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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 step-therapy protocols; amending s. 2
409.901, F.S.; defining the term "serious mental 3
illness"; amending s. 409.912, F.S.; requiring the 4
Agency for Health Care Administration to approve drug 5
products for Medicaid recipients for the treatment of 6
serious mental illness without step -therapy prior 7
authorization under certain circumstances; amending s. 8
409.910, F.S.; conforming a cross -reference; directing 9
the agency to include rate impacts resulting from the 10
act in certain rates that become effective on a 11
specified date; providing effective dates. 12
13
Be It Enacted by the Legislature of the State of Florida: 14
15
Section 1. Present subsections (27) and (28) of section 16
409.901, Florida Statutes, are redesignated as subsections (28) 17
and (29), respectively, and a new subsection (27) is added to 18
that section, to read: 19
409.901 Definitions; ss. 409.901 -409.920.—As used in ss. 20
409.901-409.920, except as otherwise specifically provided, the 21
term: 22
(27) "Serious mental illness" means any of the following 23
psychiatric disorders as defined by the American Psychiatric 24
Association in the Diagnostic and Statistical Manual of Mental 25
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Disorders, Fifth Edition: 26
(a) Bipolar disorders, including hypomanic, manic, 27
depressive, and mixed -feature episodes. 28
(b) Depression in childhood or adolescence. 29
(c) Major depressive disorders, including single and 30
recurrent depressive episodes. 31
(d) Obsessive-compulsive disorders. 32
(e) Paranoid personality disorder or other psychotic 33
disorders. 34
(f) Schizoaffective disorders, including bipolar or 35
depressive symptoms. 36
(g) Schizophrenia. 37
Section 2. Paragraph (a) of subsection (5) of section 38
409.912, Florida Statutes, is ame nded to read: 39
409.912 Cost-effective purchasing of health care. —The 40
agency shall purchase goods and services for Medicaid recipients 41
in the most cost-effective manner consistent with the delivery 42
of quality medical care. To ensure that medical services a re 43
effectively utilized, the agency may, in any case, require a 44
confirmation or second physician's opinion of the correct 45
diagnosis for purposes of authorizing future services under the 46
Medicaid program. This section does not restrict access to 47
emergency services or poststabilization care services as defined 48
in 42 C.F.R. s. 438.114. Such confirmation or second opinion 49
shall be rendered in a manner approved by the agency. The agency 50
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shall maximize the use of prepaid per capita and prepaid 51
aggregate fixed-sum basis services when appropriate and other 52
alternative service delivery and reimbursement methodologies, 53
including competitive bidding pursuant to s. 287.057, designed 54
to facilitate the cost -effective purchase of a case -managed 55
continuum of care. The agenc y shall also require providers to 56
minimize the exposure of recipients to the need for acute 57
inpatient, custodial, and other institutional care and the 58
inappropriate or unnecessary use of high -cost services. The 59
agency shall contract with a vendor to monito r and evaluate the 60
clinical practice patterns of providers in order to identify 61
trends that are outside the normal practice patterns of a 62
provider's professional peers or the national guidelines of a 63
provider's professional association. The vendor must be able to 64
provide information and counseling to a provider whose practice 65
patterns are outside the norms, in consultation with the agency, 66
to improve patient care and reduce inappropriate utilization. 67
The agency may mandate prior authorization, drug therapy 68
management, or disease management participation for certain 69
populations of Medicaid beneficiaries, certain drug classes, or 70
particular drugs to prevent fraud, abuse, overuse, and possible 71
dangerous drug interactions. The Pharmaceutical and Therapeutics 72
Committee shall make recommendations to the agency on drugs for 73
which prior authorization is required. The agency shall inform 74
the Pharmaceutical and Therapeutics Committee of its decisions 75
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regarding drugs subject to prior authorization. The agency is 76
authorized to limit the entities it contracts with or enrolls as 77
Medicaid providers by developing a provider network through 78
provider credentialing. The agency may competitively bid single -79
source-provider contracts if procurement of goods or services 80
results in demonstrated cost savings to the state without 81
limiting access to care. The agency may limit its network based 82
on the assessment of beneficiary access to care, provider 83
availability, provider quality standards, time and distance 84
standards for access to care , the cultural competence of the 85
provider network, demographic characteristics of Medicaid 86
beneficiaries, practice and provider -to-beneficiary standards, 87
appointment wait times, beneficiary use of services, provider 88
turnover, provider profiling, provider l icensure history, 89
previous program integrity investigations and findings, peer 90
review, provider Medicaid policy and billing compliance records, 91
clinical and medical record audits, and other factors. Providers 92
are not entitled to enrollment in the Medicaid provider network. 93
The agency shall determine instances in which allowing Medicaid 94
beneficiaries to purchase durable medical equipment and other 95
goods is less expensive to the Medicaid program than long -term 96
rental of the equipment or goods. The agency may establish rules 97
to facilitate purchases in lieu of long -term rentals in order to 98
protect against fraud and abuse in the Medicaid program as 99
defined in s. 409.913. The agency may seek federal waivers 100
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necessary to administer these policies. 101
(5)(a) The agency shall implement a Medicaid prescribed -102
drug spending-control program that includes the following 103
components: 104
1. A Medicaid preferred drug list, which shall be a 105
listing of cost-effective therapeutic options recommended by the 106
Medicaid Pharmacy and Therapeutics Committee established 107
pursuant to s. 409.91195 and adopted by the agency for each 108
therapeutic class on the preferred drug list. At the discretion 109
of the committee, and when feasible, the preferred drug list 110
should include at least two products in a therapeutic class. The 111
agency may post the preferred drug list and updates to the list 112
on an Internet website without following the rulemaking 113
procedures of chapter 120. Antiretroviral agents are excluded 114
from the preferred drug list. The agency shal l also limit the 115
amount of a prescribed drug dispensed to no more than a 34 -day 116
supply unless the drug products' smallest marketed package is 117
greater than a 34-day supply, or the drug is determined by the 118
agency to be a maintenance drug , in which case a 100-day maximum 119
supply may be authorized. The agency may seek any federal 120
waivers necessary to implement these cost -control programs and 121
to continue participation in the federal Medicaid rebate 122
program, or alternatively to negotiate state -only manufacturer 123
rebates. The agency may adopt rules to administer this 124
subparagraph. The agency shall continue to provide unlimited 125
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contraceptive drugs and items. The agency must establish 126
procedures to ensure that: 127
a. There is a response to a request for prior 128
authorization by telephone or other telecommunication device 129
within 24 hours after receipt of a request for prior 130
authorization; and 131
b. A 72-hour supply of the drug prescribed is provided in 132
an emergency or when the agency does not provide a response 133
within 24 hours as required by sub -subparagraph a. 134
2. A provider of prescribed drugs is reimbursed in an 135
amount not to exceed the lesser of the actual acquisition cost 136
based on the Centers for Medicare and Medicaid Services National 137
Average Drug Acquisition Cost pri cing files plus a professional 138
dispensing fee, the wholesale acquisition cost plus a 139
professional dispensing fee, the state maximum allowable cost 140
plus a professional dispensing fee, or the usual and customary 141
charge billed by the provider. 142
3. The agency shall develop and implement a process for 143
managing the drug therapies of Medicaid recipients who are using 144
significant numbers of prescribed drugs each month. The 145
management process may include, but is not limited to, 146
comprehensive, physician -directed medical-record reviews, claims 147
analyses, and case evaluations to determine the medical 148
necessity and appropriateness of a patient's treatment plan and 149
drug therapies. The agency may contract with a private 150
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organization to provide drug -program-management services. The 151
Medicaid drug benefit management program shall include 152
initiatives to manage drug therapies for HIV/AIDS patients, 153
patients using 20 or more unique prescriptions in a 180 -day 154
period, and the top 1,000 patients in annual spending. The 155
agency must shall enroll any Medicaid recipient in the drug 156
benefit management program if he or she meets the specifications 157
of this provision and is not enrolled in a Medicaid health 158
maintenance organization. 159
4. The agency may limit the size of its pharmacy network 160
based on need, competitive bidding, price negotiations, 161
credentialing, or similar criteria. The agency shall give 162
special consideration to rural areas in determining the size and 163
location of pharmacies included in the Medicaid pharmacy 164
network. A pharmacy credentialing process may include criteria 165
such as a pharmacy's full -service status, location, size, 166
patient educational programs, patient consultation, disease 167
management services, and other characteristics. The agency may 168
impose a moratorium on Medicaid pharmacy enrollment if it is 169
determined that it has a sufficient number of Medicaid -170
participating providers. The agency must allow dispensing 171
practitioners to participate as a part of the Medicaid pharmacy 172
network regardless of the practitioner's proximity to any other 173
entity that is dispensing prescription drugs under the Medicaid 174
program. A dispensing practitioner must meet all credentialing 175
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requirements applicable to his or her practice, as determined by 176
the agency. 177
5. The agency shall develop and impl ement a program that 178
requires Medicaid practitioners who issue written prescriptions 179
for medicinal drugs to use a counterfeit -proof prescription pad 180
for Medicaid prescriptions. The agency shall require the use of 181
standardized counterfeit -proof prescription pads by prescribers 182
who issue written prescriptions for Medicaid recipients. The 183
agency may implement the program in targeted geographic areas or 184
statewide. 185
6. The agency may enter into arrangements that require 186
manufacturers of generic drugs prescribed to Medicaid recipients 187
to provide rebates of at least 15.1 percent of the average 188
manufacturer price for the manufacturer's generic products. 189
These arrangements must shall require that if a generic -drug 190
manufacturer pays federal rebates for Medicaid -reimbursed drugs 191
at a level below 15.1 percent, the manufacturer must provide a 192
supplemental rebate to the state in an amount necessary to 193
achieve a 15.1-percent rebate level. 194
7. The agency may establish a preferred drug list as 195
described in this subsection, and, pursuant to the establishment 196
of such preferred drug list, negotiate supplemental rebates from 197
manufacturers that are in addition to those required by Title 198
XIX of the Social Security Act and at no less than 14 percent of 199
the average manufacturer pric e as defined in 42 U.S.C. s. 1936 200
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on the last day of a quarter unless the federal or supplemental 201
rebate, or both, equals or exceeds 29 percent. There is no upper 202
limit on the supplemental rebates the agency may negotiate. The 203
agency may determine that spe cific products, brand -name or 204
generic, are competitive at lower rebate percentages. Agreement 205
to pay the minimum supplemental rebate percentage guarantees a 206
manufacturer that the Medicaid Pharmaceutical and Therapeutics 207
Committee will consider a product fo r inclusion on the preferred 208
drug list. However, a pharmaceutical manufacturer is not 209
guaranteed placement on the preferred drug list by simply paying 210
the minimum supplemental rebate. Agency decisions will be made 211
on the clinical efficacy of a drug and rec ommendations of the 212
Medicaid Pharmaceutical and Therapeutics Committee, as well as 213
the price of competing products minus federal and state rebates. 214
The agency may contract with an outside agency or contractor to 215
conduct negotiations for supplemental rebate s. For the purposes 216
of this section, the term "supplemental rebates" means cash 217
rebates. Value-added programs as a substitution for supplemental 218
rebates are prohibited. The agency may seek any federal waivers 219
to implement this initiative. 220
8.a. The agency may implement a Medicaid behavioral drug 221
management system. The agency may contract with a vendor that 222
has experience in operating behavioral drug management systems 223
to implement this program. The agency may seek federal waivers 224
to implement this program. 225
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b. The agency, in conjunction with the Department of 226
Children and Families, may implement the Medicaid behavioral 227
drug management system that is designed to improve the quality 228
of care and behavioral health prescribing practices based on 229
best practice guidelines, improve patient adherence to 230
medication plans, reduce clinical risk, and lower prescribed 231
drug costs and the rate of inappropriate spending on Medicaid 232
behavioral drugs. The program may include the following 233
elements: 234
(I) Provide for the devel opment and adoption of best 235
practice guidelines for behavioral health -related drugs such as 236
antipsychotics, antidepressants, and medications for treating 237
bipolar disorders and other behavioral conditions; translate 238
them into practice; review behavioral hea lth prescribers and 239
compare their prescribing patterns to a number of indicators 240
that are based on national standards; and determine deviations 241
from best practice guidelines. 242
(II) Implement processes for providing feedback to and 243
educating prescribers us ing best practice educational materials 244
and peer-to-peer consultation. 245
(III) Assess Medicaid beneficiaries who are outliers in 246
their use of behavioral health drugs with regard to the numbers 247
and types of drugs taken, drug dosages, combination drug 248
therapies, and other indicators of improper use of behavioral 249
health drugs. 250
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(IV) Alert prescribers to patients who fail to refill 251
prescriptions in a timely fashion, are prescribed multiple same -252
class behavioral health drugs, and may have other potential 253
medication problems. 254
(V) Track spending trends for behavioral health drugs and 255
deviation from best practice guidelines. 256
(VI) Use educational and technological approaches to 257
promote best practices, educate consumers, and train prescribers 258
in the use of practi ce guidelines. 259
(VII) Disseminate electronic and published materials. 260
(VIII) Hold statewide and regional conferences. 261
(IX) Implement a disease management program with a model 262
quality-based medication component for severely mentally ill 263
individuals and emotionally disturbed children who are high 264
users of care. 265
9. The agency shall implement a Medicaid prescription drug 266
management system. 267
a. The agency may contract with a vendor that has 268
experience in operating prescription drug management systems in 269
order to implement this system. Any management system that is 270
implemented in accordance with this subparagraph must rely on 271
cooperation between physicians and pharmacists to determine 272
appropriate practice patterns and clinical guidelines to improve 273
the prescribing, dispensing, and use of drugs in the Medicaid 274
program. The agency may seek federal waivers to implement this 275
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program. 276
b. The drug management system must be designed to improve 277
the quality of care and prescribing practices based on best 278
practice guidelines, improve patient adherence to medication 279
plans, reduce clinical risk, and lower prescribed drug costs and 280
the rate of inappropriate spending on Medicaid prescription 281
drugs. The program must: 282
(I) Provide for the adoption of best practice guidel ines 283
for the prescribing and use of drugs in the Medicaid program, 284
including translating best practice guidelines into practice; 285
reviewing prescriber patterns and comparing them to indicators 286
that are based on national standards and practice patterns of 287
clinical peers in their community, statewide, and nationally; 288
and determine deviations from best practice guidelines. 289
(II) Implement processes for providing feedback to and 290
educating prescribers using best practice educational materials 291
and peer-to-peer consultation. 292
(III) Assess Medicaid recipients who are outliers in their 293
use of a single or multiple prescription drugs with regard to 294
the numbers and types of drugs taken, drug dosages, combination 295
drug therapies, and other indicators of improper use of 296
prescription drugs. 297
(IV) Alert prescribers to recipients who fail to refill 298
prescriptions in a timely fashion, are prescribed multiple drugs 299
that may be redundant or contraindicated, or may have other 300
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potential medication problems. 301
10. The agency may co ntract for drug rebate 302
administration, including, but not limited to, calculating 303
rebate amounts, invoicing manufacturers, negotiating disputes 304
with manufacturers, and maintaining a database of rebate 305
collections. 306
11. The agency may specify the preferred daily dosing form 307
or strength for the purpose of promoting best practices with 308
regard to the prescribing of certain drugs as specified in the 309
General Appropriations Act and ensuring cost -effective 310
prescribing practices. 311
12. The agency may require prior authorization for 312
Medicaid-covered prescribed drugs. The agency may prior -313
authorize the use of a product: 314
a. For an indication not approved in labeling; 315
b. To comply with certain clinical guidelines; or 316
c. If the product has the potential for overuse , misuse, 317
or abuse. 318
319
The agency may require the prescribing professional to provide 320
information about the rationale and supporting medical evidence 321
for the use of a drug. The agency shall post prior 322
authorization, step-edit criteria and protocol, and updat es to 323
the list of drugs that are subject to prior authorization on the 324
agency's Internet website within 21 days after the prior 325
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authorization and step -edit criteria and protocol and updates 326
are approved by the agency. For purposes of this subparagraph, 327
the term "step-edit" means an automatic electronic review of 328
certain medications subject to prior authorization. 329
13. The agency, in conjunction with the Pharmaceutical and 330
Therapeutics Committee, may require age -related prior 331
authorizations for certain pres cribed drugs. The agency may 332
preauthorize the use of a drug for a recipient who may not meet 333
the age requirement or may exceed the length of therapy for use 334
of this product as recommended by the manufacturer and approved 335
by the Food and Drug Administration . Prior authorization may 336
require the prescribing professional to provide information 337
about the rationale and supporting medical evidence for the use 338
of a drug. 339
14. The agency shall implement a step -therapy prior 340
authorization approval process for medica tions excluded from the 341
preferred drug list. Medications listed on the preferred drug 342
list must be used within the previous 12 months before the 343
alternative medications that are not listed. The step -therapy 344
prior authorization may require the prescriber to use the 345
medications of a similar drug class or for a similar medical 346
indication unless contraindicated in the Food and Drug 347
Administration labeling. The trial period between the specified 348
steps may vary according to the medical indication. The step -349
therapy approval process must shall be developed in accordance 350
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with the committee as stated in s. 409.91195(7) and (8). A drug 351
product may be approved or, in the case of a drug product for 352
the treatment of a serious mental illness, must be approved 353
without meeting the step-therapy prior authorization criteria if 354
the prescribing physician provides the agency with additional 355
written medical or clinical documentation that the product is 356
medically necessary because: 357
a. There is not a drug on the preferred drug list to treat 358
the disease or medical condition which is an acceptable clinical 359
alternative; 360
b. The alternatives have been ineffective in the treatment 361
of the beneficiary's disease; 362
c. The drug product or medication of a similar drug class 363
is prescribed for the treatment of a serious mental illness 364
schizophrenia or schizotypal or delusional disorders ; prior 365
authorization has been granted previously for the prescribed 366
drug; and the medication was dispensed to the patient during the 367
previous 12 months; or 368
d. Based on historical evidence and known characteristics 369
of the patient and the drug, the drug is likely to be 370
ineffective, or the number of doses have been ineffective. 371
372
The agency shall work with the physician to determine the best 373
alternative for the pat ient. The agency may adopt rules waiving 374
the requirements for written clinical documentation for specific 375
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drugs in limited clinical situations. 376
15. The agency shall implement a return and reuse program 377
for drugs dispensed by pharmacies to institutional r ecipients, 378
which includes payment of a $5 restocking fee for the 379
implementation and operation of the program. The return and 380
reuse program must shall be implemented electronically and in a 381
manner that promotes efficiency. The program must permit a 382
pharmacy to exclude drugs from the program if it is not 383
practical or cost-effective for the drug to be included and must 384
provide for the return to inventory of drugs that cannot be 385
credited or returned in a cost -effective manner. The agency 386
shall determine whether if the program has reduced the amount of 387
Medicaid prescription drugs which are destroyed on an annual 388
basis and whether if there are additional ways to ensure more 389
prescription drugs are not destroyed which could safely be 390
reused. 391
Section 3. Paragraph (a) of subsection (20) of section 392
409.910, Florida Statutes, is amended to read: 393
409.910 Responsibility for payments on behalf of Medicaid -394
eligible persons when other parties are liable. — 395
(20)(a) Entities providing health insurance as defined in 396
s. 624.603, health maintenance organizations and prepaid health 397
clinics as defined in chapter 641, and, on behalf of their 398
clients, third-party administrators, pharmacy benefits managers, 399
and any other third parties, as defined in s. 409.901(28) s. 400
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409.901(27), which are legally responsible for payment of a 401
claim for a health care item or service as a condition of doing 402
business in this the state or providing coverage to residents of 403
this state, shall provide such records and information as are 404
necessary to accomplish the purpose of this section, unless such 405
requirement results in an unreasonable burden. 406
Section 4. The Agency for Health Care Administration is 407
directed to include the rate impact of this act in the Medicaid 408
managed medical assistance program and long-term care managed 409
care program rates that become effective on October 1, 2025. 410
This section shall take effect upon this act becoming a law. 411
Section 5. Except as otherwise expressly provided in this 412
act and except for this section, which shall take effect upon 413
this act becoming a law, this act shall take effect October 1, 414
2025. 415