II

107TH CONGRESS

1ST SESSION S. 1062

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

facilitate interstate linkage and 24-hour access to State donor registries,

and for other purposes.

IN THE SENATE OF THE UNITED STATES

JUNE 19, 2001

Mr. DURBIN (for himself, Ms. COLLINS, Mr. BIDEN, Mrs. CLINTON, Mr.

FEINGOLD, Mrs. FEINSTEIN, Mr. JOHNSON, and Mr. INOUYE) introduced

the following bill; which was read twice and referred to the Committee

on Health, Education, Labor, and Pensions

A BILL

To amend the Public Health Service Act to promote organ

donation and facilitate interstate linkage and 24-hour

access to State donor registries, 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 Donor Outreach, Net5 work, and Timely Exchange Act’’ or the ‘‘DONATE Act’’.
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1 SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE

2 ACT.

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

4 (42 U.S.C. 273 et seq.) is amended by inserting after sec5 tion 371 the following:

6 ‘‘SEC. 371A. NATIONAL ORGAN AND TISSUE DONOR REG7 ISTRY RESOURCE CENTER.

8 ‘‘(a) IN GENERAL.—The Secretary, acting through

9 the Administrator of the Health Resources and Services

10 Administration, shall establish a National Organ and Tis11 sue Donor Registry Resource Center (referred to in this

12 section as the ‘Center’).

13 ‘‘(b) DUTIES.—The Center established under sub14 section (a) shall—

15 ‘‘(1) advance the development, expansion, and

16 evaluation of State donor registries;

17 ‘‘(2) facilitate timely access to and exchange of

18 accurate donor information between State registries

19 on a 24-hour a day basis;

20 ‘‘(3) develop consensus guidelines on a standard

21 registry model, including whether or not such reg22 istries should include living donor information, that

23 represents best practices, including—

24 ‘‘(A) the core functions and content of a

25 registry;
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1 ‘‘(B) clear legal and ethical standards for

2 minimum levels of information necessary to es3 tablish informed consent;

4 ‘‘(C) standardized, legally verifiable con5 sent documentation;

6 ‘‘(D) privacy protections, including guide7 lines for accessing the registry database;

8 ‘‘(E) data exchange protocols and stand9 ards; and

10 ‘‘(F) methods to legally enforce the wishes

11 of the donor;

12 ‘‘(4) provide technical assistance to the States

13 for the establishment and operation of State reg14 istries, including assistance in developing model leg15 islation for State registries; and

16 ‘‘(5) maintain a registry information clearing17 house to collect, synthesize, and disseminate best

18 practices information about donor registries, includ19 ing maintaining a web site.

20 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

21 is authorized to be appropriated to carry out this section,

22 $5,000,000 for each of the fiscal years 2002 through

23 2006.
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1 ‘‘SEC. 371B. GRANTS FOR STATE ORGAN AND TISSUE

2 DONOR REGISTRIES.

3 ‘‘(a) PROGRAM AUTHORIZED.—The Secretary shall

4 award grants or cooperative agreements to eligible entities

5 to support the development, enhancement, expansion, and

6 evaluation of State organ and tissue donor registries.

7 ‘‘(b) ELIGIBLE ENTITY.—In this section, the term

8 ‘eligible entity’ means a State.

9 ‘‘(c) USE OF FUNDS.—An eligible entity that receives

10 a grant or cooperative agreement under subsection (a)

11 shall—

12 ‘‘(1) provide for authorization under State law

13 of the registry;

14 ‘‘(2) establish benchmarks for improvement in

15 organ donation in the State;

16 ‘‘(3) at a minimum, make registries available to

17 organ procurement organizations and to other State

18 agencies 24 hours, 7 days a week and without a fee;

19 ‘‘(4) include provisions that protect the privacy

20 of donors; and

21 ‘‘(5) include legal protections for individuals

22 complying with the law, including those who carry

23 out advance directives and organ, tissue, and eye

24 procurement.

25 ‘‘(d) APPLICATION.—An entity that desires a grant

26 or cooperative agreement under subsection (a) shall sub-
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1 mit an application to the Secretary at such time, in such

2 manner, and containing such information as the Secretary

3 may reasonably require.

4 ‘‘(e) REPORT.—An eligible entity that receives a

5 grant or cooperative agreement under subsection (a) shall

6 prepare and submit a report to the Secretary that de7 scribes the manner in which such entity has used amounts

8 received through a grant under this section and assesses

9 initiatives that may be replicated in other States.

10 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There

11 is authorized to be appropriated to carry out this section,

12 $10,000,000 for each of the fiscal years 2002 through

13 2006.

14 ‘‘SEC. 371C. ADVISORY TASK FORCE.

15 ‘‘(a) IN GENERAL.—The Secretary shall establish an

16 advisory task force to study State registries and make rec17 ommendations to Congress regarding such registries.

18 ‘‘(b) MEMBERSHIP.—The task force shall be com19 posed of 10 members of whom—

20 ‘‘(1) at least 1 member shall be a physician

21 with experience performing transplants;

22 ‘‘(2) at least 1 member shall have experience in

23 organ procurement;
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1 ‘‘(3) at least 2 members shall be representatives

2 of organizations with experience conducting national

3 awareness campaigns and donor outreach;

4 ‘‘(4) at least 2 members shall be representatives

5 of States with existing donor registries;

6 ‘‘(5) at least 1 member shall have experience

7 with national information systems where coordina8 tion occurs with State-based systems; and

9 ‘‘(6) at least 1 member shall represent donor

10 families, transplant recipients, and those awaiting

11 transplantation.

12 ‘‘(c) TERM.—Members shall be appointed for 3-year

13 rotating terms. Any vacancy in the task force shall not

14 affect its powers, but shall be filled in the same manner

15 as the original appointment.

16 ‘‘(d) INITIAL MEETING.—Not later than 30 days

17 after the date on which all members of the task force have

18 been appointed, the task force shall hold its first meeting.

19 ‘‘(e) MEETINGS.—The task force shall meet at the

20 call of the Chairman who shall be selected by the Sec21 retary.

22 ‘‘(f) COMPENSATION.—Each member of the task

23 force shall not receive compensation for services provided

24 under this section.
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1 ‘‘(g) TRAVEL EXPENSES.—The members of the task

2 force shall be allowed travel expenses, including per diem

3 in lieu of subsistence, at rates authorized for employees

4 of agencies under subchapter I of chapter 57 of title 5,

5 United States Code, while away from their homes or reg6 ular places of business in the performance of services for

7 the task force.

8 ‘‘(h) ADMINISTRATIVE SUPPORT.—The Secretary

9 shall ensure that the task force is provided with adminis10 trative support or any other technical assistance that such

11 task force needs in carrying out its duties.

12 ‘‘(i) PERMANENT COMMITTEE.—Section 14 of the

13 Federal Advisory Committee Act shall not apply to the

14 task force established under this section.

15 ‘‘(j) REPORT.—Not later than 1 year after the date

16 of enactment of this section, and in the subsequent year

17 as well, the task force established under subsection (a)

18 shall prepare and submit to Congress a report regarding

19 the status of State registries, current best practices, rec20 ommendations to increase the number and quality of State

21 registries, and recommendations regarding the merits of

22 a national database or ways to improve linkages between

23 State registries and consider and make recommendations

24 regarding whether any Federal funds for the establish25 ment of new registries should be limited to State agency
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1 processes that are linked to the ability to make a legally

2 binding gift.

3 ‘‘SEC. 371D. EXPENSES INCURRED TOWARD LIVING ORGAN

4 DONATION.

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

6 to eligible entities to pay for travel, subsistence, and other

7 necessary nonmedical miscellaneous expenses related to

8 living organ donation by any donating individual.

9 ‘‘(b) DEFINITIONS.—In this section:

10 ‘‘(1) DONATING INDIVIDUAL.—The term ‘do11 nating individual’ means any individual who is mak12 ing, or in good faith plans to make, a living donation

13 of his or her organs.

14 ‘‘(2) ELIGIBLE ENTITY.—The term ‘eligible en15 tity’ means a State, transplant center, qualified

16 organ procurement organization under section 371,

17 or other public or private entity.

18 ‘‘(3) NECESSARY NONMEDICAL MISCELLANEOUS

19 EXPENSES.—The term ‘necessary nonmedical mis20 cellaneous expenses’ means such necessary nonmed21 ical miscellaneous expenses as the Secretary deems

22 appropriate.

23 ‘‘(c) PREFERENCE.—Preference shall be given to in24 tended recipients or donors of organs with incomes not

25 exceeding $60,000 (as adjusted for fiscal year 2002 and
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1 subsequent fiscal years to offset the effects of inflation oc2 curring after the beginning of fiscal year 2001).

3 ‘‘(d) USE OF FUNDS.—

4 ‘‘(1) IN GENERAL.—An eligible entity that re5 ceives a grant under subsection (a) shall use funds

6 received through such grant to pay for travel, sub7 sistence, and other necessary nonmedical miscella8 neous expenses of any donating individual.

9 ‘‘(2) FAMILY.—An eligible entity that receives a

10 grant under subsection (a) may use funds received

11 through such grant to pay for travel, subsistence,

12 and other necessary nonmedical miscellaneous ex13 penses of 1 or more family members of any donating

14 individual to accompany the donating individual in

15 making the living donation.

16 ‘‘(3) PROHIBITION.—An eligible entity shall not

17 pay the travel, subsistence, and other necessary non18 medical miscellaneous expenses of a donating indi19 vidual if payment has been made, or can reasonably

20 be expected to be made, with respect to such

21 expenses—

22 ‘‘(A) under any State compensation pro23 gram, under an insurance policy, or under any

24 Federal or State health benefits program;
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1 ‘‘(B) by an entity that provides health

2 services on a prepaid basis; or

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

4 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

5 is authorized to be appropriated to carry out this section,

6 $15,000,000 for fiscal year 2002, and such sums as may

7 be necessary for each of the fiscal years 2003 through

8 2006.

9 ‘‘SEC. 371E. ORGAN DONATION PUBLIC AWARENESS PRO10 GRAM.

11 ‘‘(a) NATIONAL PROGRAM.—The Secretary shall es12 tablish a public education program to increase awareness

13 about organ donation and the need to provide for an ade14 quate rate of such donations.

15 ‘‘(b) GRANTS TO ENTITIES.—The Secretary may

16 award grants to public and nonprofit private entities to

17 carry out studies and demonstration projects with respect

18 to providing for an adequate rate of organ donation.

19 ‘‘(c) GRANTS TO STATES.—

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

21 grants to States to establish programs designed to

22 increase awareness regarding organ donation and

23 the number of organ donors within the State, includ24 ing living donors.
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1 ‘‘(2) USE OF FUNDS.—A State that receives a

2 grant under paragraph (1) may use funds received

3 through such grant to—

4 ‘‘(A) work in a partnership with other pub5 lic agencies or private sector institutions for

6 education and awareness efforts, information

7 dissemination, activities pertaining to the State

8 organ donor registry, and other innovative do9 nation specific initiatives, including living dona10 tion;

11 ‘‘(B) establish yearly benchmarks for im12 provement in organ donation rates in the State;

13 and

14 ‘‘(C) develop, enhance or expand a State

15 donor registry, which shall be available to organ

16 procurement organizations and other State

17 agencies upon a search request 24 hours, 7

18 days a week.

19 ‘‘(3) APPLICATION.—A State shall submit an

20 application at such time, in such manner, and con21 taining such information as the Secretary may rea22 sonably require.

23 ‘‘(4) REPORT.—A State that receives a grant

24 under paragraph (1) shall prepare and submit to the

25 Secretary a report on an annual basis that describes
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1 the State’s use of funds received under this sub2 section, and assesses the use of such funds and any

3 initiatives for potential replication in other States.

4 ‘‘(d) REPORT.—The Secretary shall annually submit

5 to the Congress a report on the activities carried out under

6 this section, including provisions describing the extent to

7 which the activities have affected the rate of organ dona8 tion.

9 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

10 is authorized to be appropriated to carry out this section,

11 $5,000,000 for fiscal year 2002, and such sums as may

12 be necessary for each of the fiscal years 2003 through

13 2006.’’.

14 SEC. 3. CONGRESSIONAL MEDAL.

15 (a) IN GENERAL.—The Secretary of the Treasury

16 shall design and strike a bronze medal with suitable em17 blems, devices, and inscriptions, to be determined by the

18 Secretary of the Treasury, to commemorate organ donors

19 and their families.

20 (b) ELIGIBILITY.—Any organ donor, or the family or

21 family member of any organ donor, shall be eligible for

22 a medal described in subsection (a).

23 (c) DOCUMENTATION.—The Secretary of Health and

24 Human Services shall direct the entity holding the Organ
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1 Procurement and Transplantation Network (hereafter in

2 this Act referred to as ‘‘OPTN’’) to contract to—

3 (1) establish an application procedure requiring

4 the relevant organ procurement organization, as de5 scribed in section 371(b)(1) of the Public Health

6 Service Act (42 U.S.C. 273(b)(1)), through which an

7 individual or their family made an organ donation,

8 to submit to the OPTN contractor documentation

9 supporting the eligibility of that individual or their

10 family to receive a medal described in subsection (a);

11 and

12 (2) determine, through the documentation pro13 vided, and, if necessary, independent investigation,

14 whether the individual or family is eligible to receive

15 a medal described in subsection (a).

16 (d) DELIVERY TO THE SECRETARY OF HEALTH AND

17 HUMAN SERVICES.—The Secretary of the Treasury shall

18 deliver medals struck pursuant to this Act to the Secretary

19 of Health and Human Services.

20 (e) DELIVERY TO ELIGIBLE RECIPIENTS.—The Sec21 retary of Health and Human Services shall direct the

22 OPTN contractor to arrange for the presentation to the

23 relevant organ procurement organization all medals struck

24 pursuant to this Act to individuals or families that the
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1 OPTN contractor has determined to be eligible to receive

2 medals under this Act.

3 (f) LIMITATION.—

4 (1) IN GENERAL.—Except as provided in para5 graph (2), only 1 medal may be presented to a fam6 ily under subsection (b). Such medal shall be pre7 sented to the donating family member, or in the case

8 of a deceased donor, the family member who signed

9 the consent form authorizing, or who otherwise au10 thorized, the donation of the organ involved.

11 (2) EXCEPTION.—In the case of a family in

12 which more than 1 member is an organ donor, the

13 OPTN contractor may present an additional medal

14 to each such organ donor or their family.

15 (g) DUPLICATE MEDALS.—

16 (1) IN GENERAL.—The Secretary of Health and

17 Human Services or the OPTN contractor may pro18 vide duplicates of the medal described in subsection

19 (a) to any recipient of a medal under subsection (e),

20 under such regulations as the Secretary of Health

21 and Human Services may issue.

22 (2) LIMITATION.—The price of a duplicate

23 medal shall be sufficient to cover the cost of such

24 duplicates.
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1 (h) NATIONAL MEDALS.—The medals struck pursu2 ant to this section are national medals for purposes of sec3 tion 5111 of title 31, United States Code.

4 (i) GENERAL WAIVER OF PROCUREMENT REGULA5 TIONS.—No provision of law governing procurement or

6 public contracts shall be applicable to the procurement of

7 goods or services necessary for carrying out the provisions

8 of this Act.

9 (j) SOLICITATION OF DONATIONS.—

10 (1) IN GENERAL.—The Secretary of the Treas11 ury may enter into an agreement with the OPTN

12 contractor to collect funds to offset expenditures re13 lating to the issuance of medals authorized under

14 this section.

15 (2) PAYMENT OF FUNDS.—

16 (A) IN GENERAL.—Except as provided in

17 subparagraph (B), all funds received by the

18 Organ Procurement and Transplantation Net19 work under paragraph (1) shall be promptly

20 paid by the Organ Procurement and Transplan21 tation Network to the Secretary of the Treas22 ury.

23 (B) LIMITATION.—Not more than 5 per24 cent of any funds received under paragraph (1)

25 shall be used to pay administrative costs in-
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1 curred by the OPTN contractor as a result of

2 an agreement established under this section.

3 (3) NUMISMATIC PUBLIC ENTERPRISE FUND.—

4 Notwithstanding any other provision of law—

5 (A) all amounts received by the Secretary

6 of the Treasury under paragraph (2)(A) shall

7 be deposited in the Numismatic Public Enter8 prise Fund, as described in section 5134 of title

9 31, United States Code; and

10 (B) the Secretary of the Treasury shall

11 charge such fund with all expenditures relating

12 to the issuance of medals authorized under this

13 section.

14 (4) START-UP COSTS.—A 1-time amount not to

15 exceed $55,000 shall be provided to the OPTN con16 tractor to cover initial start-up costs. The amount

17 will be paid back in full within 3 years of the date

18 of the enactment of this Act from funds received

19 under paragraph (1).

20 (5) NO NET COST TO THE GOVERNMENT.—The

21 Secretary of the Treasury shall take all actions nec22 essary to ensure that the issuance of medals author23 ized under subsection (a) results in no net cost to

24 the Government.

25 (k) DEFINITIONS.—In this section:
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1 (1) ORGAN.—The term ‘‘organ’’ means the

2 human kidney, liver, heart, lung, pancreas, and any

3 other human organ (other than corneas and eyes)

4 specified by regulation of the Secretary of Health

5 and Human Services or the OPTN contractor.

6 (2) ORGAN PROCUREMENT AND TRANSPLAN7 TATION NETWORK.—The term ‘‘Organ Procurement

8 and Transplantation Network’’ means the Organ

9 Procurement and Transplantation Network estab10 lished under section 372 of the Public Health Serv11 ice Act (42 U.S.C. 274).

12 (l) SUNSET PROVISION.—This section shall be effec13 tive during the 5-year period beginning on the date of the

14 enactment of this Act.

15 SEC. 4. IOM REPORT.

16 (a) IN GENERAL.—The Secretary shall enter into a

17 contract with the Institute of Medicine to conduct an eval18 uation of the organ donation practices of organ procure19 ment organizations, States, other countries, and other ap20 propriate organizations that have achieved a higher than

21 average organ donation rate.

22 (b) BARRIERS.—In conducting the evaluation under

23 subsection (a), the Institute of Medicine shall examine ex24 isting barriers to organ donation.
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1 (c) REPORT.—Not later than 18 months after the

2 date of enactment of this section, the Institute of Medicine

3 shall submit to the Secretary of Health and Human Serv4 ices a report concerning the evaluation conducted under

5 this section. Such report shall include recommendations

6 for administrative actions and, if necessary, legislation in

7 order to replicate the best practices identified in the eval8 uation and to otherwise increase organ donation and pro9 curement rates.

10 SEC. 5. ESTABLISHMENT OF PROGRAM OF GRANTS RE11 GARDING HOSPITAL ORGAN DONATION CO12 ORDINATORS.

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 374 the following:

16 ‘‘SEC. 374A. GRANTS REGARDING HOSPITAL ORGAN DONA17 TION COORDINATORS.

18 ‘‘(a) IN GENERAL.—

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

20 grants to qualifying organ donation entities to estab21 lish programs coordinating organ donation activities

22 of eligible hospitals, including coordinating with

23 qualified organ procurement organizations under

24 section 371. Such activities shall be coordinated to
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1 increase the rate of organ donations for such hos2 pitals.

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

4 this section, an eligible hospital is a public or non5 profit private hospital that performs significant trau6 ma care, or a public or nonprofit private hospital or

7 consortium of such hospitals that serves a popu8 lation base of not fewer than 200,000 individuals.

9 ‘‘(3) QUALIFYING ORGAN DONATION ENTITY.—

10 In this section, the term ‘qualifying organ donation

11 entity’ means—

12 ‘‘(A) an eligible hospital; or

13 ‘‘(B) a qualified organ procurement orga14 nization under section 371.

15 ‘‘(b) PREFERENCE IN MAKING GRANTS.—In making

16 grants under subsection (a), the Secretary shall give pref17 erence to an applicant if the Secretary determines that

18 the probable result of such a grant would be a significant

19 increase in the rate of organ donation for the eligible hos20 pital involved.

21 ‘‘(c) ADMINISTRATION OF COORDINATION PRO22 GRAM.—A condition for the receipt of a grant under sub23 section (a) is that the applicant involved agree that the

24 program under such subsection will be carried out

25 jointly—
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1 ‘‘(1) by representatives from the eligible hos2 pital and the qualified organ procurement organiza3 tion with respect to which the grant is made; and

4 ‘‘(2) by such other entities as the representa5 tives referred to in paragraph (1) may designate.

6 ‘‘(d) EVALUATIONS; REPORT TO CONGRESS.—

7 ‘‘(1) EVALUATIONS.—The Secretary shall, di8 rectly or through contracts with public or private en9 tities, provide for annual evaluations of programs

10 carried out pursuant to subsection (a) in order to

11 determine the extent to which the programs have in12 creased the rate of organ donation for the eligible

13 hospitals involved.

14 ‘‘(2) REPORT.—Not later than 1 year after the

15 date on which amounts are first appropriated pursu16 ant to subsection (f), and annually thereafter, the

17 Secretary shall submit to the appropriate committees

18 of the Congress a report that summarizes evalua19 tions under paragraph (1).

20 ‘‘(e) MATCHING REQUIREMENT.—The Secretary may

21 not award a grant to a qualifying organ donation entity

22 under this section unless such entity agrees that, with re23 spect to costs to be incurred by the entity in carrying out

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

25 make available (directly or through donations from public
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1 or private entities) non-Federal contributions in an

2 amount equal to 30 percent of the grant awarded to such

3 entity.

4 ‘‘(f) FUNDING.—

5 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

6 For the purpose of carrying out this section, there

7 are authorized to be appropriated $3,000,000 for

8 fiscal years 2002 through 2005.

9 ‘‘(2) ALLOCATION.—Of the amounts appro10 priated under paragraph (1) for a fiscal year, the

11 Secretary shall reserve 50 percent for grants under

12 subsection (a) to qualifying organ donation entities

13 described in paragraph (3)(A) of such subsection

14 and 50 percent for grants under subsection (a) to

15 qualifying organ donation entities described in para16 graph (3)(B) of such subsection.’’.

17 SEC. 6. LIMITATION.

18 Nothing in this Act shall affect organ and tissue allo19 cation. Standard State and national practices that deter20 mine the appropriate procurement organization for obtain21 ing consent for an individual organ or tissue donation shall

22 continue to apply to such determinations.

Æ