Directs the Director of the Agency for Healthcare Research and Quality to: (1) analyze such evidence; and (2) develop standards for the design and conduct of cost-effectiveness studies under this Act.
Establishes reporting requirements.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2356 Introduced in House (IH)]
108th CONGRESS
1st Session
H. R. 2356
To require the National Institutes of Health to conduct research, and
the Agency for Healthcare Research and Quality to conduct studies, on
the comparative effectiveness and cost-effectiveness of prescription
drugs that account for high levels of expenditures or use by
individuals in federally funded health programs, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 5, 2003
Mr. Allen (for himself, Mrs. Emerson, Mr. Berry, Mr. Bereuter, Mr.
Waxman, Mr. Burton of Indiana, Mr. Davis of Florida, Mr. Gutknecht, Mr.
Snyder, Mrs. Bono, Mr. Cooper, and Mr. Wamp) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To require the National Institutes of Health to conduct research, and
the Agency for Healthcare Research and Quality to conduct studies, on
the comparative effectiveness and cost-effectiveness of prescription
drugs that account for high levels of expenditures or use by
individuals in federally funded health programs, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prescription Drug Comparative
Effectiveness Act of 2003''.
SEC. 2. NIH RESEARCH AND AHRQ STUDY ON EFFECTIVENESS OF CERTAIN
PRESCRIPTION DRUGS.
(a) In General.--
(1) Research by nih.--The Director of the National
Institutes of Health, in coordination with the Director of the
Agency for Healthcare Research and Quality, shall conduct
research, which may include clinical research, to develop valid
scientific evidence regarding the comparative effectiveness,
cost-effectiveness, and, where appropriate, comparative safety
of covered prescription drugs relative to other drugs and
treatments for the same disease or condition.
(2) Analysis by ahrq.--
(A) In general.--The Director of the Agency for
Healthcare Research and Quality, taking into
consideration the research of the National Institutes
of Health under this section, shall use evidence-based
practice centers to conduct studies or other analyses
of the comparative effectiveness, cost-effectiveness,
and, where appropriate, comparative safety of covered
prescription drugs relative to other drugs and
treatments for the same disease or condition.
(B) Safety.--In any analysis of comparative
effectiveness or cost-effectiveness under this
subparagraph, the Director of the Agency for Healthcare
Research and Quality shall include a discussion of
available information on relative safety.
(3) Standards.--The Director of the Agency for Healthcare
Research and Quality, in consultation with the Commissioner of
Food and Drugs, the Director of the National Institutes of
Health, and stakeholders, shall develop standards for the
design and conduct of cost-effectiveness studies under this
subsection.
(b) Covered Prescription Drugs.--For purposes of this section, the
term ``covered prescription drugs'' means prescription drugs that, as
determined by the Director of the Agency for Healthcare Research and
Quality in consultation with the Administrator of the Centers for
Medicare & Medicaid Services, account for high levels of expenditures
or use by individuals in federally funded health programs, including
Medicare and Medicaid.
(c) Annual Report.--Each year the Director of the Agency for
Healthcare Research and Quality shall prepare a report on the results
of the research, studies, and analyses conducted by the National
Institutes of Health and the Agency for Healthcare Research and Quality
under this section and submit the report to the following:
(1) The Congress.
(2) The Secretary of Defense.
(3) The Secretary of Health and Human Services.
(4) The Secretary of Veterans Affairs.
(5) The Administrator of the Centers for Medicare &
Medicaid Services.
(6) The Director of the Indian Health Service.
(7) The Director of the National Institutes of Health.
(8) The Director of the Office of Personnel Management.
(d) Reports for Practitioners.--As soon as possible, but not later
than a year after the completion of any study pursuant to subsection
(a)(2), the Director of the Agency for Healthcare Research and Quality
shall--
(1) prepare a report on the results of such study for the
purpose of informing health care practitioners; and
(2) transmit the report to the Director of the National
Institutes of Health.
(e) NIH Internet Site.--The Director of the National Institutes of
Health shall publish on the Institutes' Internet site, and through
other means that will facilitate access by practitioners, each report
prepared under subsection (c) or (d) by the Director of the Agency for
Healthcare Research and Quality.
(f) Evidence.--In carrying out this section, the Directors of the
National Institutes of Health and the Agency for Healthcare Research
and Quality shall consider only methodologically sound studies, giving
preference to studies for which the Directors have access to sufficient
underlying data and analysis to address any significant concerns about
methodology or the reliability of data.
(g) Authorizations of Appropriations.--
(1) NIH.--There are authorized to be appropriated to the
National Institutes of Health to carry out this section
$50,000,000 for fiscal year 2004, and such sums as may be
necessary for fiscal years thereafter.
(2) AHRQ.--There are authorized to be appropriated to the
Agency for Healthcare Research and Quality to carry out this
section $25,000,000 for fiscal year 2004, and such sums as may
be necessary for fiscal years thereafter.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line