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HB4327 Engrossed LRB104 17027 BAB 30442 b AN ACT concerning auditing.
HB4327 Enrolled 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.
(2) Congress intended the 340B Drug Discount Program to provide discounts to 340B covered entities that provide direct health care to uninsured and underinsured vulnerable patients.
(3) The appropriate and effective use of the 340B Drug Discount Program is essential for improving health HB4327 Engrossed - 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.
(3) The appropriate and effective use of the 340B Drug Discount Program is essential for improving health HB4327 Enrolled - 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 Engrossed - 3 - LRB104 17027 BAB 30442 b Operational Funding Program;
(E) the Stabilization and Sustainability HB4327 Enrolled - 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 Engrossed - 4 - LRB104 17027 BAB 30442 b culturally competent, and geographically proximate community-based hospital and health care services.
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 Enrolled - 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-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.
(8) This Act is intended solely to establish a State-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 a covered entity as defined in 42 U.S.C.
"340B covered entity" or "covered entity" means an entity in Illinois that qualifies as a covered entity under Section 340B of the federal Public Health Service Act, 42 U.S.C.
256b(a)(4), with a service address in Illinois as of January 1 of the reporting year.
256b(a)(4).
256b, and as stated in Section 10 of the Patient Access to Pharmacy Protection Act.
256b.
256b(a)(4), and as stated in Section 10 of the Patient Access to Pharmacy Protection Act.
256b(a)(4).
"340B contract pharmacy" means a pharmacy that enters into a contract with a 340B covered entity to provide services to HB4327 Engrossed - 5 - LRB104 17027 BAB 30442 b the 340B covered entity's patients, including dispensing entity-owned 340B drugs, and as stated in Section 10 of the Patient Access to Pharmacy Protection Act.
"340B contract pharmacy" means any pharmacy that is under contract with a 340B covered entity to dispense 340B drugs on behalf of the 340B covered entity and is either (i) located in HB4327 Enrolled - 5 - LRB104 17027 BAB 30442 b Illinois and qualifies as a pharmacy under Section 3 of the Pharmacy Practice 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 manufacturer" means an entity that is engaged in:
"Safety-Net Hospital" has the meaning given to that term Section 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.
(2) racial and ethnic minority populations and historically marginalized groups experiencing systemic inequities;
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;
(3) rural and medically underserved areas with limited provider access or hospital closures;
(A) name;
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);
and (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, of 340B revenue, defined as the total patient and payer reimbursement less the total 340B acquisition cost, generated by 340B covered entities from both self-administered and physician-administered drugs;
(2) the aggregate amount, by 340B entity type, spent on third-party administrators for the management of the 340B Drug Discount Program;
(3) 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 amount, by 340B entity type, paid to contract pharmacies;
(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 average markup imposed by each covered entity on 340B-priced drugs organized by therapeutic class;
(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) 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;
(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 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;
(7) the aggregate and transaction-level payment made to contract pharmacies to dispense drugs obtained under HB4327 Enrolled - 8 - LRB104 17027 BAB 30442 b the 340B Drug Discount Program;
(8) with respect to 340B covered entities, a list of contract pharmacies contracted with the 340B covered HB4327 Engrossed - 8 - LRB104 17027 BAB 30442 b entity to dispense 340B covered drugs;
(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) the aggregate and transaction-level payment made to contract pharmacies to dispense drugs obtained under the 340B Drug Discount Program;
(9) to the extent the information is available, the percentage of total patients of the 340B covered entity 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;
(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, LGBTQ+ populations, and justice-involved individuals;
and (F) individuals with disabilities, older adults, HB4327 Enrolled - 9 - LRB104 17027 BAB 30442 b LGBTQ+ populations, and justice-involved individuals;
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(13) with respect to covered entities, the 340B covered entity's total operating costs;
(10) with respect to covered entities, the 340B covered entity's total operating costs;
(14) with respect to covered entities, the 340B covered entity's total costs for community benefits, including charity care;
(11) with respect to covered entities, a copy of the 340B covered entity's financial assistance policy for the reporting year;
(15) 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;
(16) 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;
(17) 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;
(18) the aggregate and transaction-level 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, 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;
(19) 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;
(20) 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;
(21) the specific pharmaceutical manufacturers that are participating in the 340B Drug Discount Program in Illinois;
(18) with respect to pharmaceutical manufacturers, any HB4327 Enrolled - 10 - LRB104 17027 BAB 30442 b restrictions placed by that manufacturer on participation in the 340B Drug Discount Program, any accompanying data supporting those restrictions, and the reasoning;
(22) 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;
(23) 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 (24) 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.
HB4327 Engrossed - 11 - LRB104 17027 BAB 30442 b (c) The Department of Insurance shall request the information described in subsection (a).
(c) The Department of Insurance shall request the information described in subsection (a) in a format designated by the Department.
All 340B covered entities, insurers 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.
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.
The Department of Insurance is hereby granted specific authority to fine any 340B covered entity, insurer, pharmacy benefit manager, third-party administrator, or administrative services organization that fails to comply with this Section within 30 calendar days after the due date specified by the Department of Insurance, at a rate of $100 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 information is past due.
Failure by a covered entity or pharmaceutical manufacturer to submit all requested information described in subsection (a) within HB4327 Enrolled - 11 - LRB104 17027 BAB 30442 b 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.
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.
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.
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.
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 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 may include any aggregated findings related to the populations identified in paragraph (12) of subsection (a).
The report may include any aggregated findings related to the populations identified in paragraph (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 as follows:
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.
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 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 court may order:
(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:
(30 ILCS 105/5.1038 new) Sec.
HB4327 Enrolled - 15 - LRB104 17027 BAB 30442 b (30 ILCS 105/5.1038 new) Sec.
This Act takes effect upon becoming law, but Section 900 does not take 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.
This Act takes effect upon becoming law or on the effective date of 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.
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