Cerebral’s CEO responds to concerns about prescribing pressures and telehealth safety

youhe three years since the release of Cerebral have been a whirlwind. Promising to expand access to mental health care and medications online, the company secured a staggering $462 million in funding from the end of 2021. But by the summer of 2022, the company was under intense pressure as its prescribing and business practices scrutiny from federal and tax agencies.

As Cerebral navigates the fallout from those investigations and a rapidly changing telehealth landscape, its CEO emphasized that Cerebral is working to improve the quality of mental health care.

“I am very confident in the clinical aspect of what we have been doing and what we are doing in the future,” David Mou, a physician who took over as CEO of the embattled company in May, he said Wednesday at the STAT Summit.

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When Cerebral launched in 2020, the San Francisco-based startup lured clients with a subscription-based approach to mental health care, targeting conditions like anxiety, depression, and attention deficit hyperactivity disorder. . But in May, it was reported that the company was being investigated by the Drug Enforcement Administration and had been aforementioned for possible violations of the Controlled Substances Act. Pharmacies, including Walmart and CVS stopped filling prescriptions of Cerebral’s controlled substances, and the following month, the Wall Street Journal reported The Federal Trade Commission was investigating whether the company engaged in deceptive or unfair practices.

Around the same time, Cerebral stopped prescribing controlled substances such as Adderall and Ritalin online, citing the fact that drugs had “become a distraction from our focus to democratize access to mental health care services.” But Mou, instead, framed the change as a clinical decision, pointing out the imminent return of pre-pandemic regulations that would limit the exclusive telehealth prescription of controlled substances.

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“We hear that in the next few months Ryan Haight is going to return,” Mou said, referring to the 2008 law that requires an in-person consultation in most cases before a prescription for a controlled substance. “We didn’t want to gamble and… have a month to reduce the use of those drugs in all of our patients, hundreds of thousands of patients.”

Mou also rejected the idea that Cerebral’s business model could put pressure on doctors to prescribe drugs, such as reports about his clinical practices to have He suggested. “We encourage people to follow clinical guidelines,” Mou said, adding that providers are not given quotas on diagnoses, medications, types of medications, or dosages. “And that has been true since day one since I was there,” said Mou, who joined Cerebral as chief medical officer in February 2021, taking over from co-founder Ho Anh.

“I think there is a big intersection here between what is good for the business and what is good for the patient,” he added.

Cerebral’s challenges have raised questions about how to safely deliver behavioral health care in a virtual setting and what care is best delivered in person. But Mou refused to draw a hard line between the two. “I don’t think it’s telehealth versus brick and mortar,” she said. “I think it’s evidence-based care versus non-evidence-based care, high-quality care versus care that’s not high-quality. In fact, I see the future as brick and mortar and telehealth, and that patient can seamlessly move between the different continua.”

Mou repeatedly invoked the idea that existing face-to-face care is insufficient for patients, and not just because of how difficult it can be for patients to access psychiatric care and therapy, a common refrain from telehealth advocates. Instead, he pointed to the lack of standardization in existing behavioral health practices, both in prescribing and in tracking outcomes.

“This is a big problem in the field of mental health, but we don’t have a gold standard metric,” Mou said. “It’s not like diabetes where we have a hemoglobin A1C and all doctors can agree that’s the standard.” With platforms like Cerebral, she said, more standardization is possible.

“Telehealth can be very, very beneficial in measuring clinical outcomes and process outcomes that are important,” Mou said. As an example, she pointed to Cerebral’s efforts to track metrics like suicidality, emergency room admissions, and hospitalizations.

But when asked if his internal metrics are established measures of clinical quality, Mou acknowledged that they are a work in progress. “You have to start somewhere,” Mou said. “In short, we need to agree as a field on what that is. But in the meantime, we’re going to measure as much as we can.”

Mou also described novel tools in Cerebral that could identify patients who need additional support. “We have one of the most proactive suicide prevention programs,” she said, based on the text messages patients send to providers. “Some of them say, I want to commit suicide. I no longer want to continue and I no longer want to wake up. We use machine learning to immediately identify them.” She also described a program under development to similarly identify signs of domestic violence in text messages.

Mou said that the data-driven approach is key to scaling Cerebral’s business, which is facing economic difficulties: at the end of October, the company announced its second round of layoffs this year, cutting another 20% of its staff in the operations, support and clinical care teams. He described how the company uses a series of criteria to identify high-risk patients, matching those select users with a complex case manager. “Because we have this data, we can focus on the patients who really need it and give them that high level of support,” Mou said. “This is all about data science, really knowing our patients and deploying our resources in a way that optimizes clinical outcomes.”