Dear Secretary Becerra,

Thank you for your thoughtful leadership and commitment to reforming America’s organ donation and transplantation process for the benefit of patients. The National Academies of Sciences, Engineering, and Medicine (NASEM) recently completed a congressionally authorized and funded [1] report entitled Realizing the Promise of Equity in the Organ Transplantation System [2] that provides key recommendations to instill accountability, increase equity, and improve outcomes throughout America’s organ donation ecosystem. We believe this critical research deserves your full attention as it provides clear, actionable recommendations for federal policymakers and represents the evidence-based, peer-reviewed, consensus position of the National Academies.

Regrettably, at the same time that NASEM was conducting its research pursuant to its Congressional mandate, the Department of Health and Human Services (HHS), under the direction of your predecessor, was drafting and unveiling a deeply flawed new Rule [3] governing the performance and evaluation of one component of the transplantation system: Organ Procurement Organizations (OPOs), the non-profit entities tasked with identifying potential donors and obtaining and preserving organs for quick delivery to suitable recipients. While there is certainly need for improvements within the OPO community, the NASEM report makes clear that this is true for the entire transplantation system, and it calls on HHS and Congress to take a holistic and comprehensive approach in order to truly effect change. Furthermore, the Rule itself applies arbitrary and faulty metrics to decertify OPOs and will therefore fail to achieve the accountability, equity, and outcomes that it purports to advance and that patients deserve, and instead will do great harm. We respectfully urge you to carefully consider the extreme dissonance between the NASEM findings and the Rule, and to take urgent corrective action to avert a looming crisis in our nation’s organ transplantation system.

The NASEM report begins by observing that America’s transplantation system contains multiple diverse actors, including patients and donors, physicians, donor hospitals, OPOs, transplant centers, the Organ Procurement and Transplantation Network (OPTN), and the Centers for Medicare & Medicaid Services (CMS), all of which need to be brought into alignment and have robust accountability. NASEM’s research indicates that “the organ transplantation system could save additional lives and be more equitable if its component parts functioned in a more cohesive fashion and were overseen […] in a coordinated fashion with common goals and unified policies and processes.” [4] The report then calls for the development of national performance goals and standardized metrics with which to evaluate the entire system. By contrast, the Rule only addresses one component, OPOs, and imposes new standards and consequences on them alone, whereby those OPOs that under-perform relative to their peers around the country are decertified and must discontinue operations. Moreover, it ranks OPOs on the basis of two metrics: the organ procurement rate, which they control, and the transplantation rate, which they do not control. Transplants are only carried out by transplant centers, and as NASEM explains, those centers often fail to use organs that could be successfully transplanted:

While waiting lists remain long and many listed individuals die while awaiting an organ every day, too many donated organs that are procured and offered to patients at transplant centers are not accepted—leaving thousands of potentially lifesaving donated organs unused every year. […] Evidence indicates that many, if not a large majority, of unused organs could be successfully transplanted and benefit patients. This problem is much more prominent in the United States than in many other countries. For example, the overall nonuse rate in the United States is twice that in France. In the United States, on average, patients who die waiting for a kidney had offers for 16 kidneys that were ultimately transplanted into other patients, indicating that many transplant centers refuse viable kidney offers on behalf of those on the waiting list. [5]

NASEM concludes that “it is too easy for transplant centers to decline usable organs, and accountability for transplant center decision making is lacking.” [6] But perversely, according to the Rule, if a transplant center demonstrates a low transplantation rate then an OPO is punished for that while the transplant center and its underperformance is ignored. This is not to single out the failings of transplant centers, but to demonstrate the absurdity of implementing a policy that evaluates and penalizes only one element of a system – largely based on the performance of another element that may itself need corrective action – rather than developing scientifically grounded accountability measures for the system as a whole.

Regarding equity issues, the NASEM report plainly states that “disparities exist between patients who could benefit and those who are placed on a transplant waiting list based on race, ethnicity, gender, age, socioeconomic status, geographic place of residence and location of the transplant center visited, intellectual ability, and immigration status. For instance, black patients are significantly less likely than white patients to be referred for transplant evaluation and then wait longer for a transplant once listed.” [7] NASEM concludes that the “absence of HHS requirements to collect disaggregated data by race and ethnicity, gender/sex, age, and language in organ donation and transplantation research precludes efforts to fully understand inequities in organ transplantation.” [8]

In contrast, the Rule flatly rejects this notion, stating that “we believe that racial characteristics of the [service area] should not be a reason for risk-adjusting OPO performance” [9] and “we are not aware of a biological reason why race, as an independent factor, would affect the decision to be an organ donor or the number of organs transplanted.” [10] While we can all agree that there is no ‘biological’ difference to account for, this reasoning completely and disturbingly ignores the real issue, which is that race-based and socio-economic disparities in health care access and health care outcomes do exist and must be reckoned with in order to achieve equity. Moreover, it flies in the face of President Biden’s Executive Order On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, which specifically calls for increased collection of this type of disaggregated data in order to better inform federal policymaking. [11]

Finally, NASEM recommends best practices and improvement plans to raise standards across the board in the organ transplantation system, outlines science-based suggestions to do so, and proposes a national goal to boost the total number of successful transplants by 20% between now and 2026. [12] By contrast, the Rule prescribes a Hunger Games style process where OPOs – based on the faulty metrics described above – are simply shuttered. CMS estimated in the final Rule that 22 of the 57 OPOs across America would meet that fate in the first round of closures alone. [13] As a matter of common sense, how would the wholesale closure of nearly 40% of the nation’s organ procurement network possibly result in more transplants?

CMS has asserted that “we would reasonably expect another OPO to take over that service area, retaining the original staff, but changing the leadership and many of the organ procurement practices. Conversely, it is also possible that an OPO taking over a new service area would need to increase its staff or incur costs related to retraining.” [14] Again, why would an OPO willingly absorb another and incur such transaction costs when it is quite possible that doing so would put its own certification at risk in subsequent years? The Rule simply defies logic. The NASEM report lays out a much more coherent roadmap to institute scientifically sound national standards, align the work of physicians, procurement entities and transplantation networks, identify and incentivize best practices, and achieve the ultimate goal of appreciably more successful transplants.

Recent reports have shed light on the ongoing efforts of venture capitalists to influence public policy, [15] and it has been well documented how private equity interests have lobbied for the new regulations as an opportunity to ‘disrupt’ the organ transplantation system for their own gain. [16] They will predictably seek to deflect from the scientific consensus contained in the NASEM report by launching ad hominem attacks on all those who would dare to oppose them, but the facts speak for themselves.

To your credit, you have resisted their calls to accelerate implementation of the Rule and instead opened a request for information (RFI) process that accumulated over 500 public comments raising these concerns and many others. [17] Most recently, in the Administration’s proposed FY23 budget, HHS is requesting to “provide the flexibility CMS needs to avoid organ procurement disruptions due to the certification status of certain organ procurement organizations.” [18] This can only be seen as an acknowledgement that the Rule, if implemented as is, could well lead to the catastrophic collapse of the world’s premier organ transplantation system, putting lives at risk and needlessly prolonging the suffering of all those in need of an organ transplant.

We now implore you to take the obvious next step: pause the Rule while the department implements a formal review of the NASEM report and give all due consideration to its recommendations as Congress intended. We have a shared desire for a more accountable, more equitable, and more productive organ transplantation system. The NASEM report has provided us with the tools to achieve these goals for all the patients and families who need the system to work to its full potential as a matter of life and death. We owe it to them to heed the consensus advice of our scientific community. We look forward to working with you to follow the science and build the stronger, fairer transplantation system that America deserves.

Sincerely,

Anthony Pizzutillo