[Federal Register Volume 85, Number 62 (Tuesday, March 31, 2020)]
[Notices]
[Pages 17894-17896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Reimbursement of Travel and Subsistence Expenses Toward Living 
Organ Donation Program Eligibility Guidelines

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice; request for public comment.

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SUMMARY: HRSA published the final eligibility guidelines for the 
Reimbursement of Travel and Subsistence Expenses toward Living Organ 
Donation Program (herein referred to as Program) in the Federal 
Register on October 5, 2007. HRSA is requesting public comment 
concerning proposed changes to the guidelines to: increase the 
household income eligibility threshold to 350% (currently, the 
threshold is 300%) for living organ donors and organ recipients, 
clarify the use of the existing preference categories in relation to 
the proposed household income eligibility threshold, and clarify that 
travel and subsistence expenses incurred by non-directed living organ 
donors qualify as reimbursable expenses under the Program. HRSA is also 
proposing to revise the Program eligibility guideline's background 
section to ensure that the information aligns with the Program's 
legislative authority. These proposed guidelines would apply to the 
Program regardless of the awardee of the cooperative agreement that 
administers the Program.

DATES: Written comments must be submitted to the office in the address 
section below by mail or email on or before April 30, 2020.

ADDRESSES: Please send all written comments to Frank Holloman, 
Director, Division of Transplantation, Healthcare Systems Bureau, HRSA, 
5600 Fishers Lane, Room 08W53A, Rockville, Maryland 20857; telephone 
(301) 443-7577; or email: [email protected].

FOR FURTHER INFORMATION CONTACT: Frank Holloman, Director, Division of 
Transplantation, Healthcare Systems Bureau, HRSA, 5600 Fishers Lane, 
Room 08W53A, Rockville, Maryland 20857; telephone (301) 443-7577; or 
email [email protected].

SUPPLEMENTARY INFORMATION: The purpose of the Program is to reimburse 
travel and subsistence expenses and other incidental non-medical 
expenses that the Secretary of HHS may authorize by regulation to 
living organ donors and up to two relatives or other individuals 
accompanying the living donor in the United States. Under the statutory 
authority for the Program, if an organ recipient can reasonably be 
expected to pay the living organ donor's travel and subsistence 
expenses related to the organ donation, reimbursement of such expenses 
through the Program is prohibited. The current eligibility guidelines 
further clarify that to be eligible for donor reimbursement, the organ 
recipient's household income must not exceed 300 percent of the HHS 
Poverty Guidelines in effect at the time of the eligibility 
determination. Alternatively, if the organ recipient's household income 
exceeds the threshold, he/she can be eligible to participate in the 
Program if the individual can demonstrate financial hardship. In 
addition, the Program uses a household income threshold of 300 percent 
of the HHS Poverty Guidelines in effect at the time of the eligibility 
determination to prioritize reimbursement for prospective living organ 
donors based on an assessment that donors whose income is below that 
threshold are less likely to be able to cover qualified expenses under 
the Program.
    At the inception of the Program in 2007, HRSA proposed a household 
income eligibility threshold of 200 percent of the HHS Poverty 
Guidelines; however, after reviewing and considering the public 
comments received, HRSA set the Program's initial threshold at 300 
percent of household income. HRSA further determined, based on public 
comment, that organ recipients whose income exceeded this level were 
reasonably able to reimburse living organ donors for travel and 
subsistence expenses as well as for other qualifying expenses 
authorized by the Secretary of HHS, unless the recipients demonstrated 
financial hardship. HRSA also established that donors whose incomes 
fell below this threshold should receive preference over donors whose 
incomes exceeded this threshold.
    The Program's eligibility guidelines have not been amended since 
2009. With the annual number of waiting list deaths hovering between 
6,000 and 7,000 since 2001, the transplant community continues to look 
to living organ donation as a life-saving option for patients in need 
of organ transplants, particularly kidney and liver transplants. As of 
December 31, 2019, approximately 84 percent of the nearly 113,000 
individuals on the national transplant waiting list were waiting for a 
kidney transplant. Even with a record number of close to 40,000 organ 
transplants performed in the United States in 2019, including almost 
7,400 living donor transplants, the gap between demand and availability 
of organs persists.
    In May 2019, the Advisory Committee on Organ Transplantation (ACOT) 
made several recommendations regarding support to living organ donors. 
ACOT advises and provides recommendations to the Secretary through the 
HRSA Administrator on all aspects of organ donation, procurement, 
allocation, and transplantation. ACOT offered three

[[Page 17895]]

recommendations aimed at amending the Program's eligibility guidelines 
to allow for increased access. ACOT recommended increasing the 
household income eligibility threshold to 500 percent of the Federal 
Poverty Limit, waiving income verification when reimbursements do not 
exceed $500, and making non-directed donors eligible for reimbursement 
through the Program if other program requirements are satisfied.
    The Executive Order on Advancing American Kidney Health, issued on 
July 10, 2019, provides increased support for living donors with the 
goal of increasing the supply of transplantable kidneys (https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/). Section 8 of the Executive Order requires the 
Secretary of HHS to, in part, ``. . . raise the limit on the income of 
donors eligible for reimbursement under the [P]rogram.''
    In addition to proposing an increase in income eligibility for the 
reimbursement program through this notice, on December 20, 2019, HRSA 
published a notice of proposed rulemaking designed to further reduce 
financial barriers to living organ donation by expanding the list of 
reimbursable costs to include lost wages and child-care and elder-care 
expenses (84 FR 70139).
    In furtherance of the Executive Order and in light of the ACOT 
recommendations, as well as budgetary constraints, HRSA proposes 
amending the Program eligibility guidelines as follows:
    1. Increasing the household income eligibility threshold for organ 
recipients and prospective living organ donors from the current 300 
percent of the HHS Poverty Guidelines to 350 percent of the HHS Poverty 
Guidelines in effect at the time of eligibility determination;
    2. clarifying the use of the existing preference categories in 
relation to the proposed income eligibility threshold; and
    3. amending the qualifying expenses section of the eligibility 
guidelines to allow the Program to reimburse eligible non-directed 
donors for qualifying expenses.
    Under the first proposed change, the revised income eligibility 
threshold will cover applicants living in nearly 70 percent of the 
households in the United States and potentially increase an important 
source of life-saving organ transplants for the men, women, and 
children on the national transplant waiting list by reducing financial 
barriers to living organ donation. As this proposal would increase the 
income eligibility threshold for organ recipients, and given that 
reimbursement under the Program is not permitted if Program expenses 
can reasonably be expected to be covered by organ recipients, HRSA is 
specifically seeking input from the public regarding whether an organ 
recipient's reasonable ability to pay for a donor's expenses should 
remain tied to the Program's income eligibility threshold and whether 
or not the proposed threshold is appropriate and/or justified. In 2019, 
the HHS Poverty Guideline for a family of four was $25,750.
    The second proposal is to clarify how the Program will use the 
existing preference categories in relation to the proposed income 
eligibility threshold. The Program is currently stratified into 4 
preference categories, which play a role in prioritizing applicants: 
(1) Both donor's and recipient's incomes are below the threshold; (2) 
recipient's income is below the threshold but donor demonstrates 
financial hardship; (3) recipient's income is below the threshold 
regardless of donor's income; and (4) recipient's income is above the 
threshold but demonstrates financial hardship regardless of the donor's 
income. Under this proposal, the Program will accept applications 
primarily from preference category 1, both donor and recipient 
household incomes at or below 350 percent of the HHS Poverty 
Guidelines. However, the Program may accept applications from each 
subsequent category as funds become available. The Program will inform 
participating transplant programs directly and the public via the 
Program's website whenever it plans to accept or stop accepting 
applications from the other preference categories.
    This proposed change will help ensure that HRSA, through this 
Program, supports individuals in need of life-saving transplants who 
are unable to pay for their living donors' travel and related expenses, 
as required by the Program's authorizing legislation. In addition, the 
proposed change will enable living organ donors who are unable to 
afford these expenses to receive preference, as required by the 
Program's authorizing legislation. HRSA is proposing this change to 
ensure that the Program meets its statutory requirement to support 
donor and recipient pairs with the greatest financial needs. The 
Program will regularly track percentages of funds spent against 
percentages of the funds remaining for the budget year.
    The third proposed change is to amend the qualifying expenses 
section of the eligibility guidelines to allow the Program to reimburse 
eligible non-directed donors for qualifying expenses when the intended 
transplant recipient cannot be identified prior to the donation 
process. Living organ donations can be either ``directed'' (the organ 
is intended for an individual named or specified by the living organ 
donor), or ``non-directed'' (the organ is intended for an individual 
neither named nor specified by the donor) as defined at https://optn.transplant.hrsa.gov/resources/ethics/living-non-directed-organ-donation/. Currently, a non-directed living organ donor can only be 
reimbursed for qualified expenses if the intended recipient is 
identified prior to the donation process and the intended recipient 
meets the Program eligibility requirements, including family household 
income. Under the proposed change, all non-directed donors will be 
eligible for reimbursement for qualified expenses. This proposed change 
will allow the Program to support non-directed donors without 
considering the income eligibility of intended transplant recipients, 
if all other donor eligibility criteria are met. Removing this 
financial barrier is expected to increase the number of non-directed 
donors, who often donate anonymously with altruistic motives. In 
addition, because non-directed donors serve as catalysts for paired 
donation kidney chains, this proposed change would provide increased 
access to life-saving organ transplants to more patients on the waiting 
list.
    Additionally, HRSA is proposing to revise the Program eligibility 
guidelines' background section to ensure that the information aligns 
with the Program's legislative authority. The background section 
includes information about the current awardee of the cooperative 
agreement and the mechanism used by the awardee to administer this 
national program. This proposed change will ensure that the background 
covers only the legislative requirements for this Program without 
focusing on the award recipient. This will eliminate the need to revise 
the Program eligibility guidelines in the event of a change to the 
awardee of the cooperative agreement.
    These proposed changes to the eligibility guidelines, if 
implemented, would provide increased access to life-saving organ 
transplants to the thousands of men, women, and children on the 
national transplant waiting list by reducing financial barriers for the 
individuals who wish to become living organ donors. These proposed 
changes are in accordance with the legislative authority codified at 
section 377 of the Public Health Service Act, 42 U.S.C.

[[Page 17896]]

274f, and the Executive Order on Advancing American Kidney Health 
issued on July 10, 2019.

Thomas J. Engels,
Administrator.
[FR Doc. 2020-06628 Filed 3-30-20; 8:45 am]
BILLING CODE 4165-15-P