Virtual ADHD drug management company Done Global Inc. (brand name for Done.) is reportedly under investigation by the Drug Enforcement Administration’s Diversion Control Division.
Agents from the DEA’s diversion management division also made similar inquiries to Cerebral Inc., a virtual mental health company that promised rapid access to mental health prescribers, The Wall Street Journal reported.
However, a Done Global representative refuted claims that the company was investigating.
“Dan has not received any notice from the Drug Enforcement Administration, the Department of Justice or any other federal agency regarding the investigation,” the spokesperson said in an email. “Any report to the contrary is false and inaccurate.”
Several digital-behavioral therapy startups have faced backlash for prescribing controlled substances such as Adderall, the brand name for a mixture of amphetamine salts used to treat ADHD, and buprenorphine, an opioid use disorder drug.
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 its potential for abuse and potential for dependence.
Retail pharmacy operators within Walgreens, Costco, CVS Health, and Walmart have become wary of controlled substance prescriptions from digital behavioral therapy companies over the past few months, according to a Fierce Healthcare report.
Digital provider Ophelia Health told BHB that some retail pharmacies have interfered with prescriptions for controlled substances like buprenorphine or refused prescriptions by requiring patients to seek direct consultation from the prescriber first. rice field.
In-person consultations are typically required for telemedicine providers to prescribe and manage patients who use controlled substances. However, in response to the public health emergency, the DEA has temporarily suspended these face-to-face requirements, part of the Ryan Haight Act amendments to the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970. Stopped.
This has allowed virtual behavioral health providers to thrive and garner huge funding rounds, especially in the addiction space.
Headline-making investments, the rapid growth of several start-ups, and allegations of poor prescribing practices are also emerging during these COVID-era regulations.
Cerebral Inc. has encountered several of these instances.
Since its inception in 2019, Cerebral has raised approximately $462 million in venture capital, including a $300 million Series C funding round that raised $4.8 billion.
In June, news surfaced that the US Attorney’s Office for the Eastern District of New York had launched a grand jury investigation into the company based on possible violations of the Controlled Substances Act.
Since then, the company has faced intense scrutiny while deciding to scale back its prescriptions for most controlled substances, citing concerns about the uncertain length of regulation in the COVID-era.
The company has also been subjected to congressional scrutiny, removed from Aetna’s network, and rejected by Walmart and CVS Health pharmacies.
Done was similarly rejected by CVS Health’s pharmacy, the company said in a statement to BHB.
Done acknowledged in a statement on its website in August that many patients experienced delays in receiving their ADHD medications due to pharmacy issues.
Done said such a move “does not justify patients’ need for telemedicine treatment.”
A company with a mission to “help people on their path to better health” and a company that is “committed to patient safety and well-being” evaluates strong evidence-based treatments for the mental health condition ADHD. I hope It imposes further barriers to the care that millions of people struggle to receive every day,” the statement said, citing language from CVS Health’s previous public statement.