Florida Senate - 2024 SB 1608
By Senator Brodeur
10-01570A-24 20241608__
1 A bill to be entitled
2 An act relating to prohibitions related to 340B drugs;
3 creating s. 626.8829, F.S.; defining terms;
4 prohibiting certain actions by health insurance
5 issuers, pharmacy benefit managers, or other third
6 party payors, or their agents, relating to
7 reimbursement to a 340B entity for 340B drugs;
8 providing applicability; prohibiting certain actions
9 by manufacturers relating to interference with the
10 acquisition of a 340B drug; prohibiting a
11 manufacturer’s interference with a pharmacy’s right to
12 contract with a 340B entity; providing that each
13 commission of certain acts constitutes a violation of
14 the Florida Deceptive and Unfair Trade Practices Act
15 and subjects the violator to certain actions and
16 penalties; providing that each commission of a
17 prohibited act constitutes a violation of the Florida
18 Deceptive and Unfair Trade Practices Act; providing an
19 effective date.
20
21 Be It Enacted by the Legislature of the State of Florida:
22
23 Section 1. Section 626.8829, Florida Statutes, is created
24 to read:
25 626.8829 Prohibitions related to 304B drugs.—
26 (1) As used in this subsection, the terms:
27 (a) “340B drug” means a drug that has been subject to any
28 offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
29 s. 256b and is purchased by a covered entity as defined in 42
30 U.S.C. s. 256b(a)(4).
31 (b) “340B entity” means an entity participating or
32 authorized to participate in the federal 340B Drug Discount
33 Program, as described in 42 U.S.C. s. 256b, including its
34 pharmacy, or any pharmacy contracted with the participating
35 entity to dispense drugs purchased through the 340B Drug
36 Discount Program.
37 (c) “Health insurance issuer” means an entity subject to
38 the insurance laws and regulations of this state, or subject to
39 the jurisdiction of the commissioner, which contracts or offers
40 to contract, or enters into an agreement to provide, deliver,
41 arrange for, pay for, or reimburse any of the costs of health
42 care services, including a sickness and accident insurance
43 company, a health maintenance organization, a preferred provider
44 organization or any similar entity, or any other entity
45 providing a plan of health insurance or health benefits.
46 (d) “Manufacturer” means any person that is a manufacturer
47 of a prescription drug and that manufactures or distributes such
48 prescription drug in this state.
49 (e) “Pharmacy” has the same meaning as in s. 465.003.
50 (f) “Pharmacy benefit manager” has the same meaning as in
51 s. 626.88.
52 (2) With respect to reimbursement to a 340B entity for 340B
53 drugs, a health insurance issuer, pharmacy benefit manager, or
54 other third-party payor, or their agents, may not do any of the
55 following:
56 (a) Reimburse a 340B entity for 340B drugs at a rate lower
57 than that paid for the same drug to non-340B entities or
58 entities owned or operated by the pharmacy benefit manager or
59 lower reimbursement for a claim on the basis that the claim is
60 for a 340B drug.
61 (b) Impose any terms or conditions on any 340B entity which
62 differ from such terms or conditions applied to non-340B
63 entities on the basis that the entity participates in the
64 federal 340B Drug Discount Program set forth in 42 U.S.C. s.
65 256b or that a drug is a 340B drug, including, but not limited
66 to, any of the following terms or conditions related to:
67 1. Fees, charges, clawbacks, or other adjustments or
68 assessments. For purposes of this subsection, the term “other
69 adjustments” includes, but is not limited to, placing any
70 additional requirements, restrictions, or unnecessary burdens on
71 the 340B entity which result in administrative costs or fees to
72 the 340B entity which are not placed on non-340B entities,
73 including affiliate pharmacies of the health insurance issuer,
74 pharmacy benefit manager, or other third-party payor.
75 2. Dispensation of fees that are less than such fees for
76 non-340B entities.
77 3. Restrictions or requirements regarding participation in
78 standard or preferred pharmacy networks.
79 4. Requirements relating to the frequency or scope of
80 audits of inventory management systems.
81 5. Requirements that a claim for a drug include any
82 identification, billing modifier, attestation, or other
83 indication that a drug is a 340B drug in order to be processed
84 or resubmitted unless it is required by the Centers for Medicare
85 and Medicaid Services or the Agency for Health Care
86 Administration for the administration of the Florida Medicaid
87 program.
88 6. Any other restrictions, conditions, practices, or
89 policies that are not imposed on non-340B entities.
90 (c) Require a 340B entity to reverse, resubmit, or clarify
91 a claim after the initial adjudication unless these actions are
92 in the normal course of pharmacy business and not related to
93 340B drug pricing.
94 (d) Base an action or contract requirement solely on the
95 basis that the entity is a participant in the 340B drug discount
96 program in such a manner that prevents or interferes with any
97 patient's choice to receive such drugs from the 340B entity or
98 its contracted pharmacy, including the creation of a restriction
99 or additional charge on a patient who chooses to receive drugs
100 from a 340B entity through direct dispensing, delivery, mail
101 order, or administration of such drugs, regardless of the type
102 of insurance coverage or medication. For purposes of this
103 paragraph, it is considered a prohibited practice that prevents
104 or interferes with a patient’s choice to receive drugs at a 340B
105 entity if a health insurance issuer, pharmacy benefit manager,
106 or other third-party payor places any additional requirements,
107 restrictions, or unnecessary burdens on the 340B entity beyond
108 that of any other pharmacy dispensing medications within the
109 scope of Florida law, including, but not limited to, requiring a
110 claim for a drug to include any identification, billing
111 modifier, attestation, or other indication that a drug is a 340B
112 drug in order to be processed or resubmitted unless it is
113 required by the Centers for Medicare and Medicaid Services or
114 the Agency for Health Care Administration in administration of
115 the Florida Medicaid program.
116 (e) Require or compel the submission of ingredient costs or
117 pricing data pertaining to 340B drugs to any health insurance
118 issuer, pharmacy benefit manager, or other third-party payor.
119 (f) Exclude any 340B entity from the health insurance
120 issuer, pharmacy benefit manager, or other third-party payor
121 network on the basis that the 340B entity dispenses drugs
122 subject to an agreement under 42 U.S.C. s. 256b, or refuse to
123 contract with a 340B entity for reasons other than those that
124 apply equally to non-340B entities.
125 (3) Subsection (2) does not apply to the Florida Medicaid
126 program as payor when Medicaid provides reimbursement for
127 covered outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
128 (4) A manufacturer may not deny, restrict, prohibit, or
129 otherwise interfere with, either directly or indirectly, the
130 acquisition of a 340B drug by, or delivery of a 340B drug to, a
131 pharmacy that is under contract with a 340B entity and is
132 authorized under such contract to receive and dispense 340B
133 drugs on behalf of the covered entity unless such receipt is
134 prohibited by the United States Department of Health and Human
135 Services.
136 (5) A manufacturer may not interfere with a pharmacy’s
137 right to contract with a 340B entity.
138 (6) The commission of any act prohibited by this section is
139 a deceptive and unfair trade practice, constitutes a violation
140 of the Florida Deceptive and Unfair Trade Practices Act under
141 part II of chapter 501, and subjects the violator to all
142 actions, including, but not limited to, investigative demands,
143 remedies, and penalties provided for in the Florida Deceptive
144 and Unfair Trade Practices Act. Each commission of a prohibited
145 act constitutes a violation of the Florida Deceptive and Unfair
146 Trade Practices Act.
147 Section 2. This act shall take effect July 1, 2024.