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1 | AN ACT concerning regulation. | |||||||||||||||||||
2 | Be it enacted by the People of the State of Illinois, | |||||||||||||||||||
3 | represented in the General Assembly: | |||||||||||||||||||
4 | Section 5. The Illinois Insurance Code is amended by | |||||||||||||||||||
5 | changing Section 513b1 and by adding Section 513b1.5 as | |||||||||||||||||||
6 | follows: | |||||||||||||||||||
7 | (215 ILCS 5/513b1) | |||||||||||||||||||
8 | Sec. 513b1. Pharmacy benefit manager contracts. | |||||||||||||||||||
9 | (a) As used in this Section: | |||||||||||||||||||
10 | "340B drug discount program" means the program established | |||||||||||||||||||
11 | under Section 340B of the federal Public Health Service Act, | |||||||||||||||||||
12 | 42 U.S.C. 256b. | |||||||||||||||||||
13 | "340B entity" means a covered entity as defined in 42 | |||||||||||||||||||
14 | U.S.C. 256b(a)(4) authorized to participate in the 340B drug | |||||||||||||||||||
15 | discount program. | |||||||||||||||||||
16 | "340B pharmacy" means any pharmacy used to dispense 340B | |||||||||||||||||||
17 | drugs for a covered entity, whether entity-owned or external. | |||||||||||||||||||
18 | "Biological product" has the meaning ascribed to that term | |||||||||||||||||||
19 | in Section 19.5 of the Pharmacy Practice Act. | |||||||||||||||||||
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 |
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1 | which a maximum allowable cost has been established by a | ||||||
2 | pharmacy benefit manager. | ||||||
3 | "Pharmacy benefit manager" means a person, business, or | ||||||
4 | entity, including a wholly or partially owned or controlled | ||||||
5 | subsidiary of a pharmacy benefit manager, that provides claims | ||||||
6 | processing services or other prescription drug or device | ||||||
7 | services, or both, for health benefit plans. | ||||||
8 | "Retail price" means the price an individual without | ||||||
9 | prescription drug coverage would pay at a retail pharmacy, not | ||||||
10 | including a pharmacist dispensing fee. | ||||||
11 | "Steer" includes, but is not limited to: | ||||||
12 | (1) requiring a covered individual to use only a | ||||||
13 | pharmacy, including a mail-order pharmacy, in which the | ||||||
14 | pharmacy benefit manager maintains an ownership interest | ||||||
15 | or control; | ||||||
16 | (2) offering or implementing a plan design that | ||||||
17 | encourages a covered individual to use a pharmacy in which | ||||||
18 | the pharmacy benefit manager maintains an ownership | ||||||
19 | interest or control, if such plan design increases costs | ||||||
20 | for the covered individual, including requiring a covered | ||||||
21 | individual to pay full costs for a prescription if the | ||||||
22 | covered individual chooses not to use a pharmacy owned or | ||||||
23 | controlled by the pharmacy benefit manager; | ||||||
24 | (3) reimbursing a pharmacy or pharmacist for a | ||||||
25 | pharmaceutical product or pharmacist service in an amount | ||||||
26 | less than the amount that the pharmacy benefit manager |
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1 | reimburses itself or an affiliate for providing the same | ||||||
2 | product or services, unless the pharmacy or pharmacist | ||||||
3 | contractually agrees to a lower reimbursement amount; or | ||||||
4 | (4) any other actions determined by the Department by | ||||||
5 | rule. | ||||||
6 | "Third-party payer" means any entity that pays for | ||||||
7 | prescription drugs on behalf of a patient other than a health | ||||||
8 | care provider or sponsor of a plan subject to regulation under | ||||||
9 | Medicare Part D, 42 U.S.C. 1395w-101 et seq. | ||||||
10 | (b) A contract between a health insurer and a pharmacy | ||||||
11 | benefit manager must require that the pharmacy benefit | ||||||
12 | manager: | ||||||
13 | (1) Update maximum allowable cost pricing information | ||||||
14 | at least every 7 calendar days. | ||||||
15 | (2) Maintain a process that will, in a timely manner, | ||||||
16 | eliminate drugs from maximum allowable cost lists or | ||||||
17 | modify drug prices to remain consistent with changes in | ||||||
18 | pricing data used in formulating maximum allowable cost | ||||||
19 | prices and product availability. | ||||||
20 | (3) Provide access to its maximum allowable cost list | ||||||
21 | to each pharmacy or pharmacy services administrative | ||||||
22 | organization subject to the maximum allowable cost list. | ||||||
23 | Access may include a real-time pharmacy website portal to | ||||||
24 | be able to view the maximum allowable cost list. As used in | ||||||
25 | this Section, "pharmacy services administrative | ||||||
26 | organization" means an entity operating within the State |
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1 | that contracts with independent pharmacies to conduct | ||||||
2 | business on their behalf with third-party payers. A | ||||||
3 | pharmacy services administrative organization may provide | ||||||
4 | administrative services to pharmacies and negotiate and | ||||||
5 | enter into contracts with third-party payers or pharmacy | ||||||
6 | benefit managers on behalf of pharmacies. | ||||||
7 | (4) Provide a process by which a contracted pharmacy | ||||||
8 | can appeal the provider's reimbursement for a drug subject | ||||||
9 | to maximum allowable cost pricing. The appeals process | ||||||
10 | must, at a minimum, include the following: | ||||||
11 | (A) A requirement that a contracted pharmacy has | ||||||
12 | 14 calendar days after the applicable fill date to | ||||||
13 | appeal a maximum allowable cost if the reimbursement | ||||||
14 | for the drug is less than the net amount that the | ||||||
15 | network provider paid to the supplier of the drug. | ||||||
16 | (B) A requirement that a pharmacy benefit manager | ||||||
17 | must respond to a challenge within 14 calendar days of | ||||||
18 | the contracted pharmacy making the claim for which the | ||||||
19 | appeal has been submitted. | ||||||
20 | (C) A telephone number and e-mail address or | ||||||
21 | website to network providers, at which the provider | ||||||
22 | can contact the pharmacy benefit manager to process | ||||||
23 | and submit an appeal. | ||||||
24 | (D) A requirement that, if an appeal is denied, | ||||||
25 | the pharmacy benefit manager must provide the reason | ||||||
26 | for the denial and the name and the national drug code |
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1 | number from national or regional wholesalers. | ||||||
2 | (E) A requirement that, if an appeal is sustained, | ||||||
3 | the pharmacy benefit manager must make an adjustment | ||||||
4 | in the drug price effective the date the challenge is | ||||||
5 | resolved and make the adjustment applicable to all | ||||||
6 | similarly situated network pharmacy providers, as | ||||||
7 | determined by the managed care organization or | ||||||
8 | pharmacy benefit manager. | ||||||
9 | (5) Allow a plan sponsor contracting with a pharmacy | ||||||
10 | benefit manager an annual right to audit compliance with | ||||||
11 | the terms of the contract by the pharmacy benefit manager, | ||||||
12 | including, but not limited to, full disclosure of any and | ||||||
13 | all rebate amounts secured, whether product specific or | ||||||
14 | generalized rebates, that were provided to the pharmacy | ||||||
15 | benefit manager by a pharmaceutical manufacturer. | ||||||
16 | (6) Allow a plan sponsor contracting with a pharmacy | ||||||
17 | benefit manager to request that the pharmacy benefit | ||||||
18 | manager disclose the actual amounts paid by the pharmacy | ||||||
19 | benefit manager to the pharmacy. | ||||||
20 | (7) Provide notice to the party contracting with the | ||||||
21 | pharmacy benefit manager of any consideration that the | ||||||
22 | pharmacy benefit manager receives from the manufacturer | ||||||
23 | for dispense as written prescriptions once a generic or | ||||||
24 | biologically similar product becomes available. | ||||||
25 | (c) In order to place a particular prescription drug on a | ||||||
26 | maximum allowable cost list, the pharmacy benefit manager |
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1 | must, at a minimum, ensure that: | ||||||
2 | (1) if the drug is a generically equivalent drug, it | ||||||
3 | is listed as therapeutically equivalent and | ||||||
4 | pharmaceutically equivalent "A" or "B" rated in the United | ||||||
5 | States Food and Drug Administration's most recent version | ||||||
6 | of the "Orange Book" or have an NR or NA rating by | ||||||
7 | Medi-Span, Gold Standard, or a similar rating by a | ||||||
8 | nationally recognized reference; | ||||||
9 | (2) the drug is available for purchase by each | ||||||
10 | pharmacy in the State from national or regional | ||||||
11 | wholesalers operating in Illinois; and | ||||||
12 | (3) the drug is not obsolete. | ||||||
13 | (d) A pharmacy benefit manager is prohibited from limiting | ||||||
14 | a pharmacist's ability to disclose whether the cost-sharing | ||||||
15 | obligation exceeds the retail price for a covered prescription | ||||||
16 | drug, and the availability of a more affordable alternative | ||||||
17 | drug, if one is available in accordance with Section 42 of the | ||||||
18 | Pharmacy Practice Act. | ||||||
19 | (e) A health insurer or pharmacy benefit manager shall not | ||||||
20 | require an insured to make a payment for a prescription drug at | ||||||
21 | the point of sale in an amount that exceeds the lesser of: | ||||||
22 | (1) the applicable cost-sharing amount; or | ||||||
23 | (2) the retail price of the drug in the absence of | ||||||
24 | prescription drug coverage. | ||||||
25 | (f) Unless required by law, a contract between a pharmacy | ||||||
26 | benefit manager or third-party payer and a 340B entity or 340B |
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1 | pharmacy shall not contain any provision that: | ||||||
2 | (1) distinguishes between drugs purchased through the | ||||||
3 | 340B drug discount program and other drugs when | ||||||
4 | determining reimbursement or reimbursement methodologies, | ||||||
5 | or contains otherwise less favorable payment terms or | ||||||
6 | reimbursement methodologies for 340B entities or 340B | ||||||
7 | pharmacies when compared to similarly situated non-340B | ||||||
8 | entities; | ||||||
9 | (2) imposes any fee, chargeback, or rate adjustment | ||||||
10 | that is not similarly imposed on similarly situated | ||||||
11 | pharmacies that are not 340B entities or 340B pharmacies; | ||||||
12 | (3) imposes any fee, chargeback, or rate adjustment | ||||||
13 | that exceeds the fee, chargeback, or rate adjustment that | ||||||
14 | is not similarly imposed on similarly situated pharmacies | ||||||
15 | that are not 340B entities or 340B pharmacies; | ||||||
16 | (4) prevents or interferes with an individual's choice | ||||||
17 | to receive a covered prescription drug from a 340B entity | ||||||
18 | or 340B pharmacy through any legally permissible means, | ||||||
19 | except that nothing in this paragraph shall prohibit the | ||||||
20 | establishment of differing copayments or other | ||||||
21 | cost-sharing amounts within the benefit plan for covered | ||||||
22 | persons who acquire covered prescription drugs from a | ||||||
23 | nonpreferred or nonparticipating provider; | ||||||
24 | (5) excludes a 340B entity or 340B pharmacy from a | ||||||
25 | pharmacy network on any basis that includes consideration | ||||||
26 | of whether the 340B entity or 340B pharmacy participates |
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1 | in the 340B drug discount program; | ||||||
2 | (6) prevents a 340B entity or 340B pharmacy from using | ||||||
3 | a drug purchased under the 340B drug discount program; or | ||||||
4 | (7) any other provision that discriminates against a | ||||||
5 | 340B entity or 340B pharmacy by treating the 340B entity | ||||||
6 | or 340B pharmacy differently than non-340B entities or | ||||||
7 | non-340B pharmacies for any reason relating to the | ||||||
8 | entity's participation in the 340B drug discount program. | ||||||
9 | As used in this subsection, "pharmacy benefit manager" and | ||||||
10 | "third-party payer" do not include pharmacy benefit managers | ||||||
11 | and third-party payers acting on behalf of a Medicaid program. | ||||||
12 | (f-5) A pharmacy benefit manager or an affiliate acting on | ||||||
13 | the pharmacy benefit manager's behalf shall not steer a | ||||||
14 | covered individual. | ||||||
15 | (g) A violation of this Section by a pharmacy benefit | ||||||
16 | manager constitutes an unfair or deceptive act or practice in | ||||||
17 | the business of insurance under Section 424. | ||||||
18 | (h) A provision that violates subsection (f) in a contract | ||||||
19 | between a pharmacy benefit manager or a third-party payer and | ||||||
20 | a 340B entity that is entered into, amended, or renewed after | ||||||
21 | July 1, 2022 shall be void and unenforceable. | ||||||
22 | (i)(1) A pharmacy benefit manager may not retaliate | ||||||
23 | against a pharmacist or pharmacy for disclosing information in | ||||||
24 | a court, in an administrative hearing, before a legislative | ||||||
25 | commission or committee, or in any other proceeding, if the | ||||||
26 | pharmacist or pharmacy has reasonable cause to believe that |
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1 | the disclosed information is evidence of a violation of a | ||||||
2 | State or federal law, rule, or regulation. | ||||||
3 | (2) A pharmacy benefit manager may not retaliate against a | ||||||
4 | pharmacist or pharmacy for disclosing information to a | ||||||
5 | government or law enforcement agency, if the pharmacist or | ||||||
6 | pharmacy has reasonable cause to believe that the disclosed | ||||||
7 | information is evidence of a violation of a State or federal | ||||||
8 | law, rule, or regulation. | ||||||
9 | (3) A pharmacist or pharmacy shall make commercially | ||||||
10 | reasonable efforts to limit the disclosure of confidential and | ||||||
11 | proprietary information. | ||||||
12 | (4) Retaliatory actions against a pharmacy or pharmacist | ||||||
13 | include cancellation of, restriction of, or refusal to renew | ||||||
14 | or offer a contract to a pharmacy solely because the pharmacy | ||||||
15 | or pharmacist has: | ||||||
16 | (A) made disclosures of information that the | ||||||
17 | pharmacist or pharmacy has reasonable cause to believe is | ||||||
18 | evidence of a violation of a State or federal law, rule, or | ||||||
19 | regulation; | ||||||
20 | (B) filed complaints with the plan or pharmacy benefit | ||||||
21 | manager; or | ||||||
22 | (C) filed complaints against the plan or pharmacy | ||||||
23 | benefit manager with the Department. | ||||||
24 | (j) This Section applies to contracts entered into or | ||||||
25 | renewed on or after July 1, 2022. | ||||||
26 | (k) This Section applies to any group or individual policy |
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1 | of accident and health insurance or managed care plan that | ||||||
2 | provides coverage for prescription drugs and that is amended, | ||||||
3 | delivered, issued, or renewed on or after July 1, 2020. | ||||||
4 | (Source: P.A. 102-778, eff. 7-1-22; 103-154, eff. 6-30-23; | ||||||
5 | 103-453, eff. 8-4-23.) | ||||||
6 | Section 99. Effective date. This Act takes effect July 1, | ||||||
7 | 2024. |