42 U.S.C. § 273b — Report on the long-term health effects of

Page 507 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 273b title until Jan. 1, 1992, was repealed by Pub. L. 101–616, title II, § 201(c)(2), Nov. 16, 1990, 104 Stat. 3283. SHORT TITLE For short title of Pub. L. 98–507, which enacted this part as the ‘‘National Organ Transplant Act’’, see sec- tion 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, Nov. 16, 1990, 104 Stat. 3286, provided that: ‘‘If any provision of this Act [enact- ing 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 re- pealing 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 cir- cumstance shall not be affected.’’ CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS Pub. L. 106–505, title VII, § 701(b), Nov. 13, 2000, 114 Stat. 2346, and Pub. L. 106–554, § 1(a)(1) [title II, § 219(a)], Dec. 21, 2000, 114 Stat. 2763, 2763A–28, provided that: ‘‘Congress makes the following findings: ‘‘(1) Organ procurement organizations play an im- portant 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 procure- ment organizations in raising the level of organ dona- tion. ‘‘(3) The General Accounting Office [now Govern- ment Accountability Office], the Institute of Medi- cine, and the Harvard School of Public Health have identified substantial limitations in the organ pro- curement organization certification and recertifi- cation 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 Sec- retary of Health and Human Services for recertifi- cation 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 pro- curement organization from 2 to 4 years on the basis of its past practices in order to avoid the inappro- priate 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 organiza- tions to— ‘‘(A) develop improved performance measures that would reflect organ donor potential and in- terim outcomes, and to test these measures to en- sure that they accurately measure performance dif- ferences among the organ procurement organiza- tions; and ‘‘(B) improve the overall certification process by incorporating process as well as outcome perform- ance measures, and developing equitable processes for appeals.’’ STUDY REGARDING IMMUNOSUPPRESSIVE DRUGS Pub. L. 106–310, div. A, title XXI, § 2101(b), Oct. 17, 2000, 114 Stat. 1156, required the Secretary of Health and Human Services to provide for a study to deter- mine the costs of immunosuppressive drugs provided to children pursuant to organ transplants and to deter- mine the extent to which health plans and health in- surance covered such costs, and related issues, and to submit the report to Congress by Dec. 31, 2001. STUDY ON HOSPITAL AGREEMENTS WITH ORGAN PROCUREMENT AGENCIES Pub. L. 103–432, title I, § 155(b), Oct. 31, 1994, 108 Stat. 4439, directed Office of Technology Assessment to con- duct study to determine efficacy and fairness of requir- ing 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 Oct. 31, 1994, re- port 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, Oct. 19, 1984, 98 Stat. 2339–2342, directed Secretary of Health and Human Services, not later than 90 days after Oct. 19, 1984, to es- tablish a Task Force on Organ Transplantation to con- duct comprehensive examinations, prepare an assess- ment and report, and submit advice as to regulation of the medical, legal, ethical, economic, and social issues presented by human organ procurement and transplan- tation, 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, Oct. 19, 1984, 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 vol- untary bone marrow donors not later than 9 months after Oct. 19, 1984, and if the conference found that it was feasible to establish a national registry of vol- untary donors of bone marrow and that such a registry was likely to be effective in matching donors with re- cipients, 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 fur- ther directed the Secretary, acting through the Assist- ant Secretary for Health, to study the establishment and implementation of the registry to identify the issues presented by the establishment of such a reg- istry, 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 reg- istry was needed and appropriate, and to report the re- sults of the study to Congress not later than two years after the date the registry was established. § 273a. National living donor mechanisms The Secretary may establish and maintain mechanisms to evaluate the long-term effects associated with living organ donations by indi- viduals who have served as living donors. (July 1, 1944, ch. 373, title III, § 371A, as added Pub. L. 108–216, § 7, Apr. 5, 2004, 118 Stat. 589.) § 273b. Report on the long-term health effects of living organ donation Not later than 1 year after December 21, 2007, and annually thereafter, the Secretary of Health Page 508 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274 and Human Services shall submit to the appro- priate committees of Congress a report that de- tails the progress made towards understanding the long-term health effects of living organ do- nation. (Pub. L. 110–144, § 3, Dec. 21, 2007, 121 Stat. 1814.) Editorial Notes CODIFICATION Section was enacted as part of the Charlie W. Nor- wood Living Organ Donation Act, and not as part of the Public Health Service Act which comprises this chap- ter. § 274. Organ procurement and transplantation network (a) In general The Secretary shall provide for the continued operation of an Organ Procurement and Trans- plantation Network which meets the require- ments of subsection (b). The Secretary may award grants, contracts, or cooperative agree- ments, as the Secretary determines appropriate, for purposes of carrying out this section. (b) Composition (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 orga- nizations that have received grants under section 273 of this title), transplant centers, voluntary health associations, and the gen- eral public; and (ii) that shall establish an executive com- mittee and other committees, whose chair- persons shall be selected to ensure con- tinuity of leadership for the board. (2) The Organ Procurement and Transplan- tation Network shall— (A) establish in one location or through re- gional centers— (i) a national list of individuals who need organs, and (ii) a national system, through the use of computers and in accordance with estab- lished 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 med- ical 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 in- dividuals included in the list, (D) assist organ procurement organizations in the nationwide distribution of organs equi- tably 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 transpor- tation of organs from organ procurement orga- nizations to transplant centers, (H) provide information to physicians and other health professionals regarding organ do- nation, (I) collect, analyze, and publish data con- cerning organ donation and transplants, (J) carry out studies and demonstration projects for the purpose of improving proce- dures 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 chil- dren and adults throughout the system and adopt criteria, polices, and procedures that ad- dress the unique health care needs of children, (N) carry out studies and demonstration projects for the purpose of improving proce- dures for organ donation procurement and al- location, including but not limited to projects to examine and attempt to increase transplan- tation 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 para- graph, the term ‘‘children’’ refers to individ- uals 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 Net- work may adopt and use such standards with re- spect to organs infected with human immuno- deficiency virus (in this paragraph referred to as ‘‘HIV’’), provided that any such standards en- sure 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 274f–5 of this title; or (ii) if the Secretary has determined under section 274f–5(c) of this title 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 274f–5(c) of this title. (c) Consideration of critical comments The Secretary shall establish procedures for— (1) receiving from interested persons critical comments relating to the manner in which the