42 U.S.C. § 299 — Mission and duties

Page 1114 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 298d A prior section 298b–7, act July 1, 1944, ch. 373, title VIII, § 860, as added Pub. L. 102–408, title II, § 209, Oct. 13, 1992, 106 Stat. 2075; amended Pub. L. 102–531, title III, § 313(a)(10), Oct. 27, 1992, 106 Stat. 3507; Pub. L. 103–43, title XX, § 2014(g), June 10, 1993, 107 Stat. 217, set forth certain generally applicable provisions, prior to repeal by Pub. L. 105–392, title I, § 123(1), Nov. 13, 1998, 112 Stat. 3562. A prior section 298c, act July 1, 1944, ch. 373, title VIII, § 860, as added Aug. 16, 1968, Pub. L. 90–490, title II, § 223(a), 82 Stat. 785; amended July 9, 1971, Pub. L. 92–52, § 4, 85 Stat. 145; Nov. 18, 1971, Pub. L. 92–158, § 7, 85 Stat. 478, which related to scholarship grants, was renum- bered section 845 of act July 1, 1944, by Pub. L. 94–63 and transferred to section 297j of this title and subse- quently repealed. Another prior section 298c, act July 1, 1944, ch. 373, title VIII, § 861, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1236, stated the purposes of opportunity grants for nursing education and authorized appropria- tions of $3,000,000, $5,000,000, and $7,000,000 for fiscal years ending June 30, 1967, 1968, and 1969, respectively, to be available for payments to institutions until close of fiscal year succeeding fiscal year for which appro- priated, prior to the reorganization and amendment of this subchapter by Pub. L. 90–490. A prior section 298c–1, act July 1, 1944, ch. 373, title VIII, § 861, as added Aug. 16, 1968, Pub. L. 90–490, title II, § 223(a), 82 Stat. 786, related to transfers to student loan program, was renumbered section 846 of act July 1, 1944, by Pub. L. 94–63 and transferred to section 297k of this title and subsequently repealed. Another prior section 298c–1, act July 1, 1944, ch. 373, title VIII, § 862, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1237, prescribed amount of nursing edu- cational opportunity grant and provided for its annual determination, prior to the reorganization and amend- ment of this subchapter by Pub. L. 90–490. Sections 298c–2 to 298c–6 were omitted in the reorga- nization and amendment of this subchapter by Pub. L. 90–490, title II, § 223, Aug. 16, 1968, 82 Stat. 785. Section 298c–2, act July 1, 1944, ch. 373, title VIII, § 863, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1237, related to duration of a nursing educational op- portunity grant. Section 298c–3, act July 1, 1944, ch. 373, title VIII, § 864, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1238, related to selection of recipients of nursing edu- cational opportunity grants. Section 298c–4, act July 1, 1944, ch. 373, title VIII, § 865, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1238, related to allotment of nursing educational oppor- tunity grant funds among States. Section 298c–5, act July 1, 1944, ch. 373, title VIII, § 866, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1238, related to allocation of allotted funds to schools of nursing. Section 298c–6, act July 1, 1944, ch. 373, title VIII, § 867, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1239, related to agreements with schools of nursing. A prior section 298c–7, act July 1, 1944, ch. 373, title VIII, § 868, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1239; amended Nov. 18, 1971, Pub. L. 92–158, § 8, 85 Stat. 478; July 29, 1975, Pub. L. 94–63, title IX, § 902(g), 89 Stat. 355, authorized grants and contracts to encour- age full utilization of educational talent for nursing profession and authorized appropriations from fiscal year ending June 30, 1972 through fiscal year ending June 30, 1975 for implementation, prior to repeal by Pub. L. 94–63, title IX, §§ 905, 931(b), July 29, 1975, 89 Stat. 355, 362, effective July 1, 1975. A prior section 298c–8, act July 1, 1944, ch. 373, title VIII, § 869, as added Nov. 3, 1966, Pub. L. 89–751, § 8(b), 80 Stat. 1240, defined ‘‘academic year’’, prior to repeal by Pub. L. 94–63, title IX, §§ 941(j)(4), 942, July 29, 1975, 89 Stat. 366, 367, effective July 1, 1975. AMENDMENTS 2010—Subsec. (b)(5). Pub. L. 111–148, § 5305(c)(1), added par. (5). Subsec. (e). Pub. L. 111–148, § 5305(c)(2), substituted ‘‘2010 through 2014’’ for ‘‘2003 through 2007’’. PART I—FUNDING Editorial Notes CODIFICATION Pub. L. 111–148, title V, § 5310(b)(7), Mar. 23, 2010, 124 Stat. 631, redesignated part F ‘‘Funding’’ as I. PRIOR PROVISIONS A prior part I, consisting of section 298, was redesig- nated part H of this subchapter. § 298d. Authorization of appropriations (a) In general For the purpose of carrying out parts B, C, and D (subject to section 297t(g) of this title), there are authorized to be appropriated $137,837,000 for each of fiscal years 2021 through 2025. (b) Part E For the purpose of carrying out part E, there are authorized to be appropriated $117,135,000 for each of the fiscal years 2021 through 2025. (July 1, 1944, ch. 373, title VIII, § 871, formerly § 841, as added Pub. L. 105–392, title I, § 123(5), Nov. 13, 1998, 112 Stat. 3569; renumbered § 871 and amended Pub. L. 111–148, title V, §§ 5310(b)(7), 5312, Mar. 23, 2010, 124 Stat. 631, 633; Pub. L. 116–136, div. A, title III, § 3404(a)(13), Mar. 27, 2020, 134 Stat. 394.) Editorial Notes CODIFICATION Section was classified to section 297q of this title prior to renumbering by Pub. L. 111–148. AMENDMENTS 2020—Pub. L. 116–136 designated existing provisions as subsec. (a) and inserted heading, substituted ‘‘$137,837,000 for each of fiscal years 2021 through 2025’’ for ‘‘$338,000,000 for fiscal year 2010, and such sums as may be necessary for each of the fiscal years 2011 through 2016’’, and added subsec. (b). 2010—Pub. L. 111–148, § 5312, amended section gen- erally. Prior to amendment, section related to author- ization of appropriations for fiscal years 1998 through 2002, allocations of amounts, and use of methodology. SUBCHAPTER VII—AGENCY FOR HEALTHCARE RESEARCH AND QUALITY Editorial Notes PRIOR PROVISIONS A prior subchapter VII, related to the Agency for Health Care Policy and Research and consisted of sec- tions 299 to 299c–6, prior to the general amendment of this subchapter by Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1653. Another prior subchapter VII, related to education, research, training, and demonstrations in heart dis- ease, cancer, stroke, and related diseases and consisted of sections 299 to 299j, prior to repeal by Pub. L. 99–117, § 12(d), Oct. 7, 1985, 99 Stat. 495. PART A—ESTABLISHMENT AND GENERAL DUTIES § 299. Mission and duties (a) In general There is established within the Public Health Service an agency to be known as the Agency Page 1115 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 299 for Healthcare Research and Quality, which shall be headed by a director appointed by the Secretary. The Secretary shall carry out this subchapter acting through the Director. (b) Mission The purpose of the Agency is to enhance the quality, appropriateness, and effectiveness of health services, and access to such services, through the establishment of a broad base of sci- entific research and through the promotion of improvements in clinical and health system practices, including the prevention of diseases and other health conditions. The Agency shall promote health care quality improvement by conducting and supporting— (1) research that develops and presents sci- entific evidence regarding all aspects of health care, including— (A) the development and assessment of methods for enhancing patient participation in their own care and for facilitating shared patient-physician decision-making; (B) the outcomes, effectiveness, and cost- effectiveness of health care practices, in- cluding preventive measures and long-term care; (C) existing and innovative technologies; (D) the costs and utilization of, and access to health care; (E) the ways in which health care services are organized, delivered, and financed and the interaction and impact of these factors on the quality of patient care; (F) methods for measuring quality and strategies for improving quality; and (G) ways in which patients, consumers, purchasers, and practitioners acquire new information about best practices and health benefits, the determinants and impact of their use of this information; (2) the synthesis and dissemination of avail- able scientific evidence for use by patients, consumers, practitioners, providers, pur- chasers, policy makers, and educators; and (3) initiatives to advance private and public efforts to improve health care quality. (c) Requirements with respect to rural and inner-city areas and priority populations (1) Research, evaluations and demonstration projects In carrying out this subchapter, the Director shall conduct and support research and eval- uations, and support demonstration projects, with respect to— (A) the delivery of health care in inner- city areas, and in rural areas (including frontier areas); and (B) health care for priority populations, which shall include— (i) low-income groups; (ii) minority groups; (iii) women; (iv) children; (v) the elderly; and (vi) individuals with special health care needs, including individuals with disabil- ities and individuals who need chronic care or end-of-life health care. (2) Process to ensure appropriate research The Director shall establish a process to en- sure that the requirements of paragraph (1) are reflected in the overall portfolio of re- search conducted and supported by the Agen- cy. (3) Office of Priority Populations The Director shall establish an Office of Pri- ority Populations to assist in carrying out the requirements of paragraph (1). (July 1, 1944, ch. 373, title IX, § 901, as added Pub. L. 106–129, § 2(a), Dec. 6, 1999, 113 Stat. 1653.) Editorial Notes PRIOR PROVISIONS A prior section 299, act July 1, 1944, ch. 373, title IX, § 901, as added Pub. L. 101–239, title VI, § 6103(a), Dec. 19, 1989, 103 Stat. 2189; amended Pub. L. 102–410, § 2(a), Oct. 13, 1992, 106 Stat. 2094, established the Agency for Health Care Policy and Research, prior to the general amendment of this subchapter by Pub. L. 106–129. Another prior section 299, act July 1, 1944, ch. 373, title IX, § 900, as added Oct. 6, 1965, Pub. L. 89–239, § 2, 79 Stat. 926; amended Oct. 30, 1970, Pub. L. 91–515, title I, § 102, 84 Stat. 1297, set forth Congressional declaration of purpose of this subchapter to encourage and assist regional cooperative arrangements among medical schools, research institutions, and hospitals for re- search, training and medical data exchange, and to im- prove quality and capacity of health manpower and fa- cilities available throughout the nation, prior to repeal by Pub. L. 99–117, § 12(d), Oct. 7, 1985, 99 Stat. 495. A prior section 901 of act July 1, 1944, was classified to section 299a of this title prior to repeal by Pub. L. 99–117. Statutory Notes and Related Subsidiaries TRANSITIONAL AND SAVINGS PROVISIONS Pub. L. 101–239, title VI, § 6103(f), Dec. 19, 1989, 103 Stat. 2208, provided that personnel of the Department of Health and Human Services employed, and Depart- ment assets used in connection with Department func- tions, on Dec. 19, 1989, be transferred to the Adminis- trator for Health Care Policy and Research for appro- priate allocation, and provided that orders, rules, regu- lations, grants, contracts, certificates, licenses, privi- leges, and other determinations, actions, or official documents would continue in effect according to their terms unless changed pursuant to law. CONSTRUCTION Pub. L. 106–129, § 2(b), Dec. 6, 1999, 113 Stat. 1670, pro- vided that: ‘‘(1) IN GENERAL.—Section 901(a) of the Public Health Service Act [42 U.S.C. 299(a)] (as added by subsection (a) of this section) applies as a redesignation of the agency that carried out title IX of such Act [42 U.S.C. 299 et seq.] on the day before the date of the enactment of this Act [Dec. 6, 1999], and not as the termination of such agency and the establishment of a different agen- cy. The amendment made by subsection (a) of this sec- tion [enacting this subchapter] does not affect appoint- ments of the personnel of such agency who were em- ployed at the agency on the day before such date, in- cluding the appointments of members of advisory coun- cils or study sections of the agency who were serving on the day before such date of enactment. ‘‘(2) REFERENCES.—Any reference in law to the Agen- cy for Health Care Policy and Research is deemed to be a reference to the Agency for Healthcare Research and Quality, and any reference in law to the Administrator for Health Care Policy and Research is deemed to be a reference to the Director of the Agency for Healthcare Research and Quality.’’ IOM REPORTS ON BEST PRACTICES FOR DEVELOPING CLINICAL PROTOCOLS Pub. L. 110–275, title III, § 304(b), July 15, 2008, 122 Stat. 2595, as amended by Pub. L. 111–148, title X, § 10303(c), Mar. 23, 2010, 124 Stat. 938, provided that: Page 1116 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 299a ‘‘(1) STUDY.—Not later than 60 days after the date of the enactment of this Act [July 15, 2008], the Secretary of Health and Human Services shall enter into a con- tract with the Institute of Medicine of the National Academies (in this section [this note] referred to as the ‘Institute’) under which the Institute shall conduct a study on the best methods used in developing clinical practice guidelines in order to ensure that organiza- tions developing such guidelines have information on approaches that are objective, scientifically valid, and consistent. ‘‘(2) REPORT.—Not later than 18 months after the ef- fective date of the contract under paragraph (1), the In- stitute, as part of such contract, shall submit to the Secretary of Health and Human Services and the appro- priate committees of jurisdiction of Congress a report containing the results of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Institute determines appropriate. ‘‘(3) PARTICIPATION.—The contract under paragraph (1) shall require that stakeholders with expertise in making clinical recommendations participate on the panel responsible for conducting the study under para- graph (1) and preparing the report under paragraph (2). ‘‘(4) IDENTIFICATION.— ‘‘(A) IN GENERAL.—Following receipt of the report submitted under paragraph (2), and not less than every 3 years thereafter, the Secretary shall contract with the Institute to employ the results of the study performed under paragraph (1) and the best methods identified by the Institute for the purpose of identi- fying existing and new clinical practice guidelines that were developed using such best methods, includ- ing guidelines listed in the National Guideline Clear- inghouse. ‘‘(B) CONSULTATION.—In carrying out the identifica- tion process under subparagraph (A), the Secretary shall allow for consultation with professional soci- eties, voluntary health care organizations, and expert panels.’’ IOM STUDY ON DRUG SAFETY AND QUALITY Pub. L. 108–173, title I, § 107(c), Dec. 8, 2003, 117 Stat. 2170, provided that: ‘‘(1) IN GENERAL.—The Secretary [of Health and Human Services] shall enter into a contract with the Institutes of Medicine of the National Academies of Science (such Institutes referred to in this subsection as the ‘IOM’) to carry out a comprehensive study (in this subsection referred to as the ‘study’) of drug safety and quality issues in order to provide a blueprint for system-wide change. ‘‘(2) OBJECTIVES.— ‘‘(A) The study shall develop a full understanding of drug safety and quality issues through an evidence- based review of literature, case studies, and analysis. This review will consider the nature and causes of medication errors, their impact on patients, the dif- ferences in causation, impact, and prevention across multiple dimensions of health care delivery-including patient populations, care settings, clinicians, and in- stitutional cultures. ‘‘(B) The study shall attempt to develop credible es- timates of the incidence, severity, costs of medica- tion errors that can be useful in prioritizing re- sources for national quality improvement efforts and influencing national health care policy. ‘‘(C) The study shall evaluate alternative ap- proaches to reducing medication errors in terms of their efficacy, cost-effectiveness, appropriateness in different settings and circumstances, feasibility, in- stitutional barriers to implementation, associated risks, and the quality of evidence supporting the ap- proach. ‘‘(D) The study shall provide guidance to con- sumers, providers, payers, and other key stakeholders on high-priority strategies to achieve both short- term and long-term drug safety goals, to elucidate the goals and expected results of such initiatives and support the business case for them, and to identify critical success factors and key levers for achieving success. ‘‘(E) The study shall assess the opportunities and key impediments to broad nationwide implementa- tion of medication error reductions, and to provide guidance to policy-makers and government agencies (including the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the National Institutes of Health) in promoting a na- tional agenda for medication error reduction. ‘‘(F) The study shall develop an applied research agenda to evaluate the health and cost impacts of al- ternative interventions, and to assess collaborative public and private strategies for implementing the research agenda through AHRQ and other govern- ment agencies. ‘‘(3) CONDUCT OF STUDY.— ‘‘(A) EXPERT COMMITTEE.—In conducting the study, the IOM shall convene a committee of leading experts and key stakeholders in pharmaceutical management and drug safety, including clinicians, health services researchers, pharmacists, system administrators, payer representatives, and others. ‘‘(B) COMPLETION.—The study shall be completed within an 18-month period. ‘‘(4) REPORT.—A report on the study shall be sub- mitted to Congress upon the completion of the study. ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.—There are authorized to be appropriated to carry out this section such sums as may be necessary.’’ HEALTH CARE THAT WORKS FOR ALL AMERICANS: CITIZENS HEALTH CARE WORKING GROUP Pub. L. 108–173, title X, § 1014, Dec. 8, 2003, 117 Stat. 2441, directed the Secretary of Health and Human Serv- ices to establish the Citizens’ Health Care Working Group, composed of the Secretary and 14 other mem- bers, which was to hold hearings to examine various public and private health care coverage issues, make final recommendations to the President and Congress, and terminate 2 years after the members were chosen (Feb. 28, 2005) and appropriations were first made avail- able. Executive Documents EXECUTIVE ORDER NO. 13017 Ex. Ord. No. 13017, Sept. 5, 1996, 61 F.R. 47659, as amended by Ex. Ord. No. 13040, Mar. 25, 1997, 62 F.R. 14773; Ex. Ord. No. 13056, July 21, 1997, 62 F.R. 39415, which established the Advisory Commission on Con- sumer Protection and Quality in the Health Care Indus- try, was revoked by Ex. Ord. No. 13138, § 3(a), Sept. 30, 1999, 64 F.R. 53880, formerly set out as a note under sec- tion 1013 of Title 5, Government Organization and Em- ployees. § 299a. General authorities (a) In general In carrying out section 299(b) of this title, the Director shall conduct and support research, evaluations, and training, support demonstra- tion projects, research networks, and multidisci- plinary centers, provide technical assistance, and disseminate information on health care and on systems for the delivery of such care, includ- ing activities with respect to— (1) the quality, effectiveness, efficiency, ap- propriateness and value of health care serv- ices; (2) quality measurement and improvement; (3) the outcomes, cost, cost-effectiveness, and use of health care services and access to such services; (4) clinical practice, including primary care and practice-oriented research;