Notice2026-19911
Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response To Honor Our Living Donors Act
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Published
September 29, 2026
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
On July 1, 2026, HRSA published a notice in the Federal Register to solicit comments on proposed modifications to the Living Organ Donation Reimbursement Program (LODRP or Program) eligibility guidelines in response to the Honor Our Living Donors (HOLD) Act. The HOLD Act, enacted in February 2026, prohibits consideration of an organ recipient's household income in determining a living organ donor's eligibility for reimbursement. This notice responds to the comments received and finalizes the Program Eligibility Guidelines.
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<title>Federal Register, Volume 91 Issue 187 (Tuesday, September 29, 2026)</title>
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[Federal Register Volume 91, Number 187 (Tuesday, September 29, 2026)]
[Notices]
[Pages 61415-61421]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Modification of Living Organ Donation Reimbursement Program
Eligibility Guidelines in Response To Honor Our Living Donors Act
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice of final Living Organ Donation Reimbursement Program
guidelines.
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SUMMARY: On July 1, 2026, HRSA published a notice in the Federal
Register to solicit comments on proposed modifications to the Living
Organ Donation Reimbursement Program (LODRP or Program) eligibility
guidelines in response to the Honor Our Living Donors (HOLD) Act. The
HOLD Act, enacted in February 2026, prohibits consideration of an organ
recipient's household income in determining a living organ donor's
eligibility for reimbursement. This notice responds to the comments
received and finalizes the Program Eligibility Guidelines.
FOR FURTHER INFORMATION CONTACT: Allison Hutchings, Division of
Transplantation, Health Systems Bureau, Health Resources and Services
Administration, 5600 Fishers Lane, Rockville, MD 20857; 240-290-2179 or
<a href="/cdn-cgi/l/email-protection#94f8fde2fdfaf3f0fbfafbe6e7e1e4e4fbe6e0d4fce6e7f5baf3fbe2"><span class="__cf_email__" data-cfemail="7915100f10171e1d1617160b0a0c0909160b0d39110b0a18571e160f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Overview of the Living Organ Donation Reimbursement Program (LODRP)
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. Eligible donors
may receive reimbursement of up to $6,000 per organ donated for
qualifying travel, lost wage, child-care, and elder-care expenses
associated with donor evaluation, the donation surgery, and follow-up
care occurring within two years of the procedure, or beyond that period
in exceptional circumstances. Since the program's inception, LODRP
(currently operated by Mayo Clinic Arizona and the National Living
Donor Assistance Center, also known as NLDAC, via a cooperative
agreement) has received more than 21,000 applications, approving nearly
89 percent of them. During this timeframe, LODRP facilitated over
12,000 living organ donations.
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\1\ 42 U.S.C. 274f.
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II. Summary of Comments Received
On July 1, 2026, HRSA published a notice \2\ in the Federal
Register requesting comments on proposed modifications to the LODRP
eligibility guidelines to implement the HOLD Act, which prohibits
consideration of an organ recipient's household income in determining a
living organ donor's eligibility for reimbursement.\3\
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\2\ HHS, HRSA. ``Modification of Living Organ Donation
Reimbursement Program Eligibility Guidelines in Response to Honor
Our Living Donors Act.'' Federal Register, vol. 91, no. 125, 1 July
2026, pp. 40005-40009, FR Doc. No. 2026-13250,
<a href="http://www.federalregister.gov/documents/2026/07/01/2026-13250/modification-of-living-organ-donation-reimbursement-program-eligibility-guidelines-in-response-to">www.federalregister.gov/documents/2026/07/01/2026-13250/modification-of-living-organ-donation-reimbursement-program-eligibility-guidelines-in-response-to</a>.
\3\ United States Congress, House. Consolidated Appropriations
Act, 2026. H.R. 7148, 119th Congress, 2nd Session. Signed into law 3
Feb. 2026. Public Law 119-75. <a href="http://Congress.gov">Congress.gov</a>, <a href="http://www.congress.gov/bill/119th-congress/house-bill/7148/text">www.congress.gov/bill/119th-congress/house-bill/7148/text</a>.
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The proposed guidelines established a donor-centered eligibility
framework consisting of a first priority category for donors with
household incomes (HHI) at or below 350 percent of the HHS Poverty
Guidelines, a second priority category for donors with HHIs above 350
but no more than 500 percent of the HHS Poverty Guidelines (which would
open mid-project period, subject to available funding), and a capped
financial hardship waiver for donors with HHIs above 500 but no more
than 750 percent of the HHS Poverty Guidelines.
2026 Annual Household Income Thresholds \4\
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48 Contiguous states
Household size and Washington, DC Alaska Hawaii
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500% HHS Poverty Guidelines
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1.......................................... $79,800 $99,750 $91,800
2.......................................... 108,200 135,250 124,450
[[Page 61416]]
3.......................................... 136,600 170,750 157,100
4.......................................... 165,000 206,250 189,750
5.......................................... 193,400 241,750 222,400
6.......................................... 221,800 277,250 255,050
7.......................................... 250,200 312,750 287,700
8.......................................... 278,600 348,250 320,350
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750% HHS Poverty Guidelines
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1.......................................... 119,700 149,625 137,700
2.......................................... 162,300 202,875 186,675
3.......................................... 204,900 256,125 235,650
4.......................................... 247,500 309,375 284,625
5.......................................... 290,100 362,625 333,600
6.......................................... 332,700 415,875 382,575
7.......................................... 375,300 469,125 431,550
8.......................................... 417,900 522,375 480,525
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HRSA requested comments on four specific topics related to the
proposed Program guidelines:
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\4\ HHS, Office of the Assistant Secretary for Planning and
Evaluation. ``2026 Poverty Guidelines.'' <a href="https://aspe.hhs.gov/sites/default/files/documents/b1bfa16b20ae9b89d525bc35de7c1643/detailed-guidelines-2026.pdf">https://aspe.hhs.gov/sites/default/files/documents/b1bfa16b20ae9b89d525bc35de7c1643/detailed-guidelines-2026.pdf</a>.
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(1) The proposed donor HHI eligibility thresholds and priority
categories;
(2) The proposed financial hardship waiver cap for donor applicants
with HHIs between 501 and 750 percent of the HHS Poverty Guidelines;
(3) The proposed categories of donors' financial hardship expenses;
and
(4) Recommendations for forums, resources, and venues to distribute
information about LODRP and the new eligibility guidelines, including
suggestions for community-based outreach and education.
HRSA received a total of 44 comments from the public, including
from prior living donors, transplant centers, organ procurement
organizations, professional and patient stakeholder organizations, and
other interested parties. No commenters opposed the overall shift from
a recipient-income-based framework to a donor-income-based framework.
Comments addressing each of the four numbered topics, as well as those
outside the scope of the specific requests, are summarized below, along
with HRSA's responses.
III. Comments on Proposed Donor HHI Eligibility Thresholds and Priority
Categories
HHI Eligibility Thresholds
Thirty-four commenters expressed explicit support for a shift to a
donor-centered eligibility framework, with many noting that the change
corrects a longstanding barrier under which a donor's eligibility
depended on a recipient's finances rather than the donor's own need.
Seven commenters found the proposed thresholds (at or below 350 percent
of the HHS Poverty Guidelines for Priority Category 1 and 351 to 500
percent for Priority Category 2) reasonable as written.
Others raised concern that a uniform, nationwide income threshold
(i.e., HHS Poverty Guidelines) would not account for significant
differences in cost of living across geographic regions and recommended
that HRSA incorporate regional cost-of-living adjustments into the HHI
thresholds. Four commenters recommended that HRSA eliminate income
thresholds and means-testing altogether so that all donors qualify for
reimbursement regardless of income, and one of these four further
recommended flat-dollar income thresholds in place of HHS Poverty
Guidelines percentages, which vary by household size and may cause
confusion.
HRSA Response: In response to the comments recommending elimination
of income thresholds and means-testing altogether for all donor
applicants, HRSA notes that the authorizing statute requires the
Program to give preference to individuals who are ``more likely to be
otherwise unable to meet such expenses.'' \5\ This requirement makes it
necessary to impose income eligibility parameters on applicants.
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\5\ Reimbursement of Travel and Subsistence Expenses Incurred
toward Living Organ Donation. 42 U.S.C. 274f. Office of the Law
Revision Counsel, U.S. House of Representatives, <a href="https://www.govinfo.gov/link/uscode/42/274f">https://www.govinfo.gov/link/uscode/42/274f</a>.
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Regarding comments recommending regional cost-of-living
adjustments, HRSA acknowledges that a uniform, nationwide HHS Poverty
Guidelines-based threshold does not account for cost-of-living
differences across regions and that donors in high-cost areas may face
hardship at income levels above the proposed thresholds. Given the
magnitude of administrative changes entailed, HRSA does not believe it
would be feasible to develop and implement a reliable geographic
adjustment mechanism or flat-dollar income thresholds at this time;
however, in collaboration with the LODRP cooperative agreement
recipient, HRSA will continue to evaluate whether income eligibility
adjustments are warranted in a future revision of the Program's
eligibility guidelines. In the interim, donors in high-cost areas
facing financial hardship notwithstanding their household income may
apply for the financial hardship waiver described in Section VII of
this notice.
Priority Categories--Phased Opening of Priority Category 2
Nine commenters objected to HRSA's proposal to activate Priority
Category 2 only upon determination of available program resources
rather than at the outset of the project period.
These commenters expressed concern that a delayed or phased opening
of Priority Category 2 could create inequitable outcomes for donors
with similar financial circumstances depending solely on the timing of
their application or donation, could discourage or delay donation while
a recipient's health continues to decline, and could create
administrative confusion for transplant programs counseling prospective
donors. Five commenters recommended that all priority categories be
open to
[[Page 61417]]
applications from the start of the funding period by default, with
categories closed only if and when necessary to preserve funding for
higher-priority applicants. Three of these commenters cited historical
program data indicating that LODRP funds have not been fully expended
in past years and that a substantial share of previously approved
applicants (variously cited as approximately 41 percent) would fall
within the proposed Priority Category 2 income range, suggesting
sufficient funding may exist to open all priority categories
simultaneously. Two commenters recommended that HRSA establish a fixed
annual eligibility schedule or provide advance notice (at least 60
days, per one commenter) before any change in category status, and two
other commenters recommended that previously granted approvals be
protected if a priority category later closes.
HRSA Response: After careful consideration of the comments
received, HRSA has modified the proposed guidelines to enable
applicants to apply to all priority category areas from the start of
the project period, rather than delaying the opening of lower priority
categories. HRSA, in collaboration with the LODRP cooperative agreement
recipient, will monitor application volume and Program expenditures for
each Priority category on a regular basis and provide participating
transplant centers and the public with direct and advance notice if
there is insufficient funding for Priority Categories 2 and 3.
HRSA agrees with the commenters that starting each project period
with all priority categories open and then closing Priority Categories
2 and 3 if HRSA and the cooperative agreement recipient determine that
there is insufficient funding to reimburse applicants in Priority
Category 1 would reduce confusion among applicants and filers,
particularly since this is how the Program has de facto operated since
its inception. However, in response to commenters who expressed
concerns that a delayed opening of lower priority categories would
negatively affect applicants with higher HHIs, HRSA notes that these
applicants would face similar outcomes should the Program need to close
lower priority categories due to funding limitations.
Priority Categories--Hardship Waiver as a Separate Priority Category
Six commenters proposed restructuring the priority categories into
three tiers rather than two, by separating the proposed 501 to 750
percent hardship waiver population into its own distinct preference
category, to provide administrative clarity, and to avoid subjecting
lower-income Category 2 applicants to hardship documentation
requirements intended for a different population. One commenter
recommended that HRSA monitor and publicly report use of the new
categories by geography, race and ethnicity, rurality, insurance
status, and organ type to assess the framework's equity impact.
HRSA Response: HRSA agrees with the recommendation to create a
separate, third category (Priority Category 3) for financial hardship
waiver applicants (i.e., those with HHIs 501 to 750 percent of the HHS
Poverty Guidelines) to ease administrative burden and reduce confusion
among applicants and application filers. Going forward, HRSA, in
collaboration with the cooperative agreement recipient, will closely
monitor application data and plan to publicly report these and other
program data.
IV. Comments on Proposed Capped Financial Hardship Waiver for
Applicants With HHIs 501 to 750 Percent of the HHS Poverty Guidelines
Fourteen of the 43 commenters supported a financial hardship waiver
capped at or near the proposed 750 percent of HHS Poverty Guidelines
threshold, with several citing HRSA's estimate \6\ that the majority of
current applicants (approximately 92 percent) fall at or below this
threshold. One commenter recommended that HRSA periodically reassess
the hardship waiver ceiling after implementation, while another
recommended eliminating the income ceiling for the hardship waiver
altogether. One commenter urged HRSA to decouple waiver eligibility
from Priority Category 2's open/closed status, so the waiver would
remain available whenever the Program is accepting applications
generally and recommended that waiver denials include a written basis
and an opportunity for reconsideration upon additional documentation.
Another commenter suggested that HRSA replace the proposed hardship
waiver mechanism--under which a donor's documented donation-related
expenses must reduce their effective HHI below 500 percent of the HHS
Poverty Guidelines to qualify--with an alternative approach that would
reimburse applicants with HHIs above 501 percent of the HHS Poverty
Guidelines for qualifying expenses exceeding the current $6,000
reimbursement cap, up to the program maximum ($6,000). Finally, several
commenters noted a typographical error in the original Federal Register
request for comment, whereby the hardship waiver income threshold
criteria was listed as 501 to 570 percent of the HHS Poverty
Guidelines, instead of 501-750 percent.
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\6\ As cited in HHS, HRSA. ``Modification of Living Organ
Donation Reimbursement Program Eligibility Guidelines in Response to
Honor Our Living Donors Act.'' Federal Register, Vol. 91, No. 125, 1
July 2026, pp. 40005-40009, FR Doc. No. 2026-13250,
<a href="http://www.federalregister.gov/documents/2026/07/01/2026-13250/modification-of-living-organ-donation-reimbursement-program-eligibility-guidelines-in-response-to">www.federalregister.gov/documents/2026/07/01/2026-13250/modification-of-living-organ-donation-reimbursement-program-eligibility-guidelines-in-response-to</a>.
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HRSA Response: HRSA appreciates the strong support expressed for
the proposed capped financial hardship waiver.
In response to comments recommending that HRSA eliminate the income
ceiling on hardship waiver eligibility, or replace the waiver mechanism
with an alternative reimbursement model, HRSA continues to believe that
a capped hardship waiver, set at 750 percent of the HHS Poverty
Guidelines, best targets the Program's limited resources to donors with
demonstrated financial need while minimizing administrative burden
relative to an uncapped waiver or a more complex alternative
reimbursement structure.
The aforementioned creation of a Priority Category 3 for hardship
waiver applications allows HRSA and the recipient of the cooperative
agreement to open, close, or otherwise manage hardship waiver
applications independently of Priority Category 2, directly addressing
the comment recommending HRSA decouple Priority Category 2 from the
hardship waiver.
HRSA will evaluate and consider the recommendation for a modified
waiver denial and appeal process in future Program guidance and
operational procedures developed in coordination with the LODRP
cooperative agreement recipient. The recommendation to require a
written basis for waiver denials and to permit applicants to submit
additional documentation for hardship waiver would constitute a change
to how the Program currently operates and requires further evaluation
by HRSA and the cooperative agreement recipient.
HRSA concurs with the comment recommending periodic reassessment of
the hardship waiver ceiling following implementation. In collaboration
with the recipient of the cooperative agreement, HRSA will monitor
application volume, approval rates, and other relevant data to evaluate
whether the 750 percent threshold continues to appropriately balance
program access
[[Page 61418]]
with availability of Program resources and will consider adjustments in
future Program eligibility guideline revisions as warranted.
Finally, HRSA acknowledges the typographical error identified by
several commenters in the original request for comment, which
referenced a hardship waiver income range of 501 to 570 percent, rather
than 501 to 750 percent, of the HHS Poverty Guidelines. HRSA confirms
that 501 to 750 percent of the HHS Poverty Guidelines reflects its
intended proposal and has corrected this error in the final guidelines
(see Section VII below).
V. Comments on Proposed Categories of Donors' Financial Hardship
Expenses
Five commenters supported the four proposed expense categories as
sufficient and appropriate without recommending changes. Additionally,
several commenters recommended adding pet care (boarding or in-home
care during recovery) as a qualifying expense, and two of these
commenters also recommended adding care for disabled adults, broadening
the existing ``child-care and elder-care'' language to cover dependents
more generally. Four commenters recommended including a donor
household's broader out-of-pocket medical expenses, not limited to
donation-related costs, as a qualifying hardship expense category; one
of these four commenters also recommended including legally obligated
support payments to a family member outside the household, such as
child support. One commenter recommended explicitly excluding normal
ongoing living expenses (such as routine housing, groceries, and
utilities) as duplicative of the income-based eligibility criteria,
while another commenter recommended including those types of expenses
in the hardship waiver application.
Other comments focused on the burden of applying for hardship, with
one commenter raising concerns about the administrative burden
associated with itemized documentation of numerous expense categories,
particularly for hourly or project-based workers, and recommending that
HRSA consider standardized or flat allowances for certain expense types
(for example, lost wages keyed to State median wage, or mileage
reimbursement modeled on the Federal per diem or IRS mileage rate
structures), with itemized documentation required only above the
standard allowance or in the event of an audit. One commenter urged
HRSA to avoid a detailed, prescriptive expense list altogether and
instead rely on attestations from an authorized transplant center
representative, such as a social worker, to establish a donor's
effective household income for hardship purposes. Finally, another
commenter recommended that HRSA work with the U.S. Department of the
Treasury and the Internal Revenue Service to ensure LODRP reimbursement
is not treated as taxable income to the donor.
HRSA Response: In response to the comments received, HRSA has
expanded the proposed hardship waiver application categories to
explicitly include consideration of pet care and disabled adult care
expenses in the determination of hardship. Additionally, HRSA will
modify the out-of-pocket medical expenses category in the proposed
hardship waiver application to include out-of-pocket medical expenses
(not limited to those related to the donation process) for the whole
household. Finally, HRSA will add a hardship category for regular,
legally mandated payments to support a family member who is not part of
the household, such as child support. HRSA agrees that each of these
expenses is non-discretionary and can have significant effects on a
household's income and thus an individual's ability to proceed with
living donation. Finally, HRSA notes that the proposed qualifying
hardship waiver expenses are merely categories of expenses and that
HRSA will work with the LODRP cooperative agreement recipient to
provide clarity to applicants on the specific expenses that fall within
each category.
HRSA does not agree with the recommendation to include ongoing
household expenses as a hardship waiver category, as these expenses are
already embedded in the HHS Poverty Guideline thresholds. Therefore,
including them in the hardship waiver application would be duplicative.
In response to comments recommending a reduction or removal of
documentation requirements related to the financial hardship waiver,
HRSA reiterates the need for standardized and well-documented hardship
expense categories, not only to promote consistent eligibility
requirements for applicants across transplant centers, but also to
support the Program's ability to withstand audit and ensure appropriate
stewardship of Federal resources. For this reason, HRSA is not adopting
the recommendation to forgo a defined expense list in favor of reliance
on transplant center attestation alone, nor is HRSA adopting
standardized or flat expense allowances in place of itemized
documentation at this time. Finally, HRSA will consult with Treasury
and the Internal Revenue Service to evaluate whether it is feasible for
LODRP reimbursement to be treated as non-taxable income for the donor
once the new Program eligibility guidelines take effect.
VI. Comments on Outreach and Education
Thirteen of the 44 commenters addressed forums, resources, or
venues for disseminating information about LODRP and the new
eligibility guidelines. Ten of these commenters recommended that HRSA
and its cooperative agreement recipient pursue outreach through
professional and clinical channels, including transplant center
evaluation visits, independent living donor advocates, nephrology and
dialysis practices, transplant social workers and financial
coordinators, and professional societies and associations. Four
commenters recommended that educational materials be multilingual and
culturally appropriate, and four commenters specifically recommended
that outreach be targeted to reach medically underserved and minority
communities, which some of these commenters noted face documented
disparities in living-donation rates.
Several of these commenters also recommended that donor financial
assistance information be incorporated into standard informed consent
and intake processes for both donors and recipients, since donors often
raise practical questions with intended recipients before contacting a
transplant center, and recommended that outreach materials prominently
and clearly communicate the elimination of the recipient household
income requirement so that donors and recipients who previously assumed
they were ineligible are made aware of the change. One commenter
recommended that LODRP-related outreach incorporate general messaging
about deceased organ donation, given overlapping community channels and
audiences for donation-related education. Other commenters recommended
specific outreach tools, including a short, plain-language eligibility
screening tool and a publicly available, regularly updated status page
showing which priority categories and the hardship waiver are currently
open.
HRSA Response: HRSA appreciates the suggestions received regarding
outreach and education and will coordinate with the Public Education
for Living Organ Donation Reimbursement Program (PE-LODRP) and LODRP
cooperative agreement recipients, as well as each recipient's Advisory
Board, to ensure that information about the Program is widely
[[Page 61419]]
available and accessible to patients, transplant professionals, and the
general public.
VII. Other/Out-of-Scope Comments
Non-Directed Donor Impact
Five commenters raised concerns specific to non-directed living
donors, who by definition do not have or may not have access to an
identified recipient's financial information. Four of these five
commenters recommended that the final guidelines explicitly state that
non-directed donors are exempt from recipient-related eligibility
criteria and may apply without an identified recipient, consistent with
existing program practice, to avoid an unintended barrier for this
donor population.
HRSA Response: HRSA agrees that the eligibility guidelines should
clearly reflect the Program's existing treatment of non-directed
donors. In response to these comments, HRSA has revised the final
guidelines to expressly state that non-directed donors are exempt from
recipient-related eligibility criteria and documentation requirements
and may apply for reimbursement without an identified recipient,
consistent with current Program practice.
Privacy and Program Integrity
Five commenters raised privacy or program-integrity concerns. Four
of these five recommended that HRSA collect the recipient's estimated
household income directly from the recipient, rather than from the
donor, to protect clinical boundaries and improve data accuracy. One
commenter raised concern about the risk of the Program being used to
facilitate impermissible payment for organs, and recommended informed
consent disclosures regarding financial scrutiny, explicit privacy
protections, and an opt-in application process kept separate from the
transplant care team.
HRSA Response: HRSA appreciates the concerns raised regarding the
collection of recipient household income data and the importance of
maintaining clear clinical and ethical boundaries between donors,
recipients, and the transplant care team. As described in the original
Federal Register notice, HRSA will continue to collect limited, high-
level information on recipient household income to monitor the
Program's impact on recipients' access to living organ transplants.
HRSA intends to submit a separate Paperwork Reduction Act package for
Office of Management and Budget review, public comment, and clearance
that will specify the demographic and other information the recipient
of the cooperative agreement will be required to report to HRSA
regarding the donors, donor candidates, and recipients benefiting from
the Program. Consistent with its role in administering the Program, the
recipient of the cooperative agreement will be responsible for
determining a feasible and accurate method for collecting this
information, which may include collecting recipient household income
directly from the recipient rather than the donor. HRSA encourages the
recipient of the cooperative agreement to consider this recommendation,
among other approaches, in developing its data collection procedures.
In response to the comment expressing concern that the Program
could be used to facilitate impermissible payment for organs, HRSA
notes that the existing eligibility criteria already require both the
donor and the recipient to certify that they understand and are in
compliance with Section 301 of the National Organ Transplant Act (42
U.S.C. 274e), which prohibits the transfer of any human organ for
valuable consideration affecting interstate commerce. HRSA believes
this certification requirement, in conjunction with the transplant
center's certification of good standing with the Organ Procurement and
Transplantation Network, provides an appropriate safeguard against use
of the Program for impermissible payment. HRSA will continue to
evaluate whether additional informed consent disclosures or privacy
protections are warranted as it gains further experience administering
the Program under the revised eligibility guidelines.
Out-of-Scope Comments
Commenters also raised a number of issues outside the scope of the
four numbered requests for comment. Four commenters recommended that
HRSA raise the Program's maximum reimbursement amount, which has
remained at $6,000 since 2007, with some recommending an increase to
$10,000. Two commenters recommended extending the post-donation
reimbursement window for living liver donors, whose recovery period is
longer than for other donor types, from the current 4 weeks to 6 or 8
weeks. Three commenters proposed alternative or supplemental funding
mechanisms to support living donors, including a proposal that insurers
contribute a fee to the Program when a covered member's transplant
results in removal from dialysis, and a proposal for a larger flat
reimbursement amount available to all donors without means-testing.
Five commenters recommended that HRSA conduct or support research,
data collection, or enhanced Congressional reporting on the Program's
impact, including actual donation-related costs, sources of
reimbursement other than the Program, and the experience of donors who
forgo reimbursement. Three commenters recommended ongoing program
monitoring for access, equity, and outcomes following implementation,
particularly with respect to expanding access among lower-income and
historically underserved communities.
Finally, two commenters submitted brief, general statements of
support for the proposed shift to a donor-centered eligibility
framework without addressing a specific numbered request for comment.
HRSA Response: HRSA appreciates this additional feedback but notes
that the comments are out-of-scope for the present proposal. However,
HRSA will consider these recommendations in future revisions to the
Program's eligibility guidelines. With respect to the comments urging
ongoing program monitoring, HRSA intends to work collaboratively with
the recipient of the LODRP cooperative agreement to analyze the effects
of the eligibility guideline modifications implemented in response to
the HOLD Act and will propose further revisions to the guidelines as
needed.
VIII. Final Living Organ Donation Reimbursement Program (LODRP)
Eligibility Guidelines, as Amended
Note: These guidelines apply to all applications reviewed on or
after September 30, 2026. Applications reviewed before this date will
be processed according to the current Program guidelines outlined in
the September 2020 Federal Register Notice.\7\
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\7\ HHS, HRSA. ``Reimbursement of Travel and Subsistence
Expenses Toward Living Organ Donation Program Eligibility
Guidelines.'' Federal Register, vol. 85, No. 184, 22 Sept. 2020, pp.
59530-59534, FR Doc. No. 2020-20805, <a href="http://www.federalregister.gov/documents/2020/09/22/2020-20805/reimbursement-of-travel-and-subsistence-expenses-toward-living-organ-donation-program-eligibility">www.federalregister.gov/documents/2020/09/22/2020-20805/reimbursement-of-travel-and-subsistence-expenses-toward-living-organ-donation-program-eligibility</a>.
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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 sources of
reimbursement. The recipient of the cooperative agreement, under
Federal law, cannot provide reimbursement to any living organ
[[Page 61420]]
donor for listed qualifying expenses if the donor can receive
reimbursement for these expenses from any of the following sources:
<bullet> Any State compensation program, an insurance policy, or
any Federal or State health benefits program; or
<bullet> 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
The following criteria must be met in order for a donor to be
eligible for reimbursement under LODRP:
<bullet> Any individual who in good faith incurs travel and other
qualifying expenses toward the intended donation of an organ.
<bullet> Donor and recipient of the organ are U.S. citizens or
lawfully present in the United States.
<bullet> Donor and recipient have primary residences in the United
States or its Territories.
<bullet> Travel originates from the donor's primary residence.
<bullet> 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.
<bullet> The transplant center where the donation procedure occurs
certifies to its status of good standing with the Organ Procurement
Transplantation Network.
Non-Directed Donors
Because non-directed donors may not have access to or knowledge of
their recipient, they are exempt from recipient-related eligibility
criteria and documentation requirements and may apply for reimbursement
without an identified recipient. Non-directed donors must meet all
other criteria noted above for reimbursement.
Priority Categories
Non-directed and directed donors meeting the criteria for
reimbursement will be given preference in the following order of
priority:
<bullet> Priority Category 1: Donor applicants with HHIs at or
below 350 percent of the HHS Poverty Guidelines \8\ at the time of the
eligibility determination in their respective States of primary
residence would receive the highest priority for reimbursement under
LODRP.
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\8\ HHS Poverty Guidelines for 2026, <a href="https://aspe.hhs.gov/topics/poverty-economic-mobility/poverty-guidelines">https://aspe.hhs.gov/topics/poverty-economic-mobility/poverty-guidelines</a>.
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<bullet> Priority Category 2: If sufficient program resources
exist, applicants with HHIs greater than 350 but no greater than 500
percent of the HHS Poverty Guidelines would also be eligible to apply
for reimbursement.
<bullet> Priority Category 3: If sufficient program resources
exist, applicants with HHIs greater than 500 but no greater than 750
percent of the HHS Poverty Guidelines would also be eligible to apply
for reimbursement via a financial hardship waiver.
At the start of each budget period, the LODRP cooperative agreement
recipient will accept and process applications from all three priority
categories. Each month, the cooperative agreement recipient will report
to HRSA with the number of applications received and the amount of
donor reimbursement issued over the past 30 calendar days. If HRSA and
the cooperative agreement recipient determine that funding levels are
insufficient to continue accepting applicants from Priority Categories
2 and/or 3, the LODRP cooperative agreement recipient will notify
participating transplant programs and the public in a timely fashion
prior to ``closing'' a Priority Category.
Financial Hardship Waiver
Applicants with HHIs greater than 500 but no greater than 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 expenses
incurred by the donor or donor candidate:
<bullet> Lost wages attributable to the donation and/or recovery
period.
<bullet> Travel, lodging, and meals related to the evaluation,
donation and/or follow-up appointments.
<bullet> Child, elder, or other dependent care costs (e.g.,
disabled adult care) incurred during the evaluation, donation, and/or
recovery period.
<bullet> Out-of-pocket medical expenses incurred by the donor
candidate and/or individuals in their household.\9\
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\9\ Note that recipients' health insurance generally covers all
medical expenses related to donation including evaluation, surgery,
and immediate follow-up care.
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<bullet> Pet care costs incurred during the evaluation, donation,
and/or recovery period.
<bullet> Other non-discretionary household expenses (e.g., child
support).
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:
<bullet> Travel, lodging, meals and incidental expenses incurred by
the donor and/or his/her accompanying person(s) as part of:
[cir] Donor evaluation and/or
[cir] Hospitalization for the living donor surgical procedure and/
or
[cir] 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).
<bullet> Lost wages, child care, and elder care expenses incurred
by the donor and/or his/her accompanying or assisting person(s) as part
of:
[cir] Donor evaluation and/or
[cir] Hospitalization for the living donor surgical procedure and/
or
[cir] Non-hospital post-surgery recovery time and/or
[[Page 61421]]
[cir] 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
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.\10\
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\10\ See U.S. General Services Administration site for current
Federal per diem rates: <a href="https://www.gsa.gov/travel/plan-book/per-diem-rates">https://www.gsa.gov/travel/plan-book/per-diem-rates</a>.
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Donors may receive up to 4 weeks of reimbursement for lost wages,
and child care 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, and child care 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, including in industries dependent on tips, through
the program if they provide sufficient documentation of the expected
lost wages.
To qualify for reimbursement of child care and elder care expenses,
a donor shall have caretaker responsibilities for:
<bullet> A minor child;
<bullet> 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 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
and childcare and eldercare 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
For the purposes of LODRP, the maximum number of donor candidates
per recipient who may receive reimbursement through the program at any
given time are listed below:
<bullet> Kidney: One donor at a time, with a maximum of three
donors.
<bullet> Liver: One donor at a time, with a maximum of five donors.
<bullet> Lung: Two donors at a time, with a maximum of six donors.
Annual Report to Congress
The HOLD Act requires HRSA to submit an annual report to Congress,
by December 31, 2027, with the following data:
<bullet> Number of donor applicants not fully reimbursed the
previous fiscal year under LODRP.
<bullet> 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.
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.
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 is a significant regulatory action under Section 3(f)
of Executive Order 12866.
XI. Implementation
The final eligibility guidelines contained in this Federal Register
notice will apply to applications to LODRP reviewed on or after
September 30, 2026.
XII. Other
This guidance aligns with statutory standards and is exempt from
the Administrative Procedure Act (APA) as it pertains to a matter
relating to grants/benefits (5 U.S.C. 553(a)(2)).
Ann M. Sheehy,
Principal Deputy Administrator.
[FR Doc. 2026-19911 Filed 9-28-26; 8:45 am]
BILLING CODE 4165-15-P
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</html>Indexed from Federal Register on September 29, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.