The Drug Enforcement Administration (DEA) has once again bought itself more time to figure out virtual telehealth prescribing.
Earlier this month, the agency announced that it would extend the flexibilities, which allowed providers to virtually prescribe controlled substances, including medication-assisted treatment (MAT) for substance use disorders (SUDs), as well as Adderall for ADHD.
The flexibilities have been overwhelmingly supported by the behavioral health industry and hailed as a way to expand access to patients amid a national opioid epidemic.
“The DEA’s extension of telehealth flexibilities of controlled substances is a lifeline for many mental health and substance use disorder patients,” Debbie Witchey, Association for Behavioral Health and Wellness (ABHW) President and CEO, told Behavioral Health Business in an email. “The option to provide buprenorphine-based treatment via telemedicine will enhance access to care and address health disparities. ABHW strongly supports removing the in-person requirement permanently for tele-prescribing buprenorphine as this requirement hinders access to care.”
The provisions were initially created in 2020 in response to the COVID-19 pandemic. However, the virtual environment has changed a great deal in the last four years, and patients and providers are reluctant to go back to old regulations.
The behavioral health industry has a major stake in keeping the changes. The flexibilities gave rise to more digital health companies focused on virtually treating substance use disorders (SUDs). Additionally, investors have poured millions of dollars into startups with a virtual-first business model.
But with a new administration taking over in January, there are still a lot of unknowns. Still, both the Trump and Biden administrations have been keen to address the opioid crisis and are proponents of telehealth expansions. And the flexibilities have now stretched over both administrations.
“It’s something that’s been in place for almost five years. The [flexibilities] were put in place by President Trump, kept in place by President Biden,” Kyle Zebley, senior vice president of public policy of the American Telemedicine Association and executive director at ATA Action, told BHB. “Hopefully, we’ll get a permanent framework that will allow for more predictability moving forward in that care area.”
In this update, I will examine:
The federal government’s options for finalizing telehealth flexibility
How the new administration could impact telehealth prescribing
What providers can do if telehealth flexibilities end
Regulatory outlook
Due to industry pressure, I can’t see the DEA ever completely throwing away flexibilities. Last year, the agency revealed a new proposal that would essentially end all telehealth prescriptions without an in-person visit.
The tightened regulations may have been in response to a few reckless companies in the space whose Adderall prescribing practices have come under fire.
Still, the agency received 38,000 comments in response to the proposals–the bulk of the comments support keeping more flexibility. In response, the agency extended the deadline for flexibilities.
This was an excellent example of how industry advocacy could help shape policy.
But extensions can only last so long, and ultimately, the industry wants a long-term solution. What will likely happen on the regulatory front? There are really two paths. Either the DEA will finally release the long-promised special registration process, which would give the DEA oversight over the process, or the DEA will come to a consensus with the Department of Health and Human Services on new regulations outside the special registration process.
Many advocates have favored the latter process, which would take some control out of the hands of a drug administration and into the hands of a healthcare administration. Still, the new administration’s pick for HHS Secretary, Robert Kennedy, previously advocated for non-medicated ways of recovering from SUDs, including “wellness farms” where individuals can go to get sober from substances.
Although Kennedy has been quiet on MAT specifically, his track record demonstrates he is skeptical of pharmaceutical companies and mainstream behavioral health medications.
On the other hand, the Trump administration is focusing on regulatory relief for the industry. Making these telehealth flexibilities permanent could be a low-hanging fruit for cutting the red tape in health care and a relatively easy win for the new administration.
The worst-case scenario for virtual SUD providers
If the DEA decided to do away with virtual prescribing of controlled substances without an in-person visit–which I think is very unlikely–providers have a few options going forward.
First, virtual SUD operators could partner with local providers. I think this is a smart move regardless of what ultimately happens with the DEA decision. This allows virtual partners to tick the in-person visit box without having to maintain all of the operations that go into running a brick-and-mortar clinic.
Partnerships could also foster robust referral pathways in the future. Busy community clinics could be keen to refer their patients to vetted virtual services.
The other option is taking a more hybrid approach to care. We’ve seen this with Eleanor Health, which provides the bulk of its services virtually but has in-person care locations.
The hybrid approach gives providers more control over their operations and oversight over patient care. The downside is the investment to start and maintain a brick-and-mortar site.
While these two pathways aren’t the only options, I think they are the most practical. Still, we’ve seen providers take other drastic measures. For example, in 2022, Bicycle Health flew clinical staff to Alabama to assess 300 patients in-person after the state implemented new legislation that barred clinicians from virtually prescribing controlled substances.
Although an interesting case study, it’s doubtful that efforts like this will be a practical solution to tightening regulations in the future.
Conclusion
Virtual prescribing for controlled substances, especially for SUDs, has been overwhelmingly popular. The new administration taking over in January can finalize telehealth flexibilities, which would likely gain bipartisan support.
Still, virtual-first MAT providers could take steps either through partnerships or a hybrid model to ensure that their business model is sustainable in the future.
