Florida Senate - 2022 SB 1636 By Senator Cruz 18-01326-22 20221636__ Page 1 of 7 CODING: Words stricken are deletions; words underlined are additions. 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 HIV preexposure and 4 postexposure prophylaxis drugs without a prescription 5 under certain circumstances; requiring pharmacists to 6 complete specified training before ordering or 7 dispensing such drugs without a prescription; 8 authorizing pharmacists to order and dispense a 9 specified supply of preexposure prophylaxis or a full 10 course of postexposure prophylaxis, as applicable, to 11 patients without prescriptions if certain conditions 12 are met; authorizing the Board of Pharmacy, in 13 consultation with the Board of Medicine, the 14 Department of Health, and other relevant stakeholders, 15 to adopt rules; creating s. 627.4291, F.S.; defining 16 terms; prohibiting certain health insurers from 17 requiring prior authorization or step-therapy 18 protocols for certain antiretroviral drugs; providing 19 an exception; prohibiting health insurers from 20 refusing to cover, or allowing pharmacy benefit 21 managers to refuse to cover, preexposure or 22 postexposure prophylaxis drugs under certain 23 circumstances; providing an effective date. 24 25 Be It Enacted by the Legislature of the State of Florida: 26 27

Section

Section 465.1861, Florida Statutes, is created 28 to read: 29

Florida Senate - 2022 SB 1636 18-01326-22 20221636__ Page 2 of 7 CODING: Words stricken are deletions; words underlined are additions. 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 milligrams 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 prophylaxis after 47 sexual, injection drug use, or other nonoccupational exposure to 48 HIV. 49 (c) “Preexposure prophylaxis” means a fixed-dose 50 combination of 300 milligrams of tenofovir disoproxil fumarate 51 with 200 milligrams of emtricitabine, or another drug or 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 58

Florida Senate - 2022 SB 1636 18-01326-22 20221636__ Page 3 of 7 CODING: Words stricken are deletions; words underlined are additions. without a prescription in accordance with this section. Before 59 ordering or dispensing such medicinal drug, a pharmacist must 60 first complete a training program approved by the board which 61 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 for 65 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 antibody-only test, or 75 a rapid, point-of-care fingerstick blood test approved by the 76 United States Food and Drug Administration. If the patient does 77 not provide evidence of a negative HIV test in accordance with 78 this paragraph, the pharmacist must order an HIV tes t. If the 79 test 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

Florida Senate - 2022 SB 1636 18-01326-22 20221636__ Page 4 of 7 CODING: Words stricken are deletions; words underlined are additions. of acute HIV infection signs and symptoms provided by the 88 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 prescription 93 in the preceding 2-year period. 94 (

e) The pharmacist provides counseling to the patient on 95 the ongoing use of preexposure prophylaxis, to include, at a 96 minimum, education about side effects, safety during pregnancy 97 and breastfeeding, adherence to recommended dosing, a nd the 98 importance of timely testing and treatment, as applicable, for 99 HIV, renal function, hepatitis B, hepatitis C, sexually 100 transmitted diseases, and pregnancy for individuals of child -101 bearing capacity. A pharmacist may not allow a patient to waive 102 this counseling. 103 (

f) The pharmacist informs the patient that he or she must 104 be seen by a primary care provider to receive subsequent 105 prescriptions for preexposure prophylaxis and that a pharmacist 106 may order only up to two 30-day supplies without a prescription 107 in one 2-year period for each patient. 108 (

g) The pharmacist documents and maintains in the pharmacy 109 records system a record of each 30-day supply of preexposure 110 prophylaxis ordered or dispensed to the patient without a 111 prescription. The pharmacist or pharmacy must maintain such 112 records for at least 4 years. 113 (

h) The pharmacist notifies the patient’s primary care 114 provider that the pharmacist ordered or dispensed preexposure 115 prophylaxis to the patient in accordance with this section. If 116

Florida Senate - 2022 SB 1636 18-01326-22 20221636__ Page 5 of 7 CODING: Words stricken are deletions; words underlined are additions. the patient does not have a primary care provider or refuses 117 consent to notify the patient’s primary care provider, the 118 pharmacist must provide the patient a list of physicians, 119 surgeons, clinics, or other health care service providers to 120 contact regarding ongoing care for preexposure prophylaxis. 121

(4) A pharmacist may order or dispense a full course of 122 postexposure prophylaxis to a patient without a prescription if 123 all of the following conditions are met: 124 (

a) The pharmacist screens the patient and determines that 125 the exposure occurred within the previous 72 hours and the 126 patient otherwise meets the clinical criteria for postexposure 127 prophylaxis consistent with the applicable guidelines issued by 128 the United States Centers for Disease Control and Prevention . 129 (

b) The pharmacist provides to the patient HIV testing that 130 is deemed a waived test under the federal Clinical Laboratory 131 Improvement Amendments of 1988 or the patient is willing to 132 undergo HIV testing in accordance with s. 381.004. If the 133 patient refuses to undergo HIV testing but is otherwise eligible 134 for postexposure prophylaxis under this section, the pharmacist 135 may order or dispense postexposure prophylaxis to the patient. 136 (

c) The pharmacist provides counseling to the patient on 137 the use of postexposure prophylaxis, consistent with guidelines 138 issued by the United States Centers for Disease Control and 139 Prevention, to include, at a minimum, education about side 140 effects, safety during pregnancy and breastfeeding, adherence to 141 recommended dosing, and the importance of timely testing and 142 treatment, as applicable, for HIV and sexually transmitted 143 diseases. The pharmacist must also inform the patient of the 144 availability of preexposure prophylaxis for persons who are at 145

Florida Senate - 2022 SB 1636 18-01326-22 20221636__ Page 6 of 7 CODING: Words stricken are deletions; words underlined are additions. substantial risk of acquiring HIV. A pharmacist may not allow a 146 patient to waive this counseling. 147 (

d) The pharmacist notifies the patient’s primary care 148 provider that the pharmacist ordered or dispensed the 149 postexposure prophylaxis in accordance with this

section . If the 150 patient does not have a primary care provider or refuses consent 151 to notify the patient’s primary care provider, the pharmacist 152 must provide the patient a list of physicians, surgeons, 153 clinics, or other health care service providers to contact 154 regarding follow-up care for postexposure prophylaxis. 155

(5) The board, in consultation with the Board of Medicine, 156 the department, and other relevant stakeholders, may adopt rules 157 to implement this section. 158

Section

Section 627.4291, Florida Statutes, is created 159 to read: 160 627.4291 Coverage of antiretroviral drugs.— 161

(1) As used in this section, the term: 162 (a) “AIDS” means acquired immune deficiency syndrome. 163 (b) “Health insurer” means an authorized insurer offering 164 health insurance as defined in s. 624.603, a managed care plan 165 as defined in s. 409.962, or a health maintenance organization 166 as defined in s. 641.19(12). 167 (c) “HIV” means the human immunodeficiency virus. 168 (d) “Insured” means a person who is covered under a policy 169 delivered or issued for delivery in this state by a health 170 insurer. 171 (e) “Prior authorization” means a process by which an 172 insured does not receive coverage for a particular prescription 173 drug until the insured’s health care provider submits to the 174

Florida Senate - 2022 SB 1636 18-01326-22 20221636__ Page 7 of 7 CODING: Words stricken are deletions; words underlined are additions. insured’s health insurer a request for approval and the health 175 insurer determines that the prescription drug is covered by the 176 insured’s policy. 177 (f) “Step-therapy protocol” means a protocol or program 178 that establishes the specific sequence in which prescription 179 drugs determined as medically appropriate for an insured for a 180 specified medical condition are covered by a policy. 181

(2) Notwithstanding any other law, a health insurer 182 providing major medical or similar comprehensive coverage or 183 benefits to residents in this state on or after July 1, 2022, 184 may not require prior authorization or a step-therapy protocol 185 under the policy for a covered antiretroviral drug that is 186 medically necessary for the prevention of HIV or AIDS, 187 including, but not limited to, preexposure and postexposure 188 prophylaxis, except as provided in subsection (3). 189

(3) If the United States Food and Drug Administration has 190 approved one or more therapeutic equivalents of a drug, device, 191 or product for the prevention of HIV or AIDS, a health insurer 192 is not required to cover all of the therapeutically equivalent 193 versions without prior authorization or step-therapy protocols 194 if at least one therapeutically equivalent version is covered 195 without prior authorization or a step-therapy protocol. 196

(4) A health insurer may not refuse to cover, or allow a 197 pharmacy benefit manager to refuse to cover, preexposure or 198 postexposure prophylaxis solely on the basis that it was ordered 199 or dispensed by a licensed pharmacist in accordance with s. 200 465.1861. 201

Section 3. This act shall take effect July 1, 2022. 202