Great minds think alike! Clearly this is top of mind for us psychiatrists. My husband's Frontier Psychiatrists substack from today reaches the same conclusion after he had a sobering conversation with the DEA on their impression the PHE is already over in their minds and after we got the communication from PRMS, our malpractice carrier, on this stance. I do think we will see the micro-office-as-a-service plays cropping up and use of the loophole that patients can go to one of those offices and Zoom to their clinician located remotely but licensed in that state to get around the Ryan Haight rule and DEA expectation. I just don't see the DEA moving quickly to modify their position, especially not with all the ADHD and ketamine telehealth only plays that have cropped up when they turned a blind eye during Covid .
Totally agreed. This will likely turn out to be an unexpected moat around D2C digital mental health companies/models that don’t Rx controlled substances and are cash pay only. Who would’ve thought!
This was a great read. I'm from the IT side of things of Telemedicine. I knew there were restrictions based on what state the patient was physically located in, but I didn't know the reasoning. Looking forward to reading more!
There are 150 years of history of harm in the name of help. 100-Billion licit opioid pills shipped jump-started 100K preventable, yearly overdose deaths, yet they are labeled "the opioid problem" like a footnote in venture pitch decks as if reporting a software bug. The digitization of prescribing "at scale", may work for viagra and rogaine (over HIMS). Benzos, gabapentin, and the like were being over-prescribed before covid and the outcomes are predictably poor.
I don’t think you’d find many clinicians in the digital health world to disagree with you around the prescription of controlled substances in purely virtual settings being risky, and requiring many guardrails to pull off in a clinically rigorous and safe manner.
However, the risk here goes beyond just controlled substances, as even companies not prescribing controlled substances likely need local DEA registrations in order to access credentialing and in-network reimbursement for many payer contracts.
Hi Dr. Parikh, I'm not intimately familiar with DEA registration requirements for non-controlled substances but I have no doubt it involves layer upon layer of forms, time, and patience. I'm curious, what kind of new venture prescribing are you referring to, antidepressants?
That's right - antidepressants, or for that matter, any digital health company prescribing any medication for any medical condition (e.g., a cardiac health company prescribing beta-blockers, a diabetes company prescribing metformin, or a weight loss company prescribing GLP1s). Because many payers require a valid DEA registration to credential clinicians, any insurance-based digital health business (in some cases, even if not prescribing any medication) faces potential risk here.
Thank you, that has opened my eyes to an area I'm less familiar with. I'm fairly narrowly focused on non-severe mental illness and addiction treatment and recovery. In this work, I do collaborate with a Physiatrist on heart-rate variability wearables, with the goal being to measure behavioral treatment outcomes. To your point, if I were doing a new digital heart venture, I'd want to be able to leverage NPs, to read EKG's virtually, remotely. Being able to then prescribe beta blockers would boost heart health prevention in a big way. But those NPs are advised to get DEA reg approvals beforehand. Does this example apply to what you are referring to?
Great minds think alike! Clearly this is top of mind for us psychiatrists. My husband's Frontier Psychiatrists substack from today reaches the same conclusion after he had a sobering conversation with the DEA on their impression the PHE is already over in their minds and after we got the communication from PRMS, our malpractice carrier, on this stance. I do think we will see the micro-office-as-a-service plays cropping up and use of the loophole that patients can go to one of those offices and Zoom to their clinician located remotely but licensed in that state to get around the Ryan Haight rule and DEA expectation. I just don't see the DEA moving quickly to modify their position, especially not with all the ADHD and ketamine telehealth only plays that have cropped up when they turned a blind eye during Covid .
Totally agreed. This will likely turn out to be an unexpected moat around D2C digital mental health companies/models that don’t Rx controlled substances and are cash pay only. Who would’ve thought!
This was a great read. I'm from the IT side of things of Telemedicine. I knew there were restrictions based on what state the patient was physically located in, but I didn't know the reasoning. Looking forward to reading more!
Thanks!
There are 150 years of history of harm in the name of help. 100-Billion licit opioid pills shipped jump-started 100K preventable, yearly overdose deaths, yet they are labeled "the opioid problem" like a footnote in venture pitch decks as if reporting a software bug. The digitization of prescribing "at scale", may work for viagra and rogaine (over HIMS). Benzos, gabapentin, and the like were being over-prescribed before covid and the outcomes are predictably poor.
I don’t think you’d find many clinicians in the digital health world to disagree with you around the prescription of controlled substances in purely virtual settings being risky, and requiring many guardrails to pull off in a clinically rigorous and safe manner.
However, the risk here goes beyond just controlled substances, as even companies not prescribing controlled substances likely need local DEA registrations in order to access credentialing and in-network reimbursement for many payer contracts.
Hi Dr. Parikh, I'm not intimately familiar with DEA registration requirements for non-controlled substances but I have no doubt it involves layer upon layer of forms, time, and patience. I'm curious, what kind of new venture prescribing are you referring to, antidepressants?
That's right - antidepressants, or for that matter, any digital health company prescribing any medication for any medical condition (e.g., a cardiac health company prescribing beta-blockers, a diabetes company prescribing metformin, or a weight loss company prescribing GLP1s). Because many payers require a valid DEA registration to credential clinicians, any insurance-based digital health business (in some cases, even if not prescribing any medication) faces potential risk here.
Thank you, that has opened my eyes to an area I'm less familiar with. I'm fairly narrowly focused on non-severe mental illness and addiction treatment and recovery. In this work, I do collaborate with a Physiatrist on heart-rate variability wearables, with the goal being to measure behavioral treatment outcomes. To your point, if I were doing a new digital heart venture, I'd want to be able to leverage NPs, to read EKG's virtually, remotely. Being able to then prescribe beta blockers would boost heart health prevention in a big way. But those NPs are advised to get DEA reg approvals beforehand. Does this example apply to what you are referring to?
Precisely!