CMS proposed new steps to strengthen federal oversight of organ procurement organizations Jan. 28.
The 197-page proposed rule is part of a broader effort to modernize the nation’s organ transplant system, including recent governance reforms and CMS enforcement actions against underperforming OPOs.
“CMS will not tolerate unsafe practices or failures that put patients at risk and weaken trust in the system,” CMS Administrator Mehmet Oz, MD, said in a news release. “This proposed rule strengthens accountability, clarifies expectations, and gives us stronger tools to remove underperforming organizations, protect patients, and honor the incredible gift of life.”
The proposed changes aim to boost transparency and accountability across OPOs while increasing the number of viable organs available for transplant. More than 100,000 Americans are currently on the organ transplant waiting list, according to CMS.
Six things to know:
1. The proposed rule would revise and add key regulatory definitions that OPOs must meet to remain certified and eligible to operate within the Medicare transplant system. CMS is proposing formal definitions for “medically complex donors” and “unsound medical practices” to help clarify expectations and support faster identification of serious safety or governance issues.
2. The agency also proposed expanding the list of reportable adverse events and strengthening quality improvement expectations so serious organ-handling or governance failures can be identified and addressed more quickly.
3. CMS aims to maximize the use of medically complex organs. These organs often come from older donors or those with poor health. While historically underitilized, these organs can be succesfully transplanted when matched to the right recipient, CMS said. The proposal would require OPOs to track the procurement and placement of these organs as part of new quality reporting rules and act on improvement opportunities.
4. The agency is proposing a more targeted oversight approach for OPOs operating across multiple service areas. CMS would evaluate OPO performance region by region, allowing the agency to remove an organization from an underperforming area while preserving operations where performance standards are met. CMS also seeks to clarify when an OPO’s service area would be opened to competition, allowing higher-performing organizations to replace OPOs not meeting standards.
5. CMS wants to remove an outdated rule that has limited the certification of new organ procurement organizations for decades. The change would give the agency more flexibility to certify new OPOs, potentially increasing competition in underperforming service areas and reshaping how procurement regions are managed over time.
6. CMS is accepting public comment on the proposed rule through March 31. Specifically, the agency is seeking input on implementing automated electronic referral systems between donor hospitals and OPOs. The United Network for Organ Sharing applauded CMS’ support of automated electronic referrals and its effort to improve tracking of organs in transit — two key reforms the group has long championed.
“These are the kinds of significant improvements that patients deserve,” UNOS said in a Jan. 28 statement. “These bold, practical actions from CMS represent meaningful progress for patients, families, the organ donation and transplant community, and all Americans.”
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