Cerebral, an online mental health care service platform, is now under investigation by the Department of Justice for possible criminal violations of the Controlled Substances Act.
The company treats a variety of conditions, including depression, anxiety disorders, ADHD, PTSD and serious mental illnesses such as bipolar disorder and opioid use disorder. Through its virtual services, Cerebral offers both behavioral and medication-based care.
The Controlled Substances Act covers the manufacturing, importation, possession, use and distribution of certain substances, including the distribution of medications such as Xanax and ADHD medications. Cerebral was issued a grand jury subpoena by U.S. Attorney for the Eastern District of New York asking the company to turn over documents related to the company’s prescribing of controlled substances. The news was first reported by Insider.
As a result, the company stated it will pause the practice of prescribing controlled substances as a treatment for ADHD such as Adderall and Ritalin for new patients starting May 9. Existing patients will continue to receive their clinically appropriate, prescribed medications, while the company adds new tools to safeguard its prescription practice.
“Clinical quality and safety are at the forefront of what we do, which is why we have decided to pause part of our ADHD service line,” Kyle Robertson, CEO and founder of Cerebral, said in a statement. “Based on recent feedback from stakeholders, it is clear that this has become a distraction from our focus to democratize access to mental healthcare services, provide treatment for more patients and add service lines for new conditions.”
Cerebral launched in January 2020, just before the onset of the COVID-19 pandemic in the U.S. The company quickly gained customers as traditional healthcare providers temporarily shuttered to reduce the spread of the virus and leverage more resources for COVID-19 patients. In addition, mental health concerns have risen since the start of the pandemic.
Beyond changing its practice for ADHD treatment, Cerebral also implemented a handful of other changes in light of the investigation. The company has added more safeguards to its clinical safety protocols, including administering additional assessment capabilities, such as urine drug screens and PHQ9 and GAD7 screeners, to give clinicians more information on their patients. Cerebral is also developing new EMR tools and instituting more effective communication tools.
Plus, Cerebral said it is reviewing its compensation practices for clinicians to ensure they align with its value-based care model, as well as adjusting its marketing and advertising strategies. The company has brought in a new creative director to lead in-house creative development and work closely with the company’s clinical teams. The company also promised to continue to review, identify areas of improvement and implement other initiatives and is already in the process of establishing an independent internal audit practice for its clinical care processes with its new head of compliance.
“It is regrettable that a helpful class of medication that is considered a first-line treatment option has become so stigmatized,” David Mou, MD, chief medical officer and president at Cerebral, said in a statement. “We hope this will change as a population of people with clinical needs are no longer able to access care with us.”