|
| | 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. |
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| | A BILL FOR |
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| | HB3794 | | LRB104 10437 BAB 20512 b |
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1 | | AN ACT concerning prescription drugs. |
2 | | Be it enacted by the People of the State of Illinois, |
3 | | represented in the General Assembly: |
4 | | Section 5. The Freedom of Information Act is amended by |
5 | | changing Section 7.5 as follows: |
6 | | (5 ILCS 140/7.5) |
7 | | Sec. 7.5. Statutory exemptions. To the extent provided for |
8 | | by the statutes referenced below, the following shall be |
9 | | exempt 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 |
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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 |
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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 |
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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. |
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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; |
19 | | 102-292, eff. 1-1-22; 102-520, eff. 8-20-21; 102-559, eff. |
20 | | 8-20-21; 102-813, eff. 5-13-22; 102-946, eff. 7-1-22; |
21 | | 102-1042, eff. 6-3-22; 102-1116, eff. 1-10-23; 103-8, eff. |
22 | | 6-7-23; 103-34, eff. 6-9-23; 103-142, eff. 1-1-24; 103-372, |
23 | | eff. 1-1-24; 103-472, eff. 8-1-24; 103-508, eff. 8-4-23; |
24 | | 103-580, eff. 12-8-23; 103-592, eff. 6-7-24; 103-605, eff. |
25 | | 7-1-24; 103-636, eff. 7-1-24; 103-724, eff. 1-1-25; 103-786, |
26 | | eff. 8-7-24; 103-859, eff. 8-9-24; 103-991, eff. 8-9-24; |
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1 | | 103-1049, eff. 8-9-24; revised 11-26-24.) |
2 | | Section 10. The Illinois Insurance Code is amended by |
3 | | changing 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 |
8 | | under Section 340B of the federal Public Health Service Act, |
9 | | 42 U.S.C. 256b. |
10 | | "340B entity" means a covered entity as defined in 42 |
11 | | U.S.C. 256b(a)(4) authorized to participate in the 340B drug |
12 | | discount program. |
13 | | "340B pharmacy" means any pharmacy used to dispense 340B |
14 | | drugs for a covered entity, whether entity-owned or external. |
15 | | "Biological product" has the meaning ascribed to that term |
16 | | in Section 19.5 of the Pharmacy Practice Act. |
17 | | "Defined cost sharing" means a deductible payment or |
18 | | coinsurance amount imposed on an enrollee for a covered |
19 | | prescription drug under the enrollee's health benefit plan. |
20 | | "Maximum allowable cost" means the maximum amount that a |
21 | | pharmacy benefit manager will reimburse a pharmacy for the |
22 | | cost of a drug. |
23 | | "Maximum allowable cost list" means a list of drugs for |
24 | | which a maximum allowable cost has been established by a |
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1 | | pharmacy benefit manager. |
2 | | "Pharmacy benefit manager" means a person, business, or |
3 | | entity, including a wholly or partially owned or controlled |
4 | | subsidiary of a pharmacy benefit manager, that provides claims |
5 | | processing services or other prescription drug or device |
6 | | services, or both, for health benefit plans. |
7 | | "Price protection rebate" means a negotiated price |
8 | | concession that accrues directly or indirectly to a health |
9 | | insurer, or other party on behalf of the health insurer, if |
10 | | there is an increase in the wholesale acquisition cost of a |
11 | | prescription 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 |
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1 | | prescription drug coverage would pay at a retail pharmacy, not |
2 | | including a pharmacist dispensing fee. |
3 | | "Third-party payer" means any entity that pays for |
4 | | prescription drugs on behalf of a patient other than a health |
5 | | care provider or sponsor of a plan subject to regulation under |
6 | | Medicare Part D, 42 U.S.C. 1395w-101 et seq. |
7 | | (b) A contract between a health insurer and a pharmacy |
8 | | benefit manager must require that the pharmacy benefit |
9 | | manager: |
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 |
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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 |
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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 |
23 | | maximum allowable cost list, the pharmacy benefit manager |
24 | | must, at a minimum, ensure that: |
25 | | (1) if the drug is a generically equivalent drug, it |
26 | | is listed as therapeutically equivalent and |
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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 |
11 | | a pharmacist's ability to disclose whether the cost-sharing |
12 | | obligation exceeds the retail price for a covered prescription |
13 | | drug, and the availability of a more affordable alternative |
14 | | drug, if one is available in accordance with Section 42 of the |
15 | | Pharmacy Practice Act. |
16 | | (e) A health insurer or pharmacy benefit manager shall not |
17 | | require an insured to make a payment for a prescription drug at |
18 | | the 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 |
23 | | benefit manager or third-party payer and a 340B entity or 340B |
24 | | pharmacy shall not contain any provision that: |
25 | | (1) distinguishes between drugs purchased through the |
26 | | 340B drug discount program and other drugs when |
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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 |
7 | | each prescription drug shall be calculated at the point of |
8 | | sale based on a price that is reduced by an amount equal to at |
9 | | least 80% of all rebates received or to be received in |
10 | | connection with the dispensing or administration of the |
11 | | prescription drug. |
12 | | In complying with this Section, a health insurer or its |
13 | | agents shall not publish or otherwise reveal information |
14 | | regarding the actual amount of rebates a health insurer |
15 | | receives on a product or therapeutic class of products, |
16 | | manufacturer-specific basis, or pharmacy-specific basis. The |
17 | | information described in this subsection is: (i) considered |
18 | | protected as a trade secret; (ii) considered proprietary and |
19 | | confidential; (iii) not subject to disclosure under the |
20 | | federal Freedom of Information Act or the Freedom of |
21 | | Information Act; and (iv) not to be disclosed directly, |
22 | | indirectly, or in a manner that would either allow for the |
23 | | identification of an individual product, therapeutic class of |
24 | | products, or manufacturer or have the potential to compromise |
25 | | the financial, competitive, or proprietary nature of the |
26 | | information. A health insurer shall impose the confidentiality |
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1 | | protections of this subsection on any vendor or other third |
2 | | party that performs health care or administrative services on |
3 | | behalf of the health insurer that may receive or have access to |
4 | | rebate information. |
5 | | Nothing in this subsection precludes a pharmacy benefit |
6 | | manager or insurer from reducing an insured's cost sharing by |
7 | | an 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 |
10 | | and third-party payers acting on behalf of a Medicaid program. |
11 | | (g) A violation of this Section by a pharmacy benefit |
12 | | manager constitutes an unfair or deceptive act or practice in |
13 | | the business of insurance under Section 424. |
14 | | (h) A provision that violates subsection (f) in a contract |
15 | | between a pharmacy benefit manager or a third-party payer and |
16 | | a 340B entity that is entered into, amended, or renewed after |
17 | | July 1, 2022 shall be void and unenforceable. |
18 | | (i)(1) A pharmacy benefit manager may not retaliate |
19 | | against a pharmacist or pharmacy for disclosing information in |
20 | | a court, in an administrative hearing, before a legislative |
21 | | commission or committee, or in any other proceeding, if the |
22 | | pharmacist or pharmacy has reasonable cause to believe that |
23 | | the disclosed information is evidence of a violation of a |
24 | | State or federal law, rule, or regulation. |
25 | | (2) A pharmacy benefit manager may not retaliate against a |
26 | | pharmacist or pharmacy for disclosing information to a |
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1 | | government or law enforcement agency, if the pharmacist or |
2 | | pharmacy has reasonable cause to believe that the disclosed |
3 | | information is evidence of a violation of a State or federal |
4 | | law, rule, or regulation. |
5 | | (3) A pharmacist or pharmacy shall make commercially |
6 | | reasonable efforts to limit the disclosure of confidential and |
7 | | proprietary information. |
8 | | (4) Retaliatory actions against a pharmacy or pharmacist |
9 | | include cancellation of, restriction of, or refusal to renew |
10 | | or offer a contract to a pharmacy solely because the pharmacy |
11 | | or 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 |
21 | | renewed on or after July 1, 2022 , except that subsection (g-5) |
22 | | applies to contracts entered into or renewed on or after |
23 | | January 1, 2026 . |
24 | | (k) This Section applies to any group or individual policy |
25 | | of accident and health insurance or managed care plan that |
26 | | provides coverage for prescription drugs and that is amended, |
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1 | | delivered, 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; |
3 | | 103-453, eff. 8-4-23.) |
4 | | Section 15. The Pharmacy Practice Act is amended by |
5 | | changing 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 |
11 | | 42 U.S.C. 262. |
12 | | "Interchangeable biological product" means a biological |
13 | | product 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 |
23 | | biological product for a prescribed biological product only if |
24 | | all of the following conditions in this subsection (b) are |
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1 | | met: |
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 |
17 | | biological product, the dispensing pharmacist or the |
18 | | pharmacist's designee shall make an entry of the specific |
19 | | product provided to the patient, including the name of the |
20 | | product and the manufacturer. The communication shall be |
21 | | conveyed by making an entry that can be electronically |
22 | | accessed 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 |
3 | | this subsection (c) is presumed to provide notice in |
4 | | accordance with this subsection (c). Otherwise, the pharmacist |
5 | | shall communicate the biological product dispensed to the |
6 | | prescriber using facsimile, telephone, electronic |
7 | | transmission, or other prevailing means, except that |
8 | | communication shall not be required if where: (A) there is no |
9 | | United States Food and Drug Administration-approved |
10 | | interchangeable biological product for the product prescribed; |
11 | | or (B) a refill prescription is not changed from the product |
12 | | dispensed on the prior filling of the prescription. |
13 | | (d) The pharmacy shall retain a record of the biological |
14 | | product dispensed for a period of 5 years. |
15 | | (e) (Blank). The Department shall maintain a link on its |
16 | | Internet website to the current list of all biological |
17 | | products determined by the United States Food and Drug |
18 | | Administration to be interchangeable with a specific |
19 | | biological product. |
20 | | (f) The Department may adopt rules for compliance with |
21 | | this Section. |
22 | | (Source: P.A. 99-200, eff. 1-1-16 .) |