Florida Senate - 2024 COMMITTEE AMENDMENT Bill No. SB 1320 Ì587166EÎ587166 LEGISLATIVE ACTION Senate . House Comm: WD . 01/29/2024 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Policy (Calatayud) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Section 465.1861, Florida Statutes, is created 6 to read: 7 465.1861 Ordering and dispensing HIV drugs.— 8 (1) As used in this section, the term: 9 (a) “HIV” means the human immunodeficiency virus. 10 (b) “HIV infection prevention drug” means preexposure 11 prophylaxis, postexposure prophylaxis, and any other drug 12 approved by the United States Food and Drug Administration for 13 the prevention of HIV infection as of March 8, 2024. 14 (c) “HIV postexposure prophylaxis drug” means a drug or 15 drug combination that meets the clinical eligibility 16 recommendations of the United States Centers for Disease Control 17 and Prevention guidelines for antiretroviral treatment following 18 potential exposure to HIV issued as of March 8, 2024. 19 (d) “HIV preexposure prophylaxis drug” means a drug or drug 20 combination that meets the clinical eligibility recommendations 21 of the United States Centers for Disease Control and Prevention 22 guidelines for antiretroviral treatment for the prevention of 23 HIV transmission issued as of March 8, 2024. 24 (2) A pharmacist may screen an adult for HIV exposure and 25 provide the results to that adult, with the advice that the 26 patient should seek further medical consultation or treatment 27 from a physician. 28 (3) A pharmacist may dispense HIV preexposure prophylaxis 29 drugs only pursuant to a valid prescription issued by a licensed 30 health care practitioner authorized by the laws of the state to 31 prescribe such drugs. 32 (4) A pharmacist may order and dispense HIV postexposure 33 prophylaxis drugs only pursuant to a collaborative practice 34 agreement between the pharmacist and a physician licensed under 35 chapter 458 or chapter 459 who practices medicine or osteopathic 36 medicine in the same geographic area as the pharmacist. As used 37 in this subsection, the term “geographic area” means the county 38 or counties, or any portion of the county or counties, within 39 which the pharmacist and the physician provide health care 40 services. 41 (5) A pharmacist who orders and dispenses HIV postexposure 42 prophylaxis drugs pursuant to subsection (4) shall provide the 43 patient with written information advising the patient to seek 44 follow-up care from his or her primary care physician. If the 45 patient indicates that he or she lacks regular access to primary 46 care, the pharmacist must comply with the procedures of the 47 pharmacy’s approved access-to-care plan as provided in 48 subsection (7). 49 (6) Before ordering or dispensing HIV postexposure 50 prophylaxis drugs under this section, a pharmacist must be 51 certified by the board, according to the rules adopted by the 52 board, in consultation with the Board of Medicine and the Board 53 of Osteopathic Medicine. To be certified, a pharmacist must, at 54 a minimum, meet all of the following criteria: 55 (a) Hold an active and unencumbered license to practice 56 pharmacy under this chapter. 57 (b) Be engaged in the active practice of pharmacy. 58 (c) Have earned a degree of doctor of pharmacy or have 59 completed at least 3 years of experience as a licensed 60 pharmacist. 61 (d) Maintain at least $250,000 of liability coverage. A 62 pharmacist who maintains liability coverage pursuant to s. 63 465.1865 or s. 465.1895 satisfies this requirement. 64 (e) Have completed a course approved by the board, in 65 consultation with the Board of Medicine and the Board of 66 Osteopathic Medicine, which includes, at a minimum, instruction 67 on all of the following: 68 1. Performance of patient assessments. 69 2. Point-of-care testing procedures. 70 3. Safe and effective treatment of HIV exposure with HIV 71 infection prevention drugs, including, but not limited to, 72 consideration of the side effects of the drug dispensed and the 73 patient’s diet and activity levels. 74 4. Identification of contraindications. 75 5. Identification of patient comorbidities in individuals 76 with HIV requiring further medical evaluation and treatment, 77 including, but not limited to, cardiovascular disease, lung and 78 liver cancer, chronic obstructive lung disease, and diabetes 79 mellitus. 80 (7) The board shall adopt by rule reasonable and fair 81 minimum standards to ensure that all pharmacies that provide 82 adult screening for HIV exposure submit to the department for 83 approval an access-to-care plan (ACP) for assisting patients to 84 gain access to appropriate care settings when they present to 85 the pharmacy for HIV screening and indicate that they lack 86 regular access to primary care. 87 (a) An ACP must include: 88 1. Procedures to educate such patients about care that 89 would be best provided in a primary care setting and the 90 importance of receiving regular primary care. 91 2. A collaborative partnership with one or more nearby 92 federally qualified health centers, county health departments, 93 or other primary care settings. The goals of such partnership 94 must include, but need not be limited to, identifying patients 95 who have presented to the pharmacy for HIV screening or access 96 to HIV infection prevention drugs, and, if such a patient 97 indicates that he or she lacks regular access to primary care, 98 proactively seeking to establish a relationship between the 99 patient and a federally qualified health center, county health 100 department, or other primary care setting so that the patient 101 develops a medical home at such setting for primary health care 102 services. A pharmacy that establishes one or more collaborative 103 partnerships under this subparagraph may not enter into an 104 arrangement relating to such partnership which would prevent a 105 federally qualified health center, county health department, or 106 other primary care setting from establishing collaborative 107 partnerships with other pharmacies. 108 (b) Effective July 1, 2025, a pharmacy’s ACP must be 109 approved by the department before the pharmacy may receive 110 initial licensure or licensure renewal occurring after that 111 date. A pharmacy with an approved ACP must submit data to the 112 department regarding the implementation and results of its plan 113 as part of the licensure renewal process, or as directed by the 114 department, before each licensure renewal. 115 (8) The board shall adopt rules to implement this section. 116 Section 2. This act shall take effect July 1, 2024. 117 118 ================= T I T L E A M E N D M E N T ================ 119 And the title is amended as follows: 120 Delete everything before the enacting clause 121 and insert: 122 A bill to be entitled 123 An act relating to HIV infection prevention drugs; 124 creating s. 465.1861, F.S.; defining terms; 125 authorizing pharmacists to screen adults for HIV 126 exposure and provide the results to such adults, with 127 advice to seek consultation or treatment from a 128 physician; authorizing pharmacists to dispense HIV 129 preexposure prophylaxis drugs only pursuant to a 130 prescription; authorizing pharmacists to order and 131 dispense HIV postexposure prophylaxis drugs only 132 pursuant to a collaborative practice agreement with a 133 physician; defining the term “geographic area”; 134 requiring such pharmacists to provide certain written 135 information when dispensing such drugs to patients; 136 requiring pharmacists to comply with certain 137 procedures under certain circumstances; requiring 138 pharmacists to be certified by the Board of Pharmacy 139 before ordering or dispensing HIV postexposure 140 prophylaxis drugs; requiring the board, in 141 consultation with the Board of Medicine and the Board 142 of Osteopathic Medicine, to adopt rules for such 143 certification; specifying minimum requirements for the 144 certification; requiring the board to adopt by rule 145 certain minimum standards to ensure that pharmacies 146 providing adult screenings for HIV exposure submit to 147 the department for approval an access-to-care plan 148 (ACP) for a specified purpose; specifying requirements 149 for ACPs; requiring that, beginning on a specified 150 date, such ACPs be approved before a license may be 151 issued or renewed; requiring such pharmacies to submit 152 specified data to the department as part of the 153 licensure renewal process and update their ACPs as 154 needed, or as directed by the department, before each 155 licensure renewal; requiring the board to adopt rules; 156 providing an effective date.