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 consideration 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Developing an Innova5 tive Strategy for Antimicrobial Resistant Microorganisms 

6 Act of 2014’’ and as the ‘‘DISARM Act of 2014’’. 


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1 SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF 

2 NEW ANTIMICROBIAL DRUGS. 

3 (a) ADDITIONAL PAYMENT FOR NEW ANTI4 MICROBIAL DRUGS UNDER MEDICARE.— 

5 (1) IN GENERAL.—Section 1886(d)(5) of the 

6 Social Security Act (42 U.S.C. 1395ww(d)(5)) is 

7 amended by adding at the end the following new 

8 subparagraph: 

9 ‘‘(M)(i) Effective for discharges beginning on or after 

10 October 1, 2014, the Secretary shall, after notice and op11 portunity for public comment (in the publications required 

12 by subsection (e)(5) for a fiscal year or otherwise), recog13 nize the costs of new antimicrobial drugs under the pay14 ment system established under this subsection. 

15 ‘‘(ii) Pursuant to clause (i), the Secretary shall pro16 vide for additional payment to be made under this sub17 section with respect to discharges involving new anti18 microbial drugs in the amount provided for under section 

19 1847A for drugs and biologicals that are described in sec20 tion 1842(o)(1)(C). 

21 ‘‘(iii) For purposes of this subparagraph, the term 

22 ‘new antimicrobial drug’ means a product that is approved 

23 for use, or a product for which an indication is first ap24 proved for use, by the Federal Food and Drug Administra25 tion on or after January 1, 2014, and that— 


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1 ‘‘(I) is indicated to treat an infection caused by, 

2 or likely to be caused by, a qualifying pathogen (as 

3 defined under section 505E(f) of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355f(f))) for 

5 which there is an unmet medical need and which is 

6 associated with high rates of mortality or significant 

7 patient morbidity (as determined by the Secretary, 

8 in consultation with the Director of the Centers for 

9 Disease Control and Prevention and the infectious 

10 disease professional community); and 

11 ‘‘(II) is used in facilities that participate in the 

12 Antimicrobial Use and Resistance Module of the Na13 tional Healthcare Safety Network of the Centers for 

14 Disease Control and Prevention (or, in the case that 

15 such Module is not available, is used in facilities that 

16 participate in such successor or similar reporting 

17 module or program relating to antimicrobials as the 

18 Secretary shall specify to the extent available to 

19 such facilities, as determined by the Secretary). 

20 ‘‘(iv) Not later than July 1, 2014, the Secretary shall 

21 first publish in the Federal Register a list of the new anti22 microbial drugs.’’. 

23 (2) BUDGET NEUTRALITY.—Section 

24 1886(d)(3)(C) of the Social Security Act (42 U.S.C. 


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1 1395ww(d)(3)(C)) is amended by adding at the end 

2 the following new clause: 

3 ‘‘(iii) MAINTAINING BUDGET NEUTRALITY FOR

4 CERTAIN ANTIMICROBIAL DRUGS.—For discharges 

5 occurring in a fiscal year beginning with fiscal year 

6 2015, the Secretary shall further reduce each of the 

7 average standardized amounts in an amount equal 

8 to the amount of the net additional expenditures, if 

9 any, in such fiscal year resulting from the applica10 tion of paragraph (5)(M).’’. 

11 (b) STUDY AND REPORT ON REMOVING BARRIERS TO

12 DEVELOPMENT OF NEW ANTIMICROBIAL DRUGS.— 

13 (1) STUDY.—The Comptroller General of the 

14 United States shall, in consultation with the Direc15 tor of the United States Patent and Trademark Of16 fice, the Director of the National Institutes of 

17 Health, the Commissioner of Food and Drugs, and 

18 the Director of the Centers for Disease Control and 

19 Prevention, conduct a study to— 

20 (A) identify and examine the barriers that 

21 prevent the development of new antimicrobial 

22 drugs, as defined in section 1886(d)(5)(M)(iii) 

23 of the Social Security Act (42 U.S.C. 

24 1395ww(d)(5)(M)(iii)); and 


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1 (B) develop recommendations for actions 

2 to be taken in order to overcome any barriers 

3 identified under subparagraph (A). 

4 (2) REPORT.—Not later than one year after the 

5 date of the enactment of this Act, the Comptroller 

6 General shall submit to Congress a report on the 

7 study conducted under paragraph (1). 

Æ 


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