Florida Senate - 2024 SB 1750 By Senator Gruters 22-01113B-24 20241750__ 1 A bill to be entitled 2 An act relating to international drug reference 3 pricing; creating s. 499.044, F.S.; providing 4 legislative policy; requiring prescription drug 5 manufacturer permitholders to annually report certain 6 international price data to the Agency for Health Care 7 Administration; providing for administrative 8 enforcement by a specified fine and permit suspension; 9 requiring the agency to contract with an entity to 10 designate reference price source countries and 11 establish the reference prices for prescription drugs 12 based on certain criteria; requiring the agency 13 contractor to reevaluate the designated reference 14 prices source countries annually and revise, as 15 needed; requiring the agency contractor to weigh the 16 reference price benchmark value of such countries in 17 two or more tiers, using specified criteria; providing 18 applicability; defining the term “real gross domestic 19 product per capita”; requiring the agency contractor 20 to analyze specified data to compare prices among 21 source countries using a specified exchange rate 22 source; requiring the agency contractor to establish 23 the reference price for prescribed drugs or products; 24 requiring that such price be the lowest price after 25 making certain adjustments; requiring the agency 26 contractor to update the reference prices annually and 27 permitting reevaluation and updates at any time in 28 certain circumstances; requiring the agency contractor 29 to provide the reference prices by a specified date 30 each year; requiring the agency to publish the prices 31 online within a specified time; amending s. 465.0244, 32 F.S.; requiring pharmacies to charge no more than the 33 reference price for cash-paying patients; providing 34 applicability; amending s. 627.6044, F.S.; requiring 35 certain health insurers to provide reimbursement for 36 certain prescription drugs no higher than the 37 reference price; providing applicability; requiring 38 health insurers to use certain savings to offset 39 certain payer costs; requiring each health insurer to 40 document anticipated savings and premium reductions in 41 rate filings following the availability of reference 42 prices; requiring each health insurer to assess the 43 actuarial effect of the reference pricing program for 44 each insurer product for each plan year; requiring 45 each health insurer to submit an annual report on the 46 assessed effect of such program to the Office of 47 Insurance Regulation or the Agency for Health Care 48 Administration; providing applicability; requiring the 49 Office of Insurance Regulation and the Agency for 50 Health Care Administration to annually submit a joint 51 report to the Governor and the Legislature by a 52 specified date; amending s. 641.30, F.S.; requiring 53 every health maintenance organization to comply with 54 the provisions of a specified section; providing an 55 effective date. 56 57 Be It Enacted by the Legislature of the State of Florida: 58 59 Section 1. Section 499.044, Florida Statutes, is created to 60 read: 61 499.044 International Drug Reference Pricing.— 62 (1) It is the policy of the state that patients and third 63 party payers in the state should not pay more for prescription 64 drugs than those in international markets. 65 (2) Beginning October 1, 2025, each prescription drug 66 manufacturer permitholder and nonresident prescription drug 67 manufacturer permitholder shall annually report international 68 prescription drug price data to the Agency for Health Care 69 Administration. 70 (a) Permitholders shall report the actual outpatient 71 payment or reimbursement amounts for each prescribed drug in 72 each reference price source country identified under this 73 subsection, including amounts paid by both third- party payers 74 such as insurers and government benefit programs and by 75 individual consumers not using third-party payers, net of 76 rebates and other forms of discounts. Permitholders may report 77 the average payment amounts for each drug for a reference price 78 source country, if weighted by utilization volume and fully 79 documented to the agency. 80 (b) Permitholders may provide supplemental pricing data at 81 any time during the year, based on a pricing in a reference 82 price source country. 83 (c) Permitholders shall report the data in a format 84 established by the agency in consultation with the contractor 85 established under this subsection. 86 (d) Failure to timely report required data shall result in 87 a fine of $10,000 a day for the first 30 days, and permit 88 suspension thereafter until compliance is achieved. 89 (3) The agency shall contract with an entity to designate 90 reference price source countries and analyze the data submitted 91 under subsection (2) to establish the reference price for each 92 prescribed drug or product. The agency contractor shall 93 reevaluate the designated reference price source countries 94 annually and revise, as needed. The agency contractor shall 95 weigh the reference price benchmark value of the selected 96 reference price source countries in two or more tiers, using an 97 established index measuring the level of health care system 98 market orientation in each country. 99 (a) Reference price source countries shall include only 100 countries with a real gross domestic product per capita of at 101 least 40 percent of the United States gross domestic product per 102 capita, using international sales, volume, and pricing data for 103 each country. For the purposes of this subsection, “real gross 104 domestic product per capita” means a country’s most recent 105 estimate based on purchasing power parity for that country 106 available in the most recent edition of the United States 107 Central Intelligence Agency World Factbook. Countries with 108 single-payer health systems, which include whole-market 109 government price-setting for prescription drugs, shall be 110 excluded. 111 (b) The agency contractor shall analyze the data submitted 112 under subsection (2) to compare prices among source countries 113 using a publicly available, reliable, and consistent exchange 114 rate source. The agency contractor shall establish the reference 115 price for each prescribed drug or product, which shall be the 116 lowest price, after adjusting for volume and difference in 117 national gross domestic product, identified in the source 118 countries. The agency contractor shall update the reference 119 prices annually, and may reevaluate and update a specific 120 reference price at any time based on a significant change 121 documented by supplemental pricing data submitted by a 122 manufacturer under paragraph (2)(b). 123 (c) The agency contractor shall provide the reference 124 prices no later than January 1 each year, and the agency shall 125 publish the reference prices online within 10 days of receipt. 126 Section 2. Subsection (3) is added to section 465.0244, 127 Florida Statutes, to read: 128 465.0244 Information disclosure and reference pricing.— 129 (3) A pharmacy shall charge a cash-paying patient an amount 130 no greater than the reference price for a prescribed drug or 131 product with a reference price established under s. 499.044. 132 This requirement applies to product reimbursement, and does not 133 apply to any dispensing fee. 134 Section 3. Subsections (3) and (4) are added to section 135 627.6044, Florida Statutes, to read: 136 627.6044 Use of a specific methodology for payment of 137 claims.— 138 (3) A health insurer, as defined by s. 627.4301, which 139 provides coverage for outpatient prescribed drugs and products 140 shall provide reimbursement for a covered prescribed drug for 141 which there is a reference price under s. 499.044 in an amount 142 no greater than the reference price. This subsection applies to 143 product reimbursement, and does not apply to any covered 144 dispensing or administering fee established under the terms of 145 the provider contract. 146 (a) Savings generated by this subsection must be used to 147 reduce policyholder cost sharing and premiums. Each health 148 insurer shall document anticipated savings and premium 149 reductions in rate filings beginning with the first rate filing 150 following the availability of reference prices under s. 499.044. 151 (b) Each health insurer shall assess the actuarial effect 152 of the reference pricing program in s. 499.044 for each insurer 153 product for each plan year. Beginning April 1 following the 154 first full plan year in which reference prices under s. 499.044 155 apply to prescription drug reimbursement, each health insurer 156 shall submit an annual report on the assessed effect to the 157 Office of Insurance Regulation or the Agency for Health Care 158 Administration, as applicable. 159 (c) The requirements of this subsection apply to 160 prescription drug coverage in the Medicaid program established 161 in chapter 409 to the extent a reference price established under 162 s. 499.044 generates greater savings for the program than that 163 provided by the state supplemental rebate program established 164 under s. 409.912. 165 (d) The requirements of this subsection apply to 166 prescription drug coverage in the state group insurance 167 established by part I of chapter 110. 168 (4) Beginning January 1, 2026, and annually thereafter, the 169 Office of Insurance Regulation and the Agency for Health Care 170 Administration shall submit a joint report to the Governor, the 171 President of the Senate, and the Speaker of the House of 172 Representatives detailing the impact of subsection (3) in the 173 preceding year, including savings realized compared to 174 prescription drug pricing in the United States not using this 175 pricing model, any problems encountered, barriers to access to 176 prescription drugs, domestic and foreign prescription drug 177 market response, monitoring and evaluating the impact on 178 prescription drug program or plan beneficiary access, quality of 179 care, and program costs. 180 Section 4. Subsection (6) is added to section 641.30, 181 Florida Statutes, to read: 182 641.30 Construction and relationship to other laws.— 183 (6) Every health maintenance organization must comply with 184 s. 627.6044(3). 185 Section 5. This act shall take effect July 1, 2024.