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 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 DISARM 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 2015’’ and as the ‘‘DISARM Act of 2015’’. 


SSpencer on DSK4SPTVN1PROD with BILLS
2 

•HR 512 IH

1 SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF 

2 DISARM ANTIMICROBIAL DRUGS. 

3 (a) ADDITIONAL PAYMENT FOR DISARM 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 

10 on or after October 1, 2015, the Secretary 

11 shall, after notice and opportunity for public 

12 comment (in the publications required by sub13 section (e)(5) for a fiscal year or otherwise), 

14 recognize the costs of DISARM antimicrobial 

15 drugs under the payment system established 

16 under this subparagraph. 

17 ‘‘(ii) Pursuant to clause (i), the Secretary 

18 shall provide for additional payment to be made 

19 under this subsection with respect to discharges 

20 involving DISARM antimicrobial drugs in the 

21 amount provided for under section 1847A for 

22 drugs and biological products that are described 

23 in section 1842(o)(1)(C). 

24 ‘‘(iii) For purposes of this subparagraph, 

25 the term ‘DISARM antimicrobial drug’ means a 

26 product that is approved or licensed for use, or 


SSpencer on DSK4SPTVN1PROD with BILLS
3 

•HR 512 IH

1 a product for which an indication is first ap2 proved or licensed for use, by the Food and 

3 Drug Administration on or after January 1, 

4 2015, and— 

5 ‘‘(I)(aa) is intended to treat an infec6 tion caused by, or likely to be caused by, 

7 a qualifying pathogen (as defined under 

8 section 505E(f) of the Federal Food, 

9 Drug, and Cosmetic Act); or 

10 ‘‘(bb) meets the definition of a quali11 fied infectious disease product under sec12 tion 505E(g) of the Federal Food, Drug, 

13 and Cosmetic Act; 

14 ‘‘(II) is intended to treat an infection 

15 for which there is an unmet medical need 

16 as determined by the Food and Drug Ad17 ministration; 

18 ‘‘(III) is intended to treat an infection 

19 that is associated with high rates of mor20 tality or significant patient morbidity, as 

21 determined by the Secretary, in consulta22 tion with the Director of the Centers for 

23 Disease Control and Prevention and the in24 fectious disease professional community; 

25 and 


SSpencer on DSK4SPTVN1PROD with BILLS
4 

•HR 512 IH

1 ‘‘(IV) is used in facilities that, to the 

2 extent available to such facilities, as deter3 mined by the Secretary, participate in— 

4 ‘‘(aa) the National Healthcare 

5 Safety Network of the Centers for 

6 Disease Control and Prevention; or 

7 ‘‘(bb) a similar reporting pro8 gram relating to antimicrobial drugs, 

9 as specified by the Secretary. 

10 ‘‘(iv)(I) The manufacturer or sponsor of a 

11 drug may request the Secretary to designate a 

12 drug as a DISARM antimicrobial drug at any 

13 time before or after the submission of an appli14 cation under section 505(b) of the Federal 

15 Food, Drug, and Cosmetic Act or section 

16 351(a) of the Public Health Service Act for 

17 such drug. Pursuant to the previous sentence, 

18 the Secretary shall, not later than 60 days after 

19 the submission of such a request, determine 

20 whether the drug will be considered a DISARM 

21 antimicrobial drug in the case that it is ap22 proved or licensed for use, or is first approved 

23 or licensed for an indication. 


SSpencer on DSK4SPTVN1PROD with BILLS
5 

•HR 512 IH

1 ‘‘(II) Except as provided in subclause (III), 

2 a designation under this clause shall not be 

3 withdrawn for any reason. 

4 ‘‘(III) The Secretary may revoke a des5 ignation of a drug as a DISARM antimicrobial 

6 drug product if the Secretary finds that the re7 quest for such designation contained an untrue 

8 statement of material fact. 

9 ‘‘(v) Not later than October 1, 2016, the 

10 Secretary shall first publish in the Federal Reg11 ister a list of the DISARM antimicrobial drugs. 

12 ‘‘(vi) The Secretary shall make a propor13 tional adjustment in the standardized amount 

14 determined under paragraph (3) to assure that 

15 the provisions of this subparagraph do not re16 sult in aggregate payments under this sub17 section that are greater or less than those that 

18 would otherwise be made under such subsection 

19 for a fiscal year.’’. 

20 (2) RELATIONSHIP TO NTAP PAYMENTS.—Sec21 tion 1886(d)(5) of the Social Security Act (42 

22 U.S.C. 1395ww(d)(5)), as amended by paragraph 

23 (1), is further amended in subparagraph (K)— 

24 (A) in clause (i), by inserting ‘‘that are not 

25 DISARM antimicrobial drugs (as defined in 


SSpencer on DSK4SPTVN1PROD with BILLS
6 

•HR 512 IH

1 subparagraph (M)(iii))’’ after ‘‘new medical 

2 services and technologies’’; and 

3 (B) in clause (ii)(I), by inserting ‘‘if the 

4 service or technology is not a DISARM anti5 microbial drug and’’ after ‘‘a new medical serv6 ice or technology’’. 

7 (b) STUDY AND REPORT ON REMOVING BARRIERS TO

8 DEVELOPMENT OF DISARM ANTIMICROBIAL DRUGS.— 

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

10 United States shall, in consultation with the Direc11 tor of the National Institutes of Health, the Com12 missioner of Food and Drugs, and the Director of 

13 the Centers for Disease Control and Prevention, con14 duct a study to— 

15 (A) identify and examine the barriers that 

16 prevent the development of DISARM anti17 microbial drugs, as defined in section 

18 1886(d)(5)(M)(iii) of the Social Security Act, 

19 as added by subsection (a); and 

20 (B) develop recommendations for actions 

21 to be taken in order to overcome any barriers 

22 identified under subparagraph (A). 

23 (2) REPORT.—Not later than 1 year after the 

24 date of the enactment of this Act, the Comptroller 


SSpencer on DSK4SPTVN1PROD with BILLS
7 

•HR 512 IH

1 General shall submit to Congress a report on the 

2 study conducted under paragraph (1). 

Æ 


SSpencer on DSK4SPTVN1PROD with BILLS