I 
114TH CONGRESS 
1ST SESSION 
H. R. 512 
To amend title XVIII of the Social Security Act to encourage the development 
and use of DISARM antimicrobial drugs, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 22, 2015 
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 DISARM 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 2015’’ and as the ‘‘DISARM Act of 2015’’. 
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SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF 
DISARM ANTIMICROBIAL DRUGS. 
(a) ADDITIONAL PAYMENT
FOR DISARM 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, 2015, the Secretary 
shall, after notice and opportunity for public 
comment (in the publications required by sub-
section (e)(5) for a fiscal year or otherwise), 
recognize the costs of DISARM antimicrobial 
drugs under the payment system established 
under this subparagraph. 
‘‘(ii) Pursuant to clause (i), the Secretary 
shall provide for additional payment to be made 
under this subsection with respect to discharges 
involving DISARM antimicrobial drugs in the 
amount provided for under section 1847A for 
drugs and biological products that are described 
in section 1842(o)(1)(C). 
‘‘(iii) For purposes of this subparagraph, 
the term ‘DISARM antimicrobial drug’ means a 
product that is approved or licensed for use, or 
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a product for which an indication is first ap-
proved or licensed for use, by the Food and 
Drug Administration on or after January 1, 
2015, and— 
‘‘(I)(aa) is intended to treat an infec-
tion 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); or 
‘‘(bb) meets the definition of a quali-
fied infectious disease product under sec-
tion 505E(g) of the Federal Food, Drug, 
and Cosmetic Act; 
‘‘(II) is intended to treat an infection 
for which there is an unmet medical need 
as determined by the Food and Drug Ad-
ministration; 
‘‘(III) is intended to treat an infection 
that is associated with high rates of mor-
tality or significant patient morbidity, as 
determined by the Secretary, in consulta-
tion with the Director of the Centers for 
Disease Control and Prevention and the in-
fectious disease professional community; 
and 
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‘‘(IV) is used in facilities that, to the 
extent available to such facilities, as deter-
mined by the Secretary, participate in— 
‘‘(aa) the National Healthcare 
Safety Network of the Centers for 
Disease Control and Prevention; or 
‘‘(bb) a similar reporting pro-
gram relating to antimicrobial drugs, 
as specified by the Secretary. 
‘‘(iv)(I) The manufacturer or sponsor of a 
drug may request the Secretary to designate a 
drug as a DISARM antimicrobial drug at any 
time before or after the submission of an appli-
cation under section 505(b) of the Federal 
Food, Drug, and Cosmetic Act or section 
351(a) of the Public Health Service Act for 
such drug. Pursuant to the previous sentence, 
the Secretary shall, not later than 60 days after 
the submission of such a request, determine 
whether the drug will be considered a DISARM 
antimicrobial drug in the case that it is ap-
proved or licensed for use, or is first approved 
or licensed for an indication. 
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‘‘(II) Except as provided in subclause (III), 
a designation under this clause shall not be 
withdrawn for any reason. 
‘‘(III) The Secretary may revoke a des-
ignation of a drug as a DISARM antimicrobial 
drug product if the Secretary finds that the re-
quest for such designation contained an untrue 
statement of material fact. 
‘‘(v) Not later than October 1, 2016, the 
Secretary shall first publish in the Federal Reg-
ister a list of the DISARM antimicrobial drugs. 
‘‘(vi) The Secretary shall make a propor-
tional adjustment in the standardized amount 
determined under paragraph (3) to assure that 
the provisions of this subparagraph do not re-
sult in aggregate payments under this sub-
section that are greater or less than those that 
would otherwise be made under such subsection 
for a fiscal year.’’. 
(2) RELATIONSHIP TO NTAP PAYMENTS.—Sec-
tion 1886(d)(5) of the Social Security Act (42 
U.S.C. 1395ww(d)(5)), as amended by paragraph 
(1), is further amended in subparagraph (K)— 
(A) in clause (i), by inserting ‘‘that are not 
DISARM antimicrobial drugs (as defined in 
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subparagraph (M)(iii))’’ after ‘‘new medical 
services and technologies’’; and 
(B) in clause (ii)(I), by inserting ‘‘if the 
service or technology is not a DISARM anti-
microbial drug and’’ after ‘‘a new medical serv-
ice or technology’’. 
(b) STUDY AND REPORT ON REMOVING BARRIERS TO 
DEVELOPMENT OF DISARM ANTIMICROBIAL DRUGS.— 
(1) STUDY.—The Comptroller General of the 
United States shall, in consultation with the Direc-
tor of the National Institutes of Health, the Com-
missioner of Food and Drugs, and the Director of 
the Centers for Disease Control and Prevention, con-
duct a study to— 
(A) identify and examine the barriers that 
prevent the development of DISARM anti-
microbial 
drugs, 
as 
defined 
in 
section 
1886(d)(5)(M)(iii) of the Social Security Act, 
as added by subsection (a); and 
(B) develop recommendations for actions 
to be taken in order to overcome any barriers 
identified under subparagraph (A). 
(2) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Comptroller 
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General shall submit to Congress a report on the 
study conducted under paragraph (1). 
Æ 
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