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