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| 1 | AN ACT concerning auditing. | |||||||||||||||||||
| 2 | Be it enacted by the People of the State of Illinois, | |||||||||||||||||||
| 3 | represented in the General Assembly: | |||||||||||||||||||
| 4 | Section 1. Findings. The General Assembly finds that: | |||||||||||||||||||
| 5 | (1) The original intent of the 340B Drug Discount | |||||||||||||||||||
| 6 | Program was to provide discounted medicines to eligible | |||||||||||||||||||
| 7 | healthcare organizations for the purpose of improving | |||||||||||||||||||
| 8 | access to affordable medications for low-income, | |||||||||||||||||||
| 9 | underinsured, and uninsured patients being treated at | |||||||||||||||||||
| 10 | eligible hospitals, including disproportionate share | |||||||||||||||||||
| 11 | hospitals, clinics, federally qualified health centers | |||||||||||||||||||
| 12 | (FQHC), and safety-net hospitals. | |||||||||||||||||||
| 13 | (2) Congress intended the 340B Drug Discount Program | |||||||||||||||||||
| 14 | to provide discounts only to federally-funded clinics and | |||||||||||||||||||
| 15 | public hospitals that provide direct clinical care to | |||||||||||||||||||
| 16 | large numbers of uninsured Americans. | |||||||||||||||||||
| 17 | (3) The lack of transparency and accountability of the | |||||||||||||||||||
| 18 | 340B Program has resulted in the expansion of services to | |||||||||||||||||||
| 19 | commercially insured patient populations who are charged | |||||||||||||||||||
| 20 | full price for drugs purchased at steeply discounted 340B | |||||||||||||||||||
| 21 | prices, resulting in the intended benefit to not reach the | |||||||||||||||||||
| 22 | vulnerable patient populations that the program was | |||||||||||||||||||
| 23 | designed to help. | |||||||||||||||||||
| 24 | (4) The appropriate and effective use of the 340B Drug | |||||||||||||||||||
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| 1 | Discount Program is essential for improving health | ||||||
| 2 | outcomes, particularly for underserved communities in | ||||||
| 3 | rural, suburban, and urban areas throughout Illinois. | ||||||
| 4 | (5) The integrity and efficacy of State health | ||||||
| 5 | programs, such as Medicaid and the State Employees Group | ||||||
| 6 | Insurance Program, could be impacted by the lack of | ||||||
| 7 | transparency of the 340B Drug Discount Program and current | ||||||
| 8 | practices. | ||||||
| 9 | Section 5. The Illinois State Auditing Act is amended by | ||||||
| 10 | adding Section 3-1B as follows: | ||||||
| 11 | (30 ILCS 5/3-1B new) | ||||||
| 12 | Sec. 3-1B. 340B Drug Discount Program audit. | ||||||
| 13 | (a) In this Section: | ||||||
| 14 | "340B covered entity" means a covered entity as defined in | ||||||
| 15 | 42 U.S.C. 256b(a)(4) authorized to participate in the 340B | ||||||
| 16 | Drug Discount Program. | ||||||
| 17 | "340B Drug Discount Program" means the program established | ||||||
| 18 | under Section 340B of the federal Public Health Service Act, | ||||||
| 19 | 42 U.S.C. 256b. | ||||||
| 20 | "Contract pharmacy" means a pharmacy that enters into a | ||||||
| 21 | contract with a 340B covered entity to provide services to the | ||||||
| 22 | 340B covered entity's patients, including dispensing | ||||||
| 23 | entity-owned 340B drugs. | ||||||
| 24 | (b) As soon as practical after the effective date of this | ||||||
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| 1 | amendatory Act of the 104th General Assembly, the Auditor | ||||||
| 2 | General shall conduct a comprehensive investigation of how | ||||||
| 3 | 340B covered entities within Illinois participate in the 340B | ||||||
| 4 | Drug Discount Program. The investigation shall examine the | ||||||
| 5 | impact of this participation by 340B covered entities on State | ||||||
| 6 | health programs, such as Medicaid and the State Employees | ||||||
| 7 | Group Insurance Program, and shall include, but not be limited | ||||||
| 8 | to, an assessment of: | ||||||
| 9 | (1) the amount of 340B profit, defined as the total | ||||||
| 10 | patient and payer reimbursement less the total 340B | ||||||
| 11 | acquisition cost, generated by 340B covered entities from | ||||||
| 12 | both self-administered and physician-administered drugs; | ||||||
| 13 | (2) the amount spent on third-party administrators for | ||||||
| 14 | the management of the 340B Drug Discount Program; | ||||||
| 15 | (3) the amount paid to pharmacy benefit managers in | ||||||
| 16 | contract pharmacy arrangements; | ||||||
| 17 | (4) the amount paid to contract pharmacies; | ||||||
| 18 | (5) whether covered entities maintain title to 340B | ||||||
| 19 | drugs in contract pharmacy locations; | ||||||
| 20 | (6) the average markup imposed by covered entities on | ||||||
| 21 | 340B-priced drugs; and | ||||||
| 22 | (7) the extent to which 340B entities pass 340B | ||||||
| 23 | discounts to vulnerable patients at the point of sale for | ||||||
| 24 | both in-house and contracted pharmacies. | ||||||
| 25 | (c) The Auditor General shall make recommendations to the | ||||||
| 26 | General Assembly based on the findings from the investigation. | ||||||