II 

116TH CONGRESS 

1ST SESSION S. 1712 

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 SENATE OF THE UNITED STATES 

JUNE 4, 2019 

Mr. ISAKSON (for himself and Mr. CASEY) introduced the following bill; which 

was read twice and referred to the Committee on Finance 

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’’. 

7 SEC. 2. ENCOURAGING THE DEVELOPMENT AND USE OF 

8 DISARM ANTIMICROBIAL DRUGS. 

9 (a) ADDITIONAL PAYMENT FOR DISARM ANTI10 MICROBIAL DRUGS UNDER MEDICARE.— 


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

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

3 amended by adding at the end the following new 

4 subparagraph: 

5 ‘‘(M)(i)(I) Effective for discharges beginning on or 

6 after October 1, 2020, subject to subclause (II), the Sec7 retary shall, after notice and opportunity for public com8 ment (in the publications required by subsection (e)(5) for 

9 a fiscal year or otherwise), provide for an additional pay10 ment under a mechanism (separate from the mechanism 

11 established under subparagraph (K)), with respect to such 

12 discharges involving any DISARM antimicrobial drug, in 

13 an amount equal to— 

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

15 for such drug during the calendar quarter in which 

16 the discharge occurred; or 

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

18 under section 1847A, an amount to be determined 

19 by the Secretary in a manner similar to the manner 

20 in which payment amounts are determined under 

21 section 1847A based on information submitted by 

22 the manufacturer or sponsor of such drug (as re23 quired under clause (v)). 

24 ‘‘(II) In determining the amount payable under sec25 tion 1847A for purposes of items (aa) and (bb) of subVerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712

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1 clause (I), subparagraphs (A) and (B) of subsection (b)(1) 

2 of such section shall be applied by substituting ‘102 per3 cent’ for ‘106 percent’ each place it appears and para4 graph (8)(B) of such section shall be applied by sub5 stituting ‘2 percent’ for ‘6 percent’. 

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

7 antimicrobial drug is— 

8 ‘‘(I) a drug— 

9 ‘‘(aa) that— 

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

11 Drug Administration; 

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

13 Drug Administration as a qualified infec14 tious disease product under subsection (d) 

15 of section 505E of the Federal Food, 

16 Drug, and Cosmetic Act; and 

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

18 exclusivity period pursuant to subsection 

19 (a) of such section; and 

20 ‘‘(bb) that has been designated by the Sec21 retary pursuant to the process established 

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

23 ‘‘(II) an antibacterial or antifungal biological 

24 product— 


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1 ‘‘(aa) that is licensed for use, or an anti2 bacterial or antifungal biological product for 

3 which an indication is first licensed for use, by 

4 the Food and Drug Administration on or after 

5 June 5, 2014, under section 351(a) of the Pub6 lic Health Service Act for human use to treat 

7 serious or life-threatening infections, as deter8 mined by the Food and Drug Administration, 

9 including those caused by, or likely to be caused 

10 by— 

11 ‘‘(AA) an antibacterial or antifungal 

12 resistant pathogen, including novel or 

13 emerging infectious pathogens; or 

14 ‘‘(BB) a qualifying pathogen (as de15 fined under section 505E(f) of the Federal 

16 Food, Drug, and Cosmetic Act); and 

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

18 pursuant to the process established under 

19 clause (iv)(I)(bb). 

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

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

22 (i) shall— 

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

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

25 the Secretary— 


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1 ‘‘(aa) is participating in the National 

2 Healthcare Safety Network Antimicrobial Use 

3 and Resistance Module of the Centers for Dis4 ease Control and Prevention or a similar report5 ing program, as specified by the Secretary, re6 lating to antimicrobial drugs; and 

7 ‘‘(bb) has an antimicrobial stewardship 

8 program that aligns with the Core Elements of 

9 Hospital Antibiotic Stewardship Programs of 

10 the Centers for Disease Control and Prevention 

11 or the Antimicrobial Stewardship Standard set 

12 by the Joint Commission; and 

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

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

15 product is designated by the Secretary as a DIS16 ARM antimicrobial drug. 

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

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

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

20 biological product to request the Secretary to des21 ignate the drug or biological product as a DISARM 

22 antimicrobial drug; and 

23 ‘‘(bb) the designation by the Secretary of drugs 

24 and biological products as DISARM antimicrobial 

25 drugs. 


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

2 as a DISARM antimicrobial drug may be revoked by the 

3 Secretary if the Secretary determines that— 

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

5 meets the requirements for a DISARM antimicrobial 

6 drug under clause (ii); 

7 ‘‘(bb) the request for such designation con8 tained an untrue statement of material fact; or 

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

10 available to the Secretary at the time such designa11 tion was made shows that— 

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

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

14 for individuals who are entitled to benefits 

15 under part A; or 

16 ‘‘(BB) an alternative to such drug or bio17 logical product is an advance that substantially 

18 improves the diagnosis or treatment of such in19 dividuals. 

20 ‘‘(III) Not later than October 1, 2020, and annually 

21 thereafter, the Secretary shall publish in the Federal Reg22 ister a list of the DISARM antimicrobial drugs designated 

23 under this subparagraph pursuant to the process estab24 lished under clause (iv)(I)(bb). 


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1 ‘‘(v)(I) For purposes of determining additional pay2 ment amounts under clause (i), a manufacturer or sponsor 

3 of a drug or biological product that submits a request de4 scribed in clause (iv)(I)(aa) shall submit to the Secretary 

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

6 ‘‘(II) The penalties for failure to provide timely infor7 mation under clause (i) of subparagraph (C) under section 

8 1927(b)(3) and for providing false information under 

9 clause (ii) of such subparagraph shall apply to manufac10 turers and sponsors of a drug or biological product under 

11 this section with respect to information under subclause 

12 (I) in the same manner as such penalties apply to manu13 facturers under such clauses with respect to information 

14 under subparagraph (A) of such section. 

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

16 clause (i) shall provide that— 

17 ‘‘(aa) except as provided in item (bb), no addi18 tional payment shall be made under this subpara19 graph for discharges involving a DISARM anti20 microbial drug if any additional payments have been 

21 made for discharges involving such drug as a new 

22 medical service or technology under subparagraph 

23 (K); 

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

25 this subparagraph for discharges involving a DISVerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712

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1 ARM antimicrobial drug if any additional payments 

2 have been made for discharges occurring prior to the 

3 date of enactment of this subparagraph involving 

4 such drug as a new medical service or technology 

5 under subparagraph (K); and 

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

7 under subparagraph (K) for discharges involving a 

8 DISARM antimicrobial drug as a new medical serv9 ice or technology if any additional payments for dis10 charges involving such drug have been made under 

11 this subparagraph.’’. 

12 (2) CONFORMING AMENDMENT.—Section 

13 1886(d)(5)(K)(ii)(III) of the Social Security Act (42 

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

15 striking ‘‘provide’’ and inserting ‘‘subject to sub16 paragraph (M)(vii), provide’’. 

17 (b) STUDY AND REPORTS ON REMOVING BARRIERS

18 TO THE DEVELOPMENT OF DISARM ANTIMICROBIAL

19 DRUGS.— 

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

21 United States (in this subsection referred to as the 

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

23 the Director of the National Institutes of Health, 

24 the Commissioner of Food and Drugs, the Adminis25 trator of the Centers for Medicare & Medicaid ServVerDate Sep 11 2014 04:54 Jun 08, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1712.IS S1712

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1 ices, and the Director of the Centers for Disease 

2 Control and Prevention, conduct a study to— 

3 (A) identify and examine the barriers that 

4 prevent the development of DISARM anti5 microbial drugs (as defined in section 

6 1886(d)(5)(M)(ii) of the Social Security Act, as 

7 added by subsection (a)); and 

8 (B) develop recommendations for actions 

9 to be taken in order to overcome any barriers 

10 identified under subparagraph (A). 

11 (2) REPORTS.— 

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

13 years after the date of the enactment of this 

14 Act, the Comptroller General shall submit to 

15 Congress an interim report containing the pre16 liminary results of the study conducted under 

17 paragraph (1), together with recommendations 

18 for such legislation and administrative action as 

19 the Comptroller General determines appro20 priate. 

21 (B) FINAL REPORT.—Not later than 5 

22 years after the date of the enactment of this 

23 Act, the Comptroller General shall submit to 

24 Congress a report containing the results of the 

25 study conducted under paragraph (1), together 


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1 with recommendations for such legislation and 

2 administrative action as the Comptroller Gen3 eral determines appropriate. 

Æ 


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