I 
119TH CONGRESS 
1ST SESSION H. R. 4581 
To ensure the accessibility of drugs furnished through the drug discount 
program under section 340B of the Public Health Service Act. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 22, 2025 
Ms. MATSUI (for herself, Mrs. TRAHAN, Mr. TONKO, Ms. DAVIDS of Kansas, 
Ms. MCCOLLUM, Mr. THANEDAR, Ms. TLAIB, Mr. FROST, and Ms. CAS-
TOR of Florida) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To ensure the accessibility of drugs furnished through the 
drug discount program under section 340B of the Public 
Health Service Act. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SEC. 1. SHORT TITLE. 
This Act may be cited as the ‘‘340B Pharmaceutical 
Access To Invest in Essential, Needed Treatments & Sup-
port Act of 2025’’ or the ‘‘340B PATIENTS Act of 
2025’’. 
SEC. 2. FINDINGS AND PURPOSES. 
(a) FINDINGS.—Congress finds the following: 
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(1) Section 340B of the Public Health Service 
Act (42 U.S.C. 256b) enables covered entities to 
stretch scarce resources as far as possible, reaching 
more patients and providing more comprehensive 
services than would be possible without such pro-
gram. 
(2) Such section 340B requires drug manufac-
turers to offer discounted prices on covered out-
patient drugs to covered entities participating in the 
program, and, as a condition of participating in the 
Medicaid program and part B of the Medicare pro-
gram, drug manufacturers are required to offer drug 
discount pricing to covered entities when requested. 
(3) Savings on the purchase of drugs under the 
drug discount program under section 340B of the 
Public Health Service Act enables hospitals, clinics, 
and health centers to provide comprehensive services 
to the communities they serve, and covered entities 
are in the best position to assess the use of their 
savings for community needs. 
(4) Since the early years of such program, cov-
ered entities have contracted with pharmacies to dis-
pense covered outpatient drugs purchased by a cov-
ered entity at drug discount program pricing to pa-
tients of the covered entity, consistent with how 
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Congress intended for covered entities to use the 
program. 
(5) Covered entities use saving generated 
through contract pharmacy relationships to stretch 
scarce resources and support patient care, consistent 
with the purpose of the program. 
(6) Section 340B of the Public Health Service 
Act requires drug manufacturers to offer discount 
pricing for drugs purchased by covered entities re- 
gardless of the manner or location in which a drug 
is dispensed, including drugs dispensed through con- 
tract pharmacies. 
(7) Such section 340B does not allow drug 
manufacturers to place conditions on the ability of 
a covered entity to purchase or use a covered out- 
patient drug at discounted pricing regardless of the 
manner or location in which a drug is dispensed, in-
cluding by restricting a covered entity’s ability to 
dispense drugs purchased at such discount to pa-
tients through a contractual relationship with a con-
tracted pharmacy or refusing to ship covered out-
patient drugs to a pharmacy or location identified by 
a covered entity. 
(8) The inflationary penalty provisions under 
section 340B of the Public Health Service Act, 
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which have saved $7,000,000,000 in spending under 
part D of the Medicare program between 2013 and 
2017, have a proven record of reducing drug price 
increases, and use of the drug discount program in 
contract pharmacies contributes to these savings. 
(9) Specialty drugs, which are often used to 
treat chronic, serious, or life-threatening conditions 
such as cancer, rheumatoid arthritis, growth hor-
mone deficiency, and multiple sclerosis, play a crit-
ical role in the care provided by covered entities. 
These drugs often require specialized handling, are 
not usually available to walk-in customers, and are 
typically available only through specialty or mail 
order pharmacies that are located hundreds of miles 
from a covered entity. The use of contract pharmacy 
arrangements under section 340B of the Public 
Health Service Act are often the only means by 
which covered entities can access these vital drugs. 
(b) PURPOSES.—The purposes of this Act are the fol-
lowing: 
(1) To clarify that section 340B of the Public 
Health Service Act (42 U.S.C. 256b)— 
(A) requires drug manufacturers to offer 
drug discount pricing pursuant to an agreement 
under subsection (a) of such section with re-
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spect to drugs purchased by a covered entity re-
gardless of the manner or location in which the 
drug is dispensed; and 
(B) prohibits drug manufacturers from 
placing conditions on the ability of covered enti-
ties to purchase covered outpatient drugs pur-
suant to an agreement under subsection (a) of 
such section, regardless of the manner or loca-
tion in which they are dispensed. 
(2) To clarify that— 
(A) covered entities may contract with 
pharmacies to dispense drugs purchased pursu-
ant to an agreement under section 340B(a) of 
the Public Health Service Act (42 U.S.C. 
256b(a)) on a covered entity’s behalf, to assist 
covered entities in stretching resources to pro-
vide care to more patients and provide more 
comprehensive services; and 
(B) the requirements and prohibitions that 
apply to manufacturers under section 340B of 
such Act apply in the case of a covered entity 
that elects to contract with a pharmacy to dis-
pense covered outpatient drugs. 
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SEC. 3. ENSURING THE ACCESSIBILITY OF DRUGS FUR-
NISHED UNDER THE DRUG DISCOUNT PRO- 
GRAM. 
(a) IN GENERAL.—Section 340B(a) of the Public 
Health Service Act (42 U.S.C. 256b(a)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘that the manufacturer 
furnish’’ and inserting the following: ‘‘that— 
‘‘(A) the manufacturer furnish’’; 
(B) by striking ‘‘ ‘ceiling price’), and’’ and 
inserting ‘‘ ‘ceiling price’);’’; 
(C) by striking ‘‘shall require that the 
manufacturer offer’’ and inserting the following: 
‘‘(B) the manufacturer offer’’; and 
(D) by striking the period at the end and 
inserting the following:’’, regardless of the man-
ner or location in which the drug is dispensed; 
and 
‘‘(C) the manufacturer not place any con-
ditions on the ability of a covered entity to pur-
chase and use a covered outpatient drug at or 
below the applicable ceiling price, regardless of 
the manner or location in which the drug is dis-
pensed, if such conditions— 
‘‘(i) would place limits on the delivery 
of drugs, place limits on the mechanisms 
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through which drugs may be purchased, 
place limits on where such drugs may be 
delivered, administered, or dispensed, re-
quire a covered entity’s assurance of com-
pliance with requirements under this sec-
tion, or require the submission of claims 
data or other information; 
‘‘(ii) would not reflect customary busi-
ness practices; 
‘‘(iii) would discourage covered enti-
ties from purchasing the manufacturer’s 
drugs through the drug discount program 
under this section or otherwise undermine 
the objective of this section, either by sin-
gling out covered entities from other cus-
tomers for such conditions or by imposing 
conditions that disproportionately impact 
covered entities; or 
‘‘(iv) have not been approved in ad-
vance by the Secretary.’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(11) CONTRACT
PHARMACIES.—The require-
ments and prohibitions under paragraph (1) shall 
apply in the case of a covered entity that elects to 
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contract with one or more pharmacies to dispense, to 
patients of the covered entity, covered outpatient 
drugs purchased by the covered entity at or below 
the applicable ceiling price described in paragraph 
(1).’’. 
(b) 
MANUFACTURER
COMPLIANCE.—Section 
340B(d) of the Public Health Service Act (42 U.S.C. 
256b) is amended— 
(1) in paragraph (1)(B)— 
(A) in clause (vi), in the matter preceding 
subclause (I), by inserting ‘‘, in the case of a 
manufacturer overcharging a covered entity for 
covered outpatient drugs’’ after ‘‘penalties’’; 
and 
(B) by adding at the end the following: 
‘‘(vii) The imposition of sanctions in 
the form of civil monetary penalties in the 
case of a violation of subsection (a)(1)(C) 
or (a)(11), other than an overcharge, 
which— 
‘‘(I) shall be assessed according 
to standards established in regulations 
to be promulgated by the Secretary 
not later than 180 days after the date 
of enactment; 
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‘‘(II) shall apply to any manufac-
turer with an agreement under this 
section that intentionally violates a re-
quirement under subsection (a)(1)(C) 
or (a)(11), other than an overcharge; 
‘‘(III) 
shall 
not 
exceed 
$2,000,000 for each day of such viola-
tion; 
‘‘(IV) shall be in an amount de-
termined by the Secretary, taking into 
account factors such as the nature 
and extent of the violation and harm 
resulting from such violation, includ-
ing, where applicable, the number of 
drugs affected and the number of cov-
ered entities affected; and 
‘‘(V) shall continue to be imposed 
each day until such manufacturer is 
no longer in violation of a requirement 
under subsection (a)(1)(C) or (a)(11), 
other than an overcharge.’’; and 
(2) in paragraph (3), by adding at the end the 
following: 
‘‘(D) CLAIMS OF VIOLATIONS.—Not later 
than 180 days after the date of the enactment 
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of this subparagraph, the Secretary shall pro-
mulgate regulations to permit covered entities 
to assert claims of violations of subsections 
(a)(1) and (a)(11) under the process established 
under subparagraph (A).’’. 
Æ 
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