Cerebral Halts Controlled Substance Prescribing, Prepares for End of COVID-Era Regs

Cerebral Inc., a fast-growing mental health and medication management startup based in San Francisco, will stop prescribing most controlled substances by this fall.

Chief Medical Officer David Mou told the company’s prescriber team that Cerebral is pulling back on prescribing controlled substances “[in] order to prepare for the expiration of the waiver to the Ryan Haight Act,” according to an email provided by the company.

The stoppage for new patients is effective Friday. Cerebral will transition current patients to local care providers or off of controlled substances by October 15. However, Cerebral will continue to offer controlled substances through its recently announced medication-assisted treatment program.

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The waiver of the in-person prescription rules of the Ryan Haight Act from the Drug Enforcement Administration — along with other changes from regulators and payers — allowed telehealth to take off during the pandemic. This has been a market boon for behavioral health, especially startups in the medication-assisted treatment space.

“We have approached the crossroads where changes need to be made in our practice – changes which we do not take lightly, as they may negatively impact our patients who seek us out for exceptional mental health care,” Mou said in the email.

The company will provide the prescriber team — made up of physicians, nurse practitioners and nurses — with mandatory training modules and other resources to facilitate patient transitions, Mou said.

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The Wall Street Journal reported Tuesday that Cerebral CEO and Founder Kyle Robertson also told employees in an email about the cessation of prescribing controlled substances.

Cerebral’s ADHD medication prescribing practices have been under scrutiny for some time. The change in approach will also mean an end to all Adderall prescriptions.

The company announced the creation of a virtual MAT program in March. Cerebral executives previously told Behavioral Health Business the MAT program was part of building out a virtual mental health system that addressed common comorbidities, noting that substance use disorder and mental health issues often coincide.

Ongoing challenges for the Cerebral 

On May 7, Insider.com reported that the U.S. Attorney for the Eastern District of New York issued a grand jury subpoena regarding its practices related to prescribing controlled substances.

For months, Cerebral has garnered increasing scrutiny. In December 2021, the company announced it landed a $300 million Series C funding round that placed the valuation of the company at $4.8 billion.

In March, Bloomberg reported that Cerebral’s focus on medication prescribing and management has led to clinicians pushing medications, an allegation the company denies.

Truepill stopped filling Cerebral prescriptions of Adderall, according to a May 2 WSJ article. Additionally, WSJ reported on April 27 that CVS Health (NYSE: CVS) previously blocked certain Cerebral prescribers from prescribing Adderall.

Also at the end of April, Matthew Truebe, formerly the vice president of product and engineering at Cerebral, filed suit against the company over retaliation claims for apparently raising concerns about prescribing practices and safety issues.

Mou admitted the company has made some mistakes during its meteoric rise to prominence since its launch in January 2020 during an event at the American Telemedicine Conference in Boston.

But Mou reiterated that the company is focused on patient safety and care quality. He also played down the impact of potentially questionable controlled substance prescribing practices around ADHD saying that ADHD treatment was a small percentage of the company’s total business.

He said the “vast majority” of Cerebral’s business is focused on depression, anxiety, PTSD, adjustment disorder and, increasingly, bipolar disorder, Mou. Many of those mental health issues can be treated by prescriptions of controlled substances.

A few days later, Robertson announced on LinkedIn that the company was mixing up its leadership to put leaders high in the organizational chart that had an added focus on patient safety. The leadership announcement coincided with the announcement that Cerebral would halt prescribing controlled substances for ADHD treatment.

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