Embattled startup Cerebral tripling down on clinical quality, safety efforts, CEO says, amid escalating mental health crisis

Mental health startup Cerebral launched two and a half years ago, and the company says it has now treated over half a million patients.

Cerebral is one of many telehealth-focused mental health companies that saw explosive growth at the onset of the COVID-19 pandemic fueled by increased demand for virtual care services.

In 2020, 1 in 5 U.S. adults experienced a mental illness, but the country faces a growing clinician shortage. The pandemic has only exacerbated this problem. A recent study from the American Journal of Preventive Medicine finds widespread increases in depression yet troubling gaps when it comes to access to treatment.

Telehealth is helping patients who historically have been disenfranchised or lack the resources for traditional treatment, said David Mou, M.D., a psychiatrist who now helms the startup as CEO.

"The majority of our patients have salaries below the national average," Mou said in an interview. "We're not catering to a wealthy populace who are switching between different therapists and psychiatrists on the Upper East Side; that's not what this is."

Mou tells the story of a Cerebral patient living in a rural area who would take his virtual care appointments on his phone while in his pickup truck.

"One day we decided to ask him, 'Why are you in your pickup truck?' And he said, 'Look, I'm not ready to tell my wife and my kids that I have depression, and I need care for it. But I also don't make enough money to have a private office where I can take these calls privately, so you need to meet me where I am. And here's where I am. I'm tired of meeting new doctors where you are all the time.' I think that's particularly profound and it really encapsulates the power that telehealth has to democratize access to healthcare."

Mou joined Cerebral in February 2021 as chief medical officer. He was promoted to CEO in May after former CEO and co-founder Kyle Robertson stepped down just as the company faced a Department of Justice investigation. Prior to Cerebral, Mou was the president, chief medical officer and co-founder of telepsychiatry company Valera Health. He was educated at Harvard and served as the director of the Innovations Council for Massachusetts General Hospital’s psychiatry department. 

"It was my mandate to begin to build out the clinical safety and quality teams, and we have built out a number of these efforts throughout the last few years," he noted.

Cerebral provides comprehensive, online mental health services for depression, anxiety, PTSD, attention-deficit/hyperactivity disorder (ADHD), bipolar disorder and a range of other conditions. 

In a newly published "State of Care" report, Cerebral outlines a number of its initiatives to significantly improve quality of care and safety protocols.

The company has stepped up efforts to use data to better match patients with clinicians based on patient preference and clinical need. Company executives say Cerebral's approach improves speed to care as more than 90% of patients are offered an appointment within the first five days versus the typical wait time of weeks to months.

The company also built a proprietary electronic medical record system to track data such as patient engagement, clinical progress and clinical risk. Through the EMR, Cerebral tracks clinical measures including patient-reported outcomes, medication adherence and hospitalizations.

"We're putting in many, many more efforts and committing a lot of resources to getting this right," Mou said.

Cerebral is striving to set the standards for "high-quality mental health care" in the industry, he said. The current mental health care system is "broken," he said, as patients often wait months to get care. The majority of mental health professionals do not measure clinical outcomes systematically or use electronic medical records.

Cerebral is focused on using data, telehealth and technology to raise the bar and add much-needed measurement and a sufficient number of providers to the industry, he noted.

"We have to bring measurement-based science into psychiatry and into mental health in general," Mou said. "It would actually help reduce the stigma as we begin to say, 'Here are the interventions, and you can see the quantified difference between where you were and where you are today.'"


Facing increasing media, regulatory scrutiny
 

These changes come as Cerebral faces intense media scrutiny and federal probes into its business practices. Cerebral is currently mired in a Department of Justice investigation into its prescribing practices and "possible violations" of the Controlled Substances Act. In June, Cerebral Medical Group received a grand jury subpoena from the U.S. Attorney’s Office for the Eastern District of New York. The Controlled Substances Act regulates the distribution of potentially addictive medicines like Adderall and Xanax.

The Federal Trade Commission also is investigating whether the mental health startup engaged in deceptive or unfair practices related to advertising or marketing.

"Cerebral is working with regulators to respond to their requests and educate them about Cerebral's practices and commitment to quality. No regulator has accused Cerebral of any wrongdoing or violation of any law," the company said in a statement.

In May, the company announced it will no longer prescribe most controlled substances to patients, citing the eventual expiration of telehealth waivers that allowed online prescriptions for drugs like Xanax and Adderall.

"In anticipation of the end of the Public Health Emergency waiver to the Ryan Haight Act, in May Cerebral's clinical leadership decided to cease prescribing controlled substances to new patients. As clinically indicated, patients who were prescribed a controlled substance before May are either being tapered off of controlled substances or being transitioned to providers who can provide in-person care," a company spokesman said.

Cerebral also is in the media spotlight amid claims that it treated minors. A recent report in The Wall Street Journal states that the company had systems in place to verify customer IDs but was not using them to check details such as age, leading to minors being treated without parental consent.

The parents of 17-year-old Anthony Kroll claim he signed up for Cerebral, told a Cerebral clinician he had suicidal thoughts and received a prescription for an antidepressant without their knowledge, according to the WSJ report. The Krolls said they didn’t know their son was suicidal and was receiving mental health treatment until a few hours before he committed suicide, the WSJ reported.

"Any loss of life is very tragic, and our hearts go out to family members of the patient," Mou told Fierce Healthcare.

A Cerebral spokesman told the WSJ that Anthony misrepresented his age, the company regrets he received care without parental consent and the treatment he received was appropriate. “This case is an unfortunate outlier,” the spokesman said. “Any loss of life is tragic, and we extend our deepest condolences to the family.” 


Building more robust quality, safety protocols
 

Verifying patient IDs is a major issue for the growing telehealth industry. Telehealth providers have to ensure they aren't treating minors without consent or prescribing to patients in states where clinicians aren’t licensed. 

Cerebral's ID verification process is "above market standards," Mou said, as the company uses software that can detect whether a patient's identification, such as a driver's license, is real. This process is an improvement over typical brick-and-mortar facilities, where ID checks are done manually by front-office staff, he noted.

He acknowledged the need for improvements, and Cerebral is working to implement one of the best age and identity-verification processes in the telehealth industry, one that meets or surpasses legal requirements, the company said. Cerebral is adding software features to check birthdates to ensure that "no one under the age of 18 is treated by Cerebral."

"This is in addition to the clinician verifying [the ID] as well," he said.

Among brick-and-mortar providers, many patients who are suicidal get "lost to follow-up," Mou said. "They just don't show up to the appointment. But you don't track them. You have no data on them. You give them a phone call, it goes to voicemail, and that's it. That is the status quo, and it's really terrible and it's a problem."

Many patients who come to Cerebral for treatment suffer from serious mental illnesses. "Many come to us with suicidal thoughts and behaviors, and they have nowhere else to turn," he said. "Many clinics actively avoid patients with a history of suicidal thinking. Both telehealth and brick-and-mortar providers actively discriminate against patients with past histories of suicidal thinking and suicide attempts. It's an unfortunate situation here where our mental health system disadvantages the patients who need the care absolutely the most right now."

He added, "I think it's really imperative for us to build out a system that can take care of these patients who have been historically disenfranchised. We have built out a very high-quality and safe system to work with patients with suicidal thinking. We take pride in supporting these vulnerable patients."

Cerebral is currently expanding its internal infrastructure and internal safeguards to prioritize vulnerable patients, especially where suicide is a risk. 

Cerebral also uses technology to improve patient safety and crisis detection such as deploying machine learning to better screen patients who are at risk. Its crisis response system integrated into its electronic messaging system can detect messages from patients experiencing a crisis. Software can detect statements in the patient portal, remarks during a clinical call or a service call or comments and messages made on social media that may indicate a patient in crisis, according to the company. Cerebral can then connect these patients to crisis response specialists within minutes. 

Cerebral also has developed dedicated clinical quality and clinical safety teams run by psychiatrists, Mou noted. And the company is working with suicide expert Matthew Nock, Ph.D., to establish a "high-acuity client framework" to identify and customize care for high-acuity patients.

Cerebral clinicians also are financially incentivized to contact patients more frequently if they have expressed suicidal ideation. "We're incentivizing them to provide better care and more timely care, more empathetic care for our most vulnerable patients. We've demonstrated that doing that gets these patients more engaged in care," he said. "I hope one day we can say we save lives because we averted suicide attempts."

According to Mou, this approach has led to better patient outcomes. About 50% of patients who initially report suicidal ideation no longer harbor suicidal thoughts after an average of six months of treatment with Cerebral, according to the company's "State of Care" report.

In the past two years, Cerebral has been criticized for spending heavily on social media ads and offering stimulant prescriptions for ADHD. 

Cerebral executives now say the company is "reallocating resources from growth marketing to clinical quality efforts and patient experience," according to a blog post.


Expanding access for high-acuity patients
 

Many telepsychiatry platforms focus on treating individuals with low- to medium-acuity conditions. Cerebral says it provides care to patients across the full spectrum of acuity—from mild and moderate depression and anxiety to serious medical illnesses like bipolar disorder.

The company has built up a network of more than 3,000 clinicians in all 50 states, and Cerebral is now considered the largest online mental health care provider. Care teams consist of prescribers, therapists, care counselors/coaches and coordinators.

Cerebral also boasts that it has a diverse team of clinicians, nearly half of whom identify as nonwhite, to help patients find the clinician that best matches their needs and preferences.

The company built a clinical decision support tool to encourage clinicians to follow evidence-based decisions and provide clinical guidelines for prescribing patterns, Mou said.

With a focus on team-based care, Cerebral also developed a "curbside consults" service that connects clinicians and nurse practitioners who are seeing complex patients with psychiatrists for second opinions, according to Mou.

He stressed that Cerebral is building a better "patient-centric" experience that brings mental health care services to patients' homes via an app. Rather than requiring a patient with anxiety to leave their home, travel long distances and sit in a therapist's waiting room and then wait in line at a pharmacy, telehealth services are more convenient and prescribed medications can be delivered to their homes.

"That level of high-quality user experience is now more and more in demand, especially for behavioral health," he said.