cluding for determining the terms and amounts of 
such contracts, established by the Secretary. 
‘‘(d) ANNUAL ANTIMICROBIAL DRUG SPONSOR REV-
ENUE LIMITATIONS.— 
‘‘(1) REPORTING REQUIREMENT.— 
‘‘(A) IN GENERAL.—Not later than a date 
determined appropriate by the Secretary fol-
lowing the end of each calendar year, and not 
earlier than 6 months after the end of each cal-
endar year, the head (or a designee of such 
head) of each Federal agency carrying out a 
specified government program shall, in accord-
ance with this paragraph, report to the Sub-
scription Contract Office established under sec-
tion 399OO(d)(3) the total prescription drug 
sales for each applicable antimicrobial drug 
under contract with respect to such program for 
such calendar year. 
‘‘(B) MEDICARE PART D PROGRAM.—For 
purposes of subparagraph (A), the Secretary 
shall report, for each applicable antimicrobial 
drug covered under part D of title XVIII of the 
Social Security Act, the product of— 
‘‘(i) the per-unit ingredient cost, as 
reported to the Secretary by prescription 
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drug plans and Medicare Advantage pre-
scription drug plans, minus any per-unit 
rebate, discount, or other price concession 
provided by the sponsor of such applicable 
antimicrobial drug, as reported to the Sec-
retary by the prescription drug plans and 
the Medicare Advantage prescription drug 
plans; and 
‘‘(ii) the number of units of such ap-
plicable antimicrobial drug paid for under 
such part D. 
‘‘(C) MEDICARE PART B PROGRAM.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the Secretary shall re-
port, for each applicable antimicrobial drug 
covered under part B of title XVIII of the 
Social Security Act, the product of— 
‘‘(I) the per-unit average sales 
price (as defined in section 1847A(c) 
of such Act) or the per-unit payment 
rate under such part B for a sepa-
rately paid prescription drug without 
a reported average sales price; and 
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‘‘(II) the number of units of such 
applicable antimicrobial drug paid for 
under such part B. 
‘‘(ii) 
UNITS
AND
ALLOCATED 
PRICES.—The Secretary shall establish a 
process for determining the units and the 
allocated price for purposes of this sub-
paragraph 
for 
those 
applicable 
anti-
microbial drugs that are not separately 
payable or for which National Drug Codes 
are not reported. 
‘‘(D) MEDICARE PART A PROGRAM.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), the Secretary shall re-
port, for each applicable antimicrobial drug 
covered under part A of title XVIII of the 
Social Security Act, the product of— 
‘‘(I) the per-unit price under 
such part A for the antimicrobial 
drug; and 
‘‘(II) the number of units of such 
antimicrobial drug paid for under 
such part A. 
‘‘(ii) SPECIAL RULE.—For purposes of 
clause (i), the Secretary shall establish a 
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process for determining the units and the 
allocated price for those prescription drugs 
that are not separately payable or for 
which National Drug Codes are not re-
ported in the diagnosis-related groups. 
‘‘(E) MEDICAID PROGRAM.—Under the au-
thority of section 1902(a)(6) of the Social Secu-
rity Act, the Secretary shall require each State 
that makes medical assistance available under 
the State plan under title XIX of such Act (or 
any waiver of such plan) for an applicable anti-
microbial drug (including, if applicable, any 
such drug which is a covered outpatient drug 
under a rebate agreement entered into under 
section 1927 of such Act) to report, in a form 
consistent with a standard reporting format es-
tablished by the Secretary, not later than the 
date determined under subparagraph (A)— 
‘‘(i) information on the total number 
of units of each dosage form and strength 
and package size of each applicable anti-
microbial drug dispensed during the pre-
ceding calendar year under such State plan 
or waiver (including any such drugs dis-
pensed to an individual enrolled with a 
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medicaid managed care organization or 
other specified entity (as such terms are 
defined in section 1903(m) of such Act)); 
and 
‘‘(ii) with respect to each dosage form 
and strength and package size of each such 
drug, the amount equal to— 
‘‘(I) the product of— 
‘‘(aa) the total number of 
units dispensed under the State 
plan or waiver during the pre-
ceding calendar year (as deter-
mined under clause (i)); and 
‘‘(bb) the per-unit ingredient 
cost paid by the State for each 
such unit; minus 
‘‘(II) any discounts or other price 
concessions provided and rebates paid 
to the State with respect to the dos-
age form and strength and package 
size of such drug and such calendar 
year (including rebates paid under a 
rebate agreement under section 1927 
of such Act and any State supple-
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mental rebates paid under a supple-
mental rebate agreement). 
‘‘(F) DEPARTMENT
OF
VETERANS
AF-
FAIRS.—For purposes of subparagraph (A), the 
Secretary of Veterans Affairs shall report the 
total amount paid for each applicable anti-
microbial drug procured by the Veterans Health 
Administration for individuals who receive 
health care from the Administration. 
‘‘(G) DEPARTMENT
OF
DEFENSE
AND 
TRICARE PROGRAM.—For purposes of subpara-
graph (A), the Secretary of Defense shall report 
the sum of— 
‘‘(i) the total amount paid for each 
applicable antimicrobial drug procured by 
the Department of Defense for individuals 
who receive health care from the Depart-
ment; and 
‘‘(ii) for each applicable antimicrobial 
drug dispensed under the TRICARE retail 
pharmacy 
program 
under 
section 
1074g(a)(2)(E)(ii) of title 10, United 
States Code, the product of— 
‘‘(I) the per-unit ingredient cost, 
minus any per-unit rebate paid by the 
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sponsor of the applicable antimicrobial 
drug; and 
‘‘(II) the number of units of such 
applicable antimicrobial drug dis-
pensed under such program. 
‘‘(H) DEPARTMENT OF HOMELAND SECU-
RITY.—For purposes of subparagraph (A), the 
Secretary of Homeland Security shall report the 
total amount paid for each applicable anti-
microbial drug procured by the Department of 
Homeland Security for individuals who receive 
health care through a program carried out by 
the Department. 
‘‘(I) BUREAU OF PRISONS.—For purposes 
of subparagraph (A), the Director of the Bu-
reau of Prisons shall report the total amount 
paid for each applicable antimicrobial drug pro-
cured by the Bureau of Prisons for individuals 
who receive health care through the Bureau. 
‘‘(J) INDIAN HEALTH SERVICE.—For pur-
poses of subparagraph (A), the Secretary, act-
ing through the Indian Health Service, shall re-
port the total amount paid for each applicable 
antimicrobial drug procured by the Service for 
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individuals who receive health care through the 
Service. 
‘‘(2) REGULATIONS.—Not later than 1 year 
after the date of enactment of this part, the Sec-
retary, in consultation with the heads of Federal 
agencies carrying out specified government pro-
grams, shall issue regulations to assist such heads 
(or their designees) in carrying out the requirements 
under this section. 
‘‘(3) SUBSCRIPTION CONTRACT ADJUSTMENT.— 
Pursuant to the contract entered into under this sec-
tion with respect to an applicable antimicrobial drug, 
for each year of the term of such contract, the Sec-
retary shall, not earlier than 6 months after the end 
of each calendar year, subtract from the payment in-
stallments determined for such contract under sub-
section (c)(1) for such year the revenue of the spon-
sor of such drug from the previous year from sales 
of the applicable antimicrobial drug reported under 
paragraph (1) for specified government programs. 
‘‘(4) DEFINITIONS.—In this subsection: 
‘‘(A) 
APPLICABLE
ANTIMICROBIAL 
DRUG.—The 
term 
‘applicable 
antimicrobial 
drug’ means an antimicrobial drug for which 
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the sponsor of such drug receives a subscription 
contract under subsection (a). 
‘‘(B) 
SPECIFIED
GOVERNMENT
PRO-
GRAM.—The term ‘specified government pro-
gram’ means— 
‘‘(i) the Medicare part D program 
under part D of title XVIII of the Social 
Security Act; 
‘‘(ii) the Medicare Part B program 
under part B of such title XVIII; 
‘‘(iii) the Medicare Part A program 
under part A of such title XVIII; 
‘‘(iv) the Medicaid program estab-
lished under title XIX of the Social Secu-
rity Act and includes, with respect to a 
State, any waiver in effect with respect to 
such program; 
‘‘(v) any program under which pre-
scription drugs are procured by the De-
partment of Veterans Affairs; 
‘‘(vi) any program under which pre-
scription drugs are procured by the De-
partment of Defense; 
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‘‘(vii) the TRICARE retail pharmacy 
program under section 1074g(a)(2)(E)(ii) 
of title 10, United States Code; 
‘‘(viii) any program under which pre-
scription drugs are procured by the De-
partment of Homeland Security; 
‘‘(ix) any program under which pre-
scription drugs are procured by the Bu-
reau of Prisons; or 
‘‘(x) any program under which pre-
scription drugs are procured by the Indian 
Health Service. 
‘‘(e) FAILURE TO ADHERE TO TERMS.—The Sec-
retary shall cease any payment installments under a con-
tract under this section if— 
‘‘(1) the sponsor— 
‘‘(A) permanently withdraws the anti-
microbial drug from the market in the United 
States; 
‘‘(B) fails to meet criteria under subsection 
(b); or 
‘‘(C) does not complete a postmarket study 
required by the Food and Drug Administration 
during the length of the term of the contract; 
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‘‘(2) the annual international and private insur-
ance market revenues with respect to an anti-
microbial drug (not counting any subscription reve-
nues from any source pursuant to a contract under 
this section or other international or private entities) 
exceed 5 times the average annual amount of the 
subscription contract paid by the Secretary as cer-
tified by the sponsor annually; or 
‘‘(3) if the total revenue of the sponsor from 
specified government programs, as defined in sub-
section (d)(4), for a year exceeds the amount of the 
subscription contract paid by the Secretary for that 
year. 
‘‘(f) PRIVATE PAYER AND INTERNATIONAL PAYER 
PARTICIPATION.—The Secretary shall make efforts to in-
crease the participation of domestic private payors and 
international payors in subscription contracts or other 
types of value-based arrangements that are similar to the 
subscription contracts authorized under this section. 
‘‘SEC. 399RR. ENCOURAGING APPROPRIATE USE OF ANTI-
BIOTICS AND COMBATING RESISTANCE. 
‘‘(a) ESTABLISHMENT OF HOSPITAL GRANT PRO-
GRAM.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this part, the Secretary and 
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the Director of the Centers for Disease Control and 
Prevention shall coordinate with the Administrator 
of the Health Resources and Services Administra-
tion, the Administrator of the Centers for Medicare 
& Medicaid Services, the National Coordinator for 
Health Information Technology, and other relevant 
agencies, to establish a grant program under the 
Centers for Disease Control and Prevention to sup-
port hospital and other inpatient facility efforts— 
‘‘(A) to judiciously use antimicrobial drugs, 
such as by establishing or implementing appro-
priate use programs, including infectious dis-
ease telehealth programs, using appropriate di-
agnostic tools, partnering with academic hos-
pitals, increasing health care-associated infec-
tion reporting, and monitoring antimicrobial re-
sistance; and 
‘‘(B) to participate in the National 
Healthcare Safety Network Antimicrobial Use 
and Resistance Module or the Emerging Infec-
tions Program Healthcare-Associated Infections 
Community Interface activity of the Centers for 
Disease Control and Prevention or a similar re-
porting program, as specified by the Secretary, 
relating to antimicrobial drugs. 
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‘‘(2) PRIORITIZATION.—In awarding grants 
under paragraph (1), the Secretary shall prioritize 
hospitals without an existing program to judiciously 
use antimicrobial drugs, subsection (d) hospitals (as 
defined in subparagraph (B) of section 1886(d)(2) 
of the Social Security Act that are located in rural 
areas (as defined in subparagraph (D) of such sec-
tion), critical access hospitals (as defined in section 
1861(mm)(1) of such Act), hospitals serving Tribal- 
populations, and safety-net hospitals. 
‘‘(3) FUNDING.—Of the amounts appropriated 
under section 399SS, the Secretary shall reserve 
$500,000,000 to carry out this subsection. 
‘‘(b) SURVEILLANCE AND REPORTING OF ANTIBIOTIC 
USE AND RESISTANCE.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall use the National 
Healthcare Safety Network and other appropriate 
surveillance systems to assess— 
‘‘(A) appropriate conditions, outcomes, and 
measures causally related to antibacterial resist-
ance, including types of infections, the causes 
for infections, and whether infections are ac-
quired in a community or hospital setting, in-
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creased lengths of hospital stay, increased costs, 
and rates of mortality; and 
‘‘(B) changes in bacterial resistance to 
antimicrobial drugs in relation to patient out-
comes, including changes in percent resistance, 
prevalence of antibiotic-resistant infections, and 
other such changes. 
‘‘(2) ANTIBIOTIC
USE
DATA.—The Secretary, 
acting through the Director of the Centers for Dis-
ease Control and Prevention, shall work with Fed-
eral agencies (including the Department of Veterans 
Affairs, the Department of Defense, the Department 
of Homeland Security, the Bureau of Prisons, the 
Indian Health Service, and the Centers for Medicare 
& Medicaid Services), private vendors, health care 
organizations, pharmacy benefit managers, and 
other entities as appropriate to obtain reliable and 
comparable human antibiotic drug consumption data 
(including, as available and appropriate, volume an-
tibiotic distribution data and antibiotic use data, in-
cluding prescription data) by State or metropolitan 
areas. 
‘‘(3) ANTIBIOTIC RESISTANCE TREND DATA.— 
The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, shall in-
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tensify and expand efforts to collect antibiotic resist-
ance data and encourage adoption of the Antibiotic 
Use and Resistance Module within the National 
Healthcare Safety Network among all health care fa-
cilities across the continuum of care, including, as 
appropriate, acute care hospitals, dialysis facilities, 
nursing homes, ambulatory surgical centers, and 
other ambulatory health care settings in which anti-
microbial drugs are routinely prescribed. The Sec-
retary shall seek to collect such data from electronic 
medication administration reports and laboratory 
systems to produce the reports described in para-
graph (4). 
‘‘(4) PUBLIC
AVAILABILITY
OF
DATA.—The 
Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall, for 
the purposes of improving the monitoring of impor-
tant trends in patient outcomes in relation to anti-
bacterial resistance— 
‘‘(A) make the data derived from surveil-
lance under this subsection publicly available 
through reports issued on a regular basis that 
is not less than annually; and 
‘‘(B) examine opportunities to make such 
data available in near real time. 
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‘‘SEC. 399SS. APPROPRIATIONS. 
‘‘(a) IN GENERAL.—To carry out this part, there are 
hereby appropriated to the Secretary, out of amounts in 
the 
Treasury 
not 
otherwise 
appropriated, 
$11,000,000,000, for fiscal year 2022, to remain available 
until expended. 
‘‘(b) EMERGENCY DESIGNATION.— 
‘‘(1) IN GENERAL.—The amounts provided by 
this section are designated as an emergency require-
ment pursuant to section 4(g) of the Statutory Pay- 
As-You-Go Act of 2010. 
‘‘(2) DESIGNATION IN SENATE.—In the Senate, 
this section is designated as an emergency require-
ment pursuant to section 4112(a) of H. Con. Res. 
71 (115th Congress), the concurrent resolution on 
the budget for fiscal year 2018. 
‘‘SEC. 399TT. STUDIES AND REPORTS. 
‘‘(a) IN GENERAL.—Not later than 6 years after the 
date of enactment of this part, the Comptroller General 
of the United States shall complete a study on the effec-
tiveness of this part in developing priority antimicrobial 
drugs. Such study shall examine the indications for, usage 
of, development of resistance with respect to, and private 
and societal value of critical need antimicrobial drugs, and 
the impact of the programs under this part on patients 
and markets of critical need antimicrobial drugs. The 
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Comptroller General shall report to the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House 
of Representatives on the findings of such study. 
‘‘(b) ANTIBIOTIC USE IN THE UNITED STATES; AN-
NUAL REPORTS.—The Director of the Centers for Disease 
Control and Prevention shall, each year, update the report 
entitled ‘Antibiotic Use in the United States’ to include 
updated information on progress and opportunities with 
respect to data, programs, and resources for prescribers 
to promote appropriate use of antimicrobial drugs. 
‘‘(c) REPORT ON ANTIMICROBIAL PROPHYLACTICS.— 
Not later than 3 years after the date of enactment of this 
part, the Director of the Centers for Disease Control and 
Prevention shall publish a report on antimicrobial prophy-
lactics. 
‘‘SEC. 399UU. DEFINITIONS. 
‘‘In this part— 
‘‘(1) the term ‘antimicrobial drug’— 
‘‘(A) means, subject to subparagraph (B), 
a product that is— 
‘‘(i) a drug that directly inhibits rep-
lication of or kills bacteria or fungi rel-
evant to the proposed indication at con-
centrations likely to be attainable in hu-
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mans to achieve the intended therapeutic 
effect; or 
‘‘(ii) a biological product that acts di-
rectly on bacteria or fungi or on the sub-
stances produced by such bacteria or fungi; 
and 
‘‘(B) does not include— 
‘‘(i) a drug that achieves the effect de-
scribed by subparagraph (A)(i) only at a 
concentration that cannot reasonably be 
studied in humans because of its antici-
pated toxicity; or 
‘‘(ii) a vaccine; and 
‘‘(2) the term ‘Committee’ means the Com-
mittee on Critical Need Antimicrobials established 
under section 399OO.’’. 
Æ 
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