101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB0156

 

Introduced , by Rep. Mary E. Flowers

 

SYNOPSIS AS INTRODUCED:
 
See Index

    Creates the Prescription Drug Pricing Transparency Act. Requires health insurers to disclose certain rate and spending information concerning prescription drugs and certain prescription drug pricing information to the Department of Public Health. Requires the Department and health insurers to create annual lists of prescription drugs on which the State spends significant health care dollars and for which costs have increased at a certain rate over time. Requires the Department and health insurers to provide their lists to the Attorney General. Requires prescription drug manufacturers to notify the Attorney General if they are introducing a new prescription drug at a wholesale acquisition cost that exceeds the threshold set for a specialty drug under the Medicare Part D program. Amends the Illinois Insurance Code. Requires a group or individual policy of accident and health insurance that provides coverage for prescription drugs to apply the same cost-sharing requirements to interchangeable biological products as apply to generic drugs under the policy. Amends the Pharmacy Practice Act. Provides that when a pharmacist receives a prescription for a biological product, the pharmacist shall select the lowest priced interchangeable biological product (rather than allowing a pharmacist to substitute an interchangeable biological product only if certain requirements are met). Requires that when a pharmacist receives a prescription from a Medicaid recipient, the pharmacist shall select the preferred drug or biological product from the State's preferred drug list. Makes other changes. Makes conforming changes in the Freedom of Information Act. Effective immediately.


LRB101 03973 SMS 48981 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB0156LRB101 03973 SMS 48981 b

1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Prescription 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
9production, preparation, propagation, compounding, conversion,
10or processing of prescription drugs, whether directly or
11indirectly by extraction from substances of natural origin,
12independently by means of chemical synthesis, or by a
13combination of extraction and chemical synthesis, or any entity
14engaged in the packaging, repackaging, labeling, relabeling,
15or distribution of prescription drugs. "Manufacturer" does not
16include a wholesale distributor of prescription drugs, a
17retailer, or a pharmacist licensed under the Pharmacy Practice
18Act.
19    "Prescription drug" means a drug as defined in 21 U.S.C.
20321.
 
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
17percentage of the premium rate attributable to prescription
18drugs administered by a health care provider in an outpatient
19setting that are part of the medical benefit as separate from
20the pharmacy benefit.
21    (c) The health insurer shall include information on its use
22of a pharmacy benefit manager, if any, including which
23components of the prescription drug coverage described in
24subsections (a) and (b) are managed by the pharmacy benefit
25manager, as well as the name of the pharmacy benefit manager or
26pharmacy benefit managers used.
 

 

 

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1    Section 15. Impact of prescription drug costs on health
2insurance premiums; report.
3    (a) Each health insurer with more than 1,000 covered lives
4in this State for major medical health insurance shall report
5to the Department for all covered prescription drugs, including
6generic drugs, brand-name drugs, and specialty drugs, provided
7in 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
15the Department the actual price paid, net of rebates, for any
16prescription drug.
17    (c) The Department shall compile the information reported
18pursuant to subsection (a) into a consumer-friendly report that
19demonstrates the overall impact of drug costs on health
20insurance premiums. The data in the report shall be aggregated
21and shall not reveal information specific to a particular
22health benefit plan.
23    (d) The Department shall publish the report required
24pursuant to subsection (a) on its website on or before January
251 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
3prescription drugs on which the State spends significant health
4care dollars and for which the wholesale acquisition cost has
5increased by 50% or more over the past 5 years or by 15% or more
6during the previous calendar year, creating a substantial
7public interest in understanding the development of the drugs'
8pricing. The list shall include at least one generic drug and
9one brand-name drug and shall indicate each of the drugs on the
10list that the Department considers to be specialty drugs. The
11Department shall include the percentage of the wholesale
12acquisition cost increase for each drug on the list; rank the
13drugs on the list from those with the largest increase in
14wholesale acquisition cost to those with the smallest increase;
15indicate whether each drug was included on the list based on
16its cost increase over the past 5 years or during the previous
17calendar year, or both; and provide the State's total
18expenditure for each drug on the list during the most recent
19calendar year.
20    (b) The Department shall create annually a list of 10
21prescription drugs on which the State spends significant health
22care dollars and for which the cost to the State, net of
23rebates and other price concessions, has increased by 50% or
24more over the past 5 years or by 15% or more during the
25previous calendar year, creating a substantial public interest

 

 

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1in understanding the development of the drugs' pricing. The
2list shall include at least one generic drug and one brand-name
3drug and shall indicate each of the drugs on the list that the
4Department considers to be specialty drugs. The Department
5shall rank the drugs on the list from those with the greatest
6increase in net cost to those with the smallest increase and
7indicate whether each drug was included on the list based on
8its cost increase over the past 5 years or during the previous
9calendar year, or both.
10    (c) Each health insurer with more than 5,000 covered lives
11in this State for major medical health insurance shall create
12annually a list of 10 prescription drugs on which its health
13insurance plans spend significant amounts of their premium
14dollars and for which the cost to the plans, net of rebates and
15other price concessions, has increased by 50% or more over the
16past 5 years or by 15% or more during the previous calendar
17year, or both, creating a substantial public interest in
18understanding the development of the drugs' pricing. The list
19shall include at least one generic drug and one brand-name drug
20and shall indicate each of the drugs on the list that the
21health insurer considers to be specialty drugs. The health
22insurer shall rank the drugs on the list from those with the
23greatest increase in net cost to those with the smallest
24increase and indicate whether each drug was included on the
25list based on its cost increase over the past 5 years or during
26the previous calendar year, or both.

 

 

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1    (d) Each health insurer creating a list pursuant to
2subsection (c) shall provide to the Office of the Attorney
3General the percentage by which the net cost to its plans
4increased over the applicable period or periods for each drug
5on the list, as well as the health insurer's total expenditure,
6net of rebates and other price concessions, for each drug on
7the list during the most recent calendar year. Information
8provided to the Office of the Attorney General pursuant to this
9subsection is exempt from public inspection and copying under
10the Freedom of Information Act and shall not be released.
11    (e) The Department and the health insurers shall provide to
12the Office of the Attorney General the lists of prescription
13drugs developed pursuant to subsections (a), (b), and (c)
14annually on or before June 1. The Office of the Attorney
15General shall make all of the information available to the
16public on its website.
17    (f) Of the prescription drugs listed by the Department and
18the health insurers pursuant to subsections (a), (b), and (c),
19the 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
6Attorney General pursuant to subsection (f), the Office of the
7Attorney General shall require the manufacturer of each such
8drug 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
17the legal ability of a prescription drug manufacturer to change
18prices to the extent permitted under federal law.
19    (i) The Attorney General shall provide a report to the
20General Assembly on or before December 1 of each year based on
21the information received from manufacturers pursuant to this
22Section. The report to the General Assembly shall be filed with
23the Clerk of the House of Representatives and the Secretary of
24the Senate in electronic form only, in the manner that the
25Clerk and the Secretary shall direct. The Attorney General
26shall post the report and the public version of each

 

 

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1manufacturer's information submitted pursuant to paragraph (2)
2of subsection (g) on the Office of the Attorney General's
3website.
4    (j) The Department shall post on its website the report
5prepared by the Attorney General pursuant to subsection (i) and
6the public version of each manufacturer's information
7submitted pursuant to paragraph (2) of subsection (g) and may
8inform the public of the availability of the report and the
9manufacturers' justification information.
10    (k) Information provided to the Office of the Attorney
11General pursuant to subsection (g) is exempt from public
12inspection and copying under the Freedom of Information Act and
13shall not be released in a manner that allows for the
14identification of an individual drug or manufacturer or that is
15likely to compromise the financial, competitive, or
16proprietary nature of the information, except for the
17information prepared for release to the public pursuant to
18paragraph (2) of subsection (g).
19    (l) The Attorney General may bring an action in the circuit
20court of Sangamon County for injunctive relief, costs, and
21attorney's fees and to impose on a manufacturer that fails to
22provide any of the information required by subsections (f) and
23(g), in the format requested by the Office of the Attorney
24General and in accordance with the timeline specified by the
25Office of the Attorney General, a civil penalty of not more
26than $10,000 per violation. Each unlawful failure to provide

 

 

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1information shall constitute a separate violation.
 
2    Section 25. Notice of introduction of new high-cost
3prescription drugs.
4    (a) A manufacturer shall notify the Office of the Attorney
5General in writing if it is introducing a new prescription drug
6to market at a wholesale acquisition cost that exceeds the
7threshold set for a specialty drug under the Medicare Part D
8program. The manufacturer shall provide the written notice
9within 3 calendar days following the release of the drug in the
10commercial market. A manufacturer may make the notification
11pending approval by the United States Food and Drug
12Administration if commercial availability is expected within 3
13calendar days following the approval.
14    (b) Not later than 30 calendar days following notification
15pursuant to subsection (a), the manufacturer shall provide all
16of the following information to the Office of the Attorney
17General in a format that the Office of the Attorney General
18prescribes:
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
5pursuant to subsection (b) to that which is otherwise in the
6public domain or publicly available.
7    (d) The Office of the Attorney General shall publish on its
8website at least quarterly the information reported to it
9pursuant to this Section. The information shall be published in
10a manner that identifies the information that is disclosed on a
11per-drug basis and shall not be aggregated in a manner that
12would not allow identification of the drug.
13    (e) The Attorney General may bring an action in the circuit
14court of Sangamon County for injunctive relief, costs, and
15attorney's fees and to impose on a manufacturer that fails to
16provide the information required by subsection (b) a civil
17penalty of not more than $1,000 per day for every day after the
18notification period described in subsection (a) that the
19required information is not reported.
 
20    Section 900. The Freedom of Information Act is amended by
21changing Section 7.5 as follows:
 
22    (5 ILCS 140/7.5)
23    Sec. 7.5. Statutory exemptions. To the extent provided for
24by the statutes referenced below, the following shall be exempt

 

 

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1from 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,
9eff. 1-1-16; 99-642, eff. 7-28-16; 99-776, eff. 8-12-16;
1099-863, eff. 8-19-16; 100-20, eff. 7-1-17; 100-22, eff. 1-1-18;
11100-201, eff. 8-18-17; 100-373, eff. 1-1-18; 100-464, eff.
128-28-17; 100-465, eff. 8-31-17; 100-512, eff. 7-1-18; 100-517,
13eff. 6-1-18; 100-646, eff. 7-27-18; 100-690, eff. 1-1-19;
14100-863, eff. 8-14-18; 100-887, eff. 8-14-18; revised
1510-12-18.)
 
16    Section 905. The Illinois Insurance Code is amended by
17adding 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
21product" has the same meaning given to the term in Section 19.5
22of the Pharmacy Practice Act.
23    (b) A group or individual policy of accident and health
24insurance provided by a health insurer or by a pharmacy benefit

 

 

HB0156- 19 -LRB101 03973 SMS 48981 b

1manager on behalf of a health insurer amended, delivered,
2issued, or renewed after the effective date of this amendatory
3Act of the 101st General Assembly that provides coverage for
4prescription drugs shall apply the same cost-sharing
5requirements to interchangeable biological products as apply
6to generic drugs under the policy.
 
7    Section 910. The Pharmacy Practice Act is amended by
8changing Sections 19.5, 25, and 41 and by adding Sections 16d
9and 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
13a prominent place that is in clear unobstructed view which
14shall read: "Illinois law requires pharmacists in some cases to
15select a less expensive generic equivalent drug or
16interchangeable biological product for the drug or biological
17product prescribed unless you or your physician direct
18otherwise. Ask your pharmacist.".
19    (b) The label of the container of all drugs and biological
20products dispensed by a pharmacist under this Act shall
21indicate the generic or proper name using an abbreviation, if
22necessary, the strength of the drug or biological product, if
23applicable, and the name or number of the manufacturer or
24distributor.
 

 

 

HB0156- 20 -LRB101 03973 SMS 48981 b

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
642 U.S.C. 262.
7    "Interchangeable biological product" means a biological
8product 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
18biological product, the pharmacist shall select the lowest
19priced interchangeable biological product unless otherwise
20instructed by the prescriber, or by the purchaser if the
21purchaser agrees to pay any additional cost in excess of the
22benefits provided by the purchaser's health benefit plan if
23allowed under the legal requirements applicable to the plan, or
24otherwise to pay the full cost for the higher priced biological
25product. A pharmacist may substitute an interchangeable

 

 

HB0156- 21 -LRB101 03973 SMS 48981 b

1biological product for a prescribed biological product only if
2all 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
14biological product, the dispensing pharmacist or the
15pharmacist's designee shall make an entry of the specific
16product provided to the patient, including the name of the
17product and the manufacturer. The communication shall be
18conveyed by making an entry that can be electronically accessed
19by 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
26this subsection (c) is presumed to provide notice in accordance

 

 

HB0156- 22 -LRB101 03973 SMS 48981 b

1with this subsection (c). Otherwise, the pharmacist shall
2communicate the biological product dispensed to the prescriber
3using facsimile, telephone, electronic transmission, or other
4prevailing means, except that communication shall not be
5required 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
12product dispensed for a period of 5 years.
13    (e) The Department shall maintain a link on its Internet
14website to the current list of all biological products
15determined by the United States Food and Drug Administration to
16be interchangeable with a specific biological product.
17    (f) The Department may adopt rules for compliance with this
18Section.
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
22Section 19.5, when a pharmacist receives a prescription from a
23recipient of medical assistance under Article V of the Illinois
24Public Aid Code, the pharmacist shall select the preferred
25brand-name or generic drug or biological product from the

 

 

HB0156- 23 -LRB101 03973 SMS 48981 b

1State'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
5sale, or cause to be compounded, sold or offered for sale any
6medicine or preparation under or by a name recognized in the
7United States Pharmacopoeia National Formulary, for internal
8or external use, which differs from the standard of strength,
9quality or purity as determined by the test laid down in the
10United States Pharmacopoeia National Formulary official at the
11time of such compounding, sale or offering for sale. Nor shall
12any person compound, sell or offer for sale, or cause to be
13compounded, sold, or offered for sale, any drug, medicine,
14poison, chemical or pharmaceutical preparation, the strength
15or purity of which shall fall below the professed standard of
16strength or purity under which it is sold. Except as set forth
17in Section 26 of this Act, if the physician or other authorized
18prescriber, when transmitting an oral or written prescription,
19does not prohibit drug product selection, a different brand
20name or nonbrand name drug product of the same generic name or
21interchangeable biological product may be dispensed by the
22pharmacist, provided that the selected drug or interchangeable
23biological product has a unit price less than the drug product
24or interchangeable biological product specified in the
25prescription. A generic drug or interchangeable biological

 

 

HB0156- 24 -LRB101 03973 SMS 48981 b

1product determined to be therapeutically equivalent by the
2United States Food and Drug Administration (FDA) shall be
3available for substitution in Illinois in accordance with this
4Act and the Illinois Food, Drug and Cosmetic Act, provided that
5each manufacturer submits to the Director of the Department of
6Public Health a notification containing product technical
7bioequivalence information as a prerequisite to product
8substitution when they have completed all required testing to
9support FDA product approval and, in any event, the information
10shall be submitted no later than 60 days prior to product
11substitution in the State. On the prescription forms of
12prescribers, shall be placed a signature line and the words
13"may not substitute". The prescriber, in his or her own
14handwriting, shall place a mark beside "may not substitute" to
15direct the pharmacist in the dispensing of the prescription.
16Preprinted or rubber stamped marks, or other deviations from
17the above prescription format shall not be permitted. The
18prescriber shall sign the form in his or her own handwriting to
19authorize the issuance of the prescription.
20    In every case in which a selection is made as permitted by
21the Illinois Food, Drug and Cosmetic Act, the pharmacist shall
22indicate on the pharmacy record of the filled prescription the
23name or other identification of the manufacturer of the drug or
24interchangeable biological product which has been dispensed.
25    The selection of any drug product or interchangeable
26biological product by a pharmacist shall not constitute

 

 

HB0156- 25 -LRB101 03973 SMS 48981 b

1evidence of negligence if the selected nonlegend drug product
2or interchangeable biological product was of the same dosage
3form and each of its active ingredients did not vary by more
4than 1 percent from the active ingredients of the prescribed,
5brand name, nonlegend drug product or interchangeable
6biological product. Failure of a prescribing physician to
7specify that drug product or interchangeable biological
8product selection is prohibited does not constitute evidence of
9negligence unless that practitioner has reasonable cause to
10believe that the health condition of the patient for whom the
11physician is prescribing warrants the use of the brand name
12drug product or interchangeable biological product and not
13another.
14    The Department is authorized to employ an analyst or
15chemist of recognized or approved standing whose duty it shall
16be to examine into any claimed adulteration, illegal
17substitution, improper selection, alteration, or other
18violation hereof, and report the result of his investigation,
19and if such report justify such action the Department shall
20cause 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
25disclosure. Upon request, a pharmacy must disclose the current

 

 

HB0156- 26 -LRB101 03973 SMS 48981 b

1usual and customary retail price of any brand or generic
2prescription drug, interchangeable biological product, or
3medical device that the pharmacy offers for sale to the public.
4This disclosure requirement applies only to requests made in
5person or by telephone for the prices of no more than 10
6prescription drugs, interchangeable biological products, or
7medical devices for which the person making the request has a
8prescription. Prices quoted are for informational purposes
9only and are valid only on the day of inquiry. The requests
10must specify the name, strength and quantity of the
11prescription 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
14becoming law.

 

 

HB0156- 27 -LRB101 03973 SMS 48981 b

1 INDEX
2 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 85/25from Ch. 111, par. 4145
10    225 ILCS 85/41