Foster Children: Additional Federal Guidance Could Help States Better Plan for Oversight of Psychotropic Medications Administered by Managed-Care Organizations
Published: 2014-04-28T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: In December 2011, GAO reported that foster children in selected states were prescribed psychotropic medications at rates higher than nonfoster children in Medicaid in 2008. GAO was asked to further examine instances of foster children being prescribed psychotropic medications.
For the five states included in GAO's 2011 report—Florida, Massachusetts, Michigan, Oregon, and Texas—this report: (1) assesses the extent that documentation supported the usage of psychotropic medication for selected cases; and (2) describes states' policies related to psychotropic medication and assesses HHS actions since GAO's 2011 report.
GAO contracted with two child psychiatrists who conduct mental-health research and work on issues related to foster care, to provide clinical evaluations of 24 cases that GAO selected from the population of foster children prescribed psychotropic drugs in GAO's 2011 report. The case selections were based, in part, on potential health risk indicators, and the findings are not generalizable. GAO obtained medical and child-welfare documentation spanning children's time in foster care, and redacted personally identifiable information prior to experts' review of cases. GAO also analyzed federal guidance and selected states' policies and interviewed federal and state officials.
section_title: What GAO Found
paragraphs: Two experts GAO contracted with reviewed foster and medical records for 24 cases in five selected states and found varying quality in the documentation supporting the use of psychotropic medications for children in foster care. Experts examined documentation related to several categories, such as (1) screening, assessment, and treatment planning; and (2) medication monitoring.
Screening, Assessment, and Treatment Planning. Experts' evaluation of this category included whether medical pediatric exams and evidence-based therapies—which are interventions shown to produce measureable improvements—were provided as needed, according to records. Experts found in 22 of 24 cases that medical pediatric exams were mostly supported by documentation. For example, in one case with mostly supporting documentation, experts found that a child with a history of behavioral and emotional problems had records documenting a medical pediatric exam and thorough psychological assessments, with comprehensive discussions of diagnostic issues and medication rationale. With regard to evidence-based therapies, experts found that 3 of 15 children who may have benefitted from such therapies were mostly provided such services, while 11 of 15 cases were scored as partial in this category, and in 1 of 15 cases there was no documentation that evidence-based therapies were provided.
Medication Monitoring. Experts' evaluation of this category included the appropriateness of medication dosage and the rationale for concurrent use of multiple medications, according to records. Experts found appropriateness of medication dosages was mostly supported by documentation in 13 of 24 cases and partially supported in the other 11 cases. The rationale for concurrent use of multiple medications was mostly supported in 5 of the 20 cases where multiple medications were used, but 14 of 20 cases included documentation that partially supported concurrent use, and 1 case did not include documentation to support concurrent use. For example, experts found for one case that a child was prescribed four psychotropic drugs concurrently, when nonmedication interventions could have been considered. The rationale for the actions taken was partially supported by documentation.
All of the five selected states—two of which pay health care providers directly through fee-for-service, and three of which use or are transitioning to a third-party managed-care organization (MCO) for prescription-drug benefits to some extent—have policies intended to address oversight of psychotropic medications for foster children. According to state officials, all five of the states require medical examinations for children in foster care. Since GAO's 2011 report, the Department of Health and Human Services' (HHS) Administration for Children and Families (ACF) has, among other things, worked with other federal agencies to provide informational webinars and technical guidance for states to improve oversight of psychotropic medications, but this guidance does not address third-party MCOs administering medications. Officials from two of the three states relying on MCOs described limited state planning for MCOs to monitor psychotropic medications. Because there are indications MCO use is increasing, additional HHS guidance that helps states implement oversight strategies within the context of a managed-care environment could help ensure appropriate monitoring of psychotropic medications prescribed to children in foster care.
section_title: What GAO Recommends
paragraphs: GAO recommends that HHS issue guidance to states regarding oversight of psychotropic medications prescribed to children in foster care through MCOs. HHS agreed with GAO's recommendation.

section_title: Letter
paragraphs: Children in foster care with mental-health conditions are among the  country’s most vulnerable populations, and there are concerns about  whether they have access to the most appropriate care for their  conditions. Early detection and treatment of emotional and behavioral  disturbances can improve a child’s symptoms and reduce potentially  detrimental effects on a child, such as difficulties with relationships,  dropping out of school, and involvement with the juvenile justice system.  Children with mental-health conditions, such as attention deficit  hyperactivity disorder (ADHD) or depression, can be treated with  psychosocial therapies (sessions with a provider designed to reduce  symptoms and improve functioning); psychotropic medication  (medications that affect mood, thought, or behavior); or a combination of  both.
Child mental-health advocates, providers, and researchers have  expressed concern about the increase in the prescription of psychotropic  medications to children, due in part to limited evidence available  regarding short- and long-term safety and efficacy for some types of  medications, particularly when used in combination. Some state Medicaid  and mental-health officials have expressed concern about the relatively  high rates of off-label use of antipsychotics, particularly among groups of  special concern such as children in foster care.
Several agencies in the Department of Health and Human Services  (HHS) have responsibilities related to children’s mental health. The  Administration for Children and Families (ACF) provides funding for and  oversees states’ child-welfare programs, which are responsible for  monitoring and coordinating mental-health services for children in foster  care, among other things. The Centers for Medicare & Medicaid Services  (CMS) oversees, and jointly finances with the states, Medicaid and the  State Children’s Health Insurance Program (CHIP), which provide health  coverage for low-income children. State Medicaid programs are required  by federal law to provide coverage for certain health services, which may  include mental-health services, for children through the Early and Periodic  Screening, Diagnostic, and Treatment (EPSDT) benefit. The Substance  Abuse and Mental Health Services Administration (SAMHSA) works to  increase the quality and availability of mental-health services, such as by  awarding grants that support the development of community-based  services for children with mental-health conditions, including children in  foster care.
Children in foster care who are enrolled in Medicaid may receive services  generally through one of two distinct service-delivery and financing  systems—managed care or fee-for-service. Under a managed-care  model, states contract with a managed-care organization (MCO) and  prospectively pay the plans a fixed monthly fee per patient to provide or  arrange for most health services, which may include prescription-drug  benefits. Plans, in turn, pay providers. In the traditional fee-for-service  delivery system, the Medicaid program reimburses providers directly and  on a retrospective basis for each service delivered.
In December 2011, we reported that children in foster care in the five  states analyzed were prescribed psychotropic medications at higher rates  than nonfoster children in Medicaid during 2008. According to research,  experts consulted, and certain federal and state officials interviewed as  part of our December 2011 report, this could be due in part to foster  children’s greater exposure to traumatic experiences, and the challenges  of coordinating their medical care and records due to frequent changes in  placement. Prescriptions to foster children in these states were also more  likely to have indicators of potential health risks. According to the experts  we consulted for our December 2011 report, no evidence supports the  concurrent use of five or more psychotropic medications in adults or  children, yet hundreds of both foster and nonfoster children in the five  states had such a drug regimen. Similarly, in our December 2011 report,  we found thousands of foster and nonfoster children were prescribed  doses higher than the maximum levels cited in guidelines developed by  the state of Texas, based on Food and Drug Administration (FDA)– approved or medical literature maximum dosages for children and  adolescents, which experts said increases the risk of adverse side effects  and does not typically increase the efficacy of the medications to any  significant extent. We also found that the monitoring programs of these  states for psychotropic medications provided to children in foster care  varied and fell short of best-principles guidelines published by the  American Academy of Child and Adolescent Psychiatry (AACAP). This  variation was expected because states set their own guidelines and HHS  had not endorsed specific measures for state oversight of psychotropic  prescriptions for children in foster care. In our December 2011 report we  recommended, and HHS agreed, to consider endorsing guidance for  states on best practices for overseeing psychotropic prescriptions for  children in foster care. The status of this recommendation is discussed  later in this report.
You asked us to continue our review of psychotropic medications  provided to children in foster care. This report (1) examines the extent to  which the use of psychotropic medications was supported by foster and  medical records for selected case studies of children in foster care who  were prescribed these medications; and (2) describes selected states’  policies or procedures intended to address oversight of psychotropic  medications, and assesses what, if any, actions HHS has taken to help  states oversee psychotropic medications prescribed to children in foster  care since our December 2011 report.
To examine the extent to which the use of psychotropic medications was  supported by foster and medical records, we selected a  nonrepresentative sample of 28 children in foster care covered by  Medicaid in Florida, Massachusetts, Michigan, Oregon, and Texas in  2008. Thus, the results of our case-study analysis are not generalizable  to the foster-child population within each of the five states we examined,  or to those of other states.
For each state included in our review, we randomly selected four cases;  each case represented one of the following four categories:  children prescribed any psychotropic medication during calendar year  2008 and in foster care as of January 2010;  children with prescriptions exceeding dosage guidelines developed by  the state of Texas, which were based on FDA-approved or medical  literature maximum dosages for children and adolescents, during  calendar year 2008 and in foster care as of January 2010;  children prescribed five or more medications concurrently during  calendar year 2008 and in foster care as of January 2010; and  children less than 1 year old prescribed any psychotropic medication  during calendar year 2008 and in foster care as of January 2010.
In addition to the 20 cases above, we also nonrandomly selected all  children less than 1 year old prescribed an ADHD, antipsychotic, or  antidepressant medication during calendar year 2008, totaling 8 infants.  These additional 8 cases were selected because, according to experts, it  is not standard practice to prescribe psychotropic medications to infants,  and these medications carry significant risks when prescribed to young  children.
After preliminary analysis, we excluded four selected cases from our  review. One case removed was a nonrandomly selected infant case in  which the prescription was identified as potential Medicaid fraud and the  case was referred to the state Medicaid Office of Inspector General for  follow up. Two other nonrandomly selected infant cases were removed  due to data-entry errors that indicated children received psychotropic  medications, when they had not. The fourth case removed was a  randomly selected infant case. In this case, the records provided did not  include any mental-health or prescription information for experts to  review. State officials confirmed the psychotropic medication prescribed  to the infant was for non-mental-health purposes. Thus, 24 cases were  included in our final case-file review.
To provide a clinical perspective on our cases, we contracted with two  child psychiatrists who are board certified in child and adolescent  psychiatry, have conducted clinical research regarding mental illness in  children, and who are working on issues related to psychotropic  medication use among children in foster care. For additional information  on experts and the criteria that informed our selection, see appendix I. To  review the cases, the two experts collaborated to develop categories that  are applicable to the administration of psychotropic medications, as  informed by AACAP guidelines and their clinical experience. The  categories include, but are not limited to, the quality of documentation  related to psychiatric evaluations, monitoring and efficacy of medications,  and changes in medication doses. GAO obtained medical and child- welfare documentation spanning the children’s time in foster care, and  redacted personally identifiable information prior to experts’ review of  cases. For each case, experts reviewed the child’s medical and foster  care information (such as case-file notes, medical history, and  prescriptions) covering the entire period the child was in foster care, and  provided an opinion on the categories reviewed, as well as a summary  narrative describing the facts and circumstances surrounding the child’s  use of psychotropic medication. Experts noted any potential issues  related to the use of psychotropic medications based on supporting  documentation, which was reviewed from a quantitative and qualitative  standpoint. The experts’ opinions are presented topically using ACF’s  program instructions regarding (1) screening, assessment, and treatment  planning; (2) medication monitoring; and (3) informed and shared  decision making as a framework to illustrate case findings.
We provided officials from selected states with copies of the experts’  preliminary case reviews to help ensure all available documentation was  included for experts’ evaluations and to allow state experts, including  experts in child and adolescent psychiatry, to review the expert case  descriptions. State officials were given an opportunity to provide  additional comments or documentation, and we incorporated their  comments into this report as appropriate.
To describe the five selected states’ policies or procedures intended to  provide oversight of psychotropic medications and determine what, if any,  actions HHS has taken to help states oversee psychotropic medications  prescribed to foster children since December 2011, we reviewed federal  statutes, regulations, and state policies related to the prescribing and  oversight of psychotropic medications to foster children. We also  interviewed officials from ACF, CMS, and SAMHSA, as well as child- welfare and Medicaid officials from selected states, to understand their  approach to providing oversight of psychotropic medications. We  assessed HHS’s efforts, including guidance provided to state Medicaid  and child-welfare programs regarding the monitoring of psychotropic  medications prescribed to children in foster care, using GAO’s Standards  for Internal Control in the Federal Government. We did not evaluate the  extent to which the five selected states’ procedures were being  implemented effectively.
We conducted this performance audit from January 2012 through April  2014 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our audit findings and conclusions based on our audit objectives. We  believe that the evidence obtained provides a reasonable basis for our  findings and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: Children enter state foster care when they have been removed from their  parents or guardians and placed under the responsibility of a state child- welfare agency. Removal from the home can occur because of reasons  such as abuse or neglect. When children are taken into foster care, the  state’s child-welfare agency becomes responsible for determining where  the child should live and providing the child with needed support. The  agency may place the foster child in the home of a relative, with unrelated  foster parents, or in a group home or residential treatment center,  depending on the child’s needs. The agency is also responsible for  arranging needed services, including mental-health services.  Coordinating mental-health care for children in foster care may be difficult  for both the medical provider and the caseworker depending on the  complexity of the child’s needs, and because multiple people are making  decisions on the child’s behalf. In addition, caseworkers in child-welfare  agencies may have large caseloads, making it difficult for them to ensure  each child under their authority receives adequate mental-health services.
In 2011, the Child and Family Services Improvement and Innovation Act  amended the Social Security Act to require states to identify protocols for  monitoring foster children’s use of psychotropic medications and to  address how emotional trauma associated with children’s maltreatment  and removal from their homes will be monitored and treated. ACF  requires states to address these issues in their required Annual Progress  and Services Reports (APSR) and has provided guidance detailing how  states are to address protocols for monitoring foster children’s use of  psychotropic medications as part of the state’s APSR. Among other  things, state monitoring protocols are to address  screening, assessment, and treatment planning to identify children’s  mental-health and trauma-treatment needs, including a psychiatric  evaluation, as necessary, to identify needs for psychotropic  medications; effective medication monitoring at both the client and agency level;  informed and shared decision making and methods for ongoing  communication between the prescriber, the child, caregivers, other  health care providers, the child-welfare worker, and other key  stakeholders.
According to ACF, child-welfare systems that choose to pursue  comprehensive and integrated approaches to screening, assessing, and  addressing children’s behavioral and mental-health needs—including the  effects of childhood traumatic experiences—are more likely to increase  children’s sense of safety and provide them with effective care. In  particular, ACF, CMS, and SAMHSA noted the role of evidence-based  practices—interventions shown to produce measureable improvements or  promising results—in decreasing emotional or behavioral symptoms. In  addition, according to ACF, psychotropic medication use with young  children, including infants, is of special concern since this population may  be especially vulnerable to adverse effects, necessitating careful  management and oversight.
As we reported in December 2011, oversight procedures such as  prescription monitoring help states to identify and review potentially risky  prescribing practices in the foster-care population. Monitoring for  appropriate dosage can be beneficial as it is important for any medication  or combination of medications prescribed to use appropriate dosages to  maximize the likelihood of effectiveness while also minimizing the chance  of potential adverse effects. Monitoring for concurrent use of multiple  psychotropic medications can be beneficial because, according to ACF,  there is little evidence of the effectiveness of using multiple psychotropic  medications at the same time and no research to support the use of five  or more psychotropic medications.
According to AACAP, treatment planning should include discussions by  key stakeholders, such as prescribers and caregivers, about the  assessment of target symptoms, behaviors, function, and potential  benefits and adverse effects of treatment options. As we reported in  December 2011, informed consent helps ensure that caregivers are fully  aware of the risks and benefits associated with the decision to medicate  with psychotropic medications and to accurately assess and monitor the  foster child’s reaction to the medications.
section_title: Case Studies Varied in Quality of Documentation Supporting the Use of Psychotropic Medications
paragraphs: Expert reviews of 24 foster children’s foster and medical files in five  selected states found that the quality of documentation supporting the  prescription of psychotropic medication usage varied with respect to (1)  screening, assessment, and treatment planning; (2) medication  monitoring; and (3) informed and shared decision making.
subsections: section_title: Quality of Documentation to Support Sufficient Screening, Assessment, and Treatment Planning Varied among Selected Cases
paragraphs: For each of our 24 cases, experts evaluated the foster and medical  records across six categories they developed collaboratively that relate to  screening, assessment, and treatment planning and provided their  professional opinion for the case. Examples of screening, assessment,  and treatment planning categories reviewed include the extent to which  medical examinations, psychiatric evaluations, and evidence-based  therapies were provided, and whether the impact of trauma was  addressed by treatment. As shown in table 1, experts found that the  quality of screening, assessment, and treatment planning varied among  selected cases according to documentation reviewed. To see how  experts scored all six categories, see appendix II.
Experts found that medical pediatric examinations were mostly supported  by documentation for 22 of 24 cases. Experts found in 2 of 24 cases the  medical pediatric examinations were partially supported, such as when  the medical pediatric exams were mentioned in the documentation, but  not actually included in the records, preventing experts from evaluating  what the examinations consisted of, and whether monitoring for  psychotropic agents, such as assessing height, weight, or laboratory  functions, was conducted. In one example, whereby experts scored the  medical pediatric exam category as mostly supported in documentation, a  child with a history of behavioral and emotional problems—including  aggression and hyperactivity—was prescribed multiple ADHD  medications. In this case, experts noted the child’s records had thorough  psychological and pediatric assessments, with comprehensive  discussions of diagnostic issues and medication rationale as well as good  case-management summaries.
subsections: section_title: Psychiatric Evaluations
paragraphs: Experts found that psychiatric evaluations were mostly documented for 12  of 17 applicable cases. Experts found 3 of 17 cases had partial  documentation to support that the child had received a full psychiatric  evaluation and 2 of 17 cases had no evidence that a psychiatric  evaluation took place. For example, in 1 case with mostly supporting  documentation, experts found that a child with a history of disruptive  behavior, poor impulse control, anger outbursts, and sexual acting-out  behaviors, among other things, received comprehensive psychosocial,  psychosexual, and neuropsychological evaluations. Moreover, experts  noted the child received special educational services and intensive  therapeutic services, and visited a psychiatrist monthly for several  months, then was referred back to the pediatrician with scheduled  psychiatric check-ins as appropriate.
section_title: Evidence-Based Therapies
paragraphs: Experts found that documentation reviewed supported that evidence- based therapies were mostly provided in 3 of 15 applicable cases where  the child may have benefited from such treatment. However, in 11 of 15  cases, the experts scored the category as partial, such as for instances  when some psychosocial or evidence-based therapies were documented  as provided, but other evidence-based therapies that may have been  more applicable or beneficial to the child were not provided, based on  documents reviewed. In 1 of 15 cases, there was no documentation that  evidence-based therapies were provided. In one case, experts found that  a child initially placed in foster care as a toddler with over 10 foster-care  placements—including group care from 14 to 16 years of age—had  experienced early neglect, exposure to domestic violence, and physical  abuse, and suffered from severe mood swings and explosive outbursts of  anger. According to experts, a larger focus on evidence-based treatments  such as trauma-focused cognitive behavioral therapy would have likely  benefitted the child, but there was no documentation showing this  occurred. However, according to the experts’ evaluation of the  documentation, the child’s psychiatric diagnoses and medication  regimens were stable over time, and treatment response, level of  treatment intensity, and level of psychosocial functioning were all  evaluated appropriately.
In another example, experts found that a child removed from the home at  age 13 after being physically assaulted by his mother and witnessing  domestic violence received supportive psychotherapy and counseling, but  there was no documentation of evidence-based psychotherapies, such as  trauma-focused cognitive behavioral therapy. In addition, the forms used  to document the therapy each represented 1 month of treatment with  progress notes from each of the four weekly sessions. However, the  report of the sessions, and often the entire content of the month’s  psychotherapeutic work, was duplicated for months at a time. One week’s  psychotherapy content was duplicated for over 1 year, raising questions  about what services were actually provided.
section_title: Impact of Trauma Addressed by Treatment
paragraphs: Experts found the documentation reviewed supported that the impact of  trauma was mostly addressed by treatment for 3 of 14 applicable cases.  However, for 8 of 14 cases, the impact of trauma was partially addressed  by the treatment provided to children who had suffered from traumatic  events, and in 3 cases there was no evidence that the trauma was  addressed, according to documentation reviewed. For example, experts  found in one case with no supporting documentation, that a child was  placed in foster care at 5 years of age for neglect and physical abuse and  diagnosed with a variety of different psychiatric conditions, including  bipolar disorder, post-traumatic stress disorder (PTSD), schizotypal  personality disorder, paranoia, and possible psychosis. According to  experts, psychosis and personality disorders are typically considered  adult conditions, and are usually not diagnosed in younger children. In  this case, the child was treated with variable combinations of ADHD  medications, antidepressants, anticonvulsants, and antipsychotics. While  hospitalized at age 9 years, the child received an ADHD and  antipsychotic medication at dosages that exceeded dosage guidelines  based on FDA-approved or medical literature maximum dosages for this  age group, and the medications were elevated to these high dosages  over a 1 week period. During this time, the child’s brother died, yet this  was not addressed or acknowledged during the psychiatric  hospitalization, according to documentation.
In another example, experts found that a child placed in foster care at 9  years of age due to neglect, physical abuse, and exposure to social  chaos and domestic violence received treatment that partially addressed  the impact of trauma on the child, according to documentation reviewed.  In this case the child reported additional trauma, saying his mother’s  boyfriend forced him to engage in sexual behavior with his sister. The  child’s grandmother, who had been his caretaker, also died when he was  13 years old. Experts noted the history of trauma was acknowledged, but  an evidence-based intervention was not provided to address the trauma,  according to documents reviewed.
section_title: Quality of Documentation Supporting Medication Monitoring Varied among Selected Cases
paragraphs: For each case, experts reviewed and provided their opinions across  seven categories related to medication monitoring, including the extent to  which prescriptions were appropriately monitored by medical providers,  appropriate dosages were used, and concurrent use of multiple  medications was justified based on documentation reviewed. As shown  in table 2, experts found that the quality of prescription monitoring by  medical providers, and justification for dosage and concurrent use of  multiple medications, varied among selected cases, based on  documentation reviewed. See appendix II for a full listing of all categories  experts reviewed related to medication monitoring.
Experts found in 13 of 24 cases that prescriptions were mostly monitored  by medical providers based on documentation reviewed. However, in 9 of  24 cases the prescriptions were partially monitored, and in 2 other cases  there was no evidence that prescriptions were monitored by medical  providers, according to documentation reviewed. For example, experts  found in one case with partially supporting documentation that the  monitoring of height, weight, vital signs, and metabolic effects of  antipsychotic medications was lacking and that the records did not  provide an adequate overview of medication risks and concerns regarding  concurrent use of multiple psychotropic medications. According to the  experts, these factors are important for medical providers to monitor in  order to better assess the potential adverse effects of the medication and  adjust as necessary to improve patient outcomes. In this case, the child  entered foster care at 3 years of age and was noted to be aggressive,  oppositional, not sleeping well, and hyperactive. Experts noted some of  the antipsychotic prescriptions (quetiapine and olanzapine) were given  “as needed” rather than scheduled, which, according to experts, is not  considered a good medical practice in a traditional foster-care setting.  Experts described the medication management as extremely aggressive,  with complicated regimens and dosages at or above the standard  recommendations. Furthermore, documentation that the medications  were effective was lacking.
subsections: section_title: Appropriate Dosages Used
paragraphs: For 13 of the 24 cases, experts found that the dosages were mostly  supported for the children’s medications based on documentation  reviewed. Although experts did not rate any cases as having no support  for the dosages for the entire medication regimen, in 11 of 24 cases the  experts noted that the justification to support a particular dosage level  was partially supported by the documentation. For example, experts  found in 1 case with partially supporting documentation, that a child  concurrently on seven different psychotropic medications received a  dosage for an ADHD medication (Adderall) exceeding dosage guidelines  based on FDA-approved or medical literature maximum dosages for  children and adolescents. Moreover, the documentation showed the  child received a very small dose of an antipsychotic medication  (quetiapine), suggesting that this agent was used for sleep, which experts  said is not considered a good medical practice. In this case, the child was  removed from the home at 14 months for, among other things, neglect  and physical abuse.
section_title: Justification for Concurrent Use of Multiple Medications
paragraphs: Experts found that for 5 of 20 applicable cases, concurrent use of multiple  psychotropic medications was mostly supported based on documentation.  However, 14 of 20 cases included documentation that partially supported  the concurrent use of multiple medications, and 1 case did not include  any documentation to support concurrent use. For example, experts  found in one case with partially supporting documentation that a toddler  diagnosed with ADHD/oppositional defiant disorder and bipolar disorder  was treated with complicated medication regimens, including mood  stabilizers and antipsychotics, when other nonmedication interventions  could have been considered, based on documentation reviewed. In this  case the child was prescribed an ADHD medication (methylphenidate)  and an antipsychotic medication (quetiapine) at 3-½ years of age. An  ADHD medication (clonidine) and mood-stabilizing medication  (oxcarbazepine) were tried by the time he was 4 years of age, and the  child was maintained on as many as four psychotropic medications  concurrently. As a 6-year-old, the child was treated with an antipsychotic  (paliperidone) that has not been studied in children this age. There was  limited discussion of potential risks or side effects though there were  several reported adverse effects, including insomnia, agitation, and a  possible movement disorder, potentially due to the use of antipsychotic  medications, according to documentation reviewed.
section_title: Quality of Documentation to Support Informed and Shared Decision Making Varied among Selected Cases
paragraphs: For each of our cases, experts evaluated the foster and medical records  for information related to informed and shared decision making— specifically, documentation of informed consent and communication  between treatment providers. As shown in table 3, experts found that  documentation to support informed consent and communication between  treatment providers varied among selected cases reviewed.
Experts found that informed-consent decisions were mostly documented  in 5 of 23 applicable cases. In 11 of 23 cases experts found partial  documentation of informed consent—such as when some, but not all,  medications prescribed to the child included documentation of informed  consent—and 7 other cases did not include any documentation of  informed consent. For example, in one case, experts reported there was  no documentation of informed consent, psychiatric evaluation, psychiatric  diagnosis, or monitoring of antipsychotic medication. In this case, the  child was prescribed an antianxiety medication (buspirone), an  antipsychotic medication (risperidone), and an ADHD medication  (clonidine) at 4 years of age, presumably to treat psychiatric symptoms  that interfered with his functioning, including short attention span,  wandering off, self-injury, and aggression. However, experts noted the  documentation was too sparse to determine why the psychotropic  medications were prescribed, and the indications, monitoring, and side  effects could not be evaluated.
subsections: section_title: Communication between Treatment Providers
paragraphs: Experts found that communication between treatment providers was  mostly documented in 15 of 23 applicable cases. However,  communication between treatment providers was partially documented in  5 of 23 cases, and there was no evidence that such communication  occurred in 3 of 23 cases. For example, experts found in one case with  partially supporting documentation that a teenage foster child with  cognitive delays and fetal alcohol effects/exposure was diagnosed with  ADHD and oppositional defiant disorder, and the quality of documentation  showing communication between treatment providers varied by the child’s  placement setting. When the child was placed in a residential treatment  facility, the communication between treatment providers was better  documented than when the child was placed in a foster home. However,  there was no clear documentation of communication between inpatient  and outpatient providers and there was no clear evidence in the foster  care files that the recommendations made by inpatient providers were  actually provided as part of outpatient care.
section_title: Some Prescriptions in Infant Cases Were for Non-Mental-Health Reasons, but others Were for Psychiatric or Unclear Reasons
paragraphs: Of the 24 cases reviewed, 9 were infant cases that the experts evaluated  to determine whether the prescriptions were for psychiatric or non-mental- health reasons. Experts found in 4 of 9 infant cases reviewed that the  prescription of psychotropic medication was for non-mental-health  purposes, based on documentation reviewed. However, experts found  that in 2 of 9 cases the infants were prescribed psychotropic medications  for psychiatric reasons, and the rationale and oversight for such  medications were partially supported by documentation. In 3 of 9 infant  cases, experts were unable to discern whether the psychotropic  medications were prescribed to infants for mental-health purposes or for  some other medical reason, based on documentation reviewed. These  results are summarized in table 4, below.
Experts found in two of nine infant cases that an antianxiety medication  (hydroxyzine) was prescribed to treat skin conditions such as a rash and  itchiness, and was not used for psychiatric purposes. In two other of nine  other infant cases reviewed, an ADHD medication (clonidine) was used to  treat sleep and irritability in children who had severe brain damage, and  who by the clinical descriptions were inconsolable. For each of the above  infant cases, experts agreed that there are no established standards for  treating problems associated with devastating neurological impairment in  infants. According to experts, although other medications, and possibly  nonmedication interventions, could have been used instead of clonidine,  the decision to treat was based on humanitarian reasons, and may have  been necessary to maintain the child in the foster home given the marked  distress displayed by the infants in these two cases. While physicians  may use their discretion to prescribe these psychotropic medications to  infants in these rare situations, non-mental-health uses still carry the  same risk of adverse effects, including, for the ADHD medication  clonidine, lowered blood pressure, changes in heart rate, and the  potential for sudden death, and should therefore be carefully monitored.
subsections: section_title: Psychotropic Medications Prescribed to Infants for Psychiatric Reasons
paragraphs: Experts found in two of nine infant cases reviewed that the psychotropic  medications were prescribed for psychiatric reasons, yet the justification  for such prescriptions was not clear based on documentation. For  example, experts found in one infant case that the child was prescribed  an antidepressant (amitriptyline) at 9 months of age, and a prescription  for an ADHD medication (clonidine) was added at 15 months of age to  target complications of his neurological condition, including self-injurious  behaviors, agitation, and aggression. Experts said there is no systematic  research supporting the use of amitriptyline for self-injurious behaviors in  any age group and the medication carries significant potential side  effects, including cardiac side effects, and has been associated with  sudden death in young children. Additionally, according to experts,  amitriptyline can cause or exacerbate corneal ulceration, a painful  condition for which this toddler was being treated, and which reportedly  exacerbated the child’s agitation. The case notes focus on medical issues  with limited discussion of rationale, efficacy, or tolerability of psychotropic  medications. In another infant case, experts found that clonidine was  prescribed for sleep and behavioral issues, but the records did not show  that the associated risks of the medications were discussed, and informed  consent was not documented. According to experts, the medical records  in this particular case also included a note from the prescribing doctor  when the child was 20 months of age stating that clonidine was not a  psychotropic medication while also stating that the medication was for  behavioral problems.
section_title: Psychotropic Medications Prescribed to Infants for Unclear Reasons
paragraphs: Experts found in three of nine infant cases reviewed that documentation  was unclear as to whether the psychotropic medications were prescribed  for mental or non-mental-health purposes. For the first infant case with  unclear documentation, experts noted that the child received a 2-month  trial of an ADHD medication (clonidine) at 16 months of age, which  experts stated they presumed was prescribed for irritability or difficulty  sleeping, based on available documentation, but the actual indications  were not documented. In the second infant case with unclear  documentation, experts’ review showed the child received a number of  different anticonvulsants to try to improve seizure control. However, the  infant was also prescribed a 2-month trial of an antianxiety medication  (clonazepam) as a 1-year-old, and, according to the experts, the records  did not indicate whether the medication was prescribed to treat the  seizures or for psychiatric purposes. In the third infant case with unclear  documentation, experts reported the child was prescribed an antianxiety  medication (hydroxyzine), presumably to treat a skin irritation; however,  there were no notes describing the rationale for the medication.
The experts agreed that prescriptions of psychotropic medications to  infants carries significant risk as there are no established mental-health  indications for the use of psychotropic medications in infants and the  medications have the potential to result in serious adverse effects for this  age group.
section_title: Selected States Have Policies and Procedures Intended to Address Oversight of Psychotropic Medications to Foster Children, and HHS Issued Guidance for Monitoring Psychotropic Medications
paragraphs: Selected states have policies and procedures that are intended to provide  oversight of psychotropic medications given to foster children. In addition,  HHS has issued guidance, provided technical assistance, and facilitated  information-sharing efforts among state child-welfare and Medicaid  officials related to oversight of psychotropic medications for children in  foster care. However, additional HHS guidance could help state child- welfare and Medicaid officials manage psychotropic medications as  states transition prescription drug benefits to managed care.
subsections: section_title: Selected States’ Policies and Procedures Address Oversight of Psychotropic Medications to Foster Children
paragraphs: To varying degrees, each of the five selected states we reviewed has  policies and procedures designed to address the monitoring and  oversight of psychotropic medications prescribed to children in foster  care. Some variation is expected because states set their own oversight  guidelines. However, the 2011 Child and Family Services Improvement  and Innovation Act required states to establish protocols for the  appropriate use and monitoring of psychotropic medications prescribed to  children in foster care, which ACF described in a 2012 program  instruction. According to ACF, the unique factors of each state, such as  whether the child-welfare service-delivery structure is state- or county- administered, the type of Medicaid delivery system in place, and the  availability of qualified practitioners, may influence how officials develop  oversight protocols. Thus, according to ACF, each state needs to  carefully assess existing oversight mechanisms and evaluate options in  light of how they fit with the state’s own set of needs and challenges. As  part of ACF’s 2012 program instructions, states are to address protocols  for monitoring foster children’s use of psychotropic medications as part of  the state’s APSR, which include protocols to address: (1) screening,  assessment, and treatment planning mechanisms; (2) effective  medication monitoring at both the client and the agency-wide level; and  (3) shared decision making and communication among the prescriber, the  child, caregivers, other health care providers, and the child-welfare  worker. Below are examples of selected states’ policies and  procedures—based on documents we reviewed and interviews with state  Medicaid and child-welfare officials—that are intended to provide  oversight of psychotropic medications to children in foster care. The  information is presented using the same categories discussed above for  experts’ review of case studies. We did not assess the extent that these  activities are being implemented effectively in the states.
subsections: section_title: Medical Pediatric Examinations
paragraphs: Each of our five selected states require that children in foster care receive  medical examinations. For example, officials reported that in Oregon a  child must receive a medical examination within 30 days and a mental- health exam within 60 days after the child enters the foster-care system,  whereas Michigan officials said that both the medical and mental-health  exams are to occur within 30 days.
section_title: Psychiatric Evaluations
paragraphs: All five selected states’ foster-care programs use some type of functional  assessment or screening tool, such as the Child and Adolescent Needs  and Strengths (CANS), for screening and treatment planning, which may  prompt a referral for a psychiatric evaluation as deemed appropriate.  However, according to foster-care officials from Massachusetts, the  CANS assessment tool is not sufficient to screen for a child’s exposure to  trauma and there is a need for a separate trauma-screening mechanism.  Medicaid and foster-care officials from Texas told us in July 2013 that  they are working to research and develop a comprehensive psychosocial- assessment process with trauma screening/assessment components that  is tailored to the unique needs of children in foster care. In April 2014,  officials estimated that the process will take at least another year to  implement and may be phased in so they could evaluate the  effectiveness and refine the process.
section_title: Evidence-Based Therapies Provided
paragraphs: Each of our five selected states has taken action to increase children’s  access to evidence-based therapies. For example, Oregon mental-health  officials said that state law requires that 75 percent of the funding for  mental-health agencies is to be used for evidence-based practices, and  that the state surveys its mental health providers every 2 years on their  utilization of evidence-based practices and reports these results to the  state legislature. Oregon mental-health officials also said site reviews of  mental-health providers occur every 3 years to make sure the providers  are using practices on the state’s approved list of evidence-based  practices and if deficiencies are identified, correction plans are  developed. As another example, Massachusetts’s foster-care agency— through a federally funded grant—has provided evidence-based training  on trauma-focused cognitive behavioral therapy, child-parent  psychotherapy, and attachment self-regulation to both general  practitioners and child-welfare staff to raise awareness and improve  methods for treating and overseeing the child’s overall health.
section_title: Impact of Trauma Addressed by Treatment
paragraphs: Each of our five selected states has taken action to improve focus on  trauma-related needs of children in foster care. For example, Oregon was  awarded a 3-year technical assistance grant by the Center for Health  Care Strategies in April 2012. According to Oregon officials, one of the  goals of this grant is to better understand the impact of trauma on  emotions, behavior, and relationships, and to support training and policy  development in this area. Beginning in May 2012, Texas implemented a  5-year strategic plan regarding trauma-informed care across the state for  foster-care children. To do this, the state Medicaid program, foster-care  agency, and managed-care organization (MCO) under contract are all  working together to build a trauma-informed care system by incorporating  trauma screening/assessment into psychosocial-assessment processes,  enhancing clinical capacity to provide trauma-focused, evidence-based  psychosocial therapy, training key stakeholders, and incorporating the  principles of trauma-informed care into child-welfare policy and practices,  according to Texas officials.
section_title: Prescriptions Appropriately Monitored
paragraphs: All five of the selected states have designed a mechanism to coordinate  and share some or all Medicaid prescription claims data with the state’s  foster-care agency to help monitor and review cases based on varying  criteria, such as prescriptions for children under a particular age, high  dosages, or concurrent use of multiple medications. For example,  according to Florida Medicaid officials, beginning in 2011 the state began  requiring documentation of safety monitoring, such as metabolic  monitoring, and body-mass-index information, to be included as part of  the prior-authorization review process before particular medication  regimens are approved for reimbursement. However, these reviews are  limited to those prescription claims paid for on a fee-for-service basis.  Beginning in October 2014, foster children in Florida are to receive all of  their Medicaid benefits through a third-party MCO, and it was unclear to  state Medicaid officials how MCOs will provide oversight of psychotropic  medications after the transition from fee-for-service to managed care  occurs. Massachusetts uses both a fee-for-service model and MCOs to  administer prescription claims benefits. Massachusetts child-welfare  officials said that in the fee-for-service program, certain parameters, such  as children in foster care prescribed four or more psychotropic  medications, or two or more psychotropic medications of the same class,  or children less than 6 years old prescribed a psychotropic medication,  are flagged and forwarded to a child psychiatrist for additional review.  However, among children served by MCOs, state Medicaid officials said  that MCOs flag cases for children prescribed psychotropic drugs who are  less than 6 years old, but state Medicaid officials were uncertain how  MCOs followed up on these cases. In Texas there is a single MCO used  to coordinate all prescription claims and medical services for children in  foster care, and this organization works closely with the state foster-care  agency to identify and monitor psychotropic medication use among  children in foster care.
section_title: Appropriate Dosages Used
paragraphs: All five of the selected states have designed measures to review certain  prescriptions that have dosages above a particular threshold. For  example, in February 2005, Texas developed psychotropic drug- utilization parameters that outline what prescribing scenarios require an  additional review, and these parameters were updated in January 2007,  December 2010, and September 2013. Prescriptions that exceed usual  recommended dosages for the child’s age trigger an additional review  from a child psychiatrist. Similarly, in 2012, Michigan’s Medicaid and  foster-care agencies began identifying and reviewing foster children’s  prescriptions if the medication exceeds the recommended dosages.  According to officials, Florida, Massachusetts, and Texas Medicaid  programs also require prior authorizations before a prescription is  approved for reimbursement for various prescribing scenarios specific to  psychotropic medications. As stated in the section above concerning  prescription monitoring, state Medicaid officials from Massachusetts and  Florida told us they are still in the process of determining to what extent  monitoring and oversight protocols—including prior authorizations— function for children in foster care who are prescribed medications  through MCOs.
section_title: Justification for Concurrent Use of Multiple Medications
paragraphs: All five of the selected states have designed measures to review  prescriptions for concurrent use of multiple medications to a varying  extent. For example, the MCO that handles prescription claims for  children in foster care in Texas monitors and completes additional  reviews for concurrent prescriptions, and shares that information with the  state foster-care and Medicaid agencies for the following medication  regimens as stated in the September 2013 Texas Utilization parameters:  four or more concurrent psychotropic medications;  two or more concurrent antidepressants;  two or more concurrent antipsychotic medications;  two or more concurrent stimulant medications; and  three or more concurrent mood-stabilizer medications.
Similarly, since 2012, the Michigan Medicaid agency monitors concurrent  use of multiple medications using criteria, including four or more  concurrent psychotropic medications, or two or more concurrent  psychotropic medications within the same class, and shares this  information with the state foster-care agency to facilitate additional  reviews. Each of the above prescribing scenarios triggers an additional  review that may include discussions with the prescriber to review the  details and justification in support of the prescriptions. As mentioned  previously in this report, Florida, Massachusetts, and Texas Medicaid  programs also require prior authorizations before a prescription is  approved for reimbursement for various prescribing scenarios specific to  psychotropic medications. However, as stated above concerning  prescription monitoring, state Medicaid officials from Massachusetts and  Florida told us they are in the process of determining to what extent  monitoring and oversight protocols—including prior authorizations— function for children in foster care prescribed medications through MCOs.
section_title: Informed Consent
paragraphs: Each of the five selected states require informed consent for psychotropic  medications, but state practices vary. For example, according to agency  officials, individuals authorized to give informed consent for a foster child  vary across states. In Oregon, foster parents are not authorized to give  informed consent for children in state custody—the foster child’s case  supervisor provides informed consent for psychotropic medications. As  another example, officials from Texas told us that according to state law,  when the court places a child in the custody of the state foster-care  program, the court must authorize an individual or the child-welfare  agency to consent to medical care for a child in foster care. When the  court authorizes the child-welfare agency, the agency must designate a  medical consenter—which typically includes emergency-shelter  employees or live-in caregivers if the child is placed in community  settings, or child-welfare staff when children are placed in facilities such  as residential treatment centers.
section_title: Communication between Treatment Providers
paragraphs: Four of five selected states have some limitations regarding the extent to  which a child’s medical history is available to treatment providers. For  example, in Oregon, medical providers have access to a child’s  prescription claims and medical history so long as the child was treated  by a medical provider within the same Coordinated Care Organization  (i.e., MCO), though the accessibility of information varies by each  Coordinated Care Organization and is largely unavailable from competing  Coordinated Care Organizations within the state. As another example,  state Medicaid and foster-care officials from Michigan said they were in  the process of developing electronic health records to improve access to  information for prescribers, but noted that privacy concerns and legal  limitations make it very difficult to share medical information across  various medical providers. Texas is unique in that the state uses a single  MCO to coordinate all prescription claims for children in foster care, which  gives all participating medical providers access to prescription claims and  the child’s medical history electronically.
section_title: Psychotropic Prescriptions to Infants
paragraphs: Each of the five selected states, to varying extent, have designed  measures to review prescriptions of psychotropic medications based on  the child’s age, which includes prescriptions to infants. For example,  Oregon officials said that state law requires an annual review of  medications by a licensed medical professional or qualified mental-health  professional with authority to prescribe medications, other than the  prescriber, if the child is covered by Medicaid and under the age of 6  years. Similarly, since 2012, Michigan’s foster-care agency reviews  medical records of all children in foster care less than 1 year old who are  prescribed psychotropic medication to determine whether the prescription  was for psychiatric purposes or non-mental-health reasons. As mentioned  previously in this report, Florida, Massachusetts, and Texas Medicaid  programs also require prior authorizations before a prescription is  approved for reimbursement for various prescribing scenarios specific to  psychotropic medications. Officials from Massachusetts and Florida told  us they are in the process of determining how monitoring and oversight  currently function for children in foster care who are prescribed  medications through MCOs.
section_title: HHS Has Issued Guidance, Provided Technical Assistance, and Facilitated Information Sharing
paragraphs: In response to concerns and our December 2011 report recommendation  related to the need for additional guidance for the prescribing of  psychotropic medications for children in foster care, HHS’s ACF has  taken actions to improve the capacity of states’ child-welfare agencies to  effectively respond to the complex needs of children in foster care. As  previously mentioned in this report, ACF issued a program instruction in  April 2012 to help states implement the new requirements in the Child  and Family Services Improvement and Innovation Act regarding the  development of protocols for oversight of psychotropic medication. In  addition, since our December 2011 report, ACF has worked  collaboratively with CMS and SAMHSA to help states strengthen  oversight of psychotropic medications to children in foster care by  emphasizing the need for collaboration between state Medicaid, child- welfare, and mental-health officials in providing oversight; providing  technical assistance; and facilitating information sharing. Several  initiatives were performed, including the following:
CMS and SAMHSA participated in an ACF-led 2012 webinar series to  help provide states with technical assistance in developing oversight  and monitoring plans for psychotropic medications, as required by the  Child and Family Services Improvement and Innovation Act. Using a  question-and-answer format, the webinars featured experts, including  researchers, child psychiatrists, and ACF staff, who provided ideas  and feedback to state officials on planning efforts.
In August 2012, ACF, CMS, and SAMHSA cohosted a conference for  state child-welfare, Medicaid, and mental-health officials on  strengthening the management of psychotropic medications for  children in foster care. Conference sessions focused on effective  collaborative medication monitoring, as well as creating data systems  to facilitate collaboration, among other things. According to ACF,  CMS, and SAMHSA officials, the conference was an opportunity for  states to talk and share practices. According to ACF officials,  representatives from 49 states attended, including officials from 4 of  the 5 states covered by our review. Officials from one of these states  said the conference was beneficial. Officials from another state said  participation challenged them to augment their system; officials from  another state said it was helpful to hear what other states were doing;  and officials from a fourth state said that it was important for the three  federal agencies to have common goals, which would help sustain  interagency collaboration at the state level.
In addition, CMS officials said the issue of psychotropic medications was  a catalyst that caused the HHS agencies to look at broader issues related  to mental health, including trauma-informed care and the use of mental- health screening tools and evidence-based therapies. ACF, CMS, and  SAMHSA have undertaken several efforts, including the following:  In 2012 and 2013, ACF announced funding opportunities for projects  supporting the comprehensive use of evidence-based screening and  assessment of mental and behavioral health needs, among other  things.
In March 2013, CMS issued guidance informing states about  resources available to help meet the needs of children under the Early  and Periodic Screening, Diagnostic, and Treatment (EPSDT)  Medicaid benefit. Under the EPSDT, eligible individuals, such as  children in foster care, are to be provided periodic screenings that  include assessments of physical and mental-health development, as  well as any medically necessary screenings to detect suspected  illnesses or conditions not discovered during periodic exams. Results  from screenings may trigger the need for further assessment to  diagnose or treat a mental-health condition.
In July 2013, ACF, CMS, and SAMHSA officials cosigned a letter to  state child-welfare, Medicaid, and mental-health officials encouraging  the integrated use of trauma-focused screening, functional  assessments, and evidence-based practices to improve child well- being. In particular, federal officials noted that a high percentage of  children in state foster care have been exposed to traumatic events  and that there is reason to believe that problematic use of  psychotropic medications is a reaction to the complexity of symptoms  among children exposed to trauma and the lack of appropriate  screening, assessment, and treatment.
Figure 1 below lists initiatives undertaken since our previous report by  ACF, CMS, and SAHMSA.
In addition, according to ACF officials, in collaboration with SAMHSA and  others, ACF plans to issue guidance in August 2014 to foster parents  regarding psychotropic medication to enhance their understanding of  these medications.
section_title: Additional Guidance Could Help Officials Manage Psychotropic Medications as States Transition Prescription-Drug Benefits to Managed Care
paragraphs: Three of five states included in our review use, or are transitioning from  fee-for-service to, MCOs to administer prescription-drug benefits for  mental-health medications; however, Medicaid officials from two of those  three states reported that their states had conducted limited planning to  ensure appropriate oversight of MCOs administering psychotropic  medications—which creates a risk that state controls instituted in recent  years under fee-for-service may not apply to managed care—and could  benefit from additional federal guidance.
In Massachusetts, most foster children receive drug benefits through  fee-for-service, according to state Medicaid officials, though some  children receive these benefits through MCOs. Under fee-for- service, beginning in 2012, state Medicaid prescription claims data  were to be provided to the state child-welfare agency to monitor and  facilitate additional reviews, as necessary, for children prescribed  medications in foster care. For example, according to child-welfare  officials, cases that meet certain criteria—children less than 6 years  old prescribed a psychotropic medication; children prescribed four or  more psychotropic medications; or children prescribed two or more  psychotropic medications in the same class—are flagged and  forwarded to a child psychiatrist for further review. According to  Massachusetts Medicaid officials, MCOs currently review cases when  a child less than 6 years old is prescribed a psychotropic medication.  State Medicaid officials said they did not know how MCOs followed up  on cases last year. However, state Medicaid officials and other  members of an interagency committee on psychotropic medications  have met with MCO administrators to learn what they are doing to  review cases and will continue to monitor MCOs, according to  Massachusetts state officials. Such operational information is  important for the child-welfare agency to obtain to help ensure that  appropriate oversight of psychotropic medication prescribed to foster  children occurs. In addition, as part of the state’s efforts to improve  the prescribing, authorization, and monitoring of psychotropic  medications, a Massachusetts interagency committee on psychotropic  medications and foster children noted that MCOs’ and the state’s  primary-care clinician plan program’s role in the prior-authorization  process has not been determined, in particular whether these  organizations will have to assume responsibility for assuring that  psychiatrists in their network adhere to the state’s prescribing and  monitoring practices.
Florida Medicaid officials said that beginning in 2014, MCOs will  provide Medicaid participants, including foster children, with mental- health services, but it was unclear to state Medicaid officials how  MCOs will provide oversight of psychotropic medications after the  transition from fee-for-service to managed care occurs. Such  operational information is also important for Florida’s child-welfare  agency to help ensure that appropriate oversight of psychotropic  medication prescribed to foster children occurs. Florida Medicaid  officials said that there will probably no longer be point-of-sale  controls, which were instituted under fee-for-service in 2011. These  controls, for example, required prescribers to submit forms indicating  that safety monitoring, such as monitoring for signs of abnormal  involuntary movement and metabolic monitoring, was performed for  certain medications. If such point-of-sale controls are not continued  under MCOs, then safety monitoring developed by the state under  fee-for-service may not continue for children administered  medications through MCOs.
ACF officials we met with noted that state child-welfare have experienced  challenges coordinating with state Medicaid programs regarding the  transition to MCOs, particularly with regard to data sharing. There are  indications that the number of states using MCOs to administer drug  benefits may increase. In 2012, the HHS Office of Inspector General  (OIG) reported that 16 states used MCOs to administer drug benefits, and  another 5 states had, or were planning, to switch to MCOs as a result of  the Patient Protection and Affordable Care Act expansion of the Medicaid  drug-rebate program, which allows states to obtain rebates from  manufacturers for covered outpatient drugs. Previously, medications  dispensed by MCOs were excluded from such rebates.
According to Standards for Internal Control in the Federal Government,  internal controls should generally be designed to assure that ongoing  monitoring occurs in the course of normal operations, and is performed  continually and ingrained in the agency’s operations. ACF requires  states to develop effective medication monitoring at the agency and  patient level. To this end, ACF, CMS, and SAMHSA have developed  guidance for state Medicaid, child-welfare, and mental-health officials  related to the oversight of psychotropic medications underscoring the  need for collaboration between state officials to improve prescription  monitoring. However, this guidance does not address oversight within the  context of a managed-care environment, in which states rely on a third  party to administer benefits such as psychotropic medications.  Additional guidance from HHS that helps states prepare and implement  monitoring efforts within the context of a managed-care environment  could help ensure appropriate oversight of psychotropic medications to  children in foster care.
section_title: Conclusion
paragraphs: Since our December 2011 report, HHS has issued guidance regarding  the oversight of psychotropic medications among children in foster care  and has undertaken collaborative efforts to provide guidance and promote  information sharing among states. In addition, HHS efforts have focused  on using mental-health screening tools and providing therapies that  address trauma, which seek to ensure that the mental-health needs of  children in foster care are appropriately met. However, many states have,  or are transitioning to, MCOs to administer prescription-drug benefits,  and, as our work demonstrates, selected states have taken only limited  steps to plan for the oversight of drug prescribing for foster children  receiving health care through MCOs—which creates a risk that controls  instituted in recent years under fee-for-service may not remain once  states move to managed care. Additional guidance from HHS that helps  states prepare and implement monitoring efforts within the context of a  managed-care environment could help ensure appropriate oversight of  psychotropic medications to children in foster care.
section_title: Recommendation for Executive Action
paragraphs: To assist states that rely on or are planning to contract with an MCO to  administer Medicaid prescription benefits, and to help provide effective  oversight of psychotropic medications prescribed to children in foster  care, we recommend that the Secretary of Health and Human Services  issue guidance to state Medicaid, child-welfare, and mental-health  officials regarding prescription-drug monitoring and oversight for children  in foster care receiving psychotropic medications through MCOs.
section_title: Agency and Third- Party Comments and Our Evaluation
paragraphs: We provided a draft copy of this report to HHS and the state foster-care  and Medicaid agencies of the five selected states for their review. HHS,  the Florida Agency for Health Care Administration, and the  Massachusetts Executive Office of Health and Human Services provided  written comments that are summarized below and reprinted in full in  appendixes III, IV, and V, respectively. HHS, Massachusetts, Oregon,  and Texas provided technical comments, which we incorporated as  appropriate. Michigan did not have any comments on the report.
In its response, HHS concurred with our recommendation to issue  guidance to state Medicaid, child-welfare, and mental-health officials  regarding prescription-drug monitoring and oversight for children in foster  care receiving psychotropic medications through MCOs, and stated that  CMS will work with other involved agencies to coordinate guidance  between CMS and other HHS agencies. HHS further stated that guidance  can be targeted regarding the use of MCOs for the foster-care population,  but noted that previously issued guidance to state agencies from HHS  already applies. However, the guidance that HHS referred to in its written  comments is not specific to oversight within the context of a managed- care environment, and officials from the states in our review agreed that  additional federal guidance could be beneficial. Therefore, we continue to  believe that specific guidance to help states prepare and implement  monitoring efforts within the context of a managed-care environment is  needed to help ensure appropriate oversight of psychotropic medications  to children in foster care.
In its written comments, the Florida Agency for Health Care  Administration did not indicate whether it agreed or disagreed with our  findings and recommendation, but said that it appreciated our efforts to  evaluate Florida’s Medicaid program and the reimbursement of  psychotropic medications for foster children. Florida’s response also  provided additional information about the state’s future plans for using  managed-care plans and drug-utilization review requirements. For  example, Florida’s response stated that these managed-care plans must  adhere to Florida statute requirements regarding prior-authorization  procedures for covering medically necessary services, including  prescription-drug services. However, the extent to which drug-utilization  reviews and point-of-sale controls currently used by the state under fee- for-service would apply after transitioning to MCOs is still unclear. For  example, as we discussed in the report, if point-of-sale controls are not  continued under MCOs, then safety monitoring developed by the state  under fee-for-service may not continue for children administered  medications through MCOs.
In its written comments, Massachusetts’s Executive Office of Health and  Human Services did not indicate whether it agreed or disagreed with our  findings and recommendation, but thanked us for recognizing the work  Massachusetts has done in the area of psychotropic medications being  administered to children in foster care and agreed that discussion and  investigation of this topic is timely and important to improve the health  and welfare of children in foster care. In its response, Massachusetts  noted that MCO contracts require the MCOs to monitor psychotropic  prescribing for members under the age of 19 in accordance with  guidelines established by Massachusetts’s Psychoactive Medications in  Children Working Group. Massachusetts also stated it conducted an  operational review with each MCO to ensure that there is an established  follow-up process for cases that are flagged, and that it continues to  monitor MCOs closely to assure they remain in compliance with this  contract requirement. However, the extent to which Massachusetts has  developed guidelines, conducted operational reviews, and monitored for  MCO compliance is still unclear.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies of this report to the  Secretary of Health and Human Services, relevant state agencies, and  interested congressional committees. In addition, the report will be  available at no charge on the GAO website at http://www.gao.gov.
If you have any questions concerning this report, please contact me at  (202) 512-6722 or lords@gao.gov. Contact points for our Offices of  Congressional Relations and Public Affairs may be found on the last page  of this report. Key contributors to this report are listed in appendix VI.
section_title: Appendix I: Expert Selection and Biographies
paragraphs: To provide a clinical perspective on our cases, we contracted with two  child psychiatrists who have clinical and research expertise in the use of  psychotropic medications in children. We reviewed the curriculum vita for  each expert who responded to our contract solicitation to determine  whether the expert met all of the following criteria:  is a medical doctor;  is trained in child psychiatry;  is board certified in child psychiatry;  conducted relevant research or had relevant experience; and  is a member of a relevant association (e.g., American Academy of  Child and Adolescent Psychiatry).
We also conferred with officials from the National Institute of Mental  Health.
We selected Jon McClellan, MD, and Michael Naylor, MD. Dr. McClellan  is an attending psychiatrist at Seattle Children’s Hospital; a professor at  the University of Washington School of Medicine; and the medical director  at Washington’s Child Study and Treatment Center, the children’s  psychiatric hospital for the state of Washington. He is board certified in  psychiatry and child and adolescent psychiatry, has conducted research  regarding mental illness in children, and contributed to a forum on  psychotropic medication use amongst children in foster care. Dr. Naylor is  an associate professor at the University of Illinois at Chicago, School of  Medicine, and the director of the Behavioral Health and Welfare Program,  which was formed to address the mental-health needs of the most  severely disturbed children in state care. He directs the Clinical Services  in Psychopharmacology program, which provides an independent review  of all psychotropic medication consent requests for foster children in  Illinois. He is board certified in child and adolescent psychiatry, general  psychiatry, and sleep-disorders medicine.
section_title: Appendix II: Case-Rating Summary Table
paragraphs: The figure below contains the ratings assigned by experts for the quality  and quantity of certain types of documentation contained in each child’s  foster and medical files. Cases are organized by the criteria used to  randomly and nonrandomly select them and include reviews of cases  from each of our selected states—Florida, Massachusetts, Michigan,  Oregon, and Texas.
section_title: Appendix III: Comments from the Department of Health and Human Services
section_title: Appendix IV: Comments from the Florida Agency for Health Care Administration
section_title: Appendix V: Comments from the Massachusetts Executive Office of Health and Human Services
section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Matt Valenta, Assistant Director;  Adam Anguiano; Erika Axelson; Scott Clayton; Marcus Corbin; Jennifer  Costello; Dennis Fauber; Wilfred Holloway; Olivia Lopez; Flavio Martinez;  Maria McMullen; Linda Miller; Sandra Moore; James Murphy; Joy Myers;  Anna Maria Ortiz; April Van Cleef; Abby Volk; and Monique Williams  made significant contributions to this work.