Children with mental health conditions can be treated with psychotropic medications, psychosocial therapies, or a combination of both. Psychotropic medications can be very effective in treating children with mental health conditions, but they may also produce side effects, some of which can be serious. For example, according to the American Academy of Child & Adolescent Psychiatry (AACAP), medications used to treat ADHD can reduce symptoms such as hyperactivity in children, as well as improve their attention and increase their ability to get along with others. These medications have been widely tested in children and are generally considered safe; however, ADHD medications have also been associated with side effects ranging from mild to serious, such as sleeplessness, loss of appetite, tics, agitation, hallucinations, liver problems, and suicidal thoughts. Research has shown that foster children take psychotropic medications at much higher rates than other children covered by Medicaid. For example, we previously reported that while about 5 to 10 percent of nonfoster children in five states’ Medicaid programs took a psychotropic medication in 2008, rates among children in foster care were about 20 to 39 percent. The use of five or more medications concomitantly (that is, at the same time), while rare, was also higher among children in foster care. We reported that several factors may have contributed to the higher utilization rates among foster children, such as the increased prevalence and greater severity of mental health conditions among these children. Studies have shown that rates of psychotropic medication use among all children have increased. For example, one study found that the percentage of children’s doctor visits involving psychotropic medications increased by 75 percent from 1996 to 2007—from 6 percent to about 11 percent. Among these visits, those involving two or more medications rose from about 14 percent to about 20 percent. Experts have identified a number of potential factors that could account for the increased use of psychotropic medications. For example, AACAP’s guidelines on the use of psychotropic medications for children identified explanations such as the expanding evidence base demonstrating the efficacy of these medications for children and the efforts of pharmaceutical companies to market drugs to prescribers and consumers. Pharmacy benefit managers are firms that administer prescription drug benefits on behalf of health insurance plans. Furthermore, some studies found that the prescribing of antipsychotics was higher among publicly insured children than among privately insured children, and even higher among foster children. One study found that children enrolled in Medicaid were prescribed antipsychotic medications at over four times the rate of children with private insurance in 2004. In addition, AHRQ funded a study of antipsychotic prescribing based on Medicaid claims from 13 states, which found that utilization of antipsychotics in 2007 was much higher among foster children than among nonfoster children in Medicaid—12.4 percent on average versus 1.4 percent, respectively. Prescribing of antipsychotics is a concern for CMS and state Medicaid programs not only because of safety issues, but also because these medications are costly. They represented the single largest drug expenditure category for Medicaid in 2007—over $2.8 billion. One reason for particular concern about growing use of antipsychotics and other psychotropic medications in children is that manufacturers do not always test medications for use in children. Manufacturers are responsible for conducting clinical trials and demonstrating their products’ safety and efficacy to FDA, which is responsible for making decisions about whether and how medications can be marketed for children and for ensuring that manufacturers incorporate information from pediatric clinical trials into medication labels when required. However, because children are a small part of the overall population and physicians can prescribe medications off-label to children even if the medications have been tested only in adults, manufacturers may lack economic incentives to conduct trials with children. According to a recent analysis by FDA scientists, fewer than half of all medications were adequately labeled for pediatric use in 2009. The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) address testing of medications in children by authorizing FDA to provide incentives for or require manufacturers to conduct pediatric studies in certain circumstances. (For more information on BPCA and PREA and label changes for psychotropic medications resulting from these laws, see app. III.) Psychosocial therapies are mental health treatments that generally involve sessions with a mental health professional that are designed to reduce patients’ emotional or behavioral symptoms. Such therapies may be used instead of, or in combination with, psychotropic medications to Psychosocial therapies that treat children with mental health conditions.have been shown to be effective in treating mental health conditions may be referred to as evidence-based therapies (EBT). While there is no standard definition of what constitutes “evidence-based,” some federal agencies and provider organizations evaluate and compile information on available therapies. For example, SAMHSA maintains the National Registry of Evidence-based Programs and Practices, a list of treatments that have been assessed by independent evaluators and rated on the strength of the evidence showing their effectiveness. Provider organizations may also make recommendations to providers on which treatments to use. For example, AACAP publishes practice parameters that contain recommendations for treating specific disorders, with each recommendation labeled to indicate the strength of the evidence underlying it. Although psychosocial therapies may be effective for many children, the Institute of Medicine and others have reported that a shortage of mental health providers in general is a major factor affecting access to services, especially for children. Furthermore, finding a mental health professional who has been trained to provide a specific EBT can be a challenge because training in EBTs is not uniformly required in medical and professional schools. Children enter foster care when they have been removed from their parents or guardians and placed under the responsibility of a state child welfare agency, often because of maltreatment at home. Removal from the home can occur for multiple reasons, including parental violence, substance abuse, severe depression, or incarceration. According to ACF, 46 percent of children investigated by child welfare services came to a state’s attention primarily because of a report of neglect, and 27 percent had experienced physical abuse as the most serious form of recorded maltreatment. Other children are referred when their own behaviors or conditions are beyond the control of their families or they pose a threat to themselves or the community. Children in foster care can experience traumatic stress due to maltreatment experienced at home as well as the trauma of being removed from their homes. Trauma significantly increases the risk of mental health problems, difficulties with social relationships and behavior, physical illness, and poor school performance. Furthermore, child mental health experts have stated that the traumatic stress symptoms foster children may experience are often the same as symptoms that can indicate other mental health conditions, which may lead to misdiagnosis and inappropriate treatments. 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 supports. 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 responsible for arranging needed services, including mental health services. Federal officials, providers, and child and mental health advocacy groups have identified several factors that create challenges for foster children in receiving appropriate mental health services. Foster children can experience frequent changes in their living placements, which can lead to a lack of continuity in mental health care, and new providers may not have the medical history of the patient.This lack of stability can lead to treatment disruptions and can increase the number of medications prescribed. Coordinating mental health care for foster children may be difficult for both the medical provider and the case worker 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 that foster children’s mental health needs are being met. As a condition of receiving federal child welfare grant funding, state child welfare agencies must annually submit plans to ACF that, among other things, address the mental and other health needs of foster children. In 2011, the Child and Family Services Improvement and Innovation Act (Child Improvement Act) required states, as part of these plans, 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 home will be monitored and treated. As part of their June 2012 Annual Progress and Service Reports to ACF, states provided information on their plans for monitoring psychotropic medication prescribing and treatment of emotional trauma for foster children. Prior to the Child Improvement Act, many states had already implemented policies and practices regarding prescribing psychotropic medications for foster children, such as issuing written guidelines for prescribers, collecting data to monitor prescribing, requiring informed consent from relevant parties before filling a prescription, and requiring consultation with a mental health specialist for prescriptions exceeding certain dosage thresholds. On average, 6.2 percent of noninstitutionalized children in Medicaid nationwide took psychotropic medications during a calendar year from 2007 through 2009, and 21 percent of those children took an antipsychotic medication. The estimates for privately insured children were lower. About 14 percent of children in Medicaid had a potential need for mental health services, and over two-thirds of them did not receive any services. CMS and states have made efforts to ensure that children receive appropriate mental health services, but CMS’s ability to monitor their receipt of services for which they were referred is limited because CMS does not collect information from states on whether children in Medicaid have received services for which they were referred. Our analysis of MEPS data from 2007 through 2009 found that, on average, 6.2 percent of children in Medicaid nationwide—those who were not in institutions or in foster care and were ages 0 through 20—took at least one psychotropic medication during a calendar year. The comparable rate for privately insured children was lower—4.8 percent. The utilization rate was over twice as high for boys as for girls in Medicaid—8.4 percent versus 3.9 percent. There is a higher prevalence among boys of certain mental health disorders for which psychotropic medications are prescribed, which is one possible explanation for this difference. Among children in Medicaid who took psychotropic medications, utilization was highest among youth ages 18 through 20— 12.7 percent—and lowest among children under age 5—less than 1 percent. Utilization rates for privately insured children were highest among children ages 12 through 17—7.5 percent. (See app. III for more- detailed information on children who took psychotropic medications.) Nationwide, almost half of children in Medicaid who took psychotropic medications took multiple psychotropic medications in a 1-year period. Specifically, our analysis found that 28 percent of the children in Medicaid who took psychotropic medications took two medications within a year, and 16 percent took three or more. Among privately insured children who took psychotropic medications, 22 percent took two medications within a year, and 11 percent took three or more. This finding may reflect concomitant use of multiple medications—that is, medications taken in combination—or providers prescribing different drugs over time to find one that works best for the child. The most common types of psychotropic medications taken by children were ADHD medications, antidepressants, and antipsychotics. We found that, of children who took psychotropic medications, about three-fourths took ADHD medications. According to a recent analysis by FDA officials, utilization of ADHD medications increased 46 percent from 2002 to 2010, and methylphenidate, a stimulant used to treat ADHD, was the most commonly prescribed medication for adolescents ages 12 through 17. Antidepressants were the second most common type of medication taken—about one-fourth of the children in Medicaid and one-third of privately insured children who were taking psychotropic medication took an antidepressant. (See table 1.) G. Chai et al., “Trends of Outpatient Prescription Drug Utilization in US Children, 2002- 2010,” Pediatrics, vol. 130, no. 1 (2012). The difference between children in Medicaid and privately insured children was statistically significant. Our analysis also found that children in Medicaid were over twice as likely as privately insured children to take an antipsychotic medication. Overall, about 1.3 percent of children in Medicaid and 0.5 percent of privately insured children took antipsychotics.were covered by Medicaid or private insurance, the majority of children who took an antipsychotic were males ages 6 through 17. Differences between children in Medicaid and those with private insurance were not statistically significant. visits in the same year.medication-management follow-up visit, which pediatric provider organizations recommend. For example, guidelines from the American Academy of Pediatrics state that physicians consider follow-up visits every 3 to 6 months for children taking ADHD medications to monitor the child’s behavior and medication side effects. Our analysis of national survey data from 2007 through 2009 indicated that 14 percent of noninstitutionalized children in Medicaid and 9 percent of noninstitutionalized privately insured children had a potential mental health need. As described earlier, these estimates of potential mental health need are based on a broad measure of a child’s emotional or behavioral impairment, as reported by parents. One possible explanation for the higher level of potential mental health need among Medicaid children could be the lower average family incomes of children enrolled in Medicaid compared to those of children with private insurance. Some studies have found that low income is associated with an increased prevalence of mental health conditions. Our analysis also indicated that most children with a potential mental health need did not receive mental health services, regardless of their insurance type. For example, over 80 percent of children with a potential need, whether covered by Medicaid or private insurance, did not receive any psychosocial therapy, and over 70 percent did not have any mental health office visits. (See table 2.) While it is not possible to assess which services a child may need on the basis of survey data, our analysis indicates that most children whose parents indicated a significant level of behavioral impairment did not even receive a mental health evaluation. Even when a child received at least one mental health service, it is not possible to know whether his or her mental health needs were fully met. About one-fourth of all children with a potential mental health need had a mental health office visit. Among Medicaid children who had mental health office visits, about 40 percent saw a psychiatrist and 30 percent saw a pediatrician at least once in a calendar year. (See table 3.) Just over half of children with any mental health office visits received psychosocial therapy, which suggests that nearly half of all mental health office visits involved another type of service, such as diagnostic assessment or medication management. Among children in Medicaid with at least one mental health office visit, the average number of visits in a year was about seven. CMS has initiated activities to help ensure that children in Medicaid receive appropriate mental health services. For example, CMS has begun working with states to improve their monitoring of the prescribing of psychotropic medications, and in August 2012 the agency issued an Informational Bulletin to states titled, “Collaborative Efforts and Technical Assistance Resources to Strengthen the Management of Psychotropic Medications for Vulnerable Populations.” The bulletin provided a link to additional information on the CMS website that discusses practices some states have employed to enhance the ability of their Drug Utilization Review programs to monitor psychotropic medication prescribing, such as using Drug Utilization Reviews to identify and contact providers whose prescribing patterns vary significantly from recommended standards of care for children.Measures Program, CMS is working with states to collect data on three In addition, through its voluntary Pediatric Quality quality measures related to mental health, including receipt of follow-up care for children prescribed ADHD medication. CMS has also begun working with states to improve access to mental health services through the EPSDT benefit. Most children in Medicaid are entitled to services under EPSDT, which covers regular checkups and screenings as well as treatment services. Children found to have mental health needs at a screening are generally entitled to treatment services to address those needs, whether or not the services are typically covered under the Medicaid program in the child’s state. According to CMS, its National EPSDT Improvement Workgroup has a Behavioral Health Subgroup that is developing an action plan to determine steps CMS can take to work with states to promote access to effective mental health care for children through EPSDT. The agency also told us it plans to issue an Informational Bulletin on children’s behavioral health screening, referral, and treatment, which it will disseminate to state Medicaid agencies and others in early 2013. As required under federal law, states annually submit data to CMS on the provision of services under EPSDT, such as the number of children referred for additional services as a result of checkups and screenings. These data may include referrals for mental health services for children found to have mental health needs during screenings. We previously reported that CMS does not impose requirements beyond this federal law and, accordingly, does not collect information from states on whether children received the services for which they were referred, which limits CMS’s ability to monitor whether children in Medicaid are receiving the services they need. We recommended that CMS work with states to identify options for collecting such information. CMS officials told us that the agency had contracted for a study examining options for collecting data from state Medicaid programs on EPSDT referrals; the study concluded that states were unlikely to be able to produce accurate information on referred services using existing data sources. The officials also said that, as of September 2012, CMS was in the process of identifying alternative approaches for collecting data on children’s receipt of treatment services, such as analyzing national survey data. However, the alternatives currently under consideration would not produce the data from all states that would enable CMS to monitor at the state level children’s receipt of treatment services for which they were referred through Medicaid. States have also made efforts to increase children’s access to mental health services. Because many children receive mental health services from nonspecialists, 28 states have programs to facilitate consultation between primary care providers and child psychiatrists. For example, under Washington state’s Second Opinions program, psychiatrists review Medicaid psychotropic prescriptions that exceed certain safety thresholds—such as dose or use of combinations of medications—and provide a second opinion to the prescribing physician. An evaluation of Washington’s Second Opinions program and its Partnership Access Line—the state’s voluntary program for physicians seeking child psychiatry consultations—found that such consultations are cost-effective and that they have resulted in an increase in referrals for psychosocial therapy and a decrease in prescribing of antipsychotic medications. Similarly, Massachusetts’s program, the Massachusetts Child Psychiatry Access Program, has been found to increase the ability of primary care providers to treat or refer their patients with mental health needs. In a survey of primary care providers participating in the Massachusetts program, 63 percent reported that they were usually able to meet the needs of their psychiatric patients, an increase from only 8 percent of providers before they enrolled in the program. Some states have also begun to integrate mental health services into primary care settings in an effort to increase access to mental health services. For example, through the “State Option to Provide Health Homes for Enrollees with Chronic Conditions,” authorized under the Patient Protection and Affordable Care Act, states have the option to implement person-centered health care delivery systems, known as health homes.render comprehensive services for individuals with chronic conditions, must address mental health and substance abuse treatment needs. According to CMS, a number of states are developing proposals to establish health homes as part of their Medicaid programs, and CMS is providing technical assistance to these states. ACF reported that 18 percent of foster children ages 1 through 19 took psychotropic medications. In addition, ACF found that 30 percent of foster children with a potential mental health need did not receive mental health services in a 12-month period. HHS is taking several steps to promote appropriate mental health treatment for foster children. ACF reported that 18 percent of foster children were taking one or more psychotropic medications at the time they were surveyed, although utilization varied widely by living arrangement.children who lived in group homes or residential treatment centers had much higher rates of psychotropic medication use than foster children ACF reported that foster living in nonrelative foster homes or formal kin care—48 percent versus 14 percent and 12 percent, respectively. The higher utilization rate among children living in group homes or residential treatment centers may be related to these children having higher rates of potential mental health need—about 69 percent had a potential mental health need compared to about 44 percent of children living in nonrelative foster homes. Another study found that child welfare workers were more likely to place children with behavior problems in a group living arrangement than with a foster family. In addition to reporting on overall use of psychotropic medications, ACF reported on concomitant use of psychotropic medications and on the use of antipsychotics by foster children. Among foster children who took psychotropic medication, ACF reported that 13 percent took three or more psychotropic medications concomitantly. 6.4 percent of foster children took an antipsychotic medication and that the majority were ages 6 through 11. Estimates of concomitant use are based on NSCAW II phase 2 data (collected during October 2009 through January 2011). This estimate does not include children in formal kin care. Less than 1 percent of children in formal kin care were taking three or more medications at the time of the survey. Stambaugh et al., OPRE Report #2012-33, 4. ACF reported that 30 percent of foster children with a potential mental health need had not received any mental health services within the previous 12 months or since the start of the child’s living arrangement, if less than 12 months. (See fig. 1.) Although 70 percent of foster children with a potential mental health need received at least one mental health service, it is not possible to know the extent to which the child’s mental health needs were met. In response to concerns related to the prescribing of psychotropic medications for foster children, HHS convened an interagency workgroup on the use of psychotropic medications for foster children in summer 2011. Led by ACF, the workgroup also has representatives from CMS, SAMHSA, NIH, AHRQ, and FDA. The workgroup developed a plan to expand the use of evidence-based screening, diagnosis, and interventions; strengthen the oversight and monitoring of psychotropic medications; and expand the overall knowledge and evidence base regarding medications and psychosocial treatments for foster children with mental health or trauma-related needs. The primary activity of the workgroup is to meet regularly to share information about individual and joint agency activities related to foster children’s mental health. For example, the workgroup convened a meeting in September 2011 with researchers to increase federal staff’s knowledge about psychotropic medication use among foster children, their mental health needs, the extent to which best practices on state oversight and monitoring of psychotropic medications exist, and future data needs. On the basis of the efforts of the workgroup, HHS has identified several areas where more research is needed, including clinical trials related to foster children’s use of psychotropic medications, studies on differences between trauma and mental health diagnoses, and studies on EBTs for foster children. Three member agencies of the workgroup—ACF, CMS, and SAMHSA— have collaborated on certain activities regarding use of psychotropic medications among foster children. In November 2011, the three agencies sent a joint letter to state Medicaid directors, mental health authorities, and child welfare directors. This letter contained information on the three agencies’ activities and resources that aim to improve the mental health and well-being of foster children, such as ACF’s Child Welfare Information Gateway website and SAMHSA’s National Traumatic Stress Initiative grants. These agencies also jointly held several webinars to disseminate this information. In addition, they hosted a summit in August 2012 for state child welfare, Medicaid, and mental health agencies to help states develop psychotropic drug oversight practices and to facilitate interagency coordination for foster children. ACF is also working with CMS to develop quality measures specific to foster children as part of CMS’s Pediatric Quality Measures Program. In addition to participating in the workgroup, ACF is working with states to build the capacity of child welfare agencies to effectively respond to the complex needs of foster children. For example, in addition to overseeing the NSCAW surveys, ACF took the following actions: ACF issued a Program Instruction to help states implement the new requirements in the Child Improvement Act. In the Program Instruction, ACF described five components that state child welfare agencies should include in their plans to monitor psychotropic medications. In addition, the instructions provided guidelines to states on treating and monitoring children experiencing emotional trauma, another requirement of the law. As of August 2012, ACF officials told us that all states had submitted their plans as required by the Child Improvement Act and the agency was reviewing them. ACF published two Information Memoranda for state child welfare agencies—one on promoting social and emotional well-being for children in child welfare and one on best practices in state psychotropic drug oversight. ACF has provided information about psychotropic medication prescribing and monitoring on its Child Welfare Information Gateway—a website that provides resources for child welfare agencies. SAMHSA has provided funding, guidance, and information to states and others to increase appropriate mental health services among foster children. For example: For its fiscal year 2012 National Child Traumatic Stress Initiative grants, SAMHSA placed a specific emphasis on child welfare. The initiative supports services for children experiencing trauma-related behavioral health problems and places a strong focus on using evidence-based psychosocial therapies. SAMHSA worked with AACAP to develop guidance for service providers and agency leaders on the use of psychotropic medications among children, including foster children. Through its Systems of Care grants, SAMHSA has also provided funding for foster children’s mental health services; the agency reported in 2011 that 22 of its grantees had a child welfare focus or a partnership with a child welfare organization. The 2012 SAMHSA-sponsored National Children’s Mental Health Awareness Day event had a special focus on foster children, and SAMHSA is planning a meeting in January 2013 titled “Improving Outcomes for African American Males in Foster Care.” NIH spent about $1.2 billion on research projects related to children’s mental health; NIMH was responsible for most of this funding, with the rest being spent by NICHD. Other HHS agencies—FDA, AHRQ, and CDC—spent an estimated $16 million on external research projects related to children’s mental health. During fiscal years 2008 through 2011, NIH spent about $1.2 billion to support over 1,200 children’s mental health research projects, most of NIMH accounted for 81 percent—about which were supported by NIMH.$956 million—of NIH’s funding for children’s mental health research. (See fig. 2.) NIMH’s $956 million (which represented about 18 percent of NIMH’s total research budget in fiscal years 2008 through 2011) supported slightly over 900 research projects related to mental health in children ages 18 or younger. The most-commonly studied mental health conditions were ADHD, major depression, and bipolar disorder. Nearly all of the projects (97 percent) were conducted externally under grants and contracts, with expenditures of about $861 million. The remaining research projects, for which NIMH spent about $95 million, were conducted internally by NIMH scientists. For example, NIMH scientists used brain imaging techniques to examine how brain development in children with ADHD differed from typical brain development in children. About half of NIMH-sponsored research projects (482) examined mental health treatments for children, with more projects studying psychosocial therapies than psychotropic medications. (See table 4.) Of the 482 treatment research projects, 325 involved testing psychosocial therapies. For example, one project tested the effect of therapies such as parent training and skill building on preventing negative outcomes such as substance use and school truancy in middle-school-aged girls in foster care. Psychotropic medication studies accounted for 137 of the 482 For example, one project tested the effect of an research projects.antidepressant medication on brain activity in children with anxiety disorders, with the goal of better understanding how the medication works. NIMH also funded 66 research projects that tested the effects of combinations of treatments, such as two medications or a medication and a psychosocial therapy. For example, one project tested the effect of parent training—a psychosocial treatment—with and without the addition of a stimulant (or of a stimulant and an antipsychotic medication) on children with a disruptive behavior disorder in combination with ADHD and severe aggression. NIMH officials told us that the agency does not have quotas for the kinds of treatment studies it funds and encourages grant applications from researchers for both psychosocial and psychotropic treatment studies. However, officials noted that NIMH expects to fund more projects examining psychosocial therapies than projects that test medications because researchers may perceive psychosocial therapies to be less risky for children and not all psychotropic medications are approved for pediatric use. NICHD spent about $218 million to sponsor 324 research projects related to mental health in children in fiscal years 2008 through 2011. Almost all projects (98 percent) were conducted externally under grants and contracts, with expenditures of about $195 million. NICHD’s own scientists conducted the remaining research projects, for which NICHD spent about $23 million. Of the 324 research projects, 72 focused on mental health conditions, such as depression and ADHD.NICHD sponsored one study that examined the effectiveness of a mood stabilizing psychotropic medication—lithium—in children ages 7 to 17 with bipolar disorder. For example, NIMH and NICHD collectively spent about $309 million during this period to support almost 350 research projects that examined children’s mental health in minority and health disparity populations. NIMH sponsored 297 such projects, with expenditures of about $283 million, and NICHD spent about $26 million to sponsor 50 projects. For example, NIMH sponsored a study of Latino adolescents with depression that tested the effectiveness of a psychosocial therapy—cognitive behavioral therapy—with and without an additional educational component for parents. NIMH and NICHD also funded translational research, treatments in real world settings and identifies effective strategies for implementing them in communities. For example, NICHD sponsored a research project that evaluated the effectiveness of a psychosocial therapy for girls with post-traumatic stress disorder and concurrent substance abuse disorders who were involved with the juvenile justice system. The study examined ways to adapt the treatment for this population, and the researchers planned to use the study as a model to adapt other EBTs for children involved in the juvenile justice and child welfare systems. The data NIMH and NICHD provided did not identify which projects were translational, so it was not possible to determine the total number of projects or how much was spent on this research. Together, FDA, AHRQ, and CDC spent about $16 million on research projects on children’s mental health in fiscal years 2008 through 2011. FDA spent about $4.5 million on four external research projects on the safety and effectiveness of psychotropic medications for children. For example, FDA cosponsored a study with AHRQ that examined serious cardiovascular events such as heart attack and stroke among children taking ADHD medications. In addition, at the end of fiscal year 2011, FDA awarded a contract for about $6 million for a study on antipsychotic medications and the risk of type 2 diabetes in children; this study is currently under way. AHRQ spent about $8.6 million to fund five external research projects related to children’s mental health in fiscal years 2008 through 2011. Consistent with the agency’s focus on improving outcomes by encouraging the use of evidence to make health care decisions, two of the five research projects AHRQ supported compared outcomes of using different mental health treatments. For example, one AHRQ-sponsored project compared outcomes of using various antipsychotic medications to treat children with ADHD who were enrolled in Medicaid, including children in foster care. Child mental health experts we spoke with highlighted the need for more research that compares different psychotropic medications. For example, one federal official noted that all antidepressant medications bear the same “black box” warning describing the potential for increases in suicidal thinking in childrenis limited information about whether any antidepressants are safer or more effective for children than other antidepressants. CDC spent about $2.7 million on two external research projects during fiscal years 2008 through 2011, one on ADHD and the other on Tourette Syndrome and other tic disorders. The ADHD project examined topics including the prevalence of ADHD, the prevalence of ADHD in combination with other mental health conditions, and children’s utilization of psychosocial and medication treatments. The project on tic disorders also looked at children’s utilization of different kinds of treatments, as well as their school performance, social relationships, and factors associated with poorer functioning. Both projects were designed to include a diverse sample of children with the aim of detecting differences due to sex or race/ethnicity. For example, the ADHD study oversampled girls and included large samples of Black, Latino, and American Indian children. Mental health conditions such as ADHD, depression, and bipolar disorder can have debilitating effects on a child’s life, and early detection and treatment of childhood mental health conditions can improve children’s outcomes into the future. While some children receive highly effective mental health treatments, our findings suggest that many children, including some in Medicaid and in foster care, may not be receiving appropriate treatment. Our analysis of national survey data indicates that concerns raised by providers, children’s advocates, and others about potentially inappropriate prescribing of psychotropic drugs for some children and a lack of needed mental health services for some children may be warranted. Antipsychotic medications are of particular concern in light of the very serious side effects they can have for children, the limited understanding of their long-term effects, and their high cost. Children in Medicaid and in foster care are prescribed these medications at higher rates than other children. Furthermore, most children in Medicaid and many children in foster care with potential mental health needs do not receive mental health services that could help them. Differing rates of medication among the groups of children do not necessarily represent a problem, because potential factors beyond the scope of this review could help explain the differences. Nonetheless, these findings do suggest that the recent federal and state initiatives to improve monitoring and oversight are appropriate, and that continued assessment of the prescribing of psychotropic medications to vulnerable populations and of the receipt of mental health services is important. Initiatives such as CMS’s National EPSDT Improvement Workgroup and plans to help states improve their monitoring efforts, as well as the ACF-led interagency workgroup on the use of psychotropic medications for foster children, have the potential to help ensure that vulnerable children in Medicaid and foster care have access to effective mental health treatments that are appropriate for their mental health conditions. We recommended in 2011 that CMS identify options to collect information from states on whether children in Medicaid receive the services for which they are referred through their EPSDT-mandated screenings and check-ups, which would include referrals for specialty care such as mental health services. CMS has begun to explore options to address this recommendation, but it has not yet identified ways to systematically collect such data from state Medicaid programs. We continue to believe this recommendation is valid, and our findings in this report underscore the importance of HHS’s monitoring the receipt of needed referral and treatment services, including those for mental health, by children in Medicaid. HHS did not comment on our findings but provided technical comments, which we incorporated as appropriate. As arranged with your office, unless you publicly announce the contents of this report earlier, we plan no further distribution until 30 days after its issuance date. At that time, we will send copies of this report to the Secretary of Health and Human Services and other interested parties. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov. If you or your staff members have any questions, please contact me at (202) 512-7114 or iritanik@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. Major contributors to this report are listed in appendix IV. To provide information on the use of psychotropic medications and other mental health services by children covered by Medicaid, the Children’s Health Insurance Program (CHIP), and private insurance, we analyzed nationwide data from the Medical Expenditure Panel Survey (MEPS) from 2007 through 2009. MEPS is a nationally representative survey of families, medical providers, and employers across the United States administered by the Agency for Healthcare Research and Quality (AHRQ). MEPS collects self-reported information on individuals’ demographics, health and insurance status, and use of medical services by setting and provider type, among other things. Specifically, we examined the use of psychotropic medications and mental health-related office visits, therapy visits, and behavioral impairment. We pooled 3 years of data to obtain a sample size large enough to conduct our analyses, and reported average annual estimates. To conduct our analysis, we constructed two cohorts of children who were insured for at least 10 months in 2007, 2008, or 2009—those who were enrolled in Medicaid or CHIP and those covered by private insurance. We included children ages 0 through 20 and excluded children in foster care from our analysis.In total, the sample Medicaid/CHIP cohort had 11,224 children, and the sample private insurance cohort had 11,639 children. The Food and Drug Administration (FDA) is responsible for reviewing the results of pediatric studies conducted under two related laws—the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). BPCA is a program under which manufacturers may receive an additional 6 months of market exclusivity in exchange for conducting pediatric studies. Under PREA, subject to certain exceptions, drug manufacturers must conduct pediatric studies before a drug can be marketed. FDA is responsible for reviewing the results of pediatric studies submitted under BPCA and PREA and ensuring manufacturers incorporate new information on pediatric use into medication labels when required. During fiscal years 2008 through 2011, 168 label changes resulted from studies conducted under these laws, 16 of which were for psychotropic medications. For example, the label for Invega, an atypical antipsychotic medication, was changed to indicate that it is safe and effective for the treatment of schizophrenia in children as young as age 12. (See table 6 for information on all 16 label changes.) In addition to reviewing label changes related to BPCA and PREA, in 2009 FDA began working with manufacturers to change the labels of all atypical antipsychotics to more clearly present data on their metabolic risks for children, which an FDA official said will help prescribers in selecting medications for their patients. Tables 7 and 8 provide estimates of children’s utilization of psychotropic medications and other mental health services, based on our analysis of MEPS data. In addition to the contact named above, Helene F. Toiv, Assistant Director; Laura Brogan; Britt Carlson; Sandra George; Giselle Hicks; Hannah Locke; Roseanne Price; and Hemi Tewarson made key contributions to this report. Foster Children: HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions. GAO-12-201. Washington, D.C.: December 14, 2011. Foster Children: HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions. GAO-12-270T. Washington, D.C.: December 1, 2011. Medicaid and CHIP: Most Physicians Serve Covered Children but Have Difficulty Referring Them for Specialty Care. GAO-11-624. Washington, D.C.: June 30, 2011. Pediatric Research: Products Studied under Two Related Laws, but Improved Tracking Needed by FDA. GAO-11-457. Washington, D.C.: May 31, 2011. Medicaid and CHIP: Reports for Monitoring Children’s Health Care Services Need Improvement. GAO-11-293R. Washington, D.C.: April 5, 2011. Foster Care: State Practices for Assessing Health Needs, Facilitating Service Delivery, and Monitoring Children’s Care. GAO-09-26. Washington, D.C.: February 6, 2009. Prescription Drugs: FDA’s Oversight of the Promotion of Drugs for Off- Label Uses. GAO-08-835. Washington, D.C.: July 28, 2008.

Summary: Experts have concerns that children with mental health conditions do not always receive appropriate treatment, including concerns about appropriate use of psychotropic medications (which affect mood, thought, or behavior) and about access to psychosocial therapies (sessions with a mental health provider). These concerns may be compounded for low-income children in Medicaid and children in foster care (most of whom are covered by Medicaid)--populations who may be at higher risk of mental health conditions. Within HHS, CMS oversees Medicaid, and ACF supports state child welfare agencies that coordinate health care for foster children. GAO was asked to provide information on children's mental health. This report examines (1) the use of psychotropic medications and other mental health services for children in Medicaid nationwide, and related CMS initiatives; (2) HHS information on the use of psychotropic medications and other mental health services for children in foster care nationwide, and related HHS initiatives; and (3) the amount HHS has invested in research on children's mental health. GAO analyzed data from HHS's MEPS --a national household survey on use of medical services--from 2007 through 2009 for children covered by Medicaid and private insurance. GAO reviewed two recent ACF foster care reports with data from a national survey conducted during 2008 through 2011. GAO analyzed data from HHS agencies that conduct or fund research and interviewed HHS officials and children's mental health providers, researchers, and advocates. An annual average of 6.2 percent of noninstitutionalized children in Medicaid nationwide and 4.8 percent of privately insured children took one or more psychotropic medications, according to GAO's analysis of 2007-2009 data from the Department of Health and Human Services' (HHS) Medical Expenditure Panel Survey (MEPS). MEPS data also showed that children in Medicaid took antipsychotic medications (a type of psychotropic medication that can help some children but has a risk of serious side effects) at a relatively low rate--1.3 percent of children--but that the rate for children in Medicaid was over twice the rate for privately insured children, which was 0.5 percent. In addition, MEPS data showed that most children whose emotions or behavior, as reported by their parent or guardian, indicated a potential need for a mental health service did not receive any services within the same year. The Centers for Medicare & Medicaid Services (CMS) and many states have initiatives under way to help ensure that children receive appropriate mental health treatments. However, CMS's ability to monitor children's receipt of mental health services is limited because CMS does not collect information from states on whether children in Medicaid have received services for which they were referred. GAO recommended in 2011 that CMS identify options for collecting such data from state Medicaid programs. Findings in this report underscore the continued importance of CMS's monitoring of children's receipt of mental health services. HHS's Administration for Children and Families (ACF) reported that 18 percent of foster children were taking psychotropic medications at the time they were surveyed, although utilization varied widely by the child's living arrangement. ACF also reported that 30 percent of foster children who may have needed mental health services did not receive them in the previous 12 months. HHS agencies are taking steps to promote appropriate mental health treatments for foster children, such as by sending information to states on psychotropic medication oversight practices. HHS's National Institutes of Health spent an estimated $1.2 billion on over 1,200 children's mental health research projects during fiscal years 2008 through 2011. Most of the funding--$956 million--was awarded by the National Institute of Mental Health, with more research projects studying psychosocial therapies than psychotropic medications. Other HHS agencies spent about $16 million combined on children's mental health research during this period. HHS reviewed a draft of this report and provided technical comments, which GAO incorporated as appropriate.