New Requirements for Organ Procurement Organizations


Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations will take effect March 30, 2021

Last November, the U.S. Department of Health and Human Services (HHS) acted, as advocated for by ASN, to increase organ donation rates and transplantation rates, applying new standards of accountability and transparency to the nation’s Organ Procurement Organizations (OPOs).  HHS did this by finalizing  a rule that imposes new transparency requirements for the nation’s 58 OPOs to receive payment from Medicare and Medicaid. Approximately 113,000 Americans are on transplant waiting lists.

This rule is considered important for improving transplant equity. Black Americans are half as likely to receive a kidney transplant as White Americans, and similar disparities exist for other patients of color. The causes of this disparity are multifactorial, but factors within the control of OPOs contribute to this gap.However, when OPOs follow protocol, donor authorizations from families of color rapidly increase.  The rule will enable the government to better hold OPOs accountable for how they treat donors of color, increasing the number of organs available for transplant and reducing the racial disparity in transplantation.

In a routine step by a new administration, President Joe Biden’s chief of staff, Ronald A. Klain, issued a January 20 memo that ordered that all rules, guidance, or other agency actions—that did not take effect prior to noon that day—be subject to review by the new administration before they can be implemented. Thus the OPO rule will now take effect March 30, 2021 instead of February 1. The Biden administration is also providing a 30-day public comment period.

“As I said last November and restate today, this final rule will enable us to better evaluate and ultimately improve our organ recovery processes, allowing thousands more patients a year to receive a kidney transplant.  I hope this review is completed in a timely fashion,” said transplant nephrologist Barbara Murphy, MB BAO BCh, FRCPI, Mount Sinai Health System department of medicine chair and a councilor for the American Society of Nephrology.

ASN reported last November that as many as 28,000 more organs per year could be transplanted as a result of these improvements.  A paper by the Bridgespan Group, Reforming Organ Donation in America,2 projects a “potential to recover up to 28,000 more organs from deceased donors per year, saving thousands of lives and billions in taxpayer funds from the avoided costs of dialysis and increased productivity.”  That translates into an estimated 17,000 kidneys; almost 8,000 livers; 1,500 hearts; and 1,500 lungs.

 An analysis by Bloom Work Digital3 reported “Each of the 58 OPOs in the U.S. operate without competition from any other organizations in their respective regions, effectively making them monopolies. In addition, there is no standard way that OPOs operate. This leads to a wide variance of performance — up to a 470% difference between the best and worst OPOs in terms of potential organs recovered."4

ASN supports this final rule and all efforts to establish standardized national metrics to assess OPO performance and provide pathways for improvement and will continue to advocate for its implementation under the Biden administration.