HB 4327 — AUDITOR GENERAL-340B AUDIT

HB4327 EngrossedEnrolled LRB104 17027 BAB 30442 b AN ACT concerning auditing.

(2) Congress intended the 340B Drug Discount Program to provide discounts to 340B covered entities that provide direct health care to uninsured uninsured and underinsured vulnerable patients.

(3) The appropriate and effective use of the 340B Drug Discount Program is essential for improving health HB4327 EngrossedEnrolled - 2 - LRB104 17027 BAB 30442 b outcomes, particularly for vulnerable and underserved communities in rural, suburban, and urban areas throughout Illinois meeting the definitions of vulnerable communities.

(E) the Stabilization and Sustainability HB4327 EngrossedEnrolled - 3 - LRB104 17027 BAB 30442 b Operational Funding Program;

These communities are characterized by elevated health disparities, limited access to health care services, and increased exposure to risk factors, such as poverty, inadequate insurance coverage, geographic isolation, systemic discrimination, and unmet social determinants of health, including housing, transportation, food security, and environmental conditions, and who, as a result of these conditions, experience reduced access to timely, HB4327 EngrossedEnrolled - 4 - LRB104 17027 BAB 30442 b culturally competent, and geographically proximate community-based hospital and health care services.

(8) This Act is intended solely to establish a state-levelState-level reporting and transparency framework to allow the 340B program to be evaluated, and shall not regulate pricing, reimbursement, or participation in the federal 340B Program.

"340B covered entity" or "covered entity" means an entity in Illinois that qualifies as a covered entity asunder definedSection in340B of the federal Public Health Service Act, 42 U.S.C.

256b(a)(4),256b(a)(4). with a service address in Illinois as of January 1 of the reporting year.

256b,256b. and as stated in Section 10 of the Patient Access to Pharmacy Protection Act.

256b(a)(4),256b(a)(4). and as stated in Section 10 of the Patient Access to Pharmacy Protection Act.

"340B contract pharmacy" means aany pharmacy that entersis intounder a contract with a 340B covered entity to providedispense services340B todrugs HB4327on Engrossedbehalf -of 5the -340B LRB104covered 17027entity BABand 30442is beither the(i) 340Blocated coveredin entity'sHB4327 patients,Enrolled including- dispensing5 entity-owned- 340BLRB104 drugs,17027 BAB 30442 b Illinois and qualifies as stateda inpharmacy under Section 103 of the Patient Access to Pharmacy ProtectionPractice Act.Act;

or (ii) is located in a state, commonwealth, or territory of the United States, other than Illinois, and dispenses 340B drugs on behalf of the 340B covered entity.

"340B grantee" means an entity in Illinois that qualifies as a covered entity under subparagraphs (A)-(K) of paragraph (4) of subsection (a) of Section 340B of the federal Public Health Service Act, 42 U.S.C.

256b(a)(4)(A)-(K).

"Critical Access Hospital" has the meaning given to that term in paragraph (4) of subsection (b) of Section 5-5e of the Illinois Public Aid Code.

"Hospital" means a hospital licensed under the Hospital Licensing Act or University of Illinois Hospital Act.

"Pharmaceutical manufacturer" has the meaning given to the term "manufacturer" in the Wholesale Drug Distribution Licensing Act.

"Pharmaceutical"Safety-Net manufacturer"Hospital" meanshas anthe entitymeaning given to that isterm engagedSection in:5-5e.1 of the Illinois Public Aid Code.

(1) the production, preparation, propagation, compounding, conversion, or processing of prescription drug products, either directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis;

or (2) the packaging, repackaging, labeling, relabeling, or distribution of prescription drug products.

"Pharmaceutical manufacturer" does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law.

HB4327 Enrolled - 6 - LRB104 17027 BAB 30442 b (2) racial and ethnic minority populations and historically marginalized groups experiencing systemic inequities;

HB4327 Engrossed - 6 - LRB104 17027 BAB 30442 b (3) rural and medically underserved areas with limited provider access or hospital closures;

HB4327 Enrolled - 7 - LRB104 17027 BAB 30442 b (A) name;

and HB4327 Engrossed - 7 - LRB104 17027 BAB 30442 b (D) 340B designation, as specified in 42 U.S.C 256b(a)(4);

(2) with respect to covered entities, the aggregate amount, by 340B entity type, ofspent 340Bon revenue,third-party definedadministrators asfor the totalmanagement patientof and payer reimbursement less the total 340B acquisitionDrug cost,Discount generatedProgram; by 340B covered entities from both self-administered and physician-administered drugs;

(3) the aggregateaverage amount,difference bybetween 340Bthe entitycost type,imposed spentby each covered entity on third-party340B-priced administratorsdrugs forand the managementreimbursement ofrate thefor 340B Drugdrugs, Discountorganized Program;by therapeutic class;

(4) the aggregate amount,and transaction-level acquisition cost paid by a 340B covered entity type,for paidall toprescription contractdrugs pharmacies;organized by therapeutic class obtained under the 340B Drug Discount Program and dispensed or administered to patients;

(5) the averageaggregate markupand imposedtransaction-level payment amount received by eacha 340B covered entity onfor 340B-pricedall drugs organized by therapeutic class;class obtained under the 340B Drug Discount Program and dispensed or administered to patients;

(6) thewith aggregaterespect andto transaction-level acquisition cost paid by a 340B covered entityentities, fora alllist prescriptionof drugscontract organizedpharmacies bycontracted therapeuticwith class obtained under the 340B Drugcovered Discountentity Programto anddispense dispensed340B orcovered administereddrugs; to patients;

(7) the aggregate and transaction-level payment amountmade receivedto bycontract apharmacies 340Bto covereddispense entitydrugs forobtained allunder drugsHB4327 organizedEnrolled by- therapeutic8 class- obtainedLRB104 under17027 BAB 30442 b the 340B Drug Discount ProgramProgram; and dispensed or administered to patients;

(8) withhow respectthe to 340B covered entities,entity auses listany ofsavings contractfrom pharmaciesparticipating contractedin withthe 340B Drug Discount Program, including the total amount of 340B coveredsavings HB4327used Engrossedfor -the 8provision -of LRB104charity 17027care, BABcommunity 30442benefits b(including entityidentification toof dispensethe 340Bbenefit coveredprogram), drugs;any similar program of providing unreimbursed or subsidized health care, and any remaining savings for other purposes;

(9) to the aggregateextent andthe transaction-levelinformation paymentis madeavailable, tothe contractpercentage pharmaciesof tototal dispensepatients drugsof obtained under the 340B Drugcovered Discountentity Program;that were:

(10) the following claims data:

(A) the number of claims for prescription drugs described in paragraph (7) organized by therapeutic class of drug;

and (B) the percentage of the 340B covered entity's claims that included prescription drugs obtained under the 340B Drug Discount Program;

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

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

HB4327 Engrossed - 9 - LRB104 17027 BAB 30442 b (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;

and (F) individuals with disabilities, older adults, HB4327 Enrolled - 9 - LRB104 17027 BAB 30442 b LGBTQ+ populations, and justice-involved individuals;