I 
111TH CONGRESS 
1ST SESSION H. R. 2824 
To enhance the conduct and support of federally funded comparative 
effectiveness research relating to health care, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 11, 2009 
Mrs. CHRISTENSEN (for herself, Mr. HERGER, and Mr. BOUSTANY) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce, and in addition to the Committees on Ways and Means, 
Armed Services, and Veterans’ Affairs, for a period to be subsequently 
determined by the Speaker, in each case for consideration of such provi-
sions as fall within the jurisdiction of the committee concerned 
A BILL 
To enhance the conduct and support of federally funded 
comparative effectiveness research relating to health care, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Doctor-Patient Rela-
tionship and Research Protection Act’’. 
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SEC. 2. FEDERAL COORDINATING COUNCIL FOR COMPARA-
TIVE EFFECTIVENESS RESEARCH. 
(a) AUTHORITY.—Paragraph (1) of section 804(c) of 
title VIII of division A of the American Recovery and Re-
investment Act of 2009 (42 U.S.C. 299b–8(c)) is amended 
to read as follows: 
‘‘(1) notwithstanding the provisions under the 
heading ‘AGENCY FOR HEALTHCARE RESEARCH AND 
QUALITY’ of this title and any other provision of law, 
have full authority to direct and coordinate all Fed-
eral funding of comparative effectiveness health care 
research, including such research conducted or sup-
ported by the Departments of Health and Human 
Services, Veterans Affairs, and Defense; and’’. 
(b) MEMBERSHIP.—Subsection (d) of section 804 of 
title VIII of division A of the American Recovery and Re-
investment Act of 2009 (42 U.S.C. 299b–8) is amended 
to read as follows: 
‘‘(d) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The members of the Coun-
cil shall include one senior officer or employee from 
each of the following agencies: 
‘‘(A) The Agency for Healthcare Research 
and Quality. 
‘‘(B) The Secretary of Health and Human 
Services. 
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‘‘(C) The Director of the National Insti-
tutes of Health. 
‘‘(D) 20 members, 9 of whom are not full- 
time government employees, appointed by the 
Comptroller General of the United States as 
follows: 
‘‘(i) 3 members representing patients 
and health care consumers. 
‘‘(ii) 3 members representing prac-
ticing physicians, including surgeons. 
‘‘(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 of the Social Security Act. 
‘‘(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 
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of the Social Security Act or be a gov-
ernor 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 Federal employees health 
benefits program under chapter 89 of 
title 5 of the United States Code, a 
health program of the Department of 
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. 
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‘‘(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. 
‘‘(ix) 1 member representing research 
in differences in treatment outcomes along 
the lines of racial and ethnic background, 
gender, and geography. 
‘‘(x) 1 member representing research 
in treating rural populations. 
‘‘(E) QUALIFICATIONS.—At least half of 
the members of the Council shall be physicians 
or other experts with clinical expertise. 
‘‘(2) CHAIRMAN; VICE
CHAIRMAN.—The Sec-
retary shall serve as Chairman of the Council and 
shall designate a member to serve as Vice Chair-
man.’’. 
(c) RULES OF CONSTRUCTION.—Subsection (g) of 
section 804 of title VIII of division A of the American 
Recovery and Reinvestment Act of 2009 (42 U.S.C. 299b– 
8) is amended to read as follows: 
‘‘(g) RULES OF CONSTRUCTION.— 
‘‘(1) COVERAGE.—Nothing in this section shall 
be construed— 
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‘‘(A) to permit the Council to mandate or 
recommend coverage, reimbursement, or other 
policies for any public or private payer; or 
‘‘(B) as preventing the Secretary of Health 
and Human Services from covering the routine 
costs of clinical care received by an individual 
entitled to, or enrolled for, benefits under title 
XVIII, XIX, or XXI of the Social Security Act 
in the case where such individual is partici-
pating in a clinical trial and such costs would 
otherwise be covered under such title with re-
spect to the beneficiary. 
‘‘(2) REPORTS AND FINDING.—No report sub-
mitted under this section or research findings dis-
seminated by the Council shall be construed as man-
dates, guidelines, or recommendations for payment, 
coverage, or treatment.’’. 
(d) TRANSPARENCY, CREDIBILITY, AND ACCESS.— 
Section 804 of title VIII of division A of the American 
Recovery and Reinvestment Act of 2009 (42 U.S.C. 299b– 
8) is amended by adding at the end the following: 
‘‘(h) TRANSPARENCY, CREDIBILITY, AND ACCESS.— 
The Council shall establish procedures to ensure that the 
following requirements for ensuring transparency, credi-
bility, and access are met: 
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‘‘(1) PUBLIC COMMENT PERIOD.— 
‘‘(A) COMMENT PRIOR TO OBLIGATION OF 
FUNDS
FOR
RESEARCH.—Before any Federal 
funds may be obligated to conduct or support 
comparative effectiveness research, the Council 
shall provide for a period of not less than 30 
days for the public to comment on the research 
proposal. 
‘‘(B) COMMENT
AFTER
RESEARCH
RE-
SULTS
PUBLISHED.—After the publication of 
the results of research described in subpara-
graph (A), the Council shall provide for a pe-
riod of 60 days for the public to comment on 
such results. 
‘‘(C) TRANSMISSION
OF
PUBLIC
COM-
MENTS.—The Council shall ensure the trans-
mission of public comments submitted under 
subparagraph (A) to the entity conducting the 
research with respect to which the individual 
study design is being finalized. 
‘‘(2) ADDITIONAL FORUMS.—The Council shall, 
in addition to the public comment period described 
in paragraph (1), support forums to increase public 
awareness and obtain and incorporate public feed-
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back through media (such as an Internet website) on 
the following: 
‘‘(A) The identification of comparative ef-
fectiveness research priorities. 
‘‘(B) Comparative effectiveness research 
findings. 
‘‘(C) Any other duties, activities, or proc-
esses the Council determines appropriate. 
‘‘(3) PUBLIC AVAILABILITY.—The Council shall 
make available to the public and disclose through 
the official public Internet website of the Council, 
and through other forums and media the Council de-
termines appropriate, the following: 
‘‘(A) The process and methods for the con-
duct of comparative effectiveness research pur-
suant to this section, including— 
‘‘(i) the identity of the entity con-
ducting any such research; 
‘‘(ii) any links the entity has to indus-
try (including such links that are not di-
rectly tied to the particular research); 
‘‘(iii) draft study designs (including 
research questions and the finalized study 
design, together with public comments on 
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such study design and responses to such 
comments); 
‘‘(iv) research protocols (including 
measures taken, methods of research, 
methods of analysis, research results, and 
such other information as the Council de-
termines appropriate); 
‘‘(v) the identity of investigators con-
ducting such research and any conflicts of 
interest of such investigators; and 
‘‘(vi) any progress reports the Council 
determines appropriate. 
‘‘(B) Public comments submitted during 
each public comment period under paragraph 
(1)(A). 
‘‘(C) Bylaws, processes, and proceedings of 
the Council, to the extent practicable and as the 
Council determines appropriate. 
‘‘(D) Not later than 60 days after receipt 
by the Council of a relevant report or compara-
tive effectiveness research finding, appropriate 
information contained in such report or finding. 
‘‘(4) CONFLICTS OF INTEREST.— 
‘‘(A) IN GENERAL.—The Council shall— 
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‘‘(i) in appointing members to an ad-
visory panel, and in selecting individuals to 
contribute to any peer-review process and 
for employment as executive staff of the 
Council, take into consideration any con-
flicts of interest of potential appointees, 
participants, and staff; and 
‘‘(ii) include a description of any such 
conflicts of interest and conflicts of inter-
est of Council members in an annual re-
port to the Congress, except that, in the 
case of individuals contributing to any 
such peer review process, such description 
shall be in a manner such that those indi-
viduals cannot be identified with a par-
ticular research project. 
‘‘(B) DEFINITION.—In this subsection, the 
term ‘conflict of interest’ means associations, 
including financial and personal, that may be 
reasonably assumed to have the potential to 
bias an individual’s decisions in matters related 
to the Council or the conduct of the compara-
tive effectiveness research.’’. 
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SEC. 3. APPLICATION OF FEDERALLY FUNDED CLINICAL 
COMPARATIVE EFFECTIVENESS RESEARCH. 
(a) LIMITATION ON CMS.—The Administrator of the 
Centers for Medicare & Medicaid Services may not use 
federally funded clinical comparative effectiveness re-
search data to make coverage determinations under title 
XVIII of the Social Security Act for medical treatments, 
services, and items on the basis of cost. 
(b) REQUIREMENT FOR IMPLEMENTATION.—Feder-
ally funded clinical comparative effectiveness research and 
related evaluation and communication activities shall re-
flect the principle that clinicians and patients should have 
the best available evidence upon which to make choices 
in health care items and services, in providers, and in 
health care delivery systems, recognizing that patient sub-
populations and patient and physician preferences may 
vary. 
(c) APPEALS OF CERTAIN MEDICARE COVERAGE DE-
TERMINATIONS.—In the case of a national or local cov-
erage determination under title XVIII of the Social Secu-
rity Act that has been made utilizing federally funded 
comparative effectiveness research, an individual entitled 
to benefits under such title shall— 
(1) be an eligible requester under section 
1869(h)(1)(B) of such Act in relation; 
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(2) have expedited access (as specified by the 
Secretary) to coverage determinations, redetermina-
tions, and appeals relating to such determinations; 
and 
(3) have full access to all administrative or judi-
cial review under section 1869 of such Act with re-
spect to such determinations. 
(d) RULE OF CONSTRUCTION.—Nothing in this Act 
or the amendments made by this Act shall be construed 
to require coverage of any drug, biological product, device, 
or treatment that has been determined by the Food and 
Drug Administration to be unsafe. 
(e) DISAGGREGATION OF RESEARCH RESULTS.—No 
Federal funds may be made available to any person for 
any federally funded clinical comparative effectiveness re-
search, unless the person agrees to ensure that, whenever 
possible, the methodology and research protocols will in-
clude variables that not only measure, but can be 
disaggregated to analyze and identify, any differences 
along the lines of racial and ethnic background, gender, 
and geography that may exist among and within patient 
subpopulations. 
(f) DEFINITIONS.—In this section: 
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(1) The term ‘‘federally funded clinical com-
parative effectiveness research’’ means research 
that— 
(A) evaluates and compares the clinical ef-
fectiveness, risks, and benefits of 2 or more 
medical treatments, services, and items; and 
(B) is conducted or supported in accord-
ance with provisions of title VIII of division A 
of the American Recovery and Reinvestment 
Act of 2009 or with the use of other Federal 
funds. 
(2) The term ‘‘medical treatments, services, and 
items’’ means health care interventions, protocols for 
treatment, procedures, medical devices, diagnostic 
tools, 
pharmaceuticals 
(including 
drugs 
and 
biologicals), and any other processes or items being 
used in the treatment and diagnosis of, or preven-
tion of illness or injury in, patients. 
(3) The term ‘‘patient subpopulations’’ means 
populations of patients of different racial and ethnic 
backgrounds, genders, and geographic locations. 
Æ 
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