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The state of mental health care in the U.S. is at a crossroads, with telehealth prescription waivers set to expire and millions of Americans left without access to crucial treatments. Physician executive Mikkel Hansen shares insights on leveraging data, FDA-cleared tools, and telehealth advancements to standardize ADHD care, ensure patient safety, and advocate for permanent solutions to the growing mental health crisis.
Mikkel Hansen is a physician executive.
He discusses the KevinMD article, “How we can safeguard patients without restricting telehealth access.”
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Transcript
Kevin Pho: Hi, and welcome to the show. Subscribe at kevinemd.com/podcast. Today, we welcome Mikkel Hansen. He’s a physician executive. Today’s Kevin Emdy article is “How We Can Safeguard Patients Without Restricting Telehealth Access.” Mikkel, welcome to the show.
Mikkel Hansen: Thank you, Kevin.
Kevin Pho: So let’s start by briefly sharing your story and journey.
Mikkel Hansen: Yeah, so, I’m a trained physician, completed my medical degree out of Copenhagen University. I’ve been working as a clinician in two different public national health care systems and in one private before I entered R&D roles primarily, first in pharmaceutical and then in the MedTech industry. Most of my work in those positions has always been related to the U.S., and I have based on that a good understanding of the U.S. health care system. I’m now on my fifth year working as a medical director in a small but global medtech company called QB Tech.
Kevin Pho: All right. So let’s talk about your KevinMD article, “How We Can Safeguard Patients Without Restricting Telehealth Access.” Tell us what this article is about for those who didn’t get a chance to read it.
Mikkel Hansen: This article is about our views and concerns on a rollback of the DEA telemedicine waiver. So, there’s a Ryan Haith Act or Consumer Protection Act from 2008 that requires physicians prescribing controlled substances to have a face-to-face visit with their patients before prescribing. There’s been a waiver as a consequence of the pandemic, allowing physicians to disrequire this requirement and prescribe remotely or based on virtual interaction, telemedicine. And this waiver has been extended, and it was about to expire at the end of this year, but there was no clear path forward afterwards.
So, we as a company have been involved quite intensely with the DEA and also the Office of Management and Budgets in order to provide our view and the risks we see. So the article is an outline of these concerns and also potential ways to address or help find a way to safeguard patients and clinicians as well, while allowing for more permanent implementation of telemedicine when prescribing controlled substances.
Kevin Pho: So, for those who aren’t familiar with prescribing controlled behavioral health medications, just tell us what classes or types of medications are involved with what we’re talking about here and how often a patient would need to either telehealth or not see a physician before prescribing or renewing these medications?
Mikkel Hansen: So, there’s various classes of controlled substances, and the one that’s relevant for this talk from our perspective is primarily ADHD medication—so methylphenidate, as an example, which is considered a stimulant and thereby a controlled substance, governed by the DEA. The mandatory face-to-face visit doesn’t relate to actually assessing and diagnosing ADHD; it relates to the right to prescribe. That means that for a patient who has been assessed and diagnosed or is being assessed and diagnosed, in order for them to be able to get a prescription and fill a prescription, they need to go see a health care professional. And it’s a little bit unclear what the actual requirements are and how to document it in this context, but it has the potential to be a massive barrier for patients seeking access to care.
That is outlined in the article as well. If you look at the numbers, there’s around 50 million Americans living with mental health issues, and that’s approximately 350 Americans per mental health provider. And approximately half of the American population lives in mental health care deserts, so to speak, where it’s difficult for them to have access to a face-to-face visit with a provider, meaning that this will, regardless of numbers of visits required, be a logistic barrier, but also a mental barrier for people who are probably already in a situation where they don’t have that many resources to plan, to coordinate, and to travel.
One of the interesting things in this context is that this Consumer Protection Act was implemented in 2008, and FaceTime was implemented in 2010. So a lot of things have happened since this act was enforced.
Kevin Pho: One of the things that you mentioned earlier was that this waiver has been extended several times since 2008. So what makes you think that now it may not be extended? What has changed?
Mikkel Hansen: Yeah, and that’s actually the interesting part. And that’s what I think is important also to inform the audience about, is that on the date of the publication of this article that we’re talking about today, the DEA also published another extension until 2025 of this waiver. So, they prolonged it another year and did some minor changes. And that is probably in the light of more than 30,000 comments they received and multiple partakings in hearings and listening sessions, also from QB Tech, representing a leader in objective testing in ADHD. And maybe also in anticipation of a change of government coming up, right? So, they extended another year, and what I found interesting in that text of the extension is that they are highlighting that this year will be spent finding permanent solutions, hence not just a rollback to how it was before. So potentially, there’s a door open for collaborating around finding practical solutions that ensure that we implement safeguards but at the same time are not limiting access to care for a large proportion of Americans.
Kevin Pho: Now, you mentioned that the DEA has been having listening sessions where they’re gathering some public feedback for the potential expiration of these waivers. Do you know what some of that feedback is? What are some people seeing during these listening sessions?
Mikkel Hansen: One of the important parts is that you cannot just look at controlled substances as one group. And I think it was also clear how many people are actually dependent on these and how much it will impact their lives, both the practicalities of doing a face-to-face visit but, more importantly, if they do not manage to do that and they won’t get their medication.
Turning to ADHD, which I think all clinicians have been exposed to in some shape or form, we see that there’s a growing number of people being diagnosed with ADHD. There’s even increasing numbers of self-diagnosing, driven by all sorts of things—maybe increased awareness, maybe TikTok videos, and so on and so forth. And it’s a tricky thing. So I understand why you don’t just want to have an open door for prescribing medication for everyone who might have ADHD or who are difficult to really convince that they do not have ADHD, but more importantly is to ensure that the ones who are really burdened by the symptoms and it has an impact on the quality of life, on their life expectancy, on potential criminal violations, on educational levels, and general health, that they get the care they need. And as I mentioned, they are typically less able to structure and plan a face-to-face visit.
So I think putting that focus on a specific patient group was picked up, and we were invited for additional calls and listening sessions afterward. But honestly, I think that the authorities in this field are overwhelmed by the feedback, and just processing more than 30,000 comments takes a long time.
Kevin Pho: So tell us the role of how data and technology can help with this issue in terms of targeting the right patient populations. Tell us the role of data and technology.
Mikkel Hansen: Yeah, so I think I’ll start with ADHD and just summarize a little bit there, because ADHD is a clinical diagnosis, and that means that there is no measure—no objective measure—as part of the diagnostic criteria. So, in essence, you have a couple of rule-in criteria that relate to symptom levels, and then you have three rule-out criteria that relate to symptoms having been present before the age of 12, that your symptoms are impacting your well-being in more than one life setting—so that could be work and home or school and home—and that there’s no other diagnosis that’s better explaining your symptoms.
But all of this relates to a patient’s perception of themselves, how they see themselves compared to others, their interpretation of different words and questionnaires asked by the physician, and it also depends on the clinician’s perception of the diagnostic criteria. So what does it mean if you have a hard time sitting still often or very often? That’s relative. It’s not quantifiable, and one clinician might have one level of making a decision—”Is this often or very often?”—where another clinician would have another definition or mental threshold. So it’s subjective information, either provided by questionnaires or verbally from the patient, to a clinician who is also, in essence, doing a subjective evaluation of this information.
So where technology comes in—and we at QB Tech, we’ve been working in this field for 20 years. We are active in 44 states in the U.S., 14 countries. We have actually just reached patient number 1,000,000 being tested by one of our objective tests, and we’ve worked with more than 10,000 clinicians. So we’re pretty into this area, and our mission is to improve the lives of people living with ADHD. We take that pretty seriously. But coming back to the technology part: Our tests measure the three cardinal symptom domains in ADHD, so it’s hyperactivity, it’s impulsivity, and it’s inattention.
We do so by a laptop-based test or a combination of software and hardware, but the common theme in both tests is the visual presentation of stimuli. So every other second, you’ll have a new stimulus, and if you’re an adult, you need to remember the previous stimulus, and then you have to press a trigger if it’s the same. So there’s a recall element to it. For children, they just need to present the correct stimulus. And this test takes 15 minutes for kids, 20 minutes for adults. So it’s pretty boring. I have done it many times myself as part of my role. It is quite boring. So it’s difficult to cope with sustained attention for such a long period of time. And while you’re doing the test, we are, of course, recording your responses, so we can measure your error rate, but we’re also recording your activity levels. We’re pretty unique in that field because we also measure your activity levels. So you might be able to cope and have not too many errors, but then you’re most likely moving around a lot.
And we also have a database generated from background population in a similar setting, so it’s comparable. So you actually are provided with a score and a comparison to same-month age and also sex at birth. So we provide the clinicians with a tool to standardize or compare and reduce some of the biases that might be introduced. And we measure every 16th or 20th millisecond, so we have a lot of data points. We are cleared by the FDA for the aid in assessment and treatment monitoring in ADHD. And I think in this case, it’s quite relevant with the treatment monitoring, because we see that two hours after taking methylphenidate, we can see a significant response; we can see a significant improvement in your symptom levels when it comes to how much you move, how you respond, your reaction time, and variation in your reaction time. That’s an objective measure that’s consistent, and we can even see circadian variation. We see those dependencies. We see that if you do this immediately after or the next day, three months after or six months after, we have the same ability to measure the impact of medication.
So this is a potential safeguard that can be implemented as a requirement—that you might get a prescription, but we need to see documentation that this medication is actually relevant for you in order to keep that prescription. And that is not dependent on a face-to-face visit. A face-to-face visit is basically dependent on a talk or questionnaires between the patient and the clinician. As outlined previously, questionnaires have the limitations of being subjective, and they are not designed for tracking treatment effect. So technology can come in and really objectify and standardize how you treat patients, monitor treatment effect, and it can easily be done. In fact, it’s most often done on a platform that enables virtual monitoring.
Kevin Pho: Now, you mentioned that these waivers keep having to be renewed, and you talk about a potential permanent solution. What is the permanent solution that you would like to see for this?
Mikkel Hansen: So I think that, of course, this act is there to avoid misusage of controlled substances, but if we turn it around and say, “What is it that we want to achieve?” we want to achieve the right diagnosis, we want to achieve the right treatment, actually the right improvement by treatment, for the right patient, and also ensure that prescriptions are filled as intended. So the last one, in my view—also having worked in European health care systems—can only really be addressed by a central federal prescription database or registry that’ll safeguard the clinicians because they’ll have the opportunity to see what other medication this patient has been prescribed. That transparency doesn’t really exist now, as I understand it, because different ecosystems have different registries, but a patient can shop around. So if they want to misuse the system, they’re able to do so.
When it comes to the right diagnosis and when it comes to the right way of monitoring treatment effect, technology plays a role. I strongly believe that it’s time to start implementing objective measures. Somewhat vague improvement measured by subjective measures—we know the limitations. We know that if a patient believes they’re improving, they will report that they’re improving, but it’s potential placebo. And there’s also the potential that if you know the diagnostic criteria and what your clinician is looking for, you can just respond as they would expect you to respond to stay on medication or to get the diagnosis. So you can trick the system, and there’s no real safeguard against that as it is now.
So for the diagnosis of ADHD, it’s the same issue that you can trick the system by giving the right responses. And I don’t believe that a face-to-face visit will help that. I think, to some extent, it’s more difficult for a clinician to negate a very convincing patient who has answered all the right things—or the wrong things, however you put it—reports symptoms in childhood and that this impacts their lives in different ways. It’s difficult for a clinician wanting to help to negate that, but having objective measures compared to peers and showing, “You might believe that you have ADHD, but if you look at your performance in an objective test, you’re doing really well,” that’ll facilitate that. So I think a more permanent solution should definitely include objective measures.
Kevin Pho: We’re talking to Mikkel Hansen. He’s a physician executive. Today’s KevinMD article is “How We Can Safeguard Patients Without Restricting Telehealth Access.” Mikkel, let’s end with some short take-home messages that you want to leave with the KevinMD audience.
Mikkel Hansen: Yeah, I think if we want to implement effective safeguards in telemedicine, I strongly believe it requires transparent collaboration, and for ADHD specifically, relevant objective data is needed for proper treatment monitoring. I do not believe a face-to-face visit in itself will solve this, but I also believe that, given the attention that ADHD is getting, objective data is also needed for standardization of the assessment process, for negating self-diagnosis, and for supporting meaningful research in the field. Hopefully, we can then gradually increase the robustness of what we define as ADHD and improvement from treatment.
Kevin Pho: Mikkel, thank you so much for sharing your perspective and insight. Thanks again for coming on the show.
Mikkel Hansen: Thank you for having me. It was a pleasure.
