The $4.8 billion mental-health startup Cerebral just announced a major change to its business, as it faces mounting scrutiny from federal investigators over how it prescribes controlled substances.
In an email to staff Monday evening, Cerebral CEO Kyle Robertson said the company's clinicians will stop prescribing most controlled substances to new patients starting May 20 and to existing patients starting October 15. Controlled substances like the benzodiazepine Xanax and the stimulant Adderall are classified as such because of the risks involved with prescribing, such as the potential for addiction.
"We want to assure you that we are confident in the future of the business. While we will no longer provide care using controlled medications, we will continue to provide a holistic approach to care with both behavioral and medication-based treatments (when clinically appropriate)," Robertson wrote in the email seen by Insider.
Cerebral confirmed the decision to Insider in a statement.
"We can confirm tonight that the company's leadership team has made a unanimous decision supported by its board of directors to move forward with a decision to no longer offer mental health services involving the prescription of controlled substances," Cerebral said on Monday. "This decision was spearheaded by our clinical and regulatory teams, and we will be releasing more details about how we will do this safely and in the best interests of our patients and clinicians later this week."
Cerebral, backed by venture-capital firms, including SoftBank and Oak HC/FT, provides medication and therapy online to people with anxiety, depression, ADHD, and other conditions.
The move to discontinue controlled substances comes after months of increasing scrutiny from the federal government, newsrooms, and pharmacies over its prescribing practices.
Prior to the coronavirus pandemic, federal law prohibited clinicians from prescribing such highly regulated drugs to patients without an in-person appointment. Only a handful of companies took advantage of relaxed rules for prescribing controlled substances online amid the public health crisis.
In the email, Robertson said Cerebral began prescribing controlled substances in 2020 at the height of the pandemic when people lacked access to the in-person care required to receive those medications. It's making the change now because of the ability for patients to return to an in-person or hybrid care model, he said.
Cerebral previously said it would halt prescribing controlled substances like the stimulant Adderall for new patients with ADHD starting in May, The Wall Street Journal reported. National pharmacy chains had expressed concerns that clinicians at Cerebral and another company are writing too many prescriptions for stimulants, per The Journal.
Federal agencies have also taken notice of Cerebral. The US Drug Enforcement Administration and the US Department of Justice are investigating the startup, as Insider exclusively reported in May.
Cerebral will continue writing prescriptions for Suboxone
Robertson said patients with existing prescriptions for controlled substances to treat conditions like ADHD and anxiety will be notified of the upcoming changes and encouraged to visit with their Cerebral clinician to develop a plan to taper off their current medication and begin another treatment option, or transition away from Cerebral's care.
Cerebral will continue to prescribe controlled substances to patients with opioid use disorder, however, because of the lack of access to such care, Robertson said. The company launched a program to treat opioid use disorder with Narcan and the controlled substance Suboxone in March.
Cerebral is making other changes to its clinical policies and marketing strategies to ensure quality of care and patient safety, Robertson said in the email.
Further, Robertson said Cerebral is recruiting more psychiatrists and psychiatric nurse practitioners, and it's reviewing how it pays its clinicians "to ensure that all incentives align with a value-based care model," the email said. Cerebral has relied largely on nurse practitioners to prescribe medication to patients.
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