I 

108TH CONGRESS 

2D SESSION H. R. 3926

To amend the Public Health Service Act to promote organ donation, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 10, 2004

Mr. BILIRAKIS (for himself, Mr. BROWN of Ohio, Mr. BARTON of Texas, Mr. 

DINGELL, Mr. UPTON, Mr. WAXMAN, Mr. BURR, and Mr. PALLONE) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL

To amend the Public Health Service Act to promote organ 

donation, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Organ Donation and 

5 Recovery Improvement Act’’. 

6 SEC. 2. SENSE OF CONGRESS. 

7 (a) PUBLIC AWARENESS OF NEED FOR ORGAN DO8 NATION.—It is the sense of Congress that the Federal 

9 Government should carry out programs to educate the 
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1 public with respect to organ donation, including the need 

2 to provide for an adequate rate of such donations. 

3 (b) FAMILY DISCUSSIONS OF ORGAN DONATIONS.—

4 Congress recognizes the importance of families pledging 

5 to each other to share their lives as organ and tissue do6 nors and acknowledges the importance of discussing organ 

7 and tissue donation as a family. 

8 (c) LIVING DONATIONS OF ORGANS.—Congress—

9 (1) recognizes the generous contribution made 

10 by each living individual who has donated an organ 

11 to save a life; and 

12 (2) acknowledges the advances in medical tech13 nology that have enabled organ transplantation with 

14 organs donated by living individuals to become a via15 ble treatment option for an increasing number of pa16 tients. 

17 SEC. 3. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE 

18 EXPENSES INCURRED TOWARD LIVING 

19 ORGAN DONATION. 

20 Section 377 of the Public Health Service Act (42 

21 U.S.C. 274f) is amended to read as follows: 
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1 ‘‘SEC. 377. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE 

2 EXPENSES INCURRED TOWARD LIVING 

3 ORGAN DONATION. 

4 ‘‘(a) IN GENERAL.—The Secretary may award grants 

5 to States, transplant centers, qualified organ procurement 

6 organizations under section 371, or other public or private 

7 entities for the purpose of—

8 ‘‘(1) providing for the reimbursement of travel 

9 and subsistence expenses incurred by individuals to10 ward making living donations of their organs (in this 

11 section referred to as ‘donating individuals’); and 

12 ‘‘(2) providing for the reimbursement of such 

13 incidental nonmedical expenses that are so incurred 

14 as the Secretary determines by regulation to be ap15 propriate. 

16 ‘‘(b) PREFERENCE.—The Secretary shall, in carrying 

17 out subsection (a), give preference to those individuals 

18 that the Secretary determines are more likely to be other19 wise unable to meet such expenses. 

20 ‘‘(c) CERTAIN CIRCUMSTANCES.—The Secretary 

21 may, in carrying out subsection (a), consider—

22 ‘‘(1) the term ‘donating individuals’ as includ23 ing individuals who in good faith incur qualifying ex24 penses toward the intended donation of an organ but 

25 with respect to whom, for such reasons as the Sec-
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1 retary determines to be appropriate, no donation of 

2 the organ occurs; and 

3 ‘‘(2) the term ‘qualifying expenses’ as including 

4 the expenses of having relatives or other individuals, 

5 not to exceed 2, accompany or assist the donating 

6 individual for purposes of subsection (a) (subject to 

7 making payment for only those types of expenses 

8 that are paid for a donating individual). 

9 ‘‘(d) RELATIONSHIP TO PAYMENTS UNDER OTHER

10 PROGRAMS.—An award may be made under subsection (a) 

11 only if the applicant involved agrees that the award will 

12 not be expended to pay the qualifying expenses of a donat13 ing individual to the extent that payment has been made, 

14 or can reasonably be expected to be made, with respect 

15 to such expenses—

16 ‘‘(1) under any State compensation program, 

17 under an insurance policy, or under any Federal or 

18 State health benefits program; 

19 ‘‘(2) by an entity that provides health services 

20 on a prepaid basis; or 

21 ‘‘(3) by the recipient of the organ. 

22 ‘‘(e) DEFINITIONS.—For purposes of this section: 

23 ‘‘(1) The term ‘donating individuals’ has the 

24 meaning indicated for such term in subsection 

25 (a)(1), subject to subsection (c)(1). 
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1 ‘‘(2) The term ‘qualifying expenses’ means the 

2 expenses authorized for purposes of subsection (a), 

3 subject to subsection (c)(2). 

4 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 

5 purpose of carrying out this section, there is authorized 

6 to be appropriated $5,000,000 for each of the fiscal years 

7 2005 through 2009.’’. 

8 SEC. 4. PUBLIC AWARENESS; STUDIES AND DEMONSTRA9 TIONS. 

10 Part H of title III of the Public Health Service Act 

11 (42 U.S.C. 273 et seq.) is amended by inserting after sec12 tion 377 the following: 

13 ‘‘SEC. 377A. PUBLIC AWARENESS; STUDIES AND DEM14 ONSTRATIONS. 

15 ‘‘(a) ORGAN DONATION PUBLIC AWARENESS PRO16 GRAM.—The Secretary shall, directly or through grants or 

17 contracts, establish a public education program in co18 operation with existing national public awareness cam19 paigns to increase awareness about organ donation and 

20 the need to provide for an adequate rate of such donations. 

21 ‘‘(b) STUDIES AND DEMONSTRATIONS.—The Sec22 retary may make peer-reviewed grants to, or enter into 

23 peer-reviewed contracts with, public and nonprofit private 

24 entities for the purpose of carrying out studies and dem-
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1 onstration projects to increase organ donation and recov2 ery rates, including living donation. 

3 ‘‘(c) GRANTS TO STATES.—

4 ‘‘(1) IN GENERAL.—The Secretary may make 

5 grants to States for the purpose of assisting States 

6 in carrying out organ donor awareness, public edu7 cation, and outreach activities and programs de8 signed to increase the number of organ donors with9 in the State, including living donors. 

10 ‘‘(2) ELIGIBILITY.—To be eligible to receive a 

11 grant under this subsection, a State shall—

12 ‘‘(A) submit an application to the Depart13 ment in the form prescribed; 

14 ‘‘(B) establish yearly benchmarks for im15 provement in organ donation rates in the State; 

16 and 

17 ‘‘(C) report to the Secretary on an annual 

18 basis a description and assessment of the 

19 State’s use of funds received under this sub20 section, accompanied by an assessment of ini21 tiatives for potential replication in other States. 

22 ‘‘(3) USE OF FUNDS.—Funds received under 

23 this subsection may be used by the State, or in part24 nership with other public agencies or private sector 

25 institutions, for education and awareness efforts, in-
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1 formation dissemination, activities pertaining to the 

2 State donor registry, and other innovative donation 

3 specific initiatives, including living donation. 

4 ‘‘(d) EDUCATIONAL ACTIVITIES.—The Secretary, in 

5 coordination with the Organ Procurement and Transplan6 tation Network and other appropriate organizations, shall 

7 support the development and dissemination of educational 

8 materials to inform health care professionals and other ap9 propriate professionals in issues surrounding organ, tis10 sue, and eye donation including evidence-based proven 

11 methods to approach patients and their families, cultural 

12 sensitivities, and other relevant issues. 

13 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 

14 purpose of carrying out this section, there are authorized 

15 to be appropriated $15,000,000 for fiscal year 2005, and 

16 such sums as may be necessary for each of the fiscal years 

17 2006 through 2009. Such authorization of appropriations 

18 is in addition to any other authorizations of appropriations 

19 that are available for such purpose. 

20 ‘‘SEC. 377B. GRANTS REGARDING HOSPITAL ORGAN DONA21 TION COORDINATORS. 

22 ‘‘(a) AUTHORITY.—

23 ‘‘(1) IN GENERAL.—The Secretary may award 

24 grants to qualified organ procurement organizations 

25 and hospitals under section 371 to establish pro-
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1 grams coordinating organ donation activities of eligi2 ble hospitals and qualified organ procurement orga3 nizations under section 371. Such activities shall be 

4 coordinated to increase the rate of organ donations 

5 for such hospitals. 

6 ‘‘(2) ELIGIBLE HOSPITAL.—For purposes of 

7 this section, the term ‘eligible hospital’ means a hos8 pital that performs significant trauma care, or a 

9 hospital or consortium of hospitals that serves a 

10 population base of not fewer than 200,000 individ11 uals. 

12 ‘‘(b) ADMINISTRATION OF COORDINATION PRO13 GRAM.—A condition for the receipt of a grant under sub14 section (a) is that the applicant involved agree that the 

15 program under such subsection will be carried out joint16 ly—

17 ‘‘(1) by representatives from the eligible hos18 pital and the qualified organ procurement organiza19 tion with respect to which the grant is made; and 

20 ‘‘(2) by such other entities as the representa21 tives referred to in paragraph (1) may designate. 

22 ‘‘(c) REQUIREMENTS.—Each entity receiving a grant 

23 under subsection (a) shall—
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1 ‘‘(1) establish joint organ procurement organi2 zation and hospital designated leadership responsi3 bility and accountability for the project; 

4 ‘‘(2) develop mutually agreed upon overall 

5 project performance goals and outcome measures, 

6 including interim outcome targets; and 

7 ‘‘(3) collaboratively design and implement an 

8 appropriate data collection process to provide ongo9 ing feedback to hospital and organ procurement or10 ganization leadership on project progress and re11 sults. 

12 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec13 tion shall be construed to interfere with regulations in 

14 force on the date of enactment of the Organ Donation and 

15 Recovery Improvement Act. 

16 ‘‘(e) EVALUATIONS.—Within 3 years after the award 

17 of grants under this section, the Secretary shall ensure 

18 an evaluation of programs carried out pursuant to sub19 section (a) in order to determine the extent to which the 

20 programs have increased the rate of organ donation for 

21 the eligible hospitals involved. 

22 ‘‘(f) MATCHING REQUIREMENT.—The Secretary may 

23 not award a grant to a qualifying organ donation entity 

24 under this section unless such entity agrees that, with re25 spect to costs to be incurred by the entity in carrying out 
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1 activities for which the grant was awarded, the entity shall 

2 contribute (directly or through donations from public or 

3 private entities) non-Federal contributions in cash or in 

4 kind, in an amount equal to not less than 30 percent of 

5 the amount of the grant awarded to such entity. 

6 ‘‘(g) FUNDING.—For the purpose of carrying out this 

7 section, there are authorized to be appropriated 

8 $3,000,000 for fiscal year 2005, and such sums as may 

9 be necessary for each of fiscal years 2006 through 2009.’’. 

10 SEC. 5. STUDIES RELATING TO ORGAN DONATION AND THE 

11 RECOVERY, PRESERVATION, AND TRANSPOR12 TATION OF ORGANS. 

13 Part H of title III of the Public Health Service Act 

14 (42 U.S.C. 273 et seq.) is amended by inserting after sec15 tion 377B, as added by section 4, the following: 

16 ‘‘SEC. 377C. STUDIES RELATING TO ORGAN DONATION AND 

17 THE RECOVERY, PRESERVATION, AND TRANS18 PORTATION OF ORGANS. 

19 ‘‘(a) DEVELOPMENT OF SUPPORTIVE INFORMA20 TION.—The Secretary, acting through the Director of the 

21 Agency for Healthcare Research and Quality, shall develop 

22 scientific evidence in support of efforts to increase organ 

23 donation and improve the recovery, preservation, and 

24 transportation of organs. 
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1 ‘‘(b) ACTIVITIES.—In carrying out subsection (a), the 

2 Secretary shall—

3 ‘‘(1) conduct or support evaluation research to 

4 determine whether interventions, technologies, or 

5 other activities improve the effectiveness, efficiency, 

6 or quality of existing organ donation practice; 

7 ‘‘(2) undertake or support periodic reviews of 

8 the scientific literature to assist efforts of profes9 sional societies to ensure that the clinical practice 

10 guidelines that they develop reflect the latest sci11 entific findings; 

12 ‘‘(3) ensure that scientific evidence of the re13 search and other activities undertaken under this 

14 section is readily accessible by the organ procure15 ment workforce; and 

16 ‘‘(4) work in coordination with the appropriate 

17 professional societies as well as the Organ Procure18 ment and Transplantation Network and other organ 

19 procurement and transplantation organizations to 

20 develop evidence and promote the adoption of such 

21 proven practices. 

22 ‘‘(c) RESEARCH AND DISSEMINATION.—The Sec23 retary, acting through the Director of the Agency for 

24 Healthcare Research and Quality, as appropriate, shall 
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1 provide support for research and dissemination of find2 ings, to—

3 ‘‘(1) develop a uniform clinical vocabulary for 

4 organ recovery; 

5 ‘‘(2) apply information technology and tele6 communications to support the clinical operations of 

7 organ procurement organizations; 

8 ‘‘(3) enhance the skill levels of the organ pro9 curement workforce in undertaking quality improve10 ment activities; and 

11 ‘‘(4) assess specific organ recovery, preserva12 tion, and transportation technologies. 

13 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the 

14 purpose of carrying out this section, there are authorized 

15 to be appropriated $2,000,000 for fiscal year 2005, and 

16 such sums as may be necessary for each of fiscal years 

17 2006 through 2009.’’. 

18 SEC. 6. REPORT RELATING TO ORGAN DONATION AND THE 

19 RECOVERY, PRESERVATION, AND TRANSPOR20 TATION OF ORGANS. 

21 Part H of title III of the Public Health Service Act 

22 (42 U.S.C. 273 et seq.) is amended by inserting after sec23 tion 377C, as added by section 5, the following: 
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1 ‘‘SEC. 377D. REPORT RELATING TO ORGAN DONATION AND 

2 THE RECOVERY, PRESERVATION, AND TRANS3 PORTATION OF ORGANS. 

4 ‘‘(a) IN GENERAL.—Not later than December 31, 

5 2005, and every 2 years thereafter, the Secretary shall re6 port to the appropriate committees of Congress on the ac7 tivities of the Department carried out pursuant to this 

8 part, including an evaluation describing the extent to 

9 which the activities have affected the rate of organ dona10 tion and recovery. 

11 ‘‘(b) REQUIREMENTS.—To the extent practicable, 

12 each report submitted under subsection (a) shall—

13 ‘‘(1) evaluate the effectiveness of activities, 

14 identify effective activities, and disseminate such 

15 findings with respect to organ donation and recov16 ery; 

17 ‘‘(2) assess organ donation and recovery activi18 ties that are recently completed, ongoing, or 

19 planned; and 

20 ‘‘(3) evaluate progress on the implementation of 

21 the plan required under subsection (c)(5). 

22 ‘‘(c) INITIAL REPORT REQUIREMENTS.—The initial 

23 report under subsection (a) shall include the following: 

24 ‘‘(1) An evaluation of the organ donation prac25 tices of organ procurement organizations, States, 

26 other countries, and other appropriate organizations 
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1 including an examination across all populations, in2 cluding those with low organ donation rates, of—

3 ‘‘(A) existing barriers to organ donation; 

4 and 

5 ‘‘(B) the most effective donation and re6 covery practices. 

7 ‘‘(2) An evaluation of living donation practices 

8 and procedures. Such evaluation shall include an as9 sessment of issues relating to informed consent and 

10 the health risks associated with living donation (in11 cluding possible reduction of long-term effects). 

12 ‘‘(3) An evaluation of—

13 ‘‘(A) federally supported or conducted 

14 organ donation efforts and policies, as well as 

15 federally supported or conducted basic, clinical, 

16 and health services research (including research 

17 on preservation techniques and organ rejection 

18 and compatibility); and 

19 ‘‘(B) the coordination of such efforts 

20 across relevant agencies within the Department 

21 and throughout the Federal Government. 

22 ‘‘(4) An evaluation of the costs and benefits of 

23 State donor registries, including the status of exist24 ing State donor registries, the effect of State donor 

25 registries on organ donation rates, issues relating to 
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1 consent, and recommendations regarding improving 

2 the effectiveness of State donor registries in increas3 ing overall organ donation rates. 

4 ‘‘(5) A plan to improve federally supported or 

5 conducted organ donation and recovery activities, in6 cluding, when appropriate, the establishment of 

7 baselines and benchmarks to measure overall out8 comes of these programs. Such plan shall provide for 

9 the ongoing coordination of federally supported or 

10 conducted organ donation and research activities.’’. 

11 SEC. 7. NATIONAL LIVING DONOR MECHANISMS. 

12 Part H of title III of the Public Health Service Act 

13 (42 U.S.C. 273 et seq.) is amended by inserting after sec14 tion 371 the following: 

15 ‘‘SEC. 371A. NATIONAL LIVING DONOR MECHANISMS. 

16 ‘‘The Secretary may establish and maintain mecha17 nisms to evaluate the long-term effects associated with liv18 ing organ donations by individuals who have served as liv19 ing donors.’’. 

20 SEC. 8. STUDY. 

21 Not later than December 31, 2004, the Secretary of 

22 Health and Human Services, in consultation with appro23 priate entities, including advocacy groups representing 

24 those populations that are likely to be disproportionately 

25 affected by proposals to increase cadaveric donation, shall 
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1 submit to the appropriate committees of Congress a report 

2 that evaluates the ethical implications of such proposals. 

3 SEC. 9. QUALIFIED ORGAN PROCUREMENT ORGANIZA4 TIONS. 

5 Section 371(a) of the Public Health Service Act (42 

6 U.S.C. 273(a)) is amended by striking paragraph (3).

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