The announcement was part of the Omnibus Burden Reduction (Conditions of Participation) Final Rule, which will be published in the Federal Register on September 30, and the outcomes requirements are included in the data submission requirements being eliminated.
In announcing the Final Rule, CMS stated, “In an effort to improve patient care, CMS is responding to President Trump’s Executive Order on improving kidney health in America by strengthening the organ donation process. Specifically, the rule finalizes changes to transplant center requirements giving providers greater flexibility and freedom to support patients who need organ transplants. Current Medicare transplant center regulations for re-approval are burdensome. They are so burdensome, in fact, that they have led to some transplant programs avoiding performing transplants for certain patients, causing some organs to be discarded. The Omnibus rule will eliminate these requirements – specifically for data submission – which will reduce the number of organs that are discarded and increase the number of organs that are available for transplantation. As a result, more patients on the transplant waiting list will have access to lifesaving organ transplants. “
ASTS has been working with CMS for over 3 years, submitting comments on various rules and taking every opportunity to request that these outcomes requirements be eliminated, since they are duplicative of OPTN oversight of transplant centers. Thank you to all the ASTS members who have been involved, including those on the Council, Regulatory Relief Task Force, and ASTS/AST Joint Metrics Task Force.