Title 42 — The Public Health and Welfare
Part H · Chapter 6A — Public Health Service
§ 273. Organ procurement organizations
Statutory text
Grant authority of Secretary
The Secretary may make grants for the planning of qualified organ procurement organizations described in subsection (b).
The Secretary may make grants for the establishment, initial operation, consolidation, and expansion of qualified organ procurement organizations described in subsection (b).
Qualified organizations
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) 1 and—
is a nonprofit entity,
has accounting and other fiscal procedures (as specified by the Secretary) necessary to assure the fiscal stability of the organization,
has an agreement with the Secretary to be reimbursed under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] for the procurement of kidneys,
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—
granted certification or recertification within such 4-year period with such certification or recertification in effect as of , and remaining in effect through the earlier of—
; or
the completion of recertification under the requirements of clause (ii); or
is defined through regulations that are promulgated by the Secretary by not later than , that—
require recertifications of qualified organ procurement organizations not more frequently than once every 4 years;
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;
use multiple outcome measures as part of the certification process; and
provide for a qualified organ procurement organization to appeal a decertification to the Secretary on substantive and procedural grounds; 2
has procedures to obtain payment for non-renal organs provided to transplant centers,
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,
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
has a board of directors or an advisory board which—
is composed of—
members who represent hospital administrators, intensive care or emergency room personnel, tissue banks, and voluntary health associations in its service area,
members who represent the public residing in such area,
a physician with knowledge, experience, or skill in the field of histocompatibility or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility,
a physician with knowledge or skill in the field of neurology, and
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,
has the authority to recommend policies for the procurement of organs and the other functions described in paragraph (3), and
has no authority over any other activity of the organization.
Not later than 90 days after , 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).1
Not later than 1 year after , the Secretary shall publish in the Federal Register a final rule to establish the criteria described in subparagraph (A).
An organ procurement organization shall—
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,
conduct and participate in systematic efforts, including professional education, to acquire all useable organs from potential donors,
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 274(b)(2)(E) of this title, including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV),
arrange for the appropriate tissue typing of donated organs,
have a system to allocate donated organs equitably among transplant patients according to established medical criteria,
provide or arrange for the transportation of donated organs to transplant centers,
have arrangements to coordinate its activities with transplant centers in its service area,
participate in the Organ Procurement Transplantation Network established under section 274 of this title,
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 useable tissues are obtained from potential donors,
evaluate annually the effectiveness of the organization in acquiring potentially available organs, and
assist hospitals in establishing and implementing protocols for making routine inquiries about organ donations by potential donors.
Pancreata islet cell transplantation or research
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).
Footnotes
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Pub. L. 98–507 title II § 201 · 98 Stat. 2339
Enacted · 42 U.S.C. § 273
July 1, 1944, ch. 373, title III, § 371, as added Pub. L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2342
Source evidence
Code source credit
July 1, 1944, ch. 373, title III, § 371, as added Pub. L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2342Enacted provision · exact public law section
Sec. 201. Part H of title III of the Public Health Service Act is amended to read as follows: “Part H— Organ Transplants “Sec. 371. “assistance for organ procurement organizations (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, and expansion of qualified organ procurement organizations described in subsection (b). “(3) Ln making grants under paragraphs (1) and (2), the Secretary shall— “(A) take into consideration any recommendations made by the Task Force on Organ Transplantation established under Ante, p. 2339. section 101 of the National Organ Transplant Act, and “(B) give special consideration to applications which cover geographical areas which are not adequately served by organ procurement organizations. “(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 42 USC 1395. of kidneys, “(D) has procedures to obtain payment for non-renal organs provided to transplant centers, “(E) has a defined service area which is a geographical area of sufficient size which (unless the service area comprises an entire State) will include at least fifty potential organ donors each year and which either includes an entire standard metropolitan statistical area (as specified by the Office of Management and Budget) or does not include any part of such an area, “(F) 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 “(G) 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, “(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 (2)(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 (2), and “(iii) has no authority over any other activity of the organization. “(2) 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 useable 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)(D), “(D) arrange for the appropriate tissue typing of donated organs, “(E) have a system to allocate donated organs among transplant centers and 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 useable tissues are obtained from potential donors, and “(J) evaluate annually the effectiveness of the organization in acquiring potentially available organs. “(c) For grants under subsection (a) there are authorized to be appropriated $5,000,000 for fiscal year 1985, $8,000,000 for fiscal year 1986, and $12,000,000 for fiscal year 1987. “Sec. 372. “organ procurement and transplantation network (a) The Secretary shall by contract provide for the establishment and 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 $2,000,000. Funds for such contracts shall be made available from funds available to the Public Health Service from appropriations for fiscal years banning after fiscal year 1984. “(b) (1) The Organ Procurement and Transplantation Network shall carry out the functions described in paragraph (2) and shall— “(A) be a private nonprofit entity which is not engaged in any activity unrelated to organ procurement, and “(B) nave a board of directors which includes representatives of organ procurement organizations (including organizations which have received grants under section 371), transplant centers, voluntary health associations, and the general public. “(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) maintain a twenty-four-hour telephone service to facilitate matching organs with individuals included in the list, “(C) assist organ procurement organizations in the distribution of organs which cannot be placed within the service areas of the organizations, “(D) adopt and use standards of quality for the acquisition and transportation of donated organs, “(E) prepare and distribute, on a regionalized 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 compatability of such individuals with organ donors. “(F) coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant centers, “(G) provide information to physicians and other health professionals regarding organ donation, and “(H) collect, analyze, and publish data concerning organ donation and transplante. “Sec. 373. “scientific registry The Secretary shall, by grant or contract, develop and 42 USC 274a. maintain a scientific registry of the recipients of organ transplants. The registry shall include such information respecting patiente and transplant procedures as the Secretary deems necessary to an ongoing evaluation of the scientific and clinical status of organ transplantation. The Secretary shall prepare for inclusion in the report under section 376 an analysis of information derived from the registry. “Sec. 374. “general provisions respecting grants and contracts (a) No grant may be made under section 371 or 373 or Grants. 42 USC 274b. 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) In considering applications for grants under section 371— “(A) the Secretary shall give priority to any applicant which has a formal agreement of cooperation with all transplant centers in its proposed service area, “(B) the Secretary shall give special consideration to organizations which met the requirements of section 371(b) before the date of the enactment of this section, and “(C) the Secretary shall not discriminate against an applicant solely because it provides health care services other than those related to organ procurement. The Secretary may not make a grant for more than one organ Prohibition. procurement organization which serve the same service area. “(2) A grant for planning under section 371 may be made for one year with respect to any organ procurement organization and may not exceed $100,000. “(3) Grants under section 371 for the establishment, initial operation, or expansion of organ procurement organizations 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. “(c) (1) The Secretary shall determine the amount of a grant made under section 371 or 373. Payments under such grants 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. “(2) (A) Each recipient of a grant under section 371 or 373 shall Records. 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, the total cost of the undertaking in connection with which such grant 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 under section 371 or 373 that are pertinent to such grant. “(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. “Sec. 375. “administration The Secretary shall, during fiscal years 1985, 1986, 1987, and 1988, designate and maintain an identifiable administrative unit in the Public Health Service to— “(1) administer this part and coordinate with the organ procurement 42 USC 1395. Public information. 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 receiving funds under section 371, 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 “(4) one year after the date on which the Task Force on Organ Transplantation transmits its final report under section 104(c) of the National Organ Transplant Act, and annually thereafter through fiscal year 1988, submit to Congress an annual report on the status of organ donation and coordination services and include in the report an analysis of the efficiency and effectiveness of the procurement and allocation of organs and a description of problems encountered in the procurement and allocation of organs. “Sec. 376. “report The Secretary shall annually publish 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.”.Organ Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(a)(1) · 102 Stat. 3048
Inserted · 42 U.S.C. § 273(a)(2)
Pub. L. 100–607, § 402(a)(1), inserted “consolidation,” after “initial operation,”
Source evidence
Code amendment note
Subsec. (a)(2). Pub. L. 100–607, § 402(a)(1), inserted “consolidation,” after “initial operation,”.Enacted provision · exact public law section
(1) in paragraph (2), by inserting “consolidation,” after “operation,”;Organ Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(a)(2) · 102 Stat. 3048
Redesignated · 42 U.S.C. § 273(a)(3)
Pub. L. 100–607, § 402(a)(2), added par. (3). Former par. (3) redesignated (4)
Source evidence
Code amendment note
Subsec. (a)(3). Pub. L. 100–607, § 402(a)(2), added par. (3). Former par. (3) redesignated (4).Enacted provision · exact public law section
(2) by redesignating paragraph (3) as paragraph (4) and inserting after paragraph (2) the following new paragraph: “(3) The Secretary may make grants for special projects designed to increase the number of organ donors.”; andOrgan Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(a)(2) · 102 Stat. 3048
Redesignated · 42 U.S.C. § 273(a)(4)
Pub. L. 100–607, § 402(a)(2), redesignated former par. (3) as (4)
Source evidence
Code amendment note
Subsec. (a)(4). Pub. L. 100–607, § 402(a)(2), redesignated former par. (3) as (4).Enacted provision · exact public law section
(2) by redesignating paragraph (3) as paragraph (4) and inserting after paragraph (2) the following new paragraph: “(3) The Secretary may make grants for special projects designed to increase the number of organ donors.”; andOrgan Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(a)(3) · 102 Stat. 3048
Added · 42 U.S.C. § 273(a)(4)(C)
Pub. L. 100–607, § 402(a)(3), added subpar. (C)
Source evidence
Code amendment note
Subsec. (a)(4)(C). Pub. L. 100–607, § 402(a)(3), added subpar. (C).Enacted provision · exact public law section
(3) in paragraph (4) (as redesignated in paragraph (2) of this subsection)— (A) by striking “and” at the end of subparagraph (A); (B) by striking the period at the end and inserting “, and”; and (C) by adding at the end the following new subparagraph: “(C) with respect to carrying out paragraph (3), give special consideration to proposals from existing organ procurement organizations.”.Organ Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(c)(1)(A) · 102 Stat. 3048
Substituted · 42 U.S.C. § 273(b)(1)(E)
Pub. L. 100–607, § 402(c)(1)(A), substituted “size such that” for “size which”
Substituted · 42 U.S.C. § 273(b)(1)(E)
Pub. L. 100–607, § 402(c)(1)(A), substituted “the organization can reasonably expect to procure organs from not less than 50 donors each year” for “will include at least fifty potential organ donors each year”
Source evidence
Code amendment note
Subsec. (b)(1)(E). Pub. L. 100–607, § 402(c)(1)(A), substituted “size such that” for “size which”, and “the organization can reasonably expect to procure organs from not less than 50 donors each year” for “will include at least fifty potential organ donors each year”.Enacted provision · exact public law section
(A) in paragraph (1)(E)— (i) by striking “size which” and inserting “size such that”; and (ii) by striking “will include” and all that follows through “year” and inserting the following: “the organization can reasonably expect to procure organs from not less than 50 donors each year”;Organ Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(c)(2) · 102 Stat. 3048
Amended · 42 U.S.C. § 273(b)(1)(G)(i)(III)
Pub. L. 100–607, § 402(c)(2), as amended by Pub. L. 101–616, § 201(e)
Inserted · 42 U.S.C. § 273(b)(1)(G)(i)(III)
Pub. L. 100–607, § 402(c)(2), as inserted “or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility” before comma at end
Source evidence
Code amendment note
Subsec. (b)(1)(G)(i)(III). Pub. L. 100–607, § 402(c)(2), as amended by Pub. L. 101–616, § 201(e), inserted “or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility” before comma at end.Enacted provision · exact public law section
(2) Section 371(b)(1)(G)(i)(III) is amended by inserting before the comma the following: “or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility”.Organ Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(c)(1)(B) · 102 Stat. 3048
Substituted · 42 U.S.C. § 273(b)(2)(C)
Pub. L. 100–607, § 402(c)(1)(B), substituted “274(b)(2)(E) of this title, including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,” for “274(b)(2)(D) of this title,”
Source evidence
Code amendment note
Subsec. (b)(2)(C). Pub. L. 100–607, § 402(c)(1)(B), substituted “274(b)(2)(E) of this title, including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,” for “274(b)(2)(D) of this title,”.Enacted provision · exact public law section
(B) in paragraph (2)(C), by striking “372(b)(2)(D),” and inserting the following: “372(b)(2)(E), including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,”:Organ Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(c)(1)(C) · 102 Stat. 3048
Substituted · 42 U.S.C. § 273(b)(2)(E)
Pub. L. 100–607, § 402(c)(1)(C), substituted “organs equitably among transplant patients” for “organs among transplant centers and patients”
Source evidence
Code amendment note
Subsec. (b)(2)(E). Pub. L. 100–607, § 402(c)(1)(C), substituted “organs equitably among transplant patients” for “organs among transplant centers and patients”.Enacted provision · exact public law section
(C) in paragraph (2)(E)— (i) by inserting “equitably” after “organs”; and (ii) by striking “centers and”; andOrgan Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(c)(1)(D) · 102 Stat. 3048
Added · 42 U.S.C. § 273(b)(2)(K)
Pub. L. 100–607, § 402(c)(1)(D), added subpar. (K)
Source evidence
Code amendment note
Subsec. (b)(2)(K). Pub. L. 100–607, § 402(c)(1)(D), added subpar. (K).Enacted provision · exact public law section
(D) in paragraph (2)— (i) by striking “and” at the end of subparagraph (I); (ii) by striking the period at the end and inserting “, and”; and (iii) by adding at the end the following new subparagraph: “(K) assist hospitals in establishing and implementing protocols for making routine inquiries about organ donations by potential donors.”.Organ Trans-plant Amendments Act of 1988
Pub. L. 100–607 § 402(d) · 102 Stat. 3048
Amended · 42 U.S.C. § 273(c)
Pub. L. 100–607, § 402(d), amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: “For grants under subsection (a) of this section there are authorized to be appropriated $5,000,000 for fiscal year 1985, $8,000,000 for fiscal year 1986, and $12,000,000 for fiscal year 1987.”
Source evidence
Code amendment note
Subsec. (c). Pub. L. 100–607, § 402(d), amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: “For grants under subsection (a) of this section there are authorized to be appropriated $5,000,000 for fiscal year 1985, $8,000,000 for fiscal year 1986, and $12,000,000 for fiscal year 1987.”Enacted provision · exact public law section
(d) Authorizations of Appropriations.— Section 371(c) (42 U.S.C. 273(c)) is amended to read as follows: “(c) For grants under subsection (a), there is authorized to be appropriated $5,000,000 for each of the fiscal years 1988 through 1990.”Transplant Amendments Act of 1990
Pub. L. 101–616 § 201(a) · 104 Stat. 3279
Substituted · 42 U.S.C. § 273
Pub. L. 101–616, § 201(a), substituted “Organ procurement organizations” for “Assistance for organ procurement organizations” in section catchline
Source evidence
Code amendment note
Pub. L. 101–616, § 201(a), substituted “Organ procurement organizations” for “Assistance for organ procurement organizations” in section catchline.Enacted provision · exact public law section
(a) Section Heading.— Section 371 of the Public Health Service Act (42 U.S.C. 273) is amended in the section heading by striking “assistance for”.Effective date note
Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”Transplant Amendments Act of 1990
Pub. L. 101–616 § 201(b)(1) · 104 Stat. 3279
Substituted · 42 U.S.C. § 273(a)(3)
Pub. L. 101–616, § 201(b)(1), substituted “may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects” for “may make grants for special projects”
Source evidence
Code amendment note
Subsec. (a)(3). Pub. L. 101–616, § 201(b)(1), substituted “may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects” for “may make grants for special projects”.Enacted provision · exact public law section
(1) Special projects— Section 371(a)(3) of the Act (42 U.S.C. 273(a)(3)) is amended by striking “may make grants for special projects” and inserting the following: “may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) and other nonprofit private entities for the purpose of carrying out special projects”.Effective date note
Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”Transplant Amendments Act of 1990
Pub. L. 101–616 § 201(b)(2) · 104 Stat. 3279
Struck · 42 U.S.C. § 273(a)(4)
Pub. L. 101–616, § 201(b)(2), struck out par. (4) which set forth factors to consider in making grants
Source evidence
Code amendment note
Subsec. (a)(4). Pub. L. 101–616, § 201(b)(2), struck out par. (4) which set forth factors to consider in making grants.Enacted provision · exact public law section
(2) Considerations in making certain grants.— Section 371(a) of the Act (42 U.S.C. 273(a)) is amended by striking paragraph (4).Effective date note
Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”Transplant Amendments Act of 1990
Pub. L. 101–616 § 201(c)(1) · 104 Stat. 3279
Amended · 42 U.S.C. § 273(b)(1)(E)
Pub. L. 101–616, § 201(c)(1), amended subpar. (E) generally. Prior to amendment, subpar. (E) read as follows: “has a defined service area which is a geographical area of sufficient size such that (unless the service area comprises an entire State) the organization can reasonably expect to procure organs from not less than 50 donors each year and which either includes an entire standard metropolitan statistical area (as specified by the Office of Management and Budget) or does not include any part of such an area,”
Source evidence
Code amendment note
Subsec. (b)(1)(E). Pub. L. 101–616, § 201(c)(1), amended subpar. (E) generally. Prior to amendment, subpar. (E) read as follows: “has a defined service area which is a geographical area of sufficient size such that (unless the service area comprises an entire State) the organization can reasonably expect to procure organs from not less than 50 donors each year and which either includes an entire standard metropolitan statistical area (as specified by the Office of Management and Budget) or does not include any part of such an area,”.Enacted provision · exact public law section
(1) In general.— Subparagraph (E) of section 371(b)(l) of the Act (42 U.S.C. 273(b)(1)(E)) is amended to read as follows: “(E) 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,”.Effective date note
Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”Transplant Amendments Act of 1990
Pub. L. 101–616 § 201(e) · 104 Stat. 3279
Changed · 42 U.S.C. § 273(b)(1)(G)(i)(III)
Pub. L. 101–616, § 201(e), made technical correction to Pub. L. 100–607, § 402(c)(2). See 1988 Amendment note below
Source evidence
Code amendment note
Subsec. (b)(1)(G)(i)(III). Pub. L. 101–616, § 201(e), made technical correction to Pub. L. 100–607, § 402(c)(2). See 1988 Amendment note below.Enacted provision · exact public law section
(e) Technical Correction Regarding Public Law 100–607.— Section 402(c)(2) of the Health Omnibus Programs Extension of 1988 (Public Law 100–607; 102 Stat. 3115) is amended by inserting “at the 42 USC 273. end” after “the comma”.Effective date note
Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”Transplant Amendments Act of 1990
Pub. L. 101–616 § 201(d) · 104 Stat. 3279
Added · 42 U.S.C. § 273(b)(2); 42 U.S.C. § 273(b)(3)
Pub. L. 101–616, § 201(d), added par. (2)
Redesignated · 42 U.S.C. § 273(b)(2); 42 U.S.C. § 273(b)(3)
Pub. L. 101–616, § 201(d), redesignated former par. (2) as (3)
Source evidence
Code amendment note
Subsec. (b)(2), (3). Pub. L. 101–616, § 201(d), added par. (2) and redesignated former par. (2) as (3).Enacted provision · exact public law section
(d) Effectiveness Regarding Number of Organs Procured.— Section 371(b) of the Public Health Service Act (42 U.S.C. 273(b)) is amended— (1) by redesignating paragraph (2) as paragraph (3); and (2) by inserting after paragraph (1) the following new paragraph: “(2) (A) Not later than 90 days after the date of the enactment of Federal Register, publication. 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).”.Effective date note
Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”Transplant Amendments Act of 1990
Pub. L. 101–616 § 206(b) · 104 Stat. 3279
Struck · 42 U.S.C. § 273(c)
Pub. L. 101–616, § 206(b), struck out subsec. (c) which authorized appropriations for subsec. (a) grants for fiscal years 1988 through 1990
Source evidence
Code amendment note
Subsec. (c). Pub. L. 101–616, § 206(b), struck out subsec. (c) which authorized appropriations for subsec. (a) grants for fiscal years 1988 through 1990.Enacted provision · exact public law section
(b) Conforming Amendment.— Section 371 of the Public Health Service Act (42 U.S.C. 273) is amended by striking subsection (c).Effective date note
Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”Pub. L. 106–505 title VII § 701(c) · 114 Stat. 2314
Added · 42 U.S.C. § 273(b)(1)(D)(H)
Pub. L. 106–505 added subpar. (D)
Redesignated · 42 U.S.C. § 273(b)(1)(D)(H)
Pub. L. 106–505 redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to board of directors or advisory board, and realigned margin of subpar. (F)
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 106–505 added subpar. (D), redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to board of directors or advisory board, and realigned margin of subpar. (F).Enacted provision · exact public law section
(c) Certification and Recertification of Organ Procurement Organizations.— Section 371(b)(1) of the Public Health Service Act (42 U.S.C. 273(b)(1)) is amended— (1) by redesignating subparagraphs (D) through (G) as subparagraphs (E) through (H), respectively; (2) by realigning the margin of subparagraph (F) (as so redesignated) so as to align with subparagraph (E) (as so redesignated); and (3) by inserting after subparagraph (C) the following: “(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 Deadline. 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;”.Consolidated Appropriations Act, 2001
Pub. L. 106–554 § 1(a)(1)(tII)(s219)(b) · 114 Stat. 2763
Added · 42 U.S.C. § 273(b)(1)(D)(H)
Pub. L. 106–554 added subpar. (D) identical to that added by Pub. L. 106–505
Redesignated · 42 U.S.C. § 273(b)(1)(D)(H)
Pub. L. 106–554 redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to director and such other staff obtaining organs from donors in its service area. Additional amendment directing realignment of margin of subpar. (F) could not be executed after amendment by Pub. L. 106–505
Source evidence
Code amendment note
Subsec. (b)(1)(D) to (H). Pub. L. 106–554 added subpar. (D) identical to that added by Pub. L. 106–505 and redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to director and such other staff obtaining organs from donors in its service area. Additional amendment directing realignment of margin of subpar. (F) could not be executed after amendment by Pub. L. 106–505.Enacted provision · exact public law section
(1) H.R. 5656, as introduced on December 14, 2000.Organ Donation and Recovery Improvement Act
Pub. L. 108–216 § 9 · 118 Stat. 584
Struck · 42 U.S.C. § 273(a)(3)
Pub. L. 108–216 struck out par. (3) which read as follows: “The Secretary may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors.”
Source evidence
Code amendment note
Subsec. (a)(3). Pub. L. 108–216 struck out par. (3) which read as follows: “The Secretary may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors.”Enacted provision · exact public law section
SEC. 9. 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).Pancreatic Islet Cell Transplantation Act of 2004
Pub. L. 108–362 § 2 · 118 Stat. 1703
Added · 42 U.S.C. § 273(c)
Pub. L. 108–362 added subsec. (c)
Source evidence
Code amendment note
Subsec. (c). Pub. L. 108–362 added subsec. (c).Enacted provision · exact public law section
SEC. 2. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION. Section 371 of the Public Health Service Act (42 U.S.C. 273) is amended by adding at the end the following: “(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).” .HIV Organ Policy Equity Act
Pub. L. 113–51 § 2(a)(3)(A) · 127 Stat. 579
Redesignated · 42 U.S.C. § 273(b)(1)(E); 42 U.S.C. § 273(b)(1)(F)
Pub. L. 113–51, § 2(a)(3)(A), (B), redesignated subpars. (F) and (G) as (E) and (F), respectively
Struck · 42 U.S.C. § 273(b)(1)(E); 42 U.S.C. § 273(b)(1)(F)
Pub. L. 113–51, § 2(a)(3)(A), (B), struck out former subpar. (E) which was identical to subpar. (D)
Source evidence
Code amendment note
Subsec. (b)(1)(E), (F). Pub. L. 113–51, § 2(a)(3)(A), (B), redesignated subpars. (F) and (G) as (E) and (F), respectively, and struck out former subpar. (E) which was identical to subpar. (D).Enacted provision · exact public law section
(A) striking subparagraph (E);HIV Organ Policy Equity Act
Pub. L. 113–51 § 2(a)(3)(C) · 127 Stat. 579
Redesignated · 42 U.S.C. § 273(b)(1)(G)
Pub. L. 113–51, § 2(a)(3)(C), substituted “(G) has a director” for “(H) has a director”. Former subpar. (G) redesignated (F)
Source evidence
Code amendment note
Subsec. (b)(1)(G). Pub. L. 113–51, § 2(a)(3)(C), substituted “(G) has a director” for “(H) has a director”. Former subpar. (G) redesignated (F).Enacted provision · exact public law section
(C) striking “(H) has a director” and inserting “(G) has a director”; andHIV Organ Policy Equity Act
Pub. L. 113–51 § 2(a)(3)(D)(i) · 127 Stat. 579
Substituted · 42 U.S.C. § 273(b)(1)(H)(i)(V)
Pub. L. 113–51, § 2(a)(3)(D)(i), substituted “paragraph (3)(G)” for “paragraph (2)(G)”
Source evidence
Code amendment note
Subsec. (b)(1)(H)(i)(V). Pub. L. 113–51, § 2(a)(3)(D)(i), substituted “paragraph (3)(G)” for “paragraph (2)(G)”.Enacted provision · exact public law section
(i) in clause (i) (V), by striking “paragraph (2)(G)” and inserting “paragraph (3)(G)”; andHIV Organ Policy Equity Act
Pub. L. 113–51 § 2(a)(3)(D)(ii) · 127 Stat. 579
Substituted · 42 U.S.C. § 273(b)(1)(H)(ii)
Pub. L. 113–51, § 2(a)(3)(D)(ii), substituted “paragraph (3)” for “paragraph (2)”
Source evidence
Code amendment note
Subsec. (b)(1)(H)(ii). Pub. L. 113–51, § 2(a)(3)(D)(ii), substituted “paragraph (3)” for “paragraph (2)”.Enacted provision · exact public law section
(ii) in clause (ii), by striking “paragraph (2)” and inserting “paragraph (3)”.HIV Organ Policy Equity Act
Pub. L. 113–51 § 2(a)(2) · 127 Stat. 579
Substituted · 42 U.S.C. § 273(b)(3)(C)
Pub. L. 113–51, § 2(a)(2), substituted “including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV)” for “including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome”
Source evidence
Code amendment note
Subsec. (b)(3)(C). Pub. L. 113–51, § 2(a)(2), substituted “including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV)” for “including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome”.Enacted provision · exact public law section
(2) Conforming amendment.— Section 371(b)(3)(C) of the Public Health Service Act (42 U.S.C. 273(b)(3)(C); relating to organ procurement organizations) is amended by striking “including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome” and inserting “including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV)”.Securing the U.S. Organ Procurement and Transplantation Network Act
Pub. L. 118–14 § 3(1) · 137 Stat. 69
Substituted · 42 U.S.C. § 273(b)(1)(H)(i)(III)
Pub. L. 118–14 substituted “histocompatibility or an individual” for “histocompatability or an individual”
Source evidence
Code amendment note
Subsec. (b)(1)(H)(i)(III). Pub. L. 118–14 substituted “histocompatibility or an individual” for “histocompatability or an individual”.Enacted provision · exact public law section
(1) in section 371(b)(1)(H)(i)(III) (42 U.S.C. 273(b)(1)(H)(i)(III)), by striking “histocompatability” and inserting “histocompatibility”;
34 of 34 references resolved to an enrolled provision
Editorial Notes
References in Text
Paragraph (2), referred to in subsec. (b)(1), meaning paragraph (2) of subsec. (b) of this section, was redesignated paragraph (3) by section 201(d)(1) of Pub. L. 101–616. See 1990 Amendment note below.
The Social Security Act, referred to in subsec. (b)(1)(C), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XVIII of the Social Security Act is classified generally to subchapter XVIII (§ 1395 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.
Paragraph (1)(E), referred to in subsec. (b)(2)(A), meaning par. (1)(E) of subsec. (b) of this section, probably should refer to par. (1)(F) of subsec. (b) after the redesignations by section 701(c)(1) of Pub. L. 106–505, section 1(a)(1) [title II, § 219(b)(1)] of Pub. L. 106–554, and section 2(a)(3)(B) of Pub. L. 113–51, which successively redesignated such subpar. (E) as (F), (G), and (F). See 2000 and 2013 Amendment notes below.
Prior Provisions
A prior section 273, act July 1, 1944, ch. 373, title III, § 371, as added July 28, 1956, ch. 772, title II, § 201, 70 Stat. 709, authorized grants to the Territory of Alaska for an integrated mental health program, prior to repeal by Pub. L. 86–70, § 31(b)(1), , 73 Stat. 148, effective .
A prior section 371 of act , added by act Aug. 3, 1956, ch. 907, § 1, 70 Stat. 960, was renumbered section 381 and classified to section 275 of this title, prior to repeal by Pub. L. 99–158, § 3(b), , 99 Stat. 879.
Amendments1988–2023 · 6 rounds
2023
Subsec. (b)(1)(H)(i)(III). Pub. L. 118–14 substituted “histocompatibility or an individual” for “histocompatability or an individual”.
2013
Subsec. (b)(1)(E), (F). Pub. L. 113–51, § 2(a)(3)(A), (B), redesignated subpars. (F) and (G) as (E) and (F), respectively, and struck out former subpar. (E) which was identical to subpar. (D).
Subsec. (b)(1)(G). Pub. L. 113–51, § 2(a)(3)(C), substituted “(G) has a director” for “(H) has a director”. Former subpar. (G) redesignated (F).
Subsec. (b)(1)(H)(i)(V). Pub. L. 113–51, § 2(a)(3)(D)(i), substituted “paragraph (3)(G)” for “paragraph (2)(G)”.
Subsec. (b)(1)(H)(ii). Pub. L. 113–51, § 2(a)(3)(D)(ii), substituted “paragraph (3)” for “paragraph (2)”.
Subsec. (b)(3)(C). Pub. L. 113–51, § 2(a)(2), substituted “including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV)” for “including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome”.
2004
Subsec. (a)(3). Pub. L. 108–216 struck out par. (3) which read as follows: “The Secretary may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors.”
Subsec. (c). Pub. L. 108–362 added subsec. (c).
2000
Subsec. (b)(1)(D) to (H). Pub. L. 106–554 added subpar. (D) identical to that added by Pub. L. 106–505 and redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to director and such other staff obtaining organs from donors in its service area. Additional amendment directing realignment of margin of subpar. (F) could not be executed after amendment by Pub. L. 106–505.
Pub. L. 106–505 added subpar. (D), redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to board of directors or advisory board, and realigned margin of subpar. (F).
1990
Pub. L. 101–616, § 201(a), substituted “Organ procurement organizations” for “Assistance for organ procurement organizations” in section catchline.
Subsec. (a)(3). Pub. L. 101–616, § 201(b)(1), substituted “may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects” for “may make grants for special projects”.
Subsec. (a)(4). Pub. L. 101–616, § 201(b)(2), struck out par. (4) which set forth factors to consider in making grants.
Subsec. (b)(1)(E). Pub. L. 101–616, § 201(c)(1), amended subpar. (E) generally. Prior to amendment, subpar. (E) read as follows: “has a defined service area which is a geographical area of sufficient size such that (unless the service area comprises an entire State) the organization can reasonably expect to procure organs from not less than 50 donors each year and which either includes an entire standard metropolitan statistical area (as specified by the Office of Management and Budget) or does not include any part of such an area,”.
Subsec. (b)(1)(G)(i)(III). Pub. L. 101–616, § 201(e), made technical correction to Pub. L. 100–607, § 402(c)(2). See 1988 Amendment note below.
Subsec. (b)(2), (3). Pub. L. 101–616, § 201(d), added par. (2) and redesignated former par. (2) as (3).
Subsec. (c). Pub. L. 101–616, § 206(b), struck out subsec. (c) which authorized appropriations for subsec. (a) grants for fiscal years 1988 through 1990.
1988
Subsec. (a)(2). Pub. L. 100–607, § 402(a)(1), inserted “consolidation,” after “initial operation,”.
Subsec. (a)(3). Pub. L. 100–607, § 402(a)(2), added par. (3). Former par. (3) redesignated (4).
Subsec. (a)(4). Pub. L. 100–607, § 402(a)(2), redesignated former par. (3) as (4).
Subsec. (a)(4)(C). Pub. L. 100–607, § 402(a)(3), added subpar. (C).
Subsec. (b)(1)(E). Pub. L. 100–607, § 402(c)(1)(A), substituted “size such that” for “size which”, and “the organization can reasonably expect to procure organs from not less than 50 donors each year” for “will include at least fifty potential organ donors each year”.
Subsec. (b)(1)(G)(i)(III). Pub. L. 100–607, § 402(c)(2), as amended by Pub. L. 101–616, § 201(e), inserted “or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility” before comma at end.
Subsec. (b)(2)(C). Pub. L. 100–607, § 402(c)(1)(B), substituted “274(b)(2)(E) of this title, including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,” for “274(b)(2)(D) of this title,”.
Subsec. (b)(2)(E). Pub. L. 100–607, § 402(c)(1)(C), substituted “organs equitably among transplant patients” for “organs among transplant centers and patients”.
Subsec. (b)(2)(K). Pub. L. 100–607, § 402(c)(1)(D), added subpar. (K).
Subsec. (c). Pub. L. 100–607, § 402(d), amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: “For grants under subsection (a) of this section there are authorized to be appropriated $5,000,000 for fiscal year 1985, $8,000,000 for fiscal year 1986, and $12,000,000 for fiscal year 1987.”
Statutory Notes and Related Subsidiaries
Effective Date of 1990 Amendment
Pub. L. 101–616, title II, § 207, , 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on , or on the date of the enactment of this Act [], whichever occurs later.”
Effective Date of 1988 Amendment
Pub. L. 100–607, title IV, § 402(c)(3), , 102 Stat. 3115, as amended by Pub. L. 101–274, , 104 Stat. 139, which provided that the amendment made by section 402(c)(1)(A) of Pub. L. 100–607, amending this section, was not to apply to an organ procurement organization designated under section 1320b–8(b) of this title until , was repealed by Pub. L. 101–616, title II, § 201(c)(2), , 104 Stat. 3283.
Short Title
For short title of Pub. L. 98–507, which enacted this part as the “National Organ Transplant Act”, see section 1 of Pub. L. 98–507, set out as a Short Title of 1984 Amendments note under section 201 of this title.
Severability
Pub. L. 101–616, title III, § 301, , 104 Stat. 3286, provided that: “If any provision of this Act [enacting sections 274f, 274g, 274k, and 274l of this title, amending this section and sections 274 to 274d of this title, enacting provisions set out as notes under this section and sections 274 and 274k of this title, and repealing provisions set out as a note above], amendment made by this Act, or application of the provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions or amendments to any person or circumstance shall not be affected.”
Certification of Organ Procurement Organizations
Pub. L. 106–505, title VII, § 701(b), , 114 Stat. 2346, and Pub. L. 106–554, § 1(a)(1) [title II, § 219(a)], , 114 Stat. 2763, 2763A–28, provided that:
“Congress makes the following findings:
“(1) Organ procurement organizations play an important role in the effort to increase organ donation in the United States.
“(2) The current process for the certification and recertification of organ procurement organizations conducted by the Department of Health and Human Services has created a level of uncertainty that is interfering with the effectiveness of organ procurement organizations in raising the level of organ donation.
“(3) The General Accounting Office [now Government Accountability Office], the Institute of Medicine, and the Harvard School of Public Health have identified substantial limitations in the organ procurement organization certification and recertification process and have recommended changes in that process.
“(4) The limitations in the recertification process include:
“(A) An exclusive reliance on population-based measures of performance that do not account for the potential in the population for organ donation and do not permit consideration of other outcome and process standards that would more accurately reflect the relative capability and performance of each organ procurement organization.
“(B) A lack of due process to appeal to the Secretary of Health and Human Services for recertification on either substantive or procedural grounds.
“(5) The Secretary of Health and Human Services has the authority under section 1138(b)(1)(A)(i) of the Social Security Act (42 U.S.C. 1320b–8(b)(1)(A)(i)) to extend the period for recertification of an organ procurement organization from 2 to 4 years on the basis of its past practices in order to avoid the inappropriate disruption of the nation’s organ system.
“(6) The Secretary of Health and Human Services can use the extended period described in paragraph (5) for recertification of all organ procurement organizations to—
“(A) develop improved performance measures that would reflect organ donor potential and interim outcomes, and to test these measures to ensure that they accurately measure performance differences among the organ procurement organizations; and
“(B) improve the overall certification process by incorporating process as well as outcome performance measures, and developing equitable processes for appeals.”
Study Regarding Immunosuppressive Drugs
Pub. L. 106–310, div. A, title XXI, § 2101(b), , 114 Stat. 1156, required the Secretary of Health and Human Services to provide for a study to determine the costs of immunosuppressive drugs provided to children pursuant to organ transplants and to determine the extent to which health plans and health insurance covered such costs, and related issues, and to submit the report to Congress by .
Study on Hospital Agreements With Organ Procurement Agencies
Pub. L. 103–432, title I, § 155(b), , 108 Stat. 4439, directed Office of Technology Assessment to conduct study to determine efficacy and fairness of requiring a hospital to enter into agreement under subsec. (b)(3)(A) of this section with organ procurement agency for service area in which such hospital is located and impact of such requirement on efficacy and fairness of organ procurement and distribution, and to submit to Congress, not later than 2 years after , report containing findings of such study and implications of such findings with respect to policies affecting organ procurement and distribution.
Task Force on Organ Procurement and Transplantation
Pub. L. 98–507, title I, §§ 101–105, , 98 Stat. 2339–2342, directed Secretary of Health and Human Services, not later than 90 days after , to establish a Task Force on Organ Transplantation to conduct comprehensive examinations, prepare an assessment and report, and submit advice as to regulation of the medical, legal, ethical, economic, and social issues presented by human organ procurement and transplantation, with the final report due not later than 12 months after the Task Force is established and the Task Force to terminate 3 months thereafter.
Bone Marrow Registry Demonstration and Study
Pub. L. 98–507, title IV, § 401, , 98 Stat. 3268, directed Secretary of Health and Human Services to hold a conference on the feasibility of establishing and the effectiveness of a national registry of voluntary bone marrow donors not later than 9 months after , and if the conference found that it was feasible to establish a national registry of voluntary donors of bone marrow and that such a registry was likely to be effective in matching donors with recipients, the Secretary was to establish a registry of voluntary donors of bone marrow not later than six months after the completion of the conference, and further directed the Secretary, acting through the Assistant Secretary for Health, to study the establishment and implementation of the registry to identify the issues presented by the establishment of such a registry, to evaluate participation of bone marrow donors, to assess the implementation of the informed consent and confidentiality requirements, and to determine if the establishment of a permanent bone marrow registry was needed and appropriate, and to report the results of the study to Congress not later than two years after the date the registry was established.
Credits
1944–2023 · 9 acts
- 1944July 1, 1944, ch. 373, title III, § 371, as added Pub. L. 98–507, title II, § 201, , 98 Stat. 2342
- 1988amended Pub. L. 100–607, title IV, § 402(a), (c)(1), (2), (d), , 102 Stat. 3114, 3115
- 1990Pub. L. 101–616, title II, §§ 201(a)–(c)(1), (d), (e), 206(b), , 104 Stat. 3283, 3285
- 2000Pub. L. 106–505, title VII, § 701(c), , 114 Stat. 2347
- 2000Pub. L. 106–554, § 1(a)(1) [title II, § 219(b)], , 114 Stat. 2763, 2763A–29
- 2004Pub. L. 108–216, § 9, , 118 Stat. 590
- 2004Pub. L. 108–362, § 2, , 118 Stat. 1703
- 2013Pub. L. 113–51, § 2(a)(2), (3), , 127 Stat. 579, 580
- 2023Pub. L. 118–14, § 3(1), , 137 Stat. 69.
Show as published
(July 1, 1944, ch. 373, title III, § 371, as added Pub. L. 98–507, title II, § 201, , 98 Stat. 2342; amended Pub. L. 100–607, title IV, § 402(a), (c)(1), (2), (d), , 102 Stat. 3114, 3115; Pub. L. 101–616, title II, §§ 201(a)–(c)(1), (d), (e), 206(b), , 104 Stat. 3283, 3285; Pub. L. 106–505, title VII, § 701(c), , 114 Stat. 2347; Pub. L. 106–554, § 1(a)(1) [title II, § 219(b)], , 114 Stat. 2763, 2763A–29; Pub. L. 108–216, § 9, , 118 Stat. 590; Pub. L. 108–362, § 2, , 118 Stat. 1703; Pub. L. 113–51, § 2(a)(2), (3), , 127 Stat. 579, 580; Pub. L. 118–14, § 3(1), , 137 Stat. 69.)