Overview
- CMS unveiled a 197-page proposal to tighten oversight of organ procurement organizations and expand use of organs from older or sicker donors by formalizing the category of medically complex organs.
- The rule would define unsound medical practices, expand reportable adverse events, and require tracking of the procurement and placement of medically complex organs.
- Oversight would become more targeted, with region-by-region performance reviews, the option to replace OPOs in underperforming areas, and removal of a barrier to certifying new organizations.
- CMS Administrator Dr. Mehmet Oz said the plan strengthens accountability and provides tools to remove underperformers, with public comments due by March 31 and final action expected later this year.
- The proposal follows a rare decline in deceased donations and shaken public confidence after halted retrievals when patients showed signs of life, as OPO leaders express cautious optimism and call for hospital and transplant center support.