Advancing health equity continues to be a key initiative for the executive branch, as the Biden administration recently evidenced through initiation of its Equity Action Plans, which outline over 300 strategies for addressing systemic barriers that negatively impact underrepresented communities. Prioritizing effective change to include consideration of equitable healthcare for minorities is also a goal of ongoing investigations in both the Senate and House, which continue to vet the state of the organ donation and transplant system. The combined effect of the executive and legislative interests is forcing providers and other policy makers to proactively reconsider existing policies that may create inequities in organ donation and transplantation practice.
For example, the National Academies of Sciences, Engineering, and Medicine (NASEM) recently took a comprehensive look at ways to improve the organ transplantation system. NASEM’s review found that the U.S. organ transplant system is “demonstrably inequitable,” and the system, as currently structured, can make it less likely for Black patients to be placed on the waitlist in a timely manner due to the use of clinical policies that consider race as a factor in calculating the severity of disease and need for a transplant. More specifically, the NASEM report cites studies indicating that “[r]elatively fewer Black patients are referred, evaluated, and added to a transplant waiting list, and fewer living kidney donations are available to Black patients compared to white patients.”
Noting the apparent bias in the system, NASEM recommended that race be removed from the estimation of kidney health in Organ Procurement and Transplantation Network (OPTN) policies and called for the development of new equations using scientifically validated variables to determine transplantation waitlist criteria. Soon after the release of NASEM’s recommendations, the OPTN responded.
As many of you, especially the surgeons and transplant doctor readers, may already know, the OPTN is the federally designated entity responsible for maintaining the transplantation waitlist and establishing transplant policies applicable to each of its member transplant hospitals, organ procurement organizations, and histocompatibility labs. According to the OPTN, approximately 28% of those currently waiting for an organ transplant are Black. Following the recommendations in the NASEM report and in order to help address these disparities, the Board of Directors of the OPTN unanimously approved a policy requiring the use of race-neutral calculations. The OPTN’s Minority Affairs and Kidney Transplantation Committees sponsored these changes, which affect all policies that reference estimated glomerular filtration rate (eGFR) and require all transplant hospitals to use race-neutral calculations for any purpose covered by OPTN policy.
When calculating waitlist eligibility and placement, physicians use eGFR to assess the extent of a patient’s sickness. eGFR is the “estimated glomerular filtration rate,” which measures how slowly or quickly their kidneys remove creatinine from the blood, and eGFR calculations vary from transplant hospital to transplant hospital with each using different formulas to determine the severity of a patient’s illness. Based on previous clinical studies and medical publications showing that Black patients, on average, have higher levels of creatinine, researchers previously concluded that Black patients’ eGFR scores should be adjusted to account for this discrepancy. Accordingly, because the adjustment for race can erroneously indicate that Black patients are healthier than they actually are (by inflating their eGFR scores), race-based calculations may effectively disadvantage Black patients when determining their place on the transplantation waitlist. More recent studies, however, have shown that there are no inherent biological differences that would necessitate an eGFR adjustment. Additionally, using race as a factor for calculating eGFR doesn’t account for diversity within communities.
As a result, and in an effort to provide the most equitable analysis of waitlist criteria, the OPTN advocated for these new policies. While the OPTN does not develop or dictate specific eGFR calculations, the OPTN does utilize the candidate’s eGFR to determine when a patient is able to begin accruing time on the national kidney transplantation waitlist. Stakeholders are now aware that using race as a factor in calculating eGFR disadvantages Black patients.
In order to begin resolution of this important issue, and to increase access to transplantation, the OPTN proposed and approved the policy, but noted that it would consider future policy changes regarding proposed waitlist credits. This OPTN proposal proffers that transplant hospitals should have a 365-day timeframe to assess their waitlists and submit updated waiting time modifications for affected candidates.
Takeaways
The policy requiring race-neutral eGFR calculations became effective on June 27, 2022. Accordingly, transplant hospitals should take immediate steps to confirm that their respective eGFR calculations do not make adjustments for Black or other minority patients, and adjust accordingly. Pursuant to the policy, transplant hospitals are still free to develop their own eGFR formulas, provided these calculations do not include race as a factor. Transplant hospitals should also consider that implementation of new calculations may necessitate program-wide notice, formal policy revisions, electronic medical record updates, and updated education and training for staff in order to comprehensively account for these critical policy changes.
In addition to meeting these requirements, transplant hospitals should prepare for patient questions about their eGFR calculations, as contemplated by the OPTN’s most recent policy proposal. Transplant hospitals that previously used race-based calculations should develop internal policies and procedures that address reconsideration of and modification to patients’ waitlist credits that may have been adversely affected by race-based calculations. These policies should include a process that contemplates modifications to the date on which transplant candidates qualified for waiting time, which could result in adjusting as far back as the initial date of the candidate’s registration for transplant.
Finally, interested parties should submit a public comment to the current proposal entitled, Modify Waiting Time for Candidates Affected by Race-Inclusive Estimated Glomerular Filtration Rate (eGFR) Calculations, before the deadline on Wednesday Sept. 28, 2022.
Melodie Hengerer, JD, is of counsel in the Health Law Group at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC. She represents a broad range of healthcare providers and organ procurement organizations in navigating complex legal and regulatory challenges. Tenia L. Clayton, JD, is an associate in the Health Law Group at Baker, Donelson, Bearman, Caldwell & Berkowitz, PC. She concentrates her practice on assisting healthcare organizations in a variety of transactional matters, including mergers and acquisitions and other corporate and regulatory matters.
Disclosures
Hengerer is an individual member of the OPTN, but did not participate in the drafting or approval of any policies.
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