Florida 2022 Regular Session

Florida House Bill H1221 Compare Versions

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

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3	3	HB 1221 2022
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7	7	CODING: Words stricken are deletions; words underlined are additions.
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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 antiretroviral drugs; creating s. 2
16	16	465.1861, F.S.; defining terms; authorizing 3
17	17	pharmacists to order and dispense preexposure and 4
18	18	postexposure prophylaxes to patients without 5
19	19	prescriptions under certain circumstances; requiring 6
20	20	pharmacists to complete specified training before 7
21	21	ordering or dispensing such prophylaxes to patients 8
22	22	without prescriptions; authorizing pharmacists to 9
23	23	order and dispense specified supplies of preexposure 10
24	24	prophylaxes and full courses of postexposure 11
25	25	prophylaxes to patients without prescriptions if 12
26	26	certain conditions are met; authorizing the Board of 13
27	27	Pharmacy, in consultation with the Board of Medicine, 14
28	28	the Department of He alth, and other relevant 15
29	29	stakeholders, to adopt rules; creating s. 627.4291, 16
30	30	F.S.; defining terms; prohibiting certain health 17
31	31	insurers from requiring prior authorizations or step -18
32	32	therapy protocols for certain antiretroviral drugs; 19
33	33	providing an exception; p rohibiting health insurers 20
34	34	from refusing to cover, or allowing pharmacy benefit 21
35	35	managers to refuse to cover, preexposure and 22
36	36	postexposure prophylaxes under certain circumstances; 23
37	37	providing an effective date. 24
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40	40	HB 1221 2022
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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	Be It Enacted by the Legislature of the Sta te of Florida: 26
52	52	27
53	53	Section 1. Section 465.1861, Florida Statutes, is created 28
54	54	to read: 29
55	55	465.1861 Antiretroviral drugs. — 30
56	56	(1) As used in this section, the term: 31
57	57	(a) "HIV" means the human immunodeficiency virus. 32
58	58	(b) "Postexposure prophylaxis" means any of the following: 33
59	59	1. A fixed-dose combination of 300 milligrams of tenofovir 34
60	60	disoproxil fumarate with 200 milligrams of emtricitabine, taken 35
61	61	once daily, in combination with either 400 milligrams of 36
62	62	raltegravir, taken twice daily, or 50 milligrams of 37
63	63	dolutegravir, taken once daily. 38
64	64	2. A fixed-dose combination of 300 milligrams of tenofovir 39
65	65	disoproxil fumarate with 200 milligrams emtricitabine, taken 40
66	66	once daily, in combination with a fixed -dose combination of 800 41
67	67	milligrams of darunavir and 100 milligram s of ritonavir, taken 42
68	68	once daily. 43
69	69	3. Any other drug or drug combination deemed by the board 44
70	70	to meet the same clinical eligibility recommendations of the 45
71	71	United States Centers for Disease Control and Prevention 46
72	72	guidelines for antiretroviral postexposure p rophylaxis after 47
73	73	sexual, injection drug use, or other nonoccupational exposure to 48
74	74	HIV. 49
75	75	(c) "Preexposure prophylaxis" means a fixed -dose 50
76	76
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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	combination of 300 milligrams of tenofovir disoproxil fumarate 51
89	89	with 200 milligrams of emtricitabine, or another drug o r 52
90	90	combination of drugs which the board deems to meet the clinical 53
91	91	eligibility recommendations of the United States Centers for 54
92	92	Disease Control and Prevention guidelines for preexposure 55
93	93	prophylaxis for the prevention of HIV infection. 56
94	94	(2) Notwithstanding any other law, a pharmacist may order 57
95	95	or dispense an HIV preexposure or postexposure prophylaxis to a 58
96	96	patient without a prescription in accordance with this section. 59
97	97	Before ordering or dispensing such medicinal drug, a pharmacist 60
98	98	must first complete a trai ning program approved by the board 61
99	99	which includes all of the following: 62
100	100	(a) Training in the use of preexposure and postexposure 63
101	101	prophylaxis. 64
102	102	(b) Information about any financial assistance programs 65
103	103	for preexposure and postexposure prophylaxis. 66
104	104	(c) Any other topic the board deems appropriate. The board 67
105	105	shall consult with the Board of Medicine, the department, and 68
106	106	other relevant stakeholders when making such determinations. 69
107	107	(3) A pharmacist may order or dispense up to two 30 -day 70
108	108	supplies of preexposure prophylaxis to a patient without a 71
109	109	prescription if all of the following conditions are met: 72
110	110	(a) The patient is HIV negative, as documented by a 73
111	111	negative HIV test result, obtained within the preceding 7 days, 74
112	112	from an HIV antigen or antibody test, an anti body-only test, or 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	a rapid, point-of-care fingerstick blood test approved by the 76
126	126	federal Food and Drug Administration. If the patient does not 77
127	127	provide evidence of a negative HIV test in accordance with this 78
128	128	paragraph, the pharmacist must order an HIV test. If the test 79
129	129	results are not transmitted directly to the pharmacist, the 80
130	130	pharmacist must verify the test results to his or her 81
131	131	satisfaction. If the patient tests positive for HIV infection, 82
132	132	the pharmacist or person administering the test must direct the 83
133	133	patient to a primary care provider and provide to the patient a 84
134	134	list of available providers and clinics in the region. 85
135	135	(b) The patient does not report any signs or symptoms of 86
136	136	acute HIV infection, as indicated on a self -reported checklist 87
137	137	of acute HIV infection signs and symptoms which was provided by 88
138	138	the pharmacist. 89
139	139	(c) The patient does not report taking any contraindicated 90
140	140	medications. 91
141	141	(d) The pharmacist has not ordered two 30 -day supplies of 92
142	142	preexposure prophylaxis for the patient without a prescript ion 93
143	143	in the preceding 2-year period. 94
144	144	(e) The pharmacist provides counseling to the patient on 95
145	145	the ongoing use of preexposure prophylaxis, consistent with 96
146	146	guidelines issued by the United States Centers for Disease 97
147	147	Control and Prevention, including, but not limited to, education 98
148	148	about side effects, safety during pregnancy and breastfeeding, 99
149	149	adherence to recommended dosing, and the importance of timely 100
150	150
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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	testing and treatment, as applicable, for HIV, renal function, 101
163	163	hepatitis B, hepatitis C, sexually transmitte d diseases, and 102
164	164	pregnancy for individuals of child -bearing capacity. A 103
165	165	pharmacist may not allow a patient to waive this counseling. 104
166	166	(f) The pharmacist informs the patient that the patient 105
167	167	must be seen by a primary care provider to receive subsequent 106
168	168	prescriptions for preexposure prophylaxis and that a pharmacist 107
169	169	may order only up to two 30 -day supplies of preexposure 108
170	170	prophylaxis without a prescription in one 2 -year period for each 109
171	171	patient. 110
172	172	(g) The pharmacist documents and maintains in the pharmacy 111
173	173	records system a record of each 30 -day supply of preexposure 112
174	174	prophylaxis ordered or dispensed to the patient without a 113
175	175	prescription. The pharmacist or pharmacy must maintain such 114
176	176	records for at least 4 years. 115
177	177	(h) The pharmacist notifies the patient's primary care 116
178	178	provider that the pharmacist ordered or dispensed preexposure 117
179	179	prophylaxis to the patient in accordance with this section. If 118
180	180	the patient does not have a primary care provider or refuses to 119
181	181	consent to such notification, the pharmacist must provide the 120
182	182	patient a list of physicians, surgeons, clinics, or other health 121
183	183	care providers to contact regarding ongoing care for preexposure 122
184	184	prophylaxis. 123
185	185	(4) A pharmacist may order or dispense a full course of 124
186	186	postexposure prophylaxis to a patient without a prescri ption if 125
187	187
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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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199	199	all of the following conditions are met: 126
200	200	(a) The pharmacist screens the patient and determines that 127
201	201	the patient's exposure occurred within the previous 72 hours and 128
202	202	the patient otherwise meets the clinical criteria for 129
203	203	postexposure prophylaxis c onsistent with the applicable 130
204	204	guidelines issued by the United States Centers for Disease 131
205	205	Control and Prevention. 132
206	206	(b) The pharmacist provides to the patient HIV testing 133
207	207	that is deemed a waived test under the federal Clinical 134
208	208	Laboratory Improvement Amendme nts of 1988 or the patient is 135
209	209	willing to undergo HIV testing in accordance with s. 381.004. If 136
210	210	the patient refuses to undergo HIV testing but is otherwise 137
211	211	eligible for postexposure prophylaxis under this section, the 138
212	212	pharmacist may order or dispense postex posure prophylaxis to the 139
213	213	patient. 140
214	214	(c) The pharmacist provides counseling to the patient on 141
215	215	the use of postexposure prophylaxis, consistent with guidelines 142
216	216	issued by the United States Centers for Disease Control and 143
217	217	Prevention, including, but not limited to, education about side 144
218	218	effects, safety during pregnancy and breastfeeding, adherence to 145
219	219	recommended dosing, and the importance of timely testing and 146
220	220	treatment, as applicable, for HIV and sexually transmitted 147
221	221	diseases. The pharmacist must also inform the patient of the 148
222	222	availability of preexposure prophylaxis for persons who are at 149
223	223	substantial risk of acquiring HIV. A pharmacist may not allow a 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	patient to waive this counseling. 151
237	237	(d) The pharmacist notifies the patient's primary care 152
238	238	provider that the phar macist ordered or dispensed the 153
239	239	postexposure prophylaxis in accordance with this section. If the 154
240	240	patient does not have a primary care provider or refuses to 155
241	241	consent to such notification, the pharmacist must provide the 156
242	242	patient a list of physicians, surgeon s, clinics, or other health 157
243	243	care providers to contact regarding followup care for 158
244	244	postexposure prophylaxis. 159
245	245	(5) The board, in consultation with the Board of Medicine, 160
246	246	the department, and other relevant stakeholders, may adopt rules 161
247	247	to implement this sect ion. 162
248	248	Section 2. Section 627.4291, Florida Statutes, is created 163
249	249	to read: 164
250	250	627.4291 Coverage of antiretroviral drugs. — 165
251	251	(1) As used in this section, the term: 166
252	252	(a) "AIDS" means acquired immune deficiency syndrome. 167
253	253	(b) "Health insurer" means an autho rized insurer offering 168
254	254	health insurance as defined in s. 624.603, a managed care plan 169
255	255	as defined in s. 409.962, or a health maintenance organization 170
256	256	as defined in s. 641.19(12). 171
257	257	(c) "HIV" means the human immunodeficiency virus. 172
258	258	(d) "Insured" means a pe rson who is covered under a policy 173
259	259	delivered or issued for delivery in this state by a health 174
260	260	insurer. 175
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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	(e) "Prior authorization" means a process by which an 176
274	274	insured does not receive coverage for a particular prescription 177
275	275	drug until the insured's health c are provider submits to the 178
276	276	insured's health insurer a request for approval and the health 179
277	277	insurer determines that the prescription drug is covered by the 180
278	278	insured's policy. 181
279	279	(f) "Step-therapy protocol" means a protocol or program 182
280	280	that establishes the spec ific sequence in which prescription 183
281	281	drugs determined as medically appropriate for an insured for a 184
282	282	specified medical condition are covered by a policy. 185
283	283	(2) Notwithstanding any other law, a health insurer 186
284	284	providing major medical or similar comprehensive c overage or 187
285	285	benefits to residents in this state on or after July 1, 2022, 188
286	286	may not require prior authorization or a step -therapy protocol 189
287	287	under the policy for a covered antiretroviral drug that is 190
288	288	medically necessary for the prevention of HIV or AIDS, 191
289	289	including, but not limited to, preexposure and postexposure 192
290	290	prophylaxis, except as provided in subsection (3). 193
291	291	(3) If the federal Food and Drug Administration has 194
292	292	approved one or more therapeutic equivalents of a drug, device, 195
293	293	or product for the prevention of HIV or AIDS, a health insurer 196
294	294	is not required to cover all of the therapeutically equivalent 197
295	295	versions without prior authorization or step -therapy protocols 198
296	296	if at least one therapeutically equivalent version is covered 199
297	297	without prior authorization or a step -therapy protocol. 200
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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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310	310	(4) A health insurer may not refuse to cover, or allow a 201
311	311	pharmacy benefit manager to refuse to cover, preexposure or 202
312	312	postexposure prophylaxis solely on the basis that it was ordered 203
313	313	or dispensed by a licensed pharmacist in accordance wi th s. 204
314	314	465.1861. 205
315	315	Section 3. This act shall take effect July 1, 2022. 206