I 
117TH CONGRESS 
1ST SESSION H. R. 4127 
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 
JUNE 24, 2021 
Mr. DANNY K. DAVIS of Illinois (for himself 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 com-
mittee 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 2021’’ and as the ‘‘DISARM Act of 2021’’. 
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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: 
‘‘(N)(i)(I) Effective for discharges beginning on or 
after October 1, 2021, 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 
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the manufacturer or sponsor of such drug (as re-
quired under clause (v)). 
‘‘(II) In determining the amount payable under sec-
tion 1847A for purposes of items (aa) and (bb) of sub-
clause (I), subparagraphs (A) and (B) of subsection (b)(1) 
of such section shall be applied by substituting ‘102 per-
cent’ for ‘106 percent’ each place it appears and para-
graph (8)(B) of such section shall be applied by sub-
stituting ‘2 percent’ for ‘6 percent’. 
‘‘(ii) For purposes of this subparagraph, a DISARM 
antimicrobial drug is— 
‘‘(I) a drug— 
‘‘(aa) that— 
‘‘(AA) is approved by the Food and 
Drug Administration; 
‘‘(BB) is designated by the Food and 
Drug Administration as a qualified infec-
tious disease product under subsection (d) 
of section 505E of the Federal Food, 
Drug, and Cosmetic Act; and 
‘‘(CC) has received an extension of its 
exclusivity period pursuant to subsection 
(a) of such section; and 
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‘‘(bb) that has been designated by the Sec-
retary pursuant to the process established 
under clause (iv)(I)(bb); or 
‘‘(II) an antibacterial or antifungal biological 
product— 
‘‘(aa) that is licensed for use, or an anti-
bacterial or antifungal biological product for 
which an indication is first licensed for use, by 
the Food and Drug Administration on or after 
June 5, 2014, under section 351(a) of the Pub-
lic Health Service Act for human use to treat 
serious or life-threatening infections, as deter-
mined by the Food and Drug Administration, 
including those caused by, or likely to be caused 
by— 
‘‘(AA) an antibacterial or antifungal 
resistant pathogen, including novel or 
emerging infectious pathogens; or 
‘‘(BB) a qualifying pathogen (as de-
fined under section 505E(f) of the Federal 
Food, Drug, and Cosmetic Act); and 
‘‘(bb) has been designated by the Secretary 
pursuant to the process established under 
clause (iv)(I)(bb). 
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‘‘(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. 
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(b) AUTHORIZATION OF APPROPRIATIONS FOR THE 
CENTERS FOR DISEASE CONTROL AND PREVENTION.— 
There is authorized to be appropriated to the Centers for 
Disease Control and Prevention $500,000,000, to remain 
available until expended, to support establishment and im-
plementation of antimicrobial stewardship programs and 
data reporting capabilities to the Antimicrobial Use and 
Resistance option of the CDC National Healthcare Safety 
Network, especially in critical access hospitals, rural hos-
pitals, and community hospitals, to support detection, sur-
veillance, containment, and prevention of resistant patho-
gens in the United States and overseas. 
(c) 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 over a 5- 
year period of the barriers that prevent the develop-
ment of DISARM antimicrobial drugs (as defined in 
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section 1886(d)(5)(N)(ii) of the Social Security Act, 
as added by subsection (a)), including— 
(A) patient outcomes in conjunction with 
the use of DISARM drugs, including— 
(i) duration of stay in the intensive 
care unit; 
(ii) recidivism within 30 days; and 
(iii) measures of additional follow up 
care; 
(B) the effectiveness of antimicrobial stew-
ardship and surveillance programs, including— 
(i) changes in the percentage of hos-
pitals in the United States with an anti-
microbial stewardship program in place 
that aligns with the Core Elements of Hos-
pital Antibiotic Stewardship Programs, as 
outlined by the Centers for Disease Control 
and Prevention; 
(ii) changes in inpatient care of 
clostridioides difficile infection; and 
(iii) changes in inpatient rates of re-
sistance to key pathogens; and 
(C) considerations relating to Medicare 
payment reform, including— 
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(i) changes in the number of qualified 
antimicrobial products approved; 
(ii) changes in wholesale acquisition 
cost of individual qualified antimicrobial 
products over time; 
(iii) changes in year-over-year volume 
of individual qualified antimicrobial prod-
ucts sold; and 
(iv) the overall cost of qualified anti-
microbial products to the Medicare pro-
gram as a proportion of total Medicare 
part A spending. 
(2) 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 legisla-
tion and administrative action as the Comptroller 
General determines appropriate. 
Æ 
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