Disclosure: The author was convicted and served time after he prescribed pain medication outside the scope of medicine to an undercover Drug Enforcement Administration (DEA) agent. Joshi has since regained his medical license, resumed clinical practice, and is seeking to vacate his conviction.
With the elimination of the X-waiver requirement, all DEA-registered practitioners can prescribe medications to treat opioid use disorder. Now, in place of the X-waiver, the DEA instituted a new training requirement: a one-time, 8-hour online training administered through a select number of accredited medical societies.
Soon after this news broke, Regina LaBelle, JD, former acting director in the Office of National Drug Control Policy (ONDCP) and current director of the Addiction and Public Policy Initiative at the O'Neill Institute at Georgetown University Law Center, tweeted that the training program "...Won't be a game changer, but it will set the course for prescribers to understand more about addiction."
I decided to reach out to LaBelle to clarify her stance. She explained:
"The reasons why mainstream healthcare doesn't screen individuals for substance use disorder or treat addiction are complex. These reasons include stigma, not wanting people with addiction in their practice, as well as not fully understanding how to treat addiction. While this one time education is important, by itself, it's not enough to create the comprehensive system of care for addiction needed in this country."
Creating that type of comprehensive care system would require unprecedented integration among a diverse array of government agencies, medical specialties, and payer systems. Absent such an overhaul, we are left with various medical organizations and federal agencies pursuing differing aims that often appear at odds or, at the very least, ambiguously connected.
To address this disjointedness, LaBelle believes medical societies should design addiction training programs that are customized for each specialty in order to provide "...practitioners with familiarity with addiction screening and addiction treatment, as well as resources where they can obtain additional information to guide their ongoing practice."
While this sounds reasonable, I believe this will do little to resolve the matter in actual clinical practice. Medical societies are not the ones enforcing laws and regulatory policies overseeing the treatment and management of these patients -- that would be the DEA. Yet, the DEA has not taken a stance on harm reduction, a clinical approach to care strongly advocated for by nearly all medical societies.
This ambiguity puts practitioners in a difficult position. Policy makers expect medical societies to educate practitioners on addiction-specific treatment and to guide individual clinical decisions and patient treatment. But true oversight comes from a distinctly non-clinical federal agency. To date, any semblance of collaboration between medical societies and the DEA has been through perfunctory training modules that policy experts like LaBelle acknowledge are not as effective as they could be.
Both practitioners and policy makers should advocate for greater collaboration. Clinical practitioners need to understand how the training programs they are required to take help them make specific clinical decisions that balance the need for adequate patient care with the need for broader oversight.
That requires the DEA to clarify how it oversees the treatment of patients with opioid use dependency. And that begins with the DEA clarifying its stance on harm reduction. After all, an organization that regulates the prescribing of opioids should explain how it believes clinical decisions concerning opioid prescriptions should be made.
Understandably, the DEA might be leery. In 2022, the CDC revised its controversial 2016 guidelines for opioid prescribing after outcries claiming the guidelines were misused and codified into law instead of merely serving as recommendations. And even after the revision, the CDC still hasn't gotten it fully right.
It's precisely this ambiguity that the DEA should proactively address. A growing body of medical literature suggests harm reduction improves individual patient outcomes. Many states and municipalities have already enacted policies that provide fentanyl strips and naloxone (Narcan) dispensaries. But the most meaningful changes in addiction treatment oftentimes occur during the patient encounter. We should encourage practitioners to treat addiction as they would any chronic condition. This starts by destigmatizing addiction so they see it as a clinical disease. This unfortunately won't happen until practitioners believe they're not at risk of legal or even criminal liability when treating patients with opioid dependencies.
Practitioners need clarity from the DEA. The agency effectively dictates the course of addiction medicine through the enforcement of the Controlled Substances Act. Their interpretation of this statute determines how the federal law is enforced. In the minds of practitioners, this carries greater sway than any recommendation by a medical society.
Until clinical recommendations from medical societies are coordinated with legal enforcement from the DEA, practitioners will have to choose between a potentially "risky" approach or choose to be legally self-protective. I suspect that in most cases, they'll choose the latter, at the peril of patient care. We've already seen the consequences of this: overdose rates remain shockingly high, and practitioners continue to limit access to addiction treatment.
Nothing will change until we offer clinical recommendations with sufficient clarity to change clinical decisions. We need the DEA to work closely with medical societies and develop specialty-specific programs that offer clarity on the medical and legal implications of addiction treatment. To accomplish this, we need the DEA to take a stance on harm reduction, so we can finally reconcile opioid health policy with the clinical decisions to prescribe them.
Jay K. Joshi, MD, is a practicing physician and entrepreneur in Northwest Indiana. His upcoming book, Burden of Pain, identifies opioid health policies that can bridge the divide between the legal and clinical worlds.