HLS 23RS-823 ORIGINAL
2023 Regular Session
HOUSE BILL NO. 548
BY REPRESENTATIVE TURNER
Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana.
DRUGS/PRESCRIPTION: Provides relative to the 340B drug pricing program
1 AN ACT
2To enact Chapter 36-A of Title 40 of the Louisiana Revised Statues of 1950, to be
3 comprised of R.S. 40:2881 through 2886, relative to the dispensation of certain
4 drugs by a healthcare facility; to provide for definitions; to identify certain actions
5 as discriminatory with respect to drugs discounted by a federal program and the
6 entities that dispense them; to provide for penalties; and to provide for related
7 matters.
8Be it enacted by the Legislature of Louisiana:
9 Section 1. Chapter 36-A of Title 40 of the Louisiana Revised Statues of 1950,
10comprised of R.S. 40:2881 through 2886, is hereby enacted to read as follows:
11 CHAPTER 36-A. DEFENDING AFFORDABLE PRESCRIPTION DRUG COSTS
12 §2881. Short title
13 This Chapter may be cited as the "Defending Affordable Prescription Drug
14 Costs Act".
15 §2882. Definitions
16 As used in this Chapter, the following terms have the following meanings:
17 (1) "340B drug" means a drug that has been subject to any offer for reduced
18 prices by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered
19 entity as defined in 42 U.S.C. 256b(a)(4).
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1 (2) "340B entity" means an entity participating or authorized to participate
2 in the federal 340B drug discount program, as described in 42 U.S.C. 256b, including
3 its pharmacy, or any pharmacy contracted with the participating entity to dispense
4 drugs purchased through the 340B drug discount program.
5 (3) "Health insurance issuer" has the same meaning as provided in R.S.
6 22:1019.1.
7 (4) "Manufacturer" has the same meaning as defined in R.S. 37:3462(12).
8 (5) "Pharmacy" has the same meaning as defined in R.S. 37:1164(38) except
9 that residents who are provided pharmacy provided care shall be physically located
10 in this state.
11 (6) "Pharmacy benefit manager" and "PBM" has the same meaning as
12 provided in R.S. 40:2863.
13 §2883. Prohibition of certain discriminatory actions related to reimbursement of
14 340B entities
15 A.(1) With respect to reimbursement to a 340B entity for 340B drugs, a
16 health insurance issuer, pharmacy benefit manager, other third-party payor, or its
17 agent shall not do any of the following:
18 (a) Reimburse a 340B entity for 340B drugs at a rate lower than that paid for
19 the same drug to entities that are not 340B entities or lower reimbursement for a
20 claim on the basis that the claim is for a 340B drug.
21 (b) Impose any terms or conditions on any 340B entity with respect to any
22 of the following that differ from such terms or conditions applied to non-340B
23 entities on the basis that the entity participates in the federal 340B drug discount
24 program set forth in 42 U.S.C. 256b or that a drug is a 340B drug including, without
25 limitation, any of the following:
26 (i) Fees, charges, clawbacks, or other adjustments or assessments. For
27 purposes of this Subsection, the term "other adjustment" includes placing any
28 additional requirements, restrictions, or unnecessary burdens upon the 340B entity
29 that results in administrative costs or fees to the 340B entity that are not placed upon
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1 other entities that do not participate in the 340B drug discount program, including
2 affiliate pharmacies of the health insurance issuer, pharmacy benefit manager, or
3 other third-party payor.
4 (ii) Dispensing fees that are less than the dispensing fees for non-340B
5 entities.
6 (iii) Restrictions or requirements regarding participation in standard or
7 preferred pharmacy networks.
8 (iv) Requirements relating to the frequency or scope of audits of inventory
9 management systems.
10 (v) Requirements that a claim for a drug include any identification, billing
11 modifier, attestation, or other indication that a drug is a 340B drug in order to be
12 processed or resubmitted unless it is required by the Centers for Medicare and
13 Medicaid Services or the Louisiana Department of Health for the administration of
14 the Louisiana Medicaid program.
15 (vi) Any other restrictions, conditions, practices, or policies that are not
16 imposed on non-340B entities.
17 (c) Require a 340B entity to reverse, resubmit, or clarify a claim after the
18 initial adjudication unless these actions are in the normal course of pharmacy
19 business and not related to 340B drug pricing.
20 (d) Discriminate against a 340B entity in a manner that prevents or interferes
21 with any patient's choice to receive such drugs from the 340B entity, including the
22 administration of such drugs. For purposes of this Subsection, it is considered a
23 discriminatory practice that prevents or interferes with a patient's choice to receive
24 drugs at a 340B entity if a health insurance issuer, pharmacy benefit manager, or
25 other third-party payor places any additional requirements, restrictions, or
26 unnecessary burdens upon the 340B entity that results in administrative costs or fees
27 to the 340B entity, including but not limited to requiring a claim for a drug to include
28 any identification, billing modifier, attestation or other indication that a drug is a
29 340B drug in order to be processed or resubmitted unless it is required by the Centers
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HB NO. 548
1 for Medicare and Medicaid Services or the Louisiana Department of Health in
2 administration of the Louisiana Medicaid program.
3 (e) Include any other provision in a contract between a health insurance
4 issuer, pharmacy benefit manager, or other third-party payor and a 340B entity that
5 discriminates against the 340B entity or prevents or interferes with an individual's
6 choice to receive a prescription drug from a 340B entity, including the administration
7 of the drug, in person or via direct delivery, mail, or other form of shipment, or
8 creation of a restriction or additional charge on a patient who chooses to receive
9 drugs from a 340B entity.
10 (f) Require or compel the submission of ingredient costs or pricing data
11 pertaining to 340B drugs to any health insurance issuer, pharmacy benefit manager,
12 or other third-party payor.
13 (g) Exclude any 340B entity from the health insurance issuer, pharmacy
14 benefit manager, or other third-party payor network on the basis that the 340B entity
15 dispenses drugs subject to an agreement under 42 U.S.C. 256b, or refusing to
16 contract with a 340B entity for reasons other than those that apply equally to
17 non-340B entities.
18 B. Nothing in this Chapter applies to the Louisiana Medicaid program as
19 payor when Medicaid provides reimbursement for covered outpatient drugs as
20 defined in 42 U.S.C. 1396r-8(k)).
21 §2884. Prohibition of certain discriminatory actions by a manufacturer or distributor
22 related to 340B entities
23 A. A manufacturer or distributor shall not deny, restrict, prohibit, or
24 otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug
25 by, or delivery of a 340B drug to, a pharmacy that is under contract with a 340B
26 entity and is authorized under such contract to receive and dispense 340B drugs on
27 behalf of the covered entity unless such receipt is prohibited by the United States
28 Department of Health and Human Services.
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1 B. A manufacturer or distributor shall not interfere with a pharmacy
2 contracted with a 340B entity.
3 §2885. Violations
4 A. The commission of any act prohibited by this Chapter is considered a
5 violation of the Unfair Trade Practices and Consumer Protection Law, provided for
6 in R.S. 51:1401 et seq and subjects the violator to any and all actions, including
7 investigative demands, private actions, remedies, and penalties provided for in the
8 Unfair Trade Practices and Consumer Protection Law. A violation occurs each time
9 a prohibited act is committed.
10 B. A violation of this Chapter authorizes any aggrieved person or entity to
11 bring an action pursuant to R.S. 51:1409.
12 §2886. Federal preemption
13 A. Nothing in this Chapter is to be construed or applied to be less restrictive
14 than federal law for a person or entity regulated by this Chapter.
15 B. Nothing in this Chapter is to be construed or applied to be in conflict with
16 any of the following:
17 (1) Applicable federal law and related regulations.
18 (2) Other laws of this state if the state law is compatible with applicable
19 federal law.
20 C. Limited distribution of a drug required under 21 U.S.C. 355-1 is not to be
21 construed as a violation of this Chapter.
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no part
of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute
part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)]
HB 548 Original 2023 Regular Session Turner
Abstract: Prohibits discriminatory practices that directly or indirectly limit the monetary
benefit that entities participating in the federal 340B Drug Pricing Program receive
as result of dispensing drugs discounted by the program.
Proposed law creates the "Defending Affordable Prescription Drug Costs" Act.
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Proposed law provides for definitions for certain terms including "340B drug" and "340B
entity".
Proposed law prohibits practices by a health insurance issuer, pharmacy benefit manger, or
other third-party payor that would limit or impose conditions that would indirectly lower the
amount of reimbursement for a drug discounted according to the federal 340B drug pricing
program that was dispensed by an entity participating in the 340B drug pricing program.
Proposed law prohibits actions by a manufacturer or distributor that would deny, restrict,
prohibit, or otherwise interfere with the acquisition of a 340B discounted drug to a pharmacy
that is under contract with a healthcare facility that participates in the 340B drug discount
program.
Proposed law provides that the commission of any act prohibited by proposed law
constitutes a violation Unfair Trade Practices and Consumer Protection Law and an
aggrieved party may bring an action under present law.
Proposed law provides that nothing in proposed law will be less restrictive than or construed
to conflict with federal law.
(Adds R.S. 40:2881-2886)
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