By Vincent Joralemon
In my last post, I discussed the rise of psychedelic lobbying — how companies with vested economic interests in psychedelics have applied pressure to shape regulations that favor their business models.
One such initiative — the ketamine therapy industry’s push to extend the COVID-era telemedicine flexibilities for prescriptions of controlled substances — highlights how sophisticated these campaigns can be, and how their impact stretches beyond the psychedelic industry.
Off-Label Ketamine Prescriptions
First, a bit of background. Ketamine is unique among psychedelics because it is a Schedule III narcotic, whereas the other “classical” psychedelics and MDMA are all Schedule I.[1] This is because ketamine was developed, and is still widely used, as a human anesthetic. So, physicians can also prescribe it “off label” for depression, anxiety, or any other indication they think it may alleviate.
This might seem weird, and sometimes leads to some suspect ketamine prescriptions. However, the U.S. grants doctors broad discretion to prescribe medications off-label — so if a clinician believes ketamine will alleviate a patient’s depression or anxiety, they can prescribe it relatively easily.
Note: FDA approval for at least one indication is necessary for other “off-label” uses of the drug. You need one FDA approval to open the door to other off-label uses. Remember — no other psychedelic is FDA-approved (yet). So, while there are clinics, retreats, and telehealth providers that legally provide ketamine in the U.S., none can (legally) provide psilocybin, LSD, or MDMA (yet).
Ketamine Telehealth
This brings us to the telehealth extension. In response to the COVID pandemic, the federal government eased some of the Ryan Haight Act restrictions on telehealth services — making it easier to provide medications to patients without speaking (in person) to a physician. Several ketamine-focused companies used this to prescribe the drug off-label to treat depression and anxiety in individuals from their own homes. Again, they could do this because:
- Ketamine is FDA-approved as an anesthetic;
- Drugs with one approved indication can be prescribed off-label for other indications; and
- The Ryan Haight Act exemptions allowed for Schedules II-V controlled substances to be prescribed over telehealth, without a prior in-person examination.
Yet, as the COVID emergency waned and bad press about unscrupulous telehealth practices emerged, the Biden Administration was set to let the waiver expire on May 11, 2023. News of this caused a minor crisis in the at-home ketamine telehealth industry. In November 2022, Peak Health Global, a telehealth psychedelic therapy startup, announced they were closing up shop in response to the expected rule changes. Others declared they were also throwing in the towel, and the outlook across the industry looked bleak.
Lobbying to the Rescue
Still, the ketamine telehealth industry would not go down without a fight. Before the Ryan Haight extensions expired, one of these companies engaged in a robust campaign to maintain the extension. The company, Mindbloom, hired lobbying firm Alpine Group Partners to extend the lifted restrictions. They even enlisted former Republican U.S. Representative Greg Walden, who once led the House Energy and Commerce Committee. This was clever — although some Republicans have shown increasing support for psychedelics, the party overall has been hesitant about expanded psychedelic access. Mindbloom runs a relatively tighter operation in terms of oversight and patient support than a lot of the more controversial providers — so it was likely easier for them to point to their own model as a fairly prudent use of the telehealth exemption.
And… it worked! DEA and HHS extended the telehealth waivers to at least late 2024. But note — this was not a ketamine-based development; it extended all of the COVID-era Ryan Haight Act exemptions. This meant that any Schedule II-V controlled substances[2] remained eligible for telehealth prescriptions, including drugs like Xanax, Valium, Klonopin, Adderall, Dexedrine, Ritalin, buprenorphine, and… ketamine!
This underscores another intriguing element of psychedelic advocacy: lobbying initiatives in this domain transcend the psychedelic industry. The telemedicine extension is not just for psychedelics; easing these restrictions means relaxing them for other controlled substances as well. And, the waivers also allow physicians to bill Medicare regardless of where patients are located and prescribe medications with audio-only calls.
Leveraging Public Opinion to Serve Public Health
Again, this is not necessarily problematic! It makes sense for a company like Mindbloom to lobby for this extension. Their whole model operates on the ability to prescribe ketamine over video calls, and because of that, they can charge much less than on-site ketamine therapy clinics. Traditional psychedelic therapy isn’t cheap, so this extension likely means that access is maintained for many people who otherwise couldn’t afford the in-person alternative.
Still, there are a lot of concerns about a lack of oversight and the potential for patient harm through telehealth prescriptions. With the news of Matthew Perry’s death from the “acute effects of ketamine” at his home, risks in this space are front of mind for many.
In response, policymakers will need to continue to conduct balanced cost-benefit analyses based on the spectrum of public influence campaigns:
- If companies with a vested interest want to lobby for a particular rule extension, they should do so. They not only have an economic stake in the outcome, but also have intimate familiarity with the industry. Why not leverage that expertise to make the system better?
- If concerned citizens or health organizations want to push against these initiatives, they also should do so. DEA and HHS have a public “request for comment” whenever things like the telehealth extensions are up for consideration. Why not exercise your right to push for policies that align with your interests?
These regulations exist to benefit the public interest and achieve quality control within our health care system, not just to serve the needs of individual citizens or businesses. Gathering information from these parties is fine, but the key is to ensure that policymakers have the autonomy to balance these considerations independently, avoiding undue influence from any single entity.
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[1] Note: I consider ketamine a psychedelic, as do others, but there are substantial debates about this categorization.
[2] Okay, not actually any controlled substances. For example — some FDA-approved drugs come with a Risk Evaluation Mitigation Strategy (REMS) that includes added restrictions. For example, Spravato, Janssen Pharmaceutical’s intranasal S-ketamine product, comes with a REMS that mandates the product can only be given in an approved facility. So, Spravato cannot be prescribed via telehealth — but regular ketamine can!
