Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Program Eligibility Guidelines, 17894-17896 [2020-06628]

Download as PDF 17894 Federal Register / Vol. 85, No. 62 / Tuesday, March 31, 2020 / Notices 115. Bruce Isenor, New Prague, Minnesota, Court of Federal Claims No: 19–1996V 116. Tracy Renee Ruddy, Auburn, California, Court of Federal Claims No: 19–1998V 117. William Gadd, Fullerton, California, Court of Federal Claims No: 19–2001V 118. Diane D’Amico, Boardman, Ohio, Court of Federal Claims No: 19– 2003V 119. Matthew An, Los Angeles, California, Court of Federal Claims No: 19–2004V 120. Wesley Dumas, New York, New York, Court of Federal Claims No: 19–2007V 121. Deborah Wood, White Plains, New York, Court of Federal Claims No: 19–2008V 122. Richard Robinson, Boston, Massachusetts, Court of Federal Claims No: 19–2011V 123. Thomas Jeffrey Mickles, Greensboro, North Carolina, Court of Federal Claims No: 19–2012V 124. Rosita Smith, Dresher, Pennsylvania, Court of Federal Claims No: 19–2013V 125. Trevor Howell, Washington, District of Columbia, Court of Federal Claims No: 19–2015V 126. Kimberly Draeger, Milwaukee, Wisconsin, Court of Federal Claims No: 19–2016V 127. Howard C. Wilinsky, M.D., Buffalo, New York, Court of Federal Claims No: 19–2017V 128. Troy J. Bodak, Sioux City, Iowa, Court of Federal Claims No: 19– 2019V 129. Alice Rivas, Cheyenne, Wyoming, Court of Federal Claims No: 19– 2020V 130. Donald Doerksen on behalf of Fredda Doerksen, Deceased, Cheyenne, Wyoming, Court of Federal Claims No: 19–2021V 131. Eric Kurtz, M.D., Boston, Massachusetts, Court of Federal Claims No: 19–2022V [FR Doc. 2020–06629 Filed 3–30–20; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES jbell on DSKJLSW7X2PROD with NOTICES Health Resources and Services Administration Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Program Eligibility Guidelines Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). AGENCY: VerDate Sep<11>2014 19:01 Mar 30, 2020 Jkt 250001 Notice; request for public comment. ACTION: 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: donation@hrsa.gov. 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 donation@hrsa.gov. 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 SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\31MRN1.SGM 31MRN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 62 / Tuesday, March 31, 2020 / Notices 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-orderadvancing-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 VerDate Sep<11>2014 19:01 Mar 30, 2020 Jkt 250001 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- PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 17895 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-organdonation/. 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 nondirected 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 lifesaving 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. E:\FR\FM\31MRN1.SGM 31MRN1 17896 Federal Register / Vol. 85, No. 62 / Tuesday, March 31, 2020 / Notices 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Mental Health Special Emphasis Panel, March 24, 2020, 12:00 p.m. to March 24, 2020, 05:00 p.m., National Institutes of Health, 6001 Executive Boulevard, Rockville, MD 20852 which was published in the Federal Register on March 13, 2020, 85 FR 14690. This meeting is being amended to change the date from March 24, 2020 to March 31, 2020. The meeting is closed to the public. Dated: March 25, 2020. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–06692 Filed 3–30–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings jbell on DSKJLSW7X2PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE (P50) I Review. Date: May 18–19, 2020. Time: 8:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. VerDate Sep<11>2014 19:01 Mar 30, 2020 Jkt 250001 Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W116; Rockville, MD 20850 (Telephone Conference Call). Contact Person: Klaus B. Piontek, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, 9609 Medical Center Drive, Room 7W116, National Cancer Institute, Rockville, MD 20892–9750, 240–276–5413, Klaus.Piontek@Nih.Gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE (P50) II Review. Date: May 19–20, 2020. Time: 8:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, 7W244 Rockville, MD 20850 (Telephone Conference Call). Contact Person: John Paul Cairns, Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, 9609 Medical Center Drive, Room 7W244, National Cancer Institute, NIH, Bethesda, MD 20892, 240–276–5415, paul.cairns@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE (P50) III Review. Date: May 20–21, 2020. Time: 8:00 a.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W122, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Anita T. Tandle, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W248, Bethesda, MD 20892, 240–276–5085, Tandlea@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Quantitative Imaging Tools and Methods. Date: May 21, 2020. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W640, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Saejeong J. Kim, Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W640, Rockville, MD 20850, 240–276–7684, saejeong.kim@nih.gov. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee I—Transition to Independence. Date: June 10–11, 2020. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W602, Rockville, MD 20850 (Telephone Conference Call). PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Contact Person: Delia Tang, M.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute. NIH, 9609 Medical Center Drive, Room 7W602, Bethesda, MD 20892, 240–276–6456, tangd@ mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: March 25, 2020. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2020–06691 Filed 3–30–20; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Initial Review; Group Kidney, Urologic and Hematologic Diseases D Subcommittee; DDK–D October 2020 Council. Date: June 23–25, 2020. Time: 5:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Jason D. Hoffert, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 7343, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 496–9010 hoffertj@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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