The $16.5 Million Medicare Spent to Say No
CMS published a 55-page final rule this morning rewriting how organ procurement organizations are designated, competed and de-certified, and used it to tell 54 of them that the performance cycle which just closed is final. The rule costs $16.5 million in year one against $598,000 in annual benefits by CMS's own count. Also in the window: the fee schedule's statutory deadline passed on Sunday with all three rate books still inside OMB, and the psych unit attestation that decides your payment system is up for reinstatement.
In 2019 an executive order told the Secretary to build "transparent, reliable, and enforceable metrics" for judging organ procurement organizations.
CMS answered in December 2020 with a rule that replaced self-reported performance with two volume measures and a three-tier structure, and set the first assessment cycle running from 2022 through 2026.
That cycle is now closed. The organizations that failed it spent the comment period asking CMS to wait.
"What does a regulator do with 55 pages of clarifications when the thing being clarified has already happened?"
What Landed This Morning
CMS-3409-F published at 91 FR 69390 today, 55 Federal Register pages, effective January 4, 2027. It finalizes the January 2026 proposal at 91 FR 4190.
The rule rewrites real machinery. Definitions, the designation framework for an organization holding more than one donation service area, when a service area is open for competition, how actions against an OPO agreement get categorized, the appeal process, staff licensure, records for organs procured for research, and new QAPI duties around medically complex donors.
It also kills the leftover requirement that an organization have been re-certified between 2002 and 2005 to be eligible at all.
What it does not touch is the part everyone wrote in about. CMS says flatly that the rule "does not revise the focus on improving the volume of donors and transplants assessed in the outcome measures or the tier structure used for re-certification and de-certification of OPOs."
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