About 2 million of the more than 6 million veterans who received VHA services in fiscal year 2018 had at least one diagnosed mental health condition, with MDD being the most prevalent diagnosis. About half of these approximate 2 million veterans had a single mental health condition while the remaining half had multiple mental health conditions (see fig. 1). In fiscal year 2018, the three most prevalent mental health conditions among veterans using VHA services were MDD (15 percent), PTSD (12 percent), and GAD (3 percent): MDD. This condition is the most prevalent and disabling form of depression. In addition to the immediate depression symptoms (such as persistently feeling sad or anxious, loss of interest in activities, and difficulty sleeping or oversleeping), MDD can result in poor quality of life overall and decreased productivity, and increased risk of suicide. PTSD. Those with PTSD have experienced symptoms that have persisted for more than 1 month after exposure to a traumatic event, although the onset of symptoms may be delayed for much longer, and cause significant distress or impairment in social, occupational, or other important areas of functioning. Symptoms may include recurrent, involuntary memories of the traumatic event and flashbacks in which the veteran feels or acts as if the traumatic event were recurring. PTSD is strongly associated with reduced quality of life and adverse physical health outcomes. GAD. Those with GAD feel continually worried or anxious about a range of events or activities in their daily lives and have difficulty controlling or stopping this worry. Along with feeling worried, those with GAD experience symptoms of tension such as restlessness, feeling on edge, being easily tired, difficulty concentrating, and sleep difficulties. Veterans with mental health conditions may be offered a variety of treatment options. Of the approximate 2 million veterans with at least one diagnosed mental health condition in fiscal year 2018, 45 percent received non-pharmacologic therapy, 27 percent received a combination of non-pharmacologic therapy and psychotropic medication, and 10 percent received psychotropic medication only. Non-pharmacologic therapy. Non-pharmacologic therapy, or psychotherapy, involves treating mental health conditions using psychological rather than medical means. There are many different types of therapy options, although not all may be available at every VAMC. Examples of non-pharmacologic therapies include cognitive behavioral therapy and prolonged exposure therapy. Some therapy options may be provided to individual veterans, while others are offered to groups of veterans. Psychotropic medications. Psychotropic medications are used to affect one’s mood, thought, or behaviors. Veterans can be prescribed one or more psychotropic medications, from one or more classes, to treat their diagnosed mental health conditions. For example, sertraline—a psychotropic medication commonly known by its brand name Zoloft®—is used by VHA providers to treat both depression and anxiety. Combining treatment. Providers may decide to offer both psychotropic medications and non-pharmacologic therapy, rather than prescribing or offering either option alone. Decisions to offer any of these treatment options are made by providers in various VAMC outpatient care settings. Primary care setting. In addition to addressing other health care needs, PCPs may order non-pharmacologic treatment, prescribe psychotropic medications, or combine both treatment options to address a veteran’s mental health conditions. Through the primary care-mental health integration (PC-MHI) model, which VAMCs began implementing in 2007, PCPs may also collaborate with mental health providers (e.g., psychologists, social workers, nurses) who are collocated within the primary care clinic before making treatment decisions. These collocated mental health providers can also offer non-pharmacologic therapy to veterans without requiring a separate visit outside of primary care. Specialty care setting. Mental health providers in a specialty care setting, such as psychiatrists, decide whether to provide any type of treatment for veterans who have been referred to them by providers in primary care for services specific to their mental health conditions. Veterans may also seek services from a mental health provider in specialty care without first obtaining a referral from primary care. VHA has established certain requirements for providers’ documentation of specialty mental health care treatment plans, and the Joint Commission periodically reviews the documentation of such plans to ensure that they align with the Commission’s standards. VHA. To ensure that providers develop appropriate approaches to treating veterans with mental health conditions and reevaluate such treatment approaches over time, VHA has established certain policies to govern the documentation of mental health treatment decisions by mental health providers in specialty care. For example, in 2008, VHA issued its mental health services handbook to define minimum clinical requirements for mental health services at VAMCs, requiring that providers in specialty care document mental health treatment plans in veterans’ electronic medical records. The mental health services handbook specifies that plans should include certain components such as documentation that different evidence-based treatment options were considered by mental health providers and that approaches to monitor the outcomes of care were developed. The Joint Commission. The Joint Commission is an independent, not-for-profit organization responsible for accrediting and certifying health care organizations and programs in the United States (including VAMCs) at least once every 3 years, and it has developed standards to use as the basis of its evaluative process. These standards focus on specific patient and organization functions that are essential to providing safe and high-quality care, including plans for treatment provided in mental health care settings. VAMC officials we interviewed reported various factors as contributing to providers’ decisions to prescribe psychotropic medications and offer non- pharmacologic therapy to veterans. Specifically, officials from multiple VAMCs cited each of the following factors as contributing to treatment decisions: VAMC resources, complexity of veterans’ mental health conditions, comfort level of providers with treating conditions or prescribing medications, veterans’ preferences, and logistics of receiving mental health treatment. See table 2 for the factors and supporting examples offered by VAMC officials during our site visits. In our review of documentation VAMC providers may use when making treatment decisions, we identified some additional factors. For example, providers’ use of clinical practice guidelines (CPG) established by VA and the Department of Defense may contribute to providers’ treatment decisions. Specifically, the CPG for mental health conditions that are highly prevalent among veterans, including MDD and PTSD, are a resource that all VAMC providers may use when making treatment decisions. For example, the CPG for the management of MDD recommends that providers offer either psychotropic medications or non- pharmacologic therapies (such as behavioral therapy) for the primary treatment of uncomplicated MDD. In contrast, the CPG for the management of PTSD recommends initial treatment for this condition to be a specific type of non-pharmacologic therapy (individual trauma- focused therapy), and when this therapy is not readily available or preferred, then treatments include prescribing psychotropic medications or offering another form of non-pharmacologic therapy. Though it is not mandatory for providers to follow the recommendations of the CPGs, which are based on the strength of evidence and also the potential benefits and harms of treatment options, every provider is responsible for evaluating the appropriateness of applying CPG recommendations in any particular clinical situation. Another factor we identified in our review of documentation was service agreements that VAMCs have in place to help coordinate mental health services across outpatient settings. All five of the VAMCs in our review have formal agreements to help coordinate mental health services across outpatient settings to help manage VAMC resources. These agreements indicate that, for example, providers in primary care can provide treatment for certain mental health conditions, such as uncomplicated depression, without referring veterans to mental health providers in specialty care (see text box). Service Agreements between Primary and Specialty Care for the Treatment of Mental Health Conditions in Selected VA Medical Centers (VAMC) All five of the VAMCs in our review have formal service agreements to help coordinate treatment across primary and specialty care settings for certain mental health conditions, such as uncomplicated depression: All service agreements from the VAMCs in our review indicated that providers in primary care can treat uncomplicated depression without referring veterans to a mental health provider in a specialty care setting. All service agreements indicated at what point mental health providers in specialty care should be involved to help treat veterans with uncomplicated depression—for example, if veterans failed to respond to treatment after trying two different psychotropic medications, or if symptoms worsen over time. In addition to uncomplicated depression, other mental health conditions (including anxiety, PTSD, schizophrenia, and bipolar disorder) were addressed in four of the five service agreements we reviewed. For example, the four service agreements indicated that veterans with bipolar disorder should be treated by mental health providers in specialty care. In light of these factors, providers we interviewed reported on the extent to which each of the most prevalent mental health conditions resulted in PCPs prescribing medication to veterans prior to or without being referred to specialty care. Specifically, more providers reported that psychotropic medications are commonly prescribed to veterans with MDD, PTSD, or GAD prior to referring them to specialty care compared to providers who reported that it is common to prescribe without referring veterans to specialty care at all. See figure 2 for the percentages of providers reporting that psychotropic medications are commonly prescribed to veterans with these three conditions prior to referring them to specialty care. Providers also reported on the extent to which it was common for any provider to offer non-pharmacologic therapy to veterans with these three conditions in lieu of, or in addition to, prescribing psychotropic medications. More providers reported that non-pharmacologic therapy is commonly offered in addition to psychotropic medications compared to providers who reported that it is common to offer therapy instead of medication. See figure 3 for the percentages of providers reporting that non-pharmacologic therapy is commonly offered in addition to psychotropic medications. See appendix I for additional information about mental health treatment practices, including the prescribing of psychotropic medications and offering non-pharmacologic therapy to veterans in a random, nongeneralizable selection of medical records from the VAMCs in our review. See appendix II for information on the use of psychotropic medications or non-pharmacologic therapy by VHA providers to treat veterans with certain mental health conditions, nationally, in fiscal year 2018. VHA has not developed and disseminated guidance that specifies its expectation that mental health providers in specialty care document treatment plans in an easily identifiable way within veterans’ medical records. According to VHA officials responsible for overseeing mental health services, mental health providers should be documenting treatment plans in notes that are easily identifiable and separate from other health information, rather than embedding the plans in progress notes where they may combined with other information related to veterans’ medical histories and current health conditions. In our nongeneralizable review of 80 medical records for veterans who were seen by providers in specialty care and prescribed a psychotropic medication, we found that a majority (50) had a mental health treatment plan recorded in a progress note. We viewed several examples where the treatment plan was not the only information recorded within the progress note, making it difficult to readily identify the mental health treatment plan itself. A VHA official responsible for overseeing mental health services told us it is important for a mental health provider in specialty care to document each veteran’s treatment plan in such a manner so that the provider, or any other providers who may become involved in the veteran’s treatment, can readily refer to the plan as they evaluate progress. This may be particularly important during transitions between inpatient and outpatient care settings, or when adding providers to a veteran’s care team. Providers need to be able to readily access veterans’ mental health treatment plans to ensure that treatment is being provided as ordered, understand why certain treatments were decided against, and assess whether treatment changes are needed. The same VHA official told us that he encourages this practice to support VAMC compliance with the Joint Commission’s standards for mental health treatment plans. However, relevant VHA guidance documents for mental health providers do not specify this expectation: VHA mental health services handbook. The VHA mental health services handbook, published in 2008, requires that mental health providers in specialty care document treatment plans that include certain components. However, it does not specify where providers should document such plans within veterans’ medical records. VHA memo. A 2012 VHA memo promotes the use of a software program by mental health providers in specialty care that, according to VHA officials, facilitates the documentation of treatment plans in notes that are easily identifiable and separate from other information. However, the memo did not specifically state that documenting treatment plans in easily identifiable and separate locations from other information is the goal of using the software program, nor does the memo require providers to use the software. VHA health records handbook. This handbook, published in 2015, provides basic health information procedures for managing veterans’ health records and specifies that all outpatient providers must include treatment plans in progress notes. It does not explicitly reflect VHA’s expectation for mental health providers in specialty care to document mental health treatment plans in an easily identifiable way. Further, the health records handbook specifies that progress notes must also include other types of information, including the history of the veteran’s medical problem, the provider’s assessment of the problem, any tests or consults ordered, and instructions given to the veteran. VHA officials did not provide a rationale as to why they have not developed guidance that clearly directs mental health providers in specialty care to document treatment plans in an easily identifiable way within veterans’ medical records. They noted that VHA has relied upon the VAMCs to develop local processes for documenting specialty mental health treatment plans in an easily identifiable way when providers decide not to use the software program that VHA promoted in its 2012 memo. According to VHA officials, VHA is developing a new memo to communicate its expectation that mental health providers in specialty care document treatment plans in an easily identifiable way within veterans’ medical records. However, as of March 2019, VHA officials had not finalized this memo or indicated when the memo will be disseminated. Standards for internal control in the federal government require that agencies document responsibilities through policies and define objectives in terms that are understood at all levels. These standards also require that agencies communicate necessary information throughout all agency reporting lines to achieve the agencies’ objectives. Absent VHA guidance that clearly identifies its expectation for documenting specialty mental health treatment plans, providers may incorrectly record treatment plans in veteran’s electronic medical records such that they are not easily identifiable. As a result, there is a risk that a provider may be unable to readily access important information about a veteran’s mental health treatment, including the use of psychotropic medication or non- pharmacologic therapy, during changes in a veteran’s care. VHA may learn of the extent of this risk through efforts to collect information resulting from the Joint Commission’s accreditation survey process. Specifically, VHA uses various conference calls to discuss the Joint Commission accreditation survey process and results: According to a VHA official, VHA has weekly and quarterly conference calls with VISNs to, in part, help them prepare their VAMCs for future surveys and, as a result, VHA may learn about different types of citations that apply to multiple VAMCs. This, in turn, may allow VHA to identify concerns that may need to be addressed system-wide, including those related to mental health treatment planning. The Joint Commission provides VHA with an annual summary of data on common citations issued to VAMCs. According to the Joint Commission officials, the Commission provides VHA with this information through a conference call, which may also include a discussion of the underlying causes for any trends in system-wide citations. VHA officials may be able to use this information to address any systemic problems related to the documentation of specialty mental health treatment plans in an easily identifiable way within veterans’ medical records. According to a VHA official, VHA has not identified the documentation of specialty mental health treatment plans as an area for improvement across VAMCs. This issue was not included in the November and December 2018 conference calls with the VISNs, nor was it included in the 2018 annual summary of data that the Joint Commission provided to VHA. VHA has not developed or implemented an approach for monitoring whether mental health providers in specialty care are documenting their consideration of different evidence-based treatment options in mental health treatment plans as required by VHA’s mental health services handbook. In our review of a nongeneralizable sample of 80 medical records for veterans who were seen by such providers and prescribed a psychotropic medication, we found that none of the veterans had treatment plans that documented consideration of different evidence- based treatment options for the veterans’ mental health conditions. VHA relies on the Joint Commission to assess mental health treatment plans as part of the organization’s accreditation process for each VAMC, according to VHA officials. However, VHA does not obtain information resulting from the Joint Commission’s accreditation process that specifically relates to whether mental health providers are documenting consideration of different treatment options in their mental health treatment plans as required. The Joint Commission’s accreditation standards related to mental health treatment plans align with some, but not all, of VHA’s mental health services handbook’s required treatment plan components. For example, the standards align with VHA’s requirement that mental health providers in specialty care must document how they plan to track outcomes and re-evaluate treatment when needed. However, they do not call for the Joint Commission’s accreditation survey to assess whether specialty mental health treatment plans include providers’ consideration of different treatment options, and, according to organization officials, this is not something they look for when conducting their reviews. VHA’s mental health services handbook calls for monitoring through the use of metrics to ensure implementation of the handbook’s requirements, including those related to the documentation of the mental health treatment plan components by mental health providers in specialty care. Additionally, standards for internal control in the federal government require that agencies establish appropriate performance measures for defined objectives, perform ongoing monitoring activities, and remediate identified deficiencies on a timely basis. VHA’s lack of monitoring may contribute to inadequate documentation of the treatment options considered by mental health providers in specialty care in accordance with the mental health services handbook’s requirements. As a result, VHA cannot ensure that mental health providers in specialty care are appropriately considering all available evidence-based treatment options to provide the best care for veterans. This monitoring may be accomplished, for example, by establishing metrics and monitoring performance against such metrics, as called for by VHA’s mental health services handbook. Without metrics or other approaches to monitoring, VHA officials may not be identifying and addressing any systemic problems related to consideration of different evidence-based treatment options. VHA has reported improvement in the safe and effective prescribing of certain psychotropic medications used to treat veterans with mental health conditions since the 2013 start of its Psychotropic Drug Safety Initiative (PDSI). To date, PDSI has consisted of three phases, with each phase focusing on different classes or types of psychotropic medications, age groups, or mental health conditions and substance use disorders. PDSI is currently in phase 3 and VHA is in the process of planning for a new phase 4, scheduled to begin in July 2019. For each phase, VHA developed a set of performance metrics from which each VAMC was required to select a designated number as a focus for implementing prescribing-related quality improvement efforts (referred to as the VAMC’s priority metrics). See table 3. VHA reported improvements in the majority of the performance metrics from the past PDSI phases. Specifically, VHA reported nationwide improvements in 16 of the 20 metrics that it developed for phase 1, and all 14 of the metrics that it developed for phase 2. For example, upon the completion of phase 1, VHA found that there was a nationwide 5.4 percentage point decrease (indicating improvement on this metric) in the percentage of veterans with PTSD who received one or more outpatient prescriptions for a benzodiazepine (a type of antianxiety medication). VHA reported that the change in benzodiazepine prescribing, among other improvements in treating veterans with PTSD, was particularly noteworthy given that the number of veterans diagnosed with this mental health condition increased over the duration of phase 1. Further, upon the completion of phase 2, VHA found that there was a nationwide 1.7 percentage point decrease (indicating improvement on this metric) in the percentage of veterans 75 or older with an outpatient prescription for a benzodiazepine or sedative hypnotic medication. During each PDSI phase, VHA works with VISNs and VAMCs to support their quality improvement efforts related to their priority metrics. For example, VHA provides feedback and technical assistance to VISNs and VAMCs for developing and implementing quality improvement strategies for their priority metrics, which must be updated and submitted to VHA semiannually; convenes a bi-monthly PDSI conference call for VISN and VAMC staff and providers involved in PDSI, which serves as a forum for providing training to participants, discussing best practices, and facilitating collaboration among VAMCs that may have chosen the same priority metrics; develops a semi-annual feedback report for each VISN that includes, among other content, the most recent quarterly score on the priority performance metrics for each VAMC within the network, according to a VHA official; and provides VISNs and VAMCs access to a PDSI clinical management dashboard to use to identify veterans who may benefit from changes to their psychotropic medication prescriptions. These lists can be filtered by the care setting in which the patient is seen, such as the primary or specialty care settings. Although VISNs and VAMCs are not always required (but are encouraged) to continue quality improvement efforts related to VAMCs’ priority metrics from past PDSI phases, VHA continues to monitor VAMC performance on all metrics from each PDSI phase. Specifically, a VHA official told us that VHA monitors performance by calculating quarterly VAMC scores on all performance metrics, which are published on the PDSI clinical management dashboard. VHA also disseminates these scores to the VISNs in the semiannual feedback reports. In these feedback reports, VHA highlights any metric—from the current or a past phase—for which a VAMC within that VISN has regressed. A VHA official stated that if a VAMC regresses significantly in any area, VHA would work with that medical center to determine the cause and take action to reverse the trend as needed. See appendix III for information on PDSI’s planned focus on reducing the co-prescribing of benzodiazepines and opioids as well as the initiative’s collaboration with VHA’s Academic Detailing program, which has developed its own campaign related to stimulant prescribing. Since 2012, VHA has included psychotropic medications in multiple efforts to examine suicide risk among veterans, including two programs and three research studies. These efforts include: Recovery Engagement and Coordination for Health – Veterans Enhanced Treatment (REACH VET) Program. VHA includes psychotropic medications as part of its effort to examine veterans who may be at risk of suicide through its REACH VET program. Specifically, REACH VET uses prior research findings to conduct predictive modeling on data collected from VHA’s electronic medical records to identify veterans who are within the top tier (0.1 percent) of predicted suicide risk. These veterans may also be at increased risk of other adverse outcomes, such as overdoses, violence, and mental health hospitalization. Of note, five of the 61 variables used in REACH VET’s predictive model relate to the prescription of specific psychotropic medications (e.g., alprazolam), and three relate to the prescription of specific psychotropic classes (e.g., antidepressants). Other variables used in the model include demographic characteristics, past suicide attempts, measures of VHA care utilization, and certain diagnoses such as substance use disorder, MDD, and chronic pain. REACH VET coordinators staffed at VAMCs are responsible for notifying the appropriate mental health provider or PCP that a veteran has been identified as being at high risk for suicide, based on a high-risk list of veterans generated monthly by REACH VET’s predictive model. As shown in Figure 4, veterans identified as being at high risk for suicide may then receive targeted outreach from their mental health providers or PCPs if those providers conclude that outreach is warranted based on their review of the veterans’ medical records, according to VHA officials. This outreach may result in changes to the veteran’s treatment as agreed upon by the provider and veteran. VHA reported that within the first year of nationwide implementation, February 2017 through February 2018, the program identified close to 30,000 veterans at high risk for suicide. Behavioral Health Autopsy Program. VHA also includes psychotropic medications in its Behavioral Health Autopsy Program. This program examines information about veteran deaths by suicide that are reported to VAMC providers and suicide prevention coordinators. When informed that a veteran has died by suicide, suicide prevention coordinators are to electronically report, among other things, whether the veteran had (1) been prescribed psychotropic and other medications, for the treatment of a mental health condition within the previous year, and (2) adhered to the medications. Other sources of information collected through the program may include coroners’ and medical examiners’ reports, death certificates, and information provided by family members and significant others. Data are reported to and analyzed by VHA’s VISN 2 Center of Excellence for Suicide Prevention. One recommendation in the program’s 2017 annual report called for more efforts to study issues related to medication management, such as veterans’ medication adherence, overmedication, and frequent and abrupt medication changes. In the past, recommendations from the program have been used to inform VHA suicide prevention policies, programs, and educational efforts, according to VHA officials. For example, officials shared that the program informed the development of a tool kit for providers to use to help address veterans’ sleep issues after analyses found that sleep patterns were often altered for veterans prior to their death by suicide. Lithium for Suicidal Behaviors in Mood Disorders study. As of March 2019, VHA is in the process of conducting a randomized clinical trial that examines the effect of a specific psychotropic medication (lithium) on reducing suicide risk for veterans with MDD or bipolar disorder who either survived a recent suicide attempt or were hospitalized to prevent one. VHA plans to enroll 1,600 veterans in the study from 28 VAMCs and provide them with the appropriate treatment options as determined by their respective providers, as well as provide some additional care coordination. Additionally, half of the participants will receive lithium, and half of the participants will receive a placebo. The study’s investigators told us that, to their knowledge, this study is the first effort to test lithium’s efficacy for reducing suicide risk in a randomized clinical trial setting. Investigators also told us that, because all participants will receive medications already proven safe and effective for the treatment of their conditions, it is not considered unethical to withhold lithium, a yet untested medication for treating suicide risk, from half of participants. VHA investigators told us they hope to use the results of this clinical trial to inform future treatment options for patients with MDD or bipolar disorder and who are at risk of suicide. Drugs and Suicide Risk study. Between January 2017 and October 2018, VHA officials and collaborators at the University of Chicago and Columbia University analyzed 513 medications, which included psychotropic medications, prescribed between 2003 and 2014 for association with increased or decreased risk of suicidal events in VHA patients. According to the study’s investigators, they expect to be able to identify specific psychotropic medications that are found to be associated with the largest increases and decreases in suicide risk. VHA officials told us that as of March 2019, the research manuscript was under review for publication in a peer-reviewed journal. Using Big Data and Precision Medicine to Assess and Manage Suicide Risk in U.S. Veterans study. As of March 2019, VHA officials, in collaboration with the Department of Energy, were in the process of developing a new model to predict suicidal behavior among veterans by combining data on genetic and non-genetic risk factors, such as demographics, medical conditions, and stressful life events; psychotropic medications are also included as a risk factor, according to VHA officials. The researchers are expected to combine data from VHA electronic medical records with data from a VHA Office of Research and Development program that collects genetic information from veterans to develop the new algorithm. VHA officials we interviewed noted some broad challenges not exclusive to VHA that may affect efforts for any researcher in examining suicide risk and the use of psychotropic medications: Multiple risk factors. All VHA officials that we spoke with discussed the need for efforts examining psychotropic medications and suicide risk to account for other suicide risk factors beyond the use of these types of medication. Such factors may include having a substance use disorder or other mental health diagnoses; homelessness; chronic (non-mental health) medical conditions; age; and psychosocial factors, such as recent loss of a significant other or a history of abuse or violence. Methodological considerations. Most VHA officials that we spoke with mentioned some methodological considerations that must be considered when designing a research study to examine this relationship. For example, an official told us that measuring veterans’ medication adherence is important to track, but is difficult to do as VHA generally only has data on whether medications were dispensed to veterans, not whether medications were actually taken. Ethics. Some VHA officials that we spoke with noted that certain ethical considerations may limit the methodological options available to researchers, such as randomized clinical trials. For example, it would be unethical to withhold medications that have been proven as safe and effective from veterans who may clinically benefit from receiving such treatments, such as from veterans in a control group. In the face of these challenges, VHA officials also noted some advantages VHA researchers, in particular, may experience in examining the use of psychotropic medications and suicide risk: a large patient population with more than 2 million veterans who have at least one mental health condition, and a corresponding electronic medical records database, providing sufficient data and sample sizes needed to test hypotheses; internal funding streams dedicated to research activities examining issues related to suicide prevention, such as funds available through three of VA’s Office of Research and Development’s four central research services; and research centers with researchers who have specific expertise about issues related to suicide prevention and the treatment of serious mental health conditions. Veterans diagnosed with mental health conditions rely on providers in VAMCs across the country to make treatment decisions that are safe and effective, including whether to treat highly prevalent and serious conditions such as MDD and PTSD with psychotropic medications, non- pharmacologic therapy, or a combination of both. In recent years, VHA has taken steps aimed at improving the safety and effectiveness of prescribing decisions for certain psychotropic medications and noted important improvements resulting from these efforts. However, VHA’s oversight related to treatment planning needs improvement. VHA has yet to disseminate guidance that clearly reflects its expectation that mental health providers in specialty care document mental health treatment plans in a readily identifiable manner in veterans’ medical records. Additionally, VHA does not monitor whether mental health providers are considering evidence-based treatment options in treatment plans, as VHA requires in its mental health services handbook. As a result, VHA cannot ensure that providers are considering and documenting all appropriate treatment options, adequately evaluating patient care, and making treatment modifications as necessary, among other issues. Furthermore, the lack of monitoring may impede VHA’s ability to identify important factors that contribute to providers’ treatment decisions, which could in turn allow VHA to identify more systemic barriers to safe and effective treatment, such as needed training. In addition, being able to readily identify how veterans are being treated for mental health conditions may allow VHA to enhance its research efforts related to suicide risk. VHA has noted several advantages it has in conducting research involving the role of psychotropic medications in suicide risk among veterans, including that VHA researchers have access to a large patient population with at least one mental health condition. Monitoring veterans’ use of psychotropic medications and non- pharmacologic therapies and related outcomes may further enhance this capacity for research on suicide risk. We are making the following two recommendations to VA: The Veterans Health Administration should disseminate guidance for VISNs and VAMCs that more clearly reflects its expectation that mental health providers in specialty care should record mental health treatment plans within veterans’ medical records in an easily identifiable way. (Recommendation 1) The Veterans Health Administration should develop and implement an approach for monitoring treatment plans for veterans with mental health conditions to ensure that such plans include documentation that different evidence-based treatment options were considered. (Recommendation 2) We provided a draft of this report to VA for review and comment. In its written comments, which are reproduced in Appendix IV, VA concurred with our recommendations. VA agreed that the recommendations would promote adherence to mental health treatment planning requirements. VA stated that it is developing guidance to help ensure that mental health providers in specialty care record mental health treatment plans in separate, easily identifiable documents within veterans’ medical records. VA also stated that it will develop and implement a process for monitoring whether such plans include documentation that providers considered different evidence-based treatment options. We will monitor VA’s efforts to address our recommendations. As agreed with your office, 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 to the appropriate congressional committee and the Secretary of Veterans Affairs. In addition, the report will be available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-7114 or at DraperD@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix V. We reviewed a nongeneralizable, randomly selected sample of 75 veterans’ medical records from five Department of Veterans Affairs (VA) medical centers (VAMC)—25 for each of the three most prevalent conditions diagnosed among veterans—who had at least one primary care visit in fiscal year 2017 and were prescribed a new psychotropic medication. About half (37) of the 75 medical records we reviewed indicated the veteran was prescribed a new psychotropic medication prior to or without being referred to a mental health provider in specialty care. See table 4. We reviewed a separate, nongeneralizable, randomly selected sample of an additional 75 veterans’ medical records from the five VAMCs—25 for each of the three most prevalent conditions diagnosed among veterans— who were newly diagnosed within that year. Over half (44) of the 75 medical records we reviewed indicated whether the veteran was offered non-pharmacologic therapy in lieu of or in addition to being prescribed a psychotropic medication. See table 5. We analyzed national data obtained from VHA on the types of treatments received by veterans with a diagnosis of a single mental health condition who had encounters with VHA providers for that diagnosis in fiscal year 2018, including the three most prevalent mental health conditions diagnosed among veterans. See Figure 5 for the percentages of veterans with these three conditions or another mental health condition who received (1) non-pharmacologic therapy (psychotherapy), (2) at least one medication from a psychotropic medication class, (3) a combination of the two, or (4) neither psychotropic medication nor non-pharmacologic therapy in fiscal year 2018. We also analyzed national encounter data obtained from VHA for veterans with one of the three most prevalent mental health conditions and who received psychotropic medications in a VA medical center (VAMC) in fiscal year 2018. We found that for all three conditions, the largest percentage of veterans who received at least one psychotropic medication from one class were seen in the primary care setting only. The percentages of veterans with medications from two or three classes— typically veterans who had more complex mental health conditions, according to a VHA official—were larger for veterans seen by specialty care providers, compared to the percentages of veterans with medications from multiple classes seen in primary care only. See Figure 6. The Veterans Health Administration (VHA) has taken steps to improve the safe and effective prescribing of certain psychotropic medications used to treat veterans with mental health conditions through the Psychotropic Drug Safety Initiative (PDSI). PDSI has consisted of three phases since 2013, when the initiative began. Each phase has focused on making improvements related to the prescribing of different classes or types of psychotropic medications, or treating different age groups or mental health conditions and substance use disorders. PDSI is currently in phase 3, and VHA is in the process of planning for phase 4. According to a VHA official, PDSI phase 4 (expected to begin in July 2019) will, in part, increase the role of mental health providers in the monitoring and management of the co-prescribing of benzodiazepines (a type of antianxiety medication) and opioids. This includes tapering the use of these medications among this high-risk veteran population to a reduced dose or discontinuation entirely when the harms associated with their concurrent use outweigh the benefits. The same official told us that, to date, VHA has primarily focused on monitoring the concurrent use of these medications—which the Department of Veterans Affairs’ and the Department of Defense’s clinical practice guideline (CPG) for opioid therapy strongly recommends against—through the Opioid Safety Initiative and in the primary care setting (see text box). Veterans Health Administration’s (VHA) Efforts to Taper Veterans Co-Prescribed Benzodiazepines and Opioids Efforts focused on the establishment of safe and effective tapering programs in the primary care setting: VHA launched the Opioid Safety Initiative in 2013 to ensure that veterans are prescribed and use opioid pain medications in a safe and effective manner. This initiative seeks to establish safe and effective tapering programs for veterans who are co-prescribed opioids and benzodiazepines, among other goals. A VHA official told us that the initiative primarily focuses on monitoring and managing the concurrent use of these medications in the primary care setting. Efforts conducted on an individualized, gradual basis: The Department of Veterans Affairs’ and Department of Defense’s clinical practice guideline (CPG) for opioid therapy strongly recommends that tapering of opioids be done on an individualized basis, weighing the benefits and risks to each veteran as well as the veteran’s characteristics and needs. The CPG also notes that the sudden stopping of benzodiazepines should be avoided, since doing so can lead to seizures or death. Department of Veterans Affairs and Department of Defense, Clinical Practice Guideline for Opioid Therapy. To help achieve PDSI’s goal of improving the prescribing of certain psychotropic medications, VHA officials leading PDSI collaborate with VHA’s Academic Detailing program. Academic detailers, who are Veterans Integrated Service Networks (VISN) or Department of Veterans Affairs (VA) medical center (VAMC) clinical pharmacy specialists, disseminate resources and provide one-on-one educational outreach to providers to help them improve their psychotropic medication prescribing practices. Pharmacy staff, including staff involved in academic detailing, from four VISNs told us that they provide education related to PDSI. The Academic Detailing program has also implemented a campaign to improve the appropriate prescribing and monitoring of stimulants (see text box). Veterans Health Administration’s (VHA) Academic Detailing Program Prescription Stimulants Campaign According to a VHA official, in February 2018, the Academic Detailing program implemented a campaign to improve the treatment of patients receiving prescription stimulant therapy for adult attention-deficit / hyperactivity disorder. A VHA official told us that Veterans Integrated Service Networks (VISNs) or Department of Veterans Affairs (VA) medical centers (VAMCs) may choose, but are not required, to participate in this campaign. The stimulant campaign dashboard includes VAMC scores on 13 quality indicators related to (1) prescribing stimulants for off-label use, (2) assessing co-morbidities, (3) monitoring patients, and (4) managing medication. For example One quality indicator measures the percentage of veterans co-prescribed a stimulant and a benzodiazepine, and Another quality indicator measures the percentage of veterans co-prescribed a stimulant and an opioid. Academic detailers (VISN or VAMC clinical pharmacy specialists) may use the dashboard to identify providers who may benefit from changes to their stimulant prescribing practices. A VHA official reported that between February 2018 and the end of fiscal year 2018, academic detailers made 37 staff interactions with providers related to the national academic detailing program’s stimulant campaign. As of October 2018 (the most recent data available), 37,223 veterans with at least one diagnosed mental health condition had an active prescription for at least one stimulant, according to a VHA official. Among these veterans, 2,360 had a co-occurring cardiac condition.Sudden death, stroke, or other cardiac events have been reported with stimulants. The U.S. Food and Drug Administration has stated that stimulants should generally not be used in patients with serious heart problems or for whom an increase in blood pressure or heart rate would be problematic. See U.S. Food and Drug Administration, FDA Drug Safety Review Communication: Safety Review Update of Medications Used to Treat Attention-Deficit / Hyperactivity Disorder (ADHD) in Adults, accessed March 1, 2019, https://www.fda.gov/Drugs/DrugSafety/ucm279858.htm. In addition to the contact named above, Hernán Bozzolo (Assistant Director), Kaitlin Asaly (Analyst-in-Charge), Jennie F. Apter, Karen Belli, Topher Hoffmann, and Rebecca Rust Williamson made key contributions to this report. Also contributing were Rich Lipinski, Diona Martyn, Vikki Porter, and Jennifer Whitworth.
In fiscal year 2018, of the roughly 6 million veterans who received services from VHA, approximately 2 million had a diagnosis for at least one mental health condition. Treatments for such mental health conditions can include psychotropic medications or non-pharmacologic therapies, which can be prescribed or offered by VA providers in outpatient settings including primary and specialty care. GAO was asked to review how mental health treatment decisions are made by providers in VAMCs and monitored by VHA. This report examines, among other things, (1) factors that contribute to providers' treatment decisions for veterans with mental health conditions, (2) VHA's guidance for documenting mental health treatment plans, (3) VHA's monitoring of whether providers document their consideration of different treatment options, and (4) VHA's efforts to improve the treatment of veterans prescribed psychotropic medications. GAO reviewed VHA documents and a nongeneralizable sample of veterans' medical records from five VAMCs (selected for variety in facility complexity and location); analyzed data on psychotropic medication prescribing; and interviewed VHA and VAMC officials. Officials from the five selected Department of Veterans Affairs (VA) medical centers (VAMC) GAO spoke with reported various factors that contribute to providers' mental health treatment decisions, including decisions regarding the prescribing of psychotropic medications and the offering of non-pharmacologic therapy. Examples of reported factors include: VAMC resources, such as the availability of appointments with mental health providers in specialty care, and the complexity of veterans' mental health conditions, such as the veterans' diagnoses and treatment history. Officials with VA's Veterans Health Administration (VHA) told GAO that specialty mental health care providers are expected to document mental health treatment plans in an easily identifiable way in veterans' medical records, but VHA has not developed guidance explicitly addressing this expectation. For example, VHA's mental health services handbook requires that treatment plans include certain components, but does not specify where to document the plan within a veteran's medical record. As a result, there is a risk that a provider may be unable to readily access information about a veteran's mental health treatment, including the use of medication or therapy, during changes in a veteran's care. VHA has not monitored whether mental health providers in specialty care document the required consideration of different treatment options—such as psychotropic medications or non-pharmacologic therapy—within mental health treatment plans. VHA officials told GAO that VHA relies on the Joint Commission (an independent, not-for-profit organization that accredits and certifies health care organizations) to assess specialty mental health treatment plans as part of the organization's accreditation process for each VAMC. However, the Joint Commission's standards do not specifically assess whether providers consider different treatment options. As a result, VHA cannot ensure that providers are considering all available treatment options and providing the most appropriate treatments to each veteran. VHA has taken steps to improve veterans' mental health treatment through the Psychotropic Drug Safety Initiative (PDSI)—an initiative focused on the safe and effective prescribing of certain psychotropic medications. For example, the first phase included a performance metric aimed at decreasing the percentage of veterans with post-traumatic stress disorder receiving one or more outpatient prescriptions for a benzodiazepine (a medication used to treat anxiety) because of risks associated with the medication. VHA reported a nationwide 5.4 percentage point decrease in the prescribing of this medication for these patients, as well as improvements in the majority of the initiative's other performance metrics. VHA should (1) disseminate guidance reflecting its expectation that providers document mental health treatment plans in an easily identifiable way, and (2) implement an approach for monitoring whether these treatment plans include consideration of treatment options. VHA agreed with GAO's recommendations.