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;
(13)(10) with respect to covered entities, the 340B covered entity's total operating costs;
(14)(11) with respect to covered entities, a copy of the 340B covered entity's totalfinancial costsassistance policy for communitythe benefits,reporting includingyear; charity care;
(15)(12) withidentification respectof tothe coveredparties entities,involved ain copy of the 340B coveredprocurement entity'sand financialdispensing assistanceprocess policy for theeach reportingcovered year;facility;
(16)(13) identificationthe ofaggregate theand partiestransaction-level involvedpayment inmade theto 340Ba procurementpharmacy andservices dispensingadministrative processorganization that provides pharmacy services for eacha covered340B facility;contract pharmacy;
(17)(14) the aggregate and transaction-level payment made to a pharmacy servicesbenefit administrativemanager organization that provides pharmacy benefit management services for a 340B contractcovered pharmacy;entity, if the information has not already been submitted in a pharmaceutical manufacturer 340B audit;
(18)(15) the aggregatetotal cost and transaction-levelnumber payment made to a pharmacy benefit manager that provides pharmacy HB4327 Engrossed - 10 - LRB104 17027 BAB 30442 b benefit management services for a 340B covered entity organized by therapeutic class of drug,hours ifspent preparing the informationdata has not already been submitted in aresponse pharmaceuticalto manufacturerthe 340Bstudy; audit;
(19)(16) thewith totalrespect costto andpharmaceutical numbermanufacturers, copies of hoursany spent340B preparingaudits theconducted dataduring inthe responseprevious tocalendar theyear; study;
(20)(17) withthe respectspecific to pharmaceutical manufacturers,manufacturers copiesthat ofare anyparticipating 340Bin auditsthe conducted340B duringDrug theDiscount previousProgram calendarin year;Illinois;
(21)(18) thewith specificrespect to pharmaceutical manufacturersmanufacturers, any HB4327 Enrolled - 10 - LRB104 17027 BAB 30442 b restrictions placed by that aremanufacturer participatingon participation in the 340B Drug Discount ProgramProgram, inany Illinois;accompanying data supporting those restrictions, and the reasoning;
(22)(19) witha respectdescription toof pharmaceuticalthe manufacturers,impact anyof restrictionsthe placed340B byDrug thatDiscount manufacturerProgram on participation in the 340Bpatients Drugand Discountthe Program,community anyserved accompanyingby dataeach supporting340B thosecovered restrictions,entity; and the reasoning;
(23)(20) awith descriptionrespect to pharmaceutical manufacturers, and for the purpose of analyzing the impact of the 340B Drug Discount ProgramProgram, on the patientsaggregate andamount theof communityall served340B bydiscounts provided for each 340Bcalendar coveredyear entity;beginning in 2020;
and (24)(21) 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 2020.2020, stated as a percentage of the manufacturer's total annual revenues.
HB4327 Engrossed - 11 - LRB104 17027 BAB 30442 b (c) The Department of Insurance shall request the information described in subsection (a).(a) in a format designated by the Department.
All 340B covered entities, insurersand as defined in subsection (a-5) of Section 513b1 of the Illinois Insurance Code, pharmacy benefit managers, third-party administrators, pharmaceutical manufacturers doing business in the State of Illinois, and administrative service organizations of the State Employees Group Insurance Program shall comply with requests for information relevant to subsection (a) from the Department of Insurance in the format prescribed and within the timeframe specified.
TheFailure Departmentby ofa Insurancecovered isentity herebyor grantedpharmaceutical specificmanufacturer authority to finesubmit anyall 340Brequested coveredinformation entity,described insurer,in pharmacysubsection benefit(a) manager,within third-partyHB4327 administrator,Enrolled or- administrative11 services- organizationLRB104 that17027 failsBAB to30442 complyb with this Section within 30 calendar days afterfrom the duetime dateframe specified by the Department ofshall Insurance,result atin a ratefine oflevied $100by per day for each day beyond 30 calendar days for federally qualified health centers and historical safety-net hospitals, and at a rate of $500 per day for each day beyond 30 calendar days for all other entities, that the informationDirector isof: past due.
(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.
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, HB4327 Engrossed - 12 - LRB104 17027 BAB 30442 b creating sustainability, and supporting the implementation of the 340B Drug Discount Program.
HB4327 Enrolled - 12 - LRB104 17027 BAB 30442 b 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.
The report shall provide findings aggregated across 340B covered entities and pharmaceutical manufacturers and shall not disclose information or data HB4327 Engrossed - 13 - LRB104 17027 BAB 30442 b attributed to any specific 340B covered entity or pharmaceutical manufacturer.
The report may include any aggregated findings related to the populations identified in paragraph (12)(9) of subsection (a).
Section 20.
Severability.
If any provision of this Act or the Patient Access to Pharmacy Act is held invalid by a court, HB4327 Enrolled - 13 - LRB104 17027 BAB 30442 b the validity of the remainder of this Act and the Patient Access to Pharmacy Act shall not be affected by that determination of invalidity.
If the applicability of any provision of this Act or the Patient Access to Pharmacy Act to any person or circumstance is held invalid by a court, the applicability of that provision to other persons or circumstances shall not be affected by that determination of invalidity.
If and only if House Bill 2371 of the 104th General Assembly becomes law, then the Patient Access to Pharmacy Protection Act is amended by changing Section 40 and Section 99 as follows:
If the Attorney General has reasonable cause to believe that there is or has been a violation of Section 15 of this Act, then the Attorney General may commence a civil action in the HB4327 Engrossed - 14 - LRB104 17027 BAB 30442 b name of the People of the State of Illinois to enforce the provisions of this Act in the appropriate circuit court.
(b) Upon finding a violation of Section 15 of this Act, a HB4327 Enrolled - 14 - LRB104 17027 BAB 30442 b court may order:
10400HB2371sam002.) (10400HB2371sam002, Sec.
99) Sec.
99.
Effective date.
This Act takes effect upon becoming law or on the effective date of House Bill 4327 of the 104th General Assembly, whichever is later;
however, this Act does not take effect at all unless House Bill 4327 of the 104th General Assembly becomes law.
(Source:
HB4327 Enrolled - 15 - LRB104 17027 BAB 30442 b (30 ILCS 105/5.1038 new) Sec.
This Act takes effect upon becoming law,law butor Sectionon 900the doeseffective notdate takeof effect at all HB4327 Engrossed - 15 - LRB104 17027 BAB 30442 b unless House Bill 2371 of the 104th General Assembly, as amended by Senate Amendment No.
2, whichever is later;
however, this Act does not take effect at all unless House Bill 2371 of the 104th General Assembly, as amended by Senate Amendment No.