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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 prescription drug price 2
transparency; amending s. 499.012, F.S.; prohibiting 3
permits for prescription drug manufacturers and 4
nonresident prescription drug manufacturers and for 5
certain wholesale distributors of prescription drugs 6
from being renewed unless specified requirements are 7
met; authorizing the Department of Business and 8
Professional Regulation to suspend or revoke 9
manufacturer permits and wholesale distributor permits 10
under specified circumstances; amending s. 499.0121, 11
F.S.; defining the term "price"; providing reporting 12
requirements for certain entities that engage in 13
wholesale distributions of prescription drugs; 14
authorizing the department to request certain 15
documentation and information; requiring the 16
department to prescribe b y rule specified timeframes; 17
authorizing the department to extend specified 18
timeframes; specifying what constitutes violations of 19
specified laws; providing penalties and fines for 20
violations; providing disposition of such fines; 21
creating s. 499.026, F.S.; providing definitions; 22
providing requirements for notifications by 23
manufacturers of prescription drug price increases 24
under certain circumstances; providing reporting 25
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requirements; requiring the department to compile a 26
list of specified drugs; authorizing the department to 27
request certain documentation and information; 28
requiring the department to prescribe by rule 29
specified timeframes; authorizing the department to 30
extend specified timeframes; providing duties of the 31
department; specifying what constitutes violations of 32
specified laws; prohibiting certain prescription drugs 33
from being included in specified drug formularies; 34
providing an exception; providing penalties and fines 35
for violations; providing disposition of such fines; 36
requiring the department to a dopt rules; amending s. 37
499.05, F.S.; requiring the department to adopt rules; 38
conforming provisions to changes made by the act; 39
amending s. 624.490, F.S.; providing definitions; 40
providing reporting requirements for registered 41
pharmacy benefit managers; au thorizing the Office of 42
Insurance Regulation to request certain documentation 43
and information; requiring the Financial Services 44
Commission to prescribe by rule specified timeframes; 45
authorizing the office to extend specified timeframes; 46
requiring registered pharmacy benefit managers to 47
maintain a website for a specified purpose and to 48
update the information on the website under certain 49
circumstances; specifying what constitutes violations 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
of specified laws; providing penalties and fines for 51
violations; providing disposition of such fines; 52
creating ss. 627.42384 and 641.3131, F.S.; requiring 53
certain health insurers and health maintenance 54
organizations, respectively, to submit and update 55
contact information for single points of contact for a 56
specified use; requiring the office to maintain and 57
publish such points of contact; requiring such health 58
insurers and health maintenance organizations to 59
notify certain insureds and subscribers, respectively, 60
within a specified timeframe of drug formulary 61
changes; providing applicability; amending ss. 62
627.64741, 627.6572, and 641.314, F.S.; defining the 63
term "net price"; providing additional requirements 64
for contracts between pharmacy benefit managers and 65
individual health insurers, group health insurers, and 66
health maintenance organizations, respectively; 67
providing applicability; amending ss. 110.12315, 68
409.815, 409.91195, 409.912, and 499.067, F.S.; 69
conforming provisions to changes made by the act; 70
providing an effective date. 71
72
Be It Enacted by the Legislature of the S tate of Florida: 73
74
Section 1. Paragraph (f) is added to subsection (1) of 75
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section 499.012, Florida Statutes, to read: 76
499.012 Permit application requirements. — 77
(1) 78
(f)1. A permit for a prescription drug manufacturer or 79
nonresident prescription drug manufacturer may not be renewed 80
unless the prescription drug manufacturer or nonresident 81
prescription drug manufacturer meets the requirements of s. 82
499.026. The department may suspend or revoke the permit of a 83
manufacturer that fails to comply with the r equirements of s. 84
499.026. 85
2. A permit for a prescription drug wholesale distributor, 86
out-of-state prescription drug wholesale distributor, retail 87
pharmacy drug wholesale distributor, veterinary prescription 88
drug wholesale distributor, or limited prescri ption drug 89
veterinary wholesale distributor may not be renewed unless the 90
wholesale distributor meets the requirements of s. 499.0121(16). 91
The department may suspend or revoke the permit of a wholesale 92
distributor that fails to comply with the requirements of s. 93
499.0121(16). 94
Section 2. Subsection (16) is added to section 499.0121, 95
Florida Statutes, to read: 96
499.0121 Storage and handling of prescription drugs; 97
recordkeeping; prescription drug price report requirements; 98
penalties for noncompliance .—The department shall adopt rules to 99
implement this section as necessary to protect the public 100
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health, safety, and welfare. Such rules shall include, but not 101
be limited to, requirements for the storage and handling of 102
prescription drugs and for the establishme nt and maintenance of 103
prescription drug distribution records. 104
(16) PRESCRIPTION DRUG PRICE REPORT AND PENALTIES FOR 105
NONCOMPLIANCE.— 106
(a) As used in this subsection, the term "price" means the 107
manufacturer's list price for a prescription drug to wholesal ers 108
or direct purchasers in the United States, not including prompt 109
pay or other discounts, rebates, or reductions in price, for the 110
most recent month for which the information is available, as 111
reported in wholesale price guides or other publications of dr ug 112
or biological pricing data. 113
(b) By July 1 of each year, each prescription drug 114
wholesale distributor, out -of-state prescription drug wholesale 115
distributor, retail pharmacy drug wholesale distributor, 116
prescription drug wholesale distributor, veterinary prescription 117
drug wholesale distributor, or limited prescription drug 118
veterinary wholesale distributor, or each manufacturer or 119
repackager that engages in the wholesale distribution of 120
prescription drugs, shall submit a report to the department on 121
each prescription drug for which the price, during the previous 122
calendar year: 123
1. Was $100 or more for a 30 -day supply or for a course of 124
treatment lasting less than 30 days; or 125
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2. Increased by at least 10 percent over the previous 126
price. 127
(c) The report must include, at a minimum, the following 128
information: 129
1. The name and the price at the time of the report of 130
each prescription drug specified in paragraph (b) and the 131
cumulative percentage price increase during the previous 132
calendar year. 133
2. The length of time the prescription drug has been on 134
the market. 135
3. The factors that contributed to the price increase. 136
4. The name of any generic version of the prescription drug 137
available on the market. 138
5. The total sales revenue for the prescription drug 139
during the previous calendar year. 140
6. The introductory price of the prescription drug when it 141
was approved by the United States Food and Drug Administration 142
and the cumulative yearly increase, by calendar year, in the 143
price of the drug during the previous 5 years or during the 144
number of years the drug has been on the market, whichever is 145
less. 146
7. Any prompt pay or discount, rebate, or reduction in 147
price provided by the reporting wholesale distributor or 148
manufacturer or repackager that engages in the wholesa le 149
distribution of prescription drugs when selling a prescription 150
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drug to a manufacturer, pharmacy, pharmacy benefit manager, and 151
other entities. 152
8. The documentation necessary to support the information 153
reported under this paragraph. 154
(d) The department may make a written request to the 155
reporting wholesale distributor, manufacturer, or repackager for 156
supporting documentation or additional information concerning 157
the report. The department shall prescribe by rule the 158
timeframes for the department's reques t for documentation or 159
information and for the response by the reporting wholesale 160
distributor, manufacturer, or repackager. The department may 161
extend the timeframe, if necessary, for the response by the 162
wholesale distributor, manufacturer, or repackager. 163
(e) A wholesale distributor, or a manufacturer or 164
repackager that engages in the wholesale distribution of 165
prescription drugs, violates this subsection if the wholesale 166
distributor, manufacturer, or repackager: 167
1. Fails to timely submit the report requ ired under this 168
subsection; 169
2. Fails to provide information required under this 170
subsection; 171
3. Fails to timely respond to a written request by the 172
department with regard to the report required under this 173
subsection; or 174
4. Provides inaccurate or incom plete information in the 175
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report required under this subsection. 176
(f)1. The department may deny an application for a renewal 177
permit or registration or suspend or revoke a registration 178
certificate or a permit of a prescription drug wholesale 179
distributor, or a manufacturer or repackager that engages in the 180
wholesale distribution of prescription drugs, for violating this 181
subsection. 182
2.a. The department may also impose an administrative 183
fine, not to exceed $5,000 per violation per day, for a 184
violation of this subsection or a rule adopted to administer 185
this subsection. Each day the violation continues constitutes a 186
separate violation, and each such separate violation is subject 187
to a separate fine. 188
b. In determining the amount of fine to be levied for a 189
violation of this subsection, the department must consider the 190
following factors: 191
(I) The severity of the violation. 192
(II) Any action taken by the permittee to correct the 193
violation or to remedy complaints. 194
(III) Any previous violation. 195
c. All fines collected under this subparagraph shall be 196
deposited into the Public Medical Assistance Trust Fund 197
administered by the Agency for Health Care Administration, to be 198
used to help the uninsured pay for health care. 199
Section 3. Section 499.026, Florida Statutes, is created 200
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to read: 201
499.026 Prescription drug price transparency. — 202
(1) As used in this section, the term: 203
(a) "Agency" means the Agency for Health Care 204
Administration. 205
(b) "Division" means the Division of Consumer Services of 206
the Department of Agr iculture and Consumer Services. 207
(c) "Drug" means a prescription drug. 208
(d) "Health insurer" means a health insurer issuing major 209
medical coverage through an individual or group policy or a 210
health maintenance organization issuing major medical coverage 211
through an individual or group contract, regulated under chapter 212
627 or chapter 641. 213
(e) "Medicaid" means the Agency for Health Care 214
Administration Medicaid program. 215
(f) "Office" means the Office of Insurance Regulation of 216
the Financial Services Commission. 217
(g) "Price" means the manufacturer's list price for a drug 218
to wholesalers or direct purchasers in the United States, not 219
including prompt pay or other discounts, rebates, or reductions 220
in price, for the most recent month for which the informa tion is 221
available, as reported in wholesale price guides or other 222
publications of drug or biological pricing data. 223
(2)(a) At least 120 days before the effective date of any 224
single manufacturer increase of at least 10 percent in the price 225
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of a drug, a manufacturer must provide notice of the upcoming 226
drug price increase to: 227
1. The department, the Department of Health, the agency, 228
the division, and the office. 229
2. Every health insurer that covers the drug. The 230
manufacturer shall use the contact list published by the office 231
under ss. 627.42384 and 641.3131 to provide notice to health 232
insurers. Notification shall be presumed to occur on the date 233
that the manufacturer attempts to communicate with the 234
applicable point of contact published by the office. 235
(b) The notices must include, at a minimum, the following 236
information: 237
1. The name and current price of the drug. 238
2. The date that the increase will become effective. 239
3. The dollar amount of the intended increase in the price 240
of the drug. 241
4. The percentage price increase. 242
5. A statement of whether the price increase is 243
necessitated by a change or improvement of the drug and, if so, 244
a description of the change or improvement. 245
6. A description of any other factors that contributed to 246
the price increase. 247
7. The documentation necessary to support the information 248
reported under subparagraphs 5. and 6. 249
(3)(a) By July 1 of each year, a manufacturer shall submit 250
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a report to the department, the Department of Health, the 251
agency, the division, and the office on each drug for which the 252
price, during the previous calendar year: 253
1. Was $100 or more for a 30 -day supply or for a course of 254
treatment lasting less than 30 days; or 255
2. Increased by at least 10 percent over the previous 256
price in a single manuf acturer price. 257
(b) The report must include, at a minimum, the following 258
information: 259
1. The name and the price at the time of the report of 260
each drug specified in paragraph (a) and the cumulative 261
percentage price increase during the previous calendar y ear. 262
2. The length of time the drug has been on the market. 263
3. The factors that contributed to the price increase. 264
4. The name of any generic version of the drug available on 265
the market. 266
5. The research and development costs associated with the 267
drug that were paid using public funds. 268
6. The direct costs incurred by the manufacturer to 269
manufacture, market, and distribute the drug and to ensure 270
ongoing safety and effectiveness research associated with the 271
drug. 272
7. The total sales revenue for the dr ug during the 273
previous calendar year. 274
8. The manufacturer's profit attributable to the drug 275
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during the previous calendar year. 276
9. The introductory price of the drug when it was approved 277
by the United States Food and Drug Administration and the 278
cumulative yearly increase, by calendar year, in the price of 279
the drug during the previous 5 years or during the number of 280
years the drug has been on the market, whichever is less. 281
10. The 10 highest prices paid for the drug during the 282
previous year in other cou ntries. 283
11. The documentation necessary to support the information 284
reported under this paragraph. 285
(4)(a) Before reviewing the data in the report filed under 286
subsection (3), the department, in consultation with the 287
Department of Health, the agency, and the office, shall compile 288
a list of drugs that have a significant cost to the state or 289
that are designated as being critical to public health. Such 290
drugs may be sourced from the Medicaid drug utilization data and 291
drug spending data, the division's drug spe nding data, and the 292
drug spending data of health insurers and health plans and their 293
pharmacy benefit managers. 294
(b) After receiving the report required under subsection 295
(3), the department: 296
1. May make a written request to the manufacturer for 297
supporting documentation or additional information concerning 298
the report. The department shall prescribe by rule the 299
timeframes for the department's request for documentation or 300
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information and for the manufacturer's response to the request. 301
The department may extend the timeframe, if necessary, for the 302
manufacturer's response. 303
2. Shall review the costs and the factors contributing to 304
each drug price or drug price increase in the report. 305
3. Shall review the price and price increase of each drug 306
on the list compiled under paragraph (a) and each drug on the 307
lists reported by wholesale distributors and other entities 308
engaged in wholesale distribution of prescription drugs and by 309
registered pharmacy bene fit managers under ss. 499.0121(16) and 310
624.490(6)(b), respectively, to make sure that any drug on the 311
compiled and reported lists which fits the criterion in 312
subparagraph (3)(a)1. or subparagraph (3)(a)2. is also reported 313
by the drug's manufacturer under subsection (3). 314
4. Shall, in consultation with the Department of Health, 315
the division, and the office, determine whether the manufacturer 316
has violated this section. 317
(5) A manufacturer violates this section if the 318
manufacturer: 319
(a) Fails to timely sub mit notices or reports required 320
under this section; 321
(b) Fails to provide information required under this 322
section; 323
(c) Fails to timely respond to a written request by the 324
department with regard to the notices or report required under 325
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this section; or 326
(d) Provides inaccurate or incomplete information in the 327
notices or report required under this section. 328
(6) A drug for which the manufacturer does not comply with 329
the notification or reporting requirements under this section 330
may not be included in the Me dicaid's and state group health 331
insurance's drug formularies unless the drug is the most 332
clinically appropriate, clinically effective, and lowest net -333
cost drug. 334
(7)(a) The department may deny an application for a 335
renewal permit or suspend or revoke a per mit of a prescription 336
drug manufacturer or nonresident prescription drug manufacturer 337
for violating this section. 338
(b)1. The department may also impose an administrative 339
fine, not to exceed $5,000 per violation per day, for a 340
violation of this section or a rule adopted under this section. 341
Each day the violation continues constitutes a separate 342
violation, and each such separate violation is subject to a 343
separate fine. 344
2. In determining the amount of fine to be levied for a 345
violation of this section, the d epartment, in consultation with 346
the Department of Health, the agency, the division, and the 347
office, must consider the following factors: 348
a. The severity of the violation. 349
b. Any action taken by the permittee to correct the 350
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violation or to remedy compla ints. 351
c. Any previous violation. 352
3. All fines collected under this section shall be 353
deposited into the Public Medical Assistance Trust Fund 354
administered by the agency, to be used to help the uninsured pay 355
for health care. 356
(8) The department shall ado pt rules to administer this 357
section. 358
Section 4. Paragraph (m) of subsection (1) of section 359
499.05, Florida Statutes, is amended, and paragraph (o) is added 360
to that subsection, to read: 361
499.05 Rules.— 362
(1) The department shall adopt rules to implemen t and 363
enforce this chapter with respect to: 364
(m) Wholesale distributor reporting requirements of s. 365
499.0121(14) and (16) s. 499.0121(14). 366
(o) Manufacturer notification and reporting requirements 367
of s. 499.026(2) and (3). 368
Section 5. Subsection (6) of section 624.490, Florida 369
Statutes, is renumbered as subsection (7), and a new subsection 370
(6) is added to that section, to read: 371
624.490 Registration of pharmacy benefit managers ; 372
prescription drug price report and public access requirements; 373
penalties for noncompliance.— 374
(6)(a) As used in this subsection, the term: 375
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1. "Negotiated price" means the value at which a 376
prescription drug is sold by a prescription drug manufacturer, 377
prescription drug wholesale distributor, or pharmacy, under a 378
prescription drug benefits coverage administered by a pharmacy 379
benefit manager, before any tax or cost is added and any 380
discount, rebate, or reduction in price, including a rebate 381
offered to the pharmacy benefit manager, is subtracted. 382
2. "Net price" means the value at which a prescription 383
drug is sold by a prescription drug manufacturer, prescription 384
drug wholesale distributor, or pharmacy, under a prescription 385
drug benefits coverage administered by a pharmacy benefit 386
manager, after all taxes and other costs are add ed and all 387
discounts, rebates, and reductions in price are subtracted, 388
including any rebate offered to the pharmacy benefit manager 389
which is passed on to the health insurer or health maintenance 390
organization. 391
3. "Rebate offered to a pharmacy benefit manager" means a 392
direct payment by a prescription drug manufacturer, prescription 393
drug wholesale distributor, or pharmacy to a pharmacy benefit 394
manager for a prescription drug dispensed to an insured or 395
subscriber. Such payment serves an incentive for the pharmacy 396
benefit manager to promote use of the prescription drug, and the 397
pharmacy benefit manager may choose to keep the payment or to 398
pass it on, in full or in part, to the health insurer or health 399
maintenance organization. 400
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(b)1. By July 1 of each year , a registered pharmacy 401
benefit manager shall submit a report to the office on each 402
prescription drug for which the negotiated price, during the 403
previous calendar year: 404
a. Was $100 or more for a 30 -day supply or for a course of 405
treatment lasting less tha n 30 days; or 406
b. Increased by at least 10 percent over the previous 407
negotiated price. 408
2. The report must include, at a minimum, the following 409
information: 410
a. The name and the negotiated price at the time of the 411
report of each prescription drug specif ied in subparagraph 1. 412
and the cumulative percentage negotiated price increase during 413
the previous calendar year. 414
b. The name of any generic version of the prescription drug 415
available on the market. 416
c. The total sales revenue of the pharmacy benefit man ager 417
for the prescription drug during the previous calendar year. 418
d. The documentation necessary to support the information 419
reported under this paragraph. 420
3. The office may make a written request to the pharmacy 421
benefit manager for supporting documenta tion or additional 422
information concerning the report. The commission shall 423
prescribe by rule the timeframes for the office's request for 424
documentation or information and for the pharmacy benefit 425
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manager's response to the request. The office may extend the 426
timeframe, if necessary, for the pharmacy benefit manager's 427
response. 428
(c) A registered pharmacy benefit manager shall maintain a 429
website that provides public access to the net price of each 430
prescription drug. The registered pharmacy benefit manager shall 431
update the net price of a prescription drug on the website at 432
least 90 days before the net price of the prescription drug 433
changes. 434
(d) A registered pharmacy benefit manager violates this 435
subsection if the registered pharmacy benefit manager: 436
1. Fails to timely submit the report required under 437
paragraph (b); 438
2. Fails to provide information required under paragraph 439
(b); 440
3. Fails to timely respond to a written request by the 441
office with regard to the report required under paragraph (b); 442
4. Provides inaccurate or incomplete information in the 443
report required under paragraph (b); or 444
5. Fails to maintain a website for access to net prices of 445
prescription drugs or to update the net prices on the website, 446
as required under paragraph (c). 447
(e)1. The office may deny an application for renewal 448
registration or suspend or revoke a registration certificate of 449
a pharmacy benefit manager for violating this subsection. 450
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2.a. The office may also impose an administrative fine, 451
not to exceed $5,000 per violation p er day, for a violation of 452
this subsection or a rule adopted to administer this subsection. 453
Each day the violation continues constitutes a separate 454
violation, and each such separate violation is subject to a 455
separate fine. 456
b. In determining the amount of fine to be levied for a 457
violation of this subsection, the office must consider the 458
following factors: 459
(I) The severity of the violation. 460
(II) Any action taken by the pharmacy benefit manager to 461
correct the violation or to remedy complaints. 462
(III) Any previous violation. 463
c. All fines collected under this subsection shall be 464
deposited into the Public Medical Assistance Trust Fund 465
administered by the Agency for Health Care Administration, to be 466
used to help the uninsured pay for health care. 467
Section 6. Section 627.42384, Florida Statutes, is created 468
to read: 469
627.42384 Formulary changes resulting from drug price 470
increases.— 471
(1) A health insurer issuing a major medical individual or 472
group policy shall submit, and update as necessary, contact 473
information for a single point of contact for use by 474
prescription drug manufacturers to comply with s. 499.026. The 475
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office shall maintain and publish on its website a list of such 476
points of contact. 477
(2) A health insurer issuing a major medical individual or 478
group policy must provide written notice to each affected 479
insured and each prescribing health care provider at least 90 480
days before making a drug formulary change that results from a 481
prescription drug price increase reported by a drug manufacturer 482
under s. 499.026(2). 483
(3) This section applies to policies entered into or 484
renewed on or after January 1, 2023. 485
Section 7. Paragraph (b) of subsection (1) of section 486
627.64741, Florida Statutes, is redesignated as paragraph (c), 487
subsection (5) is amended, a new paragraph (b) is added to 488
subsection (1), and paragraphs (c) through (f) are added to 489
subsection (2) of that section, to read: 490
627.64741 Pharmacy benefit manager contracts. — 491
(1) As used in this section, the term: 492
(b) "Net price" means the value a t which a prescription 493
drug is sold by a prescription drug manufacturer, prescription 494
drug wholesale distributor, or pharmacy, under a prescription 495
drug benefits coverage administered by a pharmacy benefit 496
manager, after all taxes and other costs are added and all 497
discounts, rebates, and reductions in price are subtracted, 498
including any rebate offered to the pharmacy benefit manager 499
which is passed on to the health insurer. 500
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(2) A contract between a health insurer and a pharmacy 501
benefit manager must requir e that the pharmacy benefit manager: 502
(c) Maintain a website that provides public access to the 503
net price of each covered prescription drug and update the net 504
price of a covered prescription drug on the website at least 90 505
days before the net price of the covered prescription drug 506
changes. 507
(d) Provide written notice to each affected insured and 508
each prescribing health care provider at least 90 days before 509
making a change in the drug formulary or in the net price of a 510
covered prescription drug, including a change that results from 511
a price increase of a covered prescription drug reported by a 512
drug manufacturer under s. 499.026(2). 513
(e) Inform an affected insured, in writing, of the net 514
price of each covered prescription drug for which the insured 515
has made a payment. 516
(f) Provide in writing to each insured and each 517
prescribing health care provider the address of the pharmacy 518
benefit manager's website where the list of the net prices of 519
all prescription drugs is posted. 520
(5) This section applies to contract s entered into or 521
renewed on or after July 1, 2022 July 1, 2018. 522
Section 8. Paragraph (b) of subsection (1) of section 523
627.6572, Florida Statutes, is redesignated as paragraph (c), 524
subsection (5) is amended, a new paragraph (b) is added to 525
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subsection (1), and paragraphs (c) through (f) are added to 526
subsection (2) of that section, to read: 527
627.6572 Pharmacy benefit manager contracts. — 528
(1) As used in this section, the term: 529
(b) "Net price" means the value at which a prescription 530
drug is sold by a prescription drug manufacturer, prescription 531
drug wholesale distributor, or pharmacy, under a prescription 532
drug benefits coverage administered by a pharmacy benefit 533
manager, after all taxes and other costs are added and all 534
discounts, rebates, and reductio ns in price are subtracted, 535
including any rebate offered to the pharmacy benefit manager 536
which is passed on to the health insurer. 537
(2) A contract between a health insurer and a pharmacy 538
benefit manager must require that the pharmacy benefit manager: 539
(c) Maintain a website that provides public access to the 540
net price of each covered prescription drug and update the net 541
price of a covered prescription drug on the website at least 90 542
days before the net price of the covered prescription drug 543
changes. 544
(d) Provide written notice to each affected insured and 545
each prescribing health care provider at least 90 days before 546
making a change in the drug formulary or in the net price of a 547
covered prescription drug, including a change that results from 548
a price increase of a covered prescription drug reported by a 549
drug manufacturer under s. 499.026(2). 550
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(e) Inform an insured, in writing, of the net price of 551
each covered prescription drug for which the insured has made a 552
payment. 553
(f) Provide in writing to each insure d and each 554
prescribing health care provider the address of the pharmacy 555
benefit manager's website where the list of the net prices of 556
all covered prescription drugs is posted. 557
(5) This section applies to contracts entered into or 558
renewed on or after July 1, 2022 July 1, 2018. 559
Section 9. Section 641.3131, Florida Statutes, is created 560
to read: 561
641.3131 Formulary changes resulting from drug price 562
increases.— 563
(1) A health maintenance organization issuing a major 564
medical or other comprehensive coverage contract shall submit, 565
and update as necessary, contact information for a single point 566
of contact for use by prescription drug manufacturers to comply 567
with s. 499.026. The office shall maintain and publish on its 568
website a list of such points of contact. 569
(2) A health maintenance organization issuing a major 570
medical or other comprehensive coverage contract must provide 571
written notice to each affected subscriber and each prescribing 572
health care provider at least 90 days before making a drug 573
formulary change that results from a prescription drug price 574
increase reported by a drug manufacturer under s. 499.026(2). 575
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(3) This section applies to contracts entered into or 576
renewed on or after January 1, 2023. 577
Section 10. Paragraph (b) of subsection (1) of 641. 314, 578
Florida Statutes, is redesignated as paragraph (c), subsection 579
(5) is amended, a new paragraph (b) is added to subsection (1), 580
and paragraphs (c) through (f) are added to subsection (2) of 581
that section, to read: 582
641.314 Pharmacy benefit manager cont racts.— 583
(1) As used in this section, the term: 584
(b) "Net price" means the value at which a prescription 585
drug is sold by a prescription drug manufacturer, prescription 586
drug wholesale distributor, or pharmacy, under a prescription 587
drug benefits coverage a dministered by a pharmacy benefit 588
manager, after all taxes and other costs are added and all 589
discounts, rebates, and reductions in price are subtracted, 590
including any rebate offered to the pharmacy benefit manager 591
which is passed on to the health maintenan ce organization. 592
(2) A contract between a health maintenance organization 593
and a pharmacy benefit manager must require that the pharmacy 594
benefit manager: 595
(c) Maintain a website that provides public access to the 596
net price of each covered prescription drug and update the net 597
price of a covered prescription drug on the website at least 90 598
days before the net price of the covered prescription drug 599
changes. 600
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(d) Provide written notice to each affected subscriber and 601
each prescribing health care provider a t least 90 days before 602
making a change in the drug formulary or in the net price of a 603
covered prescription drug, including a change that results from 604
a price increase of a covered prescription drug reported by a 605
drug manufacturer under s. 499.026(2). 606
(e) Inform a subscriber in writing of the net price of 607
each covered prescription drug for which the subscriber has made 608
a payment. 609
(f) Provide in writing to each subscriber and each 610
prescribing health care provider the address of the pharmacy 611
benefit manager's website where the list of the net prices of 612
all prescription drugs is posted. 613
(5) This section applies to contracts entered into or 614
renewed on or after July 1, 2022 July 1, 2018. 615
Section 11. Subsections (3) and (4) and paragraph (a) of 616
subsection (9) of section 110.12315, Florida Statutes, are 617
amended to read: 618
110.12315 Prescription drug program. —The state employees' 619
prescription drug program is established. This program shall be 620
administered by the Department of Management Services, according 621
to the terms and conditions of the plan as established by the 622
relevant provisions of the annual General Appropriations Act and 623
implementing legislation, subject to the following conditions: 624
(3) The department shall maintain the generic, preferred 625
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brand name, and the nonpreferred brand name lists of drugs and 626
supplies to be used in the administration of the state 627
employees' prescription drug program. These lists may not 628
include a prescription drug for which the prescription drug 629
manufacturer does not comply with the requirements of s. 499.026 630
unless the prescription drug is the most clinically appropriate, 631
clinically effective, and lowest net -cost prescription drug. 632
(4) The department shall maintain a list of maintenance 633
drugs and supplies. The list may not include a drug for which 634
the prescription drug manufacturer does not comply with the 635
requirements of s. 499.026 unless the prescription drug is the 636
most clinically appropriate, clinically effective, and lowest 637
net-cost prescription drug. 638
(a) Preferred provider organization health plan members 639
may have prescriptions for maintenance drugs and supplies filled 640
up to three times as a supply for up to 30 days through a retail 641
pharmacy; thereafter, prescriptions for the same maintenance 642
drug or supply must be filled for up to 90 days either through 643
the department's contracted mail order pharmacy or through a 644
retail pharmacy. 645
(b) Health maintenance organization health plan members 646
may have prescriptions for maintenance drugs and supplies filled 647
for up to 90 days either through a mail order pharmacy or 648
through a retail pharmacy. 649
(9)(a) Beginning with the 2020 plan year, the department 650
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must implement formulary management for prescription drugs and 651
supplies. Such management practices must require prescription 652
drugs to be subject to formulary inclusion or exclusion and, 653
beginning with the 2023 plan year, must require a prescription 654
drug for which the prescription drug manufacturer does not 655
comply with the requirements of s. 499.026 to be subject to 656
formulary exclusion, but may not restrict access to the most 657
clinically appropriate, clinically effective, and lowest net -658
cost prescription drugs and supplies. Drugs excluded from the 659
formulary must be available for inclusion if a physician, 660
advanced practice registered nurse, or physician assistant 661
prescribing a pharmaceutical clearly states on the prescription 662
that the excluded drug is medically necessary. Prescription 663
drugs and supplies first made available in the marketplace after 664
January 1, 2020, may not be covered b y the prescription drug 665
program until specifically included in the list of covered 666
prescription drugs and supplies. 667
Section 12. Paragraph (n) of subsection (2) of section 668
409.815, Florida Statutes, is amended to read: 669
409.815 Health benefits coverage ; limitations.— 670
(2) BENCHMARK BENEFITS. —In order for health benefits 671
coverage to qualify for premium assistance payments for an 672
eligible child under ss. 409.810 -409.821, the health benefits 673
coverage, except for coverage under Medicaid and Medikids, must 674
include the following minimum benefits, as medically necessary. 675
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(n) Prescribed drugs. — 676
1. Coverage shall include drugs prescribed for the 677
treatment of illness or injury when prescribed by a licensed 678
health practitioner acting within the scope of his or her 679
practice. 680
2. Prescribed drugs may be limited to generics if 681
available and brand name products if a generic substitution is 682
not available, unless the prescribing licensed health 683
practitioner indicates that a brand name is medically necessary. 684
3. Prescribed drugs covered under this section shall 685
include all prescribed drugs covered under the Florida Medicaid 686
program. 687
4. Prescribed drugs may not include a prescription drug 688
for which the manufacturer does not comply with the requirements 689
of s. 499.026 unless the prescription drug is the most 690
clinically appropriate, clinically effective, and lowest net -691
cost prescription drug or unless a physician, advanced practice 692
registered nurse, or physician assistant prescribing the drug 693
clearly states on the pres cription that the excluded drug is 694
medically necessary. 695
Section 13. Subsection (8) of section 409.91195, Florida 696
Statutes, is amended to read: 697
409.91195 Medicaid Pharmaceutical and Therapeutics 698
Committee.—There is created a Medicaid Pharmaceutical an d 699
Therapeutics Committee within the agency for the purpose of 700
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developing a Medicaid preferred drug list. 701
(8) The committee shall develop its preferred drug list 702
recommendations by considering the clinical efficacy, safety, 703
and cost-effectiveness of a pro duct and the manufacturer's 704
prescription drug price transparency, as required under s. 705
499.012. 706
Section 14. Paragraph (a) of subsection (5) of section 707
409.912, Florida Statutes, is amended to read: 708
409.912 Cost-effective purchasing of health care. —The 709
agency shall purchase goods and services for Medicaid recipients 710
in the most cost-effective manner consistent with the delivery 711
of quality medical care. To ensure that medical services are 712
effectively utilized, the agency may, in any case, require a 713
confirmation or second physician's opinion of the correct 714
diagnosis for purposes of authorizing future services under the 715
Medicaid program. This section does not restrict access to 716
emergency services or poststabilization care services as defined 717
in 42 C.F.R. s. 438.114. Such confirmation or second opinion 718
shall be rendered in a manner approved by the agency. The agency 719
shall maximize the use of prepaid per capita and prepaid 720
aggregate fixed-sum basis services when appropriate and other 721
alternative service deliv ery and reimbursement methodologies, 722
including competitive bidding pursuant to s. 287.057, designed 723
to facilitate the cost -effective purchase of a case -managed 724
continuum of care. The agency shall also require providers to 725
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minimize the exposure of recipient s to the need for acute 726
inpatient, custodial, and other institutional care and the 727
inappropriate or unnecessary use of high -cost services. The 728
agency shall contract with a vendor to monitor and evaluate the 729
clinical practice patterns of providers in order to identify 730
trends that are outside the normal practice patterns of a 731
provider's professional peers or the national guidelines of a 732
provider's professional association. The vendor must be able to 733
provide information and counseling to a provider whose pract ice 734
patterns are outside the norms, in consultation with the agency, 735
to improve patient care and reduce inappropriate utilization. 736
The agency may mandate prior authorization, drug therapy 737
management, or disease management participation for certain 738
populations of Medicaid beneficiaries, certain drug classes, or 739
particular drugs to prevent fraud, abuse, overuse, and possible 740
dangerous drug interactions. The Pharmaceutical and Therapeutics 741
Committee shall make recommendations to the agency on drugs for 742
which prior authorization is required. The agency shall inform 743
the Pharmaceutical and Therapeutics Committee of its decisions 744
regarding drugs subject to prior authorization. The agency is 745
authorized to limit the entities it contracts with or enrolls as 746
Medicaid providers by developing a provider network through 747
provider credentialing. The agency may competitively bid single -748
source-provider contracts if procurement of goods or services 749
results in demonstrated cost savings to the state without 750
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limiting access to car e. The agency may limit its network based 751
on the assessment of beneficiary access to care, provider 752
availability, provider quality standards, time and distance 753
standards for access to care, the cultural competence of the 754
provider network, demographic chara cteristics of Medicaid 755
beneficiaries, practice and provider -to-beneficiary standards, 756
appointment wait times, beneficiary use of services, provider 757
turnover, provider profiling, provider licensure history, 758
previous program integrity investigations and find ings, peer 759
review, provider Medicaid policy and billing compliance records, 760
clinical and medical record audits, and other factors. Providers 761
are not entitled to enrollment in the Medicaid provider network. 762
The agency shall determine instances in which allo wing Medicaid 763
beneficiaries to purchase durable medical equipment and other 764
goods is less expensive to the Medicaid program than long -term 765
rental of the equipment or goods. The agency may establish rules 766
to facilitate purchases in lieu of long -term rentals in order to 767
protect against fraud and abuse in the Medicaid program as 768
defined in s. 409.913. The agency may seek federal waivers 769
necessary to administer these policies. 770
(5)(a) The agency shall implement a Medicaid prescribed -771
drug spending-control program that includes the following 772
components: 773
1. A Medicaid preferred drug list, which shall be a 774
listing of cost-effective therapeutic options recommended by the 775
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Medicaid Pharmacy and Therapeutics Committee established 776
pursuant to s. 409.91195 and adopted by the agency for each 777
therapeutic class on the preferred drug list. At the discretion 778
of the committee, and when feasible, the preferred drug list 779
should include at least two products in a therapeutic class. The 780
agency may post the preferred drug list and updates to the list 781
on an Internet website without following the rulemaking 782
procedures of chapter 120. Drugs for which the manufacturer does 783
not comply with the requirements of s. 499.026 are excluded from 784
the preferred list, unless the drug is the most c linically 785
appropriate, clinically effective, and lowest net -cost 786
prescription drug. Antiretroviral agents are excluded from the 787
preferred drug list. The agency shall also limit the amount of a 788
prescribed drug dispensed to no more than a 34 -day supply unless 789
the drug products' smallest marketed package is greater than a 790
34-day supply, or the drug is determined by the agency to be a 791
maintenance drug in which case a 100 -day maximum supply may be 792
authorized. The agency may seek any federal waivers necessary to 793
implement these cost -control programs and to continue 794
participation in the federal Medicaid rebate program, or 795
alternatively to negotiate state -only manufacturer rebates. The 796
agency may adopt rules to administer this subparagraph. The 797
agency shall continue to provide unlimited contraceptive drugs 798
and items. The agency must establish procedures to ensure that: 799
a. There is a response to a request for prior 800
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authorization by telephone or other telecommunication device 801
within 24 hours after receipt of a reques t for prior 802
authorization; and 803
b. A 72-hour supply of the drug prescribed is provided in 804
an emergency or when the agency does not provide a response 805
within 24 hours as required by sub -subparagraph a. 806
2. A provider of prescribed drugs is reimbursed in an 807
amount not to exceed the lesser of the actual acquisition cost 808
based on the Centers for Medicare and Medicaid Services National 809
Average Drug Acquisition Cost pricing files plus a professional 810
dispensing fee, the wholesale acquisition cost plus a 811
professional dispensing fee, the state maximum allowable cost 812
plus a professional dispensing fee, or the usual and customary 813
charge billed by the provider. 814
3. The agency shall develop and implement a process for 815
managing the drug therapies of Medicaid recipient s who are using 816
significant numbers of prescribed drugs each month. The 817
management process may include, but is not limited to, 818
comprehensive, physician -directed medical-record reviews, claims 819
analyses, and case evaluations to determine the medical 820
necessity and appropriateness of a patient's treatment plan and 821
drug therapies. The agency may contract with a private 822
organization to provide drug -program-management services. The 823
Medicaid drug benefit management program shall include 824
initiatives to manage drug t herapies for HIV/AIDS patients, 825
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patients using 20 or more unique prescriptions in a 180 -day 826
period, and the top 1,000 patients in annual spending. The 827
agency shall enroll any Medicaid recipient in the drug benefit 828
management program if he or she meets the specifications of this 829
provision and is not enrolled in a Medicaid health maintenance 830
organization. 831
4. The agency may limit the size of its pharmacy network 832
based on need, competitive bidding, price negotiations, 833
credentialing, or similar criteria. The a gency shall give 834
special consideration to rural areas in determining the size and 835
location of pharmacies included in the Medicaid pharmacy 836
network. A pharmacy credentialing process may include criteria 837
such as a pharmacy's full -service status, location, si ze, 838
patient educational programs, patient consultation, disease 839
management services, and other characteristics. The agency may 840
impose a moratorium on Medicaid pharmacy enrollment if it is 841
determined that it has a sufficient number of Medicaid -842
participating providers. The agency must allow dispensing 843
practitioners to participate as a part of the Medicaid pharmacy 844
network regardless of the practitioner's proximity to any other 845
entity that is dispensing prescription drugs under the Medicaid 846
program. A dispensing practitioner must meet all credentialing 847
requirements applicable to his or her practice, as determined by 848
the agency. 849
5. The agency shall develop and implement a program that 850
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requires Medicaid practitioners who issue written prescriptions 851
for medicinal drugs to use a counterfeit -proof prescription pad 852
for Medicaid prescriptions. The agency shall require the use of 853
standardized counterfeit -proof prescription pads by prescribers 854
who issue written prescriptions for Medicaid recipients. The 855
agency may implement the program in targeted geographic areas or 856
statewide. 857
6. The agency may enter into arrangements that require 858
manufacturers of generic drugs prescribed to Medicaid recipients 859
to provide rebates of at least 15.1 percent of the average 860
manufacturer price for the manufacturer's generic products. 861
These arrangements shall require that if a generic -drug 862
manufacturer pays federal rebates for Medicaid -reimbursed drugs 863
at a level below 15.1 percent, the manufacturer must provide a 864
supplemental rebate to the state in an amount necessary to 865
achieve a 15.1-percent rebate level. 866
7. The agency may establish a preferred drug list as 867
described in this subsection, and, pursuant to the establishment 868
of such preferred drug list, negotiate supplemental rebates from 869
manufacturers that are in addition to those required by Title 870
XIX of the Social Security Act and at no less than 14 percent of 871
the average manufacturer price as defined in 42 U.S.C. s. 1936 872
on the last day of a quarter unless the federal or supplemental 873
rebate, or both, equals or exceeds 29 percent. There is no upper 874
limit on the supplemental rebates the agency may negotiate. The 875
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agency may determine that specific products, brand -name or 876
generic, are competitive at lower rebate percentages. Agreement 877
to pay the minimum supplemental rebate percentage guarantees a 878
manufacturer that the Medicaid Pharmaceutical and Therapeutics 879
Committee will consider a product for inclusion on the preferred 880
drug list. However, a pharmaceutical manufacturer is not 881
guaranteed placement on the preferred drug list by simply paying 882
the minimum supplemental rebate. Agency decisions will be made 883
on the clinical efficacy of a drug and recommendations of the 884
Medicaid Pharmaceutical and Therapeutics Committee, as well as 885
the price of competing products minus federal and state rebates. 886
The agency may contract with an outside agency or contractor to 887
conduct negotiations for supplemental rebates. For the purposes 888
of this section, the term "supplemental rebates" means cash 889
rebates. Value-added programs as a substitution for supplemental 890
rebates are prohibited. The agency may seek any federal waivers 891
to implement this initiative. 892
8.a. The agency may implement a Medicaid behavioral drug 893
management system. The agency may contract with a vendor tha t 894
has experience in operating behavioral drug management systems 895
to implement this program. The agency may seek federal waivers 896
to implement this program. 897
b. The agency, in conjunction with the Department of 898
Children and Families, may implement the Medic aid behavioral 899
drug management system that is designed to improve the quality 900
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of care and behavioral health prescribing practices based on 901
best practice guidelines, improve patient adherence to 902
medication plans, reduce clinical risk, and lower prescribed 903
drug costs and the rate of inappropriate spending on Medicaid 904
behavioral drugs. The program may include the following 905
elements: 906
(I) Provide for the development and adoption of best 907
practice guidelines for behavioral health -related drugs such as 908
antipsychotics, antidepressants, and medications for treating 909
bipolar disorders and other behavioral conditions; translate 910
them into practice; review behavioral health prescribers and 911
compare their prescribing patterns to a number of indicators 912
that are based on nat ional standards; and determine deviations 913
from best practice guidelines. 914
(II) Implement processes for providing feedback to and 915
educating prescribers using best practice educational materials 916
and peer-to-peer consultation. 917
(III) Assess Medicaid benefic iaries who are outliers in 918
their use of behavioral health drugs with regard to the numbers 919
and types of drugs taken, drug dosages, combination drug 920
therapies, and other indicators of improper use of behavioral 921
health drugs. 922
(IV) Alert prescribers to pati ents who fail to refill 923
prescriptions in a timely fashion, are prescribed multiple same -924
class behavioral health drugs, and may have other potential 925
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medication problems. 926
(V) Track spending trends for behavioral health drugs and 927
deviation from best practic e guidelines. 928
(VI) Use educational and technological approaches to 929
promote best practices, educate consumers, and train prescribers 930
in the use of practice guidelines. 931
(VII) Disseminate electronic and published materials. 932
(VIII) Hold statewide and reg ional conferences. 933
(IX) Implement a disease management program with a model 934
quality-based medication component for severely mentally ill 935
individuals and emotionally disturbed children who are high 936
users of care. 937
9. The agency shall implement a Medicaid prescription drug 938
management system. 939
a. The agency may contract with a vendor that has 940
experience in operating prescription drug management systems in 941
order to implement this system. Any management system that is 942
implemented in accordance with this subp aragraph must rely on 943
cooperation between physicians and pharmacists to determine 944
appropriate practice patterns and clinical guidelines to improve 945
the prescribing, dispensing, and use of drugs in the Medicaid 946
program. The agency may seek federal waivers to implement this 947
program. 948
b. The drug management system must be designed to improve 949
the quality of care and prescribing practices based on best 950
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practice guidelines, improve patient adherence to medication 951
plans, reduce clinical risk, and lower prescribed drug costs and 952
the rate of inappropriate spending on Medicaid prescription 953
drugs. The program must: 954
(I) Provide for the adoption of best practice guidelines 955
for the prescribing and use of drugs in the Medicaid program, 956
including translating best practice guidelines into practice; 957
reviewing prescriber patterns and comparing them to indicators 958
that are based on national standards and practice patterns of 959
clinical peers in their community, statewide, and nationally; 960
and determine deviations from best practic e guidelines. 961
(II) Implement processes for providing feedback to and 962
educating prescribers using best practice educational materials 963
and peer-to-peer consultation. 964
(III) Assess Medicaid recipients who are outliers in their 965
use of a single or multiple p rescription drugs with regard to 966
the numbers and types of drugs taken, drug dosages, combination 967
drug therapies, and other indicators of improper use of 968
prescription drugs. 969
(IV) Alert prescribers to recipients who fail to refill 970
prescriptions in a timely fashion, are prescribed multiple drugs 971
that may be redundant or contraindicated, or may have other 972
potential medication problems. 973
10. The agency may contract for drug rebate 974
administration, including, but not limited to, calculating 975
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rebate amounts, invo icing manufacturers, negotiating disputes 976
with manufacturers, and maintaining a database of rebate 977
collections. 978
11. The agency may specify the preferred daily dosing form 979
or strength for the purpose of promoting best practices with 980
regard to the prescrib ing of certain drugs as specified in the 981
General Appropriations Act and ensuring cost -effective 982
prescribing practices. 983
12. The agency may require prior authorization for 984
Medicaid-covered prescribed drugs. The agency may prior -985
authorize the use of a produ ct: 986
a. For an indication not approved in labeling; 987
b. To comply with certain clinical guidelines; or 988
c. If the product has the potential for overuse, misuse, 989
or abuse. 990
991
The agency may require the prescribing professional to provide 992
information about the rationale and supporting medical evidence 993
for the use of a drug. The agency shall post prior 994
authorization, step-edit criteria and protocol, and updates to 995
the list of drugs that are subject to prior authorization on the 996
agency's Internet website within 21 days after the prior 997
authorization and step -edit criteria and protocol and updates 998
are approved by the agency. For purposes of this subparagraph, 999
the term "step-edit" means an automatic electronic review of 1000
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certain medications subject to prior authorization. 1001
13. The agency, in conjunction with the Pharmaceutical and 1002
Therapeutics Committee, may require age -related prior 1003
authorizations for certain prescribed drugs. The age ncy may 1004
preauthorize the use of a drug for a recipient who may not meet 1005
the age requirement or may exceed the length of therapy for use 1006
of this product as recommended by the manufacturer and approved 1007
by the Food and Drug Administration. Prior authorization may 1008
require the prescribing professional to provide information 1009
about the rationale and supporting medical evidence for the use 1010
of a drug. 1011
14. The agency shall implement a step -therapy prior 1012
authorization approval process for medications excluded from t he 1013
preferred drug list. Medications listed on the preferred drug 1014
list must be used within the previous 12 months before the 1015
alternative medications that are not listed. The step -therapy 1016
prior authorization may require the prescriber to use the 1017
medications of a similar drug class or for a similar medical 1018
indication unless contraindicated in the Food and Drug 1019
Administration labeling. The trial period between the specified 1020
steps may vary according to the medical indication. The step -1021
therapy approval process sh all be developed in accordance with 1022
the committee as stated in s. 409.91195(7) and (8). A drug 1023
product may be approved without meeting the step -therapy prior 1024
authorization criteria if the prescribing physician provides the 1025
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agency with additional written me dical or clinical documentation 1026
that the product is medically necessary because: 1027
a. There is not a drug on the preferred drug list to treat 1028
the disease or medical condition which is an acceptable clinical 1029
alternative; 1030
b. The alternatives have been inef fective in the treatment 1031
of the beneficiary's disease; or 1032
c. Based on historic evidence and known characteristics of 1033
the patient and the drug, the drug is likely to be ineffective, 1034
or the number of doses have been ineffective. 1035
1036
The agency shall work with the physician to determine the best 1037
alternative for the patient. The agency may adopt rules waiving 1038
the requirements for written clinical documentation for specific 1039
drugs in limited clinical situations. 1040
15. The agency shall implement a return and reuse program 1041
for drugs dispensed by pharmacies to institutional recipients, 1042
which includes payment of a $5 restocking fee for the 1043
implementation and operation of the program. The return and 1044
reuse program shall be implemented electronically and in a 1045
manner that promotes efficiency. The program must permit a 1046
pharmacy to exclude drugs from the program if it is not 1047
practical or cost-effective for the drug to be included and must 1048
provide for the return to inventory of drugs that cannot be 1049
credited or returned in a co st-effective manner. The agency 1050
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shall determine if the program has reduced the amount of 1051
Medicaid prescription drugs which are destroyed on an annual 1052
basis and if there are additional ways to ensure more 1053
prescription drugs are not destroyed which could saf ely be 1054
reused. 1055
Section 15. Subsection (9) of section 499.067, Florida 1056
Statutes, is amended to read: 1057
499.067 Denial, suspension, or revocation of permit, 1058
certification, or registration. — 1059
(9)(a) The department may deny, suspend, or revoke a 1060
permit under this part if it finds the permittee has not 1061
complied with the reporting requirements of, or knowingly made a 1062
false statement in a report required by, s. 499.0121(14). 1063
(b) The department may deny an application for a renewal 1064
permit or suspend or revok e a permit if it finds the permittee 1065
has not complied with the reporting requirements of, or 1066
knowingly made a false statement in a report required by, s. 1067
499.0121(16). 1068
(c) The department may deny an application for a renewal 1069
permit or suspend or revoke a permit if it finds the permittee 1070
has not complied with the notification or reporting requirements 1071
of, or knowingly made a false statement in a notice or report 1072
required by, s. 499.026(2) or (3), respectively. 1073
Section 16. This act shall take effect July 1, 2022. 1074