II 

108TH CONGRESS 

2D SESSION H. R. 3926

IN THE SENATE OF THE UNITED STATES 

MARCH 25, 2004

Received 

AN ACT

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,
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1 SECTION 1. SHORT TITLE. 

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

3 Recovery Improvement Act’’. 

4 SEC. 2. SENSE OF CONGRESS. 

5 (a) PUBLIC AWARENESS OF NEED FOR ORGAN DO6 NATION.—It is the sense of Congress that the Federal 

7 Government should carry out programs to educate the 

8 public with respect to organ donation, including the need 

9 to provide for an adequate rate of such donations. 

10 (b) FAMILY DISCUSSIONS OF ORGAN DONATIONS.—

11 Congress recognizes the importance of families pledging 

12 to each other to share their lives as organ and tissue do13 nors and acknowledges the importance of discussing organ 

14 and tissue donation as a family. 

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

16 (1) recognizes the generous contribution made 

17 by each living individual who has donated an organ 

18 to save a life; and 

19 (2) acknowledges the advances in medical tech20 nology that have enabled organ transplantation with 

21 organs donated by living individuals to become a via22 ble treatment option for an increasing number of pa23 tients. 
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1 SEC. 3. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE 

2 EXPENSES INCURRED TOWARD LIVING 

3 ORGAN DONATION. 

4 Section 377 of the Public Health Service Act (42 

5 U.S.C. 274f) is amended to read as follows: 

6 ‘‘SEC. 377. REIMBURSEMENT OF TRAVEL AND SUBSISTENCE 

7 EXPENSES INCURRED TOWARD LIVING 

8 ORGAN DONATION. 

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

10 to States, transplant centers, qualified organ procurement 

11 organizations under section 371, or other public or private 

12 entities for the purpose of—

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

14 and subsistence expenses incurred by individuals to15 ward making living donations of their organs (in this 

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

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

18 incidental nonmedical expenses that are so incurred 

19 as the Secretary determines by regulation to be ap20 propriate. 

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

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

23 that the Secretary determines are more likely to be other24 wise unable to meet such expenses. 

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

26 may, in carrying out subsection (a), consider—
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1 ‘‘(1) the term ‘donating individuals’ as includ2 ing individuals who in good faith incur qualifying ex3 penses toward the intended donation of an organ but 

4 with respect to whom, for such reasons as the Sec5 retary determines to be appropriate, no donation of 

6 the organ occurs; and 

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

8 the expenses of having relatives or other individuals, 

9 not to exceed 2, accompany or assist the donating 

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

11 making payment for only those types of expenses 

12 that are paid for a donating individual). 

13 ‘‘(d) RELATIONSHIP TO PAYMENTS UNDER OTHER

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

15 only if the applicant involved agrees that the award will 

16 not be expended to pay the qualifying expenses of a donat17 ing individual to the extent that payment has been made, 

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

19 to such expenses—

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

21 under an insurance policy, or under any Federal or 

22 State health benefits program; 

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

24 on a prepaid basis; or 

25 ‘‘(3) by the recipient of the organ. 
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1 ‘‘(e) DEFINITIONS.—For purposes of this section: 

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

3 meaning indicated for such term in subsection 

4 (a)(1), subject to subsection (c)(1). 

5 ‘‘(2) The term ‘qualifying expenses’ means the 

6 expenses authorized for purposes of subsection (a), 

7 subject to subsection (c)(2). 

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

9 purpose of carrying out this section, there is authorized 

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

11 2005 through 2009.’’. 

12 SEC. 4. PUBLIC AWARENESS; STUDIES AND DEMONSTRA13 TIONS. 

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

15 (42 U.S.C. 273 et seq.) is amended by inserting after sec16 tion 377 the following: 

17 ‘‘SEC. 377A. PUBLIC AWARENESS; STUDIES AND DEM18 ONSTRATIONS. 

19 ‘‘(a) ORGAN DONATION PUBLIC AWARENESS PRO20 GRAM.—The Secretary shall, directly or through grants or 

21 contracts, establish a public education program in co22 operation with existing national public awareness cam23 paigns to increase awareness about organ donation and 

24 the need to provide for an adequate rate of such donations. 
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1 ‘‘(b) STUDIES AND DEMONSTRATIONS.—The Sec2 retary may make peer-reviewed grants to, or enter into 

3 peer-reviewed contracts with, public and nonprofit private 

4 entities for the purpose of carrying out studies and dem5 onstration projects to increase organ donation and recov6 ery rates, including living donation. 

7 ‘‘(c) GRANTS TO STATES.—

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

9 grants to States for the purpose of assisting States 

10 in carrying out organ donor awareness, public edu11 cation, and outreach activities and programs de12 signed to increase the number of organ donors with13 in the State, including living donors. 

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

15 grant under this subsection, a State shall—

16 ‘‘(A) submit an application to the Depart17 ment in the form prescribed; 

18 ‘‘(B) establish yearly benchmarks for im19 provement in organ donation rates in the State; 

20 and 

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

22 basis a description and assessment of the 

23 State’s use of funds received under this sub24 section, accompanied by an assessment of ini25 tiatives for potential replication in other States. 
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1 ‘‘(3) USE OF FUNDS.—Funds received under 

2 this subsection may be used by the State, or in part3 nership with other public agencies or private sector 

4 institutions, for education and awareness efforts, in5 formation dissemination, activities pertaining to the 

6 State donor registry, and other innovative donation 

7 specific initiatives, including living donation. 

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

9 coordination with the Organ Procurement and Transplan10 tation Network and other appropriate organizations, shall 

11 support the development and dissemination of educational 

12 materials to inform health care professionals and other ap13 propriate professionals in issues surrounding organ, tis14 sue, and eye donation including evidence-based proven 

15 methods to approach patients and their families, cultural 

16 sensitivities, and other relevant issues. 

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

18 purpose of carrying out this section, there are authorized 

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

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

21 2006 through 2009. Such authorization of appropriations 

22 is in addition to any other authorizations of appropriations 

23 that are available for such purpose. 
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1 ‘‘SEC. 377B. GRANTS REGARDING HOSPITAL ORGAN DONA2 TION COORDINATORS. 

3 ‘‘(a) AUTHORITY.—

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

5 grants to qualified organ procurement organizations 

6 and hospitals under section 371 to establish pro7 grams coordinating organ donation activities of eligi8 ble hospitals and qualified organ procurement orga9 nizations under section 371. Such activities shall be 

10 coordinated to increase the rate of organ donations 

11 for such hospitals. 

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

13 this section, the term ‘eligible hospital’ means a hos14 pital that performs significant trauma care, or a 

15 hospital or consortium of hospitals that serves a 

16 population base of not fewer than 200,000 individ17 uals. 

18 ‘‘(b) ADMINISTRATION OF COORDINATION PRO19 GRAM.—A condition for the receipt of a grant under sub20 section (a) is that the applicant involved agree that the 

21 program under such subsection will be carried out joint22 ly—

23 ‘‘(1) by representatives from the eligible hos24 pital and the qualified organ procurement organiza25 tion with respect to which the grant is made; and 
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1 ‘‘(2) by such other entities as the representa2 tives referred to in paragraph (1) may designate. 

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

4 under subsection (a) shall—

5 ‘‘(1) establish joint organ procurement organi6 zation and hospital designated leadership responsi7 bility and accountability for the project; 

8 ‘‘(2) develop mutually agreed upon overall 

9 project performance goals and outcome measures, 

10 including interim outcome targets; and 

11 ‘‘(3) collaboratively design and implement an 

12 appropriate data collection process to provide ongo13 ing feedback to hospital and organ procurement or14 ganization leadership on project progress and re15 sults. 

16 ‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec17 tion shall be construed to interfere with regulations in 

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

19 Recovery Improvement Act. 

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

21 of grants under this section, the Secretary shall ensure 

22 an evaluation of programs carried out pursuant to sub23 section (a) in order to determine the extent to which the 

24 programs have increased the rate of organ donation for 

25 the eligible hospitals involved. 
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1 ‘‘(f) MATCHING REQUIREMENT.—The Secretary may 

2 not award a grant to a qualifying organ donation entity 

3 under this section unless such entity agrees that, with re4 spect to costs to be incurred by the entity in carrying out 

5 activities for which the grant was awarded, the entity shall 

6 contribute (directly or through donations from public or 

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

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

9 the amount of the grant awarded to such entity. 

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

11 section, there are authorized to be appropriated 

12 $3,000,000 for fiscal year 2005, and such sums as may 

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

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

15 RECOVERY, PRESERVATION, AND TRANSPOR16 TATION OF ORGANS. 

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

18 (42 U.S.C. 273 et seq.) is amended by inserting after sec19 tion 377B, as added by section 4, the following: 

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

21 THE RECOVERY, PRESERVATION, AND TRANS22 PORTATION OF ORGANS. 

23 ‘‘(a) DEVELOPMENT OF SUPPORTIVE INFORMA24 TION.—The Secretary, acting through the Director of the 

25 Agency for Healthcare Research and Quality, shall develop 
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1 scientific evidence in support of efforts to increase organ 

2 donation and improve the recovery, preservation, and 

3 transportation of organs. 

4 ‘‘(b) ACTIVITIES.—In carrying out subsection (a), the 

5 Secretary shall—

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

7 determine whether interventions, technologies, or 

8 other activities improve the effectiveness, efficiency, 

9 or quality of existing organ donation practice; 

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

11 the scientific literature to assist efforts of profes12 sional societies to ensure that the clinical practice 

13 guidelines that they develop reflect the latest sci14 entific findings; 

15 ‘‘(3) ensure that scientific evidence of the re16 search and other activities undertaken under this 

17 section is readily accessible by the organ procure18 ment workforce; and 

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

20 professional societies as well as the Organ Procure21 ment and Transplantation Network and other organ 

22 procurement and transplantation organizations to 

23 develop evidence and promote the adoption of such 

24 proven practices. 
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1 ‘‘(c) RESEARCH AND DISSEMINATION.—The Sec2 retary, acting through the Director of the Agency for 

3 Healthcare Research and Quality, as appropriate, shall 

4 provide support for research and dissemination of find5 ings, to—

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

7 organ recovery; 

8 ‘‘(2) apply information technology and tele9 communications to support the clinical operations of 

10 organ procurement organizations; 

11 ‘‘(3) enhance the skill levels of the organ pro12 curement workforce in undertaking quality improve13 ment activities; and 

14 ‘‘(4) assess specific organ recovery, preserva15 tion, and transportation technologies. 

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

17 purpose of carrying out this section, there are authorized 

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

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

20 2006 through 2009.’’. 
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1 SEC. 6. REPORT RELATING TO ORGAN DONATION AND THE 

2 RECOVERY, PRESERVATION, AND TRANSPOR3 TATION OF ORGANS. 

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

5 (42 U.S.C. 273 et seq.) is amended by inserting after sec6 tion 377C, as added by section 5, the following: 

7 ‘‘SEC. 377D. REPORT RELATING TO ORGAN DONATION AND 

8 THE RECOVERY, PRESERVATION, AND TRANS9 PORTATION OF ORGANS. 

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

11 2005, and every 2 years thereafter, the Secretary shall re12 port to the appropriate committees of Congress on the ac13 tivities of the Department carried out pursuant to this 

14 part, including an evaluation describing the extent to 

15 which the activities have affected the rate of organ dona16 tion and recovery. 

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

18 each report submitted under subsection (a) shall—

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

20 identify effective activities, and disseminate such 

21 findings with respect to organ donation and recov22 ery; 

23 ‘‘(2) assess organ donation and recovery activi24 ties that are recently completed, ongoing, or 

25 planned; and 
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1 ‘‘(3) evaluate progress on the implementation of 

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

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

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

5 ‘‘(1) An evaluation of the organ donation prac6 tices of organ procurement organizations, States, 

7 other countries, and other appropriate organizations 

8 including an examination across all populations, in9 cluding those with low organ donation rates, of—

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

11 and 

12 ‘‘(B) the most effective donation and re13 covery practices. 

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

15 and procedures. Such evaluation shall include an as16 sessment of issues relating to informed consent and 

17 the health risks associated with living donation (in18 cluding possible reduction of long-term effects). 

19 ‘‘(3) An evaluation of—

20 ‘‘(A) federally supported or conducted 

21 organ donation efforts and policies, as well as 

22 federally supported or conducted basic, clinical, 

23 and health services research (including research 

24 on preservation techniques and organ rejection 

25 and compatibility); and 
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1 ‘‘(B) the coordination of such efforts 

2 across relevant agencies within the Department 

3 and throughout the Federal Government. 

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

5 State donor registries, including the status of exist6 ing State donor registries, the effect of State donor 

7 registries on organ donation rates, issues relating to 

8 consent, and recommendations regarding improving 

9 the effectiveness of State donor registries in increas10 ing overall organ donation rates. 

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

12 conducted organ donation and recovery activities, in13 cluding, when appropriate, the establishment of 

14 baselines and benchmarks to measure overall out15 comes of these programs. Such plan shall provide for 

16 the ongoing coordination of federally supported or 

17 conducted organ donation and research activities.’’. 

18 SEC. 7. NATIONAL LIVING DONOR MECHANISMS. 

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

20 (42 U.S.C. 273 et seq.) is amended by inserting after sec21 tion 371 the following: 

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

23 ‘‘The Secretary may establish and maintain mecha24 nisms to evaluate the long-term effects associated with liv-
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1 ing organ donations by individuals who have served as liv2 ing donors.’’. 

3 SEC. 8. STUDY. 

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

5 Health and Human Services, in consultation with appro6 priate entities, including advocacy groups representing 

7 those populations that are likely to be disproportionately 

8 affected by proposals to increase cadaveric donation, shall 

9 submit to the appropriate committees of Congress a report 

10 that evaluates the ethical implications of such proposals. 

11 SEC. 9. QUALIFIED ORGAN PROCUREMENT ORGANIZA12 TIONS. 

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

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

Passed the House of Representatives March 24, 

2004. 

Attest: JEFF TRANDAHL, 

Clerk.