Ketamine telehealth has been a wild ride these last few years. Every few months I give an update, and every time I do, things seem to change dramatically. For example, in just a few short weeks in February 2023, the situation went from “bad” to “good” (at least sort of) as it became clear that DEA would extend certain telehealth flexibilities beyond the COVID-19 pandemic. Today, I want to talk about a few of the more recent developments.
First though, a quick summary of the current law is in order. As I explained in my last summary in May 2023:
For some background, ketamine is a schedule III controlled substance under the federal Controlled Substances Act (CSA). The federal Ryan Haight Act (RHA) requires physicians to have an in-person consultation with a patient prior to prescribing controlled substances such as ketamine. During the COVID-19 public health emergency (PHE), this provision was suspended, leading to an explosion of ketamine telehealth services.
The PHE officially ended yesterday, May 11, 2023. The long-time anticipation was that the RHA requirements would kick back in. A few months ago however, DEA dropped a proposed rule that would have created a middle ground for prescription of certain controlled substances. I wrote about that proposed rule at length here, so I won’t recount it.
While the proposed rule would have been more expansive than the RHA, a lot of people weren’t exactly happy about it. DEA apparently received 38,369 comments. In a surprising turn of events, DEA decided to put things on ice and adopt a temporary rule that keeps the status quo for a period of six months. So DEA will essentially allow current flexibilities (there are some nuances I won’t get into here) until November 11, 2023. And for relationships established during the PHE or before November 11, 2023 per the rule, prescriptions may continue through November 11, 2024.
As you can probably guess based on the above, DEA’s temporary rule is still in place. But that doesn’t mean there haven’t been some noteworthy milestones or developments. So let’s dive in:
1. HIPAA is back
Back in April, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced that certain COVID-19 flexibilities would expire with respect to Health Insurance Portability and Accountability Act of 1996 (HIPAA). That didn’t all happen at once, and as OCR said:
OCR is providing a 90-calendar day transition period for covered health care providers to come into compliance with the HIPAA Rules with respect to their provision of telehealth. The transition period will be in effect beginning on May 12, 2023 and will expire at 11:59 p.m. on August 9, 2023. OCR will continue to exercise its enforcement discretion and will not impose penalties on covered health care providers for noncompliance with the HIPAA Rules that occurs in connection with the good faith provision of telehealth during the 90-calendar day transition period.
To be clear, HIPAA itself wasn’t waived during the COVID-19 PHE – but certain flexibilities were granted. The bottom line is that as of August 10, they will be gone. The effects of this are too complex to get into in this short post, but I will note that covered providers will need to ensure that they use HIPAA-compliant technology for ketamine telehealth sessions. This could be a big change for a lot of ketamine telehealth who may have used otherwise non-compliant tech.
2. DEA wants your thoughts on ketamine telehealth
On August 7, 2023, DEA published a notice of meeting for “public listening sessions.” The purpose of these sessions is for DEA:
to receive additional input concerning the practice of telemedicine with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. Specifically, DEA is inviting all interested persons, including medical practitioners, patients, pharmacy professionals, industry members, law enforcement, and other third parties to express their views at the listening sessions concerning the advisability of permitting telemedicine prescribing of certain controlled substances without any in-person medical evaluation at all, the availability and types of data that would be useful in detecting diversion of controlled substances via telemedicine that are either already reported or could be reported, and specific additional safeguards that could be placed around the prescribing of schedule II controlled substances via telemedicine.
The last clause is kind of important here, and we expect a lot of the discussion to focus on schedule II opioids that present much different risks from ketamine telehealth.
The listening sessions will take place on Tuesday, September 12, 2023, and Wednesday, September 13, 2023, from 9 a.m. to 5:30 p.m. They will be at DEA’s HQ in Arlington, VA, and importantly:
MEETING ATTENDANCE: Persons wishing to attend the listening sessions in person, space permitting, must complete and submit the attendance form available at DEA’s Diversion Control Division website, https://apps.deadiversion.usdoj.gov/ListeningSession, no later than August 21, 2023. There is no fee to submit the attendance form or to attend the listening sessions. In-person This document is scheduled to be published in the Federal Register on 08/07/2023 and available online at federalregister.gov/d/2023-16889, and ongovinfo.gov. Attendance requests will be granted via random lottery among those who have submitted timely attendance forms. The listening sessions will also be livestreamed online.
This is just a shorthand summary of the notice, so if you’re interested in attending or commenting, be sure to give it a good read and mark your calendars!
3. DEA special registry???
In the above notice, DEA further states that:
In addition, several hundred comments specifically raised the possibility of a separate Special Registration for those practitioners who seek to prescribe controlled substances without conducting an in-person medical evaluation of patients at all.
DEA is open to considering—for some controlled substances—implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all. DEA also observes that making permanent some telemedicine flexibilities on a routine and large-scale basis would potentially create a new framework for medicine that fundamentally expands access to controlled substances in a way that warrants a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time.
To that end, DEA issued a series of open-ended questions that it may use to evaluate the need for such a registry. If such a registry were created, it may allow registered physicians may be able to prescribe some controlled substances solely via telehealth. This is obviously a big deal, and though it’s a ways away, could spell some major changes for the ketamine telehealth industry.
Stay tuned to the Psychedelics Law Blog for more updates on the ketamine telehealth industry.