I 
113TH CONGRESS 
2D SESSION 
H. R. 4187 
To amend title XVIII of the Social Security Act to encourage the development 
and use of new antimicrobial drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 11, 2014 
Mr. ROSKAM (for himself and Mr. DANNY K. DAVIS of Illinois) 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 consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To amend title XVIII of the Social Security Act to encourage 
the development and use of new antimicrobial drugs, 
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 ‘‘Developing an Innova-
tive Strategy for Antimicrobial Resistant Microorganisms 
Act of 2014’’ and as the ‘‘DISARM Act of 2014’’. 
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SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF 
NEW ANTIMICROBIAL DRUGS. 
(a) 
ADDITIONAL
PAYMENT
FOR
NEW
ANTI-
MICROBIAL DRUGS UNDER MEDICARE.— 
(1) IN GENERAL.—Section 1886(d)(5) of the 
Social Security Act (42 U.S.C. 1395ww(d)(5)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(M)(i) Effective for discharges beginning on or after 
October 1, 2014, the Secretary shall, after notice and op-
portunity for public comment (in the publications required 
by subsection (e)(5) for a fiscal year or otherwise), recog-
nize the costs of new antimicrobial drugs under the pay-
ment system established under this subsection. 
‘‘(ii) Pursuant to clause (i), the Secretary shall pro-
vide for additional payment to be made under this sub-
section with respect to discharges involving new anti-
microbial drugs in the amount provided for under section 
1847A for drugs and biologicals that are described in sec-
tion 1842(o)(1)(C). 
‘‘(iii) For purposes of this subparagraph, the term 
‘new antimicrobial drug’ means a product that is approved 
for use, or a product for which an indication is first ap-
proved for use, by the Federal Food and Drug Administra-
tion on or after January 1, 2014, and that— 
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‘‘(I) is indicated to treat an infection caused by, 
or likely to be caused by, a qualifying pathogen (as 
defined under section 505E(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355f(f))) for 
which there is an unmet medical need and which is 
associated with high rates of mortality or significant 
patient morbidity (as determined by the Secretary, 
in consultation with the Director of the Centers for 
Disease Control and Prevention and the infectious 
disease professional community); and 
‘‘(II) is used in facilities that participate in the 
Antimicrobial Use and Resistance Module of the Na-
tional Healthcare Safety Network of the Centers for 
Disease Control and Prevention (or, in the case that 
such Module is not available, is used in facilities that 
participate in such successor or similar reporting 
module or program relating to antimicrobials as the 
Secretary shall specify to the extent available to 
such facilities, as determined by the Secretary). 
‘‘(iv) Not later than July 1, 2014, the Secretary shall 
first publish in the Federal Register a list of the new anti-
microbial drugs.’’. 
(2) 
BUDGET
NEUTRALITY.—Section 
1886(d)(3)(C) of the Social Security Act (42 U.S.C. 
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1395ww(d)(3)(C)) is amended by adding at the end 
the following new clause: 
‘‘(iii) MAINTAINING BUDGET NEUTRALITY FOR 
CERTAIN
ANTIMICROBIAL
DRUGS.—For discharges 
occurring in a fiscal year beginning with fiscal year 
2015, the Secretary shall further reduce each of the 
average standardized amounts in an amount equal 
to the amount of the net additional expenditures, if 
any, in such fiscal year resulting from the applica-
tion of paragraph (5)(M).’’. 
(b) STUDY AND REPORT ON REMOVING BARRIERS TO 
DEVELOPMENT OF NEW ANTIMICROBIAL DRUGS.— 
(1) STUDY.—The Comptroller General of the 
United States shall, in consultation with the Direc-
tor of the United States Patent and Trademark Of-
fice, the Director of the National Institutes of 
Health, the Commissioner of Food and Drugs, and 
the Director of the Centers for Disease Control and 
Prevention, conduct a study to— 
(A) identify and examine the barriers that 
prevent the development of new antimicrobial 
drugs, as defined in section 1886(d)(5)(M)(iii) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395ww(d)(5)(M)(iii)); and 
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(B) develop recommendations for actions 
to be taken in order to overcome any barriers 
identified under subparagraph (A). 
(2) REPORT.—Not later than one year after the 
date of the enactment of this Act, the Comptroller 
General shall submit to Congress a report on the 
study conducted under paragraph (1). 
Æ 
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