CMS proposes new rule to boost transplant outcomes

To enhance patient organ transplant safety and minimize missed donations, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule to improve federal oversight of Organ Procurement Organizations (OPOs).

According to CMS, the standards for organ recovery and transplantation, and the regulations for OPO re-certification are clearer.

What to know about the proposed rule:

• Enhanced performance measures and tighter documentation: Exclude pancreata used for islet cell research for the transplantation rate outcome measure and add recordkeeping requirements to ensure research organs are used in bona fide islet cell research.
• Defines and deters unsafe practices: Codify a clear definition of “unsound medical practices,” expand examples of reportable adverse events, and strengthen quality-improvement expectations so serious governance, safety, or organ-handling failures can be identified and addressed quickly.
• Maximizes use of medically complex organs: Requires OPOs to assess their performance in placement of organs from medically complex donors (e.g., older donors or donors with less-than-optimal health status) and takes actions to improve such performance when possible, expanding opportunities for life-saving matches.
• Increases accountability and smart competition: Builds on the comprehensive framework established in 2020 by holding underperforming organizations accountable and removing barriers that disincentivize higher performing OPOs from competing for failing areas.
• Removes a barrier to new OPO certification: Removes an outdated regulatory requirement limiting certification eligibility, paving the way for future certification of new OPOs. 

The proposed rule is open for public comment for 60 days following publication in the Federal Register. Comments can be submitted at: federalregister.gov/public-inspection/2026-01833/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to.