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###### Department of Health and Human Services

###### Health Resources and Services Administration

# AGENCY:

Health Resources and Services Administration (HRSA), HHS.

# ACTION:

Request for public comment. 

# 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 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,                               ( print 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                         *mgerman@hrsa.gov.*                         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:                         *jburdick@hrsa.gov.*

# 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:                         *jburdick@hrsa.gov.*

# 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                          ( print 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]

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