The prescribing of controlled substances via telehealth companies has come under scrutiny for alleged deceptive practices. Online health companies have been cited for alleged improper prescribing of opioid and stimulant medication for patients purported to be suffering from a variety of conditions, but especially attention deficit-hyperactivity disorder (ADHD). Two mental health companies in particular -- Cerebral and Done -- have been singled out by the Department of Justice, and are reported to be targets of investigations by the Federal Trade Commission and Drug Enforcement Agency, respectively.
Federal law mandates that a prescription for a controlled substance issued through the internet (including telemedicine) must generally be predicated on an in-person medical evaluation. Regulations governing the online dispensing of controlled substances have been relaxed during the pandemic. However, the regulations may once again be enforced in light of the decreasing numbers of patients affected by the coronavirus and the pandemic's favorable prognosis.
Many of the new tele-mental health companies are small yet big-business minded and backed by mega investors. Globally there are nearly 900 mental health telemedicine companies. Many providers who work online for these companies often work independently from home with no professional liability insurance provided by the company. They are leaving a broken legacy system coupled with the promise of better pay and the excitement of a startup.
A telehealth "appointment" does not require a physical exam, vital signs, or neurological observation. Certain current and former employees claim they feel pressured to be fast and promptly submit an electronic prescription. Tele-mental health companies have been compared to fast-food establishments, and some have raised concerns about their potential to successfully treat patients at high risk of suicide or those suffering from other serious mental health conditions.
Case in point: Cerebral failed to identify that a patient who completed suicide while in treatment was, in fact, a minor. By Missouri law, Cerebral should have notified the teenager's parents about treatment, but their consent was never obtained. The parents did not find out their son was in treatment -- let alone suicidal -- until the day he died.
Meanwhile, the websites of certain tele-mental health companies paint a picture of serenity and tranquility, with faces of happy, smiling people. Several companies advertise free assessments, affordable "membership" plans, and ease of availability of appointments. They provide testimonials from highly satisfied clients claiming rapid improvement. From what I saw, however, statistical methods used to determine patient outcomes were never given. I wondered whether medical and educational information for consumers was reviewed by physicians, as is customary on well-established medical websites for the public.
Some companies have enlisted renowned psychiatrists and sports figures as spokespeople, advisers, and consultants. Among them, gymnast Simone Biles is Chief Impact Officer at Cerebral. Swimmer Michael Phelps teamed up with Talkspace.
When I combed through the web pages of several of these startup companies, I could not readily discern their key leaders or, in the case of Cerebral and Done, any mention of government probes apart from a comment by Cerebral's CEO that Cerebral has been the "target of news stories that provide a distorted view of our outstanding care."
In the spirit of full disclosure, I was interviewed by Cerebral and Done for part-time positions. At Cerebral, I was hired to supervise advanced practice providers (APPs), but I resigned in less than a month, before any supervision occurred. As advertised in Cerebral's job postings, psychiatrists supervise APPs by auditing their charts, along with other measures such as collaborating with the psychiatric mental health nurse practitioner team. I believe clinical consultations directly with APPs -- in person, by phone, or via secure video -- should be the predominant method of supervision.
I spoke with the executive leader of Done on a couple of occasions. She characterizes herself as a "builder." But because she has no medical background, she was considering hiring me as the medical director. However, I was told by an outside recruiting agency that Done was also pursuing other candidates. I asked to be withdrawn from consideration, not because I was afraid of competition, but because I believed the company lacked adequate infrastructure and was exclusively focused on treating patients with ADHD.
I have no axe to grind with either company. In fact, I'm aware of at least one study that showed use of telehealth services was associated with fewer opioid overdoses during the pandemic. However, companies must follow the proper procedures for prescribing controlled substances to patients or else stop prescribing them. (Cerebral disclosed in May that they would stop prescribing most controlled substances.)
Online mental health companies need to make a greater commitment to operating ethically and professionally. Their websites need to be more transparent about clinical and business practices. Important clinical information should not be qualified by asterisks or buried in the fine print of legal disclaimers.
Consumers should be aware that online mental health care is not designed for those with serious and persistent mental illnesses or those who experience frequent crises. It's telling that Cerebral provides non-company resources for individuals in emotional distress -- for example, the phone number for the National Suicide Prevention Lifeline -- and requires clients to hold them harmless for delays in evaluation due to "technical failures."
Treatment of ADHD with non-stimulant medication should be emphasized as an option for some individuals, and ADHD should not be the sole focus of treatment of online mental health care. Providers should be well-versed in the diagnosis and treatment of all major mental health disorders.
Celebrities should think twice about lending their names to mental health startups simply to increase the company's market visibility. All clinical information geared toward consumers should pass scientific muster: the information must be accurate, complete, and not misleading. Companies should make it known that claims of efficacy and positive outcomes reflect only clients who volunteer their experience and are, therefore, not valid statistical samples.
While there are clear indications to treat psychiatric and other disorders with controlled substances, I believe it is a responsible intervention to prevent or at least reduce the abuse of stimulant medications and opioid derivatives, especially when prescribed through telehealth platforms. It's too easy to get these medications online by giving false information to prescribers.
We must not compound the opioid crisis by supporting or working for telehealth companies that seem interested in pushing pills for profits at the expense of patient safety. Let's not lose sight of what it means to provide genuinely ethical care.
Arthur Lazarus, MD, MBA, is a member of the Physician Leadership Journal editorial board and an adjunct professor of psychiatry at the Lewis Katz School of Medicine at Temple University in Philadelphia.
https://www.medpagetoday.com/opinion/second-opinions/101041