Story Transcript
TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− Sec. 300cc−11. Clinical evaluation units at National Institutes of Health −STATUTE− (a) In general The Secretary, acting through the Director of the National Cancer Institute and the Director of the National Institute of Allergy and Infectious Diseases, shall for each such Institute establish a clinical evaluation unit at the Clinical Center at the National Institutes of Health. Each of the clinical evaluation units − (1) shall conduct clinical evaluations of experimental treatments for acquired immune deficiency syndrome developed within the preclinical drug development program, including evaluations of methods of diagnosing immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases; and (2) may conduct clinical evaluations of experimental treatments for such syndrome that are developed by any other national research institute of the National Institutes of Health or by any other entity.
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(b) Personnel and administrative support (1) For the purposes described in subsection (a) of this section, the Secretary, acting through the Director of the National Institutes of Health, shall provide each of the clinical evaluation units required in such subsection − (A)(i) with not less than 50 beds; or (ii) with an outpatient clinical capacity equal to not less than twice the outpatient clinical capacity, with respect to acquired immune deficiency syndrome, possessed by the Clinical Center of the National Institutes of Health on June 1, 1988; and (B) with such personnel, such administrative support, and such other support services as may be necessary. (2) Facilities, personnel, administrative support, and other support services provided pursuant to paragraph (1) shall be in addition to the number or level of facilities, personnel, administrative support, and other support services that otherwise would be available at the Clinical Center at the National Institutes of Health for the provision of clinical care for individuals with diseases or disorders. (c) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2311, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3066; amended Pub. L. 103−43, title XVIII, Sec. 1811(2), June 10,
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1993,107 Stat. 199.) −MISC1− PRIOR PROVISIONS A prior section 300cc−11, act July 1, 1944, Sec. 2312, was successively renumbered by subsequent acts and transferred, see section 238i of this title. AMENDMENTS 1993 − Subsec. (a)(1). Pub. L. 103−43 inserted before semicolon at end ", including evaluations of methods of diagnosing immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases". −End− −CITE− 42 USC Sec. 300cc−12 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− Sec. 300cc−12. Use of investigational new drugs with respect to acquired immune deficiency syndrome −STATUTE− (a) Encouragement of applications with respect to clinical trials
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(1) If, in the determination of the Secretary, there is preliminary evidence that a new drug has effectiveness in humans with respect to the prevention or treatment of acquired immune deficiency syndrome, the Secretary shall, through statements published in the Federal Register − (A) announce the fact of such determination; and (B) with respect to the new drug involved, encourage an application for an exemption for investigational use of the new drug under regulations issued under section 355(i) of title 21. (2)(A) The AIDS Research Advisory Committee established pursuant to section 300cc−3 of this title shall make recommendations to the Secretary with respect to new drugs appropriate for determinations described in paragraph (1). (B) The Secretary shall, as soon as is practicable, determine the merits of recommendations received by the Secretary pursuant to subparagraph (A). (b) Encouragement of applications with respect to treatment use in circumstances other than clinical trials (1) In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a) of this section and with respect to which an exemption is in effect for purposes of section 355(i) of title 21, the Secretary shall − (A) as appropriate, encourage the sponsor of the investigation of the new drug to submit to the Secretary, in accordance with regulations issued under such section, an application to use the drug in the treatment of individuals −
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(i) who are infected with the etiologic agent for acquired immune deficiency syndrome; and (ii) who are not participating in the clinical trials conducted pursuant to such exemption; and (B) if such an application is approved, encourage, as appropriate, licensed medical practitioners to obtain, in accordance with such regulations, the new drug from such sponsor for the purpose of treating such individuals. (2) If the sponsor of the investigation of a new drug described in paragraph (1) does not submit to the Secretary an application described in such paragraph (relating to treatment use), the Secretary shall, through statements published in the Federal Register, encourage, as appropriate, licensed medical practitioners to submit to the Secretary such applications in accordance with regulations described in such paragraph. (c) Technical assistance with respect to treatment use In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a) of this section, the Secretary may, directly or through grants or contracts, provide technical assistance with respect to the process of − (1) submitting to the Secretary applications for exemptions described in paragraph (1)(B) of such subsection; (2) submitting to the Secretary applications described in subsection (b) of this section; and (3) with respect to sponsors of investigations of new drugs, facilitating the transfer of new drugs from such sponsors to
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licensed medical practitioners. (d) "New drug" defined For purposes of this section, the term "new drug" has the meaning given such term in section 321 of title 21. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2312, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3066; amended Pub. L. 103−43, title XX, Sec. 2008(d)(2), June 10, 1993, 107 Stat. 212.) −MISC1− PRIOR PROVISIONS A prior section 300cc−12, act July 1, 1944, Sec. 2313, was successively renumbered by subsequent acts and transferred, see section 238j of this title. AMENDMENTS 1993 − Subsec. (a)(2)(A). Pub. L. 103−43 substituted "AIDS Research Advisory Committee" for "AIDS Clinical Research Review Committee". −End− −CITE− 42 USC Sec. 300cc−13 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME
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Part B − Research Authority −HEAD− Sec. 300cc−13. Terry Beirn Community−Based AIDS Research Initiative −STATUTE− (a) In general After consultation with the Commissioner of Food and Drugs, the Director of the National Institutes of Health, acting through the Director of the National Institute of Allergy and Infectious Diseases, may make grants to public entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into contracts with public and private such (!1) entities, for the purpose of planning and conducting, in the community involved, clinical trials of experimental treatments for infection with the etiologic agent for such syndrome that are approved by the Commissioner of Food and Drugs for investigational use under regulations issued under section 355 of title 21. (b) Requirement of certain projects (1) Financial assistance under subsection (a) of this section shall include such assistance to community−based organizations and community health centers for the purpose of − (A) retaining appropriate medical supervision; (B) assisting with administration, data collection and record management; and (C) conducting training of community physicians, nurse practitioners, physicians' assistants and other health professionals for the purpose of conducting clinical trials.
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(2)(A) Financial assistance under subsection (a) of this section shall include such assistance for demonstration projects designed to implement and conduct community−based clinical trials in order to provide access to the entire scope of communities affected by infections with the etiologic agent for acquired immune deficiency syndrome, including minorities, hemophiliacs and transfusion−exposed individuals, women, children, users of intravenous drugs, and individuals who are asymptomatic with respect to such infection. (B) The Director of the National Institutes of Health may not provide financial assistance under this paragraph unless the application for such assistance is approved − (i) by the Commissioner of Food and Drugs; (ii) by a duly constituted Institutional Review Board that meets the requirements of part 56 of title 21, Code of Federal Regulations; and (iii) by the Director of the National Institute of Allergy and Infectious Diseases. (c) Participation of private industry, schools of medicine and primary providers Programs carried out with financial assistance provided under subsection (a) of this section shall be designed to encourage private industry and schools of medicine, osteopathic medicine, and existing consortia of primary care providers organized to conduct clinical research concerning acquired immune deficiency syndrome to participate in, and to support, the clinical trials conducted
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pursuant to the programs. (d) Requirement of application The Secretary may not provide financial assistance under subsection (a) of this section unless − (1) an application for the assistance is submitted to the Secretary; (2) with respect to carrying out the purpose for which the assistance is to be made, the application provides assurances of compliance satisfactory to the Secretary; and (3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. (e) Authorization of appropriations (1) For the purpose of carrying out subsection (b)(1) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1996. (2) For the purpose of carrying out subsection (b)(2) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1996. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2313, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3068; amended Pub. L. 100−690, title II, Sec. 2617(b), Nov. 18, 1988, 102 Stat. 4240; Pub. L. 101−93, Sec. 6, Aug. 16, 1989, 103 Stat. 615; Pub. L. 102−96, Sec. 3, Aug. 14, 1991, 105 Stat. 481.)
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−MISC1− PRIOR PROVISIONS A prior section 300cc−13, act July 1, 1944, Sec. 2314, was successively renumbered by subsequent acts and transferred, see section 238k of this title. AMENDMENTS 1991 − Pub. L. 102−96, Sec. 3(1), substituted "Terry Beirn Community−Based AIDS Research Initiative" for "Community−based evaluations of experimental therapies" in section catchline. Subsec. (c). Pub. L. 102−96, Sec. 3(2), substituted ", schools of medicine and primary providers" for "and schools of medicine" in heading and substituted "schools of medicine, osteopathic medicine, and existing consortia of primary care providers organized to conduct clinical research concerning acquired immune deficiency syndrome" for "schools of medicine and osteopathic medicine". Subsec. (e). Pub. L. 102−96, Sec. 3(3), substituted "1996" for "1991" in pars. (1) and (2). 1989 − Subsec. (c). Pub. L. 101−93 inserted "and osteopathic medicine" after "schools of medicine". 1988 − Subsec. (a). Pub. L. 100−690, Sec. 2617(b)(1), which directed substitution of "through the Director of the National Institute of Allergy" for "through the National Institutes of Allergy", was executed by making substitution for "through the National Institute of Allergy" as the probable intent of Congress. Subsec. (b)(2)(B)(iii). Pub. L. 100−690, Sec. 2617(b)(2), which directed substitution of "Institute" for "Institutes", could not be
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executed because "Institute" was singular in original. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING, OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER Reference to community health center, migrant health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104−299, set out as a note under section 254b of this title. FINDINGS AND SENSE OF CONGRESS Section 2 of Pub. L. 102−96 provided that: "(a) Findings. − Congress finds that − "(1) community−based clinical trials complement the National Institute of Allergy and Infectious Diseases' university−based research in order to provide increased access to experimental therapies; "(2) community−based clinical trials provide an efficient and cost−effective means to develop new HIV−related treatments, benefiting all people living with HIV disease and other illnesses; and "(3) because the community−based clinical trials model has a proven ability to conduct rapid trials that meet the very highest standards of scientific inquiry, this program should be
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reauthorized and significantly expanded. "(b) Sense of Congress. − It is the sense of Congress that, because of Terry Beirn's tireless efforts to foster a partnership among all parties invested in AIDS research (including the National Institutes of Health university−based research system, primary care physicians practicing in the community, and patients), the community−based clinical trials program should be renamed as the 'Terry Beirn Community−Based AIDS Research Initiative' in his honor." −FOOTNOTE− (!1) So in original. −End− −CITE− 42 USC Sec. 300cc−14 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− Sec. 300cc−14. Evaluation of certain treatments −STATUTE− (a) Establishment of program (1) After consultation with the AIDS Research Advisory Committee established pursuant to section 300cc−3 of this title, the
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Secretary shall establish a program for the evaluation of drugs that − (A) are not approved by the Commissioner of Food and Drugs for the purpose of treatments with respect to acquired immune deficiency syndrome; and (B) are being utilized for such purpose by individuals infected with the etiologic agent for such syndrome. (2) The program established under paragraph (1) shall include evaluations of the effectiveness and the risks of the treatment involved, including the risks of foregoing treatments with respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and Drugs. (b) Authority with respect to grants and contracts (1) For the purpose of conducting evaluations required in subsection (a) of this section, the Secretary may make grants to, and enter into cooperative agreements and contracts with, public and nonprofit private entities. (2) Nonprofit private entities under paragraph (1) may include nonprofit private organizations that − (A) are established for the purpose of evaluating treatments with respect to acquired immune deficiency syndrome; and (B) consist primarily of individuals infected with the etiologic agent for such syndrome. (c) Scientific and ethical guidelines (1) The Secretary shall establish appropriate scientific and ethical guidelines for the conduct of evaluations carried out
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pursuant to this section. The Secretary may not provide financial assistance under subsection (b)(1) of this section unless the applicant for such assistance agrees to comply with such guidelines. (2) The Secretary may establish the guidelines described in paragraph (1) only after consulting with − (A) physicians whose clinical practice includes a significant number of individuals with acquired immune deficiency syndrome; (B) individuals who are infected with the etiologic agent for such syndrome; and (C) other individuals with appropriate expertise or experience. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2314, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3069; amended Pub. L. 103−43, title XX, Sec. 2008(d)(3), June 10, 1993, 107 Stat. 212.) −MISC1− PRIOR PROVISIONS A prior section 300cc−14, act July 1, 1944, Sec. 2315, was successively renumbered by subsequent acts and transferred, see section 238l of this title. AMENDMENTS 1993 − Subsec. (a)(1). Pub. L. 103−43 substituted "AIDS Research
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Advisory Committee" for "Clinical Research Review Committee" in introductory provisions. −End− −CITE− 42 USC Sec. 300cc−15 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− Sec. 300cc−15. Support of international efforts −STATUTE− (a) Grants and contracts for research (1) Under section 242l of this title, the Secretary, acting through the Director of the National Institutes of Health − (A) shall, for the purpose described in paragraph (2), make grants to, enter into cooperative agreements and contracts with, and provide technical assistance to, international organizations concerned with public health; and (B) may, for such purpose, provide technical assistance to foreign governments. (2) The purpose referred to in paragraph (1) is promoting and expediting international research and training concerning the natural history and pathogenesis of the human immunodeficiency
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virus and the development and evaluation of vaccines and treatments for acquired immune deficiency syndrome and opportunistic infections. (b) Grants and contracts for additional purposes After consultation with the Administrator of the Agency for International Development, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall under section 242l of this title make grants to, enter into contracts with, and provide technical assistance to, international organizations concerned with public health and may provide technical assistance to foreign governments, in order to support − (1) projects for training individuals with respect to developing skills and technical expertise for use in the prevention, diagnosis, and treatment of acquired immune deficiency syndrome; and (2) epidemiological research relating to acquired immune deficiency syndrome. (c) Special Programme of World Health Organization Support provided by the Secretary pursuant to this section shall be in furtherance of the global strategy of the World Health Organization Special Programme on Acquired Immunodeficiency Syndrome. (d) Preferences In providing grants, cooperative agreements, contracts, and technical assistance under subsections (a) and (b) of this section, the Secretary shall −
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(1) give preference to activities under such subsections conducted by, or in cooperation with, the World Health Organization; and (2) with respect to activities carried out under such subsections in the Western Hemisphere, give preference to activities conducted by, or in cooperation with, the Pan American Health Organization or the World Health Organization. (e) Requirement of application The Secretary may not make a grant or enter into a cooperative agreement or contract under this section unless − (1) an application for such assistance is submitted to the Secretary; (2) with respect to carrying out the purpose for which such assistance is to be provided, the application provides assurances of compliance satisfactory to the Secretary; and (3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. (f) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each fiscal year. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2315, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3070;
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amended Pub. L. 102−531, title III, Sec. 312(d)(18), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103−43, title XVIII, Sec. 1811(3), June 10, 1993, 107 Stat. 199.) −MISC1− PRIOR PROVISIONS A prior section 300cc−15, act July 1, 1944, Sec. 2316, was successively renumbered by subsequent acts and transferred, see section 238m of this title. AMENDMENTS 1993 − Subsec. (a)(2). Pub. L. 103−43, Sec. 1811(3)(A), substituted "international research and training concerning the natural history and pathogenesis of the human immunodeficiency virus and the development and evaluation of vaccines and treatments for acquired immune deficiency syndrome and opportunistic infections" for "international research concerning the development and evaluation of vaccines and treatments for acquired immune deficiency syndrome". Subsec. (f). Pub. L. 103−43, Sec. 1811(3)(B), substituted "such sums as may be necessary for each fiscal year" for "there are authorized to be appropriated $40,000,000 for fiscal year 1989 and such sums as may be necessary for each of the fiscal years 1990 and 1991". 1992 − Subsec. (b). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". −End− −CITE−
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42 USC Sec. 300cc−16 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− Sec. 300cc−16. Research centers −STATUTE− (a) In general (1) The Secretary, acting through the Director of the National Institute of Allergy and Infectious Diseases, may make grants to, and enter into contracts with, public and nonprofit private entities to assist such entities in planning, establishing, or strengthening, and providing basic operating support for, centers for basic and clinical research into, and training in, advanced diagnostic, prevention, and treatment methods for acquired immune deficiency syndrome. (2) A grant or contract under paragraph (1) shall be provided in accordance with policies established by the Secretary, acting through the Director of the National Institutes of Health, and after consultation with the advisory council for the National Institute of Allergy and Infectious Diseases. (3) The Secretary shall ensure that, as appropriate, clinical research programs carried out under paragraph (1) include as
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research subjects women, children, hemophiliacs, and minorities. (b) Use of financial assistance (1) Financial assistance under subsection (a) of this section may be expended for − (A) the renovation or leasing of space; (B) staffing and other basic operating costs, including such patient care costs as are required for clinical research; (C) clinical training with respect to acquired immune deficiency syndrome (including such training for allied health professionals); and (D) demonstration purposes, including projects in the long−term monitoring and outpatient treatment of individuals infected with the etiologic agent for such syndrome. (2) Financial assistance under subsection (a) of this section may not be expended to provide research training for which Ruth L. Kirschstein National Research Service Awards may be provided under section 288 of this title. (c) Duration of support Support of a center under subsection (a) of this section may be for not more than five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. (d) Authorization of appropriations
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For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2316, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3071; amended Pub. L. 107−206, title I, Sec. 804(c), Aug. 2, 2002, 116 Stat. 874.) −MISC1− AMENDMENTS 2002 − Subsec. (b)(2). Pub. L. 107−206 substituted "Ruth L. Kirschstein National Research Service Awards" for "National Research Service Awards". −End− −CITE− 42 USC Sec. 300cc−17 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− Sec. 300cc−17. Information services −STATUTE− (a) Establishment of program The Secretary shall establish, maintain, and operate a program
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with respect to information on research, treatment, and prevention activities relating to infection with the etiologic agent for acquired immune deficiency syndrome. The program shall, with respect to the agencies of the Department of Health and Human Services, be integrated and coordinated. (b) Toll−free telephone communications for health care entities (1) After consultation with the Director of the Office of AIDS Research, the Administrator of the Health Resources and Services Administration, and the Director of the Centers for Disease Control and Prevention, the Secretary shall provide for toll−free telephone communications to provide medical and technical information with respect to acquired immune deficiency syndrome to health care professionals, allied health care providers, and to professionals providing emergency health services. (2) Information provided pursuant to paragraph (1) shall include − (A) information on prevention of exposure to, and the transmission of, the etiologic agent for acquired immune deficiency syndrome; and (B) information contained in the data banks established in subsections (c) and (d) of this section. (c) Data bank on research information (1) After consultation with the Director of the Office of AIDS Research, the Director of the Centers for Disease Control and Prevention, and the National Library of Medicine, the Secretary shall establish a data bank of information on the results of
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research with respect to acquired immune deficiency syndrome conducted in the United States and other countries. (2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. To the extent practicable, the Secretary shall make such information available to researchers, physicians, and other appropriate individuals, of countries other than the United States. (d) Data bank on clinical trials and treatments (1) After consultation with the Commissioner of Food and Drugs, the AIDS Research Advisory Committee established under section 300cc−3 of this title, and the Director of the Office of AIDS Research, the Secretary shall, in carrying out subsection (a) of this section, establish a data bank of information on clinical trials and treatments with respect to infection with the etiologic agent for acquired immune deficiency syndrome (hereafter in this section referred to as the "Data Bank"). (2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems available to individuals infected with the etiologic agent for acquired immune deficiency syndrome, to other members of the public, to health care providers, and to researchers. (e) Requirements with respect to data bank on clinical trials and treatments The Data Bank shall include the following:
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(1) A registry of clinical trials of experimental treatments for acquired immune deficiency syndrome and related illnesses conducted under regulations promulgated pursuant to section 355 of title 21 that provides a description of the purpose of each experimental drug protocol either with the consent of the protocol sponsor, or when a trial to test efficacy begins. Information provided shall include eligibility criteria and the location of trial sites, and must be forwarded to the Data Bank by the sponsor of the trial not later than 21 days after the approval by the Food and Drug Administration. (2) Information pertaining to experimental treatments for acquired immune deficiency syndrome that may be available under a treatment investigational new drug application that has been submitted to the Food and Drug Administration pursuant to part 312 of title 21, Code of Federal Regulations. The Data Bank shall also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, of such experimental treatments, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatment. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2317, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3071; amended Pub. L. 100−690, title II, Sec. 2617(c), Nov. 18, 1988, 102 Stat. 4240; Pub. L. 102−531, title III, Sec. 312(d)(19), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103−43, title XX, Sec. 2008(d)(4),
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June 10, 1993, 107 Stat. 212.) −MISC1− AMENDMENTS 1993 − Subsec. (d)(1). Pub. L. 103−43 substituted "AIDS Research Advisory Committee established under section 300cc−3 of this title" for "Clinical Research Review Committee". 1992 − Subsecs. (b)(1), (c)(1). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". 1988 − Subsec. (e). Pub. L. 100−690 substituted "data bank on clinical trials and treatments" for "data bank" in heading. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −End− −CITE− 42 USC Sec. 300cc−18 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD−
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Sec. 300cc−18. Development of model protocols for clinical care of infected individuals −STATUTE− (a) In general (1) The Secretary, acting through the Director of the National Institutes of Health and after consultation with the Director of the Agency for Healthcare Research and Quality, may make grants to public and nonprofit private entities for the establishment of projects to develop model protocols for the clinical care of individuals infected with the etiologic agent for acquired immune deficiency syndrome, including treatment and prevention of HIV infection and related conditions among women. (2) The Secretary may not make a grant under paragraph (1) unless − (A) the applicant for the grant is a provider of comprehensive primary care; or (B) the applicant for the grant agrees, with respect to the project carried out pursuant to paragraph (1), to enter into a cooperative arrangement with an entity that is a provider of comprehensive primary care. (b) Requirement of provision of certain services The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees that, with respect to patients participating in the project carried out with the grant, services provided pursuant to the grant will include − (1) monitoring, in clinical laboratories, of the condition of
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such patients; (2) clinical intervention for infection with the etiologic agent for acquired immune deficiency syndrome, including measures for the prevention of conditions arising from the infection; (3) information and counseling on the availability of treatments for such infection approved by the Commissioner of Food and Drugs, on the availability of treatments for such infection not yet approved by the Commissioner, and on the reports issued by the AIDS Research Advisory Committee under section 300cc−3(c)(2)(B) of this title; (4) support groups; and (5) information on, and referrals to, entities providing appropriate social support services. (c) Limitation on imposition of charges for services The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees that, if the applicant will routinely impose a charge for providing services pursuant to the grant, the applicant will not impose the charge on any individual seeking such services who is unable to pay the charge. (d) Evaluation and reports (1) The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees, with respect to the project carried out pursuant to subsection (a) of this section, to submit to the Secretary − (A) information sufficient to assist in the replication of the
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model protocol developed pursuant to the project; and (B) such reports as the Secretary may require. (2) The Secretary shall provide for evaluations of projects carried out pursuant to subsection (a) of this section and shall annually submit to the Congress a report describing such projects. The report shall include the findings made as a result of such evaluations and may include any recommendations of the Secretary for appropriate administrative and legislative initiatives with respect to the program established in this section. (e) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991, and such sums as may be necessary for each of the fiscal years 1994 through 1996. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2318, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3073; amended Pub. L. 103−43, title XVIII, Sec. 1811(4), title XX, Sec. 2008(d)(5), June 10, 1993, 107 Stat. 199, 212; Pub. L. 106−129, Sec. 2(b)(2), Dec. 6, 1999, 113 Stat. 1670.) −MISC1− AMENDMENTS 1999 − Subsec. (a)(1). Pub. L. 106−129 substituted "Director of the Agency for Healthcare Research and Quality" for "Administrator for Health Care Policy and Research". 1993 − Subsec. (a)(1). Pub. L. 103−43, Sec. 1811(4)(A), inserted
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", acting through the Director of the National Institutes of Health and after consultation with the Administrator for Health Care Policy and Research," after "The Secretary" and ", including treatment and prevention of HIV infection and related conditions among women" after "syndrome". Subsec. (b)(3). Pub. L. 103−43, Sec. 2008(d)(5), substituted "AIDS Research Advisory Committee" for "Clinical Research Review Committee". Subsec. (e). Pub. L. 103−43, Sec. 1811(4)(B), inserted before period at end ", and such sums as may be necessary for each of the fiscal years 1994 through 1996". TERMINATION OF REPORTING REQUIREMENTS For termination, effective May 15, 2000, of provisions in subsec. (d)(2) of this section relating to annual submission to Congress of reports describing projects carried out pursuant to subsec. (a) of this section, see section 3003 of Pub. L. 104−66, as amended, set out as a note under section 1113 of Title 31, Money and Finance, and page 94 of House Document No. 103−7. −End− −CITE− 42 USC Sec. 300cc−19 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME
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Part B − Research Authority −HEAD− Sec. 300cc−19. National blood resource education program −STATUTE− After consultation with the Director of the National Heart, Lung, and Blood Institute and the Commissioner of Food and Drugs, the Secretary shall establish a program of research and education regarding blood donations and transfusions to maintain and improve the safety of the blood supply. Education programs shall be directed at health professionals, patients, and the community to − (1) in the case of the public and patients undergoing treatment − (A) increase awareness that the process of donating blood is safe; (B) promote the concept that blood donors are contributors to a national need to maintain an adequate and safe blood supply; (C) encourage blood donors to donate more than once a year; and (D) encourage repeat blood donors to recruit new donors; (2) in the case of health professionals − (A) improve knowledge, attitudes, and skills of health professionals in the appropriate use of blood and blood components; (B) increase the awareness and understanding of health professionals regarding the risks versus benefits of blood transfusion; and
30
(C) encourage health professionals to consider alternatives to the administration of blood or blood components for their patients; and (3) in the case of the community, increase coordination, communication, and collaboration among community, professional, industry, and government organizations regarding blood donation and transfusion issues. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2319, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3074.) −End− −CITE− 42 USC Sec. 300cc−20 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− Sec. 300cc−20. Additional authority with respect to research −STATUTE− (a) Data collection with respect to national prevalence (1) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may, through representative sampling and other appropriate methodologies, provide for the
31
continuous collection of data on the incidence in the United States of cases of acquired immune deficiency syndrome and of cases of infection with the etiologic agent for such syndrome. The Secretary may carry out the program of data collection directly or through cooperative agreements and contracts with public and nonprofit private entities. (2) The Secretary shall encourage each State to enter into a cooperative agreement or contract under paragraph (1) with the Secretary in order to facilitate the prompt collection of the most recent accurate data on the incidence of cases described in such paragraph. (3) The Secretary shall ensure that data collected under paragraph (1) includes data on the demographic characteristics of the population of individuals with cases described in paragraph (1), including data on specific subpopulations at risk of infection with the etiologic agent for acquired immune deficiency syndrome. (4) In carrying out this subsection, the Secretary shall, for the purpose of assuring the utility of data collected under this section, request entities with expertise in the methodologies of data collection to provide, as soon as is practicable, assistance to the Secretary and to the States with respect to the development and utilization of uniform methodologies of data collection. (5) The Secretary shall provide for the dissemination of data collected pursuant to this subsection. In carrying out this paragraph, the Secretary may publish such data as frequently as the Secretary determines to be appropriate with respect to the
32
protection of the public health. The Secretary shall publish such data not less than once each year. (b) Epidemiological and demographic data (1) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop an epidemiological data base and shall provide for long−term studies for the purposes of − (A) collecting information on the demographic characteristics of the population of individuals infected with the etiologic agent for acquired immune deficiency syndrome and the natural history of such infection; and (B) developing models demonstrating the long−term domestic and international patterns of the transmission of such etiologic agent. (2) The Secretary may carry out paragraph (1) directly or through grants to, or cooperative agreeements (!1) or contracts with, public and nonprofit private entities, including Federal agencies. (c) Long−term research The Secretary may make grants to public and nonprofit private entities for the purpose of assisting grantees in conducting long−term research into treatments for acquired immune deficiency syndrome developed from knowledge of the genetic nature of the etiologic agent for such syndrome. (d) Social sciences research The Secretary, acting through the Director of the National Institute of Mental Health, may make grants to public and nonprofit
33
private entities for the purpose of assisting grantees in conducting scientific research into the psychological and social sciences as such sciences relate to acquired immune deficiency syndrome. (e) Authorization of appropriations (1) For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each fiscal year. (2) Amounts appropriated pursuant to paragraph (1) to carry out subsection (c) of this section shall remain available until expended. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2320, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3074; amended Pub. L. 100−690, title II, Sec. 2617(d), Nov. 18, 1988, 102 Stat. 4240; Pub. L. 102−531, title III, Sec. 312(d)(20), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103−43, title XVIII, Sec. 1811(5), (6), June 10, 1993, 107 Stat. 200.) −MISC1− AMENDMENTS 1993 − Subsec. (b)(1)(A). Pub. L. 103−43, Sec. 1811(5), inserted "and the natural history of such infection" after "syndrome". Subsec. (e)(1). Pub. L. 103−43, Sec. 1811(6), substituted "fiscal year" for "of the fiscal years 1989 through 1991". 1992 − Subsecs. (a)(1), (b)(1). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for
34
Disease Control". 1988 − Subsec. (a)(5). Pub. L. 100−690 substituted "subsection" for "section". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −FOOTNOTE− (!1) So in original. −End− −CITE− 42 USC Part C − Research Training 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part C − Research Training −HEAD− PART C − RESEARCH TRAINING −End− −CITE− 42 USC Sec. 300cc−31 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE
35
CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part C − Research Training −HEAD− Sec. 300cc−31. Fellowships and training −STATUTE− (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by the Centers for Disease Control and Prevention to train individuals to develop skills in epidemiology, surveillance, testing, counseling, education, information, and laboratory analysis relating to acquired immune deficiency syndrome. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after receiving such training, in national and international efforts toward the prevention, diagnosis, and treatment of acquired immune deficiency syndrome. (b) Programs conducted by National Institute of Mental Health The Secretary, acting through the Director of the National Institute of Mental Health, shall conduct or support fellowship and training programs for individuals pursuing graduate or postgraduate study in order to train such individuals to conduct scientific research into the psychological and social sciences as such sciences relate to acquired immune deficiency syndrome.
36
(c) Relationship to limitation on number of employees Any individual receiving a fellowship or receiving training under subsection (a) or (b) of this section shall not be included in any determination of the number of full−time equivalent employees of the Department of Health and Human Services for the purpose of any limitation on the number of such employees established by law prior to, on, or after November 4, 1988. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each fiscal year. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2341, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3076; amended Pub. L. 100−690, title II, Sec. 2617(e), Nov. 18, 1988, 102 Stat. 4240; Pub. L. 102−531, title III, Sec. 312(d)(21), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103−43, title XVIII, Sec. 1811(7), June 10, 1993, 107 Stat. 200.) −MISC1− AMENDMENTS 1993 − Subsec. (d). Pub. L. 103−43 substituted "fiscal year" for "of the fiscal years 1989 through 1991". 1992 − Subsec. (a). Pub. L. 102−531, which directed the substitution of "Centers for Disease Control and Prevention" for "Centers for Disease Control", was executed by making the substitution in two places to reflect the probable intent of
37
Congress. 1988 − Subsec. (c). Pub. L. 100−690 substituted "date of the enactment of the AIDS Amendments of 1988" for "date of the enactment of the AIDS Federal Policy Act of 1988" which for purposes of codification was translated as "November 4, 1988". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −End− −CITE− 42 USC Part D − Office of AIDS Research 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research −HEAD− PART D − OFFICE OF AIDS RESEARCH −End− −CITE− 42 USC subpart i − interagency coordination of activities 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE
38
CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart i − interagency coordination of activities −HEAD− SUBPART I − INTERAGENCY COORDINATION OF ACTIVITIES −MISC1− AMENDMENTS 1993 − Pub. L. 103−43, title XVIII, Sec. 1801(a)(1), (3), June 10, 1993, 107 Stat. 192, added part D designation and heading and subpart I heading and struck out former part D designation and heading "Special Authorities of the Director of the National Institutes of Health". −End− −CITE− 42 USC Sec. 300cc−40 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart i − interagency coordination of activities −HEAD− Sec. 300cc−40. Establishment of Office
39
−STATUTE− (a) In general There is established within the National Institutes of Health an office to be known as the Office of AIDS Research. The Office shall be headed by a director, who shall be appointed by the Secretary. (b) Duties (1) Interagency coordination of AIDS activities With respect to acquired immune deficiency syndrome, the Director of the Office shall plan, coordinate, and evaluate research and other activities conducted or supported by the agencies of the National Institutes of Health. In carrying out the preceding sentence, the Director of the Office shall evaluate the AIDS activities of each of such agencies and shall provide for the periodic reevaluation of such activities. (2) Consultations The Director of the Office shall carry out this subpart (including developing and revising the plan required in section 300cc−40b of this title) in consultation with the heads of the agencies of the National Institutes of Health, with the advisory councils of the agencies, and with the advisory council established under section 300cc−40a of this title. (3) Coordination The Director of the Office shall act as the primary Federal official with responsibility for overseeing all AIDS research conducted or supported by the National Institutes of Health, and (A) shall serve to represent the National Institutes of
40
Health AIDS Research Program at all relevant Executive branch task forces and committees; and (B) shall maintain communications with all relevant Public Health Service agencies and with various other departments of the Federal Government, to ensure the timely transmission of information concerning advances in AIDS research and the clinical treatment of acquired immune deficiency syndrome and its related conditions, between these various agencies for dissemination to affected communities and health care providers. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2351, as added Pub. L. 103−43, title XVIII, Sec. 1801(a)(3), June 10, 1993, 107 Stat. 192.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300cc−40b of this title. −End− −CITE− 42 USC Sec. 300cc−40a 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research
41
subpart i − interagency coordination of activities −HEAD− Sec. 300cc−40a. Advisory Council; coordinating committees −STATUTE− (a) Advisory Council (1) In general The Secretary shall establish an advisory council for the purpose of providing advice to the Director of the Office on carrying out this part. (Such council is referred to in this subsection as the "Advisory Council".) (2) Composition, compensation, terms, chair, etc. Subsections (b) through (g) of section 284a of this title apply to the Advisory Council to the same extent and in the same manner as such subsections apply to advisory councils for the national research institutes, except that − (A) in addition to the ex officio members specified in section 284a(b)(2) of this title, there shall serve as such members of the Advisory Council a representative from the advisory council of each of the National Cancer Institute and the National Institute on Allergy and Infectious Diseases; and (B) with respect to the other national research institutes, there shall serve as ex officio members of such Council, in addition to such members specified in subparagraph (A), a representative from the advisory council of each of the 2 institutes that receive the greatest funding for AIDS activities.
42
(b) Individual coordinating committees regarding research disciplines (1) In general The Director of the Office shall establish, for each research discipline in which any activity under the plan required in section 300cc−40b of this title is carried out, a committee for the purpose of providing advice to the Director of the Office on carrying out this part with respect to such discipline. (Each such committee is referred to in this subsection as a "coordinating committee".) (2) Composition Each coordinating committee shall be composed of representatives of the agencies of the National Institutes of Health with significant responsibilities regarding the research discipline involved. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2352, as added Pub. L. 103−43, title XVIII, Sec. 1801(a)(3), June 10, 1993, 107 Stat. 193.) −MISC1− TERMINATION OF ADVISORY COUNCILS Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2−year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to
43
the expiration of such 2−year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92−463, Oct. 6, 1972, 86 Stat. 770, 776, set out in the Appendix to Title 5, Government Organization and Employees. Pub. L. 93−641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300cc−40, 300cc−40b, 300cc−43 of this title. −End− −CITE− 42 USC Sec. 300cc−40b 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart i − interagency coordination of activities −HEAD− Sec. 300cc−40b. Comprehensive plan for expenditure of
44
appropriations −STATUTE− (a) In general Subject to the provisions of this section and other applicable law, the Director of the Office, in carrying out section 300cc−40 of this title, shall − (1) establish a comprehensive plan for the conduct and support of all AIDS activities of the agencies of the National Institutes of Health (which plan shall be first established under this paragraph not later than 12 months after June 10, 1993); (2) ensure that the Plan establishes priorities among the AIDS activities that such agencies are authorized to carry out; (3) ensure that the Plan establishes objectives regarding such activities, describes the means for achieving the objectives, and designates the date by which the objectives are expected to be achieved; (4) ensure that all amounts appropriated for such activities are expended in accordance with the Plan; (5) review the Plan not less than annually, and revise the Plan as appropriate; and (6) ensure that the Plan serves as a broad, binding statement of policies regarding AIDS activities of the agencies, but does not remove the responsibility of the heads of the agencies for the approval of specific programs or projects, or for other details of the daily administration of such activities, in accordance with the Plan.
45
(b) Certain components of Plan With respect to AIDS activities of the agencies of the National Institutes of Health, the Director of the Office shall ensure that the Plan − (1) provides for basic research; (2) provides for applied research; (3) provides for research that is conducted by the agencies; (4) provides for research that is supported by the agencies; (5) provides for proposals developed pursuant to solicitations by the agencies and for proposals developed independently of such solicitations; and (6) provides for behavioral research and social sciences research. (c) Budget estimates (1) Full−funding budget (A) With respect to a fiscal year, the Director of the Office shall prepare and submit directly to the President, for review and transmittal to the Congress, a budget estimate for carrying out the Plan for the fiscal year, after reasonable opportunity for comment (but without change) by the Secretary, the Director of the National Institutes of Health, and the advisory council established under section 300cc−40a of this title. The budget estimate shall include an estimate of the number and type of personnel needs for the Office. (B) The budget estimate submitted under subparagraph (A) shall estimate the amounts necessary for the agencies of the National
46
Institutes of Health to carry out all AIDS activities determined by the Director of the Office to be appropriate, without regard to the probability that such amounts will be appropriated. (2) Alternative budgets (A) With respect to a fiscal year, the Director of the Office shall prepare and submit to the Secretary and the Director of the National Institutes of Health the budget estimates described in subparagraph (B) for carrying out the Plan for the fiscal year. The Secretary and such Director shall consider each of such estimates in making recommendations to the President regarding a budget for the Plan for such year. (B) With respect to the fiscal year involved, the budget estimates referred to in subparagraph (A) for the Plan are as follows: (i) The budget estimate submitted under paragraph (1). (ii) A budget estimate developed on the assumption that the amounts appropriated will be sufficient only for − (I) continuing the conduct by the agencies of the National Institutes of Health of existing AIDS activities (if approved for continuation), and continuing the support of such activities by the agencies in the case of projects or programs for which the agencies have made a commitment of continued support; and (II) carrying out, of activities that are in addition to activities specified in subclause (I), only such activities for which the Director determines there is the most
47
substantial need. (iii) Such other budget estimates as the Director of the Office determines to be appropriate. (d) Funding (1) Authorization of appropriations For the purpose of carrying out AIDS activities under the Plan, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996. (2) Receipt of funds For the first fiscal year beginning after the date on which the Plan first established under subsection (a)(1) of this section has been in effect for 12 months, and for each subsequent fiscal year, the Director of the Office shall receive directly from the President and the Director of the Office of Management and Budget all funds available for AIDS activities of the National Institutes of Health. (3) Allocations for agencies (A) Each fiscal year the Director of the Office shall, from the amounts received under paragraph (2) for the fiscal year, allocate to the agencies of the National Institutes of Health (in accordance with the Plan) all amounts available for such year for carrying out the AIDS activities specified in subsection (c)(2)(B)(ii)(I) of this section for such year. Such allocation shall, to the extent practicable, be made not later than 15 days after the date on which the Director receives amounts under paragraph (2).
48
(B) Each fiscal year the Director of the Office shall, from the amounts received under paragraph (2) for the fiscal year, allocate to the agencies of the National Institutes of Health (in accordance with the Plan) all amounts available for such year for carrying out AIDS activities that are not referred to in subparagraph (A). Such allocation shall, to the extent practicable, be made not later than 30 days after the date on which the Director receives amounts under paragraph (2). −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2353, as added Pub. L. 103−43, title XVIII, Sec. 1801(a)(3), June 10, 1993, 107 Stat. 194.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 284, 300cc−40, 300cc−40a, 300cc−45 of this title. −End− −CITE− 42 USC Sec. 300cc−41 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart i − interagency coordination of activities
49
−HEAD− Sec. 300cc−41. Additional authorities −STATUTE− (a) In general In carrying out AIDS research, the Director of the Office − (1) shall develop and expand clinical trials of treatments and therapies for infection with the etiologic agent for acquired immune deficiency syndrome, including such clinical trials for women, infants, children, hemophiliacs, and minorities; (2) may establish or support the large−scale development and preclinical screening, production, or distribution of specialized biological materials and other therapeutic substances for AIDS research and set standards of safety and care for persons using such materials; (3) may support − (A) AIDS research conducted outside the United States by qualified foreign professionals if such research can reasonably be expected to benefit the people of the United States; (B) collaborative research involving American and foreign participants; and (C) the training of American scientists abroad and foreign scientists in the United States; (4) may encourage and coordinate AIDS research conducted by any industrial concern that evidences a particular capability for the conduct of such research; (5)(A) may acquire, improve, repair, operate, and maintain
50
laboratories, other research facilities, equipment, and such other real or personal property as the Director of the Office determines necessary; (B) may make grants for the construction or renovation of facilities; and (C) may acquire, without regard to section 8141 of title 40 by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the National Institutes of Health for a period not to exceed ten years; and (6) subject to section 284(b)(2) of this title and without regard to section 3324 of title 31 and section 5 of title 41, may enter into such contracts and cooperative agreements with any public agency, or with any person, firm, association, corporation, or educational institution, as may be necessary to expedite and coordinate research relating to acquired immune deficiency syndrome. (b) Report to Secretary The Director of the Office shall each fiscal year prepare and submit to the Secretary, for inclusion in the comprehensive report required in section 300cc(a) of this title, a report − (1) describing and evaluating the progress made in such fiscal year in research, treatment, and training with respect to acquired immune deficiency syndrome conducted or supported by the Institutes;
51
(2) summarizing and analyzing expenditures made in such fiscal year for activities with respect to acquired immune deficiency syndrome conducted or supported by the National Institutes of Health; and (3) containing such recommendations as the Director considers appropriate. (c) Projects for cooperation among public and private health entities In carrying out subsection (a) of this section, the Director of the Office shall establish projects to promote cooperation among Federal agencies, State, local, and regional public health agencies, and private entities, in research concerning the diagnosis, prevention, and treatment of acquired immune deficiency syndrome. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2354, formerly Sec. 2351, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3076; renumbered Sec. 2354 and amended Pub. L. 103−43, title XVIII, Sec. 1801(a)(2), (b), June 10, 1993, 107 Stat. 192, 196.) −COD− CODIFICATION In subsec. (a)(5)(C), "section 8141 of title 40" substituted for "the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L. 107−217, Sec. 5(c), Aug. 21, 2002, 116 Stat. 1303, the first section of which enacted Title 40, Public Buildings, Property, and Works.
52
−MISC1− AMENDMENTS 1993 − Pub. L. 103−43, Sec. 1801(b)(1), substituted "Additional" for "Establishment of" in section catchline. Subsec. (a). Pub. L. 103−43, Sec. 1801(b)(2)(A), in introductory provisions substituted "AIDS research, the Director of the Office" for "research with respect to acquired immune deficiency syndrome, the Secretary, acting through the Director of the National Institutes of Health". Subsec. (a)(1). Pub. L. 103−43, Sec. 1801(b)(2)(B), redesignated par. (3) as (1) and struck out former par. (1) which read as follows: "(A) shall establish an office to be known as the Office of AIDS Research, which Office shall be headed by a Director appointed by the Director of the National Institutes of Health; and "(B) shall provide administrative support and support services to the Director of such Office;". Subsec. (a)(2). Pub. L. 103−43, Sec. 1801(b)(2)(B), (E), redesignated par. (4) as (2), substituted "AIDS research" for "research relating to acquired immune deficiency syndrome", and struck out former par. (2) which read as follows: "shall coordinate activities relating to acquired immune deficiency syndrome conducted by the national research institutes and the agencies of the National Institutes of Health;". Subsec. (a)(3). Pub. L. 103−43, Sec. 1801(b)(2)(B), (C), (E), redesignated par. (5) as (3), struck out ", in consultation with
53
the advisory council for the appropriate national research institute of the National Institutes of Health," after "may" in introductory provisions, and substituted "AIDS research" for "research relating to acquired immune deficiency syndrome" in subpar. (A). Former par. (3) redesignated (1). Subsec. (a)(4). Pub. L. 103−43, Sec. 1801(b)(2)(B), (E), redesignated par. (6) as (4) and substituted "AIDS research" for "research relating to acquired immune deficiency syndrome". Former par. (4) redesignated (2). Subsec. (a)(5). Pub. L. 103−43, Sec. 1801(b)(2)(B), (D), redesignated par. (7) as (5), in subpar. (A) struck out ", in consultation with such advisory council," after "may" and substituted "Director of the Office determines" for "Director of the National Institutes of Health determines", and in subpars. (B) and (C) struck out ", in consultation with such advisory council," after "may". Former par. (5) redesignated (3). Subsec. (a)(6) to (8). Pub. L. 103−43, Sec. 1801(b)(2)(B), redesignated pars. (6) to (8) as (4) to (6), respectively. Subsec. (b). Pub. L. 103−43, Sec. 1801(b)(3), substituted "The Director of the Office shall" for "The Director of the National Institutes of Health, acting through the Director of the Office of AIDS Research, shall". Subsec. (c). Pub. L. 103−43, Sec. 1801(b)(4), substituted "the Director of the Office shall" for "the Director of the National Institutes of Health shall". −End−
54
−CITE− 42 USC subpart ii − emergency discretionary fund 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart ii − emergency discretionary fund −HEAD− SUBPART II − EMERGENCY DISCRETIONARY FUND −End− −CITE− 42 USC Sec. 300cc−43 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart ii − emergency discretionary fund −HEAD− Sec. 300cc−43. Emergency Discretionary Fund −STATUTE− (a) In general (1) Establishment
55
There is established a fund consisting of such amounts as may be appropriated under subsection (g) of this section. Subject to the provisions of this section, the Director of the Office, after consultation with the advisory council established under section 300cc−40a of this title, may expend amounts in the Fund for the purpose of conducting and supporting such AIDS activities, including projects of AIDS research, as may be authorized in this chapter for the National Institutes of Health. (2) Preconditions to use of Fund Amounts in the Fund may be expended only if − (A) the Director identifies the particular set of AIDS activities for which such amounts are to be expended; (B) the set of activities so identified constitutes either a new project or additional AIDS activities for an existing project; (C) the Director of the Office has made a determination that there is a significant need for such set of activities; and (D) as of June 30 of the fiscal year preceding the fiscal year in which the determination is made, such need was not provided for in any appropriations Act passed by the House of Representatives to make appropriations for the Departments of Labor, Health and Human Services (including the National Institutes of Health), Education, and related agencies for the fiscal year in which the determination is made. (3) Two−year use of Fund for project involved In the case of an identified set of AIDS activities,
56
obligations of amounts in the Fund may not be made for such set of activities after the expiration of the 2−year period beginning on the date on which the initial obligation of such amounts is made for such set. (b) Peer review With respect to an identified set of AIDS activities carried out with amounts in the Fund, this section may not be construed as waiving applicable requirements for peer review. (c) Limitations on use of Fund (1) Construction of facilities Amounts in the Fund may not be used for the construction, renovation, or relocation of facilities, or for the acquisition of land. (2) Congressional disapproval of projects (A) Amounts in the Fund may not be expended for the fiscal year involved for an identified set of AIDS activities, or a category of AIDS activities, for which − (i)(I) amounts were made available in an appropriations Act for the preceding fiscal year; and (II) amounts are not made available in any appropriations Act for the fiscal year involved; or (ii) amounts are by law prohibited from being expended. (B) A determination under subparagraph (A)(i) of whether amounts have been made available in appropriations Acts for a fiscal year shall be made without regard to whether such Acts make available amounts for the Fund.
57
(3) Investment of Fund amounts Amounts in the Fund may not be invested. (d) Applicability of limitation regarding number of employees The purposes for which amounts in the Fund may be expended include the employment of individuals necessary to carry out identified sets of AIDS activities approved under subsection (a) of this section. Any individual employed under the preceding sentence may not be included in any determination of the number of full−time equivalent employees for the Department of Health and Human Services for the purpose of any limitation on the number of such employees established by law prior to, on, or after June 10, 1993. (e) Report to Congress Not later than February 1 of each fiscal year, the Director of the Office shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report on the identified sets of AIDS activities carried out during the preceding fiscal year with amounts in the Fund. The report shall provide a description of each such set of activities and an explanation of the reasons underlying the use of the Fund for the set. (f) Definitions For purposes of this section: (1) The term "Fund" means the fund established in subsection (a) of this section. (2) The term "identified set of AIDS activities" means a particular set of AIDS activities identified under subsection
58
(a)(2)(A) of this section. (g) Funding (1) Authorization of appropriations For the purpose of providing amounts for the Fund, there is authorized to be appropriated $100,000,000 for each of the fiscal years 1994 through 1996. (2) Availability Amounts appropriated for the Fund are available until expended. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2356, as added Pub. L. 103−43, title XVIII, Sec. 1802, June 10, 1993, 107 Stat. 196.) −CHANGE− CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −End− −CITE− 42 USC subpart iii − general provisions 01/06/03
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−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart iii − general provisions −HEAD− SUBPART III − GENERAL PROVISIONS −End− −CITE− 42 USC Sec. 300cc−45 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part D − Office of AIDS Research subpart iii − general provisions −HEAD− Sec. 300cc−45. General provisions regarding Office −STATUTE− (a) Administrative support for Office The Secretary, acting through the Director of the National Institutes of Health, shall provide administrative support and support services to the Director of the Office and shall ensure
60
that such support takes maximum advantage of existing administrative structures at the agencies of the National Institutes of Health. (b) Evaluation and report (1) Evaluation Not later than 5 years after June 10, 1993, the Secretary shall conduct an evaluation to − (A) determine the effect of this section on the planning and coordination of the AIDS research programs at the institutes, centers and divisions of the National Institutes of Health; (B) evaluate the extent to which this part has eliminated the duplication of administrative resources among such Institutes, centers and divisions; and (C) provide recommendations concerning future alterations with respect to this part. (2) Report Not later than 1 year after the date on which the evaluation is commenced under paragraph (1), the Secretary shall prepare and submit to the Committee on Labor and Human Resources of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a report concerning the results of such evaluation. (c) Definitions For purposes of this part: (1) The term "AIDS activities" means AIDS research and other activities that relate to acquired immune deficiency syndrome.
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(2) The term "AIDS research" means research with respect to acquired immune deficiency syndrome. (3) The term "Office" means the Office of AIDS Research. (4) The term "Plan" means the plan required in section 300cc−40b(a)(1) of this title. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2359, as added Pub. L. 103−43, title XVIII, Sec. 1803, June 10, 1993, 107 Stat. 198.) −CHANGE− CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −End− −CITE− 42 USC Part E − General Provisions 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE
62
SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part E − General Provisions −HEAD− PART E − GENERAL PROVISIONS −End− −CITE− 42 USC Sec. 300cc−51 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part E − General Provisions −HEAD− Sec. 300cc−51. Definitions −STATUTE− For purposes of this subchapter: (1) The term "infection", with respect to the etiologic agent for acquired immune deficiency syndrome, includes opportunistic cancers and infectious diseases and any other conditions arising from infection with such etiologic agent. (2) The term "treatment", with respect to the etiologic agent for acquired immune deficiency syndrome, includes primary and secondary prophylaxis. −SOURCE−
63
(July 1, 1944, ch. 373, title XXIII, Sec. 2361, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3078; amended Pub. L. 103−43, title XVIII, Sec. 1811(8), June 10, 1993, 107 Stat. 200.) −MISC1− AMENDMENTS 1993 − Pub. L. 103−43 substituted provisions defining "infection" and "treatment" for former provisions which read as follows: "For purposes of this subchapter, the term 'infection with the etiologic agent for acquired immune deficiency syndrome' includes any condition arising from infection with such etiologic agent". −End− −CITE− 42 USC SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME −End− −CITE− 42 USC Part A − Formula Grants to States for Home and
64
Community−Based Health Services 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States for Home and Community−Based Health Services −HEAD− PART A − FORMULA GRANTS TO STATES FOR HOME AND COMMUNITY−BASED HEALTH SERVICES −End− −CITE− 42 USC Secs. 300dd to 300dd−14 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States for Home and Community−Based Health Services −HEAD− Secs. 300dd to 300dd−14. Repealed. July 1, 1944, ch. 373, title XXIV, Sec. 2415, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3088; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2618(g), 102 Stat. 4241
65
−MISC1− Section 300dd, act July 1, 1944, ch. 373, title XXIV, Sec. 2401, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3079, established program of formula grants for home and community−based health services. Section 300dd−1, act July 1, 1944, ch. 373, title XXIV, Sec. 2402, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3080; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2618(a), 102 Stat. 4240, provided requirements for carrying out purpose of grants. Section 300dd−2, act July 1, 1944, ch. 373, title XXIV, Sec. 2403, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3081, required submission of description of intended uses of grant. Section 300dd−3, act July 1, 1944, ch. 373, title XXIV, Sec. 2404, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3081; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2618(b), 102 Stat. 4240, restricted use of grants. Section 300dd−4, act July 1, 1944, ch. 373, title XXIV, Sec. 2405, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3082, required reports and audits by States. Section 300dd−5, act July 1, 1944, ch. 373, title XXIV, Sec. 2406, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3083, required additional agreements. Section 300dd−6, act July 1, 1944, ch. 373, title XXIV, Sec. 2407, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211,
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102 Stat. 3084, required submission of application containing certain agreements and assurances. Section 300dd−7, act July 1, 1944, ch. 373, title XXIV, Sec. 2408, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3084, provided for determination of amount of allotments for States. Section 300dd−8, act July 1, 1944, ch. 373, title XXIV, Sec. 2409, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3085; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2618(c), 102 Stat. 4241, related to failure to comply with agreements. Section 300dd−9, act July 1, 1944, ch. 373, title XXIV, Sec. 2410, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3087, prohibited certain false statements. Section 300dd−10, act July 1, 1944, ch. 373, title XXIV, Sec. 2411, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3087; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2618(d), 102 Stat. 4241, authorized the Secretary to provide technical assistance and supplies and services in lieu of grant funds. Section 300dd−11, act July 1, 1944, ch. 373, title XXIV, Sec. 2412, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3087, required report by Secretary. Section 300dd−12, act July 1, 1944, ch. 373, title XXIV, Sec. 2413, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3087; amended Nov. 18, 1988, Pub. L. 100−690, title II,
67
Sec. 2618(e), 102 Stat. 4241, defined terms for this part. Section 300dd−13, act July 1, 1944, ch. 373, title XXIV, Sec. 2414, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3088; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2618(f), 102 Stat. 4241, provided funding. Section 300dd−14, act July 1, 1944, ch. 373, title XXIV, Sec. 2415, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3088; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2618(g), 102 Stat. 4241, repealed this part effective with respect to appropriations made for any period after fiscal year 1990. EFFECTIVE DATE OF REPEAL Repeal effective with respect to appropriations made for any period after fiscal year 1990, see section 2415 of act July 1, 1944, which was classified to former section 300dd−14 of this title. −End− −CITE− 42 USC Part B − Subacute Care 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Subacute Care −HEAD−
68
PART B − SUBACUTE CARE −End− −CITE− 42 USC Sec. 300dd−21 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Subacute Care −HEAD− Sec. 300dd−21. Demonstration projects −STATUTE− (a) Definitions As used in this section: (1) The term "individuals infected with the etiologic agent for acquired immune deficiency syndrome" means individuals who have a disease, or are recovering from a disease, attributable to the infection of such individuals with such etiologic agent, and as a result of the effects of such disease, are in need of subacute−care services. (2) The term "subacute care" means medical and health care services that are required for individuals recovering from acute care episodes that are less intensive than the level of care provided in acute−care hospitals, and includes skilled nursing care, hospice care, and other types of health services provided
69
in other long−term−care facilities. (b) Authorization to conduct three projects The Secretary shall conduct three demonstration projects to determine the effectiveness and cost of providing the subacute−care services described in subsection (b) of this section to individuals infected with the etiologic agent for acquired immune deficiency syndrome, and the impact of such services on the health status of such individuals. (c) Services (1) The services provided under each demonstration project shall be designed to meet the specific needs of individuals infected with the etiologic agent for acquired immune deficiency syndrome, and shall include − (A) the care and treatment of such individuals by providing − (i) subacute care; (ii) emergency medical care and specialized diagnostic and therapeutic services as needed and where appropriate, either directly or through affiliation with a hospital that has experience in treating individuals with acquired immune deficiency syndrome; and (iii) case management services to ensure, through existing services and programs whenever possible, appropriate discharge planning for such individuals; and (B) technical assistance, to other facilities in the region served by such facility, that is directed toward education and training of physicians, nurses, and other health−care
70
professionals in the subacute care and treatment of individuals infected with the etiologic agent for acquired immune deficiency syndrome. (2) Services provided under each demonstration project may also include − (A) hospice services; (B) outpatient care; and (C) outreach activities in the surrounding community to hospitals and other health−care facilities that serve individuals infected with the etiologic agent for acquired immune deficiency syndrome. (d) Time and place The demonstration projects shall be conducted − (1) during a 4−year period beginning not later than 9 months after November 4, 1988; and (2) at sites that − (A) are geographically diverse and located in areas that are appropriate for the provision of the required and authorized services; and (B) have the highest incidence of cases of acquired immune deficiency syndrome and the greatest need for subacute−care services. (e) Evaluation and report The Secretary shall evaluate the operations of the demonstration projects and shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and
71
Human Resources of the Senate − (1) not later than 18 months after the beginning of the first project, a preliminary report that contains − (A) a description of the sites at which the projects are being conducted and of the services being provided in each project; and (B) a preliminary evaluation of the experience of the projects in the first 12 months of operation; and (2) not later than 6 months after the completion of the last project, a final report that contains − (A) an assessment of the costs of subacute care for individuals infected with the etiologic agent for acquired immune deficiency syndrome, including a breakdown of all other sources of funding for the care provided to cover subacute care; and (B) recommendations for appropriate legislative changes. (f) Other research Each demonstration project shall provide for other research to be carried out at the site of such demonstration project including − (1) clinical research on acquired immune deficiency syndrome, concentrating on research on the neurological manifestations resulting from infection with the etiologic agent for such syndrome; and (2) the study of the psychological and mental health issues related to such syndrome. (g) Authorization of appropriations
72
(1) To carry out this section, there are authorized to be appropriated $10,000,000 for fiscal year 1989 and such sums as are necessary for each of the fiscal years 1990 through 1992. (2) Amounts appropriated pursuant to paragraph (1) shall remain available until September 10, 1992. (h) Services to veterans The Secretary shall enter into an agreement with the Secretary of the Department of Veterans Affairs to ensure that appropriate provision will be made for the furnishing, through demonstration projects, of services to eligible veterans, under contract with the Department of Veterans Affairs pursuant to section 1720 of title 38. −SOURCE− (July 1, 1944, ch. 373, title XXIV, Sec. 2421, as added Pub. L. 100−607, title II, Sec. 211, Nov. 4, 1988, 102 Stat. 3088; amended Pub. L. 100−527, Sec. 10(1), (2), Oct. 25, 1988, 102 Stat. 2640, 2641; Pub. L. 100−690, title II, Sec. 2618(h), Nov. 18, 1988, 102 Stat. 4241; Pub. L. 102−83, Sec. 5(c)(2), Aug. 6, 1991, 105 Stat. 406.) −MISC1− AMENDMENTS 1991 − Subsec. (h). Pub. L. 102−83 substituted "section 1720 of title 38" for "section 620 of title 38". 1988 − Subsec. (a)(1). Pub. L. 100−690, Sec. 2618(h)(1), substituted " 'individuals infected with the etiologic agent for acquired immune deficiency syndrome' means individuals who" for "
73
'patients infected with the human immunodeficiency virus' means persons who" and "such individuals with such etiologic agent" for "such person with the human immunodeficiency virus". Subsec. (a)(2). Pub. L. 100−690, Sec. 2618(h)(2), substituted "individuals" for "persons". Subsec. (b). Pub. L. 100−690, Sec. 2618(h)(3), substituted "individuals infected with the etiologic agent for acquired immune deficiency syndrome" for "patients infected with the human immunodeficiency virus" and "such individuals" for "such patients". Subsec. (c)(1). Pub. L. 100−690, Sec. 2618(h)(4)(A), in introductory provisions substituted "individuals infected with the etiologic agent for acquired immune deficiency syndrome" for "patients infected with the human immunodeficiency virus". Subsec. (c)(1)(A). Pub. L. 100−690, Sec. 2618(h)(4)(B), substituted in introductory provisions "such individuals" for "such patients", in cl. (ii) "individuals with acquired immune deficiency syndrome" for "AIDS patients", and in cl. (iii) "such individuals" for "patients". Subsec. (c)(1)(B), (2)(C). Pub. L. 100−690, Sec. 2618(h)(4)(C), (5), substituted "individuals infected with the etiologic agent for acquired immune deficiency syndrome" for "patients infected with the human immunodeficiency virus". Subsec. (d)(2)(B). Pub. L. 100−690, Sec. 2618(h)(6), substituted "cases of acquired immune deficiency syndrome" for "AIDS cases". Subsec. (e)(2)(A). Pub. L. 100−690, Sec. 2618(h)(7), substituted "individuals infected with the etiologic agent for acquired immune
74
deficiency syndrome" for "patients infected with the human immunodeficiency virus". Subsec. (f)(1). Pub. L. 100−690, Sec. 2618(h)(8), substituted "acquired immune deficiency syndrome" for "the acquired immunodeficiency syndrome" and "etiologic agent for such syndrome" for "human immunodeficiency virus". Subsec. (f)(2). Pub. L. 100−690, Sec. 2618(h)(9), substituted "such syndrome" for "the acquired immunodeficiency syndrome". Subsec. (g)(1). Pub. L. 100−690, Sec. 2618(h)(10), substituted "fiscal year 1989" for "fiscal year 1988" and "fiscal years 1990 through 1992" for "fiscal years 1989 through 1991". Subsec. (h). Pub. L. 100−527 substituted "Secretary of the Department of Veterans Affairs" and "Department of Veterans Affairs" for "Administrator of the Veterans' Administration" and "Veterans' Administration", respectively. −CHANGE− CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh
75
Congress, Jan. 3, 2001. −MISC2− EFFECTIVE DATE OF 1988 AMENDMENTS Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. Amendment by Pub. L. 100−527 effective Mar. 15, 1989, see section 18(a) of Pub. L. 100−527, set out as a Department of Veterans Affairs Act note under section 301 of Title 38, Veterans' Benefits. −End− −CITE− 42 USC Part C − Other Health Services 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part C − Other Health Services −HEAD− PART C − OTHER HEALTH SERVICES −COD− CODIFICATION Prior to revision by Pub. L. 102−321, this part was comprised of subpart I, consisting of sections 300dd−31 to 300dd−33, and subpart II, consisting of section 300dd−41.
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−End− −CITE− 42 USC Sec. 300dd−31 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part C − Other Health Services −HEAD− Sec. 300dd−31. Grants for anonymous testing −STATUTE− The Secretary may make grants to the States for the purpose of providing opportunities for individuals − (1) to undergo counseling and testing with respect to the etiologic agent for acquired immune deficiency syndrome without being required to provide any information relating to the identity of the individuals; and (2) to undergo such counseling and testing through the use of a pseudonym. −SOURCE− (July 1, 1944, ch. 373, title XXIV, Sec. 2431, as added Pub. L. 100−607, title II, Sec. 211, Nov. 4, 1988, 102 Stat. 3090.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300dd−32, 300dd−33 of
77
this title. −End− −CITE− 42 USC Sec. 300dd−32 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part C − Other Health Services −HEAD− Sec. 300dd−32. Requirement of provision of certain counseling services −STATUTE− (a) Counseling before testing The Secretary may not make a grant under section 300dd−31 of this title to a State unless the State agrees that, before testing an individual pursuant to such section, the State will provide to the individual appropriate counseling with respect to acquired immune deficiency syndrome (based on the most recent scientific data relating to such syndrome), including − (1) measures for the prevention of exposure to, and the transmission of, the etiologic agent for such syndrome; (2) the accuracy and reliability of the results of such testing; (3) the significance of the results of such testing, including
78
the potential for developing acquired immune deficiency syndrome; and (4) encouraging individuals, as appropriate, to undergo testing for such etiologic agent and providing information on the benefits of such testing. (b) Counseling of individuals with negative test results The Secretary may not make a grant under section 300dd−31 of this title to a State unless the State agrees that, if the results of testing conducted pursuant to such section indicate that an individual is not infected with the etiologic agent for acquired immune deficiency syndrome, the State will review for the individual the information provided pursuant to subsection (a) of this section with respect to such syndrome, including − (1) the information described in paragraphs (1) through (3) of such subsection; and (2) the appropriateness of further counseling, testing, and education of the individual with respect to acquired immune deficiency syndrome. (c) Counseling of individuals with positive test results The Secretary may not make a grant under section 300dd−31 of this title to a State unless the State agrees that, if the results of testing conducted pursuant to such section indicate that an individual is infected with the etiologic agent for acquired immune deficiency syndrome, the State will provide to the individual appropriate counseling with respect to such syndrome, including − (1) reviewing the information described in paragraphs (1)
79
through (3) of subsection (a) of this section; (2) reviewing the appropriateness of further counseling, testing, and education of the individual with respect to acquired immune deficiency syndrome; (3) the importance of not exposing others to the etiologic agent for acquired immune deficiency syndrome; (4) the availability in the geographic area of any appropriate services with respect to health care, including mental health care and social and support services; (5) the benefits of locating and counseling any individual by whom the infected individual may have been exposed to the etiologic agent for acquired immune deficiency syndrome and any individual whom the infected individual may have exposed to such etiologic agent; and (6) the availability, if any, of the services of public health authorities with respect to locating and counseling any individual described in paragraph (5). (d) Rule of construction with respect to counseling without testing Agreements entered into pursuant to subsections (a) through (c) of this section may not be construed to prohibit any grantee under section 300dd−31 of this title from expending the grant for the purpose of providing counseling services described in such subsections to an individual who will not undergo testing described in such section as a result of the grantee or the individual determining that such testing of the individual is not appropriate. (e) Use of funds
80
(1) The purpose of this subpart (!1) is to provide for counseling and testing services to prevent and reduce exposure to, and transmission of, the etiologic agent for acquired immune deficiency syndrome. (2) All individuals receiving counseling pursuant to this subpart (!1) are to be counseled about the harmful effects of promiscuous sexual activity and intravenous substance abuse, and the benefits of abstaining from such activities. (3) None of the fund appropriated to carry out this subpart (!1) may be used to provide counseling that is designed to promote or encourage, directly, homosexual or heterosexual sexual activity or intravenous drug abuse. (4) Paragraph (3) may not be construed to prohibit a counselor who has already performed the counseling of an individual required by paragraph (2), to provide accurate information about means to reduce an individual's risk of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any informational materials used are not obscene. −SOURCE− (July 1, 1944, ch. 373, title XXIV, Sec. 2432, as added Pub. L. 100−607, title II, Sec. 211, Nov. 4, 1988, 102 Stat. 3090; amended Pub. L. 100−690, title II, Sec. 2618(i), Nov. 18, 1988, 102 Stat. 4242; Pub. L. 102−321, title I, Sec. 118(b)(1)(B), July 10, 1992, 106 Stat. 348.) −MISC1− AMENDMENTS
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1992 − Subsec. (a). Pub. L. 102−321, which directed the substitution of "part" for "subpart" wherever appearing in subsec. (a), could not be executed because the word "subpart" does not appear in subsec. (a). 1988 − Subsec. (c). Pub. L. 100−690, Sec. 2618(i)(1), substituted "indicate that an individual" for "indicate that the individual" in introductory provisions and "paragraph (5)" for "paragraph (4)" in par. (6). Subsec. (e)(1) to (3). Pub. L. 100−690, Sec. 2618(i)(2), substituted "subpart" for "part". EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−321 effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of Pub. L. 102−321, set out as a note under section 236 of this title. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −FOOTNOTE− (!1) So in original. Probably should be "part". −End− −CITE− 42 USC Sec. 300dd−33 01/06/03 −EXPCITE−
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TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part C − Other Health Services −HEAD− Sec. 300dd−33. Funding −STATUTE− For the purpose of grants under section 300dd−31 of this title, there are authorized to be appropriated $100,000,000 for each of the fiscal years 1989 and 1990. −SOURCE− (July 1, 1944, ch. 373, title XXIV, Sec. 2433, as added Pub. L. 100−607, title II, Sec. 211, Nov. 4, 1988, 102 Stat. 3091.) −End− −CITE− 42 USC Sec. 300dd−41 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXII − HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part C − Other Health Services −HEAD− Sec. 300dd−41. Transferred −COD−
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CODIFICATION Section, act July 1, 1944, ch. 373, title XXIV, Sec. 2441, as added Nov. 4, 1988, Pub. L. 100−607, title II, Sec. 211, 102 Stat. 3092, which related to demonstration projects for individuals with positive AIDS test results, was renumbered section 520B of act July 1, 1944, by Pub. L. 102−321, title I, Sec. 118(a), July 10, 1992, 106 Stat. 348, and was transferred to section 290bb−33 of this title, prior to repeal by Pub. L. 106−310, div. B, title XXXII, Sec. 3201(b)(2), Oct. 17, 2000, 114 Stat. 1190. −End− −CITE− 42 USC SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −End− −CITE− 42 USC Sec. 300ee 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE
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SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− Sec. 300ee. Use of funds −STATUTE− (a) In general The purpose of this subchapter is to provide for the establishment of education and information programs to prevent and reduce exposure to, and the transmission of, the etiologic agent for acquired immune deficiency syndrome. (b) Contents of programs All programs of education and information receiving funds under this subchapter shall include information about the harmful effects of promiscuous sexual activity and intravenous substance abuse, and the benefits of abstaining from such activities. (c) Limitation None of the funds appropriated to carry out this subchapter may be used to provide education or information designed to promote or encourage, directly, homosexual or heterosexual sexual activity or intravenous substance abuse. (d) Construction Subsection (c) of this section may not be construed to restrict the ability of an education program that includes the information required in subsection (b) of this section to provide accurate information about various means to reduce an individual's risk of exposure to, or the transmission of, the etiologic agent for acquired immune deficiency syndrome, provided that any
85
informational materials used are not obscene. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2500, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3093; amended Pub. L. 100−690, title II, Sec. 2619(a), Nov. 18, 1988, 102 Stat. 4242; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− AMENDMENTS 1988 − Subsec. (a). Pub. L. 100−690 substituted "this subchapter" for "this part". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −End− −CITE− 42 USC Sec. 300ee−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− Sec. 300ee−1. Establishment of office with respect to minority health and acquired immune deficiency syndrome
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−STATUTE− The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall establish an office for the purpose of ensuring that, in carrying out the duties of the Secretary with respect to prevention of acquired immune deficiency syndrome, the Secretary develops and implements prevention programs targeted at minority populations and provides appropriate technical assistance in the implementation of such programs. −SOURCE− (Pub. L. 100−607, title II, Sec. 252, Nov. 4, 1988, 102 Stat. 3108; Pub. L. 102−531, title III, Sec. 312(e)(2), Oct. 27, 1992, 106 Stat. 3506.) −COD− CODIFICATION Section was enacted as part of the AIDS Amendments of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health Service Act which comprises this chapter. −MISC1− AMENDMENTS 1992 − Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". REQUIREMENT OF STUDY WITH RESPECT TO MINORITY HEALTH AND ACQUIRED IMMUNE DEFICIENCY SYNDROME Section 251 of Pub. L. 100−607, as amended by Pub. L. 100−690, title II, Sec. 2602(b), Nov. 18, 1988, 102 Stat. 4234, provided
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that: "(a) In General. − The Secretary of Health and Human Services, acting through the Director of the Office of Minority Health, shall conduct a study for the purpose of determining − "(1) the level of knowledge within minority communities concerning acquired immune deficiency syndrome, the risks of the transmission of the etiologic agent for such syndrome, and the means of reducing such risk; and "(2) the effectiveness of Federal, State, and local prevention programs with respect to acquired immune deficiency syndrome in minority communities. "(b) Report. − The Secretary shall, not later than 12 months after the date of the enactment of this title [Nov. 4, 1988], complete the study required in subsection (a) and submit to the Congress a report describing the findings made as a result of the study." −End− −CITE− 42 USC Sec. 300ee−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− Sec. 300ee−2. Information for health and public safety workers −STATUTE−
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(a) Development and dissemination of guidelines Not later than 90 days after November 4, 1988, the Secretary of Health and Human Services (hereafter in this section referred to as the "Secretary"), acting through the Director of the Centers for Disease Control and Prevention, shall develop, issue, and disseminate emergency guidelines to all health workers and public safety workers (including emergency response employees) in the United States concerning − (1) methods to reduce the risk in the workplace of becoming infected with the etiologic agent for acquired immune deficiency syndrome; and (2) circumstances under which exposure to such etiologic agent may occur. (b) Use in occupational standards The Secretary shall transmit the guidelines issued under subsection (a) of this section to the Secretary of Labor for use by the Secretary of Labor in the development of standards to be issued under the Occupational Safety and Health Act of 1970 [29 U.S.C. 651 et seq.]. (c) Development and dissemination of model curriculum for emergency response employees (1) Not later than 90 days after November 4, 1988, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall develop a model curriculum for emergency response employees with respect to the prevention of exposure to the etiologic agent for acquired immune deficiency syndrome during the
89
process of responding to emergencies. (2) In carrying out paragraph (1), the Secretary shall consider the guidelines issued by the Secretary under subsection (a) of this section. (3) The model curriculum developed under paragraph (1) shall, to the extent practicable, include − (A) information with respect to the manner in which the etiologic agent for acquired immune deficiency syndrome is transmitted; and (B) information that can assist emergency response employees in distinguishing between conditions in which such employees are at risk with respect to such etiologic agent and conditions in which such employees are not at risk with respect (!1) such etiologic agent. (4) The Secretary shall establish a task force to assist the Secretary in developing the model curriculum required in paragraph (1). The Secretary shall appoint to the task force representatives of the Centers for Disease Control and Prevention, representatives of State governments, and representatives of emergency response employees. (5) The Secretary shall − (A) transmit to State public health officers copies of the guidelines and the model curriculum developed under paragraph (1) with the request that such officers disseminate such copies as appropriate throughout the State; and (B) make such copies available to the public.
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−SOURCE− (Pub. L. 100−607, title II, Sec. 253, Nov. 4, 1988, 102 Stat. 3108; Pub. L. 100−690, title II, Sec. 2602(c), Nov. 18, 1988, 102 Stat. 4234; Pub. L. 102−531, title III, Sec. 312(e)(3), Oct. 27, 1992, 106 Stat. 3506.) −REFTEXT− REFERENCES IN TEXT The Occupational Safety and Health Act of 1970, referred to in subsec. (b), is Pub. L. 91−596, Dec. 29, 1970, 84 Stat. 1590, as amended, which is classified principally to chapter 15 (Sec. 651 et seq.) of Title 29, Labor. For complete classification of this Act to the Code, see Short Title note set out under section 651 of Title 29 and Tables. −COD− CODIFICATION Section was enacted as part of the AIDS Amendments of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health Service Act which comprises this chapter. −MISC1− AMENDMENTS 1992 − Subsecs. (a), (c)(1), (4). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". 1988 − Subsec. (a). Pub. L. 100−690 substituted "health workers and public safety workers" for "health workers, public safety workers".
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EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. GUIDELINES FOR PREVENTION OF TRANSMISSION OF HUMAN IMMUNODEFICIENCY AND HEPATITIS B VIRUSES DURING INVASIVE PROCEDURES Pub. L. 102−141, title VI, Sec. 633, Oct. 28, 1991, 105 Stat. 876, provided that: "Notwithstanding any other provision of law, each State Public Health Official shall, not later than one year after the date of enactment of this Act [Oct. 28, 1991], certify to the Secretary of Health and Human Services that guidelines issued by the Centers for Disease Control, or guidelines which are equivalent to those promulgated by the Centers for Disease Control concerning recommendations for preventing the transmission of the human immunodeficiency virus and the hepatitis B virus during exposure prone invasive procedures, except for emergency situations when the patient's life or limb is in danger, have been instituted in the State. State guidelines shall apply to health professionals practicing within the State and shall be consistent with Federal law. Compliance with such guidelines shall be the responsibility of the State Public Health Official. Said responsibilities shall include a process for determining what appropriate disciplinary or other actions shall be taken to ensure compliance. If such certification is not provided under this section within the one−year period, the State shall be ineligible to receive
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assistance under the Public Health Service Act (42 U.S.C. 301 [201] et seq.) until such certification is provided, except that the Secretary may extend the time period for a State, upon application of such State, that additional time is required for instituting said guidelines." [Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102−531, title III, Sec. 312, Oct. 27, 1992, 106 Stat. 3504.] −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ee−12, 300ff−80 of this title. −FOOTNOTE− (!1) So in original. Probably should be "respect to". −End− −CITE− 42 USC Sec. 300ee−3 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− Sec. 300ee−3. Continuing education for health care providers −STATUTE− (a) In general The Secretary of Health and Human Services (hereafter in this
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section referred to as the "Secretary") may make grants to nonprofit organizations composed of, or representing, health care providers to assist in the payment of the costs of projects to train such providers concerning − (1) appropriate infection control procedures to reduce the transmission of the etiologic agent for acquired immune deficiency syndrome; and (2) the provision of care and treatment to individuals with such syndrome or related illnesses. (b) Limitation The Secretary may make a grant under subsection (a) of this section to an entity only if the entity will provide services under the grant in a geographic area, or to a population of individuals, not served by a program substantially similar to the program described in subsection (a) of this section. (c) Requirement of matching funds (1) The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such subsection, to make available, directly or through donations from public or private entities, non−Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an amount equal to not less than $2 for each $1 of Federal funds provided in such payments. (2) Non−Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or
94
services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non−Federal contributions. (d) Requirement of application The Secretary may not make a grant under subsection (a) of this section unless − (1) an application for the grant is submitted to the Secretary; (2) with respect to carrying out the purpose for which the grant is to be made, the application provides assurances of compliance satisfactory to the Secretary; and (3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. (e) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991. −SOURCE− (Pub. L. 100−607, title II, Sec. 254, Nov. 4, 1988, 102 Stat. 3109.) −COD− CODIFICATION Section was enacted as part of the AIDS Amendments of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as
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part of the Public Health Service Act which comprises this chapter. −End− −CITE− 42 USC Sec. 300ee−4 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− Sec. 300ee−4. Technical assistance −STATUTE− The Secretary of Health and Human Services shall provide technical assistance to public and nonprofit private entities carrying out programs, projects, and activities relating to acquired immune deficiency syndrome. −SOURCE− (Pub. L. 100−607, title II, Sec. 255, Nov. 4, 1988, 102 Stat. 3110.) −COD− CODIFICATION Section was enacted as part of the AIDS Amendments of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health Service Act which comprises this chapter. −End− −CITE− 42 USC Sec. 300ee−5 01/06/03
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−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− Sec. 300ee−5. Use of funds to supply hypodermic needles or syringes for illegal drug use; prohibition −STATUTE− None of the funds provided under this Act or an amendment made by this Act shall be used to provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs, unless the Surgeon General of the Public Health Service determines that a demonstration needle exchange program would be effective in reducing drug abuse and the risk that the public will become infected with the etiologic agent for acquired immune deficiency syndrome. −SOURCE− (Pub. L. 100−607, title II, Sec. 256(b), Nov. 4, 1988, 102 Stat. 3110; Pub. L. 100−690, title II, Sec. 2602(d)(1), Nov. 18, 1988, 102 Stat. 4234.) −REFTEXT− REFERENCES IN TEXT This Act, referred to in text, is Pub. L. 100−607, Nov. 4, 1988, 102 Stat. 3048, as amended, known as the "Health Omnibus Programs Extension of 1988". For complete classification of this Act to the Code, see Short Title of 1988 Amendments note set out under section
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201 of this title and Tables. −COD− CODIFICATION Section was enacted as part of the AIDS Amendments of 1988 and as part of the Health Omnibus Programs Extension of 1988, and not as part of the Public Health Service Act which comprises this chapter. −MISC1− AMENDMENTS 1988 − Pub. L. 100−690 substituted "Surgeon General of the Public Health Service" for "Surgeon General of the United States". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−31 of this title. −End− −CITE− 42 USC Sec. 300ee−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD−
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Sec. 300ee−6. Transferred −COD− CODIFICATION Section, Pub. L. 100−607, title IX, Sec. 902, Nov. 4, 1988, 102 Stat. 3171; Pub. L. 100−690, title II, Sec. 2605(a), Nov. 18, 1988, 102 Stat. 4234, which provided for testing of State prisoners, was renumbered section 2648 of the Public Health Service Act by Pub. L. 101−381, title III, Sec. 301(b)(1), Aug. 18, 1990, 104 Stat. 615, and transferred to section 300ff−48 of this title, prior to repeal by Pub. L. 106−345, title III, Sec. 301(a), Oct. 20, 2000, 114 Stat. 1345. −End− −CITE− 42 USC Part A − Formula Grants to States 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− PART A − FORMULA GRANTS TO STATES −End− −CITE− 42 USC Sec. 300ee−11 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE
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CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−11. Establishment of program −STATUTE− (a) Allotments for States For the purpose described in subsection (b) of this section, the Secretary shall for each of the fiscal years 1989 through 1991 make an allotment for each State in an amount determined in accordance with section 300ee−17 of this title. The Secretary shall make payments each such fiscal year to each State from the allotment for the State if the Secretary approves for the fiscal year involved an application submitted by the State pursuant to section 300ee−13 of this title. (b) Purpose of grants The Secretary may not make payments under subsection (a) of this section for a fiscal year unless the State involved agrees to expend the payments only for the purpose of carrying out, in accordance with section 300ee−12 of this title, public information activities with respect to acquired immune deficiency syndrome. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2501, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3093; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
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−MISC1− PRIOR PROVISIONS A prior section 2501 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ee−12, 300ee−13, 300ee−14, 300ee−15, 300ee−16, 300ee−17, 300ee−18, 300ee−19, 300ee−20, 300ee−24 of this title. −End− −CITE− 42 USC Sec. 300ee−12 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−12. Provisions with respect to carrying out purpose of grants −STATUTE− A State may expend payments received under section 300ee−11(a) of this title − (1) to develop, establish, and conduct public information activities relating to the prevention and diagnosis of acquired immune deficiency syndrome for those populations or communities
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in the State in which there are a significant number of individuals at risk of infection with the etiologic agent for such syndrome; (2) to develop, establish, and conduct such public information activities for the general public relating to the prevention and diagnosis of such syndrome; (3) to develop, establish, and conduct activities to reduce risks relating to such syndrome, including research into the prevention of such syndrome; (4) to conduct demonstration projects for the prevention of such syndrome; (5) to provide technical assistance to public entities, to nonprofit private entities concerned with such syndrome, to schools, and to employers, for the purpose of developing information programs relating to such syndrome; (6) with respect to education and training programs for the prevention of such syndrome, to conduct such programs for health professionals (including allied health professionals), public safety workers (including emergency response employees), teachers, school administrators, and other appropriate education personnel; (7) to conduct appropriate programs for educating school−aged children with respect to such syndrome, after consulting with local school boards; (8) to make available to physicians and dentists in the State information with respect to acquired immune deficiency syndrome,
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including measures for the prevention of exposure to, and the transmission of, the etiologic agent for such syndrome (which information is updated not less than annually with the most recently available scientific date (!1) relating to such syndrome); (9) to carry out the initial implementation of recommendations contained in the guidelines and the model curriculum developed under section 300ee−2 of this title; and (10) to make grants to public entities, and to nonprofit private entities concerned with acquired immune deficiency syndrome, for the purpose of the development, establishment, and expansion of programs for education directed toward individuals at increased risk of infection with the etiologic agent for such syndrome and activities to reduce the risks of exposure to such etiologic agent, with preference to programs directed toward populations in which there is significant evidence of such infection. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2502, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3094; amended Pub. L. 100−690, title II, Sec. 2619(b), Nov. 18, 1988, 102 Stat. 4242; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2502 of act July 1, 1944, was successively
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renumbered by subsequent acts, see section 238a of this title. AMENDMENTS 1988 − Par. (9). Pub. L. 100−690 made technical amendment to reference to section 300ee−2 of this title to correct reference to corresponding provision of original act. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ee−11, 300ee−16 of this title. −FOOTNOTE− (!1) So in original. Probably should be "data". −End− −CITE− 42 USC Sec. 300ee−13 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−13. Requirement of submission of application containing
104
certain agreements and assurances −STATUTE− (a) In general The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless − (1) the State involved submits to the Secretary a description of the purposes for which the State intends to expend the payments for the fiscal year; (2) the description identifies the populations, areas, and localities in the State with a need for the services for which amounts may be provided by the State under this part; (3) the description provides information relating to the programs and activities to be supported and services to be provided, including a description of the manner in which such programs and activities will be coordinated with any similar programs and activities of public and private entities; (4) the State submits to the Secretary an application for the payments containing agreements in accordance with this part; (5) the agreements are made through certification from the chief executive officer of the State; (6) with respect to such agreements, the application provides assurances of compliance satisfactory to the Secretary; and (7) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this part.
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(b) Opportunity for public comment The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees that, in developing and carrying out the description required in subsection (a) of this section, the State will provide public notice with respect to the description (including any revisions) and will facilitate comments from interested persons. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2503, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3095; amended Pub. L. 100−690, title II, Sec. 2619(c), Nov. 18, 1988, 102 Stat. 4242; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2503 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238b of this title. AMENDMENTS 1988 − Subsec. (a)(3). Pub. L. 100−690 struck out "and" after semicolon. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −SECREF−
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SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ee−11, 300ee−15, 300ee−17, 300ee−18 of this title. −End− −CITE− 42 USC Sec. 300ee−14 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−14. Restrictions on use of grant −STATUTE− (a) In general The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees that the payments will not be expended − (1) to provide inpatient services; (2) to make cash payments to intended recipients of services; (3) to purchase or improve real property (other than minor remodeling of existing improvements to real property) or to purchase major medical equipment; or (4) to satisfy any requirement for the expenditure of non−Federal funds as a condition for the receipt of Federal funds.
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(b) Limitation on administrative expenses The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees that the State will not expend more than 5 percent of the payments for administrative expenses with respect to carrying out the purpose described in section 300ee−11(b) of this title. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2504, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3095; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2504 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238c of this title. −End− −CITE− 42 USC Sec. 300ee−15 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−15. Requirement of reports and audits by States −STATUTE−
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(a) Reports The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees to prepare and submit to the Secretary an annual report in such form and containing such information as the Secretary determines to be necessary for − (1) securing a record and a description of the purposes for which payments received by the State pursuant to such section were expended and of the recipients of such payments; (2) determining whether the payments were expended in accordance with the needs within the State required to be identified pursuant to section 300ee−13(a)(2) of this title; (3) determining whether the payments were expended in accordance with the purpose described in section 300ee−11(b) of this title; and (4) determining the percentage of payments received pursuant to such section that were expended by the State for administrative expenses during the preceding fiscal year. (b) Audits (1) The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees to establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the State under such section. (2) The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees
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that − (A) the State will provide for − (i) a financial and compliance audit of such payments; or (ii) a single financial and compliance audit of each entity administering such payments; (B) the audit will be performed biennially and will cover expenditures in each fiscal year; and (C) the audit will be conducted in accordance with standards established by the Comptroller General of the United States for the audit of governmental organizations, programs, activities, and functions. (3) The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees that, not later than 30 days after the completion of an audit under paragraph (2), the State will provide a copy of the audit report to the State legislature. (4) For purposes of paragraph (2), the term "financial and compliance audit" means an audit to determine whether the financial statements of an audited entity present fairly the financial position, and the results of financial operations, of the entity in accordance with generally accepted accounting principles, and whether the entity has complied with laws and regulations that may have a material effect upon the financial statements. (c) Availability to public The Secretary may not make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees to
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make copies of the reports and audits described in this section available for public inspection. (d) Evaluations by Comptroller General The Comptroller General of the United States shall, from time to time, evaluate the expenditures by States of payments received under section 300ee−11(a) of this title in order to ensure that expenditures are consistent with the provisions of this part. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2505, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3095; amended Pub. L. 100−690, title II, Sec. 2619(d), Nov. 18, 1988, 102 Stat. 4242; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2505 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238d of this title. AMENDMENTS 1988 − Subsec. (b)(1), (2). Pub. L. 100−690 substituted "make payments" for "payments". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −End−
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−CITE− 42 USC Sec. 300ee−16 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−16. Additional required agreements −STATUTE− (a) In general The Secretary may not, except as provided in subsection (b) of this section, make payments under section 300ee−11(a) of this title for a fiscal year unless the State involved agrees that − (1) all programs conducted or supported by the State with such payments will establish objectives for the program and will determine the extent to which the objectives are met; (2) information provided under this part will be scientifically accurate and factually correct; (3) in carrying out section 300ee−11(b) of this title, the State will give priority to programs described in section 300ee−12(10) of this title for individuals described in such section; (4) with respect to a State in which there is a substantial number of individuals who are intravenous substance abusers, the State will place priority on activities under this part directed
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at such substance abusers; (5) with respect to a State in which there is a significant incidence of reported cases of acquired immune deficiency syndrome, the State will − (A) for the purpose described in subsection (b) of section 300ee−11 of this title, expend not less than 50 percent of payments received under subsection (a) of such section for a fiscal year − (i) to make grants to public entities, to migrant health centers (as defined in section 254b(a) (!1) of this title), to community health centers (as defined in section 254c(a) (!1) of this title), and to nonprofit private entities concerned with acquired immune deficiency syndrome; or (ii) to enter into contracts with public and private entities; and (B) of the amounts reserved for a fiscal year by the State for expenditures required in subparagraph (A), expend not less than 50 percent to carry out section 300ee−12(10) of this title through grants to nonprofit private entities, including minority entities, concerned with acquired immune deficiency syndrome located in and representative of communities and subpopulations reflecting the local incidence of such syndrome; (6) with respect to programs carried out pursuant to section 300ee−12(10) of this title, the State will ensure that any applicant for a grant under such section agrees − (A) that any educational or informational materials developed
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with a grant pursuant to such section will contain material, and be presented in a manner, that is specifically directed toward the group for which such materials are intended; (B) to provide a description of the manner in which the applicant has planned the program in consultation with, and of the manner in which such applicant will consult during the conduct of the program with − (i) appropriate local officials and community groups for the area to be served by the program; (ii) organizations comprised of, and representing, the specific population to which the education or prevention effort is to be directed; and (iii) individuals having expertise in health education and in the needs of the population to be served; (C) to provide information demonstrating that the applicant has continuing relationships, or will establish continuing relationships, with a portion of the population in the service area that is at risk of infection with the etiologic agent for acquired immune deficiency syndrome and with public and private entities in such area that provide health or other support services to individuals with such infection; (D) to provide a description of − (i) the objectives established by the applicant for the conduct of the program; and (ii) the methods the applicant will use to evaluate the activities conducted under the program to determine if such
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objectives are met; and (E) such other information as the Secretary may prescribe; (7) with respect to programs carried out pursuant to section 300ee−12(10) of this title, the State will give preference to any applicant for a grant pursuant to such section that is located in, has a history of service in, and will serve under the program, any geographic area in which − (A) there is a significant incidence of acquired immune deficiency syndrome; (B) there has been a significant increase in the incidence of such syndrome; or (C) there is a significant risk of becoming infected with the etiologic agent for such syndrome; (8) the State will establish reasonable criteria to evaluate the effective performance of entities that receive funds from payments made to the State under section 300ee−11(a) of this title and will establish procedures for procedural and substantive independent State review of the failure by the State to provide funds for any such entity; (9) the State will permit and cooperate with Federal investigations undertaken in accordance with section 300ee−18(e) of this title; (10) the State will maintain State expenditures for services provided pursuant to section 300ee−11 of this title at a level equal to not less than the average level of such expenditures maintained by the State for the 2−year period preceding the
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fiscal year for which the State is applying to receive payments. (b) "Significant percentage" defined For purposes of subsection (a)(5) of this section, the term "significant percentage" means at least a percentage of 1 percent of the number of reported cases of acquired immune deficiency syndrome in the United States. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2506, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3097; amended Pub. L. 100−690, title II, Sec. 2619(d) [(e)], Nov. 18, 1988, 102 Stat. 4243; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −REFTEXT− REFERENCES IN TEXT Sections 254b and 254c of this title, referred to in subsec. (a)(5)(A)(i), were in the original references to sections 329 and 330, meaning sections 329 and 330 of act July 1, 1944, which were omitted in the general amendment of subpart I (Sec. 254b et seq.) of part D of subchapter II of this chapter by Pub. L. 104−299, Sec. 2, Oct. 11, 1996, 110 Stat. 3626. Sections 2 and 3(a) of Pub. L. 104−299 enacted new sections 330 and 330A of act July 1, 1944, which are classified, respectively, to sections 254b and 254c of this title. −MISC1− PRIOR PROVISIONS A prior section 2506 of act July 1, 1944, was successively
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renumbered by subsequent acts, see section 238e of this title. AMENDMENTS 1988 − Subsec. (a). Pub. L. 100−690, Sec. 2619(d)(1) [(e)(1)], designated existing provisions as subsec. (a). Subsec. (a)(5). Pub. L. 100−690, Sec. 2619(d)(2) [(e)(2)], struck out concluding provisions which read as follows: "(For purposes of this section, the term 'significant percentage' means at least a percentage of 1 percent of the number of reported cases of such syndrome in the United States);". Subsec. (a)(8). Pub. L. 100−690, Sec. 2619(d)(3) [(e)(3)], substituted "funds from payments" for "funds from to payments" and struck out "and" after semicolon. Subsec. (a)(9). Pub. L. 100−690, Sec. 2619(d)(4) [(e)(4)], substituted "section 300ee−18(e) of this title" for "section 300ee−19(e) of this title". Subsec. (b). Pub. L. 100−690, Sec. 2619(d)(5) [(e)(5)], added subsec. (b). EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING, OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER Reference to community health center, migrant health center, public housing health center, or homeless health center considered
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reference to health center, see section 4(c) of Pub. L. 104−299, set out as a note under section 254b of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ee−17 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−17. Determination of amount of allotments for States −STATUTE− (a) Minimum allotment Subject to the extent of amounts made available in appropriation Acts, the allotment for a State under section 300ee−11(a) of this title for a fiscal year shall be the greater of − (1) the applicable amount specified in subsection (b) of this section; or (2) the amount determined in accordance with subsection (c) of this section. (b) Determination of minimum allotment (1) If the total amount appropriated under section 300ee−24(a) of this title for a fiscal year exceeds $100,000,000, the amount
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referred to in subsection (a)(1) of this section shall be $300,000 for the fiscal year. (2) If the total amount appropriated under section 300ee−24(a) of this title for a fiscal year equals or exceeds $50,000,000, but is less than $100,000,000, the amount referred to in subsection (a)(1) of this section shall be $200,000 for the fiscal year. (3) If the total amount appropriated under section 300ee−24(a) of this title for a fiscal year is less than $50,000,000, the amount referred to in subsection (a)(1) of this section shall be $100,000 for the fiscal year. (c) Determination under formula (1) The amount referred to in subsection (a)(2) of this section is the sum of − (A) the amount determined under paragraph (2); and (B) the amount determined under paragraph (3). (2) The amount referred to in paragraph (1)(A) is the product of − (A) an amount equal to 50 percent of the amounts appropriated pursuant to section 300ee−24(a) of this title; and (B) a percentage equal to the quotient of − (i) the population of the State involved; divided by (ii) the population of the United States. (3) The amount referred to in paragraph (1)(B) is the product of − (A) an amount equal to 50 percent of the amounts appropriated pursuant to section 300ee−24(a) of this title; and
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(B) a percentage equal to the quotient of − (i) the number of additional cases of acquired immune deficiency syndrome reported to and confirmed by the Secretary for the State involved for the most recent fiscal year for which such data is available; divided by (ii) the number of additional cases of such syndrome reported to and confirmed by the Secretary for the United States for such fiscal year. (d) Disposition of certain funds appropriated for allotments (1) Amounts described in paragraph (2) shall be allotted by the Secretary to States receiving payments under section 300ee−11(a) of this title for the fiscal year (other than any State referred to in paragraph (2)(C)). Such amounts shall be allotted according to a formula established by the Secretary. The formula shall be equivalent to the formula described in this section under which the allotment under section 300ee−11(a) of this title for the State for the fiscal year involved was determined. (2) The amounts referred to in paragraph (1) are any amounts that are not paid to States under section 300ee−11(a) of this title as a result of − (A) the failure of any State to submit an application under section 300ee−13 of this title; (B) the failure, in the determination of the Secretary, of any State to prepare within a reasonable period of time such application in compliance with such section; or (C) any State informing the Secretary that the State does not
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intend to expend the full amount of the allotment made to the State. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2507, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3098; amended Pub. L. 100−690, title II, Sec. 2619(e) [(f)], Nov. 18, 1988, 102 Stat. 4243; renumbered title XXV and amended Pub. L. 101−93, Sec. 5(e)(1), (2), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2507 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238f of this title. AMENDMENTS 1989 − Subsec. (a). Pub. L. 101−93, Sec. 5(e)(2), substituted "Subject to the extent of amounts made available in appropriation Acts, the allotment" for "The allotment". 1988 − Subsec. (a)(1). Pub. L. 100−690, Sec. 2619(e)(1) [(f)(1)], substituted "applicable amount specified" for "amount described". Subsec. (b)(1). Pub. L. 100−690, Sec. 2619(e)(2)(A)(i) [(f)(2)(A)(i)], made technical amendment to reference to section 300ee−24(a) of this title to correct reference to corresponding provision of original act. Pub. L. 100−690, Sec. 2619(e)(2)(A)(ii) [(f)(2)(A)(ii)], substituted "subsection (a)(1) of this section shall be" for "subsection (a)(1) of this section is". Subsec. (b)(2), (3). Pub. L. 100−690, Sec. 2619(e)(2)(B), (C)
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[(f)(2)(B), (C)], substituted "subsection (a)(1) of this section shall be" for "subsection (a)(1) of this section is". Subsec. (d). Pub. L. 100−690, Sec. 2619(e)(3) [(f)(3)], substituted "allotment under section 300ee−11(a) of this title" for "allotment" in par. (1) and "section 300ee−13 of this title" for "section 300ee−17 of this title" in par. (2)(A). EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ee−11 of this title. −End− −CITE− 42 USC Sec. 300ee−18 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−18. Failure to comply with agreements −STATUTE− (a) Repayment of payments
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(1) The Secretary may, subject to subsection (c) of this section, require a State to repay any payments received by the State under section 300ee−11(a) of this title that the Secretary determines were not expended by the State in accordance with the agreements required to be contained in the application submitted by the State pursuant to section 300ee−13 of this title. (2) If a State fails to make a repayment required in paragraph (1), the Secretary may offset the amount of the repayment against the amount of any payment due to be paid to the State under section 300ee−11(a) of this title. (b) Withholding of payments (1) The Secretary may, subject to subsection (c) of this section, withhold payments due under section 300ee−11(a) of this title if the Secretary determines that the State involved is not expending amounts received under such section in accordance with the agreements required to be contained in the application submitted by the State pursuant to section 300ee−13 of this title. (2) The Secretary shall cease withholding payments from a State under paragraph (1) if the Secretary determines that there are reasonable assurances that the State will expend amounts received under section 300ee−11(a) of this title in accordance with the agreements referred to in such paragraph. (3) The Secretary may not withhold funds under paragraph (1) from a State for a minor failure to comply with the agreements referred to in such paragraph. (c) Opportunity for hearing
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Before requiring repayment of payments under subsection (a)(1) of this section, or withholding payments under subsection (b)(1) of this section, the Secretary shall provide to the State an opportunity for a hearing conducted within the State. (d) Prompt response to serious allegations The Secretary shall promptly respond to any complaint of a substantial or serious nature that a State has failed to expend amounts received under section 300ee−11(a) of this title in accordance with the agreements required to be contained in the application submitted by the State pursuant to section 300ee−13 of this title. (e) Investigations (1) The Secretary shall conduct in several States in each fiscal year investigations of the expenditure of payments received by the States under section 300ee−11(a) of this title in order to evaluate compliance with the agreements required to be contained in the applications submitted to the Secretary pursuant to section 300ee−13 of this title. (2) The Comptroller General of the United States may conduct investigations of the expenditure of funds received under section 300ee−11(a) of this title by a State in order to ensure compliance with the agreements referred to in paragraph (1). (3) Each State, and each entity receiving funds from payments made to a State under section 300ee−11(a) of this title, shall make appropriate books, documents, papers, and records available to the Secretary and the Comptroller General of the United States, or any
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of their duly authorized representatives, for examination, copying, or mechanical reproduction on or off the premises of the appropriate entity upon a reasonable request therefor. (4)(A) In conducting any investigation in a State, the Secretary and the Comptroller General of the United States may not make a request for any information not readily available to the State, or to an entity receiving funds from payments made to the State under section 300ee−11(a) of this title, or make an unreasonable request for information to be compiled, collected, or transmitted in any form not readily available. (B) Subparagraph (A) shall not apply to the collection, compilation, or transmittal of data in the course of a judicial proceeding. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2508, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3099; amended Pub. L. 100−690, title II, Sec. 2619(f) [(g)], Nov. 18, 1988, 102 Stat. 4243; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2508 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238g of this title. AMENDMENTS 1988 − Subsec. (a). Pub. L. 100−690, Sec. 2619(f)(1) [(g)(1)], substituted "300ee−13 of this title" for "300ee−17 of this title".
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Subsec. (b). Pub. L. 100−690, Sec. 2619(f)(2) [(g)(2)], inserted "of payments" after "Withholding" in heading and substituted "300ee−13 of this title" for "300ee−17 of this title" in par. (1). Subsecs. (d), (e)(1). Pub. L. 100−690, Sec. 2619(f)(3), (4) [(g)(3), (4)], substituted "300ee−13 of this title" for "300ee−17 of this title". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ee−16 of this title. −End− −CITE− 42 USC Sec. 300ee−19 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−19. Prohibition against certain false statements −STATUTE− (a) In general
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(1) A person may not knowingly make or cause to be made any false statement or representation of a material fact in connection with the furnishing of items or services for which amounts may be paid by a State from payments received by the State under section 300ee−11(a) of this title. (2) A person with knowledge of the occurrence of any event affecting the right of the person to receive any amounts from payments made to the State under section 300ee−11(a) of this title may not conceal or fail to disclose any such event with the intent of fraudulently securing such amounts. (b) Criminal penalty for violation of prohibition Any person who violates a prohibition established in subsection (a) of this section may for each violation be fined in accordance with title 18, or imprisoned for not more than 5 years, or both. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2509, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3101; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2509 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238h of this title. −End− −CITE− 42 USC Sec. 300ee−20 01/06/03
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−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−20. Technical assistance and provision by Secretary of supplies and services in lieu of grant funds −STATUTE− (a) Technical assistance The Secretary may provide training and technical assistance to States with respect to the planning, development, and operation of any program or service carried out pursuant to this part. The Secretary may provide such technical assistance directly or through grants or contracts. (b) Provision by Secretary of supplies and services in lieu of grant funds (1) Upon the request of a State receiving payments under this part, the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the State in carrying out such part and, for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services. (2) With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments under section 300ee−11(a) of this title to the State by an amount equal to the
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costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2510, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3101; amended Pub. L. 100−690, title II, Sec. 2619(g) [(h)], Nov. 18, 1988, 102 Stat. 4243; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2510 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238i of this title. AMENDMENTS 1988 − Subsec. (b)(2). Pub. L. 100−690 substituted "section 300ee−11(a) of this title" for "the program involved". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −End− −CITE− 42 USC Sec. 300ee−21 01/06/03 −EXPCITE−
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TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−21. Evaluations −STATUTE− The Secretary shall, directly or through grants or contracts, evaluate the services provided and activities carried out with payments to States under this part. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2511, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3101; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2511 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238j of this title. −End− −CITE− 42 USC Sec. 300ee−22 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
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Part A − Formula Grants to States −HEAD− Sec. 300ee−22. Report by Secretary −STATUTE− The Secretary shall annually prepare a report on the activities of the States carried out pursuant to this part. Such report may include any recommendations of the Secretary for appropriate administrative and legislative initiatives. The report shall be submitted to the Congress through inclusion in the comprehensive report required in section 300cc(a) of this title. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2512, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3101; amended Pub. L. 100−690, title II, Sec. 2619(h) [(i)], Nov. 18, 1988, 102 Stat. 4243; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2512 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238k of this title. AMENDMENTS 1988 − Pub. L. 100−690 substituted "section 300cc(a)" for "section 300cc". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see
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section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −End− −CITE− 42 USC Sec. 300ee−23 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−23. Definition −STATUTE− For purposes of this part, the term "infection with the etiologic agent for acquired immune deficiency syndrome" includes any condition arising from such etiologic agent. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2513, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3102; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1− PRIOR PROVISIONS A prior section 2513 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238l of this title. −End−
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−CITE− 42 USC Sec. 300ee−24 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Formula Grants to States −HEAD− Sec. 300ee−24. Funding −STATUTE− (a) Authorization of appropriations For the purpose of making allotments under section 300ee−11(a) of this title, there are authorized to be appropriated $165,000,000 for fiscal year 1989 and such sums as may be necessary for each of the fiscal years 1990 and 1991. (b) Availability to States Any amounts paid to a State under section 300ee−11(a) of this title shall remain available to the State until the expiration of the 1−year period beginning on the date on which the State receives such amounts. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2514, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3102; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.) −MISC1−
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PRIOR PROVISIONS A prior section 2514 of act July 1, 1944, was successively renumbered by subsequent acts, see section 238m of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ee−17 of this title. −End− −CITE− 42 USC Part B − National Information Programs 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − National Information Programs −HEAD− PART B − NATIONAL INFORMATION PROGRAMS −End− −CITE− 42 USC Sec. 300ee−31 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − National Information Programs −HEAD− Sec. 300ee−31. Availability of information to general public
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−STATUTE− (a) Comprehensive information plan The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall annually prepare a comprehensive plan, including a budget, for a National Acquired Immune Deficiency Syndrome Information Program. The plan shall contain provisions to implement the provisions of this subchapter. The Director shall submit such plan to the Secretary. The authority established in this subsection may not be construed to be the exclusive authority for the Director to carry out information activities with respect to acquired immune deficiency syndrome. (b) Clearinghouse (1) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may establish a clearinghouse to make information concerning acquired immune deficiency syndrome available to Federal agencies, States, public and private entities, and the general public. (2) The clearinghouse may conduct or support programs − (A) to develop and obtain educational materials, model curricula, and methods directed toward reducing the transmission of the etiologic agent for acquired immune deficiency syndrome; (B) to provide instruction and support for individuals who provide instruction in methods and techniques of education relating to the prevention of acquired immune deficiency syndrome and instruction in the use of the materials and curricula described in subparagraph (A); and
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(C) to conduct, or to provide for the conduct of, the materials, curricula, and methods described in paragraph (1) and the efficacy of such materials, curricula, and methods in preventing infection with the the (!1) etiologic agent for acquired immune deficiency syndrome. (c) Toll−free telephone communications The Secretary shall provide for the establishment and maintenance of toll−free telephone communications to provide information to, and respond to queries from, the public concerning acquired immune deficiency syndrome. Such communications shall be available on a 24−hour basis. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2521, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3102; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612; amended Pub. L. 102−531, title III, Sec. 312(d)(22), Oct. 27, 1992, 106 Stat. 3505.) −MISC1− AMENDMENTS 1992 − Subsecs. (a), (b)(1). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ee−34 of this title. −FOOTNOTE−
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(!1) So in original. −End− −CITE− 42 USC Sec. 300ee−32 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − National Information Programs −HEAD− Sec. 300ee−32. Public information campaigns −STATUTE− (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to public entities, and to nonprofit private entities concerned with acquired immune deficiency syndrome, and shall enter into contracts with public and private entities, for the development and delivery of public service announcements and paid advertising messages that warn individuals about activities which place them at risk of infection with the etiologic agent for such syndrome. (b) Requirement of application The Secretary may not provide financial assistance under subsection (a) of this section unless − (1) an application for such assistance is submitted to the Secretary;
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(2) with respect to carrying out the purpose for which the assistance is to be provided, the application provides assurances of compliance satisfactory to the Secretary; and (3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2522, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3103; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612; amended Pub. L. 102−531, title III, Sec. 312(d)(23), Oct. 27, 1992, 106 Stat. 3505.) −MISC1− AMENDMENTS 1992 − Subsec. (a). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ee−34 of this title. −End− −CITE− 42 USC Sec. 300ee−33 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE
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SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − National Information Programs −HEAD− Sec. 300ee−33. Provision of information to underserved populations −STATUTE− (a) In general The Secretary may make grants to public entities, to migrant health centers (as defined in section 254b(a) (!1) of this title), to community health centers (as defined in section 254c(a) (!1) of this title), and to nonprofit private entities concerned with acquired immune deficiency syndrome, for the purpose of assisting grantees in providing services to populations of individuals that are underserved with respect to programs providing information on the prevention of exposure to, and the transmission of, the etiologic agent for acquired immune deficiency syndrome. (b) Preferences in making grants In making grants under subsection (a) of this section, the Secretary shall give preference to any applicant for such a grant that has the ability to disseminate rapidly the information described in subsection (a) of this section (including any national organization with such ability). −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2523, as added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3103; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612.)
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−REFTEXT− REFERENCES IN TEXT Sections 254b and 254c of this title, referred to in subsec. (a), were in the original references to sections 329 and 330, meaning sections 329 and 330 of act July 1, 1944, which were omitted in the general amendment of subpart I (Sec. 254b et seq.) of part D of subchapter II of this chapter by Pub. L. 104−299, Sec. 2, Oct. 11, 1996, 110 Stat. 3626. Sections 2 and 3(a) of Pub. L. 104−299 enacted new sections 330 and 330A of act July 1, 1944, which are classified, respectively, to sections 254b and 254c of this title. −MISC1− REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING, OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER Reference to community health center, migrant health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104−299, set out as a note under section 254b of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ee−34 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ee−34 01/06/03 −EXPCITE−
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TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIII − PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − National Information Programs −HEAD− Sec. 300ee−34. Authorization of appropriations −STATUTE− (a) In general For the purpose of carrying out sections 300ee−31 through 300ee−33 of this title, there are authorized to be appropriated $105,000,000 for fiscal year 1989 and such sums as may be necessary for each of the fiscal years 1990 and 1991. (b) Allocations (1) Of the amounts appropriated pursuant to subsection (a) of this section, the Secretary shall make available $45,000,000 to carry out section 300ee−32 of this title and $30,000,000 to carry out this part through financial assistance to minority entities for the provision of services to minority populations. (2) After consultation with the Director of the Office of Minority Health and with the Indian Health Service, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, not later than 90 days after November 4, 1988, publish guidelines to provide procedures for applications for funding pursuant to paragraph (1) and for public comment. −SOURCE− (July 1, 1944, ch. 373, title XXV, formerly title XV, Sec. 2524, as
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added Pub. L. 100−607, title II, Sec. 221, Nov. 4, 1988, 102 Stat. 3103; amended Pub. L. 100−690, title II, Sec. 2619(i) [(j)], Nov. 18, 1988, 102 Stat. 4244; renumbered title XXV, Pub. L. 101−93, Sec. 5(e)(1), Aug. 16, 1989, 103 Stat. 612; Pub. L. 102−531, title III, Sec. 312(d)(24), Oct. 27, 1992, 106 Stat. 3505.) −MISC1− AMENDMENTS 1992 − Subsec. (b)(2). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". 1988 − Subsec. (b)(2). Pub. L. 100−690 substituted "the date of the enactment of the AIDS Amendments of 1988" for "the date of the enactment of this section", which for purposes of codification was translated as "November 4, 1988". EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section 242m of this title. −End− −CITE− 42 USC SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM −HEAD−
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SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM −SECREF− SUBCHAPTER REFERRED TO IN OTHER SECTIONS This subchapter is referred to in sections 247c−2, 256b, 256d of this title. −End− −CITE− 42 USC Sec. 300ff 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM −HEAD− Sec. 300ff. Purpose −STATUTE− It is the purpose of this Act to provide emergency assistance to localities that are disproportionately affected by the Human Immunodeficiency Virus epidemic and to make financial assistance available to States and other public or private nonprofit entities to provide for the development, organization, coordination and operation of more effective and cost efficient systems for the delivery of essential services to individuals and families with HIV disease. −SOURCE− (Pub. L. 101−381, Sec. 2, Aug. 18, 1990, 104 Stat. 576.) −REFTEXT−
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REFERENCES IN TEXT This Act, referred to in text, is Pub. L. 101−381, Aug. 18, 1990, 104 Stat. 576, known as the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, which enacted this subchapter, transferred section 300ee−6 of this title to section 300ff−48 of this title, amended sections 284a, 286, 287a, 287c−2, 289f, 290aa−3a, 299c−5, 300ff−48, and 300aaa to 300aaa−13 [now 238 to 238m] of this title, and enacted provisions set out as notes under sections 201, 300x−4, 300ff−11, 300ff−46, and 300ff−80 of this title. For complete classification of this Act to the Code, see Short Title of 1990 Amendment note set out under section 201 of this title and Tables. −COD− CODIFICATION Section was enacted as part of the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, and not as part of the Public Health Service Act which comprises this chapter. −End− −CITE− 42 USC Sec. 300ff−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM −HEAD− Sec. 300ff−1. Prohibition on use of funds −STATUTE−
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None of the funds made available under this Act, or an amendment made by this Act, shall be used to provide individuals with hypodermic needles or syringes so that such individuals may use illegal drugs. −SOURCE− (Pub. L. 101−381, title IV, Sec. 422, Aug. 18, 1990, 104 Stat. 628.) −REFTEXT− REFERENCES IN TEXT This Act, referred to in text, is Pub. L. 101−381, Aug. 18, 1990, 104 Stat. 576, known as the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, which enacted this subchapter, transferred section 300ee−6 of this title to section 300ff−48 of this title, amended sections 284a, 286, 287a, 287c−2, 289f, 290aa−3a, 299c−5, 300ff−48, and 300aaa to 300aaa−13 [now 238 to 238m] of this title, and enacted provisions set out as notes under sections 201, 300x−4, 300ff−11, 300ff−46, and 300ff−80 of this title. For complete classification of this Act to the Code, see Short Title of 1990 Amendment note set out under section 201 of this title and Tables. −COD− CODIFICATION Section was enacted as part of the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, and not as part of the Public Health Service Act which comprises this chapter. −End− −CITE−
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42 USC Part A − Emergency Relief for Areas With Substantial Need for Services 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− PART A − EMERGENCY RELIEF FOR AREAS WITH SUBSTANTIAL NEED FOR SERVICES −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in sections 300ff−28, 300ff−30, 300ff−51, 300ff−75, 300ff−75b, 300ff−77, 300ff−101 of this title. −End− −CITE− 42 USC Sec. 300ff−11 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−11. Establishment of program of grants
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−STATUTE− (a) Eligible areas The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall, subject to subsections (b) through (d) of this section, make grants in accordance with section 300ff−13 of this title for the purpose of assisting in the provision of the services specified in section 300ff−14 of this title in any metropolitan area for which there has been reported to the Director of the Centers for Disease Control and Prevention a cumulative total of more than 2,000 cases of acquired immune deficiency syndrome for the most recent period of 5 calendar years for which such data are available. (b) Requirement regarding confirmation of cases The Secretary may not make a grant under subsection (a) of this section for a metropolitan area unless, before making any payments under the grant, the cases of acquired immune deficiency syndrome reported for purposes of such subsection have been confirmed by the Secretary, acting through the Director of the Centers for Disease Control and Prevention. (c) Requirements regarding population (1) Number of individuals (A) In general Except as provided in subparagraph (B), the Secretary may not make a grant under this section for a metropolitan area unless the area has a population of 500,000 or more individuals. (B) Limitation
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Subparagraph (A) does not apply to any metropolitan area that was an eligible area under this part for fiscal year 1995 or any prior fiscal year. (2) Geographic boundaries For purposes of eligibility under this part, the boundaries of each metropolitan area are the boundaries that were in effect for the area for fiscal year 1994. (d) Continued status as eligible area Notwithstanding any other provision of this section, a metropolitan area that was an eligible area under this part for fiscal year 1996 is an eligible area for fiscal year 1997 and each subsequent fiscal year. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2601, as added Pub. L. 101−381, title I, Sec. 101(3), Aug. 18, 1990, 104 Stat. 576; amended Pub. L. 102−531, title III, Sec. 312(d)(25), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 104−146, Secs. 3(a)(1), (2), 12(c)(1), May 20, 1996, 110 Stat. 1346, 1373.) −MISC1− PRIOR PROVISIONS A prior section 2601 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238 of this title. AMENDMENTS 1996 − Subsec. (a). Pub. L. 104−146, Sec. 12(c)(1), inserted "section" before "300ff−14".
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Pub. L. 104−146, Sec. 3(a)(1)(B), substituted "metropolitan area for which there has been reported to the Director of the Centers for Disease Control and Prevention a cumulative total of more than 2,000 cases of acquired immune deficiency syndrome for the most recent period of 5 calendar years for which such data are available." for "metropolitan area for which, as of June 30, 1990, in the case of grants for fiscal year 1991, and as of March 31 of the most recent fiscal year for which such data is available in the case of a grant for any subsequent fiscal year − "(1) there has been reported to and confirmed by the Director of the Centers for Disease Control and Prevention a cumulative total of more than 2,000 cases of acquired immune deficiency syndrome; or "(2) the per capita incidence of cumulative cases of such syndrome (computed on the basis of the most recently available data on the population of the area) is not less than 0.0025." Pub. L. 104−146, Sec. 3(a)(1)(A), substituted "subject to subsections (b) through (d)" for "subject to subsection (b)". Subsecs. (c), (d). Pub. L. 104−146, Sec. 3(a)(2), added subsecs. (c) and (d). 1992 − Subsecs. (a)(1), (b). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". EFFECTIVE DATE OF 1996 AMENDMENT Section 13 of Pub. L. 104−146 provided that: "(a) In General. − Except as provided in subsection (b), this Act
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[enacting sections 300ff−27a, 300ff−31, 300ff−33 to 300ff−37, 300ff−77, 300ff−78, and 300ff−101 of this title, amending this section and sections 294n, 300d, 300ff−12 to 300ff−17, 300ff−21 to 300ff−23, 300ff−26 to 300ff−29, 300ff−47 to 300ff−49, 300ff−51, 300ff−52, 300ff−54, 300ff−55, 300ff−64, 300ff−71, 300ff−74, 300ff−76, and 300ff−84 of this title, transferring section 294n of this title to section 300ff−111 of this title, repealing sections 300ff−18 and 300ff−30 of this title, and enacting provisions set out as notes under sections 201, 300cc, and 300ff−33 of this title and section 4103 of Title 5, Government Organization and Employees], and the amendments made by this Act, shall become effective on October 1, 1996. "(b) Exception. − The amendments made by sections 3(a), 5, 6, and 7 of this Act to sections 2601(c), 2601(d), 2603(a), 2618(b), 2626, 2677, and 2691 of the Public Health Service Act [sections 300ff−11(c), (d), 300ff−13(a), 300ff−28(b), 300ff−34, 300ff−77, and 300ff−101 of this title], shall become effective on the date of enactment of this Act [May 20, 1996]." STUDIES BY INSTITUTE OF MEDICINE Pub. L. 106−345, title V, Sec. 501, Oct. 20, 2000, 114 Stat. 1352, provided that: "(a) State Surveillance Systems on Prevalence of HIV. − The Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study to provide the following:
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"(1) A determination of whether the surveillance system of each of the States regarding the human immunodeficiency virus provides for the reporting of cases of infection with the virus in a manner that is sufficient to provide adequate and reliable information on the number of such cases and the demographic characteristics of such cases, both for the State in general and for specific geographic areas in the State. "(2) A determination of whether such information is sufficiently accurate for purposes of formula grants under parts A and B of title XXVI of the Public Health Service Act [this part and part B of this subchapter]. "(3) With respect to any State whose surveillance system does not provide adequate and reliable information on cases of infection with the virus, recommendations regarding the manner in which the State can improve the system. "(b) Relationship Between Epidemiological Measures and Health Care for Certain Individuals With HIV Disease. − "(1) In general. − The Secretary shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study concerning the appropriate epidemiological measures and their relationship to the financing and delivery of primary care and health−related support services for low−income, uninsured, and under−insured individuals with HIV disease. "(2) Issues to be considered. − The Secretary shall ensure that the study under paragraph (1) considers the following:
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"(A) The availability and utility of health outcomes measures and data for HIV primary care and support services and the extent to which those measures and data could be used to measure the quality of such funded services. "(B) The effectiveness and efficiency of service delivery (including the quality of services, health outcomes, and resource use) within the context of a changing health care and therapeutic environment, as well as the changing epidemiology of the epidemic, including determining the actual costs, potential savings, and overall financial impact of modifying the program under title XIX of the Social Security Act [section 1396 et seq. of this title] to establish eligibility for medical assistance under such title on the basis of infection with the human immunodeficiency virus rather than providing such assistance only if the infection has progressed to acquired immune deficiency syndrome. "(C) Existing and needed epidemiological data and other analytic tools for resource planning and allocation decisions, specifically for estimating severity of need of a community and the relationship to the allocations process. "(D) Other factors determined to be relevant to assessing an individual's or community's ability to gain and sustain access to quality HIV services. "(c) Other Entities. − If the Institute of Medicine declines to conduct a study under this section, the Secretary shall enter into an agreement with another appropriate public or nonprofit private
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entity to conduct the study. "(d) Report. − The Secretary shall ensure that − "(1) not later than 3 years after the date of the enactment of this Act [Oct. 20, 2000], the study required in subsection (a) is completed and a report describing the findings made in the study is submitted to the appropriate committees of the Congress; and "(2) not later than 2 years after the date of the enactment of this Act, the study required in subsection (b) is completed and a report describing the findings made in the study is submitted to such committees." STUDY REGARDING HIV DISEASE IN RURAL AREAS Pub. L. 101−381, title IV, Sec. 403, Aug. 18, 1990, 104 Stat. 622 directed Secretary of Health and Human Services, after consultation with Director of the Office of Rural Health Policy, to conduct study for purpose of estimating incidence and prevalence in rural areas of cases of acquired immune deficiency syndrome and cases of infection with etiologic agent for such syndrome and determine adequacy in rural areas of services for diagnosing and providing treatment for such cases that are in early stages of infection, and provided that, not later than 1 year after Aug. 18, 1990, Secretary was to submit report to Congress. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−12, 300ff−13, 300ff−14, 300ff−15, 300ff−16, 300ff−17 of this title. −End−
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−CITE− 42 USC Sec. 300ff−12 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−12. Administration and planning council −STATUTE− (a) Administration (1) In general Assistance made available under grants awarded under this part shall be directed to the chief elected official of the city or urban county that administers the public health agency that provides outpatient and ambulatory services to the greatest number of individuals with AIDS, as reported to and confirmed by the Centers for Disease Control and Prevention, in the eligible area that is awarded such a grant. (2) Requirements (A) In general To receive assistance under section 300ff−11(a) of this title, the chief elected official of the eligible area involved shall − (i) establish, through intergovernmental agreements with
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the chief elected officials of the political subdivisions described in subparagraph (B), an administrative mechanism to allocate funds and services based on − (I) the number of AIDS cases in such subdivisions; (II) the severity of need for outpatient and ambulatory care services in such subdivisions; and (III) the health and support services personnel needs of such subdivisions; and (ii) establish an HIV health services planning council in accordance with subsection (b) of this section. (B) Local political subdivision The political subdivisions referred to in subparagraph (A) are those political subdivisions in the eligible area − (i) that provide HIV−related health services; and (ii) for which the number of cases reported for purposes of section 300ff−11(a) of this title constitutes not less than 10 percent of the number of such cases reported for the eligible area. (b) HIV health services planning council (1) Establishment To be eligible for assistance under this part, the chief elected official described in subsection (a)(1) of this section shall establish or designate an HIV health services planning council that shall reflect in its composition the demographics of the population of individuals with HIV disease in the eligible area involved, with particular consideration given to
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disproportionately affected and historically underserved groups and subpopulations. Nominations for membership on the council shall be identified through an open process and candidates shall be selected based on locally delineated and publicized criteria. Such criteria shall include a conflict−of−interest standard that is in accordance with paragraph (5). (2) Representation The HIV health services planning council shall include representatives of − (A) health care providers, including federally qualified health centers; (B) community−based organizations serving affected populations and AIDS service organizations; (C) social service providers, including providers of housing and homeless services; (D) mental health and substance abuse providers; (E) local public health agencies; (F) hospital planning agencies or health care planning agencies; (G) affected communities, including people with HIV disease and historically underserved groups and subpopulations; (H) nonelected community leaders; (I) State government (including the State medicaid agency and the agency administering the program under part B) of this subchapter; (J) grantees under subpart II (!1) of part C of this
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subchapter; (K) grantees under section 300ff−71 of this title, or, if none are operating in the area, representatives of organizations with a history of serving children, youth, women, and families living with HIV and operating in the area; (L) grantees under other Federal HIV programs, including but not limited to providers of HIV prevention services; and (M) representatives of individuals who formerly were Federal, State, or local prisoners, were released from the custody of the penal system during the preceding 3 years, and had HIV disease as of the date on which the individuals were so released. (3) Method of providing for council (A) In general In providing for a council for purposes of paragraph (1), a chief elected official receiving a grant under section 300ff−11(a) of this title may establish the council directly or designate an existing entity to serve as the council, subject to subparagraph (B). (B) Consideration regarding designation of council In making a determination of whether to establish or designate a council under subparagraph (A), a chief elected official receiving a grant under section 300ff−11(a) of this title shall give priority to the designation of an existing entity that has demonstrated experience in planning for the HIV health care service needs within the eligible area and in the
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implementation of such plans in addressing those needs. Any existing entity so designated shall be expanded to include a broad representation of the full range of entities that provide such services within the geographic area to be served. (4) Duties The planning council established or designated under paragraph (1) shall − (A) determine the size and demographics of the population of individuals with HIV disease; (B) determine the needs of such population, with particular attention to − (i) individuals with HIV disease who know their HIV status and are not receiving HIV−related services; and (ii) disparities in access and services among affected subpopulations and historically underserved communities; (C) establish priorities for the allocation of funds within the eligible area, including how best to meet each such priority and additional factors that a grantee should consider in allocating funds under a grant based on the − (i) size and demographics of the population of individuals with HIV disease (as determined under subparagraph (A)) and the needs of such population (as determined under subparagraph (B)); (ii) demonstrated (or probable) cost effectiveness and outcome effectiveness of proposed strategies and interventions, to the extent that data are reasonably
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available; (iii) priorities of the communities with HIV disease for whom the services are intended; (iv) coordination in the provision of services to such individuals with programs for HIV prevention and for the prevention and treatment of substance abuse, including programs that provide comprehensive treatment for such abuse; (v) availability of other governmental and non−governmental resources, including the State medicaid plan under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] and the State Children's Health Insurance Program under title XXI of such Act [42 U.S.C. 1397aa et seq.] to cover health care costs of eligible individuals and families with HIV disease; and (vi) capacity development needs resulting from disparities in the availability of HIV−related services in historically underserved communities; (D) develop a comprehensive plan for the organization and delivery of health and support services described in section 300ff−14 of this title that − (i) includes a strategy for identifying individuals who know their HIV status and are not receiving such services and for informing the individuals of and enabling the individuals to utilize the services, giving particular attention to eliminating disparities in access and services among affected subpopulations and historically underserved communities, and
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including discrete goals, a timetable, and an appropriate allocation of funds; (ii) includes a strategy to coordinate the provision of such services with programs for HIV prevention (including outreach and early intervention) and for the prevention and treatment of substance abuse (including programs that provide comprehensive treatment services for such abuse); and (iii) is compatible with any State or local plan for the provision of services to individuals with HIV disease; (E) assess the efficiency of the administrative mechanism in rapidly allocating funds to the areas of greatest need within the eligible area, and at the discretion of the planning council, assess the effectiveness, either directly or through contractual arrangements, of the services offered in meeting the identified needs; (F) participate in the development of the statewide coordinated statement of need initiated by the State public health agency responsible for administering grants under part B of this subchapter; (G) establish methods for obtaining input on community needs and priorities which may include public meetings (in accordance with paragraph (7)), conducting focus groups, and convening ad−hoc panels; and (H) coordinate with Federal grantees that provide HIV−related services within the eligible area. (5) Conflicts of interest
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(A) In general The planning council under paragraph (1) may not be directly involved in the administration of a grant under section 300ff−11(a) of this title. With respect to compliance with the preceding sentence, the planning council may not designate (or otherwise be involved in the selection of) particular entities as recipients of any of the amounts provided in the grant. (B) Required agreements An individual may serve on the planning council under paragraph (1) only if the individual agrees that if the individual has a financial interest in an entity, if the individual is an employee of a public or private entity, or if the individual is a member of a public or private organization, and such entity or organization is seeking amounts from a grant under section 300ff−11(a) of this title, the individual will not, with respect to the purpose for which the entity seeks such amounts, participate (directly or in an advisory capacity) in the process of selecting entities to receive such amounts for such purpose. (C) Composition of council The following applies regarding the membership of a planning council under paragraph (1): (i) Not less than 33 percent of the council shall be individuals who are receiving HIV−related services pursuant to a grant under section 300ff−11(a) of this title, are not officers, employees, or consultants to any entity that
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receives amounts from such a grant, and do not represent any such entity, and reflect the demographics of the population of individuals with HIV disease as determined under paragraph (4)(A). For purposes of the preceding sentence, an individual shall be considered to be receiving such services if the individual is a parent of, or a caregiver for, a minor child who is receiving such services. (ii) With respect to membership on the planning council, clause (i) may not be construed as having any effect on entities that receive funds from grants under any of parts B through F of this subchapter but do not receive funds from grants under section 300ff−11(a) of this title, on officers or employees of such entities, or on individuals who represent such entities. (6) Grievance procedures A planning council under paragraph (1) shall develop procedures for addressing grievances with respect to funding under this part, including procedures for submitting grievances that cannot be resolved to binding arbitration. Such procedures shall be described in the by−laws of the planning council and be consistent with the requirements of subsection (c) of this section. (7) Public deliberations With respect to a planning council under paragraph (1), the following applies: (A) The council may not be chaired solely by an employee of
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the grantee under section 300ff−11(a) of this title. (B) In accordance with criteria established by the Secretary: (i) The meetings of the council shall be open to the public and shall be held only after adequate notice to the public. (ii) The records, reports, transcripts, minutes, agenda, or other documents which were made available to or prepared for or by the council shall be available for public inspection and copying at a single location. (iii) Detailed minutes of each meeting of the council shall be kept. The accuracy of all minutes shall be certified to by the chair of the council. (iv) This subparagraph does not apply to any disclosure of information of a personal nature that would constitute a clearly unwarranted invasion of personal privacy, including any disclosure of medical information or personnel matters. (c) Grievance procedures (1) Federal responsibility (A) Models The Secretary shall, through a process that includes consultations with grantees under this part and public and private experts in grievance procedures, arbitration, and mediation, develop model grievance procedures that may be implemented by the planning council under subsection (b)(1) of this section and grantees under this part. Such model procedures shall describe the elements that must be addressed in establishing local grievance procedures and provide grantees
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with flexibility in the design of such local procedures. (B) Review The Secretary shall review grievance procedures established by the planning council and grantees under this part to determine if such procedures are adequate. In making such a determination, the Secretary shall assess whether such procedures permit legitimate grievances to be filed, evaluated, and resolved at the local level. (2) Grantees To be eligible to receive funds under this part, a grantee shall develop grievance procedures that are determined by the Secretary to be consistent with the model procedures developed under paragraph (1)(A). Such procedures shall include a process for submitting grievances to binding arbitration. (d) Process for establishing allocation priorities Promptly after the date of the submission of the report required in section 501(b) of the Ryan White CARE Act Amendments of 2000 (relating to the relationship between epidemiological measures and health care for certain individuals with HIV disease), the Secretary, in consultation with planning councils and entities that receive amounts from grants under section 300ff−11(a) or 300ff−21 of this title, shall develop epidemiologic measures − (1) for establishing the number of individuals living with HIV disease who are not receiving HIV−related health services; and (2) for carrying out the duties under subsection (b)(4) of this section and section 300ff−27(b) of this title.
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(e) Training guidance and materials The Secretary shall provide to each chief elected official receiving a grant under section 300ff−11(a) of this title guidelines and materials for training members of the planning council under paragraph (1) regarding the duties of the council. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2602, as added Pub. L. 101−381, title I, Sec. 101(3), Aug. 18, 1990, 104 Stat. 577; amended Pub. L. 102−531, title III, Sec. 312(d)(26), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 104−146, Sec. 3(b)(1), May 20, 1996, 110 Stat. 1347; Pub. L. 106−345, title I, Secs. 101−102(c), 103, Oct. 20, 2000, 114 Stat. 1320−1323.) −REFTEXT− REFERENCES IN TEXT Subpart II of part C of this subchapter, referred to in subsec. (b)(2)(J), was redesignated subpart I of part C of this subchapter by Pub. L. 106−345, title III, Sec. 301(b)(1), Oct. 20, 2000, 114 Stat. 1345, and is classified to section 300ff−51 et seq. of this title. The Social Security Act, referred to in subsec. (b)(4)(C)(v), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles XIX and XXI of the Act are classified generally to subchapters XIX (Sec. 1396 et seq.) and XXI (Sec. 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. Section 501 of the Ryan White CARE Act Amendments of 2000,
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referred to in subsec. (d), is section 501 of Pub. L. 106−345, which is set out as a note under section 300ff−11 of this title. Provisions relating to a report are contained in section 501(d) of Pub. L. 106−345. −MISC1− PRIOR PROVISIONS A prior section 2602 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238a of this title. AMENDMENTS 2000 − Subsec. (b)(1). Pub. L. 106−345, Sec. 101(a)(1), substituted "demographics of the population of individuals with HIV disease in the eligible area involved," for "demographics of the epidemic in the eligible area involved,". Subsec. (b)(2)(C). Pub. L. 106−345, Sec. 101(a)(2)(A), inserted before semicolon at end ", including providers of housing and homeless services". Subsec. (b)(2)(G). Pub. L. 106−345, Sec. 101(a)(2)(B), struck out "or AIDS" after "HIV disease". Subsec. (b)(2)(K). Pub. L. 106−345, Sec. 101(a)(2)(C), struck out "and" after semicolon. Subsec. (b)(2)(L). Pub. L. 106−345, Sec. 101(a)(2)(D), substituted ", including but not limited to providers of HIV prevention services; and" for period at end. Subsec. (b)(2)(M). Pub. L. 106−345, Sec. 101(a)(2)(E), added subpar. (M).
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Subsec. (b)(3)(C). Pub. L. 106−345, Sec. 103(1), struck out heading and text of subpar. (C). Text read as follows: "A planning council may not be chaired solely by an employee of the grantee." Subsec. (b)(4)(A), (B). Pub. L. 106−345, Sec. 102(a)(2), added subpars. (A) and (B). Former subpars. (A) and (B) redesignated (C) and (D), respectively. Subsec. (b)(4)(C). Pub. L. 106−345, Sec. 102(a)(1), redesignated subpar. (A) as (C). Former subpar. (C) redesignated (E). Subsec. (b)(4)(C)(i) to (vi). Pub. L. 106−345, Sec. 102(a)(3), added cls. (i) to (vi) and struck out former cls. (i) to (iv) which read as follows: "(i) documented needs of the HIV−infected population; "(ii) cost and outcome effectiveness of proposed strategies and interventions, to the extent that such data are reasonably available (either demonstrated or probable); "(iii) priorities of the HIV−infected communities for whom the services are intended; and "(iv) availability of other governmental and nongovernmental resources;". Subsec. (b)(4)(D). Pub. L. 106−345, Sec. 102(a)(4), amended subpar. (D) generally. Prior to amendment, subpar. (D) read as follows: "develop a comprehensive plan for the organization and delivery of health services described in section 300ff−14 of this title that is compatible with any existing State or local plan regarding the provision of health services to individuals with HIV disease;".
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Pub. L. 106−345, Sec. 102(a)(1), redesignated subpar. (B) as (D). Former subpar. (D) redesignated (F). Subsec. (b)(4)(E), (F). Pub. L. 106−345, Sec. 102(a)(1), redesignated subpars. (C) and (D) as (E) and (F), respectively. Former subpar. (E) redesignated (G). Subsec. (b)(4)(G). Pub. L. 106−345, Sec. 102(a)(1), (6)(A), redesignated subpar. (E) as (G) and substituted "public meetings (in accordance with paragraph (7))," for "public meetings,". Subsec. (b)(4)(H). Pub. L. 106−345, Sec. 102(a)(5), (6)(B), (7), added subpar. (H). Subsec. (b)(5)(C). Pub. L. 106−345, Sec. 101(b), added subpar. (C). Subsec. (b)(7). Pub. L. 106−345, Sec. 103(2), added par. (7). Subsec. (d). Pub. L. 106−345, Sec. 102(b), added subsec. (d). Subsec. (e). Pub. L. 106−345, Sec. 102(c), added subsec. (e). 1996 − Subsec. (b)(1). Pub. L. 104−146, Sec. 3(b)(1)(A)(ii), inserted at end "Nominations for membership on the council shall be identified through an open process and candidates shall be selected based on locally delineated and publicized criteria. Such criteria shall include a conflict−of−interest standard that is in accordance with paragraph (5)." Pub. L. 104−146, Sec. 3(b)(1)(A)(i), substituted "reflect in its composition the demographics of the epidemic in the eligible area involved, with particular consideration given to disproportionately affected and historically underserved groups and subpopulations." for "include representatives of −
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"(A) health care providers; "(B) community−based and AIDS service organizations; "(C) social service providers; "(D) mental health care providers; "(E) local public health agencies; "(F) hospital planning agencies or health care planning agencies; "(G) affected communities, including individuals with HIV disease; "(H) non−elected community leaders; "(I) State government; "(J) grantees under subpart II of part C of this subchapter; and "(K) the lead agency of any Health Resources and Services Administration adult and pediatric HIV−related care demonstration project operating in the area to be served." Subsec. (b)(2). Pub. L. 104−146, Sec. 3(b)(1)(E), added par. (2). Former par. (2) redesignated (3). Subsec. (b)(2)(C). Pub. L. 104−146, Sec. 3(b)(1)(B), added subpar. (C). Subsec. (b)(3). Pub. L. 104−146, Sec. 3(b)(1)(D), redesignated par. (2) as (3). Former par. (3) redesignated (4). Subsec. (b)(3)(A). Pub. L. 104−146, Sec. 3(b)(1)(C)(i), substituted "area, including how best to meet each such priority and additional factors that a grantee should consider in allocating funds under a grant based on the − " for "area;" and added cls. (i)
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to (iv). Subsec. (b)(3)(B). Pub. L. 104−146, Sec. 3(b)(1)(C)(ii), struck out "and" at end. Subsec. (b)(3)(C). Pub. L. 104−146, Sec. 3(b)(1)(C)(iii), substituted ", and at the discretion of the planning council, assess the effectiveness, either directly or through contractual arrangements, of the services offered in meeting the identified needs;" for period at end. Subsec. (b)(3)(D), (E). Pub. L. 104−146, Sec. 3(b)(1)(C)(iv), added subpars. (D) and (E). Subsec. (b)(4). Pub. L. 104−146, Sec. 3(b)(1)(D), redesignated par. (3) as (4). Subsec. (b)(5), (6). Pub. L. 104−146, Sec. 3(b)(1)(F), added pars. (5) and (6). Subsec. (c). Pub. L. 104−146, Sec. 3(b)(1)(F), added subsec. (c). 1992 − Subsec. (a)(1). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106−345, title VI, Sec. 601, Oct. 20, 2000, 114 Stat. 1355, provided that: "This Act [see section 1 of Pub. L. 106−345, set out as a Short Title of 2000 Amendments note under section 201 of this title] and the amendments made by this Act take effect October 1, 2000, or upon the date of the enactment of this Act [Oct. 20, 2000], whichever occurs later." EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section
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13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−13, 300ff−14, 300ff−15, 300ff−23, 300ff−27 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−13 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−13. Type and distribution of grants −STATUTE− (a) Grants based on relative need of area (1) In general In carrying out section 300ff−11(a) of this title, the Secretary shall make a grant for each eligible area for which an application under section 300ff−15(a) of this title has been approved. Each such grant shall be made in an amount determined
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in accordance with paragraph (3). (2) Expedited distribution Not later than 60 days after an appropriation becomes available to carry out this part for a fiscal year, the Secretary shall, except in the case of waivers granted under section 300ff−15(c) (!1) of this title, disburse 50 percent of the amount appropriated under section 300ff−77 of this title for such fiscal year through grants to eligible areas under section 300ff−11(a) of this title, in accordance with paragraph (3). The Secretary shall reserve an additional percentage of the amount appropriated under section 300ff−77 of this title for a fiscal year for grants under this part to make grants to eligible areas under section 300ff−11(a) of this title in accordance with paragraph (4). (3) Amount of grant (A) In general Subject to the extent of amounts made available in appropriations Acts, a grant made for purposes of this paragraph to an eligible area shall be made in an amount equal to the product of − (i) an amount equal to the amount available for distribution under paragraph (2) for the fiscal year involved; and (ii) the percentage constituted by the ratio of the distribution factor for the eligible area to the sum of the respective distribution factors for all eligible areas. (B) Distribution factor
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For purposes of subparagraph (A)(ii), the term "distribution factor" means an amount equal to the estimated number of living cases of acquired immune deficiency syndrome in the eligible area involved, as determined under subparagraph (C). (C) Estimate of living cases The amount determined in this subparagraph is an amount equal to the product of − (i) the number of cases of acquired immune deficiency syndrome in the eligible area during each year in the most recent 120−month period for which data are available with respect to all eligible areas, as indicated by the number of such cases reported to and confirmed by the Director of the Centers for Disease Control and Prevention for each year during such period, except that (subject to subparagraph (D)), for grants made pursuant to this paragraph for fiscal year 2005 and subsequent fiscal years, the cases counted for each 12−month period beginning on or after July 1, 2004, shall be cases of HIV disease (as reported to and confirmed by such Director) rather than cases of acquired immune deficiency syndrome; and (ii) with respect to − (I) the first year during such period, .06; (II) the second year during such period, .06; (III) the third year during such period, .08; (IV) the fourth year during such period, .10; (V) the fifth year during such period, .16;
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(VI) the sixth year during such period, .16; (VII) the seventh year during such period, .24; (VIII) the eighth year during such period, .40; (IX) the ninth year during such period, .57; and (X) the tenth year during such period, .88. The yearly percentage described in subparagraph (ii) shall be updated biennially by the Secretary, after consultation with the Centers for Disease Control and Prevention, and shall be reported to the congressional committees of jurisdiction. The first such update shall occur prior to the determination of grant awards under this part for fiscal year 1998. Updates shall as applicable take into account the counting of cases of HIV disease pursuant to clause (i). (D) Determination of Secretary regarding data on HIV cases (i) In general Not later than July 1, 2004, the Secretary shall determine whether there is data on cases of HIV disease from all eligible areas (reported to and confirmed by the Director of the Centers for Disease Control and Prevention) sufficiently accurate and reliable for use for purposes of subparagraph (C)(i). In making such a determination, the Secretary shall take into consideration the findings of the study under section 501(b) of the Ryan White CARE Act Amendments of 2000 (relating to the relationship between epidemiological measures and health care for certain individuals with HIV disease).
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(ii) Effect of adverse determination If under clause (i) the Secretary determines that data on cases of HIV disease is not sufficiently accurate and reliable for use for purposes of subparagraph (C)(i), then notwithstanding such subparagraph, for any fiscal year prior to fiscal year 2007 the references in such subparagraph to cases of HIV disease do not have any legal effect. (iii) Grants and technical assistance regarding counting of HIV cases Of the amounts appropriated under section 247c−2 of this title for a fiscal year, the Secretary shall reserve amounts to make grants and provide technical assistance to States and eligible areas with respect to obtaining data on cases of HIV disease to ensure that data on such cases is available from all States and eligible areas as soon as is practicable but not later than the beginning of fiscal year 2007. (E) Unexpended funds The Secretary may, in determining the amount of a grant for a fiscal year under this paragraph, adjust the grant amount to reflect the amount of unexpended and uncanceled grant funds remaining at the end of the fiscal year preceding the year for which the grant determination is to be made. The amount of any such unexpended funds shall be determined using the financial status report of the grantee. (4) Increases in grant (A) In general
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For each fiscal year in a protection period for an eligible area, the Secretary shall increase the amount of the grant made pursuant to paragraph (2) for the area to ensure that − (i) for the first fiscal year in the protection period, the grant is not less than 98 percent of the amount of the grant made for the eligible area pursuant to such paragraph for the base year for the protection period; (ii) for any second fiscal year in such period, the grant is not less than 95 percent of the amount of such base year grant; (iii) for any third fiscal year in such period, the grant is not less than 92 percent of the amount of the base year grant; (iv) for any fourth fiscal year in such period, the grant is not less than 89 percent of the amount of the base year grant; and (v) for any fifth or subsequent fiscal year in such period, if, pursuant to paragraph (3)(D)(ii), the references in paragraph (3)(C)(i) to HIV disease do not have any legal effect, the grant is not less than 85 percent of the amount of the base year grant. (B) Special rule If for fiscal year 2005, pursuant to paragraph (3)(D)(ii), data on cases of HIV disease are used for purposes of paragraph (3)(C)(i), the Secretary shall increase the amount of a grant made pursuant to paragraph (2) for an eligible area to ensure
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that the grant is not less than 98 percent of the amount of the grant made for the area in fiscal year 2004. (C) Base year; protection period With respect to grants made pursuant to paragraph (2) for an eligible area: (i) The base year for a protection period is the fiscal year preceding the trigger grant−reduction year. (ii) The first trigger grant−reduction year is the first fiscal year (after fiscal year 2000) for which the grant for the area is less than the grant for the area for the preceding fiscal year. (iii) A protection period begins with the trigger grant−reduction year and continues until the beginning of the first fiscal year for which the amount of the grant determined pursuant to paragraph (2) for the area equals or exceeds the amount of the grant determined under subparagraph (A). (iv) Any subsequent trigger grant−reduction year is the first fiscal year, after the end of the preceding protection period, for which the amount of the grant is less than the amount of the grant for the preceding fiscal year. (b) Supplemental grants (1) In general Not later than 150 days after the date on which appropriations are made under section 300ff−77 of this title for a fiscal year, the Secretary shall disburse the remainder of amounts not
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disbursed under subsection (a)(2) of this section for such fiscal year for the purpose of making grants under section 300ff−11(a) of this title to eligible areas whose application under section 300ff−15(b) of this title − (A) contains a report concerning the dissemination of emergency relief funds under subsection (a) of this section and the plan for utilization of such funds; (B) demonstrates the severe need in such area for supplemental financial assistance to combat the HIV epidemic; (C) demonstrates the existing commitment of local resources of the area, both financial and in−kind, to combating the HIV epidemic; (D) demonstrates the ability of the area to utilize such supplemental financial resources in a manner that is immediately responsive and cost effective; (E) demonstrates that resources will be allocated in accordance with the local demographic incidence of AIDS including appropriate allocations for services for infants, children, youth, women, and families with HIV disease; (F) demonstrates the inclusiveness of the planning council membership, with particular emphasis on affected communities and individuals with HIV disease; and (G) demonstrates the manner in which the proposed services are consistent with the local needs assessment and the statewide coordinated statement of need. (2) Amount of grant
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(A) In general The amount of each grant made for purposes of this subsection shall be determined by the Secretary based on a weighting of factors under paragraph (1), with severe need under subparagraph (B) of such paragraph counting one−third. (B) Severe need In determining severe need in accordance with paragraph (1)(B), the Secretary shall consider the ability of the qualified applicant to expend funds efficiently and the impact of relevant factors on the cost and complexity of delivering health care and support services to individuals with HIV disease in the eligible area, including factors such as − (i) sexually transmitted diseases, substance abuse, tuberculosis, severe mental illness, or other comorbid factors determined relevant by the Secretary; (ii) new or growing subpopulations of individuals with HIV disease; (iii) homelessness; (iv) the current prevalence of HIV disease; (v) an increasing need for HIV−related services, including relative rates of increase in the number of cases of HIV disease; and (vi) unmet need for such services, as determined under section 300ff−12(b)(4) of this title. (C) Prevalence In determining the impact of the factors described in
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subparagraph (B), the Secretary shall, to the extent practicable, use national, quantitative incidence data that are available for each eligible area. Not later than 18 months after October 20, 2000, the Secretary shall develop a mechanism to utilize such data. Such a mechanism shall be modified to reflect the findings of the study under section 501(b) of the Ryan White CARE Act Amendments of 2000 (relating to the relationship between epidemiological measures and health care for certain individuals with HIV disease). In the absence of such data, the Secretary may consider a detailed description and qualitative analysis of severe need, as determined under subparagraph (B), including any local prevalence data gathered and analyzed by the eligible area. (D) Priority Subsequent to the development of the quantitative mechanism described in subparagraph (C), the Secretary shall phase in, over a 3−year period beginning in fiscal year 1998, the use of such a mechanism to determine the severe need of an eligible area compared to other eligible areas and to determine, in part, the amount of supplemental funds awarded to the eligible area under this part. (3) Remainder of amounts In determining the amount of funds to be obligated under paragraph (1), the Secretary shall include amounts that are not paid to the eligible areas under expedited procedures under subsection (a)(2) of this section as a result of −
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(A) the failure of any eligible area to submit an application under section 300ff−15(c) (!2) of this title; or (B) any eligible area informing the Secretary that such eligible area does not intend to expend the full amount of its grant under such section. (4) Failure to submit (A) In general The failure of an eligible area to submit an application for an expedited grant under subsection (a)(2) of this section shall not result in such area being ineligible for a grant under this subsection. (B) Application The application of an eligible area submitted under section 300ff−15(b) of this title shall contain the assurances required under subsection (a) of such section if such eligible area fails to submit an application for an expedited grant under subsection (a)(2) of this section. (c) Compliance with priorities of HIV planning council Notwithstanding any other provision of this part, the Secretary, in carrying out section 300ff−11(a) of this title, may not make any grant under subsection (a) or (b) of this section to an eligible area unless the application submitted by such area under section 300ff−15 of this title for the grant involved demonstrates that the grants made under subsections (a) and (b) of this section to the area for the preceding fiscal year (if any) were expended in accordance with the priorities applicable to such year that were
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established, pursuant to section 300ff−12(b)(4)(C) of this title, by the planning council serving the area. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2603, as added Pub. L. 101−381, title I, Sec. 101(3), Aug. 18, 1990, 104 Stat. 578; amended Pub. L. 101−502, Sec. 6(a), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 102−531, title III, Sec. 312(d)(27), Oct. 27, 1992, 106 Stat. 3506; Pub. L. 104−146, Secs. 3(b)(2), (3), 4, 6(c)(1), 12(c)(2), May 20, 1996, 110 Stat. 1349, 1350, 1364, 1367, 1373; Pub. L. 106−345, title I, Secs. 102(d), 111, 112, Oct. 20, 2000, 114 Stat. 1323, 1326.) −REFTEXT− REFERENCES IN TEXT Section 300ff−15 of this title, referred to in subsecs. (a)(2) and (b)(3)(A), was amended by Pub. L. 104−146, Sec. 3(b)(5)(C), (D), May 20, 1996, 110 Stat. 1353, to add a new subsec. (c), relating to single application and grant awards, and redesignate former subsec. (c), relating to date for submission of grant applications, as (d). Section 501(b) of the Ryan White CARE Act Amendments of 2000, referred to in subsecs. (a)(3)(D)(i) and (b)(2)(C), is section 501(b) of Pub. L. 106−345, which is set out in a note under section 300ff−11 of this title. −MISC1− PRIOR PROVISIONS A prior section 2603 of act July 1, 1944, was successively
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renumbered by subsequent acts and transferred, see section 238b of this title. AMENDMENTS 2000 − Subsec. (a)(2). Pub. L. 106−345, Sec. 111(a), substituted "for a fiscal year" for "for each of the fiscal years 1996 through 2000" in first sentence. Subsec. (a)(3)(C)(i). Pub. L. 106−345, Sec. 111(b)(1)(A), inserted before semicolon ", except that (subject to subparagraph (D)), for grants made pursuant to this paragraph for fiscal year 2005 and subsequent fiscal years, the cases counted for each 12−month period beginning on or after July 1, 2004, shall be cases of HIV disease (as reported to and confirmed by such Director) rather than cases of acquired immune deficiency syndrome". Subsec. (a)(3)(C). Pub. L. 106−345, Sec. 111(b)(1)(B), in concluding provisions, inserted before period at end of first sentence ", and shall be reported to the congressional committees of jurisdiction" and inserted at end "Updates shall as applicable take into account the counting of cases of HIV disease pursuant to clause (i)." Subsec. (a)(3)(D), (E). Pub. L. 106−345, Sec. 111(b)(2), added subpar. (D) and redesignated former subpar. (D) as (E). Subsec. (a)(4). Pub. L. 106−345, Sec. 111(c), amended heading and text of par. (4) generally. Prior to amendment, text read as follows: "With respect to an eligible area under section 300ff−11(a) of this title, the Secretary shall increase the amount of a grant under paragraph (2) for a fiscal year to ensure that
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such eligible area receives not less than − "(A) with respect to fiscal year 1996, 100 percent; "(B) with respect to fiscal year 1997, 99 percent; "(C) with respect to fiscal year 1998, 98 percent; "(D) with respect to fiscal year 1999, 96.5 percent; and "(E) with respect to fiscal year 2000, 95 percent; of the amount allocated for fiscal year 1995 to such entity under this subsection." Subsec. (b)(1)(E). Pub. L. 106−345, Sec. 112(b), inserted "youth," after "children,". Subsec. (b)(2). Pub. L. 106−345, Sec. 112(a)(1), substituted "Amount of grant" for "Definition" in heading. Subsec. (b)(2)(A). Pub. L. 106−345, Sec. 112(a)(3), added subpar. (A). Former subpar. (A) redesignated (B). Subsec. (b)(2)(B). Pub. L. 106−345, Sec. 112(a)(2), (4), redesignated subpar. (A) as (B) and added cls. (iv) to (vi). Former subpar. (B) redesignated (C). Subsec. (b)(2)(C). Pub. L. 106−345, Sec. 112(a)(5)(C), inserted after second sentence "Such a mechanism shall be modified to reflect the findings of the study under section 501(b) of the Ryan White CARE Act Amendments of 2000 (relating to the relationship between epidemiological measures and health care for certain individuals with HIV disease)." Pub. L. 106−345, Sec. 112(a)(5)(B), in second sentence, substituted "18 months after October 20, 2000" for "2 years after May 20, 1996".
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Pub. L. 106−345, Sec. 112(a)(5)(A), substituted "subparagraph (B)" for "subparagraph (A)" in two places. Pub. L. 106−345, Sec. 112(a)(2), redesignated subpar. (B) as (C). Former subpar. (C) redesignated (D). Subsec. (b)(2)(D). Pub. L. 106−345, Sec. 112(a)(2), (6), redesignated subpar. (C) as (D) and substituted "subparagraph (C)" for "subparagraph (B)". Subsec. (b)(4). Pub. L. 106−345, Sec. 112(c)(1), (2), redesignated par. (5) as (4) and struck out heading and text of former par. (4). Text read as follows: "The amount of each grant made for purposes of this subsection shall be determined by the Secretary based on the application submitted by the eligible area under section 300ff−15(b) of this title." Subsec. (b)(4)(B). Pub. L. 106−345, Sec. 112(c)(3), substituted "an expedited grant" for "an expedited grants". Subsec. (b)(5). Pub. L. 106−345, Sec. 112(c)(2), redesignated par. (5) as (4). Subsec. (c). Pub. L. 106−345, Sec. 102(d), substituted "section 300ff−12(b)(4)(C) of this title" for "section 300ff−12(b)(3)(A) of this title". 1996 − Subsec. (a)(2). Pub. L. 104−146, Sec. 6(c)(1)(A), substituted "section 300ff−77" for "section 300ff−18". Pub. L. 104−146, Sec. 3(b)(3)(A), inserted ", in accordance with paragraph (3)" after "section 300ff−11(a) of this title" and "The Secretary shall reserve an additional percentage of the amount appropriated under section 300ff−77 of this title for a fiscal year
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for grants under this part to make grants to eligible areas under section 300ff−11(a) of this title in accordance with paragraph (4)." at end. Pub. L. 104−146, Sec. 3(b)(2)(A), substituted "Not later than 60 days after an appropriation becomes available to carry out this part for each of the fiscal years 1996 through 2000, the Secretary shall" for "Not later than − "(A) 90 days after an appropriation becomes available to carry out this part for fiscal year 1991; and "(B) 60 days after an appropriation becomes available to carry out this part for each of fiscal years 1992 through 1995; the Secretary shall". Subsec. (a)(3). Pub. L. 104−146, Sec. 4, amended par. (3) generally, revising and restating provisions of former subpars. (A) to (C) relating to amount of grants under par. (3) as subpars. (A) to (D). Subsec. (a)(4). Pub. L. 104−146, Sec. 3(b)(3)(B), added par. (4). Subsec. (b)(1). Pub. L. 104−146, Sec. 6(c)(1)(B), substituted "section 300ff−77" for "section 300ff−18" in introductory provisions. Subsec. (b)(1)(F), (G). Pub. L. 104−146, Sec. 3(b)(2)(B)(i), added subpars. (F) and (G). Subsec. (b)(2) to (4). Pub. L. 104−146, Sec. 3(b)(2)(B)(ii), (iii), added par. (2) and redesignated former pars. (2) and (3) as (3) and (4), respectively. Former par. (4) redesignated (5). Subsec. (b)(4)(B). Pub. L. 104−146, Sec. 12(c)(2), which directed
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substitution of "an expedited grant" for "an expedited grants" in par. (4)(B), could not be executed because the words "an expedited grants" did not appear in par. (4)(B) subsequent to redesignation of par. (4) as (5) by Pub. L. 104−146, Sec. 3(b)(2)(B)(ii). See above. Subsec. (b)(5). Pub. L. 104−146, Sec. 3(b)(2)(B)(ii), redesignated par. (4) as (5). Subsec. (c). Pub. L. 104−146, Sec. 3(b)(3)(C), added subsec. (c). 1992 − Subsec. (a)(3)(B)(i). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". 1990 − Subsec. (a)(3). Pub. L. 101−502 amended par. (3) generally. Prior to amendment, par. (3) read as follows: "(A) In general. − Subject to the extent of amounts made available in appropriations Acts, a grant made for purposes of this paragraph for an eligible area shall be made in an amount equal to the sum of − "(i) an amount determined in accordance with subparagraph (B); and "(ii) an amount determined in accordance with subparagraph (C). "(B) Amount relating to cumulative number of cases. − The amount referred to in clause (i) of subparagraph (A) is an amount equal to the product of − "(i) an amount equal to 75 percent of the amounts available for distribution under paragraph (2) for the fiscal year involved; and
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"(ii) a percentage equal to the quotient of − "(I) the cumulative number of cases of acquired immune deficiency syndrome in the eligible area involved, as indicated by the number of such cases reported to and confirmed by the Director of the Centers for Disease Control on the applicable date described in section 300ff−11(a) of this title; divided by "(II) the sum of the cumulative number of such cases in all eligible areas for which an application for a grant under paragraph (1) has been approved. "(C) Amount relating to per capita incidence of cases. − The amount referred to in clause (ii) of subparagraph (A) is an amount equal to the product of − "(i) an amount equal to 25 percent of the amounts available for distribution under paragraph (2) for the fiscal year involved; and "(ii) a percentage developed by the Secretary through consideration of the ratio of − "(I) the per capita incidence of cumulative cases of acquired immune deficiency syndrome in the eligible area involved (computed on the basis of the most recently available data on the population of the area); to "(II) the per capita incidence of such cumulative cases in all eligible areas for which an application for a grant under paragraph (1) has been approved (computed on the basis of the most recently available data on the population of such areas)." EFFECTIVE DATE OF 1996 AMENDMENT
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Amendment by sections 3(b)(2), (3), 4, 6(c)(1)(B), and 12(c)(2) of Pub. L. 104−146 effective Oct. 1, 1996, and amendment by section 6(c)(1)(A) of Pub. L. 104−146 effective May 20, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−11, 300ff−15, 300ff−28 of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−14 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−14. Use of amounts −STATUTE− (a) Requirements The Secretary may not make a grant under section 300ff−11(a) of
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this title to the chief elected official of an eligible area unless such political subdivision agrees that − (1) subject to paragraph (2), the allocation of funds and services within the eligible area will be made in accordance with the priorities established, pursuant to section 300ff−12(b)(3)(A) (!1) of this title, by the HIV health services planning council that serves such eligible area; and (2) funds provided under section 300ff−11 of this title will be expended only for the purposes described in subsections (b) and (c) (!1) of this section. (b) Primary purposes (1) In general The chief elected official shall use amounts received under a grant under section 300ff−11 of this title to provide direct financial assistance to entities described in paragraph (2) for the purpose of delivering or enhancing HIV−related services, as follows: (A) Outpatient and ambulatory health services, including substance abuse treatment, mental health treatment, and comprehensive treatment services, which shall include treatment education and prophylactic treatment for opportunistic infections, for individuals and families with HIV disease. (B) Outpatient and ambulatory support services (including case management), to the extent that such services facilitate, enhance, support, or sustain the delivery, continuity, or benefits of health services for individuals and families with
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HIV disease. (C) Inpatient case management services that prevent unnecessary hospitalization or that expedite discharge, as medically appropriate, from inpatient facilities. (D) Outreach activities that are intended to identify individuals with HIV disease who know their HIV status and are not receiving HIV−related services, and that are − (i) necessary to implement the strategy under section 300ff−12(b)(4)(D) of this title, including activities facilitating the access of such individuals to HIV−related primary care services at entities described in paragraph (3)(A); (ii) conducted in a manner consistent with the requirements under sections 300ff−15(a)(3) and 300ff−51(b)(2) of this title; and (iii) supplement, and do not supplant, such activities that are carried out with amounts appropriated under section 247b of this title. (2) Appropriate entities (A) In general Subject to subparagraph (B), direct financial assistance may be provided under paragraph (1) to public or nonprofit private entities,,(!2) or private for−profit entities if such entities are the only available provider of quality HIV care in the area, including hospitals (which may include Department of Veterans Affairs facilities), community−based organizations,
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hospices, ambulatory care facilities, community health centers, migrant health centers, homeless health centers, substance abuse treatment programs, and mental health programs. (B) Priority In providing direct financial assistance under paragraph (1) the chief elected official shall give priority to entities that are currently participating in Health Resources and Services Administration HIV health care demonstration projects. (3) Early intervention services (A) In general The purposes for which a grant under section 300ff−11 of this title may be used include providing to individuals with HIV disease early intervention services described in section 300ff−51(b)(2) of this title, with follow−up referral provided for the purpose of facilitating the access of individuals receiving the services to HIV−related health services. The entities through which such services may be provided under the grant include public health departments, emergency rooms, substance abuse and mental health treatment programs, detoxification centers, detention facilities, clinics regarding sexually transmitted diseases, homeless shelters, HIV disease counseling and testing sites, health care points of entry specified by eligible areas, federally qualified health centers, and entities described in section 300ff−52(a) of this title that constitute a point of access to services by maintaining referral relationships.
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(B) Conditions With respect to an entity that proposes to provide early intervention services under subparagraph (A), such subparagraph applies only if the entity demonstrates to the satisfaction of the chief elected official for the eligible area involved that − (i) Federal, State, or local funds are otherwise inadequate for the early intervention services the entity proposes to provide; and (ii) the entity will expend funds pursuant to such subparagraph to supplement and not supplant other funds available to the entity for the provision of early intervention services for the fiscal year involved. (4) Priority for women, infants and children (A) In general For the purpose of providing health and support services to infants, children, youth, and women with HIV disease, including treatment measures to prevent the perinatal transmission of HIV, the chief elected official of an eligible area, in accordance with the established priorities of the planning council, shall for each of such populations in the eligible area use, from the grants made for the area under section 300ff−11(a) of this title for a fiscal year, not less than the percentage constituted by the ratio of the population involved (infants, children, youth, or women in such area) with acquired immune deficiency syndrome to the general population in such
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area of individuals with such syndrome. (B) Waiver With respect to the population involved, the Secretary may provide to the chief elected official of an eligible area a waiver of the requirement of subparagraph (A) if such official demonstrates to the satisfaction of the Secretary that the population is receiving HIV−related health services through the State medicaid program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], the State children's health insurance program under title XXI of such Act [42 U.S.C. 1397aa et seq.], or other Federal or State programs. (c) Quality management (1) Requirement The chief elected official of an eligible area that receives a grant under this part shall provide for the establishment of a quality management program to assess the extent to which HIV health services provided to patients under the grant are consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infection, and as applicable, to develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to and quality of HIV health services. (2) Use of funds From amounts received under a grant awarded under this part for a fiscal year, the chief elected official of an eligible area may (in addition to amounts to which subsection (f)(1) of this
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section applies) use for activities associated with the quality management program required in paragraph (1) not more than the lesser of − (A) 5 percent of amounts received under the grant; or (B) $3,000,000. (d) Limited expenditures for personnel needs (1) In general A chief elected official, in accordance with paragraph (3), may use not to exceed 10 percent of amounts received under a grant under section 300ff−11 of this title to provide financial assistance or services, for the purposes described in paragraph (2), to any public or nonprofit private entity, including hospitals (which may include Veterans Administration facilities), nursing homes, subacute and transitional care facilities, and hospices that − (A) provide HIV−related care or services to a disproportionate share of low−income individuals and families with HIV disease; (B) incur uncompensated costs in the provision of such care or services to such individuals and families; (C) have established, and agree to implement, a plan to evaluate the utilization of services provided in the care of individuals and families with HIV disease; and (D) have established a system designed to ensure that such individuals and families are referred to the most medically appropriate level of care as soon as such referral is medically
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indicated. (2) Use A chief elected official may use amounts referred to in paragraph (1) to − (A) provide direct financial assistance to institutions and entities of the type referred to in such paragraph to assist such institutions and entities in recruiting or training and paying compensation to qualified personnel determined, under paragraph (3), to be necessary by the HIV health services planning council, specifically for the care of individuals with HIV disease; or (B) in lieu of providing direct financial assistance, make arrangements for the provision of the services of such qualified personnel to such institutions and entities. (3) Requirement of determination by council A chief elected official shall not use any of the amounts received under a grant under section 300ff−11(a) of this title to provide assistance or services under paragraph (2) unless the HIV health services planning council of the eligible area has made a determination that, with respect to the care of individuals with HIV disease − (A) a shortage of specific health, mental health or support service personnel exists within specific institutions or entities in the eligible area; (B) the shortage of such personnel has resulted in the inappropriate utilization of inpatient services within the
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area; and (C) assistance or services provided to an institution or entity under paragraph (2), will not be used to supplant the existing resources devoted by such institution or entity to the uses described in such paragraph. (e) Requirement of status as medicaid provider (1) Provision of service Subject to paragraph (2), the Secretary may not make a grant under section 300ff−11(a) of this title for the provision of services under this section in a State unless, in the case of any such service that is available pursuant to the State plan approved under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for the State − (A) the political subdivision involved will provide the service directly, and the political subdivision has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or (B) the political subdivision will enter into an agreement with a public or nonprofit private entity under which the entity will provide the service, and the entity has entered into such a participation agreement and is qualified to receive such payments. (2) Waiver (A) In general In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the
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requirement established in such paragraph shall be waived by the HIV health services planning council for the eligible area if the entity does not, in providing health care services, impose a charge or accept reimbursement available from any third−party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program. (B) Determination A determination by the HIV health services planning council of whether an entity referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the entity accepts voluntary donations for the purpose of providing services to the public. (f) Administration (1) In general The chief executive officer of an eligible area shall not use in excess of 5 percent of amounts received under a grant awarded under this part for administration,.(!3) In the case of entities and subcontractors to which such officer allocates amounts received by the officer under the grant, the officer shall ensure that, of the aggregate amount so allocated, the total of the expenditures by such entities for administrative expenses does not exceed 10 percent (without regard to whether particular entities expend more than 10 percent for such expenses). (2) Administrative activities For the purposes of paragraph (1), amounts may be used for administrative activities that include −
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(A) routine grant administration and monitoring activities, including the development of applications for part A funds, the receipt and disbursal of program funds, the development and establishment of reimbursement and accounting systems, the preparation of routine programmatic and financial reports, and compliance with grant conditions and audit requirements; and (B) all activities associated with the grantee's contract award procedures, including the development of requests for proposals, contract proposal review activities, negotiation and awarding of contracts, monitoring of contracts through telephone consultation, written documentation or onsite visits, reporting on contracts, and funding reallocation activities. (3) Subcontractor administrative costs For the purposes of this subsection, subcontractor administrative activities include − (A) usual and recognized overhead, including established indirect rates for agencies; (B) management oversight of specific programs funded under this subchapter; and (C) other types of program support such as quality assurance, quality control, and related activities. (g) Construction A State may not use amounts received under a grant awarded under this part to purchase or improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or to make cash payments to intended recipients
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of services. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2604, as added Pub. L. 101−381, title I, Sec. 101(3), Aug. 18, 1990, 104 Stat. 580; amended Pub. L. 103−446, title XII, Sec. 1203(a)(3), Nov. 2, 1994, 108 Stat. 4689; Pub. L. 104−146, Sec. 3(b)(4), May 20, 1996, 110 Stat. 1351; Pub. L. 106−345, title I, Sec. 121, Oct. 20, 2000, 114 Stat. 1326.) −REFTEXT− REFERENCES IN TEXT Section 300ff−12(b) of this title, referred to in subsec. (a)(1), was amended by Pub. L. 104−146, Sec. 3(b)(1)(D), May 20, 1996, 110 Stat. 1348, to redesignate pars. (2) and (3) as (3) and (4), respectively. As so redesignated, par. (3)(A) relates to establishment or designation of councils and par. (4)(A) relates to establishment of priorities by planning councils. Subsection (c) of this section, referred to in subsec. (a)(2), was redesignated subsec. (d), and a new subsec. (c) was added, by Pub. L. 106−345, title I, Sec. 121(d), Oct. 20, 2000, 114 Stat. 1328. The Social Security Act, referred to in subsecs. (b)(4)(B) and (e)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles XIX and XXI of the Act are classified generally to subchapters XIX (Sec. 1396 et seq.) and XXI (Sec. 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this
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title and Tables. −MISC1− PRIOR PROVISIONS A prior section 2604 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238c of this title. AMENDMENTS 2000 − Subsec. (b)(1). Pub. L. 106−345, Sec. 121(a)(1), substituted "HIV−related services, as follows:" for "HIV−related − " in introductory provisions. Subsec. (b)(1)(A). Pub. L. 106−345, Sec. 121(a)(2), substituted "Outpatient and ambulatory health services, including substance abuse treatment," for "outpatient and ambulatory health and support services, including case management, substance abuse treatment and" and substituted a period for "; and" at end. Subsec. (b)(1)(B). Pub. L. 106−345, Sec. 121(a)(4), added subpar. (B). Former subpar. (B) redesignated (C). Subsec. (b)(1)(C). Pub. L. 106−345, Sec. 121(a)(3), redesignated subpar. (B) as (C) and substituted "Inpatient" for "inpatient". Subsec. (b)(1)(D). Pub. L. 106−345, Sec. 121(a)(5), added subpar. (D). Subsec. (b)(3). Pub. L. 106−345, Sec. 121(b)(2), added par. (3). Former par. (3) redesignated (4). Subsec. (b)(4). Pub. L. 106−345, Sec. 121(b)(1), (c), redesignated par. (3) as (4) and amended heading and text of par. (4) generally. Prior to amendment, text read as follows: "For the
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purpose of providing health and support services to infants, children, and women with HIV disease, including treatment measures to prevent the perinatal transmission of HIV, the chief elected official of an eligible area, in accordance with the established priorities of the planning council, shall use, from the grants made for the area under section 300ff−11(a) of this title for a fiscal year, not less than the percentage constituted by the ratio of the population in such area of infants, children, and women with acquired immune deficiency syndrome to the general population in such area of individuals with such syndrome." Subsecs. (c) to (g). Pub. L. 106−345, Sec. 121(d), added subsec. (c) and redesignated former subsecs. (c) to (f) as (d) to (g), respectively. 1996 − Subsec. (b)(1)(A). Pub. L. 104−146, Sec. 3(b)(4)(A), inserted ", substance abuse treatment and mental health treatment," after "case management" and "which shall include treatment education and prophylactic treatment for opportunistic infections," after "treatment services,". Subsec. (b)(2)(A). Pub. L. 104−146, Sec. 3(b)(4)(B), inserted ", or private for−profit entities if such entities are the only available provider of quality HIV care in the area," after "nonprofit private entities," and substituted "homeless health centers, substance abuse treatment programs, and mental health programs" for "and homeless health centers". Subsec. (b)(3). Pub. L. 104−146, Sec. 3(b)(4)(C), added par. (3). Subsec. (e). Pub. L. 104−146, Sec. 3(b)(4)(C), struck out "and
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planning" after "Administration" in heading, designated existing provisions as par. (1), inserted par. heading, struck out "accounting, reporting, and program oversight functions" after "for administration,", inserted at end "In the case of entities and subcontractors to which such officer allocates amounts received by the officer under the grant, the officer shall ensure that, of the aggregate amount so allocated, the total of the expenditures by such entities for administrative expenses does not exceed 10 percent (without regard to whether particular entities expend more than 10 percent for such expenses).", and added pars. (2) and (3). 1994 − Subsec. (b)(2)(A). Pub. L. 103−446 substituted "Department of Veterans Affairs facilities" for "Veterans Administration facilities". −CHANGE− CHANGE OF NAME Reference to Veterans Administration deemed to refer to Department of Veterans Affairs pursuant to section 10 of Pub. L. 100−527, set out as a Department of Veterans Affairs Act note under section 301 of Title 38, Veterans' Benefits. −MISC2− EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING, OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
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Reference to community health center, migrant health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104−299, set out as a note under section 254b of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−11, 300ff−12, 300ff−15, 300ff−22 of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) So in original. (!3) So in original. The comma probably should not appear. −End− −CITE− 42 USC Sec. 300ff−15 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−15. Application −STATUTE− (a) In general To be eligible to receive a grant under section 300ff−11 of this
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title, an eligible area shall prepare and submit to the Secretary an application, in accordance with subsection (c) of this section regarding a single application and grant award, at such time, in such form, and containing such information as the Secretary shall require, including assurances adequate to ensure − (1)(A) that funds received under a grant awarded under this part will be utilized to supplement not supplant State funds made available in the year for which the grant is awarded to provide HIV−related services as described in section 300ff−14(b)(1) of this title; (B) that the political subdivisions within the eligible area will maintain the level of expenditures by such political subdivisions for HIV−related services as described in section 300ff−14(b)(1) of this title at a level that is equal to the level of such expenditures by such political subdivisions for the preceding fiscal year; and (C) that political subdivisions within the eligible area will not use funds received under a grant awarded under this part in maintaining the level of expenditures for HIV−related services as required in subparagraph (B); (2) that the eligible area has an HIV health services planning council and has entered into intergovernmental agreements pursuant to section 300ff−12 of this title, and has developed or will develop the comprehensive plan in accordance with section 300ff−12(b)(3)(B) (!1) of this title; (3) that entities within the eligible area that receive funds
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under a grant under this part will maintain appropriate relationships with entities in the eligible area served that constitute key points of access to the health care system for individuals with HIV disease (including emergency rooms, substance abuse treatment programs, detoxification centers, adult and juvenile detention facilities, sexually transmitted disease clinics, HIV counseling and testing sites, mental health programs, and homeless shelters), and other entities under section (!2) 300ff−14(b)(3) and 300ff−52(a) of this title, for the purpose of facilitating early intervention for individuals newly diagnosed with HIV disease and individuals knowledgeable of their HIV status but not in care; (4) that the chief elected official of the eligible area will satisfy all requirements under section 300ff−14(c) of this title; (5) that entities within the eligible area that will receive funds under a grant provided under section 300ff−11(a) of this title shall participate in an established HIV community−based continuum of care if such continuum exists within the eligible area; (6) that funds received under a grant awarded under this part will not be utilized to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to that item or service − (A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
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(B) by an entity that provides health services on a prepaid basis; (7) to the maximum extent practicable, that − (A) HIV health care and support services provided with assistance made available under this part will be provided without regard − (i) to the ability of the individual to pay for such services; and (ii) to the current or past health condition of the individual to be served; (B) such services will be provided in a setting that is accessible to low−income individuals with HIV−disease; and (C) a program of outreach will be provided to low−income individuals with HIV−disease to inform such individuals of such services; (8) that the applicant has participated, or will agree to participate, in the statewide coordinated statement of need process where it has been initiated by the State public health agency responsible for administering grants under part B of this subchapter, and ensure that the services provided under the comprehensive plan are consistent with the statewide coordinated statement of need; and (9) that the eligible area has procedures in place to ensure that services provided with funds received under this part meet the criteria specified in section 300ff−14(b)(1) of this title. (b) Application
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An eligible area that desires to receive a grant under section 300ff−13(b) of this title shall prepare and submit to the Secretary an application, in accordance with subsection (c) of this section regarding a single application and grant award, at such time, in such form, and containing such information as the Secretary shall require, including the information required under such subsection and information concerning − (1) the number of individuals to be served within the eligible area with assistance provided under the grant; (2) demographic data on the population of such individuals; (3) the average cost of providing each category of HIV−related health services and the extent to which such cost is paid by third−party payors; and (4) the aggregate amounts expended for each such category of services. (c) Single application and grant award (1) Application The Secretary may phase in the use of a single application that meets the requirements of subsections (a) and (b) of section 300ff−13 of this title with respect to an eligible area that desires to receive grants under section 300ff−13 of this title for a fiscal year. (2) Grant award The Secretary may phase in the awarding of a single grant to an eligible area that submits an approved application under paragraph (1) for a fiscal year.
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(d) Date certain for submission (1) Requirement Except as provided in paragraph (2), to be eligible to receive a grant under section 300ff−11(a) of this title for a fiscal year, an application under subsection (a) of this section shall be submitted not later than 45 days after the date on which appropriations are made under section 300ff−77 of this title for the fiscal year. (2) Exception The Secretary may extend the time for the submission of an application under paragraph (1) for a period of not to exceed 60 days if the Secretary determines that the eligible area has made a good faith effort to comply with the requirement of such paragraph but has otherwise been unable to submit its application. (3) Distribution by Secretary Not later than 45 days after receiving an application that meets the requirements of subsection (a) of this section from an eligible area, the Secretary shall distribute to such eligible area the amounts awarded under the grant for which the application was submitted. (4) Redistribution Any amounts appropriated in any fiscal year under this part and not obligated to an eligible entity as a result of the failure of such entity to submit an application shall be redistributed by the Secretary to other eligible entities in proportion to the
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original grants made to such eligible areas under section 300ff−11(a) of this title. (e) Requirements regarding imposition of charges for services (1) In general The Secretary may not make a grant under section 300ff−11 of this title to an eligible area unless the eligible area provides assurances that in the provision of services with assistance provided under the grant − (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the provider will not impose charges on any such individual for the provision of services under the grant; (B) in the case of individuals with an income greater than 100 percent of the official poverty line, the provider − (i) will impose a charge on each such individual for the provision of such services; and (ii) will impose the charge according to a schedule of charges that is made available to the public; (C) in the case of individuals with an income greater than 100 percent of the official poverty line and not exceeding 200 percent of such poverty line, the provider will not, for any calendar year, impose charges in an amount exceeding 5 percent of the annual gross income of the individual involved; (D) in the case of individuals with an income greater than 200 percent of the official poverty line and not exceeding 300 percent of such poverty line, the provider will not, for any
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calendar year, impose charges in an amount exceeding 7 percent of the annual gross income of the individual involved; and (E) in the case of individuals with an income greater than 300 percent of the official poverty line, the provider will not, for any calendar year, impose charges in an amount exceeding 10 percent of the annual gross income of the individual involved. (2) Assessment of charge With respect to compliance with the assurance made under paragraph (1), a grantee or entity receiving assistance under this part may, in the case of individuals subject to a charge for purposes of such paragraph − (A) assess the amount of the charge in the discretion of the grantee, including imposing only a nominal charge for the provision of services, subject to the provisions of such paragraph regarding public schedules and regarding limitations on the maximum amount of charges; and (B) take into consideration the medical expenses of individuals in assessing the amount of the charge, subject to such provisions. (3) Applicability of limitation on amount of charge The Secretary may not make a grant under section 300ff−11 of this title to an eligible area unless the eligible area agrees that the limitations established in subparagraphs (C), (D) and (E) of paragraph (1) regarding the imposition of charges for services applies to the annual aggregate of charges imposed for
211
such services, without regard to whether they are characterized as enrollment fees, premiums, deductibles, cost sharing, copayments, coinsurance, or other charges. (4) Waiver regarding secondary agreements The requirements established in paragraphs (1) through (3) shall be waived in accordance with section 300ff−14(d)(2) (!1) of this title. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2605, as added Pub. L. 101−381, title I, Sec. 101(3), Aug. 18, 1990, 104 Stat. 582; amended Pub. L. 104−146, Secs. 3(b)(5), 6(c)(2), May 20, 1996, 110 Stat. 1352, 1368; Pub. L. 106−345, title I, Sec. 122, title V, Sec. 503(a)(1), Oct. 20, 2000, 114 Stat. 1329, 1354.) −REFTEXT− REFERENCES IN TEXT Section 300ff−12(b) of this title, referred to in subsec. (a)(2), was amended by Pub. L. 104−146, Sec. 3(b)(1)(D), May 20, 1996, 110 Stat. 1348, to redesignate pars. (2) and (3) as (3) and (4), respectively. As so redesignated, par. (3)(B) relates to consideration regarding designation of councils and par. (4)(B) relates to development of a comprehensive plan. Section 300ff−14(d)(2) of this title, referred to in subsec. (e)(4), was redesignated section 300ff−14(e)(2) of this title by Pub. L. 106−345, title I, Sec. 121(d)(1), Oct. 20, 2000, 114 Stat. 1328. −MISC1−
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PRIOR PROVISIONS A prior section 2605 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238d of this title. AMENDMENTS 2000 − Subsec. (a)(1)(A). Pub. L. 106−345, Sec. 122(b)(1)(A), substituted "services as described in section 300ff−14(b)(1) of this title" for "services to individuals with HIV disease". Subsec. (a)(1)(B). Pub. L. 106−345, Sec. 122(b)(1)(B), substituted "services as described in section 300ff−14(b)(1) of this title" for "services for individuals with HIV disease". Subsec. (a)(3) to (8). Pub. L. 106−345, Sec. 122(a), added pars. (3) and (4) and redesignated former pars. (3) to (6) as (5) to (8), respectively. Subsec. (a)(9). Pub. L. 106−345, Sec. 122(b)(2)−(4), added par. (9). Subsec. (d)(1). Pub. L. 106−345, Sec. 503(a)(1)(A), made technical amendment to reference in original act which appears in text as reference to section 300ff−77 of this title. Subsec. (d)(4). Pub. L. 106−345, Sec. 503(a)(1)(B), inserted "section" before "300ff−11(a) of this title". 1996 − Subsec. (a). Pub. L. 104−146, Sec. 3(b)(5)(A)(i), inserted ", in accordance with subsection (c) of this section regarding a single application and grant award," after "application" in introductory provisions. Subsec. (a)(1)(B). Pub. L. 104−146, Sec. 3(b)(5)(A)(ii),
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substituted "preceding fiscal year" for "1−year period preceding the first fiscal year for which a grant is received by the eligible area". Subsec. (a)(6). Pub. L. 104−146, Sec. 3(b)(5)(A)(iii)−(v), added par. (6). Subsec. (b). Pub. L. 104−146, Sec. 3(b)(5)(B), substituted "Application" for "Additional application" in heading and substituted "application, in accordance with subsection (c) of this section regarding a single application and grant award," for "additional application" in introductory provisions. Subsec. (c). Pub. L. 104−146, Sec. 3(b)(5)(D), added subsec. (c). Former subsec. (c) redesignated (d). Subsec. (c)(1). Pub. L. 104−146, Sec. 6(c)(2), which directed substitution of "section 300ff−77 of this title" for "section 300ff−18 of this title" in subsec. (c)(1), could not be executed because phrase "section 300ff−18 of this title" did not appear in text of subsec. (c)(1) subsequent to redesignation of subsec. (c) as (d) by Pub. L. 104−146, Sec. 3(b)(5)(C). See below. Subsec. (d). Pub. L. 104−146, Sec. 3(b)(5)(C), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (e). Subsec. (e). Pub. L. 104−146, Sec. 3(b)(5)(C), redesignated subsec. (d) as (e). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title.
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−SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−13, 300ff−14 of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) So in original. Probably should be "sections". −End− −CITE− 42 USC Sec. 300ff−16 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−16. Technical assistance −STATUTE− The Administrator of the Health Resources and Services Administration shall, beginning on August 18, 1990, provide technical assistance, including assistance from other grantees, contractors or subcontractors under this subchapter to assist newly eligible metropolitan areas in the establishment of HIV health services planning councils and, to assist entities in complying with the requirements of this part in order to make such entities
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eligible to receive a grant under this part. The Administrator may make planning grants available to metropolitan areas, in an amount not to exceed $75,000 for any metropolitan area, projected to be eligible for funding under section 300ff−11 of this title in the following fiscal year. Such grant amounts shall be deducted from the first year formula award to eligible areas accepting such grants. Not to exceed 1 percent of the amount appropriated for a fiscal year under section 300ff−77 of this title for grants under this part may be used to carry out this section. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2606, as added Pub. L. 101−381, title I, Sec. 101(3), Aug. 18, 1990, 104 Stat. 585; amended Pub. L. 104−146, Sec. 3(b)(6), May 20, 1996, 110 Stat. 1353.) −MISC1− PRIOR PROVISIONS A prior section 2606 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238e of this title. AMENDMENTS 1996 − Pub. L. 104−146 substituted "Administration shall" for "Administration may", inserted ", including assistance from other grantees, contractors or subcontractors under this subchapter to assist newly eligible metropolitan areas in the establishment of HIV health services planning councils and," after "technical assistance", and inserted at end "The Administrator may make
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planning grants available to metropolitan areas, in an amount not to exceed $75,000 for any metropolitan area, projected to be eligible for funding under section 300ff−11 of this title in the following fiscal year. Such grant amounts shall be deducted from the first year formula award to eligible areas accepting such grants. Not to exceed 1 percent of the amount appropriated for a fiscal year under section 300ff−77 of this title for grants under this part may be used to carry out this section." EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−17 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−17. Definitions −STATUTE− For purposes of this part: (1) Eligible area
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The term "eligible area" means a metropolitan area meeting the requirements of section 300ff−11 of this title that are applicable to the area. (2) Metropolitan area The term "metropolitan area" means an area referred to in the HIV/AIDS Surveillance Report of the Centers for Disease Control and Prevention as a metropolitan area. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2607, as added Pub. L. 101−381, title I, Sec. 101(3), Aug. 18, 1990, 104 Stat. 585; amended Pub. L. 101−557, title IV, Sec. 401(b)(1), Nov. 15, 1990, 104 Stat. 2771; Pub. L. 102−531, title III, Sec. 312(d)(28), Oct. 27, 1992, 106 Stat. 3506; Pub. L. 104−146, Sec. 3(a)(3), May 20, 1996, 110 Stat. 1347.) −MISC1− PRIOR PROVISIONS A prior section 2607 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238f of this title. AMENDMENTS 1996 − Par. (1). Pub. L. 104−146 substituted "The term 'eligible area' means a metropolitan area meeting the requirements of section 300ff−11 of this title that are applicable to the area." for "The term 'eligible area' means a metropolitan area described in section 300ff−11(a) of this title." 1992 − Par. (2). Pub. L. 102−531 substituted "Centers for Disease
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Control and Prevention" for "Centers for Disease Control". 1990 − Par. (1). Pub. L. 101−557 substituted "300ff−11(a)" for "300ff−11(a)(1)". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−18 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part A − Emergency Relief for Areas With Substantial Need for Services −HEAD− Sec. 300ff−18. Repealed. Pub. L. 104−146, Sec. 6(b), May 20, 1996, 110 Stat. 1367 −MISC1− Section, act July 1, 1944, ch. 373, title XXVI, Sec. 2608, as added Aug. 18, 1990, Pub. L. 101−381, title I, Sec. 101(3), 104 Stat. 585, authorized appropriations for fiscal years 1991 through 1995. EFFECTIVE DATE OF REPEAL Repeal effective Oct. 1, 1996, see section 13 of Pub. L. 104−146,
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set out as an Effective Date of 1996 Amendment note under section 300ff−11 of this title. −End− −CITE− 42 USC Part B − Care Grant Program 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program −HEAD− PART B − CARE GRANT PROGRAM −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in sections 300ff−12, 300ff−15, 300ff−27a, 300ff−51, 300ff−71, 300ff−75, 300ff−75b, 300ff−77, 300ff−101 of this title. −End− −CITE− 42 USC subpart i − general grant provisions 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions
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−HEAD− SUBPART I − GENERAL GRANT PROVISIONS −MISC1− AMENDMENTS 1996 − Pub. L. 104−146, Sec. 7(b)(1), May 20, 1996, 110 Stat. 1368, added heading "subpart i − general grant provisions". −End− −CITE− 42 USC Sec. 300ff−21 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−21. Grants −STATUTE− (a) In general The Secretary shall, subject to the availability of appropriations, make grants to States to enable such States to improve the quality, availability and organization of health care and support services for individuals and families with HIV disease. The authority of the Secretary to provide grants under this part is subject to section 300ff−34(e)(2) (!1) of this title (relating to the decrease in perinatal transmission of HIV disease).
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(b) Priority for women, infants and children (1) In general For the purpose of providing health and support services to infants, children, youth, and women with HIV disease, including treatment measures to prevent the perinatal transmission of HIV, a State shall for each of such populations use, of the funds allocated under this part to the State for a fiscal year, not less than the percentage constituted by the ratio of the population involved (infants, children, youth, or women in the State) with acquired immune deficiency syndrome to the general population in the State of individuals with such syndrome. (2) Waiver With respect to the population involved, the Secretary may provide to a State a waiver of the requirement of paragraph (1) if the State demonstrates to the satisfaction of the Secretary that the population is receiving HIV−related health services through the State medicaid program under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], the State children's health insurance program under title XXI of such Act [42 U.S.C. 1397aa et seq.], or other Federal or State programs. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2611, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 586; amended Pub. L. 104−146, Secs. 3(c)(1), 7(b)(2), May 20, 1996, 110 Stat. 1353, 1368; Pub. L. 106−345, title II, Sec. 201, Oct. 20, 2000, 114 Stat. 1329.)
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−REFTEXT− REFERENCES IN TEXT Section 300ff−34(e)(2) of this title, referred to in subsec. (a), was repealed by Pub. L. 106−345, title II, Sec. 211(1), Oct. 20, 2000, 114 Stat. 1339. The Social Security Act, referred to in subsec. (b)(2), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles XIX and XXI of the Act are classified generally to subchapters XIX (Sec. 1396 et seq.) and XXI (Sec. 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. −MISC1− PRIOR PROVISIONS A prior section 2611 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238j of this title. AMENDMENTS 2000 − Subsec. (b). Pub. L. 106−345 amended heading and text of subsec. (b) generally. Prior to amendment, text read as follows: "For the purpose of providing health and support services to infants, children, and women with HIV disease, including treatment measures to prevent the perinatal transmission of HIV, a State shall use, of the funds allocated under this part to the State for a fiscal year, not less than the percentage constituted by the ratio of the population in the State of infants, children, and women with acquired immune deficiency syndrome to the general
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population in the State of individuals with such syndrome." 1996 − Pub. L. 104−146, Sec. 3(c)(1), designated existing provisions as subsec. (a), inserted heading, and added subsec. (b). Subsec. (a). Pub. L. 104−146, Sec. 7(b)(2), inserted at end "The authority of the Secretary to provide grants under this part is subject to section 300ff−34(e)(2) of this title (relating to the decrease in perinatal transmission of HIV disease)." EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−12, 300ff−22, 300ff−27, 300ff−28 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−22 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions
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−HEAD− Sec. 300ff−22. General use of grants −STATUTE− (a) In general A State may use amounts provided under grants made under this part − (1) to provide the services described in section 300ff−14(b)(1) of this title for individuals with HIV disease; (2) to establish and operate HIV care consortia within areas most affected by HIV disease that shall be designed to provide a comprehensive continuum of care to individuals and families with HIV disease in accordance with section 300ff−23 of this title; (3) to provide home− and community−based care services for individuals with HIV disease in accordance with section 300ff−24 of this title; (4) to provide assistance to assure the continuity of health insurance coverage for individuals with HIV disease in accordance with section 300ff−25 of this title; and (5) to provide therapeutics to treat HIV disease to individuals with HIV disease in accordance with section 300ff−26 of this title. Services described in paragraph (1) shall be delivered through consortia designed as described in paragraph (2), where such consortia exist, unless the State demonstrates to the Secretary that delivery of such services would be more effective when other delivery mechanisms are used. In making a determination regarding
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the delivery of services, the State shall consult with appropriate representatives of service providers and recipients of services who would be affected by such determination, and shall include in its demonstration to the Secretary the findings of the State regarding such consultation. (b) Support services; outreach The purposes for which a grant under this part may be used include delivering or enhancing the following: (1) Outpatient and ambulatory support services under section 300ff−21(a) of this title (including case management) to the extent that such services facilitate, enhance, support, or sustain the delivery, continuity, or benefits of health services for individuals and families with HIV disease. (2) Outreach activities that are intended to identify individuals with HIV disease who know their HIV status and are not receiving HIV−related services, and that are − (A) necessary to implement the strategy under section 300ff−27(b)(4)(B) of this title, including activities facilitating the access of such individuals to HIV−related primary care services at entities described in subsection (c)(1) of this section; (B) conducted in a manner consistent with the requirement under section (!1) 300ff−27(b)(6)(G) and 300ff−51(b)(2) of this title; and (C) supplement, and do not supplant, such activities that are carried out with amounts appropriated under section 247b of
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this title. (c) Early intervention services (1) In general The purposes for which a grant under this part may be used include providing to individuals with HIV disease early intervention services described in section 300ff−51(b)(2) of this title, with follow−up referral provided for the purpose of facilitating the access of individuals receiving the services to HIV−related health services. The entities through which such services may be provided under the grant include public health departments, emergency rooms, substance abuse and mental health treatment programs, detoxification centers, detention facilities, clinics regarding sexually transmitted diseases, homeless shelters, HIV disease counseling and testing sites, health care points of entry specified by States or eligible areas, federally qualified health centers, and entities described in section 300ff−52(a) of this title that constitute a point of access to services by maintaining referral relationships. (2) Conditions With respect to an entity that proposes to provide early intervention services under paragraph (1), such paragraph applies only if the entity demonstrates to the satisfaction of the State involved that − (A) Federal, State, or local funds are otherwise inadequate for the early intervention services the entity proposes to provide; and
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(B) the entity will expend funds pursuant to such paragraph to supplement and not supplant other funds available to the entity for the provision of early intervention services for the fiscal year involved. (d) Quality management (1) Requirement Each State that receives a grant under this part shall provide for the establishment of a quality management program to assess the extent to which HIV health services provided to patients under the grant are consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infection, and as applicable, to develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to and quality of HIV health services. (2) Use of funds From amounts received under a grant awarded under this part for a fiscal year, the State may (in addition to amounts to which section 300ff−28(b)(5) of this title applies) use for activities associated with the quality management program required in paragraph (1) not more than the lesser of − (A) 5 percent of amounts received under the grant; or (B) $3,000,000. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2612, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 586; amended
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Pub. L. 104−146, Sec. 3(c)(2), May 20, 1996, 110 Stat. 1354; Pub. L. 106−345, title II, Sec. 202, title V, Sec. 503(b), Oct. 20, 2000, 114 Stat. 1330, 1355.) −COD− CODIFICATION Another section 3(c)(2) of Pub. L. 104−146 amended section 300ff−23 of this title. −MISC1− PRIOR PROVISIONS A prior section 2612 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238k of this title. AMENDMENTS 2000 − Pub. L. 106−345, Sec. 202(1), designated existing provisions as subsec. (a) and inserted heading. Subsec. (a)(1). Pub. L. 106−345, Sec. 503(b), made technical amendment to directory language of Pub. L. 104−146, Sec. 3(c)(2)(A)(iii). See 1996 Amendment note below. Subsec. (b) to (d). Pub. L. 106−345, Sec. 202(2), added subsecs. (b) to (d). 1996 − Pub. L. 104−146, Sec. 3(c)(2)(A), as amended by Pub. L. 106−345, Sec. 503(b), struck out "(a) In general" before "A State may use amounts", added par. (1), redesignated former pars. (1) to (4) as (2) to (5), respectively, substituted "therapeutics to treat HIV disease" for "treatments, that have been determined to prolong life or prevent serious deterioration of health," in par. (5), and
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inserted after par. (5) "Services described in paragraph (1) shall be delivered through consortia designed as described in paragraph (2), where such consortia exist, unless the State demonstrates to the Secretary that delivery of such services would be more effective when other delivery mechanisms are used. In making a determination regarding the delivery of services, the State shall consult with appropriate representatives of service providers and recipients of services who would be affected by such determination, and shall include in its demonstration to the Secretary the findings of the State regarding such consultation." Subsec. (b). Pub. L. 104−146, Sec. 3(c)(2)(B), struck out heading and text of subsec. (b). Text read as follows: "A State shall use not less than 15 percent of funds allocated under this part to provide health and support services to infants, children, women, and families with HIV disease." EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−23, 300ff−24, 300ff−25, 300ff−26, 300ff−27, 300ff−29, 300ff−30, 300ff−51 of this title. −FOOTNOTE− (!1) So in original. Probably should be "sections".
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−End− −CITE− 42 USC Sec. 300ff−23 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−23. Grants to establish HIV care consortia −STATUTE− (a) Consortia A State may use amounts provided under a grant awarded under this part to provide assistance under section 300ff−22(a)(1) (!1) of this title to an entity that − (1) is an association of one or more public, and one or more nonprofit private,(!2) (or private for−profit providers or organizations if such entities are the only available providers of quality HIV care in the area) (!2) health care and support service providers and community based organizations operating within areas determined by the State to be most affected by HIV disease; and (2) agrees to use such assistance for the planning, development and delivery, through the direct provision of services or through entering into agreements with other entities for the provision of
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such services, of comprehensive outpatient health and support services for individuals with HIV disease, that may include − (A) essential health services such as case management services, medical, nursing, substance abuse treatment, mental health treatment, and dental care, diagnostics, monitoring, prophylactic treatment for opportunistic infections, treatment education to take place in the context of health care delivery, and medical follow−up services, mental health, developmental, and rehabilitation services, home health and hospice care; and (B) essential support services such as transportation services, attendant care, homemaker services, day or respite care, benefits advocacy, advocacy services provided through public and nonprofit private entities, and services that are incidental to the provision of health care services for individuals with HIV disease including nutrition services, housing referral services, and child welfare and family services (including foster care and adoption services). An entity or entities of the type described in this subsection shall hereinafter be referred to in this subchapter as a "consortium" or "consortia". (b) Assurances (1) Requirement To receive assistance from a State under subsection (a) of this section, an applicant consortium shall provide the State with assurances that − (A) within any locality in which such consortium is to
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operate, the populations and subpopulations of individuals and families with HIV disease have been identified by the consortium, particularly those experiencing disparities in access and services and those who reside in historically underserved communities; (B) the service plan established under subsection (c)(2) of this section by such consortium is consistent with the comprehensive plan under section 300ff−27(b)(4) of this title and addresses the special care and service needs of the populations and subpopulations identified under subparagraph (A); and (C) except as provided in paragraph (2), the consortium will be a single coordinating entity that will integrate the delivery of services among the populations and subpopulations identified under subparagraph (A). (2) Exception Subparagraph (C) of paragraph (1) shall not apply to any applicant consortium that the State determines will operate in a community or locality in which it has been demonstrated by the applicant consortium that − (A) subpopulations exist within the community to be served that have unique service requirements; and (B) such unique service requirements cannot be adequately and efficiently addressed by a single consortium serving the entire community or locality. (c) Application
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(1) In general To receive assistance from the State under subsection (a) of this section, a consortium shall prepare and submit to the State, an application that − (A) demonstrates that the consortium includes agencies and community−based organizations − (i) with a record of service to populations and subpopulations with HIV disease requiring care within the community to be served; and (ii) that are representative of populations and subpopulations reflecting the local incidence of HIV and that are located in areas in which such populations reside; (B) demonstrates that the consortium has carried out an assessment of service needs within the geographic area to be served and, after consultation with the entities described in paragraph (2), has established a plan to ensure the delivery of services to meet such identified needs that shall include − (i) assurances that service needs will be addressed through the coordination and expansion of existing programs before new programs are created; (ii) assurances that, in metropolitan areas, the geographic area to be served by the consortium corresponds to the geographic boundaries of local health and support services delivery systems to the extent practicable; (iii) assurances that, in the case of services for individuals residing in rural areas, the applicant consortium
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shall deliver case management services that link available community support services to appropriate specialized medical services; and (iv) assurances that the assessment of service needs and the planning of the delivery of services will include participation by individuals with HIV disease; (C) demonstrates that adequate planning has occurred to meet the special needs of families with HIV disease, including family centered and youth centered care; (D) demonstrates that the consortium has created a mechanism to evaluate periodically − (i) the success of the consortium in responding to identified needs; and (ii) the cost−effectiveness of the mechanisms employed by the consortium to deliver comprehensive care; (E) demonstrates that the consortium will report to the State the results of the evaluations described in subparagraph (D) and shall make available to the State or the Secretary, on request, such data and information on the program methodology that may be required to perform an independent evaluation; and (F) demonstrates that adequate planning occurred to address disparities in access and services and historically underserved communities. (2) Consultation In establishing the plan required under paragraph (1)(B), the consortium shall consult with −
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(A)(i) the public health agency that provides or supports ambulatory and outpatient HIV−related health care services within the geographic area to be served; or (ii) in the case of a public health agency that does not directly provide such HIV−related health care services such agency shall consult with an entity or entities that directly provide ambulatory and outpatient HIV−related health care services within the geographic area to be served; (B) not less than one community−based organization that is organized solely for the purpose of providing HIV−related support services to individuals with HIV disease; (C) grantees under section 300ff−71 of this title, or, if none are operating in the area, representatives in the area of organizations with a history of serving children, youth, women, and families living with HIV; and (D) the types of entities described in section 300ff−12(b)(2) of this title. The organization to be consulted under subparagraph (B) shall be at the discretion of the applicant consortium. (d) "Family centered care" defined As used in this part, the term "family centered care" means the system of services described in this section that is targeted specifically to the special needs of infants, children, women, and families. Family centered care shall be based on a partnership between parents, professionals, and the community designed to ensure an integrated, coordinated, culturally sensitive, and
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community−based continuum of care for children, women, and families with HIV disease. (e) Priority In providing assistance under subsection (a) of this section, the State shall, among applicants that meet the requirements of this section, give priority − (1) first to consortia that are receiving assistance from the Health Resources and Services Administration for adult and pediatric HIV−related care demonstration projects; and then (2) to any other existing HIV care consortia. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2613, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 586; amended Pub. L. 104−146, Sec. 3(c)(2), May 20, 1996, 110 Stat. 1354; Pub. L. 106−345, title II, Sec. 203, Oct. 20, 2000, 114 Stat. 1331.) −REFTEXT− REFERENCES IN TEXT Section 300ff−22 of this title, referred to in subsec. (a), was amended by Pub. L. 104−146, Sec. 3(c)(2)(A)(i), (ii), May 20, 1996, 110 Stat. 1354, and Pub. L. 106−345, title II, Sec. 202(1), Oct. 20, 2000, 114 Stat. 1330, and as so amended, provisions formerly contained in section 300ff−22(a)(1) are now contained in section 300ff−22(a)(2). −COD− CODIFICATION Another section 3(c)(2) of Pub. L. 104−146 amended section
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300ff−22 of this title. −MISC1− PRIOR PROVISIONS A prior section 2613 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238l of this title. AMENDMENTS 2000 − Subsec. (b)(1)(A). Pub. L. 106−345, Sec. 203(1)(A), inserted ", particularly those experiencing disparities in access and services and those who reside in historically underserved communities" before semicolon. Subsec. (b)(1)(B). Pub. L. 106−345, Sec. 203(1)(B), inserted "is consistent with the comprehensive plan under section 300ff−27(b)(4) of this title and" after "by such consortium". Subsec. (c)(1)(F). Pub. L. 106−345, Sec. 203(2), added subpar. (F). Subsec. (c)(2)(D). Pub. L. 106−345, Sec. 203(3), added subpar. (D). 1996 − Subsec. (a)(1). Pub. L. 104−146, Sec. 3(c)(2)(A)(i), inserted "(or private for−profit providers or organizations if such entities are the only available providers of quality HIV care in the area)" after "nonprofit private,". Subsec. (a)(2)(A). Pub. L. 104−146, Sec. 3(c)(2)(A)(ii), inserted "substance abuse treatment, mental health treatment," after "nursing," and "prophylactic treatment for opportunistic infections, treatment education to take place in the context of
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health care delivery," after "monitoring,". Subsec. (c)(1)(C). Pub. L. 104−146, Sec. 3(c)(2)(B)(i), inserted "and youth centered" after "family centered". Subsec. (c)(2)(C). Pub. L. 104−146, Sec. 3(c)(2)(B)(ii), added subpar. (C). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−22, 300ff−28 of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) So in original. The comma probably should follow parenthetical phrase. −End− −CITE− 42 USC Sec. 300ff−24 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions
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−HEAD− Sec. 300ff−24. Grants for home− and community−based care −STATUTE− (a) Uses A State may use amounts provided under a grant awarded under this part to make grants under section 300ff−22(a)(2) (!1) of this title to entities to − (1) provide home− and community−based health services for individuals with HIV disease pursuant to written plans of care prepared by a case management team, that shall include appropriate health care professionals, in such State for providing such services to such individuals; (2) provide outreach services to individuals with HIV disease, including those individuals in rural areas; and (3) provide for the coordination of the provision of services under this section with the provision of HIV−related health services provided by public and private entities. (b) Priority In awarding grants under subsection (a) of this section, a State shall give priority to entities that provide assurances to the State that − (1) such entities will participate in HIV care consortia if such consortia exist within the State; and (2) such entities will utilize amounts provided under such grants for the provision of home− and community−based services to low−income individuals with HIV disease.
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(c) "Home− and community−based health services" defined As used in this part, the term "home− and community−based health services" − (1) means, with respect to an individual with HIV disease, skilled health services furnished to the individual in the individual's home pursuant to a written plan of care established by a case management team, that shall include appropriate health care professionals, for the provision of such services and items described in paragraph (2); (2) includes − (A) durable medical equipment; (B) homemaker or home health aide services and personal care services furnished in the home of the individual; (C) day treatment or other partial hospitalization services; (D) home intravenous and aerosolized drug therapy (including prescription drugs administered as part of such therapy); (E) routine diagnostic testing administered in the home of the individual; and (F) appropriate mental health, developmental, and rehabilitation services; and (3) does not include − (A) inpatient hospital services; and (B) nursing home and other long term care facilities. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2614, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 589.)
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−REFTEXT− REFERENCES IN TEXT Section 300ff−22 of this title, referred to in subsec. (a), was amended by Pub. L. 104−146, Sec. 3(c)(2)(A)(i), (ii), May 20, 1996, 110 Stat. 1354, and Pub. L. 106−345, title II, Sec. 202(1), Oct. 20, 2000, 114 Stat. 1330, and as so amended, provisions formerly contained in section 300ff−22(a)(2) are now contained in section 300ff−22(a)(3). −MISC1− PRIOR PROVISIONS A prior section 2614 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238m of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ff−22 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−25 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program
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subpart i − general grant provisions −HEAD− Sec. 300ff−25. Continuum of health insurance coverage −STATUTE− (a) In general A State may use amounts received under a grant awarded under this part to establish a program of financial assistance under section 300ff−22(a)(3) (!1) of this title to assist eligible low−income individuals with HIV disease in − (1) maintaining a continuity of health insurance; or (2) receiving medical benefits under a health insurance program, including risk−pools. (b) Limitations Assistance shall not be utilized under subsection (a) of this section − (1) to pay any costs associated with the creation, capitalization, or administration of a liability risk pool (other than those costs paid on behalf of individuals as part of premium contributions to existing liability risk pools); and (2) to pay any amount expended by a State under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.]. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2615, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 590.) −REFTEXT− REFERENCES IN TEXT
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Section 300ff−22 of this title, referred to in subsec. (a), was amended by Pub. L. 104−146, Sec. 3(c)(2)(A)(i), (ii), May 20, 1996, 110 Stat. 1354, and Pub. L. 106−345, title II, Sec. 202(1), Oct. 20, 2000, 114 Stat. 1330, and as so amended, provisions formerly contained in section 300ff−22(a)(3) are now contained in section 300ff−22(a)(4). The Social Security Act, referred to in subsec. (b)(2), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX of the Social Security Act is classified generally to subchapter XIX (Sec. 1396 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. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−22, 300ff−27 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−26 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program
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subpart i − general grant provisions −HEAD− Sec. 300ff−26. Provision of treatments −STATUTE− (a) In general A State shall use a portion of the amounts provided under a grant awarded under this part to establish a program under section 300ff−22(a)(5) of this title to provide therapeutics to treat HIV disease or prevent the serious deterioration of health arising from HIV disease in eligible individuals, including measures for the prevention and treatment of opportunistic infections. (b) Eligible individual To be eligible to receive assistance from a State under this section an individual shall − (1) have a medical diagnosis of HIV disease; and (2) be a low−income individual, as defined by the State. (c) State duties In carrying out this section the State shall − (1) determine, in accordance with guidelines issued by the Secretary, which treatments are eligible to be included under the program established under this section; (2) provide assistance for the purchase of treatments determined to be eligible under paragraph (1), and the provision of such ancillary devices that are essential to administer such treatments; (3) provide outreach to individuals with HIV disease, and as
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appropriate to the families of such individuals; (4) facilitate access to treatments for such individuals; (5) document the progress made in making therapeutics described in subsection (a) of this section available to individuals eligible for assistance under this section; and (6) encourage, support, and enhance adherence to and compliance with treatment regimens, including related medical monitoring. Of the amount reserved by a State for a fiscal year for use under this section, the State may not use more than 5 percent to carry out services under paragraph (6), except that the percentage applicable with respect to such paragraph is 10 percent if the State demonstrates to the Secretary that such additional services are essential and in no way diminish access to the therapeutics described in subsection (a) of this section. (d) Duties of Secretary In carrying out this section, the Secretary shall review the current status of State drug reimbursement programs established under section 300ff−22(2) (!1) of this title and assess barriers to the expanded availability of the treatments described in subsection (a) of this section. The Secretary shall also examine the extent to which States coordinate with other grantees under this subchapter to reduce barriers to the expanded availability of the treatments described in subsection (a) of this section. (e) Use of health insurance and plans (1) In general In carrying out subsection (a) of this section, a State may
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expend a grant under this part to provide the therapeutics described in such subsection by paying on behalf of individuals with HIV disease the costs of purchasing or maintaining health insurance or plans whose coverage includes a full range of such therapeutics and appropriate primary care services. (2) Limitation The authority established in paragraph (1) applies only to the extent that, for the fiscal year involved, the costs of the health insurance or plans to be purchased or maintained under such paragraph do not exceed the costs of otherwise providing therapeutics described in subsection (a) of this section. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2616, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 590; amended Pub. L. 104−146, Sec. 3(c)(3), May 20, 1996, 110 Stat. 1355; Pub. L. 106−345, title II, Sec. 204, Oct. 20, 2000, 114 Stat. 1332.) −REFTEXT− REFERENCES IN TEXT Section 300ff−22(2) of this title, referred to in subsec. (d), was redesignated section 300ff−22(a)(2) of this title by Pub. L. 106−345, title II, Sec. 202(1), Oct. 20, 2000, 114 Stat. 1330. −MISC1− AMENDMENTS 2000 − Subsec. (c). Pub. L. 106−345, Sec. 204(a), added par. (6) and concluding provisions. Subsec. (e). Pub. L. 106−345, Sec. 204(b), added subsec. (e).
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1996 − Subsec. (a). Pub. L. 104−146, Sec. 3(c)(3)(A), substituted "shall use a portion of the amounts" for "may use amounts" and "section 300ff−22(a)(5) of this title to provide therapeutics to treat HIV disease" for "section 300ff−22(a)(4) of this title to provide treatments that have been determined to prolong life" and inserted before period ", including measures for the prevention and treatment of opportunistic infections". Subsec. (c)(5). Pub. L. 104−146, Sec. 3(c)(3)(B), added par. (5). Subsec. (d). Pub. L. 104−146, Sec. 3(c)(3)(C), added subsec. (d). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−22, 300ff−28 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−27 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM
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Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−27. State application −STATUTE− (a) In general The Secretary shall not make a grant to a State under this part for a fiscal year unless the State prepares and submits, to the Secretary, an application at such time, in such form, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this part. (b) Description of intended uses and agreements The application submitted under subsection (a) of this section shall contain − (1) a detailed description of the HIV−related services provided in the State to individuals and families with HIV disease during the year preceding the year for which the grant is requested, and the number of individuals and families receiving such services, that shall include − (A) a description of the types of programs operated or funded by the State for the provision of HIV−related services during the year preceding the year for which the grant is requested and the methods utilized by the State to finance such programs; (B) an accounting of the amount of funds that the State has expended for such services and programs during the year preceding the year for which the grant is requested; and
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(C) information concerning − (i) the number of individuals to be served with assistance provided under the grant; (ii) demographic data on the population of the individuals to be served; (iii) the average cost of providing each category of HIV−related health services and the extent to which such cost is paid by third−party payors; and (iv) the aggregate amounts expended for each such category of services; (2) a determination of the size and demographics of the population of individuals with HIV disease in the State; (3) a determination of the needs of such population, with particular attention to − (A) individuals with HIV disease who know their HIV status and are not receiving HIV−related services; and (B) disparities in access and services among affected subpopulations and historically underserved communities; (4) a comprehensive plan that describes the organization and delivery of HIV health care and support services to be funded with assistance received under this part that shall include a description of the purposes for which the State intends to use such assistance, and that − (A) establishes priorities for the allocation of funds within the State based on − (i) size and demographics of the population of individuals
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with HIV disease (as determined under paragraph (2)) and the needs of such population (as determined under paragraph (3)); (ii) availability of other governmental and non−governmental resources, including the State medicaid plan under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] and the State Children's Health Insurance Program under title XXI of such Act [42 U.S.C. 1397aa et seq.] to cover health care costs of eligible individuals and families with HIV disease; (iii) capacity development needs resulting from disparities in the availability of HIV−related services in historically underserved communities and rural communities; and (iv) the efficiency of the administrative mechanism of the State for rapidly allocating funds to the areas of greatest need within the State; (B) includes a strategy for identifying individuals who know their HIV status and are not receiving such services and for informing the individuals of and enabling the individuals to utilize the services, giving particular attention to eliminating disparities in access and services among affected subpopulations and historically underserved communities, and including discrete goals, a timetable, and an appropriate allocation of funds; (C) includes a strategy to coordinate the provision of such services with programs for HIV prevention (including outreach and early intervention) and for the prevention and treatment of
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substance abuse (including programs that provide comprehensive treatment services for such abuse); (D) describes the services and activities to be provided and an explanation of the manner in which the elements of the program to be implemented by the State with such assistance will maximize the quality of health and support services available to individuals with HIV disease throughout the State; (E) provides a description of the manner in which services funded with assistance provided under this part will be coordinated with other available related services for individuals with HIV disease; and (F) provides a description of how the allocation and utilization of resources are consistent with the statewide coordinated statement of need (including traditionally underserved populations and subpopulations) developed in partnership with other grantees in the State that receive funding under this subchapter; and (!1) (5) an assurance that the public health agency administering the grant for the State will periodically convene a meeting of individuals with HIV disease, representatives of grantees under each part under this subchapter, providers, and public agency representatives for the purpose of developing a statewide coordinated statement of need; and (6) an assurance by the State that − (A) the public health agency that is administering the grant for the State engages in a public advisory planning process,
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including public hearings, that includes the participants under paragraph (5), and the types of entities described in section 300ff−12(b)(2) of this title, in developing the comprehensive plan under paragraph (4) and commenting on the implementation of such plan; (B) the State will − (i) to the maximum extent practicable, ensure that HIV−related health care and support services delivered pursuant to a program established with assistance provided under this part will be provided without regard to the ability of the individual to pay for such services and without regard to the current or past health condition of the individual with HIV disease; (ii) ensure that such services will be provided in a setting that is accessible to low−income individuals with HIV disease; (iii) provide outreach to low−income individuals with HIV disease to inform such individuals of the services available under this part; and (iv) in the case of a State that intends to use amounts provided under the grant for purposes described in section 300ff−25 of this title, submit a plan to the Secretary that demonstrates that the State has established a program that assures that − (I) such amounts will be targeted to individuals who would not otherwise be able to afford health insurance
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coverage; and (II) income, asset, and medical expense criteria will be established and applied by the State to identify those individuals who qualify for assistance under such program, and information concerning such criteria shall be made available to the public; (C) the State will provide for periodic independent peer review to assess the quality and appropriateness of health and support services provided by entities that receive funds from the State under this part; (D) the State will permit and cooperate with any Federal investigations undertaken regarding programs conducted under this part; (E) the State will maintain HIV−related activities at a level that is equal to not less than the level of such expenditures by the State for the 1−year period preceding the fiscal year for which the State is applying to receive a grant under this part; (F) the State will ensure that grant funds are not utilized to make payments for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to that item or service − (i) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or (ii) by an entity that provides health services on a
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prepaid basis; and (G) entities within areas in which activities under the grant are carried out will maintain appropriate relationships with entities in the area served that constitute key points of access to the health care system for individuals with HIV disease (including emergency rooms, substance abuse treatment programs, detoxification centers, adult and juvenile detention facilities, sexually transmitted disease clinics, HIV counseling and testing sites, mental health programs, and homeless shelters), and other entities under section (!2) 300ff−22(c) and 300ff−52(a) of this title, for the purpose of facilitating early intervention for individuals newly diagnosed with HIV disease and individuals knowledgeable of their HIV status but not in care. (c) Requirements regarding imposition of charges for services (1) In general The Secretary may not make a grant under section 300ff−21 of this title to a State unless the State provides assurances that in the provision of services with assistance provided under the grant − (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the provider will not impose charges on any such individual for the provision of services under the grant; (B) in the case of individuals with an income greater than 100 percent of the official poverty line, the provider −
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(i) will impose charges on each such individual for the provision of such services; and (ii) will impose charges according to a schedule of charges that is made available to the public; (C) in the case of individuals with an income greater than 100 percent of the official poverty line and not exceeding 200 percent of such poverty line, the provider will not, for any calendar year, impose charges in an amount exceeding 5 percent of the annual gross income of the individual involved; (D) in the case of individuals with an income greater than 200 percent of the official poverty line and not exceeding 300 percent of such poverty line, the provider will not, for any calendar year, impose charges in an amount exceeding 7 percent of the annual gross income of the individual involved; and (E) in the case of individuals with an income greater than 300 percent of the official poverty line, the provider will not, for any calendar year, impose charges in an amount exceeding 10 percent of the annual gross income of the individual involved. (2) Assessment of charge With respect to compliance with the assurance made under paragraph (1), a grantee under this part may, in the case of individuals subject to a charge for purposes of such paragraph − (A) assess the amount of the charge in the discretion of the grantee, including imposing only a nominal charge for the provision of services, subject to the provisions of such
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paragraph regarding public schedules regarding limitation on the maximum amount of charges; and (B) take into consideration the medical expenses of individuals in assessing the amount of the charge, subject to such provisions. (3) Applicability of limitation on amount of charge The Secretary may not make a grant under section 300ff−21 of this title unless the applicant of the grant agrees that the limitations established in subparagraphs (C), (D), and (E) of paragraph (1) regarding the imposition of charges for services applies to the annual aggregate of charges imposed for such services, without regard to whether they are characterized as enrollment fees, premiums, deductibles, cost sharing, copayments, coinsurance, or other charges. (4) Waiver (A) In general The State shall waive the requirements established in paragraphs (1) through (3) in the case of an entity that does not, in providing health care services, impose a charge or accept reimbursement from any third−party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program. (B) Determination A determination by the State of whether an entity referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the entity
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accepts voluntary donations regarding the provision of services to the public. (d) Requirement of matching funds regarding State allotments (1) In general In the case of any State to which the criterion described in paragraph (3) applies, the Secretary may not make a grant under this part unless the State agrees that, with respect to the costs to be incurred by the State in carrying out the program for which the grant was awarded, the State will, subject to subsection (b)(2) (!3) of this section, make available (directly or through donations from public or private entities) non−Federal contributions toward such costs in an amount equal to − (A) for the first fiscal year of payments under the grant, not less than 16 2/3 percent of such costs ($1 for each $5 of Federal funds provided in the grant); (B) for any second fiscal year of such payments, not less than 20 percent of such costs ($1 for each $4 of Federal funds provided in the grant); (C) for any third fiscal year of such payments, not less than 25 percent of such costs ($1 for each $3 of Federal funds provided in the grant); (D) for any fourth fiscal year of such payments, not less than 33 1/3 percent of such costs ($1 for each $2 of Federal funds provided in the grant); and (E) for any subsequent fiscal year of such payments, not less than 33 1/3 percent of such costs ($1 for each $2 of Federal
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funds provided in the grant). (2) Determination of amount of non−Federal contribution (A) In general Non−Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non−Federal contributions. (B) Inclusion of certain amounts (i) In making a determination of the amount of non−Federal contributions made by a State for purposes of paragraph (1), the Secretary shall, subject to clause (ii), include any non−Federal contributions provided by the State for HIV−related services, without regard to whether the contributions are made for programs established pursuant to this subchapter; (ii) In making a determination for purposes of clause (i), the Secretary may not include any non−Federal contributions provided by the State as a condition of receiving Federal funds under any program under this subchapter (except for the program established in this part) or under other provisions of law. (3) Applicability of requirement (A) Number of cases A State referred to in paragraph (1) is any State for which the number of cases of acquired immune deficiency syndrome reported to and confirmed by the Director of the Centers for
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Disease Control and Prevention for the period described in subparagraph (B) constitutes in excess of 1 percent of the aggregate number of such cases reported to and confirmed by the Director for such period for the United States. (B) Period of time The period referred to in subparagraph (A) is the 2−year period preceding the fiscal year for which the State involved is applying to receive a grant under subsection (a) of this section. (C) Puerto Rico For purposes of paragraph (1), the number of cases of acquired immune deficiency syndrome reported and confirmed for the Commonwealth of Puerto Rico for any fiscal year shall be deemed to be less than 1 percent. (4) Diminished State contribution With respect to a State that does not make available the entire amount of the non−Federal contribution referred to in paragraph (1), the State shall continue to be eligible to receive Federal funds under a grant under this part, except that the Secretary in providing Federal funds under the grant shall provide such funds (in accordance with the ratios prescribed in paragraph (1)) only with respect to the amount of funds contributed by such State. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2617, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 590; amended Pub. L. 102−531, title III, Sec. 312(d)(29), Oct. 27, 1992, 106
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Stat. 3506; Pub. L. 104−146, Secs. 3(c)(4), 12(c)(3), May 20, 1996, 110 Stat. 1355, 1373; Pub. L. 106−345, title II, Sec. 205, Oct. 20, 2000, 114 Stat. 1332.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in subsec. (b)(4)(A)(ii), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles XIX and XXI of the Act are classified generally to subchapters XIX (Sec. 1396 et seq.) and XXI (Sec. 1397aa et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. Subsection (b)(2) of this section, referred to in subsec. (d)(1), was redesignated subsec. (b)(4) by Pub. L. 106−345, title II, Sec. 205(a)(1), Oct. 20, 2000, 114 Stat. 1332. −MISC1− AMENDMENTS 2000 − Subsec. (b)(2), (3). Pub. L. 106−345, Sec. 205(a)(2), added pars. (2) and (3). Former pars. (2) and (3) redesignated (4) and (5), respectively. Subsec. (b)(4). Pub. L. 106−345, Sec. 205(a)(3)(A), (B), in introductory provisions substituted "comprehensive plan that describes the organization" for "comprehensive plan for the organization" and ", and that − " for ", including − ". Pub. L. 106−345, Sec. 205(a)(1), redesignated par. (2) as (4). Former par. (4) redesignated (6). Subsec. (b)(4)(A) to (C). Pub. L. 106−345, Sec. 205(a)(3)(D),
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which directed the amendment of par. (4) by adding subpars. (A) to (C) "before subparagraph (C)", was executed by adding them before subpar. (D), to reflect the probable intent of Congress. Former subpars. (A) to (C) redesignated (D) to (F), respectively. Subsec. (b)(4)(D). Pub. L. 106−345, Sec. 205(a)(3)(C), (E), redesignated subpar. (A) as (D) and inserted "describes" before "the services and activities". Subsec. (b)(4)(E). Pub. L. 106−345, Sec. 205(a)(3)(C), (F), redesignated subpar. (B) as (E) and inserted "provides" before "a description". Subsec. (b)(4)(F). Pub. L. 106−345, Sec. 205(a)(3)(C), (G), redesignated subpar. (C) as (F) and inserted "provides" before "a description". Subsec. (b)(5). Pub. L. 106−345, Sec. 205(a)(1), (b)(1), redesignated par. (3) as (5) and substituted "HIV disease" for "HIV". Subsec. (b)(6). Pub. L. 106−345, Sec. 205(a)(1), redesignated par. (4) as (6). Subsec. (b)(6)(A). Pub. L. 106−345, Sec. 205(b)(2), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "the public health agency that is administering the grant for the State will conduct public hearings concerning the proposed use and distribution of the assistance to be received under this part;". Subsec. (b)(6)(G). Pub. L. 106−345, Sec. 205(c), added subpar. (G).
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1996 − Subsec. (b)(2)(C). Pub. L. 104−146, Sec. 3(c)(4)(A), added subpar. (C). Subsec. (b)(3). Pub. L. 104−146, Sec. 3(c)(4)(C), added par. (3). Former par. (3) redesignated (4). Subsec. (b)(4). Pub. L. 104−146, Sec. 3(c)(4)(B), redesignated par. (3) as (4). Subsec. (b)(4)(B)(iv). Pub. L. 104−146, Sec. 12(c)(3), which directed amendment of par. (3)(B)(iv) by inserting "section" before "300ff−25", was executed by making the amendment in par. (4)(B)(iv) to reflect the probable intent of Congress and the redesignation of par. (3) as (4) by Pub. L. 104−146, Sec. 3(c)(4)(B). See above. 1992 − Subsec. (d)(3)(A). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−12, 300ff−22, 300ff−23, 300ff−30 of this title. −FOOTNOTE− (!1) So in original. The word "and" probably should not appear. (!2) So in original. Probably should be "sections". (!3) See References in Text note below.
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−End− −CITE− 42 USC Sec. 300ff−27a 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−27a. Spousal notification −STATUTE− (a) In general The Secretary of Health and Human Services shall not make a grant under part B of title XXVI of the Public Health Service Act (42 U.S.C. 300ff−21 et seq.) to any State unless such State takes administrative or legislative action to require that a good faith effort be made to notify a spouse of a known HIV−infected patient that such spouse may have been exposed to the human immunodeficiency virus and should seek testing. (b) Definitions For purposes of this section: (1) Spouse The term "spouse" means any individual who is the marriage partner of an HIV−infected patient, or who has been the marriage partner of that patient at any time within the 10−year period
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prior to the diagnosis of HIV infection. (2) HIV−infected patient The term "HIV−infected patient" means any individual who has been diagnosed to be infected with the human immunodeficiency virus. (3) State The term "State" means any of the 50 States, the District of Columbia, or any territory of the United States. −SOURCE− (Pub. L. 104−146, Sec. 8, May 20, 1996, 110 Stat. 1372.) −REFTEXT− REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (a), is act July 1, 1944, ch. 373, 58 Stat. 682, as amended. Part B of title XXVI of the Act is classified generally to this part. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables. −COD− CODIFICATION Section was enacted as part of the Ryan White CARE Act Amendments of 1996, and not as part of the Public Health Service Act which comprises this chapter. −MISC1− EFFECTIVE DATE Section effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as an Effective Date of 1996 Amendment note under
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section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−28 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−28. Distribution of funds −STATUTE− (a) Amount of grant to State (1) Minimum allotment Subject to the extent of amounts made available under section 300ff−77 of this title, the amount of a grant to be made under this part for − (A) each of the several States and the District of Columbia for a fiscal year shall be the greater of − (i)(I) with respect to a State or District that has less than 90 living cases of acquired immune deficiency syndrome, as determined under paragraph (2)(D), $200,000; or (II) with respect to a State or District that has 90 or more living cases of acquired immune deficiency syndrome, as determined under paragraph (2)(D), $500,000;
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(ii) an amount determined under paragraph (2) and then, as applicable, increased under paragraph (2)(H); and (B) each territory of the United States, as defined in paragraph (3), shall be the greater of $50,000 or an amount determined under paragraph (2). (2) Determination (A) Formula The amount referred to in paragraph (1)(A)(ii) for a State and paragraph (1)(B) for a territory of the United States shall be the product of − (i) an amount equal to the amount appropriated under section 300ff−77 of this title for the fiscal year involved for grants under this part, subject to subparagraphs (H) and (I); and (ii) the percentage constituted by the sum of − (I) the product of .80 and the ratio of the State distribution factor for the State or territory (as determined under subsection (B)) to the sum of the respective State distribution factors for all States or territories; and (II) the product of .20 and the ratio of the non−EMA distribution factor for the State or territory (as determined under subparagraph (C)) to the sum of the respective distribution factors for all States or territories. (B) State distribution factor
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For purposes of subparagraph (A)(ii)(I), the term "State distribution factor" means an amount equal to the estimated number of living cases of acquired immune deficiency syndrome in the eligible area involved, as determined under subparagraph (D). (C) Non−EMA distribution factor For purposes of subparagraph (A)(ii)(II), the term "non−ema (!1) distribution factor" means an amount equal to the sum of − (i) the estimated number of living cases of acquired immune deficiency syndrome in the State or territory involved, as determined under subparagraph (D); less (ii) the estimated number of living cases of acquired immune deficiency syndrome in such State or territory that are within an eligible area (as determined under part A of this subchapter). (D) Estimate of living cases The amount determined in this subparagraph is an amount equal to the product of − (i) the number of cases of acquired immune deficiency syndrome in the State or territory during each year in the most recent 120−month period for which data are available with respect to all States and territories, as indicated by the number of such cases reported to and confirmed by the Director of the Centers for Disease Control and Prevention for each year during such period, except that (subject to subparagraph (E)), for grants made pursuant to this paragraph
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or section 300ff−30 of this title for fiscal year 2005 and subsequent fiscal years, the cases counted for each 12−month period beginning on or after July 1, 2004, shall be cases of HIV disease (as reported to and confirmed by such Director) rather than cases of acquired immune deficiency syndrome; and (ii) with respect to each of the first through the tenth year during such period, the amount referred to in section 300ff−13(a)(3)(C)(ii) of this title. (E) Determination of Secretary regarding data on HIV cases If under section 300ff−13(a)(3)(D)(i) of this title the Secretary determines that data on cases of HIV disease are not sufficiently accurate and reliable, then notwithstanding subparagraph (D) of this paragraph, for any fiscal year prior to fiscal year 2007 the references in such subparagraph to cases of HIV disease do not have any legal effect. (F) Puerto Rico, Virgin Islands, Guam For purposes of subparagraph (D), the cost index for Puerto Rico, the Virgin Islands, and Guam shall be 1.0. (G) Unexpended funds The Secretary may, in determining the amount of a grant for a fiscal year under this subsection, adjust the grant amount to reflect the amount of unexpended and uncanceled grant funds remaining at the end of the fiscal year preceding the year for which the grant determination is to be made. The amount of any such unexpended funds shall be determined using the financial status report of the grantee.
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(H) Limitation (i) In general The Secretary shall ensure that the amount of a grant awarded to a State or territory under section 300ff−21 of this title or subparagraph (I)(i) for a fiscal year is not less than − (I) with respect to fiscal year 2001, 99 percent; (II) with respect to fiscal year 2002, 98 percent; (III) with respect to fiscal year 2003, 97 percent; (IV) with respect to fiscal year 2004, 96 percent; and (V) with respect to fiscal year 2005, 95 percent, of the amount such State or territory received for fiscal year 2000 under section 300ff−21 of this title or subparagraph (I)(i), respectively (notwithstanding such subparagraph). In administering this subparagraph, the Secretary shall, with respect to States or territories that will under such section receive grants in amounts that exceed the amounts that such States received under such section or subparagraph for fiscal year 2000, proportionally reduce such amounts to ensure compliance with this subparagraph. In making such reductions, the Secretary shall ensure that no such State receives less than that State received for fiscal year 2000. (ii) Ratable reduction If the amount appropriated under section 300ff−77 of this title for a fiscal year and available for grants under
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section 300ff−21 of this title or subparagraph (I)(i) is less than the amount appropriated and available for fiscal year 2000 under section 300ff−21 of this title or subparagraph (I)(i), respectively, the limitation contained in clause (i) for the grants involved shall be reduced by a percentage equal to the percentage of the reduction in such amounts appropriated and available. (I) Appropriations for treatment drug program (i) Formula grants With respect to the fiscal year involved, if under section 300ff−77 of this title an appropriations Act provides an amount exclusively for carrying out section 300ff−26 of this title, the portion of such amount allocated to a State shall be the product of − (I) 100 percent of such amount, less the percentage reserved under clause (ii)(V); and (II) the percentage constituted by the ratio of the State distribution factor for the State (as determined under subparagraph (B)) to the sum of the State distribution factors for all States. (ii) Supplemental treatment drug grants (I) In general From amounts made available under subclause (V), the Secretary shall make supplemental grants to States described in subclause (II) to enable such States to increase access to therapeutics described in section
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300ff−26(a) of this title, as provided by the State under section 300ff−26(c)(2) of this title. (II) Eligible States For purposes of subclause (I), a State described in this subclause is a State that, in accordance with criteria established by the Secretary, demonstrates a severe need for a grant under such subclause. In developing such criteria, the Secretary shall consider eligibility standards, formulary composition, and the number of eligible individuals at or below 200 percent of the official poverty line to whom the State is unable to provide therapeutics described in section 300ff−26(a) of this title. (III) State requirements The Secretary may not make a grant to a State under this clause unless the State agrees that − (aa) the State will make available (directly or through donations from public or private entities) non−Federal contributions toward the activities to be carried out under the grant in an amount equal to $1 for each $4 of Federal funds provided in the grant; and (bb) the State will not impose eligibility requirements for services or scope of benefits limitations under section 300ff−26(a) of this title that are more restrictive than such requirements in effect as of January 1, 2000.
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(IV) Use and coordination Amounts made available under a grant under this clause shall only be used by the State to provide HIV/AIDS−related medications. The State shall coordinate the use of such amounts with the amounts otherwise provided under section 300ff−26(a) of this title in order to maximize drug coverage. (V) Funding For the purpose of making grants under this clause, the Secretary shall each fiscal year reserve 3 percent of the amount referred to in clause (i) with respect to section 300ff−26 of this title, subject to subclause (VI). (VI) Limitation In reserving amounts under subclause (V) and making grants under this clause for a fiscal year, the Secretary shall ensure for each State that the total of the grant under section 300ff−21 of this title for the State for the fiscal year and the grant under clause (i) for the State for the fiscal year is not less than such total for the State for the preceding fiscal year. (3) Definitions As used in this subsection − (A) the term "State" means each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, and Guam; and (B) the term "territory of the United States" means,(!2)
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American Samoa, the Commonwealth of the Northern Mariana Islands, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau, and only for purposes of paragraph (1) the Commonwealth of Puerto Rico. (b) Allocation of assistance by States (1) Repealed. Pub. L. 104−146, Sec. 3(c)(5)(A), May 20, 1996, 110 Stat. 1355 (2) Allowances Prior to allocating assistance under this subsection, a State shall consider the unmet needs of those areas that have not received financial assistance under part A of this subchapter. (3) Planning and evaluations Subject to paragraph (5) and except as provided in paragraph (6), a State may not use more than 10 percent of amounts received under a grant awarded under this part for planning and evaluation activities. (4) Administration (A) In general Subject to paragraph (5) and except as provided in paragraph (6), a State may not use more than 10 percent of amounts received under a grant awarded under this part for administration. In the case of entities and subcontractors to which the State allocates amounts received by the State under the grant (including consortia under section 300ff−23 of this title), the State shall ensure that, of the aggregate amount so allocated, the total of the expenditures by such entities for
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administrative expenses does not exceed 10 percent (without regard to whether particular entities expend more than 10 percent for such expenses). (B) Administrative activities For the purposes of subparagraph (A), amounts may be used for administrative activities that include routine grant administration and monitoring activities. (C) Subcontractor administrative costs For the purposes of this paragraph, subcontractor administrative activities include − (i) usual and recognized overhead, including established indirect rates for agencies; (ii) management oversight of specific programs funded under this subchapter; and (iii) other types of program support such as quality assurance, quality control, and related activities. (5) Limitation on use of funds Except as provided in paragraph (6), a State may not use more than a total of 15 percent of amounts received under a grant awarded under this part for the purposes described in paragraphs (3) and (4). (6) Exception With respect to a State that receives the minimum allotment under subsection (a)(1) of this section for a fiscal year, such State, from the amounts received under a grant awarded under this part for such fiscal year for the activities described in
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paragraphs (3) and (4), may, notwithstanding paragraphs (3), (4), and (5), use not more than that amount required to support one full−time−equivalent employee. (7) Construction A State may not use amounts received under a grant awarded under this part to purchase or improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or to make cash payments to intended recipients of services. (c) Expedited distribution (1) In general Not less than 75 percent of the amounts received under a grant awarded to a State under this part shall be obligated to specific programs and projects and made available for expenditure not later than − (A) in the case of the first fiscal year for which amounts are received, 150 days after the receipt of such amounts by the State; and (B) in the case of succeeding fiscal years, 120 days after the receipt of such amounts by the State. (2) Public comment Within the time periods referred to in paragraph (1), the State shall invite and receive public comment concerning methods for the utilization of such amounts. (d) Reallocation Any amounts appropriated in any fiscal year and made available to
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a State under this part that have not been obligated as described in subsection (d) (!3) of this section shall be repaid to the Secretary and reallotted to other States in proportion to the original grants made to such States. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2618, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 595; amended Pub. L. 102−531, title III, Sec. 312(d)(30), Oct. 27, 1992, 106 Stat. 3506; Pub. L. 104−146, Secs. 3(c)(5), (g)(2), 5, 6(c)(3), May 20, 1996, 110 Stat. 1355, 1363, 1365, 1368; Pub. L. 105−392, title IV, Sec. 417, Nov. 13, 1998, 112 Stat. 3591; Pub. L. 106−345, title II, Sec. 206, Oct. 20, 2000, 114 Stat. 1334.) −REFTEXT− REFERENCES IN TEXT Subsection (d) of this section, referred to in subsec. (d), was redesignated subsection (c) by Pub. L. 106−345, title II, Sec. 206(a)(1), Oct. 20, 2000, 114 Stat. 1334. −MISC1− AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−345, Sec. 206(a)(1), redesignated subsec. (b) as (a). Subsec. (a)(1)(A)(i). Pub. L. 106−345, Sec. 206(a)(2), substituted "$200,000" for "$100,000" in subcl. (I) and "$500,000" for "$250,000" in subcl. (II). Subsec. (a)(1)(A)(ii). Pub. L. 106−345, Sec. 206(c)(1), inserted "and then, as applicable, increased under paragraph (2)(H)" before
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semicolon. Subsec. (a)(1)(B). Pub. L. 106−345, Sec. 206(d), inserted "the greater of $50,000 or" after "shall be". Subsec. (a)(2)(A)(i). Pub. L. 106−345, Sec. 206(c)(2)(A), substituted "subparagraphs (H) and (I)" for "subparagraph (H)". Subsec. (a)(2)(D)(i). Pub. L. 106−345, Sec. 206(b)(1), inserted before semicolon ", except that (subject to subparagraph (E)), for grants made pursuant to this paragraph or section 300ff−30 of this title for fiscal year 2005 and subsequent fiscal years, the cases counted for each 12−month period beginning on or after July 1, 2004, shall be cases of HIV disease (as reported to and confirmed by such Director) rather than cases of acquired immune deficiency syndrome". Subsec. (a)(2)(E) to (G). Pub. L. 106−345, Sec. 206(b)(2), (3), added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively. Former subpar. (G) redesignated (H). Subsec. (a)(2)(H). Pub. L. 106−345, Sec. 206(c)(2)(B), amended heading and text of subpar. (H) generally. Prior to amendment, text related to limitations on the amount of a grant awarded for fiscal years 1996 to 2000 to a State or territory under this part in relation to the amount received by the State or territory for fiscal year 1995. Pub. L. 106−345, Sec. 206(b)(2), redesignated subpar. (G) as (H). Former subpar. (H) redesignated (I). Subsec. (a)(2)(I). Pub. L. 106−345, Sec. 206(e), reenacted heading without change, designated existing provisions as cl. (i),
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inserted cl. (i) heading, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, in subcl. (I) inserted ", less the percentage reserved under clause (ii)(V)" before semicolon, and added cl. (ii). Pub. L. 106−345, Sec. 206(b)(2), redesignated subpar. (H) as (I). Subsec. (a)(3)(B). Pub. L. 106−345, Sec. 206(f), substituted "the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau, and only for purposes of paragraph (1) the Commonwealth of Puerto Rico" for "and the Republic of the Marshall Islands". Subsecs. (b) to (e). Pub. L. 106−345, Sec. 206(a)(1), redesignated subsecs. (c) to (e) as (b) to (d), respectively. 1998 − Subsec. (b)(3)(A). Pub. L. 105−392, Sec. 417(1), substituted ", the Commonwealth of Puerto Rico, the Virgin Islands, and Guam" for "and the Commonwealth of Puerto Rico". Subsec. (b)(3)(B). Pub. L. 105−392, Sec. 417(2), struck out "the Virgin Islands, Guam" after "means". 1996 − Subsec. (a). Pub. L. 104−146, Sec. 3(g)(2), struck out subsec. (a) which related to special projects of national significance. Subsec. (a)(1). Pub. L. 104−146, Sec. 6(c)(3)(A), which directed amendment of subsec. (a)(1) by substituting "section 300ff−77" for "section 300ff−30", could not be executed because of the repeal of subsec. (a) by Pub. L. 104−146, Sec. 3(g)(2). See above. Subsec. (b)(1). Pub. L. 104−146, Sec. 6(c)(3)(B), which directed amendment of subsec. (b)(1) by substituting "section 300ff−77 of
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this title" for "section 300ff−30 of this title", could not be executed because the words "section 300ff−30 of this title" did not appear subsequent to the general amendment of subsec. (b)(1) by Pub. L. 104−146, Sec. 5. See below. Pub. L. 104−146, Sec. 5, amended heading and text of par. (1) generally. Prior to amendment, text read as follows: "Subject to the extent of amounts made available under section 300ff−30 of this title, the amount of a grant to be made under this part for − "(A) each of the several States and the District of Columbia for a fiscal year shall be the greater of − "(i) $100,000, and "(ii) an amount determined under paragraph (2); and "(B) each territory of the United States, as defined in paragraph 3, shall be an amount determined under paragraph (2)." Subsec. (b)(2). Pub. L. 104−146, Sec. 5, amended par. (2) generally, substituting subpars. (A) to (H) for former subpars. (A) and (B) relating to determination of amount of allotments. Subsec. (c)(1). Pub. L. 104−146, Sec. 3(c)(5)(A), struck out heading and text of par. (1). Text read as follows: "In a State that has reported 1 percent or more of all AIDS cases reported to and confirmed by the Centers for Disease Control and Prevention in all States, not less than 50 percent of the amount received by the State under a grant awarded under this part shall be utilized for the creation and operation of community−based comprehensive care consortia under section 300ff−23 of this title, in those areas within the State in which the largest number of individuals with
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HIV disease reside." Subsec. (c)(3), (4). Pub. L. 104−146, Sec. 3(c)(5)(B), amended pars. (3) and (4) generally. Prior to amendment, pars. (3) and (4) read as follows: "(3) Planning and evaluations. − A State may not use in excess of 5 percent of amounts received under a grant awarded under this part for planning and evaluation activities. "(4) Administration. − A State may not use in excess of 5 percent of amounts received under a grant awarded under this part for administration, accounting, reporting, and program oversight functions." Subsec. (c)(5) to (7). Pub. L. 104−146, Sec. 3(c)(5)(C), (D), added pars. (5) and (6) and redesignated former par. (5) as (7). 1992 − Subsec. (c)(1). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by sections 3(c)(5), (g)(2) and 6(c)(3)(A) of Pub. L. 104−146 effective Oct. 1, 1996, and amendment by sections 5 and 6(c)(3)(B) of Pub. L. 104−146 effective May 20, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−22, 300ff−30, 300ff−38 of this title. −FOOTNOTE−
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(!1) So in original. Probably should be " 'non−EMA". (!2) So in original. The comma probably should not appear. (!3) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−29 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−29. Technical assistance −STATUTE− The Secretary shall provide technical assistance in administering and coordinating the activities authorized under section 300ff−22 of this title, including technical assistance for the development and implementation of statewide coordinated statements of need. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2619, as added Pub. L. 101−381, title II, Sec. 201, Aug. 18, 1990, 104 Stat. 597; amended Pub. L. 104−146, Sec. 3(c)(6), May 20, 1996, 110 Stat. 1356.) −MISC1− AMENDMENTS 1996 − Pub. L. 104−146 substituted "shall" for "may" and inserted
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", including technical assistance for the development and implementation of statewide coordinated statements of need" before period at end. EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, and amendment by section 6(c)(1)(A) of Pub. L. 104−146 effective May 20, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−30 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−30. Supplemental grants −STATUTE− (a) In general The Secretary shall award supplemental grants to States determined to be eligible under subsection (b) of this section to enable such States to provide comprehensive services of the type described in section 300ff−22(a) of this title to supplement the services otherwise provided by the State under a grant under this
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subpart in emerging communities within the State that are not eligible to receive grants under part A of this subchapter. (b) Eligibility To be eligible to receive a supplemental grant under subsection (a) of this section, a State shall − (1) be eligible to receive a grant under this subpart; (2) demonstrate the existence in the State of an emerging community as defined in subsection (d)(1) of this section; and (3) submit the information described in subsection (c) of this section. (c) Reporting requirements A State that desires a grant under this section shall, as part of the State application submitted under section 300ff−27 of this title, submit a detailed description of the manner in which the State will use amounts received under the grant and of the severity of need. Such description shall include − (1) a report concerning the dissemination of supplemental funds under this section and the plan for the utilization of such funds in the emerging community; (2) a demonstration of the existing commitment of local resources, both financial and in−kind; (3) a demonstration that the State will maintain HIV−related activities at a level that is equal to not less than the level of such activities in the State for the 1−year period preceding the fiscal year for which the State is applying to receive a grant under this part;
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(4) a demonstration of the ability of the State to utilize such supplemental financial resources in a manner that is immediately responsive and cost effective; (5) a demonstration that the resources will be allocated in accordance with the local demographic incidence of AIDS including appropriate allocations for services for infants, children, women, and families with HIV disease; (6) a demonstration of the inclusiveness of the planning process, with particular emphasis on affected communities and individuals with HIV disease; and (7) a demonstration of the manner in which the proposed services are consistent with local needs assessments and the statewide coordinated statement of need. (d) Definition of emerging community In this section, the term "emerging community" means a metropolitan area − (1) that is not eligible for a grant under part A of this subchapter; and (2) for which there has been reported to the Director of the Centers for Disease Control and Prevention a cumulative total of between 500 and 1,999 cases of acquired immune deficiency syndrome for the most recent period of 5 calendar years for which such data are available (except that, for fiscal year 2005 and subsequent fiscal years, cases of HIV disease shall be counted rather than cases of acquired immune deficiency syndrome if cases of HIV disease are being counted for purposes of section
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300ff−28(a)(2)(D)(i) of this title). (e) Funding (1) In general Subject to paragraph (2), with respect to each fiscal year beginning with fiscal year 2001, the Secretary, to carry out this section, shall utilize − (A) the greater of − (i) 25 percent of the amount appropriated under section 300ff−77 of this title to carry out this part, excluding the amount appropriated under section 300ff−28(a)(2)(I) of this title, for such fiscal year that is in excess of the amount appropriated to carry out this part in the fiscal year preceding the fiscal year involved; or (ii) $5,000,000, to provide funds to States for use in emerging communities with at least 1,000, but less than 2,000, cases of AIDS as reported to and confirmed by the Director of the Centers for Disease Control and Prevention for the five year period preceding the year for which the grant is being awarded; and (B) the greater of − (i) 25 percent of the amount appropriated under section 300ff−77 of this title to carry out this part, excluding the amount appropriated under section 300ff−28(a)(2)(I) of this title, for such fiscal year that is in excess of the amount appropriated to carry out such part in the fiscal year preceding the fiscal year involved; or
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(ii) $5,000,000, to provide funds to States for use in emerging communities with at least 500, but less than 1,000, cases of AIDS reported to and confirmed by the Director of the Centers for Disease Control and Prevention for the five year period preceding the year for which the grant is being awarded. (2) Trigger of funding This section shall be effective only for fiscal years beginning in the first fiscal year in which the amount appropriated under section 300ff−77 of this title to carry out this part, excluding the amount appropriated under section 300ff−28(a)(2)(I) of this title, exceeds by at least $20,000,000 the amount appropriated under section 300ff−77 of this title to carry out this part in fiscal year 2000, excluding the amount appropriated under section 300ff−28(a)(2)(I) of this title. (3) Minimum amount in future years Beginning with the first fiscal year in which amounts provided for emerging communities under paragraph (1)(A) equals $5,000,000 and under paragraph (1)(B) equals $5,000,000, the Secretary shall ensure that amounts made available under this section for the types of emerging communities described in each such paragraph in subsequent fiscal years is at least $5,000,000. (4) Distribution Grants under this section for emerging communities shall be formula grants. There shall be two categories of such formula grants, as follows:
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(A) One category of such grants shall be for emerging communities for which the cumulative total of cases for purposes of subsection (d)(2) of this section is 999 or fewer cases. The grant made to such an emerging community for a fiscal year shall be the product of − (i) an amount equal to 50 percent of the amount available pursuant to this subsection for the fiscal year involved; and (ii) a percentage equal to the ratio constituted by the number of cases for such emerging community for the fiscal year over the aggregate number of such cases for such year for all emerging communities to which this subparagraph applies. (B) The other category of formula grants shall be for emerging communities for which the cumulative total of cases for purposes of subsection (d)(2) of this section is 1,000 or more cases. The grant made to such an emerging community for a fiscal year shall be the product of − (i) an amount equal to 50 percent of the amount available pursuant to this subsection for the fiscal year involved; and (ii) a percentage equal to the ratio constituted by the number of cases for such community for the fiscal year over the aggregate number of such cases for the fiscal year for all emerging communities to which this subparagraph applies. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2620, as added Pub. L. 106−345, title II, Sec. 207(2), Oct. 20, 2000, 114 Stat. 1337.)
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−MISC1− PRIOR PROVISIONS A prior section 300ff−30, act July 1, 1944, ch. 373, title XXVI, Sec. 2620, as added Aug. 18, 1990, Pub. L. 101−381, title II, Sec. 201, 104 Stat. 597, authorized appropriations for fiscal years 1991 through 1995, prior to repeal by Pub. L. 104−146, Secs. 6(b), 13, May 20, 1996, 110 Stat. 1367, 1374, effective Oct. 1, 1996. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ff−28 of this title. −End− −CITE− 42 USC Sec. 300ff−31 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart i − general grant provisions −HEAD− Sec. 300ff−31. Repealed. Pub. L. 106−345, title II, Sec. 207(1), Oct. 20, 2000, 114 Stat. 1337 −MISC1− Section, act July 1, 1944, ch. 373, title XXVI, Sec. 2621, as added Pub. L. 104−146, Sec. 3(c)(7), May 20, 1996, 110 Stat. 1356, related to coordination of planning and implementation of Federal
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HIV programs to facilitate the local development of a complete continuum of HIV−related services for individuals with HIV disease and those at risk of such disease and required a biennial report to Congress on coordination efforts. −End− −CITE− 42 USC subpart ii − provisions concerning pregnancy and perinatal transmission of hiv 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart ii − provisions concerning pregnancy and perinatal transmission of hiv −HEAD− SUBPART II − PROVISIONS CONCERNING PREGNANCY AND PERINATAL TRANSMISSION OF HIV −End− −CITE− 42 USC Sec. 300ff−33 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program
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subpart ii − provisions concerning pregnancy and perinatal transmission of hiv −HEAD− Sec. 300ff−33. CDC guidelines for pregnant women −STATUTE− (a) Requirement Notwithstanding any other provision of law, a State shall, not later than 120 days after May 20, 1996, certify to the Secretary that such State has in effect regulations or measures to adopt the guidelines issued by the Centers for Disease Control and Prevention concerning recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women. (b) Noncompliance If a State does not provide the certification required under subsection (a) of this section within the 120−day period described in such subsection, such State shall not be eligible to receive assistance for HIV counseling and testing under this section until such certification is provided. (c) Additional funds regarding women and infants (1) In general If a State provides the certification required in subsection (a) of this section and is receiving funds under this part for a fiscal year, the Secretary may (from the amounts available pursuant to paragraph (2)) make a grant to the State for the fiscal year for the following purposes: (A) Making available to pregnant women appropriate counseling
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on HIV disease. (B) Making available outreach efforts to pregnant women at high risk of HIV who are not currently receiving prenatal care. (C) Making available to such women voluntary HIV testing for such disease. (D) Offsetting other State costs associated with the implementation of this section and subsections (a) and (b) of section 300ff−34 of this title. (E) Offsetting State costs associated with the implementation of mandatory newborn testing in accordance with this subchapter or at an earlier date than is required by this subchapter. (F) Making available to pregnant women with HIV disease, and to the infants of women with such disease, treatment services for such disease in accordance with applicable recommendations of the Secretary. (2) Funding (A) Authorization of appropriations For the purpose of carrying out this subsection, there are authorized to be appropriated $30,000,000 for each of the fiscal years 2001 through 2005. Amounts made available under section 300ff−77 of this title for carrying out this part are not available for carrying out this section unless otherwise authorized. (B) Allocations for certain States (i) In general Of the amounts appropriated under subparagraph (A) for a
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fiscal year in excess of $10,000,000 − (I) the Secretary shall reserve the applicable percentage under clause (iv) for making grants under paragraph (1) both to States described in clause (ii) and States described in clause (iii); and (II) the Secretary shall reserve the remaining amounts for other States, taking into consideration the factors described in subparagraph (C)(iii), except that this subclause does not apply to any State that for the fiscal year involved is receiving amounts pursuant to subclause (I). (ii) Required testing of newborns For purposes of clause (i)(I), the States described in this clause are States that under law (including under regulations or the discretion of State officials) have − (I) a requirement that all newborn infants born in the State be tested for HIV disease and that the biological mother of each such infant, and the legal guardian of the infant (if other than the biological mother), be informed of the results of the testing; or (II) a requirement that newborn infants born in the State be tested for HIV disease in circumstances in which the attending obstetrician for the birth does not know the HIV status of the mother of the infant, and that the biological mother of each such infant, and the legal guardian of the infant (if other than the biological mother), be informed
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of the results of the testing. (iii) Most significant reduction in cases of perinatal transmission For purposes of clause (i)(I), the States described in this clause are the following (exclusive of States described in clause (ii)), as applicable: (I) For fiscal years 2001 and 2002, the two States that, relative to other States, have the most significant reduction in the rate of new cases of the perinatal transmission of HIV (as indicated by the number of such cases reported to the Director of the Centers for Disease Control and Prevention for the most recent periods for which the data are available). (II) For fiscal years 2003 and 2004, the three States that have the most significant such reduction. (III) For fiscal year 2005, the four States that have the most significant such reduction. (iv) Applicable percentage For purposes of clause (i), the applicable amount for a fiscal year is as follows: (I) For fiscal year 2001, 33 percent. (II) For fiscal year 2002, 50 percent. (III) For fiscal year 2003, 67 percent. (IV) For fiscal year 2004, 75 percent. (V) For fiscal year 2005, 75 percent. (C) Certain provisions
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With respect to grants under paragraph (1) that are made with amounts reserved under subparagraph (B) of this paragraph: (i) Such a grant may not be made in an amount exceeding $4,000,000. (ii) If pursuant to clause (i) or pursuant to an insufficient number of qualifying applications for such grants (or both), the full amount reserved under subparagraph (B) for a fiscal year is not obligated, the requirement under such subparagraph to reserve amounts ceases to apply. (iii) In the case of a State that meets the conditions to receive amounts reserved under subparagraph (B)(i)(II), the Secretary shall in making grants consider the following factors: (I) The extent of the reduction in the rate of new cases of the perinatal transmission of HIV. (II) The extent of the reduction in the rate of new cases of perinatal cases of acquired immune deficiency syndrome. (III) The overall incidence of cases of infection with HIV among women of childbearing age. (IV) The overall incidence of cases of acquired immune deficiency syndrome among women of childbearing age. (V) The higher acceptance rate of HIV testing of pregnant women. (VI) The extent to which women and children with HIV disease are receiving HIV−related health services. (VII) The extent to which HIV−exposed children are
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receiving health services appropriate to such exposure. (3) Priority In awarding grants under this subsection the Secretary shall give priority to States that have the greatest proportion of HIV seroprevalance among child bearing women using the most recent data available as determined by the Centers for Disease Control and Prevention. (4) Maintenance of effort A condition for the receipt of a grant under paragraph (1) is that the State involved agree that the grant will be used to supplement and not supplant other funds available to the State to carry out the purposes of the grant. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2625, as added Pub. L. 104−146, Sec. 7(b)(3), May 20, 1996, 110 Stat. 1369; amended Pub. L. 106−345, title II, Sec. 212(a), Oct. 20, 2000, 114 Stat. 1339.) −MISC1− AMENDMENTS 2000 − Subsec. (c)(1)(F). Pub. L. 106−345, Sec. 212(a)(1), added subpar. (F). Subsec. (c)(2). Pub. L. 106−345, Sec. 212(a)(2), amended heading and text of par. (2) generally. Prior to amendment, text read as follows: "For purposes of carrying out this subsection, there are authorized to be appropriated $10,000,000 for each of the fiscal years 1996 through 2000. Amounts made available under section 300ff−77 of this title for carrying out this part are not available
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for carrying out this section unless otherwise authorized." Subsec. (c)(4). Pub. L. 106−345, Sec. 212(a)(3), added par. (4). EFFECTIVE DATE Section effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as an Effective Date of 1996 Amendment note under section 300ff−11 of this title. PERINATAL TRANSMISSION OF HIV DISEASE; CONGRESSIONAL FINDINGS Section 7(a) of Pub. L. 104−146 provided that: "The Congress finds as follows: "(1) Research studies and statewide clinical experiences have demonstrated that administration of anti−retroviral medication during pregnancy can significantly reduce the transmission of the human immunodeficiency virus (commonly known as HIV) from an infected mother to her baby. "(2) The Centers for Disease Control and Prevention have recommended that all pregnant women receive HIV counseling; voluntary, confidential HIV testing; and appropriate medical treatment (including anti−retroviral therapy) and support services. "(3) The provision of such testing without access to such counseling, treatment, and services will not improve the health of the woman or the child. "(4) The provision of such counseling, testing, treatment, and services can reduce the number of pediatric cases of acquired immune deficiency syndrome, can improve access to and provision of medical care for the woman, and can provide opportunities for
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counseling to reduce transmission among adults, and from mother to child. "(5) The provision of such counseling, testing, treatment, and services can reduce the overall cost of pediatric cases of acquired immune deficiency syndrome. "(6) The cancellation or limitation of health insurance or other health coverage on the basis of HIV status should be impermissible under applicable law. Such cancellation or limitation could result in disincentives for appropriate counseling, testing, treatment, and services. "(7) For the reasons specified in paragraphs (1) through (6) − "(A) routine HIV counseling and voluntary testing of pregnant women should become the standard of care; and "(B) the relevant medical organizations as well as public health officials should issue guidelines making such counseling and testing the standard of care." −End− −CITE− 42 USC Sec. 300ff−34 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart ii − provisions concerning pregnancy and perinatal transmission of hiv
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−HEAD− Sec. 300ff−34. Perinatal transmission of HIV disease; contingent requirement regarding State grants under this part −STATUTE− (a) Annual determination of reported cases A State shall annually determine the rate of reported cases of AIDS as a result of perinatal transmission among residents of the State. (b) Causes of perinatal transmission In determining the rate under subsection (a) of this section, a State shall also determine the possible causes of perinatal transmission. Such causes may include − (1) the inadequate provision within the State of prenatal counseling and testing in accordance with the guidelines issued by the Centers for Disease Control and Prevention; (2) the inadequate provision or utilization within the State of appropriate therapy or failure of such therapy to reduce perinatal transmission of HIV, including − (A) that therapy is not available, accessible or offered to mothers; or (B) that available therapy is offered but not accepted by mothers; or (3) other factors (which may include the lack of prenatal care) determined relevant by the State. (c) CDC reporting system Not later than 4 months after May 20, 1996, the Director of the
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Centers for Disease Control and Prevention shall develop and implement a system to be used by States to comply with the requirements of subsections (a) and (b) of this section. The Director shall issue guidelines to ensure that the data collected is statistically valid. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2626, as added Pub. L. 104−146, Sec. 7(b)(3), May 20, 1996, 110 Stat. 1369; amended Pub. L. 104−166, Sec. 5(1), July 29, 1996, 110 Stat. 1449; Pub. L. 106−345, title II, Sec. 211(1), Oct. 20, 2000, 114 Stat. 1339.) −MISC1− AMENDMENTS 2000 − Subsecs. (d) to (f). Pub. L. 106−345 struck out subsecs. (d) to (f), which related, respectively, to determination by Secretary, contingent applicability, and limitation regarding availability of funds. 1996 − Subsec. (d). Pub. L. 104−166, Sec. 5(1)(A), substituted "(1) through (4)" for "(1) through (5)". Subsec. (f). Pub. L. 104−166, Sec. 5(1)(B), substituted "(1) through (4)" for "(1) through (5)" in introductory provisions. EFFECTIVE DATE Section effective May 20, 1996, see section 13(b) of Pub. L. 104−146, set out as an Effective Date of 1996 Amendment note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS
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This section is referred to in sections 300ff−21, 300ff−33 of this title. −End− −CITE− 42 USC Secs. 300ff−35, 300ff−36 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart ii − provisions concerning pregnancy and perinatal transmission of hiv −HEAD− Secs. 300ff−35, 300ff−36. Repealed. Pub. L. 106−345, title II, Sec. 211(2), Oct. 20, 2000, 114 Stat. 1339 −MISC1− Section 300ff−35, act July 1, 1944, ch. 373, title XXVI, Sec. 2627, as added Pub. L. 104−146, Sec. 7(b)(3), May 20, 1996, 110 Stat. 1371, related to testing of pregnant women and newborn infants for HIV disease. Section 300ff−36, act July 1, 1944, ch. 373, title XXVI, Sec. 2628, as added Pub. L. 104−146, Sec. 7(b)(3), May 20, 1996, 110 Stat. 1372, related to report to Congress by Institute of Medicine. −End− −CITE− 42 USC Sec. 300ff−37 01/06/03
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−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart ii − provisions concerning pregnancy and perinatal transmission of hiv −HEAD− Sec. 300ff−37. State HIV testing programs established prior to or after May 20, 1996 −STATUTE− Nothing in this subpart shall be construed to disqualify a State from receiving grants under this subchapter if such State has established at any time prior to or after May 20, 1996, a program of mandatory HIV testing. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2627, formerly Sec. 2629, as added Pub. L. 104−146, Sec. 7(b)(3), May 20, 1996, 110 Stat. 1372; renumbered Sec. 2627, Pub. L. 106−345, title II, Sec. 211(3), Oct. 20, 2000, 114 Stat. 1339.) −MISC1− PRIOR PROVISIONS A prior section 2627 of act July 1, 1944, was classified to section 300ff−35 of this title prior to repeal by Pub. L. 106−345. EFFECTIVE DATE Section effective Oct. 1, 1996, see section 13 of Pub. L.
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104−146, set out as an Effective Date of 1996 Amendment note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−37a 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart ii − provisions concerning pregnancy and perinatal transmission of hiv −HEAD− Sec. 300ff−37a. Recommendations for reducing incidence of perinatal transmission −STATUTE− (a) Study by Institute of Medicine (1) In general The Secretary shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study to provide the following: (A) For the most recent fiscal year for which the information is available, a determination of the number of newborn infants with HIV born in the United States with respect to whom the attending obstetrician for the birth did not know the HIV status of the mother.
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(B) A determination for each State of any barriers, including legal barriers, that prevent or discourage an obstetrician from making it a routine practice to offer pregnant women an HIV test and a routine practice to test newborn infants for HIV disease in circumstances in which the obstetrician does not know the HIV status of the mother of the infant. (C) Recommendations for each State for reducing the incidence of cases of the perinatal transmission of HIV, including recommendations on removing the barriers identified under subparagraph (B). If such Institute declines to conduct the study, the Secretary shall enter into an agreement with another appropriate public or nonprofit private entity to conduct the study. (2) Report The Secretary shall ensure that, not later than 18 months after the effective date of this section, the study required in paragraph (1) is completed and a report describing the findings made in the study is submitted to the appropriate committees of the Congress, the Secretary, and the chief public health official of each of the States. (b) Progress toward recommendations In fiscal year 2004, the Secretary shall collect information from the States describing the actions taken by the States toward meeting the recommendations specified for the States under subsection (a)(1)(C) of this section. (c) Submission of reports to Congress
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The Secretary shall submit to the appropriate committees of the Congress reports describing the information collected under subsection (b) of this section. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2628, as added Pub. L. 106−345, title II, Sec. 213, Oct. 20, 2000, 114 Stat. 1342.) −REFTEXT− REFERENCES IN TEXT The effective date of this section, referred to in subsec. (a)(2), is Oct. 20, 2000. See section 601 of Pub. L. 106−345, set out as an Effective Date of 2000 Amendment note under section 300ff−12 of this title. −MISC1− PRIOR PROVISIONS A prior section 2628 of act July 1, 1944, was classified to section 300ff−36 of this title prior to repeal by Pub. L. 106−345. −End− −CITE− 42 USC subpart iii − certain partner notification programs 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart iii − certain partner notification programs
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−HEAD− SUBPART III − CERTAIN PARTNER NOTIFICATION PROGRAMS −End− −CITE− 42 USC Sec. 300ff−38 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part B − Care Grant Program subpart iii − certain partner notification programs −HEAD− Sec. 300ff−38. Grants for partner notification programs −STATUTE− (a) In general In the case of States whose laws or regulations are in accordance with subsection (b) of this section, the Secretary, subject to subsection (c)(2) of this section, may make grants to the States for carrying out programs to provide partner counseling and referral services. (b) Description of compliant State programs For purposes of subsection (a) of this section, the laws or regulations of a State are in accordance with this subsection if under such laws or regulations (including programs carried out pursuant to the discretion of State officials) the following policies are in effect:
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(1) The State requires that the public health officer of the State carry out a program of partner notification to inform partners of individuals with HIV disease that the partners may have been exposed to the disease. (2)(A) In the case of a health entity that provides for the performance on an individual of a test for HIV disease, or that treats the individual for the disease, the State requires, subject to subparagraph (B), that the entity confidentially report the positive test results to the State public health officer in a manner recommended and approved by the Director of the Centers for Disease Control and Prevention, together with such additional information as may be necessary for carrying out such program. (B) The State may provide that the requirement of subparagraph (A) does not apply to the testing of an individual for HIV disease if the individual underwent the testing through a program designed to perform the test and provide the results to the individual without the individual disclosing his or her identity to the program. This subparagraph may not be construed as affecting the requirement of subparagraph (A) with respect to a health entity that treats an individual for HIV disease. (3) The program under paragraph (1) is carried out in accordance with the following: (A) Partners are provided with an appropriate opportunity to learn that the partners have been exposed to HIV disease, subject to subparagraph (B).
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(B) The State does not inform partners of the identity of the infected individuals involved. (C) Counseling and testing for HIV disease are made available to the partners and to infected individuals, and such counseling includes information on modes of transmission for the disease, including information on prenatal and perinatal transmission and preventing transmission. (D) Counseling of infected individuals and their partners includes the provision of information regarding therapeutic measures for preventing and treating the deterioration of the immune system and conditions arising from the disease, and the provision of other prevention−related information. (E) Referrals for appropriate services are provided to partners and infected individuals, including referrals for support services and legal aid. (F) Notifications under subparagraph (A) are provided in person, unless doing so is an unreasonable burden on the State. (G) There is no criminal or civil penalty on, or civil liability for, an infected individual if the individual chooses not to identify the partners of the individual, or the individual does not otherwise cooperate with such program. (H) The failure of the State to notify partners is not a basis for the civil liability of any health entity who under the program reported to the State the identity of the infected individual involved. (I) The State provides that the provisions of the program may
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not be construed as prohibiting the State from providing a notification under subparagraph (A) without the consent of the infected individual involved. (4) The State annually reports to the Director of the Centers for Disease Control and Prevention the number of individuals from whom the names of partners have been sought under the program under paragraph (1), the number of such individuals who provided the names of partners, and the number of partners so named who were notified under the program. (5) The State cooperates with such Director in carrying out a national program of partner notification, including the sharing of information between the public health officers of the States. (c) Reporting system for cases of HIV disease; preference in making grants In making grants under subsection (a) of this section, the Secretary shall give preference to States whose reporting systems for cases of HIV disease produce data on such cases that is sufficiently accurate and reliable for use for purposes of section 300ff−28(a)(2)(D)(i) of this title. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $30,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 through 2005. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2631, as added Pub. L.
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106−345, title II, Sec. 221, Oct. 20, 2000, 114 Stat. 1343.) −End− −CITE− 42 USC Part C − Early Intervention Services 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services −HEAD− PART C − EARLY INTERVENTION SERVICES −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in sections 300ff−12, 300ff−101 of this title. −End− −CITE− 42 USC Secs. 300ff−41 to 300ff−50 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services −HEAD− Secs. 300ff−41 to 300ff−50. Repealed. Pub. L. 106−345, title III, Sec. 301(a), Oct. 20, 2000, 114 Stat. 1345
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−MISC1− Section 300ff−41, act July 1, 1944, ch. 373, title XXVI, Sec. 2641, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 597; amended Pub. L. 102−531, title III, Sec. 312(d)(31), Oct. 27, 1992, 106 Stat. 3506, established program of formula grants to States. Section 300ff−42, act July 1, 1944, ch. 373, title XXVI, Sec. 2642, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 599, related to provision of services through medicaid providers. Section 300ff−43, act July 1, 1944, ch. 373, title XXVI, Sec. 2643, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 600; amended Pub. L. 102−531, title III, Sec. 312(d)(32), Oct. 27, 1992, 106 Stat. 3506, related to requirement of matching funds. Section 300ff−44, act July 1, 1944, ch. 373, title XXVI, Sec. 2644, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 601, related to the offering and encouraging of early intervention services. Section 300ff−45, act July 1, 1944, ch. 373, title XXVI, Sec. 2645, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 602, related to notification of certain individuals receiving blood transfusions. Section 300ff−46, act July 1, 1944, ch. 373, title XXVI, Sec. 2646, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 602, related to reporting and partner notification.
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Section 300ff−47, act July 1, 1944, ch. 373, title XXVI, Sec. 2647, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 603; amended Pub. L. 101−502, Sec. 6(c), Nov. 3, 1990, 104 Stat. 1291; Pub. L. 104−146, Sec. 12(c)(4), May 20, 1996, 110 Stat. 1373, related to requirement of State law protection against intentional transmission. Section 300ff−48, act July 1, 1944, ch. 373, title XXVI, Sec. 2648, formerly Pub. L. 100−607, title IX, Sec. 902, Nov. 4, 1988, 102 Stat. 3171; amended Pub. L. 100−690, title II, Sec. 2605(a), Nov. 18, 1988, 102 Stat. 4234; renumbered Sec. 2648 and amended Pub. L. 101−381, title III, Sec. 301(b), Aug. 18, 1990, 104 Stat. 614; Pub. L. 104−146, Sec. 12(c)(5), May 20, 1996, 110 Stat. 1374, related to testing and other early intervention services for State prisoners. Section 300ff−49, act July 1, 1944, ch. 373, title XXVI, Sec. 2649, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 604; amended Pub. L. 101−502, Sec. 6(b), Nov. 3, 1990, 104 Stat. 1290; Pub. L. 102−531, title III, Sec. 312(d)(33), Oct. 27, 1992, 106 Stat. 3506; Pub. L. 104−146, Sec. 12(c)(6), May 20, 1996, 110 Stat. 1374, related to determination of amount of allotments. Section 300ff−49a, act July 1, 1944, ch. 373, title XXVI, Sec. 2649A, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 605, related to miscellaneous prerequisites for the Secretary to make a grant. Section 300ff−50, act July 1, 1944, ch. 373, title XXVI, Sec.
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2650, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 606, authorized appropriations. −End− −CITE− 42 USC subpart i − categorical grants 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart i − categorical grants −HEAD− SUBPART I − CATEGORICAL GRANTS −MISC1− AMENDMENTS Pub. L. 106−345, title III, Sec. 301(b)(1), Oct. 20, 2000, 114 Stat. 1345, redesignated subpart II as subpart I. PRIOR PROVISIONS A prior subpart I, consisting of sections 300ff−41 to 300ff−50, related to formula grants for States, prior to repeal by Pub. L. 106−345, title III, Sec. 301(a), Oct. 20, 2000, 114 Stat. 1345. −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in sections 256b, 300ff−12 of this title. −End−
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−CITE− 42 USC Sec. 300ff−51 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart i − categorical grants −HEAD− Sec. 300ff−51. Establishment of program −STATUTE− (a) In general For the purposes described in subsection (b) of this section, the Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants to public and nonprofit private entities specified in section 300ff−52(a) of this title. (b) Purposes of grants (1) In general The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees to expend the grant for the purposes of providing, on an outpatient basis, each of the early intervention services specified in paragraph (2) with respect to HIV disease, and unless the applicant agrees to expend not less than 50 percent of the grant for such services that are specified in subparagraphs (B) through (E) of such
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paragraph for individuals with HIV disease. (2) Specification of early intervention services The early intervention services referred to in paragraph (1) are − (A) counseling individuals with respect to HIV disease in accordance with section 300ff−62 of this title; (B) testing individuals with respect to such disease, including tests to confirm the presence of the disease, tests to diagnose the extent of the deficiency in the immune system, and tests to provide information on appropriate therapeutic measures for preventing and treating the deterioration of the immune system and for preventing and treating conditions arising from the disease; (C) referrals described in paragraph (3); (D) other clinical and diagnostic services regarding HIV disease, and periodic medical evaluations of individuals with the disease; (E) providing the therapeutic measures described in subparagraph (B). (3) Referrals The services referred to in paragraph (2)(C) are referrals of individuals with HIV disease to appropriate providers of health and support services, including, as appropriate − (A) to entities receiving amounts under part A or B of this subchapter for the provision of such services; (B) to biomedical research facilities of institutions of
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higher education that offer experimental treatment for such disease, or to community−based organizations or other entities that provide such treatment; or (C) to grantees under section 300ff−71 of this title, in the case of a pregnant woman. (4) Requirement of availability of all early intervention services through each grantee (A) In general The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees that each of the early intervention services specified in paragraph (2) will be available through the grantee. With respect to compliance with such agreement, such a grantee may expend the grant to provide the early intervention services directly, and may expend the grant to enter into agreements with public or nonprofit private entities, or private for−profit entities if such entities are the only available provider of quality HIV care in the area, under which the entities provide the services. (B) Other requirements Grantees described in − (i) paragraphs (1), (2), (5), and (6) of section 300ff−52(a) of this title shall use not less than 50 percent of the amount of such a grant to provide the services described in subparagraphs (A), (B), (D), and (E) of paragraph (2) directly and on−site or at sites where other
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primary care services are rendered; and (ii) paragraphs (3) and (4) of section 300ff−52(a) of this title shall ensure the availability of early intervention services through a system of linkages to community−based primary care providers, and to establish mechanisms for the referrals described in paragraph (2)(C), and for follow−up concerning such referrals. (5) Optional services A grantee under subsection (a) of this section − (A) may expend the grant to provide outreach services to individuals who may have HIV disease or may be at risk of the disease, and who may be unaware of the availability and potential benefits of early treatment of the disease, and to provide outreach services to health care professionals who may be unaware of such availability and potential benefits; and (B) may, in the case of individuals who seek early intervention services from the grantee, expend the grant − (i) for case management to provide coordination in the provision of health care services to the individuals and to review the extent of utilization of the services by the individuals; and (ii) to provide assistance to the individuals regarding establishing the eligibility of the individuals for financial assistance and services under Federal, State, or local programs providing for health services, mental health services, social services, or other appropriate services.
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(c) Participation in certain consortium The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees to make reasonable efforts to participate in a consortium established with a grant under section 300ff−22(a)(1) (!1) of this title regarding comprehensive services to individuals with HIV disease, if such a consortium exists in the geographic area with respect to which the applicant is applying to receive such a grant. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2651, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 606; amended Pub. L. 101−557, title IV, Sec. 401(b)(2), Nov. 15, 1990, 104 Stat. 2771; Pub. L. 104−146, Secs. 3(d)(1), 12(c)(7), May 20, 1996, 110 Stat. 1357, 1374.) −REFTEXT− REFERENCES IN TEXT Section 300ff−22 of this title, referred to in subsec. (c), was amended by Pub. L. 104−146, Sec. 3(c)(2)(A)(i), (ii), May 20, 1996, 110 Stat. 1354, and Pub. L. 106−345, title II, Sec. 202(1), Oct. 20, 2000, 114 Stat. 1330, and as so amended, provisions formerly contained in section 300ff−22(a)(1) are now contained in section 300ff−22(a)(2). −MISC1− AMENDMENTS 1996 − Subsec. (b)(1). Pub. L. 104−146, Sec. 3(d)(1)(A), inserted before period ", and unless the applicant agrees to expend not less
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than 50 percent of the grant for such services that are specified in subparagraphs (B) through (E) of such paragraph for individuals with HIV disease". Subsec. (b)(3)(B). Pub. L. 104−146, Sec. 12(c)(7)(A), substituted "facilities" for "facility". Subsec. (b)(4). Pub. L. 104−146, Sec. 3(d)(1)(B), designated existing provisions as subpar. (A) and inserted heading, inserted ", or private for−profit entities if such entities are the only available provider of quality HIV care in the area," after "nonprofit private entities", realigned margin, and added subpar. (B). Subsec. (c). Pub. L. 104−146, Sec. 12(c)(7)(B), substituted "exists" for "exist". 1990 − Subsec. (a). Pub. L. 101−557 substituted "section 300ff−52(a)" for "section 300ff−52(a)(1)". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−14, 300ff−22, 300ff−52, 300ff−53, 300ff−54, 300ff−55, 300ff−61 of this title. −FOOTNOTE− (!1) See References in Text note below. −End−
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−CITE− 42 USC Sec. 300ff−52 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart i − categorical grants −HEAD− Sec. 300ff−52. Minimum qualifications of grantees −STATUTE− (a) In general The entities referred to in section 300ff−51(a) of this title are public entities and nonprofit private entities that are − (1) migrant health centers under section 254b (!1) of this title or community health centers under section 254c (!1) of this title; (2) grantees under section 254b(h) of this title (regarding health services for the homeless); (3) grantees under section 300 of this title (regarding family planning) other than States; (4) comprehensive hemophilia diagnostic and treatment centers; (5) Federally−qualified health centers under section 1905(l)(2)(B) of the Social Security Act [42 U.S.C. 1396d(l)(2)(B)]; or (6) nonprofit private entities that provide comprehensive
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primary care services to populations at risk of HIV disease. (b) Status as medicaid provider (1) In general Subject to paragraph (2), the Secretary may not make a grant under section 300ff−51 of this title for the provision of services described in subsection (b) of such section in a State unless, in the case of any such service that is available pursuant to the State plan approved under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for the State − (A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or (B) the applicant for the grant will enter into an agreement with a public or nonprofit private entity, or a private for−profit entity if such entity is the only available provider of quality HIV care in the area, under which the entity will provide the service, and the entity has entered into such a participation agreement and is qualified to receive such payments. (2) Waiver regarding certain secondary agreements (A) In the case of an entity making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the entity does not, in providing health care services, impose a
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charge or accept reimbursement available from any third−party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program. (B) A determination by the Secretary of whether an entity referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the entity accepts voluntary donations regarding the provision of services to the public. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2652, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 607; amended Pub. L. 101−557, title IV, Sec. 401(b)(3), Nov. 15, 1990, 104 Stat. 2771; Pub. L. 104−146, Sec. 3(d)(2), May 20, 1996, 110 Stat. 1357; Pub. L. 107−251, title VI, Sec. 601(a), Oct. 26, 2002, 116 Stat. 1664.) −REFTEXT− REFERENCES IN TEXT Sections 254b and 254c of this title, referred to in subsec. (a)(1), were in the original references to sections 329 and 330, meaning sections 329 and 330 of act July 1, 1944, which were omitted in the general amendment of subpart I (Sec. 254b et seq.) of part D of subchapter II of this chapter by Pub. L. 104−299, Sec. 2, Oct. 11, 1996, 110 Stat. 3626. Sections 2 and 3(a) of Pub. L. 104−299 enacted new sections 330 and 330A of act July 1, 1944, which are classified, respectively, to sections 254b and 254c of this title.
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The Social Security Act, referred to in subsec. (b)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX of the Social Security Act is classified generally to subchapter XIX (Sec. 1396 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. −MISC1− AMENDMENTS 2002 − Subsec. (a)(2). Pub. L. 107−251 substituted "254b(h)" for "256". 1996 − Subsec. (b)(1)(B). Pub. L. 104−146 inserted ", or a private for−profit entity if such entity is the only available provider of quality HIV care in the area," after "nonprofit private entity". 1990 − Subsec. (a). Pub. L. 101−557 substituted "referred to in section 300ff−51(a) of this title" for "referred to in subsection (b) of this section", redesignated pars. (A) to (F) as (1) to (6), respectively, and substituted "nonprofit private entities that provide" for "a nonprofit private entity that provides" in par. (6). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING, OR HOMELESS HEALTH CENTER CONSIDERED REFERENCE TO HEALTH CENTER
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Reference to community health center, migrant health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104−299, set out as a note under section 254b of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−14, 300ff−15, 300ff−22, 300ff−27, 300ff−51, 300ff−64 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300ff−53 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart i − categorical grants −HEAD− Sec. 300ff−53. Preferences in making grants −STATUTE− (a) In general In making grants under section 300ff−51 of this title, the Secretary shall give preference to any qualified applicant experiencing an increase in the burden of providing services
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regarding HIV disease, as indicated by the factors specified in subsection (b) of this section. (b) Specification of factors (1) In general In the case of the geographic area with respect to which the entity involved is applying for a grant under section 300ff−51 of this title, the factors referred to in subsection (a) of this section, as determined for the period specified in paragraph (2), are − (A) the number of cases of acquired immune deficiency syndrome; (B) the rate of increase in such cases; (C) the lack of availability of early intervention services; (D) the number of other cases of sexually transmitted diseases, and the number of cases of tuberculosis and of drug abuse; (E) the rate of increase in each of the cases specified in subparagraph (D); (F) the lack of availability of primary health services from providers other than such applicant; and (G) the distance between such area and the nearest community that has an adequate level of availability of appropriate HIV−related services, and the length of time required to travel such distance. (2) Relevant period of time The period referred to in paragraph (1) is the 2−year period
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preceding the fiscal year for which the entity involved is applying to receive a grant under section 300ff−51 of this title. (c) Equitable allocations In providing preferences for purposes of subsection (b) of this section, the Secretary shall equitably allocate the preferences among urban and rural areas. (d) Certain areas Of the applicants who qualify for preference under this section − (1) the Secretary shall give preference to applicants that will expend the grant under section 300ff−51 of this title to provide early intervention under such section in rural areas; and (2) the Secretary shall give special consideration to areas that are underserved with respect to such services. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2653, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 608; amended Pub. L. 106−345, title III, Sec. 311, Oct. 20, 2000, 114 Stat. 1345.) −MISC1− AMENDMENTS 2000 − Subsec. (d). Pub. L. 106−345 added subsec. (d). −End− −CITE− 42 USC Sec. 300ff−54 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE
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CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart i − categorical grants −HEAD− Sec. 300ff−54. Miscellaneous provisions −STATUTE− (a) Services for individuals with hemophilia In making grants under section 300ff−51 of this title, the Secretary shall ensure that any such grants made regarding the provision of early intervention services to individuals with hemophilia are made through the network of comprehensive hemophilia diagnostic and treatment centers. (b) Technical assistance The Secretary may, directly or through grants or contracts, provide technical assistance to nonprofit private entities regarding the process of submitting to the Secretary applications for grants under section 300ff−51 of this title, and may provide technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to such section. (c) Planning and development grants (1) In general The Secretary may provide planning grants to public and nonprofit private entities for purposes of − (A) enabling such entities to provide HIV early intervention
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services; and (B) assisting the entities in expanding their capacity to provide HIV−related health services, including early intervention services, in low−income communities and affected subpopulations that are underserved with respect to such services (subject to the condition that a grant pursuant to this subparagraph may not be expended to purchase or improve land, or to purchase, construct, or permanently improve, other than minor remodeling, any building or other facility). (2) Requirement The Secretary may only award a grant to an entity under paragraph (1) if the Secretary determines that the entity will use such grant to assist the entity in qualifying for a grant under section 300ff−51 of this title. (3) Preference In awarding grants under paragraph (1), the Secretary shall give preference to entities that provide primary care services in rural or underserved communities. (4) Amount and duration of grants (A) Early intervention services A grant under paragraph (1)(A) may be made in an amount not to exceed $50,000. (B) Capacity development (i) Amount A grant under paragraph (1)(B) may be made in an amount not to exceed $150,000.
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(ii) Duration The total duration of a grant under paragraph (1)(B), including any renewal, may not exceed 3 years. (5) Limitation Not to exceed 5 percent of the amount appropriated for a fiscal year under section 300ff−55 of this title may be used to carry out this section. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2654, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 608; amended Pub. L. 104−146, Sec. 3(d)(3), May 20, 1996, 110 Stat. 1357; Pub. L. 106−345, title III, Sec. 312, Oct. 20, 2000, 114 Stat. 1345.) −MISC1− AMENDMENTS 2000 − Subsec. (c)(1). Pub. L. 106−345, Sec. 312(a), substituted "planning grants to public and nonprofit private entities for purposes of − " and subpars. (A) and (B) for "planning grants, in an amount not to exceed $50,000 for each such grant, to public and nonprofit private entities for the purpose of enabling such entities to provide HIV early intervention services." Subsec. (c)(4). Pub. L. 106−345, Sec. 312(b)(2), added par. (4). Former par. (4) redesignated (5). Subsec. (c)(5). Pub. L. 106−345, Sec. 312(b)(1), (c), redesignated par. (4) as (5) and substituted "5 percent" for "1 percent".
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1996 − Subsec. (c). Pub. L. 104−146 added subsec. (c). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−55 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart i − categorical grants −HEAD− Sec. 300ff−55. Authorization of appropriations −STATUTE− For the purpose of making grants under section 300ff−51 of this title, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2655, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 609; amended Pub. L. 104−146, Sec. 3(d)(4), May 20, 1996, 110 Stat. 1358; Pub. L. 106−345, title III, Sec. 313, Oct. 20, 2000, 114 Stat. 1346.)
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−MISC1− AMENDMENTS 2000 − Pub. L. 106−345 substituted "for each of the fiscal years 2001 through 2005" for "in each of the fiscal years 1996, 1997, 1998, 1999, and 2000". 1996 − Pub. L. 104−146 substituted "such sums as may be necessary in each of the fiscal years 1996, 1997, 1998, 1999, and 2000." for "$75,000,000 for fiscal years 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995." EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ff−54 of this title. −End− −CITE− 42 USC subpart ii − general provisions 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions −HEAD−
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SUBPART II − GENERAL PROVISIONS −MISC1− PRIOR PROVISIONS A prior subpart II, consisting of sections 300ff−51 to 300ff−55, was redesignated subpart I of this part by Pub. L. 106−345, title III, Sec. 301(b)(1), Oct. 20, 2000, 114 Stat. 1345. AMENDMENTS Pub. L. 106−345, title III, Sec. 301(b)(1), Oct. 20, 2000, 114 Stat. 1345, redesignated subpart III as subpart II. −End− −CITE− 42 USC Sec. 300ff−61 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions −HEAD− Sec. 300ff−61. Confidentiality and informed consent −STATUTE− (a) Confidentiality The Secretary may not make a grant under this part unless, in the case of any entity applying for a grant under section 300ff−51 of this title, the entity agrees to ensure that information regarding the receipt of early intervention services pursuant to the grant is
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maintained confidentially in a manner not inconsistent with applicable law. (b) Informed consent (1) In general The Secretary may not make a grant under this part unless the applicant for the grant agrees that, in testing an individual for HIV disease, the applicant will test an individual only after obtaining from the individual a statement, made in writing and signed by the individual, declaring that the individual has undergone the counseling described in section 300ff−62(a) of this title and that the decision of the individual with respect to undergoing such testing is voluntarily made. (2) Provisions regarding anonymous testing (A) If, pursuant to section 300ff−64(b) of this title, an individual will undergo testing pursuant to this part through the use of a pseudonym, a grantee under such section shall be considered to be in compliance with the agreement made under paragraph (1) if the individual signs the statement described in such subsection using the pseudonym. (B) If, pursuant to section 300ff−64(b) of this title, an individual will undergo testing pursuant to this part without providing any information relating to the identity of the individual, a grantee under such section shall be considered to be in compliance with the agreement made under paragraph (1) if the individual orally provides the declaration described in such paragraph.
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−SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2661, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 609; amended Pub. L. 106−345, title III, Sec. 301(b)(2), Oct. 20, 2000, 114 Stat. 1345.) −MISC1− AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−345 struck out par. (1) and par. (2) designation. Prior to amendment, par. (1) read as follows: "in the case of any State applying for a grant under section 300ff−41 of this title, the State agrees to ensure that information regarding the receipt of early intervention services is maintained confidentially pursuant to law or regulations in a manner not inconsistent with applicable law; and". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ff−63 of this title. −End− −CITE− 42 USC Sec. 300ff−62 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions
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−HEAD− Sec. 300ff−62. Provision of certain counseling services −STATUTE− (a) Counseling before testing The Secretary may not make a grant under this part unless the applicant for the grant agrees that, before testing an individual for HIV disease, the applicant will provide to the individual appropriate counseling regarding the disease (based on the most recently available scientific data), including counseling on − (1) measures for the prevention of exposure to, and the transmission of, HIV; (2) the accuracy and reliability of the results of testing for HIV disease; (3) the significance of the results of such testing, including the potential for developing acquired immune deficiency syndrome; (4) encouraging the individual, as appropriate, to undergo such testing; (5) the benefits of such testing, including the medical benefits of diagnosing HIV disease in the early stages and the medical benefits of receiving early intervention services during such stages; (6) provisions of law relating to the confidentiality of the process of receiving such services, including information regarding any disclosures that may be authorized under applicable law and information regarding the availability of anonymous counseling and testing pursuant to section 300ff−64(b) of this
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title; and (7) provisions of applicable law relating to discrimination against individuals with HIV disease. (b) Counseling of individuals with negative test results The Secretary may not make a grant under this part unless the applicant for the grant agrees that, if the results of testing conducted for HIV disease indicate that an individual does not have the disease, the applicant will review for the individual the information provided pursuant to subsection (a) of this section, including − (1) the information described in paragraphs (1) through (3) of such subsection; and (2) the appropriateness of further counseling, testing, and education of the individual regarding such disease. (c) Counseling of individuals with positive test results The Secretary may not make a grant under this part unless the applicant for the grant agrees that, if the results of testing for HIV disease indicate that the individual has the disease, the applicant will provide to the individual appropriate counseling regarding such disease, including − (1) reviewing the information described in paragraphs (1) through (3) of subsection (a) of this section; (2) reviewing the appropriateness of further counseling, testing, and education of the individual regarding such disease; and (3) providing counseling −
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(A) on the availability, through the applicant, of early intervention services; (B) on the availability in the geographic area of appropriate health care, mental health care, and social and support services, including providing referrals for such services, as appropriate; (C)(i) that explains the benefits the benefits of locating and counseling any individual by whom the infected individual may have been exposed to HIV and any individual whom the infected individual may have exposed to HIV; and (ii) that emphasizes it is the duty of infected individuals to disclose their infected status to their sexual partners and their partners in the sharing of hypodermic needles; that provides advice to infected individuals on the manner in which such disclosures can be made; and that emphasizes that it is the continuing duty of the individuals to avoid any behaviors that will expose others to HIV.(!1) (D) on the availability of the services of public health authorities with respect to locating and counseling any individual described in subparagraph (C). (d) Additional requirements regarding appropriate counseling The Secretary may not make a grant under this part unless the applicant for the grant agrees that, in counseling individuals with respect to HIV disease, the applicant will ensure that the counseling is provided under conditions appropriate to the needs of the individuals.
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(e) Counseling of emergency response employees The Secretary may not make a grant under this part to a State unless the State agrees that, in counseling individuals with respect to HIV disease, the State will ensure that, in the case of emergency response employees, the counseling is provided to such employees under conditions appropriate to the needs of the employees regarding the counseling. (f) Rule of construction regarding counseling without testing Agreements made pursuant to this section may not be construed to prohibit any grantee under this part from expending the grant for the purpose of providing counseling services described in this section to an individual who does not undergo testing for HIV disease as a result of the grantee or the individual determining that such testing of the individual is not appropriate. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2662, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 610; amended Pub. L. 106−345, title III, Sec. 321, Oct. 20, 2000, 114 Stat. 1346.) −MISC1− AMENDMENTS 2000 − Subsec. (c)(3). Pub. L. 106−345, Sec. 321(1), in introductory provisions struck out "on" after "counseling". Subsec. (c)(3)(A), (B). Pub. L. 106−345, Sec. 321(2), inserted "on" before "the availability". Subsec. (c)(3)(C). Pub. L. 106−345, Sec. 321(3), designated
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existing provisions as cl. (i), inserted "that explains" before "the benefits", and added cl. (ii). Subsec. (c)(3)(D). Pub. L. 106−345, Sec. 321(2), inserted "on" before "the availability". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−51, 300ff−61, 300ff−63 of this title. −FOOTNOTE− (!1) So in original. The period probably should be "; and". −End− −CITE− 42 USC Sec. 300ff−63 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions −HEAD− Sec. 300ff−63. Applicability of requirements regarding confidentiality, informed consent, and counseling −STATUTE− The Secretary may not make a grant under this part unless the applicant for the grant agrees that, with respect to testing for HIV disease, any such testing carried out by the applicant will,
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without regard to whether such testing is carried out with Federal funds, be carried out in accordance with conditions described in sections 300ff−61 and 300ff−62 of this title. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2663, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 611.) −End− −CITE− 42 USC Sec. 300ff−64 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions −HEAD− Sec. 300ff−64. Additional required agreements −STATUTE− (a) Reports to Secretary The Secretary may not make a grant under this part unless − (1) the applicant submits to the Secretary − (A) a specification of the expenditures made by the applicant for early intervention services for the fiscal year preceding the fiscal year for which the applicant is applying to receive the grant; and (B) an estimate of the number of individuals to whom the
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applicant has provided such services for such fiscal year; and (2) the applicant agrees to submit to the Secretary a report providing − (A) the number of individuals to whom the applicant provides early intervention services pursuant to the grant; (B) epidemiological and demographic data on the population of such individuals; (C) the extent to which the costs of HIV−related health care for such individuals are paid by third−party payors; (D) the average costs of providing each category of early intervention service; and (E) the aggregate amounts expended for each such category. (b) Provision of opportunities for anonymous counseling and testing The Secretary may not make a grant under this part unless the applicant for the grant agrees that, to the extent permitted under State law, regulation or rule, the applicant will offer substantial opportunities for an individual − (1) to undergo counseling and testing regarding HIV disease without being required to provide any information relating to the identity of the individual; and (2) to undergo such counseling and testing through the use of a pseudonym. (c) Prohibition against requiring testing as condition of receiving other health services The Secretary may not make a grant under this part unless the applicant for the grant agrees that, with respect to an individual
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seeking health services from the applicant, the applicant will not require the individual to undergo testing for HIV as a condition of receiving any health services unless such testing is medically indicated in the provision of the health services sought by the individual. (d) Maintenance of support The Secretary may not make a grant under this part unless the applicant for the grant agrees to maintain the expenditures of the applicant for early intervention services at a level equal to not less than the level of such expenditures maintained by the State for the fiscal year preceding the fiscal year for which the applicant is applying to receive the grant. (e) Requirements regarding imposition of charges for services (1) In general The Secretary may not make a grant under this part unless, subject to paragraph (5), the applicant for the grant agrees that − (A) in the case of individuals with an income less than or equal to 100 percent of the official poverty line, the applicant will not impose a charge on any such individual for the provision of early intervention services under the grant; (B) in the case of individuals with an income greater than 100 percent of the official poverty line, the applicant − (i) will impose a charge on each such individual for the provision of such services; and (ii) will impose the charge according to a schedule of
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charges that is made available to the public. (2) Limitation on charges regarding individuals subject to charges With respect to the imposition of a charge for purposes of paragraph (1)(B)(ii), the Secretary may not make a grant under this part unless, subject to paragraph (5), the applicant for the grant agrees that − (A) in the case of individuals with an income greater than 100 percent of the official poverty line and not exceeding 200 percent of such poverty line, the applicant will not, for any calendar year, impose charges in an amount exceeding 5 percent of the annual gross income of the individual involved; (B) in the case of individuals with an income greater than 200 percent of the official poverty line and not exceeding 300 percent of such poverty line, the applicant will not, for any calendar year, impose charges in an amount exceeding 7 percent of the annual gross income of the individual involved; and (C) in the case of individuals with an income greater than 300 percent of the official poverty line, the applicant will not, for any calendar year, impose charges in an amount exceeding 10 percent of the annual gross income of the individual involved. (3) Assessment of charge With respect to compliance with the agreement made under paragraph (1), a grantee under this part may, in the case of individuals subject to a charge for purposes of such paragraph −
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(A) assess the amount of the charge in the discretion of the grantee, including imposing only a nominal charge for the provision of services, subject to the provisions of such paragraph regarding public schedules and of paragraph (2) regarding limitations on the maximum amount of charges; and (B) take into consideration the medical expenses of individuals in assessing the amount of the charge, subject to such provisions. (4) Applicability of limitation on amount of charge The Secretary may not make a grant under this part unless the applicant for the grant agrees that the limitations established in paragraph (2) regarding the imposition of charges for services applies to the annual aggregate of charges imposed for such services, without regard to whether they are characterized as enrollment fees, premiums, deductibles, cost sharing, copayments, coinsurance, or similar charges. (5) Waiver regarding certain secondary agreements The requirement established in paragraph (1)(B)(i) shall be waived by the Secretary in the case of any entity for whom the Secretary has granted a waiver under section 300ff−52(b)(2) of this title. (f) Relationship to items and services under other programs (1) In general The Secretary may not make a grant under this part unless the applicant for the grant agrees that, subject to paragraph (2), the grant will not be expended by the applicant, or by any entity
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receiving amounts from the applicant for the provision of early intervention services, to make payment for any such service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service − (A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or (B) by an entity that provides health services on a prepaid basis. (2) Applicability to certain secondary agreements for provision of services An agreement made under paragraph (1) shall not apply in the case of an entity through which a grantee under this part provides early intervention services if the Secretary has provided a waiver under section 300ff−52(b)(2) of this title regarding the entity. (g) Administration of grant The Secretary may not make a grant under this part unless the applicant for the grant agrees that − (1) the applicant will not expend amounts received pursuant to this part for any purpose other than the purposes described in the subpart under which the grant involved is made; (2) the applicant will establish such procedures for fiscal control and fund accounting as may be necessary to ensure proper disbursement and accounting with respect to the grant; (3) the applicant will not expend more than 10 percent
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including planning and evaluation of the grant for administrative expenses with respect to the grant; (4) the applicant will submit evidence that the proposed program is consistent with the statewide coordinated statement of need and agree to participate in the ongoing revision of such statement of need; and (5) the applicant will provide for the establishment of a quality management program − (A) to assess the extent to which medical services funded under this subchapter that are provided to patients are consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infections, and as applicable, to develop strategies for ensuring that such services are consistent with the guidelines; and (B) to ensure that improvements in the access to and quality of HIV health services are addressed. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2664, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 611; amended Pub. L. 104−146, Sec. 3(d)(5), May 20, 1996, 110 Stat. 1358; Pub. L. 106−345, title III, Secs. 301(b)(3), 322, Oct. 20, 2000, 114 Stat. 1345, 1346.) −MISC1− AMENDMENTS 2000 − Subsecs. (e)(5), (f)(2). Pub. L. 106−345, Sec.
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301(b)(3)(A), (B), struck out "300ff−42(b) or" after "a waiver under section". Subsec. (g)(3). Pub. L. 106−345, Sec. 322(1)(A), substituted "10 percent" for "7.5 percent". Subsec. (g)(5). Pub. L. 106−345, Sec. 322(1)(B), (2), (3), added par. (5). Subsec. (h). Pub. L. 106−345, Sec. 301(b)(3)(C), struck out heading and text of subsec. (h). Text read as follows: "A State may not use amounts received under a grant awarded under section 300ff−41 of this title to purchase or improve land, or to purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or to make cash payments to intended recipients of services." 1996 − Subsec. (g)(3). Pub. L. 104−146, Sec. 3(d)(5)(B)(i), substituted "7.5 percent including planning and evaluation" for "5 percent". Subsec. (g)(4). Pub. L. 104−146, Sec. 3(d)(5)(A), (B)(ii), (C), added par. (4). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−61, 300ff−62, 300ff−65 of this title.
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−End− −CITE− 42 USC Sec. 300ff−65 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions −HEAD− Sec. 300ff−65. Requirement of submission of application containing certain agreements and assurances −STATUTE− The Secretary may not make a grant under this part unless − (1) an application for the grant is submitted to the Secretary containing agreements and assurances in accordance with this part and containing the information specified in section 300ff−64(a)(1) of this title; (2) with respect to such agreements, the application provides assurances of compliance satisfactory to the Secretary; and (3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this part. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2665, as added Pub. L.
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101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 614.) −End− −CITE− 42 USC Sec. 300ff−66 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions −HEAD− Sec. 300ff−66. Provision by Secretary of supplies and services in lieu of grant funds −STATUTE− (a) In general Upon the request of a grantee under this part, the Secretary may, subject to subsection (b) of this section, provide supplies, equipment, and services for the purpose of aiding the grantee in providing early intervention services and, for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services. (b) Limitation With respect to a request described in subsection (a) of this section, the Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or
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services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2666, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 614.) −End− −CITE− 42 USC Sec. 300ff−67 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part C − Early Intervention Services subpart ii − general provisions −HEAD− Sec. 300ff−67. Use of funds −STATUTE− Counseling programs carried out under this part − (1) shall not be designed to promote or encourage, directly, intravenous drug abuse or sexual activity, homosexual or heterosexual; (2) shall be designed to reduce exposure to and transmission of HIV disease by providing accurate information; and (3) shall provide information on the health risks of promiscuous sexual activity and intravenous drug abuse.
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−SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2667, as added Pub. L. 101−381, title III, Sec. 301(a), Aug. 18, 1990, 104 Stat. 614.) −End− −CITE− 42 USC Part D − General Provisions 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− PART D − GENERAL PROVISIONS −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in sections 300ff−12, 300ff−101 of this title. −End− −CITE− 42 USC Sec. 300ff−71 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD−
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Sec. 300ff−71. Grants for coordinated services and access to research for women, infants, children, and youth −STATUTE− (a) In general The Secretary, acting through the Administrator of the Health Resources and Services Administration and in consultation with the Director of the National Institutes of Health, shall make grants to public and nonprofit private entities that provide primary care (directly or through contracts) for the following purposes: (1) Providing through such entities, in accordance with this section, opportunities for women, infants, children, and youth to be voluntary participants in research of potential clinical benefit to individuals with HIV disease. (2) In the case of women, infants, children, and youth with HIV disease, and the families of such individuals, providing to such individuals − (A) health care on an outpatient basis; and (B) additional services in accordance with subsection (d) of this section. (b) Provisions regarding participation in research (1) In general With respect to the projects of research with which an applicant under subsection (a) of this section is concerned, the Secretary may make a grant under such subsection to the applicant only if the following conditions are met: (A) The applicant agrees to make reasonable efforts −
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(i) to identify which of the patients of the applicant are women, infants, children, and youth who would be appropriate participants in the projects; (ii) to carry out clause (i) through the use of criteria provided for such purpose by the entities that will be conducting the projects of research; and (iii) to offer women, infants, children, and youth the opportunity to participate in the projects (as appropriate), including the provision of services under subsection (d)(3) of this section. (B) The applicant agrees that, in the case of the research−related functions to be carried out by the applicant pursuant to subsection (a)(1) of this section, the applicant will comply with accepted standards that are applicable to such functions (including accepted standards regarding informed consent and other protections for human subjects). (C) The applicant will demonstrate linkages to research and how access to such research is being offered to patients. (2) Prohibition Receipt of services by a patient shall not be conditioned upon the consent of the patient to participate in research. (c) Provisions regarding conduct of research (1) In general With respect to eligibility for a grant under subsection (a) of this section: (A) A project of research for which subjects are sought
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pursuant to such subsection may be conducted by the applicant for the grant, or by an entity with which the applicant has made arrangements for purposes of the grant. The grant may not be expended for the conduct of any project of research, except for such research−related functions as are appropriate for providing opportunities under subsection (a)(1) of this section (including the functions specified in subsection (b)(1) of this section). (B) The grant may be made only if the Secretary makes the following determinations: (i) The applicant or other entity (as the case may be under subparagraph (A)) is appropriately qualified to conduct the project of research. An entity shall be considered to be so qualified if any research protocol of the entity has been recommended for funding under this chapter pursuant to technical and scientific peer review through the National Institutes of Health. (ii) The project of research is being conducted in accordance with a research protocol to which the Secretary gives priority regarding the prevention or treatment of HIV disease in women, infants, children, or youth, subject to paragraph (2). (2) List of research protocols (A) In general From among the research protocols described in paragraph (1)(B)(ii), the Secretary shall establish a list of research
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protocols that are appropriate for purposes of subsection (a)(1) of this section. Such list shall be established only after consultation with public and private entities that conduct such research, and with providers of services under subsection (a) of this section and recipients of such services. (B) Discretion of Secretary The Secretary may authorize the use, for purposes of subsection (a)(1) of this section, of a research protocol that is not included on the list under subparagraph (A). The Secretary may waive the requirement specified in paragraph (1)(B)(ii) in such circumstances as the Secretary determines to be appropriate. (d) Additional services for patients and families A grant under subsection (a) of this section may be made only if the applicant for the grant agrees as follows: (1) The applicant will provide for the case management of the patient involved and the family of the patient. (2) The applicant will provide for the patient and the family of the patient − (A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and (B) referrals for other social and support services, as appropriate. (3) The applicant will provide the patient and the family of the patient with such transportation, child care, and other incidental services as may be necessary to enable the patient and
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the family to participate in the program established by the applicant pursuant to such subsection. (4) The applicant will provide individuals with information and education on opportunities to participate in HIV/AIDS−related clinical research. (e) Coordination with other entities A grant under subsection (a) of this section may be made only if the applicant for the grant agrees as follows: (1) The applicant will coordinate activities under the grant with other providers of health care services under this chapter, and under title V of the Social Security Act [42 U.S.C. 701 et seq.]. (2) The applicant will participate in the statewide coordinated statement of need under part B of this subchapter (where it has been initiated by the public health agency responsible for administering grants under part B of this subchapter) and in revisions of such statement. (f) Administration (1) Application A grant under subsection (a) of this section may be made only if an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. (2) Quality management program A grantee under this section shall implement a quality
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management program to assess the extent to which HIV health services provided to patients under the grant are consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infection, and as applicable, to develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to and quality of HIV health services. (g) Coordination with National Institutes of Health The Secretary shall develop and implement a plan that provides for the coordination of the activities of the National Institutes of Health with the activities carried out under this section. In carrying out the preceding sentence, the Secretary shall ensure that projects of research conducted or supported by such Institutes are made aware of applicants and grantees under subsection (a) of this section, shall require that the projects, as appropriate, enter into arrangements for purposes of such subsection, and shall require that each project entering into such an arrangement inform the applicant or grantee under such subsection of the needs of the project for the participation of women, infants, children, and youth. The Secretary acting through the Director of NIH, shall examine the distribution and availability of ongoing and appropriate HIV/AIDS−related research projects to existing sites under this section for purposes of enhancing and expanding voluntary access to HIV−related research, especially within communities that are not reasonably served by such projects. Not later than 12 months after October 20, 2000, the Secretary shall
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prepare and submit to the appropriate committees of Congress a report that describes the findings made by the Director and the manner in which the conclusions based on those findings can be addressed. (h) Annual review of programs; evaluations (1) Review regarding access to and participation in programs With respect to a grant under subsection (a) of this section for an entity for a fiscal year, the Secretary shall, not later than 180 days after the end of the fiscal year, provide for the conduct and completion of a review of the operation during the year of the program carried out under such subsection by the entity. The purpose of such review shall be the development of recommendations, as appropriate, for improvements in the following: (A) Procedures used by the entity to allocate opportunities and services under subsection (a) of this section among patients of the entity who are women, infants, children, or youth. (B) Other procedures or policies of the entity regarding the participation of such individuals in such program. (2) Evaluations The Secretary shall, directly or through contracts with public and private entities, provide for evaluations of programs carried out pursuant to subsection (a) of this section. (i) Limitation on administrative expenses (1) Determination by Secretary
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Not later than 12 months after October 20, 2000, the Secretary, in consultation with grantees under this part, shall conduct a review of the administrative, program support, and direct service−related activities that are carried out under this part to ensure that eligible individuals have access to quality, HIV−related health and support services and research opportunities under this part, and to support the provision of such services. (2) Requirements (A) In general Not later than 180 days after the expiration of the 12−month period referred to in paragraph (1) the Secretary, in consultation with grantees under this part, shall determine the relationship between the costs of the activities referred to in paragraph (1) and the access of eligible individuals to the services and research opportunities described in such paragraph. (B) Limitation After a final determination under subparagraph (A), the Secretary may not make a grant under this part unless the grantee complies with such requirements as may be included in such determination. (j) Training and technical assistance Of the amounts appropriated under subsection (j) of this section for a fiscal year, the Secretary may use not more than five percent to provide, directly or through contracts with public and private
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entities (which may include grantees under subsection (a) of this section), training and technical assistance to assist applicants and grantees under subsection (a) of this section in complying with the requirements of this section. (k) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2671, as added Pub. L. 101−381, title IV, Sec. 401, Aug. 18, 1990, 104 Stat. 617; amended Pub. L. 104−146, Sec. 3(e), May 20, 1996, 110 Stat. 1358; Pub. L. 106−345, title IV, Sec. 401, Oct. 20, 2000, 114 Stat. 1347.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in subsec. (e)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title V of the Act is classified generally to subchapter V (Sec. 701 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. −MISC1− AMENDMENTS 2000 − Pub. L. 106−345, Sec. 401(a)−(d), which directed amendments to subsecs. (b), (d), (f), and (g) of "section 2671", without indicating the act to be amended, was executed by making the amendments to this section, which is section 2671 of the Public
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Health Service Act, to reflect the probable intent of Congress. See below. Subsec. (b)(1)(C), (D). Pub. L. 106−345, Sec. 401(a)(1), added subpar. (C) and struck out former subpars. (C) and (D) which read as follows: "(C) For the first and second fiscal years for which grants under subsection (a) of this section are to be made to the applicant, the applicant agrees that, not later than the end of the second fiscal year of receiving such a grant, a significant number of women, infants, children, and youth who are patients of the applicant will be participating in the projects of research. "(D) Except as provided in paragraph (3) (and paragraph (4), as applicable), for the third and subsequent fiscal years for which such grants are to be made to the applicant, the Secretary has determined that a significant number of such individuals are participating in the projects." Subsec. (b)(3). Pub. L. 106−345, Sec. 401(a)(2), struck out heading and text of par. (3). Text read as follows: "In administering the requirement of paragraph (1)(D), the Secretary shall take into account circumstances in which a grantee under subsection (a) of this section is temporarily unable to comply with the requirement for reasons beyond the control of the grantee, and shall in such circumstances provide to the grantee a reasonable period of opportunity in which to reestablish compliance with the requirement." Subsec. (b)(4). Pub. L. 106−345, Sec. 401(a)(2), struck out
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heading and text of par. (4). Text consisted of subpars. (A) and (B) relating to a temporary waiver of requirement of significant participation for original grantees. Subsec. (d)(4). Pub. L. 106−345, Sec. 401(b), added par. (4). Subsec. (f). Pub. L. 106−345, Sec. 401(c), substituted "Administration" for "Application" in subsec. heading, designated existing provisions as par. (1), inserted par. (1) heading, and added par. (2). Subsec. (g). Pub. L. 106−345, Sec. 401(d), inserted at end "The Secretary acting through the Director of NIH, shall examine the distribution and availability of ongoing and appropriate HIV/AIDS−related research projects to existing sites under this section for purposes of enhancing and expanding voluntary access to HIV−related research, especially within communities that are not reasonably served by such projects. Not later than 12 months after October 20, 2000, the Secretary shall prepare and submit to the appropriate committees of Congress a report that describes the findings made by the Director and the manner in which the conclusions based on those findings can be addressed." Subsecs. (i), (j). Pub. L. 106−345, Sec. 401(e), added subsec. (i) and redesignated former subsec. (i) as (j). Former subsec. (j) redesignated (k). Subsec. (k). Pub. L. 106−345, Sec. 401(f), substituted "fiscal years 2001 through 2005" for "fiscal years 1996 through 2000". Pub. L. 106−345, Sec. 401(e)(1), redesignated subsec. (j) as (k). 1996 − Pub. L. 104−146 amended section generally, substituting
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provisions authorizing grants for coordinated services and access to research for women, infants, children, and youth living with the HIV virus for provisions authorizing demonstration grants for research and services for pediatric patients regarding AIDS. EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−12, 300ff−23, 300ff−51 of this title. −End− −CITE− 42 USC Sec. 300ff−72 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− Sec. 300ff−72. Provisions relating to blood banks −STATUTE− (a) Informational and training programs The Secretary shall − (1) develop and make available to technical and supervisory
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personnel employed at blood banks and facilities that produce blood products, materials and information concerning measures that may be implemented to protect the safety of the blood supply with respect to the activities of such personnel, including − (A) state−of−the−art diagnostic and testing procedures relating to pathogens in the blood supply; and (B) quality assurance procedures relating to the safety of the blood supply and of blood products; and (2) develop and implement a training program that is designed to increase the number of employees of the Department of Health and Human Services who are qualified to conduct inspections of blood banks and facilities that produce blood products. (b) Updates The Secretary shall periodically review and update the materials and information made available under informational or training programs conducted under subsection (a) of this section. (c) Authorization of appropriations There are authorized to be appropriated to carry out this section, $1,500,000 for fiscal year 1991, and such sums as may be necessary in each of the fiscal years 1992 through 1995. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2672, as added Pub. L. 101−381, title IV, Sec. 401, Aug. 18, 1990, 104 Stat. 618.) −End− −CITE− 42 USC Sec. 300ff−73 01/06/03
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−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− Sec. 300ff−73. Research, evaluation, and assessment program −STATUTE− (a) Establishment The Secretary, acting through the Director of the Agency for Healthcare Research and Quality, shall establish a program to enable independent research to be conducted by individuals and organizations with appropriate expertise in the fields of health, health policy, and economics (particularly health care economics) to develop − (1) a comparative assessment of the impact and cost−effectiveness of major models for organizing and delivering HIV−related health care, mental health care, early intervention, and support services, that shall include a report concerning patient outcomes, satisfaction, perceived quality of care, and total cumulative cost, and a review of the appropriateness of such models for the delivery of health and support services to infants, children, women, and families with HIV disease; (2) through a review of private sector financing mechanisms for the delivery of HIV−related health and support services, an assessment of strategies for maintaining private health benefits
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for individuals with HIV disease and an assessment of specific business practices or regulatory barriers that could serve to reduce access to private sector benefit programs; (3) an assessment of the manner in which different points−of−entry to the health care system affect the cost, quality, and outcome of the care and treatment of individuals and families with HIV disease; and (4) a summary report concerning the major and continuing unmet needs in health care, mental health care, early intervention, and support services for individuals and families with HIV disease in urban and rural areas. (b) Report Not later than 2 years after August 18, 1990, and periodically thereafter, the Secretary shall prepare 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, a progress report that contains the findings and assessments developed under subsection (a) of this section. (c) Authorization of appropriations There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of the fiscal years 1991 through 1995. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2673, as added Pub. L. 101−381, title IV, Sec. 401, Aug. 18, 1990, 104 Stat. 619; amended Pub. L. 106−345, title V, Sec. 503(a)(2), Oct. 20, 2000, 114 Stat.
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1354.) −MISC1− AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−345 substituted "the Director of the Agency for Healthcare Research and Quality" for "the Agency for Health Care Policy and Research" in introductory provisions. −CHANGE− CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −End− −CITE− 42 USC Sec. 300ff−74 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions
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−HEAD− Sec. 300ff−74. Evaluations and reports −STATUTE− (a) Evaluations The Secretary shall, directly or through grants and contracts, evaluate programs carried out under this subchapter. (b) Report to Congress The Secretary shall, not later than October 1, 1996, and annually thereafter, prepare and submit to the appropriate Committees of Congress a report − (1) evaluating the programs carried out under this subchapter; and (2) making such recommendations for administrative and legislative initiatives with respect to this subchapter as the Secretary determines to be appropriate. (c) Authorization of appropriations There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of the fiscal years 2001 through 2005. (d) Allocation of funds The Secretary shall carry out this section with amounts available under section 238j of this title. Such amounts are in addition to any other amounts that are available to the Secretary for such purpose. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2674, as added Pub. L.
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101−381, title IV, Sec. 401, Aug. 18, 1990, 104 Stat. 620; amended Pub. L. 104−146, Sec. 3(f), May 20, 1996, 110 Stat. 1362; Pub. L. 106−345, title IV, Sec. 411, Oct. 20, 2000, 114 Stat. 1350.) −MISC1− AMENDMENTS 2000 − Subsec. (c). Pub. L. 106−345 substituted "2001 through 2005" for "1991 through 1995". 1996 − Subsec. (b). Pub. L. 104−146, Sec. 3(f)(1)(A), substituted "not later than October 1, 1996," for "not later than 1 year after the date on which amounts are first appropriated under this subchapter," in introductory provisions. Subsec. (b)(1). Pub. L. 104−146, Sec. 3(f)(1)(B), added par. (1) and struck out former par. (1) which read as follows: "summarizing all of the reports that are required to be submitted to the Secretary under this subchapter;". Subsec. (b)(2) to (4). Pub. L. 104−146, Sec. 3(f)(1)(B), (C), redesignated par. (4) as (2) and struck out former pars. (2) and (3) which read as follows: "(2) recommending criteria to be used in determining the geographic areas with the most substantial need for HIV−related health services; "(3) summarizing all of the evaluations carried out pursuant to subsection (a) of this section during the period for which the report under this subsection is prepared; and". Subsec. (d). Pub. L. 104−146, Sec. 3(f)(2), added subsec. (d). EFFECTIVE DATE OF 1996 AMENDMENT
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Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−75 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− Sec. 300ff−75. Coordination −STATUTE− (a) Requirement The Secretary shall ensure that the Health Resources and Services Administration, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, and the Health Care Financing Administration coordinate the planning, funding, and implementation of Federal HIV programs to enhance the continuity of care and prevention services for individuals with HIV disease or those at risk of such disease. The Secretary shall consult with other Federal agencies, including the Department of Veterans Affairs, as needed and utilize planning information submitted to such agencies by the States and entities eligible for support.
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(b) Report The Secretary shall biennially prepare and submit to the appropriate committees of the Congress a report concerning the coordination efforts at the Federal, State, and local levels described in this section, including a description of Federal barriers to HIV program integration and a strategy for eliminating such barriers and enhancing the continuity of care and prevention services for individuals with HIV disease or those at risk of such disease. (c) Integration by State As a condition of receipt of funds under this subchapter, a State shall assure the Secretary that health support services funded under this subchapter will be integrated with each other, that programs will be coordinated with other available programs (including Medicaid) and that the continuity of care and prevention services of individuals with HIV disease is enhanced. (d) Integration by local or private entities As a condition of receipt of funds under this subchapter, a local government or private nonprofit entity shall assure the Secretary that services funded under this subchapter will be integrated with each other, that programs will be coordinated with other available programs (including Medicaid) and that the continuity of care and prevention services of individuals with HIV is enhanced. (e) Recommendations regarding release of prisoners After consultation with the Attorney General and the Director of the Bureau of Prisons, with States, with eligible areas under part
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A of this subchapter, and with entities that receive amounts from grants under part A or B of this subchapter, the Secretary, consistent with the coordination required in subsection (a) of this section, shall develop a plan for the medical case management of and the provision of support services to individuals who were Federal or State prisoners and had HIV disease as of the date on which the individuals were released from the custody of the penal system. The Secretary shall submit the plan to the Congress not later than 2 years after October 20, 2000. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2675, as added Pub. L. 101−381, title IV, Sec. 401, Aug. 18, 1990, 104 Stat. 620; amended Pub. L. 102−531, title III, Sec. 312(d)(34), Oct. 27, 1992, 106 Stat. 3506; Pub. L. 106−345, title IV, Secs. 413, 414, Oct. 20, 2000, 114 Stat. 1350, 1351.) −MISC1− AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−345, Sec. 413(1), amended heading and text of subsec. (a) generally. Prior to amendment, text read as follows: "The Secretary shall assure that the Health Resources and Services Administration and the Centers for Disease Control and Prevention will coordinate the planning of the funding of programs authorized under this subchapter to assure that health support services for individuals with HIV disease are integrated with each other and that the continuity of care of individuals with HIV disease is enhanced. In coordinating the allocation of funds made
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available under this subchapter the Health Resources and Services Administration and the Centers for Disease Control and Prevention shall utilize planning information submitted to such agencies by the States and entities eligible for support." Subsec. (b). Pub. L. 106−345, Sec. 413(3), added subsec. (b). Former subsec. (b) redesignated (c). Subsecs. (c), (d). Pub. L. 106−345, Sec. 413(2), (4), redesignated subsecs. (b) and (c) as (c) and (d), respectively, and inserted "and prevention services" after "continuity of care". Subsec. (e). Pub. L. 106−345, Sec. 414, added subsec. (e). 1992 − Subsec. (a). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control" in two places. −End− −CITE− 42 USC Sec. 300ff−75a 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− Sec. 300ff−75a. Audits −STATUTE− For fiscal year 2002 and subsequent fiscal years, the Secretary may reduce the amounts of grants under this subchapter to a State
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or political subdivision of a State for a fiscal year if, with respect to such grants for the second preceding fiscal year, the State or subdivision fails to prepare audits in accordance with the procedures of section 7502 of title 31. The Secretary shall annually select representative samples of such audits, prepare summaries of the selected audits, and submit the summaries to the Congress. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2675A, as added Pub. L. 106−345, title IV, Sec. 415, Oct. 20, 2000, 114 Stat. 1351.) −End− −CITE− 42 USC Sec. 300ff−75b 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− Sec. 300ff−75b. Administrative simplification regarding parts A and B −STATUTE− (a) Coordinated disbursement After consultation with the States, with eligible areas under part A of this subchapter, and with entities that receive amounts from grants under part A or B of this subchapter, the Secretary
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shall develop a plan for coordinating the disbursement of appropriations for grants under part A of this subchapter with the disbursement of appropriations for grants under part B of this subchapter in order to assist grantees and other recipients of amounts from such grants in complying with the requirements of such parts. The Secretary shall submit the plan to the Congress not later than 18 months after October 20, 2000. Not later than 2 years after the date on which the plan is so submitted, the Secretary shall complete the implementation of the plan, notwithstanding any provision of this subchapter that is inconsistent with the plan. (b) Biennial applications After consultation with the States, with eligible areas under part A of this subchapter, and with entities that receive amounts from grants under part A or B of this subchapter, the Secretary shall make a determination of whether the administration of parts A and B of this subchapter by the Secretary, and the efficiency of grantees under such parts in complying with the requirements of such parts, would be improved by requiring that applications for grants under such parts be submitted biennially rather than annually. The Secretary shall submit such determination to the Congress not later than 2 years after October 20, 2000. (c) Application simplification After consultation with the States, with eligible areas under part A of this subchapter, and with entities that receive amounts from grants under part A or B of this subchapter, the Secretary shall develop a plan for simplifying the process for applications
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under parts A and B of this subchapter. The Secretary shall submit the plan to the Congress not later than 18 months after October 20, 2000. Not later than 2 years after the date on which the plan is so submitted, the Secretary shall complete the implementation of the plan, notwithstanding any provision of this subchapter that is inconsistent with the plan. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2675B, as added Pub. L. 106−345, title IV, Sec. 416, Oct. 20, 2000, 114 Stat. 1351.) −End− −CITE− 42 USC Sec. 300ff−76 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− Sec. 300ff−76. Definitions −STATUTE− For purposes of this subchapter: (1) Counseling The term "counseling" means such counseling provided by an individual trained to provide such counseling. (2) Designated officer of emergency response employees The term "designated officer of emergency response employees"
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means an individual designated under section 300ff−86 of this title by the public health officer of the State involved. (3) Emergency The term "emergency" means an emergency involving injury or illness. (4) Emergency response employees The term "emergency response employees" means firefighters, law enforcement officers, paramedics, emergency medical technicians, funeral−service practitioners, and other individuals (including employees of legally organized and recognized volunteer organizations, without regard to whether such employees receive nominal compensation) who, in the course of professional duties, respond to emergencies in the geographic area involved. (5) Employer of emergency response employees The term "employer of emergency response employees" means an organization that, in the course of professional duties, responds to emergencies in the geographic area involved. (6) Exposed The term "exposed", with respect to HIV disease or any other infectious disease, means to be in circumstances in which there is a significant risk of becoming infected with the etiologic agent for the disease involved. (7) Families with HIV disease The term "families with HIV disease" means families in which one or more members have HIV disease. (8) HIV
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The term "HIV" means infection with the etiologic agent for acquired immune deficiency syndrome. (9) HIV disease The term "HIV disease" means infection with the etiologic agent for acquired immune deficiency syndrome, and includes any condition arising from such syndrome. (10) Official poverty line The term "official poverty line" means the poverty line established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 9902(2) of this title. (11) Person The term "person" includes one or more individuals, governments (including the Federal Government and the governments of the States), governmental agencies, political subdivisions, labor unions, partnerships, associations, corporations, legal representatives, mutual companies, joint−stock companies, trusts, unincorporated organizations, receivers, trustees, and trustees in cases under title 11. (12) State The term "State", except as otherwise specifically provided, means each of the 50 States, the District of Columbia, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Puerto Rico, and the Republic of the Marshall Islands. −SOURCE−
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(July 1, 1944, ch. 373, title XXVI, Sec. 2676, as added Pub. L. 101−381, title IV, Sec. 401, Aug. 18, 1990, 104 Stat. 620; amended Pub. L. 104−146, Sec. 12(a), (c)(8), May 20, 1996, 110 Stat. 1373, 1374.) −MISC1− AMENDMENTS 1996 − Par. (2). Pub. L. 104−146, Sec. 12(c)(8)(A), substituted "section 300ff−86 of this title by the" for "section" and all that followed through "by the". Par. (4). Pub. L. 104−146, Sec. 12(a), inserted "funeral−service practitioners," after "emergency medical technicians,". Par. (10). Pub. L. 104−146, Sec. 12(c)(8)(B), substituted "section 9902(2)" for "section 9902(a)". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−77 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD−
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Sec. 300ff−77. Authorization of appropriations −STATUTE− (a) Part A For the purpose of carrying out part A of this subchapter, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. (b) Part B For the purpose of carrying out part B of this subchapter, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2677, as added Pub. L. 104−146, Sec. 6(a), May 20, 1996, 110 Stat. 1367; amended Pub. L. 106−345, title IV, Sec. 417, Oct. 20, 2000, 114 Stat. 1352.) −MISC1− AMENDMENTS 2000 − Pub. L. 106−345 amended section catchline and text generally, substituting provisions authorizing appropriations for parts A and B of this subchapter for fiscal years 2001 through 2005 for provisions authorizing appropriations to make grants under parts A and B of this subchapter for fiscal years 1996 through 2000 and directing the Secretary to develop a methodology, to be implemented if possible, for adjusting allocations to account for grants to new eligible areas under part A of this subchapter and other relevant factors and to report to Congress on the methodology.
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EFFECTIVE DATE Section effective May 20, 1996, see section 13(b) of Pub. L. 104−146, set out as an Effective Date of 1996 Amendment note under section 300ff−11 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−13, 300ff−15, 300ff−16, 300ff−28, 300ff−30, 300ff−33 of this title. −End− −CITE− 42 USC Sec. 300ff−78 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part D − General Provisions −HEAD− Sec. 300ff−78. Prohibition on promotion of certain activities −STATUTE− None of the funds authorized under this subchapter shall be used to fund AIDS programs, or to develop materials, designed to promote or encourage, directly, intravenous drug use or sexual activity, whether homosexual or heterosexual. Funds authorized under this subchapter may be used to provide medical treatment and support services for individuals with HIV. −SOURCE−
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(July 1, 1944, ch. 373, title XXVI, Sec. 2678, as added Pub. L. 104−146, Sec. 10, May 20, 1996, 110 Stat. 1373.) −MISC1− EFFECTIVE DATE Section effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as an Effective Date of 1996 Amendment note under section 300ff−11 of this title. −End− −CITE− 42 USC Part E − Emergency Response Employees 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees −HEAD− PART E − EMERGENCY RESPONSE EMPLOYEES −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in section 300ff−12 of this title. −End− −CITE− 42 USC subpart i − guidelines and model curriculum 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE
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SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart i − guidelines and model curriculum −HEAD− SUBPART I − GUIDELINES AND MODEL CURRICULUM −MISC1− AMENDMENTS 1996 − Pub. L. 104−146, Sec. 12(c)(9), May 20, 1996, 110 Stat. 1374, made technical amendment to subpart heading. −End− −CITE− 42 USC Sec. 300ff−80 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart i − guidelines and model curriculum −HEAD− Sec. 300ff−80. Grants for implementation −STATUTE− (a) In general With respect to the recommendations contained in the guidelines and the model curriculum developed under section 300ee−2 of this title, the Secretary shall make grants to States and political subdivisions of States for the purpose of assisting grantees
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regarding the initial implementation of such portions of the recommendations as are applicable to emergency response employees. (b) Requirement of application The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. (c) 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 1991 through 1995. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2680, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 622.) −MISC1− EFFECTIVE DATE Section 411(b) of Pub. L. 101−381 provided that: "Sections 2680 and 2681 of part E of title XXVI of the Public Health Service Act [sections 300ff−80 and 300ff−81 of this title], as added by subsection (a) of this section, shall take effect upon the date of the enactment of this Act [Aug. 18, 1990]. Such part shall otherwise take effect upon the expiration of the 30−day period beginning on the date on which the Secretary issues guidelines under section 2681(a)."
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−End− −CITE− 42 USC subpart ii − notifications of possible exposure to infectious diseases 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− SUBPART II − NOTIFICATIONS OF POSSIBLE EXPOSURE TO INFECTIOUS DISEASES −MISC1− AMENDMENTS 1996 − Pub. L. 104−146, Sec. 12(c)(9), May 20, 1996, 110 Stat. 1374, made technical amendment to heading. −End− −CITE− 42 USC Sec. 300ff−81 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees
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subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−81. Infectious diseases and circumstances relevant to notification requirements −STATUTE− (a) In general Not later than 180 days after August 18, 1990, the Secretary shall complete the development of − (1) a list of potentially life−threatening infectious diseases to which emergency response employees may be exposed in responding to emergencies; (2) guidelines describing the circumstances in which such employees may be exposed to such diseases, taking into account the conditions under which emergency response is provided; and (3) guidelines describing the manner in which medical facilities should make determinations for purposes of section 300ff−83(d) of this title. (b) Specification of airborne infectious diseases The list developed by the Secretary under subsection (a)(1) of this section shall include a specification of those infectious diseases on the list that are routinely transmitted through airborne or aerosolized means. (c) Dissemination The Secretary shall − (1) transmit to State public health officers copies of the list
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and guidelines developed by the Secretary under subsection (a) of this section with the request that the officers disseminate such copies as appropriate throughout the States; and (2) make such copies available to the public. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2681, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 623.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ff−83 of this title. −End− −CITE− 42 USC Sec. 300ff−82 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−82. Routine notifications with respect to airborne infectious diseases in victims assisted −STATUTE− (a) Routine notification of designated officer (1) Determination by treating facility
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If a victim of an emergency is transported by emergency response employees to a medical facility and the medical facility makes a determination that the victim has an airborne infectious disease, the medical facility shall notify the designated officer of the emergency response employees who transported the victim to the medical facility of the determination. (2) Determination by facility ascertaining cause of death If a victim of an emergency is transported by emergency response employees to a medical facility and the victim dies at or before reaching the medical facility, the medical facility ascertaining the cause of death shall notify the designated officer of the emergency response employees who transported the victim to the initial medical facility of any determination by the medical facility that the victim had an airborne infectious disease. (b) Requirement of prompt notification With respect to a determination described in paragraph (1) or (2), the notification required in each of such paragraphs shall be made as soon as is practicable, but not later than 48 hours after the determination is made. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2682, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 623.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−84, 300ff−85 of
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this title. −End− −CITE− 42 USC Sec. 300ff−83 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−83. Request for notifications with respect to victims assisted −STATUTE− (a) Initiation of process by employee If an emergency response employee believes that the employee may have been exposed to an infectious disease by a victim of an emergency who was transported to a medical facility as a result of the emergency, and if the employee attended, treated, assisted, or transported the victim pursuant to the emergency, then the designated officer of the employee shall, upon the request of the employee, carry out the duties described in subsection (b) of this section regarding a determination of whether the employee may have been exposed to an infectious disease by the victim. (b) Initial determination by designated officer
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The duties referred to in subsection (a) of this section are that − (1) the designated officer involved collect the facts relating to the circumstances under which, for purposes of subsection (a) of this section, the employee involved may have been exposed to an infectious disease; and (2) the designated officer evaluate such facts and make a determination of whether, if the victim involved had any infectious disease included on the list issued under paragraph (1) of section 300ff−81(a) of this title, the employee would have been exposed to the disease under such facts, as indicated by the guidelines issued under paragraph (2) of such section. (c) Submission of request to medical facility (1) In general If a designated officer makes a determination under subsection (b)(2) of this section that an emergency response employee may have been exposed to an infectious disease, the designated officer shall submit to the medical facility to which the victim involved was transported a request for a response under subsection (d) of this section regarding the victim of the emergency involved. (2) Form of request A request under paragraph (1) shall be in writing and be signed by the designated officer involved, and shall contain a statement of the facts collected pursuant to subsection (b)(1) of this section.
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(d) Evaluation and response regarding request to medical facility (1) In general If a medical facility receives a request under subsection (c) of this section, the medical facility shall evaluate the facts submitted in the request and make a determination of whether, on the basis of the medical information possessed by the facility regarding the victim involved, the emergency response employee was exposed to an infectious disease included on the list issued under paragraph (1) of section 300ff−81(a) of this title, as indicated by the guidelines issued under paragraph (2) of such section. (2) Notification of exposure If a medical facility makes a determination under paragraph (1) that the emergency response employee involved has been exposed to an infectious disease, the medical facility shall, in writing, notify the designated officer who submitted the request under subsection (c) of this section of the determination. (3) Finding of no exposure If a medical facility makes a determination under paragraph (1) that the emergency response employee involved has not been exposed to an infectious disease, the medical facility shall, in writing, inform the designated officer who submitted the request under subsection (c) of this section of the determination. (4) Insufficient information (A) If a medical facility finds in evaluating facts for purposes of paragraph (1) that the facts are insufficient to make
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the determination described in such paragraph, the medical facility shall, in writing, inform the designated officer who submitted the request under subsection (c) of this section of the insufficiency of the facts. (B)(i) If a medical facility finds in making a determination under paragraph (1) that the facility possesses no information on whether the victim involved has an infectious disease included on the list under section 300ff−81(a) of this title, the medical facility shall, in writing, inform the designated officer who submitted the request under subsection (c) of this section of the insufficiency of such medical information. (ii) If after making a response under clause (i) a medical facility determines that the victim involved has an infectious disease, the medical facility shall make the determination described in paragraph (1) and provide the applicable response specified in this subsection. (e) Time for making response After receiving a request under subsection (c) of this section (including any such request resubmitted under subsection (g)(2) of this section), a medical facility shall make the applicable response specified in subsection (d) of this section as soon as is practicable, but not later than 48 hours after receiving the request. (f) Death of victim of emergency (1) Facility ascertaining cause of death If a victim described in subsection (a) of this section dies at
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or before reaching the medical facility involved, and the medical facility receives a request under subsection (c) of this section, the medical facility shall provide a copy of the request to the medical facility ascertaining the cause of death of the victim, if such facility is a different medical facility than the facility that received the original request. (2) Responsibility of facility Upon the receipt of a copy of a request for purposes of paragraph (1), the duties otherwise established in this subpart regarding medical facilities shall apply to the medical facility ascertaining the cause of death of the victim in the same manner and to the same extent as such duties apply to the medical facility originally receiving the request. (g) Assistance of public health officer (1) Evaluation of response of medical facility regarding insufficient facts (A) In the case of a request under subsection (c) of this section to which a medical facility has made the response specified in subsection (d)(4)(A) of this section regarding the insufficiency of facts, the public health officer for the community in which the medical facility is located shall evaluate the request and the response, if the designated officer involved submits such documents to the officer with the request that the officer make such an evaluation. (B) As soon as is practicable after a public health officer receives a request under paragraph (1), but not later than 48
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hours after receipt of the request, the public health officer shall complete the evaluation required in such paragraph and inform the designated officer of the results of the evaluation. (2) Findings of evaluation (A) If an evaluation under paragraph (1)(A) indicates that the facts provided to the medical facility pursuant to subsection (c) of this section were sufficient for purposes of determinations under subsection (d)(1) of this section − (i) the public health officer shall, on behalf of the designated officer involved, resubmit the request to the medical facility; and (ii) the medical facility shall provide to the designated officer the applicable response specified in subsection (d) of this section. (B) If an evaluation under paragraph (1)(A) indicates that the facts provided in the request to the medical facility were insufficient for purposes of determinations specified in subsection (c) of this section − (i) the public health officer shall provide advice to the designated officer regarding the collection and description of appropriate facts; and (ii) if sufficient facts are obtained by the designated officer − (I) the public health officer shall, on behalf of the designated officer involved, resubmit the request to the medical facility; and
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(II) the medical facility shall provide to the designated officer the appropriate response under subsection (c) of this section. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2683, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 624.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300ff−81, 300ff−84, 300ff−85, 300ff−87 of this title. −End− −CITE− 42 USC Sec. 300ff−84 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−84. Procedures for notification of exposure −STATUTE− (a) Contents of notification to officer In making a notification required under section 300ff−82 of this title or section 300ff−83(d)(2) of this title, a medical facility
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shall provide − (1) the name of the infectious disease involved; and (2) the date on which the victim of the emergency involved was transported by emergency response employees to the medical facility involved. (b) Manner of notification If a notification under section 300ff−82 of this title or section 300ff−83(d)(2) of this title is mailed or otherwise indirectly made − (1) the medical facility sending the notification shall, upon sending the notification, inform the designated officer to whom the notification is sent of the fact that the notification has been sent; and (2) such designated officer shall, not later than 10 days after being informed by the medical facility that the notification has been sent, inform such medical facility whether the designated officer has received the notification. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2684, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 626; amended Pub. L. 104−146, Sec. 12(c)(10), May 20, 1996, 110 Stat. 1374.) −MISC1− AMENDMENTS 1996 − Subsec. (b). Pub. L. 104−146 substituted "section 300ff−83(d)(2)" for "section 300ff−82(d)(2)" in introductory
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provisions. EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. −End− −CITE− 42 USC Sec. 300ff−85 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−85. Notification of employee −STATUTE− (a) In general After receiving a notification for purposes of section 300ff−82 or 300ff−83(d)(2) of this title, a designated officer of emergency response employees shall, to the extent practicable, immediately notify each of such employees who − (1) responded to the emergency involved; and (2) as indicated by guidelines developed by the Secretary, may have been exposed to an infectious disease.
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(b) Certain contents of notification to employee A notification under this subsection to an emergency response employee shall inform the employee of − (1) the fact that the employee may have been exposed to an infectious disease and the name of the disease involved; (2) any action by the employee that, as indicated by guidelines developed by the Secretary, is medically appropriate; and (3) if medically appropriate under such criteria, the date of such emergency. (c) Responses other than notification of exposure After receiving a response under paragraph (3) or (4) of subsection (d) of section 300ff−83 of this title, or a response under subsection (g)(1) of such section, the designated officer for the employee shall, to the extent practicable, immediately inform the employee of the response. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2685, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 626.) −End− −CITE− 42 USC Sec. 300ff−86 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees
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subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−86. Selection of designated officers −STATUTE− (a) In general For the purposes of receiving notifications and responses and making requests under this subpart on behalf of emergency response employees, the public health officer of each State shall designate 1 official or officer of each employer of emergency response employees in the State. (b) Preference in making designations In making the designations required in subsection (a) of this section, a public health officer shall give preference to individuals who are trained in the provision of health care or in the control of infectious diseases. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2686, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 627.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300ff−76 of this title. −End− −CITE− 42 USC Sec. 300ff−87 01/06/03 −EXPCITE−
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TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−87. Limitations with respect to duties of medical facilities −STATUTE− The duties established in this subpart for a medical facility − (1) shall apply only to medical information possessed by the facility during the period in which the facility is treating the victim for conditions arising from the emergency, or during the 60−day period beginning on the date on which the victim is transported by emergency response employees to the facility, whichever period expires first; and (2) shall not apply to any extent after the expiration of the 30−day period beginning on the expiration of the applicable period referred to in paragraph (1), except that such duties shall apply with respect to any request under section 300ff−83(c) of this title received by a medical facility before the expiration of such 30−day period. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2687, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 627.)
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−End− −CITE− 42 USC Sec. 300ff−88 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−88. Rules of construction −STATUTE− (a) Liability of medical facilities and designated officers This subpart may not be construed to authorize any cause of action for damages or any civil penalty against any medical facility, or any designated officer, for failure to comply with the duties established in this subpart. (b) Testing This subpart may not, with respect to victims of emergencies, be construed to authorize or require a medical facility to test any such victim for any infectious disease. (c) Confidentiality This subpart may not be construed to authorize or require any medical facility, any designated officer of emergency response employees, or any such employee, to disclose identifying
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information with respect to a victim of an emergency or with respect to an emergency response employee. (d) Failure to provide emergency services This subpart may not be construed to authorize any emergency response employee to fail to respond, or to deny services, to any victim of an emergency. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2688, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 627.) −End− −CITE− 42 USC Sec. 300ff−89 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−89. Injunctions regarding violation of prohibition −STATUTE− (a) In general The Secretary may, in any court of competent jurisdiction, commence a civil action for the purpose of obtaining temporary or permanent injunctive relief with respect to any violation of this
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subpart. (b) Facilitation of information on violations The Secretary shall establish an administrative process for encouraging emergency response employees to provide information to the Secretary regarding violations of this subpart. As appropriate, the Secretary shall investigate alleged such violations and seek appropriate injunctive relief. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2689, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 628.) −End− −CITE− 42 USC Sec. 300ff−90 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part E − Emergency Response Employees subpart ii − notifications of possible exposure to infectious diseases −HEAD− Sec. 300ff−90. Applicability of subpart −STATUTE− This subpart shall not apply in a State if the chief executive officer of the State certifies to the Secretary that the law of the State is in substantial compliance with this subpart.
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−SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2690, as added Pub. L. 101−381, title IV, Sec. 411(a), Aug. 18, 1990, 104 Stat. 628.) −End− −CITE− 42 USC Part F − Demonstration and Training 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part F − Demonstration and Training −HEAD− PART F − DEMONSTRATION AND TRAINING −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in section 300ff−12 of this title. −End− −CITE− 42 USC subpart i − special projects of national significance 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part F − Demonstration and Training subpart i − special projects of national significance
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−HEAD− SUBPART I − SPECIAL PROJECTS OF NATIONAL SIGNIFICANCE −End− −CITE− 42 USC Sec. 300ff−101 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part F − Demonstration and Training subpart i − special projects of national significance −HEAD− Sec. 300ff−101. Special projects of national significance −STATUTE− (a) In general Of the amount appropriated under each of parts A, B, C, and D of this subchapter for each fiscal year, the Secretary shall use the greater of $20,000,000 or 3 percent of such amount appropriated under each such part, but not to exceed $25,000,000, to administer a special projects of national significance program to award direct grants to public and nonprofit private entities including community−based organizations to fund special programs for the care and treatment of individuals with HIV disease. (b) Grants The Secretary shall award grants under subsection (a) of this section based on −
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(1) the need to assess the effectiveness of a particular model for the care and treatment of individuals with HIV disease; (2) the innovative nature of the proposed activity; and (3) the potential replicability of the proposed activity in other similar localities or nationally. (c) Special projects Special projects of national significance shall include the development and assessment of innovative service delivery models that are designed to − (1) address the needs of special populations; (2) assist in the development of essential community−based service delivery infrastructure; and (3) ensure the ongoing availability of services for Native American communities to enable such communities to care for Native Americans with HIV disease. (d) Special populations Special projects of national significance may include the delivery of HIV health care and support services to traditionally underserved populations including − (1) individuals and families with HIV disease living in rural communities; (2) adolescents with HIV disease; (3) Indian individuals and families with HIV disease; (4) homeless individuals and families with HIV disease; (5) hemophiliacs with HIV disease; and (6) incarcerated individuals with HIV disease.
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(e) Service development grants Special projects of national significance may include the development of model approaches to delivering HIV care and support services including − (1) programs that support family−based care networks and programs that build organizational capacity critical to the delivery of care in minority communities; (2) programs designed to prepare AIDS service organizations and grantees under this subchapter for operation within the changing health care environment; and (3) programs designed to integrate the delivery of mental health and substance abuse treatment with HIV services. (f) Coordination The Secretary may not make a grant under this section unless the applicant submits evidence that the proposed program is consistent with the statewide coordinated statement of need, and the applicant agrees to participate in the ongoing revision process of such statement of need. (g) Replication The Secretary shall make information concerning successful models developed under this part available to grantees under this subchapter for the purpose of coordination, replication, and integration. To facilitate efforts under this subsection, the Secretary may provide for peer−based technical assistance from grantees funded under this part. −SOURCE−
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(July 1, 1944, ch. 373, title XXVI, Sec. 2691, as added Pub. L. 104−146, Sec. 3(g)(1), May 20, 1996, 110 Stat. 1362.) −MISC1− EFFECTIVE DATE For effective date, see section 13 of Pub. L. 104−146, set out as an Effective Date of 1996 Amendment note under section 300ff−11 of this title. −End− −CITE− 42 USC subpart ii − aids education and training centers 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part F − Demonstration and Training subpart ii − aids education and training centers −HEAD− SUBPART II − AIDS EDUCATION AND TRAINING CENTERS −End− −CITE− 42 USC Sec. 300ff−111 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXIV − HIV HEALTH CARE SERVICES PROGRAM Part F − Demonstration and Training
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subpart ii − aids education and training centers −HEAD− Sec. 300ff−111. HIV/AIDS communities, schools, and centers −STATUTE− (a) Schools; centers (1) In general The Secretary may make grants and enter into contracts to assist public and nonprofit private entities and schools and academic health science centers in meeting the costs of projects − (A) to train health personnel, including practitioners in programs under this subchapter and other community providers, in the diagnosis, treatment, and prevention of HIV disease, including the prevention of the perinatal transmission of the disease, including measures for the prevention and treatment of opportunistic infections, and including (as applicable to the type of health professional involved), prenatal and other gynecological care for women with HIV disease; (B) to train the faculty of schools of, and graduate departments or programs of, medicine, nursing, osteopathic medicine, dentistry, public health, allied health, and mental health practice to teach health professions students to provide for the health care needs of individuals with HIV disease; (C) to develop and disseminate curricula and resource materials relating to the care and treatment of individuals with such disease and the prevention of the disease among
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individuals who are at risk of contracting the disease; and (D) to develop protocols for the medical care of women with HIV disease, including prenatal and other gynecological care for such women. (2) Preference in making grants In making grants under paragraph (1), the Secretary shall give preference to qualified projects which will − (A) train, or result in the training of, health professionals who will provide treatment for minority individuals with HIV disease and other individuals who are at high risk of contracting such disease; and (B) train, or result in the training of, minority health professionals and minority allied health professionals to provide treatment for individuals with such disease. (3) Application No grant or contract may be made under paragraph (1) unless an application is submitted to the Secretary in such form, at such time, and containing such information, as the Secretary may prescribe. (b) Dental schools (1) In general (A) Grants The Secretary may make grants to dental schools and programs described in subparagraph (B) to assist such schools and programs with respect to oral health care to patients with HIV disease.
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(B) Eligible applicants For purposes of this subsection, the dental schools and programs referred to in this subparagraph are dental schools and programs that were described in section 294o(b)(4)(B) of this title as such section was in effect on the day before November 13, 1998, and in addition dental hygiene programs that are accredited by the Commission on Dental Accreditation. (2) Application Each dental school or program described in section (!1) the section referred to in paragraph (1)(B) may annually submit an application documenting the unreimbursed costs of oral health care provided to patients with HIV disease by that school or hospital during the prior year. (3) Distribution The Secretary shall distribute the available funds among all eligible applicants, taking into account the number of patients with HIV disease served and the unreimbursed oral health care costs incurred by each institution as compared with the total number of patients served and costs incurred by all eligible applicants. (4) Maintenance of effort The Secretary shall not make a grant under this subsection if doing so would result in any reduction in State funding allotted for such purposes. (5) Community−based care The Secretary may make grants to dental schools and programs
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described in paragraph (1)(B) that partner with community−based dentists to provide oral health care to patients with HIV disease in unserved areas. Such partnerships shall permit the training of dental students and residents and the participation of community dentists as adjunct faculty. (c) Authorization of appropriations (1) Schools; centers For the purpose of grants under subsection (a) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. (2) Dental schools (A) In general For the purpose of grants under paragraphs (1) through (4) of subsection (b) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. (B) Community−based care For the purpose of grants under subsection (b)(5) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. −SOURCE− (July 1, 1944, ch. 373, title XXVI, Sec. 2692, formerly title VII, Sec. 776, as added Pub. L. 102−408, title I, Sec. 102, Oct. 13, 1992, 106 Stat. 2050; amended Pub. L. 102−531, title III, Sec. 313(a)(4), Oct. 27, 1992, 106 Stat. 3507; renumbered title XXVI,
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Sec. 2692, and amended Pub. L. 104−146, Sec. 3(h), May 20, 1996, 110 Stat. 1363; Pub. L. 104−166, Sec. 5(2), July 29, 1996, 110 Stat. 1449; Pub. L. 106−345, title IV, Sec. 402(a)(1), (b), (c), Oct. 20, 2000, 114 Stat. 1348, 1349.) −COD− CODIFICATION Section was formerly classified to section 294n of this title prior to renumbering by Pub. L. 104−146. −MISC1− AMENDMENTS 2000 − Subsec. (a)(1)(A). Pub. L. 106−345, Sec. 402(a)(1)(A), substituted "to train" for "training", substituted ", including" for "and including" after "transmission of the disease", and inserted ", and including (as applicable to the type of health professional involved), prenatal and other gynecological care for women with HIV disease" before semicolon at end. Subsec. (a)(1)(D). Pub. L. 106−345, Sec. 402(a)(1)(B)−(D), added subpar. (D). Subsec. (b)(1). Pub. L. 106−345, Sec. 402(b)(1), amended heading and text of par. (1) generally. Prior to amendment, text read as follows: "The Secretary may make grants to assist dental schools and programs described in section 294o(b)(4)(B) of this title with respect to oral health care to patients with HIV disease." Subsec. (b)(2). Pub. L. 106−345, Sec. 402(b)(2), substituted "the section referred to in paragraph (1)(B)" for "294o(b)(4)(B) of this title".
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Subsec. (b)(5). Pub. L. 106−345, Sec. 402(b)(3), added par. (5). Subsec. (c)(1). Pub. L. 106−345, Sec. 402(c)(1), substituted "fiscal years 2001 through 2005" for "fiscal years 1996 through 2000". Subsec. (c)(2). Pub. L. 106−345, Sec. 402(c)(2), amended heading and text of par. (2) generally. Prior to amendment, text read as follows: "For the purpose of grants under subsection (b) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1996 through 2000." 1996 − Pub. L. 104−146, Sec. 3(h)(1), (2)(A), substituted "HIV/AIDS communities, schools, and centers" for "Acquired immune deficiency syndrome" as section catchline. Subsec. (a)(1)(A). Pub. L. 104−166, Sec. 5(2)(A), substituted "in programs under this subchapter" for "in subchapter XXIV programs" and struck out "infection and" after "prevention of HIV". Pub. L. 104−146, Sec. 3(h)(2)(B)(iii), added subpar. (A). Former subpar. (A) redesignated (B). Subsec. (a)(1)(B). Pub. L. 104−146, Sec. 3(h)(2)(B)(iv), inserted "and" after semicolon. Pub. L. 104−146, Sec. 3(h)(2)(B)(i), (ii), redesignated subpar. (A) as (B) and struck out former subpar. (B) which read as follows: "to train practitioners to provide for the health care needs of such individuals;". Subsec. (a)(1)(C), (D). Pub. L. 104−146, Sec. 3(h)(2)(B)(i), (ii), redesignated subpar. (D) as (C) and struck out former subpar. (C) which read as follows: "with respect to improving clinical
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skills in the diagnosis, treatment, and prevention of such disease, to educate and train the health professionals and clinical staff of schools of medicine, osteopathic medicine, and dentistry; and". Subsec. (c). Pub. L. 104−166, Sec. 5(2)(B), added subsec. (c) and struck out heading and text of former subsec. (c). Text read as follows: "For purposes of this section: "(1) The term 'HIV disease' means infection with the human immunodeficiency virus, and includes any condition arising from such infection. "(2) The term 'human immunodeficiency virus' means the etiologic agent for acquired immune deficiency syndrome." Subsec. (d). Pub. L. 104−166, Sec. 5(2)(B), struck out heading and text of subsec. (d) relating to authorization of appropriations for fiscal years 1996 through 2000. Text read as follows: "There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of the fiscal years 1996 through 2000." Pub. L. 104−166, Sec. 5(2)(B), struck out heading and text of subsec. (d) relating to authorization of appropriations for fiscal years 1993 through 1995. Text read as follows: "(1) Schools; centers. − For the purpose of grants under subsection (a) of this section, there is authorized to be appropriated $23,000,000 for each of the fiscal years 1993 through 1995. "(2) Dental schools. − For the purpose of grants under subsection (b) of this section, there is authorized to be appropriated
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$7,000,000 for each of the fiscal years 1993 through 1995." Pub. L. 104−146, Sec. 3(h)(4), added subsec. (d) relating to authorization of appropriations for fiscal years 1996 through 2000. 1992 − Subsec. (a)(3). Pub. L. 102−531, which directed the substitution of "No grant" for "no grant" in par. (3), could not be executed because the words "no grant" did not appear in par. (3). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−146 effective Oct. 1, 1996, see section 13 of Pub. L. 104−146, set out as a note under section 300ff−11 of this title. EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−531 effective immediately after enactment of Pub. L. 102−408, see section 313(c) of Pub. L. 102−531, set out as a note under section 292y of this title. DISSEMINATION OF TREATMENT GUIDELINES; MEDICAL CONSULTATION ACTIVITIES Pub. L. 106−345, title IV, Sec. 402(a)(2), Oct. 20, 2000, 114 Stat. 1349, provided that: "Not later than 90 days after the date of the enactment of this Act [Oct. 20, 2000], the Secretary of Health and Human Services shall issue and begin implementation of a strategy for the dissemination of HIV treatment information to health care providers and patients." −FOOTNOTE− (!1) So in original. −End− −CITE−
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42 USC SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE −HEAD− SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE −MISC1− AMENDMENTS 1996 − Pub. L. 104−204, title VI, Sec. 604(a)(1), Sept. 26, 1996, 110 Stat. 2938, substituted "REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE" for "ASSURING PORTABILITY, AVAILABILITY, AND RENEWABILITY OF HEALTH INSURANCE COVERAGE" as subchapter heading. −SECREF− SUBCHAPTER REFERRED TO IN OTHER SECTIONS This subchapter is referred to in sections 300bb−2, 1397cc, 1397ii of this title; title 26 sections 4980B, 9805; title 29 section 1162. −End− −CITE− 42 USC Part A − Group Market Reforms 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
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Part A − Group Market Reforms −HEAD− PART A − GROUP MARKET REFORMS −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in title 29 section 1181; title 42 section 300gg−61. −End− −CITE− 42 USC subpart 1 − portability, access, and renewability requirements 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 1 − portability, access, and renewability requirements −HEAD− SUBPART 1 − PORTABILITY, ACCESS, AND RENEWABILITY REQUIREMENTS −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in section 300gg−21 of this title. −End− −CITE− 42 USC Sec. 300gg 01/06/03 −EXPCITE−
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TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 1 − portability, access, and renewability requirements −HEAD− Sec. 300gg. Increased portability through limitation on preexisting condition exclusions −STATUTE− (a) Limitation on preexisting condition exclusion period; crediting for periods of previous coverage Subject to subsection (d) of this section, a group health plan, and a health insurance issuer offering group health insurance coverage, may, with respect to a participant or beneficiary, impose a preexisting condition exclusion only if − (1) such exclusion relates to a condition (whether physical or mental), regardless of the cause of the condition, for which medical advice, diagnosis, care, or treatment was recommended or received within the 6−month period ending on the enrollment date; (2) such exclusion extends for a period of not more than 12 months (or 18 months in the case of a late enrollee) after the enrollment date; and (3) the period of any such preexisting condition exclusion is reduced by the aggregate of the periods of creditable coverage (if any, as defined in subsection (c)(1) of this section) applicable to the participant or beneficiary as of the enrollment
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date. (b) Definitions For purposes of this part − (1) Preexisting condition exclusion (A) In general The term "preexisting condition exclusion" means, with respect to coverage, a limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for such coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before such date. (B) Treatment of genetic information Genetic information shall not be treated as a condition described in subsection (a)(1) of this section in the absence of a diagnosis of the condition related to such information. (2) Enrollment date The term "enrollment date" means, with respect to an individual covered under a group health plan or health insurance coverage, the date of enrollment of the individual in the plan or coverage or, if earlier, the first day of the waiting period for such enrollment. (3) Late enrollee The term "late enrollee" means, with respect to coverage under a group health plan, a participant or beneficiary who enrolls under the plan other than during − (A) the first period in which the individual is eligible to
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enroll under the plan, or (B) a special enrollment period under subsection (f) of this section. (4) Waiting period The term "waiting period" means, with respect to a group health plan and an individual who is a potential participant or beneficiary in the plan, the period that must pass with respect to the individual before the individual is eligible to be covered for benefits under the terms of the plan. (c) Rules relating to crediting previous coverage (1) "Creditable coverage" defined For purposes of this subchapter, the term "creditable coverage" means, with respect to an individual, coverage of the individual under any of the following: (A) A group health plan. (B) Health insurance coverage. (C) Part A or part B of title XVIII of the Social Security Act [42 U.S.C. 1395c et seq., 1395j et seq.]. (D) Title XIX of the Social Security Act [42 U.S.C. 1396 et seq.], other than coverage consisting solely of benefits under section 1928 [42 U.S.C. 1396s]. (E) Chapter 55 of title 10. (F) A medical care program of the Indian Health Service or of a tribal organization. (G) A State health benefits risk pool. (H) A health plan offered under chapter 89 of title 5.
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(I) A public health plan (as defined in regulations). (J) A health benefit plan under section 2504(e) of title 22. Such term does not include coverage consisting solely of coverage of excepted benefits (as defined in section 300gg−91(c) of this title). (2) Not counting periods before significant breaks in coverage (A) In general A period of creditable coverage shall not be counted, with respect to enrollment of an individual under a group health plan, if, after such period and before the enrollment date, there was a 63−day period during all of which the individual was not covered under any creditable coverage. (B) Waiting period not treated as a break in coverage For purposes of subparagraph (A) and subsection (d)(4) of this section, any period that an individual is in a waiting period for any coverage under a group health plan (or for group health insurance coverage) or is in an affiliation period (as defined in subsection (g)(2) of this section) shall not be taken into account in determining the continuous period under subparagraph (A). (3) Method of crediting coverage (A) Standard method Except as otherwise provided under subparagraph (B), for purposes of applying subsection (a)(3) of this section, a group health plan, and a health insurance issuer offering group health insurance coverage, shall count a period of creditable
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coverage without regard to the specific benefits covered during the period. (B) Election of alternative method A group health plan, or a health insurance issuer offering group health insurance, may elect to apply subsection (a)(3) of this section based on coverage of benefits within each of several classes or categories of benefits specified in regulations rather than as provided under subparagraph (A). Such election shall be made on a uniform basis for all participants and beneficiaries. Under such election a group health plan or issuer shall count a period of creditable coverage with respect to any class or category of benefits if any level of benefits is covered within such class or category. (C) Plan notice In the case of an election with respect to a group health plan under subparagraph (B) (whether or not health insurance coverage is provided in connection with such plan), the plan shall − (i) prominently state in any disclosure statements concerning the plan, and state to each enrollee at the time of enrollment under the plan, that the plan has made such election, and (ii) include in such statements a description of the effect of this election. (D) Issuer notice In the case of an election under subparagraph (B) with
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respect to health insurance coverage offered by an issuer in the small or large group market, the issuer − (i) shall prominently state in any disclosure statements concerning the coverage, and to each employer at the time of the offer or sale of the coverage, that the issuer has made such election, and (ii) shall include in such statements a description of the effect of such election. (4) Establishment of period Periods of creditable coverage with respect to an individual shall be established through presentation of certifications described in subsection (e) of this section or in such other manner as may be specified in regulations. (d) Exceptions (1) Exclusion not applicable to certain newborns Subject to paragraph (4), a group health plan, and a health insurance issuer offering group health insurance coverage, may not impose any preexisting condition exclusion in the case of an individual who, as of the last day of the 30−day period beginning with the date of birth, is covered under creditable coverage. (2) Exclusion not applicable to certain adopted children Subject to paragraph (4), a group health plan, and a health insurance issuer offering group health insurance coverage, may not impose any preexisting condition exclusion in the case of a child who is adopted or placed for adoption before attaining 18 years of age and who, as of the last day of the 30−day period
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beginning on the date of the adoption or placement for adoption, is covered under creditable coverage. The previous sentence shall not apply to coverage before the date of such adoption or placement for adoption. (3) Exclusion not applicable to pregnancy A group health plan, and health insurance issuer offering group health insurance coverage, may not impose any preexisting condition exclusion relating to pregnancy as a preexisting condition. (4) Loss if break in coverage Paragraphs (1) and (2) shall no longer apply to an individual after the end of the first 63−day period during all of which the individual was not covered under any creditable coverage. (e) Certifications and disclosure of coverage (1) Requirement for certification of period of creditable coverage (A) In general A group health plan, and a health insurance issuer offering group health insurance coverage, shall provide the certification described in subparagraph (B) − (i) at the time an individual ceases to be covered under the plan or otherwise becomes covered under a COBRA continuation provision, (ii) in the case of an individual becoming covered under such a provision, at the time the individual ceases to be covered under such provision, and
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(iii) on the request on behalf of an individual made not later than 24 months after the date of cessation of the coverage described in clause (i) or (ii), whichever is later. The certification under clause (i) may be provided, to the extent practicable, at a time consistent with notices required under any applicable COBRA continuation provision. (B) Certification The certification described in this subparagraph is a written certification of − (i) the period of creditable coverage of the individual under such plan and the coverage (if any) under such COBRA continuation provision, and (ii) the waiting period (if any) (and affiliation period, if applicable) imposed with respect to the individual for any coverage under such plan. (C) Issuer compliance To the extent that medical care under a group health plan consists of group health insurance coverage, the plan is deemed to have satisfied the certification requirement under this paragraph if the health insurance issuer offering the coverage provides for such certification in accordance with this paragraph. (2) Disclosure of information on previous benefits In the case of an election described in subsection (c)(3)(B) of this section by a group health plan or health insurance issuer, if the plan or issuer enrolls an individual for coverage under
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the plan and the individual provides a certification of coverage of the individual under paragraph (1) − (A) upon request of such plan or issuer, the entity which issued the certification provided by the individual shall promptly disclose to such requesting plan or issuer information on coverage of classes and categories of health benefits available under such entity's plan or coverage, and (B) such entity may charge the requesting plan or issuer for the reasonable cost of disclosing such information. (3) Regulations The Secretary shall establish rules to prevent an entity's failure to provide information under paragraph (1) or (2) with respect to previous coverage of an individual from adversely affecting any subsequent coverage of the individual under another group health plan or health insurance coverage. (f) Special enrollment periods (1) Individuals losing other coverage A group health plan, and a health insurance issuer offering group health insurance coverage in connection with a group health plan, shall permit an employee who is eligible, but not enrolled, for coverage under the terms of the plan (or a dependent of such an employee if the dependent is eligible, but not enrolled, for coverage under such terms) to enroll for coverage under the terms of the plan if each of the following conditions is met: (A) The employee or dependent was covered under a group health plan or had health insurance coverage at the time
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coverage was previously offered to the employee or dependent. (B) The employee stated in writing at such time that coverage under a group health plan or health insurance coverage was the reason for declining enrollment, but only if the plan sponsor or issuer (if applicable) required such a statement at such time and provided the employee with notice of such requirement (and the consequences of such requirement) at such time. (C) The employee's or dependent's coverage described in subparagraph (A) − (i) was under a COBRA continuation provision and the coverage under such provision was exhausted; or (ii) was not under such a provision and either the coverage was terminated as a result of loss of eligibility for the coverage (including as a result of legal separation, divorce, death, termination of employment, or reduction in the number of hours of employment) or employer contributions toward such coverage were terminated. (D) Under the terms of the plan, the employee requests such enrollment not later than 30 days after the date of exhaustion of coverage described in subparagraph (C)(i) or termination of coverage or employer contribution described in subparagraph (C)(ii). (2) For dependent beneficiaries (A) In general If − (i) a group health plan makes coverage available with
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respect to a dependent of an individual, (ii) the individual is a participant under the plan (or has met any waiting period applicable to becoming a participant under the plan and is eligible to be enrolled under the plan but for a failure to enroll during a previous enrollment period), and (iii) a person becomes such a dependent of the individual through marriage, birth, or adoption or placement for adoption, the group health plan shall provide for a dependent special enrollment period described in subparagraph (B) during which the person (or, if not otherwise enrolled, the individual) may be enrolled under the plan as a dependent of the individual, and in the case of the birth or adoption of a child, the spouse of the individual may be enrolled as a dependent of the individual if such spouse is otherwise eligible for coverage. (B) Dependent special enrollment period A dependent special enrollment period under this subparagraph shall be a period of not less than 30 days and shall begin on the later of − (i) the date dependent coverage is made available, or (ii) the date of the marriage, birth, or adoption or placement for adoption (as the case may be) described in subparagraph (A)(iii). (C) No waiting period If an individual seeks to enroll a dependent during the first
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30 days of such a dependent special enrollment period, the coverage of the dependent shall become effective − (i) in the case of marriage, not later than the first day of the first month beginning after the date the completed request for enrollment is received; (ii) in the case of a dependent's birth, as of the date of such birth; or (iii) in the case of a dependent's adoption or placement for adoption, the date of such adoption or placement for adoption. (g) Use of affiliation period by HMOs as alternative to preexisting condition exclusion (1) In general A health maintenance organization which offers health insurance coverage in connection with a group health plan and which does not impose any preexisting condition exclusion allowed under subsection (a) of this section with respect to any particular coverage option may impose an affiliation period for such coverage option, but only if − (A) such period is applied uniformly without regard to any health status−related factors; and (B) such period does not exceed 2 months (or 3 months in the case of a late enrollee). (2) Affiliation period (A) "Affiliation period" defined For purposes of this subchapter, the term "affiliation
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period" means a period which, under the terms of the health insurance coverage offered by the health maintenance organization, must expire before the health insurance coverage becomes effective. The organization is not required to provide health care services or benefits during such period and no premium shall be charged to the participant or beneficiary for any coverage during the period. (B) Beginning Such period shall begin on the enrollment date. (C) Runs concurrently with waiting periods An affiliation period under a plan shall run concurrently with any waiting period under the plan. (3) Alternative methods A health maintenance organization described in paragraph (1) may use alternative methods, from those described in such paragraph, to address adverse selection as approved by the State insurance commissioner or official or officials designated by the State to enforce the requirements of this part for the State involved with respect to such issuer. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2701, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1955.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in subsec. (c)(1)(C), (D), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Parts A
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and B of title XVIII of the Act are classified generally to parts A (Sec. 1395c et seq.) and B (Sec. 1395j et seq.) of subchapter XVIII of chapter 7 of this title. Title XIX of the Act is classified generally to subchapter XIX (Sec. 1396 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. −MISC1− PRIOR PROVISIONS A prior section 2701 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238 of this title. EFFECTIVE DATE Section 102(c) of Pub. L. 104−191 provided that: "(1) In general. − Except as provided in this subsection, part A of title XXVII of the Public Health Service Act [this part] (as added by subsection (a)) shall apply with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997. "(2) Determination of creditable coverage. − "(A) Period of coverage. − "(i) In general. − Subject to clause (ii), no period before July 1, 1996, shall be taken into account under part A of title XXVII of the Public Health Service Act [this part] (as added by this section) in determining creditable coverage. "(ii) Special rule for certain periods. − The Secretary of Health and Human Services, consistent with section 104 [set out
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as a note under section 300gg−92 of this title], shall provide for a process whereby individuals who need to establish creditable coverage for periods before July 1, 1996, and who would have such coverage credited but for clause (i) may be given credit for creditable coverage for such periods through the presentation of documents or other means. "(B) Certifications, etc. − "(i) In general. − Subject to clauses (ii) and (iii), subsection (e) of section 2701 of the Public Health Service Act [subsec. (e) of this section] (as added by this section) shall apply to events occurring after June 30, 1996. "(ii) No certification required to be provided before june 1, 1997. − In no case is a certification required to be provided under such subsection before June 1, 1997. "(iii) Certification only on written request for events occurring before october 1, 1996. − In the case of an event occurring after June 30, 1996, and before October 1, 1996, a certification is not required to be provided under such subsection unless an individual (with respect to whom the certification is otherwise required to be made) requests such certification in writing. "(C) Transitional rule. − In the case of an individual who seeks to establish creditable coverage for any period for which certification is not required because it relates to an event occurring before June 30, 1996 − "(i) the individual may present other credible evidence of
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such coverage in order to establish the period of creditable coverage; and "(ii) a group health plan and a health insurance issuer shall not be subject to any penalty or enforcement action with respect to the plan's or issuer's crediting (or not crediting) such coverage if the plan or issuer has sought to comply in good faith with the applicable requirements under the amendments made by this section [enacting this section and sections 300gg−1, 300gg−11 to 300gg−13, 300gg−21 to 300gg−23, 300gg−91, and 300gg−92 of this title and amending sections 300e and 300bb−8 of this title]. "(3) Special rule for collective bargaining agreements. − Except as provided in paragraph (2)(B), in the case of a group health plan maintained pursuant to 1 or more collective bargaining agreements between employee representatives and one or more employers ratified before the date of the enactment of this Act [Aug. 21, 1996], part A of title XXVII of the Public Health Service Act [this part] (other than section 2701(e) thereof [subsec. (e) of this section]) shall not apply to plan years beginning before the later of − "(A) the date on which the last of the collective bargaining agreements relating to the plan terminates (determined without regard to any extension thereof agreed to after the date of the enactment of this Act), or "(B) July 1, 1997. For purposes of subparagraph (A), any plan amendment made pursuant to a collective bargaining agreement relating to the plan which
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amends the plan solely to conform to any requirement of such part shall not be treated as a termination of such collective bargaining agreement. "(4) Timely regulations. − The Secretary of Health and Human Services, consistent with section 104 [set out as a note under section 300gg−92 of this title], shall first issue by not later than April 1, 1997, such regulations as may be necessary to carry out the amendments made by this section [enacting this section and sections 300gg−1, 300gg−11 to 300gg−13, 300gg−21 to 300gg−23, 300gg−91, and 300gg−92 of this title and amending sections 300e and 300bb−8 of this title] and section 111 [enacting sections 300gg−41 to 300gg−44 and 300gg−61 to 300gg−63 of this title]. "(5) Limitation on actions. − No enforcement action shall be taken, pursuant to the amendments made by this section, against a group health plan or health insurance issuer with respect to a violation of a requirement imposed by such amendments before January 1, 1998, or, if later, the date of issuance of regulations referred to in paragraph (4), if the plan or issuer has sought to comply in good faith with such requirements." CONGRESSIONAL FINDINGS RELATING TO EXERCISE OF COMMERCE CLAUSE AUTHORITY; SEVERABILITY Section 195 of title I of Pub. L. 104−191 provided that: "(a) Findings Relating to Exercise of Commerce Clause Authority. − Congress finds the following in relation to the provisions of this title [enacting this subchapter and sections 1181 to 1183 and 1191 to 1191c of Title 29, Labor, amending sections 233, 300e, and
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300bb−8 of this title and sections 1003, 1021, 1022, 1024, 1132, 1136, and 1144 of Title 29, and enacting provisions set out as notes under this section, section 300gg−92 of this title, and section 1181 of Title 29]: "(1) Provisions in group health plans and health insurance coverage that impose certain preexisting condition exclusions impact the ability of employees to seek employment in interstate commerce, thereby impeding such commerce. "(2) Health insurance coverage is commercial in nature and is in and affects interstate commerce. "(3) It is a necessary and proper exercise of Congressional authority to impose requirements under this title on group health plans and health insurance coverage (including coverage offered to individuals previously covered under group health plans) in order to promote commerce among the States. "(4) Congress, however, intends to defer to States, to the maximum extent practicable, in carrying out such requirements with respect to insurers and health maintenance organizations that are subject to State regulation, consistent with the provisions of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1001 et seq.]. "(b) Severability. − If any provision of this title or the application of such provision to any person or circumstance is held to be unconstitutional, the remainder of this title and the application of the provisions of such to any person or circumstance shall not be affected thereby."
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HEALTH COVERAGE AVAILABILITY STUDIES Section 191 of title I of Pub. L. 104−191 provided that: "(a) Studies. − "(1) Study on effectiveness of reforms. − The Secretary of Health and Human Services shall provide for a study on the effectiveness of the provisions of this title [enacting this subchapter and sections 1181 to 1183 and 1191 to 1191c of Title 29, Labor, amending sections 233, 300e, and 300bb−8 of this title and sections 1003, 1021, 1022, 1024, 1132, 1136, and 1144 of Title 29, and enacting provisions set out as notes under this section, section 300gg−92 of this title, and section 1181 of Title 29] and the various State laws, in ensuring the availability of reasonably priced health coverage to employers purchasing group coverage and individuals purchasing coverage on a non−group basis. "(2) Study on access and choice. − The Secretary also shall provide for a study on − "(A) the extent to which patients have direct access to, and choice of, health care providers, including specialty providers, within a network plan, as well as the opportunity to utilize providers outside of the network plan, under the various types of coverage offered under the provisions of this title; and "(B) the cost and cost−effectiveness to health insurance issuers of providing access to out−of−network providers, and the potential impact of providing such access on the cost and
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quality of health insurance coverage offered under provisions of this title. "(3) Consultation. − The studies under this subsection shall be conducted in consultation with the Secretary of Labor, representatives of State officials, consumers, and other representatives of individuals and entities that have expertise in health insurance and employee benefits. "(b) Reports. − Not later than January 1, 2000, the Secretary shall submit to the appropriate committees of Congress a report on each of the studies under subsection (a)." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300e, 300bb−5, 300gg−1, 300gg−21, 300gg−23, 300gg−41, 300gg−43, 300gg−91, 1395ss, 1396a, 1397jj of this title; title 26 section 4980B; title 29 section 1165. −End− −CITE− 42 USC Sec. 300gg−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 1 − portability, access, and renewability requirements −HEAD−
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Sec. 300gg−1. Prohibiting discrimination against individual participants and beneficiaries based on health status −STATUTE− (a) In eligibility to enroll (1) In general Subject to paragraph (2), a group health plan, and a health insurance issuer offering group health insurance coverage in connection with a group health plan, may not establish rules for eligibility (including continued eligibility) of any individual to enroll under the terms of the plan based on any of the following health status−related factors in relation to the individual or a dependent of the individual: (A) Health status. (B) Medical condition (including both physical and mental illnesses). (C) Claims experience. (D) Receipt of health care. (E) Medical history. (F) Genetic information. (G) Evidence of insurability (including conditions arising out of acts of domestic violence). (H) Disability. (2) No application to benefits or exclusions To the extent consistent with section 300gg (!1) of this title, paragraph (1) shall not be construed − (A) to require a group health plan, or group health insurance
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coverage, to provide particular benefits other than those provided under the terms of such plan or coverage, or (B) to prevent such a plan or coverage from establishing limitations or restrictions on the amount, level, extent, or nature of the benefits or coverage for similarly situated individuals enrolled in the plan or coverage. (3) Construction For purposes of paragraph (1), rules for eligibility to enroll under a plan include rules defining any applicable waiting periods for such enrollment. (b) In premium contributions (1) In general A group health plan, and a health insurance issuer offering health insurance coverage in connection with a group health plan, may not require any individual (as a condition of enrollment or continued enrollment under the plan) to pay a premium or contribution which is greater than such premium or contribution for a similarly situated individual enrolled in the plan on the basis of any health status−related factor in relation to the individual or to an individual enrolled under the plan as a dependent of the individual. (2) Construction Nothing in paragraph (1) shall be construed − (A) to restrict the amount that an employer may be charged for coverage under a group health plan; or (B) to prevent a group health plan, and a health insurance
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issuer offering group health insurance coverage, from establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in return for adherence to programs of health promotion and disease prevention. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2702, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1961.) −REFTEXT− REFERENCES IN TEXT Section 300gg of this title, referred to in subsec. (a)(2), was in the original "section 701" and was translated as reading "section 2701" meaning section 2701 of act July 1, 1944, as added by Pub. L. 104−191, Sec. 102(a), to reflect the probable intent of Congress. −MISC1− PRIOR PROVISIONS A prior section 2702 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238a of this title. EFFECTIVE DATE Section applicable with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997, except as otherwise provided, see section 102(c) of Pub. L. 104−191, set out as a note under section 300gg of this title.
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−SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300gg−11, 300gg−91, 1395w−22, 1395cc−2 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC subpart 2 − other requirements 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 2 − other requirements −HEAD− SUBPART 2 − OTHER REQUIREMENTS −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in sections 300gg−21, 1396u−2, 1397cc of this title. −End− −CITE− 42 USC Sec. 300gg−4 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE
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CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 2 − other requirements −HEAD− Sec. 300gg−4. Standards relating to benefits for mothers and newborns −STATUTE− (a) Requirements for minimum hospital stay following birth (1) In general A group health plan, and a health insurance issuer offering group health insurance coverage, may not − (A) except as provided in paragraph (2) − (i) restrict benefits for any hospital length of stay in connection with childbirth for the mother or newborn child, following a normal vaginal delivery, to less than 48 hours, or (ii) restrict benefits for any hospital length of stay in connection with childbirth for the mother or newborn child, following a cesarean section, to less than 96 hours, or (B) require that a provider obtain authorization from the plan or the issuer for prescribing any length of stay required under subparagraph (A) (without regard to paragraph (2)). (2) Exception Paragraph (1)(A) shall not apply in connection with any group health plan or health insurance issuer in any case in which the
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decision to discharge the mother or her newborn child prior to the expiration of the minimum length of stay otherwise required under paragraph (1)(A) is made by an attending provider in consultation with the mother. (b) Prohibitions A group health plan, and a health insurance issuer offering group health insurance coverage in connection with a group health plan, may not − (1) deny to the mother or her newborn child eligibility, or continued eligibility, to enroll or to renew coverage under the terms of the plan, solely for the purpose of avoiding the requirements of this section; (2) provide monetary payments or rebates to mothers to encourage such mothers to accept less than the minimum protections available under this section; (3) penalize or otherwise reduce or limit the reimbursement of an attending provider because such provider provided care to an individual participant or beneficiary in accordance with this section; (4) provide incentives (monetary or otherwise) to an attending provider to induce such provider to provide care to an individual participant or beneficiary in a manner inconsistent with this section; or (5) subject to subsection (c)(3) of this section, restrict benefits for any portion of a period within a hospital length of stay required under subsection (a) of this section in a manner
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which is less favorable than the benefits provided for any preceding portion of such stay. (c) Rules of construction (1) Nothing in this section shall be construed to require a mother who is a participant or beneficiary − (A) to give birth in a hospital; or (B) to stay in the hospital for a fixed period of time following the birth of her child. (2) This section shall not apply with respect to any group health plan, or any group health insurance coverage offered by a health insurance issuer, which does not provide benefits for hospital lengths of stay in connection with childbirth for a mother or her newborn child. (3) Nothing in this section shall be construed as preventing a group health plan or issuer from imposing deductibles, coinsurance, or other cost−sharing in relation to benefits for hospital lengths of stay in connection with childbirth for a mother or newborn child under the plan (or under health insurance coverage offered in connection with a group health plan), except that such coinsurance or other cost−sharing for any portion of a period within a hospital length of stay required under subsection (a) of this section may not be greater than such coinsurance or cost−sharing for any preceding portion of such stay. (d) Notice A group health plan under this part shall comply with the notice requirement under section 1185(d) of title 29 with respect to the
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requirements of this section as if such section applied to such plan. (e) Level and type of reimbursements Nothing in this section shall be construed to prevent a group health plan or a health insurance issuer offering group health insurance coverage from negotiating the level and type of reimbursement with a provider for care provided in accordance with this section. (f) Preemption; exception for health insurance coverage in certain States (1) In general The requirements of this section shall not apply with respect to health insurance coverage if there is a State law (as defined in section 300gg−23(d)(1) of this title) for a State that regulates such coverage that is described in any of the following subparagraphs: (A) Such State law requires such coverage to provide for at least a 48−hour hospital length of stay following a normal vaginal delivery and at least a 96−hour hospital length of stay following a cesarean section. (B) Such State law requires such coverage to provide for maternity and pediatric care in accordance with guidelines established by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, or other established professional medical associations. (C) Such State law requires, in connection with such coverage
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for maternity care, that the hospital length of stay for such care is left to the decision of (or required to be made by) the attending provider in consultation with the mother. (2) Construction Section 300gg−23(a)(1) of this title shall not be construed as superseding a State law described in paragraph (1). −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2704, as added Pub. L. 104−204, title VI, Sec. 604(a)(3), Sept. 26, 1996, 110 Stat. 2939.) −MISC1− PRIOR PROVISIONS A prior section 2704 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238c of this title. EFFECTIVE DATE Section 604(c) of Pub. L. 104−204 provided that: "The amendments made by this section [enacting this section and amending sections 300gg−21 and 300gg−23 of this title] shall apply with respect to group health plans for plan years beginning on or after January 1, 1998." CONGRESSIONAL FINDINGS Section 602 of title VI of Pub. L. 104−204 provided that: "Congress finds that − "(1) the length of post−delivery hospital stay should be based on the unique characteristics of each mother and her newborn child, taking into consideration the health of the mother, the
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health and stability of the newborn, the ability and confidence of the mother and the father to care for their newborn, the adequacy of support systems at home, and the access of the mother and her newborn to appropriate follow−up health care; and "(2) the timing of the discharge of a mother and her newborn child from the hospital should be made by the attending provider in consultation with the mother." REPORTS TO CONGRESS CONCERNING CHILDBIRTH Section 606 of title VI of Pub. L. 104−204 provided that: "(a) Findings. − Congress finds that − "(1) childbirth is one part of a continuum of experience that includes prepregnancy, pregnancy and prenatal care, labor and delivery, the immediate postpartum period, and a longer period of adjustment for the newborn, the mother, and the family; "(2) health care practices across this continuum are changing in response to health care financing and delivery system changes, science and clinical research, and patient preferences; and "(3) there is a need − "(A) to examine the issues and consequences associated with the length of hospital stays following childbirth; "(B) to examine the follow−up practices for mothers and newborns used in conjunction with shorter hospital stays; "(C) to identify appropriate health care practices and procedures with regard to the hospital discharge of newborns and mothers; "(D) to examine the extent to which such care is affected by
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family and environmental factors; and "(E) to examine the content of care during hospital stays following childbirth. "(b) Advisory Panel. − "(1) In general. − Not later than 90 days after the date of enactment of this Act [Sept. 26, 1996], the Secretary of Health and Human Services (in this section referred to as the 'Secretary') shall establish an advisory panel (referred to in this section as the 'advisory panel') − "(A) to guide and review methods, procedures, and data collection necessary to conduct the study described in subsection (c) in a manner that is intended to enhance the quality, safety, and effectiveness of health care services provided to mothers and newborns; "(B) to develop a consensus among the members of the advisory panel regarding the appropriateness of the specific requirements of this title [see section 601 of Pub. L. 104−204, set out as a Short Title of 1996 Amendment note under section 201 of this title]; and "(C) to prepare and submit to the Secretary, as part of the report of the Secretary submitted under subsection (d), a report summarizing the consensus (if any) developed under subparagraph (B) or the reasons for not reaching such a consensus. "(2) Participation. − "(A) Department representatives. − The Secretary shall ensure
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that representatives from within the Department of Health and Human Services that have expertise in the area of maternal and child health or in outcomes research are appointed to the advisory panel. "(B) Representatives of public and private sector entities. − "(i) In general. − The Secretary shall ensure that members of the advisory panel include representatives of public and private sector entities having knowledge or experience in one or more of the following areas: "(I) Patient care. "(II) Patient education. "(III) Quality assurance. "(IV) Outcomes research. "(V) Consumer issues. "(ii) Requirement. − The panel shall include representatives of each of the following categories: "(I) Health care practitioners. "(II) Health plans. "(III) Hospitals. "(IV) Employers. "(V) States. "(VI) Consumers. "(c) Studies. − "(1) In general. − The Secretary shall conduct a study of − "(A) the factors affecting the continuum of care with respect to maternal and child health care, including outcomes following
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childbirth; "(B) the factors determining the length of hospital stay following childbirth; "(C) the diversity of negative or positive outcomes affecting mothers, infants, and families; "(D) the manner in which post natal care has changed over time and the manner in which that care has adapted or related to changes in the length of hospital stay, taking into account − "(i) the types of post natal care available and the extent to which such care is accessed; and "(ii) the challenges associated with providing post natal care to all populations, including vulnerable populations, and solutions for overcoming these challenges; and "(E) the financial incentives that may − "(i) impact the health of newborns and mothers; and "(ii) influence the clinical decisionmaking of health care providers. "(2) Resources. − The Secretary shall provide to the advisory panel the resources necessary to carry out the duties of the advisory panel. "(d) Reports. − "(1) In general. − The Secretary shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce [now Committee on Energy and Commerce] of the House of Representatives a report that contains −
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"(A) a summary of the study conducted under subsection (c); "(B) a summary of the best practices used in the public and private sectors for the care of newborns and mothers; "(C) recommendations for improvements in prenatal care, post natal care, delivery and follow−up care, and whether the implementation of such improvements should be accomplished by the private health care sector, Federal or State governments, or any combination thereof; and "(D) limitations on the databases in existence on the date of the enactment of this Act [Sept. 26, 1996]. "(2) Deadlines. − The Secretary shall prepare and submit to the Committees referred to in paragraph (1) − "(A) an initial report concerning the study conducted under subsection (c) and elements described in paragraph (1), not later than 18 months after the date of the enactment of this Act; "(B) an interim report concerning such study and elements not later than 3 years after the date of the enactment of this Act; and "(C) a final report concerning such study and elements not later than 5 years after the date of the enactment of this Act. "(e) Termination of Panel. − The advisory panel shall terminate on the date that occurs 60 days after the date on which the last report is submitted under subsection (d)." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS
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This section is referred to in sections 300gg−23, 300gg−51 of this title. −End− −CITE− 42 USC Sec. 300gg−5 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 2 − other requirements −HEAD− Sec. 300gg−5. Parity in application of certain limits to mental health benefits −STATUTE− (a) In general (1) Aggregate lifetime limits In the case of a group health plan (or health insurance coverage offered in connection with such a plan) that provides both medical and surgical benefits and mental health benefits − (A) No lifetime limit If the plan or coverage does not include an aggregate lifetime limit on substantially all medical and surgical benefits, the plan or coverage may not impose any aggregate lifetime limit on mental health benefits. (B) Lifetime limit
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If the plan or coverage includes an aggregate lifetime limit on substantially all medical and surgical benefits (in this paragraph referred to as the "applicable lifetime limit"), the plan or coverage shall either − (i) apply the applicable lifetime limit both to the medical and surgical benefits to which it otherwise would apply and to mental health benefits and not distinguish in the application of such limit between such medical and surgical benefits and mental health benefits; or (ii) not include any aggregate lifetime limit on mental health benefits that is less than the applicable lifetime limit. (C) Rule in case of different limits In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different aggregate lifetime limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health benefits by substituting for the applicable lifetime limit an average aggregate lifetime limit that is computed taking into account the weighted average of the aggregate lifetime limits applicable to such categories. (2) Annual limits In the case of a group health plan (or health insurance coverage offered in connection with such a plan) that provides both medical and surgical benefits and mental health benefits −
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(A) No annual limit If the plan or coverage does not include an annual limit on substantially all medical and surgical benefits, the plan or coverage may not impose any annual limit on mental health benefits. (B) Annual limit If the plan or coverage includes an annual limit on substantially all medical and surgical benefits (in this paragraph referred to as the "applicable annual limit"), the plan or coverage shall either − (i) apply the applicable annual limit both to medical and surgical benefits to which it otherwise would apply and to mental health benefits and not distinguish in the application of such limit between such medical and surgical benefits and mental health benefits; or (ii) not include any annual limit on mental health benefits that is less than the applicable annual limit. (C) Rule in case of different limits In the case of a plan or coverage that is not described in subparagraph (A) or (B) and that includes no or different annual limits on different categories of medical and surgical benefits, the Secretary shall establish rules under which subparagraph (B) is applied to such plan or coverage with respect to mental health benefits by substituting for the applicable annual limit an average annual limit that is computed taking into account the weighted average of the annual
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limits applicable to such categories. (b) Construction Nothing in this section shall be construed − (1) as requiring a group health plan (or health insurance coverage offered in connection with such a plan) to provide any mental health benefits; or (2) in the case of a group health plan (or health insurance coverage offered in connection with such a plan) that provides mental health benefits, as affecting the terms and conditions (including cost sharing, limits on numbers of visits or days of coverage, and requirements relating to medical necessity) relating to the amount, duration, or scope of mental health benefits under the plan or coverage, except as specifically provided in subsection (a) of this section (in regard to parity in the imposition of aggregate lifetime limits and annual limits for mental health benefits). (c) Exemptions (1) Small employer exemption This section shall not apply to any group health plan (and group health insurance coverage offered in connection with a group health plan) for any plan year of a small employer. (2) Increased cost exemption This section shall not apply with respect to a group health plan (or health insurance coverage offered in connection with a group health plan) if the application of this section to such plan (or to such coverage) results in an increase in the cost
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under the plan (or for such coverage) of at least 1 percent. (d) Separate application to each option offered In the case of a group health plan that offers a participant or beneficiary two or more benefit package options under the plan, the requirements of this section shall be applied separately with respect to each such option. (e) Definitions For purposes of this section − (1) Aggregate lifetime limit The term "aggregate lifetime limit" means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount that may be paid with respect to such benefits under the plan or health insurance coverage with respect to an individual or other coverage unit. (2) Annual limit The term "annual limit" means, with respect to benefits under a group health plan or health insurance coverage, a dollar limitation on the total amount of benefits that may be paid with respect to such benefits in a 12−month period under the plan or health insurance coverage with respect to an individual or other coverage unit. (3) Medical or surgical benefits The term "medical or surgical benefits" means benefits with respect to medical or surgical services, as defined under the terms of the plan or coverage (as the case may be), but does not include mental health benefits.
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(4) Mental health benefits The term "mental health benefits" means benefits with respect to mental health services, as defined under the terms of the plan or coverage (as the case may be), but does not include benefits with respect to treatment of substance abuse or chemical dependency. (f) Sunset This section shall not apply to benefits for services furnished on or after December 31, 2003. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2705, as added Pub. L. 104−204, title VII, Sec. 703(a), Sept. 26, 1996, 110 Stat. 2947; amended Pub. L. 107−116, title VII, Sec. 701(b), Jan. 10, 2002, 115 Stat. 2228; Pub. L. 107−313, Sec. 2(b), Dec. 2, 2002, 116 Stat. 2457.) −MISC1− PRIOR PROVISIONS A prior section 2705 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238d of this title. AMENDMENTS 2002 − Subsec. (f). Pub. L. 107−313 substituted "December 31, 2003" for "December 31, 2002". Pub. L. 107−116 substituted "December 31, 2002" for "September 30, 2001". EFFECTIVE DATE
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Section 703(b) of Pub. L. 104−204 provided that: "The amendments made by this section [enacting this section] shall apply with respect to group health plans for plan years beginning on or after January 1, 1998." −End− −CITE− 42 USC Sec. 300gg−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 2 − other requirements −HEAD− Sec. 300gg−6. Required coverage for reconstructive surgery following mastectomies −STATUTE− The provisions of section 1185b of title 29 shall apply to group health plans, and health insurance issuers providing health insurance coverage in connection with group health plans, as if included in this subpart. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2706, as added Pub. L. 105−277, div. A, Sec. 101(f) [title IX, Sec. 903(a)], Oct. 21, 1998, 112 Stat. 2681−337, 2681−438.) −MISC1−
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EFFECTIVE DATE Pub. L. 105−277, div. A, Sec. 101(f) [title IX, Sec. 903(c)(1)], Oct. 21, 1998, 112 Stat. 2681−337, 2681−438, provided that: "(A) In general. − The amendment made by subsection (a) [enacting this section] shall apply to group health plans for plan years beginning on or after the date of enactment of this Act [Oct. 21, 1998]. "(B) Special rule for collective bargaining agreements. − In the case of a group health plan maintained pursuant to 1 or more collective bargaining agreements between employee representatives and 1 or more employers, any plan amendment made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by the amendment made by subsection (a) shall not be treated as a termination of such collective bargaining agreement." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300gg−52 of this title. −End− −CITE− 42 USC subpart 3 − provisions applicable only to health insurance issuers 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
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Part A − Group Market Reforms subpart 3 − provisions applicable only to health insurance issuers −HEAD− SUBPART 3 − PROVISIONS APPLICABLE ONLY TO HEALTH INSURANCE ISSUERS −MISC1− AMENDMENTS 1996 − Pub. L. 104−204, title VI, Sec. 604(a)(2), Sept. 26, 1996, 110 Stat. 2939, redesignated subpart 2 as 3. −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in section 300gg−21 of this title. −End− −CITE− 42 USC Sec. 300gg−11 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 3 − provisions applicable only to health insurance issuers −HEAD− Sec. 300gg−11. Guaranteed availability of coverage for employers in group market −STATUTE− (a) Issuance of coverage in small group market (1) In general
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Subject to subsections (c) through (f) of this section, each health insurance issuer that offers health insurance coverage in the small group market in a State − (A) must accept every small employer (as defined in section 300gg−91(e)(4) of this title) in the State that applies for such coverage; and (B) must accept for enrollment under such coverage every eligible individual (as defined in paragraph (2)) who applies for enrollment during the period in which the individual first becomes eligible to enroll under the terms of the group health plan and may not place any restriction which is inconsistent with section 300gg−1 of this title on an eligible individual being a participant or beneficiary. (2) "Eligible individual" defined For purposes of this section, the term "eligible individual" means, with respect to a health insurance issuer that offers health insurance coverage to a small employer in connection with a group health plan in the small group market, such an individual in relation to the employer as shall be determined − (A) in accordance with the terms of such plan, (B) as provided by the issuer under rules of the issuer which are uniformly applicable in a State to small employers in the small group market, and (C) in accordance with all applicable State laws governing such issuer and such market. (b) Assuring access in large group market
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(1) Reports to HHS The Secretary shall request that the chief executive officer of each State submit to the Secretary, by not later December 31, 2000, and every 3 years thereafter a report on − (A) the access of large employers to health insurance coverage in the State, and (B) the circumstances for lack of access (if any) of large employers (or one or more classes of such employers) in the State to such coverage. (2) Triennial reports to Congress The Secretary, based on the reports submitted under paragraph (1) and such other information as the Secretary may use, shall prepare and submit to Congress, every 3 years, a report describing the extent to which large employers (and classes of such employers) that seek health insurance coverage in the different States are able to obtain access to such coverage. Such report shall include such recommendations as the Secretary determines to be appropriate. (3) GAO report on large employer access to health insurance coverage The Comptroller General shall provide for a study of the extent to which classes of large employers in the different States are able to obtain access to health insurance coverage and the circumstances for lack of access (if any) to such coverage. The Comptroller General shall submit to Congress a report on such study not later than 18 months after August 21, 1996.
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(c) Special rules for network plans (1) In general In the case of a health insurance issuer that offers health insurance coverage in the small group market through a network plan, the issuer may − (A) limit the employers that may apply for such coverage to those with eligible individuals who live, work, or reside in the service area for such network plan; and (B) within the service area of such plan, deny such coverage to such employers if the issuer has demonstrated, if required, to the applicable State authority that − (i) it will not have the capacity to deliver services adequately to enrollees of any additional groups because of its obligations to existing group contract holders and enrollees, and (ii) it is applying this paragraph uniformly to all employers without regard to the claims experience of those employers and their employees (and their dependents) or any health status−related factor relating to such employees and dependents. (2) 180−day suspension upon denial of coverage An issuer, upon denying health insurance coverage in any service area in accordance with paragraph (1)(B), may not offer coverage in the small group market within such service area for a period of 180 days after the date such coverage is denied. (d) Application of financial capacity limits
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(1) In general A health insurance issuer may deny health insurance coverage in the small group market if the issuer has demonstrated, if required, to the applicable State authority that − (A) it does not have the financial reserves necessary to underwrite additional coverage; and (B) it is applying this paragraph uniformly to all employers in the small group market in the State consistent with applicable State law and without regard to the claims experience of those employers and their employees (and their dependents) or any health status−related factor relating to such employees and dependents. (2) 180−day suspension upon denial of coverage A health insurance issuer upon denying health insurance coverage in connection with group health plans in accordance with paragraph (1) in a State may not offer coverage in connection with group health plans in the small group market in the State for a period of 180 days after the date such coverage is denied or until the issuer has demonstrated to the applicable State authority, if required under applicable State law, that the issuer has sufficient financial reserves to underwrite additional coverage, whichever is later. An applicable State authority may provide for the application of this subsection on a service−area−specific basis. (e) Exception to requirement for failure to meet certain minimum participation or contribution rules
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(1) In general Subsection (a) of this section shall not be construed to preclude a health insurance issuer from establishing employer contribution rules or group participation rules for the offering of health insurance coverage in connection with a group health plan in the small group market, as allowed under applicable State law. (2) Rules defined For purposes of paragraph (1) − (A) the term "employer contribution rule" means a requirement relating to the minimum level or amount of employer contribution toward the premium for enrollment of participants and beneficiaries; and (B) the term "group participation rule" means a requirement relating to the minimum number of participants or beneficiaries that must be enrolled in relation to a specified percentage or number of eligible individuals or employees of an employer. (f) Exception for coverage offered only to bona fide association members Subsection (a) of this section shall not apply to health insurance coverage offered by a health insurance issuer if such coverage is made available in the small group market only through one or more bona fide associations (as defined in section 300gg−91(d)(3) of this title). −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2711, as added Pub. L.
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104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1962.) −MISC1− PRIOR PROVISIONS A prior section 2711 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238j of this title. EFFECTIVE DATE Section applicable with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997, except as otherwise provided, see section 102(c) of Pub. L. 104−191, set out as a note under section 300gg of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300gg−12 of this title. −End− −CITE− 42 USC Sec. 300gg−12 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 3 − provisions applicable only to health insurance issuers −HEAD− Sec. 300gg−12. Guaranteed renewability of coverage for employers in
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group market −STATUTE− (a) In general Except as provided in this section, if a health insurance issuer offers health insurance coverage in the small or large group market in connection with a group health plan, the issuer must renew or continue in force such coverage at the option of the plan sponsor of the plan. (b) General exceptions A health insurance issuer may nonrenew or discontinue health insurance coverage offered in connection with a group health plan in the small or large group market based only on one or more of the following: (1) Nonpayment of premiums The plan sponsor has failed to pay premiums or contributions in accordance with the terms of the health insurance coverage or the issuer has not received timely premium payments. (2) Fraud The plan sponsor has performed an act or practice that constitutes fraud or made an intentional misrepresentation of material fact under the terms of the coverage. (3) Violation of participation or contribution rules The plan sponsor has failed to comply with a material plan provision relating to employer contribution or group participation rules, as permitted under section 300gg−11(e) of this title in the case of the small group market or pursuant to
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applicable State law in the case of the large group market. (4) Termination of coverage The issuer is ceasing to offer coverage in such market in accordance with subsection (c) of this section and applicable State law. (5) Movement outside service area In the case of a health insurance issuer that offers health insurance coverage in the market through a network plan, there is no longer any enrollee in connection with such plan who lives, resides, or works in the service area of the issuer (or in the area for which the issuer is authorized to do business) and, in the case of the small group market, the issuer would deny enrollment with respect to such plan under section 300gg−11(c)(1)(A) of this title. (6) Association membership ceases In the case of health insurance coverage that is made available in the small or large group market (as the case may be) only through one or more bona fide associations, the membership of an employer in the association (on the basis of which the coverage is provided) ceases but only if such coverage is terminated under this paragraph uniformly without regard to any health status−related factor relating to any covered individual. (c) Requirements for uniform termination of coverage (1) Particular type of coverage not offered In any case in which an issuer decides to discontinue offering a particular type of group health insurance coverage offered in
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the small or large group market, coverage of such type may be discontinued by the issuer in accordance with applicable State law in such market only if − (A) the issuer provides notice to each plan sponsor provided coverage of this type in such market (and participants and beneficiaries covered under such coverage) of such discontinuation at least 90 days prior to the date of the discontinuation of such coverage; (B) the issuer offers to each plan sponsor provided coverage of this type in such market, the option to purchase all (or, in the case of the large group market, any) other health insurance coverage currently being offered by the issuer to a group health plan in such market; and (C) in exercising the option to discontinue coverage of this type and in offering the option of coverage under subparagraph (B), the issuer acts uniformly without regard to the claims experience of those sponsors or any health status−related factor relating to any participants or beneficiaries covered or new participants or beneficiaries who may become eligible for such coverage. (2) Discontinuance of all coverage (A) In general In any case in which a health insurance issuer elects to discontinue offering all health insurance coverage in the small group market or the large group market, or both markets, in a State, health insurance coverage may be discontinued by the
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issuer only in accordance with applicable State law and if − (i) the issuer provides notice to the applicable State authority and to each plan sponsor (and participants and beneficiaries covered under such coverage) of such discontinuation at least 180 days prior to the date of the discontinuation of such coverage; and (ii) all health insurance issued or delivered for issuance in the State in such market (or markets) are discontinued and coverage under such health insurance coverage in such market (or markets) is not renewed. (B) Prohibition on market reentry In the case of a discontinuation under subparagraph (A) in a market, the issuer may not provide for the issuance of any health insurance coverage in the market and State involved during the 5−year period beginning on the date of the discontinuation of the last health insurance coverage not so renewed. (d) Exception for uniform modification of coverage At the time of coverage renewal, a health insurance issuer may modify the health insurance coverage for a product offered to a group health plan − (1) in the large group market; or (2) in the small group market if, for coverage that is available in such market other than only through one or more bona fide associations, such modification is consistent with State law and effective on a uniform basis among group health plans with
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that product. (e) Application to coverage offered only through associations In applying this section in the case of health insurance coverage that is made available by a health insurance issuer in the small or large group market to employers only through one or more associations, a reference to "plan sponsor" is deemed, with respect to coverage provided to an employer member of the association, to include a reference to such employer. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2712, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1964.) −MISC1− PRIOR PROVISIONS A prior section 2712 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238k of this title. EFFECTIVE DATE Section applicable with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997, except as otherwise provided, see section 102(c) of Pub. L. 104−191, set out as a note under section 300gg of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300gg−41 of this title. −End−
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−CITE− 42 USC Sec. 300gg−13 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 3 − provisions applicable only to health insurance issuers −HEAD− Sec. 300gg−13. Disclosure of information −STATUTE− (a) Disclosure of information by health plan issuers In connection with the offering of any health insurance coverage to a small employer, a health insurance issuer − (1) shall make a reasonable disclosure to such employer, as part of its solicitation and sales materials, of the availability of information described in subsection (b) of this section, and (2) upon request of such a small employer, provide such information. (b) Information described (1) In general Subject to paragraph (3), with respect to a health insurance issuer offering health insurance coverage to a small employer, information described in this subsection is information concerning − (A) the provisions of such coverage concerning issuer's right
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to change premium rates and the factors that may affect changes in premium rates; (B) the provisions of such coverage relating to renewability of coverage; (C) the provisions of such coverage relating to any preexisting condition exclusion; and (D) the benefits and premiums available under all health insurance coverage for which the employer is qualified. (2) Form of information Information under this subsection shall be provided to small employers in a manner determined to be understandable by the average small employer, and shall be sufficient to reasonably inform small employers of their rights and obligations under the health insurance coverage. (3) Exception An issuer is not required under this section to disclose any information that is proprietary and trade secret information under applicable law. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2713, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1966.) −MISC1− PRIOR PROVISIONS A prior section 2713 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238l of this title.
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EFFECTIVE DATE Section applicable with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997, except as otherwise provided, see section 102(c) of Pub. L. 104−191, set out as a note under section 300gg of this title. −End− −CITE− 42 USC subpart 4 − exclusion of plans; enforcement; preemption 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 4 − exclusion of plans; enforcement; preemption −HEAD− SUBPART 4 − EXCLUSION OF PLANS; ENFORCEMENT; PREEMPTION −MISC1− AMENDMENTS 1996 − Pub. L. 104−204, title VI, Sec. 604(a)(2), Sept. 26, 1996, 110 Stat. 2939, redesignated subpart 3 as 4. −End− −CITE− 42 USC Sec. 300gg−21 01/06/03 −EXPCITE−
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TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 4 − exclusion of plans; enforcement; preemption −HEAD− Sec. 300gg−21. Exclusion of certain plans −STATUTE− (a) Exception for certain small group health plans The requirements of subparts 1 and 3 shall not apply to any group health plan (and health insurance coverage offered in connection with a group health plan) for any plan year if, on the first day of such plan year, such plan has less than 2 participants who are current employees. (b) Limitation on application of provisions relating to group health plans (1) In general The requirements of subparts 1 through 3 shall apply with respect to group health plans only − (A) subject to paragraph (2), in the case of a plan that is a nonfederal (!1) governmental plan, and (B) with respect to health insurance coverage offered in connection with a group health plan (including such a plan that is a church plan or a governmental plan). (2) Treatment of non−Federal governmental plans (A) Election to be excluded
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If the plan sponsor of a nonfederal (!1) governmental plan which is a group health plan to which the provisions of subparts 1 through 3 otherwise apply makes an election under this subparagraph (in such form and manner as the Secretary may by regulations prescribe), then the requirements of such subparts insofar as they apply directly to group health plans (and not merely to group health insurance coverage) shall not apply to such governmental plans for such period except as provided in this paragraph. (B) Period of election An election under subparagraph (A) shall apply − (i) for a single specified plan year, or (ii) in the case of a plan provided pursuant to a collective bargaining agreement, for the term of such agreement. An election under clause (i) may be extended through subsequent elections under this paragraph. (C) Notice to enrollees Under such an election, the plan shall provide for − (i) notice to enrollees (on an annual basis and at the time of enrollment under the plan) of the fact and consequences of such election, and (ii) certification and disclosure of creditable coverage under the plan with respect to enrollees in accordance with section 300gg(e) of this title. (c) Exception for certain benefits
477
The requirements of subparts 1 through 3 shall not apply to any group health plan (or group health insurance coverage) in relation to its provision of excepted benefits described in section 300gg−91(c)(1) of this title. (d) Exception for certain benefits if certain conditions met (1) Limited, excepted benefits The requirements of subparts 1 through 3 shall not apply to any group health plan (and group health insurance coverage offered in connection with a group health plan) in relation to its provision of excepted benefits described in section 300gg−91(c)(2) of this title if the benefits − (A) are provided under a separate policy, certificate, or contract of insurance; or (B) are otherwise not an integral part of the plan. (2) Noncoordinated, excepted benefits The requirements of subparts 1 through 3 shall not apply to any group health plan (and group health insurance coverage offered in connection with a group health plan) in relation to its provision of excepted benefits described in section 300gg−91(c)(3) of this title if all of the following conditions are met: (A) The benefits are provided under a separate policy, certificate, or contract of insurance. (B) There is no coordination between the provision of such benefits and any exclusion of benefits under any group health plan maintained by the same plan sponsor. (C) Such benefits are paid with respect to an event without
478
regard to whether benefits are provided with respect to such an event under any group health plan maintained by the same plan sponsor. (3) Supplemental excepted benefits The requirements of this part shall not apply to any group health plan (and group health insurance coverage) in relation to its provision of excepted benefits described in section 300gg−91(c)(4) (!2) of this title if the benefits are provided under a separate policy, certificate, or contract of insurance. (e) Treatment of partnerships For purposes of this part − (1) Treatment as a group health plan Any plan, fund, or program which would not be (but for this subsection) an employee welfare benefit plan and which is established or maintained by a partnership, to the extent that such plan, fund, or program provides medical care (including items and services paid for as medical care) to present or former partners in the partnership or to their dependents (as defined under the terms of the plan, fund, or program), directly or through insurance, reimbursement, or otherwise, shall be treated (subject to paragraph (2)) as an employee welfare benefit plan which is a group health plan. (2) Employer In the case of a group health plan, the term "employer" also includes the partnership in relation to any partner. (3) Participants of group health plans
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In the case of a group health plan, the term "participant" also includes − (A) in connection with a group health plan maintained by a partnership, an individual who is a partner in relation to the partnership, or (B) in connection with a group health plan maintained by a self−employed individual (under which one or more employees are participants), the self−employed individual, if such individual is, or may become, eligible to receive a benefit under the plan or such individual's beneficiaries may be eligible to receive any such benefit. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2721, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1967; amended Pub. L. 104−204, title VI, Sec. 604(b)(1), Sept. 26, 1996, 110 Stat. 2940.) −REFTEXT− REFERENCES IN TEXT Section 300gg−91(c)(4) of this title, referred to in subsec. (d)(3), was in the original "section 27971(c)(4)" and was translated as reading "section 2791(c)(4)", meaning section 2791(c)(4) of act July 1, 1944, as added by Pub. L. 104−191, Sec. 102(a), to reflect the probable intent of Congress. Act July 1, 1944, does not contain a section 27971. −MISC1− AMENDMENTS
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1996 − Subsec. (a). Pub. L. 104−204, Sec. 604(b)(1)(A), substituted "subparts 1 and 3" for "subparts 1 and 2". Subsec. (b) to (d). Pub. L. 104−204, Sec. 604(b)(1)(B), substituted "subparts 1 through 3" for "subparts 1 and 2" wherever appearing. EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−204 applicable with respect to group health plans for plan years beginning on or after Jan. 1, 1998, see section 604(c) of Pub. L. 104−204 set out as an Effective Date note under section 300gg−4 of this title. EFFECTIVE DATE Section applicable with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997, except as otherwise provided, see section 102(c) of Pub. L. 104−191, set out as a note under section 300gg of this title. −FOOTNOTE− (!1) So in original. Probably should be "non−Federal". (!2) See References in Text note below. −End− −CITE− 42 USC Sec. 300gg−22 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE
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Part A − Group Market Reforms subpart 4 − exclusion of plans; enforcement; preemption −HEAD− Sec. 300gg−22. Enforcement −STATUTE− (a) State enforcement (1) State authority Subject to section 300gg−23 of this title, each State may require that health insurance issuers that issue, sell, renew, or offer health insurance coverage in the State in the small or large group markets meet the requirements of this part with respect to such issuers. (2) Failure to implement provisions In the case of a determination by the Secretary that a State has failed to substantially enforce a provision (or provisions) in this part with respect to health insurance issuers in the State, the Secretary shall enforce such provision (or provisions) under subsection (b) of this section insofar as they relate to the issuance, sale, renewal, and offering of health insurance coverage in connection with group health plans in such State. (b) Secretarial enforcement authority (1) Limitation The provisions of this subsection shall apply to enforcement of a provision (or provisions) of this part only − (A) as provided under subsection (a)(2) of this section; and (B) with respect to group health plans that are non−Federal
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governmental plans. (2) Imposition of penalties In the cases described in paragraph (1) − (A) In general Subject to the succeeding provisions of this subsection, any non−Federal governmental plan that is a group health plan and any health insurance issuer that fails to meet a provision of this part applicable to such plan or issuer is subject to a civil money penalty under this subsection. (B) Liability for penalty In the case of a failure by − (i) a health insurance issuer, the issuer is liable for such penalty, or (ii) a group health plan that is a non−Federal governmental plan which is − (I) sponsored by 2 or more employers, the plan is liable for such penalty, or (II) not so sponsored, the employer is liable for such penalty. (C) Amount of penalty (i) In general The maximum amount of penalty imposed under this paragraph is $100 for each day for each individual with respect to which such a failure occurs. (ii) Considerations in imposition In determining the amount of any penalty to be assessed
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under this paragraph, the Secretary shall take into account the previous record of compliance of the entity being assessed with the applicable provisions of this part and the gravity of the violation. (iii) Limitations (I) Penalty not to apply where failure not discovered exercising reasonable diligence No civil money penalty shall be imposed under this paragraph on any failure during any period for which it is established to the satisfaction of the Secretary that none of the entities against whom the penalty would be imposed knew, or exercising reasonable diligence would have known, that such failure existed. (II) Penalty not to apply to failures corrected within 30 days No civil money penalty shall be imposed under this paragraph on any failure if such failure was due to reasonable cause and not to willful neglect, and such failure is corrected during the 30−day period beginning on the first day any of the entities against whom the penalty would be imposed knew, or exercising reasonable diligence would have known, that such failure existed. (D) Administrative review (i) Opportunity for hearing The entity assessed shall be afforded an opportunity for hearing by the Secretary upon request made within 30 days
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after the date of the issuance of a notice of assessment. In such hearing the decision shall be made on the record pursuant to section 554 of title 5. If no hearing is requested, the assessment shall constitute a final and unappealable order. (ii) Hearing procedure If a hearing is requested, the initial agency decision shall be made by an administrative law judge, and such decision shall become the final order unless the Secretary modifies or vacates the decision. Notice of intent to modify or vacate the decision of the administrative law judge shall be issued to the parties within 30 days after the date of the decision of the judge. A final order which takes effect under this paragraph shall be subject to review only as provided under subparagraph (E). (E) Judicial review (i) Filing of action for review Any entity against whom an order imposing a civil money penalty has been entered after an agency hearing under this paragraph may obtain review by the United States district court for any district in which such entity is located or the United States District Court for the District of Columbia by filing a notice of appeal in such court within 30 days from the date of such order, and simultaneously sending a copy of such notice by registered mail to the Secretary. (ii) Certification of administrative record
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The Secretary shall promptly certify and file in such court the record upon which the penalty was imposed. (iii) Standard for review The findings of the Secretary shall be set aside only if found to be unsupported by substantial evidence as provided by section 706(2)(E) of title 5. (iv) Appeal Any final decision, order, or judgment of the district court concerning such review shall be subject to appeal as provided in chapter 83 of title 28. (F) Failure to pay assessment; maintenance of action (i) Failure to pay assessment If any entity fails to pay an assessment after it has become a final and unappealable order, or after the court has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General who shall recover the amount assessed by action in the appropriate United States district court. (ii) Nonreviewability In such action the validity and appropriateness of the final order imposing the penalty shall not be subject to review. (G) Payment of penalties Except as otherwise provided, penalties collected under this paragraph shall be paid to the Secretary (or other officer) imposing the penalty and shall be available without
486
appropriation and until expended for the purpose of enforcing the provisions with respect to which the penalty was imposed. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2722, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1968.) −MISC1− EFFECTIVE DATE Section applicable with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997, except as otherwise provided, see section 102(c) of Pub. L. 104−191, set out as a note under section 300gg of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300gg−61 of this title. −End− −CITE− 42 USC Sec. 300gg−23 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part A − Group Market Reforms subpart 4 − exclusion of plans; enforcement; preemption −HEAD− Sec. 300gg−23. Preemption; State flexibility; construction
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−STATUTE− (a) Continued applicability of State law with respect to health insurance issuers (1) In general Subject to paragraph (2) and except as provided in subsection (b) of this section, this part and part C of this subchapter insofar as it relates to this part shall not be construed to supersede any provision of State law which establishes, implements, or continues in effect any standard or requirement solely relating to health insurance issuers in connection with group health insurance coverage except to the extent that such standard or requirement prevents the application of a requirement of this part. (2) Continued preemption with respect to group health plans Nothing in this part shall be construed to affect or modify the provisions of section 1144 of title 29 with respect to group health plans. (b) Special rules in case of portability requirements (1) In general Subject to paragraph (2), the provisions of this part relating to health insurance coverage offered by a health insurance issuer supersede any provision of State law which establishes, implements, or continues in effect a standard or requirement applicable to imposition of a preexisting condition exclusion specifically governed by section 300gg of this title (!1) which differs from the standards or requirements specified in such
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section. (2) Exceptions Only in relation to health insurance coverage offered by a health insurance issuer, the provisions of this part do not supersede any provision of State law to the extent that such provision − (i) substitutes for the reference to "6−month period" in section 300gg(a)(1) of this title a reference to any shorter period of time; (ii) substitutes for the reference to "12 months" and "18 months" in section 300gg(a)(2) of this title a reference to any shorter period of time; (iii) substitutes for the references to "63" days in sections 300gg(c)(2)(A) and 300gg(d)(4)(A) (!2) of this title a reference to any greater number of days; (iv) substitutes for the reference to "30−day period" in sections 300gg(b)(2) and 300gg(d)(1) of this title a reference to any greater period; (v) prohibits the imposition of any preexisting condition exclusion in cases not described in section 300gg(d) of this title or expands the exceptions described in such section; (vi) requires special enrollment periods in addition to those required under section 300gg(f) of this title; or (vii) reduces the maximum period permitted in an affiliation period under section 300gg(g)(1)(B) of this title. (c) Rules of construction
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Nothing in this part (other than section 300gg−4 of this title) shall be construed as requiring a group health plan or health insurance coverage to provide specific benefits under the terms of such plan or coverage. (d) Definitions For purposes of this section − (1) State law The term "State law" includes all laws, decisions, rules, regulations, or other State action having the effect of law, of any State. A law of the United States applicable only to the District of Columbia shall be treated as a State law rather than a law of the United States. (2) State The term "State" includes a State (including the Northern Mariana Islands), any political subdivisions of a State or such Islands, or any agency or instrumentality of either. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2723, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1971; amended Pub. L. 104−204, title VI, Sec. 604(b)(2), Sept. 26, 1996, 110 Stat. 2941.) −REFTEXT− REFERENCES IN TEXT Section 300gg of this title, referred to in subsec. (b)(1), was in the original "section 701" and was translated as reading "section 2701" meaning section 2701 of act July 1, 1944, as added
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by Pub. L. 104−191, Sec. 102(a), to reflect the probable intent of Congress. −MISC1− AMENDMENTS 1996 − Subsec. (c). Pub. L. 104−204 inserted "(other than section 300gg−4 of this title)" after "part". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−204 applicable with respect to group health plans for plan years beginning on or after Jan. 1, 1998, see section 604(c) of Pub. L. 104−204 set out as an Effective Date note under section 300gg−4 of this title. EFFECTIVE DATE Section applicable with respect to group health plans, and health insurance coverage offered in connection with group health plans, for plan years beginning after June 30, 1997, except as otherwise provided, see section 102(c) of Pub. L. 104−191, set out as a note under section 300gg of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300gg−4, 300gg−22, 300gg−51 of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) So in original. Probably should be "300gg(d)(4)". −End− −CITE−
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42 USC Part B − Individual Market Rules 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules −HEAD− PART B − INDIVIDUAL MARKET RULES −End− −CITE− 42 USC subpart 1 − portability, access, and renewability requirements 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 1 − portability, access, and renewability requirements −HEAD− SUBPART 1 − PORTABILITY, ACCESS, AND RENEWABILITY REQUIREMENTS −End− −CITE− 42 USC Sec. 300gg−41 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE
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SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 1 − portability, access, and renewability requirements −HEAD− Sec. 300gg−41. Guaranteed availability of individual health insurance coverage to certain individuals with prior group coverage −STATUTE− (a) Guaranteed availability (1) In general Subject to the succeeding subsections of this section and section 300gg−44 of this title, each health insurance issuer that offers health insurance coverage (as defined in section 300gg−91(b)(1) of this title) in the individual market in a State may not, with respect to an eligible individual (as defined in subsection (b) of this section) desiring to enroll in individual health insurance coverage − (A) decline to offer such coverage to, or deny enrollment of, such individual; or (B) impose any preexisting condition exclusion (as defined in section 300gg(b)(1)(A) of this title) with respect to such coverage. (2) Substitution by State of acceptable alternative mechanism The requirement of paragraph (1) shall not apply to health insurance coverage offered in the individual market in a State in which the State is implementing an acceptable alternative
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mechanism under section 300gg−44 of this title. (b) "Eligible individual" defined In this part, the term "eligible individual" means an individual − (1)(A) for whom, as of the date on which the individual seeks coverage under this section, the aggregate of the periods of creditable coverage (as defined in section 300gg(c) of this title) is 18 or more months and (B) whose most recent prior creditable coverage was under a group health plan, governmental plan, or church plan (or health insurance coverage offered in connection with any such plan); (2) who is not eligible for coverage under (A) a group health plan, (B) part A or part B of title XVIII of the Social Security Act [42 U.S.C. 1395c et seq., 1395j et seq.], or (C) a State plan under title XIX of such Act [42 U.S.C. 1396 et seq.] (or any successor program), and does not have other health insurance coverage; (3) with respect to whom the most recent coverage within the coverage period described in paragraph (1)(A) was not terminated based on a factor described in paragraph (1) or (2) of section 300gg−12(b) of this title (relating to nonpayment of premiums or fraud); (4) if the individual had been offered the option of continuation coverage under a COBRA continuation provision or under a similar State program, who elected such coverage; and (5) who, if the individual elected such continuation coverage,
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has exhausted such continuation coverage under such provision or program. (c) Alternative coverage permitted where no State mechanism (1) In general In the case of health insurance coverage offered in the individual market in a State in which the State is not implementing an acceptable alternative mechanism under section 300gg−44 of this title, the health insurance issuer may elect to limit the coverage offered under subsection (a) of this section so long as it offers at least two different policy forms of health insurance coverage both of which − (A) are designed for, made generally available to, and actively marketed to, and enroll both eligible and other individuals by the issuer; and (B) meet the requirement of paragraph (2) or (3), as elected by the issuer. For purposes of this subsection, policy forms which have different cost−sharing arrangements or different riders shall be considered to be different policy forms. (2) Choice of most popular policy forms The requirement of this paragraph is met, for health insurance coverage policy forms offered by an issuer in the individual market, if the issuer offers the policy forms for individual health insurance coverage with the largest, and next to largest, premium volume of all such policy forms offered by the issuer in the State or applicable marketing or service area (as may be
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prescribed in regulation) by the issuer in the individual market in the period involved. (3) Choice of 2 policy forms with representative coverage (A) In general The requirement of this paragraph is met, for health insurance coverage policy forms offered by an issuer in the individual market, if the issuer offers a lower−level coverage policy form (as defined in subparagraph (B)) and a higher−level coverage policy form (as defined in subparagraph (C)) each of which includes benefits substantially similar to other individual health insurance coverage offered by the issuer in that State and each of which is covered under a method described in section 300gg−44(c)(3)(A) of this title (relating to risk adjustment, risk spreading, or financial subsidization). (B) Lower−level of coverage described A policy form is described in this subparagraph if the actuarial value of the benefits under the coverage is at least 85 percent but not greater than 100 percent of a weighted average (described in subparagraph (D)). (C) Higher−level of coverage described A policy form is described in this subparagraph if − (i) the actuarial value of the benefits under the coverage is at least 15 percent greater than the actuarial value of the coverage described in subparagraph (B) offered by the issuer in the area involved; and
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(ii) the actuarial value of the benefits under the coverage is at least 100 percent but not greater than 120 percent of a weighted average (described in subparagraph (D)). (D) Weighted average For purposes of this paragraph, the weighted average described in this subparagraph is the average actuarial value of the benefits provided by all the health insurance coverage issued (as elected by the issuer) either by that issuer or by all issuers in the State in the individual market during the previous year (not including coverage issued under this section), weighted by enrollment for the different coverage. (4) Election The issuer elections under this subsection shall apply uniformly to all eligible individuals in the State for that issuer. Such an election shall be effective for policies offered during a period of not shorter than 2 years. (5) Assumptions For purposes of paragraph (3), the actuarial value of benefits provided under individual health insurance coverage shall be calculated based on a standardized population and a set of standardized utilization and cost factors. (d) Special rules for network plans (1) In general In the case of a health insurance issuer that offers health insurance coverage in the individual market through a network plan, the issuer may −
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(A) limit the individuals who may be enrolled under such coverage to those who live, reside, or work within the service area for such network plan; and (B) within the service area of such plan, deny such coverage to such individuals if the issuer has demonstrated, if required, to the applicable State authority that − (i) it will not have the capacity to deliver services adequately to additional individual enrollees because of its obligations to existing group contract holders and enrollees and individual enrollees, and (ii) it is applying this paragraph uniformly to individuals without regard to any health status−related factor of such individuals and without regard to whether the individuals are eligible individuals. (2) 180−day suspension upon denial of coverage An issuer, upon denying health insurance coverage in any service area in accordance with paragraph (1)(B), may not offer coverage in the individual market within such service area for a period of 180 days after such coverage is denied. (e) (!1) Application of financial capacity limits (1) In general A health insurance issuer may deny health insurance coverage in the individual market to an eligible individual if the issuer has demonstrated, if required, to the applicable State authority that − (A) it does not have the financial reserves necessary to
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underwrite additional coverage; and (B) it is applying this paragraph uniformly to all individuals in the individual market in the State consistent with applicable State law and without regard to any health status−related factor of such individuals and without regard to whether the individuals are eligible individuals. (2) 180−day suspension upon denial of coverage An issuer upon denying individual health insurance coverage in any service area in accordance with paragraph (1) may not offer such coverage in the individual market within such service area for a period of 180 days after the date such coverage is denied or until the issuer has demonstrated, if required under applicable State law, to the applicable State authority that the issuer has sufficient financial reserves to underwrite additional coverage, whichever is later. A State may provide for the application of this paragraph on a service−area−specific basis. (e) (!1) Market requirements (1) In general The provisions of subsection (a) of this section shall not be construed to require that a health insurance issuer offering health insurance coverage only in connection with group health plans or through one or more bona fide associations, or both, offer such health insurance coverage in the individual market. (2) Conversion policies A health insurance issuer offering health insurance coverage in connection with group health plans under this subchapter shall
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not be deemed to be a health insurance issuer offering individual health insurance coverage solely because such issuer offers a conversion policy. (f) Construction Nothing in this section shall be construed − (1) to restrict the amount of the premium rates that an issuer may charge an individual for health insurance coverage provided in the individual market under applicable State law; or (2) to prevent a health insurance issuer offering health insurance coverage in the individual market from establishing premium discounts or rebates or modifying otherwise applicable copayments or deductibles in return for adherence to programs of health promotion and disease prevention. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2741, as added Pub. L. 104−191, title I, Sec. 111(a), Aug. 21, 1996, 110 Stat. 1978.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in subsec. (b)(2), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Parts A and B of title XVIII of the Act are classified generally to parts A (Sec. 1395c et seq.) and B (Sec. 1395j et seq.) of subchapter XVIII of chapter 7 of this title. Title XIX of the Act is classified generally to subchapter XIX (Sec. 1396 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.
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−MISC1− EFFECTIVE DATE Section 111(b) of Pub. L. 104−191 provided that: "(1) In general. − Except as provided in this subsection, part B of title XXVII of the Public Health Service Act [this part] (as inserted by subsection (a)) shall apply with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs. "(2) Application of certification rules. − The provisions of section 102(d)(2) [102(c)(2)] of this Act [set out as a note under section 300gg of this title] shall apply to section 2743 of the Public Health Service Act [section 300gg−43 of this title] in the same manner as it applies to section 2701(e) of such Act [section 300gg(e) of this title]." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300gg−44 of this title. −FOOTNOTE− (!1) So in original. Two subsecs. (e) have been enacted. −End− −CITE− 42 USC Sec. 300gg−42 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE
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SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 1 − portability, access, and renewability requirements −HEAD− Sec. 300gg−42. Guaranteed renewability of individual health insurance coverage −STATUTE− (a) In general Except as provided in this section, a health insurance issuer that provides individual health insurance coverage to an individual shall renew or continue in force such coverage at the option of the individual. (b) General exceptions A health insurance issuer may nonrenew or discontinue health insurance coverage of an individual in the individual market based only on one or more of the following: (1) Nonpayment of premiums The individual has failed to pay premiums or contributions in accordance with the terms of the health insurance coverage or the issuer has not received timely premium payments. (2) Fraud The individual has performed an act or practice that constitutes fraud or made an intentional misrepresentation of material fact under the terms of the coverage. (3) Termination of plan The issuer is ceasing to offer coverage in the individual
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market in accordance with subsection (c) of this section and applicable State law. (4) Movement outside service area In the case of a health insurance issuer that offers health insurance coverage in the market through a network plan, the individual no longer resides, lives, or works in the service area (or in an area for which the issuer is authorized to do business) but only if such coverage is terminated under this paragraph uniformly without regard to any health status−related factor of covered individuals. (5) Association membership ceases In the case of health insurance coverage that is made available in the individual market only through one or more bona fide associations, the membership of the individual in the association (on the basis of which the coverage is provided) ceases but only if such coverage is terminated under this paragraph uniformly without regard to any health status−related factor of covered individuals. (c) Requirements for uniform termination of coverage (1) Particular type of coverage not offered In any case in which an issuer decides to discontinue offering a particular type of health insurance coverage offered in the individual market, coverage of such type may be discontinued by the issuer only if − (A) the issuer provides notice to each covered individual provided coverage of this type in such market of such
503
discontinuation at least 90 days prior to the date of the discontinuation of such coverage; (B) the issuer offers to each individual in the individual market provided coverage of this type, the option to purchase any other individual health insurance coverage currently being offered by the issuer for individuals in such market; and (C) in exercising the option to discontinue coverage of this type and in offering the option of coverage under subparagraph (B), the issuer acts uniformly without regard to any health status−related factor of enrolled individuals or individuals who may become eligible for such coverage. (2) Discontinuance of all coverage (A) In general Subject to subparagraph (C), in any case in which a health insurance issuer elects to discontinue offering all health insurance coverage in the individual market in a State, health insurance coverage may be discontinued by the issuer only if − (i) the issuer provides notice to the applicable State authority and to each individual of such discontinuation at least 180 days prior to the date of the expiration of such coverage, and (ii) all health insurance issued or delivered for issuance in the State in such market are discontinued and coverage under such health insurance coverage in such market is not renewed. (B) Prohibition on market reentry
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In the case of a discontinuation under subparagraph (A) in the individual market, the issuer may not provide for the issuance of any health insurance coverage in the market and State involved during the 5−year period beginning on the date of the discontinuation of the last health insurance coverage not so renewed. (d) Exception for uniform modification of coverage At the time of coverage renewal, a health insurance issuer may modify the health insurance coverage for a policy form offered to individuals in the individual market so long as such modification is consistent with State law and effective on a uniform basis among all individuals with that policy form. (e) Application to coverage offered only through associations In applying this section in the case of health insurance coverage that is made available by a health insurance issuer in the individual market to individuals only through one or more associations, a reference to an "individual" is deemed to include a reference to such an association (of which the individual is a member). −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2742, as added Pub. L. 104−191, title I, Sec. 111(a), Aug. 21, 1996, 110 Stat. 1982.) −MISC1− EFFECTIVE DATE Section applicable with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the
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individual market after June 30, 1997, regardless of when a period of creditable coverage occurs, see section 111(b) of Pub. L. 104−191, set out as a note under section 300gg−41 of this title. −End− −CITE− 42 USC Sec. 300gg−43 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 1 − portability, access, and renewability requirements −HEAD− Sec. 300gg−43. Certification of coverage −STATUTE− The provisions of section 300gg(e) of this title shall apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner as it applies to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the small or large group market. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2743, as added Pub. L. 104−191, title I, Sec. 111(a), Aug. 21, 1996, 110 Stat. 1983.) −MISC1− EFFECTIVE DATE
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Section applicable with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs, and provisions of section 102(c)(2) of Pub. L. 104−191, set out as a note under section 300gg of this title, applicable to this section in the same manner as it applies to section 300gg(e) of this title, see section 111(b) of Pub. L. 104−191, set out as a note under section 300gg−41 of this title. −End− −CITE− 42 USC Sec. 300gg−44 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 1 − portability, access, and renewability requirements −HEAD− Sec. 300gg−44. State flexibility in individual market reforms −STATUTE− (a) Waiver of requirements where implementation of acceptable alternative mechanism (1) In general The requirements of section 300gg−41 of this title shall not apply with respect to health insurance coverage offered in the individual market in the State so long as a State is found to be
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implementing, in accordance with this section and consistent with section 300gg−62(b) of this title, an alternative mechanism (in this section referred to as an "acceptable alternative mechanism") − (A) under which all eligible individuals are provided a choice of health insurance coverage; (B) under which such coverage does not impose any preexisting condition exclusion with respect to such coverage; (C) under which such choice of coverage includes at least one policy form of coverage that is comparable to comprehensive health insurance coverage offered in the individual market in such State or that is comparable to a standard option of coverage available under the group or individual health insurance laws of such State; and (D) in a State which is implementing − (i) a model act described in subsection (c)(1) of this section, (ii) a qualified high risk pool described in subsection (c)(2) of this section, or (iii) a mechanism described in subsection (c)(3) of this section. (2) Permissible forms of mechanisms A private or public individual health insurance mechanism (such as a health insurance coverage pool or programs, mandatory group conversion policies, guaranteed issue of one or more plans of individual health insurance coverage, or open enrollment by one
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or more health insurance issuers), or combination of such mechanisms, that is designed to provide access to health benefits for individuals in the individual market in the State in accordance with this section may constitute an acceptable alternative mechanism. (b) Application of acceptable alternative mechanisms (1) Presumption (A) In general Subject to the succeeding provisions of this subsection, a State is presumed to be implementing an acceptable alternative mechanism in accordance with this section as of July 1, 1997, if, by not later than April 1, 1997, the chief executive officer of a State − (i) notifies the Secretary that the State has enacted or intends to enact (by not later than January 1, 1998, or July 1, 1998, in the case of a State described in subparagraph (B)(ii)) any necessary legislation to provide for the implementation of a mechanism reasonably designed to be an acceptable alternative mechanism as of January 1, 1998,(!1) (or, in the case of a State described in subparagraph (B)(ii), July 1, 1998); and (ii) provides the Secretary with such information as the Secretary may require to review the mechanism and its implementation (or proposed implementation) under this subsection. (B) Delay permitted for certain States
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(i) Effect of delay In the case of a State described in clause (ii) that provides notice under subparagraph (A)(i), for the presumption to continue on and after July 1, 1998, the chief executive officer of the State by April 1, 1998 − (I) must notify the Secretary that the State has enacted any necessary legislation to provide for the implementation of a mechanism reasonably designed to be an acceptable alternative mechanism as of July 1, 1998; and (II) must provide the Secretary with such information as the Secretary may require to review the mechanism and its implementation (or proposed implementation) under this subsection. (ii) States described A State described in this clause is a State that has a legislature that does not meet within the 12−month period beginning on August 21, 1996. (C) Continued application In order for a mechanism to continue to be presumed to be an acceptable alternative mechanism, the State shall provide the Secretary every 3 years with information described in subparagraph (A)(ii) or (B)(i)(II) (as the case may be). (2) Notice If the Secretary finds, after review of information provided under paragraph (1) and in consultation with the chief executive officer of the State and the insurance commissioner or chief
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insurance regulatory official of the State, that such a mechanism is not an acceptable alternative mechanism or is not (or no longer) being implemented, the Secretary − (A) shall notify the State of − (i) such preliminary determination, and (ii) the consequences under paragraph (3) of a failure to implement such a mechanism; and (B) shall permit the State a reasonable opportunity in which to modify the mechanism (or to adopt another mechanism) in a manner so that may be an acceptable alternative mechanism or to provide for implementation of such a mechanism. (3) Final determination If, after providing notice and opportunity under paragraph (2), the Secretary finds that the mechanism is not an acceptable alternative mechanism or the State is not implementing such a mechanism, the Secretary shall notify the State that the State is no longer considered to be implementing an acceptable alternative mechanism and that the requirements of section 300gg−41 of this title shall apply to health insurance coverage offered in the individual market in the State, effective as of a date specified in the notice. (4) Limitation on secretarial authority The Secretary shall not make a determination under paragraph (2) or (3) on any basis other than the basis that a mechanism is not an acceptable alternative mechanism or is not being implemented.
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(5) Future adoption of mechanisms If a State, after January 1, 1997, submits the notice and information described in paragraph (1), unless the Secretary makes a finding described in paragraph (3) within the 90−day period beginning on the date of submission of the notice and information, the mechanism shall be considered to be an acceptable alternative mechanism for purposes of this section, effective 90 days after the end of such period, subject to the second sentence of paragraph (1). (c) Provision related to risk (1) Adoption of NAIC models The model act referred to in subsection (a)(1)(D)(i) of this section is the Small Employer and Individual Health Insurance Availability Model Act (adopted by the National Association of Insurance Commissioners on June 3, 1996) insofar as it applies to individual health insurance coverage or the Individual Health Insurance Portability Model Act (also adopted by such Association on such date). (2) Qualified high risk pool For purposes of subsection (a)(1)(D)(ii) of this section, a "qualified high risk pool" described in this paragraph is a high risk pool that − (A) provides to all eligible individuals health insurance coverage (or comparable coverage) that does not impose any preexisting condition exclusion with respect to such coverage for all eligible individuals, and
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(B) provides for premium rates and covered benefits for such coverage consistent with standards included in the NAIC Model Health Plan for Uninsurable Individuals Act (as in effect as of August 21, 1996). (3) Other mechanisms For purposes of subsection (a)(1)(D)(iii) of this section, a mechanism described in this paragraph − (A) provides for risk adjustment, risk spreading, or a risk spreading mechanism (among issuers or policies of an issuer) or otherwise provides for some financial subsidization for eligible individuals, including through assistance to participating issuers; or (B) is a mechanism under which each eligible individual is provided a choice of all individual health insurance coverage otherwise available. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2744, as added Pub. L. 104−191, title I, Sec. 111(a), Aug. 21, 1996, 110 Stat. 1984; amended Pub. L. 104−204, title VI, Sec. 605(b)(1), Sept. 26, 1996, 110 Stat. 2942.) −COD− CODIFICATION August 21, 1996, referred to in subsec. (b)(1)(B)(ii), was in the original "the date of enactment of this Act", which was translated as meaning the date of enactment of Pub. L. 104−191, which enacted this subchapter, to reflect the probable intent of Congress.
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−MISC1− AMENDMENTS 1996 − Subsec. (a)(1). Pub. L. 104−204 made technical amendment to reference in original act which appears in text as reference to section 300gg−62(b) of this title. EFFECTIVE DATE OF 1996 AMENDMENT Section 605(c) of Pub. L. 104−204 provided that: "The amendments made by this section [enacting section 300gg−51 of this title and amending this section and sections 300gg−61 and 300gg−62 of this title] shall apply with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after January 1, 1998." EFFECTIVE DATE Section applicable with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs, see section 111(b) of Pub. L. 104−191, set out as a note under section 300gg−41 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300gg−41, 300gg−45 of this title; title 26 section 35; title 29 section 2918. −FOOTNOTE− (!1) So in original. The comma probably should not appear. −End− −CITE−
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42 USC Sec. 300gg−45 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 1 − portability, access, and renewability requirements −HEAD− Sec. 300gg−45. Promotion of qualified high risk pools −STATUTE− (a) Seed grants to States The Secretary shall provide from the funds appropriated under subsection (c)(1) of this section a grant of up to $1,000,000 to each State that has not created a qualified high risk pool as of August 6, 2002, for the State's costs of creation and initial operation of such a pool. (b) Matching funds for operation of pools (1) In general In the case of a State that has established a qualified high risk pool that − (A) restricts premiums charged under the pool to no more than 150 percent of the premium for applicable standard risk rates; (B) offers a choice of two or more coverage options through the pool; and (C) has in effect a mechanism reasonably designed to ensure continued funding of losses incurred by the State after the end
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of fiscal year 2004 in connection with operation of the pool; the Secretary shall provide, from the funds appropriated under subsection (c)(2) of this section and allotted to the State under paragraph (2), a grant of up to 50 percent of the losses incurred by the State in connection with the operation of the pool. (2) Allotment The amounts appropriated under subsection (c)(2) of this section for a fiscal year shall be made available to the States in accordance with a formula that is based upon the number of uninsured individuals in the States. (c) Funding Out of any money in the Treasury of the United States not otherwise appropriated, there are authorized and appropriated − (1) $20,000,000 for fiscal year 2003 to carry out subsection (a) of this section; and (2) $40,000,000 for each of fiscal years 2003 and 2004 to carry out subsection (b) of this section. Funds appropriated under this subsection for a fiscal year shall remain available for obligation through the end of the following fiscal year. Nothing in this section shall be construed as providing a State with an entitlement to a grant under this section. (d) Qualified high risk pool and State defined For purposes of this section, the term "qualified high risk pool" has the meaning given such term in section 300gg−44(c)(2) of this title and the term "State" means any of the 50 States and the
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District of Columbia. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2745, as added Pub. L. 107−210, div. A, title II, Sec. 201(b), Aug. 6, 2002, 116 Stat. 959.) −MISC1− CONSTRUCTION Nothing in the amendments made by title II of Pub. L. 107−210, other than provisions relating to COBRA continuation coverage and reporting requirements, to be construed as creating a new mandate on any party regarding health insurance coverage, see section 203(f) of Pub. L. 107−210, set out as a Construction of 2002 Amendment note under section 2918 of Title 29, Labor. −End− −CITE− 42 USC subpart 2 − other requirements 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 2 − other requirements −HEAD− SUBPART 2 − OTHER REQUIREMENTS −COD− CODIFICATION
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This subpart was, in the original, subpart 3 of part B of title XXVII of act July 1, 1944, and has been redesignated as subpart 2 for purposes of codification. Another subpart 3 of part B of title XXVII of act July 1, 1944, is classified to subpart 3 (Sec. 300gg−61 et seq.) of part B of this subchapter. −End− −CITE− 42 USC Sec. 300gg−51 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 2 − other requirements −HEAD− Sec. 300gg−51. Standards relating to benefits for mothers and newborns −STATUTE− (a) In general The provisions of section 300gg−4 of this title (other than subsections (d) and (f)) shall apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner as it applies to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the small or large group market. (b) Notice requirement
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A health insurance issuer under this part shall comply with the notice requirement under section 1185(d) of title 29 with respect to the requirements referred to in subsection (a) of this section as if such section applied to such issuer and such issuer were a group health plan. (c) Preemption; exception for health insurance coverage in certain States (1) In general The requirements of this section shall not apply with respect to health insurance coverage if there is a State law (as defined in section 300gg−23(d)(1) of this title) for a State that regulates such coverage that is described in any of the following subparagraphs: (A) Such State law requires such coverage to provide for at least a 48−hour hospital length of stay following a normal vaginal delivery and at least a 96−hour hospital length of stay following a cesarean section. (B) Such State law requires such coverage to provide for maternity and pediatric care in accordance with guidelines established by the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, or other established professional medical associations. (C) Such State law requires, in connection with such coverage for maternity care, that the hospital length of stay for such care is left to the decision of (or required to be made by) the attending provider in consultation with the mother.
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(2) Construction Section 300gg−62(a) of this title shall not be construed as superseding a State law described in paragraph (1). −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2751, as added Pub. L. 104−204, title VI, Sec. 605(a)(4), Sept. 26, 1996, 110 Stat. 2941.) −MISC1− EFFECTIVE DATE Section applicable to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after Jan. 1, 1998, see section 605(c) of Pub. L. 104−204, set out as an Effective Date of 1996 Amendment note under section 300gg−44 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300gg−62 of this title. −End− −CITE− 42 USC Sec. 300gg−52 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 2 − other requirements −HEAD−
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Sec. 300gg−52. Required coverage for reconstructive surgery following mastectomies −STATUTE− The provisions of section 300gg−6 of this title shall apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner as they apply to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the small or large group market. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2752, as added Pub. L. 105−277, div. A, Sec. 101(f) [title IX, Sec. 903(b)], Oct. 21, 1998, 112 Stat. 2681−337, 2681−438.) −MISC1− EFFECTIVE DATE Pub. L. 105−277, div. A, Sec. 101(f) [title IX, Sec. 903(c)(2)], Oct. 21, 1998, 112 Stat. 2681−337, 2681−438, provided that: "The amendment made by subsection (b) [enacting this section] shall apply with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after the date of enactment of this Act [Oct. 21, 1998]." −End− −CITE− 42 USC subpart 3 − general provisions 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE
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CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 3 − general provisions −HEAD− SUBPART 3 − GENERAL PROVISIONS −COD− CODIFICATION Another subpart 3 of part B of title XXVII of act July 1, 1944, is classified to subpart 3 (Sec. 300gg−51) of part B of this subchapter. −End− −CITE− 42 USC Sec. 300gg−61 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 3 − general provisions −HEAD− Sec. 300gg−61. Enforcement −STATUTE− (a) State enforcement (1) State authority Subject to section 300gg−62 of this title, each State may
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require that health insurance issuers that issue, sell, renew, or offer health insurance coverage in the State in the individual market meet the requirements established under this part with respect to such issuers. (2) Failure to implement requirements In the case of a State that fails to substantially enforce the requirements set forth in this part with respect to health insurance issuers in the State, the Secretary shall enforce the requirements of this part under subsection (b) of this section insofar as they relate to the issuance, sale, renewal, and offering of health insurance coverage in the individual market in such State. (b) Secretarial enforcement authority The Secretary shall have the same authority in relation to enforcement of the provisions of this part with respect to issuers of health insurance coverage in the individual market in a State as the Secretary has under section 300gg−22(b)(2) of this title in relation to the enforcement of the provisions of part A of this subchapter with respect to issuers of health insurance coverage in the small group market in the State. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2761, formerly Sec. 2745, as added Pub. L. 104−191, title I, Sec. 111(a), Aug. 21, 1996, 110 Stat. 1986; renumbered Sec. 2761 and amended Pub. L. 104−204, title VI, Sec. 605(a)(2), (b)(2), Sept. 26, 1996, 110 Stat. 2941, 2942.) −MISC1−
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AMENDMENTS 1996 − Subsec. (a)(1). Pub. L. 104−204 made technical amendment to reference in original act which appears in text as reference to section 300gg−62 of this title. EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−204 applicable to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after Jan. 1, 1998, see section 605(c) of Pub. L. 104−204, set out as a note under section 300gg−44 of this title. EFFECTIVE DATE Section applicable with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs, see section 111(b) of Pub. L. 104−191, set out as a note under section 300gg−41 of this title. −End− −CITE− 42 USC Sec. 300gg−62 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 3 − general provisions −HEAD−
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Sec. 300gg−62. Preemption −STATUTE− (a) In general Subject to subsection (b) of this section, nothing in this part (or part C of this subchapter insofar as it applies to this part) shall be construed to prevent a State from establishing, implementing, or continuing in effect standards and requirements unless such standards and requirements prevent the application of a requirement of this part. (b) Rules of construction (1) Nothing in this part (or part C of this subchapter insofar as it applies to this part) shall be construed to affect or modify the provisions of section 1144 of title 29. (2) Nothing in this part (other than section 300gg−51 of this title) shall be construed as requiring health insurance coverage offered in the individual market to provide specific benefits under the terms of such coverage. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2762, formerly Sec. 2746, as added Pub. L. 104−191, title I, Sec. 111(a), Aug. 21, 1996, 110 Stat. 1987; renumbered Sec. 2762 and amended, Pub. L. 104−204, title VI, Sec. 605(a)(2), (b)(3), Sept. 26, 1996, 110 Stat. 2941, 2942.) −MISC1− AMENDMENTS 1996 − Subsec. (b). Pub. L. 104−204, Sec. 605(b)(3), designated
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existing provisions as par. (1) and added par. (2). EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−204 applicable to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market on or after Jan. 1, 1998, see section 605(c) of Pub. L. 104−204, set out as a note under section 300gg−44 of this title. EFFECTIVE DATE Section applicable with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs, see section 111(b) of Pub. L. 104−191, set out as a note under section 300gg−41 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300gg−44, 300gg−51, 300gg−61 of this title. −End− −CITE− 42 USC Sec. 300gg−63 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part B − Individual Market Rules subpart 3 − general provisions
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−HEAD− Sec. 300gg−63. General exceptions −STATUTE− (a) Exception for certain benefits The requirements of this part shall not apply to any health insurance coverage in relation to its provision of excepted benefits described in section 300gg−91(c)(1) of this title. (b) Exception for certain benefits if certain conditions met The requirements of this part shall not apply to any health insurance coverage in relation to its provision of excepted benefits described in paragraph (2), (3), or (4) of section 300gg−91(c) of this title if the benefits are provided under a separate policy, certificate, or contract of insurance. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2763, formerly Sec. 2747, as added Pub. L. 104−191, title I, Sec. 111(a), Aug. 21, 1996, 110 Stat. 1987; renumbered Sec. 2763, Pub. L. 104−204, title VI, Sec. 605(a)(2), Sept. 26, 1996, 110 Stat. 2941.) −MISC1− EFFECTIVE DATE Section applicable with respect to health insurance coverage offered, sold, issued, renewed, in effect, or operated in the individual market after June 30, 1997, regardless of when a period of creditable coverage occurs, see section 111(b) of Pub. L. 104−191, set out as a note under section 300gg−41 of this title. −End−
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−CITE− 42 USC Part C − Definitions; Miscellaneous Provisions 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part C − Definitions; Miscellaneous Provisions −HEAD− PART C − DEFINITIONS; MISCELLANEOUS PROVISIONS −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in sections 300gg−23, 300gg−62 of this title. −End− −CITE− 42 USC Sec. 300gg−91 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part C − Definitions; Miscellaneous Provisions −HEAD− Sec. 300gg−91. Definitions −STATUTE− (a) Group health plan (1) Definition
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The term "group health plan" means an employee welfare benefit plan (as defined in section 3(1) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(1)]) to the extent that the plan provides medical care (as defined in paragraph (2)) and including items and services paid for as medical care) to employees or their dependents (as defined under the terms of the plan) directly or through insurance, reimbursement, or otherwise. (2) Medical care The term "medical care" means amounts paid for − (A) the diagnosis, cure, mitigation, treatment, or prevention of disease, or amounts paid for the purpose of affecting any structure or function of the body, (B) amounts paid for transportation primarily for and essential to medical care referred to in subparagraph (A), and (C) amounts paid for insurance covering medical care referred to in subparagraphs (A) and (B). (3) Treatment of certain plans as group health plan for notice provision A program under which creditable coverage described in subparagraph (C), (D), (E), or (F) of section 300gg(c)(1) of this title is provided shall be treated as a group health plan for purposes of applying section 300gg(e) of this title. (b) Definitions relating to health insurance (1) Health insurance coverage The term "health insurance coverage" means benefits consisting of medical care (provided directly, through insurance or
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reimbursement, or otherwise and including items and services paid for as medical care) under any hospital or medical service policy or certificate, hospital or medical service plan contract, or health maintenance organization contract offered by a health insurance issuer. (2) Health insurance issuer The term "health insurance issuer" means an insurance company, insurance service, or insurance organization (including a health maintenance organization, as defined in paragraph (3)) which is licensed to engage in the business of insurance in a State and which is subject to State law which regulates insurance (within the meaning of section 514(b)(2) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1144(b)(2)]). Such term does not include a group health plan. (3) Health maintenance organization The term "health maintenance organization" means − (A) a Federally qualified health maintenance organization (as defined in section 300e(a) of this title), (B) an organization recognized under State law as a health maintenance organization, or (C) a similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization. (4) Group health insurance coverage The term "group health insurance coverage" means, in connection with a group health plan, health insurance coverage offered in
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connection with such plan. (5) Individual health insurance coverage The term "individual health insurance coverage" means health insurance coverage offered to individuals in the individual market, but does not include short−term limited duration insurance. (c) Excepted benefits For purposes of this subchapter, the term "excepted benefits" means benefits under one or more (or any combination thereof) of the following: (1) Benefits not subject to requirements (A) Coverage only for accident, or disability income insurance, or any combination thereof. (B) Coverage issued as a supplement to liability insurance. (C) Liability insurance, including general liability insurance and automobile liability insurance. (D) Workers' compensation or similar insurance. (E) Automobile medical payment insurance. (F) Credit−only insurance. (G) Coverage for on−site medical clinics. (H) Other similar insurance coverage, specified in regulations, under which benefits for medical care are secondary or incidental to other insurance benefits. (2) Benefits not subject to requirements if offered separately (A) Limited scope dental or vision benefits. (B) Benefits for long−term care, nursing home care, home health
531
care, community−based care, or any combination thereof. (C) Such other similar, limited benefits as are specified in regulations. (3) Benefits not subject to requirements if offered as independent, noncoordinated benefits (A) Coverage only for a specified disease or illness. (B) Hospital indemnity or other fixed indemnity insurance. (4) Benefits not subject to requirements if offered as separate insurance policy Medicare supplemental health insurance (as defined under section 1395ss(g)(1) of this title), coverage supplemental to the coverage provided under chapter 55 of title 10, and similar supplemental coverage provided to coverage under a group health plan. (d) Other definitions (1) Applicable State authority The term "applicable State authority" means, with respect to a health insurance issuer in a State, the State insurance commissioner or official or officials designated by the State to enforce the requirements of this subchapter for the State involved with respect to such issuer. (2) Beneficiary The term "beneficiary" has the meaning given such term under section 3(8) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(8)]. (3) Bona fide association
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The term "bona fide association" means, with respect to health insurance coverage offered in a State, an association which − (A) has been actively in existence for at least 5 years; (B) has been formed and maintained in good faith for purposes other than obtaining insurance; (C) does not condition membership in the association on any health status−related factor relating to an individual (including an employee of an employer or a dependent of an employee); (D) makes health insurance coverage offered through the association available to all members regardless of any health status−related factor relating to such members (or individuals eligible for coverage through a member); (E) does not make health insurance coverage offered through the association available other than in connection with a member of the association; and (F) meets such additional requirements as may be imposed under State law. (4) COBRA continuation provision The term "COBRA continuation provision" means any of the following: (A) Section 4980B of title 26, other than subsection (f)(1) of such section insofar as it relates to pediatric vaccines. (B) Part 6 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1161 et seq.], other than section 609 of such Act [29 U.S.C. 1169].
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(C) Subchapter XX of this chapter. (5) Employee The term "employee" has the meaning given such term under section 3(6) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(6)]. (6) Employer The term "employer" has the meaning given such term under section 3(5) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(5)], except that such term shall include only employers of two or more employees. (7) Church plan The term "church plan" has the meaning given such term under section 3(33) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(33)]. (8) Governmental plan (A) The term "governmental plan" has the meaning given such term under section 3(32) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(32)] and any Federal governmental plan. (B) Federal governmental plan. − The term "Federal governmental plan" means a governmental plan established or maintained for its employees by the Government of the United States or by any agency or instrumentality of such Government. (C) Non−Federal governmental plan. − The term "non−Federal governmental plan" means a governmental plan that is not a Federal governmental plan.
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(9) Health status−related factor The term "health status−related factor" means any of the factors described in section 300gg−1(a)(1) of this title. (10) Network plan The term "network plan" means health insurance coverage of a health insurance issuer under which the financing and delivery of medical care (including items and services paid for as medical care) are provided, in whole or in part, through a defined set of providers under contract with the issuer. (11) Participant The term "participant" has the meaning given such term under section 3(7) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(7)]. (12) Placed for adoption defined The term "placement", or being "placed", for adoption, in connection with any placement for adoption of a child with any person, means the assumption and retention by such person of a legal obligation for total or partial support of such child in anticipation of adoption of such child. The child's placement with such person terminates upon the termination of such legal obligation. (13) Plan sponsor The term "plan sponsor" has the meaning given such term under section 3(16)(B) of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1002(16)(B)]. (14) State
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The term "State" means each of the several States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands. (e) Definitions relating to markets and small employers For purposes of this subchapter: (1) Individual market (A) In general The term "individual market" means the market for health insurance coverage offered to individuals other than in connection with a group health plan. (B) Treatment of very small groups (i) In general Subject to clause (ii), such terms (!1) includes coverage offered in connection with a group health plan that has fewer than two participants as current employees on the first day of the plan year. (ii) State exception Clause (i) shall not apply in the case of a State that elects to regulate the coverage described in such clause as coverage in the small group market. (2) Large employer The term "large employer" means, in connection with a group health plan with respect to a calendar year and a plan year, an employer who employed an average of at least 51 employees on business days during the preceding calendar year and who employs at least 2 employees on the first day of the plan year.
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(3) Large group market The term "large group market" means the health insurance market under which individuals obtain health insurance coverage (directly or through any arrangement) on behalf of themselves (and their dependents) through a group health plan maintained by a large employer. (4) Small employer The term "small employer" means, in connection with a group health plan with respect to a calendar year and a plan year, an employer who employed an average of at least 2 but not more than 50 employees on business days during the preceding calendar year and who employs at least 2 employees on the first day of the plan year. (5) Small group market The term "small group market" means the health insurance market under which individuals obtain health insurance coverage (directly or through any arrangement) on behalf of themselves (and their dependents) through a group health plan maintained by a small employer. (6) Application of certain rules in determination of employer size For purposes of this subsection − (A) Application of aggregation rule for employers all (!2) persons treated as a single employer under subsection (b), (c), (m), or (o) of section 414 of title 26 shall be treated as 1 employer.
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(B) Employers not in existence in preceding year In the case of an employer which was not in existence throughout the preceding calendar year, the determination of whether such employer is a small or large employer shall be based on the average number of employees that it is reasonably expected such employer will employ on business days in the current calendar year. (C) Predecessors Any reference in this subsection to an employer shall include a reference to any predecessor of such employer. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2791, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1972.) −REFTEXT− REFERENCES IN TEXT The Employee Retirement Income Security Act of 1974, referred to in subsec. (d)(4)(B), is Pub. L. 93−406, Sept. 2, 1974, 88 Stat. 829, as amended. Part 6 of subtitle B of title I of the Act is classified generally to part 6 (Sec. 1161 et seq.) of subtitle B of subchapter I of chapter 18 of Title 29, Labor. For complete classification of this Act to the Code, see Short Title note set out under section 1001 of Title 29 and Tables. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300e, 300gg, 300gg−11, 300gg−21, 300gg−41, 300gg−63, 1320d, 1397cc, 1397ii, 1397jj of this
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title; title 21 section 360aaa−5. −FOOTNOTE− (!1) So in original. Probably should be "term". (!2) So in original. Probably should be capitalized. −End− −CITE− 42 USC Sec. 300gg−92 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXV − REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE Part C − Definitions; Miscellaneous Provisions −HEAD− Sec. 300gg−92. Regulations −STATUTE− The Secretary, consistent with section 104 of the Health Care Portability and Accountability Act of 1996, may promulgate such regulations as may be necessary or appropriate to carry out the provisions of this subchapter. The Secretary may promulgate any interim final rules as the Secretary determines are appropriate to carry out this subchapter. −SOURCE− (July 1, 1944, ch. 373, title XXVII, Sec. 2792, as added Pub. L. 104−191, title I, Sec. 102(a), Aug. 21, 1996, 110 Stat. 1976.) −REFTEXT− REFERENCES IN TEXT
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Section 104 of the Health Care Portability and Accountability Act of 1996, referred to in text, probably means section 104 of the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104−191, set out below. −MISC1− ASSURING COORDINATION AMONG DEPARTMENTS OF TREASURY, HEALTH AND HUMAN SERVICES, AND LABOR Section 104 of Pub. L. 104−191 provided that: "The Secretary of the Treasury, the Secretary of Health and Human Services, and the Secretary of Labor shall ensure, through the execution of an interagency memorandum of understanding among such Secretaries, that − "(1) regulations, rulings, and interpretations issued by such Secretaries relating to the same matter over which two or more such Secretaries have responsibility under this subtitle [subtitle A (Secs. 101−104) of title I of Pub. L. 104−191, enacting this section, sections 300gg, 300gg−1, 300gg−11 to 300gg−13, 300gg−21 to 300gg−23, and 300gg−91 of this title, and sections 1181 to 1183 and 1191 to 1191c of Title 29, Labor, amending sections 300e and 300bb−8 of this title and sections 1003, 1021, 1022, 1024, 1132, 1136, and 1144 of Title 29, and enacting provisions set out as notes under section 300gg of this title and section 1181 of Title 29] (and the amendments made by this subtitle and section 401 [enacting sections 9801 to 9806 of Title 26, Internal Revenue Code]) are administered so as to have the same effect at all times; and
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"(2) coordination of policies relating to enforcing the same requirements through such Secretaries in order to have a coordinated enforcement strategy that avoids duplication of enforcement efforts and assigns priorities in enforcement." −End− −CITE− 42 USC SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES −HEAD− SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES −End− −CITE− 42 USC Part A − National Preparedness and Response Planning, Coordinating, and Reporting 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER
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PUBLIC HEALTH EMERGENCIES Part A − National Preparedness and Response Planning, Coordinating, and Reporting −HEAD− PART A − NATIONAL PREPAREDNESS AND RESPONSE PLANNING, COORDINATING, AND REPORTING −End− −CITE− 42 USC Sec. 300hh 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES Part A − National Preparedness and Response Planning, Coordinating, and Reporting −HEAD− Sec. 300hh. National preparedness plan −STATUTE− (a) In general (1) Preparedness and response regarding public health emergencies The Secretary shall further develop and implement a coordinated strategy, building upon the core public health capabilities established pursuant to section 247d−1 of this title, for carrying out health−related activities to prepare for and respond effectively to bioterrorism and other public health emergencies,
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including the preparation of a plan under this section. The Secretary shall periodically thereafter review and, as appropriate, revise the plan. (2) National approach In carrying out paragraph (1), the Secretary shall collaborate with the States toward the goal of ensuring that the activities of the Secretary regarding bioterrorism and other public health emergencies are coordinated with activities of the States, including local governments. (3) Evaluation of progress The plan under paragraph (1) shall provide for specific benchmarks and outcome measures for evaluating the progress of the Secretary and the States, including local governments, with respect to the plan under paragraph (1), including progress toward achieving the goals specified in subsection (b) of this section. (b) Preparedness goals The plan under subsection (a) of this section should include provisions in furtherance of the following: (1) Providing effective assistance to State and local governments in the event of bioterrorism or other public health emergency. (2) Ensuring that State and local governments have appropriate capacity to detect and respond effectively to such emergencies, including capacities for the following: (A) Effective public health surveillance and reporting
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mechanisms at the State and local levels. (B) Appropriate laboratory readiness. (C) Properly trained and equipped emergency response, public health, and medical personnel. (D) Health and safety protection of workers responding to such an emergency. (E) Public health agencies that are prepared to coordinate health services (including mental health services) during and after such emergencies. (F) Participation in communications networks that can effectively disseminate relevant information in a timely and secure manner to appropriate public and private entities and to the public. (3) Developing and maintaining medical countermeasures (such as drugs, vaccines and other biological products, medical devices, and other supplies) against biological agents and toxins that may be involved in such emergencies. (4) Ensuring coordination and minimizing duplication of Federal, State, and local planning, preparedness, and response activities, including during the investigation of a suspicious disease outbreak or other potential public health emergency. (5) Enhancing the readiness of hospitals and other health care facilities to respond effectively to such emergencies. (c) Reports to Congress (1) In general Not later than one year after June 12, 2002, and biennially
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thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report concerning progress with respect to the plan under subsection (a) of this section, including progress toward achieving the goals specified in subsection (b) of this section. (2) Additional authority Reports submitted under paragraph (1) by the Secretary (other than the first report) shall make recommendations concerning − (A) any additional legislative authority that the Secretary determines is necessary for fully implementing the plan under subsection (a) of this section, including meeting the goals under subsection (b) of this section; and (B) any additional legislative authority that the Secretary determines is necessary under section 247d of this title to protect the public health in the event of an emergency described in section 247d(a) of this title. (d) Rule of construction This section may not be construed as expanding or limiting any of the authorities of the Secretary that, on the day before June 12, 2002, were in effect with respect to preparing for and responding effectively to bioterrorism and other public health emergencies. −SOURCE− (July 1, 1944, ch. 373, title XXVIII, Sec. 2801, as added Pub. L. 107−188, title I, Sec. 101(a), June 12, 2002, 116 Stat. 596.) −MISC1−
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GENERAL ACCOUNTING OFFICE REPORT Pub. L. 107−188, title I, Sec. 157, June 12, 2002, 116 Stat. 633, provided that: "(a) In General [sic]. − The Comptroller General shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a report that describes − "(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population; "(2) the coordination of the activities described in paragraph (1); "(3) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population; "(4) the activities and costs of the Civil Support Teams of the National Guard in responding to biological threats or attacks against the civilian population; "(5) the activities of the working group under subsection (a) and the efforts made by such group to carry out the activities described in such subsection; and "(6) the ability of private sector contractors to enhance governmental responses to biological threats or attacks."
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−End− −CITE− 42 USC Part B − Emergency Preparedness and Response 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES Part B − Emergency Preparedness and Response −HEAD− PART B − EMERGENCY PREPAREDNESS AND RESPONSE −End− −CITE− 42 USC Sec. 300hh−11 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES Part B − Emergency Preparedness and Response −HEAD− Sec. 300hh−11. Coordination of preparedness for and response to bioterrorism and other public health emergencies −STATUTE− (a) Assistant Secretary for Public Health Emergency Preparedness (1) In general
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There is established within the Department of Health and Human Services the position of Assistant Secretary for Public Health Emergency Preparedness. The President shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Secretary. (2) Duties Subject to the authority of the Secretary, the Assistant Secretary for Public Health Emergency Preparedness shall carry out the following duties with respect to bioterrorism and other public health emergencies: (A) Coordinate on behalf of the Secretary − (i) interagency interfaces between the Department of Health and Human Services (referred to in this paragraph as the "Department") and other departments, agencies, and offices of the United States; and (ii) interfaces between the Department and State and local entities with responsibility for emergency preparedness. (B) Coordinate the operations of the National Disaster Medical System and any other emergency response activities within the Department of Health and Human Services that are related to bioterrorism and other public health emergencies. (C) Coordinate the efforts of the Department to bolster State and local emergency preparedness for a bioterrorist attack or other public health emergency, and evaluate the progress of such entities in meeting the benchmarks and other outcome measures contained in the national plan and in meeting the core
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public health capabilities established pursuant to 247d−1 (!1) of this title. (D) Any other duties determined appropriate by the Secretary. (b) National Disaster Medical System (1) In general The Secretary shall provide for the operation in accordance with this section of a system to be known as the National Disaster Medical System. The Secretary shall designate the Assistant Secretary for Public Health Emergency Preparedness as the head of the National Disaster Medical System, subject to the authority of the Secretary. (2) Federal and State collaborative System (A) In general The National Disaster Medical System shall be a coordinated effort by the Federal agencies specified in subparagraph (B), working in collaboration with the States and other appropriate public or private entities, to carry out the purposes described in paragraph (3). (B) Participating Federal agencies The Federal agencies referred to in subparagraph (A) are the Department of Health and Human Services, the Federal Emergency Management Agency, the Department of Defense, and the Department of Veterans Affairs. (3) Purpose of System (A) In general The Secretary may activate the National Disaster Medical
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System to − (i) provide health services, health−related social services, other appropriate human services, and appropriate auxiliary services to respond to the needs of victims of a public health emergency (whether or not determined to be a public health emergency under section 247d of this title); or (ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of a public health emergency during the time specified. (B) Ongoing activities The National Disaster Medical System shall carry out such ongoing activities as may be necessary to prepare for the provision of services described in subparagraph (A) in the event that the Secretary activates the National Disaster Medical System for such purposes. (C) Test for mobilization of System During the one−year period beginning on June 12, 2002, the Secretary shall conduct an exercise to test the capability and timeliness of the National Disaster Medical System to mobilize and otherwise respond effectively to a bioterrorist attack or other public health emergency that affects two or more geographic locations concurrently. Thereafter, the Secretary may periodically conduct such exercises regarding the National Disaster Medical System as the Secretary determines to be appropriate.
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(c) Criteria (1) In general The Secretary shall establish criteria for the operation of the National Disaster Medical System. (2) Participation agreements for non−Federal entities In carrying out paragraph (1), the Secretary shall establish criteria regarding the participation of States and private entities in the National Disaster Medical System, including criteria regarding agreements for such participation. The criteria shall include the following: (A) Provisions relating to the custody and use of Federal personal property by such entities, which may in the discretion of the Secretary include authorizing the custody and use of such property to respond to emergency situations for which the National Disaster Medical System has not been activated by the Secretary pursuant to subsection (b)(3)(A) of this section. Any such custody and use of Federal personal property shall be on a reimbursable basis. (B) Provisions relating to circumstances in which an individual or entity has agreements with both the National Disaster Medical System and another entity regarding the provision of emergency services by the individual. Such provisions shall address the issue of priorities among the agreements involved. (d) Intermittent disaster−response personnel (1) In general
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For the purpose of assisting the National Disaster Medical System in carrying out duties under this section, the Secretary may appoint individuals to serve as intermittent personnel of such System in accordance with applicable civil service laws and regulations. (2) Liability For purposes of section 233(a) of this title and the remedies described in such section, an individual appointed under paragraph (1) shall, while acting within the scope of such appointment, be considered to be an employee of the Public Health Service performing medical, surgical, dental, or related functions. With respect to the participation of individuals appointed under paragraph (1) in training programs authorized by the Assistant Secretary for Public Health Emergency Preparedness or a comparable official of any Federal agency specified in subsection (b)(2)(B) of this section, acts of individuals so appointed that are within the scope of such participation shall be considered within the scope of the appointment under paragraph (1) (regardless of whether the individuals receive compensation for such participation). (e) Certain employment issues regarding intermittent appointments (1) Intermittent disaster−response appointee For purposes of this subsection, the term "intermittent disaster−response appointee" means an individual appointed by the Secretary under subsection (d) of this section. (2) Compensation for work injuries
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An intermittent disaster−response appointee shall, while acting in the scope of such appointment, be considered to be an employee of the Public Health Service performing medical, surgical, dental, or related functions, and an injury sustained by such an individual shall be deemed "in the performance of duty", for purposes of chapter 81 of title 5 pertaining to compensation for work injuries. With respect to the participation of individuals appointed under subsection (d) of this section in training programs authorized by the Assistant Secretary for Public Health Emergency Preparedness or a comparable official of any Federal agency specified in subsection (b)(2)(B) of this section, injuries sustained by such an individual, while acting within the scope of such participation, also shall be deemed "in the performance of duty" for purposes of chapter 81 of title 5 (regardless of whether the individuals receive compensation for such participation). In the event of an injury to such an intermittent disaster−response appointee, the Secretary of Labor shall be responsible for making determinations as to whether the claimant is entitled to compensation or other benefits in accordance with chapter 81 of title 5. (3) Employment and reemployment rights (A) In general Service as an intermittent disaster−response appointee when the Secretary activates the National Disaster Medical System or when the individual participates in a training program authorized by the Assistant Secretary for Public Health
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Emergency Preparedness or a comparable official of any Federal agency specified in subsection (b)(2)(B) of this section shall be deemed "service in the uniformed services" for purposes of chapter 43 of title 38 pertaining to employment and reemployment rights of individuals who have performed service in the uniformed services (regardless of whether the individual receives compensation for such participation). All rights and obligations of such persons and procedures for assistance, enforcement, and investigation shall be as provided for in chapter 43 of title 38. (B) Notice of absence from position of employment Preclusion of giving notice of service by necessity of Service as an intermittent disaster−response appointee when the Secretary activates the National Disaster Medical System shall be deemed preclusion by "military necessity" for purposes of section 4312(b) of title 38 pertaining to giving notice of absence from a position of employment. A determination of such necessity shall be made by the Secretary, in consultation with the Secretary of Defense, and shall not be subject to judicial review. (4) Limitation An intermittent disaster−response appointee shall not be deemed an employee of the Department of Health and Human Services for purposes other than those specifically set forth in this section. (f) Rule of construction regarding use of commissioned corps If the Secretary assigns commissioned officers of the Regular or
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Reserve Corps to serve with the National Disaster Medical System, such assignments do not affect the terms and conditions of their appointments as commissioned officers of the Regular or Reserve Corps, respectively (including with respect to pay and allowances, retirement, benefits, rights, privileges, and immunities). (g) Definition For purposes of this section, the term "auxiliary services" includes mortuary services, veterinary services, and other services that are determined by the Secretary to be appropriate with respect to the needs referred to in subsection (b)(3)(A) of this section. (h) Authorization of appropriations For the purpose of providing for the Assistant Secretary for Public Health Emergency Preparedness and the operations of the National Disaster Medical System, other than purposes for which amounts in the Public Health Emergency Fund under section 247d of this title are available, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006. −SOURCE− (July 1, 1944, ch. 373, title XXVIII, Sec. 2811, as added Pub. L. 107−188, title I, Sec. 102(a), June 12, 2002, 116 Stat. 599.) −REFTEXT− REFERENCES IN TEXT The civil service laws, referred to in subsec. (d)(1), are classified generally to Title 5, Government Organization and Employees. See, particularly, section 3301 et seq. of Title 5.
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−TRANS− TRANSFER OF FUNCTIONS For transfer of functions, personnel, assets, and liabilities of the National Disaster Medical System of the Department of Health and Human Services, including the functions of the Secretary of Health and Human Services and the Assistant Secretary for Public Health Emergency Preparedness relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 313(5), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6. For transfer of functions, personnel, assets, and liabilities of the Federal Emergency Management Agency, including the functions of the Director of the Federal Emergency Management Agency relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 313(1), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in title 38 sections 1785, 7325, 8111A, 8117. −FOOTNOTE− (!1) So in original. Probably should be preceded by "section".
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−End− −CITE− 42 USC Sec. 300hh−12 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES Part B − Emergency Preparedness and Response −HEAD− Sec. 300hh−12. Strategic national stockpile −STATUTE− (a) Strategic national stockpile (1) In general The Secretary of Homeland Security (referred to in this section as the "Secretary"), in coordination with the Secretary of Health and Human Services and the Secretary of Veterans Affairs, shall maintain a stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other supplies in such numbers, types, and amounts as are determined by the Secretary of Health and Human Services to be appropriate and practicable, taking into account other available sources, to provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.
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(2) Procedures The Secretary of Health and Human Services, in managing the stockpile under paragraph (1), shall − (A) consult with the working group under section 247d−6(a) of this title; (B) ensure that adequate procedures are followed with respect to such stockpile for inventory management and accounting, and for the physical security of the stockpile; (C) in consultation with Federal, State, and local officials, take into consideration the timing and location of special events; (D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that emerging threats, advanced technologies, and new countermeasures are adequately considered; (E) devise plans for the effective and timely supply−chain management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the public and private health care infrastructure; and (F) ensure the adequate physical security of the stockpile. (b) Smallpox vaccine development (1) In general The Secretary of Health and Human Services shall award contracts, enter into cooperative agreements, or carry out such other activities as may reasonably be required in order to ensure that the stockpile under subsection (a) of this section includes
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an amount of vaccine against smallpox as determined by the Secretary of Health and Human Services to be sufficient to meet the health security needs of the United States. (2) Rule of construction Nothing in this section shall be construed to limit the private distribution, purchase, or sale of vaccines from sources other than the stockpile described in subsection (a) of this section. (c) Disclosures No Federal agency shall disclose under section 552 (!1) any information identifying the location at which materials in the stockpile under subsection (a) of this section are stored. (d) Definition For purposes of subsection (a) of this section, the term "stockpile" includes − (1) a physical accumulation (at one or more locations) of the supplies described in subsection (a) of this section; or (2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or vendors agree to provide to the Secretary supplies described in subsection (a) of this section. (e) Authorization of appropriations (1) Strategic National Stockpile For the purpose of carrying out subsection (a) of this section, there are authorized to be appropriated $640,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006.
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(2) Smallpox vaccine development For the purpose of carrying out subsection (b) of this section, there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006. −SOURCE− (Pub. L. 107−188, title I, Sec. 121, June 12, 2002, 116 Stat. 611; Pub. L. 107−296, title XVII, Sec. 1705(a), Nov. 25, 2002, 116 Stat. 2316.) −COD− CODIFICATION Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Public Health Service Act which comprises this chapter. −MISC1− AMENDMENTS 2002 − Subsec. (a)(1). Pub. L. 107−296, Sec. 1705(a)(1), substituted "The Secretary of Homeland Security" for "The Secretary of Health and Human Services" and inserted "the Secretary of Health and Human Services and" after "in coordination with" and "of Health and Human Services" after "as are determined by the Secretary". Subsecs. (a)(2), (b)(1). Pub. L. 107−296, Sec. 1705(a)(2), inserted "of Health and Human Services" after "Secretary" wherever appearing. EFFECTIVE DATE OF 2002 AMENDMENT Pub. L. 107−296, title XVII, Sec. 1705(b), Nov. 25, 2002, 116
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Stat. 2316, provided that: "The amendments made by this section [amending this section] shall take effect on the date of transfer of the Strategic National Stockpile of the Department of Health and Human Services to the Department [of Homeland Security]." −TRANS− TRANSFER OF FUNCTIONS For transfer of functions, personnel, assets, and liabilities of the Strategic National Stockpile of the Department of Health and Human Services, including the functions of the Secretary of Health and Human Services relating thereto, to the Secretary of Homeland Security, and for treatment of related references, see sections 313(6), 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6. −MISC2− POTASSIUM IODIDE Pub. L. 107−188, title I, Sec. 127, June 12, 2002, 116 Stat. 615, provided that: "(a) In General. − Through the national stockpile under section 121 [this section], the President, subject to subsections (b) and (c), shall make available to State and local governments potassium iodide tablets for stockpiling and for distribution as appropriate to public facilities, such as schools and hospitals, in quantities sufficient to provide adequate protection for the population within 20 miles of a nuclear power plant.
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"(b) State and Local Plans. − "(1) In general. − Subsection (a) applies with respect to a State or local government, subject to paragraph (2), if the government involved meets the following conditions: "(A) Such government submits to the President a plan for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident. "(B) The plan is accompanied by certifications by such government that the government has not already received sufficient quantities of potassium iodide tablets from the Federal Government. "(2) Local governments. − Subsection (a) applies with respect to a local government only if, in addition to the conditions described in paragraph (1), the following conditions are met: "(A) The State in which the locality involved is located − "(i) does not have a plan described in paragraph (1)(A); or "(ii) has a plan described in such paragraph, but the plan does not address populations at a distance greater than 10 miles from the nuclear power plant involved. "(B) The local government has petitioned the State to modify the State plan to address such populations, not exceeding 20 miles from such plant, and 60 days have elapsed without the State modifying the State plan to address populations at the full distance sought by the local government through the petition.
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"(C) The local government has submitted its local plan under paragraph (1)(A) to the State, and the State has approved the plan and certified that the plan is not inconsistent with the State emergency plan. "(c) Guidelines. − Not later than one year after the date of the enactment of this Act [June 12, 2002], the President, in consultation with individuals representing appropriate Federal, State, and local agencies, shall establish guidelines for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident. Such tablets may not be made available under subsection (a) until such guidelines have been established. "(d) Information. − The President shall carry out activities to inform State and local governments of the program under this section. "(e) Reports. − "(1) President. − Not later than six months after the date on which the guidelines under subsection (c) are issued, the President shall submit to the Congress a report − "(A) on whether potassium iodide tablets have been made available under subsection (a) or other Federal, State, or local programs, and the extent to which State and local governments have established stockpiles of such tablets; and "(B) the measures taken by the President to implement this section. (2) National academy of sciences. −
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"(A) In general. − The President shall request the National Academy of Sciences to enter into an agreement with the President under which the Academy conducts a study to determine what is the most effective and safe way to distribute and administer potassium iodide tablets on a mass scale. If the Academy declines to conduct the study, the President shall enter into an agreement with another appropriate public or nonprofit private entity to conduct the study. "(B) Report. − The President shall ensure that, not later than six months after the date of the enactment of this Act [June 12, 2002], the study required in subparagraph (A) is completed and a report describing the findings made in the study is submitted to the Congress. "(f) Applicability. − Subsections (a) and (d) cease to apply as requirements if the President determines that there is an alternative and more effective prophylaxis or preventive measures for adverse thyroid conditions that may result from the release of radionuclides from nuclear power plants." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 247d−6 of this title. −FOOTNOTE− (!1) So in original. Probably should be followed by "of title 5". −End− −CITE− 42 USC Sec. 300hh−13 01/06/03
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−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES Part B − Emergency Preparedness and Response −HEAD− Sec. 300hh−13. Evaluation of new and emerging technologies regarding bioterrorist attack and other public health emergencies −STATUTE− (a) In general The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall promptly carry out a program to periodically evaluate new and emerging technologies that, in the determination of the Secretary, are designed to improve or enhance the ability of public health or safety officials to conduct public health surveillance activities relating to a bioterrorist attack or other public health emergency. (b) Certain activities In carrying out this subsection, the Secretary shall, to the extent practicable − (1) survey existing technology programs funded by the Federal Government for potentially useful technologies; (2) promptly issue a request, as necessary, for information from non−Federal public and private entities for ongoing activities in this area; and
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(3) evaluate technologies identified under paragraphs (1) and (2) pursuant to subsection (c) of this section. (c) Consultation and evaluation In carrying out subsection (b)(3) of this section, the Secretary shall consult with the working group under section 247d−6(a) of this title, as well as other appropriate public, nonprofit, and private entities, to develop criteria for the evaluation of such technologies and to conduct such evaluations. (d) Report Not later than 180 days after June 12, 2002, and periodically thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the activities under this section. −SOURCE− (Pub. L. 107−188, title I, Sec. 126, June 12, 2002, 116 Stat. 615.) −COD− CODIFICATION Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Public Health Service Act which comprises this chapter. −End− −CITE− 42 USC Secs. 300aaa to 300aaa−13 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE
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CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXVI − NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES Part B − Emergency Preparedness and Response −HEAD− Secs. 300aaa to 300aaa−13. Transferred −COD− CODIFICATION Former title XXVII of the Public Health Service Act was renumbered part B of title II by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and is classified to part B (Sec. 238 et seq.) of subchapter I of this chapter. Section 300aaa, act July 1, 1944, ch. 373, title XXVII, Sec. 2701, formerly title V, Sec. 501, 58 Stat. 709, as amended, which related to gifts for benefit of Service, was renumbered section 231 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238 of this title. Section 300aaa−1, act July 1, 1944, ch. 373, title XXVII, Sec. 2702, formerly title V, Sec. 502, 58 Stat. 710, as amended, which related to use of immigration station hospitals, was renumbered section 232 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238a of this title. Section 300aaa−2, act July 1, 1944, ch. 373, title XXVII, Sec. 2703, formerly title V, Sec. 503, 58 Stat. 710, as amended, which related to disposition of money collected for care of patients, was 567
renumbered section 233 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238b of this title. Section 300aaa−3, act July 1, 1944, ch. 373, title XXVII, Sec. 2704, formerly title V, Sec. 506, 58 Stat. 710, as amended, which related to transportation of remains of officers, was renumbered section 234 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238c of this title. Section 300aaa−4, act July 1, 1944, ch. 373, title XXVII, Sec. 2705, formerly title V, Sec. 507, as added June 24, 1967, Pub. L. 90−31, Sec. 5, 81 Stat. 79, and amended, which related to availability of appropriations for grants to Federal institutions, was renumbered section 235 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238d of this title. Section 300aaa−5, act July 1, 1944, ch. 373, title XXVII, Sec. 2706, formerly title V, Sec. 508, 58 Stat. 711, as amended, which related to transfer of funds for continuance of transferred functions, was renumbered section 236 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238e of this title. Section 300aaa−6, act July 1, 1944, ch. 373, title XXVII, Sec. 2707, formerly title V, Sec. 509, 58 Stat. 711, as amended, which related to availability of appropriations, was renumbered section 237 of title II of act July 1, 1944, by Pub. L. 103−43, title XX,
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Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238f of this title. Section 300aaa−7, act July 1, 1944, ch. 373, title XXVII, Sec. 2708, formerly title V, Sec. 510, 58 Stat. 711, as amended, which related to wearing of uniforms, was renumbered section 238 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238g of this title. Section 300aaa−8, act July 1, 1944, ch. 373, title XXVII, Sec. 2709, formerly title V, Sec. 511, 58 Stat. 711, as amended, which related to annual report of Surgeon General, was renumbered section 239 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238h of this title. Section 300aaa−9, act July 1, 1944, ch. 373, title XXVII, Sec. 2710, formerly title V, Sec. 512, as added Oct. 15, 1968, Pub. L. 90−574, title V, Sec. 503(a), 82 Stat. 1012, and amended, which related to memorials and other acknowledgements for contributions to the health of the Nation, was renumbered section 240 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238i of this title. Section 300aaa−10, act July 1, 1944, ch. 373, title XXVII, Sec. 2711, formerly title V, Sec. 513, as added June 30, 1970, Pub. L. 91−296, title IV, Sec. 401(a), 84 Stat. 351, and amended, which related to evaluation of programs, was renumbered section 241 of
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title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238j of this title. Section 300aaa−11, act July 1, 1944, ch. 373, title XXVII, Sec. 2712, formerly title V, Sec. 514, as added Nov. 9, 1978, Pub. L. 95−623, Sec. 11(e), 92 Stat. 3456, and amended, which related to contract authority, was renumbered section 242 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238k of this title. Section 300aaa−12, act July 1, 1944, ch. 373, title XXVII, Sec. 2713, formerly title V, Sec. 515, formerly Pub. L. 88−164, title II, Sec. 225, as added Pub. L. 94−63, title III, Sec. 303, July 29, 1975, 89 Stat. 326, and amended, which related to recovery by United States of base amount plus interest in certain circumstances, was renumbered section 243 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238l of this title. Section 300aaa−13, act July 1, 1944, ch. 373, title XXVII, Sec. 2714, formerly title XXI, Sec. 2116, as added Apr. 7, 1986, Pub. L. 99−272, title XVII, Sec. 17003, 100 Stat. 359, and amended, which related to use of fiscal agents, was renumbered section 244 of title II of act July 1, 1944, by Pub. L. 103−43, title XX, Sec. 2010(a)(1)−(3), June 10, 1993, 107 Stat. 213, and transferred to section 238m of this title. −End−
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