DEA investigates telehealth provider Done for Adderall prescribing practices: media report

U.S. Drug Enforcement Administration (DEA) agents have begun investigating digital therapeutics company Done Global Inc.’s practices for prescribing controlled substances, The Wall Street Journal reported.

The outlet reviewed internal documents and spoke with people familiar with the inquiries in recent weeks. The DEA declined to comment. Done is a membership-based platform that connects patients seeking treatment for attention-deficit hyperactivity disorder (ADHD) with qualified clinicians. Federal authorities have shown growing interest in telehealth companies that prescribe stimulants like Adderall for treatment of ADHD. Done’s primary competitor, Cerebral Inc., received a grand jury subpoena from the Justice Department for “possible violations” of the Controlled Substances Act in May.

“Done has not received any notifications from the Drug Enforcement Agency, Department of Justice or any other federal agency regarding an investigation,” wrote a spokesperson for Done Global Inc. in an email to Fierce Healthcare. “Any reporting to the contrary would be false and inaccurate. Done is committed to providing high-quality psychiatric chronic care management to our members while complying with all applicable laws and regulations.”

The Controlled Substances Act regulates the distribution of potentially addictive medicines with OxyCotin in the same category of Adderall. Cerebral ceased prescribing Adderall for new patients following the subpoena and said it planned to fully cooperate with the investigation.

Done clinicians recently described feeling pressured to prescribe stimulants, the WSJ reported in March. Clinicians said the company’s 30-minute video evaluations were insufficient for an ADHD diagnosis. Done denied the implications, saying they do not pressure clinicians to write prescriptions but provide a platform for treatment.  

“Clinicians on the Done platform evaluate patients and make their own clinical determination on treatment for the patient, including whether to refer patients who would benefit from therapy treatment to Done's partners who work with therapists specializing in CBT (cognitive behavior therapy),” a Done spokesperson wrote. “Clinicians are not employees nor contractors with Done. Clinical operations are managed by separate independent medical groups headed by board-certified physicians.”

Clinicians may always schedule additional video or in-person appointments before completing a patient assessment, according to Done. The telehealth company said any suspicious prescription history is sent to clinical leadership for review.

The company made headlines this August when a Los Angeles man with a history of drug abuse relapsed after a Done clinician prescribed him Adderall. The man later died of a drug overdose with the toxicology report citing “acute opiate and cocaine intoxication” as the cause of death. The case prompted public concerns regarding how clinicians using the Done platform consider the history of addiction in its tens of thousands of patients before prescribing a medication.

Done has responded to various allegations that it provides a telehealth platform to enable treatment and does not prescribe any medications.  

“The clinician and the patient have a face-to-face conversation that is facilitated by our platform,” a Done spokesperson wrote. “The clinical decision process by the clinician is the same as if that individual was sitting across the desk in an office. There is no difference in the judgment process of professional clinicians treating their patients in-person or via a telehelath platform just as there are no differences in judgment about how other physicians treat their patients whether they are caring for them in-person or virtually.”

Walmart and CVS Health ceased filling prescriptions for controlled substances issued by Cerebral and Done in May, citing concerns regarding prescribing practices of telehealth platforms. A Done representative said the platform is working to aid patients in filling their prescriptions and has “resolved most causes.”

In response to the growing pandemic and stay-at-home orders, the DEA loosened remote prescribing restrictions of Schedule II through Schedule V controlled substances in January 2020. The policy shift weakened the Ryan Haight Online Pharmacy Consumer Protection Act, which previously stated that an in-person examination was required for the prescription of a controlled substance, a requirement set to return at the end of the public health emergency.

Legislators have urged the DEA and the Department of Health and Human Services to extend the exemption, nodding to public health benefiting from the technology. Recent research has shown a decrease in opioid overdoses in patients who received opioid use disorder telehealth care in conjunction with medications for opioid use disorder during the pandemic.

For those in need of drug addiction help, the National Drug Helpline can be reached at (844) 289-0879.