When the founders of Cerebral launched a new digital mental health platform in January 2020, there was already a national shortage of psychiatrists that led to months-long wait times for appointments. Then the pandemic sent levels of depression, anxiety and other mental illnesses soaring, made it harder to get prescriptions filled and led to policy changes that liberalized the use of telehealth services for prescribing controlled substances.
For Cerebral, it was rocket fuel for the rapid growth of a company that wanted to make a business of quickly attending to mental health needs – especially the demand for psychiatric medications. Cerebral’s pitch: It could connect users to providers for a consultation within days, offer treatment for anxiety, depression and attention deficit hyperactivity disorder (ADHD), and – with a few taps on a smartphone – get prescriptions delivered to their doors. Two years later, the company has treated 400,000 patients and conducted some 1.8 million telehealth visits.
But Cerebral’s meteoric growth was matched with an equal freefall that has left some patients scrambling to fill their prescriptions. Over the past three months, the company has become the target of a Department of Justice investigation for potential violations of the Controlled Substances Act, a lawsuit from one of its former executives alleging illegal business and prescribing practices, and an investigation by the Federal Trade Commission into its marketing.
Scrambling for alternatives
Cerebral announced in late May it would taper patients off controlled substance prescriptions like Adderall by October, but before it could do so, CVS, Walmart and Truepill pharmacies stopped refilling the company’s prescriptions. Now, patients who rely on the company for their medications are searching for alternative providers before their last refills run out.
Patients told MindSite News they were rationing their remaining pills. Many lack insurance, and are not sure they’ll still be able to receive affordable care and medication for their ADHD. Others have given in and paid more. Since ADHD is diagnosed less often in girls and women, some female patients are worried that even if they do find an alternative provider, they won’t get the same diagnosis.
In an interview, Cerebral CEO David Mou told MindSite News the company is helping patients currently prescribed controlled substances by Cerebral to instead get them from in-person providers or to switch to medications that are not controlled. The company is also “doubling down and tripling down on clinical quality,” and wants to shift to a business model focused on “value-based care,” in which outcomes are closely tracked and insurance companies reimburse them based on the quality of care. (See full interview here.)
Juan Carlos Castaneda signed up for a monthly subscription with Cerebral in January after spending a few weeks searching for traditional providers without finding any he could see in less than two months. Castaneda suspected he might have ADHD, and a Cerebral provider confirmed that diagnosis and prescribed Adderall that same day. The difference in his mental state “was like night and day,” he said.
“My brain my whole life has been going a hundred miles an hour,” he told MindSite News. “The day I took it, it was like a switch just got turned off. I could focus. There wasn’t all the noise in my head.”
Castaneda ran out of medication at the end of June, and his refill was blocked by CVS and Rite Aid. After hearing that he wouldn’t be able to get controlled substances from Cerebral in late May, he looked for alternative providers but faced the same psychiatrist backlog that drew him to Cerebral in the first place. The earliest appointment he could find was at the end of July. After a week without medication, he was able to get Walgreens to refill his Cerebral prescription
“There are certainly many pharmacies that still fill our medication,” Mou said. “We’re educating our clinicians to make sure they are sending the scripts to the right pharmacies.”
The ability to prescribe controlled substances without an in-person consultation was intended to be a temporary pandemic provision. In January 2020, the same month Cerebral launched, the Drug Enforcement Agency (DEA) suspended a requirement set out by the Ryan Haight Online Pharmacy Consumer Protection Act, a 2008 law that placed limits on prescriptions of controlled substances due to their potential for abuse. The suspension of the rule allowed certain controlled substances to be prescribed via telehealth without an in-office evaluation.
Telehealth prescribing of controlled substances in limbo
That enforcement delay has been extended every 90 days as the federal government continues to deem the U.S. to be in a public health emergency. It was set to expire on July 15, but was extended again to five months after whenever the Biden Administration declares the pandemic public health emergency over. That means the flexibility to prescribe via telehealth will likely last through 2022. Mou said Cerebral’s decision to stop prescribing controlled substances on May 20 was a result of the impending expiration.
Cerebral wasn’t the only startup that took advantage of the pandemic exception. Startups Done Health and Ahead also started prescribing ADHD medication via telehealth, but like Cerebral, the move was short-lived. Ahead shut down in April and Done prescriptions are also being blocked by CVS and Walmart.
In a June letter to the DEA, Rep. Gerald Connolly (D-VA), chair of the House Subcommittee on Government Operations, wrote that Cerebral and other online mental health providers were “abusing” the exception. But he also wrote that he “strongly support[s] the continued use of telehealth by legitimate and responsible providers.”
State legislatures and physicians have urged that the telehealth exception be made permanent, as have Sens. Rob Portman (D-OH), Sheldon Whitehouse (D-RI) and 72 organizations, including the American Psychiatric Association, which argued that it “only results in reduced access to care.”
Still, the future of telehealth prescribing of controlled substances – including stimulants for ADHD – is far from clear.
“It’s frustrating to think about all the people that this helped that might have to go cold turkey off of their medication now,” said Dixie Cochrane, who has ADHD and has been using Cerebral since 2020. She switched from Betterhelp, an app that offers virtual therapy but no medication, because of Cerebral’s prescription service.
CVS and Walmart began blocking or delaying Cerebral prescriptions in the last year, the Wall Street Journal reported, even before deciding to stop filling them altogether. Some Cerebral patients report that Walgreens also wouldn’t fill their stimulant prescriptions.
Walgreens said in a statement that it considers Cerebral prescriptions on a case-by-case basis to evaluate the legitimacy of prescriptions, “which includes verifying that a relationship between the patient and the prescriber exists,” Walgreens spokesperson Fraser Engerman wrote. “If red flags exist on a prescription that cannot be resolved, our pharmacists will refuse to fill the prescription.”
Risk of withdrawal
This isn’t the first time Cerebral patients have faced difficulties.
Soraya Karimi canceled her subscription and switched to a local provider in April after her Cerebral provider said the company would no longer prescribe quetiapine, an antipsychotic she’d been taking off-label as a sleep aid. The provider planned to stop the prescription rather than taper her off the medication, Karimi said, as is typically recommended.
“I think risking withdrawal symptoms with this method is absolutely appalling,” she said. “I had to really ration my medication, like cut it up into eighths and take a little bit every day.”
MaryBeth Zmuda started getting antidepressants from Cerebral early in the pandemic. Soon, she started setting an alert on her phone every month to remind her to start relentlessly messaging her care provider. Otherwise, she had learned, her refill might not reach her in time. Still, she felt stuck.
If she left Cerebral, “I’m going to have to find another doctor, go through the whole process again, and wait for somebody to decide whether they think that I should be on this medication,” she said in a March interview. “I don’t want to take the chance because the medication is helping me.”
Zmuda finally canceled her Cerebral subscription in June after her general practitioner offered to prescribe the antidepressant.
Grappling with staff turnover
At least 84 Cerebral patients reported facing difficulty accessing their prescriptions on the Apple App Store from December 2020 to June 2022, according to a MindSite News analysis of the app’s one- and two-star reviews. Some said the delays caused medication lapses that led to withdrawal symptoms and even suicidal ideation.
Cerebral also has been grappling with high turnover. Patients reported cycling through multiple providers, causing gaps in their regularly scheduled appointments and sometimes contributing to medication delays. One former employee who worked as a phone coordinator but requested to remain anonymous to protect him from legal liability said he went through internal documents to find records of at least 1,700 prescribers that no longer work with the company. There are 1,596 prescribers currently listed on Cerebral’s website, about 100 fewer than there were in mid-June.
In April, a Cerebral spokesperson wrote that the company was “continuing to hire and grow its team.” But now, entangled in federal investigations and with its prescription powers hamstrung, the company started laying off employees. Mou said the layoffs are the result of a shift to “sustainable growth and focusing on reducing our scope.”
The former phone coordinator, who worked at Cerebral from November 2021 to March 2022, told MindSite News he estimated that 70% of the calls he took were related to Adderall prescription refills.
“Because [patients] couldn’t get that appointment with the prescriber, where the prescriber would approve the refill, you would have people running out of medication,” he said. “I tried to help people with that by calling pharmacies, but the prescriber had to either approve it or do something. A lot of times you couldn’t get a hold of the prescribers.”
In its rush to grow, Cerebral booked appointments for hundreds of patients, some of whom had conditions too complex for providers’ limited medical training and experience, Business Insider reported. Some patients with a history of addiction were prescribed controlled substances, some had multiple prescriptions for the same medication, and others expressed concern after being prescribed so quickly.
Mou said the incident reports cited by Business Insider were not representative of Cerebral’s quality of care, and that “looking at our clinical outcomes is really important in aggregate.”
“We have really good outcomes in terms of depression and anxiety,” Mou said. Spokesperson Dan Childs said company data shows a 50% drop in suicidal thoughts among patients who reported them during intake.
But now, patients like Dixie Cochrane are searching for alternatives to stay on their medication. She’s been using Cerebral for two years, and would have stayed if it weren’t for her challenges getting medication.
“Finding somebody who has sliding scale payments, finding people who are comfortable with adult ADHD in women is actually harder than you might think,” she said.
Cochrane recently switched from CVS to a local independent pharmacy to get her prescription refilled. She doesn’t have insurance, which is part of the reason she chose Cerebral.
“The service is for people like me, it’s for people who maybe don’t have insurance but can pay 100 bucks a month out of pocket to get the help they need,” she said. “It is just immensely frustrating knowing that those are the people who are going to be the most affected. It’s not going to be the people who can easily get a psychiatrist with their insurance.”
Cerebral’s basic prescription service, which include monthly sessions with a prescriber, costs $85 per month. Combining that with weekly sessions with a licensed therapist ups the cost to $325 per month. The average income of Cerebral users is below the national average, Mou said, and two-thirds have never before received mental health care.
Jenna Lefever, who lives in Washington state, is also uninsured. After the company announced it would stop prescribing controlled substances, her Cerebral provider switched her medication from Adderall to a non-controlled, non-stimulant, but Lefever found it less effective. She left Cerebral in June when she found a new in-person provider on ZocDoc.
Like Cochrane, Lefever was drawn to Cerebral because she found it more affordable than other providers. And while she likes her ZocDoc prescriber, she’s also paying more.
Cerebral patients who sign up for the company’s less expensive prescription plan meet with a nurse practitioner or doctor once a month. The initial call is 30 minutes long, but after that, meetings can be as short as 15 minutes – another source of criticism.
“ADHD is something that I believe takes longer than just 30 minutes or a single visit to diagnose the initial time,” said Steve North, an adolescent medicine specialist who founded a school-based telemedicine program. “A history of trauma can look like ADHD. Anxiety can look like ADHD. A substance use disorder can look like ADHD.”
North said that ADHD patients turning away from Cerebral can start with their family physician in their search for alternative providers, and suggested chadd.org for resources on managing without medication. For those without insurance, he suggested visiting a federally qualified health center, which provides care on a sliding scale.
For patients who find an alternative provider, “taking the time to make sure that it’s an appropriate diagnosis is essential,” North said.
Incentive to prescribe?
Cerebral practitioners told the Wall Street Journal and Bloomberg they felt pressured to prescribe Adderall. The lawsuit filed by Matthew Truebe, a former vice president for product and engineering, alleged that Cerebral tracked the retention rate of ADHD patients who were prescribed stimulants and – when data showed they were more likely to keep their subscriptions – advised prescribers to find ways to prescribe more stimulants. Truebe claimed the company established a goal of prescribing stimulants to 100% of ADHD patients – a charge Mou flatly denies.
“There are absolutely no incentives for diagnoses or for what percentage of your patients are on a controlled substance,” he said. “I’ve sent out repeated emails where I actually say, ‘Don’t rush to a diagnosis. If it’s not enough time, schedule a follow-up appointment.’”
An April 2021 report by Cerebral said that, overall, 94% of patients being prescribed medications had their prescription refilled – a metric the company referred to as an “adherence rate.”
At one point, ADHD prescribing constituted 20% of Cerebral’s business, the Wall Street Journal reported. Mou said halting the prescribing of controlled substances has not greatly reduced revenue, although he declined to provide numbers. Most patients have depression or anxiety, he said, which are largely treated without controlled substances.
As Cerebral grapples with investigations and lawsuits, Mou said the company will continue improving quality by taking advantage of its unique assets, including the fact that it has created its own proprietary electronic health record. This gives the company extensive data on all of its patients, allowing its clinicians to better predict the type of care they need, he said.
Some patients aren’t waiting around for those improvements.
“I hope a better system can be worked out,” said Lefever, the patient who left the Cerebral after being transitioned to a non-stimulant. “It’s good for people to have affordable access from the comfort of their home. I just hope that everything is above board moving forward.”
Disclosure: Tom Insel, a co-founder and donor to MindSite News, is an advisor to Cerebral CEO David Mou. Insel was not involved in this story.