Bill Text: IL HB2371 | 2025-2026 | 104th General Assembly | Enrolled
Bill Title: Creates the Patient Access to Pharmacy Protection Act. Provides that no person, including a pharmaceutical manufacturer, may deny, restrict, prohibit, condition, or otherwise interfere with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B covered entity or a 340B contract pharmacy authorized to receive 340B drugs on behalf of the 340B covered entity unless the receipt is prohibited by federal law; impose any restriction on the ability of a 340B covered entity to contract with or designate a 340B contract pharmacy; or require or compel a 340B covered entity or 340B contract pharmacy to perform the specified actions. Provides that each individual transaction of 340B drugs that is subject to a prohibited act, as specified, shall constitute a separate violation of the Act. Sets forth provisions concerning reporting requirements for a 340B covered entity and the Department of Healthcare and Family Services; 340B prescription drug applicability; preventing duplication of 340B discounts; enforcement of the Act by the Attorney General; penalties; and preemption. Effective immediately.
Sponsorship: Moderate Partisan Bill (Democrat 28-4)
Status: (Passed) 2026-08-07 - Public Act . . . . . . . . . 104-0758 [HB2371 Detail]
Download: Illinois-2025-HB2371-Enrolled.html
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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 1. Short title. This Act may be cited as the | ||||||
| 5 | Patient Access to Pharmacy Protection Act. | ||||||
| 6 | Section 5. Findings. The General Assembly finds that: | ||||||
| 7 | (1) It is within the traditional authority of the State to | ||||||
| 8 | regulate the acquisition and delivery of drugs to pharmacies | ||||||
| 9 | and providers. | ||||||
| 10 | (2) The federal 340B statute is silent on distribution of | ||||||
| 11 | 340B-acquired drugs to 340B covered entities and their | ||||||
| 12 | contract pharmacy partners. | ||||||
| 13 | (3) The State's compelling interest in preserving and | ||||||
| 14 | improving access to health care services requires it to ensure | ||||||
| 15 | that 340B covered entities continue to be allowed to contract | ||||||
| 16 | with pharmacies to receive 340B drugs and dispense them to the | ||||||
| 17 | patients of 340B covered entities in accordance with federal | ||||||
| 18 | law. | ||||||
| 19 | (4) Addressing accessibility of these life-saving | ||||||
| 20 | medications is a matter of health, safety, and welfare for the | ||||||
| 21 | people of the State of Illinois. | ||||||
| 22 | Section 10. Definitions. As used in this Act: | ||||||
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| 1 | "340B contract pharmacy" means any pharmacy that is under | ||||||
| 2 | contract with a 340B covered entity to dispense 340B drugs on | ||||||
| 3 | behalf of the 340B covered entity and is either (i) located in | ||||||
| 4 | Illinois and qualifies as a pharmacy under Section 3 of the | ||||||
| 5 | Pharmacy Practice Act; or (ii) is located in a state, | ||||||
| 6 | commonwealth, or territory of the United States, other than | ||||||
| 7 | Illinois, and dispenses 340B drugs on behalf of the 340B | ||||||
| 8 | covered entity. | ||||||
| 9 | "340B covered entity" means an entity in Illinois that | ||||||
| 10 | qualifies as a covered entity under Section 340B of the | ||||||
| 11 | federal Public Health Service Act, 42 U.S.C. 256b(a)(4). | ||||||
| 12 | "340B drug" means a drug that has been subject to any offer | ||||||
| 13 | for reduced prices by a manufacturer pursuant to 42 U.S.C. | ||||||
| 14 | 256b and is purchased by a 340B covered entity. | ||||||
| 15 | "340B drug discount program" means the program established | ||||||
| 16 | under Section 340B of the federal Public Health Service Act, | ||||||
| 17 | 42 U.S.C. 256b. | ||||||
| 18 | "340B grantee" means an entity in Illinois that qualifies | ||||||
| 19 | as a covered entity under subparagraphs (A)�(K) of paragraph | ||||||
| 20 | (4) of subsection (a) of Section 340B of the federal Public | ||||||
| 21 | Health Service Act, 42 U.S.C. 256b(a)(4)(A)-(K). | ||||||
| 22 | "Critical Access Hospital" has the meaning given to that | ||||||
| 23 | term in paragraph (4) of subsection (b) of Section 5-5e of the | ||||||
| 24 | Illinois Public Aid Code. | ||||||
| 25 | "Hospital" means a hospital licensed under the Hospital | ||||||
| 26 | Licensing Act or University of Illinois Hospital Act. | ||||||
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| 1 | "Manufacturer" or "Pharmaceutical Manufacturer" has the | ||||||
| 2 | meaning given to the term "manufacturer" in the Wholesale Drug | ||||||
| 3 | Distribution Licensing Act. | ||||||
| 4 | "Person" includes a natural person, partnership, | ||||||
| 5 | association, corporation, or any other legal business entity. | ||||||
| 6 | "Person" does not include any federal or State government | ||||||
| 7 | entity or body. | ||||||
| 8 | "Safety-Net Hospital" has the meaning given to that term | ||||||
| 9 | in Section 5-5e.1 of the Illinois Public Aid Code. | ||||||
| 10 | Section 15. Protection of patient access to pharmacy. | ||||||
| 11 | (a) No person, including a pharmaceutical manufacturer, | ||||||
| 12 | may deny, restrict, prohibit, condition, or otherwise | ||||||
| 13 | interfere with, either directly or indirectly, the acquisition | ||||||
| 14 | of a 340B drug by, or delivery of a 340B drug to, a 340B | ||||||
| 15 | covered entity or a 340B contract pharmacy authorized to | ||||||
| 16 | receive 340B drugs on behalf of the 340B covered entity unless | ||||||
| 17 | the receipt is prohibited by federal law. | ||||||
| 18 | (b) No person, including a pharmaceutical manufacturer, | ||||||
| 19 | may impose any restriction on the ability of a 340B covered | ||||||
| 20 | entity to contract with or designate a 340B contract pharmacy, | ||||||
| 21 | including restrictions relating to the number, location, | ||||||
| 22 | ownership, or type of 340B contract pharmacy. | ||||||
| 23 | (c) No person, including a pharmaceutical manufacturer, | ||||||
| 24 | may require or compel a 340B covered entity or 340B contract | ||||||
| 25 | pharmacy to: | ||||||
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| 1 | (1) submit or otherwise provide ingredient cost or | ||||||
| 2 | pricing data pertinent to 340B drugs unless required by | ||||||
| 3 | State or federal law; | ||||||
| 4 | (2) institute requirements in any way relating to how | ||||||
| 5 | a 340B covered entity manages its inventory of 340B drugs | ||||||
| 6 | that are not required by a State or federal agency, | ||||||
| 7 | including requirements relating to the frequency or scope | ||||||
| 8 | of audits of inventory management systems of a 340B | ||||||
| 9 | covered entity or a 340B contract pharmacy; or | ||||||
| 10 | (3) submit data or information that is not required by | ||||||
| 11 | a State or federal law as a condition for a 340B covered | ||||||
| 12 | entity, its 340B contract pharmacy, or a location | ||||||
| 13 | otherwise authorized by a 340B covered entity to receive | ||||||
| 14 | 340B drugs. | ||||||
| 15 | (d) Each individual transaction, as defined in 21 U.S.C. | ||||||
| 16 | 360eee-24, of 340B drugs that is subject to a prohibited act in | ||||||
| 17 | subsections (a) and (b) shall constitute a separate violation | ||||||
| 18 | of this Act. | ||||||
| 19 | Section 20. Reporting. On or before August 1, 2026 and | ||||||
| 20 | each August 1 thereafter, a 340B covered entity shall submit a | ||||||
| 21 | report to the General Assembly pursuant to this Section. For | ||||||
| 22 | the purposes of this Section, the following covered entities | ||||||
| 23 | are exempt until January 1, 2029 and will report on or before | ||||||
| 24 | August 1, 2029 and each August 1 thereafter: hospitals with | ||||||
| 25 | fewer than 100 licensed beds, Critical Access Hospitals, | ||||||
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| 1 | Safety-Net Hospitals, and 340B grantees. The report must | ||||||
| 2 | include all of the following for the 340B covered entity's | ||||||
| 3 | 340B program: | ||||||
| 4 | (1) the name of the 340B covered entity submitting the | ||||||
| 5 | report; | ||||||
| 6 | (2) a copy of the 340B covered entity's annual 340B | ||||||
| 7 | program recertification; | ||||||
| 8 | (3) whether a community benefits plan report is | ||||||
| 9 | required under Section 20 of the Community Benefits Act | ||||||
| 10 | and, if so, a copy of the 340B covered entity's community | ||||||
| 11 | benefits plan report, including a description of the | ||||||
| 12 | amount of charity care provided by the 340B covered | ||||||
| 13 | entity; | ||||||
| 14 | (4) the aggregate acquisition cost for prescription | ||||||
| 15 | drugs obtained under the 340B program and dispensed or | ||||||
| 16 | administered to patients; | ||||||
| 17 | (5) the aggregate payment amount received for all | ||||||
| 18 | drugs obtained under the 340B program and dispensed or | ||||||
| 19 | administered to patients; | ||||||
| 20 | (6) the number of claims for prescription drugs | ||||||
| 21 | received under the 340B program; | ||||||
| 22 | (7) the percentage of the 340B covered entity's claims | ||||||
| 23 | that were for prescription drugs obtained under the 340B | ||||||
| 24 | program; | ||||||
| 25 | (8) a description of any adverse 340B program audits | ||||||
| 26 | within the preceding 12 months; and | ||||||
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| 1 | (9) a description of the impact of the 340B program on | ||||||
| 2 | the patients and the community served by the 340B covered | ||||||
| 3 | entity. | ||||||
| 4 | Section 25. Medicaid study. | ||||||
| 5 | (a) By January 1, 2028, the Department of Healthcare and | ||||||
| 6 | Family Services shall report to the General Assembly on the | ||||||
| 7 | following for the total aggregated covered outpatient drug | ||||||
| 8 | units dispensed or administered in this State for the prior | ||||||
| 9 | calendar year in connection with the medical assistance | ||||||
| 10 | program under the Illinois Public Aid Code, categorized by (i) | ||||||
| 11 | fee-for-service and (ii) each managed care plan: | ||||||
| 12 | (1) the number of dispensed or administered covered | ||||||
| 13 | outpatient drug units; | ||||||
| 14 | (2) the number of dispensed or administered covered | ||||||
| 15 | outpatient drug units that were subject to a rebate under | ||||||
| 16 | 42 U.S.C. 1396r-8; and | ||||||
| 17 | (3) a reasonable estimate of net costs or savings to | ||||||
| 18 | the State's medical assistance program due to 340B covered | ||||||
| 19 | entity purchases of covered outpatient drug units at 340B | ||||||
| 20 | pricing. | ||||||
| 21 | (b) To the extent the Department of Healthcare and Family | ||||||
| 22 | Services lacks information to provide a data element required | ||||||
| 23 | under subsection (a), it shall provide a reasonable estimate | ||||||
| 24 | based on all available information and an explanation of the | ||||||
| 25 | information that it lacks. | ||||||
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| 1 | Section 30. 340B prescription drug applicability. Each | ||||||
| 2 | 340B covered entity shall dispense or administer 340B drugs | ||||||
| 3 | only when in connection with an outpatient health care service | ||||||
| 4 | received by the patient within the last 18 months. | ||||||
| 5 | Section 35. Preventing duplication of 340B discounts. Each | ||||||
| 6 | 340B covered entity shall develop and maintain a policy that | ||||||
| 7 | ensures it is not placing an order for a 340B drug to replenish | ||||||
| 8 | a prior pharmacy dispense if any other 340B covered entity | ||||||
| 9 | will place an order for a 340B drug to replenish the same prior | ||||||
| 10 | pharmacy dispense. The policy shall also include a process to | ||||||
| 11 | reimburse a manufacturer for any duplicate 340B discount the | ||||||
| 12 | covered entity receives. The policy shall be filed annually | ||||||
| 13 | with the General Assembly. | ||||||
| 14 | Section 40. Enforcement. | ||||||
| 15 | (a) The Attorney General is authorized to enforce this Act | ||||||
| 16 | under its general authority under the Attorney General Act. | ||||||
| 17 | (b) Upon finding a violation of Section 15 of this Act, a | ||||||
| 18 | court may order: | ||||||
| 19 | (1) temporary, preliminary, or permanent injunctive | ||||||
| 20 | relief for any act, policy, or practice that violates this | ||||||
| 21 | Act; | ||||||
| 22 | (2) money damages to be paid to the 340B covered | ||||||
| 23 | entity as a result of the violation of this Act; | ||||||
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| 1 | (3) the assessment of a civil penalty of up to $1,000 | ||||||
| 2 | for each violation of Section 15; or | ||||||
| 3 | (4) any other relief. | ||||||
| 4 | Section 45. Preemption. | ||||||
| 5 | (a) Nothing in this Act shall be construed or applied to be | ||||||
| 6 | less restrictive than federal law for a person regulated by | ||||||
| 7 | this Act. | ||||||
| 8 | (b) Nothing in this Act shall be construed or applied in a | ||||||
| 9 | manner that would conflict with: | ||||||
| 10 | (1) applicable federal law; or | ||||||
| 11 | (2) other laws of this State if the State law is | ||||||
| 12 | compatible with applicable federal law. | ||||||
| 13 | (c) Limited distribution of a drug required under 21 | ||||||
| 14 | U.S.C. 355-1 may not to be construed as a violation of this | ||||||
| 15 | Act. | ||||||
| 16 | Section 97. Severability. If any provision of this Act or | ||||||
| 17 | its application to any person or circumstance is held invalid, | ||||||
| 18 | the invalidity of that provision or application does not | ||||||
| 19 | affect other provisions or applications of this Act that can | ||||||
| 20 | be given effect without the invalid provision or application. | ||||||
| 21 | Each paragraph defining "340B contract pharmacy" in Section 10 | ||||||
| 22 | is severable. | ||||||
| 23 | Section 99. Effective date. This Act takes effect upon | ||||||
| 24 | becoming law. | ||||||
