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Pre-implementation notice: Requirement for race-neutral eGFR formulas

Pre-implementation notice: Requirement for race-neutral eGFR formulas

*Updated July 20, 2022

Implementation date

  • July 27, 2022

At-a-glance

The Board of Directors of the Organ Procurement and Transplantation Network has approved a policy to require transplant hospitals to use only race-neutral eGFR formulas for data entered into UNet℠, the OPTN computer system. GFR values are used as qualifying measures throughout OPTN policy, and transplant programs and labs should take steps now to comply with the new requirement, which will take effect July 27, 2022.

A transition plan outlined below will allow race-neutral recalculation of certain candidates’ eGFR values and modifications to their waiting times.

What steps to take

At implementation, transplant hospitals will be prohibited from using eGFR calculations that include a race-based variable in OPTN policy. IT changes will also take effect to align associated data collection field labels with the new policy.

All transplant hospitals should take steps to understand what calculations they or their associated labs currently use to estimate GFR, and what actions they will need to take to comply with these changes.

These steps could involve:

  • Program-wide notification of the policy change
  • Training and education for transplant hospital staff
  • Collaboration with laboratory partners to ensure use of race-neutral eGFR calculations
  • Updates to Electronic Medical Records (EMR) systems
  • Informing referring nephrologists and physicians of the changes

This list is not inclusive of all measures a transplant program might expect to take in order to comply with the requirement to use race-neutral eGFR calculations.

Transition procedures for modifying candidate eGFR waiting time

At implementation, transplant hospitals will be able to take immediate action to benefit a select population of Black candidates impacted by race-inclusive eGFR calculations, as described below. Transplant hospital participation in these procedures is optional.

If a transplant hospital:

  • Registered a candidate to the waiting list without a qualifying eGFR value, and at a later date used a race-inclusive eGFR calculation to qualify the candidate to begin accruing waiting time

Then the transplant hospital may:

  • Recalculate the candidate’s eGFR using a race-neutral calculation and update the candidate’s qualifying eGFR date in Waitlist℠

Participating transplant hospitals will be responsible for the identification of Black candidates who qualify for immediate eGFR waiting time modification on their transplant waiting lists.

This could involve:

  • Using the Candidate Report in the Waitlist application to identify potentially affected Black candidates
  • Reviewing potentially affected Black candidates’ registration dates and the calculations used to estimate their GFR

When a Black candidate’s qualifying eGFR is updated in Waitlist, they will be able to gain back any waiting time that would have been accrued after the candidate was originally listed.

Changes to Waitlist data collection labels

Effective July 27, changes will take effect in the Waitlist℠ GFR data collection sections for:

  • kidney
  • kidney-pancreas
  • liver

These changes remove references in the OPTN computer system to specific formulas that may have been used in the past. The specific changes in Waitlist are:

  • Label updates for the GFR data collection sections of kidney, kidney-pancreas, and liver candidate records in Waitlist where measured or estimated GFR is collected
  • Removal of the requirement for users to specify which GFR formula was used for MELD/PELD exceptions due to primary hyperoxaluria

UNet℠ Help Documentation will be updated on July 27 to reflect these changes.

FAQs for professionals and for patients

The OPTN has developed an FAQ for members to answer questions you may have about these changes. There is an additional FAQ resource for patients and the public. Please share this information with patients and their caregivers.

If your patients have general questions about this policy change, you can direct them to OPTN Patient Services 888-894-6361, available Monday-Friday, 8:30 a.m. – 5 p.m. ET.

Follow-on proposal will address listed candidates affected by race-inclusive eGFR calculations

There may be Black candidates registered for transplant who have lost waiting time because they were not listed sooner as a result of race-inclusive calculations. The OPTN eGFR workgroup is developing a pathway for Black candidates whose eGFRs were affected to regain lost waiting time.

This follow-on proposal would give transplant hospitals the opportunity to

  1. Identify potentially affected Black candidates on their kidney waiting lists
  2. Submit requests for modification of these candidates’ waiting time.

The eGFR workgroup plans to propose these changes no later than the summer 2022 public comment period. If approved by the board, changes could provide transplant programs an opportunity to apply potentially impacted candidates for eGFR waiting time modifications. Impacted candidates with approved applications could regain waiting time lost due to use of race-inclusive eGFR calculations.

Background

The OPTN Minority Affairs and Kidney Transplantation Committees co-sponsored the proposal approved by the board. The policy aims to reduce health disparities and address inequities for Black kidney candidates by more accurately estimating their GFR values. The removal of race variables from eGFR calculations has been broadly supported by institutions including the National Academies of Sciences, Engineering and Medicine, as well as a joint task force of the American Society of Nephrology (ASN) and the National Kidney Foundation (NKF). Many transplant hospitals and laboratories have already switched to race-neutral calculations, and this change ensures that all candidates are assessed equitably. Improving equity in access to transplant opportunities for patients is an OPTN strategic goal.

Read the proposal and the winter 2022 public comments, along with the June 2022 board briefing paper.

Post-implementation monitoring

The OPTN will monitor GFR values entered into Waitlist, and provide additional individual member instruction and validation of transition to race-neutral eGFR calculation.

Questions?

Contact member.questions@unos.org with any policy or compliance questions.

 

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