Illinois 2023-2024 Regular Session

Illinois House Bill HB1034 Compare Versions

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11 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB1034 Introduced , by Rep. Mary E. Flowers SYNOPSIS AS INTRODUCED: 410 ILCS 620/16.2 new Amends the Illinois Food, Drug and Cosmetic Act. Provides that the amendatory provisions apply to any manufacturer of a prescription drug that is purchased or reimbursed by specified parties. Provides that a manufacturer of a prescription drug with a wholesale acquisition cost of more than $40 for a course of therapy shall notify specified parties if the increase in the wholesale acquisition cost of the prescription drug is more than 10%, including the proposed increase and cumulative increase. Provides that the notice of price increase shall be provided in writing at least 60 days prior to the planned date of the increase. Provides that no later than 30 days after notification of a price increase or new prescription drug the manufacturer shall report specified additional information to specified parties. Provides that a manufacturer of a prescription drug shall provide written notice if the manufacturer is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds a specified threshold. Provides that failure to provide notice under the amendatory provisions shall result in a civil penalty of $10,000 per day for every day after the notification period that the manufacturer fails to report the information. Requires the Department of Public Health to conduct an annual public hearing on the aggregate trends in prescription drug pricing. Requires the Department to publish on its website a report detailing findings from the public hearing and a summary of details from reports provided under the amendatory provisions, except for information identified as a trade secret or exempted under the Freedom of Information Act. Provides that the amendatory provisions shall not restrict the legal ability of a pharmaceutical manufacturer to change prices as permitted under federal law. LRB103 04886 CPF 49896 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB1034 Introduced , by Rep. Mary E. Flowers SYNOPSIS AS INTRODUCED: 410 ILCS 620/16.2 new 410 ILCS 620/16.2 new Amends the Illinois Food, Drug and Cosmetic Act. Provides that the amendatory provisions apply to any manufacturer of a prescription drug that is purchased or reimbursed by specified parties. Provides that a manufacturer of a prescription drug with a wholesale acquisition cost of more than $40 for a course of therapy shall notify specified parties if the increase in the wholesale acquisition cost of the prescription drug is more than 10%, including the proposed increase and cumulative increase. Provides that the notice of price increase shall be provided in writing at least 60 days prior to the planned date of the increase. Provides that no later than 30 days after notification of a price increase or new prescription drug the manufacturer shall report specified additional information to specified parties. Provides that a manufacturer of a prescription drug shall provide written notice if the manufacturer is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds a specified threshold. Provides that failure to provide notice under the amendatory provisions shall result in a civil penalty of $10,000 per day for every day after the notification period that the manufacturer fails to report the information. Requires the Department of Public Health to conduct an annual public hearing on the aggregate trends in prescription drug pricing. Requires the Department to publish on its website a report detailing findings from the public hearing and a summary of details from reports provided under the amendatory provisions, except for information identified as a trade secret or exempted under the Freedom of Information Act. Provides that the amendatory provisions shall not restrict the legal ability of a pharmaceutical manufacturer to change prices as permitted under federal law. LRB103 04886 CPF 49896 b LRB103 04886 CPF 49896 b A BILL FOR
22 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB1034 Introduced , by Rep. Mary E. Flowers SYNOPSIS AS INTRODUCED:
33 410 ILCS 620/16.2 new 410 ILCS 620/16.2 new
44 410 ILCS 620/16.2 new
55 Amends the Illinois Food, Drug and Cosmetic Act. Provides that the amendatory provisions apply to any manufacturer of a prescription drug that is purchased or reimbursed by specified parties. Provides that a manufacturer of a prescription drug with a wholesale acquisition cost of more than $40 for a course of therapy shall notify specified parties if the increase in the wholesale acquisition cost of the prescription drug is more than 10%, including the proposed increase and cumulative increase. Provides that the notice of price increase shall be provided in writing at least 60 days prior to the planned date of the increase. Provides that no later than 30 days after notification of a price increase or new prescription drug the manufacturer shall report specified additional information to specified parties. Provides that a manufacturer of a prescription drug shall provide written notice if the manufacturer is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds a specified threshold. Provides that failure to provide notice under the amendatory provisions shall result in a civil penalty of $10,000 per day for every day after the notification period that the manufacturer fails to report the information. Requires the Department of Public Health to conduct an annual public hearing on the aggregate trends in prescription drug pricing. Requires the Department to publish on its website a report detailing findings from the public hearing and a summary of details from reports provided under the amendatory provisions, except for information identified as a trade secret or exempted under the Freedom of Information Act. Provides that the amendatory provisions shall not restrict the legal ability of a pharmaceutical manufacturer to change prices as permitted under federal law.
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1111 1 AN ACT concerning health.
1212 2 Be it enacted by the People of the State of Illinois,
1313 3 represented in the General Assembly:
1414 4 Section 5. The Illinois Food, Drug and Cosmetic Act is
1515 5 amended by adding Section 16.2 as follows:
1616 6 (410 ILCS 620/16.2 new)
1717 7 Sec. 16.2. Prescription drug price increases.
1818 8 (a) This Section shall apply to any manufacturer of a
1919 9 prescription drug that is purchased or reimbursed by any of
2020 10 the following:
2121 11 (1) A State purchaser, including, but not limited to,
2222 12 State retirement systems, the Department of Corrections,
2323 13 the Department of Healthcare and Family Services, the
2424 14 Department of Public Health, or any entity acting on
2525 15 behalf of a State purchaser.
2626 16 (2) A health insurer.
2727 17 (3) A health care service plan provider.
2828 18 (4) A pharmacy benefit manager.
2929 19 (b) A manufacturer of a prescription drug with a wholesale
3030 20 acquisition cost of more than $40 for a course of therapy shall
3131 21 notify each party described in subsection (a) if there is an
3232 22 increase in the wholesale acquisition cost of the prescription
3333 23 drug of more than 10%, including the proposed increase and
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3838 410 ILCS 620/16.2 new 410 ILCS 620/16.2 new
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4040 Amends the Illinois Food, Drug and Cosmetic Act. Provides that the amendatory provisions apply to any manufacturer of a prescription drug that is purchased or reimbursed by specified parties. Provides that a manufacturer of a prescription drug with a wholesale acquisition cost of more than $40 for a course of therapy shall notify specified parties if the increase in the wholesale acquisition cost of the prescription drug is more than 10%, including the proposed increase and cumulative increase. Provides that the notice of price increase shall be provided in writing at least 60 days prior to the planned date of the increase. Provides that no later than 30 days after notification of a price increase or new prescription drug the manufacturer shall report specified additional information to specified parties. Provides that a manufacturer of a prescription drug shall provide written notice if the manufacturer is introducing a new prescription drug to market at a wholesale acquisition cost that exceeds a specified threshold. Provides that failure to provide notice under the amendatory provisions shall result in a civil penalty of $10,000 per day for every day after the notification period that the manufacturer fails to report the information. Requires the Department of Public Health to conduct an annual public hearing on the aggregate trends in prescription drug pricing. Requires the Department to publish on its website a report detailing findings from the public hearing and a summary of details from reports provided under the amendatory provisions, except for information identified as a trade secret or exempted under the Freedom of Information Act. Provides that the amendatory provisions shall not restrict the legal ability of a pharmaceutical manufacturer to change prices as permitted under federal law.
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6868 1 cumulative increase that has occurred within the previous 2
6969 2 calendar years prior to the date of the proposed increase.
7070 3 For purposes of this subsection, "course of therapy" means
7171 4 either of the following:
7272 5 (1) The recommended daily dosage units of a
7373 6 prescription drug pursuant to its prescribing label as
7474 7 approved by the federal Food and Drug Administration for a
7575 8 normal course of treatment that is 30 days or more.
7676 9 (2) The recommended daily dosage units of a
7777 10 prescription drug pursuant to its prescribing label as
7878 11 approved by the federal Food and Drug Administration for a
7979 12 normal course of treatment that is less than 30 days.
8080 13 (c) The notice required under subsection (b) shall be
8181 14 provided in writing at least 60 days prior to the planned date
8282 15 of the increase in the wholesale acquisition cost.
8383 16 (d) No later than 30 days after providing notification of
8484 17 a price increase under subsection (b), a manufacturer shall
8585 18 report the following information to each party described in
8686 19 subsection (a):
8787 20 (1) The latest applicable wholesale acquisition cost.
8888 21 (2) The date of the latest previous increase in
8989 22 wholesale acquisition cost.
9090 23 (3) The per-unit dollar amount of the scheduled
9191 24 increase in wholesale acquisition cost.
9292 25 (4) A schedule of wholesale acquisition cost increases
9393 26 for the previous 5 years, where available, or for the
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104104 1 years since the drug has been approved by the federal Food
105105 2 and Drug Administration if that length of time is less
106106 3 than 5 years.
107107 4 (5) The date and price of acquisition, if the drug was
108108 5 not developed by the manufacturer.
109109 6 (6) A description of each financial and nonfinancial
110110 7 factor that contributes to the wholesale acquisition cost,
111111 8 including the following:
112112 9 (A) A percentage of the price attributable to each
113113 10 factor.
114114 11 (B) An explanation of the role of each factor in
115115 12 the price of the drug.
116116 13 (e) A manufacturer of a prescription drug shall provide
117117 14 written notice to each party described in subsection (a) if
118118 15 the manufacturer is introducing a new prescription drug to
119119 16 market at a wholesale acquisition cost that exceeds the
120120 17 threshold set for a specialty drug under the Medicare Part D
121121 18 program. This notice shall be provided no later than 30 days
122122 19 prior to the release of the drug on the commercial market.
123123 20 (f) No later than 30 days after providing the notification
124124 21 of a new prescription drug under subsection (e), a
125125 22 manufacturer shall report the following information to each
126126 23 party described in subsection (a):
127127 24 (1) The latest applicable wholesale acquisition cost.
128128 25 (2) The date of the latest previous increase in
129129 26 wholesale acquisition cost.
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140140 1 (3) The per-unit dollar amount of the scheduled
141141 2 increase in wholesale acquisition cost.
142142 3 (4) A schedule of wholesale acquisition costs
143143 4 increases for the previous 5 years, where available, or
144144 5 for the years since the drug has been approved by the
145145 6 federal Food and Drug Administration if that length of
146146 7 time is less than 5 years.
147147 8 (5) The date and price of acquisition, if the drug was
148148 9 not developed by the manufacturer.
149149 10 (6) A description of each financial and nonfinancial
150150 11 factor that contributes to the wholesale acquisition cost,
151151 12 including the following:
152152 13 (A) A percentage of the price attributable to each
153153 14 factor.
154154 15 (B) An explanation of the role of each factor in
155155 16 the price of the drug.
156156 17 (g) Failure to provide the information required under
157157 18 subsections (b), (d), (e), or (f) to each party described in
158158 19 subsection (a) shall result in a civil penalty of $10,000 per
159159 20 day for every day after the notification period that the
160160 21 manufacturer fails to provide the information.
161161 22 (h) The Department of Public Health shall conduct an
162162 23 annual public hearing on the aggregate trends in prescription
163163 24 drug pricing. The hearing shall provide for public discussion
164164 25 of overall price increases, emerging trends, decreases in drug
165165 26 spending, and the impact of prescription drug spending on
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176176 1 health care affordability and premiums.
177177 2 (i) The Department of Public Health shall publish on its
178178 3 website a report detailing findings from the public hearing
179179 4 held under subsection (h) and a summary of information
180180 5 provided under subsections (b), (d), (e), and (f).
181181 6 (j) The Department of Public Health may not post on its
182182 7 website any information described in subsections (d) or (f) of
183183 8 this Section that is identified as a trade secret under the
184184 9 Illinois Trade Secrets Act.
185185 10 (k) The Department of Public Health shall keep
186186 11 confidential all information provided to the Department that
187187 12 would qualify for an exemption under Section 7 of the Freedom
188188 13 of Information Act.
189189 14 (l) This Section shall not restrict the legal ability of a
190190 15 pharmaceutical manufacturer to change prices as permitted
191191 16 under federal law.
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