[Federal Register Volume 70, Number 197 (Thursday, October 13, 2005)]
[Notices]
[Pages 59760-59762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20456]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Extramural Support Program for Reimbursement of Travel and 
Subsistence Expenses Incurred Toward Living Organ Donations

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Request for public comment.

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SUMMARY: Congress has provided specific authority under section 377 of 
the Public Health Service (PHS) Act, 42 U.S.C. Sec.  274f, as amended 
by Public Law 108-216 for providing reimbursement of travel and 
subsistence expenses for certain individuals donating their organs. 
Additionally, Congress has provided the Secretary the authority to 
provide reimbursement for other incidental non-medical expenses as the 
Secretary determines by regulation to be appropriate. The Health 
Resources and Services Administration is developing a demonstration 
program to fulfill this authority. In the first cycle,

[[Page 59761]]

the program will focus exclusively on providing reimbursement of travel 
and subsistence expenses for certain individuals donating their organs. 
In the future, the program may provide reimbursement for other 
incidental non-medical expense. The purpose of this solicitation of 
comments is to assist HRSA in establishing an effective program which 
addresses the concerns and the needs of the community. In addition, the 
Division of Transplantation, Healthcare Systems Bureau plans two 
conference calls to discuss the program.

DATES: The conference calls will be held on October 19, 2005, at 1 p.m. 
to 3 p.m. e.s.t. and October 25, 2005, at 10 a.m. to 12 p.m. e.s.t. 
Participants are asked to register for the conference calls by 
contacting Mesmin German at (301) 443-0053 or e-mail [email protected]. 
The registration deadline is October 12, 2005, for the October 19, 
2005, conference call and October 20, 2005, for the October 25, 2005, 
conference call. Since similar information will be discussed on both 
calls, it is not necessary to register for both. Registration is not 
guaranteed; it is on a first come basis. To be considered, written 
comments should be postmarked no later than November 4, 2005.

ADDRESSES: Please send all written comments to James F. Burdick, M.D., 
Director, Division of Transplantation, Healthcare Systems Bureau, 
Health Resources and Services Administration, Room 12C-06, Parklawn 
Building, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 
443-7577; fax (301) 594-6095; or e-mail: [email protected].

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, DOT, 
HSB, 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:

Solicitation of Comments

    The Health Resources and Services Administration's (HRSA) 
Healthcare Systems Bureau (HSB), Division of Transplantation (DoT), is 
soliciting input from the community on the following: (1) The general 
structure and processes of the proposed program to account for 
geographic variations; (2) criteria for the Secretary to use in 
determining individuals who are more likely to be otherwise unable to 
meet such expenses; and (3) the reasonableness of the level of 
reimbursement to be made available per living donor and accompanying 
persons. HRSA is also soliciting input on what other incidental non-
medal expenses may be covered under this program. Moreover, HRSA is 
seeking input on what the Secretary should consider when drafting 
regulations for reimbursement for other non-medical expenses.

Background

    The number of patients waiting for transplants exceeds 89,000. In 
2004, fewer than 26,000 Americans received transplants and 6,271 died 
waiting. The dire shortage of organs for transplantation has been the 
impetus for the development of protocols intended to expand the donor 
pool, including the use of more than 7,000 organs from living donors in 
2004. Living donors have provided life-saving treatment for many 
individuals with conditions leading to life-threatening end-stage organ 
failure. In addition, in 2003 the number of living donors in the United 
States exceeded the number of deceased donors for the first time.
    Potential living donors, recipients, and family alike face many 
challenges. Even though surgical costs are covered by recipient 
insurance, other costs associated with being a living organ donor can 
represent a substantial financial burden on the parties involved. 
Medically appropriate living donor transplantations can be impossible 
for some individuals because of prohibitive related subsistence 
expenses. Individuals wishing to donate an organ may not be able to 
afford travel, subsistence, and other incidental non-medical costs 
associated with the donation.
    Congress has given the Department of Health and Human Services 
(HHS) the authority to provide limited financial assistance for 
reimbursement of travel and subsistence expenses incurred by the 
donating individuals when appropriate. HRSA, therefore, plans to 
initiate the demonstration program discussed herein. Congress also 
provided the Secretary the authority to provide reimbursement for other 
incidental non-medical expenses as the Secretary determines by 
regulations to be appropriate. Therefore, the type of expenses 
considered under this program may expand in the future.
    The primary goal of this demonstration program is to assist one 
eligible entity in the implementation of an equitable, effective, and 
efficient national program to provide financial assistance to 
individuals who are serving as living organ donors but are unable to 
meet such expenses. Secondary goals of this demonstration program 
include: identifying the medical and non-medical benefits and risks of 
reimbursement for such expenses to donating individuals and recipients 
alike; assessing the impact of this program on the number of living 
donors; and assessing the impact on access to living donation by 
recipients of lower socio-economic status.

Funding

    HRSA expects to award $2 million under this program to support the 
first year of a 3-year demonstration program. Subsequent years of 
funding depend on the availability of appropriations, program 
priorities, and awardees performance.

Program Authority

    Below is the program authority pursuant to Public Law 108-216, the 
Organ Donation and Recovery Improvement Act:

Sec. 3. Reimbursement of Travel and Subsistence Expenses Incurred 
Toward Living Organ Donation

    Section 377 of the Public Health Service Act (42 U.S.C. 274f) is 
amended to read as follows:

Sec. 377. Reimbursement of Travel and Subsistence Expenses Incurred 
Toward Living Organ Donation

    (a) In General--The Secretary may award grants to States, 
transplant centers, qualified organ procurement organizations under 
section 371, or other public or private entities for the purpose of--
    (1) Providing for reimbursement of travel and subsistence expenses 
incurred by individuals toward making living donations of their organs 
(in this section referred to as ``donating individuals''); and
    (2) Providing for the reimbursement of such incidental non-medical 
expenses that are so incurred as the Secretary determines by regulation 
to be appropriate.
    (b) Preference--The Secretary shall, in carrying out subsection 
(a), give preference to those individuals that the Secretary determines 
are more likely to be otherwise unable to meet such expenses.
    (c) Certain Circumstances--The Secretary may, in carrying out 
subsection (a), consider--
    (1) The term ``donating individuals'' as including individuals who 
in good faith incur qualifying expenses toward the intended donation of 
an organ but with respect to whom, for such reasons as the Secretary 
determines to be appropriate, no donation of the organ occurs; and

[[Page 59762]]

    (2) The term ``qualifying expenses'' as including the expenses of 
having relatives or other individuals, not to exceed 2, who accompany 
or assist the donating individual for purposes of subsection (a) 
(subject to making payment for only those types of expenses that are 
paid for a donating individual).
    (d) Relationship to Payments Under Other Programs--An award may be 
made under subsection (a) only if the applicant involved agrees that 
the award will not be expended to pay the qualifying expenses of a 
donating individual to the extent that payment has been made, or can 
reasonably be expected to be made, with respect to such expenses--
    (1) Under any State compensation program, under an insurance 
policy, or under any Federal or State health benefits program;
    (2) By an entity that provides health services on a prepaid basis; 
or
    (3) By the recipient of the organ.
    (e) Definitions--For purposes of this section:
    (1) The term ``donating individuals'' has the meaning indicated for 
such term in subsection (a)(1), subject to subsection (c)(1).
    (2) The term ``qualifying expenses'' means the expenses authorized 
for purposes of subsection (a), subject to subsection (c)(2).
    (f) Authorization of Appropriations--For the purpose of carrying 
out this section, there is authorized to be appropriated $5,000,000 for 
each of the fiscal years 2005 through 2009.

    Dated: October 5, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05-20456 Filed 10-12-05; 8:45 am]
BILLING CODE 4165-15-P