As the Drug Enforcement Administration (DEA) holds listening sessions this week for its proposed rule that rolls back Covid-19 flexibilities for the virtual prescribing of controlled substances, four mental health companies issued a letter Monday to the DEA laying out their recommendations.
The four companies are Talkiatry, Array Behavioral Care, Iris Telehealth and Quartet Health (which recently acquired innovaTel Telepsychiatry). They offer virtual psychiatry services, and while normally competitors, decided to band together to help patients maintain access to virtual prescribing of controlled substances, as well as to ensure their safety.
The DEA’s Covid-19 telemedicine flexibilities have allowed physicians to virtually prescribe controlled substances without an in-person visit. That is set to expire in November after the agency gave a six-month extension. Back in March, the DEA issued a proposed rule that would allow qualified providers to prescribe Schedule II and Schedule III-V medications via telehealth only after an in-person visit or after the patient was referred by a DEA-registered provider that had at least one in-person medical evaluation. Companies have been up at arms about this, especially tech-enabled companies that benefitted from the relaxed prescribing rules as did patients. The agency received 38,000 comments about the proposed rule.
“Under the proposed rules for telemedicine issued on March 1, 2023, many Americans who rely on telemedicine services will lose access to mental health, substance use disorder, and other healthcare services,” the companies said in the letter, which was shared with MedCity News.
The four companies urged that the DEA issue a new special registration process in addition to its previous proposal that would expand access to the virtual prescribing of controlled substances. This special registration process would allow qualified providers to virtually prescribe Schedule IIN non-narcotic, III, IV and V medications (which generally have less potential for abuse) without an in-person visit or referral. If a provider has a DEA registration, they would only need one special registration to prescribe controlled substances via telemedicine across the U.S.
The companies also proposed several guardrails to ensure patient safety with the special registration process. For example, providers must evaluate the patient every 90 days in order to prescribe controlled substances virtually, and Schedule IIN non-narcotics must be used for mental health reasons. The proposal also calls for data reporting from the provider and limits on Rx volume (with exemptions for hospitals and nonprofit organizations, as well as prescriptions for buprenorphine, which is used to treat opioid use disorder).
The DEA has said it would enact a special registration process since 2009 but has yet to do so. Geoffrey Boyce, founder of Array Behavioral Care, said he thinks the DEA will be open to the companies’ proposal, especially given that it extended the Covid-19 flexibilities after getting 38,000 comments on its proposed rule.
“I think the fact that they did not rush their proposed regulations into final form and actually said, ‘No, we’re going to pause and take these 38,000 comments that we got seriously’ … gives me hope that there is going to be receptivity,” Boyce said in an interview.
If a special registration process isn’t implemented, patients have the most to lose, said Robert Krayn, co-founder and CEO of Talkiatry.
“Sixty percent of counties in the U.S. don’t have a psychiatrist at all,” he said in an interview. “Even more than that don’t have a child or adolescent psychiatrist. The referral process is asking them to go and get an in-person visit by a primary care physician when it’s up to the standard of care for a psychiatrist. Many of them are going to have to leave work, they’re going to have to drive 45 minutes to see someone. It’s just adding to the stigma and the overall expenses that patients have to bear.”
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