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Spends ~ The Omnibus Budget koconcHiabon Act of 1939 Pubbc ~ 101-~ He Omnibus Budgel Re=ncO~l~n ~1 of 1989, amended He P~bc Realm Seance and Social ~cuIiV ~G 1O create 1~ MODE HI Health Ore Poll and Search. The ~: ~ an ^=rpl Tom 1bal legislation. 107

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108 CLINICAL PRACTICE GUIDELINES SEC 6103. ESTABLISHMENT OF AG== FOR H=L~ Cat POLICY AD RESEARCIL (a) ~ GENERAL The Public Health Service Act (42 U.S.C. 201 et seq.) ~ amended by inserting after title VIII the following new title: 'MULE ~-AGENCY FOR HEALTH CARE POLICY AND RESEARCH PART A EsTAsus~Errr AND GENDER DOTES "SEC 901. ESTABLISHMENT. "(a) ~ GENERAL There ~ established within the Service an agency to be known as the Agency for Health Care Policy and Research. "(b) PURPOSE. The pure of the Agency is to enhance the quality, appropriateness, and effectiveness of health care services and access to such services, through the establishment of a broad base of scientific research and through the promotion of improver meets in clinical practice and in the org~ni~-~tion, financing, and delivery of health care seances. "(C) APPO~ENr OF AD~N~RA-TOR. There shall be at the head of the Agency ~ official to be known as the Administrator for Health Care Policy and Research. I"ne Administrator shall be am pointed by the Secreta~r. The Secretary, acting through the Administrator, shall cany out the authorities and duties established in this title. "SEA 902. GENERAL AUl1IORl'IIES AND DUTIES. "(a) IN GENERAL-In caring out section 901(b), the Adminis- trator shall conduct and support research, demonstration projects evaluations, training guideline development, and the dissemination of information, on health care servicm and on systems for the delivery of such seances, including activities with respect to "(1) the effectiveness, efficiency, and quality of health care seances "(2) subject to subsection (d), the outcomes of health care services and procedure "(3) clinical practice including primary care and practice oriented research "(4) health care technologies, facilities, and equipment "(5) health care costs, productivity, and market forces "(6) health promotion and disease Drevention "(7) health statistics Ad epidemiology, and "(8) medical liability. 42 USC 299. 42 USC 299a.

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APPENDIX A 103 STAT. 2190 109 PUBLIC LAW 101-239 DEC. 19, 1989 (b) REQUIREMENTS WITH RESPEC r TO RURAL AREAS AND UNDER_ SERVED POPULATIONS. In carrying out subsection (a), the Adminis- trator shall undertake and support research, demonstration projects, and evaluations with respect tom "(1) the delivery of health care services in rural areas (includ- in~ frontier areas), and '(2) the health of low-income groups, minority groups, and the elderly. "(C) ~IULTIDISCIP~NARY CENTERS.-The Administrator may pro- vide financial assistance to public or nonprofit private entities for meeting the costs of planning and establishing new centers, and operating existing and new centers, for multidisciplinary health services research, demonstration projects, evaluations, training, policy analysis, and demonstrations respecting the matters referred to In subsection (b). (d) RELATION TO CERTAIN AUTHORITIES REGARDING SOCIAL SECU Rem. Activities authorized in this section may include, and shall be appropriately coordinated with, experiments, demonstration projects, and other related activities authorized by the Social Secu- r ty Act and the Social Security Amendments of 1967. Activities under subsection (aX2) 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. 42 USC 299a-1. "SEC. 903. DISSEMINATION. Public information. State and local governments. "(a) IN GENERAL. The Administrator shall- "(1) promptly publish, make available, and otherwise dissemi- nate, 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 and the guidelines, standards, and review cri- teria developed under this title "(2) promptly make available to the public data developed in such research, demonstration projects, and evaluations "(3) provide indexing, abstracting, translating, publishing, and other services leading to a more effective and timely dissemination of info. :`lation on research, demonstration projects, and evaluations with respect to health care to public and private entities and individuals engaged in the improve ment of health care delivery and the general public, and under- take 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) pRoHIBmow AGAINST RES~ICrIONS. Except as provided in subsection (c), the Administrator 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 INS ORMATION. No informa- tion, 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 Secretary) to its use for such other purpose. Such information may not be published or released in other form if the

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110 PUBLIC LAW 101-239 DEC. 19, 1989 person who supplied the information or who is described in it is identifiable unless such person has consented (as determined under regulations of the Secretary) to its publication or release in other form. ' (d) CERTAIN AGENCY AGREEMENT. The Administrator and the Director of the National Library of Medicine shall enter into an agreement providing for the implementation of subsection (aX31. CLINICAL PRACTICE GUIDE' [NES 103 STAT. 2191 "SEC. 904. HEALTH CARE TECHNOLOGY AND TECHNOLOGY ASSESSMENT. 42 USC 299a-2. "(a) IN GENES-In carding out Action 901(b), the Adminis- trator shall promote the development and application of appropriate health care technology assessments "(1) by identifying needs in, and establishing priorities for, the assessment of specific health care technologies "(2) by developing and evaluating criteria and methodologies for health care technology augment "(3) by conducting and supporting research on the develop ment and diffusion of health care technology "(4) by conducting and supporting research on assessment methodologies, and "(5) by promoting educations trading, and technical assist- ~nce in the use of health core technology assessment methodolo- gie8 and results. "I SP=~"C Add. "(1) IN GENERAL Il] Carrymg out section 901(b), the Admire trator shall conduct and support specific assessments of health care technologies (2) CONSIDERATION OF cEaT~N FACTORS. In car~yir~g out paragraph (1), the Administrator shall consider the safety, eff~- cacy, and effectiveness, and, as appropriate, the cost-effective- ne", legal, social, Ad ethical implications, and appropriate uses of such technologiie8, including consideration of geographic factory "(C) INPORMATION by. "(1) ~ GENEELU" There shall be established at the National Establishment. Library of Medicine an information center on health care tech nologies and health care technology Comment. "(2) IN~GEwc~r AGREEMENT. The Administrator and the Director of the National Library of Medicine shall enter into an agreement providing for the implementation of paragraph (1). (d) RECOMMENDATIONS WITH RE 3PEcr TO HEALS CARE TECH NOLOGY.- "(1) Led GENERAL The Administrator shall make rec- ommendations to the Secretary with respect to whether specific health care technologies should be reimbursable under federally financed health programs, including recommendations with re specs to any conditions and requirements under which any such reimbursements should be made. (2) CONSIDER^=ON OF c=TA~N FAC7rORS.-In making rec- ommendatione respecting health care technologies, the Adnamiatrator shall consider the safety, efficacy, and effective ne - , and, as appropriate, the co~effectivene" Ed appropriate uses of such technologies. (3) CONSULTA=ONS.-In carrying out this subsection, the Administrator shall cooperate and consult with the Director of the National Institutes of Health, the Commissioner of Food

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APPENDIX A 103 STAT. 2192 111 PUBLIC LAW 101-239 DEC. 19, 1989 and Drugs, and the heads of any other interested Federal department or agency. PART B-FORUM FOR QUAD AND EFFECTIVENESS IN HEALTH CARE 42 USC 299b. "SEC. 911. ESTABLISHMENT OF OFFICE. "There is established within the Agency an office to be known as the Office of the Forum for Quality and Effectiveness in Health Care. The office shall be headed by a director, who shall be am pointed by the Administrator. 42 USC 299b- 1. 'SEC. 912. DUTIES. (a) ESTAB~SHMEN r OF FORUM PROGRAM. The Administrator acting through the Director, shall establish a program to be known as the Forum for Quality and Effectiveness in Health Care. For the purpose of promoting the quality, appropriateness, and effectiveness of health care, the Director, using the process set forth in section 913, shall arrange for the development and periodic review and updating of "(1) clinically relevant guidelines that may be used by physi- cians, educators, and stealth care practitioners to assist in deter- mining how diseases, disorders and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically, and "(2) standards of quality, performance measures, and medical review criteria through which health care providers and other appropriate entities may assess or review the provision of health care and assure the quality of such care. "(b) CERTAIN REQUIREMENTS.~UideiineS, standards, performance measures, and review criteria under subsection (a) shall "(1) be based on the best available research and professional judgment regarding the effectiveness and appropriateness of health care services and procedures "(2) be presented in formats appropriate for use by physicians, health care practitioners, providers, medical educators, and medical review organizations and in formats appropriate for use by consumers of health care, and "(3) include treatment-specific or condition-specif~c practice guidelines for clinical treatments and conditions in forms apprise priate for use in clinical practice, for use in educational pro- grams, and for use in reviewing quality and appropriateness of medical care. "(C) AUTHORm FOR cONTRAcTs.-In carrying out this part, the Director may enter into contracts with public or nonprofit private entities. (d) DATE ()ERTAIN FOR INITIAL GUIDELINES AND STANDARDS. The Administrator, by not later than January 1, 1991, shall assure the development of an initial set of guidelines, standards, performance measures, and review criteria under subsection (a) that includes not less than 3 clinical treatments or conditions described in section 1142(a)(3) of the Social Security Act. (e) RELATIONSHIP WITH MEDICARE PROGRAM.- To assure an appropriate reflection of the needs and priorities of the program under title XVIII of the Social Security Act, activities under this part that affect such program shall be conducted consistent with section 1142 of such Act.

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112 CLINICAL PRACTICE GUIDELINES PUBLIC LAW 101-239 DEC. 19, 1989 103 STAT 2193 "SEC. 913. PROCESS FOR DEVELOPMENT OF GUIDELINES AND STAND- 42 UP 299b-2. AROS. (a) DEVELOPMENT THROUGH CONTACTS AND PANEI5.-The Direc tor shall- "(1) enter into contracts with public and nonprofit priorate entities for the purpose of developing and periodically reviewing and updating the guidelines, standards, performance measures and review criteria descnbed in section 912(a), and "(2) convene panels of appropriately qualified experts (includ ing practicing physicians with appropriate expertise) and health care consumers for the pure of "(A) developing and periodically reviewing and updating the Sidelines, standards, performance measures, and review criteria described in section 912(a), and "(B) rehang the guidelines, standards, performance measures, and renew criteria developed under contracts under paragraph (1). "(b) Au~oR~ FOR ADDmoN~ Pats. The Director may con vene panels of appropriately qualified experts (including practicing physicians with appropriate expertise) and health care consumers for the pure of "(1) developing the standards and criteria described in Action 914(b); and "(2) providing advice to the Administrator and the Director with respect to any other activities carried out under this part or under section 902(aX2). "(C) SELECDOH OF PANT MEMB~. In selecting individ',al~ to senre on panels convened under this section, the Director shall consult with a broad range of Stewed indi~nd~ls and organ~- t~ons, including org~tions representing physicians in the general practice of medicine Ad orga~i7-tions representing physic in specialties Ad subspecialties pertinent to the Purposes of the panel involved. The Director shall #ek to appoint phym~n~ reflecting a variety of practice settings. USED 914. ~oDmONAL REQUIaEMEN~L "(a) PROGRAM AGENDA.- "(1) LN Got-The Administrator shall provide for an agenda for the development of the guidelines, standards, performance menus es, and review cutena deprived ~ section 912(a), including "(A) with respect to the guidelines, identifying specific di - R - s, disorders, and other health conditions for which the guidelines are to be developed and those that are to be given priority in the development of the guidelines; and "(B) with respect to the ~dards, performance mew ures, and renew criteria, identifying specific expects of health care for which the ~dards, performance mean ures, and review criteria are to be developed and those that are to be "liven priority in the development of the stand ards, performance measures, and review criteria. (2) CONSIDERATION OF CBT~ FACTO" ~ ESTABLISHING PRIORITIES.- "(A) Factors considered by the At7mini~trator in establishing priorities for purposes of paragraph (1) shall include consideration of the extent to which the guidelines, 42 USC 299~3.

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APPENDIX A 103 STAT. 2194 113 PUBLIC LA\V 101-239 DEC. 19, 1989 standards, performance measures, and review criteria in- volved can be embed "(i) to improve methods of prevention, diagnc-s~s treatment, and clinical management for the benefit of a significant number of individuals; "(ii) to reduce clinically significant variations among physicians in the particular services and procedures utilized in making diagnoses and providing treatments; and "(iii) to reduce clinically significant variations in the outcomes of health care services and procedures, "(B) In providing for the agenda required in paragraph `1), including the priorities, the Administrator shall consult with the Administrator of the Health Care Financing Administration and otherwise act consistent with section 1142(bX3) of the Social Security Act. (b) STANDARDS AND CRITERIA. (1) PROCESS FOR DEVELOPAIE~r, REVIEW, AND UPDATING. Ike Director shall establish standards .s;~d criteria to be utilized by the recipients of contracts under section 913, and by the expert panels convened under such section, with respect to the develop ment and periodic review and updating of the guidelines, stand- ards, performance measures, and review criteria described in section 912(a). "(2) AWARD OF CON rRACrS. The Director shall establish standards and criteria to be utilized for the purpose of ens unug that contracts entered into for the development or periodic review or updating of the guidelines, standards, performance measures, and review criteria described in section 912(a) will be entered into only with appropriately qualified entities (3) CERTAIN REQUIRF.M~NTS FOR STANDARDS AND CRIT~. The Mrec~r shall ensure that the standards and criteria estate fished under paragraphs (l) and (2) specify that "(A) appropriate consultations with interned individ- uale and organizations are to be conducted in the develop- ment of the guidelines, standards, performance measures, Ad review criteria described in section 912(a), and "(B) such development may be accomplished through the adoption, with or without modification, of guidelines, stand- ards, performance measures, and review criteria that "(i) meet the requirements of this part, and "(ii) are developed by entities independently of the program established in this part. (4) IMPROVE OF sr~wDARDs AND craters. Ike Direc- tor shall conduct and support research with respect to impro~r- ing the standards and criteria developed under this subsection. "(C) D~NA=ON. The Director shall promote and support the dissemination of the guidelines, standards, performance measures and review criteria described in section 912(a). Such dissemination shall be carried out through organizations representing health care providers, orgpni~tion~ representing health care consumers, peer retried organizations, accrediting bodies, and other appropriate enti- t~es. "(d) PILar TEsT=G. The Director may conduct or support pilot testing of the guidelines, standards, performance measures, and review criteria developed under section 912(a). Any such pilot teed

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114 PUBLIC LAW 101-239 DEC. 19, 1989 ing may be conducted prior to, or concurrently with, their dissemi- nation under subsection (c). "(e) EVALUATIONS. The Director shall conduct and support evaluations of the extent to which the guidelines, standards, performance standards, and review criteria developed under section 912 have had an effect on the clinical practice of medicine. (f) RECo~ENDAT~ONs TO ADMINISTRATOR. The Director shall make recommendation to the Administrator on activities that should be carried out under section 902(~)(2) and under section 1142 of the Social Security Act, including recommendations of particular research projects that should be carried out with ' respect to- "(1) evaluating the outcomes of health care services and procedures; "(2) developing the standards and criteria required in subsec- tion (b), and "(3) promoting the utilization of the Sidelines, standards performance standards, and review criteria developed under section 912(a).". (b) OUTCOMES OF HEALTH CARE SERVICES AND PROCEDURES. (1) Esr~smsHMENr OF PROGRAM OF RESEARCH.-Part A of title XI of the Social Security Act (42 U.S.C. 1301 et seq.) is amended by adding at the end the following new section: RESEARCH ON OUTCOME OF HEALTn CARE SERVICES AND PROCEDURES SE:C. 1142. (a) EsT~susHMENr OF PROGRAM.- CLINICAL PRACTICE GUIDELINES 103 STAT. 2195 42 USC "(1) ~ GENERA T'ne Secretary, acting through the Adminis 1320~12 trator for Health Care Policy and Research, shall "(A) conduct and support research with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically, and "(B) assure that the needs and priorities of the program under title XVIII are app.opmately reflected in the develop ment and periodic renew and updating (through the proc ess set forth in section 913 of the Public Health Seance Act) of treatment~pecific or condition~pecific practice guides lines for clinical treatments and conditions in forms appro priate for use in clinical practice for use in educational programs, and for use in reviewing quality and appropriate ness of medical care. (2) EVALUATIONS OF ALTERNATE E SERVICES AND PROCE DUR=. In tying out paragraph (1), the Secretary shall con duct or support evaluations of the comparative effects, on health and functional capacity, of alternative services and procedures utilized in preventing, diagnosing, treating, and clinically managing disease, disorders, and other health condi tons. (3) INmAL GUIDES. "(A) In carrying out paragraph (1)(B3 of this subsection and section 912(d) of the Public Health Service Act, the Secretary shall, by not later than January 1, 1991, assure the development of an initial set of the guidelines specified in paragraph (1)(B) that shall include not less than 3 clini cal treatments or conditions that-

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APPENDIX 115 103 STAT. 2196 PUBLIC LAW 101-239 DEC. 19, 1989 "(i)(I) account for a significant portion of expendi tures under title XVIII, and "(II) have a significant variation in the frequency or the type of treatment provided, or Reports. "(it) otherwise meet the needs and priorities of the program under title XVIII, as set forth under subsec tion (bX3). "(BXi) The Secretary shall provide for the use of guide lines developed under subparagrah (A) to improve the qual ity, effectiveness, and appropriateness of care provided under title XVIII. The Secretary shall determine the impact of such use on the quality, appropriateness, effectiveness and cost of medical care provided under such title and shall report to the Congress on such determination by not later than January 1, 1993. "(ii) For the purpose of carrying out clause (i), the Sec retary shall expend, from the amounts specified in clause (iii), $1,000,000 for fiscal year 1990 and $1,500,000 for each of the fiscal years 1991 and 1992. "(iii) For each focal year, for purposes of expenditures required in clause (dim lo) ^IORmB. '`(I) 60 percent of an amount equal to the expenditure involved is appropriated from the Federal Hospital Insurance Trust Fund (established under section 1817); and "(II) 40 percent of an amount equal to the expendi- ture involved is appropriated from the Federal Supple- mentary Medical Insurance Trust Fund (established under section 1841). "(1) IN GENERAL. The Secretary shall establish priorities with respect to the diseases, disorders, and other health condi- tions for which research and evaluations are to be conducted or supported under subsection (a). In establishing such priorities the Secretary shall, with respect to a disease, disorder, or other health condition, consider the extent to which "(A) improved methods of prevention, diagnosis, treat- ment, and clinical management can benefit a significant number of individuals "(B) there is significant variation among physicians in the particular services and procedures utilized in making diagnoses and providing treatments or there is significant variation in the outcomes of health care services or Procter cures due to different patterns of diagnosis or treatment; "(C) the services and procedures utilized for diagnosis and treatment result in relatively substantial expenditures, and "(D) the data necessary for such evaluations are readily available or can readily be developed. (2) PRELIMINARY ~SSEssMEN Is.-For the purpose of establish- ing priorities under paragraph (1), the Secretary may, with respect to services and procedures utilized in preventing, di- agnosing, treating, and clinically man aging diseases, disorders and other health conditions, conduct or support assessments of the extent to which- "(A) rates of utilization vary among similar populations for particular diseases, disorders, and other health condi- tions;

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116 PUBLIC LAW 101-239 DEC. 19, 1989 "(B) uncertainties exist on the effect of utilizing a particu- lar service or procedure, or "(C) inappropriate services and procedures are provided. ' (3) RELATIONSHIP WI]n MEDICARE PROGRAM.- In establishing priorities under paragraph (1) for research and evaluation, and under section 914(a) of the Public Health Service Act for the agenda under such section, the Secretary shall assure that such priorities appropriately reflect the needs and priorities of the progr~rr~ under title XVIII, as set forth by the Administrator of the Health Care Financing Administration. (cj M=HoDo~oG~Es AND CRITERIA F OR EVALUATIONS.- For the purpose of facilitating research under subsection (a), the Secretary shall "(1) conduct and support research with respect to the Improvement of methodologies and criteria utilized in conduct- ing research with respect to outcomes of health care services and procedures "(2) conduct and support reviews and evaluations of existing research findings with respect to such treatment or conditions "(3) conduct and support reviews and evaluations of the exist- ing methodologies that use large data bases in conducting such research and shall develop new research methodologies, includ- ing data-based methods of advancing knowledge and methodolo- gies that measure clinical and functional status of patients with respect to such research; CLINICAL PRACTICE GUIDELINES 103 STAT. 2197 - , "(4) pronde grants and contracts to research centers, and Grants. contracts to other entities, to conduct such research on such Contracts treatment or conditions, including research on the appropriate use of prescription drugs "'5) conduct and support research and demonstrations on the use of claims data and data on clinical and functional status of patients in determining the outcomes, effectiveness, and appro priateness of such treatment, and "(6) conduct and support supplementation of eating data bases, including the collection of new information, to enhance data bases for research purposes, and the design and develop ment of new data bases that would be used in outcomes and effectiveness research. (d) STANDARDS FOR DATA BASES. In carrying out this section, the Secretary shall develop- "(1) uniform definitions of data to be collected and used in describing a patient's clinical and functional status "(2) common reporting formats arid linkages for such data; and "(3) standards to assure the security, confidentiality, ac curacy, and appropriate maintenance of such data. (e) DISSEMINATION OF RESEARCH FINDINGS AND GUIDELINES. Education. "(1) Ill GENERA. The Secretary shall provide for the dissemi nation of the findings of research and the guidelines described in subsection (a), and for the education of providers and others in the application of such research findings and guidelines. "(2) COOPERATIVE EDUCATIONAL ACrIVrrIES. In disseminating findings and guidelines under paragraph (1), and in providing for education under such paragraph, the Secretary shall work with professional associations, medical specialty and sum specialty organizations, and other relevant groups to identify sued implement effective means to educate physicians, other

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APPENDIX A 103 STAT. 2198 42 USC 1320~12 note. 117 PUBLIC LAW 101-239-DEC. 19, 1989 providers, consumers, and others in using such findings and guidelines, including training for physician managers within prodder organizations. "(f) EVALUATIONS. The Secretary 8hA11 conduct and support evaluations of the activities carried out under this section to deter- mine the extent to which such activities have had an effect on the practices of physicians in prodding medical treatment, the delivery of health care, and the outcomes of health care services and proce- dures. (g) RESEARCH WrrH RESPECT TO DISSEMINATION. The Secretary may conduct or support research with respect to improving methods of disseminating information on the effectiveness and appropriate ness of health care services and procedures. "(h) REPORT TO CONGRESS. Not later than February 1 of each of the years 1991 and 1992, and of each second year thereafter, the Secretary shall report to the Congress on the progress of the activi- ties under this section during the preceding fiscal year (or preceding 2 fiscal years, as appropriate), including the impact of such activities on medical care (particularly medical care for individuals receiving benefits under title XVIII). (i) AUTHORIZATION OF APPROPRIATIONS.- "(1) IN GENERAL There are authorized to be appropriated to carry out this section "(A) $50,000,000 for f~1 year 1990; "(B) $75,000,000 for focal year 1991; "(A $110,000,000 for fecal year 1992 "(D) $148,000,000 for focal year 1993; and "(E) $185,000,000 for focal year 1994. (2) SPECIF1CA=ONS. For the purpose of carrying out this section, for each of the fiscal years 1990 through 1992 an amount equal to two-thirds of the amounts authorized to be appropriated under paragraph (1), and for each of the fiscal years 1993 and 1994 an amount equal to 70 percent of such amounts, are to be appropriated in the following proportions from the following trust funds: "(A) 60 percent from the Federal Hospital Insurance Trust Fund (established under section 1817). "(B) 40 percent from the Federal Supplementary Medical Insurance Trust F und (established under section 1841). (3) ALLOCATIONS. "(A) For each fiscal Year, of the amounts transferred or otherwise appropriated to carry out this section, the Sec- retary shall reserve appropriate mounts for each of the purposes specified in clauses (i) through (iv) of subpara- graph (B). "(B) The purposes referred to in subparagraph (A) are- "(i) the development of guidelines, standards performance measures, and renew criteria; "(ii) research and evaluation "(iii) data-base standards and development, and "(iv) education and information dissemination.". (2) REPORT ON MNICAGE OF PUBLIC AND PRrVATE RESEARCH RELATED DATA. Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall report to the Congress on the feasibility of linking research-related data described in section 1142(d) of the Social Security Act (as added by paragraph (1) of this subsection) with

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118 PUBLIC LAW 101-239 DEC. 19, 1989 similar data collected or maintained by non-Federal entities and by Federal agencies other then the Department of Health and Human Services (including the Departments of Defense and Veterans Affairs and the Office of Personnel Management). (3) TECHNICAL AND CONFORh~ING PROVISIONS (A) Effective for fiscal years beginning after fiscal year 1990 subsection (c) of section 1875 of the Social Security Act (42 0.S.C. 139511) is repealed. (B) Section 1862(aXl)(E) of the Social Security Act (42 U.S.C. 1395y(aXl)(E)) is emended by striking "section 1875(c)" and inserting "section 1142". (C) ADDmonA~ Au rnoRrrn:s AND D[mB WrrH RBPECr TO AGENCY FOR HEALTH CARE POLICY AND RESEARCH.- Title IX of the Public Health Service Act, as added by subsection (a) of this section, is Unended by adding at the end the following new part: _ _ ~ ~ , %, i_ . PART C GENERAL PROVISIONS CLINICAL PRACTICE GUIDELINES 103 STAT. 2199 "SEC. 921. ADVISORY COUNCIL FOR HEALS CARE POLICY, RESEARCH, 42 USC 299c. AND EVALUATION. "(a) EsT`susHMEw~r There is established an advisory council to be know as the National Advisory Council for Health Care Policy Research, and Evaluation. "(b) DUTIES. "(1) IN GENERAL. The Council shall advise the Secretary and the Administrator with respect to activities to carry out the purpose of the Agency under section 901(b) ' (2) CERTAIN REcoMMENDAT~ONS.-Activities of the Council under paragraph (1) shall include making recommendations to the Administrator regarding priorities for a national agenda and strategy for "(A) the conduct of research, demonstration projects, and evaluations with respect to health care, including clinical practice and primary care "(B) the development and application of appropriate health care technology assessments; "(C) the development and periodic review and updating of guidelines for clinical practice, standards of quality performance measures, and medical renew criteria with respect to health care, and "(D) the conduct of research on outcomes of health care services and procedures. (C) ME3IBERSHIP. "(1) IN GENERAL. The Council shall, in accordance with this subsection, be composed of appointed members and ex officio members. All members of the Council shall be voting members other than officials designated under paragraph (3XB) as ex officio members of the Council. "(2) AppoINrED MEMBERS. The Secretary shall appoint to the Council 17 appropriately qualified representatives of the public who are not officers or employees of the United States. The Secretary shall ensure that the appointed members of the Coun c~l, as a group, are representative of professions and entities concerned with, or affected by, activities under this title and

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APPENDIX A 103 STAT. 2200 119 PUBLIC LAW 101-239 DEC. 19, 1989 under section 1142 of the Social Security Act. Of such mem- bers "(A) 8 shall be individuals distinguished in the conduct of research, demonstration projects, and evaluations with ret specs to health care; "(B) 3 shall be individuals distinguished in the practice of . . medicine "(C) 2 shall be individuals distinguished in the health professions; "(D) 2 shall be individuals distinguished in the fields of business, law, ethics, economics, and public policy; and "(E) 2 shall be individuals representing the interests of consumers of health care. (3) EX OFFICIO MEMBERS. The Secretary shall designate as ex officio members of the Council "(A) the Director of the National Institutes of Health, the Director of the Centers for Disease Control, the Adminis- trator of the Health Care Financing Administration, the Assistant Secretary of Defense (Health Affairs), the Chief Medical Officer of the Department of Veterans Affairs; and "(B) such other Federal officials as the Secretary may consider appropriate. (d) SUBCOUNCIL ON OUTCOMES AND C>UIDE~NES. (1) ESTABLISHMENT. For the purpose of carrying out the duties specified in subparagraphs (C) and (D) of subsection (bX2), the Secretary shall establish a subcouncil of the Council and shall designate the membership of the subcouncil in accordance with paragraph (2). "(2) MEMBERSHIP. The subcouncil established pursuant to paragraph (1) shall consist of "(A) 6 individuals from among the individuals appointed to the Council under subparagraphs (A) through (C) of subsection (c)(2) "(B) 2 individuals from among the individuals appointed to the Council under subparagraphs (D) and (E) of such subsection; gild "(C) each of the officials designated as e2: officio members of the Council under subsection (cX3XA). "(e) TERMS.- "(1) IN GENERAL. Except as provided in paragraph (2), mem- bers of the Council appointed under subsection (cX2) shall serve for a term of 3 years. (2) STAGGERED ROTATIOH.~f the members first appointed to the Council under subsection (c)(2), the Secretary shall appoint 6 members to serve for a term of 3 years, 6 members to serve for a term of 2 years, and 5 members to serve for a term of 1 year. (3) SERVICE BEYOND TERM.-A member of the Council ap- pointed under subsection (cX2) may continue to serve after the expiration of the term of the member until a successor is appointed. "(f) VACANCIES.-If a member of the Council appointed under subsection (c)(2) does not serve the full term applicable under subsec- tion (e), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.

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120 PUBLIC LAW 101-239 DEC. 19, 1989 "by) ~AIR. The Administrator shall, from among the members of the Council appointed under subsection (c)(2), designate an individual to serve as the chair of the Council. "(h) MEETINGS.-The Council shall meet not less than once during each discrete 4-month period and shall otherwise meet at the call of the Administrator or the chair. (i) COMPENSATION AND REIMBURSEMENT OF EXPENSES.- (1) APPOINTED MEMBERS.- Members of the Council appointed under subsection (cX2) shall receive compensation for each day (including traveltime) engaged in carrying out the duties of the Council 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 subsec- tion (cX3) as ex officio members of the Council may not receive compensation for service on the Council in addition to the compensation otherwise received for duties carried out as offi- cers of the United States. "(J.) STA=. The Administrator shall provide to the Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council. "no) DURATION.-Notwithstanding section 14(a? of the Federal . . Advisory Committee Act, the Council shall continue in existence until otherwise provided by law. CLINICAL PRACTICE GUIDELINES 103 STAT. 2201 "SEC. 922. PEER REVIEW WIT RESPECT TO Get ED CO=~. 42 UP 299c-1. (a) REQUIREMEN r OF REVIEW. "(1) IN GENES 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 ADMINISTRATOR. Each peer renew Coup to which an application is submitted pursuant to paragraph (1) shall report its finding and recommendations respecting the application to the Administrator in such form and in such manner as the Administrator shall require (b) APPROVE ~ PRECONDITION OF AWARDS.-The Administrator may not approve an application described in subsection (aX1) unless the application is recommended for approval by a peer renew group established under subsection (c). (C) E~rABMSHMENT OF PEER REVIEW GROUPS. "(1) IN GENE:R~. The Administrator 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 with- out 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 are not officers or employees of the United States and who by virtue of their training or experience are eminently qualified to carry out the duties of such peer review group. "(3) DUNN. Notwithstanding section 14(a) of the Federal Advisory Committee Act, peer review groups established under

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APPENDIX A 103 STAT. 2202 121 PUBLIC LAW 101-239 DEC. 19, 1989 this section shall continue in existence until otherwise provided by law. "(d) CATEGORIES or REV1~;W. "(1) IN GENERAL With respect to technical and scientific peer review under this section, such review of applications with respect to research, demonstration projects, or evaluations shall be conducted by different peer review groups than the peer rewew groups that conduct such review of applications with respect to insemination activities or the development of re- search agendas (including conferences, workshops, and meet- in~3). (2) AU rHORm FOR PROCEDURE DUSTMEN IN CON CASES. In the case of applications described in subsection (aX1) for financial assistance whose direct costs will not exceed $50,000, the Administrator may make appropriate adjustments in the procedures other established by the Administrator for the conduct of pee- rewew under this section. Such adjust meets may be made fo- 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 Arlmin~trator may determine to be appropriate. "(e) REGULATIONS. The Secretary shall hue regulations for the conduct of peer review under this section. 42 USC 299c-2. "SEC. 923. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, AND DISSEMINATION OF DATA (a) STANDARDS Wm] RESPECT TO UTI~5r OF DATA.- "(1) IN GENERA With respect to data developed or collected by any entity for the pure described in section 901(b), the Administrator shall, in order to assure the utility, accurate y, and sufficiency of such data for all interested entities, establish guidelines for uniform methods of developing- and collecting such data. Such guidelines shall include specifications for the development and collection of data on the outcomes of health care services and procedures "(2) RELATIONSHIP Wm! MEDICARE PROGRAM. In any Case where guidelines under paragraph (1) may affect the admix' - tration of the program under title XVIII of the Social Security Act, the guidelines shall be in the form of recommendations to the Secretary for such program. "(b) STA~CS. The Administrator shall "(1) take such action tic may be necessary to assure that statistics developed under this title are of high quality, timely and comprehensive, as well as specific, standardized, and add quately analyzed and indexed, and "(2) publish, make available, and disseminate such statistics on as wide a bum as ~ practicable. 42 USC 299c-3. "SEC. 924. ADDITIONAL PROVISIONS WITH RESPECI TO GRANTS AND CONTRACTS. "(a) REquIxE~rr OF APPLICATION. The Administrator may not, with respect to any program under this title authorinng the provi sion 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 confirm such agreements, Insurances,

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122 PUBLIC LAW 101-239- DEC. 19, 1989 and information as the Administrator determines to be necessary to carry out the program involved. (b) PROVISION OF SUPPLES AND SERVICES IN LIEU OF FUNDS. "(1) IN GENERA 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, equips meet, red services for the purpose of aiding the entity i ~ 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) CORKF~PONDING REDucr~oN 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 Administrator. The Secretary shall, for the Payment of ex- pe~Lses incurred in complying with such request, expend the amounts withheld. (C) APP~CABILrrY OF CEE.T~N PROVISIONS WrrH RE:SP~Cr TO CON- TRAC:S.~ontraCtS 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. 925. CERTAIN ADMINISTRATIVE AUTHORITIES. (a) DEPUTY ADM~N~TOR AND OrHE:R OmcERs AND EMPLOY- EES. "(1) DEPUTY ~DMINIsrn~ToR. The Administrator may am point a deputy administrator for the Agency. "(2) C,rHER amcERs AND EwP~o~. The Administrator 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 Fred in accordance with title 5, United States Code. "(b) FACILrrIES. The Secretary. in call out this title CLINICAL PRACTICE GUIDELINES 103 STAT. 2203 42 USC 299c - . District of "(1) may acquire, without regard to the Act of March 3 1877 Coi~bia (40 U.S.C. 34), by lease or otherwise through the Administrator Of General Services, buildings or portions of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed 10 years; and "(2) may acquire, construct, improve, repair, operate and mainly" 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 FrNANcL&I~ ASSISTANCE. The Administrator, in Grants. carrying out this title, may make grants to, and enter into coopera- Contracts tive agreements with, public and nonprofit private entities and individuals, and when appropriate, may enter into contracts with public and private entities and individuals. (d) UTILIZATION OF CERTAIN ~ONNEE AND RESOURCES. (1) DEPARTMENT OF HEALTH AND HUMAN SERVICES. The Administrator, 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 . ~, - ,

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APPENDIX A 103 STAT. 2204 123 PUBLIC LAW 101-239 DEC. 19, 1989 utilize the physical resources of such Department, and provide technical assistance and advice "(2) OTHER AGENCIES. Me Administrator, 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) CONSULTA~. The Secretary, in carrying out this title, may secure, from time to time and for such periods as the Administrator 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 consult- ants who have appropriate scientific or professional qualifica- tions. Such experts or consultants shall be obtained in accord- ance 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) Experts and consultants whose seances are obtained under paragraph (1) shall be paid or reimbursed for their expenses associated with traveling to and from their a~cign- ment location in accordance with sections 5724, 5724a(aX1) 5724a(a)(3), and 5726(c) of title 5, United States Code. "(B) 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 one year, whichever shorter, unless separated or reassigned for redone that are beyond the control of the expert or consultant and that "e acceptable to the Secretary. If the expert or consultant notates 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) VOLUN rARY AND UNCOMPEN SATED SERVICE. The Adm~ni~ trator, in carrying out this title, may accept voluntary and un- compensated services. 42 USC 299c-5. "SEC. 926. FUNDING. (a) A~ORIZATION OF APPROPRIATIONS. For the purpose of carrying out this title, there are authorized to be appropriated S35,000,000 for fiscal year 1990, $50,000,000 for fiscal year 1991, and S70,000,000 for fiscal year 1992. "(b) EVALUATIONS. In addition to amounts available pursuant to subsection (a) for carrying out this title, there shall be made avail- able for such purpose, from the amounts made available pursuant to section 2611 of this Act (relating to evaluations), an mnount equal to 40 percent of the maximum amount authorized in such section 2611 to be made available. 42 USC 299c-6. "SEC. 927. DEFINITIONS. "For purposes of this title:

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124 PUBLIC LAW 101-239- DEC. 19, 1989 "(1) The term 'Administrator' means the Administrator for Health Care Policy and Research. "(2) The term Agency' means the Agency for Health Care Policy and Research. "(3) The term 'Council' means the National Advisory Council on Health Care Policy, Search, and Evaluation. "(4) The term 'Director, means the Director of the Office of the Forum for Quality and Effectiveness in Health Care." (d) GENERAL PROVISIONS. (1) CONS. (A) The National Center for Health Services Research and Health Care Technology Assessment is terminated, and part A of title m of the Public Health Service Act (42 U.S.C 241 et seq.) is emended by striking section 305. 42 use 242c. (B) The council on health care technology established 42USC242n under section 309 of the Public Health Service Act is fermi- nle nated, and part A of title III of such Act is amended by striking section 309. 42 use 242n. (2) CONSTRICT FOR TEMPORARY ASSISTANCE TO SECRETARY WITH 42 USC 299a-2 RESPECT TO HEALTH CARE TECHNOLOGY ASSESSMEN r. note. (A) The Secretary of Health and Human Services shall request the Institute of Medicine of the National Academy of Sciences to enter into a contract (i) to develop and recommend to the Secretary pnor ities for the assessment of specific health care tech nologies under section 904 of the Public Health Service Act (as added by subsection (a) of this section), and (ii) to assist the Administrator for Health Care Policy and Research, and the Director of the National Library of Medicine, in establishing the information center required under subsection (cXl) of such section 904. (B) In carrying out section 904(cX1) of the Public Health Service Act (as added by suction (a) of this section), the Secretary of Health and Human Services shall, as appro priate, provide for the transfer to the Secretary of any information and materials developed by the council on health care technology under section 309(cXlXA) of the Public Health Service Act (as such section was in effect on the day before the effective date of this section). (C) The Secretary of Health and Human Services 8ha]1 ensure that the contract under subparagraph (A) specifi- that the activities described in clauses (i) and (ii) of such subparagraph shall be completed not later thstn 1 year after the date on which the Secretary enters into the contract. (D) For the purpose of carrying out the contract under Appropriation subparagraph (A), there is authorized to be appropriated authorization S300,000 for fecal year 1990. (e) TECHNICS AND CONFORMING AMENDMENTS. (1) SEASON 304. Section 304 of the Public Health Service Act (42 U.S.C. 242b) is atnended (A) in subsection (aW (i) by striking paragraphs (1) and (2); and (ii) by striking the paragraph designation in para- graph (3) (B) in subsection (a) (as mn ended by subparagraph (A) of thus paragraphs CLINICAL PRt4CTICR GUIDELINES 103 STAT. 2205 42 USC 242c note.

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APPENDIX A 103 STAT. 2206 125 PUBLIC LAW 101-239 DEC. 19, 1989 (i) by striking "the National Center for Health Ser~r ices Research and Health C=e Technology Assess meet" and inserting "the Agency for Health Care Policy Ad Research"; and (ii) by striking "in sections 305, 306, and 309" and Averting "in section 306 and in title IX" (C) in Function (b), in the matter preceding paragraph (1), by striking "subsection (a)," and inserting "subsection (a) and section 306,"; and (D) in subsection (c: (i) in paragraph (1), in the second sentence, by strik ing "the National Center for Health Sernces Research and Health Care Technology Assessment" and insert ing "the Agency for Health Care Policy and Research"; and (ii) in paragraph (2), by striking "the National Center for Health Services Research and Health Care Tech nology Assessment" and inserting "the Agency for Health Care Policy and Search". (2) SECTION 3~6. Section 306 of the Public Health Service Act (42 U.S.C. 242k) is amended- (A) in subsection (a), by adding at the end the following new sentence: "The Secretary, acting through the Center shall conduct and support statistical and epidemiolcgical activities for the purpose of improving the effectiveness efficiency, and quality of health services in the United star."; (B) in subsection (b), in the matter preceding paragraph (1) by striking "section 304(a)," and inserting "subsection (C) by adding at the end the following new subsection: Appropriation"(m) For health statistical and epidemiological activities under authorization.taken or supported under this section, there are authorized to be appropriated $55,000,000 for fiscal year 1988 and such Alms as may be necessary for each of the fiscal years ~ 989 and 1990.". (3) SECIION 307. Section 307(fi) of the Public Health Service Act (42 U.S.C. 2421(a)) is amended by striking "sections 304, 305 306, and 309" and inserting "section 306 and by title IX". (4) SEASON 30~. Section 308 of the Public Health Service Act (42 U.S.C. 242m) is ~mended (A) in the section heading, by striking "SEC rIONS" and all that follow and inserting the following: "EFF~=s, EFFICIENC1r, AND QUALrrY OF HEALTH SERVICES (B) in subsection (aW (i) in paragraph (lXAXi), by sting "sections 304 through 307 and section 309" and inserting "sections 304, 306, and 30 7 and title IX"; and (ii) in paragraph (2), by striking "the National Center for Health Services Research and Health Care Tech nology Assessment" and inserting "the Agency for Health Care Policy and Research" (C) in subsection (bW (i) in paragraph (1), by striking "sections 304, 305, 306, 307, and 309" and inserting "section 304 306, or 307"; (ii) in subparagraph (A) of paragraph (2 -

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126 CLINICAL PRACTICE GUIDELINES PUBLIC LAW 101-239 DEC. 19, 1989 (1) in the flat sentence, by striking "under sec- tion 304 or 305," and inserting "under section 306" (II) by striking the second sentence; and (m) by am ending the last sentence to read as follow: "The Director of the National Center for Health Statistics shall establish such peer review groups as may be necessary to provide for such an evaluation of each such application." (iii) in subparagraph (B) of paragraph (2), by striking "the Director involved," and inserting "the Director of the National Center for Health Statistics," (iv) in subparagraph (C) of paragraph (2), by striking "the Directors," and inserting "the Director of the National Center for Health Statistics,", and (v) in paragraph (3), in the first sentence (1) by striking "section .304, 305, or 306') the first place such term appears and inserting "section 306", and (II) by string "section 304, 305, or 306" the second place such term append and inserting "any of such sections"; 103 STAT. z207 (D) ~ suction (dW (i) in the matter preceding paragraph (1), by striking "section 304, 305, 306, 307, or 309 ' and inserting "sec- tion 304, 306, or 307" (ii) in paragraph (i), by striking "in other fonn, and" and inserting "in other form." and by striking the paragraph designation; and (iii) by striking paragraph (2X, (E) in subsection (eW (i) in paragraph (1), by striking "section 304, 305, 306, 307, or 309" and Averting "section 304, 306, or 307"; and (ii) in paragraph (2), in the matter preying subpa;ra- graph (A), by striking "section 304, 305, 306, 307, or 309 ' and inserting "section 304, 306, or 307" (To in subsection (f), by striking "section 304, 305, 306, or 309" and inserting "section 304 or 306" (G) in subsection (gym (i) in paragraph (1), by striking the matter after and below subparagraph (C), and (ii) in paragraph (2), by striking "sections 304, 305, 306, and 309" and inserting "sections 304 ant 306" (H) in suction (hX10 (i) by striking "section 304, 305, 306, or 309" the first place such term appears and inserting "section 306"; Ad (ii) by striking "section 304, 305' 306, or 309" the second place such term appears and inserting "any of such sections"; and (I) by striking subsection (i). (5) SEASON 330.~ion 330(eX3X&Xi) of the Public Health ~naiPn~. Service Act (42 U.S.C. 254c(eX3XGXi)) is amended by inserting after "(i)" the following: "except in the case of an entity oper ated by an Indian tribe or tribal or Indian organization under the Indian Self-Determination Act,".

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PPE1VDIX A 127 103 STAT. 2208 PUBLIC LAW 101-239 DEC. 19, 1989 (a) SERMON 402.-Section 402 of the Public Health Service 42 use ~ ~37 Amendments of 1987 is amended note. (A) by redesignating subsection (c) as subsection (d) and by inserting after subsection (b) the following new subsec tion: State and I ~"(c) Such Act is amended in section 411(cX2) by striking subpara s2vUrsncm~t~si graph (B), by striking 'subparagraphs (A) and (B)' in subparagraph 42 use fills (C), and by redesignating subparagraph (C) as subparagraph (B). Such Act is amended in section 415(a) by inserting before the period at the end the following: 'or ~ preempting or overriding any State law which provides incentives, immunities, or protection for those engaged in a professional review action that is in addition to or greater than that provided by this part"', and ~2 use iii37 (B) in subsection (dX1) (as so redesignated, by striking note. "subsection (a)" and inserting "subsections (a) and (c)'r (7) SECTION 487. Section 487(dX3XB) of the Public Health Service Act (42 U.S.C. 288(d)(3XB)) ~ Untended by striking "Na tional Center" and all that follows through "Assessment" and inserting "Agency for Health Care Policy and Research". 42 USC ~99 note. (f) TRANSITIONAL AND SAVINGS PROVISIONS. (1) TRANSFER OF PERSONNEL, ASSETS, AND MABILri]ES. Person nel of the Department of Health and Human Services employed on the date of the enactment of this Act in connection with the functions vested in the Administrator for Health Care Policy and Research pursuant to the amendments made by this sec tion, and assets, property, contracts, liabilities, records, unex pended balances of appropriations, authorizations, allocations, and other funds, of such Department arising from or employed held, used, or available on such date, or to be made available after such date, in connection with such functions shall be transferred to the Administrator for appropriate allocation. Unexpended funds transferred under this paragraph shall be used only for the purposes for which the funds were originally authorized and appropriated. (2) SAVINGS PROVISIONS.-With respect to functions vested in the Administrator for Health Care Policy sold Research pursu ant to the amendments made by this section, all orders, rules, regulations, grants, contracts, certificates licenses, privileges and other determinations, actions, or official documents, of the Department of Health and Human Services that have been issued, made, granted, or allowed to become effective in the performance of such functions, and that are elective on the date of the enactment of this Act, shall continue in effect according to their terms unless changed pursuant to law.