Opioid Awareness: New Requirements for DEA-Registered Clinicians

The Drug Enforcement Administration recently released new requirements for DEA-registered clinicians with Schedules II-V authority.

New requirements for DEA-registered clinicians aim to help guide healthcare professionals in their treatment of opioid use disorders.

Approximately 645,000 Americans have died from opioid-related overdoses since the CDC began tracking the crisis in 1999. Medical professionals recommend opioid agonist treatment (OAT) as the first-line therapy for opioid use disorder (OUD), as OAT reduces the incidence of relapse, increases treatment retention and prevents risk of overdose.  

Strong data supports the use of OAT in withdrawal management of opioids, including heroin and methadone. OAT also aids in support recovery, helping patients maintain abstinence and reduce craving from opioids. Until now, the use of OAT has been restricted to clinicians who had been educated on the appropriate use and were able to prescribe these medications. 

Recommended course: Evidence-Based Guidance on Prescribing Controlled Substances

Barriers to care 

Research demonstrates that racial and ethnic minorities are less likely to received OAT for OUD than non-Hispanic White patients. This is in part due to the perception of racial disparity among those patients’ receiving treatment, as well as increased awareness of systemic racism.  

Barriers to access to these therapies are especially notable in correctional facilities. System formularies, lack of practice guidelines, and extensive waitlists for therapy are common. DEA-registered clinicians treating this population of patients must be aware that these racial disparities exist and work to ensure that every patient has access to these life-saving therapies. 

Opioid pharmacotherapy and OUD treatments 

Opioid pharmacotherapy is the practice of replacing a drug of dependence with a prescribed drug under a strict plan with close monitoring. Studies demonstrate that, despite detoxification from opioids, the risk of relapse is high and can lead to a fatal overdose.  

Buprenorphine is used to help treat severe pain from withdrawal, assist with withdrawal from opioids, and reduces the need to use heroin (also called buprenorphine maintenance). A partial opioid agonist that binds to opioid receptor sites, buprenorphine is similar in efficacy to methadone for the treatment of OUD. It is available in an oral tablet, sublingual film, and a subdermal implant. A monthly injection of buprenorphine is also available.  

Though this medication has been available for over 20 years, legislation passed in 2023 has allowed more DEA-registered clinicians to prescribe this medication to their patients. Buprenorphine with naloxone (Suboxone or Zubsolv), a medication used for opioid dependence and maintenance therapy, also has generic equivalents that are available in a sublingual form. 

Additional opioid antagonists 

Other classes of opioid antagonists include naltrexone, which works by blocking activation of opioid receptor sites, thus eliminating the euphoria that comes with opioid use. Clinicians also use naltrexone to treat alcohol use disorder. However, poor tolerability and failure to adhere to the treatment plan by patients often limits naltrexone’s effectiveness.  

An alternative to naltrexone is Vivitrol®. FDA approved for treating OUD, this drug offers a long-acting effect for several weeks. Methadone, a medication that clinicians have used to eliminate withdrawal and cravings, is a synthetic opioid agonist. It works by decreasing pain associated with opioid withdrawal without producing euphoria. It is dispensed only through regulated opioid treatment programs.   

New requirements for DEA-registered clinicians

Earlier in 2023, the Drug Enforcement Administration (DEA) released new requirements for DEA-registered clinicians with Schedules II-V authority (based on individual state requirements). These requirements also cover those who are applying for a DEA number for the first time.  

This one-time continuing education requirement consists of an 8-hour training course focused on prevention of substance use disorder. This mandatory training can be completed asynchronously through in-person, virtual, or professional society meetings.  

Find 8-hour courses in your state 

All courses must include all FDA-approved medication therapies including alcohol, nicotine, and opioid use disorders. Any clinician who has a current DEA registration that includes Schedule III drugs can prescribe buprenorphine to patients who need this therapy for OUD. 

X-waiver and DEA CME requirements 

Before the Mainstreaming Addiction Treatment Act (MAT), the Drug Addiction Treatment Act (DATA 2000) created legislation for the DATA or “X” waiver, aptly named for the “X” designation after one’s name on the DEA registration. This designation was for any prescriber who had completed an X-waiver training on buprenorphine.  

X-waivers were created for those clinicians who had undergone extensive training that authorized the outpatient use of buprenorphine for the treatment of OUD. However, in 2023, Section 1262 of the Consolidated Appropriations Act removed the outdated waiver requirements and the Notice of Intent for clinicians to prescribe buprenorphine. This allowed clinicians with a current DEA registration to prescribe buprenorphine for OUD if permitted by individual state law.  

The removal of this barrier significantly increased the number of clinicians who may now provide lifesaving treatment for OUD. Additionally, the number of patients or patient caps (the number of patients who were allowed to be treated in a clinicians’ patient panel) that were previously limited was eliminated. 

Any clinicians who previously had the X-waiver will already meet the criteria. However, they will be required to attest to the specific training requirements, as their past trainings will count towards the new 8-hour requirement. For those holding a 30E waiver, they must attend a CE course to satisfy the new training criteria under the Consolidated Appropriations Act of 2023. It is imperative that clinicians know their respective state’s requirements, as these may differ from federal law. 

Exemptions to the new DEA requirements 

Exemptions also include those who are board certified in addiction medicine, anyone who graduated in good standing from an accredited medical school or residency, APRN, or PA program within the past five years whose curriculum included eight hours of substance use disorder.  

Education must include: 

  • Treating and managing opioid or substance use disorders with the appropriate clinical use of FDA-approved therapies specifically for OUD  
  • The safe pharmacological management of dental pain and screening 
  • Brief intervention and appropriate referrals to those patients considered at high risk for developing OUD 

First time registrations and renewals 

Those applying for their DEA registration for the first time or renewing their DEA registration will be asked to sign an attestation stating they have fulfilled the training requirement by having attended an 8-hour training or supply proof that they are exempt from this requirement.  

States expect that clinicians will be able to supply proof of completion of the 8-hour training should the DEA perform an audit on an individual’s application. Additionally, as of June 27, 2023, all clinicians must comply with these educational requirements when applying for or renewing their DEA registration.  

A total of 8 hours continuing education from an approved organization on opioid or other substance use disorders is required prior to renewing a current DEA registration. DEA registrations are renewed every 3 years at a cost of $888.00.  

Some states may also require an additional fee for a state DEA license. Both of these registrations are necessary if a clinician wants to prescribe any controlled substance. It is important to note that many employers will pay this fee if the clinician negotiates this upfront when they are being hired. Clinicians should be sure to check with their state board of nursing to determine what the specific requirements are for the state where they intend to practice.  

Evidence-based course content for DEA-registered clinicians

Courses included in this training must be evidence-based for the treatment of OUD. Content should be related to the prevention and recognition of SUD as well as care and a plan for those needing pain management. Validated screening tools for SUD include: 

  • The Tobacco, Alcohol, Prescription Medication and other substance use (TAPS) 
  • Alcohol Screening and Brief Intervention for Youth (NIAA) 
  • Opioid Risk Tool-OUD (ORT-OUD) 
  • Screening, Brief Intervention, and Referral to Treatment for Substance Use (SBIRT) 
  • Screening to Brief Intervention (S2BI)  

These tools can be utilized to help screen those at higher risk for OUD. It is essential that clinicians also assess other high-risk factors, including mental health disorders that are current or may yet be undiagnosed.