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OCR for page 107
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
OCR for page 108
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.
OCR for page 109
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
OCR for page 110
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
OCR for page 111
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.
OCR for page 112
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.
OCR for page 113
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
OCR for page 114
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-
OCR for page 115
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;
OCR for page 116
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
OCR for page 117
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- n°le
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.
Representative terms from entire chapter:
clinical practice
