119-hr4581

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4581 Introduced in House

    (IH) ]

<DOC>

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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