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
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
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
LRB104 10052 KTG 20123 b
A BILL FOR
HB2512LRB104 10052 KTG 20123 b HB2512 LRB104 10052 KTG 20123 b
HB2512 LRB104 10052 KTG 20123 b
1 AN ACT concerning health care.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 1. Short title. This Act may be cited as the
5 Accountability in Psychotropic Drug Prescriptions for Children
6 Under Medicaid Act.
7 Section 5. Legislative findings. The General Assembly
8 finds the following:
9 (1) In 2023, Illinois' Medicaid program statistics
10 showed 96,841 children and adolescents aged 0-17 being
11 prescribed psychotropic drugs, including 7,227 children
12 aged 0-5.
13 (2) The administration of nearly every psychotropic
14 drug to children aged 0-5 is off-label, meaning the drugs
15 are being prescribed for age groups not approved by the
16 U.S. Food and Drug Administration (FDA).
17 (3) Psychotropic drugs, including stimulants,
18 antidepressants, antipsychotics, and other behavioral
19 drugs, are being prescribed to children using Medicaid
20 funding and are documented by the FDA to include severe
21 side effects, including, but not limited to, addiction,
22 suicidal ideation, aggression, hallucinations,
23 cardiovascular events, stunted growth, and developmental
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
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
LRB104 10052 KTG 20123 b
A BILL FOR
New Act
30 ILCS 105/5.1030 new
LRB104 10052 KTG 20123 b
HB2512 LRB104 10052 KTG 20123 b
HB2512- 2 -LRB104 10052 KTG 20123 b HB2512 - 2 - LRB104 10052 KTG 20123 b
HB2512 - 2 - LRB104 10052 KTG 20123 b
1 concerns.
2 (4) Parents and caregivers are frequently not informed
3 of the FDA-documented risks associated with the
4 psychotropics being prescribed, including the pediatric
5 risks.
6 (5) Section 208.20 of Title 21 of the United States
7 Code of Federal Regulations (CFR) establishes the
8 requirement for FDA Medication Guides to provide easily
9 understandable information about the risks and side
10 effects of prescription drugs for the average consumer,
11 including parents and caregivers. According to federal
12 regulations, Medication Guides must:
13 (A) Detail "the particular serious and significant
14 public health concern that has created the need for
15 the Medication Guide".
16 (B) Note any known "pediatric risks".
17 (C) Include the risk of "patients developing
18 dependence on the drug product".
19 (D) Use a font size no smaller than 10-point.
20 (E) Be written in "nontechnical, understandable
21 language".
22 (F) "Not be promotional in tone or content".
23 (6) To effectively monitor the effects of psychotropic
24 drugs prescribed to children and adolescents, particularly
25 the FDA-cited "pediatric effects", parents and caregivers
26 must be given a hard copy of the FDA Medication Guide for
HB2512 - 2 - LRB104 10052 KTG 20123 b
HB2512- 3 -LRB104 10052 KTG 20123 b HB2512 - 3 - LRB104 10052 KTG 20123 b
HB2512 - 3 - LRB104 10052 KTG 20123 b
1 the psychotropic drug being prescribed.
2 (7) Medicaid is a state and federally funded program
3 that provides essential healthcare services to vulnerable
4 populations, including children and adolescents. It should
5 be required to distribute the FDA Medication Guides to
6 ensure recipients and their guardians are fully informed
7 of the risks and potential adverse effects of psychotropic
8 medications, thereby supporting informed consent and
9 promoting patient safety.
10 (8) A reliable system for parents and caregivers to
11 report adverse drug reactions to psychotropic drugs is
12 essential to help Medicaid agencies and legislators
13 monitor and assess the frequency, severity, and impact of
14 such reactions within the public sector.
15 (9) The absence of an accessible, Medicaid-funded
16 reporting mechanism for drug side effects limits the
17 ability to identify and address these risks effectively,
18 compromising the safety of children and adolescents.
19 (10) Medicaid is the primary payer for psychotropic
20 medications prescribed to children and adolescents in the
21 public sector, including for off-label use in children as
22 young as 0-5 years, making it directly responsible for
23 ensuring the safety and monitoring of these prescriptions.
24 (11) Adverse drug reactions (ADRs) to psychotropic
25 medications can have significant physical, psychological,
26 and developmental impacts on children, requiring timely
HB2512 - 3 - LRB104 10052 KTG 20123 b
HB2512- 4 -LRB104 10052 KTG 20123 b HB2512 - 4 - LRB104 10052 KTG 20123 b
HB2512 - 4 - LRB104 10052 KTG 20123 b
1 identification and response to mitigate harm.
2 (12) The establishment of an online ADR reporting
3 system would enable the State's Medicaid program to
4 fulfill its duty of care by providing a mechanism to
5 collect critical safety data, support evidence-based
6 decision-making, and comply with its responsibility to
7 protect public health.
8 (13) Funding this reporting system aligns with the
9 State's Medicaid program's obligations under federal law
10 to monitor and improve the quality of care provided to its
11 beneficiaries, especially vulnerable pediatric
12 populations, and would facilitate oversight and
13 accountability for the use of public funds in prescribing
14 psychotropic medications.
15 (14) The provisions of this Act are established to
16 address these findings and enhance oversight, informed
17 consent, and accountability in psychotropic drug
18 prescriptions for children under the State's Medicaid
19 program.
20 Section 10. Definitions. As used in this Act:
21 "Adverse drug reaction" or "ADR" means any unintended
22 harmful reaction to a psychotropic drug.
23 "Department" means the Department of Healthcare and Family
24 Services.
25 "FDA Medication Guides" means handouts accompanying
HB2512 - 4 - LRB104 10052 KTG 20123 b
HB2512- 5 -LRB104 10052 KTG 20123 b HB2512 - 5 - LRB104 10052 KTG 20123 b
HB2512 - 5 - LRB104 10052 KTG 20123 b
1 certain prescription medications with significant safety
2 concerns, approved by the U.S. Food and Drug Administration
3 (FDA), to inform patients and caregivers about risks, side
4 effects, and proper usage.
5 "Medical care providers" means any licensed health
6 professionals authorized to prescribe medication under the
7 State's Medicaid program.
8 "Online Reporting System" means a web-based platform
9 through which Medicaid beneficiaries or their guardians can
10 report ADRs related to psychotropic drugs.
11 "Psychotropic drugs" means medications that affect the
12 mind, emotions, or behavior, including, but not limited to,
13 stimulants, antidepressants, antipsychotics, and other
14 behavioral drugs, authorized or funded under the State's
15 Medicaid program.
16 Section 15. Informed consent requirements.
17 (a) Distribution of FDA Medication Guides:
18 (1) Medical care providers prescribing psychotropic
19 drugs to children under the State's Medicaid program must
20 provide FDA Medication Guides to parents or legal
21 guardians before issuing a prescription.
22 (2) The Medication Guides must be printed and reviewed
23 with the parent or legal guardian, explaining:
24 (A) FDA-identified risks of the medication,
25 including pediatric-specific warnings.
HB2512 - 5 - LRB104 10052 KTG 20123 b
HB2512- 6 -LRB104 10052 KTG 20123 b HB2512 - 6 - LRB104 10052 KTG 20123 b
HB2512 - 6 - LRB104 10052 KTG 20123 b
1 (B) Signs of potential side effects and adverse
2 drug reactions detailed in the Medication Guide.
3 (b) Written and signed informed consent. Before
4 prescribing a psychotropic drug, written informed consent must
5 be obtained from the parent or legal guardian. The consent
6 must:
7 (1) Be signed by the parent or legal guardian,
8 confirming that they:
9 (A) Have received and reviewed the FDA Medication
10 Guide.
11 (B) Understand the associated risks and side
12 effects.
13 (2) Be kept on file by the medical care provider, with
14 a copy provided to the parent or legal guardian.
15 Section 20. Medicaid establishment of an Adverse Drug
16 Reaction (ADR) Online Reporting System.
17 (a) Adverse drug reaction online reporting system. The
18 Department of Healthcare and Family Services shall, within 12
19 months after the effective date of this Act, develop and
20 maintain a secure online reporting system for adverse drug
21 reactions related to psychotropic drugs prescribed to children
22 and adolescents. The system shall include the below free-text
23 fields and drop-down menus for categorizing the type of drug,
24 the nature of the adverse reaction, and the severity level.
25 These features shall streamline the reporting process by
HB2512 - 6 - LRB104 10052 KTG 20123 b
HB2512- 7 -LRB104 10052 KTG 20123 b HB2512 - 7 - LRB104 10052 KTG 20123 b
HB2512 - 7 - LRB104 10052 KTG 20123 b
1 simplifying user input, ensuring faster processing, and
2 reducing errors for a secure online system, which will allow
3 the Department of Healthcare and Family Services to provide
4 legislators with summaries of the adverse reactions being
5 reported.
6 (1) Name of Patient (free-text field)
7 (required)
8 (2) Age of Patient (drop-down menu)
9 (required)
10 (3) Class of Psychotropic Drug (drop-down menu)
11 (optional to skip if the reporter doesn't know the
12 category)
13 (A) Antidepressants.
14 (B) Antipsychotics.
15 (C) Mood Stabilizers.
16 (D) Stimulants.
17 (E) Anti-anxiety drugs and Sedatives.
18 (F) Hypnotics.
19 (4) Name of Drug (free-text field)
20 (required)
21 (5) Adverse Reaction Category (drop-down menu)
22 (required)
23 (A) Physical Reaction:
24 (i) Gastrointestinal issues (nausea, vomiting,
25 diarrhea, constipation).
26 (ii) Neurological symptoms (dizziness,
HB2512 - 7 - LRB104 10052 KTG 20123 b
HB2512- 8 -LRB104 10052 KTG 20123 b HB2512 - 8 - LRB104 10052 KTG 20123 b
HB2512 - 8 - LRB104 10052 KTG 20123 b
1 headaches, seizures, tremors).
2 (iii) Cardiovascular symptoms (increased heart
3 rate, blood pressure changes).
4 (iv) Endocrine/metabolic effects (weight
5 changes, hormonal imbalances).
6 (v) Allergic reactions (rash, hives,
7 anaphylaxis).
8 (B) Psychological Reaction:
9 (i) Mood changes (irritability, depression,
10 euphoria).
11 (ii) Anxiety or panic attacks.
12 (iii) Hallucinations or delusions.
13 (iv) Agitation or restlessness.
14 (v) Suicidal thoughts or behaviors.
15 (C) Behavioral Reaction:
16 (i) Sleep disturbances (insomnia,
17 hypersomnia).
18 (ii) Increased aggression or hostility.
19 (iii) Manic behaviors.
20 (iv) Cognitive impairments (memory loss,
21 confusion).
22 (v) Self-harm.
23 (vi) Disassociation.
24 (D) Other (free-text field)
25 (6) Severity level (drop-down menu)
26 (required)
HB2512 - 8 - LRB104 10052 KTG 20123 b
HB2512- 9 -LRB104 10052 KTG 20123 b HB2512 - 9 - LRB104 10052 KTG 20123 b
HB2512 - 9 - LRB104 10052 KTG 20123 b
1 (A) Mild.
2 (B) Moderate.
3 (C) Severe.
4 (7) Name of Person Reporting (free-text field)
5 (required)
6 (8) Relation of Person Reporting (drop-down menu)
7 (required)
8 (A) Parent.
9 (B) Foster Parent.
10 (C) Relative.
11 (D) Legal Guardian.
12 (E) Case Worker.
13 (F) Social Worker.
14 (G) Direct Care Staff.
15 (H) Other (free-text field).
16 (9) Email Address of Person Reporting (free-text
17 field)
18 (optional, to facilitate any needed follow-up)
19 (10) Phone Number of Person Reporting (free-text
20 field)
21 (optional, to facilitate any needed follow-up)
22 (b) Adverse drug reaction reporting requirements. The
23 Department shall compile and submit quarterly reports
24 summarizing ADR data related to psychotropic drugs
25 administered to children and adolescents to the legislative
26 committees overseeing Medicaid funding. These reports shall
HB2512 - 9 - LRB104 10052 KTG 20123 b
HB2512- 10 -LRB104 10052 KTG 20123 b HB2512 - 10 - LRB104 10052 KTG 20123 b
HB2512 - 10 - LRB104 10052 KTG 20123 b
1 include:
2 (1) The number of ADRs reported broken down by age
3 group.
4 (2) The severity level of ADRs reported.
5 (3) A breakdown of ADRs by Adverse Reaction Category
6 and severity of reactions detailing the number of
7 incidents for each category of reaction and severity.
8 (c) Legislative oversight. Legislative committees shall
9 review ADR reports related to psychotropic drugs during
10 Medicaid budget hearings and program reviews and may recommend
11 actions to improve medication safety.
12 (d) Implementation. The Department shall allocate funds to
13 establish and maintain the ADR online reporting system
14 specifically for psychotropic drugs and may seek additional
15 funding as needed.
16 Section 25. Penalties for medical care provider
17 noncompliance with medication guide distribution. Suspension
18 of Medicaid reimbursement. Medical care providers failing to
19 comply with the signed informed consent form on the Medication
20 Guide may face penalties, including suspension of Medicaid
21 reimbursements.
22 Section 30. Penalty for Department noncompliance. If the
23 Department fails to submit the required quarterly ADR reports
24 to the appropriate legislative committees within the specified
HB2512 - 10 - LRB104 10052 KTG 20123 b
HB2512- 11 -LRB104 10052 KTG 20123 b HB2512 - 11 - LRB104 10052 KTG 20123 b
HB2512 - 11 - LRB104 10052 KTG 20123 b
1 timeframe, the following penalties shall apply:
2 (1) Monetary penalty. The Department shall incur a
3 monetary fine for each quarter of noncompliance, with the
4 fine amount increasing for subsequent violations. The fine
5 shall be deposited into the Medicaid Oversight and Safety
6 Measures Fund, a special fund created in the State
7 treasury for the sole purpose of improving Medicaid
8 oversight and safety measures.
9 (2) Reduction in Medicaid funding. The State's
10 Medicaid program shall face a reduction in its funding
11 allocation for the following fiscal quarter until full
12 compliance is demonstrated, including the timely
13 submission of all required ADR reports.
14 (3) Oversight review. The Governor or relevant State
15 oversight body shall initiate a formal review of the
16 Department's operations and reporting procedures, which
17 may result in further corrective actions, including the
18 appointment of an external auditor to ensure the accurate
19 and timely reporting of ADR data.
20 Section 35. Transparency and accountability reports. The
21 Department must submit annual reports to the General Assembly
22 summarizing implementation efforts, compliance statistics, and
23 the impact of this Act, including fiscal analysis and health
24 outcomes.
HB2512 - 11 - LRB104 10052 KTG 20123 b
HB2512- 12 -LRB104 10052 KTG 20123 b HB2512 - 12 - LRB104 10052 KTG 20123 b
HB2512 - 12 - LRB104 10052 KTG 20123 b
1 Section 45. The State Finance Act is amended by adding
2 Section 5.1030 as follows:
HB2512 - 12 - LRB104 10052 KTG 20123 b