HHS Seeking Comments on Organ Procurement Proposed Rule

The U.S. Department of Health and Human Services (HHS) today took major steps to increase the availability of organs for the 113,000 Americans on waitlists for lifesaving organ transplants – 20 of whom die each day. As directed by President Trump in his July 10 Executive Order on Advancing American Kidney Health, the Centers for Medicare & Medicaid Services (CMS) is issuing a proposed rule to change the way organ procurement organizations (OPOs) are held accountable for their performance, and the Health Resources and Services Administration (HRSA) is issuing a proposed rule to remove financial barriers to organ donation.

“Our broken system of procuring organs and supporting kidney donors’ costs thousands of American lives each year,” said HHS Secretary Alex Azar. “President Trump sees kidney disease as a health challenge where we can make a major impact, and his Advancing American Kidney Health initiative, including today’s announcements, will transform the lives of American kidney patients, who have been neglected for too long. Many organ procurement organizations do wonderful work, but some aren’t performing nearly as well as they could. We’re going to stop looking the other way while lives are lost and hold OPOs accountable. On living donations, we’re going to dramatically expand support for living kidney donors, so that Americans who wish to be generous living donors don’t face unnecessary financial barriers to doing so.”

The Trump administration is dedicated to addressing the inefficiencies in our organ procurement system and increasing the number of organs available for transplant to reduce the number of individuals waiting for lifesaving transplants.

Most of the proposed changes would not take effect until 2022. However CMS intends, in the spirit of transparency, to make these outcome measures public during the next four-year OPO recertification cycles once the rule is finalized.

Comments on both proposed rules are due 60 days after the rules’ publication in the Federal Register.

To read the full press release on today’s announcement as well as access fact sheets and the proposed regulations, visit: