[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9321 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 9321
To direct the Secretary of Health and Human Services to conduct a
demonstration 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
August 6, 2024
Ms. Slotkin (for herself and Mr. Bacon) 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 provisions 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 preferential treatment under
the Medicare, Medicaid, and CHIP programs for certain drugs and
biologicals manufactured in the United States.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``American Made Pharmaceuticals Act of
2024''.
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 PROVIDING PREFERENTIAL
TREATMENT UNDER THE MEDICARE, MEDICAID, AND CHIP PROGRAMS
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 conduct 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:
``(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 Public Health
Service Act; or
``(C) a critical drug.
``(2) Applicable u.s.-based pharmaceutical company.--The
term `applicable U.S.-based pharmaceutical company' means a
manufacturer (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 the manufacturer are
derived from countries other than covered nations (as
defined in section 4871(d)(2) of title 10, United
States Code); and
``(C) that, as determined by the Secretary--
``(i) maintains an appropriate level of
transparency on locations of manufacturing;
``(ii) maintains an appropriate level of
diversity in sourcing;
``(iii) maintains appropriate levels of
inventory and emergency reserves;
``(iv) has in place an appropriate action
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 `applicable tools' means
tools determined appropriate by the Secretary, such as--
``(A) preferential treatment on a formulary;
``(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
``(E) providing bonus payments to providers 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 section
3(c) of Executive Order 13944 of August 6, 2020 (85
Fed. Reg 49929; relating to essential 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 marketed under
section 351(a) of the Public Health Service Act
(or is an active pharmaceutical ingredient of
such a drug or biological);
``(iii) the Secretary determines--
``(I) is--
``(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
supply 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 applicable 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 Program is being conducted, the Secretary shall submit
to Congress a report on activities under the Program, together with
recommendations for such legislation and administrative action as the
Secretary determines to be appropriate.
``(f) Waivers.--The Secretary may waive such provisions 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 authorized to be
appropriated to the Secretary such sums as may be necessary for the
administrative expenses of carrying out the Program, to remain
available until expended.''.
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