I 

116TH CONGRESS 

1ST SESSION H. R. 4100 

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 

JULY 30, 2019 

Mr. DANNY K. DAVIS of Illinois (for himself, Mr. MARCHANT, Ms. SEWELL

of Alabama, Mr. MARSHALL, Mr. HOLDING, Mr. MICHAEL F. DOYLE of 

Pennsylvania, and Mrs. WALORSKI) 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 2019’’ and as the ‘‘DISARM Act of 2019’’. 


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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)(I) Effective for discharges beginning on or 

10 after October 1, 2020, or such sooner date as specified 

11 by the Secretary, subject to subclause (II), the Secretary 

12 shall, after notice and opportunity for public comment (in 

13 the publications required by subsection (e)(5) for a fiscal 

14 year or otherwise), provide for an additional payment 

15 under a mechanism (separate from the mechanism estab16 lished under subparagraph (K)), with respect to such dis17 charges involving any DISARM antimicrobial drug, in an 

18 amount equal to— 

19 ‘‘(aa) the amount payable under section 1847A 

20 for such drug during the calendar quarter in which 

21 the discharge occurred; or 

22 ‘‘(bb) if no amount for such drug is determined 

23 under section 1847A, an amount to be determined 

24 by the Secretary in a manner similar to the manner 

25 in which payment amounts are determined under 

26 section 1847A based on information submitted by 


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1 the manufacturer or sponsor of such drug (as re2 quired under clause (v)). 

3 ‘‘(II) In determining the amount payable under sec4 tion 1847A for purposes of items (aa) and (bb) of sub5 clause (I), subparagraphs (A) and (B) of subsection (b)(1) 

6 of such section shall be applied by substituting ‘102 per7 cent’ for ‘106 percent’ each place it appears and para8 graph (8)(B) of such section shall be applied by sub9 stituting ‘2 percent’ for ‘6 percent’. 

10 ‘‘(ii) For purposes of this subparagraph, a DISARM 

11 antimicrobial drug is— 

12 ‘‘(I) a drug— 

13 ‘‘(aa) that— 

14 ‘‘(AA) is approved by the Food and 

15 Drug Administration; 

16 ‘‘(BB) is designated by the Food and 

17 Drug Administration as a qualified infec18 tious disease product under subsection (d) 

19 of section 505E of the Federal Food, 

20 Drug, and Cosmetic Act; and 

21 ‘‘(CC) has received an extension of its 

22 exclusivity period pursuant to subsection 

23 (a) of such section; and 


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1 ‘‘(bb) that has been designated by the Sec2 retary pursuant to the process established 

3 under clause (iv)(I)(bb); or 

4 ‘‘(II) an antibacterial or antifungal biological 

5 product— 

6 ‘‘(aa) that is licensed for use, or an anti7 bacterial or antifungal biological product for 

8 which an indication is first licensed for use, by 

9 the Food and Drug Administration on or after 

10 June 5, 2014, under section 351(a) of the Pub11 lic Health Service Act for human use to treat 

12 serious or life-threatening infections, as deter13 mined by the Food and Drug Administration, 

14 including those caused by, or likely to be caused 

15 by— 

16 ‘‘(AA) an antibacterial or antifungal 

17 resistant pathogen, including novel or 

18 emerging infectious pathogens; or 

19 ‘‘(BB) a qualifying pathogen (as de20 fined under section 505E(f) of the Federal 

21 Food, Drug, and Cosmetic Act); and 

22 ‘‘(bb) has been designated by the Secretary 

23 pursuant to the process established under 

24 clause (iv)(I)(bb). 


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1 ‘‘(iii) The mechanism established pursuant to clause 

2 (i) shall provide that the additional payment under clause 

3 (i) shall— 

4 ‘‘(I) with respect to a discharge, only be made 

5 to a subsection (d) hospital that, as determined by 

6 the Secretary— 

7 ‘‘(aa) is participating in the National 

8 Healthcare Safety Network Antimicrobial Use 

9 and Resistance Module of the Centers for Dis10 ease Control and Prevention; and 

11 ‘‘(bb) has an antimicrobial stewardship 

12 program that aligns with the Core Elements of 

13 Hospital Antibiotic Stewardship Programs of 

14 the Centers for Disease Control and Prevention 

15 or the Antimicrobial Stewardship Standard set 

16 by the Joint Commission; and 

17 ‘‘(II) apply to discharges occurring on or after 

18 October 1 of the year in which the drug or biological 

19 product is designated by the Secretary as a DIS20 ARM antimicrobial drug. 

21 For purposes of this clause, in the case of a similar report22 ing program described in item (aa), a subsection (d) hos23 pital shall be treated as participating in such a program 

24 if the entity maintaining such program identifies to the 

25 Secretary such hospital as so participating. 


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1 ‘‘(iv)(I) The mechanism established pursuant to 

2 clause (i) shall provide for a process for— 

3 ‘‘(aa) a manufacturer or sponsor of a drug or 

4 biological product to request the Secretary to des5 ignate the drug or biological product as a DISARM 

6 antimicrobial drug; and 

7 ‘‘(bb) the designation (and removal of such des8 ignation) by the Secretary of drugs and biological 

9 products as DISARM antimicrobial drugs. 

10 ‘‘(II) A designation of a drug or biological product 

11 as a DISARM antimicrobial drug may be revoked by the 

12 Secretary if the Secretary determines that— 

13 ‘‘(aa) the drug or biological product no longer 

14 meets the requirements for a DISARM antimicrobial 

15 drug under clause (ii); 

16 ‘‘(bb) the request for such designation con17 tained an untrue statement of material fact; or 

18 ‘‘(cc) clinical or other information that was not 

19 available to the Secretary at the time such designa20 tion was made shows that— 

21 ‘‘(AA) such drug or biological product is 

22 unsafe for use or not shown to be safe for use 

23 for individuals who are entitled to benefits 

24 under part A; or 


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1 ‘‘(BB) an alternative to such drug or bio2 logical product is an advance that substantially 

3 improves the diagnosis or treatment of such in4 dividuals. 

5 ‘‘(III) Not later than October 1, 2020, the Secretary 

6 shall publish in the Federal Register a list of the DISARM 

7 antimicrobial drugs designated under this subparagraph 

8 pursuant to the process established under subclause 

9 (I)(bb). The Secretary shall annually update such list. 

10 ‘‘(v)(I) For purposes of determining additional pay11 ment amounts under clause (i), a manufacturer or sponsor 

12 of a drug or biological product that submits a request de13 scribed in clause (iv)(I)(aa) shall submit to the Secretary 

14 information described in section 1927(b)(3)(A)(iii). 

15 ‘‘(II) The penalties for failure to provide timely infor16 mation under clause (i) of subparagraph (C) section 

17 1927(b)(3) and for providing false information under 

18 clause (ii) of such subparagraph shall apply to manufac19 turers and sponsors of a drug or biological product under 

20 this section with respect to information under subclause 

21 (I) in the same manner as such penalties apply to manu22 facturers under such clauses with respect to information 

23 under subparagraph (A) of such section. 

24 ‘‘(vi)(I) The mechanism established pursuant to 

25 clause (i) shall provide that— 


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1 ‘‘(aa) except as provided in item (bb), no addi2 tional payment shall be made under this subpara3 graph for discharges involving a DISARM anti4 microbial drug if any additional payments have been 

5 made for discharges involving such drug as a new 

6 medical service or technology under subparagraph 

7 (K); 

8 ‘‘(bb) additional payments may be made under 

9 this subparagraph for discharges involving a DIS10 ARM antimicrobial drug if any additional payments 

11 have been made for discharges occurring prior to the 

12 date of enactment of this subparagraph involving 

13 such drug as a new medical service or technology 

14 under subparagraph (K); and 

15 ‘‘(cc) no additional payment shall be made 

16 under subparagraph (K) for discharges involving a 

17 DISARM antimicrobial drug as a new medical serv18 ice or technology if any additional payments for dis19 charges involving such drug have been made under 

20 this subparagraph.’’. 

21 (2) CONFORMING AMENDMENT.—Section 

22 1886(d)(5)(K)(ii)(III) of the Social Security Act (42 

23 U.S.C. 1395ww(d)(5)(K)(ii)(III)) is amended by 

24 striking ‘‘provide’’ and inserting ‘‘subject to sub25 paragraph (M)(vii), provide’’. 


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1 (b) STUDY AND REPORTS ON REMOVING BARRIERS

2 TO THE DEVELOPMENT OF DISARM ANTIMICROBIAL

3 DRUGS.— 

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

5 United States (in this subsection referred to as the 

6 ‘‘Comptroller General’’) shall, in consultation with 

7 the Director of the National Institutes of Health, 

8 the Commissioner of Food and Drugs, the Adminis9 trator of the Centers for Medicare & Medicaid Serv10 ices, and the Director of the Centers for Disease 

11 Control and Prevention, conduct a study to— 

12 (A) identify and examine the barriers that 

13 prevent the development of DISARM anti14 microbial drugs (as defined in section 

15 1886(d)(5)(M)(ii) of the Social Security Act, as 

16 added by subsection (a)); and 

17 (B) develop recommendations for actions 

18 to be taken in order to overcome any barriers 

19 identified under subparagraph (A). 

20 (2) REPORTS.— 

21 (A) INTERIM REPORT.—Not later than 3 

22 years after the date of the enactment of this 

23 Act, the Comptroller General shall submit to 

24 Congress an interim report containing the pre25 liminary results of the study conducted under 


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1 paragraph (1), together with recommendations 

2 for such legislation and administrative action as 

3 the Comptroller General determines appro4 priate. 

5 (B) FINAL REPORT.—Not later than 5 

6 years after the date of the enactment of this 

7 Act, the Comptroller General shall submit to 

8 Congress a report containing the results of the 

9 study conducted under paragraph (1), together 

10 with recommendations for such legislation and 

11 administrative action as the Comptroller Gen12 eral determines appropriate. 

Æ 


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