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A bill to be entitled 1
An act relating to prescription drugs used in the 2
treatment of schizophrenia for Medicaid recipients; 3
amending s. 409.912, F.S.; authorizing the approval of 4
drug products or certain medication prescribed for the 5
treatment of schizophrenia or schizotypal or 6
delusional disorders for Medicaid recipients who have 7
not met the step-therapy prior authorization criteria, 8
when the drug product or certain medication meets 9
specified criteria; providing an effective date. 10
11
Be It Enacted by the Legislature of the State of Florida: 12
13
Section 1. Paragraph (a) of subsection (5) of section 14
409.912, Florida Statutes, is amended to read: 15
409.912 Cost-effective purchasing of health care.—The 16
agency shall purchase goods and services for Medicaid recipients 17
in the most cost-effective manner consistent with the delivery 18
of quality medical care. To ensure that medical services are 19
effectively utilized, the agency may, in any case, require a 20
confirmation or second physician's opinion of the correct 21
diagnosis for purposes of authorizing future services under the 22
Medicaid program. This section does not restrict access to 23
emergency services or poststabilization care services as defined 24
in 42 C.F.R. s. 438.114. Such confirmation or second opinion 25
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shall be rendered in a manner approved by the agency. The agency 26
shall maximize the use of prepaid per capita and prepaid 27
aggregate fixed-sum basis services when appropriate and other 28
alternative service delivery and reimbursement methodologies, 29
including competitive bidding pursuant to s. 287.057, designed 30
to facilitate the cost -effective purchase of a case -managed 31
continuum of care. The agency shall also require providers to 32
minimize the exposure of recipients to the need for acute 33
inpatient, custodial, and other institutional care and the 34
inappropriate or unnecessary use of high -cost services. The 35
agency shall contract with a vendor to monitor and evaluate the 36
clinical practice patterns of prov iders in order to identify 37
trends that are outside the normal practice patterns of a 38
provider's professional peers or the national guidelines of a 39
provider's professional association. The vendor must be able to 40
provide information and counseling to a provi der whose practice 41
patterns are outside the norms, in consultation with the agency, 42
to improve patient care and reduce inappropriate utilization. 43
The agency may mandate prior authorization, drug therapy 44
management, or disease management participation for c ertain 45
populations of Medicaid beneficiaries, certain drug classes, or 46
particular drugs to prevent fraud, abuse, overuse, and possible 47
dangerous drug interactions. The Pharmaceutical and Therapeutics 48
Committee shall make recommendations to the agency on dr ugs for 49
which prior authorization is required. The agency shall inform 50
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the Pharmaceutical and Therapeutics Committee of its decisions 51
regarding drugs subject to prior authorization. The agency is 52
authorized to limit the entities it contracts with or enroll s as 53
Medicaid providers by developing a provider network through 54
provider credentialing. The agency may competitively bid single -55
source-provider contracts if procurement of goods or services 56
results in demonstrated cost savings to the state without 57
limiting access to care. The agency may limit its network based 58
on the assessment of beneficiary access to care, provider 59
availability, provider quality standards, time and distance 60
standards for access to care, the cultural competence of the 61
provider network, de mographic characteristics of Medicaid 62
beneficiaries, practice and provider -to-beneficiary standards, 63
appointment wait times, beneficiary use of services, provider 64
turnover, provider profiling, provider licensure history, 65
previous program integrity investig ations and findings, peer 66
review, provider Medicaid policy and billing compliance records, 67
clinical and medical record audits, and other factors. Providers 68
are not entitled to enrollment in the Medicaid provider network. 69
The agency shall determine instance s in which allowing Medicaid 70
beneficiaries to purchase durable medical equipment and other 71
goods is less expensive to the Medicaid program than long -term 72
rental of the equipment or goods. The agency may establish rules 73
to facilitate purchases in lieu of lo ng-term rentals in order to 74
protect against fraud and abuse in the Medicaid program as 75
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defined in s. 409.913. The agency may seek federal waivers 76
necessary to administer these policies. 77
(5)(a) The agency shall implement a Medicaid prescribed -78
drug spending-control program that includes the following 79
components: 80
1. A Medicaid preferred drug list, which shall be a 81
listing of cost-effective therapeutic options recommended by the 82
Medicaid Pharmacy and Therapeutics Committee established 83
pursuant to s. 409.911 95 and adopted by the agency for each 84
therapeutic class on the preferred drug list. At the discretion 85
of the committee, and when feasible, the preferred drug list 86
should include at least two products in a therapeutic class. The 87
agency may post the preferre d drug list and updates to the list 88
on an Internet website without following the rulemaking 89
procedures of chapter 120. Antiretroviral agents are excluded 90
from the preferred drug list. The agency shall also limit the 91
amount of a prescribed drug dispensed to no more than a 34-day 92
supply unless the drug products' smallest marketed package is 93
greater than a 34-day supply, or the drug is determined by the 94
agency to be a maintenance drug in which case a 100 -day maximum 95
supply may be authorized. The agency may see k any federal 96
waivers necessary to implement these cost -control programs and 97
to continue participation in the federal Medicaid rebate 98
program, or alternatively to negotiate state -only manufacturer 99
rebates. The agency may adopt rules to administer this 100
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subparagraph. The agency shall continue to provide unlimited 101
contraceptive drugs and items. The agency must establish 102
procedures to ensure that: 103
a. There is a response to a request for prior 104
authorization by telephone or other telecommunication device 105
within 24 hours after receipt of a request for prior 106
authorization; and 107
b. A 72-hour supply of the drug prescribed is provided in 108
an emergency or when the agency does not provide a response 109
within 24 hours as required by sub -subparagraph a. 110
2. A provider of prescribed drugs is reimbursed in an 111
amount not to exceed the lesser of the actual acquisition cost 112
based on the Centers for Medicare and Medicaid Services National 113
Average Drug Acquisition Cost pricing files plus a professional 114
dispensing fee, the wholesa le acquisition cost plus a 115
professional dispensing fee, the state maximum allowable cost 116
plus a professional dispensing fee, or the usual and customary 117
charge billed by the provider. 118
3. The agency shall develop and implement a process for 119
managing the drug therapies of Medicaid recipients who are using 120
significant numbers of prescribed drugs each month. The 121
management process may include, but is not limited to, 122
comprehensive, physician -directed medical-record reviews, claims 123
analyses, and case evaluations to determine the medical 124
necessity and appropriateness of a patient's treatment plan and 125
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drug therapies. The agency may contract with a private 126
organization to provide drug -program-management services. The 127
Medicaid drug benefit management program shall in clude 128
initiatives to manage drug therapies for HIV/AIDS patients, 129
patients using 20 or more unique prescriptions in a 180 -day 130
period, and the top 1,000 patients in annual spending. The 131
agency shall enroll any Medicaid recipient in the drug benefit 132
management program if he or she meets the specifications of this 133
provision and is not enrolled in a Medicaid health maintenance 134
organization. 135
4. The agency may limit the size of its pharmacy network 136
based on need, competitive bidding, price negotiations, 137
credentialing, or similar criteria. The agency shall give 138
special consideration to rural areas in determining the size and 139
location of pharmacies included in the Medicaid pharmacy 140
network. A pharmacy credentialing process may include criteria 141
such as a pharmacy's full-service status, location, size, 142
patient educational programs, patient consultation, disease 143
management services, and other characteristics. The agency may 144
impose a moratorium on Medicaid pharmacy enrollment if it is 145
determined that it has a sufficien t number of Medicaid -146
participating providers. The agency must allow dispensing 147
practitioners to participate as a part of the Medicaid pharmacy 148
network regardless of the practitioner's proximity to any other 149
entity that is dispensing prescription drugs unde r the Medicaid 150
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program. A dispensing practitioner must meet all credentialing 151
requirements applicable to his or her practice, as determined by 152
the agency. 153
5. The agency shall develop and implement a program that 154
requires Medicaid practitioners who issue written prescriptions 155
for medicinal drugs to use a counterfeit -proof prescription pad 156
for Medicaid prescriptions. The agency shall require the use of 157
standardized counterfeit -proof prescription pads by prescribers 158
who issue written prescriptions for Medica id recipients. The 159
agency may implement the program in targeted geographic areas or 160
statewide. 161
6. The agency may enter into arrangements that require 162
manufacturers of generic drugs prescribed to Medicaid recipients 163
to provide rebates of at least 15.1 per cent of the average 164
manufacturer price for the manufacturer's generic products. 165
These arrangements shall require that if a generic -drug 166
manufacturer pays federal rebates for Medicaid -reimbursed drugs 167
at a level below 15.1 percent, the manufacturer must pro vide a 168
supplemental rebate to the state in an amount necessary to 169
achieve a 15.1-percent rebate level. 170
7. The agency may establish a preferred drug list as 171
described in this subsection, and, pursuant to the establishment 172
of such preferred drug list, nego tiate supplemental rebates from 173
manufacturers that are in addition to those required by Title 174
XIX of the Social Security Act and at no less than 14 percent of 175
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the average manufacturer price as defined in 42 U.S.C. s. 1936 176
on the last day of a quarter unles s the federal or supplemental 177
rebate, or both, equals or exceeds 29 percent. There is no upper 178
limit on the supplemental rebates the agency may negotiate. The 179
agency may determine that specific products, brand -name or 180
generic, are competitive at lower reba te percentages. Agreement 181
to pay the minimum supplemental rebate percentage guarantees a 182
manufacturer that the Medicaid Pharmaceutical and Therapeutics 183
Committee will consider a product for inclusion on the preferred 184
drug list. However, a pharmaceutical ma nufacturer is not 185
guaranteed placement on the preferred drug list by simply paying 186
the minimum supplemental rebate. Agency decisions will be made 187
on the clinical efficacy of a drug and recommendations of the 188
Medicaid Pharmaceutical and Therapeutics Committ ee, as well as 189
the price of competing products minus federal and state rebates. 190
The agency may contract with an outside agency or contractor to 191
conduct negotiations for supplemental rebates. For the purposes 192
of this section, the term "supplemental rebates" means cash 193
rebates. Value-added programs as a substitution for supplemental 194
rebates are prohibited. The agency may seek any federal waivers 195
to implement this initiative. 196
8.a. The agency may implement a Medicaid behavioral drug 197
management system. The age ncy may contract with a vendor that 198
has experience in operating behavioral drug management systems 199
to implement this program. The agency may seek federal waivers 200
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to implement this program. 201
b. The agency, in conjunction with the Department of 202
Children and Families, may implement the Medicaid behavioral 203
drug management system that is designed to improve the quality 204
of care and behavioral health prescribing practices based on 205
best practice guidelines, improve patient adherence to 206
medication plans, reduce cli nical risk, and lower prescribed 207
drug costs and the rate of inappropriate spending on Medicaid 208
behavioral drugs. The program may include the following 209
elements: 210
(I) Provide for the development and adoption of best 211
practice guidelines for behavioral healt h-related drugs such as 212
antipsychotics, antidepressants, and medications for treating 213
bipolar disorders and other behavioral conditions; translate 214
them into practice; review behavioral health prescribers and 215
compare their prescribing patterns to a number o f indicators 216
that are based on national standards; and determine deviations 217
from best practice guidelines. 218
(II) Implement processes for providing feedback to and 219
educating prescribers using best practice educational materials 220
and peer-to-peer consultation. 221
(III) Assess Medicaid beneficiaries who are outliers in 222
their use of behavioral health drugs with regard to the numbers 223
and types of drugs taken, drug dosages, combination drug 224
therapies, and other indicators of improper use of behavioral 225
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health drugs. 226
(IV) Alert prescribers to patients who fail to refill 227
prescriptions in a timely fashion, are prescribed multiple same -228
class behavioral health drugs, and may have other potential 229
medication problems. 230
(V) Track spending trends for behavioral health dru gs and 231
deviation from best practice guidelines. 232
(VI) Use educational and technological approaches to 233
promote best practices, educate consumers, and train prescribers 234
in the use of practice guidelines. 235
(VII) Disseminate electronic and published material s. 236
(VIII) Hold statewide and regional conferences. 237
(IX) Implement a disease management program with a model 238
quality-based medication component for severely mentally ill 239
individuals and emotionally disturbed children who are high 240
users of care. 241
9. The agency shall implement a Medicaid prescription drug 242
management system. 243
a. The agency may contract with a vendor that has 244
experience in operating prescription drug management systems in 245
order to implement this system. Any management system that is 246
implemented in accordance with this subparagraph must rely on 247
cooperation between physicians and pharmacists to determine 248
appropriate practice patterns and clinical guidelines to improve 249
the prescribing, dispensing, and use of drugs in the Medicaid 250
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program. The agency may seek federal waivers to implement this 251
program. 252
b. The drug management system must be designed to improve 253
the quality of care and prescribing practices based on best 254
practice guidelines, improve patient adherence to medication 255
plans, reduce clinical risk, and lower prescribed drug costs and 256
the rate of inappropriate spending on Medicaid prescription 257
drugs. The program must: 258
(I) Provide for the adoption of best practice guidelines 259
for the prescribing and use of drugs in the Medicaid program, 260
including translating best practice guidelines into practice; 261
reviewing prescriber patterns and comparing them to indicators 262
that are based on national standards and practice patterns of 263
clinical peers in their community, statewide, and nationally; 264
and determine deviations from best practice guidelines. 265
(II) Implement processes for providing feedback to and 266
educating prescribers using best practice educational materials 267
and peer-to-peer consultation. 268
(III) Assess Medicaid recipients who are outliers in t heir 269
use of a single or multiple prescription drugs with regard to 270
the numbers and types of drugs taken, drug dosages, combination 271
drug therapies, and other indicators of improper use of 272
prescription drugs. 273
(IV) Alert prescribers to recipients who fail t o refill 274
prescriptions in a timely fashion, are prescribed multiple drugs 275
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that may be redundant or contraindicated, or may have other 276
potential medication problems. 277
10. The agency may contract for drug rebate 278
administration, including, but not limited to , calculating 279
rebate amounts, invoicing manufacturers, negotiating disputes 280
with manufacturers, and maintaining a database of rebate 281
collections. 282
11. The agency may specify the preferred daily dosing form 283
or strength for the purpose of promoting best pra ctices with 284
regard to the prescribing of certain drugs as specified in the 285
General Appropriations Act and ensuring cost -effective 286
prescribing practices. 287
12. The agency may require prior authorization for 288
Medicaid-covered prescribed drugs. The agency may prior-289
authorize the use of a product: 290
a. For an indication not approved in labeling; 291
b. To comply with certain clinical guidelines; or 292
c. If the product has the potential for overuse, misuse, 293
or abuse. 294
295
The agency may require the prescribing professi onal to provide 296
information about the rationale and supporting medical evidence 297
for the use of a drug. The agency shall post prior 298
authorization, step-edit criteria and protocol, and updates to 299
the list of drugs that are subject to prior authorization on t he 300
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agency's Internet website within 21 days after the prior 301
authorization and step -edit criteria and protocol and updates 302
are approved by the agency. For purposes of this subparagraph, 303
the term "step-edit" means an automatic electronic review of 304
certain medications subject to prior authorization. 305
13. The agency, in conjunction with the Pharmaceutical and 306
Therapeutics Committee, may require age -related prior 307
authorizations for certain prescribed drugs. The agency may 308
preauthorize the use of a drug for a re cipient who may not meet 309
the age requirement or may exceed the length of therapy for use 310
of this product as recommended by the manufacturer and approved 311
by the Food and Drug Administration. Prior authorization may 312
require the prescribing professional to pr ovide information 313
about the rationale and supporting medical evidence for the use 314
of a drug. 315
14. The agency shall implement a step -therapy prior 316
authorization approval process for medications excluded from the 317
preferred drug list. Medications listed on t he preferred drug 318
list must be used within the previous 12 months before the 319
alternative medications that are not listed. The step -therapy 320
prior authorization may require the prescriber to use the 321
medications of a similar drug class or for a similar medica l 322
indication unless contraindicated in the Food and Drug 323
Administration labeling. The trial period between the specified 324
steps may vary according to the medical indication. The step -325
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therapy approval process shall be developed in accordance with 326
the committee as stated in s. 409.91195(7) and (8). A drug 327
product may be approved without meeting the step -therapy prior 328
authorization criteria if the prescribing physician provides the 329
agency with additional written medical or clinical documentation 330
that the product is medically necessary because: 331
a. There is not a drug on the preferred drug list to treat 332
the disease or medical condition which is an acceptable clinical 333
alternative; 334
b. The alternatives have been ineffective in the treatment 335
of the beneficiary's d isease; or 336
c. The drug product or medication of a similar drug class 337
is prescribed for the treatment of schizophrenia or schizotypal 338
or delusional disorders; prior authorization has been granted 339
previously for the prescribed drug; and the medication was 340
dispensed to the patient during the previous 12 months; or 341
d. Based on historic evidence and known characteristics of 342
the patient and the drug, the drug is likely to be ineffective, 343
or the number of doses have been ineffective. 344
345
The agency shall work wit h the physician to determine the best 346
alternative for the patient. The agency may adopt rules waiving 347
the requirements for written clinical documentation for specific 348
drugs in limited clinical situations. 349
15. The agency shall implement a return and reuse program 350
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for drugs dispensed by pharmacies to institutional recipients, 351
which includes payment of a $5 restocking fee for the 352
implementation and operation of the program. The return and 353
reuse program shall be implemented electronically and in a 354
manner that promotes efficiency. The program must permit a 355
pharmacy to exclude drugs from the program if it is not 356
practical or cost-effective for the drug to be included and must 357
provide for the return to inventory of drugs that cannot be 358
credited or returned in a c ost-effective manner. The agency 359
shall determine if the program has reduced the amount of 360
Medicaid prescription drugs which are destroyed on an annual 361
basis and if there are additional ways to ensure more 362
prescription drugs are not destroyed which could sa fely be 363
reused. 364
Section 2. This act shall take effect July 1, 2022. 365