Read the full stored bill text
Florida Senate
-
2026
SB 1638
By
Senator Jones
34-00322-26 20261638__
1 A bill to be entitled
2 An act relating to prohibitions against discriminatory
3 practices relating to 340B entities and 340B drugs;
4 providing a short title; creating s. 499.061, F.S.;
5 providing definitions; prohibiting drug manufacturers
6 from engaging in certain acts relating to the
7 acquisition of 340B drugs by and the delivery of such
8 drugs to specified pharmacies; providing an exception;
9 prohibiting drug manufacturers from interfering with
10 pharmacies’ rights to contract with 340B entities;
11 providing that each commission of certain acts
12 constitutes a violation of the Florida Deceptive and
13 Unfair Trade Practices Act and subjects the violator
14 to certain actions and penalties; providing
15 construction and applicability; creating s. 626.8829,
16 F.S.; providing definitions; prohibiting health
17 insurance issuers, pharmacy benefit managers, and
18 other third-party payors, and agents thereof, from
19 engaging in certain discriminatory acts relating to
20 reimbursement to 340B entities for 340B drugs;
21 providing applicability; providing that each
22 commission of certain acts constitutes a violation of
23 the Florida Deceptive and Unfair Trade Practices Act
24 and subjects the violator to certain actions and
25 penalties; providing construction; creating ss.
26 627.64743, 627.65733, and 641.31543, F.S.; providing
27 definitions; prohibiting individual health insurers,
28 group, blanket, and franchise health insurers, and
29 health maintenance organizations, respectively, and
30 pharmacy benefit managers on behalf of such insurers
31 and health maintenance organizations, from engaging in
32 certain discriminatory acts relating to reimbursement
33 to 340B entities for 340B drugs; providing
34 applicability; providing that each commission of
35 certain acts constitutes a violation of the Florida
36 Deceptive and Unfair Trade Practices Act and subjects
37 the violator to certain actions and penalties;
38 providing construction; providing an effective date.
39
40 Be It Enacted by the Legislature of the State of Florida:
41
42 Section 1.
This act may be cited as the “Defending
43
Affordable Prescription Drug Costs Act.”
44 Section 2. Section 499.061, Florida Statutes, is created to
45 read:
46
499.061
Prohibitions against manufacturers’ discriminatory
47
practices relating to 340B drugs and 340B entities.—
48
(1)
As used in this section, the term:
49
(a)
“340B drug” means a drug that has been subject to any
50
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
51
s. 256b and is purchased by a covered entity as defined in 42
52
U.S.C. s. 256b(a)(4).
53
(b)
“340B entity” means an entity participating or
54
authorized to participate in the 340B Drug Pricing Program, as
55
described in 42 U.S.C. s. 256b, including its pharmacy, or any
56
pharmacy contracted with the participating entity to dispense
57
drugs purchased through the 340B Drug Pricing Program.
58
(2)
A manufacturer may not:
59
(a)
Deny, restrict, prohibit, or otherwise interfere with,
60
directly or indirectly, the acquisition of a 340B drug by, or
61
delivery of a 340B drug to, a pharmacy that is under contract
62
with a 340B entity and is authorized under such contract to
63
receive and dispense 340B drugs on behalf of the covered entity
64
unless such receipt is prohibited by the United States
65
Department of Health and Human Services; or
66
(b)
Interfere with a pharmacy’s right to contract with a
67
340B entity.
68
(3)
The commission of any act prohibited by this section is
69
a deceptive and unfair trade practice and constitutes a
70
violation of the Florida Deceptive and Unfair Trade Practices
71
Act under part II of chapter 501, and subjects the violator to
72
all actions, including, but not limited to, investigative
73
demands, remedies, and penalties, provided for in the Florida
74
Deceptive and Unfair Trade Practices Act.
75
(4)
This section may not be construed to be less
76
restrictive than federal law for a person or entity to which
77
this section applies. This section may not be construed to be in
78
conflict with any of the following:
79
(a)
Applicable federal law or regulations.
80
(b)
Other laws of this state which are compatible with
81
applicable federal law.
82
(5)
Limited distribution of a drug that is subject to a
83
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
84
is not a violation of this section.
85 Section 3. Section 626.8829, Florida Statutes, is created
86 to read:
87
626.8829
Reimbursement to 340B entities for 340B drugs.—
88
(1)
As used in this section, the term:
89
(a)
“340B drug” means a drug that has been subject to any
90
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
91
s. 256b and is purchased by a covered entity as defined in 42
92
U.S.C. s. 256b(a)(4).
93
(b)
“340B entity” means an entity participating or
94
authorized to participate in the 340B Drug Pricing Program, as
95
described in 42 U.S.C. s. 256b, including its pharmacy, or any
96
pharmacy contracted with the participating entity to dispense
97
drugs purchased through the 340B Drug Pricing Program.
98
(c)
“Health insurance issuer” means an entity subject to
99
the insurance laws and regulations of this state, or subject to
100
the jurisdiction of the Commissioner of Insurance Regulation,
101
which contracts, offers to contract, or enters into an agreement
102
to provide, deliver, arrange for, pay for, or reimburse any of
103
the costs of health care services. The term includes an accident
104
and sickness insurance company, a health maintenance
105
organization, a preferred provider organization or any similar
106
entity, or any other entity providing a plan of health insurance
107
or health benefits.
108
(d)
“Pharmacy” has the same meaning as in s. 465.003.
109
(2)
With respect to reimbursement to a 340B entity for a
110
340B drug, a health insurance issuer, pharmacy benefit manager,
111
or other third-party payor, or its agents, may not do any of the
112
following:
113
(a)
Reimburse the 340B entity for the 340B drug at a rate
114
lower than that paid for the same drug to non-340B entities or
115
to entities owned or operated by the pharmacy benefit manager on
116
the basis that the claim is for a 340B drug.
117
(b)
Impose any terms or conditions on the 340B entity which
118
differ from such terms or conditions applied to non-340B
119
entities on the basis that the entity participates in the 340B
120
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that the
121
drug is a 340B drug, including, but not limited to, any of the
122
following terms or conditions:
123
1.
Fees, charges, clawbacks, or other adjustments or
124
assessments. As used in this subparagraph, the term “other
125
adjustments” includes, but is not limited to, placing any
126
additional requirements, restrictions, or unnecessary burdens on
127
the 340B entity which result in administrative costs or fees to
128
the 340B entity and which are not placed on non-340B entities,
129
including affiliate pharmacies of the health insurance issuer,
130
pharmacy benefit manager, or other third-party payor.
131
2.
Dispensing fees that are less than dispensing fees for
132
non-340B entities.
133
3.
Restrictions or requirements regarding participation in
134
standard or preferred pharmacy networks.
135
4.
Requirements relating to the frequency or scope of
136
audits of inventory management systems.
137
5.
Requirements that a claim for a drug include any
138
identification, billing modifier, attestation, or other
139
indication that a drug is a 340B drug in order to be processed
140
or resubmitted unless it is required by the Centers for Medicare
141
and Medicaid Services or the Agency for Health Care
142
Administration for the administration of the Medicaid program.
143
6.
Any other restrictions, conditions, practices, or
144
policies that are not imposed on non-340B entities.
145
(c)
Require the 340B entity to reverse, resubmit, or
146
clarify a claim after the initial adjudication unless such
147
actions are in the normal course of pharmacy business and not
148
related to 340B drug pricing.
149
(d)
Base an action or contract requirement solely on the
150
basis that the entity is a participant in the 340B Drug Pricing
151
Program in such a manner that prevents or interferes with any
152
patient’s choice to receive such drugs from the 340B entity or
153
its contracted pharmacy, including the creation of a restriction
154
or additional charge on a patient who chooses to receive drugs
155
from a 340B entity or its contracted pharmacy through direct
156
dispensing, delivery, mail order, or administration of such
157
drugs, regardless of the type of insurance coverage or
158
medication. For purposes of this paragraph, it is considered a
159
prohibited practice that prevents or interferes with a patient’s
160
choice to receive drugs from a 340B entity or its contracted
161
pharmacy if a health insurance issuer, pharmacy benefit manager,
162
or other third-party payor places any additional requirements,
163
restrictions, or unnecessary burdens on the 340B entity or its
164
contracted pharmacy beyond that of any other pharmacy dispensing
165
medications within the scope of general law, including, but not
166
limited to, requiring a claim for a drug to include any
167
identification, billing modifier, attestation, or other
168
indication that a drug is a 340B drug in order to be processed
169
or resubmitted, unless it is required by the Centers for
170
Medicare and Medicaid Services or the Agency for Health Care
171
Administration in administration of the Medicaid program.
172
(e)
Require or compel the submission of ingredient costs or
173
pricing data pertaining to 340B drugs to any health insurance
174
issuer, pharmacy benefit manager, or other third-party payor.
175
(f)
Exclude the 340B entity from the network of the health
176
insurance issuer, pharmacy benefit manager, or other third-party
177
payor on the basis that the 340B entity dispenses drugs subject
178
to an agreement under 42 U.S.C. s. 256b, or refuse to contract
179
with the 340B entity for reasons other than those that apply
180
equally to non-340B entities.
181
(3)
Subsection (2) does not apply to the Medicaid program
182
as payor when Medicaid provides reimbursement for covered
183
outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
184
(4)
The commission of any act prohibited by this section is
185
a deceptive and unfair trade practice, constitutes a violation
186
of the Florida Deceptive and Unfair Trade Practices Act under
187
part II of chapter 501, and subjects the violator to all
188
actions, including, but not limited to, investigative demands,
189
remedies, and penalties, provided for in the Florida Deceptive
190
and Unfair Trade Practices Act.
191
(5)
This section may not be construed to be less
192
restrictive than federal law for a person or entity to which
193
this section applies. This section may not be construed to be in
194
conflict with any of the following:
195
(a)
Applicable federal law or regulations.
196
(b)
Other laws of this state that are compatible with
197
applicable federal law.
198
(6)
Limited distribution of a drug that is subject to a
199
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
200
is not a violation of this section.
201 Section 4. Section 627.64743, Florida Statutes, is created
202 to read:
203
627.64743
Reimbursement to 340B entities for 340B drugs.—
204
(1)
As used in this section, the term:
205
(a)
“340B drug” means a drug that has been subject to any
206
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
207
s. 256b and is purchased by a covered entity as defined in 42
208
U.S.C. s. 256b(a)(4).
209
(b)
“340B entity” means an entity participating or
210
authorized to participate in the 340B Drug Pricing Program, as
211
described in 42 U.S.C. s. 256b, including its pharmacy, or any
212
pharmacy contracted with the participating entity to dispense
213
drugs purchased through the 340B Drug Pricing Program.
214
(c)
“Pharmacy” has the same meaning as in s. 465.003.
215
(d)
“Pharmacy benefit manager” has the same meaning as in
216
s. 627.64741(1).
217
(2)
With respect to reimbursement to a 340B entity for a
218
340B drug, an insurer issuing, delivering, or renewing an
219
individual health insurance policy in this state which provides
220
prescription drug coverage, or a pharmacy benefit manager on
221
behalf of such insurer, may not do any of the following:
222
(a)
Reimburse the 340B entity for the 340B drug at a rate
223
lower than that paid for the same drug to non-340B entities on
224
the basis that the claim is for a 340B drug.
225
(b)
Impose any terms or conditions on the 340B entity which
226
differ from such terms or conditions applied to non-340B
227
entities on the basis that the entity participates in the 340B
228
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that the
229
drug is a 340B drug, including, but not limited to, any of the
230
following terms or conditions:
231
1.
Fees, charges, clawbacks, or other adjustments or
232
assessments. As used in this subparagraph, the term “other
233
adjustments” includes, but is not limited to, placing any
234
additional requirements, restrictions, or unnecessary burdens on
235
the 340B entity which result in administrative costs or fees to
236
the 340B entity
and
which are not placed on non-340B entities,
237
including affiliate pharmacies or in-network pharmacies of the
238
insurer or of the pharmacy benefit manager.
239
2.
Dispensing fees that are less than dispensing fees for
240
non-340B entities.
241
3.
Restrictions or requirements regarding participation in
242
standard or preferred pharmacy networks.
243
4.
Requirements relating to the frequency or scope of
244
audits of inventory management systems.
245
5.
Requirements that a claim for a drug include any
246
identification, billing modifier, attestation, or other
247
indication that a drug is a 340B drug in order to be processed
248
or resubmitted unless it is required by the Centers for Medicare
249
and Medicaid Services or the Agency for Health Care
250
Administration for the administration of the Medicaid program.
251
6.
Any other restrictions, conditions, practices, or
252
policies that are not imposed on non-340B entities.
253
(c)
Require the 340B entity to reverse, resubmit, or
254
clarify a claim after the initial adjudication unless such
255
actions are in the normal course of pharmacy business and not
256
related to 340B drug pricing.
257
(d)
Base an action or a contract requirement solely on the
258
basis that the entity is a participant in the 340B Drug Pricing
259
Program in such a manner that prevents or interferes with a
260
patient’s choice to receive such drugs from the 340B entity or
261
its contracted pharmacy, including the creation of a restriction
262
or an additional charge on a patient who chooses to receive
263
drugs from a 340B entity or its contracted pharmacy through
264
direct dispensing, delivery, mail order, or administration of
265
such drugs, regardless of the type of insurance coverage or
266
medication. For purposes of this paragraph, it is considered a
267
prohibited practice that prevents or interferes with a patient’s
268
choice to receive drugs from a 340B entity or its contracted
269
pharmacy if the insurer, or the pharmacy benefit manager on
270
behalf of the insurer, places any additional requirements,
271
restrictions, or unnecessary burdens on the 340B entity or its
272
contracted pharmacy beyond that of any other pharmacy dispensing
273
medications within the scope of general law, including, but not
274
limited to, requiring a claim for a drug to include any
275
identification, billing modifier, attestation, or other
276
indication that a drug is a 340B drug in order to be processed
277
or resubmitted, unless it is required by the Centers for
278
Medicare and Medicaid Services or the Agency for Health Care
279
Administration in administration of the Medicaid program.
280
(e)
Require or compel the submission of ingredient costs or
281
pricing data pertaining to 340B drugs to the insurer or the
282
pharmacy benefit manager.
283
(f)
Exclude the 340B entity from the network of the insurer
284
or pharmacy benefit manager on the basis that the 340B entity
285
dispenses drugs subject to an agreement under 42 U.S.C. s. 256b,
286
or refuse to contract with the 340B entity for reasons other
287
than those that apply equally to non-340B entities.
288
(3)
Subsection (2) does not apply to the Medicaid program
289
as payor when Medicaid provides reimbursement for covered
290
outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
291
(4)
The commission of any act prohibited by this section is
292
a deceptive and unfair trade practice, constitutes a violation
293
of the Florida Deceptive and Unfair Trade Practices Act under
294
part II of chapter 501, and subjects the violator to all
295
actions, including, but not limited to, investigative demands,
296
remedies, and penalties
,
provided for in the Florida Deceptive
297
and Unfair Trade Practices Act. Each commission of a prohibited
298
act constitutes a violation of the Florida Deceptive and Unfair
299
Trade Practices Act.
300
(5)
This section may not be construed to be less
301
restrictive than federal law for a person or entity to which
302
this section applies. This section may not be construed to be in
303
conflict with any of the following:
304
(a)
Applicable federal law or federal regulations.
305
(b)
Other laws of this state that are compatible with
306
applicable federal law.
307
(6)
Limited distribution of a drug that is subject to a
308
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
309
is not a violation of this section.
310 Section 5. Section 627.65733, Florida Statutes, is created
311 to read:
312
627.65733
Reimbursement to 340B entities for 340B drugs.—
313
(1)
As used in this section, the term:
314
(a)
“340B drug” means a drug that has been subject to any
315
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
316
s. 256b and is purchased by a covered entity as defined in 42
317
U.S.C. s. 256b(a)(4).
318
(b)
“340B entity” means an entity participating or
319
authorized to participate in the 340B Drug Pricing Program, as
320
described in 42 U.S.C. s. 256b, including its pharmacy, or any
321
pharmacy contracted with the participating entity to dispense
322
drugs purchased through the 340B Drug Pricing Program.
323
(c)
“Pharmacy” has the same meaning as in s. 465.003.
324
(d)
“Pharmacy benefit manager” has the same meaning as in
325
s. 627.6572(1).
326
(2)
With respect to reimbursement to a 340B entity for 340B
327
drugs, an insurer issuing, delivering, or renewing a group,
328
blanket, or franchise health insurance policy in this state
329
which provides prescription drug coverage, or a pharmacy benefit
330
manager on behalf of such insurer, may not do any of the
331
following:
332
(a)
Reimburse the 340B entity for 340B drugs at a rate
333
lower than that paid for the same drug to non-340B entities on
334
the basis that the claim is for a 340B drug.
335
(b)
Impose any terms or conditions on the 340B entity which
336
differ from such terms or conditions applied to non-340B
337
entities on the basis that the entity participates in the 340B
338
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that a
339
drug is a 340B drug, including, but not limited to, any of the
340
following terms or conditions:
341
1.
Fees, charges, clawbacks, or other adjustments or
342
assessments. As used in this subparagraph, the term “other
343
adjustments” includes, but is not limited to, placing any
344
additional requirements, restrictions, or unnecessary burdens on
345
the 340B entity which result in administrative costs or fees to
346
the 340B entity and which are not placed on non-340B entities,
347
including affiliate pharmacies or in-network pharmacies of the
348
insurer or of the pharmacy benefit manager.
349
2.
Dispensing fees that are less than dispensing fees for
350
non-340B entities.
351
3.
Restrictions or requirements regarding participation in
352
standard or preferred pharmacy networks.
353
4.
Requirements relating to the frequency or scope of
354
audits of inventory management systems.
355
5.
Requirements that a claim for a drug include any
356
identification, billing modifier, attestation, or other
357
indication that a drug is a 340B drug in order to be processed
358
or resubmitted unless it is required by the Centers for Medicare
359
and Medicaid Services or the Agency for Health Care
360
Administration for the administration of the Medicaid program.
361
6.
Any other restrictions, conditions, practices, or
362
policies that are not imposed on non-340B entities.
363
(c)
Require the 340B entity to reverse, resubmit, or
364
clarify a claim after the initial adjudication unless such
365
actions are in the normal course of pharmacy business and not
366
related to 340B drug pricing.
367
(d)
Base an action or contract requirement solely on the
368
basis that the entity is a participant in the 340B Drug Pricing
369
Program in such a manner that prevents or interferes with any
370
patient’s choice to receive such drugs from the 340B entity or
371
its contracted pharmacy, including the creation of a restriction
372
or additional charge on a patient who chooses to receive drugs
373
from a 340B entity or its contracted pharmacy through direct
374
dispensing, delivery, mail order, or administration of such
375
drugs, regardless of the type of insurance coverage or
376
medication. For purposes of this paragraph, it is considered a
377
prohibited practice that prevents or interferes with a patient’s
378
choice to receive drugs from a 340B entity or its contracted
379
pharmacy if the insurer, or the pharmacy benefit manager on
380
behalf of the insurer, places any additional requirements,
381
restrictions, or unnecessary burdens on the 340B entity beyond
382
that of any other pharmacy dispensing medications within the
383
scope of general law, including, but not limited to, requiring a
384
claim for a drug to include any identification, billing
385
modifier, attestation, or other indication that a drug is a 340B
386
drug in order to be processed or resubmitted, unless it is
387
required by the Centers for Medicare and Medicaid Services or
388
the Agency for Health Care Administration in administration of
389
the Medicaid program.
390
(e)
Require or compel the submission of ingredient costs or
391
pricing data pertaining to 340B drugs to the insurer or the
392
pharmacy benefit manager.
393
(f)
Exclude the 340B entity from the network of the insurer
394
or pharmacy benefit manager on the basis that the 340B entity
395
dispenses drugs subject to an agreement under 42 U.S.C. s. 256b,
396
or refuse to contract with the 340B entity for reasons other
397
than those that apply equally to non-340B entities.
398
(3)
Subsection (2) does not apply to the Medicaid program
399
as payor when Medicaid provides reimbursement for covered
400
outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
401
(4)
The commission of any act prohibited by this section is
402
a deceptive and unfair trade practice, constitutes a violation
403
of the Florida Deceptive and Unfair Trade Practices Act under
404
part II of chapter 501, and subjects the violator to all
405
actions, including, but not limited to, investigative demands,
406
remedies, and penalties, provided for in the Florida Deceptive
407
and Unfair Trade Practices Act. Each commission of a prohibited
408
act constitutes a violation of the Florida Deceptive and Unfair
409
Trade Practices Act.
410
(5)
This section may not be construed to be less
411
restrictive than federal law for a person or entity to which
412
this section applies. This section may not be construed to be in
413
conflict with any of the following:
414
(a)
Applicable federal law or regulations.
415
(b)
Other laws of this state that are compatible with
416
applicable federal law.
417
(6)
Limited distribution of a drug that is subject to a
418
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
419
is not a violation of this section.
420 Section 6. Section 641.31543, Florida Statutes, is created
421 to read:
422
641.31543
Reimbursement to 340B entities for 340B drugs.—
423
(1)
As used in this section, the term:
424
(a)
“340B drug” means a drug that has been subject to any
425
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
426
s. 256b and is purchased by a covered entity as defined in 42
427
U.S.C. s. 256b(a)(4).
428
(b)
“340B entity” means an entity participating or
429
authorized to participate in the 340B Drug Pricing Program, as
430
described in 42 U.S.C. s. 256b, including its pharmacy, or any
431
pharmacy contracted with the participating entity to dispense
432
drugs purchased through the 340B Drug Pricing Program.
433
(c)
“Pharmacy” has the same meaning as in s. 465.003.
434
(d)
“Pharmacy benefit manager” has the same meaning as in
435
s. 641.314(1).
436
(2)
With respect to reimbursement to a 340B entity for a
437
340B drug, a health maintenance organization issuing,
438
delivering, or renewing a health maintenance contract in this
439
state which provides prescription drug coverage, or a pharmacy
440
benefit manager on behalf of such health maintenance
441
organization, may not do any of the following:
442
(a)
Reimburse the 340B entity for the 340B drug at a rate
443
lower than that paid for the same drug to non-340B entities on
444
the basis that the claim is for a 340B drug.
445
(b)
Impose any terms or conditions on the 340B entity which
446
differ from such terms or conditions applied to non-340B
447
entities on the basis that the entity participates in the 340B
448
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that a
449
drug is a 340B drug, including, but not limited to, any of the
450
following terms or conditions:
451
1.
Fees, charges, clawbacks, or other adjustments or
452
assessments. For purposes of this subparagraph, the term “other
453
adjustments” includes, but is not limited to, placing any
454
additional requirements, restrictions, or unnecessary burdens on
455
the 340B entity which result in administrative costs or fees to
456
the 340B entity which are not placed on non-340B entities,
457
including affiliate pharmacies or in-network pharmacies of the
458
health maintenance organization or of the pharmacy benefit
459
manager.
460
2.
Dispensing of fees that are less than dispensing fees
461
for non-340B entities.
462
3.
Restrictions or requirements regarding participation in
463
standard or preferred pharmacy networks.
464
4.
Requirements relating to the frequency or scope of
465
audits of inventory management systems.
466
5.
Requirements that a claim for a drug include any
467
identification, billing modifier, attestation, or other
468
indication that a drug is a 340B drug in order to be processed
469
or resubmitted unless it is required by the Centers for Medicare
470
and Medicaid Services or the Agency for Health Care
471
Administration for the administration of the Medicaid program.
472
6.
Any other restrictions, conditions, practices, or
473
policies that are not imposed on non-340B entities.
474
(c)
Require the 340B entity to reverse, resubmit, or
475
clarify a claim after the initial adjudication unless such
476
actions are in the normal course of pharmacy business and not
477
related to 340B drug pricing.
478
(d)
Base an action or contract requirement solely on the
479
basis that the entity is a participant in the 340B Drug Pricing
480
Program in such a manner that prevents or interferes with any
481
patient’s choice to receive such drugs from the 340B entity or
482
its contracted pharmacy, including the creation of a restriction
483
or additional charge on a patient who chooses to receive drugs
484
from a 340B entity or its contracted pharmacy through direct
485
dispensing, delivery, mail order, or administration of such
486
drugs, regardless of the type of insurance coverage or
487
medication. For purposes of this paragraph, it is considered a
488
prohibited practice that prevents or interferes with a patient’s
489
choice to receive drugs from a 340B entity or its contracted
490
pharmacy if the health maintenance organization, or the pharmacy
491
benefit manager on behalf of the health maintenance
492
organization, places any additional requirements, restrictions,
493
or unnecessary burdens on the 340B entity or its contracted
494
pharmacy beyond that of any other pharmacy dispensing
495
medications within the scope of general law, including, but not
496
limited to, requiring a claim for a drug to include any
497
identification, billing modifier, attestation, or other
498
indication that a drug is a 340B drug in order to be processed
499
or resubmitted, unless it is required by the Centers for
500
Medicare and Medicaid Services or the Agency for Health Care
501
Administration in administration of the Medicaid program.
502
(e)
Require or compel the submission of ingredient costs or
503
pricing data pertaining to 340B drugs to the health maintenance
504
organization or the pharmacy benefit manager.
505
(f)
Exclude the 340B entity from the network of the health
506
maintenance organization or pharmacy benefit manager on the
507
basis that the 340B entity dispenses drugs subject to an
508
agreement under 42 U.S.C. s. 256b, or refuse to contract with
509
the 340B entity for reasons other than those that apply equally
510
to non-340B entities.
511
(3)
Subsection (2) does not apply to the Medicaid program
512
as payor when Medicaid provides reimbursement for covered
513
outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
514
(4)
The commission of any act prohibited by this section is
515
a deceptive and unfair trade practice, constitutes a violation
516
of the Florida Deceptive and Unfair Trade Practices Act under
517
part II of chapter 501, and subjects the violator to all
518
actions, including, but not limited to, investigative demands,
519
remedies, and penalties, provided for in the Florida Deceptive
520
and Unfair Trade Practices Act. Each commission of a prohibited
521
act constitutes a violation of the Florida Deceptive and Unfair
522
Trade Practices Act.
523
(5)
This section may not be construed to be less
524
restrictive than federal law for a person or entity to which
525
this section applies. This section may not be construed to be in
526
conflict with any of the following:
527
(a)
Applicable federal law or regulations.
528
(b)
Other laws of this state that are compatible with
529
applicable federal law.
530
(6)
Limited distribution of a drug that is subject to a
531
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
532
is not a violation of this section.
533 Section 7. This act shall take effect July 1, 2026.