I 
118TH CONGRESS 
2D SESSION 
H. R. 7635 
To amend title III of the Social Security Act to ensure the accessibility 
of drugs furnished under the 340B drug discount program. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 12, 2024 
Ms. MATSUI introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend title III of the Social Security Act to ensure 
the accessibility of drugs furnished under the 340B drug 
discount program. 
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 340B Pharmaceutical 
Access To Invest in Essential, Needed Treatments & Sup-
port Act of 2024’’ or ‘‘The 340B PATIENTS Act of 
2024’’. 
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 without such program; 
(2) Section 340B requires drug manufacturers 
to offer discounted prices on covered outpatient 
drugs to covered entities participating in the pro-
gram, as a condition of participating in the Medicaid 
or Medicare Part B programs, and drug manufac-
turers must offer 340B pricing to covered entities 
and sell 340B and deliver 340B drugs to covered en-
tities when requested irrespective of the manner or 
location through which a 340B drug is dispensed. 
(3) Savings from section 340B enables hos-
pitals, clinics, and health centers’ to provide com-
prehensive services to the communities they serve, 
and covered entities are in the best position to as-
sess the use of their savings for community needs. 
(4) Since the early years of the 340B program, 
covered entities have contracted with pharmacies to 
dispense covered outpatient drugs purchased by a 
covered entity at 340B pricing to patients of the 
covered entity, consistent with how Congress in-
tended for covered entities to use the program. 
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(5) Covered entities use savings generated 
through 340B contract pharmacy relationships to 
stretch scarce resources and support patient care, 
consistent with the purpose of the program. 
(6) Section 340B requires drug manufacturers 
to offer 340B pricing for drugs purchased by cov-
ered entities regardless of the manner or location in 
which a drug is dispensed, including drugs dispensed 
through contract pharmacies. 
(7) Section 340B does not allow drug manufac-
turers to place conditions on the ability of a covered 
entity to purchase or use a covered outpatient drug 
at 340B pricing regardless of the manner or location 
in which a drug is dispensed, including by restricting 
a covered entity’s ability to dispense 340B drugs to 
patients through a contractual relationship with a 
contracted pharmacy or refusing to ship covered out-
patient drugs to a pharmacy or location identified by 
a covered entity. 
(8) Section 340B’s inflationary penalty provi-
sions, which have saved $7 billion in Medicare Part 
D spending between 2013 and 2017, have a proven 
record of reducing drug price increases, and use of 
340B in contract pharmacies contributes to these 
savings. 
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(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 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) requires drug 
manufacturers to offer 340B pricing for drugs pur-
chased by a covered entity regardless of the manner 
or location in which the drug is dispensed, and sec-
tion 340B prohibits drug manufacturers from plac-
ing conditions on the ability of covered entities to 
purchase and use 340B drugs, regardless of the 
manner or location in which they are dispensed. 
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(2) To clarify that covered entities under sec-
tion 340B may contract with pharmacies to dispense 
on a covered entity’s behalf drugs purchased by a 
covered entity under section 340B to generate sav-
ings to assist covered entities to stretch resources to 
provide care to more patients and provide more com-
prehensive services, and the requirements and prohi-
bitions that apply to manufacturers under section 
340B apply in the case of a covered entity that 
elects to contract with a pharmacy to dispense 340B 
drugs. 
SEC. 3. ENSURING THE ACCESSIBILITY OF DRUGS FUR-
NISHED UNDER THE 340B DRUG DISCOUNT 
PROGRAM. 
(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 
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(D) by striking the period at the end and 
inserting the following: ‘‘, regardless of the 
manner or location in which the drug is dis-
pensed; and 
‘‘(C) the manufacturer not place conditions 
on the ability of a covered entity to purchase 
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, including but not limited to placing lim-
its on the delivery of drugs, placing limits on 
the mechanisms through which drugs may be 
purchased, placing limits on where such drugs 
may be delivered, administered, or dispensed, 
requiring a covered entity’s assurance of com-
pliance with requirements under this section, or 
requiring the submission of claims data or other 
information, except that, notwithstanding this 
subparagraph, the manufacturer may impose 
such conditions after receiving advance approval 
from the Secretary (or, with respect to condi-
tions specified by the Secretary, without such 
advance approval) if such conditions would not 
discourage covered entities from purchasing the 
manufacturer’s drugs through the drug dis-
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count program under this section or otherwise 
undermine the objective of this section, either 
by singling out covered entities from other cus-
tomers for such conditions or by imposing con-
ditions that disproportionately impact covered 
entities.’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(11) CONTRACT
PHARMACIES.—The require-
ments and prohibitions under subsection (a)(1) shall 
apply, in the case of a covered entity that elects to 
contract with one or more pharmacies to dispense 
covered outpatient drugs purchased by a covered en-
tity at or below the applicable ceiling price described 
in paragraph (1), to patients of the covered entity.’’. 
(b) 
MANUFACTURER
COMPLIANCE.—Section 
340B(d) of the Public Health Service Act (42 U.S.C. 
256b) is amended— 
(1) in paragraph (1)(B)(vi), by inserting ‘‘in 
the case of an overcharge’’ after ‘‘penalties’’; 
(2) in paragraph (1)(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) or 
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subsection (a)(11), other than an over-
charge, 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; 
‘‘(II) shall apply to any manufac-
turer with an agreement under this 
section that knowingly and inten-
tionally violates a requirement under 
subsection 
(a)(1) 
or 
subsection 
(a)(11), other than an overcharge; 
‘‘(III) 
shall 
not 
exceed 
$2,000,000 for each day of such viola-
tion; 
‘‘(IV) shall be determined by the 
Secretary, taking into account factors 
such as the nature and extent of the 
violation and harm resulting from 
such violation, including, where appli-
cable, the number of drugs affected 
and the number of covered entities af-
fected; and 
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‘‘(V) shall continue to be imposed 
each day until such manufacturer is 
no longer in violation of a requirement 
under subsection (a)(1) or subsection 
(a)(11), other than an overcharge.’’; 
and 
(3) in paragraph (3), by adding at the end the 
following: 
‘‘(D) Not later than 180 days after the 
date of the enactment of this subparagraph, the 
Secretary shall promulgate regulations to per-
mit covered entities to assert claims of viola-
tions of subsection (a)(1) and subsection 
(a)(11) under the process promulgated under 
subparagraph (A).’’. 
Æ 
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