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Appendix E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 727
submit a report to Congress containing the results of the
Affordable Care Act (ACA) (2010)
evaluation conducted under subparagraph (A).
(b) F .—
UNDING
Provisions.—The Secretary Patient-Centered
for the of Health and Human
(1) N OTIFICATION
Services shall notify the Secretary of the Treasury of the
amount necessary to carry out the nationwide program under
Ohis section in nothe Research Institute 2012,
t utcomes period of fiscal years 2010 through (PCORI)
for
except that case shall such amount exceed $160,000,000.
(2) TRANSFER OF FUNDS.—
(A) IN GENERAL.—Out of any funds in the Treasury
not otherwise appropriated, the Secretary of the Treasury
shall provide for the transfer to the Secretary of Health
and Human Services of the amount specified as necessary
to carry out the nationwide program under paragraph (1).
Such amount shall remain available until expended.
(B) RESERVATION OF FUNDS FOR CONDUCT OF EVALUA-
TION.—The Secretary may reserve not more than
$3,000,000 of the amount transferred under subparagraph
(A) to provide for the conduct of the evaluation under
subsection (a)(7)(A).
Subtitle D—Patient-Centered Outcomes
Research
SEC. 6301. PATIENT-CENTERED OUTCOMES RESEARCH.
(a) IN GENERAL.—Title XI of the Social Security Act (42 U.S.C.
1301 et seq.) is amended by adding at the end the following new
part:
‘‘PART D—COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH
‘‘COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH
‘‘SEC. 1181. (a) DEFINITIONS.—In this section: 42 USC 1320e.
‘‘(1) BOARD.—The term ‘Board’ means the Board of Gov-
ernors established under subsection (f).
‘‘(2) COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH;
RESEARCH.—
‘‘(A) IN GENERAL.—The terms ‘comparative clinical
effectiveness research’ and ‘research’ mean research evalu-
ating and comparing health outcomes and the clinical
effectiveness, risks, and benefits of 2 or more medical treat-
ments, services, and items described in subparagraph (B).
‘‘(B) MEDICAL TREATMENTS, SERVICES, AND ITEMS
DESCRIBED.—The medical treatments, services, and items
described in this subparagraph are health care interven-
tions, protocols for treatment, care management, and
delivery, procedures, medical devices, diagnostic tools,
pharmaceuticals (including drugs and biologicals), integra-
tive health practices, and any other strategies or items
being used in the treatment, management, and diagnosis
of, or prevention of illness or injury in, individuals.
‘‘(3) CONFLICT OF INTEREST.—The term ‘conflict of interest’
means an association, including a financial or personal associa-
tion, that have the potential to bias or have the appearance
9
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20 LEARNING WHAT WORKS
124 STAT. 728 PUBLIC LAW 111–148—MAR. 23, 2010
of biasing an individual’s decisions in matters related to the
Institute or the conduct of activities under this section.
‘‘(4) REAL CONFLICT OF INTEREST.—The term ‘real conflict
of interest’ means any instance where a member of the Board,
the methodology committee established under subsection (d)(6),
or an advisory panel appointed under subsection (d)(4), or a
close relative of such member, has received or could receive
either of the following:
‘‘(A) A direct financial benefit of any amount deriving
from the result or findings of a study conducted under
this section.
‘‘(B) A financial benefit from individuals or companies
that own or manufacture medical treatments, services, or
items to be studied under this section that in the aggregate
exceeds $10,000 per year. For purposes of the preceding
sentence, a financial benefit includes honoraria, fees, stock,
or other financial benefit and the current value of the
member or close relative’s already existing stock holdings,
in addition to any direct financial benefit deriving from
the results or findings of a study conducted under this
section.
‘‘(b) PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE.—
‘‘(1) ESTABLISHMENT.—There is authorized to be established
a nonprofit corporation, to be known as the ‘Patient-Centered
Outcomes Research Institute’ (referred to in this section as
the ‘Institute’) which is neither an agency nor establishment
of the United States Government.
‘‘(2) APPLICATION OF PROVISIONS.—The Institute shall be
District of
Columbia. subject to the provisions of this section, and, to the extent
consistent with this section, to the District of Columbia Non-
profit Corporation Act.
‘‘(3) FUNDING OF COMPARATIVE CLINICAL EFFECTIVENESS
RESEARCH.—For fiscal year 2010 and each subsequent fiscal
year, amounts in the Patient-Centered Outcomes Research
Trust Fund (referred to in this section as the ‘PCORTF’) under
section 9511 of the Internal Revenue Code of 1986 shall be
available, without further appropriation, to the Institute to
carry out this section.
‘‘(c) PURPOSE.—The purpose of the Institute is to assist patients,
clinicians, purchasers, and policy-makers in making informed health
decisions by advancing the quality and relevance of evidence con-
cerning the manner in which diseases, disorders, and other health
conditions can effectively and appropriately be prevented,
diagnosed, treated, monitored, and managed through research and
evidence synthesis that considers variations in patient subpopula-
tions, and the dissemination of research findings with respect to
the relative health outcomes, clinical effectiveness, and appropriate-
ness of the medical treatments, services, and items described in
subsection (a)(2)(B).
‘‘(d) DUTIES.—
‘‘(1) IDENTIFYING RESEARCH PRIORITIES AND ESTABLISHING
RESEARCH PROJECT AGENDA.—
‘‘(A) IDENTIFYING RESEARCH PRIORITIES.—The Institute
shall identify national priorities for research, taking into
account factors of disease incidence, prevalence, and burden
in the United States (with emphasis on chronic conditions),
gaps in evidence in terms of clinical outcomes, practice
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2
APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 729
variations and health disparities in terms of delivery and
outcomes of care, the potential for new evidence to improve
patient health, well-being, and the quality of care, the
effect on national expenditures associated with a health
care treatment, strategy, or health conditions, as well as
patient needs, outcomes, and preferences, the relevance
to patients and clinicians in making informed health
decisions, and priorities in the National Strategy for quality
care established under section 399H of the Public Health
Service Act that are consistent with this section.
‘‘(B) ESTABLISHING RESEARCH PROJECT AGENDA.—The
Institute shall establish and update a research project
agenda for research to address the priorities identified
under subparagraph (A), taking into consideration the
types of research that might address each priority and
the relative value (determined based on the cost of con-
ducting research compared to the potential usefulness of
the information produced by research) associated with the
different types of research, and such other factors as the
Institute determines appropriate.
‘‘(2) CARRYING OUT RESEARCH PROJECT AGENDA.—
‘‘(A) RESEARCH.—The Institute shall carry out the
research project agenda established under paragraph (1)(B)
in accordance with the methodological standards adopted
under paragraph (9) using methods, including the following:
‘‘(i) Systematic reviews and assessments of existing
and future research and evidence including original
research conducted subsequent to the date of the enact-
ment of this section.
‘‘(ii) Primary research, such as randomized clinical
trials, molecularly informed trials, and observational
studies.
‘‘(iii) Any other methodologies recommended by the
methodology committee established under paragraph
(6) that are adopted by the Board under paragraph
(9).
‘‘(B) CONTRACTS FOR THE MANAGEMENT OF FUNDING
AND CONDUCT OF RESEARCH.—
‘‘(i) CONTRACTS.—
‘‘(I) IN GENERAL.—In accordance with the
research project agenda established under para-
graph (1)(B), the Institute shall enter into con-
tracts for the management of funding and conduct
of research in accordance with the following:
‘‘(aa) Appropriate agencies and instrumen-
talities of the Federal Government.
‘‘(bb) Appropriate academic research, pri-
vate sector research, or study-conducting enti-
ties.
‘‘(II) PREFERENCE.—In entering into contracts
under subclause (I), the Institute shall give pref-
erence to the Agency for Healthcare Research and
Quality and the National Institutes of Health, but
only if the research to be conducted or managed
under such contract is authorized by the governing
statutes of such Agency or Institutes.
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22 LEARNING WHAT WORKS
124 STAT. 730 PUBLIC LAW 111–148—MAR. 23, 2010
‘‘(ii) CONDITIONS FOR CONTRACTS.—A contract
entered into under this subparagraph shall require
that the agency, instrumentality, or other entity—
‘‘(I) abide by the transparency and conflicts
of interest requirements under subsection (h) that
apply to the Institute with respect to the research
managed or conducted under such contract;
‘‘(II) comply with the methodological standards
adopted under paragraph (9) with respect to such
research;
‘‘(III) consult with the expert advisory panels
for clinical trials and rare disease appointed under
clauses (ii) and (iii), respectively, of paragraph
(4)(A);
‘‘(IV) subject to clause (iv), permit a researcher
who conducts original research under the contract
for the agency, instrumentality, or other entity
to have such research published in a peer-reviewed
journal or other publication;
‘‘(V) have appropriate processes in place to
manage data privacy and meet ethical standards
for the research;
‘‘(VI) comply with the requirements of the
Institute for making the information available to
the public under paragraph (8); and
‘‘(VII) comply with other terms and conditions
determined necessary by the Institute to carry out
the research agenda adopted under paragraph (2).
‘‘(iii) COVERAGE OF COPAYMENTS OR COINSUR-
ANCE.—A contract entered into under this subpara-
graph may allow for the coverage of copayments or
coinsurance, or allow for other appropriate measures,
to the extent that such coverage or other measures
are necessary to preserve the validity of a research
project, such as in the case where the research project
must be blinded.
‘‘(iv) REQUIREMENTS FOR PUBLICATION OF
RESEARCH.—Any research published under clause
(ii)(IV) shall be within the bounds of and entirely con-
sistent with the evidence and findings produced under
the contract with the Institute under this subpara-
graph. If the Institute determines that those require-
ments are not met, the Institute shall not enter into
another contract with the agency, instrumentality, or
entity which managed or conducted such research for
a period determined appropriate by the Institute (but
not less than 5 years).
‘‘(C) REVIEW AND UPDATE OF EVIDENCE.—The Institute
shall review and update evidence on a periodic basis as
appropriate.
‘‘(D) TAKING INTO ACCOUNT POTENTIAL DIFFERENCES.—
Research shall be designed, as appropriate, to take into
account the potential for differences in the effectiveness
of health care treatments, services, and items as used
with various subpopulations, such as racial and ethnic
minorities, women, age, and groups of individuals with
different comorbidities, genetic and molecular sub-types,
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2
APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 731
or quality of life preferences and include members of such
subpopulations as subjects in the research as feasible and
appropriate.
‘‘(E) DIFFERENCES IN TREATMENT MODALITIES.—
Research shall be designed, as appropriate, to take into
account different characteristics of treatment modalities
that may affect research outcomes, such as the phase of
the treatment modality in the innovation cycle and the
impact of the skill of the operator of the treatment
modality.
‘‘(3) DATA COLLECTION.—
‘‘(A) IN GENERAL.—The Secretary shall, with appro-
priate safeguards for privacy, make available to the
Institute such data collected by the Centers for Medicare
& Medicaid Services under the programs under titles XVIII,
XIX, and XXI, as well as provide access to the data net-
works developed under section 937(f) of the Public Health
Service Act, as the Institute and its contractors may require
to carry out this section. The Institute may also request
and obtain data from Federal, State, or private entities,
including data from clinical databases and registries.
‘‘(B) USE OF DATA.—The Institute shall only use data
provided to the Institute under subparagraph (A) in accord-
ance with laws and regulations governing the release and
use of such data, including applicable confidentiality and
privacy standards.
‘‘(4) APPOINTING EXPERT ADVISORY PANELS.—
‘‘(A) APPOINTMENT.—
‘‘(i) IN GENERAL.—The Institute may appoint
permanent or ad hoc expert advisory panels as deter-
mined appropriate to assist in identifying research
priorities and establishing the research project agenda
under paragraph (1) and for other purposes.
‘‘(ii) EXPERT ADVISORY PANELS FOR CLINICAL
TRIALS.—The Institute shall appoint expert advisory
panels in carrying out randomized clinical trials under
the research project agenda under paragraph (2)(A)(ii).
Such expert advisory panels shall advise the Institute
and the agency, instrumentality, or entity conducting
the research on the research question involved and
the research design or protocol, including important
patient subgroups and other parameters of the
research. Such panels shall be available as a resource
for technical questions that may arise during the con-
duct of such research.
‘‘(iii) EXPERT ADVISORY PANEL FOR RARE DISEASE.—
In the case of a research study for rare disease, the
Institute shall appoint an expert advisory panel for
purposes of assisting in the design of the research
study and determining the relative value and feasi-
bility of conducting the research study.
‘‘(B) COMPOSITION.—An expert advisory panel
appointed under subparagraph (A) shall include representa-
tives of practicing and research clinicians, patients, and
experts in scientific and health services research, health
services delivery, and evidence-based medicine who have
experience in the relevant topic, and as appropriate, experts
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2 LEARNING WHAT WORKS
124 STAT. 732 PUBLIC LAW 111–148—MAR. 23, 2010
in integrative health and primary prevention strategies.
The Institute may include a technical expert of each manu-
facturer or each medical technology that is included under
the relevant topic, project, or category for which the panel
is established.
‘‘(5) SUPPORTING PATIENT AND CONSUMER REPRESENTA-
TIVES.—The Institute shall provide support and resources to
help patient and consumer representatives effectively partici-
pate on the Board and expert advisory panels appointed by
the Institute under paragraph (4).
‘‘(6) ESTABLISHING METHODOLOGY COMMITTEE.—
‘‘(A) IN GENERAL.—The Institute shall establish a
standing methodology committee to carry out the functions
described in subparagraph (C).
‘‘(B) APPOINTMENT AND COMPOSITION.—The method-
ology committee established under subparagraph (A) shall
be composed of not more than 15 members appointed by
the Comptroller General of the United States. Members
appointed to the methodology committee shall be experts
in their scientific field, such as health services research,
clinical research, comparative clinical effectiveness
research, biostatistics, genomics, and research methodolo-
gies. Stakeholders with such expertise may be appointed
to the methodology committee. In addition to the members
appointed under the first sentence, the Directors of the
National Institutes of Health and the Agency for
Healthcare Research and Quality (or their designees) shall
each be included as members of the methodology com-
mittee.
‘‘(C) FUNCTIONS.—Subject to subparagraph (D), the
Deadline.
methodology committee shall work to develop and improve
the science and methods of comparative clinical effective-
ness research by, not later than 18 months after the
establishment of the Institute, directly or through sub-
contract, developing and periodically updating the fol-
lowing:
‘‘(i) Methodological standards for research. Such
methodological standards shall provide specific criteria
for internal validity, generalizability, feasibility, and
timeliness of research and for health outcomes meas-
ures, risk adjustment, and other relevant aspects of
research and assessment with respect to the design
of research. Any methodological standards developed
and updated under this subclause shall be scientifically
based and include methods by which new information,
data, or advances in technology are considered and
incorporated into ongoing research projects by the
Institute, as appropriate. The process for developing
and updating such standards shall include input from
relevant experts, stakeholders, and decisionmakers,
and shall provide opportunities for public comment.
Such standards shall also include methods by which
patient subpopulations can be accounted for and evalu-
ated in different types of research. As appropriate,
such standards shall build on existing work on meth-
odological standards for defined categories of health
interventions and for each of the major categories of
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2
APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 733
comparative clinical effectiveness research methods
(determined as of the date of enactment of the Patient
Protection and Affordable Care Act).
‘‘(ii) A translation table that is designed to provide
guidance and act as a reference for the Board to deter-
mine research methods that are most likely to address
each specific research question.
‘‘(D) CONSULTATION AND CONDUCT OF EXAMINATIONS.—
The methodology committee may consult and contract with
the Institute of Medicine of the National Academies and
academic, nonprofit, or other private and governmental
entities with relevant expertise to carry out activities
described in subparagraph (C) and may consult with rel-
evant stakeholders to carry out such activities.
‘‘(E) REPORTS.—The methodology committee shall
submit reports to the Board on the committee’s performance
of the functions described in subparagraph (C). Reports Recommenda-
tions.
shall contain recommendations for the Institute to adopt
methodological standards developed and updated by the
methodology committee as well as other actions deemed
necessary to comply with such methodological standards.
‘‘(7) PROVIDING FOR A PEER-REVIEW PROCESS FOR PRIMARY
RESEARCH.—
‘‘(A) IN GENERAL.—The Institute shall ensure that there
is a process for peer review of primary research described
in subparagraph (A)(ii) of paragraph (2) that is conducted
under such paragraph. Under such process—
‘‘(i) evidence from such primary research shall be
reviewed to assess scientific integrity and adherence
to methodological standards adopted under paragraph
(9); and
‘‘(ii) a list of the names of individuals contributing Lists.
Public
to any peer-review process during the preceding year
information.
or years shall be made public and included in annual
reports in accordance with paragraph (10)(D).
‘‘(B) COMPOSITION.—Such peer-review process shall be
designed in a manner so as to avoid bias and conflicts
of interest on the part of the reviewers and shall be com-
posed of experts in the scientific field relevant to the
research under review.
‘‘(C) USE OF EXISTING PROCESSES.—
‘‘(i) PROCESSES OF ANOTHER ENTITY.—In the case
where the Institute enters into a contract or other
agreement with another entity for the conduct or
management of research under this section, the
Institute may utilize the peer-review process of such
entity if such process meets the requirements under
subparagraphs (A) and (B).
‘‘(ii) PROCESSES OF APPROPRIATE MEDICAL JOUR-
NALS.—The Institute may utilize the peer-review
process of appropriate medical journals if such process
meets the requirements under subparagraphs (A) and
(B).
‘‘(8) RELEASE OF RESEARCH FINDINGS.—
‘‘(A) IN GENERAL.—The Institute shall, not later than Deadline.
90 days after the conduct or receipt of research findings
under this part, make such research findings available
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2 LEARNING WHAT WORKS
124 STAT. 734 PUBLIC LAW 111–148—MAR. 23, 2010
to clinicians, patients, and the general public. The Institute
shall ensure that the research findings—
‘‘(i) convey the findings of research in a manner
that is comprehensible and useful to patients and pro-
viders in making health care decisions;
‘‘(ii) fully convey findings and discuss consider-
ations specific to certain subpopulations, risk factors,
and comorbidities, as appropriate;
‘‘(iii) include limitations of the research and what
further research may be needed as appropriate;
‘‘(iv) not be construed as mandates for practice
guidelines, coverage recommendations, payment, or
policy recommendations; and
‘‘(v) not include any data which would violate the
privacy of research participants or any confidentiality
agreements made with respect to the use of data under
this section.
‘‘(B) DEFINITION OF RESEARCH FINDINGS.—In this para-
graph, the term ‘research findings’ means the results of
a study or assessment.
‘‘(9) ADOPTION.—Subject to subsection (h)(1), the Institute
shall adopt the national priorities identified under paragraph
(1)(A), the research project agenda established under paragraph
(1)(B), the methodological standards developed and updated
by the methodology committee under paragraph (6)(C)(i), and
any peer-review process provided under paragraph (7) by
majority vote. In the case where the Institute does not adopt
such processes in accordance with the preceding sentence, the
processes shall be referred to the appropriate staff or entity
within the Institute (or, in the case of the methodological stand-
ards, the methodology committee) for further review.
‘‘(10) ANNUAL REPORTS.—The Institute shall submit an
Public
information. annual report to Congress and the President, and shall make
the annual report available to the public. Such report shall
contain—
‘‘(A) a description of the activities conducted under
this section, research priorities identified under paragraph
(1)(A) and methodological standards developed and updated
by the methodology committee under paragraph (6)(C)(i)
that are adopted under paragraph (9) during the preceding
year;
‘‘(B) the research project agenda and budget of the
Institute for the following year;
‘‘(C) any administrative activities conducted by the
Institute during the preceding year;
‘‘(D) the names of individuals contributing to any peer-
review process under paragraph (7), without identifying
them with a particular research project; and
‘‘(E) any other relevant information (including informa-
tion on the membership of the Board, expert advisory
panels, methodology committee, and the executive staff
of the Institute, any conflicts of interest with respect to
these individuals, and any bylaws adopted by the Board
during the preceding year).
‘‘(e) ADMINISTRATION.—
‘‘(1) IN GENERAL.—Subject to paragraph (2), the Board shall
carry out the duties of the Institute.
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2
APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 735
‘‘(2) NONDELEGABLE DUTIES.—The activities described in
subsections (d)(1) and (d)(9) are nondelegable.
‘‘(f) BOARD OF GOVERNORS.—
‘‘(1) IN GENERAL.—The Institute shall have a Board of Establishment.
Governors, which shall consist of the following members:
‘‘(A) The Director of Agency for Healthcare Research
and Quality (or the Director’s designee).
‘‘(B) The Director of the National Institutes of Health
(or the Director’s designee).
‘‘(C) Seventeen members appointed, not later than 6 Deadline.
months after the date of enactment of this section, by
the Comptroller General of the United States as follows:
‘‘(i) 3 members representing patients and health
care consumers.
‘‘(ii) 5 members representing physicians and pro-
viders, including at least 1 surgeon, nurse, State-
licensed integrative health care practitioner, and rep-
resentative of a hospital.
‘‘(iii) 3 members representing private payers, of
whom at least 1 member shall represent health insur-
ance issuers and at least 1 member shall represent
employers who self-insure employee benefits.
‘‘(iv) 3 members representing pharmaceutical,
device, and diagnostic manufacturers or developers.
‘‘(v) 1 member representing quality improvement
or independent health service researchers.
‘‘(vi) 2 members representing the Federal Govern-
ment or the States, including at least 1 member rep-
resenting a Federal health program or agency.
‘‘(2) QUALIFICATIONS.—The Board shall represent a broad
range of perspectives and collectively have scientific expertise
in clinical health sciences research, including epidemiology,
decisions sciences, health economics, and statistics. In
appointing the Board, the Comptroller General of the United
States shall consider and disclose any conflicts of interest in
accordance with subsection (h)(4)(B). Members of the Board
shall be recused from relevant Institute activities in the case
where the member (or an immediate family member of such
member) has a real conflict of interest directly related to the
research project or the matter that could affect or be affected
by such participation.
‘‘(3) TERMS; VACANCIES.—A member of the Board shall be
appointed for a term of 6 years, except with respect to the
members first appointed, whose terms of appointment shall
be staggered evenly over 2-year increments. No individual shall
be appointed to the Board for more than 2 terms. Vacancies
shall be filled in the same manner as the original appointment
was made.
‘‘(4) CHAIRPERSON AND VICE-CHAIRPERSON.—The Comp- Designation.
troller General of the United States shall designate a Chair-
person and Vice Chairperson of the Board from among the
members of the Board. Such members shall serve as Chair-
person or Vice Chairperson for a period of 3 years.
‘‘(5) COMPENSATION.—Each member of the Board who is
not an officer or employee of the Federal Government shall
be entitled to compensation (equivalent to the rate provided
for level IV of the Executive Schedule under section 5315 of
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2 LEARNING WHAT WORKS
124 STAT. 736 PUBLIC LAW 111–148—MAR. 23, 2010
title 5, United States Code) and expenses incurred while per-
forming the duties of the Board. An officer or employee of
the Federal government who is a member of the Board shall
be exempt from compensation.
‘‘(6) DIRECTOR AND STAFF; EXPERTS AND CONSULTANTS.—
The Board may employ and fix the compensation of an Execu-
tive Director and such other personnel as may be necessary
to carry out the duties of the Institute and may seek such
assistance and support of, or contract with, experts and consult-
ants that may be necessary for the performance of the duties
of the Institute.
‘‘(7) MEETINGS AND HEARINGS.—The Board shall meet and
hold hearings at the call of the Chairperson or a majority
of its members. Meetings not solely concerning matters of per-
sonnel shall be advertised at least 7 days in advance and
open to the public. A majority of the Board members shall
constitute a quorum, but a lesser number of members may
meet and hold hearings.
‘‘(g) FINANCIAL AND GOVERNMENTAL OVERSIGHT.—
‘‘(1) CONTRACT FOR AUDIT.—The Institute shall provide for
the conduct of financial audits of the Institute on an annual
basis by a private entity with expertise in conducting financial
audits.
‘‘(2) REVIEW AND ANNUAL REPORTS.—
‘‘(A) REVIEW.—The Comptroller General of the United
States shall review the following:
‘‘(i) Not less frequently than on an annual basis,
the financial audits conducted under paragraph (1).
‘‘(ii) Not less frequently than every 5 years, the
processes established by the Institute, including the
research priorities and the conduct of research projects,
in order to determine whether information produced
by such research projects is objective and credible,
is produced in a manner consistent with the require-
ments under this section, and is developed through
a transparent process.
‘‘(iii) Not less frequently than every 5 years, the
dissemination and training activities and data net-
works established under section 937 of the Public
Health Service Act, including the methods and prod-
ucts used to disseminate research, the types of training
conducted and supported, and the types and functions
of the data networks established, in order to determine
whether the activities and data are produced in a
manner consistent with the requirements under such
section.
‘‘(iv) Not less frequently than every 5 years, the
overall effectiveness of activities conducted under this
section and the dissemination, training, and capacity
building activities conducted under section 937 of the
Public Health Service Act. Such review shall include
an analysis of the extent to which research findings
are used by health care decision-makers, the effect
of the dissemination of such findings on reducing prac-
tice variation and disparities in health care, and the
effect of the research conducted and disseminated on
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29
APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 737
innovation and the health care economy of the United
States.
‘‘(v) Not later than 8 years after the date of enact-
ment of this section, the adequacy and use of the
funding for the Institute and the activities conducted
under section 937 of the Public Health Service Act,
including a determination as to whether, based on
the utilization of research findings by public and pri-
vate payers, funding sources for the Patient-Centered
Outcomes Research Trust Fund under section 9511
of the Internal Revenue Code of 1986 are appropriate
and whether such sources of funding should be contin-
ued or adjusted.
‘‘(B) ANNUAL REPORTS.—Not later than April 1 of each Recommenda-
tions.
year, the Comptroller General of the United States shall
submit to Congress a report containing the results of the
review conducted under subparagraph (A) with respect to
the preceding year (or years, if applicable), together with
recommendations for such legislation and administrative
action as the Comptroller General determines appropriate.
‘‘(h) ENSURING TRANSPARENCY, CREDIBILITY, AND ACCESS.—The Procedures.
Institute shall establish procedures to ensure that the following
requirements for ensuring transparency, credibility, and access are
met:
‘‘(1) PUBLIC COMMENT PERIODS.—The Institute shall provide
for a public comment period of not less than 45 days and
not more than 60 days prior to the adoption under subsection
(d)(9) of the national priorities identified under subsection
(d)(1)(A), the research project agenda established under sub-
section (d)(1)(B), the methodological standards developed and
updated by the methodology committee under subsection
(d)(6)(C)(i), and the peer-review process provided under para-
graph (7), and after the release of draft findings with respect
to systematic reviews of existing research and evidence.
‘‘(2) ADDITIONAL FORUMS.—The Institute shall support
forums to increase public awareness and obtain and incorporate
public input and feedback through media (such as an Internet
website) on research priorities, research findings, and other
duties, activities, or processes the Institute determines appro-
priate.
‘‘(3) PUBLIC AVAILABILITY.—The Institute shall make avail- Web posting.
able to the public and disclose through the official public Inter-
net website of the Institute the following:
‘‘(A) Information contained in research findings as
specified in subsection (d)(9).
‘‘(B) The process and methods for the conduct of
research, including the identity of the entity and the inves-
tigators conducing such research and any conflicts of
interests of such parties, any direct or indirect links the
entity has to industry, and research protocols, including
measures taken, methods of research and analysis, research
results, and such other information the Institute deter-
mines appropriate) concurrent with the release of research
findings.
‘‘(C) Notice of public comment periods under paragraph Notice.
(1), including deadlines for public comments.
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0 LEARNING WHAT WORKS
124 STAT. 738 PUBLIC LAW 111–148—MAR. 23, 2010
‘‘(D) Subsequent comments received during each of the
public comment periods.
‘‘(E) In accordance with applicable laws and processes
and as the Institute determines appropriate, proceedings
of the Institute.
‘‘(4) DISCLOSURE OF CONFLICTS OF INTEREST.—
‘‘(A) IN GENERAL.—A conflict of interest shall be dis-
closed in the following manner:
‘‘(i) By the Institute in appointing members to
an expert advisory panel under subsection (d)(4), in
selecting individuals to contribute to any peer-review
process under subsection (d)(7), and for employment
as executive staff of the Institute.
‘‘(ii) By the Comptroller General in appointing
members of the methodology committee under sub-
section (d)(6);
‘‘(iii) By the Institute in the annual report under
subsection (d)(10), except that, in the case of individ-
uals contributing to any such peer review process, such
description shall be in a manner such that those
individuals cannot be identified with a particular
research project.
‘‘(B) MANNER OF DISCLOSURE.—Conflicts of interest
Web posting.
shall be disclosed as described in subparagraph (A) as
soon as practicable on the Internet web site of the Institute
and of the Government Accountability Office. The informa-
tion disclosed under the preceding sentence shall include
the type, nature, and magnitude of the interests of the
individual involved, except to the extent that the individual
recuses himself or herself from participating in the consid-
eration of or any other activity with respect to the study
as to which the potential conflict exists.
‘‘(i) RULES.—The Institute, its Board or staff, shall be prohibited
from accepting gifts, bequeaths, or donations of services or property.
In addition, the Institute shall be prohibited from establishing
a corporation or generating revenues from activities other than
as provided under this section.
‘‘(j) RULES OF CONSTRUCTION.—
‘‘(1) COVERAGE.—Nothing in this section shall be con-
strued—
‘‘(A) to permit the Institute to mandate coverage,
reimbursement, or other policies for any public or private
payer; or
‘‘(B) as preventing the Secretary from covering the
routine costs of clinical care received by an individual enti-
tled to, or enrolled for, benefits under title XVIII, XIX,
or XXI in the case where such individual is participating
in a clinical trial and such costs would otherwise be covered
under such title with respect to the beneficiary.’’.
(b) DISSEMINATION AND BUILDING CAPACITY FOR RESEARCH.—
Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.),
as amended by section 3606, is further amended by inserting after
section 936 the following:
‘‘SEC. 937. DISSEMINATION AND BUILDING CAPACITY FOR RESEARCH.
42 USC 299b–37.
‘‘(a) IN GENERAL.—
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APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 739
‘‘(1) DISSEMINATION.—The Office of Communication and
Knowledge Transfer (referred to in this section as the ‘Office’)
at the Agency for Healthcare Research and Quality (or any
other relevant office designated by Agency for Healthcare
Research and Quality), in consultation with the National
Institutes of Health, shall broadly disseminate the research
findings that are published by the Patient Centered Outcomes
Research Institute established under section 1181(b) of the
Social Security Act (referred to in this section as the ‘Institute’)
and other government-funded research relevant to comparative
clinical effectiveness research. The Office shall create informa-
tional tools that organize and disseminate research findings
for physicians, health care providers, patients, payers, and
policy makers. The Office shall also develop a publicly available Public
resource database that collects and contains government-funded information.
evidence and research from public, private, not-for profit, and
academic sources.
‘‘(2) REQUIREMENTS.—The Office shall provide for the
dissemination of the Institute’s research findings and govern-
ment-funded research relevant to comparative clinical effective-
ness research to physicians, health care providers, patients,
vendors of health information technology focused on clinical
decision support, appropriate professional associations, and
Federal and private health plans. Materials, forums, and media
used to disseminate the findings, informational tools, and
resource databases shall—
‘‘(A) include a description of considerations for specific
subpopulations, the research methodology, and the limita-
tions of the research, and the names of the entities, agen-
cies, instrumentalities, and individuals who conducted any
research which was published by the Institute; and
‘‘(B) not be construed as mandates, guidelines, or rec-
ommendations for payment, coverage, or treatment.
‘‘(b) INCORPORATION OF RESEARCH FINDINGS.—The Office, in
consultation with relevant medical and clinical associations, shall
assist users of health information technology focused on clinical
decision support to promote the timely incorporation of research
findings disseminated under subsection (a) into clinical practices
and to promote the ease of use of such incorporation.
‘‘(c) FEEDBACK.—The Office shall establish a process to receive
feedback from physicians, health care providers, patients, and ven-
dors of health information technology focused on clinical decision
support, appropriate professional associations, and Federal and pri-
vate health plans about the value of the information disseminated
and the assistance provided under this section.
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this section shall
preclude the Institute from making its research findings publicly
available as required under section 1181(d)(8) of the Social Security
Act.
‘‘(e) TRAINING OF RESEARCHERS.—The Agency for Health Care
Research and Quality, in consultation with the National Institutes
of Health, shall build capacity for comparative clinical effectiveness
research by establishing a grant program that provides for the
training of researchers in the methods used to conduct such
research, including systematic reviews of existing research and
primary research such as clinical trials. At a minimum, such
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2 LEARNING WHAT WORKS
124 STAT. 740 PUBLIC LAW 111–148—MAR. 23, 2010
training shall be in methods that meet the methodological standards
adopted under section 1181(d)(9) of the Social Security Act.
‘‘(f) BUILDING DATA FOR RESEARCH.—The Secretary shall pro-
vide for the coordination of relevant Federal health programs to
build data capacity for comparative clinical effectiveness research,
including the development and use of clinical registries and health
outcomes research data networks, in order to develop and maintain
a comprehensive, interoperable data network to collect, link, and
analyze data on outcomes and effectiveness from multiple sources,
including electronic health records.
‘‘(g) AUTHORITY TO CONTRACT WITH THE INSTITUTE.—Agencies
and instrumentalities of the Federal Government may enter into
agreements with the Institute, and accept and retain funds, for
the conduct and support of research described in this part, provided
that the research to be conducted or supported under such agree-
ments is authorized under the governing statutes of such agencies
and instrumentalities.’’.
(c) IN GENERAL.—Part D of title XI of the Social Security
Act, as added by subsection (a), is amended by adding at the
end the following new section:
‘‘LIMITATIONS ON CERTAIN USES OF COMPARATIVE CLINICAL
EFFECTIVENESS RESEARCH
‘‘SEC. 1182. (a) The Secretary may only use evidence and
42 USC 1320e–1.
findings from research conducted under section 1181 to make a
determination regarding coverage under title XVIII if such use
is through an iterative and transparent process which includes
public comment and considers the effect on subpopulations.
‘‘(b) Nothing in section 1181 shall be construed as—
‘‘(1) superceding or modifying the coverage of items or
services under title XVIII that the Secretary determines are
reasonable and necessary under section 1862(l)(1); or
‘‘(2) authorizing the Secretary to deny coverage of items
or services under such title solely on the basis of comparative
clinical effectiveness research.
‘‘(c)(1) The Secretary shall not use evidence or findings from
comparative clinical effectiveness research conducted under section
1181 in determining coverage, reimbursement, or incentive pro-
grams under title XVIII in a manner that treats extending the
life of an elderly, disabled, or terminally ill individual as of lower
value than extending the life of an individual who is younger,
nondisabled, or not terminally ill.
‘‘(2) Paragraph (1) shall not be construed as preventing the
Secretary from using evidence or findings from such comparative
clinical effectiveness research in determining coverage, reimburse-
ment, or incentive programs under title XVIII based upon a
comparison of the difference in the effectiveness of alternative treat-
ments in extending an individual’s life due to the individual’s age,
disability, or terminal illness.
‘‘(d)(1) The Secretary shall not use evidence or findings from
comparative clinical effectiveness research conducted under section
1181 in determining coverage, reimbursement, or incentive pro-
grams under title XVIII in a manner that precludes, or with the
intent to discourage, an individual from choosing a health care
treatment based on how the individual values the tradeoff between
extending the length of their life and the risk of disability.
‘‘(2)(A) Paragraph (1) shall not be construed to—
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APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 741
‘‘(i) limit the application of differential copayments under
title XVIII based on factors such as cost or type of service;
or
‘‘(ii) prevent the Secretary from using evidence or findings
from such comparative clinical effectiveness research in deter-
mining coverage, reimbursement, or incentive programs under
such title based upon a comparison of the difference in the
effectiveness of alternative health care treatments in extending
an individual’s life due to that individual’s age, disability, or
terminal illness.
‘‘(3) Nothing in the provisions of, or amendments made by
the Patient Protection and Affordable Care Act, shall be construed
to limit comparative clinical effectiveness research or any other
research, evaluation, or dissemination of information concerning
the likelihood that a health care treatment will result in disability.
‘‘(e) The Patient-Centered Outcomes Research Institute estab-
lished under section 1181(b)(1) shall not develop or employ a dollars-
per-quality adjusted life year (or similar measure that discounts
the value of a life because of an individual’s disability) as a
threshold to establish what type of health care is cost effective
or recommended. The Secretary shall not utilize such an adjusted
life year (or such a similar measure) as a threshold to determine
coverage, reimbursement, or incentive programs under title XVIII.’’.
(d) IN GENERAL.—Part D of title XI of the Social Security
Act, as added by subsection (a) and amended by subsection (c),
is amended by adding at the end the following new section:
‘‘TRUST FUND TRANSFERS TO PATIENT-CENTERED OUTCOMES
RESEARCH TRUST FUND
‘‘SEC. 1183. (a) IN GENERAL.—The Secretary shall provide for 42 USC 1320e–2.
the transfer, from the Federal Hospital Insurance Trust Fund under
section 1817 and the Federal Supplementary Medical Insurance
Trust Fund under section 1841, in proportion (as estimated by
the Secretary) to the total expenditures during such fiscal year
that are made under title XVIII from the respective trust fund,
to the Patient-Centered Outcomes Research Trust Fund (referred
to in this section as the ‘PCORTF’) under section 9511 of the
Internal Revenue Code of 1986, of the following:
‘‘(1) For fiscal year 2013, an amount equal to $1 multiplied
by the average number of individuals entitled to benefits under
part A, or enrolled under part B, of title XVIII during such
fiscal year.
‘‘(2) For each of fiscal years 2014, 2015, 2016, 2017, 2018,
and 2019, an amount equal to $2 multiplied by the average
number of individuals entitled to benefits under part A, or
enrolled under part B, of title XVIII during such fiscal year.
‘‘(b) ADJUSTMENTS FOR INCREASES IN HEALTH CARE SPENDING.—
In the case of any fiscal year beginning after September 30, 2014,
the dollar amount in effect under subsection (a)(2) for such fiscal
year shall be equal to the sum of such dollar amount for the
previous fiscal year (determined after the application of this sub-
section), plus an amount equal to the product of—
‘‘(1) such dollar amount for the previous fiscal year, multi-
plied by
‘‘(2) the percentage increase in the projected per capita
amount of National Health Expenditures, as most recently pub-
lished by the Secretary before the beginning of the fiscal year.’’.
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LEARNING WHAT WORKS
124 STAT. 742 PUBLIC LAW 111–148—MAR. 23, 2010
(e) PATIENT-CENTERED OUTCOMES RESEARCH TRUST FUND;
FINANCING FOR TRUST FUND.—
(1) ESTABLISHMENT OF TRUST FUND.—
(A) IN GENERAL.—Subchapter A of chapter 98 of the
Internal Revenue Code of 1986 (relating to establishment
of trust funds) is amended by adding at the end the fol-
lowing new section:
‘‘SEC. 9511. PATIENT-CENTERED OUTCOMES RESEARCH TRUST FUND.
26 USC 9511.
‘‘(a) CREATION OF TRUST FUND.—There is established in the
Treasury of the United States a trust fund to be known as the
‘Patient-Centered Outcomes Research Trust Fund’ (hereafter in this
section referred to as the ‘PCORTF’), consisting of such amounts
as may be appropriated or credited to such Trust Fund as provided
in this section and section 9602(b).
‘‘(b) TRANSFERS TO FUND.—
‘‘(1) APPROPRIATION.—There are hereby appropriated to the
Trust Fund the following:
‘‘(A) For fiscal year 2010, $10,000,000.
‘‘(B) For fiscal year 2011, $50,000,000.
‘‘(C) For fiscal year 2012, $150,000,000.
‘‘(D) For fiscal year 2013—
‘‘(i) an amount equivalent to the net revenues
received in the Treasury from the fees imposed under
subchapter B of chapter 34 (relating to fees on health
insurance and self-insured plans) for such fiscal year;
and
‘‘(ii) $150,000,000.
‘‘(E) For each of fiscal years 2014, 2015, 2016, 2017,
2018, and 2019—
‘‘(i) an amount equivalent to the net revenues
received in the Treasury from the fees imposed under
subchapter B of chapter 34 (relating to fees on health
insurance and self-insured plans) for such fiscal year;
and
‘‘(ii) $150,000,000.
The amounts appropriated under subparagraphs (A), (B),
(C), (D)(ii), and (E)(ii) shall be transferred from the general
fund of the Treasury, from funds not otherwise appro-
priated.
‘‘(2) TRUST FUND TRANSFERS.—In addition to the amounts
appropriated under paragraph (1), there shall be credited to
the PCORTF the amounts transferred under section 1183 of
the Social Security Act.
‘‘(3) LIMITATION ON TRANSFERS TO PCORTF.—No amount
may be appropriated or transferred to the PCORTF on and
after the date of any expenditure from the PCORTF which
is not an expenditure permitted under this section. The deter-
mination of whether an expenditure is so permitted shall be
made without regard to—
‘‘(A) any provision of law which is not contained or
referenced in this chapter or in a revenue Act, and
‘‘(B) whether such provision of law is a subsequently
enacted provision or directly or indirectly seeks to waive
the application of this paragraph.
‘‘(c) TRUSTEE.—The Secretary of the Treasury shall be a trustee
of the PCORTF.
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APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 743
‘‘(d) EXPENDITURES FROM FUND.—
‘‘(1) AMOUNTS AVAILABLE TO THE PATIENT-CENTERED OUT-
COMES RESEARCH INSTITUTE.—Subject to paragraph (2),
amounts in the PCORTF are available, without further appro-
priation, to the Patient-Centered Outcomes Research Institute
established under section 1181(b) of the Social Security Act
for carrying out part D of title XI of the Social Security Act
(as in effect on the date of enactment of such Act).
‘‘(2) TRANSFER OF FUNDS.—
‘‘(A) IN GENERAL.—The trustee of the PCORTF shall
provide for the transfer from the PCORTF of 20 percent
of the amounts appropriated or credited to the PCORTF
for each of fiscal years 2011 through 2019 to the Secretary
of Health and Human Services to carry out section 937
of the Public Health Service Act.
‘‘(B) AVAILABILITY.—Amounts transferred under
subparagraph (A) shall remain available until expended.
‘‘(C) REQUIREMENTS.—Of the amounts transferred
under subparagraph (A) with respect to a fiscal year, the
Secretary of Health and Human Services shall distribute—
‘‘(i) 80 percent to the Office of Communication
and Knowledge Transfer of the Agency for Healthcare
Research and Quality (or any other relevant office
designated by Agency for Healthcare Research and
Quality) to carry out the activities described in section
937 of the Public Health Service Act; and
‘‘(ii) 20 percent to the Secretary to carry out the
activities described in such section 937.
‘‘(e) NET REVENUES.—For purposes of this section, the term Definition.
‘net revenues’ means the amount estimated by the Secretary of
the Treasury based on the excess of—
‘‘(1) the fees received in the Treasury under subchapter
B of chapter 34, over
‘‘(2) the decrease in the tax imposed by chapter 1 resulting
from the fees imposed by such subchapter.
‘‘(f) TERMINATION.—No amounts shall be available for expendi-
ture from the PCORTF after September 30, 2019, and any amounts
in such Trust Fund after such date shall be transferred to the
general fund of the Treasury.’’.
(B) CLERICAL AMENDMENT.—The table of sections for
subchapter A of chapter 98 of such Code is amended by
adding at the end the following new item:
‘‘Sec. 9511. Patient-centered outcomes research trust fund.’’.
(2) FINANCING FOR FUND FROM FEES ON INSURED AND SELF-
INSURED HEALTH PLANS.—
(A) GENERAL RULE.—Chapter 34 of the Internal Rev-
enue Code of 1986 is amended by adding at the end the
following new subchapter:
‘‘Subchapter B—Insured and Self-Insured Health Plans
‘‘Sec. 4375. Health insurance.
‘‘Sec. 4376. Self-insured health plans.
‘‘Sec. 4377. Definitions and special rules.
‘‘SEC. 4375. HEALTH INSURANCE. 26 USC 4375.
‘‘(a) IMPOSITION OF FEE.—There is hereby imposed on each
specified health insurance policy for each policy year ending after
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LEARNING WHAT WORKS
124 STAT. 744 PUBLIC LAW 111–148—MAR. 23, 2010
September 30, 2012, a fee equal to the product of $2 ($1 in the
case of policy years ending during fiscal year 2013) multiplied
by the average number of lives covered under the policy.
‘‘(b) LIABILITY FOR FEE.—The fee imposed by subsection (a)
shall be paid by the issuer of the policy.
‘‘(c) SPECIFIED HEALTH INSURANCE POLICY.—For purposes of
this section:
‘‘(1) IN GENERAL.—Except as otherwise provided in this
Definition.
section, the term ‘specified health insurance policy’ means any
accident or health insurance policy (including a policy under
a group health plan) issued with respect to individuals residing
in the United States.
‘‘(2) EXEMPTION FOR CERTAIN POLICIES.—The term ‘specified
health insurance policy’ does not include any insurance if
substantially all of its coverage is of excepted benefits described
in section 9832(c).
‘‘(3) TREATMENT OF PREPAID HEALTH COVERAGE ARRANGE-
MENTS.—
‘‘(A) IN GENERAL.—In the case of any arrangement
described in subparagraph (B), such arrangement shall
be treated as a specified health insurance policy, and the
person referred to in such subparagraph shall be treated
as the issuer.
‘‘(B) DESCRIPTION OF ARRANGEMENTS.—An arrange-
ment is described in this subparagraph if under such
arrangement fixed payments or premiums are received as
consideration for any person’s agreement to provide or
arrange for the provision of accident or health coverage
to residents of the United States, regardless of how such
coverage is provided or arranged to be provided.
‘‘(d) ADJUSTMENTS FOR INCREASES IN HEALTH CARE
SPENDING.—In the case of any policy year ending in any fiscal
year beginning after September 30, 2014, the dollar amount in
effect under subsection (a) for such policy year shall be equal
to the sum of such dollar amount for policy years ending in the
previous fiscal year (determined after the application of this sub-
section), plus an amount equal to the product of—
‘‘(1) such dollar amount for policy years ending in the
previous fiscal year, multiplied by
‘‘(2) the percentage increase in the projected per capita
amount of National Health Expenditures, as most recently pub-
lished by the Secretary before the beginning of the fiscal year.
‘‘(e) TERMINATION.—This section shall not apply to policy years
ending after September 30, 2019.
‘‘SEC. 4376. SELF-INSURED HEALTH PLANS.
26 USC 4376.
‘‘(a) IMPOSITION OF FEE.—In the case of any applicable self-
insured health plan for each plan year ending after September
30, 2012, there is hereby imposed a fee equal to $2 ($1 in the
case of plan years ending during fiscal year 2013) multiplied by
the average number of lives covered under the plan.
‘‘(b) LIABILITY FOR FEE.—
‘‘(1) IN GENERAL.—The fee imposed by subsection (a) shall
be paid by the plan sponsor.
‘‘(2) PLAN SPONSOR.—For purposes of paragraph (1) the
Definition.
term ‘plan sponsor’ means—
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APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 745
‘‘(A) the employer in the case of a plan established
or maintained by a single employer,
‘‘(B) the employee organization in the case of a plan
established or maintained by an employee organization,
‘‘(C) in the case of—
‘‘(i) a plan established or maintained by 2 or more
employers or jointly by 1 or more employers and 1
or more employee organizations,
‘‘(ii) a multiple employer welfare arrangement, or
‘‘(iii) a voluntary employees’ beneficiary association
described in section 501(c)(9), the association, com-
mittee, joint board of trustees, or other similar group
of representatives of the parties who establish or main-
tain the plan, or
‘‘(D) the cooperative or association described in sub-
section (c)(2)(F) in the case of a plan established or main-
tained by such a cooperative or association.
‘‘(c) APPLICABLE SELF-INSURED HEALTH PLAN.—For purposes Definition.
of this section, the term ‘applicable self-insured health plan’ means
any plan for providing accident or health coverage if—
‘‘(1) any portion of such coverage is provided other than
through an insurance policy, and
‘‘(2) such plan is established or maintained—
‘‘(A) by 1 or more employers for the benefit of their
employees or former employees,
‘‘(B) by 1 or more employee organizations for the benefit
of their members or former members,
‘‘(C) jointly by 1 or more employers and 1 or more
employee organizations for the benefit of employees or
former employees,
‘‘(D) by a voluntary employees’ beneficiary association
described in section 501(c)(9),
‘‘(E) by any organization described in section 501(c)(6),
or
‘‘(F) in the case of a plan not described in the preceding
subparagraphs, by a multiple employer welfare arrange-
ment (as defined in section 3(40) of Employee Retirement
Income Security Act of 1974), a rural electric cooperative
(as defined in section 3(40)(B)(iv) of such Act), or a rural
telephone cooperative association (as defined in section
3(40)(B)(v) of such Act).
‘‘(d) ADJUSTMENTS FOR INCREASES IN HEALTH CARE
SPENDING.—In the case of any plan year ending in any fiscal
year beginning after September 30, 2014, the dollar amount in
effect under subsection (a) for such plan year shall be equal to
the sum of such dollar amount for plan years ending in the previous
fiscal year (determined after the application of this subsection),
plus an amount equal to the product of—
‘‘(1) such dollar amount for plan years ending in the pre-
vious fiscal year, multiplied by
‘‘(2) the percentage increase in the projected per capita
amount of National Health Expenditures, as most recently pub-
lished by the Secretary before the beginning of the fiscal year.
‘‘(e) TERMINATION.—This section shall not apply to plan years
ending after September 30, 2019.
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LEARNING WHAT WORKS
124 STAT. 746 PUBLIC LAW 111–148—MAR. 23, 2010
‘‘SEC. 4377. DEFINITIONS AND SPECIAL RULES.
26 USC 4377.
‘‘(a) DEFINITIONS.—For purposes of this subchapter—
‘‘(1) ACCIDENT AND HEALTH COVERAGE.—The term ‘accident
and health coverage’ means any coverage which, if provided
by an insurance policy, would cause such policy to be a specified
health insurance policy (as defined in section 4375(c)).
‘‘(2) INSURANCE POLICY.—The term ‘insurance policy’ means
any policy or other instrument whereby a contract of insurance
is issued, renewed, or extended.
‘‘(3) UNITED STATES.—The term ‘United States’ includes
any possession of the United States.
‘‘(b) TREATMENT OF GOVERNMENTAL ENTITIES.—
‘‘(1) IN GENERAL.—For purposes of this subchapter—
‘‘(A) the term ‘person’ includes any governmental
entity, and
‘‘(B) notwithstanding any other law or rule of law,
governmental entities shall not be exempt from the fees
imposed by this subchapter except as provided in paragraph
(2).
‘‘(2) TREATMENT OF EXEMPT GOVERNMENTAL PROGRAMS.—
In the case of an exempt governmental program, no fee shall
be imposed under section 4375 or section 4376 on any covered
life under such program.
‘‘(3) EXEMPT GOVERNMENTAL PROGRAM DEFINED.—For pur-
poses of this subchapter, the term ‘exempt governmental pro-
gram’ means—
‘‘(A) any insurance program established under title
XVIII of the Social Security Act,
‘‘(B) the medical assistance program established by
title XIX or XXI of the Social Security Act,
‘‘(C) any program established by Federal law for pro-
viding medical care (other than through insurance policies)
to individuals (or the spouses and dependents thereof) by
reason of such individuals being members of the Armed
Forces of the United States or veterans, and
‘‘(D) any program established by Federal law for pro-
viding medical care (other than through insurance policies)
to members of Indian tribes (as defined in section 4(d)
of the Indian Health Care Improvement Act).
‘‘(c) TREATMENT AS TAX.—For purposes of subtitle F, the fees
imposed by this subchapter shall be treated as if they were taxes.
‘‘(d) NO COVER OVER TO POSSESSIONS.—Notwithstanding any
other provision of law, no amount collected under this subchapter
shall be covered over to any possession of the United States.’’.
(B) CLERICAL AMENDMENTS.—
(i) Chapter 34 of such Code is amended by striking
the chapter heading and inserting the following:
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9
APPENDIX E
PUBLIC LAW 111–148—MAR. 23, 2010 124 STAT. 747
‘‘CHAPTER 34—TAXES ON CERTAIN INSURANCE
POLICIES
‘‘SUBCHAPTER A. POLICIES ISSUED BY FOREIGN INSURERS
‘‘SUBCHAPTER B. INSURED AND SELF-INSURED HEALTH PLANS
‘‘Subchapter A—Policies Issued By Foreign Insurers’’.
(ii) The table of chapters for subtitle D of such
Code is amended by striking the item relating to
chapter 34 and inserting the following new item:
‘‘CHAPTER 34—TAXES CERTAIN INSURANCE POLICIES’’.
ON
(f) TAX-EXEMPT STATUS OF THE PATIENT-CENTERED OUTCOMES
RESEARCH INSTITUTE.—Subsection 501(l) of the Internal Revenue
Code of 1986 is amended by adding at the end the following new 26 USC 501.
paragraph:
‘‘(4) The Patient-Centered Outcomes Research Institute
established under section 1181(b) of the Social Security Act.’’.
SEC. 6302. FEDERAL COORDINATING COUNCIL FOR COMPARATIVE 42 USC 2996–8
note.
EFFECTIVENESS RESEARCH.
Notwithstanding any other provision of law, the Federal Coordi- Termination
date.
nating Council for Comparative Effectiveness Research established
under section 804 of Division A of the American Recovery and
Reinvestment Act of 2009 (42 U.S.C. 299b–8), including the require-
ment under subsection (e)(2) of such section, shall terminate on
the date of enactment of this Act.
Subtitle E—Medicare, Medicaid, and CHIP
Program Integrity Provisions
SEC. 6401. PROVIDER SCREENING AND OTHER ENROLLMENT REQUIRE-
MENTS UNDER MEDICARE, MEDICAID, AND CHIP.
(a) MEDICARE.—Section 1866(j) of the Social Security Act (42
U.S.C. 1395cc(j)) is amended—
(1) in paragraph (1)(A), by adding at the end the following:
‘‘Such process shall include screening of providers and suppliers
in accordance with paragraph (2), a provisional period of
enhanced oversight in accordance with paragraph (3), disclosure
requirements in accordance with paragraph (4), the imposition
of temporary enrollment moratoria in accordance with para-
graph (5), and the establishment of compliance programs in
accordance with paragraph (6).’’;
(2) by redesignating paragraph (2) as paragraph (7); and
(3) by inserting after paragraph (1) the following:
‘‘(2) PROVIDER SCREENING.—
‘‘(A) PROCEDURES.—Not later than 180 days after the Deadline.
date of enactment of this paragraph, the Secretary, in
consultation with the Inspector General of the Department
of Health and Human Services, shall establish procedures
under which screening is conducted with respect to pro-
viders of medical or other items or services and suppliers
under the program under this title, the Medicaid program
under title XIX, and the CHIP program under title XXI.
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