[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 580 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                 S. 580

To amend title IX of the Public Health Service Act to revise and extend 
             the Agency for Healthcare Policy and Research.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 10, 1999

  Mr. Frist (for himself, Mr. Jeffords, Mr. Kennedy, Mr. Nickles, Ms. 
Collins, Mr. Breaux, Mr. Inouye, Mr. Mack, Mr. Hagel, Mr. Santorum, Ms. 
 Mikulski, and Mr. Bingaman) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend title IX of the Public Health Service Act to revise and extend 
             the Agency for Healthcare Policy and Research.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Healthcare Research and Quality Act 
of 1999''.

SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) 
is amended to read as follows:

         ``TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

               ``PART A--ESTABLISHMENT AND GENERAL DUTIES

``SEC. 901. 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. In carrying out this subsection, the Secretary shall 
redesignate the Agency for Health Care Policy and Research as the 
Agency for Healthcare Research and Quality.
    ``(b) Mission.--The purpose of the Agency is to enhance the 
quality, appropriateness, and effectiveness of healthcare 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 
healthcare quality improvement by--
            ``(1) conducting and supporting research that develops and 
        presents scientific evidence regarding all aspects of 
        Healthcare, 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 healthcare practices, including 
                preventive measures and long-term care;
                    ``(C) existing and innovative technologies;
                    ``(D) the costs and utilization of, and access to 
                healthcare;
                    ``(E) the ways in which healthcare 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) synthesizing and disseminating available scientific 
        evidence for use by patients, consumers, practitioners, 
        providers, purchasers, policy makers, and educators; and
            ``(3) advancing private and public efforts to improve 
        healthcare quality.
    ``(c) Requirements With Respect to Rural Areas and Priority 
Populations.--In carrying out subsection (b), the Director shall 
undertake and support research, demonstration projects, and evaluations 
with respect to--
            ``(1) the delivery of health services in rural areas 
        (including frontier areas);
            ``(2) health services for low-income groups, and minority 
        groups;
            ``(3) the health of children;
            ``(4) the elderly; and
            ``(5) people with special healthcare needs, including 
        disabilities, chronic care and end-of-life healthcare.
    ``(d) Appointment of Director.--There shall be at the head of the 
Agency an official to be known as the Director for Healthcare Research 
and Quality. The Director shall be appointed by the Secretary. The 
Secretary, acting through the Director, shall carry out the authorities 
and duties established in this title.

``SEC. 902. GENERAL AUTHORITIES.

    ``(a) In General.--In carrying out section 901(b), the Director 
shall support demonstration projects, conduct and support research, 
evaluations, training, research networks, multi-disciplinary centers, 
technical assistance, and the dissemination of information, on 
healthcare, and on systems for the delivery of such care, including 
activities with respect to--
            ``(1) the quality, effectiveness, efficiency, 
        appropriateness and value of healthcare services;
            ``(2) quality measurement and improvement;
            ``(3) the outcomes, cost, cost-effectiveness, and use of 
        healthcare services and access to such services;
            ``(4) clinical practice, including primary care and 
        practice-oriented research;
            ``(5) healthcare technologies, facilities, and equipment;
            ``(6) healthcare 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), 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 487.
            ``(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 addressing 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).
    ``(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 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 shall be carried out consistent with section 1142 
of such Act.
    ``(e) Disclaimer.--The Agency shall not mandate national standards 
of clinical practice or quality healthcare 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 Agency's 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, healthcare delivery systems, and 
individual preferences.

               ``PART B--HEALTHCARE IMPROVEMENT RESEARCH

``SEC. 911. HEALTHCARE 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 that it uses to assess healthcare 
research results, particularly methods or systems that it uses to rate 
the strength of the scientific evidence behind healthcare practice, 
recommendations in the research literature, and technology assessments. 
The Agency shall make methods or systems for evidence rating widely 
available. Agency publications containing healthcare recommendations 
shall indicate the level of substantiating evidence using such methods 
or systems.
    ``(b) Healthcare 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) Healthcare 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 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.

``SEC. 912. 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 healthcare research and quality, the 
        Agency may provide scientific and technical support for private 
        and public efforts to improve healthcare 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 
                healthcare quality measures developed in the private 
                and public sector;
                    ``(D) assistance in the development of improved 
                healthcare information systems;
                    ``(E) the development of survey tools for the 
                purpose of measuring participant and beneficiary 
                assessments of their healthcare; 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 clinical 
                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) Healthcare practitioners and 
                                other providers of healthcare goods or 
                                services.
                                    ``(II) Pharmacists, pharmacy 
                                benefit managers and purchasers.
                                    ``(III) Health maintenance 
                                organizations and other managed 
                                healthcare organizations.
                                    ``(IV) Healthcare insurers and 
                                governmental agencies.
                                    ``(V) Patients and consumers.
                            ``(iii) To improve the quality of 
                        healthcare while reducing the cost of 
                        Healthcare 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.
    ``(c) Reducing Errors in Medicine.--The Director shall conduct and 
support research and build private-public partnerships to--
            ``(1) identify the causes of preventable healthcare errors 
        and patient injury in healthcare delivery;
            ``(2) develop, demonstrate, and evaluate strategies for 
        reducing errors and improving patient safety; and
            ``(3) promote the implementation of effective strategies 
        throughout the healthcare industry.

``SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.

    ``(a) In General.--In carrying out 902(a), 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 
        healthcare, including the types of healthcare services 
        Americans use, their access to healthcare 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 and also for populations identified in 
        section 901(c); and
            ``(2) develop databases and tools that provide information 
        to States on the quality, access, and use of healthcare 
        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) will--
                    ``(A) identify determinants of health outcomes and 
                functional status, the needs of special populations in 
                such variables as well as an understanding of changes 
                over time, relationships to healthcare access and use, 
                and monitor the overall national impact of Federal and 
                State policy changes on healthcare;
                    ``(B) provide information on the quality of care 
                and patient outcomes for frequently occurring clinical 
                conditions for a nationally representative sample of 
                the population; and
                    ``(C) provide reliable national estimates for 
                children and persons with special healthcare needs 
                through the use of supplements or periodic expansions 
                of the survey.
        In expanding the Medical Expenditure Panel Survey, as in 
        existence on the date of enactment of this title) 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 
        healthcare provided to the American people.

``SEC. 914. INFORMATION SYSTEMS FOR HEALTHCARE IMPROVEMENT.

    ``(a) In General.--In order to foster a range of innovative 
approaches to the management and communication of health information, 
the Agency shall support research, evaluations and initiatives to 
advance--
            ``(1) the use of information systems for the study of 
        healthcare quality, including the generation of both individual 
        provider and plan-level comparative performance data;
            ``(2) training for healthcare 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 
        healthcare services, including the use of real-time healthcare 
        decision-support programs;
            ``(5) the structure, content, definition, and coding of 
        health information data and medical vocabularies in 
        consultation with appropriate Federal entities and shall seek 
        input from appropriate private entities;
            ``(6) the use of computer-based health records in 
        outpatient and inpatient settings as a personal health record 
        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 healthcare 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.

``SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND ACCESS IN UNDERSERVED 
              AREAS.

    ``(a) Preventive Services Task Force.--
            ``(1) Purpose.--The Agency shall provide ongoing 
        administrative, research, and technical support for the 
        operation of the Preventive Services Task Force. The Agency 
        shall coordinate and support the dissemination of the 
        Preventive Services Task Force recommendations.
            ``(2) Operation.--The Preventive Services 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 
        healthcare community, and updating previous recommendations, 
        regarding their usefulness in daily clinical practice. In 
        carrying out its responsibilities under paragraph (1), the Task 
        Force shall not be subject to the provisions of Appendix 2 of 
        title 5, United States Code.
    ``(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.

``SEC. 916. CLINICAL PRACTICE AND TECHNOLOGY INNOVATION.

    ``(a) In General.--The Director shall promote innovation in 
evidence-based clinical practice and healthcare technologies by--
            ``(1) conducting and supporting research on the 
        development, diffusion, and use of healthcare technology;
            ``(2) developing, evaluating, and disseminating 
        methodologies for assessments of healthcare practices and 
        healthcare technologies;
            ``(3) conducting intramural and supporting extramural 
        assessments of existing and new healthcare practices and 
        technologies;
            ``(4) promoting education, training, and providing 
        technical assistance in the use of healthcare practice and 
        healthcare 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 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 Health Care 
        Financing Administration, 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 technologies and 
                practices; 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 healthcare technologies and practices.
            ``(2) Requests for assessments.--The Director is authorized 
        to conduct or support assessments, on a reimbursable basis, for 
        the Health Care Financing Administration, 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 
        healthcare 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, and consortia of 
        appropriate research entities established for the purpose of 
        conducting technology assessments.

``SEC. 917. 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 healthcare quality 
                improvement initiatives;
                    ``(C) set specific goals for participating agencies 
                and departments to further health services research and 
                healthcare quality improvement; and
                    ``(D) strengthen the management of Federal 
                healthcare 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; 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 the 
                        date of enactment of this title, 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 the 
                        date of enactment of this title, 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.

                      ``PART C--GENERAL PROVISIONS

``SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.

    ``(a) Establishment.--There is established an advisory council to 
be known as the 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 purpose of the Agency under 
        section 901(b).
            ``(2) Certain recommendations.--Activities of the Advisory 
        Council under paragraph (1) shall include making 
        recommendations to the Director regarding--
                    ``(A) priorities regarding healthcare research, 
                especially studies related to quality, outcomes, cost 
                and the utilization of, and access to, healthcare 
                services;
                    ``(B) the field of healthcare research and related 
                disciplines, especially issues related to training 
                needs, and dissemination of information pertaining to 
                healthcare 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. 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 title and under section 1142 of the Social Security Act. Of 
such members--
                    ``(A) 4 shall be individuals distinguished in the 
                conduct of research, demonstration projects, and 
                evaluations with respect to healthcare;
                    ``(B) 4 shall be individuals distinguished in the 
                practice of medicine of which at least 1 shall be a 
                primary care practitioner;
                    ``(C) 3 shall be individuals distinguished in the 
                other health professions;
                    ``(D) 4 shall be individuals either representing 
                the private healthcare sector, including health plans, 
                providers, and purchasers or individuals distinguished 
                as administrators of healthcare delivery systems;
                    ``(E) 4 shall be individuals distinguished in the 
                fields of healthcare quality improvement, economics, 
                information systems, law, ethics, business, or public 
                policy; and
                    ``(F) 2 shall be individuals representing the 
                interests of patients and consumers of healthcare.
            ``(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 Health Care 
                Financing Administration, 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.--Members of the Advisory Council appointed under 
subsection (c)(2) shall serve for a term of 3 years. A member of the 
Council appointed under such subsection 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) does not serve the full term applicable under 
subsection (d), 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), 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) 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 maximum rate of basic pay payable for GS-18 of the General 
        Schedule.
            ``(2) Ex officio members.--Officials designated under 
        subsection (c)(3) 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.

``SEC. 922. 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 
        title.
            ``(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) unless the 
application is recommended for approval by a peer review group 
established under subsection (c).
    ``(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, United States 
        Code, 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.

``SEC. 923. 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 901(b), 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 healthcare 
                plans, delivery systems, healthcare 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, or may 
        affect health information that is subject to a standard 
        developed under part C of title XI of the Social Security Act, 
        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 title 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 title 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.

``SEC. 924. DISSEMINATION OF INFORMATION.

    ``(a) In General.--The Director shall--
            ``(1) without regard to section 501 of title 44, United 
        States Code, 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 title;
            ``(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 
        healthcare to public and private entities and individuals 
        engaged in the improvement of healthcare 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), the Director may not restrict the publication or 
dissemination of data from, or the results of, projects conducted or 
supported under this title.
    ``(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 title 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) 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 1128A of the Social Security Act are imposed and collected.

``SEC. 925. 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 title, 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 title 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 title, 
        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 sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 
529; 41 U.S.C. 5).

``SEC. 926. 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 title. 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, United States 
        Code.
    ``(b) Facilities.--The Secretary, in carrying out this title--
            ``(1) may acquire, without regard to the Act of March 3, 
        1877 (40 U.S.C. 34), by lease or otherwise through the Director 
        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 title, may make grants to public and 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 title, 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 
        title, 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 title, may 
secure, from time to time and for such periods as the Director deems 
advisable but in accordance with section 3109 of title 5, United States 
Code, the assistance and advice of consultants from the United States 
or abroad.
    ``(f) Experts.--
            ``(1) In general.--The Secretary may, in carrying out this 
        title, 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, United States Code, 
        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, United States Code.
                    ``(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 title, may accept voluntary and uncompensated 
services.

``SEC. 927. FUNDING.

    ``(a) Intent.--To ensure that the United States's 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) provide for a proportionate increase in 
healthcare research as the United State's investment in biomedical 
research increases.
    ``(b) Authorization of Appropriations.--For the purpose of carrying 
out this title, 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 2006.
    ``(c) Evaluations.--In addition to amounts available pursuant to 
subsection (b) for carrying out this title, there shall be made 
available for such purpose, from the amounts made available pursuant to 
section 241 (relating to evaluations), an amount equal to 40 percent of 
the maximum amount authorized in such section 241 to be made available 
for a fiscal year.

``SEC. 928. DEFINITIONS.

    ``In this title:
            ``(1) Advisory council.--The term `Advisory Council' means 
        the Advisory Council on Healthcare Research and Quality 
        established under section 921.
            ``(2) Agency.--The term `Agency' means the Agency for 
        Healthcare Research and Quality.
            ``(3) Director.--The term `Director' means the Director for 
        the Agency for Healthcare Research and Quality.''.

SEC. 3. REFERENCES.

    Effective upon the date of enactment of this Act, any reference in 
law to the ``Agency for Health Care Policy and Research'' shall be 
deemed to be a reference to the ``Agency for Healthcare Research and 
Quality''.
                                 <all>