[Federal Register: June 20, 2008 (Volume 73, Number 120)]
[Notices]
[Page 35143-35145]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn08-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Reimbursement of Travel and Subsistence Expenses Toward Living
Organ Donation Eligibility Guidelines
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Publication of Change to Program Eligibility Guidelines.
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SUMMARY: This notice finalizes an amendment to the eligibility
guidelines proposed on March 5, 2008, in the Federal Register (73 FR
11930). The purpose of this notice was to solicit comments on the
amendment to the Program Eligibility Guidelines proposed by HRSA
concerning the Reimbursement of Travel and Subsistence Expenses
Program.
FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director,
Division of Transplantation, Healthcare Systems Bureau, Health
Resources and Services Administration (HRSA), 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: In its final program eligibility guidelines,
HRSA explained that ``[t]he 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.'' HRSA proposes
amending this paragraph to read: ``[t]he Program will pay for a total
of up to five trips; three for the donor and two for accompanying
persons. However, in cases in which the transplant center requests the
donor to return to the transplant center for additional visits as a
result of donor complications or other health related issues, the
National Living Donor Assistance Center (NLDAC) may provide
reimbursement for the additional visit(s) for the donor and an
accompanying person. The accompanying persons need not be the same in
each trip.'' The purpose of this proposed change is to accommodate
individuals who experience donor complications or other health related
issues relating to donation.
HRSA received one public comment on this request. The respondent
endorses HRSA's proposed amendment because ``it will accommodate
individuals who experience donor complications or other health related
issues relating to donation''. HRSA wishes to thank everyone who
reviewed this request even if a formal response was not sent to HRSA.
HRSA approved the amendment to the Reimbursement of Travel and
Subsistence Expenses Program Eligibility Guidelines as published in the
Federal Register. The amended eligibility criteria are included in this
document. The amended eligibility criteria guidelines document is also
available at http://www.livingdonorassistancecenter.gov.
[[Page 35144]]
National Living Donor Assistance Center (NLDAC) Program Eligibility
Guidelines as Amended
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). Each waiver
request shall be made in writing. The NLDAC will review each written
financial hardship request and (upon consultation with HRSA in
complicated cases) make the determination as to whether reimbursement
will be approved based on the merits of the request.
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 the 2007 HHS Poverty Guidelines
table 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 (upon consultation with HRSA in complicated cases) make
determinations regarding the approval or disapproval of waivers.
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.
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
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48 contiguous
Persons in family or household states and DC Alaska Hawaii
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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
[[Page 35145]]
For each additional person, add.............................. 3,480 4,350 4,000
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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
(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. However, in cases in which the
transplant center requests the donor to return to the transplant center
for additional visits as a result of donor complications or other
health related issues, NLDAC may provide reimbursement for the
additional visit(s) for the donor and an accompanying person. The
accompanying persons need not be the same in 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: June 13, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-14036 Filed 6-19-08; 8:45 am]
BILLING CODE 4165-15-P