The virtual ADHD medication management company Done Global Inc., branded as Done., is reportedly under investigation by the Drug Enforcement Administration’s Diversion Control Division.
DEA diversion control division agents have also made similar inquiries to Cerebral Inc., a virtual mental health company that promised speedy access to mental health prescribers, according to a Wall Street Journal report.
However, a Done Global official pushed back against the assertion the company was under 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.”
Several digital behavioral health startups have faced pushback in prescribing controlled substances such as Adderall, a branded drug name for a mixture of amphetamine salts used to treat ADHD, as well as the opioid-use disorder drug buprenorphine.
Both Adderall and buprenorphine are listed as controlled substances by the DEA. Adderall is a schedule II drug while buprenorphine is a schedule III drug based on their potential for abuse and possible dependence.
Retail pharmacy operators within Walgreens, Costco, CVS Health and Walmart have over the last few months become wary of prescriptions for controlled substances from digital behavioral health companies, according to reporting by Fierce Healthcare.
Digital provider Ophelia Health told BHB that several retail pharmacies have either stonewalled their prescriptions for controlled substances like buprenorphine or have rejected them by requiring the patient to first have an in-person consultation from the prescriber.
In-person consultations are typically required for telehealth providers to prescribe and manage patients with controlled substances. However, the DEA temporarily paused these in-person requirements, part of the Ryan Haight Act amendments to The Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, in response to the public health emergency.
This has allowed virtual behavioral health providers, especially in the addiction space, to thrive and land huge funding rounds.
The headline-grabbing investments, the rapid growth of several startups and allegations of inappropriate prescribing practices have also appeared during these COVID-era regulations.
Cerebral Inc. encountered several of these instances.
Since its founding in 2019, Cerebral has raised roughly $462 million in venture funding including a $300 million Series C funding round that came with $4.8 billion.
In June, news surfaced that the U.S. Attorney’s Office for the Eastern District of New York launched a grand jury investigation into the company based on a potential violation of the Controlled Substance Act.
The company has since decided to wind down prescribing most controlled substances, citing concerns around the uncertain length of COVID-era regulations, while it has faced heavy scrutiny.
The company has also faced congressional scrutiny, been removed from Aetna’s network and been rejected from Walmart and CVS Health pharmacies.
Done has similarly been rejected from CVS Health pharmacies, the company said in a statement to BHB.
In August, Done acknowledged that many patients had experienced delays in getting their ADHD medication due to issues with pharmacies in a statement on its website.
Done said such moves “delegitimize patient’s needs for treatment via telehealth.”
“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,” the statement said, citing language from previous public statements from CVS Health.
Companies featured in this article:
Cerebral, CVS Health, Done Global, Drug Enforcement Administration
