[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 2208 Introduced in Senate (IS)]







105th CONGRESS
  2d Session
                                S. 2208

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

                             June 23, 1998

   Mr. Frist introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 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 Quality Enhancement Act 
of 1998''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Amendment to the Public Health Service Act.
               ``TITLE IX--AGENCY FOR HEALTHCARE QUALITY

               ``Part A--Establishment and General Duties

        ``Sec. 901. Mission and duties.
        ``Sec. 902. General authorities.
               ``Part B--Healthcare Improvement Research

        ``Sec. 911. Healthcare outcome improvement research.
        ``Sec. 912. Private-public partnerships to improve organization 
                            and delivery.
        ``Sec. 913. Information on quality and cost of care.
        ``Sec. 914. Information systems for healthcare improvement.
        ``Sec. 915. Research supporting primary care and access in 
                            underserved areas.
        ``Sec. 916. Clinical practice and technology innovation.
        ``Sec. 917. Coordination of Federal Government quality 
                            improvement efforts.
                      ``Part C--General Provisions

        ``Sec. 921. Advisory Council for Healthcare Quality.
        ``Sec. 922. Foundation for Healthcare Research.
        ``Sec. 923. Peer review with respect to grants and contracts.
        ``Sec. 924. Certain provisions with respect to development, 
                            collection, and dissemination of data.
        ``Sec. 925. Dissemination of information.
        ``Sec. 926. Additional provisions with respect to grants and 
                            contracts.
        ``Sec. 927. Certain administrative authorities.
        ``Sec. 928. Funding.
        ``Sec. 929. Definitions.
Sec. 4. References.

SEC. 3. 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 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 Quality. In 
carrying out this subsection, the Secretary shall redesignate the 
Agency for Healthcare Policy and Research as the Agency for Healthcare 
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 practice, 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 
                the purposes of 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 primary 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, and 
                practitioners acquire new information about best 
                practices and health benefits, and the determinants 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 
        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 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, 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.--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 478.
    ``(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 may include, and 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 and XIX of 
the Social Security Act shall be carried out consistent with section 
1142 of such Act.
    ``(e) Disclaimer.--Nothing in this title shall be construed to 
imply that the Agency's role is to 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 used to assess healthcare research 
results, particularly--
            ``(1) to rate the strength of the scientific evidence 
        behind healthcare practice and technology recommendations in 
        the research literature; and
            ``(2) to assess the quality and currency of health related 
        information available on the Internet and other electronic 
        media.
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) Practice-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.
            ``(2) Requirements.--The Director is authorized to 
        establish the requirements for entities applying for grants 
        under this subsection.
    ``(c) Expansion of the Health Services Research Workforce.--
            ``(1) Grants.--The Agency shall, through the awarding of 
        grants, support eligible entities at geographically diverse 
        locations throughout the United States to enable such entities 
        to carry out research training programs that are dedicated to 
        health services research training at the doctoral, post-
        doctoral, and junior faculty levels.
            ``(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.

``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 quality research, the Agency 
        shall provide scientific and technical support for private and 
        public efforts to improve healthcare quality, including 
        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 enrollees in health 
                plans by type of plan, provider, and provider 
                arrangements;
                    ``(B) the ongoing development, testing, and 
                dissemination of quality measures, including measures 
                of health and functional outcomes, that take into 
                account appropriate variations in individual 
                preferences;
                    ``(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) the integration of information on quality 
                into purchaser and consumer decision-making processes.
    ``(b) Demonstration Program Regarding 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 demonstration 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) 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) 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.
            ``(3) Application for grant.--A grant under paragraph (1) 
        may be made only if an application for the grant is submitted 
        to the Secretary and the application is in such form, is made 
        in such manner, and contains such agreements, assurances, and 
        information as the Secretary determines to be necessary to 
        carry out this section.
            ``(4) Peer review.--A grant under paragraph (1) may be made 
        only if the application for the grant has undergone appropriate 
        technical and scientific peer review.
    ``(c) Research on Healthcare Benefits.--
            ``(1) Purpose.--The Director is authorized to conduct and 
        support research to evaluate the impact of changes in 
        healthcare benefits.
            ``(2) Considerations.--In carrying out paragraph (1), the 
        Director shall build partnerships with appropriate public and 
        private sector entities to review available scientific evidence 
        and undertake such evaluations. As appropriate and to the 
        extent that data are available, the evaluation shall consider--
                    ``(A) safety and effectiveness, including health 
                and functional outcomes of patients;
                    ``(B) costs, benefits, and cost-effectiveness; and
                    ``(C) comparisons with alternative clinical 
                approaches.
    ``(d) 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 systems;
            ``(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) collect data from a nationally representative sample 
        of the population on the cost and use 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 
        children, uninsured persons, poor and near-poor individuals, 
        and persons with special healthcare needs, including end-of-
        life healthcare;
            ``(2) develop databases and tools that enable States to 
        track the quality, access, and use of healthcare services 
        provided to their residents; and
            ``(3) enter into agreements with public or private entities 
        to use, link, or acquire databases for research authorized 
        under this title.
    ``(b) Quality and Outcomes Information.--
            ``(1) In general.--To enhance the understanding of the 
        quality of care, the determinants of health outcomes and 
        functional status, the needs of special populations as well as 
        an understanding of these changes over time, their relationship 
        to healthcare access and use, and to monitor the overall 
        national impact of Federal and State policy changes on 
        healthcare, the Director, beginning in fiscal year 2000, shall 
        ensure that the survey conducted under subsection (a)(1) will--
                    ``(A) provide information on the quality of care 
                and patient outcomes for frequently occurring clinical 
                conditions for a nationally representative sample of 
                the population; and
                    ``(B) provide reliable national estimates for 
                children and persons with special healthcare needs 
through the use of supplements or periodic expansions of the survey.
            ``(2) Annual report.--Beginning in fiscal year 2002, 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.

    ``In order to foster a range of innovative approaches to the 
management and communication of health information, the Agency shall 
support research to evaluate 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 measures;
            ``(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, using real-time decision-support programs;
            ``(5) the structure, content, definition, and coding of 
        health information data and medical vocabularies and shall 
        consult with other Federal entities;
            ``(6) the evaluation and 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.

``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, 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 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 on--
                    ``(A) the nature and characteristics of primary 
                care practice;
                    ``(B) producing evidence for the management of 
                commonly occurring clinical problems;
                    ``(C) the management of undifferentiated clinical 
                problems; and
                    ``(D) the continuity and coordination of health 
                services.
            ``(3) 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. 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 healthcare practice and technology 
        assessment;
            ``(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 June 1, 1999, 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 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, professional societies, and other private and public 
        entities.
            ``(3) Methodology.--The methods employed in practice and 
        technology assessments under paragraph (1) shall consider--
                    ``(A) safety, efficacy, and effectiveness;
                    ``(B) legal, social, and ethical implications;
                    ``(C) costs, benefits, and cost-effectiveness;
                    ``(D) comparisons to alternative 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 and support 
        specific assessments of healthcare technologies and practices.
            ``(2) Grants and contracts.--The Director may make grants 
        to, or enter into cooperative agreements or contracts with, 
        entities described in paragraph (3) for the establishment of 
        collaborative arrangements for the purpose of conducting 
        assessments of experimental, emerging, existing, or potentially 
        outmoded healthcare technologies, and for related activities.
            ``(3) 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, professional organizations, third party payers, 
        other 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.--The Secretary, acting through the 
        Director, shall coordinate all research, evaluations, and 
        demonstrations related to health services research and quality 
        measurement and 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 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 the Department of Health and 
        Human Services with independent, expert advice in redesigning 
        its quality oversight functions, and pertinent research 
        programs, the Secretary shall enter into a contract with the 
        Institute of Medicine--
                    ``(A) to describe and evaluate current quality 
                improvement research and monitoring processes through--
                            ``(i) an overview of pertinent health 
                        services research activities and quality 
                        improvement efforts with particular attention 
                        paid to those performed by the peer review 
                        organizations;
                            ``(ii) an analysis of the various 
                        partnership activities that the Department of 
                        Health and Human Services has pursued with 
private sector accreditation and other quality measurement 
organizations;
                            ``(iii) the exploration of programmatic 
                        areas where partnership activities could be 
                        pursued to improve quality oversight of the 
                        medicare and medicaid programs under titles 
                        XVIII and XIX of the Social Security Act; and
                            ``(iv) an identification of opportunities 
                        for enhancing health system efficiency through 
                        simplification and reduction in redundancy of 
                        public and private sector quality improvement 
                        efforts; and
                    ``(B) to identify options and make recommendations 
                to improve the efficiency and effectiveness of such 
                quality improvement programs and to optimize public/
                private sector accreditation bodies through--
                            ``(i) the improved coordination of 
                        activities across the medicare and medicaid 
                        programs under titles XVIII and XIX of the 
                        Social Security Act and various health services 
                        research programs;
                            ``(ii) greater consistency and 
                        standardization of oversight activities across 
                        traditional fee-for-service and managed care 
                        components of these programs;
                            ``(iii) the strengthening of patient choice 
                        and participation by incorporating state-of-
                        the-art quality monitoring tools and making 
                        information on quality available; and
                            ``(iv) 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 for a 
                        comprehensive system and public-private 
                        partnerships for healthcare quality 
                        improvement.
                    ``(B) Reports.--The Secretary shall submit the 
                reports described in subparagraph (A) to the Committee 
                on Finance and the Committee on Labor and Human 
                Resources 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 QUALITY.

    ``(a) Establishment.--There is established an advisory council to 
be known as the Advisory Council for Healthcare Quality.
    ``(b) Duties.--
            ``(1) In general.--The Advisory Council shall advise the 
        Secretary and the Director with respect to activities 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 on 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) who shall be ex officio 
        members of the Advisory Council.
            ``(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 
                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 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 Chief Medical Officer 
                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. FOUNDATION FOR HEALTHCARE RESEARCH.

    ``(a) In General.--The Secretary shall, acting through the Director 
of the Agency for Healthcare Quality, establish a nonprofit corporation 
to be known as the Foundation for Healthcare Research (hereafter in 
this section referred to as the `Foundation'). The Foundation shall not 
be an agency or instrumentality of the United States Government.
    ``(b) Purpose of Foundation.--The purpose of the Foundation shall 
be to--
            ``(1) support the Agency for Healthcare Quality in its 
        mission;
            ``(2) foster public-private partnerships to support the 
        programs and activities of the Agency;
            ``(3) advance collaboration with healthcare researchers 
        from universities, industry, and nonprofit organizations; and
            ``(4) develop linkages with users of healthcare and quality 
        research, including patients, consumers, practitioners and 
other healthcare providers, health plans and insurers, large private or 
public sector purchasers of healthcare, healthcare policy makers, and 
healthcare educators.
    ``(c) Certain Activities of Foundation.--In carrying out subsection 
(b), the Foundation may solicit and accept gifts, grants, and other 
donations, establish accounts, and invest and expend funds in support 
of a broad range of research, training, dissemination, and other 
activities with respect to the purpose described in such subsection. In 
addition, the Foundation is authorized to support the following:
            ``(1) A program to provide and administer endowed positions 
        that are associated with the research program of the Agency for 
        Healthcare Quality. Such endowments may be expended for the 
        compensation of individuals holding the positions, for staff, 
        equipment, quarters, travel, and other expenditures that are 
        appropriate in supporting the endowed positions.
            ``(2) A program to provide and administer fellowships and 
        grants to research personnel in order to work and study in 
        association with the Agency for Healthcare Quality. Such 
        fellowships and grants may include stipends, travel, health 
        insurance benefits, and other appropriate expenses. The 
        recipients of fellowships shall be selected by the donors and 
        the Foundation upon the recommendation of the Agency for 
        Healthcare Quality, and shall be subject to the agreement of 
        the Director of the Agency for Healthcare Quality and the 
        Executive Director of the Foundation.
    ``(d) General Structure of Foundation; Nonprofit Status.--
            ``(1) Board of directors.--The Foundation shall have a 
        Board of Directors (in this section referred to as the Board), 
        which shall be established and conducted in accordance with 
        subsection (e). The Board shall establish the general policies 
        of the Foundation for carrying out subsection (b), including 
        the establishment of the bylaws of the Foundation.
            ``(2) Executive director.--The Foundation shall have an 
        executive director (in this section referred to as the 
        `Director'), who shall be appointed by the Board, who shall 
        serve at the pleasure of the Board, and for whom the Board 
        shall establish the rate of compensation. Subject to compliance 
        with the policies and bylaws established by the Board pursuant 
        to paragraph (1), the Director shall be responsible for the 
        daily operations of the Foundation in carrying out subsection 
        (b).
            ``(3) Nonprofit status.--In carrying out subsection (b), 
        the Board shall establish such policies and bylaws under 
        paragraph (1), and the Director shall carry out such activities 
        under paragraph (2), as may be necessary to ensure that the 
        Foundation maintains status as an organization that--
                    ``(A) is described in subsection (c)(3) of section 
                501 of the Internal Revenue Code of 1986; and
                    ``(B) is, under subsection (a) of such section, 
                exempt from taxation.
    ``(e) Board of Directors.--
            ``(1) Certain bylaws.--
                    ``(A) In general.--The Board shall ensure that 
                bylaws established under subsection (a)(1) include 
                bylaws for the following:
                            ``(i) Policies for the selection of the 
                        officers, employees, agents, and contractors of 
                        the Foundation.
                            ``(ii) Policies, including ethical 
                        standards, for the acceptance and disposition 
                        of donations to the Foundation and for the 
                        disposition of the assets of the Foundation.
                            ``(iii) Policies for the conduct of the 
                        general operations of the Foundation.
                            ``(iv) Policies for writing, editing, 
                        printing, and publishing of books and other 
                        materials, and the acquisition of patents and 
                        licenses for devices and procedures developed 
                        by the Foundation.
                    ``(B) Requirements.--The Board shall ensure that 
                the bylaws established under subsection (d)(1) (and 
                activities carried out under such bylaws) do not--
                            ``(i) reflect unfavorably upon the ability 
                        of the Foundation, or the Agency for Healthcare 
                        Quality, to carry out its responsibilities or 
                        official duties in a fair and objective manner; 
                        or
                            ``(ii) compromise, or appear to compromise, 
                        the integrity of any governmental program or 
                        any officer or employee involved in such 
                        program.
            ``(2) Composition.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Board shall be composed of 7 individuals, appointed in 
                accordance with paragraph (4), who collectively possess 
                education or experience appropriate for representing 
the constituencies described in subsection (b). Each such individual 
shall be a voting member of the Board.
                    ``(B) Additional members.--The Board may, through 
                amendments to the bylaws of the Foundation, provide 
                that the number of members of the Board shall be a 
                greater number than the number specified in 
                subparagraph (A).
            ``(3) Chair.--The Board shall, from among the members of 
        the Board, designate an individual to serve as the chair of the 
        Board (in this subsection referred to as the `Chair').
            ``(4) Appointments, vacancies, and terms.--The following 
        shall apply to the Board:
                    ``(A) Any vacancy in the membership of the Board 
                shall be filled by appointment by the Board, after 
                consideration of suggestions made by the Chair and the 
                Director regarding the appointments. Any such vacancy 
                shall be filled not later than the expiration of the 
                180-day period beginning on the date on which the 
                vacancy occurs.
                    ``(B) The term of office of each member of the 
                Board appointed under subparagraph (A) shall be 5 
                years. A member of the Board may continue to serve 
                after the expiration of the term of the member until 
                the expiration of the 180-day period beginning on the 
                date on which the term of the member expires.
                    ``(C) A vacancy in the membership of the Board 
                shall not affect the power of the Board to carry out 
                the duties of the Board. If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (B), the individual appointed to fill the resulting 
                vacancy shall be appointed for the remainder of the 
                term of the predecessor of the individual.
            ``(5) Compensation.--Members of the Board may not receive 
        compensation for service on the Board. The members may be 
        reimbursed for travel, subsistence, and other necessary 
        expenses incurred in carrying out the duties of the Board.
    ``(f) Certain Responsibilities of Executive Director.--In carrying 
out subsection (d)(2), the Director shall carry out the following 
functions:
            ``(1) Hire, promote, compensate, and discharge officers and 
        employees of the Foundation, and define the duties of the 
        officers and employees.
            ``(2) Accept and administer donations to the Foundation, 
        and administer the assets of the Foundation.
            ``(3) Establish a process for the selection of candidates 
        for holding endowed positions under subsection (c).
            ``(4) Enter into such financial agreements as are 
        appropriate in carrying out the activities of the Foundation.
            ``(5) Take such action as may be necessary to acquire 
        patents and licenses for devices and procedures developed by 
        the Foundation and the employees of the Foundation.
            ``(6) Adopt, alter, and use a corporate seal, which shall 
        be judicially noticed.
            ``(7) Commence and respond to judicial proceedings in the 
        name of the Foundation.
            ``(8) Other functions that are appropriate in the 
        determination of the Director.
    ``(g) General Provisions.--
            ``(1) Authority for accepting funds.--The Director of the 
        Agency for Healthcare Quality may accept and utilize, on behalf 
        of the Federal Government, any gift, donation, bequest, or 
        devise of real or personal property from the Foundation for the 
        purpose of aiding or facilitating the work of such Agency. 
        Funds may be accepted and utilized by such Director under the 
        preceding sentence without regard to whether the funds are 
        designated as general-purpose funds or special-purpose funds. 
        Any funds transferred under this paragraph shall be subject to 
        all Federal limitations relating to federally funded research.
            ``(2) Authority for acceptance of voluntary services.--
                    ``(A) In general.--The Director of the Agency for 
                Healthcare Quality may accept, on behalf of the Federal 
                Government, any voluntary services provided to such 
                Agency by the Foundation for the purpose of aiding or 
                facilitating the work of such Agency. In the case of an 
                individual, such Director may accept the services 
                provided under the preceding sentence by the individual 
                for not more than 2 years.
                    ``(B) Limitation.--The limitation established in 
                subparagraph (A) regarding the period of time in which 
                services may be accepted applies to each individual who 
                is not an employee of the Federal Government and who 
                serves in association with the Agency for 
Healthcare Quality pursuant to financial support from the Foundation.
            ``(3) Administrative control.--No officer, employee, or 
        member of the Board of the Foundation may exercise any 
        administrative or managerial control over any Federal employee.
            ``(4) Applicability of certain standards to non-federal 
        employees.--In the case of any individual who is not an 
        employee of the Federal Government and who serves in 
        association with the Agency for Healthcare Quality pursuant to 
        financial support from the Foundation, the Foundation shall 
        negotiate a memorandum of understanding with the individual and 
        the Director of the Agency for Healthcare Quality specifying 
        that the individual--
                    ``(A) shall be subject to the ethical and 
                procedural standards regulating Federal employment, 
                scientific investigation, and research findings 
                (including publications and patents) that are required 
                of individuals employed by the Agency for Healthcare 
                Quality, including standards under this Act, the Ethics 
                in Government Act, and the Technology Transfer Act; and
                    ``(B) shall be subject to such ethical and 
                procedural standards under chapter 11 of title 18, 
                United States Code (relating to conflicts of interest), 
                as the Director of such Agency determines is 
                appropriate, except such memorandum may not provide 
                that the individual shall be subject to the standards 
                of section 209 of such chapter.
            ``(5) Financial conflicts of interest.--Any individual who 
        is an officer, employee, or member of the Board of the 
        Foundation may not directly or indirectly participate in the 
        consideration or determination by the Foundation of any 
        question affecting--
                    ``(A) any direct or indirect financial interest of 
                the individual; or
                    ``(B) any direct or indirect financial interest of 
                any business organization or other entity of which the 
                individual is an officer or employee or in which the 
                individual has a direct or indirect financial interest.
            ``(6) Audits; availability of records.--The Foundation 
        shall--
                    ``(A) provide for biennial audits of the financial 
                condition of the Foundation; and
                    ``(B) make such audits, and all other records, 
                documents, and other papers of the Foundation, 
                available to the Secretary and the Comptroller General 
                of the United States for examination or audit.
            ``(7) Reports.--
                    ``(A) In general.--Not later than February 1 of 
                each fiscal year, the Foundation shall publish a report 
                describing the activities of the Foundation during the 
                preceding fiscal year. Each such report shall include 
                for the fiscal year involved a comprehensive statement 
                of the operations, activities, financial condition, and 
                accomplishments of the Foundation.
                    ``(B) Financial requirement.--With respect to the 
                financial condition of the Foundation, each report 
                under subparagraph (A) shall include the source, and a 
                description of, all gifts to the Foundation of real or 
                personal property, and the source and amount of all 
                gifts to the Foundation of money. Each such report 
                shall include a specification of any restrictions on 
                the purposes for which gifts to the Foundation may be 
                used.
                    ``(C) Public inspection.--The Foundation shall make 
                copies of each report submitted under subparagraph (A) 
                available for public inspection, and shall upon request 
                provide a copy of the report to any individual for a 
                charge not exceeding the cost of providing the copy.
            ``(8) Liaison from the agency for healthcare quality.--The 
        Director of the Agency for Healthcare Quality shall serve as 
        the liaison representative of such Agency and the Foundation.
    ``(h) Federal Funding.--
            ``(1) Authority for financial support.--
                    ``(A) In general.--The Secretary, acting through 
                the Director of the Agency for Healthcare Quality, 
                shall--
                            ``(i) for fiscal year 1999, support the 
                        work of the Committee, established pursuant to 
                        subsection (i); and
                            ``(ii) for fiscal year 2000 and each 
                        subsequent fiscal year, make a grant to the 
                        Foundation.
                    ``(B) Limitations.--Financial support under 
                subparagraph (A) may be expended--
                            ``(i) in the case of the Committee, only 
                        for the purpose of carrying out the duties 
                        established in subsection (i); and
                            ``(ii) in the case of the Foundation, only 
                        for the purpose of the administrative expenses 
                        of the Foundation.
                    ``(C) Remaining funds.--For the purposes described 
                in subparagraph (B), any portion of the financial 
                support provided to the Committee under subparagraph 
                (A)(i) for fiscal year 1999 that remains unobligated 
                after the Committee completes the duties established in 
                subsection (i) shall be available to the Foundation.
            ``(2) Funds.--
                    ``(A) Authorization of appropriations.--For the 
                purpose of providing financial support under paragraph 
                (1), there is authorized to be appropriated for the 
                Foundation $500,000 for each fiscal year.
                    ``(B) Grants.--For the purpose of grants under 
                paragraph (1), the Secretary may for each fiscal year 
                make available not more than $500,000 from the amounts 
                appropriated for the fiscal year for the programs of 
                the Department of Health and Human Services. Such 
                amounts may be made available without regard to whether 
                amounts have been appropriated under subparagraph (A).
            ``(3) Certain restriction.--If the Foundation receives 
        Federal funds for the purpose of serving as a fiscal 
        intermediary between Federal agencies, the Foundation may not 
        receive such funds for the indirect costs of carrying out such 
        purpose in an amount exceeding 10 percent of the direct costs 
        of carrying out such purpose. The preceding sentence may not be 
        construed as authorizing the expenditure of any grant under 
        paragraph (1) for such purpose.
    ``(i) Establishment of Committee.--
            ``(1) In general.--The Secretary shall establish in 
        accordance with this subsection a committee (referred to in 
        this subsection as the `Committee') to carry out the functions 
        described in paragraph (2).
            ``(2) Functions.--The functions referred to in paragraph 
        (1) for the Committee are as follows:
                    ``(A) To carry out such activities as may be 
                necessary to incorporate the Foundation under the laws 
                of the State involved, including serving as 
                incorporators for the Foundation. Such activities shall 
                include ensuring that the articles of incorporation for 
                the Foundation require that the Foundation be 
                established and operated in accordance with the 
                applicable provisions of this part (or any successor to 
                this part), including such provisions as may be in 
                effect pursuant to amendments enacted after the date of 
                the enactment of the Healthcare Quality Enhancement Act 
                of 1998.
                    ``(B) To ensure that the Foundation qualifies for 
                and maintains the status described in subsection (d)(3) 
                (regarding taxation).
                    ``(C) To establish the general policies and initial 
                bylaws of the Foundation, which bylaws shall include 
                the bylaws described in subsections (d)(3) and (e)(1).
                    ``(D) To provide for the initial operation of the 
                Foundation, including providing for quarters, 
                equipment, and staff.
                    ``(E) To appoint the initial members of the Board 
                in accordance with the requirements established in 
                subsection (e)(2)(A) for the composition of the Board 
                and establish their respective terms, and other such 
                qualifications as the Committee may determine to be 
                appropriate.
            ``(3) Completion of functions of committee; initial meeting 
        of board.--
                    ``(A) In general.--The Committee shall complete the 
                functions required in paragraph (1) not later than 1 
                year following the appointment of the last member of 
                the Committee. The Committee shall terminate upon the 
                expiration of the 30-day period beginning on the date 
                on which the Secretary determines that the functions 
                have been completed.
                    ``(B) Initial meeting.--The initial meeting of the 
                Board shall be held not later than 90 days after the 
                Committee has completed its functions.
            ``(4) Composition.--The Committee shall be composed of 7 
        members, each of whom shall be a voting member. Of the members 
        of the Committee--
                    ``(A) not fewer than 2 members shall have broad, 
                general experience in healthcare; and
                    ``(B) not fewer than 2 members shall have broad, 
                general experience in the creation of a nonprofit 
                private organization, one of whom shall have expertise 
                in the legal structuring of nonprofit organizations 
                (without regard to whether the individuals have 
                experience in healthcare).
            ``(5) Chair.--The Committee shall, from among the members 
        of the Committee, designate an individual to serve as the chair 
        of the Committee.
            ``(6) Terms; vacancies.--The term of members of the 
        Committee shall be for the duration of the Committee. A vacancy 
        in the membership of the Committee shall not affect the power 
        of the Committee to carry out the duties of the Committee. If a 
        member of the Committee does not serve the full term, the 
        individual appointed to fill the resulting vacancy shall be 
        appointed for the remainder of the term of the predecessor of 
        the individual.
            ``(7) Compensation.--Members of the Committee may not 
        receive compensation for service on the Committee. Members of 
        the Committee may be reimbursed for travel, subsistence, and 
        other necessary expenses incurred in carrying out the duties of 
        the Committee.
            ``(8) Committee support.--The Director of the Agency for 
        Healthcare Quality may, from amounts available to the Director 
        for the general administration of such Agency, provide staff 
        and financial support to assist the Committee with carrying out 
        the functions described in paragraph (2). In providing such 
        staff and support, the Director may both detail employees and 
        contract for assistance.

``SEC. 923. 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 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 shall 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, records, reports, and 
                recommendations as confidential 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 the applicant 
                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 described in subsection (a)(1) 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 research, and for such other 
purposes as the Director may determine to be appropriate.
    ``(e) Regulations.--The Secretary shall issue regulations for the 
conduct of peer review under this section.

``SEC. 924. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, 
              AND DISSEMINATION OF DATA.

    ``(a) Standards With Respect to Utility of Data.--
            ``(1) In general.--With respect to data developed or 
        collected by any entity for the purpose described in section 
        901(b), the Director shall, in order to assure that utility, 
        accuracy, and sufficiency of such data for all interested 
        entities, establish recommendations for methods of developing 
        and collecting such data. Such recommendations shall include 
        recommendations for the development and collection of data on 
        the outcomes of healthcare services and procedures. Such 
        recommendations shall recognize the differences between types 
        of healthcare plans, delivery systems, healthcare providers, 
        and provider arrangements.
            ``(2) Relationship with medicare program.--In any case 
        where recommendations under paragraph (1) may affect the 
        administration of the program under title XVIII of the Social 
        Security Act, they shall be in the form of recommendations to 
        the Secretary for such program.
    ``(b) Statistics.--The Director shall--
            ``(1) take such action as may be necessary to assure that 
        statistics developed under this title are of high quality, 
        timely, and comprehensive, as well as specific, standardized, 
        and adequately analyzed and indexed; and
            ``(2) publish, make available, and disseminate such 
        statistics on as wide a basis as is practicable.
    ``(c) Authority Regarding Certain Requests.--Upon request of a 
public or private entity, the Director may undertake 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. 925. DISSEMINATION OF INFORMATION.

    ``(a) In General.--The Administrator 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) promptly make available to the public data developed 
        in such research, demonstration projects, and evaluations;
            ``(3) building upon information services provided by the 
        National Library of Medicine and considering applicable 
        interagency agreements, provide 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
            ``(4) 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 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 
under that section.

``SEC. 926. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND CONTRACTS.

    ``(a) Priorities.--In establishing priorities to carry out this 
title, subject to the availability of funds, the Director shall 
consider--
            ``(1) the needs and priorities of healthcare programs that 
        are operated by or supported, in whole or in part, by Federal 
        agencies;
            ``(2) the healthcare needs of low-income groups, minority 
        groups, children, the elderly, and persons with special 
        healthcare needs and issues related to the delivery of 
        healthcare services in rural areas (including frontier areas).
    ``(b) 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.
    ``(c) 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 in involved.
    ``(d) 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.
    ``(e) 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. 927. 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 debt of 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. 928. 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 $180,000,000 
for fiscal year 1999, and such sums as may be necessary for each of the 
fiscal years 2000 through 2003.
    ``(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.
    ``(d) Centers for Education and Research on Therapeutics.--For the 
purpose of carrying out the demonstration program regarding centers for 
education and research on therapeutics under section 912(b), there are 
authorized to be appropriated $2,000,000 for fiscal year 1998, and 
$3,000,000 for fiscal year 1999, and such sums as may be necessary for 
each of the fiscal years 2000 through 2003.

``SEC. 929. DEFINITIONS.

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

SEC. 4. 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 Quality''.
                                 <all>