[Federal Register Volume 74, Number 117 (Friday, June 19, 2009)]
[Notices]
[Pages 29218-29220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14425]


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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 (HRSA), HHS.

ACTION: Response to solicitation of comments on amendment to program 
follow-up period and publication of amended Program Eligibility 
Guidelines.

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SUMMARY: This notice finalizes an amendment to the eligibility 
guidelines proposed on March 4, 2009 in the Federal Register (74 FR 
9407). 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 
follow-up period.

FOR FURTHER INFORMATION CONTACT: Richard Durbin, 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: [email protected].

SUPPLEMENTARY INFORMATION: In the existing Program eligibility 
guidelines, under the Qualifying Expenses Section, the first paragraph 
states:

    ``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.''

HRSA proposed amending the first bullet of this paragraph to read: 
``(1) Donor evaluation, and/or''. In addition, HRSA proposed amending 
the third bullet of this paragraph to read: ``(3) Medical or surgical 
follow-up clinic visit or hospitalization within two calendar years or 
beyond--if exceptional circumstances exist--following the living 
donation procedure.'' The purpose of this proposed change was to bring 
the NLDAC follow-up period in line with the OPTN policies of a 2-year 
follow-up of living organ donors.
    HRSA received six public comments on this request. All the 
respondents

[[Page 29219]]

support HRSA's proposed amendment. HRSA wishes to thank everyone who 
reviewed this request even if a formal response was not sent to HRSA.
    Through this notice, HRSA approves the amendment to the 
Reimbursement of Travel and Subsistence Expenses Program Eligibility 
Guidelines as published in the Federal Register. This document also 
corrects a mistake included in the previous version of the Guidelines 
concerning the proper decision-maker on financial hardship 
determinations. Finally, HRSA notes that the grantee has the authority 
to make operational decisions in implementing the Program, such as 
setting filing deadlines.
    The amended eligibility criteria are included in this document. The 
amended eligibility criteria guidelines document is also available at 
http://www.livingdonorassistance.org.

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). 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 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 NDLAC 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 for the grantee 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 2009 (Federal Register, Vol. 74, No. 
14,

[[Page 29220]]

January 23, 2009, pp. 4199-4201) are shown in the table below.

                                           2009 HHS Poverty Guidelines
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                                                                   48 Contiguous
                 Persons in family or household                    States and DC      Alaska          Hawaii
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1...............................................................         $10,830         $13,530         $12,460
2...............................................................          14,570          18,210          16,760
3...............................................................          18,310          22,890          21,060
4...............................................................          22,050          27,570          25,360
5...............................................................          25,790          32,250          29,660
6...............................................................          29,530          36,930          33,960
7...............................................................          33,270          41,610          38,260
8...............................................................          37,010          46,290          42,560
For each additional person, add.................................           3,740           4,680           4,300
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Source: Federal Register, Vol. 74, No. 14, January 23, 2009, pp. 4199-4201.

    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 and/or
    (2) Hospitalization for the living donor surgical procedure, and/or
    (3) Medical or surgical follow-up, clinic visits, or 
hospitalization within 2 calendar years following the living donation 
procedure (or beyond the 2-year period if exceptional circumstances 
exist).
    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 10, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9-14425 Filed 6-18-09; 8:45 am]
BILLING CODE 4165-15-P