• Yes. All kidney transplant programs, including all pediatric kidney programs, must assess all newly registered candidates for eGFR waiting time modifications. Please see eligibility criteria in the following question.

Qualifying kidney candidates must meet all the following criteria to be considered eligible:

• They are registered as Black or African American in the OPTN Computer System
• They previously had their eGFR value calculated with a race-inclusive formula
• They are accruing waiting time with eGFR, CrCl, or dialysis criteria (See OPTN Policy 8.3.A)
  OR are registered without qualifying criteria (see next question for details)
• The transplant program can provide documentation demonstrating that with a race-inclusive calculation, the candidate’s eGFR was over 20 mL/min, but with a race-neutral calculation it would have been 20 mL/min or less

Transplant programs may submit waiting time modifications for candidates who were unable to begin accruing waiting time according to OPTN Policy 8.3.A: Waiting Time for Candidates Registered at Age 18 Years or Older at an earlier date due to the use of an eGFR calculation that included a race variable.

• Whether or not dialysis candidate should be included in the scope of eligibility was discussed at length by the Sponsoring Committees.
  • The Sponsoring Committees determined that that Black or African- American candidates on dialysis should be included because these candidates can also be affected by race-inclusive eGFR calculations.
  • The majority of the transplant community agreed with this more inclusive path towards equity for a population of candidates who have been historically disadvantaged.

• While pediatric candidates are typically assessed with different protocols, the OPTN does not know that there are zero pediatric candidates affected by race-inclusive eGFR calculations.
• The Sponsoring Committees leaned on the concept of transparency, therefore the requirements of the policy apply to all kidney candidates regardless of age.

• Candidates who are not registered as Black or African American will not be eligible for an eGFR waiting time modification, as these candidates did not have a race-inclusive calculation used to calculate their eGFR value.

• If a candidate is registered to the waiting list with multiple races and one of those races is Black or African American, it is possible that a calculation that included a race factor was used to calculate their eGFR. Programs can find more details on how to identify their Black or African American candidates in the educational offering in the OPTN Learning Management System (also known as UNOS Connect).
  • KID118: Waiting Time Modifications for Kidney Candidates Affected by Race-Inclusive eGFR Calculations

• This policy is limited to kidney candidates and kidney programs. Candidates registered for a kidney-pancreas or multiple organ transplant are in the scope of eligibility if they are registered for an isolated kidney.

• Yes. Each program will be required to assess their kidney waiting list and submit modifications for all their eligible candidates regardless of whether their candidates are also listed at additional programs.

The OPTN does not collect data on what eGFR calculation was used to accrue waiting time and therefore does not have information on which of the equations were race- inclusive vs. race-neutral.

• The OPTN Data File “Current Waitlisted African American Candidates” is available in the OPTN Computer System Data Services Portal.
  • This custom report provides a list of current kidney candidates reported with African American/Black as a Race category with wait time qualifying information
  • The report is a snapshot of your program’s waiting list at the time it is run. The report will be updated on a weekly basis.
• An educational offering in the OPTN Learning Management System (also known as UNOS Connect) has more information.
  • KID118: Waiting Time Modifications for Kidney Candidates Affected by Race-Inclusive eGFR Calculations

• After January 3, 2024, all kidney programs are required to send all adult and pediatric kidney candidates notification 1 upon registration
  • Notification 1 requires kidney transplant programs to inform their kidney candidates of the policy requirements
  • Notification 2 required kidney transplant programs to inform their candidates of their eligibility status and is NOT required after January 3, 2024

• All newly registered kidney candidates registered at the program, regardless of race, including active and inactive adult and pediatric candidates.

• Patients are at the heart of the system. The OPTN places great importance upon transparency with the entire community, especially patients.
• The OPTN must develop equitable allocation policies. With the identification of this inequitable set of calculations, the OPTN was required to act.

• The transplant hospital should correct this candidate’s race in the OPTN Computer system.
• If the candidate’s race is now Black or African- American, they must be assessed for a waiting time modification.
  • Eligibility will be determined by past use of a race-inclusive eGFR and supporting documentation outlined in the policy. If a race-inclusive eGFR calculation was never used, the candidate will not qualify.

• No. This policy does not specify how a candidate should be contacted. The notifications may be sent as a physical letter. They can also be through other means such as email or through the electronic medical record (EMR).
  • Not all candidates maintain a permanent address, so programs should consider alternative methods of contacting candidates.
• The OPTN encourages transplant programs to retain their own documentation regarding candidate notification.

• A sample notification letter is available on the OPTN website. Transplant programs may access them here.
• The OPTN encourages transplant programs to retain their own documentation regarding candidate notification.
• Additional information to note:
  • Sample notifications were requested by the community, but the policy does not require transplant programs to use them.
  • Sample notifications can be customized to meet the needs of the candidates registered at your program.

• Supporting documentation must demonstrate that with a race-inclusive calculation, the candidate’s eGFR value was over 20 mL/min, but with a race-neutral calculation would have been 20 mL/min or less.
• This criteria for eligibility was established to directly link the use of a race-inclusive eGFR calculation to a candidate's late access to the waiting list. A candidate of any race could experience late access to the waiting list due to late referral, so this requirement aims to focus specifically on those disadvantaged by the use of a race-based eGFR calculation.

Programs may provide documentation aligning with one of the following options:

1. Documentation of the candidate's eGFR value for Black and non-Black candidates: This documentation is reliable and widely available from labs, such as Quest Diagnostics or LabCorp.
2. Documentation showing both the estimation of GFR with a race- inclusive calculation and a re-estimation of GFR with race-neutral calculation: Not every transplant program will have access to the documentation referenced in option 1. Programs without access to larger labs may provide the following two documents to support eGFR waiting time modifications:
   1. A lab report showing estimation of a candidate’s GFR with a race-inclusive calculation, including the date and time of estimation.
   2. Evidence of re-estimation of the candidate’s GFR with any race-neutral eGFR calculation demonstrating a qualifying value.

• Any race-neutral eGFR calculation can be used. This is in alignment with the Establish OPTN Requirement for Race-Neutral eGFR Calculations proposal.

• Yes. The OPTN will accept eGFR waiting time modifications for eligible candidates registered at any time.

• Transplant programs are expected to take the necessary steps to modify waiting times for kidney candidates disadvantaged by the use of a race-inclusive eGFR calculation. To do this, programs are expected to seek documentation by:
  1. Reviewing their own records
  2. Contacting referring nephrologists for additional information
  3. Contacting candidates, who may have additional information

• Candidates qualifying by dialysis: a time earlier than their dialysis start date
• Candidates qualifying by eGFR: a time earlier than their current wait time start date

• Calculations that have been refit without a race variable, such as the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 are race-neutral.
  • An example is included in an educational offering in the OPTN Learning Management System (also known as UNOS Connect).
    • KID118: Waiting Time Modifications for Kidney Candidates Affected by Race-Inclusive eGFR Calculations
• Any program can make a candidate’s eGFR value race- neutral by excluding the race-based variable from the calculation.
  • For example, a program can make the MDRD (Modification of Diet in Renal Disease) 4-variable GFR Equation race-neutral by selecting "no" or “non-Black” when responding the "Black Race" prompt on the calculator. If "no" or “non-Black” is selected, the race variable will not be used to calculate the candidate's eGFR value and the eGFR will be reflective of a race-neutral value.

• Transplant programs are required to submit eGFR Waiting Time Modification forms to the OPTN by fax (804 697 4372) or secure email (OCOperations.Coordinator@unos.org) This form is available in the OPTN Computer System on the Forms/Tools page, accessible through the Resources tab.
• Transplant programs are required to submit a form for each affected candidate, along with supporting documentation.
• An educational offering in the OPTN Learning Management System (also known as UNOS Connect) has more information.
  • KID118: Waiting Time Modifications for Kidney Candidates Affected by Race-Inclusive eGFR Calculations

• Yes. All kidney transplant programs are required to comply with no exceptions.

• Yes. All kidney transplant programs are required to comply with no exceptions.