1458 
tious disease product under subsection (d) 
of section 505E of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 
355f(d)); and 
‘‘(CC) has received an extension of its 
exclusivity period pursuant to subsection 
(a) of such section; and 
‘‘(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 
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‘‘(BB) a qualifying pathogen (as de-
fined under section 505E(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
355f(f))); and 
‘‘(bb) has been designated by the Secretary 
pursuant to the process established under 
clause (iv)(I)(bb). 
‘‘(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 
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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. 
‘‘(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 
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‘‘(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 
‘‘(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, 2024, 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-
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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— 
‘‘(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-
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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 (N)(vi), provide’’. 
(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 the establishment and 
implementation 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 hospitals, and community hospitals, to support de-
tection, surveillance, containment, and prevention of re-
sistant pathogens 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’’), in consultation with the Di-
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