410 ILCS 665/15: 340B Drug Discount Program study.

(Section scheduled to be repealed on July 1, 2032)

(a) As soon as practical after the effective date of this Act, the Department of Insurance shall conduct a comprehensive study of how 340B covered entities and pharmaceutical manufacturers within Illinois participate in the 340B Drug Discount Program. The study shall include an examination of the impact of this participation by 340B covered entities on State health programs, such as Medicaid and the State Employees Group Insurance Program. The study shall include, but not be limited to, an assessment of:

(1) with respect to each covered entity, the:

(A) name;

(B) service address;

(C) 340B identification number; and

(D) 340B designation, as specified in 42 U.S.C 256b(a)(4);

(2) the aggregate amount, by 340B entity type, spent on third-party administrators for the management of the 340B Drug Discount Program;

(3) the average difference between the cost imposed by each covered entity on 340B-priced drugs and the reimbursement rate for 340B drugs, organized by therapeutic class;

(4) the aggregate and transaction-level acquisition cost paid by a 340B covered entity for all prescription drugs organized by therapeutic class obtained under the 340B Drug Discount Program and dispensed or administered to patients;

(5) the aggregate and transaction-level payment amount received by a 340B covered entity for all drugs organized by therapeutic class obtained under the 340B Drug Discount Program and dispensed or administered to patients;

(6) with respect to 340B covered entities, a list of contract pharmacies contracted with the 340B covered entity to dispense 340B covered drugs;

(7) the aggregate and transaction-level payment made to contract pharmacies to dispense drugs obtained under the 340B Drug Discount Program;

(8) how the 340B covered entity uses any savings from participating in the 340B Drug Discount Program, including the total amount of 340B savings used for the provision of charity care, community benefits (including identification of the benefit program), any similar program of providing unreimbursed or subsidized health care, and any remaining savings for other purposes;

(9) to the extent the information is available, the percentage of total patients of the 340B covered entity that were:

(A) served by a sliding fee scale for a prescription drug dispensed or administered under the 340B Drug Discount Program;

(B) Medicaid customers and uninsured or underinsured patients;

(C) racial and ethnic minority populations;

(D) patients residing in rural or Medically Underserved Areas, including Governor's Exceptions, designated by the Health Resources and Services Administration, an agency of the United States Department of Health and Human Services;

(E) populations with a higher prevalence of chronic disease and poor health outcomes linked to societal determinants of health; and

(F) individuals with disabilities, older adults, LGBTQ+ populations, and justice-involved individuals;

(10) with respect to covered entities, the 340B covered entity's total operating costs;

(11) with respect to covered entities, a copy of the 340B covered entity's financial assistance policy for the reporting year;

(12) identification of the parties involved in the 340B procurement and dispensing process for each covered facility;

(13) the aggregate and transaction-level payment made to a pharmacy services administrative organization that provides pharmacy services for a 340B contract pharmacy;

(14) the aggregate and transaction-level payment made to a pharmacy benefit manager that provides pharmacy benefit management services for a 340B covered entity, if the information has not already been submitted in a pharmaceutical manufacturer 340B audit;

(15) the total cost and number of hours spent preparing the data in response to the study;

(16) with respect to pharmaceutical manufacturers, copies of any 340B audits conducted during the previous calendar year;

(17) the specific pharmaceutical manufacturers that are participating in the 340B Drug Discount Program in Illinois;

(18) with respect to pharmaceutical manufacturers, any restrictions placed by that manufacturer on participation in the 340B Drug Discount Program, any accompanying data supporting those restrictions, and the reasoning;

(19) a description of the impact of the 340B Drug Discount Program on the patients and the community served by each 340B covered entity;

(20) with respect to pharmaceutical manufacturers, and for the purpose of analyzing the impact of the 340B Drug Discount Program, the aggregate amount of all 340B discounts provided for each calendar year beginning in 2020; and

(21) with respect to pharmaceutical manufacturers, the aggregate amount of all 340B discounts provided for each calendar year beginning in 2020, stated as a percentage of the manufacturer's total annual revenues.

(b) The Department of Insurance may adopt rules as necessary to implement this Section.

(c) The Department of Insurance shall request the information described in subsection (a) in a format designated by the Department. All 340B covered entities, and pharmaceutical manufacturers doing business in the State of Illinois, shall comply with requests for information relevant to subsection (a) from the Department of Insurance in the format prescribed and within the timeframe specified. Failure by a covered entity or pharmaceutical manufacturer to submit all requested information described in subsection (a) within 30 calendar days from the time frame specified by the Department shall result in a fine levied by the Director of: (1) $500 per day the information is past due; or (2) $100 per day the information is past due for hospitals with fewer than 100 licensed beds, Critical Access Hospitals, Safety-Net Hospitals, and 340B grantees. Fines collected pursuant to this subsection shall be deposited into the Vulnerable Community Hospital Capital Investment Fund, which is hereby created as a special fund in the State treasury. All moneys in the Vulnerable Community Hospital Capital Investment Fund shall be used to support the health equity framework for supporting access to health care, creating sustainability, and supporting the implementation of the 340B Drug Discount Program. The Department of Insurance shall enforce this Section pursuant to the powers granted to it by law, including, but not limited to, the powers provided under Article XXIV of the Illinois Insurance Code. Subsections (2) through (5) of Section 403A of the Illinois Insurance Code shall apply to the imposition of any fine.

(d) Subject to subsection (e), the Department of Insurance shall maintain the confidentiality of any information submitted under subsection (c) for which the submitting person or entity includes a request that meets the criteria in paragraph (g) of subsection (1) of Section 7 of the Freedom of Information Act, and the information shall not be subject to subpoena in any private civil litigation in this State. Nothing in this Section shall prevent the Department of Insurance from furnishing information collected from 340B covered entities or pharmaceutical manufacturers to State or federal authorities that may investigate, prosecute, or pursue other legal action against a 340B covered entity or pharmaceutical manufacturer for violations of 42 U.S.C. 256b or any applicable State law.

(e) The Department of Insurance shall submit a report of the findings of its study to the General Assembly and to the Governor by July 1, 2028. The report shall provide findings aggregated across 340B covered entities and pharmaceutical manufacturers and shall not disclose information or data attributed to any specific 340B covered entity or pharmaceutical manufacturer. The report shall note any requests for information from the Department of Insurance where the requested information was never submitted. The report shall address whether the data collected by the Department indicates a need for annual or biennial reporting by 340B covered entities. The report may include any aggregated findings related to the populations identified in paragraph (9) of subsection (a). The report shall address whether the data collected by the Department indicates a need for biennial reporting by 340B covered entities.