Florida 2022 Regular Session

Florida House Bill H1183 Compare Versions

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

Old	New	Differences
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2	2
3	3	HB 1183 2022
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5	5
6	6
7	7	CODING: Words stricken are deletions; words underlined are additions.
8	8	hb1183-00
9	9	Page 1 of 43
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
11	11
12	12
13	13
14	14	A bill to be entitled 1
15	15	An act relating to prescription drug price 2
16	16	transparency; amending s. 499.012, F.S.; prohibiting 3
17	17	permits for prescription drug manufacturers and 4
18	18	nonresident prescription drug manufacturers and for 5
19	19	certain wholesale distributors of prescription drugs 6
20	20	from being renewed unless specified requirements are 7
21	21	met; authorizing the Department of Business and 8
22	22	Professional Regulation to suspend or revoke 9
23	23	manufacturer permits and wholesale distributor permits 10
24	24	under specified circumstances; amending s. 499.0121, 11
25	25	F.S.; defining the term "price"; providing reporting 12
26	26	requirements for certain entities that engage in 13
27	27	wholesale distributions of prescription drugs; 14
28	28	authorizing the department to request certain 15
29	29	documentation and information; requiring the 16
30	30	department to prescribe b y rule specified timeframes; 17
31	31	authorizing the department to extend specified 18
32	32	timeframes; specifying what constitutes violations of 19
33	33	specified laws; providing penalties and fines for 20
34	34	violations; providing disposition of such fines; 21
35	35	creating s. 499.026, F.S.; providing definitions; 22
36	36	providing requirements for notifications by 23
37	37	manufacturers of prescription drug price increases 24
38	38	under certain circumstances; providing reporting 25
39	39
40	40	HB 1183 2022
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42	42
43	43
44	44	CODING: Words stricken are deletions; words underlined are additions.
45	45	hb1183-00
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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
48	48
49	49
50	50
51	51	requirements; requiring the department to compile a 26
52	52	list of specified drugs; authorizing the department to 27
53	53	request certain documentation and information; 28
54	54	requiring the department to prescribe by rule 29
55	55	specified timeframes; authorizing the department to 30
56	56	extend specified timeframes; providing duties of the 31
57	57	department; specifying what constitutes violations of 32
58	58	specified laws; prohibiting certain prescription drugs 33
59	59	from being included in specified drug formularies; 34
60	60	providing an exception; providing penalties and fines 35
61	61	for violations; providing disposition of such fines; 36
62	62	requiring the department to a dopt rules; amending s. 37
63	63	499.05, F.S.; requiring the department to adopt rules; 38
64	64	conforming provisions to changes made by the act; 39
65	65	amending s. 624.490, F.S.; providing definitions; 40
66	66	providing reporting requirements for registered 41
67	67	pharmacy benefit managers; au thorizing the Office of 42
68	68	Insurance Regulation to request certain documentation 43
69	69	and information; requiring the Financial Services 44
70	70	Commission to prescribe by rule specified timeframes; 45
71	71	authorizing the office to extend specified timeframes; 46
72	72	requiring registered pharmacy benefit managers to 47
73	73	maintain a website for a specified purpose and to 48
74	74	update the information on the website under certain 49
75	75	circumstances; specifying what constitutes violations 50
76	76
77	77	HB 1183 2022
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79	79
80	80
81	81	CODING: Words stricken are deletions; words underlined are additions.
82	82	hb1183-00
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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
85	85
86	86
87	87
88	88	of specified laws; providing penalties and fines for 51
89	89	violations; providing disposition of such fines; 52
90	90	creating ss. 627.42384 and 641.3131, F.S.; requiring 53
91	91	certain health insurers and health maintenance 54
92	92	organizations, respectively, to submit and update 55
93	93	contact information for single points of contact for a 56
94	94	specified use; requiring the office to maintain and 57
95	95	publish such points of contact; requiring such health 58
96	96	insurers and health maintenance organizations to 59
97	97	notify certain insureds and subscribers, respectively, 60
98	98	within a specified timeframe of drug formulary 61
99	99	changes; providing applicability; amending ss. 62
100	100	627.64741, 627.6572, and 641.314, F.S.; defining the 63
101	101	term "net price"; providing additional requirements 64
102	102	for contracts between pharmacy benefit managers and 65
103	103	individual health insurers, group health insurers, and 66
104	104	health maintenance organizations, respectively; 67
105	105	providing applicability; amending ss. 110.12315, 68
106	106	409.815, 409.91195, 409.912, and 499.067, F.S.; 69
107	107	conforming provisions to changes made by the act; 70
108	108	providing an effective date. 71
109	109	72
110	110	Be It Enacted by the Legislature of the S tate of Florida: 73
111	111	74
112	112	Section 1. Paragraph (f) is added to subsection (1) of 75
113	113
114	114	HB 1183 2022
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116	116
117	117
118	118	CODING: Words stricken are deletions; words underlined are additions.
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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
122	122
123	123
124	124
125	125	section 499.012, Florida Statutes, to read: 76
126	126	499.012 Permit application requirements. — 77
127	127	(1) 78
128	128	(f)1. A permit for a prescription drug manufacturer or 79
129	129	nonresident prescription drug manufacturer may not be renewed 80
130	130	unless the prescription drug manufacturer or nonresident 81
131	131	prescription drug manufacturer meets the requirements of s. 82
132	132	499.026. The department may suspend or revoke the permit of a 83
133	133	manufacturer that fails to comply with the r equirements of s. 84
134	134	499.026. 85
135	135	2. A permit for a prescription drug wholesale distributor, 86
136	136	out-of-state prescription drug wholesale distributor, retail 87
137	137	pharmacy drug wholesale distributor, veterinary prescription 88
138	138	drug wholesale distributor, or limited prescri ption drug 89
139	139	veterinary wholesale distributor may not be renewed unless the 90
140	140	wholesale distributor meets the requirements of s. 499.0121(16). 91
141	141	The department may suspend or revoke the permit of a wholesale 92
142	142	distributor that fails to comply with the requirements of s. 93
143	143	499.0121(16). 94
144	144	Section 2. Subsection (16) is added to section 499.0121, 95
145	145	Florida Statutes, to read: 96
146	146	499.0121 Storage and handling of prescription drugs; 97
147	147	recordkeeping; prescription drug price report requirements; 98
148	148	penalties for noncompliance .—The department shall adopt rules to 99
149	149	implement this section as necessary to protect the public 100
150	150
151	151	HB 1183 2022
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153	153
154	154
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156	156	hb1183-00
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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
159	159
160	160
161	161
162	162	health, safety, and welfare. Such rules shall include, but not 101
163	163	be limited to, requirements for the storage and handling of 102
164	164	prescription drugs and for the establishme nt and maintenance of 103
165	165	prescription drug distribution records. 104
166	166	(16) PRESCRIPTION DRUG PRICE REPORT AND PENALTIES FOR 105
167	167	NONCOMPLIANCE.— 106
168	168	(a) As used in this subsection, the term "price" means the 107
169	169	manufacturer's list price for a prescription drug to wholesal ers 108
170	170	or direct purchasers in the United States, not including prompt 109
171	171	pay or other discounts, rebates, or reductions in price, for the 110
172	172	most recent month for which the information is available, as 111
173	173	reported in wholesale price guides or other publications of dr ug 112
174	174	or biological pricing data. 113
175	175	(b) By July 1 of each year, each prescription drug 114
176	176	wholesale distributor, out -of-state prescription drug wholesale 115
177	177	distributor, retail pharmacy drug wholesale distributor, 116
178	178	prescription drug wholesale distributor, veterinary prescription 117
179	179	drug wholesale distributor, or limited prescription drug 118
180	180	veterinary wholesale distributor, or each manufacturer or 119
181	181	repackager that engages in the wholesale distribution of 120
182	182	prescription drugs, shall submit a report to the department on 121
183	183	each prescription drug for which the price, during the previous 122
184	184	calendar year: 123
185	185	1. Was $100 or more for a 30 -day supply or for a course of 124
186	186	treatment lasting less than 30 days; or 125
187	187
188	188	HB 1183 2022
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191	191
192	192	CODING: Words stricken are deletions; words underlined are additions.
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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
198	198
199	199	2. Increased by at least 10 percent over the previous 126
200	200	price. 127
201	201	(c) The report must include, at a minimum, the following 128
202	202	information: 129
203	203	1. The name and the price at the time of the report of 130
204	204	each prescription drug specified in paragraph (b) and the 131
205	205	cumulative percentage price increase during the previous 132
206	206	calendar year. 133
207	207	2. The length of time the prescription drug has been on 134
208	208	the market. 135
209	209	3. The factors that contributed to the price increase. 136
210	210	4. The name of any generic version of the prescription drug 137
211	211	available on the market. 138
212	212	5. The total sales revenue for the prescription drug 139
213	213	during the previous calendar year. 140
214	214	6. The introductory price of the prescription drug when it 141
215	215	was approved by the United States Food and Drug Administration 142
216	216	and the cumulative yearly increase, by calendar year, in the 143
217	217	price of the drug during the previous 5 years or during the 144
218	218	number of years the drug has been on the market, whichever is 145
219	219	less. 146
220	220	7. Any prompt pay or discount, rebate, or reduction in 147
221	221	price provided by the reporting wholesale distributor or 148
222	222	manufacturer or repackager that engages in the wholesa le 149
223	223	distribution of prescription drugs when selling a prescription 150
224	224
225	225	HB 1183 2022
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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
233	233
234	234
235	235
236	236	drug to a manufacturer, pharmacy, pharmacy benefit manager, and 151
237	237	other entities. 152
238	238	8. The documentation necessary to support the information 153
239	239	reported under this paragraph. 154
240	240	(d) The department may make a written request to the 155
241	241	reporting wholesale distributor, manufacturer, or repackager for 156
242	242	supporting documentation or additional information concerning 157
243	243	the report. The department shall prescribe by rule the 158
244	244	timeframes for the department's reques t for documentation or 159
245	245	information and for the response by the reporting wholesale 160
246	246	distributor, manufacturer, or repackager. The department may 161
247	247	extend the timeframe, if necessary, for the response by the 162
248	248	wholesale distributor, manufacturer, or repackager. 163
249	249	(e) A wholesale distributor, or a manufacturer or 164
250	250	repackager that engages in the wholesale distribution of 165
251	251	prescription drugs, violates this subsection if the wholesale 166
252	252	distributor, manufacturer, or repackager: 167
253	253	1. Fails to timely submit the report requ ired under this 168
254	254	subsection; 169
255	255	2. Fails to provide information required under this 170
256	256	subsection; 171
257	257	3. Fails to timely respond to a written request by the 172
258	258	department with regard to the report required under this 173
259	259	subsection; or 174
260	260	4. Provides inaccurate or incom plete information in the 175
261	261
262	262	HB 1183 2022
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264	264
265	265
266	266	CODING: Words stricken are deletions; words underlined are additions.
267	267	hb1183-00
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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
270	270
271	271
272	272
273	273	report required under this subsection. 176
274	274	(f)1. The department may deny an application for a renewal 177
275	275	permit or registration or suspend or revoke a registration 178
276	276	certificate or a permit of a prescription drug wholesale 179
277	277	distributor, or a manufacturer or repackager that engages in the 180
278	278	wholesale distribution of prescription drugs, for violating this 181
279	279	subsection. 182
280	280	2.a. The department may also impose an administrative 183
281	281	fine, not to exceed $5,000 per violation per day, for a 184
282	282	violation of this subsection or a rule adopted to administer 185
283	283	this subsection. Each day the violation continues constitutes a 186
284	284	separate violation, and each such separate violation is subject 187
285	285	to a separate fine. 188
286	286	b. In determining the amount of fine to be levied for a 189
287	287	violation of this subsection, the department must consider the 190
288	288	following factors: 191
289	289	(I) The severity of the violation. 192
290	290	(II) Any action taken by the permittee to correct the 193
291	291	violation or to remedy complaints. 194
292	292	(III) Any previous violation. 195
293	293	c. All fines collected under this subparagraph shall be 196
294	294	deposited into the Public Medical Assistance Trust Fund 197
295	295	administered by the Agency for Health Care Administration, to be 198
296	296	used to help the uninsured pay for health care. 199
297	297	Section 3. Section 499.026, Florida Statutes, is created 200
298	298
299	299	HB 1183 2022
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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
307	307
308	308
309	309
310	310	to read: 201
311	311	499.026 Prescription drug price transparency. — 202
312	312	(1) As used in this section, the term: 203
313	313	(a) "Agency" means the Agency for Health Care 204
314	314	Administration. 205
315	315	(b) "Division" means the Division of Consumer Services of 206
316	316	the Department of Agr iculture and Consumer Services. 207
317	317	(c) "Drug" means a prescription drug. 208
318	318	(d) "Health insurer" means a health insurer issuing major 209
319	319	medical coverage through an individual or group policy or a 210
320	320	health maintenance organization issuing major medical coverage 211
321	321	through an individual or group contract, regulated under chapter 212
322	322	627 or chapter 641. 213
323	323	(e) "Medicaid" means the Agency for Health Care 214
324	324	Administration Medicaid program. 215
325	325	(f) "Office" means the Office of Insurance Regulation of 216
326	326	the Financial Services Commission. 217
327	327	(g) "Price" means the manufacturer's list price for a drug 218
328	328	to wholesalers or direct purchasers in the United States, not 219
329	329	including prompt pay or other discounts, rebates, or reductions 220
330	330	in price, for the most recent month for which the informa tion is 221
331	331	available, as reported in wholesale price guides or other 222
332	332	publications of drug or biological pricing data. 223
333	333	(2)(a) At least 120 days before the effective date of any 224
334	334	single manufacturer increase of at least 10 percent in the price 225
335	335
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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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345	345
346	346
347	347	of a drug, a manufacturer must provide notice of the upcoming 226
348	348	drug price increase to: 227
349	349	1. The department, the Department of Health, the agency, 228
350	350	the division, and the office. 229
351	351	2. Every health insurer that covers the drug. The 230
352	352	manufacturer shall use the contact list published by the office 231
353	353	under ss. 627.42384 and 641.3131 to provide notice to health 232
354	354	insurers. Notification shall be presumed to occur on the date 233
355	355	that the manufacturer attempts to communicate with the 234
356	356	applicable point of contact published by the office. 235
357	357	(b) The notices must include, at a minimum, the following 236
358	358	information: 237
359	359	1. The name and current price of the drug. 238
360	360	2. The date that the increase will become effective. 239
361	361	3. The dollar amount of the intended increase in the price 240
362	362	of the drug. 241
363	363	4. The percentage price increase. 242
364	364	5. A statement of whether the price increase is 243
365	365	necessitated by a change or improvement of the drug and, if so, 244
366	366	a description of the change or improvement. 245
367	367	6. A description of any other factors that contributed to 246
368	368	the price increase. 247
369	369	7. The documentation necessary to support the information 248
370	370	reported under subparagraphs 5. and 6. 249
371	371	(3)(a) By July 1 of each year, a manufacturer shall submit 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
383	383
384	384	a report to the department, the Department of Health, the 251
385	385	agency, the division, and the office on each drug for which the 252
386	386	price, during the previous calendar year: 253
387	387	1. Was $100 or more for a 30 -day supply or for a course of 254
388	388	treatment lasting less than 30 days; or 255
389	389	2. Increased by at least 10 percent over the previous 256
390	390	price in a single manuf acturer price. 257
391	391	(b) The report must include, at a minimum, the following 258
392	392	information: 259
393	393	1. The name and the price at the time of the report of 260
394	394	each drug specified in paragraph (a) and the cumulative 261
395	395	percentage price increase during the previous calendar y ear. 262
396	396	2. The length of time the drug has been on the market. 263
397	397	3. The factors that contributed to the price increase. 264
398	398	4. The name of any generic version of the drug available on 265
399	399	the market. 266
400	400	5. The research and development costs associated with the 267
401	401	drug that were paid using public funds. 268
402	402	6. The direct costs incurred by the manufacturer to 269
403	403	manufacture, market, and distribute the drug and to ensure 270
404	404	ongoing safety and effectiveness research associated with the 271
405	405	drug. 272
406	406	7. The total sales revenue for the dr ug during the 273
407	407	previous calendar year. 274
408	408	8. The manufacturer's profit attributable to the drug 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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419	419
420	420
421	421	during the previous calendar year. 276
422	422	9. The introductory price of the drug when it was approved 277
423	423	by the United States Food and Drug Administration and the 278
424	424	cumulative yearly increase, by calendar year, in the price of 279
425	425	the drug during the previous 5 years or during the number of 280
426	426	years the drug has been on the market, whichever is less. 281
427	427	10. The 10 highest prices paid for the drug during the 282
428	428	previous year in other cou ntries. 283
429	429	11. The documentation necessary to support the information 284
430	430	reported under this paragraph. 285
431	431	(4)(a) Before reviewing the data in the report filed under 286
432	432	subsection (3), the department, in consultation with the 287
433	433	Department of Health, the agency, and the office, shall compile 288
434	434	a list of drugs that have a significant cost to the state or 289
435	435	that are designated as being critical to public health. Such 290
436	436	drugs may be sourced from the Medicaid drug utilization data and 291
437	437	drug spending data, the division's drug spe nding data, and the 292
438	438	drug spending data of health insurers and health plans and their 293
439	439	pharmacy benefit managers. 294
440	440	(b) After receiving the report required under subsection 295
441	441	(3), the department: 296
442	442	1. May make a written request to the manufacturer for 297
443	443	supporting documentation or additional information concerning 298
444	444	the report. The department shall prescribe by rule the 299
445	445	timeframes for the department's request for documentation or 300
446	446
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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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456	456
457	457
458	458	information and for the manufacturer's response to the request. 301
459	459	The department may extend the timeframe, if necessary, for the 302
460	460	manufacturer's response. 303
461	461	2. Shall review the costs and the factors contributing to 304
462	462	each drug price or drug price increase in the report. 305
463	463	3. Shall review the price and price increase of each drug 306
464	464	on the list compiled under paragraph (a) and each drug on the 307
465	465	lists reported by wholesale distributors and other entities 308
466	466	engaged in wholesale distribution of prescription drugs and by 309
467	467	registered pharmacy bene fit managers under ss. 499.0121(16) and 310
468	468	624.490(6)(b), respectively, to make sure that any drug on the 311
469	469	compiled and reported lists which fits the criterion in 312
470	470	subparagraph (3)(a)1. or subparagraph (3)(a)2. is also reported 313
471	471	by the drug's manufacturer under subsection (3). 314
472	472	4. Shall, in consultation with the Department of Health, 315
473	473	the division, and the office, determine whether the manufacturer 316
474	474	has violated this section. 317
475	475	(5) A manufacturer violates this section if the 318
476	476	manufacturer: 319
477	477	(a) Fails to timely sub mit notices or reports required 320
478	478	under this section; 321
479	479	(b) Fails to provide information required under this 322
480	480	section; 323
481	481	(c) Fails to timely respond to a written request by the 324
482	482	department with regard to the notices or report required under 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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493	493
494	494
495	495	this section; or 326
496	496	(d) Provides inaccurate or incomplete information in the 327
497	497	notices or report required under this section. 328
498	498	(6) A drug for which the manufacturer does not comply with 329
499	499	the notification or reporting requirements under this section 330
500	500	may not be included in the Me dicaid's and state group health 331
501	501	insurance's drug formularies unless the drug is the most 332
502	502	clinically appropriate, clinically effective, and lowest net -333
503	503	cost drug. 334
504	504	(7)(a) The department may deny an application for a 335
505	505	renewal permit or suspend or revoke a per mit of a prescription 336
506	506	drug manufacturer or nonresident prescription drug manufacturer 337
507	507	for violating this section. 338
508	508	(b)1. The department may also impose an administrative 339
509	509	fine, not to exceed $5,000 per violation per day, for a 340
510	510	violation of this section or a rule adopted under this section. 341
511	511	Each day the violation continues constitutes a separate 342
512	512	violation, and each such separate violation is subject to a 343
513	513	separate fine. 344
514	514	2. In determining the amount of fine to be levied for a 345
515	515	violation of this section, the d epartment, in consultation with 346
516	516	the Department of Health, the agency, the division, and the 347
517	517	office, must consider the following factors: 348
518	518	a. The severity of the violation. 349
519	519	b. Any action taken by the permittee to correct the 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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530	530
531	531
532	532	violation or to remedy compla ints. 351
533	533	c. Any previous violation. 352
534	534	3. All fines collected under this section shall be 353
535	535	deposited into the Public Medical Assistance Trust Fund 354
536	536	administered by the agency, to be used to help the uninsured pay 355
537	537	for health care. 356
538	538	(8) The department shall ado pt rules to administer this 357
539	539	section. 358
540	540	Section 4. Paragraph (m) of subsection (1) of section 359
541	541	499.05, Florida Statutes, is amended, and paragraph (o) is added 360
542	542	to that subsection, to read: 361
543	543	499.05 Rules.— 362
544	544	(1) The department shall adopt rules to implemen t and 363
545	545	enforce this chapter with respect to: 364
546	546	(m) Wholesale distributor reporting requirements of s. 365
547	547	499.0121(14) and (16) s. 499.0121(14). 366
548	548	(o) Manufacturer notification and reporting requirements 367
549	549	of s. 499.026(2) and (3). 368
550	550	Section 5. Subsection (6) of section 624.490, Florida 369
551	551	Statutes, is renumbered as subsection (7), and a new subsection 370
552	552	(6) is added to that section, to read: 371
553	553	624.490 Registration of pharmacy benefit managers ; 372
554	554	prescription drug price report and public access requirements; 373
555	555	penalties for noncompliance.— 374
556	556	(6)(a) As used in this subsection, the term: 375
557	557
558	558	HB 1183 2022
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560	560
561	561
562	562	CODING: Words stricken are deletions; words underlined are additions.
563	563	hb1183-00
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565	565	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
566	566
567	567
568	568
569	569	1. "Negotiated price" means the value at which a 376
570	570	prescription drug is sold by a prescription drug manufacturer, 377
571	571	prescription drug wholesale distributor, or pharmacy, under a 378
572	572	prescription drug benefits coverage administered by a pharmacy 379
573	573	benefit manager, before any tax or cost is added and any 380
574	574	discount, rebate, or reduction in price, including a rebate 381
575	575	offered to the pharmacy benefit manager, is subtracted. 382
576	576	2. "Net price" means the value at which a prescription 383
577	577	drug is sold by a prescription drug manufacturer, prescription 384
578	578	drug wholesale distributor, or pharmacy, under a prescription 385
579	579	drug benefits coverage administered by a pharmacy benefit 386
580	580	manager, after all taxes and other costs are add ed and all 387
581	581	discounts, rebates, and reductions in price are subtracted, 388
582	582	including any rebate offered to the pharmacy benefit manager 389
583	583	which is passed on to the health insurer or health maintenance 390
584	584	organization. 391
585	585	3. "Rebate offered to a pharmacy benefit manager" means a 392
586	586	direct payment by a prescription drug manufacturer, prescription 393
587	587	drug wholesale distributor, or pharmacy to a pharmacy benefit 394
588	588	manager for a prescription drug dispensed to an insured or 395
589	589	subscriber. Such payment serves an incentive for the pharmacy 396
590	590	benefit manager to promote use of the prescription drug, and the 397
591	591	pharmacy benefit manager may choose to keep the payment or to 398
592	592	pass it on, in full or in part, to the health insurer or health 399
593	593	maintenance organization. 400
594	594
595	595	HB 1183 2022
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597	597
598	598
599	599	CODING: Words stricken are deletions; words underlined are additions.
600	600	hb1183-00
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602	602	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
603	603
604	604
605	605
606	606	(b)1. By July 1 of each year , a registered pharmacy 401
607	607	benefit manager shall submit a report to the office on each 402
608	608	prescription drug for which the negotiated price, during the 403
609	609	previous calendar year: 404
610	610	a. Was $100 or more for a 30 -day supply or for a course of 405
611	611	treatment lasting less tha n 30 days; or 406
612	612	b. Increased by at least 10 percent over the previous 407
613	613	negotiated price. 408
614	614	2. The report must include, at a minimum, the following 409
615	615	information: 410
616	616	a. The name and the negotiated price at the time of the 411
617	617	report of each prescription drug specif ied in subparagraph 1. 412
618	618	and the cumulative percentage negotiated price increase during 413
619	619	the previous calendar year. 414
620	620	b. The name of any generic version of the prescription drug 415
621	621	available on the market. 416
622	622	c. The total sales revenue of the pharmacy benefit man ager 417
623	623	for the prescription drug during the previous calendar year. 418
624	624	d. The documentation necessary to support the information 419
625	625	reported under this paragraph. 420
626	626	3. The office may make a written request to the pharmacy 421
627	627	benefit manager for supporting documenta tion or additional 422
628	628	information concerning the report. The commission shall 423
629	629	prescribe by rule the timeframes for the office's request for 424
630	630	documentation or information and for the pharmacy benefit 425
631	631
632	632	HB 1183 2022
633	633
634	634
635	635
636	636	CODING: Words stricken are deletions; words underlined are additions.
637	637	hb1183-00
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639	639	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
640	640
641	641
642	642
643	643	manager's response to the request. The office may extend the 426
644	644	timeframe, if necessary, for the pharmacy benefit manager's 427
645	645	response. 428
646	646	(c) A registered pharmacy benefit manager shall maintain a 429
647	647	website that provides public access to the net price of each 430
648	648	prescription drug. The registered pharmacy benefit manager shall 431
649	649	update the net price of a prescription drug on the website at 432
650	650	least 90 days before the net price of the prescription drug 433
651	651	changes. 434
652	652	(d) A registered pharmacy benefit manager violates this 435
653	653	subsection if the registered pharmacy benefit manager: 436
654	654	1. Fails to timely submit the report required under 437
655	655	paragraph (b); 438
656	656	2. Fails to provide information required under paragraph 439
657	657	(b); 440
658	658	3. Fails to timely respond to a written request by the 441
659	659	office with regard to the report required under paragraph (b); 442
660	660	4. Provides inaccurate or incomplete information in the 443
661	661	report required under paragraph (b); or 444
662	662	5. Fails to maintain a website for access to net prices of 445
663	663	prescription drugs or to update the net prices on the website, 446
664	664	as required under paragraph (c). 447
665	665	(e)1. The office may deny an application for renewal 448
666	666	registration or suspend or revoke a registration certificate of 449
667	667	a pharmacy benefit manager for violating this subsection. 450
668	668
669	669	HB 1183 2022
670	670
671	671
672	672
673	673	CODING: Words stricken are deletions; words underlined are additions.
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676	676	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
677	677
678	678
679	679
680	680	2.a. The office may also impose an administrative fine, 451
681	681	not to exceed $5,000 per violation p er day, for a violation of 452
682	682	this subsection or a rule adopted to administer this subsection. 453
683	683	Each day the violation continues constitutes a separate 454
684	684	violation, and each such separate violation is subject to a 455
685	685	separate fine. 456
686	686	b. In determining the amount of fine to be levied for a 457
687	687	violation of this subsection, the office must consider the 458
688	688	following factors: 459
689	689	(I) The severity of the violation. 460
690	690	(II) Any action taken by the pharmacy benefit manager to 461
691	691	correct the violation or to remedy complaints. 462
692	692	(III) Any previous violation. 463
693	693	c. All fines collected under this subsection shall be 464
694	694	deposited into the Public Medical Assistance Trust Fund 465
695	695	administered by the Agency for Health Care Administration, to be 466
696	696	used to help the uninsured pay for health care. 467
697	697	Section 6. Section 627.42384, Florida Statutes, is created 468
698	698	to read: 469
699	699	627.42384 Formulary changes resulting from drug price 470
700	700	increases.— 471
701	701	(1) A health insurer issuing a major medical individual or 472
702	702	group policy shall submit, and update as necessary, contact 473
703	703	information for a single point of contact for use by 474
704	704	prescription drug manufacturers to comply with s. 499.026. The 475
705	705
706	706	HB 1183 2022
707	707
708	708
709	709
710	710	CODING: Words stricken are deletions; words underlined are additions.
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713	713	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
714	714
715	715
716	716
717	717	office shall maintain and publish on its website a list of such 476
718	718	points of contact. 477
719	719	(2) A health insurer issuing a major medical individual or 478
720	720	group policy must provide written notice to each affected 479
721	721	insured and each prescribing health care provider at least 90 480
722	722	days before making a drug formulary change that results from a 481
723	723	prescription drug price increase reported by a drug manufacturer 482
724	724	under s. 499.026(2). 483
725	725	(3) This section applies to policies entered into or 484
726	726	renewed on or after January 1, 2023. 485
727	727	Section 7. Paragraph (b) of subsection (1) of section 486
728	728	627.64741, Florida Statutes, is redesignated as paragraph (c), 487
729	729	subsection (5) is amended, a new paragraph (b) is added to 488
730	730	subsection (1), and paragraphs (c) through (f) are added to 489
731	731	subsection (2) of that section, to read: 490
732	732	627.64741 Pharmacy benefit manager contracts. — 491
733	733	(1) As used in this section, the term: 492
734	734	(b) "Net price" means the value a t which a prescription 493
735	735	drug is sold by a prescription drug manufacturer, prescription 494
736	736	drug wholesale distributor, or pharmacy, under a prescription 495
737	737	drug benefits coverage administered by a pharmacy benefit 496
738	738	manager, after all taxes and other costs are added and all 497
739	739	discounts, rebates, and reductions in price are subtracted, 498
740	740	including any rebate offered to the pharmacy benefit manager 499
741	741	which is passed on to the health insurer. 500
742	742
743	743	HB 1183 2022
744	744
745	745
746	746
747	747	CODING: Words stricken are deletions; words underlined are additions.
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750	750	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
751	751
752	752
753	753
754	754	(2) A contract between a health insurer and a pharmacy 501
755	755	benefit manager must requir e that the pharmacy benefit manager: 502
756	756	(c) Maintain a website that provides public access to the 503
757	757	net price of each covered prescription drug and update the net 504
758	758	price of a covered prescription drug on the website at least 90 505
759	759	days before the net price of the covered prescription drug 506
760	760	changes. 507
761	761	(d) Provide written notice to each affected insured and 508
762	762	each prescribing health care provider at least 90 days before 509
763	763	making a change in the drug formulary or in the net price of a 510
764	764	covered prescription drug, including a change that results from 511
765	765	a price increase of a covered prescription drug reported by a 512
766	766	drug manufacturer under s. 499.026(2). 513
767	767	(e) Inform an affected insured, in writing, of the net 514
768	768	price of each covered prescription drug for which the insured 515
769	769	has made a payment. 516
770	770	(f) Provide in writing to each insured and each 517
771	771	prescribing health care provider the address of the pharmacy 518
772	772	benefit manager's website where the list of the net prices of 519
773	773	all prescription drugs is posted. 520
774	774	(5) This section applies to contract s entered into or 521
775	775	renewed on or after July 1, 2022 July 1, 2018. 522
776	776	Section 8. Paragraph (b) of subsection (1) of section 523
777	777	627.6572, Florida Statutes, is redesignated as paragraph (c), 524
778	778	subsection (5) is amended, a new paragraph (b) is added to 525
779	779
780	780	HB 1183 2022
781	781
782	782
783	783
784	784	CODING: Words stricken are deletions; words underlined are additions.
785	785	hb1183-00
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787	787	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
788	788
789	789
790	790
791	791	subsection (1), and paragraphs (c) through (f) are added to 526
792	792	subsection (2) of that section, to read: 527
793	793	627.6572 Pharmacy benefit manager contracts. — 528
794	794	(1) As used in this section, the term: 529
795	795	(b) "Net price" means the value at which a prescription 530
796	796	drug is sold by a prescription drug manufacturer, prescription 531
797	797	drug wholesale distributor, or pharmacy, under a prescription 532
798	798	drug benefits coverage administered by a pharmacy benefit 533
799	799	manager, after all taxes and other costs are added and all 534
800	800	discounts, rebates, and reductio ns in price are subtracted, 535
801	801	including any rebate offered to the pharmacy benefit manager 536
802	802	which is passed on to the health insurer. 537
803	803	(2) A contract between a health insurer and a pharmacy 538
804	804	benefit manager must require that the pharmacy benefit manager: 539
805	805	(c) Maintain a website that provides public access to the 540
806	806	net price of each covered prescription drug and update the net 541
807	807	price of a covered prescription drug on the website at least 90 542
808	808	days before the net price of the covered prescription drug 543
809	809	changes. 544
810	810	(d) Provide written notice to each affected insured and 545
811	811	each prescribing health care provider at least 90 days before 546
812	812	making a change in the drug formulary or in the net price of a 547
813	813	covered prescription drug, including a change that results from 548
814	814	a price increase of a covered prescription drug reported by a 549
815	815	drug manufacturer under s. 499.026(2). 550
816	816
817	817	HB 1183 2022
818	818
819	819
820	820
821	821	CODING: Words stricken are deletions; words underlined are additions.
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824	824	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
825	825
826	826
827	827
828	828	(e) Inform an insured, in writing, of the net price of 551
829	829	each covered prescription drug for which the insured has made a 552
830	830	payment. 553
831	831	(f) Provide in writing to each insure d and each 554
832	832	prescribing health care provider the address of the pharmacy 555
833	833	benefit manager's website where the list of the net prices of 556
834	834	all covered prescription drugs is posted. 557
835	835	(5) This section applies to contracts entered into or 558
836	836	renewed on or after July 1, 2022 July 1, 2018. 559
837	837	Section 9. Section 641.3131, Florida Statutes, is created 560
838	838	to read: 561
839	839	641.3131 Formulary changes resulting from drug price 562
840	840	increases.— 563
841	841	(1) A health maintenance organization issuing a major 564
842	842	medical or other comprehensive coverage contract shall submit, 565
843	843	and update as necessary, contact information for a single point 566
844	844	of contact for use by prescription drug manufacturers to comply 567
845	845	with s. 499.026. The office shall maintain and publish on its 568
846	846	website a list of such points of contact. 569
847	847	(2) A health maintenance organization issuing a major 570
848	848	medical or other comprehensive coverage contract must provide 571
849	849	written notice to each affected subscriber and each prescribing 572
850	850	health care provider at least 90 days before making a drug 573
851	851	formulary change that results from a prescription drug price 574
852	852	increase reported by a drug manufacturer under s. 499.026(2). 575
853	853
854	854	HB 1183 2022
855	855
856	856
857	857
858	858	CODING: Words stricken are deletions; words underlined are additions.
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861	861	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
862	862
863	863
864	864
865	865	(3) This section applies to contracts entered into or 576
866	866	renewed on or after January 1, 2023. 577
867	867	Section 10. Paragraph (b) of subsection (1) of 641. 314, 578
868	868	Florida Statutes, is redesignated as paragraph (c), subsection 579
869	869	(5) is amended, a new paragraph (b) is added to subsection (1), 580
870	870	and paragraphs (c) through (f) are added to subsection (2) of 581
871	871	that section, to read: 582
872	872	641.314 Pharmacy benefit manager cont racts.— 583
873	873	(1) As used in this section, the term: 584
874	874	(b) "Net price" means the value at which a prescription 585
875	875	drug is sold by a prescription drug manufacturer, prescription 586
876	876	drug wholesale distributor, or pharmacy, under a prescription 587
877	877	drug benefits coverage a dministered by a pharmacy benefit 588
878	878	manager, after all taxes and other costs are added and all 589
879	879	discounts, rebates, and reductions in price are subtracted, 590
880	880	including any rebate offered to the pharmacy benefit manager 591
881	881	which is passed on to the health maintenan ce organization. 592
882	882	(2) A contract between a health maintenance organization 593
883	883	and a pharmacy benefit manager must require that the pharmacy 594
884	884	benefit manager: 595
885	885	(c) Maintain a website that provides public access to the 596
886	886	net price of each covered prescription drug and update the net 597
887	887	price of a covered prescription drug on the website at least 90 598
888	888	days before the net price of the covered prescription drug 599
889	889	changes. 600
890	890
891	891	HB 1183 2022
892	892
893	893
894	894
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896	896	hb1183-00
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898	898	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
899	899
900	900
901	901
902	902	(d) Provide written notice to each affected subscriber and 601
903	903	each prescribing health care provider a t least 90 days before 602
904	904	making a change in the drug formulary or in the net price of a 603
905	905	covered prescription drug, including a change that results from 604
906	906	a price increase of a covered prescription drug reported by a 605
907	907	drug manufacturer under s. 499.026(2). 606
908	908	(e) Inform a subscriber in writing of the net price of 607
909	909	each covered prescription drug for which the subscriber has made 608
910	910	a payment. 609
911	911	(f) Provide in writing to each subscriber and each 610
912	912	prescribing health care provider the address of the pharmacy 611
913	913	benefit manager's website where the list of the net prices of 612
914	914	all prescription drugs is posted. 613
915	915	(5) This section applies to contracts entered into or 614
916	916	renewed on or after July 1, 2022 July 1, 2018. 615
917	917	Section 11. Subsections (3) and (4) and paragraph (a) of 616
918	918	subsection (9) of section 110.12315, Florida Statutes, are 617
919	919	amended to read: 618
920	920	110.12315 Prescription drug program. —The state employees' 619
921	921	prescription drug program is established. This program shall be 620
922	922	administered by the Department of Management Services, according 621
923	923	to the terms and conditions of the plan as established by the 622
924	924	relevant provisions of the annual General Appropriations Act and 623
925	925	implementing legislation, subject to the following conditions: 624
926	926	(3) The department shall maintain the generic, preferred 625
927	927
928	928	HB 1183 2022
929	929
930	930
931	931
932	932	CODING: Words stricken are deletions; words underlined are additions.
933	933	hb1183-00
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935	935	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
936	936
937	937
938	938
939	939	brand name, and the nonpreferred brand name lists of drugs and 626
940	940	supplies to be used in the administration of the state 627
941	941	employees' prescription drug program. These lists may not 628
942	942	include a prescription drug for which the prescription drug 629
943	943	manufacturer does not comply with the requirements of s. 499.026 630
944	944	unless the prescription drug is the most clinically appropriate, 631
945	945	clinically effective, and lowest net -cost prescription drug. 632
946	946	(4) The department shall maintain a list of maintenance 633
947	947	drugs and supplies. The list may not include a drug for which 634
948	948	the prescription drug manufacturer does not comply with the 635
949	949	requirements of s. 499.026 unless the prescription drug is the 636
950	950	most clinically appropriate, clinically effective, and lowest 637
951	951	net-cost prescription drug. 638
952	952	(a) Preferred provider organization health plan members 639
953	953	may have prescriptions for maintenance drugs and supplies filled 640
954	954	up to three times as a supply for up to 30 days through a retail 641
955	955	pharmacy; thereafter, prescriptions for the same maintenance 642
956	956	drug or supply must be filled for up to 90 days either through 643
957	957	the department's contracted mail order pharmacy or through a 644
958	958	retail pharmacy. 645
959	959	(b) Health maintenance organization health plan members 646
960	960	may have prescriptions for maintenance drugs and supplies filled 647
961	961	for up to 90 days either through a mail order pharmacy or 648
962	962	through a retail pharmacy. 649
963	963	(9)(a) Beginning with the 2020 plan year, the department 650
964	964
965	965	HB 1183 2022
966	966
967	967
968	968
969	969	CODING: Words stricken are deletions; words underlined are additions.
970	970	hb1183-00
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972	972	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
973	973
974	974
975	975
976	976	must implement formulary management for prescription drugs and 651
977	977	supplies. Such management practices must require prescription 652
978	978	drugs to be subject to formulary inclusion or exclusion and, 653
979	979	beginning with the 2023 plan year, must require a prescription 654
980	980	drug for which the prescription drug manufacturer does not 655
981	981	comply with the requirements of s. 499.026 to be subject to 656
982	982	formulary exclusion, but may not restrict access to the most 657
983	983	clinically appropriate, clinically effective, and lowest net -658
984	984	cost prescription drugs and supplies. Drugs excluded from the 659
985	985	formulary must be available for inclusion if a physician, 660
986	986	advanced practice registered nurse, or physician assistant 661
987	987	prescribing a pharmaceutical clearly states on the prescription 662
988	988	that the excluded drug is medically necessary. Prescription 663
989	989	drugs and supplies first made available in the marketplace after 664
990	990	January 1, 2020, may not be covered b y the prescription drug 665
991	991	program until specifically included in the list of covered 666
992	992	prescription drugs and supplies. 667
993	993	Section 12. Paragraph (n) of subsection (2) of section 668
994	994	409.815, Florida Statutes, is amended to read: 669
995	995	409.815 Health benefits coverage ; limitations.— 670
996	996	(2) BENCHMARK BENEFITS. —In order for health benefits 671
997	997	coverage to qualify for premium assistance payments for an 672
998	998	eligible child under ss. 409.810 -409.821, the health benefits 673
999	999	coverage, except for coverage under Medicaid and Medikids, must 674
1000	1000	include the following minimum benefits, as medically necessary. 675
1001	1001
1002	1002	HB 1183 2022
1003	1003
1004	1004
1005	1005
1006	1006	CODING: Words stricken are deletions; words underlined are additions.
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1009	1009	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
1010	1010
1011	1011
1012	1012
1013	1013	(n) Prescribed drugs. — 676
1014	1014	1. Coverage shall include drugs prescribed for the 677
1015	1015	treatment of illness or injury when prescribed by a licensed 678
1016	1016	health practitioner acting within the scope of his or her 679
1017	1017	practice. 680
1018	1018	2. Prescribed drugs may be limited to generics if 681
1019	1019	available and brand name products if a generic substitution is 682
1020	1020	not available, unless the prescribing licensed health 683
1021	1021	practitioner indicates that a brand name is medically necessary. 684
1022	1022	3. Prescribed drugs covered under this section shall 685
1023	1023	include all prescribed drugs covered under the Florida Medicaid 686
1024	1024	program. 687
1025	1025	4. Prescribed drugs may not include a prescription drug 688
1026	1026	for which the manufacturer does not comply with the requirements 689
1027	1027	of s. 499.026 unless the prescription drug is the most 690
1028	1028	clinically appropriate, clinically effective, and lowest net -691
1029	1029	cost prescription drug or unless a physician, advanced practice 692
1030	1030	registered nurse, or physician assistant prescribing the drug 693
1031	1031	clearly states on the pres cription that the excluded drug is 694
1032	1032	medically necessary. 695
1033	1033	Section 13. Subsection (8) of section 409.91195, Florida 696
1034	1034	Statutes, is amended to read: 697
1035	1035	409.91195 Medicaid Pharmaceutical and Therapeutics 698
1036	1036	Committee.—There is created a Medicaid Pharmaceutical an d 699
1037	1037	Therapeutics Committee within the agency for the purpose of 700
1038	1038
1039	1039	HB 1183 2022
1040	1040
1041	1041
1042	1042
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1046	1046	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
1047	1047
1048	1048
1049	1049
1050	1050	developing a Medicaid preferred drug list. 701
1051	1051	(8) The committee shall develop its preferred drug list 702
1052	1052	recommendations by considering the clinical efficacy, safety, 703
1053	1053	and cost-effectiveness of a pro duct and the manufacturer's 704
1054	1054	prescription drug price transparency, as required under s. 705
1055	1055	499.012. 706
1056	1056	Section 14. Paragraph (a) of subsection (5) of section 707
1057	1057	409.912, Florida Statutes, is amended to read: 708
1058	1058	409.912 Cost-effective purchasing of health care. —The 709
1059	1059	agency shall purchase goods and services for Medicaid recipients 710
1060	1060	in the most cost-effective manner consistent with the delivery 711
1061	1061	of quality medical care. To ensure that medical services are 712
1062	1062	effectively utilized, the agency may, in any case, require a 713
1063	1063	confirmation or second physician's opinion of the correct 714
1064	1064	diagnosis for purposes of authorizing future services under the 715
1065	1065	Medicaid program. This section does not restrict access to 716
1066	1066	emergency services or poststabilization care services as defined 717
1067	1067	in 42 C.F.R. s. 438.114. Such confirmation or second opinion 718
1068	1068	shall be rendered in a manner approved by the agency. The agency 719
1069	1069	shall maximize the use of prepaid per capita and prepaid 720
1070	1070	aggregate fixed-sum basis services when appropriate and other 721
1071	1071	alternative service deliv ery and reimbursement methodologies, 722
1072	1072	including competitive bidding pursuant to s. 287.057, designed 723
1073	1073	to facilitate the cost -effective purchase of a case -managed 724
1074	1074	continuum of care. The agency shall also require providers to 725
1075	1075
1076	1076	HB 1183 2022
1077	1077
1078	1078
1079	1079
1080	1080	CODING: Words stricken are deletions; words underlined are additions.
1081	1081	hb1183-00
1082	1082	Page 30 of 43
1083	1083	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
1084	1084
1085	1085
1086	1086
1087	1087	minimize the exposure of recipient s to the need for acute 726
1088	1088	inpatient, custodial, and other institutional care and the 727
1089	1089	inappropriate or unnecessary use of high -cost services. The 728
1090	1090	agency shall contract with a vendor to monitor and evaluate the 729
1091	1091	clinical practice patterns of providers in order to identify 730
1092	1092	trends that are outside the normal practice patterns of a 731
1093	1093	provider's professional peers or the national guidelines of a 732
1094	1094	provider's professional association. The vendor must be able to 733
1095	1095	provide information and counseling to a provider whose pract ice 734
1096	1096	patterns are outside the norms, in consultation with the agency, 735
1097	1097	to improve patient care and reduce inappropriate utilization. 736
1098	1098	The agency may mandate prior authorization, drug therapy 737
1099	1099	management, or disease management participation for certain 738
1100	1100	populations of Medicaid beneficiaries, certain drug classes, or 739
1101	1101	particular drugs to prevent fraud, abuse, overuse, and possible 740
1102	1102	dangerous drug interactions. The Pharmaceutical and Therapeutics 741
1103	1103	Committee shall make recommendations to the agency on drugs for 742
1104	1104	which prior authorization is required. The agency shall inform 743
1105	1105	the Pharmaceutical and Therapeutics Committee of its decisions 744
1106	1106	regarding drugs subject to prior authorization. The agency is 745
1107	1107	authorized to limit the entities it contracts with or enrolls as 746
1108	1108	Medicaid providers by developing a provider network through 747
1109	1109	provider credentialing. The agency may competitively bid single -748
1110	1110	source-provider contracts if procurement of goods or services 749
1111	1111	results in demonstrated cost savings to the state without 750
1112	1112
1113	1113	HB 1183 2022
1114	1114
1115	1115
1116	1116
1117	1117	CODING: Words stricken are deletions; words underlined are additions.
1118	1118	hb1183-00
1119	1119	Page 31 of 43
1120	1120	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
1121	1121
1122	1122
1123	1123
1124	1124	limiting access to car e. The agency may limit its network based 751
1125	1125	on the assessment of beneficiary access to care, provider 752
1126	1126	availability, provider quality standards, time and distance 753
1127	1127	standards for access to care, the cultural competence of the 754
1128	1128	provider network, demographic chara cteristics of Medicaid 755
1129	1129	beneficiaries, practice and provider -to-beneficiary standards, 756
1130	1130	appointment wait times, beneficiary use of services, provider 757
1131	1131	turnover, provider profiling, provider licensure history, 758
1132	1132	previous program integrity investigations and find ings, peer 759
1133	1133	review, provider Medicaid policy and billing compliance records, 760
1134	1134	clinical and medical record audits, and other factors. Providers 761
1135	1135	are not entitled to enrollment in the Medicaid provider network. 762
1136	1136	The agency shall determine instances in which allo wing Medicaid 763
1137	1137	beneficiaries to purchase durable medical equipment and other 764
1138	1138	goods is less expensive to the Medicaid program than long -term 765
1139	1139	rental of the equipment or goods. The agency may establish rules 766
1140	1140	to facilitate purchases in lieu of long -term rentals in order to 767
1141	1141	protect against fraud and abuse in the Medicaid program as 768
1142	1142	defined in s. 409.913. The agency may seek federal waivers 769
1143	1143	necessary to administer these policies. 770
1144	1144	(5)(a) The agency shall implement a Medicaid prescribed -771
1145	1145	drug spending-control program that includes the following 772
1146	1146	components: 773
1147	1147	1. A Medicaid preferred drug list, which shall be a 774
1148	1148	listing of cost-effective therapeutic options recommended by the 775
1149	1149
1150	1150	HB 1183 2022
1151	1151
1152	1152
1153	1153
1154	1154	CODING: Words stricken are deletions; words underlined are additions.
1155	1155	hb1183-00
1156	1156	Page 32 of 43
1157	1157	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
1158	1158
1159	1159
1160	1160
1161	1161	Medicaid Pharmacy and Therapeutics Committee established 776
1162	1162	pursuant to s. 409.91195 and adopted by the agency for each 777
1163	1163	therapeutic class on the preferred drug list. At the discretion 778
1164	1164	of the committee, and when feasible, the preferred drug list 779
1165	1165	should include at least two products in a therapeutic class. The 780
1166	1166	agency may post the preferred drug list and updates to the list 781
1167	1167	on an Internet website without following the rulemaking 782
1168	1168	procedures of chapter 120. Drugs for which the manufacturer does 783
1169	1169	not comply with the requirements of s. 499.026 are excluded from 784
1170	1170	the preferred list, unless the drug is the most c linically 785
1171	1171	appropriate, clinically effective, and lowest net -cost 786
1172	1172	prescription drug. Antiretroviral agents are excluded from the 787
1173	1173	preferred drug list. The agency shall also limit the amount of a 788
1174	1174	prescribed drug dispensed to no more than a 34 -day supply unless 789
1175	1175	the drug products' smallest marketed package is greater than a 790
1176	1176	34-day supply, or the drug is determined by the agency to be a 791
1177	1177	maintenance drug in which case a 100 -day maximum supply may be 792
1178	1178	authorized. The agency may seek any federal waivers necessary to 793
1179	1179	implement these cost -control programs and to continue 794
1180	1180	participation in the federal Medicaid rebate program, or 795
1181	1181	alternatively to negotiate state -only manufacturer rebates. The 796
1182	1182	agency may adopt rules to administer this subparagraph. The 797
1183	1183	agency shall continue to provide unlimited contraceptive drugs 798
1184	1184	and items. The agency must establish procedures to ensure that: 799
1185	1185	a. There is a response to a request for prior 800
1186	1186
1187	1187	HB 1183 2022
1188	1188
1189	1189
1190	1190
1191	1191	CODING: Words stricken are deletions; words underlined are additions.
1192	1192	hb1183-00
1193	1193	Page 33 of 43
1194	1194	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
1195	1195
1196	1196
1197	1197
1198	1198	authorization by telephone or other telecommunication device 801
1199	1199	within 24 hours after receipt of a reques t for prior 802
1200	1200	authorization; and 803
1201	1201	b. A 72-hour supply of the drug prescribed is provided in 804
1202	1202	an emergency or when the agency does not provide a response 805
1203	1203	within 24 hours as required by sub -subparagraph a. 806
1204	1204	2. A provider of prescribed drugs is reimbursed in an 807
1205	1205	amount not to exceed the lesser of the actual acquisition cost 808
1206	1206	based on the Centers for Medicare and Medicaid Services National 809
1207	1207	Average Drug Acquisition Cost pricing files plus a professional 810
1208	1208	dispensing fee, the wholesale acquisition cost plus a 811
1209	1209	professional dispensing fee, the state maximum allowable cost 812
1210	1210	plus a professional dispensing fee, or the usual and customary 813
1211	1211	charge billed by the provider. 814
1212	1212	3. The agency shall develop and implement a process for 815
1213	1213	managing the drug therapies of Medicaid recipient s who are using 816
1214	1214	significant numbers of prescribed drugs each month. The 817
1215	1215	management process may include, but is not limited to, 818
1216	1216	comprehensive, physician -directed medical-record reviews, claims 819
1217	1217	analyses, and case evaluations to determine the medical 820
1218	1218	necessity and appropriateness of a patient's treatment plan and 821
1219	1219	drug therapies. The agency may contract with a private 822
1220	1220	organization to provide drug -program-management services. The 823
1221	1221	Medicaid drug benefit management program shall include 824
1222	1222	initiatives to manage drug t herapies for HIV/AIDS patients, 825
1223	1223
1224	1224	HB 1183 2022
1225	1225
1226	1226
1227	1227
1228	1228	CODING: Words stricken are deletions; words underlined are additions.
1229	1229	hb1183-00
1230	1230	Page 34 of 43
1231	1231	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
1232	1232
1233	1233
1234	1234
1235	1235	patients using 20 or more unique prescriptions in a 180 -day 826
1236	1236	period, and the top 1,000 patients in annual spending. The 827
1237	1237	agency shall enroll any Medicaid recipient in the drug benefit 828
1238	1238	management program if he or she meets the specifications of this 829
1239	1239	provision and is not enrolled in a Medicaid health maintenance 830
1240	1240	organization. 831
1241	1241	4. The agency may limit the size of its pharmacy network 832
1242	1242	based on need, competitive bidding, price negotiations, 833
1243	1243	credentialing, or similar criteria. The a gency shall give 834
1244	1244	special consideration to rural areas in determining the size and 835
1245	1245	location of pharmacies included in the Medicaid pharmacy 836
1246	1246	network. A pharmacy credentialing process may include criteria 837
1247	1247	such as a pharmacy's full -service status, location, si ze, 838
1248	1248	patient educational programs, patient consultation, disease 839
1249	1249	management services, and other characteristics. The agency may 840
1250	1250	impose a moratorium on Medicaid pharmacy enrollment if it is 841
1251	1251	determined that it has a sufficient number of Medicaid -842
1252	1252	participating providers. The agency must allow dispensing 843
1253	1253	practitioners to participate as a part of the Medicaid pharmacy 844
1254	1254	network regardless of the practitioner's proximity to any other 845
1255	1255	entity that is dispensing prescription drugs under the Medicaid 846
1256	1256	program. A dispensing practitioner must meet all credentialing 847
1257	1257	requirements applicable to his or her practice, as determined by 848
1258	1258	the agency. 849
1259	1259	5. The agency shall develop and implement a program that 850
1260	1260
1261	1261	HB 1183 2022
1262	1262
1263	1263
1264	1264
1265	1265	CODING: Words stricken are deletions; words underlined are additions.
1266	1266	hb1183-00
1267	1267	Page 35 of 43
1268	1268	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
1269	1269
1270	1270
1271	1271
1272	1272	requires Medicaid practitioners who issue written prescriptions 851
1273	1273	for medicinal drugs to use a counterfeit -proof prescription pad 852
1274	1274	for Medicaid prescriptions. The agency shall require the use of 853
1275	1275	standardized counterfeit -proof prescription pads by prescribers 854
1276	1276	who issue written prescriptions for Medicaid recipients. The 855
1277	1277	agency may implement the program in targeted geographic areas or 856
1278	1278	statewide. 857
1279	1279	6. The agency may enter into arrangements that require 858
1280	1280	manufacturers of generic drugs prescribed to Medicaid recipients 859
1281	1281	to provide rebates of at least 15.1 percent of the average 860
1282	1282	manufacturer price for the manufacturer's generic products. 861
1283	1283	These arrangements shall require that if a generic -drug 862
1284	1284	manufacturer pays federal rebates for Medicaid -reimbursed drugs 863
1285	1285	at a level below 15.1 percent, the manufacturer must provide a 864
1286	1286	supplemental rebate to the state in an amount necessary to 865
1287	1287	achieve a 15.1-percent rebate level. 866
1288	1288	7. The agency may establish a preferred drug list as 867
1289	1289	described in this subsection, and, pursuant to the establishment 868
1290	1290	of such preferred drug list, negotiate supplemental rebates from 869
1291	1291	manufacturers that are in addition to those required by Title 870
1292	1292	XIX of the Social Security Act and at no less than 14 percent of 871
1293	1293	the average manufacturer price as defined in 42 U.S.C. s. 1936 872
1294	1294	on the last day of a quarter unless the federal or supplemental 873
1295	1295	rebate, or both, equals or exceeds 29 percent. There is no upper 874
1296	1296	limit on the supplemental rebates the agency may negotiate. The 875
1297	1297
1298	1298	HB 1183 2022
1299	1299
1300	1300
1301	1301
1302	1302	CODING: Words stricken are deletions; words underlined are additions.
1303	1303	hb1183-00
1304	1304	Page 36 of 43
1305	1305	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
1306	1306
1307	1307
1308	1308
1309	1309	agency may determine that specific products, brand -name or 876
1310	1310	generic, are competitive at lower rebate percentages. Agreement 877
1311	1311	to pay the minimum supplemental rebate percentage guarantees a 878
1312	1312	manufacturer that the Medicaid Pharmaceutical and Therapeutics 879
1313	1313	Committee will consider a product for inclusion on the preferred 880
1314	1314	drug list. However, a pharmaceutical manufacturer is not 881
1315	1315	guaranteed placement on the preferred drug list by simply paying 882
1316	1316	the minimum supplemental rebate. Agency decisions will be made 883
1317	1317	on the clinical efficacy of a drug and recommendations of the 884
1318	1318	Medicaid Pharmaceutical and Therapeutics Committee, as well as 885
1319	1319	the price of competing products minus federal and state rebates. 886
1320	1320	The agency may contract with an outside agency or contractor to 887
1321	1321	conduct negotiations for supplemental rebates. For the purposes 888
1322	1322	of this section, the term "supplemental rebates" means cash 889
1323	1323	rebates. Value-added programs as a substitution for supplemental 890
1324	1324	rebates are prohibited. The agency may seek any federal waivers 891
1325	1325	to implement this initiative. 892
1326	1326	8.a. The agency may implement a Medicaid behavioral drug 893
1327	1327	management system. The agency may contract with a vendor tha t 894
1328	1328	has experience in operating behavioral drug management systems 895
1329	1329	to implement this program. The agency may seek federal waivers 896
1330	1330	to implement this program. 897
1331	1331	b. The agency, in conjunction with the Department of 898
1332	1332	Children and Families, may implement the Medic aid behavioral 899
1333	1333	drug management system that is designed to improve the quality 900
1334	1334
1335	1335	HB 1183 2022
1336	1336
1337	1337
1338	1338
1339	1339	CODING: Words stricken are deletions; words underlined are additions.
1340	1340	hb1183-00
1341	1341	Page 37 of 43
1342	1342	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
1343	1343
1344	1344
1345	1345
1346	1346	of care and behavioral health prescribing practices based on 901
1347	1347	best practice guidelines, improve patient adherence to 902
1348	1348	medication plans, reduce clinical risk, and lower prescribed 903
1349	1349	drug costs and the rate of inappropriate spending on Medicaid 904
1350	1350	behavioral drugs. The program may include the following 905
1351	1351	elements: 906
1352	1352	(I) Provide for the development and adoption of best 907
1353	1353	practice guidelines for behavioral health -related drugs such as 908
1354	1354	antipsychotics, antidepressants, and medications for treating 909
1355	1355	bipolar disorders and other behavioral conditions; translate 910
1356	1356	them into practice; review behavioral health prescribers and 911
1357	1357	compare their prescribing patterns to a number of indicators 912
1358	1358	that are based on nat ional standards; and determine deviations 913
1359	1359	from best practice guidelines. 914
1360	1360	(II) Implement processes for providing feedback to and 915
1361	1361	educating prescribers using best practice educational materials 916
1362	1362	and peer-to-peer consultation. 917
1363	1363	(III) Assess Medicaid benefic iaries who are outliers in 918
1364	1364	their use of behavioral health drugs with regard to the numbers 919
1365	1365	and types of drugs taken, drug dosages, combination drug 920
1366	1366	therapies, and other indicators of improper use of behavioral 921
1367	1367	health drugs. 922
1368	1368	(IV) Alert prescribers to pati ents who fail to refill 923
1369	1369	prescriptions in a timely fashion, are prescribed multiple same -924
1370	1370	class behavioral health drugs, and may have other potential 925
1371	1371
1372	1372	HB 1183 2022
1373	1373
1374	1374
1375	1375
1376	1376	CODING: Words stricken are deletions; words underlined are additions.
1377	1377	hb1183-00
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1379	1379	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
1380	1380
1381	1381
1382	1382
1383	1383	medication problems. 926
1384	1384	(V) Track spending trends for behavioral health drugs and 927
1385	1385	deviation from best practic e guidelines. 928
1386	1386	(VI) Use educational and technological approaches to 929
1387	1387	promote best practices, educate consumers, and train prescribers 930
1388	1388	in the use of practice guidelines. 931
1389	1389	(VII) Disseminate electronic and published materials. 932
1390	1390	(VIII) Hold statewide and reg ional conferences. 933
1391	1391	(IX) Implement a disease management program with a model 934
1392	1392	quality-based medication component for severely mentally ill 935
1393	1393	individuals and emotionally disturbed children who are high 936
1394	1394	users of care. 937
1395	1395	9. The agency shall implement a Medicaid prescription drug 938
1396	1396	management system. 939
1397	1397	a. The agency may contract with a vendor that has 940
1398	1398	experience in operating prescription drug management systems in 941
1399	1399	order to implement this system. Any management system that is 942
1400	1400	implemented in accordance with this subp aragraph must rely on 943
1401	1401	cooperation between physicians and pharmacists to determine 944
1402	1402	appropriate practice patterns and clinical guidelines to improve 945
1403	1403	the prescribing, dispensing, and use of drugs in the Medicaid 946
1404	1404	program. The agency may seek federal waivers to implement this 947
1405	1405	program. 948
1406	1406	b. The drug management system must be designed to improve 949
1407	1407	the quality of care and prescribing practices based on best 950
1408	1408
1409	1409	HB 1183 2022
1410	1410
1411	1411
1412	1412
1413	1413	CODING: Words stricken are deletions; words underlined are additions.
1414	1414	hb1183-00
1415	1415	Page 39 of 43
1416	1416	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
1417	1417
1418	1418
1419	1419
1420	1420	practice guidelines, improve patient adherence to medication 951
1421	1421	plans, reduce clinical risk, and lower prescribed drug costs and 952
1422	1422	the rate of inappropriate spending on Medicaid prescription 953
1423	1423	drugs. The program must: 954
1424	1424	(I) Provide for the adoption of best practice guidelines 955
1425	1425	for the prescribing and use of drugs in the Medicaid program, 956
1426	1426	including translating best practice guidelines into practice; 957
1427	1427	reviewing prescriber patterns and comparing them to indicators 958
1428	1428	that are based on national standards and practice patterns of 959
1429	1429	clinical peers in their community, statewide, and nationally; 960
1430	1430	and determine deviations from best practic e guidelines. 961
1431	1431	(II) Implement processes for providing feedback to and 962
1432	1432	educating prescribers using best practice educational materials 963
1433	1433	and peer-to-peer consultation. 964
1434	1434	(III) Assess Medicaid recipients who are outliers in their 965
1435	1435	use of a single or multiple p rescription drugs with regard to 966
1436	1436	the numbers and types of drugs taken, drug dosages, combination 967
1437	1437	drug therapies, and other indicators of improper use of 968
1438	1438	prescription drugs. 969
1439	1439	(IV) Alert prescribers to recipients who fail to refill 970
1440	1440	prescriptions in a timely fashion, are prescribed multiple drugs 971
1441	1441	that may be redundant or contraindicated, or may have other 972
1442	1442	potential medication problems. 973
1443	1443	10. The agency may contract for drug rebate 974
1444	1444	administration, including, but not limited to, calculating 975
1445	1445
1446	1446	HB 1183 2022
1447	1447
1448	1448
1449	1449
1450	1450	CODING: Words stricken are deletions; words underlined are additions.
1451	1451	hb1183-00
1452	1452	Page 40 of 43
1453	1453	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
1454	1454
1455	1455
1456	1456
1457	1457	rebate amounts, invo icing manufacturers, negotiating disputes 976
1458	1458	with manufacturers, and maintaining a database of rebate 977
1459	1459	collections. 978
1460	1460	11. The agency may specify the preferred daily dosing form 979
1461	1461	or strength for the purpose of promoting best practices with 980
1462	1462	regard to the prescrib ing of certain drugs as specified in the 981
1463	1463	General Appropriations Act and ensuring cost -effective 982
1464	1464	prescribing practices. 983
1465	1465	12. The agency may require prior authorization for 984
1466	1466	Medicaid-covered prescribed drugs. The agency may prior -985
1467	1467	authorize the use of a produ ct: 986
1468	1468	a. For an indication not approved in labeling; 987
1469	1469	b. To comply with certain clinical guidelines; or 988
1470	1470	c. If the product has the potential for overuse, misuse, 989
1471	1471	or abuse. 990
1472	1472	991
1473	1473	The agency may require the prescribing professional to provide 992
1474	1474	information about the rationale and supporting medical evidence 993
1475	1475	for the use of a drug. The agency shall post prior 994
1476	1476	authorization, step-edit criteria and protocol, and updates to 995
1477	1477	the list of drugs that are subject to prior authorization on the 996
1478	1478	agency's Internet website within 21 days after the prior 997
1479	1479	authorization and step -edit criteria and protocol and updates 998
1480	1480	are approved by the agency. For purposes of this subparagraph, 999
1481	1481	the term "step-edit" means an automatic electronic review of 1000
1482	1482
1483	1483	HB 1183 2022
1484	1484
1485	1485
1486	1486
1487	1487	CODING: Words stricken are deletions; words underlined are additions.
1488	1488	hb1183-00
1489	1489	Page 41 of 43
1490	1490	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
1491	1491
1492	1492
1493	1493
1494	1494	certain medications subject to prior authorization. 1001
1495	1495	13. The agency, in conjunction with the Pharmaceutical and 1002
1496	1496	Therapeutics Committee, may require age -related prior 1003
1497	1497	authorizations for certain prescribed drugs. The age ncy may 1004
1498	1498	preauthorize the use of a drug for a recipient who may not meet 1005
1499	1499	the age requirement or may exceed the length of therapy for use 1006
1500	1500	of this product as recommended by the manufacturer and approved 1007
1501	1501	by the Food and Drug Administration. Prior authorization may 1008
1502	1502	require the prescribing professional to provide information 1009
1503	1503	about the rationale and supporting medical evidence for the use 1010
1504	1504	of a drug. 1011
1505	1505	14. The agency shall implement a step -therapy prior 1012
1506	1506	authorization approval process for medications excluded from t he 1013
1507	1507	preferred drug list. Medications listed on the preferred drug 1014
1508	1508	list must be used within the previous 12 months before the 1015
1509	1509	alternative medications that are not listed. The step -therapy 1016
1510	1510	prior authorization may require the prescriber to use the 1017
1511	1511	medications of a similar drug class or for a similar medical 1018
1512	1512	indication unless contraindicated in the Food and Drug 1019
1513	1513	Administration labeling. The trial period between the specified 1020
1514	1514	steps may vary according to the medical indication. The step -1021
1515	1515	therapy approval process sh all be developed in accordance with 1022
1516	1516	the committee as stated in s. 409.91195(7) and (8). A drug 1023
1517	1517	product may be approved without meeting the step -therapy prior 1024
1518	1518	authorization criteria if the prescribing physician provides the 1025
1519	1519
1520	1520	HB 1183 2022
1521	1521
1522	1522
1523	1523
1524	1524	CODING: Words stricken are deletions; words underlined are additions.
1525	1525	hb1183-00
1526	1526	Page 42 of 43
1527	1527	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
1528	1528
1529	1529
1530	1530
1531	1531	agency with additional written me dical or clinical documentation 1026
1532	1532	that the product is medically necessary because: 1027
1533	1533	a. There is not a drug on the preferred drug list to treat 1028
1534	1534	the disease or medical condition which is an acceptable clinical 1029
1535	1535	alternative; 1030
1536	1536	b. The alternatives have been inef fective in the treatment 1031
1537	1537	of the beneficiary's disease; or 1032
1538	1538	c. Based on historic evidence and known characteristics of 1033
1539	1539	the patient and the drug, the drug is likely to be ineffective, 1034
1540	1540	or the number of doses have been ineffective. 1035
1541	1541	1036
1542	1542	The agency shall work with the physician to determine the best 1037
1543	1543	alternative for the patient. The agency may adopt rules waiving 1038
1544	1544	the requirements for written clinical documentation for specific 1039
1545	1545	drugs in limited clinical situations. 1040
1546	1546	15. The agency shall implement a return and reuse program 1041
1547	1547	for drugs dispensed by pharmacies to institutional recipients, 1042
1548	1548	which includes payment of a $5 restocking fee for the 1043
1549	1549	implementation and operation of the program. The return and 1044
1550	1550	reuse program shall be implemented electronically and in a 1045
1551	1551	manner that promotes efficiency. The program must permit a 1046
1552	1552	pharmacy to exclude drugs from the program if it is not 1047
1553	1553	practical or cost-effective for the drug to be included and must 1048
1554	1554	provide for the return to inventory of drugs that cannot be 1049
1555	1555	credited or returned in a co st-effective manner. The agency 1050
1556	1556
1557	1557	HB 1183 2022
1558	1558
1559	1559
1560	1560
1561	1561	CODING: Words stricken are deletions; words underlined are additions.
1562	1562	hb1183-00
1563	1563	Page 43 of 43
1564	1564	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
1565	1565
1566	1566
1567	1567
1568	1568	shall determine if the program has reduced the amount of 1051
1569	1569	Medicaid prescription drugs which are destroyed on an annual 1052
1570	1570	basis and if there are additional ways to ensure more 1053
1571	1571	prescription drugs are not destroyed which could saf ely be 1054
1572	1572	reused. 1055
1573	1573	Section 15. Subsection (9) of section 499.067, Florida 1056
1574	1574	Statutes, is amended to read: 1057
1575	1575	499.067 Denial, suspension, or revocation of permit, 1058
1576	1576	certification, or registration. — 1059
1577	1577	(9)(a) The department may deny, suspend, or revoke a 1060
1578	1578	permit under this part if it finds the permittee has not 1061
1579	1579	complied with the reporting requirements of, or knowingly made a 1062
1580	1580	false statement in a report required by, s. 499.0121(14). 1063
1581	1581	(b) The department may deny an application for a renewal 1064
1582	1582	permit or suspend or revok e a permit if it finds the permittee 1065
1583	1583	has not complied with the reporting requirements of, or 1066
1584	1584	knowingly made a false statement in a report required by, s. 1067
1585	1585	499.0121(16). 1068
1586	1586	(c) The department may deny an application for a renewal 1069
1587	1587	permit or suspend or revoke a permit if it finds the permittee 1070
1588	1588	has not complied with the notification or reporting requirements 1071
1589	1589	of, or knowingly made a false statement in a notice or report 1072
1590	1590	required by, s. 499.026(2) or (3), respectively. 1073
1591	1591	Section 16. This act shall take effect July 1, 2022. 1074