In March 2023, the U.S. Drug Enforcement Agency (DEA) announced new education requirements for all physicians applying for new or renewal DEA licenses. This was the result of provisions in the Consolidated Appropriations Act of 2023 that enacted a one-time requirement of 8 hours of continuing medical education (CME) on the treatment and management of patients with opioid or other substance use disorders. The requirement went into effect on June 27, 2023. Because DEA licenses are renewed on a rolling 3-year basis, all physicians with DEA licenses must meet this requirement sometime in the next 3 years.
Another provision of the Consolidated Appropriations Act of 2023 was to eliminate the DATA-Waiver (X-Waiver) Program that was previously required for physicians to prescribe buprenorphine. In the past, hospitalists, emergency medicine physicians, and other practitioners needed to obtain an X-Waiver to initiate buprenorphine when patients with opioid use disorder were admitted to the hospital or seen in the emergency department. Because only a small number of physicians took the time and effort to obtain an X-Waiver, the requirement was seen as a barrier to getting patients started on treatment. Now, any practitioner with a current Drug Enforcement Administration (DEA) registration may prescribe buprenorphine for opioid use disorder (if permitted by state law). The trade-off for elimination of the X-Waiver was the requirement that all practitioners with a DEA license be trained in the treatment of opioid use disorder, including the use of buprenorphine.
Who does this affect?
Any practitioner with a DEA registration must meet this requirement. This includes physicians, dentists, nurse practitioners, and physician assistants. However, only practitioners who prescribe controlled substances need to register with the DEA and obtain a DEA number. Although the majority of U.S. physicians have DEA numbers, some physicians do not, either by nature of their practice (for example, pathologists and researchers) or by choice (for example, general practitioners who do not want the hassle of prescribing opioids and other controlled substances).
To obtain a DEA number, a physician must apply to the DEA and pay an $888 fee. DEA numbers are valid for 3 years at which time the physician must re-apply. The DEA waives the fee for certain physicians including those who work in the military, for U.S. government hospitals or institutions, and for state government hospitals or institutions. As an employee of the Ohio State University (a state government institution), my DEA fees were waived. However, even if the fee is waived, the practitioner must still apply for and obtain a DEA number and the practitioner must still meet the new education requirements.
Certain practitioners are exempt from the new educational requirement including veterinarians, physicians board-certified in addiction medicine, and practitioners who have graduated from their professional school within the past 5 years. The latter means that most residents in training are exempt.
What are the specifics of the requirement?
When applying for a new or renewal DEA number, physicians (and other practitioners) must check a box attesting to having completed 8 hours of training on treatment and management of patients with opioid or other substance use disorders. This is a fairly broad topic area and it is up to physicians to maintain their own documentation of completion of education in the event of an audit. In addition, if the physician faces legal action (such as a medical malpractice lawsuit), documentation of completion may be necessary to establish physician competency. The details of the requirement are as follows:
- The 8 hours of education do not need to occur in one session and (for example) can be 8 individual 1-hour CME events.
- This is a one-time requirement and will not need to be repeated every three years when re-applying for a DEA number.
- Education can take the form of grand rounds, classroom sessions, on-line materials, or professional society meetings.
- Education hours obtained prior to the new requirement also count. For example, attending a grand rounds on buprenorphine in past years can count; just be sure that you have documentation of participation or attendance. Physicians with an X-Waiver can count the training hours from their original X-Waiver application.
- The education can come from any organization accredited to provide CME credits by the Accreditation Council for Continuing Medical Education.
What do hospitals need to do?
Although the DEA requirement is left to the responsibility of the individual practitioner applying for a DEA number, hospitals do have an obligation to facilitate education. First, if practitioners fail to get the required 8 hours of training and are unable to obtain a DEA number, the hospital’s ability to dispense controlled substances or manage patients requiring controlled substances will be compromised. Second, in the event of a medical malpractice lawsuit involving a practitioner on the medical staff who lacks documentation of completion of the educational requirements, the hospital could be accused of being complicit by not confirming that their practitioners were appropriately trained. Specific steps that hospitals should take now include:
- Make sure that all members of the medical staff are aware of the new DEA requirements.
- Inventory practitioners’ DEA license expiration dates and remind practitioners at least 6 months in advance of that date that they must fulfill the educational requirements prior to the renewing their DEA number.
- Require practitioners with DEA numbers to submit documentation of completion of the educational requirements and then maintain that documentation in each practitioner’s employment record.
- Require any new practitioners to include documentation of completion of substance abuse treatment CME as part of their application to the medical staff. Those lacking documentation should be required to complete training during their provisional/probational appointment period.
- Schedule grand rounds or other CME events covering treating and managing patients with opioid or other substance use disorders.
- Provide practitioners with links to on-line CME resources. For nearly a quarter of a century, I moderated the CME webcast, OSU MedNet-21. We produced many CME webcasts on substance abuse disorders and these webcasts are available to anyone. A recent example is:
- Many professional societies have included sessions on substance abuse disorders as part of their annual meetings or have prepared on-line CME sessions to help fulfill the requirements. Examples of on-line education programs include:
- The Centers for Disease Control offers a free on-line 1-hour CME activity about substance abuse disorders
- Journal subscription materials can count. Practitioners with subscriptions to resources such as UpToDate, JAMA, and the New England Journal of Medicine can obtain CME credit by reading relevant articles and then applying for CME hours.
Why has Congress required this?
The primary impetus for the new requirement is a directive of the U.S. Congress to address the opioid epidemic. Eliminating the X-Waiver program was seen as a way of improving access to treatment for patients with opioid use disorder. But to justify elimination of the X-Waivers, Congress needed a mechanism to ensure that all practitioners were knowledgable in initiating treatment for opioid use disorder.
In 2021, a total of 106,699 Americans died of a drug overdose. Although street-purchased fentanyl was the most common drug implicated, prescription opioids accounted for 16,706 of the overdose deaths in 2021. In fact, the number of deaths from prescription opioids exceeded the number of deaths from heroin (9,173).
Drug overdose deaths are particularly high in Appalachian states. West Virginia has the highest overdose death rate at 90.9 per 100,000 population, followed by Kentucky and Tennessee (each 56.6 per 100,000 population) and Louisiana (55.9 per 100,000 population). My state of Ohio ranks 7th highest at 48.1 per 100,000 population. Nebraska comes in lowest at 11.4 per 100,000 population.
To put these numbers in perspective, last year, the U.S. COVID death rate was 61.3 per 100,000 population. Opioids are abused by more than 10 million Americans each year (3.8% of Americans) and 2.7 million Americans have an opioid use disorder. About half of those who become addicted to opioids first use opioids in the form of prescription pain medications. An estimated 3% – 19% of people who take prescription opioid pain medications will become addicted to opioids. Addiction can occur with only 3-5 days of prescription opioid use.
The good news is that there are effective treatments for opioid use disorder including buprenorphine (often combined with naloxone), methadone, and naltrexone. In addition, the FDA has now approved naloxone to be sold over-the-counter to treat opioid overdose. The goal of the DEA education requirements is that any practitioner in the U.S. who is licensed to prescribe opioids is also trained in identifying and treating opioid abuse.
A quarter of a century of change
In the 25 years since the American Pain Society advocated that physicians adopt “pain as the 5th vital sign” and since Purdue Pharmaceuticals falsely promoted OxyContin as a non-addictive opioid, physicians have become much more aware of the role that we have played in catalyzing the current opioid epidemic. The new DEA education requirements were created as one step in remedying the epidemic. By helping our physicians meet these new requirements, hospitals can help reduce the number of Americans who become addicted and help increase the number of Americans who get their addiction treated.
August 28, 2023