CMS finalized a rule Oct. 30 that tightens federal oversight of organ procurement organizations, clarifying when the agency can decertify poor performers and allowing top-performing OPOs to compete for multiple donation service areas.
The agency first proposed the rule in January. The rule takes effect 60 days after its Nov. 3 Federal Register publication, and CMS estimates it will cost $16.5 million in the first year and $7.9 million annually after that.
It builds on CMS’ 2020 rule, which tied OPO certification to donation and transplant rates and opened low-performing service areas to competition. The nation’s 54 OPOs currently serve 55 donation service areas.
“Americans waiting for lifesaving transplants cannot afford poor performance by OPOs, and CMS is committed to holding these organizations accountable,” CMS Administrator Mehmet Oz, MD, said in a news release.
Here are seven notes:
- CMS can now decertify unsafe OPOs faster. The rule defines “unsound medical practices,” which clarifies when CMS can use its existing authority to immediately decertify a noncompliant OPO. It also lays out the circumstances under which CMS may decertify an organization.
- High performers can expand into new territory. Top-performing OPOs can compete for multiple donation service areas. Outgoing OPOs must cooperate with incoming ones, which must submit a transition plan and progress updates to keep donation operations running.
- Research pancreata no longer count as transplants. Pancreata procured only for islet cell research still count toward an OPO’s donation rate but not its transplantation rate unless transplanted. OPOs must also document what happens to every organ sent for research.
- Adverse event expectations are clearer. The rule offers OPOs firmer guidance on identifying, investigating and preventing adverse events.
- Appeals get an added layer of review. The rule codifies discretionary CMS administrator review of hearing officer decisions and updates appeal timelines. It also removes a decades-old provision limiting certification to OPOs recertified between 2002 and 2005.
- Medically complex organ provisions were cut. Commenters were split on the proposed definitions, so CMS dropped them and the related tracking requirements, saying it will watch for nationally accepted standards.
- Staff licensure and electronic referrals were deferred. Medical directors must be licensed in at least one state or territory the OPO serves, but CMS dropped broader staff licensure after warnings about workforce strain. Comments on automated hospital referrals may inform future rulemaking.
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