SUPPLEMENTARY INFORMATION:

I. Statutory Authority

LODRP is authorized by 42 U.S.C. 274f (Section 377 of the Public Health Service (PHS) Act, as amended). Most recently, this authority was amended by the HOLD Act (Section 6503 of the Consolidated Appropriations Act, 2026, P. L. 119-75), enacted February 3, 2026.

II. Background

Under section 377 of the PHS Act, as amended,^[1] Congress gives the Secretary of Health and Human Services specific authority to reimburse eligible living donors and donor candidates for qualifying expenses incurred toward living organ donation, with a preference for individuals who the Secretary determines are more likely to be otherwise unable to meet such expenses. Since 2007, HRSA's LODRP has fulfilled this function, reimbursing eligible living organ donor candidates and donors for qualifying non-medical expenses, including travel, meals, lost wages, and child and elder care. Since the program's inception, LODRP (currently operated by the National Living Donor Assistance Center, also known as NLDAC) has received more than 21,000 applications, approving nearly 89 percent of them. During this timeframe, LODRP facilitated over 12,000 living organ donations.

Prior to the enactment of the HOLD Act on February 3, 2026, LODRP's authorizing legislation prohibited donors from receiving reimbursement through the program if they received, or expected to receive, payment related to qualifying non-medical expenses from the recipient of the organ.^[2] Consequently, LODRP's eligibility guidelines centered on recipients' household incomes (HHI), and donors whose intended recipients had HHIs of greater than 350 percent of the HHS Poverty Guidelines ^[3] would not be eligible for reimbursement under LODRP unless the recipient could demonstrate financial hardship.^[4]

The HOLD Act removes recipient income as a factor for determining program eligibility, shifting the program's focus solely to donors' financial need.^[5] Additionally, the HOLD Act requires that, by December 31, 2027, HRSA submit an annual report to Congress with estimates for the number of donors participating in the program who did not receive reimbursement for all qualifying expenses and the total funding needed to fully reimburse donors for all qualifying expenses.^[6]

III. Proposed LODRP Eligibility Guideline Modifications

The current LODRP eligibility guidelines are established through a Federal Register notice (most recently updated in 2020).^[7] HRSA proposes the following changes to the LODRP guidelines to align with the HOLD Act:

i. Removal of Recipient HHI as a Criterion for Eligibility for Reimbursement Under LODRP

Per the HOLD Act, “the recipient of a grant under this section, in providing reimbursement to a donating individual through such grant, shall not give any consideration to the income of the organ recipient.” ^[8] Additionally, the HOLD Act removes the “expectation of payments by organ recipients” as a barrier to eligibility in the program.^[9] To comply with these requirements, HRSA will modify LODRP's eligibility guidelines to remove the recipient's HHI as an eligibility criterion for living donors and donor candidates applying for reimbursement through the program.

While recipient income will no longer be used for program consideration, HRSA will continue to monitor the impact of LODRP on both living organ donors and recipients' increased access to living organ transplants. In order to monitor the impact on recipients, donor applicants will be asked to answer one multiple-choice question on the organ recipient's HHI, with choices including various income ranges and an “I do not know” option for use in cases of non-directed donors, or when the donor applicant does not have a good faith estimate of the recipient's HHI.

Donor applicants will no longer be required to provide written documentation ( e.g., tax documents, pay stubs, etc.) of their intended recipient's HHI and recipients' HHI will not be factored into a donor's eligibility or priority for assistance under LODRP. This change will drastically lower the applicant response burden, consistent with Congressional intent of the HOLD Act, while still enabling HRSA to monitor high-level program impact for both donors and recipients with financial needs being served by LODRP.

ii. Establishment of a Household Income Threshold Eligibility Requirement for Living Organ Donors and Donor Candidates Seeking Reimbursement Through LODRP To Ensure That LODRP Resources are Targeted to Donors With Financial Need

The HOLD Act's removal of recipient HHI as an eligibility factor necessitates the establishment of a donor-focused HHI threshold to ensure LODRP resources continue to go toward individuals with demonstrated financial need. HRSA proposes replacing the current four-tier preference category structure, which conditions eligibility and priority primarily on recipient HHI, with a streamlined, donor-centered framework consisting of two eligibility tiers and a capped financial hardship waiver, applicable to both directed and non-directed donors.

Under the proposed framework, both directed and non-directed donors meeting the criteria for reimbursement will be given preference in the following order of priority:

• Priority Category 1: Donor applicants with HHIs at or below 350 percent of the HHS Poverty Guidelines at the time of the eligibility determination in their respective states of primary residence would receive the highest priority for reimbursement under LODRP.
• Priority Category 2: If sufficient program resources exist, applicants with HHIs between 351 and 500 percent of the HHS Poverty Guidelines would also be eligible to apply for reimbursement.

The cooperative agreement recipient will accept and process applications beginning with Priority Category 1. Each month, the cooperative agreement ( printed page 40007) recipient will report the number of applications received and the amount of donor reimbursement issued over the past 30 days to HRSA. By mid-project period, the cooperative agreement recipient will advise HRSA on whether funding levels allow it to begin accepting and processing applications under additional priority categories. If HRSA and the cooperative agreement recipient determine that funding levels are sufficient to accept Priority Category 2 applications, the cooperative agreement recipient will inform participating transplant programs directly and the public via its website.

HRSA estimates this framework would cover approximately 60 percent of current applicants at the ≤350 percent threshold and approximately 78 percent at the ≤500 percent threshold, including approximately 80 percent of applicants who reported they would be unable to donate without financial support.^[10]

iii. Establishment of a Capped Financial Hardship Waiver for Donor Applicants Whose HHI is Between 501 and 750 Percent of the HHS Poverty Guidelines if Cooperative Agreement Recipient Is Accepting and/or Processing Applications Under Priority Category 2

Under current LODRP guidelines, financial hardship waivers are available to both recipients and donors whose incomes exceed 350 percent of the HHS Poverty Guidelines,^[11] but who face difficulty paying qualifying expenses due to other significant financial obligations. Hardship waivers provide flexibility to serve additional living organ donors and members of the NLDAC Advisory Group, which is comprised of researchers, clinicians, transplant program professionals, living donors, and other stakeholders, have expressed support for maintaining a hardship waiver option.^[12] As a result, financial hardship waivers will continue to be accepted from eligible living organ donors and donor candidates under the revised eligibility guidelines, if the cooperative agreement recipient is accepting and/or processing applications under Priority Category 2.

Under the proposed framework, if the cooperative agreement recipient is accepting and/or processing applications under Priority Category 2, donors with HHIs between 501 and 750 percent of the HHS Poverty Guidelines at the time of the eligibility determination may apply for a financial hardship waiver.

As under current program guidelines, donor waiver requests would be reviewed on a case-by-case basis. Determination of hardship in a particular case will continue to require a fact-specific analysis, but HRSA proposes the following hardship expense categories:

• Lost wages attributable to the donation process and recovery period.
• Travel, lodging, and meals related to the donation process and follow-up appointments.
• Child, elder, or other dependent care costs incurred during the donation process and recovery period.
• Out-of-pocket medical expenses incurred during the donation process.^[13]

Based on a complete evaluation of the donor's financial circumstances, a transplant social worker or other appropriate transplant center representative, will submit the written waiver request on the donor's behalf to the cooperative agreement recipient, attesting that the donor has provided documentation outlining significant expenses that reduce their HHI to below 500 percent of the HHS Poverty Guidelines. The waiver request is then reviewed by the cooperative agreement recipient and subject to final determination by HRSA. HRSA will communicate its final determination to the cooperative agreement recipient, and its determination will not be subject to appeal.

Currently, financial hardship waivers are available without an income ceiling. The income cap (750 percent of the HHS Poverty Guidelines) under the proposed framework reflects the program's renewed focus on donor financial need in alignment with the HOLD Act and ensures that waiver flexibility does not undermine the income-targeting purpose of the proposed eligibility thresholds. Capping waiver eligibility at 750 percent of the HHS Poverty Guidelines will also better target limited program resources and reduce administrative burden relative to an uncapped waiver available at any income level. It is estimated that approximately 92 percent of current donor applicants to the program have incomes at or below 750 percent of the HHS Poverty Guidelines.^[14] HRSA will continue to evaluate the waiver eligibility income cap in operation to assess whether it is necessary in light of current program resources.

iv. Annual Report to Congress Requirement

The HOLD Act requires HRSA to submit an annual report to Congress, by December 31, 2027, with the following data:

• Number of donor applicants not fully reimbursed the previous fiscal year under LODRP.
• Estimated LODRP funding needed to fully reimburse all qualifying expenses for all eligible donor applicants under LODRP.

HRSA anticipates submitting a Paperwork Reduction Act package to the Office of Management and Budget to enable the LODRP cooperative agreement recipient to collect estimates of these data from all eligible living organ donors and donor candidates with approved applications for LODRP reimbursement.

v. Education and Dissemination of Eligibility Guidelines

In FY 2025, HRSA awarded a 3-year cooperative agreement to Health Literacy Media under a new program—Public Education for Living Organ Donation Reimbursement Program—to increase access to LODRP resources among medically underserved communities through education and outreach.

In conjunction with HRSA and the LODRP cooperative agreement recipient, the Public Education for Living Organ Donation Reimbursement Program cooperative agreement recipient will develop and disseminate educational materials informing the public about LODRP eligibility changes as a result of the HOLD Act. Additionally, the LODRP cooperative agreement recipient, through NLDAC, will provide targeted education to transplant professionals to inform them of the new guidelines.

vi. Proposed Living Organ Donation and Reimbursement Program Eligibility Guidelines, as Amended

As provided for in the statutory authorization, LODRP is authorized to provide reimbursement only in those circumstances when payment cannot reasonably be covered by other specified ( printed page 40008) sources of reimbursement. The recipient of the cooperative agreement, under federal law, cannot provide reimbursement to any living organ donor for listed qualifying expenses if the donor can receive reimbursement for these expenses from any of the following sources:

• Any state compensation program, an insurance policy, or any federal or state health benefits program; or
• An entity that provides health services on a prepaid basis.

All persons who wish to become living organ donors are eligible to receive reimbursement for their qualifying expenses if they cannot receive reimbursement from the sources outlined above and if all the requirements outlined in the Criteria for Donor Reimbursement section below are satisfied. However, because reimbursement is subject to the availability of funds, prospective living organ donors who are most likely not able to cover these expenses will receive priority. The ability to cover these expenses is determined based on an evaluation of (1) the donor's HHI in relation to the HHS Poverty Guidelines and (2) financial hardship. As a general matter, income refers to the donor's total household income.

Criteria for Donor Reimbursement

• Any individual who in good faith incurs travel and other qualifying expenses toward the intended donation of an organ.
• Donor and recipient of the organ are U.S. citizens or lawfully present in the United States.
• Donor and recipient have primary residences in the United States or its territories.
• Travel is originating from the donor's primary residence.
• Donor and recipient certify that they understand and are in compliance with Section 301 of National Organ Transplant Act (42 U.S.C. 274e) which states in part that it shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.
• The transplant center where the donation procedure occurs certifies to its status of good standing with the Organ Procurement Transplantation Network.

Priority Categories

Non-directed and directed donors meeting the criteria for reimbursement will be given preference in the following order of priority:

• Priority Category 1: Donor applicants with HHIs at or below 350 percent of the HHS Poverty Guidelines ^[15] at the time of the eligibility determination in their respective states of primary residence would receive the highest priority for reimbursement under LODRP.

• Priority Category 2: If sufficient program resources exist, applicants with HHIs between 351 and 500 percent of the HHS Poverty Guidelines would also be eligible to apply for reimbursement.

The cooperative agreement recipient will accept and process applications beginning with Priority Category 1. Each month, the cooperative agreement recipient will report the number of applications received and the amount of donor reimbursement issued over the past 30 days to HRSA. By mid-project period, the cooperative agreement recipient will advise HRSA on whether funding levels allow it to begin accepting and processing applications under additional priority categories. If HRSA and the cooperative agreement recipient determine that funding levels are sufficient to accept Priority Category 2 applications, the cooperative agreement recipient will inform participating transplant programs directly and the public via its website.

Financial Hardship Waiver

If the LODRP cooperative agreement recipient is accepting and/or processing applications under Priority Category 2, donors with HHIs between 501 and 750 percent of the HHS Poverty Guidelines at the time of the eligibility determination may apply for a financial hardship waiver.

Financial waiver requests will be reviewed on a case-by-case basis. Determination of hardship in a particular case will be based off attestation and documentation of the following types of donation-related expenses incurred by the donor or donor candidate:

• Lost wages attributable to the donation process and recovery period.
• Travel, lodging, and meals related to the donation process and follow-up appointments.
• Child, elder, or other dependent care costs incurred during the donation process and recovery period.
• Out-of-pocket medical expenses incurred during the donation process.^[16]

Based on a complete evaluation of the donor's financial circumstances, a transplant social worker or other appropriate transplant center representative, will submit the written waiver request on the donor's behalf to the cooperative agreement recipient, attesting that the donor has provided documentation outlining significant expenses that reduce their HHI to at or below 500 percent of the HHS Poverty Guidelines. The waiver request is then reviewed by the cooperative agreement recipient and subject to final determination by HRSA. HRSA will communicate its final determination to the cooperative agreement recipient, and its determination will not be subject to appeal.

Qualifying Expenses

The total federal reimbursement for all qualifying expenses during the donation process shall not exceed $6,000 per potential donor evaluated and/or organ donated. For the purposes of LODRP, qualifying expenses include:

• Travel, lodging, meals and incidental expenses incurred by the donor and/or his/her accompanying person(s) as part of:

○ Donor evaluation and/or

○ Hospitalization for the living donor surgical procedure and/or

○ Medical or surgical follow-up, clinic visits, or hospitalization within 2 calendar years following the living donation procedure (or beyond the 2-year period if exceptional circumstances exist).

• Lost wages, child-care expenses, and elder-care expenses incurred by the donor and/or his/her accompanying or assisting person(s) as part of:

○ Donor evaluation and/or

○ Hospitalization for the living donor surgical procedure and/or

○ Non-hospital post-surgery recovery time and/or

○ Medical or surgical follow-up, clinic visits, or hospitalization within 2 calendar years following the living donation procedure (or beyond the 2-year period if exceptional circumstances exist).

The recipient of the cooperative agreement will pay for a total of up to five trips; three for the donor and two for accompanying individuals. However, in cases in which the transplant center requests the donor to return to the transplant center for additional visits as a result of donor complications or other health related issues, the recipient of the cooperative agreement may provide reimbursement for the additional visit(s) for the donor and an accompanying person. The ( printed page 40009) accompanying person need not be the same in each trip.

Reimbursement for travel, lodging, meals, and incidental expenses, as appropriate, shall be provided at the federal per diem rate, except for hotel accommodation, which shall be reimbursed at no more than 150 percent of the federal per diem rate.

Donors may receive up to 4 weeks of reimbursement for lost wages, child-care expenses, and elder-care expenses associated with the surgery and recovery time. In addition, donors may receive reimbursement for up to 2 additional weeks for lost wages, child-care expenses, and elder-care expenses if the donor requires follow-up visits and hospitalization as a result of donor complications or other health-related issues. Reimbursement for lost wages is based on the donor providing appropriate documentation, such as pay stubs, to the program. Reimbursement of lost wages is not limited to traditional wage rate income. Donors may receive reimbursement for non-traditional or irregular income through the program if they provide sufficient documentation of the expected lost wages.

To qualify for reimbursement of child-care expenses and elder-care expenses, a donor shall have caretaker responsibilities for:

• A minor child and/or
• An elder who requires caretaker assistance.

Caretaker responsibilities are not limited to familial relationships between the donor and/or the accompanying or assisting person(s), and the aforementioned individuals. In considering requests for reimbursement for child-care expenses and elder-care expenses, the recipient of the cooperative agreement is encouraged to adopt a consistent application of “child” and “elder.” The recipient of the cooperative agreement may consider applicable laws within the jurisdiction in which the caretaker resides in reviewing requests for reimbursement for expenses for care of a “child,” and, in reviewing requests for reimbursement for elder-care expenses, may consider “elder” to refer to an individual age 60 and older, consistent with the Older Americans Act, 42 U.S.C. 3002(40).

Requests for reimbursement for the expenses of persons accompanying or assisting the donor for travel, housing, meals, and incidental expenses are considered under the preference categories and processed for reimbursement at the same time as requests for reimbursement for expenses incurred by the donor. Requests for reimbursement for the expenses of persons accompanying or assisting the donor for lost wages, child-care expenses, and elder-care expenses are considered under the priority categories and will be processed separately. Requests for these expenses will be processed after all requests for expenses incurred by the donor, and expenses for persons accompanying or assisting the donor for qualifying expenses for travel, housing, meals, and incidental expenses, have been processed under all four preference categories.

Maximum Number of Prospective Donors per Recipient

• Kidney: One donor at a time, with a maximum of three donors.
• Liver: One donor at a time, with a maximum of five donors.
• Lung: Two donors at a time, with a maximum of six donors.

Special Provisions

Many factors may prevent the intended and willing donor from proceeding with the donation. Circumstances that would prevent the transplant or donation from proceeding include present health status of the intended donor or recipient; perceived long-term risks to the intended donor; justified circumstances such as acts of God (major storms or hurricanes); or a circumstance when an intended donor proceeds toward donation in good faith, subject to a case-by-case evaluation by the recipient of the cooperative agreement, but then elects not to pursue donation. In such cases, the intended donor and accompanying persons may receive reimbursement for qualifying expenses incurred as if the donation had been completed. The recipient of the cooperative agreement will file a form with the Internal Revenue Service reporting funds disbursed as income for expenses not incurred.

vii. Other Eligibility Requirements

All other eligibility requirements established under 42 U.S.C. 274f (Section 377 of the PHS Act, as amended) would remain unchanged.

viii. Request for Comment

HRSA invites public comment on the following:

(1) Proposed donor HHI eligibility thresholds and priority categories, as outlined in III.ii of this notice.

(2) Proposed financial hardship waiver cap for donor applicants with HHIs between 501-570 percent of the HHS Poverty Guidelines, as outlined in III.iii of this notice.

(3) Proposed categories for donors' financial hardship expenses as outlined in III.iii of this notice.

(4) Recommendations for forums, resources, and venues to distribute information about LODRP and the program's new eligibility guidelines, including suggestions for community-based outreach and education.

Please indicate which requests for comment (from above) you are responding to and provide recent and accurate quantitative and qualitative data and information to support your comment(s). Please note that comments on other program guidelines are outside of the scope of this Federal Register notice and HRSA will not respond to comments received that do not directly pertain to the above request for comment.

IX. Paperwork Reduction Act of 1995

The proposed changes may result in revisions to information collection requirements subject to review under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

X. Regulatory Impact

This notice does not establish binding requirements and is not a significant regulatory action under Executive Order 12866.

XI. Implementation

After consideration of public comments, HRSA will publish final eligibility guidelines in the Federal Register with the goal of implementing the new guidelines no later than September 1, 2026.

XII. Non-Binding Guidance

This notice sets forth proposed program eligibility guidelines and does not establish legally enforceable rights or obligations. HRSA retains discretion to apply the guidelines based on program requirements and available funding.

91 FR 40005