November 20, 2020

HHS Finalizes Rule Modeled After Young’s Organ Donation Legislation

WASHINGTON – The U.S. Department of Health and Human Services (HHS) today announced it has finalized a proposed rule modeled after legislation introduced by Senator Young to bring greater accountability to the nation’s organ donation system and deliver more lifesaving organs to patients.


“Saving lives must be the number one priority for organ procurement organizations, which are responsible for getting donated organs to patients in need. Unfortunately, we have seen that this is not always the case. HHS’ new rule, which is modeled after my legislation, will finally ensure that these organizations are held accountable and subject to metrics that are clear and verifiable,” said Senator Young. “The nearly 109,000 Americans who are currently waiting on an organ transplant, including 1,124 Hoosiers, can rest a little easier knowing that this rule is going to result in more organs reaching the patients who need them.” 


Similar to Senator Young’s legislation, the new HHS rule would establish clear metrics to hold accountable organ procurement organizations (OPOs), the government contractors that maintain control over the organ procurement process. There are 58 OPOs in the United States and questions have been raised regarding the effectiveness, transparency, and accountability of these organizations. Inspector general audits and news reports have raised questions about the adequacy of patient safety standards, suggested thousands of available organs are not being used, and highlighted questionable financial practices of some OPOs


These failures are not for a lack of resources, as the OPO industry receives $3 billion annually from taxpayers for which there are almost no financial controls or pressures for cost containment. Tax filings indicate that OPO executives’ annual compensation can exceed $2.5 million, with investigative reporting detailing abuses from self-dealing to OPOs spending taxpayer dollars on private planes and golf tournaments.


Despite the vital importance of OPOs in the organ donation process and the questions surrounding their conduct and effectiveness, HHS does not currently have any meaningful way to regulate them. OPO performance is measured by data that, by their own admission, is self-reported, unaudited, and fraught with errors, which has allowed underperformance to persist for decades. The new rule will establish metrics that are objective, verifiable, and not subject to self-interpretation so that there can be meaningful transparency, evaluation, and accountability for OPOs across the country.


Senator Young has been working to reform the nation’s organ donation system dating back to his time in the U.S. House of Representatives when his friend, Marine Dave ‘Gunny’ McFarland from Jeffersonville, Indiana, died because his heart transplant never came. In July 2019, Senator Young introduced his legislation to bring greater oversight to OPOs and penned an op-ed outlining the need to act. In December 2019, HHS announced proposed rules to adopt performance measures similar to Senator Young’s bill. Senator Young also sent letter to the HHS Office of Inspector General and to HHS Secretary Alex Azar seeking a comprehensive examination of the adequacy of the organ procurement and transplantation system in the United States.