106TH CONGRESS

1ST SESSION S. 580

AN ACT

To amend title IX of the Public Health Service Act to

revise and extend the Agency for Healthcare Policy and

Research.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Healthcare Research

5 and Quality Act of 1999’’.
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1 SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE

2 ACT.

3 (a) IN GENERAL.—Title IX of the Public Health

4 Service Act (42 U.S.C. 299 et seq.) is amended to read

5 as follows:

6 ‘‘TITLE IX—AGENCY FOR

7 HEALTHCARE RESEARCH

8 AND QUALITY

9 ‘‘PART A—ESTABLISHMENT AND GENERAL

10 DUTIES

11 ‘‘SEC. 901. MISSION AND DUTIES.

12 ‘‘(a) IN GENERAL.—There is established within the

13 Public Health Service an agency to be known as the Agen14 cy for Healthcare Research and Quality, which shall be

15 headed by a director appointed by the Secretary. The Sec16 retary shall carry out this title acting through the Direc17 tor.

18 ‘‘(b) MISSION.—The purpose of the Agency is to en19 hance the quality, appropriateness, and effectiveness of

20 health services, and access to such services, through the

21 establishment of a broad base of scientific research and

22 through the promotion of improvements in clinical and

23 health system practices, including the prevention of dis24 eases and other health conditions. The Agency shall pro25 mote health care quality improvement by conducting and

26 supporting—
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1 ‘‘(1) research that develops and presents sci2 entific evidence regarding all aspects of health care,

3 including—

4 ‘‘(A) the development and assessment of

5 methods for enhancing patient participation in

6 their own care and for facilitating shared pa7 tient-physician decision-making;

8 ‘‘(B) the outcomes, effectiveness, and cost9 effectiveness of health care practices, including

10 preventive measures and long-term care;

11 ‘‘(C) existing and innovative technologies;

12 ‘‘(D) the costs and utilization of, and ac13 cess to health care;

14 ‘‘(E) the ways in which health care services

15 are organized, delivered, and financed and the

16 interaction and impact of these factors on the

17 quality of patient care;

18 ‘‘(F) methods for measuring quality and

19 strategies for improving quality; and

20 ‘‘(G) ways in which patients, consumers,

21 purchasers, and practitioners acquire new infor22 mation about best practices and health benefits,

23 the determinants and impact of their use of this

24 information;
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1 ‘‘(2) the synthesis and dissemination of avail2 able scientific evidence for use by patients, con3 sumers, practitioners, providers, purchasers, policy

4 makers, and educators; and

5 ‘‘(3) initiatives to advance private and public ef6 forts to improve health care quality.

7 ‘‘(c) REQUIREMENTS WITH RESPECT TO RURAL AND

8 INNER-CITY AREAS AND PRIORITY POPULATIONS.—

9 ‘‘(1) RESEARCH, EVALUATIONS AND DEM10 ONSTRATION PROJECTS.—In carrying out this title,

11 the Director shall conduct and support research and

12 evaluations, and support demonstration projects,

13 with respect to—

14 ‘‘(A) the delivery of health care in inner15 city areas, and in rural areas (including frontier

16 areas); and

17 ‘‘(B) health care for priority populations,

18 which shall include—

19 ‘‘(i) low-income groups;

20 ‘‘(ii) minority groups;

21 ‘‘(iii) women;

22 ‘‘(iv) children;

23 ‘‘(v) the elderly; and

24 ‘‘(vi) individuals with special health

25 care needs, including individuals with dis-
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1 abilities and individuals who need chronic

2 care or end-of-life health care.

3 ‘‘(2) PROCESS TO ENSURE APPROPRIATE RE4 SEARCH.—The Director shall establish a process to

5 ensure that the requirements of paragraph (1) are

6 reflected in the overall portfolio of research con7 ducted and supported by the Agency.

8 ‘‘(3) OFFICE OF PRIORITY POPULATIONS.—The

9 Director shall establish an Office of Priority Popu10 lations to assist in carrying out the requirements of

11 paragraph (1).

12 ‘‘SEC. 902. GENERAL AUTHORITIES.

13 ‘‘(a) IN GENERAL.—In carrying out section 901(b),

14 the Director shall conduct and support research, evalua15 tions, and training, support demonstration projects, re16 search networks, and multi-disciplinary centers, provide

17 technical assistance, and disseminate information on

18 health care and on systems for the delivery of such care,

19 including activities with respect to—

20 ‘‘(1) the quality, effectiveness, efficiency, appro21 priateness and value of health care services;

22 ‘‘(2) quality measurement and improvement;

23 ‘‘(3) the outcomes, cost, cost-effectiveness, and

24 use of health care services and access to such serv25 ices;
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1 ‘‘(4) clinical practice, including primary care

2 and practice-oriented research;

3 ‘‘(5) health care technologies, facilities, and

4 equipment;

5 ‘‘(6) health care costs, productivity, organiza6 tion, and market forces;

7 ‘‘(7) health promotion and disease prevention,

8 including clinical preventive services;

9 ‘‘(8) health statistics, surveys, database devel10 opment, and epidemiology; and

11 ‘‘(9) medical liability.

12 ‘‘(b) HEALTH SERVICES TRAINING GRANTS.—

13 ‘‘(1) IN GENERAL.—The Director may provide

14 training grants in the field of health services re15 search related to activities authorized under sub16 section (a), to include pre- and post-doctoral fellow17 ships and training programs, young investigator

18 awards, and other programs and activities as appro19 priate. In carrying out this subsection, the Director

20 shall make use of funds made available under sec21 tion 487(d)(3) as well as other appropriated funds.

22 ‘‘(2) REQUIREMENTS.—In developing priorities

23 for the allocation of training funds under this sub24 section, the Director shall take into consideration

25 shortages in the number of trained researchers who
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1 are addressing health care issues for the priority

2 populations identified in section 901(c)(1)(B) and in

3 addition, shall take into consideration indications of

4 long-term commitment, amongst applicants for

5 training funds, to addressing health care needs of

6 the priority populations.

7 ‘‘(c) MULTIDISCIPLINARY CENTERS.—The Director

8 may provide financial assistance to assist in meeting the

9 costs of planning and establishing new centers, and oper10 ating existing and new centers, for multidisciplinary

11 health services research, demonstration projects, evalua12 tions, training, and policy analysis with respect to the mat13 ters referred to in subsection (a).

14 ‘‘(d) RELATION TO CERTAIN AUTHORITIES REGARD15 ING SOCIAL SECURITY.—Activities authorized in this sec16 tion shall be appropriately coordinated with experiments,

17 demonstration projects, and other related activities au18 thorized by the Social Security Act and the Social Security

19 Amendments of 1967. Activities under subsection (a)(2)

20 of this section that affect the programs under titles XVIII,

21 XIX and XXI of the Social Security Act shall be carried

22 out consistent with section 1142 of such Act.

23 ‘‘(e) DISCLAIMER.—The Agency shall not mandate

24 national standards of clinical practice or quality health

25 care standards. Recommendations resulting from projects
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1 funded and published by the Agency shall include a cor2 responding disclaimer.

3 ‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec4 tion shall be construed to imply that the Agency’s role is

5 to mandate a national standard or specific approach to

6 quality measurement and reporting. In research and qual7 ity improvement activities, the Agency shall consider a

8 wide range of choices, providers, health care delivery sys9 tems, and individual preferences.

10 ‘‘(g) ANNUAL REPORT.—Beginning with fiscal year

11 2003, the Director shall annually submit to the Congress

12 a report regarding prevailing disparities in health care de13 livery as it relates to racial factors and socioeconomic fac14 tors in priority populations.

15 ‘‘PART B—HEALTH CARE IMPROVEMENT

16 RESEARCH

17 ‘‘SEC. 911. HEALTH CARE OUTCOME IMPROVEMENT RE18 SEARCH.

19 ‘‘(a) EVIDENCE RATING SYSTEMS.—In collaboration

20 with experts from the public and private sector, the Agen21 cy shall identify and disseminate methods or systems to

22 assess health care research results, particularly methods

23 or systems to rate the strength of the scientific evidence

24 underlying health care practice, recommendations in the

25 research literature, and technology assessments. The
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1 Agency shall make methods or systems for evidence rating

2 widely available. Agency publications containing health

3 care recommendations shall indicate the level of substan4 tiating evidence using such methods or systems.

5 ‘‘(b) HEALTH CARE IMPROVEMENT RESEARCH CEN6 TERS AND PROVIDER-BASED RESEARCH NETWORKS.—

7 ‘‘(1) IN GENERAL.—In order to address the full

8 continuum of care and outcomes research, to link re9 search to practice improvement, and to speed the

10 dissemination of research findings to community

11 practice settings, the Agency shall employ research

12 strategies and mechanisms that will link research di13 rectly with clinical practice in geographically diverse

14 locations throughout the United States, including—

15 ‘‘(A) health care improvement research

16 centers that combine demonstrated multidisci17 plinary expertise in outcomes or quality im18 provement research with linkages to relevant

19 sites of care;

20 ‘‘(B) provider-based research networks, in21 cluding plan, facility, or delivery system sites of

22 care (especially primary care), that can evaluate

23 outcomes and evaluate and promote quality im24 provement; and
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1 ‘‘(C) other innovative mechanisms or strat2 egies to link research with clinical practice.

3 ‘‘(2) REQUIREMENTS.—The Director is author4 ized to establish the requirements for entities apply5 ing for grants under this subsection.

6 ‘‘SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE

7 ORGANIZATION AND DELIVERY.

8 ‘‘(a) SUPPORT FOR EFFORTS TO DEVELOP INFOR9 MATION ON QUALITY.—

10 ‘‘(1) SCIENTIFIC AND TECHNICAL SUPPORT.—

11 In its role as the principal agency for health care re12 search and quality, the Agency may provide sci13 entific and technical support for private and public

14 efforts to improve health care quality, including the

15 activities of accrediting organizations.

16 ‘‘(2) ROLE OF THE AGENCY.—With respect to

17 paragraph (1), the role of the Agency shall include—

18 ‘‘(A) the identification and assessment of

19 methods for the evaluation of the health of—

20 ‘‘(i) enrollees in health plans by type

21 of plan, provider, and provider arrange22 ments; and

23 ‘‘(ii) other populations, including

24 those receiving long-term care services;
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1 ‘‘(B) the ongoing development, testing, and

2 dissemination of quality measures, including

3 measures of health and functional outcomes;

4 ‘‘(C) the compilation and dissemination of

5 health care quality measures developed in the

6 private and public sector;

7 ‘‘(D) assistance in the development of im8 proved health care information systems;

9 ‘‘(E) the development of survey tools for

10 the purpose of measuring participant and bene11 ficiary assessments of their health care; and

12 ‘‘(F) identifying and disseminating infor13 mation on mechanisms for the integration of in14 formation on quality into purchaser and con15 sumer decision-making processes.

16 ‘‘(b) CENTERS FOR EDUCATION AND RESEARCH ON

17 THERAPEUTICS.—

18 ‘‘(1) IN GENERAL.—The Secretary, acting

19 through the Director and in consultation with the

20 Commissioner of Food and Drugs, shall establish a

21 program for the purpose of making one or more

22 grants for the establishment and operation of one or

23 more centers to carry out the activities specified in

24 paragraph (2).
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1 ‘‘(2) REQUIRED ACTIVITIES.—The activities re2 ferred to in this paragraph are the following:

3 ‘‘(A) The conduct of state-of-the-art re4 search for the following purposes:

5 ‘‘(i) To increase awareness of—

6 ‘‘(I) new uses of drugs, biological

7 products, and devices;

8 ‘‘(II) ways to improve the effec9 tive use of drugs, biological products,

10 and devices; and

11 ‘‘(III) risks of new uses and risks

12 of combinations of drugs and biologi13 cal products.

14 ‘‘(ii) To provide objective clinical in15 formation to the following individuals and

16 entities:

17 ‘‘(I) Health care practitioners

18 and other providers of health care

19 goods or services.

20 ‘‘(II) Pharmacists, pharmacy

21 benefit managers and purchasers.

22 ‘‘(III) Health maintenance orga23 nizations and other managed health

24 care organizations.
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1 ‘‘(IV) Health care insurers and

2 governmental agencies.

3 ‘‘(V) Patients and consumers.

4 ‘‘(iii) To improve the quality of health

5 care while reducing the cost of health care

6 through—

7 ‘‘(I) an increase in the appro8 priate use of drugs, biological prod9 ucts, or devices; and

10 ‘‘(II) the prevention of adverse

11 effects of drugs, biological products,

12 and devices and the consequences of

13 such effects, such as unnecessary hos14 pitalizations.

15 ‘‘(B) The conduct of research on the com16 parative effectiveness, cost-effectiveness, and

17 safety of drugs, biological products, and devices.

18 ‘‘(C) Such other activities as the Secretary

19 determines to be appropriate, except that a

20 grant may not be expended to assist the Sec21 retary in the review of new drugs, biological

22 products, and devices.

23 ‘‘(c) REDUCING ERRORS IN MEDICINE.—The Direc24 tor shall conduct and support research and build private25 public partnerships to—
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1 ‘‘(1) identify the causes of preventable health

2 care errors and patient injury in health care deliv3 ery;

4 ‘‘(2) develop, demonstrate, and evaluate strate5 gies for reducing errors and improving patient safe6 ty; and

7 ‘‘(3) disseminate such effective strategies

8 throughout the health care industry.

9 ‘‘SEC. 913. INFORMATION ON QUALITY AND COST OF CARE.

10 ‘‘(a) IN GENERAL.—The Director shall—

11 ‘‘(1) conduct a survey to collect data on a na12 tionally representative sample of the population on

13 the cost, use and, for fiscal year 2001 and subse14 quent fiscal years, quality of health care, including

15 the types of health care services Americans use,

16 their access to health care services, frequency of use,

17 how much is paid for the services used, the source

18 of those payments, the types and costs of private

19 health insurance, access, satisfaction, and quality of

20 care for the general population including rural resi21 dents and also for populations identified in section

22 901(c); and

23 ‘‘(2) develop databases and tools that provide

24 information to States on the quality, access, and use

25 of health care services provided to their residents.
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1 ‘‘(b) QUALITY AND OUTCOMES INFORMATION.—

2 ‘‘(1) IN GENERAL.—Beginning in fiscal year

3 2001, the Director shall ensure that the survey con4 ducted under subsection (a)(1) will—

5 ‘‘(A) identify determinants of health out6 comes and functional status, including the

7 health care needs of populations identified in

8 section 901(c), provide data to study the rela9 tionships between health care quality, outcomes,

10 access, use, and cost, measure changes over

11 time, and monitor the overall national impact of

12 Federal and State policy changes on health

13 care;

14 ‘‘(B) provide information on the quality of

15 care and patient outcomes for frequently occur16 ring clinical conditions for a nationally rep17 resentative sample of the population including

18 rural residents; and

19 ‘‘(C) provide reliable national estimates for

20 children and persons with special health care

21 needs through the use of supplements or peri22 odic expansions of the survey.

23 In expanding the Medical Expenditure Panel Survey,

24 as in existence on the date of the enactment of this

25 title in fiscal year 2001 to collect information on the
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1 quality of care, the Director shall take into account

2 any outcomes measurements generally collected by

3 private sector accreditation organizations.

4 ‘‘(2) ANNUAL REPORT.—Beginning in fiscal

5 year 2003, the Secretary, acting through the Direc6 tor, shall submit to Congress an annual report on

7 national trends in the quality of health care provided

8 to the American people.

9 ‘‘SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IM10 PROVEMENT.

11 ‘‘(a) IN GENERAL.—In order to foster a range of in12 novative approaches to the management and communica13 tion of health information, the Agency shall conduct and

14 support research, evaluations, and initiatives to advance—

15 ‘‘(1) the use of information systems for the

16 study of health care quality and outcomes, including

17 the generation of both individual provider and plan18 level comparative performance data;

19 ‘‘(2) training for health care practitioners and

20 researchers in the use of information systems;

21 ‘‘(3) the creation of effective linkages between

22 various sources of health information, including the

23 development of information networks;
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1 ‘‘(4) the delivery and coordination of evidence2 based health care services, including the use of real3 time health care decision-support programs;

4 ‘‘(5) the utility and comparability of health in5 formation data and medical vocabularies by address6 ing issues related to the content, structure, defini7 tions and coding of such information and data in

8 consultation with appropriate Federal, State and

9 private entities;

10 ‘‘(6) the use of computer-based health records

11 in all settings for the development of personal health

12 records for individual health assessment and mainte13 nance, and for monitoring public health and out14 comes of care within populations; and

15 ‘‘(7) the protection of individually identifiable

16 information in health services research and health

17 care quality improvement.

18 ‘‘(b) DEMONSTRATION.—The Agency shall support

19 demonstrations into the use of new information tools

20 aimed at improving shared decision-making between pa21 tients and their care-givers.

22 ‘‘(c) FACILITATING PUBLIC ACCESS TO INFORMA23 TION.—The Director shall work with appropriate public

24 and private sector entities to facilitate public access to in-
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1 formation regarding the quality of and consumer satisfac2 tion with health care.

3 ‘‘SEC. 915. RESEARCH SUPPORTING PRIMARY CARE AND

4 ACCESS IN UNDERSERVED AREAS.

5 ‘‘(a) PREVENTIVE SERVICES TASK FORCE.—

6 ‘‘(1) ESTABLISHMENT AND PURPOSE.—The Di7 rector may periodically convene a Preventive Serv8 ices Task Force to be composed of individuals with

9 appropriate expertise. Such a task force shall review

10 the scientific evidence related to the effectiveness,

11 appropriateness, and cost-effectiveness of clinical

12 preventive services for the purpose of developing rec13 ommendations for the health care community, and

14 updating previous clinical preventive recommenda15 tions.

16 ‘‘(2) ROLE OF AGENCY.—The Agency shall pro17 vide ongoing administrative, research, and technical

18 support for the operations of the Preventive Services

19 Task Force, including coordinating and supporting

20 the dissemination of the recommendations of the

21 Task Force.

22 ‘‘(3) OPERATION.—In carrying out its respon23 sibilities under paragraph (1), the Task Force is not

24 subject to the provisions of Appendix 2 of title 5,

25 United States Code.
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1 ‘‘(b) PRIMARY CARE RESEARCH.—

2 ‘‘(1) IN GENERAL.—There is established within

3 the Agency a Center for Primary Care Research (re4 ferred to in this subsection as the ‘Center’) that

5 shall serve as the principal source of funding for pri6 mary care practice research in the Department of

7 Health and Human Services. For purposes of this

8 paragraph, primary care research focuses on the

9 first contact when illness or health concerns arise,

10 the diagnosis, treatment or referral to specialty care,

11 preventive care, and the relationship between the cli12 nician and the patient in the context of the family

13 and community.

14 ‘‘(2) RESEARCH.—In carrying out this section,

15 the Center shall conduct and support research

16 concerning—

17 ‘‘(A) the nature and characteristics of pri18 mary care practice;

19 ‘‘(B) the management of commonly occur20 ring clinical problems;

21 ‘‘(C) the management of undifferentiated

22 clinical problems; and

23 ‘‘(D) the continuity and coordination of

24 health services.
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1 ‘‘SEC. 916. HEALTH CARE PRACTICE AND TECHNOLOGY IN2 NOVATION.

3 ‘‘(a) IN GENERAL.—The Director shall promote inno4 vation in evidence-based health care practices and tech5 nologies by—

6 ‘‘(1) conducting and supporting research on the

7 development, diffusion, and use of health care tech8 nology;

9 ‘‘(2) developing, evaluating, and disseminating

10 methodologies for assessments of health care prac11 tices and technologies;

12 ‘‘(3) conducting intramural and supporting ex13 tramural assessments of existing and new health

14 care practices and technologies;

15 ‘‘(4) promoting education and training and pro16 viding technical assistance in the use of health care

17 practice and technology assessment methodologies

18 and results; and

19 ‘‘(5) working with the National Library of Med20 icine and the public and private sector to develop an

21 electronic clearinghouse of currently available assess22 ments and those in progress.

23 ‘‘(b) SPECIFICATION OF PROCESS.—

24 ‘‘(1) IN GENERAL.—Not later than December

25 31, 2000, the Director shall develop and publish a

26 description of the methods used by the Agency and
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1 its contractors for health care practice and tech2 nology assessment.

3 ‘‘(2) CONSULTATIONS.—In carrying out this

4 subsection, the Director shall cooperate and consult

5 with the Assistant Secretary for Health, the Admin6 istrator of the Health Care Financing Administra7 tion, the Director of the National Institutes of

8 Health, the Commissioner of Food and Drugs, and

9 the heads of any other interested Federal depart10 ment or agency, and shall seek input, where appro11 priate, from professional societies and other private

12 and public entities.

13 ‘‘(3) METHODOLOGY.—The Director shall, in

14 developing the methods used under paragraph (1),

15 consider—

16 ‘‘(A) safety, efficacy, and effectiveness;

17 ‘‘(B) legal, social, and ethical implications;

18 ‘‘(C) costs, benefits, and cost-effectiveness;

19 ‘‘(D) comparisons to alternate health care

20 practices and technologies; and

21 ‘‘(E) requirements of Food and Drug Ad22 ministration approval to avoid duplication.

23 ‘‘(c) SPECIFIC ASSESSMENTS.—
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1 ‘‘(1) IN GENERAL.—The Director shall conduct

2 or support specific assessments of health care tech3 nologies and practices.

4 ‘‘(2) REQUESTS FOR ASSESSMENTS.—The Di5 rector is authorized to conduct or support assess6 ments, on a reimbursable basis, for the Health Care

7 Financing Administration, the Department of De8 fense, the Department of Veterans Affairs, the Of9 fice of Personnel Management, and other public or

10 private entities.

11 ‘‘(3) GRANTS AND CONTRACTS.—In addition to

12 conducting assessments, the Director may make

13 grants to, or enter into cooperative agreements or

14 contracts with, entities described in paragraph (4)

15 for the purpose of conducting assessments of experi16 mental, emerging, existing, or potentially outmoded

17 health care technologies, and for related activities.

18 ‘‘(4) ELIGIBLE ENTITIES.—An entity described

19 in this paragraph is an entity that is determined to

20 be appropriate by the Director, including academic

21 medical centers, research institutions and organiza22 tions, professional organizations, third party payers,

23 governmental agencies, minority institutions of high24 er education (such as Historically Black Colleges

25 and Universities, and Hispanic institutions), and
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1 consortia of appropriate research entities established

2 for the purpose of conducting technology assess3 ments.

4 ‘‘(d) MEDICAL EXAMINATION OF CERTAIN VIC5 TIMS.—

6 ‘‘(1) IN GENERAL.—The Director shall develop

7 and disseminate a report on evidence-based clinical

8 practices for—

9 ‘‘(A) the examination and treatment by

10 health professionals of individuals who are vic11 tims of sexual assault (including child molesta12 tion) or attempted sexual assault; and

13 ‘‘(B) the training of health professionals,

14 in consultation with the Health Resources and

15 Services Administration, on performing medical

16 evidentiary examinations of individuals who are

17 victims of child abuse or neglect, sexual assault,

18 elder abuse, or domestic violence.

19 ‘‘(2) CERTAIN CONSIDERATIONS.—In identi20 fying the issues to be addressed by the report, the

21 Director shall, to the extent practicable, take into

22 consideration the expertise and experience of Federal

23 and State law enforcement officials regarding the

24 victims referred to in paragraph (1), and of other

25 appropriate public and private entities (including
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1 medical societies, victim services organizations, sex2 ual assault prevention organizations, and social serv3 ices organizations).

4 ‘‘SEC. 917. COORDINATION OF FEDERAL GOVERNMENT

5 QUALITY IMPROVEMENT EFFORTS.

6 ‘‘(a) REQUIREMENT.—

7 ‘‘(1) IN GENERAL.—To avoid duplication and

8 ensure that Federal resources are used efficiently

9 and effectively, the Secretary, acting through the Di10 rector, shall coordinate all research, evaluations, and

11 demonstrations related to health services research,

12 quality measurement and quality improvement ac13 tivities undertaken and supported by the Federal

14 Government.

15 ‘‘(2) SPECIFIC ACTIVITIES.—The Director, in

16 collaboration with the appropriate Federal officials

17 representing all concerned executive agencies and de18 partments, shall develop and manage a process to—

19 ‘‘(A) improve interagency coordination, pri20 ority setting, and the use and sharing of re21 search findings and data pertaining to Federal

22 quality improvement programs, technology as23 sessment, and health services research;

24 ‘‘(B) strengthen the research information

25 infrastructure, including databases, pertaining
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1 to Federal health services research and health

2 care quality improvement initiatives;

3 ‘‘(C) set specific goals for participating

4 agencies and departments to further health

5 services research and health care quality im6 provement; and

7 ‘‘(D) strengthen the management of Fed8 eral health care quality improvement programs.

9 ‘‘(b) STUDY BY THE INSTITUTE OF MEDICINE.—

10 ‘‘(1) IN GENERAL.—To provide Congress, the

11 Department of Health and Human Services, and

12 other relevant departments with an independent, ex13 ternal review of their quality oversight, quality im14 provement and quality research programs, the Sec15 retary shall enter into a contract with the Institute

16 of Medicine—

17 ‘‘(A) to describe and evaluate current qual18 ity improvement, quality research and quality

19 monitoring processes through—

20 ‘‘(i) an overview of pertinent health

21 services research activities and quality im22 provement efforts conducted by all Federal

23 programs, with particular attention paid to

24 those under titles XVIII, XIX, and XXI of

25 the Social Security Act; and
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1 ‘‘(ii) a summary of the partnerships

2 that the Department of Health and

3 Human Services has pursued with private

4 accreditation, quality measurement and

5 improvement organizations; and

6 ‘‘(B) to identify options and make rec7 ommendations to improve the efficiency and ef8 fectiveness of quality improvement programs

9 through—

10 ‘‘(i) the improved coordination of ac11 tivities across the medicare, medicaid and

12 child health insurance programs under ti13 tles XVIII, XIX and XXI of the Social Se14 curity Act and health services research

15 programs;

16 ‘‘(ii) the strengthening of patient

17 choice and participation by incorporating

18 state-of-the-art quality monitoring tools

19 and making information on quality avail20 able; and

21 ‘‘(iii) the enhancement of the most ef22 fective programs, consolidation as appro23 priate, and elimination of duplicative ac24 tivities within various federal agencies.

25 ‘‘(2) REQUIREMENTS.—
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1 ‘‘(A) IN GENERAL.—The Secretary shall

2 enter into a contract with the Institute of Medi3 cine for the preparation—

4 ‘‘(i) not later than 12 months after

5 the date of the enactment of this title, of

6 a report providing an overview of the qual7 ity improvement programs of the Depart8 ment of Health and Human Services for

9 the medicare, medicaid, and CHIP pro10 grams under titles XVIII, XIX, and XXI

11 of the Social Security Act; and

12 ‘‘(ii) not later than 24 months after

13 the date of the enactment of this title, of

14 a final report containing recommendations.

15 ‘‘(B) REPORTS.—The Secretary shall sub16 mit the reports described in subparagraph (A)

17 to the Committee on Finance and the Com18 mittee on Health, Education, Labor, and Pen19 sions of the Senate and the Committee on Ways

20 and Means and the Committee on Commerce of

21 the House of Representatives.
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1 ‘‘PART C—GENERAL PROVISIONS

2 ‘‘SEC. 921. ADVISORY COUNCIL FOR HEALTHCARE RE3 SEARCH AND QUALITY.

4 ‘‘(a) ESTABLISHMENT.—There is established an advi5 sory council to be known as the National Advisory Council

6 for Healthcare Research and Quality.

7 ‘‘(b) DUTIES.—

8 ‘‘(1) IN GENERAL.—The Advisory Council shall

9 advise the Secretary and the Director with respect

10 to activities proposed or undertaken to carry out the

11 mission of the Agency under section 901(b).

12 ‘‘(2) CERTAIN RECOMMENDATIONS.—Activities

13 of the Advisory Council under paragraph (1) shall

14 include making recommendations to the Director

15 regarding—

16 ‘‘(A) priorities regarding health care re17 search, especially studies related to quality, out18 comes, cost and the utilization of, and access

19 to, health care services;

20 ‘‘(B) the field of health care research and

21 related disciplines, especially issues related to

22 training needs, and dissemination of informa23 tion pertaining to health care quality; and

24 ‘‘(C) the appropriate role of the Agency in

25 each of these areas in light of private sector ac-
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1 tivity and identification of opportunities for

2 public-private sector partnerships.

3 ‘‘(c) MEMBERSHIP.—

4 ‘‘(1) IN GENERAL.—The Advisory Council shall,

5 in accordance with this subsection, be composed of

6 appointed members and ex officio members. All

7 members of the Advisory Council shall be voting

8 members other than the individuals designated

9 under paragraph (3)(B) as ex officio members.

10 ‘‘(2) APPOINTED MEMBERS.—The Secretary

11 shall appoint to the Advisory Council 21 appro12 priately qualified individuals. At least 17 members of

13 the Advisory Council shall be representatives of the

14 public who are not officers or employees of the

15 United States and at least 1 member who shall be

16 a specialist in the rural aspects of 1 or more of the

17 professions or fields described in subparagraphs (A)

18 through (G). The Secretary shall ensure that the ap19 pointed members of the Council, as a group, are rep20 resentative of professions and entities concerned

21 with, or affected by, activities under this title and

22 under section 1142 of the Social Security Act. Of

23 such members—

24 ‘‘(A) three shall be individuals distin25 guished in the conduct of research, demonstra-
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1 tion projects, and evaluations with respect to

2 health care;

3 ‘‘(B) three shall be individuals distin4 guished in the fields of health care quality re5 search or health care improvement;

6 ‘‘(C) three shall be individuals distin7 guished in the practice of medicine of which at

8 least one shall be a primary care practitioner;

9 ‘‘(D) three shall be individuals distin10 guished in the other health professions;

11 ‘‘(E) three shall be individuals either rep12 resenting the private health care sector, includ13 ing health plans, providers, and purchasers or

14 individuals distinguished as administrators of

15 health care delivery systems;

16 ‘‘(F) three shall be individuals distin17 guished in the fields of health care economics,

18 information systems, law, ethics, business, or

19 public policy; and

20 ‘‘(G) three shall be individuals representing

21 the interests of patients and consumers of

22 health care.

23 ‘‘(3) EX OFFICIO MEMBERS.—The Secretary

24 shall designate as ex officio members of the Advisory

25 Council—
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1 ‘‘(A) the Assistant Secretary for Health,

2 the Director of the National Institutes of

3 Health, the Director of the Centers for Disease

4 Control and Prevention, the Administrator of

5 the Health Care Financing Administration, the

6 Commissioner of the Food and Drug Adminis7 tration, the Director of the Office of Personnel

8 Management, the Assistant Secretary of De9 fense (Health Affairs), and the Under Secretary

10 for Health of the Department of Veterans Af11 fairs; and

12 ‘‘(B) such other Federal officials as the

13 Secretary may consider appropriate.

14 ‘‘(d) TERMS.—

15 ‘‘(1) IN GENERAL.—Members of the Advisory

16 Council appointed under subsection (c)(2) shall serve

17 for a term of 3 years.

18 ‘‘(2) STAGGERED TERMS.—To ensure the stag19 gered rotation of one-third of the members of the

20 Advisory Council each year, the Secretary is author21 ized to appoint the initial members of the Advisory

22 Council for terms of 1, 2, or 3 years.

23 ‘‘(3) SERVICE BEYOND TERM.—A member of

24 the Council appointed under subsection (c)(2) may
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1 continue to serve after the expiration of the term of

2 the members until a successor is appointed.

3 ‘‘(e) VACANCIES.—If a member of the Advisory

4 Council appointed under subsection (c)(2) does not serve

5 the full term applicable under subsection (d), the indi6 vidual appointed to fill the resulting vacancy shall be ap7 pointed for the remainder of the term of the predecessor

8 of the individual.

9 ‘‘(f) CHAIR.—The Director shall, from among the

10 members of the Advisory Council appointed under sub11 section (c)(2), designate an individual to serve as the chair

12 of the Advisory Council.

13 ‘‘(g) MEETINGS.—The Advisory Council shall meet

14 not less than once during each discrete 4-month period

15 and shall otherwise meet at the call of the Director or the

16 chair.

17 ‘‘(h) COMPENSATION AND REIMBURSEMENT OF EX18 PENSES.—

19 ‘‘(1) APPOINTED MEMBERS.—Members of the

20 Advisory Council appointed under subsection (c)(2)

21 shall receive compensation for each day (including

22 travel time) engaged in carrying out the duties of

23 the Advisory Council unless declined by the member.

24 Such compensation may not be in an amount in ex25 cess of the daily equivalent of the annual rate of
33

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1 basic pay prescribed for level IV of the Executive

2 Schedule under section 5315 of title 5, United

3 States Code, for each day during which such mem4 ber is engaged in the performance of the duties of

5 the Advisory Council.

6 ‘‘(2) EX OFFICIO MEMBERS.—Officials des7 ignated under subsection (c)(3) as ex officio mem8 bers of the Advisory Council may not receive com9 pensation for service on the Advisory Council in ad10 dition to the compensation otherwise received for du11 ties carried out as officers of the United States.

12 ‘‘(i) STAFF.—The Director shall provide to the Advi13 sory Council such staff, information, and other assistance

14 as may be necessary to carry out the duties of the Council.

15 ‘‘(j) DURATION.—Notwithstanding section 14(a) of

16 the Federal Advisory Committee Act, the Advisory Council

17 shall continue in existence until otherwise provided by law.

18 ‘‘SEC. 922. PEER REVIEW WITH RESPECT TO GRANTS AND

19 CONTRACTS.

20 ‘‘(a) REQUIREMENT OF REVIEW.—

21 ‘‘(1) IN GENERAL.—Appropriate technical and

22 scientific peer review shall be conducted with respect

23 to each application for a grant, cooperative agree24 ment, or contract under this title.
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1 ‘‘(2) REPORTS TO DIRECTOR.—Each peer re2 view group to which an application is submitted pur3 suant to paragraph (1) shall report its finding and

4 recommendations respecting the application to the

5 Director in such form and in such manner as the

6 Director shall require.

7 ‘‘(b) APPROVAL AS PRECONDITION OF AWARDS.—

8 The Director may not approve an application described in

9 subsection (a)(1) unless the application is recommended

10 for approval by a peer review group established under sub11 section (c).

12 ‘‘(c) ESTABLISHMENT OF PEER REVIEW GROUPS.—

13 ‘‘(1) IN GENERAL.—The Director shall establish

14 such technical and scientific peer review groups as

15 may be necessary to carry out this section. Such

16 groups shall be established without regard to the

17 provisions of title 5, United States Code, that govern

18 appointments in the competitive service, and without

19 regard to the provisions of chapter 51, and sub20 chapter III of chapter 53, of such title that relate

21 to classification and pay rates under the General

22 Schedule.

23 ‘‘(2) MEMBERSHIP.—The members of any peer

24 review group established under this section shall be

25 appointed from among individuals who by virtue of
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1 their training or experience are eminently qualified

2 to carry out the duties of such peer review group.

3 Officers and employees of the United States may not

4 constitute more than 25 percent of the membership

5 of any such group. Such officers and employees may

6 not receive compensation for service on such groups

7 in addition to the compensation otherwise received

8 for these duties carried out as such officers and em9 ployees.

10 ‘‘(3) DURATION.—Notwithstanding section

11 14(a) of the Federal Advisory Committee Act, peer

12 review groups established under this section may

13 continue in existence until otherwise provided by

14 law.

15 ‘‘(4) QUALIFICATIONS.—Members of any peer16 review group shall, at a minimum, meet the fol17 lowing requirements:

18 ‘‘(A) Such members shall agree in writing

19 to treat information received, pursuant to their

20 work for the group, as confidential information,

21 except that this subparagraph shall not apply to

22 public records and public information.

23 ‘‘(B) Such members shall agree in writing

24 to recuse themselves from participation in the

25 peer-review of specific applications which
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1 present a potential personal conflict of interest

2 or appearance of such conflict, including em3 ployment in a directly affected organization,

4 stock ownership, or any financial or other ar5 rangement that might introduce bias in the

6 process of peer-review.

7 ‘‘(d) AUTHORITY FOR PROCEDURAL ADJUSTMENTS

8 IN CERTAIN CASES.—In the case of applications for finan9 cial assistance whose direct costs will not exceed $100,000,

10 the Director may make appropriate adjustments in the

11 procedures otherwise established by the Director for the

12 conduct of peer review under this section. Such adjust13 ments may be made for the purpose of encouraging the

14 entry of individuals into the field of research, for the pur15 pose of encouraging clinical practice-oriented or provider16 based research, and for such other purposes as the Direc17 tor may determine to be appropriate.

18 ‘‘(e) REGULATIONS.—The Director shall issue regula19 tions for the conduct of peer review under this section.

20 ‘‘SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVEL21 OPMENT, COLLECTION, AND DISSEMINATION

22 OF DATA.

23 ‘‘(a) STANDARDS WITH RESPECT TO UTILITY OF

24 DATA.—
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1 ‘‘(1) IN GENERAL.—To ensure the utility, accu2 racy, and sufficiency of data collected by or for the

3 Agency for the purpose described in section 901(b),

4 the Director shall establish standard methods for de5 veloping and collecting such data, taking into

6 consideration—

7 ‘‘(A) other Federal health data collection

8 standards; and

9 ‘‘(B) the differences between types of

10 health care plans, delivery systems, health care

11 providers, and provider arrangements.

12 ‘‘(2) RELATIONSHIP WITH OTHER DEPARTMENT

13 PROGRAMS.—In any case where standards under

14 paragraph (1) may affect the administration of other

15 programs carried out by the Department of Health

16 and Human Services, including the programs under

17 title XVIII, XIX or XXI of the Social Security Act,

18 or may affect health information that is subject to

19 a standard developed under part C of title XI of the

20 Social Security Act, they shall be in the form of rec21 ommendations to the Secretary for such program.

22 ‘‘(b) STATISTICS AND ANALYSES.—The Director

23 shall—

24 ‘‘(1) take appropriate action to ensure that sta25 tistics and analyses developed under this title are of
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1 high quality, timely, and duly comprehensive, and

2 that the statistics are specific, standardized, and

3 adequately analyzed and indexed; and

4 ‘‘(2) publish, make available, and disseminate

5 such statistics and analyses on as wide a basis as is

6 practicable.

7 ‘‘(c) AUTHORITY REGARDING CERTAIN REQUESTS.—

8 Upon request of a public or private entity, the Director

9 may conduct or support research or analyses otherwise au10 thorized by this title pursuant to arrangements under

11 which such entity will pay the cost of the services provided.

12 Amounts received by the Director under such arrange13 ments shall be available to the Director for obligation until

14 expended.

15 ‘‘SEC. 924. DISSEMINATION OF INFORMATION.

16 ‘‘(a) IN GENERAL.—The Director shall—

17 ‘‘(1) without regard to section 501 of title 44,

18 United States Code, promptly publish, make avail19 able, and otherwise disseminate, in a form under20 standable and on as broad a basis as practicable so

21 as to maximize its use, the results of research, dem22 onstration projects, and evaluations conducted or

23 supported under this title;

24 ‘‘(2) ensure that information disseminated by

25 the Agency is science-based and objective and under-
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1 takes consultation as necessary to assess the appro2 priateness and usefulness of the presentation of in3 formation that is targeted to specific audiences;

4 ‘‘(3) promptly make available to the public data

5 developed in such research, demonstration projects,

6 and evaluations;

7 ‘‘(4) provide, in collaboration with the National

8 Library of Medicine where appropriate, indexing, ab9 stracting, translating, publishing, and other services

10 leading to a more effective and timely dissemination

11 of information on research, demonstration projects,

12 and evaluations with respect to health care to public

13 and private entities and individuals engaged in the

14 improvement of health care delivery and the general

15 public, and undertake programs to develop new or

16 improved methods for making such information

17 available; and

18 ‘‘(5) as appropriate, provide technical assistance

19 to State and local government and health agencies

20 and conduct liaison activities to such agencies to fos21 ter dissemination.

22 ‘‘(b) PROHIBITION AGAINST RESTRICTIONS.—Except

23 as provided in subsection (c), the Director may not restrict

24 the publication or dissemination of data from, or the re25 sults of, projects conducted or supported under this title.
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1 ‘‘(c) LIMITATION ON USE OF CERTAIN INFORMA2 TION.—No information, if an establishment or person sup3 plying the information or described in it is identifiable,

4 obtained in the course of activities undertaken or sup5 ported under this title may be used for any purpose other

6 than the purpose for which it was supplied unless such

7 establishment or person has consented (as determined

8 under regulations of the Director) to its use for such other

9 purpose. Such information may not be published or re10 leased in other form if the person who supplied the infor11 mation or who is described in it is identifiable unless such

12 person has consented (as determined under regulations of

13 the Director) to its publication or release in other form.

14 ‘‘(d) PENALTY.—Any person who violates subsection

15 (c) shall be subject to a civil monetary penalty of not more

16 than $10,000 for each such violation involved. Such pen17 alty shall be imposed and collected in the same manner

18 as civil money penalties under subsection (a) of section

19 1128A of the Social Security Act are imposed and col20 lected.

21 ‘‘SEC. 925. ADDITIONAL PROVISIONS WITH RESPECT TO

22 GRANTS AND CONTRACTS.

23 ‘‘(a) FINANCIAL CONFLICTS OF INTEREST.—With

24 respect to projects for which awards of grants, cooperative
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1 agreements, or contracts are authorized to be made under

2 this title, the Director shall by regulation define—

3 ‘‘(1) the specific circumstances that constitute

4 financial interests in such projects that will, or may

5 be reasonably expected to, create a bias in favor of

6 obtaining results in the projects that are consistent

7 with such interests; and

8 ‘‘(2) the actions that will be taken by the Direc9 tor in response to any such interests identified by

10 the Director.

11 ‘‘(b) REQUIREMENT OF APPLICATION.—The Director

12 may not, with respect to any program under this title au13 thorizing the provision of grants, cooperative agreements,

14 or contracts, provide any such financial assistance unless

15 an application for the assistance is submitted to the Sec16 retary and the application is in such form, is made in such

17 manner, and contains such agreements, assurances, and

18 information as the Director determines to be necessary to

19 carry out the program involved.

20 ‘‘(c) PROVISION OF SUPPLIES AND SERVICES IN

21 LIEU OF FUNDS.—

22 ‘‘(1) IN GENERAL.—Upon the request of an en23 tity receiving a grant, cooperative agreement, or con24 tract under this title, the Secretary may, subject to

25 paragraph (2), provide supplies, equipment, and
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1 services for the purpose of aiding the entity in car2 rying out the project involved and, for such purpose,

3 may detail to the entity any officer or employee of

4 the Department of Health and Human Services.

5 ‘‘(2) CORRESPONDING REDUCTION IN FUNDS.—

6 With respect to a request described in paragraph

7 (1), the Secretary shall reduce the amount of the fi8 nancial assistance involved by an amount equal to

9 the costs of detailing personnel and the fair market

10 value of any supplies, equipment, or services pro11 vided by the Director. The Secretary shall, for the

12 payment of expenses incurred in complying with

13 such request, expend the amounts withheld.

14 ‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS WITH

15 RESPECT TO CONTRACTS.—Contracts may be entered into

16 under this part without regard to sections 3648 and 3709

17 of the Revised Statutes (31 U.S.C. 529 and 41 U.S.C.

18 5).

19 ‘‘SEC. 926. CERTAIN ADMINISTRATIVE AUTHORITIES.

20 ‘‘(a) DEPUTY DIRECTOR AND OTHER OFFICERS AND

21 EMPLOYEES.—

22 ‘‘(1) DEPUTY DIRECTOR.—The Director may

23 appoint a deputy director for the Agency.

24 ‘‘(2) OTHER OFFICERS AND EMPLOYEES.—The

25 Director may appoint and fix the compensation of
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1 such officers and employees as may be necessary to

2 carry out this title. Except as otherwise provided by

3 law, such officers and employees shall be appointed

4 in accordance with the civil service laws and their

5 compensation fixed in accordance with title 5,

6 United States Code.

7 ‘‘(b) FACILITIES.—The Secretary, in carrying out

8 this title—

9 ‘‘(1) may acquire, without regard to the Act of

10 March 3, 1877 (40 U.S.C. 34), by lease or otherwise

11 through the Administrator of General Services,

12 buildings or portions of buildings in the District of

13 Columbia or communities located adjacent to the

14 District of Columbia for use for a period not to ex15 ceed 10 years; and

16 ‘‘(2) may acquire, construct, improve, repair,

17 operate, and maintain laboratory, research, and

18 other necessary facilities and equipment, and such

19 other real or personal property (including patents)

20 as the Secretary deems necessary.

21 ‘‘(c) PROVISION OF FINANCIAL ASSISTANCE.—The

22 Director, in carrying out this title, may make grants to

23 public and nonprofit entities and individuals, and may

24 enter into cooperative agreements or contracts with public

25 and private entities and individuals.
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1 ‘‘(d) UTILIZATION OF CERTAIN PERSONNEL AND RE2 SOURCES.—

3 ‘‘(1) DEPARTMENT OF HEALTH AND HUMAN

4 SERVICES.—The Director, in carrying out this title,

5 may utilize personnel and equipment, facilities, and

6 other physical resources of the Department of

7 Health and Human Services, permit appropriate (as

8 determined by the Secretary) entities and individuals

9 to utilize the physical resources of such Department,

10 and provide technical assistance and advice.

11 ‘‘(2) OTHER AGENCIES.—The Director, in car12 rying out this title, may use, with their consent, the

13 services, equipment, personnel, information, and fa14 cilities of other Federal, State, or local public agen15 cies, or of any foreign government, with or without

16 reimbursement of such agencies.

17 ‘‘(e) CONSULTANTS.—The Secretary, in carrying out

18 this title, may secure, from time to time and for such peri19 ods as the Director deems advisable but in accordance

20 with section 3109 of title 5, United States Code, the as21 sistance and advice of consultants from the United States

22 or abroad.

23 ‘‘(f) EXPERTS.—

24 ‘‘(1) IN GENERAL.—The Secretary may, in car25 rying out this title, obtain the services of not more
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1 than 50 experts or consultants who have appropriate

2 scientific or professional qualifications. Such experts

3 or consultants shall be obtained in accordance with

4 section 3109 of title 5, United States Code, except

5 that the limitation in such section on the duration

6 of service shall not apply.

7 ‘‘(2) TRAVEL EXPENSES.—

8 ‘‘(A) IN GENERAL.—Experts and consult9 ants whose services are obtained under para10 graph (1) shall be paid or reimbursed for their

11 expenses associated with traveling to and from

12 their assignment location in accordance with

13 sections 5724, 5724a(a), 5724a(c), and 5726(c)

14 of title 5, United States Code.

15 ‘‘(B) LIMITATION.—Expenses specified in

16 subparagraph (A) may not be allowed in con17 nection with the assignment of an expert or

18 consultant whose services are obtained under

19 paragraph (1) unless and until the expert

20 agrees in writing to complete the entire period

21 of assignment, or 1 year, whichever is shorter,

22 unless separated or reassigned for reasons that

23 are beyond the control of the expert or consult24 ant and that are acceptable to the Secretary. If

25 the expert or consultant violates the agreement,
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1 the money spent by the United States for the

2 expenses specified in subparagraph (A) is recov3 erable from the expert or consultant as a statu4 tory obligation owed to the United States. The

5 Secretary may waive in whole or in part a right

6 of recovery under this subparagraph.

7 ‘‘(g) VOLUNTARY AND UNCOMPENSATED SERV8 ICES.—The Director, in carrying out this title, may accept

9 voluntary and uncompensated services.

10 ‘‘SEC. 927. FUNDING.

11 ‘‘(a) INTENT.—To ensure that the United States in12 vestment in biomedical research is rapidly translated into

13 improvements in the quality of patient care, there must

14 be a corresponding investment in research on the most ef15 fective clinical and organizational strategies for use of

16 these findings in daily practice. The authorization levels

17 in subsections (b) and (c) provide for a proportionate in18 crease in health care research as the United States invest19 ment in biomedical research increases.

20 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the

21 purpose of carrying out this title, there are authorized to

22 be appropriated $250,000,000 for fiscal year 2000, and

23 such sums as may be necessary for each of the fiscal years

24 2001 through 2005.
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1 ‘‘(c) EVALUATIONS.—In addition to amounts avail2 able pursuant to subsection (b) for carrying out this title,

3 there shall be made available for such purpose, from the

4 amounts made available pursuant to section 241 (relating

5 to evaluations), an amount equal to 40 percent of the max6 imum amount authorized in such section 241 to be made

7 available for a fiscal year.

8 ‘‘SEC. 928. DEFINITIONS.

9 ‘‘In this title:

10 ‘‘(1) ADVISORY COUNCIL.—The term ‘Advisory

11 Council’ means the National Advisory Council on

12 Healthcare Research and Quality established under

13 section 921.

14 ‘‘(2) AGENCY.—The term ‘Agency’ means the

15 Agency for Healthcare Research and Quality.

16 ‘‘(3) DIRECTOR.—The term ‘Director’ means

17 the Director of the Agency for Healthcare Research

18 and Quality.’’.

19 (b) RULES OF CONSTRUCTION.—

20 (1) IN GENERAL.—Section 901(a) of the Public

21 Health Service Act (as added by subsection (a) of

22 this section) applies as a redesignation of the agency

23 that carried out title IX of such Act on the day be24 fore the date of the enactment of this Act, and not

25 as the termination of such agency and the establish-
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1 ment of a different agency. The amendment made

2 by subsection (a) of this section does not affect ap3 pointments of the personnel of such agency who

4 were employed at the agency on the day before such

5 date, including the appointments of members of ad6 visory councils or study sections of the agency who

7 were serving on the day before such date of enact8 ment.

9 (2) REFERENCES.—Any reference in law to the

10 Agency for Health Care Policy and Research is

11 deemed to be a reference to the Agency for

12 Healthcare Research and Quality, and any reference

13 in law to the Administrator for Health Care Policy

14 and Research is deemed to be a reference to the Di15 rector of the Agency for Healthcare Research and

16 Quality.

17 SEC. 3. GRANTS REGARDING UTILIZATION OF PREVENTIVE

18 HEALTH SERVICES.

19 Subpart I of part D of title III of the Public Health

20 Service Act (42 U.S.C. 254b et seq.) is amended by adding

21 at the end the following section:
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1 ‘‘SEC. 330D. CENTERS FOR STRATEGIES ON FACILITATING

2 UTILIZATION OF PREVENTIVE HEALTH SERV3 ICES AMONG VARIOUS POPULATIONS.

4 ‘‘(a) IN GENERAL.—The Secretary, acting through

5 the appropriate agencies of the Public Health Service,

6 shall make grants to public or nonprofit private entities

7 for the establishment and operation of regional centers

8 whose purpose is to develop, evaluate, and disseminate ef9 fective strategies, which utilize quality management meas10 ures, to assist public and private health care programs and

11 providers in the appropriate utilization of preventive

12 health care services by specific populations.

13 ‘‘(b) RESEARCH AND TRAINING.—The activities car14 ried out by a center under subsection (a) may include es15 tablishing programs of research and training with respect

16 to the purpose described in such subsection, including the

17 development of curricula for training individuals in imple18 menting the strategies developed under such subsection.

19 ‘‘(c) PRIORITY REGARDING INFANTS AND CHIL20 DREN.—In carrying out the purpose described in sub21 section (a), the Secretary shall give priority to various

22 populations of infants, young children, and their mothers.

23 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

24 purpose of carrying out this section, there are authorized

25 to be appropriated such sums as may be necessary for

26 each of the fiscal years 2000 through 2004.’’.
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1 SEC. 4. PROGRAM OF PAYMENTS TO CHILDREN’S HOS2 PITALS THAT OPERATE GRADUATE MEDICAL

3 EDUCATION PROGRAMS.

4 Part D of title III of the Public Health Service Act

5 (42 U.S.C. 254b et seq.) is amended by adding at the end

6 the following subpart:

7 ‘‘Subpart IX—Support of Graduate Medical Education

8 Programs in Children’s Hospitals

9 ‘‘SEC. 340E. PROGRAM OF PAYMENTS TO CHILDREN’S HOS10 PITALS THAT OPERATE GRADUATE MEDICAL

11 EDUCATION PROGRAMS.

12 ‘‘(a) PAYMENTS.—The Secretary shall make two pay13 ments under this section to each children’s hospital for

14 each of fiscal years 2000 and 2001, one for the direct ex15 penses and the other for indirect expenses associated with

16 operating approved graduate medical residency training

17 programs.

18 ‘‘(b) AMOUNT OF PAYMENTS.—

19 ‘‘(1) IN GENERAL.—Subject to paragraph (2),

20 the amounts payable under this section to a chil21 dren’s hospital for an approved graduate medical

22 residency training program for a fiscal year are each

23 of the following amounts:

24 ‘‘(A) DIRECT EXPENSE AMOUNT.—The

25 amount determined under subsection (c) for di26 rect expenses associated with operating ap-
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1 proved graduate medical residency training pro2 grams.

3 ‘‘(B) INDIRECT EXPENSE AMOUNT.—The

4 amount determined under subsection (d) for in5 direct expenses associated with the treatment of

6 more severely ill patients and the additional

7 costs relating to teaching residents in such pro8 grams.

9 ‘‘(2) CAPPED AMOUNT.—

10 ‘‘(A) IN GENERAL.—The total of the pay11 ments made to children’s hospitals under para12 graph (1)(A) or paragraph (1)(B) in a fiscal

13 year shall not exceed the funds appropriated

14 under paragraph (1) or (2), respectively, of sub15 section (f) for such payments for that fiscal

16 year.

17 ‘‘(B) PRO RATA REDUCTIONS OF PAY18 MENTS FOR DIRECT EXPENSES.—If the Sec19 retary determines that the amount of funds ap20 propriated under subsection (f)(1) for a fiscal

21 year is insufficient to provide the total amount

22 of payments otherwise due for such periods

23 under paragraph (1)(A), the Secretary shall re24 duce the amounts so payable on a pro rata

25 basis to reflect such shortfall.
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1 ‘‘(c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE

2 MEDICAL EDUCATION.—

3 ‘‘(1) IN GENERAL.—The amount determined

4 under this subsection for payments to a children’s

5 hospital for direct graduate expenses relating to ap6 proved graduate medical residency training pro7 grams for a fiscal year is equal to the product of—

8 ‘‘(A) the updated per resident amount for

9 direct graduate medical education, as deter10 mined under paragraph (2); and

11 ‘‘(B) the average number of full-time

12 equivalent residents in the hospital’s graduate

13 approved medical residency training programs

14 (as determined under section 1886(h)(4) of the

15 Social Security Act during the fiscal year.

16 ‘‘(2) UPDATED PER RESIDENT AMOUNT FOR DI17 RECT GRADUATE MEDICAL EDUCATION.—The up18 dated per resident amount for direct graduate med19 ical education for a hospital for a fiscal year is an

20 amount determined as follows:

21 ‘‘(A) DETERMINATION OF HOSPITAL SIN22 GLE PER RESIDENT AMOUNT.—The Secretary

23 shall compute for each hospital operating an

24 approved graduate medical education program

25 (regardless of whether or not it is a children’s
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1 hospital) a single per resident amount equal to

2 the average (weighted by number of full-time

3 equivalent residents) of the primary care per

4 resident amount and the non-primary care per

5 resident amount computed under section

6 1886(h)(2) of the Social Security Act for cost

7 reporting periods ending during fiscal year

8 1997.

9 ‘‘(B) DETERMINATION OF WAGE AND NON10 WAGE-RELATED PROPORTION OF THE SINGLE

11 PER RESIDENT AMOUNT.—The Secretary shall

12 estimate the average proportion of the single

13 per resident amounts computed under subpara14 graph (A) that is attributable to wages and

15 wage-related costs.

16 ‘‘(C) STANDARDIZING PER RESIDENT

17 AMOUNTS.—The Secretary shall establish a

18 standardized per resident amount for each such

19 hospital—

20 ‘‘(i) by dividing the single per resident

21 amount computed under subparagraph (A)

22 into a wage-related portion and a non23 wage-related portion by applying the pro24 portion determined under subparagraph

25 (B);
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1 ‘‘(ii) by dividing the wage-related por2 tion by the factor applied under section

3 1886(d)(3)(E) of the Social Security Act

4 for discharges occurring during fiscal year

5 1999 for the hospital’s area; and

6 ‘‘(iii) by adding the non-wage-related

7 portion to the amount computed under

8 clause (ii).

9 ‘‘(D) DETERMINATION OF NATIONAL AV10 ERAGE.—The Secretary shall compute a na11 tional average per resident amount equal to the

12 average of the standardized per resident

13 amounts computed under subparagraph (C) for

14 such hospitals, with the amount for each hos15 pital weighted by the average number of full16 time equivalent residents at such hospital.

17 ‘‘(E) APPLICATION TO INDIVIDUAL HOS18 PITALS.—The Secretary shall compute for each

19 such hospital that is a children’s hospital a per

20 resident amount—

21 ‘‘(i) by dividing the national average

22 per resident amount computed under sub23 paragraph (D) into a wage-related portion

24 and a non-wage-related portion by applying
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1 the proportion determined under subpara2 graph (B);

3 ‘‘(ii) by multiplying the wage-related

4 portion by the factor described in subpara5 graph (C)(ii) for the hospital’s area; and

6 ‘‘(iii) by adding the non-wage-related

7 portion to the amount computed under

8 clause (ii).

9 ‘‘(F) UPDATING RATE.—The Secretary

10 shall update such per resident amount for each

11 such children’s hospital by the estimated per12 centage increase in the consumer price index for

13 all urban consumers during the period begin14 ning October 1997 and ending with the mid15 point of the hospital’s cost reporting period that

16 begins during fiscal year 2000.

17 ‘‘(d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL

18 EDUCATION.—

19 ‘‘(1) IN GENERAL.—The amount determined

20 under this subsection for payments to a children’s

21 hospital for indirect expenses associated with the

22 treatment of more severely ill patients and the addi23 tional costs related to the teaching of residents for

24 a fiscal year is equal to an amount determined ap25 propriate by the Secretary.
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1 ‘‘(2) FACTORS.—In determining the amount

2 under paragraph (1), the Secretary shall—

3 ‘‘(A) take into account variations in case

4 mix among children’s hospitals and the number

5 of full-time equivalent residents in the hospitals’

6 approved graduate medical residency training

7 programs; and

8 ‘‘(B) assure that the aggregate of the pay9 ments for indirect expenses associated with the

10 treatment of more severely ill patients and the

11 additional costs related to the teaching of resi12 dents under this section in a fiscal year are

13 equal to the amount appropriated for such ex14 penses for the fiscal year involved under sub15 section (f)(2).

16 ‘‘(e) MAKING OF PAYMENTS.—

17 ‘‘(1) INTERIM PAYMENTS.—The Secretary shall

18 determine, before the beginning of each fiscal year

19 involved for which payments may be made for a hos20 pital under this section, the amounts of the pay21 ments for direct graduate medical education and in22 direct medical education for such fiscal year and

23 shall (subject to paragraph (2)) make the payments

24 of such amounts in 26 equal interim installments

25 during such period.
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1 ‘‘(2) WITHHOLDING.—The Secretary shall with2 hold up to 25 percent from each interim installment

3 for direct graduate medical education paid under

4 paragraph (1).

5 ‘‘(3) RECONCILIATION.—At the end of each fis6 cal year for which payments may be made under this

7 section, the hospital shall submit to the Secretary

8 such information as the Secretary determines to be

9 necessary to determine the percent (if any) of the

10 total amount withheld under paragraph (2) that is

11 due under this section for the hospital for the fiscal

12 year. Based on such determination, the Secretary

13 shall recoup any overpayments made, or pay any

14 balance due. The amount so determined shall be

15 considered a final intermediary determination for

16 purposes of applying section 1878 of the Social Se17 curity Act and shall be subject to review under that

18 section in the same manner as the amount of pay19 ment under section 1886(d) of such Act is subject

20 to review under such section.

21 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—

22 ‘‘(1) DIRECT GRADUATE MEDICAL EDU23 CATION.—

24 ‘‘(A) IN GENERAL.—There are hereby au25 thorized to be appropriated, out of any money
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1 in the Treasury not otherwise appropriated, for

2 payments under subsection (b)(1)(A)—

3 ‘‘(i) for fiscal year 2000, $90,000,000;

4 and

5 ‘‘(ii) for fiscal year 2001,

6 $95,000,000.

7 ‘‘(B) CARRYOVER OF EXCESS.—The

8 amounts appropriated under subparagraph (A)

9 for fiscal year 2000 shall remain available for

10 obligation through the end of fiscal year 2001.

11 ‘‘(2) INDIRECT MEDICAL EDUCATION.—There

12 are hereby authorized to be appropriated, out of any

13 money in the Treasury not otherwise appropriated,

14 for payments under subsection (b)(1)(A)—

15 ‘‘(A) for fiscal year 2000, $190,000,000;

16 and

17 ‘‘(B) for fiscal year 2001, $190,000,000.

18 ‘‘(g) DEFINITIONS.—In this section:

19 ‘‘(1) APPROVED GRADUATE MEDICAL RESI20 DENCY TRAINING PROGRAM.—The term ‘approved

21 graduate medical residency training program’ has

22 the meaning given the term ‘approved medical resi23 dency training program’ in section 1886(h)(5)(A) of

24 the Social Security Act.
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1 ‘‘(2) CHILDREN’S HOSPITAL.—The term ‘chil2 dren’s hospital’ means a hospital described in section

3 1886(d)(1)(B)(iii) of the Social Security Act.

4 ‘‘(3) DIRECT GRADUATE MEDICAL EDUCATION

5 COSTS.—The term ‘direct graduate medical edu6 cation costs’ has the meaning given such term in

7 section 1886(h)(5)(C) of the Social Security Act.’’.

8 SEC. 5. STUDY REGARDING SHORTAGES OF LICENSED

9 PHARMACISTS.

10 (a) IN GENERAL.—The Secretary of Health and

11 Human Services (in this section referred to as the ‘‘Sec12 retary’’), acting through the appropriate agencies of the

13 Public Health Service, shall conduct a study to determine

14 whether and to what extent there is a shortage of licensed

15 pharmacists. In carrying out the study, the Secretary shall

16 seek the comments of appropriate public and private enti17 ties regarding any such shortage.

18 (b) REPORT TO CONGRESS.—Not later than 1 year

19 after the date of the enactment of this Act, the Secretary

20 shall complete the study under subsection (a) and submit

21 to the Congress a report that describes the findings made

22 through the study and that contains a summary of the

23 comments received by the Secretary pursuant to such sub24 section.
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1 SEC. 6. REPORT ON TELEMEDICINE.

2 Not later than January 10, 2001, the Secretary of

3 Health and Human Services shall submit to the Congress

4 a report that—

5 (1) identifies any factors that inhibit the expan6 sion and accessibility of telemedicine services, includ7 ing factors relating to telemedicine networks;

8 (2) identifies any factors that, in addition to

9 geographical isolation, should be used to determine

10 which patients need or require access to telemedicine

11 care;

12 (3) determines the extent to which—

13 (A) patients receiving telemedicine service

14 have benefited from the services, and are satis15 fied with the treatment received pursuant to the

16 services; and

17 (B) the medical outcomes for such patients

18 would have differed if telemedicine services had

19 not been available to the patients;

20 (4) determines the extent to which physicians

21 involved with telemedicine services have been satis22 fied with the medical aspects of the services;

23 (5) determines the extent to which primary care

24 physicians are enhancing their medical knowledge

25 and experience through the interaction with special26 ists provided by telemedicine consultations; and
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1 (6) identifies legal and medical issues relating

2 to State licensing of health professionals that are

3 presented by telemedicine services, and provides any

4 recommendations of the Secretary for responding to

5 such issues.

6 SEC. 7. CERTAIN TECHNOLOGIES AND PRACTICES REGARD7 ING SURVIVAL RATES FOR CARDIAC ARREST.

8 The Secretary of Health and Human Services shall,

9 in consultation with the Administrator of the General

10 Services Administration and other appropriate public and

11 private entities, develop recommendations regarding the

12 placement of automatic external defibrillators in Federal

13 buildings as a means of improving the survival rates of

14 individuals who experience cardiac arrest in such build15 ings, including recommendations on training, mainte16 nance, and medical oversight, and on coordinating with

17 the system for emergency medical services.

Passed the Senate November 3, 1999.

Attest:

Secretary.
106TH CONGRESS

1ST SESSION S. 580

AN ACT

To amend title IX of the Public Health Service Act

to revise and extend the Agency for HealthcarePolicy and Research.