To amend the Public Health Service Act to promote organ donation, and for other purposes.

March 6, 2003

Mr. FRIST (for himself, Mr. DODD, and Mr. ENZI) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

To amend the Public Health Service Act to promote organ donation, and for other purposes.

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

SECTION 1. SHORT TITLE.

This Act may be cited as the `Organ Donation and Recovery Improvement Act'.

TITLE I--ORGAN DONATION AND RECOVERY

SEC. 101. INTERAGENCY TASK FORCE ON ORGAN DONATION.

Part H of title III of the Public Health Service Act (42 U.S.C. 273 et seq.) is amended--

(1) by redesignating section 378 (42 U.S.C. 274g) as section 378E; and

(2) by inserting after section 377 (42 U.S.C. 274f) the following:

`SEC. 378. INTER-AGENCY TASK FORCE ON ORGAN DONATION AND RESEARCH.

`(a) IN GENERAL- The Secretary shall establish an inter-agency task force on organ donation and research (referred to in this section as the `task force') to improve the coordination and evaluation of--

`(1) federally supported or conducted organ donation efforts and policies; and

`(2) federally supported or conducted basic, clinical and health services research (including research on preservation techniques and organ rejection and compatibility).

`(b) COMPOSITION-

`(1) IN GENERAL- The task force shall be composed of--

`(A) the Surgeon General, who shall serve as the chairperson; and

`(B) representatives to be appointed by the Secretary from relevant agencies within the Department of Health and Human Services (including the Health Resources and Services Administration, Centers for Medicare & Medicaid Services, National Institutes of Health, and Agency for Healthcare Research and Quality).

`(2) OTHER EX OFFICIO MEMBERS- The Secretary shall invite the following individuals to serve as ex officio members of the task force:

`(A) A representative from the Department of Transportation.

`(B) A representative from the Department of Defense.

`(C) A representative from the Department of Veterans Affairs.

`(D) A representative from the Office of Personnel Management.

`(E) A physician representative from the board of directors of the Organ Procurement and Transplantation Network.

`(F) Representatives of other Federal agencies or departments as determined to be appropriate by the Secretary.

`(c) ANNUAL REPORT- In addition to activities carried out under subsection (a), the task force shall support the development of the annual report under section 378D(c).

`(d) TERMINATION- The task force may be terminated at the discretion of the Secretary following the completion of at least 2 annual reports under section 378D(c). Upon such termination, the Secretary shall provide for the on-going coordination of federally supported or conducted organ donation and research activities.'.

SEC. 102. DEMONSTRATION PROJECTS, EDUCATION, AND PUBLIC AWARENESS.

Part H of title III of the Public Health Service Act (42 U.S.C 273 et seq.) is amended by inserting after section 378, as added by section 101, the following:

`SEC. 378A. DEMONSTRATION PROJECTS, EDUCATION, AND PUBLIC AWARENESS.

`(a) GRANTS TO INCREASE DONATION RATES- The Secretary shall award peer-reviewed grants to public and non-profit private entities, including States, to carry out studies and demonstration projects to increase organ donation and recovery rates, including living donation.

`(b) ORGAN DONATION PUBLIC AWARENESS PROGRAM- The Secretary shall establish a public education program in cooperation with existing national public awareness campaigns to increase awareness about organ donation and the need to provide for an adequate rate of such donations.

`(c) DEVELOPMENT OF CURRICULA AND OTHER EDUCATION ACTIVITIES-

`(1) IN GENERAL- The Secretary, in coordination with the Organ Procurement and Transplantation Network and other appropriate organizations, shall support the development and dissemination of model curricula to train health care professionals and other appropriate professionals (including religious leaders in the community, funeral directors, and law enforcement officials) in issues surrounding organ donation, including methods to approach patients and their families, cultural sensitivities, and other relevant issues.

`(2) HEALTH CARE PROFESSIONALS- For purposes of subparagraph (A), the term `health care professionals' includes--

`(A) medical students, residents and fellows, attending physicians (through continuing medical education courses and other methods), nurses, social workers, and other allied health professionals;

`(B) hospital- or other health care-facility based chaplains; and

`(C) emergency medical personnel.

`(d) LIMITED DEMONSTRATION PROJECTS-

`(1) REPORTS- Not later than 1 year after the date of enactment of this section, the Secretary shall prepare and submit to the appropriate committees of Congress a report evaluating the ethical implications of proposals for demonstration projects to increase cadaveric donation.

`(2) AUTHORITY- Notwithstanding section 301 of the National Organ Transplant Act (42 U.S.C. 274e), upon the submission of and consistent with the report by the Secretary under paragraph (1), the Secretary may conduct up to 3 demonstration projects to increase cadaveric donation.

`(3) DURATION- Each project shall last no more than 3 years, and shall be conducted in a limited number of sites or areas.

`(4) REVIEW- The Secretary shall provide for the ongoing ethical review and evaluation of such projects to ensure that such projects are administered effectively as possible and in accordance with the stated purpose of this subsection under paragraph (2).

`(e) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to carry out this section, $5,000,000 for fiscal year 2004, and such sums as may be necessary for each of the fiscal years 2005 through 2008.

`SEC. 378B. GRANTS REGARDING HOSPITAL ORGAN DONATION COORDINATORS.

`(a) AUTHORITY-

`(1) IN GENERAL- The Secretary may award grants to qualified organ procurement organizations under section 371 to establish programs coordinating organ donation activities of eligible hospitals and qualified organ procurement organizations under section 371. Such activities shall be coordinated to increase the rate of organ donations for such hospitals.

`(2) ELIGIBLE HOSPITAL- For purposes of this section, an eligible hospital is a hospital that performs significant trauma care, or a hospital or consortium of hospitals that serves a population base of not fewer than 200,000 individuals.

`(b) ADMINISTRATION OF COORDINATION PROGRAM- A condition for the receipt of a grant under subsection (a) is that the applicant involved agree that the program under such subsection will be carried out jointly--

`(1) by representatives from the eligible hospital and the qualified organ procurement organization with respect to which the grant is made; and

`(2) by such other entities as the representatives referred to in paragraph (1) may designate.

`(c) EVALUATIONS- Within 3 years after the award of grants under this section, the Secretary shall ensure an evaluation of programs carried out pursuant to subsection (a) in order to determine the extent to which the programs have increased the rate of organ donation for the eligible hospitals involved. Such evaluation shall include recommendations on whether the program should be expanded to include other grantees, such as hospitals.

`(d) MATCHING REQUIREMENT- The Secretary may not award a grant to a qualifying organ donation entity under this section unless such entity agrees that, with respect to costs to be incurred by the entity in carrying out activities for which the grant was awarded, the entity shall contribute (directly or through donations from public or private entities) non-Federal contributions in cash or in kind, in an amount equal to not less than 30 percent of the amount of the grant awarded to such entity.

`(e) FUNDING- For the purpose of carrying out this section, there are authorized to be appropriated $3,000,000 for fiscal year 2004, and such sums as may be necessary for each of fiscal years 2005 through 2008.'.

SEC. 103. STUDIES RELATING TO ORGAN DONATION AND THE RECOVERY, PRESERVATION, AND TRANSPORTATION OF ORGANS.

Part H of title III of the Public Health Service Act (42 U.S.C. 273 et seq.) is amended by inserting after section 378B, as added by section 102, the following:

`SEC. 378C. STUDIES RELATING TO ORGAN DONATION AND THE RECOVERY, PRESERVATION, AND TRANSPORTATION OF ORGANS.

`(a) DEVELOPMENT OF SUPPORTIVE INFORMATION- The Secretary, acting through the Administrator of the Health Resources and Services Administration and the Director of the Agency for Healthcare Research and Quality shall develop scientific evidence in support of efforts to increase organ donation and improve the recovery, preservation, and transportation of organs.

`(b) ACTIVITIES- In carrying out subsection (a), the Secretary shall--

`(1) conduct or support evaluation research to determine whether interventions, technologies, or other activities improve the effectiveness, efficiency, or quality of existing organ donation practice;

`(2) undertake or support periodic reviews of the scientific literature to assist efforts of professional societies to ensure that the clinical practice guidelines that they develop reflect the latest scientific findings;

`(3) ensure that scientific evidence of the research and other activities undertaken under this section is readily accessible by the organ procurement workforce; and

`(4) work in coordination with the appropriate professional societies as well as the Organ Procurement and Transplantation Network and other organ procurement and transplantation organizations to develop evidence and promote the adoption of such proven practices.

`(c) RESEARCH, DEMONSTRATIONS, AND TRAINING- The Secretary, acting through the Administrator of the Health Resources and Services Administration and the Director of the Agency for Healthcare Research and Quality, as appropriate, shall provide support for research, demonstrations, and training as appropriate, to--

`(1) develop a uniform clinical vocabulary for organ recovery;

`(2) apply information technology and telecommunications to support the clinical operations of organ procurement organizations;

`(3) enhance the skill levels of the organ procurement workforce in undertaking quality improvement activities; and

`(4) assess specific organ recovery, preservation, and transportation technologies.

`(d) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2004, and such sums as may be necessary for each of fiscal years 2005 through 2008.'.

SEC. 104. REPORTS.

Part H of title III of the Public Health Service Act (42 U.S.C. 273 et seq.) is amended by inserting after section 378C, as added by section 103, the following:

`SEC. 378D. REPORTS.

`(a) IOM REPORT ON BEST PRACTICES-

`(1) IN GENERAL- The Secretary shall enter into a contract with the Institute of Medicine to conduct an evaluation of the organ donation practices of organ procurement organizations, States, other countries, and other appropriate organizations.

`(2) CONSIDERATIONS- In conducting the evaluation under paragraph (1), the Institute of Medicine shall examine--

`(A) existing barriers to organ donation, including among minority populations; and

`(B) best donation and recovery practices, including--

`(i) mandated choice and presumed consent;

`(ii) organ procurement organization and provider consent practices (including consent best practices);

`(iii) the efficacy and reach of existing State routine notification laws with respect to organ procurement organizations;

`(iv) the impact of requests for consent in States where registry registration constitutes express consent under State law; and

`(v) recommendations with respect to achieving higher donation rates, including among minority populations.

`(3) REPORT- Not later than 18 months after the date of enactment of this section, the Institute of Medicine shall submit to the Secretary a report concerning the evaluation conducted under this subsection. Such report shall include recommendations for administrative actions and, if necessary, legislation in order to replicate the best practices identified in the evaluation and to otherwise increase organ donation and recovery rates.

`(b) IOM REPORT ON LIVING DONATIONS-

`(1) IN GENERAL- The Secretary shall enter into a contract with the Institute of Medicine to conduct an evaluation of living donation practices and procedures. Such evaluation shall include, but is not limited to an assessment of issues relating to informed consent and the health risks associated with living donation (including possible reduction of long-term effects).

`(2) REPORT- Not later than 18 months after the date of enactment of this section, the Institute of Medicine shall submit to the Secretary a report concerning the evaluation conducted under this subsection.

`(c) REPORT ON DONATION AND RECOVERY ACTIVITIES-

`(1) IN GENERAL- The Secretary as part of the report specified in 274d shall submit an evaluation concerning federally supported or conducted organ donation and recovery activities, including donation and recovery activities evaluated or conducted under the amendments made by the Organ Donation and Recovery Improvement Act to increase organ donation and recovery rates.

`(2) REQUIREMENTS- To the extent practicable, each evaluation submitted under paragraph (1) shall--

`(A) evaluate the effectiveness of activities, identify best practices, and make recommendations regarding the adoption of best practices with respect to organ donation and recovery; and

`(B) assess organ donation and recovery activities that are recently completed, ongoing, or planned.'.

SEC. 105. TECHNICAL AMENDMENT CONCERNING ORGAN PURCHASES.

Section 301(c)(2) of the National Organ Transplant Act (42 U.S.C. 274e(c)(2)) is amended by adding at the end the following: `Such term does not include familial, emotional, psychological, or physical benefit to an organ donor, recipient, or any other party to an organ donation event.'.

TITLE II--LIVING DONATION EXPENSES

SEC. 201. 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 the reimbursement of travel and subsistence expenses incurred by individuals toward making living donations of their organs (in this section referred as `donating individuals'); and

`(2) providing for the reimbursement of such incidental nonmedical 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

`(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 such types of expenses as are paid for 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) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there is authorized to be appropriated $5,000,000 for fiscal year 2004, and such sums as may be necessary for each of fiscal years 2005 through 2008.'.

TITLE III--ORGAN REGISTRIES

SEC. 301. ADVISORY COMMITTEE.

Part H of title III of the Public Health Service Act (42 U.S.C. 273 et seq.) is amended by inserting after section 371 the following:

`SEC. 371A. ADVISORY COMMITTEE.

`(a) IN GENERAL- Not later than 6 months after enactment, the Secretary shall establish an advisory committee to study existing organ donor registries and make recommendations to Congress regarding the costs, benefits, and expansion of such registries.

`(b) MEMBERSHIP- The committee shall be composed of 10 members of whom--

`(1) at least 1 member shall be a physician with experience performing transplants;

`(2) at least 1 member shall have experience in organ recovery;

`(3) at least 1 member shall be representative of an organization with experience conducting national awareness campaigns and donor outreach;

`(4) at least 1 member shall be representative of a State with an existing donor registry;

`(5) at least 1 member shall have experience with national information systems where coordination occurs with State-based systems; and

`(6) at least 1 member shall represent donor families, transplant recipients, and those awaiting transplantation.

`(c) INITIAL MEETING- Not later than 30 days after the date on which all members of the committee have been appointed, the committee shall hold its first meeting.

`(d) MEETINGS- The committee shall meet at the call of the Chairman who shall be selected by the Secretary.

`(e) COMPENSATION- Each member of the committee shall not receive compensation for services provided under this section.

`(f) TRAVEL EXPENSES- The members of the committee shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for employees of agencies under subchapter I of chapter 57 of title 5, United States Code, while away from their homes or regular places of business in the performance of services for the committee.

`(g) ADMINISTRATIVE SUPPORT- The Secretary shall ensure that the committee is provided with administrative support or any other technical assistance that such committee needs in carrying out its duties.

`(h) PERMANENT COMMITTEE- Section 14 of the Federal Advisory Committee Act shall not apply to the committee established under this section.

`(i) REPORT- Not later than 1 year after the date on which the committee is established under subsection (a), the committee shall prepare and submit to Congress a report regarding the status of organ donor registries, current best practices, the effect of organ donor registries on organ donation rates, the merits of expanding organ donor registries, issues relating to consent, the efficacy of current privacy protections, potential forms of technical assistance, and recommendations regarding improving the effectiveness and establishing formal linkages between organ donor registries.

`(j) DEFINITION- In this section, the term `organ donor registry' means a listing of individuals who have indicated their desire to donate their organs and tissue upon their death through driver's license preferences or other formal mechanisms.'.

SEC. 302. NATIONAL LIVING DONOR REGISTRY.

Part H of title III of the Public Health Service Act (42 U.S.C. 273 et seq.), as amended by section 301, is further amended by inserting after section 371A the following:

`SEC. 371B. NATIONAL LIVING DONOR REGISTRY.

`The Secretary shall by contract establish and maintain a registry of individuals who have served as living organ donors for the purpose of evaluating the long-term health effects associated with living organ donations.'.

SEC. 303. QUALIFIED ORGAN PROCUREMENT ORGANIZATIONS.

Section 371(a) of the Public Health Service Act (42 U.S.C. 273(a)) is amended by striking paragraph (3).

END