A substantial change in how transplant centers are regulated

From the website of the American Society of Transplant Surgeons:  it appears (although the Final Rule is hard to parse) that reporting requirements including one-year graft survival numbers have been relaxed, which will change the way transplant centers are regulated...

CMS Removes Outcomes Requirement for Transplant Center Re-approval

Sep 27, 2019

ASTS applauds the Centers for Medicare and Medicaid Services for the elimination of outcomes requirements as a condition of transplant center re-approval.

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. “