Illinois 2025-2026 Regular Session

Illinois House Bill HB2512 Compare Versions

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

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1	1	104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB2512 Introduced , by Rep. Jed Davis SYNOPSIS AS INTRODUCED: New Act30 ILCS 105/5.1030 new Creates the Accountability in Psychotropic Drug Prescriptions for Children Under Medicaid Act. Requires medical care providers prescribing psychotropic drugs to children under the State's Medicaid program to provide FDA Medication Guides to parents or legal guardians before issuing a prescription. Provides that the Medication Guides must be printed and reviewed with the parent or legal guardian, explaining (1) FDA-identified risks of the medication, including pediatric-specific warnings and (2) signs of potential side effects and adverse drug reactions detailed in the Medication Guide. Provides that written informed consent must be obtained from the parent or legal guardian before prescribing a psychotropic drug. Requires the Department of Healthcare and Family Services to, within 12 months after the effective date of the Act, develop and maintain a secure online reporting system for adverse drug reactions related to psychotropic drugs prescribed to children and adolescents. Contains provisions on adverse drug reaction reporting requirements; legislative oversight and reviews of adverse drug reaction reports related to psychotropic drugs; penalties for medical care providers who fail to comply with medication guide distribution; transparency and accountability reporting requirements for the Department of Healthcare and Family Services; and other matters. Amends the State Finance Act. Creates the Medicaid Oversight and Safety Measures Fund. LRB104 10052 KTG 20123 b A BILL FOR 104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB2512 Introduced , by Rep. Jed Davis SYNOPSIS AS INTRODUCED: New Act30 ILCS 105/5.1030 new New Act 30 ILCS 105/5.1030 new Creates the Accountability in Psychotropic Drug Prescriptions for Children Under Medicaid Act. Requires medical care providers prescribing psychotropic drugs to children under the State's Medicaid program to provide FDA Medication Guides to parents or legal guardians before issuing a prescription. Provides that the Medication Guides must be printed and reviewed with the parent or legal guardian, explaining (1) FDA-identified risks of the medication, including pediatric-specific warnings and (2) signs of potential side effects and adverse drug reactions detailed in the Medication Guide. Provides that written informed consent must be obtained from the parent or legal guardian before prescribing a psychotropic drug. Requires the Department of Healthcare and Family Services to, within 12 months after the effective date of the Act, develop and maintain a secure online reporting system for adverse drug reactions related to psychotropic drugs prescribed to children and adolescents. Contains provisions on adverse drug reaction reporting requirements; legislative oversight and reviews of adverse drug reaction reports related to psychotropic drugs; penalties for medical care providers who fail to comply with medication guide distribution; transparency and accountability reporting requirements for the Department of Healthcare and Family Services; and other matters. Amends the State Finance Act. Creates the Medicaid Oversight and Safety Measures Fund. LRB104 10052 KTG 20123 b LRB104 10052 KTG 20123 b A BILL FOR
2	2	104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB2512 Introduced , by Rep. Jed Davis SYNOPSIS AS INTRODUCED:
3	3	New Act30 ILCS 105/5.1030 new New Act 30 ILCS 105/5.1030 new
4	4	New Act
5	5	30 ILCS 105/5.1030 new
6	6	Creates the Accountability in Psychotropic Drug Prescriptions for Children Under Medicaid Act. Requires medical care providers prescribing psychotropic drugs to children under the State's Medicaid program to provide FDA Medication Guides to parents or legal guardians before issuing a prescription. Provides that the Medication Guides must be printed and reviewed with the parent or legal guardian, explaining (1) FDA-identified risks of the medication, including pediatric-specific warnings and (2) signs of potential side effects and adverse drug reactions detailed in the Medication Guide. Provides that written informed consent must be obtained from the parent or legal guardian before prescribing a psychotropic drug. Requires the Department of Healthcare and Family Services to, within 12 months after the effective date of the Act, develop and maintain a secure online reporting system for adverse drug reactions related to psychotropic drugs prescribed to children and adolescents. Contains provisions on adverse drug reaction reporting requirements; legislative oversight and reviews of adverse drug reaction reports related to psychotropic drugs; penalties for medical care providers who fail to comply with medication guide distribution; transparency and accountability reporting requirements for the Department of Healthcare and Family Services; and other matters. Amends the State Finance Act. Creates the Medicaid Oversight and Safety Measures Fund.
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12	12	1 AN ACT concerning health care.
13	13	2 Be it enacted by the People of the State of Illinois,
14	14	3 represented in the General Assembly:
15	15	4 Section 1. Short title. This Act may be cited as the
16	16	5 Accountability in Psychotropic Drug Prescriptions for Children
17	17	6 Under Medicaid Act.
18	18	7 Section 5. Legislative findings. The General Assembly
19	19	8 finds the following:
20	20	9 (1) In 2023, Illinois' Medicaid program statistics
21	21	10 showed 96,841 children and adolescents aged 0-17 being
22	22	11 prescribed psychotropic drugs, including 7,227 children
23	23	12 aged 0-5.
24	24	13 (2) The administration of nearly every psychotropic
25	25	14 drug to children aged 0-5 is off-label, meaning the drugs
26	26	15 are being prescribed for age groups not approved by the
27	27	16 U.S. Food and Drug Administration (FDA).
28	28	17 (3) Psychotropic drugs, including stimulants,
29	29	18 antidepressants, antipsychotics, and other behavioral
30	30	19 drugs, are being prescribed to children using Medicaid
31	31	20 funding and are documented by the FDA to include severe
32	32	21 side effects, including, but not limited to, addiction,
33	33	22 suicidal ideation, aggression, hallucinations,
34	34	23 cardiovascular events, stunted growth, and developmental
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38	38	104TH GENERAL ASSEMBLY State of Illinois 2025 and 2026 HB2512 Introduced , by Rep. Jed Davis SYNOPSIS AS INTRODUCED:
39	39	New Act30 ILCS 105/5.1030 new New Act 30 ILCS 105/5.1030 new
40	40	New Act
41	41	30 ILCS 105/5.1030 new
42	42	Creates the Accountability in Psychotropic Drug Prescriptions for Children Under Medicaid Act. Requires medical care providers prescribing psychotropic drugs to children under the State's Medicaid program to provide FDA Medication Guides to parents or legal guardians before issuing a prescription. Provides that the Medication Guides must be printed and reviewed with the parent or legal guardian, explaining (1) FDA-identified risks of the medication, including pediatric-specific warnings and (2) signs of potential side effects and adverse drug reactions detailed in the Medication Guide. Provides that written informed consent must be obtained from the parent or legal guardian before prescribing a psychotropic drug. Requires the Department of Healthcare and Family Services to, within 12 months after the effective date of the Act, develop and maintain a secure online reporting system for adverse drug reactions related to psychotropic drugs prescribed to children and adolescents. Contains provisions on adverse drug reaction reporting requirements; legislative oversight and reviews of adverse drug reaction reports related to psychotropic drugs; penalties for medical care providers who fail to comply with medication guide distribution; transparency and accountability reporting requirements for the Department of Healthcare and Family Services; and other matters. Amends the State Finance Act. Creates the Medicaid Oversight and Safety Measures Fund.
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71	71	1 concerns.
72	72	2 (4) Parents and caregivers are frequently not informed
73	73	3 of the FDA-documented risks associated with the
74	74	4 psychotropics being prescribed, including the pediatric
75	75	5 risks.
76	76	6 (5) Section 208.20 of Title 21 of the United States
77	77	7 Code of Federal Regulations (CFR) establishes the
78	78	8 requirement for FDA Medication Guides to provide easily
79	79	9 understandable information about the risks and side
80	80	10 effects of prescription drugs for the average consumer,
81	81	11 including parents and caregivers. According to federal
82	82	12 regulations, Medication Guides must:
83	83	13 (A) Detail "the particular serious and significant
84	84	14 public health concern that has created the need for
85	85	15 the Medication Guide".
86	86	16 (B) Note any known "pediatric risks".
87	87	17 (C) Include the risk of "patients developing
88	88	18 dependence on the drug product".
89	89	19 (D) Use a font size no smaller than 10-point.
90	90	20 (E) Be written in "nontechnical, understandable
91	91	21 language".
92	92	22 (F) "Not be promotional in tone or content".
93	93	23 (6) To effectively monitor the effects of psychotropic
94	94	24 drugs prescribed to children and adolescents, particularly
95	95	25 the FDA-cited "pediatric effects", parents and caregivers
96	96	26 must be given a hard copy of the FDA Medication Guide for
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107	107	1 the psychotropic drug being prescribed.
108	108	2 (7) Medicaid is a state and federally funded program
109	109	3 that provides essential healthcare services to vulnerable
110	110	4 populations, including children and adolescents. It should
111	111	5 be required to distribute the FDA Medication Guides to
112	112	6 ensure recipients and their guardians are fully informed
113	113	7 of the risks and potential adverse effects of psychotropic
114	114	8 medications, thereby supporting informed consent and
115	115	9 promoting patient safety.
116	116	10 (8) A reliable system for parents and caregivers to
117	117	11 report adverse drug reactions to psychotropic drugs is
118	118	12 essential to help Medicaid agencies and legislators
119	119	13 monitor and assess the frequency, severity, and impact of
120	120	14 such reactions within the public sector.
121	121	15 (9) The absence of an accessible, Medicaid-funded
122	122	16 reporting mechanism for drug side effects limits the
123	123	17 ability to identify and address these risks effectively,
124	124	18 compromising the safety of children and adolescents.
125	125	19 (10) Medicaid is the primary payer for psychotropic
126	126	20 medications prescribed to children and adolescents in the
127	127	21 public sector, including for off-label use in children as
128	128	22 young as 0-5 years, making it directly responsible for
129	129	23 ensuring the safety and monitoring of these prescriptions.
130	130	24 (11) Adverse drug reactions (ADRs) to psychotropic
131	131	25 medications can have significant physical, psychological,
132	132	26 and developmental impacts on children, requiring timely
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143	143	1 identification and response to mitigate harm.
144	144	2 (12) The establishment of an online ADR reporting
145	145	3 system would enable the State's Medicaid program to
146	146	4 fulfill its duty of care by providing a mechanism to
147	147	5 collect critical safety data, support evidence-based
148	148	6 decision-making, and comply with its responsibility to
149	149	7 protect public health.
150	150	8 (13) Funding this reporting system aligns with the
151	151	9 State's Medicaid program's obligations under federal law
152	152	10 to monitor and improve the quality of care provided to its
153	153	11 beneficiaries, especially vulnerable pediatric
154	154	12 populations, and would facilitate oversight and
155	155	13 accountability for the use of public funds in prescribing
156	156	14 psychotropic medications.
157	157	15 (14) The provisions of this Act are established to
158	158	16 address these findings and enhance oversight, informed
159	159	17 consent, and accountability in psychotropic drug
160	160	18 prescriptions for children under the State's Medicaid
161	161	19 program.
162	162	20 Section 10. Definitions. As used in this Act:
163	163	21 "Adverse drug reaction" or "ADR" means any unintended
164	164	22 harmful reaction to a psychotropic drug.
165	165	23 "Department" means the Department of Healthcare and Family
166	166	24 Services.
167	167	25 "FDA Medication Guides" means handouts accompanying
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178	178	1 certain prescription medications with significant safety
179	179	2 concerns, approved by the U.S. Food and Drug Administration
180	180	3 (FDA), to inform patients and caregivers about risks, side
181	181	4 effects, and proper usage.
182	182	5 "Medical care providers" means any licensed health
183	183	6 professionals authorized to prescribe medication under the
184	184	7 State's Medicaid program.
185	185	8 "Online Reporting System" means a web-based platform
186	186	9 through which Medicaid beneficiaries or their guardians can
187	187	10 report ADRs related to psychotropic drugs.
188	188	11 "Psychotropic drugs" means medications that affect the
189	189	12 mind, emotions, or behavior, including, but not limited to,
190	190	13 stimulants, antidepressants, antipsychotics, and other
191	191	14 behavioral drugs, authorized or funded under the State's
192	192	15 Medicaid program.
193	193	16 Section 15. Informed consent requirements.
194	194	17 (a) Distribution of FDA Medication Guides:
195	195	18 (1) Medical care providers prescribing psychotropic
196	196	19 drugs to children under the State's Medicaid program must
197	197	20 provide FDA Medication Guides to parents or legal
198	198	21 guardians before issuing a prescription.
199	199	22 (2) The Medication Guides must be printed and reviewed
200	200	23 with the parent or legal guardian, explaining:
201	201	24 (A) FDA-identified risks of the medication,
202	202	25 including pediatric-specific warnings.
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213	213	1 (B) Signs of potential side effects and adverse
214	214	2 drug reactions detailed in the Medication Guide.
215	215	3 (b) Written and signed informed consent. Before
216	216	4 prescribing a psychotropic drug, written informed consent must
217	217	5 be obtained from the parent or legal guardian. The consent
218	218	6 must:
219	219	7 (1) Be signed by the parent or legal guardian,
220	220	8 confirming that they:
221	221	9 (A) Have received and reviewed the FDA Medication
222	222	10 Guide.
223	223	11 (B) Understand the associated risks and side
224	224	12 effects.
225	225	13 (2) Be kept on file by the medical care provider, with
226	226	14 a copy provided to the parent or legal guardian.
227	227	15 Section 20. Medicaid establishment of an Adverse Drug
228	228	16 Reaction (ADR) Online Reporting System.
229	229	17 (a) Adverse drug reaction online reporting system. The
230	230	18 Department of Healthcare and Family Services shall, within 12
231	231	19 months after the effective date of this Act, develop and
232	232	20 maintain a secure online reporting system for adverse drug
233	233	21 reactions related to psychotropic drugs prescribed to children
234	234	22 and adolescents. The system shall include the below free-text
235	235	23 fields and drop-down menus for categorizing the type of drug,
236	236	24 the nature of the adverse reaction, and the severity level.
237	237	25 These features shall streamline the reporting process by
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248	248	1 simplifying user input, ensuring faster processing, and
249	249	2 reducing errors for a secure online system, which will allow
250	250	3 the Department of Healthcare and Family Services to provide
251	251	4 legislators with summaries of the adverse reactions being
252	252	5 reported.
253	253	6 (1) Name of Patient (free-text field)
254	254	7 (required)
255	255	8 (2) Age of Patient (drop-down menu)
256	256	9 (required)
257	257	10 (3) Class of Psychotropic Drug (drop-down menu)
258	258	11 (optional to skip if the reporter doesn't know the
259	259	12 category)
260	260	13 (A) Antidepressants.
261	261	14 (B) Antipsychotics.
262	262	15 (C) Mood Stabilizers.
263	263	16 (D) Stimulants.
264	264	17 (E) Anti-anxiety drugs and Sedatives.
265	265	18 (F) Hypnotics.
266	266	19 (4) Name of Drug (free-text field)
267	267	20 (required)
268	268	21 (5) Adverse Reaction Category (drop-down menu)
269	269	22 (required)
270	270	23 (A) Physical Reaction:
271	271	24 (i) Gastrointestinal issues (nausea, vomiting,
272	272	25 diarrhea, constipation).
273	273	26 (ii) Neurological symptoms (dizziness,
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284	284	1 headaches, seizures, tremors).
285	285	2 (iii) Cardiovascular symptoms (increased heart
286	286	3 rate, blood pressure changes).
287	287	4 (iv) Endocrine/metabolic effects (weight
288	288	5 changes, hormonal imbalances).
289	289	6 (v) Allergic reactions (rash, hives,
290	290	7 anaphylaxis).
291	291	8 (B) Psychological Reaction:
292	292	9 (i) Mood changes (irritability, depression,
293	293	10 euphoria).
294	294	11 (ii) Anxiety or panic attacks.
295	295	12 (iii) Hallucinations or delusions.
296	296	13 (iv) Agitation or restlessness.
297	297	14 (v) Suicidal thoughts or behaviors.
298	298	15 (C) Behavioral Reaction:
299	299	16 (i) Sleep disturbances (insomnia,
300	300	17 hypersomnia).
301	301	18 (ii) Increased aggression or hostility.
302	302	19 (iii) Manic behaviors.
303	303	20 (iv) Cognitive impairments (memory loss,
304	304	21 confusion).
305	305	22 (v) Self-harm.
306	306	23 (vi) Disassociation.
307	307	24 (D) Other (free-text field)
308	308	25 (6) Severity level (drop-down menu)
309	309	26 (required)
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320	320	1 (A) Mild.
321	321	2 (B) Moderate.
322	322	3 (C) Severe.
323	323	4 (7) Name of Person Reporting (free-text field)
324	324	5 (required)
325	325	6 (8) Relation of Person Reporting (drop-down menu)
326	326	7 (required)
327	327	8 (A) Parent.
328	328	9 (B) Foster Parent.
329	329	10 (C) Relative.
330	330	11 (D) Legal Guardian.
331	331	12 (E) Case Worker.
332	332	13 (F) Social Worker.
333	333	14 (G) Direct Care Staff.
334	334	15 (H) Other (free-text field).
335	335	16 (9) Email Address of Person Reporting (free-text
336	336	17 field)
337	337	18 (optional, to facilitate any needed follow-up)
338	338	19 (10) Phone Number of Person Reporting (free-text
339	339	20 field)
340	340	21 (optional, to facilitate any needed follow-up)
341	341	22 (b) Adverse drug reaction reporting requirements. The
342	342	23 Department shall compile and submit quarterly reports
343	343	24 summarizing ADR data related to psychotropic drugs
344	344	25 administered to children and adolescents to the legislative
345	345	26 committees overseeing Medicaid funding. These reports shall
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356	356	1 include:
357	357	2 (1) The number of ADRs reported broken down by age
358	358	3 group.
359	359	4 (2) The severity level of ADRs reported.
360	360	5 (3) A breakdown of ADRs by Adverse Reaction Category
361	361	6 and severity of reactions detailing the number of
362	362	7 incidents for each category of reaction and severity.
363	363	8 (c) Legislative oversight. Legislative committees shall
364	364	9 review ADR reports related to psychotropic drugs during
365	365	10 Medicaid budget hearings and program reviews and may recommend
366	366	11 actions to improve medication safety.
367	367	12 (d) Implementation. The Department shall allocate funds to
368	368	13 establish and maintain the ADR online reporting system
369	369	14 specifically for psychotropic drugs and may seek additional
370	370	15 funding as needed.
371	371	16 Section 25. Penalties for medical care provider
372	372	17 noncompliance with medication guide distribution. Suspension
373	373	18 of Medicaid reimbursement. Medical care providers failing to
374	374	19 comply with the signed informed consent form on the Medication
375	375	20 Guide may face penalties, including suspension of Medicaid
376	376	21 reimbursements.
377	377	22 Section 30. Penalty for Department noncompliance. If the
378	378	23 Department fails to submit the required quarterly ADR reports
379	379	24 to the appropriate legislative committees within the specified
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390	390	1 timeframe, the following penalties shall apply:
391	391	2 (1) Monetary penalty. The Department shall incur a
392	392	3 monetary fine for each quarter of noncompliance, with the
393	393	4 fine amount increasing for subsequent violations. The fine
394	394	5 shall be deposited into the Medicaid Oversight and Safety
395	395	6 Measures Fund, a special fund created in the State
396	396	7 treasury for the sole purpose of improving Medicaid
397	397	8 oversight and safety measures.
398	398	9 (2) Reduction in Medicaid funding. The State's
399	399	10 Medicaid program shall face a reduction in its funding
400	400	11 allocation for the following fiscal quarter until full
401	401	12 compliance is demonstrated, including the timely
402	402	13 submission of all required ADR reports.
403	403	14 (3) Oversight review. The Governor or relevant State
404	404	15 oversight body shall initiate a formal review of the
405	405	16 Department's operations and reporting procedures, which
406	406	17 may result in further corrective actions, including the
407	407	18 appointment of an external auditor to ensure the accurate
408	408	19 and timely reporting of ADR data.
409	409	20 Section 35. Transparency and accountability reports. The
410	410	21 Department must submit annual reports to the General Assembly
411	411	22 summarizing implementation efforts, compliance statistics, and
412	412	23 the impact of this Act, including fiscal analysis and health
413	413	24 outcomes.
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424	424	1 Section 45. The State Finance Act is amended by adding
425	425	2 Section 5.1030 as follows:
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