I 
111TH CONGRESS 
1ST SESSION H. R. 3002 
To protect all patients by prohibiting the use of data obtained from compara-
tive effectiveness research to deny coverage of items or services under 
Federal health care programs and to ensure that comparative effective-
ness research accounts for advancements in personalized medicine and 
differences in patient treatment response. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 23, 2009 
Mr. BOEHNER (for himself and Mr. CANTOR) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on Ways and Means, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To protect all patients by prohibiting the use of data ob-
tained from comparative effectiveness research to deny 
coverage of items or services under Federal health care 
programs and to ensure that comparative effectiveness 
research accounts for advancements in personalized medi-
cine and differences in patient treatment response. 
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 ‘‘Preserving Access to 
Targeted, Individualized, and Effective New Treatments 
and Services (PATIENTS) Act of 2009’’ or the ‘‘PA-
TIENTS Act of 2009’’. 
SEC. 2. PROHIBITION ON CERTAIN USES OF DATA OB-
TAINED FROM COMPARATIVE EFFECTIVE-
NESS RESEARCH; ACCOUNTING FOR PERSON-
ALIZED MEDICINE AND DIFFERENCES IN PA-
TIENT TREATMENT RESPONSE. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, the Secretary of Health and Human Serv-
ices— 
(1) shall not use data obtained from the con-
duct of comparative effectiveness research, including 
such research that is conducted or supported using 
funds appropriated under the American Recovery 
and Reinvestment Act of 2009 (Public Law 111–5), 
to deny coverage of an item or service under a Fed-
eral health care program (as defined in section 
1128B(f) of the Social Security Act (42 U.S.C. 
1320a–7b(f))); and 
(2) shall ensure that comparative effectiveness 
research conducted or supported by the Federal 
Government accounts for factors contributing to dif-
ferences in the treatment response and treatment 
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preferences of patients, including patient-reported 
outcomes, genomics and personalized medicine, the 
unique needs of health disparity populations, and in-
direct patient benefits. 
(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as affecting the authority of the 
Commissioner of Food and Drugs under the Federal 
Food, Drug, and Cosmetic Act or the Public Health Serv-
ice Act. 
Æ 
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