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As Amended by Senate Committee
Session of 2025
SENATE BILL No. 284
By Committee on Federal and State Affairs
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AN ACT concerning prescription drugs; relating to the federal 340B drug
pricing program; enacting the defense of drug delivery act to prohibit
manufacturer interference relating to 340B drug distribution.
Be it enacted by the Legislature of the State of Kansas:
Section 1. Sections 1 through 9, and amendments thereto, shall be
known and may be cited as the defense of drug delivery act.
Sec. 2. As used in this act:
(a) "340B drug" means a drug that:
(1) Is a covered outpatient drug within the federal 340B drug pricing
program authorized by 42 U.S.C. § 256b;
(2) has been subject to any offer for reduced prices by a manufacturer
under 42 U.S.C. § 256b(a)(1); and
(3) is purchased by a covered entity. A drug shall be considered
purchased if such drug would have been purchased except for the
restriction or limitation described in section 3, and amendments thereto.
(b) "Attorney general" means the attorney general of the state of
Kansas or the attorney general's designee.
(c) "Biological product" means the same as defined in 42 U.S.C. §
262(i), as in effect on January 1, 2025.
(d) "Board" means the state board of pharmacy created by K.S.A. 74-
1603, and amendments thereto.
(e) "Covered entity" means the same as defined in 42 U.S.C. §
256b(a)(4), as in effect on January 1, 2025.
(f) "Distribute" or "distribution" means the same as defined in K.S.A.
65-1626, and amendments thereto.
(g) "Federal healthcare program" means any plan or program that
provides health benefits, whether directly, through insurance or otherwise,
that is funded directly, in whole or in part, by the United States
government or any state health care program as defined in 42 U.S.C. §
1320a-7(h), as in effect on January 1, 2025.
(h) "Health information" means any information, including
demographic information collected from an individual or a group of
individuals, that:
(1) Is created or received by a healthcare provider, pharmacy, health
plan, employer or healthcare clearinghouse; and
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SB 284—Am. by SC 2
(2) relates to the past, present or future physical or mental health or
condition of an individual, the provision of healthcare to an individual or
the past, present or future payment for the provision of healthcare to an
individual.
(i) "Manufacturer" means the same as defined in K.S.A. 65-1626, and
amendments thereto.
(j) "Package" means the smallest individual saleable unit of product
for distribution by a manufacturer or repackager that is intended by the
manufacturer for ultimate sale to the dispenser of such product.
(k) "Repackager" means the same as defined in K.S.A. 65-1626, and
amendments thereto.
(l) "Third-party logistics provider" means the same as defined in
K.S.A. 65-1626, and amendments thereto.
(m) "Virtual wholesale distributor" means the same as defined in
K.S.A. 65-1626, and amendments thereto.
(n) "Wholesale distributor" means the same as defined in K.S.A. 65-
1626, and amendments thereto.
Sec. 3. (a) A manufacturer, wholesaler, virtual wholesaler, third party
logistics provider or repackager or an agent, contractor or affiliate thereof,
including an entity that collects or processes health information, shall not,
directly or indirectly, deny, restrict, prohibit, discriminate against or
otherwise limit the acquisition or delivery of a 340B drug to a covered
entity or a location otherwise authorized by a covered entity to receive a
340B drug unless such receipt is prohibited by the United States
department of health and human services or applicable state law.
(b) A manufacturer shall not directly or indirectly require, including
as a condition, a covered entity or a location authorized by a covered entity
to receive 340B drugs, to submit any health information, claims or
utilization data, purchasing, payment or other data, unless such
information or data is voluntarily furnished by such covered entity or
otherwise required to be furnished under applicable federal or state law.
Sec. 4. (a) The attorney general may adopt rules and regulations as
necessary to implement and administer the provisions of this act.
(b) There is hereby established in the state treasury the defense of
drug delivery fund to be administered by the attorney general. All moneys
received by the attorney general from fines or penalties collected under the
provisions of this act shall be remitted to the state treasurer in accordance
with the provisions of K.S.A. 75-4215, and amendments thereto. The state
treasurer shall deposit the entire amount thereof in the state treasury to the
credit of the defense of drug delivery fund. All expenditures from such
fund shall be made in accordance with appropriation acts upon warrants of
the director of accounts and reports issued pursuant to vouchers approved
by the attorney general or the attorney general's designee. All moneys
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credited to the defense of drug delivery fund shall be expended for the
administration of the duties, functions and operating expenses incurred
under the provisions of this act.
Sec. 5. (a) If, by the attorney general's own inquiries or as a result of
complaints, the attorney general has reason to believe that a person or
entity has violated the provisions of section 3, and amendments thereto,
the attorney general or assistant attorney general may administer oaths and
affirmations, subpoena witnesses or matter and collect evidence. The
board may assist the attorney general in any investigation related to a
suspected violation of section 3, and amendments thereto.
(b) The attorney general, upon a finding that a person or entity has
violated the provisions of section 3, and amendments thereto, may impose
a civil penalty upon such person or entity.
(c) A person or entity who violates the provisions of section 3, and
amendments thereto, in addition to any other penalty provided by law, may
incur a civil penalty in an amount of not to exceed $50,000 for each
violation.
(d) A civil penalty shall not be imposed pursuant to this section
except upon the written order of the attorney general to the person or entity
who is responsible for the violation. Such order is a final order for
purposes of judicial review and shall state the violation, the penalty to be
imposed, and the right of such person or entity to appeal as provided in the
Kansas judicial review act.
(e) Each package of 340B drugs found to be subject to a violation
under section 3, and amendments thereto, shall constitute a separate
violation of this act.
Sec. 6. The board may investigate any complaint of a violation of
section 3, and amendments thereto, by a person or entity subject to
registration or permitting requirements of the board and upon , including
any wholesaler that may possess evidence supporting such complaint.
Upon a finding of a violation, the board may impose discipline,
suspension or revocation of the registration or permit of any such person
or entity.
Sec. 7. (a) Limited distribution of a drug required under 21 U.S.C. §
355-1 shall not be construed as a violation of this act.
(b) Section 3, and amendments thereto, shall not be construed as
prohibiting a manufacturer from requiring health information or other data
that a covered entity is required to furnish to the manufacturer under
applicable state and federal law, including data related to an audit in
accordance with procedures established by the United States department of
health and human services under 42 U.S.C. § 256b (a)(5)(C).
Sec. 8. Nothing in this act shall be construed or applied to be less
restrictive than any federal law as to any person or entity referenced in or
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regulated by this act. Nothing in this act shall be construed or applied to be
in conflict with applicable federal law and related regulation or other laws
of this state that are compatible with applicable federal law.
Sec. 9. The provisions of this act are severable. If any provision of
the act is declared unconstitutional or invalid, or the application of any
portion of the act to any person or circumstance is held unconstitutional or
invalid, the invalidity shall not affect other portions of the act that can be
given effect without the invalid portion or application, and the
applicability of such other portions of the act to any person or
circumstance shall remain valid and enforceable.
Sec. 10. This act shall take effect and be in force from and after its
publication in the statute book.
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