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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; directing 10
the agency to include the rate impact of this act in 11
certain program rates that become effective on a 12
specified date; providing an effective date. 13
14
Be It Enacted by the Legislature of the S tate of Florida: 15
16
Section 1. Present subsections (27) and (28) of section 17
409.901, Florida Statutes, are redesignated as subsections (28) 18
and (29), respectively, and a new subsection (27) is added to 19
that section, to read: 20
409.901 Definitions; ss. 40 9.901-409.920.—As used in ss. 21
409.901-409.920, except as otherwise specifically provided, the 22
term: 23
(27) "Serious mental illness" means any of the following 24
psychiatric disorders as defined by the American Psychiatric 25
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Association in the Diagnostic and St atistical Manual of Mental 26
Disorders, Fifth Edition: 27
(a) Bipolar disorders, including hypomanic, manic, 28
depressive, and mixed -feature episodes. 29
(b) Depression in childhood or adolescence. 30
(c) Major depressive disorders, including single and 31
recurrent depressive episodes. 32
(d) Obsessive-compulsive disorders. 33
(e) Paranoid personality disorder or other psychotic 34
disorders. 35
(f) Schizoaffective disorders, including bipolar or 36
depressive symptoms. 37
(g) Schizophrenia. 38
Section 2. Paragraph (a) of su bsection (5) of section 39
409.912, Florida Statutes, is amended to read: 40
409.912 Cost-effective purchasing of health care. —The 41
agency shall purchase goods and services for Medicaid recipients 42
in the most cost-effective manner consistent with the delivery 43
of quality medical care. To ensure that medical services are 44
effectively utilized, the agency may, in any case, require a 45
confirmation or second physician's opinion of the correct 46
diagnosis for purposes of authorizing future services under the 47
Medicaid program. This section does not restrict access to 48
emergency services or poststabilization care services as defined 49
in 42 C.F.R. s. 438.114. Such confirmation or second opinion 50
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shall be rendered in a manner approved by the agency. The agency 51
shall maximize the use of prepaid per capita and prepaid 52
aggregate fixed-sum basis services when appropriate and other 53
alternative service delivery and reimbursement methodologies, 54
including competitive bidding pursuant to s. 287.057, designed 55
to facilitate the cost -effective purchase of a case -managed 56
continuum of care. The agency shall also require providers to 57
minimize the exposure of recipients to the need for acute 58
inpatient, custodial, and other institutional care and the 59
inappropriate or unnecessary use of high -cost services. The 60
agency shall contract with a vendor to monitor and evaluate the 61
clinical practice patterns of providers in order to identify 62
trends that are outside the normal practice patterns of a 63
provider's professional peers or the national guidelines of a 64
provider's professional association. The vendor must be able to 65
provide information and counseling to a provider whose practice 66
patterns are outside the norms, in consultation with the agency, 67
to improve patient care and reduce inappropriate utilization. 68
The agency may mandate prior authorization, drug therapy 69
management, or disease management participation for certain 70
populations of Medicaid beneficiaries, certain drug classes, or 71
particular drugs to prevent fraud, abuse, overuse, and possible 72
dangerous drug interactions. The Pharmaceutical and Therapeutics 73
Committee shall make recommendations to the agency on drugs for 74
which prior authorization is required. The agency shall inform 75
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the Pharmaceutical and Therapeutics Committee of its decisions 76
regarding drugs subject to prior authorization. The agency is 77
authorized to limit the entities it contracts with or enrolls as 78
Medicaid providers by developing a provider network through 79
provider credentialing. The agency may competitively bid single -80
source-provider contracts if procurement of goods or services 81
results in demonstrated cost savings to the state without 82
limiting access to care. The agency may limit its network based 83
on the assessment of beneficiary access to care, provider 84
availability, provider quality standards, time and distance 85
standards for access to care, the cultural competence of the 86
provider network, demographic characteristics of Medicaid 87
beneficiaries, practice and provider -to-beneficiary standards, 88
appointment wait times, beneficiary use of se rvices, provider 89
turnover, provider profiling, provider licensure history, 90
previous program integrity investigations and findings, peer 91
review, provider Medicaid policy and billing compliance records, 92
clinical and medical record audits, and other factors. Providers 93
are not entitled to enrollment in the Medicaid provider network. 94
The agency shall determine instances in which allowing Medicaid 95
beneficiaries to purchase durable medical equipment and other 96
goods is less expensive to the Medicaid program than lo ng-term 97
rental of the equipment or goods. The agency may establish rules 98
to facilitate purchases in lieu of long -term rentals in order to 99
protect against fraud and abuse in the Medicaid program as 100
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defined in s. 409.913. The agency may seek federal waivers 101
necessary to administer these policies. 102
(5)(a) The agency shall implement a Medicaid prescribed -103
drug spending-control program that includes the following 104
components: 105
1. A Medicaid preferred drug list, which shall be a 106
listing of cost-effective therapeutic options recommended by the 107
Medicaid Pharmacy and Therapeutics Committee established 108
pursuant to s. 409.91195 and adopted by the agency for each 109
therapeutic class on the preferred drug list. At the discretion 110
of the committee, and when feasible, the preferred drug list 111
should include at least two products in a therapeutic class. The 112
agency may post the preferred drug list and updates to the list 113
on an Internet website without following the rulemaking 114
procedures of chapter 120. Antiretroviral agents are excluded 115
from the preferred drug list. The agency shall also limit the 116
amount of a prescribed drug dispensed to no more than a 34 -day 117
supply unless the drug products' sma llest marketed package is 118
greater than a 34-day supply, or the drug is determined by the 119
agency to be a maintenance drug in which case a 100 -day maximum 120
supply may be authorized. The agency may seek any federal 121
waivers necessary to implement these cost -control programs and 122
to continue participation in the federal Medicaid rebate 123
program, or alternatively to negotiate state -only manufacturer 124
rebates. The agency may adopt rules to administer this 125
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subparagraph. The agency shall continue to provide unlimited 126
contraceptive drugs and items. The agency must establish 127
procedures to ensure that: 128
a. There is a response to a request for prior 129
authorization by telephone or other telecommunication device 130
within 24 hours after receipt of a request for prior 131
authorization; and 132
b. A 72-hour supply of the drug prescribed is provided in 133
an emergency or when the agency does not provide a response 134
within 24 hours as required by sub -subparagraph a. 135
2. A provider of prescribed drugs is reimbursed in an 136
amount not to exceed t he lesser of the actual acquisition cost 137
based on the Centers for Medicare and Medicaid Services National 138
Average Drug Acquisition Cost pricing files plus a professional 139
dispensing fee, the wholesale acquisition cost plus a 140
professional dispensing fee, the state maximum allowable cost 141
plus a professional dispensing fee, or the usual and customary 142
charge billed by the provider. 143
3. The agency shall develop and implement a process for 144
managing the drug therapies of Medicaid recipients who are using 145
significant numbers of prescribed drugs each month. The 146
management process may include, but is not limited to, 147
comprehensive, physician -directed medical-record reviews, claims 148
analyses, and case evaluations to determine the medical 149
necessity and appropriateness of a patient's treatment plan and 150
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drug therapies. The agency may contract with a private 151
organization to provide drug -program-management services. The 152
Medicaid drug benefit management program shall include 153
initiatives to manage drug therapies for HIV/AIDS pat ients, 154
patients using 20 or more unique prescriptions in a 180 -day 155
period, and the top 1,000 patients in annual spending. The 156
agency shall enroll any Medicaid recipient in the drug benefit 157
management program if he or she meets the specifications of this 158
provision and is not enrolled in a Medicaid health maintenance 159
organization. 160
4. The agency may limit the size of its pharmacy network 161
based on need, competitive bidding, price negotiations, 162
credentialing, or similar criteria. The agency shall give 163
special consideration to rural areas in determining the size and 164
location of pharmacies included in the Medicaid pharmacy 165
network. A pharmacy credentialing process may include criteria 166
such as a pharmacy's full -service status, location, size, 167
patient educational p rograms, patient consultation, disease 168
management services, and other characteristics. The agency may 169
impose a moratorium on Medicaid pharmacy enrollment if it is 170
determined that it has a sufficient number of Medicaid -171
participating providers. The agency mu st allow dispensing 172
practitioners to participate as a part of the Medicaid pharmacy 173
network regardless of the practitioner's proximity to any other 174
entity that is dispensing prescription drugs under the Medicaid 175
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program. A dispensing practitioner must meet all credentialing 176
requirements applicable to his or her practice, as determined by 177
the agency. 178
5. The agency shall develop and implement a program that 179
requires Medicaid practitioners who issue written prescriptions 180
for medicinal drugs to use a counterf eit-proof prescription pad 181
for Medicaid prescriptions. The agency shall require the use of 182
standardized counterfeit -proof prescription pads by prescribers 183
who issue written prescriptions for Medicaid recipients. The 184
agency may implement the program in targ eted geographic areas or 185
statewide. 186
6. The agency may enter into arrangements that require 187
manufacturers of generic drugs prescribed to Medicaid recipients 188
to provide rebates of at least 15.1 percent of the average 189
manufacturer price for the manufacturer 's generic products. 190
These arrangements must shall require that if a generic -drug 191
manufacturer pays federal rebates for Medicaid -reimbursed drugs 192
at a level below 15.1 percent, the manufacturer must provide a 193
supplemental rebate to the state in an amount n ecessary to 194
achieve a 15.1-percent rebate level. 195
7. The agency may establish a preferred drug list as 196
described in this subsection, and, pursuant to the establishment 197
of such preferred drug list, negotiate supplemental rebates from 198
manufacturers that are in addition to those required by Title 199
XIX of the Social Security Act and at no less than 14 percent of 200
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the average manufacturer price as defined in 42 U.S.C. s. 1936 201
on the last day of a quarter unless the federal or supplemental 202
rebate, or both, equals or exceeds 29 percent. There is no upper 203
limit on the supplemental rebates the agency may negotiate. The 204
agency may determine that specific products, brand -name or 205
generic, are competitive at lower rebate percentages. Agreement 206
to pay the minimum supplemen tal rebate percentage guarantees a 207
manufacturer that the Medicaid Pharmaceutical and Therapeutics 208
Committee will consider a product for inclusion on the preferred 209
drug list. However, a pharmaceutical manufacturer is not 210
guaranteed placement on the preferre d drug list by simply paying 211
the minimum supplemental rebate. Agency decisions will be made 212
on the clinical efficacy of a drug and recommendations of the 213
Medicaid Pharmaceutical and Therapeutics Committee, as well as 214
the price of competing products minus f ederal and state rebates. 215
The agency may contract with an outside agency or contractor to 216
conduct negotiations for supplemental rebates. For the purposes 217
of this section, the term "supplemental rebates" means cash 218
rebates. Value-added programs as a substit ution for supplemental 219
rebates are prohibited. The agency may seek any federal waivers 220
to implement this initiative. 221
8.a. The agency may implement a Medicaid behavioral drug 222
management system. The agency may contract with a vendor that 223
has experience in operating behavioral drug management systems 224
to implement this program. The agency may seek federal waivers 225
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to implement this program. 226
b. The agency, in conjunction with the Department of 227
Children and Families, may implement the Medicaid behavioral 228
drug management system that is designed to improve the quality 229
of care and behavioral health prescribing practices based on 230
best practice guidelines, improve patient adherence to 231
medication plans, reduce clinical risk, and lower prescribed 232
drug costs and the ra te of inappropriate spending on Medicaid 233
behavioral drugs. The program may include the following 234
elements: 235
(I) Provide for the development and adoption of best 236
practice guidelines for behavioral health -related drugs such as 237
antipsychotics, antidepressant s, and medications for treating 238
bipolar disorders and other behavioral conditions; translate 239
them into practice; review behavioral health prescribers and 240
compare their prescribing patterns to a number of indicators 241
that are based on national standards; and determine deviations 242
from best practice guidelines. 243
(II) Implement processes for providing feedback to and 244
educating prescribers using best practice educational materials 245
and peer-to-peer consultation. 246
(III) Assess Medicaid beneficiaries who are outli ers in 247
their use of behavioral health drugs with regard to the numbers 248
and types of drugs taken, drug dosages, combination drug 249
therapies, and other indicators of improper use of behavioral 250
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health drugs. 251
(IV) Alert prescribers to patients who fail to ref ill 252
prescriptions in a timely fashion, are prescribed multiple same -253
class behavioral health drugs, and may have other potential 254
medication problems. 255
(V) Track spending trends for behavioral health drugs and 256
deviation from best practice guidelines. 257
(VI) Use educational and technological approaches to 258
promote best practices, educate consumers, and train prescribers 259
in the use of practice guidelines. 260
(VII) Disseminate electronic and published materials. 261
(VIII) Hold statewide and regional conferences. 262
(IX) Implement a disease management program with a model 263
quality-based medication component for severely mentally ill 264
individuals and emotionally disturbed children who are high 265
users of care. 266
9. The agency shall implement a Medicaid prescription drug 267
management system. 268
a. The agency may contract with a vendor that has 269
experience in operating prescription drug management systems in 270
order to implement this system. Any management system that is 271
implemented in accordance with this subparagraph must rely o n 272
cooperation between physicians and pharmacists to determine 273
appropriate practice patterns and clinical guidelines to improve 274
the prescribing, dispensing, and use of drugs in the Medicaid 275
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program. The agency may seek federal waivers to implement this 276
program. 277
b. The drug management system must be designed to improve 278
the quality of care and prescribing practices based on best 279
practice guidelines, improve patient adherence to medication 280
plans, reduce clinical risk, and lower prescribed drug costs and 281
the rate of inappropriate spending on Medicaid prescription 282
drugs. The program must: 283
(I) Provide for the adoption of best practice guidelines 284
for the prescribing and use of drugs in the Medicaid program, 285
including translating best practice guidelines into pra ctice; 286
reviewing prescriber patterns and comparing them to indicators 287
that are based on national standards and practice patterns of 288
clinical peers in their community, statewide, and nationally; 289
and determine deviations from best practice guidelines. 290
(II) Implement processes for providing feedback to and 291
educating prescribers using best practice educational materials 292
and peer-to-peer consultation. 293
(III) Assess Medicaid recipients who are outliers in their 294
use of a single or multiple prescription drugs wi th regard to 295
the numbers and types of drugs taken, drug dosages, combination 296
drug therapies, and other indicators of improper use of 297
prescription drugs. 298
(IV) Alert prescribers to recipients who fail to refill 299
prescriptions in a timely fashion, are prescr ibed multiple drugs 300
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that may be redundant or contraindicated, or may have other 301
potential medication problems. 302
10. The agency may contract for drug rebate 303
administration, including, but not limited to, calculating 304
rebate amounts, invoicing manufacturers, negotiating disputes 305
with manufacturers, and maintaining a database of rebate 306
collections. 307
11. The agency may specify the preferred daily dosing form 308
or strength for the purpose of promoting best practices with 309
regard to the prescribing of certain drugs as specified in the 310
General Appropriations Act and ensuring cost -effective 311
prescribing practices. 312
12. The agency may require prior authorization for 313
Medicaid-covered prescribed drugs. The agency may prior -314
authorize the use of a product: 315
a. For an indication not approved in labeling; 316
b. To comply with certain clinical guidelines; or 317
c. If the product has the potential for overuse, misuse, 318
or abuse. 319
320
The agency may require the prescribing professional to provide 321
information about the rationale an d supporting medical evidence 322
for the use of a drug. The agency shall post prior 323
authorization, step-edit criteria and protocol, and updates to 324
the list of drugs that are subject to prior authorization on the 325
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agency's Internet website within 21 days after the prior 326
authorization and step -edit criteria and protocol and updates 327
are approved by the agency. For purposes of this subparagraph, 328
the term "step-edit" means an automatic electronic review of 329
certain medications subject to prior authorization. 330
13. The agency, in conjunction with the Pharmaceutical and 331
Therapeutics Committee, may require age -related prior 332
authorizations for certain prescribed drugs. The agency may 333
preauthorize the use of a drug for a recipient who may not meet 334
the age requirement or ma y exceed the length of therapy for use 335
of this product as recommended by the manufacturer and approved 336
by the Food and Drug Administration. Prior authorization may 337
require the prescribing professional to provide information 338
about the rationale and supporti ng medical evidence for the use 339
of a drug. 340
14. The agency shall implement a step -therapy prior 341
authorization approval process for medications excluded from the 342
preferred drug list. Medications listed on the preferred drug 343
list must be used within the pre vious 12 months before the 344
alternative medications that are not listed. The step -therapy 345
prior authorization may require the prescriber to use the 346
medications of a similar drug class or for a similar medical 347
indication unless contraindicated in the Food an d Drug 348
Administration labeling. The trial period between the specified 349
steps may vary according to the medical indication. The step -350
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therapy approval process must shall be developed in accordance 351
with the committee as stated in s. 409.91195(7) and (8). A dr ug 352
product may be approved or, in the case of a drug product for 353
the treatment of a serious mental illness, must be approved 354
without meeting the step -therapy prior authorization criteria if 355
the prescribing physician provides the agency with additional 356
written medical or clinical documentation that the product is 357
medically necessary because: 358
a. There is not a drug on the preferred drug list to treat 359
the disease or medical condition which is an acceptable clinical 360
alternative; 361
b. The alternatives have bee n ineffective in the treatment 362
of the beneficiary's disease; 363
c. The drug product or medication of a similar drug class 364
is prescribed for the treatment of a serious mental illness 365
schizophrenia or schizotypal or delusional disorders ; prior 366
authorization has been granted previously for the prescribed 367
drug; and the medication was dispensed to the patient during the 368
previous 12 months; or 369
d. Based on historical evidence and known characteristics 370
of the patient and the drug, the drug is likely to be 371
ineffective, or the number of doses have been ineffective. 372
373
The agency shall work with the physician to determine the best 374
alternative for the patient. The agency may adopt rules waiving 375
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the requirements for written clinical documentation for specific 376
drugs in limited clinical situations. 377
15. The agency shall implement a return and reuse program 378
for drugs dispensed by pharmacies to institutional recipients, 379
which includes payment of a $5 restocking fee for the 380
implementation and operation of the program. The retu rn and 381
reuse program shall be implemented electronically and in a 382
manner that promotes efficiency. The program must permit a 383
pharmacy to exclude drugs from the program if it is not 384
practical or cost-effective for the drug to be included and must 385
provide for the return to inventory of drugs that cannot be 386
credited or returned in a cost -effective manner. The agency 387
shall determine if the program has reduced the amount of 388
Medicaid prescription drugs which are destroyed on an annual 389
basis and if there are addit ional ways to ensure more 390
prescription drugs are not destroyed which could safely be 391
reused. 392
Section 3. Paragraph (a) of subsection (20) of section 393
409.910, Florida Statutes, is amended to read: 394
409.910 Responsibility for payments on behalf of Medica id-395
eligible persons when other parties are liable. — 396
(20)(a) Entities providing health insurance as defined in 397
s. 624.603, health maintenance organizations and prepaid health 398
clinics as defined in chapter 641, and, on behalf of their 399
clients, third-party administrators, pharmacy benefits managers, 400
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and any other third parties, as defined in s. 409.901(28) s. 401
409.901(27), which are legally responsible for payment of a 402
claim for a health care item or service as a condition of doing 403
business in this the state or providing coverage to residents of 404
this state, shall provide such records and information as are 405
necessary to accomplish the purpose of this section, unless such 406
requirement results in an unreasonable burden. 407
Section 4. The Agency for Health Care Ad ministration is 408
directed to include the rate impact of this act in the Medicaid 409
managed medical assistance program and long -term care managed 410
care program rates that become effective on October 1, 2023. 411
Section 5. This act shall take effect October 1, 2023. 412