Old | New | Differences | |
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1 | - | Enrolled Copy S.B. 69 | |
1 | + | 03-03 22:38 4th Sub. (Pumpkin) S.B. 69 | |
2 | + | Evan J. Vickers proposes the following substitute bill: | |
2 | 3 | 1 | |
3 | 4 | Medication Amendments | |
4 | 5 | 2025 GENERAL SESSION | |
5 | 6 | STATE OF UTAH | |
6 | 7 | Chief Sponsor: Evan J. Vickers | |
7 | - | House Sponsor: | |
8 | + | House Sponsor: | |
8 | 9 | 2 | |
9 | 10 | ||
10 | 11 | 3 | |
11 | 12 | LONG TITLE | |
12 | 13 | 4 | |
13 | 14 | General Description: | |
14 | 15 | 5 | |
15 | - | This bill addresses | |
16 | + | This bill addresses participation in a federal drug discount program. | |
16 | 17 | 6 | |
17 | 18 | Highlighted Provisions: | |
18 | 19 | 7 | |
19 | 20 | This bill: | |
20 | 21 | 8 | |
21 | - | ▸ defines | |
22 | + | ▸ defines terms; | |
22 | 23 | 9 | |
23 | - | ▸ prohibits | |
24 | + | ▸ prohibits a pharmaceutical manufacturer from restricting, prohibiting, or otherwise | |
24 | 25 | 10 | |
25 | - | ||
26 | + | interfering with a 340B entity's ability to: | |
26 | 27 | 11 | |
28 | + | ● acquire a 340B drug; or | |
29 | + | 12 | |
30 | + | ● participate in the 340B drug discount program; | |
31 | + | 13 | |
27 | 32 | ▸ permits the Public Employees' Benefit and Insurance Program to adjust its business | |
28 | - | 12 | |
29 | - | practices to mitigate any resulting financial impacts. | |
30 | - | 13 | |
33 | + | 14 | |
34 | + | practices to mitigate any resulting financial impacts; | |
35 | + | 15 | |
36 | + | ▸ permits a manufacturer to request certain claim information from 340B entities; and | |
37 | + | 16 | |
38 | + | ▸ requires 340B entities to submit information to the Insurance Department. | |
39 | + | 17 | |
31 | 40 | Money Appropriated in this Bill: | |
32 | - | ||
41 | + | 18 | |
33 | 42 | None | |
34 | - | ||
43 | + | 19 | |
35 | 44 | Other Special Clauses: | |
36 | - | ||
45 | + | 20 | |
37 | 46 | None | |
38 | - | ||
47 | + | 21 | |
39 | 48 | Utah Code Sections Affected: | |
40 | - | ||
49 | + | 22 | |
41 | 50 | ENACTS: | |
42 | - | ||
51 | + | 23 | |
43 | 52 | 31A-46-311, Utah Code Annotated 1953 | |
44 | - | 20 | |
53 | + | 24 | |
54 | + | 31A-46-312, Utah Code Annotated 1953 | |
55 | + | 25 | |
45 | 56 | ||
46 | - | ||
57 | + | 26 | |
47 | 58 | Be it enacted by the Legislature of the state of Utah: | |
48 | - | ||
59 | + | 27 | |
49 | 60 | Section 1. Section 31A-46-311 is enacted to read: | |
50 | - | ||
61 | + | 28 | |
51 | 62 | 31A-46-311 . Prohibited actions with respect to the 340B drug discount program. | |
52 | - | 24 | |
63 | + | 4th Sub. S.B. 69 4th Sub. (Pumpkin) S.B. 69 03-03 22:38 | |
64 | + | 29 | |
53 | 65 | (1) As used in this section, "manufacturer" means a pharmaceutical manufacturer, including | |
54 | - | ||
66 | + | 30 | |
55 | 67 | an agent or affiliate of a pharmaceutical manufacturer. | |
56 | - | ||
68 | + | 31 | |
57 | 69 | (2) A manufacturer may not: | |
58 | - | ||
70 | + | 32 | |
59 | 71 | (a) directly or indirectly restrict or prohibit: | |
60 | - | ||
61 | - | (i) a pharmacy from contracting with a 340B entity, including by denying the | |
62 | - | ||
72 | + | 33 | |
73 | + | (i) a pharmacy from contracting with a 340B entity, including by denying the | |
74 | + | 34 | |
63 | 75 | pharmacy access to a drug that is manufactured by the manufacturer; | |
64 | - | ||
76 | + | 35 | |
65 | 77 | (ii) a 340B entity from contracting with a pharmacy, including by denying the 340B | |
66 | - | ||
78 | + | 36 | |
67 | 79 | entity access to a drug that is manufactured by the manufacturer; | |
68 | - | ||
80 | + | 37 | |
69 | 81 | (iii) the acquisition, dispensing, or delivery of a 340B drug to any location authorized | |
70 | - | ||
82 | + | 38 | |
71 | 83 | by a 340B entity to receive the drug, unless prohibited by federal law; or | |
72 | - | ||
84 | + | 39 | |
73 | 85 | (iv) a 340B entity from receiving 340B drug discount program pricing for a 340B | |
74 | - | ||
86 | + | 40 | |
75 | 87 | drug, including by imposing a time limitation on a 340B entity to replenish or | |
76 | - | 36 | |
77 | - | submit a claim for a 340B drug; | |
78 | - | 37 | |
79 | - | (b) directly or indirectly: | |
80 | - | 38 | |
81 | - | (i) require a 340B entity to purchase a 340B drug from a supplier if the manufacturer | |
82 | - | 39 | |
83 | - | would otherwise permit the 340B entity to purchase a drug that is not a 340B drug | |
84 | - | 40 | |
85 | - | from the supplier; or | |
86 | 88 | 41 | |
87 | - | ||
89 | + | submit a claim for a 340B drug; or | |
88 | 90 | 42 | |
89 | - | ||
91 | + | (b) interfere with: | |
90 | 92 | 43 | |
91 | - | ||
93 | + | (i) a contract between a pharmacy and a 340B entity; or | |
92 | 94 | 44 | |
93 | - | the | |
95 | + | (ii) the ability of a pharmacy and a 340B entity to enter into a contract. | |
94 | 96 | 45 | |
95 | - | ( | |
97 | + | (3) The Public Employees' Benefit and Insurance Program created in Section 49-20-103 | |
96 | 98 | 46 | |
97 | - | ||
99 | + | may adjust the program's business practices to mitigate any financial impacts resulting | |
98 | 100 | 47 | |
99 | - | ||
101 | + | from this section. | |
100 | 102 | 48 | |
101 | - | ( | |
103 | + | (4) Nothing in this section shall be construed to conflict with federal law. | |
102 | 104 | 49 | |
103 | - | ||
105 | + | Section 2. Section 31A-46-312 is enacted to read: | |
104 | 106 | 50 | |
105 | - | ||
107 | + | 31A-46-312 . Claim information sharing and use -- 340B entity public reporting. | |
106 | 108 | 51 | |
107 | - | ( | |
109 | + | (1) As used in this section: | |
108 | 110 | 52 | |
109 | - | ||
111 | + | (a) "Bad debt" means the amount of money charged by a 340B entity for providing | |
110 | 112 | 53 | |
113 | + | health care services to a patient for which the 340B entity does not receive payment. | |
114 | + | 54 | |
115 | + | (b) "Claim information" means information that is: | |
116 | + | 55 | |
117 | + | (i) described in Subsection (2); and | |
118 | + | 56 | |
119 | + | (ii) related to a claim for a 340B drug that is: | |
120 | + | 57 | |
121 | + | (A) dispensed by a contract pharmacy; and | |
122 | + | 58 | |
123 | + | (B) manufactured by a single pharmaceutical manufacturer. | |
124 | + | 59 | |
125 | + | (c) "Contract pharmacy" means a pharmacy contracting with an entity participating in | |
126 | + | 60 | |
127 | + | the 340B drug discount program to dispense drugs purchased through the 340B drug | |
128 | + | 61 | |
129 | + | discount program. | |
130 | + | 62 | |
131 | + | (d) "Financial assistance" means the cost incurred by a 340B entity for providing health | |
132 | + | - 2 - 03-03 22:38 4th Sub. (Pumpkin) S.B. 69 | |
133 | + | 63 | |
134 | + | care services to a patient at a reduced cost or no cost. | |
135 | + | 64 | |
136 | + | (e) "Uncompensated care" means the sum of a 340B entity's bad debt and financial | |
137 | + | 65 | |
138 | + | assistance. | |
139 | + | 66 | |
140 | + | (2) A pharmaceutical manufacturer may request from a 340B entity the following claim | |
141 | + | 67 | |
142 | + | information: | |
143 | + | 68 | |
144 | + | (a) prescription number; | |
145 | + | 69 | |
146 | + | (b) prescribed date; | |
147 | + | 70 | |
148 | + | (c) fill date; | |
149 | + | 71 | |
150 | + | (d) national drug code; | |
151 | + | 72 | |
152 | + | (e) quantity; | |
153 | + | 73 | |
154 | + | (f) pharmacy identification; | |
155 | + | 74 | |
156 | + | (g) prescriber identification number; and | |
157 | + | 75 | |
158 | + | (h) 340B covered entity identification. | |
159 | + | 76 | |
160 | + | (3) A 340B entity that receives a request from a pharmaceutical manufacturer as described | |
161 | + | 77 | |
162 | + | in Subsection (2) shall provide to the pharmaceutical manufacturer the requested claim | |
163 | + | 78 | |
164 | + | information. | |
165 | + | 79 | |
166 | + | (4) A pharmaceutical manufacturer may only use claim information received under this | |
167 | + | 80 | |
168 | + | section to identify a rebate for an insurer or a third party administrator that is ineligible | |
169 | + | 81 | |
170 | + | for payment under the pharmaceutical manufacturer's policy. | |
171 | + | 82 | |
172 | + | (5)(a) Beginning on July 1, 2026, a 340B entity shall annually provide, on or before the | |
173 | + | 83 | |
174 | + | first day of the month after the 340B entity files the 340B entity's Medicare cost | |
175 | + | 84 | |
176 | + | report, the following to the department in a form and manner determined by the | |
177 | + | 85 | |
178 | + | department: | |
179 | + | 86 | |
180 | + | (i) the name of the 340B entity; | |
181 | + | 87 | |
182 | + | (ii) a copy of the 340B entity's annual 340B program recertification; | |
183 | + | 88 | |
184 | + | (iii) if the 340B entity is required to conduct a community health needs assessment | |
185 | + | 89 | |
186 | + | under Section 501(r)(3)(A), Internal Revenue Code, a copy of the 340B entity's | |
187 | + | 90 | |
188 | + | most recent community health needs assessment; | |
189 | + | 91 | |
190 | + | (iv) a statement that the 340B entity is in compliance with the 340B drug discount | |
191 | + | 92 | |
192 | + | program; | |
193 | + | 93 | |
194 | + | (v) the total number of contract pharmacies with which the 340B entity contracts; | |
195 | + | 94 | |
196 | + | (vi) the total number of contract pharmacies located out-of-state and the states in | |
197 | + | 95 | |
198 | + | which out-of-state contract pharmacies are located; and | |
199 | + | 96 | |
200 | + | (vii) for the prior year: | |
201 | + | - 3 - 4th Sub. (Pumpkin) S.B. 69 03-03 22:38 | |
202 | + | 97 | |
203 | + | (A) a description of the impact of the 340B drug discount program on the patients | |
204 | + | 98 | |
205 | + | and community served by the 340B entity; | |
206 | + | 99 | |
207 | + | (B) the total operating costs of the 340B entity; | |
208 | + | 100 | |
209 | + | (C) the total uncompensated care provided by the 340B entity; and | |
210 | + | 101 | |
211 | + | (D) the total number of prescriptions and the percentage of the 340B entity's | |
212 | + | 102 | |
213 | + | prescriptions filled at contract pharmacies. | |
214 | + | 103 | |
215 | + | (b) An officer of the 340B entity shall certify the completeness and accuracy of the | |
216 | + | 104 | |
217 | + | information submitted in accordance with Subsection (5)(a). | |
218 | + | 105 | |
219 | + | (c)(i) The department shall use the information described in Subsection (5)(a) to | |
220 | + | 106 | |
221 | + | prepare a report detailing aggregate information received from a 340B entity. | |
222 | + | 107 | |
223 | + | (ii) The department shall submit the report described in Subsection (5)(c)(i) to the | |
224 | + | 108 | |
225 | + | Health and Human Services Interim Committee on or before July 1, 2027. | |
226 | + | 109 | |
227 | + | (iii) The department shall post the report described in Subsection (5)(c)(ii) on a | |
228 | + | 110 | |
229 | + | publicly accessible website. | |
230 | + | 111 | |
231 | + | (6) Nothing in this section shall be construed to conflict with federal law. | |
232 | + | 112 | |
233 | + | Section 3. Effective Date. | |
234 | + | 113 | |
111 | 235 | This bill takes effect on May 7, 2025. | |
112 | - | - | |
236 | + | - 4 - |