I 
117TH CONGRESS 
2D SESSION 
H. R. 7400 
To direct the Secretary of Health and Human Services to conduct a dem-
onstration program to test providing preferential treatment under the 
Medicare, Medicaid, and CHIP programs for certain drugs and 
biologicals manufactured in the United States. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 5, 2022 
Ms. CRAIG (for herself and Mr. MULLIN) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committee on Ways and Means, 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 direct the Secretary of Health and Human Services to 
conduct a demonstration program to test providing pref-
erential treatment under the Medicare, Medicaid, and 
CHIP programs for certain drugs and biologicals manu-
factured in the United States. 
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 ‘‘American Made Phar-
maceuticals Act of 2022’’. 
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SEC. 2. DEMONSTRATION PROGRAM TO TEST PROVIDING 
PREFERENTIAL 
TREATMENT 
UNDER 
THE 
MEDICARE, MEDICAID, AND CHIP PROGRAMS 
FOR CERTAIN DRUGS AND BIOLOGICALS 
MANUFACTURED IN THE UNITED STATES. 
Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.) is amended by inserting after section 
1150C the following: 
‘‘SEC. 1150D. DEMONSTRATION PROGRAM TO TEST PRO-
VIDING PREFERENTIAL TREATMENT UNDER 
THE MEDICARE, MEDICAID, AND CHIP PRO-
GRAMS 
FOR 
CERTAIN 
DRUGS 
AND 
BIOLOGICALS 
MANUFACTURED 
IN 
THE 
UNITED STATES. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary shall con-
duct a demonstration program (in this section referred to 
as the ‘Program’) under which U.S. manufactured drugs 
are given preference under titles XVIII, XIX, and XXI 
compared to drugs that are not U.S. manufactured drugs 
through the use of applicable tools. 
‘‘(b) SITES.—The Program shall be conducted in at 
least 8 States. 
‘‘(c) DURATION.—The Secretary shall conduct the 
Program for a period of not less than 7 years. 
‘‘(d) DEFINITIONS.—In this section: 
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‘‘(1) APPLICABLE DRUG.—The term ‘applicable 
drug’ means— 
‘‘(A) a drug that is approved and marketed 
under section 505(j) of the Federal Food, 
Drug, and Cosmetic Act; 
‘‘(B) a biological product that is licensed 
and marketed under section 351(k) of the Pub-
lic Health Service Act; or 
‘‘(C) a critical drug. 
‘‘(2) 
APPLICABLE
U.S.-BASED
PHARMA-
CEUTICAL
COMPANY.—The term ‘applicable U.S.- 
based pharmaceutical company’ means a manufac-
turer (as defined in section 1860D–14A(g)(5))— 
‘‘(A) that has a manufacturing location in 
the United States for an applicable drug; 
‘‘(B) beginning 3 years after the date of 
the implementation of the Program, for which 
at least 50 percent of the starter products, by 
weight, for the applicable drugs manufactured 
by manufacturer are derived from countries 
other than covered nations (as defined in sec-
tion 4871(d)(2) of title 10, United States 
Code); and 
‘‘(C) that, as determined by the Sec-
retary— 
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‘‘(i) maintains an appropriate level of 
transparency on locations of manufac-
turing; 
‘‘(ii) maintains an appropriate level of 
diversity in sourcing; 
‘‘(iii) maintains appropriate levels of 
inventory and emergency reserves; 
‘‘(iv) has in place an appropriate ac-
tion plan for increases in demand and for 
when links in the supply chain break down; 
and 
‘‘(v) meets any other characteristics 
the Secretary determines appropriate. 
‘‘(3) APPLICABLE TOOLS.—The term ‘applica-
ble tools’ means tools determined appropriate by the 
Secretary, such as— 
‘‘(A) preferential treatment on a for-
mulary; 
‘‘(B) providing lower cost-sharing; 
‘‘(C) waiving rebates under the Medicaid 
program under title XIX; 
‘‘(D) establishing a Medicare Star Rating 
under part D of title XVIII; or 
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‘‘(E) providing bonus payments to pro-
viders of services and suppliers under part B of 
title XVIII. 
‘‘(4) CRITICAL DRUG.—In this section, the term 
‘critical drug’ includes the following: 
‘‘(A) A medicine, medical countermeasure, 
or critical input identified on the list under sec-
tion 3(c) of Executive Order 13944 of August 
6, 2020 (85 Red. Reg 49929; relating to essen-
tial medicines, medical Countermeasures, and 
critical inputs). 
‘‘(B) A drug or biological that— 
‘‘(i) is not described in subparagraph 
(A); 
‘‘(ii) is approved and marketed under 
section 505(c) of the Federal Food, Drug, 
and Cosmetic Act or is licensed and mar-
keted under section 351(a) of the Public 
Health Service Act (or is an active phar-
maceutical ingredient of such a drug or bi-
ological); and 
‘‘(iii) the Secretary determines— 
‘‘(I) is— 
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‘‘(aa) likely to be needed for 
use in a public health emergency; 
or 
‘‘(bb) at high risk of short 
supply; and 
‘‘(II) has a vulnerable global sup-
ply chain. 
‘‘(5) U.S. MANUFACTURED
DRUG.—The term 
‘U.S. manufactured drug’ means an applicable drug 
that is manufactured in the United States by an ap-
plicable U.S.-based pharmaceutical company. 
‘‘(e) ANNUAL REPORT
TO CONGRESS.—Not later 
than 1 year after the date the Secretary implements the 
Program, and annually thereafter for as long as the Pro-
gram is being conducted, the Secretary shall submit to 
Congress a report on activities under the Program, to-
gether with recommendations for such legislation and ad-
ministrative action as the Secretary determines to be ap-
propriate. 
‘‘(f) WAIVERS.—The Secretary may waive such provi-
sions of this title and titles XVIII, XIX, and XXI as the 
Secretary determines necessary in order to implement the 
Program. 
‘‘(g) ADMINISTRATIVE FUNDING.—There is author-
ized to be appropriated to the Secretary such sums as may 
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be necessary for the administrative expenses of carrying 
out the Program, to remain available until expended.’’. 
Æ 
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