TITLE 42 - US CODE - SUBCHAPTER VII - AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

Part A - Establishment and General Duties

42 USC 299 - Mission and duties

(a) In general 
There is established within the Public Health Service an agency to be known as the Agency 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 scientific 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 scientific 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, including 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 available scientific evidence for use by patients, consumers, practitioners, providers, purchasers, 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 evaluations, 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 disabilities 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 ensure that the requirements of paragraph (1) are reflected in the overall portfolio of research conducted and supported by the Agency.
(3) Office of Priority Populations 
The Director shall establish an Office of Priority Populations to assist in carrying out the requirements of paragraph (1).

42 USC 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 demonstration projects, research networks, and multidisciplinary centers, provide technical assistance, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to
(1) the quality, effectiveness, efficiency, appropriateness and value of health care services;
(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;
(5) health care technologies, facilities, and equipment;
(6) health care costs, productivity, organization, and market forces;
(7) health promotion and disease prevention, including clinical preventive services;
(8) health statistics, surveys, database development, and epidemiology; and
(9) medical liability.
(b) Health services training grants 

(1) In general 
The Director may provide training grants in the field of health services research related to activities authorized under subsection (a) of this section, to include pre- and post-doctoral fellowships and training programs, young investigator awards, and other programs and activities as appropriate. In carrying out this subsection, the Director shall make use of funds made available under section 288 (d)(3) of this title as well as other appropriated funds.
(2) Requirements 
In developing priorities for the allocation of training funds under this subsection, the Director shall take into consideration shortages in the number of trained researchers who are addressing health care issues for the priority populations identified in section 299 (c)(1)(B) of this title and in addition, shall take into consideration indications of long-term commitment, amongst applicants for training funds, to addressing health care needs of the priority populations.
(c) Multidisciplinary centers 
The Director may provide financial assistance to assist in meeting the costs of planning and establishing new centers, and operating existing and new centers, for multidisciplinary health services research, demonstration projects, evaluations, training, and policy analysis with respect to the matters referred to in subsection (a) of this section.
(d) Relation to certain authorities regarding social security 
Activities authorized in this section shall be appropriately coordinated with experiments, demonstration projects, and other related activities authorized by the Social Security Act [42 U.S.C. 301 et seq.] and the Social Security Amendments of 1967. Activities under subsection (a)(2) of this section that affect the programs under titles XVIII, XIX and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.] shall be carried out consistent with section 1142 of such Act [42 U.S.C. 1320b–12].
(e) Disclaimer 
The Agency shall not mandate national standards of clinical practice or quality health care standards. Recommendations resulting from projects funded and published by the Agency shall include a corresponding disclaimer.
(f) Rule of construction 
Nothing in this section shall be construed to imply that the Agencys role is to mandate a national standard or specific approach to quality measurement and reporting. In research and quality improvement activities, the Agency shall consider a wide range of choices, providers, health care delivery systems, and individual preferences.

42 USC 299a1 - Research on health disparities

(a) In general 
The Director shall
(1) conduct and support research to identify populations for which there is a significant disparity in the quality, outcomes, cost, or use of health care services or access to and satisfaction with such services, as compared to the general population;
(2) conduct and support research on the causes of and barriers to reducing the health disparities identified in paragraph (1), taking into account such factors as socioeconomic status, attitudes toward health, the language spoken, the extent of formal education, the area or community in which the population resides, and other factors the Director determines to be appropriate;
(3) conduct and support research and support demonstration projects to identify, test, and evaluate strategies for reducing or eliminating health disparities, including development or identification of effective service delivery models, and disseminate effective strategies and models;
(4) develop measures and tools for the assessment and improvement of the outcomes, quality, and appropriateness of health care services provided to health disparity populations;
(5) in carrying out section 299a (c) of this title, provide support to increase the number of researchers who are members of health disparity populations, and the health services research capacity of institutions that train such researchers; and
(6) beginning with fiscal year 2003, annually submit to the Congress a report regarding prevailing disparities in health care delivery as it relates to racial factors and socioeconomic factors in priority populations.
(b) Research and demonstration projects 

(1) In general 
In carrying out subsection (a) of this section, the Director shall conduct and support research and support demonstrations to
(A) identify the clinical, cultural, socioeconomic, geographic, and organizational factors that contribute to health disparities, including minority health disparity populations, which research shall include behavioral research, such as examination of patterns of clinical decisionmaking, and research on access, outreach, and the availability of related support services (such as cultural and linguistic services);
(B) identify and evaluate clinical and organizational strategies to improve the quality, outcomes, and access to care for health disparity populations, including minority health disparity populations;
(C) test such strategies and widely disseminate those strategies for which there is scientific evidence of effectiveness; and
(D) determine the most effective approaches for disseminating research findings to health disparity populations, including minority populations.
(2) Use of certain strategies 
In carrying out this section, the Director shall implement research strategies and mechanisms that will enhance the involvement of individuals who are members of minority health disparity populations or other health disparity populations, health services researchers who are such individuals, institutions that train such individuals as researchers, members of minority health disparity populations or other health disparity populations for whom the Agency is attempting to improve the quality and outcomes of care, and representatives of appropriate tribal or other community-based organizations with respect to health disparity populations. Such research strategies and mechanisms may include the use of
(A) centers of excellence that can demonstrate, either individually or through consortia, a combination of multi-disciplinary expertise in outcomes or quality improvement research, linkages to relevant sites of care, and a demonstrated capacity to involve members and communities of health disparity populations, including minority health disparity populations, in the planning, conduct, dissemination, and translation of research;
(B) provider-based research networks, including health plans, facilities, or delivery system sites of care (especially primary care), that make extensive use of health care providers who are members of health disparity populations or who serve patients in such populations and have the capacity to evaluate and promote quality improvement;
(C) service delivery models (such as health centers under section 254b of this title and the Indian Health Service) to reduce health disparities; and
(D) innovative mechanisms or strategies that will facilitate the translation of past research investments into clinical practices that can reasonably be expected to benefit these populations.
(c) Quality measurement development 

(1) In general 
To ensure that health disparity populations, including minority health disparity populations, benefit from the progress made in the ability of individuals to measure the quality of health care delivery, the Director shall support the development of quality of health care measures that assess the experience of such populations with health care systems, such as measures that assess the access of such populations to health care, the cultural competence of the care provided, the quality of the care provided, the outcomes of care, or other aspects of health care practice that the Director determines to be important.
(2) Examination of certain practices 
The Director shall examine the practices of providers that have a record of reducing health disparities or have experience in providing culturally competent health services to minority health disparity populations or other health disparity populations. In examining such practices of providers funded under the authorities of this chapter, the Director shall consult with the heads of the relevant agencies of the Public Health Service.
(3) Report 
Not later than 36 months after November 22, 2000, the Secretary, acting through the Director, shall prepare and submit to the appropriate committees of Congress a report describing the state-of-the-art of quality measurement for minority and other health disparity populations that will identify critical unmet needs, the current activities of the Department to address those needs, and a description of related activities in the private sector.
(d) Definition 
For purposes of this section:
(1) The term health disparity population has the meaning given such term in section 287c–31 of this title, except that in addition to the meaning so given, the Director may determine that such term includes populations for which there is a significant disparity in the quality, outcomes, cost, or use of health care services or access to or satisfaction with such services as compared to the general population.
(2) The term minority, with respect to populations, refers to racial and ethnic minority groups as defined in section 300u–6 of this title.

Part B - Health Care Improvement Research

42 USC 299b - Health care outcome improvement research

(a) Evidence rating systems 
In collaboration with experts from the public and private sector, the Agency shall identify and disseminate methods or systems to assess health care research results, particularly methods or systems to rate the strength of the scientific evidence underlying health care practice, recommendations in the research literature, and technology assessments. The Agency shall make methods or systems for evidence rating widely available. Agency publications containing health care recommendations shall indicate the level of substantiating evidence using such methods or systems.
(b) Health care improvement research centers and provider-based research networks 

(1) In general 
In order to address the full continuum of care and outcomes research, to link research to practice improvement, and to speed the dissemination of research findings to community practice settings, the Agency shall employ research strategies and mechanisms that will link research directly with clinical practice in geographically diverse locations throughout the United States, including
(A) health care improvement research centers that combine demonstrated multidisciplinary expertise in outcomes or quality improvement research with linkages to relevant sites of care;
(B) provider-based research networks, including plan, facility, or delivery system sites of care (especially primary care), that can evaluate outcomes and evaluate and promote quality improvement; and
(C) other innovative mechanisms or strategies to link research with clinical practice.
(2) Requirements 
The Director is authorized to establish the requirements for entities applying for grants under this subsection.

42 USC 299b1 - Private-public partnerships to improve organization and delivery

(a) Support for efforts to develop information on quality 

(1) Scientific and technical support 
In its role as the principal agency for health care research and quality, the Agency may provide scientific and technical support for private and public efforts to improve health care quality, including the activities of accrediting organizations.
(2) Role of the Agency 
With respect to paragraph (1), the role of the Agency shall include
(A) the identification and assessment of methods for the evaluation of the health of
(i) enrollees in health plans by type of plan, provider, and provider arrangements; and
(ii) other populations, including those receiving long-term care services;
(B) the ongoing development, testing, and dissemination of quality measures, including measures of health and functional outcomes;
(C) the compilation and dissemination of health care quality measures developed in the private and public sector;
(D) assistance in the development of improved health care information systems;
(E) the development of survey tools for the purpose of measuring participant and beneficiary assessments of their health care; and
(F) identifying and disseminating information on mechanisms for the integration of information on quality into purchaser and consumer decision-making processes.
(b) Centers for education and research on therapeutics 

(1) In general 
The Secretary, acting through the Director and in consultation with the Commissioner of Food and Drugs, shall establish a program for the purpose of making one or more grants for the establishment and operation of one or more centers to carry out the activities specified in paragraph (2).
(2) Required activities 
The activities referred to in this paragraph are the following:
(A) The conduct of state-of-the-art research for the following purposes:
(i) To increase awareness of
(I) new uses of drugs, biological products, and devices;
(II) ways to improve the effective use of drugs, biological products, and devices; and
(III) risks of new uses and risks of combinations of drugs and biological products.
(ii) To provide objective clinical information to the following individuals and entities:
(I) Health care practitioners and other providers of health care goods or services.
(II) Pharmacists, pharmacy benefit managers and purchasers.
(III) Health maintenance organizations and other managed health care organizations.
(IV) Health care insurers and governmental agencies.
(V) Patients and consumers.
(iii) To improve the quality of health care while reducing the cost of health care through
(I) an increase in the appropriate use of drugs, biological products, or devices; and
(II) the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations.
(B) The conduct of research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices.
(C) Such other activities as the Secretary determines to be appropriate, except that a grant may not be expended to assist the Secretary in the review of new drugs, biological products, and devices.
(c) Reducing errors in medicine 
The Director shall, in accordance with part C of this subchapter, conduct and support research and build private-public partnerships to
(1) identify the causes of preventable health care errors and patient injury in health care delivery;
(2) develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety; and
(3) disseminate such effective strategies throughout the health care industry.

42 USC 299b2 - Information on quality and cost of care

(a) In general 
The Director shall
(1) conduct a survey to collect data on a nationally representative sample of the population on the cost, use and, for fiscal year 2001 and subsequent fiscal years, quality of health care, including the types of health care services Americans use, their access to health care services, frequency of use, how much is paid for the services used, the source of those payments, the types and costs of private health insurance, access, satisfaction, and quality of care for the general population including rural residents and also for populations identified in section 299 (c) of this title; and
(2) develop databases and tools that provide information to States on the quality, access, and use of health care services provided to their residents.
(b) Quality and outcomes information 

(1) In general 
Beginning in fiscal year 2001, the Director shall ensure that the survey conducted under subsection (a)(1) of this section will
(A) identify determinants of health outcomes and functional status, including the health care needs of populations identified in section 299 (c) of this title, provide data to study the relationships between health care quality, outcomes, access, use, and cost, measure changes over time, and monitor the overall national impact of Federal and State policy changes on health care;
(B) provide information on the quality of care and patient outcomes for frequently occurring clinical conditions for a nationally representative sample of the population including rural residents; and
(C) provide reliable national estimates for children and persons with special health care needs through the use of supplements or periodic expansions of the survey.

In expanding the Medical Expenditure Panel Survey, as in existence on December 6, 1999, in fiscal year 2001 to collect information on the quality of care, the Director shall take into account any outcomes measurements generally collected by private sector accreditation organizations.

(2) Annual report 
Beginning in fiscal year 2003, the Secretary, acting through the Director, shall submit to Congress an annual report on national trends in the quality of health care provided to the American people.

42 USC 299b3 - Information systems for health care improvement

(a) In general 
In order to foster a range of innovative approaches to the management and communication of health information, the Agency shall conduct and support research, evaluations, and initiatives to advance
(1) the use of information systems for the study of health care quality and outcomes, including the generation of both individual provider and plan-level comparative performance data;
(2) training for health care practitioners and researchers in the use of information systems;
(3) the creation of effective linkages between various sources of health information, including the development of information networks;
(4) the delivery and coordination of evidence-based health care services, including the use of real-time health care decision-support programs;
(5) the utility and comparability of health information data and medical vocabularies by addressing issues related to the content, structure, definitions and coding of such information and data in consultation with appropriate Federal, State and private entities;
(6) the use of computer-based health records in all settings for the development of personal health records for individual health assessment and maintenance, and for monitoring public health and outcomes of care within populations; and
(7) the protection of individually identifiable information in health services research and health care quality improvement.
(b) Demonstration 
The Agency shall support demonstrations into the use of new information tools aimed at improving shared decision-making between patients and their care-givers.
(c) Facilitating public access to information 
The Director shall work with appropriate public and private sector entities to facilitate public access to information regarding the quality of and consumer satisfaction with health care.

42 USC 299b4 - Research supporting primary care and access in underserved areas

(a) Preventive Services Task Force 

(1) Establishment and purpose 
The Director may periodically convene a Preventive Services Task Force to be composed of individuals with appropriate expertise. Such a task force shall review the scientific evidence related to the effectiveness, appropriateness, and cost-effectiveness of clinical preventive services for the purpose of developing recommendations for the health care community, and updating previous clinical preventive recommendations.
(2) Role of Agency 
The Agency shall provide ongoing administrative, research, and technical support for the operations of the Preventive Services Task Force, including coordinating and supporting the dissemination of the recommendations of the Task Force.
(3) Operation 
In carrying out its responsibilities under paragraph (1), the Task Force is not subject to the provisions of Appendix 2 of title 5.
(b) Primary care research 

(1) In general 
There is established within the Agency a Center for Primary Care Research (referred to in this subsection as the Center) that shall serve as the principal source of funding for primary care practice research in the Department of Health and Human Services. For purposes of this paragraph, primary care research focuses on the first contact when illness or health concerns arise, the diagnosis, treatment or referral to specialty care, preventive care, and the relationship between the clinician and the patient in the context of the family and community.
(2) Research 
In carrying out this section, the Center shall conduct and support research concerning
(A) the nature and characteristics of primary care practice;
(B) the management of commonly occurring clinical problems;
(C) the management of undifferentiated clinical problems; and
(D) the continuity and coordination of health services.

42 USC 299b4a - Studies on preventive interventions in primary care for older Americans

(a) Studies 
The Secretary of Health and Human Services, acting through the United States Preventive Services Task Force, shall conduct a series of studies designed to identify preventive interventions that can be delivered in the primary care setting and that are most valuable to older Americans.
(b) Mission statement 
The mission statement of the United States Preventive Services Task Force is amended to include the evaluation of services that are of particular relevance to older Americans.
(c) Report 
Not later than 1 year after December 21, 2000, and annually thereafter, the Secretary of Health and Human Services shall submit to Congress a report on the conclusions of the studies conducted under subsection (a) of this section, together with recommendations for such legislation and administrative actions as the Secretary considers appropriate.

42 USC 299b5 - Health care practice and technology innovation

(a) In general 
The Director shall promote innovation in evidence-based health care practices and technologies by
(1) conducting and supporting research on the development, diffusion, and use of health care technology;
(2) developing, evaluating, and disseminating methodologies for assessments of health care practices and technologies;
(3) conducting intramural and supporting extramural assessments of existing and new health care practices and technologies;
(4) promoting education and training and providing technical assistance in the use of health care practice and technology assessment methodologies and results; and
(5) working with the National Library of Medicine and the public and private sector to develop an electronic clearinghouse of currently available assessments and those in progress.
(b) Specification of process 

(1) In general 
Not later than December 31, 2000, the Director shall develop and publish a description of the methods used by the Agency and its contractors for health care practice and technology assessment.
(2) Consultations 
In carrying out this subsection, the Director shall cooperate and consult with the Assistant Secretary for Health, the Administrator of the Centers for Medicare & Medicaid Services, the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the heads of any other interested Federal department or agency, and shall seek input, where appropriate, from professional societies and other private and public entities.
(3) Methodology 
The Director shall, in developing the methods used under paragraph (1), consider
(A) safety, efficacy, and effectiveness;
(B) legal, social, and ethical implications;
(C) costs, benefits, and cost-effectiveness;
(D) comparisons to alternate health care practices and technologies; and
(E) requirements of Food and Drug Administration approval to avoid duplication.
(c) Specific assessments 

(1) In general 
The Director shall conduct or support specific assessments of health care technologies and practices.
(2) Requests for assessments 
The Director is authorized to conduct or support assessments, on a reimbursable basis, for the Centers for Medicare & Medicaid Services, the Department of Defense, the Department of Veterans Affairs, the Office of Personnel Management, and other public or private entities.
(3) Grants and contracts 
In addition to conducting assessments, the Director may make grants to, or enter into cooperative agreements or contracts with, entities described in paragraph (4) for the purpose of conducting assessments of experimental, emerging, existing, or potentially outmoded health care technologies, and for related activities.
(4) Eligible entities 
An entity described in this paragraph is an entity that is determined to be appropriate by the Director, including academic medical centers, research institutions and organizations, professional organizations, third party payers, governmental agencies, minority institutions of higher education (such as Historically Black Colleges and Universities, and Hispanic institutions), and consortia of appropriate research entities established for the purpose of conducting technology assessments.
(d) Medical examination of certain victims 

(1) In general 
The Director shall develop and disseminate a report on evidence-based clinical practices for
(A) the examination and treatment by health professionals of individuals who are victims of sexual assault (including child molestation) or attempted sexual assault; and
(B) the training of health professionals, in consultation with the Health Resources and Services Administration, on performing medical evidentiary examinations of individuals who are victims of child abuse or neglect, sexual assault, elder abuse, or domestic violence.
(2) Certain considerations 
In identifying the issues to be addressed by the report, the Director shall, to the extent practicable, take into consideration the expertise and experience of Federal and State law enforcement officials regarding the victims referred to in paragraph (1), and of other appropriate public and private entities (including medical societies, victim services organizations, sexual assault prevention organizations, and social services organizations).

42 USC 299b6 - Coordination of Federal Government quality improvement efforts

(a) Requirement 

(1) In general 
To avoid duplication and ensure that Federal resources are used efficiently and effectively, the Secretary, acting through the Director, shall coordinate all research, evaluations, and demonstrations related to health services research, quality measurement and quality improvement activities undertaken and supported by the Federal Government.
(2) Specific activities 
The Director, in collaboration with the appropriate Federal officials representing all concerned executive agencies and departments, shall develop and manage a process to
(A) improve interagency coordination, priority setting, and the use and sharing of research findings and data pertaining to Federal quality improvement programs, technology assessment, and health services research;
(B) strengthen the research information infrastructure, including databases, pertaining to Federal health services research and health care quality improvement initiatives;
(C) set specific goals for participating agencies and departments to further health services research and health care quality improvement; and
(D) strengthen the management of Federal health care quality improvement programs.
(b) Study by the Institute of Medicine 

(1) In general 
To provide Congress, the Department of Health and Human Services, and other relevant departments with an independent, external review of their quality oversight, quality improvement and quality research programs, the Secretary shall enter into a contract with the Institute of Medicine
(A) to describe and evaluate current quality improvement, quality research and quality monitoring processes through
(i) an overview of pertinent health services research activities and quality improvement efforts conducted by all Federal programs, with particular attention paid to those under titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.]; and
(ii) a summary of the partnerships that the Department of Health and Human Services has pursued with private accreditation, quality measurement and improvement organizations; and
(B) to identify options and make recommendations to improve the efficiency and effectiveness of quality improvement programs through
(i) the improved coordination of activities across the medicare, medicaid and child health insurance programs under titles XVIII, XIX and XXI of the Social Security Act and health services research programs;
(ii) the strengthening of patient choice and participation by incorporating state-of-the-art quality monitoring tools and making information on quality available; and
(iii) the enhancement of the most effective programs, consolidation as appropriate, and elimination of duplicative activities within various Federal agencies.
(2) Requirements 

(A) In general 
The Secretary shall enter into a contract with the Institute of Medicine for the preparation
(i) not later than 12 months after December 6, 1999, of a report providing an overview of the quality improvement programs of the Department of Health and Human Services for the medicare, medicaid, and CHIP programs under titles XVIII, XIX, and XXI of the Social Security Act; and
(ii) not later than 24 months after December 6, 1999, of a final report containing recommendations.
(B) Reports 
The Secretary shall submit the reports described in subparagraph (A) to the Committee on Finance and the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Ways and Means and the Committee on Commerce of the House of Representatives.

42 USC 299b7 - Research on outcomes of health care items and services

(a) Research, demonstrations, and evaluations 

(1) Improvement of effectiveness and efficiency 

(A) In general 
To improve the quality, effectiveness, and efficiency of health care delivered pursuant to the programs established under titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.], the Secretary[1] acting through the Director of the Agency for Healthcare Research and Quality (in this section referred to as the Director), shall conduct and support research to meet the priorities and requests for scientific evidence and information identified by such programs with respect to
(i) the outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs); and
(ii) strategies for improving the efficiency and effectiveness of such programs, including the ways in which such items and services are organized, managed, and delivered under such programs.
(B) Specification 
To respond to priorities and information requests in subparagraph (A), the Secretary may conduct or support, by grant, contract, or interagency agreement, research, demonstrations, evaluations, technology assessments, or other activities, including the provision of technical assistance, scientific expertise, or methodological assistance.
(2) Priorities 

(A) In general 
The Secretary shall establish a process to develop priorities that will guide the research, demonstrations, and evaluation activities undertaken pursuant to this section.
(B) Initial list 
Not later than 6 months after December 8, 2003, the Secretary shall establish an initial list of priorities for research related to health care items and services (including prescription drugs).
(C) Process 
In carrying out subparagraph (A), the Secretary
(i) shall ensure that there is broad and ongoing consultation with relevant stakeholders in identifying the highest priorities for research, demonstrations, and evaluations to support and improve the programs established under titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.];
(ii) may include health care items and services which impose a high cost on such programs, as well as those which may be underutilized or overutilized and which may significantly improve the prevention, treatment, or cure of diseases and conditions (including chronic conditions) which impose high direct or indirect costs on patients or society; and
(iii) shall ensure that the research and activities undertaken pursuant to this section are responsive to the specified priorities and are conducted in a timely manner.
(3) Evaluation and synthesis of scientific evidence 

(A) In general 
The Secretary shall
(i) evaluate and synthesize available scientific evidence related to health care items and services (including prescription drugs) identified as priorities in accordance with paragraph (2) with respect to the comparative clinical effectiveness, outcomes, appropriateness, and provision of such items and services (including prescription drugs);
(ii) identify issues for which existing scientific evidence is insufficient with respect to such health care items and services (including prescription drugs);
(iii) disseminate to prescription drug plans and MAPD plans under part D of title XVIII of the Social Security Act [42 U.S.C. 1395w–101 et seq.], other health plans, and the public the findings made under clauses (i) and (ii); and
(iv) work in voluntary collaboration with public and private sector entities to facilitate the development of new scientific knowledge regarding health care items and services (including prescription drugs).
(B) Initial research 
The Secretary shall complete the evaluation and synthesis of the initial research required by the priority list developed under paragraph (2)(B) not later than 18 months after the development of such list.
(C) Dissemination 

(i) In general To enhance patient safety and the quality of health care, the Secretary shall make available and disseminate in appropriate formats to prescription drugs plans under part D, and MAPD plans under part C, of title XVIII of the Social Security Act [42 U.S.C. 1395w–101 et seq., 1395w–21 et seq.], other health plans, and the public the evaluations and syntheses prepared pursuant to subparagraph (A) and the findings of research conducted pursuant to paragraph (1). In carrying out this clause the Secretary, in order to facilitate the availability of such evaluations and syntheses or findings at every decision point in the health care system, shall
(I) present such evaluations and syntheses or findings in a form that is easily understood by the individuals receiving health care items and services (including prescription drugs) under such plans and periodically assess that the requirements of this subclause have been met; and
(II) provide such evaluations and syntheses or findings and other relevant information through easily accessible and searchable electronic mechanisms, and in hard copy formats as appropriate.
(ii) Rule of construction Nothing in this section shall be construed as
(I) affecting the authority of the Secretary or the Commissioner of Food and Drugs under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] or the Public Health Service Act [42 U.S.C. 201 et seq.]; or
(II) conferring any authority referred to in subclause (I) to the Director.
(D) Accountability 
In carrying out this paragraph, the Secretary shall implement activities in a manner that
(i) makes publicly available all scientific evidence relied upon and the methodologies employed, provided such evidence and method are not protected from public disclosure by section 1905 of title 18 or other applicable law so that the results of the research, analyses, or syntheses can be evaluated or replicated; and
(ii) ensures that any information needs and unresolved issues identified in subparagraph (A)(ii) are taken into account in priority-setting for future research conducted by the Secretary.
(4) Confidentiality 

(A) In general 
In making use of administrative, clinical, and program data and information developed or collected with respect to the programs established under titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.], for purposes of carrying out the requirements of this section or the activities authorized under title IX of the Public Health Service Act (42 U.S.C. 299 et seq.), such data and information shall be protected in accordance with the confidentiality requirements of title IX of the Public Health Service Act.
(B) Rule of construction 
Nothing in this section shall be construed to require or permit the disclosure of data provided to the Secretary that is otherwise protected from disclosure under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], section 1905 of title 18, or other applicable law.
(5) Evaluations 
The Secretary shall conduct and support evaluations of the activities carried out under this section to determine the extent to which such activities have had an effect on outcomes and utilization of health care items and services.
(6) Improving information available to health care providers, patients, and policymakers 
Not later than 18 months after December 8, 2003, the Secretary shall identify options that could be undertaken in voluntary collaboration with private and public entities (as appropriate) for the
(A) provision of more timely information through the programs established under titles XVIII, XIX, and XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.], regarding the outcomes and quality of patient care, including clinical and patient-reported outcomes, especially with respect to interventions and conditions for which clinical trials would not be feasible or raise ethical concerns that are difficult to address;
(B) acceleration of the adoption of innovation and quality improvement under such programs; and
(C) development of management tools for the programs established under titles XIX and XXI of the Social Security Act [42 U.S.C. 1396 et seq., 1397aa et seq.], and with respect to the programs established under such titles, assess the feasibility of using administrative or claims data, to
(i) improve oversight by State officials;
(ii) support Federal and State initiatives to improve the quality, safety, and efficiency of services provided under such programs; and
(iii) provide a basis for estimating the fiscal and coverage impact of Federal or State program and policy changes.
(b) Recommendations 

(1) Disclaimer 
In carrying out this section, the Director shall
(A) not mandate national standards of clinical practice or quality health care standards; and
(B) include in any recommendations resulting from projects funded and published by the Director, a corresponding reference to the prohibition described in subparagraph (A).
(2) Requirement for implementation 
Research, evaluation, and communication activities performed pursuant to this section shall reflect the principle that clinicians and patients should have the best available evidence upon which to make choices in health care items and services, in providers, and in health care delivery systems, recognizing that patient subpopulations and patient and physician preferences may vary.
(3) Rule of construction 
Nothing in this section shall be construed to provide the Director with authority to mandate a national standard or require a specific approach to quality measurement and reporting.
(c) Research with respect to dissemination 
The Secretary, acting through the Director, may conduct or support research with respect to improving methods of disseminating information in accordance with subsection (a)(3)(C) of this section.
(d) Limitation on CMS 
The Administrator of the Centers for Medicare & Medicaid Services may not use data obtained in accordance with this section to withhold coverage of a prescription drug.
(e) Authorization of appropriations 
There is authorized to be appropriated to carry out this section, $50,000,000 for fiscal year 2004, and such sums as may be necessary for each fiscal year thereafter.
[1] So in original. Probably should be followed by a comma.

Part C - Patient Safety Improvement

42 USC 299b21 - Definitions

In this part:
(1) HIPAA confidentiality regulations 
The term HIPAA confidentiality regulations means regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104191; 110 Stat. 2033).
(2) Identifiable patient safety work product 
The term identifiable patient safety work product means patient safety work product that
(A) is presented in a form and manner that allows the identification of any provider that is a subject of the work product, or any providers that participate in activities that are a subject of the work product;
(B) constitutes individually identifiable health information as that term is defined in the HIPAA confidentiality regulations; or
(C) is presented in a form and manner that allows the identification of an individual who reported information in the manner specified in section 299b–22 (e) of this title.
(3) Nonidentifiable patient safety work product 
The term nonidentifiable patient safety work product means patient safety work product that is not identifiable patient safety work product (as defined in paragraph (2)).
(4) Patient safety organization 
The term patient safety organization means a private or public entity or component thereof that is listed by the Secretary pursuant to section 299b–24 (d) of this title.
(5) Patient safety activities 
The term patient safety activities means the following activities:
(A) Efforts to improve patient safety and the quality of health care delivery.
(B) The collection and analysis of patient safety work product.
(C) The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices.
(D) The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk.
(E) The maintenance of procedures to preserve confidentiality with respect to patient safety work product.
(F) The provision of appropriate security measures with respect to patient safety work product.
(G) The utilization of qualified staff.
(H) Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.
(6) Patient safety evaluation system 
The term patient safety evaluation system means the collection, management, or analysis of information for reporting to or by a patient safety organization.
(7) Patient safety work product 

(A) In general 
Except as provided in subparagraph (B), the term patient safety work product means any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements
(i) which
(I) are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization; or
(II) are developed by a patient safety organization for the conduct of patient safety activities;

and which could result in improved patient safety, health care quality, or health care outcomes; or

(ii) which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.
(B) Clarification 

(i) Information described in subparagraph (A) does not include a patients medical record, billing and discharge information, or any other original patient or provider record.
(ii) Information described in subparagraph (A) does not include information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system. Such separate information or a copy thereof reported to a patient safety organization shall not by reason of its reporting be considered patient safety work product.
(iii) Nothing in this part shall be construed to limit
(I) the discovery of or admissibility of information described in this subparagraph in a criminal, civil, or administrative proceeding;
(II) the reporting of information described in this subparagraph to a Federal, State, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes; or
(III) a providers recordkeeping obligation with respect to information described in this subparagraph under Federal, State, or local law.
(8) Provider 
The term provider means
(A) an individual or entity licensed or otherwise authorized under State law to provide health care services, including
(i) a hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, hospice program, renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care practitioners office, long term care facility, behavior health residential treatment facility, clinical laboratory, or health center; or
(ii) a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, pharmacist, or other individual health care practitioner; or
(B) any other individual or entity specified in regulations promulgated by the Secretary.

42 USC 299b22 - Privilege and confidentiality protections

(a) Privilege 
Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be privileged and shall not be
(1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(3) subject to disclosure pursuant to section 552 of title 5 (commonly known as the Freedom of Information Act) or any other similar Federal, State, or local law;
(4) admitted as evidence in any Federal, State, or local governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or
(5) admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.
(b) Confidentiality of patient safety work product 
Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be confidential and shall not be disclosed.
(c) Exceptions 
Except as provided in subsection (g)(3) of this section
(1) Exceptions from privilege and confidentiality 
Subsections (a) and (b) of this section shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
(A) Disclosure of relevant patient safety work product for use in a criminal proceeding, but only after a court makes an in camera determination that such patient safety work product contains evidence of a criminal act and that such patient safety work product is material to the proceeding and not reasonably available from any other source.
(B) Disclosure of patient safety work product to the extent required to carry out subsection (f)(4)(A) of this section.
(C) Disclosure of identifiable patient safety work product if authorized by each provider identified in such work product.
(2) Exceptions from confidentiality 
Subsection (b) of this section shall not apply to (and shall not be construed to prohibit) one or more of the following disclosures:
(A) Disclosure of patient safety work product to carry out patient safety activities.
(B) Disclosure of nonidentifiable patient safety work product.
(C) Disclosure of patient safety work product to grantees, contractors, or other entities carrying out research, evaluation, or demonstration projects authorized, funded, certified, or otherwise sanctioned by rule or other means by the Secretary, for the purpose of conducting research to the extent that disclosure of protected health information would be allowed for such purpose under the HIPAA confidentiality regulations.
(D) Disclosure by a provider to the Food and Drug Administration with respect to a product or activity regulated by the Food and Drug Administration.
(E) Voluntary disclosure of patient safety work product by a provider to an accrediting body that accredits that provider.
(F) Disclosures that the Secretary may determine, by rule or other means, are necessary for business operations and are consistent with the goals of this part.
(G) Disclosure of patient safety work product to law enforcement authorities relating to the commission of a crime (or to an event reasonably believed to be a crime) if the person making the disclosure believes, reasonably under the circumstances, that the patient safety work product that is disclosed is necessary for criminal law enforcement purposes.
(H) With respect to a person other than a patient safety organization, the disclosure of patient safety work product that does not include materials that
(i) assess the quality of care of an identifiable provider; or
(ii) describe or pertain to one or more actions or failures to act by an identifiable provider.
(3) Exception from privilege 
Subsection (a) of this section shall not apply to (and shall not be construed to prohibit) voluntary disclosure of nonidentifiable patient safety work product.
(d) Continued protection of information after disclosure 

(1) In general 
Patient safety work product that is disclosed under subsection (c) of this section shall continue to be privileged and confidential as provided for in subsections (a) and (b) of this section, and such disclosure shall not be treated as a waiver of privilege or confidentiality, and the privileged and confidential nature of such work product shall also apply to such work product in the possession or control of a person to whom such work product was disclosed.
(2) Exception 
Notwithstanding paragraph (1), and subject to paragraph (3)
(A) if patient safety work product is disclosed in a criminal proceeding, the confidentiality protections provided for in subsection (b) of this section shall no longer apply to the work product so disclosed; and
(B) if patient safety work product is disclosed as provided for in subsection (c)(2)(B) of this section (relating to disclosure of nonidentifiable patient safety work product), the privilege and confidentiality protections provided for in subsections (a) and (b) of this section shall no longer apply to such work product.
(3) Construction 
Paragraph (2) shall not be construed as terminating or limiting the privilege or confidentiality protections provided for in subsection (a) or (b) of this section with respect to patient safety work product other than the specific patient safety work product disclosed as provided for in subsection (c) of this section.
(4) Limitations on actions 

(A) Patient safety organizations 

(i) In general A patient safety organization shall not be compelled to disclose information collected or developed under this part whether or not such information is patient safety work product unless such information is identified, is not patient safety work product, and is not reasonably available from another source.
(ii) Nonapplication The limitation contained in clause (i) shall not apply in an action against a patient safety organization or with respect to disclosures pursuant to subsection (c)(1) of this section.
(B) Providers 
An accrediting body shall not take an accrediting action against a provider based on the good faith participation of the provider in the collection, development, reporting, or maintenance of patient safety work product in accordance with this part. An accrediting body may not require a provider to reveal its communications with any patient safety organization established in accordance with this part.
(e) Reporter protection 

(1) In general 
A provider may not take an adverse employment action, as described in paragraph (2), against an individual based upon the fact that the individual in good faith reported information
(A) to the provider with the intention of having the information reported to a patient safety organization; or
(B) directly to a patient safety organization.
(2) Adverse employment action 
For purposes of this subsection, an adverse employment action includes
(A) loss of employment, the failure to promote an individual, or the failure to provide any other employment-related benefit for which the individual would otherwise be eligible; or
(B) an adverse evaluation or decision made in relation to accreditation, certification, credentialing, or licensing of the individual.
(f) Enforcement 

(1) Civil monetary penalty 
Subject to paragraphs (2) and (3), a person who discloses identifiable patient safety work product in knowing or reckless violation of subsection (b) of this section shall be subject to a civil monetary penalty of not more than $10,000 for each act constituting such violation.
(2) Procedure 
The provisions of section 1320a–7a of this title, other than subsections (a) and (b) and the first sentence of subsection (c)(1), shall apply to civil money penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a of this title.
(3) Relation to HIPAA 
Penalties shall not be imposed both under this subsection and under the regulations issued pursuant to section 264(c)(1) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note ) for a single act or omission.
(4) Equitable relief 

(A) In general 
Without limiting remedies available to other parties, a civil action may be brought by any aggrieved individual to enjoin any act or practice that violates subsection (e) of this section and to obtain other appropriate equitable relief (including reinstatement, back pay, and restoration of benefits) to redress such violation.
(B) Against State employees 
An entity that is a State or an agency of a State government may not assert the privilege described in subsection (a) of this section unless before the time of the assertion, the entity or, in the case of and with respect to an agency, the State has consented to be subject to an action described in subparagraph (A), and that consent has remained in effect.
(g) Rule of construction 
Nothing in this section shall be construed
(1) to limit the application of other Federal, State, or local laws that provide greater privilege or confidentiality protections than the privilege and confidentiality protections provided for in this section;
(2) to limit, alter, or affect the requirements of Federal, State, or local law pertaining to information that is not privileged or confidential under this section;
(3) except as provided in subsection (i) of this section, to alter or affect the implementation of any provision of the HIPAA confidentiality regulations or section 1320d–5 of this title (or regulations promulgated under such section);
(4) to limit the authority of any provider, patient safety organization, or other entity to enter into a contract requiring greater confidentiality or delegating authority to make a disclosure or use in accordance with this section;
(5) as preempting or otherwise affecting any State law requiring a provider to report information that is not patient safety work product; or
(6) to limit, alter, or affect any requirement for reporting to the Food and Drug Administration information regarding the safety of a product or activity regulated by the Food and Drug Administration.
(h) Clarification 
Nothing in this part prohibits any person from conducting additional analysis for any purpose regardless of whether such additional analysis involves issues identical to or similar to those for which information was reported to or assessed by a patient safety organization or a patient safety evaluation system.
(i) Clarification of application of HIPAA confidentiality regulations to patient safety organizations 
For purposes of applying the HIPAA confidentiality regulations
(1) patient safety organizations shall be treated as business associates; and
(2) patient safety activities of such organizations in relation to a provider are deemed to be health care operations (as defined in such regulations) of the provider.
(j) Reports on strategies to improve patient safety 

(1) Draft report 
Not later than the date that is 18 months after any network of patient safety databases is operational, the Secretary, in consultation with the Director, shall prepare a draft report on effective strategies for reducing medical errors and increasing patient safety. The draft report shall include any measure determined appropriate by the Secretary to encourage the appropriate use of such strategies, including use in any federally funded programs. The Secretary shall make the draft report available for public comment and submit the draft report to the Institute of Medicine for review.
(2) Final report 
Not later than 1 year after the date described in paragraph (1), the Secretary shall submit a final report to the Congress.

42 USC 299b23 - Network of patient safety databases

(a) In general 
The Secretary shall facilitate the creation of, and maintain, a network of patient safety databases that provides an interactive evidence-based management resource for providers, patient safety organizations, and other entities. The network of databases shall have the capacity to accept, aggregate across the network, and analyze nonidentifiable patient safety work product voluntarily reported by patient safety organizations, providers, or other entities. The Secretary shall assess the feasibility of providing for a single point of access to the network for qualified researchers for information aggregated across the network and, if feasible, provide for implementation.
(b) Data standards 
The Secretary may determine common formats for the reporting to and among the network of patient safety databases maintained under subsection (a) of this section of nonidentifiable patient safety work product, including necessary work product elements, common and consistent definitions, and a standardized computer interface for the processing of such work product. To the extent practicable, such standards shall be consistent with the administrative simplification provisions of part C of title XI of the Social Security Act [42 U.S.C. 1320d et seq.].
(c) Use of information 
Information reported to and among the network of patient safety databases under subsection (a) of this section shall be used to analyze national and regional statistics, including trends and patterns of health care errors. The information resulting from such analyses shall be made available to the public and included in the annual quality reports prepared under section 299b–2 (b)(2) of this title.

42 USC 299b24 - Patient safety organization certification and listing

(a) Certification 

(1) Initial certification 
An entity that seeks to be a patient safety organization shall submit an initial certification to the Secretary that the entity
(A) has policies and procedures in place to perform each of the patient safety activities described in section 299b–21 (5) of this title; and
(B) upon being listed under subsection (d) of this section, will comply with the criteria described in subsection (b) of this section.
(2) Subsequent certifications 
An entity that is a patient safety organization shall submit every 3 years after the date of its initial listing under subsection (d) of this section a subsequent certification to the Secretary that the entity
(A) is performing each of the patient safety activities described in section 299b–21 (5) of this title; and
(B) is complying with the criteria described in subsection (b) of this section.
(b) Criteria 

(1) In general 
The following are criteria for the initial and subsequent certification of an entity as a patient safety organization:
(A) The mission and primary activity of the entity are to conduct activities that are to improve patient safety and the quality of health care delivery.
(B) The entity has appropriately qualified staff (whether directly or through contract), including licensed or certified medical professionals.
(C) The entity, within each 24-month period that begins after the date of the initial listing under subsection (d) of this section, has bona fide contracts, each of a reasonable period of time, with more than 1 provider for the purpose of receiving and reviewing patient safety work product.
(D) The entity is not, and is not a component of, a health insurance issuer (as defined in section 300gg–91 (b)(2) of this title).
(E) The entity shall fully disclose
(i) any financial, reporting, or contractual relationship between the entity and any provider that contracts with the entity; and
(ii) if applicable, the fact that the entity is not managed, controlled, and operated independently from any provider that contracts with the entity.
(F) To the extent practical and appropriate, the entity collects patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers.
(G) The utilization of patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk.
(2) Additional criteria for component organizations 
If an entity that seeks to be a patient safety organization is a component of another organization, the following are additional criteria for the initial and subsequent certification of the entity as a patient safety organization:
(A) The entity maintains patient safety work product separately from the rest of the organization, and establishes appropriate security measures to maintain the confidentiality of the patient safety work product.
(B) The entity does not make an unauthorized disclosure under this part of patient safety work product to the rest of the organization in breach of confidentiality.
(C) The mission of the entity does not create a conflict of interest with the rest of the organization.
(c) Review of certification 

(1) In general 

(A) Initial certification 
Upon the submission by an entity of an initial certification under subsection (a)(1) of this section, the Secretary shall determine if the certification meets the requirements of subparagraphs (A) and (B) of such subsection.
(B) Subsequent certification 
Upon the submission by an entity of a subsequent certification under subsection (a)(2) of this section, the Secretary shall review the certification with respect to requirements of subparagraphs (A) and (B) of such subsection.
(2) Notice of acceptance or non-acceptance 
If the Secretary determines that
(A) an entitys initial certification meets requirements referred to in paragraph (1)(A), the Secretary shall notify the entity of the acceptance of such certification; or
(B) an entitys initial certification does not meet such requirements, the Secretary shall notify the entity that such certification is not accepted and the reasons therefor.
(3) Disclosures regarding relationship to providers 
The Secretary shall consider any disclosures under subsection (b)(1)(E) of this section by an entity and shall make public findings on whether the entity can fairly and accurately perform the patient safety activities of a patient safety organization. The Secretary shall take those findings into consideration in determining whether to accept the entitys initial certification and any subsequent certification submitted under subsection (a) of this section and, based on those findings, may deny, condition, or revoke acceptance of the entitys certification.
(d) Listing 
The Secretary shall compile and maintain a listing of entities with respect to which there is an acceptance of a certification pursuant to subsection (c)(2)(A) of this section that has not been revoked under subsection (e) of this section or voluntarily relinquished.
(e) Revocation of acceptance of certification 

(1) In general 
If, after notice of deficiency, an opportunity for a hearing, and a reasonable opportunity for correction, the Secretary determines that a patient safety organization does not meet the certification requirements under subsection (a)(2) of this section, including subparagraphs (A) and (B) of such subsection, the Secretary shall revoke the Secretarys acceptance of the certification of such organization.
(2) Supplying confirmation of notification to providers 
Within 15 days of a revocation under paragraph (1), a patient safety organization shall submit to the Secretary a confirmation that the organization has taken all reasonable actions to notify each provider whose patient safety work product is collected or analyzed by the organization of such revocation.
(3) Publication of decision 
If the Secretary revokes the certification of an organization under paragraph (1), the Secretary shall
(A) remove the organization from the listing maintained under subsection (d) of this section; and
(B) publish notice of the revocation in the Federal Register.
(f) Status of data after removal from listing 

(1) New data 
With respect to the privilege and confidentiality protections described in section 299b–22 of this title, data submitted to an entity within 30 days after the entity is removed from the listing under subsection (e)(3)(A) of this section shall have the same status as data submitted while the entity was still listed.
(2) Protection to continue to apply 
If the privilege and confidentiality protections described in section 299b–22 of this title applied to patient safety work product while an entity was listed, or to data described in paragraph (1), such protections shall continue to apply to such work product or data after the entity is removed from the listing under subsection (e)(3)(A) of this section.
(g) Disposition of work product and data 
If the Secretary removes a patient safety organization from the listing as provided for in subsection (e)(3)(A) of this section, with respect to the patient safety work product or data described in subsection (f)(1) of this section that the patient safety organization received from another entity, such former patient safety organization shall
(1) with the approval of the other entity and a patient safety organization, transfer such work product or data to such patient safety organization;
(2) return such work product or data to the entity that submitted the work product or data; or
(3) if returning such work product or data to such entity is not practicable, destroy such work product or data.

42 USC 299b25 - Technical assistance

The Secretary, acting through the Director, may provide technical assistance to patient safety organizations, including convening annual meetings for patient safety organizations to discuss methodology, communication, data collection, or privacy concerns.

42 USC 299b26 - Severability

If any provision of this part is held to be unconstitutional, the remainder of this part shall not be affected.

Part D - General Provisions

42 USC 299c - Advisory Council for Healthcare Research and Quality

(a) Establishment 
There is established an advisory council to be known as the National Advisory Council for Healthcare Research and Quality.
(b) Duties 

(1) In general 
The Advisory Council shall advise the Secretary and the Director with respect to activities proposed or undertaken to carry out the mission of the Agency under section 299 (b) of this title.
(2) Certain recommendations 
Activities of the Advisory Council under paragraph (1) shall include making recommendations to the Director regarding
(A) priorities regarding health care research, especially studies related to quality, outcomes, cost and the utilization of, and access to, health care services;
(B) the field of health care research and related disciplines, especially issues related to training needs, and dissemination of information pertaining to health care quality; and
(C) the appropriate role of the Agency in each of these areas in light of private sector activity and identification of opportunities for public-private sector partnerships.
(c) Membership 

(1) In general 
The Advisory Council shall, in accordance with this subsection, be composed of appointed members and ex officio members. All members of the Advisory Council shall be voting members other than the individuals designated under paragraph (3)(B) as ex officio members.
(2) Appointed members 
The Secretary shall appoint to the Advisory Council 21 appropriately qualified individuals. At least 17 members of the Advisory Council shall be representatives of the public who are not officers or employees of the United States and at least 1 member who shall be a specialist in the rural aspects of 1 or more of the professions or fields described in subparagraphs (A) through (G). The Secretary shall ensure that the appointed members of the Council, as a group, are representative of professions and entities concerned with, or affected by, activities under this subchapter and under section 1320b–12 of this title. Of such members
(A) three shall be individuals distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care;
(B) three shall be individuals distinguished in the fields of health care quality research or health care improvement;
(C) three shall be individuals distinguished in the practice of medicine of which at least one shall be a primary care practitioner;
(D) three shall be individuals distinguished in the other health professions;
(E) three shall be individuals either representing the private health care sector, including health plans, providers, and purchasers or individuals distinguished as administrators of health care delivery systems;
(F) three shall be individuals distinguished in the fields of health care economics, information systems, law, ethics, business, or public policy; and
(G) three shall be individuals representing the interests of patients and consumers of health care.
(3) Ex officio members 
The Secretary shall designate as ex officio members of the Advisory Council
(A) the Assistant Secretary for Health, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Administrator of the Centers for Medicare & Medicaid Services, the Commissioner of the Food and Drug Administration, the Director of the Office of Personnel Management, the Assistant Secretary of Defense (Health Affairs), and the Under Secretary for Health of the Department of Veterans Affairs; and
(B) such other Federal officials as the Secretary may consider appropriate.
(d) Terms 

(1) In general 
Members of the Advisory Council appointed under subsection (c)(2) of this section shall serve for a term of 3 years.
(2) Staggered terms 
To ensure the staggered rotation of one-third of the members of the Advisory Council each year, the Secretary is authorized to appoint the initial members of the Advisory Council for terms of 1, 2, or 3 years.
(3) Service beyond term 
A member of the Council appointed under subsection (c)(2) of this section may continue to serve after the expiration of the term of the members until a successor is appointed.
(e) Vacancies 
If a member of the Advisory Council appointed under subsection (c)(2) of this section does not serve the full term applicable under subsection (d) of this section, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(f) Chair 
The Director shall, from among the members of the Advisory Council appointed under subsection (c)(2) of this section, designate an individual to serve as the chair of the Advisory Council.
(g) Meetings 
The Advisory Council shall meet not less than once during each discrete 4-month period and shall otherwise meet at the call of the Director or the chair.
(h) Compensation and reimbursement of expenses 

(1) Appointed members 
Members of the Advisory Council appointed under subsection (c)(2) of this section shall receive compensation for each day (including travel time) engaged in carrying out the duties of the Advisory Council unless declined by the member. Such compensation may not be in an amount in excess of the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315 of title 5 for each day during which such member is engaged in the performance of the duties of the Advisory Council.
(2) Ex officio members 
Officials designated under subsection (c)(3) of this section as ex officio members of the Advisory Council may not receive compensation for service on the Advisory Council in addition to the compensation otherwise received for duties carried out as officers of the United States.
(i) Staff 
The Director shall provide to the Advisory Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council.
(j) Duration 
Notwithstanding section 14(a) of the Federal Advisory Committee Act, the Advisory Council shall continue in existence until otherwise provided by law.

42 USC 299c1 - Peer review with respect to grants and contracts

(a) Requirement of review 

(1) In general 
Appropriate technical and scientific peer review shall be conducted with respect to each application for a grant, cooperative agreement, or contract under this subchapter.
(2) Reports to Director 
Each peer review group to which an application is submitted pursuant to paragraph (1) shall report its finding and recommendations respecting the application to the Director in such form and in such manner as the Director shall require.
(b) Approval as precondition of awards 
The Director may not approve an application described in subsection (a)(1) of this section unless the application is recommended for approval by a peer review group established under subsection (c) of this section.
(c) Establishment of peer review groups 

(1) In general 
The Director shall establish such technical and scientific peer review groups as may be necessary to carry out this section. Such groups shall be established without regard to the provisions of title 5 that govern appointments in the competitive service, and without regard to the provisions of chapter 51, and subchapter III of chapter 53, of such title that relate to classification and pay rates under the General Schedule.
(2) Membership 
The members of any peer review group established under this section shall be appointed from among individuals who by virtue of their training or experience are eminently qualified to carry out the duties of such peer review group. Officers and employees of the United States may not constitute more than 25 percent of the membership of any such group. Such officers and employees may not receive compensation for service on such groups in addition to the compensation otherwise received for these duties carried out as such officers and employees.
(3) Duration 
Notwithstanding section 14(a) of the Federal Advisory Committee Act, peer review groups established under this section may continue in existence until otherwise provided by law.
(4) Qualifications 
Members of any peer review group shall, at a minimum, meet the following requirements:
(A) Such members shall agree in writing to treat information received, pursuant to their work for the group, as confidential information, except that this subparagraph shall not apply to public records and public information.
(B) Such members shall agree in writing to recuse themselves from participation in the peer review of specific applications which present a potential personal conflict of interest or appearance of such conflict, including employment in a directly affected organization, stock ownership, or any financial or other arrangement that might introduce bias in the process of peer review.
(d) Authority for procedural adjustments in certain cases 
In the case of applications for financial assistance whose direct costs will not exceed $100,000, the Director may make appropriate adjustments in the procedures otherwise established by the Director for the conduct of peer review under this section. Such adjustments may be made for the purpose of encouraging the entry of individuals into the field of research, for the purpose of encouraging clinical practice-oriented or provider-based research, and for such other purposes as the Director may determine to be appropriate.
(e) Regulations 
The Director shall issue regulations for the conduct of peer review under this section.

42 USC 299c2 - Certain provisions with respect to development, collection, and dissemination of data

(a) Standards with respect to utility of data 

(1) In general 
To ensure the utility, accuracy, and sufficiency of data collected by or for the Agency for the purpose described in section 299 (b) of this title, the Director shall establish standard methods for developing and collecting such data, taking into consideration
(A) other Federal health data collection standards; and
(B) the differences between types of health care plans, delivery systems, health care providers, and provider arrangements.
(2) Relationship with other Department programs 
In any case where standards under paragraph (1) may affect the administration of other programs carried out by the Department of Health and Human Services, including the programs under title XVIII, XIX or XXI of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq., 1397aa et seq.], or may affect health information that is subject to a standard developed under part C of title XI of the Social Security Act [42 U.S.C. 1320d et seq.], they shall be in the form of recommendations to the Secretary for such program.
(b) Statistics and analyses 
The Director shall
(1) take appropriate action to ensure that statistics and analyses developed under this subchapter are of high quality, timely, and duly comprehensive, and that the statistics are specific, standardized, and adequately analyzed and indexed; and
(2) publish, make available, and disseminate such statistics and analyses on as wide a basis as is practicable.
(c) Authority regarding certain requests 
Upon request of a public or private entity, the Director may conduct or support research or analyses otherwise authorized by this subchapter pursuant to arrangements under which such entity will pay the cost of the services provided. Amounts received by the Director under such arrangements shall be available to the Director for obligation until expended.

42 USC 299c3 - Dissemination of information

(a) In general 
The Director shall
(1) without regard to section 501 of title 44, promptly publish, make available, and otherwise disseminate, in a form understandable and on as broad a basis as practicable so as to maximize its use, the results of research, demonstration projects, and evaluations conducted or supported under this subchapter;
(2) ensure that information disseminated by the Agency is science-based and objective and undertakes consultation as necessary to assess the appropriateness and usefulness of the presentation of information that is targeted to specific audiences;
(3) promptly make available to the public data developed in such research, demonstration projects, and evaluations;
(4) provide, in collaboration with the National Library of Medicine where appropriate, indexing, abstracting, translating, publishing, and other services leading to a more effective and timely dissemination of information on research, demonstration projects, and evaluations with respect to health care to public and private entities and individuals engaged in the improvement of health care delivery and the general public, and undertake programs to develop new or improved methods for making such information available; and
(5) as appropriate, provide technical assistance to State and local government and health agencies and conduct liaison activities to such agencies to foster dissemination.
(b) Prohibition against restrictions 
Except as provided in subsection (c) of this section, the Director may not restrict the publication or dissemination of data from, or the results of, projects conducted or supported under this subchapter.
(c) Limitation on use of certain information 
No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under this subchapter may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Director) to its use for such other purpose. Such information may not be published or released in other form if the person who supplied the information or who is described in it is identifiable unless such person has consented (as determined under regulations of the Director) to its publication or release in other form.
(d) Penalty 
Any person who violates subsection (c) of this section shall be subject to a civil monetary penalty of not more than $10,000 for each such violation involved. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1320a–7a of this title are imposed and collected.

42 USC 299c4 - Additional provisions with respect to grants and contracts

(a) Financial conflicts of interest 
With respect to projects for which awards of grants, cooperative agreements, or contracts are authorized to be made under this subchapter, the Director shall by regulation define
(1) the specific circumstances that constitute financial interests in such projects that will, or may be reasonably expected to, create a bias in favor of obtaining results in the projects that are consistent with such interests; and
(2) the actions that will be taken by the Director in response to any such interests identified by the Director.
(b) Requirement of application 
The Director may not, with respect to any program under this subchapter authorizing the provision of grants, cooperative agreements, or contracts, provide any such financial assistance unless an application for the assistance 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 Director determines to be necessary to carry out the program involved.
(c) Provision of supplies and services in lieu of funds 

(1) In general 
Upon the request of an entity receiving a grant, cooperative agreement, or contract under this subchapter, the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the entity in carrying out the project involved and, for such purpose, may detail to the entity any officer or employee of the Department of Health and Human Services.
(2) Corresponding reduction in funds 
With respect to a request described in paragraph (1), the Secretary shall reduce the amount of the financial assistance involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Director. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(d) Applicability of certain provisions with respect to contracts 
Contracts may be entered into under this part without regard to section 3324 (a) and (b) of title 31 and section 5 of title 41.

42 USC 299c5 - Certain administrative authorities

(a) Deputy director and other officers and employees 

(1) Deputy director 
The Director may appoint a deputy director for the Agency.
(2) Other officers and employees 
The Director may appoint and fix the compensation of such officers and employees as may be necessary to carry out this subchapter. Except as otherwise provided by law, such officers and employees shall be appointed in accordance with the civil service laws and their compensation fixed in accordance with title 5.
(b) Facilities 
The Secretary, in carrying out this subchapter
(1) may acquire, without regard to section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or portions of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed 10 years; and
(2) may acquire, construct, improve, repair, operate, and maintain laboratory, research, and other necessary facilities and equipment, and such other real or personal property (including patents) as the Secretary deems necessary.
(c) Provision of financial assistance 
The Director, in carrying out this subchapter, may make grants to public and nonprofit">nonprofit entities and individuals, and may enter into cooperative agreements or contracts with public and private entities and individuals.
(d) Utilization of certain personnel and resources 

(1) Department of Health and Human Services 
The Director, in carrying out this subchapter, may utilize personnel and equipment, facilities, and other physical resources of the Department of Health and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the physical resources of such Department, and provide technical assistance and advice.
(2) Other agencies 
The Director, in carrying out this subchapter, may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, or of any foreign government, with or without reimbursement of such agencies.
(e) Consultants 
The Secretary, in carrying out this subchapter, may secure, from time to time and for such periods as the Director deems advisable but in accordance with section 3109 of title 5, the assistance and advice of consultants from the United States or abroad.
(f) Experts 

(1) In general 
The Secretary may, in carrying out this subchapter, obtain the services of not more than 50 experts or consultants who have appropriate scientific or professional qualifications. Such experts or consultants shall be obtained in accordance with section 3109 of title 5, except that the limitation in such section on the duration of service shall not apply.
(2) Travel expenses 

(A) In general 
Experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed for their expenses associated with traveling to and from their assignment location in accordance with sections 5724, 5724a (a), 5724a (c), and 5726 (c) of title 5.
(B) Limitation 
Expenses specified in subparagraph (A) may not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless and until the expert agrees in writing to complete the entire period of assignment, or 1 year, whichever is shorter, unless separated or reassigned for reasons that are beyond the control of the expert or consultant and that are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for the expenses specified in subparagraph (A) is recoverable from the expert or consultant as a statutory obligation owed to the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph.
(g) Voluntary and uncompensated services 
The Director, in carrying out this subchapter, may accept voluntary and uncompensated services.

42 USC 299c6 - Funding

(a) Intent 
To ensure that the United States investment in biomedical research is rapidly translated into improvements in the quality of patient care, there must be a corresponding investment in research on the most effective clinical and organizational strategies for use of these findings in daily practice. The authorization levels in subsections (b) and (c) of this section provide for a proportionate increase in health care research as the United States investment in biomedical research increases.
(b) Authorization of appropriations 
For the purpose of carrying out this subchapter, there are authorized to be appropriated $250,000,000 for fiscal year 2000, and such sums as may be necessary for each of the fiscal years 2001 through 2005.
(c) Evaluations 
In addition to amounts available pursuant to subsection (b) of this section for carrying out this subchapter, there shall be made available for such purpose, from the amounts made available pursuant to section 238j of this title (relating to evaluations), an amount equal to 40 percent of the maximum amount authorized in such section 238j of this title to be made available for a fiscal year.
(d) Health disparities research 
For the purpose of carrying out the activities under section 299a–1 of this title, there are authorized to be appropriated $50,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 through 2005.
(e) Patient safety and quality improvement 
For the purpose of carrying out part C of this subchapter, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.

42 USC 299c7 - Definitions

In this subchapter:
(1) Advisory Council 
The term Advisory Council means the National Advisory Council on Healthcare Research and Quality established under section 299c of this title.
(2) Agency 
The term Agency means the Agency for Healthcare Research and Quality.
(3) Director 
The term Director means the Director of the Agency for Healthcare Research and Quality.