Bill Text: IL HB0156 | 2019-2020 | 101st General Assembly | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Reenacts the Transportation Network Providers Act. Provides for the continuation and validation of the Act, and extends the repeal to June 1, 2021. Effective immediately.
Spectrum: Partisan Bill (Democrat 27-1)
Status: (Enrolled - Dead) 2021-01-13 - Passed Both Houses [HB0156 Detail]
Download: Illinois-2019-HB0156-Introduced.html
Bill Title: Reenacts the Transportation Network Providers Act. Provides for the continuation and validation of the Act, and extends the repeal to June 1, 2021. Effective immediately.
Spectrum: Partisan Bill (Democrat 27-1)
Status: (Enrolled - Dead) 2021-01-13 - Passed Both Houses [HB0156 Detail]
Download: Illinois-2019-HB0156-Introduced.html
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1 | AN ACT concerning regulation.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 1. Short title. This Act may be cited as the | ||||||||||||||||||||||||
5 | Prescription Drug Pricing Transparency Act.
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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.
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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.
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2 | Section 25. Notice of introduction of new high-cost | ||||||
3 | prescription drugs.
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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.
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20 | Section 900. The Freedom of Information Act is amended by | ||||||
21 | changing Section 7.5 as follows:
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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.
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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 |
| |||||||
| |||||||
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 905. The Illinois Insurance Code is amended by | ||||||
17 | adding Section 356z.33 as follows:
| ||||||
18 | (215 ILCS 5/356z.33 new) | ||||||
19 | Sec. 356z.33. Interchangeable biological products. | ||||||
20 | (a) As used in this Section, "interchangeable biological | ||||||
21 | product" has the same meaning given to the term in Section 19.5 | ||||||
22 | of the Pharmacy Practice Act. | ||||||
23 | (b) A group or individual policy of accident and health | ||||||
24 | insurance provided by a health insurer or by a pharmacy benefit |
| |||||||
| |||||||
1 | manager on behalf of a health insurer amended, delivered, | ||||||
2 | issued, or renewed after the effective date of this amendatory | ||||||
3 | Act of the 101st General Assembly that provides coverage for | ||||||
4 | prescription drugs shall apply the same cost-sharing | ||||||
5 | requirements to interchangeable biological products as apply | ||||||
6 | to generic drugs under the policy.
| ||||||
7 | Section 910. The Pharmacy Practice Act is amended by | ||||||
8 | changing Sections 19.5, 25, and 41 and by adding Sections 16d | ||||||
9 | and 19.7 as follows:
| ||||||
10 | (225 ILCS 85/16d new) | ||||||
11 | Sec. 16d. Information; labeling. | ||||||
12 | (a) Every pharmacy in the State shall have posted a sign in | ||||||
13 | a
prominent place that is in clear unobstructed view which | ||||||
14 | shall read: "Illinois law requires pharmacists in some cases to | ||||||
15 | select a less expensive generic equivalent drug or | ||||||
16 | interchangeable biological product for the drug or biological
| ||||||
17 | product prescribed unless you or your physician direct | ||||||
18 | otherwise. Ask your
pharmacist.". | ||||||
19 | (b) The label of the container of all drugs and biological | ||||||
20 | products dispensed
by a pharmacist under this Act shall | ||||||
21 | indicate the generic or proper name
using an abbreviation, if | ||||||
22 | necessary, the strength of the drug or biological
product, if | ||||||
23 | applicable, and the name or number of the manufacturer or
| ||||||
24 | distributor.
|
| |||||||
| |||||||
1 | (225 ILCS 85/19.5) | ||||||
2 | (Section scheduled to be repealed on January 1, 2020) | ||||||
3 | Sec. 19.5. Biological products. | ||||||
4 | (a) For the purposes of this Section: | ||||||
5 | "Biological product" has the meaning given to that term in | ||||||
6 | 42 U.S.C. 262. | ||||||
7 | "Interchangeable biological product" means a biological | ||||||
8 | product that the United States Food and Drug Administration: | ||||||
9 | (1) has (A) licensed and (B) determined it to meet the | ||||||
10 | standards for interchangeability pursuant to 42 U.S.C. | ||||||
11 | 262(k)(4); or | ||||||
12 | (2) has determined is therapeutically equivalent as | ||||||
13 | set forth in the latest edition of or supplement to the | ||||||
14 | United States Food and Drug Administration's Approved Drug | ||||||
15 | Products with Therapeutic Equivalence Evaluations (Orange | ||||||
16 | Book). | ||||||
17 | (b) When a pharmacist receives a prescription for a | ||||||
18 | biological product, the pharmacist shall select the lowest | ||||||
19 | priced interchangeable biological product unless otherwise | ||||||
20 | instructed by the prescriber, or by the purchaser if the
| ||||||
21 | purchaser agrees to pay any additional cost in excess of the | ||||||
22 | benefits provided by the purchaser's health benefit plan if | ||||||
23 | allowed under the legal requirements applicable to the plan, or | ||||||
24 | otherwise to pay the full cost for the higher priced biological | ||||||
25 | product. A pharmacist may substitute an interchangeable |
| |||||||
| |||||||
1 | biological product for a prescribed biological product only if | ||||||
2 | all of the following conditions in this subsection (b) are met: | ||||||
3 | (1) the substituted product has been determined by the | ||||||
4 | United States Food and Drug Administration to be | ||||||
5 | interchangeable, as defined in subsection (a) of this | ||||||
6 | Section, with the prescribed biological product; | ||||||
7 | (2) the prescribing physician does not designate | ||||||
8 | orally, in writing, or electronically that substitution is | ||||||
9 | prohibited in a manner consistent with Section 25 of this | ||||||
10 | Act; and | ||||||
11 | (3) the pharmacy informs the patient of the | ||||||
12 | substitution. | ||||||
13 | (c) Within 5 business days following the dispensing of a | ||||||
14 | biological product, the dispensing pharmacist or the | ||||||
15 | pharmacist's designee shall make an entry of the specific | ||||||
16 | product provided to the patient, including the name of the | ||||||
17 | product and the manufacturer. The communication shall be | ||||||
18 | conveyed by making an entry that can be electronically accessed | ||||||
19 | by the prescriber through: | ||||||
20 | (1) an interoperable electronic medical records | ||||||
21 | system; | ||||||
22 | (2) an electronic prescribing technology; | ||||||
23 | (3) a pharmacy benefit management system; or | ||||||
24 | (4) a pharmacy record. | ||||||
25 | Entry into an electronic records system as described in | ||||||
26 | this subsection (c) is presumed to provide notice in accordance |
| |||||||
| |||||||
1 | with this subsection (c). Otherwise, the pharmacist shall | ||||||
2 | communicate the biological product dispensed to the prescriber | ||||||
3 | using facsimile, telephone, electronic transmission, or other | ||||||
4 | prevailing means, except that communication shall not be | ||||||
5 | required where: | ||||||
6 | (A) there is no United States Food and Drug | ||||||
7 | Administration-approved interchangeable biological product | ||||||
8 | for the product prescribed; or | ||||||
9 | (B) a refill prescription is not changed from the | ||||||
10 | product dispensed on the prior filling of the prescription. | ||||||
11 | (d) The pharmacy shall retain a record of the biological | ||||||
12 | product dispensed for a period of 5 years. | ||||||
13 | (e) The Department shall maintain a link on its Internet | ||||||
14 | website to the current list of all biological products | ||||||
15 | determined by the United States Food and Drug Administration to | ||||||
16 | be interchangeable with a specific biological product. | ||||||
17 | (f) The Department may adopt rules for compliance with this | ||||||
18 | Section.
| ||||||
19 | (Source: P.A. 99-200, eff. 1-1-16 .)
| ||||||
20 | (225 ILCS 85/19.7 new) | ||||||
21 | Sec. 19.7. State's preferred drug list. Notwithstanding | ||||||
22 | Section 19.5, when a pharmacist receives a prescription from a | ||||||
23 | recipient of medical assistance under Article V of the Illinois | ||||||
24 | Public Aid Code, the pharmacist shall select the preferred | ||||||
25 | brand-name or generic drug or biological product from the |
| |||||||
| |||||||
1 | State's preferred drug list.
| ||||||
2 | (225 ILCS 85/25) (from Ch. 111, par. 4145)
| ||||||
3 | (Section scheduled to be repealed on January 1, 2020)
| ||||||
4 | Sec. 25. No person shall compound, or sell or offer for | ||||||
5 | sale, or
cause to be compounded, sold or offered for sale any | ||||||
6 | medicine or preparation
under or by a name recognized in the | ||||||
7 | United States Pharmacopoeia
National Formulary, for internal | ||||||
8 | or external use, which differs from
the standard of strength, | ||||||
9 | quality or purity as determined by the test
laid down in the | ||||||
10 | United States Pharmacopoeia National Formulary official at
the | ||||||
11 | time
of
such compounding, sale or offering for sale. Nor shall | ||||||
12 | any person
compound, sell or offer for sale, or cause to be | ||||||
13 | compounded, sold,
or offered for sale, any drug, medicine, | ||||||
14 | poison, chemical or pharmaceutical
preparation, the strength | ||||||
15 | or purity of which shall fall below the professed
standard of | ||||||
16 | strength or purity under which it is sold. Except as set forth | ||||||
17 | in Section 26 of this Act, if the physician
or other authorized | ||||||
18 | prescriber, when transmitting an oral or written
prescription, | ||||||
19 | does not prohibit drug product selection, a different
brand | ||||||
20 | name or nonbrand name drug product of the same generic name or | ||||||
21 | interchangeable biological product may
be dispensed by the | ||||||
22 | pharmacist, provided that the selected drug
or interchangeable | ||||||
23 | biological product has
a unit price less than the drug product | ||||||
24 | or interchangeable biological product specified in the | ||||||
25 | prescription.
A generic drug or interchangeable biological |
| |||||||
| |||||||
1 | product determined to be therapeutically equivalent by the
| ||||||
2 | United States Food and Drug Administration (FDA) shall be
| ||||||
3 | available for substitution in Illinois in accordance with this
| ||||||
4 | Act and the Illinois Food, Drug and Cosmetic Act, provided that
| ||||||
5 | each manufacturer submits to the Director of the Department of | ||||||
6 | Public Health a notification containing product
technical | ||||||
7 | bioequivalence information as a prerequisite to product
| ||||||
8 | substitution when they have completed all required testing to
| ||||||
9 | support FDA product approval and, in any event, the information
| ||||||
10 | shall be submitted no later than 60 days prior to product
| ||||||
11 | substitution in the State.
On the prescription forms of | ||||||
12 | prescribers,
shall be placed a signature line and the words
| ||||||
13 | "may not substitute". The prescriber, in his or her own | ||||||
14 | handwriting,
shall place a mark beside "may not substitute"
to | ||||||
15 | direct
the pharmacist in the dispensing of the prescription.
| ||||||
16 | Preprinted or rubber stamped marks, or other deviations from
| ||||||
17 | the above prescription format shall not be permitted. The | ||||||
18 | prescriber
shall sign the form in his or her own handwriting to | ||||||
19 | authorize the
issuance of the prescription.
| ||||||
20 | In every case in which a selection is made as permitted by | ||||||
21 | the Illinois
Food, Drug and Cosmetic Act, the pharmacist shall | ||||||
22 | indicate on the pharmacy
record of the filled prescription the | ||||||
23 | name or other identification
of the manufacturer of the drug or | ||||||
24 | interchangeable biological product which has been dispensed.
| ||||||
25 | The selection of any drug product or interchangeable | ||||||
26 | biological product by a pharmacist shall not constitute
|
| |||||||
| |||||||
1 | evidence of negligence if the selected nonlegend drug product | ||||||
2 | or interchangeable biological product was of
the same dosage | ||||||
3 | form and each of its active ingredients did not vary
by more | ||||||
4 | than 1 percent from the active ingredients of the prescribed,
| ||||||
5 | brand name, nonlegend drug product or interchangeable | ||||||
6 | biological product . Failure of a prescribing
physician to | ||||||
7 | specify that drug product or interchangeable biological | ||||||
8 | product selection is prohibited does not
constitute evidence of | ||||||
9 | negligence
unless that practitioner has reasonable cause to | ||||||
10 | believe that the health
condition of the patient for whom the | ||||||
11 | physician is prescribing warrants
the use of the brand name | ||||||
12 | drug product or interchangeable biological product and not | ||||||
13 | another.
| ||||||
14 | The Department is authorized to employ an analyst or | ||||||
15 | chemist of recognized
or approved standing whose duty it shall | ||||||
16 | be to examine into any claimed
adulteration, illegal | ||||||
17 | substitution, improper selection, alteration,
or other | ||||||
18 | violation hereof, and report the result of his investigation,
| ||||||
19 | and if such report justify such action the Department shall | ||||||
20 | cause the
offender to be prosecuted.
| ||||||
21 | (Source: P.A. 94-936, eff. 6-26-06; 95-689, eff. 10-29-07 .)
| ||||||
22 | (225 ILCS 85/41) | ||||||
23 | (Section scheduled to be repealed on January 1, 2020) | ||||||
24 | Sec. 41. Current usual and customary retail price | ||||||
25 | disclosure. Upon request, a pharmacy must disclose the current |
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
1 | usual and customary retail price of any brand or generic | |||||||||||||||||||||||||
2 | prescription drug , interchangeable biological product, or | |||||||||||||||||||||||||
3 | medical device that the pharmacy offers for sale to the public. | |||||||||||||||||||||||||
4 | This disclosure requirement applies only to requests made in | |||||||||||||||||||||||||
5 | person or by telephone for the prices of no more than 10 | |||||||||||||||||||||||||
6 | prescription drugs , interchangeable biological products, or | |||||||||||||||||||||||||
7 | medical devices for which the person making the request has a | |||||||||||||||||||||||||
8 | prescription. Prices quoted are for informational purposes | |||||||||||||||||||||||||
9 | only and are valid only on the day of inquiry. The requests | |||||||||||||||||||||||||
10 | must specify the name, strength and quantity of the | |||||||||||||||||||||||||
11 | prescription drug or interchangeable biological product .
| |||||||||||||||||||||||||
12 | (Source: P.A. 94-459, eff. 1-1-06 .)
| |||||||||||||||||||||||||
13 | Section 999. Effective date. This Act takes effect upon | |||||||||||||||||||||||||
14 | becoming law.
| |||||||||||||||||||||||||
|