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.

Yes, these candidates are considered eligible if:

• Their eGFR value was above 20 when calculated with a race-inclusive eGFR calculation, but upon recalculation with a race-neutral eGFR calculation is 20 mL/min or less.

• This policy requires programs to assess candidates who were listed in this timeframe. Programs may continue to assess and submit modifications for eligible candidates registered after Jan.3, 2024.

• 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

• Before they assess their lists, programs must inform all adult and pediatric kidney candidates of the requirements of the program according to the policy.
• This is the first of two required notifications.
• An educational offering in the OPTN Learning Management System (known as UNOS Connect) has more information.
  • KID118: Waiting Time Modifications for Kidney Candidates Affected by Race-Inclusive eGFR Calculations

• Programs must inform all adult and pediatric kidney candidates of the completion of list assessment and of their eligibility status.
• This is the second of two required notifications.
• 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

• All 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 OPTN also wants to ensure that every candidate is registered with their correct race in the OPTN Computer System. Sending notifications to all candidates will be informative in the event a kidney candidate’s race has been misrepresented in the OPTN Computer System.

• 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.

• Yes. This policy’s candidate notification requirements apply to all kidney candidates, including those registered between Jan. 5, 2023 and Jan. 3, 2024.

• 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.

• The OPTN provides candidate notification samples in OPTN Learning Management System (known as UNOS Connect).
• The OPTN encourages transplant programs to retain their own documentation regarding candidate notification.
  • KID118: Waiting Time Modifications for Kidney Candidates Affected by Race-Inclusive eGFR Calculations
  • 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.

• Currently candidate notification samples are available in Spanish

• 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.

• 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 or secure email. 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

• All affected candidates may provide their transplant program with supporting documentation at any time and are not limited by the January 3, 2024 timeframe
• This timeframe was established for programs to complete the review, submit modifications, send candidate notifications, and submit attestation documentation per OPTN policy

• Documentation attesting to both of the following:
  1. Notification to all candidates registered at the transplant program of their eligibility for a waiting time modification according to this policy and
  2. Submission of eGFR waiting time modifications for all eligible candidates registered at the transplant program

• The OPTN provides attestation sample language in OPTN Learning Management System (known as UNOS Connect).
  • 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.
• Candidates registered until Jan. 3, 2024 must be assessed for eligibility.
• All programs are required to comply with all parts of policy 3.7.D, including the requirement for two candidate notifications.
  • The purpose of the first notification is to give kidney candidates the opportunity to bring forward any supporting documentation that is not within the transplant program’s system
  • During the development of this policy, the sponsoring committees felt strongly that kidney candidates should be given this opportunity to self- advocate

• Yes. All kidney transplant programs are required to comply with no exceptions.
• Candidates registered until Jan. 3, 2024 must be assessed for eligibility.
• All programs are required to comply with all parts of policy 3.7.D, including the requirement for two candidate notifications.
  • The purpose of the first notification is to give kidney candidates the opportunity to bring forward any supporting documentation that is not within the transplant program’s system
  • During the development of this policy, the sponsoring committees felt strongly that kidney candidates should be given this opportunity to self- advocate