Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines and Publication of Final Program Eligibility Guidelines, 57049-57052 [E7-19747]
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Federal Register / Vol. 72, No. 193 / Friday, October 5, 2007 / Notices
collected on these reports is critical for
HRSA, State and local grantees, and
individual providers to evaluate the
effectiveness of these programs.
Number of
grantee respondents
Program under which grantee is funded
Part
Part
Part
Part
Part
Part
The response burden for grantees is
estimated as:
Responses
per grantee
Total Responses
Hours to complete each
form
Total hours
A ...................................................................................
B ...................................................................................
A MAI ...........................................................................
B MAI ...........................................................................
C ...................................................................................
D ...................................................................................
56
59
56
59
361
90
2
2
2
2
2
2
112
118
112
118
722
180
8
12
4
4
7
7
896
1416
448
472
5054
1260
Total ..............................................................................
681
........................
1,362
........................
9,546
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 10–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of this notice.
Dated: October 1, 2007.
Alexandra Huttinger,
Acting Director, Division of Policy Review
and Coordination.
[FR Doc. E7–19721 Filed 10–4–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Reimbursement of Travel and
Subsistence Expenses Toward Living
Organ Donation Proposed Eligibility
Guidelines and Publication of Final
Program Eligibility Guidelines
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Response to Solicitation of
Comments and Publication of Final
Program Eligibility Guidelines.
yshivers on PROD1PC62 with NOTICES
AGENCY:
SUMMARY: A notice was published in the
Federal Register on April 9, 2007 (72 FR
17564). The purpose of this notice was
to solicit comments on the eligibility
criteria that were proposed by HRSA
concerning the Reimbursement of
Travel and Subsistence Expenses Grant
Program.
FOR FURTHER INFORMATION CONTACT:
James F. Burdick, M.D., Director,
Division of Transplantation, Healthcare
Systems Bureau, Health Resources and
Services Administration, Parklawn
Building, Room 12C–06, 5600 Fishers
Lane, Rockville, Maryland 20857;
telephone (301) 443–7577; fax (301)
594–6095; or e-mail: jburdick@hrsa.gov.
SUPPLEMENTARY INFORMATION: Congress
has provided specific authority under
section 377 of the Public Health Service
(PHS) Act, as amended, 42 U.S.C. 274f,
VerDate Aug<31>2005
17:30 Oct 04, 2007
Jkt 214001
for providing reimbursement of travel
and subsistence expenses for living
organ donors, with preference for those
for whom paying such expenses would
create a financial hardship. On
September 25, 2006, HRSA awarded a 4year, $8,000,000 Cooperative Agreement
to the Regents of the University of
Michigan to establish this Program.
Congress requires that the Secretary,
in carrying out this Program, give
preference to those individuals the
Secretary determines are more likely to
be unable to pay for the travel and
related expenses associated with the
donation process. In addition, Congress
requires that funds from the Program
not be used to reimburse travel and
related expenses associated with being a
living donor, if the donor has received
any payments or is expected to receive
any payments related to these expenses
from:
(1) Any State compensation program,
an insurance policy, or a Federal or
State health benefits program;
(2) An entity that provides health
services on a prepaid basis; or
(3) The recipient of the organ.
On April 9, 2007, HRSA published a
notice in the Federal Register,
requesting comments on the proposed
eligibility criteria for the Program.
HRSA outlined that the two main issues
raised in developing program eligibility
criteria are: (1) Criteria to identify
potential living organ donors who may
be unable to pay for travel and
subsistence expenses associated with
living organ donation, since Congress
mandates that these individuals be
given priority for reimbursement; and
(2) criteria to assess the potential organ
recipient’s ability to pay for these
expenses incurred by the living organ
donor, since Congress prohibits
reimbursement of these expenses if the
recipient of the organ can reasonably
pay for these expenses. HRSA proposed
200 percent of the HHS Poverty
Guidelines as an income threshold for
determining which transplant recipients
could reasonably be expected to pay for
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Fmt 4703
Sfmt 4703
travel and subsistence expenses
incurred by the living donor. HRSA
requested comments as to whether this
was a reasonable approach for assessing
a recipient’s ability to pay. HRSA also
proposed some additional criteria
governing donor reimbursement
including: Good faith effort to become a
donor, U.S. legal status, donor informed
consent, compliance with the criminal
provisions contained in section 301 of
the National Organ Transplant Act of
1984, as amended, concerning the
transfer of a human organ for valuable
consideration and requirements of the
transplant program to be in good
standing with the Organ Procurement
and Transplantation Network.
HRSA received 29 public comments
from advocacy groups, transplant
hospitals, and concerned citizens.
Nineteen of these comments expressed
dissatisfaction in limiting
reimbursement to specific donors. The
majority of these respondents remarked
that reimbursement should be available
to all living donors without conditions.
Three of these commenters proposed
that HRSA increase the threshold to 300
percent of the HHS Poverty Guidelines.
One respondent expressed concerns that
the expectation of recipients paying for
donors’ costs and the income guidelines
providing preference for the lowest
socioeconomic class may result in the
exchange of valuable consideration for
the organ or otherwise be coercive
towards individuals of lower
socioeconomic status. Three
respondents stated that they support the
criteria as proposed. One of these two
respondents stated that the Program
should be based on the donor’s ability
to pay, that if people really want to
donate and can afford it, money
shouldn’t be an issue.
One respondent asked HRSA to
protect the rights of all living donors.
Another respondent feels that HRSA is
‘pushing’ the black market by paying
$6,000, which is an insufficient amount,
to living organ donors. Furthermore,
this respondent feels that the Program,
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Federal Register / Vol. 72, No. 193 / Friday, October 5, 2007 / Notices
as outlined, is offensive to living donors
and that no Program would be better
than the Program that is proposed. None
of the respondents explicitly addressed
the criteria for donor reimbursement or
qualifying expenses.
HRSA wishes to thank the
respondents for the quality and
thoroughness of their comments.
HRSA’s response to the comments
received and final decisions are
discussed below.
I. Response to Comment That
Reimbursement Should Be Provided to
All Living Donors Without Regard to
the Financial Situation of the Donor or
Recipient
Most respondents commented that
reimbursement should be available to
all living donors regardless of their
financial situation. The authorizing
statute requires HRSA to give preference
to individuals for whom paying for the
travel and subsistence expenses in the
donation process would be financially
burdensome. Another restriction bars
HRSA from making funds available for
reimbursement to living donors
whenever it is reasonable to expect the
donor to receive reimbursement for
these expenses from other sources
including the recipient of the organ.
Thus, HRSA is required to establish
criteria to assess the donor’s ability to be
reimbursed from these sources. Based
on these restrictions and in an effort to
provide for a transparent and
administratively manageable
mechanism to assess an individual’s
ability to pay for covered expenses,
HRSA believes that the use of the HHS
Poverty Guidelines satisfies these
legislative requirements.
yshivers on PROD1PC62 with NOTICES
II. Response to Comment To Increase
the Income Threshold to 300 Percent of
the HHS Poverty Guidelines
In addition to the 19 respondents who
believe that reimbursement should be
available to all living donors, three
respondents proposed that HRSA
increase the income threshold to 300
percent of the HHS Poverty Guidelines
for both donors and recipients. After
further deliberations, HRSA accepted
this recommendation. Individuals in
need of a transplant face many financial
obligations such as direct medical
expenses, insurance co-pays,
medications, etc., associated with endstage organ failure. Similarly, potential
donors face the potential loss of income
and other expenses that may increase as
a result of the donation. It is the hope
of HRSA that this change will help to
ease the burden for both donors and
recipients.
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III. Response to Concern Over
Expectation by the Organ Donor That
Recipient Should Pay Donor’s Expenses
One respondent expressed concerns
about the expectation that the recipient
pay for the donor’s expenses. As stated
previously, the authorizing statute
requires that HRSA consider the
recipient’s ability to pay.
IV. Response to Comment That All
Organ Donors Deserve This Gift for
Their Sacrifice
The majority of respondents
commented that all donors should
receive reimbursement under this
Program. The most frequent reason
stated was that donors deserve this gift
for their sacrifice. The authorizing
legislation does not intend the payment
authorized under this program to be a
gift or recognition for the sacrifice of the
donor or as an enticement to donate.
The intent is to ease the financial
burden on those individuals who make
the altruistic decision to donate and to
give priority to those who have no other
available sources to pay for travel and
subsistence expenses associated with
the donation.
V. Response to Comment That Overall
Reimbursement Level Should Exceed
$6,000
Eight respondents mentioned the
$6,000 level in their comments. HRSA
wishes to clarify that $6,000 is the
ceiling or reimbursement cap for each
donor participating in the Program. The
Program will provide reimbursement for
only the qualifying expenses outlined in
the final eligibility criteria. The
eligibility criteria provide more details
on qualifying expenses.
Conclusion
HRSA has reviewed and considered
all comments and has revised certain
eligibility criteria as appropriate. HRSA
will continually monitor the progress of
the Program grantee, the Regents of the
University of Michigan, to ensure that it
adheres to the Program eligibility
criteria in the operation of the National
Living Donor Assistance Center. The
final eligibility criteria are included in
this document. The final eligibility
criteria guidelines document is also
available at https://
www.livingdonorassistancecenter.gov.
National Living Donor Assistance
Center (NLDAC) Program Eligibility
Guidelines
Section 3 of the Organ Donation and
Recovery Improvement Act (ODRIA), 42
U.S.C. 274f, establishes the authority
and legislative parameters to provide
reimbursement for travel and
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Sfmt 4703
subsistence expenses incurred towards
living organ donation. HRSA awarded a
cooperative agreement to the Regents of
the University of Michigan (Michigan),
which partnered with the American
Society of Transplant Surgeons (ASTS),
to establish the National Living Donor
Assistance Center (NLDAC) to operate
this Program.
As provided for in the statutory
authorization, this Program is intended
to provide reimbursement only in those
circumstances when payment cannot
reasonably be covered by other sources
of reimbursement. The NLDAC, under
Federal law, cannot provide
reimbursement to any living organ
donor for travel and other qualifying
expenses if the donor can receive
reimbursement for these expenses from
any of the following sources:
(1) Any State compensation program,
an insurance policy, or any Federal or
State health benefits program;
(2) an entity that provides health
services on a prepaid basis; or
(3) the recipient of the organ.
In response to public solicitation of
comments, a threshold of income
eligibility for the recipient of the organ
is 300 percent of the Department of
Health and Human Services (HHS)
Poverty Guidelines in effect at the time
of the eligibility determination. The
Program assumes that recipients whose
income exceeds this level will have the
ability to reimburse the living organ
donor for the travel and subsistence
expenses and any other qualifying
expenses that can be authorized by the
Secretary of HHS. The Program provides
an exception to this rule for financial
hardships. A transplant social worker,
or appropriate transplant center
representative, based on a complete
recipient evaluation, can provide an
official statement, notwithstanding the
recipient’s income level, that the
recipient of the organ would face
significant financial hardship if required
to pay for the qualifying living organ
donor expenses. A recipient’s financial
hardship is defined as circumstances in
which the recipient’s income exceeds
300 percent of the HHS Poverty
Guidelines in effect at the time of the
eligibility determination, but the
individual will have difficulty paying
the donor’s expenses due to other
significant expenses. Whether or not
hardship exists in a particular case
requires a fact-specific analysis;
examples of significant expenses
include circumstances such as paying
for medical expenses not covered by
insurance or providing significant
financial support for a family member
not living in the household (e.g., elderly
parent). Waiver requests by the
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Federal Register / Vol. 72, No. 193 / Friday, October 5, 2007 / Notices
transplant center, on behalf of the
donor, shall be made in writing and
shall clearly describe the circumstances
for the waiver request. The NLDAC will
review waiver requests and make a
recommendation to HRSA to either
approve or deny the request. HRSA will
make the final determination and
communicate its final determination to
the NLDAC. The NDLAC will notify the
transplant center of the final
determination. HRSA’s determination
will not be subject to appeal.
All persons who wish to become
living organ donors are eligible to
receive reimbursement for their travel
and qualified expenses if they cannot
receive reimbursement from the sources
outlined above and if all the
requirements outlined in the Criteria for
Donor Reimbursement Section are
satisfied. However, because of the
limited funds available, prospective
living 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 and recipient’s income, in
relation to the HHS Poverty Guidelines
(described in Table 1.1 below), and (2)
financial hardship. As a general matter,
income refers to the donor or recipient’s
total household income. A donor may
be able to demonstrate financial
hardship, even if the donor’s income
exceeds 300 percent of the HHS Poverty
Guidelines, if the donor will have
difficulty paying the qualifying
expenses due to other significant
expenses. Although all requests will be
reviewed on a case-by-case basis,
examples of significant expenses
include circumstances such as
providing significant financial support
for a family member not living in the
household (e.g., elderly parent), loss of
income due to donation process. Waiver
requests by the transplant center, on
behalf of the donor, shall be made in
writing and shall clearly describe the
circumstances for the waiver request.
The NLDAC will review waiver requests
and make a recommendation to HRSA
to either approve or deny the request.
HRSA will make the final determination
and communicate its final
determination to the NLDAC. The
NLDAC will notify the transplant center
of the final determination. HRSA’s
determination will not be subject to
appeal.
Donors will be given preference in the
following order of priority:
Preference Category 1: The donor’s
income and the recipient’s income are
each 300 percent or less of HHS Poverty
Guidelines in effect at the time of the
eligibility determination in their
respective states of primary residence.
Preference Category 2: Although the
donor’s income exceeds 300 percent of
57051
the HHS Poverty Guidelines in effect in
the State of primary residence at the
time of the eligibility determination, the
donor demonstrates financial hardship.
The recipient’s income is at or below
300 percent of the HHS Poverty
Guidelines in effect in the State of
primary residence at the time of the
eligibility determination.
Preference Category 3: Any living
organ donor, regardless of income or
financial hardship, if the recipient’s
income is at or below 300 percent of the
HHS Poverty Guidelines in effect in the
recipient’s State of primary residence at
the time of the eligibility determination.
Preference Category 4: Any living
organ donor, regardless of income or
financial hardship, if the recipient (with
income above 300 percent of the HHS
Poverty Guidelines in effect in the State
of primary residence at the time of the
eligibility determination) demonstrates
financial hardship.
HRSA reserves the right to prioritize
those most in financial need (based on
income or other specified factors) if it
receives large numbers of applications
concerning donors meeting preference
category 1.
The HHS Poverty Guidelines for 2007
(Federal Register, Vol. 72, No. 15,
January 24, 2007, pp. 3147–3148) are
shown in the table below.
2007 HHS POVERTY GUIDELINES
48 Contiguous
States and DC
Persons in family or household
1 .................................................................................................................................
2 .................................................................................................................................
3 .................................................................................................................................
4 .................................................................................................................................
5 .................................................................................................................................
6 .................................................................................................................................
7 .................................................................................................................................
8 .................................................................................................................................
For each additional person, add ................................................................................
Alaska
$10,210
13,690
17,170
20,650
24,130
27,610
31,090
34,570
3,480
$12,770
17,120
21,470
25,820
30,170
34,520
38,870
43,220
4,350
Hawaii
$11,750
15,750
19,750
23,750
27,750
31,750
35,750
39,750
4,000
Source: Federal Register, Vol. 72, No. 15, January 24, 2007, pp. 3147–3148.
These guidelines are updated periodically.
yshivers on PROD1PC62 with NOTICES
Criteria for Donor Reimbursement
1. Any individual who in good faith
incurs travel and other qualifying
expenses toward the intended donation
of an organ.
2. Donor and recipient of the organ
are U.S. citizens or lawfully admitted
residents of the U.S.
3. Donor and recipient have primary
residences in the U.S. or its territories.
4. Travel is originating from the
donor’s primary residence.
5. Donor and recipient certify that
they understand and are in compliance
with Section 301 of NOTA (42 U.S.C.
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15:33 Oct 04, 2007
Jkt 214001
274e) which states in part ‘‘* * * 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.’’
6. The transplant center where the
donation procedure occurs certifies to
its status of good standing with the
Organ Procurement and Transplantation
Network (OPTN).
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Qualifying Expenses
For the purposes of the
Reimbursement of Travel and
Subsistence Expenses toward Living
Organ Donation Program, qualifying
expenses presently include only travel,
lodging, and meals and incidental
expenses incurred by the donor and/or
his/her accompanying person(s) as part
of:
(1) Donor evaluation, clinic visit or
hospitalization,
(2) Hospitalization for the living
donor surgical procedure, and/or
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Federal Register / Vol. 72, No. 193 / Friday, October 5, 2007 / Notices
(3) Medical or surgical follow-up
clinic visit or hospitalization within 90
days following the living donation
procedure.
The Program will pay for a total of up
to five trips; three for the donor and two
for accompanying persons. The
accompanying persons need not be the
same each trip.
The total Federal reimbursement for
qualified expenses during the donation
process for the donor and accompanying
individuals shall not exceed $6,000.00.
Reimbursement for qualifying expenses
shall be provided at the Federal perdiem rate, except for hotel
accommodation, which shall be
reimbursed at no more than 150 percent
of the Federal per diem rate.
For donor and recipient pairs
participating in a paired exchange
program, the applicable eligibility
criteria for the originally intended
recipient shall be considered for the
purpose of reimbursement of qualifying
donor expenses even though the final
recipient of the donated organ may not
be the recipient identified in the
original donor-recipient pair.
Maximum Number of Prospective
Donors per Recipient
• Kidney: One donor at a time with a
maximum of three donors.
• Liver: One donor at a time with a
maximum of five donors.
• Lung: Two donors at a time with a
maximum of six donors.
yshivers on PROD1PC62 with NOTICES
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 (e.g., 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 NLDAC, but then
elects not to pursue donation. In such
cases, the intended donor and
accompanying persons may receive
reimbursement for qualified expenses
incurred as if the donation had been
completed. Under Program policy, a
form will be filed with the Internal
Revenue Service (IRS) reporting funds
disbursed as income for expenses not
incurred.
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15:33 Oct 04, 2007
Jkt 214001
Dated: October 1, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–19747 Filed 10–4–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Law Enforcement Training
Center
[Docket No. FLETC–2007–0002]
Advisory Committee to the Office of
State and Local Training
Federal Law Enforcement
Training Center (FLETC), DHS.
ACTION: Committee Management; Notice
of Federal Advisory Committee Meeting.
AGENCY:
SUMMARY: The Office of State and Local
Training Advisory Committee
(OSLTAC) will meet on November 8,
2007, on St. Simons Island, GA. The
meeting will be open to the public.
DATES: The Office of State and Local
Training Advisory Committee will meet
Thursday, November 8, 2007, from 8
a.m. to 4 p.m. Please note that the
meeting may close early if the
committee has completed its business.
ADDRESSES: The meeting will be held at
Epworth By The Sea, 100 Arthur J.
Moore Drive, St. Simons Island, GA.
Send written material, comments, and/
or requests to make an oral presentation
to the contact person listed below by
October 19th. Requests to have a copy
of your material distributed to each
member of the committee prior to the
meeting should reach the contact person
at the address below by October 19th.
Comments must be identified by
FLETC–2007–0002 and may be
submitted by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: reba.fischer@dhs.gov.
Include docket number in the subject
line of the message.
• Fax: (912) 267–3531. (Not a toll-free
number.)
• Mail: Reba Fischer, Designated
Federal Officer (DFO), Federal Law
Enforcement Training Center,
Department of Homeland Security, 1131
Chapel Crossing Road, Townhouse 396,
Glynco, GA 31524.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number for this action. Comments
received will be posted without
alteration at www.regulations.gov,
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Frm 00072
Fmt 4703
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including any personal information
provided.
Docket: For access to the docket to
read background documents or
comments received by the Advisory
Committee to the Office of State and
Local Training, go to
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Reba Fischer, Designated Federal
Officer, Federal Law Enforcement
Training Center, Department of
Homeland Security, 1131 Chapel
Crossing Road, Townhouse 396, Glynco,
GA 31524; (912) 267–2343;
reba.fischer@dhs.gov.
Notice of
this meeting is given under the Federal
Advisory Committee Act, 5 U.S.C. App.
(Pub. L. 92–463). The mission of the
Advisory Committee to the Office of
State and Local Training is to advise
and make recommendations on matters
relating to the selection, development,
content and delivery of training services
by the OSL/FLETC to its state, local,
campus, and tribal law enforcement
customers.
Draft Agenda: The draft agenda for
this meeting includes briefings to
update committee members on OSL and
FLETC training initiatives and provide
feedback on committee
recommendations. Committee members
will be asked to provide
recommendations on OSL strategic
planning; training needs of state, local,
campus, and tribal law enforcement
officers; and upcoming training
initiatives.
Procedural: This meeting is open to
the public. Please note that the meeting
may close early if all business is
finished.
Visitors must pre-register attendance
to ensure adequate seating. Please
provide your name and telephone
number by close of business on October
19, 2007, to Reba Fischer (contact
information above).
Information on Services for
Individuals with Disabilities: For
information on facilities or services for
individuals with disabilities or to
request special assistance at the
meeting, contact Reba Fischer as soon as
possible.
SUPPLEMENTARY INFORMATION:
Dated: September 25, 2007.
Malcolm Adams,
Acting Deputy Assistant Director, Office of
State and Local Law Enforcement Training.
[FR Doc. 07–4958 Filed 10–4–07; 8:45 am]
BILLING CODE 4810–32–P
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]]>Agencies
[Federal Register Volume 72, Number 193 (Friday, October 5, 2007)]
[Notices]
[Pages 57049-57052]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19747]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Reimbursement of Travel and Subsistence Expenses Toward Living
Organ Donation Proposed Eligibility Guidelines and Publication of Final
Program Eligibility Guidelines
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Response to Solicitation of Comments and Publication of Final
Program Eligibility Guidelines.
-----------------------------------------------------------------------
SUMMARY: A notice was published in the Federal Register on April 9,
2007 (72 FR 17564). The purpose of this notice was to solicit comments
on the eligibility criteria that were proposed by HRSA concerning the
Reimbursement of Travel and Subsistence Expenses Grant Program.
FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director,
Division of Transplantation, Healthcare Systems Bureau, Health
Resources and Services Administration, Parklawn Building, Room 12C-06,
5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443-7577;
fax (301) 594-6095; or e-mail: jburdick@hrsa.gov.
SUPPLEMENTARY INFORMATION: Congress has provided specific authority
under section 377 of the Public Health Service (PHS) Act, as amended,
42 U.S.C. 274f, for providing reimbursement of travel and subsistence
expenses for living organ donors, with preference for those for whom
paying such expenses would create a financial hardship. On September
25, 2006, HRSA awarded a 4-year, $8,000,000 Cooperative Agreement to
the Regents of the University of Michigan to establish this Program.
Congress requires that the Secretary, in carrying out this Program,
give preference to those individuals the Secretary determines are more
likely to be unable to pay for the travel and related expenses
associated with the donation process. In addition, Congress requires
that funds from the Program not be used to reimburse travel and related
expenses associated with being a living donor, if the donor has
received any payments or is expected to receive any payments related to
these expenses from:
(1) Any State compensation program, an insurance policy, or a
Federal or State health benefits program;
(2) An entity that provides health services on a prepaid basis; or
(3) The recipient of the organ.
On April 9, 2007, HRSA published a notice in the Federal Register,
requesting comments on the proposed eligibility criteria for the
Program. HRSA outlined that the two main issues raised in developing
program eligibility criteria are: (1) Criteria to identify potential
living organ donors who may be unable to pay for travel and subsistence
expenses associated with living organ donation, since Congress mandates
that these individuals be given priority for reimbursement; and (2)
criteria to assess the potential organ recipient's ability to pay for
these expenses incurred by the living organ donor, since Congress
prohibits reimbursement of these expenses if the recipient of the organ
can reasonably pay for these expenses. HRSA proposed 200 percent of the
HHS Poverty Guidelines as an income threshold for determining which
transplant recipients could reasonably be expected to pay for travel
and subsistence expenses incurred by the living donor. HRSA requested
comments as to whether this was a reasonable approach for assessing a
recipient's ability to pay. HRSA also proposed some additional criteria
governing donor reimbursement including: Good faith effort to become a
donor, U.S. legal status, donor informed consent, compliance with the
criminal provisions contained in section 301 of the National Organ
Transplant Act of 1984, as amended, concerning the transfer of a human
organ for valuable consideration and requirements of the transplant
program to be in good standing with the Organ Procurement and
Transplantation Network.
HRSA received 29 public comments from advocacy groups, transplant
hospitals, and concerned citizens. Nineteen of these comments expressed
dissatisfaction in limiting reimbursement to specific donors. The
majority of these respondents remarked that reimbursement should be
available to all living donors without conditions. Three of these
commenters proposed that HRSA increase the threshold to 300 percent of
the HHS Poverty Guidelines. One respondent expressed concerns that the
expectation of recipients paying for donors' costs and the income
guidelines providing preference for the lowest socioeconomic class may
result in the exchange of valuable consideration for the organ or
otherwise be coercive towards individuals of lower socioeconomic
status. Three respondents stated that they support the criteria as
proposed. One of these two respondents stated that the Program should
be based on the donor's ability to pay, that if people really want to
donate and can afford it, money shouldn't be an issue.
One respondent asked HRSA to protect the rights of all living
donors. Another respondent feels that HRSA is `pushing' the black
market by paying $6,000, which is an insufficient amount, to living
organ donors. Furthermore, this respondent feels that the Program,
[[Page 57050]]
as outlined, is offensive to living donors and that no Program would be
better than the Program that is proposed. None of the respondents
explicitly addressed the criteria for donor reimbursement or qualifying
expenses.
HRSA wishes to thank the respondents for the quality and
thoroughness of their comments. HRSA's response to the comments
received and final decisions are discussed below.
I. Response to Comment That Reimbursement Should Be Provided to All
Living Donors Without Regard to the Financial Situation of the Donor or
Recipient
Most respondents commented that reimbursement should be available
to all living donors regardless of their financial situation. The
authorizing statute requires HRSA to give preference to individuals for
whom paying for the travel and subsistence expenses in the donation
process would be financially burdensome. Another restriction bars HRSA
from making funds available for reimbursement to living donors whenever
it is reasonable to expect the donor to receive reimbursement for these
expenses from other sources including the recipient of the organ. Thus,
HRSA is required to establish criteria to assess the donor's ability to
be reimbursed from these sources. Based on these restrictions and in an
effort to provide for a transparent and administratively manageable
mechanism to assess an individual's ability to pay for covered
expenses, HRSA believes that the use of the HHS Poverty Guidelines
satisfies these legislative requirements.
II. Response to Comment To Increase the Income Threshold to 300 Percent
of the HHS Poverty Guidelines
In addition to the 19 respondents who believe that reimbursement
should be available to all living donors, three respondents proposed
that HRSA increase the income threshold to 300 percent of the HHS
Poverty Guidelines for both donors and recipients. After further
deliberations, HRSA accepted this recommendation. Individuals in need
of a transplant face many financial obligations such as direct medical
expenses, insurance co-pays, medications, etc., associated with end-
stage organ failure. Similarly, potential donors face the potential
loss of income and other expenses that may increase as a result of the
donation. It is the hope of HRSA that this change will help to ease the
burden for both donors and recipients.
III. Response to Concern Over Expectation by the Organ Donor That
Recipient Should Pay Donor's Expenses
One respondent expressed concerns about the expectation that the
recipient pay for the donor's expenses. As stated previously, the
authorizing statute requires that HRSA consider the recipient's ability
to pay.
IV. Response to Comment That All Organ Donors Deserve This Gift for
Their Sacrifice
The majority of respondents commented that all donors should
receive reimbursement under this Program. The most frequent reason
stated was that donors deserve this gift for their sacrifice. The
authorizing legislation does not intend the payment authorized under
this program to be a gift or recognition for the sacrifice of the donor
or as an enticement to donate. The intent is to ease the financial
burden on those individuals who make the altruistic decision to donate
and to give priority to those who have no other available sources to
pay for travel and subsistence expenses associated with the donation.
V. Response to Comment That Overall Reimbursement Level Should Exceed
$6,000
Eight respondents mentioned the $6,000 level in their comments.
HRSA wishes to clarify that $6,000 is the ceiling or reimbursement cap
for each donor participating in the Program. The Program will provide
reimbursement for only the qualifying expenses outlined in the final
eligibility criteria. The eligibility criteria provide more details on
qualifying expenses.
Conclusion
HRSA has reviewed and considered all comments and has revised
certain eligibility criteria as appropriate. HRSA will continually
monitor the progress of the Program grantee, the Regents of the
University of Michigan, to ensure that it adheres to the Program
eligibility criteria in the operation of the National Living Donor
Assistance Center. The final eligibility criteria are included in this
document. The final eligibility criteria guidelines document is also
available at https://www.livingdonorassistancecenter.gov.
National Living Donor Assistance Center (NLDAC) Program Eligibility
Guidelines
Section 3 of the Organ Donation and Recovery Improvement Act
(ODRIA), 42 U.S.C. 274f, establishes the authority and legislative
parameters to provide reimbursement for travel and subsistence expenses
incurred towards living organ donation. HRSA awarded a cooperative
agreement to the Regents of the University of Michigan (Michigan),
which partnered with the American Society of Transplant Surgeons
(ASTS), to establish the National Living Donor Assistance Center
(NLDAC) to operate this Program.
As provided for in the statutory authorization, this Program is
intended to provide reimbursement only in those circumstances when
payment cannot reasonably be covered by other sources of reimbursement.
The NLDAC, under Federal law, cannot provide reimbursement to any
living organ donor for travel and other qualifying expenses if the
donor can receive reimbursement for these expenses from any of the
following sources:
(1) Any State compensation program, an insurance policy, or any
Federal or State health benefits program;
(2) an entity that provides health services on a prepaid basis; or
(3) the recipient of the organ.
In response to public solicitation of comments, a threshold of
income eligibility for the recipient of the organ is 300 percent of the
Department of Health and Human Services (HHS) Poverty Guidelines in
effect at the time of the eligibility determination. The Program
assumes that recipients whose income exceeds this level will have the
ability to reimburse the living organ donor for the travel and
subsistence expenses and any other qualifying expenses that can be
authorized by the Secretary of HHS. The Program provides an exception
to this rule for financial hardships. A transplant social worker, or
appropriate transplant center representative, based on a complete
recipient evaluation, can provide an official statement,
notwithstanding the recipient's income level, that the recipient of the
organ would face significant financial hardship if required to pay for
the qualifying living organ donor expenses. A recipient's financial
hardship is defined as circumstances in which the recipient's income
exceeds 300 percent of the HHS Poverty Guidelines in effect at the time
of the eligibility determination, but the individual will have
difficulty paying the donor's expenses due to other significant
expenses. Whether or not hardship exists in a particular case requires
a fact-specific analysis; examples of significant expenses include
circumstances such as paying for medical expenses not covered by
insurance or providing significant financial support for a family
member not living in the household (e.g., elderly parent). Waiver
requests by the
[[Page 57051]]
transplant center, on behalf of the donor, shall be made in writing and
shall clearly describe the circumstances for the waiver request. The
NLDAC will review waiver requests and make a recommendation to HRSA to
either approve or deny the request. HRSA will make the final
determination and communicate its final determination to the NLDAC. The
NDLAC will notify the transplant center of the final determination.
HRSA's determination will not be subject to appeal.
All persons who wish to become living organ donors are eligible to
receive reimbursement for their travel and qualified expenses if they
cannot receive reimbursement from the sources outlined above and if all
the requirements outlined in the Criteria for Donor Reimbursement
Section are satisfied. However, because of the limited funds available,
prospective living 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 and recipient's income, in relation to the
HHS Poverty Guidelines (described in Table 1.1 below), and (2)
financial hardship. As a general matter, income refers to the donor or
recipient's total household income. A donor may be able to demonstrate
financial hardship, even if the donor's income exceeds 300 percent of
the HHS Poverty Guidelines, if the donor will have difficulty paying
the qualifying expenses due to other significant expenses. Although all
requests will be reviewed on a case-by-case basis, examples of
significant expenses include circumstances such as providing
significant financial support for a family member not living in the
household (e.g., elderly parent), loss of income due to donation
process. Waiver requests by the transplant center, on behalf of the
donor, shall be made in writing and shall clearly describe the
circumstances for the waiver request. The NLDAC will review waiver
requests and make a recommendation to HRSA to either approve or deny
the request. HRSA will make the final determination and communicate its
final determination to the NLDAC. The NLDAC will notify the transplant
center of the final determination. HRSA's determination will not be
subject to appeal.
Donors will be given preference in the following order of priority:
Preference Category 1: The donor's income and the recipient's
income are each 300 percent or less of HHS Poverty Guidelines in effect
at the time of the eligibility determination in their respective states
of primary residence.
Preference Category 2: Although the donor's income exceeds 300
percent of the HHS Poverty Guidelines in effect in the State of primary
residence at the time of the eligibility determination, the donor
demonstrates financial hardship. The recipient's income is at or below
300 percent of the HHS Poverty Guidelines in effect in the State of
primary residence at the time of the eligibility determination.
Preference Category 3: Any living organ donor, regardless of income
or financial hardship, if the recipient's income is at or below 300
percent of the HHS Poverty Guidelines in effect in the recipient's
State of primary residence at the time of the eligibility
determination.
Preference Category 4: Any living organ donor, regardless of income
or financial hardship, if the recipient (with income above 300 percent
of the HHS Poverty Guidelines in effect in the State of primary
residence at the time of the eligibility determination) demonstrates
financial hardship.
HRSA reserves the right to prioritize those most in financial need
(based on income or other specified factors) if it receives large
numbers of applications concerning donors meeting preference category
1.
The HHS Poverty Guidelines for 2007 (Federal Register, Vol. 72, No.
15, January 24, 2007, pp. 3147-3148) are shown in the table below.
2007 HHS Poverty Guidelines
----------------------------------------------------------------------------------------------------------------
48 Contiguous
Persons in family or household States and DC Alaska Hawaii
----------------------------------------------------------------------------------------------------------------
1...................................................... $10,210 $12,770 $11,750
2...................................................... 13,690 17,120 15,750
3...................................................... 17,170 21,470 19,750
4...................................................... 20,650 25,820 23,750
5...................................................... 24,130 30,170 27,750
6...................................................... 27,610 34,520 31,750
7...................................................... 31,090 38,870 35,750
8...................................................... 34,570 43,220 39,750
For each additional person, add........................ 3,480 4,350 4,000
----------------------------------------------------------------------------------------------------------------
Source: Federal Register, Vol. 72, No. 15, January 24, 2007, pp. 3147-3148.
These guidelines are updated periodically.
Criteria for Donor Reimbursement
1. Any individual who in good faith incurs travel and other
qualifying expenses toward the intended donation of an organ.
2. Donor and recipient of the organ are U.S. citizens or lawfully
admitted residents of the U.S.
3. Donor and recipient have primary residences in the U.S. or its
territories.
4. Travel is originating from the donor's primary residence.
5. Donor and recipient certify that they understand and are in
compliance with Section 301 of NOTA (42 U.S.C. 274e) which states in
part ``* * * 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.''
6. The transplant center where the donation procedure occurs
certifies to its status of good standing with the Organ Procurement and
Transplantation Network (OPTN).
Qualifying Expenses
For the purposes of the Reimbursement of Travel and Subsistence
Expenses toward Living Organ Donation Program, qualifying expenses
presently include only travel, lodging, and meals and incidental
expenses incurred by the donor and/or his/her accompanying person(s) as
part of:
(1) Donor evaluation, clinic visit or hospitalization,
(2) Hospitalization for the living donor surgical procedure, and/or
[[Page 57052]]
(3) Medical or surgical follow-up clinic visit or hospitalization
within 90 days following the living donation procedure.
The Program will pay for a total of up to five trips; three for the
donor and two for accompanying persons. The accompanying persons need
not be the same each trip.
The total Federal reimbursement for qualified expenses during the
donation process for the donor and accompanying individuals shall not
exceed $6,000.00. Reimbursement for qualifying expenses 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.
For donor and recipient pairs participating in a paired exchange
program, the applicable eligibility criteria for the originally
intended recipient shall be considered for the purpose of reimbursement
of qualifying donor expenses even though the final recipient of the
donated organ may not be the recipient identified in the original
donor-recipient pair.
Maximum Number of Prospective Donors per Recipient
Kidney: One donor at a time with a maximum of three
donors.
Liver: One donor at a time with a maximum of five donors.
Lung: Two donors at a time with a maximum of six donors.
Special Provisions
Many factors may prevent the intended and willing donor from
proceeding with the donation. Circumstances that would prevent the
transplant or donation from proceeding include: Present health status
of the intended donor or recipient, perceived long-term risks to the
intended donor, justified circumstances such as acts of God (e.g.,
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 NLDAC, but then elects not to pursue donation. In
such cases, the intended donor and accompanying persons may receive
reimbursement for qualified expenses incurred as if the donation had
been completed. Under Program policy, a form will be filed with the
Internal Revenue Service (IRS) reporting funds disbursed as income for
expenses not incurred.
Dated: October 1, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7-19747 Filed 10-4-07; 8:45 am]
BILLING CODE 4165-15-P
