H. R. 3590—619 
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 
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 
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-
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 
(1), including deadlines for public comments.
H. R. 3590—620 
‘‘(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 
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. 
‘‘(a) IN GENERAL.—
H. R. 3590—621 
‘‘(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 
resource database that collects and contains government-funded 
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
H. R. 3590—622 
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 
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—