I 
111TH CONGRESS 
1ST SESSION H. R. 2502 
To amend title XI of the Social Security Act to provide for the conduct 
of comparative effectiveness research and to amend the Internal Revenue 
Code of 1986 to establish a Comparative Effectiveness Research Trust 
Fund, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2009 
Mr. SCHRADER (for himself, Mr. MCMAHON, Mr. CONNOLLY of Virginia, Mr. 
KIND, Mrs. HALVORSON, Mr. CROWLEY, Ms. SCHWARTZ, Mr. HIMES, 
Mr. ALTMIRE, Ms. BEAN, Mrs. TAUSCHER, and Mrs. DAVIS of Cali-
fornia) introduced the following bill; which was referred to the Committee 
on Ways and Means, and in addition to the Committee on Energy and 
Commerce, for a period to be subsequently determined by the Speaker, 
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned 
A BILL 
To amend title XI of the Social Security Act to provide 
for the conduct of comparative effectiveness research and 
to amend the Internal Revenue Code of 1986 to establish 
a Comparative Effectiveness Research Trust Fund, and 
for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Comparative Effective-
ness Research Act of 2009’’. 
SEC. 2. COMPARATIVE EFFECTIVENESS 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 EFFECTIVENESS RESEARCH 
‘‘COMPARATIVE EFFECTIVENESS RESEARCH 
‘‘SEC. 1181. (a) DEFINITIONS.—In this section: 
‘‘(1) BOARD.—The term ‘Board’ means the 
Board of Governors established under subsection (f). 
‘‘(2) COMPARATIVE CLINICAL EFFECTIVENESS 
RESEARCH.— 
‘‘(A) IN GENERAL.—The term ‘compara-
tive clinical effectiveness research’ means re-
search evaluating and comparing the clinical ef-
fectiveness, risks, and benefits of 2 or more 
medical treatments, services, and items de-
scribed in subparagraph (B). 
‘‘(B) MEDICAL
TREATMENTS, SERVICES, 
AND
ITEMS
DESCRIBED.—The medical treat-
ments, services, and items described in this sub-
paragraph are health care interventions, proto-
cols for treatment, procedures, medical devices, 
diagnostic tools, pharmaceuticals (including 
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drugs and biologicals), and any other processes 
or items being used in the treatment and diag-
nosis of, or prevention of illness or injury in, 
patients. 
‘‘(3) 
COMPARATIVE
EFFECTIVENESS
RE-
SEARCH.—The term ‘comparative effectiveness re-
search’ means research evaluating and comparing 
the implications and outcomes of 2 or more health 
care strategies to address a particular medical condi-
tion. 
‘‘(4) CONFLICTS
OF
INTEREST.—The term 
‘conflicts of interest’ means associations, including 
financial and personal, that may be reasonably as-
sumed to have the potential to bias an individual’s 
decisions in matters related to the Institute or the 
conduct of activities under this section. 
‘‘(5) INSTITUTE.—The term ‘Institute’ means 
the ‘Health Care Comparative Effectiveness Re-
search Institute’ established under subsection (b)(1). 
‘‘(b) HEALTH CARE COMPARATIVE EFFECTIVENESS 
RESEARCH INSTITUTE.— 
‘‘(1) ESTABLISHMENT.—There is authorized to 
be established a nonprofit corporation, to be known 
as the ‘‘Health Care Comparative Effectiveness Re-
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search Institute’’ which is neither an agency nor es-
tablishment of the United States Government. 
‘‘(2) APPLICATION OF PROVISIONS.—The Insti-
tute shall be subject to the provisions of this section, 
and, to the extent consistent with this section, to the 
District of Columbia Nonprofit Corporation Act. 
‘‘(3) FUNDING
OF
COMPARATIVE
EFFECTIVE-
NESS RESEARCH.—For fiscal year 2009 and each 
subsequent fiscal year, amounts in the Comparative 
Effectiveness Research Trust Fund (referred to in 
this section as the ‘CERTF’) under section 9511 of 
the Internal Revenue Code of 1986 shall be avail-
able, without further appropriation, to the Institute 
to carry out this section. 
‘‘(c) PURPOSE.—The purpose of the Institute is to 
improve health care delivered to individuals in the United 
States by advancing the quality and thoroughness of evi-
dence concerning the manner in which diseases, disorders, 
and other health conditions can effectively and appro-
priately be prevented, diagnosed, treated, and managed 
clinically through research and evidence synthesis, and the 
dissemination of research findings with respect to the rel-
ative outcomes, effectiveness, and appropriateness of the 
medical treatments, services, and items described in sub-
section (a)(2)(B). 
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‘‘(d) DUTIES.— 
‘‘(1) IDENTIFYING RESEARCH PRIORITIES AND 
ESTABLISHING RESEARCH PROJECT AGENDA.— 
‘‘(A) 
IDENTIFYING
RESEARCH
PRIOR-
ITIES.—The Institute shall identify national 
priorities for comparative clinical effectiveness 
research, taking into account factors, includ-
ing— 
‘‘(i) disease incidence, prevalence, and 
burden in the United States; 
‘‘(ii) evidence gaps in terms of clinical 
outcomes; 
‘‘(iii) practice variations, including 
variations in delivery and outcomes by ge-
ography, treatment site, provider type, and 
patient subgroup; 
‘‘(iv) the potential for new evidence 
concerning certain categories of health care 
services or treatments to improve patient 
health and well-being, and the quality of 
care; and 
‘‘(v) the effect or potential for an ef-
fect on health expenditures associated with 
a health condition or the use of a par-
ticular medical treatment, service, or item. 
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‘‘(B) ESTABLISHING
RESEARCH
PROJECT 
AGENDA.— 
‘‘(i) IN GENERAL.—The Institute shall 
establish and update a research project 
agenda to address the priorities identified 
under subparagraph (A), taking into con-
sideration the types of research that might 
address each priority and the relative value 
(determined based on the cost of con-
ducting such research compared to the po-
tential usefulness of the information pro-
duced by such research) associated with 
such different types of research, and such 
other factors as the Institute determines 
appropriate. 
‘‘(ii) CONSIDERATION
OF
NEED
TO 
CONDUCT A SYSTEMATIC REVIEW.—In es-
tablishing and updating the research 
project agenda under clause (i), the Insti-
tute shall consider the need to conduct a 
systematic review of existing research (in-
cluding research on comparative effective-
ness conducted with funds provided under 
division A of Public Law 111–5) before 
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providing for the conduct of new research 
under paragraph (2)(A). 
‘‘(2) CARRYING OUT RESEARCH PROJECT AGEN-
DA.— 
‘‘(A) COMPARATIVE CLINICAL EFFECTIVE-
NESS RESEARCH.—In carrying out the research 
project agenda established under paragraph 
(1)(B), the Institute shall provide for the con-
duct of appropriate research and the synthesis 
of evidence, in accordance with the methodo-
logical standards adopted under paragraph (9), 
using methods, including the following: 
‘‘(i) Systematic reviews and assess-
ments of existing research and evidence. 
‘‘(ii) Clinical research, such as ran-
domized controlled trials and observational 
studies. 
‘‘(iii) Any other methodologies rec-
ommended by the methodology committee 
established under paragraph (6) that are 
adopted by the Board under paragraph 
(9). 
‘‘(B)(i) CONTRACTS WITH FEDERAL AGEN-
CIES AND INSTRUMENTALITIES.—The Institute 
may enter into contracts with agencies and in-
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strumentalities of the Federal Government that 
have experience in conducting comparative clin-
ical effectiveness research, such as the Agency 
for Healthcare Research and Quality, for the 
management and conduct of research in accord-
ance with the research project agenda estab-
lished under paragraph (1)(B), to the extent 
that such contracts are authorized under the 
governing statutes of such agencies and instru-
mentalities. 
‘‘(ii) CONTRACTS
WITH
OTHER
ENTI-
TIES.—The Institute may enter into contracts 
with appropriate private sector research or 
study-conducting entities for the conduct of re-
search described in clause (i). 
‘‘(iii) 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 that 
apply to the Institute with respect to the 
research managed or conducted under such 
contract; 
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‘‘(II) comply with the methodological 
standards adopted under paragraph (9) 
with respect to such research; and 
‘‘(III) take into consideration public 
comments on the study design that are 
transmitted by the Institute to the agency, 
instrumentality, or other entity under sub-
section (i)(1) during the finalization of the 
study design and transmit responses to 
such comments to the Institute, which will 
publish such comments, responses, and fi-
nalized study design in accordance with 
paragraph (7)(C) prior to the conduct of 
such research. 
‘‘(iv) COVERAGE OF COPAYMENTS OR COIN-
SURANCE.—A contract entered into under this 
subparagraph may allow for the coverage of co-
payments or co-insurance, or allow for other ap-
propriate measures, to the extent that such cov-
erage or other measures are necessary to pre-
serve the validity of a research project, such as 
in the case where the research project must be 
blinded. 
‘‘(C) REVIEW
AND
UPDATE
OF
EVI-
DENCE.—The Institute shall review and update 
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evidence on a periodic basis, in order to take 
into account new research and evolving evidence 
as they become available, as appropriate. 
‘‘(D) TAKING INTO ACCOUNT POTENTIAL 
DIFFERENCES.—Research shall— 
‘‘(i) be designed, as appropriate, to 
take into account the potential for dif-
ferences in the effectiveness of health care 
treatments, services, and items as used 
with various subpopulations, such as racial 
and ethnic minorities, women, different age 
groups, and individuals with different 
comorbidities; and 
‘‘(ii) seek to include members of such 
subpopulations as subjects in the research 
as feasible and appropriate. 
‘‘(3) DATA COLLECTION.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
with appropriate 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 the Institute may require to carry 
out this section. The Institute may also request 
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and, if such request is granted, obtain data 
from Federal, State, or private entities. 
‘‘(B) USE OF DATA.—The Institute shall 
only use data provided to the Institute under 
subparagraph (A) in accordance with laws and 
regulations governing the release and use of 
such data, including applicable confidentiality 
and privacy standards. 
‘‘(4) APPOINTING ADVISORY PANELS.— 
‘‘(A) IN GENERAL.—The Institute may ap-
point permanent or ad hoc advisory panels as 
determined appropriate by the Institute to as-
sist in the establishment and carrying out of 
the research project agenda under paragraphs 
(1) and (2), respectively. Panels may advise or 
guide the Institute in matters such as identi-
fying gaps in and updating medical evidence 
and identifying research priorities and potential 
study designs in order to ensure that the infor-
mation produced from such research is clinically 
relevant to decisions made by clinicians and pa-
tients at the point of care and may provide ad-
vice throughout the conduct of research. 
‘‘(B) COMPOSITION.—An advisory panel 
appointed under subparagraph (A) shall include 
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representatives of clinicians and patients and 
may include experts in scientific and health 
services research, health services delivery, and 
the manufacture of health items who have expe-
rience in the relevant topic, project, or category 
for which the panel is established. 
‘‘(5) 
ESTABLISHING
METHODOLOGY
COM-
MITTEE.— 
‘‘(A) IN GENERAL.—The Institute shall es-
tablish a standing methodology committee to 
carry out the functions described in subpara-
graph (C). 
‘‘(B) APPOINTMENT AND COMPOSITION.— 
Members shall be appointed to the methodology 
committee established under subparagraph (A) 
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 effectiveness research, 
biostatistics, 
and 
research 
methodologies. 
Stakeholders with such expertise may be ap-
pointed to the methodology committee. 
‘‘(C) FUNCTIONS.—Subject to subpara-
graph (D), the methodology committee shall 
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work to develop and improve the science of 
comparative effectiveness research by under-
taking the following activities: 
‘‘(i) Not later than 1 year after the 
date on which the members of the method-
ology committee are appointed under sub-
paragraph (B), developing and periodically 
updating methodological standards regard-
ing outcomes measures, risk adjustment, 
statistical protocols, evaluation of evidence, 
conduct of research, and other aspects of 
research and assessment to be used when 
conducting research on comparative clinical 
effectiveness (and procedures for the use of 
such standards) in order to help ensure ac-
curate and effective comparisons. Such 
standards shall also include methods by 
which new information, data, or advances 
in technology are considered and incor-
porated into ongoing research projects by 
the Institute, as appropriate. In developing 
and updating methodological standards 
under this clause, the methodology com-
mittee shall ensure that such standards are 
scientifically based. 
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‘‘(ii) Not later than 2 years after such 
date, examining the following: 
‘‘(I) Methods by which various 
aspects of the health care delivery sys-
tem (such as benefit design and per-
formance, and health services organi-
zation, management, and delivery) 
could be assessed and compared for 
their relative effectiveness, benefits, 
risks, advantages, and disadvantages 
in a scientifically valid and standard-
ized way. 
‘‘(II) Methods by which cost-ef-
fectiveness and value could be as-
sessed in a scientifically valid and 
standardized way. 
‘‘(D) CONSULTATION
AND
CONDUCT
OF 
EXAMINATIONS.— 
‘‘(i) IN GENERAL.—Subject to clause 
(iii), in undertaking the activities described 
in subparagraph (C), the methodology 
committee shall— 
‘‘(I) consult or contract with 1 or 
more of the entities described in 
clause (ii); and 
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‘‘(II) consult with stakeholders 
and other entities knowledgeable in 
relevant fields, as appropriate. 
‘‘(ii) ENTITIES DESCRIBED.—The fol-
lowing entities are described in this clause: 
‘‘(I) The Institute of Medicine of 
the National Academies. 
‘‘(II) The Agency for Healthcare 
Research and Quality. 
‘‘(III) The National Institutes of 
Health. 
‘‘(iii) CONDUCT OF EXAMINATIONS.— 
The methodology committee shall contract 
with the Institute of Medicine of the Na-
tional Academies for the conduct of the ex-
aminations described in subclauses (I) and 
(II) of subparagraph (C)(ii). 
‘‘(E) REPORTS.—The methodology com-
mittee shall submit reports to the Board on the 
committee’s performance of the functions de-
scribed in subparagraph (C). Reports submitted 
under the preceding sentence with respect to 
the functions described in clause (i) of such 
subparagraph shall contain recommendations— 
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‘‘(i) for the Institute to adopt meth-
odological standards developed and up-
dated by the methodology committee under 
such subparagraph; and 
‘‘(ii) for such other action as the 
methodology committee determines is nec-
essary to comply with such methodological 
standards. 
‘‘(6) PROVIDING
FOR
A
PEER-REVIEW
PROC-
ESS.— 
‘‘(A) IN GENERAL.—The Institute shall en-
sure that there is a process for peer review of 
the research conducted under this section. 
Under such process— 
‘‘(i) evidence from research conducted 
under this section shall be reviewed to as-
sess scientific integrity and adherence to 
methodological standards adopted under 
paragraph (8); and 
‘‘(ii) a list of the names of individuals 
contributing to any peer-review process 
during the preceding year or years shall be 
made public and included in annual reports 
in accordance with paragraph (10)(D). 
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‘‘(B) 
COMPOSITION.—Such 
peer-review 
process shall have been designed in a manner so 
as to avoid bias and conflicts of interest on the 
part of the reviewers and shall be composed of 
experts in the scientific field relevant to the re-
search under review. 
‘‘(C) USE
OF
EXISTING
PROCESSES.—In 
the case where the Institute enters into a con-
tract 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). 
‘‘(7) DISSEMINATION
OF
RESEARCH
FIND-
INGS.— 
‘‘(A) IN
GENERAL.—The Institute shall 
disseminate research findings to clinicians, pa-
tients, and the general public in accordance 
with the dissemination protocols and strategies 
adopted under paragraph (8). Research findings 
disseminated— 
‘‘(i) shall convey findings of research 
so that they are comprehensible and useful 
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to patients and providers in making health 
care decisions; 
‘‘(ii) shall discuss findings and other 
considerations specific to certain sub-
populations, 
risk 
factors, 
and 
comorbidities, as appropriate; 
‘‘(iii) shall include considerations such 
as limitations of research and what further 
research may be needed, as appropriate; 
‘‘(iv) shall not include practice guide-
lines or policy recommendations; and 
‘‘(v) shall not include any data the 
dissemination of which would violate the 
privacy of research participants or violate 
any confidentiality agreements made with 
respect to the use of data under this sec-
tion. 
‘‘(B) DISSEMINATION
PROTOCOLS
AND 
STRATEGIES.—The Institute shall develop pro-
tocols and strategies for the appropriate dis-
semination of research findings in order to en-
sure effective communication of such findings 
and the use and incorporation of such findings 
into relevant activities for the purpose of in-
forming higher quality and more effective and 
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efficient decisions regarding medical treat-
ments, services, and items. In developing and 
adopting such protocols and strategies, the In-
stitute shall consult with stakeholders con-
cerning the types of dissemination that will be 
most useful to the end users of the information 
and may provide for the utilization of multiple 
formats for conveying findings to different audi-
ences. 
‘‘(C) PUBLIC
AVAILABILITY.—The Insti-
tute shall make available to the public and dis-
close through the official public Internet website 
of the Institute, and through other forums and 
media the Institute determines appropriate, the 
following: 
‘‘(i) The process and methods for the 
conduct of research under this section, in-
cluding— 
‘‘(I) the identity of the entity 
conducting such research; 
‘‘(II) any links the entity has to 
industry (including such links that are 
not directly tied to the particular re-
search being conducted under this sec-
tion); 
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‘‘(III) draft study designs (in-
cluding research questions and the fi-
nalized study design, together with 
public comments on such study design 
and responses to such comments); 
‘‘(IV) research protocols (includ-
ing measures taken, methods of re-
search, methods of analysis, research 
results, and such other information as 
the Institute determines appropriate); 
‘‘(V) the identity of investigators 
conducting such research and any 
conflicts of interest of such investiga-
tors; and 
‘‘(VI) any progress reports the 
Institute determines appropriate. 
‘‘(ii) Public comments submitted dur-
ing each of the public comment periods 
under subsection (i)(1). 
‘‘(iii) Bylaws, processes, and pro-
ceedings of the Institute, to the extent 
practicable and as the Institute determines 
appropriate. 
‘‘(iv) Not later than 90 days after re-
ceipt by the Institute of a relevant report 
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or research findings, appropriate informa-
tion contained in such report or findings. 
‘‘(v) All reports, findings, results, and 
studies conducted by or through the Insti-
tute. 
The Institute shall obtain and incorporate pub-
lic feedback through media (such as an Internet 
website) on the information disclosed. 
‘‘(D) FUNDING.—At least 5 percent of the 
funds made available each fiscal year under the 
CERTF shall be expended on activities under 
this paragraph. 
‘‘(E) DEFINITION
OF
RESEARCH
FIND-
INGS.—In this paragraph, the term ‘research 
findings’ means the results of a study, ap-
praisal, or assessment. 
‘‘(8) ADOPTION.—Subject to subsection (i)(1), 
the Institute shall adopt the national priorities iden-
tified 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 
(5)(C)(i), any peer-review process provided under 
paragraph (6), and dissemination protocols and 
strategies developed under paragraph (7)(B) by ma-
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jority vote. In the case where the Institute does not 
adopt such national priorities, research project agen-
da, methodological standards, peer-review process, or 
dissemination protocols and strategies in accordance 
with the preceding sentence, the national priorities, 
research project agenda, methodological standards, 
peer-review process, or dissemination protocols and 
strategies shall be referred to the appropriate staff 
or entity within the Institute (or, in the case of the 
methodological standards, the methodology com-
mittee) for further review. 
‘‘(9) COORDINATION
OF
RESEARCH
AND
RE-
SOURCES
AND
BUILDING
CAPACITY
FOR
RE-
SEARCH.— 
‘‘(A) COORDINATION
OF
RESEARCH
AND 
RESOURCES.—The Institute shall coordinate re-
search conducted, commissioned, or otherwise 
funded under this section with comparative clin-
ical effectiveness and other relevant research 
and related efforts conducted by public and pri-
vate agencies and organizations in order to en-
sure the most efficient use of the Institute’s re-
sources and that research is not duplicated un-
necessarily. 
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‘‘(B) INCLUSION IN ANNUAL REPORTS.— 
The Institute shall report on any coordination 
and capacity building conducted under this 
paragraph in annual reports in accordance with 
paragraph (10)(E). 
‘‘(10) ANNUAL REPORTS.—The Institute shall 
submit an annual report to Congress and the Presi-
dent, and shall make the annual report available to 
the public. Such report shall contain— 
‘‘(A) a description of the activities con-
ducted under this section during the preceding 
year, including the use of amounts appropriated 
or credited to the CERTF under section 
9511(b) of the Internal Revenue Code of 1986 
to carry out this section, research projects com-
pleted and underway, and a summary of the 
findings of such projects; 
‘‘(B) the research project agenda and 
budget of the Institute for the following year; 
‘‘(C) a description of research priorities 
identified under paragraph (1)(A), dissemina-
tion protocols and strategies developed by the 
Institute under paragraph (7)(B), and meth-
odological standards developed and updated by 
the methodology committee under paragraph 
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(5)(C)(i) that are adopted under paragraph (8) 
during the preceding year; 
‘‘(D) the names of individuals contributing 
to any peer-review process provided under para-
graph (6) during the preceding year or years, in 
a manner such that those individuals cannot be 
identified with a particular research project; 
‘‘(E) a description of efforts by the Insti-
tute under paragraph (9) to— 
‘‘(i) coordinate the research con-
ducted, commissioned, or otherwise funded 
under this section and the resources of the 
Institute with research and related efforts 
conducted by other private and public enti-
ties; and 
‘‘(ii) build capacity for comparative 
clinical effectiveness research and other 
relevant 
research 
and 
related 
efforts 
through appropriate activities; and 
‘‘(F) any other relevant information (in-
cluding information on the membership of the 
Board, advisory panels appointed under para-
graph (4), the methodology committee estab-
lished under paragraph (6), and the executive 
staff of the Institute, any conflicts of interest 
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with respect to the members of such Board, ad-
visory panels, and methodology committee, or 
with respect to any individuals selected for em-
ployment as executive staff of the Institute, and 
any bylaws adopted by the Board during the 
preceding year). 
‘‘(11) CONFLICTS OF INTEREST.—The Institute 
shall— 
‘‘(A) in appointing members to an advisory 
panel under subsection (d)(4) and the method-
ology committee under subsection (d)(5), and in 
selecting individuals to contribute to any peer- 
review process under subsection (d)(6) and for 
employment as executive staff of the Institute, 
take into consideration any conflicts of interest 
of potential appointees, participants, and staff; 
and 
‘‘(B) include a description of any such con-
flicts of interest and conflicts of interest of 
Board members in the annual report under sub-
section (d)(10), except that, in the case of indi-
viduals 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. 
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‘‘(e) ADMINISTRATION.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Board shall carry out the duties of the Institute. 
‘‘(2) NONDELEGABLE DUTIES.—The activities 
described in subsections (b)(3)(D), (d)(1), and 
(d)(8) are nondelegable. 
‘‘(f) BOARD OF GOVERNORS.— 
‘‘(1) IN GENERAL.—The Institute shall have a 
Board of Governors, which shall consist of the fol-
lowing members: 
‘‘(A) The Secretary of Health and Human 
Services (or the Secretary’s designee). 
‘‘(B) The Director of the Agency for 
Healthcare Research and Quality (or the Direc-
tor’s designee). 
‘‘(C) The Director of the National Insti-
tutes of Health (or the Director’s designee). 
‘‘(D) 18 members appointed by the Comp-
troller General of the United States not later 
than 6 months after the date of enactment of 
this section, as follows: 
‘‘(i) 3 members representing patients 
and health care consumers. 
‘‘(ii) 3 members representing prac-
ticing physicians, including surgeons. 
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‘‘(iii) 3 members representing agen-
cies that administer public programs, as 
follows: 
‘‘(I) 1 member representing the 
Centers for Medicare & Medicaid 
Services who has experience in admin-
istering the program under title 
XVIII. 
‘‘(II) 1 member representing 
agencies that administer State health 
programs (who may represent the 
Centers for Medicare & Medicaid 
Services and have experience in ad-
ministering the program under title 
XIX or the program under title XXI 
or be a governor of a State). 
‘‘(III) 1 member representing 
agencies that administer other Fed-
eral health programs (such as a 
health program of the Department of 
Defense under chapter 55 of title 10, 
United States Code, the Federal em-
ployees health benefits program under 
chapter 89 of title 5 of such Code, a 
health program of the Department of 
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Veterans Affairs under chapter 17 of 
title 38 of such Code, or a medical 
care program of the Indian Health 
Service or of a tribal organization). 
‘‘(iv) 3 members representing private 
payers, of whom at least 1 member shall 
represent health insurance issuers and at 
least 1 member shall represent employers 
who self-insure employee benefits. 
‘‘(v) 3 members representing pharma-
ceutical, device, and technology manufac-
turers or developers. 
‘‘(vi) 1 member representing nonprofit 
organizations involved in health services re-
search. 
‘‘(vii) 1 member representing organi-
zations that focus on quality measurement 
and improvement or decision support. 
‘‘(viii) 1 member representing inde-
pendent health services researchers. 
‘‘(2) QUALIFICATIONS.— 
‘‘(A) DIVERSE REPRESENTATION OF PER-
SPECTIVES.—The Board shall represent a broad 
range of perspectives and collectively have sci-
entific expertise in clinical practice and clinical 
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health sciences research, including epidemi-
ology, decisions sciences, health economics, and 
statistics. 
‘‘(B) CONFLICTS OF INTEREST.— 
‘‘(i) IN
GENERAL.—In appointing 
members of the Board under paragraph 
(1)(D), the Comptroller General of the 
United States shall take into consideration 
any conflicts of interest of potential ap-
pointees. Any conflicts of interest of mem-
bers appointed to the Board under para-
graph (1) shall be disclosed in accordance 
with subsection (d)(7). 
‘‘(ii) RECUSAL.—A member of the 
Board shall be recused from participating 
with respect to a particular research 
project or other matter considered by the 
Board in carrying out its research project 
agenda under subsection (d)(2) in the case 
where the member (or an immediate family 
member of such member) has a financial 
or personal interest directly related to the 
research project or the matter that could 
affect or be affected by such participation. 
‘‘(3) TERMS.— 
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‘‘(A) IN
GENERAL.—A member of the 
Board appointed under paragraph (1)(D) shall 
be appointed for a term of 6 years, except with 
respect to the members first appointed under 
such paragraph— 
‘‘(i) 6 shall be appointed for a term of 
6 years; 
‘‘(ii) 6 shall be appointed for a term 
of 4 years; and 
‘‘(iii) 6 shall be appointed for a term 
of 2 years. 
‘‘(B) LIMITATION.—No individual shall be 
appointed to the Board under paragraph (1)(D) 
for more than 2 terms. 
‘‘(C) EXPIRATION OF TERM.—Any member 
of the Board whose term has expired may serve 
until such member’s successor has taken office, 
or until the end of the calendar year in which 
such member’s term has expired, whichever is 
earlier. 
‘‘(D) VACANCIES.— 
‘‘(i) IN GENERAL.—Any member ap-
pointed to fill a vacancy prior to the expi-
ration of the term for which such mem-
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ber’s predecessor was appointed shall be 
appointed for the remainder of such term. 
‘‘(ii) VACANCIES
NOT
TO
AFFECT 
POWER
OF
BOARD.—A vacancy on the 
Board shall not affect its powers, but shall 
be filled in the same manner as the origi-
nal appointment was made. 
‘‘(4) CHAIRPERSON AND VICE-CHAIRPERSON.— 
‘‘(A) IN
GENERAL.—From among the 
members of the Board appointed under para-
graph (1)(D), the Comptroller General of the 
United States shall designate a member who is 
a physician with national research credentials 
as Chairperson of the Board and another mem-
ber as Vice-Chairperson of the Board. 
‘‘(B) TERM.—The members so designated 
shall serve as Chairperson and Vice-Chair-
person of the Board for a period of 3 years. 
‘‘(5) COMPENSATION.— 
‘‘(A) IN
GENERAL.—A member of the 
Board shall be entitled to compensation at the 
per diem equivalent of the rate provided for 
level IV of the Executive Schedule under section 
5315 of title 5, United States Code. 
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‘‘(B) TRAVEL
EXPENSES.—While away 
from home or regular place of business in the 
performance of duties for the Board, each mem-
ber of the Board may receive reasonable travel, 
subsistence, and other necessary expenses. 
‘‘(6) DIRECTOR
AND
STAFF; EXPERTS
AND 
CONSULTANTS.—The Board may— 
‘‘(A) employ and fix the compensation of 
an executive director and such other personnel 
as may be necessary to carry out the duties of 
the Institute; 
‘‘(B) seek such assistance and support as 
may be required in the performance of the du-
ties of the Institute from appropriate depart-
ments and agencies of the Federal Government; 
‘‘(C) enter into contracts or make other ar-
rangements and make such payments as may 
be necessary for performance of the duties of 
the Institute; 
‘‘(D) provide travel, subsistence, and per 
diem compensation for individuals performing 
the duties of the Institute, including members 
of any advisory panel appointed under sub-
section (d)(4), members of the methodology 
committee established under subsection (d)(5), 
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and individuals selected to contribute to any 
peer-review process under subsection (d)(6); 
and 
‘‘(E) prescribe such rules, regulations, and 
bylaws as the Board determines necessary with 
respect to the internal organization and oper-
ation 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. In the 
case where the Board is meeting on matters not re-
lated to personnel, Board meetings shall be open to 
the public and advertised. 
‘‘(8) QUORUM.—A majority of the members of 
the Board shall constitute a quorum for purposes of 
conducting the duties of the Institute, but a lesser 
number of members may meet and hold hearings. 
‘‘(g) FINANCIAL 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 OF AUDIT AND REPORT TO CON-
GRESS.—The Comptroller General of the United 
States shall— 
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‘‘(A) review the results of the audits con-
ducted under paragraph (1); and 
‘‘(B) submit a report to Congress con-
taining the results of such audits and review. 
‘‘(h) GOVERNMENTAL OVERSIGHT.— 
‘‘(1) REVIEW AND REPORTS.— 
‘‘(A) IN GENERAL.—The Comptroller Gen-
eral of the United States shall review the fol-
lowing: 
‘‘(i) Processes established by the In-
stitute, including those with respect to the 
identification of research priorities under 
subsection (d)(1)(A) and the conduct of re-
search projects under this section. Such re-
view shall determine whether information 
produced by such research projects— 
‘‘(I) is objective and credible; 
‘‘(II) is produced in a manner 
consistent 
with 
the 
requirements 
under this section; and 
‘‘(III) is developed through a 
transparent process. 
‘‘(ii) The overall effect of the Institute 
and the effectiveness of activities con-
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ducted under this section, including an as-
sessment of— 
‘‘(I) the utilization of the find-
ings of research conducted under this 
section by health care decision mak-
ers; and 
‘‘(II) the effect of the Institute 
and such activities on innovation and 
on the health economy of the United 
States. 
‘‘(B) REPORTS.—Not later than 5 years 
after the date of enactment of this section, and 
not less frequently than every 5 years there-
after, the Comptroller General of the United 
States shall submit a report to Congress con-
taining the results of the review conducted 
under subparagraph (A), together with rec-
ommendations for such legislation and adminis-
trative action as the Comptroller General deter-
mines appropriate. 
‘‘(2) FUNDING ASSESSMENT.— 
‘‘(A) IN GENERAL.—The Comptroller Gen-
eral of the United States shall assess the ade-
quacy and use of funding for the Institute and 
activities conducted under this section under 
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the CERTF under section 9511 of the Internal 
Revenue Code of 1986. Such assessment shall 
include a determination as to whether, based on 
the utilization of findings by public and private 
payers, each of the following are appropriate 
sources of funding for the Institute, including a 
determination of whether such sources of fund-
ing should be continued or adjusted: 
‘‘(i) The amounts appropriated under 
subparagraphs (A), (B), (C), (D)(ii), and 
(E)(ii) of subsection (b)(1) of such section 
9511. 
‘‘(ii) 
Private 
sector 
contributions 
under subparagraphs (D)(i) and (E)(i) of 
such subsection (b)(1). 
‘‘(B) REPORT.—Not later than 8 years 
after the date of enactment of this section, the 
Comptroller General of the United States shall 
submit a report to Congress containing the re-
sults of the assessment conducted under sub-
paragraph (A), together with recommendations 
for such legislation and administrative action as 
the Comptroller General determines appro-
priate. 
‘‘(i) PUBLIC COMMENT PERIODS.— 
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‘‘(1) IN GENERAL.—The Institute shall provide 
for a public comment period of not less than 30 and 
not more than 60 days at the following times: 
‘‘(A) Prior to the adoption of the national 
priorities identified under subsection (d)(1)(A), 
the research project agenda established under 
subsection (d)(1)(B), the methodological stand-
ards developed and updated by the methodology 
committee under subsection (d)(5)(C)(i), the 
peer-review process generally provided under 
subsection (d)(6), and dissemination protocols 
and strategies developed by the Institute under 
subsection (d)(7)(B) in accordance with sub-
section (d)(8). 
‘‘(B) Prior to the finalization of individual 
study designs. 
‘‘(2) TRANSMISSION OF PUBLIC COMMENTS ON 
STUDY DESIGN.—The Institute shall transmit public 
comments submitted during the public comment pe-
riod described in paragraph (1)(B) to the entity con-
ducting research with respect to which the individual 
study design is being finalized. 
‘‘(j) RULES.— 
‘‘(1) GIFTS.—The Institute, or the Board and 
staff of the Institute acting on behalf of the Insti-
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tute, may not accept gifts, bequeaths, or donations 
of services or property. 
‘‘(2) ESTABLISHMENT
AND
PROHIBITION
ON 
ACCEPTING
OUTSIDE
FUNDING
OR
CONTRIBU-
TIONS.—The Institute may not— 
‘‘(A) establish a corporation other than as 
provided under this section; or 
‘‘(B) accept any funds or contributions 
other than as provided under this part. 
‘‘(k) RULES OF CONSTRUCTION.— 
‘‘(1) COVERAGE.—Nothing in this section shall 
be construed— 
‘‘(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 cov-
ering the routine costs of clinical care received 
by an individual entitled to, or enrolled for, ben-
efits under title XVIII, XIX, or XXI in the case 
where such individual is participating in a clin-
ical trial and such costs would otherwise be cov-
ered under such title with respect to the bene-
ficiary. 
‘‘(2) REPORTS AND FINDINGS.—None of the re-
ports submitted under this section or research find-
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ings disseminated by the Institute shall be construed 
as mandates, guidelines, or recommendations for 
payment, coverage, or treatment. 
‘‘(3) PHYSICIAN
OUT.—None of the reports 
submitted under this section or research findings 
disseminated by the Institute shall be construed to 
prevent the physician and patient to ultimately de-
termine what is best for the patient involved given 
the individual circumstances of different patients.’’. 
(b) COORDINATION WITH PROVIDER EDUCATION 
AND TECHNICAL ASSISTANCE.—Section 1889(a) of the 
Social Security Act (42 U.S.C. 1395zz(a)) is amended by 
inserting ‘‘and to enhance the understanding of and utili-
zation by providers of services and suppliers of research 
findings disseminated by the Health Care Comparative Ef-
fectiveness Research Institute established under section 
1181’’ before the period at the end. 
(c) 
COMPARATIVE
EFFECTIVENESS
RESEARCH 
TRUST FUND; FINANCING FOR TRUST FUND.— 
(1) ESTABLISHMENT OF TRUST FUND.— 
(A) IN GENERAL.—Subchapter A of chap-
ter 98 of the Internal Revenue Code of 1986 
(relating to establishment of trust funds) is 
amended by adding at the end the following 
new section: 
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‘‘SEC. 9511. COMPARATIVE EFFECTIVENESS RESEARCH 
TRUST FUND. 
‘‘(a) CREATION OF TRUST FUND.—There is estab-
lished in the Treasury of the United States a trust fund 
to be known as the ‘Comparative Effectiveness Research 
Trust Fund’ (hereafter in this section referred to as the 
‘CERTF’), consisting of such amounts as may be appro-
priated or credited to such Trust Fund as provided in this 
section and section 9602(b). 
‘‘(b) TRANSFERS TO FUND.— 
‘‘(1) FROM ARRA FUNDING FOR CER.—There 
are hereby transferred to the CERTF the amounts 
appropriated to carry out comparative effectiveness 
research under division A of Public Law 111–5. 
whether appropriated for the National Institutes of 
Health, the Secretary of Health and Human Serv-
ices, or the Agency for Healthcare Research and 
Quality, which are not otherwise obligated or ex-
pended as of the date of the enactment of this sec-
tion. 
‘‘(2) FROM MEDICARE TRUST FUNDS.— 
‘‘(A) IN
GENERAL.—The Secretary of 
Health and Human Services shall provide for 
the transfer, from the Federal Hospital Insur-
ance Trust Fund under section 1817 of the So-
cial Security Act and the Federal Supple-
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mentary Medical Insurance Trust Fund under 
section 1841 of such Act, in proportion (as esti-
mated by the Secretary) to the total expendi-
tures during such fiscal year that are made 
under title XVIII of such title from the respec-
tive trust fund, to the CERTF the following: 
‘‘(i) For fiscal year 2010, an amount 
equal to 50 cents multiplied by the average 
number of individuals entitled to benefits 
under part A, or enrolled under part B, of 
title XVIII of such Act during such fiscal 
year. 
‘‘(ii) For each of fiscal years 2011 
through 2020, an amount equal to $1 mul-
tiplied by the average number of individ-
uals entitled to benefits under part A, or 
enrolled under part B, of such 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, 2011, 
the dollar amount in effect under subparagraph 
(A)(ii) for such fiscal year shall be equal to the 
sum of such dollar amount for the previous fis-
cal year (determined after the application of 
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this subparagraph), plus an amount equal to 
the product of— 
‘‘(i) such dollar amount for the pre-
vious fiscal year; multiplied by 
‘‘(ii) the percentage increase in the 
projected per capita amount of National 
Health Expenditures from the calendar 
year in which the previous fiscal year ends 
to the calendar year in which the fiscal 
year involved ends, as most recently pub-
lished by the Secretary before the begin-
ning of the fiscal year. 
‘‘(3) ADDITIONAL
TRANSFERS
FOR
FISCAL 
YEARS 2010 THROUGH 2020.—There are hereby ap-
propriated to the CERTF for each of fiscal years 
2010 through 2020, an amount equivalent to the net 
revenues received in the Treasury from the fees im-
posed under subchapter B of chapter 34 (relating to 
fees on health insurance and self-insured plans) for 
such fiscal year. 
‘‘(4) LIMITATION ON TRANSFERS TO CERTF.— 
No amount may be appropriated or transferred to 
the CERTF on and after the date of any expendi-
ture from the CERTF which is not an expenditure 
permitted under this section. The determination of 
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whether an expenditure is so permitted shall be 
made without regard to— 
‘‘(A) any provision of law which is not con-
tained or referenced in this chapter or in a rev-
enue Act, and 
‘‘(B) whether such provision of law is a 
subsequently enacted provision or directly or in-
directly seeks to waive the application of this 
paragraph. 
‘‘(c) TRUSTEE.—The Secretary of Health and 
Human Services shall be a trustee of the CERTF. 
‘‘(d) EXPENDITURES FROM FUND.—Amounts in the 
CERTF are available, without further appropriation, to 
the Health Care Comparative Effectiveness Research In-
stitute established by section 2(a) of the Comparative Ef-
fectiveness Research Act of 2009 for carrying out part D 
of title XI of the Social Security Act (as in effect on the 
date of enactment of the Comparative Effectiveness Re-
search Act of 2009). 
‘‘(e) NET REVENUES.—For purposes of this section, 
the term ‘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 
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‘‘(2) the decrease in the tax imposed by chapter 
1 resulting from the fees imposed by such sub-
chapter. 
‘‘(f) TERMINATION.—No amounts shall be available 
for expenditure from the CERTF after September 30, 
2020, and any amounts in such Trust Fund after such 
date shall be transferred to the general fund of the Treas-
ury.’’. 
(B) CLERICAL AMENDMENT.—The table of 
sections for subchapter A of chapter 98 of such 
Code is amended by adding at the end the fol-
lowing new item: 
‘‘Sec. 9511. Comparative Effectiveness Research Trust Fund.’’. 
(2) FINANCING FOR FUND FROM FEES ON IN-
SURED AND SELF-INSURED HEALTH PLANS.— 
(A) GENERAL RULE.—Chapter 34 of the 
Internal Revenue 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. 
‘‘(a) IMPOSITION OF FEE.—There is hereby imposed 
on each specified health insurance policy for each policy 
year ending after September 30, 2009, a fee equal to the 
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product of $1 (50 cents in the case of policy years ending 
during fiscal year 2010) multiplied by the average number 
of lives covered under the policy. 
‘‘(b) LIABILITY FOR FEE.—The fee imposed by sub-
section (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 pro-
vided in this section, the term ‘specified health in-
surance policy’ means any accident or health insur-
ance 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 in-
clude any insurance if substantially all of its cov-
erage is of excepted benefits described in section 
9832(c). 
‘‘(3) TREATMENT OF PREPAID HEALTH COV-
ERAGE ARRANGEMENTS.— 
‘‘(A) IN GENERAL.—In the case of any ar-
rangement described in subparagraph (B)— 
‘‘(i) such arrangement shall be treated 
as a specified health insurance policy, and 
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‘‘(ii) the person referred to in such 
subparagraph shall be treated as the 
issuer. 
‘‘(B) DESCRIPTION OF ARRANGEMENTS.— 
An arrangement is described in this subpara-
graph if under such arrangement fixed pay-
ments or premiums are received as consider-
ation for any person’s agreement to provide or 
arrange for the provision of accident or health 
coverage to residents of the United States, re-
gardless of how such coverage is provided or ar-
ranged 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, 2013, the 
dollar amount in effect under subsection (a) for such pol-
icy year shall be equal to the sum of such dollar amount 
for policy years ending in the previous fiscal year (deter-
mined after the application of this subsection), 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 
from the calendar year in which the previous fiscal 
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year ends to the calendar year in which the fiscal 
year involved ends, as most recently published by the 
Secretary of Health and Human Services before the 
beginning of the fiscal year. 
‘‘(e) TERMINATION.—This section shall not apply to 
policy years ending after September 30, 2020. 
‘‘SEC. 4376. SELF-INSURED HEALTH PLANS. 
‘‘(a) IMPOSITION OF FEE.—In the case of any appli-
cable self-insured health plan for each plan year ending 
after September 30, 2011, there is hereby imposed a fee 
equal to $1 (50 cents in the case of plan years ending 
during fiscal year 2012) multiplied by the average number 
of lives covered under the plan. 
‘‘(b) LIABILITY FOR FEE.— 
‘‘(1) IN GENERAL.—The fee imposed by sub-
section (a) shall be paid by the plan sponsor. 
‘‘(2) PLAN SPONSOR.—For purposes of para-
graph (1) the term ‘plan sponsor’ means— 
‘‘(A) the employer in the case of a plan es-
tablished or maintained by a single employer, 
‘‘(B) the employee organization in the case 
of a plan established or maintained by an em-
ployee organization, 
‘‘(C) in the case of— 
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‘‘(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 ar-
rangement, or 
‘‘(iii) a voluntary employees’ bene-
ficiary association described in section 
501(c)(9), 
the association, committee, joint board of trust-
ees, or other similar group of representatives of 
the parties who establish or maintain the plan, 
or 
‘‘(D) the cooperative or association de-
scribed in subsection (c)(2)(F) in the case of a 
plan established or maintained by such a coop-
erative or association. 
‘‘(c) APPLICABLE SELF-INSURED HEALTH PLAN.— 
For purposes of this section, the term ‘applicable self-in-
sured 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— 
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‘‘(A) by one or more employers for the 
benefit of their employees or former employees, 
‘‘(B) by one or more employee organiza-
tions 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 sec-
tion 501(c)(6), or 
‘‘(F) in the case of a plan not described in 
the preceding subparagraphs, by a multiple em-
ployer welfare arrangement (as defined in sec-
tion 3(40) of Employee Retirement Income Se-
curity 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, 2011, the 
dollar amount in effect under subsection (a) for such plan 
year shall be equal to the sum of such dollar amount for 
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