HB 1431 2024
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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 international drug reference 2
pricing; creating s. 499.044, F.S.; providing 3
legislative policy; requiring permitholders for 4
prescription drug manufacturer permitholders to 5
annually report certain international price data to 6
the Agency for Health Care Administration; providing 7
for administrative enforcement via a specified fine 8
and permit suspension; requiring the agency to 9
contract with an entity to designate reference price 10
source countries and establish the reference prices 11
for prescription drugs based on certain criteria; 12
requiring the agency contractor to reevaluate the 13
designated reference prices source countries annually 14
and revised, as needed; requiring the agency 15
contractor to weigh the reference price benchmark 16
value of such countries in two or more tiers, using 17
specified criteria; providing applicability; defining 18
the term "real gross domestic product per capita"; 19
requiring the agency contractor to analyze specified 20
data to compare prices among source countries using a 21
specified exchange rate source; requiring the agency 22
contractor to establish the reference price for 23
prescribed drugs or products; requiring such price be 24
the lowest price after making certain adjustments; 25
HB 1431 2024
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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
requiring the agency contractor to update the 26
reference prices annually and permitting reevaluation 27
and updates at any time in certain circumstances; 28
requiring the agency contractor to provide the 29
reference prices by a specified date each year; 30
requiring the agency to publish the prices online 31
within a specified tim e; amending s. 465.0244, F.S.; 32
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; defining the term "health insurer"; 38
providing applicability; requiring health insurers to 39
use certain savings to offset certain payer costs; 40
requiring each health insurer to document anticipated 41
savings and premium reductions in rate filings 42
following the availability of reference prices; 43
requiring each health insurer to assess the actuarial 44
effect of the reference pricing program for each 45
insurer product for each plan year; requiring each 46
health insurer to submit an annual report on the 47
assessed effect of such program to the Office of 48
Insurance Regulation or the Agency for Health Care 49
Administration; providing applicability; requiring the 50
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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
Office of Insurance Regulation and the Agency for 51
Health Care Administration to submit a joint report to 52
the Governor and the Legislature; amending s. 641.30, 53
F.S.; requiring every health maintenance organization 54
to comply with the provisions of a specified section; 55
providing an effective date. 56
57
Be It Enacted by the Legislatur e of the State of Florida: 58
59
Section 1. Section 499.044, Florida Statutes, is created 60
to 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 pri ce 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 amount s paid by both third party payers 74
such as insurers and government benefit programs and by 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
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 p ermit 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 i n 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
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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
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 prescripti on 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 e stablish 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 refe rence 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
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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
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 130
amount no greater that the reference price for a prescribed drug 131
or 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 that provides coverage for outpatient 139
prescribed drugs and products shall provide reimbursement for a 140
covered prescribed drug for which there is a reference price 141
under s. 499.044 in an amount no greater than the reference 142
price. As used in this sub section, the term "health insurer" 143
means an authorized insurer offering health insurance as defined 144
in s. 624.603, the Medicaid program as established in chapter 145
409 and as provided in paragraph (c), the State Group Insurance 146
Program as established in part I of chapter 110, or a health 147
maintenance organization as defined in s. 641.19(12). This 148
subsection applies to product reimbursement, and does not apply 149
to any covered dispensing or administering fee established under 150
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the terms of the provider contract. 151
(a) Savings generated by this subsection must be used to 152
reduce policyholder cost sharing and premiums. Each health 153
insurer shall document anticipated savings and premium 154
reductions in rate filings beginning with the first rate filing 155
following the availa bility of reference prices under s. 499.044. 156
(b) Each health insurer shall assess the actuarial effect 157
of the reference pricing program in s. 499.044 for each insurer 158
product for each plan year. Beginning April 1 following the 159
first full plan year in whi ch reference prices under s. 499.044 160
apply to prescription drug reimbursement, each health insurer 161
shall submit an annual report on the assessed effect to the 162
Office of Insurance Regulation or the Agency for Health Care 163
Administration, as applicable. 164
(c) The requirements of this subsection apply to 165
prescription drug coverage in the Medicaid program established 166
in chapter 409 to the extent a reference price established under 167
s. 499.044 generates greater savings for the program than that 168
provided by the state supplemental rebate program established 169
under s. 409.912. 170
(4) Beginning January 1, 2026, and annually thereafter, 171
the Office of Insurance Regulation and the Agency for Health 172
Care Administration shall submit a joint report to the Governor, 173
the President of the Senate, and the Speaker of the House of 174
Representatives detailing the impact of subsection (3) in the 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
preceding year, including savings realized compared to 176
prescription drug pricing in the United States not using this 177
pricing model, any problems encountered, barriers to access to 178
prescription drugs, domestic and foreign prescription drug 179
market response, monitoring and evaluating the impact on 180
prescription drug program or plan beneficiary access, quality of 181
care, and program costs. 182
Section 4. Subsection (6) is added to section 641.30, 183
Florida Statutes, to read: 184
641.30 Construction and relationship to other laws. — 185
(6) Every health maintenance organization must comply with 186
s. 627.6044(3). 187
Section 5. This act shall take effect July 1, 2024. 188