Health Promotion and Disease Prevention Amend­ments of 1984

PUBLIC LAW 98-551—OCT. 30, 1984 98 STAT. 2815
Public Law 98-551
98th Congress
An Act
To revise and extend provisions of the Public Health Service Act relating to health
promotion and disease prevention, to provide for the establishment of centers for
research and demonstrations concerning health promotion and disease prevention,
and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That this Act may
be cited as the "Health Promotion and Disease Prevention Amend­
ments of 1984".
SEC. 2. (a)(1) Section 1701(a) of the Public Health Service Act (42
U.S.C. 300u(a)) is amended—
(A) by striking out "and" after the semicolon in paragraph (8);
(B) by striking out the period at the end of paragraph (9) and
inserting in lieu thereof a semicolon and "and";
(C) by inserting after paragraph (9) the following new
paragraph:
"(10) establish in the Office of the Assistant Secretary for
Health an Office of Disease Prevention and Health Promotion,
which shall—
"(A) coordinate all activities within the Department
which relate to disease prevention, health promotion, pre­
ventive health services, and health information and educa­
tion with respect to the appropriate use of health care;
"(B) coordinate such activities with similar activities in
the private sector;
"(C) establish a national information clearinghouse to
facilitate the exchange of information concerning matters
relating to health information and health promotion, pre­
ventive health services, and education in the appropriate
use of health care, to facilitate access to such information,
and to assist in the analysis of issues and problems relating
to such matters; and
"(D) support projects, conduct research, and disseminate
information relating to preventive medicine, health promo­
tion, and physical fitness and sports medicine.";
(D) by striking out "and with health planning and resource
development activities undertaken under titles XV and XVI" in
the last sentence; and
(E) by adding at the end thereof the following: "The Secretary
shall appoint a Director for the Office of Disease Prevention and
Health Promotion established pursuant to paragraph (10) of this
subsection. The Secretary shall administer this title in coopera­
tion with health care providers, educators, voluntary organiza­
tions, businesses, and State and local health agencies in order to
encourage the dissemination of health information and health
promotion activities.".
(2) Section 1701(b) of such Act is amended to read as follows: Oct. 30, 1984
[S. 771]
Health
Promotion and
Disease
Prevention
Amendments of
1984.
42 use 201 note.
Education.
Office of Dis­
ease Prevention
and Health
Promotion,
establishment.
42 use 300k-l,
300q. 98 STAT. 2816 PUBLIC LAW 98-551—OCT. 30, 1984
"(b) To carry out this title, there are authorized to be appropriated
$9,000,000 for the fiscal year ending September 30, 1985, $9,500,000
for the fiscal year ending September 30, 1986, and $10,000,000 for
the fiscal year ending September 30,1987.".
(b) Paragraph (6) of section 1704 of such Act (42 U.S.C. 300u-3(6))
IS rGOGfl-lGd
(c) Sections 1706, 1707, 1708, 1709, and 1710 of such Act (42 U.S.C.
300U-5, 300U-6, 300u-7, 300u-8, and 300u-9) are repealed.
(d) Title XVII of such Act is amended by adding at the end thereof
the following new sections:
"CENTERS FOR RESEARCH AND DEMONSTRATION OF HEALTH PROMOTION
AND DISEASE PREVENTION
42USC300U-5. "SEC. 1706. (a) The Secretary shall make grants or enter into
Grants. contracts with academic health centers for the establishment, main­
tenance, and operation of centers for research and demonstration
with respect to health promotion and disease prevention. Centers
established, maintained, or operated under this section shall under­
take research and demonstration projects in health promotion, dis­
ease prevention, and improved methods of appraising health
hazards and risk factors, and shall serve as demonstration sites for
the use of new and innovative research in public health techniques
to prevent chronic diseases.
"(b) Each center established, maintained, or operated under this
section shall—
"(1) be located in an academic health center with—
"(A) a multidisciplinary faculty with expertise in public
health and which has working relationships with relevant
groups in such fields as medicine, psychology, nursing,
social work, education and business;
"(B) graduate training programs relevant to disease
prevention;
"(C) a core faculty in epidemiology, biostatistics, social
sciences, behavioral and environmental health sciences,
and health administration;
"(D) a demonstrated curriculum in disease prevention;
"(E) a capability for residency training in public health or
preventive medicine; and
"(F) such other qualifications as the Secretary may
prescribe;
"(2) conduct—
"(A) health promotion and disease prevention research,
including retrospective studies and longitudinal prospective
studies in population groups and communities;
"(B) demonstration projects for the delivery of services
relating to health promotion and disease prevention to
defined population groups using, as appropriate, commu­
nity outreach and organization techniques and other meth­
ods of educating and motivating communities; and
Study. "(C) evaluation studies on the efficacy of demonstration
projects conducted under subparagraph (B) of this
paragraph.
Study. The design of any evaluation study conducted under subparagraph
(C) shall be established prior to the commencement of the demon­
stration project under subparagraph (B) for which the evaluation
will be conducted. PUBLIC LAW 98-551—OCT. 30, 1984 98 STAT. 2817
"(c)(1) During fiscal year 1985, the Secretary shall make grants or
enter into contracts for the establishment of three centers under
this section. During fiscal year 1986, the Secretary shall make
grants and enter into contracts for the establishment of five centers
under this section and the maintenance and operation of the three
centers established under this section in fiscal year 1985. During
fiscal year 1987, the Secretary shall make grants and enter into
contracts for the establishment of five centers under this section and
the operation and maintenance of the eight centers established
under this section in fiscal years 1985 and 1986.
"(2)(A) In making grants and entering into contracts under this
section, the Secretary shall provide for an equitable geographical
distribution of centers established, maintained, and operated under
this section and for the distribution of such centers among areas
containing a wide range of population groups which exhibit
incidences of diseases which are most amenable to preventive
intervention.
"(B) The Secretary, through the Director of the Centers for Dis­
ease Control and in consultation with the Director of the National
Institutes of Health, shall establish procedures for the appropriate
peer review of applications for grants and contracts under this
section by peer review groups composed principally of non-Federal
experts.
"(d) For purposes of this section, the term 'academic health center'
means a school of medicine, a school of osteopathy, or a school of
public health, as such terms are defined in section 701(4).
"(e) To carry out this section, there are authorized to be appropri­
ated $3,000,000 for the fiscal year ending September 30, 1985,
$8,000,000 for the fiscal year ending September 30, 1986, and
$13,000,000 for the fiscal year ending September 30,1987.".
SEC. 3. Subsection (a) of section 338G of the Public Health Service
Act (42 U.S.C. 254r(a)) is amended by inserting "clinical psycholo­
gists," after "pharmacists,".
SEC. 4. (a) Section 526(a)(2) of the Federal Food, Drug, and Cos­
metic Act (21 U.S.C. 360bb(a)(2)) is amended by striking out "which
occurs so infrequently in the United States that" and inserting in
lieu thereof "which (A) affects less than 200,000 persons in the
United States, or (B) affects more than 200,000 in the United States
and for which".
(b) Section 5(b)(2) of the Orphan Drug Act (21 U.S.C. 360ee(b)(2)) is
amended by striking out "which occurs so infrequently in the
United States that" and inserting in lieu thereof "which (A) affects
less than 200,000 persons in the United States, or (B) affects more
than 200,000 in the United States and for which".
SEC. 5. (a) Section 305 of the Public Health Service Act (42 U.S.C.
242c) is amended—
(1) by striking out "National Center for Health Services
Research" and inserting in lieu thereof "National Center for
Health Services Research and Health Care Technology
Assessment";
(2) in subsection (b), by striking out "and" at the end of
paragraph (3), by striking out the period at the end of paragraph
(4) and inserting in lieu thereof "; and", and by adding after
paragraph (4) the following:
"(5) the safety, efficacy, effectiveness, cost effectiveness, eco­
nomic, and social impacts of health care technologies."; and Contracts with
U.S.
Contracts with
U.S.
Contracts with
U.S.
Appropriation
authorization. 98 STAT. 2818 PUBLIC LAW 98-551—OCT. 30, 1984
Science and
technology.
Grants.
Contracts with
U.S.
Science and
technology.
National
Advisory Council
on Health Care
Technology
Assessment,
establishment. (3) by redesignating subsection (e) as subsection (i) and by
adding after subsection (d) the following:
"(eXD The Center shall advise the Secretary respecting health
care technology issues and make recommendations with respect to
whether specific health care technologies should be reimbursable
under federally financed health programs.
"(2) In making recommendations respecting health care technol-
(^es, the Center shall consider the safety, efficacy, and effective­
ness, and, as appropriate, the cost-effectiveness and appropriate uses
of the technology.
"(3) In carrying out its responsibilities under this section respect­
ing health care technolc^es, the Center shall cooperate and consult
with the National Institutes of Health, the Food and Drug Adminis­
tration, and any other interested Federal departments or agencies.
"(fXD The Secretary, acting through the Center, shall undertake
and support (by grant or contract) research regarding technology
difTusion, methods to assess health care technology, and specific
health care technologies.
"(2) Any grant or contract under paragraph (1), the direct cost of
which will exceed $50,000, may be made or entered into only after
consultation with the National Advisory Coimcil on Health Care
Technolc^y Assessment.
"(gXD There is established the National Advisory Council on
Health Care Technology Assessment (hereinafter in this section
referred to as the 'CJouncil'). The Coimcil shall advise the Secretary
and the Director of the Center with respect to the performance of
the health care technology assessment functions prescribed by this
section. The Council shall assist the Director in developing criteria
and methods to be used by the dlenter in making he^th care
technology coverage recommendations.
"(2) The Council shall consist of—
"(A) the Director of the National Institutes of Health, the
Chief Medical Director of the Veterans' Administration, the
Assistant Secretary for Health and Environment of the Depart­
ment of Defense, the head of the Centers for Disease Control,
the head of the Health Care Financing Administration, and
such other Federal officials as the Secretary may specify, who
shall be ex officio members, and
"(B) twelve voting members appointed by ths Secretary.
"(3) The Secretary shall make appointments to the (I!ouncil as
follows:
"(A) The Secretary shall appoint six members of the C!ouncil
from individuals who are distinguished in the fields of medicine,
engineering, and science (including social science) and shall
appoint four members from individuals who are distinguished
in the fields of law, ethics, economics, and management. Of the
members appointed under this subparagraph—
"(i) at least two shall be physicians,
"(ii) two shall be selected from individuals who represent
business entities engaged in development or production of
medical technol(^;y,
"(iii) one shall be selected from individuals who represent
hospital administrators, and
"(iv) one shall be selected from individuals who represent
health insurance companies or self-insured employers. PUBLIC LAW 98-551—OCT. 30, 1984 98 STAT. 2819
"(B) The Secretary shall appoint two members from members
of the general public who represent the interest of consumers of
health care.
"(4)(A) Each appointed member of the Council shall be appointed
for a term of three years, except that—
"(i) any member appointed to fill a vacancy occurring prior to
the expiration of the term for which his predecessor was
appointed shall be appointed for the remainder of such term;
and
"(ii) of the members first appointed after the date of the
enactment of this subsection, four shall be appointed for a term
of three years, four shall be appointed for a term of two years,
and four shall be appointed for a term of one year, as designated
by the Secretary at the time of appointment.
Appointed members may be appointed for additional terms and may
serve after the expiration of their terms until their successors have
taken office.
"(B) Members of the Council who are not officers or employees of
the United States shall receive for each day they are engaged in the
performance of the functions of the Council compensation at rates
not to exceed the daily equivalent of the annual rate in effect for
grade GS-18 of the General Schedule, including traveltime; and all 5 use 5332 note,
members, while so serving away from their homes or regular places
of business, may be allowed travel expenses, including per diem in
lieu of subsistence, in the same manner as such expenses are
authorized by section 5703 of title 5, United States Code, for persons
in the Government service employed intermittently.
"(5) The Council shall annually elect one of its appointed members
to serve as Chairman until the next election.
"(6) The Council shall meet at the call of the Chairman, but not
less often than three times a year.
"(7) The Director of the Center shall (A) designate a member of
the staff of the Center to act as Executive Secretary of the Council,
and (B) make available to the Council such staff, information, and
other assistance as it may require to carry out its functions.
"(h) In each fiscal year, seven and one-half percent of the amount Contracts with
made available under section 2113 for such fiscal year for evalua- U.S.
tions shall be made available to the Assistant Secretary for Health ^i"^"*^
to conduct or support Ot)y both grants and contracts) through the ^*^* ^^^
Center, evaluations of health services and health care technology
which evaluations are not being conducted or supported under this
section or section 304.".
(b) Subsection (i) of such section (as so redesignated) is amended by
striking out "subsections (b), (c), and (d) of.
(cXD Section 304 of such Act (42 U.S.C. 242b) is amended by
striking out "National Center for Health Services Research" each
place it occurs and inserting in lieu thereof "National Center for
Health Services Research and Health Care Technology
Assessment".
(2) Such section is amended by striking out ", the National Center
for Health Statistics, and the National Center for Health Care
Technology" each place it occurs and inserting in lieu thereof "and
the National Center for Health Statistics".
(3) Such section is amended by striking out ", the National Center
for Health Statistics, or the National Center for Health Care Tech­
nology" and inserting in lieu thereof "or the National Center for
Health Statistics". 98 STAT. 2820 PUBLIC LAW 98-551—OCT. 30, 1984
(4) The heading for such section is amended by striking out "and
Health Care Technology" and inserting in lieu thereof ", and Health
Care Technology Assessment".
42 use 242c. SEC. 6. Section 305(c) is amended—
(1) by redesignating paragraphs (1), (2), and (3) as subpara­
graphs (A), (B), and (C), respectively;
(2) by inserting "(1)" before "The"; and
(3) by adding at the end thereof the following new paragraph:
"(2) In carrying out this section, the Secretary shall assist State
and local health agencies through a user liaison program and a
technical assistance program.".
SEC. 7. (a)(1) The first sentence of paragraph (1) of section 308(i) of
such Act (42 U.S.C. 242m(i)) is amended by striking out "and" after
"1983," and by inserting before the period a comma and the follow­
ing: "$20,500,000 for the fiscal year ending September 30, 1985,
$22,750,000 for the fiscal year ending September 30, 1986, and
$24,750,000 for the fiscal year ending September 30,1987".
(2) The second sentence of such paragraph is amended (A) by
inserting after "Research" the following: "and Health Care Technol­
ogy Assessment", and (B) by striking out "and at least 5 per centum
of such amount or $1,000,000, whichever is less, shall be available
only for dissemination activities directly undertaken through such
Center" and inserting in lieu thereof "and at least 10 per centum of
such amount or $1,500,000, whichever is less, shall be available only
for the user liaison program and the technical assistance program
referred to in section 305(c)(2) and for dissemination activities
directly underteiken through such Center".
(3) Such paragraph is amended by adding after the second sen­
tence the following: "For health care technology assessment activi­
ties undertaken under subsections (b)(5), (e), (f), and (g) of section 305
the Secretary shall obligate from funds appropriated under this
paragraph not less than $3,000,000 for the fiscal year ending Sep­
tember 30, 1985, $3,500,000 for the fiscal year ending September 30,
1986, and $4,000,000 for the fiscal year ending September 30, 1987.
For grants under section 309 the Secretary shall obligate from funds
appropriated under this paragraph not less than $500,000 for the
fiscal year ending September 30, 1985, $750,000 for the fiscal year
ending September 30, 1986, and $750,000 for the fiscal year ending
September 30,1987.".
(4) The last sentence of such paragraph is amended by striking out
"for each" through "1984," and inserting in lieu thereof "for any
fiscal year".
Ot)) Paragraph (2) of such section is amended by striking out "and"
after "1983," and by inserting before the period a comma and the
following: "$47,000,000 for the fiscal year ending September 30,
1985, $49,000,000 for the fiscal year ending September 30, 1986, and
$52,000,000 for the fiscal year ending September 30,1987".
SEC. 8. Section 309 of the Public Health Service Act (42 U.S.C.
242n) is amended to read as follows:
"COUNCIL ON HEALTH CARE TECHNOLOGY
Grants. "SEC. 309. (aXD In accordance with this section, the Secretary
shall make grants for the planning, development, establishment,
and operation of a Council on Health Care Technology. The Council
shall comply with the provisions of this section. PUBLIC LAW 98-551—OCT. 30, 1984 98 STAT. 2821
"(2XA) The Secretary shall make an initial grant under paragraph
(1) to the National Academy of Sciences for the planning, develop­
ment, and establishment of the Council with the membership pre­
scribed by subsection (d)(1). The amount of such grant may not
exceed $500,000 and may be made for not more than two-thirds of
the cost of the planning, development, and establishment of the
Council.
"(B) The Secretary may not make a grant for the operation of the
Council unless the application submitted to the Secretary for the
grant contains written assurances from the applicant that the appli­
cant will expend from non-Federal sources for the operation of the
Council an amount equal to at least twice the amount of the grant
applied for.
"Ot)) The purposes of the Council shall include—
"(1) promoting the development and application of appropri­
ate health care technology assessments; and
"(2) the review of existing health care technologies in order to
identify obsolete or inappropriately used health care technol­
ogies.
"(CXD The Council shall— Science and
"(A) serve as a clearinghouse for information on health care technology.
technologies and health care technology assessment;
"(B) collect and analyze data concerning specific health care
technologies;
"(C) identify needs in the assessment of specific health care
technologies and research on assessment methodologies;
"(D) develop and evaluate criteria and methodologies for
health care technology Eissessment;
"(E) promote education, training, and technical assistance in
the use of health care technology assessment methodologies and
results; and
"(F) stimulate, coordinate, and commission assessments of
health care technologies.
"(2) No funds from any grant made by the Secretary under this
section for the planning, development, and establishment of the
Council may be used to conduct any Eissessment of a health care
technology.
"(d)(1) For purposes of a grant for the planning, development, and
establishment of the Council, the Council shall be composed of:
"(A) At least ten members appointed by the National Acad­
emy of Sciences from individuals who have education, training,
experience, or expertise relating to the quality and cost-effec­
tiveness of health care technologies and who are representatives
of organizations of health professionals, hospitals, and other
health care providers, health care insurers, employers, consum­
ers, and manufacturers of products for health care.
"(B) Three members appointed by the Secretary of Health and
Human Services.
"(C) The Director of the Office of Technology Assessment, who
shall be an ex officio member.
"(2) Any vacancy in the Council shall not affect its power and, for
purposes of a grant for the planning, development, and establish­
ment of the Council, shall be filled in the manner prescribed by
paragraph (1).
"(f) The President of the National Academy of Science shall
designate one of the members appointed to the initial Council under
subsection (dXlXA) as Chairman of the Council for a one-year term.
31-194 0-86-15 : QL.3 Part3 98 STAT. 2822 PUBLIC LAW 98-551—OCT. 30, 1984
Thereafter, the members of the Council shall elect one of its mem­
bers as Chairman for such terms as may be determined by the
Council.
Report. "(g) The recipient of a grant under subsection (a) shall submit an
annual report to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Labor and Human
Resources of the Senate on the Council's activities.
"(h) No grant may be made under this section unless an applica­
tion is submitted to the Secretary in such form and containing such
information as the Secretary shall prescribe.".
Approved October 30, 1984.
LEGISLATIVE HISTORY—S. 771:
SENATE REPORT No. 98-158 (Comm. on Labor and Human Resources).
CONGRESSIONAL RECORD:
Vol. 129 (1983): Sept. 21, considered and passed Senate.
Vol. 130 (1984): Oct. 9, considered and passed House, amended.
Oct. 11, Senate concurred in House amendment.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 20, No. 44 (1984):
Oct. 30, Presidential statement.