Increasing the U.S. Organ Supply: New Requirements for the Nation’s 58 Organ Procurement Organizations

By David White

November 20, 2020

 

Final rule applies new standards to organ procurement in the U.S.

The U.S. Department of Health and Human Services (HHS) today took action to increase donation rates and organ transplantation rates by applying new standards of accountability and transparency to the nation’s Organ Procurement Organizations (OPOs).  HHS finalized the Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization rule that was proposed earlier this year by the Centers for Medicare and Medicaid Services (CMS). 

What does the rule mean for you and your patients?

  • More patients may get transplants. The new regulation replaces current metrics with new transparent, reliable, and objective measures,  to help more patients access lifesaving organ transplants.
  • As many as 28,000 more organs per year.  A paper by the Bridgespan Group, Reforming Organ Donation in America1,  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. 
  • Monopolies and huge variances in performance will be reduced. An analysis by Bloom Work Digital2 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.3
  • Equity will Increase. 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.4  However, when OPOs follow protocol, donor authorizations from families of color rapidly increase.5  By establishing standardized national metrics to assess OPO performance and providing pathway for improvement, the government will 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. The final rule also avoided adjusting OPO performance for the race of the population they serve, a policy that ASN argued would have codified harmful disparities.
  • Processes will improve. There are a number of ways organs do not end up getting used.  Some are diagrammed here.

“Bringing a more data-driven, transparent approach to our nation’s organ procurement efforts is a crucial and overdue change that ASN has long championed,” 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. “Today’s 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.”

The final rule will implement two new performance evaluation metrics using the data from the Centers for Disease Control and Prevention Detailed Mortality File—replacing self-reported data and enabling the federal government and researchers to make meaningful comparisons across OPOs nationwide. Importantly, this approach will not require any new data reporting or administrative burden on the nation’s hospitals and healthcare systems.  OPOs that are not meeting performance expectations will have four years to improve their performance.

ASN will monitor the implementation of these policies to evaluate them for efficacy and any potential consequences.  For questions, please contact policy@asn-online.org.

 

1)  https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-01-2019.pdf

2)  https://bloomworks.digital/organdonationreform/Summary/

3)  https://www.govinfo.gov/content/pkg/FR-2019-12-23/pdf/2019-27418.pdf

 4) Siminoff, L A, Lawrence, R H, Arnold, R M. Comparison of black and white families' experiences and perceptions regarding organ donation requests. 2003, Crit Care Med. doi: 10.1097/00003246-200301000- 00023.

  5) Siminoff, L A, Shafer, T J. Public Comment Re CMS-3380-P: Proposed Rule on OPO Conditions of Coverage. February 18, 2020. Retrieved September 30, 2020

Category:
Subcategory:
Author:
David White
Body:

 

Final rule applies new standards to organ procurement in the U.S.

The U.S. Department of Health and Human Services (HHS) today took action to increase donation rates and organ transplantation rates by applying new standards of accountability and transparency to the nation’s Organ Procurement Organizations (OPOs).  HHS finalized the Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organization rule that was proposed earlier this year by the Centers for Medicare and Medicaid Services (CMS). 

What does the rule mean for you and your patients?

  • More patients may get transplants. The new regulation replaces current metrics with new transparent, reliable, and objective measures,  to help more patients access lifesaving organ transplants.
  • As many as 28,000 more organs per year.  A paper by the Bridgespan Group, Reforming Organ Donation in America1,  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. 
  • Monopolies and huge variances in performance will be reduced. An analysis by Bloom Work Digital2 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.3
  • Equity will Increase. 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.4  However, when OPOs follow protocol, donor authorizations from families of color rapidly increase.5  By establishing standardized national metrics to assess OPO performance and providing pathway for improvement, the government will 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. The final rule also avoided adjusting OPO performance for the race of the population they serve, a policy that ASN argued would have codified harmful disparities.
  • Processes will improve. There are a number of ways organs do not end up getting used.  Some are diagrammed here.

“Bringing a more data-driven, transparent approach to our nation’s organ procurement efforts is a crucial and overdue change that ASN has long championed,” 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. “Today’s 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.”

The final rule will implement two new performance evaluation metrics using the data from the Centers for Disease Control and Prevention Detailed Mortality File—replacing self-reported data and enabling the federal government and researchers to make meaningful comparisons across OPOs nationwide. Importantly, this approach will not require any new data reporting or administrative burden on the nation’s hospitals and healthcare systems.  OPOs that are not meeting performance expectations will have four years to improve their performance.

ASN will monitor the implementation of these policies to evaluate them for efficacy and any potential consequences.  For questions, please contact policy@asn-online.org.

 

1)  https://www.bridgespan.org/bridgespan/Images/articles/reforming-organ-donation-in-america/reforming-organ-donation-in-america-01-2019.pdf

2)  https://bloomworks.digital/organdonationreform/Summary/

3)  https://www.govinfo.gov/content/pkg/FR-2019-12-23/pdf/2019-27418.pdf

 4) Siminoff, L A, Lawrence, R H, Arnold, R M. Comparison of black and white families' experiences and perceptions regarding organ donation requests. 2003, Crit Care Med. doi: 10.1097/00003246-200301000- 00023.

  5) Siminoff, L A, Shafer, T J. Public Comment Re CMS-3380-P: Proposed Rule on OPO Conditions of Coverage. February 18, 2020. Retrieved September 30, 2020

Date:
Friday, November 20, 2020