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 provi-
sions 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 2019’’ and as the ‘‘DISARM Act of 2019’’. 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS
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)(I) Effective for discharges beginning on or 
after October 1, 2020, or such sooner date as specified 
by the Secretary, subject to subclause (II), the Secretary 
shall, after notice and opportunity for public comment (in 
the publications required by subsection (e)(5) for a fiscal 
year or otherwise), provide for an additional payment 
under a mechanism (separate from the mechanism estab-
lished under subparagraph (K)), with respect to such dis-
charges involving any DISARM antimicrobial drug, in an 
amount equal to— 
‘‘(aa) the amount payable under section 1847A 
for such drug during the calendar quarter in which 
the discharge occurred; or 
‘‘(bb) if no amount for such drug is determined 
under section 1847A, an amount to be determined 
by the Secretary in a manner similar to the manner 
in which payment amounts are determined under 
section 1847A based on information submitted by 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(iii) The mechanism established pursuant to clause 
(i) shall provide that the additional payment under clause 
(i) shall— 
‘‘(I) with respect to a discharge, only be made 
to a subsection (d) hospital that, as determined by 
the Secretary— 
‘‘(aa) is participating in the National 
Healthcare Safety Network Antimicrobial Use 
and Resistance Module of the Centers for Dis-
ease Control and Prevention; and 
‘‘(bb) has an antimicrobial stewardship 
program that aligns with the Core Elements of 
Hospital Antibiotic Stewardship Programs of 
the Centers for Disease Control and Prevention 
or the Antimicrobial Stewardship Standard set 
by the Joint Commission; and 
‘‘(II) apply to discharges occurring on or after 
October 1 of the year in which the drug or biological 
product is designated by the Secretary as a DIS-
ARM antimicrobial drug. 
For purposes of this clause, in the case of a similar report-
ing program described in item (aa), a subsection (d) hos-
pital shall be treated as participating in such a program 
if the entity maintaining such program identifies to the 
Secretary such hospital as so participating. 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(iv)(I) The mechanism established pursuant to 
clause (i) shall provide for a process for— 
‘‘(aa) a manufacturer or sponsor of a drug or 
biological product to request the Secretary to des-
ignate the drug or biological product as a DISARM 
antimicrobial drug; and 
‘‘(bb) the designation (and removal of such des-
ignation) by the Secretary of drugs and biological 
products as DISARM antimicrobial drugs. 
‘‘(II) A designation of a drug or biological product 
as a DISARM antimicrobial drug may be revoked by the 
Secretary if the Secretary determines that— 
‘‘(aa) the drug or biological product no longer 
meets the requirements for a DISARM antimicrobial 
drug under clause (ii); 
‘‘(bb) the request for such designation con-
tained an untrue statement of material fact; or 
‘‘(cc) clinical or other information that was not 
available to the Secretary at the time such designa-
tion was made shows that— 
‘‘(AA) such drug or biological product is 
unsafe for use or not shown to be safe for use 
for individuals who are entitled to benefits 
under part A; or 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(BB) an alternative to such drug or bio-
logical product is an advance that substantially 
improves the diagnosis or treatment of such in-
dividuals. 
‘‘(III) Not later than October 1, 2020, the Secretary 
shall publish in the Federal Register a list of the DISARM 
antimicrobial drugs designated under this subparagraph 
pursuant to the process established under subclause 
(I)(bb). The Secretary shall annually update such list. 
‘‘(v)(I) For purposes of determining additional pay-
ment amounts under clause (i), a manufacturer or sponsor 
of a drug or biological product that submits a request de-
scribed in clause (iv)(I)(aa) shall submit to the Secretary 
information described in section 1927(b)(3)(A)(iii). 
‘‘(II) The penalties for failure to provide timely infor-
mation under clause (i) of subparagraph (C) section 
1927(b)(3) and for providing false information under 
clause (ii) of such subparagraph shall apply to manufac-
turers and sponsors of a drug or biological product under 
this section with respect to information under subclause 
(I) in the same manner as such penalties apply to manu-
facturers under such clauses with respect to information 
under subparagraph (A) of such section. 
‘‘(vi)(I) The mechanism established pursuant to 
clause (i) shall provide that— 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS
‘‘(aa) except as provided in item (bb), no addi-
tional payment shall be made under this subpara-
graph for discharges involving a DISARM anti-
microbial drug if any additional payments have been 
made for discharges involving such drug as a new 
medical service or technology under subparagraph 
(K); 
‘‘(bb) additional payments may be made under 
this subparagraph for discharges involving a DIS-
ARM antimicrobial drug if any additional payments 
have been made for discharges occurring prior to the 
date of enactment of this subparagraph involving 
such drug as a new medical service or technology 
under subparagraph (K); and 
‘‘(cc) no additional payment shall be made 
under subparagraph (K) for discharges involving a 
DISARM antimicrobial drug as a new medical serv-
ice or technology if any additional payments for dis-
charges involving such drug have been made under 
this subparagraph.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1886(d)(5)(K)(ii)(III) of the Social Security Act (42 
U.S.C. 1395ww(d)(5)(K)(ii)(III)) is amended by 
striking ‘‘provide’’ and inserting ‘‘subject to sub-
paragraph (M)(vii), provide’’. 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS
(b) STUDY AND REPORTS ON REMOVING BARRIERS 
TO
THE DEVELOPMENT
OF DISARM ANTIMICROBIAL 
DRUGS.— 
(1) STUDY.—The Comptroller General of the 
United States (in this subsection referred to as the 
‘‘Comptroller General’’) shall, in consultation with 
the Director of the National Institutes of Health, 
the Commissioner of Food and Drugs, the Adminis-
trator of the Centers for Medicare & Medicaid Serv-
ices, and the Director of the Centers for Disease 
Control and Prevention, conduct 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)(ii) 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) REPORTS.— 
(A) INTERIM REPORT.—Not later than 3 
years after the date of the enactment of this 
Act, the Comptroller General shall submit to 
Congress an interim report containing the pre-
liminary results of the study conducted under 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS
paragraph (1), together with recommendations 
for such legislation and administrative action as 
the Comptroller General determines appro-
priate. 
(B) FINAL
REPORT.—Not later than 5 
years after the date of the enactment of this 
Act, the Comptroller General shall submit to 
Congress a report containing the results of the 
study conducted under paragraph (1), together 
with recommendations for such legislation and 
administrative action as the Comptroller Gen-
eral determines appropriate. 
Æ 
VerDate Sep 11 2014 
00:14 Aug 15, 2019
Jkt 089200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6301
E:\BILLS\H4100.IH
H4100
pamtmann on DSKBFK8HB2PROD with BILLS