The DEA: Grappling With Telemedicine in a Postpandemic World

Telemedicine Prescribing Waivers Extended

On May 10, 2023, the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) announced they are extending the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications waiver for an additional six months (through November 11, 2023). These flexibilities have been in place since March 16, 2020, when the DEA and Department of Human and Health Services (HHS) declared the COVID-19 pandemic to qualify as an exemption to the Ryan Haight Act (aka the Ryan Haight Online Pharmacy Consumer Protection Act of 2008). Additionally, they added a one-year grace period (from November 11, 2023, to November 11, 2024) for any practitioner-patient relationship established during the waiver period.

This extension is a positive development for both patients and healthcare providers alike. Telemedicine can improve patient care outcomes, make accessing care easier, and reduce costs (time and travel-related expenses). Moreover, it demonstrates a significant change in position from the DEA’s proposed post-pandemic rules released on February 24, 2023.

Those proposed rules received a record 38,369 comments (mostly concerns and criticism) in the public open comment period. There were several themes in the comments: MAT (medication assisted treatment) for opioid use disorders, hormone-related treatment, ketamine treatment, rural access to care, encouragement to enact the Special Telemedicine Registration Process, and treatment for ADHD, among others.

The DEA’s initial proposed rules singled out ADHD (Thank you Done & Cerebral).

I’ll specifically discuss the proposed rules and how they would have impacted ADHD treatment. The DEA Controlled Substances Schedule is also included below for easy reference. The February 24 proposed rules essentially would have allowed for a single prescription of a non-narcotic Schedule III, IV, or V controlled substance (or buprenorphine for treating opioid use disorder) to be issued after a telemedicine-only examination. Said differently, the proposal would have allowed for any medication to be prescribed without an in-person visit except for opiates (makes sense), barbiturates (makes sense), and stimulant medications (doesn’t make sense).

Opiates are primarily prescribed to treat pain. Before prescribing such medication, a physical exam or medical imaging (i.e., an x-ray, CT scan, or MRI) would be warranted.

Barbiturates are primarily utilized to induce anesthesia, treat refractory seizures, or rarely as a treatment for migraines. Similar to opiates, a physical exam and/or medical imaging would be warranted. These medications are also not prescribed very often these days.

Stimulant medications are first-line treatments for ADHD treatment. There is no physical examination required. When was the last time your psychiatrist performed a physical exam? The diagnosis of ADHD can be made via clinical examination, neuropsychological testing, and/or a CPT (Continuous Performance Test such as TOVA, QBTest, IVA, etc.). There is no specific blood test or medical imaging that would diagnose ADHD.

Understandably, the DEA wants to ensure these medications are being prescribed appropriately. What’s incomprehensible is how slow the DEA has been to act in investigating companies such as Done, Cerebral, and other online startups that have made a mockery of prescribing these medications.

So now what?

The DEA and SAMHSA have commented they are still reviewing the record number of comments they have received. They will need to take those comments into consideration before publishing the final post-pandemic rules. Ideally, the proposed rules are released by no later than August 31st, with a similar month-long open comment period. This would allow Americans and various healthcare organizations to voice their support or concerns while also allowing them time (if needed) to prepare ahead of November 11th, 2023.