S 2372
340b patients act of 2025
340b Patients Act of 2025
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Bill overview
The 340B Patients Act of 2025 clarifies and strengthens the 340B drug discount program, ensuring that hospitals, clinics, and health centers can continue to access affordable medications for their patients. The bill aims to prevent drug manufacturers from imposing conditions on covered entities that would limit their ability to purchase or receive discounted drugs through contract pharmacies. It also establishes a process for assessing penalties for manufacturers who violate program rules, specifically addressing overcharges and intentional violations.
Key provisions
- Clarifies that drug manufacturers must offer discounted pricing regardless of how a drug is dispensed (e.g., through contract pharmacies).
- Prohibits manufacturers from placing conditions on covered entities’ ability to purchase 340B drugs that would limit delivery or purchasing options.
- Establishes a process for assessing penalties for manufacturers who intentionally violate 340B rules, including civil monetary penalties.
- Defines specific conditions that would be considered unacceptable for manufacturers to impose.
- Addresses contract pharmacies, ensuring the program’s requirements apply when covered entities utilize them.
- Requires the Secretary to establish regulations for assessing penalties within 180 days of the bill’s enactment.
- Allows covered entities to assert claims of violations against manufacturers.
- Amends Section 340B to prevent manufacturers from overcharging covered entities.
Who is affected
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119th CONGRESS — 1st Session
S. 2372
IN THE SENATE OF THE UNITED STATES
A BILL
To ensure the accessibility of drugs furnished through the drug discount program under section 340B of the Public Health Service Act.
This Act may be cited as the 340B Pharmaceutical Access To Invest in Essential, Needed Treatments & Support Act of 2025 340B PATIENTS Act of 2025
or the
.
Congress finds the following:
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.
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.
Covered entities use savings generated through contract pharmacy relationships to stretch scarce resources and support patient care, consistent with the purpose of the program.
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.
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.
The purposes of this Act are the following:
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.
Section 340B(a) of the Public Health Service Act (42 U.S.C. 256b(a)) is amended—
in paragraph (1)—
by striking that the manufacturer furnish
and inserting the following:
that—
the manufacturer furnish
by striking
and inserting ceiling price
), and
;ceiling price
);
by striking shall require that the manufacturer offer
and inserting the following:
the manufacturer offer
by striking the period at the end and inserting the following:
, regardless of the manner or location in which the drug is dispensed; and
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;
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
by adding at the end the following new paragraph:
Section 340B(d) of the Public Health Service Act (42 U.S.C. 256b) is amended—
, in the case of a manufacturer overcharging a covered entity for covered outpatient drugsafter
penalties; and
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;
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;
shall not exceed $2,000,000 for each day of such violation;
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
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.