Florida 2022 Regular Session

Florida House Bill H0885 Compare Versions

Only one version of the bill is available at this time.

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3	3	HB 885 2022
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10	10	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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14	14	A bill to be entitled 1
15	15	An act relating to prescription drugs used in the 2
16	16	treatment of schizophrenia for Medicaid recipients; 3
17	17	amending s. 409.912, F.S.; authorizing the approval of 4
18	18	drug products or certain medication prescribed for the 5
19	19	treatment of schizophrenia or schizotypal or 6
20	20	delusional disorders for Medicaid recipients who have 7
21	21	not met the step-therapy prior authorization criteria, 8
22	22	when the drug product or certain medication meets 9
23	23	specified criteria; providing an effective date. 10
24	24	11
25	25	Be It Enacted by the Legislature of the State of Florida: 12
26	26	13
27	27	Section 1. Paragraph (a) of subsection (5) of section 14
28	28	409.912, Florida Statutes, is amended to read: 15
29	29	409.912 Cost-effective purchasing of health care.—The 16
30	30	agency shall purchase goods and services for Medicaid recipients 17
31	31	in the most cost-effective manner consistent with the delivery 18
32	32	of quality medical care. To ensure that medical services are 19
33	33	effectively utilized, the agency may, in any case, require a 20
34	34	confirmation or second physician's opinion of the correct 21
35	35	diagnosis for purposes of authorizing future services under the 22
36	36	Medicaid program. This section does not restrict access to 23
37	37	emergency services or poststabilization care services as defined 24
38	38	in 42 C.F.R. s. 438.114. Such confirmation or second opinion 25
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47	47	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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51	51	shall be rendered in a manner approved by the agency. The agency 26
52	52	shall maximize the use of prepaid per capita and prepaid 27
53	53	aggregate fixed-sum basis services when appropriate and other 28
54	54	alternative service delivery and reimbursement methodologies, 29
55	55	including competitive bidding pursuant to s. 287.057, designed 30
56	56	to facilitate the cost -effective purchase of a case -managed 31
57	57	continuum of care. The agency shall also require providers to 32
58	58	minimize the exposure of recipients to the need for acute 33
59	59	inpatient, custodial, and other institutional care and the 34
60	60	inappropriate or unnecessary use of high -cost services. The 35
61	61	agency shall contract with a vendor to monitor and evaluate the 36
62	62	clinical practice patterns of prov iders in order to identify 37
63	63	trends that are outside the normal practice patterns of a 38
64	64	provider's professional peers or the national guidelines of a 39
65	65	provider's professional association. The vendor must be able to 40
66	66	provide information and counseling to a provi der whose practice 41
67	67	patterns are outside the norms, in consultation with the agency, 42
68	68	to improve patient care and reduce inappropriate utilization. 43
69	69	The agency may mandate prior authorization, drug therapy 44
70	70	management, or disease management participation for c ertain 45
71	71	populations of Medicaid beneficiaries, certain drug classes, or 46
72	72	particular drugs to prevent fraud, abuse, overuse, and possible 47
73	73	dangerous drug interactions. The Pharmaceutical and Therapeutics 48
74	74	Committee shall make recommendations to the agency on dr ugs for 49
75	75	which prior authorization is required. The agency shall inform 50
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84	84	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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88	88	the Pharmaceutical and Therapeutics Committee of its decisions 51
89	89	regarding drugs subject to prior authorization. The agency is 52
90	90	authorized to limit the entities it contracts with or enroll s as 53
91	91	Medicaid providers by developing a provider network through 54
92	92	provider credentialing. The agency may competitively bid single -55
93	93	source-provider contracts if procurement of goods or services 56
94	94	results in demonstrated cost savings to the state without 57
95	95	limiting access to care. The agency may limit its network based 58
96	96	on the assessment of beneficiary access to care, provider 59
97	97	availability, provider quality standards, time and distance 60
98	98	standards for access to care, the cultural competence of the 61
99	99	provider network, de mographic characteristics of Medicaid 62
100	100	beneficiaries, practice and provider -to-beneficiary standards, 63
101	101	appointment wait times, beneficiary use of services, provider 64
102	102	turnover, provider profiling, provider licensure history, 65
103	103	previous program integrity investig ations and findings, peer 66
104	104	review, provider Medicaid policy and billing compliance records, 67
105	105	clinical and medical record audits, and other factors. Providers 68
106	106	are not entitled to enrollment in the Medicaid provider network. 69
107	107	The agency shall determine instance s in which allowing Medicaid 70
108	108	beneficiaries to purchase durable medical equipment and other 71
109	109	goods is less expensive to the Medicaid program than long -term 72
110	110	rental of the equipment or goods. The agency may establish rules 73
111	111	to facilitate purchases in lieu of lo ng-term rentals in order to 74
112	112	protect against fraud and abuse in the Medicaid program as 75
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121	121	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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125	125	defined in s. 409.913. The agency may seek federal waivers 76
126	126	necessary to administer these policies. 77
127	127	(5)(a) The agency shall implement a Medicaid prescribed -78
128	128	drug spending-control program that includes the following 79
129	129	components: 80
130	130	1. A Medicaid preferred drug list, which shall be a 81
131	131	listing of cost-effective therapeutic options recommended by the 82
132	132	Medicaid Pharmacy and Therapeutics Committee established 83
133	133	pursuant to s. 409.911 95 and adopted by the agency for each 84
134	134	therapeutic class on the preferred drug list. At the discretion 85
135	135	of the committee, and when feasible, the preferred drug list 86
136	136	should include at least two products in a therapeutic class. The 87
137	137	agency may post the preferre d drug list and updates to the list 88
138	138	on an Internet website without following the rulemaking 89
139	139	procedures of chapter 120. Antiretroviral agents are excluded 90
140	140	from the preferred drug list. The agency shall also limit the 91
141	141	amount of a prescribed drug dispensed to no more than a 34-day 92
142	142	supply unless the drug products' smallest marketed package is 93
143	143	greater than a 34-day supply, or the drug is determined by the 94
144	144	agency to be a maintenance drug in which case a 100 -day maximum 95
145	145	supply may be authorized. The agency may see k any federal 96
146	146	waivers necessary to implement these cost -control programs and 97
147	147	to continue participation in the federal Medicaid rebate 98
148	148	program, or alternatively to negotiate state -only manufacturer 99
149	149	rebates. The agency may adopt rules to administer this 100
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158	158	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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160	160
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162	162	subparagraph. The agency shall continue to provide unlimited 101
163	163	contraceptive drugs and items. The agency must establish 102
164	164	procedures to ensure that: 103
165	165	a. There is a response to a request for prior 104
166	166	authorization by telephone or other telecommunication device 105
167	167	within 24 hours after receipt of a request for prior 106
168	168	authorization; and 107
169	169	b. A 72-hour supply of the drug prescribed is provided in 108
170	170	an emergency or when the agency does not provide a response 109
171	171	within 24 hours as required by sub -subparagraph a. 110
172	172	2. A provider of prescribed drugs is reimbursed in an 111
173	173	amount not to exceed the lesser of the actual acquisition cost 112
174	174	based on the Centers for Medicare and Medicaid Services National 113
175	175	Average Drug Acquisition Cost pricing files plus a professional 114
176	176	dispensing fee, the wholesa le acquisition cost plus a 115
177	177	professional dispensing fee, the state maximum allowable cost 116
178	178	plus a professional dispensing fee, or the usual and customary 117
179	179	charge billed by the provider. 118
180	180	3. The agency shall develop and implement a process for 119
181	181	managing the drug therapies of Medicaid recipients who are using 120
182	182	significant numbers of prescribed drugs each month. The 121
183	183	management process may include, but is not limited to, 122
184	184	comprehensive, physician -directed medical-record reviews, claims 123
185	185	analyses, and case evaluations to determine the medical 124
186	186	necessity and appropriateness of a patient's treatment plan and 125
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195	195	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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197	197
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199	199	drug therapies. The agency may contract with a private 126
200	200	organization to provide drug -program-management services. The 127
201	201	Medicaid drug benefit management program shall in clude 128
202	202	initiatives to manage drug therapies for HIV/AIDS patients, 129
203	203	patients using 20 or more unique prescriptions in a 180 -day 130
204	204	period, and the top 1,000 patients in annual spending. The 131
205	205	agency shall enroll any Medicaid recipient in the drug benefit 132
206	206	management program if he or she meets the specifications of this 133
207	207	provision and is not enrolled in a Medicaid health maintenance 134
208	208	organization. 135
209	209	4. The agency may limit the size of its pharmacy network 136
210	210	based on need, competitive bidding, price negotiations, 137
211	211	credentialing, or similar criteria. The agency shall give 138
212	212	special consideration to rural areas in determining the size and 139
213	213	location of pharmacies included in the Medicaid pharmacy 140
214	214	network. A pharmacy credentialing process may include criteria 141
215	215	such as a pharmacy's full-service status, location, size, 142
216	216	patient educational programs, patient consultation, disease 143
217	217	management services, and other characteristics. The agency may 144
218	218	impose a moratorium on Medicaid pharmacy enrollment if it is 145
219	219	determined that it has a sufficien t number of Medicaid -146
220	220	participating providers. The agency must allow dispensing 147
221	221	practitioners to participate as a part of the Medicaid pharmacy 148
222	222	network regardless of the practitioner's proximity to any other 149
223	223	entity that is dispensing prescription drugs unde r the Medicaid 150
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232	232	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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236	236	program. A dispensing practitioner must meet all credentialing 151
237	237	requirements applicable to his or her practice, as determined by 152
238	238	the agency. 153
239	239	5. The agency shall develop and implement a program that 154
240	240	requires Medicaid practitioners who issue written prescriptions 155
241	241	for medicinal drugs to use a counterfeit -proof prescription pad 156
242	242	for Medicaid prescriptions. The agency shall require the use of 157
243	243	standardized counterfeit -proof prescription pads by prescribers 158
244	244	who issue written prescriptions for Medica id recipients. The 159
245	245	agency may implement the program in targeted geographic areas or 160
246	246	statewide. 161
247	247	6. The agency may enter into arrangements that require 162
248	248	manufacturers of generic drugs prescribed to Medicaid recipients 163
249	249	to provide rebates of at least 15.1 per cent of the average 164
250	250	manufacturer price for the manufacturer's generic products. 165
251	251	These arrangements shall require that if a generic -drug 166
252	252	manufacturer pays federal rebates for Medicaid -reimbursed drugs 167
253	253	at a level below 15.1 percent, the manufacturer must pro vide a 168
254	254	supplemental rebate to the state in an amount necessary to 169
255	255	achieve a 15.1-percent rebate level. 170
256	256	7. The agency may establish a preferred drug list as 171
257	257	described in this subsection, and, pursuant to the establishment 172
258	258	of such preferred drug list, nego tiate supplemental rebates from 173
259	259	manufacturers that are in addition to those required by Title 174
260	260	XIX of the Social Security Act and at no less than 14 percent of 175
261	261
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269	269	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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273	273	the average manufacturer price as defined in 42 U.S.C. s. 1936 176
274	274	on the last day of a quarter unles s the federal or supplemental 177
275	275	rebate, or both, equals or exceeds 29 percent. There is no upper 178
276	276	limit on the supplemental rebates the agency may negotiate. The 179
277	277	agency may determine that specific products, brand -name or 180
278	278	generic, are competitive at lower reba te percentages. Agreement 181
279	279	to pay the minimum supplemental rebate percentage guarantees a 182
280	280	manufacturer that the Medicaid Pharmaceutical and Therapeutics 183
281	281	Committee will consider a product for inclusion on the preferred 184
282	282	drug list. However, a pharmaceutical ma nufacturer is not 185
283	283	guaranteed placement on the preferred drug list by simply paying 186
284	284	the minimum supplemental rebate. Agency decisions will be made 187
285	285	on the clinical efficacy of a drug and recommendations of the 188
286	286	Medicaid Pharmaceutical and Therapeutics Committ ee, as well as 189
287	287	the price of competing products minus federal and state rebates. 190
288	288	The agency may contract with an outside agency or contractor to 191
289	289	conduct negotiations for supplemental rebates. For the purposes 192
290	290	of this section, the term "supplemental rebates" means cash 193
291	291	rebates. Value-added programs as a substitution for supplemental 194
292	292	rebates are prohibited. The agency may seek any federal waivers 195
293	293	to implement this initiative. 196
294	294	8.a. The agency may implement a Medicaid behavioral drug 197
295	295	management system. The age ncy may contract with a vendor that 198
296	296	has experience in operating behavioral drug management systems 199
297	297	to implement this program. The agency may seek federal waivers 200
298	298
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306	306	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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308	308
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310	310	to implement this program. 201
311	311	b. The agency, in conjunction with the Department of 202
312	312	Children and Families, may implement the Medicaid behavioral 203
313	313	drug management system that is designed to improve the quality 204
314	314	of care and behavioral health prescribing practices based on 205
315	315	best practice guidelines, improve patient adherence to 206
316	316	medication plans, reduce cli nical risk, and lower prescribed 207
317	317	drug costs and the rate of inappropriate spending on Medicaid 208
318	318	behavioral drugs. The program may include the following 209
319	319	elements: 210
320	320	(I) Provide for the development and adoption of best 211
321	321	practice guidelines for behavioral healt h-related drugs such as 212
322	322	antipsychotics, antidepressants, and medications for treating 213
323	323	bipolar disorders and other behavioral conditions; translate 214
324	324	them into practice; review behavioral health prescribers and 215
325	325	compare their prescribing patterns to a number o f indicators 216
326	326	that are based on national standards; and determine deviations 217
327	327	from best practice guidelines. 218
328	328	(II) Implement processes for providing feedback to and 219
329	329	educating prescribers using best practice educational materials 220
330	330	and peer-to-peer consultation. 221
331	331	(III) Assess Medicaid beneficiaries who are outliers in 222
332	332	their use of behavioral health drugs with regard to the numbers 223
333	333	and types of drugs taken, drug dosages, combination drug 224
334	334	therapies, and other indicators of improper use of behavioral 225
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343	343	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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347	347	health drugs. 226
348	348	(IV) Alert prescribers to patients who fail to refill 227
349	349	prescriptions in a timely fashion, are prescribed multiple same -228
350	350	class behavioral health drugs, and may have other potential 229
351	351	medication problems. 230
352	352	(V) Track spending trends for behavioral health dru gs and 231
353	353	deviation from best practice guidelines. 232
354	354	(VI) Use educational and technological approaches to 233
355	355	promote best practices, educate consumers, and train prescribers 234
356	356	in the use of practice guidelines. 235
357	357	(VII) Disseminate electronic and published material s. 236
358	358	(VIII) Hold statewide and regional conferences. 237
359	359	(IX) Implement a disease management program with a model 238
360	360	quality-based medication component for severely mentally ill 239
361	361	individuals and emotionally disturbed children who are high 240
362	362	users of care. 241
363	363	9. The agency shall implement a Medicaid prescription drug 242
364	364	management system. 243
365	365	a. The agency may contract with a vendor that has 244
366	366	experience in operating prescription drug management systems in 245
367	367	order to implement this system. Any management system that is 246
368	368	implemented in accordance with this subparagraph must rely on 247
369	369	cooperation between physicians and pharmacists to determine 248
370	370	appropriate practice patterns and clinical guidelines to improve 249
371	371	the prescribing, dispensing, and use of drugs in the Medicaid 250
372	372
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380	380	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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382	382
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384	384	program. The agency may seek federal waivers to implement this 251
385	385	program. 252
386	386	b. The drug management system must be designed to improve 253
387	387	the quality of care and prescribing practices based on best 254
388	388	practice guidelines, improve patient adherence to medication 255
389	389	plans, reduce clinical risk, and lower prescribed drug costs and 256
390	390	the rate of inappropriate spending on Medicaid prescription 257
391	391	drugs. The program must: 258
392	392	(I) Provide for the adoption of best practice guidelines 259
393	393	for the prescribing and use of drugs in the Medicaid program, 260
394	394	including translating best practice guidelines into practice; 261
395	395	reviewing prescriber patterns and comparing them to indicators 262
396	396	that are based on national standards and practice patterns of 263
397	397	clinical peers in their community, statewide, and nationally; 264
398	398	and determine deviations from best practice guidelines. 265
399	399	(II) Implement processes for providing feedback to and 266
400	400	educating prescribers using best practice educational materials 267
401	401	and peer-to-peer consultation. 268
402	402	(III) Assess Medicaid recipients who are outliers in t heir 269
403	403	use of a single or multiple prescription drugs with regard to 270
404	404	the numbers and types of drugs taken, drug dosages, combination 271
405	405	drug therapies, and other indicators of improper use of 272
406	406	prescription drugs. 273
407	407	(IV) Alert prescribers to recipients who fail t o refill 274
408	408	prescriptions in a timely fashion, are prescribed multiple drugs 275
409	409
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417	417	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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421	421	that may be redundant or contraindicated, or may have other 276
422	422	potential medication problems. 277
423	423	10. The agency may contract for drug rebate 278
424	424	administration, including, but not limited to , calculating 279
425	425	rebate amounts, invoicing manufacturers, negotiating disputes 280
426	426	with manufacturers, and maintaining a database of rebate 281
427	427	collections. 282
428	428	11. The agency may specify the preferred daily dosing form 283
429	429	or strength for the purpose of promoting best pra ctices with 284
430	430	regard to the prescribing of certain drugs as specified in the 285
431	431	General Appropriations Act and ensuring cost -effective 286
432	432	prescribing practices. 287
433	433	12. The agency may require prior authorization for 288
434	434	Medicaid-covered prescribed drugs. The agency may prior-289
435	435	authorize the use of a product: 290
436	436	a. For an indication not approved in labeling; 291
437	437	b. To comply with certain clinical guidelines; or 292
438	438	c. If the product has the potential for overuse, misuse, 293
439	439	or abuse. 294
440	440	295
441	441	The agency may require the prescribing professi onal to provide 296
442	442	information about the rationale and supporting medical evidence 297
443	443	for the use of a drug. The agency shall post prior 298
444	444	authorization, step-edit criteria and protocol, and updates to 299
445	445	the list of drugs that are subject to prior authorization on t he 300
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454	454	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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457	457
458	458	agency's Internet website within 21 days after the prior 301
459	459	authorization and step -edit criteria and protocol and updates 302
460	460	are approved by the agency. For purposes of this subparagraph, 303
461	461	the term "step-edit" means an automatic electronic review of 304
462	462	certain medications subject to prior authorization. 305
463	463	13. The agency, in conjunction with the Pharmaceutical and 306
464	464	Therapeutics Committee, may require age -related prior 307
465	465	authorizations for certain prescribed drugs. The agency may 308
466	466	preauthorize the use of a drug for a re cipient who may not meet 309
467	467	the age requirement or may exceed the length of therapy for use 310
468	468	of this product as recommended by the manufacturer and approved 311
469	469	by the Food and Drug Administration. Prior authorization may 312
470	470	require the prescribing professional to pr ovide information 313
471	471	about the rationale and supporting medical evidence for the use 314
472	472	of a drug. 315
473	473	14. The agency shall implement a step -therapy prior 316
474	474	authorization approval process for medications excluded from the 317
475	475	preferred drug list. Medications listed on t he preferred drug 318
476	476	list must be used within the previous 12 months before the 319
477	477	alternative medications that are not listed. The step -therapy 320
478	478	prior authorization may require the prescriber to use the 321
479	479	medications of a similar drug class or for a similar medica l 322
480	480	indication unless contraindicated in the Food and Drug 323
481	481	Administration labeling. The trial period between the specified 324
482	482	steps may vary according to the medical indication. The step -325
483	483
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491	491	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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494	494
495	495	therapy approval process shall be developed in accordance with 326
496	496	the committee as stated in s. 409.91195(7) and (8). A drug 327
497	497	product may be approved without meeting the step -therapy prior 328
498	498	authorization criteria if the prescribing physician provides the 329
499	499	agency with additional written medical or clinical documentation 330
500	500	that the product is medically necessary because: 331
501	501	a. There is not a drug on the preferred drug list to treat 332
502	502	the disease or medical condition which is an acceptable clinical 333
503	503	alternative; 334
504	504	b. The alternatives have been ineffective in the treatment 335
505	505	of the beneficiary's d isease; or 336
506	506	c. The drug product or medication of a similar drug class 337
507	507	is prescribed for the treatment of schizophrenia or schizotypal 338
508	508	or delusional disorders; prior authorization has been granted 339
509	509	previously for the prescribed drug; and the medication was 340
510	510	dispensed to the patient during the previous 12 months; or 341
511	511	d. Based on historic evidence and known characteristics of 342
512	512	the patient and the drug, the drug is likely to be ineffective, 343
513	513	or the number of doses have been ineffective. 344
514	514	345
515	515	The agency shall work wit h the physician to determine the best 346
516	516	alternative for the patient. The agency may adopt rules waiving 347
517	517	the requirements for written clinical documentation for specific 348
518	518	drugs in limited clinical situations. 349
519	519	15. The agency shall implement a return and reuse program 350
520	520
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528	528	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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532	532	for drugs dispensed by pharmacies to institutional recipients, 351
533	533	which includes payment of a $5 restocking fee for the 352
534	534	implementation and operation of the program. The return and 353
535	535	reuse program shall be implemented electronically and in a 354
536	536	manner that promotes efficiency. The program must permit a 355
537	537	pharmacy to exclude drugs from the program if it is not 356
538	538	practical or cost-effective for the drug to be included and must 357
539	539	provide for the return to inventory of drugs that cannot be 358
540	540	credited or returned in a c ost-effective manner. The agency 359
541	541	shall determine if the program has reduced the amount of 360
542	542	Medicaid prescription drugs which are destroyed on an annual 361
543	543	basis and if there are additional ways to ensure more 362
544	544	prescription drugs are not destroyed which could sa fely be 363
545	545	reused. 364
546	546	Section 2. This act shall take effect July 1, 2022. 365