The article New Rules for Ketamine Telehealth was originally published on Microdose.
Ketamine therapy and ketamine telehealth have been important components of these early days of the psychedelic renaissance. Ketamine, being the only medicine currently approved by the FDA, is leading the way in giving patients access to therapies and in de-stigmatizing psychedelic therapy.
These therapies were given a big boost during the pandemic. As summarized in the article below:
…a federal law known as the Ryan Haight Act requires physicians to have an in-person consultation with a patient before prescribing controlled substances. The federal government waived that requirement during the PHE declaration. This allowed entrepreneurial ketamine telehealth clinics and their physicians to enter into patient relationships without in-person consults.
During the last few years, ketamine telehealth has flourished, with companies expanding their operations (and perhaps sometimes overlooking the potential for addiction). It’s been a boon for patient access and firms attempting to get some psychedelic revenues dollars, but that all seems set to change.
As laid out in this informative Twitter sequence by the folks at Psychedelic Alpha, the Biden administration’s ending of Covid emergency measures has led to changes in telehealth requirements.
See below for an explanation of the new measures and scroll down for some more context from the Harris Briken Psychedelics Law Blog.
Biden’s Telehealth Prescription Plan: Ketamine to Be Limited to 30 Day Supply
Doctors will only be able to remotely prescribe a 30-day supply of some scheduled drugs, including ketamine.
Additional prescriptions thereafter (i.e., refills) will require an in-person consultation. pic.twitter.com/UkE5VQo536
— Psychedelic Alpha (@Psyched_Alpha) February 25, 2023
DEA Announcement: https://t.co/yXV3rVOPdY
Simple overview of the proposed new rules: pic.twitter.com/NnjFYSgB7I
— Psychedelic Alpha (@Psyched_Alpha) February 25, 2023
This piece was originally published on the Harris Briken Psychedelics Law Blog and is re-published here with permission
Bad News for Ketamine Telehealth
Earlier this week, President Joe Biden’s administration made an announcement that signals potential bad news for the ketamine telehealth industry.
Effective May 11, 2023, the federal COVID-19 public health emergency (PHE) declaration will end. This is likely to plunge the entire ketamine telehealth industry into chaos in the coming months.
If you are unfamiliar with the ketamine telehealth issues relative to the ongoing COVID-19 PHE declaration, I suggest you read these posts of ours:
- Ketamine, Internet Prescribing, and Telehealth– Say What?
- Ketamine Telehealth: An Update
- Ketamine Telehealth and the Looming Public Health Emergency Deadline
To summarize briefly, a federal law known as the Ryan Haight Act requires physicians to have an in-person consultation with a patient before prescribing controlled substances. The federal government waived that requirement during the PHE declaration. This allowed entrepreneurial ketamine telehealth clinics and their physicians to enter into patient relationships without in-person consults.
Now that the PHE declaration is ending, and unless Congress modifies the Ryan Haight Act (more on that below), the prior in-person consultation requirement returns for new patients. Less clear is how the federal government (and don’t forget states!) will handle physician-patient relationships developed during the PHE declaration solely by telehealth. Nobody really knows yet. This uncertainty is bad news for anyone in the ketamine telehealth industry.
Over the coming months, we are likely to hear more from federal and state regulators on these points. Biden (according to at least one report) intends to use his authority to extend certain telehealth protections:
The Biden administration and Congress previously agreed to extend waivers for telehealth programs beyond the public health emergency. Stacey Hughes, executive vice president of government relations and public policy for the American Hospital Association, said hospitals are hoping to see permanent reforms relating to telehealth and hospital-at-home programs.
As mentioned above, there have been efforts for a significant time to change federal laws and allow prescriptions via remote means. These efforts have by no means been limited to ketamine telehealth advocates – in fact, many advocates have pushed for these changes to allow remote medical services to people in places where they may not have access to psychotherapy or other forms of medical care.
And of course, there is always state law. States impose wildly different requirements on medical providers (as an aside, check out our ketamine state map to see ketamine laws by state). Even if federal law changes, state law will still differ across the map.
For the time being, things remain up in the air. There is bipartisan support for change to federal law, but as we know Congress has for very long been completely unable to act quickly. A shakeup is likely in the ketamine telehealth industry in the coming months. We expect some businesses to pivot away from ketamine telehealth entirely, and others to at least continue to offer telehealth services without in-person consults to patient relationships established during the PHE.
Stay tuned to the Psychedelics Law Blog for more updates on ketamine telehealth.