Recommendation: The DEA Administrator should develop and implement additional ways to use algorithms in analyzing ARCOS and other data to more proactively identify problematic drug transaction patterns. (Recommendation 1)

Agency: Department of Justice: Drug Enforcement Administration
Status: Open
Priority recommendation

Comments: DOJ agreed with this recommendation and DEA stated it will continue to examine a variety of technologies to analyze ARCOS and other data and implement additional ways to use algorithms to more proactively identify problematic drug transaction patterns.

Recommendation: The DEA Administrator, in coordination with the department-wide efforts on data strategy, should establish and document a data governance structure to ensure DEA is maximizing its management of industry-reported drug transaction data. (Recommendation 2)

Agency: Department of Justice: Drug Enforcement Administration
Status: Open
Priority recommendation

Comments: DOJ agreed with this recommendation. As of September 2019, DEA officials stated that its Office of Information Systems' Chief Data Officer just recently started to work with DOJ and other components to develop a data strategy in response to the recently released department wide strategy, and has begun efforts to develop a governance structure. In November, 2019 DEA indicated it will continue to mature its data governance structure. The intent of this recommendation is for DEA to establish a formalized data governance structure to manage its collection and use of data used to support the Diversion Control Division's mission.

Recommendation: The DEA Administrator should establish outcome-oriented goals and associated measurable performance targets related to opioid diversion activities, using data it collects, to assess how the data it obtains and uses supports its diversion control activities. (Recommendation 3)

Agency: Department of Justice: Drug Enforcement Administration
Status: Open
Priority recommendation

Comments: DOJ neither agreed nor disagreed with this recommendation but DEA stated in November 2019, that it recognizes that measurable performance targets related to opioid diversion activities can serve as leading practices at different organizational levels including the program, project, or activity level. Our recommendation is intended to ensure that DEA can demonstrate the usefulness of the data it collects and uses to support its opioid diversion control activities.

Recommendation: The DEA Administrator, in consultation with industry stakeholders, should identify solutions to address the limitations of the ARCOS Enhanced Lookup Buyer Statistic Tool, to ensure registrants have the most useful information possible to assist them in identifying and reporting suspicious orders to DEA. (Recommendation 4)

Agency: Department of Justice: Drug Enforcement Administration
Status: Open
Priority recommendation

Comments: DOJ agreed with this recommendation and in November 2019, stated it has consulted with industry stakeholders and identified solutions to address the limitations of the tool.

Recommendation: The Administrator of CMS should determine the extent to which state Medicaid programs are in compliance with federal requirements to cover MAT medications in all formats and take actions to ensure compliance, as appropriate. (Recommendation 1)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Secretary of the VA should direct the Undersecretary for Health to designate a focal point for overseeing VAMCs' pharmacy inventory management system-wide and define the focal point's responsibilities. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA officials provided documentation showing approval as of September 2019 for the procurement of a perpetual inventory management system that would allow VA medical facilities to keep track of inventory for all prescription drugs and assist VA with system-wide oversight. As of January 2020, this contract has yet to be awarded. In January 2020, VA officials also stated that Pharmacy Benefits Management (PBM) Services has been designated as the focal point for overseeing VA medical facilities' inventory management system-wide. VA officials stated that PBM is responsible for developing VA medical facility inventory management policy; however, VA did not provide documentation on PBM's defined responsibilities for system-wide oversight in the absence of an inventory system and once the system is procured. We plan to keep this recommendation open until we receive documentation of PBM's defined responsibilities for overseeing VAMC's pharmacy inventory management system-wide.

Recommendation: The Undersecretary for Health should ensure that Central Office, Veterans Integrated Service Networks (VISN), and medical facilities document the actions they take towards achieving OSI goals. (Recommendation 1)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with the recommendation. To fully implement this recommendation, VHA needs to provide information about the new documentation requirements described in the November 2019 update.

Recommendation: The Undersecretary for Health should ensure that any OSI goals that have not been met have clearly defined, measurable outcomes, including milestones or numerical targets, as appropriate, and timeframes. (Recommendation 2)

Agency: Department of Veterans Affairs
Status: Open

Comments: VA concurred with the recommendation. To fully implement this recommendation, VHA needs to provide information about specific actions, described in the November 2019 update, taken to address the recommendation including documentation showing the actions taken to review the OSI goals and documentation of new OSI goals, metrics, and timelines.

Recommendation: The Director of ONDCP, in collaboration with law enforcement and public health counterparts, should lead a review on ways to improve the timeliness, accuracy, and accessibility of fatal and non-fatal overdose data from law enforcement and public health sources that provide critical information to understand and respond to the opioid epidemic. Such a review should expand on and leverage the findings from previous federal studies. It should also assess the benefits and scalability of ongoing efforts to leverage data systems, such as the Washington-Baltimore High-Intensity Drug Trafficking Areas' (HIDTA) OD MAP program, and examine ways in which laws that restrict access to public health data to protect patient privacy have exemptions for law enforcement entities that could be more widely leveraged while protecting patient privacy. (Recommendation 2)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials noted a number of federal initiatives underway to evaluate the timeliness, accuracy, and accessibility of overdose data. For example, ONDCP discussed its participation in a new Interagency Working Group led by the National Security Council to consider the implementation of overdose tracking and analytic capability, such as the expansion of ODMAP, as well as evaluating the appropriate federal role to engage in this initiative. In March 2019, ONDCP reported that it had suspended its ODMAP working group in the summer of 2018, after determining that this effort would be more effective for the Department of Justice's Bureau of Justice Assistance (BJA) and the Centers for Disease Control and Prevention (CDC) to work together through the Comprehensive Opioid Abuse Program Initiative. Nevertheless, as of April 2019, ONDCP officials reported that they continue to provide grant funding and training and technical assistance towards the expansion and use of ODMAP by state and local jurisdictions. Further, ONDCP reported supporting other federal data initiatives, such as providing funding to develop software for the CDC's National Center for Health Statistics Mortality Data that could better read narrative fields in death certificates to improve the timeliness and accuracy of the data. While ONDCP's efforts are directed towards supporting and improving existing data sources, the recommendation asks ONDCP to lead a review which it has not done. Further, ONDCP's initiatives to date have not addressed issues raised in our report related to balancing law enforcement's access to restricted health data while protecting patient privacy. We will continue to monitor ONDCP's efforts towards implementing this recommendation.

Recommendation: The Director of ONDCP should work with the HIDTAs participating in the Heroin Response Strategy to establish outcome-oriented performance measures for the four main goals set out in the strategy. (Recommendation 3)

Agency: Executive Office of the President: Office of National Drug Control Policy
Status: Open

Comments: In the 60-day letter, dated June 28, 2018, ONDCP officials stated that they had engaged with leaders from HIDTA participating in the Heroin Response Strategy to develop performance measures. According to ONDCP, as of early May 2018, eleven performance measures had been established--nine mandatory measures and two optional measures--and four of these measures constitute outcome-oriented measures. The June letter also noted that the HIDTA Performance Management Process database was being updated to reflect the new measures and ONDCP expected the system to be fully operational by the end of September 2018. In March 2019, ONDCP reported that, throughout the summer of 2018, it had revisited the performance measures it had developed and settled on ten revised performance measures (eight mandatory measures and two optional measures) for the newly branded Opioid Response Strategy (formerly known as the Heroin Response Strategy). According to ONDCP, these measures were implemented in HIDTA's Performance Management Process as of February 1, 2019. We will continue to coordinate with ONDCP to obtain documentation of these new measures. Once we obtain them, we will review and work toward closing the recommendation, as appropriate.

Recommendation: The Executive Director of Organized Crime Drug Enforcement Task Forces should work with the National Heroin Initiative Coordinator to establish outcome-oriented performance measures for the goals set out for National Heroin Initiative. (Recommendation 4)

Agency: Department of Justice: Organized Crime Drug Enforcement Task Forces
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, officials from the Organized Crime Drug Enforcement Task Force (OCDETF) noted the output metrics and statistics that OCDETF is tracking as part of its National Heroin Initiative. For example, the letter states that OCDETF will track statistics on opioid overdose deaths, however it is unclear how this tracking effort is being incorporated into the National Heroin Initiative. While our report noted that statistics on overdose deaths have been used as outcome-oriented measures by agencies like the Office of National Drug Control Policy to assess its efforts, it is unclear how OCDETF is using these statistics to assess its performance and inform its efforts under the National Heroin Initiative. In October 2018, OCDETFs National Heroin Initiative Coordinator told us that the OCDETF Regional Directors were in the process of establishing and tracking region-specific metrics, such as local data on drug overdoses. In January 2020, we reached out to OCEDTF officials for an update, and they did not have any further information to provide. In August 2020, OCDETF officials told us that the National Heroin Initiative had evolved and they are no longer positioned to collect and report on drug overdoses as a performance measure for the initiative. However, officials stated that the initiative is measuring the number of OCDETF cases that are produced that result in the disruption or dismantlement of criminal networks involved in heroin and opioid trafficking. We asked OCDETF to provide documentation of the current state of the initiative and its related goals and performance measures. Once received, we will review and follow-up with OCDETF, if needed, to work towards the closure of the recommendation as implemented.

Recommendation: The Attorney General should, in consultation with its relevant components such as the Drug Enforcement Administration (DEA) and Executive Office for United States Attorneys (EOUSA), establish goals and outcome oriented performance measures for its Strategy to Combat the Opioid Epidemic. (Recommendation 5)

Agency: Department of Justice
Status: Open
Priority recommendation

Comments: In its 60 Day-letter, dated June 26, 2018, DOJ officials reported a number of output measures, such as conviction rates, that they will use to assess the effectiveness of the department's efforts to respond to the opioid epidemic. However, it is unclear how, if all, these measures have been incorporated into the department-wide strategy or if additional outcome-oriented metrics are being developed. In October 2018, DOJ officials reported that while they have not updated the strategy, then-Attorney General Sessions had issued a memo to the U.S. Attorneys that communicated some goals for their efforts, such as reductions in overdose deaths, and called for the U.S. Attorneys Office's Regional Opioid Coordinators to develop metrics specific to their regions. In October 2019, DOJ officials reported that the department is currently working on finalizing its Annual Priority Goals and related performance measures with respect to opioids, however they could not provide additional details nor a timeline for when these efforts are to be completed. We reached out in January 2020 to receive additional details and the Department did not have any further information to provide. We will continue to coordinate with DOJ to learn more about these efforts and when officials expect them to be implemented.

Recommendation: The DEA Administrator should establish goals and outcome-oriented performance measures for the enforcement and diversion control activities within the 360 Strategy and establish outcome-oriented performance measures for the community engagement activities within the 360 Strategy. (Recommendation 6)

Agency: Department of Justice: Drug Enforcement Administration
Status: Open
Priority recommendation

Comments: In its 60-Day Letter, dated June 26, 2018, DEA officials noted the steps they had taken to develop performance metrics for its enforcement and diversion control activities under the 360 Strategy and reported that DEA had implemented outcome-oriented performance metrics for the 360 Strategy's community engagement activities for fiscal year 2019. Further, DEA officials noted applying DEA's Threat Enforcement Planning Process (TEPP) specifically to the 360 Strategy to develop outcome-oriented metrics. Further, according to DEA officials, the TEPP includes an impact report that assesses the outcomes of the activities undertaken under 360. In October 2018, DEA told us that TEPP was still in development and they did not give a date for projected completion. In January 2020, we reached out to DEA officials for an update, and they did not have any further information to provide. We will continue to follow up with DEA officials on their progress.

Recommendation: The Administrator of CMS should require plan sponsors to report to CMS on investigations and other actions taken related to providers who prescribe high amounts of opioids. (Recommendation 3)

Agency: Department of Health and Human Services: Centers for Medicare and Medicaid Services
Status: Open

Comments: HHS did not concur with this recommendation. As of September 2019, HHS had not provided information on actions taken to implement it. We will update its status when we receive additional information.

Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should develop policies and procedures to validate SSNs and apply the policies and procedures to all new and existing SSNs in the CSA2; such an approach could involve collaborating with SSA to assess the feasibility of checking registrants' SSNs against the Enumeration Verification System.

Agency: Department of Justice: Drug Enforcement Administration
Status: Open

Comments: In April 2018, DEA told us that it assessed the feasibility of directly collaborating with SSA to check registrants' SSNs against any SSA systems, including the Enumeration Verification System (EVS), and is unable to implement a data verification process to validate SSNs against EVS without legislative authority. Specifically, DEA said that access to SSA's systems would require passage of new legislation to authorize DEA to fully participate in a data exchange agreement with SSA, which DEA said was also confirmed by Senate staff. In June 2020, DEA provided documentation of SSA's response to DEA's request to access EVS which stated that SSA was unable to enter into a data exchange under the conditions DEA initially proposed. However, it also stated that SSA would explore granting DEA access if DEA requested number-holder's consent. Therefore, we continue to believe there is a possible path forward in using SSA's service. Additionally, DEA told us that it would use information from the Federation of State Medical Boards (FSMB) to validate SSNs. However, as of August 2020, DEA has not provided any documentation to support how or if this has been implemented. Further, as noted in our report, FSMB is limited to information for medical doctors, osteopathic doctors and some physician assistants, which make up only a portion of DEA's registrants. As we noted in our report, validating SSNs will help establish registrants' identities which will better ensure DEA has the information necessary to implement its existing controls and to identify other registrations held by each individual, including past adverse actions taken against previous registrations. As such, we continue to believe that DEA should take steps to validate the information it receives. We will continue to monitor the agency's progress in this area.

Recommendation: To help ensure that practitioners who may be ineligible do not possess a controlled substance registration and that practitioners who pose an increased risk of illicit diversion are identified, the Acting Administrator of DEA should take additional actions to strengthen verification controls. Specifically, the Acting Administrator of DEA should identify and implement a cost-effective approach to monitor state licensure and disciplinary actions taken against its registrants; such an approach could include using data sources that contain this information, such as the National Practitioner Data Bank or the Federation of State Medical Boards.

Agency: Department of Justice: Drug Enforcement Administration
Status: Open

Comments: In July 2018, DEA provided a copy of its purchase order award to the Federation of State Medical Boards (FSMB); however, as of August 2020, DEA has not provided documentation to demonstrate how use of FSMB will be implemented. Also, in April 2018, DEA said it was exploring how to establish a cost-effective system to obtain National Practitioner Data Bank (NPDB) information and will reevaluate the need to obtain NPDB information after DEA has had the opportunity to process the FSMB information. In June 2020, DEA stated it will not be taking additional action on obtaining NPDB. We will continue to monitor DEA's progress in implementing this recommendation.

Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from distributors, or associations representing distributors, and develop additional guidance for distributors regarding their roles and responsibilities for suspicious orders monitoring and reporting.

Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
Status: Open
Priority recommendation

Comments: In September 2019, DEA told us that the agency had refocused its efforts on revising draft regulations in line with the SUPPORT for Patients and Communities Act, and that the revised draft was undergoing internal DEA and Department of Justice review. The agency noted that it expected the rule to codify existing legal obligations related to due diligence and suspicious order reporting and provide additional guidance regarding the nature and timing of the suspicious order reporting requirement, but also indicated that it was not possible to be certain of the precise nature of the draft rule. While DEA has reported taking some actions to address this recommendation, as noted above, until the regulations are finalized we cannot determine if these changes will fully address the recommendation. We will continue to monitor DEA's progress in addressing our recommendation.

Recommendation: In order to strengthen DEA's communication with and guidance for registrants and associations representing registrants, as well as supporting the Office of Diversion Control's mission of preventing diversion while ensuring an adequate and uninterrupted supply of controlled substances for legitimate medical needs, the Deputy Assistant Administrator for the Office of Diversion Control should solicit input from pharmacists, or associations representing pharmacies and pharmacists, about updates and additions needed to existing guidance for pharmacists, and revise or issue guidance accordingly.

Agency: Department of Justice: Drug Enforcement Administration: Operations Division: Office of Diversion Control: Deputy Assistant Administrator for the Office of Diversion Control
Status: Open

Comments: In April 2016, DEA reported that it had worked with the National Association of Boards of Pharmacy regarding issues raised during stakeholder discussions, which resulted in a March 2015 consensus document published by stakeholders entitled "Stakeholders' Challenges and Red Flag Warning Signs Related to Prescribing and Dispensing Controlled Substances." Additionally, in December 2016 DEA also described other ways in which the agency had been working with pharmacists or associations representing pharmacists to discuss their responsibilities, such as during regional one-day Pharmacy Diversion Awareness Conferences, and quarterly meetings with two pharmacy associations. In February 2018, DEA reported that following input from pharmacists, and representatives of pharmacies and pharmacists, it had revised its existing Pharmacist's Manual. DEA reported in September 2019 that the manual was currently in the final approval process for publication, and that when published, DEA would provide the manual to GAO. Until the updated Pharmacist's Manual is published and we have a chance to review the revisions, we cannot fully assess DEA's actions in this area. Therefore, the recommendation remains open.

Recommendation: To improve the CSA program, the Secretary of Transportation should direct the FMCSA Administrator to revise the SMS methodology to better account for limitations in drawing comparisons of safety performance information across carriers; in doing so, the Secretary of Transportation should direct the FMCSA Administrator to conduct a formal analysis that specifically identifies: (1) limitations in the data used to calculate SMS scores including variability in the carrier population and the quality and quantity of data available for carrier safety performance assessments, and (2) limitations in the resulting SMS scores including their precision, confidence, and reliability for the purposes for which they are used.

Agency: Department of Transportation
Status: Open
Priority recommendation

Comments: FMCSA did not agree with our recommendation, disputing the methodology and conclusions in our report. However, we continue to believe that addressing Safety Measurement System (SMS) methodology limitations has merit and could help the agency better target FMCSA's resources to the carriers that pose the highest risk of crashing. For example, we found FMCSA requires a minimum level of information for a carrier to receive an SMS score; however, this requirement is not strong enough to produce sufficiently reliable scores. As a result, FMCSA identified many carriers as high risk that were not later involved in a crash, potentially causing FMCSA to miss opportunities to intervene with higher risk carriers. To fully implement this recommendation, FMCSA should revise SMS methodology to account for data limitations that limit comparisons so that the FMCSA is better positioned to identify and mitigate carriers that pose the greatest safety risks. FMCSA has recently developed and tested a new methodological approach that could potentially account for the limitations we identified. While FMCSA has not yet committed to deploying the new methodology, they hope to do so some time in 2020.

Recommendation: To improve the CSA program, the Secretary of Transportation should direct the FMCSA Administrator to ensure that any determination of a carrier's fitness to operate properly accounts for limitations we have identified regarding safety performance information.

Agency: Department of Transportation
Status: Open

Comments: The Federal Motor Carrier Safety Administration (FMCSA) agreed with the basic principles that GAO addressed in this area, but disagreed with GAO's characterization of FMCSA's proposed Safety Fitness Determination (SFD) rule. In January 2016, FMCSA issued a notice of proposed rulemaking (NPRM), which proposed a revised methodology for issuance of a safety fitness determination for motor carriers. Specifically, the new methodology would have determined when a motor carrier is not fit to operate commercial motor vehicles in or affecting interstate commerce based on the carrier's on-road safety data; an investigation; or a combination of both. However, in July 2018, in part due to a review of SMS by the National Academies of Science congressionally mandated evaluation of SMS, FMCSA announced that the enhancements previously proposed will not be completed.

Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should establish outcome metrics and identify resources for conducting outcome evaluations for the national education campaigns about prescription drug abuse and safe storage and disposal proposed in the Prescription Drug Abuse Prevention Plan.

Agency: Office of National Drug Control Policy
Status: Open

Comments: We requested an update from ONDCP on the status of its efforts to implement this recommendation. As of August, 2018, we have not received a response. We will update the status of this recommendation when we receive additional information.

Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should develop and implement a plan to evaluate outcomes from the proposed national education campaigns.

Agency: Office of National Drug Control Policy
Status: Open

Comments: We requested an update from ONDCP on the status of its efforts to implement this recommendation. As of August, 2018, we have not received a response. We will update the status of this recommendation when we receive additional information.

Recommendation: In order to ensure that federal efforts to prevent the abuse and misuse of prescription pain relievers are an effective and efficient use of limited government resources, the Director of ONDCP should ensure that federal agencies undertaking similar educational efforts leverage available resources and use coordination mechanisms to share information on the development of their efforts.

Agency: Office of National Drug Control Policy
Status: Open

Comments: We requested an update from ONDCP on the status of its efforts to implement this recommendation. As of August, 2018, we have not received a response. We will update the status of this recommendation when we receive additional information.