Full Text of HB0053 101st General Assembly
HB0053ham001 101ST GENERAL ASSEMBLY | Rep. Mary E. Flowers Filed: 3/21/2019
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| 1 | | AMENDMENT TO HOUSE BILL 53
| 2 | | AMENDMENT NO. ______. Amend House Bill 53 by replacing | 3 | | everything after the enacting clause with the following:
| 4 | | "Section 5. The Illinois Food, Drug and Cosmetic Act is | 5 | | amended by adding Section 16.2 as follows: | 6 | | (410 ILCS 620/16.2 new) | 7 | | Sec. 16.2. Prescription drug price increases. | 8 | | (a) This Section shall apply to any manufacturer of a | 9 | | prescription drug that is purchased or reimbursed by any of the | 10 | | following: | 11 | | (1) A State purchaser, including, but not limited to, | 12 | | State retirement systems, the Department of Corrections, | 13 | | the Department of Healthcare and Family Services, the | 14 | | Department of Public Health, or any entity acting on behalf | 15 | | of a State purchaser. | 16 | | (2) A health insurer. |
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| 1 | | (3) A health care service plan provider. | 2 | | (4) A pharmacy benefit manager. | 3 | | (b) A manufacturer of a prescription drug with a wholesale | 4 | | acquisition cost of more than $40 for a course of therapy shall | 5 | | notify each party described in subsection (a) if there is an | 6 | | increase in the wholesale acquisition cost of the prescription | 7 | | drug of more than 10%, including the proposed increase and | 8 | | cumulative increase that has occurred within the previous 2 | 9 | | calendar years prior to the date of the proposed increase. | 10 | | For purposes of this subsection, "course of therapy" means | 11 | | either of the following: | 12 | | (1) The recommended daily dosage units of a | 13 | | prescription drug pursuant to its prescribing label as | 14 | | approved by the federal Food and Drug Administration for a | 15 | | normal course of treatment that is 30 days or more. | 16 | | (2) The recommended daily dosage units of a | 17 | | prescription drug pursuant to its prescribing label as | 18 | | approved by the federal Food and Drug Administration for a | 19 | | normal course of treatment that is less than 30 days. | 20 | | (c) The notice required under subsection (b) shall be | 21 | | provided in writing at least 60 days prior to the planned date | 22 | | of the increase in the wholesale acquisition cost. | 23 | | (d) No later than 30 days after providing notification of a | 24 | | price increase under subsection (b), a manufacturer shall | 25 | | report the following information to each party described in | 26 | | subsection (a): |
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| 1 | | (1) The latest applicable wholesale acquisition cost. | 2 | | (2) The date of the latest previous increase in | 3 | | wholesale acquisition cost. | 4 | | (3) The per-unit dollar amount of the scheduled | 5 | | increase in wholesale acquisition cost. | 6 | | (4) A schedule of wholesale acquisition cost increases | 7 | | for the previous 5 years, where available, or for the years | 8 | | since the drug has been approved by the federal Food and | 9 | | Drug Administration if that length of time is less than 5 | 10 | | years. | 11 | | (5) The date and price of acquisition, if the drug was | 12 | | not developed by the manufacturer. | 13 | | (6) A description of each financial and non-financial | 14 | | factor that contributes to the wholesale acquisition cost, | 15 | | including the following: | 16 | | (A) A percentage of the price attributable to each | 17 | | factor. | 18 | | (B) An explanation of the role of each factor in | 19 | | the price of the drug. | 20 | | (e) A manufacturer of a prescription drug shall provide | 21 | | written notice to each party described in subsection (a) if the | 22 | | manufacturer is introducing a new prescription drug to market | 23 | | at a wholesale acquisition cost that exceeds the threshold set | 24 | | for a specialty drug under the Medicare Part D program. This | 25 | | notice shall be provided no later than 30 days prior to the | 26 | | release of the drug on the commercial market. |
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| 1 | | (f) No later than 30 days after providing the notification | 2 | | of a new prescription drug under subsection (e), a manufacturer | 3 | | shall report the following information to each party described | 4 | | in subsection (a): | 5 | | (1) The latest applicable wholesale acquisition cost. | 6 | | (2) The date of the latest previous increase in | 7 | | wholesale acquisition cost. | 8 | | (3) The per-unit dollar amount of the scheduled | 9 | | increase in wholesale acquisition cost. | 10 | | (4) A schedule of wholesale acquisition costs | 11 | | increases for the previous 5 years, where available, or for | 12 | | the years since the drug has been approved by the federal | 13 | | Food and Drug Administration if that length of time is less | 14 | | than 5 years. | 15 | | (5) The date and price of acquisition, if the drug was | 16 | | not developed by the manufacturer. | 17 | | (6) A description of each financial and non-financial | 18 | | factor that contributes to the wholesale acquisition cost, | 19 | | including the following: | 20 | | (A) A percentage of the price attributable to each | 21 | | factor. | 22 | | (B) An explanation of the role of each factor in | 23 | | the price of the drug. | 24 | | (g) Failure to provide the information required under | 25 | | subsections (b), (d), (e), or (f) to each party described in | 26 | | subsection (a) shall result in a civil penalty of $10,000 per |
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| 1 | | day for every day after the notification period that the | 2 | | manufacturer fails to provide the information. | 3 | | (h) The Department of Public Health shall conduct an annual | 4 | | public hearing on the aggregate trends in prescription drug | 5 | | pricing. The hearing shall provide for public discussion of | 6 | | overall price increases, emerging trends, decreases in drug | 7 | | spending, and the impact of prescription drug spending on | 8 | | health care affordability and premiums. | 9 | | (i) The Department of Public Health shall publish on its | 10 | | website a report detailing findings from the public hearing | 11 | | held under subsection (h) and a summary of information provided | 12 | | under subsections (b), (d), (e), and (f). | 13 | | (j) The Department of Public Health may not post on its | 14 | | website any information described in subsections (d) or (f) of | 15 | | this Section that is identified as a trade secret under the | 16 | | Illinois Trade Secrets Act. | 17 | | (k) The Department of Public Health shall keep confidential | 18 | | all information provided to the Department that would qualify | 19 | | for an exemption under Section 7 of the Freedom of Information | 20 | | Act. | 21 | | (l) This Section shall not restrict the legal ability of a | 22 | | pharmaceutical manufacturer to change prices as permitted | 23 | | under federal law. ".
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