H.B. 2163, 81st Legislature, Regular Session, 2009, required that the Texas Health and Human Services Commission (HHSC) conduct a study and submit a report by November 10, 2010, on the appropriateness and safety of providing antipsychotic medication through the Medicaid Vendor Drug Program to children younger than 16 years of age. This legislation was based on concerns regarding the increased use of these medications in Medicaid children during the past decade. Questions arose whether these medications are safe for children and whether prescribing them to children, particularly off label (without an approved indication by the United States Food and Drug Administration [FDA]), is appropriate.
This report provides a descriptive review of the current situation as documented in professional research literature and state, federal, and national public information. It relies on existing data and analyses. The literature review included more than 200 references published between 2000 and 2010.
The Conclusions and Options section of the report lists various options policymakers may want to consider to further encourage the appropriate prescribing of antipsychotic medications to children in Medicaid.
Key Components of Options to Consider Section:
HHSC is moving forward with initiatives related to two of these options (2 and 7).
1. Formally extend the Texas Parameters used for children in foster care to the overall Medicaid youth population in all service delivery models. Inform Medicaid prescribers that HHSC may use the Texas Parameters as a quality evaluation tool for record review for the overall Medicaid youth population.
2. Provide additional educational information to all Medicaid providers who treat children and adolescents and particularly to Medicaid providers who prescribe antipsychotic medications to a large number of Medicaid children as well as to those who most frequently prescribe outside of the Texas Parameters (e.g. prescribing two or more antipsychotics concurrently or prescribing them to very young children). Education also could include information on the importance of certain tests for monitoring for adverse effects in children prescribed antipsychotics (e.g. glucose testing, lipid screening), the elements of informed consent, and levels of evidence for off-label prescribing.
In August 2010, the Texas Medicaid Drug Utilization (DUR) Review Board, an advisory body comprised of physicians and pharmacists, requested that HHSC develop a retrospective intervention letter to targeted Medicaid prescribers on the use of atypical antipsychotics in children and the issues related to obesity and metabolic disorder with the use of these drugs. HHSC will develop a proposed letter to present to the DUR Board at its next meeting.
3. Consider extending the utilization review process of antipsychotic medications currently in place for the STAR Health population of children in foster care to the overall Medicaid youth population.
4. Specifically, extend the STAR Health class polypharmacy utilization review process for two or more antipsychotic medications prescribed concurrently to the overall Medicaid youth population.
5. Facilitate consultation, including via telemedicine, for non-psychiatrists serving Medicaid youth with mental health disorders, particularly in areas of the state where there are psychiatrist shortages.
6. Consider options to provide additional psychosocial services to Medicaid children. For example, add as a Medicaid benefit the procedure codes for integrated health care. This would extend statewide an HHSC pilot project that integrates licensed 10 mental health practitioners into pediatric primary care practices to provide preventive behavioral health services and facilitate referrals to a child psychiatrist as needed.
7. Review the availability (or lack thereof) of intensive behavioral interventions for the Medicaid population and restrictions on inpatient length of stay, which may encourage increased antipsychotic use due to the need to stabilize a child quickly.
8. Review the 36 practices contained in the June 2010 report titled “Antipsychotic Medication Use in Medicaid Children and Adolescents: Report and Resource Guide from a 16-State Study” for their applicability to the Texas Medicaid program.
9. Consider basing any prior authorization for antipsychotics on the “Criteria Indicating Need for Further Review of a Child’s Clinical Status” in the Texas Parameters (e.g. multiple antipsychotics prescribed concurrently, use in very young children). It would be appropriate for the DUR Board to advise HHSC on the establishment of any prior authorization criteria.
Based on the information in this report, HHSC is in the process of putting two new Vendor Drug Program prior authorization requirements in place – for any antipsychotic prescription to a Medicaid child under age 3 and for the third antipsychotic medication prescribed concurrently to any Medicaid recipient under age 18. The DUR Board will provide input on these prior authorization criteria and HHSC will need to modify the pharmacy claims system to implement them.
10. Provide information to help guide parents’ and patients’ decision-making as it relates to off-label prescribing of antipsychotic medications. This information should include all the elements necessary for a formal consent process, including the potential side effects related to these medications and the importance of diet, exercise, and followup appointments to monitor for adverse effects.
11. Consider institution of an adverse event reporting system through the STAR Health electronic health passport for children in foster care. The population is large enough to provide statistically valid information and the system is already in place so costs are minimized. Also, with the Department of Family and Protective Services (DFPS) as conservator, privacy concerns over starting a new database are minimized.
12. Consider funding a true research-style analytical study that will inform policy and provide methodology for developing statistically valid ongoing reports into the future. Potential study areas include the use of antipsychotics for the treatment of aggression and the mapping of diagnoses to antipsychotic use for various Medicaid youth subpopulations (such as youth in foster care, youth being served by mental health system, and the remaining Medicaid youth population). Another potential study area would be a long term outcome study to assess the health impact of the Texas Parameters on youth in foster care.
To read the complete report: http://www.hhsc.state.tx.us/reports/2010/Antipsychotic-Medications-Medicaid-1110.pdf