Controlled Substances:

DEA Should Take Additional Actions to Reduce Risks in Monitoring the Continued Eligibility of Its Registrants

GAO-16-310: Published: May 26, 2016. Publicly Released: Jun 21, 2016.

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What GAO Found

The Drug Enforcement Administration (DEA) has established controls for determining registrant eligibility to handle and prescribe controlled substances. However, GAO found limitations in DEA's controls to help ensure that individual registrants are and remain eligible and do not present issues that may increase the risk of illicit diversion. GAO's examination of DEA's controlled substances database (CSA2) as of March 2014 (the most-current data available) revealed gaps and other issues pertaining to registrants' identifying information. For example, GAO's analysis identified 40,785 of about 1.4 million individual registrations that were registered using a business tax identification number instead of a Social Security number (SSN). According to DEA officials, DEA does not have legal authority to require SSNs for individuals applying as a business. For individuals registered with an SSN, GAO found 11,740 SSNs that could not be validated by the Social Security Administration (SSA) and 688 SSNs that were registered to multiple names or variations of names, which can be a risk indicator of potential fraud. SSNs are needed to identify and remove deceased registrants as well as identify any past adverse history that may affect registrant eligibility. Given that SSNs are critical to validating identities, implementing DEA's controls, and identifying registrants' past adverse history, obtaining legal authority to require SSNs for all individuals and developing policies and procedures to validate them would help ensure that registrants are and remain eligible.

GAO also found limitations in DEA's processes for verifying continued eligibility of its registrants. Of the approximately 1.4 million individual registrations in CSA2 as of March 2014, GAO found 764 registrants who were potentially ineligible because they were reported deceased by SSA, did not possess state-level controlled substance authority, or were incarcerated for felony offenses related to controlled substances. GAO also found 100 registrants who presented issues that may increase the risk of illicit diversion, such as registrants incarcerated for offenses unrelated to controlled substances, registrants with active or recent warrants, and registrants listed as sex offenders. DEA does not have processes in place to verify its registrants' state licenses or criminal background after initial registration, unless the registrant self-reports or the state notifies DEA of actions taken against its registrants. Developing processes to monitor registrant state licensure and disciplinary actions, such as verifying that registrants maintain appropriate state authority and assessing the cost and feasibility of monitoring registrants' criminal backgrounds, would help ensure that registrants maintain eligibility to handle and prescribe controlled substances and do not present issues that may increase the risk of illicit diversion.

Number of Drug Enforcement Administration Controlled Substance Registrants Who Were Potentially Ineligible or May Increase the Risk of Illicit Diversion, as of March 2014

Indicator

Total number of registrations

Registrants who were potentially ineligible because they were reported deceased, did not possess state-level controlled substance authority, or were incarcerated for felony offenses related to controlled substances

764

Registrants who may increase the risk of illicit diversion because they were incarcerated for other offenses, had active or recent warrants, or were listed as sex offenders

100

Source: GAO analysis of Department of Justice, Social Security Administration, and state licensing board data. | GAO-16-310

Why GAO Did This Study

DEA registers individuals and entities authorized to manufacture, distribute, or dispense controlled substances in accordance with the Controlled Substances Act, which seeks to ensure that only authorized individuals handle controlled substances. States also have a role in the registration process as they determine general licensing requirements for health-care professionals who are permitted to handle or prescribe controlled substances. Controlled substances include prescription pain relievers, such as OxyContin, stimulants, and sedatives.

GAO was asked to review DEA's processes for registering applicants, monitoring the eligibility of registrants, and managing CSA2 data. This report assesses the extent to which DEA's internal controls help ensure that individual registrants are and remain eligible and do not present issues that may increase the risk of illicit diversion, among other objectives. GAO reviewed relevant documents and interviewed DEA and state officials. GAO matched CSA2 data to several databases to identify potentially ineligible registrants.

What GAO Recommends

GAO is making five recommendations to DEA to help ensure practitioners are and remain eligible and that those who pose an increased risk of illicit diversion are identified. DEA stated it appreciated the intent of GAO's recommendations, but raised concerns about its legal authority to take some of the actions. GAO's recommendations include having DEA seek legal authority as needed, and remain valid.

For more information, contact Seto Bagdoyan at (202) 512-6722 or bagdoyans@gao.gov.

Recommendations for Executive Action

  1. Status: Open

    Comments: In August 2016, DEA told us it is exploring the possibility and practicality of implementing policy or rule changes that would require Social Security Numbers (SSN) from all persons applying for a DEA Registration as a practitioner or mid-level practitioner. We will continue to monitor DEA's progress in implementing this recommendation.

    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 a legislative proposal requesting authority to require SSNs for all individuals, regardless of whether they hold an individual or business registration.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  2. Status: Open

    Comments: In August 2016, DEA told us that it had initiated discussions with the Social Security Administration (SSA) to determine the legality and feasibility of using SSA's Enumeration Verification System (EVS) to verify SSNs provided during the registration process. DEA stated that SSA has informed both GAO and DEA that its current legislative authorities do not authorize SSA to provide the information to DEA. As a a result, DEA stated that legislative action will be required to allow DEA additional access to EVS. As stated in our report, the use of EVS is one possible approach to validate SSNs. We will continue to monitor DEA's progress in implementing this recommendation.

    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 Affected: Department of Justice: Drug Enforcement Administration

  3. Status: Open

    Comments: In August 2016, DEA told us that the Social Security Administration (SSA) determined that it cannot provide data from the full death file to DEA under existing law for use in administering the DEA Registration Process. DEA also said that if legislative changes allow DEA full access to SSA's full death file, DEA will work with SSA to ensure implementation of the new legislative authority. We continue to believe that DEA should develop a legislative proposal to request access to SSA's full death file and we will continue to monitor DEA's progress in implementing this recommendation.

    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 a legislative proposal to request access to SSA's full death file.

    Agency Affected: Department of Justice: Drug Enforcement Administration

  4. Status: Open

    Comments: In August 2016, DEA told us that currently, the Controlled Substance Act and its implementing regulations do not specifically give DEA authority to access state medical licensing boards' databases. DEA also said that it met with representatives of the Federation of State Medical Boards (FSMB) to develop a process that will allow DEA to accomplish the objectives GAO articulated in the draft report. Specifically, DEA said that it is exploring use of the FSMB service to verify the existence and status of state licenses to ensure all applicants for registration who are Doctors of Medicine and Doctors of Osteopathy, or Physician Assistants (in the states that provide this data to FSMB), meet the requirements to possess a DEA Registration. To implement the above described actions, DEA stated it will need to enter into an agreement with FSMB to provide this data in a format that allows real-time access to the data and accommodates the large numbers of applicants for DEA Registrations. DEA also said it obtained information from FSMB to begin the agreement process and is currently obtaining information on data elements that can be used to test user account codes to flag records in the FSMB. We will continue to monitor DEA's progress in implementing this recommendation.

    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 Affected: Department of Justice: Drug Enforcement Administration

  5. Status: Open

    Comments: In August 2016, DEA told us they are in the process of determining the feasibility of implementing actions that would permit DEA to comply with the recommendation utilizing the current legal framework and within reasonable cost parameters. DEA also said that the large volume of DEA registrations and the large number of applications received monthly present extensive technical and fiscal challenges with addressing this recommendation. We will continue to monitor DEA's progress in implementing this recommendation.

    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 assess the cost and feasibility of developing procedures for monitoring registrants' criminal backgrounds, such as conducting matches against federal law-enforcement databases, and document decisions about the approach chosen.

    Agency Affected: Department of Justice: Drug Enforcement Administration

 

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