104TH GENERAL ASSEMBLY
State of Illinois
2025 and 2026
HB3794

 

Introduced 2/18/2025, by Rep. Ryan Spain

 

SYNOPSIS AS INTRODUCED:
 
5 ILCS 140/7.5
215 ILCS 5/513b1
225 ILCS 85/19.5

    Amends the Pharmacy Benefit Manager Article of the Illinois Insurance Code. Provides that a covered individual's defined cost sharing for each prescription drug shall be calculated at the point of sale based on a price that is reduced by an amount equal to at least 80% of all rebates received, or to be received, or to be received, in connection with the dispensing or administration of the prescription drug. Provides that a health insurer or its agents shall not publish or otherwise reveal information regarding the actual amount of rebates a health insurer receives on a product or therapeutic class of products, manufacturer-specific basis, or pharmacy-specific basis and that the information is confidential. Defines terms. Amends the Freedom of Information Act to make a conforming change. Amends the Pharmacy Practice Act. Provides that a pharmacist may substitute a biological product (instead of an interchangeable biological product) if, among other requirements, the product being considered for substitution is either the reference product or a product approved by the United States Food and Drug Administration as a biosimilar of the prescribed biological product (instead of if the substituted product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product). Makes conforming changes.


LRB104 10437 BAB 20512 b

 

 

A BILL FOR

 

HB3794LRB104 10437 BAB 20512 b

1    AN ACT concerning prescription drugs.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Freedom of Information Act is amended by
5changing Section 7.5 as follows:
 
6    (5 ILCS 140/7.5)
7    Sec. 7.5. Statutory exemptions. To the extent provided for
8by the statutes referenced below, the following shall be
9exempt from inspection and copying:
10        (a) All information determined to be confidential
11    under Section 4002 of the Technology Advancement and
12    Development Act.
13        (b) Library circulation and order records identifying
14    library users with specific materials under the Library
15    Records Confidentiality Act.
16        (c) Applications, related documents, and medical
17    records received by the Experimental Organ Transplantation
18    Procedures Board and any and all documents or other
19    records prepared by the Experimental Organ Transplantation
20    Procedures Board or its staff relating to applications it
21    has received.
22        (d) Information and records held by the Department of
23    Public Health and its authorized representatives relating

 

 

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1    to known or suspected cases of sexually transmitted
2    infection or any information the disclosure of which is
3    restricted under the Illinois Sexually Transmitted
4    Infection Control Act.
5        (e) Information the disclosure of which is exempted
6    under Section 30 of the Radon Industry Licensing Act.
7        (f) Firm performance evaluations under Section 55 of
8    the Architectural, Engineering, and Land Surveying
9    Qualifications Based Selection Act.
10        (g) Information the disclosure of which is restricted
11    and exempted under Section 50 of the Illinois Prepaid
12    Tuition Act.
13        (h) Information the disclosure of which is exempted
14    under the State Officials and Employees Ethics Act, and
15    records of any lawfully created State or local inspector
16    general's office that would be exempt if created or
17    obtained by an Executive Inspector General's office under
18    that Act.
19        (i) Information contained in a local emergency energy
20    plan submitted to a municipality in accordance with a
21    local emergency energy plan ordinance that is adopted
22    under Section 11-21.5-5 of the Illinois Municipal Code.
23        (j) Information and data concerning the distribution
24    of surcharge moneys collected and remitted by carriers
25    under the Emergency Telephone System Act.
26        (k) Law enforcement officer identification information

 

 

HB3794- 3 -LRB104 10437 BAB 20512 b

1    or driver identification information compiled by a law
2    enforcement agency or the Department of Transportation
3    under Section 11-212 of the Illinois Vehicle Code.
4        (l) Records and information provided to a residential
5    health care facility resident sexual assault and death
6    review team or the Executive Council under the Abuse
7    Prevention Review Team Act.
8        (m) Information provided to the predatory lending
9    database created pursuant to Article 3 of the Residential
10    Real Property Disclosure Act, except to the extent
11    authorized under that Article.
12        (n) Defense budgets and petitions for certification of
13    compensation and expenses for court appointed trial
14    counsel as provided under Sections 10 and 15 of the
15    Capital Crimes Litigation Act (repealed). This subsection
16    (n) shall apply until the conclusion of the trial of the
17    case, even if the prosecution chooses not to pursue the
18    death penalty prior to trial or sentencing.
19        (o) Information that is prohibited from being
20    disclosed under Section 4 of the Illinois Health and
21    Hazardous Substances Registry Act.
22        (p) Security portions of system safety program plans,
23    investigation reports, surveys, schedules, lists, data, or
24    information compiled, collected, or prepared by or for the
25    Department of Transportation under Sections 2705-300 and
26    2705-616 of the Department of Transportation Law of the

 

 

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1    Civil Administrative Code of Illinois, the Regional
2    Transportation Authority under Section 2.11 of the
3    Regional Transportation Authority Act, or the St. Clair
4    County Transit District under the Bi-State Transit Safety
5    Act (repealed).
6        (q) Information prohibited from being disclosed by the
7    Personnel Record Review Act.
8        (r) Information prohibited from being disclosed by the
9    Illinois School Student Records Act.
10        (s) Information the disclosure of which is restricted
11    under Section 5-108 of the Public Utilities Act.
12        (t) (Blank).
13        (u) Records and information provided to an independent
14    team of experts under the Developmental Disability and
15    Mental Health Safety Act (also known as Brian's Law).
16        (v) Names and information of people who have applied
17    for or received Firearm Owner's Identification Cards under
18    the Firearm Owners Identification Card Act or applied for
19    or received a concealed carry license under the Firearm
20    Concealed Carry Act, unless otherwise authorized by the
21    Firearm Concealed Carry Act; and databases under the
22    Firearm Concealed Carry Act, records of the Concealed
23    Carry Licensing Review Board under the Firearm Concealed
24    Carry Act, and law enforcement agency objections under the
25    Firearm Concealed Carry Act.
26        (v-5) Records of the Firearm Owner's Identification

 

 

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1    Card Review Board that are exempted from disclosure under
2    Section 10 of the Firearm Owners Identification Card Act.
3        (w) Personally identifiable information which is
4    exempted from disclosure under subsection (g) of Section
5    19.1 of the Toll Highway Act.
6        (x) Information which is exempted from disclosure
7    under Section 5-1014.3 of the Counties Code or Section
8    8-11-21 of the Illinois Municipal Code.
9        (y) Confidential information under the Adult
10    Protective Services Act and its predecessor enabling
11    statute, the Elder Abuse and Neglect Act, including
12    information about the identity and administrative finding
13    against any caregiver of a verified and substantiated
14    decision of abuse, neglect, or financial exploitation of
15    an eligible adult maintained in the Registry established
16    under Section 7.5 of the Adult Protective Services Act.
17        (z) Records and information provided to a fatality
18    review team or the Illinois Fatality Review Team Advisory
19    Council under Section 15 of the Adult Protective Services
20    Act.
21        (aa) Information which is exempted from disclosure
22    under Section 2.37 of the Wildlife Code.
23        (bb) Information which is or was prohibited from
24    disclosure by the Juvenile Court Act of 1987.
25        (cc) Recordings made under the Law Enforcement
26    Officer-Worn Body Camera Act, except to the extent

 

 

HB3794- 6 -LRB104 10437 BAB 20512 b

1    authorized under that Act.
2        (dd) Information that is prohibited from being
3    disclosed under Section 45 of the Condominium and Common
4    Interest Community Ombudsperson Act.
5        (ee) Information that is exempted from disclosure
6    under Section 30.1 of the Pharmacy Practice Act.
7        (ff) Information that is exempted from disclosure
8    under the Revised Uniform Unclaimed Property Act.
9        (gg) Information that is prohibited from being
10    disclosed under Section 7-603.5 of the Illinois Vehicle
11    Code.
12        (hh) Records that are exempt from disclosure under
13    Section 1A-16.7 of the Election Code.
14        (ii) Information which is exempted from disclosure
15    under Section 2505-800 of the Department of Revenue Law of
16    the Civil Administrative Code of Illinois.
17        (jj) Information and reports that are required to be
18    submitted to the Department of Labor by registering day
19    and temporary labor service agencies but are exempt from
20    disclosure under subsection (a-1) of Section 45 of the Day
21    and Temporary Labor Services Act.
22        (kk) Information prohibited from disclosure under the
23    Seizure and Forfeiture Reporting Act.
24        (ll) Information the disclosure of which is restricted
25    and exempted under Section 5-30.8 of the Illinois Public
26    Aid Code.

 

 

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1        (mm) Records that are exempt from disclosure under
2    Section 4.2 of the Crime Victims Compensation Act.
3        (nn) Information that is exempt from disclosure under
4    Section 70 of the Higher Education Student Assistance Act.
5        (oo) Communications, notes, records, and reports
6    arising out of a peer support counseling session
7    prohibited from disclosure under the First Responders
8    Suicide Prevention Act.
9        (pp) Names and all identifying information relating to
10    an employee of an emergency services provider or law
11    enforcement agency under the First Responders Suicide
12    Prevention Act.
13        (qq) Information and records held by the Department of
14    Public Health and its authorized representatives collected
15    under the Reproductive Health Act.
16        (rr) Information that is exempt from disclosure under
17    the Cannabis Regulation and Tax Act.
18        (ss) Data reported by an employer to the Department of
19    Human Rights pursuant to Section 2-108 of the Illinois
20    Human Rights Act.
21        (tt) Recordings made under the Children's Advocacy
22    Center Act, except to the extent authorized under that
23    Act.
24        (uu) Information that is exempt from disclosure under
25    Section 50 of the Sexual Assault Evidence Submission Act.
26        (vv) Information that is exempt from disclosure under

 

 

HB3794- 8 -LRB104 10437 BAB 20512 b

1    subsections (f) and (j) of Section 5-36 of the Illinois
2    Public Aid Code.
3        (ww) Information that is exempt from disclosure under
4    Section 16.8 of the State Treasurer Act.
5        (xx) Information that is exempt from disclosure or
6    information that shall not be made public under the
7    Illinois Insurance Code.
8        (yy) Information prohibited from being disclosed under
9    the Illinois Educational Labor Relations Act.
10        (zz) Information prohibited from being disclosed under
11    the Illinois Public Labor Relations Act.
12        (aaa) Information prohibited from being disclosed
13    under Section 1-167 of the Illinois Pension Code.
14        (bbb) Information that is prohibited from disclosure
15    by the Illinois Police Training Act and the Illinois State
16    Police Act.
17        (ccc) Records exempt from disclosure under Section
18    2605-304 of the Illinois State Police Law of the Civil
19    Administrative Code of Illinois.
20        (ddd) Information prohibited from being disclosed
21    under Section 35 of the Address Confidentiality for
22    Victims of Domestic Violence, Sexual Assault, Human
23    Trafficking, or Stalking Act.
24        (eee) Information prohibited from being disclosed
25    under subsection (b) of Section 75 of the Domestic
26    Violence Fatality Review Act.

 

 

HB3794- 9 -LRB104 10437 BAB 20512 b

1        (fff) Images from cameras under the Expressway Camera
2    Act. This subsection (fff) is inoperative on and after
3    July 1, 2025.
4        (ggg) Information prohibited from disclosure under
5    paragraph (3) of subsection (a) of Section 14 of the Nurse
6    Agency Licensing Act.
7        (hhh) Information submitted to the Illinois State
8    Police in an affidavit or application for an assault
9    weapon endorsement, assault weapon attachment endorsement,
10    .50 caliber rifle endorsement, or .50 caliber cartridge
11    endorsement under the Firearm Owners Identification Card
12    Act.
13        (iii) Data exempt from disclosure under Section 50 of
14    the School Safety Drill Act.
15        (jjj) Information exempt from disclosure under Section
16    30 of the Insurance Data Security Law.
17        (kkk) Confidential business information prohibited
18    from disclosure under Section 45 of the Paint Stewardship
19    Act.
20        (lll) Data exempt from disclosure under Section
21    2-3.196 of the School Code.
22        (mmm) Information prohibited from being disclosed
23    under subsection (e) of Section 1-129 of the Illinois
24    Power Agency Act.
25        (nnn) Materials received by the Department of Commerce
26    and Economic Opportunity that are confidential under the

 

 

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1    Music and Musicians Tax Credit and Jobs Act.
2        (ooo) (nnn) Data or information provided pursuant to
3    Section 20 of the Statewide Recycling Needs and Assessment
4    Act.
5        (ppp) (nnn) Information that is exempt from disclosure
6    under Section 28-11 of the Lawful Health Care Activity
7    Act.
8        (qqq) (nnn) Information that is exempt from disclosure
9    under Section 7-101 of the Illinois Human Rights Act.
10        (rrr) (mmm) Information prohibited from being
11    disclosed under Section 4-2 of the Uniform Money
12    Transmission Modernization Act.
13        (sss) (nnn) Information exempt from disclosure under
14    Section 40 of the Student-Athlete Endorsement Rights Act.
15        (ttt) Information prohibited from being disclosed
16    under subsection (g-5) of Section 513b1 of the Illinois
17    Insurance Code.
18(Source: P.A. 102-36, eff. 6-25-21; 102-237, eff. 1-1-22;
19102-292, eff. 1-1-22; 102-520, eff. 8-20-21; 102-559, eff.
208-20-21; 102-813, eff. 5-13-22; 102-946, eff. 7-1-22;
21102-1042, eff. 6-3-22; 102-1116, eff. 1-10-23; 103-8, eff.
226-7-23; 103-34, eff. 6-9-23; 103-142, eff. 1-1-24; 103-372,
23eff. 1-1-24; 103-472, eff. 8-1-24; 103-508, eff. 8-4-23;
24103-580, eff. 12-8-23; 103-592, eff. 6-7-24; 103-605, eff.
257-1-24; 103-636, eff. 7-1-24; 103-724, eff. 1-1-25; 103-786,
26eff. 8-7-24; 103-859, eff. 8-9-24; 103-991, eff. 8-9-24;

 

 

HB3794- 11 -LRB104 10437 BAB 20512 b

1103-1049, eff. 8-9-24; revised 11-26-24.)
 
2    Section 10. The Illinois Insurance Code is amended by
3changing Section 513b1 as follows:
 
4    (215 ILCS 5/513b1)
5    Sec. 513b1. Pharmacy benefit manager contracts.
6    (a) As used in this Section:
7    "340B drug discount program" means the program established
8under Section 340B of the federal Public Health Service Act,
942 U.S.C. 256b.
10    "340B entity" means a covered entity as defined in 42
11U.S.C. 256b(a)(4) authorized to participate in the 340B drug
12discount program.
13    "340B pharmacy" means any pharmacy used to dispense 340B
14drugs for a covered entity, whether entity-owned or external.
15    "Biological product" has the meaning ascribed to that term
16in Section 19.5 of the Pharmacy Practice Act.
17    "Defined cost sharing" means a deductible payment or
18coinsurance amount imposed on an enrollee for a covered
19prescription drug under the enrollee's health benefit plan.
20    "Maximum allowable cost" means the maximum amount that a
21pharmacy benefit manager will reimburse a pharmacy for the
22cost of a drug.
23    "Maximum allowable cost list" means a list of drugs for
24which a maximum allowable cost has been established by a

 

 

HB3794- 12 -LRB104 10437 BAB 20512 b

1pharmacy benefit manager.
2    "Pharmacy benefit manager" means a person, business, or
3entity, including a wholly or partially owned or controlled
4subsidiary of a pharmacy benefit manager, that provides claims
5processing services or other prescription drug or device
6services, or both, for health benefit plans.
7    "Price protection rebate" means a negotiated price
8concession that accrues directly or indirectly to a health
9insurer, or other party on behalf of the health insurer, if
10there is an increase in the wholesale acquisition cost of a
11prescription drug above a specified threshold.
12    "Rebate" means:
13        (1) a negotiated price concession, including, without
14    limitation, base price concessions, whether described as a
15    rebate or not, reasonable estimates of any price
16    protection rebates, or performance-based price concessions
17    that may accrue, directly or indirectly, to the health
18    insurer during the coverage year from a manufacturer or
19    other party in connection with the dispensing or
20    administration of a prescription drug; or
21        (2) any reasonable estimate of a negotiated price
22    concession, fee, or other administrative cost that is
23    passed through, or is reasonably anticipated to be passed
24    through, to the health insurer and serves to reduce the
25    health insurer's liabilities for a prescription drug.
26    "Retail price" means the price an individual without

 

 

HB3794- 13 -LRB104 10437 BAB 20512 b

1prescription drug coverage would pay at a retail pharmacy, not
2including a pharmacist dispensing fee.
3    "Third-party payer" means any entity that pays for
4prescription drugs on behalf of a patient other than a health
5care provider or sponsor of a plan subject to regulation under
6Medicare Part D, 42 U.S.C. 1395w-101 et seq.
7    (b) A contract between a health insurer and a pharmacy
8benefit manager must require that the pharmacy benefit
9manager:
10        (1) Update maximum allowable cost pricing information
11    at least every 7 calendar days.
12        (2) Maintain a process that will, in a timely manner,
13    eliminate drugs from maximum allowable cost lists or
14    modify drug prices to remain consistent with changes in
15    pricing data used in formulating maximum allowable cost
16    prices and product availability.
17        (3) Provide access to its maximum allowable cost list
18    to each pharmacy or pharmacy services administrative
19    organization subject to the maximum allowable cost list.
20    Access may include a real-time pharmacy website portal to
21    be able to view the maximum allowable cost list. As used in
22    this Section, "pharmacy services administrative
23    organization" means an entity operating within the State
24    that contracts with independent pharmacies to conduct
25    business on their behalf with third-party payers. A
26    pharmacy services administrative organization may provide

 

 

HB3794- 14 -LRB104 10437 BAB 20512 b

1    administrative services to pharmacies and negotiate and
2    enter into contracts with third-party payers or pharmacy
3    benefit managers on behalf of pharmacies.
4        (4) Provide a process by which a contracted pharmacy
5    can appeal the provider's reimbursement for a drug subject
6    to maximum allowable cost pricing. The appeals process
7    must, at a minimum, include the following:
8            (A) A requirement that a contracted pharmacy has
9        14 calendar days after the applicable fill date to
10        appeal a maximum allowable cost if the reimbursement
11        for the drug is less than the net amount that the
12        network provider paid to the supplier of the drug.
13            (B) A requirement that a pharmacy benefit manager
14        must respond to a challenge within 14 calendar days of
15        the contracted pharmacy making the claim for which the
16        appeal has been submitted.
17            (C) A telephone number and e-mail address or
18        website to network providers, at which the provider
19        can contact the pharmacy benefit manager to process
20        and submit an appeal.
21            (D) A requirement that, if an appeal is denied,
22        the pharmacy benefit manager must provide the reason
23        for the denial and the name and the national drug code
24        number from national or regional wholesalers.
25            (E) A requirement that, if an appeal is sustained,
26        the pharmacy benefit manager must make an adjustment

 

 

HB3794- 15 -LRB104 10437 BAB 20512 b

1        in the drug price effective the date the challenge is
2        resolved and make the adjustment applicable to all
3        similarly situated network pharmacy providers, as
4        determined by the managed care organization or
5        pharmacy benefit manager.
6        (5) Allow a plan sponsor contracting with a pharmacy
7    benefit manager an annual right to audit compliance with
8    the terms of the contract by the pharmacy benefit manager,
9    including, but not limited to, full disclosure of any and
10    all rebate amounts secured, whether product specific or
11    generalized rebates, that were provided to the pharmacy
12    benefit manager by a pharmaceutical manufacturer.
13        (6) Allow a plan sponsor contracting with a pharmacy
14    benefit manager to request that the pharmacy benefit
15    manager disclose the actual amounts paid by the pharmacy
16    benefit manager to the pharmacy.
17        (7) Provide notice to the party contracting with the
18    pharmacy benefit manager of any consideration that the
19    pharmacy benefit manager receives from the manufacturer
20    for dispense as written prescriptions once a generic or
21    biologically similar product becomes available.
22    (c) In order to place a particular prescription drug on a
23maximum allowable cost list, the pharmacy benefit manager
24must, at a minimum, ensure that:
25        (1) if the drug is a generically equivalent drug, it
26    is listed as therapeutically equivalent and

 

 

HB3794- 16 -LRB104 10437 BAB 20512 b

1    pharmaceutically equivalent "A" or "B" rated in the United
2    States Food and Drug Administration's most recent version
3    of the "Orange Book" or have an NR or NA rating by
4    Medi-Span, Gold Standard, or a similar rating by a
5    nationally recognized reference;
6        (2) the drug is available for purchase by each
7    pharmacy in the State from national or regional
8    wholesalers operating in Illinois; and
9        (3) the drug is not obsolete.
10    (d) A pharmacy benefit manager is prohibited from limiting
11a pharmacist's ability to disclose whether the cost-sharing
12obligation exceeds the retail price for a covered prescription
13drug, and the availability of a more affordable alternative
14drug, if one is available in accordance with Section 42 of the
15Pharmacy Practice Act.
16    (e) A health insurer or pharmacy benefit manager shall not
17require an insured to make a payment for a prescription drug at
18the point of sale in an amount that exceeds the lesser of:
19        (1) the applicable cost-sharing amount; or
20        (2) the retail price of the drug in the absence of
21    prescription drug coverage.
22    (f) Unless required by law, a contract between a pharmacy
23benefit manager or third-party payer and a 340B entity or 340B
24pharmacy shall not contain any provision that:
25        (1) distinguishes between drugs purchased through the
26    340B drug discount program and other drugs when

 

 

HB3794- 17 -LRB104 10437 BAB 20512 b

1    determining reimbursement or reimbursement methodologies,
2    or contains otherwise less favorable payment terms or
3    reimbursement methodologies for 340B entities or 340B
4    pharmacies when compared to similarly situated non-340B
5    entities;
6        (2) imposes any fee, chargeback, or rate adjustment
7    that is not similarly imposed on similarly situated
8    pharmacies that are not 340B entities or 340B pharmacies;
9        (3) imposes any fee, chargeback, or rate adjustment
10    that exceeds the fee, chargeback, or rate adjustment that
11    is not similarly imposed on similarly situated pharmacies
12    that are not 340B entities or 340B pharmacies;
13        (4) prevents or interferes with an individual's choice
14    to receive a covered prescription drug from a 340B entity
15    or 340B pharmacy through any legally permissible means,
16    except that nothing in this paragraph shall prohibit the
17    establishment of differing copayments or other
18    cost-sharing amounts within the benefit plan for covered
19    persons who acquire covered prescription drugs from a
20    nonpreferred or nonparticipating provider;
21        (5) excludes a 340B entity or 340B pharmacy from a
22    pharmacy network on any basis that includes consideration
23    of whether the 340B entity or 340B pharmacy participates
24    in the 340B drug discount program;
25        (6) prevents a 340B entity or 340B pharmacy from using
26    a drug purchased under the 340B drug discount program; or

 

 

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1        (7) any other provision that discriminates against a
2    340B entity or 340B pharmacy by treating the 340B entity
3    or 340B pharmacy differently than non-340B entities or
4    non-340B pharmacies for any reason relating to the
5    entity's participation in the 340B drug discount program.
6     (g-5) A covered individual's defined cost sharing for
7each prescription drug shall be calculated at the point of
8sale based on a price that is reduced by an amount equal to at
9least 80% of all rebates received or to be received in
10connection with the dispensing or administration of the
11prescription drug.
12    In complying with this Section, a health insurer or its
13agents shall not publish or otherwise reveal information
14regarding the actual amount of rebates a health insurer
15receives on a product or therapeutic class of products,
16manufacturer-specific basis, or pharmacy-specific basis. The
17information described in this subsection is: (i) considered
18protected as a trade secret; (ii) considered proprietary and
19confidential; (iii) not subject to disclosure under the
20federal Freedom of Information Act or the Freedom of
21Information Act; and (iv) not to be disclosed directly,
22indirectly, or in a manner that would either allow for the
23identification of an individual product, therapeutic class of
24products, or manufacturer or have the potential to compromise
25the financial, competitive, or proprietary nature of the
26information. A health insurer shall impose the confidentiality

 

 

HB3794- 19 -LRB104 10437 BAB 20512 b

1protections of this subsection on any vendor or other third
2party that performs health care or administrative services on
3behalf of the health insurer that may receive or have access to
4rebate information.
5    Nothing in this subsection precludes a pharmacy benefit
6manager or insurer from reducing an insured's cost sharing by
7an amount greater than that required under this subsection.
8    As used in this subsection, "pharmacy benefit manager" and
9"third-party payer" do not include pharmacy benefit managers
10and third-party payers acting on behalf of a Medicaid program.
11    (g) A violation of this Section by a pharmacy benefit
12manager constitutes an unfair or deceptive act or practice in
13the business of insurance under Section 424.
14    (h) A provision that violates subsection (f) in a contract
15between a pharmacy benefit manager or a third-party payer and
16a 340B entity that is entered into, amended, or renewed after
17July 1, 2022 shall be void and unenforceable.
18    (i)(1) A pharmacy benefit manager may not retaliate
19against a pharmacist or pharmacy for disclosing information in
20a court, in an administrative hearing, before a legislative
21commission or committee, or in any other proceeding, if the
22pharmacist or pharmacy has reasonable cause to believe that
23the disclosed information is evidence of a violation of a
24State or federal law, rule, or regulation.
25    (2) A pharmacy benefit manager may not retaliate against a
26pharmacist or pharmacy for disclosing information to a

 

 

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1government or law enforcement agency, if the pharmacist or
2pharmacy has reasonable cause to believe that the disclosed
3information is evidence of a violation of a State or federal
4law, rule, or regulation.
5    (3) A pharmacist or pharmacy shall make commercially
6reasonable efforts to limit the disclosure of confidential and
7proprietary information.
8    (4) Retaliatory actions against a pharmacy or pharmacist
9include cancellation of, restriction of, or refusal to renew
10or offer a contract to a pharmacy solely because the pharmacy
11or pharmacist has:
12        (A) made disclosures of information that the
13    pharmacist or pharmacy has reasonable cause to believe is
14    evidence of a violation of a State or federal law, rule, or
15    regulation;
16        (B) filed complaints with the plan or pharmacy benefit
17    manager; or
18        (C) filed complaints against the plan or pharmacy
19    benefit manager with the Department.
20    (j) This Section applies to contracts entered into or
21renewed on or after July 1, 2022, except that subsection (g-5)
22applies to contracts entered into or renewed on or after
23January 1, 2026.
24    (k) This Section applies to any group or individual policy
25of accident and health insurance or managed care plan that
26provides coverage for prescription drugs and that is amended,

 

 

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1delivered, issued, or renewed on or after July 1, 2020.
2(Source: P.A. 102-778, eff. 7-1-22; 103-154, eff. 6-30-23;
3103-453, eff. 8-4-23.)
 
4    Section 15. The Pharmacy Practice Act is amended by
5changing Section 19.5 as follows:
 
6    (225 ILCS 85/19.5)
7    (Section scheduled to be repealed on January 1, 2028)
8    Sec. 19.5. Biological products.
9    (a) For the purposes of this Section:
10    "Biological product" has the meaning given to that term in
1142 U.S.C. 262.
12    "Interchangeable biological product" means a biological
13product that the United States Food and Drug Administration:
14        (1) has (A) licensed and (B) determined it to meet the
15    standards for interchangeability pursuant to 42 U.S.C.
16    262(k)(4); or
17        (2) has determined is therapeutically equivalent as
18    set forth in the latest edition of or supplement to the
19    United States Food and Drug Administration's Approved Drug
20    Products with Therapeutic Equivalence Evaluations (Orange
21    Book).
22    (b) A pharmacist may substitute a an interchangeable
23biological product for a prescribed biological product only if
24all of the following conditions in this subsection (b) are

 

 

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1met:
2        (1) the product being considered for substitution is
3    either the reference product or a product approved by the
4    United States Food and Drug Administration as a biosimilar
5    of the prescribed biological product; the substituted
6    product has been determined by the United States Food and
7    Drug Administration to be interchangeable, as defined in
8    subsection (a) of this Section, with the prescribed
9    biological product;
10        (2) the prescribing physician does not designate
11    orally, in writing, or electronically that substitution is
12    prohibited in a manner consistent with Section 25 of this
13    Act; and
14        (3) the pharmacy informs the patient of the
15    substitution.
16    (c) Within 5 business days following the dispensing of a
17biological product, the dispensing pharmacist or the
18pharmacist's designee shall make an entry of the specific
19product provided to the patient, including the name of the
20product and the manufacturer. The communication shall be
21conveyed by making an entry that can be electronically
22accessed by the prescriber through:
23        (1) an interoperable electronic medical records
24    system;
25        (2) an electronic prescribing technology;
26        (3) a pharmacy benefit management system; or

 

 

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1        (4) a pharmacy record.
2    Entry into an electronic records system as described in
3this subsection (c) is presumed to provide notice in
4accordance with this subsection (c). Otherwise, the pharmacist
5shall communicate the biological product dispensed to the
6prescriber using facsimile, telephone, electronic
7transmission, or other prevailing means, except that
8communication shall not be required if where: (A) there is no
9United States Food and Drug Administration-approved
10interchangeable biological product for the product prescribed;
11or (B) a refill prescription is not changed from the product
12dispensed on the prior filling of the prescription.
13    (d) The pharmacy shall retain a record of the biological
14product dispensed for a period of 5 years.
15    (e) (Blank). The Department shall maintain a link on its
16Internet website to the current list of all biological
17products determined by the United States Food and Drug
18Administration to be interchangeable with a specific
19biological product.
20    (f) The Department may adopt rules for compliance with
21this Section.
22(Source: P.A. 99-200, eff. 1-1-16.)