Patients are dying unnecessarily from organ donation policy failures

As former staffers who served Presidents Obama and Trump working on organ donation policy, we feel the need to correct the record about recent misinformation related to critical reforms of organ procurement organizations (OPOs).

When it comes to public policy, we often disagree. However, we absolutely agree on the urgent need for OPO reform, especially given the added risks from COVID-19 to patients with organ failure. 

Here are the facts: 33 Americans die every day for lack of a lifesaving organ transplant. The key to helping more of the 110,000+ patients on the organ waiting list is ensuring that government contractors on the frontline of organ donation (OPOs) are honoring potential donor wishes. Research suggests that 28,000 organs go unrecovered each year.

At the same time — no OPO has ever lost a contract due to underperformance. Zero. This despite data showing most OPOs are severely underperforming and recent reporting describing that “a startling number of life-saving organs are lost or delayed after being shipped.”

In an effort to protect vulnerable patients’ interests and institute basic accountability, CMS proposed new regulations in December 2019. Once finalized, these regulations will allow CMS to hold OPOs accountable based on objective data the government already has.

The Association of Organ Procurement Organizations (AOPO) has fought these regulations, often with misinformation that has had to be corrected by patient advocacy groups such as the Global Liver Institute.

Most recently, in an op-ed in The Hill, Dr. David Mulligan raised many AOPO points that are not grounded in the proposed reforms. Before addressing these points, we note that Mulligan is the President of the United Network of Organ Sharing (UNOS) — a government contractor currently the subject of bipartisan oversight by the Senate Finance Committee for failure to oversee OPOs — and a member of the Clinical Advisory Board of one of the OPOs that CMS flagged as failing basic proposed outcome measures.

First, it is wildly misleading for the op-ed to suggest “up to 75 percent of [OPOs]… could face decertification.” The proposed regulation establishes a benchmark, based on performance from the top 25 percent of OPOs, within which the rest of the OPOs must perform within a statistical degree of significance. The goal is to address massive, unexplainable variability across OPOs, which can be as large as 400%, and the expectation is that establishing such standards will lead all OPOs to sufficiently improve in order to maintain their contracts. It is entirely possible that OPO performance improves and none are decertified in any given evaluation cycle.  

The assertion that CMS has “no backup plan” for decertifications is also false. CMS stated in its proposed rule that, “Our goal is to ensure continuous coverage of an OPO service area in the event an OPO is decertified” with higher-performing OPOs taking over. There were originally 128 OPOs, and successful historical consolidations have brought that number down to the current 58. Never was this process disruptive. 

It is not true that CMS’ plan is “predicated on inaccurate data.” It is the current reporting standards that are inaccurate – and therefore unenforceable. We note the support for the proposed CMS metric in a peer-reviewed piece in the Journal of American Medical Association (JAMA) co-authored by the former U.S. Chief Data Scientist. 

The op-ed also objects to the CMS proposal to “hold OPOs accountable for instances in which suitable organs are not used for transplant.” But consider recent investigative reporting that highlighted that multiple times each month, organs are so damaged in transit that they have to be thrown in the trash. Is the suggestion that those organs should count as success? 

The defense of the U.S. donation system as the best in the world misunderstands the drivers of that performance. America has world-leading surgeons who are at the forefront of scientific innovation, pioneering medically-complex transplants. As for the recently increased organ recovery by OPOs, peer-reviewed research has found “it is indisputable that nationally the increased number of donors is almost wholly attributable to the drug epidemic, and reflects the byproduct of a national tragedy, rather than an improved system to be celebrated.” 

Critically, Mulligan offers no alternative to CMS’ proposal. Instead, he suggests “innovation, moving like clockwork, employing the latest technologies.” It is difficult to know what that means, and even more challenging to take his suggestion seriously given UNOS’ role in losing organs in transit, which Kaiser Health News found is due to UNOS’s reliance on “a primitive system of phone calls and paper manifests, with no GPS or other electronic tracking required.” (Note: this UNOS failure is a point of the investigation by the Senate Finance Committee and oversight from Reps. Katie Porter and Karen Bass.)

We are writing because there is an active campaign to obscure a fundamental issue: patients are dying unnecessarily and the federal government is trying to hold its contractors accountable. 

In 2020, with so many policy issues splitting Congressional offices – and the country – this one is both clear and fixable. It has bipartisan support from Congressional leaders ranging from the President of the Congressional Black Caucus to members of the Tea Party, and both Co-Chairs of the House Kidney Caucus.

CMS should finalize the rule at the standard proposed as soon as possible. Lives are lost every day that goes by.

Jennifer Erickson is a Schmidt Futures Innovation Fellow and served at the White House under President Obama from 2015 – 2017. Erickson’s work has been supported by Arnold Ventures. Abe Sutton served at the White House under President Trump from 2017 – 2019. Both worked on organ donation policy.