[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Notices]
[Pages 873-875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31312]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Extramural Support Reimbursement of Travel and Subsistence 
Expenses Toward Living Organ Donation Program

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Request for Information.

-----------------------------------------------------------------------

SUMMARY: Congress has provided specific authority under section 377 of 
the Public Health Service (PHS) Act, 42 U.S.C. 274f, as amended by 
Public Law 108-216 for providing reimbursement of travel and 
subsistence expenses for certain individuals donating their organs. 
Additionally, Congress authorized the Secretary to provide 
reimbursement for other incidental non-medical expenses as the 
Secretary determines by regulation to be appropriate.
    Accordingly, under the existing Program launched in October 2007, 
individuals who meet Program eligibility guidelines may receive 
reimbursement for qualifying travel and subsistence expenses related to 
live organ donation. The existing Program

[[Page 874]]

structure is based on Section 377(a)(1) of the PHS Act. This section 
explicitly allows the Secretary to provide reimbursement of travel and 
subsistence expenses incurred by living organ donors. HRSA wishes to 
implement Section 377(a)(2) of the PHS Act which authorizes the 
Secretary to issue regulations describing other incidental nonmedical 
expenses appropriate for reimbursement under this Program. The 
Department is considering initiating rulemaking proposing that 
reimbursement be extended to additional expenses incurred by living 
donors as ``incidental nonmedical expenses'' under 42 U.S.C. 
274f(a)(2).
    Before initiating such rulemaking, HRSA is soliciting input from 
the community on specific incidental nonmedical expenses to be 
considered for reimbursement. HRSA is looking for guidance from the 
community on the mechanism(s) to determine the appropriate 
reimbursement amount for these additional expenses and to validate that 
donors incurred or will incur these additional expenses as a result of 
making living donations of their organs. For example, if the community 
thinks lost wages and childcare expenses are incidental nonmedical 
expenses the Program should consider for reimbursement, how much the 
Program should reimburse donors for these expenses and on what basis 
should this determination be made?
    Individuals can send their comments either by mail, fax, or email 
to the Division of Transplantation at the address listed below. In 
addition, the Division plans to sponsor three conference calls to 
discuss the Program.

DATES: To be considered, written comments must be postmarked no later 
than March 22, 2010. The conference calls will be held on Tuesday, 
February 23, 2010 from 10 a.m. to 11:30 a.m.; Wednesday, February 24, 
2010 from 2:30 p.m. to 4 p.m.; and Friday, March 5, 2010 from 1 p.m. to 
2:30 p.m. All listed times are eastern standard times. Participants 
must register for the conference calls by contacting Richard Laeng, 
Public Health Analyst, at (301) 443-5410 or e-mail [email protected]. The 
registration deadline is Thursday, February 18, 2010. Because the same 
information will be discussed on all the calls, it is not necessary to 
register for multiple calls. Registration is not guaranteed; it is on a 
first come basis.

ADDRESSES: Please send all written comments to Mesmin Germain, Public 
Health Analyst, Division of Transplantation, Healthcare Systems Bureau, 
Health Resources and Services Administration, Department of Health and 
Human Services, Room 12C-06, Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland 20857; telephone: (301) 443-0053; fax: (301) 594-
6095; e-mail: [email protected].

FOR FURTHER INFORMATION CONTACT: Mesmin Germain, Public Health Analyst, 
Division of Transplantation, Healthcare Systems Bureau, Health 
Resources and Services Administration, Department of Health and Human 
Services, Room 12C-06, Parklawn Building, 5600 Fishers Lane, Rockville, 
Maryland 20857; telephone: (301) 443-0053; fax: (301) 594-6095; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Background

    On September 14, 2006, HRSA awarded a 4-year cooperative agreement 
to the Regents of the University of Michigan to establish a national 
Program to provide reimbursement to living donors for travel and 
subsistence expenses, as well as additional expenses authorized by any 
future regulations issued by the Secretary. The Regents of the 
University of Michigan in partnership with the American Society of 
Transplant Surgeons (ASTS) established the National Living Donor 
Assistance Center (NLDAC) to operate this national Program.
    On October 17, 2007, The Regents of the University of Michigan and 
ASTS officially launched NLDAC. NLDAC is located at the ASTS 
Headquarter in Arlington, Virginia. NLDAC has officially partnered with 
299 living transplant programs throughout the United States to submit 
applications for reimbursement on behalf of their living donors. 
Applications are filed through the transplant centers and reviewed by a 
committee at NLDAC. Program eligibility is based on donor and recipient 
incomes of 300 percent or less of the HHS Poverty Guidelines. 
Applicants who do not meet eligibility guidelines may request a waiver. 
All waiver requests are reviewed for approval by HRSA. The Program 
provides prospective reimbursement to living donors based on the 
estimated travel expenses related to the donation process. Funds are 
provided through a controlled value card, giving NLDAC the ability to 
add and subtract funds as needed. All expenses are monitored in real 
time by NLDAC to ensure that donors are using funds according to 
Program guidelines.
    HRSA sought input from the public from the conceptual stage of the 
Program through the determination of the Program's final eligibility 
criteria to ensure that the Program addresses the needs of the public:
     On October 13, 2005, HRSA published a Request for Public 
Comments on the proposed Program to provide reimbursement of travel and 
subsistence expenses in the Federal Register (70 FR 59760).
     On April 9, 2007, HRSA published a Request for Public 
Comments concerning the proposed Program eligibility criteria in the 
Federal Register (72 FR 17564).
     On October 5, 2007, HRSA published a Response to 
Solicitation of Comments and Final Program Eligibility Guidelines in 
the Federal Register (72 FR 57049).
     On March 5, 2008, HRSA published a Request for Public 
Comments on proposed changes to the reimbursement of travel and 
subsistence expenses Program eligibility criteria (concerning 
additional follow-up visits for donors) in the Federal Register (73 FR 
11930).
     On June 20, 2008, HRSA published a change to Program 
eligibility guidelines to provide reimbursement for additional follow-
up visits for donors in the Federal Register (73 FR 35143).
     On March 4, 2009, HRSA published a Request for Public 
Comments on a proposed change to the Program eligibility criteria 
(concerning the follow-up period) in the Federal Register (74 FR 9407).
     On June 19, 2009, HRSA published an amendment to Program 
eligibility guidelines to extend follow-up period that donors may 
receive reimbursement for qualifying expenses in the Federal Register 
(74 FR 29218).
    Through September 30, 2009, the Program has facilitated 370 living 
organ transplants. Overall, 697 applications have been approved for 
funding under the established Program eligibility guidelines. The 
average reimbursement per living donor is approximately $2,600.
    HRSA initiated this Program to address the travel and subsistence 
expenses faced by potential donors, recipients, and family alike. Even 
with this support, living donors still face other financial barriers 
related to the donation process.
    Reimbursement of other incidental nonmedical expenses being 
considered would further diminish the financial barriers faced by many 
donors. Reimbursement for the additional expenses would be provided 
while maintaining the existing Program guidelines, including capping 
total reimbursement per donor and companions at $6,000. The expansion 
will be provided under the Qualified

[[Page 875]]

Expenses Section of the Program Eligibility Guidelines.
    Any payment permitted under this authority must not violate section 
301 of the National Organ Transplant Act of 1984, which makes it 
``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.'' 42 
U.S.C. 274e(a). Certain expenses are excluded from the scope of 
valuable consideration, including ``expenses of travel, housing, and 
lost wages incurred by the donor of a human organ in connection with 
the donation of the organ.'' 42 U.S.C. 274e(c)(2). As the Secretary 
considers rulemaking, she will consider this criminal prohibition in 
evaluating which expenses are appropriate for reimbursement under this 
Program.
    HRSA is seeking public comment as to whether the Secretary should 
initiate rulemaking to allow reimbursement under this Program for 
specific incidental nonmedical expenses and concerning which incidental 
nonmedical expenses should be included in such rulemaking.

    Dated: December 29, 2009.
Mary K. Wakefield,
Administrator.
[FR Doc. E9-31312 Filed 1-5-10; 8:45 am]
BILLING CODE 4165-15-P