CMS issues final rule on oversight of organ procurement organizations

The Centers for Medicare & Medicaid Services Oct. 30 released a final rule updating conditions for coverage for organ procurement organizations. The final rule eliminates a regulatory requirement that limited the Secretary of Health and Human Services in certifying new OPOs; clarifies the OPO designation process, including requirements for OPOs operating in multiple donation service areas; modifies the appeals process for OPOs; and updates and adds certain key definitions, among other changes specific to OPOs.

While the final rule eliminated the requirement restricting new OPO certifications, it did not establish a process for certifying or designating new OPOs. CMS intends to address those processes in future rulemaking. The final rule will take effect on Jan. 2, 2027.