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A bill to be entitled 1
An act relating to Medicaid step -therapy protocols for 2
drugs for serious mental illness treatments; amending 3
s. 409.901, F.S.; defining the term "serious mental 4
illness"; amending s. 409.912, F.S.; requiring the 5
Agency for Health Care Administration to approve drug 6
products for Medicaid recipients for the treatment of 7
serious mental illness without step -therapy prior 8
authorization under certain circumstances; amen ding s. 9
409.910, F.S.; conforming a cross -reference; providing 10
an effective date. 11
12
Be It Enacted by the Legislature of the State of Florida: 13
14
Section 1. Present subsections (27) and (28) of section 15
409.901, Florida Statutes, are redesignated as s ubsections (28) 16
and (29), respectively, and a new subsection (27) is added to 17
that section, to read: 18
409.901 Definitions; ss. 409.901 -409.920.—As used in ss. 19
409.901-409.920, except as otherwise specifically provided, the 20
term: 21
(27) "Serious mental ill ness" means any of the following 22
psychiatric disorders as defined by the American Psychiatric 23
Association in the Diagnostic and Statistical Manual of Mental 24
Disorders, Fifth Edition: 25
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(a) Bipolar disorders, including hypomanic, manic, 26
depressive, and mixe d-feature episodes. 27
(b) Depression in childhood or adolescence. 28
(c) Major depressive disorders, including single and 29
recurrent depressive episodes. 30
(d) Obsessive-compulsive disorders. 31
(e) Paranoid personality disorder or other psychotic 32
disorders. 33
(f) Schizoaffective disorders, including bipolar or 34
depressive symptoms. 35
(g) Schizophrenia. 36
Section 2. Paragraph (a) of subsection (5) of section 37
409.912, Florida Statutes, is amended to read: 38
409.912 Cost-effective purchasing of health care. —The 39
agency shall purchase goods and services for Medicaid recipients 40
in the most cost-effective manner consistent with the delivery 41
of quality medical care. To ensure that medical services are 42
effectively utilized, the agency may, in any case, require a 43
confirmation or second physician's opinion of the correct 44
diagnosis for purposes of authorizing future services under the 45
Medicaid program. This section does not restrict access to 46
emergency services or poststabilization care services as defined 47
in 42 C.F.R. s. 438.114. Such confirmation or second opinion 48
shall be rendered in a manner approved by the agency. The agency 49
shall maximize the use of prepaid per capita and prepaid 50
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aggregate fixed-sum basis services when appropriate and other 51
alternative service delive ry and reimbursement methodologies, 52
including competitive bidding pursuant to s. 287.057, designed 53
to facilitate the cost -effective purchase of a case -managed 54
continuum of care. The agency shall also require providers to 55
minimize the exposure of recipients to the need for acute 56
inpatient, custodial, and other institutional care and the 57
inappropriate or unnecessary use of high -cost services. The 58
agency shall contract with a vendor to monitor and evaluate the 59
clinical practice patterns of providers in order t o identify 60
trends that are outside the normal practice patterns of a 61
provider's professional peers or the national guidelines of a 62
provider's professional association. The vendor must be able to 63
provide information and counseling to a provider whose practi ce 64
patterns are outside the norms, in consultation with the agency, 65
to improve patient care and reduce inappropriate utilization. 66
The agency may mandate prior authorization, drug therapy 67
management, or disease management participation for certain 68
populations of Medicaid beneficiaries, certain drug classes, or 69
particular drugs to prevent fraud, abuse, overuse, and possible 70
dangerous drug interactions. The Pharmaceutical and Therapeutics 71
Committee shall make recommendations to the agency on drugs for 72
which prior authorization is required. The agency shall inform 73
the Pharmaceutical and Therapeutics Committee of its decisions 74
regarding drugs subject to prior authorization. The agency is 75
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authorized to limit the entities it contracts with or enrolls as 76
Medicaid providers by developing a provider network through 77
provider credentialing. The agency may competitively bid single -78
source-provider contracts if procurement of goods or services 79
results in demonstrated cost savings to the state without 80
limiting access to care . The agency may limit its network based 81
on the assessment of beneficiary access to care, provider 82
availability, provider quality standards, time and distance 83
standards for access to care, the cultural competence of the 84
provider network, demographic charac teristics of Medicaid 85
beneficiaries, practice and provider -to-beneficiary standards, 86
appointment wait times, beneficiary use of services, provider 87
turnover, provider profiling, provider licensure history, 88
previous program integrity investigations and findi ngs, peer 89
review, provider Medicaid policy and billing compliance records, 90
clinical and medical record audits, and other factors. Providers 91
are not entitled to enrollment in the Medicaid provider network. 92
The agency shall determine instances in which allow ing Medicaid 93
beneficiaries to purchase durable medical equipment and other 94
goods is less expensive to the Medicaid program than long -term 95
rental of the equipment or goods. The agency may establish rules 96
to facilitate purchases in lieu of long -term rentals in order to 97
protect against fraud and abuse in the Medicaid program as 98
defined in s. 409.913. The agency may seek federal waivers 99
necessary to administer these policies. 100
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(5)(a) The agency shall implement a Medicaid prescribed -101
drug spending-control program that includes the following 102
components: 103
1. A Medicaid preferred drug list, which shall be a 104
listing of cost-effective therapeutic options recommended by the 105
Medicaid Pharmacy and Therapeutics Committee established 106
pursuant to s. 409.91195 and adopted by the agency for each 107
therapeutic class on the preferred drug list. At the discretion 108
of the committee, and when feasible, the preferred drug list 109
should include at least two products in a therapeutic class. The 110
agency may post the preferred drug list and updates to the list 111
on an Internet website without following the rulemaking 112
procedures of chapter 120. Antiretroviral agents are excluded 113
from the preferred drug list. The agency shall also limit the 114
amount of a prescribed drug dispensed to no more than a 34 -day 115
supply unless the drug products' sma llest marketed package is 116
greater than a 34-day supply, or the drug is determined by the 117
agency to be a maintenance drug in which case a 100 -day maximum 118
supply may be authorized. The agency may seek any federal 119
waivers necessary to implement these cost -control programs and 120
to continue participation in the federal Medicaid rebate 121
program, or alternatively to negotiate state -only manufacturer 122
rebates. The agency may adopt rules to administer this 123
subparagraph. The agency shall continue to provide unlimited 124
contraceptive drugs and items. The agency must establish 125
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procedures to ensure that: 126
a. There is a response to a request for prior 127
authorization by telephone or other telecommunication device 128
within 24 hours after receipt of a request for prior 129
authorization; and 130
b. A 72-hour supply of the drug prescribed is provided in 131
an emergency or when the agency does not provide a response 132
within 24 hours as required by sub -subparagraph a. 133
2. A provider of prescribed drugs is reimbursed in an 134
amount not to exceed t he lesser of the actual acquisition cost 135
based on the Centers for Medicare and Medicaid Services National 136
Average Drug Acquisition Cost pricing files plus a professional 137
dispensing fee, the wholesale acquisition cost plus a 138
professional dispensing fee, the state maximum allowable cost 139
plus a professional dispensing fee, or the usual and customary 140
charge billed by the provider. 141
3. The agency shall develop and implement a process for 142
managing the drug therapies of Medicaid recipients who are using 143
significant numbers of prescribed drugs each month. The 144
management process may include, but is not limited to, 145
comprehensive, physician -directed medical-record reviews, claims 146
analyses, and case evaluations to determine the medical 147
necessity and appropriateness of a patient's treatment plan and 148
drug therapies. The agency may contract with a private 149
organization to provide drug -program-management services. The 150
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Medicaid drug benefit management program shall include 151
initiatives to manage drug therapies for HIV/AIDS pat ients, 152
patients using 20 or more unique prescriptions in a 180 -day 153
period, and the top 1,000 patients in annual spending. The 154
agency shall enroll any Medicaid recipient in the drug benefit 155
management program if he or she meets the specifications of this 156
provision and is not enrolled in a Medicaid health maintenance 157
organization. 158
4. The agency may limit the size of its pharmacy network 159
based on need, competitive bidding, price negotiations, 160
credentialing, or similar criteria. The agency shall give 161
special consideration to rural areas in determining the size and 162
location of pharmacies included in the Medicaid pharmacy 163
network. A pharmacy credentialing process may include criteria 164
such as a pharmacy's full -service status, location, size, 165
patient educational p rograms, patient consultation, disease 166
management services, and other characteristics. The agency may 167
impose a moratorium on Medicaid pharmacy enrollment if it is 168
determined that it has a sufficient number of Medicaid -169
participating providers. The agency mu st allow dispensing 170
practitioners to participate as a part of the Medicaid pharmacy 171
network regardless of the practitioner's proximity to any other 172
entity that is dispensing prescription drugs under the Medicaid 173
program. A dispensing practitioner must meet all credentialing 174
requirements applicable to his or her practice, as determined by 175
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the agency. 176
5. The agency shall develop and implement a program that 177
requires Medicaid practitioners who issue written prescriptions 178
for medicinal drugs to use a counterf eit-proof prescription pad 179
for Medicaid prescriptions. The agency shall require the use of 180
standardized counterfeit -proof prescription pads by prescribers 181
who issue written prescriptions for Medicaid recipients. The 182
agency may implement the program in targ eted geographic areas or 183
statewide. 184
6. The agency may enter into arrangements that require 185
manufacturers of generic drugs prescribed to Medicaid recipients 186
to provide rebates of at least 15.1 percent of the average 187
manufacturer price for the manufacturer 's generic products. 188
These arrangements must shall require that if a generic -drug 189
manufacturer pays federal rebates for Medicaid -reimbursed drugs 190
at a level below 15.1 percent, the manufacturer must provide a 191
supplemental rebate to the state in an amount n ecessary to 192
achieve a 15.1-percent rebate level. 193
7. The agency may establish a preferred drug list as 194
described in this subsection, and, pursuant to the establishment 195
of such preferred drug list, negotiate supplemental rebates from 196
manufacturers that are in addition to those required by Title 197
XIX of the Social Security Act and at no less than 14 percent of 198
the average manufacturer price as defined in 42 U.S.C. s. 1936 199
on the last day of a quarter unless the federal or supplemental 200
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rebate, or both, equals or exceeds 29 percent. There is no upper 201
limit on the supplemental rebates the agency may negotiate. The 202
agency may determine that specific products, brand -name or 203
generic, are competitive at lower rebate percentages. Agreement 204
to pay the minimum supplemen tal rebate percentage guarantees a 205
manufacturer that the Medicaid Pharmaceutical and Therapeutics 206
Committee will consider a product for inclusion on the preferred 207
drug list. However, a pharmaceutical manufacturer is not 208
guaranteed placement on the preferre d drug list by simply paying 209
the minimum supplemental rebate. Agency decisions will be made 210
on the clinical efficacy of a drug and recommendations of the 211
Medicaid Pharmaceutical and Therapeutics Committee, as well as 212
the price of competing products minus f ederal and state rebates. 213
The agency may contract with an outside agency or contractor to 214
conduct negotiations for supplemental rebates. For the purposes 215
of this section, the term "supplemental rebates" means cash 216
rebates. Value-added programs as a substit ution for supplemental 217
rebates are prohibited. The agency may seek any federal waivers 218
to implement this initiative. 219
8.a. The agency may implement a Medicaid behavioral drug 220
management system. The agency may contract with a vendor that 221
has experience in operating behavioral drug management systems 222
to implement this program. The agency may seek federal waivers 223
to implement this program. 224
b. The agency, in conjunction with the Department of 225
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Children and Families, may implement the Medicaid behavioral 226
drug management system that is designed to improve the quality 227
of care and behavioral health prescribing practices based on 228
best practice guidelines, improve patient adherence to 229
medication plans, reduce clinical risk, and lower prescribed 230
drug costs and the ra te of inappropriate spending on Medicaid 231
behavioral drugs. The program may include the following 232
elements: 233
(I) Provide for the development and adoption of best 234
practice guidelines for behavioral health -related drugs such as 235
antipsychotics, antidepressant s, and medications for treating 236
bipolar disorders and other behavioral conditions; translate 237
them into practice; review behavioral health prescribers and 238
compare their prescribing patterns to a number of indicators 239
that are based on national standards; and determine deviations 240
from best practice guidelines. 241
(II) Implement processes for providing feedback to and 242
educating prescribers using best practice educational materials 243
and peer-to-peer consultation. 244
(III) Assess Medicaid beneficiaries who are outli ers in 245
their use of behavioral health drugs with regard to the numbers 246
and types of drugs taken, drug dosages, combination drug 247
therapies, and other indicators of improper use of behavioral 248
health drugs. 249
(IV) Alert prescribers to patients who fail to ref ill 250
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prescriptions in a timely fashion, are prescribed multiple same -251
class behavioral health drugs, and may have other potential 252
medication problems. 253
(V) Track spending trends for behavioral health drugs and 254
deviation from best practice guidelines. 255
(VI) Use educational and technological approaches to 256
promote best practices, educate consumers, and train prescribers 257
in the use of practice guidelines. 258
(VII) Disseminate electronic and published materials. 259
(VIII) Hold statewide and regional conferences. 260
(IX) Implement a disease management program with a model 261
quality-based medication component for severely mentally ill 262
individuals and emotionally disturbed children who are high 263
users of care. 264
9. The agency shall implement a Medicaid prescription drug 265
management system. 266
a. The agency may contract with a vendor that has 267
experience in operating prescription drug management systems in 268
order to implement this system. Any management system that is 269
implemented in accordance with this subparagraph must rely o n 270
cooperation between physicians and pharmacists to determine 271
appropriate practice patterns and clinical guidelines to improve 272
the prescribing, dispensing, and use of drugs in the Medicaid 273
program. The agency may seek federal waivers to implement this 274
program. 275
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b. The drug management system must be designed to improve 276
the quality of care and prescribing practices based on best 277
practice guidelines, improve patient adherence to medication 278
plans, reduce clinical risk, and lower prescribed drug costs and 279
the rate of inappropriate spending on Medicaid prescription 280
drugs. The program must: 281
(I) Provide for the adoption of best practice guidelines 282
for the prescribing and use of drugs in the Medicaid program, 283
including translating best practice guidelines into pra ctice; 284
reviewing prescriber patterns and comparing them to indicators 285
that are based on national standards and practice patterns of 286
clinical peers in their community, statewide, and nationally; 287
and determine deviations from best practice guidelines. 288
(II) Implement processes for providing feedback to and 289
educating prescribers using best practice educational materials 290
and peer-to-peer consultation. 291
(III) Assess Medicaid recipients who are outliers in their 292
use of a single or multiple prescription drugs wi th regard to 293
the numbers and types of drugs taken, drug dosages, combination 294
drug therapies, and other indicators of improper use of 295
prescription drugs. 296
(IV) Alert prescribers to recipients who fail to refill 297
prescriptions in a timely fashion, are prescr ibed multiple drugs 298
that may be redundant or contraindicated, or may have other 299
potential medication problems. 300
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10. The agency may contract for drug rebate 301
administration, including, but not limited to, calculating 302
rebate amounts, invoicing manufacturers, negotiating disputes 303
with manufacturers, and maintaining a database of rebate 304
collections. 305
11. The agency may specify the preferred daily dosing form 306
or strength for the purpose of promoting best practices with 307
regard to the prescribing of certain drugs as specified in the 308
General Appropriations Act and ensuring cost -effective 309
prescribing practices. 310
12. The agency may require prior authorization for 311
Medicaid-covered prescribed drugs. The agency may prior -312
authorize the use of a product: 313
a. For an indication not approved in labeling; 314
b. To comply with certain clinical guidelines; or 315
c. If the product has the potential for overuse, misuse, 316
or abuse. 317
318
The agency may require the prescribing professional to provide 319
information about the rationale an d supporting medical evidence 320
for the use of a drug. The agency shall post prior 321
authorization, step-edit criteria and protocol, and updates to 322
the list of drugs that are subject to prior authorization on the 323
agency's Internet website within 21 days after the prior 324
authorization and step -edit criteria and protocol and updates 325
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are approved by the agency. For purposes of this subparagraph, 326
the term "step-edit" means an automatic electronic review of 327
certain medications subject to prior authorization. 328
13. The agency, in conjunction with the Pharmaceutical and 329
Therapeutics Committee, may require age -related prior 330
authorizations for certain prescribed drugs. The agency may 331
preauthorize the use of a drug for a recipient who may not meet 332
the age requirement or ma y exceed the length of therapy for use 333
of this product as recommended by the manufacturer and approved 334
by the Food and Drug Administration. Prior authorization may 335
require the prescribing professional to provide information 336
about the rationale and supporti ng medical evidence for the use 337
of a drug. 338
14. The agency shall implement a step -therapy prior 339
authorization approval process for medications excluded from the 340
preferred drug list. Medications listed on the preferred drug 341
list must be used within the pre vious 12 months before the 342
alternative medications that are not listed. The step -therapy 343
prior authorization may require the prescriber to use the 344
medications of a similar drug class or for a similar medical 345
indication unless contraindicated in the Food an d Drug 346
Administration labeling. The trial period between the specified 347
steps may vary according to the medical indication. The step -348
therapy approval process must shall be developed in accordance 349
with the committee as stated in s. 409.91195(7) and (8). A dr ug 350
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product may be approved or, in the case of a drug product for 351
the treatment of a serious mental illness, must be approved 352
without meeting the step -therapy prior authorization criteria if 353
the prescribing physician provides the agency with additional 354
written medical or clinical documentation that the product is 355
medically necessary because: 356
a. There is not a drug on the preferred drug list to treat 357
the disease or medical condition which is an acceptable clinical 358
alternative; 359
b. The alternatives have bee n ineffective in the treatment 360
of the beneficiary's disease; 361
c. The drug product or medication of a similar drug class 362
is prescribed for the treatment of a serious mental illness 363
schizophrenia or schizotypal or delusional disorders ; prior 364
authorization has been granted previously for the prescribed 365
drug; and the medication was dispensed to the patient during the 366
previous 12 months; or 367
d. Based on historical evidence and known characteristics 368
of the patient and the drug, the drug is likely to be 369
ineffective, or the number of doses have been ineffective. 370
371
The agency shall work with the physician to determine the best 372
alternative for the patient. The agency may adopt rules waiving 373
the requirements for written clinical documentation for specific 374
drugs in limited clinical situations. 375
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15. The agency shall implement a return and reuse program 376
for drugs dispensed by pharmacies to institutional recipients, 377
which includes payment of a $5 restocking fee for the 378
implementation and operation of the program. The retu rn and 379
reuse program shall be implemented electronically and in a 380
manner that promotes efficiency. The program must permit a 381
pharmacy to exclude drugs from the program if it is not 382
practical or cost-effective for the drug to be included and must 383
provide for the return to inventory of drugs that cannot be 384
credited or returned in a cost -effective manner. The agency 385
shall determine if the program has reduced the amount of 386
Medicaid prescription drugs which are destroyed on an annual 387
basis and if there are addit ional ways to ensure more 388
prescription drugs are not destroyed which could safely be 389
reused. 390
Section 3. Paragraph (a) of subsection (20) of section 391
409.910, Florida Statutes, is amended to read: 392
409.910 Responsibility for payments on behalf of Medica id-393
eligible persons when other parties are liable. — 394
(20)(a) Entities providing health insurance as defined in 395
s. 624.603, health maintenance organizations and prepaid health 396
clinics as defined in chapter 641, and, on behalf of their 397
clients, third-party administrators, pharmacy benefits managers, 398
and any other third parties, as defined in s. 409.901(28) s. 399
409.901(27), which are legally responsible for payment of a 400
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claim for a health care item or service as a condition of doing 401
business in this the state or providing coverage to residents of 402
this state, shall provide such records and information as are 403
necessary to accomplish the purpose of this section, unless such 404
requirement results in an unreasonable burden. 405
Section 4. This act shall take effect July 1, 2023. 406