[Federal Register Volume 72, Number 193 (Friday, October 5, 2007)]
[Notices]
[Pages 57049-57052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19747]


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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 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.

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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: [email protected].

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 http://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
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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
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

[[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