[Federal Register Volume 73, Number 120 (Friday, June 20, 2008)]
[Notices]
[Pages 35143-35145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14036]


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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: [email protected].

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