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.