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Public Act 103-0453 | ||||
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AN ACT concerning regulation.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 5. The Illinois Insurance Code is amended by | ||||
changing Section 513b1 as follows: | ||||
(215 ILCS 5/513b1) | ||||
Sec. 513b1. Pharmacy benefit manager contracts. | ||||
(a) As used in this Section: | ||||
"340B drug discount program" means the program established
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under Section 340B of the federal Public Health Service Act, | ||||
42 U.S.C. 256b. | ||||
"340B entity" means a covered entity as defined in 42 | ||||
U.S.C. 256b(a)(4) authorized to participate in the 340B drug | ||||
discount program. | ||||
"340B pharmacy" means any pharmacy used to dispense 340B | ||||
drugs for a covered entity, whether entity-owned or external. | ||||
"Biological product" has the meaning ascribed to that term | ||||
in Section 19.5 of the Pharmacy Practice Act. | ||||
"Maximum allowable cost" means the maximum amount that a | ||||
pharmacy benefit manager will reimburse a pharmacy for the | ||||
cost of a drug. | ||||
"Maximum allowable cost list" means a list of drugs for | ||||
which a maximum allowable cost has been established by a |
pharmacy benefit manager. | ||
"Pharmacy benefit manager" means a person, business, or | ||
entity, including a wholly or partially owned or controlled | ||
subsidiary of a pharmacy benefit manager, that provides claims | ||
processing services or other prescription drug or device | ||
services, or both, for health benefit plans. | ||
"Retail price" means the price an individual without | ||
prescription drug coverage would pay at a retail pharmacy, not | ||
including a pharmacist dispensing fee. | ||
"Third-party payer" means any entity that pays for | ||
prescription drugs on behalf of a patient other than a health | ||
care provider or sponsor of a plan subject to regulation under | ||
Medicare Part D, 42 U.S.C. 1395w-101 , et seq. | ||
(b) A contract between a health insurer and a pharmacy | ||
benefit manager must require that the pharmacy benefit | ||
manager: | ||
(1) Update maximum allowable cost pricing information | ||
at least every 7 calendar days. | ||
(2) Maintain a process that will, in a timely manner, | ||
eliminate drugs from maximum allowable cost lists or | ||
modify drug prices to remain consistent with changes in | ||
pricing data used in formulating maximum allowable cost | ||
prices and product availability. | ||
(3) Provide access to its maximum allowable cost list | ||
to each pharmacy or pharmacy services administrative | ||
organization subject to the maximum allowable cost list. |
Access may include a real-time pharmacy website portal to | ||
be able to view the maximum allowable cost list. As used in | ||
this Section, "pharmacy services administrative | ||
organization" means an entity operating within the State | ||
that contracts with independent pharmacies to conduct | ||
business on their behalf with third-party payers. A | ||
pharmacy services administrative organization may provide | ||
administrative services to pharmacies and negotiate and | ||
enter into contracts with third-party payers or pharmacy | ||
benefit managers on behalf of pharmacies. | ||
(4) Provide a process by which a contracted pharmacy | ||
can appeal the provider's reimbursement for a drug subject | ||
to maximum allowable cost pricing. The appeals process | ||
must, at a minimum, include the following: | ||
(A) A requirement that a contracted pharmacy has | ||
14 calendar days after the applicable fill date to | ||
appeal a maximum allowable cost if the reimbursement | ||
for the drug is less than the net amount that the | ||
network provider paid to the supplier of the drug. | ||
(B) A requirement that a pharmacy benefit manager | ||
must respond to a challenge within 14 calendar days of | ||
the contracted pharmacy making the claim for which the | ||
appeal has been submitted. | ||
(C) A telephone number and e-mail address or | ||
website to network providers, at which the provider | ||
can contact the pharmacy benefit manager to process |
and submit an appeal. | ||
(D) A requirement that, if an appeal is denied, | ||
the pharmacy benefit manager must provide the reason | ||
for the denial and the name and the national drug code | ||
number from national or regional wholesalers. | ||
(E) A requirement that, if an appeal is sustained, | ||
the pharmacy benefit manager must make an adjustment | ||
in the drug price effective the date the challenge is | ||
resolved and make the adjustment applicable to all | ||
similarly situated network pharmacy providers, as | ||
determined by the managed care organization or | ||
pharmacy benefit manager. | ||
(5) Allow a plan sponsor contracting with a pharmacy | ||
benefit manager an annual right to audit compliance with | ||
the terms of the contract by the pharmacy benefit manager, | ||
including, but not limited to, full disclosure of any and | ||
all rebate amounts secured, whether product specific or | ||
generalized rebates, that were provided to the pharmacy | ||
benefit manager by a pharmaceutical manufacturer. | ||
(6) Allow a plan sponsor contracting with a pharmacy | ||
benefit manager to request that the pharmacy benefit | ||
manager disclose the actual amounts paid by the pharmacy | ||
benefit manager to the pharmacy. | ||
(7) Provide notice to the party contracting with the | ||
pharmacy benefit manager of any consideration that the | ||
pharmacy benefit manager receives from the manufacturer |
for dispense as written prescriptions once a generic or | ||
biologically similar product becomes available. | ||
(c) In order to place a particular prescription drug on a | ||
maximum allowable cost list, the pharmacy benefit manager | ||
must, at a minimum, ensure that: | ||
(1) if the drug is a generically equivalent drug, it | ||
is listed as therapeutically equivalent and | ||
pharmaceutically equivalent "A" or "B" rated in the United | ||
States Food and Drug Administration's most recent version | ||
of the "Orange Book" or have an NR or NA rating by | ||
Medi-Span, Gold Standard, or a similar rating by a | ||
nationally recognized reference; | ||
(2) the drug is available for purchase by each | ||
pharmacy in the State from national or regional | ||
wholesalers operating in Illinois; and | ||
(3) the drug is not obsolete. | ||
(d) A pharmacy benefit manager is prohibited from limiting | ||
a pharmacist's ability to disclose whether the cost-sharing | ||
obligation exceeds the retail price for a covered prescription | ||
drug, and the availability of a more affordable alternative | ||
drug, if one is available in accordance with Section 42 of the | ||
Pharmacy Practice Act. | ||
(e) A health insurer or pharmacy benefit manager shall not | ||
require an insured to make a payment for a prescription drug at | ||
the point of sale in an amount that exceeds the lesser of: | ||
(1) the applicable cost-sharing amount; or |
(2) the retail price of the drug in the absence of | ||
prescription drug coverage. | ||
(f) Unless required by law, a contract between a pharmacy | ||
benefit manager or third-party payer and a 340B entity or 340B | ||
pharmacy shall not contain any provision that: | ||
(1) distinguishes between drugs purchased through the | ||
340B drug discount program and other drugs when | ||
determining reimbursement or reimbursement methodologies, | ||
or contains otherwise less favorable payment terms or | ||
reimbursement methodologies for 340B entities or 340B | ||
pharmacies when compared to similarly situated non-340B | ||
entities; | ||
(2) imposes any fee, chargeback, or rate adjustment | ||
that is not similarly imposed on similarly situated | ||
pharmacies that are not 340B entities or 340B pharmacies; | ||
(3) imposes any fee, chargeback, or rate adjustment | ||
that exceeds the fee, chargeback, or rate adjustment that | ||
is not similarly imposed on similarly situated pharmacies | ||
that are not 340B entities or 340B pharmacies; | ||
(4) prevents or interferes with an individual's choice | ||
to receive a covered prescription drug from a 340B entity | ||
or 340B pharmacy through any legally permissible means, | ||
except that nothing in this paragraph shall prohibit the | ||
establishment of differing copayments or other | ||
cost-sharing amounts within the benefit plan for covered | ||
persons who acquire covered prescription drugs from a |
nonpreferred or nonparticipating provider; | ||
(5) excludes a 340B entity or 340B pharmacy from a | ||
pharmacy network on any basis that includes consideration | ||
of whether the 340B entity or 340B pharmacy participates | ||
in the 340B drug discount program; | ||
(6) prevents a 340B entity or 340B pharmacy from using | ||
a drug purchased under the 340B drug discount program; or | ||
(7) any other provision that discriminates against a | ||
340B entity or 340B pharmacy by treating the 340B entity | ||
or 340B pharmacy differently than non-340B entities or | ||
non-340B pharmacies for any reason relating to the | ||
entity's participation in the 340B drug discount program. | ||
As used in this subsection, "pharmacy benefit manager" and | ||
"third-party payer" do not include pharmacy benefit managers | ||
and third-party payers acting on behalf of a Medicaid program. | ||
(g) A violation of this Section by a pharmacy benefit | ||
manager constitutes an unfair or deceptive act or practice in | ||
the business of insurance under Section 424. | ||
(h) A provision that violates subsection (f) in a contract | ||
between a pharmacy benefit manager or a third-party payer and | ||
a 340B entity that is entered into, amended, or renewed after | ||
July 1, 2022 shall be void and unenforceable. | ||
(i)(1) A pharmacy benefit manager may not retaliate | ||
against a pharmacist or pharmacy for disclosing information in | ||
a court, in an administrative hearing, before a legislative | ||
commission or committee, or in any other proceeding, if the |
pharmacist or pharmacy has reasonable cause to believe that | ||
the disclosed information is evidence of a violation of a | ||
State or federal law, rule, or regulation. | ||
(2) A pharmacy benefit manager may not retaliate against a | ||
pharmacist or pharmacy for disclosing information to a | ||
government or law enforcement agency, if the pharmacist or | ||
pharmacy has reasonable cause to believe that the disclosed | ||
information is evidence of a violation of a State or federal | ||
law, rule, or regulation. | ||
(3) A pharmacist or pharmacy shall make commercially | ||
reasonable efforts to limit the disclosure of confidential and | ||
proprietary information. | ||
(4) Retaliatory actions against a pharmacy or pharmacist | ||
include cancellation of, restriction of, or refusal to renew | ||
or offer a contract to a pharmacy solely because the pharmacy | ||
or pharmacist has: | ||
(A) made disclosures of information that the | ||
pharmacist or pharmacy has reasonable cause to believe is | ||
evidence of a violation of a State or federal law, rule, or | ||
regulation; | ||
(B) filed complaints with the plan or pharmacy benefit | ||
manager; or | ||
(C) filed complaints against the plan or pharmacy | ||
benefit manager with the Department. | ||
(j) (i) This Section applies to contracts entered into or | ||
renewed on or after July 1, 2022. |
(k) (j) This Section applies to any group or individual | ||
policy of accident and health insurance or managed care plan | ||
that provides coverage for prescription drugs and that is | ||
amended, delivered, issued, or renewed on or after July 1, | ||
2020.
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(Source: P.A. 101-452, eff. 1-1-20; 102-778, eff. 7-1-22; | ||
revised 8-19-22.)
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Section 99. Effective date. This Act takes effect July 1, | ||
2023. |