Digital behavioral health companies are rapidly reshaping the landscape of mental health care, offering patients faster access to treatment through virtual platforms. However, as the industry grows, regulators have begun scrutinizing virtual mental health prescribing, particularly when it involves controlled substances such as ADHD medications and treatments for opioid use disorder.
Done Global Inc., branded as Done., a virtual ADHD medication management company, has recently been linked in media reports to a potential investigation by the Drug Enforcement Administration’s (DEA) Diversion Control Division. Similarly, Cerebral Inc., known for providing rapid access to mental health prescribers, has reportedly received inquiries from DEA agents, according to the Wall Street Journal.
Despite these reports, Done has publicly disputed claims of any federal investigation. “Done has not received any notifications from the Drug Enforcement Agency, Department of Justice, or any other federal agency regarding an investigation,” a spokesperson said in an email. “Any reporting to the contrary would be false and inaccurate.”
The Growth of Virtual Behavioral Health Services
The rise of digital behavioral health providers has been fueled by increasing demand for accessible mental health care. Companies like Done and Cerebral promise convenient access to prescribers and medications, allowing patients to manage ADHD or addiction-related conditions without needing to visit a clinic in person. This expansion has highlighted both the promise and complexity of virtual mental health prescribing.
Investors have recognized this opportunity. Cerebral alone raised approximately $462 million in venture funding, including a $300 million Series C round valuing the company at $4.8 billion. These investments demonstrate confidence in telehealth as a scalable solution, even as regulatory concerns grow.
Regulatory Challenges and Controlled Substances
A core challenge for digital providers is prescribing controlled substances. ADHD medications like Adderall and opioid-use disorder treatments such as buprenorphine fall under strict DEA regulations: Adderall is Schedule II, while buprenorphine is Schedule III.
During the COVID-19 public health emergency, the DEA temporarily relaxed the in-person consultation requirement under the Ryan Haight Act, allowing providers to offer virtual mental health prescribing without face-to-face visits. This flexibility helped telehealth platforms grow rapidly, particularly in addiction and behavioral health spaces.
Pharmacy Access Complications
Despite regulatory allowances, access to medications remains a hurdle. Major retail pharmacies—including CVS Health, Walgreens, Costco, and Walmart—have reportedly become cautious about filling prescriptions from telehealth providers. Fierce Healthcare reports that some pharmacies have delayed or rejected prescriptions, requiring patients to complete in-person consultations first.
Ophelia Health, a digital addiction provider, confirmed that pharmacies sometimes “stonewall” prescriptions for medications like buprenorphine, creating barriers for patients who rely on virtual mental health prescribing for consistent treatment.
Lessons From Cerebral
Cerebral Inc. has faced public and regulatory challenges related to virtual mental health prescribing. The company is under a grand jury investigation by the U.S. Attorney’s Office for the Eastern District of New York over potential violations of the Controlled Substance Act. In response, Cerebral has wound down most controlled substance prescribing while continuing to provide other mental health services.
The company has also faced congressional scrutiny, removal from Aetna’s network, and rejection from CVS Health and Walmart pharmacies. These developments highlight the complexity of balancing innovation with compliance in digital behavioral health.
Done and Patient Access
Done has also encountered challenges. CVS Health pharmacies have declined some of Done’s prescriptions, causing delays for patients seeking ADHD medications. In a public statement, Done emphasized the importance of evidence-based treatment for ADHD and the role of virtual mental health prescribing in ensuring patient access.
“We hope that companies with a mission to ‘help people on their path to better health’ and that are ‘committed to patient safety and well-being’ would value deeply rooted evidence-based treatment for ADHD—a mental health condition—instead of placing additional barriers to care that millions struggle to receive daily,” Done said.
The Future of Telehealth Prescribing
The current regulatory environment demonstrates the challenges and opportunities inherent in virtual mental health prescribing. Telehealth platforms must navigate federal rules, pharmacy practices, and patient safety concerns while continuing to provide timely access to care.
For patients, understanding telehealth regulations and communicating with providers is essential to maintaining access to ADHD medications and other controlled substances. For providers, strengthening compliance protocols and advocating for balanced policies will be crucial to sustaining the growth and credibility of virtual mental health prescribing.
As digital behavioral health continues to evolve, ensuring safe, equitable access to care will remain a key focus for providers, regulators, and investors alike, shaping the future of mental health treatment.
