HR 2544 — Securing the U.S. Organ Procurement and Transplantation Network Act

changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, and existing law in which no 
change is proposed is shown in roman):

 PUBLIC HEALTH SERVICE ACT

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TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

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 Part H--Organ Transplants

 organ procurement organizations

 Sec. 371. (a)(1) The Secretary may make grants for the 
planning of qualified organ procurement organizations described 
in subsection (b).
 (2) The Secretary may make grants for the establishment, 
initial operation, consolidation, and expansion of qualified 
organ procurement organizations described in subsection (b).
 (b)(1) A qualified organ procurement organization for which 
grants may be made under subsection (a) is an organization 
which, as determined by the Secretary, will carry out the 
functions described in paragraph (2) and--
 (A) is a nonprofit entity,
 (B) has accounting and other fiscal procedures (as 
 specified by the Secretary) necessary to assure the 
 fiscal stability of the organization,
 (C) has an agreement with the Secretary to be 
 reimbursed under title XVIII of the Social Security Act 
 for the procurement of kidneys,
 (D) notwithstanding any other provision of law, has 
 met the other requirements of this section and has been 
 certified or recertified by the Secretary within the 
 previous 4-year period as meeting the performance 
 standards to be a qualified organ procurement 
 organization through a process that either--
 (i) granted certification or recertification 
 within such 4-year period with such 
 certification or recertification in effect as 
 of January 1, 2000, and remaining in effect 
 through the earlier of--
 (I) January 1, 2002; or
 (II) the completion of 
 recertification under the requirements 
 of clause (ii); or
 (ii) is defined through regulations that are 
 promulgated by the Secretary by not later than 
 January 1, 2002, that--
 (I) require recertifications of 
 qualified organ procurement 
 organizations not more frequently than 
 once every 4 years;
 (II) rely on outcome and process 
 performance measures that are based on 
 empirical evidence, obtained through 
 reasonable efforts, of organ donor 
 potential and other related factors in 
 each service area of qualified organ 
 procurement organizations;
 (III) use multiple outcome measures 
 as part of the certification process; 
 and
 (IV) provide for a qualified organ 
 procurement organization to appeal a 
 decertification to the Secretary on 
 substantive and procedural grounds;
 (E) has procedures to obtain payment for non-renal 
 organs provided to transplant centers,
 (F) has a defined service area that is of sufficient 
 size to assure maximum effectiveness in the procurement 
 and equitable distribution of organs, and that either 
 includes an entire metropolitan statistical area (as 
 specified by the Director of the Office of Management 
 and Budget) or does not include any part of the area,
 (G) has a director and such other staff, including 
 the organ donation coordinators and organ procurement 
 specialists necessary to effectively obtain organs from 
 donors in its service area, and
 (H) has a board of directors or an advisory board 
 which--
 (i) is composed of--
 (I) members who represent hospital 
 administrators, intensive care or 
 emergency room personnel, tissue banks, 
 and voluntary health associations in 
 its service area,
 (II) members who represent the public 
 residing in such area,
 (III) a physician with knowledge, 
 experience, or skill in the field of 
 [histocompatability] histocompatibility 
 or an individual with a doctorate 
 degree in a biological science with 
 knowledge, experience, or skill in the 
 field of histocompatibility,
 (IV) a physician with knowledge or 
 skill in the field of neurology, and
 (V) from each transplant center in 
 its service area which has arrangements 
 described in paragraph (3)(G) with the 
 organization, a member who is a surgeon 
 who has practicing privileges in such 
 center and who performs organ 
 transplant surgery,
 (ii) has the authority to recommend policies 
 for the procurement of organs and the other 
 functions described in paragraph (3), and
 (iii) has no authority over any other 
 activity of the organization.
 (2)(A) Not later than 90 days after the date of the enactment 
of this paragraph, the Secretary shall publish in the Federal 
Register a notice of proposed rulemaking to establish criteria 
for determining whether an entity meets the requirement 
established in paragraph (1)(E).
 (B) Not later than 1 year after the date of enactment of this 
paragraph, the Secretary shall publish in the Federal Register 
a final rule to establish the criteria described in 
subparagraph (A).
 (3) An organ procurement organization shall--
 (A) have effective agreements, to identify potential 
 organ donors, with a substantial majority of the 
 hospitals and other health care entities in its service 
 area which have facilities for organ donations,
 (B) conduct and participate in systematic efforts, 
 including professional education, to acquire all usable 
 organs from potential donors,
 (C) arrange for the acquisition and preservation of 
 donated organs and provide quality standards for the 
 acquisition of organs which are consistent with the 
 standards adopted by the Organ Procurement and 
 Transplantation Network under section 372(b)(2)(E), 
 including arranging for testing with respect to 
 identifying organs that are infected with human 
 immunodeficiency virus (HIV),
 (D) arrange for the appropriate tissue typing of 
 donated organs,
 (E) have a system to allocate donated organs 
 equitably among transplant patients according to 
 established medical criteria,
 (F) provide or arrange for the transportation of 
 donated organs to transplant centers,
 (G) have arrangements to coordinate its activities 
 with transplant centers in its service area,
 (H) participate in the Organ Procurement 
 Transplantation Network established under section 372,
 (I) have arrangements to cooperate with tissue banks 
 for the retrieval, processing, preservation, storage, 
 and distribution of tissues as may be appropriate to 
 assure that all usable tissues are obtained from 
 potential donors,
 (J) evaluate annually the effectiveness of the 
 organization in acquiring potentially available organs, 
 and
 (K) assist hospitals in establishing and implementing 
 protocols for making routine inquiries about organ 
 donations by potential donors.
 (c) Pancreata procured by an organ procurement organization 
and used for islet cell transplantation or research shall be 
counted for purposes of certification or recertification under 
subsection (b).

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 organ procurement and transplantation network

 Sec. 372. (a) [The Secretary shall by contract] In General_
The Secretary shall provide for the [establishment and] 
continued operation of an Organ Procurement and Transplantation 
Network which meets the requirements of subsection (b). [The 
amount provided under such contract in any fiscal year may not 
exceed $7,000,000. Funds for such contracts shall be made 
available from funds available to the Public Health Service 
from appropriations for fiscal years beginning after fiscal 
year 1984.] The Secretary may award grants, contracts, or 
cooperative agreements, as the Secretary determines 
appropriate, for purposes of carrying out this section.
 (b) Composition._[(1) The Organ Procurement and 
Transplantation Network shall carry out the functions described 
in paragraph (2) and shall--]
 [(A) be a private nonprofit entity that has an 
 expertise in organ procurement and transplantation, 
 and]
 (1) In general.--The Organ Procurement and 
 Transplantation Network shall--
 (A) be operated through awards to public or 
 private entities made by the Secretary that are 
 distinct from the awards made to support the 
 organization tasked with supporting the board 
 of directors described in subparagraph (B); and
 (B) have a board of directors--
 (i) that includes representatives of organ 
 procurement organizations (including 
 organizations that have received grants under 
 section 371), transplant centers, voluntary 
 health associations, and the general public; 
 and
 (ii) that shall establish an executive 
 committee and other committees, whose 
 chairpersons shall be selected to ensure 
 continuity of leadership for the board.
 (2) The Organ Procurement and Transplantation Network shall--
 (A) establish in one location or through regional 
 centers--
 (i) a national list of individuals who need 
 organs, and
 (ii) a national system, through the use of 
 computers and in accordance with established 
 medical criteria, to match organs and 
 individuals included in the list, especially 
 individuals whose immune system makes it 
 difficult for them to receive organs,
 (B) establish membership criteria and medical 
 criteria for allocating organs and provide to members 
 of the public an opportunity to comment with respect to 
 such criteria,
 (C) maintain a twenty-four-hour telephone service to 
 facilitate matching organs with individuals included in 
 the list,
 (D) assist organ procurement organizations in the 
 nationwide distribution of organs equitably among 
 transplant patients,
 (E) adopt and use standards of quality for the 
 acquisition and transportation of donated organs,
 (F) 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 donors,
 (G) coordinate, as appropriate, the transportation of 
 organs from organ procurement organizations to 
 transplant centers,
 (H) provide information to physicians and other 
 health professionals regarding organ donation,
 (I) collect, analyze, and publish data concerning 
 organ donation and transplants,
 (J) carry out studies and demonstration projects for 
 the purpose of improving procedures for organ 
 procurement and allocation,
 (K) work actively to increase the supply of donated 
 organs,
 (L) submit to the Secretary an annual report 
 containing information on the comparative costs and 
 patient outcomes at each transplant center affiliated 
 with the organ procurement and transplantation network,
 (M) recognize the differences in health and in organ 
 transplantation issues between children and adults 
 throughout the system and adopt criteria, polices, and 
 procedures that address the unique health care needs of 
 children,
 (N) carry out studies and demonstration projects for 
 the purpose of improving procedures for organ donation 
 procurement and allocation, including but not limited 
 to projects to examine and attempt to increase 
 transplantation among populations with special needs, 
 including children and individuals who are members of 
 racial or ethnic minority groups, and among populations 
 with limited access to transportation, and
 (O) provide that for purposes of this paragraph, the 
 term ``children'' refers to individuals who are under 
 the age of 18.
 (3) Clarification.--In adopting and using standards 
 of quality under paragraph (2)(E), the Organ 
 Procurement and Transplantation Network may adopt and 
 use such standards with respect to organs infected with 
 human immunodeficiency virus (in this paragraph 
 referred to as ``HIV''), provided that any such 
 standards ensure that organs infected with HIV may be 
 transplanted only into individuals who--
 (A) are infected with HIV before receiving 
 such organ; and
 (B)(i) are participating in clinical research 
 approved by an institutional review board under 
 the criteria, standards, and regulations 
 described in subsections (a) and (b) of section 
 377E; or
 (ii) if the Secretary has determined under 
 section 377E(c) that participation in such 
 clinical research, as a requirement for such 
 transplants, is no longer warranted, are 
 receiving a transplant under the standards and 
 regulations under section 377E(c).
 (c) The Secretary shall establish procedures for--
 (1) receiving from interested persons critical 
 comments relating to the manner in which the Organ 
 Procurement and Transplantation Network is carrying out 
 the duties of the Network under subsection (b); and
 (2) the consideration by the Secretary of such 
 critical comments.

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 general provisions respecting grants and contracts

 Sec. 374. (a) No grant may be made under this part or 
contract entered into under section 372 or 373 unless an 
application therefor has been submitted to, and approved by, 
the Secretary. Such an application shall be in such form and 
shall be submitted in such manner as the Secretary shall by 
regulation prescribe.
 (b)(1) A grant for planning under section 371(a)(1) may be 
made for one year with respect to any organ procurement 
organization and may not exceed $100,000.
 (2) Grants under section 371(a)(2) may be made for two years. 
No such grant may exceed $500,000 for any year and no organ 
procurement organization may receive more than $800,000 for 
initial operation or expansion.
 (3) Grants or contracts under section 371(a)(3) may be made 
for not more than 3 years.
 (c)(1) The Secretary shall determine the amount of a grant or 
contract made under section 371 or 373. Payments under such 
grants and contracts may be made in advance on the basis of 
estimates or by the way of reimbursement, with necessary 
adjustments on account of underpayments or overpayments, and in 
such installments and on such terms and conditions as the 
Secretary finds necessary to carry out the purposes of such 
grants and contracts.
 (2)(A) Each recipient of a grant or contract under [section 
371 or 373] section 371, 372, or 373 shall keep such records as 
the Secretary shall prescribe, including records which fully 
disclose the amount and disposition by such recipient of the 
proceeds of such grant or contract, the total cost of the 
undertaking in connection with which such grant or contract was 
made, and the amount of that portion of the cost of the 
undertaking supplied by other sources, and such other records 
as will facilitate an effective audit.
 (B) The Secretary and the Comptroller General of the United 
States, or any of their duly authorized representatives, shall 
have access for the purpose of audit and examination to any 
books, documents, papers, and records of the recipient of a 
grant or contract under [section 371 or 373] section 371, 372, 
or 373 that are pertinent to such grant or contract.
 (d) For purposes of this part:
 (1) The term ``transplant center'' means a health 
 care facility in which transplants of organs are 
 performed.
 (2) The term ``organ'' means the human kidney, liver, 
 heart, lung, pancreas, and any other human organ (other 
 than corneas and eyes) specified by the Secretary by 
 regulation and for purposes of section 373, such term 
 includes bone marrow.

 administration

 Sec. 375. The Secretary shall designate and maintain an 
identifiable administrative unit in the Public Health Service 
to--
 (1) administer this part and coordinate with the 
 organ procurement activities under title XVIII of the 
 Social Security Act[,];
 (2) conduct a program of public information to inform 
 the public of the need for organ donations[,];
 (3) provide technical assistance to organ procurement 
 organizations, the Organ Procurement and 
 Transplantation Network established under section 372, 
 and other entities in the health care system involved 
 in organ donations, procurement, and [transplants, and] 
 transplants; and
 (4) provide information--
 
 [(i)] (A) to patients, their families, and 
 their physicians about transplantation; and
 [(ii)] (B) to patients and their families 
 about the resources available nationally and in 
 each State, and the comparative costs and 
 patient outcomes at each transplant center 
 affiliated with the organ procurement and 
 transplantation network, in order to assist the 
 patients and families with the costs associated 
 with transplantation.

 report

 Sec. 376. Not later than [February 10 of 1991 and of each 
second year thereafter] 2 years after the date of enactment of 
the Securing the U.S. Organ Procurement and Transplantation 
Network Act and every second year thereafter, the Secretary 
shall publish, and submit to the Committee on Energy and 
Commerce of the House of Representatives and the [Committee on 
Labor and Human Resources of the Senate.] Committee on Health, 
Education, Labor, and Pensions of the Senate, a report on the 
scientific and clinical status of organ transplantation. The 
Secretary shall consult with the Director of the National 
Institutes of Health and the Commissioner of the Food and Drug 
Administration in the preparation of the report.

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