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AN ACT relating to psychotropic drugs. 1
WHEREAS, in 2023, Kentucky's Medicaid program statistics showed 89,200 2
children and adolescents under the age of 18 being prescribed psychotropic drugs, 3
including 8,386 under the age of six; and 4
WHEREAS, the administration of nearly every psychotropic drug to children under 5
the age of six is off-label, meaning the drug is prescribed for age groups not approved by 6
the United States Food and Drug Administration (FDA); and 7
WHEREAS, psychotropic drugs, including stimulants, antidepressants, 8
antipsychotics, and other behavioral drugs, are being prescribed to children using 9
Medicaid funding and are documented by the FDA to include severe side effects, 10
including but not limited to addiction, suicidal ideation, aggression, hallucinations, 11
cardiovascular events, stunted growth, and developmental concerns; and 12
WHEREAS, parents and caregivers are frequently not informed of the FDA-13
documented risks associated with the psychotropics being prescribed, including the 14
pediatric risks; and 15
WHEREAS, 21 C.F.R. sec. 208.20 establishes the requirements for an FDA 16
Medication Guide to provide easily understandable information about the risks and side 17
effects of prescription drugs for the average consumer, including parents and caregivers; 18
and 19
WHEREAS, according to the 21 C.F.R. sec. 208.20, a Medications Guide must 20
detail "the particular serious and significant public health concern that has created the 21
need for the Medication Guide"; note any known "pediatric risk"; include the risk of 22
"patients developing dependence on the drug products"; use a font size no smaller than 23
ten-point; be written in "nontechnical, understandable language"; and "not be 24
promotional in tone or content"; and 25
WHEREAS, to effectively monitor the effects of psychotropic drugs prescribed to 26
children and adolescents, particularly the FDA-cited "pediatric effects," parents and 27 UNOFFICIAL COPY 25 RS BR 1619
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caregivers must be given a hard copy of the FDA Medication Guide for the psychotropic 1
drug being prescribed; and 2
WHEREAS, Medicaid is a state and federally funded program that provides 3
essential healthcare services to vulnerable populations, including children and 4
adolescents, it should be required to distribute the FDA Medication Guide to ensure 5
recipients and their guardians are fully informed of the risks and potential adverse effects 6
of psychotropic medications, thereby supporting informed consent and promoting patient 7
safety; and 8
WHEREAS, a reliable system for parents and caregivers to report adverse drug 9
reactions to psychotropic drugs is essential to help Medicaid agencies and legislators 10
monitor and assess the frequency, severity, and impact of such reactions within the public 11
sector; and 12
WHEREAS, the absence of an accessible, Medicaid-funded reporting mechanism 13
for drug side-effects limits the ability to identify and address these risks effectively, 14
compromising the safety of children and adolescents; and 15
WHEREAS, Medicaid is the primary payer for psychotropic medications prescribed 16
to children and adolescents in the public sector, including for off-label use in children 17
under the age of six, making it directly responsible for ensuring the safety and monitoring 18
of these prescriptions; and 19
WHEREAS, an adverse drug reaction (ADR) to psychotropic medications can have 20
significant physical, psychological, and developmental impacts on children, requiring 21
timely identification and response to mitigate harm; and 22
WHEREAS, the establishment of an online ADR reporting system would enable 23
Medicaid to fulfill its duty of care by providing a mechanism to collect critical safety 24
data, support evidence-based decision-making, and comply with its responsibility to 25
protect public health; and 26
WHEREAS, funding this reporting system aligns with Medicaid's obligations under 27 UNOFFICIAL COPY 25 RS BR 1619
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federal law to monitor and improve the quality of care provided to its oversight and 1
accountability for the use of public funds in prescribing psychotropic medications; and 2
WHEREAS, the provisions of this Act are established to address these finding and 3
enhance oversight, informed consent, and accountability for children under the Medicaid 4
program; 5
NOW, THEREFORE, 6
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 7
ď˘SECTION 1. A NEW SECTION OF KRS CHAPTER 205 IS CREATED TO 8
READ AS FOLLOWS: 9
(1) As used in this section: 10
(a) "Adverse drug reaction" or "ADR" means any unintended harmful 11
reaction or side effect to a psychotropic drug; 12
(b) "Child" means an individual under eighteen (18) years of age; 13
(c) "Medicaid-enrolled provider" means any licensed health professional 14
authorized to prescribe medication to Medicaid beneficiaries; 15
(d) "Medication Guide" means handouts accompanying certain prescription 16
medications with significant safety concerns as required under 21 C.F.R. 17
sec. 208.20; 18
(e) "Online reporting system" means a web-based platform through which 19
Medicaid beneficiaries or their parents or guardians can report ADRs 20
related to psychotropic drugs; and 21
(f) "Psychotropic drugs": 22
1. Means medications that affect the mind, emotions, or behavior of a 23
person, including but not limited to stimulants, antidepressants, 24
antipsychotics; and 25
2. Is limited to psychotropic drugs included on the Medicaid uniform 26
preferred drug list. 27 UNOFFICIAL COPY 25 RS BR 1619
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(2) (a) A Medicaid-enrolled provider prescribing psychotropic drugs to a child 1
covered by Medicaid shall provide a Medication Guide to the child's parents 2
or legal guardians before issuing a prescription. 3
(b) The Medication Guide shall be printed and reviewed with the parent or 4
legal guardian to inform them of: 5
1. FDA-identified side effects and cautionary monitoring citations of 6
additional potential risks; 7
2. Any FDA black box warning detailing serious or life-threatening 8
risks; and 9
3. Pediatric-specific side effects or warnings related to children and 10
teens. 11
(3) A Medicaid-enrolled provider shall obtain written informed consent from the 12
parent or legal guardian before prescribing a psychotropic drug to a child 13
covered by Medicaid. The consent shall be: 14
(a) Signed by the parent or legal guardian, confirming that he or she: 15
1. Has received and reviewed the Medication Guide; and 16
2. Understands the associated risks and side effects of the psychotropic 17
drug; and 18
(b) Kept on file by the Medicaid-enrolled provider, with a copy provided to the 19
parent or legal guardian. 20
(4) (a) The cabinet shall, within twelve (12) months after the effective date of this 21
Act, develop and maintain a secure online reporting system of ADRs related 22
to psychotropic drugs prescribed to children and adolescents covered by 23
Medicaid. 24
(b) The system required under paragraph (a) of this subsection shall include 25
free text fields for the: 26
1. Name of patient; 27 UNOFFICIAL COPY 25 RS BR 1619
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2. Name of medication; 1
3. Name of the person reporting; 2
4. Email address of the person reporting; and 3
5. Phone number of the person reporting. 4
(b) The System required under paragraph (a) of this subsection shall include 5
drop-down menus for the following: 6
1. Age of patient; 7
2. Class of psychotropic drug, including 8
a. Antidepressants; 9
b. Antipsychotics; 10
c. Mood stabilizers; 11
d. Stimulants; 12
e. Anti-anxiety drugs and sedatives; 13
f. Hypnotics; and 14
g. Unknown; 15
3. Type of adverse reaction experienced or observed, including: 16
a. Physical reaction, including: 17
i. Gastrointestinal issues, including nausea, vomiting, 18
diarrhea, or constipation; 19
ii. Neurological symptoms, including dizziness, headaches, 20
seizures, or tremors; 21
iii. Cardiovascular symptoms, including increased heart rate 22
or blood pressure changes; and 23
iv. Allergic reactions, rash, hives, or anaphylaxis; 24
b. Psychological reaction experienced or observed, including: 25
i. Mood changes, including irritability, depression, or 26
euphoria; 27 UNOFFICIAL COPY 25 RS BR 1619
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ii. Anxiety or panic attacks; 1
iii. Hallucinations or delusions; 2
iv. Agitation or restlessness; and 3
v. Suicidal thoughts or behaviors; and 4
c. Behavioral reaction experienced or observed, including: 5
i. Sleep disturbances, including insomnia or hypersomnia; 6
ii. Increased aggression or hostility; 7
iii. Manic behaviors; 8
iv. Cognitive impairments, including memory loss or 9
confusion; 10
v. Self-harm; and 11
vi. Disassociation; and 12
4. Severity level of reaction, including: 13
a. Mild; 14
b. Moderate; and 15
c. Severe; and 16
5. Relation of person reporting, including: 17
a. Parent; 18
b. Foster parent; 19
c. Relative; 20
d. Legal guardian; 21
e. Case worker; 22
f. Social worker; and 23
g. Direct care staff. 24
(5) (a) The cabinet shall compile and submit a report no later than November 1, 25
2026, and each November 1 thereafter, summarizing ADR data related 26
to psychotropic drugs administered to children and adolescents 27 UNOFFICIAL COPY 25 RS BR 1619
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covered by Medicaid to the Legislative Research Commission for 1
referral to the Interim Joint Committees on Health Services and 2
Families and Children. 3
(b) The report shall include: 4
1. The number of ADRs reported categorized by patient age; 5
2. The totals of various severity levels of ADRs reported; and 6
2. A breakdown of ADRs by type of adverse reactions detailing the 7
number of incidents for each category. 8
(6) The cabinet shall submit a report no later than November 1, 2026, and each 9
November 1 thereafter summarizing implementation efforts and compliance 10
statistics of Medicaid-enrolled providers to the Legislative Research Commission 11
for referral to the Interim Joint Committees on Health Services and Families and 12
Children. 13
(7) Medicaid-enrolled providers failing to comply with the provisions of subsections 14
(2) and (3) of this section may face penalties, including but not limited to 15
termination of Medicaid enrollment. 16
(8) The cabinet shall promulgate administrative regulations in accordance with KRS 17
Chapter 13A to implement this section including the establishment of 18
enforcement mechanisms and appropriate penalties for violations. 19