HB 1221 2022
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hb1221-00
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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
A bill to be entitled 1
An act relating to antiretroviral drugs; creating s. 2
465.1861, F.S.; defining terms; authorizing 3
pharmacists to order and dispense preexposure and 4
postexposure prophylaxes to patients without 5
prescriptions under certain circumstances; requiring 6
pharmacists to complete specified training before 7
ordering or dispensing such prophylaxes to patients 8
without prescriptions; authorizing pharmacists to 9
order and dispense specified supplies of preexposure 10
prophylaxes and full courses of postexposure 11
prophylaxes to patients without prescriptions if 12
certain conditions are met; authorizing the Board of 13
Pharmacy, in consultation with the Board of Medicine, 14
the Department of He alth, and other relevant 15
stakeholders, to adopt rules; creating s. 627.4291, 16
F.S.; defining terms; prohibiting certain health 17
insurers from requiring prior authorizations or step -18
therapy protocols for certain antiretroviral drugs; 19
providing an exception; p rohibiting health insurers 20
from refusing to cover, or allowing pharmacy benefit 21
managers to refuse to cover, preexposure and 22
postexposure prophylaxes under certain circumstances; 23
providing an effective date. 24
25
HB 1221 2022
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hb1221-00
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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
Be It Enacted by the Legislature of the Sta te of Florida: 26
27
Section 1. Section 465.1861, Florida Statutes, is created 28
to read: 29
465.1861 Antiretroviral drugs. — 30
(1) As used in this section, the term: 31
(a) "HIV" means the human immunodeficiency virus. 32
(b) "Postexposure prophylaxis" means any of the following: 33
1. A fixed-dose combination of 300 milligrams of tenofovir 34
disoproxil fumarate with 200 milligrams of emtricitabine, taken 35
once daily, in combination with either 400 milligrams of 36
raltegravir, taken twice daily, or 50 milligrams of 37
dolutegravir, taken once daily. 38
2. A fixed-dose combination of 300 milligrams of tenofovir 39
disoproxil fumarate with 200 milligrams emtricitabine, taken 40
once daily, in combination with a fixed -dose combination of 800 41
milligrams of darunavir and 100 milligram s of ritonavir, taken 42
once daily. 43
3. Any other drug or drug combination deemed by the board 44
to meet the same clinical eligibility recommendations of the 45
United States Centers for Disease Control and Prevention 46
guidelines for antiretroviral postexposure p rophylaxis after 47
sexual, injection drug use, or other nonoccupational exposure to 48
HIV. 49
(c) "Preexposure prophylaxis" means a fixed -dose 50
HB 1221 2022
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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
combination of 300 milligrams of tenofovir disoproxil fumarate 51
with 200 milligrams of emtricitabine, or another drug o r 52
combination of drugs which the board deems to meet the clinical 53
eligibility recommendations of the United States Centers for 54
Disease Control and Prevention guidelines for preexposure 55
prophylaxis for the prevention of HIV infection. 56
(2) Notwithstanding any other law, a pharmacist may order 57
or dispense an HIV preexposure or postexposure prophylaxis to a 58
patient without a prescription in accordance with this section. 59
Before ordering or dispensing such medicinal drug, a pharmacist 60
must first complete a trai ning program approved by the board 61
which includes all of the following: 62
(a) Training in the use of preexposure and postexposure 63
prophylaxis. 64
(b) Information about any financial assistance programs 65
for preexposure and postexposure prophylaxis. 66
(c) Any other topic the board deems appropriate. The board 67
shall consult with the Board of Medicine, the department, and 68
other relevant stakeholders when making such determinations. 69
(3) A pharmacist may order or dispense up to two 30 -day 70
supplies of preexposure prophylaxis to a patient without a 71
prescription if all of the following conditions are met: 72
(a) The patient is HIV negative, as documented by a 73
negative HIV test result, obtained within the preceding 7 days, 74
from an HIV antigen or antibody test, an anti body-only test, or 75
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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
a rapid, point-of-care fingerstick blood test approved by the 76
federal Food and Drug Administration. If the patient does not 77
provide evidence of a negative HIV test in accordance with this 78
paragraph, the pharmacist must order an HIV test. If the test 79
results are not transmitted directly to the pharmacist, the 80
pharmacist must verify the test results to his or her 81
satisfaction. If the patient tests positive for HIV infection, 82
the pharmacist or person administering the test must direct the 83
patient to a primary care provider and provide to the patient a 84
list of available providers and clinics in the region. 85
(b) The patient does not report any signs or symptoms of 86
acute HIV infection, as indicated on a self -reported checklist 87
of acute HIV infection signs and symptoms which was provided by 88
the pharmacist. 89
(c) The patient does not report taking any contraindicated 90
medications. 91
(d) The pharmacist has not ordered two 30 -day supplies of 92
preexposure prophylaxis for the patient without a prescript ion 93
in the preceding 2-year period. 94
(e) The pharmacist provides counseling to the patient on 95
the ongoing use of preexposure prophylaxis, consistent with 96
guidelines issued by the United States Centers for Disease 97
Control and Prevention, including, but not limited to, education 98
about side effects, safety during pregnancy and breastfeeding, 99
adherence to recommended dosing, and the importance of timely 100
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testing and treatment, as applicable, for HIV, renal function, 101
hepatitis B, hepatitis C, sexually transmitte d diseases, and 102
pregnancy for individuals of child -bearing capacity. A 103
pharmacist may not allow a patient to waive this counseling. 104
(f) The pharmacist informs the patient that the patient 105
must be seen by a primary care provider to receive subsequent 106
prescriptions for preexposure prophylaxis and that a pharmacist 107
may order only up to two 30 -day supplies of preexposure 108
prophylaxis without a prescription in one 2 -year period for each 109
patient. 110
(g) The pharmacist documents and maintains in the pharmacy 111
records system a record of each 30 -day supply of preexposure 112
prophylaxis ordered or dispensed to the patient without a 113
prescription. The pharmacist or pharmacy must maintain such 114
records for at least 4 years. 115
(h) The pharmacist notifies the patient's primary care 116
provider that the pharmacist ordered or dispensed preexposure 117
prophylaxis to the patient in accordance with this section. If 118
the patient does not have a primary care provider or refuses to 119
consent to such notification, the pharmacist must provide the 120
patient a list of physicians, surgeons, clinics, or other health 121
care providers to contact regarding ongoing care for preexposure 122
prophylaxis. 123
(4) A pharmacist may order or dispense a full course of 124
postexposure prophylaxis to a patient without a prescri ption if 125
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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
all of the following conditions are met: 126
(a) The pharmacist screens the patient and determines that 127
the patient's exposure occurred within the previous 72 hours and 128
the patient otherwise meets the clinical criteria for 129
postexposure prophylaxis c onsistent with the applicable 130
guidelines issued by the United States Centers for Disease 131
Control and Prevention. 132
(b) The pharmacist provides to the patient HIV testing 133
that is deemed a waived test under the federal Clinical 134
Laboratory Improvement Amendme nts of 1988 or the patient is 135
willing to undergo HIV testing in accordance with s. 381.004. If 136
the patient refuses to undergo HIV testing but is otherwise 137
eligible for postexposure prophylaxis under this section, the 138
pharmacist may order or dispense postex posure prophylaxis to the 139
patient. 140
(c) The pharmacist provides counseling to the patient on 141
the use of postexposure prophylaxis, consistent with guidelines 142
issued by the United States Centers for Disease Control and 143
Prevention, including, but not limited to, education about side 144
effects, safety during pregnancy and breastfeeding, adherence to 145
recommended dosing, and the importance of timely testing and 146
treatment, as applicable, for HIV and sexually transmitted 147
diseases. The pharmacist must also inform the patient of the 148
availability of preexposure prophylaxis for persons who are at 149
substantial risk of acquiring HIV. A pharmacist may not allow a 150
HB 1221 2022
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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
patient to waive this counseling. 151
(d) The pharmacist notifies the patient's primary care 152
provider that the phar macist ordered or dispensed the 153
postexposure prophylaxis in accordance with this section. If the 154
patient does not have a primary care provider or refuses to 155
consent to such notification, the pharmacist must provide the 156
patient a list of physicians, surgeon s, clinics, or other health 157
care providers to contact regarding followup care for 158
postexposure prophylaxis. 159
(5) The board, in consultation with the Board of Medicine, 160
the department, and other relevant stakeholders, may adopt rules 161
to implement this sect ion. 162
Section 2. Section 627.4291, Florida Statutes, is created 163
to read: 164
627.4291 Coverage of antiretroviral drugs. — 165
(1) As used in this section, the term: 166
(a) "AIDS" means acquired immune deficiency syndrome. 167
(b) "Health insurer" means an autho rized insurer offering 168
health insurance as defined in s. 624.603, a managed care plan 169
as defined in s. 409.962, or a health maintenance organization 170
as defined in s. 641.19(12). 171
(c) "HIV" means the human immunodeficiency virus. 172
(d) "Insured" means a pe rson who is covered under a policy 173
delivered or issued for delivery in this state by a health 174
insurer. 175
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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
(e) "Prior authorization" means a process by which an 176
insured does not receive coverage for a particular prescription 177
drug until the insured's health c are provider submits to the 178
insured's health insurer a request for approval and the health 179
insurer determines that the prescription drug is covered by the 180
insured's policy. 181
(f) "Step-therapy protocol" means a protocol or program 182
that establishes the spec ific sequence in which prescription 183
drugs determined as medically appropriate for an insured for a 184
specified medical condition are covered by a policy. 185
(2) Notwithstanding any other law, a health insurer 186
providing major medical or similar comprehensive c overage or 187
benefits to residents in this state on or after July 1, 2022, 188
may not require prior authorization or a step -therapy protocol 189
under the policy for a covered antiretroviral drug that is 190
medically necessary for the prevention of HIV or AIDS, 191
including, but not limited to, preexposure and postexposure 192
prophylaxis, except as provided in subsection (3). 193
(3) If the federal Food and Drug Administration has 194
approved one or more therapeutic equivalents of a drug, device, 195
or product for the prevention of HIV or AIDS, a health insurer 196
is not required to cover all of the therapeutically equivalent 197
versions without prior authorization or step -therapy protocols 198
if at least one therapeutically equivalent version is covered 199
without prior authorization or a step -therapy protocol. 200
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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
(4) A health insurer may not refuse to cover, or allow a 201
pharmacy benefit manager to refuse to cover, preexposure or 202
postexposure prophylaxis solely on the basis that it was ordered 203
or dispensed by a licensed pharmacist in accordance wi th s. 204
465.1861. 205
Section 3. This act shall take effect July 1, 2022. 206