102d CONGRESS
2d Session
H. R. 5673
AN ACT
To amend the Public Health Service Act to revise and extend the programs of
the Agency for Health Care Policy and Research.
HR 5673 EH
102d CONGRESS
2d Session
H. R. 5673
AN ACT
To amend the Public Health Service Act to revise and extend the programs of
the Agency for Health Care Policy and Research.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,

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(a) SHORT TITLE- This Act may be cited as the `Agency for Health Care
Policy and Research Reauthorization Act of 1992'.
(b) AMENDATORY REFERENCES- Except as otherwise specifically provided,
whenever in this Act an amendment or repeal is expressed in terms of an
amendment to, or a repeal of, a section or other provision, the reference
shall be considered to be made to that section or other provision of the
Public Health Service Act (42 U.S.C. 201 et seq.).

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(a) ESTABLISHMENT- Section 901(b) (42 U.S.C. 299(b)) is amended by inserting
after `improvements in clinical practice' the following: `(including the
prevention of diseases and other health conditions)'.
(b) GENERAL AUTHORITIES- Section 902 (42 U.S.C. 299a) is amended--
(1) by redesignating subsections (c) and (d) as subsections (d) and (e),
respectively; and
(2) by inserting after subsection (b), the following subsection:
`(c) HEALTH SERVICES TRAINING GRANTS- The Administrator may provide training
grants in the field of health services research related to activities
authorized under subsection (a), to include pre- and post-doctoral
fellowships and training programs, young investigator awards, and other
programs and activities as appropriate.'.

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Section 903 (42 U.S.C. 299a-1) is amended by adding at the end the following
subsection:
`(e) INFORMATION CENTER-
`(1) IN GENERAL- There shall be established at the National Library of
Medicine an information center on health services research, and on selected
technology assessments and clinical practice guidelines produced by the
Agency and other public and private sources.
`(2) IDENTIFICATION SYSTEM- The Administrator shall ensure that information
under paragraph (1) concerning clinical practice guidelines is collected and
maintained electronically and in a convenient format. The Administrator,
in consultation with the Director of the National Library of Medicine,
shall develop and publish criteria for the inclusion of practice guidelines
and technology assessments in the information center database.
`(3) INTERAGENCY AGREEMENT- The Administrator shall enter into an agreement
providing for the implementation of paragraph (1) with the Director of
the National Library of Medicine.'.

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(a) IN GENERAL- Section 904 (42 U.S.C. 299a-2) is amended--
(1) in subsection (a)--
(A) by striking `and' at the end of paragraph (4);
(B) by striking the period at the end of paragraph (5) and inserting  `;
and'; and
(C) by adding at the end the following paragraph:
`(6) by conducting assessments and reassessments of existing and new health
care technologies.';
(2) in subsection (b)(2)--
(A) by striking `cost-effectiveness,'; and
(B) by adding at the end the following sentence: `In carrying out such
paragraph, the Administrator shall also consider the cost effectiveness
of such technologies where cost information is available and reliable.'; and
(3) in subsection (c) to read as follows:
`(c) AGENDA AND PRIORITIES-
`(1) ESTABLISHMENT OF PRIORITIES- In accordance with paragraph (2), the
Administrator, in consultation with the Advisory Council established under
section 921, shall establish an annual list of technology assessments under
consideration by the Agency, including those assessments performed at the
request of the Health Care Financing Administration and the Department of
Defense and those assessments performed under subsections (d) and (f).
`(2) PUBLIC NOTICE- The Administrator, in consultation with the Advisory
Council, shall publish the list established in paragraph (1) annually in
the Federal Register.';
(4) in subsection (d), to read as follows:
`(d) CONDUCT OF ASSESSMENTS-
`(1) IN GENERAL- The Administrator may conduct technology assessments in
addition to those assessments performed at the request of the Administrator
of the Health Care Financing Administration or of the Secretary of Defense.
`(2) CRITERIA- The Administrator shall develop criteria for determining
the priority of assessments performed under this subsection. Such criteria
shall include--
`(A) the prevalence of the health condition for which the technology aims
to prevent, diagnose, treat and clinically manage;
`(B) variations in current practice;
`(C) the economic burden posed by the prevention, diagnosis, treatment,
and clinical management of the health condition, including the impact on
publicly-funded  programs;
`(D) aggregate cost of the use of technology;
`(E) the morbidity and mortality associated with the health condition; and
`(F) the potential of an assessment to improve health outcomes or affect
costs associated with the prevention, diagnosis, or treatment of the
condition.'; and
(5) by adding at the end the following subsections:
`(e) DESCRIPTION OF PROCESS- Not later than January 1, 1994, the
Administrator shall develop and publish a description of the methodology
used to establish priorities for technology assessment and the process
used to conduct its technology assessments under this section.
`(f) PROGRAM OF INNOVATIVE ASSESSMENTS-
`(1) IN GENERAL- The Administrator may make grants to, or enter cooperative
agreements or contracts with, entities described in paragraph (2) for the
establishment of collaborative arrangements for the purpose of conducting
assessments of experimental, emerging, existing, or potentially outmoded
health care technologies, and for related activities. Such assessments
may include controlled clinical trials, large simple trials, and other
methodologies that can be conducted in partnership between the public and
private sectors or among multiple government agencies.
`(2) ELIGIBLE ENTITIES- The entities referred to in paragraph (1) are
entities determined to be appropriate by the Administrator, which entities
may include academic medical centers, research institutions, nonprofit
professional organizations, public or private third party payers, other
governmental agencies, and consortia of appropriate research entities
established for the purpose of conducting technology assessments.
`(3) USE OF AWARD- A grant, cooperative agreement, or contract under
paragraph (1) may be expended for data collection, data analysis, protocol
development, report development, dissemination and evaluation, and other
activities determined to be appropriate by the Administrator. Such funds
shall not be used for direct services.
`(4) APPLICATION FOR AWARD- To be eligible to receive a grant, cooperative
agreement, or contract under paragraph (1), an entity shall prepare and
submit to the Administrator an application, at such time, in such form,
and containing such information as the Administrator may require.
`(5) INTERAGENCY MEMORANDA OF UNDERSTANDING- In carrying out paragraph
(1), the Administrator may enter into memoranda of understanding with the
heads of other Federal agencies.'.
(b) REPORT REGARDING INNOVATIVE ASSESSMENTS- Not later than January 1,
1994, the Administrator for Health Care Policy and Research shall submit
to the Committee on Energy and Commerce of the House of Representatives,
and the Committee on Labor and Human Resources of the Senate, a report
concerning the program established in section 904(f) of the Public Health
Service Act (as added by subsection (a) of this section), including the
plan of such Administrator for implementing the program.

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(a) REQUIREMENTS FOR GUIDELINES, STANDARDS, PERFORMANCE MEASURES, AND
REVIEW CRITERIA-
(1) ADDITIONAL REQUIREMENTS- Section 912(b) (42 U.S.C. 299b-1) is amended--
(A) in paragraph (2), by striking `and' after the semicolon at the end;
(B) in paragraph (3), by striking the period at the end and inserting `;
and'; and
(C) by adding at the end the following paragraphs:
`(4) include information on risks and benefits of alternative strategies
for prevention, diagnosis, treatment, and management of a given disease,
disorder, or other health condition; and
`(5) include information on the costs of alternative strategies for the
prevention, diagnosis, treatment, and management of a given disease,
disorder, or other health condition, where cost information is available
and reliable.'.
(2) STUDY-
(A) To assist in carrying out the requirements of section 912(b)(4) of the
Public Health Service Act, as added by paragraph (1) of this subsection, the
Administrator for Health Care Policy and Research shall conduct or support a
study to develop methods for collecting and analyzing primary and secondary
data to be used in generating cost estimates of alternative strategies for
the prevention, diagnosis, treatment, and management of a given disease,
disorder, or the health condition to be included in guideline documents.
(B) Not later than June 1, 1994, the Administrator for Health Care Policy and
Research shall submit to the Committee on Energy and Commerce of the House
of Representatives, and to the Committee on Labor and Human Resources of
the Senate, a report concerning the study conducted under subparagraph (A).
(b) ADMINISTRATION OF OFFICE- Section 911 (42 U.S.C. 299b) is amended by
adding at the end the following sentence: `The Administrator shall carry
out this part acting through the Director.'.
(c) CONFORMING AMENDMENTS- Part B of title IX (42 U.S.C. 299b et seq.) is
amended--
(1) in section 912--
(A) in subsection (a)--
(i) in the first sentence, by striking `The' and all that follows through
`shall' and inserting `The Administrator shall'; and
(ii) in the second sentence, by striking `Director' and inserting
`Administrator'; and
(B) in subsection (c), by striking `Director' and inserting `Administrator';
(2) in section 913--
(A) in subsection (a), in the matter preceding paragraph (1), by striking
`Director' and inserting `Administrator';
(B) in subsection (b), in the matter preceding paragraph (1), by striking
`Director' and inserting `Administrator'; and
(C) in subsection (c), by striking `Director' each place such term appears
and inserting `Administrator'; and
(3) in section 914--
(A) in subsection (b)--
(i) in paragraph (1), by striking `Director' and inserting `Administrator';
(ii) in paragraph (2), by striking `Director' and inserting `Administrator';
(iii) in paragraph (3), in the matter preceding subparagraph (A), by striking
`Director' and inserting `Administrator'; and
(iv) in paragraph (4), by striking `Director' and inserting `Administrator';
(B) in subsection (c), in the first sentence, by striking `Director'
and inserting `Administrator';
(C) in subsection (d), in the first sentence, by striking `Director'
and inserting `Administrator'; and
(D) in subsection (e), by striking `Director' and inserting `Administrator'.
(d) PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS-
(1) ESTABLISHMENT OF PEER REVIEW GROUPS- Section 922(c)(2) (42
U.S.C. 299c-1(c)(2)) is amended--
(A) by striking `from among individuals' and all that follows through
`virtue' and inserting `from among individuals who by virtue'; and
(B) by adding at the end the following sentences: `Officers and employees
of the United States may not constitute more than 25 percent of the
membership of any such group. Such officers and employees may not receive
compensation for service on such groups in addition to the compensation
otherwise received for duties carried out as such officers and employees.'.
(2) CATEGORIES OF REVIEW- Section 922(d)(1) (42 U.S.C. 299c-1(d)(1))
is amended to read as follows:
`(1) IN GENERAL- With respect to technical and scientific peer review under
this section, there shall be two categories of peer review groups as follows:
`(A) One category of such groups shall, subject to subparagraph (B),
review applications with respect to research, demonstration projects,
or evaluations.
`(B) The other category of such groups shall review applications with
respect to dissemination activities or the development of research agendas
(including conferences, workshops, and meetings). If the purpose of a
proposal presented in an application is a matter described in the preceding
sentence, the application shall be reviewed by the groups referred to
in such sentence, notwithstanding that the proposal involves research,
demonstration projects, or evaluations.'.
(e) CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT, COLLECTION, AND
DISSEMINATION OF DATA- Section 923 (42 U.S.C. 299c-2) is amended by adding
at the end the following subsection:
`(c) AUTHORITY REGARDING CERTAIN REQUESTS- Upon the request of a public
or nonprofit private entity, the Administrator may tabulate and analyze
statistics under arrangements under which such entity will pay the cost
of the service provided. Amounts appropriated to the Administrator from
payments made under such arrangements shall be available to the Administrator
for obligation until expended.'.
(f) PROCESS FOR DEVELOPMENT OF GUIDELINES AND STANDARDS-
(1) MEMBERSHIP OF PANELS-
(A) Section 913(c) (42 U.S.C. 299b-2(c)) is amended--
(i) by inserting after the subsection designation the following sentence:
`The Administrator shall select the chairpersons and the members of the
panels convened as well as other participants in the guideline process
under this section.'; and
(ii) by adding at the end the following sentences: `In making such
selections, the Administrator shall ensure that a balance is maintained
between individuals selected from academic settings and individuals selected
without full-time academic appointments. At least two other members of such
panels shall be individuals who do not derive their primary source of revenue
directly from the performance of procedures discussed in the guideline. The
Administrator shall ensure that at least one participant in the guideline
process shall have expertise in epidemiology as well as familiarity with
the clinical condition or treatment in question. The Administrator shall
also ensure that at least one participant in the guideline process shall
have expertise in health services research or health economics as well as
familiarity with the clinical condition or treatment in question.'.
(B) The amendments made by subparagraph (A) shall apply only with respect
to panels convened under section 913 of the Public Health Service Act on
or after the date of enactment of this Act.
(2) STUDY OF PROCESS-
(A) The Administrator for Health Care Policy and Research shall conduct or
support a study to evaluate the process described in section 913 of the
Public Health Service Act for the development of guidelines, standards,
and review criteria. The  evaluation shall address--
(i) the optimal methods for setting priorities for guideline topics;
(ii) the different methods for generating guidelines, comparing the cost
of producing the guidelines and the validity and utility of the guidelines
produced; and
(iii) the methods for assessing the quality of practice guidelines, including
an evaluation of the validity, reliability, and impact of the guidelines.
(B) Not later than June 1, 1995, the Administrator for Health Care Policy and
Research shall submit to the Committee on Energy and Commerce of the House
of Representatives, and to the Committee on Labor and Human Resources of
the Senate, a report concerning the study conducted under subparagraph (A).

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(a) PROGRAM AGENDA- Section 914(a)(2)(A) (42 U.S.C. 299b-3(a)(2)(A))
is amended--
(1) by striking clause (i);
(2) by redesignating clauses (ii) and (iii) as clauses (iii) and (iv),
respectively; and
(3) by inserting before clause (iii) (as so redesignated) the following
clauses:
`(i) to improve methods for disease prevention;
`(ii) to improve methods of diagnosis, treatment, and clinical management
for the benefit of a significant number of individuals;'; and
(b) DUTIES- Section 912 (42 U.S.C. 299b-1) is amended by adding at the
end the following subsection:
`(f) DEVELOPMENT OF CERTAIN GUIDELINES AND STANDARDS- Not later than January
1, 1996, the Administrator shall ensure that a set of guidelines, standards,
performance measures, and review criteria, are developed under subsection
(a)(1) that address the prevention of not fewer than three conditions
that account for significant national health expenditures. In carrying
out this subsection the Administrator shall consult with the United States
Preventive Services Task Force and other recognized experts in the field
of disease prevention.'.

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Section 914 (42 U.S.C. 299b-3) is amended--
(1) in subsection (a)(2), by adding at the end the following subparagraph:
`(C) The Administrator shall develop and publish a methodology for
establishing priorities for guideline topics. Such methodology may include
the considerations described in section 904(c)(2) or 914(a)(2), and other
considerations determined by the Administrator to be appropriate.  Using such
methodology, the Administrator shall establish and publish annually in
the Federal Register a list of guideline topics under consideration.'; and
(2) in subsection (e), by adding at the end the following sentence:
`Evaluations shall be developed prior to the completion and release of the
guideline, so that baseline data concerning practice patterns and health
care costs may be obtained as part of the evaluation.'.

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Section 921 (42 U.S.C. 299c) is amended--
(1) by striking subsection (d);
(2) by redesignating subsections (e) through (k) as subsections (d) through
(j), respectively; and
(3) in subsection (e) (as so redesignated), by striking `subsection (e)'
and inserting  `subsection (d)'.

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Section 924 (42 U.S.C. 299c-3) is amended--
(1) by redesignating subsections (a) through (c) as subsections (b) through
(d), respectively; and
(2) by inserting before subsection (b) (as so redesignated) the following
subsection:
`(a) FINANCIAL CONFLICTS OF INTEREST- With respect to projects for which
awards of grants, cooperative agreements, or contracts are authorized to
be made under this title, the Administrator shall by regulation define--
`(1) the specific circumstances that constitute financial interests in
such projects that will, or may be reasonably expected to, create a bias
in favor of obtaining results in the projects that are consistent with
such interests; and
`(2) the actions that will be taken by the Administrator in response to
any such interests identified by the Administrator.'.

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Section 926 (42 U.S.C. 299c-5) is amended--
`(1) in subsection (a), to read as follows:
`(a) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this
title, there are authorized to be appropriated $115,000,000 for fiscal
year 1993, $145,000,000 in fiscal year 1994, and $175,000,000 in fiscal
year 1995.'; and
(2) by adding at the end the following subsections:
`(c) INFORMATION CENTER- For purposes of carrying out the activities
under section 903(e), there are authorized to be appropriated $3,000,000
for fiscal year 1993, and such sums as may be necessary for each of the
fiscal years 1994 and 1995.
`(d) HEALTH CARE TECHNOLOGY ASSESSMENT- For the purpose of carrying out
technology assessment activities under section 904(d), there are authorized
to be appropriated $2,000,000 for fiscal year 1993, and such sums as may
be necessary for each of the fiscal years 1994 and 1995.
`(e) PROGRAM OF INNOVATIVE ASSESSMENTS- For purposes of establishing
the program of innovative assessments under section 904(f), there are
authorized to be appropriated $2,000,000 for fiscal year 1993, and such
sums as may be necessary in each of the fiscal years 1994 and 1995.'.

4262447ea53f774d7de7c942bff1cf6161e32c04a2273c13c88b4b8a6a76aef4

Section 1910 (42 U.S.C. 300w-9) is amended--
(1) in subsection (a), by striking `not more than four grants in any fiscal
year' and inserting  `grants'; and
(2) in subsection (d)--
(A) by striking `and $5,000,000' and inserting  `$5,000,000'; and
(B) by inserting before the period the following: `, and such sums as may
be necessary for each of the fiscal years 1993 through 1997'.
Passed the House of Representatives September 24, 1992.
Attest:
Clerk.
HR 5673 EH----2

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Health Care Policy and Research Amendments of 1992 — HR. 5673

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