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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7635 Introduced in House (IH)]
<DOC>
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 Representatives 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 & Support Act of 2024'' or ``The 340B
PATIENTS Act of 2024''.
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 without such
program;
(2) Section 340B requires drug manufacturers to offer
discounted prices on covered outpatient drugs to covered
entities participating in the program, as a condition of
participating in the Medicaid or Medicare Part B programs, and
drug manufacturers must offer 340B pricing to covered entities
and sell 340B and deliver 340B drugs to covered entities when
requested irrespective of the manner or location through which
a 340B drug is dispensed.
(3) Savings from section 340B 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 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
intended for covered entities to use the program.
(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 covered 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 manufacturers 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 outpatient
drugs to a pharmacy or location identified by a covered entity.
(8) Section 340B's inflationary penalty provisions, 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.
(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 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) requires drug manufacturers to
offer 340B pricing for drugs purchased by a covered entity
regardless of the manner or location in which the drug is
dispensed, and section 340B prohibits drug manufacturers from
placing conditions on the ability of covered entities to
purchase and use 340B drugs, regardless of the manner or
location in which they are dispensed.
(2) To clarify that covered entities under section 340B may
contract with pharmacies to dispense on a covered entity's
behalf drugs purchased by a covered entity under section 340B
to generate savings to assist covered entities to stretch
resources to provide care to more patients and provide more
comprehensive services, and the requirements and prohibitions
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 FURNISHED 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
(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 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, including but not limited
to placing limits 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 compliance 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 conditions 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 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.''; and
(2) by adding at the end the following new paragraph:
``(11) Contract pharmacies.--The requirements 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 entity 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 subsection
(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 knowingly and
intentionally 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 violation;
``(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 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) 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 permit covered entities to
assert claims of violations of subsection (a)(1) and
subsection (a)(11) under the process promulgated under
subparagraph (A).''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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