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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
A bill to be entitled 1
An act relating to prohibitions against discriminatory 2
practices relating to 340B entities and 340B drugs; 3
creating s. 499.0263, F.S.; providing definitions; 4
prohibiting drug manufacturers from engaging in 5
certain acts against the acquisitions of 340B drug s by 6
and the delivery of such drugs to specified 7
pharmacies; providing an exception; prohibiting drug 8
manufacturers from interfering with pharmacies' rights 9
to contract with 340B entities; providing that each 10
commission of certain acts constitutes a violat ion of 11
the Florida Deceptive and Unfair Trade Practices Act 12
and subjects the violator to certain actions and 13
penalties; creating s. 626.8829, F.S.; defining terms; 14
prohibiting certain acts by health insurance issuers, 15
pharmacy benefit managers, or other th ird-party 16
payors, or their agents, relating to reimbursement to 17
a 340B entity for 340B drugs; providing applicability; 18
prohibiting certain acts by manufacturers relating to 19
interference with the acquisition of a 340B drug; 20
prohibiting a manufacturer's inte rference with a 21
pharmacy's right to contract with a 340B entity; 22
providing that each commission of certain acts 23
constitutes a violation of the Florida Deceptive and 24
Unfair Trade Practices Act and subjects the violator 25
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
to certain actions and penalties; crea ting ss. 26
627.64743, 627.65733, and 641.31543, F.S.; defining 27
terms; prohibiting individual health insurers, group, 28
blanket, and franchise health insurers, and health 29
maintenance organizations, respectively, and pharmacy 30
benefit managers on behalf of these insurers and 31
health maintenance organizations, from engaging in 32
certain acts against 340B entities for 340B drugs; 33
providing applicability; providing that each 34
commission of certain acts constitutes a violation of 35
the Florida Deceptive and Unfair Trade Pra ctices Act 36
and subjects the violator to certain actions and 37
penalties; providing an effective date. 38
39
Be It Enacted by the Legislature of the State of Florida: 40
41
Section 1. Section 499.0263, Florida Statutes, is created 42
to read: 43
499.0263 Prohibitions against manufacturers' 44
discriminatory practices relating to 340B entities and 340B 45
drugs.— 46
(1) As used in this section, the term: 47
(a) "340B drug" means a drug that has been subject to any 48
offer for reduced prices by a manufacturer pursuant to 42 U .S.C. 49
s. 256b and is purchased by a covered entity as defined in 42 50
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
U.S.C. s. 256b(a)(4). 51
(b) "340B entity" means an entity participating or 52
authorized to participate in the 340B Drug Discount Program, as 53
described in 42 U.S.C. s. 256b, including its pha rmacy, or any 54
pharmacy contracted with the participating entity to dispense 55
drugs purchased through the 340B Drug Discount Program. 56
(2) A manufacturer may not: 57
(a) Deny, restrict, prohibit, or otherwise interfere with, 58
directly or indirectly, the acqui sition of a 340B drug by, or 59
the delivery of a 340B drug to, a pharmacy that is under 60
contract with a 340B entity and is authorized under such 61
contract to receive and dispense 340B drugs on behalf of the 62
covered entity unless such receipt is prohibited by the United 63
States Department of Health and Human Services. 64
(b) Interfere with a pharmacy's right to contract with a 65
340B entity. 66
(3) The commission of any act prohibited by this section 67
is a deceptive and unfair trade practice, constitutes a 68
violation of the Florida Deceptive and Unfair Trade Practices 69
Act under part II of chapter 501, and subjects the violator to 70
all actions, including, but not limited to, investigative 71
demands, remedies, and penalties provided for in the Florida 72
Deceptive and Unfair T rade Practices Act. Each commission of a 73
prohibited act constitutes a violation of the Florida Deceptive 74
and Unfair Trade Practices Act. 75
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
Section 2. Section 626.8829, Florida Statutes, is created 76
to read: 77
626.8829 Prohibitions relating to 304B entitie s and 78
drugs.— 79
(1) As used in this section, the term: 80
(a) "340B drug" means a drug that has been subject to any 81
offer for reduced prices by a manufacturer pursuant to 42 U.S.C. 82
s. 256b and is purchased by a covered entity as defined in 42 83
U.S.C. s. 256b(a)(4). 84
(b) "340B entity" means an entity participating or 85
authorized to participate in the 340B Drug Discount Program, as 86
described in 42 U.S.C. s. 256b, including its pharmacy, or any 87
pharmacy contracted with the participating entity to dispense 88
drugs purchased through the 340B Drug Discount Program. 89
(c) "Health insurance issuer" means an entity subject to 90
the insurance laws and regulations of this state, or subject to 91
the jurisdiction of the commissioner, which contracts, offers to 92
contract, or enters into an agreement to provide, deliver, 93
arrange for, pay for, or reimburse any of the costs of health 94
care services. The term includes a sickness and accident 95
insurance company, a health maintenance organization, a 96
preferred provider organization or any s imilar entity, or any 97
other entity providing a plan of health insurance or health 98
benefits. 99
(d) "Manufacturer" means any person that is a manufacturer 100
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
of a prescription drug and that manufactures or distributes such 101
prescription drug in this state. 102
(e) "Pharmacy" has the same meaning as in s. 465.003. 103
(f) "Pharmacy benefit manager" has the same meaning as in 104
s. 626.88. 105
(2) With respect to reimbursement to a 340B entity for 106
340B drugs, a health insurance issuer, pharmacy benefit manager, 107
or other third-party payor, or their agents, may not do any of 108
the following: 109
(a) Reimburse the 340B entity for 340B drugs at a rate 110
lower than that paid for the same drug to non -340B entities or 111
entities owned or operated by the pharmacy benefit manager on 112
the basis that the claim is for a 340B drug. 113
(b) Impose any terms or conditions on the 340B entity 114
which differ from such terms or conditions applied to non -340B 115
entities on the basis that the entity participates in the 340B 116
Drug Discount Program set forth in 42 U.S.C. s. 256b or that a 117
drug is a 340B drug, including, but not limited to, any of the 118
following terms or conditions relating to: 119
1. Fees, charges, clawbacks, or other adjustments or 120
assessments. For purposes of this subparagraph, the term "other 121
adjustments" includes, but is not limited to, placing any 122
additional requirements, restrictions, or unnecessary burdens on 123
the 340B entity which result in administrative costs or fees to 124
the 340B entity which are not placed on non -340B entities, 125
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
including affiliate pharmacies of the health insurance issuer, 126
pharmacy benefit manager, or other third -party payor. 127
2. Dispensation of fees that are less than such fees for 128
non-340B entities. 129
3. Restrictions or requirements regarding participation in 130
standard or preferred pharmacy networks. 131
4. Requirements relating to the frequency or scope of 132
audits of inventory management systems. 133
5. Requirements that a claim for a drug include any 134
identification, billing modifier, attestation, or other 135
indication that a drug i s a 340B drug in order to be processed 136
or resubmitted unless it is required by the Centers for Medicare 137
and Medicaid Services or the Agency for Health Care 138
Administration for the administration of the Medicaid program. 139
6. Any other restrictions, conditio ns, practices, or 140
policies that are not imposed on non -340B entities. 141
(c) Require the 340B entity to reverse, resubmit, or 142
clarify a claim after the initial adjudication unless these 143
actions are in the normal course of pharmacy business and not 144
related to 340B drug pricing. 145
(d) Base an action or contract requirement solely on the 146
basis that the entity is a participant in the 340B Drug Discount 147
Program in such a manner that prevents or interferes with any 148
patient's choice to receive such drugs from the 3 40B entity, 149
including the creation of a restriction or additional charge on 150
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
a patient who chooses to receive drugs from a 340B entity 151
through direct dispensing, delivery, mail order, or 152
administration of such drugs, regardless of the type of 153
insurance coverage or medication. For purposes of this 154
paragraph, it is considered a prohibited practice that prevents 155
or interferes with a patient's choice to receive drugs at a 340B 156
entity if a health insurance issuer, pharmacy benefit manager, 157
or other third-party payor places any additional requirements, 158
restrictions, or unnecessary burdens on the 340B entity beyond 159
that of any other pharmacy dispensing medications within the 160
scope of Florida law, including, but not limited to, requiring a 161
claim for a drug to include any identification, billing 162
modifier, attestation, or other indication that a drug is a 340B 163
drug in order to be processed or resubmitted, unless it is 164
required by the Centers for Medicare and Medicaid Services or 165
the Agency for Health Care Administration in administration of 166
the Medicaid program. 167
(e) Require or compel the submission of ingredient costs 168
or pricing data pertaining to 340B drugs to any health insurance 169
issuer, pharmacy benefit manager, or other third -party payor. 170
(f) Exclude the 340B ent ity from the health insurance 171
issuer, pharmacy benefit manager, or other third -party payor 172
network on the basis that the 340B entity dispenses drugs 173
subject to an agreement under 42 U.S.C. s. 256b, or refuse to 174
contract with the 340B entity for reasons oth er than those that 175
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
apply equally to non -340B entities. 176
(3) Subsection (2) does not apply to the Medicaid program 177
as payor when Medicaid provides reimbursement for covered 178
outpatient drugs as defined in 42 U.S.C. s. 1396r -8(k). 179
(4) A manufacturer may no t deny, restrict, prohibit, or 180
otherwise interfere with, directly or indirectly, the 181
acquisition of a 340B drug by, or the delivery of a 340B drug 182
to, a pharmacy that is under contract with a 340B entity and is 183
authorized under such contract to receive and dispense 340B 184
drugs on behalf of the covered entity unless such receipt is 185
prohibited by the United States Department of Health and Human 186
Services. 187
(5) A manufacturer may not interfere with a pharmacy's 188
right to contract with a 340B entity. 189
(6) The commission of any act prohibited by this section 190
is a deceptive and unfair trade practice, constitutes a 191
violation of the Florida Deceptive and Unfair Trade Practices 192
Act under part II of chapter 501, and subjects the violator to 193
all actions, including, but not limited to, investigative 194
demands, remedies, and penalties provided for in the Florida 195
Deceptive and Unfair Trade Practices Act. Each commission of a 196
prohibited act constitutes a violation of the Florida Deceptive 197
and Unfair Trade Practices Act. 198
Section 3. Section 627.64743, Florida Statutes, is created 199
to read: 200
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
627.64743 Reimbursement of 340B entities for 340B drugs. — 201
(1) As used in this section, the term: 202
(a) "340B drug" means a drug that has been subject to any 203
offer for reduced prices by a manufacturer pursuant to 42 U.S.C. 204
s. 256b and is purchased by a covered entity as defined in 42 205
U.S.C. s. 256b(a)(4). 206
(b) "340B entity" means an entity participating or 207
authorized to participate in the 340B Drug Discount Program, as 208
described in 42 U.S.C. s. 256b, including its pharmacy, or any 209
pharmacy contracted with the participating entity to dispense 210
drugs purchased through the 340B Drug Discount Program. 211
(c) "Pharmacy" has the same meaning as in s. 465.003. 212
(d) "Pharmacy benefit manager" has t he same meaning as in 213
s. 627.64741(1). 214
(2) With respect to reimbursement to a 340B entity for 215
340B drugs, an insurer issuing, delivering, or renewing an 216
individual health insurance policy in this state which provides 217
prescription drug coverage, or a pharmacy benefit manager on 218
behalf of such insurer, may not do any of the following: 219
(a) Reimburse the 340B entity for 340B drugs at a rate 220
lower than that paid for the same drug to non -340B entities on 221
the basis that the claim is for a 340B drug. 222
(b) Impose any terms or conditions on the 340B entity 223
which differ from such terms or conditions applied to non -340B 224
entities on the basis that the entity participates in the 340B 225
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
Drug Discount Program set forth in 42 U.S.C. s. 256b or that a 226
drug is a 340B drug, including, but not limited to, any of the 227
following terms or conditions relating to: 228
1. Fees, charges, clawbacks, or other adjustments or 229
assessments. For purposes of this subparagraph, the term "other 230
adjustments" includes, but is not limited to, pl acing any 231
additional requirements, restrictions, or unnecessary burdens on 232
the 340B entity which result in administrative costs or fees to 233
the 340B entity which are not placed on non -340B entities, 234
including affiliate pharmacies or in -network pharmacies of the 235
insurer or of the pharmacy benefit manager. 236
2. Dispensation of fees that are less than such fees for 237
non-340B entities. 238
3. Restrictions or requirements regarding participation in 239
standard or preferred pharmacy networks. 240
4. Requirements relating to the frequency or scope of 241
audits of inventory management systems. 242
5. Requirements that a claim for a drug include any 243
identification, billing modifier, attestation, or other 244
indication that a drug is a 340B drug in order to be processed 245
or resubmitted unless it is required by the Centers for Medicare 246
and Medicaid Services or the Agency for Health Care 247
Administration for the administration of the Medicaid program. 248
6. Any other restrictions, conditions, practices, or 249
policies that are not imposed on no n-340B entities. 250
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(c) Require the 340B entity to reverse, resubmit, or 251
clarify a claim after the initial adjudication unless these 252
actions are in the normal course of pharmacy business and not 253
related to 340B drug pricing. 254
(d) Base an action or contract requirement solely on the 255
basis that the entity is a participant in the 340B Drug Discount 256
Program in such a manner that prevents or interferes with any 257
patient's choice to receive such drugs from the 340B entity, 258
including the creation of a restriction o r additional charge on 259
a patient who chooses to receive drugs from a 340B entity 260
through direct dispensing, delivery, mail order, or 261
administration of such drugs, regardless of the type of 262
insurance coverage or medication. For purposes of this 263
paragraph, it is considered a prohibited practice that prevents 264
or interferes with a patient's choice to receive drugs at a 340B 265
entity if the insurer, or the pharmacy benefit manager on behalf 266
of the insurer, places any additional requirements, 267
restrictions, or unnec essary burdens on the 340B entity beyond 268
that of any other pharmacy dispensing medications within the 269
scope of Florida law, including, but not limited to, requiring a 270
claim for a drug to include any identification, billing 271
modifier, attestation, or other i ndication that a drug is a 340B 272
drug in order to be processed or resubmitted, unless it is 273
required by the Centers for Medicare and Medicaid Services or 274
the Agency for Health Care Administration in administration of 275
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
the Medicaid program. 276
(e) Require or compel the submission of ingredient costs 277
or pricing data pertaining to 340B drugs to the insurer or the 278
pharmacy benefit manager. 279
(f) Exclude the 340B entity from the network of the 280
insurer or pharmacy benefit manager on the basis that the 340B 281
entity dispenses drugs subject to an agreement under 42 U.S.C. 282
s. 256b, or refuse to contract with the 340B entity for reasons 283
other than those that apply equally to non -340B entities. 284
(3) Subsection (2) does not apply to the Medicaid program 285
as payor when Medica id provides reimbursement for covered 286
outpatient drugs as defined in 42 U.S.C. s. 1396r -8(k). 287
(4) The commission of any act prohibited by this section 288
is a deceptive and unfair trade practice, constitutes a 289
violation of the Florida Deceptive and Unfair T rade Practices 290
Act under part II of chapter 501, and subjects the violator to 291
all actions, including, but not limited to, investigative 292
demands, remedies, and penalties provided for in the Florida 293
Deceptive and Unfair Trade Practices Act. Each commission o f a 294
prohibited act constitutes a violation of the Florida Deceptive 295
and Unfair Trade Practices Act. 296
Section 4. Section 627.65733, Florida Statutes, is created 297
to read: 298
627.65733 Reimbursement of 340B entities for 340B drugs. — 299
(1) As used in this se ction, the term: 300
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(a) "340B drug" means a drug that has been subject to any 301
offer for reduced prices by a manufacturer pursuant to 42 U.S.C. 302
s. 256b and is purchased by a covered entity as defined in 42 303
U.S.C. s. 256b(a)(4). 304
(b) "340B entity" means an e ntity participating or 305
authorized to participate in the 340B Drug Discount Program, as 306
described in 42 U.S.C. s. 256b, including its pharmacy, or any 307
pharmacy contracted with the participating entity to dispense 308
drugs purchased through the 340B Drug Discou nt Program. 309
(c) "Pharmacy" has the same meaning as in s. 465.003. 310
(d) "Pharmacy benefit manager" has the same meaning as in 311
s. 627.6572(1). 312
(2) With respect to reimbursement to a 340B entity for 313
340B drugs, an insurer issuing, delivering, or renewing a group, 314
blanket, or franchise health insurance policy in this state 315
which provides prescription drug coverage, or a pharmacy benefit 316
manager on behalf of such insurer, may not do any of the 317
following: 318
(a) Reimburse the 340B entity for 340B drugs at a r ate 319
lower than that paid for the same drug to non -340B entities on 320
the basis that the claim is for a 340B drug. 321
(b) Impose any terms or conditions on the 340B entity 322
which differ from such terms or conditions applied to non -340B 323
entities on the basis tha t the entity participates in the 340B 324
Drug Discount Program set forth in 42 U.S.C. s. 256b or that a 325
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
drug is a 340B drug, including, but not limited to, any of the 326
following terms or conditions relating to: 327
1. Fees, charges, clawbacks, or other adjustmen ts or 328
assessments. For purposes of this subparagraph, the term "other 329
adjustments" includes, but is not limited to, placing any 330
additional requirements, restrictions, or unnecessary burdens on 331
the 340B entity which result in administrative costs or fees to 332
the 340B entity which are not placed on non -340B entities, 333
including affiliate pharmacies or in -network pharmacies of the 334
insurer or of the pharmacy benefit manager. 335
2. Dispensation of fees that are less than such fees for 336
non-340B entities. 337
3. Restrictions or requirements regarding participation in 338
standard or preferred pharmacy networks. 339
4. Requirements relating to the frequency or scope of 340
audits of inventory management systems. 341
5. Requirements that a claim for a drug include any 342
identification, billing modifier, attestation, or other 343
indication that a drug is a 340B drug in order to be processed 344
or resubmitted unless it is required by the Centers for Medicare 345
and Medicaid Services or the Agency for Health Care 346
Administration for the administrati on of the Medicaid program. 347
6. Any other restrictions, conditions, practices, or 348
policies that are not imposed on non -340B entities. 349
(c) Require the 340B entity to reverse, resubmit, or 350
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
clarify a claim after the initial adjudication unless these 351
actions are in the normal course of pharmacy business and not 352
related to 340B drug pricing. 353
(d) Base an action or contract requirement solely on the 354
basis that the entity is a participant in the 340B Drug Discount 355
Program in such a manner that prevents or inte rferes with any 356
patient's choice to receive such drugs from the 340B entity, 357
including the creation of a restriction or additional charge on 358
a patient who chooses to receive drugs from a 340B entity 359
through direct dispensing, delivery, mail order, or 360
administration of such drugs, regardless of the type of 361
insurance coverage or medication. For purposes of this 362
paragraph, it is considered a prohibited practice that prevents 363
or interferes with a patient's choice to receive drugs at a 340B 364
entity if the insurer , or the pharmacy benefit manager on behalf 365
of the insurer, places any additional requirements, 366
restrictions, or unnecessary burdens on the 340B entity beyond 367
that of any other pharmacy dispensing medications within the 368
scope of Florida law, including, but not limited to, requiring a 369
claim for a drug to include any identification, billing 370
modifier, attestation, or other indication that a drug is a 340B 371
drug in order to be processed or resubmitted, unless it is 372
required by the Centers for Medicare and Medica id Services or 373
the Agency for Health Care Administration in administration of 374
the Medicaid program. 375
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(e) Require or compel the submission of ingredient costs 376
or pricing data pertaining to 340B drugs to the insurer or the 377
pharmacy benefit manager. 378
(f) Exclude the 340B entity from the network of the 379
insurer or pharmacy benefit manager on the basis that the 340B 380
entity dispenses drugs subject to an agreement under 42 U.S.C. 381
s. 256b, or refuse to contract with the 340B entity for reasons 382
other than those tha t apply equally to non -340B entities. 383
(3) Subsection (2) does not apply to the Medicaid program 384
as payor when Medicaid provides reimbursement for covered 385
outpatient drugs as defined in 42 U.S.C. s. 1396r -8(k). 386
(4) The commission of any act prohibited b y this section 387
is a deceptive and unfair trade practice, constitutes a 388
violation of the Florida Deceptive and Unfair Trade Practices 389
Act under part II of chapter 501, and subjects the violator to 390
all actions, including, but not limited to, investigative 391
demands, remedies, and penalties provided for in the Florida 392
Deceptive and Unfair Trade Practices Act. Each commission of a 393
prohibited act constitutes a violation of the Florida Deceptive 394
and Unfair Trade Practices Act. 395
Section 5. Section 641.31543, Flor ida Statutes, is created 396
to read: 397
641.31543 Reimbursement of 340B entities for 340B drugs. — 398
(1) As used in this section, the term: 399
(a) "340B drug" means a drug that has been subject to any 400
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
offer for reduced prices by a manufacturer pursuant to 42 U.S.C. 401
s. 256b and is purchased by a covered entity as defined in 42 402
U.S.C. s. 256b(a)(4). 403
(b) "340B entity" means an entity participating or 404
authorized to participate in the 340B Drug Discount Program, as 405
described in 42 U.S.C. s. 256b, including its ph armacy, or any 406
pharmacy contracted with the participating entity to dispense 407
drugs purchased through the 340B Drug Discount Program. 408
(c) "Pharmacy" has the same meaning as in s. 465.003. 409
(d) "Pharmacy benefit manager" has the same meaning as in 410
s. 641.314(1). 411
(2) With respect to reimbursement to a 340B entity for 412
340B drugs, a health maintenance organization issuing, 413
delivering, or renewing a health maintenance contract in this 414
state which provides prescription drug coverage, or a pharmacy 415
benefit manager on behalf of such health maintenance 416
organization, may not do any of the following: 417
(a) Reimburse the 340B entity for 340B drugs at a rate 418
lower than that paid for the same drug to non -340B entities on 419
the basis that the claim is for a 340B drug. 420
(b) Impose any terms or conditions on the 340B entity 421
which differ from such terms or conditions applied to non -340B 422
entities on the basis that the entity participates in the 340B 423
Drug Discount Program set forth in 42 U.S.C. s. 256b or that a 424
drug is a 340B drug, including, but not limited to, any of the 425
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
following terms or conditions relating to: 426
1. Fees, charges, clawbacks, or other adjustments or 427
assessments. For purposes of this subparagraph, the term "other 428
adjustments" includes, but is not limited to , placing any 429
additional requirements, restrictions, or unnecessary burdens on 430
the 340B entity which result in administrative costs or fees to 431
the 340B entity which are not placed on non -340B entities, 432
including affiliate pharmacies or in -network pharmacies of the 433
health maintenance organization or of the pharmacy benefit 434
manager. 435
2. Dispensation of fees that are less than such fees for 436
non-340B entities. 437
3. Restrictions or requirements regarding participation in 438
standard or preferred pharmacy networks. 439
4. Requirements relating to the frequency or scope of 440
audits of inventory management systems. 441
5. Requirements that a claim for a drug include any 442
identification, billing modifier, attestation, or other 443
indication that a drug is a 340B drug in order to be processed 444
or resubmitted unless it is required by the Centers for Medicare 445
and Medicaid Services or the Agency for Health Care 446
Administration for the administration of the Medicaid program. 447
6. Any other restrictions, conditions, practices, or 448
policies that are not imposed on non -340B entities. 449
(c) Require the 340B entity to reverse, resubmit, or 450
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
clarify a claim after the initial adjudication unless these 451
actions are in the normal course of pharmacy business and not 452
related to 340B drug pricing. 453
(d) Base an action or contract requirement solely on the 454
basis that the entity is a participant in the 340B Drug Discount 455
Program in such a manner that prevents or interferes with any 456
patient's choice to receive such drugs from the 340B entity, 457
including the creation of a restriction or additional charge on 458
a patient who chooses to receive drugs from a 340B entity 459
through direct dispensing, delivery, mail order, or 460
administration of such drugs, regardless of the type of 461
insurance coverage or medication. For p urposes of this 462
paragraph, it is considered a prohibited practice that prevents 463
or interferes with a patient's choice to receive drugs at a 340B 464
entity if the health maintenance organization, or the pharmacy 465
benefit manager on behalf of the health maintena nce 466
organization, places any additional requirements, restrictions, 467
or unnecessary burdens on the 340B entity beyond that of any 468
other pharmacy dispensing medications within the scope of 469
Florida law, including, but not limited to, requiring a claim 470
for a drug to include any identification, billing modifier, 471
attestation, or other indication that a drug is a 340B drug in 472
order to be processed or resubmitted, unless it is required by 473
the Centers for Medicare and Medicaid Services or the Agency for 474
Health Care Administration in administration of the Medicaid 475
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CODING: Words stricken are deletions; words underlined are additions.
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
program. 476
(e) Require or compel the submission of ingredient costs 477
or pricing data pertaining to 340B drugs to the health 478
maintenance organization or the pharmacy benefit manager. 479
(f) Exclude the 340B ent ity from the network of the health 480
maintenance organization or pharmacy benefit manager on the 481
basis that the 340B entity dispenses drugs subject to an 482
agreement under 42 U.S.C. s. 256b, or refuse to contract with 483
the 340B entity for reasons other than tho se that apply equally 484
to non-340B entities. 485
(3) Subsection (2) does not apply to the Medicaid program 486
as payor when Medicaid provides reimbursement for covered 487
outpatient drugs as defined in 42 U.S.C. s. 1396r -8(k). 488
(4) The commission of any act prohibited by this section 489
is a deceptive and unfair trade practice, constitutes a 490
violation of the Florida Deceptive and Unfair Trade Practices 491
Act under part II of chapter 501, and subjects the violator to 492
all actions, including, but not limited to, inve stigative 493
demands, remedies, and penalties provided for in the Florida 494
Deceptive and Unfair Trade Practices Act. Each commission of a 495
prohibited act constitutes a violation of the Florida Deceptive 496
and Unfair Trade Practices Act. 497
Section 6. This act shall take effect July 1, 2025. 498