The Executive Order on Advancing American Kidney Health (Section 8) directed the Secretary of Health and Human Services (HHS) to propose a regulation to remove financial barriers to living organ donation essentially:

• Expanding the definition of allowable costs that can be reimbursed under the Reimbursement of Travel and Subsistence Expenses Incurred Toward Living Organ Donation program
• Raising the limit on the income of donors eligible for reimbursement under the program
• Allowing reimbursement for lost-wage expenses and providing for reimbursement of child-care and elder-care expenses.
   

ASN supported the proposed rule on Removing Financial Disincentives to Living Organ Donation issued by Health Resources and Services Administration (HRSA) of HHS and recommended further changes in its comment letter to the agency February 18, 2020.

“ASN believes that this proposal could increase the number of transplant recipients receiving a better-quality organ in a shorter time period from living donors. In general, recipients of kidney transplants from living organ donors have better clinical outcomes than those who continue dialysis or those who receive a deceased donor kidney transplant,” wrote Anupam Agarwal, MD, FASN, ASN President.

ASN recommended some refinement of the proposed rule as follows:

• Modifying the language to be more inclusive. In several places, the proposal language implies that the focus is primarily towards familial donors (or close associations) and ASN encourages HRSA to expand that language.
   

While related living donors are the largest donor group, ASN pointed out that there has been a notable decline over the last decade, while unrelated donations have steadily increased – this includes directed donors who may give to a specific recipient when they learn of a need (sometimes without any preexisting relationship – e.g. through social media or other means) and a growing number of non-directed donors (previously called ‘altruistic’) who donate to a list without a directed recipient. Such donors should also have access to the full spectrum of National Living Donor Assistance Center (NLDAC) resources across all phases of donation, including the initial evaluation. Barriers to starting the evaluation can prevent a healthy, otherwise willing, individual from ever becoming a living donor.

• Liberalizing recipient income cap for donor eligibility
   

Eligibility for NLDAC assistance is determined by the recipient’s household income. The recipient’s yearly household income should not be more than 300% of the current Federal Poverty Guidelines, which is currently $38,280 for one individual, otherwise waivers are required.

ASN expressed concern that the current income cap is too low and leaves many potential donor candidates excluded from support. In addition, while the National Organ Transplant Act (NOTA) permits recipients to support costs incurred by donors, the means testing of recipients in the NLDAC program assumes:

1. that a recipient is identified;
2. a donor-recipient relationship with sufficient comfort that the donor can reasonably ask the recipient for financial support, which includes disclosing to the recipient that the individual is pursuing donor candidate evaluation.
    

Due the changing dynamics of donor-recipient relationships,  ASN noted that the relationship with the recipient in these cases can be very different than donation to a family member. The concern that requiring the donor to ask a recipient for financial support during the evaluation phase requires the donor to disclose that they are pursuing the evaluation, denies them the right to be evaluated confidentially, and may create expectations from the receipt that challenge autonomous decision-making – thus posing barrier to, rather than supporting, starting the evaluation process.

• Removing barriers for non-directed donors
   

ASN is concerned that although non-directed donors may apply to NLDAC once a recipient is identified, the delay in the application process creates a barrier for initiation of an evaluation, as non-directed donors do not have an intended recipient at the evaluation stage. Non-directed donors are an extremely impactful group because they often participate in paired donation exchanges that produce a series of transplants from their gift. Non-directed donors should have access to NLDAC support across all phases of care.