Bioethics Forum Essay
New Regulation for Organ Procurement Will Improve Equity and Save Lives
In the more than 35 years since federal legislation created organ procurement organizations (OPOs) to recover organs from deceased donors for transplantation, there has been a disparity in their performance, with the best OPOs recovering organs from four times as many donors as the worst OPOs by objective criteria. This unexplainable disparity is responsible for thousands of deaths each year in the United States, with disproportionate impact in communities of color.
Peer-reviewed research has documented deep racial inequities in the OPO industry, including that OPOs are only about half as likely to even respond to a donation referral involving a Black donor versus a white donor. And yet no OPO has ever been decertified for failure to procure organs, or a host of other documented problems. Performance metrics were subjective, gameable, and legally unenforceable.
Concerns about poor OPO performance led the Biden administration to implement a new OPO regulation in April, finalizing bipartisan reforms announced by the Trump administration, which also built on work launched in the Obama administration. These reforms are projected to save more than 7,000 lives every year, address inequitable health outcomes for patients of color, and save Medicare $1 billion annually in avoided dialysis costs. They have garnered support from a broad bipartisan Congressional coalition and “as diverse an expert group as any public health initiative in recent memory.” In the era of Covid-19, which is increasing demand for organs by creating a “completely new category” of patients who need organ transplants, the new regulations have only become more urgent.
The new regulation will evaluate OPOs based on objective, government data. While this may sound somewhat obvious and anticlimactic, this has never before been the case. OPOs will finally be held to objective performance metrics.
This is likely to significantly increase organ transplants and benefit communities of color, which suffer from disproportionately high rates of organ failure. Not only will this improve overall health and quality of life, but more transplants will also generate substantial savings for taxpayers. In particular, every kidney transplant saves Medicare more than $1 million in avoided dialysis costs. Increasing transplants by the thousands will save taxpayers billions of dollars.
Despite these benefits, the new regulation has come under criticism. For example, a recent piece by Brendan Parent and Alexander Cheung entitled “U.S. Organ Donation Needs Better Oversight, but New Rule Will Not Help” incorrectly argued that its use of death certificate data is unreliable because it can be subject to errors. This view represents a misunderstanding of how the new rule works.
The data source selected by the Centers for Medicare and Medicaid Services (CMS)–after an extensive review period–is not simply a compilation of death certificates; it is gold-standard epidemiological data that is collected, tested, and audited, and it is used as the basis for public health research and policy.
In the final rule, CMS described this data as “the most complete information that is readily and publicly available,” and noted that, even if there are minor discrepancies in the reporting of such data, there is no evidence to suggest that it would have disproportionate impact on any given OPO, since all OPOs would be evaluated using objective data from the Centers for Disease Control and Prevention.
Additionally, as we wrote in JAMA with D.J. Patil, the chief data scientist of the United States under President Obama, organ donation-eligible deaths are only a small subset of all deaths, and they are uniquely insulated from death certificate errors. Although OPOs have argued that up to 25% of death certificates contain an error, the pertinent question is whether these errors are relevant for organ donation-eligible deaths? In fact, most organ donation-eligible deaths result from strokes, traumas, or drug overdoses, for which misidentification of cause of death is exceedingly rare. For example, in patients with stroke the cause of death is correct nearly 100% of the time. Further mitigating any concerns is that the CDC has a system for auditing and verifying this data after it has been collected (see Quality Control Procedures, pp. 29-30). The small number of irregularities are unlikely to disproportionately impact any given OPO or otherwise complicate CMS’s ability to rely on this data source for comparative evaluation of OPOs.
So we face a stark choice: we can ignore the wealth of research that enforcement of the new rule will be seamless and effective, continue to study the failed performance metrics for OPOs–as we’ve done since as far back as 1997–and allow failing OPOs to retain their government contracts, functionally ensuring more unnecessary deaths. Or we can move forward with sensible reform.
The new rule fixes the previous problem by using the best epidemiological data available to hold OPOs accountable to objective performance. Patients, including the large number of Covid-19 survivors who need organ transplants, will be much better off for it.
Seth Karp, MD, is chairman of the section of surgical sciences and surgeon-in-chief at Vanderbilt University Medical Center. Greg Segal (@GLS613) is the CEO of Organize, a nonprofit patient advocacy organization that served as the Innovator in Residence in the Office of the Secretary of the Department of Health and Human Services under the Obama Administration.