Florida 2024 Regular Session

Florida House Bill H1431 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1
2	2
3	3	HB 1431 2024
4	4
5	5
6	6
7	7	CODING: Words stricken are deletions; words underlined are additions.
8	8	hb1431-00
9	9	Page 1 of 8
10	10	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
11	11
12	12
13	13
14	14	A bill to be entitled 1
15	15	An act relating to international drug reference 2
16	16	pricing; creating s. 499.044, F.S.; providing 3
17	17	legislative policy; requiring permitholders for 4
18	18	prescription drug manufacturer permitholders to 5
19	19	annually report certain international price data to 6
20	20	the Agency for Health Care Administration; providing 7
21	21	for administrative enforcement via a specified fine 8
22	22	and permit suspension; requiring the agency to 9
23	23	contract with an entity to designate reference price 10
24	24	source countries and establish the reference prices 11
25	25	for prescription drugs based on certain criteria; 12
26	26	requiring the agency contractor to reevaluate the 13
27	27	designated reference prices source countries annually 14
28	28	and revised, as needed; requiring the agency 15
29	29	contractor to weigh the reference price benchmark 16
30	30	value of such countries in two or more tiers, using 17
31	31	specified criteria; providing applicability; defining 18
32	32	the term "real gross domestic product per capita"; 19
33	33	requiring the agency contractor to analyze specified 20
34	34	data to compare prices among source countries using a 21
35	35	specified exchange rate source; requiring the agency 22
36	36	contractor to establish the reference price for 23
37	37	prescribed drugs or products; requiring such price be 24
38	38	the lowest price after making certain adjustments; 25
39	39
40	40	HB 1431 2024
41	41
42	42
43	43
44	44	CODING: Words stricken are deletions; words underlined are additions.
45	45	hb1431-00
46	46	Page 2 of 8
47	47	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
48	48
49	49
50	50
51	51	requiring the agency contractor to update the 26
52	52	reference prices annually and permitting reevaluation 27
53	53	and updates at any time in certain circumstances; 28
54	54	requiring the agency contractor to provide the 29
55	55	reference prices by a specified date each year; 30
56	56	requiring the agency to publish the prices online 31
57	57	within a specified tim e; amending s. 465.0244, F.S.; 32
58	58	requiring pharmacies to charge no more than the 33
59	59	reference price for cash -paying patients; providing 34
60	60	applicability; amending s. 627.6044, F.S.; requiring 35
61	61	certain health insurers to provide reimbursement for 36
62	62	certain prescription drugs no higher than the 37
63	63	reference price; defining the term "health insurer"; 38
64	64	providing applicability; requiring health insurers to 39
65	65	use certain savings to offset certain payer costs; 40
66	66	requiring each health insurer to document anticipated 41
67	67	savings and premium reductions in rate filings 42
68	68	following the availability of reference prices; 43
69	69	requiring each health insurer to assess the actuarial 44
70	70	effect of the reference pricing program for each 45
71	71	insurer product for each plan year; requiring each 46
72	72	health insurer to submit an annual report on the 47
73	73	assessed effect of such program to the Office of 48
74	74	Insurance Regulation or the Agency for Health Care 49
75	75	Administration; providing applicability; requiring the 50
76	76
77	77	HB 1431 2024
78	78
79	79
80	80
81	81	CODING: Words stricken are deletions; words underlined are additions.
82	82	hb1431-00
83	83	Page 3 of 8
84	84	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
85	85
86	86
87	87
88	88	Office of Insurance Regulation and the Agency for 51
89	89	Health Care Administration to submit a joint report to 52
90	90	the Governor and the Legislature; amending s. 641.30, 53
91	91	F.S.; requiring every health maintenance organization 54
92	92	to comply with the provisions of a specified section; 55
93	93	providing an effective date. 56
94	94	57
95	95	Be It Enacted by the Legislatur e of the State of Florida: 58
96	96	59
97	97	Section 1. Section 499.044, Florida Statutes, is created 60
98	98	to read: 61
99	99	499.044 International Drug Reference Pricing. — 62
100	100	(1) It is the policy of the state that patients and third 63
101	101	party payers in the state should not pay more for prescription 64
102	102	drugs than those in international markets. 65
103	103	(2) Beginning October 1, 2025, each prescription drug 66
104	104	manufacturer permitholder and nonresident prescription drug 67
105	105	manufacturer permitholder shall annually report international 68
106	106	prescription drug pri ce data to the Agency for Health Care 69
107	107	Administration. 70
108	108	(a) Permitholders shall report the actual outpatient 71
109	109	payment or reimbursement amounts for each prescribed drug in 72
110	110	each reference price source country identified under this 73
111	111	subsection, including amount s paid by both third party payers 74
112	112	such as insurers and government benefit programs and by 75
113	113
114	114	HB 1431 2024
115	115
116	116
117	117
118	118	CODING: Words stricken are deletions; words underlined are additions.
119	119	hb1431-00
120	120	Page 4 of 8
121	121	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
122	122
123	123
124	124
125	125	individual consumers not using third party payers, net of 76
126	126	rebates and other forms of discounts. Permitholders may report 77
127	127	the average payment amounts for each drug for a reference price 78
128	128	source country, if weighted by utilization volume and fully 79
129	129	documented to the agency. 80
130	130	(b) Permitholders may provide supplemental pricing data at 81
131	131	any time during the year, based on a pricing in a reference 82
132	132	price source country. 83
133	133	(c) Permitholders shall report the data in a format 84
134	134	established by the agency in consultation with the contractor 85
135	135	established under this subsection. 86
136	136	(d) Failure to timely report required data shall result in 87
137	137	a fine of $10,000 a day for the first 30 days, and p ermit 88
138	138	suspension thereafter until compliance is achieved. 89
139	139	(3) The agency shall contract with an entity to designate 90
140	140	reference price source countries and analyze the data submitted 91
141	141	under subsection (2) to establish the reference price for each 92
142	142	prescribed drug or product. The agency contractor shall 93
143	143	reevaluate the designated reference price source countries 94
144	144	annually and revise, as needed. The agency contractor shall 95
145	145	weigh the reference price benchmark value of the selected 96
146	146	reference price source countries i n two or more tiers, using an 97
147	147	established index measuring the level of health care system 98
148	148	market orientation in each country. 99
149	149	(a) Reference price source countries shall include only 100
150	150
151	151	HB 1431 2024
152	152
153	153
154	154
155	155	CODING: Words stricken are deletions; words underlined are additions.
156	156	hb1431-00
157	157	Page 5 of 8
158	158	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
159	159
160	160
161	161
162	162	countries with a real gross domestic product per capita of at 101
163	163	least 40 percent of the United States gross domestic product per 102
164	164	capita, using international sales, volume, and pricing data for 103
165	165	each country. For the purposes of this subsection, "real gross 104
166	166	domestic product per capita" means a country's most recent 105
167	167	estimate based on purchasing power parity for that country 106
168	168	available in the most recent edition of the United States 107
169	169	Central Intelligence Agency World Factbook. Countries with 108
170	170	single-payer health systems, which include whole -market 109
171	171	government price-setting for prescripti on drugs, shall be 110
172	172	excluded. 111
173	173	(b) The agency contractor shall analyze the data submitted 112
174	174	under subsection (2) to compare prices among source countries 113
175	175	using a publicly available, reliable, and consistent exchange 114
176	176	rate source. The agency contractor shall e stablish the reference 115
177	177	price for each prescribed drug or product, which shall be the 116
178	178	lowest price, after adjusting for volume and difference in 117
179	179	national gross domestic product, identified in the source 118
180	180	countries. The agency contractor shall update the refe rence 119
181	181	prices annually, and may reevaluate and update a specific 120
182	182	reference price at any time based on a significant change 121
183	183	documented by supplemental pricing data submitted by a 122
184	184	manufacturer under paragraph (2)(b). 123
185	185	(c) The agency contractor shall provide the reference 124
186	186	prices no later than January 1 each year, and the agency shall 125
187	187
188	188	HB 1431 2024
189	189
190	190
191	191
192	192	CODING: Words stricken are deletions; words underlined are additions.
193	193	hb1431-00
194	194	Page 6 of 8
195	195	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
196	196
197	197
198	198
199	199	publish the reference prices online within 10 days of receipt. 126
200	200	Section 2. Subsection (3) is added to section 465.0244, 127
201	201	Florida Statutes, to read: 128
202	202	465.0244 Information disclosure and reference pricing .— 129
203	203	(3) A pharmacy shall charge a cash -paying patient an 130
204	204	amount no greater that the reference price for a prescribed drug 131
205	205	or product with a reference price established under s. 499.044. 132
206	206	This requirement applies to product reimbursement, and does not 133
207	207	apply to any dispensing fee. 134
208	208	Section 3. Subsections (3) and (4) are added to section 135
209	209	627.6044, Florida Statutes, to read: 136
210	210	627.6044 Use of a specific methodology for payment of 137
211	211	claims.— 138
212	212	(3) A health insurer that provides coverage for outpatient 139
213	213	prescribed drugs and products shall provide reimbursement for a 140
214	214	covered prescribed drug for which there is a reference price 141
215	215	under s. 499.044 in an amount no greater than the reference 142
216	216	price. As used in this sub section, the term "health insurer" 143
217	217	means an authorized insurer offering health insurance as defined 144
218	218	in s. 624.603, the Medicaid program as established in chapter 145
219	219	409 and as provided in paragraph (c), the State Group Insurance 146
220	220	Program as established in part I of chapter 110, or a health 147
221	221	maintenance organization as defined in s. 641.19(12). This 148
222	222	subsection applies to product reimbursement, and does not apply 149
223	223	to any covered dispensing or administering fee established under 150
224	224
225	225	HB 1431 2024
226	226
227	227
228	228
229	229	CODING: Words stricken are deletions; words underlined are additions.
230	230	hb1431-00
231	231	Page 7 of 8
232	232	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
233	233
234	234
235	235
236	236	the terms of the provider contract. 151
237	237	(a) Savings generated by this subsection must be used to 152
238	238	reduce policyholder cost sharing and premiums. Each health 153
239	239	insurer shall document anticipated savings and premium 154
240	240	reductions in rate filings beginning with the first rate filing 155
241	241	following the availa bility of reference prices under s. 499.044. 156
242	242	(b) Each health insurer shall assess the actuarial effect 157
243	243	of the reference pricing program in s. 499.044 for each insurer 158
244	244	product for each plan year. Beginning April 1 following the 159
245	245	first full plan year in whi ch reference prices under s. 499.044 160
246	246	apply to prescription drug reimbursement, each health insurer 161
247	247	shall submit an annual report on the assessed effect to the 162
248	248	Office of Insurance Regulation or the Agency for Health Care 163
249	249	Administration, as applicable. 164
250	250	(c) The requirements of this subsection apply to 165
251	251	prescription drug coverage in the Medicaid program established 166
252	252	in chapter 409 to the extent a reference price established under 167
253	253	s. 499.044 generates greater savings for the program than that 168
254	254	provided by the state supplemental rebate program established 169
255	255	under s. 409.912. 170
256	256	(4) Beginning January 1, 2026, and annually thereafter, 171
257	257	the Office of Insurance Regulation and the Agency for Health 172
258	258	Care Administration shall submit a joint report to the Governor, 173
259	259	the President of the Senate, and the Speaker of the House of 174
260	260	Representatives detailing the impact of subsection (3) in the 175
261	261
262	262	HB 1431 2024
263	263
264	264
265	265
266	266	CODING: Words stricken are deletions; words underlined are additions.
267	267	hb1431-00
268	268	Page 8 of 8
269	269	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
270	270
271	271
272	272
273	273	preceding year, including savings realized compared to 176
274	274	prescription drug pricing in the United States not using this 177
275	275	pricing model, any problems encountered, barriers to access to 178
276	276	prescription drugs, domestic and foreign prescription drug 179
277	277	market response, monitoring and evaluating the impact on 180
278	278	prescription drug program or plan beneficiary access, quality of 181
279	279	care, and program costs. 182
280	280	Section 4. Subsection (6) is added to section 641.30, 183
281	281	Florida Statutes, to read: 184
282	282	641.30 Construction and relationship to other laws. — 185
283	283	(6) Every health maintenance organization must comply with 186
284	284	s. 627.6044(3). 187
285	285	Section 5. This act shall take effect July 1, 2024. 188