CMS Proposes Revisions to Organ Procurement Organization Conditions for Coverage
- January 30, 2026
The Centers for Medicare & Medicaid Services (CMS) proposed January 28 new rules for organ procurement organizations (OPOs) including maximizing the use of medically complex organs, which usually come from older or sicker donors.
The move is part of a broader effort to overhaul and step up oversight of the nation’s organ transplant system.
OPOs are federally designated nonprofits tasked with coordinating the recovery of organs for transplantation in specific geographic regions of the United States.
The proposed rule, which was published in the January 30 Federal Register (91 Fed. Reg. 4190), would revise Conditions of Coverage for OPOs to strengthen federal oversight, improve the framework for upcoming re-certification cycles, and “increase the number of viable organs that reach patients in need,” a fact sheet said.
CMS published the Conditions of Coverage rule in December 2020 with reforms that the agency said have significantly improved OPO performance, including a 31% uptick in organ donors and a 25% increase in organ transplants over four years.
The proposed rule would add new definitions, including for “unsound medical practices” that can trigger decertification of OPOs. Under the proposal, CMS would define 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,” the fact sheet said.
CMS also is proposing to add a definition of “medically complex donor” as part of another revision aimed at assisting OPOs in “facilitating appropriate placement and utilization of these organs to increase the pool of organs available for transplantation.”
Other proposals include removing regulatory limits that prevented certification of new OPOs.
CMS is asking for public comments on a process for certifying new OPOs; addressing conflicts of interest in organ and tissue procurement; automated electronic referrals from donor hospitals to OPOs; and alternative approaches to OPO designation to more than one service area and non-renewal of OPO agreements.
Comments are due March 31.