Full Text of HB0156 101st General Assembly
HB0156eng 101ST GENERAL ASSEMBLY |
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| 1 | | AN ACT concerning regulation.
| 2 | | Be it enacted by the People of the State of Illinois,
| 3 | | represented in the General Assembly:
| 4 | | Section 1. Short title. This Act may be cited as the | 5 | | Prescription Drug Pricing Transparency Act. | 6 | | Section 5. Definitions. In this Act: | 7 | | "Department" means the Department of Public Health. | 8 | | "Manufacturer" means any entity that is engaged in the | 9 | | production, preparation, propagation, compounding, conversion, | 10 | | or processing of prescription drugs, whether directly or | 11 | | indirectly by extraction from substances of natural origin, | 12 | | independently by means of chemical synthesis, or by a | 13 | | combination of extraction and chemical synthesis, or any entity | 14 | | engaged in the packaging, repackaging, labeling, relabeling, | 15 | | or distribution of prescription drugs. "Manufacturer" does not | 16 | | include a wholesale distributor of prescription drugs, a | 17 | | retailer, or a pharmacist licensed under the Pharmacy Practice | 18 | | Act. | 19 | | "Prescription drug" means a drug as defined in 21 U.S.C. | 20 | | 321. | 21 | | Section 10. Disclosures to the Department. | 22 | | (a) A health insurer shall disclose to the Department: |
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| 1 | | (1) for all covered prescription drugs, including | 2 | | generic drugs, brand-name drugs excluding specialty drugs, | 3 | | and specialty drugs dispensed at a pharmacy, network | 4 | | pharmacy, or mail-order pharmacy for outpatient use: | 5 | | (A) the percentage of the premium rate | 6 | | attributable to prescription drug costs for the prior | 7 | | year for each category of prescription drugs; | 8 | | (B) the year-over-year increase or decrease, | 9 | | expressed as a percentage, in per-member, per-month | 10 | | total health plan spending on each category of | 11 | | prescription drugs; and | 12 | | (C) the year-over-year increase or decrease in | 13 | | per-member, per-month costs for prescription drugs | 14 | | compared to other components of the premium rate; and | 15 | | (2) the specialty tier formulary list. | 16 | | (b) The health insurer shall provide, if available, the | 17 | | percentage of the premium rate attributable to prescription | 18 | | drugs administered by a health care provider in an outpatient | 19 | | setting that are part of the medical benefit as separate from | 20 | | the pharmacy benefit. | 21 | | (c) The health insurer shall include information on its use | 22 | | of a pharmacy benefit manager, if any, including which | 23 | | components of the prescription drug coverage described in | 24 | | subsections (a) and (b) are managed by the pharmacy benefit | 25 | | manager, as well as the name of the pharmacy benefit manager or | 26 | | pharmacy benefit managers used. |
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| 1 | | Section 15. Impact of prescription drug costs on health | 2 | | insurance premiums; report. | 3 | | (a) Each health insurer with more than 1,000 covered lives | 4 | | in this State for major medical health insurance shall report | 5 | | to the Department for all covered prescription drugs, including | 6 | | generic drugs, brand-name drugs, and specialty drugs, provided | 7 | | in an outpatient setting or sold in a retail setting: | 8 | | (1) the 25 most frequently prescribed drugs and the | 9 | | average wholesale price for each drug; | 10 | | (2) the 25 most costly drugs by total plan spending and | 11 | | the average wholesale price for each drug; and | 12 | | (3) the 25 drugs with the highest year-over-year price | 13 | | increases and the average wholesale price for each drug. | 14 | | (b) A health insurer shall not be required to provide to | 15 | | the Department the actual price paid, net of rebates, for any | 16 | | prescription drug. | 17 | | (c) The Department shall compile the information reported | 18 | | pursuant to subsection (a) into a consumer-friendly report that | 19 | | demonstrates the overall impact of drug costs on health | 20 | | insurance premiums. The data in the report shall be aggregated | 21 | | and shall not reveal information specific to a particular | 22 | | health benefit plan. | 23 | | (d) The Department shall publish the report required | 24 | | pursuant to subsection (a) on its website on or before January | 25 | | 1 of each year. |
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| 1 | | Section 20. Prescription drug cost transparency. | 2 | | (a) The Department shall create annually a list of 10 | 3 | | prescription drugs on which the State spends significant health | 4 | | care dollars and for which the wholesale acquisition cost has | 5 | | increased by 50% or more over the past 5 years or by 15% or more | 6 | | during the previous calendar year, creating a substantial | 7 | | public interest in understanding the development of the drugs' | 8 | | pricing. The list shall include at least one generic drug and | 9 | | one brand-name drug and shall indicate each of the drugs on the | 10 | | list that the Department considers to be specialty drugs. The | 11 | | Department shall include the percentage of the wholesale | 12 | | acquisition cost increase for each drug on the list; rank the | 13 | | drugs on the list from those with the largest increase in | 14 | | wholesale acquisition cost to those with the smallest increase; | 15 | | indicate whether each drug was included on the list based on | 16 | | its cost increase over the past 5 years or during the previous | 17 | | calendar year, or both; and provide the State's total | 18 | | expenditure for each drug on the list during the most recent | 19 | | calendar year. | 20 | | (b) The Department shall create annually a list of 10 | 21 | | prescription drugs on which the State spends significant health | 22 | | care dollars and for which the cost to the State, net of | 23 | | rebates and other price concessions, has increased by 50% or | 24 | | more over the past 5 years or by 15% or more during the | 25 | | previous calendar year, creating a substantial public interest |
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| 1 | | in understanding the development of the drugs' pricing. The | 2 | | list shall include at least one generic drug and one brand-name | 3 | | drug and shall indicate each of the drugs on the list that the | 4 | | Department considers to be specialty drugs. The Department | 5 | | shall rank the drugs on the list from those with the greatest | 6 | | increase in net cost to those with the smallest increase and | 7 | | indicate whether each drug was included on the list based on | 8 | | its cost increase over the past 5 years or during the previous | 9 | | calendar year, or both. | 10 | | (c) Each health insurer with more than 5,000 covered lives | 11 | | in this State for major medical health insurance shall create | 12 | | annually a list of 10 prescription drugs on which its health | 13 | | insurance plans spend significant amounts of their premium | 14 | | dollars and for which the cost to the plans, net of rebates and | 15 | | other price concessions, has increased by 50% or more over the | 16 | | past 5 years or by 15% or more during the previous calendar | 17 | | year, or both, creating a substantial public interest in | 18 | | understanding the development of the drugs' pricing. The list | 19 | | shall include at least one generic drug and one brand-name drug | 20 | | and shall indicate each of the drugs on the list that the | 21 | | health insurer considers to be specialty drugs. The health | 22 | | insurer shall rank the drugs on the list from those with the | 23 | | greatest increase in net cost to those with the smallest | 24 | | increase and indicate whether each drug was included on the | 25 | | list based on its cost increase over the past 5 years or during | 26 | | the previous calendar year, or both. |
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| 1 | | (d) Each health insurer creating a list pursuant to | 2 | | subsection (c) shall provide to the Office of the Attorney | 3 | | General the percentage by which the net cost to its plans | 4 | | increased over the applicable period or periods for each drug | 5 | | on the list, as well as the health insurer's total expenditure, | 6 | | net of rebates and other price concessions, for each drug on | 7 | | the list during the most recent calendar year. Information | 8 | | provided to the Office of the Attorney General pursuant to this | 9 | | subsection is exempt from public inspection and copying under | 10 | | the Freedom of Information Act and shall not be released. | 11 | | (e) The Department and the health insurers shall provide to | 12 | | the Office of the Attorney General the lists of prescription | 13 | | drugs developed pursuant to subsections (a), (b), and (c) | 14 | | annually on or before June 1. The Office of the Attorney | 15 | | General shall make all of the information available to the | 16 | | public on its website. | 17 | | (f) Of the prescription drugs listed by the Department and | 18 | | the health insurers pursuant to subsections (a), (b), and (c), | 19 | | the Office of the Attorney General shall: | 20 | | (1) of the drugs appearing on more than one payer's | 21 | | list, identify the top 15 drugs on which the greatest | 22 | | amount of money was spent across all payers during the | 23 | | previous calendar year, to the extent information is | 24 | | available; and | 25 | | (2) if fewer than 15 drugs appear on more than one | 26 | | payer's list, rank the remaining drugs based on the amount |
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| 1 | | of money spent by any one payer during the previous | 2 | | calendar year, in descending order, and select as many of | 3 | | the drugs at the top of the list as necessary to reach a | 4 | | total of 15 drugs. | 5 | | (g) For the 15 drugs identified by the Office of the | 6 | | Attorney General pursuant to subsection (f), the Office of the | 7 | | Attorney General shall require the manufacturer of each such | 8 | | drug to provide all of the following: | 9 | | (1) justification for the increase in the net cost of | 10 | | the drug to the Department, to one or more health insurers, | 11 | | or both, which shall be provided to the Office of the | 12 | | Attorney General in a format that the Office of the | 13 | | Attorney General determines to be understandable and | 14 | | appropriate and shall be provided in accordance with a | 15 | | timeline specified by the Office of the Attorney General; | 16 | | the manufacturer shall submit to the Office of the Attorney | 17 | | General all relevant information and supporting | 18 | | documentation necessary to justify the manufacturer's net | 19 | | cost increase to the Department, to one or more health | 20 | | insurers, or both during the identified period of time, | 21 | | including: | 22 | | (A) each factor that specifically caused the net | 23 | | cost increase to the Department, to one or more health | 24 | | insurers, or both during the specified period of time; | 25 | | (B) the percentage of the total cost increase | 26 | | attributable to each factor; and |
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| 1 | | (C) an explanation of the role of each factor in | 2 | | contributing to the cost increase; and | 3 | | (2) a separate version of the information submitted | 4 | | pursuant to subparagraph (A) of paragraph (1), which shall | 5 | | be made available to the public by the Office of the | 6 | | Attorney General pursuant to subsection (i); if the | 7 | | manufacturer believes it necessary to redact certain | 8 | | information in the public version as proprietary or | 9 | | confidential, the manufacturer shall provide an | 10 | | explanation for each such redaction to the Office of the | 11 | | Attorney General; the information, format, and any | 12 | | redactions shall be subject to approval by the Office of | 13 | | the Attorney General; and | 14 | | (3) additional information in response to all requests | 15 | | for such information by the Office of the Attorney General. | 16 | | (h) Nothing in this Section shall be construed to restrict | 17 | | the legal ability of a prescription drug manufacturer to change | 18 | | prices to the extent permitted under federal law. | 19 | | (i) The Attorney General shall provide a report to the | 20 | | General Assembly on or before December 1 of each year based on | 21 | | the information received from manufacturers pursuant to this | 22 | | Section. The report to the General Assembly shall be filed with | 23 | | the Clerk of the House of Representatives and the Secretary of | 24 | | the Senate in electronic form only, in the manner that the | 25 | | Clerk and the Secretary shall direct. The Attorney General | 26 | | shall post the report and the public version of each |
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| 1 | | manufacturer's information submitted pursuant to paragraph (2) | 2 | | of subsection (g) on the Office of the Attorney General's | 3 | | website. | 4 | | (j) The Department shall post on its website the report | 5 | | prepared by the Attorney General pursuant to subsection (i) and | 6 | | the public version of each manufacturer's information | 7 | | submitted pursuant to paragraph (2) of subsection (g) and may | 8 | | inform the public of the availability of the report and the | 9 | | manufacturers' justification information. | 10 | | (k) Information provided to the Office of the Attorney | 11 | | General pursuant to subsection (g) is exempt from public | 12 | | inspection and copying under the Freedom of Information Act and | 13 | | shall not be released in a manner that allows for the | 14 | | identification of an individual drug or manufacturer or that is | 15 | | likely to compromise the financial, competitive, or | 16 | | proprietary nature of the information, except for the | 17 | | information prepared for release to the public pursuant to | 18 | | paragraph (2) of subsection (g). | 19 | | (l) The Attorney General may bring an action in the circuit | 20 | | court of Sangamon County for injunctive relief, costs, and | 21 | | attorney's fees and to impose on a manufacturer that fails to | 22 | | provide any of the information required by subsections (f) and | 23 | | (g), in the format requested by the Office of the Attorney | 24 | | General and in accordance with the timeline specified by the | 25 | | Office of the Attorney General, a civil penalty of not more | 26 | | than $10,000 per violation. Each unlawful failure to provide |
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| 1 | | information shall constitute a separate violation. | 2 | | Section 25. Notice of introduction of new high-cost | 3 | | prescription drugs.
| 4 | | (a) A manufacturer shall notify the Office of the Attorney | 5 | | General in writing if it is introducing a new prescription drug | 6 | | to market at a wholesale acquisition cost that exceeds the | 7 | | threshold set for a specialty drug under the Medicare Part D | 8 | | program. The manufacturer shall provide the written notice | 9 | | within 3 calendar days following the release of the drug in the | 10 | | commercial market. A manufacturer may make the notification | 11 | | pending approval by the United States Food and Drug | 12 | | Administration if commercial availability is expected within 3 | 13 | | calendar days following the approval. | 14 | | (b) Not later than 30 calendar days following notification | 15 | | pursuant to subsection (a), the manufacturer shall provide all | 16 | | of the following information to the Office of the Attorney | 17 | | General in a format that the Office of the Attorney General | 18 | | prescribes: | 19 | | (1) a description of the marketing and pricing plans | 20 | | used in the launch of the new drug in the United States and | 21 | | internationally; | 22 | | (2) the estimated volume of patients who may be | 23 | | prescribed the drug; | 24 | | (3) whether the drug was granted breakthrough therapy | 25 | | designation or priority review by the United States Food |
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| 1 | | and Drug Administration prior to final approval; and | 2 | | (4) the date and price of acquisition if the drug was | 3 | | not developed by the manufacturer. | 4 | | (c) The manufacturer may limit the information reported | 5 | | pursuant to subsection (b) to that which is otherwise in the | 6 | | public domain or publicly available. | 7 | | (d) The Office of the Attorney General shall publish on its | 8 | | website at least quarterly the information reported to it | 9 | | pursuant to this Section. The information shall be published in | 10 | | a manner that identifies the information that is disclosed on a | 11 | | per-drug basis and shall not be aggregated in a manner that | 12 | | would not allow identification of the drug. | 13 | | (e) The Attorney General may bring an action in the circuit | 14 | | court of Sangamon County for injunctive relief, costs, and | 15 | | attorney's fees and to impose on a manufacturer that fails to | 16 | | provide the information required by subsection (b) a civil | 17 | | penalty of not more than $1,000 per day for every day after the | 18 | | notification period described in subsection (a) that the | 19 | | required information is not reported. | 20 | | Section 900. The Freedom of Information Act is amended by | 21 | | changing Section 7.5 as follows: | 22 | | (5 ILCS 140/7.5) | 23 | | Sec. 7.5. Statutory exemptions. To the extent provided for | 24 | | by the statutes referenced below, the following shall be exempt |
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| 1 | | from inspection and copying: | 2 | | (a) All information determined to be confidential | 3 | | under Section 4002 of the Technology Advancement and | 4 | | Development Act. | 5 | | (b) Library circulation and order records identifying | 6 | | library users with specific materials under the Library | 7 | | Records Confidentiality Act. | 8 | | (c) Applications, related documents, and medical | 9 | | records received by the Experimental Organ Transplantation | 10 | | Procedures Board and any and all documents or other records | 11 | | prepared by the Experimental Organ Transplantation | 12 | | Procedures Board or its staff relating to applications it | 13 | | has received. | 14 | | (d) Information and records held by the Department of | 15 | | Public Health and its authorized representatives relating | 16 | | to known or suspected cases of sexually transmissible | 17 | | disease or any information the disclosure of which is | 18 | | restricted under the Illinois Sexually Transmissible | 19 | | Disease Control Act. | 20 | | (e) Information the disclosure of which is exempted | 21 | | under Section 30 of the Radon Industry Licensing Act. | 22 | | (f) Firm performance evaluations under Section 55 of | 23 | | the Architectural, Engineering, and Land Surveying | 24 | | Qualifications Based Selection Act. | 25 | | (g) Information the disclosure of which is restricted | 26 | | and exempted under Section 50 of the Illinois Prepaid |
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| 1 | | Tuition Act. | 2 | | (h) Information the disclosure of which is exempted | 3 | | under the State Officials and Employees Ethics Act, and | 4 | | records of any lawfully created State or local inspector | 5 | | general's office that would be exempt if created or | 6 | | obtained by an Executive Inspector General's office under | 7 | | that Act. | 8 | | (i) Information contained in a local emergency energy | 9 | | plan submitted to a municipality in accordance with a local | 10 | | emergency energy plan ordinance that is adopted under | 11 | | Section 11-21.5-5 of the Illinois Municipal Code. | 12 | | (j) Information and data concerning the distribution | 13 | | of surcharge moneys collected and remitted by carriers | 14 | | under the Emergency Telephone System Act. | 15 | | (k) Law enforcement officer identification information | 16 | | or driver identification information compiled by a law | 17 | | enforcement agency or the Department of Transportation | 18 | | under Section 11-212 of the Illinois Vehicle Code. | 19 | | (l) Records and information provided to a residential | 20 | | health care facility resident sexual assault and death | 21 | | review team or the Executive Council under the Abuse | 22 | | Prevention Review Team Act. | 23 | | (m) Information provided to the predatory lending | 24 | | database created pursuant to Article 3 of the Residential | 25 | | Real Property Disclosure Act, except to the extent | 26 | | authorized under that Article. |
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| 1 | | (n) Defense budgets and petitions for certification of | 2 | | compensation and expenses for court appointed trial | 3 | | counsel as provided under Sections 10 and 15 of the Capital | 4 | | Crimes Litigation Act. This subsection (n) shall apply | 5 | | until the conclusion of the trial of the case, even if the | 6 | | prosecution chooses not to pursue the death penalty prior | 7 | | to trial or sentencing. | 8 | | (o) Information that is prohibited from being | 9 | | disclosed under Section 4 of the Illinois Health and | 10 | | Hazardous Substances Registry Act. | 11 | | (p) Security portions of system safety program plans, | 12 | | investigation reports, surveys, schedules, lists, data, or | 13 | | information compiled, collected, or prepared by or for the | 14 | | Regional Transportation Authority under Section 2.11 of | 15 | | the Regional Transportation Authority Act or the St. Clair | 16 | | County Transit District under the Bi-State Transit Safety | 17 | | Act. | 18 | | (q) Information prohibited from being disclosed by the | 19 | | Personnel Record Records Review Act. | 20 | | (r) Information prohibited from being disclosed by the | 21 | | Illinois School Student Records Act. | 22 | | (s) Information the disclosure of which is restricted | 23 | | under Section 5-108 of the Public Utilities Act.
| 24 | | (t) All identified or deidentified health information | 25 | | in the form of health data or medical records contained in, | 26 | | stored in, submitted to, transferred by, or released from |
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| 1 | | the Illinois Health Information Exchange, and identified | 2 | | or deidentified health information in the form of health | 3 | | data and medical records of the Illinois Health Information | 4 | | Exchange in the possession of the Illinois Health | 5 | | Information Exchange Authority due to its administration | 6 | | of the Illinois Health Information Exchange. The terms | 7 | | "identified" and "deidentified" shall be given the same | 8 | | meaning as in the Health Insurance Portability and | 9 | | Accountability Act of 1996, Public Law 104-191, or any | 10 | | subsequent amendments thereto, and any regulations | 11 | | promulgated thereunder. | 12 | | (u) Records and information provided to an independent | 13 | | team of experts under the Developmental Disability and | 14 | | Mental Health Safety Act (also known as Brian's Law ) . | 15 | | (v) Names and information of people who have applied | 16 | | for or received Firearm Owner's Identification Cards under | 17 | | the Firearm Owners Identification Card Act or applied for | 18 | | or received a concealed carry license under the Firearm | 19 | | Concealed Carry Act, unless otherwise authorized by the | 20 | | Firearm Concealed Carry Act; and databases under the | 21 | | Firearm Concealed Carry Act, records of the Concealed Carry | 22 | | Licensing Review Board under the Firearm Concealed Carry | 23 | | Act, and law enforcement agency objections under the | 24 | | Firearm Concealed Carry Act. | 25 | | (w) Personally identifiable information which is | 26 | | exempted from disclosure under subsection (g) of Section |
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| 1 | | 19.1 of the Toll Highway Act. | 2 | | (x) Information which is exempted from disclosure | 3 | | under Section 5-1014.3 of the Counties Code or Section | 4 | | 8-11-21 of the Illinois Municipal Code. | 5 | | (y) Confidential information under the Adult | 6 | | Protective Services Act and its predecessor enabling | 7 | | statute, the Elder Abuse and Neglect Act, including | 8 | | information about the identity and administrative finding | 9 | | against any caregiver of a verified and substantiated | 10 | | decision of abuse, neglect, or financial exploitation of an | 11 | | eligible adult maintained in the Registry established | 12 | | under Section 7.5 of the Adult Protective Services Act. | 13 | | (z) Records and information provided to a fatality | 14 | | review team or the Illinois Fatality Review Team Advisory | 15 | | Council under Section 15 of the Adult Protective Services | 16 | | Act. | 17 | | (aa) Information which is exempted from disclosure | 18 | | under Section 2.37 of the Wildlife Code. | 19 | | (bb) Information which is or was prohibited from | 20 | | disclosure by the Juvenile Court Act of 1987. | 21 | | (cc) Recordings made under the Law Enforcement | 22 | | Officer-Worn Body Camera Act, except to the extent | 23 | | authorized under that Act. | 24 | | (dd) Information that is prohibited from being | 25 | | disclosed under Section 45 of the Condominium and Common | 26 | | Interest Community Ombudsperson Act. |
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| 1 | | (ee) Information that is exempted from disclosure | 2 | | under Section 30.1 of the Pharmacy Practice Act. | 3 | | (ff) Information that is exempted from disclosure | 4 | | under the Revised Uniform Unclaimed Property Act. | 5 | | (gg) Information that is prohibited from being | 6 | | disclosed under Section 7-603.5 of the Illinois Vehicle | 7 | | Code. | 8 | | (hh) Records that are exempt from disclosure under | 9 | | Section 1A-16.7 of the Election Code. | 10 | | (ii) Information which is exempted from disclosure | 11 | | under Section 2505-800 of the Department of Revenue Law of | 12 | | the Civil Administrative Code of Illinois. | 13 | | (jj) Information and reports that are required to be | 14 | | submitted to the Department of Labor by registering day and | 15 | | temporary labor service agencies but are exempt from | 16 | | disclosure under subsection (a-1) of Section 45 of the Day | 17 | | and Temporary Labor Services Act. | 18 | | (kk) Information prohibited from disclosure under the | 19 | | Seizure and Forfeiture Reporting Act. | 20 | | (ll) Information the disclosure of which is restricted | 21 | | and exempted under Section 5-30.8 of the Illinois Public | 22 | | Aid Code. | 23 | | (mm) (ll) Records that are exempt from disclosure under | 24 | | Section 4.2 of the Crime Victims Compensation Act. | 25 | | (nn) (ll) Information that is exempt from disclosure | 26 | | under Section 70 of the Higher Education Student Assistance |
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| 1 | | Act. | 2 | | (oo) Information provided to the Office of the Attorney | 3 | | General under subsections (d) and (g) of Section 20 of the | 4 | | Prescription Drug Pricing Transparency Act, except for the | 5 | | information prepared for release to the public pursuant to | 6 | | paragraph (2) of subsection (g) of Section 20 of the | 7 | | Prescription Drug Pricing Transparency Act. | 8 | | (Source: P.A. 99-78, eff. 7-20-15; 99-298, eff. 8-6-15; 99-352, | 9 | | eff. 1-1-16; 99-642, eff. 7-28-16; 99-776, eff. 8-12-16; | 10 | | 99-863, eff. 8-19-16; 100-20, eff. 7-1-17; 100-22, eff. 1-1-18; | 11 | | 100-201, eff. 8-18-17; 100-373, eff. 1-1-18; 100-464, eff. | 12 | | 8-28-17; 100-465, eff. 8-31-17; 100-512, eff. 7-1-18; 100-517, | 13 | | eff. 6-1-18; 100-646, eff. 7-27-18; 100-690, eff. 1-1-19; | 14 | | 100-863, eff. 8-14-18; 100-887, eff. 8-14-18; revised | 15 | | 10-12-18.)
| 16 | | Section 999. Effective date. This Act takes effect upon | 17 | | becoming law.
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INDEX
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Statutes amended in order of appearance
| | 3 | | New Act | | | 4 | | 5 ILCS 140/7.5 | | | 5 | | 215 ILCS 5/356z.33 new | | | 6 | | 225 ILCS 85/16d new | | | 7 | | 225 ILCS 85/19.5 | | | 8 | | 225 ILCS 85/19.7 new | | | 9 | | 225 ILCS 85/25 | from Ch. 111, par. 4145 | | 10 | | 225 ILCS 85/41 | |
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