Illinois 2023-2024 Regular Session

Illinois House Bill HB4525 Compare Versions

Only one version of the bill is available at this time.

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1	1	103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED: New Act Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024. LRB103 36423 RPS 66525 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED: New Act New Act Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024. LRB103 36423 RPS 66525 b LRB103 36423 RPS 66525 b A BILL FOR
2	2	103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED:
3	3	New Act New Act
4	4	New Act
5	5	Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024.
6	6	LRB103 36423 RPS 66525 b LRB103 36423 RPS 66525 b
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8	8	A BILL FOR
9	9	HB4525LRB103 36423 RPS 66525 b HB4525 LRB103 36423 RPS 66525 b
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11	11	1 AN ACT concerning health.
12	12	2 Be it enacted by the People of the State of Illinois,
13	13	3 represented in the General Assembly:
14	14	4 Section 1. Short title. This Act may be cited as the
15	15	5 Wholesale Prescription Drug Importation Program Act.
16	16	6 Section 5. Definitions. As used in this Act:
17	17	7 "Canadian supplier" means a manufacturer, wholesale
18	18	8 distributor, or pharmacy that is appropriately licensed or
19	19	9 permitted under Canadian federal or provincial laws and rules
20	20	10 to manufacture, distribute, or dispense prescription drugs.
21	21	11 "Department" means the Department of Public Health.
22	22	12 "Director" means the Director of Public Health.
23	23	13 "Prescription drug wholesaler" means a person or entity
24	24	14 licensed as a wholesale drug distributor under the Wholesale
25	25	15 Drug Distribution Licensing Act, that contracts with this
26	26	16 State to import prescription drugs under the program.
27	27	17 "Program" means the Wholesale Prescription Drug
28	28	18 Importation Program.
29	29	19 Section 10. Wholesale Prescription Drug Importation
30	30	20 Program.
31	31	21 (a) The Department shall establish the Wholesale
32	32	22 Prescription Drug Importation Program to provide lower cost
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36	36	103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB4525 Introduced , by Rep. Maurice A. West, II SYNOPSIS AS INTRODUCED:
37	37	New Act New Act
38	38	New Act
39	39	Creates the Wholesale Prescription Drug Importation Program Act. Requires the Department of Public Health to establish the Wholesale Prescription Drug Importation Program. Provides that the Department shall implement the program by: contracting with one or more prescription drug wholesalers and Canadian suppliers to import prescription drugs and provide prescription drug cost savings to consumers in this State; developing a registration process for health benefit plan issuers, health care providers, and pharmacies to obtain and dispense prescription drugs imported under the program; developing a list of prescription drugs, including the prices of those drugs, that meet certain requirements set forth under the Act and publishing the list on the Department's website; establishing an outreach and marketing plan to generate program awareness; ensuring the program and the prescription drug wholesalers that contract with this State comply with certain federal tracking, tracing, verification, and identification requirements; and other actions. Sets forth eligibility criteria for prescription drugs that may be imported into the State under the program. Contains provisions concerning anticompetitive behavior monitoring; program funding; program expansion; audit procedures; annual reporting requirements; the adoption of rules to implement the Act; and federal waiver or authorization requirements. Effective July 1, 2024.
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41	41	LRB103 36423 RPS 66525 b
42	42	A BILL FOR
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67	67	1 prescription drugs available outside of the United States to
68	68	2 consumers in this State at the lower cost.
69	69	3 (b) The Department shall implement the program by:
70	70	4 (1) contracting with one or more prescription drug
71	71	5 wholesalers and Canadian suppliers to import prescription
72	72	6 drugs and provide prescription drug cost savings to
73	73	7 consumers in this State;
74	74	8 (2) developing a registration process for health
75	75	9 benefit plan issuers, health care providers, and
76	76	10 pharmacies to obtain and dispense prescription drugs
77	77	11 imported under the program;
78	78	12 (3) developing a list of prescription drugs, including
79	79	13 the prices of those drugs, that meet the requirements of
80	80	14 Section 15 and publishing the list on the Department's
81	81	15 website;
82	82	16 (4) establishing an outreach and marketing plan to
83	83	17 generate program awareness;
84	84	18 (5) establishing and administering a telephone call
85	85	19 center or electronic portal to provide information about
86	86	20 the program;
87	87	21 (6) ensuring the program and the prescription drug
88	88	22 wholesalers that contract with this State under paragraph
89	89	23 (1) comply with the tracking, tracing, verification, and
90	90	24 identification requirements of 21 U.S.C. 360eee-1;
91	91	25 (7) prohibiting the distribution, dispensing, or sale
92	92	26 of prescription drugs imported under this Act outside the
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103	103	1 boundaries of this State; and
104	104	2 (8) performing any other duties the Director
105	105	3 determines necessary to implement the program.
106	106	4 (c) The Department shall ensure that the program meets the
107	107	5 requirements of 21 U.S.C. 384.
108	108	6 (d) In developing the program, the Department may consult
109	109	7 with interested parties.
110	110	8 Section 15. Eligible prescription drugs. A prescription
111	111	9 drug may be imported into this State under the program only if
112	112	10 the drug:
113	113	11 (1) meets the United States Food and Drug
114	114	12 Administration's standards related to prescription drug
115	115	13 safety, effectiveness, misbranding, and adulteration;
116	116	14 (2) does not violate any federal patent laws through
117	117	15 its importation;
118	118	16 (3) is expected to generate cost savings for
119	119	17 consumers; and
120	120	18 (4) is not:
121	121	19 (A) listed as a controlled substance under State
122	122	20 or federal law;
123	123	21 (B) a biological product;
124	124	22 (C) an infused drug;
125	125	23 (D) an intravenously injected drug;
126	126	24 (E) a drug that is inhaled during surgery; or
127	127	25 (F) a parenteral drug.
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138	138	1 Section 20. Program expansion. In its discretion, the
139	139	2 Department may by rule expand the Program to import
140	140	3 prescription drugs from any other country that is allowed
141	141	4 under federal law to import prescription drugs into the United
142	142	5 States.
143	143	6 Section 25. Anticompetitive behavior monitoring. The
144	144	7 Department, in consultation with the Attorney General, shall
145	145	8 identify and monitor any potential anticompetitive activities
146	146	9 in industries affected by the program.
147	147	10 Section 30. Program funding. In addition to money
148	148	11 appropriated by the General Assembly, the Department may
149	149	12 impose a fee on each prescription drug sold under the program
150	150	13 or establish another funding method to administer the program.
151	151	14 Section 35. Audit procedures. The Director, by rule, shall
152	152	15 develop procedures to effectively audit a prescription drug
153	153	16 wholesaler participating in the program.
154	154	17 Section 40. Annual reporting. Not later than December 1,
155	155	18 2025, and each December 1 thereafter, the Department shall
156	156	19 submit a report to the Governor and the General Assembly
157	157	20 regarding the operation of the program during the preceding
158	158	21 State fiscal year, including:
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169	169	1 (1) which prescription drugs and Canadian suppliers
170	170	2 are included in the program;
171	171	3 (2) the number of health benefit plan issuers, health
172	172	4 care providers, and pharmacies participating in the
173	173	5 program;
174	174	6 (3) the number of prescriptions dispensed through the
175	175	7 program;
176	176	8 (4) the estimated cost savings to consumers, health
177	177	9 plans, employers, and this State since the establishment
178	178	10 of the program and during the preceding State fiscal year;
179	179	11 (5) information regarding the implementation of the
180	180	12 audit procedures under Section 35; and
181	181	13 (6) any other information:
182	182	14 (A) the Governor or the General Assembly requests;
183	183	15 or
184	184	16 (B) the Department considers necessary.
185	185	17 Section 45. Rules. As soon as practicable after the
186	186	18 effective date of this Act, the Director shall adopt any rules
187	187	19 necessary to implement this Act.
188	188	20 Section 50. Federal waiver or authorization. If, before
189	189	21 implementing any provision of this Act, a State agency
190	190	22 determines that a waiver or authorization from a federal
191	191	23 agency is necessary for implementation of that provision, the
192	192	24 agency affected by the provision shall request the waiver or
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203	203	1 authorization and may delay implementing that provision until
204	204	2 the waiver or authorization is granted.
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