Florida 2024 Regular Session

Florida House Bill H0491 Compare Versions

Only one version of the bill is available at this time.
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1010 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
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1414 A bill to be entitled 1
1515 An act relating to access to appropriate medication 2
1616 for serious mental illness; amending s. 409.901, F.S.; 3
1717 defining the term "serious mental illness"; amending 4
1818 s. 409.912, F.S.; requiring the Agency for Health Care 5
1919 Administration to approve drug products for Medicaid 6
2020 recipients for the treatment of serious mental illness 7
2121 without step-therapy prior authorization under certain 8
2222 circumstances; amending s. 409.910, F. S.; conforming a 9
2323 cross-reference; directing the agency to include the 10
2424 rate impact of this act in certain program rates that 11
2525 become effective on a date certain; providing an 12
2626 effective date. 13
2727 14
2828 Be It Enacted by the Legislature of the State of Florida: 15
2929 16
3030 Section 1. Subsections (27) and (28) of section 409.901, 17
3131 Florida Statutes, are renumbered as subsections (28) and (29), 18
3232 respectively, and a new subsection (27) is added to that 19
3333 section, to read: 20
3434 409.901 Definitions; ss. 409.901 -409.920.—As used in ss. 21
3535 409.901-409.920, except as otherwise specifically provided, the 22
3636 term: 23
3737 (27) "Serious mental illness" means any of the following 24
3838 psychiatric disorders as defined by the American Psychiatric 25
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4747 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
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5151 Association in the Diagnostic and Statistical Manual of Mental 26
5252 Disorders, Fifth Edition: 27
5353 (a) Bipolar disorder, including hypomanic, manic, 28
5454 depressive, and mixed -feature episodes. 29
5555 (b) Depression in childhood or adolescence. 30
5656 (c) Major depressive disorders, including single and 31
5757 recurrent depressive episodes. 32
5858 (d) Obsessive-compulsive disorder. 33
5959 (e) Paranoid personality disorder or other psychotic 34
6060 disorders. 35
6161 (f) Schizoaffective disorder, including bipolar or 36
6262 depressive symptoms. 37
6363 (g) Schizophrenia. 38
6464 Section 2. Paragraph (a) of subsection (5) of section 39
6565 409.912, Florida Statutes, is amended to read: 40
6666 409.912 Cost-effective purchasing of health care. —The 41
6767 agency shall purchase goods and services for Medicaid recipients 42
6868 in the most cost-effective manner consistent with the delivery 43
6969 of quality medical care. To ensure that medical services are 44
7070 effectively utilized, the agency may, in any case, require a 45
7171 confirmation or second physician's opinion of the correct 46
7272 diagnosis for purposes of authorizing future services under the 47
7373 Medicaid program. This section does not restric t access to 48
7474 emergency services or poststabilization care services as defined 49
7575 in 42 C.F.R. s. 438.114. Such confirmation or second opinion 50
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8484 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
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8888 shall be rendered in a manner approved by the agency. The agency 51
8989 shall maximize the use of prepaid per capita and prep aid 52
9090 aggregate fixed-sum basis services when appropriate and other 53
9191 alternative service delivery and reimbursement methodologies, 54
9292 including competitive bidding pursuant to s. 287.057, designed 55
9393 to facilitate the cost -effective purchase of a case -managed 56
9494 continuum of care. The agency shall also require providers to 57
9595 minimize the exposure of recipients to the need for acute 58
9696 inpatient, custodial, and other institutional care and the 59
9797 inappropriate or unnecessary use of high -cost services. The 60
9898 agency shall contract with a vendor to monitor and evaluate the 61
9999 clinical practice patterns of providers in order to identify 62
100100 trends that are outside the normal practice patterns of a 63
101101 provider's professional peers or the national guidelines of a 64
102102 provider's professional associati on. The vendor must be able to 65
103103 provide information and counseling to a provider whose practice 66
104104 patterns are outside the norms, in consultation with the agency, 67
105105 to improve patient care and reduce inappropriate utilization. 68
106106 The agency may mandate prior autho rization, drug therapy 69
107107 management, or disease management participation for certain 70
108108 populations of Medicaid beneficiaries, certain drug classes, or 71
109109 particular drugs to prevent fraud, abuse, overuse, and possible 72
110110 dangerous drug interactions. The Pharmaceutic al and Therapeutics 73
111111 Committee shall make recommendations to the agency on drugs for 74
112112 which prior authorization is required. The agency shall inform 75
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121121 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
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125125 the Pharmaceutical and Therapeutics Committee of its decisions 76
126126 regarding drugs subject to prior authorization . The agency is 77
127127 authorized to limit the entities it contracts with or enrolls as 78
128128 Medicaid providers by developing a provider network through 79
129129 provider credentialing. The agency may competitively bid single -80
130130 source-provider contracts if procurement of goods o r services 81
131131 results in demonstrated cost savings to the state without 82
132132 limiting access to care. The agency may limit its network based 83
133133 on the assessment of beneficiary access to care, provider 84
134134 availability, provider quality standards, time and distance 85
135135 standards for access to care, the cultural competence of the 86
136136 provider network, demographic characteristics of Medicaid 87
137137 beneficiaries, practice and provider -to-beneficiary standards, 88
138138 appointment wait times, beneficiary use of services, provider 89
139139 turnover, provider profiling, provider licensure history, 90
140140 previous program integrity investigations and findings, peer 91
141141 review, provider Medicaid policy and billing compliance records, 92
142142 clinical and medical record audits, and other factors. Providers 93
143143 are not entitled to enro llment in the Medicaid provider network. 94
144144 The agency shall determine instances in which allowing Medicaid 95
145145 beneficiaries to purchase durable medical equipment and other 96
146146 goods is less expensive to the Medicaid program than long -term 97
147147 rental of the equipment or goods. The agency may establish rules 98
148148 to facilitate purchases in lieu of long -term rentals in order to 99
149149 protect against fraud and abuse in the Medicaid program as 100
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158158 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
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162162 defined in s. 409.913. The agency may seek federal waivers 101
163163 necessary to administer these poli cies. 102
164164 (5)(a) The agency shall implement a Medicaid prescribed -103
165165 drug spending-control program that includes the following 104
166166 components: 105
167167 1. A Medicaid preferred drug list, which shall be a 106
168168 listing of cost-effective therapeutic options recommended by the 107
169169 Medicaid Pharmacy and Therapeutics Committee established 108
170170 pursuant to s. 409.91195 and adopted by the agency for each 109
171171 therapeutic class on the preferred drug list. At the discretion 110
172172 of the committee, and when feasible, the preferred drug list 111
173173 should include at least two products in a therapeutic class. The 112
174174 agency may post the preferred drug list and updates to the list 113
175175 on an Internet website without following the rulemaking 114
176176 procedures of chapter 120. Antiretroviral agents are excluded 115
177177 from the preferred drug list. The agency shall also limit the 116
178178 amount of a prescribed drug dispensed to no more than a 34 -day 117
179179 supply unless the drug products' sma llest marketed package is 118
180180 greater than a 34-day supply, or the drug is determined by the 119
181181 agency to be a maintenance drug in which case a 100 -day maximum 120
182182 supply may be authorized. The agency may seek any federal 121
183183 waivers necessary to implement these cost -control programs and 122
184184 to continue participation in the federal Medicaid rebate 123
185185 program, or alternatively to negotiate state -only manufacturer 124
186186 rebates. The agency may adopt rules to administer this 125
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195195 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
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199199 subparagraph. The agency shall continue to provide unlimited 126
200200 contraceptive drugs and items. The agency must establish 127
201201 procedures to ensure that: 128
202202 a. There is a response to a request for prior 129
203203 authorization by telephone or other telecommunication device 130
204204 within 24 hours after receipt of a request for prior 131
205205 authorization; and 132
206206 b. A 72-hour supply of the drug prescribed is provided in 133
207207 an emergency or when the agency does not provide a response 134
208208 within 24 hours as required by sub -subparagraph a. 135
209209 2. A provider of prescribed drugs is reimbursed in an 136
210210 amount not to exceed t he lesser of the actual acquisition cost 137
211211 based on the Centers for Medicare and Medicaid Services National 138
212212 Average Drug Acquisition Cost pricing files plus a professional 139
213213 dispensing fee, the wholesale acquisition cost plus a 140
214214 professional dispensing fee, the state maximum allowable cost 141
215215 plus a professional dispensing fee, or the usual and customary 142
216216 charge billed by the provider. 143
217217 3. The agency shall develop and implement a process for 144
218218 managing the drug therapies of Medicaid recipients who are using 145
219219 significant numbers of prescribed drugs each month. The 146
220220 management process may include, but is not limited to, 147
221221 comprehensive, physician -directed medical-record reviews, claims 148
222222 analyses, and case evaluations to determine the medical 149
223223 necessity and appropriateness of a patient's treatment plan and 150
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232232 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
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236236 drug therapies. The agency may contract with a private 151
237237 organization to provide drug -program-management services. The 152
238238 Medicaid drug benefit management program shall include 153
239239 initiatives to manage drug therapies for HIV/AIDS pat ients, 154
240240 patients using 20 or more unique prescriptions in a 180 -day 155
241241 period, and the top 1,000 patients in annual spending. The 156
242242 agency shall enroll any Medicaid recipient in the drug benefit 157
243243 management program if he or she meets the specifications of this 158
244244 provision and is not enrolled in a Medicaid health maintenance 159
245245 organization. 160
246246 4. The agency may limit the size of its pharmacy network 161
247247 based on need, competitive bidding, price negotiations, 162
248248 credentialing, or similar criteria. The agency shall give 163
249249 special consideration to rural areas in determining the size and 164
250250 location of pharmacies included in the Medicaid pharmacy 165
251251 network. A pharmacy credentialing process may include criteria 166
252252 such as a pharmacy's full -service status, location, size, 167
253253 patient educational p rograms, patient consultation, disease 168
254254 management services, and other characteristics. The agency may 169
255255 impose a moratorium on Medicaid pharmacy enrollment if it is 170
256256 determined that it has a sufficient number of Medicaid -171
257257 participating providers. The agency mu st allow dispensing 172
258258 practitioners to participate as a part of the Medicaid pharmacy 173
259259 network regardless of the practitioner's proximity to any other 174
260260 entity that is dispensing prescription drugs under the Medicaid 175
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269269 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
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273273 program. A dispensing practitioner must meet all credentialing 176
274274 requirements applicable to his or her practice, as determined by 177
275275 the agency. 178
276276 5. The agency shall develop and implement a program that 179
277277 requires Medicaid practitioners who issue written prescriptions 180
278278 for medicinal drugs to use a counterf eit-proof prescription pad 181
279279 for Medicaid prescriptions. The agency shall require the use of 182
280280 standardized counterfeit -proof prescription pads by prescribers 183
281281 who issue written prescriptions for Medicaid recipients. The 184
282282 agency may implement the program in targ eted geographic areas or 185
283283 statewide. 186
284284 6. The agency may enter into arrangements that require 187
285285 manufacturers of generic drugs prescribed to Medicaid recipients 188
286286 to provide rebates of at least 15.1 percent of the average 189
287287 manufacturer price for the manufacturer 's generic products. 190
288288 These arrangements must shall require that if a generic -drug 191
289289 manufacturer pays federal rebates for Medicaid -reimbursed drugs 192
290290 at a level below 15.1 percent, the manufacturer must provide a 193
291291 supplemental rebate to the state in an amount n ecessary to 194
292292 achieve a 15.1-percent rebate level. 195
293293 7. The agency may establish a preferred drug list as 196
294294 described in this subsection, and, pursuant to the establishment 197
295295 of such preferred drug list, negotiate supplemental rebates from 198
296296 manufacturers that are in addition to those required by Title 199
297297 XIX of the Social Security Act and at no less than 14 percent of 200
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306306 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
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310310 the average manufacturer price as defined in 42 U.S.C. s. 1936 201
311311 on the last day of a quarter unless the federal or supplemental 202
312312 rebate, or both, equals or exceeds 29 percent. There is no upper 203
313313 limit on the supplemental rebates the agency may negotiate. The 204
314314 agency may determine that specific products, brand -name or 205
315315 generic, are competitive at lower rebate percentages. Agreement 206
316316 to pay the minimum supplemen tal rebate percentage guarantees a 207
317317 manufacturer that the Medicaid Pharmaceutical and Therapeutics 208
318318 Committee will consider a product for inclusion on the preferred 209
319319 drug list. However, a pharmaceutical manufacturer is not 210
320320 guaranteed placement on the preferre d drug list by simply paying 211
321321 the minimum supplemental rebate. Agency decisions will be made 212
322322 on the clinical efficacy of a drug and recommendations of the 213
323323 Medicaid Pharmaceutical and Therapeutics Committee, as well as 214
324324 the price of competing products minus f ederal and state rebates. 215
325325 The agency may contract with an outside agency or contractor to 216
326326 conduct negotiations for supplemental rebates. For the purposes 217
327327 of this section, the term "supplemental rebates" means cash 218
328328 rebates. Value-added programs as a substit ution for supplemental 219
329329 rebates are prohibited. The agency may seek any federal waivers 220
330330 to implement this initiative. 221
331331 8.a. The agency may implement a Medicaid behavioral drug 222
332332 management system. The agency may contract with a vendor that 223
333333 has experience in operating behavioral drug management systems 224
334334 to implement this program. The agency may seek federal waivers 225
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343343 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
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347347 to implement this program. 226
348348 b. The agency, in conjunction with the Department of 227
349349 Children and Families, may implement the Medicaid behavioral 228
350350 drug management system that is designed to improve the quality 229
351351 of care and behavioral health prescribing practices based on 230
352352 best practice guidelines, improve patient adherence to 231
353353 medication plans, reduce clinical risk, and lower prescribed 232
354354 drug costs and the ra te of inappropriate spending on Medicaid 233
355355 behavioral drugs. The program may include the following 234
356356 elements: 235
357357 (I) Provide for the development and adoption of best 236
358358 practice guidelines for behavioral health -related drugs such as 237
359359 antipsychotics, antidepressant s, and medications for treating 238
360360 bipolar disorders and other behavioral conditions; translate 239
361361 them into practice; review behavioral health prescribers and 240
362362 compare their prescribing patterns to a number of indicators 241
363363 that are based on national standards; and determine deviations 242
364364 from best practice guidelines. 243
365365 (II) Implement processes for providing feedback to and 244
366366 educating prescribers using best practice educational materials 245
367367 and peer-to-peer consultation. 246
368368 (III) Assess Medicaid beneficiaries who are outli ers in 247
369369 their use of behavioral health drugs with regard to the numbers 248
370370 and types of drugs taken, drug dosages, combination drug 249
371371 therapies, and other indicators of improper use of behavioral 250
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380380 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
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384384 health drugs. 251
385385 (IV) Alert prescribers to patients who fail to ref ill 252
386386 prescriptions in a timely fashion, are prescribed multiple same -253
387387 class behavioral health drugs, and may have other potential 254
388388 medication problems. 255
389389 (V) Track spending trends for behavioral health drugs and 256
390390 deviation from best practice guidelines. 257
391391 (VI) Use educational and technological approaches to 258
392392 promote best practices, educate consumers, and train prescribers 259
393393 in the use of practice guidelines. 260
394394 (VII) Disseminate electronic and published materials. 261
395395 (VIII) Hold statewide and regional conferences. 262
396396 (IX) Implement a disease management program with a model 263
397397 quality-based medication component for severely mentally ill 264
398398 individuals and emotionally disturbed children who are high 265
399399 users of care. 266
400400 9. The agency shall implement a Medicaid prescription drug 267
401401 management system. 268
402402 a. The agency may contract with a vendor that has 269
403403 experience in operating prescription drug management systems in 270
404404 order to implement this system. Any management system that is 271
405405 implemented in accordance with this subparagraph must rely o n 272
406406 cooperation between physicians and pharmacists to determine 273
407407 appropriate practice patterns and clinical guidelines to improve 274
408408 the prescribing, dispensing, and use of drugs in the Medicaid 275
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417417 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
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421421 program. The agency may seek federal waivers to implement this 276
422422 program. 277
423423 b. The drug management system must be designed to improve 278
424424 the quality of care and prescribing practices based on best 279
425425 practice guidelines, improve patient adherence to medication 280
426426 plans, reduce clinical risk, and lower prescribed drug costs and 281
427427 the rate of inappropriate spending on Medicaid prescription 282
428428 drugs. The program must: 283
429429 (I) Provide for the adoption of best practice guidelines 284
430430 for the prescribing and use of drugs in the Medicaid program, 285
431431 including translating best practice guidelines into pra ctice; 286
432432 reviewing prescriber patterns and comparing them to indicators 287
433433 that are based on national standards and practice patterns of 288
434434 clinical peers in their community, statewide, and nationally; 289
435435 and determine deviations from best practice guidelines. 290
436436 (II) Implement processes for providing feedback to and 291
437437 educating prescribers using best practice educational materials 292
438438 and peer-to-peer consultation. 293
439439 (III) Assess Medicaid recipients who are outliers in their 294
440440 use of a single or multiple prescription drugs wi th regard to 295
441441 the numbers and types of drugs taken, drug dosages, combination 296
442442 drug therapies, and other indicators of improper use of 297
443443 prescription drugs. 298
444444 (IV) Alert prescribers to recipients who fail to refill 299
445445 prescriptions in a timely fashion, are prescr ibed multiple drugs 300
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454454 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
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458458 that may be redundant or contraindicated, or may have other 301
459459 potential medication problems. 302
460460 10. The agency may contract for drug rebate 303
461461 administration, including, but not limited to, calculating 304
462462 rebate amounts, invoicing manufacturers, negotiating disputes 305
463463 with manufacturers, and maintaining a database of rebate 306
464464 collections. 307
465465 11. The agency may specify the preferred daily dosing form 308
466466 or strength for the purpose of promoting best practices with 309
467467 regard to the prescribing of certain drugs as specified in the 310
468468 General Appropriations Act and ensuring cost -effective 311
469469 prescribing practices. 312
470470 12. The agency may require prior authorization for 313
471471 Medicaid-covered prescribed drugs. The agency may prior -314
472472 authorize the use of a product: 315
473473 a. For an indication not approved in labeling; 316
474474 b. To comply with certain clinical guidelines; or 317
475475 c. If the product has the potential for overuse, misuse, 318
476476 or abuse. 319
477477 320
478478 The agency may require the prescribing professional to provide 321
479479 information about the rationale and su pporting medical evidence 322
480480 for the use of a drug. The agency shall post prior 323
481481 authorization, step-edit criteria and protocol, and updates to 324
482482 the list of drugs that are subject to prior authorization on the 325
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491491 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
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495495 agency's Internet website within 21 days after the prior 326
496496 authorization and step -edit criteria and protocol and updates 327
497497 are approved by the agency. For purposes of this subparagraph, 328
498498 the term "step-edit" means an automatic electronic review of 329
499499 certain medications subject to prior authorization. 330
500500 13. The agency, in conjunction with the Pharmaceutical and 331
501501 Therapeutics Committee, may require age -related prior 332
502502 authorizations for certain prescribed drugs. The agency may 333
503503 preauthorize the use of a drug for a recipient who may not meet 334
504504 the age requirement or may ex ceed the length of therapy for use 335
505505 of this product as recommended by the manufacturer and approved 336
506506 by the Food and Drug Administration. Prior authorization may 337
507507 require the prescribing professional to provide information 338
508508 about the rationale and supporting m edical evidence for the use 339
509509 of a drug. 340
510510 14. The agency shall implement a step -therapy prior 341
511511 authorization approval process for medications excluded from the 342
512512 preferred drug list. Medications listed on the preferred drug 343
513513 list must be used within the previou s 12 months before the 344
514514 alternative medications that are not listed. The step -therapy 345
515515 prior authorization may require the prescriber to use the 346
516516 medications of a similar drug class or for a similar medical 347
517517 indication unless contraindicated in the Food and Dr ug 348
518518 Administration labeling. The trial period between the specified 349
519519 steps may vary according to the medical indication. The step -350
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528528 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
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532532 therapy approval process must shall be developed in accordance 351
533533 with the committee as stated in s. 409.91195(7) and (8). A drug 352
534534 product may be approved or, in the case of a drug product for 353
535535 the treatment of a serious mental illness, must be approved 354
536536 without meeting the step -therapy prior authorization criteria if 355
537537 the prescribing physician provides the agency with additional 356
538538 written medical or clinical documentation that the product is 357
539539 medically necessary because: 358
540540 a. There is not a drug on the preferred drug list to treat 359
541541 the disease or medical condition which is an acceptable clinical 360
542542 alternative; 361
543543 b. The alternatives have been in effective in the treatment 362
544544 of the beneficiary's disease; 363
545545 c. The drug product or medication of a similar drug class 364
546546 is prescribed for the treatment of a serious mental illness 365
547547 schizophrenia or schizotypal or delusional disorders ; prior 366
548548 authorization has been granted previously for the prescribed 367
549549 drug; and the medication was dispensed to the patient during the 368
550550 previous 12 months; or 369
551551 d. Based on historical evidence and known characteristics 370
552552 of the patient and the drug, the drug is likely to be 371
553553 ineffective, or the number of doses have been ineffective. 372
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555555 The agency shall work with the physician to determine the best 374
556556 alternative for the patient. The agency may adopt rules waiving 375
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565565 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
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569569 the requirements for written clinical documentation for specific 376
570570 drugs in limited clinical situations. 377
571571 15. The agency shall implement a return and reuse program 378
572572 for drugs dispensed by pharmacies to institutional recipients, 379
573573 which includes payment of a $5 restocking fee for the 380
574574 implementation and operation of the program. The return a nd 381
575575 reuse program shall be implemented electronically and in a 382
576576 manner that promotes efficiency. The program must permit a 383
577577 pharmacy to exclude drugs from the program if it is not 384
578578 practical or cost-effective for the drug to be included and must 385
579579 provide for the return to inventory of drugs that cannot be 386
580580 credited or returned in a cost -effective manner. The agency 387
581581 shall determine if the program has reduced the amount of 388
582582 Medicaid prescription drugs which are destroyed on an annual 389
583583 basis and if there are additiona l ways to ensure more 390
584584 prescription drugs are not destroyed which could safely be 391
585585 reused. 392
586586 Section 3. Paragraph (a) of subsection (20) of section 393
587587 409.910, Florida Statutes, is amended to read: 394
588588 409.910 Responsibility for payments on behalf of Medicaid -395
589589 eligible persons when other parties are liable. — 396
590590 (20)(a) Entities providing health insurance as defined in 397
591591 s. 624.603, health maintenance organizations and prepaid health 398
592592 clinics as defined in chapter 641, and, on behalf of their 399
593593 clients, third-party administrators, pharmacy benefits managers, 400
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602602 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
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604604
605605
606606 and any other third parties, as defined in s. 409.901 s. 401
607607 409.901(27), which are legally responsible for payment of a 402
608608 claim for a health care item or service as a condition of doing 403
609609 business in the state or providing coverage to residents of the 404
610610 this state, shall provide such records and information as are 405
611611 necessary to accomplish the purpose of this section, unless such 406
612612 requirement results in an unreasonable burden. 407
613613 Section 4. The Agency for Health Care Administrat ion is 408
614614 directed to include the rate impact of this act in the Medicaid 409
615615 managed medical assistance program and long -term care managed 410
616616 care program rates that become effective on October 1, 2024. 411
617617 Section 5. This act shall take effect October 1, 2024. 412