Semiannual Report to Congress: October 1, 2020 through March 31, 2021

This report was submitted to the Comptroller General in accordance with Section 5 of the Government Accountability Office Act of 2008. The report summarizes the activities of the Office of Inspector General (OIG) for the six-month reporting period ending March 31, 2021. During the reporting period, the OIG issued one audit report and began three performance audits. In addition, the OIG closed four investigations and two self-initiated inquiries, and opened seven new investigations. The OIG processed 46 hotline complaints, many of which were referred to other OIGs for action because the matters involved were within their jurisdictions.

The OIG remained active in the GAO and OIG communities by briefing new GAO employees on its audit and investigative missions, and participating in committees and working groups of the Council of Inspectors General on Integrity and Efficiency, including those related to the Pandemic Response Accountability Committee. Details of these activities and other accomplishments are provided in the report.

For more information, contact Tonya R. Ford at (202) 512-5748 or oig@gao.gov.

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  • Opioid Use Disorder: Treatment with Injectable and Implantable Buprenorphine
    In U.S GAO News
    Of the medications used to treat opioid use disorder (OUD), only buprenorphine is both a controlled substance and available as an injection or implant. Buprenorphine is used to treat patients with OUD because it reduces or eliminates opioid withdrawal symptoms and blunts the euphoria or dangerous side effects of other opioids, such as heroin. When used to treat OUD, buprenorphine, in any form, is subject to additional laws and regulations that are overseen by the Drug Enforcement Administration (DEA), within the Department of Justice (DOJ) and the Substance Abuse and Mental Health Services Administration (SAMHSA), within the Department of Health and Human Services (HHS). To ensure patient safety when injectable and implantable buprenorphine is used, the Food and Drug Administration (FDA), within HHS has also required drug companies to establish risk evaluation and mitigation strategies to help ensure the benefits of these medications outweigh their risks. Providers and pharmacies must follow a number of specific steps based on federal requirements when providing treatment with injectable and implantable buprenorphine. Providers are responsible for prescribing, storing, and administering injectable and implantable buprenorphine, while pharmacies are responsible for dispensing these medications (see figure). Representatives GAO interviewed from provider groups and pharmacies said they did not find the steps involved in treating patients to be difficult overall. However, they stated that careful and timely coordination with each other and patients is needed at key steps of the process to ensure that the patient receives treatment. Representatives from provider groups and pharmacies reported that the risk of diversion of injectable and implantable buprenorphine is low. For example, all of the provider groups GAO spoke with said that diversion of injectable or implantable buprenorphine is unlikely, and representatives from three of the six provider groups said that the design of these formulations reduces opportunities for diversion due to how they are administered. Process for Treating Opioid Use Disorder with Injectable and Implantable Buprenorphine The use of injectable and implantable buprenorphine to treat OUD is relatively low compared to oral forms of buprenorphine. HHS has reported that about 7,250 prescriptions were issued for injectable and implantable buprenorphine in fiscal year 2019, compared to over 700,000 patients who received buprenorphine prescriptions for oral formulations to treat OUD or pain in that year. In 2018, SAMHSA estimated that about one-quarter of the estimated 2 million people with OUD had received some form of substance use treatment in the prior year. One form of treatment—medication-assisted treatment (MAT)— combines behavioral therapy with the use of certain medications. HHS has identified expanding access to treatment for OUD as an important strategy for reducing opioid morbidity and mortality, which includes increasing the number of injectable and implantable buprenorphine prescriptions. Congress included a provision in the SUPPORT Act for GAO to review access to and the potential for the diversion of controlled substances administered by injection or implantation. This report focuses on injectable and implantable controlled substances that can be used to treat OUD and specifically, describes the process for treating OUD with injectable and implantable buprenorphine and what is known about their use. GAO reviewed laws, regulations, and documentation from DEA, FDA, and SAMHSA governing the process of providing treatment with buprenorphine and interviewed officials from those agencies. GAO also interviewed representatives from stakeholder groups representing MAT providers; drug companies that manufacture injectable or implantable buprenorphine; and pharmacies that dispense these medications. HHS and DOJ reviewed a draft of this report, and GAO incorporated their technical comments, as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
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  • TSA Acquisitions: TSA Needs to Establish Metrics and Evaluate Third Party Testing Outcomes for Screening Technologies
    In U.S GAO News
    In 2013, the Transportation Security Administration (TSA) introduced the concept of third party testing—having an independent testing entity verify that a security screening system meets certain requirements. The concept is that screening system vendors would take this additional step either prior to submitting their technologies to TSA or if their system failed TSA's test and evaluation process. The goal is for third party testing to reduce the time and resources that TSA spends on its own testing. However, since introduced, TSA has directed only three vendors that failed TSA tests to use third party testing, with varying outcomes. In two other cases, TSA supplemented its test capabilities by using third party testers to determine that systems installed at airports were working properly. TSA officials and industry representatives pointed to several reasons for third party testing's limited use since 2013, such as the cost to industry to use third party testers and TSA's reluctance to date to accept third party test data as an alternative to its own. Despite this, TSA officials told GAO they hope to use third party testing more in the future. For example, in recent announcements to evaluate and qualify new screening systems, TSA stated that it will require a system that fails TSA testing to go to a third party tester to address the identified issues (see figure). Example of Use of Third Party Testing When a System Experiences a Failure in TSA's Testing TSA set a goal in 2013 to increase screening technology testing efficiency. In addition, TSA reported to Congress in January 2020 that third party testing is a part of its efforts to increase supplier diversity and innovation. However, TSA has not established metrics to determine third party testing's contribution toward the goal of increasing efficiency. Further, GAO found no link between third party testing and supplier diversity and innovation. Some TSA officials and industry representatives also questioned third party testing's relevance to these efforts. Without metrics to measure and assess the extent to which third party testing increases testing efficiency, TSA will be unable to determine the value of this concept. Similarly, without assessing whether third party testing contributes to supplier diversity and innovation, TSA cannot know if third party testing activities are contributing to these goals as planned. TSA relies on technologies like imaging systems and explosives detection systems to screen passengers and baggage to prevent prohibited items from getting on board commercial aircraft. As part of its process of acquiring these systems and deploying them to airports, TSA tests the systems to ensure they meet requirements. The 2018 TSA Modernization Act contained a provision for GAO to review the third party testing program. GAO assessed the extent to which TSA (1) used third party testing, and (2) articulated its goals and developed metrics to measure the effects of third party testing. GAO reviewed TSA's strategic plans, acquisition guidance, program documentation, and testing policies. GAO interviewed officials from TSA's Test and Evaluation Division and acquisition programs, as well as representatives of vendors producing security screening systems and companies providing third party testing services. GAO is recommending that TSA develop metrics to measure the effects of third party testing on efficiency, assess its effects on efficiency, and assess whether third party testing contributes to supplier diversity and innovation. DHS concurred with GAO's three recommendations and has actions planned to address them. For more information, contact Marie A. Mak at (202) 512-4841 or MakM@gao.gov.
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