THE BILL ITSELF
HB 1281
Prohibitions Against Discriminatory Practices relating to 340B Entities and 340B Drugs
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 against the acquisitions
7
of 340B drugs by and the delivery of such drugs to
8
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 these 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.
40
Be It Enacted by the Legislature of the State of Florida:
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
45
to 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 terms:
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
69
is 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. Each commission of a
75
prohibited act constitutes a violation of the Florida Deceptive
76
and Unfair Trade Practices Act.
77
(4) This section may not be construed to be less
78
restrictive than federal law for a person or entity to which
79
this section applies. This section may not be construed to be in
80
conflict with any of the following:
81
(a) Applicable federal law or regulations.
82
(b) Other laws of this state which are compatible with
83
applicable federal law.
84
(5) Limited distribution of a drug that is subject to a
85
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
86
is not a violation of this section.
87
Section 3. Section 626.8829, Florida Statutes, is created
88
to read:
89
626.8829 Reimbursement to 304B entities for 340B drugs.—
90
(1) As used in this section, the term:
91
(a) "340B drug" means a drug that has been subject to any
92
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
93
s. 256b and is purchased by a covered entity as defined in 42
94
U.S.C. s. 256b(a)(4).
95
(b) "340B entity" means an entity participating or
96
authorized to participate in the 340B Drug Pricing Program, as
97
described in 42 U.S.C. s. 256b, including its pharmacy, or any
98
pharmacy contracted with the participating entity to dispense
99
drugs purchased through the 340B Drug Pricing Program.
100
(c) "Health insurance issuer" means an entity subject to
101
the insurance laws and regulations of this state, or subject to
102
the jurisdiction of the Commissioner of Insurance Regulation,
103
which contracts, offers to contract, or enters into an agreement
104
to provide, deliver, arrange for, pay for, or reimburse any of
105
the costs of health care services. The term includes an accident
106
and sickness insurance company, a health maintenance
107
organization, a preferred provider organization or any similar
108
entity, or any other entity providing a plan of health insurance
109
or health benefits.
110
(d) "Pharmacy" has the same meaning as in s. 465.003.
111
(2) With respect to reimbursement to a 340B entity for a
112
340B drug, a health insurance issuer, pharmacy benefit manager,
113
or other third-party payor, or their agents, may not do any of
114
the following:
115
(a) Reimburse the 340B entity for the 340B drug at a rate
116
lower than that paid for the same drug to non-340B entities or
117
to entities owned or operated by the pharmacy benefit manager on
118
the basis that the claim is for a 340B drug.
119
(b) Impose any terms or conditions on the 340B entity
120
which differ from such terms or conditions applied to non-340B
121
entities on the basis that the entity participates in the 340B
122
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that the
123
drug is a 340B drug, including, but not limited to, any of the
124
following terms or conditions relating to:
125
1. Fees, charges, clawbacks, or other adjustments or
126
assessments. As used in this subparagraph, the term "other
127
adjustments" includes, but is not limited to, placing any
128
additional requirements, restrictions, or unnecessary burdens on
129
the 340B entity which result in administrative costs or fees to
130
the 340B entity which are not placed on non-340B entities,
131
including affiliate pharmacies of the health insurance issuer,
132
pharmacy benefit manager, or other third-party payor.
133
2. Dispensing fees that are less than dispensing fees for
134
non-340B entities.
135
3. Restrictions or requirements regarding participation in
136
standard or preferred pharmacy networks.
137
4. Requirements relating to the frequency or scope of
138
audits of inventory management systems.
139
5. Requirements that a claim for a drug include any
140
identification, billing modifier, attestation, or other
141
indication that a drug is a 340B drug in order to be processed
142
or resubmitted unless it is required by the Centers for Medicare
143
and Medicaid Services or the Agency for Health Care
144
Administration for the administration of the Medicaid program.
145
6. Any other restrictions, conditions, practices, or
146
policies that are not imposed on non-340B entities.
147
(c) Require the 340B entity to reverse, resubmit, or
148
clarify a claim after the initial adjudication unless such
149
actions are in the normal course of pharmacy business and not
150
related to 340B drug pricing.
151
(d) Base an action or contract requirement solely on the
152
basis that the entity is a participant in the 340B Drug Pricing
153
Program in such a manner that prevents or interferes with any
154
patient's choice to receive such drugs from the 340B entity or
155
its contracted pharmacy, including the creation of a restriction
156
or additional charge on a patient who chooses to receive drugs
157
from a 340B entity or its contracted pharmacy through direct
158
dispensing, delivery, mail order, or administration of such
159
drugs, regardless of the type of insurance coverage or
160
medication. For purposes of this paragraph, it is considered a
161
prohibited practice that prevents or interferes with a patient's
162
choice to receive drugs from a 340B entity or its contracted
163
pharmacy if a health insurance issuer, pharmacy benefit manager,
164
or other third-party payor places any additional requirements,
165
restrictions, or unnecessary burdens on the 340B entity or its
166
contracted pharmacy beyond that of any other pharmacy dispensing
167
medications within the scope of general law, including, but not
168
limited to, requiring a claim for a drug to include any
169
identification, billing modifier, attestation, or other
170
indication that a drug is a 340B drug in order to be processed
171
or resubmitted, unless it is required by the Centers for
172
Medicare and Medicaid Services or the Agency for Health Care
173
Administration in administration of the Medicaid program.
174
(e) Require or compel the submission of ingredient costs
175
or pricing data pertaining to 340B drugs to any health insurance
176
issuer, pharmacy benefit manager, or other third-party payor.
177
(f) Exclude the 340B entity from the network of the health
178
insurance issuer, pharmacy benefit manager, or other third-party
179
payor on the basis that the 340B entity dispenses drugs subject
180
to an agreement under 42 U.S.C. s. 256b, or refuse to contract
181
with the 340B entity for reasons other than those that apply
182
equally to non-340B entities.
183
(3) Subsection (2) does not apply to the Medicaid program
184
as payor when Medicaid provides reimbursement for covered
185
outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
186
(4) The commission of any act prohibited by this section
187
is a deceptive and unfair trade practice, constitutes a
188
violation of the Florida Deceptive and Unfair Trade Practices
189
Act under part II of chapter 501, and subjects the violator to
190
all actions, including, but not limited to, investigative
191
demands, remedies, and penalties provided for in the Florida
192
Deceptive and Unfair Trade Practices Act. Each commission of a
193
prohibited act constitutes a violation of the Florida Deceptive
194
and Unfair Trade Practices Act.
195
(5) This section may not be construed to be less
196
restrictive than federal law for a person or entity to which
197
this section applies. This section may not be construed to be in
198
conflict with any of the following:
199
(a) Applicable federal law or regulations.
200
(b) Other laws of this state that are compatible with
201
applicable federal law.
202
(6) Limited distribution of a drug that is subject to a
203
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
204
is not a violation of this section. Section 4. Section 627.64743, Florida Statutes, is created
206
to read:
207
627.64743 Reimbursement to 340B entities for 340B drugs.—
208
(1) As used in this section, the term:
209
(a) "340B drug" means a drug that has been subject to any
210
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
211
s. 256b and is purchased by a covered entity as defined in 42
212
U.S.C. s. 256b(a)(4).
213
(b) "340B entity" means an entity participating or
214
authorized to participate in the 340B Drug Pricing Program, as
215
described in 42 U.S.C. s. 256b, including its pharmacy, or any
216
pharmacy contracted with the participating entity to dispense
217
drugs purchased through the 340B Drug Pricing Program.
218
(c) "Pharmacy" has the same meaning as in s. 465.003.
219
(d) "Pharmacy benefit manager" has the same meaning as in
220
s. 627.64741(1).
221
(2) With respect to reimbursement to a 340B entity for a
222
340B drug, an insurer issuing, delivering, or renewing an
223
individual health insurance policy in this state which provides
224
prescription drug coverage, or a pharmacy benefit manager on
225
behalf of such insurer, may not do any of the following:
226
(a) Reimburse the 340B entity for the 340B drug at a rate
227
lower than that paid for the same drug to non-340B entities on
228
the basis that the claim is for a 340B drug.
229
(b) Impose any terms or conditions on the 340B entity
230
which differ from such terms or conditions applied to non-340B
231
entities on the basis that the entity participates in the 340B
232
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that the
233
drug is a 340B drug, including, but not limited to, any of the
234
following terms or conditions relating to:
235
1. Fees, charges, clawbacks, or other adjustments or
236
assessments. As used in this subparagraph, the term "other
237
adjustments" includes, but is not limited to, placing any
238
additional requirements, restrictions, or unnecessary burdens on
239
the 340B entity which result in administrative costs or fees to
240
the 340B entity which are not placed on non-340B entities,
241
including affiliate pharmacies or in-network pharmacies of the
242
insurer or of the pharmacy benefit manager.
243
2. Dispensing fees that are less than dispensing fees for
244
non-340B entities.
245
3. Restrictions or requirements regarding participation in
246
standard or preferred pharmacy networks.
247
4. Requirements relating to the frequency or scope of
248
audits of inventory management systems.
249
5. Requirements that a claim for a drug include any
250
identification, billing modifier, attestation, or other
251
indication that a drug is a 340B drug in order to be processed
252
or resubmitted unless it is required by the Centers for Medicare
253
and Medicaid Services or the Agency for Health Care
254
Administration for the administration of the Medicaid program.
255
6. Any other restrictions, conditions, practices, or
256
policies that are not imposed on non-340B entities.
257
(c) Require the 340B entity to reverse, resubmit, or
258
clarify a claim after the initial adjudication unless such
259
actions are in the normal course of pharmacy business and not
260
related to 340B drug pricing.
261
(d) Base an action or a contract requirement solely on the
262
basis that the entity is a participant in the 340B Drug Pricing
263
Program in such a manner that prevents or interferes with a
264
patient's choice to receive such drugs from the 340B entity or
265
its contracted pharmacy, including the creation of a restriction
266
or an additional charge on a patient who chooses to receive
267
drugs from a 340B entity or its contracted pharmacy through
268
direct dispensing, delivery, mail order, or administration of
269
such drugs, regardless of the type of insurance coverage or
270
medication. For purposes of this paragraph, it is considered a
271
prohibited practice that prevents or interferes with a patient's
272
choice to receive drugs from a 340B entity or its contracted
273
pharmacy if the insurer, or the pharmacy benefit manager on
274
behalf of the insurer, places any additional requirements,
275
restrictions, or unnecessary burdens on the 340B entity or its
276
contracted pharmacy beyond that of any other pharmacy dispensing
277
medications within the scope of general law, including, but not
278
limited to, requiring a claim for a drug to include any
279
identification, billing modifier, attestation, or other
280
indication that a drug is a 340B drug in order to be processed
281
or resubmitted, unless it is required by the Centers for
282
Medicare and Medicaid Services or the Agency for Health Care
283
Administration in administration of the Medicaid program.
284
(e) Require or compel the submission of ingredient costs
285
or pricing data pertaining to 340B drugs to the insurer or the
286
pharmacy benefit manager.
287
(f) Exclude the 340B entity from the network of the
288
insurer or pharmacy benefit manager on the basis that the 340B
289
entity dispenses drugs subject to an agreement under 42 U.S.C.
290
s. 256b, or refuse to contract with the 340B entity for reasons
291
other than those that apply equally to non-340B entities.
292
(3) Subsection (2) does not apply to the Medicaid program
293
as payor when Medicaid provides reimbursement for covered
294
outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
295
(4) The commission of any act prohibited by this section
296
is a deceptive and unfair trade practice, constitutes a
297
violation of the Florida Deceptive and Unfair Trade Practices
298
Act under part II of chapter 501, and subjects the violator to
299
all actions, including, but not limited to, investigative
300
demands, remedies, and penalties provided for in the Florida
301
Deceptive and Unfair Trade Practices Act. Each commission of a
302
prohibited act constitutes a violation of the Florida Deceptive
303
and Unfair Trade Practices Act.
304
(5) This section may not be construed to be less
305
restrictive than federal law for a person or entity to which
306
this section applies. This section may not be construed to be in
307
conflict with any of the following:
308
(a) Applicable federal law or federal regulations.
309
(b) Other laws of this state that are compatible with
310
applicable federal law.
311
(6) Limited distribution of a drug that is subject to a
312
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
313
is not a violation of this section.
314
Section 5. Section 627.65733, Florida Statutes, is created to read:
316
627.65733 Reimbursement to 340B entities for 340B drugs.—
317
(1) As used in this section, the term:
318
(a) "340B drug" means a drug that has been subject to any
319
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
320
s. 256b and is purchased by a covered entity as defined in 42
321
U.S.C. s. 256b(a)(4).
322
(b) "340B entity" means an entity participating or
323
authorized to participate in the 340B Drug Pricing Program, as
324
described in 42 U.S.C. s. 256b, including its pharmacy, or any
325
pharmacy contracted with the participating entity to dispense
326
drugs purchased through the 340B Drug Pricing Program.
327
(c) "Pharmacy" has the same meaning as in s. 465.003.
328
(d) "Pharmacy benefit manager" has the same meaning as in
329
s. 627.6572(1).
330
(2) With respect to reimbursement to a 340B entity for
331
340B drugs, an insurer issuing, delivering, or renewing a group,
332
blanket, or franchise health insurance policy in this state
333
which provides prescription drug coverage, or a pharmacy benefit
334
manager on behalf of such insurer, may not do any of the
335
following:
336
(a) Reimburse the 340B entity for 340B drugs at a rate
337
lower than that paid for the same drug to non-340B entities on
338
the basis that the claim is for a 340B drug.
339
(b) Impose any terms or conditions on the 340B entity
340
which differ from such terms or conditions applied to non-340B
341
entities on the basis that the entity participates in the 340B
342
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that a
343
drug is a 340B drug, including, but not limited to, any of the
344
following terms or conditions relating to:
345
1. Fees, charges, clawbacks, or other adjustments or
346
assessments. As used in this subparagraph, the term "other
347
adjustments" includes, but is not limited to, placing any
348
additional requirements, restrictions, or unnecessary burdens on
349
the 340B entity which result in administrative costs or fees to
350
the 340B entity which are not placed on non-340B entities,
351
including affiliate pharmacies or in-network pharmacies of the
352
insurer or of the pharmacy benefit manager.
353
2. Dispensing fees that are less than dispensing fees for
354
non-340B entities.
355
3. Restrictions or requirements regarding participation in
356
standard or preferred pharmacy networks.
357
4. Requirements relating to the frequency or scope of
358
audits of inventory management systems.
359
5. Requirements that a claim for a drug include any
360
identification, billing modifier, attestation, or other
361
indication that a drug is a 340B drug in order to be processed
362
or resubmitted unless it is required by the Centers for Medicare
363
and Medicaid Services or the Agency for Health Care
364
Administration for the administration of the Medicaid program.
365
6. Any other restrictions, conditions, practices, or
366
policies that are not imposed on non-340B entities.
367
(c) Require the 340B entity to reverse, resubmit, or
368
clarify a claim after the initial adjudication unless such
369
actions are in the normal course of pharmacy business and not
370
related to 340B drug pricing.
371
(d) Base an action or contract requirement solely on the
372
basis that the entity is a participant in the 340B Drug Pricing
373
Program in such a manner that prevents or interferes with any
374
patient's choice to receive such drugs from the 340B entity or
375
its contracted pharmacy, including the creation of a restriction
376
or additional charge on a patient who chooses to receive drugs
377
from a 340B entity or its contracted pharmacy through direct
378
dispensing, delivery, mail order, or administration of such
379
drugs, regardless of the type of insurance coverage or
380
medication. For purposes of this paragraph, it is considered a
381
prohibited practice that prevents or interferes with a patient's
382
choice to receive drugs from a 340B entity or its contracted
383
pharmacy if the insurer, or the pharmacy benefit manager on
384
behalf of the insurer, places any additional requirements,
385
restrictions, or unnecessary burdens on the 340B entity beyond
386
that of any other pharmacy dispensing medications within the
387
scope of general law, including, but not limited to, requiring a
388
claim for a drug to include any identification, billing
389
modifier, attestation, or other indication that a drug is a 340B
390
drug in order to be processed or resubmitted, unless it is
391
required by the Centers for Medicare and Medicaid Services or
392
the Agency for Health Care Administration in administration of
393
the Medicaid program.
394
(e) Require or compel the submission of ingredient costs
395
or pricing data pertaining to 340B drugs to the insurer or the
396
pharmacy benefit manager.
397
(f) Exclude the 340B entity from the network of the
398
insurer or pharmacy benefit manager on the basis that the 340B
399
entity dispenses drugs subject to an agreement under 42 U.S.C.
400
s. 256b, or refuse to contract with the 340B entity for reasons
401
other than those that apply equally to non-340B entities.
402
(3) Subsection (2) does not apply to the Medicaid program
403
as payor when Medicaid provides reimbursement for covered
404
outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
405
(4) The commission of any act prohibited by this section
406
is a deceptive and unfair trade practice, constitutes a
407
violation of the Florida Deceptive and Unfair Trade Practices
408
Act under part II of chapter 501, and subjects the violator to
409
all actions, including, but not limited to, investigative
410
demands, remedies, and penalties provided for in the Florida
411
Deceptive and Unfair Trade Practices Act. Each commission of a
412
prohibited act constitutes a violation of the Florida Deceptive
413
and Unfair Trade Practices Act.
414
(5) This section may not be construed to be less
415
restrictive than federal law for a person or entity to which
416
this section applies. This section may not be construed to be in
417
conflict with any of the following:
418
(a) Applicable federal law or regulations.
419
(b) Other laws of this state that are compatible with
420
applicable federal law.
421
(6) Limited distribution of a drug that is subject to a
422
risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
423
is not a violation of this section.
424
Section 6. Section 641.31543, Florida Statutes, is created
425
to read:
426
641.31543 Reimbursement to 340B entities for 340B drugs.—
427
(1) As used in this section, the term:
428
(a) "340B drug" means a drug that has been subject to any
429
offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
430
s. 256b and is purchased by a covered entity as defined in 42
431
U.S.C. s. 256b(a)(4).
432
(b) "340B entity" means an entity participating or
433
authorized to participate in the 340B Drug Pricing Program, as
434
described in 42 U.S.C. s. 256b, including its pharmacy, or any
435
pharmacy contracted with the participating entity to dispense
436
drugs purchased through the 340B Drug Pricing Program.
437
(c) "Pharmacy" has the same meaning as in s. 465.003.
438
(d) "Pharmacy benefit manager" has the same meaning as in
439
s. 641.314(1).
440
(2) With respect to reimbursement to a 340B entity for a
441
340B drug, a health maintenance organization issuing,
442
delivering, or renewing a health maintenance contract in this
443
state which provides prescription drug coverage, or a pharmacy
444
benefit manager on behalf of such health maintenance
445
organization, may not do any of the following:
446
(a) Reimburse the 340B entity for the 340B drug at a rate
447
lower than that paid for the same drug to non-340B entities on
448
the basis that the claim is for a 340B drug.
449
(b) Impose any terms or conditions on the 340B entity
450
which differ from such terms or conditions applied to non-340B
451
entities on the basis that the entity participates in the 340B
452
Drug Pricing Program set forth in 42 U.S.C. s. 256b or that a
453
drug is a 340B drug, including, but not limited to, any of the
454
following terms or conditions relating to:
455
1. Fees, charges, clawbacks, or other adjustments or
456
assessments. For purposes of this subparagraph, the term "other
457
adjustments" includes, but is not limited to, placing any
458
additional requirements, restrictions, or unnecessary burdens on
459
the 340B entity which result in administrative costs or fees to
460
the 340B entity which are not placed on non-340B entities,
461
including affiliate pharmacies or in-network pharmacies of the
462
health maintenance organization or of the pharmacy benefit
463
manager.
464
2. Dispensing of fees that are less than dispensing fees
465
for non-340B entities.
466
3. Restrictions or requirements regarding participation in
467
standard or preferred pharmacy networks.
468
4. Requirements relating to the frequency or scope of
469
audits of inventory management systems.
470
5. Requirements that a claim for a drug include any
471
identification, billing modifier, attestation, or other
472
indication that a drug is a 340B drug in order to be processed
473
or resubmitted unless it is required by the Centers for Medicare
474
and Medicaid Services or the Agency for Health Care
475
Administration for the administration of the Medicaid program.
476
6. Any other restrictions, conditions, practices, or
477
policies that are not imposed on non-340B entities.
478
(c) Require the 340B entity to reverse, resubmit, or
479
clarify a claim after the initial adjudication unless such
480
actions are in the normal course of pharmacy business and not
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related to 340B drug pricing.
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(d) Base an action or contract requirement solely on the
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basis that the entity is a participant in the 340B Drug Pricing
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Program in such a manner that prevents or interferes with any
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patient's choice to receive such drugs from the 340B entity or
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its contracted pharmacy, including the creation of a restriction
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or additional charge on a patient who chooses to receive drugs
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from a 340B entity or its contracted pharmacy through direct
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dispensing, delivery, mail order, or administration of such
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drugs, regardless of the type of insurance coverage or
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medication. For purposes of this paragraph, it is considered a
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prohibited practice that prevents or interferes with a patient's
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choice to receive drugs from a 340B entity or its contracted
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pharmacy if the health maintenance organization, or the pharmacy
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benefit manager on behalf of the health maintenance
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organization, places any additional requirements, restrictions,
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or unnecessary burdens on the 340B entity or its contracted
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pharmacy beyond that of any other pharmacy dispensing
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medications within the scope of general law, including, but not
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limited to, requiring a claim for a drug to include any
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identification, billing modifier, attestation, or other
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indication that a drug is a 340B drug in order to be processed
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or resubmitted, unless it is required by the Centers for
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Medicare and Medicaid Services or the Agency for Health Care
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Administration in administration of the Medicaid program.
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(e) Require or compel the submission of ingredient costs
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or pricing data pertaining to 340B drugs to the health
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maintenance organization or the pharmacy benefit manager.
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(f) Exclude the 340B entity from the network of the health
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maintenance organization or pharmacy benefit manager on the
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basis that the 340B entity dispenses drugs subject to an
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agreement under 42 U.S.C. s. 256b, or refuse to contract with
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the 340B entity for reasons other than those that apply equally
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to non-340B entities.
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(3) Subsection (2) does not apply to the Medicaid program
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as payor when Medicaid provides reimbursement for covered
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outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
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(4) The commission of any act prohibited by this section
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is a deceptive and unfair trade practice, constitutes a
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violation of the Florida Deceptive and Unfair Trade Practices
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Act under part II of chapter 501, and subjects the violator to
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all actions, including, but not limited to, investigative
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demands, remedies, and penalties provided for in the Florida
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Deceptive and Unfair Trade Practices Act. Each commission of a
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prohibited act constitutes a violation of the Florida Deceptive
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and Unfair Trade Practices Act.
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(5) This section may not be construed to be less
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restrictive than federal law for a person or entity to which
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this section applies. This section may not be construed to be in
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conflict with any of the following:
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(a) Applicable federal law or regulations.
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(b) Other laws of this state that are compatible with
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applicable federal law.
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(6) Limited distribution of a drug that is subject to a
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risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
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is not a violation of this section.
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Section 7. This act shall take effect July 1, 2026.