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Psychedelic Bulletin #131: Study Turns Understanding of Psychedelic-Induced Neuroplasticity Inside Out; EU Regulators Show Interest in Psychedelics; What Next for At-Home Ketamine Therapy?

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As regular readers will know, ketamine telehealth companies are able to prescribe the scheduled substance via telemedicine thanks to a COVID-era waiver to the Ryan Haight Act. Given that the Biden Administration will bring the public health emergency to a close on May 11, 2023, this waiver is set to expire, meaning that the virtual prescribing of scheduled substances like ketamine and ritalin will once again be prohibited. Instead, an in-person consultation will once again be required.

While those who are already clients of a ketamine telehealth company are likely to be grandfathered in, the regulatory uncertainty is being felt at a number of providers that Psychedelic Alpha has spoken to. Last November, Peak became one of the first casualties of the anticipated changes, announcing that it would cease onboarding new clients, and has sunsetted its services for existing customers.

There are various efforts underway to lobby the DEA. These include calls for the agency to introduce a pathway that allows for the prescribing of controlled substances via telemedicine via a telemedicine special registration rule.

It’s worth noting that we’re talking about federal regs here. While states do have some autonomy, the most important decisions will come from agencies like the DEA, which is expected to announce proposals pertaining to the future of telemedicine soon.

Presumably, regulators will look to find a middle ground between permitting the maintenance and expansion of certain telehealth services that improved access to healthcare during the public health emergency, while tightening up its somewhat laissez faire approach that led to perceived externalities, such as capitalising on perverse incentives to prescribe scheduled substances at significant rates (à la Cerebral – see below).

Whether at-home ketamine will satisfy Goldilocks—or, DEA’s Anne Milgram—is yet to be seen.


See our earlier coverage of this topic for more:

(Before it was on most of our radars, journalist Shayla Love was reporting on the matter back in November 2021.)Our coverage of SF-based mental health startup Cerebral’s DOJ investigation for potential violations of the Controlled Substance Act was titled, Mail-Order Ketamine Providers May Come Under Increased Scrutiny. Cerebral, which was very much in vogue after raising a $300m Series C with a $4.8bn valuation, was (among other services) prescribing a significant amount of Adderall via telemedicine. Just as former employees became increasingly critical of the company’s prescribing practices, regulatory scrutiny heated up, culminating in a DEA probe and a Grand Dury subpoena. “This increased scrutiny could have significant repercussions for other companies seeking to prescribe controlled substances remotely, including the growing crop of ketamine telemedicine companies”, we wrote.(May 2022)As Innerwell launched its at-home ketamine-assisted therapy offering hot off the heels off Nue Life Health’s $23m Series A, we sought to temper the “booming” hype around the segment. “Journalists like Shayla Love […] are exposing shortcomings in existing providers, while researchers like Elias Dakwar are casting a critical eye on the marketing and operations of many of these ketamine clinics.” (June 2022)

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