Young Introduces Legislation to Bring Greater Accountability to Organ Donation System
WASHINGTON – Today, U.S. Senator Todd Young (R-Ind.) introduced legislation that aims to deliver more life-saving organs to patients by establishing clear, accountable metrics for organ procurement organizations (OPOs). Currently, the 58 OPOs in the United States maintain control over the organ procurement process, but questions surround the effectiveness, transparency, and accountability of these organizations.
“In Indiana there are more than 1,300 Hoosiers currently in need of a transplant, and nationally more than 113,000 people die annually waiting on an organ. After carefully studying this issue, it’s clear that the best way to save lives is to bring greater transparency, oversight, and accountability to the organizations responsible for getting organs from the donors to the patients who need them. This legislation will ensure that organ procurement organizations are no longer operating in darkness,” said Senator Young.
OPOs are the main link between donor hospitals and organ recipients, and their performance can be a limiting factor for all stakeholders in the organ donation system. In the last 20 years, no OPO has been decertified despite serious issues of underperformance. The recent decision by the Centers for Medicare and Medicaid Services (CMS) to recertify the New York City Organ Procurement Organization, LiveOnNY, despite persistent underperformance for nearly a decade, underscores the problem.
Senator Young’s legislation would require that OPOs be held to metrics that are objective, verifiable, and not subject to self-interpretation by OPOs so that there can be meaningful transparency, evaluation, and accountability for OPOs across the country. Currently, OPO performance is measured by data that is self-reported, unaudited, and fraught with errors.
The problem is best stated by the New York City OPO, who, in a letter to the Office of Management and Budget (OMB), stated that “the data that OPOs submit to CMS in connection with the outcome measures is self-reported and unaudited,” noting that “clearly, this type of ‘evidence’ fails to meet any reasonable definition of ‘empirical.’” Furthermore, the OPO trade association, the Association of Organ Procurement Organizations wrote to OMB that the “accuracy and consistency of [OPO] data cannot be assured.”
By updating OPO metrics, it will not only hold OPOs accountable to their performance, but will also allow for comparisons of OPO performance and geographic-level donation rates to identify areas in greatest need of interventions. This is desperately needed for the more than 113,000 Americans currently waiting for a lifesaving transplant.
In April 2019, Young wrote CMS Administrator Seema Verma urging CMS to replace the metrics by which OPOs are evaluated to meet the criteria of being objective and verifiable.
As first reported by the Washington Post, Young will be introducing a comprehensive series of bills aimed at reforming our organ donation system. This is the first in the series.
The legislation is supported by the American Society of Nephrology, Dialysis Patient Citizens, and ORGANize. Additionally, the following organizations have called for greater accountability in the OPO industry: American Association of Kidney Patients, American Society of Nephrology, Cholangiocarcinoma Foundation, Fatty Liver Foundation, Global Liver Institute, Liver Education Advocacy and Prevention Services, Renal Physicians Association.
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