may be immediately decertified in case of an urgent need such as unsound medical practices.