Bipartisan reform of organ procurement organizations (OPOs) will save lives

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Responses to misleading claims from the Association of Organ Procurement Organizations (AOPO)

Summary: HHS has proposed OPO reforms that will help thousands more patients access organ transplants. Misleading claims should not stop this lifesaving, bipartisan effort. Answers to new AOPO points below. The Global Liver Institute has highlighted previous misleading claims. Former HHS Chief Technology Officer Bryan Sivak called OPOs “some of the most obstructionist stakeholders I’ve ever come across. When OPOs fail, patients die.”

AOPO: “Under the proposed rule, the bar to “pass” CMS certification is arbitrarily set at the top 25th percentile thereby ensuring that 75% of OPOs – including those that perform among the world’s best – will fail to meet the metrics.” 

Response: The cut off does not come into effect unless there is a statistically significant difference between those below and above it, and is HHS’ response to drastic, unexplained (up to 400%) variation in OPO performance. Numerous studies show OPOs recover a fraction of available donors (e.g., HRSA’s Study, U Penn study published in American Journal of Transplantation, and investigative reporting from the Washington Post and the Associated Press). Bringing underperforming OPOs into compliance with HHS’ proposed standards would mean another 5,000+ organs transplanted each year.

AOPO: “Moving forward with this action would destabilize the donation and transplantation system without an identified path for OPO performance improvement potentially leading to loss of lives.” 

Response: There were originally 128 OPOs; now there are 58, with no data suggesting that these consolidations were disruptive. The health sector is able to handle transitions. As the status quo is costing patients’ lives – with 28,000 organs going unrecovered each year – transitions are long overdue. AOPO concedes the current metric is fraught with problems. DJ Patil, former Chief Data Scientist of the United States, in JAMA: “The current metric is unenforceable and thereby fails a basic public trust, ensuring that no OPO can ever be held truly accountable, no matter how many people die on the waiting list.” No OPO has lost a contract in decades and OPOs are lobbying to stall reforms. Baylor College of Medicine: “only the best performing OPOs should be surviving, while those underperforming centers are subject to consolidation or closure.”

AOPO: “Death certificates include the primary cause of death and inconsistently document secondary conditions such as if the deceased individual was COVID-19 positive or had metastatic cancer and therefore medically ineligible for donation.”

Response: Almost all errors in death certificate data pertain to the chain of events leading to death, not the final cause, so do not impact the ultimate determination as to whether the donor was viable for transplant. In fact, 92% of all causes of donor death are asphyxiation, blunt injury, drug intoxication, gunshot wounds, drowning, stroke, or cardiovascular causes, which is obvious to diagnose. AOPO’s invoking of “death certificate errors” is a red herring.

AOPO: “As both proposed metrics share the same data source as a denominator, i.e. donor potential based on death certificates, not only are they both calculated from a faulty data set, they are also statistically highly correlated. In essence, both proposed metrics measure the same thing….”

Response: HHS noted the rationale for these two metrics in the NPRM (pgs 16-17), which measure two distinct functions of OPOs: the ability to recover organs from a sufficient percentage of potential donors, and the ability to clinically manage the donors through the donation process in order to recover more organs from each donor. There has been extensive reporting about OPO failures on the former. For the latter, OPOs themselves have admitted to “gaming the process of meeting the [current standards]  by only targeting “high-yield” organ candidates” and are “incentivized to not pursue, or even evaluate the potential for donation of these types of [low-yield] donors. This practice results in fewer organs being transplanted, and more lives lost.” The new proposed rule addressed both of these key concerns using two distinct metrics.

Washington Post ed board: “in a system in which these nonprofits have an effective monopoly on organ recovery within their zones, there are few incentives for them to improve unless decertification is a serious possibility. The Trump administration should stick with its original instincts and finalize the rule, as soon as possible.”