On January 28th, CMS proposed revisions to Organ Procurement Organizations’ (OPOs) conditions for coverage that the Agency hopes will strengthen federal oversight and improve access to high quality organs for patients. If adopted, the regulation would:  

  • Exclude pancreata used for islet cell research for the Transportation Rate Outcome Measures and add recordkeeping requirements “to ensure research organs are used in bona fide islet cell research.” 
  • Require that OPOs assess their performance in placement of organs from medically-complex donors, like organs donated by older donors. 
  • Explicitly define “unsound medical practices” as failures by OPOs that create “an imminent threat to patient health and safety,” pose a risk to patients, or endangers the public in other ways. 
  • Clarify that OPOs with Tier 2 agreements compete to be recertified or face eventual decertification. This would be after a multi-year process, click here to jump to the proposed regulatory text. 
  • Remove previous requirements limiting certification of OPOs recertified between 2002 and 2005, opening up certification of new OPOs. 

 

CMS will accept comments on the proposed rule through March 31, 2026.