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Tele-Ketamine: The end of an Era?
In a recent interview with The Microdose, Raquel Bennett, the founder of the Ketamine Research Institute and an expert on the therapeutic use—and misuse—of ketamine, offered a useful metaphor through which to view this burgeoning psychedelic field:
“There’s a paradox in what’s happening in the field right now: there’s expansion and contraction.
I’m thinking about breath — that continuous ebb and flow of contraction and expansion — and how the whole universe is expanding and contracting at every moment.
In ketamine, the expansion is the need to increase access to care and services to people who need them. The contraction is agreeing on some guidelines for clinicians to keep people safe. How do we do those things simultaneously?”
This dynamic of expansion and contraction also captures the recent news from Down Under, in which medical grade MDMA and Psilocybin will be rescheduled for their use in healthcare settings.
At first glance, such a watershed moment might appear to open the floodgates for the widespread deployment of Psychedelic Assisted Therapy (expansion) until one considers the built-in, precautionary restrictionsthat will make access extremely limited (contraction).
A derivative of this expansion-contraction dynamic is that every expansionary event—like significant scientific findings, high-profile policy reform efforts, and newsworthy business developments—activates the news media and public discourse in such a way as to normalize—and inadvertently advertise—psychedelics as potential treatments for an array of mental health conditions.
And the paradox is that most organizations, institutions, and developments whose mere presence are indirectly—or directly—pointing to the therapeutic use of psychedelics are unable to meet the demand they generate—except for international retreats and ketamine providers
Amidst a mental health epidemic, the effect is that more and more people are entertaining the idea of psychedelic therapy—and many (most?) have financial constraints that leave them with two basic options:
Break the law
Telehealth-prescribed at-home ketamine.
The Telehealth Era
Before the Covid pandemic prescribing Scheduled substances like Adderall for ADHD, buprenorphine for opioid use disorder, or ketamine for depression required an in-person evaluation.
The in-person requirement was part of The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (2008!).
It was meant to regulate the then-nascent practice of prescribing controlled substances through telemedicine and specifically to prevent the diversion to illegal markets.
However, lockdowns in the early days of the Covid-19 pandemic prompted the DEA to waive the requirement for an initial in-person visit, thereby allowing patients to receive controlled substances through telemedicine (emphasis added) more easily:
"for the duration of the public health emergency, a practitioner may prescribe a controlled substance to a new patient via telemedicine—using a real-time, two-way, interactive audio-visual communication—without first conducting an in-person examination."
As a result, several companies began virtual evaluation, prescribing, and mail-order delivery of ketamine for patients to self-administer at home, including Mindbloom, Nuelife, Curio, KetaMD, Choose Ketamine, Joyous, Innerwell, and Wondermed.
On the one hand, this model creates a more affordable route to a potentially beneficial—and FDA-approved—compound and, for many, a preferred setting: their home.
On the other, the nature of the ketamine experience and addiction potential combined with the fiduciary obligations of a venture-backed business model creates mismatched incentives that may favor financial returns ahead of the comprehensive evaluation, psychotherapeutic support, and oversight of patients’ safety.
But with the Biden administration declaring that the Public Health Emergency will end on May 11, 2023, and with it presumably, the waiver that disbanded with the in-person evaluation requirement, many assume that telehealth prescribing of ketamine will go too.
But not so fast?
Déjà vu all over again
As far back as 2018, telemedicine advocates had made progress in overturning the in-person visit requirement, as evidenced by a congressional attempt to amend the federal Ryan Haight Act through the Improving Access to Remote Behavioral Health Treatment Act and the Special Registration for Telemedicine Clarification Act (emphasis added).
From a 2018 article from Healthcare consultancy Foley & Lardner:
“Congress simultaneously released a companion discussion bill titled the “Special Registration for Telemedicine Clarification Act”… This special registration would allow practitioners to use telemedicine to prescribe controlled substances without the per se in-person exam.”
More recently, several stakeholders—including The American Psychiatric Association, American Telemedicine Association, and American Medical Association—petitioned the DEA and HHS to make the Covid-era waiver permanent:
Specifically, we believe that the in-person evaluation prior to prescribing controlled substances via telemedicine only results in reduced access to care and does not enhance the DEA’s ability to do its job of limiting drug diversion or pursuing illegal actors.
…the experience during the pandemic which has shown increased access to necessary care when the patient is able to use telemedicine in their home or other location. While the Ryan Haight Act was intended to enhance DEA’s ability to pursue illegal online drug sellers, this limitation only results in less access to legitimate health care providers and does not give DEA additional tools to go after bad actors.
And according to a recent article by attorneys Roger A. Cohen and Simone Otenaike of the Goodwin Law Group, DEA was tasked by congress to amend the Ryan Haight Act in 2018:
“In 2018, the Special Registration for Telemedicine Act of 2018 was enacted, which required the Drug Enforcement Administration (DEA) to activate a special registration, which would allow physicians and nurse practitioners to prescribe controlled substances via telemedicine without an in-person exam. The law mandated the DEA to promulgate the regulations before a deadline of October 25, 2019 but the DEA never completed the task.”
So despite the end of the Public Health Emergency, which will likely re-instate the in-person visit requirement before prescribing scheduled substances, we shouldn’t expect tele-ketamine to go away but adapt to the new precaution.
In other words, after an unprecedented period of expansion, a potential return to “normal” would impose a—perhaps industry-saving(?)—force of contraction.
Headlines and Further Reading
Precautions include limiting the number of Authorized Prescribers (and a stringent authorization process) and limiting the treatment population to a small number of treatment-resistant cases of PTSD and Depression.