Foster care begins when a child is removed from his or her parents or guardians and placed under the responsibility of a state child welfare agency. Removal from the home can occur because of physical abuse or neglect. It can also occur when a child’s own behavior or condition is beyond the control of his or her family or poses a threat to their community. Foster care may be provided by a family member, caregivers previously unknown to the child, or a group home or institution. Ideally, foster care is an intermediate step towards a permanent family home. When reuniting the child with his or her parents or guardian is not in the child’s best interest, caseworkers seek a new permanent home for the child, such as an adoptive home or guardianship. However, some children remain in foster care until they reach adulthood. As we have previously reported, children in foster care exhibit more numerous and serious medical conditions, including mental health conditions, than do other children. States are responsible for administering their Medicaid and foster care programs; the programs are overseen at the federal level by HHS through CMS and ACF, respectively. HHS may issue regulations, provide guidance on some issues, or simply provide informational resources for states to consider for their programs, the latter being the case for psychotropic drugs provided to children in state custody. Among these resources are best principles developed by AACAP, a nonprofit professional association. While HHS does not require states to follow these guidelines, AACAP developed them as a model to help inform state monitoring programs for youth in state custody. AACAP guidelines point out that, “as a result of several highly publicized cases of questionable inappropriate prescribing, treating youth in state custody with psychopharmacological agents has come under increasingly intense scrutiny,” leading to state implementation of consent, authorization, and monitoring procedures. More recently, Congress passed the Child and Family Services Improvement and Innovation Act in September 2011, requiring states that apply for certain federal child welfare grants to establish protocols for the appropriate use and monitoring of psychotropic drugs prescribed to foster children. The use of psychotropic drugs has been shown to effectively treat mental disorders, such as attention deficit hyperactivity disorder (ADHD), bipolar disorder, depression and schizophrenia. While many psychotropic drugs that have been approved by the FDA as safe and effective in adults have not been similarly approved for children of all ages, prescribing them to children is legal and common medical practice in many instances. According to the National Institute of Mental Health (NIMH), some children with severe mental health conditions would suffer serious consequences without such medication. However, psychotropic drugs can also have serious side effects in adults, including irreversible movement disorders, seizures, and an increased risk for diabetes over the long term. Further, additional risks these drugs pose specifically to children are not well understood. Psychotropic drugs affect brain activity associated with mental processes and behavior. These drugs are also called “psychotherapeutic” drugs. While psychotropic drugs can have significant benefits for those with mental illnesses, they can also have side effects ranging from mild to serious. Table 1 highlights the psychotropic drug classes studied in this report and provides examples of drugs within those classes, as well as conditions treated and possible side effects. Foster children in each of the five selected states were prescribed psychotropic drugs at higher rates than were nonfoster children in Medicaid during 2008. These states spent over $375 million for prescriptions provided through fee-for-service programs to foster and nonfoster children. The higher rates do not necessarily indicate inappropriate prescribing practices, as they could be due to foster children’s greater exposure to traumatic experiences and the unique challenges of coordinating their medical care. However, psychotropic drug claims for foster children were also more likely to show the indicators of potential health risks that we established with our experts. According to our experts, no evidence supports the concomitant use of five or more psychotropic drugs in adults or children, yet hundreds of both foster and nonfoster children were prescribed such a medication regimen. Similarly, thousands of foster and nonfoster children were prescribed doses exceeding maximum levels cited in guidelines based on FDA-approved drug labels, which our experts said increases the potential for adverse side effects, and does not typically increase the efficacy of the drugs to any significant extent. Further, foster and nonfoster children under 1 year old were prescribed psychotropic drugs, which our experts said have no established use for mental health conditions in infants and could result in serious adverse effects. The kinds of drugs included in prescription data reported to CMS in 2008 varied by state. Because the claims data we obtained from CMS contained fewer types of medications for Michigan and Oregon, we may understate the rates of psychotropic prescriptions for both foster and nonfoster children in those states. While rates of psychotropic prescriptions are not comparable across states, they are comparable between foster and nonfoster children within the same state. Similarly, the ratio of prescriptions to foster children to prescriptions to nonfoster children is comparable across states. history.various age ranges. Comparing the selected states’ monitoring programs for psychotropic drugs provided to foster children with AACAP’s guidelines indicates that, as of October 2011, each of the state programs falls short of providing comprehensive oversight as defined by AACAP. Though states are not required to follow these guidelines, the six states we examined had developed monitoring programs that satisfied some of AACAP’s best principles guidelines to varying degrees. Such variation is not surprising given that states set their own oversight guidelines and have only recently been required, as a condition of receiving certain federal child welfare grants, to establish protocols for the appropriate use and monitoring of psychotropic drugs prescribed to foster children. HHS has provided limited guidance to the states on how to improve their control measures to monitor psychotropic drug prescriptions to foster children. Without formally endorsing specific oversight measures for states to implement, HHS conducts state reviews and provides other online resources, including the AACAP guidelines, to help states improve their programs. ACF performs Child and Family Services Reviews (CFSR) of states to ensure conformity with federal child welfare requirements—which include provisions for safety, permanency, and family and child well-being—and to assist states as they enhance their capacity to help families achieve positive outcomes. These reviews include the examination of a limited number of children’s case files, in part to determine whether the state foster care agency conducted assessments of children’s mental health needs and provided appropriate services to address those needs. However, these reviews are not designed to identify specific potential health risk indicators related to psychotropic medications, and since they occur every 2 to 5 years, states cannot rely on these reviews to actively monitor prescriptions. In addition, ACF operates technical assistance centers and provides online resources such as links to state guidance on psychotropic drug oversight, academic studies on psychotropic drugs, and recordings of teleconferences related to the oversight of psychotropic drugs. While HHS makes a variety of resources available to states developing oversight programs for psychotropic drugs, it has not endorsed any specific guidance. In the absence of HHS-endorsed guidance, states have developed varied oversight programs that in some cases fall short of AACAP’s recommended guidelines. The AACAP guidelines are arranged into four categories, including consent, oversight, consultation, and information sharing, that contain practices defined as minimal, recommended, or ideal. The following describes the extent to which the selected states’ monitoring programs cover these areas. Consent: According to interviews and documentation provided by state Medicaid and foster care officials, all six selected states have implemented some practices consistent with AACAP guidelines for consent procedures, though in varying scope and application. According to AACAP, the consent process should be documented and monitored to ensure that caregivers are aware of relevant information, such as the child’s diagnosis, expected benefits and risks of treatments, common side effects, and potentially severe adverse events. Thus, states that do not incorporate consent procedures similar to AACAP’s guidelines may increase the likelihood that caregivers are not fully aware of the risks and benefits associated with the decision to medicate with psychotropic drugs, and may limit the caregiver’s ability to accurately assess and monitor the foster child’s reaction to the drugs. Table 4 lists AACAP’s guidelines relative to consent and illustrates the extent to which states have implemented those guidelines. Florida and Michigan provide examples of how states vary in their approach to monitoring consent procedures used for psychotropic drugs prescribed to foster children. For example, Florida requires all prescribers to obtain a standardized written consent form from the parental or legal guardian, or a court order, before a psychotropic drug is administered. The consent form includes the diagnosis, dosage, target symptoms, drug risks and benefits, drug monitoring plan, alternative treatment options, and discussions about the treatment between the child and the parent or legal guardian. Florida law identifies who is authorized to give consent, and obtains assent for psychotropic drug management from minors when age and developmentally appropriate. Florida provides required training to caseworkers, but the names and indications for use of commonly prescribed psychotropic drugs are not included. In contrast, Michigan has policies identifying who is authorized to give consent to foster children, but does not use a standardized consent form that can be used to help inform consent decisions. Instead, Michigan requires that caseworkers maintain in their files the consent forms used by individual prescribers, which likely vary in content and may thus vary in helpfulness to consent givers. Moreover, Michigan does not have training requirements in place to help caseworkers, court personnel, and foster parents become more effective advocates for children in their custody. Training for caseworkers is optional, but according to an agency official, the training was unavailable because no trainer had been hired as of September 2011. Michigan does not have policies for obtaining assent from minors when possible, thus meeting only one of AACAP’s guidelines for consent procedures. Oversight procedures: Each of the six states has developed some procedures similar to AACAP’s guidelines for overseeing psychotropic drug prescriptions for foster children, as evidenced by interviews and documentation provided by state Medicaid and foster care officials. According to one study, states that implement standards to improve oversight of the use of psychotropic drugs may create enhanced continuity of care, increased placement stability, reduced need for psychiatric hospitalization, and decreased incidence of adverse drug reactions. As such, states that do not incorporate oversight procedures similar to AACAP’s recommendations limit their ability to identify the extent to which potentially risky prescribing is occurring in the foster care population. Table 5 lists AACAP’s guidelines relative to oversight and illustrates the extent to which selected states have implemented those guidelines. Texas and Maryland provide examples of how states vary in their approach to oversight of psychotropic drug use among foster children. For example, the Texas Department of Family and Protective Services (DFPS) and the University of Texas at Austin College of Pharmacy assembled an advisory committee that included child and adolescent psychiatrists, psychologists, pediatricians, and other mental health professionals to develop psychotropic drug use parameters for foster children. These parameters are used to help identify cases requiring additional review. Factors that trigger additional reviews include dosages exceeding usual recommended levels, prescriptions for children of very young age, concomitant use of five or more psychotropic drugs, and prescriptions by a primary care provider lacking specialized training. According to the Texas foster care agency’s data analysis, after Texas released these guidelines in 2005, psychotropic drug use among Texas foster care children declined from almost 30 percent in fiscal year 2004 to less than 21 percent in fiscal year 2010. Texas also analyzes Medicaid claims data to monitor psychotropic drug prescriptions for foster children and to identify any unusual prescribing behaviors. Texas provides quarterly reports to child welfare officials on the use of psychotropic drugs among foster children and treating clinicians have access to a child’s medical records on a 24-hour basis. However, the electronic health record system does not always capture the child’s height, weight, and allergies, which is optional for prescribers to enter into the system. This information is helpful as a child’s weight may be used to determine the recommended dose for some medications, while allergy information may be used to determine whether a child should take a particular medication. In addition, ongoing medical problems are not recorded in the electronic health record system and Texas does not measure the rate of adverse reactions at the macro level among youth in state custody. Maryland fully applies only one of the six AACAP guidelines for oversight procedures and partially applies others. Maryland provides foster children in out-of-home placement with a “medical passport” that serves as a record of the child’s previous and current medical file. Each topic included in AACAP’s guidelines for maintaining ongoing medical records, including diagnoses, allergies, and medical history, is documented in the passport, and an additional copy of the passport is kept in the child’s case record and maintained electronically. However, Maryland has not produced any specific guidelines for the use of all psychotropic prescriptions among foster children, thus limiting the state’s ability to identify potentially risky prescribing practices for the foster child population. Without guidelines for psychotropic drugs, there are no criteria to help agency officials monitor the appropriateness of prescriptions. Moreover, Maryland does not review Medicaid claims data statewide specifically for foster children, and therefore does not produce quarterly reports to identify the rate and types of drugs used in the foster care population that could help identify and monitor prescribing trends. In addition, as stated earlier, Maryland’s 2008 foster care data were found unreliable. Maryland officials told us that transitioning to a new records system in 2007 resulted in incorrect and missing data for foster children. Consultation program: According to interviews and documentation provided by state Medicaid and foster care officials, five of the six states have implemented some of AACAP’s guidelines for consultation, but only one of the six selected states has implemented a consultation program that ensures all consent givers and prescribers are able to seek advice from child and adolescent psychiatrists before making consent decisions for foster children. States that do not have a consultation program to help link consent givers and prescribers with child and adolescent psychiatrists may reduce the extent to which prescribers and consent givers are informed about the expected benefits and risks of treatments, alternative treatments, and the risks associated with no treatment. Table 6 lists the AACAP guidelines relative to consultation programs and illustrates the extent to which selected states have implemented those guidelines. Massachusetts and Oregon provide examples of how states vary their approach in providing expert consultations to caregivers. For example, Massachusetts’s foster care agency started an initiative to connect child welfare staff to Medicaid pharmacists who can provide information on medications and the foster child’s drug history, including interactions between any current and proposed drugs. In addition, primary care physicians who treat children, including foster care children, also have access to the state-funded Massachusetts Child Psychiatry Access Project, a system of regional children’s mental health consultation teams designed to help pediatricians find and consult with child psychiatrists. Massachusetts has six child psychiatrists who are available to provide consultations on a part-time basis to child welfare staff, but these consultations are not available for other consent givers such as foster parents. The foster care agency’s consultation program also provides face-to-face evaluations of foster children at the request of consent givers concerned about a child’s treatment. In early 2009, Oregon put a consultation program in place to help consent givers make informed decisions. In 2010, Oregon’s foster care agency shifted the responsibility for all consent decisions where the agency has legal custody or is the legal guardian of the child from foster parents to child welfare agency officials, who now have access to a child and adolescent psychiatrist and can seek consultations before making consent decisions. However, the consultation program does not conduct face-to-face evaluations of children—by a child and adolescent psychiatrist—at the request of consent givers, nor does it enable prescribing physicians to consult with child and adolescent psychiatrists. Oregon has plans for the development of the Oregon Psychiatric Access Line for Kids, which would allow primary care physicians and nurse practitioners to consult with child psychiatrists, but agency officials told us the program is not operational due to a lack of funding. Information sharing: Four of the six selected states have created websites with information on psychotropic drugs for clinicians, foster parents, and other caregivers. Access to comprehensive information can help ensure that clinicians, foster parents, and other interested parties are fully informed about the use and management of psychotropic drugs. Table 7 lists AACAP’s guidelines relative to information sharing and illustrates the extent to which selected states have implemented those guidelines. For example, Florida’s foster care agency has partnered with the University of South Florida to implement Florida’s Center for the Advancement of Child Welfare Practice to provide needed information and support to Florida’s professional child welfare stakeholders. The program’s website is consistent with four of AACAP’s six guidelines for information sharing. For example, the website includes policies and procedures governing psychotropic drug management, staff publications and educational materials about psychotropic drugs, consent forms, and links to other informative publications and news stories related to foster children and psychotropic drugs. However, the website does not provide reports on prescription patterns for psychotropic drugs or adverse effect rating forms. In comparison, Oregon’s foster care agency developed a website that includes information regarding psychotropic medication, but the website is not updated regularly to operate as an ongoing information resource. The website currently has information on state policies and procedures governing the use of psychotropic drugs and also contains web links to consent forms and a medication chart that can be used as a psychotropic medication reference tool. However, the website does not meet three of the six information-sharing guidelines, including those on posting adverse effect rating forms, reporting prescription patterns, and providing links to other informative websites. States with less accessibility to comprehensive information may limit the extent to which physicians, foster parents, and other interested parties are informed about the use and management of psychotropic drugs. The higher rates of psychotropic drug prescriptions among foster children may be explained by their greater mental health needs and the challenges inherent to the foster care system. However, thousands of foster and nonfoster children in the five states we analyzed were found to have prescriptions that carry potential health risks. While doctors are permitted to prescribe these drugs under current laws, increasing the number of drugs used concurrently and exceeding the maximum recommended dosages for certain psychotropic drugs have been shown to increase the risk of adverse side effects in adults. Prescriptions for infants are also of concern, due to the potential for serious adverse effects even when these drugs are used for non-mental health purposes. Comprehensive oversight programs would help states identify these and other potential health risks and provide caregivers and prescribers with the information necessary to weigh drug risks and benefits. The recently enacted Child and Family Services Improvement and Innovation Act requires states to establish protocols for monitoring psychotropic drugs prescribed to foster children. Under the act, each state is authorized to develop its own monitoring protocols, but HHS-endorsed, nationwide guidelines for consent, oversight, consultation, and information sharing could help states close the oversight gaps we identified and increase protections for this vulnerable population. In our draft report, we recommended that the Secretary of HHS evaluate our findings and consider endorsing guidance to state Medicaid and child welfare agencies on best practices for monitoring psychotropic drug prescriptions for foster children, including guidance that addresses, at minimum, informed consent, oversight, consultation, and information sharing. We have received written comments on our draft report from HHS and relevant agencies in 6 states. In written comments, HHS agreed with our recommendation and provided technical comments, which we incorporated as appropriate. In written comments and exit conferences, staff from state Medicaid and foster care agencies provided comments on key facts from the report. Agency comments will be incorporated and addressed in a written report that will be issued in December 2011. Chairman Carper, Ranking Member Brown, and Members of the Subcommittee, this completes my prepared statement. I would be pleased to respond to any questions that you may have at this time. For additional information about this testimony, please contact Gregory D. Kutz at (202) 512-6722 or kutzg@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this statement. Appendix I: Print-friendly version of figure 1 and figure 2 This is a work of the U.S. government and is not subject to copyright protection in the United States. The published product may be reproduced and distributed in its entirety without further permission from GAO. 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Summary: Foster children have often been removed from abusive or neglectful homes and tend to have more mental health conditions than other children. Treatment may include psychotropic drugs but their risks to children are not well understood. Medicaid, administered by states and overseen by the Department of Health and Human Services (HHS), provides prescription drug coverage to foster children. This testimony examines (1) rates of psychotropic prescriptions for foster and nonfoster children in 2008 and (2) state oversight of psychotropic prescriptions for foster children through October 2011. GAO selected Florida, Maryland, Massachusetts, Michigan, Oregon, and Texas primarily based on their geographic diversity and size of the foster care population. Results cannot be generalized to other states. In addition, GAO analyzed Medicaid fee-for-service and foster care data from selected states for 2008, the most recent year of prescription data available at the start of the audit. Maryland's 2008 foster care data was unreliable. GAO also used expert child psychiatrists to provide a clinical perspective on its methodology and analysis, reviewed regulations and state policies, and interviewed federal and state officials. Foster children in the five states GAO analyzed were prescribed psychotropic drugs at higher rates than nonfoster children in Medicaid during 2008, which according to research, experts consulted, and certain federal and state officials, could be due in part to foster children's greater mental health needs, greater exposure to traumatic experiences and the challenges of coordinating their medical care. However, prescriptions to foster children in these states were also more likely to have indicators of potential health risks. According to GAO's experts, no evidence supports the concomitant use of five or more psychotropic drugs in adults or children, yet hundreds of both foster and nonfoster children in the five states had such a drug regimen. Similarly, thousands of foster and nonfoster children were prescribed doses higher than the maximum levels cited in guidelines developed by Texas based on FDA-approved labels, which GAO's experts said increases the risk of adverse side effects and does not typically increase the efficacy of the drugs to any significant extent. Further, foster and nonfoster children under 1 year old were prescribed psychotropic drugs, which GAO's experts said have no established use for mental health conditions in infants; providing them these drugs could result in serious adverse effects. Selected states' monitoring programs for psychotropic drugs provided to foster children fall short of best principle guidelines published by the American Academy of Child and Adolescent Psychiatry (AACAP). The guidelines, which states are not required to follow, cover four categories. (1) Consent: Each state has some practices consistent with AACAP consent guidelines, such as identifying caregivers empowered to give consent. (2) Oversight: Each state has procedures consistent with some but not all oversight guidelines, which include monitoring rates of prescriptions. (3) Consultation: Five states have implemented some but not all guidelines, which include providing consultations by child psychiatrists by request. (4) Information: Four states have created websites about psychotropic drugs for clinicians, foster parents, and other caregivers. This variation is expected because states set their own guidelines. HHS has not endorsed specific measures for state oversight of psychotropic prescriptions for foster children. HHS-endorsed guidance could help close gaps in oversight of psychotropic prescriptions and increase protections for these vulnerable children. In our draft report, GAO recommended that HHS consider endorsing guidance for states on best practices for overseeing psychotropic prescriptions for foster children. HHS agreed with our recommendation. Agency comments will be incorporated and addressed in a written report that will be issued in December 2011.