[DOCID: f:publ173.108]
MEDICARE PRESCRIPTION DRUG, IMPROVEMENT, AND MODERNIZATION ACT OF 2003
Public Law 108-173
108th Congress
SEC. 1013. <> RESEARCH ON OUTCOMES OF HEALTH CARE
ITEMS AND SERVICES.
(a) Research, Demonstrations, and Evaluations.--
(1) Improvement of effectiveness and efficiency.--
(A) In general.--To improve the quality,
effectiveness, and efficiency of health care delivered
pursuant to the programs established under titles XVIII,
XIX, and XXI of the Social Security Act, the Secretary
acting through the Director of the Agency for Healthcare
Research and Quality (in this section referred to as the
``Director''), shall conduct and support research to
meet the priorities and requests for scientific evidence
and information identified by such programs with respect
to--
(i) the outcomes, comparative clinical
effectiveness, and appropriateness of health care
items and services (including prescription drugs);
and
(ii) strategies for improving the efficiency
and effectiveness of such programs, including the
ways in which such items and services are
organized, managed, and delivered under such
programs.
(B) Specification.--To respond to priorities and
information requests in subparagraph (A), the Secretary
may conduct or support, by grant, contract, or
interagency agreement, research, demonstrations,
evaluations, technology assessments, or other
activities, including the provision of technical
assistance, scientific expertise, or methodological
assistance.
(2) Priorities.--
(A) In general.--The Secretary shall establish a
process to develop priorities that will guide the
research, demonstrations, and evaluation activities
undertaken pursuant to this section.
(B) Initial list.--Not later than 6 months after the
date of the enactment of this Act, the Secretary shall
establish an initial list of priorities for research
related to health care items and services (including
prescription drugs).
(C) Process.--In carrying out subparagraph (A), the
Secretary--
(i) shall ensure that there is broad and
ongoing consultation with relevant stakeholders in
identifying the highest priorities for research,
demonstrations, and evaluations to support and
improve the programs established under titles
XVIII, XIX, and XXI of the Social Security Act;
(ii) may include health care items and
services which impose a high cost on such
programs, as well as those which may be
underutilized or overutilized and which may
significantly improve the prevention, treatment,
or cure of diseases and conditions (including
chronic conditions) which impose high direct or
indirect costs on patients or society; and
(iii) shall ensure that the research and
activities undertaken pursuant to this section are
responsive to the specified priorities and are
conducted in a timely manner.
(3) Evaluation and synthesis of scientific evidence.--
(A) In general.--The Secretary shall--
(i) evaluate and synthesize available
scientific evidence related to health care items
and services (including prescription drugs)
identified as priorities in accordance with
paragraph (2) with respect to the comparative
clinical effectiveness, outcomes, appropriateness,
and provision of such items and services
(including prescription drugs);
(ii) identify issues for which existing
scientific evidence is insufficient with respect
to such health care items and services (including
prescription drugs);
(iii) disseminate to prescription drug plans
and MA-PD plans under part D of title XVIII of the
Social Security Act, other health plans, and the
public the findings made under clauses (i) and
(ii); and
(iv) work in voluntary collaboration with
public and private sector entities to facilitate
the development of new scientific knowledge
regarding health care items and services
(including prescription drugs).
(B) Initial research.--The Secretary shall complete
the evaluation and synthesis of the initial research
required by the priority list developed under paragraph
(2)(B) not later than 18 months after the development of
such list.
(C) Dissemination.--
(i) In general.--To enhance patient safety and
the quality of health care, the Secretary shall
make available and disseminate in appropriate
formats to prescription drugs plans under part D,
and MA-PD plans under part C, of title XVIII of
the Social Security Act, other health plans, and
the public the evaluations and syntheses prepared
pursuant to subparagraph (A) and the findings of
research conducted pursuant to paragraph (1). In
carrying out this clause the Secretary, in order
to facilitate the availability of such evaluations
and syntheses or findings at every decision point
in the health care system, shall--
(I) present such evaluations and
syntheses or findings in a form that is
easily understood by the individuals
receiving health care items and services
(including prescription drugs) under
such plans and periodically assess that
the requirements of this subclause have
been met; and
(II) provide such evaluations and
syntheses or findings and other relevant
information through easily accessible
and searchable electronic mechanisms,
and in hard copy formats as appropriate.
(ii) Rule of construction.--Nothing in this
section shall be construed as--
(I) affecting the authority of the
Secretary or the Commissioner of Food
and Drugs under the Federal Food, Drug,
and Cosmetic Act or the Public Health
Service Act; or
(II) conferring any authority
referred to in subclause (I) to the
Director.
(D) Accountability.--In carrying out this paragraph,
the Secretary shall implement activities in a manner
that--
(i) makes publicly available all scientific
evidence relied upon and the methodologies
employed, provided such evidence and method are
not protected from public disclosure by section
1905 of title 18, United States Code, or other
applicable law so that the results of the
research, analyses, or syntheses can be evaluated
or replicated; and
(ii) ensures that any information needs and
unresolved issues identified in subparagraph
(A)(ii) are taken into account in priority-setting
for future research conducted by the Secretary.
(4) Confidentiality.--
(A) In general.--In making use of administrative,
clinical, and program data and information developed or
collected with respect to the programs established under
titles XVIII, XIX, and XXI of the Social Security Act,
for purposes of carrying out the requirements of this
section or the activities authorized under title IX of
the Public Health Service Act (42 U.S.C. 299 et seq.),
such data and information shall be protected in
accordance with the confidentiality requirements of
title IX of the Public Health Service Act.
(B) Rule of construction.--Nothing in this section
shall be construed to require or permit the disclosure
of data provided to the Secretary that is otherwise
protected from disclosure under the Federal Food, Drug,
and Cosmetic Act, section 1905 of title 18, United
States Code, or other applicable law.
(5) Evaluations.--The Secretary shall conduct and support
evaluations of the activities carried out under this section to
determine the extent to which such activities have had an effect
on outcomes and utilization of health care items and services.
(6) Improving information available to health care
providers, patients, and policymakers.--Not later than 18 months
after the date of enactment of this Act, the Secretary shall
identify options that could be undertaken in voluntary
collaboration with private and public entities (as appropriate)
for the--
(A) provision of more timely information through the
programs established under titles XVIII, XIX, and XXI of
the Social Security Act, regarding the outcomes and
quality of patient care, including clinical and patient-
reported outcomes, especially with respect to
interventions and conditions for which clinical trials
would not be feasible or raise ethical concerns that are
difficult to address;
(B) acceleration of the adoption of innovation and
quality improvement under such programs; and
(C) development of management tools for the programs
established under titles XIX and XXI of the Social
Security Act, and with respect to the programs
established under such titles, assess the feasibility of
using administrative or claims data, to--
(i) improve oversight by State officials;
(ii) support Federal and State initiatives to
improve the quality, safety, and efficiency of
services provided under such programs; and
(iii) provide a basis for estimating the
fiscal and coverage impact of Federal or State
program and policy changes.
(b) Recommendations.--
(1) Disclaimer.--In carrying out this section, the Director
shall--
(A) not mandate national standards of clinical
practice or quality health care standards; and
(B) include in any recommendations resulting from
projects funded and published by the Director, a
corresponding reference to the prohibition described in
subparagraph (A).
(2) Requirement for implementation.--Research, evaluation,
and communication activities performed pursuant to this section
shall reflect the principle that clinicians and patients should
have the best available evidence upon which to make choices in
health care items and services, in providers, and in health care
delivery systems, recognizing that patient subpopulations and
patient and physician preferences may vary.
(3) Rule of construction.--Nothing in this section shall be
construed to provide the Director with authority to mandate a
national standard or require a specific approach to quality
measurement and reporting.
(c) Research With Respect to Dissemination.--The Secretary, acting
through the Director, may conduct or support research with respect to
improving methods of disseminating information in accordance with
subsection (a)(3)(C).
(d) Limitation on CMS.--The Administrator of the Centers for
Medicare & Medicaid Services may not use data obtained in accordance
with this section to withhold coverage of a prescription drug.
(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $50,000,000 for fiscal year
2004, and such sums as may be necessary for each fiscal year thereafter.