Union Calendar No. 250
106TH CONGRESS
1ST SESSION
H. R. 2418
[Report No. 106–429]
A BILL
To amend the Public Health Service Act to revise
and extend programs relating to organ procure-
ment and transplantation.
NOVEMBER 1, 1999
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union,
and ordered to be printed
IB
Union Calendar No. 250
106TH CONGRESS
1ST SESSION
H. R. 2418
[Report No. 106–429]
To amend the Public Health Service Act to revise and extend programs
relating to organ procurement and transplantation.
IN THE HOUSE OF REPRESENTATIVES
JULY 1, 1999
Mr. BILIRAKIS (for himself, Mr. GREEN of Texas, and Mr. PALLONE) intro-
duced the following bill; which was referred to the Committee on Com-
merce
NOVEMBER 1, 1999
Additional sponsors: Mr. JEFFERSON, Mr. FROST, Mr. BENTSEN, Ms. JACK-
SON-LEE of Texas, Mr. DEUTSCH, Mr. WALDEN of Oregon, Mr. BACHUS,
Mr. KLECZKA, Mr. WHITFIELD, Mr. GOODE, Mr. TAUZIN, Mr. FOLEY,
Mr. DEAL of Georgia, Mr. DEFAZIO, Mr. BAKER, Mr. CUNNINGHAM, Mr.
COOKSEY, Mr. HINCHEY, Mr. ROMERO-BARCELO´, Mr. COBURN, Mr.
CRAMER, Mr. RILEY, Mr. VITTER, Mr. WATTS of Oklahoma, Mr.
LARGENT, Mr. HILLIARD, Mr. HALL of Texas, Mr. ISTOOK, Mr. JOHN,
Mr. MCCRERY, Mr. CALLAHAN, Mrs. KELLY, Mr. GILMAN, Mr. DEMINT,
Mrs. NORTHUP, Mr. GRAHAM, Mr. CLEMENT, Mr. GORDON, Mrs. ROU-
KEMA, Mr. WU, Mr. LATHAM, Mr. BRYANT, Mr. NORWOOD, Ms. MCKIN-
NEY, Mr. FRANKS of New Jersey, Mr. SPRATT, Mr. GANSKE, Mr.
SPENCE, Mr. CLYBURN, Mr. FLETCHER, Ms. BALDWIN, Mr. WATKINS,
Mr. PICKETT, Mr. WAMP, Mr. BLUNT, Mr. CHAMBLISS, Mr. LEWIS of
Georgia, Mr. DICKS, Mr. ROTHMAN, Mrs. THURMAN, Mr. BOYD, Mr.
MATSUI, Mr. OXLEY, Mr. DUNCAN, Mr. TANNER, Mr. ROGERS, Mr.
FRELINGHUYSEN, Mr. SANFORD, Mrs. MINK of Hawaii, Mr. LOBIONDO,
Mr. MENENDEZ, Mr. SMITH of New Jersey, Mr. ANDREWS, Mr.
PASCRELL, Mr. PAYNE, Mr. SAXTON, Mr. HOLT, Mr. LINDER, Ms. RIV-
ERS, Mr. JENKINS, Mr. HILLEARY, Mr. NETHERCUTT, Mr. WELDON of
Florida, and Mr. CANADY of Florida
NOVEMBER 1, 1999
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on July 1, 1999]
A BILL
To amend the Public Health Service Act to revise and extend
programs relating to organ procurement and transplantation.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Organ Procurement and
Transplantation Network Amendments of 1999’’.
SEC. 2. FINDINGS.
(a) IN GENERAL.—The Congress finds as follows:
(1) It is in the public interest to maintain and
improve a system for promoting and supporting a
central network in the private sector to assist organ
procurement organizations and transplant centers in
the distribution of organs among transplant patients
and the provision of organ transplantation services,
and to assure quality and facilitate collaboration
among network members and individual medical
practitioners participating in network activities.
(2) The Organ Procurement and Transplan-
tation Network (‘‘Network’’), which was established in
the private sector pursuant to a contract awarded by
the Federal Government, should continue to be oper-
ated by a nonprofit private entity pursuant to a con-
tract with the Federal Government.
(3) The Federal Government should continue to
provide Federal oversight of and financial assistance
for the services provided by the Network.
(4) The responsibility for developing, estab-
lishing, and maintaining medical criteria and stand-
ards for organ procurement and transplantation be-
longs in the private sector and is a function of the
Network.
(5) The Federal Government should assist the ef-
forts of the Network to serve patient and donor fami-
lies in procuring and distributing organs.
(6) The Federal Government should carry out
programs to educate the public with respect to organ
donation, including the need to provide for an ade-
quate rate of such donations.
(b) SENSE OF CONGRESS REGARDING FAMILY DISCUS-
SIONS OF ORGAN DONATIONS.—The Congress recognizes the
importance of families pledging to each other to share their
lives as organ and tissue donors and acknowledges the im-
portance of discussing organ and tissue donation as a fam-
ily.
(c) SENSE OF CONGRESS REGARDING LIVING DONA-
TIONS OF ORGANS.—The Congress—
(1) recognizes the generous contribution made by
each living individual who has donated an organ to
save a life; and
(2) acknowledges the advances in medical tech-
nology that have enabled organ transplantation with
organs donated by living individuals to become a via-
ble treatment option for an increasing number of pa-
tients.
SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK.
(a) IN GENERAL.—Section 372 of the Public Health
Service Act (42 U.S.C. 274) is amended to read as follows:
‘‘ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK
‘‘SEC. 372. (a) IN GENERAL.—The Secretary shall by
contract provide for the continuing operation of an Organ
Procurement and Transplantation Network (in this section
referred to as the ‘Network’), which contract shall be award-
ed to a nonprofit private entity that has expertise and expe-
rience in organ procurement and transplantation. The Net-
work shall meet the following requirements:
‘‘(1) The Network shall be an independent, non-
profit private entity that is a separate legal entity
from the entity to which such contract is awarded.
‘‘(2) The Network shall in accordance with cri-
teria under subsection (b)(3) include as members
qualified organ procurement organizations (as de-
scribed in section 371(b)), transplant centers, and
other entities that have a demonstrated interest in the
fields of organ donation or transplantation. (Such
members are in this section referred to as ‘Network
participants’.)
‘‘(3) The Network shall have a board of directors
(in this section referred to as the ‘Board’). The Board
shall, after consultation with Network participants,
establish the policies for carrying out the functions
described in this section for the Network.
‘‘(4) The Board shall be in accordance with the
following:
‘‘(A) The Board shall include representa-
tives of qualified organ procurement organiza-
tions, transplant centers, voluntary health asso-
ciations, and the general public, including a rea-
sonable proportion of the members of the Board
who are patients awaiting a transplant or trans-
plant recipients or individuals who have donated
an organ or family members of patients, recipi-
ents or donors.
‘‘(B) The Board shall establish membership
categories and qualifications with respect to serv-
ing on the Board, and shall have exclusive au-
thority to admit individuals to membership on
the Board. Transplant surgeons and transplant
physicians shall comprise not less than 50 per-
cent of the membership of the Board. The Board
shall be limited to a total of 42 members.
‘‘(C) The Board shall have an executive
committee, and such other committees as the
Board determines to be appropriate.
‘‘(D) The chair of each such committee shall
be selected so as to ensure the continuity of lead-
ership for the Board.
‘‘(b) GENERAL FUNCTIONS.—The following applies to
the Network:
‘‘(1) The Network shall establish and operate a
national system to match organs and individuals who
need organ transplants, especially individuals whose
immune system makes it difficult for them to receive
organs.
‘‘(2) The national system shall maintain one or
more lists of individuals who need organ transplants,
shall be operated in accordance with established med-
ical criteria, shall be operated through the use of com-
puters, and may function on a regionalized basis.
‘‘(3) The Network shall establish criteria for
being a Network participant, shall establish medical
criteria for listing patients and for allocating organs,
and shall provide to members of the public an oppor-
tunity to comment with respect to such criteria.
‘‘(4) The Network shall maintain a twenty-four-
hour telephone and computer service to facilitate
matching organs with individuals included in the list.
‘‘(5) The Network shall assist organ procurement
organizations in the distribution of organs. The dis-
tribution of organs shall be based on medical criteria
established by the Network, and also shall be based on
equity and ethics without regard to economic status
of those awaiting organ transplants and without po-
litical control or influence.
‘‘(6) The Network shall adopt and use standards
of quality for the acquisition and transportation of
donated organs, including standards regarding the
transmission of infectious diseases.
‘‘(7) The Network shall prepare and distribute,
on a regionalized basis (and, to the extent practicable,
among regions or on a national basis), samples of
blood sera from individuals who are included on the
list and whose immune system makes it difficult for
them to receive organs, in order to facilitate matching
the compatibility of such individuals with organ do-
nors.
‘‘(8) The Network shall coordinate, as appro-
priate, the transportation of organs from organ pro-
curement organizations to transplant centers.
‘‘(9) The Network shall work actively to increase
the supply of donated organs.
‘‘(10) The Network shall establish criteria, poli-
cies, and procedures to address the disparity in mor-
tality rates between children and adults while waiting
for organ transplants.
‘‘(c) SCIENTIFIC REGISTRY.—
‘‘(1) IN GENERAL.—The Network shall maintain
a scientific registry of patients awaiting organ trans-
plantation, persons from whom organs are removed
for transplantation, and organ transplant recipients
for the ongoing evaluation of the scientific and clin-
ical status of organ transplantation.
‘‘(2) REPORTS.—The Network shall prepare for
inclusion in the report under section 375 an analysis
of scientifically and clinically valid information de-
rived from the scientific registry under paragraph
(1).
‘‘(d) INFORMATION AND DATA.—
‘‘(1) IN GENERAL.—The Network shall—
‘‘(A) provide information to physicians and
other health professionals regarding organ dona-
tion and transplantation; and
‘‘(B) collect, analyze, and annually publish
data concerning organ donation and transplan-
tation.
‘‘(2) INFORMATION FOR PATIENTS AND GENERAL
PUBLIC.—The Network shall make available to pa-
tients in need of organ transplants information in ac-
cordance with the following:
‘‘(A) The information shall be transplant-
related information specific to transplant centers
that are Network participants, which informa-
tion has been determined by the Network to be
scientifically and clinically valid.
‘‘(B) The information shall be designed to
assist patients and referring physicians in choos-
ing a transplant center, including information
on the supply of and demand for organs.
‘‘(C) With respect to the patient involved,
the information shall (taking into account pa-
tients in similar medical circumstances) include
the following as applied to specific transplant
centers:
‘‘(i) The probability of receiving an
organ transplant.
‘‘(ii) The length of time that similarly
situated patients have waited historically to
receive a transplant.
‘‘(iii) Medical outcomes for similarly
situated patients, which information shall
be adjusted to reflect the medical risk factors
for such patients.
‘‘(D) With respect to the patient involved,
the information shall include the information de-
scribed in subparagraph (C) as applied to the
service areas of specific qualified organ procure-
ment organizations (other than such areas in
which there is only one transplant center).
‘‘(E) Information under this paragraph
shall be updated not less frequently than once a
year.
‘‘(3) ANNUAL
PUBLIC
REPORT.—The Network
shall annually make available to the public a report
on the overall status of organ procurement and trans-
plantation.
‘‘(4) CONFIDENTIALITY.—Except for the release
of information that is authorized under paragraph
(2) or (3) by the Network, neither the Network nor the
Secretary has authority to release the following infor-
mation (unless authorized in writing by the patient
or other entity with which the data is concerned):
‘‘(A) Information that permits direct or in-
direct identification of any patient who is wait-
ing for a transplant, or who is an organ trans-
plant patient or recipient of an organ.
‘‘(B) Information that permits direct or in-
direct identification of any potential or actual
organ donors.
‘‘(C) Information that permits direct or in-
direct identification of participants in Network
deliberations or determinations related to practi-
tioner or institutional qualifications, due process
proceedings or peer review activities, except for
information announcing final decisions of the
Network.
This paragraph may not be construed as prohibiting
the disclosure of information within the Network, in-
cluding information disclosed in the course of inter-
active organ sharing operations within the Network.
‘‘(e) STUDIES.—
‘‘(1) IN GENERAL.—The Network shall carry out
studies and demonstration projects for the purpose of
improving procedures for organ procurement and al-
location, including but not limited to projects to ex-
amine and attempt to increase transplantation
among populations with special needs or limited ac-
cess to transplantation, and among children.
‘‘(2) CERTAIN
TECHNOLOGIES.—The Network
may study the impact of possible transplantation of
animal organs (xenotransplantation) and other tech-
nologies to determine the impact upon, and prevent
negative effects on, the fair and effective use of human
allograft organs.
‘‘(f) QUALITY ASSURANCE; MONITORING OF NETWORK
PARTICIPANTS.—The Network shall monitor the operations
of Network participants to the extent appropriate for deter-
mining whether the participants are maintaining compli-
ance with criteria under subsection (b)(3). In monitoring
a Network participant under the preceding sentence, the
Network shall inform the participant of any findings indi-
cating noncompliance by the participant.
‘‘(g) QUALITY
ASSURANCE; PEER
REVIEW
PRO-
CEEDINGS.—
‘‘(1) IN GENERAL.—The Network shall develop a
peer review system for assuring that members of the
Network comply with criteria under subsection (b)(3).
‘‘(2) NONCOMPLIANCE.—
‘‘(A) PAYMENT OF DAMAGES.—The Network
shall require that, as a condition of being a Net-
work participant, each such participant agree
that the Network may, through a peer review
proceeding under paragraph (1), require the par-
ticipant to pay damages for the failure of the
participant to comply with criteria under sub-
section (b)(3). The Network shall establish proce-
dures to ensure that such proceedings are con-
ducted in an impartial manner, with adequate
opportunity for the Network participant involved
to receive a hearing. The Network shall identify
various types of violations of such criteria and
specify the maximum amount of damages that
the Network may under this subparagraph re-
quire a Network participant to pay for the type
of violation involved.
‘‘(B) RESTRICTING ACCESS TO ALLOCATION
SYSTEM.—If under subparagraph (A) it has been
determined that a Network participant has en-
gaged in substantial violations of criteria under
subsection (b)(3), the Network may restrict the
extent to which such participant is permitted to
receive allocations of organs through the Net-
work.
‘‘(C) STATUS
OF
NETWORK
PARTICIPANTS
WITH
RESPECT
TO
VIOLATIONS.—Subject to
paragraph (3), the Network may take actions to
make the public aware of the extent to which a
Network participant has been required to pay
damages under subparagraph (A) or has been the
subject of restrictions under subparagraph (B).
‘‘(3) CONFIDENTIALITY.—With respect to a peer
review proceeding under paragraph (1), neither the
Network nor the Secretary has authority to release
data or information to the public relating to the pro-
ceedings without the written permission of all the
parties involved, except that if damages under para-
graph (2) are required to be paid, the requirement
may be publicly announced after the conclusion of the
proceeding.
‘‘(h) ADMINISTRATIVE PROVISIONS.—
‘‘(1) LIMITATION ON AMOUNT OF CONTRACT.—
The amount provided under a contract under sub-
section (a) in any fiscal year may not exceed
$6,000,000 for the operation of the Network, including
the scientific registry under subsection (c). Such limi-
tation does not apply to amounts provided under the
contract for increasing organ donation and procure-
ment.
‘‘(2) RELATIONSHIP BETWEEN SECRETARY AND
NETWORK.—The administrative and procedural func-
tions described in this section for the Network shall be
carried out in accordance with the mutual agreement
of the Secretary and the Network. For purposes of the
preceding sentence, functions that are scientific, clin-
ical, or medical in nature are not administrative or
procedural functions and are within the sole discre-
tion of the Network. With respect to the programs
under titles XVIII and XIX of the Social Security
Act, this section may not be construed as having any
legal effect on such programs, except to the extent that
section 1138 of such Act, or any other provision of
such Act, provides otherwise.
‘‘(3) NONFEDERAL ASSETS OF NETWORK.—
‘‘(A) IN GENERAL.—No assets in the posses-
sion of the Network or revenues collected by the
Network, other than amounts appropriated
under section 378, shall be considered or be treat-
ed as Federal property, Federal revenues, or pro-
gram funds pursuant to a Federal contract, nor
shall such assets, revenues, or nonappropriated
funds be subject to restriction or control by the
Secretary, nor shall any member of the Network
be required by the Secretary to pay any fees to
the Network, nor shall the Secretary be author-
ized to collect or authorize collection of service
fees with respect to the Network or the scientific
registry under subsection (c).
‘‘(B) GIFTS.—This section does not prohibit
the Network from accepting gifts of money or
services, including gifts to carry out activities to
provide for an increase in the rate of organ do-
nation.
‘‘(4) COMMUNITY ENDORSEMENT OF CONTRACT
RECIPIENT.—In the case of any contract under sub-
section (a) that is awarded after the date of the enact-
ment of the Organ Procurement and Transplantation
Network Amendments of 1999, the Secretary shall se-
lect an applicant to receive the contract from among
applicants that have the written endorsement of a
majority of the combined total number of transplant
centers and qualified organ procurement organiza-
tions that are Network participants (without regard
to whether such centers or organizations endorse more
than one applicant for the contract).
‘‘(5) CHANGE
IN
CONTRACT
RECIPIENT.—With
respect to the expiration of the period during which
a contract under subsection (a) is in effect, if the Sec-
retary makes a determination to award the contract
to a different entity than the entity to which the pre-
vious contract under such subsection was awarded,
the Secretary shall publish in the Federal Register a
notice that such change in the administration of the
Network will take place, and the change may not take
effect any sooner than the expiration of the six-month
period beginning on the date on which the notice is
so published. Such a change does not affect the mem-
bership status of any Network participant, or the
membership status of any individual who serves on
the Board (other than any membership position that
is predicated solely on being a representative of the
current contractor under subsection (a)).
‘‘(i) ADDITIONAL PROCEDURES REGARDING OVER-
SIGHT
AND PUBLIC ACCOUNTABILITY.—For purposes of
providing oversight of and public accountability for the op-
eration of the Network, the Secretary shall establish proce-
dures for—
‘‘(1) conducting public hearings and receiving
from interested persons comments regarding criteria
of the Network and critical comments relating to the
manner in which the Network is carrying out its du-
ties under this section;
‘‘(2) providing such comments to the Network
and receiving responses from the Network; and
‘‘(3) the consideration by the Secretary of such
comments.
‘‘(j) EVALUATIONS
BY GENERAL ACCOUNTING OF-
FICE.—
‘‘(1) IN GENERAL.—The Comptroller General of
the United States shall periodically conduct evalua-
tions of the Network, including the structure and
function of the Network and the relationship between
the Secretary and the nonprofit private entity that
under subsection (a) operates the Network. The first
such evaluation shall be completed not later than one
year after the date of the enactment of the Organ Pro-
curement and Transplantation Network Amendments
of 1999, and such an evaluation shall be completed
not later than every second year thereafter.
‘‘(2) INPUT FROM FIELD.—In conducting evalua-
tions under paragraph (1), the Comptroller General
shall consult with organizations that represent trans-
plant surgeons, transplant physicians, transplant
centers, and qualified organ procurement organiza-
tions, and with other experts in the field of organ
transplantation, including experts who are not mem-
bers of the Board of the Network or of the executive
structure of the contractor under subsection (a) .
‘‘(3) PROCEDURES OF NETWORK.—The Network
shall establish procedures for coordinating with the
Comptroller General for purposes of evaluations under
paragraph (1).
‘‘(4) REPORTS TO CONGRESS.—
‘‘(A) COMPTROLLER GENERAL.—The Comp-
troller General shall prepare reports describing
the findings of evaluations under paragraph (1)
and shall submit such reports to the Committee
on Commerce of the House of Representatives
and the Committee on Health, Education, Labor,
and Pensions of the Senate. The Comptroller
General shall provide a copy of each such report
to the Network.
‘‘(B) NETWORK.—Not later than 180 days
after the date on which a report is submitted
under subparagraph (A), the Network shall sub-
mit to each of the committees specified in such
subparagraph a report describing any actions
the Network has taken in response to the report
under subparagraph (A).’’.
(b) RULE OF CONSTRUCTION.—The amendments made
by this Act may not be construed as affecting the duration
of the contract under section 372 of the Public Health Serv-
ice Act that was in effect on the day before the date of the
enactment of this Act.
SEC. 4. ADDITIONAL AMENDMENTS.
(a) IN GENERAL.—Part H of title III of the Public
Health Service Act (42 U.S.C. 273 et seq.) is amended—
(1) by striking section 373;
(2) in section 374—
(A) in subsection (b)(1), by inserting after
‘‘organization’’ the following: ‘‘and other organi-
zations for the purpose of increasing the supply
of transplantable organs’’;
(B) in subsection (c), by striking ‘‘or 373’’
each place such term appears; and
(C) in subsection (d), by amending para-
graph (2) to read as follows:
‘‘(2) The term ‘organ’, with respect to transplan-
tation into humans, means the human or other ani-
mal kidney, liver, heart, lung, pancreas, and any
other organ (other than human corneas and eyes)
specified by the Secretary by regulation. For purposes
of section 372(c), such term includes bone marrow.’’;
(3) in section 375—
‘‘(e) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘covered vicinity’ has the meaning
given such term in subsection (c)(2).
‘‘(2) The term ‘donating individuals’ has the
meaning indicated for such term in subsection (a)(1),
subject to subsection (b)(2)(A).
‘‘(3) The term ‘qualifying expenses’ means the
expenses authorized for purposes of subsection (a),
subject to subsection (b)(2)(B).
‘‘(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 2000
through 2005.’’.
SEC. 6. PUBLIC AWARENESS; STUDIES AND DEMONSTRA-
TIONS.
Part H of title III of the Public Health Service Act,
as amended by section 5 of this Act, is amended by inserting
after section 376 the following section:
‘‘PUBLIC AWARENESS; STUDIES AND DEMONSTRATIONS
‘‘SEC. 377. (a) PUBLIC AWARENESS.—The Secretary
shall (directly or through grants or contracts) carry out a
program to educate the public with respect to organ dona-
tion, including the need to provide for an adequate rate of
such donations.
‘‘(b) STUDIES AND DEMONSTRATIONS.—The Secretary
may make grants to public and nonprofit private entities