[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4581 Introduced in House (IH)]
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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. Castor 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 Representatives 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 & Support Act of 2025'' or the ``340B
PATIENTS Act of 2025''.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--Congress finds the following:
(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 program.
(2) Such section 340B requires drug manufacturers to offer
discounted prices on covered outpatient drugs to covered
entities participating in the program, and, as a condition of
participating in the Medicaid program and part B of the
Medicare program, 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, covered entities
have contracted with pharmacies to dispense covered outpatient
drugs purchased by a covered entity at drug discount program
pricing to patients of the covered entity, consistent with how
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, including by restricting a covered entity's ability
to dispense drugs purchased at such discount to patients
through a contractual relationship with a contracted pharmacy
or refusing to ship covered outpatient 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, 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 hormone deficiency, and multiple
sclerosis, play a critical 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 following:
(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 respect to drugs
purchased by a covered entity regardless of the manner
or location in which the drug is dispensed; and
(B) prohibits drug manufacturers from placing
conditions on the ability of covered entities to
purchase covered outpatient drugs pursuant to an
agreement under subsection (a) of such section,
regardless of the manner or location in which they are
dispensed.
(2) To clarify that--
(A) covered entities may contract with pharmacies
to dispense drugs purchased pursuant 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
provide 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 dispense covered outpatient drugs.
SEC. 3. ENSURING THE ACCESSIBILITY OF DRUGS FURNISHED 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 manner or location
in which the drug is dispensed; and
``(C) the manufacturer not place any 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 dispensed, if such conditions--
``(i) would place limits on the delivery of
drugs, place limits on the mechanisms through
which drugs may be purchased, place limits on
where such drugs may be delivered,
administered, or dispensed, require a covered
entity's assurance of compliance with
requirements under this section, or require the
submission of claims data or other information;
``(ii) would not reflect customary business
practices;
``(iii) would discourage covered entities
from purchasing the manufacturer's drugs
through the drug discount program under this
section or otherwise undermine the objective of
this section, either by singling out covered
entities from other customers for such
conditions or by imposing conditions that
disproportionately impact covered entities; or
``(iv) have not been approved in advance by
the Secretary.''; and
(2) by adding at the end the following new paragraph:
``(11) Contract pharmacies.--The requirements and
prohibitions under paragraph (1) shall apply in the case of a
covered entity that elects to 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;
``(II) shall apply to any
manufacturer with an agreement under
this section that intentionally
violates a requirement under subsection
(a)(1)(C) or (a)(11), other than an
overcharge;
``(III) shall not exceed $2,000,000
for each day of such violation;
``(IV) shall be in an amount
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 applicable, the number
of drugs affected and the number of
covered 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 of this
subparagraph, the Secretary shall promulgate
regulations to permit covered entities to assert claims
of violations of subsections (a)(1) and (a)(11) under
the process established under subparagraph (A).''.
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